Reimbursement for original medicinal products gradually decreases over time – it “erodes”. A key factor in this process is the entry of the first generic (Gx) or biosimilar (Bx) into the reimbursement system. This usually leads to a broad reduction in reimbursement across the entire reference group of products, including the original, by tens of percent.
But what if the Gx or Bx is not really available on the market? This is addressed by the new rules for reimbursement reviews, which are applicable from 1 January 2026.
Previously: Erosion of reimbursement even without actual availability of competing products
The previous regulation set the rule simply: The Czech regulator (the State Institute for Drug Control, known in Czech as “SÚKL”) was supposed to commence the reimbursement review “without delay” after the first Gx or Bx entered the reimbursement system. In other words, the mere fact of a reimbursement decision for Gx or Bx having been issued was sufficient – the regulator did not need to examine whether the product was actually available and whether it was supplied to the Czech market.
This could lead to a situation where a Gx or Bx entered the reimbursement system only “on paper” but was not actually on the market, and yet there was “generic erosion”, i.e. a reduction in reimbursement across the entire reference group.
From 1 January 2026: Reduction of reimbursement only after verification of actual trading
At present, the regulator can initiate a reimbursement review only when it verifies that the Gx or Bx is actually available on the market (Section 39b(8) of the Public Health Insurance Act).
For medicines dispensed on a patient prescription, a market share of at least 5% is required, while a market share of 2% is sufficient for hospital-supplied separately billed medicines. The rules for determining the market share are set out in Implementing Decree No. 376/2011 Sb. (Sections 13a and 13b).
Follow-up change: End of mandatory 12-month supply commitment
The above-described change is also associated with the revocation of the rule according to which the manufacturer of the first Gx/Bx was obliged to submit, together with the application for reimbursement, a commitment to supply the product on the Czech market for a period of 12 months (Section 15(6)(e) of the Public Health Insurance Act in force until 31 December 2025).
The explanatory memorandum explains that the 12-month commitment was in practice a barrier to market entry for Gx and Bx: “In view of the global unavailability of certain active pharmaceutical ingredients (APIs), however, the respective marketing authorisation holders are reluctant to enter into a written commitment to supply the Czech market if their medicinal product enters the reimbursement system as the first similar product, thereby exacerbating the unavailability of the relevant therapy.”
At the same time, the legislator considered that it made no sense to require this commitment when the actual availability of Gx/Bx on the market is now to be verified.
Why does it matter?
This is an important shift: the impacts of Gx and Bx entry on reimbursement are now conditional on market reality, not just a formal decision. In practice, this change should have the effect of delaying the onset of generic erosion: it will not occur before the Gx or Bx actually penetrates the market in measurable volume.
