This book explores how artificial intelligence is transforming the pharmaceutical industry and examines the legal challenges arising from its integration into every stage of the drug lifecycle. From target identification, molecular design, and clinical development to regulatory approval, manufacturing, and pharmacovigilance, the volume provides a comprehensive legal framework for understanding what the author terms algoraceutics, the growing convergence of artificial intelligence and pharmaceutical innovation.
Combining insights from information technology law, pharmaceutical regulation, civil liability, intellectual property, competition law, and data governance, the book explains how contemporary AI systems, including machine learning models, generative AI, digital twins, and autonomous research platforms, are reshaping drug discovery and development. It analyzes the opportunities created by these technologies alongside their legal implications, including questions of inventorship, product liability, algorithmic transparency, explainability, patient protection, and access to data.
Particular attention is devoted to the European regulatory framework, including the AI Act, the Product Liability Directive, the Data Act, the European Health Data Space, and the evolving guidance of the European Medicines Agency and the U.S. Food and Drug Administration. The book further examines cutting-edge issues such as AI-assisted pharmaceutical inventions, digital twins and in silico clinical trials, algorithmic decision-making in research, and the role of explainability techniques such as SHAP and LIME in regulatory and judicial proceedings. Written from an international perspective and grounded in both legal doctrine and regulatory practice, this timely work serves as an authoritative guide for academics, legal practitioners, regulators, and professionals working at the intersection of law, artificial intelligence, biotechnology, and the life sciences. It offers a rigorous yet accessible analysis of one of the most significant technological transformations shaping the future of healthcare and pharmaceutical innovation.
