Version 1.0 - January 2021

Guidance on Insurance and Compensation

1. Insurance of Research Participants

The Scientific Ethics Committee must ensure that there is a compensation or reimbursement scheme in place if a research participant suffers harm or dies as a result of participating in a health science research project. Additionally, insurances or a reimbursement scheme must be established to cover the responsibilities of the research principal and the sponsors towards the participating research subjects.

This is a prerequisite for a research project to be granted permission, as per the committee law § 20 no. 7 (Act no. 1338 of September 1, 2020 concerning the ethical treatment of health science research projects and health data science research projects). This provision in the committee law is applicable to all types of health science research projects, including clinical drug trials, clinical tests of medical equipment, and health data science research projects.

The public patient compensation scheme (the regions) covers all research participants participating in health science research in Denmark conducted in public hospitals, by authorized health professionals in primary healthcare, by private companies under the responsibility of authorized health professionals, and under the auspices of universities and higher education institutions.

Private hospitals, clinics, and specialists conducting trials outside the public healthcare system must obtain mandatory patient insurance. This insurance must cover in accordance with the Ministry of Health and Elderly Affairs' Executive Order no. 488 of May 3, 2018 on insurance obligations. Documentation for this insurance must be provided to the committee during the application for research approval.

All research participants are covered by the national compensation scheme for drug injuries. This coverage includes side effects that go beyond what the injured party should reasonably accept and applies to all drug trials in Denmark.

The Patient Compensation and Drug Injury Compensation scheme is managed by Patient Compensation. They can compensate for financial loss and offer compensation for pain and suffering and/or permanent injury. A statutory co-payment of DKK 7,971 (2021 level) is deducted from the compensation calculation for research patients. This co-payment doesn't apply to healthy research participants.

Decisions by Patient Compensation are made following the rules in the law on complaints and access to compensation within the health service and the Liability for Damages Act. Claims for compensation must be reported to Patient Compensation no later than three years after the entitled party became or should have become aware of the injury. The ultimate limitation period is ten years from the day the injury occurred. More information about the coverage area can be found on the Patient Compensation website .

All healthy research participants are covered by the Occupational Injury Insurance Act.

Patient Compensation does not cover trials conducted by alternative practitioners (non-authorized health professionals). Documentation of alternative insurance must be provided to the committee.

Work injury insurance (covering both occupational accidents and diseases) is mandatory. However, it typically only covers permanent sequelae (permanent injury, loss of earning capacity, and treatment expenses, as well as compensation in case of death, etc.) but not pain and suffering or lost earnings. It only covers healthy research participants. In the case of a municipality, they might be self-insured in certain areas, e.g., regarding accidents. The committees must ensure in their case handling that the coverage is reasonable. Thus, each case requires specific evaluation.

Regular professional liability insurances (professional liability) are based on general compensation rules, i.e., a culpability rule whereby the injurer is liable if the injury can be attributed to them and they acted negligently, with gross negligence, or intentionally.

There appears to be no clear provision in the committee law to require private insurances to cover to the same extent as the patient compensation scheme, which covers more broadly than under general compensation rules due to a more lenient assessment of the causal link between treatment and injury.

For reference (and inspiration), it can be mentioned that the private research institute CCBR has an agreement with Patient Compensation. Under this agreement, Patient Compensation handles compensation cases concerning the company according to the rules of the patient compensation scheme. Following the decisions of Patient Compensation, CCBR's insurance company then pays the compensation.

2. Information for Research Participants on Insurance Conditions

It must always be ensured that the research participants are correctly informed about compensation and reimbursement schemes in the participant information, in accordance with the information regulation § 12, no. 7 (Regulation no. 825 of June 4, 2020 on reportable health science and health data science research projects).

The participant information must clearly state if the research participant is not covered by the patient insurance scheme. At the same time, they should also be informed that regular insurances cover under the general compensation rules of Danish law. If healthy research participants are involved, they should be informed that they are also covered by the Occupational Injury Insurance Act.

If the research participant has to travel abroad in connection with the study, the person responsible for the study must inform the participant about how they are covered during the trip.

The Association of the Danish Pharmaceutical Industry has prepared a brochure on insurance, complaints, and compensation options (PDF).

The brochure has been prepared without the involvement of the authorities, which is why no responsibility can be taken for its content. Sponsors and investigators must, therefore, independently ensure compliance with the legislation. However, the brochure lists some of the questions that research participants may rightfully have, including travel health insurances in Denmark as well as within and outside Europe.

3. Conditions for Compensation

The Complaints and Compensation Act, under which these cases are assessed and settled, distinguishes between trial patients and healthy trial participants.

A trial patient is a patient who participates in a trial concerning their own disease, and where the patient potentially benefits health-wise from participating in the trial. Trial patients are entitled to compensation under the same rules that apply to patients receiving regular non-trial-based treatment. Any compensation requires that the general compensation conditions of the Complaints and Compensation Act are met.

Trial patients participating in drug trials and who, in this context, experience unintended side effects are compensated under the general rules on drug injuries in the Complaints and Compensation Act.

A healthy trial participant is a person who participates in a health science research project, where the trial is not part of the treatment for a disease. Healthy trial participants have extended rights to compensation in two areas compared to trial patients. The first extension is that compensation is provided for any injury that may have been caused by the trial unless it is overwhelmingly likely that the injury has another cause. Therefore, the evidence requirement for the cause of the injury is more lenient compared to general liability rules. The second extension is that the deductible of 7,971 kr. (2021 level) does not apply to healthy trial participants.

In connection with drug trials, healthy trial participants are entitled to compensation for both physical and psychological side effects, and no deductible is deducted from the compensation calculation.

Injuries to healthy trial participants are covered by both the Patient Compensation Association and the Occupational Injuries Insurance. Compensation from the Occupational Injuries Insurance generally takes precedence.

4. Investigators Responsibility

The trial responsible (investigator) should also consider whether they are sufficiently covered concerning personal liability, etc. At most locations, the Tech Trans units can provide guidance on insurance-related questions.

If an investigator-initiated drug trial involves an agreement with centers or trial sites located outside Denmark, consideration must be given to whether additional insurance should be taken out in accordance with GCP (Good Clinical Practice) rules. This insurance would cover trial participants participating in the study who might get injured as a result of participating in the trial. If such additional insurance needs to be taken out, it is the responsibility of the research institution to do so, and they must bear the cost.

Find information about Denmark's patient insurance scheme and the compensation scheme for medicinal injuries

Last updated 01-02-2024
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