EFPIA Issues Statement on Application of the AI Act in the Medicinal Product Lifecycle

On April 22, 2024, the European Federation of Pharmaceutical Industries and Associations ("EFPIA") issued a statement on the application of the AI Act in the medicinal product lifecycle. The EFPIA statement highlights that AI applications are likely to play an increasing role in the development and manufacture of medicines. As drug development is already governed by a longstanding and detailed EU regulatory framework, EFPIA stresses that care should be taken to ensure that any rules on the use of AI are fit-for-purpose, adequately tailored, risk-based, and do not duplicate existing rules. The statement sets forth five "considerations":

1. R&D AI qualify under the AI Act's research exemption

The AI Act does not apply to AI systems and models developed and put into service solely for scientific research purposes. Accordingly, the exemption should encompass AI-based drug development tools used in research and development, as that is their sole use.

2. Other R&D AI generally not "high risk"

AI systems and models used in the research and development of medicines that do not fall under the exemption should not be considered high-risk AI, as they generally do not satisfy the criteria for "high risk" AI systems set forth in Article 6 of the AI Act.

3. No need for additional regulation of R&D AI

The development of medicines in Europe is already subject to an intricate set of very detailed rules and regulations in Europe. This regulatory system should suffice to also address the use of AI in the development of medicines, without the need for additional regulation.

4. The European Medicines Agency (EMA) expected guidance is welcome

EFPA welcomes the EMA's efforts to assess the impact of AI in R&D, such as in its consultation on a draft reflection paper and multi-annual work plan, and its emphasis on a "risk-based" approach. This existing regulatory framework should be able to tackle any concerns related to AI in the development of medicines.

5. R&D AI governance should be calibrated to its context

Finally, the EFPIA statement points out that AI regulation should remain flexible in order to keep pace with technological development, but should also be able to adapt to the different contexts in which it is applied, including the relevant stage of a product's development, its impact on the risk-benefit analysis of a medicine and the applicable level of human oversight. Collaboration among all stakeholders concerned should help to ensure that the potential of AI can be unlocked while respecting fundamental rights, safety and ethical principles.

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