Thank you very much, Madam Chair.
It's a pleasure to be here today before this committee to provide an overview of Canada's post-market activities for pharmaceuticals. In my opening remarks I will provide an overview of the main components of our program, the measures the department has recently implemented to enhance it, and the new strategies being considered to strengthen our safety system.
As the federal authority responsible for regulating health products and food, Health Canada plays a key role in protecting and improving the health and safety of Canadians.
Let me provide you with an overview of how we are regulating pharmaceutical products, which is the focus of the committee study.
I'll begin with the federal-provincial-territorial roles in pharmaceuticals.
As you know, all levels of government have a clear mutual interest in ensuring the safe and effective use of pharmaceutical products. The federal government is responsible for the regulatory oversight of the safety of pharmaceutical products made available to Canadians, and all governments also provide drug plan benefits to Canadians. In the case of the federal government, it's through the first nations and Inuit health branch for our first nations communities.
Before a pharmaceutical product is authorized for sale in Canada, the manufacturer must provide the department with scientific evidence of its safety, efficacy, and quality. Scientists then review the evidence to determine whether the risks associated with the product are acceptable in light of its potential benefits.
When the product is approved for sale, Health Canada conducts a number of important post-market activities, which this committee has identified in the terms of reference for the study. These include post-market surveillance and compliance and enforcement, as well as risk management activities and risk communication.
Post-market surveillance is the process of tracking pharmaceutical and other health products already approved on the market to access signals and safety trends once these products are in use by a wider population. It is the responsibility of the manufacturer to report serious adverse reactions.
Health Canada also encourages reporting from health care professionals and patients. Health Canada assesses the data and takes appropriate action if a serious health risk is identified or if the risks associated with the product outweigh its benefits. Such actions can range from issuing warnings to the public and the health care community to cancelling the market authorization of a product.
Regulators worldwide face new challenges in the regulation of health products, driven by changing trade patterns, increased globalization of the industry, rapidly evolving science, increased complexity of regulated products, and greater expectations from the public. Steps have been taken over the past several years to address some of the pressures and challenges facing our regulatory system. Through investments in the past, the efficiency and responsiveness of the drug review system has been substantially improved. Health Canada has cleared its submission backlogs and is now meeting internationally benchmarked performance targets for review of new drug submissions for pharmaceutical and biologic products without compromising its high standards of safety.
Following the high-profile safety issues related to COX-2 drugs and building on the recommendations made by the Standing Committee on Health in 2004, targeted measures have been implemented to strengthen the safety of pharmaceuticals and other health products through significantly enhanced funding.
I would like to thank the Standing Committee on Health for its past work on issues related to health products, particularly the 2004 “Opening the Medicine Cabinet” report, which helped guide our most recent work on strengthening and modernizing Canada's safety system for pharmaceuticals.
For your information, we've provided a kit with all the various reports that built on the work of the Standing Committee on Health over the past few years, which has more details about some of the information we're going to talk about this morning.
Improvements made in the past few years to strengthen post-market surveillance, which is of most interest to this committee, include enhanced clinical trial oversight, strengthened assessment and surveillance of marketed products, and strengthened compliance and enforcement.
We have increased our capacity to collect more and better information about the safety of products currently on the market, as well as our capacity to assess the information and to communicate the risk. For example, we have launched the MedEffect Canada website as a single window for timely safety information about health products. There are 17,000 subscribers to the MedEffect e-notice at this point. We are also distributing the Canadian Adverse Reaction Newsletter to approximately 67,000 physicians through the Canadian Medical Association Journal and to 25,000 pharmacists across Canada.
We have also opened two new regional adverse reaction offices, for a total of seven across the country, and have seen a 50% increase in the number of adverse reaction reports submitted to Health Canada since 2006.
While these investments were necessary to address immediate gaps in Canada's current safety system, the view was that Health Canada needed to fundamentally change the way it regulates health products, which is widely shared by stakeholders.
In the fall of 2006, Health Canada launched a broad review of its legislative regulatory and policy frameworks for health products, known as Blueprint for renewal. It articulates a number of orientations to modernize the regulatory system, including proposed strategies to strengthen the safety of pharmaceutical products throughout their life cycle.
We held national consultations with over 150 stakeholders on the blueprint document that you have in your kit. Strong support was expressed during these consultations for the proposed approaches to modernizing our system.
The blueprint outlines a number of gaps in the regulatory system. For example, we have legislation, the current Food and Drugs Act, that is outdated and was designed to address the realities of the 1950s, as opposed to the year 2007. The system is reactive, not always focused on the greatest risks, and uses blunt instruments that often result in a one-size-fits-all approach to regulating products. It focuses on pre-market and point-in-time approaches to assessing the safety of products, rather than looking at risks and benefits continuously across the product life cycle. The experience with COX-2 drugs has demonstrated the need to address these gaps, particularly in post-market authorities and capacity, to help prevent similar incidents from happening in the future.
The proposed food and consumer safety action plan that was announced by the Prime Minister in December 2007 and the related discussion paper that was released and posted on our website in mid-January, a couple of weeks ago, would fundamentally change the regulatory system for regulating pharmaceuticals and other health products so that it can be more responsive to rapid changes in the regulatory environment and better protect the health and safety of Canadians. This shift would be achieved through the implementation of a life cycle approach, an approach that is consistent with other leading regulators, such as the U.S. Food and Drug Administration and the European Medicines Agency.
With the proposed life cycle approach, a number of actions could be taken more proactively to prevent safety incidents, strengthen targeted oversight activities, and respond rapidly to incidents when they do occur, which sets the international standard for vigilance activities.
The successful implementation of the action plan would require legislative amendments to the Food and Drugs Act. Specifically, authority would be required to implement life cycle approaches to regulating health products, thus shifting the focus from pre-market review to one that continuously assesses a product's risks and benefits, both before and after it reaches the market, by putting conditions on the licence. It would provide a more modern and effective compliance and enforcement regime, including modern fines and penalties and the power to remove unsafe health products from the market. It would enable the department, in cooperation with the provinces and territories, to make it mandatory for hospitals to report on serious adverse drug reactions. And it would enhance the openness and transparency of Health Canada's regulatory activities to support greater public involvement in regulatory decision-making.
The implementation of a life cycle approach to regulating health products will provide information about the risk-benefit profile of a drug, based on its use in the real world. It will allow Health Canada to better respond to safety issues when they arise, therefore reducing negative consequences on the health of Canadians related to the use of unsafe products.
This concludes my opening remarks. I have colleagues with me who can provide details on some of the issues we've talked about. I leave it up to you to ask questions, or we can provide the details now, as you like.
Maybe I can give you some information, at least about the effectiveness of the MedEffect website.
We know that since it was implemented in 2005, as a result of therapeutics access strategy resourcing, there were over two million page views and web traffic of approximately 860,000 visits to that website in 2006. So we know from that statistic alone that there is significant interest in that website.
We also note from a survey we did in 2006, a public consultation on the MedEffect website and the online use of it, that there was significant awareness and trust in it, and that Canadians had faith in that vehicle to communicate.
I think part of our problem is that.... I don't want to say no two Canadians are alike, but obviously people have different preferences as to what site they would like to use in terms of the way it's configured. So probably a one-all solution isn't the best. We recognize, for example, that as Ms. Ballantyne said, the Canadian Medical Association and its daily infoPOEMs.... I am a physician and I get those daily, directly in my e-mail box, and I use them. Those are one method of communicating risk information. Other Canadians may prefer the MedEffect website, while others may prefer the Public Health Agency of Canada or other vehicles. We recognize that.
What I can tell you is that we have consulted with Canadians, and the majority of those consulted did have confidence in the MedEffect website as a reliable source of information.
Thank you for being with us today.
We are beginning our information sessions on the post-market surveillance of pharmaceutical products. We made this subject a priority because we read the newspapers and because quite a few citizens are expressing their concerns. There are products on the market that affect the lives and health of the population. Many people are wondering wether they should go on consuming certain pharmaceutical products or using certain cosmetics.
On page 2 of your presentation, Ms. Ballantyne, you say: “Through increased investments, the efficiency and responsiveness of the drug review system has been substantially improved [...]” And then you say that in 2004 “[...] targeted measures have been implemented to strengthen the safety of pharmaceuticals and other health products through funds provided by the 2005 Budget.”
If I remember correctly, the Auditor General had noted that the funding of the regulatory program supervised by Health Canada was on the increase, but that the basic funding, for medication, had decreased by 32% over three years, which means $7.1 million in 2003-2004 and $4.8 million in 2005-2006.
How come you did not mention this gap? You seem to be saying that the budget you have available will enable you to achieve the objectives of your reform. How do you explain that you did not mention anything about a lack of funding and resources? It seems that Health Canada, with the various branches in charge of drug safety, is unable to meet its obligations by supervising the entirety of the process up to the post-market stage of the products.
These are my first questions.
All right. It is because I would like to give you an accurate answer.
We are presently looking at our resource base, further to the AG's report and further to the investments that have been made in the past. We're considering what resources we need to carry out our regulatory responsibilities in an effective and modernized way. That work and those discussions are ongoing at this moment.
There is no question that there is an issue of resources. We're looking at a variety of mechanisms to address that, because it is important for us to make sure we can carry out our work in a way that meets the expectations and needs of Canadians. So we're hoping in the next few weeks to come forward with a response to the public accounts committee. We've done a comprehensive review of our programs and services further to the AG's report. We have some consultations that have been under way on our cost recovery regime, which has also been outdated since the mid-1990s.
What we're suggesting is that there is a need to transform the way we regulate health products in this country, so that we can meet the needs of Canadians now and in the future and keep up with our international partners, because we are lagging behind our international partners. We need to do that in a responsible way and make sure there's sufficient attention focused not just on the pre-market but on the post-market.
In my view, this life cycle approach we're talking about is really transformative in terms of our taking a drug and not just being reactive and looking at it at one point in time, and then just putting it on the market and letting market forces, in this case Canadians, actually experience these adverse effects and bear the consequences of our decisions. So what we're saying is that with the life cycle approach we will be monitoring these drugs and health products throughout their life cycles, so that when these get out into the real world, they are past the clinical trial stage and there are people using them who are very young, very old, with a number of other health conditions, whom we can monitor, and so that we have the regulatory foresight. The latter is not a blunt instrument. Yes, we can always recall a product.... Actually, in this case, we can't, as we don't have the legislative authority to recall a health product in this country, which I personally find absolutely appalling.
So what we're saying at least is that instead of just using that, can we just calibrate what we need to do.
Picking up on the ICH implementation, I think we need to state very categorically and strongly that there is no intention in the modernization to decrease the amount of science that you need to get approved to make sure that there is a favourable benefit and risk for the product when it goes onto the market. That's very important to state. So there is no compromise or shortening on that at all.
The idea is that as you go from the pre-market, which is really an experimenting with the drug, there are still quite a few things you don't know when it gets out into the real population. That's where the science is really starting to grow. It is fairly new. We probably don't have enough pharmacoepidemiologists in the country.
There is a lot of hope, though, that we can work with our decision-making partners in the provinces and so on to really get the best interventions when they make sense. So you really want to keep your surveillance of those risks that are plausible risks that make sense.
And there is a lot of planning element now, so pre-market, a lot of what's in the international environment is making sure that before a drug company is allowed to sell a drug, even in the pre-market situation, they have a really good plan for how they're going to track risks out on the market. And there is a lot more commitment to that planning.
And that starts to appear in regulations. That's not about decreasing the standard for getting on; it's really about governing, and looking, and planning well. Planning doesn't get you everything, so you still need interventions if something is going wrong with a drug, but the idea of planning is fundamentally a good one, we think, and it will improve the oversight.
It may be that you're not, right now, reducing requirements at the pre-market end. I would argue, in fact, that the department and consecutive governments, not just the present but also the past government, have done all the damage they needed to do to change the pre-market surveillance to a risk management model already.
As soon as I was elected in 1997, the first thing that happened was that the Liberal health minister got rid of the one independent drug research bureau that was left to test for--get it--post-market impact. In other words, implications when a drug and a food reacted in a negative way, or a drug to a drug, or a drug and a natural health product--gone.
Scientists have had to leave the department because they stood firm and said, “We aren't going to be bullied by the government, which has been bullied by corporations, to minimize our standards and our scientific data.” So we're now at a point where all those stringent controls at the pre-market level are basically reduced to industry regulating itself.
Now you're going the next step and giving us this fancy language about either progressive licensing or life cycle stuff. I mean, as far as I can tell, these are just nice, fancy words to in fact allow government to take one more step to get rid of the Food and Drugs Act, which is founded on the precautionary principle and “do no harm”, to bring it in line with regulatory, trade, and WTO standards.
The pressures on the international front, in terms of trade, seem to be driving this. Let me give you the example, and you answer. If we have this precautionary model, how was it that we had a situation with rancid baby food on the market, where no one felt compelled to report that to Health Canada, because they were going to wait to see if someone got sick? Then when someone gets sick, they'll report it to you, and you might do something.
Now, that is a perfect example of what the government over the last 10 years has done and what your department is doing now. I would want to know where, in all of this, is the provision to ensure that we have a much more proactive response when dangerous products hit the market.
First, I don't imagine that with food we can do it all, but with drugs, at least, ensure that you have drugs that are safe before they hit the market. You've moved to self-regulation, or “let the industry regulate itself”. Vioxx is a good example. Let it on the market. It's better for the drug companies to go through all the testing and do the regulatory stuff, but let it on the market, and then pay off when someone dies, because it's cheaper for them.
You need to explain to us how this is going to be better for Canadians.
I would add that one of the interesting aspects of the developing science around post-market surveillance is that it is evolving. You asked whether some of this work done before. It wasn't, because the tool to do it was not there.
I have a three-page report, which we could leave with the committee, that talks about what our regulatory partners are able to do in their jurisdictions. We in Canada, as Dr. Bennett mentioned, have an opportunity to lead, using tools like the National Prescription Drug Utilization Information Service, NPDUIS, and COMPUS, the Canadian Optimal Medication Prescribing and Utilization Service. These are resources that we can bring to the table.
With others--for example, in New Zealand, France, and Norway--there are pharmacovigilance centres connected to health care facilities. In the U.K., there's the general practice research database, which resources a group of physicians to keep track of their patients and enables that information to be mined. Data mining, which wasn't as available before, is a tool we use in some partnerships with the U.K. and HRA, our equivalent. We leverage the general practice research database.
But on our side, we also have these opportunities we can bring to the table. We have discussions, as Ms. Ballantyne said, with our foreign regulatory partners so we're able to leverage the worldwide surveillance experience.
The reality is that rare adverse reactions, especially if they are in a subpopulation, are less likely to be identified in Canada than they are when you can data-mine the worldwide experience. If we want to address the needs of a subpopulation, we may have to go to that part of the world to get it. For example, with some of the products, like traditional Chinese medicines and ayurvedic medicines from India, it's much more likely that Canadians are going to be able to mine that information from those parts of the world where there is a larger population.
Those are some examples of our foreign partnerships. We recognize that we don't have to do it all ourselves, but we have to be integrated with our foreign regulatory partners to be able to leverage the expertise.
Thank you for coming today to help us study such a critical area, to ensure that Canadians can be confident that the drugs they are taking are safe.
That's what I would like to ask you. Can Canadians feel a sense of security regarding our current post-market surveillance, particularly in relation to adverse drug reactions?
I know about some fairly recent experiences where there were very serious and potentially serious adverse reactions. I know from the literature we have received that it is not mandatory for health professionals to report. I'm sure many do, but based on what I'm seeing, perhaps many don't. I find it surprising and perhaps somewhat shocking that it is on a voluntary basis. I understand that industry does it on a mandatory basis, but for health professionals it seems to be optional. Perhaps you could illuminate us as to how many physicians in hospitals and in private practice are now routinely providing that information.
On this whole notion of voluntary, you mentioned rare adverse reactions, but how do we know they're rare? Someone could have a serious reaction and may be led to think it is very rare. In fact, if it hasn't been reported adequately, for whatever reason, maybe it isn't so rare. I think this is a critical area in terms of ensuring that confidence.
It sounds as if there is a need to improve. Are we going to make changes that will significantly improve that confidence level, or are we going to leave out this piece regarding information? It's the information that is going to lead us to the best possible decisions for Canadians' health and safety regarding pharmaceuticals.
You're absolutely right that it is mandatory for manufacturers to report adverse events, but not so for health care professionals or, obviously, Canadians.
In the reporting of adverse events, there is a lot of underreporting, for a variety of reasons, going on in terms of barriers to reporting and communications channels. We've been looking at this issue actively, because that's a fundamental part of any kind of post-market surveillance activity. There's no question that, using a multi-pronged approach, we need to try to increase the reporting on these, because that's going to add to our information base in this progressive licensing or life cycle approach.
I'll let my colleagues who've been working on these issues much longer than I have speak to this, but in all our consultations in terms of looking at the international practices, looking across this country and talking to a variety of people, what was felt was that at this point in time there are many folks who are starting to work on putting systems in place to report these incidents. For example, a couple of the provinces—I think Manitoba and Saskatchewan—are putting into their hospitals or regional health authorities critical reporting systems. We have the Canadian Patient Safety Institute, as we know, trying to encourage that, so that it's not an individual who's held responsible and it's a system issue that we can all learn from.
During our consultations with all these folks, what came up was that at this point in time maybe the best place to start could be focusing on mandatory reporting by hospitals of serious drug adverse reactions to their regulated products, because we know that at some stage people will have to be, unfortunately, hospitalized if they've suffered a serious adverse event. What we're saying is that maybe as a first step we will try to have mandatory reporting within health care institutions. We're actively working with our colleagues in the provinces and territories, and there are a number of issues to be worked out, but I think the mood worldwide is to go in that direction, because we know we have to increase the reporting of these things using a variety of means.
We have other approaches. For example, we're working with groups such as the Canadian Medical Association and the Canadian Institute for Health Information in terms of hopefully, in the nearer future, being able to leverage reports without relying on, or waiting for there to be, a voluntary report.
In terms of your point about manufacturers' reports, although 66% of the reports that we get actually come from manufacturers, they get them from health professionals or consumers. So, for example, if there's a 1-800 number on a label and a consumer calls the manufacturer, then the manufacturer has to report it. In other words, the mandatory component is that anything the manufacturer is aware of they have to tell us, no matter where they get it. If they hear about it themselves, or if a physician, a nurse, a dentist, a naturopath or a consumer tells them, they have to make a report.
The problem is that the level of quality may be extensively different, depending on how close they were to the situation. If one were a salesperson in a doctor's office who got a full case report from that physician and then sent it to us, obviously that may be more useful than if we just know that somebody had a rash, but didn't give you a dose, and there's no temporal relationship to when the drug was taken. That's less useful. We would get the full range of that in the approximately 17,000 domestic reports we get per year and 350,000 foreign reports per year. So it becomes a trending exercise.
Then once we've identified what we call a signal, and they're potential signals, then those are further investigated. That may involve actually doing a post-market study. That may involve talking to foreign regulatory bodies. That may involve including academia or provinces and territories looking at utilization information. That may involve purchasing utilization data from groups like IMS, or Brogan Inc., and others who have that kind of information, to be able to put the full picture together.
I think what you're raising is that information can come to us from a variety of sources. For example, today there is a report of a Quebec citizen who had a fatal reaction to taking excessive doses of cold medications.
We don't limit the investigation or the creation of a report to someone actually sending us a report by fax—and we have toll-free fax and phone lines--by the online electronic reporting, etc. If there's a publication in a scientific journal, especially related to a Canadian, and we become aware of it, that can become a case.
So it depends, first of all, on whether it is a regulated product or not. If it's one of our products, for example, if it's a cosmetic, is it a cosmetic that's regulated by another part of Health Canada? It would depend then into which monitoring system it would go, and there are numerous monitoring systems—veterinary drugs, cosmetics, pesticides, etc.
But if it comes into our awareness and it's a regulated drug or product, then we will follow it and examine for trends. So if there is a concern such as was raised, then we would do a search of the database. And some of the fields of that database are public, so if you wanted to search it yourself, you would be able to. That's unique to Canada, actually, that we have that. Then it would be further investigated based on the trend.
Can I just add something to answer your question? We're constantly scanning the media and other reports to see what's out there. As you can well imagine, a number of events and reports come to us.
We have people on the ground. For example, we have seven regional offices in the marketed health products. They're people out there in the provinces and territories working with those communities, trying to get Canadians and health care professionals to report more, encouraging everybody to report more.
The minute we get this data, we're looking at it quickly, making an assessment: is this an issue or not? If it's something that is a really huge issue or something we need to communicate to Canadians, we have a variety of risk communications. We have some criteria to trigger the appropriate risk communications, without, as Mr. Lee said, panicking the population.
Sometimes we will do an information update. If this is one of those cases, we would provide information, put it on our website, put it on our MedEffect website, if needed. Then the second stage would be getting out information to the physicians. We have a health care professionals advisory that goes out through the CMA, through direct mailings, to all doctors in this country. It goes out to pharmacists in this country. We work with the associations.
We use the media as well to get this information out. We recognize that in a crisis situation we would have to get this information out as quickly as possible. For example, there was the counterfeit toothpaste issue last summer. We thought there might have been something in it. Through our inspection programs, we found reports and confiscated this toothpaste based on, I think, a complaint that came up. We analyzed it in our labs. We had to act within a 24-hour period. We erred on the side of having people ask us why we reacted so soon as opposed to why we waited so long.
This branch does a balancing act on a constant basis. We're trying to do this in a much more effective, responsive way. We have to target our resources to the areas of greatest risk. This is what the action plan is talking about, active prevention, because it's in all our best interests to make sure health and safety is protected.
Could I start with the first part of your question, which is, what are the precise instruments we're actually talking about?
What we've been proposing over the last years is an array of tools, and they include, for example, an ability to get companies to do studies, but others to do studies too. In terms of requiring changes on label, making sure that we have nice clear powers...and that's really the information about how to use the drug.
Reassessment. Reassessment is a really important component. In Europe, for example, they require reassessment every five years for every product. It's hard to know, after five years, what you now know about a drug right across the board. So what we're trying to do is study that tool, for example, and figure out how from a data point of view, how from a safety point of view, it is valuable to do a reassessment.
Those are the kinds of tools that we're studying, how they work in other jurisdictions, and then coming back and talking to Canadians—patient groups, academics, and others—about how those tools could work. So once they're hooked into the licensing situation, and you can make them obligations on market and then bring them back into our analysis, that's really where we have this conversation going on. So there are precise tools that you can lay in to do that.
I mentioned pharmacovigilance plans and risk management plans, which are commitments you make—
In terms of your first point, about balancing the benefits and risks of any health product, you're absolutely right that it's a call we make in terms of providing timely access to innovative products but also assuring health and safety first and foremost.
That leads into the CDR. We are currently in the process of reviewing the standing committee's report on CDR. We are taking a very serious look at that, looking at the linkages between your recommendations and this new approach that is being proposed, because there are some linkages. We will be tabling that before the April deadline.
In terms of the CDR, absolutely, the access and timely access to products is what CDR is most concerned with. We look at safety, quality, and efficacy. CDR basically takes that information and puts in another criterion, which is, as you know, the cost-effectiveness. We need to look at that very closely in terms of how we build that into the life cycle approach as we move forward. At this time, I am not able to provide you with a precise answer on that.
Your third point asked what we do once a drug is on the market and is used for another purpose. I'll invite my colleagues to speak to that, but my understanding is that it would have to come back in, because if it's being used for another purpose then that really is off-label use. The company would have to resubmit it through the regulatory process because it is being used for another purpose.
I know that off-label use, particularly in the case of children, where this is.... We know that the clinical trials are often done on adults. Sometimes some of these medications are provided to children without adequate testing being done. That is off-label use, which poses its own challenges. We need to look at that.
I'd like my colleagues to add to that, if they wish.