Health Committee on April 22nd, 2010

[Dr. David Butler-Jones, Chief Public Health Officer, Public Health Agency of Canada]

Perhaps I'll start, and I'll turn it over to Frank, Madam Chair.

First of all, there is clearly a difference between mass production of vaccine in production facilities versus the capacity to do trial lot vaccines for research purposes. So the example that you give is a very real one, and that's part of the reason why there is collaboration between different levels of government and GlaxoSmithKline in terms of production of a new fill line. But that's in terms of production during a pandemic or for seasonal purposes. In terms of the production of trial lots, it's very different in terms of size, scope, etc., and I'll let Frank speak to it, because we actually have very practical experience because we do experimental vaccines. We produce experimental vaccines and need vaccine manufacturers in terms of trial lot manufacturers—not big commercial enterprises per se—to be able to do that. Frank can actually speak to our practical experience as opposed to the theoretical.

[The Chair, Conservative, Joy Smith]

Dr. Plummer, would you mind doing that?

[Dr. Frank Plummer]

Certainly, Madam Chair.

In our experience at the National Microbiology Lab we have developed a number of candidate vaccines for viral hemorrhagic fevers. We have in fact had no problem identifying manufacturing capacity for trial lots. There are many U.S. and European companies and a couple of Canadian ones that have that ability. I know of a company, Microbix, in Ontario that offers this capability. McMaster University has developed a good manufacturing practice facility for manufacturing trial lots of vaccines. And I've had companies come to me asking if I had anything for them to manufacture.

So I have no reason to disbelieve the Gates study, and I believe that there is a lot of capacity for manufacturing trial lots up there—that is, in small contract research organizations.

[Carolyn Bennett, Liberal, St. Paul's, ON]

The concern from the candidates for the facility was that there was a needs assessment done. It said we needed this kind of facility in Canada. They put in a huge amount of work in terms of getting their proposals together. They were still asked, even, for updates to their proposals up to late in the fall, and there's no site visit, and then all of a sudden it's determined that we're fine without these facilities when this was the big thing, signing with Gates.

I think we just don't understand what happened in between, that with one study on theoretical capacity, we all of a sudden don't need this capacity in Canada. I guess there have been suggestions that maybe there needs to be an expert panel or at least one more assessment as to whether there really is sufficient practical, realistic capacity on the ground before this is finished.

Then I think the second part would be for Dr. Butler-Jones to tell us about the progress, if indeed this is killed, on where this money will be reassigned.

[Dr. David Butler-Jones]

On a couple of things, one is that isn't quite right. We were not soliciting additional information. The bids were in. There was one point of clarification, but it's not a major point in any way.

The first reality is none of the bids passed the bar. So the external assessment identified deficiencies in technical, management, and financial aspects. The internal review confirmed that. None of them passed the bar to be acceptable proposals. So that's the first point, which is very clear, and there's no doubt in my mind about that. I have actually reviewed...I was not part of the process. I was independent of the process. But following, with all the interest in this, I have myself looked at the proposals and looked at the reviews, and I would concur with the assessment that none of them passed the bar. So that's the first point.

The second point in terms of capacity, as Dr. Plummer—

[Carolyn Bennett, Liberal, St. Paul's, ON]

Just to be clear, that's the paper exercise, but if there were questions about it, I think what the candidates felt is that usually there would be a site visit so they would have the opportunity to clarify. So these were killed just based on the paper exercise?

[Dr. David Butler-Jones]

No, that is a matter for government procurement. It is the same as a matter for research funding. I have submitted over the years. I have received large amounts of research funding over the years, and I've also been denied research funding over the years, and it's the luck of the draw. It's not that somebody came back to me and said “it's pretty good but it could be better”. You're either in or you're out, and it's the same for government procurement. There are very clear processes to make sure it's fair. They do not go back and give people a second chance. As it turns out, none of them passed the bar.

At the same time, going back to the capacity issue, three or four years ago, whenever this process started, Frank and I were both part of the discussion at the time, of interest in the Government of Canada partnering with the Gates Foundation on an initiative. The Gates Foundation identified at that time that there appeared to be a gap in terms of a contract manufacturing facility for small trial lots of vaccine. As part of the due diligence, because again, time passes, you need to continually check that, which they did. The subsequent study identified—as has been our practical experience in the National Microbiology Laboratory in terms of getting our own vaccine trial lot produced, and as has been the experience of others around the world who actually do it, as opposed to those who talk about it—that it's there. The study actually confirmed that.

Given that we had none that passed the bar and we had a study that showed that the previous capacity gap had been filled, to me it was a very simple decision of how best to spent $82 million: Is it on another facility that may or may not be used; or is it on other initiatives that actually could address the issue of a successful vaccine, which is tremendously difficult, against HIV?

In terms of the subsequent question, about what do we do, we're in active consultation with the Gates Foundation, with stakeholders and others, to try to figure it out, but quite honestly this process is delaying us from that. The sooner whatever needs to be done here can be resolved, it will allow us to move more quickly on the next steps in terms of the Canadian HIV vaccine initiative.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Butler-Jones.

We'll now go to Monsieur Malo.

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

Thank you, Madam Chair.

When we examined this question and discussed it with several experts, we learned that developing an HIV vaccine is not as simple as developing all the vaccines we have because the HIV virus is unique. It is not a matter of simply taking pus and doing various analyses of it as is done for all of the known vaccines. We know that manufacturing and developing an HIV vaccine is more difficult, and it is different.

We also learned through this process that changes are occurring rapidly. There are imponderables that mean that the trajectory we thought we could follow is not the right one. The issue we are working on at present proves this. When the announcements were made, it was thought that the vaccine was going to be developed and that we would need additional facilities to manufacture it, based on a pilot project. Three years later, we realize that this is no longer what needs to be done.

In a case like this, when we are working with a different virus, where the processes are different and you have to adapt rapidly to unexpected changes, don't you think that the 2007 announcement was inappropriate, to say the least? I have the impression that it started there. It's the fact that this competition was launched with great pomp and circumstance, that everyone was told that with the Bill and Melinda Gates foundation the government of Canada was going to set up this facility. Don't you think that doing that before being sure contributed to the present confusion? My second question for you, Dr. Butler-Jones, is this. As of now, what is happening? What are the timetables? What are the next steps? Who are you working with? How are you going to make sure the available funds are allocated to HIV research?

[Dr. David Butler-Jones]

Thank you, Mr. Malo.

This is a changing process. It is very difficult to develop an HIV vaccine because of the effect of HIV on the immune system. If we manufacture a vaccine that produces a similar syndrome, that's a bad thing. The question of lowering immunity is a challenge all its own. It is always possible that a vaccine will have that effect with the experiments. We have to be sure that the vaccine is safe. This is very important.

The capacity to manufacture the vaccine has improved since the decision. That decision was the best one for the time. Good advice was given and good ideas provided, but the world has changed. Now, it is a challenge, a big challenge. It is wise to have the resources needed for developing an effective HIV vaccine. The other $82 million may make it possible to work on other aspects, not the...

bricks and mortar.

It is a big challenge for the scientific community. There is a possibility of a vaccine, but while we are waiting, there may be a lot of surprises.

Frank, do you have anything you want to add to that?

Or maybe it's back to you. You may have wanted to do another question.

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

What are the next steps and what is the timetable? It is important to know where the money on the table, which comes from the government and also the Bill and Melinda Gates Foundation, is going to go.

[Dr. David Butler-Jones]

All the partners in this program have provided money. We have consulted the experts, the foundation and the others, to determine what is possible. Their commitment is unequivocal. Over the next few months, I hope...

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

Over the next few months, are we going to have a clearer timetable in terms of projects?

[Dr. David Butler-Jones]

Yes, I hope so. We were busy replying to the committee. This is very important to us and to the committee. If the committee completes this study, progress may be faster.

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

Dr. Plummer, you specialize in microbiology. Can you tell us where there is still work to be done and how we should look at the situation for manufacturing or creating an HIV vaccine?

[Dr. Frank Plummer]

Madam Chair, let me start by saying that I was as disappointed as anyone with the turn of events related to the CHVI, but I am quite excited by the opportunity that we have before us, in that the Gates Foundation is continuing in its commitment to this initiative, as is the Government of Canada. To me, the biggest obstacle to the development of an HIV vaccine is, as I understand, a natural immunity to HIV. For all vaccines we have some kind of knowledge of what natural immunity is all about. So we know, for instance, that if you get natural measles, you are immune to measles for the rest of your life, pretty much. So you can make a vaccine based on that knowledge. For HIV, we don't have that kind of understanding.

I think that Canada has been a leader in trying to understand natural immunity to HIV, and I believe that investing the $88 million that was to go to a not-needed bricks and mortar facility will allow the science to advance more rapidly and to allow Canadian leadership in this field.

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

Thank you, Madam Chair.

[The Chair, Conservative, Joy Smith]

Thank you very much, Monsieur Malo.

Ms. Wasylycia-Leis.

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

Thank you, Madam Chair, and thank you to both Dr. Plummer and Dr. Butler-Jones.

Just at the outset, Madam Chair, let me put on record the reason for my abstention from the vote pertaining to the failure of the ministers to be at this committee. I felt the motion had been watered down to the point where it was meaningless. I actually believe that a week is a reasonable amount of time to expect ministers to respond. On that basis, I abstained.

I also want to say, however, that I think the reasons for this committee and these hearings are very important and should not be dismissed as political opportunism on the part of the opposition. I think we were all shocked to learn that this promise made by the Conservatives in 2007 with great fanfare and the participation of Bill Gates's foundation, and seen as a most exciting moment for Canada, was suddenly stopped after the process was already under way, and that all kinds of conflicting evidence and reasons for this came out.

I think it's the role of this committee to try to get to the bottom of that. When I first proposed the motion, it wasn't to go on any witch hunt; it was to see if there were some way of presenting all the evidence and then convincing the government there was good reason to continue the project and to find some way to start again or review the bids or make it possible. I still hold to that belief, although with every passing day it seems to me that the whole project is a dead duck. I guess there's not much point in trying to get a dead duck to come to life, but I think maybe we can learn something from this and maybe we can play a role in how the money is spent.

I have continued with my line of questioning because I don't really see a lot of logic in the arguments coming from of the government and I see a lot of contradictions. I just want to put on record three of those and then ask a couple of quick questions.

The first is the suggestion that none of the bids demonstrated that they were sustainable or proved they were economically viable. I think that's just not the case, especially if you look at the Winnipeg bid, where in fact the Government of Manitoba put $15 million on the table as a way to make the project sustainable. So I think there's lots of evidence to refute that argument from the very beginning.

The second is the whole question of the other bodies out there, the other ways in which these clinical trials can proceed. I think the Gates Foundation representative made a valiant attempt at that the other day, but didn't give us any hard evidence. In fact, he left us with the belief that the Gates Foundation or this government or somebody is going to have to get through to some private company somewhere around the world and demand that our scientists get to the top of the line. Just to quote from one of the scientists who is concerned about this whole development:

Saying that there are existing production capacities now accessible for vaccine discovery is about as reasonable as saying homelessness of the poor has been addressed by excess capacity at the Ritz Hotel. Commercial manufacturing facilities are just not accessible to independent academic researchers working in discovery.

We heard that from the representative of the University of Western Ontario, who actually talked about standing in line for a year or two just to access a lab to test a discovery. It's been verified by much in-depth research, especially by the “Report on Business” in The Globe and Mail at the end of 2009, which said in regard to why drug companies spend so little on vaccines:

Why spend time on such a low-margin business as vaccines when a company could make a fortune developing a new blockbuster drug?

That's what we're up against, and that's why this proposal was so exciting.

The last concern I have is that there's all this talk about investing this money in other things, but at no point has a list been provided. I have to say to Dr. Butler-Jones, this committee has not stopped any of the work. I'm sure it's all proceeding. I would like to start with that as my first question. Specifically, it's been said that $51 million of the $137 million has already been spent, but could we have a breakdown of where that $51 million was spent?

[Dr. David Butler-Jones]

The answer to the first question is yes, of course we'd be happy to do that.

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

Could you give us some rough ideas now where that money has gone?

[Dr. David Butler-Jones]

I could ask Steven to come to the table, and he could speak to that.

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

Okay, why don't we have Steven come to the table, but I'll keep asking questions.

Actually, could we just have a breakdown? Could you just table for us a breakdown of where the $51 million has been spent? That's all we need right now.

[Dr. David Butler-Jones]

Certainly, and as I've said, I've committed to that.

In terms of the other half of that question, the point I was making is that a tremendous amount of energy is being spent by me, by those who are responsible for the CHVI, by the Gates Foundation's relevant people, on responding to a range of allegations and issues and trying to be clear. They keep saying the same things I've been saying, which is the absolute truth. You know there's only one thing I know how to say, and that's the truth. It's taking a lot of people's time and it is slowing down the process. It hasn't stopped the process, but it is slowing it down.

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

What I would like to know then is, at least of the $88 million that is now up for expenditure—because the project is apparently not going ahead, much to our chagrin—what is the vision for that expenditure? Will it be seen as an investment in Canadian research so that we can actually produce jobs, attract scientists, and continue to be leaders in this field of vaccine development? Or is it going to be spread across the land as grants that do not necessarily have a return on investment?