Manuele Cantù

The updated composition of the Emergency Task Force (ETF) was published by the European Medicines Agency on 17 July 2025. Established under regulation (EU) 2022/123, the ETF is responsible for managing preparedness for public health emergencies. The new composition of the ETF reflects the expertise required to prepare for potential future public health emergencies of biological origin based on past experience. Additional ad hoc experts may be appointed as required in relation to other potential threats of chemical, nuclear or radiation origin.

The ETF is co-chaired by Marco Cavalieri, a staff member of the EMA appointed by the Agency’s Executive Director, and Bruno Sepodes, the Chair of the Committee for Human Medicinal Products (CHMP). The Task Force also includes the Chairs of the Pharmacovigilance Risk Assessment Committee (PRAC) and of the Paediatric Committee (PDCO), as well as representatives from several of the EMA’s committees and Working Parties. The ETF is completed by three EMA staff members, one representative each from the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) and the Clinical Trials Coordination and Advisory Group (CTAG), and two clinical trial experts proposed by the Clinical Trials Coordination Group (CTCG).

Members of the new EU Commission were announced on 17 September 2024. Hungarian Olivér Várhelyi is the new Commissioner for Health and Animal Welfare. He served as European Commissioner for Neighbourhood and Enlargement in the first von der Leyen Commission, and he previously covered various roles in the EU institutions. According to the Mission Letter, the mandate should focus on completing the EU Health Union. Among key priorities are the diversification of supply chains, strategic inventories and competitiveness. The finalisation of the review of the pharmaceutical legislation and the proposal of a Critical Medicines Act and a new European Biotech Act are among the announced lines of action. 

Bulgarian Ekaterina Zaharieva is the new Commissioner for Startups, Research and Innovation. She is member of the Bulgarian Parliament, and served as Minister of Justice (2015-2017), and as Deputy Prime Minister for Judicial Reform and Minister of Foreign Affairs (2017-2021). Among the main goals highlighted in the Mission Letter are the expansion of the European Innovation Council and the European Research Council, and the proposal of a European Research Area Act to support the free movement of researchers, scientific knowledge and technology. A European Innovation Act should support the simplification of the regulatory framework and access to venture capitals. Commissioner Zaharieva should also collaborate, among others, to the preparation of the new multi-disciplinary Strategy for European Life Sciences.

The French Stéphane Séjourné is the new Executive Vice-President for Prosperity and Industrial Strategy. He served as Political adviser to the French President (2017-2019), and as Minister for Europe and Foreign Affairs (2024). His portfolio includes also Industry, SME and Single Market. Among main goals is the setting up of a Competitiveness Coordination Tool and the development of the Clean Industrial Deal (in collaboration with the Commissioner for Climate, Net Zero and Clean Growth, the Dutch Wopke Hoekstra). Among expected actions are the proposals of a Industrial Decarbonisation Accelerator Act and the implementation of the Net Zero Industry Act, as well as the development of the future European Competitiveness Fund and the revision of the Public Procurement Directives. An EU Critical Raw Material Platform to support joint purchasing and management of strategic stockpiles is also planned.

Twelve European industrial associations, including EFPIA, MedTech Europe and COCIR in the healthcare sector, have published a joint statement to call for a major rethink of the ongoing revision of the Product Liability Directive (PLD). The main concern expressed in the document is the lack of balance in the proposed revision, that according to the associations could undermine European competitiveness and significantly raise litigation risk, legal complexity and uncertainty for European businesses. This might negatively impact on both investment in innovation and consumers. The industrial associations suggest to maintain the current framework, that led to good results  for both parties since its entry into force in 1985. Critical parts of the proposed PLD revision, wrote the associations, refer to the expanded scope to include digital products, the de facto reversal of the burden of proof, disproportionate disclosure of evidence provisions and removal of compensation thresholds.

Requests to the Trilogue, now in charged of final negotiations, include limits to the alleviation of the burden of proof, which should be significantly narrowed, and clarified as for what claimants must do and prove before any liability can be presumed. More safeguards would be needed as for the disclosure of evidence, in order to protect businesses against abusive discovery exercises or disclosure of commercially sensitive data or trade secrets. According to the associations, disclosure of evidence should be limited to only what is strictly necessary and proportionate. A greater attention should be also posed in the inclusion of software in a strict liability regime, and how to apply the concept of defectiveness. The associations agree with the EU Parliament proposal of a threshold to prevent frivolous claims.

Source: EFPIA