In September 2016, IRGC organised an expert workshop on the governance of precision medicine. The participants, from science, policy, regulation and industry, reviewed the main expected benefits and governance issues involved in the development of personalized medicine, which is based on advances in biomedical data science (including genomics), bio statistics and bio informatics. In particular, the participants discussed which main obstacles will have to be overcome, so that methods for assessing safety and efficacy are adapted to small samples in clinical trials, regulatory licensing systems adapt, the medical practice can change, patients and citizens engage, industry is incentivised, and payment / reimbursement can follow.
Given the potentially far-reaching consequences of precision medicine, understanding the governance challenges associated with the translation of science and technology into the clinical and therapeutical practice, as well as how health and disease are considered by individuals is paramount for decision-makers in the public and private sectors. A risk governance approach of the new emerging field (with interconnected benefits and risks) helps structure the thinking about the implications of precision medicine in the society.
The paper will elaborate from the 2016 workshop and further work on the development of a roadmap for precision medicine, and present how using the IRGC Guidelines for Emerging Risk Governance, can lay the groundwork for decision-makers to start considering risk governance approaches to personalised health and medicine.