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

在基础科学和创新方面，日本和英国在生物医学治疗研究方面处于领先地位。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，影响着公众和个人生活——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成本上升的挑战，尤其是与人口老龄化有关的医疗成本，而治疗创新有望以某种方式降低这些成本。更普遍地说，两国都将生物医学创新视为国民经济的重要驱动力，并且越来越需要“支持创新”的监管框架。法规影响治疗方法的开发方式以及患者最终可获得的治疗方法。尽管有这些不同的相似之处，但日本和英国在当地社会背景和规范、医学史、国家和超国家监管环境以及生物医学的全球动态方面处于不同的位置。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，以检查治疗，调节和社会的交叉点。通过比较研究，我们将探索不同的社会和监管背景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流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法规以及生物医学的性质有关的概念性问题。我们的工作将集中在绘制治疗学的社会和监管维度如何共同影响发展和实施，以及治疗学对公共生活的日益重要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之间的新关系：(i)调查人员，（ii）个人调查人员和更广泛的调查人员集体网络，以及（iii）早期职业研究人员，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巩固和加强，这些活动是：(a)三个讲习班和(b)早期职业研究人员流动奖学金计划。预计将有7个“ESRC-AHRC治疗、监管和社会流动性奖学金”，每个奖学金高达3000英镑，为4名英国和3名日本的ecr提供大约两周的时间，让他们围绕项目主题前往另一个国家进行培训和建立网络。每个ECR将由一名或多名调查人员指导。我们将从我们的研究中产生一系列的成果，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组织参与我们的工作，以及生物医学科学家和医疗保健专业人员（例如，通过邀请参加我们的研讨会、为生物医学期刊发表评论和一对一会议），作为更广泛的公众。所有的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，以及与我们的研讨会相关的公众小组讨论和类似活动来实现这一目标。我们的项目得到了日本合作研究人员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ESRC和AHRC要求的两倍多，因此是奖金总额的三倍多。

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.