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Health Claims Under Scrutiny: The CJEU Clarifies the Rules for Food Supplement Advertising
Food supplement advertising is subject to strict EU rules. Under Regulation (EC) No 1924/2006 (the Nutrition and Health Claims Regulation, NHCR), health claims – statements that state, suggest or imply a relationship between a food, or one of its constituents, and health – must generally be authorised and comply with the applicable conditions of use.…
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MyHealth@EU: How Health Data Compliance Is Changing
On 21 September 2026, the European Commission published two new regulations in the Official Journal of the European Union, defining crucial operational aspects of the European Health Data Space. Rules and regulations governing digital health are undergoing an unprecedented transformation: the European Union intends to enforce a material revision of legal compliance strategies for companies…
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Italy adapts its legal framework to the EU AI Act: new rules on damage caused by AI systems and access to evidence
On 30 September 2026, Legislative Decree No. 160/2026 (“Legislative Decree No. 160/2026”) came into effect. The decree was adopted in accordance with Article 24 of Law No. 132 of 23 September 2025, with the aim of aligning the Italian legal framework with Regulation (EU) 2024/1689 (the AI Act), which establishes the European regulatory framework for…
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Online sales and marketplaces: The new frontier of distribution control
Abstract The distribution battle has moved online. The competition law framework governing online sales has undergone a seismic shift. The Digital Markets Act (DMA[i]), which came into force on 4 November 2024, has fundamentally reshaped how suppliers can control digital distribution channels. Simultaneously, the Platform to Business Regulation (P2B)[ii] and sectoral enforcement across…
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Defence as a Commercial Challenge: Contract Structuring for Reliable Supply, Innovation and Growth
The security and defence industry is entering a period of significant growth. For established manufacturers as well as new technology providers, this is not merely a matter of securing additional contracts. The real challenge lies in transforming development work, pilot projects and individual procurement contracts into robust production, supply and service relationships. Initially, the focus…
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French 3% Tax on real estate assets: Changes Resulting from the Law on Combating Social Security and Tax Fraud
The French Law on Combating Social Security and Tax Fraud introduces significant changes to the French 3% annual tax regime applicable to entities holding, directly or indirectly, French real estate. The main change is the abolition of the disclosure commitment mechanism. Entities that previously relied on a simple undertaking to provide ownership information upon request…
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Greenwashing: from sustainability claims to compliance evidence
In recent years, “being green” has become a powerful marketing tool. Consumers increasingly reward brands that appear sustainable, and companies are keen to communicate their environmental commitments. But the regulatory environment has changed, it is no longer enough to say that a product, brand or business is sustainable, companies must be able to prove it.…
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Medical devices: one more issue before the Constitutional Court
Pending litigation in Italy Around two thousands of claims were raised in 2023 before the Italian Administrative Court of Rome against the so called ‘payback system’ according to which the supplier of medical devices were requested to contribute to the coverage of the regional governments’ public expenditure on medical devices in excess of a certain…
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German merger control law restricted (even further) for hospital mergers
For hospital mergers, the latest change to German merger control law shifts powers more markedly away from the Federal Cartel Office and to the level of the 16 states (“Länder”). Even if the revenue thresholds for the application of German merger control law are exceeded, hospital mergers will need to be notified first to the…
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‘Fast track’: France’s new accelerated clinical trial authorisation pilot initiative launches
On 16 March 2026, France’s National Agency for the Safety of Medicines and Health Products (“ANSM”) launched a pilot fast-track procedure for the authorisation of clinical trials on medicinal products for human use (”MPHU”) that are carried out in France. As highlighted by the ANSM, against a backdrop of fierce international competition in clinical…
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Legal privilege “à la française“
Abstract On 23 February 2026, Law n°2026-122 on the confidentiality of consultations written by in-house lawyers was enacted, amending the 31 December 1971 Law reforming certain judicial and legal professions. Two days later, it was published in the “Journal Officiel”[i]. It will come into force no later than twelve months after its promulgation, under the…
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Austrian Supreme Court refers IUD case to the CJEU: Is loss of earnings after an unwanted pregnancy “personal injury” under EU product liability law?
In decision 2 Ob 77/25z, the Austrian Supreme Court (OGH) has referred a highly sensitive and practically important question to the Court of Justice of the European Union (CJEU): Does the loss of earnings suffered by a woman as a result of an unwanted pregnancy caused by a defective intrauterine device (IUD) qualify as “damage caused by death or personal…
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Navigating the new landscape: key pillars of the EU Packaging and Packaging Waste Regulation (EU) 2025/40
The European Union has taken an important step towards a circular economy with the adoption of Regulation (EU) 2025/40 on packaging and packaging waste (“PPWR”). This legislation, which repeals the long-standing Directive 94/62/CE, establishes a harmonized legal framework aimed at introducing new obligations that will reshape how packaging is designed, used, and managed across its…
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2026 – No turning point in the number of corporate insolvencies in Germany Payment defaults & international risks of insolvency contestation remain high
Is your company sufficiently protected if a customer from Germany is no longer able to pay for the goods delivered or services provided? For companies, this question often arises only in the context of an imminent threat of payment default by their customers. Often underestimated is the significant risk that payments already received can be…
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NATO significantly increases defence spending – Legal challenges for a security and defence industry 5.0
Secretary General Mark Rutte’s statement at the press conference following the conclusion of the NATO summit in June 2025 was clear: It is time to ‘roll up our sleeves to put this new plan into action.’ Prior to this, NATO member states had agreed in their final declaration to invest five per cent of gross…
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Launching and operating a food or beverage trademark within the European Union market: How to successfully manage coexistence with PDOs and PGIs?
The Member States of the European Union have a vast and diverse heritage of local food and drink products. The European Union, with its 27 Member States, is the world’s leading exporter of agri-food products. French champagne, Italian Parma ham, Spanish Manchego cheese and Greek Kalamata olives are just a few of the products…
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Turning ESG Requirements into Contractual Strategy in the Life Sciences Sector
Environmental, Social and Governance (ESG) considerations have moved from the periphery to the core of legal and strategic decision-making across the life sciences industry. For pharma, biotech and medical device companies, all operating complex global supply chains, ESG is no longer a voluntary aspiration. It is quickly becoming a binding legal requirement. With the German…
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IT security is at a crossroads
IT security: a multidimensional challenge IT security is no longer limited to technical considerations. It now requires a comprehensive approach that integrates technical, organizational, managerial, and legal skills. This cross-functional nature requires close cooperation between different departments within the company to define clear objectives, measure risks, and implement corrective and/or preventive actions. Despite growing awareness…
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The EU Data Act
What is the EU Data Act? The EU Data Act establishes harmonised rules regarding the fair access to and use of data across digital markets. Its overarching goal is to Promote competition, innovation and the free flow of data within the EU – with particular attention to data generated by connected (IoT) products and related…
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Austrian Supreme Court on Distinctiveness of Colour Combinations as Trademarks
Decision 4 Ob 109/25w, 22 July 2025 The Austrian Supreme Court (OGH) dismissed an extraordinary appeal concerning the registration of a blue-green colour combination as an abstract trade mark for a wide range of goods and services (including fuels, retail services with regard to food and drinks, energy production, software development, and catering). Key Issues The applicant…
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“Shrinkflation” and Price Transparency: New Developments
In recent years, there has been a growing phenomenon that consumers receive less of a product for the same price – a practice known as “shrinkflation”. Shrinkflation is defined as a business practice whereby contents of a product are reduced while the package and price remain unchanged. This practice effectively results in a hidden increase…
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Arbitration Involving Public Entities: Why So Much Hate?
At the invitation of unyer, several public law and arbitration specialists gathered in Paris to explore a question that remains highly topical: what role can (or should) arbitration play in disputes involving public entities? Despite recent developments, recourse to arbitration remains very limited when a public entity is involved. The speakers analyzed the persistent legal,…
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Payback on sales of medical devices – New Regulation of the Italian Government
Around two thousands of claims were raised before the Italian Administrative Court of Rome against the Ministerial and Regional Decrees which, implementing the Legislative Decree 2015, No. 78, Article 9-ter, required the supplier of medical devices many years after – at the end of 2022 – to pay an amount corresponding to the percentage incidence…
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Discounts on Reimbursable Medicinal Products in France: A Dialogue Under Pressure
Prices, margins and discounts on reimbursable medicinal products in France are strictly regulated, in particular to control public health expenditures. The rules governing these discounts are laid down in the Social Security Code (“CSS”), mainly in Article L.138-9, and have recently been amended by the Social Security Financing Act for 2025 (Law No. 2025-199 of…
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Managing trade barriers – What the new US tariffs mean for international supply contracts
The US tariffs on imports from all countries have greatly unsettled the global economy. According to US President Trump, the EU is to be subject to tariffs of on exports to the USA. For the European Union (EU), for example, tariffs of 20 % are to apply to exports to the USA. Shortly afterwards, US…
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What the European Health Data Space Means for Pharmaceutical Companies
New Rules, New Opportunities On 5 March 2025, the European Union adopted the European Health Data Space (EHDS) through Regulation (EU) 2025/327. This marks the EU’s most ambitious attempt yet to unlock the potential of health data – while safeguarding fundamental rights. The EHDS introduces a unified legal framework for the use of electronic health data across Member States. It…
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The Digital Services Act (DSA)
What is the DSA The Digital Services Act (DSA), officially known as EU Regulation 2022/2065, represents a critical development in the European Union’s regulatory framework, introduced to address the dynamic and complex challenges of the digital age. Together with the Digital Markets Act (DMA), it forms part of the comprehensive Digital Services Package, aiming to…
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Green Claims Directive- What to expect and how to anticipate?
Context and objectives of the Directive In March 2023, the EU Commission published a proposal for a Directive on substantiation and communication of explicit environmental claims (Green Claims Directive), which aims to fight greenwashing by ensuring that environmental claims are reliable, comparable and verifiable. The proposal is currently under discussion in the European Parliament, and…
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Payback on sales of medical devices – Pending litigation in Italy
Around two thousand claims raised in 2023 are still pending before the Italian Administrative Court of Rome against the Ministerial and Regional Decrees which, implementing the Legislative Decree 2015, No. 78, Article 9-ter, required the supplier of medical devices many years after – at the end of 2022 – to pay an amount corresponding to…
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Geo-blocking: Ongoing challenges for cross-border online-trade
The EU Commission has recently once again conducted several market screenings and one result is already clear as day: (Online) traders should review their digital distribution to avoid penalties. With Regulation (EU) 2018/302 (“Geo-blocking Regulation”), the EU legislature wanted to unify the digital single market and counteract the established separation of digital markets through unjustified…
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The new EU General Product Safety Regulation – GPSR
Relevance also for medical devices from 13 December 2024 The EU General Product Safety Regulation 2023/98 – GPSR, published on 23 May 2024, will enter into force on 13 December 2024 and will be directly applicable from that date. The GPSR lays down general rules for the safety of consumer products placed on the market…
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Protecting Patients: Italy Adapting to EU Standards for Authenticity of Medicines
From 9 February 2025, Italy too will be interconnected with the major European hub for verifying the authenticity of medicines before they are dispensed to patients. Our country, together with Belgium and Greece, has taken advantage of a six-year derogation for the adaptation of the drug traceability system to the standards provided for by the…
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Going Digital: Opportunities and Challenges for Medical Tech
The digitalisation of the healthcare system is an important step towards more effective and efficient healthcare. Advances in medical technology such as Wearables, robot-assisted surgery and Artificial Intelligence (AI) are also being used more and more frequently in the healthcare sector. The EU and the German Federal Ministry of Health (Bundesministerium für Gesundheit; “BMG”) have…
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Payback Litigation – News from the Constitutional Court
Numerous appeals are still pending before the Regional Administrative Court for Lazio against the deed issued in December 2022 by the Regions, based on Article 9-ter of the Legislative Decree No. 78/2015 (as amended by the Legislative Decree No. 115/2022), ordering the suppliers of medical devices to public administrations to pay a contribution for the…
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Legal implications of the Crowdstrike incident: a wake-up call for IT security
On July 19, a serious IT security incident shook the digital world. A faulty update by the renowned security company Crowdstrike for its Falcon software led to massive computer failures at companies and organizations worldwide. The effects were dramatic: airplanes were grounded, hospitals had to cancel operations and numerous companies were faced with significant operational…
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The EU’s withdrawal from the Energy Charter Treaty: a setback for investors protection or a step forward for climate protection?
On June 27, 2024, the European Union announced its withdrawal from the Energy Charter Treaty (ECT). This move potentially marks the end of a long and difficult negotiation process on the reform of the treaty, which was originally intended to promote and protect investment in the energy sector. Given the undisputed need to promote investment…
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France implements first sector-wide agreement on ecological transition in the pharmaceutical industry
On October 17, 2023, the French pharmaceutical industry signed its first sector-wide agreement on ecological transition and sustainable mobility. The agreement, signed between Leem and the CFDT, CFTC, FO and Unsa federations, requires companies to carry out a carbon assessment of their activities by October 17, 2024, and to adopt two best practices from among…
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unyer advised on De Dietrich Process Systems` cross border strategic acquisition of HEINKEL Drying & Separation Group
Member law firms Fidal, Luther, and Pirola Pennuto Zei & Associati advised De Dietrich Process Systems on its acquisition of the HEINKEL Drying & Separation Group. This strategic acquisition enables De Dietrich to enrich and expand its portfolio of solutions for its customers, offering the most comprehensive premium range on the market. The acquisition ensures…
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REMIT II enters into force: Important changes for energy trading
1. Background On May 7, 2024, Regulation (EU) 2024/1106, better known as “REMIT II“, came into force. This marks the first amendment to REMIT, the Regulation on Wholesale Energy Market Integrity and Transparency, which has been in force since early 2012. The adoption of REMIT II is part of the European package of measures to…
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unyer members Fidal and Luther advised Click&Boat on a cross-border merger
unyer member law firms Fidal and Luther have advised France’s leading provider of boat hire services on the takeover of Hamburg-based Scansail Yachts International GmbH. The French Click&Boat (Clickandboat S.A.S.) is pushing ahead with consolidation in the charter market. As part of a cross-border merger, the company has integrated Scansail Yachts International GmbH, headquartered in…
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Payback on sales of medical devices
Pending litigation in Italy Around two thousands of claims were raised before the Italian Administrative Court of Rome against the Ministerial and Regional Decrees which, implementing the Legislative Decree 2015, No. 78, Article 9-ter, required the supplier of medical devices many years after – at the end of 2022 – to pay an amount…
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Proposed EU AI Act’s application to medical devices
The recitals of the proposal for a Regulation laying down harmonised rules on artificial intelligence (the “AI Act”) states that “By improving prediction, optimising operations and resource allocation … the use of artificial intelligence can provide key competitive advantages to companies and support socially and environmentally beneficial outcomes”, in particular in the area of healthcare.[1]…
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Meet our team at the EXPO REAL in Munich 2023 from 4 to 6 October 2023
unyer will be in Munich with partners from Fidal, KWR, Luther and Pirola. For any inquiries or requests please contact us under contact@unyer.com.
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unyer Cocktail Reception at the IBA Annual Conference in Paris 2023
unyer Cocktail Reception at the IBA Annual Conference in Paris Monday, 30 October 2023, 7:00 p.m. to 10:00 p.m. Location: Automobile Club de France – 6 Place de la Concorde, Paris For any inquiries or requests please contact iba@unyer.com.
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Meet our team at the IBA Annual Conference in Paris 2023 from 29 October to 3 November 2023
unyer will be in Paris with partners from Fidal, KWR, Luther and Pirola. For any inquiries or requests please contact iba@unyer.com.
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Meet the unyer team at INTA, in one of the most scenic locations in Singapore, Sands Expo and Convention Center!
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unyer: the new international and interprofessional network created by Fidal and Luther
The two founding partners are extending their international reach and taking a new step in their strategic development by forming a branded organisation of leading international professional services firms. unyer has only one member per country and offers more than just legal services. Sharing a similar mind set and providing a full service offering, members…
