There is no legal basis in the Public Health Insurance Act for excluding a medicinal product from price referencing on the grounds that its price is a tender price, nor does any other legal provision allow such a procedure.
In administrative proceedings concerning the determination of price and reimbursement initiated from 1 January 2026, it is possible, beyond the previously existing options, to exclude the manufacturer price in an EU Member State where that state has introduced a market-wide measure affecting the manufacturer price of the medicinal product. In such cases, however, SÚKL must receive official information from the relevant foreign authority or from the Ministry of Health.
In the determination of the maximum manufacturer price, a foreign price is also excluded in cases where the lowest price deviates by more than 20% from the average of the second and third lowest prices, or where more than three prices are identified and the price associated with an exchange rate deviating by more than 10% from the average exchange rate over the previous six calendar quarters is excluded.
When determining the base reimbursement, a foreign price may also be excluded if it is at least 20% lower than the average of the second and third lowest prices. However, this rule does not apply to highly innovative and orphan medicinal products.
Are you interested in reading regular commentaries on decisions by Pharmeca a.s.? Feel free to contact us.
At Pharmeca, we help you navigate the complex landscape of pharmaceutical and medical device information. We also offer flexible services that can be tailored to your needs at any time.
Our market position and experience allow us to support you whenever you need expert guidance.
Our knowledge, your opportunity.
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 5.2.