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
The European Commission (“Commission”) has launched a four-week feedback period — open until June 3, 2026 — on a draft delegated act to revise the European Sustainability Reporting Standards (“ESRS 2.0”). Ultimately, EU companies in scope of the EU’s Corporate Sustainability Reporting Directive (“CSRD”) will have to draft their annual
Continue Reading European Commission Publishes “ESRS 2.0” for Public Consultation: Draft Closely Follows EFRAG’s Technical Advice with Additional Simplifications for Companies
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 TextTomorrow, 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?
On January 8, 2026, Brazil published Law 15,330/2026, officially recognizing açaí berry as a Brazilian national fruit in a bid to protect it from so-called “biopiracy”, i.e., the illegal exploitation of genetic resources and traditional knowledge (“ATK”). Açaí berry is a ‘superfood’ rich in nutrients which grows almost
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 Companies
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a targeted consultation on the indefinite recognition of the CE-mark for medical devices placed on the market in Great Britain (“GB”) (i.e., England, Scotland and Wales) (the “Consultation”), which will run until 10 April 2026. The Consultation aims to complement wider planned reforms to the UK medical device regulatory framework that are expected to be announced later this year. The Consultation applies to GB only as medical devices placed on the Northern Ireland market must comply with the EU medical devices framework and be CE-marked in any event.
The Consultation follows an earlier public consultation on pre-market regulatory changes for medical devices and in vitro diagnostic (“IVD”) devices (see our prior blog post here), where the MHRA announced its intention to further consult on the indefinite recognition of CE-marked medical devices in GB.
Continue Reading UK MHRA Announces Consultation on the Indefinite Recognition of CE-marked Medical DevicesIn short
On February 5, 2026, the European Court of Justice (ECJ) dismissed the European Commission’s appeal in Case C-540/23 P, confirming the Judgment of the General Court in Case T-201/21, Covington & Burling and Van Vooren v Commission.
The Court confirmed that Member States’ votes when adopting administrative
Continue Reading EU Court Confirms No Presumption of Confidentiality for Member State Votes: Covington Prevails in Case C‑540/23 PIntroduction
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 SectorLast 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 Work