Reforming the EU Clinical Trials Directive: Streamlining Processes or a Radical “New” Agenda?

in European Journal of Health Law
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From its conception the EU Clinical Trials Directive met with controversy. Some saw it as an unnecessary inhibitor to scientific research, introducing bureaucracy which was unduly expensive, slowing down the clinical trial approval system. The Directive however also enshrined respect for fundamental rights in relation to clinical trials decision-making and impacted upon the domestic law of member states facilitating the alignment of trial review processes. Nearly a decade after its implementation the EU is moving towards implementation of further reform in this area, from a Directive to a Regulation, from a system placing the research ethics system at the heart of the clinical trials approval committee to one which does not and which represents a see change in international and domestic approaches to research ethics. This article critically examines the proposed reform of the regulation of clinical trials on medicinal product through the introduction of a new EU Regulation and asks whether this can be seen as a natural streamlining of processes or a radical new agenda in EU health law and regulation.




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K. Robinson and P.J.D. Andrews, “ ‘(More) trials and tribulations’; the effect of the EU directive on clinical trials in intensive care and emergency medicine, five years after its implementation” Journal of Medical Ethics 36(8) (2010) 322-325.


See further J. Hearn and R. Sullivan, “The impact of the Clinical Trials Directive on the cost and conduct of non-commercial cancer trials in the UK”, European Journal of Cancer 43 (2007) 8-13.


R. Hogg, “The EU Clinical Trials Directive: 3 years on”, The Lancet 369 (2007) 1777-8.


See H. Nys, “New European Rules Regarding the Approval of Clinical Trials, the Role of Research Ethics Committees and the Protection of Subjects”, Arch. Immunology. Ther. Exp. 60 (2012) 405-414.


R. Hernandz et al.,“Harmonisation of ethics committees practice in 10 European countries”, Journal of Medical Ethics 35 (2013) 696-700.


See further H. Nys, “Comparative Health Law and the Harmonisation of Patients’ Rights in Europe”, European Journal of Health Law 8 (2001) 317-331, at 324.


See generally P. McNeill, “Paying People to Participate in Research: Why Not?”, Bioethics 11 (1997) 393; M. Wilkinson and A. Moore, “Inducements in Research”, Bioethics 11(1997) 373 ; J.P. Bentley and P. G. Thacker, “The Influence of Risk and Monetary Payment on the Research Decision Making Process” Journal of Medical Ethics 30(2004) 293.


See further Nys, supra note 28 at p. 412.


See further, E.A. Singer and M. Mullner, “Implications of the EU Directive on clinical trials for emergency medicine”, BMJ 324(2002) 1169.


See further R. Watson, “EU legislation threatens clinical trials”, BMJ (2003)1348’; and Editorial “Who’s afraid of the European Clinical Trials Directive?”, Lancet 361 (2003) 9378.


See Nys, supra note 28 at p. 414.


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