The European Federation of Pharmaceutical Industries and Associations (EFPIA) underlines the potential benefits of employing Artificial Intelligence (AI) in advancing patient care, fostering innovation, and benefiting society at large.
In a recent statement, EFPIA emphasized the crucial role AI is playing in revolutionizing the research, development, and manufacturing processes of medicinal products, ultimately enabling the discovery, development, and delivery of safer and more effective treatments to patients in a quicker timeframe than ever before.
The statement stressed the necessity for regulatory frameworks governing the utilization of AI in medicine development to be both fit-for-purpose and risk-based. Such frameworks should avoid duplication, align globally, and be tailored appropriately to ensure they facilitate rather than hinder the development of safe and effective treatments. EFPIA highlighted that the majority of AI tools used solely for medicinal research and development are exempt from the requirements of the EU AI Act, and those that aren't typically do not fall under high-risk categorization.
Additionally, EFPIA expressed support for the European Medicines Regulatory Network's (EMRN) approach to AI, which integrates AI methodologies into existing practices and standards. The federation anticipates collaborating with EMRN on forthcoming guidance for AI usage in medicine development.
EFPIA outlined five critical considerations for the governance of AI throughout the medicine development lifecycle:
1. The exemption for AI dedicated to scientific research under the EU AI Act.
2. The majority of AI applications in medicine development not qualifying as high-risk under current regulations.
3. The already stringent regulatory environment governing medicine development in Europe.
4. The upcoming guidance from the European Medicines Agency (EMA) on AI use in medicine development.
5. The necessity for adaptable, risk-based governance calibrated to the specific context and intended use of AI systems.
As the AI policy landscape evolves in Europe, including the finalization of the EU AI Act and the ongoing work of EMRN, EFPIA is committed to collaborating with relevant stakeholders to ensure responsible AI implementation while upholding fundamental rights, safety, and ethical principles.
The final text of the AI Act establishes a comprehensive framework for AI systems in the EU market, categorized by risk. EFPIA's engagement with EMA aims to clarify AI usage and governance in the medicine development lifecycle, aligning with the Act's risk-based approach.
