On September 30–October 2, 2005, a group of individuals drawn from civil society organizations, governments, international agencies, and academic institutions came together in Montréal, Québec, Canada, for an international workshop entitled “Human Rights and Access to Essential Medicines: The Way Forward.” At the conclusion of the workshop, we drafted the “Montréal Statement on the Human Right to Essential Medicines.” This “Statement” is reprinted at the end of this comment, which offers some background on the problem addressed at the workshop.

More than 25 years into the HIV epidemic, in excess of 2 million new infections continue to occur each year. HIV prevention research is crucial for groups at heightened risk for HIV, but the design and conduct of HIV prevention research with vulnerable populations worldwide raises considerable ethical challenges. The HIV Prevention Trials Network (HPTN) is a global collaborative network that conducts clinical and behavioural studies on non-vaccine interventions to reduce the transmission of HIV. In 2003, the HPTN developed ethical (...) guidance to enhance the responsible conduct of its research activities and as a distinctive contribution to global research ethics. In what follows, the developments that motivated the drafting of a revised ethics document in 2009 are described, including the process by which that revision took place and some of the key differences between the HPTN ethics guidance and other relevant guidelines in the field. (shrink)

Domestic litigation has become a principal strategy for realizing international treaty obligations for the human right to health, providing causes of action for the public’s health and empowering individuals to raise human rights claims for HIV prevention, treatment, and care. In the past 15 years, advocates have laid the groundwork on which a rapidly expanding enforcement paradigm has arisen at the intersection of human rights litigation and HIV/AIDS policy. As this enforcement develops across multiple countries, human rights are translated from (...) principle to practice in the global response to HIV/AIDS, transforming aspirational declarations into justiciable obligations and implementing human rights through national policies and programs. (shrink)

Domestic litigation has become a principal strategy for realizing international treaty obligations for the human right to health, providing causes of action for the public’s health and empowering individuals to raise human rights claims for HIV prevention, treatment, and care. In the past 15 years, advocates have laid the groundwork on which a rapidly expanding enforcement paradigm has arisen at the intersection of human rights litigation and HIV/AIDS policy. As this enforcement develops across multiple countries, human rights are translated from (...) principle to practice in the global response to HIV/AIDS, transforming aspirational declarations into justiciable obligations and implementing human rights through national policies and programs. (shrink)

The right to health was codified in Article 12 of the International Covenant on Economic, Social and Cultural Rights as an individual right, focusing on individual health services at the expense of public health systems. This article assesses the ways in which the individual human right to health has evolved to meet collective threats to the public's health. Despite its repeated expansions, the individual right to health remains normatively incapable of addressing the injurious societal ramifcations of economic globalization, advancing individual (...) rights to alleviate collective inequalities in underlying determinants of health. By examining modern changes to underlying determinants of health, this article concludes that responding to globalized health threats necessitates a collective right to public health. (shrink)

In confronting the insalubrious ramifications of globalization, human rights scholars and activists have argued for greater national and international responsibility pursuant to the human right to health. Codified seminally in Article 12 of the International Covenant on Economic, Social and Cultural Rights, the right to health proclaims that states bear an obligation to realize the “highest attainable standard” of health for all. However, in pressing for the highest attainable standard for each individual, the right to health has been ineffective in (...) compelling states to address burgeoning inequalities in underlying determinants of health, focusing on individual medical treatments at the expense of public health systems. This article contends that the paradigm of individual health, focused on a right to individual medical care, is incapable of responding to health inequities in a globalized world and thereby hampers efforts to operationalize health rights through public health systems. While the right to health has evolved in international discourse over time, this evolution of the individual right to health cannot address the harmful societal ramifications of economic globalization. Rather than relying solely upon an individual right to medical care, envisioning a collective right to public health – a right applied at the societal level to address underlying determinants of health – would alleviate many of the injurious health inequities of globalization. (shrink)

There is more to modern health than new scientific discoveries, the development of new technologies, or emerging or re‐emerging diseases. World events and experiences, such as the AIDS epidemic and the humanitarian emergencies in Bosnia and Rwanda, have made this evident by creating new relationships among medicine, public health, ethics, and human rights. Each domain has seeped into the other, making allies of public health and human rights, pressing the need for an ethics of public health, and revealing the rights‐related (...) responsibilities of physicians and other health care workers. (shrink)

Despite growing advances in medical technologies, health status inequalities continue to increase across the globe. Developing countries have been faced with declining expenditures in health and social services, increasing burdens posed by both communicable and non-communicable diseases, and economic systems poorly geared to fostering sustainable development for the poorest and most marginalized. Under such circumstances, the challenges facing health practitioners in countries in transition are complex and diverse, and require the balancing of many conflicting imperatives. This is particularly so in (...) relation to the development of public health policy, where equity, redress of past inequalities, and the god of social justice may seemingly be pitted against macroeconomic adjustments required for national economic development in an increasingly globalized economic order.For example, pressures to deregulate as part of a market-oriented development philosophy will increase the risks from occupational hazards in populations desperate for paid employment. (shrink)

Despite growing advances in medical technologies, health status inequalities continue to increase across the globe. Developing countries have been faced with declining expenditures in health and social services, increasing burdens posed by both communicable and non-communicable diseases, and economic systems poorly geared to fostering sustainable development for the poorest and most marginalized. Under such circumstances, the challenges facing health practitioners in countries in transition are complex and diverse, and require the balancing of many conflicting imperatives. This is particularly so in (...) relation to the development of public health policy, where equity, redress of past inequalities, and the god of social justice may seemingly be pitted against macroeconomic adjustments required for national economic development in an increasingly globalized economic order.For example, pressures to deregulate as part of a market-oriented development philosophy will increase the risks from occupational hazards in populations desperate for paid employment. (shrink)

The massive growth in global health research in past decades has posed many challenges for its effective ethical oversight, not least of which is how best to provide effective protection of research participants. The extent of the HIV epidemic in sub-Saharan Africa in particular makes research into prevention technologies for HIV, including HIV vaccine research, a global priority. However, the need for vaccine research must be considered in conjunction with the individual's right to informed consent, which is based on the (...) principle of respect for autonomy. One of the primary human rights violations likely to occur in the context of HIV vaccine research is that potential research participants may not fully understand what participation in research studies entails. People who elect to enrol in HIV vaccine trials are required to understand both the potential negative effects of participation (eg, discrimination) as well as complex scientific concepts such as randomisation and prophylaxis in order to be ethically enrolled. In this study, two vignettes are presented to illustrate two core issues in conducting phase III HIV vaccine trials in low-income countries—namely, (1) from the perspective of participants, the extent to which understanding is a prerequisite for consenting to participate in a trial, and (2) from the perspective of trial investigators, whether it is appropriate to persuade eligible people to enrol in a trial, even though their initial reaction is to decline to participate. These vignettes are used to analyse these issues through the prisms of research ethics and human rights in order to identify helpful synergies. It is argued that the human rights perspective provides a helpful lens on ethical issues. (shrink)

In 2010, randomized controlled trials (RCTs) of two different biomedical strategies to prevent HIV infection had positive findings. However, despite ongoing very high levels of HIV infection in some countries and population groups, it has been made clear by regulatory authorities that the evidence remains insufficient to support either product being made available outside of research contexts in the developing world for at least two years. In addition, prevention trials in endemic areas will continue to test new interventions against placebo. (...) But the judgments of evidentiary standards are never value-neutral. Using the recent trials and their contexts as case studies, we examine the basis for these decisions, which will potentially delay access to scientific innovation to the people who are most urgently in need of it. (shrink)

The dominant language of politics in the United States has been political individualism, with minimal restrictions on property and personal, voluntary conduct. But there are second languages of community that stress cooperation and group action. These second languages include the constitutional tradition for public health. Public health offers a community justification for paternalistic measures that, for example, discourage smoking or require seatbelts.

One would be hard pressed to find a more controversial or nebulous human right than the right to health - a right that stems primarily, although not exclusively, from Article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR). While activists, non-governmental organizations, and scholars have made significant progress in promoting a human rights approach to health and the field of health and human rights more generally, the question of a philosophical and conceptual foundation - a theory (...) - for the right to health has fallen through the cracks that emerge from an interdisciplinary intersection of medical ethics, international relations, international human rights law, health policy, health law, and public health law. This Article offers a philosophical justification for a right to health. As such it makes a case for the right to health as a meaningful and operational right and discusses the degree to which this right is necessarily justifiable and enforceable as prescribed in international law. The theoretical framework proposed in this Article builds on and integrates Aristotle's political theory, the capability approach, and a social choice paradigm known as incompletely theorized agreements. This Article draws on these perspectives to develop a theory of a right to health and to explicate societal obligations, both state and non-state, for progressive realization of this right. Finally, this Article argues that sustaining the effort to realize a right to health requires individual and societal commitments to what I call public moral norms. In other words, this Article argues for treating the right to health as an ethical demand for equity in health. This ethical demand will likely involve legal instruments for enforcement, but more likely will require individuals, states, and non-state actors to internalize public ethical norms to enhance implementation and compliance with a right to health in international human rights policy and law. (shrink)