Mr. Speaker, Canadians want to know that when they are prescribed a medication, it has been rigorously reviewed by one of the most exacting safety regulators in the world. They also want to know about any new facts as soon as possible after they emerge so they can continue to make informed decisions in discussion with their health care providers. That is why the new authority in Vanessa's law regarding mandatory label changes is so important.
The thalidomide tragedy made us all aware that drugs are powerful chemical or biological substances and that while these can provide many benefits, they also have the potential to have unwanted side effects. Sometimes these side effects are serious enough to be life-threatening, permanently debilitating and, in rare, instances even fatal.
Health care institutions are uniquely positioned to identify and report these serious adverse reactions. Although most drugs are prescribed by a family doctor and used outside of a hospital setting, the most serious side effects result in patient hospitalization. As a result, adverse reaction reports serve as an important source of safety information. However, to date, adverse drug reactions have been under-reported.
That is why, with the new authorities provided in Vanessa's law, Health Canada will be working with provinces to develop a system for health care institutions to report serious adverse drug reactions and medical incidents directly to the department and to ensure the department provides critical and timely feedback to health care providers about the adverse reaction reports it receives.
With the passage of Vanessa's law, the minister will have new regulatory tools to draw upon when the possibility of an unforeseen serious risk has been identified. The minister can now order a label change or a recall. Once the relevant provisions are enforced, the minister will also be able to order new tests or studies on the product, ongoing monitoring of the product's use, or a thorough reassessment of existing evidence about the product.
It is also important to note that the minister has multiple ways of addressing a safety risk to the public that do not necessarily involve removing it from the market. It is important to keep in mind that any time a drug is pulled from the market, it can have significant consequences on patients who may rely on that drug to treat serious and debilitating conditions.
Vanessa's law has introduced tougher measures for those who do not comply with the Food and Drugs Act. The maximum fine has been increased to $5 million and/or two years in prison. In addition, courts will have the discretion to impose even higher fines if they determine that a person has knowingly and recklessly endangered human health. This sends a strong message that marketing unsafe drugs in Canada is completely unacceptable. Unfortunately, there are always a few who choose to engage in unethical behaviour. That is why the higher penalties that Vanessa's law have introduced are vital.
The large number of changes recently introduced by this new legislation have the potential to greatly enhance patient safety in Canada and to demonstrate how our health system is continuously evolving to better protect Canadians and keep pace with scientific knowledge. They reflect our determination as parliamentarians to reduce the risk of tragic events of the early 1960s ever occurring again.
We have learned from the experience of thalidomide and we are pleased to support the motion before the House today.