Health Committee on March 13th, 2008

[The Chair, Conservative, Joy Smith]

Order, please.

I would like to welcome the witnesses who are here today.

What we're going to do is listen to the witnesses, but before we actually hear from the witnesses, I want to remind members that we will be discussing committee business in camera, beginning at 12:30. We will go in camera at that time for discussions.

The witnesses have heard this as well. At 12:30 we will ask you to leave the room so we can go into our business.

We really want to welcome you. We feel very privileged to have you in front of the committee today, and pursuant to Standing Order 108, I'd like to welcome you to the eighth meeting on post-market surveillance of pharmaceutical products.

You know, members, that our panel today consists of representatives from the Anemia Institute for Research and Education, the Consumers' Association of Canada, and PharmaWatch.

Just to get started, I would like to remind the witnesses that witnesses have 10 minutes per organization to make their presentation. What will happen is that the committee will hear all presentations first before proceeding to the members.

Let us begin with Ms. Durhane Wong-Rieger.

[Dr. Durhane Wong-Rieger, President and Chief Executive Officer, Anemia Institute for Research and Education]

Thank you very much. I really appreciate the opportunity to be here.

I am here as the president of the Anemia Institute for Research and Education. I will also speak, though, in my role as president of the Canadian Organization for Rare Disorders.

Let me just put into the context, in terms of post-market surveillance, that for us this really means all the collection, analysis, and utilization of data on the impact of health technology. Certainly we're very pleased to see the health committee moving forward on this. At the moment, I think our major concern is that we believe the way it's being done currently is really not very useful to patient decision-making, and in fact, in some respects it may actually be quite harmful. As patients, we're well aware of the need to balance safety and efficacy, the risks and benefits, costs and affordability, but at the end of the day, patients really have one bottom line, and that is to be able to have access to medicines, and certainly to the most appropriate medicines, as soon as possible.

The second need for us is really making sure that, at the end of the day, the therapies we're getting are perceived to be working. Currently I would say that most of the system around post-market surveillance is really not very helpful to what we would call patients being able to make the trade-offs between risk and benefits, partly because in many respects we just aren't given that information. We're not given it usually from the physician, who may prescribe a medicine and not necessarily talk about it in terms of risk and benefits, and certainly we're not given it from the point of view of the government or from the manufacturers in truly understanding what the trade-offs are in those decisions around trade-offs.

We expect that post-market surveillance, though, is not only going to answer the question, is this drug safe and does it continue to be perceived as safe, but also, is the drug effective? So what we're directing back is to say, in terms of post-market surveillance, that the information, the collection of data, needs to be as much geared towards assuring that drugs are effective, and certainly effective for the specific patient populations for which they're being used, as well as whether they are continuing to be safe. That, to me, is one of the first challenges.

Let me briefly give a couple of scenarios that help drive our thinking.

Certainly the Anemia Institute has been very much concerned, in moving out of an area that the institute grew out of, about the issues around tainted blood. I think what we were keenly aware of, of course, is that at that time, even when the post-market data were very clear that we had a problem with the blood system, there was no uptake in terms of that information. There was no decision-making that actually took advantage of that information as it came down.

I was very pleased, as we went through the reforms of that system, to be named to the first board of directors of the Canadian Blood Services. However, I walked off that board two years later, in part because it was my sense that in setting up the new board of directors and the new Canadian Blood Services, we had certainly abandoned science and logic as a reaction to what had happened and, in fact, became hypersensitive to the issues around the post-market “safety”, to a point where it became very detrimental.

I'll give you two examples. One was the whole issue around banning donors who had accumulated more than six months of stay in England. At that time, the reason for the ban was because of the concerns around BSE among cattle. There was a concern that people who had been in England over a period of time might in fact actually have been exposed to contaminated beef and may be at risk for CJD, and there was a theoretical risk that CJD could be transmitted through blood.

At the end of the day, we made a fairly draconian decision to ban donors who accumulated more than six months of stay. I won't go through all the details of what was wrong with that decision, but I will say that decision was made fully in the face of no science, and actually a lack of common sense. Even today, some 15 years later, when it is very clear that there is in fact no such risk and there has been maybe one potential case of transmission of CJD, and we have in our own country now evidence of BSE in the cattle and we have evidence of it in the U.S., we continue to keep this ban. That, for me, makes no sense.

So we're doing something as a post-market reaction to an incident that happened, but we're unable to actually correct that once we're into it.

The second one I will give is continuing to ban donors who are men who have sex with men. Sure, in the early 1980s that was a problem, but now, some 25 years later, we are overreacting. It's not only a case of shutting the barn door after the horses have left; we're actually not even opening them up again when the horses are desperately needed. We have to be able to set up a system that works on the basis of science and logic and doesn't just become reactionary.

My other concern, as I say, from Anemia Institute, is that one of the recommendations coming out of the blood system was to be able to use alternatives to blood whenever possible, and we've had a real problem now with the erythropoiesis-stimulating agents. Yes, there are really very important issues that post-market surveillance has actually been able to find, and we give full credit to all of the agencies that have been examining that and understanding some of the risks that have been exposed.

Our problem right now is the way in which the process is being done, and certainly the U.S. FDA is a very poor example, in how they're reacting to it. I think it's a reactionary response to what happened with some issues like Vioxx. It does not help patients, and certainly I don't think it helps clinicians, when you have ongoing rolling reviews, ongoing restrictions that are taking place without full evidence. We think there needs to be a systematic approach towards this, understanding how much new information to gather—at what point do you come up with a decision, at what point do you put that out—and not constantly putting out little red flags and sending out DHCPL letters every time you have a new piece of information. It doesn't help us. We have to do this much more systematically.

We have developed some fairly good systems in terms of pre-market clinical trials and how to assess them. We have to apply that to post-market.

Finally, I'll go back to my issues around rare disorders. I think this is a very important opportunity for us to take advantage of what we see as a very positive happening in Health Canada with the progressive licensing framework—the ability to begin to provide some approval around drugs even as the evidence is continuing to be developed. We think the progressive licensing route is a very progressive way of working, and we have been very pleased to see some of the opportunities.

We're hoping that with this progressive licensing framework, as we bring in drugs—especially for the rare disorders, which continue to pose a great deal of difficulty in meeting the kinds of standards that your normal clinical trials would have—we'll be able to set up a very robust post-market system for these drugs, as they're coming in with much earlier evidence.

Certainly we see patient registries as being a very powerful tool to that. Again, I would argue very strongly that we need to have some systematic rules around how we're going to set up those patient registries. I really urge that those patient registries be internationally based, not just for rare disorders but for all—whatever we're doing in post-market surveillance has to be international—and that we also need to fully engage the patients. I think this is where the system has failed the patients. We still do not have a system in which patients are fully aware of where they can report adverse events. They don't get any feedback even if they do report them, and they certainly are not part of the whole post-system of communication and dissemination. Patients need to have information at a post-market stage that is patient friendly and fully understandable.

We applaud Health Canada for the patient-friendly monographs that are coming out with the new drug licensing. We think this is a very positive move. We think that the same thing needs to apply in post-market.

I also applaud very much what Health Canada's doing in terms of allowing people to have direct access to adverse reaction reporting as it's coming out. So as a patient, I can sign up. I can get the warnings. I get a very quick synopsis of it. I can decide whether it's useful to me. I urge, too, that this information also be patient friendly, because what we get is sort of just standard; it's not necessarily fully intelligible to a patient.

In conclusion, I will say that we don't easily praise what is happening in government, so when we do, it means a lot to us. We think that Health Canada has done some very significant things over the past few years, including setting up the post-market, engaging patients fully, and developing the progressive licensing framework that sets up an ongoing opportunity to no longer call it just post-market surveillance, but to have ongoing input.

We do think the patient registries could be a very important part of it, and I would really urge that we more fully engage patients in the reporting of adverse events, in terms of receiving that information, having direct lines into the government, and certainly direct access to that feedback and information.

I would also encourage Canada to do something that we think they're very remiss in, and that is to support patients and patient groups to help disseminate that information. We're one of the few countries I know of in the developed world that does not directly support patient organizations, and it makes it daunting for us to do our work. It's no good casting aspersions on the patient groups for taking industry funding when there are no other sources of funding. I really encourage the government to take a look at that.

Thank you very much for the opportunity. We're very pleased to see the Standing Committee on Health take up this issue. We encourage very robust scientific methodologies for linking post-market surveillance to the pre-market data, but we also urge that the information be considered in a very systematic way, certainly considering the patients at the end of it.

Thank you.

[The Chair, Conservative, Joy Smith]

Thank you very much for your presentation.

We'll go now to Mr. Fruitman.

[Mel Fruitman, Vice-President, Consumers' Association of Canada]

Thank you, Madam Chair.

We at the Consumers' Association are very pleased to have this opportunity to appear here today.

By way of background, for over 60 years the Consumers' Association of Canada has represented the interests of ordinary Canadians in their role as consumers of goods and services as provided by both the public and private sectors. We are not a professional medical advocacy association, nor do we represent persons with specific medical interests or illnesses. Our mandate is to inform and educate consumers on marketplace issues, advocate for consumers with government and industry, and work to solve marketplace problems in beneficial ways.

I am one of those 33 million Joes and Janes—to be politically correct—on the sidewalk mentioned by a committee member. And in fact, I am a volunteer. Since I am a layman, I will speak in those terms and not in medical jargon, in which I am not well versed.

Canadian consumers expect that the goods and services of which they avail themselves will be safe. This particularly applies in the medical arena. We at CAC recognize that the term “safe” is an absolute that can rarely, if ever, be guaranteed, and that a more appropriate term would be “to do no harm”. Consumers instinctively recognize this distinction, since they are aware that overdosing on even relatively benign products can have harmful effects and that many medications have potential side effects or contraindications, to use the technical term, I believe, even though they may not be familiar with the specific details.

We are extremely concerned that apparently an increasing number of pharmaceutical products that have been deemed safe, in that they were available for purchase, have subsequently been found to be anything but. Additionally, consumers are confused by the frequent media reports purportedly based on sound information that tell us that pharmaceuticals that had been promoted yesterday as life-saving are now seen as likely to harm or kill us. All of this raises the question: who, if anybody, is minding the store?

It is our understanding that the current system for approving pharmaceuticals is analogous to the way drivers used to be licensed. After a specified test or tests, the privilege to drive, or in this case to sell, is bestowed and is not revoked except for egregious circumstances. There is no attempt to determine if the capability to perform as required or expected still exists. Unfortunately, the analogy breaks down because there is no capability to revoke the right to sell pharmaceuticals.

Health Canada is proposing the introduction of a progressive licensing regime. To continue the driver analogy, this is similar to the graded drivers' licences that have been introduced over the years, whereby a young driver, after passing a test, is allowed to drive under limited circumstances. As time passes and additional tests indicate enhanced performance, the limitations are reduced until they are completely removed. But again, there does not appear to be a mechanism for following up over time or for revoking the privilege to sell.

Instead of a progressive licensing system—and part of the problem, I think, is interpretation of what that system is—we would prefer to see a continuous one. This would be one in which it is clearly recognized that an authorization to sell pharmaceuticals to Canadians is not an absolute, but that Health Canada can revoke that privilege if at any time it has cause to believe that the health and welfare of Canadians would be better served by removing that product. This means that there has to be an ongoing surveillance of the products. This would include the regulatory authority to require new or additional studies if clinical trials or data gathered either domestically or internationally suggest that there are safety risks for Canadian patients.

We do feel there is merit in allowing some products, as alluded to by Durhane, to be used in limited circumstances during the early stages of evaluation, and maybe evolution. These are cases in which the need for a drug is critical and the risks can be well documented by the manufacturer sufficient for the patient and doctor to make an individual risk assessment and decision.

We have noted during the course of these hearings numerous objections to the establishing of a post-authorization or post-market surveillance system, with reasons ranging from the idea that it would impose too great a burden on the reporters to the idea that the mechanism doesn't exist, how would Health Canada cope with and be able to sort through a multitude of reports, and how is it to be funded. There seems to be surprisingly little thought given to going beyond the excuses to how this can actually be made to work. The starting point has to be a positive one.

We think the Canadian Medical Association has got the right approach, which I think is worth repeating:

...to effectively monitor the safety and effectiveness of the country's drug supply, ...a strong post-market surveillance system should include an effective process for gathering drug safety data coupled with a simple, comprehensive, and user-friendly reporting system; a rigorous process for analyzing this data to identify significant threats to drug safety; and a communications system that produces useful information distributed to health care providers and the public in a timely and easily understood manner.

We need to look at the establishment of a simple, cost-effective reporting system for reactions to pharmaceuticals that may be indicative of potential harm. We are not medically qualified to suggest what the cutoff point for reporting should be; however, much of the discussion seems to have been revolving around whether reporting only severe adverse drug reactions should take place. We understand that a working definition of an adverse drug reaction is “a noxious or unintended response to a drug occurring at doses normally used or tested for the diagnosis, treatment, or prevention of a disease or modification of an organic function”. In some cases we understand that this is qualified by some practitioners who add “significant morbidity or injury to patient, but did not directly cause death”.

We feel that in the interest of patient safety, the lower threshold should apply. We would even express some concerns about the limitation of doses normally used. There will be instances in which patients frequently exceed the specified dose either because they feel that an increase will help them get better faster and/or they were not made sufficiently aware of the dangers of doing so.

The system has to be able to track patterns of behaviour as well as low levels of unintended responses, which may be indicators of a widespread or imminent problem. In some cases, solutions may be as simple as including more, better, or more understandable information with the drug. Of course, if there are indications of a pending serious problem, appropriate stronger action would have to be taken.

We also note that there have been many comments about international harmonization of testing requirements and suggestions that Canada should not proceed on its own but should work only within that environment. It is our fear that this approach would most likely result in extreme delays in moving forward. The work of international bodies' attempts to achieve common ground or consensus usually moves at a glacial pace and with a great deal of politics involved—usually.

One last comment that doesn't appear to directly relate to the topic at hand is that we are adamantly opposed to consumer advertising of pharmaceuticals. In fact, in the context of this current discussion, we think that such advertising has an extremely detrimental effect on the efficacy of the medical system. It can lead to increases in misuse and inappropriate use, leading to overloading any reporting system that may be devised and diverting attention from more substantial concerns.

Thank you very much. I'd be pleased to try to answer any questions you might have for me.

[The Chair, Conservative, Joy Smith]

Thank you very much, Mr. Fruitman.

We'll now go to Ms. Fuller.

[Colleen Fuller, President, PharmaWatch]

Thank you.

I'm representing PharmaWatch. My name is Colleen Fuller, and my colleague Carol Kushner and I are both going to present.

First of all, thank you very much for inviting PharmaWatch. We're really pleased that the standing committee is looking at post-market surveillance. Of course, we have been following the work of the committee for many years and we are looking forward to your report.

PharmaWatch is a consumer advocacy group. We were founded in 2001, like a lot of other consumer groups, to begin pushing Health Canada to do a stepped-up ADR monitoring. We are focused on adverse drug reaction collection, although we obviously recognize that post-market surveillance has a much broader lens than that. We would take the position that the rest of the responsibility within the marketed health products directorate isn't going to get done if there is no data collection. So we do focus on adverse drug reaction reporting, and we are specifically focused on consumer reporting of adverse drug reactions.

Consumer reporting is a relatively recent development both in Canada and internationally. In Canada it wasn't really until the year 2000 that there was a focus on consumer reporting. Consumers began to be identified as a category or a source of report in 1998. That was the first time there was any ability to know how many reports were actually coming from that source. In 1998 it was estimated that 7.1% of reports were contributed directly by consumers, and by 2006 that had increased to 24.2%. So there has been a significant increase in the number of reports coming directly from consumers.

However, the contribution of consumers to the overall collection of data is very, very low, and what we are mostly focused on is increasing the contribution of consumers to the database. One of the reasons is that both our information and an increasing number of international papers that have been published in the last five years indicate that consumers are really able to make a significant contribution to our knowledge about the safety of medicines that are being prescribed. They are often overlooked as a source of information, or the information they contribute is often downplayed because they're not health professionals and physicians and so forth, but they actually are able to make a significant contribution.

Although the level of consumer reporting has increased in the last four to six years, overall, as I said, the number of consumer reports is quite low. We have conducted in the last three to four years a number of focus groups across the country. What we know is that awareness about Health Canada's ADR program is very, very low in Canada amongst consumers. In fact, if you say the term “adverse drug reaction” to most consumers in Canada, they won't know what you're talking about.

We think this situation really needs to be addressed with dedicated resources and funding by the marketed health products directorate. I concur with Durhane that patient groups, consumer groups, really have to be utilized by Health Canada in a much more significant way than they have done so far. We also believe that the priorities within the health products and food branch are focused on approval of drugs and expedited approvals within 300 days and so on, and that this focus needs to be shifted, obviously not entirely, but there has to be a reorientation and a greater allocation of resources and staffing to the marketed health products directorate.

In the summary I have provided a table comparing the resources and staffing that are allocated between the two directorates, the therapeutic products directorate and the marketed health products directorate. In terms of funding, TPD gets triple the funding that the marketed health products directorate gets and almost four times the staff.

We feel there needs to be a rethinking within the health products and food branch about where their resources and funding are being dedicated.

Finally, in our report I've listed our recommendations. I'm just going to finish by highlighting a few of them.

We make two types of recommendations. One is to increase consumer awareness about ADR reporting, and the other is about the actual collection of consumer ADR reports.

On the awareness side, we think there has to be dedicated funding for community-based promotion of consumer reporting and that there has to be a lot more investment in educational materials and promotion through television, radio, and through the media. We think the toll-free number that consumers can use to report ADRs should be listed on every package insert and every prescription label; that there needs to be a source of government-approved, unbiased information about drug safety and adverse side effects; that there has to be material published and geared towards different literacy skills, because this is a major problem in trying to communicate not only information about the reporting system, but about the risks that are detected in the collection of the ADRs. We also need to think about establishing a national clearing house for patient and consumer information on drug safety that is independent of the pharmaceutical industry.

On the collection side, it's obvious that people need to be trained. When we were first set up, we collected adverse drug reaction reports, and believe me, this is not an easy task for anybody. You have to be trained; you have to be educated.

[The Chair, Conservative, Joy Smith]

Ms. Fuller, I just want to say that we have reached seven minutes.

[Colleen Fuller]

Okay. I'll finish by saying that the marketed health products directorate needs a greater investment in direct consumer reporting.

Thank you.

[The Chair, Conservative, Joy Smith]

Thank you.

Ms. Kushner.

[Carol Kushner, Director, PharmaWatch]

Thank you.

I'm here to support a proposal that has been made to the federal, provincial, and territorial ministers of health. It comes out of a need to make clear how to improve post-market surveillance. There are recent news stories about Vioxx, hormone replacement therapy, and SSRIs--the selective serotonin re-uptake inhibitors--which don't seem to work better than a placebo. There are news reports that lowering cholesterol may not be all that it's cracked up to be for large numbers of patients taking certain medications. Apparently it's not helpful to the elderly, and it has never been demonstrated to be helpful to women. Yet large numbers of people in these groups are taking these products and exposing themselves to serious risk.

Canadians desperately need unbiased information about how well drug products work in the real world—information from outside the clinical testing environment. We need to know if they live up to their early promise. We're getting indications that some of these products are not living up to their early promise, that they're not safe when taken as directed. We need clarity about the risk-to-benefit profile of each product as it's approved. We just don't know at this point, and what we don't know can hurt us.

This proposal that I'm urging you to support—PharmaWatch supports it and has been involved in its development—is to create a five-year program of post-market surveillance that could, if approved by these federal, provincial and territorial ministers, fill some important knowledge gaps.

It's being supported by a broad-based coalition of researchers, medical providers, consumer groups, and other health providers. It would be a pan-Canadian project. It would build on existing structures, so there would be no need to invest heavily in new infrastructure. You could use bodies like ICES, the Institute for Clinical and Evaluative Sciences, in Ontario, which already has built-in expertise in this arena. Of course, we need approval from the ministers of health in all the provinces and the federal government.

I see Carolyn Bennett smiling, because she knows how easy that is to achieve, right?

All I'm suggesting is that endorsement of this proposal from this group would be helpful in opening that door.

There are specific advantages to be had from this proposal.

First, there would be a broad-based committee made up of consumers, professional pharmacists, regulatory agencies, research centres, industry, and government, all working together to set the strategic direction and to identify the first drugs that would be part of the investigation.

Another advantage is that it could produce much more timely results. We waited four years to find out about Vioxx, 15 to 20 years to find out about HRT. We're waiting too long to find out what we don't know and what we need to know.

The results could also help provincial drug plans figure out which products they should include in their formularies. We need to know that we're getting our money's worth when we put out those government dollars.

The program would also provide a concrete demonstration of the usefulness of the national pharmaceuticals strategy. It has been around for four or five years, and I don't know that it's produced much.

[The Chair, Conservative, Joy Smith]

I know that we're anxious to answer questions, and you're a bit over time. Would you wrap up, please.

[Carol Kushner]

I have one sentence left. My last sentence is that the proposed budget for this project, which I think is around $20 million a year, $21 million for the first year, is a tiny fraction of the $26 billion we now spend on drugs.

Thank you.

[The Chair, Conservative, Joy Smith]

Thank you.

We'll now go to questions. Dr. Bennett.

[Carolyn Bennett, Liberal, St. Paul's, ON]

Thank you all very much. It's great to see you continuing your role as knowledgeable citizens who are paying attention.

A lot of people are thinking that it's pretty hard to do all this in the bureaucracy of Health Canada. There have been calls numerous times for a separate FDA North or a drug agency that would be a little bit more fleet of foot, with professional leadership, but that might be in a better position to deal with counterparts provincially and would be able to deal with data collection and being on the ground and receiving things.

In terms of a real public health network for Canada, do you have any feelings about the proposal for a drug agency—it would probably be half the staff of Health Canada—off on its own, in terms what we were able to do with the Public Health Agency, with David Butler-Jones dealing with his counterparts?

[Dr. Durhane Wong-Rieger]

If you had asked me this five years ago, I would have said definitely. Many of us have been very pleased with the kind of progress Health Canada has been able to make. Certainly they've demonstrated it, as we look at something like the progressive licensing framework, as we look at some of the post-market surveillance. I sit on the vigilance of health products committee. Health Canada has demonstrated in lots of ways in which it can be fleet of foot.

I will raise one caution about these stand-alone agencies—and this is not to reject the idea, because I think there's some merit in it as well. I go back to groups like CADTH, which are supposedly independent but at the end of the day are accountable to nobody. They're not accountable to the public, but they sit off...and that's not the same as the Public Health Agency of Canada. I have some real concerns about that. They have an independence that was in theory supposed to be good but at the end of the day also becomes counterproductive.

I don't think there's any such thing as being unbiased. Whether it's government, industry, or patients, we all have our biases. To presume there's any way to set up something that is going to be more unbiased because it's outside any particular group....

I think what Colleen and the others have suggested makes great sense. We need multi-stakeholders. We can talk about how we can achieve that, whether it's with an independent agency or whether it's within Health Canada. I would say that probably doesn't matter as much as how it's working.

[Carolyn Bennett, Liberal, St. Paul's, ON]

I would see an agency that would be accountable to the minister, that would give transparent advice to the minister such that citizens would know what the agency said. If the minister, politically, couldn't do it, then the minister would have to account for that.

[Mel Fruitman]

Dr. Bennett, I can't answer that question directly. But I would take it back several steps and say I think it would be very appropriate at this time for the federal government to take a look at consumer protection in its entirety, which has fallen underneath the floorboards ever since the disbandment of the consumer agency approximately 20 years ago, and start at the top, looking at what needs to be done in terms of consumer protection across all areas. Then it could step it down from there and look at what would be the most efficient delivery system for each area. It may involve splitting off the various elements into the different departments, and into departments that do not have a conflict of interest, such as the Canadian Food Inspection Agency.

[Carolyn Bennett, Liberal, St. Paul's, ON]

Thank you.

[Carol Kushner]

At PharmaWatch, we don't have a specific position on creating a separate agency, but we do have a specific position on creating an arm's-length from government research arm through this proposal we've been supporting to collect post-marketing information about specific products.

What's really important is to put the post-marketing and the pre-approval pieces of the current Health Canada regime on more of an equal footing. We've got a terrible imbalance. All the energy is going into getting those approvals. We want more energy going into protecting public safety and looking for those early signals of problems with either efficacy or safety.

[The Chair, Conservative, Joy Smith]

We only have one more minute.

Mr. Temelkovski, you still have a minute to ask a question, if you'd like to.

[Lui Temelkovski, Liberal, Oak Ridges—Markham, ON]

Thank you very much, Madam Chair.

There are numerous agencies that collect data right now. How do you see that data being collected in one place, or do you see it in one place? As far as the funding formula on that goes, should it be funded through the provincial-territorial agencies, or should it be funded directly by the federal government?

[Dr. Durhane Wong-Rieger]

That's a loaded question, as you know.

We believe that it is in fact a national issue, recognizing again that health is funded at both levels. Carol made a comment about FPTs, and we do know how difficult it is for FPTs to work. We know that even the simplest FPT agreement takes many years to work out.

I would turn it back to Health Canada, turn it back to the federal government, to be honest with you. I think we do need, as you've indicated, some kind of coordinated data compository. That doesn't mean that there can't be multiple channels and multiple collections, but there needs to be a coordinated system. Certainly from an analysis point of view, there needs to be one coordinated analysis, so you don't end up with these reports that come out on a rolling basis, where you get a report here and a report there and a report elsewhere. I think it has to come back together to one spot.

So whether it is an FPT or whether it's federal, I think it's pretty much an open question. If you ask me personally, I would say I'd like to see the federal government take the lead on it. And if we're talking about a five-year program, let the federal government step forward and put together a five-year pilot project and fund it. That will make it work. If we wait until everybody agrees that they're going to fund it together, it won't work. It'll take us years to get to that point.

Take the leadership and fund it. Do a pilot.

[Carol Kushner]

I would add that there are already provincially funded agencies. There's a provincial contribution already built into the proposal I was speaking of, in that the Manitoba Centre for Health Policy or ISIS or some other agencies have indicated a willingness and an expertise in this arena to jump in and collect new data on the real world efficacy and safety of drugs. That is a provincial contribution. So it would be always Health Canada working in partnership with the provinces.

[The Chair, Conservative, Joy Smith]

Thank you so much.

Madame Gagnon.

[Christiane Gagnon, Bloc, Québec, QC]

Thank you for being here today.

Ms. Fuller, I would like to come back to your earlier comments. You said that Health Canada is speeding up some of its processes and that the target should be the safety and efficacy of drugs. You were talking about expediting approvals within 300 days. I would like to raise the issue of a drug that has been put on the market, Gardasil. Were the clinical trials really focussed on ensuring the safety of that drug?

When we hear about deaths in Europe and the United States, isn't it risky for the Public Health Agency of Canada to pursue a mass vaccination program for girls from the age of 15? How might Health Canada react towards a product that has been marketed elsewhere but which has caused harm and even deaths?