Industry Committee on Oct. 7th, 2010

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

Thank you, Mr. Chair.

If I had one word to describe my personal experience with Bill C-393, it would be the word “agonizing”. Let me define what I mean here, because it's not often a politician will talk about an experience as being agonizing. It's agonizing in the sense that I believe so much in the high-level objective of CAMR, which is to provide much needed medicine to people who are in need of it, and I've been solicited by a huge number of people who feel passionately about it. At the same time, I have not been convinced that this particular bill will solve that problem. Your testimony today generally supports my thinking, in the sense that you have pointed out what it can do and what it can't do and what it risks causing in terms of problems and other realities.

I want to start with something you said, Ms. Downie, at the very beginning. It is that the biggest problem is the result of poverty; it's not the result of a problem with our patent law. I'd like to ask you, perhaps, to expand a little bit more on that statement.

[Colette Downie]

I think my colleagues from CIDA would be the best people to talk about what the situation is like on the ground and in reality.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

Very good.

[Louise Clément]

When it comes to improving the delivery of health services to developing countries where poverty is very prevalent, it is a very complex issue that involves a number of challenges, including, for example, not having access to health care. There are countries where people have to walk several miles to be able to have access to basic health services. That's one problem. Another problem is lack of predictable resources to be able to put in place a solid health plan in the country. Another problem, of course, is access to medicine. There are others. There are issues related to the capacity of the government.

What Canada is doing, as I mentioned earlier, is dealing with key partners who have experience, working with them in collaboration in order to take a holistic approach to support improved health in developing countries. I've mentioned a few examples: the Muskoka initiative, the Global Fund, the GAVI Alliance. There are others.

Maybe another example that I can provide is the Africa health systems initiative, an initiative that was announced in 2006 by the Prime Minister. It involves $450 million over 10 years, directed to Africa, and the objective is to build health systems in Africa. Specifically, it has three dimensions. One is to increase the number of health workers. That's a key problem. The other is to improve access to ensure that there are health services provided to people in the most difficult areas in the country. The third element is to build health information systems for better planning and better delivery of health systems.

It is a very complex issue that involves a partnership of many global players--Canada and many donors--as well as increased coordination with the partner countries with which we work. Essentially what we're trying to do is to build the capacity of our partner countries to be able, in the long term, to deliver their health services on their own.

I hope that answers the question.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

Yes. Indeed, it is a complex problem, there's no question about it.

Reference was made to the fact that some of the countries in Africa are getting their medicines from other, cheaper sources, and it's in many ways a challenge for Canada, because of labour costs and other things, to actually undercut those prices.

Another issue related to it is the consequence of our reputation with respect to our IP regime. I think that is something we can't overlook. I've read some of the testimony from S-232, the Senate bill, that's very similar to C-393.

One of the witnesses was Richard Dearden. He was representing Gowling Lafleur Henderson. He went so far as to say:

First, Bill S-232's one-licence regime is not authorized by flexibilities that are found in the TRIPS Agreement. Second, TRIPS Article 30's limited exceptions provision does not authorize Canada to abrogate its compulsory licence obligations.

I won't go on. I know that's not agreed to by those who feel that TRIPS is not violated, but I would like to hear from you, sir, from Foreign Affairs, on your interpretation of whether or not that is the case, that we are in danger of violating our TRIPS agreement with respect to C-393.

[Robert Ready]

Chairman, thank you.

With respect to the issue of the relationship between amendments to CAMR and WTO obligations, the first thing I need to say is that of course it's only at the conclusion of a dispute settlement process in the WTO that you know with any complete certainty that there's been a violation found. Up until that point, it's a series of allegations, arguments, and interpretations.

Certainly the policy analysis that has been done in the Department of Foreign Affairs and International Trade on this issue suggests that to the extent that the CAMR is amended in such a way as to no longer reflect or implement the terms of what is a waiver from TRIPS obligations, the risk increases that we'll be off-side of those TRIPS obligations. I think that's the best answer I can give you at this point.

[The Chair, Conservative, David Sweet]

Thank you, Mr. Ready. And thank you, Mr. Garneau. That was a few seconds over.

Mr. Malo, you have the floor for seven minutes.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Thank you very much, Mr. Chair.

Like Ms. Wasylycia-Leis, I am also my party's health critic. Basically, she expressed what we are all feeling. Since the regime was first implemented, only one drug has been shipped overseas for humanitarian purposes. In an effort to resolve this issue, she tabled Bill C-393. However, you have looked at the proposed legislation and you indicated to us during your opening remarks that this option presents a number of risks, as we feel it does. In fact, you do not believe that the solution she is advocating is the right one.

As we consider Bill C-393, Mr. Chair, we also need to ask ourselves why a number of NGOs believe the regime is not working. We need to look at whether the regime can be made more flexible. That's why we came up with a list of about twenty potential witnesses, to help us conduct a more in-depth study and look beyond Bill C-393. I hope committee members will agree to this proposal, Mr. Chair. I really think that we need to take a closer look at this regime and ask the questions that need to be asked. It has been in place for some time now and the only example that applies is the case of Rwanda and Apotex.

Ms. Downie, you stated in your closing remarks that the regime is working. Several NGOs would disagree with your assessment and would argue that only one drug has been exported as a result of the CAMR mechanism. So then, how can you claim the regime is working?

[Colette Downie]

To answer your question, the regime does what it can do. We do have a regime, the only one of the others in the world that has actually resulted in a shipment.

The reason there haven't been more shipments is not because of the structure of our patent regime and CAMR; it's because of all of the other problems and issues my colleagues have mentioned that make it very, very difficult to get medicines to the developing world.

It's not to say--and I hope I didn't leave you with that impression--that the one shipment is the only shipment of patented medicines, or copies of medicines, that has been sent to the developing world. There are lots of other mechanisms by which they're getting there.

Clearly there will be concern by some of the witnesses you'll probably hear from that more needs to be done. But the solution is not to open up the CAMR regime. That by itself won't result in any more shipments.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Are there other options that we could be exploring? In your concluding remarks, you stated that CAMR is only one of the tools that Canada uses. Are there other lesser known tools? NGOs maintain that the regime isn't working. This morning, I'd like us to try and answer the question as to why the regime is failing. You made it clear in your closing remarks that Bill C-393 will not result in more applications being filed under CAMR. Could we be exploring other options?

[Colette Downie]

Canada does do some outreach to make it clear what the regime does, and maybe Rob could expand on that a little.

I think, though, when Canadian manufacturers face competition, when developing countries can get cheaper medicines from other countries such as China and India.... They may be aware of CAMR and a mechanism by which to get them from Canada, but they would have no reason to use it when they can get cheaper medicines from elsewhere.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

So then, there are other examples internationally that we could be looking at and evaluating?

[Colette Downie]

Other access to medicines regimes?

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

For instance, yes.

[Colette Downie]

There are regimes that have different characteristics in Canada. Some of them are laxer or less specific in some areas, but none of those has actually resulted in a shipment of drugs under those regimes. I don't think the solution lies there, because if there was a solution, we would have seen those regimes used.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

So, we shouldn't be looking at this regime as the ultimate solution to increasing our humanitarian aid efforts to provide access to medicines, or to addressing disease prevention and health care issues.

[Colette Downie]

That's correct.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

What other solutions would you suggest?That's more or less the question I put to you earlier.

[Colette Downie]

Okay.

[Louise Clément]

Thank you for your question.

I think I listed a few examples in my opening statement. The Government of Canada is involved through CIDA in a wide range of initiatives designed to support health and access to medicines in developing countries. Among others, I mentioned the Africa Health Systems Initiative, the Global Fund to Fight AIDS, TB and Malaria and the GAVI Alliance. These are just a few examples.

CIDA works closely with a great many partners on an international level, including developing countries, to improve health. You are correct in saying that this enormous challenge requires a great effort not only on Canada's part, but on the part of the international community. The leading role taken by Canada at the last summit with respect to the maternal, newborn and child health initiative is another example of efforts in this area.

Perhaps my colleague would like to cite a few more examples.

[The Chair, Conservative, David Sweet]

Thank you, Madam Clément.

Any additional comments will have to wait. We're well over the time.

Thank you very much, Mr. Malo.

Now on to Mr. Lake for seven minutes.

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

Thank you, Mr. Chair.

I thank the witnesses for coming before us today and laying out such a good presentation at the beginning. It's very informative. I listened to my colleague, Mr. Garneau, and he used the word “agonizing”. I thought it a very appropriate word. Those of us on this side of the table would share that we've all been visited by many people advocating on behalf of the people of Africa for help with some very serious issues they have, with regard to not only health but all sorts of things.

You mentioned poverty and all the challenges. Many of us are very aware there's been lots of discussion, with the G-8 and G-20 having been here. Of course, this isn't a left-right issue or a party issue. This is something we all want to try to find an answer to. I'm glad we're having an opportunity to talk about this.

One of the things I think I'm hearing over and over again, a common theme in terms of the discussion, is the theme of potential unintended consequences with the legislation. No one is denying that the legislation is well-intentioned. It sounds as though there are significant concerns with unintended consequences. Could you speak to some of those unintended consequences? Specifically, the first thing that comes to mind is the anti-diversion measures proposed. That would be a good starting point.

[Colette Downie]

I'll just try to go over some of those quickly because there are probably a number. Mostly, though, what they stem from is that ultimately the changes in the bill would expand what is now fairly limited, and limited in design, around getting medicines to developing countries that need them for humanitarian purposes or on certain emergencies. It would broaden that to allow for shipments without any limit in quantity, without any of the markings and other requirements that are currently in CAMR that would allow for the identification of medicines if they happened to come back into Canada accidentally or deliberately.

What you could end up seeing is products diverted either to other countries for commercial reasons, countries like Mexico or Hungary or Poland, or Singapore, where really they're not needed for humanitarian reasons, so for commercial reasons, or you could see the medicines potentially coming back to Canada as well and being indistinguishable from Canadian medicines.

By making the Health Canada review optional, you could also see medicines that haven't been through Health Canada's safety review shipped to other countries, to developing countries, without the same kind of rigorous health and safety regime that Canadians benefit from.

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

It's interesting. Taking the combination of the two issues you're talking about, you could hypothetically see a situation where a drug that hasn't met Canadian requirements for testing actually comes back to Canada as well, right?

[Colette Downie]

That's right.

Brigitte.