Bioinformatics in the UK, India and China

By Brian Salter, Yinhua Zhou and Saheli Datta

Bioinformatics has recently been recognised in the UK as a ‘huge priority for government’ with the ‘potential to drive research and development, increase productivity and innovation and ultimately transform lives.’ (UK Medical Research Council, 2014). While there is wide agreement among nations regarding the importance of bioinformatics, there is little consensus over possible pathways for maximising its contribution to the life sciences. A recent paper by Salter, Zhou and Datta (2015) explores the extent to which bioinformatics have become a strategic priority for India, China and the UK, and how these efforts are shaping or are in turn being shaped by the existing norms, rules and institutions in the global lifesciences.

Bioinformatics is the combination of knowledge, skills and techniques of biology made 'readable' with computer science, statistics and mathematics. The traditional view of the role of mathematics and computer science in bioinformatics was that of a 'means' to the end of capturing and understanding increasingly data-intensive biological knowledge production e.g. as with genomic data. However, in the last few years a more balanced view has emerged that considers computer science and mathematical tools as both the object and instrument of knowledge production. Leonelli’s (2012: 2) comment that ‘data-intensive methods are changing what counts as good science’- is perhaps nowhere more relevant today than in bioinformatics where the tug-of-war for primacy between two disparate branches of science (mathematics and biology) has become increasingly polarized.

For nations, in particular emerging economies, these spaces of rapidly advancing technology, uncertainty and political tensions that sit uncomfortably within the hegemonic norms, rules and institutions in the global lifesciences increasingly represent spaces of future growth and opportunities for catching up with the west. For emerging economies, the ensuing shift from ‘developmental state’ into what has been described as the ‘adaptive state’ and the ‘transformative state’ signals the opportunity to shape global lifesciences according to their national interests (Kim, 1999; Salter, 2009a; Wu, 2004; Wong, 2005). For the west, the changing nature of ‘science’ and simultaneously the changing role of emerging economies’ participation in global sciences, questions the established mutually beneficial relationship between ‘state and science’ – where science supplies the state with a flow of knowledge, and the state supplies science with the resources to pursue research interests – the fundamental question being how to accommodate transnational science with national interest?

Yet, it would be mistake to presume that the changing nature of science presents only opportunities and few challenges for emerging economies. From a political perspective, the mutually beneficial state-science relationship at the heart of western domination of global lifesciences since WWII never really developed in India, China or Brazil. Simply put, science in the BRICS lacked political value – until now; thus today, for science to progress the key need is to forge and nurture the ‘science and state’ relationship. Furthermore, while a scientific elite is emerging in the BRICS, their experience in negotiating the key science-state relationship to take the national scientific ambition forward is lacking - although the reverse influx of seasoned diaspora (to the BRICS) from elite western scientific communities is helpful. Similarly, the institutional tools generated by more than sixty years of western domination of global lifesciences is reflected in the hegemonic dynamic of today's global bioinformatics governance and in turn disadvantages new entrants like the BRICS whose establishment of similar institutional strengths is still in its nascent stages. For instance, the Bermuda rules of 1996 enabled the development of bioinformatics self-regulation in western nations, but at the exclusion of China and India.

In the case of China, a top-down style of innovation governance has been adopted with the State Council setting the 'science' agenda with its Five Year Plans. Similarly, India’s Planning Commission’s (recently dissolved) has so far used a similar mechanism of Five Year Plans to set the agenda for the Ministry of Science and Technology (MOST) and the Department of Technology (DIT). In contrast the UK's bottom-up approach with funding from both public and private sources is strengthened by a state apparatus that collaborates closely with a science-led (and scientific elite led) agenda. Neverthless, the Chinese or Indian state's committment to becoming global players cannot be doubted. For instance, between 2005 and 2014, China invested a whopping £303 million in bioinformatics compared to India’s £18 million and UK’s £163.9 million. However, a close study reveals that the bulk of China’s funding of £216 million while earmarked under the broad category of ‘bioinformatics’ was further earmarked under the sub-category ‘New Drug Creation and Development (2009-2010)’ – implying that states differ in their interpretation of what constitutes or differentiates bioinformatics from biomedical innovation.

That western hegemonic domination of global lifesciences has extended into bioinformatics is an accepted fact. However, the extent to which this status quo will be retained given the changing nature of science and the spaces of opportunity it has created for the BRICS to climb ever higher in the global lifesciences value chain, is worth questioning.

This blog post originally appeared on the Global Biopolitics Research Centre blog on 15 July 2015.

Consumer choice, governance and the global stem cell therapy market

Image by dream designs, FreeDigitalPhotos.net

By Brian Salter, Yinyua Zhou and Saheli Datta

Existing modes of regulation in stem cell therapy innovation offer little recognition of the role of health consumer choice in the governance of this emerging global market. Instead, there is a strong, and familiar, emphasis on the roles of scientists, clinicians and bioethicists in determining what regulation should be provided, when and by whom. For the most part it is assumed that health consumers (patients) should be protected from themselves through regulation that renders consumer choice redundant because the apparatus of the state or professions has ensured on their behalf that available treatments are safe and efficacious. Their best interests are served, it is maintained, by their continuing faith in their regulatory guardians. This article argues that such an approach to regulation is outmoded and inefficient because it fails to address the governance needs of motivated, mobile consumers in the global stem cell therapy market. Such consumers require a balance between information that facilitates their ability to make rational choices and the confidence that provider regulation is fit for their purpose.

The dominant orthodox approach to governance works so long as the authority of science, medicine and, to a lesser extent, bioethics is able to control the operation of the health care market by convincing consumers that their choices of treatments should be what science, medicine and bioethics say they should be. The logic of this interpretation of the market is that consumer demand for stem cell therapies should adjust to the available supply generated by the orthodox scientific model of stem cell innovation characterised by the sequence of basic research, clinical experimentation, product development, clinical trials, product approval and clinical application, regardless of the timescale involved. In the case of stem cell therapies, this approach to market governance has clearly failed. The rapid and continuing expansion of a global market of innovative treatments measured in terms of hundreds of clinics treating thousands of patients has occurred independently of the very small stem cell therapy market supplied by the outputs of the orthodox model. Alternative, practice based models of stem cell innovation have developed that respond to consumer demand much more readily than the orthodox model. This poses demand side governance challenges which need to be recognised and addressed.

Much of the expansion in the supply of stem cell therapies has taken place in non-Western countries such as China and India where the assumptions of the orthodox model of stem cell innovation are less comprehensively embodied in regulatory arrangements and there is a greater tolerance of clinician led medical innovation. Whereas in Europe medical innovation supplies therapies for single or small groups of patients in what is presented, in the case of the Hospital Exemption at least, as a non-routine exercise, in non-Western countries this model routinely provides therapies for large populations of patients (see e.g. NutechMediworld, Zhongyuan Union Stem Cell, Celltex and Unique Cell Treatment Clinic). In other words, medical innovation and consumer demand responsiveness are regarded as normal rather than exceptional. In an interesting variant, some companies have combined elements of medical innovation and scientific innovation into a single business model. Here, profits from the stem cell medical innovation treatments for one set of diseases are re-invested in the funding of registered clinical trials for stem cell scientific innovation (orthodox model) with regard to a different set of diseases (e.g. Beike Biotechnology, Chaitanya Stem Cell Therapy Centre).

Health consumer demand for stem cell therapies is not easily diverted by the advice of leading authorities. It is not, as is frequently implied, merely a matter of toning down the hype and consumer demand ‘pull’ generated by the competing optimistic visions of the factions of stem cell science and stem cell clinics; there is also the very considerable demand ‘push’ created by the engagement between a consumer’s health status and the domestically available health care supply. The constraints imposed by a particular disease condition, the proximity of pain and/or death, and the limits of local treatment serve to structure a calculation of risks and benefits with its own internalist rationality. Where patient organisations are well organised, this economic demand for treatment may translate into political demand for changes in the orthodox model and its governance: for example, in the cases of AIDS and neuromuscular disorders. Most recently, in Italy protests from patient groups led the Italian Parliament to introduce legislation in May 2013 to allow experimental stem cell therapies on 32 terminally ill patients to proceed.

The general reticence to engage with the reality of the global market of stem cell therapies serves to perpetuate the present neglect of consumer demand led medical innovation and the forms of governance it requires. It is a reticence that has both supporters and opponents and is unlikely to remain politically unchallenged for long and bioethicists are beginning to acknowledge the issues posed by medical innovation in the stem cell field (5). It is important, also, that the present governance vacuum surrounding practice-based medical innovation is addressed by the medical profession itself through changes in its normal systems of self-regulation and professional guidance. Commenting on the ‘sclerotic’ qualities of the established drug innovation model traditionally sponsored by the US and European Union, Joyce Tait observes of China and India that ‘these increasingly powerful components of the bioeconomy may see a competitive advantage in leading regulatory reform so as to encourage more innovative health care sectors to develop, initially for their large and increasingly wealthy home markets, and perhaps also to encourage change in the United States and European regulatory systems’. Given the market benefits that may accrue from the association of these emerging economies with stem cell medical innovation as documented in this paper, it would be irrational of them to do otherwise.

For more details, please refer to:
Brian Salter, Yinhua Zhou, Saheli Datta (2015). Hegemony in the marketplace of biomedical innovation: Consumer demand and stem cell science. Social Science and Medicine. 131: 156-163.
doi:10.1016/j.socscimed.2015.03.015

Making Choices: Health Consumers, Regulation and the Global Stem Cell Therapy Market

Global Medical Discovery highlights a recent article by Brian Salter, Yinhua Zhou and Saheli Datta as a feature article for this month's issue. The excerpt below highlights the article's key findings.

The general reticence to engage with the reality of the global market of stem cell therapies serves to perpetuate the present neglect of consumer demand-led medical innovation and the forms of governance it requires. It is a reticence that has both supporters and opponents and is unlikely to remain politically unchallenged for long, and bioethicists are beginning to acknowledge the issues posed by medical innovation in the stem cell field [14]. It is important, also, that the present governance vacuum surrounding practice-based medical innovation is addressed by the medical profession itself through changes in its normal systems of self-regulation and professional guidance. Commenting on the ‘sclerotic’ qualities of the established drug innovation model traditionally sponsored by the USA and EU, Joyce Tait observes of China and India that ‘these increasingly powerful components of the bioeconomy may see a competitive advantage in leading regulatory reform so as to encourage more innovative health care sectors to develop, initially for their large and increasingly wealthy home markets, and perhaps also to encourage change in the United States and European regulatory systems’ [15]. Given the market benefits that may accrue from the association of these emerging economies with stem cell medical innovation as documented in this paper, it would be irrational of them to do otherwise.

For more details please refer to Global Medical Discovery.

The full article can be found at: Salter, Brian, Yinhua Zhou, and Saheli Datta. (2014). "Making Choices: Health Consumers, Regulation and the Global Stem Cell Therapy Market." BioDrugs: 1-4.