EUR-Lex Access to European Union law
This document is an excerpt from the EUR-Lex website
Document 52013XX0903(03)
Executive summary of the Opinion of the European Data Protection Supervisor on the Commission proposal for a regulation on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
Executive summary of the Opinion of the European Data Protection Supervisor on the Commission proposal for a regulation on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
Executive summary of the Opinion of the European Data Protection Supervisor on the Commission proposal for a regulation on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
OJ C 253, 3.9.2013, p. 10–11
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
OJ C 253, 3.9.2013, p. 5–5
(HR)
3.9.2013 |
EN |
Official Journal of the European Union |
C 253/10 |
Executive summary of the Opinion of the European Data Protection Supervisor on the Commission proposal for a regulation on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
(The full text of this Opinion can be found in English, French and German on the EDPS website http://www.edps.europa.eu)
2013/C 253/05
1. Introduction
1.1. Consultation of the EDPS
1. |
On 17 July 2012, the Commission adopted a proposal for a regulation on clinical trials on medicinal products for human use (the proposed Regulation) (1), and repealing Directive 2001/20/EC. This proposal was sent to the EDPS for consultation on 19 July 2012. |
2. |
The EDPS welcomes the fact that he is consulted by the Commission and recommends that a reference to the consultation be included in the preambles of the proposed Regulation. |
3. |
Before the adoption of the proposed Regulation, the EDPS was given the possibility to provide informal comments to the Commission. Some of these comments have been taken into account. As a result, the data protections safeguards in the proposed Regulation have been strengthened. |
1.2. Objectives and scope of the proposed Regulation
4. |
The proposed Regulation aims at facilitating the application process for clinical trials on medicinal products for human use, especially for multinational trials. It contains a legal framework for establishing an EU-wide central database (EU database), controlled by the Commission, as the single application platform for clinical trials in the EU. The proposed Regulation also introduces an electronic database (EMA database), controlled by the European Medicines Agency (EMA), for reporting of suspected unexpected serious adverse reactions. |
1.3. Aim of the EDPS Opinion
5. |
The proposed Regulation may affect the rights of individuals related to the processing of their personal data. Amongst other issues, it deals with the processing of sensitive data (health data), databases and record keeping. |
6. |
Although the EDPS welcomes that the Commission has made an effort to guarantee the correct application of EU rules concerning the protection of personal data in the proposed Regulation, the EDPS has identified certain unclarities and inconsistencies in the way the proposed Regulation deals with the issue of whether and what categories of personal data will be processed under the proposed Regulation, in particular where sensitive data regarding health might be processed and stored. The EDPS therefore sees a need for clarification in relation to this category of personal data, both regarding the authorisation procedure in the EU Portal and database and the reporting of adverse effects in the EMA database. |
3. Conclusions
32. |
The EDPS welcomes the attention paid specifically to data protection in the proposed Regulation, but identified some scope for further improvement. |
33. |
The EDPS recommends that:
|
Done at Brussels, 19 December 2012.
Giovanni BUTTARELLI
Assistant European Data Protection Supervisor
(1) COM(2012) 369 final.