Health Committee on March 18th, 2010

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

I asked the minister the question on Tuesday and I asked her whether, as she had told us on February 10, 2009, she was going to eliminate the backlog. When I say “eliminate”, when we are talking about a deficit, that means there is none left, it is zero. That is the term she used here, in the committee, in February 2009. She talked about eliminating the backlog before March 31 and I was told yes. So are you still confirming that the backlog will be eliminated by March 31?

[Michelle Boudreau]

No, I am simply going to go back to what I said earlier. The backlog will be “addressed”, in English, because I think that expresses it better, before the end of March, and the backlog will be eliminated, if you want to use the term “eliminated”, before the end of December of this year.

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

What is the complete deadline? Because the deadlines are getting pushed back. There was talk of December 2009. You gave yourselves a number of internal rules. You were talking about March, but ultimately, it's December, and it ends up being a little later. But I think people are entitled to know what the real deadline and the real budget you have given yourselves are. Those are legitimate questions and we are looking at contradictions and also fluctuating information. Are you able to tell us? There are jobs and revenue at stake.

[The Chair, Conservative, Joy Smith]

Monsieur Malo, your time is running out, and we need her to answer the question.

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

Merci.

[The Chair, Conservative, Joy Smith]

Thank you. Calm yourself.

[Michelle Boudreau]

For the year and a half I have been the director general, we have always been talking about the same deadlines. The first deadline you mentioned, in 2009, is the only one we see in the present regulations and it applies only to products with a DIN, Drug Identification Number. These are products that were in fact regulated under the former regulations that are now transferred to the new regulations. That is the only deadline in the regulations. You will not see another. So as a department, we adopted a deadline that we announced several times to the industry and consumers, to tell them: “This is the deadline we have given ourselves, it is an internal deadline.”

As I said earlier, we are in fact on the right track to address the backlog before the end of March. That is the deadline we have been announcing in several of our documents for at least a year. For the December deadline announced to people a few months ago, we are in fact on the right tract to complete the backlog, 3,098 applications before the end of December 2010.

[The Chair, Conservative, Joy Smith]

Thank you, Madam Boudreau.

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

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

Thank you, Madam Chairperson.

Thanks to all of you for coming back today.

I want to go back to Dr. Butler-Jones--as he would expect me to--on the Canadian HIV vaccine initiative, and refer specifically to the process pertaining to the four bids for the actual vaccine production facility.

On February 21, in a very long conversation I had with Dr. Rainer Engelhardt and Mr. Steven Sternthal, who is the director of the Canadian HIV initiative, it was indicated to me that all four consortiums who had placed bids in this process had received full explanations for why their bids were not accepted in a spirit of complete transparency.

To the best of my knowledge, those full explanations have not been forthcoming. Can you table for us today the detailed explanations that were given to each of these four bidders, or at least tell us if that request has been met, or if that promise has been fulfilled?

[Dr. David Butler-Jones]

As with other bids or with research bids, it would not be appropriate to table what it is. Should they wish to share it with you, that's up to them. But we would keep that in confidence. We don't share that with... We share that with the individual who placed the submission.

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

Fair enough.

[Dr. David Butler-Jones]

Those discussions have taken place, and further discussions will be taking place.

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

It's hard for them to share anything with us if they haven't been given anything. And the promise for full, detailed explanations does not appear to have been fulfilled. When will it be fulfilled? When will each of the four bidders get a detailed explanation of why their bids did not meet the requirements?

[Dr. David Butler-Jones]

They've all had detailed discussions. Whether their perception of it is the same as...that's a different question. But the discussions have taken place with all of them, and they are continuing.

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

So you haven't given a detailed written explanation to any of these four bidders, who put in upwards of $2 million in total to meet the process as set out in 2007.

[Dr. David Butler-Jones]

Our responsibility is to make sure they understand where there were deficiencies for them, and those conversations have taken place. I'm not sure about what was put in writing to them or not, but those discussions have taken place. And as I say, they will continue, as they wish.

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

You don't find it strange that they wouldn't receive detailed written explanations, after such a long and costly process, about why they didn't meet the requirements of the program? You don't find that strange?

[Dr. David Butler-Jones]

They've been told what their deficiencies were.

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

Okay. We'll leave it at that, then.

[Dr. David Butler-Jones]

There's no reason to...because there is no successful bid, and we are not proceeding. It's not like a new bid will make a difference. If there were to be a new bid, the detail would be more, but the detailed discussions are ongoing. They've had high-level discussions, they've had various levels of detail.

Information has been shared with them—

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

Let's leave it at that, because in fact—

[Dr. David Butler-Jones]

—and we'll continue to do so. And that's between the bidder and ourselves.

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

—that is not in the spirit of any kind of transparency and full disclosure that anyone would expect in the field or that was promised and indicated to me was a commitment that was fulfilled by the head of this program and leading scientists at the laboratory in Winnipeg.

Let me go on further to Kirsty Duncan's questioning around the study that has been used as one of the excuses for the termination of these bids. Are you aware of a study that has been done to critique the Gates study? I want to refer specifically to a study done by Don Gerson, who is a leading expert in this field. He has his Ph.D. from McGill, he is a professor of biophysics and biochemical engineering at the University of Western Ontario, he is president and CEO of PnuVax, Inc., and he did, on March 8, a complete analysis of the Gates study, indicating in fact that “this study is fatally flawed by its failure to place priority on the quality aspects of clinical materials manufacturing”.

Are you aware of the importance of good manufacturing practices and what that means in this context?

[Dr. David Butler-Jones]

I am aware, and that is obviously a criterion. Both the Gates Foundation and we are very conscious of the need for quality science, and the assessment was that this was sufficient information. The issue of quality is one that is always there in terms of good manufacturing processes, quality manufacturing processes. That's always going to be there. It's not going to happen without that. The deficiencies in the Canadian proposals relate to that.

It really is something which...for the Gates Foundation and for us, the information is sufficient, given the standard of laboratory practices, given the standards that all the laboratories are expected to provide and to do in terms of good manufacturing processes, that it was not an issue. There will always be an exceptional view, but the general view was clearly that this was sufficient.

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

Given the scientific questions, the questions based on good scientific merits that have been raised about the Gates study, and given the fact that the Gates part of this whole proposal was only $22 million out of the $139 million in total—so only a portion of that against the $88 million for the facility—we're talking about a fairly small contribution in the face of a promise by the Canadian government three years ago to provide a leading-edge production facility in this area.

Given your role as the chief health officer of Canada, are you not questioning at all how this study suddenly emerged under the auspices of the Gates Foundation in July 2009, and are you now not, based on this strong representation by scientists like Dr. Gerson, questioning the process and the study, and in fact sounding the alarms about the entire process? Is it not your obligation—