Preclinical and Clinical Trial Requirements
All legal aspects surrounding preclinical and clinical trial requirements in Belgium. Prepared in association with ALTIUS, a leading law firm in Belgium, this is an extract from The Pharma Legal Handbook: Belgium, available to purchase here for USD 99.
1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?
No, clinical trials are not required to be conducted locally to receive marketing approval in Belgium. In order to obtain marketing approval, for new drugs, the necessary information and data regarding the efficacy, safety and quality of the medicine should be submitted (see also Chapter III, Question 22).
Where the clinical trials have been carried out outside the EU, they must have been conducted in accordance with principles equivalent to those applicable in the EU (in particular with regard to the protection of participants and transparency).
2. How are clinical trials funded?
In Belgium, the funding of clinical trials varies according to the type of trial:
- Commercial clinical trials are funded by pharmaceutical companies (i.e. 77% of trials in 2018) ;
- Non-commercial clinical trials are funded by the State (health care budget) or by universities, foundations or charitable organisations;
- Other clinical trials are funded by scientific research funds or charitable organisations.
3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?
Clinical trials, involving human subjects, are subject to stringent requirements stipulated in the Law of 7 May 2004 on experiments on the human person. These requirements do not apply to preclinical studies which are carried out in vitro or in vivo using lab animals.
To carry out a clinical trial in Belgium, the following requirements should be met :
- The clinical trial is scientifically justified and based on the latest scientific knowledge and a sufficient preclinical experiment;
- The clinical trial aims to increase the knowledge of humans or means that can improve their existence;
- There is not alternative method which is similarly effective and allows to achieve the same results;
- The foreseeable risks and disadvantages have been weighed against the individual benefit for the participant as well as other people;
- The evaluation leads to the conclusion that the expected therapeutic and public health advantages outweigh the risks;
- The participant has provided his/her consent (see also Question 4 below);
- The clinical trial is conducted under the responsibility of a health care professional.
- The investigator and sponsor have taken care of insurance and coverage of their liability (see also Question 5 below).
The investigator must submit a clinical trial application (‘CTA’) to a fully accredited ethics committee and to Minister (with delegated authority to the FAMHP). The CTA includes inter alia the protocol and a summary there-of, investigator’s brochure (‘IB’), investigational medicinal product dossier (‘IMPD’) (in the form of a so-called Common Technical Document – ‘CTD’) and other documents.
The trial protocol shall particularly describe the objective(s), design, methodology, statistical aspects and organization of the clinical trial. The SmPC may replace the IB and IMPD if the investigated medicinal product is authorized in a EU member state and if it is used according to the MA.
The clinical trial may only be carried out under certain conditions, including the approval of an ethics committee and the Minister on the trial protocol.
When the clinical trial is carried out on a minor, an incapable adult or in an emergency, additional conditions are imposed on the ethics committee regarding the approval to be given on the protocol.
4. What are the requirements for consent by participants in clinical trials?
A person may only participate in an experiment if he (or she) has given his (or her) free and informed consent. This consent must be given in writing. Additional conditions must be met in the event that the participant is a minor or an incapable adult or when consent cannot be obtained due to the urgency of the situation.
It is also essential that certain information be provided to the volunteer in advance, in writing and in a clear and understandable manner. This information shall include in particular the nature, scope, objectives, consequences, expected benefits, risks of the experiment, the circumstances in which it takes place and the identification and opinion of the competent ethics committee.
The volunteer must also have been informed that he (or she) may withdraw his (or her) consent at any time and without prejudice.
5. May participants in clinical trials be compensated?
Participants in clinical trials can receive a compensation for participating in the trial, as well as an indemnity for any costs incurred and the time spent on medical research. The indemnity is not determined according to the potential risk incurred.
For a minor, an incapable adult or when consent cannot be obtained due to the urgency of the situation, there can be no incentives, whether financial or not, except for an indemnity of costs incurred.
Additionally, participants also benefit from free treatment that is the subject of the study, and usually also free examinations carried out as part of the clinical trial.
6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
The sponsor is objectively liable for any damage the clinical trial causes to the participants (or, in the event of death, to their beneficiaries), whether the damage is directly or indirectly related to the clinical trial. Any clause stipulating the opposite will be considered null and void.
Prior to the start of the clinical trial, the sponsor must provide insurance to cover its liability and the liability of any intervener in the clinical trial (see also Question 2 above).