Health Law Research Paper Topics

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This page offers a comprehensive guide on health law research paper topics aimed at students studying law and assigned to write research papers. The page is structured into several sections to provide a complete resource for students, starting with an abstract that introduces the keyphrase and sets the context for the content. It will cover a comprehensive list of health law research paper topics divided into 10 categories, an in-depth article on health law and its wide range of research paper topics, tips on choosing suitable topics, and guidance on how to write an effective health law research paper. Additionally, the page will present iResearchNet’s custom health law research paper writing services.

100 Health Law Research Paper Topics

Health law is a multifaceted field that intersects with various aspects of healthcare, ethics, policy, and regulations. As students venture into the world of health law research, they encounter a vast array of intriguing topics that hold immense relevance in today’s healthcare landscape. This section presents a comprehensive list of health law research paper topics, carefully curated into ten distinct categories, each offering unique perspectives and opportunities for in-depth exploration. Whether you are interested in analyzing the legal implications of healthcare policies, delving into medical ethics dilemmas, or examining the legal aspects of global health, this diverse collection of health law research paper topics aims to inspire students to embark on meaningful and impactful research endeavors in the realm of health law.

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  • The Impact of the Affordable Care Act on Healthcare Access and Affordability
  • Medicaid Expansion and its Effect on Low-Income Populations
  • Healthcare Reform and the Future of Private Insurance Companies
  • Assessing the Legal Framework of Universal Healthcare Systems
  • Analyzing the Role of Health Insurance Marketplaces in Improving Coverage
  • The Legal Landscape of Value-Based Care and Alternative Payment Models
  • Health Information Privacy and the Health Insurance Portability and Accountability Act (HIPAA)
  • Legal Implications of Medicare and Medicaid Fraud and Abuse
  • Medical Malpractice Laws and their Impact on Healthcare Providers
  • Telemedicine Laws and the Expansion of Virtual Healthcare Services
  • End-of-Life Decision-Making: Euthanasia and Physician-Assisted Suicide
  • Organ Transplantation: Ethical Allocation of Donor Organs
  • Informed Consent: Balancing Patient Autonomy and Medical Paternalism
  • Legal and Ethical Implications of Human Genome Editing
  • Confidentiality in Mental Health Treatment: Patient Privacy vs. Public Safety
  • The Role of Law in Addressing Human Reproductive Cloning
  • Legal and Ethical Considerations in Genetic Testing and Counseling
  • Ethical Challenges in Human Subject Research and Clinical Trials
  • Discrimination in Healthcare: Legal Protections for Vulnerable Populations
  • Legal and Ethical Dimensions of Artificial Intelligence in Medical Decision-Making
  • The Role of Law in Addressing Public Health Emergencies: Lessons from COVID-19
  • Legal Interventions to Promote Vaccination and Herd Immunity
  • Environmental Justice: Assessing the Legal Framework for Protecting Vulnerable Communities
  • Food Safety Regulation and the Prevention of Foodborne Illnesses
  • Tobacco Control Policies and their Impact on Public Health
  • Legal Aspects of Water Pollution Control and Environmental Regulation
  • Legal and Ethical Considerations in Controlling Infectious Diseases Outbreaks
  • Health Impact Assessments: Evaluating the Legal Framework for Community Health
  • The Intersection of Environmental Law and Occupational Health and Safety
  • Climate Change and Health: Legal Strategies for Mitigation and Adaptation
  • Involuntary Commitment: Balancing Individual Liberty and Public Safety
  • Legal and Ethical Challenges in Treating Minors with Mental Health Conditions
  • Mental Health Parity Laws: Improving Access to Mental Health Services
  • Legal Implications of Telepsychiatry and Online Mental Health Services
  • Mental Health Stigma and Discrimination: Legal Measures for Social Change
  • Legal Considerations in Mental Health Treatment for Individuals with Intellectual Disabilities
  • Criminalization of Mental Illness: Examining Mental Health Courts and Diversion Programs
  • Legal and Ethical Issues in the Confidentiality of Mental Health Records
  • The Role of Law in Addressing the Opioid Epidemic: Prevention, Treatment, and Harm Reduction
  • Legal Protections for Patients with Substance Use Disorders: Advocating for Their Rights
  • Detecting and Preventing Healthcare Billing Fraud and Abuse
  • Whistleblower Protections: Encouraging Reporting of Healthcare Fraud
  • Legal and Ethical Issues in Off-Label Drug Marketing
  • The Role of Data Analytics in Fraud Detection and Prevention
  • False Claims Act Cases: Evaluating their Impact on Healthcare Providers
  • Kickbacks and Stark Law Violations: Legal Implications for Healthcare Entities
  • Anti-Kickback Statute and Safe Harbors: Analyzing their Effectiveness in Preventing Fraud
  • Legal Challenges in Investigating and Prosecuting Healthcare Fraud
  • Healthcare Compliance Programs: Legal and Ethical Considerations
  • Restitution and Remedies for Healthcare Fraud: Balancing Justice and Rehabilitation
  • Medical Malpractice Laws and their Impact on Patient Safety
  • Medication Errors: Legal Implications and Preventive Measures
  • Legal Aspects of Adverse Events and Medical Negligence
  • Liability for Healthcare Technology and Telemedicine Services
  • The Influence of Tort Reform on Patient Safety and Healthcare Practices
  • Legal Protections for Patient Safety Advocates and Whistleblowers
  • Legal and Ethical Considerations in Error Disclosure and Apology
  • The Role of Law in Reducing Healthcare-Associated Infections
  • Healthcare Error Reporting Systems: Evaluating their Efficacy in Improving Safety
  • The Legal Landscape of Patient Safety Culture in Healthcare Organizations
  • Ethical Implications of Human Gene Editing and Genetic Engineering
  • Cloning and Stem Cell Research: Legal and Ethical Boundaries
  • The Ethics of Human Research and Clinical Trials in Biotechnology
  • Legal and Ethical Issues in Human Reproduction Technologies
  • The Role of Law in Regulating Gene Therapy and Genetic Enhancements
  • Legal Considerations in Bioinformatics and Genomic Data Sharing
  • The Intersection of Bioethics and Artificial Intelligence in Healthcare
  • Ethical Challenges in Neurotechnology and Brain-Computer Interfaces
  • Legal and Ethical Implications of Organ Transplant Allocation
  • Gene Patents and Intellectual Property Rights: Balancing Innovation and Access
  • Legal Strategies for Addressing Healthcare Disparities and Inequalities
  • The Role of Law in Ensuring Access to Affordable Prescription Drugs
  • Health Equity and Social Determinants of Health: Legal Approaches for Change
  • Medicaid Expansion and Health Insurance Coverage for Vulnerable Populations
  • Legal Protections for Immigrant Healthcare Access
  • Healthcare Rationing and Resource Allocation: Ethical and Legal Challenges
  • The Impact of Discrimination on Health Outcomes: Legal and Policy Responses
  • Legal and Ethical Considerations in Reproductive Healthcare Access
  • The Role of Law in Promoting Mental Health Equity
  • Legal and Policy Approaches to Reduce Health Disparities in Rural Areas
  • Data Privacy and Security in Digital Health Records
  • Telehealth Policy and Regulation: Promoting Access and Quality
  • Legal Challenges in AI-Based Medical Diagnostics and Decision Support Systems
  • Legal and Ethical Implications of Health Data Analytics and Machine Learning
  • Cybersecurity in Healthcare: Mitigating Risks and Ensuring Compliance
  • Legal Considerations in Internet of Things (IoT) Medical Devices
  • Regulation of Health Apps and Wearable Health Technology
  • Legal and Ethical Aspects of Health Information Exchange
  • The Role of Law in Regulating Precision Medicine and Personalized Healthcare
  • AI in Clinical Decision-Making: Liability and Accountability Issues
  • International Health Regulations: Legal Framework for Pandemic Preparedness
  • The Role of Law in Addressing Global Health Crises and Disease Outbreaks
  • Legal Aspects of Humanitarian Medical Aid and Disaster Relief
  • Intellectual Property Rights and Access to Medicines in Developing Countries
  • Legal and Ethical Considerations in Medical Tourism
  • Legal Implications of Cross-Border Healthcare and Telemedicine
  • The Role of Law in Protecting the Rights of Refugees and Displaced Populations
  • Global Health Governance and the Role of International Organizations
  • Legal and Ethical Challenges in Global Vaccine Distribution
  • Environmental Health and International Agreements: Navigating Legal Boundaries

The realm of health law is a dynamic and evolving field with far-reaching implications for society’s well-being and the healthcare landscape. The comprehensive list of health law research paper topics presented in this section demonstrates the diverse and complex nature of this legal discipline. From examining the intricacies of healthcare policies and regulations to exploring medical ethics dilemmas and global health challenges, students have an extensive range of subjects to delve into for their research projects. As aspiring legal scholars and practitioners, delving into these topics will not only expand their knowledge but also contribute to the ongoing advancements and improvements in healthcare delivery, ethics, and policy. Through in-depth research and analysis, students can actively contribute to shaping a more just and equitable healthcare system for generations to come.

Health Law: Exploring the Range of Topics

Health law is a crucial and multifaceted field that intersects with various aspects of healthcare, ethics, policies, and patient rights. As the legal landscape continues to adapt to the complexities of modern healthcare systems, the study of health law becomes increasingly significant. This section delves into the world of health law, highlighting its relevance and the diverse range of research paper topics it offers.

  • Understanding Health Law and Its Significance : Health law encompasses a broad spectrum of legal principles and regulations that govern the healthcare industry and the rights of patients. Its primary goal is to ensure the provision of high-quality healthcare while safeguarding patients’ rights and ethical standards. Health law is an indispensable component of the legal system, as it addresses the legal implications of medical practices, healthcare policies, and medical research.
  • Ethical Considerations in Health Law Research : Medical ethics plays a central role in health law research, as it deals with the moral and ethical dilemmas faced by healthcare providers, patients, and policymakers. Topics in this area may include the ethical implications of medical experimentation, end-of-life decision-making, informed consent, and confidentiality of patient information.
  • Healthcare Policies and Regulations : Health law heavily influences healthcare policies and regulations, which shape the delivery and accessibility of medical services. Research topics in this category could explore the Affordable Care Act and its impact on healthcare access, the regulation of health insurance providers, healthcare reform initiatives, and the role of government in healthcare policy-making.
  • Patient Rights and Advocacy : Health law upholds and protects the rights of patients, ensuring they receive fair treatment and access to appropriate medical care. Research papers in this area may cover patient privacy rights, informed consent, the right to refuse medical treatment, and the legal avenues available for patients seeking redress for medical malpractice.
  • Medical Malpractice and Liability : The study of health law involves an examination of medical malpractice laws and the legal implications of medical errors. Research topics may include the standard of care in medical practice, the role of expert witnesses in medical malpractice cases, and the impact of medical liability insurance on healthcare costs.
  • Healthcare Fraud and Abuse : Health law addresses issues related to healthcare fraud and abuse, aiming to prevent fraudulent activities in the healthcare industry. Topics in this category could explore Medicare and Medicaid fraud, kickbacks in healthcare, and the legal measures taken to combat healthcare fraud.
  • Health Equity and Access to Care : Health law plays a critical role in promoting health equity and ensuring equitable access to healthcare services for all individuals. Research topics may delve into the legal challenges in achieving health equity, disparities in healthcare access, and the legal framework for addressing healthcare inequalities.
  • Mental Health Law and Policy : The intersection of law and mental health is a significant area of research in health law. Topics in this field may cover the legal rights of individuals with mental health conditions, involuntary commitment laws, and the integration of mental health services into the broader healthcare system.
  • Public Health Law and Emergency Preparedness : Public health law is concerned with safeguarding the health and well-being of the community. Research topics may include the legal framework for responding to public health emergencies, vaccination policies, and legal challenges in disease outbreak management.
  • Biomedical Research and Human Subjects : Health law addresses the ethical and legal considerations in biomedical research involving human subjects. Topics in this area may explore informed consent in research, the protection of vulnerable populations, and the legal framework for clinical trials.

The complexities and evolving nature of health law present a myriad of research opportunities for students and scholars. As healthcare continues to advance, so do the legal and ethical challenges it brings. By exploring the diverse range of health law research paper topics, students can actively contribute to shaping the future of healthcare and the legal framework that governs it. Through in-depth research and analysis, they can propose innovative solutions to address the ethical, policy, and legal complexities of modern healthcare systems. As the field of health law continues to evolve, the research carried out by students will undoubtedly have a profound impact on shaping a more just, ethical, and equitable healthcare system for society as a whole.

How to Choose a Health Law Topic

Selecting a compelling and relevant research paper topic is a crucial step in the academic journey of law students exploring health law. With the vast array of legal issues and ethical considerations within the healthcare domain, narrowing down a specific research focus can be challenging. However, with a systematic approach and a clear understanding of your interests and objectives, you can navigate the process effectively. This section presents essential tips to help you choose the most suitable health law research paper topic for your study.

  • Understand Your Course and Assignment Requirements : Before diving into the topic selection process, thoroughly review your course syllabus and assignment guidelines. Ensure that you grasp the specific requirements set by your instructor and the objectives of the research paper. Understanding the scope, length, and format expectations will help you tailor your research to meet the necessary criteria.
  • Identify Your Areas of Interest : Health law is a vast and diverse field, covering various legal and ethical aspects of healthcare. Take some time to reflect on your personal interests and the areas of health law that intrigue you the most. Whether you are passionate about patient rights, healthcare policies, medical ethics, or public health, choosing a topic that resonates with you will make the research process more enjoyable and rewarding.
  • Stay Updated with Current Health Law Developments : Health law is constantly evolving due to advancements in medical technology, changes in healthcare policies, and legal precedents. To choose a relevant and timely research topic, keep yourself informed about recent developments and emerging issues in health law. Read academic journals, legal publications, and reputable news sources to stay updated with the latest trends and debates in the field.
  • Conduct Preliminary Research : To gain a deeper understanding of potential research topics, conduct preliminary research on broad health law themes that interest you. This will help you identify specific subtopics and issues within those themes that you find compelling. Take note of any gaps in the existing literature or areas that need further exploration.
  • Consult Your Professors and Peers : Engaging in discussions with your professors and peers can provide valuable insights and suggestions for potential research paper topics. They may offer guidance on relevant issues, recommend scholarly resources, and provide feedback on your initial ideas.
  • Analyze the Legal and Ethical Relevance : Once you have a list of potential research paper topics, evaluate their legal and ethical relevance. Consider the impact of the topic on healthcare policies, patient rights, and medical practices. Ask yourself how your research can contribute to the existing body of knowledge and address real-world challenges in health law.
  • Narrow Down Your Focus : As you evaluate your potential research topics, it is essential to narrow down your focus to a specific and manageable research question. Avoid overly broad topics that may lack depth and clarity. Instead, aim for a well-defined research question that allows you to conduct an in-depth analysis within the scope of your research paper.
  • Consider the Feasibility of Data Collection : Some research topics may require access to specific data, legal documents, or expert interviews. Consider the feasibility of data collection for your chosen topic. Ensure that you can access the necessary resources and information to support your research.
  • Evaluate the Significance and Impact : Assess the significance and potential impact of your chosen research topic. Think about how your findings and recommendations can contribute to improvements in healthcare practices, policies, or legal frameworks. A research paper with practical implications and real-world applications can make a more significant contribution to the field of health law.
  • Seek Inspiration from Case Studies and Legal Precedents : Case studies and legal precedents are valuable resources for inspiration and identifying research gaps in health law. Analyzing landmark cases and recent court decisions can shed light on emerging legal issues and ethical dilemmas in the healthcare sector.

By following these ten tips, you can navigate the process of choosing a health law research paper topic with confidence and purpose. Remember to select a topic that aligns with your interests, adheres to assignment requirements, and offers significant contributions to the field of health law. A well-chosen research topic will not only showcase your knowledge and analytical skills but also demonstrate your commitment to addressing legal challenges in the healthcare domain.

How to Write a Health Law Research Paper

Writing a health law research paper can be a rewarding and intellectually stimulating endeavor. However, it also requires careful planning, thorough research, and effective organization to produce a high-quality paper. In this section, we will provide you with a step-by-step guide on how to write a compelling health law research paper that showcases your understanding of the subject matter and analytical skills.

  • Understand the Research Paper Requirements : Before delving into the writing process, review your course syllabus and assignment guidelines to understand the specific requirements for your health law research paper. Take note of the paper’s length, formatting style (APA, MLA, Chicago/Turabian, Harvard, etc.), and any specific research questions or topics provided by your instructor.
  • Conduct In-Depth Research : Effective research is the foundation of a successful health law research paper. Take the time to conduct comprehensive research on your chosen topic, exploring relevant legal statutes, court decisions, academic journals, and reputable sources. Utilize online databases, libraries, and academic search engines to access scholarly articles and primary legal sources.
  • Develop a Strong Thesis Statement : The thesis statement is the central argument or main point of your research paper. It should be clear, concise, and specific, outlining the focus and purpose of your paper. Your thesis statement will guide the rest of your writing and help maintain a cohesive and coherent structure.
  • Create an Outline : An outline serves as a roadmap for your health law research paper, helping you organize your ideas and arguments logically. Divide your paper into sections, such as introduction, literature review, methodology (if applicable), main body, analysis, and conclusion. Within each section, outline the key points and supporting evidence you will include.
  • Write an Engaging Introduction : The introduction is your opportunity to grab the reader’s attention and provide an overview of your research paper. Start with a hook or an interesting fact related to health law to pique the reader’s interest. Clearly state your thesis statement and outline the key points you will discuss in the paper.
  • Conduct a Thorough Literature Review : The literature review is a critical component of a health law research paper. It involves summarizing and analyzing existing research and scholarly work relevant to your topic. Identify gaps in the literature and discuss how your research paper will contribute to addressing these gaps.
  • Present Clear and Coherent Arguments : In the main body of your research paper, present your arguments and supporting evidence in a clear and coherent manner. Each paragraph should focus on a single idea and include relevant examples, case studies, or legal precedents to strengthen your points. Use transitional phrases to ensure a smooth flow between paragraphs.
  • Analyze Legal and Ethical Implications : Health law research often involves analyzing legal statutes and ethical considerations. Make sure to critically assess the implications of your research findings on healthcare policies, patient rights, and medical practices. Discuss the ethical dilemmas, if any, and propose potential solutions.
  • Utilize Proper Citations and References : Properly cite all the sources you have used in your research paper to avoid plagiarism and give credit to the original authors. Use the appropriate citation style specified in the assignment guidelines (APA, MLA, Chicago/Turabian, Harvard, etc.) and create a comprehensive list of references at the end of your paper.
  • Craft a Convincing Conclusion : In the conclusion, summarize the main points of your research paper and restate your thesis statement. Emphasize the significance of your findings and their potential impact on health law. Avoid introducing new information in the conclusion and instead leave the reader with a lasting impression of your research.
  • Revise and Edit Your Paper : After completing the first draft, take the time to revise and edit your health law research paper. Check for clarity, coherence, and consistency in your arguments. Eliminate any grammatical or spelling errors and ensure that your paper adheres to the required formatting style.
  • Seek Feedback : Before submitting your research paper, seek feedback from peers, professors, or academic advisors. Constructive feedback can help you identify areas for improvement and enhance the overall quality of your paper.

Writing a health law research paper requires dedication, critical thinking, and a thorough understanding of legal and ethical issues in healthcare. By following this step-by-step guide and staying organized throughout the process, you can produce a well-researched and persuasive paper that contributes meaningfully to the field of health law.

iResearchNet’s Custom Research Paper Writing Services

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  • Expert Degree-Holding Writers : When you choose iResearchNet, you gain access to a team of highly qualified writers with advanced degrees in law, specializing in health law. Our writers have extensive experience in conducting research, analyzing legal cases, and writing comprehensive research papers on a wide range of health law topics.
  • Custom Written Works : We believe in the uniqueness of every research paper. Our writers follow a custom writing approach, meaning that each paper is tailored to your specific requirements, ensuring originality and authenticity. You can rest assured that your health law research paper will be entirely free of plagiarism.
  • In-Depth Research : Our writers are well-versed in conducting thorough research to gather the most relevant and up-to-date information for your health law research paper. They have access to reputable academic databases, journals, and legal resources, enabling them to include credible sources in your paper.
  • Custom Formatting : Proper formatting is crucial for academic research papers. Our writers are proficient in various citation styles, including APA, MLA, Chicago/Turabian, and Harvard. They will ensure that your health law research paper adheres to the required formatting guidelines.
  • Top Quality : Quality is our utmost priority. We strive to deliver research papers that demonstrate comprehensive understanding, critical analysis, and well-supported arguments. Our team is dedicated to providing you with top-quality research papers that showcase your knowledge and research skills.
  • Customized Solutions : At iResearchNet, we recognize that each health law research paper topic is unique. Our writers are adept at tailoring their writing to meet your specific research objectives and address the nuances of your chosen topic.
  • Flexible Pricing : We understand that students often have budget constraints. Our pricing system is flexible and designed to accommodate your financial needs. We offer competitive rates for high-quality custom health law research papers.
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International health law: an emerging field of public international law

  • Open access
  • Published: 06 April 2016
  • Volume 55 , pages 299–328, ( 2015 )

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health law research paper

  • Brigit Toebes   ORCID: orcid.org/0000-0003-0503-2004 1  

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This article discusses the nature and scope of international health law as an emerging field of public international law. It is argued that the protection of health reflects a pressing social need that should now be spoken of in the vocabulary of international law. Furthermore, there is an urgent need for counterbalancing interests such as international trade, global commerce and the welfare interests of the protection of the health of both individuals and populations worldwide. As of now, international health law is not a well-developed field. The health-related standard-setting legal instruments are very fragmented as there is no overall international recognition of international health law as a distinct branch of international law. Enormous challenges lie ahead, especially in terms of strengthening the existing instruments and addressing the responsibilities of non-state actors in the health field.

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1 Introduction

Ongoing globalisation has implications not only for the world’s economies, but it also seriously impacts on the health of both populations and individuals worldwide. Footnote 1 It poses a number of important challenges to the health field, demanding both national and international responses. Footnote 2 Traditionally, such international responses have focused on limiting the spread of infectious diseases. While the recent Ebola crisis has demonstrated that infectious diseases continue to pose a serious threat to global health, there are new and different global health challenges that need to be met as well, including the global rise in non-communicable (chronic) diseases. Footnote 3 Public health research indicates that health inequalities within and between nations are increasing, Footnote 4 and many countries continue to struggle with the detrimental health effects of environmental degradation, climate change, urbanisation and internal conflicts. Footnote 5 International trade and the growing influence of multinational corporations have resulted in changes in disease patterns, some of which are lifestyle-related. Footnote 6 As a result of these developments, attention to global health should be directed not only at the spread of infectious diseases but also at, for example, global and domestic health inequalities, issues concerning access to healthcare and medicines, and the care for health in international and national emergencies and armed conflicts. Footnote 7

This contribution is aimed at analysing and discussing the scope of international health law as an emerging branch of public international law. Footnote 8 Contrary to, for example, international trade law, international environmental law and international humanitarian law, international health law is not a well-developed field. This article will advance the idea that health equity, fairness in health or the ‘capability to be healthy’ is a key value that forms a core component of the human dignity of individuals. Health equity, or health justice, is currently not sufficiently emphasised in public international law as compared to, for example, international trade and humanitarian law. This article asserts that health equity and the protection of health need to be placed more firmly on the international law agenda so as to be able to balance the interests of trade, economic growth and warfare against the protection of the health of individuals and groups.

International standard-setting instruments are, increasingly, successfully employed by international organisations, state authorities and civil society organisations to achieve fairness in health. For instance, the Framework Convention on Tobacco Control (FCTC) has played a key role in several domestic court cases. However, as mentioned, there is currently no overarching international recognition of international health law as a distinct field of public international law.

In an attempt to create clarity in the field, this article focuses on the rationale, the sources, the scope and the responsible actors for international health law (sections 2–5, respectively). When it comes to the sources of international health law, this article will address the most important standard-setting instruments under this branch of international law. These instruments vary from legally binding instruments (FCTC and International Health Regulations), to legally binding norms (right to health and other human rights norms), to authoritative yet non-binding instruments World Health Organisation (the WHO) recommendations and General Comments under human rights law).

Globalisation only adds a number of new actors to our analysis in addition to the international society of states, including multinational corporations, non-governmental organisations and public-private partnerships. As international law is still primarily state-centred, it fails to call these actors to account directly. Footnote 9 To accommodate these developments, certain authors have argued in favour of the term ‘global health law’. Footnote 10 While this approach makes a great deal of sense for the above-mentioned reason, this terminology is not congruent with the terms used to address other branches of international law (e.g. international trade law, international environmental law and international humanitarian law). To emphasise the public international law dimension and to avoid a deviation from existing terminology, this article will use the term ‘international health law’ to identify the disciplinary nature of this field. As with the other existing branches of international law, the challenge lies in analysing and explaining how they can offer adequate protection in an era of globalisation, which implies a move away from state-centricity.

2 The rationale for international health law

Before discussing the nature and scope of international health law, the raison d’être of this emerging branch of international law needs to be discussed. Public international law is subject to increasing fragmentation due to the proliferation of its norms and judicial bodies. Footnote 11 So why, then, is there a need to advance international health law as a new branch of international law? And why propose that new legal instruments be adopted in the context of this field?

The article asserts that the protection of health reflects a pressing social need that needs to be given a stronger voice at the international level, within the framework of international organisations. As stressed in the introduction, there is an urgent need for counterbalancing such interests as international trade, industry and commerce and the interests of warfare against the protection of the health of individuals and populations worldwide. To give three concrete examples:

the rights of patients to affordable medicines are often at tension with the recognition of excessive intellectual property rights (i.e. patents) of the pharmaceutical industry; Footnote 12

governmental measures to curb smoking are often counteracted by international trade in tobacco products and excessive advertising for tobacco products;

health workers in armed conflicts are frequently confronted with a disrespect of international humanitarian rules, which hampers them in the exercise of their duties.

International law and health-related international standard-setting instruments have the potential to play an important role in advancing these and other health-related concerns. Beitz describes human rights as norms that reflect ‘urgent individual interests’. For an interest to be ‘urgent’, its protection must be sufficiently important. Moreover, a failure to protect this interest would be a matter of international concern. Footnote 13 The article argues that ‘health’, or ‘good health’, could be identified as an urgent individual interest, the protection of which is important for individuals, while the international community is inclined to step in if this protection fails. Footnote 14

This is not to suggest that a guarantee of ‘good health’ implies that there should be an obligation on the part of the State and other entities to ensure that individuals are completely healthy. In the aftermath of World War II, and probably in a state of post-war idealism, the WHO defined ‘health’ in its Constitution as ‘complete physical, mental and social well-being’. Footnote 15 As Mason Meier explains, with this definition the WHO expanded its mandate far beyond the traditional focus on the ‘absence of disease’ so as to also include public health issues more generally. Footnote 16 While this definition has been lauded for its focus on not only the ‘physical’, but also on ‘mental’ and ‘social’ well-being, it has also been criticised for being too broad and absolute in nature. Footnote 17

More contemporary approaches towards defining health can be associated with the so-called “capability approach”, as developed by Amartya Sen, Martha Nussbaum and, specifically for health, by Sridhar Venkatapuram. Footnote 18 According to Venkatapuram, the capabilities approach is an ‘analytical and ethical framework which asserts that societies should focus on supporting … the capabilities of individuals to conceive, pursue, and revise their life plans’. Footnote 19 The “capability to be healthy” approach, which Venkatapuram proposes, recognises every human being’s moral entitlement to a capability to be healthy. Footnote 20 Along similar lines, others argue that the WHO’s definition of health is increasingly problematic; it would contribute to the medicalisation of society and the definition is counterproductive. Footnote 21 They propose a dynamic definition based more on the resilience or capacity to cope and maintain one’s integrity, equilibrium and sense of well-being. According to Huber and others, the definition should be ‘the ability to adopt and self-manage’. Footnote 22

All in all, health is a vital need that requires strong protection under international law. For international health law, it would be important to focus on the individual’s capacity to function adequately in society and to pursue one’s life plans. Moving away from the absolute WHO definition prevents persons with chronic diseases or disabilities from being labeled as ‘unhealthy’. It also implies that emphasis needs to be placed not only on ensuring access to healthcare services, but also on creating conditions for being healthy, including access to safe drinking water and sanitation, health-related information and education, safe and healthy working conditions, and healthy living environments. The human rights norm that is most closely connected to the protection of health is the right to the highest attainable standard of health, in short, the ‘right to health’. As will be discussed more elaborately below, the right to health is a core human rights norm in the field of international health law as it places the emphasis on the protection of individual health worldwide. It emphasizes the need to strive for equity in health.

3 The sources of international health law

3.1 a bird’s-eye view of the sources.

International health law brings together international standard-setting instruments adopted in the context of the WHO and under human rights law, while health-related legal rules, norms and other (non-binding) standards can also be found in several other branches of international law, including under international humanitarian and environmental laws, in medical ethics and patients’ rights (see also Fig.  1 ). In addition, some instruments have an indirect bearing on health, such as the Trade Related Intellectual Property Rights (the TRIPS) Agreement of the World Trade Organization (the WTO). Footnote 23 For a proper understanding of this emerging field we need to take into account the findings from other related fields in an integrated fashion (section 2 and Fig.  1 ). Footnote 24

An overview of the legal instruments and legal norms under international health law

3.2 The WHO’s legal instrumentarium

Some attention ought to be paid to the standard-setting instruments adopted within the framework of the WHO as it is the main global intergovernmental health body. In fact, the possibilities for the WHO to adopt such instruments are considerable. The Constitution of the WHO provides for the adoption of three different types of instruments: conventions, regulations and recommendations to be found in Articles 19, 21 and 23, respectively. Footnote 25 However, as will be illustrated below, despite these impressive normative powers the WHO possesses, so far, only a limited use of its standard-setting capacity has been made. As Aginam explains, the work of the WHO has for most of its existence been dominated by medical and public health experts, which saw little importance in adopting standard-setting instruments. Footnote 26

Based on Article 19 of the Constitution, the World Health Assembly (the WHA) can adopt conventions and agreements falling within the competence of the organisation. For such instruments to be adopted, a two-thirds vote of the WHA is required. So far, the WHO has only adopted one convention based on this provision, i.e. the FCTC, adopted by the WHA on 21 May 2003, and entered into force on 27 February 2005. Footnote 27 It was developed in response to the globalisation of the tobacco epidemic. As would be expected, the tobacco industry was opposed to the adoption of a treaty, and rather favoured voluntary agreements and regulation by the market. Footnote 28 The FCTC contains price and tax measures to reduce the demand for tobacco. It also has non-price measures, including protection from exposure to tobacco smoke, regulation of the contents of tobacco products, as well as packaging and labelling. As will be discussed below, the FCTC has been applied in several tobacco-related cases at the domestic level. On 12 November 2012, the Parties to the FCTC adopted the Protocol to Eliminate Illicit Trade in Tobacco Products in Seoul, the first protocol to the FCTC. Footnote 29

Article 21 of the WHO Constitution enables the WHA to adopt legally binding regulations concerning, inter alia , sanitary and quarantine requirements, the safety, purity and potency of biological and pharmaceutical products, and the advertising and labelling of biological and pharmaceutical products. For the adoption of these binding regulations, the consent from Member States is not required. Footnote 30 The only sets of regulations that have been adopted in this context, so far, are the so-called ‘Nomenclature Regulations’ Footnote 31 and the ‘International Health Regulations’ (IHR). The latter were adopted in 1969 as a follow-up to the International Sanitary Regulations adopted by the Fourth WHA in 1951, which again date back to a series of European sanitary conferences held in the 19 th Century. Footnote 32 A revised set of IHRs was adopted by the WHO in 2005. Footnote 33 Contrary to the previous Regulations, these new regulations no longer limit their application to specific diseases. Footnote 34 They are essentially aimed at outlining the roles and obligations of the WHO member states when addressing public health emergencies of international concern. Footnote 35 The document contains some cross-connections with human rights law. Footnote 36 For example, Article 3(1) of the Regulations states that their implementation ‘shall be with full respect for the dignity, human rights and fundamental freedoms of persons’, thereby underscoring the importance of human rights protection during public health emergencies.

Article 23 of the WHO Constitution enables the WHA to ‘make recommendations to Members’ and Article 62 requires States to report annually on the action taken to comply with recommendations. The WHO’s most authoritative recommendations are the International Code of Marketing of Breast-Milk Substitutes (1981) and the Global Code of Practice on the Recruitment of Health Personnel (2010). Footnote 37 Despite its non-binding nature, the Breast-Milk Code is an authoritative document that has led 84 countries to adopt domestic legislation implementing the Code. Footnote 38 On the other hand, as asserted by Gostin, the Global Code of Practice on the International Recruitment of Health Personnel has not been as authoritative and has had little impact on domestic laws, policies and practices. Footnote 39 In addition to the recommendations adopted under Article 23 of the WHO Constitution, the WHO has the habit of adopting recommendations outside Article 23. Examples include the WHO’s recommendations on nutrition, on infant feeding and on physical activity for health. Footnote 40

In addition to standard-setting instruments, the WHO has launched a range of international campaigns and it has adopted a considerable number of global strategies. In 1978, the WHO adopted its landmark Alma-Ata Declaration on Primary Health Care, which set the target of providing primary healthcare for all by the year 2000. Footnote 41 While the programme was criticised for inadequate implementation during the 1980s and 1990s, the WHO revitalised it in 2008. Footnote 42 It is also interesting to see that General Comment number 14 on the right to the highest attainable standard of health integrates language from the Alma-Ata Declaration by using the definition of ‘primary healthcare’ for the identification of legal ‘minimum core obligations’ under the right to health. Footnote 43

3.3 Human rights law

International human rights law also plays an important role in international health law. Given that international health law is aimed at the protection of health, the most important human rights norm is the ‘right to the highest attainable standard of health’, in short, the ‘right to health’. Arguably, the right to health features as a core standard in the field of international health law, as it places the emphasis on the protection of individual health worldwide, and because it emphasises the need to strive for equity in health.

The WHO was the first organisation to lay down a right to health. The preamble to the Constitution of the WHO both defines ‘health’ and recognises health as a right. Footnote 44 In connection with the right to health, the Preamble refers to the relation between health problems and unequal development in different countries, to the importance of the healthy development of the child, and to the importance of the informed opinion and active co-operation on the part of the public: notions that still bear relevance today. The adoption of the right to health by the WHO was a breakthrough in the field of international health and human rights law and it created an important point of departure for the further elaboration of a right to health in human rights documents.

The ‘right to health’ in the Constitution of the WHO has inspired the right to health provisions that were drafted at a later stage, in particular Article 12 of the UN International Covenant on Economic, Social and Cultural Rights (the ICESCR). Footnote 45 Article 12 of the ICESCR contains a provision along the lines of the the WHO Constitution. Footnote 46 It recognises the ‘right to the highest attainable standard of health’ and mentions four concrete undertakings for States to realise this goal. In 2000, the Committee on Economic, Social and Cultural Rights (the CESCR) adopted General Comment 14, an explanatory document to the right to health in Article 12 of the ICESCR. Footnote 47 While this document is not legally binding and can thus be characterised as a ‘soft law’ instrument, it is considered authoritative by many scholars and practitioners from the field. Footnote 48 It mentions a range of important signposts for the right to health which are frequently mentioned and applied by human rights scholars, NGOs, and increasingly also by judicial bodies and State authorities. Footnote 49

Firstly, General Comment 14 recognises that the right to health is not a right to be healthy, but rather a broad human right extending not only to access to healthcare services but also to the underlying determinants of health, including an access to safe and potable water and adequate sanitation, healthy occupational and environmental conditions, and access to health-related education and information. Footnote 50

As such, the right to health has two dimensions: a right to healthcare services and a right to a broad set of underlying conditions for health. So it has many cross-connections with the other existing human rights (indirectly) aimed at protecting health, including the rights to education, water and sanitation, and housing. A further important component of General Comment 14 concerns the identification of a set of guiding principles that apply with respect to all health-related services: States are to guarantee the availability, accessibility, acceptability and quality of health facilities (the so-called ‘AAAQ’). Footnote 51

Accessibility has four overlapping dimensions: non-discrimination, physical accessibility, economic accessibility (affordability) and information accessibility. Footnote 52 Furthermore, General Comment 14 defines a set of legal state obligations to ‘respect, protect and fulfil’ human rights and also describes potential violations of states in relation to a right to health. Footnote 53 Lastly, an important component of the General Comment is the definition of a set of legal core obligations resulting from the right to health, minimum essential levels of health services which States have to guarantee ‘at the very least’. Footnote 54 As mentioned above, the minimum core obligations were partly inspired by the WHO’s Primary Health Care Strategy. Footnote 55 This ‘minimum core’ may provide inspiration for the identification of minimum obligations in specific settings such as humanitarian and man-made emergencies or periods of financial crisis.

As was suggested above, the right to health could feature as a key standard in international health law, thus reflecting the need to protect and promote the health of the world’s population. When it comes to applying the right to health in this way, a word of caution is also appropriate. The right to health has rightly been criticised for being imprecise, only progressively realisable and often unenforceable. Footnote 56 There is, thus, an urgent need to study the potentials and limitations of the right to health in this context.

A specific concern is that, in the field of international health law, the right to health would primarily be used as a ‘collective’ norm, protecting the health-related interests of a community or the population at large. The right to health is then understood as a norm that reflects the protection of ‘public health’. It is somewhat problematic to perceive the right to health as a norm that pertains to collective claims; firstly, because as a human right the right to health pertains to an individual rather than to a collective claim. Footnote 57 This does not mean that our existing individual rights cannot lead to collective claims, however. We could perceive the right as materially conferred on individual members of a group, but procedurally looked after by the collectivity. Hence this could potentially be overcome by perceiving the collective right to health as a bundle of individual rights. Footnote 58 An example of a legal mechanism where the right to health and other economic and social rights are exercised in this way is the collective complaints procedure under the (Revised) European Social Charter, which is monitored by the European Committee on Social Rights. Footnote 59

Another concern in the collective exercise of the right to health is that there can be a tension between this presumed public health component of the right to health and the civil and political rights of individuals, including their rights to security, liberty, physical integrity, privacy and family life, but potentially also their individual right to the best possible healthcare. To give one example: in the 2014 Ebola crisis, measures had to be taken for the protection of ‘public health’. However, at the same time, the rights of individual patients and others involved in the crisis had to be respected and protected. Footnote 60 This tension shows that if the right to health is to be employed as a core standard in international health law, more research should go into understanding how it can be applied in a sensible way without undermining the rights of individuals.

In addition to the ‘right to health’, many other human rights are, in one way or another, connected to health, including the right to life, the prohibition of torture as well as the rights to information and education. Footnote 61 Increasingly, therefore, reference is made to ‘health and human rights’ as a distinct field of human rights law, so as to refer to the many intersections between health and the various relevant human rights standards. Footnote 62 Important concerns that are addressed from this perspective include the position of vulnerable persons in healthcare settings, reproductive health issues, medical-ethical issues such as abortion and euthanasia, and the health protection of vulnerable groups such as women, children and the elderly. The emerging human rights field of ‘health and human rights’ plays an important role in international health law.

4 The scope of international health law: three important dimensions

4.1 health security threats.

Traditionally, a key topic of public international law concerned the protection against health security threats. The scope of ‘health security’ has expanded gradually over the course of the previous decennia. While legal efforts to protect against health security threats were initially focused primarily on limiting the spread of infectious diseases, Footnote 63 increasingly other health security threats are addressed as well, including the detrimental health effects of armed conflict and, in relation to this, the need to protect against the use of biological, chemical and nuclear weapons. Footnote 64 While environmental health considerations are potentially also issues of ‘health security’, they are left outside the scope of this section.

The protection against the spread of infectious diseases traditionally forms part of the health-related tasks of national governments. This duty is also formulated under international human rights law: e.g. the right to health in Article 12 ICESCR formulates the duty of States to take measures for the ‘prevention, treatment and control of epidemic, endemic, occupational and other diseases’. Footnote 65

Due to increasing globalisation of infectious diseases, there has been an ongoing and growing need for international coordination in this field. As mentioned above, in 2005 the WHO adopted a new set of International Health Regulations which are aimed at offering protection against a wide range of public health threats. Footnote 66 The recent Ebola crisis has been an important test case for assessing the effectiveness of the new Regulations. While the domestic health systems in the affected countries failed to address the crisis appropriately, a major international response was not put into place. Footnote 67 As will be discussed further below, the WHO lacks the coordinating and financial capacities for dealing adequately with public health emergencies of such a large and complex scale.

For international health law, it is also important to assess the interplay between the Regulations and human rights norms, in particular those pertaining to individual patients and others who may potentially carry on the disease. During health emergencies, the rights of individual patients and others are easily overlooked. While the Regulations seem to incorporate human rights law, the precise implications of this interface at a practical level demand further study. Footnote 68

Furthermore, as mentioned, there is a need to address the connections between health and armed conflict under international health law. It has been stressed on various occasions that war and health influence each other mutually: while health is seen as a preventer of war, war and violent conflict can have a devastating effect on the lives and health of both combatants and civilians. Footnote 69 This means, on the one hand, that by enhancing good health among a population, conflicts could potentially be prevented, hence the need to enhance the health of individuals.

By preventing armed conflicts, health and well-being could be spared. Article 55 of Additional Protocol I (applicable during international armed conflicts) focuses on the protection of the natural environment: ‘Care are shall be taken in warfare to protect the natural environment against widespread, long-term and severe damage. This protection includes a prohibition of the use of methods or means of warfare which are intended or may be expected to cause such damage to the natural environment and thereby to prejudice the health or survival of the population.’ Footnote 70

The notion that weapons can cause severe damage to health is also underlying the weapons’ Conventions, including the Chemical Weapons Convention and the Biological Weapons Convention. Footnote 71 A specific dimension of the connection between health and armed conflicts is that, during armed conflicts, health workers, their hospitals and equipment increasingly become the object of an attack. The ICRC study titled ‘ Healthcare in danger ’ reports that, around the world, people who risk their lives to provide healthcare in conflict areas are under increasing threat. Footnote 72 Potentially, the intertwined fields of human rights law, humanitarian law and medical ethics provide a compelling normative framework for the protection of healthcare provision and the safeguarding of medical neutrality in armed conflicts and other emergency situations. Footnote 73

4.2 Access to healthcare services and the underlying determinants to health

Securing access to access to healthcare services is a key component of the internationally recognised ‘right to health’. Based on the international human right to health, States are required to realise the right to healthcare domestically. Important yardsticks for this realisation are the above-mentioned ‘AAAQ’, requiring that healthcare services are available, accessible, acceptable and of good quality for everyone residing on their territory. Footnote 74 Complex questions arise as to which services should be provided, and where to draw the line, for example, when it comes to more specialized care, healthcare facilities in remote areas and persons not carrying health insurance. While the health problems and needs in developed and developing countries differ to a great extent, at a more abstract level very similar questions arise, for example, on how to allocate the (limited) budgets in a fair and efficient manner, taking into account the needs of the various population groups, as well as individual needs.

Some of these questions have transnational dimensions, for example, when it comes to the affordability of medicines in the developing world and the increasing expansion of cross-border healthcare delivery and financing. Footnote 75 This raises the question of which actors have obligations to realise the right to health. While the State bears the primary responsibility for realising the right to health, developed States and international organisations may carry responsibilities to realise the right to health in developing nations. Footnote 76 Furthermore, the pharmaceutical industry, health insurance companies and healthcare providers, in light of the power and influence they exercise over the health and well-being of individuals, may also be considered to carry responsibilities under the right to health.

As suggested above, the rights of patients also form a component of international health law. In human rights law, patients’ rights are increasingly recognised and addressed. As a result, the field of patients’ rights is becoming a well-established branch of human rights law with its own characteristics. Footnote 77 Patients’ rights focus specifically on the relationship between the healthcare provider and his or her patient. This relationship is quite often characterised by an imbalance of power as, generally speaking, the healthcare provider has information and skills which the patient lacks. Moreover, the healthcare provider has the privilege to touch and invade the body of the patient, thus placing the patient in a vulnerable position. Footnote 78 From a European legal human rights perspective, the European Court of Human Rights (the ECtHR) plays an important role in clarifying how human rights apply in healthcare settings. Footnote 79 More generally, the prohibition of torture and inhuman and degrading treatment, as set forth in several international human rights standards, is increasingly used as a standard of protection in healthcare settings. Footnote 80 As the Open Society Foundations explain:

[A]cross the world, health systems often serve as venues of punishment, coercion, and violations of basic human rights, sometimes amounting to torture or cruel, inhuman, and degrading treatment. This abuse is especially prevalent in the care of socially marginalized groups—people living with HIV, ethnic minorities, sexual and gender minorities, people who use drugs, and people with intellectual disabilities or mental health problems. Footnote 81

In addition to healthcare, international health law should also engage with securing the underlying determinants to health, including such issues as access to safe drinking water and sanitation, health-related information, environmental and occupational health. It is widely acknowledged that the causes of ill-health and health inequalities go far beyond the possibility to access healthcare services. In the well-known ‘Whitehall study’, conducted in the United Kingdom in the 1960s, civil service clerks were four times more likely to die young than civil servants with higher positions but with the same access to healthcare services. Footnote 82 Public health experts use the term ‘social determinants of health’, which are meant to include our general living environment and the structures of society at large as decisive conditions to our health.

In 2008, the WHO’s Committee on the Social Determinants of Health (the CSDH) published a crucial report, in which it established that health inequities arise because of the unequal distribution of power, income, goods and services and because of the circumstances in which people live, including their access to healthcare, education, their conditions of work and leisure, their homes and communities. Footnote 83 The CSDH makes a clear appeal to the international human rights community by concluding that ‘Putting right these inequities – the huge and remedial differences in health between and within countries – is a matter of social justice. Reducing health inequities is … an ethical imperative. Social injustice is killing people on a grand scale.’ Footnote 84

Important challenges lie in exploring how the social determinants of health can be addressed from the perspective of human rights and international law more generally. Part of the solution may lie in connecting the different human rights together. Knowing that the ways we are raised, educated and work are decisive to our health implies looking into how the right to health is connected to other health-related rights, including the rights to education, housing and work, which reflect values like good quality education and adequate labour standards. This approach is very much in keeping with the notion of the ‘indivisibility, interdependence and interrelatedness’ of all human rights, as was affirmed in the Vienna Declaration and Programme of Action, adopted in 1993. Footnote 85

A related challenge for international health law concerns the dramatic global increase of chronic or non-communicable diseases (the NCDs) such as cancer, diabetes, respiratory diseases and cardiovascular conditions. The NCDs accounted for 65 per cent of global death in 2010 and are set to rise by 17 per cent over the next decade. Footnote 86 Non-communicable diseases are set to increase disproportionately in low and middle-income countries over the next 20 years, which is expected to enhance poverty and to reduce economic growth. Footnote 87 As chronic diseases are quite often lifestyle-related, the question arises if, and if so how, governments should attempt to influence the consumption patterns of consumers or, in other words, whether they should ‘nudge’ their population towards healthier behaviour. Footnote 88

At the domestic level, governments increasingly attempt to regulate certain aspects of food and beverages, such as the advertisement, packaging, size, and salt, sugar and (trans) fat content. Footnote 89 Potentially also, governments have responsibilities under the right to food and the right to health to regulate the food and beverage industries. In addition, the food and beverage producers themselves, although strictly speaking not legally bound by the human rights treaties, potentially have indirect responsibilities under human rights law to ensure the healthiness of their products. Footnote 90 From the perspective of international health law, the possibilities for adopting an international instrument addressing these matters could be considered. Footnote 91

4.3 Health and international trade

As was already pointed out above, there are many connections between the international trade law framework and the international health-related standards, often leading to a tension between the urge to foster international trade and the need to protect the health of the public. Footnote 92 While it goes beyond the scope of this article to give a comprehensive overview of all these dimensions, three important tensions are discussed here.

Firstly, the WTO law gives Members the possibility to adopt measures for the protection of public health. The General Agreement on Tariffs and Trade (the GATT), which covers international trade in goods, permits Member States in Article XX(b) GATT to take measures ‘necessary to protect human, animal or plant life or health’. This provision, which creates a tension with the principle of non-discrimination mentioned above, recognises that Members may wish to give priority to public health concerns. Footnote 93 More specific rules for the protection of health have been adopted under the Agreement on Sanitary and Phytosanitary Measures (the SPS). This Agreement regulates ‘sanitary measures’, which relate to human or animal health, and ‘phytosanitary measures’, which deal with plant health.

The relationship between this framework and the human rights framework is still under-explored. While members invoking these public health clauses could potentially invoke the right to health, Members barred from trading their goods based on such measures could possibly stress the right to development of their people. It is important to strike a balance between allowing Members to protect public health or other social interests and preventing them from using these policies in such a way that they have a negative effect on trade and on the interests of the other Members. Footnote 94

Secondly, there is potentially a tension between the realisation of the right to healthcare at the domestic level, and the liberalisation and marketization of healthcare services. While privatisation and liberalisation can make the provision of healthcare more efficient, it may also place the affordability and accessibility of healthcare under threat. Footnote 95 More specifically, looking at the WTO framework, the Trade in Services (the GATS) is aimed at the liberalisation of trade in services. This potentially threatens the ability of State to realise the right to healthcare at the domestic level. According to Hilary in a study for Save the Children, the specific provisions of GATS undermine the ability of countries to implement their own public health priorities. Footnote 96 These tensions merit further attention from international health lawyers.

Thirdly, the trade regime can create a tension with the need to ensure access to affordable medicines, especially in the developing world. It is estimated that almost 2 billion people lack access to essential medicines. Footnote 97 The availability and affordability of drugs in developing countries are hampered by the TRIPS Agreement which requires for 20 years’ of patent protection of newly developed drugs. This regime has, therefore, been criticized widely for not respecting the right to health. Footnote 98 However, the landmark ruling of the Indian Supreme Court, Novartis AG v Union of India , attempts to balances the trade – particularly intellectual property concerns – with health concerns to offer a blueprint of international health law. Aftab Alam J wrote lucidly to express a juristic concern for patients in low-income countries balancing, at the same time, India’s intellectual property commitments and global welfare concerns:

[The India Supreme Court … refers … to the TRIPS] Agreement as being the cause of a good deal of concern not only in this country but also … in other parts of the world; the concern being that patent protection to pharmaceutical … products might have the effect of putting life-saving medicines beyond the reach of a very large section of people. [T]he Indian legislature [has] addressed this concern and, while harmonizing the [Indian] patent law … with the provisions of the TRIPS Agreement, [India has ] strove to balance its obligations under the international treaty and its commitment to protect and promote public health considerations, not only of its own people but in many other parts of the world (particularly in the [d]eveloping … and the [l]east [d]eveloped [c]ountries). Footnote 99

Such rulings can have a considerable impact on the health-related instruments and norms in international law. After all, judicial decisions are seen sources of international law. Footnote 100 It is remarkable that the Indian Supreme Court, while noting India to be the “pharmacy of the world”, cited a number of countries where cheap drugs from India help in fighting cancer. Admirably enough, the Supreme Court’s concern was not local but international. Footnote 101

5 Towards accountability of responsible actors

5.1 domestic and international accountability.

After this identification of the relevant standard-setting instruments and their potential application in practice, I will now analyse the way in which these instruments are implemented, monitored and enforced by the responsible actors. These questions are closely connected to the notion of governance which could, in this context, be defined as the totality of ways in which a society organises and manages its health-related concerns. Footnote 102 In the context of international health law, a distinction can be made between domestic and global health governance, where domestic health governance concerns the totality of efforts at the national level, whereas global health governance refers to the efforts at the international level geared towards protecting and promoting health. To some extent this distinction is artificial, as global and national health laws are very much intertwined; however, it may help us gain a clearer picture of the nature and adequacy of the existing efforts at various levels of governance and accountability.

Ultimately, the aggregate of such efforts should lead to what is also addressed as ‘good governance’, i.e. ensuring that the efforts geared towards the protection and promotion of health at both international and national levels are transparent, accountable and participatory, taking into account the relevant human rights, humanitarian and ethical standards. Footnote 103 Key components of a good governance process include participation, the rule of law, transparency, responsiveness, equity, effectiveness and efficiency, and accountability. Footnote 104 Human rights law emphasises similar principles, in particular the notions of accountability and participation. However, there is still a lack of understanding as to what it means to create ‘accountability’ for human rights violations, for example, and of how ‘participation’ can be enhanced, for example, in the decision-making process over important decisions in the health sector. Footnote 105 When it comes to health service delivery more specifically, more specific principles include the above-mentioned ‘AAAQ’, requiring that health services are available, accessible, acceptable and of good quality. Footnote 106

5.2 Domestic health governance

States, the primary duty holders under public international law, have certain legal obligations to enhance the health of their population. Based on the right to health, they have the duty to realise the highest attainable standard of health of all individuals residing on their territory (and potentially beyond). They should also realise the other health-related rights as well as the rights of patients. Among other things, this means that the State is under a duty to establish a national public health strategy and plan of action. Footnote 107 For a State to adopt a national public health strategy and plan of action, it must have a properly functioning health system. Footnote 108

To some extent, States have a duty to regulate non-state actors, hence to regulate all the actors in the health sector, varying from (public and private) health insurance companies, hospitals, pharmaceutical companies, to pharmacists, and general practitioners, to the pharmaceutical industry and the food and beverage industry. To bring this back to human rights law: States are under a ‘duty to protect’ the health and well-being of individuals against the human rights violations of non-state actors. The (non-binding) General Comment 14 on the Right to the Highest Attainable Standard of Health explains that:

Violations of the obligation to protect follow from the failure of a State to take all necessary measures to safeguard persons within their jurisdiction from infringements of the right to health by third parties. This category includes such omissions as the failure to regulate the activities of individuals, groups or corporations so as to prevent them from violating the right to health of others; the failure to protect consumers and workers from practices detrimental to health, e.g. by employers and manufacturers of medicines or food; the failure to discourage production, marketing and consumption of tobacco, narcotics and other harmful substances; the failure to protect women against violence or to prosecute perpetrators; the failure to discourage the continued observance of harmful traditional medical or cultural practices; and the failure to enact or enforce laws to prevent the pollution of water, air and soil by extractive and manufacturing industries. Footnote 109

This paragraph provides many important examples of how the State is entitled to regulate non-state actors in the field of health. At the same time, it is increasingly recognised that the protection and promotion of health involve a shared responsibility, or a multi-stakeholder approach. General Comment 14 recognises that:

While only States are parties to the Covenant and thus ultimately accountable for compliance with it, all members of society – individuals, including health professionals, families, local communities, intergovernmental and non-governmental organizations, civil society organizations, as well as the private business sector – have responsibilities regarding the realization of the right to health […]. Footnote 110

This statement recognises that many different actors have responsibilities under the right to health – setting aside the question of whether such responsibilities are legal or moral in character.

It is interesting to see that, along similar lines, the WHO’s legally binding International Health Regulations stipulate that the realisation of the Regulations should be a joint effort, consisting of the State as the primary duty holder and other actors offering support. Based on the Regulations, States are under an obligation to maintain core surveillance and response capacities (Articles 5(1) and 13(1)), while the WHO shall assist States in this task (Articles 5(3) and 13(3)). When requested by the WHO, other States Parties should provide, to the extent possible, support to the WHO-coordinated response activities (Article 13(5)). These international bodies increasingly recognise that a multi-stakeholder approach should be taken to achieve health at the national level.

When it comes to enforcing the health-related instruments, States should ensure that accountability mechanisms are in place to hold responsible actors accountable for their failure to respect and to realise the instruments. It is increasingly recognised that creating accountability for violations of international (human rights) standards is a multi-faceted process which should not rely on (quasi)judicial accountability mechanisms only, but also on a wide range of non-judicial tools, including political, professional, social, financial and administrative accountability mechanisms. Footnote 111 Without discussing these mechanisms in detail, it would be important to facilitate the participation of a wide range of different actors in the implementation process of the instruments under international health law, including civil society groups, the media, national parliaments and professional societies. An example of a case where there was considerable cross-fertilization between civil society and the court system is the well-known Treatment Action Campaign case, which addressed access to an anti-retroviral drug in South Africa. After a broad campaign by the Treatment Action Campaign, the matter was put before the South African Constitutional Court which decided that the unavailability of the drug to the population at large violated the right to health in the Constitution of South Africa. Footnote 112

The Framework Convention on Tobacco (FCTC) has featured in cases before several domestic courts, including in Australia, Peru and the Netherlands. Footnote 113 In September 2014, the Dutch Youth Smoking Prevention Foundation started legal proceedings against the Kingdom of the Netherlands to ‘end the structural and excessive influence exerted by the tobacco lobby on government anti-smoking policies’. The case was based on Article 5(3) of the FCTC and the ensuing guidelines, which require States Parties to protect their anti-tobacco policies from commercial and other vested interests of the tobacco industry. Footnote 114 In addition, the case relied on the right to health in the Dutch Constitution and international treaties that the Netherlands is a party to. This case creates an interesting precedent for similar cases in which the interests of public health are balanced against the interests of international trade.

A new case law digest on ‘health and human rights’ provides many interesting examples of cases addressed at the domestic level, before judicial and quasi-judicial bodies, from different parts of the world. Footnote 115 It turns out that most successful cases have involved access to essential services and medicines. Footnote 116 While most cases occurred in Latin American countries, South Africa and India, domestic courts in Western states are still reluctant to adjudicate cases on the basis of the health-related rights. Such cases set important examples on domestic judicial enforcement of the right to health and other health-related international instruments and norms. Footnote 117

5.3 Global health governance

The primary intergovernmental body in the global health field is the WHO. However, due to increasing globalisation, the WHO has now been joined by many players. Footnote 118 Other organisations that play a role in international governance for health include the International Labour Organization (the ILO), the United Nations Development Programme (the UNDP), the United Nations Children’s Fund (the UNICEF), the Global Fund for AIDS, Malaria and Tuberculosis, the World Bank and the International Monetary Fund (the IMF), regional development banks and the World Trade Organization. Important private actors are the pharmaceutical industry, the Bill and Melinda Gates Foundation, a wide range of public-private partnerships which have been established to address infectious diseases, as well as NGOs including Médecins sans Frontières and Oxfam. Footnote 119 In relation to disaster relief and humanitarian assistance in times of emergencies specifically, the Office of the United Nations High Commissioner for Refugees, the International Committee of the Red Cross/Red Crescent and the UNICEF, as well as non-governmental organisations and national medical associations, are of particular importance, including assistance to refugees and internally displaced persons play an important role. Footnote 120

While these new organisations bring in important new experiences and resources, the existence of so many organisations together also creates a considerable level of miscommunication and a lack of adequate leadership and accountability. Footnote 121 As the central organisation for international governance for health, the WHO is to play a key role in coordinating these different organisations. Footnote 122 However, the WHO has frequently been criticised for failing to show leadership in this regard. Footnote 123 More specifically during the 2014 Ebola crisis, the WHO was criticised for downplaying the situation and for failing to demonstrate leadership in addressing the outbreak. Footnote 124 It should also be noted that the WHO lacks sufficient resources to address such global health problems. Footnote 125 While fees paid by Member States are limited, voluntary contributions declined after the economic crisis. Footnote 126

To address the global health governance deficit, several scholars and civil society organisations have called for a strengthening of the WHO, for more standard-setting in global health and for more resources to address global health problems. Footnote 127 When it comes to adopting legal instruments, a global coalition of civil society and academics – the Joint Action and Learning Initiative on National and Global Responsibilities for Health (JALI) – has formed an international campaign to advocate for a Framework Convention on Global Health (FCGH). Footnote 128 Alongside this initiative it has been suggested that an international fund for health should be established which would ensure that there are sufficient resources to take effective international measures. Footnote 129 Ooms and Hammonds have argued in favour of a Global Fund for Health (along the lines of the existing Global Fund for AIDS) which would allow for the monitoring of contributions of all high income countries to ensure that all countries in need of assistance would receive aid, provided that they have made ‘best efforts’. Footnote 130 These initiatives are evidence of a growing wish to boost the global efforts towards health protection.

6 International health law: challenges for an emerging field

This article has attempted to bring coherence to the international standard-setting instruments and norms relevant to health. It has been done to outline the content and the scope of international health law as an emerging branch of international law. The article has shown that international health law consists of a set of disjointed health-related instruments that have been adopted within the framework of various international organisations, including the WHO, human rights treaty-monitoring bodies and the ICRC.

The implementation and enforcement of international health law remain a huge challenge. A major difficulty will be in bringing coherence to a field that is very broad and relies on instruments and norms from various branches of international law. While it is important to recognise many dimensions of health and, as such, to go beyond mere ‘physical well-being’ and the ‘absence of disease’, there is a danger that, as a result of this approach, the field becomes too broad and thus loses its effectiveness and overall significance. In this context it has been suggested that the ‘right to health’ could be recognised as the key unifying standard in the field of international health law. It would place the health-related interests of individuals at the centre of the debate. While this norm has many flaws, it currently seems to be the best available standard, with its emphasis on health justice and equity.

In addition to bringing coherence to existing instruments, it has been suggested that new standard-setting instruments could be adopted under international health law. In this context, I suggest that WHO, as the main intergovernmental body in the field of health, should make more effective use of its standard-setting capacity. Footnote 131 An initiative that aims to advance global justice in health more generally is the proposed Framework Convention on Global Health. While it raises many conceptual and legal questions, many of them difficult to realise, it nonetheless forms an important call on States and the international community to address the vast health inequalities that exist in our world today. Footnote 132 Along the lines of the FCTC, more specific new instruments could focus on such issues as the world obesity pandemic and the related responsibilities of the food and beverage industries.

Finding ways to move beyond the State-centred nature of public international law and international health law more specifically remains a challenge. In the protection of health, globally and locally, many state and non-state actors interact with each other forming a complex relationship. Additionally, the WHO might play a role in enhancing transparency and accountability among all the actors involved.

Implementation of the instruments at the domestic level is certainly a major goal. Adoption of good-quality health legislations at the domestic level might serve a good start. Countries can learn from the Indian court’s ruling in the Novartis case. A purported international health law can play an important role by framing the key norms and principles that ‘good’ domestic health legislation should reflect. Footnote 133 Scholars and international non-governmental institutions, in particular the WHO, could make a concerted effort to develop domestic model legislation for the health field, in light of the international legal standards. Footnote 134 This domestic model legislation could focus on, inter alia , access to essential medicines and access to maternal and obstetric care, but also on social health insurance and/or social determinants for health such as food standards like sugar and salt intake.

Tikki Pang & G Emmanuel Guindon, Globalization and risks to health, 5(Suppl 1) EMBO Rep (October 2004) S11–S16.

See also the comprehensive article by Lawrence O Gostin & Allyn L Taylor, Global Health Law: A Definition and Grand Challenges, 1(1) Pub Health Ethics (2008) 53–63.

WHO, Non-communicable diseases < http://www.who.int/mediacentre/factsheets/fs355/en/ >. Accessed November 2015.

WHO, Commission on the Social Determinants of Health, Closing the Gap in a Generation , Health Equity through Action on the Social Determinants of Health (WHO, Geneva, 2008).

See, World Bank, The Climate Change, Environment and Natural Resources Management < http://web.worldbank.org/WBSITE/EXTERNAL/WBI/WBIPROGRAMS/ENRLP/0,,contentMDK:20242344~pagePK:64156158~piPK:64152884~theSitePK:460957,00.html > accessed November 2015.

WHO, non-communicable diseases, see supra note 4.

See also, Gostin & Taylor, 2008, supra note 2, 53–63.

See also, Michel Bélanger, Une nouvelle branche du droit international: le droit international de la santé, Etudes internationals Québec (1982) 611–632.

Gostin & Taylor, supra note 2, 53–63.

For an authoritative study, see Lawrence O Gostin, Global Health Law (Harvard Univ Press, Cambridge, 2014); Obijofor Aginam , Global Health Governance: International Law and Public Health in a Divided World (Toronto: University of Toronto Press, 2005); Michel Bélanger, Global Health Law: An Introduction (Cambridge Scientific Pub, Cambridge 2011).

On the issue of fragmentation, see, among other papers in the issue, Gerhard Hafner, Pros and Cons Ensuing from Fragmentation of International Law, 25 Mich J Intl L (2003–2004) 845.

Prabhakar Singh, No roses without Thorns: global consumers of cut flowers as political actors, 6 Kentucky J Equine, Agriculture & Natural Resources L (2013–2014) 23–57, 25.

Charles C Beitz, The Idea of Human Rights (OUP, Oxford, 2009) 137.

Toebes, Introduction, in, Brigit Toebes et al, Health and Human Rights in Europe ,(Intersentia, Antwerp, 2012), 13, 15–16.

Preamble to the Constitution of the World Health Organization, 22 July 1946 (entry into force 7 April 1948).

Benjamin M Meier, The World Health Organization, The Evolution of Human Rights, and the Failure to Achieve Health for All, in, John Harrington & Maria Stuttaford (eds) Global Health and Human Rights – Legal and Philosophical Perspectives (Routledge, Abingdon, 2010) 163–183 [166].

For example, see the discussion at the website of the Dutch organization ZonMw < http://www.zonmw.nl/nl/over-zonmw/begrip-gezondheid/ > accessed November 2015.

Amartya Sen, Development as Freedom (OUP, Oxford, 1999); Martha Nussbaum, Creating Capabilities: The Human Development Approach (Harvard University Press, Cambridge, 2011); Sridhar Venkatapuram, Health Justice: An Argument for the Capabilities Approach (Polity Press, Cambridge/Malden, 2011).

Venkatapuram, Ibid, 113–115.

Machteld Huber et al, How Should We Define Health, 343 BMJ (2011) d4163.

In Novartis AG v Union of India , MANU/SC/0281/2013 [65], the Indian Supreme Court said that the ‘Doha Declaration effectively reflected and addressed the deep disquiet of the developing and the least-developed countries regarding their obligation under TRIPS to grant patent protection for pharmaceutical … products and the likelihood of its highly adverse consequence on public-health.’

See also Allyn Taylor, Governing the Globalization of Public Health, 32(3) J Law, Medicine & Ethics (2004) 500–508.

See also Obijiofor Aginam, Mission (Im)possible, The WHO as a ‘Norm Entrepreneur’ in Global Health Governance, in Michael Freeman, Sarah Hawkes & Belinda Bennett, eds, Law and Global Health: Current Legal Issues Volume 16 (OUP, Oxford, 2014) 560–573. See also Gostin, supra note 10, 110, 116.

Aginam, Ibid, 562.

For the text of the Convention, see < http://whqlibdoc.who.int/publications/2003/9241591013.pdf > accessed January 2015. See also, Ruth Roemer, Allyn Taylor & Jean Lariviere, Origins of the Framework Convention on Tobacco Control, 95(6) American J Pub Health (2005) 936–938.

Roemeret al, Ibid, 237.

For the text of the Protocol, see < http://apps.who.int/iris/bitstream/10665/80873/1/9789241505246_eng.pdf > accessed November 2015. As at November 2015, the Protocol has 54 signatories and only 11 ratifications. For an evaluation, see Jonathan Liberman, 16(31) ASIL Insight < https://www.asil.org/insights/volume/16/issue/38/new-who-fctc-protocol-eliminate-illicit-trade-tobacco-products > accessed November 2015.

See the ‘contracting out’ procedure in Article 22.

WHO, World Health Organization Regulations No. 1 regarding Nomenclature (including the Compilation and Publication of Statistics) with respect to Diseases and Causes of Death , adopted on 24 July 1948 and amended in 1956 and 1967.

Gostin, supra note 10, 111.

WHO, Fifty-Eight World Health Assembly, Revision of the International Health Regulations, W.H.A. Doc. 58.3 (May 23, 2005). Entry into force 15 June 2007 < http://www.who.int/ihr/9789241596664/en/index.html > accessed November 2015.

Article 2 of the International Health Regulations and its Preamble.

International Health Regulations, see also Eric Mack, The World Health Organization’s New International Health regulations: Incursion on State Sovereignty and Ill-Fated Response to Global Health Issues, 7 Chi J Intl L (2006–2007) 365–377, 369.

For an elaborate analysis of these cross-connections, see Andraž Zidar, WHO International Health Regulations and Human Rights: From Allusions to Inclusion, 19(4) Intl J Human Rights (2015) 505–526.

WHO, International Code of Marketing of Breast-Milk Substitutes (1981) < http://www.who.int/nutrition/publications/code_english.pdf > accessed November 2015; Global Code of Practice on the Recruitment of Health Personnel (2010) < http://www.who.int/hrh/migration/code/WHO_global_code_of_practice_EN.pdf > accessed October 2015.

Gostin, supra note 10, 105.

Generally, see < www.who.int > accessed November 2015.

WHO, Declaration of Alma-Ata, Primary Health Care , Report of the International Conference on Primary Health Care, Alma-Ata, USSR, 6–12 September 1978, ‘Health for All’ Series No 1, WHO, Geneva/New York, 1978.

WHO, Return to Alma-Ata , 2008 < http://www.who.int/dg/20080915/en/ > accessed November 2015.

Interpreting Article 12 of the UN International Covenant on Economic, Social and Cultural Rights (ICESCR). General Comment 14 [43–44].

Preamble to the Constitution of the World Health Organization, adopted 22 July 1946 (entry into force 7 April 1948).

Other right to health provisions can be found, inter alia, in Article 12 of the Convention on the Elimination of all forms of Discrimination against Women (CEDAW, 1979) and Article 24 of the Convention of the Rights of the Child (CRC, 1989). While 12 CEDAW focuses primarily on access to healthcare for women, Article 24 CRC covers the broader right to health of children, in referring not only to healthcare facilities, but also to adequate food, drinking water and prohibition of harmful traditional practices. In addition to the above-mentioned provisions, a number of other UN treaties and declarations exist that refer to a right to health. In addition, the Convention on the Protection of the Rights of All Migrant Workers and Members of their Families (MWC, 1990) places emphasis on equal access to medical care for migrant workers. Article 5(e)(iv) of the Convention on the Elimination of All Forms of Racial Discrimination (CERD, 1965) is slightly more elaborate, in that it provides in general terms that States Parties are to prohibit and eliminate racial discrimination in the enjoyment of public health, medical care, social security and social services. Also worth mentioning are Rules 22 to 26 of the Standard Minimum Rules for the Treatment of Prisoners (1957), which lay down a number of principles for the treatment of sick prisoners. Finally, the Conventions of the ILO contain numerous references to a specific area of health, namely occupational health. Different in character is Article 25 of ILO Convention No. 169 (1989), which explicitly recognises a right to health of indigenous and tribal peoples. Lastly, worth mentioning is the Convention on the Rights of Persons with Disabilities (CRPD, 2006), which contains several references to the health of disabled persons, including Article 25 on the right to health of disabled persons.

Brigit Toebes, The Right to Health as a Human Right in International Law (Intersentia/Hart, Antwerp/Oxford, 1999) 43.

Committee on Economic, Social and Cultural Rights, The Right to the Highest Attainable Standard of Health , UN General Comment No 14 (2000), UN Doc E/C12/200/4 (11 August 2000).

See, for example, the reference to Genera, Comment 14 on the website of the Special Rapporteur on the Right to the Highest Attainable Standard of Health, < http://www.ohchr.org/EN/Issues/Health/Pages/SRRightHealthIndex.aspx > accessed November 2015. See also Paul Hunt, Health and Human Rights Project < https://www.essex.ac.uk/hrc/practice/health-and-human-rights.aspx > accessed November 2015.

See also Helen Potts, Accountability and the Right to the Highest Attainable Standard of Health , University of Essex Human Rights Centre/Open Society Institute < http://repository.essex.ac.uk/9717/1/accountability-right-highest-attainable-standard-health.pdf > accessed November 2015.

General Comment 14 supra note 47 [8, 11].

Ibid, [12].

Ibid, [33–37].

Ibid, [43–44].

WHO, Declaration of Alma-Ata , 6–12 September 1978. < http://www.who.int/publications/almaata_declaration_en.pdf > accessed December 2015.

Gostin, supra note 10, xv.

Brigit Toebes, Human Rights and Public Health: Towards a Balanced Relationship, 19(4) Intl J Human Rights (2015) 488–504. Also, < http://www.who.int/publications/almaata_declaration_en.pdf > accessed December 2015.

Marlies Galenkamp, Collective Rights, in, SIM Special No 16 (Netherlands Institute of Human Rights, Utrecht, 1995) 53–102, 70–71. See, Toebes, Ibid, 55.

European Committee of Social Rights (Council of Europe), Collective Complaints Procedure < http://www.coe.int/t/dghl/monitoring/socialcharter/Complaints/Complaints_en.asp > accessed October 2015.

Toebes, supra note 57; Zidar, supra note 36.

The so-called ‘International Bill of Human Rights’ embraces the Universal Declaration of Human Rights (UDHR, 1948), the International Covenant on Civil and Political Rights (ICCPR, 1966) and the International Covenant on Economic, Social and Cultural Rights (ICESCR, 1966). The UDHR, which contains both civil and political rights and economic, social and cultural rights, recognises a right to an adequate standard of living (Article 25), which includes a right to medical care and necessary social services. While the ICCPR contains a number of health-related civil and political human rights, including the right to life and the prohibition of torture, the ICESCR recognises in Article 12 the ‘right to the highest attainable standard of health’. Subsequently, a number of UN human rights treaties were gradually adopted that integrate civil and political rights and economic, social and cultural rights.

Toebes et al, supra note 14, in particular Chapter 3.

Sophie Harman, Global Health Governance : No 60 (Routledge Global Institutions Series, Abingdon, 2012) 19–23.

Harman, supra note 63, 21, referring to David Fidler & Lawrence Gostin, Biosecurity in the Global Age: Biological Weapons, Public Health and the Rule of Law (Stanford Univ Press, Stanford, 2008).

E.g. Jos Dute, De bestrijding van infectieziekten in een veellagige rechtsorde [Combating infectious diseases in a multi-layered legal order], in, AC Hendriks & H-MThD Ten Napel (eds) Volksgezondheid in een veellagige rechtsorde, Eenheid en verscheidenheid van norm en praktijk (Kluwer, Alphen aan den Rijn, 2007) 123–136 (emphasis added).

The WHO, Fifty-Eight World Health Assembly, Revision of the International Health Regulations, W.H.A. Doc. 58.3 (May 23, 2005) (Entry into force 15 June 2007) < http://www.who.int/ihr/9789241596664/en/index.html > accessed November 2015.

See this author’s blog post The ebola crisis: challenges for global health law (posted 3 February 2015) < https://ghlgblog.wordpress.com/2015/02/03/the-ebola-crisis-challenges-for-global-health-law/ > accessed November 2015.

For a thorough analysis, see Zidar, supra note 36.

Harman, 2012, 20, referring to Joanna Santa Barbara & Graeme MacQueen, Peace through Health: Key Concepts, 364 Lancet (2004) 384–386.

Article 55 Additional Protocol I to the Geneva Conventions, adopted 8 June 1977.

Biological Weapons Convention, opened for signature on 10 April 1972; Convention on the Prohibition of the Development, Production, Stockpiling and Use of Chemical Weapons and on their Destruction, adopted 30 November 1992; Biological Weapons Convention, opened for signature on 10 April 1972.

ICRC, Healthcare in Danger < http://www.redcross.int/EN/mag/magazine2011_2/4-9.html > accessed November 2015.

Brigit Toebes, Health and Humanitarian Assistance: Towards an Integrated Norm under International Law, 18 Tilburg L Rev (2013) 133–151.

General Comment 14, supra note 47 [12].

Directive 2011/24 of the European Parliament and of the Council on the Application of Patients’ Rights in Cross-Border Healthcare, OJ 2011 L 88/45. For a critical comment, see BMJ Editorial 203/347, published 31 December 2013 < http://www.bmj.com/content/347/bmj.f7694 >. See also Janne Rothmar Herrmann and Brigit Toebes, The European Union and Health and Human Rights, in Toebes et al, supra note 14, 51–78, in particular pp. 66–67.

For this, a basis is often sought in Article 2(1) ICESCR.

See also Mette Hartlev, Patients’ Rights, in Toebes et al, supra note 14, 111–144.

Elizabeth Wicks, Human Rights and Healthcare (Hart, Oxford and Portland, 2007), referring to I Kennedy, Treat Me Right: Essays in Medical Law and Ethics (Clarendon Press, Oxford, 1991) 387.

See also Aart Hendriks, The Council of Europe and Health and Human Rights, in Toebes et al, supra note 14, 23–50.

Open Society Foundations, Twenty Mechanisms for Addressing Torture in Healthcare, June 2012 < http://www.opensocietyfoundations.org/publications/twenty-mechanisms-addressing-torture-health-care > accessed January 2015. See also Veelke Derckx, Antenor Hallo de Wolf & Brigit Toebes, Implementing the Torture Convention: protecting human dignity and integrity in healthcare , report (in Dutch and English) August 2013 < http://www.rug.nl/research/groningen-centre-for-law-and-governance/programmas/public-trust-and-public-law/osi-project/opcat-implementation-in-health-care-settings-in-the-netherlands?lang=en > accessed November 2015.

Open Society Foundations (OSF) 2012.

As quoted in, inter alia , Michael Marmot, The Status Syndrome: How Social Standing Affects Our Health and Longevity (Henry Holt and Company, New York, 2004) 38–39.

The WHO, Commission on the Social Determinants of Health (CSDH), Closing the gap in a generation: health equity through action on the social determinants of health. Final Report of the Commission on Social Determinants of Health , 2008 < http://www.who.int/social_determinants/thecommission/finalreport/en/index.html >. Accessed November 2015.

Vienna Declaration and Programme of Action , UN Doc A/Conf.157/23 (12 July 1993) [5]. See also M. Marmot et al, WHO European Review of Social Determinants of Health and the Health Divide , The Lancet , 380 (2012) 1011–29.

Gostin, 2014, referring to Rafael Lozano et al, Global and Regional Mortality from 235 Causes of Death for Twenty Age Groups in 1990 and 2010: A Systematic Analysis for the Global Burden of Disease Study 2010, 380 The Lancet (2012) 2095–2128.

Consumers International and World Obesity Forum, 2014.

Cass R Sunstein, Why Nudge – The Politics of Libertarian Paternalism (Yale Univ Press, New Haven & London, 2014).

Allyn A Taylor, Emilio W Parento & Laura A Schmidt, The Increasing Weight of Regulation: Countries Combat the Global Obesity Pandemic, 90(1) Indiana L J < http://scholarship.law.georgetown.edu/cgi/viewcontent.cgi?article=2338&context=facpub > accessed September 2015.For example, the restriction on the sale of large sugary drinks in NY City, New York Times , Health panel approves Restriction on Sale of Large Sugary Drinks, September 13, 2002 < http://www.nytimes.com/2012/09/14/nyregion/health-board-approves-bloombergs-soda-ban.html?smid=tw-share&_rmoc.semityn.www&_r=0 > accessed September 2015.

See, for example, Conference Statement Food Corporations and Human Rights, 11–12 September 2014 < http://www.uio.no/english/research/interfaculty-research-areas/leve/news-events/events/2014/global-food-systems-hr/final-statement-from-oslo-conference-071014.pdf > accessed September 2015.

For an initiative in this regard, see Consumers International and World Obesity Forum, Recommendations Towards a Global Convention to Protect and Promote Healthy Diets , May 2014 < www.worldobesity.org >. Accessed November 2015. See also Urgently Needed: A Framework Convention for Obesity Control, 387 The Lancet 378 (2011) 741.

See in details, Singh, supra note 12, 57.

WTO Agreements & Public Health, 2002, 11.

Simon Lester, Bryan Mercurio & Arwel Davies, World Trade Law , (2 nd end Hart Publishing 2012) 364.

Brigit Toebes, The Right to Health and the Privatization of Health Care Services: A Case Study of the Netherlands, 9(1) Health & Human Rights (2006) 102–127.

John Hilary, The Wrong Model, GATS, Trade Liberalization and Children’s Right to Health, Save the Children 2001. See also André den Exter, GATS en de Zorgverzekeringswet: een controverse?, in, AC Hendriks & H-MThD Ten Napel (eds), supra note 65, 63–76.

The WHO, Medicines Strategy: Countries at the Core, 2004–2007 (WHO, Geneva, 2004). See also Paul Hunt & Rajat Khosla, The Human Right to Medicines, 5(8) Sur: Intl J Human Rights (2008) 99–115.

TRIPS Agreement, signed in Marrakesh, Morocco, on 15 April 1994. Inter alia , Paul Hunt, Mission to the World Trade Organization, 2004; Gabriela Costa Chaves, Marcela Fogaça Vieira & Renata Reis, Access to Medicines and Intellectual Property in Brazil: Reflections and Strategies of Civil Society, 5(8) SUR – Intl J Human Rights (2008) 163–189; Nathan Ford, David Wilson, Onanong Bunjumnong & Tido von Schoen Angener, The Role of Civil Society in Protecting Public Health over Commercial Interests: Lessons from Thailand, 363 Lancet (2004), 560.

Novartis AG v Union of India, MANU/SC/0281/2013 [66].

ICJ Statute Article 38(1)(d) < http://www.icj-cij.org/documents/?p1=4&p2=2 > accessed 28 Jan 2016.

Prabhakar Singh, India before and After the Right of Passage case, 5 Asian J Intl L (2015) 176, 203–205.

Julio Frenk & Suerie Moon, Governance Challenges in Global Health, 368 New England J Med (2013) 936–942, March 7, 2013, referring to United Nations Development Programme, Governance for Sustainable Human Development (UNDP, New York, 1997).

E.g. UNDP: ‘it is … among other things participatory, transparent and accountable. It is also effective and equitable. And it promotes the rule of law.’ (UNDP, 1997).

Helen Potts, supra note 49; Derick Brinkerhof, Accountability and Health Systems: Toward Conceptual Clarity and Policy Relevance, 19(6) Health Policy and Planning 371–379; more generally, see Mark Bovens, Two Concepts of Accountability: Accountability as a Virtue and as a Mechanism 33(5) West Euro Politics (September 2010) 946–967.

General Comment 14, supra note 47 [43 (f)].

See also, Paul Hunt & Gunila Backman, Health Systems and the Right to the Highest Attainable Standard of Health, 10(1) Health & Human Rights (2008) 81–92.

General Comment 14, supra note 47 [51].

Mark Bovens, supra note 99, 946–967; Helen Potts, Participation and the Right to the Highest Attainable Standard of Health , University of Essex Human Rights Centre/Open Society Institute < http://repository.essex.ac.uk/9714/1/participation-right-highest-attainable-standard-health.pdf > accessed November 2015.

Constitutional Court of South Africa, Minister of Health v. Treatment Action Campaign (TAC), 2002(5) SA 712 (CC).

British American Tobacco Australasia Limited and Others v the Commonwealth of Australasia , Case S389/2411 < http://www.hcourt.gov.au/cases/case-s389/2011 > accessed November 2015. Peruvian Constitutional Tribunal, Jaime Barco Rodas, Unconstitutionality Claim of Article 3 of Law 28705, July 19, 2011, see the Global Health and Human Rights Law Database < http://www.globalhealthrights.org > accessed November 2015. See also Gostin, supra note 10, 235, 267.

Unfortunately, the Court of First Instance of The Hague rejected the case on 9 November 2015 (C/09/475711/HA ZA 14-1193 < http://uitspraken.rechtspraak.nl/inziendocument?id=ECLI:NL:RBDHA:2015:12746 > Accessed November 2015). For a brief discussion see this author’s blog post < https://ghlgblog.wordpress.com/2015/11/12/court-decision-in-the-case-concerning-the-close-ties-between-the-dutch-government-and-the-tobacco-industry-november-9th-2015-no-violation-of-article-53-fctc/ > accessed November 2015.

O’Neill Institute, Global Health and Human Rights Law Database, supra note 113.

HV Hogerzeil & ors, Is access to essential medicines as part of the fulfillment of the right to health enforceable through the courts? 22(368) Lancet (2006) 305.

See also Thérèse Murphey, Health and Human Rights (Hart, Oxford/Portland/Oregon, 2013); Toebes et al, supra note 13, 31–33 & 49–52.

Jennifer Prah Ruger & Derek Yach, The Global Role of the World Health Organization, II(2) Global Health Governance (Fall 2008/Spring 2009) 1. See also Gostin, supra note 10, 129.

General Comment 14, supra note 45 [66]; Jennifer Prah Ruger and Derek Yach, The Global Role of the World Health Organization, 2(2) Global Health Governance (2008–2009) 3.

General Comment 14, supra note 47 [66].

Gostin, supra note 10, 129.

Ruger & Yach, supra note 118, 1.

Inter alia , Gostin, supra note 10, 114–128.

World Health Organization Heal thyself, The Economist (December 13–19, 2014) 15–18.

Gostin, supra note 10, 123–124.

The Economist , supra note 124, 18.

Gostin & Taylor, supra note 2, 60; Aginam, supra note 23; Benjamin Mason Meier, The World Health Organization, the Evolution of Human Rights, and the Failure to Achieve Health for All, in, John Harrington & Maria Stuttaford (eds) Global Health and Human Rights (Routledge, Abingdon, 2010) 163–189. Benjamin Mason Meier, The Highest Attainable Standard: The World Health Organization, Global Health Governance, and the Contentious Politics of Human Rights (PhD thesis) (ProQuest Dissertations Publishing—Columbia University, Ann Arbor, 2009).

Jali < http://www.jalihealth.org/ > accessed November 2015. See also Lawrence O Gostin et al, A Framework Convention on Global Health, 91 Bulletin of the World Health Organization (2013) 790–793.

Lawrence O Gostin, Towards an International Health Systems Fund, The Lancet (2014) 1–3.

G Ooms & R Hammonds, Taking up Daniels’ Challenge: The case for Global Health Justice, 12 Health and Human Rights (2010) 3, 29–46, 12.

See also Aginam, supra note 25.

Jali < http://www.jalihealth.org/ > accessed November 2015; See also Global Health Governance, Special Issue: The Framework Convention on Global Health, January 28, 2016, available at < http://ilreports.blogspot.nl/2016/01/special-issue-framework-convention-on.html >.

Hans V Hogerzeil, Essential Medicines and Human Rights: What Can They Learn from Each Other?, 84 Bulletin of the World Health Organization (2006) 371–375; Amir Attaran et al, Health by Law: The Missed Opportunity to Use Laws for Public Health, 379 The Lancet (2012) 283–85; DC Jayasuriya, Regulation of pharmaceuticals in developing countries, (WHO, Geneva, 1985) < http://whqlibdoc.who.int/publications/1985/9241560894_eng.pdf > accessed November 2015.

See also the ELMA project at the University of Groningen < http://www.rug.nl/research/groningen-centre-for-law-and-governance/onderzoekscentra/ghlg/elma?lang=en > accessed December 2015.

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Prof Dr Brigit Toebes is Rosalind Franklin Fellow at the University of Groningen. The author is thankful to Dr André de Hoogh and Dr Panos Merkouris for comments to an earlier version of this article.

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Toebes, B. International health law: an emerging field of public international law. Indian Journal of International Law 55 , 299–328 (2015). https://doi.org/10.1007/s40901-016-0020-9

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Health Law Research

Secondary sources, primary sources, practice materials, organizations, interdisciplinary materials, getting help.

This guide provides an overview of health law research strategies. It will highlight some of the key secondary and primary resources in these areas. It will also provide current awareness sources. To learn more about performing legal research generally, please visit:

  • Legal Research Strategy by AJ Blechner Last Updated Sep 21, 2023 7490 views this year

Health law has become a distinct field in its own right. However, researchers may also wish to explore:  Bioethics, Health Care Policy & Reform, Medical Device Law & Industry, Medical Malpractice, Medicare/Medicaid, Pharmaceutical Law & Industry, and Public Health. For a brief summary of health law please visit:

  • Health Law: An Overview Cornell Legal Information Institute

Using Secondary Sources

Secondary sources are a great place to begin your research.  To learn more about secondary sources and how to use them, visit the following guide:

  • Secondary Sources: ALRs, Encyclopedias, Law Reviews, Restatements, & Treatises by Catherine Biondo Last Updated Apr 12, 2024 4767 views this year

Encyclopedias & American Law Reports

Legal encyclopedias contain brief, broad summaries of legal topics. They provide introductions to legal topics and explain relevant terms of art. State encyclopedias can also be found on Westlaw and Lexis.

  • American Jurisprudence 2d - Health - Westlaw
  • American Jurisprudence 2d - Health - Lexis
  • Corpus Juris Secundum - Health and Environment - Westlaw
  • Lawyers' Medical Cyclopedia of Personal Injuries and Allied Specialties

The American Law Reports contains in-depth articles on narrow topics of the law.  Use the following Indices to access the ALR.  Note: Lexis also has some ALR materials but Westlaw's are more complete.

  • Health Index Topic - ALR - Westlaw
  • Medical Care Index Topic - ALR - Westlaw

Health Law Treatises

There are many health law treatises within our collection.  Users can search in Hollis  for the most up-to-date legal treatises.

  • Hollis, the Harvard Library Catalog

Explore books by topic: Select Option Below Show All General Administration Bioethics & Biotechnology Mental Health Pandemic Response Policy Public Health

Books - General

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Books - Administration

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Books - Bioethics & Biotechnology

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Books - Mental Health

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Books - Pandemic Response

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Books - Policy

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Books - Public Health

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Legal and Medical Journals

In addition to Hollis, mentioned above, many databases can be used for secondary source research:

  • HeinOnline Health and Medicine
  • Lexis Healthcare Law Journals
  • Westlaw Health Law Journals

In addition to traditional law reviews and journals many advocacy organizations also publish:

  • American Health Law Association Seminar Papers For papers prior to 2009 visit the American Health Law Association Seminar Papers - Archive
  • American Journal of Law & Medicine by the American Society of Law and Medicine
  • Food and Drug Law Journal by the Food and Drug Law Institute
  • Internet Journal of Law, Healthcare and Ethics by Internet Scientific Publications
  • Issues in Law & Medicine by the National Legal Center for the Medically Dependent & Disabled
  • Journal of Law, Medicine, and Ethics by the American Society of Law, Medicine & Ethics
  • Journal of Legal Medicine by the American College of Legal Medicine

Using Primary Sources

Primary authority is  "authority that issues directly from a law-making body." Authority , Black's Law Dictionary (11th ed. 2019).  To learn more about primary sources and how to use them visit:

  • Primary Sources - Legal Research Strategy Guide
  • Health Law Statutes - Westlaw
  • Healthcare Law Statutes - Lexis
  • State Health Statutes - LII Table of state codes on health law, for general use only, not citation.

Statutes & Legislation

50 State Surveys are tools used to compare the law across multiple states.  To learn more about using and accessing 50 State Surveys see our guide on:

  • Comparing State Law - Prepare to Practice Guide

Comparing State Law

For 50 State Surveys on Health Law visit:

  • 50 State Surveys - Health - Westlaw
  • 50 State Surveys - COVID19 - Westlaw
  • 50 State Surveys Healthcare, Public Health, & Welfare Law - Lexis
  • State by State Guide to Managed Care Law

Legislative History

  • Federal & State Legislative History by Mindy Kent Last Updated Apr 18, 2024 365 views this year

This may help when considering the impact of Federal and State statutes related to health. Consider searching for earlier versions of the law, supporting testimony, and additional documentation. If available, consider consulting published legislative history.

  • A Legislative history of the Federal Food, Drug, and Cosmetic Act and its Amendments.
  • Legislative History of the Health Insurance Portability and Accountability Act of 1996
  • Legislative History of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003
  • Legislative History of the Social Security Amendments of 1965
  • Legislative History of the Patient Protection and Affordable Care Act
  • ProQuest Regulatory Insight Find regulations that have been promulgated as a result of the ACA.

If there is no existing legislative history, researchers may need to consult congressional materials directly.

Regulatory & Administrative Law

Regulations comprise a substantial portion of primary sources in health law research. Statutes may enable change in health policy (such as the Affordable Care Act) and create specific health programs (such as Medicare and Medicaid). Yet, the way those policies and programs are administered relies primarily on regulation.

If you are unfamiliar with how to conduct regulatory research, please visit:

  • Administrative Law Research by AJ Blechner Last Updated Apr 12, 2024 587 views this year

The regulatory process can be complex, especially in the field of health care. Multiple agencies can be involved in promulgating regulations, further complicating the process. This visual overview can be helpful:

health law research paper

It may be easiest to start with a regulation by number or agency by name. Secondary sources such as books, scholarly articles, or advocacy communications can help you get started.

Government agencies websites provide information about proposed regulations and track them through the regulatory process.

  • Federalregister.gov Contains federal agency documents, including proposed rules, final rules, public notices, and Presidential actions. This unofficial format provides the same material printed in the official Federal Register. It also contains related material from the Code of Federal Regulations and the US Code.
  • Regulations.gov Allows users to search regulatory materials, submit comments, and sign up for email alerts. Some agencies require that comments be submitted through their own individual platforms. However, regulations.gov serves as a clearinghouse for the majority of publicly available public comment material.
  • Reginfo.gov Produced by the Office of Management and Budget (OMB) and the General Services Administration (GSA). OMB's Office of Information and Regulatory Affairs (OIRA) reviews Federal regulations and information collections. The site provides information about regulations under development to enable public participation.

Administrative Materials are also accessible on both Westlaw and Lexis:

  • Health Law Regulations - Westlaw
  • Health Law Administrative Decisions & Guidance - Westlaw
  • Healthcare Law Administrative Codes & Regulations - Lexis
  • Healthcare Law Administrative Materials - Lexis

Agency websites also contain regulations and resources that can aid in conducting research:

  • Health and Human Services Regulations
  • Food & Drug Administration Regulations
  • Centers for Medicare & Medicaid Services Regulations
  • Federal & State Health Law Cases - Westlaw
  • Federal & State Health Law Cases - Lexis

Some agencies can also decide cases related to particular regulations. These agency decisions may not be included in general case law databases. Decisions can often be accessed through agency websites:

  • HHS Compliance - Advisory Opinions
  • CMS Medicare Advantage/Prescription Drug Plan Decisions
  • HHS Departmental Appeals Board Decisions
  • HHS Enforcement Actions
  • FDA Enforcement Reports
  • FDA Warning Letters

Using Practice Materials

Practitioners often write the most helpful resources in the field of health law. Although they have similarities to treatises, they are directed at lawyers in practice. They may contain checklists and forms not available in a traditional treatise.

Practice Centers

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  • Healthcare Law Practice Center - Lexis

Practitioner Materials

Handbooks and guides are helpful when working on health law issues as a new practitioner.

  • Health Law Handbook
  • Health Care Compliance Guide - Bloomberg
  • Health Law Practice Guide
  • Health Care Law: A Practical Guide

Current Awareness Sources

Advocacy resources.

  • POLITICO Pro PoliticoPro provides subject-based issue and policy tracking tools in multiple areas including Health Care. It prepares issue pages for major policy areas. Features include: news, calendar function, whiteboard, charts, graphs, and glossaries, all in well-organized practice centers. PoliticoPro content relies on policy experts in the field, writing in real time. The site also stores all primary source documents in a "document drawer" for easy access.
  • Legistorm The In the News section curates news from Capitol Hill. StormFeed provides updates from press releases, twitter accounts from legislators, and relevant trending hashtags. For regular alerts request a personal account, contact [email protected].
  • Vitallaw The Health Care library includes several Daily Documents and Newsletters. Researchers can also find CMS manuals and guidance, and State Health Care information.

News Sources

Keeping up-to-date with new developments in the field of health law will enhance research projects. Recent headlines in the field may also inspire researchers still looking for a paper topic. Use these links to find news sources related to health law:

  • Kaiser Health News A nonprofit news service committed to in-depth coverage of health care policy and politics (not affiliated with Kaiser Permanente).
  • Health Affairs A leading peer-reviewed journal of health policy thought and research. Aims to offer a nonpartisan forum to promote analysis and discussion.
  • Medpac An independent congressional agency advising the U.S. Congress on issues affecting the Medicare program.
  • Health Law & Business News - Bloomberg
  • Health Law Daily - Westlaw Daily updates on current health law developments including the areas of food safety and Medicaid.

Legal Blogs have become an increasingly rich source of information and legal news.  Below are two indices to health law blogs:

  • ABA Journal Health Law Blogs Index
  • Justia Healthcare Law Blogs

Non Profits and NGOs

  • National Agencies and Organizations from Pace Health Law Research Guide

The following organizations may be particularly useful to researchers:

  • Center for Medicare Advocacy Nonprofit, nonpartisan law organization providing education, advocacy, and legal assistance to help people obtain Medicare. In addition to the newsroom, you can sign up for alerts via email.
  • Families USA A consumer advocacy group that focuses on Health Care, with a robust newsroom. You can access insights, reports, raw data, and more under their resources tab.

Kaiser Family Foundation

  • Kaiser Family Foundation A non-profit organization focusing on national health issues. They provide policy analysis, journalism, and communication for the general public.

Kaiser Health News includes a morning briefing and updates via email or RSS feed:

Community Catalyst

  • Community Catalyst Non-profit dedicated to consumer health advocacy, working in 40 states across the country.
  • Dual Agenda Newsletter Includes state highlights on health care reform. Their  ACA Implementation Fund  partners with state-based advocacy groups on issues related to the implementation of health care reform. They focus on the state level, and explore the impact of potential repeal.
  • Health Policy Hub Blog Allows for email subscription.

The latest posts from their feed are included below:

Health & Medical Field Resources

Health law is an interdisciplinary area. You may benefit from accessing health and biomedical resources.  

For unfamiliar terms and acronyms consult the following:

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There are several health and medical databases that may be helpful in your research:

  • Harvard Medicine & Public Health Databases
  • PubMed For how to use please visit the Pubmed Research Guide
  • Web of Science

Additional Resources

Health law also touches on many different research areas.  These additional research guides contain important content related to health law:

  • Administrative Law Research by AJ Blechner Last Updated Apr 12, 2024 588 views this year
  • Health Policy by James Adams Last Updated May 25, 2023 144 views this year
  • Law and Public Policy by Mindy Kent Last Updated Apr 12, 2024 399 views this year
  • Research Guide on International Health Law GlobaLex Guide from Professor Chenglin Liu, St. Mary's University School of Law

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  • v.58(Suppl 2); 2016 Dec

Mental health and the law: An overview and need to develop and strengthen the discipline of forensic psychiatry in India

Pratima murthy.

Department of Psychiatry, National Institute of Mental Health and Neuro Sciences, Bengaluru, Karnataka, India

B. C. Malathesh

C. naveen kumar, suresh bada math.

Human rights and mental health care of vulnerable population need supportive legislations and policies. Both “hard” and “soft” laws relevant to mental health care have been devised internationally and locally. Amendments in laws and the formulation of new laws are often required and have been seen to occur in the area of mental health care in India. So far, reform in mental health care has largely been reactive, but newer legislations and policies carry the hope of proactive reform. The lack of trained human resources is one of the biggest problems in effective mental health care delivery in India. While postgraduate psychiatric guidelines recommend a 2-week training in forensic psychiatry, this is insufficient to develop the necessary competence in the area. There is, thus, a need to develop subspecialty of forensic psychiatry. Forensic psychiatric services also need to be developed, properly structured, and supported. There is a need to set up one or more centers of excellence in forensic psychiatry in India.

INTRODUCTION

People with mental disorders are vulnerable to abuse and violation of their basic rights.[ 1 ] Such abuse or violation may occur from diverse elements in society including institutions, family members, caregivers, professionals, friends, unrelated members of the community, and law enforcing agencies. This sets an imperative for a protective mechanism to ensure appropriate, adequate, timely, and humane health care services.[ 2 ] Such protective mechanisms include legislative provisions and policies to ensure that the rights of this vulnerable group are protected. In the undeniable context that every society needs laws in various areas to maintain the well-being of its people, mental health care is one such important area that requires appropriate legislation.

In this paper, we first provide a brief overview of the “hard” and “soft” laws that have been influential in mental health policy and care, both internationally and nationally. We then provide a brief glimpse of some of the efforts at the national level to address issues of human rights of persons with mental illness. This is followed by a summary of the broad areas that forensic psychiatry embraces. We then examine the status of forensic psychiatry in India and finally discuss the need to develop comprehensive forensic services and training in India.

“HARD” AND “SOFT” LAWS GOVERNING OR INFLUENCING MENTAL HEALTH CARE

“Hard” laws refer to laws that are binding and enforceable internationally or domestically. “Soft” laws, on the other hand, are not binding. However, soft laws if well constructed and reflect a broad consensus can become a model for future legislation.[ 3 ] In the last 70 years, there have been a number of international conventions, declarations, covenants, etc., that have reference to mental illnesses/mental health of an individual. Table 1 gives details of legally binding international instruments relevant to mental health. The Universal Declaration of Human Rights (UDHRs)[ 4 ] was adopted in 1948. Article 1 of the UDHRs, adopted by the United Nations in 1948, provides that “all people are free and equal in rights and dignity” – “establishing that people with mental disabilities are protected by human rights law by virtue of their basic humanity”

International legally binding instruments

An external file that holds a picture, illustration, etc.
Object name is IJPsy-58-181-g001.jpg

India is a signatory to many of these international declarations and thus has an obligation to align her laws to suit these.

In India, some of the hard laws pertaining to mental health include The Mental Health Act, 1987; The Protection of Human Rights Act, 1993; Persons with Disability Act, 1995; The National Trust Act, 1999; Protection of Women from Domestic Violence Act, 2005; Protection of Children from Sexual Offences Act, 2012, and related legislations. A prominent statutory legislation regulating narcotics is the Narcotic Drugs and Psychotropic Substances (NDPS) Act 1985.

Strictly speaking, “soft” laws are not really laws at all; they are rules or policies that are quasi-legal and not binding. They are defined as having “hortatory” obligations, i.e., statements in the nature of promises. It is argued that in the course of time, these may become binding. Some examples include the National Mental Health Policy 2014 and the National Mental Health Programme (with its operational arm, the District Mental Health Programme).[ 12 ] Another example is the National Programme on Noncommunicable Diseases.[ 13 ]

AMENDMENTS AND NEW LAWS

An amendment is a formal or official change made to a law. Such amendments may occur to improve the law, correct errors, improve equity, make the provisions more stringent, or to make sure that the law is compliant with international conventions. The NDPS Act was thus amended thrice, the last time in 2014. With respect to the Mental Health Care Act 1987, several shortcomings were recognized in the act; state rules were not formulated for decades after its enactment and the need for compliance with the UNCRPD led to several debates about whether to amend the existing law or enact a new one.[ 14 ] At present, the Mental Health Care Bill 2016 which was approved by the Rajya Sabha awaits ratification in the Lok Sabha. Similarly, the Rights of Persons with Disability Bill, which is intended to replace the Act of 1995, was introduced in 2014 and awaits ratification.

MENTAL HEALTH CARE REFORM IN INDIA

Although the National Mental Health Programme in the country has been existent since 1982 and was re-strategized in 1996, it would be appropriate to state that policy and programming in mental health so far has been more reactive than proactive. Tragedies like Erwadi and a series of public interest litigations (PILs) that have been filed before the Supreme Court of India have been major drivers of change.[ 15 ] Some of the PILs have not only focused on institutional treatments but also focused on economic, social, and cultural rights of persons with mental illness. A series of reports from the National Human Rights Commission[ 16 , 17 ] highlights the gross deficiencies that existed in institutional care of persons with mental illness and also demonstrated the positive changes that could be brought about with persistent monitoring, collaboration, and proactive intervention – structural facilities and living conditions improved, budgets improved, voluntary admissions became more frequent than court admissions, there was greater community participation, and the need for rehabilitation of persons with mental illness received greater focus. However, these reports have also highlighted the negative aspects in terms of inadequate human resources and poor psychosocial interventions, among others.

Meantime, the need to provide the least restrictive care for persons with mental illness and by extension to develop adequate community care facilities for persons with mental illness has been the driving philosophy of the National Mental Health Policy. However, a recent report compiling state and union territory reports of the status of mental health care reveals extremely low coverage of primary mental health care in the country.[ 18 ] The recently published Mental Health Survey Report[ 19 ] carried out in 12 states of the country estimates the prevalence of mental disorders at 10.6%, and the mental health care gap that has been calculated in these states as varying between 70.4% and 86.3%. In reality, given the huge inequity of mental health care resources across different states, and local ecologies that may aggravate mental distress, the mental health care treatment gap may be much higher. Mental health care, like other health care, requires human resources, facilities, and protected budgets. Whether the new Act will ensure equitable care to persons with mental illness remains to be seen. However, one stark truth is that there needs to be a concerted drive to improve human resources in mental health care, and that will be the biggest challenge in the decades ahead.[ 20 ] While there is a need to train all health providers in issues related to mental health, it is also important to develop specialists in different aspects of mental health care. In addition, strengthening undergraduate psychiatry training as well as postgraduate training in psychiatry is of primary importance.

POSTGRADUATE TRAINING IN PSYCHIATRY

In the postgraduate training guidelines formulated by the Indian Psychiatric Society,[ 21 ] a 2-week posting in forensic psychiatry is recommended. Unfortunately, there are few centers in the country that have any specialized forensic psychiatry service. Thus, many postgraduate students from different institutions throughout the country come to centers such as the National Institute of Mental Health and Neurosciences (NIMHANS) which have relatively more structured forensic psychiatry services. However, it is important to emphasize that throughout postgraduate psychiatry, whether in adult psychiatry, child psychiatry, addiction treatment services, emergency services, etc., it is very important for the postgraduate trainee to be aware of the medicolegal aspects of psychiatric practice. With this caveat, we further discuss more specialized training in forensic psychiatry and the need to develop forensic psychiatry as a specialized discipline within psychiatry. One such area of specialization is in forensic psychiatry.

THE EXPANDING HORIZON OF FORENSIC PSYCHIATRY

Over time, the narrow notion that forensic psychiatry mainly concerns itself with criminal responsibility and fitness to stand trial has long been dissipated, and it is clear that several civil aspects of mental health as well as issues related to treatment of mental illness come under the domain of forensic psychiatry. The interface between mental health and law is vast as shown in Figure 1 .

An external file that holds a picture, illustration, etc.
Object name is IJPsy-58-181-g002.jpg

Various facets of mental illness and law

FORENSIC PSYCHIATRY AS A SUBSPECIALTY OF PSYCHIATRY

Pollack defined Forensic Psychiatry as a “broad general field in which psychiatric theories, concepts, principles and practices are applied to any and all legal issues.” The American Academy of Psychiatry and the Law endorses the definition of Forensic Psychiatry adopted by the American Board of Forensic Psychiatry. “Forensic Psychiatry is a subspecialty of psychiatry in which scientific and clinical expertise is applied to legal issues in legal contexts embracing civil, criminal, and correctional or legislative matters; forensic psychiatry should be practiced in accordance with guidelines and ethical principles enunciated by the profession of psychiatry.”[ 22 ]

The origin of Forensic Psychiatry in India dates back to the drafting of the Indian Penal Code (IPC) by Thomas Babington Macaulay during the mid-19 th century. During the same time, the Mc Naughten's rules were incorporated into the IPC, Section 84, and are the basis for the insanity defense. This has not changed till date. However, there have been many landmark judgments with regard to Section 84, IPC.[ 23 ]

Regarding civil responsibilities, mental illness is relevant across diverse areas. For example, issues such as marriage, divorce, testamentary capacity, contract, voting, consent, fitness for holding and continuing jobs, succession of property rights, guardianship, and social welfare benefits have reference to mental health and illness either directly or indirectly. The new provisions in the Mental Healthcare Bill, 2016, and the Rights of Persons with Disabilities are expected to bring a paradigm shift in the conceptualization of care of those with psychiatric disorders.

CURRENT STATUS OF TRAINING IN FORENSIC PSYCHIATRY IN INDIA

In India, there is very little infrastructure and organized training in forensic psychiatry. Most psychiatric units do not have a dedicated forensic psychiatry ward/unit. Most forensic evaluations are done by the treating psychiatrist who has had little or no formal training in forensic psychiatry. Thus, in many cases, decisions occur by trial and error or in good faith, rather than being based in skill and competence.

There are no specialized training programs in forensic psychiatry in India. Countries like UK offer a 3-year advanced structured training program in forensic psychiatry, which can be taken after 3 years of core psychiatry training. There are a few centers in the country where training in Forensic Psychology has been initiated.

The programs in developing competencies in forensic psychiatry need to concentrate on multiple areas and contexts. These are summarized in Table 2 .

Skills and competencies required in forensic psychiatry training

An external file that holds a picture, illustration, etc.
Object name is IJPsy-58-181-g003.jpg

A BRIEF NOTE ON RESEARCH IN FORENSIC PSYCHIATRY

Indian literature on forensic issues such as negligence, informed consent, confidentiality, certification, seclusion, suicide, homicide, and the complication of various therapies is very negligible.[ 24 ] In the last 50 years, there are hardly 50 articles published on forensic psychiatry in the Indian Journal of Psychiatry. There articles can be broadly arranged under the following three headings: (a) criminology related psychiatric aspects, (b) mental health legislation related, and (c) others. More recently, a survey conducted by NIMHANS in the Bengaluru Central Prison[ 25 ] showed that 79.6% prisoners had either mental illness or substance use disorder. After excluding substance use, 27.6% had diagnosable mental disorder. There were high rates of tobacco use within the prison and in fact a 4-time increase in tobacco consumption after getting into prison. On conducting a random urine drug screen, 61.3% of those screened anonymously tested positive for one or the other drug. About 12.7% has life time history of major depressive disorder and 9.1% had current episode of major depression. Nearly 2.2% of prisoners had psychosis with substantial of them being substance use related psychosis. Another study done by Chadda and Amarjeeth in Tihar jail of Delhi in 1998[ 26 ] revealed that prevalence of psychiatric illness in prisoners was 3.4%. They also found that depression and schizophrenia were the most common diagnosis in patients involved in major crimes and majority of patients with schizophrenia were implicated in cases of homicide. These studies highlight the need for mental health care in prisons.[ 25 ]

ETHICAL ISSUES IN RESEARCH IN FORENSIC PSYCHIATRY

Soundness of mind is generally assumed in other branches of medicine, but in psychiatric research, there are often individuals who lack full judgment capacity or decision-making capacity.[ 25 ] The most common ethical dilemma in forensic psychiatry is between the two principles of (a) beneficence or promotion of welfare and (b) respect for justice.[ 27 ] The forensic psychiatrist often has to make a choice between well-being of the patient and well-being of the society as a whole. In India, the psychiatrist practicing forensic psychiatry has the dual role of both carrying out forensic assessments as well as providing medical treatment. In settings with well-established forensic services, one way of overcoming this dilemma has been to have forensic psychiatrists carrying out mental assessments of mentally ill offenders on behalf of the legal system, and treatment provision by a different set of treating professionals.

The ultimate aim of the forensic psychiatrist should be revelation of truth as part of pursuit of justice without affecting privacy and autonomy of the patient.[ 28 ] As per the American Academy of Psychiatry and Law, forensic evaluation should never be conducted for either prosecution or government until the evaluee has had access to legal counsel.[ 29 ]

MENTALLY ILL OFFENDERS

Although most prisons do have facilities to address basic physical health issues, prison-based mental health services are in a very rudimentary state in India. Many of the prisons have facilities of a visiting psychiatrist but not a full-time psychiatrist. Routine assessments for mental disorders or substance use are rarely carried out and a psychiatrist is usually only called upon only if there any signs of mental illness in an undertrial prisoner or convict. Another issue of serious concern is that there is no practice of routine mental status assessment in prisoners condemned to death.

After a landmark observation in the 1980s of “noncriminal lunatics” languishing in jails in very poor conditions, such a practice was considered unconstitutional and a violation of human rights.[ 30 ] These findings indicate urgent need for the diversion of prisoners with mental illness to mental health care settings.[ 26 ] However, mental health care settings are ill equipped to take on this responsibility at present.

The mental condition of the offender is specifically of concern to the judicial system in two scenarios, one to ascertain mental state at the time of committing the crime and the other to assess fitness to stand trial. Such patients may be evaluated as outpatient or where facilities exist, as inpatients. Security is a prime concern when prison referrals occur as such patients are under the dual custody of the superintendents of the jail and the mental health facility. Apart from security, there are several other challenges in the inpatient assessment and care of undertrial and convict prisoners referred to a psychiatric facility. An important issue is the lack of background information about the patient's history, behavior, and serial mental state examinations before referral. The second is the lack of clear guidelines about the involvement and engagement of the family and legal counsel in patient care and decision-making. Determining mental state at the time of committing the offense is also challenging as the individual is often referred to psychiatric services long after incarceration and commencement of the trial. The lack of access to objective forensic investigations makes it difficult to identify offenders feigning insanity.

Inpatient forensic services require appropriate infrastructure, well-trained human resources, adequate security, facilities for close behavioral observation and monitoring, specialized investigations, and well-developed and structured assessments and procedures. This can be implemented only by creating dedicated infrastructure and human resources for forensic psychiatry.

FUTURE DIRECTIONS

Forensic psychiatry remains a neglected area in India and other countries in South-East Asia. This is unlike many of the developed settings where it has become an established subspecialty with a focus on clinical services, training, and research. Academic centers need to actively engage in developing this area. They need to consider the fast-growing need of developing this specialty, recognize the vast scope of the field, and device curricula that cater to the diverse needs of the country. Dedicated clinical services need to be started for this vulnerable patient population. Apart from the dedicated fellowships and super-specialties, training courses catering to the different mental health disciplines (psychiatry, clinical psychology, psychiatric social work, and psychiatric nursing) students in other branches of medicine and law also need to be trained in the forensic aspects of mental health care. In addition, various other stakeholders who need regular sensitization and training in issues relating to mental health include law enforcement agencies, judiciary, advocates, and women and child welfare departments, commissions related to the mental health (including the Human Rights Commissions, Women's Commissions, Child Welfare Commissions, etc.). Support for focused research in many areas of overlap between mental health and the law is also critical. It is important for government to take initiatives to establish centers of excellence in forensic psychiatry.

One such effort has begun at the NIMHANS, Bengaluru, where such a center has been conceptualized, and a postdoctoral fellowship in forensic psychiatry has been initiated in 2016. The proposed center, called the Centre for Human Rights, Ethics, Law and Mental Health, has the objectives of (a) enhancing trained human resources in the areas of forensic psychiatry, law and human rights of persons with mental illness, (b) establishing and providing the highest standards in diagnostic and investigative approaches in forensic psychiatry, (c) developing a state of art clinical and resource facility in forensic psychiatry, (d) facilitating the development of quality forensic services in different parts of the country, (e) contributing to capacity building by providing training in forensic psychiatry for mental health, medical, police personnel, human rights activists and law professionals, (f) developing and strengthening inter-disciplinary, inter-institutional and international collaboration to foster research in forensic psychiatry, (g) developing guidelines, standard operating procedures, providing expert opinion in the area of forensic psychiatry, (h) conducting research with regard to mental health laws, medico-legal psychiatry, forensic psychiatry and child forensic psychiatry, and to (i) guiding national policy and develop national guidelines for developing quality forensic psychiatric services in India.

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Anti-semitic attitudes of the mass public: estimates and explanations based on a survey of the moscow oblast.

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JAMES L. GIBSON, RAYMOND M. DUCH, ANTI-SEMITIC ATTITUDES OF THE MASS PUBLIC: ESTIMATES AND EXPLANATIONS BASED ON A SURVEY OF THE MOSCOW OBLAST, Public Opinion Quarterly , Volume 56, Issue 1, SPRING 1992, Pages 1–28, https://doi.org/10.1086/269293

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In this article we examine anti-Semitism as expressed by a sample of residents of the Moscow Oblast (Soviet Union). Based on a survey conducted in 1920, we begin by describing anti-Jewish prejudice and support for official discrimination against Jews. We discover a surprisingly low level of expressed anti-Semitism among these Soviet respondents and virtually no support for state policies that discriminate against Jews. At the same time, many of the conventional hypotheses predicting anti-Semitism are supported in the Soviet case. Anti-Semitism is concentrated among those with lower levels of education, those whose personal financial condition is deteriorating, and those who oppose further democratization of the Soviet Union. We do not take these findings as evidence that anti-Semitism is a trivial problem in the Soviet Union but, rather, suggest that efforts to combat anti-Jewish movements would likely receive considerable support from ordinary Soviet people.

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Land use changes in the environs of Moscow

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