The programme
The new EU Pharmaceutical Legislation is set to influence the future of research, development, and manufacturing in Europe for years to come. This evolving regulatory landscape brings new rules, new challenges, and plenty of opportunities. As we face these forthcoming changes, we brought together perspectives from leading voices in academia, public institutions and the pharmaceutical industry to explore the following topics:
- New framework for regulatory data protection and market exclusivity
- Tackling medicinal product shortages and ensuring supply security
- The European Health Data Space
- New developments in medicinal product advertising
Key takeaways:
We kick-started the event with a discussion on the new framework for regulatory data protection and market exclusivity with a presentation by Peter Bogaert (Covington & Burling LLP) and a comprehensive overview of the pharmaceutical legislation’s impact on patent law by Márk Kovács (Schoenherr Attorneys at Law). Moderated by Lluís Alcover (Faus Moliner), this session explored in more detail orphan market exclusivity, compulsory licenses, the Bolar exemption and the challenges introduced by the new pharmaceutical legislation.
Facilitated by Alessandro Spina (European Commission), the second session focused on one of the most pressing concerns: medicinal product shortages. Machteld Hiemstra (Simmons & Simmons) highlighted the objectives of the new legislative package and its strategies for addressing shortages and supply disruptions, while Oliver Hartmann (AESGP) shared valuable insights from the European self-care industry’s perspective.
In our third session on the European Health Data Space, Gabriela Lenarczyk (University of Copenhagen (Københavns Universitet)) introduced the context and objectives of this new initiative, highlighting its key provisions and implications for intellectual property, particularly in the context of clinical trials. Oliver M. Brupbacher (Bär & Karrer) addressed bottlenecks in health data exchanges, cross-border data transfers, and consent requirements, and Delphine Marchal (Eli Lilly and Company) explored the challenges and opportunities posed by the EHDS for pharmaceutical companies. Under the guidance of the session Chair, Martin Dræbye Gantzhorn (Gorrissen Federspiel), the panel addressed both regulatory challenges and innovative opportunities in this evolving area.
The conference concluded with a session on advertising of medicinal products. Vincenzo Salvatore (Simmons & Simmons) provided an update on recent developments in advertising regulations, while Diane Bandon-Tourret (LexCase Société d’Avocats) presented on OTC claims in France, sharing practical examples of pre-authorization processes, influencer laws, and other country-specific nuances. Moderated by Andreas Natterer (Schoenherr Attorneys at Law), the session explored the current rules, anticipated changes under the new package, and key takeaways for the industry.
