Health committee  Thank you. Good morning, everyone. Thank you for having invited me to speak to the committee today. I am pleased to be here to speak to the role Health Canada, as a regulatory body, plays in optimizing the safety of Canada's blood supply. The issue, more specifically, is the r

Health committee  Thank you for the question. The decision to authorize the reduction to one year was based on data that was submitted to us by CBS and Héma-Québec in a submission. We did in fact publish a summary of the research that we reviewed and how we came to the decision. That is on our web

Health committee  It was Canadian Blood Services and Héma-Québec. They have the responsibility to initiate the process to amend their approved conditions. They did that through a submission filing to Health Canada. However, they had been in communication with us well before that point. We had be

Health committee  I'm sorry.

Health committee  To go to the one year, I believe we started discussing that in the previous year, 2015—what would be the data required, what type of information we would need to see—through a series of meetings and then subsequently received the submission.

Health committee  The only two actual requests we've had were for the change from the indefinite to five years in 2013, and then subsequently the change from five-year to one-year earlier this year.

Health committee  I'm sorry. With our safety procedures and regulations...?

Health committee  The regulations for blood in Canada have been completely modernized and updated, and we are very committed to keeping them as updated as they need to be to reflect any changes in technology, so we're quite confident in the strength of our regulatory process. It is very intense. T

Health committee  Certainly. The funding is $3 million for CBS and Héma-Québec, actually, and the use of that funding is to support research into alternatives to the MSM deferral. It would basically be supporting projects focused on examining alternative screening approaches, and also, perhaps, w

Health committee  In addition to regulating the blood supply, we are also responsible for the regulation of pharmaceutical and biologic drugs. I can confirm that there has been a great deal of development in the drug field in products that can be used as alternatives to blood, not just in developi

Health committee  No, but it's equally rigid. There are various aspects of the plasma donation process designed to try to eliminate people who may be there just to collect the small payment. They need to provide proof of a fixed address and things like that. The donor screening and the donor testi

Health committee  Yes, I hope so. I'd like to clarify that plasma donors in Canada are very strictly regulated. Plasma donation is strictly regulated. Plasma donors, whether they are paid or not, go through a very rigid screening process.

Health committee  It's a different situation, because the plasma is processed, and it's actually processed into commercial drugs. There is that whole processing step.

Health committee  Good morning. Thank you for the opportunity to be here today to discuss Health Canada's role in maximizing the quality, safety and effectiveness of drugs for rare diseases and in making these drugs available to Canadians. Joining me today is Dr. John Patrick Stewart, and Ms. Ka

Health committee  I will ask Dr. Stewart to answer that question.