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in 2024, including 46 medicines containing a new active substance (the authorisation of one product was subsequently withdrawn).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