The Polish government has published a draft bill to amend the Reimbursement Act and related legislation. The current version of the Projekt ustawy o zmianie ustawy o refundacji leków, środków spożywczych specjalnego przeznaczenia żywieniowego oraz wyrobów medycznych oraz niektórych innych ustaw (Draft act amending the act on the reimbursement of medicines, foodstuffs intended for particular nutritional uses and medical devices and certain other acts) was published on the Prime Minister’s legislative register on 5 March 2026 as version 2.0 of project UD187. The government presents the bill as a response to concerns raised by companies, patients and other stakeholders, and as a way to simplify procedures and improve access to reimbursed products.
The draft proposes several changes to the reimbursement process. It would remove the formula-based supply declaration requirement introduced in 2023 and instead leave the agreed supply volume to negotiation. It would also remove the rule requiring shortage products to be distributed equally through the ten largest pharmaceutical wholesalers, which the explanatory text says has proved difficult to apply in practice.
The bill would also introduce mandatory pre-submission consultations before certain reimbursement applications are filed. According to the explanatory text, this is intended to improve the quality of applications and reduce the need for later corrections. The draft would also simplify procedures for shortening the period of validity of a reimbursement decision, change the timing rules for official price reductions. It would also narrow the scope of reimbursement confidentiality. According to the explanatory text, the current confidentiality provision is too broad and makes it difficult to inform the public about reimbursement proceedings. The government therefore proposes to limit confidentiality under Article 30b to the processing of risk-sharing instruments, while also clarifying which parties are bound by confidentiality and the rules on sharing information about concluded risk-sharing arrangements..
Another proposed change concerns health technology assessment material. The bill would remove the current one-year validity limit for HTA analyses. The government argues that this rule has created unnecessary procedural burdens and that removing it should make the reimbursement process more flexible.
The draft also includes provisions intended to support local manufacture and supply security. The explanatory text links some of the proposed changes to the aim of strengthening the availability of reimbursed products and improving the resilience of the domestic supply chain. This is relevant because it shows reimbursement policy continuing to be used not only as a coverage tool, but also as part of a wider supply policy.
The bill is still at draft stage and must go through the legislative process. If adopted, it would make a number of procedural changes to reimbursement administration in Poland, particularly in relation to supply obligations, pre-submission engagement, confidentiality and price-setting procedure.
Source: Prime Minister’s legislative register
Link: Projekt ustawy o zmianie ustawy o refundacji leków, środków spożywczych specjalnego przeznaczenia żywieniowego oraz wyrobów medycznych oraz niektórych innych ustaw (Draft act amending the act on the reimbursement of medicines, foodstuffs intended for particular nutritional uses and medical devices and certain other acts) — https://www.gov.pl/web/premier/projekt-ustawy-o-zmianie-ustawy-o-refundacji-lekow-srodkow-spozywczych-specjalnego-przeznaczenia-zywieniowego-oraz-wyrobow-medycznych-oraz-niektorych-innych-ustaw6
Date: 5 March 2026
