On Wednesday, December 14, the first reading of the act on clinical trials of medicinal products for human use took place in the Sejm. The statements of the representatives of the parliamentary clubs at the Sejm rostrum showed that the deputies unanimously considered this project to be expected and necessary, both from the perspective of clinical trial participants and the clinical trials market.
Act on clinical trials in the Sejm
Published Dec. 15, 2022 09:05
Deputies emphasized the pro-patient nature of the solutions contained in the draft act, which ensure an even higher level of protection for patients, and also enable more efficient compensation of possible adverse effects. According to the deputies, the bill provides patients with a protective umbrella by introducing the Clinical Trials Compensation Fund.
Attention was also drawn to the pro-development nature of the act, which, through harmonization and elimination of administrative and legal barriers, will contribute to increasing competitiveness and thus to increasing the number of clinical trials conducted in our country. Members pointed to the important role of clinical trials in the development of the domestic pharmaceutical market.
The parliamentarians drew attention to the need to process the project efficiently due to the remaining short period of the transition period for the implementation of national solutions complementary to the European Regulation 536/2014.
The need to adopt the project in question in the context of fulfilling one of the milestones of the National Reconstruction Program was clearly emphasized.
The role of the Supreme Bioethics Committee, which will guard the safety of clinical trial participants, was also highlighted.
The draft law adjusts Polish legislation to the European one, and its content, developed with a wide range of people, consolidates regulations, eliminating their dispersed nature and enables the application of Regulation (EU) No. 536/2014 of the European Parliament and of the Council of April 16, 2014, which creates a new starting clinical trials in Europe from January 31, 2023
Deputies across political divisions recognized the solutions contained in the draft act as beneficial for the development of the Polish health care system.
Source: ABM
