POLAND Law and Practice Contributed by: Marcin Tomasik, Tomasz Jaworski, Filip Gołba and Jakub Matusiak, Tomasik Jaworski Sp.p.
Poland is also a member of the World Trade Organi- zation (WTO) and the Organisation for Economic Co- operation and Development (OECD). Following the aggression of the Russian Federation against Ukraine in 2022, sanctions have been imposed on the import and export of certain goods to and from Russia and Belarus. Poland applies EU sanctions and has also adopted a national law that allows the appli- cation of further sanctions on Polish entities and their related companies that deal with Russian/Belarussian entities that support the aggression. The trading of pharmaceuticals and medical devices has not been expressly excluded from these national regulations. Sanctions compliance is counterparty- and goods- specific. While pharmaceuticals/medical devices are not typically the primary target category, restrictions may apply depending on the sanctioned person/entity, financing/logistics and export-control classifications. 8. Pharmaceutical and Medical Device Pricing and Reimbursement 8.1 Price Control for Pharmaceuticals and Medical Devices As a rule, statutory price control applies to products covered by a reimbursement decision (reimbursed medicines, certain medical devices and foodstuffs intended for particular nutritional uses); the prices of non-reimbursed products are generally market-based. Key pieces of legislation in this respect are the Act of 12 May 2011 on the Reimbursement of Medicines, Foodstuffs Intended for Particular Nutritional Uses and Medical Devices and the Act of 27 August 2004 on the Healthcare Services Financed from Public Funds. In accordance with the former, the following products may be publicly reimbursed: • medicinal products, medical devices and food- stuffs intended for particular nutritional uses that are reimbursed in the “pharmacy” category (dis- pensed in pharmacies); • medicinal products and foodstuffs intended for particular nutritional uses available within a drug programme; • medicinal products available within chemotherapy; and
• medicinal products, medical devices and food- stuffs intended for particular nutritional uses avail- able for use within the provision of publicly funded services other than those listed above. If a product is reimbursed, its price is fixed by the reimbursement decision and reflected in the ministe- rial reimbursement announcement ( obwieszczenie ). For reimbursed products, official prices and margins are fixed (in particular, the official retail price must be applied in pharmacies). Official prices are uniform nationwide. The official wholesale margin is 6% of the official net selling price, with statutory caps (in particular, a cap of PLN150 for products reimbursed in pharmacies, and PLN2,000 for products reimbursed in drug programmes/chemotherapy). The official retail margin is calculated according to statutory rules (price brackets) and depends, inter alia, on the limit base in the relevant limit group. For providers (hospitals/clin- ics) purchasing reimbursed products to deliver pub- licly financed guaranteed services, the Reimburse- ment Act sets maximum purchase prices linked to the official net selling price plus no more than the official wholesale margin. For a product to be publicly reimbursed, the marketing authorisation holder has to apply for inclusion in the public reimbursement system. The 2023 amendment of the Reimbursement Act envisages special incentives for products manufac- tured in Poland. Available preferences include expe- dited processing of the application, exemption from price negotiations with the Economic Commission or a prolonged term of reimbursement. Official net sell- ing prices and other reimbursement conditions are set by an individual decision of the Minister of Health. Negotiations with the Economic Commission are a key element of the process in practice. The decisions are then reflected in the ministerial reimbursement announcement ( obwieszczenie ), which specifies reim- bursement categories, co-payment levels and official prices, among other matters. Medicinal products, medical devices or foodstuffs intended for particular nutritional uses are assigned to reimbursement limit groups (internal reference pric- ing). Medicines with the same international name or
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