Poland has moved a planned reform of individual medicine reimbursement into pre-consultation and parliamentary scrutiny. The Ministry of Health (Ministerstwo Zdrowia, MZ) draft covers Rescue Access to Drug Technologies (Ratunkowy Dostęp do Technologii Lekowych, RDTL), target import and a new compassionate-use route, with most provisions proposed from 1 January 2029.
At a 29 July meeting of the Parliamentary Team for Polish Medicines Sovereignty (Parlamentarny Zespół ds. Suwerenności Lekowej Polski), Mateusz Oczkowski, director of MZ’s Department of Drug Policy and Pharmacy, said RDTL was increasingly being used for prolonged treatment without the price negotiation that accompanies standard reimbursement. The draft would make the mechanism more explicitly transitional.
RDTL authorisations would remain limited to three months, with continuation linked to demonstrated clinical benefit. A new three-person hospital RDTL committee would assess treatment initiation and continuation, alongside specialist-consultant input and financial approval by the National Health Fund (Narodowy Fundusz Zdrowia, NFZ).
The draft would also replace the current expenditure control with manufacturer paybacks once annual RDTL spending on an active substance in an indication exceeds PLN2 million. Proposed repayment rates are 10% on expenditure between PLN2 million and PLN4 million, 20% between PLN4 million and PLN8 million and 30% above PLN8 million. Additional repayments would apply where RDTL financing continues beyond 12 months.
The wider framework would introduce a statutory compassionate-use route and more digital administration of individual access. Stakeholders have questioned whether additional approval stages could delay treatment and whether manufacturer liabilities are proportionate.
MZ said pre-consultation would continue until mid-September before publication and formal legislative processing. If retained, the measures would make exceptional access a more structured bridge towards standard reimbursement, with financial pressure increasing as use becomes broader or longer-term.
Source: Sejm of the Republic of Poland
Link: Parlamentarny Zespół ds. Suwerenności Lekowej Polski – Posiedzenia (Parliamentary Team for Polish Medicines Sovereignty – Meetings)
Date: 29 July 2026
Source: Cowzdrowiu.pl
Link: Refundacja indywidualna: co jest w projekcie? Od kiedy zmiany? (Individual reimbursement: what is in the draft? When will the changes start?)
Date: 1 July 2026
Source: Menedżer Zdrowia
Link: Szykują się zmiany w ratunkowym dostępie do technologii lekowych. Są już pierwsze krytyczne opinie (Changes are coming to rescue access to drug technologies. First critical opinions have already emerged)
Date: 29 July 2026
