Streamlined reimbursement law looks to boost medicine access in Poland
Published on 7th Feb 2025
What can Poland's pharmaceutical industry expect from further reforms due in the second quarter of this year?
The Polish government has listed a bill amending the Act on Reimbursement of Medicines, Foodstuffs for Special Nutritional Purposes and Medical Devices, as well as other acts, on its recently published legislative work agenda.
In the media discussion following the listing on 25 January, the changes have been referred to as the "quick amendment" of the Reimbursement Act.
The amendment, which is the initiative of the newly appointed government, aims to revise the solutions introduced to the act in 2023, as well as introduce new mechanisms to optimise the procedures and ensure access to reimbursed medicines.
Despite its description as "quick”, the planned date for adoption of the project by the Council of Ministers is the second quarter of 2025.
Who is affected?
The description of the objectives of the project and the outline of the planned solutions it follows indicate that the changes will affect all participants in the reimbursement system.
These include companies applying for reimbursement, parallel importers, wholesalers, pharmacies, authorities in the reimbursement proceedings (the Minister of Health, the Economic Commission and the President of the National Health Fund), IT service providers, patients and patient organisations, and others.
Revisions and reversals
The proposal repeals the controversial formula that determines the volume of supply to be guaranteed by the applicant and abolishes the requirement to supply a variety of scarce products to the 10 largest pharmaceutical wholesalers. The requirement has now been overturned by a non-binding communication from the Minister of Health.
The possibility of reimbursing over-the-counter medicines will also be removed.
The prohibition to modify the reimbursement application after the resolution of the Economic Commission will be repealed, extending the possibility for additional negotiations with the Minister of Health. Meanwhile, the regulation of reimbursement secrecy will be modified and limited to the risk-sharing schemes.
Provisions linking patent protection and regulatory market exclusivity to certain reimbursement conditions will be repealed, while the enforcement of penalties for breaches of continuity and volume of supply obligations will be facilitated.
New solutions
The Minister of Health will be able to call for a reimbursement application if patients' needs require it. In return, the summoned company will receive administrative preferences.
The legislation will simply the application for reimbursement of parallel imported medicinal products will be simplified, and a new reimbursement availability category for medicines for non-oncological diseases in specialist outpatient care will be introduced. The reimbursement procedure will take into account the specificities of orphan drugs (used for rare diseases); in particular, by regulating the use of multi-criteria analysis.
Provisions will be introduced to regulate the transferability of a reimbursement decision to another entity in the situation of a marketing authorisation transfer. The reimbursement pathway for new indications of already reimbursed medicines, as well as regulatory requirements for new uses of known substances, will also be made simpler.
Osborne Clarke comment
Stakeholder in the pharmaceutical industry should monitor the developments of the legislative works and can submit comments during the public consultations on the bill. Within the next six-months, consider adjusting internal policies based on a legal review in order to avoid administrative enforcement for non-compliance.
You can contact Osborne Clarke for horizon scanning advice. For more information, please subscribe to Osborne Clarke Life Sciences Academy or connect with our Polish Life Sciences team.
