Industry Committee on Oct. 21st, 2010

[The Chair, Conservative, David Sweet]

Mr. Elliott, just briefly, could you clarify? In the federal government we have so many acronyms, and I'm curious as to whether everybody's being respectfully silent and wondering what MSF is.

[Richard Elliott]

Oh, I'm sorry, it's Médecins Sans Frontières, Doctors Without Borders.

So in order for Apotex to then move forward to be in a position, legally, to sell it to MSF, they needed to be able to go to the brand name companies in Canada that hold the patents on those three drugs and say to them, “We would like you to voluntarily give us a licence to supply x quantity of this drug to this particular country”. They then are required to negotiate for 30 days. If they cannot agree on the terms of a voluntary licence, then Apotex could apply to the Commissioner of Patents for a compulsory licence, and the commissioner, then, would order them to pay the royalty according to the formula in the current law.

But that 30-day window is really part of the problem, because you have to start that 30-day clock ticking if you want to run out the 30 days so that you're in a position to get a compulsory licence. That clock does not start ticking until you tell the brand-name company, “This is the specific country, and this is the quantity of the drug”. So if you can't get a country to come forward ahead of time, you're stuck—

[Francis Scarpaleggia, Liberal, Lac-Saint-Louis, QC]

So you're saying it's very difficult to get the governments in some countries to come forward?

[Richard Elliott]

In some it is. MSF tried for 18 months--and it has a presence in various countries--and it ultimately abandoned the effort because it could not get a country to come forward.

[Francis Scarpaleggia, Liberal, Lac-Saint-Louis, QC]

You gave all the reasons why this bill is actually in the interests of the brand-name pharmaceuticals: they would get royalties; they wouldn't be cannibalizing their own markets, and so on. So why, in your view, are they so against the bill? What is the main reason? If it's actually a good business proposition for them, what's the sticking point?

[Richard Elliott]

Can I be frank?

[Francis Scarpaleggia, Liberal, Lac-Saint-Louis, QC]

Yes, that's what you're here to be--frank.

[Richard Elliott]

On one level it's greed--to be honest--and on another level it's a larger political agenda. And the larger political agenda, which I think has been on full display for decades now, has been that they want to impose on a global basis ever more stringent intellectual property rules, because that's in their interests as monopolists. I mean, that's in the nature of the scorpion that stings the frog carrying him across the river, right? Their interest is to protect a monopoly system as much as possible. And that's why they have first-world intellectual property standards globalized through the WTO.

The pharmaceutical industry and the entertainment industry were the major proponents of this agreement. That's very clear in the historical record. I'm not making that up. And they don't like the flexibilities that are in that regime, things like compulsory licensing, because if you're a patent holder, you're going to have a knee-jerk reaction against anything that allows your patent to be overridden, even if it's for a limited purpose. But WTO law is very clear that that is, in fact, part of striking the balance between protecting intellectual property and ensuring access.

That doesn't mean that they like it, so they will oppose--and they have opposed--every time developing countries either contemplate using compulsory licensing or issue compulsory licensing. And there is extraordinarily strong push-back: litigation, threats of trade sanctions, threats to withdraw the registration of new medicines—I'm talking about Thailand, South Africa, Brazil, and so on—over and over again, which is partly why, I think, countries have been reluctant to come forward, especially if what you're offering them is a flawed system that doesn't guarantee they're even going to get a medicine at the end of the day. Why would you stick your neck out and run the risk of this kind of retaliation when you're not expecting—

[Francis Scarpaleggia, Liberal, Lac-Saint-Louis, QC]

I don't know if there's time left for Mr. Rota.

[The Chair, Conservative, David Sweet]

Officially there's not, but the Conservative Party did go over quite a bit.

So, Mr. Rota, do you have a brief question we can get a brief answer to?

[Anthony Rota, Liberal, Nipissing—Timiskaming, ON]

Thank you, Mr. Chair.

I hope this is a quick question, and it actually ties into what Mr. Scarpaleggia was talking about.

The argument I've heard, as well, is that it's been only six years since CAMR has been implemented, and some would say it really hasn't had a chance to take full effect and it will probably start working once countries like India pull aside.

India, with the changes, with the WTO restrictions that have been put on it, or with the agreements that have been put in place, will likely pull aside. Realistically, can you think of any other countries that would take India's place? Will the changes prevent some of the problems that are occurring now, such as drugs not coming?

What concerns me is that we put the changes in place and nothing happens and we just keep going the way we are. I don't think that's the intent. What we want to see is actual implementation and actual availability of the medication.

[Richard Elliott]

Definitely. In our assessment, and in the assessment of those who've tried to use the current system and the experts who have looked at it, if we make these changes, we dramatically increase the chances of it being used again to get medicines out the door.

I don't think it's premature, after six years, and I don't know how many avoidable deaths, to say the system is not working. We have to accept the reality that one drug to one country in six years is not what was promised; it's not what it should be.

This was supposed to be an “expeditious solution”: those are the words of the WTO members themselves. That's what they wanted to come up with. We haven't got it there, but we could.

[The Chair, Conservative, David Sweet]

Now on to Mr. Lake, for five minutes.

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

I want to follow up again, if I could, on the last line of questioning.

Mr. Kilby, I want to come to you with a similar question to what I asked Mr. Elliott. But I first want to lead in by saying that your testimony and what you've talked about with respect to building capacity and the things your organization is doing sound phenomenal. It sounds like exactly what is needed, based on conversations I've had with people who really care about this issue.

Let's be honest: we all want the same thing. We're sitting around this table and we have witnesses coming and arguing both sides of a piece of proposed legislation and we all want the same thing. We all want more help going to people in Africa to solve this significant problem, the number of people who are dying, not only of AIDS, but of all sorts of things that are completely preventable. People dying of diarrhea is completely unacceptable. We need to take steps to address those things.

Could you lead off in that context? Again, commenting on the numbers: 400,000 in 2003 to 5.2 million by the end of 2010 is significant progress.

We're obviously using other means than CAMR to make that progress. We heard in the testimony at the previous meeting that there are several things that are working, and that is a big reason CAMR is simply not being used. It's not necessarily that it's not working, it's just not being used because there are other alternatives.

Again, what was the number of people who are not getting treatment who need to be getting treatment? Can you remind me?

[Dr. Don Kilby]

Double.

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

Double the 5.2 million. Are you saying double the number are not being treated, or is double the total number of people who need to be treated?

[Dr. Don Kilby]

Who need to be treated.

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

So we need to double the 5.2 million.

With the momentum we have, it seems if we continue on that track we will get there soon; it seems as though we will. There's been a tripling from 2003 to 2005, and there's been another tripling from 2005 to 2010.

[Dr. Don Kilby]

But we have a few problems now. One, again, is the issue that we're not funding the global fund today as we funded it a year ago in order to do this work.

With less funding to do double the work...first of all, that's not going to happen. The only way that countries that contribute to these multilateral agreements through the global fund are going to even be able to get value for their investments--because they will be asked to invest again in the global fund, especially as we have more and more people who are clamouring to be on treatment and who are not going to be able to access treatment.... The cost to our government and other governments around the world is going to be even greater, especially if we are prepared to pay 10, 20, or 30 times more in terms of the drug costs.

The human resources costs, the procurement costs, the transportation costs, and all the rest of it, we can keep in check. The one thing we're not going to be able to keep in check if we don't come up with some sort of easy procurement solution for these drugs to be available cheaper.... At the end of the day, we either give up and say this the best the world can do, or, especially if we say we've made a commitment to 5.2 million.... We know today that with the molecule available out of India, which most of these people are on, 30% of them have to come off that molecule within two years because the toxicities are too great for them to continue. The pain they get in their legs and their hands is too great. We won't talk about them getting fat atrophy and their faces looking wasted and everything else; we're just going to talk about pain.

For that reason alone, when we move to the next level, to that second line, if we can't get that second line to them at the same price we're getting the first line to them, or at least at a comparable price, we're going to have to back away from that commitment we're already made to those 5.2 million people, and say, “You know what, you were on therapy, but we can only afford to have three million in the world on therapy because the costs are too prohibitive”.

And with the global fund--and, Pep Pharm, because the Americans have come back as well, in terms of their commitments--we just can't afford it.

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

The thing that concerns me is that while we want the same thing, we recognize there are issues. I think the issues you're talking about, the things we need to address, we can probably have a common conversation around, with agreement on many things. What we've heard from the experts—and keep in mind that the government experts who were before us at the previous meeting aren't partisan experts, they were people who were the experts under the Liberal government and they're the same people who are the experts under the Conservative government—from four different departments was that they were adamantly opposed to this bill, saying the bill would accomplish virtually nothing and yet would have untold unintended consequences. And that's very concerning to me as a member of Parliament.

Again I come back and I'd just like you to comment if you could on the health question I asked. Does it not concern you that under C-393 we would have a regime whereby drugs are being approved by a country in Africa and having no approval process subject to the same considerations that a Canadian using those same drugs would be subject to?

[The Chair, Conservative, David Sweet]

If you'd like to answer that question--

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

I'd like that question to go to Mr. Kilby.

[The Chair, Conservative, David Sweet]

Okay.

Mr. Kilby, you can address that in your closing remarks. I'm trying to get through so I can give you both about two minutes for closing remarks.

Mr. Cardin, you have five minutes.

[Serge Cardin, Bloc, Sherbrooke, QC]

Thank you, Mr. Chair.

Good afternoon, gentlemen.

I believe there is a significant issue in terms of funding. Does the $13 billion you talked about in the beginning represent the total sum for AIDS or is it for all diseases, in terms of health care?

[Dr. Don Kilby]

That amount is for AIDS, malaria and tuberculosis.