Will the draft of a major amendment to the Reimbursement Act come into effect?

It seems that work on the draft of a major amendment to the Reimbursement Law may soon accelerate, as a new version of the draft amendment to the Reimbursement Law (dated March 28 this year) was published on the Government Legislation Center's website on the last day of March, along with an excerpt from Memorandum of Understanding No. 1/2023 of the meeting of the Standing Committee of the Council of Ministers on January 5, 2023. The MOU shows that the draft amendment to the Reimbursement Law was approved by the SKRM (with an auto-amendment and amendments, as discussed below), and the Standing Committee of the Council of Ministers recommended it to the Council of Ministers. This means that the draft may soon be officially adopted by the Council of Ministers and referred to the Diet.

A comparison of the versions of the draft amendments to the Reimbursement Law - the most recent and last year's - may give the impression that a great many changes have been made to the draft; however, these are mostly editorial or language changes, with no substantive significance. Among the changes of importance to applicants, it is worth mentioning the removal from the draft of Article 13b of the Reimbursement Law, in light of which the Minister of Health could order the applicant to return within 14 days all benefits, obtained by virtue of the preferences granted to him in the reimbursement decision, by virtue of applying for reimbursement of a drug manufactured in Poland. In addition, the legislature dropped the addition of another controversial provision to the law, Article 40(1b), which stipulated that the responsible entity, by obtaining reimbursement for a drug in an off-label indication, assumed full responsibility for adverse reactions to that drug in the uses covered by the decision. This was a debatable solution, since off-label reimbursement is not granted at the request of a party, but ex officio, and thus does not even require the consent of the responsible entity. The latest draft amendment to the Reimbursement Law also did not include the previously proposed Article 11(12) of the Law, according to which the Minister of Health would be obliged to refuse to issue a reimbursement decision if the threshold amount of the cost of an additional quality-adjusted life year exceeds six times per capita GDP in a given case, or, if this cost cannot be determined, the cost of an additional life year. This is a significant positive change, as the provision deleted from the draft would prevent many much-needed but expensive drugs from being covered by reimbursement.

Unfortunately, the list of good news is not very long, as most of the unfavorable changes in the draft amendment to the Reimbursement Act were left in place. We are talking, among other things, about changes in the procedure for applying for reimbursement coverage of a drug. The draft still provides for, among other things, the prohibition of modifying the reimbursement application (including the price) after the Economic Commission has issued a resolution, the exclusion of the application to reimbursement proceedings of a provision of the Administrative Procedure Code allowing the suspension of proceedings at the request of a party, and finally the particularly controversial idea of subjecting persons signing reimbursement applications on behalf of applicants to criminal liability as for making false statements in the event that the data, information or documents attached to the application turn out to be false. Slight changes have also been made to the provisions of Articles 11(3a) and 13(2) of the Reimbursement Law, criticized by part of the community, concerning mandatory price reduction after the expiration of the protective period for a drug. Although the legislator has waived the requirement to apply this reduction after the expiration of the protection period resulting from the supplementary protection certificate, the obligation to reduce the price by a minimum of 25% is still to apply in the event of the expiration of market exclusivity and patent protection; and it is not explicitly indicated in the regulations that only in one of these cases. In addition, both the nominal (official) price of the drug and the effective price, resulting from the terms of the risk-sharing instrument, are to be reduced. The draft's authors further maintain their intention to exclude the possibility of increasing the official sales price before the expiration of the protection periods, as well as within 12 months after their expiration.

Counsel Katarzyna Czyzewska