New Commission proposal on clinical trials

On 17 July, the Commission proposed a new Regulation to simplify the rules for conducting clinical trials, with the aim to boost medicine research in the EU. With over 20 billion Euros of investment per year clinical research contributes significantly to the economic growth – the main priority for the EU at this moment. Once implemented, the measures will speed up the authorisation and reporting procedures, while maintaining high standards of patient safety and reliability of data. The measures will also help to differentiate the obligations in line with the risk-profile of the trial. 

Once agreed, the proposed Regulation will replace the 2001 Clinical Trials Directive. This has ensured high level of patient safety; however, it has also led to an unfavourable regulatory framework for clinical research, and has contributed to a 25% decrease in clinical trials during the period 2007-2011.

Some of the Regulation’s concrete proposals are:

• An authorisation procedure for clinical trials: this will support a fast assessment of the application by all Member States concerned. It will also ensure one single assessment outcome.
• Simplified reporting procedures: this will avoid the submission of largely identical information on the clinical trial separately to various bodies and Member States.
• More transparency on recruitment for participating in a clinical trial and on its results.

The Regulation also facilitates cross-border trials; these are particularly important for rare diseases, where there are often too few potential trial patients in a single country. 

Member states have reacted positively to the proposal; the pharmaceutical industry has expressed concerns about the feasibility of its application given the complex division of competences between the EU and national levels. 

The legislative proposal will now be discussed in the European Parliament and in the Council. It is expected to come into effect in 2016.

EuGMS has submitted suggestions for changes to the proposal with the aim to improve the situation of inclusion of older people in clinical trials and is now in the process of analysing the text to see whether our suggestions have been taken into account.