1 November 2023 marked the entry into force of the largest amendment to the Polish Act on the Reimbursement (Amendment) since it came into force in 2012. As reported in this blog, the Commission’s Proposal to reform the EU General Pharmaceutical legislation includes a measure whereby marketing authorisation holders (MAHs) would be expected to ensure patient access in all the EU Member States within two (or in exceptional cases, three) years as of obtaining a marketing authorisation (MA), in order to keep the exclusivity period at the currently applicable level (i.e. eight years). Consequently, any local regulations potentially influencing market access are of great interest to pharmaceutical companies.
The Amendment has been widely criticised by experts and the pharmaceutical industry as not only failing to make changes beneficial to patients and the industry but even as negatively affecting the functioning of the reimbursement system in Poland.
The Act on Reimbursement (Act) is the key legal instrument regulating the financing of medicinal products, foodstuffs for special dietary purposes and medical devices in Poland. At the time of its introduction into the legal system in 2012, the Act was intended to provide a greater degree of transparency into reimbursement activities and to open up the reimbursement system to new innovative products while also rationalising public spending on these products. Its main objective was to transform the existing system so that, with the public financial resources available, it responded as fully as possible to current social demand for reimbursed products.
More than 10 years after its entry into force, it became apparent that the Act required changes in certain areas, especially given the fact that to date it has not been amended to any significant degree.
Although almost one month has passed since the entry into force of the Amendment, the Minister of Health (MoH) has unfortunately not yet answered a number of open questions. The proper interpretation of – as yet unclear – regulations is important, as some of them are expected to adversely affect the operations of the pharmaceutical industry. The most important regulations expected to have a negative impact on the functioning of the Polish pharmaceutical market are the following:
- allowing the MoH to exercise manual control in certain areas, including changes in the drug program descriptions and qualifications to a given limited group of similar products during the term of the reimbursement decision, posing a risk to the stability and certainty of administrative decisions;
- establishing – somewhat incomprehensible – supply obligations, which could detract from Poland as a market when companies are weighing up their international launch strategy for new products;
- significantly changing the process of creating drug programs (used for the most expensive products, including orphan and oncology medicinal products) and an increased role for coordinating teams in the treatment process, which could discourage pharmaceutical companies from reimbursing medicinal products in Poland (unless it turns out that this is unavoidable due to the evolution of the EU Pharma Package regulations);
- increasing the role of the Polish HTA Agency in the reimbursement process in a potentially unpredictable way;
- introducing changes to the current confidentiality rules by setting up grounds for the broader exchange of data, and limiting the scope of data and information being subject to redaction on the HTA assessment level.
It is apparent that the vaguer the new regulations are, the greater the doubts regarding the stability of industry operations in Poland. Especially in light of the potential upcoming changes to the EU pharmaceutical legislation increasing the role of product launch in each Member State. We continue to watch the interplay between such national regimes and the proposed EU reforms very carefully.
For a detailed summary of the regulations introduced by the Amendment click here.