EFPIA Statement on the Use of AI

Applications of AI


2024-04-22T17:54:00

european union

EFPIA issues statement on EU AI law and its impact on medicines lifecycle

EFPIA Statement on the Use of AI

European Federation of Pharmaceutical Industries and Associations (“EFPIA) has issued a statement regarding the use of artificial intelligence (“artificial intelligenceEFPIA highlights the importance of AI in the medicines lifecycle in the context of the EU AI Law, a proposed regulation aimed at ensuring the safe and ethical use of AI in the EU. EFPIA believes that AI has great potential to improve medicines research, development and manufacturing, and that the existing regulatory framework for medicines is sufficient and flexible to accommodate AI-based tools. EFPIA also supports excluding AI systems and models used exclusively for scientific research and development from the scope of EU AI Law, arguing that most uses of AI in medicines development are not high risk and should not be subject to additional requirements.

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

· Excluding AI systems and models for scientific research and development from the scope of EU AI law.

Under EU AI law, most uses of AI in drug development are not considered high risk.

· Europe has a well-established regulatory framework for drug development that ensures the safety and effectiveness of medicines and fosters innovation.

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

· The need for dynamic, flexible and forward-looking guidance that takes into account the specifics of the intended use and situation and includes appropriate human oversight.

EFPIA members are committed to working with the European Commission, EMA, the broader ERMN, patient organisations and other stakeholders in the healthcare sector to ensure that AI is used in ways that benefit patients, life sciences companies and society, whilst respecting fundamental rights, safety and ethical principles. EFPIA believes that EU AI law should support innovation and scientific freedom and not undermine research and development. It also calls for global harmonization of AI rules and avoid overlaps, to avoid fragmentation and barriers to innovation.



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