Evidence of meeting #40 for Industry, Science and Technology in the 40th Parliament, 3rd session. (The original version is on Parliament’s site, as are the minutes.) The winning word was drugs.
A recording is available from Parliament.
Conservative
The Chair Conservative David Sweet
Actually, I have extended as much leniency as I could. Can you wrap up in 15 seconds?
Edward Ball Eminent Scholar, Professor of International Law, Florida State University College of Law, As an Individual
Yes, let me just make a couple of points. One, there's nothing at all in the TRIPS agreement or the WTO August 30 decision that restricts a licence that would supply multiple destinations on the basis of a single licence. You would also look at the U.S. legislation that allows for government use of patented inventions of a mechanism with which Canada is intimately familiar, which allows the U.S. federal government to use any third-party patent at any time without notification to anyone and without any prior procedure. It is recognized as being compatible with the TRIPS agreement. So there is absolutely nothing in the TRIPS agreement or the August 30 decision or the chairperson's statement that prevents that kind of mechanism
I've otherwise submitted testimony with more details to the committee.
Thank you.
Conservative
The Chair Conservative David Sweet
Thank you, Mr. Abbott.
For the members of the committee and those observing, we're attempting to try to get Mr. Kimani on a separate telephone line and that way have a more clear connection with him. I don't like to do this, but I think for the use of time we're going to go to questions now. Once I'm advised by the technicians that we have him on the phone, we'll allow Mr. Kimani to continue his opening remarks. Again, because of the brevity of time we're going to go with five-minute rounds.
Mr. Garneau.
Liberal
Marc Garneau Liberal Westmount—Ville-Marie, QC
Thank you, Mr. Chair.
First of all, thank you to the witnesses for your presence here this morning. This is a passionately debated issue, and I want to say for the record that I subscribe 100%. I would be out at the front of the parade with respect to any mechanism that will assure that we can get HIV/AIDS, malaria and tuberculosis, and other medicines to those who need them in Africa. I want to make that very, very clear from the beginning.
Ms. Kiddell-Monroe, thank you for your testimony. I'd like to hear from you succinctly in your opinion why Bill C-393will, if not open the flood gates to this medicine that is so needed in countries...why it will solve the problem.
Chair, Universities Allied for Essential Medicines
Bill C-393 actually specifically addresses some of the barriers that we saw in trying to use the legislation.
First of all, in terms of the countries and the notification, the system under the current regime makes a country declare its intention to the WTO to ensure compulsory licence. This is a huge barrier for developing countries when they face repercussions that they have from the U.S. government, from the European Union, and from pharmaceutical companies themselves. Bill C-393 will remove that barrier; that's the first thing.
The second thing is it's a one-licence solution. It simplifies it massively from the situation that we have now. It removes the need for the long period of voluntary licence negotiations. When there is a need there can be simply one licence issued by the Canadian government.
The other issue is that the proposed bill will remove the two-year limit on the compulsory licence and remove the quantity requirements. This is extremely critical, because what happened was that Rwanda made an order for a specific number of people, for a specific number of drugs. After they'd put in that order they realized that they actually needed more. In order for them to increase their order they had to go all the way back through the process from the beginning.
This new piece of legislation would remove that need. It will no longer require countries to be specifically identified; it will enable a licence to be given for an order for drugs for those countries that are listed. So that's how it still makes sure that it only goes to those countries that are listed, that are needed for this.
That will definitely go to the whole issue of creating a market. For a company like Apotex, while they said they would not use the CAMR as it stands again, they would, however, use the reformed CAMR as proposed under Bill C-393 and they deliberately said that they would produce a pediatric version of the Apo-TriAvir for export.
Liberal
Marc Garneau Liberal Westmount—Ville-Marie, QC
Thank you. I only have five minutes, so I'll have to hurry.
Dr. Attaran, you started out by mentioning that one of the main obstacles here is pricing, the fact that it is not financially viable for Canadian generic companies to provide generic drugs. Yet we're hearing a slightly different point of view. Could you expand a little on that argument, please?
Canada Research Chair, Law, Population Health, and Global Development Policy, University of Ottawa, As an Individual
It's very simple. What Apotex did was a stunt for publicity. They announced a price for a triple formulation and were unable to sell it for about two years. They then halved the price—it went from 38¢ a tablet down to 19¢. I may be off by a penny. They halved the price, made a single sale through Rwanda, and then they said they're not going to do this again. That's why it worked the one time.
Now, all the things that Rachel has mentioned, all the desiderata she has for amending the law, I have to say this: they have been tried in other countries. There are over 30 countries that have CAMR-like legislation: all 27 countries of the European Union, plus Norway, plus Switzerland, plus South Korea—I know I'm missing a few--China and India. Over 30 countries have this sort of law and many of them have no expiry date on the compulsory licence. Many of them do have what you'd call a one-licence solution. Nearly all of them don't have a list of countries that are intended recipients or a list of diseases to which it's limited.
And guess what? How many times have those 30-plus laws been used in foreign countries? Total? Zero. Zero invocations for zero treatments for zero patients for zero public health benefit. So this experiment has been tried abroad and I'm sorry to say it doesn't work. I wish it did, but it just doesn't. I know a lot of people will be angry hearing this, but these are the data. Unless you can say the data are wrong, end of story. Honestly.
Liberal
Marc Garneau Liberal Westmount—Ville-Marie, QC
From the information that I've been given, I've been told that it took 68 days to sort out between the company Apotex and the three providers--the brand names, the manufacturers--the licence arrangement. It then took about a year for the first shipment to occur. Then, as you point out, there was a second shipment; it took another year for that to occur. So the argument that's been brought forward was that the brand-name manufacturers were quick to respond, and yet it took a very long time for Apotex to get these drugs to Africa.
Mrs. Kiddell-Monroe, do you have a comment on that?
Chair, Universities Allied for Essential Medicines
They were very quick to respond to the first request for a voluntary licence, which was made quite early in 2005, with a 14-page lawyer's letter back for all the reasons why the companies were not able to accept, to issue a voluntary licence at that moment. Those actual negotiations are behind-the-door negotiations. I was not privy to those negotiations, but they went on for an extremely long period.
After the 68-day period, which I don't actually think is reflecting the true period of the negotiations, what happened then was that Rwanda went through its own systems of having to make a public tender in order to get different quotes from different companies. Apotex's was one of the quotes in there, and many of the delays were on that level.
This is a country's sovereign right to do the tenders process in the right way, which goes to prove that Apotex's activity was absolutely not a stunt, and I take great offence to that comment. This was a genuine effort to get drugs out to people. The reason why it could not be better was because of the restrictions--
Conservative
The Chair Conservative David Sweet
Thank you. We're way over time. I'm sorry that I have to interrupt.
Mr. Dearden, a 30-second response on this subject.
Partner, Gowlings, As an Individual
Because it's important to understand what happened when Apotex responded to Rwanda's notification, I'll give you some dates, members.
July 2007, Rwanda notified the WTO, as it's required to do under the decision.
Apotex applied for a CAMR authorization on September 4, 2007. That authorization was granted two weeks later, September 17, 2007. They had authorization to export 15,600,000 tablets. That authorization was given September 17, 2007. But one year later, September 23, 2008, Apotex ships half of that amount of tablets only. Then they apply for a renewal, so they didn't have to go through it all over again, as Rachel said. They had to apply for a renewal and got it six days later--
Conservative
The Chair Conservative David Sweet
Mr. Dearden, I've given a lot of latitude and time in trying to get a fulsome answer on that. You'll have to add that to the next one. I have to be fair to all members and their capabilities to ask questions.
I also have to go back to Mr. Kimani. We need to ask you if you have a telephone number we can reach you at so we can get a separate connection to you in order to be able to get the audio clearly to us.
Mr. Kimani, can you hear me right now? Is your microphone muted, Mr. Kimani?
His screen is frozen now, so we'll move on to the next questioner and we'll try that again.
Now on to the Bloc.
Mr. Malo, you have five minutes.
Luc Malo Bloc Verchères—Les Patriotes, QC
Thank you, Mr. Chair.
I want to thank the witnesses for joining us.
At our previous meeting, last week, we had with us Dr. Kilby. He told us that, by the end of the year, 5.2 million patients will have been treated, but that it was already clear that the supply from India could not meet those needs. He said that many of his patients will need second-generation medicines because the toxicity level of first-generation medicines is too high. He also told us that in the coming years, he will be able to treat twice as many patients. It's obvious that there won't be enough generic drugs for all those people.
Dr. Attaran, you said in your presentation that our Parliament does not have the power to optimize the current system and make it possible to get medicines to the poorest countries. We are talking about the countries Dr. Kilby mentioned in his presentation.
I ask myself one simple question on the subject. Drugs are needed to meet the needs. If we are unable to provide drugs because of their cost, how can supplies be shipped to those countries? That's the key question people are asking. How can we do more to resolve this problem?
Canada Research Chair, Law, Population Health, and Global Development Policy, University of Ottawa, As an Individual
That is a very good question. We do have a serious problem in the fact that the virus mutates. It's evolution just as Charles Darwin laid it out. After a few years, first-line medicines are no longer effective. We now need second-line medicines. Fortunately, they are available in countries like India, for instance. India is actually the largest supplier of second-line drugs. The fact that Canada cannot provide those medications doesn't mean they're unavailable. They are available elsewhere.
I believe that you asked what we can do here, in Canada. I already mentioned that there are serious problems with CIDA, which is not a very effective donor, among other things. Even if we are unable to supply the required drugs, we can still provide money, technical assistance, and so on. I'll give you one example. Since counterfeit medications can cause death, a child with malaria who is given counterfeit tablets will die because the tablets don't actually contain any medication. We can provide technical support to help avoid similar outcomes in countries that don't have laboratories for drug testing.
Bloc
Luc Malo Bloc Verchères—Les Patriotes, QC
Last week, Dr. Kilby told us that Indian regulations on patented medicines prohibit the shipping of second-line generic medicines. Yet, today, you are saying—
Canada Research Chair, Law, Population Health, and Global Development Policy, University of Ottawa, As an Individual
That is totally false. India has legislation that is almost identical to Canada's Access to Medicines Regime. Pardon me, but I will have to explain this in English.
Canada Research Chair, Law, Population Health, and Global Development Policy, University of Ottawa, As an Individual
I cannot emphasize this point enough. There are over 30 countries with CAMR-like laws. In the wake of the WTO decision, Canada was the second country to pass a law. Norway was first, we were second, but then about 30 more did, including all 27 countries of the EU. If none of those other countries has succeeded in making this type of law work, that should tell us something. But bear in mind that because those other countries do have similar laws and their generics are less expensive than Canada's, it would be those laws, if ever they were useful, that would be used first.
Look, it's just an act of tremendous hubris to think that Canada is the solution to the world—we're not. We're not the solution to this particular problem. There are areas where we can be a solution, and by God we should be, but this is not one of them, I'm sorry to say.
Conservative
The Chair Conservative David Sweet
Thank you, Mr. Attaran.
Thank you, Mr. Malo.
We're now on to Mr. Lake, for five minutes.
Conservative
Mike Lake Conservative Edmonton—Mill Woods—Beaumont, AB
Thank you, Mr. Chair.
Thank you to the witnesses for coming today.
Ms. Kiddell-Monroe, while you and I may disagree on some aspects of this, I definitely appreciate the passion that you have for the issue. It's clear that you have a tremendous passion. And around this table--and from what Mr. Garneau said as well--if the question is do we want to help the people of Africa who are suffering, absolutely, I think that you'd find agreement all around the table and in this room. The question we're trying to answer today is does Bill C-393 actually accomplish this, or are there other things that are working or that we should be focusing on to accomplish this?
I go back to Mr. Kilby's testimony before the committee here the other day, when he was talking about the numbers of people who are receiving antiretroviral drugs. He talked about the numbers in 2003 and he said that 400,000 were receiving those drugs; by 2005 we got up to 1.5 million; and by the end of 2010 we expect to get to 5.2 million people being treated. That seems like a significant number. In fact Mr. Kilby, to quote him from the meeting, said:
Essentially a comprehensive model for care many believed could never be built emerged in a few short years. What has been accomplished is nothing short of a miracle, 5.2 million people on treatment by 2010.
Do you agree with what Mr. Kilby had to say regarding the progress?
Chair, Universities Allied for Essential Medicines
Yes, I absolutely do, and I think that is because of the entrance of generic competition into the market and bringing down the prices. That's exactly why that has been accomplished. We also have to remember there are still nine million people who have HIV/AIDS who do not have access to treatment. Those people are desperately in need. There is still a huge need, and the second-line, third-line drug issue is a big issue.
India is not going to be the solution to that. One of the big reasons is that many of those drugs are under patent in India. Due to its compliance with the WTO from the first of January 2005, it can no longer just produce many of those drugs under generic versions, so its prices will be higher.
Canada has a role to play in order to bring another player into the market, have their generic companies.... When Apotex came into the market, it forced Indian companies to go and make sure that their drugs were of adequate quality and get them pre-qualified with the WHO program. This was a hugely important aspect of what Apotex managed to do.
If the limitations are taken off, as would be the case under Bill C-393, we would be able to provide another player in the market, which would encourage competition.
Conservative
Mike Lake Conservative Edmonton—Mill Woods—Beaumont, AB
So in terms of what Canada can do, you talked about that, and one thing that we know from previous testimony, Mr. Attaran's testimony today, is that other countries are producing those drugs and making them available much more cheaply than Canada can.
What we do know is working is the funding of the global fund now. The government just announced a third replenishment of $540 million from 2011 to 2013. That's a 20% increase from the last replenishment here in Canada, and I think $1.5 billion since its inception in 2002--very, very significant.
Speaking to what Canada can do to have a significant impact, not so concerned with where the drugs are coming from or whether they're coming through CAMR or through some other mechanism, I would think that we can agree that the most important aspect of this is that drugs are actually being received by the people who need them, to the tune of over ten times as many as were being treated in 2003.
Chair, Universities Allied for Essential Medicines
The question is the sustainability of that increase, and if we need new lines of drugs that are being protected under patents—and they're not being produced all over the place, as seems to be implied at the moment, for distribution—then the problem is not going to be improved. Of course, while we have the first line, they can use them.
The issue about other countries having this legislation in place is that many of them have not tried to use their August 30 legislation. One of the reasons was that they were looking to Canada to see how Canada would behave, how Canada would be able to make it work, and many countries are still waiting to see that.
There will be new discussions at the WTO about the August 30 decision and why it's not working, and how to make it a functional thing. I believe we need to have more solutions on how to get the correct medicines to people. The second line of the AIDS crisis is showing that.