I'd be happy to outline the current approach. It does demonstrate a contrast with what Vanessa's law hopes to deliver.
As I mentioned in my opening remarks, we do need to recognize, and I fully believe, that Canada does have one of the most rigorous drug approval systems in the world for drugs and medical devices.
This system does ensure, as far as possible, the safety of these products before they're marketed. Before a pharmaceutical product reaches the market it must satisfy strict safety, efficacy, and quality evidence requirements.
Health Canada's team of scientists thoroughly review and evaluate all of the evidence that is provided. Once they've determined that the benefits of the pharmaceutical product outweigh the risks, the department will issue an authorization allowing the pharmaceutical product to be legally available for Canadians to use under specific conditions.
However, and that's where Vanessa's law comes in, once these products are on the market, we currently have limited ability to gather information about these products and to take action when a problem arises.
When Health Canada does issue a market authorization to allow a pharmaceutical product to reach the Canadian market, the department monitors these products to detect any new risks.
This work includes the collection and evaluation of adverse drug reaction reports submitted by industry, patients, caregivers, and health care professionals. We also have a review of periodic safety updates that are submitted by manufacturers, an analysis of information gathered from various sources such as medical and scientific literature, other regulatory agencies internationally, and manufacturers.
You can see that we're doing the best we can possibly do with the powers we have, and that does go quite far, but as many members of the committee know, in the bill before you today there is room for improvement. The scientists and those who work on this issue relish the thought of having more authority and more powers to be able to act in this area.
It was only recently that I announced that Health Canada would start posting summaries of after-market drug safety reviews on its website, which was a great initiative. These reviews provide a plain language description to Canadians with respect to what was assessed, what Health Canada discovered, and what action it took.
This new approach allows the department to share information gathered from the scientific literature, health care professionals, the manufacturers, and other international regulators. These drug safety summary reviews make Health Canada an international leader in the transparent posting of this kind of information, now ahead of both the United States and the European Union.
However, as I've said, Canada's overall safety system for drugs is based on legislation that is over 50 years old now, and lags behind many international regulatory counterparts.
While we've taken action to strengthen post-market drug safety, we still do not have key legislative authorities or tools needed to efficiently further protect the health and safety of Canadians. Vanessa's law will provide us with that. It will provide us with the legal weight to help better protect the health of families.
For example, as we already discussed, adverse drug reactions to pharmaceutical products are estimated to account for one quarter of emergency room visits in our hospitals, and most adverse drug reactions are vastly under-reported.
This is why, as I've said, Vanessa's law includes measures that will require mandatory adverse drug reaction reporting from health care institutions. It will also give our government the tools needed to recall a drug or require a label change.
I will use the example of Diane-35. People ask why this takes so long. Journalists are asking why it is taking so long for us to come out with the action we promised on Diane-35. A lot of it was because we had to negotiate with the manufacturer and that took months.
In this instance, now that we have these authorities, we don't have to negotiate. We were able to take the action we wanted to take on Diane-35. We had a checklist and worked with the associations that were involved with the drug to disseminate very good information to physicians to make sure they were not prescribing Diane-35 off label, and the manufacturer did cooperate with us. It did take us a number of weeks, even months, to be able to reach that point.
That's just one example of why it's important that we have these authorities, so that Health Canada not only has the information but they have the weight, then, to act on it as quickly as possible.
I do think this legislation will make a great deal of difference in the lives of Canadians, but also for the department. They look forward to having these extra tools to do their jobs.