The EU Clinical Trials Regulation: Key Priorities, Purposes and Aims and the Implications for Public Health


Autoria(s): Flear, Mark L.
Data(s)

01/03/2016

Resumo

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.

Formato

application/pdf

Identificador

http://pure.qub.ac.uk/portal/en/publications/the-eu-clinical-trials-regulation-key-priorities-purposes-and-aims-and-the-implications-for-public-health(53ae37d9-23e7-47ac-933e-b973b4902742).html

http://dx.doi.org/10.1136/medethics-2015-103258

http://pure.qub.ac.uk/ws/files/24495028/The_EU_Clinical_Trials_Regulation_Key_Priorities_Purposes_and_Aims_and_the_Implications_for_Public_Health.pdf

Idioma(s)

eng

Direitos

info:eu-repo/semantics/openAccess

Fonte

Flear , M L 2016 , ' The EU Clinical Trials Regulation: Key Priorities, Purposes and Aims and the Implications for Public Health ' Journal of Medical Ethics , vol 42 , no. 3 , pp. 192-198 . DOI: 10.1136/medethics-2015-103258

Tipo

article