Health committee  Not medical records.

Health committee  I think she wants me to take that, too.

Health committee  First of all, we want to acknowledge Mr. Shepherd's testimony as well, because it's bringing forward information from individual cases on which we can base early signals and trends to start doing research. In answer to your basic question, there really isn't good information collected in the literature to date that would support any ban on energy drinks based on intoxication, dependence, or those kinds of things.

Health committee  Vaccine surveillance is done by the Public Health Agency of Canada, but they then liaise, in this situation, with the biologics and genetic therapies directorate in our branch, so they're--

Health committee  No, as I said, the monitoring activity my directorate does is not responsible for vaccines. That's monitored by the Public Health Agency. So I can't speak to whether or not they're aware of this at this point, but I would suggest--

Health committee  One of my directors from our area who is monitoring pharmaceuticals has just advised me the EMEA in Europe has issued a risk communication on this issue, so there is an awareness of it. But as I said, we're not primarily responsible for the monitoring of adverse effects for vaccines, so we wouldn't be responsible for that.

Health committee  There is a toll-free phone and fax line, and soon there will be postage-free mail-ins. If they are Internet savvy, there is also an online reporting form.

Health committee  It's widely advertised. MedEffect promotes it. MedEffect is linked through some 400 other sources, so there are those sorts of electronic outreaches. As well, it's advertised in various professional journals. And a lot of our consumer group partners also promote the access with their patient groups in their publications.

Health committee  They're primarily responsible for two big jobs. The first is to collect and process the initial adverse reaction report from their local area. Second is to promote and encourage reporting in the area. A third one is perhaps encouraging appropriate use of adverse reaction information, because people tend to abuse it, for example the media, which tends to sensationalize it and scare Canadians away from using products that may actually be beneficial to them.

Health committee  I think what you're raising is that information can come to us from a variety of sources. For example, today there is a report of a Quebec citizen who had a fatal reaction to taking excessive doses of cold medications. We don't limit the investigation or the creation of a report to someone actually sending us a report by fax—and we have toll-free fax and phone lines--by the online electronic reporting, etc.

Health committee  The definitions of adverse reaction and serious adverse reaction are in the regulations. A serious adverse reaction does involve hospitalization, but it involves several other things as well: if there is a life-threatening reaction; a death, obviously; a disability; or a congenital anomaly.

Health committee  By accumulating them. We have other approaches. For example, we're working with groups such as the Canadian Medical Association and the Canadian Institute for Health Information in terms of hopefully, in the nearer future, being able to leverage reports without relying on, or waiting for there to be, a voluntary report.

Health committee  Sure.

Health committee  As part of the workup for this issue—and this again is something that was discussed with the previous Standing Committee on Health—we have done an international survey of foreign regulatory action, and what we've found is that there are a certain number of countries that do have mandatory reporting requirements for health professionals, but what we've also been told by them and what the evidence shows is that those requirements for mandatory reporting by individual health professionals have increased neither the quality nor quantity of adverse reaction reports.

Health committee  I would add that one of the interesting aspects of the developing science around post-market surveillance is that it is evolving. You asked whether some of this work done before. It wasn't, because the tool to do it was not there. I have a three-page report, which we could leave with the committee, that talks about what our regulatory partners are able to do in their jurisdictions.