Recent weeks have proved of great interest to the UK medical device industry, with various key developments emerging. Foremost among these, on 10 September 2026, the National Commission into the Regulation of AI in Healthcare (“National Commission”) published its report on recommendations for a future regulatory framework (“Report”). The Report contains 44 recommendations, including several
Hot off the press, yesterday evening, 29 September 2026, the German Government’s expert committee presented the eagerly awaited proposal for a new “location clause” (Standortklausel) to incentivize pharmaceutical R&D and manufacturing in Germany. Under this proposal, pharmaceutical companies can apply for a reduction or complete waiver of the just recently enacted 8.5% additional “manufacturer markdown”
The global biotechnology landscape is evolving at an unprecedented speed, driven by advances in synthetic biology and genome editing, which, coupled with AI, make biotechnology stand at the forefront of innovation. These developments offer unprecedented opportunities for advancing health and protecting against biological threats, but also make biotechnological misuse faster, cheaper, and more accessible. For
On 29 July 2026, the UK’s Medicines and Healthcare products Regulatory Agency (“MHRA”) (the regulatory authority with responsibility for enforcing UK medical device rules) published new guidance on ambient voice technology-enabled products (“AVTs,” also known as ambient scribing tools) (“AVT Guidance”). The AVT Guidance is intended to clarify (and essentially overrule) a decision by NHS
Tomorrow, on 30 July 2026, the “GKV-Beitragssatzstabilisierungsgesetz” (GKV-BStabG) will enter into force, marking the culmination of a fast-paced and politically contentious legislative process. The reform, which has attracted significant attention, introduces a broad package of cost-containment measures across the statutory health insurance (GKV) system. Several of these specifically target pharmaceutical spending and reimbursement and are
Bart Van Vooren and Yuliya Gevrenova
The Nagoya Protocol was adopted under the Convention on Biological Diversity (“CBD”) and is built on the idea that the commercial use of materials from nature (“genetic resources”) should translate into fair and equitable benefits for countries providing and protecting nature in their jurisdictions. For the first time since
Anderson Ribeiro, Aline Ferreira and Henryk Trelinski of Souto Correa Advogados contributed to the preparation of this article.
Foreign companies have long faced a practical challenge under Brazil’s access and benefit-sharing (“ABS”) regime: although registration obligations apply to activities involving Brazilian genetic heritage, foreign legal entities still cannot register directly in SisGen, Brazil’s
The European Commission’s Call for Evidence on the upcoming Biotech Act II is open until 10 June 2026, with one week remaining for companies to provide input. Companies should consider engaging now to help shape the outcome.
The initiative is expected to have a broad impact across sectors including chemicals, agriculture, agri-biotech, food and feed,
Over the past week, at the 79th World Health Assembly (“WHA”) in Geneva, governments have been debating one of the most consequential but still poorly understood elements of the World Health Organization (“WHO”) Pandemic Agreement that was adopted in May 2025: the Pathogen Access and Benefit-Sharing (“PABS”) System. Since then, negotiations on the PABS have
On 2 April 2026, the UK Government published text memorializing its agreement with the U.S. in relation to pharmaceutical pricing. The UK now refers to this as an “arrangement” (“U.S.-UK Pharmaceutical Pricing Arrangement”). Our blog post from December discussed the in-principle heads of terms for the deal announced in December 2025, with various details marked