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

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.

The future of medicine and the health and well-being of society is being shaped by today's governance of biomedical R & D. The objective of this project is to understand the challenges for national and trans-national governance posed by important bioscience developments, and to provide a core research-based foundation of evidence for the range of policy end-users. We will integrate our academic infrastructure with the most concerned policy actors in the UK and internationally, taking forward a new conceptual framework with a suite of critical case studies. The project will examine the capacity of current UK institutional structures to respond to the governance demands of biomedical innovation.

To maximise policy impact, UK end-users have been involved in our project development discussions, including the DH, Office for Life Sciences, the Division of S&T Policy, Directorate for Science, Technology and Industry within the OECD, clinical and commercial participants, and public ethics stakeholders. The non-academic impact is geared primarily to public and private organisations responsible for biomedical investment, policy oversight and regulation, and concerned publics and patient groups. The project's policy aims will be channelled through the two biomedical fields that the Project is organised around, activating a wide range of existing links to policy networks that we will further build upon:

1. Stratified biomedicine: Issues include: economic, clinical and public value of new genetic tests; pharmacogenomics regulation; regulatory adaptation to global developments; ethics of bioinformatics international data set integration. . The House of Lords S&T Select Committee recently reviewed genetic tests, calling for a new White Paper. We will seek to provide evidence to the S&T Committee and Commons Health Committee and the Parliamentary Office for Science and Technology to help shape public policy. We have links to the MHRA's personalised medicine initiative and will provide policy advice to inform the Agency's ongoing work, and to the Royal Pharmaceutical Society which is interested in the opportunities and risks of stratified medicine, and in the wider public/patient domain, the Consumers' Association and specific patient organisations. We will provide evidence to education/skills policymakers and pharma industry, in the area of public and private bioinformatics capacity and related Rising Powers policy.

2. Regenerative biomedicine: Issues include: scale-up, business models and IP; safety standards issues in testing and clinical trials; product regulation; Health Technology Assessment and reimbursement policy. We have existing strong links to the UK Stem Cell Bank and UK Stem Cell Network, the Regenerative Medicine Industry Group of the BioIndustry Association, the Office of Life Sciences review of regenerative medicine, and the Research Councils/TSB Forward Look on regenerative medicine. On research policy, we will link to the European Commission's Research DG's Directorate F (Health), Unit F2 Medical and Public Health Research and the European Society of Cardiology; and, for product regulation, the MHRA including its Medical Technology Forum. We will use participation in NICE to mobilise interest in technology adoption policy.

More broadly, we will engage (through web-based and face-to-face methods) with, and provide evidence to, UK and overseas patient organisations and concerned public constituencies about selected biomedical innovation developments, as they play increasing parts in innovation/governance structures and activities.