Comparative Biomedical Policy

Governing Assisted Reproductive Technologies

Ivar A. Bleiklie, Malcolm L. Goggin, Christine Rothmayr

• Publisher: Routledge
• Year: 2004
• eBook ISBN:
  9781134342549
• Print ISBN:
  9780415325479
• Subtopic: Medical Law

This book presents a comparative study examining assisted reproductive technology policies in North America and Europe. Based on original and detailed research, this up-to-date volume establishes a knowledge base for understanding policy debates on topics such as embryonic stem cell research and therapeutic cloning.

1 The Comparative Policy Design Perspective

Malcolm L. Goggin Deborah A. Orth Ivar Bleiklie and Christine Rothmayr

Six years ago, the editors of and many of the contributors to this volume met at a policy workshop of the European Consortium for Political and Social Research (ECPR) in Bern, Switzerland. As the meeting came to a close, workshop participants decided to organize a collaborative cross-national research project focusing on policy design and re-design. This book is the product of that six-year collaboration, called the Comparative Policy Design Project, or CPDP. Here we report research findings from this comparative study of how our first chosen field – assisted reproductive technology (ART) policies – is governed in nine European and two North American countries.

Comparative Biomedical Policy: governing assisted reproductive technologies is the result of six years of systematic theory-driven empirical research undertaken by a team of thirteen scholars. Herein we report the results of a comprehensive cross-national analysis of a field that has become an important policy issue. As we enter the twenty-first century, almost twenty-five years after the birth of Louise Brown, the first baby born from in vitro fertilization, countries across Europe and North American have adopted very different policy designs for governing ART. One goal of analysing and comparing the adopted policy designs is to establish a knowledge base for understanding current high profile policy debates such as the current discussion of embryonic stem cell research and human and therapeutic cloning in North America and Europe.

Comparative Biomedical Policy has two other purposes. One is to use our analytical framework as a guide to understanding design and re-design in the ART policy domain. ART is a relatively young policy area with an identifiable starting point in the 1970s. Furthermore, there is considerable variation in ART policy design across the eleven countries included in this comparative study. Thus it provides an ideal vantage point for dealing in a systematic comparative way with basic questions in policy research, such as:

• How are new policies made?
• To what extent are policies framed and defined by established institutions and policies?
• To what extent are policies the outcome of identifiable actor strategies and choices?
• To what extent do specific new policy areas, like ART, have characteristics that make them special?

The fact that ART is a new field makes the application of existing assumptions and theories about policy design particularly interesting and fruitful for future studies of policies dealing with biomedicine. We argue that even though we are dealing with a new and emerging policy field with unique characteristics, such as a high rate of scientific innovation, and touching upon fundamental ethical questions about human life, we expect the application of existing assumptions from the field of policy design to contribute to explaining and understanding current policy choices.

The comparative analysis of policy design and re-design in advanced industrial democracies also allows us to contribute to theory development, the third purpose of this collaborative project. We have limited our study to advanced Western industrialized democracies in order to have comparable cases with respect to, first, the level of technological development in biomedicine, and second, the dominant Christian religious tradition as a general context variable.

In this introductory chapter, we briefly describe the field of Assisted Reproductive Technology and discuss why it is an important policy domain for comparative study. Then we present the analytical framework and the data collection and measurement strategies that guide our comparative case study research. We believe that what makes this collection of original essays by country specialists unique is that it represents a carefully designed and centrally coordinated and controlled programme of research. All the original essays in this proposed book use a common analytical framework; the coding and survey instruments used to collect data in all eleven case studies are identical. Finally, we sketch out the book’s organization.

What is ART and why is it an Important Policy Domain?

The last decades have witnessed rapid developments in biomedicine, in particular in the fields of reproductive technologies, genetic screening, genetic engineering and organ transplantation. Despite the considerable amount of political activity and the public attention surrounding these biomedical issues, there is little political science research on this topic. As Blank and Hines (2001: 107) observe:

There is already a fairly well-developed debate over biopolicy issues, and political scientists, those supposedly trained to deal with such concerns, are largely absent. Resolving these issues requires sensitivity to the political dimension. The literature is rife with confusion, often consciously imposed, over what is meant by government intervention, what the policy process is and how the political system works.

This absence of empirical political research on biomedicine is particularly evident if we compare the body of literature in the growing fields of bioethics, biolaw and bioeconomics (Blank and Hines 2001: 10–11; Roth-mayr and Varone 2002).

In our research, we focus on one domain within the biomedical field, assisted reproductive technology. Assisted reproductive technologies are defined as those techniques where egg and sperm are not brought together (or an embryo is not created) through sexual intercourse, but rather through medical intervention; ART also includes research and social issues related to the application of these techniques.¹ Currently, human cloning and stem cell research are notoriously at the centre stage of public controversy and political regulation. In all the countries studied in this volume, this is not the first time that medical practice and research in ART have led to public debate, however. The invention of the technique of in vitro fertilization (IVF),² i.e. fertilization outside the women’s body ‘in a glass’ (in vitro), in the late 1970s and its routinization in the mid-1980s elevated the issue of ART on the global political agenda. In vitro fertilization also created the basis for new practices in ART³ as well as for new research related to reproductive technologies, such as embryonic stem cell research and cloning. Other techniques, namely insemination⁴ by donor, have been practised since the 1960s without leading to larger debates.

Empirically we delimited our field of analysis by defining a number of techniques and issues to be included. We studied all policies addressing what we labelled basic techniques, consisting of artificial insemination (AI), in vitro fertilization (IVF) and Gamete Intrafallopian Transfer (GIFT).⁵ Then we included some issues and techniques related to these basic techniques: surrogacy arrangements,⁶ and the issues of donation (sperm, egg, embryo), cryopreservation, gender selection,⁷ genetic selection, preimplantation diagnostics⁸ and ICSI. Finally, we looked at what we labelled research and experimental techniques, including genetic engineering (on gametes and embryos), embryo research, cloning (reproductive and therapeutic) and chimera and hybrid building.⁹

The ART policy field is important for a number of reasons. By choosing ART we have deliberately avoided the traditional sector-oriented comparisons. Instead, we have selected a policy domain that is under-studied as well as politically salient, controversial, involves issues that involve strong beliefs and moral convictions, and engages experts who often play a crucial part in the policy designing process. ART is part of a growing number of issues, dealing with fast-changing technology, which raise basic ethical questions about the engineering of human life. The ART policy domain allows us, therefore, to focus on questions regarding policy implications of the interaction of advanced technology, ethics and democratic policy-making. The ART domain not only raises the question of whether and how to regulate science and technology, but also raises health policy issues such as quality and safety of treatment, patient informed consent and child well-being, to name a few examples.

The medical sector has a particularly strong tradition of professional autonomy and self-regulation (Hassenteufel 1997). Professional autonomy means that physicians self-regulate their profession in order to guarantee quality of treatment and respect of ethical standards. Self-regulation might therefore be understood as the control over knowledge, which can be structured along three arenas of activity: creation (research), transmission (teaching) and application (performance) (Salter 2001: 872). In the field of ART, two arenas of activity were at centre stage in the debates on ART: research, or the creation of knowledge and technology, and the application of the new techniques. Strong beliefs and moral convictions regarding the science and technology of ART have led some to question the merits of expert autonomy and self-regulation (Hassenteufel 1997: 203–60; Salter 2001: 872).¹⁰ Indeed, one might wonder to what extent ART policy affects the autonomy of the medical profession.

Autonomy

By autonomy we mean the amount of freedom that doctors and researchers as the main target groups for ART policy enjoy, either to practise ART or to conduct related research, respectively. In practical terms, autonomy refers to a physician’s freedom to decide matters such as what ART to practise and how to practise, who can practise ART, and how compliance with practice guidelines is assured. Autonomy also refers to a researcher’s freedom to decide what type of research to conduct, how to conduct it, who can and cannot conduct research, where to publish findings, and how to secure quality of research. Finally, there is the question of the extent to which researchers and practitioners act as implementers of policy, and how much autonomy they enjoy in their role as implementer.

Access

Physicians and researchers are not the only target groups ART policies are addressing. There are also infertile couples and anyone who might want to make use of ART to have offspring – i.e. the ‘clients’. Access refers to the extent to which potential users of ART may avail themselves of such technologies. Currently, these users are mainly seeking to produce children. However, as technologies develop other users (for example, those suffering from diabetes or Parkinson’s disease) may seek therapies derived from embryonic stem cells. Policies may also regulate access by defining eligibility criteria – for example, age, marital status or sexual orientation – used to approve the application of the person seeking infertility treatment. Access is also a function of the amount of private or public insurance or funding that is provided to users for ART-related techniques.

Public policies for ART can be compared along the dimensions of autonomy and access, using the permissive–restrictive continuum that characterizes the governance of much science policy in general and biomedical policy in particular. More permissive policy goals grant wide access and facilitate a high level of autonomy; more restrictive policies result in more limited access and less self-regulation.

Policy designers, or those who govern in each of the eleven countries in this project, have come up with their own answers to the questions raised by ART. Physicians and researchers are granted varying degrees of autonomy to practise ART or pursue knowledge without outside interference across these eleven countries. The conditions for those who seek access to ART equally vary across countries in terms of what technologies are available and who can profit from them, as well as financial conditions offered by governments and insurance plans in terms of support and coverage.

What might account for this variation in autonomy and access across countries? The following framework proposes different explanatory variables for analysing the designing process and the resulting policy design along the two dimensions of autonomy and access.

What is the Comparative Policy Design Framework?

The Comparative Policy Design Framework (CPDF) guides our collaborative study of ART policy design and helps to explain the resulting policies as well as the similarities and differences across countries. Our approach is the result of both a cooperative and cumulative effort. What we present in this chapter is based on cooperation in the sense that in the process of developing this framework over a period of years, we have depended on our colleagues – both inside and outside the CPDP project – to critique our ideas. The framework is also cumulative: it incorporates, synthesizes and extends three of the dominant approaches to the study of policy-making – institutional analysis, the advocacy coalition framework, and the policy design literature (Linder and Peters 1984, 1987, 1991, 1992; Ostrom 1986, 1990, 1999; Ostrom et al. 1993; Sabatier 1988, 1999a; Sabatier and Jenkins-Smith 1993, 1999; Schneider and Ingram 1988, 1993, 1997; Weimer 1992).

Figure 1.1 identifies a set of variables and relationships that are the important factors characterizing the policy-designing process and resultant policy designs. The framework seeks to explain policy design, which includes goals, the means (or instruments) chosen to achieve them, and definition of target groups. The framework posits that these design choices will be the product of: (1) characteristics of the participating actors, including their beliefs, interests, resources, and relations with each other; (2) institutional rules, norms, and habits that either constrain or shape the designing process and resulting design choices; (3) the nature of the policy designing process itself, which, though structured by predictable factors, is nonetheless dynamic and probabilistic; and (4) the broader context of circumstances, knowledge and opinion, which influences the beliefs, interests, and resources of the participants, and therefore their relations with each other.

Figure 1.1 The CPDP Framework.

We provide operational definitions of our key concepts. Using Figure 1.1 as our guide, we begin with the dependent and intervening variables, policy design and the policy-designing process, respectively. Then, moving from right to left in the figure, we describe and operationalize the three independent variables: actors and actor configurations; institutions; and the broader context.

Policy Design

We use the policy-design literature to inform our conceptualization of the dependent variable – the goals, instruments and portrayal of target groups that make up policy content. This literature is rooted in the policy sciences of Lasswell (1971) and Dror (1971). Driven by a concern for the relationship between the policy-making process and the policies that result, and between the content of policies and their consequences, the policy design literature has a strong normative tradition – a quest for the attributes and facilitators of ‘good policy’ (see, for example, Bobrow and Dryzek 1987; Dror 1971; Dryzek 1983; Dryzek and Ripley 1988; Goggin 1987; Ingraham 1987; Ingram and Schneider 1990, 1991, 1993; Lasswell 1971; Linder and Peters 1984, 1987, 1988, 1989, 1991, 1992; May 1991; Orth 1999; Schneider and Ingram 1988, 1990a, 1993, 1995, 1997). This evaluative focus led policy-design theorists to emphasize the analysis of the content of policy. Through this analysis, two types of insights have been gained. First, by comparing the consequences of policy with its content, we learn about the causal drivers actually at work and their effects in the real world. Second, policy content can be mapped back to the policy-making process that created it. This comparison provides important evidence about the workings of the political process, including which actors have power, what beliefs hold sway, and how information is used. The research that is reported in this book aims at producing this second insight.

Policies, or policy designs, are authoritative decisions, meaning that the decision-makers have the power – or can delegate power to others – to force compliance through sanctions. These binding decisions can take a variety of forms, for example statutes, official government regulations, execu...

Table of contents

• Cover
• Half Title
• Title Page
• Copyright
• Contents
• List of figures
• List of tables
• List of contributors
• Series editor’s preface
• Acknowledgements
• List of abbreviations
• 1. The comparative policy design perspective
• 2. ART policy in Belgium: a bioethical paradise?
• 3. ART policy in Italy: explaining the lack of comprehensive regulation
• 4. Policy networks, federalism and managerial ideas: how ART non-decision in Canada safeguards the autonomy of the medical profession
• 5. The United States: national talk and state action in governing ART
• 6. ART in Spain: technocratic inheritance and modernist aspirations
• 7. The United Kingdom: regulation through a national licensing authority
• 8. France: protecting human dignity while encouraging scientific progress
• 9. The Netherlands: conflict and consensus on ART policy
• 10. Germany: ART policies as embryo protection
• 11. Switzerland: policy design and direct democracy
• 12. Legislation for protection: why Norway designed restrictive policies in the field of ART
• 13. Comparing policy design across countries: what accounts for variation in ART policy?
• Appendix
• Bibliography
• Index