The Act is the key legal instrument regulating the principles by which the Republic of Poland finances the use of medicinal products, foodstuffs for special dietary purposes and medical devices to patients. At the time of its introduction into the legal system, the Act was intended to introduce a greater degree of transparency in the reimbursement activities of public authorities as well as to open up the reimbursement system to new innovative products while also rationalizing public spending on these products. Its main objective was to transform the existing system so that, with the public financial resources available, it responds as fully as possible to current social demand for reimbursed products. It became apparent that the Act required changes in certain areas more than 10 years after its entry into force and during which time it was not amended to any significant degree.
In the summary of the Amendment (also referred to as its justification) the Minister of Health (MoH) maintained that it will, for example, ensure: (i) a stable level of funding for reimbursed products; (ii) enhance efficient use of public funds to achieve optimal health effects; (iii) the systematic expansion of the reimbursed therapies with proven efficacy available; (iv) optimization of the reimbursement system for medicinal products that are not yet regulated by the Act; (v) a systematic reduction in patient contributions to financing reimbursed products; (vi) greater transparency of reimbursement decisions and more trust in dialogue; (vii) a reduction in bureaucracy in certain areas and (viii) an increase in what is termed the “medicinal safety of Poland”, i.e. the set of benefits awarded to pharmaceutical companies manufacturing products and/or active pharmaceutical ingredients (API) in Poland.
Unfortunately, experts’ predictions are not so optimistic. Indeed, there are a couple of positive changes but in the main the Amendment is expected to negatively impact the pharmaceutical industry and, contrary to what the MoH believes, the situation of patients. Among other things, the Amendment introduces regulations: (i) allowing the MoH to exercise manual control in certain areas, which might have an impact on the stability and certainty of administrative decisions (which is a general rule); (ii) establishing incomprehensible supply obligations; (iii) significantly changing the process of creating drug programs (used for the most expensive products, including orphan and oncology medicinal products) and an increased role of coordinating teams in the treatment process.
Please find below a brief summary of the most important amendments proposed by the MoH. Please note that, except for certain amendments that will come into force on a different date (as indicated in this document), the Amendment comes in force on 1 November 2023.
Sections starting with “Former” refer to the previous wording of the Act, valid until 1 November 2023, whereas those starting with “Amendment” summarize the changes introduced in the Amendment, starting from 1 November 2023 (except for certain exceptions where the new regulations come into force later).
“Rating” refers to our subjective assessment of a particular change proposed in the Amendment from the point of view of the pharmaceutical industry.
"Hint" refers to an unofficial interpretation of the MoH, presented during workshops for marketing authorization holders (MAH) and their representatives, organized by the MoH on 18 October 2023.
Click here to access the full alert.