19 December 2012

The EDPS has issued an opinion on the European Commission's proposal for a Regulation on clinical trials on medicinal products for human use, repealing the Clinical Trials Directive.

The proposal aims to facilitate the application process for clinical trials on medicinal products, especially for multinational trials. It provides a legal framework for the Commission to set up a single point of entry for the submission of data relating to clinical trials and to establish an EU-wide central database (EU database).

It also introduces an electronic database controlled by the European Medicines Agency (EMA) for the reporting of suspected unexpected and serious adverse reactions. The EDPS welcomes that the proposed Regulation explicitly states that clinical trials may only be conducted if personal data is processed in accordance with the Data Protection Directive.

However, the proposal should clarify whether national rules, which implement that Directive, will apply. The EDPS suggests that the proposal should clarify whether personal data concerning health will be processed in the EU database, and if so, for what purpose. In his opinion, the proposal should also include an express reference to the data subjects' right to block their personal data. Further, he considers that it should clearly define in what situations and subject to what safeguards, information containing patient data will be processed and stored in the EMA database.

The Opinion can be found here.