The process of obtaining authorization to market a new medicine in Canada is similar to that in other industrialized countries. However, new medicines are approved in Canada later than in the United States and the European Union because drug developers submit applications later in Canada. For example, Barua, Westcott, and Vo (2021) found that the median difference between submission in Canada and the United States was 170 days, and between submission in Canada and the European Union was 123 days. The question is: why are medicines submitted later in Canada than in the United States and the European Union?

This study explores factors such as population size, geography, and the attractiveness of its pharmaceutical environment that lead to delayed submissions in Canada.

Although it has a population similar to some European countries, Canada is an isolated, geographically huge market with a relatively small population and, therefore, a low population density.

Although population size and geography matter, they are only part of a manufacturer’s decision-making when deciding where to launch new medicines. A favourable pharmaceutical environment is imperative. This includes incentives to encourage manufacturers to submit new medicines for regulatory review, strength of intellectual property rights, processes for health-technology assessment, price negotiation and price regulation, and policies and criteria put in place by insurance providers for coverage and patients’ access to medicines.

Health technology assessment processes in Canada are a major impediment to getting new medicines to patients. Despite claims of independence, the Canadian Agency for Drugs and Technology in Health (CADTH) is owned, funded, and managed by the governments to whom CADTH reports, a clear conflict of duty. CADTH reimbursement recommendations frequently include overly restrictive clinical criteria that patients must satisfy to obtain insurance coverage. These criteria can be questionable and, in some cases, harmful.