Droits de l'individu

Analysis of the EDPS on a consultation on questions concerning the treatment of personal data transfers by OLAF

Avis sur les propositions de règelement et de directive en ce qui concerne la pharmacovigilance, JO 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.

Comments on the current discussions in Parliament about the revision of Regulation (EC) No 1049/2001 relating to public access

Avis concernant le rapport final du Groupe de contact à haut niveau UE/Etats-Unis sur le partage d'informations et la protection de la vie privée et des données à caractère personnel, JO C 128, 06.06.2009, p. 1

• nature and scope of an instrument on information sharing: for the sake of legal certainty, the EDPS shares the report's preferred option for the adoption of a legally binding instrument. This general instrument would need to be combined with specific agreements on a case by case basis to reflect the many specificities of data processing in the field of security and justice. The scope of application should also be clearly circumscribed and provide for a clear and common definition of law enforcement purposes at stake;
• redress mechanisms: as one of the most prominent outstanding issues of the report, the availability of adequate means for redress needs to be properly addressed. Strong redress mechanisms, including administrative and judicial remedies, should be available to all individuals, irrespective of their nationality;
• measures guaranteeing the effective exercise of individuals' rights: further work is needed not only with regard to redress and oversight mechanisms, but also concerning the transparency of data processing and the conditions of access and rectification to personal data.