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Mehrwertsteuer in der Schweiz. Die Handhabung im Detail. Aus der Reihe: e-fellows. Whos there? Nevertheless the share of health expenditure as a proportion of GDP has steadily grown over the last two decades in the OECD, and healthcare expenditure is under continuing upward pressure from hightechnology medicine and the demand for long-term care for a steadily ageing population Jacobzone, Simultaneously, as we discussed in the introduction, decreased fertility and the demographic shift towards an ageing population is believed to depress economic growth through increased demand on welfare and health-care provision and reduction of taxation revenues Martins et al.
One response to these pressures has been the gradual demutualization and devolution of many aspects of health care from state responsibility to individual responsibility for self-care and self-provision, through private forms of health consumption Novas and Rose ; Ericson et al. Given this configuration of tensions between the deprioritization of welfare including health , the drive to secure globally competitive industries and the emergence of global as well as national markets for therapeutic applications, states have a strong set of incentives to invest in hESC research and regenerative medicine.
If the basic science of hESC technology can be mastered and therapeutic applications commercially developed, nation states stand to reap the economic benefits associated with hosting leading-edge regenerative medicine commerce, in demand throughout global markets. It is estimated that at least million people in the United States, the EU, and Japan alone could potentially benefit from stem cell therapy of some kind Biophoenix, Over and above this, however, states may gain certain benefits of legitimacy. As Sheila Jasanoff argues, biotechnology is increasingly caught up in the political legitimacy of nation states and their abilities to deliver care and health to their citizens.
Biological science and technology projected a confident ability to take much that is mysterious, elusive, particular, and problematic in the human condition and bring it within the realms of order, prediction, uniformity, and control. The life sciences in short presented themselves as ideal instruments to states in late-modern crises of legitimation.
As we noted in the introduction, regenerative medicine has the potential to reduce disabilities associated with ageing populations and extend working life. An OECD workshop into healthy ageing identifies leading-edge biotechnological innovation as the best means to improve aged health, not only increasing longevity but also disability-free years.
Biotechnologies are revolutionising the ageing experience by offering earlier diagnoses, new treatments such as regenerative and genetic interventions and ultimately disease prevention. The workshop also noted the keen interest of large pharmaceutical companies in the area of geriatric medicine and health delivery services.
Conclusions It is evident then that hESC technologies represent a possible solution to a complex set of economic and welfare problems for contemporary states. Success in hESC research would give the sponsoring state a leading edge in the fostering of a new industry with a huge potential global market — the market for regenerative therapies. It would attract significant investment from the pharmaceutical and medical device sectors, and be a source of national scientific prestige and economic dynamism.
At the same time, it would contribute in a highly visible way to the welfare of the population, without a concomitant expansion in public service delivery. The reduction of disease burden in the elderly and disabled would help to contain health-care costs and extend active life. In the final analysis, public investment in hESC research is so attractive for states because it expresses both concern for the well-being of populations and the drive for global economic competitiveness, without any apparent contradiction between the two aims.
In the next chapter we take up these last two points in more detail, as we consider some of the material constraints on hESC research, the problems presented by the scarcity and uneven distribution of the stem cell lines themselves. In many jurisdictions, laboratory researchers have very little access to viable, well-characterized stem cell lines. The availability of hESC lines is shaped by a number of factors, including rates of ethical procurement of precursor tissues embryos and oocytes , local regulatory regimes and intellectual property configurations.
In what follows, we consider the ways these factors shape the global tissue economy of hESC research, their modes of circulation, availability and scarcity. This chapter will focus on this material and its precursors — embryos and oocytes — and elucidate the political dynamics that shape their trajectories. HESC lines are eminently flexible and robust entities — they can be frozen, passaged1 and distributed worldwide without apparent lost of efficacy. They can be standardized and benchmarked in various ways to create comparability across different lines.
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- Global Politics of Human Embryonic Stem Cell Science (Health Technology and Society Series).
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Whereas the IVF embryo is caught up in a dense web of reproduction, family relations and social controversy, a gradual process of purification — donation to clinic and then to laboratory, disaggregation, immortalization, passage — transforms the embryo into a more properly anonymized, scientific object. It becomes a neutral, validated entity, denatured of its local significance. As delocalized and anonymized scientific objects, they readily circulate through the global technoscapes of contemporary scientific research, with its high premium on international collaboration and distributed research effort.
However, the form of this circulation is highly complex and provides an interesting map of commercial interests, regulatory restrictions, public opposition or support and power relations, particularly between the developed and developing worlds. The tissue economy that precedes hESC lines is crucial for their existence; this is the sourcing of reproductive material, gametes sperm and oocytes and embryos themselves, and we focus on oocyte supply and demand in relation to the burgeoning SCNT research area. A welldeveloped global market already exists for oocytes for reproductive purposes, a market that is open to worrying degrees of exploitation of poor women who may agree to super-ovulation and oocyte harvesting for a subsistence fee.
The worldwide competition for supremacy in the stem cell field, coupled with the very large number of oocytes and embryos needed to strike a successful cell line, is bound to place even greater pressure on paid sources of reproductive material, with potentially serious risks to poor women dealing with unregulated fertility clinics.
HESC lines and biotechnology markets As we saw in the previous chapter, hESC research has received substantial degrees of public funding from a number of states. Possibilities include 1. Commercially developed therapeutic applications: The public discourse about hESC lines emphasizes their potential for tissue repair and regeneration.
However, there are currently few clinical trials for non-hematopoietic stem cells, and none for ESCs. The US company Geron had carried out toxicity trials for an hESC product to treat spinal cord injury and hopes to be in phase-one clinical trials with human subjects by Edwards, Considerable doubt remains over clinical applications in the short to medium term, and clinicians are particularly concerned about tumor formation Snyder Embryos, Oocytes, Cell Lines 37 and Vescovi, , the control of differentiation and the non-reversible nature of cellular transplant therapy.
Multiple research possibilities: Beyond therapeutic applications, hESC lines have a number of possibilities, with more prospects of immediate or imminent applications. They can be used as in vitro surrogates for studying the progression of clinical disease, and for drug screening assays, particular predictive toxicology testing. Several companies are currently engaged in developing such assays. IP and licensing: Patents can be established in the stem cells themselves or in processes involved in their isolation or culturing. Patents on stem cell lines give patent holders temporary monopolies on the commercialization of their research, allowing them to license use of their knowledge and materials for fees and royalties.
These sets of possibilities create particular flows, vectors and bottlenecks for hESC material. Rapidly expanding global interest in the commercial possibilities of hESC lines creates huge demand for wellcharacterized, uncontaminated, and standardized hESC lines. About hESC lines are estimated to be in existence worldwide Biophoenix, , but the majority of them are poorly characterized. Several consortia have formed to try to agree on characterization standards and to gather information about phenotypic and gene expression profiles, microbiology assessment and genetic identity analysis.
We explore this development in detail in Chapter 7. The IP landscape is particularly important in determining global flows of knowledge and materials in the stem cell area. Researchers who have established IP in their stem cell lines have a strong commercial advantage because they can control the ways other researchers use their knowledge, and they can earn revenue through licensing and material transfer agreements. Licenses [govern] the use of patented material or technology, which typically define the scope of use and require payment of an up-front fee plus royalties from sales of any products derived from the licensed technology, and material transfer agreements [govern] the transfer of 38 The Global Politics of HESC Science tangible research materials, with negotiable arrangements regarding the scope of research use, publications, transfer to third parties, and ownership of any technology developed.
Murray, , p. Currently the United States enjoys considerable advantage in stem cell patents, particularly for hESC lines. The EPO has interpreted the European Biotechnology Directive to mean that hESCs should be excluded on the grounds that the patenting of embryonic material is contrary to ordre public and morality and violates the non-commodity status of the human body. The European Commission is keeping a watching brief on the issue, but meanwhile, researchers within the EU must apply to individual state patent offices. The UK patent office, for example, has ruled that the embryo is not itself patentable, nor are totipotent embryonic cells that could give rise to an embryo UK Patent Office, Between and , stem cell patent applications were filed in that country, with the vast majority filed after About 20 per cent of applications filed —5 are for ESCs, and 6 of the top 30 cited stem cell patents during that period include ESC types.
The University of California holds the largest number of stem cell patents, but the most frequently cited patents are held primarily by private biotechnology firms Biophoenix, Patents can be configured in different ways, with different degrees of exclusivity. James Boyle distinguishes between low-wall and high-wall IP. Embryos, Oocytes, Cell Lines 39 Low-wall IP protects inventors without placing excessive costs on other researchers wanting to enter the field.
For example, it facilitates the sharing of basic research materials and processes at low cost. In the US ESC field, access to lines and processes has been difficult for many academic and small biotech researchers not only because of the presidential restrictions on federally fundable cell lines but also because of high-wall IP approaches by some key players. In particular, the patent filed by James Thomson, the University of Wisconsin scientist whose laboratory first cultured hESC in , exemplifies the problems of high-wall IP and the innovation bottlenecks it can create.
The patent, held by the Wisconsin Alumni Research Foundation WARF , is extremely broad, covering both the method for isolating primate and hESCs and three cell lines developed from them — neural cells, cardiomyocytes and pancreatic islet cells. A further patent claims all mesodermal, endodermal and ectodermal hESC lines, regardless of the way they were derived. Other companies could obtain only nonexclusive rights. By , only seven commercial licences had been issued Perrin, The WARF patents also applied to virtually all the cell lines available in the US National Institutes of Health NIH stem cell registry eligible for federal funding, placing further access restrictions on academic researchers Rabin, The Thomson group at Wisconsin, who successfully derived induced pluripotent stem cells in November , immediately applied for patents for the new method.
The extremely restrictive nature of the WARF patents has attracted extensive criticism, and in , a coalition of scientist and activist groups, including the Public Patent Foundation, mounted a challenge to the patents. They requested that in the absence of an ordre public test in US patent law, the USPTO re-examine the patents on the grounds that they did not fulfil the requirement for novelty and non-obviousness.
The WARF patent saga demonstrates the complex interplay of property relations and innovation ecologies, public interest and market forces in the stem cell area. The upstream, basic biology status of hESC research means that a critical mass of key researchers still subscribe to the Mertonian norms of collegial sharing, publication and disclosure rather than the high-wall IP approach adopted by WARF and Geron.
In this particular case, concern about freely circulating stem cell lines, techniques and materials has outweighed concern about shoring up strict property rights, but in the absence of a public interest test in the USPTO, nothing prevents it from granting other such broad patents. We examine the global politics of stem cell patents again in Chapter 7, when we discuss the attempts by the World Trade Organization to impose global patent standards on different national research constituencies.
Embryos, Oocytes, Cell Lines 41 State and public-sector management of hESC circulation As we saw in previous chapter, hESC research has received considerable levels of public funding; in addition to financing, public-sector involvement often takes the form of encouraging international collaboration and knowledge exchange, particularly in the early stages of basic biology research.
That governments also support measures to facilitate knowledge sharing and networking, contradicting the tendency towards privatization and commodification of the intellectual commons, points to one of the core dilemmas of the knowledge based economy.