Draft opinion: Klinisch onderzoek met geneesmiddelen voor menselijke gebruik

Committee on Civil Liberties, Justice and Home Affairs, Draft opinion, Clinical trials on medicinal products for human use, and repeal of Directive, 2001/20/EC-PE 506.211v03-00

Het voorstel heeft tot doel het stimuleren en faciliteren van klinisch onderzoek, door de huidige regels voor de uitvoering van deze studies met geneesmiddelen te vereenvoudigen. Het voorstel bestaat onder anderen uit het tot stand brengen van een elektronische database, de EMA-database, en een centrale database voor klinische proeven binnen de EU. Rapporteur, Juan Fernando López Aguilar, zet het voorstel uiteen met daarop volgend het amendement.

The proposal aims at boosting and facilitating clinical research in the EU by simplifying the current rules for conducting clinical trials on medicinal products for human use. The proposal will replace current Directive 2001/20/EC by a Regulation which will establish a modern uniform legal framework at EU level, cutting red-tape and ending with national divergences in the implementation of Directive 2001/20/EC.

The proposal provides for the establishment of an electronic database (the EMA database), controlled by the European Medicines Agency (EMA) for the reporting of suspected unexpected serious adverse reactions. It also provides for the establishment of an EU-wide central data base (EU database) controlled by the Commission, as the single application platform for clinical trials in the EU.

 

It is essential that the future Regulation ensures the full respect of the EU Charter of Fundamental Rights.(...) The conducting of clinical trials implies the processing of personal data at several levels (at least sponsors, investigators, processors, EU Commission and the EMA). Personal data processed shall relate to different categories of data by which subjects are affected (...)

The Electronic database for reporting, established by the European Medicines Agency (EMA) (...) should only contain pseudonymised data (key coded data) that only enable the identification of the data subject at the level of those who actually would need this information (...), whereas this would render direct identifiably of the data subject in the EMA database impossible.

The purpose of the EU database,(Article 78), of is to streamline and facilitate the flow of information between sponsors and Member States and between the Member States. (...) It provides for the "inclusion of personal data in the EU database insofar as this is necessary for the purposes for which the database is established". (...)

The amendments proposed will improve the legal certainty of the proposal and will strengthen the safeguards and protections of individuals (...)