Colleen M Flood & Patrick Dyke, “The Data Divide: Managing the Misalignment in Canada’s Evidentiary Requirements for Drug Regulation and Funding

Working Abstract

Canadian expenditure on pharmaceutical drugs is skyrocketing at a rate which outstrips every other major health care spending category. This is a product of many diverse factors, foremost of which is the glut of ‘me-too’ drugs which provide little or no improvement over alternatives, but are often priced significantly higher than existing treatments. In this paper we argue that a major contributing factor to the climate of increasing costs and diminishing returns is the difference in evidence required at the point of drug regulation and approval (occurring at the federal level) and at the point of public funding (at the provincial level) – what we call the ‘data divide’. The evidence of minimal efficacy required at the licensing stage does not provide meaningful information about a drug’s relative effectiveness and cost-effectiveness. As a result of this data divide, drug funders, physicians and patients in Canada, and many other countries around the world, must make drug funding and treatment decisions with insufficient information about the relative merits of different drugs.

We describe the regulatory and policy circumstances which have led to the data divide in Canada, and how it manifests itself in relation to the needs of decision-makers at the different stages of drug approval, funding and treatment. We then consider several potential solutions to the data divide which may be pursued by provincial drug funders and/or federal drug regulators, including conditional funding programs, changing the standards for ethics approval of clinical trials, and the possibility of harmonization of data requirements.

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