European Union: Food, Drugs, Healthcare, Life Sciences

Every few months, I find myself in a familiar conversation with a foreign investor who is approaching a French transaction for the first time. They have done cross-border deals before, and have done their research. They usually arrive with a version of the same assumption: that France is more complicated than it needs to be, that the regulatory environment is from a different era, and that with the right advisors, the complexity can be “figured out.”

Belgium's federal Chamber of Representatives has adopted a comprehensive bill introducing significant changes to pharmaceutical reimbursement procedures, including simplified approval tracks, new combination therapy rules, and an 80 million EUR annual industry contribution. The legislation also addresses drug unavailability issues and postpones certain 2024 reforms until 2028, fundamentally reshaping the financial and operational landscape for pharmaceutical companies operating in Belgium.

The European Union has spent the last decade reshaping the digital regulatory landscape through landmark legislation such as the General Data Protection Regulation (GDPR) and the AI Act. The European Health Data Space (EHDS) Regulation is the next significant step in that evolution. While often described as a healthcare initiative, the EHDS is at its core a data governance framework designed to unlock the value of electronic health data while safeguarding fundamental rights and promoting innovation.

Generative AI is transforming antibody patent prosecution at the European Patent Office, where a single word—'routine'—now determines both enablement and obviousness.

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.

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

A pharmaceutical company's trademark dispute over 'CannaMed' raises critical questions about brand protection in the rapidly evolving cannabis and medical sectors. The case highlights the intersection of traditional pharmaceutical branding with emerging cannabis industry nomenclature. Legal and commercial implications of this trademark conflict could set important precedents for companies operating at the convergence of these two industries.

Belgium's federal Chamber of Representatives has adopted a comprehensive bill introducing significant changes to pharmaceutical reimbursement procedures, including simplified approval tracks, new combination therapy rules, and an 80 million EUR annual industry contribution. The legislation also addresses drug unavailability issues and postpones certain 2024 reforms until 2028, fundamentally reshaping the financial and operational landscape for pharmaceutical companies operating in Belgium.

Northern Ireland's Food Standards Agency and Department of Health are consulting on new restrictions for promoting products high in fat, sugar and salt, aiming to align with UK-wide measures while grappling with which nutrient profiling model to adopt. The proposed regulations would limit volume price promotions, product placement in prominent retail locations, and free refill promotions for sugar-sweetened drinks, with enforcement handled by local councils.