EU Cloud and AI Rules must not create barriers for European pharma, EFPIA warns
EFPIA cautiously welcomed the EU’s Cloud and AI Development Act but warns that sovereignty rules could prove counterproductive
EFPIA, Europe’s federation of pharmaceutical industries and associations, has cautiously welcomed the European Commission’s proposed Cloud and AI Development Act (CADA), backing its drive to expand European computing capacity while warning that pursuing technological sovereignty could create new barriers to research and innovation.
However, EFPIA’s support for CADA comes with a significant caveat: European sovereignty must not become European isolation. Pharmaceuticals operate globally and cloud computing technologies are already embedded across the medicines lifecycle, from drug discovery and clinical trials to manufacturing, safety monitoring and real-world evidence generation.
The association is particularly concerned that sovereignty requirements could drift towards data localisation or restrict pharmaceutical companies’ access to established global cloud and AI providers. Drug development, it argues, is inherently international, involving research institutes, regulators, hospitals, technology partners and manufacturing sites across multiple jurisdictions.
EFPIA is concerned that and measures that constrain cross-border data processing or access to global technologies could lead to fragmentation and make Europe less, rather than more, competitive.
EFPIA is calling for sovereignty requirements to remain risk-based, proportionate and technology-neutral. While tighter requirements may be justified for certain public-sector or national-security applications, the industry group argues they should not automatically extend to pharmaceutical R&D, clinical development, manufacturing, pharmacovigilance or evidence generation without a clearly demonstrated risk.
There is also concern about regulatory overload, with CADA joining an already crowded landscape encompassing the AI Act, GDPR, Data Act, Data Governance Act, NIS2, Cybersecurity Act, European Health Data Space and pharmaceutical legislation. EFPIA is urging policymakers to ensure that rules do not overlap or create contradictory requirements.