The EU Clinical Trials Regulation: key priorities, purposes and aims and the implications for public health

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 re...

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Bibliographic Details
Published in:Journal of medical ethics 2016-03, Vol.42 (3), p.192-198
Main Author: Flear, Mark L
Format: Article
Language:English
Subjects:
Bioethics
Clinical trials
Clinical Trials as Topic - ethics
Clinical Trials as Topic - legislation & jurisprudence
Company business management
Drug Industry - legislation & jurisprudence
Drug regulation
Ethics
European Commission
European Parliament
European Union
Government regulation
Health Care Sector - legislation & jurisprudence
Health Care Sector - trends
Health Policy - legislation & jurisprudence
Health Policy - trends
Humans
Laws, regulations and rules
Legislation
Legislation, Medical - standards
Legislation, Medical - trends
Management
Marketing
Pharmaceuticals
Pipelines
Policy Making
Public health
Public Health - ethics
Public Health - legislation & jurisprudence
Public Health - trends
R&D
Research & development
Research ethics
Trials
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Summary: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 to reflect 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 in order 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 wider pharmaceutical development pipeline, but that undermines the achievement of key public health objectives.
ISSN:0306-6800
1473-4257
DOI:10.1136/medethics-2015-103258