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Katarzyna Czyzewska

Amendments to the reimbursement law: chaos in the transition period

MedExpress Team

Katarzyna Czyżewska

Published Nov. 28, 2023 18:00

Amendments to the reimbursement law: chaos in the transition period - Header image
Fot. Marcin Petruszka
Given that the legislative process for a major amendment to the Law on Reimbursement of Medicines, Foodstuffs for Special Dietary Purposes and Medical Devices took a long time (it took more than 2 years from the publication of the first draft to the enactment of the law), the entry of DNUR into force should not have come as a surprise to anyone. In fact, it could have been expected that everyone involved: pharmaceutical entrepreneurs, doctors, MZ and NFZ officials, and finally patients would be perfectly prepared for the changes. And yet, after the first few weeks of the law's changes, it's hard to resist the impression that there is chaos in the transition period between the old and the new legal order. Why? Mainly because the application of the new rules to reimbursement proceedings initiated before November 1 is quite selective and not always consistent with the transitional provisions of the Act amending the Reimbursement Act.

Theoretically, the rules for the transitional period are clear: according to Article 8 of the Act of August 17 of this year amending the Act on Reimbursement of Medicines, Foodstuffs for Special Dietary Purposes and Medical Devices, as well as some other acts, the current provisions apply to reimbursement proceedings initiated and not completed before the effective date of the amending act. The only exceptions to this are the provisions of Article 11 of the Reimbursement Act (regarding coverage or denial of product coverage and the content of the reimbursement decision), and Article 31a(3a) of the Act, according to which Article 98 of the Code of Administrative Procedure (on suspending administrative proceedings at the request of a party) does not apply to reimbursement proceedings. In practice, however, some of the new provisions are already being applied to proceedings initiated before the DNUR came into force, while the application of others is deferred.

An example of the changes to the Reimbursement Law, which are now being put into practice even...

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