HEAL Committee Meeting

37th PARLIAMENT, 2nd SESSION

Standing Committee on Health

EVIDENCE

CONTENTS

Wednesday, September 24, 2003

¹

1535

The Chair (Ms. Bonnie Brown (Oakville, Lib.))

Dr. Christopher Turner (Director General, Marketed Health Products Directorate, Health Products and Food Branch, Department of Health)

Mr. Réal Ménard (Hochelaga—Maisonneuve, BQ)

Dr. Christopher Turner

The Chair

Ms. Danièle Dionne (Associate Director General, Health Products and Food Branch Inspectorate, Department of Health)

¹

1540

¹

1545

The Chair

Ms. Danièle Dionne

Dr. Christopher Turner

The Chair

Ms. Danièle Dionne

The Chair

Ms. Danièle Dionne

The Chair

Mr. Réal Ménard

The Chair

Mr. Réal Ménard

The Chair

Mr. Réal Ménard

The Chair

Ms. Danièle Dionne

Dr. Christopher Turner

Ms. Danièle Dionne

Dr. Christopher Turner

The Chair

Ms. Danièle Dionne

Dr. Christopher Turner

¹

1550

The Chair

Dr. Christopher Turner

The Chair

Dr. Christopher Turner

Ms. Danièle Dionne

¹

1555

The Chair

Dr. Christopher Turner

The Chair

Dr. Christopher Turner

Ms. Danièle Dionne

The Chair

Ms. Danièle Dionne

The Chair

Ms. Danièle Dionne

The Chair

Ms. Danièle Dionne

º

1600

Mr. Rob Merrifield (Yellowhead, Canadian Alliance)

The Chair

Mr. Réal Ménard

The Chair

Mr. Rob Merrifield

Dr. Christopher Turner

Mr. Rob Merrifield

Dr. Christopher Turner

Mr. Rob Merrifield

Dr. Christopher Turner

º

1605

Mr. Rob Merrifield

Dr. Christopher Turner

Mr. Rob Merrifield

Dr. Christopher Turner

Mr. Rob Merrifield

Dr. Christopher Turner

Ms. Beth Pieterson (Director General, Drug Strategy and Controlled Substances Programme, Healthy Environments and Consumer Safety Branch, Department of Health)

Mr. Rob Merrifield

Ms. Beth Pieterson

Mr. Rob Merrifield

Ms. Beth Pieterson

Mr. Rob Merrifield

Ms. Beth Pieterson

Mr. Rob Merrifield

Ms. Beth Pieterson

º

1610

Mr. Rob Merrifield

Ms. Beth Pieterson

Mr. Rob Merrifield

The Chair

Mr. Grant Hill (Macleod, Canadian Alliance)

The Chair

Mr. Rob Merrifield

Ms. Beth Pieterson

Mr. Rob Merrifield

Ms. Beth Pieterson

Mr. Rob Merrifield

Ms. Beth Pieterson

The Chair

Mr. Réal Ménard

Ms. Danièle Dionne

º

1615

Mr. Réal Ménard

Dr. Christopher Turner

Mr. Réal Ménard

Mr. Brian Gillespie (Director, Senior Medical Advisor Bureau, Therapeutic Products Directorate, Health Products and Food Branch, Department of Health)

Mr. Réal Ménard

Mr. Brian Gillespie

º

1620

Mr. Réal Ménard

The Chair

Mr. Réal Ménard

The Chair

Mr. Stan Dromisky (Thunder Bay—Atikokan)

Mr. Brian Gillespie

º

1625

Mr. Stan Dromisky

Mr. Brian Gillespie

Mr. Stan Dromisky

The Chair

Ms. Hedy Fry (Vancouver Centre, Lib.)

º

1630

The Chair

Ms. Hedy Fry

The Chair

Mr. Grant Hill

Mr. Brian Gillespie

Mr. Grant Hill

º

1635

Ms. Danièle Dionne

Mr. Grant Hill

Mr. Brian Gillespie

The Chair

Ms. Hélène Scherrer (Louis-Hébert, Lib.)

º

1640

Dr. Christopher Turner

º

1645

Mr. Rob Merrifield

Mr. Brian Gillespie

Mr. Rob Merrifield

Dr. Christopher Turner

Mr. Rob Merrifield

Mr. Brian Gillespie

Mr. Rob Merrifield

Mr. Brian Gillespie

Mr. Rob Merrifield

Mr. Brian Gillespie

Mr. Rob Merrifield

Dr. Christopher Turner

Mr. Rob Merrifield

º

1650

Dr. Christopher Turner

Mr. Rob Merrifield

Dr. Christopher Turner

Mr. Rob Merrifield

The Chair

Mr. Réal Ménard

º

1655

Dr. Christopher Turner

The Chair

Mr. Gilbert Barrette (Témiscamingue, Lib.)

The Chair

Ms. Hedy Fry

Dr. Christopher Turner

Ms. Hedy Fry

Dr. Christopher Turner

Ms. Hedy Fry

The Chair

»

1700

Mr. Grant Hill

Mr. Brian Gillespie

Mr. Grant Hill

Mr. Brian Gillespie

Mr. Grant Hill

Mr. Brian Gillespie

The Chair

Mr. Rob Merrifield

»

1705

The Chair

Mr. Rob Merrifield

The Chair

Ms. Danièle Dionne

The Chair

Ms. Danièle Dionne

The Chair

Ms. Danièle Dionne

The Chair

Ms. Danièle Dionne

The Chair

Ms. Danièle Dionne

The Chair

»

1710

Ms. Danièle Dionne

The Chair

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CANADA

Standing Committee on Health

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NUMBER 046

l

2nd SESSION

l

37th PARLIAMENT

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EVIDENCE

Wednesday, September 24, 2003

[Recorded by Electronic Apparatus]

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[English]

    The Chair (Ms. Bonnie Brown (Oakville, Lib.)): It's a pleasure to call this meeting of the Standing Committee on Health together, and to welcome our witnesses from the Department of Health: Dr. Turner, Ms. Bouchard, Ms. Dionne, Ms. Pieterson, and Dr. Gillespie.

    I'll let you people decide which of you is going to open. We'll hear what you have to say first, and then we'll proceed to questions.

    Dr. Christopher Turner (Director General, Marketed Health Products Directorate, Health Products and Food Branch, Department of Health): Thank you, Madam Chair, for this opportunity to return to the Standing Committee on Health.

    As you will recall, on September 18 officers of the health products and food branch and the healthy environments and consumer safety branch of Health Canada attended the standing committee to address issues related to the committee's study on prescription drugs. The issues discussed at that session included post-market surveillance; drug advertising and direct-to-consumer advertising; and controlled drugs and substances concerning misuse, abuse, and addiction to prescription drugs. That appearance followed the earlier appearance by Dr. Robert Peterson concerning federal regulatory pre-market activities.

    Certain questions were raised, and it was suggested that the first nations and Inuit health branch of Health Canada, which will be appearing tomorrow, would respond. These included drug abuse among first nation citizens, as well as issues concerning provision of health care—which may better be directed to officers of the health policy branch of Health Canada, who appeared yesterday.

    Today Dr. Brian Gillespie, the director of the senior medical advisory bureau in the therapeutic products directorate, will respond to outstanding questions related to issues of transparency, to product-specific questions related to pharmaceuticals, and to the pre-market portion of the product life cycle continuum. In addition, we will be following up on questions raised by the committee on September 18, as well as printed material provided by Mr. Robinson for assessment, in addition to attempting to answer numerous questions submitted to Health Canada.

    Due to the complex nature of the approximately 37 questions received by the department, we propose that written responses may be necessary for certain more detailed questions, which we can flag as we go through the series of questions. We're happy to proceed in whichever way the chair decides we should approach the number of issues raised.

    A number of previous questions asked by the committee members on September 18 relate to activities of the health products and food branch inspectorate. We suggest beginning today with a brief presentation by Ms. Danièle Dionne, the associate director general, on the activities of the health products and food branch inspectorate concerning compliance and enforcement in both pre-market and post-market aspects of the federal regulation of drugs.

    In addition, the officers from the healthy environments and consumer safety branch, Ms. Pieterson and Ms. Bouchard, are again with us today to answer questions that may be related to controlled drugs and substances.

    We are also prepared to brief members in greater detail in committee, or in Health Canada facilities, and/or in technical briefings on this complex topic should the committee feel the need for additional background to the issue.

    I'm not sure if Mr. Ménard visited the therapeutic products directorate today. If you did, or didn't—

    Mr. Réal Ménard (Hochelaga—Maisonneuve, BQ): No.

    Dr. Christopher Turner: You didn't.

    Once he goes, maybe he would be able to provide some insight to you on how that may or may not help the committee. That kind of meeting may help the committee in its deliberations.

    Once again, as your study proceeds, we will be listening carefully to the recommendations of this committee concerning your study on prescription drugs.

    Perhaps the chair could give some direction as to whether it's acceptable to proceed in that way, initiating with a brief presentation by Ms. Dionne, then attempting to go through the essentially five outstanding questions from the previous meeting, and then attempting to go through the approximately 37 questions submitted in writing. I'm not sure if we'll be able to accomplish all of that, because some of them were detailed.

    The Chair: We'll start with the verbal questions and the answers to those, because the submitter of the others is not here.

    Ms. Dionne, would you like to start?

[Translation]

    Ms. Danièle Dionne (Associate Director General, Health Products and Food Branch Inspectorate, Department of Health): Good afternoon. It's a pleasure for me to be here.

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[English]

It's a pleasure for me to be with you this afternoon.

The fundamental objective of the health products and food branch, as you probably know, is to promote good nutrition and informed use of human and veterinary drugs, biologics and related biotechnology products, food, medical devices, and natural health products and also to maximize the safety and efficacy of these products.

    To achieve consistency of approach across the spectrum of regulated products, the health products and food branch created in April 2001 a branch-level inspectorate to deliver a national program using legislation, policy, science, communication and education, and regional operations as a foundation for compliance and enforcement activities. In our fulfilling these responsibilities a risk management approach to decision-making is applied, and senior management's vision of a comprehensive regulatory strategy across all product classes is supported.

[Translation]

    I'd like to switch over to the other language.

    Appropriate standards are applied to regulated products by using an assessment process based on risk management and the best science available to maximize safety, while striking a balance between availability and product quality.

    The Inspectorate conducts inspections of regulated parties, conducts product investigations, issues establishment licences and carries out related laboratory duties, except in the case of regulated food products where the Canadian Food Inspection Agency has responsibility for inspections and compliance and enforcement activities.

    Here are just a few examples of activities carried out by the Inspectorate.

[English]

    More specifically, the health products and food branch inspectorate formulates inspection frameworks; plans and conducts establishment inspections and evaluates them against applicable regulatory requirements, including drug good manufacturing practices and associated regulatory standards such as establishment licensing; conducts inspections in blood as well as semen establishments; plans and conducts inspections of establishments against the medical devices regulations; conducts inspections to assess compliance to good clinical practices regulations; conducts evaluations of foreign regulatory authorities in support of international agreements; and performs inspections of foreign sites where required.

    Furthermore, the inspectorate reviews, assesses, and issues establishment licences and certificates based on inspections for human and veterinary drugs except for controlled drugs, blood and blood components, and other biologics; issues licences and certificates based on attestations for medical devices; and issues export certificates for regulated products.

    The inspectorate also conducts national and regional investigations on human and veterinary drugs, natural health products, medical devices, tissues, organs, xenografts, and products used in reproductive and genetic therapy; conducts investigations related to advertising of marketed products; performs recall monitoring and customs liaison; manages emergency situations involving regulated products; and performs investigations in support of international agreements.

    The guiding principles that govern the inspectorate in the application of the act and regulations are transparency, fairness, a risk management approach, a policy of commitment to quality, and the maintenance of a qualified staff. The inspectorate makes information on compliance and enforcement activities available to the public, consistent with and in the spirit of the Privacy Act and the Access to Information Act. The inspectorate follows a predictable, uniform, and national approach to enforcement for all products regulated by the health products and food branch except for food, irrespective of where or by whom these products are fabricated, processed, packaged or labelled, imported, distributed, tested, or stored.

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    The Chair: What question are you answering?

    Ms. Danièle Dionne: It was a presentation, I think, that was asked for in order to present what activities the health products and food branch inspectorate was active in.

    Dr. Christopher Turner: I think the focus is that several of the questions were related to who takes action. For example, if it's an investigation of an advertising violation, who takes action? I think one of the committee members asked specific questions about the number of inspectors, and we will eventually get to that.

    The Chair: Could we get to it a little sooner than eventually? Let's get to the actual question and the actual answer, if you don't mind.

    Ms. Danièle Dionne: Should I go to approach to compliance and enforcement so it gives you the criteria on which we base decision-making?

    The Chair: No. I thought the question was, how many inspectors do you have, how many violations did you find, and all that sort of thing.

    Ms. Danièle Dionne: If I may, I'll answer this one.

    We have 190 FTEs, full-time equivalent inspectors, throughout Canada. We're located in six different regions or centres from west to east with a national coordination centre in Ottawa. We do inspections, investigations, establishment licensing, and related lab activities. Last fiscal year we did, just as an example, 350 inspections. We do around 200 or 210 investigations on all these products. We did 169 or so recalls in the fiscal year 2002-03, just to give you an example, and the 169 recalls were only on human drugs. Those are some figures that could help you to understand the extent of what we do.

    The Chair: I think that is what the questions were about. I think they were from Mr. Ménard, if I remember correctly.

    With those figures, Réal, do you feel your question has been answered or do you want more general background on this?

[Translation]

    Mr. Réal Ménard: The statistics requested have been provided in writing. That's good. During the question and answer session, I'll be asking specific questions to get a clearer picture of how schedules A and F of the Food and Drugs Act are enforced. As far as the statistics are concerned, we have the full rundown in writing, Madam Chair. My name has been spelled with an h, but that's of no consequence. Perhaps the reason is that I served on the special committee on the non-medical use of drugs.

[English]

    The Chair: I don't see appendix 1. Where's that?

[Translation]

    Mr. Réal Ménard: This is a detailed answer to my question and Ms. Dionne has provided additional statistical information. I see here that the answers have been supplied in both French and English. All of this information can be found on page one.

[English]

    The Chair: The first page; yes, I saw that. So you have more questions on this, other than what you read there?

[Translation]

    Mr. Réal Ménard: Will you go around the table for each question, or are we going to examine each one separately?

[English]

    The Chair: Were there other questions directed to your portion of Health Canada, Ms. Dionne?

    Ms. Danièle Dionne: Yes. The portion I'm responsible for could probably answer the question regarding, I think, DIANE-35 and the new ad campaign. I think that was one of the questions posed this week. We verified with the magazine and all that, and PAAB, which is the Pharmaceutical Advertisement Advisory Board, had given the okay for this ad to go. We've looked at it and it's in compliance with the Food and Drugs Act and regs. I think an ad was referred to, and that ad appeared, I think, in the magazine Healthy Woman.

    Dr. Christopher Turner: This is question number seven for Mr. Robinson.

    Ms. Danièle Dionne: There's a portion there, so we've verified this per se.

    Dr. Christopher Turner: Do the members have the list of the five oral questions and the 37-odd written questions, or do you want us to reread each question to clarify it for the members?

    The Chair: I need to know which question you are referring to.

    Ms. Danièle Dionne: There are a lot of questions.

    Dr. Christopher Turner: It's a little difficult to ask Ms. Dionne to sort of pick through them. What we would prefer to do is go systematically through the questions, and then it may be that Ms. Dionne will answer a part of that question. The original presentation was to give some background to it so people would understand that there were inspectors and what the scope of their activities was.

    Shall we just proceed with the questions?

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    The Chair: In my view, we were getting more than we needed, so you could be just a little more succinct.

    Are we finished with question one now, other than what Mr. Ménard may want to add later? Can we go to question two?

    Dr. Christopher Turner: Question one, in our order, was further to the question that Mr. Robinson posed about the advertisement published in the March 2003 Canadian Cancer Society newsletter. Do you want to deal with that one, or pass--

    The Chair: Yes, let's just go through this in order.

    Dr. Christopher Turner: Okay.

    Essentially we drafted our own questions, because we weren't posed questions specifically on that. So our question was: is it acceptable to Health Canada for the advertisement in the March 2003 issue of the Canadian Cancer Society newsletter to be published?

    The answer is that drug advertising is considered to be any representation by any means--television, radio, magazines, Internet, whatever--for the purpose of promoting directly or indirectly the sale or disposal of any drug. In the case of this advertisement, the ad was referred to the officers in the area who interpret the submitted information in terms of the numerous provisions of the Food and Drugs Act and regulations, as well as interpretive policies that follow from that. The primary policy used here is the distinction between advertising and other activities that have been developed. It contains numerous criteria that guide messages to be considered non-promotional. If a message regarding a drug is not considered to promote sale or disposal, it is not subject to the advertising provisions of the Food and Drugs Act and regulations.

    In this case, this particular ad--and I don't know if the members have seen it--had certain information in it that led it to be considered advertising. The company's name is mentioned as well as that this product is a chemotherapy-related anemia treatment. Since this company has only one product that's a chemotherapy-related anemia treatment, the announcement is considered to be advertising subject to the provisions of the Food and Drugs Act and regulations. It seems to violate section C.01.044, which prohibits any person from promoting a prescription drug to the general public beyond name, price, and quantity.

    So the first question is whether it is advertising. It is considered advertising.

    The second part of this question is: was this advertisement pre-cleared by a delegated pre-clearance agency? Mr. Robinson didn't ask that, but I asked that question because, as we mentioned last time, for advertisements to the general public, there's a voluntary pre-clearance mechanism through Advertising Standards Canada. This advertisement was not pre-cleared, but again, because this is a voluntary system and encouraged by competitors, usually if your competitor doesn't get it pre-cleared, then you're going to make a complaint and get it pre-cleared subsequently. But in this actual situation, because this is considered direct-to-consumer advertising, which is not permitted in Canada, and Advertising Standards Canada does not review direct-to-consumer ads, it was not submitted to them. That's not to say this is correct, but it's the current reality.

    It is important to mention that the various manufacturing associations support pre-clearance by Advertising Standards Canada and the Pharmaceutical Advertising Advisory Board. Health Canada encourages all sponsors to comply with such voluntary review prior to exposure to consumers.

    It wasn't pre-cleared, so what happens next? In other words, when does Health Canada investigate suspected advertising violations?

    Danièle, do you want to respond to that?

    Ms. Danièle Dionne: Yes, sure.

    It's a risk-based approach, of course, and we have a series of criteria that we apply. They are part of the presentation, on the last page, if you want to refer to them.

    We look at risk to health and safety and the compliance history of the regulated party. We look at whether we've had a degree of cooperation from these regulatees, and we look at the priorities and available resources. Of course, in doing that analysis, we then decide if we should investigate or not.

    We cannot investigate everything, so we need to prioritize, depending on the health hazard related to the issue. Usually we go into a fact-gathering mode, then we go to investigation, and of course we investigate all the sides we need to, in partnership with the portion that Chris is responsible for, in order to take appropriate actions based on risk and to enforce the regulations and bring the regulatee into compliance.

    That's how we usually proceed.

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    The Chair: I shouldn't speak for Mr. Robinson, but in the first meeting somebody explained to us the criteria for when a thing is direct-to-consumer advertising. They were, when a condition is named and then when a product or a company that has the answer to that condition is named. Those were the two criteria. We all looked at the ad and we could see both the condition and the name.

    Why would anybody who knows they're advertising and breaking the two criteria, which have to be together, go for pre-clearance? They already know they're not conforming, so obviously the answer to question Q-2, was it pre-cleared, is no.

    Dr. Christopher Turner: But that's not actually true. If they were honestly making a mistake and they approached the pre-clearance agency...these are delegated pre-clearance agencies with codes of conduct that are agreed to by their multi-stakeholder boards. The manufacturer may make a mistake or their advertising company may make a mistake. They may hire an advertiser who doesn't really know or is trying to push the limits or push the boundaries.

    The Chair: Seeing as Mr. Robinson found, and the rest of us discovered at the meeting, that here was a thing that clearly broke the rules, we really want to know what happened. Nobody said it was a criterion that this ad had to be a hazard to health. That's what we're hearing in here. When does it investigate?

    Dr. Christopher Turner: That's why we brought Ms. Dionne in today, because I think some of the questions were along the lines of, so you've defined it as such, but what happens next? Ms. Dionne is presenting what in reality happens next, and it cannot be black and white in the current situation.

    Ms. Danièle Dionne: I guess we apply different sets of criteria at different points in the continuum. We need to decide if it's DTC or not. Once it's done, we apply criteria. When it has been analyzed that it is DTC, let's say, then we will apply another set of criteria in order to prioritize the work and have a risk-based approach as to how we will solve this issue.

    The Chair: Why don't we just prosecute when we see somebody is breaking the law?

    Ms. Danièle Dionne: That's a very good question. Compliance and enforcement are an art. You cannot just prosecute like that. In order to prosecute you need to have evidence to table; it needs to be recommended to the Department of Justice. There's a full process to go through in order to go to prosecution. I guess the key point is that really in terms of drugs on the market or even a DTC kind of issue, the industry, or the regulatee, has a responsibility as well. It's a shared responsibility.

    The Chair: The industry is deregulating. Is that what you said?

    Ms. Danièle Dionne: No. I'm saying that the industry has a responsibility in order to apply legislation and regulations that are public. Health Canada has the responsibility to make sure they meet these regulations, to make sure they're in compliance with the regulations.

    The Chair: And when they're not?

    Ms. Danièle Dionne: When they're not, we have a process based on a risk approach in order to see, and we have all these criteria to build the compliance. Usually the first step we will take is a compliance letter, then we will go to a warning letter, and then we could have formal hearings. It always depends on the level of risk. If it's a very high risk, we'll act within 24 hours.

    What is very important is to mitigate the risk. At the end of the day, prosecution doesn't do that. Mitigation of risk will happen by stopping the sales, by recalling the product, and by communicating this information to the Canadian public. That's the risk mitigation that needs to happen in a very fast mode. Prosecution is part of the role of the regulator in order to make sure the regulatee is responsible for the acts that happen. Prosecution will bring closure to an investigation, but the real risk mitigation doesn't happen with the prosecution; it will happen with faster tools to mitigate the risks.

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    Mr. Rob Merrifield (Yellowhead, Canadian Alliance): I just have a point. We have the questions that were asked verbally and we have the answers here, but the individual who asked them is not here. He'll have the answers in writing. I would suggest we do the same with the other questions that were asked through the clerk.

    I think the people who are in this room are interested in their own questions and their own answers, not in those of a member who is not here. I think we should proceed with the presentations, if they have any more, and then go on to our own questions. They might be somewhat different.

    I'm more interested in getting some answers to questions I have than I am in listening to questions from an individual who is not here.

    The Chair: Well, I don't quite understand this package, because it has questions numbers 1 to 5, then there's a second one of 1 to 5, and then.... I don't understand what these are. They're not laid out.

[Translation]

    Mr. Réal Ménard: I tend to agree with Mr. Merrifield. It's understandable that our colleague Mr. Robinson may have another commitment, but we have to work with those members in attendance.

    Why not give members who are here five or seven minutes to get up to speed on certain questions? At least we'd have a chance to read some of the documents we received. In my opinion, we shouldn't be called upon to answer 15, 20 or 30 questions all at once. That's ridiculous. Instead, I suggest that each member voice his or her concerns. If someone needs more information, he or she can request it in writing.

    Therefore, I suggest we go around the table and give each member an opportunity to identify his or her concerns.

[English]

    The Chair: Is that agreeable? You can look in here, and if there's something in here you're not happy with, you can raise that or you can raise another complaint.

    We'll start with Mr. Merrifield.

    Mr. Rob Merrifield: Thank you for coming back and answering some of our questions.

    First of all, just to give us a sort of snapshot of the adverse reactions we have in Canada, can you tell us how many adverse reactions to drugs were reported in 2002?

    Dr. Christopher Turner: That wasn't a prepared question, so I can tell you the answer off the top of my head.

    I rejoined Health Canada in about 1997. At that point we were receiving--I'm talking domestic adverse reaction reports--approximately 4,000 per year. In 2002 we received approximately 10,000, and that has caused us some issues. We say there's an approximately 15% increase per year in domestic adverse reaction reports. Now, you may think that's a good thing, but it can also sometimes be a bad thing, because without a 15% increase in your resources in that area, it means you have 15% more work to do.

    I'm talking about just the domestic reports. We also receive 100,000 foreign adverse reaction reports, and those are principally the ones submitted by manufacturers as part of the mandatory reporting scheme.

    Mr. Rob Merrifield: When you say “domestic”, that's physicians, consumers--

    Dr. Christopher Turner: “Domestic” would be health professionals and consumers in Canada. The actual number is 106,654 foreign and 8,566 domestic. We're aiming at, I think, 10,000 in this fiscal year, but as I say, both of them are going up about 15% per year.

    Mr. Rob Merrifield: What's your estimate on those that are not reported, if you can use international figures as an example, maybe?

    Dr. Christopher Turner: In international adverse reaction reporting--and this doesn't only apply to adverse reactions to drugs; it also applies to adverse reactions for public health kinds of issues, such as adverse reactions to vaccines--it varies anywhere from 1% to 10% to 13%, depending on the jurisdiction and the rules and regulations in the area.

    Recently I visited the European Medicines Evaluation Agency, and it was an interesting conversation because I was meeting with a variety of representatives from different countries, and it was kind of all over the map. No one is satisfied with it, but then, as I said, in the business of adverse reaction reporting the reports are almost all suspicions. They very rarely ever directly prove anything, and the reason for that is the quality of the reports. In addition to quantity, quality is very important.

    If you can have, obviously, a coroner's report with a post-mortem examination giving you an exact cause of death and relating it to a product, it's extremely useful. If you have, as I said the last time I was here, a patient in ICU with five or six diseases and multi-organ failure who is on 20 different drugs and then they get a rash, well, how do you know it was the disease or the rash? You then base your evaluation on trending, building up case series, and also interacting internationally.

    In Canada, being a relatively small country in terms of population and also sometimes--a bad thing--being a little late getting drugs on the market, we need to, and we do, rely on adverse reaction reports from other countries. As you know, there are some examples where products have been taken off the market in other jurisdictions before they hit the market in Canada because they've been on the market there for a couple of years and they develop a risk-benefit profile that's adverse. Then the submission may be withdrawn in Canada even though it's under review.

º  (1605)  

    Mr. Rob Merrifield: Just specifically, if there was mandatory reporting here, what would you expect the number to be?

    Dr. Christopher Turner: We have no idea--

    Mr. Rob Merrifield: A ballpark guesstimate?

    Dr. Christopher Turner: --but we did do a survey of the countries around the world who use primarily mandatory reporting in legislation. As I mentioned last time, according to the French, who are some of the leaders in this area, it increased neither the quality nor the quantity of reports significantly. Now, that's not to say there isn't value in having legislation that may have that requirement, and at the present time we're evaluating the full risks and benefits of going forward in that way.

    We have just recently completed a survey--I don't have the results yet, because it's just been done--about health professionals and consumers and media. One of the questions in the survey asked about mandatory reporting and about whether they liked it or not. So we will be able to report back later on that.

    Mr. Rob Merrifield: Okay, that's fine. I just don't want all of my time to go to those issues. I want to ask another question.

    You described the actual details of some of the things you are inspecting and actually licensing. We're talking about blood, semen, tissue, regulated products, natural approved products, and so on. You do a significant amount of recall of products, I would imagine, when a product doesn't meet the test, in some cases, of what it claims to be providing. Can you tell me what criteria you have, and are you doing inspections on the licensing of marijuana for medical purposes?

    Dr. Christopher Turner: Probably the healthy environments and consumer safety branch should start on any issue related to marijuana.

    Ms. Beth Pieterson (Director General, Drug Strategy and Controlled Substances Programme, Healthy Environments and Consumer Safety Branch, Department of Health): Your question is related to inspections for medical marijuana...?

    Mr. Rob Merrifield: I'm wondering if licensing of it is really suspect, and what criteria you use to license, and then what kind of inspection and follow-up we are doing on the product as well as the patient.

    Ms. Beth Pieterson: I'll start with the product. Some questions were submitted in writing by Mr. Robinson about the product specifically, but I won't address those now.

    The product itself is inspected. It's grown by a company we've contracted, and we have gone to that facility and inspected--I don't even know how many times, but several times--to see if it meets our requirements. The standards applied to that company for production are the good manufacturing practices applied to other regulated drug products.

    Mr. Rob Merrifield: So let's get into the licensing of it, then. Did you recommend the licensing of it for medical purposes?

    Ms. Beth Pieterson: Yes. This company is licensed by Health Canada to produce that product for us.

    Mr. Rob Merrifield: So does it meet the same standards as other licences? On what basis are you licensing it, on what scientific evidence, on what criteria? Does it meet the same criteria as the other drugs you're licensing?

    Ms. Beth Pieterson: No. Marijuana is not an approved therapeutic substance, so when someone gets an authorization to possess marijuana for medical purposes, that's all it is. There is no evidence at this point to support its use in the smoked form.

    Mr. Rob Merrifield: So what you're saying is that Health Canada right now is providing a product with no medical criteria for using it.

    Ms. Beth Pieterson: The MMAR came into effect in the year 2001. It came into effect because the court ruled it was unconstitutional to not allow people to possess marijuana for medical use. Therefore, they ordered the government--and I'm simplifying somewhat--to develop a system that would allow people to legally possess marijuana and cultivate it, should they choose, for medical use. That's the system that's in effect today.

    Subsequent to those regulations that came into effect in 2001, another court ruling earlier this year found once again that the regulations that allow people to possess or cultivate marijuana for medical use, the MMAR, were once again unconstitutional. That is because if the person couldn't grow it themselves or have someone cultivate for them, they were required to purchase from the black market, essentially. So they were declared unconstitutional because we didn't provide for a licit source. That's why the government is now providing a licit source of marijuana. The regulations do not state, and neither has the department ever stated, that it's an approved therapeutic product.

º  (1610)  

    Mr. Rob Merrifield: So what you're saying is that this is controlled solely by the courts.

    Ms. Beth Pieterson: The access regulations for medical marijuana, that's right.

    Mr. Rob Merrifield: So it would be the same it if were opium.

    The Chair: Grant.

    Mr. Grant Hill (Macleod, Canadian Alliance): I'd be happy to turn my time over to my colleague.

    The Chair: Okay, good. He still has only a minute and a half left, because he's at 8 minutes, 30 seconds.

    You have one minute and a half.

    Mr. Rob Merrifield: I would like to know, then, if a court.... Let's say there was a challenge in court for growing opium from poppy seed. Would the same criteria apply, that it would be controlled by the courts? What is the recommendation of Health Canada when it comes to this whole area of drug approval, which goes completely against anything we've been told in the last two weeks?

    Ms. Beth Pieterson: No, it's a good question. Marijuana is totally unique right now--

    Mr. Rob Merrifield: I know it's a good question; I'm looking for a good answer.

    Ms. Beth Pieterson: Yes, well, I know, I don't have good questions.

    The courts do make some decisions, but I don't think.... You know, marijuana is unique, and there was compelling evidence presented in court that...and there is some scientific evidence, too.

    Mr. Rob Merrifield: All right, fair enough. But in terms of patent law, we already have had this product being prescribed in pill form for years in Canada. So why would the courts not recognize that product in a pill form rather than a smoke form?

    Ms. Beth Pieterson: Again, good question. It's because the applicants in the case gave very compelling evidence that smoking marijuana was more effective to them than the oral dosage form. When you smoke marijuana, it gets absorbed into the system very quickly, and you can control the exact dosage. So that was the evidence they presented, and the courts believed that was strong enough evidence.

    The Chair: Mr. Ménard.

[Translation]

    Mr. Réal Ménard: My questions are directed specifically to Ms. Dionne and to Mr. Turner.

    First off, I've glanced at the documents you submitted. As I understand it, we as a committee need to focus on strengthening provisions in the Food and Drugs Act respecting the prohibition on advertising. It's not so much a question of what was done in the past, but of what action needs to be taken in the future. Consider the example given by Svend Robinson.

    According to the documents submitted, two agencies, which you identify, provide advice on a voluntary basis on informational material. However, they have no mandatory authority to act in this area. Parties submit to the regulations through voluntary notices of compliance.

    It's important to note that contrary to popular belief at the outset of our proceedings, there is no general ban on drug advertising. The prohibition applies to establishing a link between the disease and the drug. Furthermore, a distinction must be drawn between advertising directed to health care professionals and advertising for members of the general public, like us.

    Nevertheless, I don't understand why, once the two agencies agree that a violation has occurred, you seem powerless to ensure legislative compliance. Is it possible to take cases all the way to Federal Court? If the provisions of the Food and Drugs Act have in fact been violated, can you take steps to prosecute violators? Do you have the authority to enforce the law or are your hands completely tied, figuratively speaking, of course?

    Ms. Danièle Dionne: Mr. Ménard, you mentioned strengthening the provisions of the Food and Drugs Act. I believe the department is looking into that, as part of the legislative review process. As to whether we have the authority to prosecute violators, the answer is yes. Pursuant to provisions in the Food and Drugs Act, we can exercise this authority. As I tried explaining earlier, we do prosecute parties that violate advertising regulations.

    On the issue of compliance, it's important at the outset to assess risk. If the risk is significant, action must be taken quickly, and prosecution is not the first step. Ultimately, however, violators will be prosecuted and made to comply with the Food and Drugs Act. However, as a rule, we opt for a quick solution.

    Naturally, we contact the parties that we wish to see comply with the legislation and in some cases, we ask them to pull an advertisement, for example. Their cooperation is important, because that is the first step toward legislative compliance. However, when these parties fail to comply or are uncooperative, a decision is required on follow-up action, depending on the directorate's resources and on other priorities in terms of health risks. The Food and Drugs Act does indeed provide for this possibility.

º  (1615)  

    Mr. Réal Ménard: Is the term “brand name” synonymous, in your mind, with “trade mark”, that is with a trade mark that can be registered?

[English]

    Dr. Christopher Turner: What I was mentioning was that if it's been pre-cleared by Advertising Standards Canada or by the Pharmaceutical Advertising Advisory Board, it will have a little symbol on the ad. This ad did not, so we could tell it was not pre-cleared. That assists us, obviously, and it also gives some credibility to the ad.

    In addition, certain broadcast media and others insist, before they print an ad or run an ad on TV, that it has the pre-clearance. That is, unless they are...I don't want to say “in cahoots” with the advertising agency or whatever to encourage that kind of thing, going close to the margin, pushing the margins of what is legal and not. But the vast majority of reputable organizations, as part of their process of reviewing the information they're going to post in their print media or broadcast media, will look for the little logo.

[Translation]

    Mr. Réal Ménard: Could I ask you a question concerning drug marketing? Is everyone alright with that?

    There is another important issue that we need to understand. Pharmaceutical companies occasionally chew me out, but so too do many other people, and I don't lose any sleep over it. The Patented Medicine Prices Review Board classifies drugs for which a notice of compliance has been issued as Schedule A, B or C drugs. Some consumer groups and other agencies maintain that Health Canada issues notices of compliance for drugs that fundamentally have relatively little new therapeutic merit. The challenge facing our committee is understanding how that's possible, given the link between new drugs and their cost. What are the criteria on which your assessment is based? How is it that some drugs for which notices of compliance are issued do little to improve people's lives? Could you explain that to me?

[English]

    Mr. Brian Gillespie (Director, Senior Medical Advisor Bureau, Therapeutic Products Directorate, Health Products and Food Branch, Department of Health): Health Canada must review all drug submissions submitted to it. The drugs are reviewed for safety, efficacy, quality, and compliance with the regulations. There is no regulatory authority to deny a notice of compliance on the basis of relative therapeutic merit. The relative value of an approved drug, or its therapeutic merit and where it fits in the therapy of a specific patient, is determined by the prescribing physician and in part by third-party payers, where the drug is paid for by an insurance program.

[Translation]

    Mr. Réal Ménard: That's the most important aspect of this question. Thank you for your answer because it sheds considerable light on the subject for committee members. If the committee were ultimately to recommend that Health Canada not issue a notice of compliance if 50 per cent of the therapeutic benefits associated with the drug weren't new benefits, would you be prepared to follow up on this proposal? If the legislation were amended and the legislative and regulatory framework reviewed, from a scientific standpoint, would you be prepared to follow up on a recommendation of this nature?

[English]

    Mr. Brian Gillespie: The evidence that would be presented to Health Canada would have to vary, because there would have to be comparative trials with other therapeutic agents on the market at that time. As well, it may be very difficult to determine a priori if there are significant and important therapeutic benefits.

    I'll give you an example that goes back a long time, although it dates me. There's a type of penicillin known as ampicillin, a broad-spectrum antibiotic used for the treatment of acute otitis media, or ear infections, particularly in small children. This drug had a real problem in that it frequently caused severe diarrhea in those children, who were already sick. Another drug came along, very similar to it, called amoxicillin, that did not have the problem with diarrhea. Therefore, very quickly the clinicians who were treating these children decided it was to their advantage and to their patients' advantage to switch to a drug that had a reduced side effect profile, as in that example.

    Penicillin G, perhaps the earliest penicillin on the market, is another good example. It's poorly absorbed because it's broken down in the stomach by acid. It was replaced by penicillin V, which is resistant to the acid in the stomach, and therefore the physician can be much more assured that when the patient takes the drugs they're going to get adequate blood levels and a good therapeutic effect.

    So we would have to be very careful if we were doing a comparative type of thing, because some of these things may not be identified when we're looking--

º  (1620)  

[Translation]

    Mr. Réal Ménard: Would you be prepared to do that? For example, associations...

[English]

    The Chair: Mr. Ménard, you're at nine minutes.

    Mr. Réal Ménard: Oh, you owe me one minute.

    The Chair: Mr. Dromisky.

    Mr. Stan Dromisky (Thunder Bay—Atikokan): Thank you very much. I'd like to follow through with the kind of question that's going on right now.

    The other day I raised my concern regarding trial runs and data that pharmaceutical companies have put out regarding some of their products. I'm always suspicious, if somebody has a great deal of money invested in some product, that they hope to get into the market and reap a great profit. Have variables changed? Did they drop some of the data out of their record-keeping processes to taint, in other words, what they would like to reveal to the public as acceptable levels of whatever it might be?

    I understand that your department has some responsibility in following through with trials that are out in the field there. Do you check the people who are involved in their trials? Do you check the data that pharmaceutical companies are recording--how accurate they are, and whether there is a certain degree of validity? The whole question of accountability comes to mind.

    Is it true that you people have some responsibility in this area? Do you actually do something?

    Mr. Brian Gillespie: Yes, we do. Initially, we review proposals for clinical trials and look at the protocols and the evidence that is available at that time as to possible issues with a drug. We ensure that the patients receive that information, that they sign an informed consent, and that the investigators have full details of everything that is known about that drug before they can enrol patients in the trial. We then issue a no-objection letter.

    The manufacturers or sponsors of those clinical trials are obliged to adhere to good clinical practice. The inspectorate arm inspects a certain proportion of those trials to ensure that they are adhering to good clinical practice. Subsequent to the development of the evidence or data in those clinical trials, if the manufacturer wishes to market the drug in Canada they must make a complete submission to Health Canada of all of the data that is known about that drug, both positive and negative. We review that data, as I mentioned previously, looking at its safety, efficacy, quality, and adherence. If it meets our very high standards, which are recognized internationally as being very high, then the drug is issued a notice of compliance.

    The pertinent information for using that drug safely and effectively goes into what is known as a product monograph. This is a document that is prepared by the manufacturer but is very closely reviewed by Health Canada, and provides factual, non-promotional material to prescribers for the safe and effective use of that drug. A portion of the product monograph may also include information for the consumer. That's where important details about the safe and effective use of that drug are contained that the physician or pharmacist can give to their patients.

º  (1625)  

    Mr. Stan Dromisky: In your history of being involved with the institution, have you come across a case where a Canadian manufacturer has sort of ignored some of the regulations and had to be chastised for it?

    Mr. Brian Gillespie: We have certainly stopped clinical trials because of concerns, although I can't go into the details. In terms of evidence that a manufacturer has submitted falsified information or withheld information in a new drug submission, I have no experience with that or evidence of that.

    Mr. Stan Dromisky: Thank you very much.

    The Chair: Ms. Fry.

    Ms. Hedy Fry (Vancouver Centre, Lib.): Thank you, Madam Chair.

    I want to go back to the whole issue of adverse reporting. I know it's not a silver bullet or a panacea. I know you have suggested that the amount of adverse reporting has increased by 15% per year, and some of it is very ambiguous.

    However, most family physicians and people who are in clinical practice and give prescriptions all the time tend to know their patients, and tend to report things about their patients that they think are different with a particular drug or device. It may not be something that meets the “coroner's criteria”, but it may flag for them something that's wrong. If they see enough of it in a practice, they may think it's worth reporting. I think this is very important if we're to deal with safety. We're not talking about efficacy here; we're talking about safety. How would we have known about penicillin G and ampicillin if people hadn't reported things like that?

    I think there needs to be a way of simplifying it. As a physician--and I'm sure Dr. Hill will agree with me--none of us want a bunch of forms to fill out and things to do. We get enough of that. But there should be a very simple checklist that a physician could just tick off and send in to Health Canada or your department. You could just tick off “suspected” or “proven”.

    If you got 2,000 suspected adverse effects, that would be significant. A lot of people may not think diarrhea is significant, but diarrhea is significant in a small child, as we know. It could lead to dehydration and all kinds of things. Also, adverse reporting of nausea, heartburn, and stuff like that might actually decrease compliance, in terms of efficacy.

    I think it's an important thing to do. I think we have heard enough in the past, as a health committee, that makes us wonder if somebody is watching the farm. You don't know what's going on unless you get a report from somebody. I know you don't want to be inundated, but if at the end of the day your mandate is safety, then you may want to know what's going on out there. The only way you can know is to do it.

    I know you're under-resourced, etc. That may be something we have to talk about and deal with. Let's take that on. We shouldn't use it as a reason for not dealing with the issue. If you had something that was very user-friendly and you could just tick “suspect” or “proven”, you could collect that and go through it. If enough people across the country suspected something strange, that might flag it for you.

    Those are some of the things that concern me as a physician. We depend on getting from you some kind of letter that says, “It hasn't been proven that this drug has an adverse effect, but we've been getting a lot reports from people across the country saying they've seen this. They're wondering if they can add two and two and get four out of it”. That might help us look for it, as physicians. We might be overlooking it, but it might help us to help you to do some of that work, as well.

    I think that's an important piece. A lot of people believe that Health Canada, rightly or wrongly, hasn't been minding the farm, and they don't feel they can trust Health Canada in order to feel safe in what they do. I think it's very important for the system to start to amend itself, to make people feel a sense of trust in it. Whatever we need to recommend, such as better resourcing for you, at the end of the day safety has to be met. Canadians have to feel safe in the food they eat and the drugs they take. I think that's important.

    Madam Chair, if I have a bit of time I want to talk quickly about advertising.

º  (1630)  

    The Chair: You have about 45 seconds.

    Ms. Hedy Fry: Advertising is something that I think impacts on usage and cost. I have seen advertising on TV--it may be American--and I think Viagra is a good example. All kinds of people now have “erectile dysfunction”. What is that advertising doing to the cost of drugs, usage, and inappropriate usage? How do you assess that kind of advertising and the pressure that's put on family physicians or other physicians to give medication that is being advertised?

    I think advertising is key to use costs and to misuse. I don't know how you're dealing with that. I've seen advertising that I don't think should have been there.

    The Chair: That's five minutes.

    Dr. Hill, and then Madame Scherrer.

    Mr. Grant Hill: To switch gears a little bit, you spoke about your criteria for looking at advertising and products according to risk. You have a responsibility for natural health products, and it still puzzles me what risk you have found with a product such as melatonin, which I'll use as a specific example. As a natural hormone produced by our bodies, melatonin is used for sleep disorder and jet lag, but Health Canada has said that melatonin cannot be available in health food stores in Canada. So can you give me some sense of where the risk with melatonin lies, and what scientific information caused you to remove that product from the shelves in Canada?

    Mr. Brian Gillespie: The product was removed from the shelves because it was not an authorized drug. We had received no information from any manufacture substantiating the safety, efficacy, or quality of the products being sold in Canada. The Food and Drugs Act and regulations require that drugs have to be established in terms of safety and efficacy and quality and not be misleading or have fraudulent claims associated with them. At the time, there was very, very little information available on the use of melatonin. There was some very preliminary information on jet lag, and even then it was not clear, and its effectiveness appeared to depend on which way you were flying, whether from west to east or east to west.

    I haven't followed melatonin closely recently, but I do know that within the last month or so, there have been a couple of reports out on adverse effects associated with melatonin in the United States. Unfortunately, my memory fails me as to what exactly they were, but it was in my general reading that I came across on them, and I could try to locate them.

    The initial reason that melatonin was not permitted on the Canadian market was that we had no information on its safety, effectiveness or efficacy, and quality. It's a hormone, and as you're well aware, hormones have a lot of effects, some of them not so apparent initially. A good example in the past was that when corticosteroids came onto the market, they were miracle drugs; they had wonderful effects in terms of what they would do for patients, say, with chronic arthritis. But with experience, it was learned that they were a double-edged sword. In many cases, they could cause very serious adverse events if they were used in certain populations or for a prolonged time.

    So applying the regulations that require substantial evidence of safety, efficacy, and quality before we permit a drug on the market, melatonin was treated like any other drug coming onto the market.

    Mr. Grant Hill: The interesting corollary to that is that melatonin was allowed under personal importation rules. You can see how inconsistent that seemed to an individual taking melatonin, which was suddenly removed from the market simply because, as you have said, you did not have enough information to make an informed judgment. You have said there were no significant risk factors identified, yet the product can come in under personal importation rules. I find that inconsistent. Can you explain that?

º  (1635)  

    Ms. Danièle Dionne: We have in Health Canada what we call a personal importation directive, which gives Canadians the possibility and opportunity of bringing back with them a 90-day supply for their own use. So they cannot resell it, but it's for their own use. I guess each country in the world has the same kind of approach. So when you're travelling, you can of course bring medication for yourself to the other country, and you can bring back the medication as well.

    David is flagging to me that it's in the regs and is subject to one very particular portion: “no person shall import into Canada for sale a food or drug the sale of which in Canada would constitute a violation of the Act or these Regulations”. So that's how it's carved in the Food and Drugs Act and regulations.

    Mr. Grant Hill: You can see how inconsistent that is, though. You have taken the product off the Canadian market and yet the public can bring it in for their personal use. If I have a health food store that has sold this product, and my customer now has to go to Seattle to bring it here, you can see how it doesn't make any sense to that individual.

    I'm flagging this because, while I think your risk assessment is very fair with pharmaceutical products, I consider it to be arbitrary when it comes to natural health products, or things that are not traditionally considered to be pharmaceutical products. I continue to say that I think this arbitrary way of handling those products harms your reputation as a good regulator, and I think it harms Canada's reputation as well.

    Mr. Brian Gillespie: I have to point out that although many individuals consider natural health products to be innocuous and harmless, in the past few years Health Canada and regulators around the world have acted to removed natural health products, which may have been in use for considerable lengths of time in their traditional form or medicine, because of very serious adverse events.

    A good one is aristolochia, a Chinese herbal product, which resulted in severe renal failure in approximately 100 women who were taking it for weight loss in the early 1990s in Belgium and France. These women actually ended up with renal transplants and going on dialysis. When their kidneys and ureters were explanted for their kidney transplants, it was found that many of them had early cancers of the kidneys, or particularly of the ureters. It was established that aristolochia was associated with those cancers because of the adducts; it was shown that there were aristolochic acid adducts with the DNA, and that aristolochia was in fact the cause of those. The result was that in virtually every modern regulatory system, aristolochia has been banned.

    More recent ones are kava, which is associated with an hepatic toxicity type of thing. And in the case of ephedra, severe limits have been put on its use because of severe adverse effects associated with its use, particularly at higher doses, or prolonged periods of time, or under inappropriate conditions, from which individuals have died.

    Therefore, Health Canada does not consider them to be safe, by definition. We want to see the evidence that they are safe and effective and of high quality before we authorize the manufacturer to sell those products in Canada.

    The Chair: Thank you, Dr. Hill.

    Madame Scherrer.

[Translation]

    Ms. Hélène Scherrer (Louis-Hébert, Lib.): I know very little about the pharmaceutical industry. I'm a consumer and when I purchase a drug, I read the label carefully, along with the potential side effects listed. However, on occasion, when consulting the CPS, I've learned that the side effects of a drug, perhaps aspirin, that I had been taking on a regular basis are quite different from the side effects listed on the bottle. Sometimes, I'm left with the impression that the drug I was ingesting without a second thought could do me more harm than good.

    The CPS lists a considerable number of potential side effects for each drug. What tips the balance at some point in time in favour of recalling a drug with potentially serious side effects?

    Secondly, what standards are you held to when it comes to listing side effects on the label? Obviously, the purpose of the CPS is to inform health care professionals. In the case of consumers who purchase a product at the drug store, the most serious side effects of a drug are probably listed on the label. However, not every side effect can be listed on a bottle. How do you decide which ones to list? Furthermore, what prompts you to decide at some point that a drug is so toxic or may prove toxic when taken alone or in combination with another drug that the best course of action is to withdraw it from the market altogether?

º  (1640)  

[English]

    Dr. Christopher Turner: Obviously this is a complex issue, because we do have the full spectrum, from water, say, that very rarely would have an adverse reaction, to something that could very easily kill you. Again, the risks are diverse and also the acceptability of the risks are diverse. If you have cancer, you're much more likely to accept violent vomiting and abdominal pain, but if you have a stuffy nose, you're not going to accept that same adverse reaction.

    In other words, there has to be some decision-making on the part of an informed consumer. I agree with you in terms of access by consumers to simple, readable materials. As a result, for the product monograph, the package insert kind of material that summarizes that information, the guidelines are just now being revised. It should give clearer direction regarding the patient information section especially, in terms of simple language.

    The bottom line is that the practice of pharmacy, the practice of medicine, the practice of nursing in provincial and territorial jurisdictions is really the point of care where that dissemination of information happens. Health Canada is working with manufacturers as well as consumer and patient groups and health professional groups to come up with better ways to disseminate that information.

    It partly goes back to Dr. Fry's question about whether we couldn't have something simpler. At the last session with you, I mentioned a project we have in terms of getting onto a belt-loop type of system--you have your BlackBerry there--where you could both report and access information about the products. Now, that's fine for the health professional who's using it on a regular basis, but for the consumer there needs to be access to simple, consistent information, where they get comfortable with the look and feel of it and then use it consistently.

    Since there's been over the years a lack of consistency in local pharmacies' purchasing different software packages to generate information sheets, when a patient doesn't always go to their usual corner drugstore but visits five or six drugstores, or whichever one is open in the evening, they'll get a different paper every time. So it's difficult for them to figure out exactly what to pay attention to. In addition, usually these software packages issue one or two pages, and obviously they prioritize the information. They put in the high points and don't list everything.

    There are also cultural differences. If you go to Europe, you'll find that patient information leaflets are much more to the point. They don't list everything under the sun because of the litigation environment there. The United States litigation environment encourages every adverse reaction that ever happened to man, woman, dog, or whatever to be included. So if someone challenges them and says, “You didn't tell me this could happen,” they can point to the summary of product information and find it.

    So it's a very difficult area, and I think Health Canada is working to make it simpler for consumers, working with consumer and health professional associations as well as manufacturers to try to make it more consistent, to try to make the sources easier to get at, both for reporting and for access of the information. It's not easy. We're not at the point of care, so we have to work with those groups, involving consumers, engaging consumers.

    In addition, we recently completed a survey of consumers, health professionals, and the media, asking them a few questions: How do you want to find out about new risks? Because we're not going to tell them how. We want to know how they feel it's best for them, remembering at the same time that there's not one Canadian, not one population. They may want it differently in Nova Scotia, where I come from, than in other parts of the country.

    My mother lives in Nova Scotia--I always tell my mother story--and when she goes to the doctor, sometimes her doctor puts her head down on the desk and says, “You know more about this than I do.” It's because my mother is an informed consumer, not because I give her a copy of the CPS. She asks the questions.

    So that's also important, the shared responsibility for safe medicines use. Consumers have to be empowered. They have to ask the right questions. I know my mother does, and sometimes it drives her doctor crazy. Her GP doesn't want her to ask those questions, because sometimes she doesn't have the answers. In these days of the Internet, when everyone has access to a whole range of credibility of information, we have to encourage a credible source. We try to encourage the credible source to be the sponsor, the manufacturer, because they have usually the most resources to focus on their product.

º  (1645)  

    We have to prioritize what we do in Health Canada. There are 24,000 pharmaceuticals on the market, 50,000 medical devices, and hundreds of thousands of others, unlicensed. We have to prioritize, because it would be impossible for us to do it all. By working in partnership, I think we can improve things, and that's what we're trying to do.

    Mr. Rob Merrifield: Just to get back onto drug approvals and how you get a product on the market, can you tell us what is the average cost you charge for a typical drug, to get it reviewed and on the market? How does that whole process work?

    Mr. Brian Gillespie: It varies with the information that is submitted and the type of submission. I don't have that off the top of my head, but I can obtain that information for you on the exact cost for the various types of submissions.

    Mr. Rob Merrifield: Perhaps you can just tell us in broad terms, what are the ratings and what are the criteria?

    Dr. Christopher Turner: If you had asked that question the last time we were here, Marilyn Schwartz, who's the expert in that, could have answered it. Unfortunately, she's not here today, and I have to tell you, we don't usually know those numbers. We can get that information for you. There's a schedule of costs that's transparent and public.

    Mr. Rob Merrifield: But perhaps you can tell me how it would compare with, say, the U.S., Europe, or other countries.

    Mr. Brian Gillespie: I do know it is substantially less than what the U.S. charges, although I don't have the exact difference. I have been at meetings where the U.S. cost has been discussed, and I think it's somewhere in the order of $500,000 for a complete new drug submission, compared with the Canadian cost, which I'm guessing is $100,000 to $150,000. But I could be wrong on that. I actually don't pay that close attention to what it costs from that point of view. I'm interested in the content of the submission.

    Mr. Rob Merrifield: Right.

    If the prices were higher, if you charged more, could you speed up the process considerably?

    Mr. Brian Gillespie: If as a result of that price being higher we were able to obtain more resources to review the drugs, then, yes, it could be speeded up. Our big delay is in the time from when we receive it until a review starts. So in the queue, waiting for a review, once it's in there, our timelines are reasonable--not always, but for the most part they're reasonable. It's the waiting time, because we don't have the resources immediately to put on the drug as soon as it comes through the door.

    Mr. Rob Merrifield: I don't know whether you'd know this answer, but it would be interesting to know, what kind of resources would you recommend to be able to get the queue in a respectful timeline?

    Mr. Brian Gillespie: I couldn't really give you an informed answer on that.

    Mr. Rob Merrifield: Could you supply that to the committee?

    Dr. Christopher Turner: As part of the therapeutics access strategy, and what we call track one, which was the initial work we did in that regard, there were various business cases developed. In addition, we have an external-charging cost recovery initiative ongoing at the present.

    So there is some material that could be provided on it that would give more specifics. Unfortunately, none of us is directly...because we're involved in the clinical assessment part.

    Mr. Rob Merrifield: Fair enough.

    As long as we get the information, that would be fine, Madam Chairman.

    I have a couple more questions. First of all, the Vanessa Young inquiry had some recommendations. I almost see it as being similar to a court. It's not quite the same, but it's almost as compelling. One of the recommendations on adverse drug reactions was that there should be mandatory reporting within at least 48 hours of a serious reaction.

    Can you tell us, have we complied? Where has that gone? What have you done with it? Has there been a review of that whole process? I understand it was supposed to take place a year after the inquiry came out. Where are we at?

º  (1650)  

    Dr. Christopher Turner: With regard to the Vanessa Young inquest and the Ashley Atkinson inquest in New Brunswick, there were somewhat similar recommendations made by the juries. The department's response to the Vanessa Young inquest is public and is posted on the website. Unfortunately, I didn't bring a copy of it with me.

    The work we've been doing in terms of developing strengthened post-market surveillance activities is work that started before the Vanessa Young inquest. In actual fact, many of the things that were suggested were already in development. And the number of pages in the response is quite extensive, so it would be similar to Mr. Robinson's 37 questions to go through and tell you all the things that have been done.

    That's not to say--

    Mr. Rob Merrifield: Well, reporting within 48 hours for serious adverse reactions was one of them.

    Where are we on that one?

    Dr. Christopher Turner: They don't require us to follow the timeframes around international adverse drug reaction reporting, but in terms of enabling Canada to collaborate internationally, it encourages us to use international standards. So that's what we tend to do in terms of the timeframes for reporting. So the timeframes both for domestic and international foreign reports are internationally standardized.

    Mr. Rob Merrifield: Thank you.

    The Chair: Mr. Ménard.

[Translation]

    Mr. Réal Ménard: I'd like to focus on the revised drug approval criteria. In my view, committee members need to be much better informed. Your colleagues explained to us how the process currently works, but could we possibly get a straightforward primer of sorts? I have no scientific background and aside from Hedy Fry and Grant Hill, no one here is a doctor or aspires to become one.

    This primer should be drafted in a way parliamentarians can understand. It should list the criteria referred to when a notice of compliance is issued. I for one find it hard to believe that the therapeutic merits of drugs are not taken into consideration. Perhaps this should be one of the committee's recommendations. You conduct drug reviews. With respect to AIDS, an issue with which I'm a little more familiar, I tabled a motion as far back as 1995, as Hedy Fry will recall. At the time, we re-examined the Special Access Program in the case of emergency drugs. I would think Health Canada is aware of the difference between AZT, Saquinavir and the third generation of drugs.

    Our goal, therefore, is to ensure that concrete measures are adopted to lower drug costs and to prevent the market from being flooded with new drugs. This doesn't mean that legislative or regulatory provisions shouldn't be brought in to make it easier for pharmaceutical companies to conduct research. If it is in fact true that the process of bringing a new drug to market costs $800 million, then community groups, the Bloc Québécois or Health Canada won't be the parties doing this type of research. No, that research will be conducted by the pharmaceutical industry. Research is the industry's bailiwick. However, it is our responsibility to ensure that the criteria employed are sound and that certain drugs never make it to market.

    Criteria other than the therapeutic benefits of a drug must be considered, for example, biocompatibility. As I understand it, a person who takes a drug to treat a intestinal disorder may have some restrictions that other people do not have. Therefore, I feel it's important for us to have more information to understand things a little better. Could you give us some indication of the steps that might be taken to evaluate a drug's therapeutic benefits?

    I'm not asking you for a detailed answer, merely to give the whole matter some thought. Moreover, we'll be hearing from pharmacists, consumers and pharmaceutical industry representatives. As Bernard Landry would say: audi alteram partem. It's normal for people to speak out in a public forum.

    Could you draft a straightforward paper for us, not overly scientific, but thorough nonetheless. I know you're a thorough person, Mr. Turner. If truth be told, three things are known about you: you love your mother, you are known to be a thorough individual and you are never at a loss for words.

º  (1655)  

[English]

    Dr. Christopher Turner: I think we can do that, yes.

    The Chair: Thank you, Mr. Ménard.

    Mr. Barrette, did you want to get into this?

    Mr. Gilbert Barrette (Témiscamingue, Lib.): No, that's fine.

    The Chair: Dr. Fry.

    Ms. Hedy Fry: I'm going to go back to my question on advertising, because I ran out of time and I didn't get an answer. I wonder if you can remember my question and if you can possibly respond to it. The impact of advertising on...and I know you have rigid standards. The question I want to ask is, are those standards appropriate? Are they enough? Should they be relooked at?

    When you think of simple, even over-the-counter medication that can have adverse effects if taken inappropriately, no one advertising a lot of the non-steroidal anti-inflammatories ever talks about seeing your doctor or about what it might mean if you're taking other medications or about what it might mean if you take this and it can cause adverse effects. So a lot of people are running around buying stuff because they think it's going to help them. There is an inconsistency in the advertising that allows for people to use substances, drugs or whatever, that they think are good for them without having any more information about it.

    I wonder whether you think that the current guidelines--and I understand that you uphold them--are appropriate or whether they should be shifted, whether they should be changed.

    Dr. Christopher Turner: In last year's Speech from the Throne there was an outline concerning the renewal of health protection legislation as one of its priorities. The department is obviously aware and involved with that initiative, because with this commitment to conduct public consultations on the proposed new legislation, part of that consultation will be discussion on the issue of advertising and whether the current legislation is still appropriate in today's context--because obviously this is relatively dated material.

    As you say, if you watch television in Canada you see U.S. ads. Can we really control the Internet? There are issues around the current contexts that are different. I think my position today is that I have concerns. I agree with you. I have the same concerns as you do.

    If you look at the current legislation, which really prohibits direct-to-consumer advertising except for the help-seeking and the reminder ads, which essentially are supposed to tell people to go see their doctors and ask questions, it would address your concern if it were adhered to. But industry pushes the margins; advertising companies push the margins. We now have an opportunity, I think, to...I don't want to say fix, but re-evaluate it in today's context. I think that opportunity is there. It's serious, and I think it needs to be taken.

    Ms. Hedy Fry: I'm not picking on anyone, but Viagra is the one that bugs me the most, in that Viagra was there specifically for erectile dysfunction. Now it's there as a performance enhancer. Of course, everyone wants to look slimmer, be better, be sexier, have higher performance levels, etc.

    What does that mean down the road? First and foremost, it's the taking of medication when we don't know what the long-term effects are going to be. That is what I meant, that kind of stuff. We have prevented cigarette advertising and alcohol advertising.

    Dr. Christopher Turner: Obviously with the Viagra issue, it is a prescription drug. There is a learned intermediary. There is a role for standards of practice of medicine and pharmacy in this. But I agree with you, it doesn't seem necessarily to be as effective as it should be. That shared responsibility for safe use of medicine is one of our messages, because I think it is important, and everyone has a shared responsibility.

    Ms. Hedy Fry: It's neither help-seeking nor a price thing. It's a promotional ad, I'm sorry. I think it's pushed the margins far too much. Sorry, guys, but...you know.

    The Chair: I think it's Mr. Merrifield's turn. He has a very short question, followed by a short one by Dr. Hill.

»  (1700)  

    Mr. Grant Hill: I'll take Mr. Gillespie back to his comments about the three major natural health products you took off the market. You said to me that they had major complications, major side effects. It seems to me that's the purpose of your regulatory agency and I applaud you for taking those products off the market.

    Take me back to melatonin and explain to me what major problems occurred with that product.

    Mr. Brian Gillespie: When I mentioned taking those three products off the market...prior to the serious adverse effects having been identified, they were accepted as being safe because of their long traditional history of use. In other words, they had not been rigorously reviewed as to safety. They were there as traditional products, except for the ephedra, which was there as a nasal decongestant at certain doses and certain duration of use.

    These products, after use--and in the case of aristolochia, probably thousands of years of use--were identified as having very serious problems. Therefore, the premise is that until you study a drug, whether it's a natural health product or a conventional pharmaceutical product, you do not know what those serious adverse effects may be, or if it has any, nor do you know if it's efficacious. And because we regulate the manufacture of drugs, we had no information on the quality of the drugs as well.

    Mr. Grant Hill: By that logic, you're telling me that you take every single natural health product off the market until you have that information.

    Mr. Brian Gillespie: Health Canada has a policy at the present time on traditional herbal medicines. If there are references to support its use for a specific indication--these are traditional herbal references--if the indications are for minor, self-limiting conditions that the average consumer can self-diagnose and self-monitor, and if there's no recent evidence against safety--then that drug will be permitted as a natural health product.

    Melatonin did not have any history of use over the millennia, if you wish, as a natural health product. It is something of the modern age, a hormone that has been extracted. In fact, it can't really be commercially extracted and used. It has to be synthesized, because the quantities present in either animal or human brains is so small it would be uneconomical to extract it. Therefore, all melatonin products present on the market are likely synthesized and not derived from natural sources per se. It did not have that long history of safe use as a traditional medicine.

    Mr. Grant Hill: Since it is now being used in other jurisdictions, how long will you wait to look for adverse reactions in those other jurisdictions before saying it has adverse reactions or not?

    Mr. Brian Gillespie: The current food and drug regulations require that a manufacturer present to us adequate data or evidence that the product is safe, effective, and of high quality. Until we get it, under the current regulations, we cannot authorize it.

    What will happen under the new natural health product regulations I don't know, because I have not examined them in detail. That question would best be addressed to someone in that area.

    The Chair: Actually, natural health products are not within the parameters of this study. I know it tied into today's discussion, but in future we're not going to talk about natural health products.

    Mr. Rob Merrifield: It's hard to separate.

»  (1705)  

    The Chair: I know it's hard, but this is the prescription drug study. We have nine or ten parameters that are quite broad enough.

    Did you have another one, Mr. Merrifield?

    Mr. Rob Merrifield: No.

    The Chair: I still want to go back to this advertising that we started with. It asks when does Health Canada investigate suspected advertising violations, and halfway through it says Health Canada prioritizes its compliance and enforcement actions on the basis of hazard. This suggests to me you're trying to get compliance from pharmaceutical companies who are trying to push the envelope. You are trying to pull them back.

    Is that really your job--to try to teach pharmaceutical companies what is acceptable and what isn't, to try to coax them into compliance? I thought your job was just to make sure the prescription drugs were safe and had proper information with them as they're dispensed. I don't understand why you would spend five minutes trying to get a pharmaceutical company to comply and would operate only on the basis of hazard when the rules are so very, very clear.

    Is the key word “prioritize” because you don't have enough people to go after them? Is that why you have to have a criterion like “hazard”?

    Ms. Danièle Dionne: I think it's part of the answer, the resource level. Of course, when you prioritize...as you said, you may not even spend five minutes on this, and that's what may happen at the end of the day. We have all these other priorities in terms of health mitigations that we need to consider, so unless this is a very high hazard, because of the resources we have, we wouldn't be looking into it per se.

    The Chair: I understand.

    So what you're saying is that because 99% of your activities are based upon trying to keep Canadians safe and healthy, that's why there's this criterion of hazard--because that's the way you think in your department--it's all about health and safety for Canadians. The question of direct-to-consumer advertising is a question of business, or philosophy. It really doesn't fall into health and safety.

    So would you agree that maybe the whole thing about the enforcement of advertising would be better placed somewhere else, like maybe in the Department of Justice, or the Competition Bureau?

    Ms. Danièle Dionne: That's a very good point, of course, because the Food and Drugs Act addresses health and safety matters. DTC nowadays touches on other kinds of domains, such as trade. So I think we will need to look at how best we can enforce that domain in Canada and where it is best placed. I'm not sure it fits in the health-and-safety-only approach. I think the scope is much greater than that right now.

    The Chair: For example, there could be a true piece of advertising that in your judgment is not hazardous to Canadians and is therefore allowed to stay on television under the pretext of being an information message, but it is really breaking the two rules, and you wouldn't yank it. So the company goes on to make a million dollars because of this very appealing ad.

    Ms. Danièle Dionne: But we would take action when it represented an infraction that could cause some harm for a consumer.

    The Chair: But what if it didn't?

    Ms. Danièle Dionne: When it doesn't, it makes it more difficult for us in this branch to elevate it as a priority.

    The Chair: But if somebody is actually breaking the law.... You see what I'm saying. I think you agree with me.

    Ms. Danièle Dionne: The Food and Drugs Act is a health and safety act in terms of public health. To bring this aspect in makes it more difficult, I find, and it's more difficult to operationalize as well. So there are other considerations that need to be brought forward.

    The Chair: I would say this is why direct-to-consumer advertising is an issue, because the context within which we're looking at it, that it has to be measured against hazard or health and safety, is probably not adequate if in fact we have a strong philosophical position on the issue.

»  (1710)  

    Ms. Danièle Dionne: I would say it's not enough.

    The Chair: Are there any other questions?

    Seeing that there are none, on behalf of the committee members, those present and those who had to leave, I would thank you very much for your responses and for your written answers as well.

    This meeting is adjourned.