Objective: Canada does not have specific legislation to differentiate drugs for rare diseases unlike the US and European Union. This research aims to quantify the impact of the lack of a formal Canadian rare disease strategy on time for regulatory approval, public HTA assessment and provincial approval for drugs that treat rare diseases. Methods: Utilizing orphan drug (OD) lists from the US FDA and the EMA, we compared approval rates of orphan designated drugs in either jurisdiction between January 2015 to June 2021 with the Health Canada database. Calculation of the relative time to approval to both respective jurisdictions was completed. All OD from this list that were approved in Canada were then examined further for outcomes and timeline from the Canadian Agency for Drugs and Technologies in Health (CADTH) and the pan-Canadian Pharmaceutical Alliance (pCPA) decisions. Results: There were 213 OD identified that were approved in either the US (92%), Europe (72%) or both the US and Europe. Only 51% were approved over the same timeframe in Canada and it took a mean average of 213 days longer compared to the US (median 259 days, SD 606 days) and 305 days longer than the EMA (median 95 days, SD 724 days). Of the approved drugs, 62% had a ‘recommendation’ or ‘recommendation conditional on acceptable cost effectiveness’ and it took on average 276 days (median 165 days, SD 460 days). A high rate of (90%) OD with recommendations from CADTH successfully negotiated with the pCPA which took on average 301 days (median 278 days, SD 200 days). Overall, average time to patient access was 731 days (median 761 days, SD 561 days). Conclusion: Patient access to OD in Canada is significantly delayed. Unfortunately, 40% of medications dedicated to management of rare diseases did not receive the reimbursement in recent years.