Belgium adopts law to prepare for Clinical Trials Regulation implementation

On 20 April 2017, the Law on clinical trials with medicines for human use was adopted to ensure the practical implementation of the EU Clinical Trials Regulation (CTR) in Belgium. The law aims at strengthening Belgium's position at the forefront of medical research within the EU (Belgium is preceded only by Denmark in terms of the highest number of clinical trials per inhabitant).

The law will enter into force once the CTR becomes applicable, which is currently estimated to be around November 2018. For any experiments that fall outside of the scope of the CTR, such as non-interventional studies, the current law on experiments on humans dated 7 May 2004 will remain applicable.

The new law designates the Federal Agency for Medicines and Health Products (FAMHP) as the competent authority under the CTR, which will act as the single point of contact for pharmaceutical companies conducting a clinical trial in Belgium. It also establishes an independent assembly (Collège) within the Belgian Ministry of Health that will be responsible for assigning clinical trial applications to an ethics committee for evaluation, and further reduces the number of ethics committees (currently 24) in order to reinforce their expertise.

The evaluation period for clinical trial applications will be brought in line with the CTR as a result of the new law. However, Phase I clinical trials will continue to be evaluated within the existing shorter time frame of 15 days in order to maintain Belgium's competitive position within the EU. In this respect, Phase-I clinical trial centres will also join a specific certification program under the supervision of the FAMHP.

Similarly to France and Germany, the new framework will be tested in pilot projects in collaboration with the FAMHP, hospitals, ethics committees and the pharmaceutical industry to optimise procedures before the CTR becomes applicable.

A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, April 2017 Issue (Thomson Reuters).