EFPIA Statement on the use of AI

The European Federation of Pharmaceutical Industries and Associations (“EFPIA”) has issued a statement on the use of artificial intelligence (“AI”) in the medicinal product lifecycle in the context of the EU AI Act, a proposed regulation that aims to ensure the safety and ethical use of AI in the EU. EFPIA believes that AI has great potential to improve research, development and manufacturing of medicines, and that the existing regulatory frameworks for medicines are sufficient and flexible enough to accommodate AI-based tools. EFPIA also supports the exemption of AI systems and models that are solely used for scientific research and development from the scope of the EU AI Act and argues that most of AI uses in medicines development are not high-risk and should not be subject to additional requirements.

EFPIA welcomes the European Medicines Regulatory Network's (“EMRN”) approach to AI, which builds on existing methods, good research practices, and requirements applied to other drug development tools. EFPIA looks forward to collaborating with the EMRN on upcoming guidance for the use of AI in medicines development, which will provide a new layer of AI oversight to the existing regulatory and legislative landscape for medicines. EFPIA believes that the ultimate goal of governance of AI should be fit-for-purpose, risk-based guidance that takes into account the specifics of intended uses and context and includes appropriate human oversight. EFPIA highlights five key considerations for the use and governance of AI in the medicine development lifecycle:

·             The exemption of AI systems and models for scientific research and development from the scope of the EU AI Act.

·             The non-qualification of most AI uses in medicines development as high-risk under the EU AI Act.

·             The existence of a well-established regulatory framework for medicines development in Europe that ensures the safety and efficacy of medicines and encourages innovation.

·             The upcoming guidance from the European Medicines Agency (EMA) on the use of AI in the medicines lifecycle, which will provide a new layer of AI oversight to the existing regulatory and legislative landscape for medicines.

·             The need for dynamic, flexible, future-proof guidance that takes into account the specifics of intended uses and context and includes appropriate human oversight.

EFPIA members are committed to working with the European Commission, the EMA, the broader ERMN, patient groups and other stakeholders in the healthcare space to ensure that AI is used in a way that benefits patients, life-science companies and society, while adhering to fundamental rights, safety and ethical principles. EFPIA considers that the EU AI Act supports innovation and freedom of science and should not undermine research and development. It also calls for global alignment and non-duplication of AI rules to avoid fragmentation and barriers to innovation.