Implementing EU Rules on Clinical Trials, Medical Devices and HTA

• Jurisdiction: European Union
• Year: 2024

Speaker

Maarten Meulenbelt is the head of Sidley’s Global Life Sciences practice in Europe, specializing in EU regulatory affairs, litigation, and competition law for the life sciences sector. With a focus on the entire product life cycle, Maarten advises companies and industry associations on new EU legislation, including the Pharma Review and Patent Package.

An experienced litigator, Maarten has represented clients before the EU Courts, European Commission, national agencies, and competition authorities. His expertise spans complex cases related to pricing, access to infrastructure, and regulatory data protection. He has been instrumental in securing significant rulings on market access for drug and device companies, ensuring compliance with EU laws, and challenging restrictions on online sales and advertising.

Maarten also actively supports clients in navigating state aid disputes, trade policy matters, and the evolving regulatory landscape in the EU. His work includes addressing digital protectionism in the life sciences sector and advocating for compatibility between competition law and EU regulations. With significant experience in cross-border matters, he provides strategic guidance to clients aiming to safeguard their market positions and regulatory compliance across Europe.

Topic

The presentation provides an in-depth analysis of the implementation of EU rules on clinical trials, medical devices, and health technology assessment (HTA). Delivered by Maarten Meulenbelt at the ERA Annual Conference on EU Law in the Pharmaceutical Sector 2024, it highlights key regulatory updates, challenges, and opportunities for stakeholders in the life sciences industry.

A key focus is the EU Clinical Trials Regulation (CTR), including mandatory use of the Clinical Trials Information System (CTIS) for new applications and transitional provisions for ongoing trials. Meulenbelt discusses the interplay between GDPR and CTR regarding data...