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Chapter 8

Policy Entrepreneurs and Morality Politics: Learning from Failure and Success

Michael Mintrom

Introduction

In this volume, political entrepreneurs are viewed as special actors, embedded in the socio- political fabric, who are alert to the emergence of entrepreneurial opportunities and act upon them (see Petridou, Narbutaité Aflaki and Miles, this volume). During the past two decades, I have devoted considerable attention to observing and understanding the actions of a subset of political entrepreneurs that have come to be called policy entrepreneurs (Mintrom, 1997, 2000; Mintrom and Norman, 2009; Mintrom and Vergari, 1996, 1998). Following Kingdon (1984) and Roberts and King (1996), I have employed the working definition of policy entrepreneurs as political actors who seek policy changes that shift the status quo in given areas of public policy.

This chapter documents how policy entrepreneurs have conducted themselves in the face of intense opposition from groups which disagree with the moral positions embodied in their policy objectives. While the chapter considers instances of policy entrepreneurship in three distinctive jurisdictions, each case involves efforts to secure government funding and permissive regulation of human embryonic stem cell research. Such research promises future therapies that could both extend lives and improve their quality. It also invites serious discussion of the meaning of life (Beckmann, 2004; Hauskeller, 2004; Banchoff, 2005; Fukuyama, 2005; Mintrom, 2009; Karch, 2012).

Human embryonic stem cell research has deep symbolic significance and opens up moral disagreement. Some governments have found effective ways to support this research despite its controversial nature; others have strongly opposed it. Through case studies of policy entrepreneurship and human embryonic stem cell research in California, the United Kingdom, and Italy, the chapter shows how policy entrepreneurs have sought to promote more funding and less restrictive regulation for this controversial area of contemporary science. In each case, the policy entrepreneurs involved met with significant opposition due to the morality issues at stake.

By placing policy entrepreneurship in a broader political context, this chapter makes four contributions. First, it shows how policy entrepreneurs pursue their goals in the face of intense morality politics. Second, it shows how the work of policy entrepreneurs can be both supported and inhibited by ideas, institutions, and interest-groups in the polis. Third, it demonstrates how, by adapting to their contexts and adjusting their strategies, policy entrepreneurs can learn from failures and take new runs at securing policy change. Finally, in making these points, this chapter assists in identifying what makes policy entrepreneurship a distinctive form of political work. Policy entrepreneurship is presented here as a crucial subset of the broader set of activities portrayed throughout this volume as political entrepreneurship.

Aflaki, Inga Narbutaité, and Evangelia Petridou. <i>Entrepreneurship in the Polis : Understanding Political Entrepreneurship</i>, edited by Lee Miles, Taylor & Francis Group, 2015. ProQuest Ebook Central, http://ebookcentral.proquest.com/lib/novasoutheastern/detail.action?docID=1897142. Created from novasoutheastern on 2019-10-01 12:26:00.

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The Work of Policy Entrepreneurs

Among contemporary theories of policy making and policy change, three offer valuable insights into the dynamics of policy change, how the conditions arise that generate change, and the structures of interest groups and other alliances that provide the social capacity for change initiatives. John Kingdon’s (1984) theory of independent streams suggests that policy change occurs in windows of opportunity where specific political events, the current state of the policy conversation among policy elites, and particular pressing problems align in ways that allow for disruptive agenda setting. Frank Baumgartner and Bryan Jones’ (1993) theory of agendas and instability in government combines knowledge of factors that propel major change with Charles Lindblom’s (1959) concept of boundedly-rational actors engaging in incremental change. Baumgartner and Jones argued that patterns of change in most policy domains exhibit “punctuated equilibrium”—that is periods of deep and rapid change that are both preceded and followed by much longer periods of quiet, business-as-usual. Paul Sabatier’s (1988, 1993) theory of advocacy coalitions—the advocacy coalition framework—attends to interactions among diverse stakeholders. Here, the norm-shaping nature of discourse within coalitions over a sustained period of time serves both to generate ideas for policy change and focus the political forces needed to achieve that change. Within all three theories, the role of change agents—or policy entrepreneurs—has been recognized, but it has not been given careful attention.

Close focus on the work of policy entrepreneurs is a recent phenomenon. Michael Mintrom and collaborators have identified the actions taken by policy entrepreneurs (Mintrom and Vergari, 1996, 1998), the ways that contextual factors serve to support or inhibit their actions (Mintrom, 1997, 2000), and the compatibility between these more detailed understandings of the work of policy entrepreneurs and broader theories of policy making (Mintrom and Norman, 2009). Those conceptual and empirical investigations suggest policy entrepreneurs are identifiable not so much by their success in securing policy change but by the actions they take in pursuit of that goal. Policy entrepreneurs tend to work hard at (1) defining and framing problems, (2) building powerful teams that tap relevant knowledge networks, (3) amassing evidence to show the workability of their proposals; and (4) creating strong coalitions of diverse supporters.

Policy entrepreneurs reveal themselves through their efforts to transform policy ideas into actions. By definition, they seek to change status quo policy arrangements. This distinguishes them from many interest group leaders, for whom maintenance of current power relations and institutional settings are accorded highest priority. The focused attention that policy entrepreneurs give to specific issues and their willingness to work effectively with others serve to increase the likelihood that they will secure the policy outcomes they desire. But two points should be kept in mind. First, competency matters and, inevitably, some policy entrepreneurs will be more adept than others at negotiating their operating context. Second, the operating context matters. Just as athletic performance is influenced both by the inherent capabilities of the athlete and the conditions on the day, so too policy outcomes are influenced both by the capabilities of policy entrepreneurs and the broader authorizing context of the polis in which they are operating.

In the case of policy entrepreneurs wishing to change regimes governing controversial science, the broader authorizing environment will be shaped by a number of factors. Regarding human embryonic stem cell research, these factors can include the relative power and ascendancy of specific interest groups, such as the Catholic Church or the local science and innovation community. Their context can also be crucially shaped by the composition of elected officials in the legislature and relations between those officials and other powerful decision makers (such as presidents or the judiciary). These contextual influences on the effectiveness of policy

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entrepreneurs have been discussed in detail by Michael Mintrom (2000). Differences in contextual factors can significantly influence the time needed for policy entrepreneurs to achieve desired policy outcomes. In turn, they can affect the nature of the work they do in the development and coordination of advocacy coalitions. Jocelyn Crowley (2003, 2008) has documented examples of policy entrepreneurship and advocacy efforts spanning several decades. Later in this chapter, case studies highlight the relationship between the work of policy entrepreneurs and the broader authorizing environment, with reference to advocacy for more permissive governance of human embryonic stem cell research.

Human Embryonic Stem Cell Research

Stem cell research need not necessarily be controversial. Although all cells within an organism contain the same genetic information, as they develop they become specialized, which allows them to carry out very different and specific functions throughout the body. In contrast to specialized cells, stem cells are uncommitted cells serving no specific purpose. They remain uncommitted until they receive signals to develop into specialized cells. Scientists have speculated about stem cells and their qualities for over a century (Ramalho-Santos and Willenbring, 2007). The existence of stem cells was discovered mainly through investigations into animals, particularly mice. Stem cells are known to exist in both adults and embryos, and stem cell researchers have studied the behavior of both adult stem cells and embryonic stem cells. However, questions remain concerning the plasticity of non-embryonic stem cells—that is, their ability to transform into a variety of specialized cells (National Institutes of Health, 2006).

In 1981, researchers from Cambridge University in the United Kingdom reported methods for growing mouse embryonic stem cells (Evans and Kaufman, 1981). In 1998, James Thomson and his team of researchers from the University of Wisconsin-Madison reported the isolation of human embryonic stem cells (Thomson et al., 1998). Embryonic stem cells are derived from cells called “the inner cell mass”, which is part of several-day-old embryos, or blastocysts. If left in the right environment, these cells would develop into an embryo. Once removed from the blastocyst, the cells of the inner cell mass can be cultured into embryonic stem cells. These embryonic stem cells are not themselves embryos and evidence has shown that these cells do not behave in the laboratory as they would in the developing embryo. After researchers have isolated stem cells from a human embryo, the cells can often replicate indefinitely if kept in the correct environment. This creates what is termed a “cell line.”

The ability of the Wisconsin team to isolate human embryonic stem cells and cultivate stem cell lines was a significant scientific breakthrough. Evidence subsequently emerged that these cells are capable of becoming almost all of the specialized cells of the body and may have the potential to generate replacement cells for a large number of tissues and organs, such as the heart, the pancreas, and the nervous system. Because of this, stem cells are seen as having several important scientific and medical applications. These include being used for repair or replacement of cells or tissues that are damaged or destroyed by a variety of diseases and disabilities, testing new drugs in a controlled and safe setting, and studying genetic function and development processes (National Institutes of Health, 2001).

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Morality Politics Associated with Human Embryonic Stem Cell Research

Proponents of human embryonic stem cell research have pointed out that in the natural reproductive process, human eggs are often fertilized but fail to implant in the uterus. A fertilized egg, they argue, while it may have the potential for human life, cannot be considered equivalent to a human being until it has at least been successfully implanted in a woman’s uterus (American Association for the Advancement of Science, 2007).

While some have considered embryonic stem cell research to be justifiable for the advancement of scientific knowledge, they have worried greatly about the future (Fukuyama, 2005). Looking ahead, the possibility arises of extensive growth in markets for the trading of human eggs. This would create incentives for women to produce and sell eggs that would then be fertilized to create embryos solely for the purpose of destroying them at the blastocyst stage to harvest the stem cells. As is, trading of human eggs has become common in response to the demands of infertile couples to gain access to donor eggs for making babies (Withrow, 2007). Scientists seeking to work with human embryos for stem cell research obtain human eggs from in vitro fertilization clinics. In the process of treating infertility, more eggs are produced than are used for the purposes of creating viable embryos. Surplus eggs can be stored, discarded, or donated to research (Trivedi, 2007). Proponents of embryonic stem cell research have held that it is morally permissible to use surplus embryos for potentially life-saving biomedical research. Opponents have objected to this argument, however, saying that such research would still condone the destruction of embryos.

Some stem cell research is non-controversial. This includes stem cell research using animals and research using cells derived from human placentas discarded at birth or tissue from adult human skin cells. Indeed, work by James Thomson and his Wisconsin team announced in 2007 could eventually take much of the heat away from the controversy over embryonic stem cell research. That is because Thomson’s team discovered how to use genetic modification to reprogram non-embryonic human cells so that they exhibit the essential characteristics of embryonic stem cells (Yu et al., 2007). This work holds promise because it allows for the possibility of using a patient’s own skin cells to create genetically-matched stem cells that could be used to make replacement cells and tissues for that patient, without the risk of rejection by the immune system. However, questions remain about the distinction between embryonic stem cells and stem cells derived through genetic modification, making on-going work with human embryonic stem cells crucial to the advancement of this scientific work (Kolata, 2007).

Issues surrounding human cloning also arise in the management of human embryos and the harvesting of embryonic stem cells. That is because the only technique known so far for growing stem cells genetically matched to a subject has involved injecting cells from that subject into a human egg to clone that person and then extract the embryonic stem cells from the blastocyst. Such a procedure and the moral issues associated with it could also be rendered redundant through the research into reprogramming of non-embryonic human cells into stem cells. However, the issue of cloning has created another point of deep controversy surrounding this research (Fukuyama, 2005).

The Geography of Human Embryonic Stem Cell Research

Publication of original research articles exploring aspects of stem cell science have routinely appeared in two of the world’s leading scientific publications: Science and Nature. Since 2007, another top scientific journal, Cell, has published articles on stem cell research in Cell Stem Cell. Following Mintrom and Bollard (2009), a place-of-origin analysis was performed on articles

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published in those journals in the period from January 1998 through December 2011. This analysis counted original research publications where the term “stem cell” appeared in either the title or the abstract. Across the three journals during this period, lead authorship of articles was attributed to scientists located in 24 countries. Of those countries, 20 were members of the OECD and 16 were home of at least one university ranked as being among the world’s top 100 in the Academic Ranking of World Universities, 2011. Additionally, almost perfect correlations existed between the proportions of publications by place-of-origin across the three journals.

In all three journals, well over half of the publications were based on science conducted in the United States. Within the United States, scientists based in California took the lead in publishing in these journals. The second-most common country of origin was Japan. Among European countries, scientists from the United Kingdom led the publication count. Publications from other European countries were sporadic. This pattern indicates that the primary predictor of a country hosting stem cell research is not the religious mix of the population but the wealth of the country and the commitments that successive governments have made to the funding of their research universities. Among countries hosting universities ranked in the world’s top 100 in 2012, the United States hosted 54. Of those 54, 11 were located in California. No other state in the union exhibited such a concentration of top-ranked universities. The United Kingdom hosted 11 universities in the world’s top 100. This analysis suggests that, in some jurisdictions, the public debates over stem cell research represent little more than political and moral posturing because general, long-term government commitment to funding of premier scientific facilities (for any kind of science) has been lacking.

Policy Entrepreneurs and Human Embryonic Stem Cell Research

Studies of policy entrepreneurship have flourished in the past three decades (Mintrom and Norman, 2009). Following John Kingdon’s (1984) path-breaking discussion of what policy entrepreneurs do, research on the activities of policy entrepreneurs has tended to employ case-study techniques. There have been exceptions. For example, Mintrom (1997, 2000) used event history analysis to quantitatively test the impact of policy entrepreneurs and various contextual conditions on legislative agenda setting and policy change. However, to achieve adequate control of other explanations of policy change, quantitative investigations of policy entrepreneurship require high levels of institutional isomorphism across the jurisdictions included in the study. Such isomorphism is present in many federalism systems but is rarely found across independent countries. A major challenge for policy researchers lies in establishing tractable ways to conduct cross-national studies of policy entrepreneurship.

For the research reported here, the motivating question was: How have policy entrepreneurs shaped the governance of human embryonic stem cell research? The geography of stem cell research served to limit the set of countries relevant to the study. To date, scientists based in just 11 European countries have published the results of stem cell research in Science, Nature, or Cell Stem Cell. Those countries are: Austria, Belgium, Denmark, France, Germany, Italy, the Netherlands, Spain, Sweden, Switzerland, and the United Kingdom. Since the research reported here was exploratory in nature, the “diverse case” selection approach (Gerring, 2007) was followed. Three jurisdictions were selected as cases, each offering distinctive contexts with respect to the generation of human embryonic stem cell research and the broader political environment. The jurisdictions were: California, the United Kingdom, and Italy. In each case, enough documented evidence was available to assist in the interpretation of the role that policy entrepreneurs have

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played in seeking government funding and a favorable regulatory regime from human embryonic stem cell research. In the following case studies, attention is paid to how advocates of stem cell research have sought to (1) define and frame problems, (2) build teams tapping relevant knowledge networks, (3) amass evidence to show the workability of their proposals; and (4) create strong coalitions of diverse supporters.

California

In California, efforts to fund, oversee, and regulate human stem cell research have occurred within the context of actions taken by the United States Government. After the announcement in 1998 that James Thomson and his team at the University of Wisconsin had isolated human stems cells and created stem cell lines, the question arose as to whether federal funds could be used to support research on human embryonic stem cells. In 2001, United States President George W. Bush deemed that federal funds would support research only on stem cell lines derived prior to August, 2001.

In 2002, California became the first state in the United States to pass legislation that explicitly allowed stem cell research involving both the destruction and donation of human embryos. The bill was intended to bolster the attractiveness of California as a location for stem cell researchers. No new funding was associated with passage of this law. It required that research involving the derivation and use of human embryonic stem cells, human embryonic germ cells, and human adult stem cells be reviewed by an approved institutional review board. This law also facilitated the voluntary donation of embryos for stem cell research. It required that individuals receiving infertility treatments be provided information regarding the disposal of an embryo, including the possibility of donating embryos for research. It prohibited the sale of embryos.

The subsequent political action that opened up major funding streams for stem cell research in California revolved around the drafting and approval of a citizen proposition, Proposition 71, the California Stem Cell Research and Cures Act of 2004. The Proposition was designed to amend the state constitution to further facilitate embryonic stem cell research. The proposition also established the California Institute for Regenerative Medicine (CIRM)—the state stem cell agency—and authorized a bond sale to allow around $300 million per year for embryonic stem cell research over a ten-year period. That level of expenditure represented significantly more than what the federal government was committing to stem cell research at the time. Indeed, it exceeded the funding for this research provided by any other jurisdiction in the world.

The move to secure extensive state support for stem cell research in California was spearheaded by Bob Klein. Klein, a multi-millionaire and graduate of the Stanford Law School at Stanford University, made his fortune through the development of state-funded low-income housing in California. During his career, he gained extensive experience engaging in quiet efforts to secure political support for property development activities. Significantly, one of Bob Klein’s sons suffers from autoimmune-mediated (type 1) diabetes. Klein noted this as a primary motivator for his advocacy of stem cell research.

With respect to (1) defining and framing the issue, in developing and promoting Proposition 71, Bob Klein took great care to emphasize the creation of cures for degenerative diseases. Thus, the proposition was named “the California Stem Cell Research and Cures Act.” In terms of (2) building a powerful team, Bob Klein worked closely with venture capitalists, leaders of biotechnology firms, and representatives of the state’s strong scientific and medical research communities while drafting the proposition. Universities in the state stood to gain from the initiative, and they assisted in development of the proposition. In terms of showing the workability of the proposal (3), significant efforts were made to learn from past experience, and to build legislation that would

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enable development of stem cell research in California. The proposition bypassed the legislative process and secured direct public support. This eliminated the need for compromise in the enacting legislation. It funded stem cell research through state bond issues, rather than through the general revenue fund. This protected the stem cell funding from subsequent cutbacks due to fiscal constraint. It created large-scale funding of research, which in the United States is normally done by the federal government. The governance and oversight arrangements for the distribution of the funds followed models like those used by the United States National Institutes of Health and the National Science Foundation. By involving an amendment to the California Constitution, the proposition made the conducting of stem cell research a constitutional right, one that could not be easily overruled by the legislature. Finally, in terms of creating a strong coalition of diverse supporters (4), Klein chaired the “Yes on 71” campaign. Throughout the campaign, Klein made powerful arguments to state political leaders and citizens alike that funding for stem cell research promised major pay-offs for California. These pay-offs were presented as the saving of lives through scientific advancement and the securing of greater economic prosperity through the expansion of high-technology industries.

California’s Proposition 71 passed with support from a strong majority of voters. Klein subsequently served as chair of the Independent Citizens Oversight Committee (ICOC) that governs the California Institute for Regenerative Medicine (CIRM), the state’s stem cell research funding agency. It is important to note that Proposition 71 and the subsequent efforts to establish the funding agency met considerable opposition. Citizen groups in California—especially those organized on the basis of religious affiliation or specific disabilities—questioned the ethics of this research and the merits of directing funds into scientific work rather the alleviation of suffering using current medical practices. In addition, opponents of the proposition, led by conservative Christian groups, initiated a series of lawsuits that hindered the ability of CIRM to be funded from bond issues. Until 2007, the Institute and its programs were funded through the state budget and private donations.

The United Kingdom

In the United Kingdom, a permissive approach has been taken to the funding and regulation of human embryonic stem cell research (Hauskeller, 2004). While human reproductive cloning is banned, the current regime permits the creation of embryos for research purposes as well as for the derivation of stem cell lines and for cloning for research purposes. This permissiveness, and the existence of a long-established, well-supported scientific community has allowed the United Kingdom to stand as a leading jurisdiction for the advancement of human embryonic stem cell research. A permissive environment has also suited industrial interests who have recognized the extensive commercial possibilities associated with developing medical therapies based upon stem cell research (Hauskeller, 2004; Franklin, 2006; Schechter, 2010). To the extent that policy entrepreneurship has occurred in this context, it has been undertaken quietly and within an institutional context that has facilitated huge expansion in human embryonic stem cell research. Moral issues have been widely canvassed, and heated debates have occurred but they have not inhibited scientific research. Given this context, it is impossible to identify one specific individual as a policy entrepreneur. Rather, there have been “entrepreneurial moments,” where particular individuals have played decisive roles and have taken actions. Those individuals include Mary Warnock and Ruth Deech.

Relevant history relating to research on embryos in the United Kingdom dates back to the early 1980s, and what Michael Mulkay (1993) has termed the “Great Embryo Debate.” In Vitro Fertilization was producing surplus embryos that were readily accessible material for research. This

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led to concern over the status of embryos. The medical community, which claimed more research would support better treatment, was opposed by critical voices in public and in Parliament. In 1982, the British Government established the Committee of Inquiry into Human Fertilization and Embryology, chaired by Mary Warnock, a philosopher. In what now appears as a significant act of policy entrepreneurship, Warnock (1985) and her colleagues recommended that a government agency be established to regulate artificial fertility methods as well as embryonic research. At the outset, Warnock’s report upset both scientists—who resisted strict regulation of their work— and religious groups—who wished to protect human embryos. However, following much debate, Warnock’s basic proposal was adopted into law. In 1990, the Human Fertilization and Embryology Authority (HFEA) was established, responsible for all issues concerning human fertility and for research with human embryos. The new law resolved prior debate by acknowledging that the moral status of the human embryo is different from any other research object. However, a governing principle was established that the moral value accorded to human embryos may be outweighed by other serious moral considerations (Hauskeller, 2004).

When stem cell research became a reality by the end of 1998, embryo research was already a regulated but normal practice in the United Kingdom. The established procedures of the Human Fertilization and Embryology Authority created space for careful discussion of newly arising issues in the field. According to Christine Hauskeller, “the procedures and practical questions of directing such research to be successful and effective as possible in favour of new therapies was prefigured both in the prevailing structure of ethical reasoning and the resulting institutions” (2004, p. 515). From the beginning, the Human Fertilization and Embryology Authority promoted human embryonic stem cell research. During the period from 1994–2002, the Authority was chaired by Ruth Deech, now Baroness Deech, who subsequently co-authored a book on the Authority’s work (see Deech and Smajdor, 2007). Deech led the Authority in a manner that created more opportunities for human embryonic stem cell research to be conducted in the United Kingdom. HFEA Members are appointed by UK Health Ministers. The Members determine the HFEA’s policies. In order that a perspective can be maintained which is independent of the medical-scientific view, the enabling legislation (Human Fertilization and Embryology Act, 1990) requires that the Chairman, Deputy Chairman, and at least half of the HFEA’s Membership be neither doctors nor scientists involved in human embryo research. Members are not appointed as representatives of different groups, but bring to the HFEA a broad range of expertise.

As chair of the Human Fertilization and Embryology Authority, Ruth Deech performed many functions consistent with being a policy entrepreneur. In her role, she had the resources and the stature to work with others to (1) define and frame policy discussions. Through the Authority’s links to the scientific and policy communities, Deech was (2) able to assemble ad hoc teams to explore emerging policy issues. Deech and her colleagues at the Authority continually (3) amassed evidence to show the workability of its proposals. Indeed, they took care to be transparent about the scientific work they authorized. As such, Deech established for herself a powerful position for leading policy debate and (4) gained the support of strong, diverse coalitions.1

The quiet, agenda-setting actions of Ruth Deech and the Human Fertilization and Embryology Authority in the United Kingdom are illustrated by the process that led to adoption of the Human Fertilization and Embryology (Research Purposes) Regulations 2001. In 1998, the Authority, in collaboration with the Human Genetics Advisory Commission, established a Working Group chaired by the Reverend Dr. John Polkinghorne, a former professor of mathematical physics at Cambridge University, who had subsequently become an Anglican priest. That choice of chair

1 The author is grateful to Baroness Deech for verifying this interpretation of her activities at the HFEA. Aflaki, Inga Narbutaité, and Evangelia Petridou. <i>Entrepreneurship in the Polis : Understanding Political Entrepreneurship</i>, edited by Lee Miles, Taylor & Francis Group, 2015. ProQuest Ebook Central, http://ebookcentral.proquest.com/lib/novasoutheastern/detail.action?docID=1897142. Created from novasoutheastern on 2019-10-01 12:26:00.

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illustrates how Deech and her colleagues sought to appear even-handed in its consideration of issues. In 1998 the Working Group produced a paper, “Cloning Issues in Reproduction, Science and Medicine” (Human Genetics Advisory Commission and The Human Fertilization and Embryology Authority, 1998). It argued that research using cell nuclear replacement (in which the nucleus of an adult cell is fused with an egg which has had its nucleus removed) could lead to new treatments for serious disorders by providing a source of new tissue. In response, in June 1999, the Government announced the establishment of an Expert Group chaired by the Chief Medical Officer, Professor Liam Donaldson, to advise on whether new areas of research that could lead to broader understanding of, and eventually to new treatments for, a range of disorders where there is disease or damage to tissues or organs using embryos should be permitted. Notably, Donaldson’s Expert Group was not asked to review from first principles the ethical issues of research involving embryos. Rather, it was asked to consider only new ethical issues that might arise from the creation and use of embryos for the extraction of stem cells.

The Donaldson Report was released in August 2000 (Department of Health, 2000). It proposed the legalization of research with stem cells derived from embryos within 14 days of fertilization. Such research, it contended, should be subject to rigorous scientific and ethical review and it should be conducted primarily with stem cells derived from embryos left over from in vitro fertilization treatments. Following the advice initially promulgated by the Human Fertilization and Embryology Authority’s Working Group, Donaldson and his colleagues proposed that the creation and cloning of embryos for biomedical research be allowed. New legislation consistent with this was adopted in December 2000.

The period from August to December of 2000 witnessed considerable debate. While it was initiated by actions of the Human Fertilization and Embryology Authority, the agency itself remained silent through this period. Statements in support of cloning for research purposes were provided from many quarters, including the Medical Research Council, the Welcome Trust, the Nuffield Council on Bioethics, the British Medical Association, and the Royal Society. Patients’ groups, such as the UK Parkinson’s Disease Society, also backed the law change. American former actor Christopher Reeve joined the campaign, and Colin Blakemore of the Medical Research Council described his role as “very significant” (Gottweis and Prainsack, 2006). While scientists, Professor Donaldson, and Members of Parliament aligned with the governing Labour Party were most prominent in supporting the law change, Conservative Members of Parliament, religious figures, and pro-life groups were among its most vocal opponents (Williams, Kitzinger, and Henderson, 2003). This successful action to promote stem cell research in the United Kingdom illustrates how effective policy entrepreneurship can set the terms for subsequent debate. It also illustrates how long-established institutions and the power of entrenched interest groups can assist those promoting policy changes fraught with moral issues.

Italy

In Italy, a virtual ban has existed on human embryonic stem cell research since 2004. This ban is a by-product of an effort to protect and afford citizenship to the embryo from the moment of conception. The Italian Medical Assisted Procreation Law No. 40 of 2004 stipulates that clinical and experimental research on a human embryo can be conducted only for therapeutic or diagnostic purposes which are exclusively directed to the protection of the embryo’s health and development. In vitro fertilization is allowed, but no surplus embryos are to be produced. Since this law is solely focused on the human status of the embryo, Italian scientists are free to work on stem cell lines derived from human embryos, so long as they are imported as human stem cell lines, once created,

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and exist outside of the embryo. However, this kind of research is difficult to sustain in Italy because national funding for stem cell research is restricted to work using stem cells derived from adult tissues, from cord blood, and from aborted foetuses. The Roman Catholic Church has been active in efforts to restrict research on human embryonic stem cells (Metzler, 2007) and, in 2006, Cardinal Alfonso Lopez Trujillo expressed his view that excommunication from the Church was merited for researchers who destroyed human embryos (Rosenthal, 2006).

The Italian case highlights two conditions that restrict efforts to advance human embryonic stem cell research. First, the Roman Catholic Church—a historically powerful institution in Italian society—has maintained a strong moral stance that accords the human embryo full status as a human being. So morality politics have played against policy entrepreneurs seeking support for human embryonic stem cell research. Second, the limited nature of the funding available to Italian scientists in this field has inhibited the development of institutional support for human embryonic stem cell research. Only when communities of scientists achieve a critical mass do we tend to see their work receive support from entities such as universities, scientific associations, and businesses that perceive commercialization potential in the research.

In the face of difficult circumstances, policy entrepreneurs have sought to advance the place of human embryonic stem cell research in Italy. Those policy entrepreneurs comprise a team of scientists lead by Professor Elena Cattaneo, Director of the Center for Stem Cell Research (UniStem) at Università di Milano. Cattaneo has published in Science and Nature on matters relating to neural stem cells and Huntington’s Disease.

To date, the actions of the Italian policy entrepreneurs have not provoked policy change. However, their actions are consistent with efforts of policy entrepreneurs elsewhere to (1) define and frame problems, (2) built teams tapping relevant knowledge networks, (3) amass evidence to show the workability of their proposals; and (4) create strong coalitions of diverse supporters.

With respect to (1) defining and framing problems, in 2007, Cattaneo’s group known as the Italian Researchers on Embryonic Stem Cells (IES Group) produced its “Manifesto for Scientific Research on Embryonic Stem Cells.” In response to powerful opposition from those who wish to protect the life of human embryos, the signatories to the Manifesto stated: “we hold there is a moral duty to pursue … research on embryonic stem cells [because it] is an essential step towards understanding how human tissues are generated and become diseased. In our view, the gaining of this knowledge per se is already ethically sound and sufficient to justify protecting the freedom of scientific research, which is also consistent with [Italy’s] Constitution.” They also wrote: “We maintain that embryonic stem cell research is ethically sound and necessary, in particular when performed with cells that are already available, and otherwise destined to be destroyed or wasted” (Italian Researchers on Embryonic Stem Cells Group, 2007, pp. 1–2). The Italian researchers have also built teams tapping relevant knowledge networks. It is clear from documents associated with their advocacy work that they have gained insights from lobbying practices in other countries (see, e.g., Cattaneo and Corbellini, 2010).

With respect to (3) amassing evidence of the workability of their proposals, Cattaneo and her colleagues have run a series of annual conferences in Italy to bring stem cell researchers together and to showcase for the public the potential benefits of their work with human embryonic stem cells. The creativity of the group has also been evident in their efforts to (4) create strong coalitions of diverse supporters. They have targeted young people to educate them in the nature of stem cell research and its potential social benefits. Along with holding public lectures, and days dedicated to high school students, they have been experimenting with social media and collaborating with theater groups and film makers to get their message across in innovative ways. In March 2012 more than 9,000 students from 160 high schools in 20 cities throughout Italy got together with stem cell

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researchers to participate in UniStem Day 2012. This was the largest dissemination initiative about stem cells ever held in Italy. Activities on offer included lessons and meetings with researchers, visits to laboratories, games, videos, dance, and music. Here we see dedicated scientists battling against powerful opposing forces through creative political activities intended to bring new groups into the discussion and, hence, shift the locus of power in the public debate.

Conclusion: Learning from Failure and Success

The functions and activities of policy entrepreneurs take place within broader contexts that have been effectively theorized through notions of punctuated equilibrium (Baumgartner and Jones, 1993), windows of opportunity (Kingdon, 1984), and advocacy coalitions (Sabatier, 1988). By deepening our knowledge of these policy actors who have too often appeared “ghost like” in the policy literature, we also deepen our knowledge of the applicability of specific policy frameworks to the interpretation of diverse instances of agenda setting and policy change. This chapter has examined instances of policy entrepreneurship in the pursuit of government funding and favorable regulation to advance human embryonic stem cell research in California, the United Kingdom, and Italy. The concept of the policy entrepreneur offers illumination into the governance of human embryonic stem cell research, and cross-jurisdictional differences in governance arrangements. However, all forms of policy entrepreneurship take place in contexts that can have significant implications for the effectiveness of advocacy efforts.

The policy entrepreneurship highlighted here has been more effective in California and the United Kingdom, where there has been a general, long-term government commitment to funding of premier scientific facilities. It should not be a surprise that the most productive scientists working on human embryonic stem cells are located in these jurisdictions, with their unusually strong concentrations of universities ranked among the world’s top 100. The well-established and well-supported scientific communities in these jurisdictions appear to have served as strong countervailing forces for religious groups and others who, on moral grounds, have opposed research on human embryonic stem cells. Nonetheless, the morality politics surrounding this science have been significant everywhere, and they have influenced governance arrangements.

In California, the drying up of federal funding for human embryonic stem cell research provided a strong impetus for efforts to secure state-level funding. Choosing to secure a favorable funding and regulatory environment through direct democracy—the use of Proposition 71 proved an effective means of avoiding common pitfalls of legislative politics. The wording of the Proposition was highly detailed, and indicated a high degree of political savvy on the part of Bob Klein and his many institutional backers. What was portrayed in the media as the crusade of a concerned father was, in fact, a highly coordinated effort by a powerful advocacy coalition to make effective use of a window of opportunity. In the face of an impasse at the federal level, a chance arose for California to consolidate its place nationally and internationally as a leader in the support of human embryonic stem cell research.

In the United Kingdom, a period of intense policy change occurred in the 1990s and early 2000s. This period punctuated the longer period of policy equilibrium preceding it, and set the direction for future incremental policy changes. The work of policy entrepreneurs was crucial to achieving the major shift in the governance of human embryonic stem cell research in that country. Today, ethical questions are subordinate to medical and commercial argumentation. In contrast, the Italian case illustrates the enormity of the agenda setting task confronting those who wish to challenge an entrenched status quo enjoying support from well-established and powerful interest

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groups. In such instances, efforts to create new advocacy coalitions appear the most effective course of action. However, such work takes concerted effort over an extended period of time. The focus of Italian policy entrepreneurs on educating young people about human stem cell research indicates their acute awareness of the need to engage in efforts targeted at long-term social and ideational change. In that instance, the focus of the policy entrepreneurship has been on coalition building, rather than tactical efforts to secure immediate change.

The evidence of policy entrepreneurship in support of human embryonic stem cell research suggests six lessons about failure and success.

1. Policy entrepreneurship is a team sport. The strength and diversity of their supporting advocacy coalitions is vital to the success of particular policy entrepreneurs. This was noted in all three cases here: California, the United Kingdom, and Italy.

2. Policy entrepreneurship can require the construction of new coalitions, and the careful recruitment of allies. The pursuit of new policies can often involve engaging in new kinds of political strategy. Again, this was noted in all three cases in this chapter.

3. Policy entrepreneurship involves learning on the job. Barriers to success, and failed attempts to secure policy change, while deeply frustrating, always present learning opportunities. Difficulties often make policy entrepreneurs more savvy and strategic. This has certainly been the case in California and Italy, where initial failures led to major changes in political strategies of the respective policy entrepreneurs.

4. Policy entrepreneurship tends to be most effective when people with “insider” knowledge of bureaucratic and legislative conventions combine their efforts with “outsiders” who can effectively work with a range of people representing different interests and preoccupations. This is demonstrated in this chapter most clearly by the case of the United Kingdom.

5. Policy entrepreneurship requires patience. Efforts to secure desired policy change usually take many years. A great deal of preparatory and planning work must occur before success comes. The cases of California and the United Kingdom demonstrate this. It is clear that the press for more openness to funding stem cell research will take a very long time in Italy.

6. Policy entrepreneurship is compatible with incremental change. Unless unusual mechanisms for change exist, such as the ballot in California, significant, dynamic policy change can be difficult to secure in one hit. However, effective strategic planning can ensure a series of incremental improvements over a period of time add up to major change. That has certainly been the case in the United Kingdom. Interestingly, the speed of the incremental change can increase with time. As the impacts of small victories start having collective effect, they can establish platforms from which further changes can be readily accomplished. Indeed, coordinated, strategic pursuit of incremental change may result in the attainment of major changes that—had they been introduced all at once—would have met with significant political resistance.

While the focus of this chapter has been on policy entrepreneurship and a specific scientific agenda, the findings hold implications for those studying the dynamics of change across many substantive areas of public policy. Here, we have gained more clarity around the ways that policy entrepreneurs can pursue their goals in the face of intense moral debates. We have also gained greater awareness of how the work of policy entrepreneurs can be both supported and inhibited by ideas, institutions, and interest-group politics. The evidence is accumulating to show how political entrepreneurship has been pursued in many different contexts. As the study of political entrepreneurship expands and deepens, it is clear that the study of policy entrepreneurship will remain central to the research agenda.

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