Pharmeca.cz

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.

Pharmeca a.s. provides services within the scope defined by the following legislative framework:

Act No. 48/1997 Coll., on Public Health Insurance and on Amendments to Certain Related Acts, as amended.  

Implementing regulations (selected):

• Decree No. 376/2011 Coll., implementing certain provisions of the Public Health Insurance Act, as amended,
• Notice of the Ministry of Health No. 529/2025 Coll., on the antigenic composition of vaccines against pneumococcal infections for vaccination of insured persons over 65 years of age
• Notice of the Ministry of Health No. 23/2024 Coll., on the antigenic composition of vaccines against pneumococcal infections for childhood vaccination and for insured persons with health risk factors
• Notice of the Ministry of Health No. 273/2024 Coll., on the antigenic composition of reimbursed vaccines for influenza vaccination of persons over 65 years of age
• Notice of the Ministry of Health No. 474/2021 Coll., on the antigenic composition of reimbursed vaccines against human papillomavirus
• Decree No. 432/2025 Coll., on the determination of the value of a point, reimbursement levels for reimbursed services, advance payments, and regulatory limitations for 2026
• Notice of the Czech Statistical Office No. 159/2018 Coll., introducing the CZ-DRG classification of hospitalized patients
• Decree No  384/2007 Coll., on the list of reference groups, as amended,
• Decree No  385/2007 Coll., on the list of medicinal substances intended for supportive or adjunctive treatment, as amended,
• Decree No. 63/2007 Coll., on reimbursement of medicinal products and foods for special medical purposes, as amended.
• Decree No. 618/2006 Coll., issuing framework contracts, as amended,
• Decree No. 134/1998 Coll., issuing the list of healthcare procedures with point values, as amended,
• Decree No. 527/2021 Coll., on the determination of the amount of reimbursement of expenses for expert acts and the method for determining the amount of reimbursement of expenses for expert consultations carried out by the State Institute for Drug Control pursuant to the Act on Public Health Insurance, as amended,
• Decree on the determination of the value of a point, reimbursement levels for reimbursed services and regulatory limitations – issued annually for the relevant period,
• Government Regulation No. 307/2012 Coll., on local and temporal availability of healthcare services, as amended.

Act No. 551/1991 Coll., on the General Health Insurance Company of the Czech Republic, as amended.

Act No. 280/1992 Coll., on sectoral, professional, company and other health insurance companies, as amended.

Implementing regulations to the Health Insurance Acts (selected):

• Decree No. 421/2025 Coll., on the determination of certain contributions from the fund of generally beneficial activities of the General Health Insurance Company of the Czech Republic and sectoral, professional, company and other health insurance companies for 2026, as amended
• Decree No. 125/2018 Coll., on information contained in health insurance plans and outlooks and on the method of their submission by health insurance companies, as amended
• Decree No. 362/2010 Coll., on the method of providing information on the financial management of health insurance companies and its scope, as amended
• Decree No. 418/2003 Coll., laying down more detailed specification of the scope and amount of income and expenditure of public health insurance funds of health insurance companies, the conditions for their creation, use, permissibility of mutual transfers of financial resources and their management, the limit of operating costs of health insurance companies covered from the resources of the basic fund including the method of calculation of this limit, as amended
• Decree No. 41/2000 Coll., laying down detailed conditions for the creation and use of financial resources of the funds of the Military Health Insurance Company of the Czech Republic for reimbursement of healthcare provided beyond the scope of public health insurance from the state budget resources of the Ministry of Defence, as amended
• Measure of the Ministry of Health determining financial performance indicators of health insurance companies for the relevant year

Act No. 592/1992 Coll., on Premiums for Public Health Insurance, as amended.

Implementing Regulation:

• Government Regulation No. 357/2025 Coll., on the assessment base for public health insurance premiums paid by the state for 2026
• Decree No. 107/2025 Coll., on adjustable parameters of redistribution of public health insurance premiums for 2026 and on the content, structure and format of data for calculation of the calculated redistribution parameters
• Decree No. 65/2025 Coll., on the method of valuation of costs of healthcare services for the purposes of redistribution of public health insurance premiums
• Decree No. 351/2022 Coll., on the transfer of data on consumption of medicinal products by insured persons of public health insurance when changing a health insurance company, as amended

Act No. 526/1990  Coll., on Prices, as amended.

Price regulations / price decisions – Medicinal Products (selected):

• Price Decision of the Ministry of Health No. 1/2026/OLZP, on price regulation of medicinal products and foods for special medical purposes
• Price Decision of the Ministry of Health No. 2/2026/OLZP, establishing the list of ATC groups of medicinal products significant for the provision of healthcare, for which the maximum manufacturer price is determined in the public interest of ensuring availability
• Price Decision No. 2/2025/OLZP, on price regulation of individually prepared medicinal products containing cannabis for medical use
• Price Regulation of the Ministry of Health No. 4/2024/OLZP, on the determination of a special distribution margin for medicinal products released from reserve stock system,

Price Decisions – Medical Devices:

• Price Decision of the Ministry of Health No. 3/2026/OLZP of 24 October 2025, on price regulation of medical devices and in vitro diagnostic medical devices

 Act No. 378/2007 Coll., on Medicinal Products and on Amendments to Certain Related Acts, as amended.

 Implementing regulation (selected):

• Government Regulation No. 552/2025 Coll., on conditions for prescribing, dispensing and use of individually prepared medicinal products containing psilocybin for medical use
• Decree No. 457/2023 Coll., laying down the list of human medicinal products to which the obligation of the marketing authorisation holder to ensure their supply after the notified date of interruption or termination of supplies does not apply, as amended.
• Decree No. 84/2008 Coll., on Good Pharmacy Practice, on detailed conditions for handling medicinal products in pharmacies, healthcare facilities and by other operators and establishments dispensing medicinal products, as amended,
• Decree No. 85/2008 Coll., laying down the list of medicinal substances and excipients that may be used for the preparation of medicinal products, as amended,
• Decree No. 86/2008 Coll., laying down the principles of Good Laboratory Practice in the field of medicinal products, as amended
• Decree No. 106/2008 Coll., on Good Practice for sellers of restricted medicinal products and on the professional training course for sellers of restricted medicinal products, as amended
• Decree No. 143/2008 Coll., on human blood, as amended
• Decree No. 228/2008 Coll., on registration of medicinal products, as amended,
• Decree No. 229/2008 Coll., on the manufacture and distribution of medicinal products, as amended,
• Decree No. 236/2015 Coll., laying down the conditions for prescribing, preparation, distribution, dispensing and use of individually prepared medicinal products containing cannabis for medical use, as amended,
• Decree No. 329/2019 Coll., on prescribing medicinal products in the provision of healthcare services, as amended,
• Decree No. 463/2021 Coll., on the detailed conditions for conduct of clinical trials of human medicinal products, as amended.

Act No 167/1998 Coll, on Addictive Substances and on Amendments to Certain Other Acts, as amended

Implementing regulation (selected):

• Government Regulation No. 552/2025 Coll., on the conditions for prescribing, dispensing and use of individually prepared medicinal products containing psilocybin for medical use, as amended
• Government Regulation No. 456/2025 Coll., on the list of psychomodulatory substances, as amended
• Decree No. 448/2025 Coll., on psychomodulatory substances, as amended
• Decree No. 349/2025 Coll., on the requirements for notifications submitted by persons cultivating opium poppy and technical hemp, as amended
• Decree No. 147/2025 Coll., on specimen forms and records of psychomodulatory substances and classified psychoactive substances, as amended
• Government Regulation No. 11/2025 Coll., on the list of classified psychoactive substances, as amended
• Decree No. 53/2014 Coll., on official forms pursuant to the Act on Addictive Substances, as amended,
• Decree No. 123/2006 Coll., on records and documentation of addictive substances and preparations containing them, as amended,
• Decree No. 243/2009 Coll., laying down the list of persons, including specification of their workplaces, for whose activities no permit for handling addictive substances or preparations containing them is required, as amended,
• Government Regulation No. 463/2013 Coll., on the lists of addictive substances, as amended,
• Decree No. 235/2022 Coll., on the cultivation and processing of cannabis plants for medicinal use, as amended,
• Decree No 53/2022 Coll., on the determination of the amount of reimbursement of expenses for expert acts carried out by the State Institute for Drug Control pursuant to the Act on Addictive Substances, as amended.
• Decree No. 329/2019 Coll., on prescribing medicinal products in the provision of healthcare services, as amended by Decree No. 53/2020 Coll., as amended

Act No. 288/2025 Coll., on the Categorisation of Medical Devices Prescribed on Vouchers Reimbursed from Public Health Insurance and on Amendments to Act No. 48/1997 Coll., on Public Health Insurance and on Amendments to Certain Related Acts (the Medical Devices Categorisation Act), as amended

Act No. 375/2022 Coll., on Medical Devices and In Vitro Diagnostic Medical Devices, as amended. 

Implementing regulation (selected):

• Decree No 377/2022 Coll., implementing certain provisions of the Act on Medical Devices and In Vitro Diagnostic Medical Devices, as amended, 
• Decree No. 378/2022 Coll., on the specimen inspector identification card of the State Institute for Drug Control pursuant to the Act on Medical Devices and In Vitro Diagnostic Medical Devices, as amended.
• Decree No 379/2022 Coll., on the determination of the amount of reimbursement of expenses for expert acts carried out by the State Institute for Drug Control pursuant to the Act on Medical Devices and In Vitro Diagnostic Medical Devices, as amended. 

Act No 376/2022 Coll., amending certain Acts in connection with the adoption of the Act on Medical Devices and In Vitro Diagnostic Medical Devices, as amended.

Act No. 268/2014 Coll., In Vitro Diagnostic Medical Devices, as amended.

Act No. 89/2021 Coll., on Medical Devices and on Amendments to Act No. 378/2007 Coll., on Medicinal Products and on Amendments to Certain Related Acts (the Medicinal Products Act), as amended.

Implementing regulation:

• Notification of the Ministry of Health No. 54/2022 Coll., on the commissioning of the central repository of electronic vouchers.

Act No. 22/1997 Coll., on Technical Requirements for Products and on Amendments to Certain Related Acts, as amended.  

Act No. 90/2016 Coll., on Conformity Assessment of Specified Products when Supplied on the Market, as amended.

Act No. 325/2021 Coll., on Healthcare Digitalisation, as amended, and other related acts, as amended

Act No. 372/2011 Coll., on Health Services and Conditions for Their Provision (the Health Services Act), as amended.  

Implementing regulations (selected):

• Decree No. 380/2025 Coll., on emergency medical on-call services, as amended
• Decree No. 30/2025 Coll., on telemedicine health services, as amended
• Decree No. 444/2024 Coll., on healthcare documentation, as amended
• Decree No. 373/2016 Coll., on the transfer of data to the National Health Information System, as amended
• Decree No. 70/2012 Coll., on preventive medical examinations, as amended
• Decree No. 39/2012 Coll., on dispensary care, as amended

Act No. 40/1995 Coll., on Regulation of Advertising and on Amendments to Act No. 468/1991 Coll., on the Operation of Radio and Television Broadcasting, as amended.

Act No 242/2022 Coll., on Video-sharing Platform Services and on Amendments to Certain Related Acts (the Video-Sharing Platform Services Act), as amended.

Act No. 387/2024 Coll., on General Product Safety and on Amendments to Certain Related Acts, as amended.

Act No. 500/2004 Coll., the Administrative Procedure Code, as amended.

Current price decisions, opinions and methodological gudelines or regulations of the Ministry of Health of the Czech Republic.

Instructions and guidelines of SÚKL.

At the beginning of December, the State Institute for Drug Control (SÚKL) held a seminar entitled Current Topics in Price and Reimbursement Regulation. The following article presents key practical information delivered at the seminar and includes SÚKL’s interpretation of selected topics previously addressed in the Dawn of the Amendment to the Public Health Insurance Act series.

This article is therefore a transcription of texts based on presentations published on the SÚKL website, where their full versions are available.

Vaccine Reimbursement as of 2026

The amendment in the area of medicinal products intended for immunisation will ensure full reimbursement of more effective and more modern vaccines.

By submitting an application for the determination of reimbursement pursuant to Section 39db et seq., it is possible to request:

• reimbursement of new indications of an already reimbursed vaccine, resulting in the determination of an additional reimbursement entry in the List of Reimbursed Medicinal Products (SCAU);
• reimbursement in an indication already reimbursed under the previous legislation, resulting in the revocation of the existing reimbursement and the determination of a new one.
  In the event of a partial overlap between the newly proposed reimbursement conditions and an existing reimbursed indication, the Institute will revoke the existing reimbursement only in the overlapping part and determine a new reimbursement for that part.
• reimbursement of a vaccine not previously reimbursed, by submitting an application for the determination of the maximum price and the amount and conditions of reimbursement (MC and VaPÚ).

Joint Proceedings Concerning Combinations of Medicinal Products

Types of administrative proceedings under the amendment:

• VILP + VILP combination – procedure pursuant to Section 39d et seq. of the Public Health Insurance Act (ZoVZP);
• LPVO + VILP combination – procedure pursuant to Section 39da et seq. ZoVZP;
• LPVO + LPVO combination – procedure pursuant to Section 39da et seq. ZoVZP.

Administrative proceedings are initiated only upon submission of the second application, which must be filed within 30 days of the first application. The web-based application forms have been amended to require explicit indication that the case concerns a joint proceeding with another medicinal product.

Withdrawal of one of the applications leads to termination of the proceedings; all applicants have dispositive rights over the subject matter of the application.

Assessment of Highly innovative medicinal product (VILP) status

• In VILP + VILP applications, VILP status is not assessed separately for each medicinal product used in combination; the combination as a whole must meet the VILP criteria.
• In LPVO + VILP applications, VILP criteria are not assessed in any orphan indication. The VILP already has temporary reimbursement established in another indication.
  
  

Assessment of Orphan (LPVO) Status

• In LPVO + LPVO applications, both products have active orphan status; at least one of them has orphan status in the given indication.
• In LPVO + non-reimbursed medicinal product without orphan status, the non-orphan product must have the relevant orphan indication included in its SPC.

Similar Medicinal Products (PP)

Initiation of an abbreviated review (ZR) following entry of the first PP

Under the amendment, the abbreviated review is initiated only after verification of commercial availability (pursuant to Sections 13a and 13b of Decree No. 376/2011 Coll.) of a reimbursed similar product in relation to the originally reimbursed product.

The market share of all similar products within the relevant ATC group is assessed for a given calendar month, excluding the originally reimbursed product:

• PP in a reference group containing prescription-only medicines: at least a 5% share of the average monthly volume (DIS-13);
• PP in a reference group containing only separately reimbursed medicinal products (ZÚLP): at least a 2% share of the average monthly volume (REG-13).

Comprehensive and Abbreviated Reviews

Comprehensive review (HR)

Section 39l(3): a reduction of the base reimbursement by more than 80% compared to the base reimbursement established in the first completed comprehensive review.

• For reference groups containing prescription medicines, SÚKL will remove indication restrictions (except for off-label indications) and reassess prescribing restrictions.
• For reference groups containing ZÚLP, SÚKL will reassess indication restrictions, with possible removal following BIA assessment.

The justification for applying this provision is assessed either directly within the ongoing comprehensive review or after issuance of a decision in an abbreviated review in which reimbursement decreased by more than 80%.

A comprehensive review cannot be initiated if, within the last 12 months, a decision has been issued in another comprehensive review within the same group of essentially therapeutically interchangeable medicinal products.

In an individual administrative proceeding (ISŘ) concerning a change in the amount and conditions of reimbursement (VaPÚ), it is not possible to establish more restrictive reimbursement conditions than those set in the most recent comprehensive review.

Abbreviated review (ZR)

Abbreviated reimbursement reviews are differentiated for groups containing ZÚLP (savings of CZK 20 million) and groups not containing ZÚLP (savings of CZK 30 million).

Removal of the statutory three-year time limit for conducting an abbreviated maximum price review.

Abbreviated reviews (cost-saving, including savings based on DNC/DoÚ) cannot be initiated if another abbreviated review decision for the same medicinal product group was issued within the last 12 months.

Abbreviated maximum price reviews are conducted for reference groups or groups of essentially therapeutically interchangeable products (the rule based on active substance and route of administration has been removed).

Changes Affecting VILP and LPVO

VILP criteria

a) The primary clinically relevant endpoint in the clinical trial demonstrated at least a 30% improvement in a quality-of-life–relevant parameter in direct comparison, or at least a 35% improvement in indirect comparison versus reimbursed therapy; in the case of progression-free survival, median PFS must be extended by at least three months; or

b) Median overall survival is prolonged by at least 30% versus reimbursed therapy, and by at least three months; where median OS is not reached, a reduction in the OS hazard ratio of at least 35% versus reimbursed therapy is demonstrated; or

c) A medicinal product with conditional marketing authorisation pursuant to Regulation (EC) No 726/2004, where no alternative with permanent or temporary reimbursement exists, or where the alternative is supportive or symptomatic treatment only, and the MAH has committed to reimbursing health insurance funds for costs incurred should the conditional authorisation expire, lapse or be withdrawn.

For medicinal products with conditional marketing authorisation applying for VILP status under point (c), criteria under points (a) and (b) are not assessed. The sole condition is the absence of causal treatment within the reimbursement system and the conclusion of an agreement.

Assessment of Benefits and Costs of Hospital Medicinal Products

Section 17(6): ...upon request of a health insurance fund or MAH, the Institute assesses the benefits and costs associated with the use of such medicinal products. MAHs, health insurance funds and relevant professional societies provide cooperation.

• This is not a formalised process (i.e. not administrative proceedings or an OOP).
• A non-public file is established; access pursuant to Section 38 of the Administrative Procedure Code.
• SÚKL does not act as a regulator issuing a substantive decision.
• SÚKL does not decide on the amount and conditions of reimbursement of hospital medicinal products listed in SCUP.
• SÚKL processes submitted documentation from health insurance companies, marketing authorisation holders, and professional societies in an impartial manner.
• Assessment compares costs and benefits of the hospital medicinal product versus alternative treatment options.

Submission of Pharmacoeconomic Models

Models – general requirements

• Preferred format: Excel or TreeAge.
• Fully functional, allowing parameter adjustments with automatic recalculation of results.
• Non-functional models, incorrect formulas or source codes trigger a request for correction.
• Technical documentation must be submitted (does not replace structured submission).
• Maximum recalculation time: 10 seconds; justified cases 30–60 seconds.
• Required for all types of administrative proceedings (determination/change, VILP §39d, LPVO §39da, immunisation products §39db ZoVZP).

Determination of the Maximum Manufacturer Price of Medicinal Products  

The procedure for determining the maximum price (MC) for medicinal products that are significant for the provision of healthcare and which the Ministry of Health, with regard to the public interest in maintaining their availability, designates in a special price measure (Section 39a(3)) is as follows:

a) the average of prices in up to seven reference basket countries, provided that the medicinal product is present in at least two reference basket countries;

b) the average of identified prices within the EU, where point (a) cannot be applied;

c) a therapeutically comparable medicinal product (TPLP) in the Czech Republic, where points (a) and (b) cannot be applied
(i.e. the lowest price of a medicinal product containing the same active substance, pharmaceutical form and strength; where more than one TPLP exists, the lowest price of the medicinal product with the same or the closest pack size is used);

d) the average price of TPLP in the reference basket, where points (a) to (c) cannot be applied
(from each reference basket country, the lowest price of a medicinal product containing the same active substance, pharmaceutical form and strength is used; where more than one such product exists, the lowest price of the medicinal product with the same or the closest pack size is applied).

Determination of MC / Price Referencing

Pursuant to the amendment to Decree No. 376/2011 Coll., new rules apply concerning the relevant exchange rate and exceptions in situations where, during price referencing for the purpose of MC determination, the exchange rate deviation exceeds 10% compared to the average quarterly exchange rates over the preceding six calendar months:

• where no more than three medicinal product prices are identified, conversion is carried out using the average exchange rate for the preceding six calendar quarters prior to the relevant exchange rate (Section 3(2) of the Decree);
• where more than three medicinal product prices are identified, any price whose relevant exchange rate deviates by more than 10% from the average quarterly exchange rates over the preceding six calendar quarters is excluded (Section 7(2) of the Decree).
  
  

Exclusion of a Foreign Price from External Reference Pricing

• The deviation of the lowest identified price exceeds 20% compared to the average of the second and third lowest prices, the average of the second and third lowest prices or the DNCV is applied (Section 7(1) of the Decree);
• More than three prices are identified, SÚKL excludes the price associated with an exchange rate that deviates by more than 10% from the average exchange rate over the preceding six calendar quarters (Section 7(2) of the Decree);
• Market-wide regulatory measures affecting the market have been introduced in an EU Member State and SÚKL has received official information from the competent authority of that Member State or from the Ministry of Health (Section 7(3) of the Decree).

Determination of Reimbursement for Medicinal Products

Determination of the base reimbursement amount (Section 39c(2)(a) of the Public Health Insurance Act)

Manufacturer price / ODTD in the EU:

• where it is demonstrated in administrative proceedings that the medicinal product is not present on the market in a given EU country, such price reference is excluded;
• availability requirements:
  • medicinal products within substitutability on the Czech market ≥ 5%;
  • a similar product for six months from the date on which the decision determining its reimbursement amount and conditions becomes enforceable, at the latest until another reimbursed similar product becomes available pursuant to Section 39b(4), first sentence, excluding the originally reimbursed product;
  • a medicinal product with a concluded DNCV (maximum manufacturer price agreement) or DoÚ (reimbursement agreement) for six months from the effective date of the written agreement.
  
  

Determination of Reimbursement / Price Referencing

Where the relevant exchange rate deviates by more than 10% compared to the average quarterly exchange rates of the foreign exchange market published by the Czech National Bank over the preceding six calendar quarters, conversion into Czech currency is carried out using the average exchange rate published by the Czech National Bank over the preceding six calendar quarters (Section 11(2) of the Decree).

Determination of Base Reimbursement / Price Referencing

In the event of the introduction of market-wide measures, the Institute excludes the identified foreign manufacturer price in the EU Member State analogously pursuant to Section 7(3) (Section 12(4) of the Decree).

Where the deviation of the lowest identified price is ≥ 20% compared to the average of the second and third lowest prices, the price extreme is excluded. This does not apply to VILP and LPVO (Section 16(2) of the Decree).

Source: 

YOUNG, Michaela; ŽÁČKOVÁ, Kristýna a CHYTILOVÁ, Petra. Seminář SÚKL č. 19 – Sekce cenové a úhradové regulace: Úhrada vakcín 2026. Online. In: . 2025. Dostupné z: https://sukl.gov.cz/wp-content/uploads/2025/10/5.-Uhrada-vakcin-2026.pdf. [cit. 2025-12-18].
ŠVORCOVÁ, Tatiana; CHYTILOVÁ, Petra a VYSEKALOVÁ, Eva. Seminář SÚKL č. 19 – Sekce cenové a úhradové regulace: Novela ZoVZP - další změny. Online. In: . 2025. Dostupné z: https://sukl.gov.cz/wp-content/uploads/2025/10/6.-Novela-ZoVZP-%E2%80%93-dalsi-zmeny.pdf. [cit. 2025-12-18].

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