Bioethics, patenting and the governance of human embryonic stem cell science: the European case

Professor Brian Salter

Global Biopolitics Research Group

University of East Anglia

Professor Brian Salter Global Biopolitics Research Group Institute of Health Edith Cavell Building University of East Anglia Norwich, UK NR4 6NY 0044 1603 597135 brian.salter@uea.ac.uk www.globalbiopolitics.org

Bioethics, patenting and the governance of human embryonic stem cell science: the European case

Abstract

This paper analyses the political negotiations in the EPO and European Union (EU) arenas that have accompanied the engagement between, on the one hand, the conflicting pressures surrounding the patenting of human embryonic stem cells and cell lines and, on the other, the position of bioethics in the governance response to these pressures from the European institutions with a direct and indirect responsibility for patenting policy formation and implementation. The paper is organised as follows. First, it examines the nature of the collision between economic and cultural pressures. Why is patenting economically important? How can we best theorize its relationship to its cultural context? Second, the paper explores the transnational governance response to the economics-culture tension and the possible contribution of bioethics to that response. To what extent can we conceive of bioethics as an epistemic community in pursuit of a particular agenda? Or is it rather a loose transnational network that encourages the use of similar practices in the evolution of new forms of governance? Third, how has the relationship between pressures and response been handled in the case of the EPO and the EU? What is the position of bioethics within that relationship and how has its governance contribution changed over time?

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Bioethics, patenting and the governance of human embryonic stem cell science: the European case

Introduction On 1st June 2005 the new President of the European Patent Office (EPO), Alain Pompidou, announced a halt on human embryonic stem cell patents because, as he put it, ‘there are too many ethical aspects that have not been resolved at the political level’ (Schubert, 2005: 720). Nor, since then, has the EPO found the means to resolve these ‘ethical aspects’. In November 2005 the EPO’s Technical Board of Appeal (to which the problem was referred) was also unable to determine to what extent inventions concerning human ESCs and their uses can be patented. Instead, the Board decided that it needed guidance from the EPO’s Enlarged Board of Appeal on the European Patent Convention’s (EPC’s) exclusion from patenting of inventions concerning ‘uses of human embryos for industrial or commercial purposes’ (Rule 23d(c)). And there the matter uneasily rests for the time being. Behind the present impasse at the EPO lies a complex tale illustrative of the increasingly intense politics of patenting in a global knowledge economy where the imperative of economic interest regularly collides with the priorities of cultural values. As a means for knowledge ownership and hence the realisation of knowledge value, patenting is an important legal vehicle for the pursuit of market position and economic advantage. Yet at the same time, the definitions of ownership that patenting allows and facilitates for economic purposes may well conflict with a society’s cultural understanding of what may, and may not, be owned - particularly with regard to the human body and human life. It is out of the tension between the economic and cultural dynamics that the politics of patenting are created. For as a consequence, patenting laws and agencies become the natural destination for the twin pressures of economic ambition and cultural concerns. They are the sites where often conflicting political demands are registered, insistent that resolution be found. How should governments and other political authorities respond to these demands? What forms of governance are capable of translating the separate languages of economics and culture when addressing human ESC science and its potential therapies into a common discourse where negotiation is possible and agreement achievable? At the national level, bioethics committees have to varying degrees and with variable powers sought to deal with this issue by translating the arguments into the familiar précis of formal ethical discussion (eg Nuffield Council on Bioethics, 2002; Danish Council of Ethics, 2005). They, at least, are operating within a known and reasonably familiar set of political structures. However, at the transnational level the situation is much more diffuse with numerous political loci where economic and cultural pressures can be brought to bear. And given the international nature of human ESC science and its potential global market, it is precisely in this more fluid environment that the political heat is developing most rapidly. Given this context, the objective of this paper is to analyse the political negotiations in the EPO and European Union (EU) arenas that have accompanied the engagement between, on the one hand, the conflicting pressures surrounding the patenting of human ESCs and, on the other, the governance response to these pressures from the

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range of European institutions with a direct and indirect responsibility for patenting policy formation and implementation. In pursuit of that objective, the paper is organised as follows. First, it examines the nature of the collision between economic and cultural pressures. Why is patenting economically important? How can we best theorize its relationship to its cultural context? Second, the paper explores the transnational governance response to the economics-culture tension and the possible contribution of bioethics to that response. To what extent can we conceive of bioethics as an epistemic community in pursuit of a particular agenda? Or is it rather a loose transnational network that encourages the use of similar practices in the evolution of new forms of governance? Third, how has the relationship between pressures and response been handled in the case of the EPO and the EU? What is the position of bioethics within that relationship and how has its governance contribution changed over time? Patenting, culture and morality In their 2005 report Intellectual property as an economic asset: key areas in valuation and exploitation, the EPO and the Organisation for Economic Cooperation and Development (OECD) argue that in the global knowledge economy an increasing share of the market value of firms derives from their intellectual assets. They continue,

As firms shift to more open models of innovation based on collaboration and external sourcing of knowledge, they are exploiting patents not only by incorporating protected inventions into new products, process and services, but also by licensing them to other firms or public research organisations (PROs). Moreover, they are using patents as bargaining chips in negotiations and as a means of attracting external financing from banks, venture capitalists and other sources. (EPO and OECD, 2005: 3)

Pursuing this economic logic, intellectual property rights (IPR) are regarded as an essential component of this kind of economy because they commodify the intangible capital of knowledge, generate value and facilitate trading. Without IPR, and in particular patent protection, emerging markets would find it difficult (or more difficult) to develop since the tangible product has yet to appear and economic value is embedded in the potential application of the knowledge. This problem is particularly acute in high-tech and research based Small to Medium Enterprises (SMEs) for whom their IPR is their main asset. The economic significance of patents is further enhanced by the need for new forms of knowledge to compete for attention in an increasingly global venture capital market with its own clear demands: investors, often institutional investors, make their decisions in the light of the patents held by companies (Florida and Smith, 1990; Florida and Samber, 1999; Haemmig, 2003). For capitalisation of a new knowledge market to occur, then, investors need to be reassured that the value of the knowledge, as opposed to the value of the eventual product, is in the hands of the company concerned. (Evidence of the relationship between patents and financial markets is shown in the responsiveness of stock prices to both the issuing of new patents and the number of patents owned by a company (Coriat and Orsi, 2002: 1501; Zeller, 2005: 17).) Investors are likely to be particularly sensitive to the patenting issue in high risk

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areas such as the early stage development of health biotechnologies where the science is very new and the potential therapies very distant. In a perfectly rational world where economic arguments dominate, the political implication of this logic is that states will seek to adjust their patenting policies to enable more knowledge to be patented more efficiently with the intention of maximising their capacity to compete effectively in the global knowledge economy. Patenting policy will be harnessed to the national interest. Further, that having made the domestic policy adjustment themselves they will then apply international pressure for the harmonisation of inter-state patenting policies along lines consonant with their national approach. Whilst perhaps not perfectly rational, we can see that in the important case of the United States (US), for example, an early adjustment was made to accommodate this logic in the field of health biotechnology. In its 1980 decision on Diamond v Chakrabarty, the US Supreme Court ruled that a living organism (in this case a bacterium of the genus pseudomonas modified using molecular techniques) could be patented. In general, it commented, patents could be granted for ‘anything under the sun that is made by man’ and in this respect living organisms are not exceptional (Jasanoff, 2005: 49) – a generous view of intellectual ownership. Other states have been less persuaded that the knowledge property generated by the life sciences should be so broadly interpreted. In 2002, Canada’s Supreme Court rejected Harvard University’s application for a patent on its oncomouse (a mouse with a cancer promoting gene) on the grounds that higher life forms are distinctive and transcend the patenting definition of ‘composition of matter’ (Nador and Loucaides, 2003: 7). Although individual states may resist the economic logic of patenting so comprehensively embraced by the United States, the national level is not the only, nor necessarily the most critical, political site where the conflict over the appropriate definitions of ownership of the products of the life sciences takes place. Three international bodies have provided a continuing target for political pressure through their attempts to promote the international harmonisation of patenting rules: the United Nations’ (UN’s) World Intellectual Property Organisation (WIPO – established in 1967), the World Trade Organisation’s (WTO’s) Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) and the European Patent Office (EPO – of which more later). The creation of TRIPS in 1994 by the Final Act of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT) was in large part a response by developed countries, and in particular the United States, to the manoeuvrings of developing countries within the WIPO during the 1970s and 1980s seeking to resist international encroachments on their sovereign intellectual property rights. TRIPS drastically limited their political space in two ways. First, it tied membership of the WTO (which most developing countries wanted and needed) to agreement on TRIPS. (Currently 144 states are members of the WTO and therefore signed up to TRIPS). Second, it set detailed and mandatory harmonising standards of intellectual property law on the ownership of two major technologies: digital technology and, importantly, biotechnology (Drahos with Braithwaite, 2002:10-17). The struggle over the TRIPS agenda illustrates that even the economic logic of patenting regulation is less than neutral when political interest is included in the equation: a country’s approach to the global harmonisation of patenting will be influenced by the strength or weakness of its competitive position in the international

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economy. For example, at the insistence of India, Argentina, Brazil, and Turkey, all of whom sought to protect their own industries, TRIPS contains a 10 year delay for the institution of pharmaceutical and agricultural chemical patent protection in developing countries. At the same time, international science was becoming less than enamoured with an economic justification of a form of patenting that in its view has the effect of either restricting the free flow of scientific information or restricting that information to those prepared to purchase the appropriate license from the patent holder. It should be remembered that the TRIPS agreement was signed at a time in the mid-1990s when the Human Genome Programme (HGP) was strongly promoting the open science model (HUGO, 1995; see also Royal Society, 2003). In this context, the issuing of patents on research tools such the oncomouse granted to Harvard University (subsequently handed over to Dupont Corporation as part of an exclusive licensing arrangement) and the breast and ovarian cancer gene to the University of Utah, the National Institute of Health (NIH) and Myriad Genetics (which enjoys exclusive rights to the exploitation of all of the benefits that can be derived from diagnosing the gene) created the strong suspicion among scientists that ‘disproportionate and overlapping patent grants [were] gluing up the research world’ (Cornish et al, 2003: 19). In their report Intellectual property rights and genetics to the United Kingdom’s (UK’s) Department of Health, the authors expressed the fear that as a result of the US-style of approach to patenting in the knowledge market of new health technologies:

the cost of care will increase; that patients will be deprived of access to new techniques and drugs; that research and testing tools will be withheld; that researchers and carers will not share information; that research will become too complicated to enter upon (perhaps because of the so-called “anti-commons effect” if there being too many right holders); and equally there could be premature commercialisation in the race to get ahead (Cornish et al, 2003: 19).

Here we can see that the debate about the relationship between patents and economic advance is emphasising as important factors other than those that contribute to the efficiency of the patents-innovation linkage. Perhaps unsurprisingly, the political agenda of patenting harmonisation is broadening as the pure economic arguments (contested though they may be) are supplemented by cross-cutting discourses about rights (eg who should have access to the new health technologies) and, as we shall see, ethics (what is the moral basis of patenting?). The future global politics of this field were to be greatly influenced by the extent to which these broader, cultural factors were able to penetrate the key decision and policy making arenas. But to take a step back and reflect on the socio-cultural significance of patenting, Jasanoff suggests that patents order the process of invention in ways that are ‘intrinsically political’ because their extension ‘to new domains alters basic notions of what is a commodity and who can assert ownership over it.’ 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’ (Jasanoff, 2005: 204). We have already seen in the Canadian case that the act of commodification of biotechnological knowledge for private purposes may indeed be perceived as culturally significant, particularly where human and animal life is the subject. As the international debate over patenting has progressed, so the reservations regarding the

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universal applicability of the economic logic of patenting have increased, matched by a growing awareness of the range of alternative perspectives that may have a legitimate place in the formation of patenting policy. Within the TRIPS Agreement, the recognition that non-economic factors may have a proper role to play in patenting policy finds expression in its Article 27 where the Agreement states:

Members may exclude from patentability, inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by law.(paragraph 2) (Nuffield, 2002: 79)

Other permitted exclusions include ‘diagnostic, therapeutic and surgical methods for the treatment of humans or animals and plants and animals other than micro-organisms’ (paragraph 3). But for these exclusions to have international political impact there would need to be sustained pressure for their activation. That pressure has emerged in large part through a challenge to the assumption behind the economic approach to patenting that knowledge is a private rather than a public good. In this context the function of patenting is to facilitate the ability of the individual to maximise the economic benefits of knowledge ownership. Against this has developed the alternative view that knowledge is a public or communal good and that the use of patenting as a market mechanism is less important than its contribution to the achievement of certain human and cultural rights (for example, health, human dignity, cultural identity) (Drahos, 1999; 2002). For the supporters of TRIPS and the US style of patenting (bearing in mind that US patent law has no morality clause), it has been important to limit the strength of this challenge by trying to keep human rights and its associated ethical arguments contained in a separate policy silo. To bring the two policy streams together at the international level, it was believed, would undermine the principles of the global knowledge economy that TRIPS was set up to protect by rendering the application of those principles relative to other, ethical priorities. However, the HIV/AIDS epidemic and the imperative for developing countries to ensure their population’s right of access to medicines by resisting the rise in drug prices that accompanied the implementation of TRIPS forced a reappraisal of this separatist approach (Cullet, 2003). Nor is it simply a developing country issue. Citizens in developed countries are likely to be equally energised if they see patenting laws as depriving them of what they consider to be their health care rights. O’Connor predicts that in the United States the promise of stem cell research of cures for cancer, diabetes and Alzheimer’s disease means that the pitch of the ownership battle will rise proportionally to the success rate of the research. He continues: ‘the public’s claim to reasonable access to any crucial life-saving medical breakthroughs that do arise from stem cell research may well force federal, state or local officials to circumvent the existing political opposition to compulsory licenses in the United States’ (O’Connor, 2005: 666). In addition, the Universal declaration on the human genome and human rights in 1997 by the International Bioethics Committee (IBC) of the United Nations

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Educational and Cultural Organisation (UNESCO) initiated a global debate about the moral status of the human body and human life and their relationship to the market that is still gathering political speed in both bioethical and policy making circles worldwide (Salter, 2005). At the conclusion of its 8th Session on 14th September 2001 the IBC adopted by consensus an Advice on the patentability of the human genome which states that ‘there are strong ethical grounds for excluding the human genome from patentability’ and further recommends ‘that the WTO, in its review of the TRIPS Agreement, clarify that, in accordance with the provision of Article 27(2)1 (the morality clause), the human genome is not patentable on the basis of the public interest considerations set out therein, in particular, ordre public, morality and the protection of human life and health’ (European Group on Ethics, 2002: 56). Ethical discussions about the status of DNA, the human embryo, human dignity and the commercialisation of the human body - often subsequently enshrined in national legislation and, in the case of the Council of Europe’s Convention on human rights and biomedicine, in a protective international agreement - now form an internationally salient discourse with which patenting policy and practice is obliged to engage. At the same time other international developments, and in particular the Convention on biological diversity, have emphasised the importance of the communal ownership of knowledge as a counterbalance to what some have termed the ‘biopiracy’ of the developing world’s knowledge by Western countries and companies sailing under the TRIPS flag that champions the individual ownership of knowledge (Sell, 2005: 6). Constructing governance Given this context, the governance problem can be seen as one centred on the construction of procedures that would enable productive engagement between the plurality of moralities accompanying the economic and cultural arguments surrounding patenting at the international and national levels. In her study of the problematic treatment of biotechnology in the UK, US and Germany, Jasanoff notes the dawning recognition in all three political systems that some of the risks and promises engendered by the multifaceted advances in genetics and biotechnology (particularly those associated with fears of ‘playing god’),

called for a new language of deliberation, geared to the analysis of human values rather than the benefits of the market, the facts of science, or the norms of law. The language that actors seized on for this purpose was a branch of moral philosophy, specifically, bioethics. Combining life (bios) and moral custom (ethos) in a single portmanteau word, bioethics offered the promise of bringing order and principle to domains previously governed by irrational, emotive and unanalysed reactions. (Jasanoff, 2005: 171. Emphasis added.)

What we have here, then, is the identification of the political need for a new form of expert, the bioethicist, able to deal with the novel governance problems posed by biotechnology. Where should we situate this actor in the governance literature? Studies on the role of expertise in policy making, particularly in the fluid political environment of the European Union (EU), has shown how knowledge can shape policy formation (Richardson, 1996). The EU’s decision making system relies extensively on a plethora of working groups, standardisation bodies, and committees that draw on the

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knowledge of experts (Radaelli, 1998). However, these ‘technocrats’, as they have become known, have their political limitations. Radaelli observes that ‘the technocrat believes that rational analysis and scientific examination of the facts will bring about unanimous consensus on policy solutions’ (Radaelli, 1999: 760). But this confidence assumes a high degree of certainty in the knowledge situation. ‘By contrast’, Radaelli continues, ‘the technocrat feels uneasy under conditions of political conflict, ideological debates, and controversies on the distributive issues of justice’ – precisely the conditions of uncertainty prevailing in the interaction between biotechnology and its cultural locale. So if the bioethicist is new kind of expert, one able to deal with ethical uncertainty and offer advice but not an expert who is yet a fully fledged technocrat in the sense of being routinely integrated into the machinery of the EU’s transnational government - how can we conceptualise this political role? In their study of the politics of biobanks, Salter and Jones explored the extent to which bioethics can be construed as an epistemic community in terms of the definition posited by Haas of ‘a network of professionals with recognised expertise and competence in a particular domain and an authoritative claim to policy-relevant knowledge’ within that domain (Salter and Jones, 2005; Haas, 1992: 3; see also Verdun, 1999 and Haas 2001). Broadly speaking, the conclusion of the study was that bioethics is a community divided by the different professional backgrounds of its members and united by the common legitimating function they may be called upon to perform in the consideration of ethical issues surrounding the governance of biobanks. Bioethics employs a common language of ethical analysis but that language is delivered by professionals from differing backgrounds. Indeed, other work on national bioethics committees has shown that here multi-disciplinarity is regarded as a strength and the absence of members specifically trained in bioethics is clearly not regarded as a weakness (Galloux et al., 2002). In other words, the business of bioethical regulation may require a particular expertise but it is one which, it is believed, can be acquired through serving an apprenticeship in the practical trade of committee work and ethical problem solving rather than through acquiring the formal ethical knowledge of philosophical training. Given this mix of backgrounds in the bureaucratic identity of bioethics, it may be more appropriate to describe bioethics not as a single epistemic community but, as Rosenberg observes, as a bioethical enterprise comprising ‘a conglomerate of experts, practices, and ritualised and critical discourses in both academic and public space’ (Rosenberg, 1999: 40). It is the political utility of this enterprise and the common adherence of its members to principles and procedures that can produce a usable decision that constitutes its principal identity and strength within the global moral economy (Evans, 2000 and 2002). If its epistemic identity is less than coherent, can bioethics nonetheless be considered a transnational network in the sense that it contributes to the process of ‘governance without government’ through non-hierarchical forms of steering by private actors and the creation of non-state forms of political order (Rosenau and Czempiel, 1992; Young, 1999; see also Etzioni, 2001; Ronit and Schneider, 1999)? Within this broad concept, bioethics is clearly a particular type of transnational network, not oriented to the advocacy function of governance (the definition of problem and agenda) as

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portrayed by Keck and Sikkink, for example, but rather to the production of a policy or decision making solution (Keck and Sikkink, 1998). As Rosenau describes the contribution of such a network, ‘Here governance is conceived as systems of rule, as the purposive activities of any collectivity that sustain mechanisms designed to insure its safety, prosperity, coherence, stability and continuance’ (Rosenau, 2000: 171). It is what he terms a ‘horizontal network’ with authority embedded in the informal rules through which it conducts its affairs (Rosenau, 2000: 191). Interestingly, this view of transnational networks is very close to Young’s conceptualisation of regimes where there is an additional emphasis on the regulatory (formation of rules) and procedural (mechanisms for arriving at collective choices) governance functions – characteristics that resonate strongly with the self-appointed tasks of the transnational bioethics network (Young 1999: 5-6). It raises the important issue of how the legitimacy of a network is established in order for these governance functions to be successfully delivered (Hurd, 1999). What is the source of legitimacy for this particular form of non-hierarchical steerage? It is relevant to note here Risse’s comment that the legitimacy of a rule can result not only from beliefs in the moral validity of the norm itself but also ‘from beliefs in the validity of the procedure by which the rule has been worked out’ (Risse, 2004: 5). In the case of bioethics, the utilitarian commitment of its transnational network of societies, conferences, and committees to the production of policy relevant advice through a procedure of expert bioethical discussion does generate procedural legitimacy. However, it is one that is characterised by a matrix of national cultural differences. In her work on the relationship between cultural traditions and the formation of policy on stem cell research, Hauskeller shows how ‘the predominant type of ethical reasoning in a nation or culture finds expression in social and political decisions and practices’ (Hauskeller, 2004). Across Europe, styles of ethical reasoning differ considerably and thus so also does the character of the legitimacy of the bioethical rule formulation process when dealing with human ESC science (Bender, Hauskeller and Manzei, 2005; see also Beckmann, 2004 (Germany); Maio, 2004 (France); Mauron and Baertschi, 2004 (Switzerland); Schmidt et al, 2004). It is likely, therefore, that within the transnational network of bioethics there are competing national modes of bioethical discourse and legitimation. The transnational politics of stem cell patenting in Europe In Europe, the transnational governance challenge created by the clash between, on the one hand, the private ownership requirements of an unrestricted global knowledge economy of human ESC science and, on the other, the communal values of local cultures has been manifest through the continuing political negotiations surrounding the two international agreements for the regulation of patenting in this field: the Council of Europe’s 1973 European Patent Convention (EPC) and the EU’s 1998 Directive on the legal protection of biotechnological inventions (Directive 98/44/EC). The relationship between the two is an interesting compound of legal and political elements. Neither the EPC nor its administrative arm, the European Patent Office (EPO) are EU institutions but have a quite separate legal identity. However, all EU Member States have ratified the EPC (as have several non-EU states, notably Switzerland). In addition, in 1999 the EPO stated that it would use the Directive as a supplement to interpretation of the EPC and included it in its Implementing Regulations (Baldock

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and Kingsbury, 2000). In any case, regardless of the legal niceties, the institutions of the EU, particularly the European Parliament, have always treated the EPO as the inhabitants of a common political territory. If a political point needs to be made and pushed on patenting the Parliament has never been inhibited by the technical limits of its jurisdiction. As the cultural questions surrounding human ESC science have increased, so the EPO has become a target for these pressures and has found it difficult to maintain its direction as an impartial regulatory body concerned with purely technical patenting issues. As with the TRIPS agreement, the EPC contains a clause designed to allow the expression of arguments about values within the patenting decision making process. Article 53(a) states that European patents shall not be granted in respect of:

Inventions the publication or exploitation of which would be contrary to ‘ordre public’ or morality, provided that the exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States (EPO, 2006).

Specifically excluded by Article 53(b) are ‘plant or animal varieties or essentially biological processes for the production of plants or animals; this provision does not apply to microbiological processes or the products thereof’ (EPO, 2006). As cases have arisen that have activated opposition on the basis of ‘ordre public’, so the EPO has attempted to refine its interpretation of this concept on a case by case basis. The leading EPO Board of Appeal decision in this respect relates to a dispute in 1995 between Plant Genetic Systems (PGS) and Greenpeace where the Board reached the following conclusion.

In the opinion of the Board the concept of morality is related to the belief that some behaviour is right and acceptable, where other behaviour is wrong, this belief being founded on the totality of the accepted norms which are deeply rooted in a particular culture. For the purposes of the EPC, the culture in question is the culture inherent in European society and civilisation. Accordingly, inventions the exploitation of which is not in conformity with the conventionally accepted standards of conduct pertaining to this culture, are to be excluded from patentability as being contrary to morality. (EGE, 2002a: 43)

Unsurprisingly perhaps, the explicit inclusion of cultural norms as a legitimate part of decisions about what knowledge can be patented and what not, opened the way for a further political debate about how you decide what cultural norms are relevant and what not: essentially ethical questions. By this action the EPO enlarged its governance role in an area with which it was ill-equipped to deal. Prior to the arrival of the human ESC patenting issue, the governance limitations of the EPO were starkly revealed by two patenting applications with strong cultural overtones: the Harvard oncomouse and Myriad Genetics and its genetic test for the cancer genes BRCA1 and BRCA2. After 7 years of dispute centred around Articles 53(a) and 53(b), Harvard University was granted a patent for its transgenic mouse in 1992. However, there was no commitment to the patenting of transgenic animals in general but rather the creation of a precedent for the case-by-case review of the ethical

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issues surrounding animal patenting (Jasanoff, 2005: 219). Reflecting on the EPO’s ability to deal with the ethical issues involved in the case, the Nuffield Council on Bioethics noted that ‘the scrutiny of patent applications by reference to their being contrary to morality or “ordre public” requires expertise in areas that may not be represented in patent offices’ such as moral philosophy, environmental ethics and public policy’ (Nuffield Council on Bioethics, 2002: 35). For a decade from 1995 onwards, Myriad Genetics was involved in a similarly contentious dispute that severely tested the EPO’s procedures (Rimmer, 2003; see also Cornish et al: Appendix 8). Paralleling the politicisation of patenting at the EPO, was the long and arduous gestation of the directive on the legal protection of biotechnological inventions. Both experiences reveal the extent of the political need for a new form of governance capable of dealing with the cultural intricacies stimulated by any attempt at ownership of the human body and human life. Commencing in October 1988, the Commission’s bid to harmonise Member States’ legislations with regard to the patentability of inventions which make use of biological material as a measure in support of the single market took nearly 10 years to reach fruition, arriving on the statute books on 6th July 1998 as Directive 98/44/EC. During the intervening decade, the formal and informal position of ethics in the debate surrounding patenting policy matured considerably. As the first international text to deal specifically with biotechnological inventions, the Directive was also the first to engage systematically the range of possible European cultural responses. Formal recognition of the need to address the ethical content of the debate through a separate governance initiative came in 1993 with the request from the Commission for a report from the Group of Advisers on the Ethical Implications of Biotechnology to the European Commission (set up by the Commission in November 1991) on the ethical questions arising from the proposed Directive. In producing its Opinion, the Group observed that ‘in the discussions on the Directive, ethical considerations now outweigh the purely legal and economic concerns’ (Group of Advisers, 1993: para 1.4). Within the governance machinery of the EU, ethics had taken its first small step to becoming institutionalised: its effect was to begin a slow process of routinising the inclusion of a new form of expertise in the process of EU policy formation. Perhaps unsurprisingly, in this early Opinion of the Group there is a degree of self-consciousness about the significance of the shift that is taking place as it points out that the concept of ‘human dignity’ appears for the first time in Community law in the Directive drafts, observing that this ‘is an indication of the concern aroused by certain developments in the fields of human genetics and medicine’ (Group of Advisers, 1993: para 2.2.3). That concern was such that the European Parliament rejected the proposal in March 1995. No doubt in response to that debacle, the Group of Advisers was asked by the Commission to produce two further Opinions: the first, on the genetic modification of animals and, the second, on the patenting of inventions involving elements of human origin (Group of Advisers, 1996a and 1996b). In the latter, the Group effectively redefined the concept of patenting, insisting that it must contain an ethical dimension. The Directive, it maintained,

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must give sufficient guarantee so that refusal to grant a patent on an invention in so far as it infringes the rights of the person and the respect of human dignity should be legally founded. Consequently, the consideration of patentability criteria resulting from the usual technical requirements of novelty, inventive step and industrial application, must also take into account consideration of these ethical principles. (Group of Advisers, 1996b: para 2.1., emphasis added)

An immediate consequence of this redefinition was the exclusion of patents on the human body on the basis of not only the usual conditions of patentability but also the ethical principle of non-commercialisation of the human body (Group of Advisers, 1996b: para 2.3.). The political rise of ethics as a legitimate part of the policy discourse about patenting found expression in the subsequent 1998 Directive in several ways. First, the role of the European Group on Ethics in Science and New Technologies (EGE – established as successor to the Group of Advisers in November 1997) was formally incorporated into the Directive as both recital and article. Thus Recital 19 notes that account has been take of Opinion No 8 of the Group of Advisers and Recital 44 and Article 7 state that the EGE ‘evaluates all aspects of biotechnology….including where it is consulted on patent law’ (European Parliament and Council of Ministers, 1998). Second, the importance of ordre public and morality as an integral part of patenting decisions is reiterated at several points including Recital 36 (incorporating Article 27 from TRIPS) and Recital 39 (the significance of ordre public and morality as defined by Member States). Ordre public and morality then form the basis for Article 6 and the consequent exclusion of:

(a) processes for cloning human beings; (b) processes for modifying the germ line genetic identify of human beings; (c) uses of human embryos for industrial or commercial purposes; (d) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from this process.

Finally, the Commission is required by Article 16 to produce a five yearly report ‘on any problems encountered with regard to the relationship between this Directive and international agreements on the protection of human rights to which Member States have acceded’. The agreement on the biotechnology Directive and its incorporation into the Implementing Regulations of the EPO not only consolidated the general position of ethics as a factor in European patenting decisions but also provided specific guidance on the treatment of patent applications involving the human body, gene sequences, cloning, human embryos and genetic modification. It is therefore no coincidence that five months later the University of Edinburgh ran into a considerable political storm when Patent No. EP 0695351 entitled ‘Isolation, selection and propagation of animal transgenic stem cells’ was granted to it by the EPO. The patent was challenged on the basis that its claims extended to a method of somatic cell nuclear transfer in ‘animals’ and that this included ‘humans’. Unusually, fourteen different opponents registered their objection to the patent on the grounds of ordre public (Article 53a of the EPC)

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including the governments of the Netherlands and Italy. Demonstrations by Greenpeace coupled with national and international press coverage rapidly politicised this part of the stem cell field. Equally significant was the reaction of the European Parliament. On 30th March 2000 it passed a resolution stating that it was ‘deeply shocked’ at the granting of a patent that included techniques which allowed the genetic modification of the germ line of human embryos and which could be used for the cloning of human beings (European Parliament, 2000). It called on the EPO ‘to ensure that all….patent applications in Europe do not violate the principle of non-patentability of humans, their genes or cells in their natural environment…’. Furthermore, demonstrating that it was prepared to enlarge the terms of the conflict to include the role of the EPO itself, it observed that the EPO is ‘a body acting as both judge and jury whose powers and procedures must be reviewed’. Parliament’s response to the EPO’s decision is not unexpected when seen in the context of its ethically based policy narratives on biotechnology, particularly with regard to the human embryo. For example, in 1993, 1997 and 1998 Parliament had passed resolutions opposing cloning of the human embryo, supporting the Convention on human rights and biomedicine and calling on Member States to introduce a legally binding ban on the cloning of human beings (European Parliament 1993, 1997 and 1998). Another Parliamentary measure, Directive 98/79/EC on in vitro diagnostic medical devices makes it clear that ‘the removal, collection and use of tissues, cells and substances of human origin shall be governed, in relation to ethics, by the principles laid down in the Convention of the Council of Europe for the protection of human rights and dignity of the human being with regard to the application of biology and medicine’ (EGE, 2000: para 1.14). In addition, the decade long gestation of the biotechnology Directive and its formal incorporation into EPO decision making had ensured a continuing Parliamentary interest in the particular ethics of the patenting of the human body. The Edinburgh case was not a one off. Eighteen months after the Edinburgh resolution Parliament again took the EPO to task in a resolution opposing the granting of a patent to Myriad Genetics for the BRCA1 and BRCA2 breast cancer genes and again called for a review of the operations of the EPO (European Parliament, 2001). So far as the politics of the European Parliament are concerned, then, ethics and biological patenting are inextricably intertwined. Moreover, in the case of human embryonic stem cell science the power of the relationship is multiplied where the ethics of ownership combine with the ethics of the human embryo to produce a potent political brew. Although the reality of cultural conflict between the values of the Member States had, with the able assistance of the European Parliament, ensured the engagement between ethics and patenting in practice, a further political step was required by an authoritative body to explain and formally legitimise the link between ethics and patenting in principle. In May 2002, the European Group on Ethics – the body charged by the biotechnology Directive to evaluate ‘all ethical aspects of biotechnology’ – published its Ethical aspects of patenting inventions involving human stem cells where it argues that modern patent law has always had an ethical dimension since its inception at the end of the 18th century (EGE, 2002b). Underpinning that dimension, the EGE maintains, is the negotiation of a ‘social contract’ between inventors and society at large where it is ‘necessary to secure the

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right balance between the inventor’s interests and the society’s interests – in the sense that one task for the community is to secure ethical principles and values in the context of possible conflicting interests of stakeholders’ (including patients associations and industry but not, interestingly, religion!) (EGE, 2002b: para 2.2). Having thus provided a general justification for the inclusion of ethical principles it is then but a small step for the EGE to recommend that ethical evaluations be included in the examination of patent applications by national patent offices and the EPO through the use of advisory panels of independent experts (EGE, 2002b: para 2.10). In terms of ambition at least, ethical power has here assumed a bureaucratic dimension. However, others were less convinced that bioethics, and bioethicists as an expert group, should form an integral part of the governance arrangements of the patenting field. Given the sensitivity of the patenting of biotechnological inventions, Directive 98/44 had included an Article 16c that requires the Commission to establish an Expert Group on Biotechnological Inventions with the brief to monitor ‘the impact of patent law on biotechnology and genetic engineering’ and provide regular reports. In its first report, the Expert Group identifies the patentability of human stem cells and of cell lines obtained from them as a particularly difficult issue (European Commission, 2002a). In its second 2005 report, a difficult issue had become an intransigent one because, in the Group’s view, the question of patenting was closely linked to the definition of what constitutes an embryo, and the scope of research allowed as determined by national legislation. It continued:

In the light of the clear divergencies which currently exist between Member States as regards the acceptability of research relating to embryonic stem cells, the continuing and rapid developments in this field, and the fact that the Directive itself provides for Member States to refuse patents on grounds of ordre public or morality under Article 6(1) [of the biotechnology Directive], the Commission considers that it is premature to give further definition or provide further harmonisation in this area. At the same time the Commission will monitor developments taking into account both the ethical aspects and the potential impact on competitiveness. (European Commission, 2005: para 2.2, emphasis added)

Yet its capacity to extend its governance function to include the ethical dimension is limited by its composition: experts from the patent profession, patent practitioners (from the private sector, big business and a small biotech), three legal experts, two scientists and representatives from the EPO and the WIPO, but no bioethicists (European Commission, 2004: v). The formal linkage between the EU’s biotechnology Directive and the EPC’s Implementing Regulations ensures that they share governance concerns (whether they like it or not) when interpreting the relationship between patenting and ethics. Returning now to the Edinburgh case, it is therefore apparent that decisions about the patentability of human ESCs and ESC lines were bound to be influenced by the ethical discussions taking place elsewhere in the Commission, Parliament and the EGE. Politically speaking, this is a highly permeable as well as a highly charged field. Thus when the EPO Opposition Division ruled on the University of Edinburgh patent application in July 2002, it asserted that any claims involving human ES cells

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violated the European Patent Convention’s rule 23d(c) that excludes uses of human embryos for industrial and commercial purposes from patentability (EPO, 2002). The knock-on effect was immediate with patent examiners using the decision as a precedent to reject an application concerning James Thomson’s technique for driving primate ES cells from the Wisconsin Alumni Research Foundation (WARF) (Vogel, 2004). Other applications from the California Institute of Technology on a method to isolate neural stem cells from embryonic tissue and from the University of Bonn on a method to differentiate neural cells from mammalian ES cells also remain unresolved. As a result of appeals from the University of Edinburgh, the decision on the principle of human ESC patenting now rests with the EPO’s final authority, the Enlarged Board of Appeal, a process which may take several years. As a consequence, the future value of hESC science remains an unknown and thus the potential market in which biotechs and venture capitalists might invest a present unreality. Conclusions The European case demonstrates with revealing clarity the political complexities of constructing, knowingly or otherwise, a governance response to the conflicting economic and cultural priorities generated by the question of ownership in the field of human embryonic stem cell science. On the one hand, as its strategy document Life sciences and biotechnology makes clear, the EU is formally committed to becoming a leading player in the global knowledge economy of the life sciences. On the other, as the same document also notes, ‘scientific and technological progress will continue to give rise to new ethical or societal implications’ and these, the Commission expansively observes, ‘should be addressed pro-actively and with a broad perspective, taking into account the moral obligations towards present and future generations and the rest of the world’ (European Commission, 2002b: 13). But what, in terms of the governance arrangements of patenting, does, or could, ‘pro-actively’ mean? The global experience is that there is an inherent tension between the individual ownership rights necessary for the operation of international markets in biotechnology and the communal values of the many cultures in which such markets operate. Which values should take precedence and why? In this context, the specific governance issue then centres on the means that could be used to negotiate the inevitable plurality of economic and cultural moralities that may shape policy on patenting. A new type of expertise and authority is required capable of ordering, reconciling and, ideally, resolving the sensitive ownership disputes inherent in the development and application of the life sciences. The convenient emergence of bioethics as a claimant for this new governance territory seemed to promise a way forward. In her study of biotechnology in the UK, US and Germany, Jasanoff suggests that bioethics provides a ‘language of deliberation’ capable of addressing the novel tensions generated by the unique possibilities of the new science: ‘Despite its academic connections to philosophy, bioethics was seen in all three countries as a device for bridging potentially troublesome divides: among disciplines, professions, and institutions; and increasingly also among science, state and society’ (Jasanoff, 2005: 188). Although the national philosophical traditions and origins of bioethics may vary, there is a common utilitarian emphasis on the identification of ethical procedures that may be used to address conflicting moral positions. Furthermore, as a transnational network, the ascent of bioethics has been

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marked by the emergence of a global infrastructure: high profile ethical statements launched from the platform of established international bodies, an awareness of the need to translate these statements into legal/bureaucratic form, and the proliferation of horizontal and vertical networks linking international and national levels of ethical governance. It may not have the coherence of a fully developed epistemic community but this does not appear to restrict its ambition to act as a form of biotechnology governance. However, the European experience of patenting policy in the field of human ESC science shows the importance of Haas’s observation that the political advancement of such a community is dependent on ‘the extent to which an epistemic community consolidates bureaucratic power within national administrations and international secretariats’ and thus is able ‘to institutionalise its influence and insinuate its views into broader international politics’ (Hass, 1992: 4). This is important because in the EU bioethics is thus far relying largely on a strategy of governmental institutional penetration rather than on providing support to the ‘private governance’ of science itself (see eg Ronit, 1999). Advances have undoubtedly been made. Recognition of the need for a routinisation of the ethical conflict over the patenting of biotechnological inventions in general, and human ESCs and cell lines in particular, became unavoidable with the decade long debate over Directive 98/44/EC and the long running disputes resulting from the activation of the EPC’s public ordre Article 53a and its Rule 32d(c) on the ‘uses of human embryos for industrial or commercial purposes’. The creation of the Group of Advisers on the Ethical Implications of Biotechnology to the European Commission in 1991 and its successor body the European Group on Ethics in Science and New Technologies in 1997, their statutory incorporation as the EU’s ethical experts and their formal contribution to the debate on patenting shows the initiation of a bioethical bureaucratic presence. Yet at the same time the EPO has resisted suggestions that it should formally include bioethicists in its examining and review procedures, being content to rely on its existing definition of relevant ‘experts’. Hence we find the European Parliament in 2005 obliged to reiterate its previous request that the EPO set up a body which ‘checks patents that are sensitive from an ethical point of view before they are granted’ (European Parliament, 2005). As a form of governance without government in the arena of European patenting policy, therefore, bioethics can best be described as a horizontal network, exercising a form of steerage through rule setting, and drawing for its authority on the claim that it is using an ‘objective’ set of procedures in reviewing ethical arguments. If in the future the bioethics network can achieve a bureaucratic presence in the EPO’s decision making process as well as that of the EU then its legitimacy, and its power, will be considerably enhanced. It will, of course, encounter opposition from the resident technocrats of the EPO but their inability to resolve the present stalemate and uncertainty over the patenting of human ESCs and cell lines renders them politically exposed to pressures from scientists, industry and venture capitalists.

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