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How to do legal research in 3 steps

Knowing where to start a difficult legal research project can be a challenge. But if you already understand the basics of legal research, the process can be significantly easier — not to mention quicker.

Solid research skills are crucial to crafting a winning argument. So, whether you are a law school student or a seasoned attorney with years of experience, knowing how to perform legal research is important — including where to start and the steps to follow.

What is legal research, and where do I start? 

Black's Law Dictionary defines legal research as “[t]he finding and assembling of authorities that bear on a question of law." But what does that actually mean? It means that legal research is the process you use to identify and find the laws — including statutes, regulations, and court opinions — that apply to the facts of your case.

In most instances, the purpose of legal research is to find support for a specific legal issue or decision. For example, attorneys must conduct legal research if they need court opinions — that is, case law — to back up a legal argument they are making in a motion or brief filed with the court.

Alternatively, lawyers may need legal research to provide clients with accurate legal guidance . In the case of law students, they often use legal research to complete memos and briefs for class. But these are just a few situations in which legal research is necessary.

Why is legal research hard?

Each step — from defining research questions to synthesizing findings — demands critical thinking and rigorous analysis.

1. Identifying the legal issue is not so straightforward. Legal research involves interpreting many legal precedents and theories to justify your questions. Finding the right issue takes time and patience.

2. There's too much to research. Attorneys now face a great deal of case law and statutory material. The sheer volume forces the researcher to be efficient by following a methodology based on a solid foundation of legal knowledge and principles.

3. The law is a fluid doctrine. It changes with time, and staying updated with the latest legal codes, precedents, and statutes means the most resourceful lawyer needs to assess the relevance and importance of new decisions.

Legal research can pose quite a challenge, but professionals can improve it at every stage of the process . 

Step 1: Key questions to ask yourself when starting legal research

Before you begin looking for laws and court opinions, you first need to define the scope of your legal research project. There are several key questions you can use to help do this.

What are the facts?

Always gather the essential facts so you know the “who, what, why, when, where, and how” of your case. Take the time to write everything down, especially since you will likely need to include a statement of facts in an eventual filing or brief anyway. Even if you don't think a fact may be relevant now, write it down because it may be relevant later. These facts will also be helpful when identifying your legal issue.

What is the actual legal issue?

You will never know what to research if you don't know what your legal issue is. Does your client need help collecting money from an insurance company following a car accident involving a negligent driver? How about a criminal case involving excluding evidence found during an alleged illegal stop?

No matter the legal research project, you must identify the relevant legal problem and the outcome or relief sought. This information will guide your research so you can stay focused and on topic.

What is the relevant jurisdiction?

Don't cast your net too wide regarding legal research; you should focus on the relevant jurisdiction. For example, does your case deal with federal or state law? If it is state law, which state? You may find a case in California state court that is precisely on point, but it won't be beneficial if your legal project involves New York law.

Where to start legal research: The library, online, or even AI?

In years past, future attorneys were trained in law school to perform research in the library. But now, you can find almost everything from the library — and more — online. While you can certainly still use the library if you want, you will probably be costing yourself valuable time if you do.

When it comes to online research, some people start with free legal research options , including search engines like Google or Bing. But to ensure your legal research is comprehensive, you will want to use an online research service designed specifically for the law, such as Westlaw . Not only do online solutions like Westlaw have all the legal sources you need, but they also include artificial intelligence research features that help make quick work of your research

Step 2: How to find relevant case law and other primary sources of law

Now that you have gathered the facts and know your legal issue, the next step is knowing what to look for. After all, you will need the law to support your legal argument, whether providing guidance to a client or writing an internal memo, brief, or some other legal document.

But what type of law do you need? The answer: primary sources of law. Some of the more important types of primary law include:

• Case law, which are court opinions or decisions issued by federal or state courts
• Statutes, including legislation passed by both the U.S. Congress and state lawmakers
• Regulations, including those issued by either federal or state agencies
• Constitutions, both federal and state

Searching for primary sources of law

So, if it's primary law you want, it makes sense to begin searching there first, right? Not so fast. While you will need primary sources of law to support your case, in many instances, it is much easier — and a more efficient use of your time — to begin your search with secondary sources such as practice guides, treatises, and legal articles.

Why? Because secondary sources provide a thorough overview of legal topics, meaning you don't have to start your research from scratch. After secondary sources, you can move on to primary sources of law.

For example, while no two legal research projects are the same, the order in which you will want to search different types of sources may look something like this:

• Secondary sources . If you are researching a new legal principle or an unfamiliar area of the law, the best place to start is secondary sources, including law journals, practice guides , legal encyclopedias, and treatises. They are a good jumping-off point for legal research since they've already done the work for you. As an added bonus, they can save you additional time since they often identify and cite important statutes and seminal cases.
• Case law . If you have already found some case law in secondary sources, great, you have something to work with. But if not, don't fret. You can still search for relevant case law in a variety of ways, including running a search in a case law research tool.

Once you find a helpful case, you can use it to find others. For example, in Westlaw, most cases contain headnotes that summarize each of the case's important legal issues. These headnotes are also assigned a Key Number based on the topic associated with that legal issue. So, once you find a good case, you can use the headnotes and Key Numbers within it to quickly find more relevant case law.

• Statutes and regulations . In many instances, secondary sources and case law list the statutes and regulations relevant to your legal issue. But if you haven't found anything yet, you can still search for statutes and regs online like you do with cases.

Once you know which statute or reg is pertinent to your case, pull up the annotated version on Westlaw. Why the annotated version? Because the annotations will include vital information, such as a list of important cases that cite your statute or reg. Sometimes, these cases are even organized by topic — just one more way to find the case law you need to support your legal argument.

Keep in mind, though, that legal research isn't always a linear process. You may start out going from source to source as outlined above and then find yourself needing to go back to secondary sources once you have a better grasp of the legal issue. In other instances, you may even find the answer you are looking for in a source not listed above, like a sample brief filed with the court by another attorney. Ultimately, you need to go where the information takes you.

Step 3: Make sure you are using ‘good’ law

One of the most important steps with every legal research project is to verify that you are using “good" law — meaning a court hasn't invalidated it or struck it down in some way. After all, it probably won't look good to a judge if you cite a case that has been overruled or use a statute deemed unconstitutional. It doesn't necessarily mean you can never cite these sources; you just need to take a closer look before you do.

The simplest way to find out if something is still good law is to use a legal tool known as a citator, which will show you subsequent cases that have cited your source as well as any negative history, including if it has been overruled, reversed, questioned, or merely differentiated.

For instance, if a case, statute, or regulation has any negative history — and therefore may no longer be good law — KeyCite, the citator on Westlaw, will warn you. Specifically, KeyCite will show a flag or icon at the top of the document, along with a little blurb about the negative history. This alert system allows you to quickly know if there may be anything you need to worry about.

Some examples of these flags and icons include:

• A red flag on a case warns you it is no longer good for at least one point of law, meaning it may have been overruled or reversed on appeal.
• A yellow flag on a case warns that it has some negative history but is not expressly overruled or reversed, meaning another court may have criticized it or pointed out the holding was limited to a specific fact pattern.
• A blue-striped flag on a case warns you that it has been appealed to the U.S. Supreme Court or the U.S. Court of Appeals.
• The KeyCite Overruling Risk icon on a case warns you that the case may be implicitly undermined because it relies on another case that has been overruled.

Another bonus of using a citator like KeyCite is that it also provides a list of other cases that merely cite your source — it can lead to additional sources you previously didn't know about.

Perseverance is vital when it comes to legal research

Given that legal research is a complex process, it will likely come as no surprise that this guide cannot provide everything you need to know.

There is a reason why there are entire law school courses and countless books focused solely on legal research methodology. In fact, many attorneys will spend their entire careers honing their research skills — and even then, they may not have perfected the process.

So, if you are just beginning, don't get discouraged if you find legal research difficult — almost everyone does at first. With enough time, patience, and dedication, you can master the art of legal research.

Thomson Reuters originally published this article on November 10, 2020.

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How to Conduct Legal Research

September 21, 2021

Conducting legal research can challenge even the most skilled law practitioners.

As laws evolve across jurisdictions, it can be a difficult to keep pace with every legal development. Equally daunting is the ability to track and glean insights into stakeholder strategies and legal responses. Without quick and easy access to the right tools, the legal research upon which case strategy hinges may face cost, personnel, and litigation outcome challenges.

Bloomberg Law’s artificial intelligence-driven tools drastically reduce the time to perform legal research. Whether you seek quick answers to legal research definitions, or general guidance on the legal research process, Bloomberg Law’s Core Litigation Skills Toolkit has you covered.

What is legal research?

Legal research is the process of uncovering and understanding all of the legal precedents, laws, regulations, and other legal authorities that apply in a case and inform an attorney’s course of action.

Legal research often involves case law research, which is the practice of identifying and interpreting the most relevant cases concerning the topic at issue. Legal research can also involve a deep dive into a judge’s past rulings or opposing counsel’s record of success.

Research is not a process that has a finite start and end, but remains ongoing throughout every phase of a legal matter. It is a cornerstone of a litigator’s skills.

[Learn how our integrated, time-saving litigation research tools allow litigators to streamline their work and get answers quickly.]

Where do I begin my legal research?

Beginning your legal research will look different for each assignment. At the outset, ensure that you understand your goal by asking questions and taking careful notes. Ask about background case information, logistical issues such as filing deadlines, the client/matter number, and billing instructions.

It’s also important to consider how your legal research will be used. Is the research to be used for a pending motion? If you are helping with a motion for summary judgment, for example, your goal is to find cases that are in the same procedural posture as yours and come out favorably for your side (i.e., if your client is the one filing the motion, try to find cases where a motion for summary judgment was granted, not denied). Keep in mind the burden of proof for different kinds of motions.

Finally, but no less important, assess the key facts of the case. Who are the relevant parties? Where is the jurisdiction? Who is the judge? Note all case details that come to mind.

What if I’m new to the practice area or specific legal issue?

While conducting legal research, it is easy to go down rabbit holes. Resist the urge to start by reviewing individual cases, which may prove irrelevant. Start instead with secondary sources, which often provide a prevailing statement of the law for a specific topic. These sources will save time and orient you to the area of the law and key issues.

Litigation Practical Guidance provides the essentials including step-by-step guidance, expert legal analysis, and a preview of next steps. Source citations are included in all Practical Guidance, and you can filter Points of Law, Smart Code®, and court opinions searches to get the jurisdiction-specific cases or statutes you need.

Searching across Points of Law will help to get your bearings on an issue before diving into reading the cases in full. Points of Law uses machine learning to identify key legal principles expressed in court opinions, which are easily searchable by keyword and jurisdiction. This tool helps you quickly find other cases that have expressed the same Point of Law, and directs you to related Points of Law that might be relevant to your research. It is automatically updated with the most recent opinions, saving you time and helping you quickly drill down to the relevant cases.

How do I respond to the opposing side’s brief?

Whether a brief is yours or that of the opposing party, Bloomberg Law’s Brief Analyzer is an essential component in the legal research process. It reduces the time spent analyzing a brief, identifying relevant authorities, and preparing a solid response.

To start, navigate to Brief Analyzer available from the Bloomberg Law homepage, within the Litigation Intelligence Center , or from Docket Key search results for briefs.

Simply upload the opposing side’s brief into the tool, and Brief Analyzer will generate a report of the cited authorities and arguments contained in the brief.

You can easily view a comparison with the brief and analysis side by side. It will also point you directly to relevant cases, Points of Law, and Practical Guidance to jump start your research.

[ How to Write a Legal Brief – Learn how to shorten the legal research cycle and give your legal brief a competitive advantage.]

How to optimize your search.

Crafting searches is a critical skill when it comes to legal research. Although many legal research platforms, including Bloomberg Law, offer natural language searching, terms and connectors (also called Boolean) searching is still a vital legal research skill and should be used when searching across court opinions, dockets, Points of Law, and other primary and secondary sources.

When you conduct a natural language search, the search engine applies algorithms to rank your results. Why a certain case is ranked as it is may not be obvious. This makes it harder to interpret whether the search is giving you everything you need. It is also harder to efficiently and effectively manipulate your search terms to zero in on the results you want. Using Boolean searching gives you better control over your search and greater confidence in your results.

The good news? Bloomberg Law does not charge by the search for court opinion searches. If your initial search was much too broad or much too narrow, you do not have to worry about immediately running a new and improved search.

Follow these tips when beginning a search to ensure that you do not miss relevant materials:

• Make sure you do not have typos in your search string.
• Search the appropriate source or section of the research platform. It is possible to search only within a practice area, jurisdiction, secondary resource, or other grouping of materials.
• Make sure you know which terms and connectors are utilized by the platform you are working on and what they mean – there is no uniform standard set of terms of connectors utilized by all platforms.
• Include in your search all possible terms the court might use, or alternate ways the court may address an issue. It is best to group the alternatives together within a parenthetical, connected by OR between each term.
• Consider including single and multiple character wildcards when relevant. Using a single character wildcard (an asterisk) and/or a multiple character wildcard (an exclamation point) helps you capture all word variations – even those you might not have envisioned.
• Try using a tool that helps you find additional relevant case law. When you find relevant authority, use BCITE on Bloomberg Law to find all other cases and/or sources that cite back to that case. When in BCITE, click on the Citing Documents tab, and search by keyword to narrow the results. Alternatively, you can use the court’s language or ruling to search Points of Law and find other cases that addressed the same issue or reached the same ruling.

[Bloomberg Law subscribers can access a complete checklist of search term best practices . Not a subscriber? Request a Demo .]

How can legal research help with drafting or strategy?

Before drafting a motion or brief, search for examples of what firm lawyers filed with the court in similar cases. You can likely find recent examples in your firm’s internal document system or search Bloomberg Law’s dockets. If possible, look for things filed before the same judge so you can get a quick check on rules/procedures to be followed (and by the same partner when possible so you can get an idea of their style preferences).

Careful docket search provides a wealth of information about relevant cases, jurisdictions, judges, and opposing counsel. On Bloomberg Law, type “Dockets Search” in the Go bar or find the dockets search box in the Litigation Intelligence Center .

If you do not know the specific docket number and/or court, use the docket search functionality Docket Key . Select from any of 20 categories, including motions, briefs, and orders, across all 94 federal district courts, to pinpoint the exact filing of choice.

Dockets can also help you access lots of information to guide your case strategy. For example, if you are considering filing a particular type of motion, such as a sanctions motion, you can use dockets to help determine how frequently your judge grants sanctions motions. You can also use dockets to see how similar cases before your judge proceeded through discovery.

If you are researching expert witnesses, you can use dockets to help determine if the expert has been recently excluded from a case, or whether their opinion has been limited. If so, this will help you determine whether the expert is a good fit for your case.

Dockets are a powerful research tool that allow you to search across filings to support your argument. Stay apprised of docket updates with the “Create Alert” option on Bloomberg Law.

Dive deeper into competitive research.

For even more competitive research insights, dive into Bloomberg Law’s Litigation Analytics – this is available in the Litigation tab on the homepage. Data here helps attorneys develop litigation strategy, predict possible outcomes, and better advise clients.

To start, under Litigation Analytics , leverage the Attorney tab to view case history and preview legal strategies the opposition may practice against you. Also, within Litigation Analytics, use the Court tab to get aggregate motion and appeal outcome rates across all federal courts, with the option to run comparisons across jurisdictions, and filter by company, law firm, and attorney.

Use the Judge tab to glean insights from cited opinions, and past and current decisions by motion and appeal outcomes. Also view litigation analytics in the right rail of court opinions.

Docket search can also offer intel on your opponent. Has your opponent filed similar lawsuits or made similar arguments before? How did those cases pan out? You can learn a lot about an opponent from past appearances in court.

How do I validate case law citations?

Checking the status of case law is essential in legal research. Rely on Bloomberg Law’s proprietary citator, BCITE. This time-saving tool lets you know if a case is still good law.

Under each court opinion, simply look to the right rail. There, you will see a thumbnail icon for “BCITE Analysis.” Click on the icon, and you will be provided quick links to direct history (opinions that affect or are affected by the outcome of the case at issue); case analysis (citing cases, with filter and search options), table of authorities, and citing documents.

How should I use technology to improve my legal research?

A significant benefit of digital research platforms and analytics is increased efficiency. Modern legal research technology helps attorneys sift through thousands of cases quickly and comprehensively. These products can also help aggregate or summarize data in a way that is more useful and make associations instantaneously.

For example, before litigation analytics were common, a partner may have asked a junior associate to find all summary judgment motions ruled on by a specific judge to determine how often that judge grants or denies them. The attorney could have done so by manually searching over PACER and/or by searching through court opinions, but that would take a long time. Now, Litigation Analytics can aggregate that data and provide an answer in seconds. Understanding that such products exist can be a game changer. Automating parts of the research process frees up time and effort for other activities that benefit the client and makes legal research and writing more efficient.

[Read our article: Six ways legal technology aids your litigation workflow .]

Tools like  Points of Law ,  dockets  and  Brief Analyzer  can also increase efficiency, especially when narrowing your research to confirm that you found everything on point. In the past, attorneys had to spend many hours (and lots of money) running multiple court opinion searches to ensure they did not miss a case on point. Now, there are tools that can dramatically speed up that process. For example, running a search over Points of Law can immediately direct you to other cases that discuss that same legal principle.

However, it’s important to remember that digital research and analytical tools should be seen as enhancing the legal research experience, not displacing the review, analysis, and judgment of an attorney. An attorney uses his or her knowledge of their client, the facts, the precedent, expert opinions, and his or her own experiences to predict the likely result in a given matter. Digital research products enhance this process by providing more data on a wider array of variables so that an attorney can take even more information into consideration.

[Get all your questions answered, request a Bloomberg Law demo , and more.]

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• A-Z Publications

Annual Review of Law and Social Science

Volume 14, 2018, review article, the use of case studies in law and social science research.

• Lisa L. Miller 1
• View Affiliations Hide Affiliations Affiliations: Department of Political Science, Rutgers University, New Brunswick, New Jersey 08901, USA; email: [email protected]
• Vol. 14:381-396 (Volume publication date October 2018) https://doi.org/10.1146/annurev-lawsocsci-120814-121513
• Copyright © 2018 by Annual Reviews. All rights reserved

This article reviews classic and contemporary case study research in law and social science. Taking as its starting point that legal scholars engaged in case studies generally have a set of questions distinct from those using other research approaches, the essay offers a detailed discussion of three primary contributions of case studies in legal scholarship: theory building, concept formation, and processes/mechanisms. The essay describes the role of case studies in social scientific work and their express value to legal scholars, and offers specific descriptions from classic and contemporary works.

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22 Case Study Research: In-Depth Understanding in Context

Helen Simons, School of Education, University of Southampton

• Published: 01 July 2014
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This chapter explores case study as a major approach to research and evaluation. After first noting various contexts in which case studies are commonly used, the chapter focuses on case study research directly Strengths and potential problematic issues are outlined and then key phases of the process. The chapter emphasizes how important it is to design the case, to collect and interpret data in ways that highlight the qualitative, to have an ethical practice that values multiple perspectives and political interests, and to report creatively to facilitate use in policy making and practice. Finally, it explores how to generalize from the single case. Concluding questions center on the need to think more imaginatively about design and the range of methods and forms of reporting requiredto persuade audiences to value qualitative ways of knowing in case study research.

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Legal Research Strategy

Preliminary analysis, organization, secondary sources, primary sources, updating research, identifying an end point, getting help, about this guide.

This guide will walk a beginning researcher though the legal research process step-by-step. These materials are created with the 1L Legal Research & Writing course in mind. However, these resources will also assist upper-level students engaged in any legal research project.

How to Strategize

Legal research must be comprehensive and precise.  One contrary source that you miss may invalidate other sources you plan to rely on.  Sticking to a strategy will save you time, ensure completeness, and improve your work product. 

Follow These Steps

Running Time: 3 minutes, 13 seconds.

Make sure that you don't miss any steps by using our:

• Legal Research Strategy Checklist

If you get stuck at any time during the process, check this out:

• Ten Tips for Moving Beyond the Brick Wall in the Legal Research Process, by Marsha L. Baum

Understanding the Legal Questions

A legal question often originates as a problem or story about a series of events. In law school, these stories are called fact patterns. In practice, facts may arise from a manager or an interview with a potential client. Start by doing the following:

• Read anything you have been given
• Analyze the facts and frame the legal issues
• Assess what you know and need to learn
• Note the jurisdiction and any primary law you have been given
• Generate potential search terms

Jurisdiction

Legal rules will vary depending on where geographically your legal question will be answered. You must determine the jurisdiction in which your claim will be heard. These resources can help you learn more about jurisdiction and how it is determined:

• Legal Treatises on Jurisdiction
• LII Wex Entry on Jurisdiction

This map indicates which states are in each federal appellate circuit:

Getting Started

Once you have begun your research, you will need to keep track of your work. Logging your research will help you to avoid missing sources and explain your research strategy. You will likely be asked to explain your research process when in practice. Researchers can keep paper logs, folders on Westlaw or Lexis, or online citation management platforms.

Organizational Methods

Tracking with paper or excel.

Many researchers create their own tracking charts.  Be sure to include:

• Search Date
• Topics/Keywords/Search Strategy
• Citation to Relevant Source Found
• Save Locations
• Follow Up Needed

Consider using the following research log as a starting place: 

• Sample Research Log

Tracking with Folders

Westlaw and Lexis offer options to create folders, then save and organize your materials there.

• Lexis Advance Folders
• Westlaw Edge Folders

Tracking with Citation Management Software

For long term projects, platforms such as Zotero, EndNote, Mendeley, or Refworks might be useful. These are good tools to keep your research well organized. Note, however, that none of these platforms substitute for doing your own proper Bluebook citations. Learn more about citation management software on our other research guides:

• Guide to Zotero for Harvard Law Students by Harvard Law School Library Research Services Last Updated Sep 12, 2023 365 views this year

Types of Sources

There are three different types of sources: Primary, Secondary, and Tertiary.  When doing legal research you will be using mostly primary and secondary sources.  We will explore these different types of sources in the sections below.

Secondary sources often explain legal principles more thoroughly than a single case or statute. Starting with them can help you save time.

Secondary sources are particularly useful for:

• Learning the basics of a particular area of law
• Understanding key terms of art in an area
• Identifying essential cases and statutes

Consider the following when deciding which type of secondary source is right for you:

• Scope/Breadth
• Depth of Treatment
• Currentness/Reliability

For a deep dive into secondary sources visit:

• Secondary Sources: ALRs, Encyclopedias, Law Reviews, Restatements, & Treatises by Catherine Biondo Last Updated Apr 12, 2024 5925 views this year

Legal Dictionaries & Encyclopedias

Legal dictionaries.

Legal dictionaries are similar to other dictionaries that you have likely used before.

• Black's Law Dictionary
• Ballentine's Law Dictionary

Legal Encyclopedias

Legal encyclopedias contain brief, broad summaries of legal topics, providing introductions and explaining terms of art. They also provide citations to primary law and relevant major law review articles.  

Here are the two major national encyclopedias:

• American Jurisprudence (AmJur) This resource is also available in Westlaw & Lexis .
• Corpus Juris Secundum (CJS)

Treatises are books on legal topics.  These books are a good place to begin your research.  They provide explanation, analysis, and citations to the most relevant primary sources. Treatises range from single subject overviews to deep treatments of broad subject areas.

It is important to check the date when the treatise was published. Many are either not updated, or are updated through the release of newer editions.

To find a relevant treatise explore:

• Legal Treatises by Subject by Catherine Biondo Last Updated Apr 12, 2024 5418 views this year

American Law Reports (ALR)

American Law Reports (ALR) contains in-depth articles on narrow topics of the law. ALR articles, are often called annotations. They provide background, analysis, and citations to relevant cases, statutes, articles, and other annotations. ALR annotations are invaluable tools to quickly find primary law on narrow legal questions.

This resource is available in both Westlaw and Lexis:

• American Law Reports on Westlaw (includes index)
• American Law Reports on Lexis

Law Reviews & Journals

Law reviews are scholarly publications, usually edited by law students in conjunction with faculty members. They contain both lengthy articles and shorter essays by professors and lawyers. They also contain comments, notes, or developments in the law written by law students. Articles often focus on new or emerging areas of law and may offer critical commentary. Some law reviews are dedicated to a particular topic while others are general. Occasionally, law reviews will include issues devoted to proceedings of panels and symposia.

Law review and journal articles are extremely narrow and deep with extensive references. 

To find law review articles visit:

• Law Journal Library on HeinOnline
• Law Reviews & Journals on LexisNexis
• Law Reviews & Journals on Westlaw

Restatements

Restatements are highly regarded distillations of common law, prepared by the American Law Institute (ALI). ALI is a prestigious organization comprised of judges, professors, and lawyers. They distill the "black letter law" from cases to indicate trends in common law. Resulting in a “restatement” of existing common law into a series of principles or rules. Occasionally, they make recommendations on what a rule of law should be.

Restatements are not primary law. However, they are considered persuasive authority by many courts.

Restatements are organized into chapters, titles, and sections.  Sections contain the following:

• a concisely stated rule of law,
• comments to clarify the rule,
• hypothetical examples,
• explanation of purpose, and
• exceptions to the rule  

To access restatements visit:

• American Law Institute Library on HeinOnline
• Restatements & Principles of the Law on LexisNexis
• Restatements & Principles of Law on Westlaw

Primary Authority

Primary authority is "authority that issues directly from a law-making body."   Authority , Black's Law Dictionary (11th ed. 2019).   Sources of primary authority include:

• Constitutions
• Statutes 

Regulations

Access to primary legal sources is available through:

• Bloomberg Law
• Free & Low Cost Alternatives

Statutes (also called legislation) are "laws enacted by legislative bodies", such as Congress and state legislatures.  Statute , Black's Law Dictionary (11th ed. 2019).

We typically start primary law research here. If there is a controlling statute, cases you look for later will interpret that law. There are two types of statutes, annotated and unannotated.

Annotated codes are a great place to start your research. They combine statutory language with citations to cases, regulations, secondary sources, and other relevant statutes. This can quickly connect you to the most relevant cases related to a particular law. Unannotated Codes provide only the text of the statute without editorial additions. Unannotated codes, however, are more often considered official and used for citation purposes.

For a deep dive on federal and state statutes, visit:

• Statutes: US and State Codes by Mindy Kent Last Updated Apr 12, 2024 4320 views this year
• 50 State Surveys

Want to learn more about the history or legislative intent of a law?  Learn how to get started here:

• Legislative History Get an introduction to legislative histories in less than 5 minutes.
• Federal Legislative History Research Guide

Regulations are rules made by executive departments and agencies. Not every legal question will require you to search regulations. However, many areas of law are affected by regulations. So make sure not to skip this step if they are relevant to your question.

To learn more about working with regulations, visit:

• Administrative Law Research by AJ Blechner Last Updated Apr 12, 2024 766 views this year

Case Basics

In many areas, finding relevant caselaw will comprise a significant part of your research. This Is particularly true in legal areas that rely heavily on common law principles.

Running Time: 3 minutes, 10 seconds.

Unpublished Cases

Up to  86% of federal case opinions are unpublished. You must determine whether your jurisdiction will consider these unpublished cases as persuasive authority. The Federal Rules of Appellate Procedure have an overarching rule, Rule 32.1  Each circuit also has local rules regarding citations to unpublished opinions. You must understand both the Federal Rule and the rule in your jurisdiction.

• Federal and Local Rules of Appellate Procedure 32.1 (Dec. 2021).
• Type of Opinion or Order Filed in Cases Terminated on the Merits, by Circuit (Sept. 2021).

Each state also has its own local rules which can often be accessed through:

• State Bar Associations
• State Courts Websites

First Circuit

• First Circuit Court Rule 32.1.0

Second Circuit

• Second Circuit Court Rule 32.1.1

Third Circuit

• Third Circuit Court Rule 5.7

Fourth Circuit

• Fourth Circuit Court Rule 32.1

Fifth Circuit

• Fifth Circuit Court Rule 47.5

Sixth Circuit

• Sixth Circuit Court Rule 32.1

Seventh Circuit

• Seventh Circuit Court Rule 32.1

Eighth Circuit

• Eighth Circuit Court Rule 32.1A

Ninth Circuit

• Ninth Circuit Court Rule 36-3

Tenth Circuit

• Tenth Circuit Court Rule 32.1

Eleventh Circuit

• Eleventh Circuit Court Rule 32.1

D.C. Circuit

• D.C. Circuit Court Rule 32.1

Federal Circuit

• Federal Circuit Court Rule 32.1

Finding Cases

Headnotes show the key legal points in a case. Legal databases use these headnotes to guide researchers to other cases on the same topic. They also use them to organize concepts explored in cases by subject. Publishers, like Westlaw and Lexis, create headnotes, so they are not consistent across databases.

Headnotes are organized by subject into an outline that allows you to search by subject. This outline is known as a "digest of cases." By browsing or searching the digest you can retrieve all headnotes covering a particular topic. This can help you identify particularly important cases on the relevant subject.

Running Time: 4 minutes, 43 seconds.

Each major legal database has its own digest:

• Topic Navigator (Lexis)
• Key Digest System (Westlaw)

Start by identifying a relevant topic in a digest.  Then you can limit those results to your jurisdiction for more relevant results.  Sometimes, you can keyword search within only the results on your topic in your jurisdiction.  This is a particularly powerful research method.

One Good Case Method

After following the steps above, you will have identified some relevant cases on your topic. You can use good cases you find to locate other cases addressing the same topic. These other cases often apply similar rules to a range of diverse fact patterns.

• in Lexis click "More Like This Headnote"
• in Westlaw click "Cases that Cite This Headnote"

to focus on the terms of art or key words in a particular headnote. You can use this feature to find more cases with similar language and concepts.  ​

Ways to Use Citators

A citator is "a catalogued list of cases, statutes, and other legal sources showing the subsequent history and current precedential value of those sources.  Citators allow researchers to verify the authority of a precedent and to find additional sources relating to a given subject." Citator , Black's Law Dictionary (11th ed. 2019).

Each major legal database has its own citator.  The two most popular are Keycite on Westlaw and Shepard's on Lexis.

• Keycite Information Page
• Shepard's Information Page

Making Sure Your Case is Still Good Law

This video answers common questions about citators:

For step-by-step instructions on how to use Keycite and Shepard's see the following:

• Shepard's Video Tutorial
• Shepard's Handout
• Shepard's Editorial Phrase Dictionary
• KeyCite Video Tutorial
• KeyCite Handout
• KeyCite Editorial Phrase Dictionary

Using Citators For

Citators serve three purposes: (1) case validation, (2) better understanding, and (3) additional research.

Case Validation

Is my case or statute good law?

• Parallel citations
• Prior and subsequent history
• Negative treatment suggesting you should no longer cite to holding.

Better Understanding

Has the law in this area changed?

• Later cases on the same point of law
• Positive treatment, explaining or expanding the law.
• Negative Treatment, narrowing or distinguishing the law.

Track Research

Who is citing and writing about my case or statute?

• Secondary sources that discuss your case or statute.
• Cases in other jurisdictions that discuss your case or statute.

Knowing When to Start Writing

For more guidance on when to stop your research see:

• Terminating Research, by Christina L. Kunz

Automated Services

Automated services can check your work and ensure that you are not missing important resources. You can learn more about several automated brief check services.  However, these services are not a replacement for conducting your own diligent research .

• Automated Brief Check Instructional Video

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This guide is licensed under a Creative Commons Attribution-Noncommercial-Share Alike 3.0 United States License .

You may reproduce any part of it for noncommercial purposes as long as credit is included and it is shared in the same manner. 

• Last Updated: Sep 21, 2023 2:56 PM
• URL: https://guides.library.harvard.edu/law/researchstrategy

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Case Law Analysis: A Comprehensive Guide for Law Firms in Legal Research

The field of law is built upon a foundation of case law, where previous legal decisions serve as precedents for future rulings. For law firms engaged in legal research, the analysis and understanding of case law are crucial to providing effective representation for their clients. This comprehensive guide aims to equip law firms with the necessary tools and techniques to conduct thorough case law analysis.

Consider a hypothetical scenario: A client has been accused of copyright infringement in an online publication they authored. To mount a strong defense, the lawyers representing this client must delve into relevant case laws that have addressed similar issues in the past. By conducting a meticulous analysis of these cases, the attorneys can identify key arguments, potential defenses, and strategies that may be applicable to their client’s situation.

In this guide, we will explore various aspects of case law analysis, including how to effectively search for pertinent cases using online databases and legal resources. Additionally, we will discuss methods for critically analyzing court opinions and extracting essential information from them. Furthermore, we will examine different approaches to synthesizing multiple cases and creating persuasive legal arguments based on precedents set by previous courts. With these skills at hand, law firms can enhance their ability to provide accurate and informed advice to their clients while navigating complex legal landscapes.

By following By following the step-by-step instructions and utilizing the tips provided in this guide, law firms can develop a systematic approach to case law analysis. This will enable them to efficiently locate relevant cases, thoroughly analyze court opinions, extract key information, and synthesize multiple cases to build persuasive legal arguments. With these skills honed, law firms will be better equipped to provide effective representation for their clients and achieve favorable outcomes in their cases involving copyright infringement or any other legal matter.

Understanding Case Law

Case law is a crucial aspect of legal research and plays a pivotal role in shaping the decisions made by courts. By analyzing previous court cases, legal professionals gain insights into how judges have interpreted and applied laws in specific situations. This section will provide an overview of case law analysis, its importance in legal research, and the methods used to effectively comprehend and utilize it.

To illustrate the significance of case law analysis, let us consider a hypothetical scenario involving a dispute over copyright infringement between two software companies. Company A claims that Company B has copied their proprietary code without permission. To determine whether this claim holds merit, lawyers from both sides would delve into relevant case law precedents dealing with similar intellectual property disputes. By examining past rulings and the reasoning behind them, they can develop arguments based on established legal principles or identify any distinguishing factors unique to their case.

When conducting case law analysis, several key points should be considered:

• Precedent: Court decisions serve as binding precedents for future cases with similar facts or issues. Analyzing prior rulings allows lawyers to understand the application of laws in different contexts.
• Legal Principles: Case law often elucidates underlying legal principles that guide judicial decision-making. Identifying these principles aids lawyers in constructing persuasive arguments grounded in well-established norms.
• Judicial Reasoning: Examining the rationale employed by judges helps attorneys anticipate potential counterarguments or weaknesses in their own positions while highlighting strengths and weaknesses within existing jurisprudence.
• Evolving Interpretations: Over time, interpretations of laws may change due to societal developments or evolving perspectives. Monitoring changes in case law ensures attorneys remain current on applicable standards and trends.

To further illustrate these concepts visually, we present a table summarizing important aspects of case law analysis:

Understanding the significance of case law analysis is fundamental to effective legal research. By engaging with prior court decisions, legal professionals can navigate complex legal issues and develop informed arguments supported by established precedents and principles.

Importance of Case Law Analysis

Understanding Case Law: An Essential Component of Legal Research

In the previous section, we explored the concept of case law and its significance within the legal field. Now, let us delve deeper into why comprehending case law is crucial for effective legal analysis and decision-making.

Imagine a scenario where a defendant has been accused of copyright infringement in an online music-sharing platform. To build a strong defense strategy, it is essential for the defendant’s legal team to study relevant case law precedents that have addressed similar issues in the past. By examining these cases, they can gain valuable insights into how courts have interpreted copyright laws and applied them to comparable situations. This understanding allows them to anticipate potential arguments from the opposing counsel and prepare counter-arguments based on established legal principles.

To further emphasize the importance of case law analysis, consider the following key points:

• Precedential Value : Case law creates binding precedents that shape future interpretations of statutes and regulations.
• Legal Predictability : Analyzing case law enables lawyers to predict how courts are likely to rule on specific issues or disputes.
• Clarification of Ambiguities : Case law often helps resolve ambiguities or gaps present in legislation by providing guidance through judicial decisions.
• Evolutionary Nature : The body of case law evolves over time as society changes, ensuring that legal principles remain relevant and adaptable to contemporary circumstances.

To illustrate this topic visually, refer to the table below which highlights different aspects of case law analysis:

By studying case law diligently, attorneys can navigate complex legal terrain more effectively while offering their clients the best possible legal advice and representation. In the subsequent section, we will explore the essential steps involved in conducting a comprehensive case law analysis.

[Transition Sentence]: Now that we understand the significance of understanding case law, let us turn our attention to the step-by-step process of conducting thorough case law analysis.

Steps in Conducting Case Law Analysis

To effectively conduct legal research, law firms must undertake a comprehensive analysis of relevant case law. This section will explore the steps involved in conducting an in-depth case law analysis and highlight its significance in guiding legal strategies. Additionally, we will examine a hypothetical example that illustrates the practical application of this process.

The Process of Case Law Analysis:

Identification of Key Cases: The initial step in case law analysis is identifying key cases that are applicable to the legal issue at hand. By examining precedents set by higher courts or decisions made on similar matters, attorneys can gain valuable insights into the interpretation and application of relevant laws.

Reviewing Case Facts and Rationale: Once the key cases have been identified, it is crucial to thoroughly review their facts and underlying rationale. This involves analyzing how different aspects of the case contributed to the court’s decision-making process. Understanding these details helps lawyers assess which arguments were persuasive and ascertain how certain factors influenced judicial reasoning.

Evaluating Legal Principles Established: Another critical aspect of case law analysis is evaluating the legal principles established within each case studied. Lawyers need to determine whether these principles align with their client’s interests or if they conflict with their desired outcomes. Moreover, by assessing both supporting and dissenting opinions within a particular case, attorneys can anticipate potential counterarguments from opposing parties.

Example Hypothetical Scenario:

Consider a hypothetical scenario where a law firm specializes in employment discrimination cases. In one such matter, they are representing an employee who alleges gender-based pay disparity against her employer. To build a strong legal strategy, the firm engages in meticulous case law analysis involving prominent rulings related to equal pay rights for employees across various jurisdictions.

• Uncovering hidden biases
• Strengthening argumentation through precedent
• Ensuring fairness and justice prevail
• Empowering clients seeking redress

Table: Significant Cases in Gender Pay Disparity Litigation

By conducting a thorough case law analysis, attorneys can effectively identify relevant cases that will serve as building blocks for shaping their legal arguments. In the subsequent section, we will explore the process of identifying such relevant cases without repeating any steps already mentioned previously.

Identifying Relevant Cases

Section H2: Steps in Conducting Case Law Analysis

In the previous section, we explored the essential steps involved in conducting case law analysis. Now, let us delve deeper into the process of identifying relevant cases to ensure a comprehensive and effective legal research strategy.

To illustrate this step, consider a hypothetical scenario where a law firm is handling a personal injury case involving a slip and fall accident at a grocery store. The first task would be to identify relevant cases that have addressed similar issues or principles of law related to premises liability. By analyzing these cases, attorneys can gain insights into how courts have interpreted and applied the law in comparable situations.

When it comes to identifying relevant cases, there are several key strategies that can prove helpful:

• Keyword search: Begin by using specific keywords related to your legal issue when searching through databases or online resources. This will help filter out irrelevant cases and narrow down your results.
• Jurisdictional filters: Depending on your jurisdiction, apply appropriate filters such as state or federal court decisions to focus on precedents applicable within your desired scope.
• Citation tracing: Once you find an influential case on your topic, review its citations both before and after the decision date. This technique allows you to trace backward (precedential authority) and forward (subsequent interpretation) for additional relevant cases.
• Secondary sources: Consult secondary legal resources like academic articles, treatises, or practice guides that discuss similar legal concepts or areas of law related to your case.

By utilizing these strategies effectively, legal researchers can save time and effort while ensuring they unearth pertinent precedents crucial for their clients’ cases.

Table Example:

Understanding the significance of precedent is crucial for effective case law analysis.

Now that we have identified relevant cases, let’s explore the process of analyzing case precedents and its role in constructing persuasive legal arguments.

Analyzing Case Precedents

Analyzing case precedents is a crucial step in legal research as it allows law firms to extract valuable insights and establish persuasive arguments. Building upon the identification of relevant cases, this section dives deeper into the process of analyzing case precedents. To illustrate this process, let’s consider a hypothetical scenario involving a contract dispute between two parties.

When analyzing case precedents, one must begin by carefully examining the facts and issues involved in each case. For instance, in our hypothetical scenario, Party A claims that Party B breached their contractual obligations by failing to deliver goods within the agreed-upon timeframe. By reviewing similar cases where breach of contract was alleged, legal researchers can identify patterns and key elements that contributed to successful outcomes for plaintiffs or defendants.

To further facilitate understanding and engagement with this topic, here are some important considerations when analyzing case precedents:

• Legal Principles : Identify the legal principles established or applied in previous cases that are relevant to your own situation.
• Factual Distinctions : Determine if there are any factual distinctions between prior cases and your current matter that could impact how precedent should be interpreted.
• Judicial Reasoning : Carefully analyze the reasoning behind court decisions in order to comprehend how judges arrived at their conclusions.
• Counterarguments : Consider potential counterarguments based on conflicting decisions or alternative interpretations of existing precedents.

As part of an effective analysis process, organizing information through visual aids like tables can enhance comprehension. The following table demonstrates various aspects commonly examined during case precedent analysis:

By considering these factors and organizing information systematically, law firms can conduct a comprehensive analysis of case precedents to inform their legal strategies.

Transitioning into the subsequent section on applying case law analysis in legal practice, it is important to note that analyzing case precedents is just one step towards building strong arguments. By leveraging the insights gained from this rigorous process, lawyers can effectively apply relevant case law principles in real-world scenarios, thus enhancing their ability to advocate for their clients’ interests.

Applying Case Law Analysis in Legal Practice

Transitioning from the previous section on analyzing case precedents, we now turn our attention to the practical application of case law analysis in legal practice. To illustrate this process, let us consider a hypothetical scenario involving a dispute over intellectual property rights between two companies.

Imagine that Company A has developed a new technology and believes that Company B is infringing upon their patent. In order to build a strong legal argument, it becomes crucial for Company A’s legal team to effectively apply case law analysis. This involves examining relevant case precedents and using them as persuasive authorities to support their position.

In applying case law analysis in such situations, there are several key considerations:

Identification of Relevant Precedents:

• Thoroughly research and identify cases with similar factual circumstances or legal issues.
• Assess the jurisdictional relevance of each precedent based on its alignment with local laws and court decisions.
• Evaluate the persuasiveness of each precedent by considering factors such as the reputation of the court rendering the decision or any subsequent appellate rulings.

Dissecting Key Legal Principles:

• Analyze the reasoning behind each precedent’s decision-making process.
• Identify overarching legal principles established within these decisions.
• Understand how these principles can be applied or distinguished in relation to your client’s case.

Drawing Analogies and Creating Persuasive Arguments:

• Craft compelling arguments by drawing analogies between your client’s situation and relevant precedents.
• Highlight similarities in facts, legal issues, or underlying policy concerns.
• Emphasize why applying these precedents supports your client’s position ethically, legally, and commercially.

Anticipating Counterarguments:

• Consider potential counterarguments that opposing counsel may raise against your reliance on specific precedents.
• Develop strategic responses backed by additional supporting authorities or sound legal reasoning.

To further enhance your understanding of the practical application of case law analysis, refer to the following table which outlines a comparative analysis of select precedents relevant to our hypothetical intellectual property dispute:

By incorporating these key considerations and leveraging relevant precedents, legal professionals can effectively apply case law analysis in practice to build persuasive arguments for their clients’ cases.

Through this section, we have explored the process of applying case law analysis in legal practice by dissecting key principles, drawing analogies, anticipating counterarguments, and utilizing relevant precedents as persuasive authorities. By implementing such strategies thoughtfully and strategically, lawyers can enhance their ability to advocate successfully for their clients within the complex realm of case law.

Related posts:

• Legal Databases: Enhancing Law Firm Legal Research
• Legal Research in Law Firm: A Comprehensive Guide
• Legal Research Software: A Guide for Law Firms
• Legal Writing: A Guide to Effective Legal Research at Law Firms

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Legal analysis 101: A complete guide

• May 15, 2024

Jennifer Anderson

Ah, legal analysis. It’s the lifeblood of the profession and something, quite frankly, that those of us who went to law school take for granted. After all, legal analysis was drilled into our brains every day for three years straight.

This post, however, is intended for those valued non-JD colleagues of ours who are often called upon to assist with critical analyses. From legal assistants to paralegals, your firm will simply run better if everyone has a grasp on the fundamentals of legal analysis. 

This post begins with an explanation of FIRAC – the tried-and-true system for analyzing any legal issue. And, just for good measure, we’ll close with some basic principles on how to find, interpret, and understand the laws that impact your clients’ cases.

Understanding legal analysis

Simply put, legal analysis is the process of breaking down legal issues to understand their implications and reach a reasoned conclusion about the matter you’re working on.

It’s fundamental to the practice of law, particularly in civil litigation practices, where complex cases often require in-depth examination and interpretation of statutes and case law.

As we’ll discuss below, legal analysis involves multiple components. It starts with understanding the facts of your particular case and the issue that led your client to seek out legal counsel.

From there, it moves through the interpretation of relevant statutes and case law, and concludes with a logical application of legal principles to your facts. This step-by-step process helps you build strong arguments and anticipate opposing views.

So, how do you put it all together? Let’s dive in:

The framework: FIRAC

The FIRAC method is a common framework used in legal analysis. It stands for Facts, Issue, Rule, Application, and Conclusion. This method provides a structured approach to analyzing legal issues, making it easier to break down complex cases and derive meaningful conclusions. 

To illustrate how this method works, we’re going to use the example of a client who came to your firm after being injured when he tripped over a crack in the sidewalk of a city-owned park. He wants to know if he can sue the city and force it to pay for his injuries.

The first step in the FIRAC method is identifying the key facts of a case. Facts are the specific events, circumstances, or pieces of evidence that form the basis of the legal issue. 

When a client comes to you with a legal problem, they often want to tell you about their situation in excruciating detail. One of your first orders of business will be to sort out and review all relevant facts.

This may include your client’s own statements, as well as additional details from witnesses, documents, and physical evidence. This step requires careful attention to detail to ensure that no critical information is overlooked.

It also involves determining which facts aren’t relevant to your client’s case. 

In our example case, you’ll want to understand everything relating to your client’s fall. How deep was the crack in the sidewalk? Are there pictures of the crack? Were there signs warning of uneven pavement? Did anyone witness the fall? Has anyone else been injured by tripping over that particular crack? If so, when?

Irrelevant facts might include things like the color shirt your client was wearing at the time of the fall, what your client had for breakfast that day, or the fact that Mercury was in retrograde.

Once the facts are established, the next step is to identify the central legal issue(s) or question(s) that are going to impact your client’s outcome. This involves determining what legal principles or rules are at stake based on the facts.

Often, this step requires distilling complex information into a clear and concise legal question. The issue should be specific enough to guide further analysis but broad enough to encompass all relevant aspects of the case.

Turning back to our example, one issue will almost certainly be “was the crack in the sidewalk a ‘dangerous condition’ that the city needed to protect its citizens from?” 

Note here that cases often involve multiple issues. Although the same facts may impact various issues, you’ll want to address each issue separately. To keep things simple, we’ll only address one issue in our sample case.

In the rule step, you’ll need to identify the laws that govern the issue at hand. This may involve referencing statutory law, case law, or other legal doctrines. 

Understanding the rule is crucial because it provides the legal framework for analyzing the issue. The rules should be presented clearly, with appropriate citations and explanations, to ensure accuracy.

In our example case, both statutes and case law will supply the relevant rules. For example, California Government Code §830 gives us the definition of a “dangerous condition” on public property. The case of Fielder v. City of Glendale (among others) gives us a great framework for determining whether public sidewalk cracks are or are not dangerous as a matter of law.

Application

The application step is where the legal analysis truly comes to life. In this step, you’ll apply the identified rules to the facts of your client’s case. This involves examining how the rules govern the specific situation and what legal outcomes they suggest. 

The application step is often the most complex, as it requires drawing logical connections between the rules and the facts. This is also where legal reasoning plays a significant role. Remember, it’s your job to construct a persuasive argument based on the application of rules to facts.

Here’s what an analysis might look like in our example case:

Our client was injured when he fell over a ½ inch crack in the sidewalk while walking through City Park. 

Government Code §830 defines a “dangerous condition” as “a condition of property that creates a substantial (as distinguished from a minor, trivial or insignificant) risk of injury when such property … is used with due care in a manner in which it is reasonably foreseeable that it will be used.” 

In the case of Fielder v. City of Glendale , the court determined that a three-quarter-inch depression in the sidewalk that caused the plaintiff to fall was not dangerous as a matter of law.

Our client fell while using the sidewalk in the manner for which it was intended – taking a casual walk. Given that the crack our client tripped over was smaller than that at issue in Fielder, it is unlikely that a court would find the crack to be a “dangerous condition” under California law.

Obviously, this is a terribly simplified analysis, but hopefully, you get the picture.

FIRAC conclusion

The final step in the FIRAC method is the conclusion. Here, you’ll summarize your analysis and provide a clear answer to the legal issue. The conclusion should be concise, addressing the key points of the analysis and presenting a logical outcome.

It’s important to ensure that the conclusion is supported by the previous steps and that it aligns with established legal principles.

Brevity is the key here. Often, the partner who assigned the analysis will turn right to your conclusion section to get an overview of the situation prior to talking to your client. This is where she wants a quick answer – not another full analysis.

Returning to our example, the conclusion might read something like this: “Based on current statutes and prevailing California case law, it is unlikely that the crack our client tripped over in City Park would be considered a ‘dangerous condition’ that the city needed to protect its citizens from.”

So, there you have it – legal analysis in a nutshell. Before we let you go, however, let’s talk about some of the common issues that arise when you’re looking for the rules that will govern your case.

Finding and interpreting rules

For beginners, finding and interpreting the rules that apply to a given case can be a bit daunting. Here are some tips that will keep you on the right path:

To effectively interpret statutes, follow a systematic approach . Start by reading the statute thoroughly to understand its literal meaning. If the meaning isn’t clear, look for other sources like case law, legislative history, or even expert commentary for additional context.

When it comes to case law, also known as judicial precedent , you’ll be using previous court decisions as authoritative guidance for determining how courts in your jurisdiction might resolve your client’s case.

In our legal system, courts generally follow the principle of “ stare decisis ,” which means that they tend to respect previous decisions and use them as a basis for resolving current cases. This principle helps maintain consistency and predictability in the legal system.

That said, some prior cases are simply better for your client’s case than others. Here’s what you want to look for:

• Jurisdiction: Case law from the same jurisdiction as the current case is typically more useful.
• Court Hierarchy: Higher court decisions generally carry more weight than lower court decisions.
• Similarity of Facts: Cases with similar facts are more likely to be relevant to the current case.
• Legal Issues: Identifying cases with comparable legal issues helps to understand how courts may rule in your matter.

Additionally – and I can’t stress this enough – you have to stay updated on recent legal developments and court decisions that might impact your client’s case. If there’s a statute or case that is particularly useful, you want to follow it closely. Set up a Google Alert or some similar mechanism that will keep you updated.

Legal analysis, as discussed through the FIRAC method, is crucial not only for lawyers but for all legal professionals who contribute to a case.

Understanding the fundamental aspects of FIRAC—Facts, Issue, Rule, Application, and Conclusion—empowers legal teams to dissect complex legal scenarios effectively, ensuring that all relevant details are considered and applied correctly

I hope this guide has underscored the importance of each component in the legal analytical process and offered you some practical, actionable insights.  So, there you have it. Whether you’re enjoying your first week in your new law firm or simply brushing up on your analytical skills, we hope this guide helps you help your clients.

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Case Study Analysis

Toolkit for Legal Interpreters

• Skill Development
• Activity: Case Study Analysis

Legal Interpreting Skill Development:

This activity guide enhances legal interpreting skills by exploring an aspect of the legal system and the work of interpreters through the analysis of a real-life legal situation. It provides a structure for analyzing case studies. Cases for analysis can be found in Trial Transcripts .

What is Case Study Analysis?

For the purpose of the Toolkit for Legal Interpreters, CASE STUDIES are documented specific real-life legal situation/scenario - such as a transcript of an actual trial - used as a teaching tool in helping interpreters gain a deeper understanding of some aspect of the legal system and their work as interpreters within that system.

A case study that involves a transcript of an actual trial can also help interpreters gain a deeper understanding of the law and its application to specific legal issues, as well as an appreciation for legal procedure and processes. If the CASE STUDY involves an ethical dilemma that legal interpreters might confront, then the process of analysis enables interpreters to gain a greater understanding of how to apply ethical standards and practices to interpreting in the legal system.

The process of analysis requires interpreters to identify key elements of the case and to discuss the implications for interpreting and/or possible actions an interpreter must take as part of their interpretation process, and requires that they support their findings by the line of reasoning employed and assumptions made.

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Preparing a Case Study Analysis

Select one of the trial transcripts from the Toolkit to analyze.

Many of the cases are not specific to Deaf individuals, but rather focus on an issue of law that is important for interpreters to understand. As an alternative, you can do an internet search for a trial of your interest to use for the purpose of analysis.

For example, here are the transcripts for both the criminal and civil trial of  O.J. Simpson . As well, there are a selection of trial transcripts available through the John Jay College of Criminal Justice's Lloyd Sealy Library .

Read through the transcript.

As you read through the transcript, take notes, highlight relevant facts, and underline legal terminology. Where in doubt, look up the meaning of the legal terms and consider the application of the meaning to the particular case you are analyzing. This will expand your understanding of the case.

Prepare an Executive Summary.

This is a synopsis of the trial generated in either written English or ASL (taped). Create an accurate and concise description of the trial/case OR the portion of a trial or case you are reviewing.

What is the citation of the trial; what is the legal issue(s) being tried; what are the compelling facts related to the issue; what is the central position of each side of the issue (the position of the plaintiff/prosecutor and the position of the defendant) and what are the key points to their argument; what is the outcome of the trial?

Also provide a list of the primary “players” - the names and gender of the attorneys, plaintiffs, defendants, judge, witnesses, etc. If expert witnesses were used, identify their area of expertise and which side of the case called them. Provide a brief summary of what the focus of their expert testimony was and what it contributed to the matter before the court.

NOTE:  These are two samples of a citation of a case.  

• United States of America, Plaintiff v. James Graystone and Phillip Myers, Defendants Criminal Case #2016-10327-GOA
• Marcia Smith Polinski, Plaintiff v. Harold Richard Polinski, Defendant Civil Case #98-20334

Discuss the Case from the Perspective of an Interpreter.

The case you are studying may or may not have Deaf individuals involved. However, for the purpose of the analysis, discuss the implications of the case from the perspective of an interpreter - assuming there are Deaf individuals involved in some capacity as a witness, victim/plaintiff, defendant, or juror. Answer the following questions. These questions can be answered in written English or ASL (taped).

What are the primary factors to consider when staffing this case with an interpreting team? How would the factors differ if the Deaf individual(s) involved was/were the plaintiff, the defendant, a witness, an expert witness, juror or interested person observing the trial.

Assuming the role of the proceedings interpreter, what are the primary issues and/or challenges to consider and what would you need to do to prepare for in interpreting this particular case? Prove each issue or challenge you have identified is genuinely a concern by providing supporting evidence you have discovered in the case study and by discussing theory and/or what you have learned from your course content.

What tools and/or resources would you require to assist you in your work as a proceedings interpreter? What is the rationale/reasoning for using the specific tools and resources you identified?

What cultural, linguistic, or racial issues surfaced or might surface in this particular case? What is the implication of these issues for the interpreter, the consumers, the jury?

What matters of law or questions of legal and/or interpreting procedure do you have as a result of studying this case? How can you go about finding the information you seek? Select two of the legal or procedural questions you identified and do the research/outreach necessary to find the answers and provide a summary of your findings.

Cite the references and/or expert informants you relied upon in formulating your responses to these questions.

Summarize Your Observations.

As with the other sections, you can convey your summary in written English or ASL (taped). In the summary, reflect on the analysis process and respond to the following questions:

What is your reaction to the case as a whole? How does the case and the outcome impact you as an individual - separate from your work as an interpreter? Are there experiences you have had in your life that give you a particular observation or reaction to this case? How might these observations and reactions impact your work as an interpreter? As you leave this case, what impressions do you have about the legal system, the outcome of the case, and the work of interpreters within the legal system?

What new information about the law, legal system and/or interpreting did you learn as a result of analyzing this case? How do you see yourself applying this information as an individual and interpreter practitioner? 

What questions still remain for you as a result of this case analysis? How can you go about finding the answers to these questions?

Group Analysis

The following six group exercises could be done with small groups or one individual student working with another individual student.

• A group of students (3-4) can be assigned this task and divide up the elements of the analysis and then work together to discuss their findings and create the final analysis to submit to the mentor. 
• Multiple groups of students can analyze the same case and then engage in a facilitated discussion to identify their similarities and differences. Everyone’s understanding of the case will be expanded by listening to the perspectives and findings of other students about the same case.
• One small group of students can present their case analysis to another small group of students who analyzed a different case and they can each discuss their observations and questions. Each group of students presents its case analysis to the other group for feedback and discussion.
• Students can argue one perspective on the case, almost in a debate format - the plaintiff/prosecutor or the defendant’s perspective - offering facts and evidence drawn from the case analysis. Ideally, students will have the opportunity to argue a perspective that is different from their own some of the time so that they can strengthen their understanding of legal principles and strategy. 
• Students can exchange their final case analysis with one another and provide feedback to each other. In providing feedback, students will consider the following.
• What were the parts of the analysis you felt were the strongest and most impactful and why?
• What were the parts of the analysis you felt were the weakest and least impactful and why?
• What new insight did you, as the reviewer, take away from the analysis?

A PDF version of this guide is available - Case Study Analysis

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The legal determinants of health: harnessing the power of law for global health and sustainable development

Lawrence o gostin.

a O'Neill Institute for National and Global Health Law, Georgetown University Law Center, Washington, DC, USA

John T Monahan

b Office of the President, Georgetown University, Washington, DC, USA

Jenny Kaldor

d School of Law, University of Tasmania, Hobart, TAS, Australia

Mary DeBartolo

r Northwestern Memorial Healthcare, Chicago, IL, USA

Eric A Friedman

Katie gottschalk, susan c kim.

c Center for Global Health Practice and Impact, Georgetown University, Washington, DC, USA

e Health and Environment, Government of Iraq, Baghdad, Iraq

Agnes Binagwaho

f University of Global Health Equity, Kigali, Rwanda

Gian Luca Burci

g Global Health Centre, Graduate Institute of International and Development Studies, Geneva, Switzerland

Luisa Cabal

h UNAIDS, Geneva, Switzerland

Katherine DeLand

i DeLand Associates LLC, Geneva, Switzerland

Timothy Grant Evans

j Health, Nutrition and Population Global Practice, World Bank Group, Washington, DC, USA

Eric Goosby

k School of Medicine, University of California San Francisco, San Francisco, CA, USA

Sara Hossain

l Supreme Court of Bangladesh, Dhaka, Bangladesh

n Harvard T H Chan School of Public Health, Boston, MA, USA

o Global Health and Development, London School of Hygiene & Tropical Medicine, London, UK

Mirta Roses Periago

p National Academy of Sciences of Buenos Aires, Buenos Aires, Argentina

Rodrigo Uprimny

q Dejusticia, Bogota, Colombia

Alicia Ely Yamin

m Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard Law School, Cambridge, MA, USA

Associated Data

Executive summary.

Health risks in the 21st century are beyond the control of any government in any country. In an era of globalisation, promoting public health and equity requires cooperation and coordination both within and among states. Law can be a powerful tool for advancing global health, yet it remains substantially underutilised and poorly understood. Working in partnership, public health lawyers and health professionals can become champions for evidence-based laws to ensure the public's health and safety.

This Lancet Commission articulates the crucial role of law in achieving global health with justice, through legal instruments, legal capacities, and institutional reforms, as well as a firm commitment to the rule of law. The Commission's aim is to enhance the global health community's understanding of law, regulation, and the rule of law as effective tools to advance population health and equity.

The term law throughout is used to mean legal instruments such as statutes, treaties, and regulations that express public policy, as well as the public institutions (eg, courts, legislatures, and agencies) responsible for creating, implementing, and interpreting the law. By establishing the rules and frameworks that shape social and economic interactions, laws exert a powerful force on all the social determinants of health. Well designed laws can help build strong health systems, ensure safe and nutritious foods, evaluate and approve safe and effective drugs and vaccines, create healthier and safer workplaces, and improve the built and natural environments. However, laws that are poorly designed, implemented, or enforced can harm marginalised populations and entrench stigma and discrimination.

This Commission brings together global leaders in the fields of health, law, and governance. We make the case for better, more strategic linkages between health and law, and the professionals who work in both fields. We begin by providing a short explanation of legal terms and concepts, and the actors and institutions that govern health. Our report is structured around four legal determinants of health, each of which powerfully affects health outcomes. We use the term legal determinants of health because it demonstrates the power of law to address the underlying social and economic causes of injury and disease. These four legal determinants show how law can substantially influence health and equity. We do not endeavour a systematic review of law in global health, but rather to advocate for, and demonstrate, the crucial value of law in advancing global health with justice. Finally, drawing on identified areas for reform, as well as principles of good governance and the right to health, we offer seven concrete recommendations for action.

Legal determinant 1 states that law can translate vision into action on sustainable development. The UN Sustainable Development Goals (SDGs) present a bold and unifying vision for global health and development. Law offers the mechanisms, frameworks, and accountability measures to achieve this vision. In particular, law can be used to lay the foundations for Universal Health Coverage (UHC), which is a crucial element of sustainable development. We show how the power of law can be used to achieve health with justice through a case study of how law can build and implement UHC. We make two recommendations for action.

Recommendation 1 suggests that the UN, WHO, and international partners should set standards to support the implementation of, and objectively evaluate compliance with SDG 3·8 (UHC), as well as the upcoming UN political declaration on UHC in 2019.

Key messages

• 1 Law affects global health in multiple ways, by structuring, perpetuating, and mediating the social determinants of health.
• 2 Although law has been central to major public health achievements in the past, its capacity to advance global health with justice remains substantially underutilised, particularly among professionals in the fields of health and science.
• 3 The right to health, a legally binding norm, provides a foundation for advancing global health with justice and should underpin health-related legal reforms.
• 4 Every human being has a right to affordable, high quality health services. By embedding equity and accountability in all health systems, the law and the rule of law can achieve health coverage that is truly universal—delivering the Sustainable Development Goals' promise to leave no one behind.
• 5 Although the ability to enforce compliance with international legal obligations is generally limited, and largely dependent on power dynamics and political will, creative mechanisms can foster compliance and help establish impetus for action.
• 6 Law can address the pressing health concerns of the 21st century, across diverse areas. From tobacco control, non-communicable diseases, and road safety, to health emergencies, law can implement fair, evidence-based interventions to save lives. The global health community should champion evidence-based legal interventions and build the research case for legal action.
• 7 Laws that stigmatise or discriminate against marginalised populations are especially harmful and exacerbate health disparities. The global health community must oppose laws that undermine the right to health and to equity.
• 8 To realise the full potential of law to advance global health with justice, the global health community should build legal capacity and establish a sustained dialogue with legislators, regulators, judges, civil society, and researchers.

Recommendation 2 advises that governments should strengthen or create a legal framework, such as a constitutional or statutory right to health, to ensure rights-based UHC on the basis of principles of equity and non-discrimination, including affordability, financial protection, transparency, accountability, participation, privacy, and sustainable financing.

Legal determinant 2 states that law can strengthen the governance of national and global health institutions. Law can be used to structure and clarify the complex web of institutions, norms, and processes that govern global health. We identify three key governance challenges that undermine coordinated action for health, as well as ways in which law can ensure good governance for health. First, where the mandates of global health actors overlap, conflict, or leave gaps, law can harmonise mandates and provide mechanisms to promote cooperation. Second, innovative legal and governance strategies can foster state compliance and strengthen existing international rules. Third, law can increase transparency, openness, inclusiveness, and accountability. We make two recommendations for action.

Recommendation 3 suggests that the UN, WHO, and international partners should use their respective powers and influence to safeguard the public's health and safety through the creation or adoption of good governance standards, embracing the highest principles of equity, inclusive participation, transparency, and accountability.

Recommendation 4 advises that governments should develop legal frameworks that establish principles of good governance throughout national health systems and policy making, form a country-appropriate mechanism to advise on legal interventions with high health impact, and adopt legislation requiring health impact assessments for policies, programmes, and projects that might seriously affect health.

Legal determinant 3 states that law can implement fair, evidence-based health interventions. Evidence-based laws, effectively implemented and fairly enforced, can create the conditions for good health. We provide a framework for evaluating health laws and identifying those laws that advance health with justice. We offer concrete examples of such laws, across three domains of health: infectious diseases, non-communicable diseases, and injuries. In each domain, we discuss the ways in which international and domestic laws interrelate and inform one another. We also show how laws that are not informed by evidence and human rights could instead undermine health and justice, entrenching inequality and discrimination. We make one recommendation for action.

Recommendation 5 suggests that WHO should increase its legal capacity to enable it to spearhead development of a global evidence-base for public health laws and to support the enactment and implementation of national and global health laws that are effective and sustainable.

Legal determinant 4 emphasises the importance of building legal capacities for health. Strong legal capacities are a key determinant of progress towards global health and sustainable development. Yet, too often, countries lack either the basic legal infrastructure or the capacity to build it. We make the case for productive, mutually reinforcing linkages between law and health, and identify three aspects of legal capacity-building for health: improving legal environments, growing the evidence-base with high quality effectiveness research, and training key actors in law-making and law-implementing skills. We make two recommendations for action.

Recommendation 6 suggests that governments should build national capacities to enact and effectively implement public health laws.

Recommendation 7 suggests that WHO and The Lancet should partner with legal and health experts to create an independent standing commission on global health and the law that would advance the health-related SDGs by proposing evidence-based legal interventions for addressing major global health challenges, reforms of the global health architecture and international law, and strategies to build and strengthen global and national health law capacities.

In making these recommendations, we acknowledge that law reform is a complex and drawn-out process, presenting both technical and political challenges. Achieving global health with justice will require international and interdisciplinary cooperation, as well as leadership at all levels. However, as we underline in this report, law reform holds enormous promise. With the ability to effect real change at the population level, we argue, law should be considered among the key tools of the global health community. By providing insight on the legal determinants of health, our aim is to empower the global health community to strengthen its legal capacity, and to use law more strategically in the pursuit of health and equity. Globalisation has heightened risks to our health, but it also presents unprecedented opportunities to confront global health threats collaboratively, drawing on expertise and lessons learned within and among nation states. No government acting alone can achieve health with justice. Instead, we need laws and policies at every level—local, national, and global—to achieve a world that is healthier and safer.

Introduction

Health with justice.

Health in the 21st century is being shaped by rapid globalisation. The unprecedented movement of people, money, technology, and ideas around the world is changing the profile of health and disease. Although previous decades have seen substantial reductions in major global risk factors such as unsafe sanitation, and malnutrition, new threats have emerged. 1 Global health hazards nowadays share four important features: (i) health hazards are not bound by borders, ranging from infectious diseases, to non-communicable diseases, and injuries; (ii) they have common underlying causes, such as dangerous pathogens, unhealthy behaviours, or unsafe environments; (iii) they are exacerbated by inequities linked to the socio-economic determinants of health; and (iv) they require a coordinated, multi-sectoral global response. 2 , 3 , 4 A crucial element of that response will be the strategic use of law at all levels—local, national, and international—resting on stronger cooperation between the legal and health professions. Just as the interdependence of states and people heightens health risks, it also presents unprecedented opportunities to confront global health threats collaboratively, drawing on expertise and lessons learned within and among nation states.

The mission of the Lancet -O'Neill Institute of Georgetown University Commission on Global Health and Law (the Commission) is to articulate a compelling vision of the role of law in global health. In this report, we explain key legal concepts, offering important ways in which law can be wielded to advance health and equity—not for an audience of legal scholars, but for the global health community. Although many global health professionals will be familiar with legal measures as an emergency response to health crises, this is only one facet of law. 5 Less well understood is the role of law in governing global health institutions, in resolving disputes, and in health promotion and protection. Even less visible are those uses of law that, while not necessarily designed to affect health, have a profound impact upon it. Understanding these forces, and how to harness them, will be vital to improving population health in the 21st century.

Law and global health

We define global health as: study, research, and practice with the objective of preventing injuries and diseases and promoting the public's health, while achieving equity in health for all people worldwide—both within and among states. 6 In adopting this definition, our report builds on the 2014 Lancet -University of Oslo Commission on Global Governance for Health ( Lancet -Oslo Commission), which concluded that “we must no longer regard health only as a technical, biomedical issue, but acknowledge the need for global cross-sectoral action and justice in our efforts to address health inequality.” 4 Global health is infused by the value of social justice, aiming to address gaping health disparities within and among countries. 7 It strives to realise the universal right to health, grounded in international human rights. 8

Law is a key determinant of health. By law, we mean the statutes, regulations, and rules that express public policy. We also include the public institutions such as legislatures, agencies, and courts in our definition, which are responsible for creating, implementing, and interpreting the law. 9 Law exerts a powerful influence on health by structuring, perpetuating, and mediating the risk factors and underlying conditions known as the social determinants of health: 10 education, food, housing, income, employment, sanitation, and health care. The impact of law is felt not only in individual decisions (eg, of courts and tribunals) but also in statutes and regulations that operate at the population level (eg, agricultural subsidies, Universal Health Coverage [UHC], or mandatory seatbelt usage). As such, law can be a powerful tool for securing and advancing health and equity. It can be used to set and defend the norms and standards of good health, to establish and strengthen resilient health systems, and to hold actors and institutions accountable.

However, law can also be a formidable barrier to achieving global health and equity. Throughout history, misguided, out-dated, arbitrary, or discriminatory laws have caused great harm. Punitive laws, for example, can discourage marginalised individuals from accessing care, restrict reproductive rights, and enable discrimination in employment or insurance. Whether driven by animus or unsupported by scientific evidence, bad laws can undermine individual and population health, while entrenching inequalities. They can exclude, stigmatise, and inappropriately punish individuals. Furthermore, they can constrict the space for dissent and debate, for an independent press, and for social action. In such cases, law reform is crucial—but often difficult. The process of overturning old national legislation or adopting revised or new treaties often involves bitter and drawn-out struggles. New or better health laws can threaten the interests of powerful actors, including states, businesses, and lobbyists, who will vigorously oppose reform. Even if law reform is possible, once in force, new laws face challenges of monitoring and enforcement, in arenas often characterised by fragmentation and contestation.

Approach and aims

The Commission views law and health as mutually reinforcing, and urges the legal and health communities to work cooperatively toward a common goal of “global health with justice”. 8 Working together, law reform should afford people “a fair and just opportunity to be as healthy as possible”. 11 Law reform should also seek to eliminate the “systematic and potentially remediable differences in one or more aspects of health across socially, demographically, or geographically defined populations or population subgroups,” 12 as well as inequalities or differences in health that are “avoidable, unfair or [which stem] from some form of injustice”. 13 This vision is expressed in the United Nations Sustainable Development Goals (SDGs), which view health as a key component of a comprehensive, universal development agenda. The SDGs envision “justice for all”, resting on “transparent, effective, and accountable institutions”. 14

The multiple actors, institutions, and sectors in global health offer great promise to achieve health with justice, but also face steep challenges. Governments and international institutions do not harness the full power of law to improve health and save lives—whether by dismantling barriers or by enacting affirmative reforms to safeguard population health. Therefore, ensuring that the global health community clearly understands the role of the law, and how best to use it, is imperative. This report makes the case for the power of law to improve health, by informing the global health community about the effects of law on health (through what we describe as the legal determinants of health); exploring real-world case studies, opportunities and challenges; linking the health and legal communities, while building shared capacity (ie, infrastructure and resources); and empowering communities, countries, and global health institutions to use law to advance global health with justice. 9

The Commission assembled a multidisciplinary team of experts from diverse backgrounds, including law, health, policy, economics, and governance. While reflecting this richness of expertise, our Report sits within the disciplinary tradition of public health law scholarship, 15 and the emerging field of global health law scholarship. 7 Public health law is “the study of the legal powers and duties of the state to ensure the conditions for people to be healthy … and the limitations on the power of the state to constrain the…legally protected interests of individuals for the common good.” 15 Global health law, as a related field of study, uses a similar analytical orientation, but focuses on the relationship between international law and health.

Law is the primary topic of analysis in our report. Public health law predominantly uses legal doctrinal methods, informed by analytical frameworks from epidemiology and population health. Public health law is beginning to incorporate empirical methods, designed to evaluate the effects of law on public health, 16 and has a strong normative dimension: the view presented in this Commission is that not only is law a powerful tool for achieving global health with justice, but also that law should be used for this purpose. The universal right to health is a core standard against which legal interventions should be assessed.

As the Lancet -Oslo Commission powerfully emphasises, issues far removed from the traditional public health context—for example, market forces, income inequality, and global governance structures—have a substantial effect on health. Law stands to influence almost every one of these, meaning that the subject of global health and the law is potentially vast. Therefore, the Commission has had to be selective, and, for this reason, is necessarily limited in scope. Our concept of legal determinants is not the only way to frame the topic. Rather, it reflects the Commission's views of what constitute the major dimensions of law in global health, in the present era. The Commission has identified areas of law that most directly affect population health, and which lie within the remit of public health authorities. We do not purport to offer a systematic review, but rather to enunciate core legal concepts, building the case for the value of law in global health.

The legal determinants of health

Our Report begins with a short explanation of relevant legal terms and concepts: discussing where and how law works locally, nationally, and internationally, and why the rule of law is essential for health, development, and justice. We also describe the main actors in global health. This provides a foundation for our four key legal determinants of health: the areas identified in which stronger, more strategic linkages between health and law could substantially strengthen the overall global health agenda.

The first legal determinant is that law can translate vision into action regarding sustainable development. Law can help to achieve the SDGs' unifying vision for global health and development. We illustrate the potential of law in advancing the SDGs through a case study on UHC. The second legal determinant is that law can strengthen the governance of national and global health institutions. The field of global health is complex, comprising a web of institutions, norms, and processes at the global, national, and subnational levels. Weak governance undermines leadership and coordinated action for health. Law can strengthen health governance, including transparency, benchmarks, and monitoring, with ongoing evaluation, civil society engagement, and accountability. The third legal determinant is that law can implement fair, evidence-based health interventions. Evidence-based public health laws—effectively implemented and enforced—can create the conditions for healthy populations. We offer key examples of effective laws across three health domains: infectious diseases, non-communicable diseases, and injuries. We also show how law can undermine health and justice. The final legal determinant is that law can be used to build legal capacities and reinforce all the legal determinants of health. All the aforementioned determinants require stronger, mutually reinforcing linkages between law and health. Effective health laws are guided by science and translate the best available evidence on health improvement. Legal capacity building includes stronger legal institutions (legislatures, agencies, and courts), expanding the evidence-base with research evaluating the effectiveness of laws, and training key actors in law -making and law-implementing skills.

In section 6, we offer seven recommendations, drawing on the major concepts identified throughout the report. The recommendations encompass these four legal determinants of health, covering rights-based UHC, good governance standards, fair and evidence-based interventions, and building legal capacity.

Section 1: the legal system for global health

The concept of law has long been debated among legal scholars, as have modes of interpretation. For the purposes of this report, the Commission proposes a “Primer on Law” intended to be understandable to a public health audience. In this section, we define law and explain how it is created, implemented, and enforced at the domestic and international levels; describe the essential idea of the “rule of law”; articulate the obligations of the state to ensure the conditions for health; and explain how law functions as a tool to shape health outcomes. Finally, we identify the key actors and institutions in global health.

What is law? How is it created, implemented, and enforced?

Although not always perceptible, law is all around us. The most common definition of law is a body of norms (or rules of conduct) of binding force and effect, specified and enforced by a recognised authority. Law is used to create rights and duties, which should be applied fairly and consistently throughout society. Once implemented, people experience the effects of law every day, as it shapes their lives through the enforcement of legal standards and accompanying policies. This understanding of law is best illustrated at the domestic level, where the recognised authority is the sovereign state—the supreme authority within that territory. Because nation states have sovereign authority, they can enact and enforce laws. However, no sovereign authority exists at the international level, and the law requires states to agree to the terms of the legal instrument. Even when governments do assent to international agreements, these can be hard to enforce. Nevertheless, international legal norms remain essential for advancing health rights.

Domestic and international law are interrelated and bi-directional in their impact on health and justice. Innovations in domestic law and policy can offer a model for other cities, countries, or regions to follow, or have a global effect; high-impact litigation in one jurisdiction can empower advocates in other jurisdictions to undertake similar action. International law, in turn, influences domestic law and policy by creating widely accepted standards. Domestic legal norms diffuse to other jurisdictions and up to international institutions, while international norms diffuse down to influence local and national laws, regulations, and policies.

Domestic law

Law is used to establish norms, rules, and systems. In the health context, these rules should seek to reduce or prevent risks of injury and disease equitably across populations. 17 In addition to imposing obligations on individuals and businesses in a society, law also confers rights; for example, in many countries, every inhabitant has the right to health care and public health services, and to equal justice under the law. The state holds the primary obligation to fulfil these entitlements. Domestic law encompasses the following sectors, each derived from different sources. Constitutions are the highest law of the land. Statutes, regulations, and case law must conform to constitutional norms and principles. Statutes (also called legislation, acts, laws) enacted by legislatures such as Parliament or the Congress express public policy. Regulations, also termed delegated legislation, from executive or administrative agencies safeguard the public's health and safety (legislative bodies typically empower agencies to act). Case law, from courts and other tribunals, interprets and applies the constitution, statutes, and regulations to specific cases and sets judicial precedent. Beyond individual cases, the effect of case law differs from country to country, depending on its constitutional and legal traditions.

Constitutional law is widely regarded as the supreme law of the land. For the other three sources of law, different jurisdictions might accord them different importance or priority. We use the term “law” to encompass all four sources—each of which can substantially affect health—as well as their interactions.

International law

International law does not take the same form as domestic law. The simplest definition of international law is a set of norms or rules generally regarded and accepted as binding, in relations between states and other groups such as international organisations. International law primarily governs the conduct of states but can also substantially affect private parties such as corporations (eg, in relation to trade law) and individuals (eg, in relation to human rights law). Article 38 of the Statute of the International Court of Justice offers the most authoritative statement of the sources of international law, listing three primary sources: treaties, customary international law, and general principles. 18 ( panel 1 ).

Sources of international law: treaties, custom, and general principles

Treaties are international agreements (which might also be referred to as conventions or covenants), concluded between states in written form, and governed by international law. However, States must give their consent to be bound—and even if they do so, they might express reservations to exclude or to modify their legal obligations. A country that has ratified or acceded to a particular treaty, and is therefore legally bound by its provisions, is described as a state party. Certain international institutions have law-making power. WHO has adopted two major treaties under its Constitution: the Framework Convention on Tobacco Control (adopted under Article 19) and the International Health Regulations treaty (adopted under Article 21). 18

Customary international law refers to legal norms that have emerged from general and consistent state practice. Customary law is binding on all states, except those that persistently object.

General principles of law refer to an amorphous body of law that emphasises broad principles recognised in national legal systems such as common law, civil law, or Islamic law (Sharia). Given the proliferation of treaty law, modern tribunals rely less on general principles and consider them to be a secondary source of law.

Unlike in domestic law, there is no distinct international sovereign authority, and no global government steers international relations and transnational cooperation. Instead, various international institutions such as the UN, WHO, and the World Trade Organization (WTO) have law-making powers or act as forums to facilitate negotiation of treaties by member states. Additionally, states themselves might negotiate bilateral or multilateral treaties or other transnational agreements.

Trade is an example within which various forms of international law are evident. The WTO oversees several multilateral treaties, to which its member states adhere. States are also free to negotiate their own trade agreements (FTAs), such as regional compacts (eg, the United States–Mexico–Canada Agreement) or bilateral agreements, which might create additional norms to those found in WTO treaties. Even though these agreements are usually outside the sphere of the WTO, they must be consistent with WTO rules.

In the absence of a sovereign authority and a clear hierarchy of norms and rules, international law faces multiple governance challenges, including ensuring efficient implementation and compliance (see section 3). For example, international human rights are a central goal of many global health organisations and an important commitment for countries. However, states' compliance with human rights has been highly variable, often undermined by powerful political and economic interests.

Across sectors, contemporary governance is characterised by the increasing use of non-binding instruments adopted with a normative intent. These instruments aim to guide, urge, or discourage particular behaviours. Soft legal instruments, covering a broad range of topics, are known by various terms, 19 and we have chosen to use the term soft rules throughout this report.

The broad category of soft rules includes “any written international instrument, other than a treaty, containing non-binding principles, norms, standards, or other statements of expected behaviour.” 20 Codes of practice, global strategies, declarations and resolutions can all be described as soft rules, as can recommendations, guidelines, and frameworks. UN and WHO resolutions, although agreed through a formal legal process, usually do not create binding legal obligations for member states. However, although not legally binding, these instruments can have practical effects comparable to those of binding law, and are especially important to benchmarking, monitoring, and transparency.

Soft rules have several advantages over formal law. They are usually less costly (in both economic and political terms) and quicker to negotiate; they can be less rigid, and therefore easier to amend; and they can reflect more ambitious targets. Governments are often more willing to sign up to goals that are framed as targets or declarations rather than obligations. 21 Furthermore, processes to develop soft rules can include a more diverse coalition of actors beyond nation states, including voices from civil society that are traditionally marginalised in treaty negotiations. 22

The relationship between soft rules and hard law is fluid. Soft rules can form a basis for the development of formal international law, or international governments could adopt non-binding standards into their legal instruments. For example, WTO's Agreement on Sanitary and Phytosanitary Measures incorporates the non-binding guidelines of the Codex Alimentarius Commission—a collection of internationally recognised standards, codes of practice, and guidelines that apply throughout the food supply chain. 23 The United Nations Political Declaration on the Prevention and Control of Noncommunicable Diseases (September 2011) offers another example of soft rules. Negotiated through the General Assembly, the Declaration contains member states' commitments to prevent and control non-communicable diseases.

Perhaps most importantly, soft rules can be adopted into domestic law through a nationally sanctioned process (eg, through legislative or judicial decrees). Many soft rules aim for national-level implementation, including the Joint United Nations Programme on HIV and AIDS (UNAIDS) guidance on the prevention and treatment of HIV, and WHO's guidelines on salt and sugar consumption. Countries have discretion to select which soft rules to adopt domestically. Figure 1 shows the relationship between international and domestic law, including the translation of soft rules into domestic law.

Relationship between domestic and international law

The rule of law

To earn and maintain the trust of the public, law makers—including legislatures, administrative agencies, courts, and international bodies—must create, enforce, and interpret the law impartially. These actions are the fundamental precept of the rule of law. Under the rule of law, no individual, business, institution, or government official is above the law: governments and public officials must be held legally accountable to act in the public interest ( panel 2 ).

We adopt the definition used by the UN in its 2004 report, The Rule of Law and Transitional Justice in Conflict and Post-Conflict Societies:

“A principle of governance in which all persons, institutions and entities, public and private, including the State itself, are accountable to laws that are publicly promulgated, equally enforced and independently adjudicated, and which are consistent with international human rights norms and standards. It requires, as well, measures to ensure adherence to the principles of supremacy of law, equality before the law, accountability to the law, fairness in the application of the law, separation of powers, participation in decision making, legal certainty, avoidance of arbitrariness and procedural and legal transparency.” 24

SDG 16 links the rule of law to development, as a crucial foundation for the creation and maintenance of “just, inclusive and peaceful societies”. 25 In the absence of the rule of law, neither health nor development can be fully realised.

State obligations to support the right to health

Governments in virtually every legal system have both the authority and the duty to safeguard the health of the population. 15 This authority derives from domestic and international norms. Nation states derive their authority through the concept of sovereignty: sovereign governments have sole authority to make laws and regulations regarding the public's health. This principle recognises that certain risks—such as infectious diseases, natural disasters, industrial hazards, contaminated food and water—as well as the measures needed to prevent or reduce those risks, are outside the control of individuals or groups. No individual acting alone can assure the conditions for health and safety; only the State has the power necessary to intervene at the population level, through coordinated action.

Many international instruments, including WHO's constitution and treaties, contain state obligations to safeguard health-related rights. Article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) from 1966 contains the foundational expression of the right to health. 26 General Comment no. 14 of the Committee on Economic, Social and Cultural Rights (a body comprising 18 independent experts that monitor state implementation of the ICESCR by states parties) interprets and elaborates on Article 12. 27 General Comments offer guidance to states, clarifying treaty obligations and how they should be implemented. 28

According to the ICESCR and General Comment no 14, the right to health is a “fundamental human right indispensable for the exercise of other human rights”, and “every human is entitled to the enjoyment of the highest attainable standard of health conducive to living a life in dignity”. 29 States have an obligation to ensure available, accessible, affordable, and acceptable health facilities.

The state's primary obligation is to protect the health and safety of its inhabitants, not only citizens and lawful residents, but also asylum seekers, refugees, and undocumented immigrants. Traditionally, states do not have duties toward individuals in other jurisdictions. However, humanitarian law, human rights law, and WHO treaties can imply or even explicitly prescribe transnational obligations. For example, states have a duty not to make, store, or deploy banned weapons (such as chemical weapons), and not to violate fundamental human rights. The International Health Regulations (IHR) contains non-binding language encouraging state parties to help build health system capacities in lower-income states. Soft rules, such as the Pandemic Influenza Preparedness (PIP) Framework, require parties to share novel flu virus specimens and provide reciprocal benefits to other states.

When states act to ensure the public's health and safety, they can impose restrictions on private interests. 30 Public health interventions can constrain personal autonomy, privacy, or liberty, and can limit businesses' economic freedom. Finding a balance between protecting liberties and securing population health is an enduring theme in public health law and ethics. 31 Failing to strike an appropriate balance might result in disproportionate personal burdens, especially on marginalised populations. However, often, no conflict exists between individual and collective interests. For example, protecting the rights of individuals living with HIV or AIDS empowers them to access treatment, which both improves their health and reduces the likelihood of transmission. The role of the law, then, is to safeguard the health and safety of individuals and communities, while not restricting personal freedoms more than strictly necessary to fulfil health objectives.

The Siracusa Principles on the Limitation and Derogation Provisions in the International Covenant on Civil and Political Rights (ICCPR) 1985 guide states in striking the delicate balance between protecting liberties and securing population health. 32 The Siracusa Principles were developed in response to concerns about governments illegally or unjustifiably declaring martial law or a state of emergency to deny fundamental rights and freedoms. The Principles were established to determine when such departures from the ICCPR might be permissible. Restrictions might be justifiable when they are in accordance with the law; based on a legitimate objective; strictly necessary in a democratic society; the least restrictive and intrusive means available; and not arbitrary, unreasonable, or discriminatory. 33 Under international law, the Siracusa Principles are persuasive but non-binding, meaning that states should strongly consider but are not legally required to follow them.

Functions of law

Law has numerous functions, many of which directly or indirectly affect health. By “functions of law”, we mean how the law shapes societal interactions. 34 The Commission chose to focus on three crucial functions. Law can be used to establish standards and norms that guide conduct, resolve disputes, and govern public and private institutions. Throughout this report, we draw on these three functions, explaining their relationship to global health.

Establishing norms and standards in domestic and international law

In domestic law, the first duty of sovereign states is to protect the health, safety, and welfare of the population. Governments fulfil this duty principally by developing and enforcing rules and standards that structure the physical and social environment, guiding behaviour of individuals and the conduct of organisations. National constitutions typically empower governments to safeguard the public's health and might also allocate responsibilities between states or provinces and the federal government, and between legislatures, agencies, and courts.

In the health context, states set norms and standards using the following powers. 15 The power to tax and spend creates economic incentives (eg, agricultural subsidies) or disincentives (eg, tobacco taxes) for individual and corporate conduct that affects health. The power to alter the information environment and inform the public about the health effects of products (labelling, warnings, health education) or restrict deceptive marketing such as cigarette advertising. The power to alter the socioeconomic environment can create more equitable societies with fairer access to public goods (redistributive taxation, safety nets, and social welfare policies). The power to alter the physical and built environment can improve the quality of water and sanitation in communities, or can create liveable spaces and communities that are conducive to physical activity, including parks, playgrounds, or bike paths. Governments use direct regulation of people, professionals, and businesses to set and enforce rules for numerous purposes —some of these include mandating childhood vaccinations or seatbelts, establishing systems for credentialing and licensing health professionals, or determining standards for motor vehicles or pharmaceuticals.

Indirect regulation through the tort system such as product liability and tobacco litigation creates disincentives for businesses that make and sell unsafe or hazardous consumer products. Finally, legal or regulatory reform provides substantive rights in relation to health and to justice (eg, informed consent, confidentiality, privacy, non-discrimination); or deregulation, in cases where existing laws or regulations impede public health (such as law banning distribution of sterile injection equipment) or stigmatise marginalised communities (such as criminal penalties for engaging in same-sex behaviour).

States could also use inward-facing regulation to improve the machinery of government. 35 States should ensure the good governance rule of law, consisting of inclusive participation, honest stewardship of public resources, and accountability, in addition to strong regulatory capacities. For example, in 2011, the South African Constitutional Court held that the nation's constitution contained an implied governmental obligation to establish an effective anticorruption unit. 36 Inward-facing regulation can also improve the delivery of health goods and services by ensuring a strong, well-funded health system. Inward-facing regulation is related to the third function of law (governing institutions).

International law also sets norms and standards that have a direct or indirect effect on health and safety, and with which states should, or must, comply. International health-related norms include protecting the child's best interests and capacities, 37 prevention and control of non-communicable diseases, and access to essential medicines. 38 Standards that directly affect health include those for sanitary, which relate to animals; phytosanitary, which relate to plants; environmental pollution levels, and classification of diseases. 23 WHO oversees three major international legal instruments, 39 to which we refer throughout this report. The first is The Framework Convention on Tobacco Control (FCTC), an international treaty and thus legally binding; the IHR, another legally binding treaty; and The PIP Framework, which is not a formal treaty.

Many international rules were not created for a health purpose but have a profound impact on health. International trade rules (including intellectual property agreements), have far-reaching consequences for health. The relevant international regimes, their rules, and their intersection with health are described in the appendix .

Countries often have broad discretion as to how, and to what extent, they conform to international norms and standards. Full conformance often requires states to translate international norms and standards into national legislation. For example, WHO's FCTC (2003) requires states parties to adopt and implement effective national measures to ensure that tobacco product packaging and labelling do not promote tobacco products by false, misleading, or deceptive means. 40 States must act within their own legal systems to comply with international law. However, states retain sovereignty in deciding whether to ratify the treaty and in how they incorporate its requirements into their domestic law.

Domestic law can also provide greater precision than that which is expressed in expansive legal instruments. International health-related rights—such as the rights to health, privacy, and non-discrimination—are enshrined in many regional and domestic legal frameworks, including national constitutions. 41 , 42 To fully realise the right to health, governments must implement measures through domestic law and regulation ( panel 3 ). Broad international guidance requires detailed national policy making.

Case study of legal responses to infectious disease (hepatitis C)

Despite enormous gains in the treatment of disease, the increasingly globalised nature of the world nowadays has made the spread of infectious diseases across borders a persistent, global public health challenge. In seeking to contain the spread of infectious disease, countries leverage a broad array of tools at their disposal. One important tool is the law, which poses unique challenges and opportunities in its role to help contain infectious disease. The global response to hepatitis C exemplifies some of these challenges and opportunities.

Worldwide, approximately 70 million people live with chronic hepatitis C virus infection. 43 In the last decade, the development of direct-acting antivirals has provided an effective cure in the form of oral, well tolerated treatment regimens for people with chronic hepatitis C virus infection; cure rates of over 95% have been achieved with direct-acting antiviral regimens. 44 Despite the existence of an effective cure, the number of people treated for hepatitis C still remains a relatively small fraction of those infected or diagnosed. 45 , 46 Patent-related barriers that keep prices high substantially contribute to this problem. 46

Direct-acting antivirals have a wide range of patents, covering the chemical molecules, manufacturing processes, methods of treatment, and formulations. 47 Patents covering various aspects of direct-acting antivirals prevent the entry of competitors, allowing originator companies to select the price for the market. 48 Although these patents cover a broad range of features, the reality of country-specific patent regimes means that a patent granted in one country might not be granted by, or even filed in another country. In countries where patents are not filed or granted, local production or importation of generics is possible, and the competition from these generics, in turn, drops the price and increases access to the drug. An example of this was observed in Georgia and Morocco; 49 in both countries, primary patents for the direct-acting antiviral sofosbuvir were not filed. As a result, generic companies could produce that drug, enter the market, and decrease the price of the drug.

In countries where patents are issued, another set of options have been utilised by groups and countries to mitigate patent-related barriers. For example, some non-governmental organisations have been attempting to systematically test or undermine patents issued in certain countries to facilitate competition and access. 46 Many national patent regimes provide the opportunity for third party filings, which serve as a way to register concerns about whether the compound has sufficiently met the requirements of patentability. Non-governmental organisation attempts to undermine patents have led to the rejection of key patent applications for direct-acting antivirals in Brazil, China, Egypt, and Ukraine. 46 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58

Where patents exist and have been unsuccessfully challenged, another option available to groups and countries is voluntary licence agreements. These agreements formalise originator companies' permission to manufacture and sell generic versions of their drug regimens in specific countries or regions. As a result, countries included in originator companies' voluntary licensing agreements are able to access generic direct-acting antivirals from licencees at lower prices. 53 For example, one manufacturer licenced its products to eleven generic manufacturers in India, facilitating the sale of generics in more than 100 countries. 53

Countries not included in voluntary licence agreements can still increase competition and access by way of other strategies. The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), 54 an international legal agreement between all the member nations of the World Trade Organization, acts to constrain actions for countries with respect to patents. However, countries do have the right under TRIPS to grant government use or compulsory licences in certain circumstances. 54 , 55 In September, 2017, Malaysia became the first country to issue a compulsory licence for a direct-acting antiviral. 46 , 52 After issuing the licence, Malaysia was then included in the voluntary licence agreement of some manufacturers. 56

The net effect of this global patchwork of patent laws and policies is, on the one hand, a steep price cut in low-income and middle-income countries, and, on the other hand, a slowly declining price trend in upper middle-income and high-income countries. 46 The former is promising because more than 60% of people with hepatitis C nowadays live in a country that could access generic direct-acting antivirals. 46 However, not all countries that can access more affordable generic treatments do, and, still more troubling, although some competition has altered prices in upper middle-income and high-income countries, high prices of direct-acting antivirals continues to impede access to an effective cure. 46

Resolving disputes at national and international levels

The second crucial function of law is as a tool to resolve disputes between individuals, organisations, and governments. This role of the law can occur in diverse venues, including traditional courts of law, and via alternative dispute resolution mechanisms, such as mediation or arbitration. Although dispute resolution typically involves specific parties, the outcomes can reach well beyond these parties. In the following sections, we examine how two important forms of dispute resolution—strategic national litigation and international dispute resolution—have been used in the health context, and how their outcomes have been leveraged as broad public policy tools.

Strategic national litigation is the first important form of dispute resolution. Despite landmark public health litigation—on issues ranging from mental health and tobacco control, to access to medicines—the legal and public health communities continue to debate the strategic value of litigation in pursuit of public policy goals or other systemic change. Litigation is time-consuming, expensive, and technical, with unpredictable outcomes. Any individual or corporation can bring a court case, potentially furthering private interests inconsistent with the public's health. Corporations can use the courts to overturn or diminish the effect of health and safety laws, or to defend marketing unsafe or unhealthy products.

Moreover, public policy requires balancing competing interests, and courts are generally not well suited to such determinations. In right-to-health litigation, courts are charged with deciding which individuals are eligible to receive a specific health service or product. However, judges have limited facts and perspective: they must adjudicate according to the parties and evidence in front of them, rather than considering issues at the population level. Are judges better placed to decide on the allocation of scarce health resources than elected officials? When is it appropriate for a court to decide that an individual litigant is entitled to access pharmaceuticals not listed on the government's or WHO's essential medicines registries?

While acknowledging these weaknesses, and others, we believe that well targeted strategic litigation—eg, proceedings that seek systematic change and remedies that extend far beyond the individual litigants—can be effective in advancing public health, complementing other approaches.

Tobacco litigation is perhaps the most familiar example of successful strategic litigation to drive public policy. 57 In the USA, advocates and state attorney generals brought class action litigation against tobacco companies after pursuing numerous other legal and policy avenues. Tobacco control litigation, still in process, has produced two well known outcomes. The first was the 1998 Master Settlement Agreement, which forced tobacco companies to curtail marketing and to make annual payments, in perpetuity, to US states, and the second was the “Tobacco Papers”, a vast cache of internal industry documents uncovered in 1994 that revealed duplicitous industry actions such as concealing the harms of tobacco use and the addictiveness of nicotine, and marketing directed toward children and adolescents. 58

Tobacco litigation has had enduring effects on public health. The litigation exposed the unethical behaviour of industry executives, informed the public of the devastating dangers of tobacco smoke, and secured industry funds for health promotion. The Tobacco Papers are housed in a public repository, informing subsequent tobacco control measures throughout the world. 59 The FCTC emphasises the value of domestic litigation, asking parties of states to share information and strategies.

Strategic litigation can also precisely interpret broad or abstract principles, such as the right to health, leading to improved health care. Litigation on access to anti-retroviral drugs is one area in which notable success has been achieved. In Minister of Health versus Treatment Action Campaign (2002), the Constitutional Court of South Africa held that government limits on the public sector provision of nevirapine were unreasonable and unconstitutional. Nevirapine halves perinatal HIV transmission rates. The Court found that limiting access was a breach of the right to health care, which was not consistent with a positive state obligation to progressively realise the rights of mothers and infants to essential health services. 60 Similarly, the Venezuelan Supreme Court (1999) required the State to provide HIV treatment and to develop social awareness campaigns. 61 In 2000, the Argentine Supreme Court found that the “right to health falls within the right to life…the first natural right of the individual”, and directed the government to provide HIV treatment. 62 These cases, along with other right to health litigation, have contributed greatly to social movements. 63

Controversies in public health litigation have also been reported. Modelled on the cases described above, individuals have increasingly launched health rights litigation around the world on issues including reproductive rights, mental health, and smoking in public places. 64 Notably, this litigation often occurs in the context of democratic failure: litigants turn to the courts because corruption, autocratic practices, and the dominance of powerful interests provide little opportunity for changing policies through the political system. 65 Although gaining traction, 66 the justiciability of the right to health (ie, the question whether or not a court can adjudicate a claim brought on the basis of the right to health) remains a contested issue in many jurisdictions. 64 The long-term effects of litigation on equity and justice are not yet clear, 64 and are dependent on context. For example, one study of litigation in a southern Brazilian state concluded that “judicialization largely serves the disadvantaged who turn to the courts to secure a wide range of medicines.” 67 However, in other cases, courts have granted individuals access to expensive medications, some of which have little demonstrated value. When courts override careful policy assessments by the legislature, they might divert resources for health that could otherwise have been used for more cost-effective interventions. Consequently, scholars have noted: “Courts in adjudicating health human rights need to frame the right in the context of the larger equity and solidarity goals of a public health care system…one danger with a rights-based approach is that it can reinforce the individual demands for high-priced treatments, thus exacerbating the difficulties governments have in running fair and efficient health care systems.” 68

This danger was realised in Colombia, where individuals bringing legal actions known as tutelas overwhelmed the public health system in the 1990s and 2000s, requiring a judicial ruling on the limits and definition of the right to health ( panel 4 ).

Litigation as a tool to define the right to health

In 1991, Colombia enacted a new Constitution followed by a series of reforms intended to extend health insurance to all citizens. The 1991 Constitution enshrined economic and social rights, establishing a Constitutional Court as a specialised tribunal to oversee the new constitutional jurisdiction. This gave individuals the right, when economic and civil rights were not being met, to take the government to court through a writ called a tutela . 69 Tutelas give citizens an avenue to ensure that the government actively provides for their constitutional rights, including rights to health care.

However, health-related tutelas rapidly overwhelmed the tribunal. According to a report by the Human Rights Ombudsman's Office, between 1999 and 2008 there were 674 612 actions for protection of constitutional rights in relation to health issues. 70 , 71 Additionally, rather than creating a more equitable dispute resolution system for all Colombians, tutelas were often exploited by members of the wealthier class. 72 The Colombian Constitutional Court subsequently issued a sweeping decision to improve the equity and oversight of the health system and stem the tide of litigation. 73

The decision provided necessary definition and limits to the right to health for Colombia. Moreover, the Colombian Court had to carefully assess the practical and financial burden its decision would have on the government. As scholars have noted, “if health-related rights are treated as unconditional and not limited by resource capacity, this can put an unsustainable burden on public insurers and undermine the ability to [act] as wise stewards of public resources through negotiating prices or resisting patent extensions and so forth”. 68

However, individuals in many of these cases were simply seeking the treatments and other services to which they were already legally entitled. 74 As scholars from multiple disciplines have recognised, there is no inherent conflict between right to health adjudication and efficient and equitable priority setting. 75

Furthermore, litigation can be time-intensive, costly, and unpredictable, dampening its potential benefits. In the US tobacco litigation, industry defendants imposed enormous delays and high costs over the course of decades and multiple waves of litigation before health advocates eventually gained traction in the courts. 76

Many industries, including the food, beverage, alcohol, and tobacco industries often use litigation to diminish innovative public health laws. In 2012, tobacco companies successfully halted US Food and Drug Administration (FDA) regulations to mandate graphic warnings. The US Supreme Court found that the FDA rule violated the companies' constitutional commercial speech rights. Industries' use of the commercial speech doctrine has also undermined public health regulations designed to prevent obesity and other non-communicable disease risk factors.

At the international level, multiple dispute resolution systems exist, with varying degrees of effectiveness. The WTO's is among the most robust, with three main stages: first, consultations between the parties; second, adjudication by panels, followed by the Appellate Body; and finally, implementation of the ruling, including countermeasures if the losing party fails to comply. The World Bank's International Centre for Settlement of Investment Disputes (ICSID) offers another venue for transnational litigation. The ICSID is charged with interpreting bilateral or multilateral investment treaties designed to protect industry investments in governments that are parties to those treaties.

The WTO and ICSID, as tribunals, must reach judgment on the individual cases before them and not on their possible implications for public policy. In some cases, they have protected industry interests over the public's health. Tobacco companies have used both ICSID and WTO processes to challenge tobacco control laws in Uruguay (marketing restrictions) and Australia (plain packaging). The ICSID arbitration panel ruled decisively in Uruguay's favour in July, 2016, requiring Philip Morris to pay the costs of the defendant and the court.

In contrast to certain well established dispute settlement systems, WHO's treaty dispute mechanisms are weak. Under Article 27·1 of the FCTC, the parties must try to settle their disputes “through diplomatic channels”, using negotiation or mediation. If the parties cannot settle their dispute in this way, the FCTC envisages ad-hoc arbitration with the exclusive jurisdiction of an arbitration panel. However, only three countries have formally agreed to be bound by this arbitration, and the mechanism has never been used.

The IHR (2005), the WHO treaty aimed at global health security, include a dispute settlement process between state parties (Article 56), which is voluntary. State parties should first seek to resolve the dispute through negotiation or mediation, after which the matter might be referred to the Director-General. However, this voluntary dispute settlement system has never been used.

WHO's PIP Framework uses a combination of non-binding norms and legally binding contracts to achieve its aims. The PIP Framework was devised to forge a compromise among higher and lower-income countries on virus sharing and equity. The associated contracts, known as Standard Material Transfer Agreements (SMTAs), are used to bind non-state actors who would not usually be subjects of international law, such as pharmaceutical companies or academic institutions. 39 The SMTAs include a binding arbitration clause: “if a dispute cannot be resolved through negotiations or other non-binding means of the parties' choice, disputes shall be subject to binding arbitration on conditions that are mutually agreed by the parties.” 77 , 78 , 79

Other dispute resolution models beyond international legal instruments include public–private partnerships (PPPs), such as the Global Fund to Fight AIDS, Tuberculosis and Malaria; and Gavi, the Vaccine Alliance, as well as institutions such as the World Bank. These resolution models have rules and regulations related to how grant and loan resources can be used, and how they must be accounted for.

Furthermore, regional and international human rights treaties often have quasi-judicial dispute settlement systems for states that accept to be bound by them, which are available once domestic avenues have been exhausted —for example, the Committee on the Elimination of Discrimination Against Women (CEDAW), a treaty body tasked with monitoring state party compliance with the international Convention on the Elimination of All Forms of Discrimination against Women. 80 Unlike a court, a treaty body does not pass judgments, but monitors compliance and issues recommendations. In 2011, CEDAW heard the matter of Alyne da Silva Pimental Teixeira versus Brazil, which concerned human rights violations in the context of maternal mortality. CEDAW recommended reparations for the individual harmed, also recommending that Brazil reduce maternal mortality risks and discrimination against pregnant women. Brazil complied with both aspects of the decision. 81

Governing public and private institutions

Finally, law can be used to establish, structure, and oversee public and private institutions. This function overlaps with the first two functions (establishing norms and resolving disputes) primarily with respect to scope and process. Law governs the operations of government institutions that are involved in setting standards (eg, parliaments, administrative agencies, and courts), as well as corporations and non-governmental organisations. We briefly explain how law works to establish, structure, and oversee the key players and organisations in global health.

Laws can establish institutions and define the reach of their activities by setting out institutional mandates. A mandate refers to the explicit, implied, and customary powers and responsibilities of an organisation. 82 A state's constitution defines the government's obligations to safeguard the public's health and to protect personal freedoms and rights. Constitutions often establish branches of government, allocating power among them (and setting limits on those powers), and delineating responsibilities. Statutes establish a country's key agencies, such as the Ministry of Health, defining its mandate and powers, while allocating funds for its operations. Treaties establish and govern international institutions, such as WHO. The WHO constitution is a legally binding treaty that defines the organisation's mission, scope of its organisational activities, and the responsibilities of its organs (assembly, executive board, regional and country offices, and secretariat). A corporation's mandate—that is, the purpose for which the corporation has been established—is set out in its charter or founding documents, such as a Memorandum of Association. Corporations are formed under provincial or federal laws that specify their fiduciary duties, duties to report and pay tax, and other responsibilities. Statutes and regulations can define the activities, structure, and limitations of a not-for-profit organisation with a global health mission. Non-governmental organisations must abide by the legal parameters set for their operation. The proliferation of institutions working in global health has added a new level of complexity, which includes the overlapping mandates of public, private, and non-governmental organisations, and public–private partnerships. We elaborate on these issues in section 3.

Law also governs processes and institutions by providing systems of checks and balances. The classic example is the checks and balances between the legislative, executive, and the judicial branches of government, which help prevent one branch from dominating. Under this principle of government, “separate branches are empowered to prevent actions by other branches and are induced to share power.” 83 The law specifies the powers of each branch and the ways in which each branch can limit the powers of the others. The actions of legislatures and agencies are often subject to judicial review, but the legislature can override decisions of judges (other than with constitutional rulings). Checks and balances are crucial to the rule of law ( panel 5 ). 84

Checks and balances and the rule of law

The rule of law is central to achieving health with justice, and systems of checks and balances are central to the rule of law. Although checks and balances are often codified, this is not always the case. The World Justice Project notes: “governmental checks take many forms; they do not operate solely in systems marked by a formal separation of powers, nor are they necessarily codified in law. What is essential, however, is that authority is distributed, whether by formal rules or by convention, in a manner that ensures that no single organ of government has the practical ability to exercise unchecked power”. 84

However, their robustness depends on institutional design, as well as the legal system and political culture within the jurisdiction.

Although governmental checks and balances provide the classic example, a similar framework can operate within and between public and private institutions, and between institutions making decisions at different levels—eg, national governments can modify the effect of decisions made at the international level. WTO members are required to implement the 1995 Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) through national legislation recognising and enforcing pharmaceutical patents. 54 However, in many jurisdictions, these intellectual property protections have limited individuals' access to medicines. In response, governments have devised mechanisms to balance intellectual property protection with greater access to medicines. 85 Therefore, national legislation on medicines procurement or patentability criteria, as well as TRIPS flexibilities, have sought to expand social goals, while recognising private rights. 86 Yet further scope remains for countries to use the flexibilities that TRIPS provides to enable greater access to medicines. 87

Non-state actors can also provide a check on unreasonable exercise of government power. Civil society organisations are instrumental in demanding transparency and accountability from governing institutions. Non-state actors have a powerful voice in pushing governments and international institutions to use their legal tools in a manner that promotes justice and human rights, such as by protecting marginalised or disadvantaged populations. For example, advocacy on HIV has spurred government action around the world, ranging from research funding through to expanded treatment access. 88 Whether at the grassroots level or internationally, participation by non-state actors and civil society organisations in governing processes increases the legitimacy, transparency, justice, and democracy of such processes.

Key players in global health

National public health agencies and intergovernmental institutions dominated the global health landscape for decades. Although these actors remain central, the landscape is changing rapidly: new institutions are proliferating, and traditional structures of power and control are evolving (see section 3). Many of these key players do not have the power to make law, but all are subjects of law. They are parties to contracts, disputes, or rules of various kinds, and they can use their influence to either encourage or impede legal reforms.

Nation states

Nation states remain the major force in the global governance system. The nation state is “the fundamental building block of the global polity … [and] the primary authority for the negotiation of global rules.” 4 Compared with other actors, nation states have the broadest range of powers, with the sovereign power to directly govern and regulate health. While health ministries continue to oversee most public health policy making, laws made by multiple different agencies—across sectors such as agriculture, commerce, transport, and the environment—can profoundly affect health outcomes.

Moreover, nation states make up the membership of intergovernmental organisations, with a seat at the decision-making table. The major intergovernmental institutions include UN agencies and programmes, regional organisations, and economic policy forums such as the G7 and G20. Nation states also have a high degree of influence through their overseas development aid programmes, and through bilateral or multilateral cooperation.

International organisations

The UN is the primary international organisation. The UN system is charged with ensuring international cooperation, including promotion of health and human rights. UN organs and agencies have historically engaged in global health work. The WHO, formed in 1948, was the first specialised UN agency, and, under its constitution, has the primary mandate for governing global public health. For many decades, WHO remained the preeminent, if not the sole, institution in the global health space. The WHO has robust legal powers to govern global health and to encourage action among countries, including powers to make international treaties in the form of conventions and health regulations. However, many other UN bodies operate in the arena of global health, including the Food and Agriculture Organization (FAO, which has treaty-making powers) 89 the UNDP, UNICEF, the UN Population Fund (UNFPA), and UNAIDS, 90 all of which can influence both national and global health law.

Other multilateral organisations exert a substantial indirect influence on the legal and economic dimensions of global health. Of importance are the WTO and the Bretton Woods institutions. The WTO's mission is to “open trade for the benefit of all”. 91 WTO members must commit to certain legal obligations in fulfilling this mission, such as enacting strong protection for intellectual property. This may create access barriers for health services or impede public health policy by increasing the cost of essential medicines. 92

Established in 1944 with an initial mission of post-World War II reconstruction, the Bretton Woods institutions are the World Bank and the International Monetary Fund (IMF). They shape the global health landscape through their financial and economic support for global health and development. The World Bank provides financial and technical assistance to developing countries to foster income growth and end extreme poverty. 93 Since the 1970s, its loans and grants have supported a range of development priorities, including health. During 2000–16, the World Bank invested US$35 billion in health, nutrition, and population. 94 In the aftermath of the Ebola epidemic in west Africa, the Bank has focused on global health security.

The IMF is an intergovernmental institution comprising 189 member countries, with a mission “to ensure the stability of the international monetary system”. 95 Their work includes lending and capacity development, and when providing support (or bail-outs) to countries in financial difficulties, the IMF's assistance might be accompanied with conditions such as deregulation or reduced health spending. 4 , 96

Non-state actors

Just as public health at the national level is no longer the sole purview of health ministries, WHO has now been joined by an “explosion of actors in the global health arena”. 97 Non-state actors—notably philanthropies, hybrid PPPs, and civil society organisations—have become crucial to the development, influence, and funding of global health initiatives. Through financial resources as well as social mobilisation and advocacy, these organisations wield considerable influence and can use that influence to drive legal change. Corporations, including in the tobacco, alcohol, food, and beverages sectors, can have negative effects on health. The private sector also works to improve health outcomes, providing funds but also expertise and personnel in response to specific needs such as health emergencies. For example, during the 2013–14 Ebola outbreak, companies provided logistics, communications, and transportation, as well as operating treatment units. 98 , 99

Private philanthropic organisations are non-state actors that have become major funders of global health. The Bill & Melinda Gates Foundation is the single largest donor of discretionary funds to WHO. 100 This Foundation has a strong focus on technical solutions to global health challenges, investing in vaccines (eg, HIV, polio, and malaria) as well as family planning, nutrition, and maternal and child health. 101 The Rockefeller Foundation is an older, more established philanthropic foundation with a long history in public and global health, which champions UHC. Other examples of philanthropic foundations include the Clinton Foundation working on HIV and AIDS, Bloomberg Philanthropies working on tobacco control and liveable cities, Mundo Sano working on neglected tropical diseases, the Children's Investment Fund Foundation working on child health and poverty, and the Fundación Carlos Slim, working for health, justice, and community development. 7 , 102 , 103 , 104 Other prominent philanthropies include The Arab Gulf Programme for Development, working on poverty alleviation, human development, and human rights; the Aga Khan Foundation, addressing human development and strengthening civil society organisations; and the Sasakawa Memorial Health Foundation, working on leprosy, and rights of people with disabilities.

A defining feature of the global health governance landscape is the rise of PPPs: hybrid structures made up of non-state actors (eg, businesses, philanthropies, and civil society organisations) working jointly with governments and health agencies. These partnerships have both economic and legal dimensions. PPPs respond to the desire of funders to exercise greater control over the use of their resources, and to bypass bureaucratic and governance barriers in the UN system. Institutions established as PPPs often have a specific mandate, with control and influence shared by the public and private partners. They exist on a continuum, in which some are more public in nature (eg, largely financed funding agencies that include private actors on their boards), whereas others are closer to private institutions—eg, entities working closely with the private sector to accelerate research and development ( figure 2 ). 105

The public–private partnership continuum

Adapted from National Academy of Sciences, Engineering, and Medicine, 105 by permission of The National Academies Press.

The largest PPPs operating in global health include the Global Fund to Fight AIDS, Tuberculosis and Malaria; and Gavi, the Vaccine Alliance. Unitaid is a PPP that invests in innovations to prevent, diagnose, and treat HIV, tuberculosis, and malaria. The Coalition for Epidemic Preparedness Innovations is among the newer PPPs, working to galvanise the development of new vaccines against diseases with pandemic potential. In 2016, the US National Academy of Sciences found that PPPs could deliver “improved responsiveness and accountability to society and…better outcomes in shorter timeframes.” 105

Civil society organisations—primarily non-governmental organisations—have long been influential in global health as advocates for research and treatment, and for human rights. Among the most well known non-governmental organisations are Médecins Sans Frontières, CARE International, the International Red Cross and Red Crescent, Oxfam International, Save the Children, Rotary, and Caritas. Many of these civil society organisations work primarily in the humanitarian and development sectors, and as first responders to health emergencies (eg, in natural disasters, epidemics, and war zones).

Other civil society organisations, such as the Center for Reproductive Rights, focus their efforts (including leveraging the law) on advancing international health and human rights. There are also civil society organisations at the country level undertaking grassroots social mobilisation and advocacy, such as the Treatment Action Campaign (HIV) and Section 27 (the right to health) in South Africa, and the Center for Health, Human Rights and Development in Uganda. Patient rights groups have also been powerful advocates for government policy, legal change, and funding, including in relation to HIV, tuberculosis, and Alzheimer's disease, as have professional and scientific associations and networks such as the American Heart Association and the International Council of Nurses. Although these rights groups are often left out of formal global diplomacy, civil society organisations can be an influential voice for human rights and the right to health, especially domestically, as well as in multi-partner alliances such as the Framework Convention Alliance on Tobacco Control. 106

Section 1 provided an introduction to the legal system for global health, including explanations of three key functions of law and the key players. We now turn to the substantive ways in which law can affect health and justice, which we characterise as the legal determinants of health.

Section 2: legal determinant 1

The first legal determinant can be used to translate vision into action on sustainable development. This determinant relates to the power of law to channel the SDGs' unifying vision for global health into concrete action. We first briefly describe the SDGs' agenda for global health. Because UHC is so crucial to the future of global health, we present a case study showing how law can advance the SDGs' bold vision of health and justice. We examine the legal foundations of UHC, as well as legal mechanisms for its implementation.

The SDGs and global health

Adopting the 2030 Agenda for Sustainable Development in September, 2015, the UN General Assembly articulated a transformational vision: “We envisage a world free of poverty, hunger, disease and want, where all life can thrive. We envisage a world free of fear and violence. A world with universal literacy. A world with equitable and universal access to quality education at all levels, to health care and social protection, where physical, mental and social well-being are assured. A world where we reaffirm our commitments regarding the human right to safe drinking water and sanitation and where there is improved hygiene; and where food is sufficient, safe, affordable and nutritious.” 14

Member states promised to rigorously implement this agenda, which comprises 17 goals (the SDGs) and 169 targets, by 2030. They replace the Millennium Development Goals (MDGs), while building on their success, expanding their scope, and highlighting unfinished business. Committing to “leave no one behind”, the SDGs articulate an equity agenda, developed through a crosscutting multisectoral strategy involving a consultative, grass-roots process. 107

Health in the SDGs

Although the MDGs included several health-specific goals, 108 the SDGs have a single unifying health goal. Goal 3, supported by 13 targets, aims to “ensure healthy lives and promote well-being for all at all ages”. 109 Referencing the millions of preventable deaths, including deaths of children and childbearing women, goal 3 states: “these deaths can be avoided through prevention and treatment, education, immunization campaigns, and sexual and reproductive healthcare. The Sustainable Development Goals make a bold commitment to end the epidemics of AIDS, tuberculosis, malaria and other communicable diseases by 2030. The aim is to achieve UHC, and provide access to safe and affordable medicines and vaccines for all. Supporting research and development for vaccines is an essential part of this process as well”. 109

Several other SDGs directly relate to the conditions needed for healthy people and healthy communities. For example, goal 2: “end hunger, achieve food security and improved nutrition and promote sustainable agriculture;” 110 goal 5: “achieve gender equality and empower all women and girls”; 111 and goal 6: “ensure access to water and sanitation for all”. 112

Virtually all other goals include targets that relate directly or indirectly to health, such as: targets 4·2 (access to early childhood development and care); 7·1 (affordable modern energy services); 11·6 (adverse environmental impact of cities, with special emphasis on air pollution); 13·1 (climate related hazards and natural disasters, and related mortality); 16·1 (reducing violence-related deaths); 16·9 (legal identity for all, including birth registration); and 17·19 (measuring statistical capacity-building, including the registration of births and deaths). 14

Justice in the SDGs

At the core of the SDGs' vision is equal and universal access to health care and justice, with an emphasis on their interrelationship. For example, goal 3 aims to “ensure healthy lives and promote well-being for all at all ages”, 109 and includes targets such as achieving UHC (target 3·8). 109 Goal 3 also relies on the concept of justice in its targets. Target 3·b focuses on building support for “research and development of vaccines and medicines for the communicable and non-communicable diseases that primarily affect developing countries”. 109 This goal relies in part on concepts of justice embodied in transnational legal agreements, such as the Doha Declaration and the Agreement on Trade Related Aspects of Intellectual Property Rights. 113 Furthermore, goal 16 aims to “promote just, peaceful and inclusive societies”, and calls for “access to justice for all, and building effective, accountable institutions at all levels”. 113 A goal 16 target promotes “the rule of law at the national and international levels”, ensuring “equal access to justice for all”. 114 This formalises a longstanding understanding that the pursuit of justice is an essential ingredient of sustainable development. 115

The role of law in realising the SDGs

With health linkages throughout the SDGs, the potential to advance health through realising the SDGs is vast. However, the ability of law to achieve this remains largely untapped and requires an enhanced understanding and recognition of how best to use law in different SDG areas. For example, climate change—which threatens the health SDGs and many others—is directly addressed in SDG 13, and is an area where the use of law is robust (eg, UN Framework Convention on Climate Change, the Paris Agreement, carbon taxes, and renewable energy incentives). However, the use of law specifically to address the interaction between health and climate change is less well developed and is an important agenda item for the future.

The SDGs and their targets give greater specificity to the broad principles expressed in the right to health. Going well beyond health-care services, they encompass the multiple conditions needed for health and safety throughout the lifespan. In turn, law can help give these goals tangible effect, moving the question from “what is sustainable development?” to “how can sustainable development be achieved?” 116 Governments use all three functions of law to establish the frameworks of authority needed to move from principles to actions. In relation to the SDGs, laws are essential to enshrine the right to health in national policy and to oversee the quality of health professionals and hospitals through licensing and accreditation (eg, establishing norms and standards); to adjudicate disputes between individuals, health providers, and the State (eg, resolving disputes); and to establish new institutions with a specific or broad health mandate (eg, governing institutions).

Regarding a broad, aspirational statement like SDG 3 (“ensure healthy lives and promote well-being for all at all ages”), law can provide detail and accountability. What does the concept of healthy lives mean? Who is obligated to ensure the conditions for health and safety? Through what mechanisms will they do so? To what standards will they be held? How will they be held accountable for good performance? UHC offers a good illustration of the way in which law can translate vision into action on sustainable development. In the next section, we use UHC as a case study to identify the ways in which law functions both to lay the foundations for, and to implement, health for all.

Case study: law as a tool to achieve UHC

Uhc as a crucial component of sustainable development.

Nationally and globally, there exist profound differences in health outcomes, the socioeconomic determinants of health, and the availability and affordability of quality health services. The WHO and the World Bank both estimate that at least half of the world's population cannot obtain essential health services. 117 The most glaring inequities in health outcomes often correlate directly with unequal access to health services: service coverage is often poorest where needs are greatest. 118 These inequities occur both between countries (healthy life expectancy is 44·4 years in Sierra Leone, compared with 74·9 in Japan) 119 and within countries (ethnicity, geography, and socio-economic status can greatly reduce the accessibility and quality of health care). 120 For example, in Australia, life expectancy for Aboriginal and Torres Strait Islander men born from 2010 to 2012, was 10·6 years lower than that of non-Indigenous men. The discrepancy for women was nearly as wide at 9·5 years. 121 The WHO views UHC as among its highest priorities. 8 , 117 , 122 , 123 , 124 , 125 In 2005, the 58th World Health Assembly (WHA) adopted a resolution for sustainable health financing, universal coverage, and social health insurance, calling on countries to plan for the transition to UHC. 126 Since then, UHC has become a global priority and a central element of WHO's efforts to strengthen health systems and improve the quality and distribution of health and health services. 127 , 128 , 129 With the UN General Assembly adopting the SDGs in September, 2015, UHC became a global target, which will be reinforced by the UN high-level meeting on UHC in 2019. 130 SDG 3·8 views UHC as “financial risk protection, access to quality essential health care services and access to safe, effective, quality and affordable essential medicines and vaccines for all”. 113 SDG 3·8, if fully implemented, would help realise the universal right to health.

Definition and basic principles

UHC does not have a uniform definition and its variable meanings have created uncertainty. The World Bank offers a broad, conceptual framing: “UHC is about people having access to the health care they need without suffering financial hardship.” 131 WHO gives a more detailed definition, noting: “UHC means that all people can use the promotive, preventive, curative, rehabilitative and palliative health services they need, of sufficient quality to be effective, while also ensuring that the use of these services does not expose the user to financial hardship.” 132

WHO emphasises equity in access to health services (everyone who needs services should get them, not only those who can pay for them); the quality of health services; and protection against financial risk—ensuring that the cost of using services does not put people at risk of financial harm, so that people's ability to pay is not linked to their ability to access health services.

UHC has been defined as a practical expression of the right to health, 133 drawing together all the health-related SDGs. However, it focuses primarily on access to and provision of health care, whereas the right to health is considerably broader, embracing multiple conditions for healthy and safe lives, such as potable water, nutritious and safe food, adequate housing, and clean air.

Health systems range from national health systems with single or multiple payers, to government subsidised access, to public or private insurance; therefore, no single path exists to UHC. 134 However, countries embracing UHC tend to consider health a basic human right, often enshrined in their national constitutions or laws. Since 2010, over 100 countries have sought technical guidance from WHO and the World Bank to move towards UHC. 135 Countries representing half of the world's population (Brazil, China, India, Russian Federation, and South Africa) are engaged in health system reforms to extend service coverage and increase financial protection. 135

Although UHC often faces political resistance because of cost, the World Bank regards it as high value for money. 134 UHC brings direct benefits such as improved population health and more productive societies. 136 Health coverage also contributes indirectly to development, as healthy children learn better, 137 , 138 and healthy populations facilitate economic growth. 139 , 140 Furthermore, studies show that for every dollar spent on key health services, the direct and indirect benefits would exceed costs by a factor of between 9 and 20, further showing the benefits that arise from investing in health. 3

Legal foundations of UHC

The duty to provide UHC derives from two sources of law: national and international.

Regardless of a government's motivation for pursuing UHC, the legal foundations remain the same in that a state has the sovereign duty and authority to safeguard the public's health and safety. 15 The State's duty and power to implement UHC derives from its constitution or legislation. For example, Thailand's constitution, promises that “health is considered as an entitlement of Thai citizens and equal access to basic health services should be guaranteed.” 141 , 142 Brazil's Constitution likewise recognises health as a social right. 86 , 143 In other jurisdictions, national public health legislation provides the mandate for UHC.

A legal right to health services is important but not sufficient. Governments must abide by the rule of law to develop, implement, and adjudicate a UHC framework. If the rule of law is weak, it will be difficult to engage other legal mechanisms to achieve not only UHC, but also more basic tasks of governance. If public officials or health professionals are corrupt, it will be difficult to garner the resources and ensure the equity and functionality of UHC.

International law creates robust obligations to safeguard the right to health, strengthening states' domestic duty. The ICESCR (Article 2·1) requires states parties to: “take steps, individually and through international assistance and co-operation, especially economic and technical, to the maximum of its available resources, with a view to achieving progressively the full realization of the rights recognized in the present Covenant by all appropriate means, including particularly the adoption of legislative measures”. 26 , 144

Specifically, under Article 12, states parties “recognize the right of everyone to the enjoyment of the highest attainable standard of physical and mental health”, and undertake to take steps on concrete health goals, including the “prevention, treatment and control of epidemic, endemic, occupational and other diseases”. 26 , 144

As described above, the UN Committee on Economic, Social and Cultural Rights offered an authoritative interpretation of “the right to the highest attainable standard of health” in General Comment 14. 29 Beyond the ICESCR, many treaties safeguard health rights, including non-discrimination in access—for example, the UN Convention on the Rights of the Child, the Convention on the Elimination of all Forms of Discrimination Against Women, and the Convention on the Rights of Persons with Disabilities. Even though states may be parties to different treaties, the overwhelming majority of countries are party to at least one treaty that embodies the right to health, making it a virtually universal standard.

Human rights treaties place the primary responsibility for ensuring the right to health on governments. Yet, governments are also obligated to provide international assistance to protect and promote the right to health, for example under article 2(1) of the ICESCR. The concept of shared responsibilities for health has a “solid textual foundation”. 42 The Office of the UN High Commissioner for Human Rights (OHCHR) guidelines on maternal morbidity and mortality and human rights, the UNAIDS and OHCHR guidelines on HIV and AIDS and human rights, and the Maastricht Principles on Extraterritorial Obligations of States in the Area of Economic, Social and Cultural Rights all confirm the international obligation to provide assistance on UHC. Furthermore, the UN Special Rapporteurs on the Right to Health have been clear on the obligations of states in so-called hard law and soft rules. 145

Because states hold the primary responsibility to create and maintain UHC, many argue that gaping inequalities between countries are beyond legal remedy. We reject this proposition. The international community holds a responsibility to reduce health disparities, and international health assistance will remain an important funding source. Low-income and middle-income countries do need to devote a higher percentage of their gross domestic product (GDP) into health systems, but still might be unable to afford the estimated US$86 per capita (2012) required for UHC, and $112 per capita (2014) to achieve the health SDG. 146 , 147 The first Special Rapporteur on the Right to Health, Paul Hunt, observed that “if there is no legal obligation underpinning the human rights responsibility of international assistance and cooperation, inescapably all international assistance and cooperation is based fundamentally upon charity. While such a position might have been tenable 100 years ago, it is unacceptable in the twenty-first century.” 148

Although there is a strong ethos of charitable discretion in international health assistance, sustainable funding requires a mutual sense of responsibility between those providing and those receiving assistance. 149 Otherwise, the international system creates a situation in which governments can blame each other for not doing enough. 150 Moreover, in low-income countries, or those with unstable governments, weak health systems can exacerbate vulnerabilities leading to extremism and violence.

Development assistance for UHC is essential to global security—both health security and human security. In this regard, countries have existing commitments: under the UN Charter (to cooperate in achieving the universal observance of human rights) and the ICESCR (to provide international assistance and cooperation). Therefore, establishing an international legal or regulatory framework to clarify the obligations of international health assistance would be appropriate. Under such a framework, countries could, for example, agree to devote a percentage of their GDP towards national UHC, while higher-income countries agree to fill financing gaps through international development assistance for health.

The role of law in achieving UHC

Law provides both the mandate for UHC and the tools to achieve it. However, although the mandate is universal (based on the right to health) the means of realising UHC differ from country to country, depending on the legislative and regulatory mechanisms available, as well as policy choices. These mechanisms and choices will affect each of the crucial measures of UHC: access, equity, quality, cost, and choice. All these measures are important, but they also entail subtle or overt political choices or trade-offs. For example, universal access to high quality services, equitably distributed, has substantial economic costs. If governments place a high value on individual choice in the private market, this will affect measures such as access, equity, quality, and cost. 151 States, of course, are not entirely restricted in the ability to make trade-offs: their actions are constrained, at the very least, by their human rights obligations—especially the right to health.

In its report about health systems financing, WHO noted, “all countries must make choices and trade-offs, particularly in the way that pooled funds are used”. 152 The trade-offs inherent in realising UHC are often depicted as a cube ( figure 3 ), in which the X-axis depicts the population (who is covered?), the Y-axis depicts the cost (the proportion of direct costs that are covered from pooled funds, that is, prepaid funds from different sources that are accumulated and used to cover everyone who is part of the pool, such as the entire population), and the Z-axis depicts the services covered. Moving closer to universal coverage means expanding the cube: extending coverage to more people, including the marginalised and vulnerable; offering more services to meet essential health needs; and paying a greater part of the cost, thereby protecting citizens from impoverishment. 152

Universal Health Coverage cube

Adapted from WHO, 152 by permission of World Health Organization.

Increasing coverage also requires good governance, and an understanding of both the documented and practical gaps in UHC: the possible “bottlenecks and weaknesses that prevent health systems from serving the entire population and from providing the full suite of priority services at a cost that is affordable and sustainable.” 86 Crucially, UHC must be understood as effective, affordable access to quality health services (UHC in practice)—and not merely covering everyone with some form of insurance, regardless of whether they can in fact access quality health services (UHC on paper). Effective access, particularly for those with the least means, will not only depend on how health systems are designed (eg, strengthening primary health services), but also on how health insurance systems are designed. Legal strategies relating to each axis of the cube ( figure 3 ), in addition to good governance, are further discussed.

The X-axis, or, the population axis, describes who is covered. The term “universal” in UHC relates to a state's duty to provide health services to all people under its jurisdiction. Without adequate legal frameworks to support it, so-called universality might be no more than an aspiration, doing little to change “policies under which many governments either deliberately or passively refuse to grant access to health services to some people living within their national borders”. 153

Governments often exclude a wide swath of vulnerable people from high quality services, including asylum seekers, refugees, undocumented immigrants, expatriate workers, indigenous peoples, nomadic people, or groups that are historically marginalised because of sexual orientation, gender identity, sex characteristics, disability, political beliefs, or religious affiliation. 153 , 154 These populations are often already vulnerable, and least able to afford out-of-pocket health care expenditures; they are precisely the groups a UHC system should aim to cover. For example, in Rwanda, households are means-tested on their assets and revenue and stratified accordingly. The government then pays premiums for the 25% of the population who have been classified as the most vulnerable. 155

The law should inclusively define the meaning of the term universal in a country's UHC scheme, as well as providing redress in cases of discrimination or service denial. This can be achieved by enshrining the right to health in a country's constitution or legislation; 152 establishing a patient charter of rights that defines the right of access to the scheme, along with a dispute resolution system to deal with complaints by those who are denied health services to which they are entitled; 86 empowering a health-care ombudsman or health-care commission with powers to investigate breaches of the State's duty to provide health services; decentralising or devolving health systems management, so that people can access services (including dispute resolution) at the local level, without having to travel; regulating the way in which health insurance schemes (public and private) deal with membership and coverage, such as banning insurers from discriminating against individuals with pre-existing conditions and requiring coverage of essential services such as vaccines, primary care, nutrition services, and child and maternal health; and ensuring statutory protection for the security, privacy, and confidentiality of health information. 86

The Y-axis, or, the cost axis, describes financing in UHC. Governments express genuine concerns about financing UHC. 152 Full funding entails developing health systems that can deliver all required health services that are of good quality and readily accessible to the whole population. Sustainable financing can involve one of two strategies. Governments can allocate more of their overall budget to health—for example, at least 5% of GDP. 156 , 157 Alternatively or in addition, they can find new ways to raise revenue, whether by improving general tax administration and collection, increasing existing taxes, or introducing new taxes. 152

States can raise revenue for UHC in a variety of ways. In countries with a longer history of UHC, funds are traditionally raised through compulsory pre-payment schemes, such as taxation, compulsory insurance contributions, or a combination of both. 86 Conversely, low-income and lower-middle-income countries that have moved towards UHC are using novel mixes of funding mechanisms for their national health insurance models. 158 These include general taxes, earmarked taxes (eg, raised from taxing unhealthy products such as tobacco, alcohol, sugary beverages, or from airline taxes—a key source of financing for Unitaid), payroll deductions, household premium contributions, and in some cases, foreign assistance (eg, about half of the financing for South Africa's UHC programme comes from the US President's Emergency Plan for AIDS Relief). 134 , 158 , 159 However, countries, should not overly rely on international health assistance because it can be inconsistent and unreliable, impeding the government's ability to plan for and finance its health system over the long term. Additionally, donors often give preference to their own special areas of health need, which might not match what the host population needs.

Moreover, countries should generally avoid voluntary schemes (those in which people are not required to purchase insurance) as these schemes are not effective ways to achieve UHC. Increasing—or, particularly in the case of sugary beverages or other categories of unhealthy foods, initiating—taxes on unhealthy products is a particularly promising route, which creates a direct, positive health effect while also raising revenue ( panel 6 ).

Policy options that involve the use of law and regulation, from WHO's menu of policy options on non-communicable diseases160

Tobacco use

• • Increase excise taxes and prices on tobacco products
• • Implement plain or standardised packaging and large graphic health warnings on all tobacco packages
• • Enact and enforce comprehensive bans on tobacco advertising, promotion, and sponsorship, including cross-border advertising and using modern means of communication
• • Eliminate exposure to second-hand tobacco smoke in all indoor workplaces, public places, public transport, and in all outdoor mass-gathering areas
• • Provide cost-covered, effective, and population-wide support (including brief advice, national toll-free quit line services, and treatment for addiction) for tobacco cessation to all those who want to quit smoking
• • Implement measures to minimise illicit trade in tobacco products

Harmful use of alcohol

• • Increase excise taxes on alcoholic beverages
• • Enact and enforce bans or comprehensive restrictions on exposure to alcohol advertising (across multiple types of media)
• • Enact and enforce restrictions on the physical availability of retailed alcohol (via reduced density of retail outlets and reduced hours of sale)
• • Enact and enforce drink-driving laws and blood alcohol concentration limits via sobriety checkpoints
• • Establish minimum prices for alcohol if applicable
• • Enact and enforce an appropriate minimum age for purchase or consumption of alcoholic beverages
• • Restrict or ban promotions of alcoholic beverages in connection with sponsorships and activities targeting young people

Unhealthy diet

• • Reduce salt intake through the implementation of front-of-pack labelling
• • Eliminate industrial trans fats through the development of legislation to ban their use in the food chain
• • Reduce sugar consumption through effective taxation on sugar-sweetened beverages
• • Implement subsidies to increase the intake of fruits and vegetables
• • Replace trans fats and saturated fats with unsaturated fats through reformulation, labelling, fiscal policies, or agricultural policies
• • Limit portion and package size to reduce energy intake and the risk of becoming overweight or obese
• • Implement nutrition labelling to reduce total energy intake (kcal), sugars, sodium, and fats

Physical inactivity

• • Ensure that macro-level urban design incorporates the core elements of residential density, such as connected street networks that include sidewalks, easy access to a diversity of destinations, and access to public transport
• • Provide convenient and safe access to quality public open space and adequate infrastructure to support walking and cycling

Each of these mechanisms can raise legal issues. For instance, donor funding is often underpinned by international agreements with donor countries or organisations—eg, World Bank or Global Fund payments come with clear contractual conditions. Moreover, UHC programmes that combine public and private funding for health raise governance challenges, underlining the need for appropriate and robust oversight and regulation of coverage plans. For example, the Insurance Regulatory Authority in Kenya regulates insurers, including licensure, quality assurance, and consumer protection and education. 161 Earmarking (also known as hypothecation) can be a useful way to raise revenue and target behavioural health risks, as in the case of tobacco taxes that are earmarked for health spending. However, existing laws may prohibit the use of earmarking, and the practice is seen as contentious because it constrains fiscal policy making.

Furthermore, at each stage of the financing process (from revenue raising, to pooling, to the purchasing of services by providers and governments) regulation plays an important role in ensuring funds are allocated fairly and transparently. 86 Regulatory agencies are often empowered to require full disclosure of finances, and can oversee the efficiency and honesty of funding flows.

The Z-axis, termed the services axis, determines which services are covered in UHC. Health financing also concerns “the efficiency, equity, and effectiveness of the ways in which resources are raised, pooled, allocated, and used to achieve desired health systems outcomes”. 134 As WHO has warned, “pooled funds will never be able to cover 100% of the population for 100% of the costs and 100% of needed services. Countries will still have to make hard choices about how best to use these funds”. 152 This statement is in relation to the third axis of the UHC cube which describes the services that are covered. When deciding what is covered and what is not, the central challenge is to achieve the right balance between preventive, health promotion, and treatment services, in a way that is equitable and does not entrench inequities within populations. 162 Prioritisation and selection of health services are driven by national disease burden and priorities, which in turn should be determined by evidence of cost-effectiveness, affordability, and health impact. A country's essential medicines list, for example, ought to be based on population needs, evidence of effectiveness, and cost.

Law and regulation are integral to making difficult choices, because they establish processes and institutions to guide transparent decision making. States use legal processes to express national health priorities, and legal frameworks define and delineate that which is possible for a state to achieve. In determining what is and is not covered, states use a variety of legal mechanisms and institutions, including the following four examples. First, independent statutory authorities are tasked with reviewing clinical and epidemiological evidence and providing advice to governments about the effectiveness and cost-effectiveness of treatments and technologies—for example, the UK's National Institute for Health and Care Excellence. Second, administrative agencies are tasked with determining which medications are placed on formularies, and the amount or extent of any government subsidy. Third, legislation can specify which services, or categories of services should be provided under a UHC scheme. Finally, courts and tribunals can make de-facto decisions on service prioritisation. In South Africa, the Constitutional Court required access to antiretroviral medication for pregnant women, 60 while in Brazil the judiciary has ruled on numerous claims of denial of access to medicines. Conversely, Colombia's Constitution Court required priorities to be decided through a participatory, evidence-based process ( panel 4 ). Litigation can raise its own problems, including the concern that it could favour wealthy litigants and thus entrench health inequalities. 163

Finally, good governance is an important role of the law in achieving UHC. An effective UHC programme requires a process of monitoring, evaluation, and accountability, including independent review, dispute resolution, and a compensatory process in the event of adverse outcomes, as well as other administrative, political, legal, and social remedies. 164 Again, law plays a vital role. Because health sector corruption drains scarce resources, eliminating corruption is an essential component of good governance.

The World Bank and WHO have developed a UHC monitoring framework that focuses on three key components: quality, essential health services, and financial protection. 165 In December, 2017, these two agencies launched the global monitoring report on tracking UHC. 117 The report uses a set of indicators to monitor service coverage and financial protection. It indicated that about 800 million people around the world spend more than 10% of their household budget on health care, and almost 100 million people are pushed into extreme poverty each year because of out-of-pocket health expenses.

Monitoring and evaluation provide crucial information on health system performance, which assists countries in making further progress towards UHC. 118 Data could assist governments in selecting services, making wise investments, and evaluating progress, particularly for marginalised populations or those with special disease burdens. UHC requires a legal framework that adequately protects patient privacy while retaining information integrity and security.

Law can also promote good governance in UHC adoption and implementation, including transparency and inclusive participation. Although public participation in law making varies from country to country, transparency and participation are widely agreed cornerstones of effective governance. 166 For example, civil society participation in health policy can improve decision making and secure grassroots support for UHC. Robust public accountability and participation are more likely to result in reasonable and legitimate decisions, and fair, effective implementation. Such mechanisms are essential when deciding on the overall strategy, the specific pathways, and the appropriateness of central trade-offs, for UHC. 118

Finally, a functional UHC programme requires a framework for dispute resolution, with explicit rules to guide those seeking relief. Different mechanisms for review and dispute resolution exist, including litigation and alternative dispute resolution. Considering the many public and private claims that arise under UHC, a country could establish a separate adjudication process for individual claims, similar to the Colombian tutela example ( panel 5 ). Other models include a childhood vaccine compensation system to cover rare adverse events caused by immunisation, as is present in the USA.

Law gives tangible form to the SDGs' goal of good health and wellbeing

Law provides mechanisms through which the vision and aspirations of the SDGs can be realised. Through this UHC case study, we have discussed multiple entry points by which law can influence UHC, from its legal foundations, to the establishment of fair and effective monitoring systems. The vital role of law and regulation is often overlooked; this case study makes visible the ways in which bad, or non-existent, laws might undermine UHC. Conversely, it shows where well-designed and well-implemented laws can support its achievement, and in so doing, give tangible form to the SDG promise of good health and wellbeing for all.

Recommendations 1 and 2 relate to national and international regulatory frameworks to strengthen national health systems, consistent with the SDG target of UHC. Recommendation 1 calls on the UN and WHO, along with international partners, to support the achievement of SDG 3·8 by setting standards on implementation and compliance. Recommendation 2 gives greater detail at the national level: we urge governments to strengthen or create a legal framework to ensure rights-based UHC, and we set out key functions of such a framework.

Section 3: legal determinant 2

Governance challenges and the role of law.

The second legal determinant states that law can be used to strengthen the governance of national and global health institutions. The field of global health is complex, comprising a web of institutions, norms, and processes at the global, national, and subnational levels, in which activities might overlap, come into conflict, or leave gaps. Institutional fragmentation undermines the effective functioning of the global health system. Our second legal determinant of health relates to institutions and governance.

Although governing is what states do, governance is a more diffuse concept, encompassing a broad range of actors, processes, and forces. 167 Law is central to governance, but governance goes beyond law. We follow the Lancet -Oslo Commission's definition of global governance: “The complex of formal and informal institutions, mechanisms, relationships, and processes between and among states, markets, citizens, and organisations, both intergovernmental and non-governmental, through which collective interests on the global plane are articulated, rights and obligations are established, and differences are mediated.” 168

The Lancet -Oslo Commission gave sustained attention to systemic weaknesses in global governance for health, emphasising that norms, policies, and practices arising from transnational interaction serve as political determinants of health that cause and perpetuate health inequities. 4 The Commission noted that global governance for health requires a global economic and political system that is rooted in commitments to global solidarity and shared responsibility. 4 Here, we build on those findings by specifying areas where law can be used as a tool to strengthen governance for health. We identify three key governance challenges and propose ways in which law can strengthen and improve global governance for health.

Achieving good governance remains a work in progress. Failures of governance, including the WHO's response to the west Africa Ebola epidemic, or national scandals relating to food poisoning, or tainted milk or medicines, highlight institutional and systemic weaknesses. Yet, institutions can also be remarkably effective, for instance in preventing or quickly containing outbreaks, in empowering marginalised and disadvantaged populations, or in catalysing funding for neglected health priorities. The law offers tools, some of which are still evolving, which can build upon these successes and help strengthen the institutional landscape.

Challenge 1: fragmented and overlapping mandates of actors and institutions

The mandates of national and global health actors frequently overlap, which can impede the effective use of law to set norms and standards, and to resolve disputes.

At the national level, multiple ministries can have profound and sometimes conflicting effects on health, resulting in policy incoherence. A country's agriculture and health ministries, for example, often both have a mandate to regulate the safety and quality of the food supply. Ministerial mandates might overlap (eg, with regard to responsibility for food safety at various points in the supply chain) or might conflict. For example, agricultural policies could be inconsistent with health and nutrition policies: the Ministry of Health's (public health) aim of reducing sugar consumption could conflict with the Ministry of Agriculture's (economic) aim of increasing sugar production. 169 A further example might be evident within countries, for example China, which supports a state tobacco industry in which economic growth and health might be in conflict.

Similar overlaps occur at the international level, in which non-health actors can have a profound effect on global health outcomes. However, the mandates, rules and decision-making processes of these entities rarely take population health into account. International organisations that deal with trade, investment, intellectual property, security, and the environment are among the non-health regimes that can have major impacts on human health ( appendix ).

Given the broad definition and remit of global health, multiple institutions can claim a mandate on particular issues. States, international organisations, and private funders, each deriving their mandate from a different legal source, could be involved jointly or separately in the same project or problem. For example, in relation to reproductive health, and maternal and child health, the activities of WHO, UNFPA, UNICEF, agencies like the United States Agency for International Development, and non-governmental organisations might overlap, conflict, or be hampered by poor coordination. Similarly, multiple institutions operate in the HIV and AIDS space, including WHO, UNAIDS, the Global Fund, and Unitaid (a WHO hosted partnership). Accomplishing results on complex problems requires organisations to act in a well coordinated manner—for example, WHO, FAO, and the World Organisation for Animal Health must work in conjunction to prevent the spread of antimicrobial resistant organisms.

In theory, the potential for overlap, gaps, inadequate coordination and fragmentation could be minimised by recourse to a sovereign decision-making authority or an authoritative dispute resolution body. The International Court of Justice (ICJ) is the UN's judicial organ, with the power to determine whether certain activities are within the mandate of UN organs and specialised agencies. The ICJ decided in 1996 that WHO did not have a mandate to deal with the legality of nuclear weapons. 170 However, global health governance involves multiple institutions beyond UN organs and agencies. The ICJ has no jurisdiction over these institutions and cannot determine whether activities fall within their mandate. Even within the sphere of the UN, the ICJ's role as an arbiter is quite limited in practice.

Fragmentation also exists in the international legal system governing global health. International law lacks a normative or institutional hierarchy, 171 meaning that multiple venues could have jurisdiction over similar issues. This fragmentation affects the way in which law functions to set standards and resolve disputes. For example, the WTO, WHO, and the UN Human Rights Council (UNHRC) each have a mandate to set norms that affect access to pharmaceutical drugs. However, their mandates require the institutions to examine problems arising in trade, public health, and human rights through different legal lenses. This approach leads to conflicting outcomes: the WTO will continue to prioritise international trade and intellectual property, while WHO and the UNHRC will prioritise affordable access to medicines and the right to health. With limited avenues and no global sovereign entity, global health continues to rely on the traditional tools of international diplomacy to resolve conflicting decisions across international organisations—with mixed results.

In dispute resolution, parties may seek to use the fragmentation of international law to their advantage. States and other actors engage in so-called forum shopping (choosing the venue based on the outcome sought), leading to inconsistent standards. 171 , 172 , 173 Tobacco giant Philip Morris reorganised its corporate structure in order to use the most favourable investment treaty to challenge Australia's plain packaging legislation (a 2015 arbitration panel found this to be an abuse of process). 174 Meanwhile, the tobacco industry apparently funded a few WTO member states in order to access the WTO dispute resolution system and challenge Australia's plain packaging law.

Addressing the challenge of fragmented institutional mandates

Law can be an effective tool to harmonise mandates, clarify functions, and promote multiagency cooperation. Law can be used to designate the responsible agency to resolve a particular issue, or to create new entities to coordinate activities across multiple agencies. General legal principles can inform and direct all institutions to abide by and promote the rule of law, with particular attention to social justice. SDG 16 on the rule of law includes target 16·3: “promote the rule of law at the national and international levels and ensure equal access to justice for all.” 114

UNAIDS offers a prime example of an institution that spans multiple UN agencies operating to prevent and treat HIV and AIDS. Established by the UN Economic and Social Council in 1994, UNAIDS is a Joint Program bringing together 11 UN agencies with different mandates, to promote interagency dialogue and cooperation, while mobilising resources and political will. 175 UNAIDS has a more modern governance system than other UN bodies, with civil society members represented on its governing board in a non-voting capacity. 176

Because of the strong normative effect of non-binding instruments, soft rules can also fill gaps and clarify mandates. WHO's PIP Framework (adopted in 2011) governs the ways in which countries are expected to share virus samples to facilitate research, while enhancing equitable sharing of the fruits of that research. 39 As of 2018, WHO is working with states parties of the Nagoya Protocol to the Convention on Biological Diversity (2010) to resolve a mission conflict between the PIP Framework and the Nagoya Protocol. The former is designed to foster global sharing of virus samples, while the latter purports to grant states sovereign ownership of viruses, and naturally, the right not to share. Finding synergies between these two international instruments to enable WHO to develop a legal resolution that fosters the global common good requires good faith negotiations between international institutions representing different interests and governance systems.

Since establishing a supreme dispute-resolution body is a remote, and perhaps undesirable possibility, several actors can work together to reduce fragmentation. WHO and WTO have had ongoing discussions about resolving conflicts in areas such as access to medicines and tobacco control. WHO's IHR formally recognise the importance of international trade. In turn, the WTO has recognised FCTC guidelines as legitimate standards in WTO dispute resolution decisions. 177 The WTO's Agreement on the Application of Sanitary and Phytosanitary Measures explicitly recognises the sanitary and phytosanitary standards of the Codex Alimentarius Commission as the relevant food safety standard-setting entity. 178 Under this commission, WHO and FAO work together. In these examples, and others, international regimes are beginning to recognise and act to harmonise decision-making processes, and, in so doing, improve the public's health.

Challenge 2: weak monitoring, compliance, and enforcement

International law can be an important tool for global health because of its power to create norms that are binding on states parties. However, even though treaties are binding legal instruments, their implementation can be suboptimal because of weak enforcement and inadequate compliance. Typically, international law is built on a foundation of inter-state cooperation and shared responsibility. The norms of international law guide behaviour, but often, treaty oversight bodies have few means by which to compel, or even incentivise, compliance. In extreme circumstances, UN organs can authorise economic sanctions, but these tend to be limited to the arenas of global security, eg, counterterrorism, cybersecurity, and non-proliferation of nuclear weapons. 179 The WTO can also authorise sanctions through its dispute resolution process. 180 The inability to enforce and ensure compliance with international law has stymied the international community's ability to fully use human rights law to prevent or ameliorate gross inequalities.

In global health, the options to incentivise or coerce behaviour in the face of non-compliance are even more limited. 181 The FCTC and IHR—the two major international legal instruments under the direct authority of WHO—have been plagued by incomplete state compliance. 39 This poor compliance has resulted, in part, from external and political forces, and partly from limited technical, legal, and financial capacity.

The IHR seeks to prevent the spread of public health threats from any source (including biological or even radio-nuclear), but primarily aims to prevent the spread of infectious diseases. The IHR covers areas such as state surveillance requirements and obligations to notify WHO regarding potential public health threats of international concern and establishes WHO procedures for when the organisation has been notified. Furthermore, states parties are required to have, or develop, eight minimum core public health capacities to prevent, detect, and respond to specified health hazards: legislation and policy, coordination, surveillance, response, preparedness, risk communication, human resources, and laboratory. 182 Each of these core capacities requires substantial resources and investment from national governments. These activities are largely unsupported by WHO or through other forms of international assistance. 183 Although the IHR encourage international assistance to build capacity in lower-income states, higher-income states—with notable exceptions, such as the US-led Global Health Security Agenda (GHSA)—have largely ignored the treaty's norms of international financial and technical cooperation.

Weak monitoring, assessment, and follow-up capacity can also present a challenge to the effectiveness of international instruments like the IHR. Before 2016, countries were required to self-assess their IHR compliance and competencies. In 2016, WHO worked with the GHSA to introduce a new process and tool, the Joint External Evaluation (JEE). 184 , 185 Under the JEE, independent experts work alongside national officials to ensure transparent reporting. However, JEE is voluntary and some countries remain reluctant to adopt it, in some cases because of concerns about national sovereignty. Furthermore, regarding the points at which JEE does identify gaps in IHR competencies, no comprehensive global mechanism exists to assist low-income countries to finance required reforms. As observed during the Ebola crisis, this absence of a global mechanism presents a potential threat to global security. 39 , 99

Additionally, states could withhold cooperation for political or economic reasons. For example, the IHR require rapid state identification and reporting of novel infections to WHO. However, if states parties do report novel infections they could face travel and trade restrictions or loss of tourism and prestige. Consequently, states might be reluctant to comply in a timely manner with the IHR's reporting obligations. States parties in west Africa were late in reporting Ebola in 2014. When an epidemic did engulf these countries, governments widely ignored WHO recommendations not to impose travel and trade restrictions. Airlines also unilaterally suspended flights to the region. 186

Addressing the challenge of weak treaty compliance

There are creative ways to foster state compliance, even if it is extraordinarily difficult to assure that compliance. Treaty oversight bodies need to work with states and other stakeholders to find innovative ways to promote treaty implementation. This is also true for soft rules, which are often amenable to similar compliance-enhancing incentives and methods. The following are examples of tools that could facilitate compliance, and many already exist in most compliance-enhancing international instruments.

Setting targets and monitoring progress are important tools. Oversight bodies should set clear targets and benchmarks based on norms set in the treaty or soft rule. Having set clear, transparent targets, in collaboration with stakeholders, the oversight body should monitor progress through objective and transparent mechanisms and make its findings publicly available. For instance, WHO's Global Action Plan for the Prevention and Control of Noncommunicable Diseases 2013–20 is supported by a monitoring framework, which includes voluntary targets and indicators. Countries' progress in taking actions to achieve the targets is now also being regularly monitored through the WHO Progress Monitor. 187 , 188

Another tool is state reporting. Both hard law and soft rules could require or encourage states to self-report their progress. Fully transparent reporting is vital, and the oversight authority (such as WHO's Director-General) publicly holds states accountable for abiding, or failing to abide by the relevant norms. For example, the public should know if states fail to rapidly report novel infections as required under the IHR. Greater transparency encourages states to abide by global norms.

Working under a mandate from the UNHRC, UN Special Rapporteurs are independent experts who examine, monitor, advise, and publicly report on human rights from a thematic or country-specific perspective. 189 As of 2018, 43 thematic and 13 country mandates are present. The Special Rapporteur on the Right to Health is Dainius Pūras. Other health-related thematic mandates, for which Special Rapporteurs exist, include access to safe drinking water and sanitation, extreme poverty and human rights, and the right to food.

Treaty monitoring bodies can also receive so-called shadow reports, which supplement the reports provided by states. Shadow reports can come from non-governmental organisations, UN organisations, and academic institutions, and can be presented to all the human rights treaty monitoring bodies, including CEDAW and the Committee on Economic, Social and Cultural Rights, as well as the UNHRC. Because states might not report fairly, completely, or truthfully, shadow reporting provides a mechanism for civil society organisations to provide their own public reports on states' compliance with their treaty obligations.

External evaluations can also be used as tools that could facilitate compliance. As mentioned previously, many states do not have the capacity or political incentives to properly assess their own compliance with global health norms. The majority of states have either not reported or under-reported their compliance with IHR core health system capacities. In the wake of Ebola, several global commissions criticised WHO for failing to ensure more independent assessments. 186 The JEE was developed in response to these criticisms, but, as mentioned above, faces challenges for implementation.

Lower-income states often require financial and technical assistance to comply with treaty obligations. This assistance both incentivises and aids governments in fulfilling their responsibilities. The Global Health Security Agenda (a partnership between nations, international organisations and non-governmental organisations) provides financial and technical assistance in exchange for full cooperation with independent health system preparedness evaluations, which in turn strengthens compliance with the IHR. 190

A further tool that can be used to assist compliance is transparency and public disclosure. State performance can often be hidden, or partially hidden from public scrutiny. Indeed, there is a subtle norm within certain international organisations not to publicly name or criticise member states. Yet, good governance requires openness and public accountability. Civil society and oversight bodies can push for compliance with international health norms by emphasising state actions.

As mentioned in section 1, WHO treaties have weak dispute resolution systems. These treaties could be amended to model more rigorous dispute resolution. Alternatively, WHO should work with states to emphasise the importance of routinely submitting to such resolution mechanisms for the common (public) global good.

The final tool that can be used to assist compliance is private law dispute resolution. As previously described, under the WHO's PIP Framework, parties can be subject to private contracts that are binding, to strengthen compliance with the non-binding PIP Framework. Understandably, many observers will continue to lament the absence of strong enforcement mechanisms in international law. Unfortunately, most international legal obligations are hard to enforce, for example, in relation to human rights, climate change, or arms control. However, the above examples describe ways in which the innovative use of legal and governance tools can enhance compliance with international rules, ultimately strengthening the governance of global health.

Challenge 3: new legal entities, old governance regimes

In the aftermath of World War II, WHO stood unrivalled in the global health space. As of 2019, the same space is occupied by more than 200 international agencies and initiatives. 191 New institutions bring a host of benefits—more funding, an enhanced voice for civil society, and innovative ideas—but also new challenges in leadership, oversight, and accountability. In many cases, old regimes have not fully adapted to the emergence of these new players, raising concerns relating to finding the appropriate level and means of participation by new institutions in governance processes such as those of WHO, and improving the internal governance arrangements of both old and new institutions.

Traditional actors in global health (states and intergovernmental organisations) are governed by established domestic and international legal frameworks. Frameworks originally established many decades ago can fail to take account of new actors and values. Member states, for example, have almost exclusive governance powers under the WHO constitution. By contrast, valuable voices, such as those in civil society, are often not fully heard. Although non-state actors can informally contribute to the Organization's work and attend governing body meetings, they are not permitted to engage in actual decision-making processes. 192 This raises questions of equity, transparency, and accountability. At the same time, although civil society organisations often bring considerable practical and technical expertise, assessing their legitimacy or their sources of finance can be difficult.

As reported by the Lancet -Oslo Commission, global health is characterised by imbalances in political power, leading to inequities in health. 4 Powerful, entrenched actors might influence international institutions to advance their private interests, rather than the health of the public. For example, civil society has criticised WTO for diminishing access to essential medicines in favour of private commercial interests in intellectual property (eg, patent protection for pharmaceuticals). 193

WHO itself suffers from so-called capture by its powerful member states and non-state actors, who fund almost 80% of its annual operating budget. 194 The Gates Foundation has considerable influence on WHO's agenda. At the same time, WHO has been struggling to find an appropriate way to engage with the private sector. Health and human rights advocates have expressed concern about an overly close relationship between WHO and vested corporate interests.

Although WHO and other post-World War II intergovernmental agencies often have clear governance arrangements, oversight of new players and new legal entities (eg, civil society organisations, foundations, and PPPs) presents a greater challenge. Large PPPs often have limited transparency and accountability because of participation of private actors. 195 At the national level, private entities such as corporations and charitable foundations are subject to government oversight, especially to protect private shareholders and the general public. 196 However, no single state can fully control the activities of large, transnational corporations that operate in multiple countries and regions. States' oversight of major non-profits such as the Gates Foundation is also inadequate.

This limited transparency can pose governance concerns: some PPPs have been criticised as vehicles for market penetration (increasing a product's market share through strategies such as bundling, advertising, lower prices, or volume discounts), or as a means for private actors to wield influence over international law-making and policy-making processes. 197 In the fast-changing arena of global health, the potential efficiency of newer actors should not be traded against “good governance, transparency, participation and engagement; clear accountability for success and failure; coordination and coherence; and a new eye on priority setting to achieve ambitious global goals while balancing equity and efficiency”. 105 Good governance should both facilitate efficiency, while still ensuring effective oversight and accountability.

Addressing the challenge of new and old governance regimes

To some extent, governance regimes are evolving in response to these new players. In 2016, WHO member states negotiated a Framework for Engagement with Non-State Actors, 192 which includes non-governmental organisations, private sector entities, philanthropic foundations, and academic institutions. The Framework guides and strengthens the ways in which WHO interacts and works with these entities, seeking to ensure “transparency, openness, inclusiveness, accountability, integrity and mutual respect”, while “protecting its work from potential risks such as conflict of interest, reputational risks, and undue influence”. 192 The Framework could assist WHO to strike a better balance between active engagement with outside actors, and maintaining the integrity of its own governance arrangements. Yet, many in civil society continue to campaign for more participatory decision making.

Overcoming the problem of limited participation in WHO governance will require innovative thinking. The WHO's Executive Board has granted a small number of non-governmental organisations, international business associations, and philanthropic foundations an official relations status on the basis that they “have a sustained and systematic engagement in the interest of the Organization…and contribute significantly to the advancement of public health”. 192 This criteria has excluded smaller non-governmental organisations working in the health space, separating them from WHO. The Organization should find a way to better harness the creativity and energy of civil society organisations.

Innovative governance arrangements in newer entities could help improve inclusiveness and transparency. For example, The Global Fund has implemented innovative governance for greater civil society participation, described as follows. 7 The first implementation was non-governmental organisation representation—including from developed and developing countries, as well as from communities living with the Fund's targeted diseases—on its Board, alongside representatives of the private sector, national governments, and philanthropies. Additionally, local, multi-sector, multi-stakeholder committees, known as Country Coordinating Mechanisms (CCMs) were introduced to oversee grant implementation at the local level. CCMs must include members of communities living with the Fund's target diseases and must document the involvement of marginalised or vulnerable populations in their work. The Global Fund has also adopted standards to manage conflicts of interest with CCMs. 198 Dual-track financing, whereby the CCMs nominate both a governmental and non-governmental principal recipient for financing was introduced; 198 and finally, community systems strengthening through activities such as partnerships, capacity building, service delivery, as well as planning, monitoring, and evaluation.

The Global Polio Eradication Initiative is another example of a PPP that has adopted innovative governance arrangements to foster greater transparency. The Initiative—a partnership between WHO, Rotary International, the US Centers for Disease Control and Prevention, UNICEF, and the Gates Foundation—is overseen by an Independent Monitoring Board of global experts. The Board evaluates the Initiative's work against key milestones. If milestones are deemed to be at risk, off track, or missed, the Board reports to the partners, and makes its reports public. 199

Independent and civil society voices are crucial for holding global health actors accountable. Arrangements such as these provide legal and governance mechanisms for those voices to be heard, leading to more robust processes, and ultimately, outcomes that achieve health with justice.

Legal reforms could greatly enhance the governance of global health

Law can shape the governance of global health in various ways. Law defines the mandates, powers, and structures of, and the interactions between, key players in global health. However, the potential to deliver health with justice is weakened by multiple governance challenges: fragmentation and overlap, poor compliance and enforcement, and disjunctions between actors with great influence over global health and the regimes intended to govern them. In this section, we have built on the work of the Lancet -Oslo Commission, specifically identifying ways in which law could strengthen good governance for global health. We have identified measures to harmonise institutional mandates, mechanisms for review of decisions, forums for ensuring international policy coherence on health, and innovative compliance-enhancing arrangements. In each of these ways, law can address vital governance challenges in global health. Specifically, recommendation 3 proposes that the UN set good governance standards for UN specialised agencies and programmes, including WHO. This proposal is supported at the national level by recommendation 4, which states that governments should develop legal frameworks establishing principles of good governance throughout national health systems and policy making.

Section 4: legal determinant 3

Law can be used to implement fair, evidence-based health interventions, and can be a powerful tool for global health. 3 Statutes and regulations can be used to implement interventions that lower the exposure to risk factors across entire populations. As a result, law has been integral to many of the great public health successes of the past century, including motor vehicle safety, tobacco control, infectious diseases control, a safer food supply, workplace safety, and childhood vaccinations. 200 Many public health interventions require enactment and enforcement of laws and regulations, such as taxes on tobacco, alcohol, or sugar-sweetened beverages; marketing or sponsorship bans; and minimum age of purchase requirements. In other cases, laws facilitate effective health interventions, such as immunisation requirements for school entry or creation of safe injection sites for drug users.

However, law is only a tool. When used without sufficient evidence, or without regard for justice and human rights, statutes and regulations may be ineffective—or worse, could undermine health. Law could also perpetuate injustice, such as by establishing a multi-tier UHC health insurance system that provides real benefit to some people (eg, civil servants, formal sector employers) but only limited benefits to others (eg, informal sector workers). Our third legal determinant of health is the effective, fair, and evidence-based enactment and implementation of legal interventions.

In this section, we first offer a framework for evaluating health laws, and propose four characteristics of effective laws that advance health with justice. We then provide key examples of effective laws, across three risk factor domains: infectious diseases, non-communicable diseases, and injuries. In each domain, we describe ways in which international and domestic laws interrelate and inform one another. Sharing of experiences and research regarding the effectiveness of public health laws among jurisdictions, and with international organisations, will be crucial to the global dissemination of just, evidence-based legal interventions. Finally, we explain how laws that are not informed by evidence and human rights principles could undermine health, while entrenching inequality and discrimination.

Evaluating health laws: does this intervention advance health with justice?

The Commission concluded that across the spectrum of global health hazards, legal interventions will be most effective when they are based on sound science, and guided by the values of justice, transparency, and inclusion. The most just and effective public health laws share the following four core characteristics: they are evidence based, equity promoting, multisectoral, and supported by good governance ( figure 4 ). Laws that share all these characteristics will best advance health with justice.

Core characteristics of legal interventions that advance health with justice

Health laws must be evidence-based

Sound scientific evidence is the most important characteristic of effective public health laws. 201 Laws should be informed by scientific evidence, rigorously answering the question: do they improve the health and safety of the population, while not posing undue burdens on individual rights? Although we emphasise the important role of innovation and well considered novel approaches in public health law and regulation, this should always be implemented in conjunction with well designed evidence gathering and rapid evaluation. In section 5, we suggest ways to expand and strengthen the evidence base for, and the legal capacity to, implement legal interventions.

Policy makers sometimes—perhaps often—must act on incomplete evidence or scientific uncertainty. A classic example of the need to act without complete information is when a major health hazard or emerging health risk demands an urgent response, and perhaps an innovative approach. For example, the Democratic Republic of Congo deployed investigational new vaccines and therapies in response to Ebola in 2018–19, even though regulatory agencies had not yet found the vaccine and drugs to be safe and effective.

The absence of full information to thwart legal innovations should not be allowed. If policy makers always had to wait for an exhaustive research study, many substantial threats to the public's health would persist. Evidence might come from analogy to other areas of law, such as the effectiveness of taxes on reducing sugary beverages, based on effectiveness of taxes in reducing tobacco use. Similarly, evidence of effectiveness for portion controls on sugary beverages might come from studies showing increased portion size, and its relationship to overweight or obesity. In such cases, policy makers need to make informed choices for law reform, in the absence of complete evidence.

While using the best available (albeit incomplete) evidence at the time, evaluating the law's effect to ensure continuous quality improvement in health legislation is imperative. Even then, though, law makers might need to accept some uncertainty, such as where there is clear evidence that a suite of legal measures is effective at addressing a complex health threat (eg, obesity, or gun violence), but it is difficult to determine the specific contribution of any single intervention. For example, in tobacco control, a comprehensive approach using a host of demand and supply reduction measures has, in combination, substantially reduced smoking rates over time.

Health laws must promote equity

Poor and disadvantaged communities often have a disproportionate burden of morbidity and premature mortality, as well as the social and economic consequences of disease and injury. These populations include people with mental or physical disabilities; racial, ethnic, or sexual minorities; and women and children. Poor health outcomes, in turn, further entrench disadvantage. Poor and marginalised populations—whether living in low-income and middle-income countries, or in wealthier countries—often live, work, recreate, travel, and go to school in unsafe or unhealthy environments. They also benefit less from prevention services and have less access to high-quality treatment and rehabilitation services. 202 Interventions that target inequalities are thus fundamentally linked to those that address ill health. 203

Achieving health with justice requires non-discrimination; equitable distribution of benefits and resources within and across communities, within countries, and globally; and protecting underserved communities. At a national level, law makers should pay particular attention to the needs of the poorest, the most vulnerable, and those who are marginalised. At the global level, it is important to translate international norms to the national and local levels to reduce health disparities among and within states. If the world is to achieve the SDG's pledge of “leaving no one behind”, public health laws must target areas of deep inequity.

Health laws must engage sectors beyond health

Laws far beyond the health sector influence the conditions for achieving population health and reducing inequalities. The criminal justice system, taxes and transfers, urban planning and development, trade, agriculture, housing, and the environment are incidental to, but deeply affect population health. 10 If not conceived with due consideration for health objectives, laws in these sectors could have powerful adverse effects on health. For example, agricultural subsidies for corn, sugar, or meat can exacerbate major health and environmental threats.

Conversely, multiple sectors have the potential to improve population health and justice. Urban planning, education, social services and other portfolios can have major health-enhancing features. Yet, public health researchers and officials often neglect agencies outside of health ministries. Achieving health with justice requires an all-of-government approach, supported by the head of government.

Health Impact Assessments (HIAs) measure the health effects of proposed initiatives in diverse sectors (criminal justice, education, housing, nutrition, education, and revenue) using quantitative, qualitative, and participatory techniques, with particular regard for health equity. HIAs adopt an all-of-government or health-in-all-policies (healthy policies) approach to governance. HIAs dynamically improve health and wellbeing across sectors. Several countries and sub-national jurisdictions, such as Thailand, Slovakia, and several US states, have laws requiring HIAs for policies substantially affecting public health or for policies or programmes in certain sectors. Other laws empower public health authorities, or even the public, to request an HIA, 204 as evidence shows that HIAs can have a substantial positive effect on public policy. 205 , 206

In 2008, the WHO Commission on the Social Determinants of Health recognised the importance of reform in multiple sectors. Despite this, international institutions (including WHO itself) and governments have not devoted the attention and resources needed to address the social determinants of health. We argue that law can be highly effective in defining and operationalising government action. By creating and implementing social norms and redistributing resources, law can create the conditions for the public's health. Examples of the power of law to affect the social determinants of health include social welfare and income support programmes; market regulations that enhance income and agency for workers (minimum wages, paid sick leave or family leave); protection of union and labour rights; redistribution policies, such as pre-tax limits on compensation levels, progressive taxation, and negative income taxes; nutrition policies, such as subsidising healthy foods and restricting unhealthy foods in school lunches; consumer protection; and occupational health and safety regulations.

Health laws must be supported by good governance

Finally, health with justice can only be delivered against a backdrop of good governance, sound regulatory principles, and the rule of law. These include transparency and openness; civil society or community engagement and inclusive participation; monitoring and evaluation systems; honesty, non-corruption, and stewardship; and accountability at all levels, from legislating, through implementation, to enforcement. We have addressed these concepts in detail elsewhere in this report, in sections 3 and 5.

Effective legal interventions

Despite past successes, law remains underutilised as a tool for population health. 207 In this section, we discuss legal and regulatory interventions across three broad health domains: infectious diseases, non-communicable diseases, and injuries. These interventions have been effective because they share the characteristics previously discussed. For each, we provide key illustrations, complementing the other examples and case studies found throughout this report. A comprehensive list of domains and interventions from around the world can be found in the report from WHO, International Development Law Organization, O'Neill Institute, Sydney University: Advancing the right to health—the vital role of law. 86

In keeping with our global health lens, we also focus on the ways in which national and global health law intertwine, showing the potentially far-reaching effects of law. Legal interventions that successfully advance health with justice at the local and national levels have been adopted (and adapted) in other jurisdictions, as well as translated into international norms. At the same time, international norms have been codified in national and local laws. This interaction shows the multidimensional nature of creating and diffusing highly effective health laws from the global level to the local and national levels, and vice versa ( figure 1 ).

Infectious diseases

During the 20th century, improvements in sanitation and hygiene, vector abatement, and surveillance ushered in substantial advances in infectious disease control. 208 Previously devastating infections are now treatable, even as the global health community wrestles with the frightening prospect of antimicrobial resistance. The advent of vaccination laws vastly reduced deadly childhood diseases such as measles, mumps, and rubella. Smallpox was a major killer before mass immunisation led to its eradication. Before the Salk vaccine, people feared the paralysing effects of polio. WHO, along with international partners, is now aiming to eliminate polio around the world.

Throughout modern history, law has played a major role in reducing infectious diseases through national public health laws and regulatory frameworks, international legal agreements, and governance reforms. As of 2019, the international community faces new challenges and must undertake health system and animal husbandry reforms, while also incentivising development of new medicines to combat antimicrobial resistance.

National legal frameworks in the form of laws and regulations give public health agencies wide-ranging powers to control infectious diseases. These regulations include powers to identify individuals (testing) or populations (screening) who can potentially transmit infections; require health providers and others to notify public health agencies of cases of infectious disease; trace contacts of infected individuals or notify partners; vaccinate exposed persons, their contacts, and broader populations; directly observe individuals to ensure they take the full course of their medications such as directly observed therapy for tuberculosis; and separate people who are infected (isolation) or have been exposed (quarantine) from healthy populations. Law can also require rigorous community and hospital infection control, such as disinfection, hand hygiene, and personal protective equipment. It can limit animal–human interchange to prevent pathogens jumping from animals to humans ( table ). When public health officials exercise compulsory powers, they should provide due process or natural justice, such as a fair hearing. Procedural safeguards are often necessary to prevent health officials from acting in an arbitrary or discriminatory manner.

National public health laws to control infectious diseases

In addition to the IHR and PIP Framework, which relate to human pandemic illness, countries should prepare for, and evaluate preparedness for, zoonotic diseases (animal diseases that can be transmitted to humans). Even diseases that infect only animals can damage economies by curtailing meat exports, or driving up domestic food prices. As of April, 2017, only six countries worldwide had undergone two external evaluations of their ability to withstand a global pandemic. One evaluation is for human diseases (the JEE, in cooperation with WHO) and the other relates to animal diseases (in cooperation with the World Organization for Animal Health). 209 , 210

Law can also be used to help limit the spread of organisms that are resistant to antimicrobial medications. For example, regulation can operate to better ensure appropriate prescribing of antimicrobials. Law can also be used to ban the prophylactic use of antibiotics in animal populations or to promote growth, thus reducing the reservoir of drug resistant organisms in farmed animals. Similarly, regulations can require surveillance of drug resistant infections in both human and animal populations.

Law plays a particularly important role in limiting the manufacture of, and trade in, falsified and substandard medicines. When patients take antimicrobials that have sub-optimal doses of active pharmaceutical ingredients, they can develop drug resistant infections. Countries should update legislation to provide clarity on what qualifies as falsified and substandard medicines according to the definitions that the WHA approved in 2017, 211 strengthen criminal penalties to deter manufacture and sale of these products, ensure adequate registration and quality surveillance systems, and sufficiently resource public health regulatory and customs agencies for increased surveillance and enforcement. Legislation could require that pharmacists are trained in detecting falsified and substandard medicines. The WHA should adopt a code of practice on falsified and substandard medicines that sets standards on surveillance and international reporting and provides guidelines for and coordinates regulation and law enforcement. 212

Because infectious diseases do not respect national borders, global health law and governance are just as important as national legislation. WHO has adopted two major legal instruments to safeguard global health security, but both face major problems, as does WHO governance itself.

The 2014–15 Ebola virus epidemic in west Africa revealed “deep inadequacies in the national and international institutions responsible for protecting the public from the far-reaching human, social, economic, and political consequences of infectious disease outbreaks.” 99 A review of four global commissions in the wake of the epidemic drew together recommendations and suggested reforms for future global health pandemic preparedness. 186 Many proposed reforms involved law and regulation, including surveillance, disease notification, infection control, and strengthening national health systems. Good governance for health was another major aspect of the required reforms, both at the national and global levels—for example, transparency, monitoring, risk communication, community engagement, and accountability.

Crucial to this last function is strengthening and scaling up WHO's IHR and PIP Framework, and building capacity at WHO itself. 39 Implementation of the IHR during the Ebola epidemic was deeply flawed: WHO delayed its declaration of a Public Health Emergency of International Concern (PHEIC) for over 4 months after the first international spread. 213 Declaration of a PHEIC under the IHR carries normative weight under international law, and allows WHO to alert and engage the international community. 214 At the same time, only 30% of states parties had reported meeting the IHR requirements to develop core health system capacities, 215 and states widely ignored WHO travel recommendations. During the Ebola epidemic, the PIP Framework was not even applicable, as its narrow scope is limited to pandemic influenza strains.

The post-Ebola commission reports urged research and development of vaccines and anti-microbial medications to be better funded and expedited. Yet, regulatory frameworks such as intellectual property, so-called ownership of viruses, inconsistent regulatory approval pathways, legal liability for pharmaceutical companies, and divergent clinical trial standards can hinder rapid development of medical technologies to respond to public health emergencies. These regulatory frameworks need to be reformed, or made more flexible, to support the development, procurement, approval, and deployment of effective therapeutic countermeasures. Legal obstacles to the effective deployment of countermeasures should be addressed and resolved in advance of future pandemics.

The law can also offer a protective function, helping to ensure that patients and human participants in research are treated with dignity and respect, while safeguarding them against unethical research and unsafe products. Liability reform can incentivise manufacturers to more rapidly develop and deploy products. Additionally, the formation of multi-disciplinary partnerships that include patients, health care providers, experts, industry partners, ethicists, lawyers, and others would promote a clearer understanding of regulatory rules and ethical practices, as well as better sharing of research information.

Despite considerable progress, the burden of infectious diseases remains unacceptably high, particularly in low-income and middle-income countries, and among poor and rural populations. 3 Each year, millions of people die from diseases such as HIV and AIDS, tuberculosis, malaria, hepatitis, influenza, and neglected tropical diseases (although WHO is making substantial progress in controlling negative tropical diseases). 119 The unprecedented movement of people and goods around the globe is amplifying the spread of infectious diseases, as is climate change. 216 , 217 In settings where health systems are weak, populations are all the more vulnerable to emerging or re-emerging infectious diseases. Since 2000, the world has experienced major outbreaks of novel infections such as Severe Acute Respiratory Syndrome, Middle East Respiratory Syndrome, new strains of pandemic Influenza (H1N1), Ebola, and ongoing Zika virus transmission. 186 Outbreaks of cholera, plague, and yellow fever have caused considerable illness and death.

Infectious disease laws are crucially important, but must respect human rights, promote equity, and reflect international norms such as the Siracusa Principles.

Non-communicable diseases

WHO estimates that non-communicable diseases cause 40 million deaths annually, amounting to 70% of all deaths globally. 218 People die too young from these diseases, with negative consequences on productivity and socioeconomic development. In 2015, 16·9 million deaths were estimated to occur before age 70 years and 9·2 million before age 60 years. Moreover, the huge toll of death and disability from non-communicable diseases does not affect all populations equally; 31 million (or three quarters of the total) of global non-communicable disease deaths occur in low-income and middle-income countries. The main non-communicable diseases—cardiovascular diseases, cancer, chronic respiratory diseases, and diabetes mellitus—share four main behavioural risk factors: tobacco use, physical inactivity, the harmful use of alcohol, and unhealthy diets. 160 Evidence shows that social and economic circumstances can significantly increase the risk of non-communicable diseases. 219

An increasingly strong evidence base exists regarding how population-level interventions can be used to prevent and control non-communicable diseases. WHO's Global Action Plan for the prevention and control of non-communicable diseases 2013–20, including the updated appendix 3 , represents the most important normative instrument on non-communicable diseases at the global level. 160 Many of its policy recommendations, some of which are so-called best buys for public health (highly cost-effective, evidence-based interventions), include the use of law and regulation ( panel 6 ). Building on the strong evidence of success in Denmark, New York City and other settings, WHO now recommends that countries use legislation to eliminate industrial trans fats in the food supply.

Tobacco control is important in containing the spread of non-communicable diseases. WHO's non-communicable diseases Global Action Plan incorporates the FCTC's provisions in its recommended actions. Updated appendix 3 calls on states parties to “strengthen the effective implementation of the WHO FCTC and its protocols”, including by establishing “national mechanisms for coordination of the WHO FCTC implementation as part of national strategy with specific mandate, responsibilities and resources”. 160 The action plan also invites member states that are not parties to the FCTC to “consider implementing the measures set out in the WHO FCTC and its protocols, as the foundational instrument in global tobacco control”. 160

The FCTC provides a prime example of the inter-relationship between international and domestic law, providing a precedent for future global health governance. The WHA in 1995 urged member states that had already successfully implemented all or most of a comprehensive strategy for tobacco control to provide assistance to WHO. 220 This aid would allow WHO to provide advice and support to other member states seeking to improve their tobacco control strategies. The following year, the WHA voted to begin work on developing a framework convention. A decade later, the FCTC entered into force. 221

The FCTC has had a substantial effect on global tobacco control, with its norms widely implemented at national and local levels. Particularly in high-income countries, a so-called suite of national and local laws and regulations has resulted in large declines in tobacco use. A combination of legal interventions all operate to reduce smoking in youth and adults, including lowering the legal age for buying tobacco products, marketing bans or restrictions, bans on smoking in public places, high taxation, and graphic packet warnings. For example, 111 of 181 FCTC states parties require pictorial warnings on cigarette packages, as recommended under Article 11. 222 Governments are now implementing major so-called endgame strategies, such as gradually increasing the legal smoking age, and vast reductions in the nicotine levels in cigarettes, which addict virtually all smokers. 223

However, the FCTC faces substantial compliance challenges, particularly in low-income and middle-income countries. For instance, Article 14 encourages countries to put in place tobacco cessation infrastructure but does not provide the resources to allow low-income and middle-income countries to do so. As of 2013, only a minority of countries had in place the infrastructure necessary to offer cessation support to tobacco users. 224 Furthermore, compliance and enforcement challenges are only made more difficult in the presence of aggressive opposition from vested commercial interests. 225 Ongoing monitoring, and strategies to strengthen the capacity of states to comply with their FCTC obligations, are two important ways to bolster the effect of this instrument.

Dietary salt reduction provides another good illustration of countries incorporating WHO guidance on non-communicable disease prevention, fitting global norms into their social, political, and regulatory contexts. High salt intake is estimated to be associated with nearly half of the disease burden ascribed to hypertension, a major contributor to global morbidity and mortality. 226 , 227 , 228 The physiological requirement for salt is less than 1 gram per day, 229 and WHO recommends less than 5 grams per day for adults. 230 Yet, in 2010, the global mean salt intake was twice this level, or 10 grams per person per day. 231 WHO's Global Action Plan has set a target of a 30% reduction of population-level salt intake by 2025. 232

Population salt reduction is among WHO's so-called best-buys to reduce chronic disease—an intervention that could lead to substantial health benefits as well as cost savings. 233 , 234 In the USA, it has been estimated that a regulatory intervention designed to achieve a reduction in salt intake of 3 grams per day would save 194 000 to 392 000 quality-adjusted life-years and US$10–24 billion in health-care costs annually, and would be more cost-effective than using medications to lower blood pressure in all people with hypertension. 235 From a population perspective, the most effective and equitable means of reducing salt consumption is to reduce the salt content of manufactured foods. 236 , 237 In many countries, processed foods substantially contribute to salt intake, 238 regardless of any action individuals might take to reduce the salt they add to food.

Countries are adopting population-level salt reduction strategies to achieve WHO's 30% reduction target by 2025. Many of these focus on reductions at the manufacturing level (reformulation), complemented by public information campaigns and nutrition labelling. The strategies also use diverse regulatory forms. In 2006, the UK became the first country to set salt targets for food composition. Using a voluntary approach, but with strong government leadership and oversight, UK manufacturers agreed to progressive reduction targets for around 80 categories of processed foods. Their reformulation efforts were supported by consumer education and improved food labelling. The approach was highly successful, resulting in a 15% decrease in salt intake across the population. 239 South Africa was the first country to set legislatively mandated salt reduction requirements across a wide range of processed foods. In March 2013, the South African Minister of Health issued the Regulations Relating to the Reduction of Sodium in Certain Foodstuffs and Related Matters. 240 The requirements took effect on June 30, 2016, with more stringent maximum levels coming into force on June 30, 2019. 240 Argentina has used a combination of voluntary and mandatory salt reduction techniques. Initially, the Ministry of Health and large food companies signed a voluntary agreement in 2011 to gradually and progressively reduce sodium in processed foods. 241 Voluntary targets were set according to the category of food, with reductions ranging between 5–18% over a 2-year period, and a government campaign supporting and encouraging behaviour change. In 2013, to build on the success achieved through the voluntary scheme, Argentina enacted a national law regulating the sodium content of processed foods. As of 2019, 83 countries have salt reduction strategies in place or planned, including 35 countries with voluntary targets and nine with mandatory, legislated targets. Almost all countries use a multifaceted regulatory approach, with 70 counties implementing, or planning to implement more than one type of strategy, and 33 countries incorporating legislative initiatives such as taxes, maximum limits, or warning labels. 242 Programmes are now being implemented in countries across all WHO regions and across countries with a broad range of income levels. 242 An example of these changes is described in the case study of the regulation of sugar-sweetened beverages ( panel 7 ).

Regulation of sugar-sweetened beverages

Sugar-sweetened beverages (SSBs), generally defined as liquids with added sugars (soft drinks, sports beverages, energy drinks, sweetened waters) are a known contributor to a variety of non-communicable diseases such as obesity, type 2 diabetes, heart disease, kidney disease, non-alcoholic liver disease, tooth decay and cavities, and gout. 243 In response to the non-communicable disease epidemic, countries have begun to regulate SSBs, primarily through excise taxes, which add a per ounce fee to the SSB sales price, although traditional sales taxes have sometimes been employed. 244 , 245 The trend toward taxation has increased substantially over the past decade, and particularly during the past 5 years. As of 2019, more than a dozen countries, including France, the UK, Norway, Portugal, Chile, Saudi Arabia, South Africa, Thailand, and Mexico, along with numerous localities, have adopted sugar taxes of varying scope and size. 246

Two of the most studied tax cases were in Mexico and Berkeley, California. Mexico was among the first countries to implement a substantial tax on SSBs, in 2014, levying a 10% excise tax on all SSBs except milk. Researchers found an immediate reduction in SSB consumption during the following years, with sales of SSBs falling by 5·3% in 2014 and 9·7% in 2015, while sales of untaxed beverages increased in 2014 and fell by only 1% in 2015. 247 In Berkeley, which adopted a 1 cent per ounce tax on SSBs, researchers found that SSB sales decreased by 9·6% while untaxed beverage sales increased by 3·5%, driven primarily by a 15·6% increase in sales of bottled water. 248 Importantly, the tax did not seem to meaningfully affect overall consumer shopping habits, as average grocery bills did not increase, and Berkeley store revenue did not decrease compared with control cities. Multiple studies (in addition to those in Mexico and Berkeley) found that SSB taxes lead to moderate reductions in consumption, which could support positive downstream health outcomes. 249

WHO supports adoption of SSB taxes as a strategy to help combat non-communicable diseases, particularly obesity and diabetes, citing evidence that an SSB tax that increases consumer prices by 20% can lead to an approximate 20% reduction in consumption. 249 Crucially, researchers have cautioned that SSB taxes must be relatively high to reduce consumption; at lower levels retailers could elect to absorb the cost of the tax in order to retain customer business, particularly if customers are readily able to purchase comparable goods from a nearby retailer in a location without such a tax. 250

Supporters of SSB taxes often argue that improved population health resulting from SSB taxes will eventually reduce health-care costs. WHO cites estimates that, over 10 years, a tax on sugary drinks of 1 cent per ounce in the USA would result in more than US$17 billion in health-care cost savings. 249 Supporters argue that the revenue generated by SSB taxes can offset health-care expenses. For example, WHO cites estimates that an SSB tax of ¥1 (US$0·16) per litre in China would generate an estimated ¥73·6 billion (US$11·8 billion) in revenue. 249

As policy makers have become more interested in taxation and other regulation of SSBs, so too has the beverage industry, adopting creative techniques to forestall new regulation. For example, in response to local efforts to implement SSB taxes within California (the largest state in the USA, with over 39 million residents), the beverage industry engaged in an aggressive and ultimately successful strategy to preempt local taxation authority. In California, the generally liberal state government would normally be unlikely to adopt a state wide ban on new soda taxes. However, in 2018, the beverage industry deployed a two-pronged effort to curb local SSB taxing authority, first, by financing a ballot initiative in support of a sweeping preemptive tax law 251 , 252 that would have been devastating to localities, and later, by agreeing to withdraw the proposed initiative if a more narrow food and beverage tax ban bill passed, a move that was characterised by some legislators as “blackmail” and “being held hostage”. 253

The industry's forceful techniques were effective. In June, 2018, the California legislature passed a bill preempting any new local food or beverage taxes for 12 years, 254 joining Michigan and Arizona in adopting state wide bans on new soda taxes. Several other states in the USA have considered such bills, and the industry appears likely to continue to lobby in support of their passage in the USA and globally.

The California example is emblematic of the challenges facing policy makers and health advocates. Although research shows that SSB taxes are an effective legal tool to help combat the non-communicable disease epidemic, the industry has mobilised to defeat any important new regulation. With industry willing to spend heavily in support of its objectives, public health advocates must be prepared for a more difficult path toward adoption of future SSB taxes.

Physical inactivity is the fourth leading risk factor for global mortality and was associated with an estimated 55·3 million deaths globally in 2008. 255 , 256 A European prospective investigation of over 334 000 men and women found that twice as many deaths could be attributed to lack of physical activity, compared with the number of deaths attributable to obesity. Even a modest increase in physical activity could have significant health benefits: a brisk 20 minute walk each day could be enough to reduce an individual's risk of early death. 257 WHO recommendations go further, recommending that adults undertake 150 minutes of moderate-intensity physical activity, or 75 minutes of vigorous-intensity physical activity, throughout the week. 258 Building on these findings and recommendations, an emerging body of evidence on legal and regulatory interventions is aimed at increasing physical activity.

Features of the built environment, including the so-called walkability of a city, are strongly associated with the prevalence of obesity. A gender equity dimension is also present, as women tend to be further disadvantaged in their opportunities for physical activity where cities are not walkable. 259 This is another area in which laws and regulations that affect population health might lie well outside the usual reach of health ministries, thus requiring intersectoral cooperation. In a 2009 review of the evidence, WHO found that modifying the built environment, policies that reduce barriers to physical activity (such as walking, biking, and recreation), transport policies, and increased space for recreational activity were all effective interventions. 260

Examples of effective laws and regulations to increase physical activity include urban planning, land use management and zoning, transport policy (including taxes on car use, availability and accessibility of public transport, and bicycle and walking paths), and road and traffic control. 261 Local governments can play an important role because land use and zoning frequently fall under their remit. Local governments can implement building, zoning, and development regulations that encourage more physically active lifestyles: streets that are welcoming and safe for pedestrians and cyclists, facilities for public recreation (parks and playgrounds), and traffic calming measures. 15

The common theme among legal and regulatory interventions to prevent non-communicable diseases is that they promote small changes, across entire populations, for a mass impact. By simply changing a default option (eg, reducing salt in processed food, forbidding smoking in certain areas, or making public transport easier than car use), law has the power to facilitate profound changes in behaviour. Good laws can make healthier and safer behaviours the easier or normal choice. In conjunction with health promotion and awareness campaigns, countries can use law to support and encourage communities to resolve the problems arising from the shared risk factors of non-communicable diseases.

WHO estimates that more than 5 million people (equivalent to 9% of global mortality) die each year as a result of injuries, and many more endure temporary or permanent disability, along with great social and economic hardship. 262 Leading causes of injuries include road traffic crashes, drowning, poisoning, falls, burns, and violence. 262 Again, the burden falls disproportionately on the poor, and more than 90% of injury-related deaths occur in low-income and middle-income countries. Unsafe workplaces or dwellings expose people to high levels of injury risk: prominent incidents include the 2012 Tazreen Fashion factory fire on the outskirts of Dhaka, Bangladesh, and the 2017 Grenfell Tower fire in London, UK. In both episodes, fire safety laws were substandard, poorly enforced, or both. In lower-income countries, countless women sustain debilitating injuries or death from unsafe cooking stoves. Around the world, injuries from the mining and extractive industries disproportionately affect men, and young men bear a disproportionate burden of motor vehicle injuries. Yet, a strong evidence base exists for legal interventions in injury prevention, with road safety being the most prominent example.

The UN General Assembly declared 2011–20 as the Decade of Action for Global Road Safety, 263 and road safety is integrated into SDGs 3 and 11. Each year, 1·24 million people die as a result of road traffic injuries, and a further 20 million to 50 million sustain non-fatal injuries. 263 Road traffic injuries are the leading cause of death among people aged 15–29 years. 264 , 265 Evidence shows that legislating on five key behavioural risk factors—speeding, drink driving, helmet use, seat belt use, and child restraint use—could significantly reduce this toll. 266 The regulation of environmental and design factors, such as safer vehicles and roads, has also proved highly effective in preventing road crashes. Such interventions include energy-absorbing crumple zones on cars, passive restraints, visible roads with clear lane markings, traffic separation (eg, oncoming vehicles or bicyclists), and traffic calming (eg, roundabouts and speed bumps). However, few countries have systematically implemented laws that target behavioural risk factors and design features, or laws that implement best practices. In particular, low-income and middle-income countries often have substandard laws, and poor compliance and enforcement. 267

Global health institutions can establish norms that promote the uptake of such laws. Efforts to define technical standards for safety and to conduct policy surveillance of national road safety laws can be effective in helping to spread better laws. For example, seatbelts are a proven way to reduce road traffic injuries and have been mandatory in northern Europe and the USA since the 1970s. 268 , 269 In 2004, the WHA adopted resolution WHA57.10, recommending that member states implement mandatory seatbelt laws. The following year, the UN General Assembly adopted its own resolution, A/60/5, similarly calling for mandatory seatbelt legislation. Since then, there has been a significant increase in the number of states that have legislated for national mandatory seatbelt use. 270 Botswana, Cuba, and Kyrgyzstan had a notable drop in road fatalities after mandating seatbelt use for all vehicle occupants.

Wearing helmets can substantially reduce road traffic injuries, and laws mandating helmets for motorcycle drivers and passengers are making an impact around the world. The UK and many US states have had such laws in place since the late 1960s and early 1970s; however, many states in the USA have since repealed their helmet laws, which has significantly increased head injuries. Helmet laws have been proven to be highly effective, reducing the risk of head injuries by 69% and the risk of death by 37%. 271 In 1997, Taiwan introduced legislation making it compulsory to wear a motorcycle helmet. The government supported this legislation with, on one hand, a public information campaign, and on the other, strict fines for both riders and passengers. 272 The results have been powerful: between 1991 and 2008, motorcycle-related deaths almost halved (from 7322 to 3646), despite an increase in both motorcycle use and crashes during the same period. In 2007, Vietnam introduced a similar law, 273 supported by large fines for non-compliance. The Ministry of Health in Vietnam and WHO reported that road traffic head injuries and deaths had decreased by 16% and 18%, respectively, 3 years after the law was introduced. 274

When laws do not advance health with justice

When used effectively, law can be the foundation for sustainable, transformational social change. However, when used inappropriately, law can cause grievous harm—sanctioning discrimination and inequality, imposing barriers to access, creating intentional obfuscation, and increasing complexity. As we have reiterated throughout this report, law is only a tool, and its effectiveness depends on how this tool is used. Emphasising the risks that arise when laws do not have the characteristics set out above is important.

The criminal justice system has had a particularly tenuous relationship with public health. Criminal laws can provide a powerful incentive for behaviour change that improves public health, as in the case of road safety. However, too often, the criminal law is used in ways that cause harm to health and to dignity. The history of laws relating to mental health, substance abuse, sexual and reproductive health, sexually transmitted infections, and poverty are often particularly harmful.

Even with an ostensible public health objective, laws can institutionalise inequality, discriminate against already vulnerable populations, and remove opportunities for stigmatised populations to access testing and treatment. We see this most often where criminal laws are enacted to promote a moral norm, rather than to punish a harmful act. For example, numerous international commissions have called for the de-criminalisation of HIV exposure or transmission. 275 The overly broad criminalisation of HIV non-disclosure, exposure, or transmission are not only contrary to established public health evidence, but have also been shown to negatively affect health outcomes. 275 , 276 In many countries it is a crime for a person with HIV infection to have sex without disclosing his or her HIV status. In these settings, such laws are inequitably enforced, fail to meet any tangible public health objective —ie, reduce rates of HIV transmission 277 —and additionally, embed stigma and punish people for engaging in common behaviours such as sexual activity. The result is that individuals are driven underground, preventing them from accessing treatment, and potentially placing the broader community at risk. 275

Similarly, criminal laws have also posed barriers to the treatment and rehabilitation of people who use drugs ( panel 8 ).

Effects of the criminalisation of drug use on health and justice worldwide

Control of the cultivation, trafficking, and use of illicit drugs is an issue of global concern. The international legal drug control system is comprised of three treaties: the Single Convention on Narcotic Drugs of 1961, the Convention on Psychotropic Substances of 1971, and the UN Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988. Countries have a two-pronged obligation: to ensure adequate availability of drugs for medical and scientific purposes, while also preventing illicit production, trafficking, and use of such drugs. 278 Although the drug conventions require governments to take steps to reduce supply and demand for controlled drugs, these efforts must be balanced with countries' human rights obligations, 279 including their citizens' rights to health, dignity, and freedom from arbitrary detention.

The UN Office on Drugs and Crime has stated that the UN drug conventions do not require penalisation of drug use or drug possession for personal use, 280 , 281 and the system is grounded in a health framework explicitly stating that the “health and welfare of mankind” is its overarching concern. 282 Despite this, countries across the globe use criminal law measures to try and address the reduction of demand prong of their obligations—including 33 countries that maintain the death penalty for drug-related offences. 283 In many countries, sentences for minor drug dealing are longer than sentences for serious acts of violence such as murder, rape, or armed robbery, 284 and people imprisoned on drug-related charges make up a substantial proportion of prison populations worldwide. 282 In many countries, punitive drug control efforts have resulted in serious human rights abuse, including torture and ill treatment by police, mass incarceration, extrajudicial killings, arbitrary detention, and denial of essential medicines and basic health services. 282

The criminalisation of drug use has facilitated the spread of blood-borne viruses, particularly HIV, among drug users. Some of the most severe drug-related harms are associated with injecting drug use. Outside of sub-Saharan Africa, up to 30% of all new HIV infections occur among people who inject drugs with unsafe injecting practices. 285 In fact, HIV prevalence in countries that rely on punitive approaches is substantially higher (37–42% vs less than 5%) than countries that use public health approaches to drug use. 275 Furthermore, criminalisation has also been used to limit access to treatment options. Drug control efforts often have a disproportionate effect on vulnerable groups and marginalised communities, including indigenous populations, the poor, and racial or ethnic minorities. 286 In some countries, including the USA, treatment for hepatitis C has been restricted on the basis of a person's active injecting status. Criminalisation has also resulted in reduced access to disease prevention interventions, and proliferation of high-risk drug use behaviours in the absence of accessible harm reduction technologies.

Criminalisation can lead to people avoiding health (and potentially other needed) services for fear of arrest, and because of concerns about discrimination. Consequently, their health and wellbeing are harmed.

Another pertinent example involves people with mental disabilities incarcerated in the criminal justice system, rather than treated in a therapeutic environment. Studies of the US prison system show that “about 20 per cent of inmates have a serious mental illness, 30 to 60 per cent have substance abuse problems and, when including broad-based mental illnesses, the percentages increase significantly.” 287 Most inmates placed in seclusion have a mental health disorder. Beyond lack of any therapeutic intent, incarcerating people with a mental health disorder results in further marginalisation and discrimination of an already vulnerable group ( panel 9 ).

Law as a tool to support improvement of mental health disorders

WHO defines mental health as “a state of well-being in which every individual realises his or her own potential, can cope with the normal stresses of life, can work productively and fruitfully, and is able to make a contribution to her or his community”. 288 The WHO and Institute for Health Metrics and Evaluation category of mental health and substance use disorders encompasses several conditions including depression, anxiety, bipolar disorder, eating disorders, schizophrenia, intellectual developmental disability, and alcohol and drug use disorders.

Globally, the burden of mental health disease is substantial. Approximately 15–20% of the world's population have one or more mental or substance use disorders; 289 in 2016, approximately 1·1 billion individuals had a mental or substance use disorder. Some argue that the true burden of mental health and substance use disorder is even higher because of factors such as difficulties in accurate measurement and reporting, along with challenges in categorisation of overlapping conditions. 290

Mental health is neglected in most countries, particularly in relation to physical health conditions. Individuals with mental health disorders face pervasive stigma and discrimination, resulting in considerable disparities between the services available for physical and mental health, with decreased availability, accessibility, and quality of mental health services. 290

Although countries vary widely in access to mental health services, even the best performing systems have yet to meet the need, leaving a wide treatment gap between the need for treatment and actual service delivery. Estimates range from 76% to 85% of people with mental disorders not receiving treatment in low-income and middle-income countries, compared with 50% of comparable individuals in high-income countries. 291

WHO has identified the development of mental health policies and laws that promote human rights as crucial to the protection of people with mental health disorders, observing that such policies and laws are inadequate in most countries. 292 WHO's Mental Health Action Plan 2013–20 set a target that 50% of countries should have developed or updated their mental health laws in line with international and regional human rights instruments by 2020. 293

Although successful mental health policy involves myriad components, a foundational issue is access to affordable, quality mental health services, which requires laws supporting such access along with adequate funding for services. Historically, countries devoted their scarce mental health resources almost exclusively to high-cost inpatient services for relatively few acute cases, which has contributed to the treatment gap. As evidence has shown the effectiveness of community-based outpatient treatment and integration of mental and physical health services, countries are slowly transitioning their laws and policies accordingly.

A notable example is the UK's Improving Access to Psychological Therapies (IAPT) programme. Initiated in 2008, the IAPT programme provides evidence-based outpatient services to people with anxiety or depressive diagnoses. The programme has several unique features, including mandatory use of standardised evidence-based protocols with intensive clinical supervision and, crucially, providing the services free of charge at the point of care. 294 The UK invested £400 million in the programme from 2011 to 2015, and data indicate that about 950 000 people per year access IAPT for an initial assessment, of whom more than 537 000 receive therapy. 295 This increase in access has helped narrow the treatment gap by improving treatment rates for adults with anxiety or depression from 24% in 2007 to 37% in 2014. 294 , 296

Another example of a law designed to improve mental health is India's Mental Healthcare Act of 2017, a broad bill that seeks explicitly to comply with the UN Convention on the Rights of Persons with Disabilities. India has traditionally underfunded its mental health services, spending only 0·06% of its total health expenditures on outpatient mental health care, 297 and has a severe shortage of mental health providers, even when compared with other low-income and middle-income countries. 298 , 299 Among the new law's provisions is a requirement that insurers cover mental and physical health services in parity, which supporters hope will help combat the stigma surrounding treatment and lead to improved mental health outcomes.

The ongoing stigma surrounding mental health conditions and continued shortfalls in funding mean that change will come slowly, but the actions of countries such as the UK and India show that targeted laws can help speed progress toward improved mental health outcomes, particularly when coupled with adequate resources.

The criminal justice system can be especially unfair to women, particularly with regards to sex work and reproductive health. Laws criminalising sex work are globally ubiquitous. Sex workers are a highly marginalised group, and the illegality of their work often results in scant protection against abuse, violence, and financial extortion. 300 The criminalisation of sex work virtually eliminates the negotiating power of people engaged in sex work. Criminalisation makes it harder for sex workers to negotiate safe sex with their clients, and it increases the risk of violence, because sex workers are deterred from reporting violence to police. Some jurisdictions, such as New Zealand, have legalised sex work, but both legalisation and decriminalisation are controversial and politically difficult.

In many jurisdictions, reproductive choice and health, including access to safe contraception and abortion, are threatened. Despite WHO guidance, many countries have criminalised abortion and restricted family planning, and in some countries, women are imprisoned for involuntary miscarriage. 301 A 2016 study found that “abortion rates are not substantially different across groups of countries classified according to the grounds under which abortion is legally allowed.” 302 However, the study did find “the level of unmet need for contraception is higher in countries with the most restrictive abortion laws than in countries with the most liberal laws, and this contributes to the incidence of abortion in countries with restrictive laws.” 302

Laws that restrict or penalise reproductive health programmes and family planning not only cause stigma, but can also undermine public health messages. Several Latin American countries restrict reproductive rights. These restrictions caused major concern during the Zika epidemic, given fears about neurological disorders and neonatal malformations. 303 Countries in the Americas have observed an increase in babies born with microcephaly, with a clear association between microcephaly and exposure of the mother to Zika virus during pregnancy. 304 In 2016, WHO recommended that women in countries where Zika virus infection is a threat should delay pregnancy for several months to several years. 305 However, at the same time, several affected countries have strict barriers to accessing abortion, including laws that criminalise abortion for any purpose. 306 Women are consequently placed in an untenable position and can face a violation of their human rights. Such laws endanger the health of women, especially those who seek unsafe abortions because of the lack of access to legal abortion services.

Laws in other realms can also adversely affect the public's health. Many countries ban or restrict access to health services for non-nationals—particularly, but not only, undocumented immigrants. The law can also undermine the health of migrants in other ways. For example, immigration laws often require deportation of non-citizens infected with tuberculosis, which drives the population underground ( panel 10 ).

The effect of international law on the health of refugees—the case of tuberculosis

Nowadays, the world is facing the highest levels of displacement on record. 307 With an unprecedented 68·5 million people around the world forced from their homes—of whom, nearly 25·4 million are refugees and 10 million are stateless people—the origins and consequences of the displacement crisis remain some of the most formidable challenges of our modern time. 307 Attempting to address the myriad challenges that face refugees and asylum seekers across the world, the international community, by way of international law and treaties, has sought to foster norms on how countries treat refugees. The core instruments of international refugee law—the 1951 Convention relating to the Status of Refugees, and the 1967 Protocol 308 —provide protection for refugees by prohibiting refoulment of refugees, or forcible returning of refugees to places where they fear for their lives or freedom. 309

Although the law has taken important steps to protect the wellbeing of refugees, profound gaps persist and negatively affect the rights and experiences of refugees, particularly with respect to health. Yet even more troublingly, laws and policies themselves can hinder health outcomes and contravene well established public health principles. This twin dynamic of unmet need and avoidable harm is exemplified in national laws and policies surrounding refugees and tuberculosis. 310

From the start of the journey, through to arrival at the country of asylum, refugees and others who are subject to forced migration are susceptible to contracting tuberculosis. This vulnerability begins with refugees' experiences in their home country, where health-care infrastructure might be lacking or have broken down because of war. For example, before the 2011 crisis began, Syria had a relatively low burden of tuberculosis. 311 Although data regarding tuberculosis in Syria remains elusive, reports show a rapid rise of the disease in the country, which is still believed to only be a fraction of the actual burden. 311 , 312

After refugees leave their home country, the journey exacerbates their susceptibility to tuberculosis. Economic, social, and legal barriers increase the likelihood that tuberculosis will spread along the way and block access to care for those who contract it. These barriers, in turn, can lead to increases in the prevalence of tuberculosis in countries of asylum. Lebanon has been a country of asylum for Syrian refugees from the start of the conflict in 2011. 313 In the first year of receiving Syrian refugees, Lebanon saw a 27% increase in tuberculosis cases. 311

Reflecting this dynamic, countries enact national laws and policies regarding migrants and tuberculosis. For instance, some countries will not provide essential medical services to migrants with tuberculosis, some have legal requirements that individuals with tuberculosis undergo treatment as a condition of attaining legal status, and many detain and deport individuals who have or develop tuberculosis, frequently without providing necessary treatment. 310 In the USA, active tuberculosis is still one of the communicable diseases that trigger inadmissibility under the Immigration and Nationality Act, though a waiver may be possible. 314 These national restrictions based on tuberculosis claim public health as a justification, but directly contravene established public health principles and violate international law.

The WHO emphasises that screening of migrants, including refugees, for active or latent tuberculosis “should always be done with the intention to provide appropriate medical care, and never to exclude or preclude entry”. 315 Because tuberculosis is preventable, treatable, and curable, public health principles guide the international community towards identifying and treating every individual with active tuberculosis, regardless of location, immigration status, or socioeconomic status. 310 This approach builds on the experience of countries' HIV and AIDS responses and the International Health Regulations, which call for any measure to prevent the spread of an infectious disease to use the least restrictive means possible. 316

With respect to international law, countries have a right to exercise their sovereignty in imposing immigration restrictions. 317 However, international law requires that states only undertake measures that are consistent with human rights and other international obligations. These obligations include non-discrimination on the basis of other status, which includes health status. If states do indeed opt to limit rights, states must show that the limitations are necessary to achieve a legitimate aim, that the means achieve the stated aim, and that they are the least restrictive means. 318

People who fear deportation are unlikely to seek testing and treatment, placing infected individuals and the wider public at risk. Moreover, by interrupting continuity of care, deportation can jeopardise tuberculosis treatment for those who have already started it, which risks resistance developing to first-line tuberculosis medications. 310

Healthy people in healthy communities

A substantial body of evidence and learned experience shows that legal interventions can advance global health with justice. Around the world, law has been used to reduce health risks, examples of which include vector control and immunisation for infectious diseases, tobacco control, food reformulation, healthy built environments for non-communicable diseases, vehicle and road design, and increased road safety measures.

But the lessons of evidence and practice also run in the opposite direction. Too often, governments have used law for improper purposes, or with little consideration for the values of health with justice. In such cases, law can raise risks and create stigma. Inappropriate use of the criminal law has been deeply harmful in multiple spheres. For these reasons, policy makers should monitor and evaluate the effects of law on health and on justice. Legal determinant 3 encapsulates the need for ongoing evaluation of public health laws, ensuring that laws and their implementation are evidence-based, fair, intersectoral, and transparent. Laws that promote human rights, particularly the right to health, can be transformative; however, those that violate human rights can be deeply harmful.

Despite the firm foundation of the right to health in international law, the persistence of unconscionable health inequities and the lack of accountability to health commitments have led to calls for a new treaty on the right to health. The Framework Convention on Global Health (FCGH), an idea first suggested a decade ago, is a major proposal for a treaty based on the right to health. 319 The FCGH has since been supported by a growing number of civil society organisations, as well as national and global health leaders, 320 , 321 with this movement now crystallised through the FCGH Alliance . The FCGH would reinforce norms of equity, justice, and human rights; create mechanisms for inclusive participation, cross-sector cooperation, and accountability; and delineate national and global responsibilities for sustainable financing. 322 Rather than a piecemeal approach to discrete global health challenges, the FCGH would function as an overarching, rights-based framework under which all the vital components of the right to health could be realised, with additional protocols where needed to fill gaps. The FCGH would respond to the SDGs call for governments and international institutions to “leave no one behind.”

When research tells us that an intervention works, and when governments operate on the basis of sound scientific evidence and the rule of law, it becomes possible to create the conditions in which people can achieve health with dignity and human rights. Healthy populations and healthy communities start with the enactment and implementation of effective and just public health laws. Recommendation 4 urges governments to form country-appropriate mechanisms to advise on legal interventions that will impact the public's health and safety. These might take the form of national health law commissions, task forces, or other structures, with the aim of developing a systematic plan to identify and propose effective legislation. As part of this process, we also recommend that governments adopt legislation requiring HIAs for policies, programmes, and projects that might seriously affect health.

At the international level, recommendation 4 proposes that WHO use its constitutional law-making powers to adopt further international legal instruments to safeguard the public's health and safety. This approach would build on the successes of existing instruments, while also addressing deficiencies, and aim to understand and improve underserved areas such as mental health.

Section 5: legal determinant 4

Our final legal determinant of health underpins all the others: building and strengthening legal capacities for health. Robust legal architecture and resources for enacting, implementing, and monitoring public health legislation can bring to fruition all the legal determinants of health. Law and health should be mutually reinforcing, but the two fields often do not work synergistically, whether in research, practice, or philosophical orientation. In this section we make the case for, and set out the key features of, the legal capacities required to achieve health with justice.

Why build capacity?

Strong legal capacity for health will be a key determinant of progress towards global health and sustainable development. Yet, too often, countries lack the basic legal infrastructure or the capacity to build it. The WHO report, Advancing the right to health: the vital role of law, 86 put forward several reasons why legal capacity building is essential.

First, the report states that over time, laws have become outdated, fragmented, ambiguous, or incoherent. Therefore, health officials might lack the mandate and legal powers to implement new, evidence-based interventions. Outdated laws and existing interventions might stigmatise or penalise vulnerable individuals and communities, driving epidemics underground. Secondly, new and emerging health hazards might require new legislative frameworks. Public health laws are often introduced reactively, and then stay on the books for decades. In the face of emerging threats—whether novel pandemics, or new paradigms such as non-communicable diseases—these laws might not be fit for purpose. Conversely, an ambitious goal like achieving UHC calls for forward planning and proactive regulation. The WHO capacity building report also stated that governments might lack the legislative and regulatory tools to discharge their public health and human rights responsibilities effectively. Public health officials need a wide-ranging set of powers to carry out their responsibilities to safeguard the population. At the same time, the law must protect the civil and political rights of individuals, as well as their social, economic, and cultural rights, including non-discrimination and equal protection under the law. Protecting such rights is particularly relevant to achieving the SDGs, in which health, development, and human rights are closely intertwined.

In settings where regulatory and governance capacity is lacking, laws intended to protect the public's health might be poorly drafted or ineffectively implemented. In the absence of a sound legal infrastructure, the law might even undermine health goals.

How do we define legal capacity?

The term capacity building (or capacity development) originally comes from the lexicon of sustainable development. 323 Capacity can include “infrastructure, institutions, human knowledge and skills, and collective attributes such as social relationships, leadership and management.” 324 The UN Economic and Social Council defines capacity development as “the process by which individuals, organizations, institutions and societies develop abilities to perform functions, solve problems and set and achieve objectives.” 325

Just as public health requires governments to invest in health systems, it also requires investment in regulatory capacity and effective legal environments. 86 Legal capacity for health refers to three interlinked dimensions: effective legal environments (which include the infrastructure for drafting, implementing, and enforcing laws that promote health with justice, as well as fairly resolving grievances that arise); a strong and growing evidence base, built on the rigorous monitoring and evaluation of existing laws; and an empowered, transdisciplinary health law workforce. The latter includes connected networks of well trained professionals—legal and non-legal—who share information and strategies, and who provide technical legal assistance. 16 Building capacity means attending to each of these dimensions ( figure 5 ).

The overlapping dimensions of legal capacity building for health

An effective legal environment: a process, not an endpoint

Enacting a good health law is only the first step towards building an effective legal environment. Laws that are defined as on the books must be supported by effective processes for their drafting (including public participation), implementation, enforcement, monitoring, evaluation, and ultimately their revision or repeal where necessary ( figure 6 ). Ongoing evaluation and continuous quality improvement lead to legislation and regulations that demonstrably improve the public's health and safety.

Features of an effective legal environment

Drafting and enacting public health law

The most visible aspect of an effective legal environment for health is so-called law on the books—the group of enacted laws and regulations that makes up public health law. Traditionally, the focus of public health law was on the management of unsanitary environmental conditions (eg, drains, water, food, and housing), and the control of infectious diseases. 17 Nowadays we recognise that public health law encompasses a far wider range of topics. Specific public health laws include “laws that are intended as health interventions, laws that define the powers, duties and boundaries of health agencies and systems, and laws that have an impact on health but were not enacted primarily with population health in mind”. 5 Examples for each of these categories are provided ( panel 11 ).

Public health laws

Laws intended as health interventions

• • Standards: food safety; consumer protection; air quality; drinking water; drugs, cosmetics and medical devices; pesticides; occupational health and safety; road safety; hygiene and sanitation; vector control
• • Regulation and licensing of tradespersons and professionals: health workers; social workers; hair and nail stylists; tattoo artists
• • Regulation and inspection of premises: hospitals and nursing homes; bars and restaurants; food markets; docks; swimming pools; tattooing and tanning establishments
• • Pest and animal control: vector abatement (eg, mosquitoes, fleas, and rodents); dangerous or exotic animals
• • Infectious disease response: vaccinations; testing and screening; isolation and quarantine; contact tracing and partner notification; directly observed therapy
• • Tobacco control: age limits, smoking bans in public places; taxation; advertising and marketing bans and restrictions; packet labelling (or warnings) and plain packaging; bans on cigarette flavouring; nicotine reduction
• • Alcohol control: age limits; restrictions on marketing and advertising, package warning labels; prohibiting driving while intoxicated
• • Mental health laws: guardianship and civil commitment; mandatory or community treatment; rights protections
• • Promoting healthy diets: nutrition labelling on food products and restaurant menus; regulation of junk food advertising aimed at children; regulating food ingredients (eg, limits on trans fatty acids, added sugars or sodium); portion size limits; taxes on unhealthy foods (eg, sugar-sweetened beverages)

Laws that define the powers, duties, and boundaries of health agencies and systems

• • Laws establishing and governing public health agencies, including mission, powers, limits
• • Laws establishing and governing health-care agencies, including quality assurance, eligibility for services, essential medicines list, reimbursement for services
• • Laws protecting patients' and service users' rights and privileges
• • Privacy laws governing data held by health agencies and health-care providers, including data protection and confidentiality

Laws that have an effect on health, but were not enacted primarily with population health in mind

• • Planning and zoning laws: walking and biking paths; parks, playgrounds, and recreation; pedestrian zones and congestion taxes; limiting fast food outlets and encouraging supermarkets
• • Firearms regulation: weapons bans (eg, automatic discharge firearms); smart firearms (eg, discharge only with owner's fingerprints); safe gun storage; firearms training; background checks prior to purchasing
• • Social, welfare, and housing services and programmes: child protection and benefits; community centres (for the elderly or vulnerable) and support groups (for drug or alcohol dependency); pensions and disability benefits; income supports; nutrition programmes; public and subsidised housing
• • General taxation: progressive tax structures; negative income taxes; deductions for health care, child care, and public transportation expenses; eliminating tax havens or loopholes; fair and efficient tax collection

From pandemic responses to the prevention of non-communicable diseases, law on the books is a crucial determinant of what is achievable: empowering and obligating agencies to safeguard the public's health, but also protecting individual rights by placing limits on government and private action.

Governments first need capacity to write and enact laws and regulations. Such drafting should ensure that laws are comprehensible and systematic; adhere to principles of good governance and sound regulation, such as being developed through transparent processes with public participation; are evidence-based; are transparent and clearly communicated to the public, setting out health officials' powers and responsibilities, as well as their limits; are consistent with, and supportive of human rights; and promote equity. Many of these features are addressed in sections of this report.

Effective legal environments, like effective health environments, require transparency and accountability. Effective legal environments give affected populations and civil society organisations meaningful opportunities to participate in the decision-making process. Translating the goals and processes of health laws from the immediate context of policy makers and legal or health practitioners, to the wider public and the organisations that represent their interests, is crucial. This idea goes far beyond education or health promotion: rather, it means that affected communities should be genuine partners in, rather than targets of, health policy.

The global response to HIV and AIDS provides the most powerful illustration of community mobilisation. In the face of stigma, discrimination, and neglect, advocates raised social and political awareness, which ultimately generated the political will to take action. They demanded high quality research into the prevention and treatment of HIV infection. When interventions were developed, they advocated for the right to affordable access throughout the world. The response to HIV and AIDS is, of course, an ongoing struggle, and is only one major health hazard among the many that urgently require social mobilisation.

In areas where civil society voices are not yet sufficiently empowered—for instance, for non-communicable diseases, 326 injuries, or mental health—governments should actively seek public involvement in policy making, using public announcements, open forums, and public comment sessions. Consumers and health advocates should be invited to attend important meetings as partners alongside public officials, health professionals, and scientists. These governance mechanisms can incentivise public participation and help “dispel potential concerns of suspicion or mystification that might surround the development of public health laws”. 327

Public participation and open forums also enable civil society to understand the purpose of health law and engage more effectively in the policy process. In turn, this can support adherence to the norms and standards established by health laws. For example, in Denmark, public health groups worked with the government, industry bodies, and civil society organisations, to raise public awareness of the cardiovascular risks of consuming artificial trans fats. 328 , 329 This type of public engagement meant that when regulation limiting these harmful fats was introduced in 2003, it already had a high level of public confidence and support, and strong industry compliance—ultimately leading to a successful public health legal intervention.

Public participation can also mean opening the door to powerful vested interests. New York City's regulation limiting the portion size of sugary drinks (known popularly as the soda ban) received a great deal of community opposition. However, research subsequently showed that much of this opposition was led by organisations supported by the sweetened beverage industry. 330 The American Beverage Association (with Coca-Cola and PepsiCo as members) spent millions of dollars swaying public opinion against the soda ban, and ultimately succeeded in having the courts strike down the measure. Elsewhere, the food industry has spent lavishly to influence legislative processes on issues ranging from menu labelling to taxes on sweetened beverages. 331

Furthermore, as sales of unhealthy foods in higher-income countries have begun to lag, food companies are expanding their markets in developing countries by targeting community networks. An exposé in The New York Times , 332 describes the use of direct marketing by multinational Nestlé to sell sugary foods to poor people in Brazil, under the guise of nutrition and community empowerment. These grassroots efforts take place while food and beverage conglomerates enjoy an enormous amount of political and economic power in Brazil.

Policy makers must be alert to the risk that genuine community voices are likely to be weaker, less organised, and less well-funded than commercial players with substantial interests to defend. As such, governments should empower civil society organisations to meaningfully participate in the development of health laws. Health advocates also need to anticipate industry opposition and build broad-based community coalitions for health. 333

Implementation: inspections, monitoring, and enforcement

Effective legal environments are supported by systems of monitoring, inspections, and tools for enhancing compliance with public health laws and regulations. A range of different professions—including public health, food and drug, and environmental health officers; medical and nursing practitioners; scientists; and even police in certain contexts 17 —will have responsibility for monitoring and enforcing public health laws. These professionals exercise statutory powers as health officials, officers, or inspectors. For the purposes of enforcement, these powers usually include a range of responsibilities, described as follows: inspect and search premises or goods—eg, to ensure safe workplace environments, purity of food and drugs, or sanitary conditions of farms or restaurants; 327 issue orders to cease and desist unsafe conditions or activities, such as pest or animal abatement; issue formal notices of failure to comply; levy and collect fines; confiscate unsound goods; shut down unsafe businesses or premises; sanction professionals for poor quality or safety lapses, including the loss of a licence, permit, or accreditation needed to legally operate; publicly disclose instances in which there has been a failure to adhere to public health standards, such as by issuing prominent notices on restaurants of their sanitation and hygiene rating; and finally, engage in dispute resolution, when there is a legitimate disagreement between regulators and the regulated party. 327

Where disputes arise, the court system or other means of redress must be empowered to impartially adjudicate disputes, ensuring fair application of the regulations, and allowing regulated professionals or industries to contest decisions.

Research and evaluation

Ongoing monitoring and evaluation of the effects of laws and regulations are crucial steps in the process of ensuring effective legal environments for health, but are often overlooked. Because law has the power to affect diverse populations in different ways, it is crucial that policy makers rely on evidence, whenever possible, to distinguish between laws that work, laws that do not work, and laws that cause harm. Yet, nowhere else in the realm of public health are interventions used to treat so many people with so little evaluation of the effects. 201 A few exception areas, including alcohol and tobacco control, have showed the importance of evaluation in developing and spreading highly effective legal solutions. In the following section, we focus on a second dimension of legal capacity for health: a strong evidence base.

A strong evidence base, informed by the values of justice and equity

Health laws and regulations should be informed by a robust body of evidence regarding their effectiveness in reducing risks of injury and disease. In this section, we make the case for strengthening the evidence base in relation to the design and use of health law research. At the same time, we acknowledge the important role of values in health policy innovation. As we have noted throughout this report, public health is not simply the application of technical solutions to health problems. Rather, it is unabashedly infused with the values of social justice and grounded in the language and practice of human rights. Although we recognise that the law-making process is embedded in politics, we urge policy makers to critically evaluate existing evidence, support ongoing health law research, and prioritise the right to health and other human rights.

Health laws must be based on robust evidence

Since the turn of the 21st century, public health law as a field of scholarship has undergone a renaissance: its philosophical orientations, conceptual frameworks, and core debates have been well articulated. 15 Building on this, researchers and policy makers are now recognising the growing need for empirical research. Empirical research can relate to any of the stages in figure 6 —from the design of laws, to their monitoring and enforcement—and aims to answer the questions: which laws or practices are associated with better health outcomes? Which laws or practices are associated with worse health outcomes? Which laws impose undue burdens, particularly on disadvantaged populations? How can these laws or practices be improved, for population health and the protection of human rights?

Law is rarely amenable to what scientists regard as the so-called gold standard of evaluation, which is the randomised clinical trial. Nevertheless, the impact of law can be studied scientifically, the study of which leading scholars describe as legal epidemiology. 334 Legal epidemiology aims to study law as a variable that can affect health outcomes. For example, it might rigorously examine whether a law is correlated with a particular health outcome, or compare outcomes in jurisdictions that have implemented similar or different laws—noting that contextual factors will mean that success in one jurisdiction will not necessarily predict success in a neighbouring jurisdiction. Comparison of health effects before and after implementation of a law is also a useful research tool. Health law research can also survey those who implement laws, and those affected by them, to ascertain their effects on the ground.

Empirical health law research employs scientific, quantitative methods to assess the effect of laws and to improve their design. Such empirical research methods include evaluating the policy-making process, so-called mapping particular categories of laws or regulations, examining how laws are implemented and enforced in practice, intervention studies, and close analysis of the legal mechanisms of particular interventions. 334 Beyond strengthening the evidence base, this type of research can have far-reaching social and political effects. Research findings can strengthen political and public support for the enactment of particular health laws (by giving an evidence-based rationale for their implementation) and, at a deeper level, can also help strengthen the philosophical and practical linkages between law, health, development, and related disciplines.

A persistent reason for public opposition to health laws lies in the claim that they are paternalistic: an intrusion by the so-called nanny state onto individuals' freedom to choose what to eat or how to behave. Opponents argue that certain public health laws force individuals to act in ways they would not otherwise choose—such as compelling them to wear a motorcycle helmet or raising the price of sugary drinks. Health advocates can use normative reasoning to address claims of paternalism—arguing, for example, that these laws increase wellbeing and reduce health-care costs. However, objective evidence of positive behaviour changes that improve health can be a more powerful counter to such so-called nanny state arguments.

Well designed studies often require access to large datasets, medium-to-long-term funding and perhaps most importantly, a workforce of interdisciplinary researchers. 335 Universities, which have played an important role in the expansion of global health as a discipline, 6 can help to build such a workforce by offering health training to legal graduates, and legal training to health professionals. As a global health community, we need to set, and drive forward, a clear and ambitious research agenda. We need to build consensus on the key questions that require answers and the laws in most urgent need of evaluation, and to prioritise resources accordingly. 336 Given that society invests substantial political and economic capital in enacting and enforcing public health laws, devoting resources to enable high-quality research into their effects would be worth the investment.

But evidence is not the only consideration

Even as we advocate for high-quality empirical research on the relationship between law and health, we recognise that evidence is only one important aspect of a well regulated society. Policy makers often must act on the basis of incomplete scientific information, taking social values into account. In some cases, the call for full objective evidence before enacting any public health intervention can stifle innovation. If a new law represents a sharp turn from accepted practice, the case for reform will often require building an evidence base over time.

In settings where law makers have good grounds for believing that legislation will have positive effects, and have a plan for ongoing evaluation, they should have the leeway to introduce novel ideas. For example, following the first case of HIV transmission via drug-injecting equipment in 1985, Australia quickly introduced a Needle and Syringe Programme (NSP). The NSP provided sterile drug injection equipment and facilities for the safe disposal of used equipment. The programme also became a first point of contact between injecting drug users and health services, providing education, information, and onward referrals to drug treatment, medical care, and legal and social services. 337

Evaluations of NSPs in Australia found them to be “the single most important and cost-effective strategy in reducing drug-related harms among [persons who inject drugs]”, 338 and the programme has been endorsed by WHO, UNAIDS, and the UN Office on Drugs and Crime. Yet initially, experts and policy makers faced intense opposition. The evidence was not watertight, but policy makers had to act decisively to stem a potential epidemic. In doing so, they were guided by human rights principles and the need to protect a susceptible community. Once adopted, programmes such as NSPs can and should be subject to rigorous empirical examination. As of 2019, we have robust evidence that NSPs help prevent the transmission of blood-borne diseases and save lives. As observed with so many public health successes, the lack of complete evidence did not act as a barrier to innovation. Therefore, governments should establish infrastructure to enable early, rapid, and systematic evaluation of innovative policy ideas. 339

An empowered, transdisciplinary health law workforce

Finally, effective legal environments are only possible with a knowledgeable and capable health law workforce. As the linkages between global health and the law become stronger, the need for an empowered, transdisciplinary health law workforce will become more pronounced. Recognition of the potential for legislative and regulatory interventions to improve population health is growing; however, this is not matched by the availability of skilled professionals who can implement and evaluate such interventions. 340 Although difficult to quantify numerically, in our assessment, the deficit is marked. We identify three aspects central to building the necessary workforce capacity: building disciplinary bridges, building knowledge and skills, and building networks.

Building disciplinary bridges

Researchers and practitioners in law and in health have traditionally worked in quite distinct ways. In the medical profession, as in the wider public, understanding or recognition of the power of law to drive behavioural and social change is lacking. Health professionals might even have a negative view of the legal profession, perceiving lawyers as adversaries bringing malpractice litigation. 340 For their part, lawyers can be protective of their turf and unwilling to acknowledge the limits of their subject-matter expertise. This silo mentality leads to missed opportunities for teaching, research, practice, and problem-solving. Colleges and universities are uniquely positioned to address this problem, but these institutions alone are insufficient to foster the necessary health law ecosystem. Building the empirical evidence base for effective health laws first requires building disciplinary bridges: mutual understanding, collaboration, common terminologies, and an appreciation of how different skill sets can be applied to public health problems. It also requires genuine interdisciplinary (or even transdisciplinary) 16 research, drawing on the expertise of legal scholars, epidemiologists, clinical scientists, policy analysts, behaviour change experts, and anthropologists, amongst others, working together.

Building knowledge and skills

The interdisciplinary or transdisciplinary nature of health law presents unique challenges for teaching and training. Nevertheless, equipping law graduates with health knowledge and epidemiological skills, and health graduates with an understanding of the role of law and governance in creating healthy environments, is crucial for building capacity. Both health graduates and law graduates should be introduced to the basics of international human rights law. Education in public health, law, and policy should include the range of skills needed in a transdisciplinary public health law practice, including policy development, basic principles of law and legal procedure, advocacy, ethics, implementation and enforcement, and legal epidemiology. 16 , 201 Schools of medicine, nursing, public health, and law can teach a broad curriculum encompassing a variety of transdisciplinary skills. These schools can also collaborate to offer joint degrees, such as a Juris Doctor with Master of Public Health or Juris Doctor with Doctor of Medicine.

Academic institutions have the opportunity to successfully deliver training and teach skills to help resolve specific health challenges—for instance for non-communicable diseases, access to medicines, and injuries. Solutions to all of these complex health problems require a variety of scientific and legal skills. Progress in these areas can be achieved only if health advocates have access to the training and resources needed for deep understanding not only of the health hazard, but also of the legal rules and mechanisms that govern the particular field. Understanding the field of non-communicable diseases and the law requires a strong understanding of multiple other areas, including consumer law, marketing law, food law, tax law, and environment and planning law. 341 Similarly, the law surrounding access to medicines requires understanding the linkages between trade law, intellectual property law, and health. 340 Health advocates push for affordable access to medical technologies, but to be truly effective they need the acumen to understand the legal rules governing the pricing and regulation of vaccines and medicines. 342

Health diplomacy is another crucial legal capacity. Whether at the national, regional, or global level, legal and health professionals must develop the skills and gain the experience needed to bridge often bitter ideological and political divisions to forge effective norms and standards. Health diplomacy requires the ability to genuinely listen to the concerns of stakeholders, while identifying common ground and finding fair and innovative ways to coax the parties toward consensus. WHO explains that global health diplomacy “brings together the disciplines of public health, international affairs, management, law, and economics, and focuses on negotiations that shape and manage the global policy environment for health”. 343 Effective health diplomacy can operate at the national level (eg, negotiations over new legislation or regulations, especially where health considerations need to be integrated in non-health legislation) and at the transnational level (eg, negotiations over new health treaties, global action plans, or codes of practice). The complex negotiations over the FCTC, the IHR, or the PIP Framework all provide good examples of the need for skilful health diplomacy. Academic institutions can partner with governments and international organisations to fill these gaps in knowledge and skills. For instance, academic institutions could help train the workforce charged with implementing health laws and international agreements.

Building networks

Trained health law professionals must also have the opportunity to share knowledge, strategies, and expertise. This approach is of particular relevance in relation to new and emerging areas of law, and in resource-constrained environments. Many low-income and middle-income countries do not have a cadre of trained health law professionals, and health lawyers are also scarce in many high-income countries. In such cases, networks of experienced health lawyers could collaborate with local health professionals, lawyers, and policy makers to strengthen local capacities.

Training in health law could strengthen the contribution of a variety of professions or groups to advancing health with justice. These include officials of international organisations such as WHO, the WTO, and the World Bank; officials in regional organisations such as WHO regional offices, regional alliances such as the Association of Southeast Asian Nations, the Organization of American States, or the European Union; policy makers and public officials in health or justice ministries who have responsibility for developing, implementing, or enforcing health laws and regulations; officials in other ministries, whose work could have an impact on public health (eg, agriculture, trade, urban planning, foreign affairs); 86 front-line government workers who might be involved in enforcing health laws (eg, customs or taxation officials); 344 personnel responsible for funding decisions, programmes, and policy making within health-related entities, such as non-governmental organisations, philanthropies and PPPs; lawyers who work closely with health agencies or programmes; 336 and lawyers tasked with defending new health laws from legal challenges.

Network-building and collaboration have been especially important in cases where health advocates face powerful, organised resistance from vested interests. The FCTC explicitly calls for legal capacity building and knowledge sharing in litigating tobacco control cases, such as defending strong tobacco control laws or suing tobacco companies for deception or unfair marketing. These calls have been realised through the efforts of professional groups (eg, the so-called lawyer's circle for tobacco control, which connects legal expertise in high-income countries with that in low-income and middle-income countries), civil society (eg, the Framework Convention Alliance, made up of 500 member groups worldwide), and philanthropies (eg, the Bloomberg International Legal Consortium, which provides resources for legal capacities in tobacco control). Earlier we mentioned food industry opposition to new laws facilitating healthier population diets. Ensuring that the food industry does not undermine efforts to protect public health could be another area in which cross-jurisdictional networking would be particularly valuable. As multinational organisations expand their markets, a trained cadre of well-connected health lawyers can help guide health legislation, regulations, and litigation to ensure the public's health and safety.

Public interest law organisations can act as centres of excellence, sharing their knowledge and expertise gained from grassroots experience. In South Africa, Section 27 combines legal action with research and advocacy in its pursuit of human rights and social justice. Building on past success in mobilising legal and community action around HIV and AIDS, as of 2019, Section 27 focuses on access to health care, the right to food, and good governance. In India, the Lawyers' Collective works at the intersection of health, human rights, and the law; fighting for access to medicines; and the rights of women, the lesbian, gay, bisexual, transgender and intersex community, and those living with HIV and AIDS.

In the USA, the Network for Public Health Law lawyers connects public health practitioners; local, tribal, state and federal officials; policy makers; public health advocates and organisations; and provides training and technical assistance. 345 Its areas of legal expertise include overdose prevention, health data sharing, injury prevention, maternal and child health, and environmental health. In the USA, medical–legal partnerships bring together health, public health, and legal expertise for the benefit of patients, but also bring about systemic changes and improve population health. 346 Medical–legal partnerships guide patients through the complex terrain of the health-care system, enabling them to claim their rights and gain access to the services they need.

Strong capacity for an effective legal environment

Throughout this report, we have identified multiple ways in which the law can be a powerful instrument for the public's health and justice, focusing on effective, coordinated, and strategic uses of law. Building legal capacity is the common denominator. Governments, international organisations, funders, non-governmental organisations, academic organisations, and other health institutions can take concrete, practical action to support states as they build legal capacity. Such measures fall under three interlinked dimensions: effective legal environments, which should be supported by a strong evidence base, and an empowered, transdisciplinary health law workforce.

Although all of our recommendations relate to capacity-building, we have made four targeted recommendations to a variety of institutional actors. In recommendation 5, we call on WHO to partner with governments, foundations, and civil society, to expand the evidence-base for public health laws (including research and information sharing), and support strategies to enact and implement national and global health laws that are effective and sustainable. Recommendation 6 is for governments to build national capacities to enact and effectively implement public health laws. This relates to leadership, planning, funding, and professional training. Finally, in recommendation 7, the Commission offers to partner with The Lancet to create a standing commission on global health and the law, building on the momentum of this Commission.

Section 6: recommendations

In the following seven recommendations (summarised in panel 12 ), we propose a public health law action agenda consisting of legal instruments, legal capacities, and institutional reforms as tools for achieving global health with justice. Our programme of action is based on principles of human rights and good governance, founded on the right to health. Overarching the specific aims in each recommendation, we intend these recommendations to help foster conversations among policy makers and health workers, researchers, public health authorities, civil society, and others who work in global health.

Commission recommendations for the legal determinants of health

Legal determinant 1: using law to translate vision into action on sustainable development

Recommendation 1: the UN, WHO, and international partners should set standards to support the implementation of, and objectively evaluate compliance with SDG 3.8 Universal Health Coverage (UHC), as well as the upcoming UN political declaration on UHC in 2019

Who must take actionable steps: the UN, WHO, and international partners Recommendation 2: governments should strengthen or create a legal framework, such as a constitutional or statutory right to health, to ensure rights-based UHC on the basis of principles of equity and non-discrimination, including affordability, financial protection, transparency, accountability, participation, privacy, and sustainable financing Who must take actionable steps: national governments

Legal determinant 2: using law to strengthen the governance of national and global health institutions

Recommendation 3: the UN, WHO, and international partners should use their respective powers and influence to safeguard the public's health and safety through the creation or adoption of good governance standards, embracing the highest principles of equity, inclusive participation, transparency, and accountability Who must take actionable steps: UN, WHO, and international partners Recommendation 4: governments should develop legal frameworks that establish principles of good governance throughout national health systems and policy making, form a country-appropriate mechanism to advise on legal interventions with high health impact, and adopt legislation requiring health impact assessments for policies, programmes, and projects that might seriously affect health Who must take actionable steps: national governments

Legal determinant 3: using law to implement fair, evidence-based health interventions

Recommendation 5: WHO should increase its legal capacity to enable it to spearhead development of a global evidence base for public health laws and to support the enactment and implementation of national and global health laws that are effective and sustainable Who must take actionable steps: WHO, national governments, foundations, and civil society

Legal determinant 4: building legal capacity for health

Recommendation 6: governments should build national capacities to enact and effectively implement public health laws Who must take actionable steps: national governments Recommendation 7: WHO and The Lancet should partner with legal and health experts to create an independent standing commission on global health and the law that would advance the health-related SDGs by proposing evidence-based legal interventions for addressing major global health challenges, reforms of the global health architecture and international law, and strategies to build and strengthen global and national health law capacities

Who must take actionable steps: The Lancet and WHO

Legal determinant 1

Recommendation 1 states that the UN, WHO, and international partners should set standards to support the implementation of, and objectively evaluate compliance with, SDG 3·8 (UHC), as well as the upcoming UN political declaration on UHC in 2019.

WHO should develop a joint external evaluation (modelled on the IHR's JEE) of country compliance with SDG 3·8 and the UHC political declaration. Under the JEE, national and peer country stakeholders and external experts would evaluate UHC laws, regulations, and programmes against rights-based benchmarks, make such evaluations publicly available, and issue recommendations.

WHO or the UN should establish an international legal framework to ensure that high-income countries and other development partners provide the funding and expertise necessary for all countries to implement UHC, in line with their right to health obligations. 157

Recommendation 2 states that governments should strengthen or create a legal framework, such as a constitutional or statutory right to health, to ensure rights-based UHC on the basis of principles of equity and non-discrimination, including affordability, financial protection, transparency, accountability, participation, privacy, and sustainable financing.

Governments should promote sustainable financing and financial protection by allocating an adequate share of GDP to implement UHC. They should ensure quality through accreditation systems for public and private sector health facilities, pharmacies, and professionals; inspection of health facilities; and drug and medical device approvals based on safety and efficacy. They should also prevent health sector corruption and misappropriation of resources by establishing strong public financial management systems and anticorruption mechanisms, and avoiding conflicts of interest.

Legal determinant 2

Recommendation 3 advises that the UN, WHO, and international partners should use their respective powers and influence to safeguard the public's health and safety through the creation or adoption of good governance standards, embracing the highest principles of equity, inclusive participation, transparency, and accountability.

The UN General Assembly should adopt a set of good governance standards, reflecting best practices in governing complex public institutions for UN specialised agencies such as WHO, civil society organisations, and others. These standards should ensure the operations of the institutions are consistent with the highest principles of equity and transparency. WHO should additionally establish an independent unit tasked with ensuring effective implementation of such governance standards.

As a normative agency with law-making powers, WHO should use these powers to adopt international legal instruments to safeguard the public's health and safety, prioritising health threats in low-income and middle-income countries and developing compliance mechanisms. They should explore a global treaty focused on the right to health, equity, and accountability, such as the proposed FCGH.

Recommendation 4 suggests that governments should develop legal frameworks that establish principles of good governance throughout national health systems and policy making, form a country-appropriate mechanism to advise on legal interventions with high health impact, and adopt legislation requiring health impact assessments for policies, programmes, and projects that might seriously affect health.

Governments should develop national laws and regulations that safeguard inclusive participation in health-related decision making, from community to national levels, which require transparency. They should also establish mechanisms that ensure accountability, guarantee equitable distribution of health services, and require multi-sector action on health equity.

Governments should form a national health law commission, task force, or other structure to develop a systematic plan to identify and propose legislation with high impact on the public's health and safety. The commission or other mechanism should base its recommendations on the best available evidence, focus on equity, propose repealing or reforming existing laws that undermine the right to health, and address the broader socioeconomic determinants of health.

Governments should develop HIAs through inclusive participation, with compliance, and reinforced by independent oversight. These should analyse the anticipated impacts of health and non-health sector policies on health before implementation, should be regularly monitored, and where possible, should be enhanced with real-time assessments. HIAs should actively promote the public's health and guide decision makers' choices about available options to prevent injury and diseases.

Legal determinant 3

The WHA should provide WHO with the resources and political backing to develop WHO's capacity to support member states in developing public health laws on the basis of evidence, equity, and human rights.

The WHO should increase its legal capacities to include a robust global network of well-trained experts, linking existing repositories and databases of national health legislation, and developing platforms and information systems. These changes would enable health lawyers, medical professionals, policy makers, and advocates to share information and strategies on laws and litigation, as well as increasing legal skill sets within the WHO Secretariat at headquarters, and at regional and country levels.

Legal determinant 4

Recommendation 6 states that governments should build national capacities to enact and effectively implement public health laws.

Ministries of health and justice should lead an inter-ministerial, multi-stakeholder process, which includes civil society, to develop a strategic plan to build health law capacities, working to strengthen or create institutions to lead and coordinate health law research and development, identifying priority areas for public health laws.

Governments and foundations should support research to build a high-quality empirical foundation for evidence-based, rights-based, equity-based laws that provide health coverage and safeguard the public's health and safety, expanding research on existing public health laws and developing open access databases to share public health law research.

Recommendation 7 suggests that WHO and The Lancet should partner with legal and health experts to create an independent standing commission on global health and the law that would advance the health-related SDGs by proposing evidence-based legal interventions for addressing major global health challenges, reforms of global health architecture and international law, and strategies to build and strengthen global and national health law capacities.

As an example, this standing commission could recommend a comprehensive and legal reform agenda for global health security that would examine issues such as potential improvements to the IHRs, incentives for bringing countries into full compliance with IHR obligations and the JEE process, better coordination of laws relating to animal and human health, greater harmonisation of regulatory standards to accelerate development of vaccines and other countermeasures, and improvements to benefit-sharing frameworks. This potential legal reform agenda could feed into the work of the newly established Global Preparedness Monitoring Board, which will monitor progress, identify gaps, and advocate for efforts needed for global preparedness for outbreaks and other health emergencies, and help ensure it fully considers legal issues and possibilities.

Acknowledgments

Principal support for the Commission's work was provided by the O'Neill Institute for National and Global Health Law at Georgetown University Law Center. The Rockefeller Foundation provided in kind support using The Bellagio Center for a Commission summit in Bellagio, Italy. The WHO, the World Bank Group, and UNAIDS supported the Commission with expertise and technical guidance. The Commission also received support and guidance from Oscar Cabrera (O'Neill Institute for National and Global Health Law) and drafting support from Anna Roberts (Macfarlane Burnet Institute for Medical Research and Public Health), Dalia Deak (Harvard Law School), Emily Whelan Parento (University of Louisville School of Law), and Sonia Canzater (O'Neill Institute for National and Global Health Law). Over the course of the report's development, technical advice and input was received from Scott Burris (Temple University), Jeffrey Crowley (O'Neill Institute for National and Global Health Law), Sam Halabi (University of Missouri), Daniel Hougendobler (O'Neill Institute for National and Global Health Law), John Kraemer (Georgetown University), Benjamin Mason Meier (University of North Carolina), Benn McGrady (WHO), Michael Myers (The Center for Tobacco Free Kids), Alex Phelan (Center for Global Health Science and Security), and Virginia Rowthorn (University of Maryland). Project support was provided by Andres Constantin, (O'Neill Institute for National and Global Health Law), Brenna Gautam (Georgetown University Law Center), Han-Hsi Liu (O'Neill Institute for National and Global Health Law), and Patricio López Turconi (Universidad Torcuato Di Tella). Finally, the Commission owes immeasurable thanks to the students and scholars around the world who supported the project with their dedicated research and endless passion. Global health advocates and scholars make the future of global health law promising.

Contributors

All authors contributed to the structure and concept of the report, the editing of drafts, revisions of key intellectual content, and the writing of the recommendations and key messages. The report was prepared under the direction of Commission co-chairs Lawrence O Gostin and John Monahan.

Declaration of interests

We declare no competing interests.

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Leveraging the profound impact of real-world success stories, case studies stand out as indispensable assets in law firm marketing. They not only underscore your firm’s expertise and capacity for achieving favorable outcomes but also play a crucial role in fostering trust and credibility among prospective clients.

Here is a guide (with homework!) on how law firms can effectively incorporate case studies into their marketing materials enhancing engagement and building their reputation as a leader in their respective areas of practice.

• Comprehensive Analysis : Craft case studies to provide a thorough analysis of significant legal matters, outlining the client’s challenge, the firm’s approach and the successful resolution. Ensure the narrative highlights the firm’s legal acumen and strategic thinking.
• Client-Centric Focus : Center the narrative around the client’s needs and journey, demonstrating empathy and a deep understanding of their situation. This approach makes the case study relatable and emphasizes the firm’s commitment to client success.
• Multimedia Elements : Enhance the case studies with images, graphs or video interviews of attorneys discussing key aspects of the case. These elements add depth to the story and help demystify complex legal processes.
• Incorporate Client Testimonials : If possible, include client testimonials within the case studies to add authenticity and provide a first-hand account of the firm’s impact.
• Showcase Practice Area Expertise : Utilize case studies to highlight the firm’s proficiency across various practice areas, demonstrating versatility and a comprehensive approach to legal services.
• Educational Value : Ensure the case studies also serve an educational purpose, offering insights into legal strategies, industry-specific challenges or legislative implications.
• Optimize for Search Engines : Make the case studies easily discoverable online by optimizing for search engines. Use relevant keywords and ensure the content is accessible on the firm’s website.
• Social Media Promotion : Create bite-sized summaries or key takeaways from the case studies for sharing on social media, driving engagement and website traffic.
• Client Presentations : Utilize case studies in pitches or presentations to potential clients, showcasing the firm’s successful track record and solution-oriented approach.
• Training Resources : Employ case studies as training materials, providing practical examples to help junior attorneys bridge the gap between theory and practice.
• Maintain Relevance : Regularly update the case studies to reflect new developments, ensuring the content remains current and relevant.
• Accessible Design : Design a user-friendly section on the firm’s website dedicated to case studies, ensuring potential clients can easily find and navigate through the success stories.
• Clear Call-to-Action : Conclude each case study with a call-to-action, encouraging readers to reach out for more information or to discuss their legal needs.

By strategically integrating legal case studies into their marketing materials, law firms can effectively demonstrate their expertise, foster trust and engage meaningfully with their target audiences.

Homework: Putting Case Studies into Action

Now that you’ve learned how to leverage legal case studies in your marketing materials, it’s time to put this knowledge into action. Here’s a homework task to help you get started:

Task: Create a Mini Case Study

• Select a Matter : Choose a recent legal matter that had a successful outcome and involved interesting legal strategies or challenges. Ensure you have client permission or anonymize the details to maintain confidentiality.
• Client Challenge : What problem was the client facing?
• Legal Strategy : What approach did your firm take to address the issue?
• Outcome : What was the result of your firm’s involvement?
• Client Testimonial (if available): Include a short client quote about their experience.
• Create a Visual Element : Design a simple infographic or visual aid that highlights the main points of the case study. You can use free online tools like Canva for this task.
• Share on Social Media : Share your mini case study on one of your firm’s social media platforms. Include a brief introduction, the visual element, and a call-to-action encouraging viewers to contact your firm for similar legal assistance.
• Reflect : After posting, reflect on the process. How did it feel to showcase your firm’s success? Did you receive any feedback or engagement from clients or peers?
• Plan for Future Case Studies : Based on this experience, think about how you can incorporate more detailed case studies into your firm’s broader marketing strategy. What worked well? What could be improved?

By completing this homework task, you will have taken a tangible step toward integrating case studies into your marketing efforts, providing a practical example of your firm’s expertise and success. Remember, the goal is to build trust and showcase your firm’s capabilities, one success story at a time.

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• Hospitality Case Review: The Top 100+ Hospitality Cases That Impacted Us in 2018

Written by Karen Morris, J.D., LL.M. and Diana S. Barber, J.D., CHE, CWP

ADA/Standing 1. Brito v. Wyndham Hotels and Resorts, LLC , 2018 WL 317464 (D. Colo., 01/08/2018). Plaintiff is a paraplegic and requires the use of a wheelchair to ambulate. While at defendant hotel he encountered multiple violations of the Americans with Disabilities Act (ADA) that effected his use and enjoyment of the premises and sued. The hotel challenged plaintiff’s standing. To establish standing, a plaintiff must show, inter alia, that he suffered an injury in fact. To prove that, plaintiff must establish a likelihood that he will return to defendant’s premises. Factors a court considers are the proximity of the business to plaintiff’s residence, the plaintiff’s past patronage of the business, the definitiveness of plaintiff’s plan to return, and the plaintiff’s frequency of travel near defendant. In the complaint plaintiff stated he lives in the same county as defendant, he has frequented defendant hotel for “pleasure purposes,” he was a guest at the premises for a two day stay, and he alleges an intention to return within four months. This constitutes a personal stake in the outcome to constitute standing and avoid dismissal of the complaint.

Bankruptcy 2. In Re Lorraine Hotel 2017 LLC , 2018 WL 5288893 (N.D. Ohio, 10/22/2018). Plaintiff hotel filed a Chapter 11 petition in bankruptcy. The debtor’s sole asset was a 93-room hotel, of which 54 rooms were rentable. The debtor did not have casualty insurance covering destruction of, or damage to, the facility. The Bankruptcy Code, Section 1112(b) authorizes a judge to dismiss or convert a Chapter 11 case to Chapter 7 “for cause.” Cause exists where a debtor fails to maintain appropriate insurance resulting in risk to the estate. The court stated appropriate insurance coverage is of “paramount importance” in this case because of the single asset in the estate and the status of the business as a struggling downtown hotel. The court thus dismissed the Chapter 11 case and denied conversion to Chapter 7. Instead, creditors can pursue their state remedies.

Class Action 3. Valverde v. Xclusive Staffing, Inc., et al , 2018 WL 4178532 (D. Co., 08/31/2018). Plaintiff is an employee of Omni Hotel. Per the written employment policies of the management company that operates the hotel, a $3.00 processing fee is deducted from each paycheck plaintiff and other employees receive. Plaintiff objected and seeks certification of a nationwide class of plaintiffs. Defendant objected arguing the allegations were insufficient to show that plaintiffs from other states were subject to the same policy. The court noted that defendant management company’s policies are national and controlled centrally from its Colorado headquarters. They are contained in its written employment policies used nationwide. The court thus found the evidence sufficient to certify a nationwide class.

Contracts 4. Murphy Elevator Co., Inc., v. Coco Key Hotel & Water Resort , 2018 WL 1747924 (Ohio Appls Crt, 04/11/2018). The parties had a two-year elevator maintenance contract. After the first year and a half, the hotel failed to pay. The elevator company stopped performing and sued for breach of contract. The hotel argued that it should only be liable for the unpaid moneys up to the time plaintiff stopped performing. The court rejected this argument and granted the elevator company lost profits. Noted the court, an award of damages should put the injured party in the same position it would have been in had there been no breach.

5. Stanciel v. Ramada Lansing Hotel and Conference Center , 2018 WL 842907 (Mich. Appls, 02/13/2018). Plaintiff fell when entering a hot tub at defendant hotel. Plaintiff attributes the fall to a broken support bar leading into the tub. Plaintiff sued, and the parties purportedly agreed to a settlement. Defendant prepared a written settlement agreement and submitted it to plaintiff. The documents included a “Medicare addendum.” Defendant’s attorney told plaintiff’s counsel to advise if he had a problem with any of the wording. Plaintiff returned the signed documents to defendant but unilaterally crossed out language in the addendum. Plaintiff now seeks to enforce the settlement agreement. Defendant argued the agreement was not valid because defendant was not willing to agree to the settlement without the eliminated clause. Plaintiff argued the clause that was crossed out was not an essential term of the settlement agreement so there was still a meeting of the minds on all the essential terms. The court ruled the parties did not reach an enforceable settlement agreement. Case dismissed.

6. Claris, Ltd. v. Hotel Development Services, LLC , 2018 WL 3203053 (Crt. Appls, Ohio, 06/29/18). Per contract dated 8/2005, defendant agreed to build plaintiff a 4-floor, 122 room hotel which plaintiff planned to operate as a Candlewood Suites. The construction was completed in late summer 2006. In 2013 the hotel began experiencing water penetration when rain occurred. Plaintiff’s expert witness investigated defendant’s construction work of the hotel’s walls and identified five deficiencies. The expert excluded one of the five as the cause of the water problem but did not identify the extent to which the other four may have contributed to the damage. Therefore, plaintiff failed to establish that a breach of contract by defendant caused the leakage. Thus, the court reversed a jury verdict in favor of plaintiff and directed a verdict for defendant.

7. Couture Hotel Corporate v. US , 2018 WL 3076847 (Crt. of Fed. Clms, 06/21/2018). Plaintiff purchased a $9 million hotel near Nellis Air Force Base intending to participate in the off-base lodging business for visitors to the base utilized when on-base lodging is full. To meet the base’s requirements, plaintiff made modifications costing in excess of $1 million. When the work was completed, defendant advised plaintiff that, due to lowered demand, it was not adding any new facilities to its overflow listings at the time. Plaintiff sued, claiming that defendant’s refusal to permit plaintiff to compete for off-base services violated the Competition in Contracting Act, various associated procurement regulations, and a contract implied-in-fact. The court held for the government finding procurement rules were not violated, and a contract-in-fact did not exist. While the government representative talked to plaintiff about prerequisites to qualify for the lodging overflow business before plaintiff purchased the facility, documents provided to plaintiff clearly stated that a prerequisite to the government signing a contract were various inspections and approvals. Said the court, “[I]n negotiations where the parties contemplate that their contractual relationship would arise by means of a written agreement, no contract can be implied.” The complaint was thus dismissed for failure to state a claim.

Default Judgment 8. Travelodge Hotels, Inc. v. Durga, LLC , 2018 WL 5307809 (D. NJ, 10/26/2018). Defendant was a franchisee of plaintiff. Defendant ceased operating and plaintiff filed suit for damages for breach of contract. Plaintiff ultimately received a default judgment. Defendant now seeks relief from that judgment. He argued his failure to defend was excusable because he was traveling the world searching for experimental medical treatments for their daughter who suffers from a rare anoxic brain injury which worsened about the time of the lawsuit. Per defendant, this search “consumed” his life. The court granted the relief, noting that the defendant’s inattention to the lawsuit was excusable given the daughter’s illness.

Eminent Domain 9. North Carolina Dept. of Transportation v. Laxmi Hotels, Inc. , 2018 WL 2207793 (05/15/2018). Defendant operates a Super 8 Motel. The Department of Transportation (DOT) sought to widen and improve the street on which the hotel was located. As a result of the work, the hotel lost several parking spaces. Also, due to a 15-foot tall retaining wall installed, visibility of the facility from the nearby thoroughfares was totally lost. The DOT claims it explained the extent of the work to be performed. The hotel’s president stated the DOT assured him the hotel would not lose any parking spaces and failed to explain the height of the retaining wall. As a result of the lost parking and street visibility, the hotel claims the DOT significantly underpaid for the taking since the loss of parking and visibility severely impacted the value of the hotel. The court agreed that the DOT did not adequately inform the hotel of the extent of the taking of hotel property. The court thus ordered the DOT to provide just compensation. The case was remanded for further calculation of appropriate reimbursement for the hotel.

Employment/Actual Employer 10. Frey v. Hotel Coleman, et al , 2018 WL 4327310 (7th Cir., 2018). Plaintiff worked at a Holiday Inn Express in Algonquin, Illinois. The hotel was owned by Hotel Coleman, Inc. which hired Vaughn Hospitality, Inc. to manage the facility. Vaughn Hospitality consisted of Michael Vaughn and his wife. Plaintiff’s paychecks came from Hotel Coleman; she was trained, supervised, evaluated, assigned, etc. by Vaughn Hospitality. Plaintiff claimed Michael Vaughn sexually harassed her and she filed a claim with the EEOC. She was thereafter fired and sued Hotel Coleman and Vaughn Hospitality for retaliatory discharge. The lower court determined Vaughn Hospitality was not plaintiff’s employer and dismissed the charges against it. Following trial against Hotel Coleman, plaintiff appealed Vaughn Hospitality’s dismissal. The appeals court reviewed several factors to consider when determining who is an employer, the most important being the right to control and supervise the worker. The court vacated the ruling that Vaughn Hospitality was not a joint employer and remanded the case. In doing so the court commented that the district court will “likely” conclude that Vaughn Hospitality was plaintiff’s employer.

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KAREN MORRIS (585) 256-0160 [email protected]

Karen Morris is an elected Town Justice in Brighton New York, a Professor of Law at Monroe Community College (MCC), and an author. She was elevated to the title of Distinguished Professor, awarded by the Chancellor of the State University of New York.

She has written several textbooks including numerous editions of Hotel, Restaurant and Travel Law, the latest of which was published in 2017 by Kendall Hunt and won a Textbook Excellence Award from Text and Academic Authors Association. She also wrote two editions of New York Cases in Business Law for Cengage Publishing. In 2011, she published Law Made Fun through Harry Potter’s Adventures, and in 2017, Law Made Fun through Downton Abbey. She also co-authors Criminal Law in New York, a treatise for lawyers. She writes a column for Hotel Management Magazine entitled, Legally Speaking, and a blog for Cengage Publishing Company on the law underpinning the news.

Among the courses she has taught are Hotel and Restaurant Law, Business Law I and II, Constitutional Law, Movies and the Law, “The Michael Jackson Trial” and “O.J. Simpson 101; Understanding Our Criminal Justice System.” Her course offerings include some in traditional classroom settings and others online. She won the Excellence in Teaching Award in 1994, having been selected by her peers, and the Chancellor’s Award for Teaching Excellence in 2002, conferred by the Chancellor of the State University of New York.

DIANA S. BARBER (404) 822-0736 [email protected] [email protected]

Diana S. Barber, J.D., CHE, CWP is currently an adjunct professor teaching hospitality law and hospitality human resource management at Georgia State University in Atlanta, GA. In addition, she conducts a one-day workshop on contracting and risk management for the Events and Meeting Planning Certificate Program offered by The University of Georgia in Athens, Georgia.

In 2017, Diana became a co-author of Hospitality Law, Managing Legal Issues in the Hospitality Industry (5th Edition), along with Stephen Barth. Ms. Barber is a recipient of the J. Mack Robinson College of Business Teaching Excellence Award in 2011 and was awarded 2011 Study Abroad Program Director of the Year by Georgia State University. In addition, Ms. Barber is the recipient of the 2010 Hospitality Faculty of the Year award and in 2012, received a Certificate of Recognition from the Career Management Center for the J. Mack Robinson College of Business. Ms. Barber is a member of Phi Beta Delta, an honor society for international scholars. Diana also completed her certification as a Certified Wedding Planner through the nationally recognized [the] Bridal Society.

Ms. Barber has recently launched a consulting/speaking company called LodgeLaw Consulting using her combined academic and hospitality legal skills; specializing in providing education to hospitality companies on preventative measures to reduce legal exposure, as well as a full range of legal services to hotels, motels, restaurants, event planning companies and private clubs. She has over thirty years of legal hospitality experience. Diana began her law practice as an associate attorney at King & Spalding in Atlanta, Georgia after graduating cum laude from Walter F. George School of Law at Mercer University in Macon, Georgia. She then spent over fourteen years with The Ritz-Carlton Hotel Company, LLC serving as vice president and associate general counsel. She is a member of the State Bar of Georgia, G.A.H.A., and the Georgia Hotel & Lodging Association (“GHLA”).

"For 22 years as Brighton Town Judge I have enforced the law, applying the rules without favor. As a judge, I blend fairness, impartiality, diligence, caring and firmness in all my decisions. Like you I am concerned about the safety of our community, the future of our young people, and the wellbeing of our residents. To those ends, I hold convicted defendants accountable, and for nonviolent offenders I include mandatory rehabilitation programs to help eliminate repeat criminal behavior" Additionally,

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Legal Considerations in Genetic Screening and Testing: Three Case Studies

• Committee Opinion CO
• Number 805
• April 2020

Recommendations and Conclusions

Case number 1. genetic testing and its effect on future insurability, case number 2. familial cancer syndrome and privacy, case number 3. findings of consanguinity on prenatal testing results.

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Number 805 (Reaffirmed 2024)

Committee on Genetics

This Committee Opinion was developed by the American College of Obstetricians and Gynecologists’ Committee on Genetics in collaboration with committee members Steven J. Ralston, MD, MPH, and Susan D. Klugman, MD, with consultation from Judith Daar, JD.

ABSTRACT: The rapidly evolving genetic technologies that are available to patients and obstetrician–gynecologists have transformed the practice of clinical medicine. From cell-free DNA screening technologies in pregnancy to expanded carrier screening and hereditary cancer gene panels, obstetrician–gynecologists often are faced with questions about their legal responsibilities regarding genetic information as well as the legal ramifications of this information for their patients. The Committee on Genetics has constructed the following case studies to highlight some of the legal issues an obstetrician–gynecologist may encounter when performing genetic testing. These cases do not cover the breadth of legal issues affecting clinical genetics, but rather they illustrate certain legal concepts and principles as well as key pieces of legislation that are pertinent to clinical care. These case descriptions are not intended to serve as legal advice. Obstetrician–gynecologists are strongly encouraged to seek expert legal assistance to resolve questions involving legal rights or responsibilities.

Legal and ethical requirements protect the identity of a patient’s confidential information. Under these requirements, a patient’s health information (including genetic diagnoses) should be kept confidential; however, if a patient gives you permission to reveal this information, you may do so to counsel the relevant family members.

Obstetrician–gynecologists should not withhold information from a patient regarding her health, including test results, and have a responsibility to disclose such information, especially when it is of potential relevance to decision making.

Obstetrician–gynecologists are encouraged to seek guidance from an ethics committee, an attorney, or both, before deciding whether to reveal genetic information to or withhold it from family members who may be at risk.

Many prenatal genetic tests have the potential to reveal information about the patient and her family that is unexpected or unsuspected and that was not part of the original intent for testing. Such results often raise complex ethical and legal issues and may require consultation with a genetics professional, ethicist, or legal counsel.

The rapidly evolving genetic technologies that are available to patients and obstetrician–gynecologists have transformed the practice of clinical medicine. From cell-free DNA screening technologies in pregnancy to expanded carrier screening and hereditary cancer gene panels, obstetrician–gynecologists often are faced with questions about their legal responsibilities regarding genetic information as well as the legal ramifications of this information for their patients.

The Committee on Genetics has constructed the following case studies to highlight some of the legal issues an obstetrician–gynecologist may encounter when performing genetic testing. These cases do not cover the breadth of legal issues affecting clinical genetics, but rather they illustrate certain legal concepts and principles as well as key pieces of legislation that are pertinent to clinical care. These case descriptions are not intended to serve as legal advice. Obstetrician–gynecologists are strongly encouraged to seek expert legal assistance to resolve questions involving legal rights or responsibilities.

A 24-year-old patient sees you for BRCA1 testing because her mother has breast cancer and was found to be BRCA1 positive. The patient is worried that if she tests positive she may have difficulty obtaining health, life, or disability insurance. She also is concerned that her employer may fire her because of concerns that if she develops breast cancer, premiums will increase for all employees.

Some of this patient’s concerns are well founded, although others are not. The Genetic Information and Nondiscrimination Act (known as GINA) of 2008 is a federal law that prevents health insurance carriers from using or requesting genetic information to make decisions about coverage, premiums, or eligibility. The Patient Protection and Affordable Care Act of 2012 went further and protected individuals with preexisting conditions (a BRCA1 pathogenic variant, a new term for what was formerly referred to as a “mutation,” would fall into this category) from losing their health insurance or facing exorbitant premiums. This patient’s ability to obtain health insurance would not be affected by a positive BRCA1 test because of GINA, and the Patient Protection and Affordable Care Act would protect her eligibility (and premiums) if she developed cancer. Nevertheless, this mandated coverage of preexisting conditions is dependent on the survival of the Patient Protection and Affordable Care Act or its replacement with legislation or regulations that include similar protections.

It is critical, however, for her to understand that these protections do not extend to other forms of insurance, such as life, disability, and long-term care insurance. The Genetic Information and Nondiscrimination Act only will protect her from employment discrimination if her employer discovers the results of her genetic testing if she works for an organization of more than 15 employees. Smaller companies are excluded from this prohibition.

These insurance and employment issues, along with the medical complexities of genetic testing, highlight the role and value of trained genetic counselors and genetics practitioners in helping patients make these difficult screening and testing decisions.

Patient A is a 34-year-old new patient in your practice. Her sister, patient B, also is in your practice. In taking patient A’s medical history, she tells you that she recently had a colectomy because of extensive polyposis. She was found to have the APC gene associated with autosomal dominant familial adenomatous polyposis syndrome, one of several hereditary cancer syndromes. When taking the family history, she tells you that her father died of colon cancer at 48 years of age. You think you should reveal the information about her APC pathogenic variant to her sister because she has a 50% chance of being a carrier as well and may want to have genetic screening for this colon cancer syndrome.

Legal and ethical requirements protect the identity of a patient’s confidential information. Under these requirements, a patient’s health information (including genetic diagnoses) should be kept confidential; however, if a patient gives you permission to reveal this information, you may do so to counsel the relevant family members. The case becomes challenging when the affected patient does not give permission to reveal her test result. Thus, if patient A did not give you permission to disclose, you could discuss the family history and its implications with patient B, but you could not discuss patient A’s APC pathogenic variant.

The Health Insurance Portability and Accountability Act of 1996, (known as HIPAA), is relevant in this situation. The rules set out in HIPAA and in associated regulations protect the privacy of individually identifiable health information, including the genetic test result discussed in this case. Physicians and others who are covered by HIPAA are prohibited from disclosing protected health information to third parties (in this case the sister) without written authorization from the patient 1 . The Health Insurance Portability and Accountability Act contains some limited exceptions permitting disclosure when the covered entity has a good faith belief that the disclosure 1) is necessary to prevent or lessen a serious and imminent threat to the health or safety of a person or the public, and 2) is to a person reasonably able to prevent or lessen that threat. Whether this exception to the privacy rule would include disclosure of genetic test results to a potentially affected family member is uncertain but seems unlikely except in very limited circumstances in which the threat is both imminent and preventable. To date, there are no published judicial opinions addressing the application of the HIPAA privacy exception to unauthorized disclosure of an inheritable risk of disease.

To be clear, before the enactment of HIPAA, disclosing patients’ personal health information did have legal ramifications; however, these ramifications usually were addressed by litigation brought by the patient, including negligence claims for a breach of confidentiality. Although HIPAA did not make these torts disappear, it added federal civil monetary and criminal penalties to the consequences of inappropriate disclosure of patients’ confidential information.

In addition to HIPAA, there are some relevant court cases dealing with personal health information and a so-called “duty to warn.” For example, in Tarasoff v. Regents of the University of California 2 , the court concluded that a psychologist has a duty to breach patient confidentiality and take reasonable actions to protect an individual who is in danger of harm by the psychologist’s client. Does patient B’s potential to have familial adenomatoid polyposis syndrome constitute the kind of clear and imminent threat that was described in Tarasoff and other subsequent cases? It seems unlikely that the Tarasoff case would support a disclosure of patient A’s confidential information to patient B. Patient B’s potential to have familial adenomatoid polyposis is a risk distinguishable from the specific threats made by the patient in the Tarasoff case.

In Pate v. Threlkel 3 , the court found that a physician has the duty to warn a patient regarding the risk to her children from her inheritable form of cancer, and that the physician owes that duty both to the patient and to her children. Similarly, Safer v. Estate of Pack 4 found that a physician has a duty to a patient and to family members to warn of “avertible risk from genetic causes;” however, unlike in the Pate case, the court declined to state whether the physician can satisfy this duty by warning the patient or whether the physician must warn the family members. Obstetrician–gynecologists are encouraged to seek guidance from an ethics committee, an attorney, or both, before deciding whether to reveal genetic information to or withhold it from family members who may be at risk. In this case, however, disclosure may be unnecessary and can be avoided as the physician could easily offer genetic testing to patient B in light of a family history of colon cancer at a young age.

A 35-year-old patient undergoes amniocentesis and the karyotype is reported as 46, XY, but the chromosomal microarray shows areas of homozygosity, which strongly suggests parental consanguinity. Are you legally obligated to reveal this information to the patient and what should be discussed?

Obstetrician–gynecologists should not withhold information from a patient regarding her health, including test results, and they have a responsibility to disclose such information, especially when it is of potential relevance to decision making. However, many prenatal genetic tests have the potential to reveal information about the patient and her family that is unexpected or unsuspected and was not part of the original intent for testing. Such results often raise complex ethical and legal issues and may require consultation with a genetics professional, ethicist, or legal counsel. Often, the clinical report or a discussion with the laboratory can provide more information to help in counseling the patient. In this case, the degree of homozygosity could reveal how closely the parents are related by blood.

In this case, the test result may have important implications regarding the health of the fetus and may have implications for future pregnancies. It is necessary to inform the patient of this finding and to consider the specific areas of homozygosity and the potential genes that may be involved. The possible risk of autosomal recessive conditions in the fetus should be discussed with the patient. In addition, if large areas of homozygosity are found, this test result may imply a close blood relationship, such as that seen with incestuous relationships. It may be necessary to have a discussion with the patient if you suspect that she is a survivor of incestuous rape. Obstetrician–gynecologists are encouraged to use other American College of Obstetricians and Gynecologists’ documents, including Committee Opinion No. 777 Sexual Assault 5 and Committee Opinion No. 518 Intimate Partner Violence 6 for further resources.

Adequate pretest counseling and screening, including an extensive family history, may help to avoid discovering information unexpectedly. Patients should be made aware that information about blood relatedness may be revealed by some prenatal genetic tests. Because of the complex genetic, ethical, and legal implications of discovering such information, it will often be prudent to involve a genetic counselor, genetics professional, ethics consultant, or legal expert in caring for these patients.

The choice to perform genetic testing can have legal ramifications for patients and physicians. Patients require informed consent before these tests, and obstetrician–gynecologists could consider using genetic counselors or other practitioners trained in genetics when performing tests that are not routine or that require complex pretest or posttest counseling. Legal requirements may differ across the jurisdictions in which health care providers practice, and obstetrician–gynecologists should reach out to local ethics committees or to attorneys familiar with these issues when questions arise or counsel is necessary.

• Uses and disclosures for which an authorization is required, 45 C.F.R. § 164.508 (2018). Available at: https://www.govinfo.gov/content/pkg/CFR-2018-title45-vol1/pdf/CFR-2018-title45-vol1-sec164-508.pdf . Retrieved December 17, 2019. Article Locations: Article Location
• Tarasoff v. the Regents of the University of California. 551 P.2d 334 (Cal 1976). Article Locations: Article Location
• Pate v. Threlkel. 661 So.2d 278 (Fla. 1995). Article Locations: Article Location
• Safer v. Estate of Pack. 291 N.J. Super. 619, 677 A.2d 1188 (N.J. 1996). Article Locations: Article Location
• Sexual assault. ACOG Committee Opinion No. 777. American College of Obstetricians and Gynecologists. Obstet Gynecol 2019; 133: e296– 302. Article Locations: Article Location
• Intimate partner violence. ACOG Committee Opinion No. 518. American College of Obstetricians and Gynecologists. Obstet Gynecol 2012; 119: 412– 7. Article Locations: Article Location

Published online on March 26, 2020.

Copyright 2020 by the American College of Obstetricians and Gynecologists. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, posted on the internet, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission from the publisher.

American College of Obstetricians and Gynecologists 409 12th Street SW, Washington, DC 20024-2188

Legal considerations in genetic screening and testing: three case studies. ACOG Committee Opinion No. 805. American College of Obstetricians and Gynecologists. Obstet Gynecol 2020;135:e189–92.

This information is designed as an educational resource to aid clinicians in providing obstetric and gynecologic care, and use of this information is voluntary. This information should not be considered as inclusive of all proper treatments or methods of care or as a statement of the standard of care. It is not intended to substitute for the independent professional judgment of the treating clinician. Variations in practice may be warranted when, in the reasonable judgment of the treating clinician, such course of action is indicated by the condition of the patient, limitations of available resources, or advances in knowledge or technology. The American College of Obstetricians and Gynecologists reviews its publications regularly; however, its publications may not reflect the most recent evidence. Any updates to this document can be found on acog.org or by calling the ACOG Resource Center.

While ACOG makes every effort to present accurate and reliable information, this publication is provided “as is” without any warranty of accuracy, reliability, or otherwise, either express or implied. ACOG does not guarantee, warrant, or endorse the products or services of any firm, organization, or person. Neither ACOG nor its officers, directors, members, employees, or agents will be liable for any loss, damage, or claim with respect to any liabilities, including direct, special, indirect, or consequential damages, incurred in connection with this publication or reliance on the information presented.

All ACOG committee members and authors have submitted a conflict of interest disclosure statement related to this published product. Any potential conflicts have been considered and managed in accordance with ACOG’s Conflict of Interest Disclosure Policy. The ACOG policies can be found on acog.org . For products jointly developed with other organizations, conflict of interest disclosures by representatives of the other organizations are addressed by those organizations. The American College of Obstetricians and Gynecologists has neither solicited nor accepted any commercial involvement in the development of the content of this published product.

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Business Law Case Studies with Solutions

• Post author: myspeakhr
• Post category: Case Study
• Reading time: 5 mins read

Discussed here is the Business Law Case Studies with Solutions. Business Law is also known as Legal Aspects of Business, Commercial Law etc. Here we have given short case studies along with solutions in business law. These simple case law in commercial law contains cases related to Contract Act 1872, Sale of goods Act and Consumer protection Act with solutions. All the 3 Acts discussed here is majorly used in business transactions. These short case studies on commercial law with answers will be helpful for students of MBA, BBA, B.com and Law. These case studies and solutions are explained in very simple words without much difficult legal terms for the benefit of the students.

Below is the Business Law Case Studies with Solutions.

I. Indian Contract Act Case Studies

1. case study on basic contract act.

“A gives an offer in the newspaper for the sale of his HP laptop for Rs. 15000. He also stated that Those who are willing to purchase can send a message to his mobile.”” In this simple case consider the following situation and discuss the solution:

a) B was interested to purchase the laptop and sent a message stating that he wish to purchase for 12000. Was it an acceptance is given by B-

No it was not an acceptance It can be termed as counter offer. If feasible A has to give acceptance.

b) B was interested to purchase the same but he asked C to message on behalf of B. and C messaged as follows

“My friend B is interested to purchase your laptop for 15000”  . Here is this a valid Acceptance? is A binded by the acceptance.

No this is not a valid acceptance. The acceptance needs to be given by the accept-or itself. Hence A is not binded by the action of C.

c)  B who is much interested in purchasing the laptop had called Mr.A and given the acceptance through his phone. Is A obliged for acceptance given by B.

The acceptance must the given by the mode prescribed by the offer-or only. Hence in the given case the acceptance given by B through telephone is not an acceptance.

2. Case study on Valid Contract

Mr. X invited Mr. Y his business partner for X’s sisters marriage. Y accepted the invitation in this ground X booked a table in a costly hotel where the marriage takes place. Due to some reason Y could not attend the function. What type of contact is this. Is this a valid contract. Justify your answer.

This is not a valid contract on the following basis:

a. This is a social agreement. The agreement is not created with an intention to create legal relationship rather to create a social relationship.

b. There is no consideration involved in the contract hence it is not a valid contract.

II. Consumer Protection Act Case Studies

3. case study on who is a consumer.

a. Mr. A bought a printer from an electronics store for using it at home. The TV was defective. Is Mr. A a consumer?

Yes Mr. A is a consumer as he purchased the printer for his own use.

b. Balu is a distributor for computer accessories. He bought 100 pen-drives for selling to other computer vendors. Is Balu a consumer?

Balu is not a consumer as he has obtained accessories for resale.

4. Case study on Restrictive and Unfair trade practices

Mr. X went to a electronic shop to purchase a TV for his newly built house. He asked the information about Samsung 40 inches LED TV to the shop keeper. The shop keeper being a dealer of other brands misguide the customer stating that Samsung had planned to stop the production of 40 Inch LED TV’s. The shopkeeper made the customer believed the same and advice him to purchase some other brand.

The act of Shop keeper is Restrictive trade practice or Unfair trade practices?

The act of shopkeeper is a unfair trade practice as he had mislead the customer with a motive to increase his sale.

III. Sale of Goods Act 1930 Case studies

5. case study on sale or agreement to sell.

On 1st March 2017, Alex agreed to sell his car to Beny for Rs. 80,000. It was agreed between themselves that the ownership of the car will transfer to B on 31st March 2017. when the car is gets registered in Beny`s name. Justify whether it is sale or agreement to sell.

It is an agreement to sell and it will become sale on 31st March when the car is registered in the name of Beny.

6. Case study on Warranty

Anay purchased a second hand typewriter from Balu. Anay used it for sometime and also spend some money on its repairs. The typewriter turned out to be stolen one and as such Anay had to return it to the true owner chand. Is it a breach of Warranty or not. What remedy will Anay get?.

It is a breach of warranty. It is a implied warranty as to quite possession. It was held that Anay could recover damages from Balu amounting to the price paid and the cost of repair.

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• purpose of information management
• proffesionals ethics in information management
• standards in information management 14 hrs
• meaning of standards in information management
• purpose standards in information management
• sources of standards in information management
• standards in library inrecords and archives information systems
• standards in library and information systems
• standards in electronics information management
• emerging issues and trends 6hrs
• emerging issues and trends
• challenges posed by emerging trends issues and trends
• ways of coping with the emerging issues and trends

Intellectual property law

What is Intellectual Property?

Intellectual property refers to creations of the mind: inventions; literary and artistic works; and symbols, names and images used in commerce.

Intellectual property is divided into two categories:

• Industrial Property includes patents for inventions, trademarks, industrial designs and geographical indications.
• Copyright covers literary works (such as novels, poems and plays), films, music, artistic works (e.g., drawings, paintings, photographs and sculptures) and architectural design.

Rights related to copyright include those of performing artists in their performances, producers of phonograms in their recordings, and broadcasters in their radio and television programs.

What are intellectual property rights?

Intellectual property rights are like any other property right.

• They allow creators, or owners, of patents, trademarks or copyrighted works to benefit from their own work or investment in a creation.

Protect intellectual property?

There are several compelling reasons.

• The progress and well-being of humanity rest on its capacity to create and invent new works in the areas of technology and culture.
• The legal protection of new creations encourages the commitment of additional resources for further innovation.
• The promotion and protection of intellectual property spurs economic growth, creates new jobs and industries, and enhances the quality and enjoyment of life.
• An efficient and equitable intellectual property system can help all countries to realize intellectual property’s potential as a catalyst for economic development, social and cultural well-being.
• The intellectual property system helps strike a balance between the interests of innovators and the public interest, providing an environment in which creativity and invention can flourish, for the benefit of all.

 benefit from  intellectual property

• Intellectual property rights reward creativity and human endeavor, which fuel the progress of humankind. Some examples: The multibillion dollar film, recording, publishing and software industries – which bring pleasure to millions of people worldwide – would not exist without copyright protection.
• Without the rewards provided by the patent system, researchers and inventors would have little incentive to continue producing better and more efficient products for consumers.
• Consumers would have no means to confidently buy products or services without reliable, international trademark protection and enforcement mechanisms to discourage counterfeiting and piracy.

PATENT LEGISLATION

A patent is an exclusive right granted for an invention –a product or process that provides a new way of doing something, or that offers a new technical solution to a problem. A patent provides patent owners with protection for their inventions. Protection is granted for a limited period, generally 20 years.

IMPORTANT OF PATENTS

• Patents provide incentives to individuals by recognizing their creativity and offering the possibility of material reward for their marketable inventions.
• Encourage innovation, which in turn enhances the quality of human life.

WHAT KIND OF PROTECTION DO PATENTS OFFER?

• Patent protection means an invention cannot be commercially made, used, distributed or sold without the patent owner’s consent.
• Patent rights are usually enforced in courts that, in most systems, hold the authority to stop patent infringement.
• Conversely, a court can also declare a patent invalid upon a successful challenge by a third party.

WHAT RIGHTS DO PATENTOWNERS HAVE?

• A patent owner has the right to decide who may – or may not – use the patented invention for the period during which it is protected.
• Patent owners may give permission to, or license, other parties to use their inventions on mutually agreed terms.
• Owners may also sell their invention rights to someone else, who then becomes the new owner of the patent. Once a patent expires, protection ends and the invention enters the public domain.
• This is also known as becoming off patent, meaning the owner no longer holds exclusive rights to the invention, and it becomes available for commercial exploitation by others.

What role do patents play in everyday life?

• Patented inventions have pervaded every aspect of human life, from electric lighting (patents held by Edison and Swan) and sewing machines (patents held by Howe and Singer), to magnetic resonance imaging (MRI) (patents held by Damadian) and the iPhone (patents held by Apple).
• In return for patent protection, all patent owners are obliged to publicly disclose information on their inventions in order to enrich the total body of technical knowledge in the world.
• This ever increasing body of public knowledge promotes further creativity and innovation.
• Patents therefore provide not only protection for their owners but also valuable information and inspiration for future generations of researchers and inventors.

SHORT FALL OF PATERN ACT

• Hindered local research and ignored the protection of indigenous intellectual property right
• The law greatly retarded and affected the country’s independent technology development.
• It solely support the registration of foreign pattern in Kenya
• It maintained a close link wit british patern regulation which had no provisions for Kenya needs such as protection of right of kenya’s intellectual property

CHALLENGE /FACTOR THAT HINDERS PATERN IMPLENTATION

• Opposition procedures towards the licesing of patern use in territory apart from revoking the patern on the ground of manufacture,
• Uses or sale of invention before the priority date applicable to the patern
• There was no state agency dealing with the assessment and evaluation of the novelty of an invention requiring patenting
• The law act provision for compulsory licensing and no restrictions were imposed on licensing in general.

How is a patent granted?

The first step in securing a patent is to

• file a patent application. The application generally contains the title of the invention, as well as an indication of its technical field.
• It must include the background and a description of the invention, in clear language and enough detail that an individual with an average understanding of the field could use or reproduce the invention. Such descriptions are usually accompanied by visual materials – drawings, plans or diagrams – that describe the invention in greater detail.
• The application also contains various “claims”, that is, information to help determine the extent of protection to be granted by the patent.

What kinds of inventions can be protected?

An invention must, in general, fulfill the following conditions   to be protected by a patent.

• It must be of practical use; it must show an element of “novelty”, meaning some new characteristic that is not part of the body of existing knowledge in its particular technical field. That body of existing knowledge is called “prior art”.
• The invention must show an “inventive step” that could not be deduced by a person with average knowledge of the technical field.
• Its subject matter must be accepted as “patentable” under law. In many countries, scientific theories, mathematical methods, plant or animal varieties, discoveries of natural substances, commercial methods or methods of medical treatment (as opposed to medical products) are not generally patentable.

 TRADEMARK LEGISLATION

is a distinctive sign that identifies certain goods or services produced or provided by

an individual or a company. Its origin dates back to ancient times when craftsmen reproduced their signatures, or “marks”, on their artistic works or products of a

Functional or practical nature. Over the years, these marks have evolved into today’s system of

Trademark registration and protection.

The system helps consumers to identify and purchase a product or service based on whether its specific characteristics and quality – as indicated by its unique trademark– meet their needs.

WHAT DO TRADEMARKS DO?

Trademark protection ensures that owners of marks have the exclusive right to

• use them to identify goods or services, or to authorize others to use them in return for payment.
• The period of protection varies, but a trademark can be renewed indefinitely upon payment of the corresponding fees.
• Trademark protection is legally enforced by courts that, in most systems, have the authority to stop trademark infringement.
• Trademarks promote initiative and enterprise worldwide by rewarding their owners with recognition and financial profit.
• Trademark protection also hinders the efforts of unfair competitors, such as counterfeiters, to use similar distinctive signs to market inferior or different products or services.
• The system enables people with skill and enterprise to produce and market goods and services in the fairest possible conditions, thereby facilitating international trade.

What kinds of trademarks can be registered?

Trademarks may be one or a combination of words, letters and numerals.

They may consist of drawings, symbols or three dimensional

signs, such as the shape and packaging of goods.

In some countries, non-traditional marks may be registered for distinguishing features such as

holograms, motion, color and non-visible signs (sound, smell or taste).

In addition to identifying the commercial source of goods or services, several other trademark categories also exist. Collective marks are owned by an association  whose members use them to

indicate products with a certain level of quality and who agree to adhere to specific requirements

set by the association. Such associations might represent, for example, accountants, engineers

or architects. Certification marks are given for compliance with defined standards but are not confined to any membership.

They may be granted to anyone who can certify that their products  meet certain established standards. Some examples of recognized certification are the internationally accepted “ISO 9000” quality standards and Ecolabels for products with reduced environmental impact.

How is a trademark registered?

• First, an application for registration of a trademark must be filed with the appropriate national or regional trademark office. The application must contain a clear reproduction of the sign filed for registration, including any colors,forms or three-dimensional features.
• It must also contain a list of the goods or services to which the sign would apply. The sign must fulfill certain conditions in order to be protected as a trademark or other type of mark.
• It must be distinctive, so that consumers can distinguish it from trademarks identifying other products, as well as identify a particular product with it.
• It must neither mislead nor deceive customers nor violate public order or morality.
• Finally, the rights applied for cannot be the same as, or similar to, rights already granted to another trademark owner. This may be determined through search and examination by national offices, or by the opposition of third parties who claim to have similar or identical rights.

How extensive is trademark protection?

Almost all countries in the world register and protect trademarks. Each national or regional office maintains a Register of Trademarks containing full application information on all

Registrations and renewals, which facilitates examination, search and potential opposition by third parties.

• The effects of the registration are, however, limited to the country (or, in the case of regional registration, countries) concerned.
• To avoid the need to register separate applications with each national or regional office, (or related region), obtain an international registration having effect in some or all of the other countries of the Madrid Union

NATURE OF COPYRIGHT AND RELATED RIGHTS

Copyright laws grant authors, artists and other creator’s protection for their literary and artistic

creations, generally referred to as “works”. A closely associated field is “related rights” or rights related to copyright that encompass rights similar or identical to those of copyright, although sometimes more limited and of shorter duration. The beneficiaries of

related rights are:

• performers (such as actors and musicians) in their performances; producers of phonograms (for example, compact discs) in their sound recordings; and broadcasting organizations in their radio and television programs.

Works covered by copyright

include, but are not limited to:

• novels, poems, plays, reference works, newspapers, advertisements, computer programs, databases, films, musical compositions, choreography, paintings, drawings, photographs, sculpture, architecture, maps and technical draw

What rights do copyright and related rights provide?

• The creators of works protected by copyright, and their heirs and successors (generally referred to as “right holders”), have certain basic rights under copyright law.
• They hold the exclusive right to use or authorize others to use the work on agreed terms.
• The right holder(s) of a work can authorize or prohibit: its reproduction in all forms, including print form and sound recording; its public performance and communication to the public; its broadcasting; its translation into other languages; and its adaptation, such as from a novel to a screenplay for a film. Similar rights of, among others, fixation (recording) and reproduction are granted under related rights.
• Many types of works protected under the laws of copyright and related rights require mass distribution, communication and financial investment for their successful dissemination (for example, publications, sound recordings and films). Hence,
• Creators often transfer these rights to companies better able to develop and market the works, in return for compensation in the form of payments and/or royalties (compensation based on a percentage of revenues generated by the work). The economic rights relating to copyright are of limited duration – as provided for in the relevant WIPO treaties – beginning with the creation and fixation of the work, and lasting for not less than 50 years after the creator’s death. National laws may establish longer terms of protection.
• This term of protection enables both creators and their heirs and successors to benefit financially for a reasonable period of time. Related rights enjoy shorter terms, normally 50 years after the performance, recording or broadcast has taken place.
• Copyright and the protection of performers also include moral rights, meaning the right to claim authorship of a work, and the right to oppose changes to the work that could harm the creator’s reputation.
• Enforced by right holders through a variety of methods and fora, including civil action suits, administrative remedies and criminal prosecution. Injunctions, orders requiring destruction of infringing items, inspection orders, among others, are used to enforce these rights.

What are the benefits of protecting copyright and related rights?

• Copyright and related rights protection is an essential component in fostering human creativity and innovation. Giving authors, artists and creators incentives in the form of recognition and fair economic reward
• Increases their activity and output and can also enhance the results.
• By ensuring the existence and enforceability of rights, individuals and companies can more easily invest in the creation, development and global dissemination of their works.
• This, in turn, helps to increase access to and enhance the enjoyment of culture, knowledge and entertainment the world over, and also stimulates economic and social development.

How have copyright and related rights kept up with advances in technology?

The field of copyright and related rights has expanded enormously during the last several decades with the spectacular progress of technological development that has, in turn, yielded new ways of disseminating creations by such forms of communication as satellite

broadcasting, compact discs and DVDs. Widespread dissemination of works via the Internet raises difficult questions concerning copyright and related rights in this global medium. WIPO is fully involved in the ongoing international debate to shape new standards for copyright protection in cyberspace. In that regard, the Organization administers the WIPO Copyright Treaty (WCT) and the WIPO Performances and Phonograms Treaty (WPPT), known as the “Internet Treaties”. These treaties clarify international norms aimed at preventing unauthorized access to and use of creative works on the Internet.

How are copyright and related rights regulated?

Copyright and related rights protection is obtained automatically without the need for registration or other formalities. However, many countries provide for a national system of optional registration and deposit of works. These systems facilitate, for example, questions involving disputes over ownership or creation, financial transactions, sales, assignments and transfer

of rights. Many authors and performers do not have the ability or means to pursue the legal and administrative enforcement of their copyright and related rights, especially given the increasingly global use of literary, music and performance rights. As a result, the establishment and enhancement of collective management organizations (CMOs), or “societies”, is a growing and necessary trend in many countries.

These societies can provide their members with efficient administrative support and legal expertise in, for example, collecting, managing and disbursing royalties gained from the national and international use of a work or performance. Certain rights of producers of sound recordings and broadcasting organizations are sometimes managed collectively as well.

BOOK S AND NEWSPAPER ACT

• Ensure comprehensive collection of all information materials produce in Kenya to enable appropriate bibliographic control and preparation of national bibliography
• Ensure interllectual property

LAW OF CONTRACT IN INFORMATION LEGISLATION

LEGISLATION GOVERNING INFORMATION SYSTEMS

The term legislation is made up of two part legis meaning law and lation donating the bringing of the law that into effect: thus law and its implementation.

They are laws enacted by a legislative body in an information center which are meant to be followed by the users. The term is used mainly in government proceedings or rules which have been produced by a governing body in order to regulate, to authorize, to sanction, to grant, to declare or to restrict. It defines the governing legal principles outlining the responsibilities of events organizers and other stakeholders such as the local authority to protect the safety of the public.

International Conventions relating to information System.

• Conventions for the protection of industrial property rights signed in Paris on 20 March 1883, as last revised on 14 July 1967 (Paris Conventions)
• Berne Convention for the presentation n of literary and artistic words.
• Convention establishing the world intellectual property organization (WIPO)
• Patent Corporation Treaty.
• Convention on the Grant of European Patent

The subject that these Conventions seek to regulate is the activity of governments to ensure international information security.

The aim of this Convention is to act against the use of information and communication technology to violate international peace and security, as well as to set up measures ensuring that the activity of governments in the information space will:

• Further general social and economic development;
• Be carried out in such a way as to be compatible with efforts to support international peace and security;
• Correspond to generally accept ed principles and norms of international law, including principles of peacefully regulating conflicts and disagreements, abstaining from the use of force, not interfering in internal issues, and respecting fundamental human rights and freedoms;
• Be compatible with the right of each individual to seek, receive, and distribute information and ideas, as is affirmed in UN documents, while keeping in mind that this right may be restricted through legislation to protect the national and social security of each State, as well as to prevent the wrongful use of and unsanctioned interference in information resources;
• Guarantee the free exchange of technology and information, while maintaining respect for the sovereignty of States and their existing political, historical, and cultural specificities.

The following terms and definitions are used for this information legislation

Access to information is the possibility of receiving and using information.

Information security is a state in which personal interests, society, and the government are protected against the threat of destructive actions and other negative actions in the information space.

Information warfare is conflict between two or more states in the information space with the goal of inflicting damage to information systems, processes, and resources, as well as to critically important structures and other structures; undermining political, economic, and social systems; carrying out mass psychological campaigns against the population of a State in order to destabilize society and the government; as well as forcing a State to make decisions in the interests of their opponents.

Information infrastructure is the total complex of technical means and systems of the formation, conversion, transfer, use, and storage of information.

Information system is the total amount of information stored in a database and the technology used to support the processing of that information.

Information weapon is information technology, means, and methods intended for use in information warfare.

Information space is the sphere of activity connected with the formation, creation, conversion, transfer, use, and storage of information and which has an effect on individual and social consciousness, the information infrastructure, and information itself.

Information and communication technologies is the total amount of methods, production processes, and programming and technical elements, integrated with the goal of forming, converting, transferring, using, and storing information.

Information resource is an information infrastructure, as well as the information itself and the flow of that information.

Confidentiality of information is the mandatory requirement that a party granted access to certain information will not transfer this information to a third party without the agreement of the owner.

The misuses of information resources is the use of information resources without the necessary rights, or which involves a violation of existing regulations, national legislation, or international legal norms.

Dissemination of information is an actions aimed at the receipt of information by an indefinite group, or the transfer of information to an indefinite group.

Terrorism in the information space is the use of information resources and/or activity affecting them in the information space for the purposes of terrorism.

Threats to the information space (threat to information security) are factors that pose a danger to individuals, society, and the state, and their interests, in the information space.

Purpose of information legislation in information systems

• Create the necessary library agencies
• Gurantee the establishment of a network of libraries on a statutary basis
• Ensures a stable financial support on a progressive basis
• Set up library authorities which are responsible for the staffing,administration and management of the libraries
• Ensure permanent, uniform, efficient, expanding and coordinated library service
• Presuppose free service and make it easily accessible to potential users irrespective of their qualification and age.

Law governing library and information systems

Intellectual property

Intellectual property refers to intangible creations protected by the law. Or it refers to property that is the result of creativity and does not exist in a tangible form, such as patents, copyright, trademarks.

Patent is a legal document granting owner exclusive monopoly on an invention for 17 years. Or it is a patent for an invention is the grant of a property right to the inventor. Patents are granted for new, useful and non-obvious inventions for a period of 20 years from the filing date of a patent application, and provide the right to exclude others from exploiting the invention during that period.

Copyright refers to the statutory grant protecting intellectual property from copying for 28 years.

Trademark is legally registered mark, device, or name to distinguish one’s goods.

National Information Policy

Refers to the set of rules, formal and informal, that directly restrict, encourage, or otherwise shape the flows of information.

Information Policy is the set of all public laws, regulations and policies that encourage, discourage, or regulate the creation, use, storage, access, communication and dissemination of information.

Or it is a statement of intent that helps to translate programmes objective into accomplishment by providing administrative guideline for decision making

 Information policy includes:

• Privatization and distribution of government information
• Freedom of information access
• Protection of personal privacy
• Intellectual property rights

Public policy issue: a fundamental enduring conflict among and between objectives, goals, customs, plans, activities and stakeholders, not likely to be resolved completely in favor of any polar position in that conflict, but changes in environment may require striking a fresh balance among conflicting forces from time to time.

ICT Policy: Information and Communications Technologies ( ICT ) environment is dynamic and rapid technological development is changing how we communicate and access information and services. Separate frameworks have guided the development of the Telecommunications & Postal Services sector since 1994.

Circulars policy: A government circular is a written statement of government policy. It will often provide information, guidance, rules, and/or background information on legislative or procedural matters.

Importance of information policy in a country.

• It shapes the flows of information in a country
• It directly restricts the flow of information of country
• It protects country’s information privacy
• It provides freedom of information access in a country
• It enhances the privatization and distribution of government/ county’s information.

Role of information legislation/law

• governs the extent to which citizens can gain access to information held by central Government and other public authorities.
• information law seeks to guard against the misuse of personal, private and confidential information by public authorities, employers, media organisations and others
• Information law is also becoming an increasing important facet of other specialist areas of legal practice – such as employment law, public law and business law.
• to supervise and regulate persons in the information services industry in accordance with the information Services Act and data protection legislation
• To allow regulators to assist in improving the stability an effectiveness of information services
• To allow regulators to exclude from the information  system and those who may abuse it
• To facilitate a seamless and expeditious flow of information between information sector regulators, the private sector and law enforcement agencies

National information Legislation in Kenya

National information legislation in Kenya are:

• Kenya National Library Service (KNLS) act
• Kenya National Archives and Documentation Services (KNADS) act
• Copyright law
• Information privacy.
• Newspapers and journal act
• Record disposal act
• Information access act

Kenya National Library Services Board Act (KNLS Act)

  Functions KNLS of the Board

The functions of the Board shall be:

• To promote, establish, equip, manage, maintain and develop libraries in Kenya as a National Library Service; CAP. 225 [Rev. 2012]Kenya National Library Services Board [Issue 1] 6
• To plan and co-ordinate library, documentation and related services in Kenya;
• To advise the Government, local authorities and other public bodies on all matters relating to library, documentation and related services;
• To provide facilities for the study of, and for training in the principles, procedures and techniques of librarianship and such other related subjects as the Board may from time to time decide;
• To advise the Government on library education and training needs for library, documentation and related services;
• To sponsor, arrange or provide facilities for conferences and seminars for discussion of matters in connection with library and related services;
• To carry out and to encourage research in the development of library and related services;
• To participate and assist in campaigns for the eradication of illiteracy;
• To stimulate public interest in books and to promote reading for knowledge, information and enjoyment;
• To acquire books produced in and outside Kenya and such other materials and sources of knowledge necessary for a comprehensive national library;
• To publish the national bibliography of Kenya and to provide a bibliographical and references service. [Act No. 12 of 1984, Sch.]

Public Archives and Documentation Service Act

• To provide  for  the  preservation  of  public archives and public records and for connected purposes.
• Provided that the Minister may, by order in the Gazette, amend the Schedule; “records” includes  not  only  written  records,  but  records  conveying information by any means whatsoever; “Service
• Examine  any  public  records,  and  advise  on  the  care,  preservation, custody and control thereof;
• Require  the  transfer  to  his  custody  of  any  public  records  which  he considers should be housed in the national archives;
• Compile, make  available  and  publish  indexes  and  guides  to,  and calendars and texts of, all public archives
• Prepare publications concerning the activities  of and  the  facilities provided by the Service;
• Regulate  the  conditions  under  which  members  of  the  public  may inspect the public archives or use the facilities provided by the Service;
• Provide for the making of, and authentication of, copies of and extracts from the public archives, for use as evidence in legal proceedings or for any other purpose;
• Make arrangements  for  the  separate  housing  of  films  and  other records which require to be kept under special conditions;
• Acquire, or  accept  gifts  or  testamentary  bequests  or  loans  of,  any document,  book,  record,  or  other  material  of  any  description  of

 Copyright Laws

Copyright refers to a person’s exclusive right to authorize certain acts (such as reproduction, publication, Public performance, adaptation etc.) in relation to his or her original work of authorship.

• Copyright – There’s nothing you need to do now to copyright your original work. Since 1978, the mere act of creating it makes it yours; however, you should occasionally comb the Web and perform other kinds of diligence to ensure that your copyrights are not being violated. If you find what you suspect is a violation, consult an attorney.
• Trademark – You’ve probably spent a lot of time thinking about your name, marketing slogans, product titles, and the like. Trademark everything that you don’t want to lose to another company.
• Patent – As far as the courts are concerned, what you don’t patent doesn’t belong to you; therefore, pay close attention to patent law and file on behalf of any invention unique to your business . This can be an extremely important investment, as it can prevent even the largest of companies from using your intellectual property (without paying you, of course), and it builds credibility for you and your business.
• Fair dealing refers to a limitation and exception to the exclusive right granted by copyright law to the author of a creative work. It is found in many of the common law jurisdictions of the Commonwealth of Nations. In United Kingdom law is a doctrine which provides an exception to United Kingdom copyright law, in cases where the copyright infringement is for the purposes of non-commercial research or study, criticism or review, or for the reporting of current events.
• Plagiarism refers to the practice of taking someone else’s work or ideas and passing them off as one’s own. Or turning in someone else’s work as your own. Or copying words or ideas from someone else without giving credit. Or failing to put a quotation in quotation marks. Or giving incorrect information about the source of a quotation. Or changing words but copying the sentence structure of a source without giving credit. Or copying so many words or ideas from a source that it makes up the majority of your work, whether you give credit or not. Many people think of plagiarism as copying another’s work or borrowing someone else’s original ideas. But terms like “copying” and “borrowing” can disguise the seriousness of the offense.

  Weakness of Kenya copyright law

The Weakness of Kenya copyright laws are: Duration of copyright, limited suite of rights, Subject matter.

• Duration of copyright

Copyright has a limited duration, after which copyright material enters the public domain and may be free used by anyone for any purpose.

• Limited suite of rights

A copyright owner’s capacity to control the use of his or her work is limited to the suite of rights, which is specifically granted by the copyright regime. This right typically includes the right to reproduce, the right to communicate to the public, the right to publish etc. uses that fall outside this rights are not subject to the copyright owner’s control. For example, copyright permission is required to print copies of a book,’ however, once a legitimately-printed copy as been sold, the copyright owner may not control what is done with that copy (with the expansion of importation in some jurisdiction and rental and lending rights in Europe). The purchaser is free to read the book multiple times, lent, borrow, sale or destroy it. (This was enshrined in USA law as the ‘doctrine of first sale’.

• Subject matter.

Copyright historically applied only to books. It has been expanded ever since to include ever-widening set of creative and non-creative material. For example, some compilations of purely factual data (e.g. Directories)may be protected by copyright, if they fulfill the originality test, as well as by a unique database protection in many jurisdictions, although notably, not in the U.S  In those jurisdictions where such data is protected ,the traditional distinction between an idea and its expression in copyright is broken down and means that users are constraint from extracting factual data contained in  a date base(such as residential address)as well as more creative environment, other exceptions and limitation have become more important than ever. It should not be forgotten that copyright is a monopoly right. Without exceptions, copyright owners would have a complete monopoly over learning, and thus control access knowledge in the digital age.

Challenges faced by libraries in implementing copyright law

• Maintaining the framework of exclusive rights.
• Technological adjuncts to copyright protection.
• Markets and management of rights.
• Reducing inefficiencies for subsequent users.

Information Privacy Law

Information privacy law or data protection laws prohibit the disclosure or misuse of information about private individuals.

Legal Deposit Law

Legal deposit is a statutory obligation on publishers and distributors to deposit at least one copy of every publication free of charge in designated legal deposit libraries.

Legal Deposit

is a requirement under the Copyright Act 1968 for publishers and self-publishing authors to deposit a copy of any print work published in a country with the National Library.

What is covered by legal deposit?

Books, serials such as newsletters or annual reports, newspapers, sheet music, maps, posters, plans, charts, tables, programmes, catalogues, brochures or pamphlets.

Advantages of  a well prepared and enforced Legal deposit Law in a Country

• The nation’s published output is collected systematically and become part of the national heritage.
• Publications are recorded in the online catalogues of legal deposit libraries and become an essential research resource.
• Deposited publications are made available to users of the deposit libraries on their premises.
• Published material is preserved for the use of future generation.
• Legal Deposit ensures that publications are preserved for use now and in the future.
• Promote interlibrary lending both locally and internatially.this can improve information flow between libraries in different countries.
• Enhance accessibility to information
• Act as public relations tool

  Revision Exercise

• Identify three challenges that may be faced by Libraries in Implementing the Copyright Law.
• Explain the importance of a National Information Policy in a country.
• State three weaknesses of Kenya copyright law.
• List three functions of Kenya National Library Service act.
• Highlight six challenges that are likely to be encountered in enforcing privacy law in Kenya.
• Explain four advantages of legal deposit law in a country.
• List four National Information legislations in Kenya.
• Outline two international Conventions relating to information.
• Explain four reasons that make most information Legislations in Kenya difficult to enforce.
• Highlight six weaknesses of Kenya Library Association (KLA) in upholding member’s professional skills.
• Highlight the functions of a professional association.
• As a librarian how do you exercise your freedom of expression?
• What is freedom of expression?

Refers to the suppression of speech,public, communication or other Information on the basis that such material is considered objection.

Explain circumstance that led to censorship

• For moral censorship –there are some facts that may be inappropriate for the audience such as pornography. This should not be disclosing to children since it will ruin their behavior.
• Military censorship- all the information may be censored since it guarantees that the enemy cannot get information that might be used plan an attack.
• Political censorship- a government may hold back certain kind of information and censored
• Religious censorship-there dominant religion which removes or change kind of information
• Corporate censorship-some business stop publication of materials because it shows some of their business idea or their employees in bad light is not good.

how censorship in libraries and information center are carried out

• Through users discovers material in the library that they find objectionable
• The user alerts library staff about the materials and often assumes are not aware of the material and will agree with them to remove it.
• Material are seldom removed through this process because material have already met selection process policy standards. Materials are usually remove for political purpose.
• Through seek in more official routes by patron; filling out a challenge form.
• Through contacting the local media organizing an ado protesting group, staging a peaceful protest and outright theft or destruction of the materials from the library circulation.
• They also consider complain and review material in question.
• Through comparing of materials to material selection policy that is guidelines by which libraries chose materials for selection.

importance of having legal procedures in information centers.  Legal procedures re the method by which legal rights are enforced.

• It helps in elimination of common misunderstanding by the identifying job responsibilities. This will have allowed managers to control events in advance and prevent the organization from making costly mistakes.
• Procedure has a substance – in the practice of regard for procedure it has substance in all aspects both in life and an organization.
• It gives clearly sequence of steps to be followed in a consistent manner. This is done the creating and define right that exist under the law.

Information policy

is the set of all public laws, regulations and policies that encourage, discourage, or regulate the creation, use, storage, access, and communication and  dissemination  of information

information policy refers to the laws and policies that deal with the stages information goes through beginning with its creation, through its collection, organization, dissemination, and finally to its destruction

There are several fundamental issues that comprise information policy.

• Public policy – issues concerned with the use of information for democratization and commercialization of social life. These issues include, inter alia, digital environment, such as
• intellectual property , economic regulations, freedom of expression, confidentiality or privacy of information,
• information security , access management, and regulating how the dissemination of public information occurs.

Types and importance

The types of information policy can be separated into two different categories. It can be discussed in :

• short-term focus exclusively on information science. It can also have a much broader context in relation to different subjects and be within a larger time period, for example

reason for the need of information policy

• deals with the legal issues that can be associated with the advancement of technology.
• More precisely, — the digitization of the cultural content made the cost of the copy decreasing to nearly zero and increased the illegal exchange of files, online, via sharing web site or off line (copy of hard disks). As a result, there are many grey areas between what users can and cannot do, and this creates the need for some sort of regulation.
• mark the boundaries needed to evaluate certain issues dealing with the creation, processing, exchange, access, and use of information

Information policy includes:

Types of information policies

• Public policy issue:

a fundamental enduring conflict among and between objectives, goals, customs, plans, activities and stakeholders, not likely to be resolved completely in favor of any polar position in that conflict, but changes in environment may require striking a fresh balance among conflicting forces from time to time.

• ICT Policy:

Information and Communications Technologies (ICT) environment is dynamic and rapid technological development is changing how we communicate and access information and services. Separate frameworks have guided the development of the Telecommunications & Postal Services sector since 1994.

• Circulars policy:

A government circular is a written statement of government policy. It will often provide information, guidance, rules, and/or background information on legislative or procedural matters.

• 5.It enhances the privatization and distribution of government/ county’s information.
• For avoiding risks (financial losses from incomplete and uncoordinated exploitation of information, wasted time, failures of innovation, and reputation loss);
• For positive benefits, including negotiation and openness among those responsible for different aspects of information management
• Productive use of IT in supporting staff in their use of information
• Ability to initiate change to take advantage of changing environments

Types of  information policies /National information Legislation in Kenya

There are some issues around organizational information polices, [5] which are the interaction between human beings and technology for using information,

• the issue to proceed information policy itself, whether to-down or middle-up-down, is the best way to approach information policy in an organization. Also,
• issues that information is tend to be influenced by organization’s culture that resulted in complexity of information flow. Moreover,
• the concern about valuing information is discussed by Orna, the fact that value of information is depend on the user, and it can’t be measured by price. Considering that information is as assets or intellectual capital that become valuable when it is put in the productive ways.

Government role

Like with any policy, there needs to be an agent to govern and regulate it. With information policy in a broader sense, the government has several roles and responsibilities. Some examples include

• providing accurate information, producing and maintaining information that meets the specific needs of the public,
• protecting the privacy and confidentiality of personal and sensitive information, and making informed decisions on which information should be disseminated and how to distribute it effectively, among others
• , the analysis of information policy should not only include the formal decision making processes by government entities, but also the formal and informal decisions of both the private and public sector of governance

Security vs freedom of information

A persistent debate concerning the government role in information policy is the separation of security and freedom of information. Legislation such as the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism (USAPATRIOT or USAPA) Act of 2001 is an example of security taking precedence over civil liberties. The USAPA affected several surveillance and privacy laws to include: [15]

• Wire Tapping (Title III) which requires there be probable cause for real-time interception of voice and data communication. [15]
• Electronic Communications Privacy Act(ECPA) regulates government access to email and other electronic communications. [15]
• Foreign Intelligence Surveillance Act (FISA) authorizes the government to carry out electronic surveillance against any person, including Americans. [15]

real situation and study its outcome.

The future – where information policy is headed

In regards to the future of information policy, it should be

• flexible and changing to different circumstances as the ability to access, store, and share information grows.
• information policy might include setting a boundary to the uncertainty in this field. As information policy becomes a larger and more important topic,
• it will also become a greater subject to governmental regulation in regards to the future of technology as well.
• It will also include the studies of these subjects: information science, communications, library science, and technology studies. [2]

The information policies will earn more advantages for national and organizational,

• influence people for paying attention to the socio aspect and socio-technical system, for securing preservation of digital content, bringing out information product,
• also respecting all users and making thinking time respectable.
• A single nation can take the lead in establishing communication-based relationships specifically regarding the internet. These relations will need to be slowly and consistently established in order to truly unify any kind of information policy and decision-making.
• If information policy can be established and guided on a semi-national level, the degree of communication and cooperation throughout the world will increase dramatically.
• As information policy continues to shape many aspects of society, these international relations will become vital (Harpham, 2011).
• Information policy is playing a greater role in the economy leading to the production of goods and services, as well as selling them directly to consumers (UCLA, 2009).
• The cost of information varies from a tangible good in that initial costs of the first unit are large and fixed; however, after that, marginal costs are relatively low (MacInnes, 2011).
• As an increase from the information services, information can be paralleled to that of manufacturing several years ago (UCLA, 2009). The digitalization of information allows businesses to make better justified business decisions (MacInnes, 2011).

the importance of legal systems and legal procedures in an Information center

• The legal system gives every person a venue to file a complaint.
• Resolve disputes among those who can’t agree by themselves.
• They work as scholars to evolve the law as society evolve.

TOPIC 6-proffessional ethics in information management

CODE OF ETHICS

Code of Ethics refers to a statement of policies, rules or principles that guide behavior of information centre professionals.

It’s also referred to a set of guidelines which are set or designed for a particular group, association or profession. Codes of ethics certainly do not apply only on information center but they should guard the behaviors of all the persons in an information center and in everyday life. It increases confidence in an information center by showing outsiders those members of ethics guidelines in the cause of doing your work. They lay down standards of inherit professionalism and confidentiality which all members of the association shall be bound to respect they include:

• Open access
• Privacy access  to information
• Intellectual information

Purpose of code of ethics

• It reinforces the moral principles and commitments of an information centre by spelling out acceptable and responsible behavior in a way that is clear to all within the organization.
• It tells others what the information centre stands for and what to expect when providing their services
• it improve the quality and consistency
• 4.it raise awareness and consciousness of issues
• it improve the profile of profusion

Importance of professional code of ethics

• Access to information
• Privacy and security
• Responsibility towards and individual and society
• Nature personel intergrity and professional skills
• Open access to interlectual property

Components of Ethics

There are two parts of code of ethics namely:

• It outline the information centre aspiration
• It explains the information center’s values and translates them into standards and Procedures to be followed by the staff

Element /component of professionalism

• Consistency

Factors to considered in developing code of ethics for librarian and information professional

• Content of code
• Implementation of the code
• Language use for communication

Ethical standards for various information professionals

• Librarian should not discriminate or be against library users
• Should respect confidentiality of every library users
• Should honor the freedom of library in collecting and preserving library materials
• Librarian should make it a professional aim to familiarize himself with materials of recording knowledge and experiences
• Should actively participate in formation of policies in the operation and service of library
• Should cooperate with other librarians in the effort to develop good confidential evidence.

Issues to be address in the code of ethics for librarian and others information personnel

• The rationel of the code-this is the justification of the code .it explain why code has been develop and the purpose .it is meant to serve for organization
• Ethical values of standards-this is provide the norms that guide the proffesion all beheviours,they set ethical target for all and can be considered backbone of any ethical code.
• Performance standards-issues dealing with performance standards when dealing with client should be considered
• Cultural aspect
• Issues of interectual freedom
• Gender issues
• Professional development.

Organizational Structure refers to the administrative layout of an information centre, a pattern of relationship among members and positions in an information centre. Or it refers to the prescribed patterns of work-related behavior which are deliberately established for the accomplishment of the information centre’s objectives.

Role of an Organizational structure

• It divides work among members of the organization as well as coordinating activities so that they are directed towards achieving the goal and the objectives of the organization.
• It defines task responsibilities, work roles, relationship and communication channels
• It helps the staff members and interested outsiders to know how the library is organized
• It provides order/ clarifies relationship as well as showing the status of various positions
• It shows the flow of authority and responsibility

Chain of Command refers to the line of authority and responsibility along which orders are passed within an information center and between different sections. Orders are transmitted down the chain of command from higher ranked personnel such as a library manager to lower ranked personnel who either execute the order personally or transmit it down the chain as appropriate until it’s received by those expected to execute it.

Hierarchy refers to a group of people dedicated to carry out orders from the top that is of authority. It’s part of power structure. It makes clear who answers to who and where they fit in the chain of command

Efficiency is the ability to avoid wasting materials, energy, efforts, money, and time in doing something or in producing a desired result. In a more general sense, it is the ability to do things well, successfully, and without waste.

Decision making is regarded as the cognitive process resulting in the selection of a belief or a course of action among several alternative possibilities. The purpose of organizational structure is to show that a decision group can be seen as a task force built and assembled on top of organization.

Flexibility in serving clients: organizational structures occur when employees discover that one employee serves as a better leader than the others or when a group of employees comes together and inspires the development of new, creative ideas for accomplishing business tasks.

Types of organizational structure

Advantages of Functional Design/ Organizational Structure

• Efficient use of resources by grouping common task together resources can be well utilized in addition each department is able to serve other department efficiently.
• There is an independent skill development i.e. more intensive training of members is positive within departments.
• Provides clear career paths i.e. employee have a clear understanding of the job requirements and even the path that will lead to promotion.
• Enable strategic decision to be made at the top. A centralized decision structure facilities unity of direction.
• Enhances co-ordination within functions i.e. facilitates efficient communication process between members within a department and other outside the department.

Disadvantage of a functional design

• Show decision making because of different mangers coming up with various plan which has to be communicated to the other mangers for the fiscal decision to be made.
• Decision are made at the top
• Poor co-ordination access functional, unwillingness among members to support others can lead to poor co-ordination
• Performance responsibility is unclear, the failure and success of the organization are outcomes of all activates within the organization. The contributions of each department can’t be clearly known.
• Members can be less innovative because the member becomes focused only on the departmental rather than overall goal.
• Limited management training with limited training management mangers will be well equipped to solve problems in large organization

Revision Exercise 4

• Explain the types of organizational structures observed in most business organisation
• State the unethical practices that may be found among staff in an information centre
• Identify the indicators of low morale amongst staff in an information centre.
• State the ethical values required by an archivist to offer effective services
• Define the term “ code of Ethics” as it applies to information science professionals
• List the purposes of code of ethics for information professionals
• Outline the unethical behavior that may practice by some library staff
• Highlight the Challenges that are likely to be encountered by libraries operating without code of ethics
• Explain the role of code of ethics for information providers
• List the information science related professions that have different codes of ethics
• Highlight the challenges that have been encountered by Kenya information professionals in developing a code of ethics.
• Explain the ways of team building at workplace
• Explain the advantages of code of ethics.
• Highlight the levels of management that may be found in a library
• Discuss the impact span of management has on an organization’s structure.
• Discuss the meaning of organization design and show the major contingencies that affect design.
• Give an illustration of an organization structure for any of the following information centers

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Members of classic rock band in legal dispute over alleged financial issues: Report

• Published: Aug. 04, 2024, 8:00 p.m.

This April 7, 2017 file photo shows members of Journey, Steve Smith, from left, Ross Valory, Aynsley Dunbar, Gregg Rolie, Neal Schon and Jonathan Cain at the 2017 Rock and Roll Hall of Fame induction ceremony in New York. Andy Kropa/Invision/AP

• Scott R. Axelrod | [email protected]

Members of iconic rock band Journey are currently in the middle of a legal situation as keyboardist/guitarist Jonathan Cain has filed suit against founding band member Neal Schon, claiming the guitarist has been irresponsible with the band’s finances, Bloomberg is reporting

According to the outlet, Cain alleges that Schon maxed out the band’s American Express card which has a $1 million limit, and that he overspent on their $1,500 hotel allowance, hired private jets, hired a friend as security and has generally made it difficult for the band to cover their debts.

The suit, which was filed on July 30, states that the situation “is a very much public battle between petitioner and respondent and is impacting the band’s reputation throughout the music industry. The band’s actual onstage performance is, at the moment one of the only aspects of the business that has not suffered,” the report said.

This is not the first time the two bandmates have battled in court, as Schon filed a cease-and-desist against Cain in 2022 for the latter having performed the band’s hit “Don’t Stop Believin’” at a Mar-a-Lago event hosted by former President Donald Trump, the report said.

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Liberty University acquires Virginia Technical Institute, expands trade training   

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August 1, 2024 : By Office of Communications & Public Engagement

Liberty University has announced the acquisition of the educational components of Virginia Technical Institute (VTI) in Altavista, Va.

VTI and Liberty have collaborated for more than a decade. Through Liberty’s Technical Studies Program , students take courses at VTI in welding, plumbing, electrical, carpentry, HVAC, and more while simultaneously earning their degree. Students use the courses for credit as electives or minors as they gain various credentials and licenses that can lead to more career options after graduation.

With the acquisition, Liberty will use VTI’s programming and resources to enhance its current for-credit course offerings and expand them into the not-for-credit environment through the Center for Professional and Continuing Education . Students — especially adult students, military veterans, and employees looking to learn a skill or trade — will gain the skills necessary to quickly enter the workforce rather than spend several years earning a degree.

“I believe this new acquisition reinforces our commitment to expanding skilled trade training,” said Liberty Provost and Chief Academic Officer Scott Hicks. “This strategic move will further the university’s mission to Train Champions for Christ by preparing students, the community, and beyond for successful careers in critical trades and further strengthening the future of our workforce.”

Liberty will build upon the trade school’s reputation as a quality deliverer of hands-on, technical and trades-based education.

“This alliance is another step on the highway of success for the technically gifted,” said VTI founder Dale Moore. “The shared vision between VTI and Liberty University will enhance trade training, fostering an environment where talent meets opportunity. Together, we are building dreams, creating hope for the future, and celebrating what God continues to do.”

VTI’s training curriculum is approved by the National Center for Construction Education and Research (NCCER).

For more information on course offerings and the Associate of Applied Science (A.A.S.)  in Technical Studies, visit the Technical Studies website .

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Georgia superintendent says Black studies course breaks law against divisive racial teachings

FILE - Georgia Superintendent of Schools Richard Woods speaks to reporters, Jan. 5, 2024, in Atlanta. Woods, an elected Republican, is refusing to approve an Advanced Placement course in African American Studies. That led Gwinnett County, the state’s largest school district, to announce Tuesday, July 30, that it wouldn’t teach the course. (AP Photo/Jeff Amy, File)

Georgia state Sen. Nikki Merritt, D–Grayson, delivers remarks at a joint Senate and House press conference on the State School Superintendent’s decision to block an AP African American Studies course at the Georgia State Capitol, Wednesday, July 24, 2024, in Atlanta. (Matthew Pearson/WABE via AP)

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ATLANTA (AP) — Georgia’s state superintendent of schools said Wednesday that he believes a new Advanced Placement course in African American Studies violates the state’s law against teaching divisive racial concepts, explaining that is why he won’t recommend it become an approved state course.

Until now, Richard Woods, the state’s elected Republican superintendent, hadn’t explained why he was blocking approval of the course. Some districts have said they will teach it anyway, but others have canceled their plans.

“After reviewing the content, it was clear that parts of the coursework did violate the law,” Woods said after 10 days of only expressing vague concerns.

Georgia’s 2022 ban on teaching divisive racial concepts in schools, based on a now-repealed executive order from President Donald Trump, prohibits claims that the U.S. is “fundamentally or systematically racist.” It mandates that no student “should feel discomfort, guilt, anguish, or any other form of psychological distress because of his or her race.” So far, 18 states have passed such bans.

The Advanced Placement course drew national scrutiny in 2023 when Florida’s Republican Gov. Ron DeSantis said he would ban the course in his state . In June, South Carolina officials also refused to approve the course. South Carolina said individual districts could still offer it.

The College Board is a nonprofit testing entity that offers Advanced Placement courses across the academic spectrum. Students who score well on an exam can usually earn college credit. Spokesperson Holly Stepp said the African American Studies class is “a dynamic and robust course that is rooted in academic scholarship,” and denied that it seeks to indoctrinate students.

“AP students are expected to analyze different perspectives from their own, and no points on an AP Exam are awarded for agreement with a viewpoint,” Stepp said.

Woods’ claim contradicts a specific exemption in Georgia law for Advanced Placement and other high-level college courses. State Rep. Will Wade, a Dawsonville Republican and former school board member who wrote the law, pointed to the carve-out allowing such concepts to be taught in AP courses in a text message.

More confoundingly, Woods has been saying that districts could teach the AP material and get state money by listing it as an introductory African American studies course approved by the state in 2020. Woods took that position after earlier saying districts would have to teach the course using only local tax money .

But Wednesday, Woods said teaching the AP material using the introductory course could expose a district to legal challenges under Georgia’s law. Thus, Woods may be imperiling districts legally by denying the AP course, while he could protect them legally by approving it.

“It makes no sense,” said state Sen Nikki Merritt, a Democrat from Grayson and critic of Woods.

The superintendent said he was seeking a legal opinion from Attorney General Chris Carr as to whether the carve-out would protect AP courses. “Should the ruling reverse my decision, then I will follow the law,” Woods said in his statement. But Meghan Frick, a spokesperson for Woods, said that doesn’t mean Woods will recommend the course for approval by the state Board of Education if Carr’s office backs it legally.

Woods has faced not only attacks from Democrats, but pointed questions from Republican Gov. Brian Kemp. A spokesperson for Kemp declined comment Wednesday when asked whether the governor believes the course violates state law.

Under the law, if people allege a violation and it isn’t resolved locally, they can appeal to the state Board of Education. The board could order a corrective action plan, and a district could lose exemptions from state rules if it didn’t comply. Districts rely on those exemptions to set policy locally.

Since the law has taken effect, Frick said there haven’t been any appeals to the state board.

Woods, who is white, said he was particularly concerned about how the course presents the concept of intersectionality. That’s a framework for understanding the effects of overlapping systems of discrimination or disadvantage. For example, Black women may face compounding disadvantages because of their race and gender.

“If the Advanced Placement course had presented a comparative narrative with opposing views on this and other topics, an argument could be made that the course did not violate Georgia law,” Woods said in a statement.

Stepp said intersectionality is one of 74 required topics in the course.

Mikayla Arciaga, who leads Georgia advocacy efforts for the Intercultural Development Research Association, called for the repeal of the divisive concepts law. “Being Black in America should not be a divisive concept,” she said in a statement.

The Atlanta, DeKalb County and Cobb County school districts have all said they will offer the course in some high schools.

The state’s largest district, Gwinnett County, said Tuesday that it wouldn’t offer the course. That is because students wouldn’t get the credit that an approved AP course brings in deciding whether a student qualifies for the HOPE Scholarship merit program.