Mette-Marie Henrichsen

I am a life science regulatory and compliance partner based in Copenhagen. I help life science companies protect innovation, navigate regulatory complexity and maintain their license to operate across Danish and EU regulatory frameworks. My expertise covers medicinal products, medical devices, emerging health technologies, cosmetics, food and food supplements.

With extensive experience in life sciences regulation, I help clients navigate the full spectrum of legal compliance challenges across the value chain, from early development and clinical trials to market access and post-market activities, ensuring they maintain their licence to operate. My assistance spans regulatory and marketing compliance for medicinal products, medical devices, cosmetics, food, and dietary supplements, including issues such as clinical trial set-up (including approvals and related contracts), pricing, reimbursement, substitution, off-label issues, parallel import and interactions with healthcare professionals. I also support clients on digital health and AI projects, in this rapidly evolving regulatory landscape.

The sector is currently undergoing significant regulatory change, notably through the forthcoming EU Pharma Package, the ongoing evaluation of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), the proposed EU Biotech Act, and the implementation of the EU AI Act, the latter particularly being relevant to the medtech industry given the increasing use of AI-enabled devices.

My work combines advisory expertise with practical experience in contracts, disputes, litigation, and M&A support, enabling me to contribute strategically to complex transactions and the interpretation of new EU and Danish regulatory frameworks.Clients value my ability to anticipate industry trends, build lasting relationships, and lead cross-disciplinary teams to deliver solutions that are both compliant and commercially sound. I actively build bridges across legal disciplines, which is essential in a sector where multiple overlapping horizontal regulations intersect. Whether working with local or global pharmaceutical, medtech, cosmetic or food companies, biotech innovators, or start-ups, I aim to provide clear, actionable advice that supports growth and mitigates risk.

Beyond regulatory matters, I have experience in enforcing intellectual property rights, including patents, trademarks, and copyright, as well as general marketing law, including injunctions and preservation of evidence cases. I regularly advise on the intersection of patent and regulatory matters, including generic or biosimilar market access and the protection of patent rights. I co-authored the third edition of the Danish book 'Life Science Jura', reflecting my commitment to thought leadership in this sector.

Denmark's life sciences clients are increasingly international, operating across multiple jurisdictions and facing complex cross-border regulatory challenges. By combining my Danish and EU expertise with Bird & Bird's integrated global platform, I can provide coordinated, consistent advice across jurisdictions.