"Regulating Healthcare Technologies and Medical Supplies: A Comparative Overview"

A complex relationship exists among EU regulations, current national practices and rules, institutional capacities to implement regulatory adjustments and the legacy of past health and regulatory policy and traditions. However, there is little empirical information on medical devices policy, the medical devices industry, and the assurance of medical device safety and usage. Drawing on a review of the secondary literature and on-going field work, the evidence suggests that the current mix of statecentric and self-regulatory traditions will be as important in determining the implementation and final outcomes of EU-rules as the new rules themselves. EU directives redesign rules, but they do not necessarily lead to institutional change, create institutional capacities, or alter old practices in the short term. Neither EU directives nor national regulatory adjustments determine the "man-machine/skill-experience" interface which is shaped and influenced by local medical traditions and the acceptance of these traditions by local publics

Medical Device Regulation and Nanotechnologies: Determining the Role of Patient Safety Concerns in Policymaking

Balancing acceptable risks and early release of products for new treatments in patient care with the rights of patients and the rights of stakeholders—device makers and regulators—is a complex task. With the rapid technological innovations of the last two decades, providing a balanced voice to all participants is essential, but a sense of urgency depends on which side of the aisle one is sitting: on the side of patients, surgeons, regulators, and device makers, or that of providers and scientific advisors. A review of the medical device political economy suggests why patient safety concerns are or should be kept alive throughout the entire regulatory cycle from clinical evaluation and pre-market checks to their final use in a huge variety of clinical settings around the globe. The key issue for nano-enhanced devices now is whether the uncertainties and perceived risks can be reduced through more stringent regulatory requirements and proactive measures without stifling innovation and development of new treatments for patients

Medical Device Regulation and Nanotechnologies: Determining the Role of Patient Safety Concerns in Policymaking

Balancing acceptable risks and early release of products for new treatments in patient care with the rights of patients and the rights of stakeholders—device makers and regulators—is a complex task. With the rapid technological innovations of the last two decades, providing a balanced voice to all participants is essential, but a sense of urgency depends on which side of the aisle one is sitting: on the side of patients, surgeons, regulators, and device makers, or that of providers and scientific advisors. A review of the medical device political economy suggests why patient safety concerns are or should be kept alive throughout the entire regulatory cycle from clinical evaluation and pre-market checks to their final use in a huge variety of clinical settings around the globe. The key issue for nano-enhanced devices now is whether the uncertainties and perceived risks can be reduced through more stringent regulatory requirements and proactive measures without stifling innovation and development of new treatments for patients

"The Whys and Ways of European Community-Wide Responses to AIDS"

[From the Introduction]. This paper reviews the major decisions and activities of the European Community with regards to AIDS/HIV1 over the last ten years, the complex extra- and intra- Community policy making processes and policy networks from which these actions resulted, and the factors which have allowed the Community to act in some areas but not in others

“European Integration and National Governance: A Comparative Analysis of the Implementation of EU Regulatory Policy on Medical Devices”

Regulatory integration is a central aspect of European integration. Yet the debate about a “European regulatory state” (Majone 1996, 1992; McGowan and Wallace 1996; Begg 1996; and Wilks 1996) largely avoids a fundamental question: who in this emerging “European regulatory state” translates the intent of EU decisions into action? Who disposes of the capacities-organizational, professional, financial, information and communication-necessary for implementing EU regulatory policy? While recent research on the role of European agencies begins to address this issue at the European level (Shapiro 1997; Majone 1997; Dehousse 1997; Kreher 1997; McGowan and Wallace 1996), the findings are often specific to the policy sector (Héritier et al. 1996; American Institute of Contemporary German Studies 1997; Vogel 1997). The following research contributes empirical information to this debate through a detailed discussion of one policy sector-medical devices

"Multi-level implementation networks: The case of medical devices and patient care"

One objective of this paper is to understand the nature and the role of policy networks and multi-level regulatory decision-making systems in the field of medical devices, their composition and activities in a global context. The emphasis is on reconstructing the basic structure of the actors involved in multi-level regulatory processes rather than a systematic examination of the structure of each network type. This paper grows out of an ongoing cross-national research project entitled “Regulatory Regimes in Transition: The Medical Device Sector and Patient Care.” In 1995, it started out as an exploration of the implementation of regulatory policy specific to medical devices in the European Union, focusing on two levels of rule-making and rule-application and drawing a distinction between the formulation of policy and operations to carry it out: 1) the EU level of rule-making and implementation, and 2) the level of national and sub-national implementation. Through focused case studies of domestic implementation in France, Germany, and the United Kingdom, the crossnational comparison has intended to identify similarities and differences in the implementation of European legislation, and shed light on the strengths and weaknesses of their responses at both the policy and levels of implementation from national to local

"Bridging EU and domestic implementation: A cross-national comparison"

This paper tackles a topic of interdisciplinary interest and current policy importance in countries around the world: the regulation of safe efficacious and quality medical devices for use in patient care. Regulation in the field is thirty years behind the regulation of medicines in the European Union, and thirty years behind medical device regulation in the U.S. Specifically, the paper looks at the implementation of three medical device directives in France, Germany, and the United Kingdom, through the lens of domestic implementation literature, evolving over a period of thirty years. The central concerns of this literature arguably coincide with many of the concerns and distinctive features of the historical and sociological version of the new institutionalism rather than rational choice. Questions are raised about the significance of domestic constraints and opportunities in adapting to EU directives on medical devices. What kinds of domestic policy and contextual constraints and opportunities exist? How do they affect the domestic implementation process? What are the domestic outcomes? And, finally, how do we explain variations in outcomes of implementing the same EU directives on medical devices across the three countries