Health Committee on March 18th, 2010

[The Chair, Conservative, Joy Smith]

Good morning, ladies and gentlemen. Welcome once again to the health committee. I'm glad to see everybody here this morning.

Pursuant to Standing Order 81(5), we are here for supplementary estimates (C) 2009-10, votes 1c, 5c, 10c, 25c, 40c, 45c, and 50c under Health, referred to the committee on Wednesday, March 3, 2010, and, pursuant to Standing Order 81(4), main estimates 2010-11, votes 1, 5, 10, 15, 20, 25, 30, 35, 40, 45, and 50 under Health, referred to the committee on Wednesday, March 3, 2010. We will be engaging in the estimates once again this morning.

I want to say a special welcome to our witnesses this morning.

From the Department of Health, we have Morris Rosenberg, Deputy Minister. Welcome once again, deputy.

We have Glenda Yeates, associate deputy minister. Welcome.

We have Mr. Alfred Tsang, chief financial officer. Welcome again, Mr. Tsang.

From the Public Health Agency of Canada, we have Dr. Butler-Jones, Chief Public Health Officer. Again welcome, Dr. Butler-Jones.

We have James Libbey, the chief financial officer, at our table once again, and we have Mary Chaput, associate deputy minister. Welcome to our committee.

This morning we will not have opening comments. We had them yesterday. We're going right into the question and answer period to give you ample time to cover all the questions you have on committee.

We will start with our seven-minute round, beginning with Dr. Duncan.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

Good morning, Madam Chair.

Good morning to all the witnesses. Thank you so much for coming.

Before I begin today, I would just like to once again raise the unacceptable TB rate among our Inuit, which is 186 times that among Canadian non-aboriginals, and among first nations, which is 31.4 times higher.

This risk is similar to some countries in the developing world. It's unacceptable.

I'm wondering if we would like to consider bringing Dr. Gully back to look at this.

[Morris Rosenberg, Deputy Minister, Department of Health]

Maybe I can just start, Madam Chair.

I would be happy to bring Dr. Gully back. Dr. Gully is with us not just for H1N1 but is providing public health advice generally to first nations and Inuit health branch. Obviously we'd be happy to find an appropriate time to explore that issue.

If you would like, we can address the issue a little bit further this morning. I'd ask my associate deputy minister, Glenda Yeates, to perhaps speak to this.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

I think I'll leave that. Thank you.

[Morris Rosenberg]

Okay.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

Knowing that he is going to be there gives us great faith that this will be addressed.

I'm going to come back to CHVI. What was the initial driving reason for CHVI?

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

Canada was very much interested in being part of global efforts to develop a vaccine. At the time that started, one of the deficiencies, or one of the challenges, was having trial-lot production facilities for clinical trials. That's why, as part of Canada's CHVI strategy, that was one of the areas of focus. In the subsequent time, that has now been addressed, so those resources are better used elsewhere.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

Was the driving rationale the fact that a number of clinical trials failed for reasons related to clinical lots manufactured under inadequate conditions, rather than because of the actual design of the vaccine?

[Dr. David Butler-Jones]

No. As you can appreciate, there are tremendous challenges in the development of a vaccine against a retrovirus. One of the key concerns is that you don't want to actually stimulate... Since the action of the retrovirus is to create a challenge for the immune system, you don't want to actually recreate a challenge to the immune system in otherwise healthy people.

With the complexity of the vaccine, as we've seen in multiple clinical trials, they've been very challenged, and even the one that has some promise still had very marginal benefit. The issue now is finding good models for vaccines that might have the prospect of working. There have been multiple trials that have not worked well, and it has not been about manufacturing; it has been about the basic vaccine itself.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

I'm still struggling with the fact that a due diligence study was undertaken in 2009 after the government announced the partnership with Gates in 2006.

We know the scientific committee met in May 2009, and you kindly offered to provide dates of subsequent meetings. What it looks like is that the international committee was invited in May, and at the same time this parallel process was going on. I think you have made capacity in the world the focus. Shouldn't it have been the quality of manufacturing?

[Dr. David Butler-Jones]

We were proceeding on with the process. As it turned out, none of the applicants crossed the bar. At the same time, given the time elapsed and given the recognition that things had changed in the world, Gates commissioned the study to look at capacity to make sure that we were on the right track. That turned out to illustrate that in fact capacity had increased and that the needs and circumstances had changed, so since we did not have a successful applicant and the capacity issue was now addressed, it seemed much better to use that money elsewhere.

Whenever that takes place, it's a bit like arguing that we could have done something different about H1N1 because H1N1 arrived in April and surely we should have known that it was going to be H1N1 a year before that. You only know what you know as you know it, and there were in fact reviews that identified, when we started the process, that there was this need. By the time we got to that point last year, there was no longer that need. The world changes no matter what we do.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

With reference to the Oliver Wyman report, do you think there are any problems with the study?

[Dr. David Butler-Jones]

In the report itself they identify the limitations, but there is clearly sufficient evidence there about the change in circumstances that convinced people that we now need to redirect those resources to other areas of HIV vaccine work.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

The document does begin with a disclaimer. Do you think it's acceptable that the document is in part based on secondary information that was not independently verified?

[Dr. David Butler-Jones]

For this purpose, yes. You can't do everything and you can't follow everything, but certainly for this purpose, yes.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

The project objectives were as follows: the primary emphasis was on assessing physical capacity, not quality of the capacity, and, where possible, to capture data on prior GMP experience as proxy. The study was to assess the physical capacity, not the quality of the capacity, for manufacturing clinical trial materials for HIV vaccines.

It's my understanding that it was the lack of manufacturing facilities meeting stringent regulatory requirements for vaccine manufacturing that initiated the CHVI program. These vaccines are tested on living people, and we have to ensure the safety of all vaccines. Do you think that study should have included the quality aspects of manufacturing--yes or no?

[Dr. David Butler-Jones]

These production facilities are all subject, where they are, to the usual kinds of regulatory controls, as would be a facility were we to build it here. If we built it here, there's no guarantee that it would be any better than one built anywhere else. That's just a practical reality.

The point is that for the clinical trials, for ethics reviews, for all of these purposes, they have to meet those standards. It's in the scientific world; you're not going to be able to cover 99.9999% of every issue or every question. The point is that the capacity is there and it's with reputable organizations, and the feeling is that there is sufficient capacity now to address what we need going forward.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Butler-Jones.

Go ahead, Monsieur Malo.

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

Thank you very much, Madam Chair.

Unfortunately, this morning I am going to have to revisit the comments made on Tuesday by Michelle Boudreau, the director general of the Natural Health Products Directorate. As I pointed out on Tuesday, the figures she provided did not seem to correspond to the figures we were given by the Library of Parliament Research Service. I am going to quote Ms. Boudreau, who said: “Within this backlog, there are only 193 product applications left to be completed.”

That means that when we look at the backlog, the pile of what is left to be completed, we see that all the rest have been completed. There are still 193 applications left to be completed in the pile. The rest have been completed, with a yes or a no. That is what “completed” means.

Here is another quotation from what Ms. Boudreau said: “So, we are very confident that we will reach the stated objective by the end of March and within the timelines we had set. We expect to have completed everything that is outstanding, in other words 3,000 licensing requests by the end of December 2010.”

We look at the two piles, the pile that is backlogged and the pile of applications after April 2008, that is all that's left. For the rest, Ms. Boudreau told us it was 3,000, while according to the Library of Parliament Research Service, what is left is 10,705 applications. I am asking Mr. Rosenberg to tell me what the real figure is, is it 3,000 or 10,705?

[Morris Rosenberg]

Thank you for the question.

I am going to ask Ms. Boudreau. I am going to ask her whether she can explain the difference between the figures from the Library of Parliament researchers and hers.

[Michelle Boudreau, Director General, Natural Health Products Directorate, Department of Health]

Thank you.

I am certainly going to try to explain the figures and I admit they can sometimes cause confusion.

In part, it is because we are using two terms. I am going to use the English term because I think it expresses it better. In French, we would say it is the same term. In English, we say “addressed”, while in French, we say “traité”. When we talk about the term “addressed” in English, we mean that either the licence has been issued for the product or we are in the process of processing the application, that is, we have reviewed the application, we are in the process of evaluating it and we have at least sent a request for further information in order to complete the application. We are talking about these three things when we use the term “addressed”, which is not easy to express in French. In that language, we say “traité”. So it is that number, 193 applications, that are left to be addressed, as I said the other day.

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

So you are no longer using the word “complete”?

[Michelle Boudreau]

No, because for the term “complete”, I'm going to come back to that.

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

That is the word you used on Tuesday, “complete”.

[Michelle Boudreau]

Right, I apologize if I said that, but the distinction is that 193 applications are left to be addressed, and in the total exact figure, which is 3,098, the rest, that is, the 3,098 less the 193, all the applications can be completed with a final decision by the end of December. However, between now and then, I can't tell you that we will have completed the 9,764 remaining applications. So it isn't just the backlog, it is the normal workload. That is the distinction to be made, because I know the two different terms can cause confusion.