As of 1 January 2026, an amendment to the Public Health Insurance Act has entered into force, introducing, among other changes, new rules for determining the prices of strategically important medicines. The aim is to prevent supply shortages in the Czech Republic through a more flexible approach to setting maximum prices.
For medicinal products deemed to be in the public interest, the State Institute for Drug Control (the Institute) now determines the maximum price based on:
· the average of prices in up to seven of the lowest-priced countries within the EU reference basket;
· if the medicinal product is not available in at least two reference basket countries, prices are compared across the entire EU, or alternatively against therapeutically comparable medicines in the Czech Republic or within the reference basket.
To prevent Czech prices from being driven down by isolated price anomalies, the Institute applies a number of exclusion rules:
· if the lowest price in the EU is more than 20% lower than the average of the second and third lowest prices, it is excluded from the calculation;
· prices from countries experiencing significant currency depreciation are excluded where three or more reference prices are available;
· prices distorted by government crisis interventions in other countries are disregarded, provided that the Institute has received official information about such measures.
The Institute has already issued a number of decisions establishing maximum prices for strategically important medicines. However, a concerning trend can be observed in its decision-making practice. Although this “special regime” is intended to enhance market stability, many decisions lack sufficiently detailed reasoning clearly demonstrating that the statutory conditions for applying this approach have been met.
The new framework provides the state with a powerful tool for safeguarding the availability of medicines. Its effectiveness, however, will depend on the transparency and reviewability of decisions, ensuring that marketing authorisation holders clearly understand how and why the final price was determined.
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Articles on decision-making practice are based on publicly available texts from the decisions of the Ministry of Health of the Czech Republic and the State Institute for Drug Control (SÚKL).
A continuously updated overview of decisions issued by SÚKL and the Ministry of Health in the field of pricing and reimbursement is available on the Pharmeca a.s. website.
The text was translated using ChatGPT 5.3