Zastosowanie produktu leczniczego terapii zaawansowanej - wyjątku szpitalnego a eksperyment leczniczy
The application of the advanced therapeutic medicinal product – hospital exemption and the therapeutic experiment

Summary/Abstract: The article presents considerations based on the regulations of EU and Polish law regarding the manufacture and use of advanced therapy medicinal products – hospital exemptions. The author discusses the EU source of the ATMP-HE regulation, its function and the purpose of introducing it into EU law, and then the relationship of this regulation to the Polish regulation on the therapeutic experiment. In the author's opinion, on the basis of the current legal status, there is no justification for the position according to which an advanced therapy medicinal product – hospital exemption is such a legally separate concept, or even a legal institution, that the national regulation does not apply to it. This is because this position is not only inconsistent with EU and national regulations, but also results in shifting to the patient the burden of risk of using this product without any control and responsibility. The author expressed the position that de lege lata the use of an advanced therapy medicinal product - hospital exemption should be qualified as a therapeutic experiment, to which the limits of admissibility of its performance also apply. The author presents the effects of recognizing the use of ATMP-HE as the therapeutic experiment and the effects of adopting a different position. In addition, the article contains considerations on the groundlessness of equating the use of ATMP-HE with off-label use and compassionate use. The author also formulated de lege ferenda postulates.

• Details
• Contents