European Union: Food, Drugs, Healthcare, Life Sciences

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Welcome to the Mondaq Food, Drugs, Healthcare, Life Sciences homepage, here you will find thought leadership articles, podcasts, videos and webinars providing insights covering topics such as Food and Drugs Law, Healthcare, Life Sciences, Biotechnology and Nanotechnology.
Article
From Profit Distribution Ban To A New Cap-and-conditions Regime In Dutch Healthcare
The Dutch government has announced a significant shift in healthcare regulation, moving away from a fragmented prohibition on profit distribution toward a uniform 'cap-and-conditions' regime that will apply to all healthcare and youth aid providers. This new approach permits profit distribution up to a maximum percentage of invested capital, but only under strict conditions including quality standards, financial health requirements, and enhanced governance measures. The proposed changes also introduce tight
Netherlands Healthcare
LL
Loyens & Loeff
Article
OPEN Ears Episode 21 Is Out!
Leadership advisor Tune Hein shares exclusive insights from his five-year experience as an internal specialist at Novo Nordisk during the launch of Wegovy, one of the pharmaceutical industry's most significant obesity drug introductions. What are the 10 core beliefs that propelled Novo Nordisk to become one of the world's most valuable companies, and how did their unconventional approach to scaling, management, and organizational structure drive their success in the competitive obesity drug market?
Denmark Healthcare
a
aera
Article
Life Sciences Outlook 2026
Arthur Cox's Life Sciences Outlook 2026 examines critical regulatory developments and strategic opportunities shaping Ireland's life sciences sector. The publication explores Ireland's EU Council Presidency and its potential impact on advancing key legislative initiatives including the Biotech Act I and medical device reforms. Industry leaders will find comprehensive analysis spanning pharmaceutical compliance, medtech regulation, data governance, M&A activity, and environmental considerations.
Ireland Healthcare
AC
Arthur Cox
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Life Sciences, Biotechnology & Nanotechnology

Article
European Commission Opens First Formal Antitrust Investigation In The Medical Devices Sector
The European Commission has launched its first formal antitrust investigation in the medical devices sector, examining whether Align Technology may have abused its dominant position by restricting interoperability between its Invisalign clear aligners and competing intra-oral scanners. The investigation focuses on allegations that the company created a closed ecosystem, forcing dental professionals to purchase iTero scanners to access Invisalign products for their patients.
European Union Anti-trust
AO
A&O Shearman
Article
OECD Issues Two New Test Guidelines For Nanomaterials
The OECD has released two groundbreaking test guidelines specifically designed for nanomaterials, addressing critical gaps in standardized testing methods for dustiness determination and environmental fate assessment. These new protocols provide regulatory frameworks for measuring how nano-objects behave under various conditions, supporting decision-making processes across OECD member countries. The guidelines build upon existing OECD testing standards while introducing specialized methodologies tailored to
France Environment
BC
Bergeson & Campbell
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Food and Drugs Law

Article
Playing Loose – CJEU Asked To Decide On Combination SPCs
The EU Court of Justice faces a pivotal decision on whether medicines approved as monotherapy but labeled for use in combination with other drugs qualify for Supplementary Protection Certificate (SPC) protection as combinations of active ingredients. This referral, stemming from Genmab's attempts to secure SPC protection for loose combinations including daratumumab, could resolve over a decade of legal uncertainty and fundamentally reshape how pharmaceutical companies approach regulatory strategy for combin
Denmark IP
HL
HGF Ltd
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Healthcare

Article
European Commission Opens First Formal Antitrust Investigation In The Medical Devices Sector
The European Commission has launched its first formal antitrust investigation in the medical devices sector, examining whether Align Technology may have abused its dominant position by restricting interoperability between its Invisalign clear aligners and competing intra-oral scanners. The investigation focuses on allegations that the company created a closed ecosystem, forcing dental professionals to purchase iTero scanners to access Invisalign products for their patients.
European Union Anti-trust
AO
A&O Shearman
Article
From Profit Distribution Ban To A New Cap-and-conditions Regime In Dutch Healthcare
The Dutch government has announced a significant shift in healthcare regulation, moving away from a fragmented prohibition on profit distribution toward a uniform 'cap-and-conditions' regime that will apply to all healthcare and youth aid providers. This new approach permits profit distribution up to a maximum percentage of invested capital, but only under strict conditions including quality standards, financial health requirements, and enhanced governance measures. The proposed changes also introduce tight
Netherlands Healthcare
LL
Loyens & Loeff
See more

Latest Videos

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