Pharmaceutical Fraud, Intellectual Property Rights, and Knowledge Governance: A Human Rights Perspective

Trudo Lemmens, Scholl Chair in Health Law and Policy, University of Toronto; 2012-13: Faculty Member, Centre for Transnational Legal Studies (London), and Academic Visitor, HeLEX Centre and Faculty of Law, University of Oxford

Industry control over the production, distribution and use of pharmaceutical safety and efficacy data is a serious global public health and health care funding concern. A panoply of recent controversies, several of them involving the hiding of clinical trials data or their misrepresentation in some of the most influential medical journals, highlight the urgency of enhancing pharmaceutical knowledge governance. In response to pressure from the scientific community and advocacy groups, various drug regulatory agencies and other organizations are taking active steps to promote data transparency. The European Medicines Agency, for example, recently introduced a new transparency policy for the data it receives in the context of the drug regulatory process. Pharmaceutical companies are now challenging the EMA’s policy before the European Court of Justice, invoking among other things TRIPS-related obligations and commercial secrecy of data.

This presentation will discuss the transparency issue from a human rights perspective. Following a brief discussion of the challenges associated with the current knowledge deficit, the presentation will show how various human rights associated interests can be invoked to support the claim that states have an obligation to actively contribute to reliable knowledge production systems. Human rights-based arguments provide a solid basis to reject the claim that states have a TRIPS-based obligation to protect the secrecy of clinical trials data. The presentation will further discuss the need for 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, aimed at the protection of the public, in combination with other socio-cultural, legal, and economic factors, have in fact increased industry control over pharmaceutical knowledge production. This finding should inform needed reforms of pharmaceutical governance, both nationally and internationally.

The presentation will be based on one forthcoming and one recent publication:

Trudo Lemmens, “Global Pharmaceutical Knowledge Governance: A Human Rights Perspective” Journal of Law, Medicine and Ethics (2013) 41(1). Available at SSRN: http://ssrn.com/abstract=2228068
Trudo Lemmens and Candice Telfer, “Access to Information and the Right to Health: The Human Rights Case for Clinical Trials Transparency” American Journal of Law and Medicine, Vol. 38, pp. 63-112, 2012. Available at SSRN: http://ssrn.com/abstract=1932436