People with diabetes should have timely access to new and appropriate treatments at an affordable price.
The government of Canada should allocate the necessary resources and implement more stringent measures of accountability to create a drug and medical device review process which is timely, transparent and incorporates a functional post-market surveillance system.
Post-market surveillance is the process of monitoring a new drug once it has been approved and introduced into the market to ensure that unfavorable effects are reported, documented and addressed.
Background and rationale
The government of Canada is responsible for the review and approval of new drugs and medical devices. The current system has been criticized for being slow, overly-complicated, under-resourced, and lacking a sufficient focus on product review and evaluation (particularly in comparison with other countries). As a result, there is concern that pharmaceutical companies are discouraged from introducing new drugs into the Canadian market. While it is vital to ensure that new treatments for people with diabetes are safe and efficacious prior to approval, access to new treatments should be available without undue delay, particularly if the delay is clearly a result of the process being under-resourced.