to the point: Healthcare & Life Sciences Q3/2025

On 26 June 2025, the CJEU issued its judgment in C-618/23, SALUS Haus v Astrid Twardy, clarifying the boundary between EU medicines law and organic labelling rules. 

The Court held that traditional herbal medicinal teas registered under Directive 2001/83/EC cannot at the same time fall within the scope of the Organic Regulation (EU) 2018/848. Medicines law takes precedence. As a result, "organic/Bio/Öko" designations and related elements such as the EU organic leaf logo, control code, "EU/Non-EU Agriculture", "Bio", "from organic farming" or private organic marks may not appear on the packaging of such medicines. 

Interpreting Article 62 of Directive 2001/83/EC, the Court confirmed that only information aligned with the product's SmPC and genuinely important for the patient may be added to the outer packaging. References to organic production are neither critical for the patient nor free of promotional character and are therefore impermissible. The ruling leaves no room for importing the organic regime into medicinal labelling for traditionally registered herbal products. The Court thus did not address whether organic labels could be added without satisfying the criteria of Article 62. 

For manufacturers and retailers, we recommend reviewing the packaging of their traditional herbal medicinal products to ensure compliance with the Court's ruling. In particular, organic-related claims or logos should be removed, and labelling for foods or supplements should remain strictly separate from medicinal labelling within the EU.

In C-451/24 (Kwizda II), the Court of Justice of the European Union (CJEU) provided some clarifications on the rule of doubt in Article 2(2) of Directive 2001/83/EC. Back in 2009, the CJEU clarified that the rule does not apply where the status as a medicinal product has not been proven, but also cannot be ruled out (C-140/07). Consequently, the CJEU has now ruled that the rule of doubt (i) applies if the medicinal properties have been proven but classification in another (EU-regulated) category cannot be ruled out, but that it does not apply if (ii) a product clearly falls into another category of regulated products, or (iii) it is certain that the product is a medicinal product and does not fall into any other category. In short, the rule of doubt does not exempt products from being classified according to the definitions provided for by law. If, after examination, the classification is clear and classification in another category is not possible, Article 2(2) of Directive 2001/83/EC does not apply. If, on the other hand, classification into several categories, including that of medicinal products, is possible, classification as a medicinal product takes precedence. 

For some (very Austrian) background: Kwizda marketed products as foods for special medical purposes (FSMP). The food safety authorities objected to this classification, presumably on the formal grounds that the products were food supplements or foodstuffs for general consumption. This resulted in a prohibition order based on Section 39 of the Food Safety and Consumer Protection Act (LMSVG), which was challenged before the Administrative Court in Vienna. The Administrative Court referred several questions to the CJEU. Following the CJEU rulings C-760/21 (Kwizda I) and, previously, C-418/21, it was clear that the products in question were not to be classified as FSMPs, and the Administrative Court confirmed their prohibition under Section 39 LMSVG. The Supreme Administrative Court overturned this decision because the products were to be classified as medicinal products by presentation, which was mandatory in view of the product information required for FSMPs. However, this meant that the food safety authorities lacked jurisdiction and the LMSVG was the incorrect legal basis. The Vienna Administrative Court then asked the CJEU (visibly annoyed) whether, under EU law, food safety authorities could be prevented from prohibiting products marketed as FSMPs that were in fact to be classified as medicinal products by presentation. The CJEU answered in the affirmative, pointing to the clear competence of the Austrian Federal Office for Safety in Health Care (BASG) for enforcing pharmaceutical law. It is for the Member States to ensure the effective enforcement of EU regulations.

On 23 July 2025, the European Medicines Agency (EMA) published an updated version of its Questions and Answers (Q&As) on the External Guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use (Policy 0070).

This is Rev. 4 of that Q&A, which provides practical guidance on the implementation of Policy 0070. The July 2025 updates reflect the updates from May 2025 to the External Guidance on the implementation of Policy 0070 (v1.5)

On 18 July 2025, the European Commission published Guidelines on the scope of obligations of general-purpose artificial intelligence (GPAI) model providers under the AI Act.

The use of GPAI models in the healthcare sector is increasing. The EU AI Act establishes requirements for the use of training data in the development and deployment of GPAI models. These requirements are particularly important when considering the use of health data that is classified as sensitive personal data under EU law. The guidance emphasises that releasing a model under a free and open licence does not exempt providers from their obligations regarding training data transparency and copyright compliance.

Providers are required to document and disclose the types of data used in training, including whether sensitive data such as health information is included. They must ensure that all health data used in training is lawfully obtained and processed in accordance with the principles of the GDPR, including data minimisation, purpose limitation, and the implementation of appropriate technical and organisational measures to protect the rights of data subjects. The guidance further specifies that for models marketed before the AI Act's effective date, providers are not required to retrain or "untrain" models where this is not feasible, but must clearly disclose and justify such restrictions in their copyright policy and training data summary.

In practice, this means that organisations developing or deploying GPAI models in the EU must conduct a thorough review of their training datasets to ensure that all health data involved is processed lawfully and transparently.

Shrinkflation: 2025 verdict raises the bar for consumer transparency

The Vienna Commercial Court issued a landmark ruling on the topic of "shrinkflation" in October 2024, which was upheld by the Vienna Higher Regional Court in the summer of 2025.

The case centred on a food product that, until early 2023, was marketed with a net weight of 250 grams. In early 2023, the net weight was reduced to 220 grams, while the packaging size and price remained unchanged.

As required by food law, the net weight was indicated on the packaging, in this case specifically on the front. However, both courts found this insufficient to prevent potential consumer deception.

The courts considered this to be a misleading business practice: consumers were deceived about the actual price increase because they received less product for the same price. Merely stating the new net weight on the packaging was deemed inadequate to transparently inform customers about the change.

According to the court, it is unreasonable to expect consumers, in the "rush of everyday life", to recognise price increases solely through the indication of the unit price. This is especially true for everyday products.

A particularly striking aspect is that the change took place almost three years ago, in early 2023. In other EU countries, it is argued that deception cannot persist indefinitely. However, the courts in Austria held that the unlawful situation continues, and that the objection of limitation does not apply.

It remains unclear what must be stated on the packaging and for how long. According to the Vienna Higher Regional Court, this question may need to be addressed by the enforcement court.

The ruling underscores that companies must clearly and conspicuously highlight changes in net weight and associated price increases to ensure transparency for consumers.

Politics is responding: the Ministry of Economic Affairs has announced plans for a law targeting "shrinkflation". A draft is expected to be prepared later this year. The exact content of the law is not yet known, but it is expected to at least provide legal certainty regarding the information obligations.

Telemedicine under Bulgarian legislation: what the new draft legislation foresees

Elena Todorova

The Ministry of Health has published for public consultation a draft ordinance (secondary legislative act) on telemedicine. It clarifies the definition of telemedicine, which now includes doctor-to-doctor consultations (regarding a specific patient), if these also occur remotely.

In short, if your doctor examines you over a video link, prescribes treatment or monitors you through home monitoring devices, or discusses your health with a colleague, this falls under the definition of telemedicine.

The draft enables medical institutions to combine functionally into so-called "telecare centres". The idea is for several hospitals or clinics to share specialists, equipment and software to serve a wider range of patients online. The pooling is done by a contract that specifies who coordinates the activities, what structures are involved and how responsibilities are allocated.

The legislator lays down several "red lines", i.e. cases in which telecare is not allowed. These are: dentistry (apart from analysis of imaging studies), childbirth (where only remote consultation between doctors is allowed), and establishment of death. The remote method is not permitted if the identity of the patient cannot be confirmed.

The regulation divides remote medicinal services according to two criteria. By urgency: either scheduled through the National Health Information System (NHIS) or urgent, i.e. requested by another health facility. By mode of implementation: either "with direct interaction", where the patient and doctor communicate in real time, or "without direct interaction" (the so-called store-and-forward model).

The health professional is obliged to enter the results of the remote examination into the NHIS electronic health record within certain time limits. This ensures that the patient and all their doctors have up-to-date information, whether the visit was online or in person.

Medical institutions must meet serious technical requirements. Certificates of conformity (CE marking) are required for all software, communication equipment and medical devices used for the telemedicine service. There must be an uninterruptible power supply so that there is no blackout. A secure computer network is required – separate from the internet, with dual authentication and a non-erasable backup.

The rationale for the ordinance points to several key goals. Easier access to treatment for people in remote settlements or patients with mobility issues. The ordinance does not change the financing method. The prices of remote services will match those of face-to-face services and will be agreed upon in the framework contracts with the Health Insurance Fund.

Longevity clinics are moving from niche to mainstream as more consumers invest in preventive health and personalised performance medicine. The business opportunity is significant, but so are the costs: these clinics demand major investment in facilities, advanced diagnostics and specialist staff, and they face challenges in converting one-time testing into ongoing programmes.

Financing sources for the longevity clinics include:

• Early stage: founders, angels and seed/venture capital for initial buildouts and teams.
• Scale-up: growth equity and venture debt for expansion and digital services.
• Debt and asset finance: bank loans, equipment leasing and real estate sale-leasebacks.
• Strategic partnerships: pilots with insurers or employers, and revenue-sharing with hospitals.
• Recurring revenue: memberships and ongoing coaching to stabilise cash flow.

Investment lifespan is typically five to ten years, with clinics aiming for breakeven in 18–36 months. Exits are usually via acquisition by health platforms or consolidators.

Securitisation may include asset-backed securities on membership receivables or equipment leases. Early-stage clinics rarely qualify, as lenders require multi-site performance and audited financials.

Institutional investors see healthy aging as a durable, multibillion-euro theme. Growth depends on shifting from luxury testing to measurable risk reduction and broader reimbursement options.

A recent case study that may illustrate the above is Blue Longevity Clinic, a Bulgarian start-up that raised EUR 2m in pre-seed funding from Eleven Ventures, Sofia Angels Ventures and family offices. The funds are launching clinics in Sofia, Athens and Istanbul, offering holistic diagnostics and therapies like hyperbaric oxygen and cryotherapy, supported by an AI-driven health platform.

This early-stage funding mix of venture capital and angel investment covers setup, technology and staffing. Blue Longevity aims to expand its network of locations. The founders' backgrounds in health and finance have attracted investor confidence and support future growth, including possible expansion into regenerative medicine.

At the beginning of the summer, the 51^st Bulgarian National Assembly initiated legislative amendments introducing an age-related ban on the sale and marketing of products with high caffeine content to minors (persons under 18). The amendments were incorporated into the Bulgarian Child Protection Act and the Foodstuff Act, alongside broader restrictions in the Tobacco and Tobacco Related Products Act. The legislative process was marked by a lack of transparency and clarity, with little public attention given to the caffeine-related provisions.

Scope and definition

The new law defines "products with high caffeine content" as those with a stimulating effect containing either:

(a) caffeine above 150 mg/l;

(b) an original combination of ingredients such as caffeine, taurine, vitamins and other substances with nutritional or physiological effects (including glucuronolactone, inositol, carnitine, creatine and certain plant extracts).

The definition is notably vague (yes – a conjunction is missing between the two elements of the definition!), leading to uncertainty regarding the scope of products covered by the definition. This ambiguity has caused confusion among stakeholders and industry participants.

According to a non-official statement from the Bulgarian Ministry of Health, all foods and beverages that fall within the scope of it. 4.1. and it. 4.2. (Annex III to Regulation 1169/2011) are covered by the definition of "products with high caffeine content" within the meaning of Section 1, item 25 of the additional provisions of the Child Protection Act (as stipulated in the Bill). The Ministry of Health has also declared itself a non-competent authority to interpret the provision.

Procedural concerns

The legislative amendments triggered notification obligations under the EU's Technical Regulation Information System ("TRIS") procedure. However, Bulgaria's approach was contrary to TRIS procedural requirements, as the law was passed and promulgated before proper notification. The European Commission rejected the notification on the grounds that the law was no longer in draft form. A second notification was then submitted from Bulgaria. The ban's entry into force is tied to the expiry of the EU Commission's objection period under Directive (EU) 2015/1535. The standstill period for this notification ends on 28 October 2025.

At the end of August, the Ministry of Environmental Protection and Green Transition of Croatia proposed the Law on the Implementation of Regulation (EU) 2023/1115 on the making available on the Union market and the export from the Union of certain commodities and products associated with deforestation and forest degradation.

The law introduces a comprehensive system of control for a number of product categories. The goal is to ensure that products placed on or exported from the Union market do not contribute to deforestation and forest degradation, thereby seeking to reduce the EU's contribution to greenhouse gas emissions and global biodiversity loss.

Economic entities and traders will be obliged to establish and maintain a due diligence system. This essentially involves collecting information on the origin of goods, conducting a risk assessment to determine if production is associated with deforestation and forest degradation, and applying measures to mitigate identified risks.

The bodies competent for implementing the law are:

• the Croatian Agency for Agriculture and Food, to verify due diligence systems, provide technical assistance and determine the implementation of a corrective measure for compliance with Regulation (EU) 2023/1115;
• the Customs Administration, to control imports and exports; and
• the Inspectorate, to conduct surveillance on the market, with the power to prohibit the placing of products on the market. 

Legal entities that fail to meet their obligations will be fined from EUR 15,000 to at least 4 % of their total annual turnover at the EU level. Specific fines will apply to responsible persons within a legal entity and natural persons as well. Additionally, other measures may be imposed in accordance with Regulation (EU) 2023/1115, including confiscation of revenues gained by the operator and/or trader from a transaction with the relevant products concerned, or temporary exclusion from public procurement procedures.

On 27 June 2025, the Croatian Parliament unanimously adopted the proposal of the Law on Amendments to the Law on Restrictions on Use of Tobacco and Related Products (the "Law on Tobacco and Related Products"), submitted by the Government of Croatia.

This proposal ensures the transposition into the Croatian legal system of Delegated Directive (EU) 2022/2100[1], specifically regarding the use of flavourings in heated tobacco products and the labelling of such products that are classified as smoking tobacco by their characteristics.

The adoption of the amendments is envisaged by the Programme of the Government of Croatia for the Adoption and Implementation of the EU Acquis for 2025.

Main amendments 

1. The term "heated tobacco products" is introduced – referring to a novel tobacco product that is heated to produce an emission containing nicotine and other chemicals, which is then inhaled by the user. Depending on its characteristics, it may be classified as either a smokeless tobacco product or a smoking tobacco product.
2. The exemption provisions – flavourings may not be used in heated tobacco products.
3. Labelling of heated tobacco products, which are classified as smoking tobacco products by their characteristics.
4. A ban on the sale of nicotine products and heated tobacco products to minors (under the age of 18) is being introduced.
5. To protect people's lives and health, the competent minister may, in the event of the emergence of tobacco and related products that are not regulated by the Law on Tobacco and Related Products and bylaws adopted on the basis of it, issue an immediate order prohibiting the use of such products for a maximum of 12 months.
6. Provisions regarding the powers of competent sanitary inspectors of the State Inspectorate are revised to improve the procedures for taking administrative and misdemeanour measures.
7. The misdemeanour provisions have been amended to reflect the adoption of the euro as the official currency in Croatia.

By introducing these solutions, full harmonisation with corresponding EU provisions is achieved.

Heated tobacco products already on the market may remain in retail sale until supplies last, and no later than 90 days after the Law on Tobacco and Related Products enters into force.

The proposal underwent a consultation process in 2023; however, due to subsequent changes to the text, an additional round of consultation was conducted.

Background

A Czech clinic published an article on its website promoting high-dose vitamin C infusions as a new treatment for cancer and other serious diseases. The text praised patient outcomes, cited oncological centres using the therapy, and advertised the clinic's own services. The article did not name a specific product but mentioned that the infusions are subject to prescription.

The State Institute for Drug Control (SÚKL) fined the clinic CZK 370,000 for advertising a prescription-only medicine (Rx) to the general public. Both the Municipal Court in Prague and the Supreme Administrative Court upheld the fine.

Court's key holding

The Supreme Administrative Court confirmed that the ban on advertising prescription-only medicines to the general public applies even if the medicine is not explicitly named, provided it is clear that the content refers to such a product.

Why it matters

• Indirect references are risky: Promotional content that clearly points to a prescription-only medicine will be treated as advertising, even without naming the product.
• Style matters: Informative, objective content may be acceptable. Promotional tone, selective data or claims about treatment success cross the line.
• High stakes: Significant fines can be imposed, particularly for content targeting vulnerable patients (e.g. cancer patients).

When communicating about therapies involving prescription medicines, it is essential to avoid promotional language and remain strictly factual. Acceptable content includes an accurate presentation of the product's packaging and complete, balanced information from the Summary of Product Characteristics.

An amendment to the Czech Decree on Food Supplements and the Composition of Food has entered into force as of 1 July 2025.

The amendment clarifies that it is no longer permitted to place on the market any food containing certain substances – such as narcotic or psychotropic substances, or substances with anabolic or hormonal effects – even if these are naturally present in the food. Previously, the regulation referred solely to the addition of such substances.

The amendment further introduces numerous changes to the list of regulated and banned plants and substances contained in the Decree. These changes include:

1. Removal of limits for the following plants or substances: Dioscorea sp., Schisandra chinensis, Monascus purpureus (note: limits remain under EU Regulation 1925/2006) and DMAE (dimethylaminoethanol) (considered a novel food).
2. Removal of the following from the list of banned plants and substances: melatonin (foods containing 0.5 mg or more may still be classified as medicinal products by Czech authorities), dehydroepiandrosterone (DHEA) and 5-hydroxytryptophan (5-HTP) (both potentially novel foods).
3. Clematis spp. – only the root is permitted (unless aristolochic acids are present).
4. Atropa spp. – the whole plant is prohibited.
5. Papaver somniferum L. (poppy) – the fruit (except mature seeds) and juice are prohibited.

With respect to the list of regulated and banned plants and substances, it is important to note that the principle of mutual recognition remains unaffected by the changes. Accordingly, a food product containing a plant or substance from the list that has been legally manufactured or placed on the market in an EU Member State may, in general, not be excluded from placement on the market in the Czech Republic. However, this principle does not apply absolutely; it does not apply where the level of protection of a legitimate interest in another Member State is not equivalent to that applicable in the Czech Republic.

The Czech Supreme Administrative Court has confirmed the strict application of the EU novel foods regime to cannabidiol (CBD) products. In its judgment 7 As 83/2024-47, the Court dismissed a cassation complaint brought by a food business operator marketing several food supplements containing CBD (drops with CBD concentrations of 3 %, 6 % and 9 %), produced using supercritical CO₂ extraction. The Court thereby upheld the decision of the State Agricultural and Food Inspection Authority (CAFIA) to withdraw the CBD drops from the market and prohibit their further marketing.

The CAFIA reasoned that the products constituted unauthorised novel foods within the meaning of Regulation (EU) 2015/2283 (the Novel Food Regulation). It relied on the finding that the European Commission had registered an application for the authorisation of a novel food (No. NF 2021/2273), in which the extraction method used (supercritical CO₂) was comparable to that of the claimant. This application had already been validly confirmed. On that basis, the CAFIA concluded that the CBD products were not approved or included on the Union list of novel foods and, therefore, could not be placed on the market.

The food business operator challenged the measure, arguing that hemp plants (Cannabis sativa L.) and the extraction method should not be considered novel, and that the measure was discriminatory, since many other CBD products remained on the market. Both the Municipal Court in Prague and, subsequently, the Supreme Administrative Court rejected these arguments.

Court's reasoning

The Supreme Administrative Court emphasised that Article 6(2) of the Novel Food Regulation prohibits the placing of novel foods on the market without prior authorisation. It is the responsibility of the food business operator to demonstrate either a history of safe use before 15 May 1997 or a valid authorisation. The fact that other CBD products remain available on the market does not undermine the authority's power to act in individual cases.

Key takeaways

1. No authorisation, no market access – CBD products obtained by supercritical CO₂ extraction are considered novel foods and cannot be marketed until approved by the European Commission.
   
   
2. Burden of proof on producers – Businesses must be able to demonstrate either historical safe use or compliance with EU novel food authorisation requirements.
   
   
3. Selective enforcement is lawful – Authorities may act against one operator even if others remain (temporarily) on the market.

Romania has recently enacted significant changes to the VAT regime applicable to food supplements. Until 31 July 2025, food supplements benefited from a reduced VAT rate of 9 %, with certain exceptions – products qualifying as alcoholic beverages, non‑alcoholic beverages classified under NC code 2202 and foods with added sugar where the total sugar content is at least 10 g per 100 g (excluding infant milk powder, cozonac, biscuits and bee feed).

Starting 1 August 2025, Law 141/2025 expressly excludes "food supplements", as defined by Law 56/2021, from the reduced VAT rate. Consequently, these products will be subject to the standard VAT rate. However, there is a carve‑out: Law 56/2021 does not apply to supplements based on medicinal or aromatic plants and bee products regulated by Law 491/2003. Such products may still benefit from the reduced VAT rate, provided they also fall within the categories eligible for the reduced rate under the Fiscal Code and its methodological norms. Additionally, Law 141/2025 updates the VAT rates, raising the reduced rate from 9 % to 11 % and the standard rate from 19 % to 21 %.

These changes have several practical implications for businesses. Companies should review their product portfolios to distinguish between items qualifying as "food supplements" under Law 56/2021, which will now be taxed at 21 %, and herbal or bee‑based supplements under Law 491/2003, which may remain at the 11 % reduced rate if they meet fiscal eligibility criteria. It is also important to verify CN/NC classifications (for example, NC 2202 beverages remain excluded from the reduced rate) and to check sugar thresholds for products with added sugar.

Nutri-Score is a front-of-pack nutritional labelling system already adopted voluntarily by several European countries.

In 2024, Romanian authorities initiated a draft government decision aiming to regulate the conditions under which Nutri-Score could be used in Romania. The proposed requirements included notifying the National Authority for Consumer Protection (ANPC) in writing and providing proof of authorisation from Santé Publique France (owner of the Nutri‑Score mark), using QR codes to disclose nutritional values, and separating the display of Nutri‑Score labelled products.

Following the objections raised in the EU notification process that the draft may impose excessive obligations and raise compatibility issues with the principle of free movement of goods under Article 34 of the Treaty on the Functioning of the European Union (TFEU), the draft was withdrawn.

Nevertheless, in June 2025, the Romanian authorities again attempted to regulate Nutri-Score and submitted a new draft Government Decision to the European Commission, proposing a framework for the national implementation of the Nutri-Score system.

In September 2025, the European Commission issued a detailed opinion raising significant concerns regarding the Romanian draft. Key aspects identified include:

1. provisions that may conflict with EU law and the principle of free movement of goods, specifically the prohibition on quantitative restrictions on imports and all measures having equivalent effect under Article 34 TFEU;
2. redundant obligations imposed on food business operators, which are already addressed by existing EU legislation (i.e. the obligation to ensure that consumers are informed fully, correctly and accurately regarding the nutritional values of the products subject to these special mentions);
3. the use of an outdated version of the Nutri-Score calculation, differing from the updated version currently applied in other Member States, which may create inconsistencies and distortions in the single market.

As a result of the Commission's detailed opinion, the standstill period has been extended until 10 December 2025. During this time, the Romanian authorities must decide whether to amend the draft in line with the received feedback or proceed with the current version, accepting the potential risk of infringement proceedings by the European Commission.