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
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
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 exclusively along the Amazon River, and
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 to share monetary and non-monetary benefits at
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
In 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 EU acts are not subject to