What place for economic calculation as a regulatory tool in health care? The introduction of the efficiency criterion in the regulation of reimbursable drug prices in France.

Summary The French legislator integrated the efficiency criterion into the determination of the price of reimbursable drugs in 2012. The efficiency of drugs must be documented for products likely to provide a significant therapeutic benefit and to have a significant impact on health insurance expenditure. It aims to measure the marginal health gain produced by an intervention, compared to the cost and effectiveness of another substitutable intervention. The thesis is based on an empirical analysis of the delegation relationships at work in the regulation of drugs, with a view to their access to reimbursement and the setting of their price in France. It is based on an analysis of three applications of efficiency assessment, reflecting a progressive deepening of the economic evaluation of health care interventions in three distinct institutional contexts. Their comparison allows us to identify the issues raised by the implementation of regulation, the factors of its effectiveness and the associated risks with regard to the theoretical framework of the theory of incentives by asking the following questions: 1) Does the information produced by the economic calculation expose the decision-maker to a risk of manipulation of the tool? 2) Is the contribution of the economic calculation improved in a constrained process of evaluation? 3) Can complementary approaches enrich the economic evaluation and improve its use by revealing other determinants of the health decision? The work in this thesis highlights the contribution of the efficiency criterion to improving the information available to decision-makers. The real risk of regulatory capture can be limited by a more transparent evaluation process and by clarifying the issues at stake in the decision and the objectives of the regulation.