This article examines two spheres of global governance in which the World Health Organization (WHO) has sought to exercise international leadership — combating “counterfeit” medicines and illicit trade in tobacco products. Medicines and tobacco products lie at polar opposite ends of the health spectrum, and are regulated for vastly different reasons and through different tools and approaches. Nevertheless, attempts to govern counterfeit trade in each of these products raise a host of somewhat similar challenges, involving normative and operational conflicts that (...) cut across the crowded intersection of health protection and promotion, intellectual property protection, and activity to combat transnational organized crime. As negotiations of an illicit trade protocol to the WHO Framework Convention on Tobacco Control enter their final stages, lessons learned from counterfeit medicines governance need to be applied to ensure that the most appropriate governance arrangements are adopted. (shrink)

In her opening address to the 2011 session of the World Health Organization's governing body, the World Health Assembly, WHO's Director-General, Dr. Margaret Chan, noted that WHO's job was much more straightforward when it was dealing mainly with germs, hygiene, medicines, vaccines and sister sectors, like water supply and sanitation. Today, international public health governance is much more complex. It is not only about forging agreement around shared health problems, but also being concerned with health as an outcome of global (...) policies in areas such as trade, intellectual property, and human rights and, nationally, as an outcome of work in other sectors such as education, agriculture and the environment. Global health governance is increasingly fragmented, and WHO is not the only health game in town. (shrink)

Industry control over the production and distribution of pharmaceutical safety and efficacy data has become a serious public health and health care funding concern. Various recent scandals, several involving the use of flawed representations of scientific data in the most influential medical journals, highlight the urgency of enhancing pharmaceutical knowledge governance. This paper analyzes why this is a human rights concern and what difference a human rights analysis can make. The paper first identifies the challenges associated with the current knowledge (...) deficit. It then discusses, based on an analysis of case law, how various human rights associated interests can be invoked to support the claim that states have an obligation to actively contribute to independent knowledge governance, for example through ensuring clinical trials transparency. The paper further discusses a conceptual use of human rights, as a methodology which requires a comprehensive analysis of the different interwoven historical, economic, cultural, and social factors that contribute to the problem. Such an analysis reveals that historically grown drug regulations have, in fact, contributed directly to industry control over pharmaceutical knowledge production. This type of finding should inform needed reforms of drug regulation. The paper ends with a recommendation for a comprehensive global response to the problem of pharmaceutical knowledge governance. (shrink)

In recent years, the development process of pharmaceuticals, medical devices, and related products and the overall market of these products have become increasingly global. This paper discusses the need for better governance of one aspect of this market: the production, distribution, and use of pharmaceutical knowledge. Various controversies, some of which will be described in this paper, highlight how industry control over pharmaceutical data production has resulted in very serious threats to public health. Different practices and regulatory fields that affect (...) what I will refer to in this paper as “pharmaceutical knowledge production” are all too often artificially separated and dealt with in isolation, which seriously affects the quality of the available information on the safety and effectiveness of products. I will examine here how a human rights-based approach should inspire us to look more carefully not only at the significant human rights-related interests that are at stake, but also at the relations between the different interwoven regulatory, cultural, and social factors and how these play out at the various stages of knowledge production. (shrink)

In coming decades, enhanced global health governance will be crucial to achieving international health and development objectives in the face of a number of challenges; this article focuses on one of them. Climate change, which is now widely recognized as the defining challenge of the 21st century, will make the work of ensuring the conditions in which people can be healthy more difficult in a myriad of ways. Scientists from both the health and climate communities have been highlighting the significant (...) interaction between climate and health for decades and have made significant strides in integrating health and environmental research. Those of us in the law and policy community have been a bit slow to catch up, and have only just begun to call for better integration of our responses to health and environmental concerns. Environmental health specialists at the World Health Organization have recently pointed to a mandate for better integration of health and environmental concerns within the United Nations system. The Millennium Development Goals interweave health, environmental, and development concerns. (shrink)