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

Lead Research Organisation: King's College London
Department Name: Political Economy


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Description Key Finding 1 - Political economy: hegemony, markets and the 'dualistic' state
The aim of the research was 'to produce conceptually advanced evidence on 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'. In addressing this aim, one of the important theoretical advances has been the novel application of Gramsci's theory of hegemony to the case of globalised biomedical innovation, integrating this approach with an analysis of the global health consumer market as the vehicle for the emergence of a counter-hegemonic challenge. China, India and the UK were then positioned in terms of their contribution to the political struggle between the hegemonic and counter-hegemonic forces.

Taking stem cell science as the empirical case, this aspect of the research concluded that health consumers are able to challenge the hegemony of the science-based paradigm of stem cell innovation though the exercise of their demand in a global market of practice-based medical innovation. Despite the global reach of biomedical science (the blocco storico), its ideological cadre of bioethicists acting as its traditional intellectuals, its total dominance of the research funding market, its extensive political network of transnational scientific institutions and its established alliance with agencies of the state in the UK and to a lesser extent in China and India, the hegemony has proved fallible in the case of stem cell innovation. A counter-hegemony of consumer values and action has begun to emerge in an economic territory over which the hegemony has little control, where consumers are geographically mobile, and where the demand-supply relationship is engineered through an elusive system of internet-driven information. Health consumers are able to choose and purchase new health treatments generated by practice-based medical innovation in ways regarded as illicit by the orthodox paradigm of innovation. As the counter-hegemony gains strength, so the collision in biomedical innovation between the logic of consumer choice and the logic of orthodox science becomes ever more apparent. Even within its own territory the hegemony has suffered reverses as some states such as the UK, impatient with the implacable adherence of science to its discovery-based values without apparent regard for the patient-based values of medicine, have begun to engage in trasformismo and make governance changes to enable greater responsiveness to health consumer need and so draw their citizens back within the hegemonic boundaries.

China and India have other options. Lacking fully-developed systems of governance predicated on the values of the science-based hegemony of innovation, they have adopted a 'dualistic' position where they publicly adopt a position in support of the hegemonic model but privately allow practice-based medical innovation to occur in unregulated political spaces. This approach allows them to retain the benefits of membership of the transnational biomedical community whilst at the same time accessing the wealth of the growing market of stem cell treatments generated by the mobile health consumer. Thus, judicious but limited biomedical innovation governance becomes a means for simultaneously exercising control and creating market opportunities.

Key Finding 2 - STS: Lessons from the case studies
Regenerative medicine
There are received, stereotyped notions about the laxity of certain national regulatory regimes which may be better understood in terms of different levels and locations of legitimation. In the case of controversial stem cell therapy, for example local bespoke ethical review committees and sub-national regional state authorities are providing legitimation and resourcing support that in principle 'contradicts' national positions, especially outward-facing adaptation to dominant western scientific models. During the lifetime of the project we observed regulatory policy developments that can be read as showing some convergence at national policy level: the rise of 'exceptions and exemptions' and early access schemes in the UK/EU and in India the recent central policy restriction of stem cell therapy to 'research-only' status.
Stem cells/regenerative medicine has become framed as a distinct sector and industry in the UK much more explicitly and coherently compared to India and China. This is reflected in government stated 'life science' policies and funding organisations and regimes. In both India and China the comparable support structures and incentivisation routes are much more diverse and regionally dispersed.
The few social science accounts of bioinformatics to date have focused mainly on'internalist' analysis, for example of disciplinary conflicts between biology and informatics/IT. Acknowledging a strong forward-looking steer from our UK national regulatory and health policy advisors, we have opened up a socio-political analysis of the governance of bioinformatics innovation in recognition of its increasingly central place in global life science. We found that the history of the emergence of bioinformatics varied enormously between the three nation-states, India for example having an initial focus on IT infrastructure, and China building on a move of physicists and engineers into biology, and then more piecemeal support of individual research centres.
Because bioinformatics is a platform technology (at least in the sense of it being susceptible to a wide variety of applications), its policy framing by different polities and bioeconomic ambitions is indicative of particular states' approaches to innovation governance in the life sciences. Thus, we find that China's research funding profile has been broadly aimed toward stimulating a bio-industry including a service sector (BGI the Beijing Genomics Institute being the recurrent reference point globally) with little focus on particular disease applications. India on the other hand, shows a commitment to some elite genomics driven academic centres alongside some commercial service stimulation (mirroring the well-known phenomenon of outsourced clinical trials), more explicitly gearing toward nationally important infectious diseases, and a current attempt to resource a national facility through a public-private partnership model. The UK's position is conspicuously driven by the presence of the European Bioinformatics Institute and its very strong partner and funding networks, and together with the advent of 'Genomics England' we see here a very strong commitment to developing bioinformatics within a nationally coordinated (and internationally, especially US, linked) public-private genomics-for-research-and-health bioeconomic project.

Advanced wound care (AWC)
We have produced unique analysis of this field which, whilst important in the UK's life science policy, has been greatly neglected in social science analysis, though the field's struggles with 'evidence-based medicine' has been documented. AWC is an acknowledged policy object in the UK but not in India or China. The UK has developed a coordinating governance infrastructure that ties R&D (for example in cell therapy and bio-sensing) into the NHS and commercial enterprise through a brokering function (Healthcare Technology Cooperatives), which is not paralleled in India or China. In both India and China R&D in this field takes place especially in burns centres, including in the military sector. India has just supported a single such centre to stand as a national centre, industrial and domestic burns being a major government health concern.
Conceptual advance
The above work advances theorisation at the interface of political science and sociology of biomedicine and regulation, by deploying in parallel notions of consumer and stakeholder challenge to hegemonic biomedical science, with notions of the sectorisation and stabilisation of emerging life science innovation, in global, transnational and national contexts.

Key Finding 3 - New research networks: a platform for the next project
A key part of the project methodology was interviews with scientists, policymakers and industrialists in the UK, China and India working in the fields of regenerative medicine and personalised medicine. Whilst the team's previous research experience provided numerous access points in the UK, these were more limited in the case of China and India. Here we report on the new networks established in the latter two countries which we plan to use as a platform for further research on the global politics of health consumers (documented under Key Finding 4). The networks span the domains of science, government and industry, often linked by 'gatekeepers' with access to more than one domain. The total membership of these networks is approximately 100, often characterised by individuals working across the science, policy and industry arenas . Below are examples of how the networks were created through the 'snowballing' technique of interviewee recommendation, their institutional locations and key members.

In personalised medicine academic colleagues at the Institute of Science, Technology at Tsinghua University helped the project gain access to leading bioinformaticians such as Professor Jingchu Luo. This led to institutional links being formed with organisations such the Centre for Bioinformatics at Peking University and the Beijing Genomics Institute. In regenerative medicine, leading stem cell scientists and clinical researchers were approached through the good offices of Professor Zhenzhen Li, Director of the Centre for Science and Technology Ethics, Institute of Policy and Management in the Chinese Academy of Sciences (CAS). Access to senior government officials in China is often challenging. Here we were fortunate in the help provided by Dr Wang Ge (Chinese Academy of Science and Technology for Development (CASTED) within the Ministry of Science and Technology (MOST)) to conduct interviews with officials in MOST and the China Food and Drugs Administration (CFDA). Further introductions to policy makers were provided by Professor Xiaomei Zhai, Dean of the School of Humanities and Social Sciences, Peking Union Medical College and member of China's National Health and Planning Commission.

Our Indian networks centre on science and technology policy makers in New Delhi, and scientists and industrialists in the Bangalore and Hyderabad biotech clusters and the global innovation hubs of the Indian Institute of Technology (IIT). Professor Vijay Raghavan, Secretary of the Department of Biotechnology (DBT), linked the project, firstly, to the Delhi policy maker networks (for example, Dr Alka Sharma, Stem Cell Task Force of India), secondly, to senior scientists relevant to our research (for example, Professor Balasubramanian, head of the LV Prasad Eye Institute in Hyderabad) and, thirdly, to the Bangalore biotech cluster. Professor Balasubramanian then facilitated access to India's Hyderabad biotech cluster including the 'Genome Valley'. Within the IIT organisation, Professor Sanjeev Srivastasa at IIT Mumbai and Professor Naveen Thayyil at IIT Delhi enabled interviews with leading scientists and industrialists in our case study domains. In the stem cell science case study, Professor Sumata Mohanty, head of India's translational Stem Cell Research Facility at the All India Institute of Medical Sciences (AIIMS) introduced the project to a number of senior scientists in the field.

Key Finding 4 - Taking the theory forward: Performativity and (counter) hegemonic biomedical markets

The project has produced a developmental theoretical framework that works to better integrate our existing Gramscian analysis of healthcare markets (Salter et al 2015) with existing Science and Technology Studies (STS) literature. In doing so we opened up important new research questions to be explored in a pattern of subsequent empirical work to inform ongoing theoretical development. This programme of work began by extending our repertoire of Gramscian ideas to include civil society, base and superstructure relationships, and consent and coercion relationships. We then theorised the connectivities to two key ideas under current consideration in the STS literature: market performativities and publics.

The market performativities literature extends arguments found in the sociology of expectations (Brown and Michael 2003) to economic contexts. Important work by Callon (1998), MacKenzie (2005), and Pollock and Williams (2010) explore the ways in which economic and market rationalities are mobilised not only to understand market relations but also to shape them. Existing work on this 'performative turn' centres on financial and procurement markets. We expand this in two important ways. Firstly we consider biomedical markets, with their distinctive sets of actors (large and small companies, public and private healthcare providers, patient representative groups). Secondly we situate this work in dialogue with our Gramscian analysis of hegemonic markets - based upon an ethic of scientific evidence - and counter-hegemonic markets - based upon an ethic of care - in biomedicine. This is productive in at least two important ways: (1) It allows an STS influenced inspection of Gramsci's understanding of the relationship between base and superstructure, with notions of the performativity of economic actions bringing novel insight to the relationship between economic base and the social structures that surround it. (2) It allows us to develop the novel theoretical model of hegemonic performativities and counter-hegemonic performativities, to explore theoretically and empirically the differing typologies of performative action that provoke economic relations and bring market forms into being. Importantly, our argument is that the typologies of performativity in the existing literature consider only hegemonic performativities and our work seeks to address this imbalance.

Our second site of intersection between STS and our account of Gramsci inspects the relationships between Gramsci's notion of civil society and subalterns and recent STS scholarship on publics. A framework of hegemonic and counter-hegemonic publics incorporates STS notions of counter publics (Haran 2013) and unruly publics (de Saillea 2015) invoked in imaginaries of publics fostered by states (Hess 2015, Welsh and Wynne 2013) and institutions (Stephens, Atkinson and Glasner 2013) into a Gramscian account of hegemony secured through consent and coercion. Recognising the national and international component here we situate in dialogue Jasanoff and Kim's (2009) notion of socio-technical imaginaries of nationhood and science policy with Gramsci's account of the national-popular. By integrating Gramsci with STS arguments on market performativities and publics we provide a framework to further inspect how rising and established powers construct and contest global healthcare markets.

Brown, N., and Michael, M. (2003) A sociology of expectations: retrospecting prospects and prospecting retrospects Technology Analysis and Strategic Management, 15 (1): 3-18.

Callon, M. (ed) (1998) The Laws of the Markets. Oxford: Blackwell.

De Saille, S. (2015) Dis-inviting the Unruly Public Science as Culture 24(1) p99-107.

Haran, J. (2013) The UK Hybrid Embryo Controversy: Delegitimising Counterpublics Science as Culture 22(4) p567-88.

Hess, D. (2015) Public as Threats? Integrating Science and Technology Studies (STS) and Social Movement Studies (SMS) Science as Culture 24(1) p69-82.

Jasanoff, S. and Kim, S. (2009) Containing the Atom: Sociotechnical Imaginaries and Nuclear Power in the United States and South Korea Minerva 47(2) p119-46.

MacKenzie, D. (2006) An Engine not a Camera: how financial models shape markets, Cambridge (Massachusetts): The MIT Press.

Pollock, N. and Williams, R. (2010) The business of expectations: How promissory organizations shape technology and innovation Social Studies of Science 40 (4): 525-548.

Salter, B. Zhou, Y. and Datta, S. (2015) Hegemony in the marketplace of biomedical innovation: Consumer demand and stem cell science Social Science & Medicine 131 p156-63.

Stephens, N., Atkinson, P., and Glasner, P. (2013) Institutional imaginaries of publics in stem cell banking: the cases of the UK and Spain Science as Culture, 22 (4): 497-515.

Welsh, I. and Wynne, B. (2013) Science, Scientism and Imaginaries of Publics in the UK: Passive Objects, Incipient Threats Science as Culture 22(4) p540-66.
Exploitation Route The project's Pathways to Impact plan involved the engagement of policymakers and academics in a series of five workshops in China, India and the UK (see which created important expert networks in the three countries (see Key Finding 3). Ideas and material will continue to be fed into these networks in the course of design of the next project on 'The global politics of health consumers' as part of a consultative exercise (Key Finding 4). In addition, the project will be participating in the Rising Powers impact programme through a contribution to its 'innovation' theme on transnational regulation.
At the same time the findings of the project on the biomedical innovation process with regard to the different contributions in the three countries of health consumers, the scientific community, and regulation suggests that an inter-country dialogue on these issues would be mutually beneficial (Key Findings 1 and 2). The project has an established network in consumer, science and regulatory organisations that could be used as the initial platform to bring together relevant actors.
Sectors Healthcare

Description Since the end of its ESRC funding in September 2015, the project has continued to enhance its impact through the engagement of team members with policymakers, new projects, publications in scientific journals and policy workshops. The platform and networks for these activities was established in the course of the project through its seven workshops in the UK, China and India with participants drawn from government, industry and NGOs ( The object was, and is, to influence policy and professional practice by providing evidence derived from the project findings on more efficient and effective means for governing biomedical innovation. Team members have contributed directly to the policy making process. Faulkner submitted written evidence to the House of Commons Select Committee on Science and Technology's inquiry into EU regulation and the life sciences (June 2016) and made a presentation to the All-Party Parliamentary Health Group as part of its discussion of 'Regenerative medicine: the ground-breaking opportunities it offers for improving patient healthcare' (November 2016). Both were informed by his membership of the National Institute for Clinical Excellence (NICE) Medical Technologies Advisory Committee. His contributions have helped to increase awareness among policymakers and regulatory officials of how linkage can be created through their regulatory initiatives between the funding, business models and delivery mechanisms of new modes of regenerative medicine in order to provide patients with improved treatments at the earliest opportunity. In the field of the governance of personalised or precision medicine, Hogarth's contribution to the Department of Health's Emerging Science and Bioethics Advisory Committee and an external strategy group advising the Medicines and Healthcare Products Regulatory Agency (MHRA) on EU regulations for diagnostic devices has drawn on project findings to illuminate the need for regulatory connection between the diagnosis and the treatment of particular diseases: governance domains that are normally separate and distinct. By showing policymakers how and why the domains need to be integrated, Hogarth has helped prepare the ground for the policy changes required to deal with the advent of genomic medicine. The policy influence dimension of this work will be continued through the prestigious ERC Starting Grant Hogarth has recently been awarded to conduct a comparative analysis of the political economy of diagnostic innovation, focusing on the development and diffusion of new technologies for screening and early detection of cancer in the UK, USA and France. Meanwhile in China, Zhou has recently presented a paper on the regulation of precision medicine at a workshop for policymakers from the Ministry of Health and the National Centre for Science and Technology Evaluation organised by the Chinese Academy of Medical Sciences (December 2016). Given that China has a strategic commitment to the development of precision medicine but lacks the governance expertise to facilitate it, it is intended that Zhou's explication of UK, EU and US approaches to the regulatory issues involved will provide Chinese policymakers with concrete models of innovation governance on which they can draw. In the course of the project, Chinese policymakers have consistently shown themselves to be eager to learn from the Western experience. The intention is that this stream of policy impact work will continue through a project on the path of innovation in precision medicine Zhou has submitted to the China National Science Foundation. In terms of raising awareness in the scientific community of the intricacies of biomedical innovation and the scientific role within it, in India Datta gained a Newton-Bhabha Fellowship in 2015 based at the Indian Institute of Science, Bangalore, supervised by Professor Gagkar -President of the Indian National Science Academy. Here her focus was on engaging with stem cell scientists about the important role to be played by health consumers in the innovation process. In the UK, the influence of the project as a result of scientists' involvement in its seven policy workshops is evidenced by the invitation from the journal Regenerative Medicine to publish two articles exploring the problems in the field of translation from bench to bedside (Salter is a member of its editorial board). In the field of bioinformatics and its presence in the emerging economies, Salter's continuing dialogue with the UK's European Bioinformatics Institute (EBI) drawing on project findings has included discussion with its senior officers of how countries such as China can be supported in their development and governance of the bioinformatics field. This discussion recently coincided with a visit to China by members the EBI senior management team to further explore these issues.
First Year Of Impact 2015
Sector Communities and Social Services/Policy,Healthcare,Pharmaceuticals and Medical Biotechnology
Impact Types Policy & public services