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.
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.
As part of a new article series, we will briefly highlight the main areas that will change under the amendment to the Act on Public Health Insurance, effective 1 January 2026.
