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”
Inside EU Life Sciences
Updates on Legal Developments in the EU Life Sciences Industry
Latest from Inside EU Life Sciences
The Proposed EU Biotech Act: New Biosecurity Rules for Artificial Intelligence and Biotechnology Companies
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…
New UK Guidance Clarifies Medical Device Status of AI Scribes
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…
What does the GKV-BStabG Reform Change for Pharma Pricing & Reimbursement in Germany? And the Reforms Are Not Over: What to Expect From the New German Minister of Health and the Pharma Dialogue?
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…
The Numbers Are In: What Financing has the Nagoya Protocol Delivered for Biodiversity After a Decade?
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…
Brazil delays SISGEN 3.0 Foreign-User Functionality while Government Advances alternative pathway for foreign ABS Compliance
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…
EU Biotech Act II: One Week Remaining to Shape the Commission’s Approach
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,…
The World Health Organization’s Emerging Pathogen Access System: Implications for Commercial Infectious Disease R&D
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…
U.S.–UK Pharmaceutical Pricing Agreement: Learnings from the Published Text
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…
Germany plans significant cuts in drug pricing and reimbursement – How would the GKV-Beitragssatzstabilisierungsgesetz impact pharmaceutical companies?
I. Background – From Pharma-Dialogue to Compulsory Price Cuts
Tomorrow, on 29 April 2026, the German Government is expected to adopt a new law to stabilize the finances of the statutory health insurances. This draft law titled “GKV-Beitragssatzstabilisierungsgesetz” (GKV-BStabG) proposes manifold cost-containment measures that would also significantly impact pharmaceutical companies. As such, the new law…