The ordinances on a joint HTA has been used from January 12, 2025 and is directly used in all EU countries, exactly Regulation 2021/2282. However, the Polish government, however, only on Tuesday adopted a draft amendment to the Act on reimbursement of medicines, foods for special nutritional uses and medical devices, as well as the Act on healthcare services financed from public funds, which adapts Polish right to the EU regulation. The main changes are:
1. Giving up the need for re -clinical analysis
Applicant for reimbursement He will not have to present a full clinical analysis if identical data – In this indication, target population and scope – have already been assessed at the EU level and meet national requirements.
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2
Poland will be obliged to join the national HTA ratings Reports from joint clinical assessments published on the EU platformboth for completed grades and in progress.
3. New tasks of the medical technology and tariff assessment agency
Medical Technology and Tariff Assessment Agency (AOTMIT) will receive additional tasks resulting from the EU regulation, it is mainly about participation in the work of the EU coordination group regarding HTA. Tasks for Aotmit are provided for in the amendment to the Act on healthcare services. As a result, employment in the agency will increase, first by 10 full -time jobs from January 2026.
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4. Reduction of procedural requirements
The project assumes reduction of formal requirements when submitting applications for reimbursement and setting the net pricewhich will speed up the procedures and facilitate the introduction of new technologies into the healthcare system.
The new regulations are to come into force 14 days from the date of announcement. However, the proceedings regarding refund applications initiated and not completed before the date of entry into force will be considered on the basis of existing provisions.
