Precision Medicine: Drowning in Regulatory Soup?

Precision medicine is promoted as having the capacity to deliver more personalized healthcare, tailored to an individual’s genetic characteristics, health status and family history. Various sectors of the healthcare industry are involved in precision medicine, including the clinic, the research lab and the diagnostic and pharmaceutical industries. One consequence is that the defined regulatory spaces within which each of these sectors operate are becoming diffuse, resulting in a risk of regulatory overlap, omission and confusion: a ‘regulatory soup’ that could drown the promised advances in precision medicine. In this essay, we explore the challenges involved in modernizing the current regulatory landscape for precision medicine. We outline some of the major technological advances in the field, including genome sequencing, pharmacogenomics, genomic analysis, gene editing and biobanking. We then consider the regulatory ‘soup’ within which these technologies are positioned. We finally explore a range of issues that need to be addressed to ensure that regulation is effective in the future. We conclude that an effective regulatory framework for precision medicine does not necessarily require new laws. It does, however, require careful consideration of how existing laws and other regulatory instruments are applied and interpreted to ensure that new innovations are facilitated, harms are minimized and measured decisions are made about the allocation of limited healthcare funds.