The healthcare sector is undergoing a rapid digital transformation, driven largely by the integration of Artificial Intelligence (AI). Among the areas experiencing significant change is the drug development process, where AI promises to streamline the discovery of new drugs and targets while substantially reducing costs.
The EU AI Act establishes a robust legal framework that employs a risk-based approach to regulate AI applications in healthcare, highlighting the need for rigorous oversight in early drug development stages, including drug discovery and preclinical trials. The applications of AI in drug discovery and preclinical trials are of particular interest due to their economic incentives, potential impact on downstream applications, and significant compliance and ethical challenges, all of which require strong regulatory oversight. By analyzing the EU AI Act’s risk-based classification framework, it is crucial to outline specific compliance obligations in healthcare sector with a particular focus on early drug development phases that vary according to the risk level of the AI systems used, ranging from minimal to high risk.
It is also essential to further consider the future outlook and emphasise the importance of addressing liability and ethical considerations, such as transparency and discrimination in ensuring responsible AI deployment. We point out the necessity for a balance between fostering innovation through AI and maintaining stringent regulatory compliance to ensure safety and ethical standards are met in early drug development process.
Finally, we underline the evolving regulatory landscape, including the recently adopted Product Liability Directive and forthcoming AI Liability Directive, for their potential impacts on accountability standards in AI-driven drug development. This fact highlights the need for comprehensive legal strategies to navigate the complexities posed by AI technologies in pharmaceuticals, thereby underscoring the dual importance of innovative progress and regulatory compliance to foster responsible drug development process.