Regulating biomedicine in Belgium and France: neighboring countries, diverging policies.

VerfasserSchiffino, Nathalie
  1. Introduction

    The invention of the technique of in-vitro fertilization (IVF) in the late 1970s and its routinization in the mid-1980s created the basis for new medical techniques, such as intracytoplasmic sperm injection (ICSI), pre-implantation diagnostics, genetic screening and engineering, as well as new fields for biomedical research, such as research on embryos and stem cells, as well as therapeutic and reproductive cloning. The development of these new assisted reproductive technologies (ART) and subsequent biomedical research offers the hope of great benefits, such as the cure of degenerative diseases. However, these innovations have also given rise to grave concerns over their potential negative effects, such as the return of eugenics in the form of embryo selection techniques. In the face of these controversial perspectives, ART and biomedical research have been, since the late-1970s, widely discussed in the media and have become a salient issue on the political agenda (Durant et al. 1998; Gaskell and Bauer 2001; Bauer and Gaskell 2002). Furthermore, a number of advanced industrialized democracies have passed national legislation in response to these debates (for a comparative overview of these "biopolicies", see Bleiklie et al. 2004).

    Our contribution - as political scientists - to the ongoing debates over the regulation of biotechnology consists in examining "how" and "why" governments pursue particular courses of action or inaction (Heidenheimer et al. 1990) in the fields of ART and biomedicine. Hence, we aim primarily to provide a broader empirical knowledge base on how public policies are designed and chosen in two particular European countries, Belgium and France. Despite the considerable amount of political activity and the public attention surrounding these biotechnology issues, there is still a deficit in terms of political science research on this topic (Rothmayr and Varone 2002). This seems particularly evident if we compare what has been undertaken in the growing fields of bioethics, biolaw, and bioeconomics to the still missing - or at least underdeveloped - political science research in "biopolitics".

    At a first glance, one might expect France and Belgium to formulate and implement similar ART policies (see for example Bennett 1998 and Seeliger 1996 on the theory and methodology of "policy convergence"). Several factors could be listed in support of this assertion. First, the French and Belgian publics partly share similar opinions on ART and on biotechnologies in general. The Eurobarometer 58.0 study, for example, revealed that France and Belgium had a similar degree of relative optimism towards biotechnologies from 1991 to 2002 (53% for Belgium and 56% for France in 1991, up to 40% in Belgium and 39% in France in 2002). Both countries obviously supported-in the same proportion -genetic tests, the cloning of human cells and xeno-transplantation, more than they supported genetically modified organisms and food (in 2002, at least 50% support for genetic tests compared to at least 50% opposition to GM food).

    Secondly, Belgium and France are neighboring countries and have several cultural traits in common. This geographical proximity and shared cultural values could facilitate lesson-drawing and policy transfer processes (Rose 1991; Dolowitz and Marsh 1996). Emulation between Belgium and France could, for example, occur if policy-makers in one country were dissatisfied with their ART policies, shared the values of their neighboring state and had knowledge of this state's policies. As an illustration of such a process, Belgian Parliamentarians sometimes mention French decisions or other foreign countries in support of their own bills (1).

    Finally, as investigated in the scientific literature for other countries (see for instance Hoberg 1991 for an analysis of the American influence on Canadian environmental regulation), one could assume that the size of the country affects the policy-making process. The presumption is that larger countries are more likely to influence small states than vice-versa, especially when geographically adjacent to one another. As a matter of fact, Belgium settled a licensing procedure for ART centers (1999) ten years after France (1988). The same time lag applies to the creation of a National Bioethics Committees in France (1983) and Belgium (1995).

    However, a detailed analysis of the ART policies adopted in Belgium and France, and an overview of other bioethical issues (e.g., the partial decriminalization of abortion and euthanasia), show that this common sense presumption of similarity is somewhat misleading: convergence of public opinion, geographical proximity, cultural proximity and differences in size are not sufficient conditions for convergent public policies.

    In the fields of ART and biomedical research, Belgian and French policies strongly differ in terms of their substantive content. We provide two sets of explanations for this variation (based on the theoretical considerations proposed by Varone et al. 2006). The first is actor-driven. The main target-groups (Schneider and Ingram 1993) of the ART policies, i.e. the physicians and the researchers, and the final beneficiaries of these "biopolicies", i.e. patients and political parties (Schmidt 1996), behave in different ways, leading to different policy content. The second set of explanations focuses on institutions. The features of the political systems (e.g., centralization versus federalism) and the influence of "contextual" variables on the internal decision-making process (e.g., the attitude towards international-and especially European -pressure) also help to explain the policy differences. In general terms, the Belgian consensus-style of democracy is based on decisionmaking processes that vary sharply from the French majoritarian system (Lijphart 1999). In the case of ART policies, non-decisions and professional self-regulation resulted in a very liberal policy in Belgium, while we observed more interventionist policies in France.

    Our analysis proceeds in three steps. We begin, first, by describing the development of ART regulation in Belgium and then, secondly, reconstruct the ART policy designing-process in France. In each case, we highlight key elements of the substantive policy content. Thirdly, we undertake a systematic comparison of the decision-making process and constitutive elements (e.g. objectives, instruments, implementation arrangements, target-groups and final beneficiaries) of ART policies in Belgium and France, bringing to light certain obvious similarities and significant differences. We then highlight five factors that contribute to explaining the divergence: the actor networks within the policy sector, the game of political parties within specific governments, the role of administrative agencies in unitary versus federal states, the reaction towards international pressure and, the political sequencing of bioethical issues other than ART. This first empirical analysis of the ART policies adopted in France and Belgium leads us to suggest seven research hypotheses to explain further the "biopolicies" adopted in other countries and biotechnological sectors.

  2. Belgium: the experience of physicians' self-regulation

    2.1. State of the ART in Belgium

    Belgium has been active in every stage of the development and commercialization of ART (Belgian College of Physicians 2002). The extent of the application of ART in Belgium indicates that it is a leading country in the ART domain, both in terms of artificial insemination (AI) as well as in vitro fertilization (IVF).

    Since the 1960s, Professor Schoysman has been developing artificial insemination at the Vrije Universiteit Brussels (VUB). In 1988, there were some twenty centers responding to between 500 and 1000 demands for AI a year (CEDIF 1988). Each center owned its own sperm bank. In 1983, the first Belgian "test tube baby" was born after IVF was performed at the Katholieke Universiteit Leuven (KUL) and then at the Saint Pierre Hospital in Brussels. From 1990 to 1996, the number of IVF cycles grew from 2685 to 3488. Moreover, the team of P. Devroey and A.C. Van Steirteghem at the VUB were the first to implement the technique of Intra-Cytoplasmic Sperm Injection (ICSI), reporting the first successful birth using this technique in 1992. Today, ICSI is a well-known procedure that is applied worldwide.

    Until 1999, ART centers developed without licensing. According to a national report (BelRAP 19951996), 35 centers were active in 1996, with 24 in Flanders, six in Brussels and five in Wallonia, giving Belgium the highest density of ART centers in the world for quite some time. Despite the introduction of new regulations in 1999, the country still faces an oversupply. If we consider that the global average is one center per 700,000 inhabitants, Belgium has 21 official centers (or one center per 500,000 inhabitants) offering a variety of types of ART programs. Thus, there is strong economic competition between the most efficient, i.e. University, centers.

    Since the end of the 1990s, stem cell research has been a very promising area of biomedicine, originating from the use of ART treatments (e.g. supernumerary embryos). Such research can be carried out on embryonic cells or adult cells. The therapeutic benefits lie in the potential ability to treat serious diseases such as Parkinson's or replacing tissue damaged by injuries. It is, however, difficult to precisely delineate scientific stem cell research in Belgium. Research remains confidential until results are officially released in scientific journals. This phenomenon is partly linked to the mostly financial impact of the publication of results. However, research on human embryonic stem cells seems poorly developed. Research on animal embryonic stem cells is more widespread in both Wallonia and Flanders (Antwerp University, KUL, VUB), but this primarily focuses on fundamental...

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