Evidence of meeting #26 for Health in the 39th Parliament, 2nd Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was information.
A recording is available from Parliament.
Liberal
Director, Marketed Pharmaceuticals and Medical Devices Bureau, Marketed Health Products Directorate, Health Products and Food Branch, Department of Health
The Canadian Adverse Reaction Newsletter is published every three months, so it's quarterly.
Liberal
Lui Temelkovski Liberal Oak Ridges—Markham, ON
It's quarterly. We're familiar with those, because we send something out to the community on a quarterly basis.
Director, Marketed Pharmaceuticals and Medical Devices Bureau, Marketed Health Products Directorate, Health Products and Food Branch, Department of Health
Maybe I can add some information about its distribution.
That newsletter is distributed to 67,000 physicians in conjunction with the Canadian Medical Association Journal. It's also printed and distributed to an additional 26,000 health care professionals, mostly pharmacists. It's also sent to all the professional associations of pharmacists and physicians in Canada so that they can send it back to their members.
There's also the MedEffect e-Notice, which is basically a site where people can register or be subscribers and then be informed of all the emerging safety issues in Canada, which also includes publication of the CARN.
Liberal
Lui Temelkovski Liberal Oak Ridges—Markham, ON
Is the EU, the European Union, using a progressive licensing system?
Director, Office of Patented Medicines and Liaison, Therapeutic Products Directorate, Department of Health
They are certainly using a life cycle oversight model, and that's really what progressive licensing was intended to convey--that you're progressing over time in your knowledge about the therapy. In fact, we've done a lot of studying with the Europeans, because we think they've advanced a lot of this very well. They are a very good model to look to.
Liberal
Lui Temelkovski Liberal Oak Ridges—Markham, ON
If we are aggressive in reporting adverse reactions, and the most aggressive we've been is 10% so far--that's what we've heard--should we move away from the current proposed adverse reaction system and put our money or our resources into something like what Dr. Carleton is suggesting, or should they run concurrently with one another?
Dr. Carleton, maybe you could answer.
Senior Clinician Scientist, Child and Family Research Institute, BC Children's Hospital, University of British Columbia
At the risk of offending my colleagues to the right--I'm just teasing--of course the work we're doing needs more funding, and there is opportunity to use both a spontaneous reporting system and a targeted surveillance system to identify drug reactions of concern and, most importantly, solutions to these problems.
I feel that we talk a lot about identifying the reactions--identifying reactions, getting reports. It's not enough. We don't report as doctors, as nurses, as pharmacists--even as consumers--because, what is it? At the end of the day, it's a report. It's sent to Health Canada, and no one is quite sure how this is going to be used to improve the safe use of medication for the very next patient who comes to the hospital or into a medical practice environment. We need solutions, and that's what I think needs to be part of this.
I agree with a progressive product life cycle approach for advancing our understanding of drugs over time, but it has to be directed at improving safety. It has to be directed at that. There have to be solutions identified now, a priori, that we will seek to actually embed into the practice of health care so that we'll no longer just be reporting for reporting's sake.
Conservative
Conservative
Patrick Brown Conservative Barrie, ON
Thank you, Madam Chair.
I wanted to probe the topic of off-label use in Canada. Could you share with us some information on how frequent it is and whether Health Canada has concerns about it?
We've heard terms like “drug cocktails” in relation to treatments for cancer and AIDS and other new or complex diseases. We've also read information that off-label use is more frequent with rare diseases and also that there's a greater frequency of off-label use when it comes to pediatrics. Could Health Canada share with us a little more description of off-label use and any concerns you may have regarding it?
Director, Marketed Pharmaceuticals and Medical Devices Bureau, Marketed Health Products Directorate, Health Products and Food Branch, Department of Health
Thank you for your question.
Off-label use of a therapeutic product is basically when a product is used outside of the approved product labelling. It might be a different dosage or different route of administration, or outside of the indication for which the drug was initially approved.
The issue of off-label use is partially under the control of the physician. Sometimes it's the practice of medicine to use drugs outside of their recommended indications. The control or oversight of such off-label practice mostly resides with the provincial colleges of pharmacists and physicians who regulate the activities of their members.
In Canada it does happen sometimes, of course, in the pediatric population. There is some off-label use occurring there due to the fact that often there is a therapeutic need to handle some medical conditions. As well, there is not necessarily a solid body of knowledge that has been routed through the regulatory authorities and approved to basically grant an indication. Off-label use occurs also in certain subpopulations, such as cancer patients and AIDS patients. As I said, it's a reality that basically involves the practice of medicine.
We do, as a regulator, take action when we are aware of an off-label use that generates safety concerns, but we cannot regulate off-label use; it's outside the scope of our authority. As I said, it falls within the competencies of the different professional associations in Canada.
Conservative
Patrick Brown Conservative Barrie, ON
Do you find there's a greater risk for adverse reactions in those scenarios?
Director, Marketed Pharmaceuticals and Medical Devices Bureau, Marketed Health Products Directorate, Health Products and Food Branch, Department of Health
It's difficult to assess, because there is no evidence. Basically, the challenge around off-label use is that the drug use is not supported by the same thorough evaluation. You are right, yes, that there is a risk of adverse events for off-label use, as there is for approved use. It would be very difficult to assess if there were more.
Conservative
Director, Marketed Pharmaceuticals and Medical Devices Bureau, Marketed Health Products Directorate, Health Products and Food Branch, Department of Health
Yes, they are. When there is a report for an adverse drug reaction, that report is not related to whether the drug was used within the approved indication or off-label.
It's also interesting that internationally and also in Canada we are moving to a life cycle approach. Basically, the concept is that more and more drug manufacturers will be expected, at the time of approval, to submit information about potential off-label use, whether it's in pediatrics or other subpopulations, and to document or to monitor such off-label use.
In the life cycle approach, the thinking behind it--the same thinking is present also in Europe, for example, where they use the risk management plan--is that whenever you submit a drug, you also have to assess the potential for off-label use, monitor that off-label use, and report that to the regulatory authorities.
Conservative
Patrick Brown Conservative Barrie, ON
When we hear the term “drug cocktail”, such as for complexities like AIDS and cancer, what is meant by that term, and--
Conservative
The Chair Conservative Joy Smith
Mr. Brown, I'm sorry to interrupt you, but you're over your time.
Madame Gagnon.
Bloc
Christiane Gagnon Bloc Québec, QC
I have been given some information on Gardasil and I have not had the time to read it. I would have liked to ask you some questions about it.
According to the notes provided by the Parliamentary Information and Research Service, progressive licensing makes sense, but, in the United States, it is less effective than anticipated and that pharmaceutical firms often fail to comply, that is, they do not do, or complete, the required studies. In fact, a number of studies on several products were not even started. Further, the report goes on to say that the FDA does not have the authority to take direct legal action against violators.
What approach could Canada take in order not to find itself in the same situation? What would you do to bring pharmaceutical companies into line more forcefully and to make lawsuits possible? If we adopt the progressive licensing approach, will we have that kind of recourse?
Director, Office of Patented Medicines and Liaison, Therapeutic Products Directorate, Department of Health
First of all, there are perhaps several misunderstandings around the term “progressive licensing”, which was not intended to mean, in our view, the same thing as moving drugs out earlier.
What we meant by that is that we really want to make sure that as our knowledge about a drug grows over time, we take the best advantage of that information. There is a traditional way of doing pre-market studies, and we didn't want to change that. However, in the United States there are ways by which a handful of drugs can come out “earlier”, meaning earlier in the pre-market study phase. Proportionally, in Canada, we've looked at 32 drugs that way, as compared with the 9,000 generally marketed; and those drugs were for very small populations, where people usually have an unmet medical need, so it's very narrowly confined.
The experience in the United States has really been to make sure that people follow up on studies. We've tried to explore this concept very responsibly, because people in these situations who are taking these therapies need to know the context they're in and that the study can be completed. Europe also has models they're working on in this respect.
So it's how you take responsibility for that handful of drugs—and these are not the general market authorizations that we would see in the life cycle for most drugs. In fact, for the vast majority of drugs there's no change in the pre-market data required. It's just for this very small handful.
Then the question you're going to is that you really want to make sure these commitments are met. So as we've been thinking this through and talking to many groups, there's a very strong insistence that.... For example, the provinces have told us that they want to see most issues resolved, that we have to deal with this responsibly. So again, making sure these commitments are followed up has been a very serious policy that we've looked at extensively.
Bloc
Christiane Gagnon Bloc Québec, QC
A number of witnesses have told us that we need an independent body to do independent testing, both pre-market and during a product's life-cycle.
The Marketed Health Products Directorate, the MHPD, seems to be conducting this kind of testing. They are a branch of the department. According to your presentation, the MHPD is a body that conducts independent tests and ensures that standards and regulations are consistent. But witnesses have told us that there is no independent body and that we need to create one.
How do you respond to that request? What do you think of the testing? Is it really independent?
Conservative
The Chair Conservative Joy Smith
I'm sorry to interrupt you, but we're going to have to get some answers. We only have about 20 seconds left, so could you please—
Director, Marketed Pharmaceuticals and Medical Devices Bureau, Marketed Health Products Directorate, Health Products and Food Branch, Department of Health
The concept of independence comes from the fact that it is a different group doing the follow-up on the medications after they are put on the market. Witnesses have told you that the MHPD was not well known and that people in the directorate should be told to look at medications differently. But there is collaboration and discussion.
Some witnesses have also said that there is room for independent research in Canada. A number of centres in Canada have expertise in this area. There are different ways to conduct independent research.
The MHPD, which was set up in 2002, had, as one of its goals, to allocate resources to the surveillance of drugs after they are put on the market so that they are tested again. This model has been proposed in the United States. I feel that Canada played a leadership role when it set up the MHPD.
Conservative
Conservative
Patricia Davidson Conservative Sarnia—Lambton, ON
Thank you, Madam Chair.
I have just a couple of quick questions.
When Mr. Brown asked about the off-label use, did I understand correctly that you said the provinces and territories have the responsibility for regulating the practice of health care professionals through the colleges of physicians?
Director, Marketed Pharmaceuticals and Medical Devices Bureau, Marketed Health Products Directorate, Health Products and Food Branch, Department of Health
Yes. The main responsibility is under the professional associations, which are provincially based.