Industry Committee on April 16th, 2007

[Douglas George]

If I could address that, the only duplication in the European Union is the Netherlands, and I believe they moved before the EU as a whole did. The EU represents 27 countries; Switzerland and Norway are outside the EU. Norway was in fact the very first to implement this, and they beat us by a fairly short period.

There are a number of us who've implemented this in different ways, but it's interesting to note that we're all running into the same issue of why no one is taking it up. Canada has been very active in explaining to other WTO members what we were intending to do, what we were doing and what we've done, and in explaining to them the review process and how they could access our system. Other countries, as they've implemented this, have done it. We've worked with some of them, including the EU, to explain how we implemented our system.

All I can say, as Doug Clark pointed out, is that as yet, no one has accessed this system. When we were negotiating the amendment, some countries indicated they were not going to amend their own domestic legislation to take advantage of it when it was under waiver because it was perceived as a temporary instrument—although some waivers have lasted for a very long time. So the amendment, once it comes into effect, will give them the assurance that this is a permanent amendment to the WTO, and it might at least remove the perception that was causing some of the developing countries not to implement it.

[Ken Boshcoff, Liberal, Thunder Bay—Rainy River, ON]

Is there a technical or a procedural issue in the process, in which you have an international conference where the least developed countries are saying, we need your help? Does someone from Canada actually go to that person and say, we can do this for you, or is there a gap in how that's communicated, or in making these connections?

Are we talking of some simple human dynamics here?

[Douglas George]

As we pointed out, we've engaged in outreach on a number of occasions. Mr. Clark and I made a presentation of some length to the African group in the WTO, but that's just one of many instances where we've been working with the groups.

I think maybe some of my colleagues could detail some of the others.

[Ken Boshcoff, Liberal, Thunder Bay—Rainy River, ON]

Perhaps you could add something on the health infrastructure on the receiving end also, please.

[Christopher Armstrong]

Thank you for the question.

There is no shortage of health fora around the world, where these things are brought up. Developing countries come together with donors, UN agencies, and other multilateral bodies, such as the global fund, to discuss health issues.

There's absolutely no shortage in Canada. As a participant in global health issues, I wouldn't say we're present at every single health conference. But we are there when it's relevant and when we feel it's an important issue. Absolutely this is an issue that we raise and discuss on every occasion when it makes the most sense. We are doing this from international AIDS conferences to high level fora on health.

A colleague of mine is going to a meeting on access to medicines later this week in the United Kingdom.

We're supporting a meeting here in Ottawa, which my colleague Doug Clark spoke about, that's bringing developing countries together with government officials, NGOs, and members of industry to talk specifically about access to medicines and to look at some of the challenges faced by both developing countries and industry in accomplishing this.

One of the key issues, which we need to understand, is that the Government of Canada is not providing the medicines. Canada's manufacturers and pharmaceutical industry will ultimately be providing the medicines around the world. Efforts are called for to bring these together as well.

[The Chair, Conservative, James Rajotte]

Thank you.

Thank you, Mr. Boshcoff.

We'll go to Mr. Shipley.

[Bev Shipley, Conservative, Lambton—Kent—Middlesex, ON]

Thank you.

I appreciate that you came out today. It was interesting, and obviously there are sincere concerns around the table. Basically I would phrase it by asking, why hasn't a drug moved yet? This is the question that shows up on the floor.

We have a number of ministries sitting here. As I listen to some of the discussion, I wonder, is there a concern about the rollover, or the lack of communications between the responsibility and involvement of each of the ministries? Do you see that in any way? For some reason, we have a process problem that doesn't seem to get resolved.

Then I'll have a follow-up question.

[David Lee]

When the legislation first came into place and we got all the way down to making regulations, we had some early discussions with the Canadian Generic Pharmaceutical Association. We had some of the generics in, and we figured that we needed a good end-to-end account of how you apply through the various parts of the process, because there are some complications there.

We made a description, along with the person over at the Commissioner of Patents office. We all sat together and figured out how to get from one end to the other. We were called on to do that on a number of occasions.

It still remains complicated whenever you put drugs together with patents. These are two very complicated areas to explain. It has certainly been a big challenge to explain exactly how the whole system works. Usually people have the patience to do it. We sit down together with our colleagues from Industry Canada, and so on.

We don't get to talk very often to our colleagues in other regulatory jurisdictions--for example, in Africa. We have had some occasions to sit down together. I know my health minister has talked to colleagues in Tanzania and Kenya. We've been trying to do some outreach with colleagues who are regulators there, but sometimes the way they communicate or not with their patent office is questionable.

How we all sit and talk together really is the issue. In our departments we try to keep some rapport, but it is complicated.

[Bev Shipley, Conservative, Lambton—Kent—Middlesex, ON]

We'll take that as sort of a group answer, perhaps because we don't have the time in my five minutes.

When one of you was speaking French, you mentioned that you've been working with the groups in Africa.

Mr. Armstrong, you also talked about it in terms of CIDA, and that's a bigger issue. So are you talking to the nations?

[David Lee]

Yes, at least to our regulatory counterparts there, to the extent that they represent their countries.

[Bev Shipley, Conservative, Lambton—Kent—Middlesex, ON]

Those are the representatives who represent their countries. If they were to make the request to Canada, are you talking to the right departments?

[David Lee]

Usually it would be the department of health there or some other representative like that, yes.

[Bev Shipley, Conservative, Lambton—Kent—Middlesex, ON]

So then why aren't they asking?

[David Lee]

That I can't.... That you would have to ask them. I don't have evidence to offer you on that.

[Bev Shipley, Conservative, Lambton—Kent—Middlesex, ON]

Okay.

We've mentioned several other countries besides Canada—China, India, the United States, the EU--that have medicine regimes similar to what we're experiencing. Are they experiencing the same challenges? Are they doing the same discussions as Canada is with the other countries?

[David Lee]

We have on a number of occasions spoken with colleagues. For example, we've made presentations along with the EMEA, and we've panelled together with the FDA, the WHO. We're all sitting in the same rooms with colleagues from Africa and other places that could potentially use the system. We make joint presentations. The same issue comes up for all of us--namely, that drugs are not moving under the various programs.

[Bev Shipley, Conservative, Lambton—Kent—Middlesex, ON]

Do they have drugs moving? Have they moved any drugs either?

[David Lee]

Every indication I've had from them is that they have the same issue we do: they're not moving.

[Bev Shipley, Conservative, Lambton—Kent—Middlesex, ON]

How does CAMR compare with legislation in other countries? Is ours similar?

[Douglas Clark]

It's similar in many respects. There's a slide in the presentation I gave at the start that breaks it down. The fundamentals are pretty much the same. Other people may disagree with that assessment; that's our assessment. But there are some notable differences.

[David Lee]

No one is notified under the WTO process internationally. That's part of the application they would have to make here. No country has actually gone through that yet. We have to wait for that as well.

[Douglas Clark]

That's a condition precedent to anybody exporting under any of the regimes. It's a requirement of the WTO waiver.

[The Chair, Conservative, James Rajotte]

Mr. Shipley, you're out of time.

We'll move on to Monsieur André.

[Guy André, Bloc, Berthier—Maskinongé, QC]

Good day. I'm delighted to be here this afternoon.

HIV/AIDS is a serious problem. I've travelled to Africa several times and, having also read up on the subject, I've observed that this epidemic affects a number of countries. We need to move in another very clear direction in the near future because more and more people are dying from HIV/AIDS. We have the statistics to prove it.

However, in terms of Canada's level of supply and the policies governing the drugs used to treat AIDS, do countries -- you mentioned Sierra Leone, Burkina Faso and some of the other least developed countries in Africa - know that they can have access to these pharmaceutical products? Do they have the means to obtain these pharmaceuticals? As you recall, they must pay royalties, which can range anywhere from .02% to 4%, depending on the country. Can they afford these royalties?

On another note, what is the nature of your relationship with CIDA? How do you work with this agency that currently carries out field operations in Africa and in a number of countries? How do you work with these countries in an effort to meet the needs expressed? We talk about cities, but we can't lose sight of people who live in remote rural areas, people who need information and ways of preventing and treating diseases.

[Douglas Clark]

Regarding information requirements, as was just mentioned, all of my colleagues here have had opportunities to present and explain the Canadian regime to our counterparts in other countries, particularly to African nations.

Quite simply, I think the best approach would be to circulate the list, in both languages, of all international meetings in which we have taken part to date and at which we attempted to share this information with our counterparts.

Once these discussions have occurred, I don't know if these individuals return to their county and disseminate...