Liability for damages incurred in connection with conducting a clinical trial – EU and Polish law

Publication date: February 27, 2024

Conducting a clinical trial does not relieve the investigator and sponsor from civil liability arising from the clinical trial, under Polish law provisions. The sponsor and the investigator are civilly liable for any damage caused to a clinical trial participant resulting from their actions or omissions. The above general principles of liability for damage arising in connection with conducting a clinical trial create a legal mechanism of liability and illegality of the act under the Polish Act of March 9, 2023 on clinical trials of medicinal products for human use (Journal of Laws, item 605).

The sponsor and the investigator for conducting a clinical trial are subject to mandatory civil liability insurance for damage caused in connection with conducting a clinical trial. In the case of a low-intervention clinical trial within the meaning of Art. 2 section 2 point 3 of Regulation 536/2014, the sponsor is not obliged to conclude a civil liability insurance contract for damage caused in connection with conducting a clinical trial. The sponsor should attach proof of insurance confirming the conclusion of a civil liability insurance contract to the application for authorization for a clinical trial. Civil liability insurance covers the civil liability of the researcher and sponsor for damage resulting from bodily injury, health impairment or death of a clinical trial participant during the period of insurance coverage, caused in connection with conducting a clinical trial.

However, it should be noted that under this legal act, in principle, civil liability insurance does not cover damage:

1) involving damage, destruction or loss of property;

2) resulting from the development of addiction of the participant in a clinical trial, if the possibility of addiction was presented in writing to the clinical trial participant at the commencement of the clinical trial;

3) directly or indirectly caused by or related to asbestos;

4) resulting in the obligation to pay contractual penalties;

5) resulting from hostilities, martial law, riots, as well as acts of terrorism.

An important condition is that the minimum guaranteed sum of civil liability insurance, in relation to one event and all events the consequences of which are covered by the civil liability insurance contract for damage caused in connection with conducting a clinical trial, depends on the number of participants in the clinical trial and is the equivalent in PLN to:

1) up to 50 people – EUR 2,000,000;

2) over 50 people – EUR 5,000,000.

The minimum guarantee sum is determined jointly in relation to the sponsor and all investigators participating in a given clinical trial.

In the event of bodily injury or health impairment as a result of participation in a clinical trial, the clinical trial participant is entitled to compensation. In the event of the death of a clinical trial participant as a result of participation in a clinical trial, the compensation benefit is payable to the non-separated spouse, first-degree relative, a person in a relationship of adoption and a person cohabiting with the participant. Compensation is not payable if bodily injury or health impairment or death of a clinical trial participant results from the natural course of the disease. The rates of the compensation benefit are determined by law, and when determining the amount of the compensation benefit, the following are taken into account:

1) bodily injury or health disorder of a clinical trial participant – the nature of the health consequences and the degree of symptoms resulting from the bodily injury or health disorder, including the burden of treatment, health damage and deterioration of the quality of life;

2) death of a clinical trial participant – being married at the time of the clinical trial participant’s death, being related, being in a relationship of adoption, being in cohabitation and the age of a deceased clinical trial participant.

The sponsor and the investigator bear civil liability for damage caused to a natural person who takes part in a clinical trial by taking the medicinal product or being in control group 3 (Article 39(2) of the Personal Data Protection Act). Civil liability covers damages resulting from the actions or omissions of the sponsor and the researcher or resulting from the actions or omissions of persons to whom the sponsor delegated tasks (Article 75 of Regulation No. 536/2014). The solutions provided for in the Clinical Trials Regulation are directly applicable and do not detract from the provisions of national and EU law regarding the civil and criminal liability of the sponsor or investigator (Article 95 of Regulation No. 536/2014). Conducting a clinical trial does not release the sponsor or researcher from civil liability arising from conducting a clinical trial, which is independent of liability for damage resulting from the provision of health services or unlawful omission to provide health services related to the medical activity conducted (Article 25 of the Act of April 15. 2011 on medical activities, Journal of Laws of 2022, item 633, as amended). Both the investigator and the sponsor, each separately, are liable for any damage caused to a clinical trial participant resulting from his or her actions or omissions. In order to assign civil liability, it is necessary to meet its classic conditions:

– damage,

– an event causing damage for which the law holds the person responsible, and

– cause and effect relationship between the event and the damage.

The investigator and the sponsor do not bear joint and several liability – the liability of the investigator and the sponsor is based on general principles (most often in the tort regime based on fault, pursuant to Article 415 of the Act of April 23, 1964 – Civil Code, Journal of Laws of 2022 item 1360, as amended).

A new solution introduced to the Act on Clinical Trials is the creation of a state specific fund to pay compensation in the event of bodily injury, health disorder or death of a clinical trial participant as a result of participation in a clinical trial. The compensation system excludes consequences resulting from the natural course of the disease. Pursuing compensation from the Clinical Trials Compensation Fund, established especially for this purpose, allows to obtain compensation faster and easier without the need to initiate court proceedings and incur the associated costs. However, the clinical trial participant retains the right to seek compensation from the insurer or to take legal action regarding the civil liability of the sponsor and the investigator. The choice of the administrative route for seeking compensation for damages incurred in connection with a clinical trial rests with the clinical trial participant. When applying for a payment from the Fund, there is no requirement to prove that the damage was the result of the culpable behavior of the investigator or sponsor. Under the previously applicable regulations, the only way to obtain compensation for damages incurred in connection with participation in a clinical trial was to pursue claims (based on the fault principle) from the insurer or to file a lawsuit, which resulted in a negligible number of compensation paid. The compensation benefit is reduced by the amount of compensation obtained from the sponsor or investigator responsible for the damage, including liability insurance. The Patient Ombudsman informs the sponsor and the investigator whose activities involve the application for the compensation benefit about the payment of the compensation benefit.