Evidence of meeting #37 for Industry, Science and Technology in the 40th Parliament, 3rd Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was camr.
A recording is available from Parliament.
Conservative
Mike Wallace Conservative Burlington, ON
Right. Following up on Mr. Braid's comments, Canada recognizes that and we are doing other things, which you have indicated, to make sure that from a drug perspective we are supporting Africa in general in these areas. Is that correct?
Senior Director, Regional and Geographic Programs - Southern and Eastern Africa, Canadian International Development Agency
Canada has a number of programs to support health in Africa. I've mentioned a few. Yes, that does include providing funding and helping to build the capacity to procure medication and to seek effective use of those medications.
Conservative
Mike Wallace Conservative Burlington, ON
The second point they'd like to make is that CAMR will save lives and that fixing it will save lives. We heard from Health Canada—which I didn't know—that there is a mandatory review of any drug that is shipped overseas now.
Director, Policy Bureau, Therapeutic Products Directorate, Health Products and Food Branch, Department of Health
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 will have had to have gone through a Health Canada review.
Conservative
Mike Wallace Conservative Burlington, ON
Okay. If this bill were to pass, is that still required or is that bypassed?
Director, Policy Bureau, Therapeutic Products Directorate, Health Products and Food Branch, Department of Health
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.
Conservative
Mike Wallace Conservative Burlington, ON
The grandmothers also say, and I don't disagree with them, that sub-Saharan Africans are among those desperately in need of lifesaving, affordable medicines, which is a nice statement, but will the changes in this bill, in your view, make any significant difference in the ability of Third World countries in Africa to be able to either afford drugs or get them there?
Director General, Marketplace Framework Policy Branch, Industry Canada
No, we don't believe it would make a difference, for the reasons we've explained.
Conservative
Mike Wallace Conservative Burlington, ON
We've had some discussion here on number 4. They have people who are claiming that it complies with the WTO and with the TRIPS issues, but based on the bill that is being presented, there are issues within the bill that give us cause for concern that it may not meet those requirements. Is that correct?
Chief Air Negotiator, Department of Foreign Affairs and International Trade
That's the assessment of Foreign Affairs and International Trade, yes.
Conservative
The Chair Conservative David Sweet
On that confirmation, thank you very much, Mr. Ready.
Mr. Wallace, your time has expired. You are well over, actually.
Now we will move on to Mr. Masse for five minutes.
NDP
Brian Masse NDP Windsor West, ON
Thank you, Mr. Chair.
I'll provide this to the clerk to follow up. This is the Journal of the International AIDS Society. They studied the Indian experience with the supply of drugs into Africa. The conclusion is that it's now at risk in the pricing because of the WTO, TRIPS, and other movements they have made. I will table this for the committee, because the current status quo from India is not going to maintain itself and there are going to be rises in costs and prices.
One of the statements you make in your deck here is that Bill C-393 is unlikely to increase demand to use CAMR. Ironically, it is also a threat for Canada with the WTO and everything else. What evidence do you have of that? How do you square that with Apotex, which has said they would use the CAMR more if it were changed?
Director General, Marketplace Framework Policy Branch, Industry Canada
The evidence we have that it wouldn't change is based on what we see and what we experience in the developing world.
NDP
Brian Masse NDP Windsor West, ON
But your only customer taking advantage of this so far has said they would use it more if the legislation were more efficient.
Director General, Marketplace Framework Policy Branch, Industry Canada
Right, but we have to stop to see what.... It could potentially be used for far more than sending drugs to the developing world; it could be used in a broad number of ways.
NDP
Brian Masse NDP Windsor West, ON
So you are suggesting that Apotex has a motivation to use this for other purposes than to do simply more work in Rwanda, for example. Because of the way the legislation is written, when Rwanda found out later on that they needed more medications, they had to actually go back and re-apply; they can't get an extension for more treatments.
So are you suggesting that Apotex is going to try to use this legislation to do something different from what they have done?
Director General, Marketplace Framework Policy Branch, Industry Canada
Not Apotex—no, of course not—but almost anyone can use this regime if it is broadened. It wouldn't necessarily have to be Apotex that would use it.
Why Apotex says it would use it more is I think really a question to ask Apotex.
NDP
Brian Masse NDP Windsor West, ON
But you are suggesting in your deck that you are unlikely to increase demand for CAMR, but then you're saying that the threat is that all of a sudden we're going to have all these other applications by, I guess, other Canadian companies—we could name them all—and yet your only customer is saying that if it were fixed, they would actually use it more.
Director General, Marketplace Framework Policy Branch, Industry Canada
Right. So it's not going to make a difference in the developing world—that is the point we're trying to make—because there are other reasons why medicines aren't going to get there.
Why Apotex says it would make a difference is not clear to me.
NDP
Brian Masse NDP Windsor West, ON
I think it's a little bit conclusive to suggest that Canadian companies would then go on the lurk to try to rip off or undermine the system. Somebody has to do it; you are suggesting that somebody will do it and use the legislation for something unintended.
Director General, Marketplace Framework Policy Branch, Industry Canada
I'm just concerned that it could be the case. I'm not pointing the finger at any particular company or saying that it would be the case.
NDP
Brian Masse NDP Windsor West, ON
No, but you're drawing a conclusion that I think is not fair to the industry and I don't think is representative of the legislation.
I would like to point out another thing that you talked about, respecting the double standard about Health Canada. You've given the interpretation that you would basically have a double standard, such that drugs would go out to other countries without having the Canadian seal of approval. But at the same time, those countries could choose to use their own drug policy. All the bill does is allow a country that may, for example, use the USFDA or the European Union or the World Health Organization.... What's the problem with allowing that? You're suggesting a drug would be made in Canada that is not for sale to Canadian people but then goes through another screening process for another country.
Director, Policy Bureau, Therapeutic Products Directorate, Health Products and Food Branch, Department of Health
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 the safety, efficacy, and quality.
What happens in that case is that the developing countries will require what is called a certificate of pharmaceutical product, a CPP. One of the questions on it is whether the product is marketed in the exporting country. Most developing countries are very suspicious of any products that are coming to them and being sold to developing countries that are not also on the other market. They ask why not.
We were able—
Director, Policy Bureau, Therapeutic Products Directorate, Health Products and Food Branch, Department of Health
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 regulatory capacity. It really varies.
What we're saying is, here is a copy of a drug that is exported under a government compulsory licence, but it's for you to figure out whether or not it meets your needs. They are concentrating at the moment on quality of drugs coming to their country and not necessarily on safety and efficacy.