EFPIA states AI rules must “enable not hinder” pharma R&D

AI brain

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has supported the use of artificial intelligence (AI) to deliver benefit for patients, life science companies and society, in response to the EU Artificial Intelligence (AI) Act.

The AI Act, which bans certain AI applications that it feels threaten citizens’ rights, was approved in the European Parliament in March 2024.

Significantly for drug discovery, ‘scientific research and development’ is excluded from the scope of the Act, though this will be defined further in future guidance.

In a statement, the EFPIA said AI will have an ever more critical role in the research, development and manufacturing of medicinal products, allowing the discovery, development and delivery of new, safer, more effective treatments to patients faster than ever before.

The Federation added: “It is critical that the regulatory frameworks governing the use of AI in research, development and manufacture must be fit-for-purpose, risk-based, non-duplicative, globally aligned, and adequately tailored. This would ensure that rules enable, rather than hinder, the development of safe and effective treatments that reach patients faster and more efficiently.”

The EFPIA supports the European Medicines Regulatory Network’s (EMRN) considered approach to AI, which builds on existing methods, good research practices, and requirements applied to other drug development tools (such as traditional statistical methods and approaches including model informed drug development).

Considerations for governance of AI

EFPIA said the following five considerations are critical for the use and governance of AI across the medicine development lifecycle:

  1. The EU AI Act exemption for AI dedicated to scientific research

EFPIA believes that this exemption applies to AI-based drug development tools used in the research and development of medicines because the sole use of these tools is in the R&D of medicines development.

  1. The majority of AI uses in the development of medicines do not qualify as high-risk AI under the current EU AI Act

The majority of use of AI in medicine research and development typically involves AI enabled software that is not regulated under any of the legal frameworks outlined in Annex I (including those for medical devices) nor are they featured under Annex III high risk uses.

  1. The area of medicines development is already a highly regulated space in Europe

EFPIA believes that these existing EU legal frameworks, in addition to other regulatory frameworks and policies for medicines set standards to ensure a high level of public health protection. They are sufficiently flexible to create the right foundation to include AI uses in the development of medicines.

  1. Upcoming EMA guidance on the use of AI in medicines development lifecycle will provide a new layer of AI oversight to complement the existing regulatory and legislative landscape for medicines

EFPIA believes that this upcoming AI guidance, that factors in potential risks associated with use of AI, in conjunction with established, well-functioning legislative and regulatory frameworks for medicines, will ensure appropriate governance of AI use in the development of medicines.

  1. The ultimate goal for governance of AI should be fit-for-purpose, risk-based guidance for oversight which is calibrated to the regulatory status and context of use

The pharmaceutical industry needs dynamic, flexible, future-proof guidance which takes into account the specifics of intended uses and context, and includes appropriate human oversight.

Diana Spencer, Senior Digital Content Editor, DDW

Related Articles

Join FREE today and become a member
of Drug Discovery World

Membership includes:

  • Full access to the website including free and gated premium content in news, articles, business, regulatory, cancer research, intelligence and more.
  • Unlimited App access: current and archived digital issues of DDW magazine with search functionality, special in App only content and links to the latest industry news and information.
  • Weekly e-newsletter, a round-up of the most interesting and pertinent industry news and developments.
  • Whitepapers, eBooks and information from trusted third parties.
Join For Free