Clinical Trials Regulation: a step in the right direction?

By Thomas Hendicott

On 2 April 2014, the European Parliament voted in favour of the implementation of a new Clinical Trials Regulation (‘Regulation’). This will revoke the current Clinical Trials Directive 2001/20/EC (‘Directive’) and will have a significant impact for companies engaged in clinical trial activities in the EU. It is anticipated that the Regulation will provide a welcome boost for European research and development, resulting in tangible health benefits and economic growth, including a predicted saving of €800m (£660m) per year in regulatory costs. However, it is essential that it is interpreted and applied in a way that respects both patient privacy and commercially confidential information. This article presents a brief synopsis of the major changes and the impact of these changes for pharmaceutical companies running clinical trials in the EU.

The most notable changes to be introduced under the Regulation can be summarised as follows:

The introduction of a Regulation, as opposed to a Directive, means that its provisions will be directly effective in all member states. The Regulation will be binding in its entirety and automatically incorporated into the national laws for all EU member states…

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