Industry committee  A product must pass Health Canada tests before it can be marketed in Canada. Currently, medicines exported under CAMR must be tested.

Industry committee  That is true for medicines that are not sold in Canada.

Industry committee  There's an export exemption in the Food and Drugs Act that allows drugs manufactured in Canada to be exempt from the Food and Drugs Act if they are labelled for export only and they do not contravene the laws of the country to which they are consigned.

Industry committee  They still have the choice. As I indicated, the developing countries have regulatory organizations that are very varied in terms of their sophistication. Some smaller countries have no regulatory authority, some have two pharmacists, some have hundreds of pharmacists or a regul

Industry committee  I'd like to address that. Under an exemption, we already export medicines as a country. There is an export exemption in there already. Health Canada doesn't review them. They are labelled for export only, and everybody knows that we have not reviewed them; we will not attest to

Industry committee  Approximately 80% to 85% of the ARVs supplied to the developing countries are being supplied by India.

Industry committee  No. The mandatory review is if the Commissioner of Patents receives a request for a compulsory licence under CAMR. Then the Commissioner of Patents will turn to Health Canada and ask if it meets the requirements of the Food and Drugs Act. We will say yes or no. So those drugs wil

Industry committee  It's optional, and the Food and Drugs Act component of this bill is extremely confusing, but it is one option whereby they can choose whether or not they want a Health Canada review. Right at the moment it is mandatory.

Industry committee  That particular triple therapy was at the request of Médecins Sans Frontières. They had discussed it with Apotex, to produce it; it didn't exist, and it doesn't exist in the brand version either, because the two products are the property of one company and the third is another co

Industry committee  Some...[Inaudible--Editor]

Industry committee  There are two tendering processes. The UN procurement agencies will go through their own tender process. They look to the pre-qualified list, but in the countries themselves...Rwanda, for example, had a law where any procurement would be done by tender. So you're talking about th

Industry committee  Yes, that's right. It would be possible, and certainly with the fact that the distinguishing features are verified by Health Canada through the submission review, we know what they are. We know that they're there and we've already designated what those markings are. When they lea

Industry committee  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 th