[Innovative drug development: ethical and regulatory challenges]

Drug development is undergoing profound change. Accelerated regulatory processes, gene and cell therapies, the use of artificial intelligence, and the increasing use of real-world evidence are fundamentally transforming the pharmaceutical innovation system. These developments offer patients faster access to effective therapies, but at the same time raise significant ethical and regulatory questions: How can the protection of trial participants be reconciled with the desire for rapid innovation transfer? How can an evidence-based risk-benefit assessment be successful when pivotal trials are small and short? What mechanisms ensure the equitable distribution of high-cost therapies in a solidarity-based healthcare system such as Switzerland's? This overview outlines the key trends and provides guidance for practising doctors on the use of innovative medicines.