Clinical Trials Abroad: The Marketable Ethics, Weak Protections and Vulnerable Subjects of EU Law

Research output: Chapter in Book/Report/Conference proceedingChapter (peer-reviewed)peer-review

Abstract

This chapter explores how the EU is a largely overlooked exporter of normative power through its facilitation and use of clinical trials data produced abroad for the marketing of safe pharmaceuticals at home; a move that helps to foster the growing resort to pharmaceuticals as a fix for public health problems. This is made possible by the EU’s (de)selection of international ethical frameworks in preference to the international technical standards it co-authors with other global regulators. Clinical trials abroad underscore how ethics are contingent and revisable in light of market needs, producing weak protections for the vulnerable subjects of EU law. I argue that these components and effects of the regime are ultimately about that which undergirds, shapes and directs regulatory design. That is, I point to the use, infiltration, perpetuation and extension of market-oriented ideas, values and rationalities into formally non-market domains like biomedical knowledge production and public health. I explain how these are central to efforts at producing and legitimating the EU, its related imagined socio-political order based on a more innovative, profitable and competitive pharmaceutical sector in order to foster economic growth, jobs and prosperity, and with them the project of European integration. ‘Bioethics as risk’ is highlighted as a way to reshape and redirect the regulatory regime in ways that are more consistent with the spirit and letter of the ethical standards (and through them the human rights) the EU claims to uphold.
Original languageEnglish
Title of host publicationCambridge Yearbook of European Legal Studies: 2013-2014 Volume 16
EditorsAlbertina Albors-Llorens, Kenneth Armstrong, Markus W Gehring
Place of PublicationOxford
PublisherHart Publishing
Pages75-108
Number of pages33
Volume16
ISBN (Electronic)9781782255796
ISBN (Print)9781849466288
Publication statusPublished - Jan 2015

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