Life Sciences Law Update

1. Pharma Updates 

• EU: The European Medicines Agency (EMA) is launching the European Shortages Monitoring Platform to monitor medicine supply and demand, aiming to prevent, detect, and manage shortages in the EU and EEA. A pre-launch on 28 November 2024 will provide initial functionalities for Marketing Authorization Holders (MAHs), and starting 2 February 2025, MAHs must exclusively use the platform to report shortages and availability issues. EMA has issued an information letter outlining the platform’s scope, objectives, and implementation timeline.
• EU: The European Commission has introduced the Clinical Patient Management System 2.0. A system that supports cross-border medical collaboration on rare diseases. Funded by EU4Health, it enables remote consultations, fosters innovation, and allows Member States to develop national systems, reducing patient travel and enhancing healthcare.
• Germany: The Medicinal Research Act, effective from 30 October 2024, aims to strengthen Germany's position as a hub for pharmaceutical and medical device research, approval, and production has been enacted. Part of a broader strategy adopted in December 2023, the law introduces amendments to several key regulations, including the Medicinal Products Act and Social Code Book Five. Three key aspects are among others:
  •  New standard contractual clauses for clinical trials shall be issued, covering critical areas such as intellectual property rights, publication rights, liability, and data privacy. 
  • A positive influence on the reimbursement price of innovative medicinal products if a significant portion of clinical trial participants is sourced from test centers in Germany. 
  • The permission for pharmaceutical companies to negotiate confidential reimbursement prices for innovative drugs under specific conditions. 
• 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 in the midst of a major reform and design process of fundamental issues, including revision of the general framework applicable to pricing and reimbursement of medicinal products, health technology assessment, early access to medicinal products, all accompanied by important initiatives by the regulator, mainly in the context of clinical trials, and a recently approved and published Pharmaceutical Industry Strategy 2024-2028.

• Italy: On 20 August 2024 two new guidelines were published in the Official Gazette:
  • the Guideline on Regulatory Simplification and Decentralization for the conduct of clinical trials, providing clarifications on the organizational aspects of clinical trials, such as the use of third-party service providers and the possibility of delivering investigational medicinal products directly to the patients, to ensure that the provisions contained in the (EU) Regulation, or those not expressly prohibited in the EU context, are correctly applied in Italy.
  • the Guideline for the classification and conduct of observational studies on medicines was published, providing key elements for the proper classification of such clinical studies and specific instructions on the regulatory process for the submission of these studies. This Guideline replaces the former guideline issued in 2008. 

2. Medical Device Updates

• EU: On 23 October 2024, the European Parliament adopted a resolution highlighting the urgent need to revise the MDR and the IVDR and calling on the European Commission to propose secondary legislation by the end of Q1 2025 to address the challenges and bottlenecks in the implementation of these Regulations.
• EU: The European Commission published an updated Q&A on 10 December 2024, clarifying the reporting requirements under Article 10a MDR and IVDR for anticipated interruptions or discontinuations of device supply. It addresses key points such as applicable obligations, covered devices, notification timelines, and the definition of "interruption or discontinuation."
• Medical Devices Coordination Group published new guidance:
  • MDCG 2024-12 on Corrective and preventive action plan assessment
  • MDCG 2024-11 on the qualification of in vitro diagnostic medical devices
  • MDCG 2023-1 Rev. 1 Q&A on vigilance terms and concepts as outlined in the MDR and IVDR
• Italy: With two rulings published on 24 July 2024, the Italian Constitutional Court affirmed the legitimacy of the payback mechanism for medical devices, the legislative instrument through which the amount exceeding the spending cap for the purchase of medical devices by Italian Regions shall be partially borne by companies supplying them. The Italian Constitutional Court also established that all companies are entitled to reduce their payment to 48% of the original amount. 
• UK: A new consultation has been opened for future pre-market requirements and seeks views on key policy issues such as the international reliance route, a new classification system for in vitro medical devices, and whether UKCA marking requirements should be relaxed. A Roadmap for Future Medical Device Regulations has been published by the Medicines and Healthcare products Regulatory Agency, which sets out its updated approach to reforming the regulation of medical devices in the UK and confirms that we can expect the pre-market regulations to be passed into law and take effect in early 2026. Medical device companies will also need to look out for the passing into law of new regulations on post-market surveillance requirements, which were laid before Parliament in October 2024 and are expected to take effect in summer 2025. 

• Germany: The implementation of the Corporate Sustainability Reporting Directive (CSRD) remains delayed in Germany despite the EU Commission initiating infringement proceedings in September 2024. Concerns over administrative burdens and the governing coalition's breakup have stalled progress, making it unlikely for CSRD reporting requirements to apply in Germany for the 2024 reporting year.

• Spain: Spain's Council of Ministers approved the Corporate Sustainability Reporting Bill in November 2024, aligning national laws with EU Directives and raising company size thresholds for reporting obligations. Key features include additional sustainability reporting requirements for listed companies, mandatory verification of sustainability information, climate risk assessments incorporating double materiality, and transitional provisions for verifier appointments. The reporting will be phased in between 2025 and 2029, starting with large public interest entities and extending to SMEs and foreign subsidiaries. Final approval by the Spanish Congress and Senate is still pending.
• UK: The UK has introduced reforms to non-financial reporting under the Companies Act 2006, increasing financial thresholds for micro, small, and medium-sized companies by 50% for financial years starting on or after 6 April 2025. Employee thresholds remain unchanged, and large company classifications are unaffected. The reforms also streamline directors' reports by removing redundant requirements and include transitional provisions for applying the new thresholds to previous financial years.

• EU: The European Commission has identified six high-risk sectors for corruption in EU Member States: healthcare, finance, public procurement, defense and security, construction and infrastructure, and sports. During the 2nd plenary meeting of the EU Network Against Corruption, public procurement, construction and infrastructure, and healthcare were highlighted as the most vulnerable areas. The Commission intends to prioritize actions targeting these sectors to combat corruption effectively.
• Germany: Transparency Germany criticized delays in enacting the Federal Transparency Act, essential for combating corruption and restoring trust. While reforms like the March 2024 update to the Lobby Register Act and improvements to the Integrity Watch Germany platform are positive, Germany remains near the bottom in Europe for freedom of information. The lack of a “lobby footprint” to track lobbyist influence in legislation is a key shortfall.

• UK: On September 1, 2025, the corporate offence of "failure to prevent fraud," introduced by the Economic Crime and Corporate Transparency Act 2023 (ECCTA), will take effect. The UK Government published guidance detailing a "reasonable fraud prevention procedures" defence. Under ECCTA, large organizations can be held criminally liable if an employee, agent, subsidiary, or "associated person" commits fraud intending to benefit the organization, unless reasonable prevention measures were in place. The offence applies to UK-based companies and foreign companies if the fraud occurred under UK law.

On 1 December, Teresa Ribera started in her role as Executive Vice-President for a Clean, Just and Competitive Transition. In addition to handling the EU’s sustainability efforts and delivering on the EU Green Deal, Ribera is also responsible for the competition portfolio. Amongst the areas that she will focus on are developing a new EU State aid framework (with a focus on energy and clean tech), reviewing the merger control guidelines (in particular with regard to dealing with so-called “killer acquisitions”), strengthening and speeding up competition enforcement, and continued enforcement of the Digital Markets Act. Her appointment comes amidst the renewed focus of the European Commission to strengthen Europe’s competitiveness in the face of climate change, artificial intelligence and geopolitical tensions.