Emergent Patterns in the Regulation of Pharmaceuticals: Institutions and Interests in the United States, Canada, Britain, and France

Abstract

Although industrialized nations regulate pharmaceuticals to ensure their safety and efficacy, they balance these concerns with those related to the timeliness of the approval process and the burdens involved in meeting regulatory criteria. The United States, Canada, Britain, and France have adopted different approaches to the regulation of pharmaceuticals that place varying emphases on these competing goals and involve the participation of private interests to different extents. The regulatory approval processes and the government-industry relationships inherent within them are compared in the United States, Canada, Britain, and France by analyzing five features that distinguish the U.S. pluralist from the European corporatist approaches to policy development: representation (internal versus external), process (closed versus open), stance (informal, accommodative versus formal, adversarial), institutional power (fragmented versus centralized), and resources. An institutional framework further characterizes these approaches as based on models of managerial discretion and adjudication (United States), consultation (Canada), and bargaining (Britain, France) to clarify the patterns that emerge. While the approach that most effectively supports product safety involves managerial discretion as occurs in the United States, formal mechanisms for negotiation might be incorporated rather than a reliance on the judicial process. In an era of globalization and regulatory harmonization such divergence has significant implications. First, where harmonization in Europe involves the mutual recognition of one country's product licensing decision by the others, differences in evaluative processes remain important. Second, as harmonization leads to a common set of regulatory criteria, the criteria adopted tend to be those of nations with the least stringent regulatory standards, making evident the need for more responsive systems of post-market surveillance to protect the public interest.

A suggestion for evolution of Canada’s health regulatory system

“…Some provincial officials are also concerned about how adverse reactions are being reported ). The Canadian Medical Association has claimed that the TPD does not provide acceptable warning of potential adverse reactions (Wiktorowicz 2003). Health Canada has also stated that if no further changes are to be made to the drug and it does not cause any adverse effects, it may never have to be reviewed again (Health Canada 2007a).…”

Regulatory Oversight or Lack of Foresight? Implications for Product Recall Policies and Procedures

“…The system is largely dependent on self-reports from the organizations provided during pre-announced site visits rather than on independent quality control assessments or unannounced inspections. The system is thus similar to the accommodatory and cooperative-based approach used in many European countries rather Lynne Eagle et al than the adversarial approach used in the USA (Wiktorowicz, 2003), although the relative merits of these two philosophies appear to have not been systematically evaluated.…”

Rol del estado en los ensayos clínicos

“…Para ello, los Estados tienen la obligación de elaborar normas, vigilar su cumplimiento y aplicar los tratados internacionales en el desarrollo de los ensayos clínicos (1,2) . Sin embargo, la implementación de estas normas no se aplica por igual a todas las realidades, y podría representar un obstáculo en el desarrollo de nuevos ensayos clínicos.…”