Poland introduces reforms to drug reimbursement and medical device access

The Polish government has adopted a draft amendment to drug reimbursement regulations aimed at improving access to treatments, particularly for rare diseases, and strengthening drug security. The reform intends to simplify procedures for importing medicinal products from abroad and introduces the legal definition of an ‘orphan drug’ for diagnosing, preventing, or treating rare conditions.

To better evaluate therapies where large-scale clinical trials are difficult due to small patient populations, the reform proposes using multi-criteria decision analysis. Additionally, the new rules aim to increase the involvement of patient representatives in decisions regarding therapy financing.

For patients with cystic fibrosis and primary ciliary dyskinesia, specific reimbursement codes and subsidy limits for 2026 have been outlined. These include nebulizers, pneumatic inhalers, mesh inhalers, and various respiratory drainage devices. Since January 2023, respiratory devices are available to patients of all ages, including those under four years old.