Biomedicine and Beyond: The Social and Regulatory Dimensions of Therapeutics in Japan and the UK

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Japan and the UK are at the leading edge of therapeutic research in biomedicine, in terms of both basic science and innovation. From genome editing to antimicrobial resistance, therapeutic research and implementation is ever-more diverse in both countries, impacting public and personal life - with therapeutic innovation itself affected as a consequence. Japan and the UK are also both facing the challenge of increased healthcare costs, not least of which relate to ageing populations, and therapeutic innovation is expected to somehow reduce these costs. More generally, both countries regard biomedical innovation as an important driver of national economies, and 'pro-innovation' regulatory frameworks are increasingly demanded. Regulations impact how therapeutics are developed and which are ultimately available for patients to access. Despite these various similarities, Japan and the UK are differently positioned with respect to local social contexts and norms, histories of medicine, national and supranational regulatory environments, and the global dynamics of biomedicine. Our proposed research will extend the interdisciplinary approach we have developed through earlier scholarship, in order to examine the intersection of therapeutics, regulation, and society. Through comparative research, we will explore how different social and regulatory contexts interact in the shaping of biomedicine and health. We will develop new insights into how both international law and transnational movements of scientists, clinicians, and ideas inform national-level therapeutic innovation. The project will also address conceptual questions relating to the nature of law and regulation, and of biomedicine. Our work will focus on drawing out both how the social and regulatory dimensions of therapeutics jointly shape development and implementation, and how the growing importance of therapeutics to public life are reworking the nature of social and regulatory processes themselves. We will explore these issues from different social science and humanities disciplinary perspectives, while emphasising science and technology studies (STS), socio-legal studies, and bioethics. Our workplan has been designed to develop new relationships between: (i) the investigators, (ii) individual investigators and the wider networks of the collective of investigators, and (iii) early-career researchers, the investigators, and their networks. These relationships will be scaffolded by and enhanced through the core activities of the project, which are: (a) three workshops and (b) an early-career researcher mobility bursary scheme. It is envisioned that there will be 7 'ESRC-AHRC Therapeutics, Regulation, and Society Mobility Bursaries' of up to £3, 000 each, for four UK and three Japan-based ECRs to travel to the other nation for training and network building around the project theme for approximately two weeks. Each ECR will be mentored by one or more of the investigators.We will produce a range of outputs from our research, including a journal special issue, and peer-reviewed papers aimed at different humanities and social sciences audiences. We will also seek to engage policymakers and regulatory organisations with our work, as well as biomedical scientists and healthcare professionals (e.g. through invitations to our workshops, commentaries for biomedical journals, and one-to-one meetings), as wider publics. All the investigators are committed to engagement with wider publics, and we will achieve this through, for instance, articles in popular media in Japan and the UK, and public panel discussions and similar events associated with our workshops.Our project comes with considerable in-kind and direct support from the Japan-based co-investigators, evidencing their strong commitment to developing this work. Indeed, their support is over twice as much as the sums requested from the ESRC and AHRC, and hence more than triples the over-all value of the award.