E-DRUG: Draft EU Clinical Trial Regulation must be amended
----------------------------------------------------------
Dear E-Druggers,
On 17 July 2012, the European Commission presented its proposal for a new Regulation on clinical trials that would repeal Directive 2001/20/EC.
On 5 February 2013, AIM, ISDB, MiEF and WEMOS submitted a joint analysis.
On the one hand, the proposed Regulation contains several measures that are welcome, most notably:
- The establishment of a more harmonised application dossier for initial authorisation and substantial modification of clinical trials;
- The creation of a single and improved “EU portal” linked to an EU database;
- The establishment of a national compensation mechanism in all Member States.
On the other hand, the European Commission fails to propose incentives to transform the current corporate-based research and development model into a model that meets real public health needs. And the proposed Regulation could seriously undermine Member States’ responsibility on ethical matters and the level of protection currently afforded to trial participants.
The EU Commission’s proposal needs to be amended by the European Parliament and the Council to protect the rights of human subjects participating in clinical research and to ensure that European Citizens are granted access to information.
The revision of the Clinical Trials Regulation offers major opportunities to improve healthcare in Europe, by:
1. Requiring comparative clinical trials: new medicines to be tested against the “best current proven intervention”
2. Improving citizens’ access to information: public access to clinical study reports;
3. Allowing for early detection of safety concerns;
4. Discouraging the conduct of unethical trials in developing countries.
More details at: http://english.prescrire.org/en/79/207/46302/2507/2506/SubReportDetails.aspx
Christophe Kopp
Editor with Prescrire
Website: english.prescrire.org
ckopp@prescrire.org