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Pharmacovigilance

22
Apr
2009

Pharmacovigilance

Opinion on the proposals for a Regulation and for a Directive on pharmacovigilance, OJ C 229, 23.09.2009, p. 19

The EDPS takes the view that the lack of a proper assessment of the data protection implications of pharmacovigilance constitutes one of the weaknesses of the current legal framework set out by Regulation (EC) No 726/2004 and Directive 2001/83/EC. The current amendment of Regulation (EC) No 726/2004 and Directive 2001/83/EC should be seen as an opportunity to introduce data protection as a full-fledged and important element of pharmacovigilance.

A general issue to be addressed thereby is the actual necessity of processing personal health data at all stages of the pharmacovigilance process. As explained in this Opinion, the EDPS seriously doubts this need and urges the legislator to reassess it at the different levels of the process. It is clear that the purpose of pharmacovigilance can in many cases be achieved by sharing information on adverse effects which is anonymous in the meaning of the data protection legislation. Duplication of reporting can be avoided through the application of well structured data reporting procedures already at national level.