Health committee  I would clarify that the members of CEDAC, our expert advisory committee, are made public, and their biographical sketches and conflict of interest disclosures are available and are on our website. Perhaps what you're referring to are the researchers who develop the reviews for

Health committee  Because, one, the reviews are not disclosed publicly; and two, some of the researchers have actually told us that they would prefer to remain anonymous because they would be subject to lobbying.

Health committee  In terms of the assessment of quality of life, many of the clinical trials that are done with new drugs now include measurements of quality of life that the committee will look at, and that helps in assessment of what's called the cost per quality-adjusted life, which is a freque

Health committee  Currently we make public the recommendations, the key reasons for those recommendations, and a summary of the other information considered by the committee. That document is typically one and a half pages to two pages long. It would provide details concerning the design of the cl

Health committee  It will certainly be more in-depth and more detailed. Right now there is technical information and numbers--i.e., the percentage of patients who respond to a certain therapy, any changes in morbidity, mortality, in percentages--but it's more like an abstract of the study. In futu

Health committee  First of all, it's difficult to agree on what are first-in-class drugs. One of the ways we've tried to analyze this is that manufacturers can submit to us a drug for priority review on clinical grounds. A drug that the manufacturer believes to be available to treat a very serious

Health committee  No.

Health committee  When we looked just at drugs, and defining biologics as those drugs that go through the bureau of biologics at Health Canada, setting aside the expensive drugs for rare diseases, seven out of seventeen biologics were approved through the CDR. Another way of looking at this is to

Health committee  I'm sorry. I don't have information on approval of other countries and their guidelines.

Health committee  One of the things we have initiated in collaboration with Health Canada is the capacity for a CDR to start our review process in the latter stages of the Health Canada review process, so that for those drugs that offer the potential for treatment of life-threatening or very serio

Health committee  —efficiencies in having Health Canada repeat the review that other regulatory agencies have done internationally?

Health committee  I can't speak to that.

Health committee  I'm not sure I can comment. I believe what you're asking is, are there—

Health committee  I'll take the cancer one first. In the first three and some years of the CDR, we've received over 90 submissions, and six of those drugs were for the treatment of cancer. The reason that's relatively low is that most cancer drugs are given by injection, and they're given in canc

Health committee  There was an independent study published in the Provincial Reimbursement Advisor in November that looked at the time taken from Health Canada approval to decision-making by drug plans: pre-CDR it was 471 days, post-CDR it's 479 days. So there really hasn't been any change. Along