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» jesteś tutaj: » NASZE USŁUGI » Clinical trials insurance

Clinical trials insurance

This is one of our main specializations.

We arranged the first policy of this type in May 2002 and up to now we have insured over 140 clinical trials.

We have arranged polices for clinical trials run in Argentina, Czech Republic, Denmark, Moldova, Romania and Bulgaria.

None of the policies we have arranged were rejected by bioethical committees, CEBK or URPL.

The amendment to the Polish pharmaceutical law related to Directive 2001/20 / EC of the European Parliament caused far-reaching changes in the clinical trial insurance market in Poland.
Both tests of medicinal products and medical devices are covered by the insurance obligation on conditions not worse than those specified in the relevant regulations of the Minister of Finance. It is worth noting that both regulations impose minimum sums insured/ limits depending on the number of participants in the study.

The main problem of compulsory third party liability insurance of a researcher and sponsor in Poland is the construction of the insurance itself. It was created as a normal third party liability insurance. The result is that the insurance primarily protects the insured - the perpetrator of the damage, from its financial consequences - claims of the aggrieved party. Participants / patients are not directly insured in any way.

Insurance cover is granted on the basis of generally binding civil law (Article 415 of the Civil Code). This means that the damage must be culpable by the insured.

As a result, the effect is that there might be no protection for damages caused by, for example, an adverse effect described in the patient information the risk of which the patient has accepted by signing the ICF. His consent simply excludes the fault of the insured (sponsor and investigator), and thus their liability, which results in the lack of the insurer's obligation to indemnify.

The second impediment is the need for the injured person to prove the damage caused by the insured's actions, which stems from the provisions of art. 6 of Polish Civil Code, and that for many reasons (eg the state of the victim) is difficult.

Although the compulsory insurance is arranged, the participant still carries a significant risk of participating in the study.

Therefore, we recommend to our clients to additionally arrange a non-fault liabillity insurance, which provides insurance coverage in the event of damages for which the investigator or sponsor is not culpable. In this insurance, the participant is entitled to compensation as a result of his injury or damage to his health in connection with the study, and the insurer may not refuse to pay compensation, calling that the Insured's was dilligent or the participant consented to the risk of adverse effects by signing the ICF.