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In our last post on this subject (available at http://ipllectual.pl/pl/nowe-obowiazkowe-ubezpieczenie-udzial-maloletniego-i-przepisy-karne-omowienie-najwazniejszych-zmian-w-przeprowadzaniu-eksperymentow-medycznych/) we gave an overview of the most important changes to the law on conducting medical experiments introduced by amendments to the Medical Professions Act.
One of the main changes discussed was the duty of entities conducting medical experiments to conclude additional insurance agreements (Article 23c (1) of the Medical Professions Act, introduced by an amending act dated 16 July 2020). At that time, we highlighted the fact that the catalog of entities which are subject to the duty to conclude additional insurance agreements was unclear and could lead to a range of interpretation and, consequently, lead to uncertainty in the application of these provisions.
In the explanatory memorandum to the draft regulation implementing these provisions (i.e. the Regulation of the Minister of Finance, Funds and Regional Policy of 23 December 2020 concerning compulsory civil liability insurance of entities conducting medical experiments), the government indicates that approximately 18,600 medical entities providing both in- and out-patient health care services and insurance companies are among the entities affected by this regulation.
Since the amendments came into effect, different interpretations of the amended provisions have been put forward by sponsors, investigators, clinical trial sites, and lawyers providing advice on the drafting and negotiation of clinical trial agreements. Although Art. 37a (2) of the Pharmaceutical Law states that a clinical trial of a medicinal product is a medical experiment with a medicinal product performed on people, as defined by the Act of 5 December 1996 on Medical Professions, the exact relationship between these two acts is not entirely clear.
In light of the difficulty of interpreting these provisions, the Minister of Health published a statement on 15 February 2021 recognizing these difficulties (the statement is available at https://www.gov.pl/web/zdrowie/komunikat-ministra-zdrowia-w-sprawie-stosowania-rozporzadzenia-ministra-finansow-funduszy-i-polityki-regionalnej-z-dnia-23-grudnia-2020-r-w-sprawie-obowiazkowego-ubezpieczenia-odpowiedzialnosci-cywilnej-podmiotu-przeprowadzajacego-eksperyment-medyczny).
According to the Minister’s statement, the regulation in question applies to medical experiments as they are defined by the Medical Professions Act, i.e. therapeutic experiments or research experiments, with the exclusion of provisions specifying different principles or procedures for conducting clinical trials or genetic research. According to the statement, a medical experiment which is a clinical trial within the meaning of the Pharmaceutical Law is not subject to these provisions of the Medical Professions Act.
An analysis of the Minister’s statement leads to the conclusion that only Investigators and the Sponsors conducting clinical trials under the Pharmaceutical Law are under a duty to obtain civil liability insurance (this particular obligation is regulated under the Pharmaceutical Law).
As the Minister’s statement clarified, organizational units of universities, research institutes, and other therapeutic entities are to be understood as being entities conducting medical experiments as defined by the Medical Professions Act. Therefore these entities will be under a duty to conclude additional civil liability insurance in respect of the entity conducting the medical experiment itself under the amended Medical Professions Act.
It is worth pointing out that a statement by the Minister of Health is not a source of law nor is it a binding interpretation of the law. Nevertheless, it is highly likely that both the medical and insurance sectors will follow this interpretation as it is the main source of guidance on whether clinical trials are excluded from the application of Article 23c (1) of the Medical Professions Act. Therefore, in light of this statement, it is unlikely that other authorities would adopt a different approach.
However, due to the continuing discussions regarding the insurance of medical experiments, including the lack of a decisive resolution of this issue during the drafting of the act which introduced Article 23c § 1 to the Medical Professions Act and the limited effect of the statement of the Minister of Health in dispelling doubts in its interpretation, this issue should certainly continue to be monitored. This is due to the fact that Art. 58 (7) pt. 2 of the Medical Professions Act makes the performance of a medical experiment without the conclusion of an insurance agreement referred to in Art. 23c (1) a criminal offence, punishable by a fine of between PLN 1,000 and PLN 50,000.
We are still waiting for the publication of the draft of the Act on Clinical Trials, which will provide for separate and detailed regulations on clinical trials themselves. This act is expected to contain comprehensive regulations on the liability of Sponsors, Investigators, and Sites, as well as providing for a cohesive insurance framework for these entities in the context of clinical trials. The draft of this act is currently under consideration by the Council of Ministers, and its adoption is planned for the second quarter of 2021. This date will likely be postponed again, which, unfortunately, has happened several times already.