Mr. Speaker, I will be splitting my time today with my colleague, the member for Huron—Bruce.

I want to begin by saying that nobody who is not a thalidomide survivor or a relative or a friend of a survivor can begin to comprehend the pain and suffering the thalidomide tragedy caused. Nothing can ever undo the pain and suffering inflicted. It is a tragedy that made governments around the world fundamentally rethink how they protect their citizens' health and safety.

The government in Canada too learned from this tragedy. The tragic event from the 1960s reminds us why we need to take drug safety so seriously. Since that time, we have collectively resolved that Canadians deserve nothing less than one of the safest drug approval systems in the world.

As parliamentarians, we continue to strive to strengthen patient safety in this country. We continue to make changes to the drug safety system to enhance its rigour and reduce the risk that this kind of terrible event could occur again. That is why this House so recently united to support Bill C-17, Vanessa's law. It is too often that we experience terrible events like the impact of thalidomide from its use in the early 1960s and, more recently, the death of Vanessa Young to call us to action.

In the case of Vanessa's law, all parliamentarians recognized Health Canada's need for appropriate authorities to ensure that unsafe products are identified and dealt with quickly. We recognized how important it is for regulators to be given the tools they need to protect Canadians from unsafe drugs.

In the wake of the thalidomide tragedy, laws were enacted to require manufacturers to file more detailed submissions with Health Canada, the federal regulator, to receive authorization before a new drug could be marketed. These submissions contain substantial information and data about the drug's safety, effectiveness, and quality, as well as warnings and precautions about side effects.

Products with an identified risk, such as the potential to cause birth defects, or products that are used in vulnerable populations, such as children or pregnant women, are treated as high-risk products and are subject to increased scrutiny, monitoring, and risk mitigation.

These were critical changes to the drug safety system; however, it became apparent that addressing safety concerns at the pre-market stage was not enough. Health Canada needed the tools to take appropriate action if a serious risk was identified after a drug was on the market. That is why all parties in this House and in the other place endorsed Vanessa's law, which received royal assent on November 6 of this year.

This legislation will protect Canadian families and children from unsafe medicine by enabling the Minister of Health to require health care institutions to report serious adverse drug reactions and to report incidents related to medical devices, to recall unsafe products, to apply to the courts to impose tough new penalties for unsafe products, to provide the courts with discretion to impose even stronger fines if violations were caused intentionally, to compel drug companies to revise labels to clearly reflect health risk information, and, finally, to compel drug companies to do further testing on a product, including when issues were identified with certain at-risk populations.

Vanessa's law has also introduced new transparency measures that when in force will require Health Canada to make both positive and negative regulatory decisions publicly available, as well as the reasons for those decisions. These reasons will include a clear statement of benefits a drug may confer, the harmful side effects that some patients may experience, and areas where there are gaps in knowledge.

Transparency regulations will enhance the current transparency requirements in Bill C-17 by placing an obligation on drug companies to disclose more clinical trial information publicly.

Canadians will also be consulted during the regulatory development process about the types of information that could be made available.

As an example, clinical databases show what clinical trials are taking place in Canada for drugs that treat a particular disease or condition. They also provide information about a point person who can provide information for that particular clinical trial. Going forward, a clinical trial registry could indicate whether a trial has been conducted or if it has been terminated prematurely. At the conclusion of a trial, a registry could provide a summary of the results.

The information could be important to patients and health care providers in making treatment decisions. It could be helpful to academic researchers in doing further assessments relating to patient safety. It could stimulate thinking about new areas for research.

In developing Vanessa's law, the government consulted broadly with patients and experts about how to best update Canada's drug safety laws. The new measures substantially strengthen the safety and oversight of therapeutic products throughout their life cycle. They improve Health Canada's ability to collect post-market safety information and ensure strong and active oversight once a drug is on the market. Equally important, they improve the department's ability to communicate important safety information to Canadians and their health care providers.

I will continue my remarks after question period.

Costas Menegakis

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