ABSTRACT
This chapter connects the most important policy and institutional changes occurring in France from the 1980s to the late 1990s prior to the European Union (EU)-regulatory regime. While the connections between domestic developments in public health and negotiated processes driven by EU directives may not be obvious at first glance, France's new public health policy provides the parameter for much of the implementation in France. Modernizing public health policy in France involved four major intellectual pillars: health monitoring, the safety of health-care products, the safety of health sites, and the evaluation of good medical practices. In 1996, France enforced EU regulatory requirements by creating a national medical device vigilance structure for the first time. Despite criticism from the medical device industry, supportive studies claimed that patient protection was improved and that risks associated with clinical trials in biomedical research were reduced.
