On 2 April 2014 European Parliament formally approved a proposed Regulation on clinical trials on medicinal products for human use.
The current law governing clinical trials throughout the EU is dealt with by the Clinical Trials Directive (2001/20/EC). This has been criticised amongst patients, researchers and those involved in the industry for having disproportionate regulatory requirements, which has in turn contributed towards a significant decline in the number of clinical trials conducted in the EU.
The new Regulation will aim to increase the transparency of clinical trials and make it easier to conduct cross-border trials. Below is a summary of some of the main changes which have been proposed:
In order to improve transparency, some of the requirements will include that:
- data which is submitted in support of a clinical trial application should be based solely on clinical trials which have been recorded in a publicly accessible, free of charge database;
- all clinical trials should be registered in the EU database prior to being started;
- once a decision on marketing authorisation has been made or the marketing authorisation application has been withdrawn, the data included in clinical study reports will not be considered to be commercially confidential;
- irrespective of the outcome of a clinical trial, within one year from the end of a clinical trial in all Member States concerned, the sponsor (being an individual, company, institution or organisation which takes responsibility for the initiation, management and for setting up the financing of the clinical trial) shall submit to the EU database a summary of the results of the clinical trial;
- simplification of the authorisation procedure
These transparency requirements may for some businesses have significant commercial implications.
In order to become law the Regulation will now need to be adopted by the Council of Ministers under the ordinary legislative procedure. It will be directly applicable in all EU Member States, therefore it will not require implementation into national law. The Regulation is expected to come into effect by mid-2016 at the earliest.
If you have any questions on the new Regulation please contact Beverley Flynn on 01483 734264.