EFPIA welcomes the European Commission's proposal for a Regulation establishing a framework of measures to strengthen Europe's cloud and AI ecosystem (Cloud and AI Development Act – CADA). Advanced computing capacity, secure cloud infrastructure and artificial intelligence are increasingly important enablers of biomedical innovation and are used throughout the medicines lifecycle, from drug discovery and clinical development to manufacturing, pharmacovigilance and real-world evidence generation. 

The proposal reflects the growing importance of cloud computing, data infrastructure and AI as strategic drivers of Europe's competitiveness, innovation capacity and technological leadership. Strengthening Europe's computing capabilities and digital infrastructure can accelerate scientific discovery, support industrial innovation and improve Europe's attractiveness for investment. 

EFPIA supports the overall objective of increasing Europe's ​own ​computing capacity, fostering AI adoption and reducing barriers to digital innovation. At the same time, implementation of the proposal must preserve the openness, interoperability and global connectivity that underpin ​global ​pharmaceutical research and development. 

The proposal's ambition to expand Europe's computing capacity and support investment in cloud and AI infrastructure could deliver significant benefits for the life sciences sector. Increased access to high-performance computing resources, AI Factories, advanced cloud services and research infrastructure can accelerate scientific research ​through​​​ the development, validation and deployment of innovative AI applications​ in the pharmaceutical sector​. These investments can support more efficient drug discovery, improve clinical trial design and execution, optimise manufacturing processes and strengthen evidence generation throughout the medicinal product lifecycle.  

The proposal may also create important synergies with the European Health Data Space (EHDS). Improved cloud infrastructure and interoperable digital capabilities can support the secure secondary use of health data and enable AI-driven biomedical research, regulatory science, epidemiology, pharmacovigilance and real-world evidence generation. 

Key considerations: 

Maintaining a risk-based and technology-neutral approach to sovereignty 

EFPIA recognises the objective of strengthening Europe's resilience and reducing critical dependencies in cloud and AI infrastructure. However, any sovereignty framework should remain strictly risk-based, proportionate and technology-neutral. While Level 3 assurance - under the Union cloud computing sovereignty framework proposed in CADA - mandates European ownership and control, providers from recognised associated third countries may also qualify. In developing the forthcoming implementing act, the Commission should ensure that the eligibility framework for third countries remains sufficiently flexible and risk-based to reflect the global nature of research and innovation, rather than relying on a static list of pre-designated countries. The pharmaceutical sector operates through highly integrated global research, development and manufacturing networks. Companies routinely collaborate with international research institutions, regulators, healthcare providers, technology partners and manufacturing sites across multiple jurisdictions. Sovereignty requirements must therefore not become de facto data localisation measures or create unnecessary barriers to collaboration with trusted international partners or the use of established global cloud and AI providers. 

Measures that limit access to globally available technologies or constrain legitimate cross-border data processing could fragment research operations, increase compliance costs, reduce access to best-in-class technologies and ultimately weaken Europe's attractiveness as a location for innovation and investment. While specific sovereignty requirements may be justified for certain public sector or national security use cases, they should not be extended to pharmaceutical R&D, clinical development, pharmacovigilance and post-authorisation safety monitoring, manufacturing or evidence-generation activities without a clear and demonstrated risk basis. 

Ensuring regulatory coherence 

The Cloud and AI Development Act will become part of an already complex​ European​ regulatory ​and legislative ​landscape that includes the AI Act, EHDS, the Data Act, the Data Governance Act, NIS2, the Cybersecurity Act, GDPR and sector-specific pharmaceutical legislation. 

EFPIA therefore urges policymakers to ensure strong alignment across these frameworks using international standards and avoid overlapping, duplicative or conflicting requirements. Regulatory coherence, including on the assurance levels, Member States will be required to establish, is essential to provide legal certainty, facilitate compliance and support investment in innovative technologies. The Cloud and AI Development Act should simplify and enable digital transformation rather than create additional layers of fragmented obligations. 

Conclusion 

EFPIA supports the ambition of the Cloud and AI Development Act to strengthen Europe's cloud and AI ecosystem and enhance the Union's competitiveness, innovation capacity and digital resilience. 

To maximise its benefits, the final framework should: 

• strengthen access to advanced cloud and AI infrastructure; 

• support data-driven scientific research and innovation; 

• maintain a risk-based, proportionate and technology-neutral approach to sovereignty; 

• avoid barriers to global scientific collaboration and pharmaceutical R&D activities; 

• ensure coherence with existing EU digital, data and pharmaceutical legislation. 

The EU's objective should be to build a stronger and more resilient cloud and AI ecosystem that remains connected and interoperable with global innovation networks. The Cloud and AI Development Act can support EU competitiveness by strengthening infrastructure, improving access to AI capabilities and providing legal certainty, while preserving the openness, interoperability and global connectivity essential for pharmaceutical innovation and patient benefit.