As of January 1, 2025, an amendment to Act No. 526/1990 Coll., on Prices, came into force, significantly altering the procedural rules for the price regulation of medical devices. While this amendment does not introduce new regulatory principles, it brings changes to the legal form and procedural safeguards.
Existing pricing regulations and decisions will now be replaced by so-called price decrees, which will take the form of measures of a general nature. This hybrid legal act combines the generality of legislation with the specificity of administrative decisions. A key feature of the new framework is the obligation to justify price decrees and the possibility of their review by the Minister of Health or in administrative courts. Unlike standard measures of a general nature, price decrees will not undergo formal discussion, public consultations, or commentary. However, the MoH has promised informal consultations with experts before issuance to ensure a transparent dialogue.
Competencies in price regulation remain unchanged, ensuring continuity for all stakeholders. The State Institute for Drug Control will continue to oversee price control and handle first-instance violations, while the MoH retains responsibility for regulation development and acts as the appellate body. Transitional provisions in the amendment ensure a smooth implementation. Existing pricing regulations will remain valid until the end of 2025, automatically gaining the status of price decrees. However, they will not be subject to review, and any annulment will only be possible through administrative courts.
While the amendment does not alter the substantive price regulation itself, it strengthens legal protection for affected parties, which is particularly important in the dynamic medical device market. Regulation continues to target situations of limited competition, extraordinary market conditions, or imbalances between sellers and buyers, especially in subsidized goods. A key factor remains reimbursement from public health insurance. Existing mechanisms, including the 3% year-on-year price increase for medical devices, will remain temporarily in place.
The year 2025 will reveal whether the new system proves effective in practice and how well the MoH fulfills its commitment to transparent collaboration with the expert community. Although the amendment does not introduce revolutionary changes, it modernizes the procedural framework for price regulation, enhances efficiency, and ensures greater legal certainty for all involved parties.
Author: Aneta Dostálová