Health Committee on April 15th, 2010

[Anita Neville, Liberal, Winnipeg South Centre, MB]

Does anyone else want to comment on the political aspects of this, or do you all want to stay away from it?

Let me go back to my question, Ms. Medwick.

As my colleague has indicated, I fully recognize that this is not easy for any of you who are dependent upon federal government funding. I appreciate that.

My question to you is this. Are there minutes of meetings available that indicate there were discussions to replace this project with L5L, with introducing--

[The Chair, Conservative, Joy Smith]

Your time is up, Ms. Neville. Who did you direct that to? We'll get the answer.

[Anita Neville, Liberal, Winnipeg South Centre, MB]

It was Ms. Medwick.

[The Chair, Conservative, Joy Smith]

Ms. Medwick, can you answer as quickly as possible?

[Heather Medwick]

We have minutes of the board meeting where we discussed what the decision was for CHVI. I'd have to talk to legal counsel as to whether they're available.

[The Chair, Conservative, Joy Smith]

Thank you.

Ms. McLeod.

[Cathy McLeod, Conservative, Kamloops—Thompson—Cariboo, BC]

Thank you, Madam Chair.

I really appreciate all the witnesses today. I think even as far back as the estimates, we had the opposition, in particular the NDP, indicating that there was much going on that wasn't above ground. We've heard consistently from our chief public health officer, from the witnesses, that indeed we had a process where a decision was made, that there was capacity in other parts of the world. We have an above-board process. It's not reflecting the money that Canada is going to put into HIV/AIDS, and it's also not reflecting on the bad relationship with the Gates Foundation. So I really do appreciate the very clear testimony. I also want to acknowledge the disappointment from the many organizations that did work very hard, and I'm sure it has indeed been a disappointment to you.

There are a couple of questions that I would like to ask. I guess the first one would be to Ms. Medwick.

We've heard that you were advised that your organization has successfully passed the assessment phase and was the winning bid. This really came as a complete surprise to us. Can you tell us how and from whom you were provided that information?

[Heather Medwick]

I was told that we were the recommended applicant from the former CEO.

[Cathy McLeod, Conservative, Kamloops—Thompson—Cariboo, BC]

Okay, thank you.

I don't have much more to say about that because I know clearly within our organizations we've indicated that there was no one who was deemed to be the successful applicant.

The next thing I would like to ask is this. We heard witnesses on Tuesday who suggested that yes, there was a quantity available, but there was not quality available in terms of the capacity. I don't know if either Dr. Bernstein or Dr. Bertozzi would like to comment about when the Gates Foundation looked at capacity. I think it probably dealt with both quality and quantity.

[The Chair, Conservative, Joy Smith]

Dr. Bertozzi, would you take that one, please, because you were very much a part of it

[Dr. Stefano Bertozzi]

The study that was done by Oliver Wyman, which Madam Vice-Chair referred to, looked at manufacturing capacity, and it divided it into several subcategories. But perhaps the most relevant one to your question is that some of the production facilities are certified GMP, which means they are certified by the Canadian and U.S. regulatory agencies as producing product that can be used in human trials. Even not considering those facilities that are non-GMP certified, there was excess capacity.

The study also only looked at production capacity in Europe and North America. It didn't look at the rapidly growing production capacity in India that was referred to by Ms. Medwick, or in China, for example, nor did it look at the production capacity in the large pharmaceutical manufacturers. So we believe that just by looking at the GMP-certified production capacity, there was sufficient production capacity, without even considering whether the non-GMP could be brought up to snuff.

[Cathy McLeod, Conservative, Kamloops—Thompson—Cariboo, BC]

Thank you.

[The Chair, Conservative, Joy Smith]

Monsieur Michaud, would you like to make a comment on that? Are you one who wanted to do that?

[Patrick Michaud, Chairman of the Board of Directors, International Consortium on Anti-Virals]

On the capacity?

[The Chair, Conservative, Joy Smith]

Yes.

[Patrick Michaud]

I'm not sure I could contradict the results of the capacity report that was commissioned. We were surprised, though. Dr. Carver and I have been in drug development for eight years. We had compounds in clinical trials. We commissioned manufacturing for clinical trial lots. There are some issues that come up when you talk about capacity: are you dealing with theoretical capacity or are you dealing with commercial capacity? So when you're talking about commercial capacity, this industry is a very low margin business and needs high volume.

To manufacture clinical lots at a pilot scale is uneconomic, generally speaking. So when the report questions organizations about whether they have theoretical capacity, we would think most of the respondents would say yes. To us, though, when you're running clinical trials, the GMP requirements are such that if you produce a clinical pilot scale run, you probably want to produce it in the same facility at a commercial scale. That's why I think in our organization our application was designed on developing a commercial scale, because you want to curtail the transition between pilot scale lots and commercial production.

[The Chair, Conservative, Joy Smith]

Thank you, Mr. Michaud.

We'll now go to Monsieur Dufour.

[Nicolas Dufour, Bloc, Repentigny, QC]

Thank you very much, Madam Chair.

I want to thank all of the witnesses for being here today.

Much has been said about the lack of funding of AIDS research. Earlier this week, Dr. Engelhardt told the committee that the $88 million earmarked for the initial project would be reinvested. Of course, it remains to be seen if that will truly be the case, but discussions are currently under way between the Bill & Melinda Gates Foundation and the Government of Canada.

I'd like to give you a little more time to answer the question put earlier by Mr. Malo. Where, in your opinion, would the money best be invested? For instance, as Mr. Fowke's was saying, we know that no grants have yet to be awarded under the CHVI. So then, would the money have been better invested in production capability, in facilities, or would it have been better to give the money directly to research groups or to universities?

[The Chair, Conservative, Joy Smith]

Dr. Carver, you raised your hand—and then we'll go to Dr. Fowke after that.

[Dr. Jeremy Carver]

I'll be very brief.

Just to follow up on what Patrick said, if you are a drug developer and you're looking for a manufacturer, the answer is usually, “I will fit you in two years from now when I finish my current runs, which are driving my business bottom line.” What Gates could do—and I'm throwing this out there just as an idea—is to pre-purchase capacity in some of the CGMP-certified facilities that would allow researchers to get priority service. That would meet the original objective. There would be no need to build dedicated facilities here, and it would address one of the criteria in the original call, that the facility had to have three different platforms. You could pick three different manufacturers who had this expertise.

What it doesn't meet is the extra criterion that was in the call, which is flexibility with respect to adapting new technologies and new methods for vaccine production. That is where a more research-dedicated facility would be required.

So one partial solution would be to go with the existing manufacturers and to pre-purchase capacity, so there would be timely production of clinical trial candidates. But there still is a residual research need.

[Nicolas Dufour, Bloc, Repentigny, QC]

Excuse me, Madam Chair, but before we continue with the witnesses, I'd like to hear Dr. Bertozzi's opinion of what Dr. Carver has just told us.

[Dr. Stefano Bertozzi]

We haven't discussed this with our Canadian colleagues, but the foundation is in the process of exploring the option that Dr. Carver spoke of, that is entering into agreements with businesses in order to reserve production capacity in advance.

[The Chair, Conservative, Joy Smith]

I think Mr. Hewitt also wants to say something, Monsieur Dufour.

[Dr. Ted Hewitt]

Thank you very much.

We are in somewhat of a unique position among Canadian universities, because we do have an HIV/AIDS vaccine in development right now.

With respect to what I've heard about capacity and quality, our experience has been that it takes nearly 18 months to source a facility to produce the vaccine for clinical trial lots, and it is very expensive. There were only three facilities that were shortlisted. We chose a facility in the U.S., though I won't name it. We are now ready to move to trials in the U.S. FDA approval has been held up with respect to issues regarding quality.

So I think there's a difference between the theoretical and the practical, but I wanted to give you an example of an actual experience that we've had.

[The Chair, Conservative, Joy Smith]

Dr. Fowke, I think you wanted to comment on that, too.

Monsieur Dufour, I guess you asked a very good question.

Go ahead.