New Royal Decree organizes the supervision of clinical trials
Following the European Regulation on clinical trials on medicinal products for human use, the Belgian legislator adopted a law on 7 May 2017 applying this Regulation in the Belgian legal landscape. The implementation of this law now takes effect with the Royal Decree of 9 October 2017, as published in the Belgian Official Journal on 10 November 2017.
The legislator’s intention, as set out in the new Royal Decree, is to adopt a new concept of ethics committees. Among other requirements, each committee must appoint a patients’ representative, who will join the committee. For the assessment of clinical trials in phase I, the ethics committee must also include a healthy volunteer who has already participated in a clinical trial in phase I.
The Royal Decree also contains requirements that an ethics committee must meet to be accredited, including having in place a quality system and a registration and management system for conflicts of interest of the members. In addition, the ethics committee must be operated either by one or more authorized hospitals and other care establishments, by the Ministry of National Defense, or by a legal entity meeting specific conditions. These conditions include the following: the legal entity must not be profit driven and its exclusive statutory purpose must be the operation of an ethics committee. Finally, the legal entity may not have any link with a marketing authorization holder of medicinal products.
An application for the accreditation of an ethics committee must be submitted to the Federal Agency for Medicines and Health Products (“FAMHP”). The FAMHP will then verify whether all the documents submitted comply with legal requirements. Accordingly, the Minister will grant the committee the accreditation. This accreditation may, at the request of the FAMHP or the College, be suspended or revoked by the Minister. The College decides which ethics committee will provide advice on a particular clinical trial. This committee does not have to be the ethics committee on the trial site.
The College is also a new body that has been created by the new Belgian regulation. It will act as the single point of contact between the different ethics committees and the FAMHP. In addition, it will coordinate, harmonize, support, evaluate and follow up on the ethics committees.
The provisions of the Royal Decree and the law concerning the composition, functioning and accreditation of the ethics committees and the College entered into force on 20 November 2017. The other provisions enter into force along with the European Regulation when the EU portal and the EU database on clinical trials have become operational. The exact date is still undetermined, but the entry into force is scheduled for 2019 according to the European Medicines Agency.
[1] Regulation (EU) no. 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Verordening (EU), Official Journal 27 May 2014, 158, 1, http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32014R0536&from=EN .
