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
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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 to share monetary and non-monetary benefits at
UK MHRA Announces Consultation on the Indefinite Recognition of CE-marked Medical Devices
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
EU Court Confirms No Presumption of Confidentiality for Member State Votes: Covington Prevails in Case C‑540/23 P
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
The 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
Germany 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 affect the prices of the
German 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 Strategy.
I. The Pharma &
ABS Enforcement Expected in Spain: Spain Adopted a National Plan to Enforce Access and Benefit-Sharing Rules
On November 5, 2025, the Spanish Ministry for Ecological Transition and Demographic Challenge (“MITECO”) adopted a Resolution setting out the National Plan for the control of compliance with access and benefit-sharing (“ABS”) obligations under Regulation 511/2014 implementing the Nagoya Protocol in the European Union. The National Plan sets out a “risk-based” control system to ensure
UK Launches Food Safety Guidance for Cell-Cultivated Foods
The UK has published its first food safety guidance for cell-cultivated food products (“CCPs”). So far, the UK authorities have addressed two issues:
- First, the guidance confirms that the authorities will treat CCPs produced using animal cells as products of animal origin. Producers of CCPs from animal cells must therefore follow the existing hygiene and
European Commission Adopts Proposal for the Biotech Act
Introduction
On 16 December 2025, the European Commission (“Commission”) published its Proposal for a Regulation on establishing a framework of measures for strengthening the Union’s biotechnology and biomanufacturing sectors particularly in the area of health (“Biotech Act”) (see here). The Proposal follows a public consultation held between August 2025 and November 2025 (see here