The global market of stem cell research and therapies, ‘stem cell tourism’, and models of innovation – Western and non-Western models

The ‘hype and hope’ of stem cell research and treatments has contributed to the expansion of a flourishing ‘illicit’ global market for stem cell therapies. Patients from all over the world are travelling to places like China, Russia, Japan and India to be treated with - mostly experimental - stem cell therapies. This phenomenon has been coined ‘stem cell tourism’.  

Western models

In the West, a combination of a gap between ‘what was promised’ and ‘what is being delivered’, and the slow pace of traditional Western models of scientific innovations has further stimulated a global supply of ‘illicit’ therapies. The conventional science-based model of innovation (Figure 1) is the considered the most ‘sound’ and ‘safe’ approach, but is also the slowest.  

Indeed, “given the high demand for stem cell therapies, the clear market disadvantage of this model is the time and cost of product development. As with general drug development, including preclinical and clinical safety and efficacy testing, therapies can typically take 12–15 years and approximately EU€1 billion to develop – a difficult business model to sustain” (Salter et al., 2014, p. 355). This has pushed some Western countries to allow for fast-tracked clinical trials (Figure 2) in cases where patients have no alternative treatment. In those cases the authority lies with the clinician.

Model II fast-tracks the clinical development and applications of therapies without upsetting or compromising basic research (i.e. ‘lab’ research) and product development. Model II is a model of ‘medical innovation’, as distinct from ‘scientific innovation’, where generalisable results are the end goal.

Largely in response, non-Western countries have modelled their medical innovation differently, in ways that allow therapies (and stem cell treatments) to reach patients and the market, faster than in the West.

Non-Western models

Non-Western models remain very attractive for those patients who are not eligible for stem cell treatments at home (cf. Model II). These other models of medical innovation (Model III and IV) do little clinical experimentation and have the benefit of going straight from product development to clinical trials.

“Model IV combines elements of medical innovation and scientific innovation in a single business model. Here, some of the profits from stem cell medical innovation are re-invested in the funding of the registered clinical trials” dealing with safety and efficacy required for stem cell scientific innovation, but with regard to different diseases to those addressed by the treatment available through the medical innovation activity” (Salter et al., 2014, p. 357)

There is an irony though: whilst “the vast majority of the stem cell therapy market activity is in the domain of medical innovation (Models II, III and IV), the vast majority of the official policy discourse and public commentary focuses on the domain of scientific innovation (Model I)” (Salter et al., 2014, p. 358). The UK Stem Cell Bank, the International Stem Cell Forum and the International Society for Stem Cell Research (ISSCR), and national funding research agencies, amongst others, have been providing guidance on ‘good practices’ for stem cell basic and applied research, but very little on clinical applications.

This entails that the strong demand and the ever-growing supply in the global market of stem cell therapies is constantly being ignored by policymakers and regulators who continue to support and promulgate the traditional model (cf. Model I) of scientific innovation. There is certainly a case for claiming that the conventional science-based model of innovation is increasingly ill-suited and unsustainable in increasingly global, competitive biomarkets, as is the case for stem cell therapies. 

To read about the models of innovation, click here.

Bioethical ambition, political opportunity and the European governance of patenting: The case of human embryonic stem cell science

Patenting is first and foremost a crucial component of our economic system, today. Yet, patents are also, essentially, an ‘in writing’ definition of ownership. Sheila Jasanoff (2005) notes that, in biotechnology, patents “have the effect of removing the thing being patented from the category of nature to the category of artifice - a profound metaphysical shift” (p. 204).

 “Where the patenting object involves the human embryo either directly or indirectly, this metaphysical shift can generate considerable political emotion through its engagement with a fundamental cultural symbol of human life” (Salter & Salter, p. 287). Hence, when it comes to the human body, patenting may confront significant theological and ethical opposition. In the case of Human Embryonic Stem Cell (hESC) science, the idea of ownership and commodification of the embryo has disquieted certain cultural and religious values.

Unsurprisingly then, in cases like these, the European Patent Organisation (EPO) is finding it increasingly difficult to focus solely on the technical issues of patenting. For instance, the EPO granted the University of Edinburgh a patent entitled “Isolation, selection and propagation of animal transgenic stem cells”, but this was opposed by Italy, Germany, the Netherlands, the European Parliament and Greenpeace on the grounds that it went against “ordre public [public order] and morality”, an important ethical principle of patenting law.

Such situations of cross-national valued-laden conflicts over patenting present a political opportunity for bioethics to intervene as a ‘public spokesman’ and mediator of competing interests. Already, the European Parliament has recognised that “bioethics and biological patenting are inextricably intertwined” (p. 289). Such conflicts between values of individual ownership and communal cultural values will most likely continue to emerge in patenting. There are solid grounds for believing that bioethics committees will not hesitate in seizing such political opportunities and will increasingly become an organic part of biotechnological governance.  

To read the full paper click here

Bioinformatics in the UK, China and India

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, 1999Salter, 2009aWu, 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.

To read the paper in full, click here. 

Has bioethics matured to the point where it is capable of re-orienting the relations between science, state and bioethics in the governance of science?

To answer these questions authors Brian Salter and Alison Harvey looked at the case of the production of human/animal chimeras (i.e. genetic hybrids) in scientific research. It is not a new practice: “cytoplasmic hybrids fusing human and non-human (mouse or hamster) cells were developed in the 1960s and were used in early studies mapping the human genome” (p. 688). Yet it has only recently come under ethical scrutiny. In 2011, the UK Academy of Medical Sciences (AMS) released a report entitled: ‘Animals containing human material’ (ACHM). The report had the ambition of shaping future regulation and governance of chimera use in biomedical research.  

Whereas traditionally states have used bioethics to legitimise policy-making, the case of chimeras illustrates how bioethics is becoming more of a proactive player in the mediation of state, society and science. In the case human/animal chimeras, public bioethics (distinct from academic bioethics) is actively framing the problem, the debate, and hence its solutions. Bioethical bodies in Denmark, Germany, Sweden, and in the EU, at large, have already expressed concern and interest in the issue.  

What makes current and future trends in the use of human/animal chimeras even more ethically problematic is the fact that it combines existing controversial features of scientific research: genetic modification (GM) and human embryonic stem cells (HESC). Although the introduction of human elements in animals - such as mice - are unlikely to raise issues of animal welfare, there remains the everlasting conflict of values over the ‘natural’ and the ‘unnatural’. Combined with the ethical dilemma of using of embryonic stem cells, human/animal chimeras become rather problematic.

As a solution the AMS report puts forward the concept of ‘human dignity’, arguing that respect for ‘human dignity’ may serve as the ultimate guideline in the production of chimeras, by neatly addressing both the issue of GM and HESCs. It also assures that a tight leash is kept on science and the extent to which chimeras can be made ‘human-like’. Finally, such a solution welcomes bioethics, but continues to preserve its political neutrality.

To read the full paper click here. 

To what extent does the rise of the active health consumer in the globalised knowledge economy of the life sciences challenge the hegemonic model of biomedical innovation?

For many years, the orthodox model of medical innovation has been largely accepted. This model has largely assumed that new health technologies will be delivered through the ‘lengthy innovation process of basic research, clinical experimentation, product development, clinical trials, product approval and clinical application.' (Salter et al. 2015: 156). It has been disseminated as a hegemonic model through large transnational organisations who draw upon the ‘objective’ nature of the scientific method in order to gain legitimacy. This has further been sustained by the idea that health consumers have a passive role in scientific process by contributing only through clinical trials, and once the research process is complete, receiving clinical benefits.

However, as highlighted by Salter et al.(2015), the hegemonic model is increasingly being challenged, especially in the area of stem cell science. A counter-hegemonic force has developed in which consumers of scientific-unproven stem cell therapies (often called ‘stem-cell tourists’) have become more actively involved in the bio-medical innovation. These consumers are largely accepting the practice-based model, which is a direct challenge to the orthodox model. Rather than simply providing scientifically-generalisable results, the practice-based model offers benefits for the individual patient concerned.

The emergence of this counter-hegemonic force has gained the attention of hegemonic model’s traditional intellectuals, the bioethicists. They have largely supported the orthodox model of stem cell innovation, focusing more upon taking a neutral stance, rather than positively engaging with counter-hegemonic arguments. Ethical debates have thus largely revolved around the morality behind the creation and destruction of human embryonic stem cells, and how to formulate government policy in order to ensure that this area of science is able to advance. This has resulted in the global emergence of standardised policies to address such ethical concerns.

But, with the emergence of stem cell tourism, ethical concerns have shifted. Biomedical innovation has begun to take into account the demand side of the stem cell market, and thus looking at the rights of patients to seek treatment for their diseases. Gunter highlighted that ‘no entity should withhold this fundamental right unless there is a high probability of harm to the patient’ (2010: 966). The patient is finally becoming the primary focus of stem cell innovation governance with issues such as citizen rights and consumer access finally being included in clinical decisions-making.

This counter-hegemony has emerged in a field where the orthodox model has little control. Consumers are increasingly geographically mobile, and the demand-supply relationship has been dramatically reshaped due to the high accessibility of access available over the internet. The question over the next few decades is whether or not this counter-hegemony will maintain its place, and if consumer choice will continue to challenge the logic of orthodox science.

To read the full paper click here.