Health Committee on April 13th, 2010

[Dr. Rainer Engelhardt]

If I may, I can't make a personal judgment with respect to the quality of one lab versus another. However, those laboratories, whether they happen to be laboratories where there are pilot-scale manufacturing facilities or not, and whether they operate in Canada or the U.S. or Europe, I believe meet the highest level of quality with respect to the regulatory authorities.

Our own regulatory authorities impose scientifically based quality controls in those facilities. I don't have any reservations in that regard. When somebody talks about a facility being an accredited GMP or a certified CGMP, that means the results coming out of that facility can be trusted in order to be able to proceed along the chain from discovery to ultimately having a registered drug.

[Colin Carrie, Conservative, Oshawa, ON]

That's my understanding. My understanding is that this industry has one of the highest qualities around the world. Even Dr. Cameron mentioned that there seem to be so many regulations there, that for worldwide research now you do need that public money. My understanding is that it is still on the table.

I wanted you to comment on something else as well. There have been accusations that the CHVI has not accomplished very much since it was formed in 2007. Can you tell me what has been done since it was launched in 2007?

[Dr. Rainer Engelhardt]

I certainly would be happy to. The federal commitment to the CHVI program at that time was up to $111 million, and $51 million of that has either been committed, expended, or will be expended in pre-determined priorities.

If it's all right with the chair, I would like to have Mr. Sternthal give some details.

[The Chair, Conservative, Joy Smith]

Please, Mr. Sternthal, go ahead.

[Steven Sternthal]

Thank you.

I'll just take one example of what is often the side that is not talked much about, and that is the involvement of affected communities, people living with HIV. We have a number of projects that we're currently funding.

One, for example, is with the Canadian AIDS Society. They have been funded to look at some of the lessons learned from existing public health interventions, existing vaccination programs, to see how we can better prepare the HIV community for the eventual availability of not only a HIV vaccine but other vaccines as well. This is just one example in our community, in social dimensions, where we are working collaboratively with the community as well. On the research community, there are currently 13 projects that have been funded through the Canadian Institutes of Health Research, and they range from coast to coast in this country. Certainly, a large initiative that will be launched in the coming weeks by the Canadian Institutes of Health Research as well as CIDA is a collaboration between Canadian and developing country researchers to continue to push forward the discovery of new vaccines and new vaccine concepts, as Dr. Cameron talked about, which is really critical to ensuring we have a robust pipeline in the long term for finding vaccines.

[The Chair, Conservative, Joy Smith]

Thank you very much, Mr. Sternthal.

We're now going into our five-minute Qs and As. Committee, when I say to you, “Do you have a question?”, I'm giving you a signal that you've used up almost half of your time. It's up to you whether you want to make comments or have questions. I just want you to make sure, because we all lose track of time. I am watching the time very tightly today, so it's not meant as an affront to your questions. I just want you to know the time that you have left.

We're now going into the five-minute round, and I believe Ms. Neville and Dr. Duncan are going to share their time.

Keep in mind that you have five minutes.

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

I have a very quick question to each of you, and I appreciate your being here today.

My quick question to each of you is this. Are you aware that in the early fall of 2009, representatives of the provincial government of Manitoba had been advised informally that they were the successful bidder on the Canadian HIV vaccine initiative?

[The Chair, Conservative, Joy Smith]

Who would like to take that question?

Dr. Engelhardt.

[Dr. Rainer Engelhardt]

We were informed, at least through the media more than anything else, that this had occurred. Literally, we went back internally and scratched our heads, saying, how could that have occurred? We tried to trace it, and there is nothing we can say that would be attributable to the process that we followed.

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

Does anybody else want to comment? No?

Thank you.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

I guess I am still concerned. By saying that none of the applicants were up to the task, this is announcing to the world that Canadian researchers, universities, and private industry could not meet the criteria.

Can you specify or make clear what criteria these applicants failed on? We've heard different stories.

Mr. Sternthal.

[Steven Sternthal]

I'll answer the specific criteria, but first I want to say that the applicants themselves, of course, had many strengths. There was a broad range of organizations and partners that each organization mobilized, and that was recognized throughout the letter of intent stage as well as the application stage.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

You've mentioned that.

[Steven Sternthal]

In terms of specific criteria, we've given, confidentially, each of the four applicants feedback on all of the criteria that were made available to them at the beginning of the process.

Dr. Engelhardt has mentioned that there were criteria in technical areas, in governance, in financial sustainability. All of that specific feedback has been provided to the applicants.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

Thank you, Mr. Sternthal.

Dr. Gerson, how do you feel about the fact that no one met the selection criteria?

If I can ask also, what has the cancellation of this facility done to Canada's reputation in HIV science, and what will happen in a few years if the lab is not built?

[Dr. Donald Gerson]

Well, first of all, it's clear that Canada has spent enormous sums of money developing expertise in infectious disease and vaccines since, really, the inception a very long time ago of Connaught Laboratories, and Canada has been a world leader in this. To say without a lot of detailed explanation that no one in Canada is capable of doing such a thing really is self-depreciating in Canada. I think it's really an unfortunate outcome for the government to say that none of the people it has supported are capable of doing this task, which I think clearly is otherwise. Whether it's directly in vaccines or in large-scale production--I mean, Canada has had some of the best researchers in scale-up and production of biopharmaceuticals at Waterloo, Western, and McGill--it's an extremely unfortunate outcome for this whole event.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

Thank you.

How does this affect Canada's reputation in HIV science internationally?

[Dr. Donald Gerson]

If the government says everyone's incompetent, then people tend to believe that more than what would be said otherwise. Incompetence is my word, but that's the message I think that was essentially delivered. It's hard then for people to go to outside agencies, or to the Gates Foundation, or to NIH and say, “Oh well, you know, really we are competent.”

[Kirsty Duncan, Liberal, Etobicoke North, ON]

I know this is difficult science--you don't predict the future--but what are the potential ramifications of not building this lab facility?

[Dr. Donald Gerson]

I can answer that in a positive sort of way. There was a significant investment when, for instance, we put in the facility in Alberta for making similar scale...similar in terms of stage of going from research to manufacturing lots of material for industrial biotech. But the consequence there was that that area now is surrounded by a number of small biotech firms, and it has had a big economic effect.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Gerson.

Ms. Duncan, your time is up now, thank you.

Ms. Davidson.

[Patricia Davidson, Conservative, Sarnia—Lambton, ON]

Thanks very much, Madam Chair.

Thanks very much to our presenters both here and on videoconference. We certainly appreciate the input that you've given us this morning.

Dr. Engelhardt, I'd like to ask you a question, if I may.

It's been fairly obvious this morning that we've got some differences of opinion and differing views around this table about how and when the decisions were made about the CHVI manufacturing facility. I know you've alluded to the process in your opening remarks and in answering some of the questions, but I wondered if you could just walk us through, step by step, how that final decision was made--if you can give us that chronological order, please.

[Dr. Rainer Engelhardt]

All right. I'd be happy to.

If it's all right with you, if I falter in my memory, I will rely on Steven.

[Patricia Davidson, Conservative, Sarnia—Lambton, ON]

Certainly.

[Dr. Rainer Engelhardt]

I do believe that you have a chronology that was provided, Madam Chair. The applicants, as I said in my introductory remarks--