Life Science and Health Care Law Update Q3

A. Life Science Regulatory

1. Pharma:

• Strategy for European Life Sciences to make Europe a global leader in life sciences by 2030: On 2 July 2025, the European Commission launched a strategy aiming to make Europe the global leader in life sciences by 2030, backed by EUR 10 billion annually. It focuses on R&D excellence, advanced therapies, multinational trials, and faster market access through streamlined regulation and use of data and AI, while promoting innovation, trust, and talent development.
• New targets for clinical trials in Europe: The EU has set ambitious new targets to strengthen its clinical trial landscape, aiming to authorize 500 new multinational trials over five years and ensure that 66% of these trials begin recruiting participants within 200 days. This initiative is designed to enhance research capabilities and improve patient access to innovative treatments. Supportive measures include the Accelerating Clinical Trials in the EU initiative (ACT EU) and programs such as CTR Collaborate, COMBINE, and MedEthicsEU, which focus on improving trial design, providing guidance, and reducing administrative burdens. Between January 2022 and January 2025, the Clinical Trials Information System facilitated approximately 200 new trials per month, including 80 multinational trials, demonstrating significant progress toward a more efficient and supportive EU clinical trial ecosystem.
• EMA has published a draft reflection paper on patient experience data: The paper encourages integrating patient experienced data (PED) (i.e. patients’ direct experiences and preferences) throughout the medicine lifecycle to complement clinical evidence. It outlines general principles for PED collection and analysis, supports international harmonisation, and seeks stakeholder feedback to better align medicine development with patient-relevant outcomes. The paper is open for public consultation until 31 January 2026.
• Stakeholders warn Europe’s clinical trial ecosystem is at risk: A report by European clinical trial stakeholders warns that without fast implementation of the Life Science Strategy, Europe could lose its competitive edge. Key challenges include regulatory complexity, administrative burdens, and patient recruitment delays, pushing research to the US and China. The report calls for better regulatory alignment, streamlined frameworks for low-risk and paediatric trials, and stronger collaboration between ethics committees and regulators. Rapid action is needed to revitalize Europe’s clinical trial ecosystem and ensure timely patient access to innovative therapies.
• New variations guidelines to streamline lifecycle management of medicines: The European Commission and the European Medicines Agency (EMA) will implement new Variations Guidelines from 15 January 2026 to speed up and simplify medicine lifecycle management. Updated EMA guidance by December 2025 will cover regulatory procedures, risk-based classification, and tools like post-approval change protocols. These measures aim to ensure timely updates, maintain the benefit–risk balance, and support the EU’s broader pharmaceutical strategy.

2. Medical Devices:

• Commission Call for Evidence on MDR/IVDR revision. On 8 September 2025, the European Commission launched a Call for Evidence for the targeted revision of the MDR and IVDR, aiming to simplify the framework by reducing administrative burden, improving predictability and cost-efficiency, and safeguarding patient safety. Stakeholders can provide input until 6 October 2025 via the Have Your Say platform on issues including conformity assessment, digitalisation, governance, international cooperation, and alignment with other legislation.
• Update of Manual on borderline and classification under the MDR and the IVDR. The manual on borderline and classification was updated for the 4th time in September 2025. The new entries cover: a) the classification of red blood cell additive solutions containing adenine and dual action cream with menthol and capsaicin, and b) the qualification of lactose tablets for vaginal use, microabrasion dental stain removers, medical examination table covers and mobile sterile air system.
• New Medical Devices Coordination Group (MDCG) guidance: On July 2025, MDCG published a position paper on the timelines of implementation of Master UDI-DI to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles.

B. Corporate governance & corporate social responsibility

EU Proposes Major Simplifications and Delays for CSRD and CSDDD: Following the European Commission’s Omnibus package in February 2025, major simplifications and delays were proposed for the Corporate Sustainability Reporting Directive (CSRD) and Corporate Sustainability Due Diligence Directive (CSDDD). On 23 June 2025, the Council backed a narrower scope—raising the CSRD threshold to companies with at least 1,000 employees and EUR 450m turnover, and the CSDDD to those with at least 5,000 employees and EUR 1.5bn turnover. Other changes include a two-year delay for climate transition plans, removal of the EU-wide civil liability regime, a one-year postponement of the CSDDD deadline, and a shift to risk-based diligence. The EU Parliament was expected to finalize its position by October 2025, with trilogue negotiations to follow. However, on 22 October 2025, the Parliament unexpectedly rejected the trilogue mandate adopted by its Legal Affairs Committee (JURI) regarding simplifications for CSRD and CSDDD as a consequence of which the Parliament will now vote on amendments to the JURI proposal on 13 November 2025.

C. Competition & Antitrust:

Competition Commissioner highlights sustainability as key factor in merger assessments and market practices: The EC’s Competition Commissioner talks about the importance of sustainability to ensure a competitive environment. During a speech from September 2025, Teresa Ribera pushed for the assessment of long-term impact on sustainable development when assessing mergers and encouraged efforts to promote transparency on the hidden environmental costs of business practices. Ribera also stated that procompetitive initiatives by companies to cooperate on sustainability are welcomed and encouraged.

D. Anti-Corruption & Bribery:

• Inconsistent anti-corruption reform implementation in the EU: Recent GRECO (Group of Countries against Corruption) evaluations show that while many EU member states have introduced anti-corruption reforms in government and law enforcement, implementation is often inconsistent due to weak enforcement, limited resources, and inadequate oversight. Common gaps include low transparency, insufficient conflict-of-interest rules, poor asset disclosure, flawed police vetting, and weak whistleblower protections, with progress varying by country.
• EU delists UAE from high-risk AML list: The EU has removed the United Arab Emirates from its high-risk anti-money laundering list, despite ongoing concerns, particularly in the real estate sector, reducing mandatory scrutiny of transactions involving the country. Critics warn that serious gaps remain, and continued monitoring is needed to prevent abuse by politically exposed persons and fugitives.

E. Intersection Of Life Science & Data Privacy:

Q3 2025 was marked by developments in the area of international data transfers: The General Court of the European Union dismissed an action for annulment of the European Commission's adequacy decision regarding the EU – U.S Data Privacy Framework and in principle confirmed that – at the date of the adequacy decisions – the EU – U.S. Data Privacy Framework ensured an adequate level of data protection. Furthermore, the European Commission published its drafts for an adequacy decision for Brazil and a renewal of the existing adequacy decision for the United Kingdom. This decision can significantly impact the life sciences sector by providing greater legal certainty and enabling smoother, compliant cross-border data transfers such as for clinical trials and research. It can reduce administrative burdens and legal risks, supporting more efficient international collaboration and innovation. The development concerning the European Commission adequacy decisions should be closely monitored to ensure international data transfers are carried out in accordance with Chapter V of the GDPR.

Authored Dr. Joerg Schickert, Fabien Roy, Thomas Weber, Dr. Falk Schöning, May Lyn Yuen, and Dr. Stefan Schuppert.