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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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Healthcare & Life Science
In the 21st century, healthcare and life science is a growing and socially important industry, dedicated to improving quality of life by encouraging healthy living, managing diseases more effectively and making the best use of technology. Pharma and medical technology are at the heart of advances in medicine and the driving force behind digitalisation in…
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Navigating the Digital Landscape into 2025 – EU Regulatory Reforms and their Impact on the Life Sciences Industries
The current era is witnessing unprecedented technological developments and advancements. The world of health care is no exception, with several digital innovations making their way into the industry. Join us for the upcoming webinar “Navigating the Digital Landscape into 2025: EU Regulatory Reforms and their Impact on the Life Science Industries” on 28 January 2025…
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unyer Webinar Health Care & Life Science | Resolving Disputes in the Health Care & Life Science Industry
unyer would like to invite you to our upcoming webinar, where we will explore the complexities of resolving disputes within the Health Care & Life Science Industry. Join us for an insightful session where industry experts will shed light on various challenging scenarios and legal considerations. Disputes in Italian and European Pharmaceutical Markets We will…
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Defending a medical device maker in parallel proceedings
Product liability claims in France, Germany and Italy, answered with one strategy and one line of defence.
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One data protection framework for a digital health platform
From impact assessments to authority audits: one compliance framework for a platform active in twelve EU states.
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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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Conducting health research in France? What the CNIL’s updated standards mean for you
The French data privacy commission (the “CNIL”) has updated two data processing standards for research involving personal health data in order to respond to major changes in the health research sector ie the increasing digitisation and decentralisation of research, social and environmental considerations at the heart of new methods, stricter testing requirements for health products…
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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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How Far Must Medical Device Distributors Go? New CJEU Guidance on MDR Compliance
The Court of Justice of the European Union (CJEU) has recently delivered an important judgment clarifying the obligations of distributors of medical devices under the Medical Device Regulation (MDR). In its judgment of 4 June 2026 in Case C-10/24 (Dürr Dental), the Court addressed a practical question that many companies throughout the medical device supply…
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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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AI Act: New Perspectives for the Healthcare Sector – Current implementation status
With the adoption of Regulation (EU) 2024/1689, known as the AI Act, the European Union has established for the first time a systematic and binding framework for artificial intelligence, becoming a pioneer in the regulation of a technology which is bound to profoundly affect the economy, fundamental rights and essential services. One of the sectors…
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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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Telemedicine and Cross-Border Healthcare after CJEU Case C-115/24 – essential guidance for healthcare providers and digital-health platforms offering telemedicine services across EU borders
On 11 September 2025, the Court of Justice of the European Union (CJEU) rendered its judgment in case C-115/24 (UJ v Österreichische Zahnärztekammer). The ruling is of major importance for cross-border healthcare in the EU, especially where telemedicine (remote care via information and communication technology (ICT)) is combined with in-person treatment. For practitioners advising on…
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Critical medicines shortages: European Court of Auditors’ report highlights harms of stockpiling after France increases associated fines
In 2023, the European Commission warned that “The COVID-19 pandemic and the Russian military aggression against Ukraine [have] exposed Europe’s supply chains dependencies and the risk that economic dependency could be weaponised. This has also heightened awareness of the risk of medicine shortfalls, experienced across all Member States and involving both original and generic medicines.”…
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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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The New Hospital Improvement Act: addressing challenges in the German Health Care Sector
In the dynamic landscape of the German hospital sector, several challenges and developments are currently taking centre stage that affect both the quality of care and the economic stability of the facilities. Quality competition between hospitals is a key challenge. There is deliberate competition between hospitals, focussing on the quality of medical care. This competition…
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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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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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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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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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Case study from France: contingency stock measures for a future Critical Medicines Act
On 24 September 2024, the French national agency for the safety of medicines and health products (the “’ANSM’) announced the imposition of financial sanctions totalling nearly eight million euros against 11 pharmaceutical companies for non-compliance with their legal obligations to keep a contingency stock of so-called medicines of major therapeutic interest. These sanctions have been…
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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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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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Violation of the pharmacy reservation pursuant to Section 59 of the Austrian Medicines Act (AMG) by a specialist doctor?
The Supreme Court (OGH) dealt with this question in its recently published decision of March 19, 2024 on 4 Ob 42/24s and commented on a few fundamental questions. The use of Ozempic in people who are not severely obese or do not suffer from diabetes, but want to lose weight easily, has been the subject…
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Product liability of medtech companies on the German market: International regulations vs. national liability
The safety of medical devices is of utmost importance for the health of patients around the world. Numerous regulations, particularly by the European Commission, are therefore commonplace in this industry. Just recently, the EU launched the AI Act to regulate artificial intelligence, with further requirements explicitly for the manufacture of medical devices. However, while the…
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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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Revolutionising Healthcare and Life Science Supply Chains with Metaverse Technology
The Healthcare and Life Science sector is currently facing numerous supply chain challenges arising from the shortage of materials, increased costs, and staff shortages due to the COVID-19 pandemic, wars, and other ongoing crises. It is now more crucial than ever to address these challenges, and one way to do so is by utilising new…
