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.
Conservative
Patricia Davidson Conservative Sarnia—Lambton, ON
All right. So the practice of the health care professionals plays a part, then, in the off-label use. Is that your inference?
Director, Marketed Pharmaceuticals and Medical Devices Bureau, Marketed Health Products Directorate, Health Products and Food Branch, Department of Health
When a drug is used off-label, it's because a physician makes a decision in a specific patient when this drug would be, on a population level, contraindicated. Maybe because that patient is allergic to other available therapies or has not tolerated the other available therapies, the physician might make the decision to use that drug in that specific patient, outside the approved indication. That doesn't mean there is no medical rationale behind it, but just that it's outside what has been approved on a population basis.
Conservative
Patricia Davidson Conservative Sarnia—Lambton, ON
We're talking about the life cycle approach for drugs. If that happens, will the benefits of the off-label uses be recorded? Right now, I think only adverse effects are recorded. Will this help expand the label use?
Director, Office of Patented Medicines and Liaison, Therapeutic Products Directorate, Department of Health
That would be the intention of the policies we have been trying to develop. You are correct that there is a long-standing obligation on manufacturers to report an adverse drug reaction no matter how it's used, whether it's used, as Marc pointed out, off-label or not. But the intention is to make sure that...all the information you are losing on a population basis. You can use them one by one, but as that adds up in a community of use, you really want to study what's going on there, if you can. That's where the life cycle tools could be introduced, so that you can have varying types of studies, depending on what's really needed either clinically or on the population level.
Conservative
Patricia Davidson Conservative Sarnia—Lambton, ON
So the intent is to look at the beneficial side of things, as well as the adverse side.
Director, Office of Patented Medicines and Liaison, Therapeutic Products Directorate, Department of Health
Yes. It's both benefits and risks, and we want to keep those concepts really quite close together.
Conservative
Patricia Davidson Conservative Sarnia—Lambton, ON
Mr. Fraser, are there things that you can see we should be recommending that would improve recording and information back and forth between the provinces and the federal government?
Director, Drug Program Services Branch, Ontario Ministry of Health and Long-Term Care
I think one of the key things that our experts are requesting in terms of information is the timeliness of the information. For example, if a safety event has been reported, whether it's in the press or in another jurisdiction, we often hear very quickly from Health Canada that this event has been reported, but there may be some negotiations or things happening around the labelling of that particular product. I think that is one piece of information it would be very important for us to get access to in a very timely manner, because that puts us in a bit of a black box, and we're not sure what to do with these reports as they come forward. Are they clinically significant, and should we then be changing our practices around reimbursing some of these products as a result of it?
Again, it would really just be the timeliness of the information and really understanding what that information means. Indicating that there is an adverse event with this product doesn't give us enough context around the seriousness of that event and the frequency of those events happening at that time as well.
Conservative
Director, Drug Program Services Branch, Ontario Ministry of Health and Long-Term Care
Right now we rely on Health Canada, but through some of our listing agreements for some of the products that are on the formulary, if we have concerns around how a product is being used, we may ask the manufacturer directly to conduct some additional observational studies and collect that information for us to help inform our decisions.
Conservative
Conservative
Ron Cannan Conservative Kelowna—Lake Country, BC
Thank you, Madam Chair.
To our witnesses, I'm substituting here today, so I just have a couple of quick comments from observations from your presentation.
With the increased regulation and the regulatory regime that's being proposed, is there a dollar value attached as far as Health Canada is concerned in looking at this five-year window?
Director General, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Department of Health
As you know, budget 2008 provided funding for the food and consumer safety action plan. It was about $113 million over two years. That certainly enables us to begin the work of advancing not only the life cycle approach that's outlined in the proposed legislation but also the associated activities with the overall food and consumer safety action plan the government has put forward.
Conservative
Ron Cannan Conservative Kelowna—Lake Country, BC
That's for two years, though. This window we're looking at is 2007 to 2012. Is that going to mean a supplemental increase down the road?
Director General, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Department of Health
Yes. I mean, we continue to be committed to the principle of identifying and costing activities and forming our resource allocation decisions as we move forward. I can speak to what was provided in budget 2008.
Conservative
Director General, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Department of Health
Those decisions on how it will be allocated are still being made, so I'm not able to speak any further about that at this point.
Conservative
Ron Cannan Conservative Kelowna—Lake Country, BC
Are there implications for the pharmaceutical companies, with the regulatory...? Are there any additional costs?
Director General, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Department of Health
As we move through the proposed bill and other activities, of course there is a requirement to develop regulations. Through developing regulations, we're committed to following the cabinet directive on streamlining regulation, which includes assessing costs and benefits of proposed regulatory approaches and itemizing and presenting those as part of any regulatory packages moving forward.
I'd invite my colleagues to comment further on that if they wish.
Director, Office of Patented Medicines and Liaison, Therapeutic Products Directorate, Department of Health
We anticipate there will be some elevation in the burdens, but you want to target that to the right place.
A lot of the activities are occurring, as Dr. Berthiaume has mentioned. Pharmacovigilance planning is an example. We're receiving those now, because they're making them for Europe and the United States, so it's really putting in this structure that gives oversight to those activities. To the extent that many of the activities are occurring, we want to make sure we're getting the proper structure, and that will also affect the assessment of burden.
Conservative
Ron Cannan Conservative Kelowna—Lake Country, BC
I know that's very important to the constituency I represent. Kelowna--Lake Country in the Okanagan in B.C. has the highest-census metropolitan area of seniors 65 and older. As we're all getting to that age more quickly than some of us would like, obviously additional regulations or additional costs are a concern, so I want to make sure we get the biggest bang for our dollar, as I know each of you does.
I'll follow up on the questions of my colleagues Mr. Brown and Ms. Davidson on the issue of clinical versus non-clinical or off-label drugs, specifically with treatments for cancer, AIDS, and other newer complex diseases. You often have these drug cocktails, as they're known, but there's nothing specific within market authorization. Are you saying you can't compare clinical with non-clinical in terms of adverse reaction?
Director, Office of Patented Medicines and Liaison, Therapeutic Products Directorate, Department of Health
It might help to reset that a little bit.
When we do a market authorization, we're taking a look at studies in particular types of patients, who will be selected depending on what you want to prove with the drug. If it's for a cancer indication of a certain sort, you'll state that, and then you'll do your study on it, and that'll be the basis of the approval. It may be that the same therapy is effective for other types of cancer or other disease states, but we don't know that, because we haven't seen a study in that kind of population, and that's really what off-label means: it means we just don't have that pre-market authorization.
In a situation of practice, it may be that a therapy is extended beyond what's known and studied, based on other things such as medical literature and so on. This kind of practice is often very well founded, but what we get back is not from a population, so if the drug is being used consistently in this way, we're not getting back that kind of information the way we should be, and that's what we're trying to target.
Is that helpful to you?
Conservative
Ron Cannan Conservative Kelowna—Lake Country, BC
Yes.
From a personal perspective, I lost both my parents to AIDS--my mom in 1989, and my dad in 1993. From 1989 to 1993 he was on a cocktail and had to sign off and authorize his physician and Health Canada.
So for 15 years that study on specific sample size has been done. I'm looking at subgroups and at whether you've been able to compare those kinds of effects.
Director, Office of Patented Medicines and Liaison, Therapeutic Products Directorate, Department of Health
What the term “off-label” can mean there is that, again, when you studied it, you may not have combined those particular drugs. “Cocktail” means you're putting several drugs together in a treatment course; you may not have done a pre-market study or a clinical study on that, but they may be used in conjunction with each other, and that would be called off-label as well.
