It is a regulatory barrier because the solution to it is to register them. The cost to register them and the barriers to support that registration are so high that in some ways companies that have these products in other markets say, “Why bother going through this burden when, if the patient needs it, they'll import it?” These are typically for small-market products for small needs.
Instead of doing the right thing about registering them, they can do without it. No one is forcing them to do it.
I think a better approach would be to look at these needs and have Health Canada say, “We want to have these products approved. We want to review them. Let's do it the right way, but let's realize that these aren't blockbusters, and let's not charge a fee. Let's use policy the right way.”