Personalised medicine means doctors could soon be prescribing drugs tailored to individuals’ genes. Simmons’ Jacques-Antoine Robert discusses the challenges facing watchdogs and lawyers addressing this brave new world
The regulation of all medicinal products is based on risk management. It is an accepted principle that no medicinal product is entirely without risk – the use and regulation of medicines is therefore calibrated on the concept of benefit versus risk; that is, the degree to which the benefit that the product brings to the patient outweighs the risk to the health of the patient.
