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

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.

As we outline in the Pathway to Impact attachment, we expect our project to be of interest to a range of academic and non-academic individuals and communities beyond the humanities and social sciences disciplines described in the Academic Beneficiaries section. More specifically, we will seek to create impact within communities of (1) policy and regulatory communities, (2) biomedical scientists and healthcare professionals, and (3) wider publics.

(1) Policy and regulatory communities.
These include individuals associated with scientific bodies that have a formal or informal lobbying and or regulatory role. In the UK, this includes the Royal Society, the Nuffield Council on Bioethics, with which the applicants have previously worked, as well as the Science and Technology Select Committee. This is Chaired by Norman Lamb MP, with whom Pickersgill has developed a relationship through previous work, including a British Academy Rising Star Engagement Award. Given the issues around therapeutic innovation and regulation that we will be exploring through this project, we can anticipate policy interest that we will actively seek to develop (e.g. through targeted emails and requests for one-on-one meetings where appropriate).

(2) Biomedical scientists and healthcare professionals
Biomedical and healthcare professionals are likely to find our work interesting and relevant to the challenges they face in developing and delivering therapeutics. We will generate impact through including biomedical researchers and clinicians in our workshops, and through communicating with them via reflective commentaries in journals such as The Lancet. A recent Lancet article co-authored by Pickersgill and Chan (with others) had an Altmetrics score of 444, and was tweeted 776 times in North and South America, Africa, Europe, Asia, and Australia. Hence, we believe there is considerable appetite for the kind of work we are proposing among biomedical colleagues.

(3) Wider publics
A range of publics are likely to have diverse interests in our work. The issues we will cover in our proposed project extend our existing trajectories (which have previously secured public interest and impact), and given widespread UK and Japanese public interest in, for instance, access to therapeutics we envision that public-facing outputs from our project will generate wider discussion and intrigue.

Our academic and wider dissemination strategy is as follows:

1) Special issue of (e.g.) Medical Law Review or EASTS: East Asian Science, Technology & Society on 'The Social and Legal Dimensions of Biomedicine: Between and Across Japan and the UK' (to be led by four or more of the Investigators) [n.b.: the editor of EASTS, Prof. Wen-Hua Kuo, has been approached for this]
2) A peer-reviewed publication in a journal such as Medical Law International or BioSocieties, outlining the intellectual agenda of the project and populated with relevant empirical examples (to be co-authored by two or more of the Investigators).
3) A peer-reviewed publication in a journal such as Journal of Medical Ethics or Journal of the Japan Association for Bioethics, working through a case-study considered in one or more of the workshops (co-authored by two or more of the Investigators).
4) A peer-reviewed publication in a journal such as the Japanese Journal of Cultural Anthropology, working through a case-study considered in one or more of the workshops (co-authored by two or more of the Investigators).
5) Up to 7 peer-reviewed reflective articles produced by the bursary recipients.
6) A non-peer-reviewed commentary for a journal such as The Lancet, reflecting on the project themes (co-authored by at least four of the Investigators).
7) Up to 4 public-facing media pieces for Anglophonic publications such as Aeon, The Chronicle of Higher Education, and The Guardian.
8) Up to 3 public-facing media pieces for Japanese publications such as Gendai-Shiso.