A European Perspective #1 | The EU’s largest pharmaceutical law reform in over 20 years introduces a new regulatory exclusivity framework, revised orphan drug incentives and an antimicrobial voucher. Strategic exclusivity planning will become essential for pharmaceutical companies.
更多A European Perspective #1 | The Commission’s proposed MDR/IVDR reform introduces substantial changes to certification, classification and compliance frameworks. Medical device companies should assess potential im-pacts early and prepare for a shifting regulatory landscape.
更多A European Perspective #1 | 2026 will be an integration year for AI in the healthcare sector. The AI Act will enter its implementation phase, while the Digital Omnibus introduces targeted simplifications. For life sciences companies, this means structurally aligning AI governance, data protection and product regulation.
更多A European Perspective #1 | EU Biotech Act: Faster Clinical Trial Approvals Ahead | The European Commission’s proposed Biotech Act aims to streamline clinical trial procedures, shorten approval timelines, and harmonise data protection rules across the EU. If adopted, the reform could significantly accelerate multinational clinical research in the EU.
更多A European Perspective #1 | AUSTRIA | The Austrian Constitutional Court holds that preventive egg retrieval without medical indication falls within the protection of Article 8 ECHR. A blanket prohibition is disproportionate; the legislature must introduce a new regulatory framework by 31 March 2027.
更多A European Perspective #1 | FRANCE | The French Supreme Court confirms a broad interpretation of commercial agent status. A key ruling increasing requalification risks and potential termination indemnity exposure for manufacturers and distributors.
更多A European Perspective #1 | GERMANY | The Frankfurt am Main Regional Court confirms: No reduction in the burden of proof (presumption of causality) pursuant to Section 84 (2) of the German Medicines Act (AMG) for IMP (not even by analogy) and no liability on the part of the sponsor in the event of (insufficient) risk information provided by the investigating physician.
更多A European Perspective #1 | HUNGARY | From 1 January 2026, Hungary allows controlled access to anonymised data held in its national digital health infrastructure for AI development. This may create new opportunities for life scienc-es innovation, while raising complex ethics, privacy and compliance questions.
更多A European Perspective #1 | POLAND | The CJEU has found Poland’s prohibition on pharmacy advertising incompatible with EU law, effectively rendering the current provision unenforceable. Companies should monitor upcoming legislative changes and reassess promotional strategies in the interim.
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