European Union: Healthcare

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.

The Belgian Federal Agency for Medicines and Health Products has issued comprehensive new guidance on pharmaceutical promotion to healthcare professionals, consolidating previous circulars and introducing stricter...

Headnote: The claimant’s legitimate interest in the publication of a decision (Art. 80 UPCA) may, depending on the circumstances of the individual case, follow from the fact that the defendant has marketed the attacked embodiment by explicitly referencing to the key technology protected by the patent

Effective service date for an unrepresented defendant who did not yet make an appearance in court is calculated under R. 271.6.b RoP, subject to the “unless” conditions of that rule.

Gérard Haas et son équipe ont compilé les actualités juridiques numériques les plus marquantes de la semaine, couvrant les alertes d'Anthropic sur l'auto-amélioration récursive de l'IA, les nouvelles sanctions de la DGCCRF contre SHEIN, les risques liés aux chatbots d'intimité, les inquiétudes autour de Doctolib et des données de santé, ainsi que la nouvelle stratégie open source européenne.

Gérard Haas et son équipe ont compilé pour vous les actualités clés afin de vous permettre de rester à jour sur les dernières tendances et évolutions des secteurs juridique et numérique.

The access conditionality under Article 56a has shifted from an incentive (“carrot”) to a penalty (“stick”) — Member States can request marketing authorization holders (MAH) to launch and supply products...

On 20 April 2026, the Dutch government published a draft Implementation Act setting out the national governance structure for AI supervision under the AI Act.