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

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.