The large amendment to Poland’s Reimbursement Act (Duża Nowelizacja Ustawy Refundacyjnej, DNUR) finally came into legal force on November 1, although a small number of its regulations will only come into force in 2024 and 2025. It is the most significant amendment to the Reimbursement Act since it became law in 2012. The DNUR took over two years from the publication of its initial draft to reach the stage of ratification and entry into law. It is not the first ‘large’ amendment to be drafted, although previous ones were shelved before reaching parliament. The Reimbursement Act laid the foundations for Poland’s current pricing and reimbursement system, introducing price negotiations with the Economic Commission, and establishing the systematic evaluation of medicines by the Agency for Health Technology Assessment and Tariff System (AOTMiT), as the central elements of reimbursement procedures. The DNUR, by contrast, has no particular headline measures and instead features novelties and adjustments across a broad range of areas. Some of the most important of these are outlined below: The gold standard of business intelligence. Almost as significant as the measures included in the act are those that have been discarded during the very long consultation process. Plans for a price corridor, which would have seen drugs priced more than 50% above the reference price excluded from reimbursement, were abandoned, as were plans to introduce a new definitive willingness-to-pay threshold of six times the average GDP per capita per quality-adjusted life year (QALY). The removal of these proposals has helped to reduce the overall negative impact of the DNUR. However, there is no shortage of remaining measures that are controversial for the industry. There are significant uncertainties surrounding the new definition of “reimbursement confidentiality,” and the potential impact the abovementioned exemptions may have on the confidentiality of prices after negotiations. Removing the requirement to gain the consent of manufacturers of drugs already included in drug programs when changes to the programs are made is expected to speed up access to new medicines, but there are concerns that the MoH may make changes that have unfavourable financial consequences for manufacturers, which they then have no chance to challenge. The decision to introduce reimbursement for certain OTCs has been met with bewilderment; when Poland continues to lag behind many of its EU partners in access to originator drugs, many have questioned why reimbursing OTCs should be seen as a priority. Industry lobbyists have predicted that imposing price controls on OTCs will damage Polish manufacturers and benefit producers from low-cost markets. Even changes that can be regarded as more favourable, at least to a section of the industry, such as the introduction of incentives for manufacturers investing in production in Poland, have received criticism, for not going far enough; similar responses have been seen in other European countries that have sought to introduce new regulations to strengthen supply security in the face of drug shortages. Offering manufacturers 10–15% lower co-payments for manufacturing their finished drugs and/or APIs in Poland is not expected to provide much relief. Over the past couple of years, the outgoing government of the Law and Justice Party has overseen a significant advancement in terms of access to new medicines, particularly oncology and orphan drugs. The DNUR, however, does little to advance this cause. It will be for the new government, expected to be formed of a coalition dominated by the centre-right Civic Coalition, to define the next phase in Poland’s drug policy. Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge. Thank you! Your download email will arrive shortly We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form The gold standard of business intelligence.