Health Committee on April 13th, 2010

[Kirsty Duncan, Liberal, Etobicoke North, ON]

With respect, Dr. Engelhardt, may I interrupt?

[Dr. Rainer Engelhardt]

Yes. I can't answer that with a yes or no. I'm sorry, but--

[Kirsty Duncan, Liberal, Etobicoke North, ON]

Okay. May I interrupt?

[Dr. Rainer Engelhardt]

Sure.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

The Gates Foundation came out in July of 2009. It started with a disclaimer. It talked about what evidence it didn't look at. It looked only at capacity rather than quality.

Dr. Gerson was part of the original process, and he gave a critique of that study. It seems that part of the government's decision is based on one study with which there were certainly challenges. If Dr. Gerson was trusted enough to be part of the initial process, why are his comments not being taken into account?

[Dr. Rainer Engelhardt]

I can't speak for the internal evaluation carried out by the Gates Foundation itself. For us, when we saw the report, it talked about capacity, certainly. Also, by more than inference, in stating that quite a large number of the facilities identified had records of being GMP certified--that's good manufacturing practice--or could easily be GMP certified, it meant that from a regulatory perspective, this assessment of quality carried over into a statement that, yes, there was capacity, and yes, that capacity--these are contract manufacturing organizations in that large industry--had the ability to produce a pilot-scale manufactured vaccine to the standards regulatory authorities would require to move a candidate vaccine through this early stage of production. That early stage of production is an essential component of clinical trialling.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Engelhardt.

We'll now go to Monsieur Malo.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Thank you, Madam Chair.

When the Prime Minister of Canada and Bill Gates are on the same stage to announce the establishment of a centre for clinical trials and a strategy, that has to be something significant, it seems to me. It also has to be a goal set jointly by the Government of Canada and the Bill and Melinda Gates Foundation. I find it curious that, after an announcement like that, the decision is made to end the project.

Why did the project stop being significant when, in 2007, it was significant enough for the Prime Minister and Bill Gates to announce that it was being set up?

[The Chair, Conservative, Joy Smith]

Go ahead, Dr. Engelhardt.

[Dr. Rainer Engelhardt]

That's a very appropriate question you ask. It reflects the thinking processes that needed to go on during the evaluation period. If there were no pilot-scale manufacturing capacity, which typically requires production of 10% of the volume of a production batch--that is sort of a regulatory requirement--to GMP standards, there would be a real gap in moving forward a candidate vaccine discovered in Canada, or anywhere, to actually apply to humans. That was assessed, in a separate study, in 2004--I think I have the year right--as not being available in Canada. Steven, am I right that it was 2004?

The scene had changed rapidly, though. I guess when the general background people at the Gates Foundation, in particular, decided as part of their due diligence to re-evaluate whether pilot-scale manufacturing capacity was still unavailable to researchers globally, the finding was that, yes, over the past two or three years, pilot-scale manufacturing capacity had come on stream and had become available. Keep in mind that pilot-scale manufacturing does not involve the same level of effort required in a full-scale, industry type of vaccine manufacturing plant.

The changes that can happen over two and three years can happen relatively quickly. We ended up with a decision that manufacturing capacity for pilot-scale clinical trialling actually had become available, and it no longer made sense to spend $88 million for that priority in HIV vaccine development versus other priorities that were also on the table.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Despite those comments, these doctors, who seem distinguished to me, tell us that present facilities do not allow us to accomplish what we could have established with the new centre for clinical trials.

How do you respond to them? Your explanations do not seem to have alleviated their concerns.

[Dr. Rainer Engelhardt]

With due respect to Doctors Cameron, Gerson, and Sekaly, we would like to differentiate the pilot-scale manufacturing capacity from the full-scale vaccine facility. As the report--and not us, per se--said, the pilot-scale manufacturing capacity was available to researchers globally, so it really comes right down to the point of a judgment call on value for money. That's really what the bottom line was: is it better to spend the $88 million for the many other needs in moving candidate vaccines forward, or even discovering effective HIV vaccines, than to spend it on duplicating something in Canada that could have many benefits on the Canadian scene and moving that forward? A value judgment was made, and what we are really here to relay to you is that the value judgment came down on the side of spending the money otherwise.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Dr. Sekaly, did your leaving Montreal have anything at all to do with the decision not to proceed with this project?

[Dr. Rafick-Pierre Sekaly]

I don't think so. My decision to move to the U.S. was part of a much larger decision-making process in my mind.

That decision reflects some of the reasons I left. One of the very important reasons I left was that I wanted to do research on human subjects, do as much as I could in clinical trials to accelerate vaccine development. We test a lot of vaccines on mice, and they all work. When you get to humans, nothing works. I thought the pilot plant was going to enable us to make small lots that were going to allow us to do small pilot clinical trials with humans.

Despite the fact that when I left.... It was long before my time that the decision was made. I think it certainly would have given Canada a very strong competitive edge in the current atmosphere of vaccine development. We realize that everything we do in species other than humans doesn't give us the right answers. Having a place where you can make those small pilot-scale vaccine lots certainly would have allowed us to contribute this kind of effort. Having this vaccine plant would have enabled not just me but many other Canadian researchers to contribute in a very significant way to the current realm of vaccine development, which is to do work on humans, and it's unfortunate that it's not going to happen.

[The Chair, Conservative, Joy Smith]

Thank you very much, Dr. Sekaly.

We'll now go to Ms. Wasylycia-Leis.

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Thank you, Madam Chairperson, and thanks to all of you for your presentations.

I want to begin by stating to Dr. Engelhardt and Mr. Sternthal that you're telling me today much of what you told me on February 19, after I wrote to the minister asking for an explanation of this decision. I said to you at that time that I didn't believe you then, and I don't believe you now.

In fact, there are so many contradictions in the testimony of you two, Dr. Butler-Jones, and the minister that one can't even keep up with the changing message coming out of your government, which only leads us to believe that you've all been given a talking point and you're getting it mixed up. You can't quite all get it out the same because in fact there is no truth behind it.

Let me point out of few of the contradictions and then ask Bill Cameron, Dr. Gerson, and Dr. Sekaly for their understanding of why this could have happened, because what's been said officially just does not make any sense. I find it hard to believe, both Steven and Rainer, that you don't read the newspaper. In fact, it was reported in December 2009 that there was a web page announcement saying the whole project had been pulled, and you say you don't know--

[The Chair, Conservative, Joy Smith]

Ms. Wasylycia-Leis, could you get to your question?

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Madam Chair, I have seven minutes, and I would appreciate it if you would let me ask my questions. Thank you.

On February 19, when I asked whether a decision had been made, you said it had not in the traditional sense.

Even before March 16, I talked to Dr. Butler-Jones and he did not even understand that the proposal on the bids was for a non-profit facility. He only realized that by the time he testified on March 18.

On March 16, the minister said no decision had been made. The head of the Public Health Agency, Dr. Butler-Jones, contradicted her and said yes, a decision had been made, because in fact he said there was a ranking. A ranking is a decision.

Today you're trying to tell me that there are scientific and technical issues at stake, yet no one has ever raised scientific and technical issues with the applications in the past. In fact, the most recent argument has been about sustainability, which doesn't make sense because in fact that was part of the bid process to begin with. Otherwise, why would the Manitoba bid, the Winnipeg bid, actually go to the trouble of getting a $15 million commitment from the provincial government to be able to sustain the centre and get it on a solid footing? So the questions of sustainability weren't even addressed.

You haven't given us a single solid argument, except for leading us to believe that some political interference happened. You're trying to give us the line and you're failing dismally.

So I want to ask Bill Cameron, first of all, were you ever given any detailed explanations about the rejection of the Winnipeg bid in terms of scientific or technical advice? Tell us also about whether sustainability was part of the original requirements.

[Dr. Bill Cameron]

To the first question, no.

To the second question, I was not party to the original call for proposals. I understand, through consultation with others at the Canadian Association for HIV Research, that economic sustainability was one of the features of that original call.

If I may add to that point, part of the reason that the explanation for cancellation made no sense to me was that to say we have production capacity for small lots for early clinical discovery and development and that it's merely provided by commercial capacity does not address the issue of discovery and invention, simply because commercial goods manufacturing facilities are out of reach of discovery. The market for commercial production facilities is corporate. We don't get publicly funded grants to contract out vaccine production for a university or investigator. That doesn't happen. It's a corporate level kind of capacity we're talking about. In my opinion, if we want the GLP and GMP capacity to address issues of discovery and invention, it's not going to be done in the industry sector.

So in answer to the second part, it made no sense to me, but you know....

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Let me go to Dr. Gerson. The interesting timing of this document, in July, supposedly after the decision was made that none of the applicants met the bill, was only to tell us that in fact the alternatives to this non-profit facility were any number of private manufacturers.

You've pointed out the difficulties with this study, and so has the actual author of this study. Can you tell us where in the world there is a facility now that can do the kind of work that any one of the four bidders might have been able to do had this process been completed?

[Dr. Donald Gerson]

In looking for exactly that kind of capacity and doing a very detailed assessment of GMP capabilities and quality aspects a few years ago, we came down to a very small number. There was one in Germany where the German government had invested a large sum of money to make a very nice, modern facility. They had implemented GMPs quite well, but needed help from us to make it better. That was basically an economic development project in old East Germany. There was also one in Vienna. In fact, it was only good for the very earliest stage, not even for production of the vaccine per se, but essentially for laboratory work, as they had some exquisite small labs.

We were strapped looking for places, though there was also one in southern California that we used. So there we were, running all over the world trying to solve the problem. We visited many, many places, but very few qualified.

Today, there are maybe a couple more. There's a group of places under one ownership in St. Louis that might be able to do some of this, but in that case there's a capacity, cost, and scheduling question. There's also one in Rockville, Maryland, that I was involved in setting up, funded by the Gates Foundation. However, it's only for bacterial vaccines and it's pretty much dedicated to tuberculosis. After that it gets really thin.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Gerson. I gave you a full extra minute to finish your answer.

We'll now go to Dr. Carrie.

[Colin Carrie, Conservative, Oshawa, ON]

Thank you very much, Madam Chair.

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

I wanted to give Dr. Engelhardt an opportunity to respond. I felt our last questioner was pretty hard on you in questioning your credibility and that of Dr. Butler-Jones, Canada's top doctor. She said some things that I'd like to give you the opportunity to respond to, including that you hadn't given a reason for the cancellation. I believe you said quite clearly today that it was a judgment call. You said there are a lot of priorities as far as HIV research is concerned and that we know it's a worldwide effort. We even heard from one of our witnesses how important it is for public investment.

However, has a decision been made to remove the funds from the table, or are these funds still going to be made available, perhaps for a priority issue, as you mentioned? Are they going to be made available for other priorities?

[Dr. Rainer Engelhardt]

Mr. Carrie, thank you. You raised several points, but I'll address the last one first, because it brings it all together.

There is an ongoing commitment, a stated commitment, that the $88 million—the $28 million from the Gates Foundation and $60 million from the Government of Canada, amongst its agencies—is still on the table. There is currently an evaluation or assessment going on to determine where such funds should be spent. A multiple number of priorities are under consideration, including recognition of a need in Canada to support the transition from lab bench research to clinical research, and there might very well be a need to set a portion of that money aside to assist our researchers in accessing existing pilot-scale manufacturing facilities, whether in or outside of Canada.

Today, I shouldn't give you any assessment of what those various other priorities are, except that they span the range from research right into implementation of vaccines in needy areas. With the Gates Foundation and the other agencies in Canada, the original partners, or that family, if you like, of Canadian organizations, we are evaluating this almost as we speak. In fact, we have two more meetings on this today.

[Colin Carrie, Conservative, Oshawa, ON]

Thank you very much for that.

What I'm hearing is that Canada is part of a worldwide effort and we're trying to work together as a worldwide team for HIV research.

I did hear a comment by Dr. Gerson, and perhaps you could comment on this. He mentioned that the quality aspect of this was not taken into account. You did allude to it briefly. However, it was a disturbing inference for me, because to me it meant that perhaps some labs out there are not quality labs or are not up to the quality this potential new lab would have been....

Are there international labs out there providing vaccines around the world for people in need that aren't quality labs? My understanding was there are very high standards around the world. Is this something you're aware of among worldwide labs?