On 12 August 2025, the amendment was published in the Collection of Laws as No. 289/2025 Coll. The general effective date is 1 January 2026, with certain provisions taking effect during 2026 or in subsequent years.
The amendment proposes substantial changes to the regulation of public health insurance. In pricing and reimbursement of medicinal products, it will affect, for example the process of referencing foreign prices, adjustments to the automatic availability rule, the definition of Highly Innovative Medicinal Products (VILP), procedures for reimbursement of VILPs and orphan medicinal products (LPVOs) used in combination, contractual commitments concluded with payers, assessment of a product as an LPVO, similar medicinal products, lis pendens (litispendence), submission of (pharmacoeconomic) models, and review (revision) proceedings. It also changes reimbursement mechanisms—especially for vaccines and monoclonal antibodies intended for prophylaxis—and introduces a special procedure for immunization medicines.
We will gradually cover the key areas impacted by the amendment in this series.
Maximum Price
Beyond the existing framework, a new procedure will be introduced for important, hard-to-substitute and typically low-cost groups of medicines.
The amendment also brings a special definition of the “closest therapeutically comparable product” for medicines where availability must be ensured.
A new method of recalculating the average exchange rate will apply in cases of exchange-rate volatility for products with fewer available manufacturer prices.
The Ministry of Health will be empowered to exclude foreign manufacturer prices from referencing where there are significant currency exchange-rate differences or other exceptional, relevant circumstances affecting medicinal product prices in an EU Member State.
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