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Article Excerpt
Introduction
In their article referring to the "constitutional asymmetry" in European Union (EU) policy making, (2) Permanand and Mossialos (2005) seek to explain why, despite the existence of a Community regulatory regime for pharmaceuticals for some 40 years, (3) there is still no single European market in prescription drugs. At the core of their explanation is an alleged "clash" between the supranational free movement rules (the driving force of industrial policy, which is preferred by the relevant stakeholders) and national health policy competencies (which, under the principle of subsidiarity, sees certain policy competencies undertaken at the lowest level at which they can best be pursued). An additional complication is that this clash takes place against the backdrop of limited public health advocacy at the EU level. Although launched some 20 years later as an integral part of the single European market (SEM) project during the late 1980s, medical device regulation faces similar conditions. Market-biased EU rules for industrial and trade policy, which are reinforced by treaty-based provisions and free movement-oriented rulings of the European Court of Justice (ECJ), exist in tandem with weak EU public health competencies. For both sectors, therefore, despite distinct and more or less legally and procedurally unified EU regulatory frameworks, there is still no EU-wide market in the manner of other more traditional industrial products. The purpose of this paper is to compare EU medical device and pharmaceutical regulation and policy, and to ask why and how the two regulatory regimes differ.
Before delving into the details of the comparison, it is to be clarified that our research questions start from a EU perspective. We are solely concerned with how regulatory issues are framed in the immediate aftermath of the creation of the SEM in 1986 and the related shift of regulatory authority away from the member states to the EU institutions. These are now endowed with considerable powers over regional and international trade, competitiveness, and competition law. We are not concerned with national-level divergences or in international comparisons, where taking account of differing therapeutic cultures and traditions poses difficulties for a broader analysis (Daemmrich, 2004). While the regulation of prescription drugs and medical devices is primarily concerned with health and safety issues, public health and the protection of patients from harm, the primary objective of EU regulation in these two sectors was the creation of a regionally integrated market, and the facilitation of trade within this market by selecting a so-called "new approach" to technical harmonization with scientific standards at its core. The circumstances of such regulation are unusual, and hardly comparable to the nation-state context of regulation and regulatory politics.
Our comparison proceeds in several steps. We first outline the issues that we aim to clarify in analyzing the similarities and differences between the regulatory regimes for medical devices and pharmaceuticals. Next, in addition to the "clash" between economic and social imperatives, we address another paradox in the regulation of the two sectors: despite the proliferation of EU competencies, national-level regulation has in fact increased. We then seek to ground the comparison in pertinent scholarship on EU integration and policy making, before then highlighting regulatory differences in reference to the "regulatory life cycle" concept. (4) This helps set the backdrop to exploring in detail the reasons for the differences between the two regimes. By way of conclusion, we will draw out the empirical lessons learned. Ideally, they will form the basis for theorizing concerning this topic as the research develops further.
Literature
A Common Constitutional-Institutional Framework, Yet Different Regulatory Regimes
The pharmaceutical and medical device industries are both indispensable to the delivery of health care and clinical innovation, and not just in Europe. Both manufacture products that are highly sensitive, and which represent vital public goods that play an essential role in the provision of health care, the restoration of health and well-being, and the avoidance of premature death (Faunce, 2006). Drugs and medical devices are crucial for clinical research and innovation, yet both can pose severe risks to human health if poorly regulated or inappropriately used. Thus, the object of regulating drugs and medical devices is not only to promote their international and regional trade--and to enhance the competitiveness of (the European) industry--but, above all, to serve public health needs. More specifically, they must meet the objectives of safety, quality, and efficacy--the three regulatory approval "hurdles"--upon which national health protection schemes and health care systems have come to rely (this also raises the issue of the so-called "fourth" and "fifth" hurdles in the interest of regulating for public health and patient safety). (5) To meet these and other expectations, the EU has set an extraordinarily ambitious policy objective for public health and consumer safety in general. Not only does the EU aim to "promote the interests of consumers and to ensure a high level of consumer protection", the Community shall [also] "contribute to protecting the health, safety and economic interests of consumers." Moreover, "a high level of human health protection shall be ensured in the definition and implementation of all Community policies and activities." Policy rhetoric aside, realizing these goals is an on-going process of learning by doing and seeking consensus through compromise and conflict resolution; the medical device and pharmaceutical sectors represent cases-in-point.
in terms of the EU policy environment, both sectors are exposed to similar EU interventions according to treaty-based competences and ECJ court rulings. Moreover, they are subject to similar European-level conditions--constitutional, political, institutional, and economic, as well as judicial (independent variable)--regarding market access, international trade relations and regulatory convergence, and the competitiveness of industry. Nevertheless, important differences remain. Are these similarities and differences the result of the differences in timing at the start of EU regulation in each sector? Or is the divergence related to the power of the stakeholders which control the respective EU and national "regulatory space"? Do political and institutional traditions unique to each regulatory regime explain the differences? Should variations in stringency be anticipated as a result of some fundamental differences in the nature of drugs and medical devices? Finally, do these differences stem from the respective interface with national health protection schemes and the way they are treated as covered and reimbursable items? Through process-tracing each phase in the regulatory life cycle, this paper aims to address such questions, and will do so by connecting insights from three distinct academic traditions: political science, EU studies, and health policy research. Our comparison necessitates a multidisciplinary approach that combines conceptual and more applied social science.
In attempting to understand this situation, therefore, rather than engaging in a theoretical discussion, this paper aims to explain what these differences are, to identify their root causes, and to consider the implications for knowledge about European public policy (which is inherently comparative). Our comparison is theoretically modest, and we instead look to address an empirical gap as a first step. Beyond the issues raised above, we are primarily interested in answers to two crucial questions. First, why, despite more or less uniform market-access conditions on the one hand, and an equally central role in the member states' respective national health protection schemes on the other, does empirical research on pharmaceuticals and medical devices point to a number of unexpected differences between the two sectors while at the same time revealing few expected similarities? Second, what is there to be learned from a comparison of EU regulation of medical devices versus that of pharmaceuticals? To the extent that problem-driven empirical research generates descriptive material, and enables us to identify patterns of behavior, action, and procedures, this paper should be considered as a first contribution to theory development about EU regulatory policy in this area.
Methodology
There are many ways of engaging in a comparison (e.g., similar and dissimilar research design, longitudinal approaches), and this paper represents a functional comparison of drug and medical device regulation in the EU context, drawing on previous research by the authors, an extensive review of relevant literature, and fieldwork by each author. In contrasting similarities and differences in stringency of regulation, we will also explore the balance struck between trade and international competitiveness, public health and health care policy objectives in the European Union. Permanand (2006) has adopted this three-part policy-balancing approach to examine EU pharmaceutical policy, and we find this framework as a useful backdrop to be borne in mind throughout the discussion. We thus incorporate the key characteristics that best describe the core activities in each policy sector. Table 1 captures a first set of commonalities and sector-specific features to which we will return at a later stage.
The table highlights the multiple and overlapping policy dimensions in respect of regulatory policies for medical devices and pharmaceuticals. It is clear that there are similar or shared priorities in respect of public health requirements and cost-containment concerns. But there are differences vis-a-vis industry interests and resultant policy implications.
Results and Discussion
The "Paradox" of Regulation and the CE Marking System
This "clash" or asymmetry between coherent EU rules in favor of trade and competition and the heterogeneous objectives and rationale of national health protection schemes, is compounded by another paradox reported for EU product regulation in general. (6) Despite much regulatory reform--through mutual recognition of the equivalence of technical standards and testing and certification procedures, including confidence-building measures, approximation, and other means--and the liberalization of the European market over the last 25 years or so, the trend in national product regulation of foodstuffs, pharmaceuticals and medical devices has actually increased since the mid-1980s in the push toward the single market (Joerges & Vos, 1999). For prescription drugs this is evidenced in the increasing number of notifications to the Commission per year, and the fact that national regulatory activities have not ceased (Pelkmans, Vos, & Di Mauro, 2000). For medical devices, the regulatory situation and the evidence are similar. A member state that plans to require higher public health standards in any new legislation has to notify the Commission about such intentions, notably when such a new provision may run counter to EU stipulations. In the case of medical devices, notification can concern, first, conformity assessment with...
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