Thank you, Mr. Chair.
I intend to outline very briefly what Health Canada's role is under the CAMR.
We actually do three things. The first is that the department is responsible for undertaking the regulatory review of drug submissions to verify that the product meets the same requirements for safety, efficacy, and quality as drugs available to Canadians. These are primarily generic drug reviews, so we're comparing a brand and a generic drug and making sure they're comparably acceptable.
Second, we are responsible for ensuring that the pharmaceutical product is distinguishable from the patented version available in Canada, and this is expressed in a regulatory requirement. For example, a solid oral dosage form has to be a different primary colour and it has to have a marking on it so you can tell the difference. This is aimed at preventing diversion or reimportation of the product.
Third, we are responsible for performing pre-export inspections to verify, among other things, that the distinguishing features I've just mentioned are actually in place and that the quantities to be exported are accounted for. These details are stated on the manufacturer's application for the compulsory licence that is sent to the Commissioner of Patents. We really have to coordinate with the commissioner, so when we're done our safety review--our quality, efficacy, and safety--we tell the commissioner we're ready go with the drug and we coordinate our inspections around the product moving from Canada to where it's going.
We have had some experience with the first two stages. In other words, we have received generic drug applications under the regime; they've gotten as far as our reviewing them for safety, efficacy, and quality and then basically putting them on our shelves, so they're ready to go from a food and drug regulations point of view. That includes also the distinguishing features. That means they're sitting waiting for the rest of the process to be completed, namely the licensing part with the Commissioner of Patents.
In terms of our submissions, we actually are very content to keep playing our role in terms of looking at the quality, efficacy, and safety of drug products before they go anywhere. In terms of the inspection, I would caution that we haven't had as much experience with that part yet. It's a newer part under the regime, and until product is ready to move under licence, we won't actually have experience built up around that.
It is Health Canada's view that there should be no question of a double standard--in other words, when we do our drug reviews, it's the same review that we do for domestic purposes for a generic drug--and that there should not be any concerns that a drug leaving Canada destined for humanitarian purposes might be unsafe.
Thank you, Mr. Chair, for the opportunity to present.