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Exactly one year ago, the Ministry of Health of the Slovak Republic submitted for public consultation a draft decree intended to significantly change the rules for determining reimbursement of medicines from public health insurance. Although the document is technical in nature, it has attracted considerable attention. A total of 333 comments have been submitted and published within the consultation process, including 16 classified as substantial comments.

The main purpose of the proposed decree is to define the detailed methodology for calculating the multiplier of gross domestic product (GDP) per capita, which is used to determine the so-called threshold value of an assessed medicinal product. This value is a key factor in deciding whether a medicinal product will be reimbursed from public health insurance based on its cost-effectiveness.

The original expectation was that the decree would enter into force on 1 June 2025. However, the timeline has been delayed, as by 15 May 2026 the Ministry had only announced the start of the comment evaluation process.

Another draft proposal, concerning the pharmacoeconomic evaluation of medicinal products, has already completed the public consultation phase and is currently awaiting the Ministry’s assessment of the submitted comments.

The purpose of this proposal is to reduce the discount rate used in pharmacoeconomic evaluations from 5% to 3.7% per annum, following the proposed modification of the methodology for determining the cost-effectiveness threshold.

Here as well, 16 comments were submitted during the consultation process, including 5 substantial comments. The comments addressed not only the proposed level of the discount rate itself, but also the possibility of applying lower discount rates for technologies with long-term benefits.

Comments were also submitted by the Slovak Ministry of Finance, which fundamentally disagrees with the method used to assess the financial burden. According to the Ministry, the expected positive budget impact is not sufficiently transparent, and it is unclear to what extent this impact results specifically from the proposed change in the discount rate as opposed to other measures, such as the above-mentioned proposal concerning changes to medicinal product threshold values.
The interconnection between both draft proposals has also been highlighted by the Slovak Antimonopoly Office, which recommended withdrawing the proposal from the legislative process until broader professional consensus is reached within the wider framework of medicinal product categorisation.

We will continue monitoring the outcome of the consultation process and keep you informed.

The article is based on publicly available information relating to Slovak legislation.

The text was translated using ChatGPT 5.5. 

The amendment introduced a new type of reimbursement procedure for products intended for immunisation (vaccines), designed primarily for non-mandatory vaccination. As of 1 May 2026, according to information from the State Institute for Drug Control (the Institute), 10 administrative proceedings had been initiated and are currently at various stages of progress.

This type of procedure is intended to apply the principle of multi-criteria assessment, placing emphasis not only on economic but primarily on non-economic criteria reflecting broader societal needs and interests.
In addition to the standard reimbursement criteria (safety, efficacy and, in the case of vaccines, immunogenicity), the criteria assessed also include, for example:

• the severity of the disease targeted by the vaccine,
• the broader societal importance of prevention,
• the public health benefit, including increased herd immunity, prevention of threats to public health, and support for and improvement of population health,
• recommendations issued by professional societies and institutions.

A different approach also applies to budget impact, where a high budget impact may reflect high vaccination uptake, which is desirable in this context. Budget impact is therefore assessed as the difference between the costs of prevention and the costs of treatment, diagnostics and broader societal costs that would arise in the absence of immunisation.

The Institute’s assessment report will also include an opinion of the National Institute of Public Health (SZÚ). SZÚ has already provided opinions in the first two administrative proceedings, focusing in detail on the epidemiology of the diseases concerned. It also addresses the health, societal and economic impacts of the diseases and the extent to which these may be mitigated through vaccination. The opinion further includes a recommended time horizon for the budget impact analysis, taking into account the characteristics of the disease, as well as an overview of currently applicable vaccination recommendations.

As in the case of orphans, the assessment report will subsequently be reviewed by the advisory body of the Ministry of Health (MoH) during a closed session, in which a conciliation procedure will take place.

The subsequently issued binding opinion of the MoH will then be incorporated into the final decision issued by the Institute. 

Our knowledge, your opportunity.

The article is based on publicly available information concerning administrative proceedings conducted by SÚKL in the area of pricing and reimbursement.

The text was translated using ChatGPT 5.2.  

At the beginning of April, a draft amendment to the Act on the Regulation of Advertising and the Act on Medical Devices and In Vitro Diagnostic Medical Devices was circulated to Members of Parliament. Among other things, it focuses on advertising of selected sensitive commodities, including human medicinal products and medical devices.
The scope of the Act is not limited to B2C relationships, i.e. advertising directed at the general public, but also extends to B2B relationships, including advertising targeted at healthcare professionals and employees of healthcare providers.
The expected effective date of the amendment is 1 January 2027.

In the following article, we present selected areas of the proposal in relation to specific product categories.

Medicinal Products

The draft expands the definition of advertising, under which all forms of information, market research or incentives intended to promote prescribing, sale, dispensing or consumption will newly be considered advertising.

The amendment also sets out strict conditions under which patient programmes may be conducted so that they are not regarded as impermissible advertising.

Changes will also affect advertising targeted at healthcare professionals. Commercial representatives will newly be allowed to provide Summaries of Product Characteristics (SPC) and reimbursement information also in the form of a link to a source enabling remote access.

Conversely, stricter rules will apply to the provision of free samples, including limits related to the duration of treatment.

The amendment also introduces exemptions from regulation, particularly for incentive programmes run by health insurance funds and for educational programmes aimed at non-physician healthcare professionals.

Medical Devices (MD) and In Vitro Diagnostic Medical Devices (IVD)

For medical devices and in vitro diagnostic medical devices, the definition of advertising is both expanded and clarified. Advertising will explicitly include, for example, lotteries, similar games, or consumer experience-based testing.

A more precise definition is also introduced for the recipients of comparative advertising, replacing the previously used general term “professionals”.

As with medicinal products, certain exemptions from regulation are defined.

A separate section is dedicated to patient programmes, which aim to improve awareness of diseases, diagnosis and treatment, as well as to support patient cooperation in healthcare provision and to provide training and guidance on the proper use of prescribed medical devices.

Fines

The amendment introduces new obligations and therefore significantly expands the list of actions (administrative offences) subject to penalties.

A fine of up to CZK 500,000 may newly be imposed, for example, for conducting patient programmes in breach of the law—whether due to violation of their intended purpose, content, or the provision of prohibited benefits to patients. The same fine applies to failure to meet notification obligations towards SÚKL, breaches of hospitality rules in online professional meetings, and similar cases.

Fines of up to CZK 2,000,000 are newly expressly applicable to organising prohibited competitions, lotteries and user tests for medicinal products and medical devices, for missing or outdated information in advertising directed at professionals, or for exceeding limits on the number of samples.

Fines of up to CZK 5,000,000 may be imposed for suggesting that the safety of a medicinal product is guaranteed by its natural origin, for using inappropriate depictions of bodily changes, or for providing gifts and benefits to healthcare professionals that are unrelated to their professional activities, among other violations.

Healthcare professionals themselves may newly face fines of up to CZK 100,000 if they actively request prohibited benefits or excessive hospitality, rather than merely accepting them.

Would you like to stay informed about changes in legislation? Feel free to contact us. 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.

Our knowledge, your opportunity.

The text was translated using ChatGPT 5.2.  

In proceedings concerning the determination or modification of the amount and conditions of permanent reimbursement of medicinal products, where pharmacoeconomic evidence is submitted, comparative clinical efficacy and safety must be demonstrated against all relevant comparators. According to the methodology of the State Institute for Drug Control (SÚKL), relevant comparators may include therapies that are commonly or routinely used and reimbursed from public health insurance. These are not limited to medicinal products.

The requirement for relevant comparators was modified in 2022 for proceedings on the reimbursement of orphan medicinal products (Section 39da), when the advisory body of the Ministry of Health introduced the following requirement for this specific type of proceedings: “…that any future application for reimbursement of an orphan medicinal product for which comparators reimbursed from public health insurance exist (whether with reimbursement determined by the Institute in administrative proceedings or under Section 16 of Act No. 48/1997 Coll.) must include a cost-effectiveness analysis against such comparators.”
As a result, in reimbursement proceedings for orphan medicinal products conducted under Section 39da, therapies reimbursed not routinely but under exceptional reimbursement pursuant to Section 16 are commonly included among comparators—even in cases where their use is off-label within the given indication.

This approach has also been identified in proceedings concerning the determination of permanent reimbursement for a non-orphan medicinal product, where SÚKL likewise accepted as a comparator a product reimbursed under Section 16.
However, in another case involving the use of a comparator reimbursed under Section 16, SÚKL argued in its assessment report, for example, as follows: “…treatment provided under Section 16 of the Public Health Insurance Act is, by its nature, exceptional and cannot be considered the least costly standard option for the purposes of general reimbursement setting…’”

It remains to be seen whether, in the future, the approach to the use of Section 16 comparators will become harmonised across different groups of medicinal products, and whether the position of Section 16–reimbursed treatments will gain greater importance even in standard reimbursement proceedings.

Section 16 of Act No. 48/1997 Coll., on Public Health Insurance
The competent health insurance fund shall reimburse, pursuant to Section 19(1)(a), in exceptional cases healthcare services otherwise not covered by health insurance, provided that the provision of such healthcare services constitutes the only option in view of the insured person’s health condition.

Are you interested in reading regular commentaries on decisions by Pharmeca a.s.? Feel free to contact us.

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.

Our knowledge, your opportunity.

Articles are based on publicly available texts from the decisions of the Ministry of Health of the Czech Republic and the State Institute for Drug Control (SÚKL).

The text was translated using ChatGPT 5.3.  

The Public Health Insurance Act No. 48/1997 Coll. provides in Section 16:

“The competent health insurance fund shall reimburse, pursuant to Section 19(1)(a), in exceptional cases healthcare services otherwise not covered by health insurance, provided that the provision of such healthcare services constitutes the only option in view of the insured person’s health condition.”

That such requests are not rare is evidenced, for example, by statistics published by the General Health Insurance Company of the Czech Republic.

Each European country approaches the pricing and reimbursement of medicines in its own way. The common objective is to ensure access to medicines that meet EU-wide standards of quality, safety and efficacy. However, differences in the design of national systems have a direct impact not only on price levels, but also on the availability of medicines, market structure and manufacturers’ behaviour.

Number of Initiated Proceedings: The Reality of the Czech Market

According to the European Medicines Agency Annual Report (European Medicines Agency, 2025), a total of 114 medicines were authorised through the centralised procedure in 2024, including 46 medicines containing a new active substance (the authorisation of one product was subsequently withdrawn).

Our analysis, conducted as of 1 March 2026, confirms that among medicines containing a new active substance approved by the European Medicines Agency in 2024:

• ✅ Price and reimbursement have been determined for only 5 of the 45 medicines,
• ⏳ Administrative proceedings on price and reimbursement determination are ongoing for 20 medicines,
• 🛑 For 20 medicinal products, the marketing authorisation holder has not yet submitted an application for inclusion in the List of Reimbursed Medicines,
• 🚚 Distribution has been initiated for 16 medicines, regardless of whether reimbursement has been established.

These figures suggest that the path of new innovative medicines to the Czech market is often slow and administratively demanding, which may have a direct impact on both patients and manufacturers.

The Question: Reasons for Delays

The 2025 study Medicines: Regulation versus Patient Needs, conducted by the Initiative for Efficient Healthcare (Hlávka et al., 2025), points out that the strict and long-standing rules governing reimbursement determination are primarily focused on limiting the budgetary impact. Typical measures include:

• reimbursement limited to only part of the indicated patient population,
• prescription restrictions limited to specific medical specialties or specialised healthcare facilities.

Such restrictions directly affect the availability of medicines and may reduce the attractiveness of the Czech market for manufacturers, which can lead to delayed market entry of innovative therapies.

Recommendations: Flexibility and Modern Financing Instruments

The authors of the study recommend:

• introducing a more flexible willingness-to-pay (WTP) threshold, better reflecting disease severity, the level of innovation and patient needs,
• using modern financing mechanisms, such as coverage with evidence development (CED) or risk-sharing arrangements,
• further developing multi-criteria decision analysis (MCDA) for very high-cost medicines.

The study also highlights additional factors affecting the market, including dependence on imports, the underutilised potential of pharmacists, the need to work with real-world data, and the importance of supporting competitiveness and self-sufficiency in the pharmaceutical sector. The patient perspective is not overlooked either:

“For medicines to be effective, it is essential that patients understand their disease and therapy, and that they know why and how to use medicines correctly and safely.”

Source:

European Medicines Agency. (2025). Annual report 2024. Publications Office. https://data.europa.eu/doi/10.2809/6143038

Hlávka, J., Klimková, V., Brychtová, M., Selinger, E., Přecechtěl, Š., Milošič, A., Chadimová, K., Decker, B., Navrátil, M., Vaniš, K., & Kučera, M. (2025, září). IEZ_Studie_Zdravotnictvi pro budoucnost_4-Leciva.pdf. Studie 2025: Léčiva: regulace versus potřeby pacientů. https://www.efektivnizdravotnictvi.cz/post/studie-2025-leciva-regulace-versus-potreby-pacientu

The text was translated using ChatGPT 5.2.  

In 2025, 12 decisions of the State Institute for Drug Control (SÚKL) became legally effective in administrative proceedings relating to the determination of price and reimbursement for orphan medicinal products. Although the system introduced in 2022 is formally structured around SÚKL decisions, the Institute may not deviate from the binding opinion of the Ministry of Health of the Czech Republic.

A simplified process scheme follows:

The determination of prices and reimbursement of medicinal products is based on external price referencing, within which foreign prices denominated in foreign currencies are converted into Czech crowns.

Currently, foreign prices are converted using the quarterly average exchange rate published by the Czech National Bank for the calendar quarter preceding the calendar quarter in which the administrative proceedings were initiated (the “relevant exchange rate”).

According to the amendment to the implementing decree, where no more than three manufacturer prices of a given medicinal product are available and the relevant exchange rate differs by more than 10 % from the average exchange rates over the six quarters preceding the relevant exchange rate, the conversion for the affected medicinal product is carried out using the average exchange rate over those six quarters.

Where more than three manufacturer prices of a given medicinal product are available and the relevant exchange rate differs by more than 10 % from the average exchange rates over the six quarters preceding the relevant exchange rate, such a price is excluded from the calculation.

To make it easier to assess whether these conditions are met, we have updated a visual support tool on our website. 

With a single click, you can now find not only the relevant average exchange rate for the preceding quarter but also its deviation compared to the previous six quarters.