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

Price regulation of medicinal products and medical devices

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

Under Czech legislation, there is a growing 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 Act on Public Health Insurance continues. Manufacturers must ensure timely notification of changes and inclusion in reimbursement groups, with the Institute (SÚKL) assessing interchangeability and effectiveness.

Key aspects of price regulation

Judicial review: Regulated entities have the right to defend themselves against unlawful price decisions or measures of a general nature through an administrative action. The case law of administrative courts in this area refines the boundaries of SÚKL's discretion.

Degressive margins: The system of commercial margins for distribution and pharmacies is subject to regular adjustments in the Price Regulation. It is essential to monitor the current version for the given calendar year, which defines the maximum margin limits depending on the ex-factory price.

Regulation of medical devices and e-vouchers

The field of medical devices is fully influenced by the European Medical Devices Regulation (MDR). For many transitional provisions, 2026 is a key year for full adaptation to the stricter requirements for clinical evaluation and post-market surveillance.

In the Czech Republic, the electronisation of prescriptions is standard. Vouchers for medical devices are issued electronically (e-voucher), a mandatory system fully integrated into the ePrescription services managed by SÚKL. Paper form is permissible only in specific, legally defined exceptional situations.

Practical impacts of medical device regulation

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

2. Reimbursement ceilings: So-called reimbursement limits apply to reimbursed devices. If the price of the device exceeds the reimbursement set in the Categorisation Tree, the patient pays the difference. Manufacturers must not compensate for this co-payment through unfair commercial practices.

EU Pharmaceutical Package: Reform of medicinal legislation

The European Union is continuing 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 form 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 extending it if the medicine meets specific criteria (market launch in all Member States, addressing unmet medical needs).

• Bolar exemption: An extension of the so-called Bolar exemption, which is intended to allow manufacturers of generics and biosimilars to begin development and regulatory processes earlier so they can enter the market immediately after the original's patent protection expires.

• Environment: Stricter requirements for environmental risk assessments (ERA) during the marketing authorisation of medicinal products.

• Combating antimicrobial resistance (AMR): The 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 market entry strategies for new medicines.

Borderline products: Food supplements vs. medicinal products

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

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

The CJEU has long held that the decision on a product's classification must be made on a case-by-case basis, taking into account all of its characteristics. If a product is marketed as a food supplement but has the properties of a medicinal product or is presented as such, it is at risk of being withdrawn from the market.

Notification and health claims

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

For food supplements, it is strictly forbidden to use medicinal claims, i.e., claims that the product treats or prevents a disease. Only approved health claims are permitted, such as the so-called 'on hold' list for botanicals or approved claims for vitamins and minerals.

Violation of these rules is penalised by the Czech Agriculture and Food Inspection Authority (CAFIA). Fines in this area can reach millions of crowns and are often associated with an order to withdraw the products from sale.

Practical threats in regulation

New category: Psychomodulant substances (kratom, cannabis derivatives)

In response to the proliferation of substances like kratom and HHC, the Czech Republic has prepared a legislative framework for so-called psychomodulant substances. This bill, which amends the Act on Addictive Substances, aims to create a new category between foodstuffs and illicit drugs.

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

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

Psychedelics and medicine

It is necessary to clarify the information about psychedelics, such as psilocybin. In the Czech Republic, psilocybin is not legalised for routine treatment or over-the-counter sale and remains on the list of prohibited narcotic and psychotropic substances.

Its use is possible exclusively:

1. Within approved clinical trials.

2. In exceptional cases, as part of specific treatment programmes or individual imports with the consent of the Ministry of Health of the Czech Republic.

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

Dentistry: The end of amalgam

In accordance with Regulation (EU) 2017/852 of the European Parliament and of the Council on Mercury, the use of dental amalgam is being gradually phased out completely. From 1 January 2025, a ban on the use of amalgam for treating teeth will apply in the EU, with narrow exceptions for specific medical needs.

By 2026, the use of mercury-free alternatives, such as composites or glass ionomers, will be standard. Health insurance funds in the Czech Republic are consequently adjusting their reimbursement systems to ensure the availability of alternative fillings for insured persons.

Electronisation and administration

The Act on the Electronisation of Healthcare is gradually coming into full effect, which means an obligation for healthcare providers to use eHealth systems. Secure communication with patients and payers and the development of telemedicine within a legally secure framework are essential.

Health insurance funds require communication exclusively electronically via data boxes or insurer portals. This trend is becoming the absolute standard, and paper-based 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, for kratom or borderline food supplements, is coming to an end. For entrepreneurs, this means the need to invest in compliance and legal prevention.

Recommended steps:

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

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

3. Digitalisation: Ensure full compatibility with eHealth systems.

For entrepreneurs, management, and investors, mistakes in this area can mean not only administrative penalties but also product withdrawals from the market, distribution restrictions, reputational damage, or an impact on the value of the entire investment. It is therefore advisable to address legal and regulatory risks preventively, rather than waiting for an inspection or a dispute to arise.

If you do not want to risk mistakes, financial losses, delays, or penalties, the Prague-based ARROWS law firm can help you with a regulatory audit, setting up compliance, checking products and marketing communications, and addressing specific requirements from supervisory authorities.