Health committee  I cannot comment. The only thing is that “Dear health care professional” letters are accompanied as well by public advisories on the Health Canada website. So again, in terms of transparency, we are not just communicating this information through Health Canada. Health Canada wi

Health committee  When those risks are well established and there is consensus about those risks, the labelling goes on to the extent that you even have what is called a framed warning. So it's very clear in the labelling what the major risks are. If you look at the labelling of some drugs, espec

Health committee  But the labelling was correct. The labelling was correct.

Health committee  I can certainly comment on the fact that some of these instances have shown that adverse events can occur after a number of years. And the post-marketing effort that Health Canada is trying to regulate in a more structured manner takes care of the recognition that side effects so

Health committee  There have been recent cases of market withdrawal when the information, for example, originated in Australia, and that information was communicated by the manufacturer to Health Canada, and there was an agreement between the manufacturer and Health Canada to withdraw the product.

Health committee  We are doing that.

Health committee  Yes. We encourage the approach, as I mentioned earlier, through progressive licensing. One area where again we should be cognizant, because the resources are limited and the data necessarily has to be large, is that we need to ensure that whatever we do will be Canadian regulat

Health committee  The length of a study varies depending on the disease. I think there are obviously international standards with respect to the length of a study. To demonstrate the efficacy of a product you don't necessarily have to test the product for a year. However, certainly for safety, stu

Health committee  The only thing I can say, again, is that virtually all studies are subject to regulatory scrutiny. There's the editorial policy of a journal. You could submit a study to a journal and be refused publication. So I do not believe there is an intentional attempt not to disclose neg

Health committee  Yes. I believe that progressive licensing will also help the manufacturer to know exactly what the requirements or the standards are that TPD expects. We certainly encourage, as I mentioned, the harmonization of the standards, recognizing that the Canadian population is a small o

Health committee  I don't know. Every study is different, depending on the number of patients. But they are expensive in terms of the resources. Also, at the sides you have to have expert people within the company. You have epidemiologists. You have groups of people looking at the signals that mig

Health committee  All studies, as I mentioned, will be registered through public databases. The quality of those studies is discussed with the regulatory agencies and is reviewed by ethics advisory boards. So there are at least two levels of scrutiny with respect to the scientific methodology and

Health committee  The progressive licensing framework is an attempt by Health Canada to address the issue of updating the regulations and to be in line with the way new pharmaceutical products now are being developed. There is an awareness, obviously, that there are some limitations, as I mentione

Health committee  The treating physician should be reporting that event.

Health committee  At the present time, it's not obligatory.