One of the solutions proposed by the new bill on clinical trials is the establishment of a special guarantee fund – the Clinical Trials Participants Protection Fund.
The Guarantee Fund, established as a state special purpose fund, will pay benefits to research participants, and its administrator will be the Medical Research Agency.
In each case, the President of the Agency will appoint a commission consisting of medical and legal specialists to examine specific claims of patients. The commission will rule on the appropriateness of paying any benefit to a patient if the injury is likely to be related to the study regardless of fault.
In the current legal reality, the only way to obtain compensation for damages incurred in connection with participation in a clinical trial is to pursue a claim against an insurer or civil action, resulting in a negligible number of compensations paid.
Easier recovery of claims
At the same time, the amount of the benefit received is to be reduced by the amount received from the clinical trial insurance, if it was previously paid.
This will prevent a research participant from receiving double compensation – from the insurer and from the Fund at the same time.
Claim for a benefit
If, in the course of a clinical trial, bodily injury, health disorder or death has occurred, the clinical trial participant or relatives to whom the deceased participant had continuously provided subsistence as well as immediate family members of the deceased participant may apply to the Fund.
They request a determination as to whether the bodily injury or health disorder or death of the trial participant resulted from his or her participation in the trial.
The bill schedules the following benefit amounts for participation in a single clinical trial for a single participant:
- In case of infection, bodily injury or health disorder of the participant – PLN 100,000.
- In case of the participant’s death – PLN 300,000.
As in the case of compensation for medical events, the participant will not lose the right to seek compensation from the insurer or to take legal action.
This will be an additional means to obtain compensation without going to court and incurring excessive court costs. Therefore, a limited amount of benefits that can be obtained by the clinical trial participant has been adopted.
The exact amount of benefits will be specified in a regulation of the Minister of Health.
Financing of the fund
The revenues of the Fund will include, among others, contributions paid by sponsors prior to the commencement of clinical trials, payments from the state budget, and interest.
The contributions will be calculated for each application for a clinical trial permit and will be due on the date of submission of the application for the clinical trial permit