President Karol Nawrocki on August 25, 2025, signed a law amending the regulations on reimbursement of medicines, foodstuffs for special nutritional purposes and medical devices, as well as the Law on Health Care Services. The amendment brings Polish law in line with EU regulations on health technology assessment, which take effect on January 12, 2025.
The President has signed an amendment to the Law on Reimbursement of Medicines and Medical Technologies. Poland aligns law with EU regulations
Published Aug. 26, 2025 06:55
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The amendment implements European Union law and ensures the application of Regulation (EU) 2021/2282 of the European Parliament and of the Council on health technology assessment.
The regulation, which has been in effect in member states since January 12, 2025, introduces uniform rules for the assessment of innovative medical technologies, including drugs and medical devices, at the Union-wide level.
The amendment introduces, among other things:
- definition of "optional technology " - as a medical procedure that is feasible for a specific clinical condition and indication, available in Poland on the date of application,
- the possibility to waive the submission of a clinical analysis when applying for reimbursement for a drug, medical device or foodstuff for special nutritional use, if the relevant data has already been submitted at the EU level,
- Obligation to take into account reports from the EU's joint clinical evaluation when determining the target population and conditions for the use of innovative therapies,
- Giving the Agency for Health Technology Assessment and Tarification (AOTMiT) new tasks related to collecting and sharing data and analysis within the EU system.
The law will take effect 14 days after promulgation.
Source: President.co.uk
