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.  

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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.

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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.

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