Legal & Regulatory > Luxembourg > Preclinical and Clinical Trial Requirements

Preclinical and clinical trial requirements in Luxembourg – a legal guide. Prepared in association with Wildgen, a leading global law firm, this is an extract from The Pharma Legal Handbook: Luxembourg, 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?

Pursuant to the Grand-Ducal regulation of 15 December 1992 relating to the marketing of medicinal products as amended, clinical trials are not required to be conducted locally as a condition (stated or implicit) for marketing approval.

For trials conducted without the EU, it is required to include a declaration which certifies that the clinical trials conducted meet the requirements of the Directive 2001/20/CE with the application for marketing authorization.

2. How are clinical trials funded?

To our knowledge, most clinical trials are funded by the pharmaceutical industry as well as sponsoring companies.

3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?

It is required by the Grand-Ducal regulation of 30 May 2005 on the application of good clinical practice in conducting clinical trials of medicinal products for human use as amended, that the clinical trial protocols should contain the objective(s), conception, method, statistical aspects and organization of the clinical trial (article 28(h)).

The National Research Ethics Committee (“Comité National d’Ethique de Recherche”, or “CNER”) issue an opinion before the start of the clinical test for which the CNER has been consulted.

4. What are the requirements for consent by participants in clinical trials?

According to article 3 of the Grand-Ducal regulation of 30 May 2005 on the application of good clinical practice in conducting clinical trials of medicinal products for human use as amended, the requirements for consent by participants in clinical trials are the followings:

• the participant to the trial or, where that person is not able to give his informed consent, his legal representative, must have had the opportunity, by an interview with the investigator (the responsible person of the clinical trial) or a member of the group in charge of the trial to understand the objectives of the trial, its risks and drawbacks as well as the conditions in which it will be realized;
•  the participant has been informed of his right to withdraw from the trial at any time;
• the consent should be written; if the person concerned is not able to write, in exceptional cases foreseen by the law, he can give oral consent in the presence of at least one witness.

5. May participants in clinical trials be compensated?

Pursuant to articles 4 and 5 of Grand-Ducal regulation of 30 May 2005 on the application of good clinical practice in conducting clinical trials of drugs for human use as amended, compensation for minor participants and incapable adults in clinical trials are allowed.

6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?

According to article 3 of Grand-Ducal regulation of 30 May 2005 on the application of good clinical practice in conducting clinical trials of medicinal products for human use as amended, the participants in clinical trials are protected and indemnified against any harm that arises as a result of participation in the trial trough three measures:

– a list of prior conditions that a clinical trial must fulfill in order to be undertaken:

1. the foreseeable risks and disadvantages were weighed against the expected benefit for the subject participating in the trial and for other current and future patients. A clinical trial can only begin if the Minister of Health concludes that the therapeutic benefits and in the domain of public health justify the risks and can only continue if compliance with this requirement is constantly monitored;
2. the participant to the trial or, where that person is not able to give his informed consent, his legal representative, must have had the opportunity, by a prior interview with the investigator (the responsible person of the clinical trial) or a member of the group in charge of the investigation to understand the objectives of the clinical trial, its risks and drawbacks as well as the conditions in which it will be realized, and has been informed of his right to withdraw from the clinical trial at any time;
3. the participant’s right for the respect of her/his physical and mental integrity, the participant’s right to privacy shall be respected, as well as the protection of personal data according to the relevant regulations;
4. the participant or, where that person is not able to give his informed consent, his legal representative, has given written consent after being informed of the nature, scope, consequences and the risks of the clinical trial; if the person concerned is not able to write, in exceptional cases provided by law, he can give oral consent in the presence of at least one witness;
5. the participant may withdraw from the clinical trial at any time and without incurring any prejudice;
6. provisions for insurance or indemnity covering the liability of the investigator (the responsible person of the clinical trial) and the sponsor (any person, company, institution or organization responsible for the launching, the management and/ or the funding of the clinical trial) are foreseen.
   – the medical care provided to participants and the medical decisions made about them are the responsibility of a qualified medical practitioner or, where appropriate, a qualified dentist;
   – the participant has a contact point with whom he can obtain additional information.

In any case, the common civil liability for misconduct will be applicable to the investigator and the sponsor.