Droits de l'individu

Letter regarding a consultation on special ID cards issued by the Ministry of Foreign Affairs for non Portuguese staff

Avis concernant la proposition de règlement du Conseil modifiant le règlement (CE) n° 881/2002 instituant  certaines mesures restrictives spécifiques à l'encontre de certaines personnes et entités liées à Oussama ben Laden, au réseau Al-Qaida et aux Taliban, JO C 276, 17.11.2009, p. 1

Analyse du CEPD sur une consultation concernant le traitement de données à caractère personnel dans le cadre de la procédure en cas de pandémie élaborée par la BCE (Dossier 2009-456)

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.