Evidence of meeting #53 for Industry, Science and Technology in the 39th Parliament, 1st Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was health.
A recording is available from Parliament.
Bloc
Guy André Bloc Berthier—Maskinongé, QC
Disseminating the information is a problem at the present time.
Director, Patent Policy, Department of Industry
It would seem so, but that brings us around to your second question concerning measures. Let me recall something that my colleague from CIDA said earlier. What we're dealing with here is a facilitating regime. It allows the private sector -- we're not talking about a government program -- to take advantage of opportunities to sell and export at low cost to developing countries patented generic drugs. Now then, if there are no opportunities, if the countries... That doesn't affect the means. If the means do not exist, everything else is purely “academic”, in some respects.
In terms of level of involvement, I'll let my colleague from CIDA field that question.
Director, Patent Policy, Department of Industry
He wants to talk about CIDA's cooperation in the field with countries abroad.
Bloc
Guy André Bloc Berthier—Maskinongé, QC
Would one option be to increase the level of cooperation with CIDA?
Team Leader, HIV-AIDS, Canadian International Development Agency
If you don't mind, I'll answer that question in English, since it's easier for me and my answer will be clearer.
What I tried to do was present an illustrative example of where CIDA is engaged in health, and as I mentioned, we're not in every country. You named a couple of countries; as I say, CIDA can't engage in the health sector in every country, but in those countries in which we are very active, yes, we are helping them through their ministries of health and through civil societies that engage in health. We are very active and very engaged, both in dialogue and in providing support to present those means for those countries to be able to access medicines.
Absolutely, there continue to be challenges. You mentioned, I think, a couple of the poorest countries in the world. Those are obviously where the challenges are the greatest, where the health systems are not what they need to be and should be. Collectively, as a global community, we need to address those things, and Canada is participating in that.
Conservative
Conservative
Dave Van Kesteren Conservative Chatham-Kent—Essex, ON
Thank you, Mr. Chair. Thank you, everybody, for attending.
This is a very complex issue. It's somewhat confusing. On the one hand, it would appear that we're responsible, and on the other hand, it would appear that there's responsibility on the other side, and we're all trying to find the same logical conclusion.
I'm going to ask you to give me a very clear answer to explain the straightforward process--and it should be a straightforward process--to obtain drugs under CAMR. I'll ask Mr. Armstrong first. What's the process?
Conservative
Team Leader, HIV-AIDS, Canadian International Development Agency
In terms of the process of using CAMR, Industry Canada is in a better position.
Conservative
Dave Van Kesteren Conservative Chatham-Kent—Essex, ON
I'm sorry. Okay, Mr. Clark.
Anybody else can jump in. I have another question as well.
Director, Patent Policy, Department of Industry
I'll sketch out notionally what the process could be, although the steps I will describe in sequence will be intuitive. They're not necessarily under the legislation chronologically.
Notionally the first step would be for a developing country, an eligible importing country, to notify the WTO, if it's a WTO member--or Canada, if it's a non-member--of its need for a particular drug. It would identify the drug and the quantity needed.
Then it depends on their development status. If they're a least developed country, they don't have to indicate anything. If they're a developing country, they have to indicate that they have insufficient manufacturing capacity for that drug. If they're another category of developing country, which has agreed to avail itself of the regime only in situations of extreme urgency or national emergency, they would have to indicate that.
That would be notional step one.
Conservative
Conservative
Dave Van Kesteren Conservative Chatham-Kent—Essex, ON
I have another question.
If this is profit driven.... I really get kind of cynical, because I'm looking at all sides here, and I was really surprised to see that China was part of this process too.
First of all, can a generic company--say, a Chinese company--get a licence from a Canadian company, or does it have to be under the framework of that individual country?
Director, Patent Policy, Department of Industry
Patent law is territorial in nature, so if you're looking to avail yourself of a Canadian regime, you have to do so in Canada. It could apply to that Chinese company if the manufacturing was taking place in Canada.
Conservative
Dave Van Kesteren Conservative Chatham-Kent—Essex, ON
All right. Does anybody else want to add to that?
I, too, think you've answered that question pretty well.
Now—and maybe this can go across the floor—explain your role and responsibilities of involvement within Canada's access to medicines regime. What is your role?
Maybe Mr. Clark could reply and then Mr. Armstrong. I want to get CIDA in.
Director, Patent Policy, Department of Industry
Well, we're policy. We're responsible for the legislation that provides the legal framework to the regime, to some extent, at least on the patent side.
And then, David....
Director, Office of Patented Medicines and Liaison, Therapeutic Products Directorate, Health Products and Food Branch, Department of Health
At Health Canada, we're responsible to make sure that before any drug is exported from here under the patent regime, it's safe, efficacious, and of high quality. So it's the same as a Canadian citizen would get; no double standard. Plus, we have to make sure that the markings for diversion are present so that the drug is sent over and is different from the brand-patented product here in Canada.
Conservative
Dave Van Kesteren Conservative Chatham-Kent—Essex, ON
So is it standard across all the different countries? Would it be about the same as the Canadian standards? Is it universal?
Director, Office of Patented Medicines and Liaison, Therapeutic Products Directorate, Health Products and Food Branch, Department of Health
They're not perfectly universal, but in terms of generic drug review they're fairly similar.
Conservative
Dave Van Kesteren Conservative Chatham-Kent—Essex, ON
In all the talking we can do, the fact of the matter remains that before this process can begin, you need an application from a host country, a country that has an epidemic or something, and that quite frankly hasn't happened.
Director, Patent Policy, Department of Industry
It's not that it has to start by that step. As I said, that's a notional, logical sequence of events. All I'm saying is that before the licence could be granted, that would have to happen, and that hasn't happened.
We've already had generic companies approach Health Canada and seek approval for a generic version of a patented drug that they were contemplating exporting under the regime. There's nothing to prevent them from doing that in the absence of a notification to the WTO, but before that can ever crystallize into an actual licence under the regime, that notification has to take place.
I was just saying, notionally, logically, you would think that would be the first step in the process, but it hasn't happened.
Conservative
