18 December 2025Publication
EU regulatory shifts for HLS in 2026
2026 will see several important legislative reforms and new initiatives that are expected to shape the sector’s operations and strategic priorities.
With such significant challenges facing the sector, our clients turn to us to help them navigate the legal decisions that need to be made.
Falling R&D productivity coupled with increasing generic competition and parallel imports are putting pressure on operators. Coupled with a reduction in government healthcare budgets, closer regulatory and investor scrutiny, and an increasing focus on drug safety - it's a constant challenge to grow and stay ahead of the competition.
Growth is being hindered as a result of fewer drugs reaching blockbuster status and this is placing an even greater emphasis on patent protection. It also means that drug pipelines are increasingly reliant on product/company acquisitions, licensing and collaborations to maintain earnings and reduce portfolio risks.
We work with our clients in this sector to help them address a wide range of legal requirements.
Our experience
Eli Lilly
Eli Lilly in its patent revocation proceedings involving those relating to Olanzapine.
GlaxoSmithKline
The successful representation before the French Supreme Court in cases involving the Hepatitis B vaccine.
Bayer
Advising Bayer in litigation involving patents relating to Bayer’s female oral contraceptive products in the UK, Germany and the Netherlands.
Key contacts
If you have any questions, contact a member of the Pharmaceuticals team for assistance:
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