Reimbursement in Poland — What's changing?

Practical Next Steps for Your Business

Given the breadth and complexity of the planned amendments, we recommend that companies active in or planning to enter the Polish reimbursement market take the following steps without delay:

• Audit your current and pipeline reimbursement applications in light of the new
  provisions. In particular, assess how the revised 25% exclusivity-loss reduction mechanism, the new effective price definition, and the amended supply declaration model will affect your existing reimbursement decisions and any applications currently in progress.
• Review your OTC portfolio. If any of your reimbursed products are at risk of a category switch to OTC, or if they already have OTC equivalents on the market, you should assess your exposure to the proposed exclusion rules and consider appropriate mitigating action — including timing of applications and product strategy.
• Prepare for the mandatory preliminary opinion requirement. For products without a
  reimbursed equivalent in the relevant indication, the pre-submission consultation process will
  become compulsory. Plan your reimbursement timelines accordingly and engage early, as the opinion binds you in the subsequent application.
• Consider the MCDA implications for orphan/rare disease products. Although the
  obligation will not apply until 2028, the guidelines from AOTMiT must be issued by June 2027. Companies with rare disease portfolios should begin building internal MCDA capability and monitoring the guidance process now.
• Assess your supply chain and manufacturing footprint. The Fenix project, the
  manufacturing preference mechanism, and the revised supply declaration framework all interact with the sourcing and production decisions you make today. If a transfer of manufacturing to Poland is commercially and operationally viable, the three-year decision framework may offer meaningful long-term stability.
• Engage with the legislative process. The draft is still subject to public consultation and
  parliamentary debate. There is scope for the provisions to be amended before enactment — and industry input has historically influenced the final shape of Polish reimbursement legislation. We encourage clients to engage with industry associations and to respond to consultation processes where relevant.

Key Amendments Planned Under the Draft Amendment to the Reimbursement Act

The PPO President formally transmitted a comprehensive review of accession conditions to the Minister of Justice the first structured inter-institutional engagement on this topic in over 15 years. The review has since been shared with the Ministry of Economic Development and Technology, and a trilateral ministerial meeting has been requested, marking the beginning of active cross-ministerial consultations.

The timing is further reinforced by the ongoing legislative review of the Unitary Patent Regulations at EU level in 2026, making this a strategically significant moment for Poland to assess its position.

Poland as a Strategic Market

Poland is one of the largest pharmaceutical markets in Central and Eastern Europe, with a population of approximately 38 million and a publicly funded healthcare system that serves as the primary access route for patients. Reimbursement status is, in practice, the prerequisite for meaningful market penetration, as nonreimbursed medicines remain largely inaccessible to most patients due to high out-of-pocket costs. Poland also carries reference pricing implications beyond its borders.

The net selling price agreed in Polish negotiations may be used as a reference point in international price comparison exercises, including under existing national IRP systems across the region. How you structure your offer in Poland can therefore directly affect your pricing position elsewhere in Europe.

Finally, the draft's push to incentivise local manufacturing creates a concrete regulatory rationale for companies reviewing their supply chain footprint, positioning Poland as an increasingly attractive production hub within the EU.

1. Statutory Definition of Effective Price

The draft introduces, for the first time, a statutory definition of effective price - understood as the actual cost borne by the public payer, taking into account confidential risk-sharing instruments. Critically, only instruments that directly and unambiguously affect the per-package or per-patient treatment cost will be considered in the calculation. Under the current act, where the per-package or per-patient price is reduced through a risk-sharing instrument, the effective price in subsequent reimbursement decisions may not exceed that established in the previous decision.

2. MCDA for Orphan Drugs

The draft adds statutory definitions of orphan medicinal products and Multi-Criteria Decision Analysis (MCDA). MCDA will become a mandatory additional element of the reimbursement dossier for orphan drugs used in rare diseases. The Agency for Health Technology Assessment and Tarification (AOTMiT) will be required to issue MCDA guidelines by 30 June 2027, with the obligation applying to applications submitted from 2028 onwards.

3. Limits for High-Cost Pharmacy Therapies

The rules governing reimbursement of high-cost therapies dispensed in pharmacies will be amended. For certain pharmacy-access therapies, the Minister of Health will be able to specify, in the reimbursement announcement, the number of reimbursed packages or the duration of therapy. Reimbursement decisions and announcements may also include additional information, such as ICD codes, where these have been established for a given indication.

3. Supply Declarations Returning to a Negotiation-Based Model

The draft moves away from the current formula for calculating minimum supply volumes. Supply continuity and volume declarations will once again be subject to negotiation. The reimbursement decision will continue to specify the commitment to supply continuity and annual supply volumes broken down by month, where applicable. The Economic Commission will assess supply levels differently depending on the product's status: already reimbursed products, generic equivalents, and products without a reimbursed equivalent in the same indication will each be treated differently.

5. Revised 25% Price Reduction Mechanism after Loss of Market Exclusivity

The rules on the 25% price reduction applicable upon expiry of market exclusivity will be significantly restructured. The reference point for the reduction will be the first day of the first reimbursement decision - not the last decision prior to expiry of exclusivity. The draft allows the obligation to be met in various ways: through the net selling price, the effective price, a hybrid solution, or an additional risk-sharing instrument. However, for pharmacy-access products, fulfilment through a risk-sharing instrument will be excluded.

6. New Rules for Generic Equivalents

The threshold price mechanism for generic equivalents will be clarified. The draft confirms the one-off nature of the first-equivalent condition and clarifies threshold price-setting rules in multi-molecule limit groups. A new presentation of an already reimbursed product in a given indication will not be treated as a further equivalent; the reference point will be the cost of the cheapest presentation of that product already included in the reimbursement list. 

7. Preferences for Medicines Manufactured in Poland

The draft retains and reinforces preferences for medicinal products manufactured in Poland or using an active substance produced in Poland. Patient co-payments are reduced by 10% for products manufactured in Poland or using an active substance produced in Poland, and by 15% where both the product and the active substance are manufactured in Poland, with the cost of the reduction financed by the National Health Fund (NFZ). Decisions relating to the transfer of manufacturing to Polish territory will be issued for a period of three years, and a repayment mechanism to NFZ will apply in the event of non-fulfilment of the manufacturing transfer commitment.

8. OTC Medicines - Exclusion from Reimbursement

The draft fundamentally changes the approach to OTC products. Over-the-counter medicines (i.e., those dispensed without a prescription) will be excluded from reimbursement. In addition, a reimbursement decision may be revoked if a prescription-reimbursed product switches to OTC status. Reimbursement of a prescription drug that has an OTC equivalent will also be excluded, save for clinical situations where treatment is required for longer than 30 days.

9. Mandatory Preliminary Opinion Prior to Application

A new requirement for mandatory pre-submission consultation will be introduced for products that have no reimbursed equivalent in the relevant indication. The Minister's preliminary opinion will cover the reimbursement access category and the scope of the benefit, and — for drug programmes — the content of the programme description. The opinion will be valid for one year, and applicants will be bound by its content when subsequently lodging the formal application.

10. Changes to Drug Programmes

The rules governing drug programmes will be amended in several respects. A drug for which a new programme is being created and which has no reimbursed equivalent in the indication may be provisionally included in the reimbursement list before the reimbursement decision takes effect. The draft also adjusts the rules for reviewing drug programme descriptions and introduces the possibility for a patient organisation representative to attend meetings of coordinating teams — without voting rights. The NFZ has raised concerns about data protection and organisational disruption in connection with patient representative participation at sessions where individual
patient cases are discussed.

11. Economic Commission - Composition and Procedure

The Economic Commission will receive additional tasks and revised organisational rules. The draft introduces knowledge and experience requirements for candidates, term limits for Commission members, and removes the mandatory participation of an NFZ President's representative in every negotiating team. Currently, the Commission conducts negotiations in a three-member team, with an NFZ representative required in each team.

Under the new rules, applicants will be permitted to be represented by up to four persons in negotiations, or five where they choose to include a patient organisation representative.

12. Greater Flexibility to Amend Applications Post-Negotiation

The draft clarifies the rules on modifying a reimbursement application after the Economic Commission has adopted its resolution. After the Commission's resolution, the applicant may not change the net selling price or the risk-sharing instrument. However, other elements of the application will be capable of amendment during the proceedings — a notable improvement in procedural flexibility.

13. Later Submission of Proof of Market Availability

Applicants will gain the ability to submit proof of market availability of the product at a later stage — specifically, no later than the date of issue of the reimbursement decision. For advanced therapy medicinal products (ATMPs), a commitment to ensuring technological readiness for manufacturing on the date of application must be provided.

14. Fast-Track Procedure for Foreign-Language Packaging

A special procedure will be introduced for medicines in foreign-language packaging or with foreign-language package leaflets. The procedure applies to products already included in the reimbursement list and in the relevant announcement issued under pharmaceutical law. The application will be exempt from a portion of the standard formal requirements, from price negotiations, and from a separate supply commitment. Financial conditions under this route may not be more favourable than those in the most recent decision for the same product in Polish language packaging.

15. The "Fenix Project" for Generics

The draft introduces the so-called Fenix project mechanism. Where no more than four generic equivalents are reimbursed in a given indication and reimbursement access category, the Minister of Health will be able to invite the marketing authorisation holder of a generic product to submit a reimbursement application. In such cases, the applicant will be exempt from the obligation to meet the threshold price otherwise applicable to generic equivalents under the Reimbursement Act.

16. Simplifications for Combination Products

For combination products (fixed-dose combinations) reimbursed in pharmacies, where their single-substance equivalents are financed within the same indication scope, the draft provides for a waiver of the obligation to submit full HTA analyses and an exemption from the HTA verification fee.

17. Pharmacy Compounding - New Limits and Definitions

In the area of pharmacy compounding, the draft introduces a definition of compounding utensils (utensylia recepturowe), a list of reimbursable utensils, financing limits, and an official wholesale margin for raw materials, utensils, and finished medicinal products used as raw materials. A compounding formulary for publicly funded compounded medicines will also be established.

Where a formulary is defined for a given field of medicine, only compounded medicines included in that list will be eligible for reimbursement. The NFZ has proposed narrowing the definition of compounding utensils to direct packaging only, to avoid undue expansion of compounding
medicine costs.

18. Higher Minimum Wholesale Margin

The minimum wholesale margin will be raised from PLN 0.50 to PLN 0.80. A statutory wholesale margin of 6% of the purchase price will apply to pharmaceutical raw materials, compounding utensils, and finished medicinal products that may be treated as pharmaceutical raw materials. Currently, the statutory wholesale margin stands at 6% of the net selling price, subject to a minimum of PLN 0.50.

19. Supply Obligation Penalties - ZSMOPL - Based Enforcement

An important change concerns the sanctions for failure to meet supply obligations. Penalties will be imposed only where patient needs have not been met — and the burden of proof that needs were satisfied through other reimbursed products will rest with the applicant. Penalties will be imposed by the President of the NFZ on the basis of data from the Integrated System for Monitoring the Trade in Medicinal Products (ZSMOPL). The NFZ has queried certain aspects of the drafting and raised concerns about duplication of functions already performed under the pharmaceutical law monitoring framework.

20. Product Returns After Loss of Reimbursement

The draft clarifies the rules on the return of products that have lost reimbursement status. Pharmacies will be able to demand a refund of the purchase price for products acquired no earlier than nine months before the change in the announcement; wholesalers will have a corresponding right in respect of products acquired up to twelve months before the change.

21. Reimbursement Announcement Divided into Three Parts

The reimbursement announcement (obwieszczenie refundacyjne) will be restructured into three sections corresponding to the three reimbursement access categories: pharmacy reimbursement, drug programmes, and chemotherapy. The announcement will contain additional data, including retail price, ICD codes, number of packages, or duration of therapy, where specified. For chemotherapy, an annex describing reimbursed indications will be added.

22. SWDPL System and Drug Programme Monitoring

The draft provides for the establishment of a new Drug Policy Decision Support System (SWDPL), which will be used by the Economic Commission in the course of negotiations, including for working with reimbursement reports and simulations. It also introduces revised rules for the electronic drug programme monitoring system. ZSMOPL data will be made available to the NFZ for the purpose of verifying compliance with supply obligations, among
other things. The NFZ has flagged concerns about the feasibility of the twelve-month timeline for migrating and adapting over 130 drug programme registers to the new system.

23. Phased Entry Into Force 

The Act is due to enter into force on 1 January 2027 as the general date, with the following exceptions:

Download as PDF.