Everyone is entitled to protect their personal information. Data protection is a fundamental right, protected by European law and enshrined in Article 8 of the Charter of Fundamental Rights of the European Union. EDPS Factsheet 1 provides you with information on your data protection rights and how to exercise them.
Avis sur différentes propositions législatives instituant certaines mesures restrictives spécifiques à l'encontre de la Somalie, du Zimbabwe, de la Corée du Nord et de la Guinée, JO C 73, 23.03.2010, p.1
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.
Lettre à propos des traitements de données effectués dans le cadre des bases de données de gestion des plaintes et "EU Pilot" de la Commission (Dossiers 2008-489 et 2008-490)
