Life Sciences & Digital Health

On November 12, 2025, UNESCO’S General Conference adopted its Recommendation on the Ethics of Neurotechnology (“the Recommendation”)–the first attempt at establishing a global legal framework for the ethical development and use of neurotechnology. The Recommendation aims to set out a comprehensive rights-based framework for the entire life cycle of neurotechnology, from the design of neurotechnology products and services to their disposal.

While not legally-binding, the Recommendation states that its provisions should be considered by, among others, UNESCO Member States, research organizations, and private companies involved in neurotechnology, and that they establish how best to honor fundamental human rights in the development, deployment and disposal of this technology. It is therefore possible that in the future, they may be a starting point for binding legislation, or could be used as persuasive authority to support enforcement actions arising under existing legislation protecting fundamental human rights, e.g., the GDPR and other privacy laws around the world. In that regard, it is notable that the EU AI Act was inspired, at least in part, on UNESCO’s November 2021 Recommendation on the Ethics of Artificial Intelligence. There is, therefore, a real possibility that private sector companies developing neurotechnologies will be subject to rules specifically regulating such technologies in the future.Continue Reading UNESCO Adopts First Global Framework on Neurotechnology Ethics

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

In a landmark judgement, the Higher Regional Court of Cologne has set new standards for pharmaceutical advertising with influencers. First, a key point from the decision is that the court qualifies paid influencers as agents of the drug company with respective consequences for the company (discussed below). Second, the court treats promotional social media reels/videos like TV ads which leads to subsequent disclosure obligations. Third, influencers can regularly qualify as “known persons” so that the restrictions under German law for drug advertising with known/famous persons can apply. Continue reading for more details on the case and its implications for pharmaceutical companies.Continue Reading Influencer Marketing – German court sets new Guardrails for Pharmaceutical Advertising on Social Media

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 Review

On 1 December 2025, the UK Government announced a “landmark” UK-US pharmaceutical deal.   Under the deal, the UK claims to be (so far) the only country to secure zero-percent tariffs on pharmaceuticals exported to the US for the next three years.  In return, the UK has committed to increase its spending on medicines and revise some of the most controversial aspects of the UK pricing and reimbursement system.

Although details as to the implementation of the deal are still unclear, it is clear this will involve major changes to the landscape for commercializing innovator drugs in the UK, after months of attritional and sometimes fractious wrangling between the industry and UK Government.Continue Reading Landmark UK-US Pharmaceutical Deal

On October 31, 2025, the Ninth Circuit struck down certain parts of USDA’s National Bioengineered Food Disclosure Standard, including the exemption for highly refined foods in which modified genetic material is undetectable. The decision remands the invalidated portions of the regulations to USDA for revision and could result in a

Continue Reading Ninth Circuit Invalidates USDA’s Exemption for Highly Refined Foods Under the National Bioengineered Food Disclosure Standard

On November 6, U.S. Senator Roger Marshall (R-KS), a member of the Senate Health, Education, Labor, and Pensions (HELP) Committee and MAHA Caucus, introduced the highly anticipated “Better Food Disclosure Act” (the “Better FDA Act”). The bill aims to close the so-called “GRAS loophole.” Although the bill, which was developed

Continue Reading Senator Marshall Proposes an Overhaul of the GRAS Framework

On 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 Area for scientific research purposes under the GDPR. These guidelines may be of particular relevance for pharmaceutical, medical device, and other life sciences companies that conduct clinical research.Continue Reading New German Guidelines on GDPR Requirements for International Transfers of Health Data in Medical Research

This alert merely summarizes the allegations contained in FDA’s letters. It does not contain any analyses, opinions, characterizations, or conclusions by or of Covington & Burling LLP. As a result, the information presented herein does not necessarily reflect the views of Covington & Burling LLP or any of its clients.

Continue Reading FDA Advertising and Promotion Enforcement Activities: Update

Germany has taken another step to improve the conditions for pharmaceutical research & development in Germany. Now, the Federal Government has adopted the “Standard Contractual Clauses” for pharmaceutical clinical trial agreements. In this blog, we discuss what the new standard clauses cover and how they will affect clinical trials in Germany.Continue Reading Germany enacts Standard Contractual Clauses for pharmaceutical clinical trial agreements – Changes for medical device studies also on the horizon