DNUR 2.0: in anticipation of the next amendment to the drug reimbursement law

Nevertheless, we already know the assumptions of the future draft amendment to the Reimbursement Act, which were presented by the Department of Drug Policy and Pharmacy at the Ministry of Health at a meeting with representatives of applicants held on July 15 this year. From the information presented at the time, it appears that another major amendment to the Reimbursement Law is being prepared, and therefore another DNUR. Among the issues to be covered by the amendments to the legislation were listed:

- reimbursement of drugs for rare diseases - the Health Ministry has announced a change in its approach to reimbursement of such products, including the introduction of multi-criteria analysis as an additional criterion for evaluating reimbursement applications for these drugs;

- Withdrawal of the possibility introduced by DNUR to include selected OTC drugs in reimbursement; instead of reimbursing OTC drugs, the Health Ministry proposes a new procedure for reimbursement applications - at the call of the Health Minister;

- changing the rules regarding the mandatory reduction in the price of a reimbursed drug after the expiration of market exclusivity - the Health Ministry is proposing to introduce the principle of the so-called rolling reduction - the mandatory reduction in the price of a drug (which can still be realized at both the official price and the effective price) would be realized from the first time the drug is covered by reimbursement until the expiration of market exclusivity; however, it is planned to move away from the proposal to realize such a reduction at the expiration of patent protection;

- Changes to supply declarations and liability for failure to meet declared supply volumes; among other things, the Health Ministry announces that it will remove from Article 25 of the Reimbursement Law the algorithm introduced by DNUR to determine the minimum level of declared supplies, which has been shown to often lead to erroneous declarations that are not in line with reality;

- Removal from the Reimbursement Law of provisions providing for mandatory discontinuation of reimbursement proceedings at the stage of analysis of applications by AOTMiT;

- The introduction of a new reimbursement availability category in the Reimbursement Law, which would apply to drugs used in AOS for non-oncological diseases;

- A faster reimbursement path for foreign-language packaging of drugs already reimbursed;

- Introducing the tenure of members of the Economic Commission and their certification;

... as well as a number of other more or less specific changes.

The proposals presented by the Ministry of Health sound interesting in many points; it is apparent that the authors of the draft amendment do not limit themselves to the technical removal of perceived errors in the Act, but want to treat the amendment more broadly, as an opportunity to streamline reimbursement processes and improve the reimbursement system. However, in order to achieve this effect of the amendment, specific legislative solutions should be consulted in the course of work on the amendment with representatives of the pharmaceutical market, whose perspective is important for assessing the practical usefulness of the new regulations being introduced; especially since it is on the business decisions of these entrepreneurs (whether or not to apply for reimbursement) that the extent to which the amended law will improve the availability of reimbursed drug therapies in Poland largely depends.

And the fact that improving a bad law should not always be about making it more restrictive is evidenced by the example of the changes introduced by DNUR, concerning liability for failure to keep the continuity of supply and the declaration of supply of reimbursed drugs. Among other things, Article 34(2) of the Reimbursement Law was amended last year, which regulates in which cases an applicant is financially liable for failing to meet its obligation to ensure the continuity of supply of a reimbursed drug. Safeguarding patients' needs, i.e. the circumstance that patients' needs for treatment for a given condition have been met despite reduced supplies of a reimbursed product, was removed from the catalog of premises whose occurrence exempts an entrepreneur from financial penalties.

The result? Applicants have radically reduced the volumes of supplies declared in their applications, as the Health Ministry itself now points out, in a communiqué published on the Ministry's website on August 22 this year. The results of the analysis of reimbursement applications submitted under the so-called "big renewal" (i.e., the planned continuation of reimbursement for most reimbursed products from January 1, 2025), presented in the communiqué, show that some applicants have reduced their supply declarations even by more than half. And in my opinion, this is not due, contrary to the assessment presented in the communiqué, to the market-favorable interpretation of the flawed regulations governing supply volumes, which was also announced earlier by the MZ communiqué, but precisely to the tightening of the provision on liability for failure to meet these supplies, i.e. the amendment to Article 34 of the Act. This is because, with the prospect of a higher risk of incurring financial penalties than before in the event of making deliveries of drugs smaller than declared, most applicants will want to approach their declarations cautiously and declare smaller quantities of reimbursed drugs than the deliveries they will realistically be able to make. Therefore, paradoxically, a change that was supposed to improve the availability of reimbursed drugs could potentially lead to a worsening of their availability.

May the SNUR, or rather the next DNUR, be an opportunity for the legislature to take seriously the consultation of the created law with the social side, so that the new legislation works well in practice, not just in theory.

Author: Katarzyna Czyzewska

Czyzewscy Kancelaria Adwokacka