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
This is one in a series of Inside EU Life Sciences blogs on the European Commission’s (“Commission’s”) latest proposal for a European Biotech Act.
On 16 December 2025, the Commission announced a proposal to introduce a new draft Regulation (“Proposed Regulation”) aimed at boosting the EU’s competitiveness in the biotech
Continue Reading European Biotech Act: Potential new extension for supplementary protection certificates (SPCs) for ATMPs and biotechnology medicines
This is one in a series of Inside European Life Sciences blogs on the proposal for an EU Biotech Act in the form of a regulation that the European Commission released on 16 December 2025. This blog focuses on the proposals to amend the EU’s clinical trial rules and establish
Continue Reading The Proposed EU Biotech Act Aims to Accelerate and Streamline Procedures for the Approval of Clinical Trials and Combined Studies
The European Commission announced today (16 December) its plans to simplify the existing EU regulatory framework for medical devices and in vitro diagnostic medical devices (“IVDs”). Many industry stakeholders have criticized the current EU device rules as being slow, costly, unpredictable, and unnecessarily complex. Under the proposed revisions, the Commission
Continue Reading European Commission Announces (Long Awaited) Proposal to Simplify EU Medical Device Regulations
At just after 5 am on 11 December 2025, the EU Parliament and the Council reached agreement on a new directive and a new regulation that will result in a major update to the EU’s pharmaceutical laws. Progress towards these new rules began in 2016 and are the result of
Continue Reading EU Announces Political Agreement on Pharma Law ReviewOn September 17, 2025, the German Supervisory Authorities (Konferenz der unabhängigen Datenschutzaufsichtsbehörden des Bundes und der Länder, DSK) published new guidelines and recommendations addressing the complex requirements for transferring personal data, particularly health data (including health data contained in biomaterials), to countries outside of the European Economic
Continue Reading New German Guidelines on GDPR Requirements for International Transfers of Health Data in Medical Research
On July 7, 2025, the European Commission presented its Roadmap Towards Nature Credits, setting the blueprint for biodiversity certification in the EU. The Communication was also accompanied by a Q&A and a call for feedback by 30 September 2025.
In short, nature credits
Continue Reading An EU Biodiversity Market by 2027? The new EU’s Roadmap towards Nature CreditsOn March 5, 2025, the Regulation on the European Health Data Space (“EHDS”) was published in the Official Journal (see here). The text enters into force on March 25, 2025, however it only becomes applicable in a staggered manner over several years.
The section on secondary use of the
Continue Reading European Health Data Space PublishedOn 15 January 2025, the European Commission published an action plan on the cybersecurity of hospitals and healthcare providers (the “Action Plan”). The Action Plan sets out a series of EU-level actions that are intended to better protect the healthcare sector from cyber threats. The publication of the Action Plan follows a number of high-profile incidents in recent years where healthcare providers across the European Union have been the target of cyber attacks.
Continue Reading European Commission Publishes Action Plan on Cybersecurity of Hospitals and Healthcare Providers