As of 1 January 2021, amendments to the Act on the Professions of Doctor and Dentist and Certain Other Acts, of 16th July 2020, came into effect. The amendments introduced changes in the field of medical experiments (clinical trials involving medicinal products). According to Article 23c Paragraph 1, the entity carrying out a clinical trial is required to take out liability insurance: A medical experiment may be conducted after the entity conducting the medical experiment concludes a third party liability insurance contract for its participants and the person whose effects may be directly affected.
It is worth noting, the liability insurance discussed above is different from that stipulated in the Polish Pharmaceutical Act of 2001. Under the Pharmaceutical Act of 2001, the investigator and the sponsor are obliged to conclude a civil liability insurance agreement for damages resulting in bodily harm or death of the trial participant caused in connection with the conduct a clinical study. The scope of the insurance therefore covers the liability of the sponsor and the investigator.
Whether this approach to clinical trials will spread to other insurance markets in Europe remains to be seen, but these types of developments can have a massive impact on other insurance regulations in the region, as other countries may adopt similar legislation if they deem it necessary. Ensure you stay up-to-date with market-specific clinical trial regulations from Axco.