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The EU Clinical Trials Regulation: key priorities, purposes and aims and the implications for public health
  1. Mark L Flear
  1. Correspondence to Dr Mark L Flear, School of Law, Queen's University Belfast, 27-30 University Square, Belfast, BT7 1NN, UK; m.flear{at}qub.ac.uk

Abstract

The replacement of the European Union (EU) Clinical Trials Directive by the new Clinical Trials Regulation (CTR), which entered into force on 16 June 2014 but will not apply before 28 May 2016, provides an opportunity to review the legal and political context within which this important aspect of research law and policy sits and reflects on the implications for public health. My aim in this article is to relate the context to the key purposes and aims of EU law and policy on clinical trials to explain and clarify its orientation. On that basis, I argue that the CTR and the changes it introduces to the law on clinical trials are part of the EU's continued focus on market optimisation. It is this focus that orients and directs the pharmaceutical development pipeline as a whole, but that undermines the achievement of key public health objectives.

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