Key Public Policy Developments Around the World
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 medicinesOn December 2, 2025, the Court of Justice of the European Union (“CJEU”) issued a decision clarifying the obligations of online marketplace operators with regard to content posted on their platform, where such content includes personal data. This blogpost provides an overview of the decision and its key takeaways.
Continue Reading CJEU Clarifies Responsibilities Of Online Marketplace OperatorsOn 3 December 2025, the European Commission adopted the RESourceEU Action Plan, signaling that Europe’s industrial competitiveness will increasingly depend on its ability to secure and diversify critical raw material (“CRM”) supply chains. For companies, inside and outside the EU, RESourceEU is more than a technical update: it marks a policy shift toward a more interventionist and security-driven approach to CRM governance.
The analysis below outlines the drivers behind the initiative, its main components, and the implications for multinationals trading into the EU.
Continue Reading RESourceEU Action Plan – Strengthening the EU’s Access to Critical Raw MaterialsAt 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 November 19, 2025, the European Commission unveiled its 2030 Consumer Agenda, setting out priorities for EU consumer policy over the next five years. Below is an overview of the six key measures most relevant to industry.
Continue Reading European Commission Announces 2030 Consumer Policy StrategyOn 3 December 2025, the European Commission unveiled the next phase of its economic security agenda. Building on the 2023 Economic Security Strategy and the 2024 European Economic Security Package (see our prior blog), the new communication sets out a more assertive and coordinated approach to managing risks linked to trade, investment, technology and critical infrastructure.
The EU intends to remain open to trade and investment, but that openness will increasingly be conditioned on economic security objectives. For businesses and investors, this translates into more scrutiny, more due diligence, and a more integrated interplay between the EU and Member States.
Continue Reading Strengthening EU Economic Security – More of the Same or a New Approach?The Commission has issued a call for evidence in relation to its 2026 evaluation and review of the Audiovisual Media Services Directive (“AVMSD”).
The AVMSD came into force in 2010 and establishes the EU’s regulatory framework for audiovisual media services. It governs the EU level coordination of national legislation on all audiovisual media, including traditional TV broadcasts and on-demand services.
The first review of the AVMSD was carried out in 2018 and resulted in the introduction of new provisions governing video sharing platforms.
Under Article 33 of AVMSD, the Commission is required to assess the impact and added value of the AVMSD and present an ex-post evaluation report, accompanied where appropriate by proposals for reviewing the Directive, by 19 December 2026. This second review of the AVMSD is also part of the Commission’s commitments in the recently announced European Democracy Shield, which aims to foster the EU media sector to achieve stronger and more resilient democracies.
Continue Reading The European Commission calls for evidence ahead of its 2026 evaluation and review of the Audiovisual Media Services DirectiveOn 19 November 2025, the European Commission (“Commission”) officially presented its Digital Omnibus Package (see here and here). The initiative represents a comprehensive update to the EU’s digital regulatory landscape, which the Commission frames as a competitiveness and simplification initiative aimed at reducing administrative burdens and enhancing legal certainty for businesses. Although the final text is likely to evolve during negotiations with the European Parliament and the Council of the EU (“Council”), the package, if adopted in its present form, would introduce significant changes to data protection obligations, cookie rules, cybersecurity regulations and the EU AI Act.
The Digital Omnibus Package consists of two proposed regulations: a “Digital Omnibus” that would amend, amongst other legislation, the General Data Protection Regulation (GDPR), ePrivacy Directive, NIS2 Directive and Data Act, and a “Digital Omnibus on AI” that would amend the EU AI Act. We outline below key proposals from the Digital Omnibus that have particular significance for organizations operating in the EU.
A summary of amendments affecting the Data Act and the key proposals in the Digital Omnibus on AI will be addressed in subsequent blog posts.
Continue Reading European Commission Proposes Revisions to GDPR and Other Digital Rules Under Digital Omnibus PackageOn October 14, 2025, the European Data Protection Board (“EDPB”) announced that its 2026 coordinated enforcement action (“CEA”) will focus on transparency and information obligations — the rules that require organizations to clearly explain how they collect, use, and share personal data — under Articles 12-14 of the General Data Protection Regulation (“GDPR”).
Continue Reading EDPB to Focus on Transparency in 2026 EnforcementOn 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