Key Healthcare, Pharma and Food Law Changes in the Czech Republic and EU in 2026

17.3.2026 | ARROWS law firm

The year 2026 marks a period of significant legislative developments for the healthcare, pharmaceutical, and food sectors in the Czech Republic and across the European Union. These changes respond to the need to modernise EU pharmaceutical legislation, regulate new categories of substances, and the ongoing digitalisation of healthcare. The following article provides a legal and practical overview for entrepreneurs, healthcare facility management, and manufacturers.

The illustrative image depicts a specialist consulting on legislative changes in the healthcare sector.

Article contents

Price regulation of medicinal products and medical devices
Regulation of medical devices and e-vouchers
EU Pharmaceutical Package: Reform of medicines legislation
Borderline products: Food supplements vs. medicinal products
Practical regulatory risks
Dentistry: The end of amalgam

Quick summary

EU reform of medicines legislation: The European Union is finalising new rules for marketing authorisations for medicinal products, shortening the period of market protection, and supporting the development of antibiotics.
Psychomodulatory substances: Expected entry into force in the Czech Republic of legislation regulating substances such as kratom or psychoactive cannabis derivatives (HHC), which will not be treated as foods but as a new category with strict sales rules.
Regulation of “borderline” products: Emphasis on strict differentiation between food supplements and medicinal products based on CJEU case law and the decision-making practice of SÚKL (the Czech State Institute for Drug Control).
Price regulation and reimbursement: Changes to reimbursement mechanisms for medical devices and an increased focus on cost-effectiveness (HTA) when introducing new technologies in the Czech Republic.
Digitalisation: The next phase of implementing the Czech Act on the Digitalisation of Healthcare, expanding e-requests and telemedicine.

Price regulation of medicinal products and medical devices

In 2026, it remains the case in the Czech Republic that the prices of medicinal products and foods for special medical purposes are regulated primarily by Act No. 48/1997 Coll., on Public Health Insurance, and Act No. 526/1990 Coll., on Prices. The Ministry of Health issues an annual Price Regulation setting out the rules for substantive price control.

A key area remains the setting of maximum prices and reimbursement from public health insurance, which is carried out by the State Institute for Drug Control (SÚKL) in administrative proceedings. SÚKL decisions are administrative decisions subject to judicial review in Czech courts. For 2026, it is crucial to monitor revisions of reimbursement systems, especially in the area of highly innovative medicinal products (VILP).

Legislation under Czech law places increasing emphasis on demonstrating cost-effectiveness and risk-sharing between payers and marketing authorisation holders. Manufacturers and distributors must be prepared for more complex negotiations with healthcare payers.

For medical devices, the trend of categorisation and reimbursement limits under the Public Health Insurance Act continues. Manufacturers must ensure timely notification of changes and inclusion in reimbursement groups, while the Institute (SÚKL) assesses substitutability and effectiveness.

Key aspects of price regulation

Judicial review: Regulated entities have the right to challenge unlawful pricing decisions or measures of a general nature by filing an administrative action. Case law of the Czech administrative courts in this area further clarifies the limits of SÚKL’s discretion.

Split margins: The system of trade mark-ups for distribution and pharmacies is subject to regular amendments in the Price Regulation. It is essential to follow the current wording for the relevant calendar year, which defines maximum mark-up limits depending on the ex-factory price.

Regulation of medical devices and e-vouchers

The medical devices sector is fully influenced by the European MDR (Medical Devices Regulation). In 2026, many transitional provisions are pivotal for full adaptation to stricter requirements for clinical evaluation and post-market surveillance.

In the Czech Republic, electronic prescribing is the standard. Vouchers for medical devices are issued electronically (e-voucher), which is a mandatory system fully integrated into the eRecept services administered by SÚKL. Paper form is permitted only in specific exceptional situations defined by Czech law.

Practical impacts of medical device regulation

1. Advertising ban: It is necessary to strictly comply with Act No. 40/1995 Coll., on Advertising Regulation, which has been amended in recent years and targeted at communications to the general public (ban on influencer marketing, competitions, etc. for reimbursed devices).

2. Reimbursement caps: Reimbursed aids are subject to so-called reimbursement limits. If the price of a device exceeds the reimbursement set in the Categorisation Tree, the patient pays the difference. Manufacturers must not compensate this co-payment through unfair commercial practices.

EU Pharmaceutical Package: Reform of medicines legislation

The European Union continues the process of approving and implementing the so-called Pharmaceutical Package. The aim of this reform is to revise the general pharmaceutical legislation. Although the final wording and effective date depend on the EU legislative process, the key proposed changes include:

Modulation of the protection period: A proposal to shorten the basic period of regulatory data protection (RDP), with the possibility of extension if a medicine meets specific criteria (launch in all Member States, addressing unmet medical needs).
Bolar exemption: Expansion of the so-called Bolar exemption, intended to allow generic and biosimilar manufacturers to start development and regulatory processes earlier so they can enter the market immediately after the originator’s patent protection expires.
Environment: Stricter requirements for environmental risk assessment (ERA) in the marketing authorisation process for medicinal products.
Fighting resistance (AMR): Introduction of incentives for the development of new antibiotics, including discussions on transferable exclusivity vouchers.

For Czech entities, this means the need to monitor the transposition of these directives and directly applicable regulations, which will affect strategies for bringing new medicines to market in the Czech Republic.

Borderline products: Food supplements vs. medicinal products

The issue of so-called borderline products remains one of the legally riskiest areas. The distinction between a food supplement (food) and a medicinal product is governed by the definitions in Act No. 378/2007 Coll., on Medicinal Products and the case law of the Court of Justice of the European Union (CJEU).

It is crucial to distinguish a medicinal product by presentation (packaging, advertising) and a medicinal product by function (pharmacological effect). If a product meets the definition of a medicinal product, it must be authorised as a medicinal product; otherwise, it is an illegal product.

The CJEU has long held that a decision on the classification of a product must be taken on a case-by-case basis, taking into account all of its characteristics. If a product is placed on the market as a food supplement but has the characteristics of a medicinal product or is presented as such, it may be withdrawn from the market in the Czech Republic.

Notification and health claims

In the Czech Republic, food supplements are subject to a notification obligation towards the Ministry of Agriculture before they are first placed on the market. However, the key area is the regulation of health claims under Regulation (EC) No. 1924/2006.

For food supplements, it is strictly prohibited to use medicinal claims, i.e., claims that the product treats or prevents a disease. Only approved health claims are permitted, for example the so-called “on hold” list for herbs or approved claims for vitamins and minerals.

Breaches of these rules are sanctioned by the Czech Agriculture and Food Inspection Authority (Státní zemědělská a potravinářská inspekce – SZPI). Fines in this area can reach multi-million CZK amounts and are often accompanied by an order to withdraw products from sale.

Practical regulatory risks

Risk	Legal basis and sanctions	How ARROWS helps (office@arws.cz)
Medicinal claims for food supplements	Breach of Regulations 1169/2011 and 1924/2006. Fine from SZPI up to CZK 50 million. May be classified as misleading consumers under Czech law.	Legal review of labels and e-shop content. Using only approved claims.
Borderline products	Classification of the product as an unregistered medicinal product by SÚKL (the Czech State Institute for Drug Control). Withdrawal from the market, fine up to CZK 20 million (Act on Medicinal Products).	Expert assessment of composition and mechanism of action before placing on the market.
Lack of awareness of the Psychomodulants Act	Sale of substances (Kratom, HHC) without registration/licence or in breach of the ban on sales to minors. High sanctions.	Monitoring the new Act on addictive substances in the Czech Republic, registration with the relevant authorities, age verification (Age Check).
Incorrect advertising of medical devices	Breach of the Czech Advertising Regulation Act (targeting the general public for reimbursed medical devices, competitions). Fine up to CZK 5 million.	Compliance review of marketing campaigns, especially on social media and with influencers.

New category: Psychomodulatory substances (kratom, cannabis derivatives)

In response to the rise of substances such as kratom and HHC, the Czech Republic has prepared a legislative framework for so-called psychomodulatory substances. This draft law amending the Act on Addictive Substances aims to create a new category between foods and prohibited drugs.

If the legislative process proceeds as expected, the following rules will apply to these substances from 2026 or earlier. These will mainly include a ban on sales to minors, sales only in specialised shops, and significant restrictions on marketing.

This solution is intended to replace the current “grey” situation where these substances are sold as “collectors’ items”. The new regulation will also introduce mandatory laboratory testing and specific labelling with risk warnings.

Psychedelics and medicine

It is necessary to set the record straight regarding information about psychedelics such as psilocybin. In the Czech Republic, psilocybin is not legalised for standard treatment or free sale and remains on the list of prohibited narcotic and psychotropic substances.

Its use is possible exclusively:

Within approved .
In exceptional cases within specific treatment programmes or individual import with the consent of the Czech Ministry of Health (MZ ČR).

Any claims about full legalisation of psilocybin in 2026 are misleading. The Czech Republic is a leader in research, not in deregulation for commercial use.

Dentistry: The end of amalgam

In line with Regulation (EU) 2017/852 of the European Parliament and of the Council on mercury, there is a gradual move towards a complete ban on the use of dental amalgam. From 1 January 2025, the EU ban on the use of amalgam for dental treatment applies, with narrow exceptions for specific medical needs.

In 2026, the use of mercury-free alternatives such as composites or glass ionomers will therefore be the standard. In the Czech Republic, health insurance companies are adjusting reimbursement systems accordingly to ensure the availability of alternative fillings for insured persons.

Digitisation and administration

The Czech Act on the Digitisation of Healthcare is gradually coming into full effect, which means that healthcare providers are required to use eHealth systems. Secure communication with patients and payers and the development of telemedicine within a legally safe framework are essential.

Health insurance companies require communication exclusively electronically via data boxes (datové schránky) or insurers’ portals. This trend is becoming an absolute standard, and paper alternatives in administration are practically disappearing.

Conclusion and recommendations

The year 2026 brings stricter and more precise rules. The era of “grey zones”, for example with kratom or borderline food supplements, is coming to an end. For entrepreneurs, this means the need to invest in compliance and legal risk prevention under Czech law.

Recommended steps:

1. Product portfolio audit: Verify that your food supplements do not contain prohibited medicinal claims or substances newly regulated as psychomodulants in the Czech Republic.

2. Monitoring price regulations: For medicinal products and medical devices, monitor the bulletins of the Czech Ministry of Health (MZ ČR) and SÚKL.

3. Digitisation: Ensure full compatibility with eHealth systems.