Evidence of meeting #55 for Industry, Science and Technology in the 39th Parliament, 1st Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was drugs.
A recording is available from Parliament.
5:25 p.m.
President, Canada's Research-Based Pharmaceutical Companies (Rx&D)
Mr. Arthur, I think you actually highlighted a number of the problems we're talking about. One of the things we try to say is that there are many ways we should try to find a solution. There's not one solution; there are many solutions. If we try to think there's one panacea that's going to fix everything, we're wrong. So whether it's preferential prices, cost-free generics, it's all part of that question.
There's another more fundamental question about clinics and health care and transportation. I think John Kelsall is the president of Health Partners International Canada. He came here last week and talked about this as actually even being a transition. What we should be doing is trying to train and to help people develop their own manufacturing capabilities overseas, to work on their health care system, etc.
So I'm actually thinking there are many solutions and we should build on each and every one of them. We shouldn't be looking for just one answer.
5:25 p.m.
Conservative
5:25 p.m.
Independent
5:25 p.m.
Conservative
The Chair Conservative James Rajotte
We're at the end, so I will have a few minutes for a few questions for the chair.
First of all, I want to thank you all for coming in today and for discussing this issue in this manner.
I do want to touch upon a number of issues.
First of all, in Mr. Alton's presentation, he talks about the forecasting and duration of a licence. I'm assuming the generics are supportive of what Mr. Alton is recommending in both of those things, with respect to removing the forecasting requirement and that CAMR should not prescribe a specific duration of a licence.
I want to get Mr. Williams or Mr. McCool to respond on the forecasting and duration of a licence.
5:25 p.m.
Vice-President, Corporate Affairs, Eli Lilly Canada Inc.; Canada's Research-Based Pharmaceutical Companies (Rx&D)
I think the duration of a licence is reasonably generous. It's two years with a two-year renewal, so it's actually a four-year licence. I think part of the rationale behind that is this. If prices drop, if new technology comes on that's a little better, do you really want to tie governments into unending contracts without a way out? I just think there's probably a process that needs to be in place that respects the legislation that's been passed.
5:25 p.m.
Vice-President, Corporate Affairs, Eli Lilly Canada Inc.; Canada's Research-Based Pharmaceutical Companies (Rx&D)
Forecasting is a challenge because they don't know how many people they're going to treat in some of those countries. It's all dependent on the number of health care centres and nurses, on being able to get into rural communities, the infrastructure, transportation, and things like that. I don't know how you forecast that in sub-Saharan Africa, I really don't.
5:25 p.m.
Conservative
The Chair Conservative James Rajotte
Thank you.
I also want to get your response in the generic presentation. In the additional information they've provided, they said that with the WTO decision, they do have to satisfy themselves that the importing countries made the required notification of TRIPS, that they needed a product. I think the generics are arguing that this notification can be met in a much easier and simpler form than what has happened under CAMR now. If there were some form of notification, but if it were simplified, would you be in favour of that, or do you believe the notification in CAMR is the minimum standard?
5:25 p.m.
Vice-President, Corporate Affairs, Eli Lilly Canada Inc.; Canada's Research-Based Pharmaceutical Companies (Rx&D)
I think it's pretty minimal notification, to be honest with you.
5:25 p.m.
Conservative
The Chair Conservative James Rajotte
It's a minimal standard.
Mr. Alton, do you have a position on that?
5:25 p.m.
Vice-President, Corporate Affairs, Eli Lilly Canada Inc.; Canada's Research-Based Pharmaceutical Companies (Rx&D)
Yes, and I've stated before that I think the notification requirement is very important. I don't think it imposes an undue burden.
5:25 p.m.
Conservative
5:25 p.m.
Senior Vice-President and General Counsel, Gilead Sciences Inc.
No, I think that's critical.
5:25 p.m.
Conservative
The Chair Conservative James Rajotte
Okay.
With my third question, I'm try to clear this up. There are a lot of people who say this legislation doesn't work, it's broken, it's a disaster, it's just terrible. Yet one of the challenges for the committee is we don't actually have very many case studies where we can say it has not clearly worked in this case or that case. My understanding from the officials we had here at the first session is we have two cases that we can actually look at. One case is public; the other case is not.
I want to try to understand for myself what happened or did not happen in the case with respect to Apotex and the drug. My understanding is that it was actually three patent holders, but Mr. Kay mentioned it was four patent holders. Based on the research I've been given, my understanding is that Apotex submitted the product for Health Canada approval under CAMR in December 2005. The approval was granted in June 2006. In August 2006 the drug received pre-qualification status from the WHO. Apotex began discussions with the drug's patent holders in June 2006, but because of the complexity of the process, nothing has moved since.
I want to try to understand what is meant by the complexity of the process. On reading this background, which was provided by the researchers, it seems to me the process was moving along and then it stopped.
So, Mr. Kay, explain to me why the process stopped.
5:30 p.m.
President and Chief Executive Officer, Apotex Inc.; Canadian Generic Pharmaceutical Association
It's because the country that MSF was buying the products for did not want to be identified. It's that simple.
5:30 p.m.
Conservative
5:30 p.m.
President and Chief Executive Officer, Apotex Inc.; Canadian Generic Pharmaceutical Association
That is correct.
5:30 p.m.
Conservative
5:30 p.m.
President, Canada's Research-Based Pharmaceutical Companies (Rx&D)
As I've mentioned several times, there are four basic criteria that need to be responded to in the first phase and in the second phase. We believe they are quite straightforward.
My understanding is that in the second phase, if the first 30 days don't work, there would be a movement fairly quickly to compulsory licensing, if all criteria were completed. I don't know why that stage still hasn't been tested.
5:30 p.m.
Conservative
The Chair Conservative James Rajotte
Do you agree with what Mr. Kay said that the reason the process stopped is because the country did not want to be identified? Is it true or is it not true?
5:30 p.m.
President, Canada's Research-Based Pharmaceutical Companies (Rx&D)
I cannot determine the reason that Apotex didn't continue.
5:30 p.m.
Conservative
The Chair Conservative James Rajotte
He's saying this is the reason that it did not continue. I don't know. It's why I'm asking.
5:30 p.m.
Vice-President, Corporate Affairs, Eli Lilly Canada Inc.; Canada's Research-Based Pharmaceutical Companies (Rx&D)
We wouldn't know the answer to that either.
5:30 p.m.
Conservative
The Chair Conservative James Rajotte
It seems to me that we've hit an impasse where if no country actually wants to be identified, this legislation will never work. What I'm looking for as the chair, and I think what all members are looking for, is a process that will work here.
The NGOs are clearly saying the NGOs should be allowed to purchase the medicine, and then they can provide it. I know the generics would be in favour of that.
Mr. Alton and Mr. Williams, do you want to respond?
