The approval of a product for export under the Patent Act is done as the approval for drugs is domestically. That's not what we're talking about.
We're talking about amending the schedules to add a drug to them. That's not necessarily a health approval, although it would be implicit that Health Canada has examined a drug before it would be added. What it's saying is that this drug is useful for the purposes stated in the original purpose clause, which were the humanitarian purposes of making medicines available to the third world that address the named diseases or conditions as well as other epidemics.
The existing schedule 1 is a schedule created based on World Health Organization recommendations of the central medicines that are responsive to the named diseases; that's what is at issue there. As to whether they're safe and efficacious, that will be done through authorization.
Usually what we're talking about when a compulsory licence is given is the circumstance of a manufacturer who has not yet been to Health Canada to have its version of a product approved. We don't know whether that new or second version of an existing product has complied with Health Canada's standards of safety and efficacy and good manufacturing practice. That is something that is done in the course of the authorization; it's not done in terms of building the list.
I'm fearful that this probably didn't help.