Takeaways from the EU Pharma Law Forum 2024

Bristows was delighted to sponsor and attend this year’s EU Pharmaceutical Law Forum, which was held in Brussels at the Steigenberger Wiltcher’s Hotel back in May.

The Forum ran from 21-23 May and delivered a host of fascinating presentations and panel discussions from leading figures in private practice and from the pharmaceutical industry. The Forum was attended by Sean-Paul Brankin, Jamie Hatzel and Xisca Borras from Bristows. 

The first day was dedicated to discussion of competition law, patents and SPCs in the pharmaceutical sector. The second day was dedicated to pharmaceutical regulatory developments, while the third day’s presentations were split into two concurrent streams: the first stream on commercial transactions and the second on healthcare data, privacy and compliance. 

Key themes

It would be difficult to distil three days of detailed discussion into just a few paragraphs. Presentations ranged across a diversity of legal topics, which included:

• regulatory reform in the EU in relation to pharmaceuticals, cell and gene therapies and substances of human origin,
• private enforcement of regulatory exclusivities in Europe, 
• developments in pricing and market access, and
• various considerations relating to the conduct of clinical research in the EU.

A particular highlight in the latter category included a thought-provoking talk which Xisca delivered in conjunction with Simone Heitz (Senior Legal Counsel at Merck), entitled “Striking a Regulatory Balance for Companion Diagnostics: Analysing Tensions Between Pharmaceutical and IVDR Frameworks”.

Notwithstanding the breadth of discussion at the Forum, there were some key themes which arose repeatedly throughout.

The first was ensuring that Europe remains globally competitive in attracting R&D investment. This was a topic of particular importance in discussion of the EU’s proposed package of pharmaceutical regulation reform, which is currently in trilogue at the EU institutions. Pernille Weiss (MEP for Denmark and rapporteur on the pharmaceutical regulation reform directive) highlighted the need for strong incentives to draw investment to the EU, particularly in underserved areas such as antimicrobial resistance. Kristine Peers (General Counsel at EFPIA) highlighted EFPIA’s Mind the Gap campaign, which has drawn attention to the investment gap between the EU and the United States (25€ billion in 2022, and still widening). Kristine also warned against punitive measures which could deter investment. For example, she expressed fears that the currently proposed reforms could lead to companies being compelled to launch their products throughout the EU at a price imposed by EU Member States.

The second was the impact of artificial intelligence and digital technologies on all aspects of the pharmaceutical industry in Europe. Some talks addressed these technologies directly, discussing matters such as the EU’s recently adopted Artificial Intelligence Act, the European Health Data Space Regulation, and the various position papers which have been adopted by pharmaceutical regulators in relation to the use of AI in industry operations, particularly as regards pharmacovigilance and GxP activities. In other talks, artificial intelligence lurked in the background like a particularly zeitgeisty elephant in the room, as when George Pickering (VP Legal at GSK) discussed the benefits and challenges of using digital technologies to gather clinical data in decentralised clinical trials.

One particularly interesting use case of artificial intelligence which arose at the Forum was the use of generative AI (such as ChatGPT or Gemini) to cheaply and rapidly produce marketing materials which are compliant with the complex regulatory requirements for medicines advertising. We are already aware of clients who operate secure localised instances of generative AI systems and use these to generate routine documents such as emails and meeting agendas. Given the cumbersome and expensive processes which most life sciences companies currently implement to produce and approve marketing materials, and the rate of progress in generative AI (such that we now see generative AI capable of producing convincing synthetic video content), it seems only a matter of time before AI-generated marketing materials become widespread.

Conclusion

The Forum gave delegates a fantastic opportunity to connect with each other in person and to disconnect from their work devices for a few hours. It was great for the Bristows team to see so many familiar faces at the Forum and to make new connections with other attendees as well. We enormously enjoyed our time in Brussels this year and are already looking ahead to the next Forum in 2025!