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Simple, Safe And Transparent(?): Preliminary Reflections on the Proposal for a New EU Regulation of Clinical Trials

Published online by Cambridge University Press:  20 January 2017

Marco Rizzi
Marco Rizzi*
Affiliation:
European University Institute
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Abstract

A significant reform is currently under the scrutiny of EU institutions in the field of pharmaceutical risk regulation. With its proposal dated July 17th 2012, the Commission seeks to modernise the legal framework of clinical trials by addressing a series of shortcomings ascribed to the current regime governed by Directive 2001/20/EC (to be repealed by the new legislation). The iter of the reform is proving to be complex and lengthy, the first vote having been delayed to March 2014.While a comprehensive account of such a detailed proposal would defeat the scope of this short report, the analysis will focus on some of the most salient features of the proposed regulation, and attempt to situate them in the international context of pharmaceutical regulation.

Type
Reports
Information
European Journal of Risk Regulation , Volume 4 , Issue 4 , December 2013 , pp. 534 - 538
Copyright
Copyright © Cambridge University Press 2013

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References

1 Commission Proposal for a Regulation of the European Parliament and of the Council on Clinical Trials on Medicinal Products for Human Use, and Repealing Directive 2001/20/EC, COM(2012) 369.

2 Council Directive 2001/20/EC on good clinical practice in the conduct of clinical trials on medicinal products for human use, OJ 2001 L 121/34.

3 Gøtsche, Peter C., Jørgensen, Anders W., “Opening up Data at the European Medicines Agency”, BMJ (2011), 342:d2686CrossRefGoogle Scholar

4 Commission Directive 2005/28/EC laying down principles and detailed guidelines for good clinical practices, OJ 2004 L 136/34.

5 Report on the Proposal for a Regulation of the European Parliament and of the Council on Clinical Trials on Medicinal Products for Human Use, and Repealing Directive 2001/20/EC, ENVI, A7-0208/2013. Articles cited in the section are referred to this document.

6 AIM, ISDB, MiEF, WEMOS. Proposed regulation on clinical trials: joint analysis. <http://english.prescrire.org/en/79/207/46302/2507/2506/SubReportDetails.aspx> (last accessed November, 2013).

7 Peter C. Gøtsche, “Deficiencies in Proposed New EU Regulation of Clinical Trials”, BMJ (2012), 345:e8522.

8 Report on the Proposal, supra note 5, p. 147.

9 EMA, “Clinical Trials Submitted in Marketing Authorization to Applications to EMA: Overview of Patients recruitment and the Geographical Location of Investigator Site”, Doc. Ref. EMA/INS/GCP/154352/2010, 5 November 2010, available at <http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/12/WC500016819.pdf> (last accessed May 2013).

10 Berman, Ayelet, “The Role of Domestic Administrative Law in the Accountability of IN-LAW: The Case of the ICH” in Pauwelyn, J., Wessel, R., Wouters, J. (eds.) Informal International Lawmaking: Mapping the Action and Testing Concepts of Accountability and Effectiveness (Oxford: Oxford University Press, 2012)Google Scholar

11 EU Commission, “Note for the attention of the Trade Policy Committee – Annex III Initial Position Paper on Pharmaceuticals”, 20 June 2013, available at <http://www.iatp.org/files/TPC-TTIPnon-Papers-for-1st-Round-Negotiatons-June20-2013.pdf> (last accessed November 2013).