I'll try to do this on the fly, then.
As Ms. Downie has already mentioned, Health Canada's regulatory role within Canada's Access to Medicines Regime is three-fold.
Firstly, the department is responsible for undertaking a regulatory review of a drug submission to verify that the product meets the same requirements for safety, efficacy and quality as drugs available to Canadians.
Secondly, Health Canada is responsible for ensuring that the pharmaceutical product is distinguishable from the patented version available in Canada. This is aimed at preventing diversion or re-importation of the product.
Third, Health Canada is responsible for performing pre-export inspections to verify, among other things, the distinguishing features and the quantities to be exported. These details would be stated on the manufacturer's application for compulsory licence that is sent to the Commissioner of Patents.
Now, the products of most interest under CAMR are antiretrovirals used for the treatment of HIV/AIDS. In Canada, the vast majority of these drugs are still under patent protection, which means that Canadian generic versions have not yet been developed. This was the case with Apo-TriAvir.
I would add that submissions that are received and have been received under CAMR are taken into review immediately upon arrival and are completed well within the performance target. These reviews are undertaken with the same diligence as any domestic submission review we undertake, and that is mainly because at the end of that review, and when the patents expire, those drugs can come to Canada.
Companies, whether they are brands or generics, don't develop risk-free products. If they did, Health Canada would never have to issue a negative decision. And it is Health Canada's view that there should be no question of a double standard, nor should there be any concern that a drug leaving Canada destined for humanitarian purposes might be unsafe. Bill C-393 could put this in jeopardy. By removing the mandatory review, it is unclear what safety, efficacy, and quality standards would be applied to drugs exported from Canada under a government-issued compulsory licence.
Maintenance of quality once drugs are in that country and the trade of substandard, falsely labelled, counterfeit, and falsified medicines are serious public health problems. These pose significant challenges to developing countries, which receive drugs from many different sources, including Canada, and where the capacity of national drug regulatory agencies varies significantly. Removing Health Canada's review of drugs exported under CAMR simply moves the drug assessment to lesser-resourced agencies in developing countries or to WHO, which itself depends on regulatory agencies such as Health Canada to do the reviews.
Health Canada, its regulatory counterparts, and organizations like WHO work collaboratively to build regulatory capacity in developing countries. For example, there are quite a number of international harmonization projects, which I've named here but will skip, which focus on the development of lesser-resourced regulatory agencies.
In 2009, Health Canada replaced numerous annual ad hoc visits from these agencies with an international regulatory forum aimed at providing training. The forum is being repeated in two sessions this year and it involves some 27 participating countries. One of them is taking place next week.
We have an HIV vaccine initiative, which is a collaboration between the Government of Canada and the Bill and Melinda Gates Foundation, that is aimed at advancing the science of HIV vaccines and the prevention of mother-to-child transmission of HIV. An element of this collaboration, again, is aimed at capacity-building in the area of vaccines.
Most importantly, Health Canada works with WHO's pre-qualified program, which is actually mentioned in the bill. It aims to ensure that medicines and vaccines for high-burden diseases meet the global standards for safety, efficacy, and quality. The pre-qualified list is used by UN procurement agencies as well as by developing countries when making procurement purchases. Health Canada and many other countries undertake product reviews for this program, and it's because of this work that Apo-TriAvir was added to the pre-qualified list on the basis of Health Canada's product review.
In summary, Canada is committed to increasing access to high-quality medicines and health care in developing countries. Health Canada's role in CAMR is one aspect of this commitment, and so is Health Canada's contribution to building capacity in lesser-resourced regulatory authorities.