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
Continue Reading 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?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.
Continue Reading The Numbers Are In: What Financing has the Nagoya Protocol Delivered for Biodiversity After a Decade?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
Continue Reading EU Biotech Act II: One Week Remaining to Shape the Commission’s ApproachThe 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
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
Continue Reading U.S.–UK Pharmaceutical Pricing Agreement: Learnings from the Published TextGermany 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.
Continue Reading Germany plans significant cuts in drug pricing and reimbursement – How would the GKV-Beitragssatzstabilisierungsgesetz impact pharmaceutical companies?Navigating the new UN High Seas Treaty: Key Compliance Risks for Life Sciences Companies
On January 17th, 2026, the Biodiversity Beyond National Jurisdiction (“BBNJ”) Agreement, also known as the “High Seas Treaty”, entered into force. For the first time, companies that use marine genetic resources (“MGRs”) and digital sequence information (“DSI”) originating from areas beyond national jurisdiction may be required
Continue Reading Navigating the new UN High Seas Treaty: Key Compliance Risks for Life Sciences CompaniesThe Biotech Act Recognises and Supports “Strategic Projects” And “High Impact Strategic Projects” to Reinforce the Union Biotechnology Sector
Introduction
As discussed in our previous blogpost (link), on 16 December 2025, the European Commission (“Commission”) released its Proposal for the European Biotech Act (“Biotech Act”) (see here).
This blogpost focuses on Chapter II of the Proposal (“Union Health Biotechnology and Biomanufacturing”), which introduces a framework for the recognition of “health biotechnology strategic projects” (“Strategic Projects”) and “high impact health biotechnology strategic projects” (“High Impact Strategic Projects”), together with a package of regulatory and support measures aimed at accelerating their development and deployment in the Union.
Continue Reading The Biotech Act Recognises and Supports “Strategic Projects” And “High Impact Strategic Projects” to Reinforce the Union Biotechnology SectorGermany changes rules for Digital Health Applications (DiGA) – More Reporting, More Transparency, More Work
Last week, Germany’s Federal Ministry of Health has adjusted the rules governing Digital Health Applications (DiGA) once more. Key changes include new reporting obligations that require manufacturers to measure and document the success of their digital health apps. This reform adds notable operational pressure, while the reported outcomes will directly
Continue Reading Germany changes rules for Digital Health Applications (DiGA) – More Reporting, More Transparency, More WorkGerman Government launches new Pharma & MedTech Dialogue – Broad agenda, big hopes but unclear prospects
Germany has kicked off a new Pharma and MedTech Dialogue that aims to develop new policies and regulatory reform proposals to re‑establish Germany as a competitive, innovation‑friendly location for life sciences R&D and manufacturing. The outcome of this dialogue shall be the basis for a new German Pharma and MedTech
Continue Reading German Government launches new Pharma & MedTech Dialogue – Broad agenda, big hopes but unclear prospects