The EU AI Act and its Impact on the Medicinal Product Lifecycle
The EU’s AI Act received much fanfare when it was adopted earlier this year as it heralded the first comprehensive legislation to regulate artificial intelligence (AI) anywhere in the World. Whilst the Act itself is a done deal, the focus now turns to the effective implementation of the Act and its wider application. The Act takes a risk-based approach to the application of AI to different types of use and comes into force in stages-reflecting the risk-based categorisation of AI systems. The impact on pharmaceutical and MedTech companies is expected to be significant, not least because the Act will not just apply to organisations in the EU but also to those who deploy AI in any Member State, so many global companies will be caught by its provisions.
As pharmaceutical companies fully assess the impact of the AI Act on the lifecycle of their medicinal products, The European Federation of Pharmaceutical Industries and Associations (EFPIA) has issued a statement setting out five key considerations, which it believes to be critical for the use and governance of AI across the medicinal product lifecycle, providing some clarity for pharmaceutical companies. These include:
1. Exemption for AI dedicated to research and development
EFPIA has confirmed that it considers an exemption in the AI Act will apply to AI-based drug development tools because the sole use of these tools is in the research and development of medicines. The exemption excludes from the scope of the Act AI, systems and models specifically developed and put into service for the sole purpose of scientific research and development (Articles 2(6) and 2(8)).
2. Most AI uses in medicines development do not qualify as high-risk AI under the AI Act
Even if the above-mentioned exemption did not apply, EFPIA considers that the majority of uses of AI in medicines research and development do not legally qualify as high risk under the AI Act, as they are neither listed under the Annex III high risk uses or regulated under the legislation listed in Annex I of the Act. It is worth noting that AI systems qualifying as medical devices could however still be caught as a high-risk system under the Act.
3. Medicines development is already highly regulated in the EU
EFPIA believes that existing legal frameworks for medicines already set appropriate standards to ensure a high level of public protection, whilst encouraging innovation and facilitating access to and use of medicines. EFPIA considers these same legal frameworks are sufficiently flexible to create the right foundation to include AI uses in the development of medicines.
4. New EMA guidance will add additional governance
EFPIA acknowledges the work the European Medicines Agency (EMA) is doing to prepare guidance on the use of AI in the medicine lifecycle and believes this guidance together with existing legislative frameworks will provide appropriate governance of AI use in the development of medicines.
5. Finally, EFPIA acknowledges that the “ultimate goal for the governance of AI should be fit-for-purpose, risk-based guidance for oversight which is calibrated to the regulated status and context of use” and it will continue to work with the European Commission , EMA and the wider European Medicines Regulatory Network (EMRN) as well as other relevant stakeholders as AI policy evolves, to ensure good governance, safety and ethical principles.
Although the impact of the AI Act is significant therefore, it is important to be aware of industry specific developments. Below we include some key references for further information:
Europe
EMA – draft reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle (first published 19 July 2023)
EMA/Heads of Medicines Agencies (HMA) – Artifical intelligence workplan to guide use of AI in medicines regulation (first published 18 December 2023; last updated 25 January 2024)
Artificial Intelligence Act adopted text
United Kingdom
UK Medicines and Healthcare products Regulatory Agency (MHRA) – Policy Paper – Impact of AI on the regulation of medical products (published April 2024)
We are continuously monitoring the developments in the governance of Artificial Intelligence, and what this means for our sector. Please do not hesitate to contact us if you require any assistance in preparing for the implementation of the AI Act, and watch out for our Consultants Forum on June 6th, where we will be exploring this topic further.