SNUR: assumptions to the draft amendment of the Reimbursement Act

The SNUR (as the amendment is called), according to the information disclosed in the list, would be adopted by the Council of Ministers in the 2nd quarter of 2025, and it seems that it could be an even more extensive and comprehensive amendment to the provisions of the Reimbursement Act than the DNUR adopted in 2023. This is because the information contained in the list of legislative and programmatic work of the Council of Ministers on the solutions to be introduced by this law counts as many as 52 points. Most of the changes indicated in it concern issues that were previously announced by the Ministry of Health, such as:

• The abolition of the requirement to submit in the application for reimbursement a declaration of future supplies in accordance with the formula that is currently regulated by the law - as the algorithm has been found to be flawed and to lead to incorrectly established declarations of supplies;
• Removal from the law of the provision on the obligation to supply scarce drugs in equal quantities to the 10 largest full-line wholesalers - this provision has proven to be unworkable in practice;
• Reinstating the obligation to reduce the net selling price by 25 percentage points only on the expiration of market exclusivity, and not on the expiration of a drug's patent, given the sometimes very complicated patent protection regimes that apply to individual products;
• Introducing a mechanism for a rolling reduction in the net selling price upon loss of market exclusivity for a drug - all prior reductions in the net selling price, starting from the first decision to include the drug in reimbursement, will be counted toward the mandatory 25 percentage point reduction;
• Reinstating the ban on reimbursement for drugs in the OTC availability category;
• Introducing a simplified reimbursement procedure for parallel imported drugs, including exempting applicants for these drugs from price negotiations;
• Moving the point at which proof of the market availability of the drug covered by the reimbursement application is required, almost to the end of the proceedings, to the moment after the publication in the SOLR of the positive decision of the Minister of Health, that is, just before the reimbursement decision is issued;
• Introducing a definition of "orphan drug" and a definition of "multi-criteria analysis" into the reimbursement law, as well as changes to the reimbursement procedure for such drugs;
• Introduction of a new reimbursement availability category for drugs for non-oncology indications, which will be able to be transferred from drug programs to reimbursement within the framework of Ambulatory Specialized Care; it will also be possible to apply for coverage of a drug in this reimbursement availability category;
• Adding provisions to the Reimbursement Law on the need for applicants to ensure availability to patients for drug therapies under new drug programs from the first day of the reimbursement decision, with the provision of a financial and billing mechanism until the implementation of the program in question is contracted by the National Health Fund under risk-sharing instruments;
• Amending the rules for imposing penalties on applicants for failing to fulfill supply declarations or failing to ensure the continued supply of a reimbursable drug.

However, the description of the draft amendments to the Reimbursement Law, which is published in the list of legislative and programmatic work of the Council of Ministers, is not limited to a mere repetition of information that was already presented by the Ministry of Health last year. Indeed, some of the changes are described in more detail. For example, during a meeting with representatives of the pharmaceutical industry last July, the Health Ministry announced changes to Article 34 of the Reimbursement Law, concerning the imposition of penalties on applicants who fail to meet their commitment to continuity of supply or annual volume of supply, but little else was known about what the new rules for applicants' liability on this account would be. Information published on January 20 of this year on the website of the Prime Minister's Office of the Council of Ministers indicates that penalties would be imposed by the President of the National Health Fund automatically, based on data collected in the Integrated System for Monitoring Trade in Medicinal Products. At the same time, applicants are to be granted access to the ZSMOPL (to the extent, of course, of the stock of drugs belonging to a given responsible entity), which will allow verification of the correctness and accuracy of the data collected in the System.

In addition, there are several new proposals in the description of the future law amending the Reimbursement Law; for example, there are the following changes:

• Raising the lower wholesale margin limit to 80 cents (from the current 50 cents);
• Amendments to Article 13a of the Reimbursement Law, concerning economic and administrative preferences in reimbursement for drugs manufactured in Poland and/or from active substances manufactured in Poland;
• Limiting the total time of suspension of reimbursement proceedings at the stage of preparation of the verification analysis, to a total of 45 days (last year it was announced that it would be 60 days), and indicating that in the event that the President of AOTMiT assesses that the condition he placed in the conditional recommendation has not been met, the President's recommendation from conditional will change to negative;
• An amendment to Article 13(6a) of the Reimbursement Law to add a stipulation that, in the case of re-reimbursement, the net selling price cannot be higher than the CZN in effect for that drug on the date of application - but for the indication in question;
• Introducing a provision preventing applications for reimbursement of a drug in a drug program when the drug or its equivalent is already reimbursed in open (pharmacy) reimbursement, as well as in the reverse situation;
• An amendment to Article 9(1) of the Reimbursement Law to clarify that healthcare providers are required to purchase reimbursed drugs at no more than the gross wholesale price;
• Introducing the possibility of changing the limit group for a drug that does not have this group established in the reimbursement decision.

How extensive and accurate is the description of the future law, published in the list of legislative and programmatic works of the Council of Ministers, allows us to assume that the draft SZNUR is already ready or almost ready. There is a chance, therefore, that it will soon go to external consultations and we will learn the details of the solutions proposed by the Health Ministry.

Author: attorney Katarzyna Czyzewska

Czyzewski law firm