Industry committee  I'm sorry. I meant section 21.05. Clause 5 of Bill C-393 would change the current provisions in section 21.05 of the Patent Act by deleting all the references to quantity. It would also add a new proposed section, 21.051, that would put the onus on the authorization holder—the

Industry committee  I'm sorry. I didn't hear you.

Industry committee  Currently it's the Minister of Health who would verify that the labelling requirements, which are a WTO requirement, are met. That's currently in section 21.04 of the Patent Act.

Industry committee  Perhaps I'll start, and then others can respond. As I mentioned earlier on the WTO waiver decision, in light of the concern that there was a need in developing countries but that there was this existing international intellectual property obligation system in place and the mode

Industry committee  I'm sorry. Could you repeat the question for me, please?

Industry committee  I guess we're dealing with the hypothetical, because it didn't happen in the Apotex example.

Industry committee  If we use that as an example, Apotex had already gone through the approval process with Health Canada for that particular drug; that was met. When it applied for the first time for its authorization under CAMR, it took less than two weeks for the Commissioner of Patents to issue

Industry committee  Mr. Masse is correct. Currently, section 21.09 of the Patent Act states that a CAMR authorization is valid for two years from the date of the grant. That was reflective of several WTO requirements in the decision, including paragraph 2(c) of the waiver, which requires a country t

Industry committee  When CAMR was developed and reviewed by Parliament, there was testimony by several pharmaceutical manufacturing companies that the duration of the average pharmaceutical supply contract was two years, so that was taken into consideration. There was also the interest in making s

Industry committee  It's in clause 10 of the bill, which speaks to the renewal of the authorization under CAMR. So yes, there would be the possibility, if the need were identified, that the authorization under CAMR could be extended for another two years to deal with any circumstances that may arise

Industry committee  Yes.

Industry committee  Right, it's clause 10, which deals with section 21.12 of the Patent Act. Clause 9 deals with section 21.09 of the Patent Act and clause 10 deals with section 21.12.

Industry committee  Yes, if you read clauses 9 and 10 of Bill C-393 together, they would allow a CAMR authorization holder to produce and export the drugs authorized in the application indefinitely. That is the consequence of clauses 9 and 10 read together, because there would be no limit to the dur

Industry committee  If clause 9 were struck down? Is that what you're suggesting?

Industry committee  If clause 9 were struck down.... I'll just take a look at it.