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

日本和英国在基础科学和创新方面都处于生物医学治疗研究的前沿。从基因组编辑到抗菌素耐药性，两国的治疗研究和实施越来越多样化，影响着公共和个人生活-治疗创新本身也因此受到影响。日本和英国也都面临着医疗保健成本增加的挑战，尤其是与人口老龄化有关的挑战，而治疗创新有望以某种方式降低这些成本。更广泛地说，两国都将生物医学创新视为国民经济的重要驱动力，越来越需要“支持创新”的监管框架。法规影响治疗药物的开发方式以及最终可供患者使用的药物。尽管有这些相似之处，但日本和英国在当地社会背景和规范、医学历史、国家和超国家监管环境以及生物医学的全球动态方面的定位不同。我们提出的研究将扩展我们通过早期奖学金开发的跨学科方法，以研究治疗学，监管和社会的交叉点。通过比较研究，我们将探索不同的社会和监管环境如何在生物医学和健康的塑造中相互作用。我们将对国际法和科学家、临床医生和思想的跨国运动如何为国家级治疗创新提供新的见解。该项目还将处理与法律和规章以及生物医学的性质有关的概念问题。我们的工作将集中在绘制出治疗学的社会和监管层面如何共同塑造发展和实施，以及治疗学对公共生活日益增长的重要性如何重塑社会和监管过程本身的性质。我们将从不同的社会科学和人文学科的角度探讨这些问题，同时强调科学和技术研究（STS），社会法律研究和生物伦理学。我们的工作计划旨在发展以下各方之间的新关系：㈠调查人员; ㈡调查人员个人和调查人员集体的更广泛网络; ㈢职业生涯初期的研究人员、调查人员及其网络。这些关系将通过该项目的核心活动得到加强，这些活动是：（a）三个讲习班和（B）一个早期职业研究人员流动奖学金计划。据设想，将有7个“ESRC-AHRC治疗，监管和社会流动奖学金”，每个高达3000英镑，四个英国和三个日本的ECR前往其他国家进行培训和网络建设，围绕项目主题约两周。每个ECR将由一名或多名研究人员指导。我们将从我们的研究中产生一系列成果，包括期刊特刊，以及针对不同人文和社会科学受众的同行评审论文。我们还将寻求让政策制定者和监管机构参与我们的工作，以及生物医学科学家和医疗保健专业人员（例如，通过邀请我们的研讨会，生物医学期刊评论和一对一会议），作为更广泛的公众。所有研究者都致力于与更广泛的公众接触，我们将通过在日本和英国的大众媒体上发表文章，公开小组讨论和与我们的研讨会相关的类似活动来实现这一目标。我们的项目得到了来自日本的共同研究者的大量实物和直接支持，证明了他们对开展这项工作的坚定承诺。事实上，他们的支持是要求经济、社会和文化权利委员会和澳大利亚人权委员会提供的金额的两倍多，因此是该裁决总价值的三倍多。

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.