New price regulations of the Ministry of Health for 2026: What is changing and what to watch out for

As of 1 January 2026, new price regulations issued by the Ministry of Health of the Czech Republic will come into force, governing the prices of medicinal products, medical devices, and healthcare services. In addition to partial content-related changes, they also introduce a major systemic novelty with certain legal implications for regulated entities.

Price regulations newly classified as measures of a general nature

A key change is that price regulations are now classified as measures of a general nature. This means that:

• they are accompanied by a statement of reasons; and
• their lawfulness may be challenged in court by filing a motion for annulment.

This shift significantly strengthens the procedural position of regulated entities and opens up greater scope for effective legal protection against disproportionate price regulation.

Medicinal products[1]

Price regulation of medicinal products continues to focus primarily on reimbursed medicines (although, as before, certain non-reimbursed products also remain subject to regulation).

The core parameters of the system remain unchanged:

• the maximum markup remains the same; and
• the rules for its allocation between distributors and pharmacies are also preserved.

In the statement of reasons, the Ministry of Health explicitly mentions that the markup allocation model “has proven effective in practice”.

An important change is that the markup allocation rules will no longer apply to medicines intended exclusively for hospital use.

At the same time, changes are being made to the lists of ATC groups with a deregulated manufacturer price. In addition, a separate list of ATC groups is newly introduced to which the Czech regulator, State Institute for Drug Control, is to apply special rules for setting the maximum price, with a view to ensuring the continued availability of medicinal products.[2]

Medical devices[3]

Here as well, price regulation remains limited to reimbursed medical devices only. The fundamental parameters of the regulation remain unchanged – for example, the maximum year-on-year increase in the manufacturer price of 3%.

However, a new rule applies: the manufacturer price may not be increased in the year in which the medical device is first reimbursed from public health insurance.

Healthcare services[4]

Price regulation continues to apply, among other things, to non-reimbursed healthcare services. This regulation also applies to healthcare providers that do not have contracts with health insurance companies.

The Ministry of Health justifies the need for this regulation, among other reasons, as follows:
“Given the lack of expert medical knowledge, patients are typically unable to assess whether the offered price is reasonable in view of its individual components; however, their demand for healthcare is inelastic, driven more by their health condition than by the price of the service.”

A positive change is the new option allowing providers, when setting prices for a calendar year, to base them on the base prices of the previous year, provided those prices are not increased. These rules bring a certain degree of administrative simplification.

Practical implications and recommendations

The new price regulations have significant practical implications across the entire healthcare sector. In practice, the following steps are particularly recommended:

• review current price lists and ensure their compliance with the new price regulations;
• in the case of medicinal products, check the new lists of ATC groups and assess their impact on price regulation.

Given that the price regulations are now classified as measures of a general nature, the possibility of seeking their annulment before administrative courts is also open. This represents a major development in the protection of the rights of regulated entities.