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Health committee  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.

April 13th, 2010Committee meeting

Dr. Rainer Engelhardt

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

April 13th, 2010Committee meeting

Dr. Rainer Engelhardt

Health committee  If it's agreeable with you, I could give just a brief overview of that, because that would give you the chronology.

April 13th, 2010Committee meeting

Dr. Rainer Engelhardt

Health committee  From the perspective of time, if it's agreeable with you, I already mentioned that in April 2008 the invitation for the LOIs, the letters of intent, had gone out. There was a response that we received by June 15—the LOIs from applicants. Then in November of that same year, 2008, four of the applicants were informed that their LOIs were successful, adequate to solicit a full application.

April 13th, 2010Committee meeting

Dr. Rainer Engelhardt

Health committee  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.

April 13th, 2010Committee meeting

Dr. Rainer Engelhardt

Health committee  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.

April 13th, 2010Committee meeting

Dr. Rainer Engelhardt

Health committee  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.

April 13th, 2010Committee meeting

Dr. Rainer Engelhardt

Health committee  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.

April 13th, 2010Committee meeting

Dr. Rainer Engelhardt

Health committee  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.

April 13th, 2010Committee meeting

Dr. Rainer Engelhardt

Health committee  That study, which was provided, was relatively detailed and was one of the factors that related to the very large project. That required interpretation. It required, first of all, assessment of the technical review that was carried out. The technical review was completed only shortly prior to that and hadn't really been evaluated.

April 13th, 2010Committee meeting

Dr. Rainer Engelhardt

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

April 13th, 2010Committee meeting

Dr. Rainer Engelhardt

April 13th, 2010Committee meeting

Dr. Rainer Engelhardt

Health committee  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.

April 13th, 2010Committee meeting

Dr. Rainer Engelhardt

Health committee  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.

April 13th, 2010Committee meeting

Dr. Rainer Engelhardt

Health committee  That decision to cancel the project--in other words, the overall facility--was communicated in February of 2010, this year.

April 13th, 2010Committee meeting

Dr. Rainer Engelhardt