Artificial Intelligence (AI) and Big Data (BD) presents an unprecedented opportunity within the framework outlined by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) to enhance quality assurance, streamline drug development processes, increase traceability at supply chain level, and ultimately improve quality and safety of medicinal products. A new report generated by the ETERNAL Research and Innovation Action discusses the ethical considerations and legislative imperatives for integrating AI and BD within the ICH guidelines to ensure responsible usage and sustainable business outcomes.

The white paper report, produced by a joint-authorial team at international Scientific, Safety and Regulatory Affairs consultancy company Asphalion and IRIS, a leading European manufacturer of photonic and artificial intelligence solutions for real-time control of industrial and production processes, describes how AI and BD have emerged in combination as a pivotal factor in the rapidly evolving landscape of pharmaceutical research and development. In the authors’ view, these digital technologies are set to become central to drug development and manufacturing processes. Such advances however, also introduce complex ethical and legislative challenges, particularly around data privacy, algorithmic transparency, and decision-making accountability, and it is crucial that these are properly assessed.

The paper aims to provide a comprehensive background into the adoption of AI and BD within the pharmaceutical sector, highlighting their novelty, laying out the objectives of their application in an ethical manner, and make a connection with the newly established AI regulatory framework endorsed  on March 13th, 2024. The new EU Act cultivates a principled and balanced framework for the utilization of AI broadly across society. It is intended to encourage the development of AI technologies that are ethical, secure, and socially advantageous, ensuring that technology proceeds in tandem with a deep-seated respect for human rights, accountability, and the collective good of society.

Integrating Artificial Intelligence and Big Data in Pharmaceutical Development: Ethical Considerations and Legislative Frameworks is a first attempt to to bridge the gap between the ICH guidelines and the ethical, conscientious deployment of AI and BD within pharmaceutical development, underscoring the urgency for adopting forward-thinking, interactive strategies in decision-making processes to steer these technological integrations within the new, robust, enhanced European legislative frameworks.

Read the full report