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Focus on Regulation

Poland: New Medical Research Agency

On Monday, March 4, the President signed a bill on the establishment of a new institution, the Medical Research Agency (ABM).

The new Agency will be a specialized body of experts who will work on innovation in Polish medicine, focusing on areas related to oncology, haematology and rare diseases. The activities of the Agency will primarily consist in co-financing scientific research and development work as well as interdisciplinary projects, with particular emphasis on clinical, observational and epidemiological research. Moreover, the Agency will be able to initiate and carry out its own scientific research and development work and, additionally, to expand international cooperation.

According to the Ministry of Health, the Agency’s main area of interest will be non-commercial clinical trials of medicinal products and medical devices of all phases that constitute currently only around 1% of the total number of clinical trials. Non-commercial studies have not so far been financed by the pharmaceutical companies. However, they are considered equally important as they prove or verify the effectiveness of medicinal products and medical technologies.

The Agency will be managed by the President of the ABM appointed in for a term of 6 years by the Minister of Health and by the Agency’s Scientific Council.

The Agency’s budget in 2019 will amount to approximately PLN 50 million, and in 2028 it is expected to be around PLN 1 billion. The body will be financed by the state budget and a write-off from the National Health Fund (NFZ) in the amount of 0.3% of its revenues. However, the money from the NFZ write-off will be used only for non-commercial clinical studies. The Agency may also be financed from other sources, such as donations, the EU budget, international research programmes or ABM’s business activity in the area of publishing or commercialisation of scientific research results.

The establishment of the Agency is expected to provide institutional support for the financing of analyses and scientific research in health care and contribute to the growth of innovation in Polish medicine. According to the Ministry of Health, the first research competitions are to be announced in the second half of this year.