Industry Committee on Oct. 7th, 2010

[Brigitte Zirger]

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 leave, we know they are on there.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

There is lots of reference to the fact that only one approval has been given, or one drug has actually made it to Africa under the regime. I understand that Canada is the only one that has done it under these World Trade Organization agreements. But there are other drugs making their way to Africa to solve this problem. They're just not happening under this regime. Is that correct? Can you speak to that a little bit in terms of how other drugs are getting to Africa from other countries that might not be part of this?

[Christine Reissmann, Director, AIDS, TB Programming and Health Institutions, Multilateral and Global Programs Branch, Canadian International Development Agency]

Yes, I'd be happy to answer that question.

My colleague already provided some indication of the kinds of multilateral partners we work with. The Global Fund, which is a large multilateral fund to which Canada has just recently provided a large contribution again, spends approximately 45% of its considerable resources on bulk procurement, at good prices, of high-quality drugs.

Another example that we haven't talked much about yet is the Global Drug Facility, of which Canada was an originating partner, and since 2001 Canada has provided over $130 million to what is effectively a bulk procurement system for quality TB drugs.

Those are two good examples. There are many more like that.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

There are so many different questions that I have, but I am going to switch over to the trade side of things for a second.

It strikes me that in leading to these agreements there was a really high intensity of negotiations and literally probably hundreds of people working from several countries around the world on coming to these agreements in the first place in a way that honours international trade rules of law and things like that. Maybe speak to the intensity of negotiations to get to the point where we could actually have a CAMR.

[Robert Ready]

Thanks, Chairman.

I wasn't a participant in those negotiations, but I am aware that they were very intensive. They involved a wide range of the WTO membership and, at the end of the day, resulted in a consensus decision at the WTO, which, as somebody who has been involved in the Doha Round, I can tell you is pretty rare and means that the balance has really been finely struck and people's interests have been protected, respected, but there has been a balance. There was not only a willingness to make progress but a willingness to make sure that the spectrum of issues, ranging from access to medicines but also to protection of intellectual property, was clearly protected all around.

[The Chair, Conservative, David Sweet]

Thank you, Mr. Ready.

Mr. Lake, sorry, your time has expired.

Mr. Masse is next for seven minutes.

[Brian Masse, NDP, Windsor West, ON]

Thank you, Mr. Chair.

This is a critical issue. I find it interesting that in the conclusions it says that Bill C-393 would not overcome the systemic issues of health care delivery and disease prevention in the developing world.

That's almost an absurd statement. I don't know of any organization, group, or interested party that has ever made that claim. Nobody here is saying that this will be the one single solution to human suffering. At the same time, we have a bill that Parliament passed that has only been triggered once. I suppose we have a Parliament that likes to set up legislation that doesn't work or isn't used. We spent a lot of time and money on this, so there's a problem here.

Ms. Downie, you almost indicated that if this is changed, we're going to have all kinds of generic drugs flying out across the world and not be able to track them. But the reality is that the generic drugs must have different markings and different packaging. It has to be stated what country they're going to and the quantity.

What other mechanisms are necessary to protect? You would have a company publicly doing something fraudulent out there. What is the real risk? I don't understand, especially given the Rwanda situation, where we had one out there. What is the threat here? They're still going to be identified, the company still has to identify where they're going, and they're going to be tracked.

[Colette Downie]

Almost all of the requirements to identify where the goods are going and allow the identification and tracking of the goods would be eliminated from the bill. There would be the remaining requirement to post some information on a website. On top of that, enforcement mechanisms in CAMR now would allow if drugs were diverted back to Canada or sent to countries besides countries in the developing world.

There would be no mechanisms by either the government or the Commissioner of Patents to withdraw the licence, challenge it, or say we think these are being used for commercial purposes. The patent holder might not even be aware, in some instances, of what was going where. If they did become aware, there would be no mechanism for them to apply to the Federal Court to say, “These are actually being used for commercial reasons, not humanitarian reasons.”

[Brian Masse, NDP, Windsor West, ON]

My understanding--and we'll seek clarification to make sure--is that markings would not be removed and there still would be an identification process.

[Colette Downie]

Maybe I can clarify that.

[Brian Masse, NDP, Windsor West, ON]

I don't know whether a mistake has been made here, but those are interpretations we've had in the submissions we've made. We'll seek clarification on that, because it's a critical component. We wouldn't want to have drugs not identifiable. I think it's an important piece of evidence that needs to be examined here, because there's no intent to try to have less accountability about where these drugs are going.

I would like to turn my attention to the WTO, TRIPS, and Doha.

Mr. Ready, do you believe this CAMR bill goes as far as what was permitted in those organizations in those decisions, or is it less...in what's permitted?

[Robert Ready]

I'm trying to understand the question with respect to “permitted”. I think the CAMR legislation in Canada seeks to implement the elements of the WTO declaration, and in doing so tracks the WTO declaration pretty closely.

[Brian Masse, NDP, Windsor West, ON]

I guess what I'm getting at here is that this bill has limitations that aren't in the WTO, the Doha, and the TRIPS. I'll give an example. The two-year provision was never there. A list of drugs was never there. The language that's used in TRIPS and Doha is that they have availability without prejudice, other flexibilities are found in TRIPs, and limited exceptions are explicitly intended in that agreement.

I'd like your opinion on whether Canada, in adding those elements to this bill, is not more restrictive of what is available to us under TRIPS, Doha, and the WTO.

[Robert Ready]

Perhaps my colleagues would have an additional comment, but from my understanding of the situation, those elements add some administrative clarity to the users of this process as to the way in which it will be implemented. It's not an attempt to subvert WTO--

[Brian Masse, NDP, Windsor West, ON]

We added lists, though, of drugs that were never contemplated for that, so I defer, I think, to many other experts out there who believe that Canada added a series of components that were hurdles, or more restrictive than what's permitted.

If I may, I would like to move to a comment--this has always been out there--that if we change the legislation of CAMR and it creates an environment where there will be less scientific research and development.... What evidence do you have to back up that statement? Have Rx&D said, for example, if CAMR is used 10 times over 10 years, they're going to invest less than Canada? Has there been any scientific research done to show that this bill is going to undermine Canadian pharmaceutical industries?

[Colette Downie]

No, there is no scientific research to back that up, simply a concern that that would happen. We haven't been told by Rx&D that that's definitely what would happen. You'd have to see what would happen with the changes in the bill to know that that would be the result, though there is economic evidence, and certainly pharmaceutical companies and other patent holders make it really clear that their investment in developing products is really contingent on having strong patent protections.

[Brian Masse, NDP, Windsor West, ON]

Can you provide that economic evidence to us at this committee? Maybe not today, but if you could present that to us at a future date, that would be appreciated.

[Colette Downie]

Yes, and it's not going to relate directly to the development of medicines. It's general economic evidence and studies about the importance of patents to innovation.

[Brian Masse, NDP, Windsor West, ON]

I really find it hard to believe that Rx&D would say, for example...because the Rwanda agreement--

[The Chair, Conservative, David Sweet]

Mr. Masse, sorry, you're well over time.

[Brian Masse, NDP, Windsor West, ON]

I realize, yes. It's restricted.

I can get it in the next round. Thank you, Mr. Chairman.

[The Chair, Conservative, David Sweet]

You can get it in the next round, absolutely.

That concludes our first round. Now we're going to our second round, which is a five-minute round, and on to Mr. McTeague for the Liberal Party.

[Dan McTeague, Liberal, Pickering—Scarborough East, ON]

Thank you for being here.

I bear a bit of an explanation to preface my question.

In 1999 I spoke to the Prime Minister and to our caucus about the need to provide access...given the growing problem in sub-Saharan Africa with respect to the proliferation of AIDS and other attendant diseases such as malaria. It was felt at the time that this was the best approach Canada could take, given its very robust international presence in aiding other nations. It's one I'm very proud of. It's also one of the reasons I think our party is very, very strong, the Liberal Party, on the question of helping Africa where we can.

I know that despite the best intentions.... I've served a bit of time in Foreign Affairs, and I've served well over a decade consecutively on this committee, so I'm painfully familiar with the best attempts by this committee and parliamentarians to do the right thing, but frankly, it has fallen short.

It would appear to me that none of you have been able to bring this together in terms of dealing with the fact that this current arrangement as it stands isn't user-friendly. The process by which negotiations took place to allow a contract to provide, through a generic, as an example, to a particular country is complex, is cumbersome, and it is mired in legalistic and nevertheless important considerations. I'm wondering, among the three departments here, Health, Industry, and in particular Foreign Affairs, where the objective was set, why was there no attempt, in your view, to actually coordinate to ensure that the process could be streamlined in such a way that, for instance, the Canadian government itself would undertake to serve as the contractor to designate to a particular nation AIDS antiretroviral drugs, etc., which was really the intention of the legislation?

[Colette Downie]

I'll look to my colleagues to answer.

I'll simply say that I don't think the legislation was intended to allow the Government of Canada to contract itself. It's really aimed at manufacturers having the ability to--

[Dan McTeague, Liberal, Pickering—Scarborough East, ON]

No, I understand that. I'm simply wondering, given the difficulty, obviously, of the host countries having to go through hurdles with respect to the UN tender, recognizing the in-depth, prolix nature of the 65-page documents that I think some of the companies have had to acquire.... If we're looking at the only example we have, of Rwanda, three separate companies providing three separate drugs, all combined together, how it is that the Canadian government itself, or between yourselves at the departmental level, didn't see red flags going up to suggest that there ought to be better coordination? Because this is not going to work. The intent that Parliament had simply isn't user-friendly. It has not had the desired results.

Why has there been no interdepartmental discussion as to how to fix this problem?