Medical Devices: European Union Policymaking and the Implementation of Health and Patient Safety in France Book

List of Tables and Figures     ix
List of Websites     xiii
List of Abbreviations and Acronyms     xv
Foreword     xxv
Acknowledgements     xxix
The European Union, France, and Medical Devices in Context     1
An Introduction to Medical Devices
What is Known about Medical Devices?
EU Medical Device Policymaking
Why a Single Case Makes for Good Lessons
Important Questions about French Health Care
Health Crises and Institutional Change
The Domestic Coordination of EU Policy in France
The Medical Device Industry in Europe and France     31
Payers and the Industry: A Divided Table
Innovation and R&D: Handicapped by Lack of an Industrial Policy
Limited Innovative Capacities
Interest Intermediation and Industry Profile
The In Vitro Diagnostic Industry
The Home Health-Care Industry
EU Policymaking on Medical Devices     59
Medical Devices and Drugs
Public Spending and Health Protection
The Dynamics of European Integration
Targets and Forms of Interventions and Responses
A Fourth Directive on Human Engineered Products
Assistance from an Unlikely Source
Policymaking and Politics in France
A New Public Health Safety Policy: The Same Old Structural Problems     87
Agenda Control: Who is in Charge?
The French Public Health-Care Policy Agenda in the 1990s
Securite Sanitaire: Crusading against Health Risks
Four Principles of Public Health
The Precautionary Principle: Moving Away fromZero-Risk
Risk Management and Vigilance Systems
Biomedical Research
More Restructuring of State Governance     101
The Law of July 1, 1998
Two Distinctive Features: French Etatisme and Scientific Advice
State Reliance on Scientific Advice
Le Comite National de la Securite Sanitaire
Regulation in France     111
Established Practices
Path-Dependent Processes and Structures
From Homologation to Materiovigilance, 1990-1996
Stakeholders
The Ministry of Health
National Commission of Homologation (CNH)
Groups of Experts
Test Laboratories
Sites for Clinical Trials
Settling Disputes: The IGAS Report
The Ministry of Health: A Weak, Low- Status Player     123
Roles and Responsibilities
The Active Implantable Medical Device Directive (AIMDD)
The Medical Device Directive (MDD)
The In Vitro Diagnostic Directive (IVDD)
Bureaucratic Politics
Negotiating the EU Directives in Brussels, 1990-1998     135
Negotiations
Delegations to Brussels
Why the Fuss about IVD Products?
Handling Reagents (Reactifs)
French Inter-Agency Conflicts
From AdM to AFSSAPS     145
The Institutional Legacy of the Medicinal Agency
A New Regulatory Agency
New Responsibilities and Tasks
The Organization of "First Generation" AFSSAPS
Intra-Organization Relations and Product Orientation
Inspection
Medical Devices Evaluation Directorate
Capacity-Building: Recruiting Knowledge and Manpower
Funding Levels: How Much is a Risk Policy Worth?
The Post-2004 Era: New Wine in Old Bottles?
Implementing the IVD Regulatory Regime     169
Processes, Issues, and Problems
Commissions and Conflict of Interest
Reactovigilance
Medical Device Vigilance     183
Europeanizing and "Francosizing," 1996-2000
The National Organization after 1996: Pillars, Composition, and Process
What Happened after a Report Was Received by AFSSAPS?
La Commission Nationale de la Materiovigilance (CNMV)
CNMV under AFSSAPS' Leadership
CNMV Working Environment
The Reporting of Adverse Incidents, 1996-1999
The Issue of Training
The Pre-and Post-AFSSAPS Era: A Comparative Perspective
The Ministry of Health
Adverse Incidents Reporting Compared
Local Operations: Regulations in the Hospital     207
Regulation and Hospitals
Assistance Publique-Hopitaux de Paris (AP-HP)
AFSSAPS and Local Vigilance Officers
Conclusion and Lessons Learned     217
France and a Model Regulatory Program for Medical Devices
Eight Guiding Principles
From a Single Case to Universal Lessons
Drivers of Medical Technology
Global Harmonization of Regulatory Practices
References     243
Government Documents     261
Index     267