Mr. Speaker, I first want to congratulate the member for Oshawa on his very thoughtful remarks. We are certainly fortunate to have a parliamentary secretary who is so engaged on the topic.

It is impossible to stand today to speak about the thalidomide tragedy and not be moved. It is a story of an unspeakable tragedy of distraught parents, and children born with challenges that most of us cannot begin to comprehend. This is a tragic event from the 1960s that reminds us of why we need to take drug safety so seriously.

Nothing could ever undo the pain and suffering that was inflicted. It is a story that changed the way we regulate drugs in Canada. It opened our eyes to the fact that while drugs can bring many benefits, by curing diseases, reducing symptoms, and prolonging lives, they can also carry tremendous risks. It also serves as a constant reminder that we as parliamentarians must do all that we can to strengthen patient safety in Canada. That is why I am very pleased to hear that the Minister of Health will be meeting with thalidomide victims and working co-operatively with them to determine what government can do to support them.

Canada now has one of the safest drug systems in the world, and our government recently strengthened that even further, giving royal assent to Bill C-17, Vanessa's law. Protecting patients is a shared responsibility, one that also rests with fellow legislators in the provinces and with provincial health departments, individual health care professionals and administrators, the colleges that regulate medical practice and other professional organizations, key partners like the Canadian Patient Safety Institute, and the Drug Safety and Effectiveness Network, and last, of course, the manufacturers of drugs.

The thalidomide tragedy of the 1960s, like no other event before or since, has impressed upon us what a truly enormous responsibility that is. While the quest for new cures is vital, it is equally important that we do everything in our power to ensure that drugs that reach the market do not cause harms that outweigh their benefits. That is why all parties in the House and in the other place united to unanimously support Vanessa's law, and why so many stakeholders and individuals endorsed that legislation.

Although many steps have been taken previously to strengthen Canada's drug safety system, we all recognize that the Minister of Health and Health Canada did not have adequate powers to protect patients from drugs that were found to be unsafe once they were on the market We, as legislators, acted decisively to provide the new tools to address this gap.

I would like to take some time today to focus on how Vanessa's law will enhance patient safety, how it will reduce the risk of tragic events like those associated with thalidomide, and how it will help Canadians to make informed decisions about the drugs they are taking.

Vanessa's law will ensure that knowledge about approved drugs and medical devices continues to be gathered and shared with the public once products enter the market. This is important because clinical trials can only tell us about how a drug will affect a particular population, the population it was tested on. They do not tell us how the drug will affect everyone who might take it once it is on the market.

When a company submits an application for market authorization to Health Canada, reviewers analyze the results of all tests and studies that are submitted. If the product is safe, effective, and of high quality, the department will give the company a licence to market a drug in Canada for a particular use. However, once products reach the market, Health Canada's ability to gather knowledge about them has traditionally been limited, and its ability to take action when problems arise has also been limited. That is why there are new provisions in Vanessa's law that represent a game changer.

Let me take a moment to describe some of them and why Vanessa's law is so crucial. One important new provision is that Vanessa's law will give the Minister of Health the ability to set the terms and conditions on an authorization and to make those terms and conditions publicly available. What this means is that, as part of the authorization, Health Canada will be able to ask a pharmaceutical company to continue to gather information in the real world, after the product reaches the market, and to make the results of the information gathering public so that Canadians and their health care providers have easy access to them.

For example, Health Canada may require the company to gather information about the impacts of a drug on patients with multiple medical conditions. Health Canada could require a company to monitor and assess the effects of drugs on patients with impaired kidney function. This may or may not have been studied in the initial clinical trial, and the approved label would indicate that.

However, this information may prove to be important as we gather real-world experience and see some patients with impaired kidney function and how the drug affects them. It may become apparent that there is no difference in the benefits and harms experienced by patients with impaired kidney function.

However, should it become clear that there may be a cause for concern, Health Canada will be able to compel the manufacturer to conduct active safety surveillance or conduct a new study specifically to address the issue. The information about what activities the manufacturers are being compelled to undertake will be made public. It will be a transparent system so that prescribers and patients will know what actions are being taken. Vanessa's law also provides the Minister of Health with the power to compel a label change for a drug and to make that information publicly available to Canadians. In the past, most companies have agreed on a voluntary basis to undertake a label change. Sometimes, however, protracted negotiations have been required, and sometimes, those negotiations were not successful. The new powers provided by Vanessa's law have changed that, so if adults or children are taking a drug, they will be able to access this new information. This will allow us, as Canadians, to make informed decisions in consultation with our health care providers.

However, not all new information comes from tests, studies, or the ongoing proactive monitoring of a drug. Sometimes, adverse events are completely unexpected and only identified through a rigorous adverse drug reaction reporting system. This reflects the reality I mentioned before, that patient safety is a shared responsibility. That is why Vanessa's law included mandatory reporting of serious adverse drug reactions and medical device incidents by health care institutions. Simply put, serious adverse drug reaction reports from manufacturers, health care institutions, health care professionals, and the public often provide the first clue about an emerging drug safety issue.

To date, adverse drug reactions have been under-reported in Canada. It has only been mandatory for companies to report adverse drug reactions related to their products. It was recognized that it is critical that we increase the reporting of adverse drug reactions so that Health Canada could take quick action when a problem is detected and share the knowledge rapidly with health care professionals and, most importantly, the public, in order to prevent further harm.

Sometimes, it may be necessary to remove a drug or particular batch of the drug from the market. Other times, it may be appropriate to change the label of a drug so that health care practitioners are aware of the new information when they make their prescribing decisions. In other situations, it may be most appropriate to require the company to conduct some active monitoring to gather further information.

I mentioned earlier the important work done by the Canadian Patient Safety Institute and the Drug Safety and Effectiveness Network. The Canadian Patient Safety Institute works with governments, health organizations, leaders, and health care providers to inspire improvements in patient safety and quality care. It acts as an advocate and catalyst for improvements in patient safety, and it invests in and brokers policy and system changes to protect the health of Canadian patients. As Health Canada works to roll out the new authorities provided in Vanessa's law, either immediately or through developing regulations, these organizations will be able to provide advice.

Nothing can undo the pain and suffering endured by the thalidomide survivors and their families, and it is truly tragic. However, with the passing of Vanessa's law, federal regulators have important new tools to enhance on-market drug safety. The legislation is a very real step to reducing the risk that similar tragedies will occur in the future, and it represents a very important federal contribution to the shared goal of patient safety in Canada.

Patrick Brown

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