Access to essential medicines: Public health and international law

Historically, there have been intense conflicts over the ownership and exploitation of pharmaceutical drugs and diagnostic tests dealing with infectious diseases. Throughout the 1980’s, there was much scientific, legal, and ethical debate about which scientific group should be credited with the discovery of the human immunodeficiency virus, and the invention of the blood test devised to detect antibodies to the virus. In May 1983, Luc Montagnier, Françoise Barré-Sinoussi, and other French scientists from the Pasteur Institute in Paris, published a paper in Science, detailing the discovery of a virus called lymphadenopathy (LAV). A scientific rival, Robert Gallo of the National Cancer Institute, identified the AIDS virus and published his findings in the May 1984 issue of Science. In May 1985, the United States Patent and Trademark Office awarded the American patent for the AIDS blood test to Gallo and the Department of Health and Human Services. In December 1985, the Institut Pasteur sued the Department of Health and Human Services, contending that the French were the first to identify the AIDS virus and to invent the antibody test, and that the American test was dependent upon the French research. In March 1987, an agreement was brokered by President Ronald Reagan and French Prime Minister Jacques Chirac, which resulted in the Department of Health and Human Services and the Institut Pasteur sharing the patent rights to the blood test for AIDS. In 1992, the Federal Office of Research Integrity found that Gallo had committed scientific misconduct, by falsely reporting facts in his 1984 scientific paper. A subsequent investigation by the National Institutes of Health, the United States Congress, and the US attorney-general cleared Gallo of any wrongdoing. In 1994, the United States government and French government renegotiated their agreement regarding the AIDS blood test patent, in order to make the distribution of royalties more equitable... The dispute between Luc Montagnier and Robert Gallo was not an isolated case of scientific rivalry and patent races. It foreshadowed further patent conflicts over research in respect of HIV/AIDS. Michael Kirby, former Justice of the High Court of Australia diagnosed a clash between two distinct schools of philosophy - ‘scientists of the old school... working by serendipity with free sharing of knowledge and research’, and ‘those of the new school who saw the hope of progress as lying in huge investments in scientific experimentation.’ Indeed, the patent race between Robert Gallo and Luc Montagnier has been a precursor to broader trade disputes over access to essential medicines in the 1990s and 2000s. The dispute between Robert Gallo and Luc Montagnier captures in microcosm a number of themes of this book: the fierce competition for intellectual property rights; the clash between sovereign states over access to medicines; the pressing need to defend human rights, particularly the right to health; and the need for new incentives for research and development to combat infectious diseases as both an international and domestic issue.

Julia Gillard, Big Pharma, patent law and public health

It takes a lot of bravery for governments to stand up to big business. But the Gillard government has shown a lot of guts during its tenure. It stood up to Big Tobacco in the battle over plain packaging of tobacco products and has defended individuals and families affected by asbestos. It took on Big Oil in its Clean Energy Future reforms and stood up to the resource barons with the mining tax. The government is now considering Big Pharma - the pharmaceutical industry and their patents – and has launched several inquiries into patent law and pharmaceutical drugs...

Law of the Republic of Uzbekistan "On Protection of Mental Health in the Population of Uzbekistan"

The law provides rights for PWD for easy access of public goods, including education, social security, medical treatment, occupational and social rehabilitation and establishes an extent of responsibility of the government and its bodies for the creation of favourable conditions for the social adaptation of PWDs in market environment conditions.

The law and ethics of ‘self-quantified’ health information: An Australian perspective

This exploratory article examines the phenomenon of the ‘Quantified Self’—until recently, a subculture of enthusiasts who aim to discover knowledge about themselves and their bodies through self-tracking, usually using wearable devices to do so—and its implications for laws concerned with regulating and protecting health information. Quantified Self techniques and the ‘wearable devices’ and software that facilitate them—in which large transnational technology corporations are now involved—often involve the gathering of what would be considered ‘health information’ according to legal definitions, yet may occur outside the provision of traditional health services (including ‘e-health’) and the regulatory frameworks that govern them. This article explores the legal and regulatory framework for self-quantified health information and wearable devices in Australia and determines the extent to which this framework addresses privacy and other concerns that these techniques engender, along with suggestions for reform.

European Law and New Health Technologies: The Research Agenda

Maps the research agenda that underpinned the edited collection 'European Law and New Health Technologies', that this pieces introduces.

European Law and New Health Technologies ESRC End of Award Report, RES-451-26-0764

End of award report for the funded research seminar series of the same name.

European Law and New Health Technologies

Health is a matter of fundamental importance in European societies, both as a human right in itself, and as a factor in a productive workforce and therefore a healthy economy. New health technologies promise improved quality of life for patients suffering from a range of diseases, and the potential for the prevention of incidence of disease in the future. At the same time, new health technologies pose significant challenges for governments, particularly in relation to ensuring the technologies are safe, effective, and provide appropriate value for (public) money.

To guard against the possible dangers arising from new health technologies, and to maximize the benefits, all European governments regulate their development, marketing, and public financing. In addition, several international institutions operating at European level, in particular the European Union, the Council of Europe, and the European Patent Office, have become involved in the regulation of new health technologies. They have done so both through traditional 'command and control' legal measures, and through other regulatory mechanisms, including guidelines, soft law, 'steering' through redistribution of resources, and private or quasi-private regulation.

This collection analyses European law and its relationships with new health technologies. It uses interdisciplinary insights, particularly from law but also drawing on regulation theory, and science and technology studies, to shed new light on some of the key defining features of the relationships and especially the roles of risk, rights, ethics, and markets. The collection explores the way in which European law's engagement with new health technologies is to be legitimized, and discusses the implications for biological or biomedical citizenship.

Governing Public Health: EU Law, Regulation and Biopolitics

This book contributes towards EU studies and the growing discourse on law and public health. It uses the EU’s governance of public health as a lens through which to explore questions of legal competence and its development through policy and concrete techniques, processes and practices, risk and security, human rights and bioethics, accountability and legitimacy, democracy and citizenship, and the nature, essence and ‘future trajectory’ of the European integration project. These issues are explored first, by situating the EU's public health strategy within the overarching architecture of governance and subsequently by examining its operationalisation in relation to the key public health problems of cancer, HIV/AIDS and pandemic planning.

The book argues that the centrality and valorisation of scientific and technical knowledge and expertise in the EU's risk-based governance means that citizen participation in decision-making is largely marginalised and underdeveloped – and that this must change if public health and the quality, accountability and legitimacy of EU governance and its regulation are to be improved. Subsequently the book goes on to argue that the legitimating discourses of ethics and human rights, and the developing notion of EU (supra-)stewardship responsibility, can help to highlight the normative dimensions of governance and its interventions in public health. These discourses and dimensions provide openings and possibilities for citizens to power ‘technologies of participation’ and contribute important supplementary knowledge to decision-making.