State strategies of governance in global biomedical innovation: the impact of China and India

本研究的目的是研究中国和印度的战略在国家，区域和全球层面的生物医学创新的治理的性质和影响，以及对英国政策的影响。医疗生物技术是英国政府的优先事项，在几个领域都处于世界领先地位。在一次高级别研讨会上，与赞同这项研究的英国决策者就政策优先事项和本研究的设计进行了辩论。医学生物技术的两个优先领域进行了调查，每个重点围绕两个案例研究的实质性生物医学/经济活动：再生医学（干细胞研究;组织工程伤口护理）;和分层/个性化医学（生物信息学;药物基因组学）。这些产品的科学研究和开发领域有望彻底改变全球医疗保健，并应对主要的公共卫生需求。“新兴大国”，特别是中国和印度，在这些领域的影响力越来越大，各国政府、监管机构、科学机构、行业参与者和其他利益相关者正在制定新的战略，以保持和提高其在全球生物医学经济中的地位。与此同时，越来越多地使用“生物”科学和技术，开发复杂的生物社会数据库和人类细胞库（“生物库”）用于治疗开发，提出了一系列伦理、社会和法律的问题，不同的社会以非常不同的方式处理这些问题。该研究汇集了政治学，创新研究以及生物医学和医疗保健社会学学科的概念，为这些新兴发展提供了新的证据基础。在ESRC新兴大国网络项目的平台上，研究重点是在美国，欧盟和东南亚科学和经济影响力的全球背景下，印度，中国和英国之间的关系。本研究针对四个个案进行研究，主要内容包括：1.描述中国和印度创新政策、战略和行动的主要组成部分和方向; 2.分析这些战略如何与英国、欧盟、北美和日本等发达经济体所采用的战略相一致或相背离; 3.评估新兴大国战略在多大程度上参与、挑战或确认现有的跨领域区域和全球治理机构以及私人和公共领域的行动; 4.围绕生物医学经济和卫生政策的这些优先股评估英国政策的影响。该研究采用了研究和政策分析方法相结合的方法，包括定量数据集的二次分析，在英国，印度和中国的主要实地调查数据收集（访谈，会议观察）。收集的数据将包括：专利/知识产权趋势;标准制定活动;投资趋势;“私人”监管举措，如通过专业协会或科学网络;正式监管举措;患者和公众参与治理过程的模式和内容;未来医疗保健的公共政策愿景。在整个研究过程中，英国和新兴大国的政策制定者将通过一系列专家研讨会参与讨论研究。同样，将在联合王国召开公众/患者论坛，让这些利益相关者群体参与进来。研究团队将通过调整国家竞争和合作全球互动的政治科学理论，与社会学/创新研究对新兴医疗经济部门如何出现和稳定的分析，推进全球生物医学创新理论。这一理论工作将有更广泛的应用，超出了医疗生物技术的实质性领域。该研究的实质性结果将为英国制定未来医疗保健的医疗生物技术创新政策提供信息。

The aim of this research is to examine the nature and impact of China and India's strategies on the governance of biomedical innovation at national, regional and global levels and the implications for UK policy. Medical biotechnology is a government priority in the UK, which claims a world-leading position in several sectors. Policy priorities and the design of the present research were debated in a high-level workshop with UK policy makers who endorsed the research. Two priority fields of medical biotechnology are investigated, each focused around two case studies of substantive biomedical/economic activity: Regenerative Medicine (Stem cell research; Tissue-engineered wound care); and Stratified/Personalised Medicine (Bioinformatics; Pharmacogenomics). These areas of scientific research and development of products promise to revolutionise healthcare globally, and respond to major public health needs. The 'Rising Powers', especially China and India, are becoming increasingly influential in these fields, and national governments, regulators, scientific institutions, industry actors and other stakeholders are moving to develop new strategies to maintain and improve their positions in the global biomedical economy. At the same time, the increasing use of 'bio' science and technology and the development of complex biosocial databases and human cell banks ('biobanks') for therapeutic exploitation raise a host of ethical, social and legal issues which different societies approach in very different ways. The research draws together concepts from disciplines of political science, innovation studies, and sociology of biomedicine and healthcare, to provide a new evidence base of these emerging developments. Building on the platform of an ESRC Rising Powers Network project, the research focuses on relations between India, China and the UK, in the global context of US, EU and South East Asian scientific and economic influence. Focusing on the four case studies, the research will: 1. Describe the primary components and directions of China and India's innovation policies, strategies and actions; 2. Analyse how these strategies align with or depart from those employed by the developed economies of the UK, EU, North America, and Japan; 3. Assess the extent to which the Rising Powers strategies engage with, challenge or confirm existing cross-cutting regional and global governance institutions and actions in both private and public spheres; 4. Evaluate the implications for UK policy around these priority strands of biomedical economy and health policy. The research uses a combination of research and policy analysis methods, comprising secondary analysis of quantitative datasets, primary fieldwork data collection (interviews, observation of conferences) in the UK, India and China. Data collected will include: patent/intellectual property trends; standard-setting activity; investment trends; 'private' regulatory initiatives such as via professional associations or scientific networks; formal regulatory initiatives; modes and content of patient and public engagement with governance processes; public policy visions of future healthcare. Throughout the research, policymakers in the UK and Rising Powers countries will be involved in debating the research through a series of expert workshops. Similarly, public/patients forums will be convened in the UK to provide involvement of these stakeholder groups. The research team will advance the theory of global biomedical innovation by aligning political science theory of states' competitive and cooperative global interaction with sociological/innovation studies' analysis of how emerging medico-economic sectors emerge and stabilise. This theoretical work will be of broader application, beyond the substantive field of medical biotechnology. The substantive findings of the research will inform UK policy for medical biotech innovation for developing the healthcare of the future.