Poland pharmaceutical industry and reimbursement

The pharmaceutical landscape in Poland involves complex regulatory and financial processes. The reimbursement of medications is determined through multi-stage assessments by authorities such as the Agency for Health Technology Assessment and Tariff System (AOTMiT), which evaluates treatment benefits against existing therapies and estimates budgetary impacts.

Simultaneously, the Medical Research Agency (ABM) is actively supporting domestic drug development. The agency has recommended approximately 77 million PLN in funding for six projects aimed at increasing supply security and creating cheaper therapeutic alternatives. These projects include the development of generic GLP-1 obesity treatments, asthma and lipid disorder medications, biosimilar antibodies for oncology, and radiopharmaceuticals for diagnostics.

In October 2026, the Polish government adopted a draft amendment to drug reimbursement regulations to improve treatment access, particularly for rare diseases, and to strengthen drug security. The reform introduces a legal definition for ‘orphan drugs’ and seeks to simplify procedures for importing medicinal products from abroad. To address challenges in evaluating therapies for small patient populations where large-scale clinical trials are difficult, the reform proposes the use of multi-criteria decision analysis. The new rules also aim to increase the involvement of patient representatives in decisions regarding therapy financing.

Specific reimbursement codes and subsidy limits for 2026 have been outlined for patients with cystic fibrosis and primary ciliary dyskinesia, covering various respiratory drainage devices and inhalers. Since January 2023, respiratory devices have been available to patients of all ages, including those under four years old.