Q1/2025 Life Science Law Update – Key developments for pharma and medical device companies in the EU

Pharma

• New EU HTA Regulation (Effective January 2025): Joint clinical assessments for oncology, gene, and cell therapies will begin, supporting national Health Technology Assessments (HTA) processes in evaluating health technologies' clinical impact. These HTAs will influence budget allocation, pricing, and reimbursement decisions. High-risk medical devices will be included in 2026, orphan medicines in 2028, and all new medicinal products by 2030.
• EMA & EU Medicines Agencies Strategy (2025-2028): The European Medicines Agency (EMA) and Heads of Medicines Agencies have published the European medicines agencies network strategy to 2025. It focuses on improving medicine access, leveraging AI and digitalization, enhancing regulatory innovation, addressing antimicrobial resistance, and ensuring supply chain resilience. The strategy aligns with upcoming EU pharmaceutical legislation and lessons from COVID-19, aiming to strengthen EU competitiveness in medicine development and manufacturing.
• New ICH E6(R3) Good Clinical Practice Guideline: All clinical trials in the EU are now governed by the Clinical Trials Regulation. Ongoing trials must transition to the Clinical Trials Information System (CTIS).
• Proposed Critical Medicines Act: On 11 March 2025 the European Commission proposed a Regulation to improve the availability of critical medicines in the EU. This new regulation aims to strengthen EU pharmaceutical manufacturing, enhance supply chain resilience, and promote EU-based medicine production. It shall further encourage strategic investments, joint procurement, and diversification of supply sources.

Devices

• EMA Procedure for High-Risk Medical Devices: On 10 February, EMA introduced a standard procedure for manufacturers to request scientific advice on clinical development and investigations for certain high-risk devices, including Class III and Class IIb devices used to administer or remove medicinal products.
• Update to eIFU Regulation (EU) 2021/2226: The European Commission proposed amendments to extend electronic instructions for use (eIFU) to all professional-use medical devices. It also requires manufacturers to provide a permanent URL for eIFUs in the UDI database.
• Future Governance of Medical Technologies in Europe: On 19 March, six MedTech industry associations jointly called for improved governance of the EU medical device regulatory system. Their position paper cites inefficiencies in the CE marking process, leading to delays in device availability and affecting sector competitiveness.

Compliance

EU Commission presented omnibus legislation proposing changes to the CSRD and the CSDDD: The proposed amendments to the Corporate Sustainability Reporting Directive (CSRD) and the Corporate Sustainability Due Diligence Directive (CSDDD) aim to simplify compliance requirements, reduce regulatory burden, and create a more business-friendly environment. These changes are intended to support companies in meeting sustainability obligations without being overwhelmed by excessive rules. 

Competition & Antitrust

EU's competition chief Ribera promises swift antitrust guidance on green cooperation, during Forum Europe speech: Teresa Ribera has promised to provide faster guidance for companies seeking to cooperate on environmental initiatives, such as reducing their businesses' environmental impact. The guidance will focus on ensuring these collaborations align with EU antitrust rules, specifically addressing green initiatives like sustainable business practices and decarbonization efforts. While the European Commission has historically been open to such cooperation, many companies have hesitated due to fears of regulatory scrutiny and lengthy processes. Ribera's initiative aims to foster genuine green partnerships, while also adapting competition policy to modern environmental and economic challenges.

Anti-Corruption & Bribery

Rising Concerns Over Corruption in the EU – Transparency International Calls for Stronger Action: Perceived corruption in Western Europe and the EU has worsened for the second year in a row, with the regional average Corruption Perception Index score falling to 64. Major economies like Germany and France, as well as traditionally strong performers like Norway and Sweden, have seen declines. Only six of 31 countries improved, while 19 declined. Transparency International is urging the adoption of a stronger Anti-Corruption Directive, as negotiations await the new European Parliament’s position.

Intersection Of Life Science & Data Privacy

• Provisions in the EU AI Act on prohibited AI and AI literacy become applicable: The EU Artificial Intelligence (AI) Act's first provisions became applicable on 2 February 2025. This includes the AI system definition, AI literacy, as well as provisions on prohibited AI. These provisions ban AI practices posing unacceptable risks, such as manipulative techniques and unauthorized facial recognition. The European Commission also issued guidelines on prohibited AI practices.
• The EHDS Regulation has come into force: The European Health Data Space (EHDS) Regulation requires companies to comply with the European electronic health record exchange format and enhancing data subject rights under the GDPR. However, the EHDS Regulation does not have an immediate effect. Instead, it is the beginning of a process that will unfold over time. The EHDS aims to facilitate access to large-scale health data for research and innovation, providing a standardized process for accessing electronic health records across EU Member States.
• EDPB launched coordinated enforcement action regarding the right of erasure: The framework launched by the European Data Protection Board (EDPB) focuses on the 'right to erasure' under GDPR Article 17, due to frequent use and complaints. Data protection authorities will assess how data controllers handle erasure requests and apply relevant conditions and exceptions.

Authored by Joerg Schickert, Thomas Weber, Lutz Angerer, Falk Schöning, May Lyn Yuen, Stefan Schuppert.