Les enjeux de la régulation dans un système complexe : le cas du Régime général d'assurance médicaments du Québec (RGAM)

In 1997, the Quebec government, in its desire for social justice and solidarity among all Quebecers, introduced the Régime général d’assurance médicaments (General Prescription Drug Insurance Plan) (RGAM) to provide reasonable and fair access to medication to better manage the health of individuals. Since the establishment of the Plan, the steady rise in drug costs has been the subject of a growing number of debates. Quebec is not an exception because in recent decades, the increase in drug expenditures of drug plans in industrialized countries has grown exponentially despite the successive introduction of regulatory mechanisms aiming to better control drug use and its expenditure trajectory.  The study proposes a reflection on the common frameworks of action in which the regulatory mechanisms of prescription drug expenditures covered by the RGAM are established and evolve. The study focuses on the set of relational and contextual factors that constitute these frameworks. The research design is based on a single case study, that of the process leading to the use of prescription drugs covered by the RGAM. It consists of three units of analysis identified as important targets of regulation: registration of medications on the RGAM drug list, prescription, and access to medications covered by the Plan. The conceptual perspective adopted is the strategic analysis of Crozier & Friedberg (1987). The analysis is based on interviews with regulators, manufacturers of patented drugs and generics, physicians, pharmacists, and patients involved in the use of medications reimbursed by the RGAM, and on a review of the regulatory system concerning these actors, prescription drugs, and the RGAM.  The study describes and analyzes the structure of the process leading to the use of medications covered by the RGAM. The study leads to the development of an organizational construct—a concrete action system—based on the interdependencies of the five groups of actors and the power relations that exist between them. These actors operate in unique organizational contexts consisting of challenges, strategies, and resources. The actors develop various strategies to increase their possibilities for action (strategic capabilities) toward the problems they must solve. These strategic capabilities, which are unequal between the groups of actors, stem from the power relations that exist between the actors and lead them to occupy different positions in the concrete action system. The study demonstrates that, based on the strategic capabilities they have, the actors are likely to appropriate certain rules by attempting to influence them, circumvent them, or not respect them.  Empirical knowledge of the common frameworks of action allows establishing the basis for a concrete action system in the context of the “organization phenomenon” (Friedberg, 1997). This knowledge, on the one hand, establishes that the impact of certain strategies of the actors may be incompatible with the objectives of the RGAM, and on the other hand, imposes limits on certain regulatory mechanisms in force, while questioning how regulations are conceived in a complex system.

Keyphrases: Power, Assurance médicaments, Drug plan, Regulation, Organization, Complexity