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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.