Pharmeca.cz

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in 2024, including 46 medicines containing a new active substance (the authorisation of one product was subsequently withdrawn).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.  

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.