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Industry committee  I was just going to add, which might bring clarity to your question, that there are two types of approvals in CAMR. There's approval to get on the list, so the idea is that it's a drug that's needed to deal with a health care emergency. That's not the same as the Health Canada review for health, safety, and efficacy.

October 28th, 2010Committee meeting

Colette Downie

Industry committee  That's correct. It also allows the definition of “authorization” to stand. That definition deletes the possibility of a renewal, so it also creates uncertainty about how long an authorization then stands for.

October 28th, 2010Committee meeting

Colette Downie

Industry committee  That's correct.

October 28th, 2010Committee meeting

Colette Downie

Industry committee  I'll ask my colleague from Justice to explain the role of the definitions in the CAMR legislation.

October 28th, 2010Committee meeting

Colette Downie

Industry committee  If we understand the amendments in Lib-4, what they do is reinsert into CAMR the grounds on which the Federal Court can terminate an authorization under CAMR. Those grounds are where the product is diverted without knowledge of the patent holder, and the second one is really the connection to Lib-5 and Lib-6, which is where the product is exported to a country not named on the list or lists, and where more than the quantity authorized is exported, or where the product is exported to a non-WTO member country and then used for commercial purposes.

October 28th, 2010Committee meeting

Colette Downie

Industry committee  There is still a number of other issues, which we discussed when we appeared before. It still leaves the lack of a mandatory Health Canada review, the unlimited nature of the duration of a licence under CAMR, and some of the other transparency and enforceability safeguards would remain untouched.

October 28th, 2010Committee meeting

Colette Downie

Industry committee  The consequence is that if you were to collapse the country list into one, without distinguishing between the requirements or the manufacturing capacity of different countries, what you would potentially see is the ability to have a compulsory licence to send products to countries that are well developed, or that have their own pharmaceutical manufacturing capacity, in situations where there's no emergency.

October 28th, 2010Committee meeting

Colette Downie

Industry committee  I think we've covered everything we think is relevant.

October 7th, 2010Committee meeting

Colette Downie

Industry committee  We're certainly not formally giving notice.

October 7th, 2010Committee meeting

Colette Downie

Industry committee  It certainly has to notify, that's right.

October 7th, 2010Committee meeting

Colette Downie

Industry committee  Every time the government considers a bill, a private member's bill or otherwise, of course it goes back and looks again at the processes and the proposals to change them. I don't think I can go into the consideration, obviously, by cabinet of what might or might not be done. I will say, though, that one of the things about the Apotex example was that it actually did allow for multiple shipments, in that the authorization was for a total amount, a large amount, which was then shipped as individual shipments.

October 7th, 2010Committee meeting

Colette Downie

Industry committee  I don't have those exact numbers. About 15,600,000 tablets were authorized. About that in total was sent. A first shipment of about 6.7 million tablets was sent, and then another 7.6 million.

October 7th, 2010Committee meeting

Colette Downie

Industry committee  I'm aware of that, but it's second-hand information and concerns some of Rob's predecessors. There have been lots of discussions in the past, I understand, of other possibilities. But again, it's second-hand information. These didn't come to fruition for various reasons, which I'm not actually aware of.

October 7th, 2010Committee meeting

Colette Downie

Industry committee  Yes, it would be the country that would initiate the process.

October 7th, 2010Committee meeting

Colette Downie

Industry committee  Yes, although a manufacturer can also approach a country and say it's interested in providing medicines. There's a notification process, and then it's over to the supplier company to comply with the requirements in camera.

October 7th, 2010Committee meeting

Colette Downie