The Q2/24 Life Science and Health Care Law Update covers key trends in the EU and Big Five (France, Germany, Italy, Spain, UK) in life sciences regulatory, corporate, compliance, competition, and privacy.

Key developments

• Pharma: Critical Medicines Alliance to prevent medicines shortages; Clinical Trials Information System Transparency rules revised
• Devices: New measures to prevent devices shortages; Revised guidance on drug device combinations; UK MHRA on international recognition of devices
• Corporate: Commission updates Accounting Directive Size Criteria; French law to increase financing of businesses
• Competition: Active enforcement of competition law
• Compliance: New anti-corruption legislation to unify standards across the EU; French Guideline on benefits to HCPs
• Life Science and Data Privacy: AI Act approved; Court of European Justice ruled on Health concerning Data

Pharma and updates in the EU

• European Commission launched Alliance to tackle critical medicines shortages: On 24 April 2024, the European Commission’s Health Emergency Preparedness and Response launched the Critical Medicines Alliance (CMA) to prevent shortages of critical medicines in the EU. The CMA includes authorities, industry, health care organizations, and civil society, aiming to enhance supply security and reduce dependencies. CMA will make strategic recommendations, identify investment projects, and explore market incentives.
• Clinical Trial Information System Transparency rules (CTIS) revised: On 18 June 2024, the EU has launched a new version of the CTIS to implement the updated transparency rules for the CTIS. It allows earlier and more efficient access to information about authorized clinical trials including a public searchable database for health care professionals, patients, and the general public.
• The European Medicines Agency (EMA) has updated its pre-authorization guidance to include the Joint Clinical Assessment (JCA) process: Initially, JCA will cover new cancer treatments and advanced therapy medicinal products, with orphan drugs and others included by 2030.

Device Updates in the EU

• Measures to prevent medical devices and In Vitro Diagnostics (IVD) shortages will enter into force soon. The rules extend the transition periods for certain IVDs, enable a gradual roll-out of the European database on medical devices (EUDAMED) database, and require manufacturers to notify authorities of potential shortages of critical devices.
• EMA published revised guidance addressing practical considerations for drug-device combinations: Updated Q&A clarifies issues related to changes in the medicinal component, including when a new or updated opinion from a Notified Body might be required for the device component.
• The Medical Devices Coordination Group (MDCG) recently released two new guidance documents:
  • Guidance on the content of the Investigator’s Brochure (IB) for clinical investigations of medical devices (MDCG 2024-5).
  • Guidance on the clinical evaluation of orphan medical devices (MDCG 2024-10), outlining criteria to determine when a medical device or its accessory qualifies as an “orphan device”.

Continue reading… national pharma and device updates