Industry Committee on Oct. 21st, 2010

[Peter Braid, Conservative, Kitchener—Waterloo, ON]

Thank you, Mr. Chair.

I just want to continue some of the threads of our conversation here.

Mr. Elliot, I realize we're dealing with Africa, but I want to come back to India just briefly. You mention that patent law in India is evolving. Does India have a regime similar to CAMR today, and if not, will it need one as that patent law evolves?

[Richard Elliott]

Thank you. That's an excellent question.

Because India now grants patents on pharmaceutical products--where it did not before 2005--in order to produce and export a generic version of a drug, you would need a mechanism like CAMR. In 2005, when India made the changes to its Patents Act to introduce patents on products, it also included one paragraph in the Indian Patents Act, section 92A, that is basically supposed to be the equivalent of CAMR under Indian law.

It's interesting, because that provision has not yet been tested and it's a mirror image of the Canadian problem. With CAMR we have far too much red tape. Things are just gummed up with unnecessary restrictions and laborious processes, and so on.

The unfortunate deficiency of the Indian legislation, in my view, is that it doesn't provide enough detail. You have one paragraph that doesn't actually provide the operational guidance that's needed. So, for example, where the Canadian legislation, to its credit, does define very clearly what the royalties are that have to be paid by a generic company to a brand-name company in the event of a licence being issued, which is a hugely important feature for the generic companies because they said all along that they need certainty about what the cost is going to be at the end, which makes sense from a business perspective, the Indian legislation has no such specificity about what the royalty is that has to be paid. You can be sure that the first time someone tries to use the Indian legislation it's going to be months or years of litigation in the Indian courts, arguing over what's the appropriate royalty that has to be paid here. That's one of the reasons there's this big question mark over whether India is going to be able to continue supplying generics to the developing world.

So, yes, it's there on the books, but I think it suffers from deficiencies just like the Canadian one does, although a different deficiency.

[Peter Braid, Conservative, Kitchener—Waterloo, ON]

Very good.

Now a question about health reviews: on the HIV/AIDS medications that are working on the ground today in treating those 5.2 million people, through which health review mechanism were those medications tested and ensured that they had adequate efficacy and were safe? Were they through the country mechanisms, or the World Health Organization mechanism that you mentioned, Mr. Elliott?

[Richard Elliott]

It would depend on the country, but most of the drugs, most of the generics, for example, that are being used to treat people are being WHO pre-qualified. That's why WHO set up that mechanism, and most developing countries that are purchasing medicines are requiring that there be that WHO pre-qualification for any medicines they purchase.

[Peter Braid, Conservative, Kitchener—Waterloo, ON]

Dr. Kilby, I just want to move on to another topic if I could. You addressed an earlier question concerning the possibility of drugs in larger quantities being shipped to a developing country and coming back. In your mind, you see that as a very low risk. I did hear you say, though, that one possibility or concern was drugs leaking across borders on the African continent, for example. So could you just tell us a bit more about that and why you're concerned about that? Ultimately, the purpose of this mechanism and these drugs is for humanitarian purposes and not for commercial purposes or to be diverted. So could you speak a little about that?

[Dr. Don Kilby]

The reality is that the borders are a lot more porous than the borders we have here, and people do cross borders all the time.

I know when we work, for instance, in Benin, and we offer services to people from Benin, there are lineups of people who come from Togo. They cross the border and come to get free medication, free dental care, or whatever we have to offer. That's the kind of porousness that's going to happen. And it happens already today. One country may have a procurement process in place, and even though the drugs technically are destined to the people of that country, there are people who filter through that and get medication, for instance, in Kenya and get back into Uganda, where there's a shortage of supply.

[Peter Braid, Conservative, Kitchener—Waterloo, ON]

So is it more a case of people travelling to where the medications are being administered, as opposed to the medications being diverted? That would be the concern.

[Dr. Don Kilby]

Exactly.

[The Chair, Conservative, David Sweet]

You're virtually out of time.

Now on to Monsieur Malo.

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

Thank you, Mr. Chair.

Dr. Kilby, you said earlier that the funds available for buying medicines in the affected areas, by which I mean developing countries, come from two different sources. In fact, you mentioned two, but perhaps there are more than two. I would like to get the big picture. Right now, how much money is on the table from the various sources that are available to purchase antiretroviral drugs for the countries you work in?

[Dr. Don Kilby]

What happened in Africa specifically is that the continent has been divided, meaning that the countries who make multilateral donations are responsible for some countries, or parts of countries, and the Americans are responsible for other parts of the countries. So, where we are working, the programs are sometimes subsidized by the Americans and they are the ones who buy the drugs, and, other times, the drugs are bought through programs under UNAIDS and the Global Fund to Fight AIDS, Tuberculosis and Malaria.

I don't know anymore what the total sum is and how many billions of dollars we are talking about. I think we are at, for the two—

[Richard Elliott]

The Global Fund is around... It depends on each country's contribution.

[Dr. Don Kilby]

The amounts have gone down this year. We were aiming for about $10 billion. The Americans put in $3 billion. So we're talking about a market of around $13 billion today.

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

Is the $13 billion used to buy drugs only?

[Dr. Don Kilby]

It is for the whole infrastructure development program and for drugs. It is for everything.

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

How much of that goes to buying medicines?

[Dr. Don Kilby]

I don't know how much.

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

As Mr. Braid said earlier—and Mr. Masse mentioned it in his question—there is the whole issue of traceability. And this does not necessarily have to do with whether the medication will be returned, but whether it will be distributed elsewhere for commercial purposes. So a drug diversion problem would arise. When the officials appeared before us last week, that is one of the aspects they drew our attention to, saying that Bill C-393 reduces traceability, or does not allow for the traceability of drugs in order to ensure that they are really going where they are supposed to.

Mr. Elliott, in your presentation, you were challenging some of the negative arguments against Bill C-393 made by the officials last week. In your opinion, their warnings to us were not justified. Could you perhaps provide more details on the topic? Could you explain why, in your opinion, officials responsible for the smooth operation of Canada's Access to Medicines Regime, that is the officials responsible for making sure that vulnerable populations have access to drugs, would want to put up roadblocks, so to speak? Why would they be against improving the program, which is designed to ensure that vulnerable populations get the help they need?

[Dr. Don Kilby]

First, Canada is not facing any problems because of a plan that does not work. Actually, if we had a plan that did not work, there would be no risk of diversion or of other problems surfacing. But if we want a plan that works better in terms of drug supply, we will have to face some risks. No one can say that we won't be facing any risks. The officials' job is to make you see the potential risks Canada would be exposed to if we were ever to review the legislation in order to make it easier to supply medicines.

I feel they're doing a good job. Their job is to tell you where the risks lie. But I am not sure whether these fears will turn out to be true. However, I am sure that, if people around the world stayed home without doing anything just to avoid taking risks, we would be in big trouble. Anyway, that's not the main goal of Canada's Access to Medicines Regime.

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

Could you tell us your opinion, please?

[The Chair, Conservative, David Sweet]

Monsieur Malo, we're actually way over time. I was just allowing Mr. Kilby to finish the answer to that question.

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

I am simply asking him to give us his opinion.

[The Chair, Conservative, David Sweet]

We'll have to wait until next time.

Thank you, Mr. Kilby.

Now to Mr. Van Kesteren for five minutes.

[Dave Van Kesteren, Conservative, Chatham-Kent—Essex, ON]

Thank you, Mr. Chair, and thank you both for coming here this morning.

Mr. Elliott, I want to congratulate you for your obvious passion. You've obviously done much work here, and I think it must be very frustrating for you to see all these lives being lost. I wanted to make mention of that.

Did you say there were 8,000 people a day who die?

[Richard Elliott]

Yes.