Ethical and legal framework for AI applications in drug development of ‘utmost importance’

At Lygature, we see it as our responsibility to share our knowledge and think about how to further develop public-private partnerships in general, and in our areas of focus in particular. That’s why we answered to the request by the US FDA to provide input on their discussion paper ‘Using Artificial Intelligence and Machine Learning in the Development of Drug & Biological Products’ (PDF).

‘With AI technology more and more available to researchers and product developers, it becomes of utmost importance to ensure a proper ethical and legal framework for application’, says Olenka van Ardenne. She is leading the HPE Portfolio (Health law, Privacy and Ethics) at Lygature. Different legislation and guidance documents are currently being drafted in several jurisdictions. ‘Therefore, and in order to fully and responsibly reap the benefits of the technology, we believe that further alignment and potential harmonization of guidance worldwide is essential.’

This is why Lygature’s input for the FDA paper focused on the international aspect of the discussion, highlighting the very likely scenario that data acquisition for development and application of AI will happen in cross-border activities. This requires legislators and regulators worldwide to implement similar or at least compatible elements of accountability, traceability, privacy and ethical aspects in an AI code.

The installment of advisory boards such as the EU’s high-Level expert group on AI, with the inclusion of members of other jurisdictions, should facilitate such alignment between boards and expert panels. ‘Only when legislation and guidance is compatible and preferably harmonized throughout the different jurisdictions data sets, results and application will truly impact the health of citizens all over the world’, Van Ardenne concludes.