Preclinical and Clinical Trial Requirements
Preclinical and clinical trial requirements in Denmark – an overview. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 75.
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 as a condition for a marketing authorization.
As a starting point, an application for a marketing authorization must include results of physico-chemical, biological or microbiological tests, pre-clinical (e.g. pharmacological and toxicological) tests, and clinical trials. However, there is no requirement that such tests and trials must be conducted in Denmark in order to obtain a marketing authorization in Denmark.
2. How are clinical trials funded?
Clinical trials may be funded privately, publicly or in private-public cooperation.
3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?
Both preclinical and clinical trials are subject to authorization from the DKMA. The requirements applicable to preclinical trials are found, i.a., in the Executive Order no. 1245 of 12 December 2005 on good laboratory practice and Executive Order no. 2028 of 14 December 2020 on experiments on animals.
The requirements applicable to clinical trial protocols are found in the Danish Executive Order on Clinical Trials (Executive Order no. 295 of 26 April 2004) and in the Danish Executive Order on Good Clinical Practice (Executive Order no. 695 of 12 June 2013).
Clinical trials must be subjected to both prior scientific and ethical evaluation. A clinical trial of medicinal products may only be conducted if the DKMA has given an authorization for the trial. Furthermore, clinical trials must be approved by the competent national research ethics committee, cf. the Danish Act on Research Ethics Review of Health Research Projects (Consolidated Act no. 1083 of 15 September 2017, “Committee Act”). When assessing a clinical trial application, the DKMA and the competent research ethics committee will also evaluate the trial protocol.1
The trial protocol must include, i.a., detailed information on the purpose, trial design and time schedule of the trial, information on the persons responsible for the trial (sponsor, advisors, investigators, laboratories, hospitals and institutions involved), information on the medicinal product to be investigated, selection criteria for the inclusion and exclusion of subjects, treatment methods, safety evaluation, quality assurance, ethical considerations, record keeping, and financing.
4. What are the requirements for consent by participants in clinical trials?
The matter of consent in connection with clinical trials will as a starting point be subject to both the regulatory legislation and the data protection legislation.
Pursuant to the regulatory legislation, a clinical trial may not be conducted before the informed consent of the participants have been obtained. Such informed consent must be obtained based on detailed written and orally provided information on the contents, anticipated risks and benefits of the trial. It must also be made clear to the participants that the consent can be withdrawn at any time.
The informed consent required pursuant to the regulatory legislation must not be confused with the consent required as a legal ground for the processing of personal data under Regulation (EU) 2016/679 of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (“GDPR”). The two consents – the consent to participate in the trial and the consent for the processing of personal data – must be obtained separate from each other. Pursuant to the GDPR, a consent must be freely given, specific, informed and an unambiguous indication of the subject’s wishes.
In a recent opinion of 23 January 2019 regarding the interplay between the regulation of clinical trials and the GDPR, the European Data Protection Board has emphasized the use of other legal bases beside consent in the context of clinical trials. Therefore, the use of consent as the legal basis for processing clinical trial data may be limited and other more appropriate legal bases should be identified.
5. May participants in clinical trials be compensated?
As a starting point, it is not permitted to pay subjects for participation in clinical trials. However, subject to strict limitations, it may be permitted to provide compensation for i) loss of income, ii) travel expenses, and iii) discomfort. However, it must be ensured that any compensation provided to trial participants does not affect the giving of consent.
The Danish National Research Ethics Committee has published guidelines on the permitted compensation of participants in health research projects.
6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
The Committee Act provides that it is a requirement that there is a compensation or indemnification arrangement if the trial subject suffers any harm or dies as a consequence of the trial, and that an insurance must be taken out or other compensation arrangement must be put in place to cover the liability of the investigator and the sponsor towards the participants.
In Denmark, the Danish Patient Compensation Scheme covers all trial subjects that participate in health research trials in Denmark, which are conducted at public hospitals, with authorised healthcare professionals in the primary healthcare sector, or with private companies under the responsibility of authorised healthcare professionals.
For trials conducted outside the scope of the public healthcare sector, a mandatory patient insurance must be taken out.
The information provided to participants in clinical trials must include information on the rights to file complaints, and the possibility of seeking damages and compensation in case of any harm resulting from the trial.
- Please note that the current system for application for clinical trial authorization will be modified and subject to greater coordination and harmonization across the EU once the new clinical trial regulation becomes applicable.