October 21, 2014
Honourable senators, I am very pleased to once again speak to Bill C-17, a bill to protect Canadians from unsafe drugs, also known as Vanessa’s Law.
I was privileged to be a part of the consideration of this legislation in my role as a member of the Standing Senate Committee on Social Affairs, Science and Technology. Our committee had the opportunity to hear from physicians, pharmacists, researchers, academics, drug safety and health law experts, stakeholders such as patient associations and the pharmaceutical industry, and of course Member of Parliament Terence Young and the Minister of Health.
Bill C-17 will bring significant improvements to the health and safety of Canadian families. Vanessa’s Law, if passed, will give the Minister of Health new tools to better respond to drug safety issues such as the power to recall unsafe drugs, impose stiff financial penalties and require mandatory adverse reaction reporting by health care facilities.
Today, I would like to focus on one special population, our children, and the considerations included in Bill C-17.
Any parent who learns that their child is critically ill will tell you that their whole world turns upside down. You forget about work, daily routine, friends and even yourself. Your goal is to ensure that your child gets the best help possible in order to get better. You watch for improvements hour by hour, week by week, and quite often month by month. You spend every ounce of your energy focusing on helping. After all, you want your child to feel better, to go out again to play with friends and go to school. You simply want your child to be happy and healthy again.
As a parent you love and nurture your child through their illness. You may spend countless hours in hospitals and clinics. You get to know the hospital staff well: the doctors, the nurses, the front desk receptionists and even the staff in the hospital’s coffee shop. You build trust in the health care professionals and the treatments they provide. You want the treatments for your child to be the best the system can offer.
Most importantly, you expect the medicines used for your child to be safe and effective. Indeed, honourable senators, let us not forget that this bill is named after one child, Vanessa, who tragically fell victim to an adverse drug reaction.
This is where I want to take a few moments to speak about the provisions proposed in Vanessa’s Law that will strengthen Health Canada’s ability as a regulator. Should Vanessa’s Law be passed, it will ensure that treatments received by children are the most relevant, up to date and based on the most recent safety information about the drug or medical device.
If Bill C-17 is passed it will ensure that our knowledge about the approved drugs and medical devices continues to be gathered not just before but also after they are sold on the market.
In the past, treatment decisions involving the use of drugs in children were often derived from the data in drug studies on adults. However, we know that the safety and effectiveness of medications in children may be significantly different than in adults. Science has determined that children have very different physiology and disease presentation and they metabolize drugs differently.
Therefore, when a pharmaceutical company develops a treatment for pediatric use, it will gather knowledge about that drug before it is approved by Health Canada and sold on the market. In its development, the drug will make its way from bench top to bedside, through laboratory synthesis and, most importantly, through clinical trials.
Currently, clinical trials are a very important source of information. A clinical trial sponsor recruits children across the country, if not the entire continent, in various academic centres and hospitals to study and determine the appropriate use, dose, duration and delivery method of the drug. It also determines situations when the drug should and should not be used in that population. Health Canada then reviews all the results of these tests and studies, and if the product is safe, effective and of high quality, it gives the company a licence to market the drug in Canada for a particular use, in a particular pediatric population, and for a specified treatment duration.
However, once products reach the market, Health Canada’s ability to gather knowledge about them has been limited, as has been the ability to take action when problems arise. When it comes to children and the treatments used, Health Canada must have the same abilities to take action before and after a drug reaches the market.
This is where the new provisions in Bill C-17 come in. If passed, Bill C-17 will give the Minister of Health the ability to set terms and conditions on an authorization and to make the terms and conditions publicly available. This means that, as part of the authorization, Health Canada will be able to ask the pharmaceutical companies to continue to gather information in the real world after the product reaches the market and ensure that Canadians have easy access to this information.
In this circumstance, Health Canada may require the companies to gather information about children with multiple medical conditions. For example, Health Canada may require the companies to look at the effect of a drug in children with impaired kidney function. This information 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 later as we gather real-world experience and see children with that medical condition use the drug.
With this new ability, Health Canada will be able to do more than just issue warning letters. Health Canada will be able to compel the pharmaceutical companies, who benefit from the sale of these drugs, to conduct active safety surveillance among previously unstudied subpopulations or to look at how the product is actually being used in the marketplace.
If passed, Bill C-17 will allow the Minister of Health to compel a label change for the drug and make that information publicly available to Canadians. This means that when there is a safety concern about the drug, the label needs to be updated. With this new ability, such updating will be done immediately, without lengthy negotiations, in order for health care professionals treating children to be aware of the changes being requested and to receive the most recent, up-to-date information.
We know that adverse drug reactions are under-reported, and it is critical that we increase their reporting. Of course, Bill C-17 proposes mandatory reporting of serious adverse drug reactions and medical device incidents by health care institutions. These serious adverse drug reaction reports received from manufactures, health care institutions, health care professionals and the public are often the first sign of emerging safety issues related to a drug.
Bill C-17 will mandate Health Canada to take quick action and transfer this knowledge to other health care professionals and Canadians in order to prevent further harm and tragic consequences from occurring to another child who may be on the same drug.
These are just some of the new provisions proposed in Vanessa’s Law which will ensure our knowledge about approved drugs and medical devices continues to be gathered not just before but also after they are sold on the market.
Honourable senators, thank you for giving me the opportunity to speak yet again on some of the benefits of Bill C-17 and how this legislation will improve patient safety and positively impact Canadians and their families. It has been an honour and a privilege to be a part of this landmark legislation in pursuit of a health system that is both safe and effective for Canadian families.
I know that all honourable senators will join in my thanks to Member of Parliament Terence Young and the Honourable Minister Ambrose for bringing this legislation before us. Thank you.