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European Network of Centres for Pharmacoepidemiology and Pharmacovigilance
News article12 March 2020European Medicines Agency

Discussion paper on the general data protection regulation: secondary use of data for medicines and public health purposes

The European Medicines Agency (EMA) is preparing guidance in the form of “Questions and Answers” on the impact of EU data protection legislation on the secondary use of health data in support of the development, evaluation and supervision of medicines.

Therefore, EMA would like to gather input from patients, consumers and healthcare professionals as data contributors as well as from medicines developers, research-performing and research-supporting infrastructures and other data providers (e.g. payers of healthcare). In the context of the General Data Protection Regulation (EU) 2016/679 (GDPR) and focusing on nine key topics outlined in the below discussion paper, EMA would appreciate to receive feedback on specific data protection questions on secondary data use.

The contributions can be sent by 10 July 2020 to the following functional mailbox: dpconsultationatema [dot] europa [dot] eu (dpconsultation[at]ema[dot]europa[dot]eu)


Related information:

12 MARCH 2020
2020 Discussion Paper The General Data Protection Regulation
(525.72 KB - PDF)


»  EMA Big Data webpage (Section: data protection)


Publication date
12 March 2020
European Medicines Agency