Life Sciences Law Update

A. Life science regulatory

1. Pharma updates

• EU: On 10 April, the European Parliament adopted its position on a major reform of the EU pharmaceutical legislation—the most extensive overhaul in over 20 years. The reform seeks to enhance the system's agility and responsiveness to public and industry needs by improving medicine availability, accessibility, and affordability; supporting innovation; and increasing the competitiveness of the EU pharmaceutical industry, while also promoting higher environmental standards. Key objectives include:
  • Strengthening the Single Market to ensure equal access to safe and affordable medicines across the EU;
  • Creating a research- and innovation-friendly environment for pharmaceutical development;
  • Reducing administrative burdens and accelerating authorisation processes to get medicines to patients faster;
  • Combating antimicrobial resistance (AMR) through incentives like transferable vouchers for novel antibiotics and promoting responsible antimicrobial use;
  • Enhancing the environmental sustainability of medicines;
  • The proposals will now move to the European Parliament and the Council for further consideration;
• Germany: As reported in our last Life Science Law Update, the Medical Research Act has introduced key reforms to enhance Germany’s appeal for clinical research. Highlights include: (i) faster approvals, (ii) streamlined procedures for trials involving ionizing radiation (from July 2025), (iii) centralized review by a new ethics committee (since 1 July 2025), (iv) standard contract clauses, and (v) confidential reimbursement options (available since January 2025, but unused as of 30 June). A draft bill was approved by the cabinet on 28 June and is under Federal Council review, with possible finalization around 11 July. Stakeholders support the reforms but flagged transitional and confidentiality concerns.
• France: In France, clinical trials involving human subjects must be governed by a mandatory template agreement. This template has been published by the French Ministry of Health in August 2024 has been recently updated. The modifications are designed to align the template with contemporary clinical research practices, ultimately facilitating faster contract negotiations with research centers. However, while the new templates establish standards, they may still be too general and not fully adapted to the increasingly sophisticated protocols and techniques employed by the pharmaceutical industry. Consequently, any company planning to initiate clinical trials in France must carefully review the new template and evaluate any potential gaps between it and their own standard Clinical Trial Agreements or those used by their contract research organizations for these trials.
• UK: The statutory instrument to amend the Medicines for Human Use (Clinical Trials) Regulations 2004 was laid before Parliament, and if passed into law will introduce greater flexibility for low-risk clinical trials, as well as fewer approval requirements for these kinds of trials, enhance transparency requirements and sunset periods on clinical trial authorizations (amongst other changes). These regulations are expected to come into force in early 2026.
• Spain: Spain is still in the midst of a major reform and design process of key issues, including revision of the general framework applicable to medicinal products, price and reimbursement of medicinal products, or health technology assessment, all accompanied by important rulings issued by the Spanish courts, particularly in terms of promotion of authorized medicinal products prior to price and reimbursement decision or confidentiality of the industry price and reimbursement conditions of medicinal products.
• Italy:
  • Starting on 9 February 2025, Italy will replace the traditional pharmaceutical “bollino” sticker with the GS1 DataMatrix code on prescription medicines, in compliance with EU Regulation 2016/161. Italy has introduced an extra security label, to improve traceability and prevent fraud. A transitional period of two years has been established.
  • AIFA’s 2024 report highlights a shift toward digital pharmaceutical advertising (69% of submissions) and a high volume of activity (13,438 materials). However, 28.5% of submissions were non-compliant, revealing ongoing issues with promotional accuracy. The report confirms AIFA’s key role in oversight but signals the need for stricter industry and regulatory controls.

2. Medical device updates

• EU: New Medical Devices Coordination Group (MDCG) published new guidance:
  • Medical device apps on online platforms. On 16 June 2025, a new guidance document MDCG 2025-4 on the safe making available of medical device software (MDSW) apps on online platforms was published. This guidance aims to describe the obligations of app platform providers and their respective responsibilities under the MDR and/or /IVDR, as well as the Digital Services Act.
  • Interplay between the MDR/IVDR and the AI Act. On 19 June, a new guidance document, MDCG 2025-6 on the Interplay between the MDR and the IVDR, and the AI Act, was published. This guidance document provides a first set of answers to the most frequently asked questions related to the joint application of the AI Act and the MDR or IVDR for manufacturers.
• EU: In response to ongoing discrimination against EU medical device companies in China's public procurement market, the European Commission has decided to exclude Chinese medical device companies from EU public contracts exceeding EUR 5 million. This measure, stemming from the first investigation under the International Procurement Instrument, aims to pressure China to end its discriminatory practices. Additionally, if Chinese companies do win contracts, their share of inputs must not exceed 50%.
• EU: On 28 May 2025, European Commission began a public consultation on joint clinical assessments for medical devices and IVDs under the EU HTA Regulation, open until 25 June 2025. Additionally, from 2 to 30 June 2025, Commission opened the second submission period for Joint Scientific Consultations, offering guidance to health technology developers on evidence and study planning for future assessments.
• Italy: On 7 May 2025, the Tribunale Amministrativo Regionale del Lazio upheld the legitimacy of Italy’s payback mechanism for medical devices, stating that the law was sufficiently clear since 2015 and that companies should have anticipated its enforcement. On 20 June 2025, the Italian Government approved a new decree, according to which suppliers of medical devices can resolve their obligations by paying 25% of the requested amount, with no further legal actions allowed.
• UK: New regulations for decentralized manufacturing (DM) of medicines, specifically focusing on point-of-care (POC) and modular manufacture (MM), were signed into law on 23 January 2025 and with a 6-month implementation period to 23 July 2025. POC involves products made at or near their use location due to specific requirements, while MM involves self-contained units for rapid deployment, such as pandemic vaccines. Manufacturers wanting to use DM models will need to apply to the MHRA for decentralised manufacturing designation, which confirms that a product meets the legal criteria for POC or MM. To obtain designation, applicants will need to justify their need for a decentralized approach based on the relevant legal tests and providing supporting quality and clinical data. To support these regulatory changes, the MHRA has published seven guidance documents covering several key areas: Applying for DM designation, the procedure for obtaining marketing authorization for the DM, the clinical trial authorization (CTA) for DM, good pharmacovigilance practices, the application of good manufacturing practices (GMP) for DM, and labelling requirements.

B. Corporate governance & corporate social responsibility

• Germany: Germany: On 1 April 2025, the Law to Strengthen the German Judiciary (Justizstandort-Stärkungsgesetz) entered into force pursuant to which inter alia the Federal States now have the possibility to establish Commercial Courts at the Higher Regional Courts which may serve as courts of first instance (thereby skipping the Regional Courts as regular first instance) for (i) commercial disputes (except for those in the field of industrial property rights, copyright and claims under the Act against Unfair Competition), (ii) post M&A litigation and (iii) disputes between a legal entity and its members of the executive or supervisory board. They also offer the possibility to conduct the proceedings in English language. The legislator expects that via Commercial Courts – similar to arbitration proceedings – complex international commercial disputes can be conducted efficiently, in English language and with the necessary expertise.
• Spain: Spain's RDL 1/2025 reinstates and extends the transitional foreign investment screening regime until 31 December 2026. During this period, non-EU/EFTA investors must obtain prior authorization for foreign direct investments meeting all of the following conditions:
  • Acquisition of 10% or more of a Spanish company’s share capital or gaining control.
  • The target is either: A listed company with shares traded in Spain, or an unlisted company with a transaction value over €500 million.
  • The target operates in a strategic sector (e.g., health, defence, critical infrastructure, or public security).

Companies involved in cross-border deals should assess applicability and prepare necessary filings accordingly..

• Italy: Italy’s 2025 Budget Law introduced a new obligation for directors of Italian companies to obtain and register a personal certified e-mail address (PEC) with the Companies’ Register. A PEC has the same legal value as a registered letter with return receipt. Following initial uncertainty, the Ministry for Enterprises and Made in Italy (MIMIT) clarified on 12 March 2025 that this requirement applies to all directors, including those of already incorporated companies, and that company PECs cannot be used. While the Milan Chamber of Commerce disputed the filing deadline for existing directors, MIMIT later confirmed on 25 June 2025 that the deadline for PEC registration is extended to 31 December 2025. The obligation applies clearly in cases of:
  • New company incorporations;
  • Director appointments or confirmations;

Failure to comply may result in suspension or rejection of relevant corporate filings.

• France: France’s Order No. 2025-229 (12 March 2025) reforms the company law nullity regime to secure corporate decisions and simplify rules. Key changes include:
  • Stricter conditions for nullity (grievance, influence, proportionality tests) and limits on cascading effects;
  • Shortened limitation period (2 years instead of 3, except for capital increases);
  • Reclassification and clarification of provisions in the Civil Code and alignment with EU law;
  • New rules for SAS allowing nullity based on internal rules;
  • Most provisions take effect 1 October 2025; one CSRD-related rule applies from 1 January 2027.
• UK: On 25 February 2025, the Crime and Policing Bill was introduced to Parliament, proposing significant reforms to criminal law. A key element is the expansion of corporate criminal liability: Companies and partnerships could be held liable for any criminal offence committed by a senior manager acting within their actual or apparent authority.This new statutory route does not replace the existing common law identification doctrine, which ties liability to individuals representing the “directing mind and will” of a company. Instead, it complements it by broadening liability beyond economic crimes—superseding provisions from the Economic Crime and Corporate Transparency Act 2023, which applied only to economic offences.

C. Anti-bribery & anti-corruption

• Germany: Annual Report of association "Voluntary Self-Regulation for the Pharmaceutical Industry e.V." published: In its annual report, the German association "Voluntary Self-Regulation for the Pharmaceutical Industry" (Freiwillige Selbstkontrolle für die Arzneimittelindustrie e.V. – FSA) looks back on 2024. The report gives a detailed overview of the thematic focal points of the association's work and reports on the decisions of the FSA arbitration board in the wording.
• UK: The Economic Crime and Corporate Transparency Act 2023 introduces a new strict liability offence for "failure to prevent fraud" targeting large organizations, defined as those meeting two of the following criteria: over 250 employees, more than £36 million turnover, or over £18 million in total assets. Effective from on 1 September 2025, the only defense is having reasonable procedures to prevent fraud. The Act also broadens corporate criminal liability for economic crimes by expanding the "identification principle," allowing liability to be attributed to senior managers, not just top executives. This change is expected to have a significant impact, potentially more so than the new fraud prevention offence.

D. Competition & antitrust (EU)

The Belgian Competition Authority (BCA) is increasing scrutiny on the pharmaceutical sector, with a particular focus on biosimilars and drug shortage: The BCA also announced plans to issue a communication about information exchange in relation to combination therapies. During the EU Pharmaceutical Law Forum on May 20 2025, the BCA announced they will closely monitor pharma companies in cases where their practices might hamper the availability of essential medicines for Belgian patients, as well as when they might unlawfully coordinate drug placement.

E. Data privacy (EU)

European Commission adopts extension for adequacy decision for the United Kingdom: On 24 June 2025, the European Commission adopted its implementing decision for an extension of the adequacy decision for the United Kingdom. The adequacy decision for the United Kingdom, originally adopted in June 2021, was set to expire on 27 June 2025 due to a built-in sunset clause. The Commission now adopted a technical and time-limited extension of six months, until 27 December 2025, to allow for a reassessment of the UK’s data protection framework which is currently amended by the Data (Use and Access) Bill. The developments regarding the adequacy decision should be monitored, as it is not guaranteed that the adequacy decision will remain in force after 27 December 2025.

Authored by Joerg Schickert, Tom Brassington, Alex Dolmans, Jean-Marc Franceschi, Fabian Roy, Jane Summerfield, Steffen Schuppert, May Lyn Yuen, Giuseppe Aminzade, Danette Antao, Eduardo Perez, Thomas Weber, Louis-Nicolas Ricard, Álvaro Abad, Caroline Schmalenbach