On 22 May 2017, the new Belgian law of 7 May 2017 on clinical trials on medicinal products for human use was published in the Official Belgian Journal. This law is in response to Regulation No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use1. The objective of this Regulation is to harmonize clinical trial procedures between EU Member States.
The Regulation aims to ensure the safety of participants in clinical trials, while at the same time promote scientific and technological progress. It wants quick access to new, innovative treatments, ensuring that the Union remains an attractive place for conducting clinical trials and maintaining the competitiveness of European clinical research. The Regulation also guarantees greater transparency in the execution of clinical trials through the EU portal that will be set up for this purpose. This portal will serve as a focal point for the submission of data and information about clinical trials. The data that is submitted via the EU portal will be saved in the EU database.
Once entered into force, this Regulation will be directly applicable in Belgium. The new Belgian law addresses the issues the Regulation has left up to the Member States.
The law appoints the Federal Agency for Medicines and Health Products (“FAMHP”) as the point of contact that ensures all communication through the EU portal. In addition, the Ethical Committee, responsible for the ethical review, also plays an important role. The FAMHP and the Committee are jointly charged with the assessment of clinical trials. The Minister or his deputy, namely the General Administrator of the FAMHP, decides on the admission of the clinical trial, but his decision must not differ from the joint conclusions of the FAMHP and the Ethical Committee.
Finally, a College within the Federal Public Health Service will be established. This College is an independent body that coordinates the functioning of the Ethical Committee and monitors its quality. All communication between the FAMHP and the Ethical Committee takes place through the College.
The Belgian law enters into force at the same time as the Regulation, namely six months after the publication of the communication from the Commission that the EU portal and the EU database on clinical trials had become operational.
Clinical trials in Belgium are currently governed by the law of 7 May 2004 on experiments on human beings. This law, however, has a wider scope than the Regulation. In the Regulation, “clinical trial” is defined as follows:
“A clinical study which fulfils any of the following conditions:
(a) the assignment of the subject to a particular therapeutic strategy is decided in advance and does not fall within normal clinical practice of the Member State concerned;
(b) the decision to prescribe the investigational medicinal products is taken together with the decision to include the subject in the clinical study; or
(c) diagnostic or monitoring procedures in addition to normal clinical practice are applied to the subjects.”2
However, the law of 7 May 2004 as it applies to experiments on human beings defines “experiment” as “any test, study or research carried out on a human person, for the development of the knowledge specific to the exercise of the health care professions”.3
As a consequence, even after the entry into force of the new law of 7 May 2017 and the Regulation on clinical trials, the law of 7 May 2004 will still apply to experiments on human beings outside the scope of the Regulation.
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, https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2014_536/reg_2014_536_en.pdf.
2 Article 2, (2) Regulation No 536/2014.
3 Article 2, 11° of the law of 7 May 2004 on experiments on human beings.