Mr. Speaker, it is an honour and a pleasure for me today to stand to support and talk to the House about Vanessa's law.
As my colleague from Okanagan—Coquihalla mentioned, this bill requires the reporting of serious adverse drug reactions to ensure that doctors and patients are aware of new risks, and introduces new tough fines for companies that put Canadians at risk. I encourage all members to support the bill's referral to committee so some progress can made on the important issue of drug safety and work toward better protections for Canadian patients.
I will focus my remarks on the importance of mandatory reporting of serious adverse drug reactions and also medical device incidents by health care institutions and how this would improve our ability to respond to safety issues that would help keep Canadians safe.
As members of the House can appreciate, drugs can not only have beneficial effects for patients, but can sometimes have unintended and unwanted side effects. These side effects, better known as adverse drug reactions, can sometimes represent very serious medical risks. What are termed serious adverse drug reactions in the bill are ones that require hospitalization and are often life threatening or result in permanent disability.
Adverse reactions to medications are estimated to amount up to 25% of emergency room visits and hospital admissions, an amazing number that would likely shock most of us. That is why I find it so appropriate that the bill has been entitled Vanessa's law, in memory of the member for Oakville's late daughter, who tragically died of a heart attack while on prescription drugs that were later deemed not safe and then removed from the market.
The bill would make it a requirement for certain health care institutions to provide Health Canada with serious adverse drug reactions or medical device incidents. This information would allow Health Canada to take steps to prevent further harm related to these products. As I mentioned, although a significant number of Canadians are admitted to hospitals each year for serious drug reactions, again 25%, this important information about drugs and medical devices does not always reach Health Canada. This is a serious concern and one that legislators can actually help address.
Our country has one of the most rigorous drug approval systems in the world. Before a drug reaches the marketplace, the department reviews it for safety, quality and effectiveness. This review is generally based on scientific data that is attained through previous studies and observed in clinical testing.
Clinical testing is an important part in the development of drugs and medical devices, and we have every reason to have the confidence in the science. However, studying drugs before they are put on the market cannot tell us everything about these products. When a drug or medical device is introduced to the real world, it may produce different results from those that were observed in a controlled clinical trial setting. In fact, some serious issues may only become known after a medical device or drug is actually on the market.
It is therefore critical that we continue to monitor the use of drugs and medical devices in the marketplace and that information on serious adverse reactions are reported to Health Canada in a timely manner. Under current law, and this is interesting, only manufacturers and sponsors of clinical trials must report serious adverse reactions. However, they do not receive reports on some of the serious adverse reactions and cannot report incidents to the department if they do not know about them.
I will give credit where credit is due. Adverse drug reactions reported to Health Canada have been on the rise over the past five years. Unfortunately, despite these improvements, it is estimated that less than 10% of adverse drug reactions are actually reported. This underreporting of important safety information is a serious concern as it limits Health Canada's ability to identify at an early stage the potential safety issues with a product and to take timely action to prevent additional patient harm.
Some positive steps have already been taken to address underreporting by educating health care professionals on the value of reporting and how to properly report to Health Canada. Pre-emptive steps have also been taken to introduce new simplified forms and electronic forms to report. Devoting health care resources needlessly to an overly complex system creates a problem in itself and nipping this in the bud is simply good policy. In addition, Health Canada has worked with standard-setting bodies such as Accreditation Canada to assist health care institutions to standardize their process for reporting. Although this has helped, it is still not enough. We need to do better.
With Vanessa's Law, we will strengthen serious adverse drug reaction and medical device incident reporting, as well as provide the tools needed to respond to unsafe drugs.
Let me give a few examples to illustrate how this safety information can benefit patients and how the bill would support these measures.
When Health Canada receives important information about a certain medical device or drug, it will take the necessary steps to prevent future harm. Health Canada could alert health care professionals to any new harms and how they could be mitigated, or require the manufacturer to change the labelling to add a warning.
We know that many serious adverse drug reactions are preventable. Taking action to prevent these harms will free up valuable hospital resources, through addressing threats to health and safety before hospitalization is required.
As alluded to earlier, we are well aware of how busy health care institutions have become and we do not intend to impose any unnecessary burden on an already strained health care system. That is why we are strongly committed to further consultations with health care institutions, as well as with provincial and territorial governments.
There is a clear commitment in the bill to developing regulations that will set out what information is required, how it is reported and which health care institutions will be required to report.
Only those health care institutions that are best positioned to improve the quantity and quality of reporting would be required to report. Only useful safety information about a drug or medical device will be gathered in ways that are efficient and within time frames that are meaningful. Again, all with a view to ensure the least burdensome way to get the safety information that is needed.
Further, it is an expressed commitment in the bill that reported requirements will take into account existing information management systems with the view to not imposing any unnecessary administrative burden. This will lead to the development of a meaningful reporting system that is not only focused on increasing the quantity of data, but also in gathering quality data.
It is important for Health Canada to continue to monitor drugs and medical devices once they are on the market. The information that health care institutions will provide on serious adverse drug reactions will allow Health Canada to assess the balance between the benefits and the risks of a drug while it is on the market. More important, it will support timely identification of safety issues and early action to prevent future harm.
Our government's priority is the health and safety of Canadians families. Strengthening the reporting requirements for drugs and medical devices will better protect Canadians and their families from preventable harm.
These important measures need to be taken, and I hope Vanessa's Law will receive support from all parties so that all of us as a country can take action for better protection of Canadians.
I am thankful for the time allotted for me to speak to such an important bill and I look forward to questions.