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Impact of the new Biotech Act on Clinical Trials in the EU
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.
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Ban on “social egg freezing” declared unconstitutional
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.
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Promotional activities for medical devices may qualify as agency even without direct negotiation power
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.
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Advising on Infinitopes' expanded seed financing to US$35 million
Advising Nuclera on its extended Series C funding to US$87 million
Biotechnology as a security issue: Why dual-use control and adaptive regulation are crucial for national sustainability
Guidance to manufacturers withdrawing a medical device from the EU market
Medical product availability and healthcare safety are becoming increasingly important talking points. This is also reflected in the EU regulations on medical devices. Although the provisions may seem straightforward their vagueness may give rise to significant doubts as to which situations they will apply to in practice.
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Comparison of national measures to protect the supply of medicines and medical devices
Our international team has developed a practical guide that allows users to navigate different European jurisdictions, identifying medicines subject to supply restrictions, and understand manufacturers' obligations during shortages or product withdrawals.
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EU and medicines supply issues (part one): Current measures
Marketing Authorisation Holders (MAHs) in the EU are legally required to report medicine supply shortages to the European Medicines Agency and national authorities. This article explores the central role of Marketing Authorisation Holders (MAHs) in identifying and managing medicine supply shortages in the EU as well as the role of EMA committees and working groups in coordinating responses and maintaining the Critical Medicines List to safeguard public health.
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