Health Committee on April 13th, 2010

[The Chair, Conservative, Joy Smith]

Can I just say this was provided to the clerk by e-mail. I don't believe it has been distributed. It wasn't translated.

We do have it translated now? I didn't know it was here. We can hand it out so people have it.

[Dr. Rainer Engelhardt]

If it's agreeable with you, I could give just a brief overview of that, because that would give you the chronology.

[The Chair, Conservative, Joy Smith]

Absolutely. We'll make sure everyone has it.

I'll just give you a moment to hand it out so we don't lose time here. I wasn't aware that the clerk had it with her today.

[Dr. Rainer Engelhardt]

From the perspective of time, if it's agreeable with you, I already mentioned that in April 2008 the invitation for the LOIs, the letters of intent, had gone out.

There was a response that we received by June 15—the LOIs from applicants. Then in November of that same year, 2008, four of the applicants were informed that their LOIs were successful, adequate to solicit a full application. They were invited to submit their applications, which then were received on March 25 of the following year, 2009.

Coincidentally, in March 2009, the Bill and Melinda Gates Foundation started their due diligence with respect to capacity. This was done really independent of us, of the Government of Canada, at that time, but it's a natural and I think a normal due diligence process.

So the applications were received, and then for really the rest of that year those applications were assessed according to, as we've said, the scientific and technical criteria by the external committee. They were also, subsequent to that, assessed on the basis of some internal reviews that the terms and conditions for the applications had already identified. We identified that there would be an external review by an external committee—a scientific and technical committee—and there would also be an internal review with respect to value for money and feasibility and with respect to risk to government and basically to the Canadian taxpayer.

As we said, that external review was completed by the end of June. In July, it was basically tabled to the Government of Canada to take voluminous assessments to the people's desks and to go through and collate the information. Then, in July, the Gates Foundation tabled its study, the Oliver Wyman study, that said there was capacity available. In fact, that made our assessment of sustainability more difficult in that we now really were dealing with an additional risk--that risk, or value judgment almost, being posed by the fact that there actually were capacities available, and was it valuable enough to repeat that capacity within Canada with respect to other priorities for HIV advancement?

So that internal process took some extensive time—it literally took many months, as I think all of us know here—but the volume of material that had to be assessed and validated and gone through was very large.

The end result was that towards the end of the year, it looked as if we were going to be saying, “Hmm, the facility issue is a serious one.” It came down to the crunch, really, of the final stages of evaluating what was going to be the decision that would go public, and informing the applicants on their application alone with respect to all of its criteria, including value for money and sustainability, and then also announcing that they ultimately would have to do that and wanted to do that, but the facility proposal, that component, also no longer made sense in Canada.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Engelhardt. Have you just about finished?

[Dr. Rainer Engelhardt]

That's fine. I think that captures the extension of the process.

Thank you.

[The Chair, Conservative, Joy Smith]

Thank you so much.

We'll now go to Monsieur Dufour.

[Nicolas Dufour, Bloc, Repentigny, QC]

Thank you, Madam Chair. I would like to thank the witnesses for being here to discuss such an important subject.

My two questions will be mostly financial in nature. Dr. Engelhardt told us at the beginning that the $88 million set aside for this project would be invested, at least for the most part, in the fight against HIV. He also told us that an evaluation process was underway in order to determine where that money would go and how it could be invested.

I wonder as well—this is the first question I would like to ask the witnesses—where should the money go? The second question is: is putting $88 million into the research facility the best use of the money? Could something else be done? The witnesses are in a position to answer that question, I feel.

[The Chair, Conservative, Joy Smith]

Dr. Engelhardt.

[Dr. Rainer Engelhardt]

Thank you.

It really is the valid question that we're dealing with at the moment: how do we effectively apply the money that had previously been earmarked for a facility, as we said, to where it can now provide the greatest value?

I have to start by repeating what the process had been. We had come with a value judgment that going forward with a facility would not give us as large a return on moving the HIV advances forward as other needs. As we're looking it at right now, the other needs really range from gaps in scientific information that's necessary to develop a new vaccine to gaps in moving the vaccine forward through the clinical process, not only in clinical trial facilities accessible in Canada but also through clinical processes in countries where we actually need to have an effect, for instance, in western Africa—maybe there'll be a question on why Africa—to the point of providing some assurance that the vaccines can be delivered well in the target areas. Those target areas could be in Canada or outside Canada.

It's a very large project. Many tens of hundreds of millions of dollars are spent globally to move the HIV agenda forward. We, Canada, jointly with the Gates Foundation, need to pick and choose where we can have the greatest effect for our money.

As a final quick point, we were not acting alone on this. We are in a partnership with the Gates Foundation. Even though the Gates Foundation puts in less money than we do, their influence and reach into the global HIV vaccine advancement community is phenomenal.

[Nicolas Dufour, Bloc, Repentigny, QC]

Thank you, Mr. Engelhardt.

Could Mr. Cameron and Mr. Gerson also tell us where they feel the money could be invested?

[Dr. Donald Gerson]

I don't know exactly what is being considered right now in terms of alternate uses for the funds. Having been involved in many HIV projects, a lot of funds are spent on clinical trials. A lot of funds are spent on research, but it's been clear for some years that the gap between R and D and commercialization is large.

This facility would have bridged the first part of that gap, to make clinical trial materials that meet all standards and to make them so that the clinical result is not compromised by the quality of the vaccine used in the clinical trial, as has happened with a number of HIV vaccines. I still feel it's a significant gap within the entire HIV enterprise. There are other gaps, but that's a very significant one. To the best of my understanding, it is still inadequately met.

[The Chair, Conservative, Joy Smith]

You only have 15 seconds left, and I will watch the clock.

Dr. Cameron.

[Dr. Bill Cameron]

I would say the money should be spent in Canada. It should be spent on vaccine discovery development. One unmet need is a production facility. It should be spent there. Second, if not there, then it should be used to facilitate academic investigator-driven research on vaccine development in Canada.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Cameron.

We will now go to Ms. McLeod.

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

Thank you, Madam Chair.

Thank you to the witnesses today for a very important discussion.

FIrst, I have a short question. We've heard the term “GMP”, but I thought I heard Dr. Gerson say “GLP”.

[Dr. Donald Gerson]

Let me give you a quick vocabulary lesson. GLP, good laboratory practice, is usually applicable to the very earliest stages of developing a vaccine. GMP, good manufacturing practice, is what you have do when making a product that will go into a person either at the clinical level or the commercial level. The other one we're probably going to hear about is GCP, good clinical practice, to make sure the clinical trial follows all of the regulations.

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

Thank you. I was trying to determine whether they were the same thing or different. I appreciate the clarification.

I think perhaps unlike any other effort, this has truly been a global effort. There are many different areas of need. It's certainly been determined by the Gates Foundation that there might be capacity in this area. There's certainly no lack of places to spend funds in terms of moving the initiative forward.

I'd like to hear a little about how collaborating with the Gates Foundation has helped the CHVI to work towards achieving the main goal to aid in the development of a safe, effective vaccine. I'd like to hear about the relationship not only with Canada but throughout the world. It's a very important piece of what we're doing, Dr. Engelhardt.

[Dr. Rainer Engelhardt]

Thank you.

We haven't spoken very much about the Gates Foundation, and I'm going to be limited in what I can say because it's, in a way, second-hand. My observation, working with the foundation, has been that they are very scientifically driven and use evidence-based science as the basis for any of their decisions. They are also very strategic in developing their program. Their program is focused on areas of need, in this case for HIV, typically in Africa rather than in Canada. They are also, however, very much impressed by Canada's capabilities or, as esteemed colleagues have said, their record and history of having produced extremely valuable knowledge with respect to HIV vaccine production and the overall definition of the disease altogether.

There is a coupling that has come together between our capacity in Canada and the very fact that we have definite social and medical problems with HIV/AIDS expression in Canada in a whole series of populations. So we think whatever we do jointly with the Gates Foundation is going to be beneficial in Canada to Canadian social and medical structures as well.

There was a comment that the Gates Foundation is in itself strategic, that it is developing a large strategic plan for how the vaccine implementation can benefit the issue of HIV all over the world. It hasn't been mentioned around the table here that the Gates Foundation supported a vaccine trial. It was an early-stage vaccine trial in Thailand, which, for the very first time, had some efficacy. That has given us a tremendous boost in thinking that perhaps there is a solution available. It's the first real indication. That is actually forcing the issue more. We have a promise that there is a vaccine coming, which is being developed through the Gates Foundation. Trials on people have shown a low level of efficacy, not one you would say is ideal yet, but at least the solution seems to be around the corner.

It is that large view of the issue that the foundation has taken. Canada is, frankly, a small player, but for them we are a very important player. The Gates Foundation has said they view Canada as an essential partner in their efforts. Altogether these are good things for us, as the Government of Canada, to move our own very specific agendas or points forward to where we think we can get the greatest value for our expenditures.

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

Do I have more time?

[The Chair, Conservative, Joy Smith]

Yes.

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

Perhaps I will ask this question to Dr. Cameron. Prior to any of this discussion regarding a facility within Canada, if there had been a really promising vaccine candidate, how would you have processed it to move it to the next steps?

[The Chair, Conservative, Joy Smith]

Time is up, so just respond very quickly, Dr. Cameron.

[Dr. Bill Cameron]

Before this discussion, if I had had a good vaccine candidate, I would have taken it to a GLP/GMP facility and asked them to produce a lot suitable for conducting clinical trials. I would then have gone to the CIHR Canadian HIV trials network with a proposal and had them vet the proposal and, with public funding for operational costs of the clinical trial, execute the clinical trial. That's what I would have done.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Cameron.

We'll now go to Ms. Murray.