Regulation Of Innovative Pharmaceuticals In The EU And US: A Comparative Analysis
L218 25 2001
University Of Sussex
Professor JW Abraham
April 2001 - March 2004
Website
Abstract
Combining theories of citizenship with documentary plus interview field methods, the proposed research will compare the regulation of innovative pharmaceuticals in the EU and the US from 1995 to 2000. It will do this:
(i) by focusing on, and explaining, the inconsistencies in approvals/withdrawals of the same innovative pharmaceuticals between these European and American regulatory systems; and
(ii) by considering how these regulatory systems can respond to recent, and potential future, challenges, such as the cost-effectiveness and appropriate therapeutic use of some new innovative pharmaceuticals, which command extensive medical and public demand, and the possible introduction of greater transparency and comparative effectiveness into regulatory agencies' risk-benefit assessments of innovative pharmaceuticals.
Summary
Background
In principle, the purpose of pharmaceutical regulation is to promote and protect public health by creating a regulatory framework which encourages the pharmaceutical industry to produce safe and innovative new products needed by patients, and which prevents the marketing of unsafe and/or ineffective products. How pharmaceutical regulation is conducted raises important questions about citizenship rights to property and to public health. For example, it poses the problem of identifying the appropriate balance between pharmaceutical companies' intellectual property rights about their products and wider public rights of access to information about drug safety testing. The proposed research aims to provide the first systematic social scientific research on the EU's regulation of innovative pharmaceutical products, - administered by the new European Medicines Evaluation Agency (EMEA) since 1995 - by comparing the regulation of innovative pharmaceuticals in the EU and the US from 1995 to 2000.
Research Design
Combining theories of citizenship with documentary plus interview field methods, the proposed research will compare the regulation of innovative pharmaceuticals in the EU and the US from 1995 to 2000. It will do this:
(i) by focusing on, and explaining, the inconsistencies in approvals/withdrawals of the same innovative pharmaceuticals between these European and American regulatory systems; and
(ii) by considering how these regulatory systems can respond to recent, and potential future, challenges, such as the cost-effectiveness and appropriate therapeutic use of some new innovative pharmaceuticals, which command extensive medical and public demand, and the possible introduction of greater transparency and comparative effectiveness into regulatory agencies' risk-benefit assessments of innovative pharmaceuticals.
Policy and Academic Implications
The focus on inconsistent regulatory outcomes about the same products is a particularly promising methodology for social scientific explanation because by involving the pharmaceutical technologies themselves it brings regulatory science into the analysis, while pointing to social, economic and political explanatory factors because international differences in the technological nature of the regulatory outcomes are absent (i.e. 'controlled for'). In attempting to explain these inconsistencies, the proposed research will explore the sociological features of the regulatory science in the EU and US, regulator-industry relations, transparency and citizen access to the regulatory process, and the review of regulatory decision making by the courts and the EU Parliament/US Congress. The research will enable social science to inform future regulatory policy on innovative pharmaceutical products in the EU and the US
Contacts
Outputs
Conference Papers
Abraham, J. (Oral) The Science and Politics of Medicines Control. International Society of Pharmacovigilance. 2001, Tunis.
Abraham, J. (Oral) The Public Health Implications of Fast-tracking Medicines Regulation in Europe. Health Action International. 2001, Frankfurt.
Books
The Regulation of the Pharmaceutical Industry. (2002) Eds. John Abraham, Professor of Sociology at the University of Sussex and Helen Lawton Smith. More information - pdf..
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