Personalised Medicine with Companion Diagnostics: The Intercept of Medicines and Medical Devices in the Regulatory Landscape

Abstract

Personalised medicine, with the aid of companion diagnostics, is a burgeoning field. The potential benefits of personalised medicine with regard to improved patient outcomes and reducing healthcare burden are recognised, but there remains obstacles that may limit growth in this area. Limitations include the current regulatory framework in many areas, in which the pharmaceutical is identified as a medicine, whilst the companion diagnostics are identified as a medical device; thus the two components may be governed and assessed by differing bodies and processes. This in turn results in disparity in approval times, patent and intellectual property claims, and reimbursement. Regulatory agencies are working together with industry and academia towards bridging these gaps, with significant inroads seen across the globe.