Pharmaceutical Knowledge Governance: A Human Rights Perspective

Abstract

Available at SSRN: http://ssrn.com/abstract=2228068

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. Various recent controversies, several of them involving the hiding of data and the misrepresentation of scientific data in some of the most influential medical journals, highlight the urgency of enhancing pharmaceutical knowledge governance. This paper analyzes this issue from a human rights perspective. The paper first identifies the global 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 reliable knowledge production systems, for example through ensuring transparency of data. 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, aimed at the protection of the public, in combination with other socio-cultural and economic factors, have in fact increased industry control over pharmaceutical knowledge production. This finding should inform needed reforms of drug regulation. The paper ends with a recommendation for a comprehensive global response to the problems with pharmaceutical knowledge governance.

Keywords: pharmaceutical regulation, pharmaceutical law, human rights, knowledge governance, right to health, right to information, access to data, transparency, evidence based medicine, clinical trials, data exclusivity, intellectual property, international trade law, TRIPS, fraud

JEL Classification: F13, H23, H41, I18, I10, K23, K13, L15, L65