The Institute initiated an ex officio abbreviated reimbursement review on the grounds of the entry of the first similar medicinal product into the reimbursement system, without undue delay after verifying that the product concerned had been placed on the Czech market.
However, one of the affected marketing authorisation holders appealed against the initiation of the proceedings, arguing that the entering product was not the first similar medicinal product and referring to earlier proceedings in which the newly entering product had not been assessed as similar.
The Ministry of Health (MoH) rejected this objection, stating that although in the referenced proceedings the assessed product and the reference (originator) product contained the same active substance, they differed in dosage, standardisation units and pharmaceutical forms. Moreover, although both products contained a standardised allergen extract, they were assessed against additional criteria—such as therapeutic indications or pharmacological properties—and on that basis were not considered similar.
In the present case, however, the MoH considers the medicinal product concerned to be a generic within the meaning of the Act on Medicinal Products. The products involved in the proceedings contain the same active substance and a comparable pharmaceutical form as the reference product, and the appellant repeatedly failed to demonstrate otherwise.
In the case under review, the conditions for initiating a review on the grounds of the entry of the first similar medicinal product were therefore met.
The MoH further notes that although, under the legislation applicable at the time, SÚKL could have initiated the proceedings earlier, the appellate authority considers the approach whereby SÚKL waited for the first actual supply of the medicinal product concerned to be appropriate and well justified. This prevented a reduction in reimbursement for similar products based on a first similar medicinal product that was not yet commercially available.
Pursuant to the amendment to the Public Health Insurance Act, in abbreviated reviews initiated after 1 January 2026, there is now an obligation to verify market availability at a minimum level of 5%, or 2% for ZÚLP.
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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 5.2.