Medicinal products intended for immunization
The amendment introduces a special reimbursement procedure for certain selected vaccines, particularly those that are non-mandatory.
Participants in the proceedings will newly include not only marketing authorization holders and health insurance companies, but also the Czech Medical Association of J. E. Purkyně.
For the purpose of determining the amount and conditions of reimbursement, the State Institute for Drug Control (Institute) will assess vaccines with regard to medical, social, economic, and ethical aspects, as well as their impact on public health.
The
Institute’s assessment report will newly include a statement from the National
Institute of Public Health, which is issued after the initiation of the
procedure and may differ from the Institute’s own position.
As in the
case of orphan medicines, the assessment report will be reviewed by the
advisory body of the Ministry of Health in a non-public session, during
which a conciliation procedure will take place.
The Institute will then issue a decision in accordance with the binding opinion of the Ministry of Health, which may, among other things, differ from the original proposal of the assessment report — for example, in the amount or conditions of reimbursement.
The amendment abandons the “economically least demanding variant” (ENNV) regime for vaccines, which previously favored older vaccines at the expense of modern ones. Vaccines that are already reimbursed will retain their current reimbursement after the amendment, with the possibility of individual changes in selected cases.
In brief: the amendment
On 12 August 2025, the amendment to the Act on Public Health Insurance was promulgated in the Collection of Laws as No. 289/2025 Coll. Its general effective date is 1 January 2026, with selected provisions taking effect during 2026 or in subsequent years.
The amendment proposes substantial changes to the regulation of public health insurance. In the area of pricing and reimbursement of medicinal products, it will affect, for example: the process of external price referencing (EPR), the rules on deemed availability, the definition of Highly Innovative Medicinal Products (VILP), proceedings on reimbursement for VILPs and orphan medicinal products (LPVOs) used in combination, contractual commitments with payers, assessment of a product as an LPVO, similar medicinal products, lis pendens (litispendence), the submission of models, and review (revision) proceedings.
The reimbursement mechanism will also change—especially for vaccines and monoclonal antibodies intended for prophylaxis—and a special procedure for immunization medicines will be introduced.
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The text was translated using ChatGPT 5.