POLAND Law and Practice Contributed by: Marcin Tomasik, Tomasz Jaworski, Filip Gołba and Jakub Matusiak, Tomasik Jaworski Sp.p.
If both of these conditions are met, the payment is reduced by 15%. In addition, a broad category of products are available in pharmacies free of charge to senior citizens (65+), minors (18-) and pregnant women. Medical devices are publicly funded in several ways. • Prescribed medical devices available in pharma- cies are covered by the Minister of Health’s reim- bursement decisions and published in its reim- bursement list. This category consists of devices that do not require personalisation for every patient – eg, diagnostic strips for blood glucose monitoring and special types of dressings. The pricing of this device group is regulated under the same statu- tory official price/margin framework as reimbursed medicines. • Medical devices supplied on the instructions of an authorised healthcare professional are included in the Minister of Health’s regulation, which indicates, for example, the device’s public fund financing limit, the patient’s own share in the limit and the criteria on which devices are granted. There are no negotiation procedures; conditions apply to every device and are set formally. This group consists of devices that require personalisation (eg, infusion sets for a personal insulin pump, lenses, prosthe- ses, adult diapers and wheelchairs). • Medical devices provided in an inpatient setting are financed from the public fund as part of the medi- cal procedure and are supplied to patients free of charge. These devices are procured by hospitals and clinics in public procurements. 8.4 Cost-Benefit Analyses Health technology assessment (including clinical and/ or economic evidence and budget impact) is a core component of the reimbursement process, with the scope of required analyses depending on whether there is a reimbursed equivalent in the given indica- tion, among other factors. The reimbursement deci- sion has to be made on the basis of scientific evi- dence. The applicant marketing authorisation holder has to prove the product’s cost-effectiveness com- pared to the alternative therapeutic substance that is already reimbursed from public funds. The Agency
for Health Technology Assessment and its advisory body, the Transparency Council, play a crucial role in the assessment process. As of 16 February 2026, Poland continues to use the statutory cost-effectiveness threshold expressed as three times GDP per capita. The current published value is PLN244,821 per quality-adjusted life year. The Minister of Health issues an individual adminis- trative decision on the reimbursement of a product, taking into account the statutory criteria for setting the net selling prices and reimbursement conditions, including: • the stance of the Economic Commission; • the recommendations of the President of the Agency for Health Technology Assessment and Tariff System (AOTMiT); • the significance of the clinical condition to which the reimbursement application relates; • clinical and practical efficacy; • safety; • the relationship between health benefits and administration risk; • the cost to health effects ratio of the previously reimbursed products compared to that covered by the application; • price competitiveness; • the impact on the expenses of the entity obliged to finance healthcare services from public funds and on service recipients; • the existence of alternative medical technology and its clinical efficacy and safety; • the map of health needs developed by the Minister to identify priority health needs and challenges for the organisation of the healthcare system and to ensure sustainable and co-ordinated spending of public funds; • the threshold cost of gaining an additional quality- adjusted life year; and
• commitment to continuity of supply. 8.5 Regulation of Prescriptions and Dispensing by Pharmacies
While dispensing reimbursed medicinal products, medical devices or foodstuffs intended for particu- lar nutritional uses, pharmacy staff (pharmacists and
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