POLAND Trends and Developments Contributed by: Marta Sroka-Maleta, Andrzej Siwiec, Katarzyna Kroner and Maciej Adamczyk, DBS Law Firm
The life sciences sector is shaped by a rapidly evolv- ing and increasingly complex legal landscape. Both upcoming legislative initiatives and those recently incorporated into Polish law aim to enhance the avail- ability of therapies, streamline administrative and clini- cal procedures, and ensure alignment with EU regula- tions and case law. Against this backdrop, companies operating under Polish jurisdiction face a number of developments that merit close attention. This article highlights the most relevant changes and emerging trends, including: • legislative work on amending the Polish Act on Reimbursement; • the CJEU ruling on pharmacy advertising and its consequences for the domestic pharmacy market; • trends in the medical device sector in Poland; • the deregulation of pharmaceutical laws; and • the implementation of the Joint Clinical Assess- ment in reimbursement decision making. Legislative Work on Amending the Polish Act on Reimbursement Following the adoption of the largest amendment to the Act on Reimbursement to date in August 2023, further substantial changes to the Polish reimburse- ment law are forthcoming. The need for another amendment to the Act was announced by the Ministry of Health in 2024, in response to industry criticism of the previous amendment. Based on the initial version of the draft published on 22 May 2025 and the latest announcements by the Ministry of Health, the expected amendment will lead to a significant shift in the legal landscape. The scale of the proposed changes resulted in nearly 600 com- ments being submitted to the original draft during public and ministerial consultations. The draft amendment therefore provides for the removal or far-reaching modification of various provi- sions introduced into the Polish reimbursement sys- tem in 2023. The most significant proposed changes included in the draft amendment to the Act on Reim- bursement are outlined briefly below. The algorithm used to calculate the volume of sup- ply declared by applicants for reimbursement is to be
removed, as it produced results that did not reflect market needs or manufacturers’ capabilities. Instead, supply volumes will be negotiated with the Economic Committee. The rules governing the financial liability of applicants who breach their obligations regarding the volume and continuity of supply are set to be amended. The regu- lations adopted in 2023 – the violation of which carried severe consequences for pharmaceutical companies – gave rise to numerous interpretative doubts. The proposed provisions are better aligned with mar- ket realities, particularly because applicants can be exempted from such liability if patients’ needs have been met by other equivalent reimbursed products. One of the most-discussed proposals is the introduc- tion of a new category of reimbursement availability, dedicated to medicines for non-oncological chronic diseases. These reimbursed medicines will be avail- able for use in specialistic outpatient care. Through this change, the Ministry of Health aims to exploit the potential of outpatient care and improve patient access to certain therapies that are currently reserved for use in hospitals. Instead of proving that the product has been available on the market on the application date, applicants will be able to submit a declaration confirming its avail- ability on the date the reimbursement decision enters into force. The current obligation has often delayed the entry of both innovative and generic products into the reimbursement system. The reimbursement decision is to be transferable to another entity (eg, a new marketing authorisation holder or its representative), provided the current addressee gives consent. This long-awaited change will facilitate processes related to the transfer of prod- uct rights. If a medicine is already reimbursed and listed as a shortage medicine, pharmaceutical companies will have access to a simplified procedure to obtain reim- bursement for its foreign-language packages, which have previously been approved by the regulatory authority.
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