Survey exposes knowledge gap surrounding AI legislation, with a fifth of respondents confirming regulations are blocking their research 

The Pistoia Alliance, a global, not-for-profit alliance that works to lower barriers to innovation in life sciences and healthcare R&D, has announced the results of a global survey of life science professionals on the impact of emerging AI regulations for pharma R&D. Just 9% of respondents said they know EU and US AI regulations well, with more than a third (35%) having no understanding at all. The survey also revealed the top three challenges preventing life science organizations from keeping up with legislation. Complexity and ambiguity of regulations was the most cited (37%), followed by too many different regulations across regions (23%), and insufficient collaboration between industry and regulatory bodies (20%). The survey was conducted as part of the Alliance’s commitment to overcome the barriers to AI adoption through collaboration, under its 2024 strategic priorities.

“From our Lab of the Future Report we know AI is top of our members’ investment agendas but our new research highlights legislation is a major barrier to adopting AI successfully. We must bridge the gap between life sciences, technology companies, vendors, and legislators to harness AI in a secure and compliant way to accelerate vital health research,” comments Dr Christian Baber, Chief Portfolio Officer of the Pistoia Alliance. “The Pistoia Alliance is perfectly placed to create a forum for discussing the ambiguity and complexity of regulations as they arise. Our Artificial Intelligence and Machine Learning Community of Experts acts as a crossroads between experts in data science, pharma, regulatory bodies and government, and has already made great strides in accelerating AI adoption in life sciences. We now encourage more technology, compliance, and pharma experts to come forwards to join the community, and express interest in our new AI initiatives.”

21% of respondents said existing regulations are blocking their research. Respondents also shared the areas they believe should be prioritized when governments are drafting new AI regulations. The top considerations were patient data privacy and security, and ethical guidelines and bias, cited by 57%. Currently, 31 countries have passed AI legislation and 13 more are debating AI laws. Most recently the EU and the US announced new legislation and an executive order respectively. The EU’s AI Act will be one of the world’s most stringent and will be particularly relevant to pharma due to the bloc’s large market size and tendency to set standards that other regions follow. The EU rules are based on AI’s potential risk and level of impact to consumers. High risk applications such as medical devices, drug manufacturing and diagnostic AI will require conformity assessments, while limited risk applications such as chatbots must be clearly labelled as AI tools.

“AI is new territory for both legislators and pharma companies that we must navigate together. Our members have raised a number of concerns regarding emerging legislation. From ambiguities surrounding risk categories, to challenges around data and AI governance, and the use of synthetic data to train future algorithms,” comments Dr Vladimir Makarov, Project Manager of the Pistoia Alliance AI and ML Community of Experts. “The Pistoia Alliance panel of experts will discuss how legal changes may affect research and allows pharma companies to get involved at the regulatory level. This research gives us a strong baseline to understand members’ current concerns, share back to the regulators, and shape our future discussions and projects.”

The Pistoia Alliance invites representatives from pharma, technology, and regulatory bodies to get involved in its AI and ML Community of Experts to further discuss evolving regulations and their impact on drug discovery and development research. It is also looking to the industry for support in funding this initiative.

This survey was conducted among 125 life science professionals during a February 2024 webinar on EU and US AI regulation and the impact on pharma R&D, run by the Pistoia Alliance. The survey is available here.

About The Pistoia Alliance

The Pistoia Alliance is a global, not-for-profit members’ organization made up of life science companies, technology and service providers, publishers, and academic groups working to lower barriers to innovation in life science and healthcare R&D. It was conceived in 2007 and incorporated in 2009 by representatives of AstraZeneca, GSK, Novartis, and Pfizer who met at a conference in Pistoia, Italy. Its projects transform R&D through pre-competitive collaboration. It overcomes common R&D obstacles by identifying the root causes, developing standards and best practices, sharing pre-competitive data and knowledge, and implementing technology pilots. There are currently over 200 member companies; members collaborate on projects that generate significant value for the worldwide life sciences R&D community, using the Pistoia Alliance’s proven framework for open innovation.