HEAL Committee Meeting

STANDING COMMITTEE ON HEALTH

COMITÉ PERMANENT DE LA SANTÉ

EVIDENCE

[Recorded by Electronic Apparatus]

Thursday, March 26, 1998

[English]

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The Chair (Ms. Beth Phinney (Hamilton Mountain, Lib.)): I'll call the meeting to order.

This is the 32nd meeting of the Standing Committee on Health. We are doing a study on natural health products. Today we have an individual who is not here—

A voice: She just came in.

The Chair: Maybe we could go ahead with the group we already have, from the Food and Consumer Products Manufacturers of Canada: Laurie Curry, who is the vice-president; and Dr. Richard Black, who is the director of scientific and regulatory affairs.

I want to introduce the other witness, another individual who will be speaking to us, Dr. Michèle Brill-Edwards.

We'll give Dr. Brill-Edwards a few minutes to get her breath, and we'll start with the Food and Consumer Products Manufacturers group.

Before we start, I would remind the committee that we have a working meeting on Tuesday, so over the weekend you can start thinking about the directions in which we're going and how you feel about it.

Okay, go ahead.

Ms. Laurie Curry (Vice-President, Public Policy and Scientific Affairs, Food and Consumer Products Manufacturers of Canada): Thank you. Good morning. I'm Laurie Curry, vice-president of public policy and scientific affairs for the Food and Consumer Products Manufacturers of Canada. I am joined today by Dr. Richard Black, and I'll have him introduce himself.

Dr. Richard Black (Director, Scientific and Regulatory Affairs, Nestlé Canada; Chair, Committee on Health Claims, Food and Consumer Products Manufacturers of Canada): I'm Richard Black, director of scientific and regulatory affairs with Nestlé Canada, assistant professor of nutritional sciences at the University of Toronto, and I chair the FCPMC committee on health claims.

Ms. Laurie Curry: Thank you.

The membership of the Food and Consumer Products Manufacturers of Canada, or FCPMC, includes over 180 companies, located coast to coast, involved in the manufacturing and marketing of food, beverages, and consumer products sold through retail, grocery, drug, convenience, mass merchandise and food service distribution channels. This sector represents approximately $11 billion in total sales and 13% of the manufacturing gross domestic product.

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The food and consumer products industry employs over 250,000 Canadians and is committed to growth both domestically and in our export markets. FCPMC appreciates this opportunity to appear before the standing committee to present the position of our member companies.

Basically, the time for change has arrived. Consumers are demanding products that will help them achieve a greater level of well-being, and industry is unable to respond to the needs of the marketplace because of the outdated restrictions still being imposed that limit potential business growth and job opportunities in the area of new product development.

FCPMC recognizes that the committee has heard from many diverse, and no doubt conflicting, points of view regarding the health benefits of herbs, botanicals, and foods, and the means by which they and the health claims associated with them may be regulated.

We are here on behalf of the food and consumer products industry to provide the standing committee with what we believe to be a viable option in the development of a regulatory, or even a legislative, framework to effectively govern the use of health claims in the marketplace.

Our option is principle-based, and it will allow consumers to make informed choices by ensuring that current health and safety considerations are met, maintaining truth and integrity in consumer communications so as to not mislead the consumer, and last, promoting fair competition in the marketplace.

We propose three main criteria in this brief, which we will expand upon.

First, FCPMC believes that it is unnecessary to create a new regulatory category for natural health products.

Second, FCPMC believes that by permitting, and distinguishing between, three different types of claims—these are structure and function, risk reduction, and therapeutic claims—safety can be assured while maintaining and enhancing the consumer's right for choice.

Third, FCPMC believes that it's important to develop equal regulatory status among drugs, herbs, teas, botanicals, and foods, thereby ensuring that consumers can be informed of the health benefits on the widest possible variety of products.

We believe that a new regulatory category is not required. Currently, there is a grey area between the two existing categories, which is food and drugs.

What will happen—this has been suggested by other organizations and committees—is that a third category will be created. Clearly, this will lead to more grey areas, resulting in further confusion, and in the long term, likely more regulatory bureaucracies and restrictions than those we currently have.

FCPMC also believes that it's unnecessary to develop a regulatory definition of natural health products, nutraceuticals, functional foods, or any other designations that are currently being used in addition to the terms food and drugs. Today, the concept of a food-drug continuum is generally accepted, and therefore the need for more definitions becomes redundant. More definitions equate to more confusion, particularly when products straddle or overlap rigid definitions.

Just as an example, let's take oats, particularly its constituent, beta glucan. Beta glucan has been shown to reduce cholesterol levels and therefore the risk of heart disease. The health benefits related to oat consumption can be realized in a number of ways. For example, consider the consumption of traditional oatmeal. There's oat bran, which is naturally high in beta glucan and can be used for breakfast cereal or with other ingredients in a variety of healthful foods, such as muffins or a satisfying beverage. Also, one can consume a high beta glucan supplement.

The question then becomes: when do oats stop being a food and start becoming a natural health product or even a drug? More specifically, when consumed, when did the oats stop nourishing the body and begin contributing to lower the risk of heart disease risk or becoming an integral part of the diet management for high blood cholesterol? From a scientific as well as a Canadian consumer perspective, they never did. Only the need to comply with unnecessary definitions has clouded the issue and created the confusion.

In light of the above recommendation and example, the question now is, how should health claims be regulated? Current thinking dictates that what a product is should determine what type of health claim can be made. FCPMC recommends that addressing the problem from the other direction—that is, defining and regulating the health claims—we believe will eliminate or resolve the majority if not all the issues before this committee.

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FCPMC is recommending that health claims be divided into three general categories. These categories are not new. They have been widely agreed upon and presented to this committee by others. These three categories have also been proposed by the therapeutic products directorate in their policy options paper. They are, first, structure and function claims. I'm not going to define them, but the example here is “calcium helps build strong bones”. For the second class of claims, risk reduction, the example here is “folic acid will reduce the chance that your child will be born with a birth defect”. And last is therapeutic claims, the example being “dietary fibre can relieve constipation”.

These claims could be applied equally across the whole food and drug continuum and controlled by appropriate regulations covering the essential criteria that must be met. The essential criteria are: Is there clear evidence that the product is safe? Are there any issues surrounding the use of the product, and if so have they been made clear to the consumer? And lastly, is the efficacy of the product supported by strong, clear scientific evidence and communicated in non-misleading language appropriate for Canadians?

People may argue that therapeutic claims cannot be handled in the same way as structure and function claims. Again, FCPMC disagrees and believes that the degree of risk is the crux of the issue. The greater the risk, the more tightly controlled the product must be. The greater the risk, the more careful we have to be in how the product is used. And the greater the risk, the more thorough and complete the science has to be to validate the claim.

More and more, Canadians are taking a much more active role in their own health care. They are not just self-diagnosing and self-medicating minor illnesses any more, such as a headache or a minor cold, but are actively making diet and lifestyle choices to optimize their health in order to improve their quality of life. FCPMC believes that the availability of safe, effective products making proven health claims will provide a significant benefit to Canadians. Of course it is a given that there will remain diseases that require the managed care of a health professional. And it follows that there will be products making very specific health claims, for example drugs used in the therapeutic and chemo-therapeutic treatment of cancer, that should only be used as part of a treatment regimen supervised by a qualified health professional, and where warranted their promotion should be directed only to a qualified health professional.

This simple and effective system based on the regulation of claims would leave intact the current definitions for food and drug that are currently entrenched in the Food and Drugs Act, but would require a regulatory amendment relative to section 3, schedule A of the act. We'd be willing to elaborate on the proposed amendment in the question and answer period at the end of the presentation.

FCPMC believes that by regulating the health claims, as opposed to developing artificial, restrictive categories requiring costly regulatory bureaucracy, it is possible to ensure a consistent regulatory framework regardless of a product's form. This approach ensures that Canadians have access to product information that may help them achieve better health. One person might eat oatmeal, and another might take a supplement. If orange juice is high in folic acid and folic acid reduces the chances of heart disease, then Canadians should know this. If green tea as an herbal has been proven to reduce the risk of skin cancer, then Canadians should know this too. We do know that aspirin can reduce the risk of a heart attack, even though most Canadians take it for pain relief. Why is it that just because it is eaten for breakfast we prevent Canadians from knowing that a high-fibre breakfast cereal might help prevent colon cancer?

The answer is that Canadians should be allowed to make informed choices. This, however, calls for a consistent regulatory framework that is evidence-based, with the scientific justification bar being raised in accordance with the type of claim being made.

In summary, FCPMC recommends only one option be pursued—that is, regulating health claims. This includes both the type—as I mentioned earlier, the structure and function, risk reduction and therapeutic—and the level of evidence required to substantiate such claims. This option will continue, we believe, to uphold Canada's reputation for a sound and strong food and drug regulatory regime. It will also allow Canada to carve out a leadership role, one that it enjoys now, in the international regulatory arena. After all, this is what the world and Canadians expect from us.

Thank you.

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The Chair: Thank you very much.

Dr. Brill-Edwards.

Dr. Michèle Brill-Edwards (Individual Presentation): Thank you, Madam Chair.

Members of Parliament, ladies and gentlemen, my name is Dr. Michèle Brill-Edwards. I'm here at the invitation of the committee and out of respect for the importance of this issue to the Canadian public.

I am a physician and an expert in the science and medicine of drug development and drug regulatory law in Canada. I was previously with the Health Protection Branch, and I resigned my position two years ago, specifically in order to be able to speak out about abuses of the Food and Drugs Act that I was witness to as a senior regulator, on a repeated basis.

The specific incident that prompted my resignation was the mismanagement of the calcium channel blocker health hazard. This is a family of heart drugs. I have presented previously at other committees on this issue, and I have attached and will table the previous briefs presented.

In essence, I'm here to make three points: first, to remind you of the intent of the Food and Drugs Act to protect the public; secondly, to point out the contradiction of lax regulation of high-risk products versus overzealous regulation of low-risk products, which is your mandate; and thirdly, to recommend to you an investigation of the Health Protection Branch.

First, as to the intent of the Food and Drugs Act, in a very simple and eloquent way, in the foreword to the act, the intent is stated. It is: “to protect the public”. That's a very important phrase to remember. It is not to serve the pharmaceutical industry; it is not to serve political and commercial needs. It is there to protect the public. From what? From health hazards and fraud in the sale and use of foods, drugs, cosmetics and devices. And I would urge you to keep that as your central guiding principle in all your deliberations.

There are a couple of important features. The Food and Drugs Act must be upheld by the Minister of Health and the Health Protection Branch. That is part of the enabling legislation setting out the duties of the department. So the upholding of the act is not discretionary; it is compulsory. And it must be applied in a fair and even manner across the board.

Furthermore, the act is part of Canada's criminal law, so dereliction of duty to uphold this act can potentially constitute criminal negligence, because it leads to bodily harm and death and fraud.

Next, in terms of how this act is applied and your mandate to review the regulation of natural products, I can't emphasize enough that the contradiction that faces you as a committee is the stark contrast that many citizens have brought to your attention, the lax regulation of high-risk products such as blood, such as prescription drugs, including nifedipine.... The list goes on, and I won't enter into that long list, but contrast this with the very overzealous, rigorous regulation that sees cayenne pepper in capsules as a full drug risk. It doesn't make sense.

What accounts for that kind of illogical, uneven approach to the application of the act? Who does it serve? It certainly does not serve the Canadian people, and you've heard that abundantly. In essence, that contradictory approach serves the pharmaceutical and nutriceutical industry, because deregulation of high-risk products really leads to a downplaying of risks for prescription drugs and biotech products—the products that carry high risk.

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When we downplay those risks, we widen the market for those products and we allow them to remain on the market, bearing profit, long after evidence of harm has come about. That, by the way, is against the Food and Drugs Act.

By contrast, the high or zealous regulation of low-risk products also benefits the pharmaceutical industry by creating impediments for small manufacturers to stay in the natural products industry, thus clearing the way for the larger traditional companies to take over that burgeoning market. If there's any question in your mind about whether this is a burgeoning market, look at the web site for Agriculture Canada and the documents on the burgeoning nutriceutical market. Look at the document produced recently by the World Bank on medicinal plants, showing that there is concern about the preservation of natural products in developing countries because of the upsurge of demand in developed nations for those same products. This is a marketplace story.

What is your mandate as a committee? Your mandate is to examine the regulation of natural products. But when you have evidence coming before you of this kind of misapplication of the act, this kind of uneven application of the act, I submit to you it causes you to then be responsible for addressing a larger mandate—to go beyond the strict consideration of how we will regulate natural products and to address the application of the act in principle.

We can discuss—and I would be happy to discuss with you—possible solutions for natural product regulations. I agree with much of what has been said here: that the key fundamental issues are to commit to the notion of low-level regulation for low-risk products; to look at and define the procedures for claims for foods.

It's not rocket science. Yes, it's complicated, but it's not impossible. Re-commit to quality control as the number one safety feature for the regulation of natural products and other low-risk products. Re-establish the capacity of the department to ensure quality control. Re-establish the food labs, re-establish the drug labs, and especially the natural products section in those labs.

But that's a very narrow mandate we're speaking of, and I perceive that this is not the most important thing you must do as a committee. The most important thing you must do as a committee is to address this uneven application of the act, because no matter how you try to tinker with the act or change the act, you haven't altered the culture of the department and the culture of the Health Protection Branch that allows this kind of uneven, and in my judgment, in my experience, unlawful application of the act.

In and of itself, uneven application of the act warrants a call for investigation by this body. But more and more, particularly in the past year, there is a second feature of the functioning of Health Canada that in my judgment compels you to bring about a public investigation, and that is the pernicious nature and broad scope of what I will term the culture of deception in the branch.

We now have, within the last year or two, abundant evidence that senior officers of the branch, of the department, are misleading the public on serious matters such as the closure of our food and drug research labs. There is outright misleading of the public. We have evidence of ministers being misled. And as recently as February 28 of this year we have abundant evidence of this very committee being misled by statements that are half-truths and outright misinformation.

My point to you is that if, as members of Parliament, you fail to come to grips with this climate, then you will have failed in your overall mandate as the Standing Committee on Health. Before you make a decision as to whether you will investigate, I would ask you to think about not so much the commerce, which is a legitimate part of Canadian life and has been talked about a great deal here, but I would ask you to think about the individual Canadians whose lives are destroyed when the Health Protection Branch does not administer the act evenly and fairly.

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I would ask you to think about Joseph Gil. In the weeks that I was contemplating resignation to prompt, to force, a warning about the calcium channel blockers, Mr. Gil went to his doctor, was found to have severe high blood pressure, was given nifedipine, and had a catastrophic stroke within 48 hours. His life is destroyed; his family's life is destroyed; he's an invalid for the rest of his days.

Think about Brian Baskin, who received hepatitis C through blood. But worse yet, he was a blood donor, giving plasma twice weekly for more than two years prior to the time the Red Cross discovered that he had active hepatitis C. When he asked to have his donations traced so as to be able to notify the people who deserved to know that they had received blood product from him, he was told to forget it. He was actually told that if he pursued the issue he would face lawsuit from the Red Cross. That's despite the fact that Canadian law, the Food and Drugs Act, criminal law, compels the manufacturer to notify the department about risks like that and provides the department the authority to deal with those risks. So consider that when you're making your decision as to whether you would investigate.

Lastly, I would just say to you that if you choose not to investigate or not to bring about an investigation of the Health Protection Branch in the face of uneven and unlawful application of the act and in the face of pernicious and repeated misleading of the Canadian public and you, a committee of Parliament, by senior officials of government, then I suggest we all go home early, because it would make this process a façade. It would make it redundant and irrelevant if in fact this level of misapplication of Canadian law and this level of suffering amongst Canadian people are of no consequence to a committee of Parliament.

Thank you.

Voices: Hear, hear!

The Chair: Thank you very much.

Dr. Hill, would you like to begin?

Mr. Grant Hill (Macleod, Ref.): I thank all of you for presenting. I'll ask a question to Dr. Brill-Edwards, if I might, first off.

We have heard that one of the problems with the HPB is that the scientific capability is still good and yet the administrative capability has been overtaken by, if I might call them, in quotation marks, “business types”. We did actually hear that in years gone by.... The name of Dr. Morrison came up as the leader of the HPB, as having a scientific background and the ability to assess and correct the HPB in a much better way. Do you concur that the department is skewed in that way?

Dr. Michèle Brill-Edwards: I not only concur; if you're at all interested as a committee, I can demonstrate to you nearly a decade's evidence of the systematic disappearance of medical and scientific expertise from the branch, facilitating this whole policy of deregulation. The outcome is exactly as you've put it: that what we are running now is a business and not a health hazard management group, because the people at the upper levels don't understand or have familiarity with the Food and Drugs Act as it marries with medicine and science, and there's no intention to have that capability in the department.

A committee of consumer watchdogs over blood regulation met with the department last summer and were appalled to realize that there are no blood specialists in the bureau of biologics. There is no doctor who is a specialist in transfusion medicine helping after the blood scandal. That's appalling. The department didn't think that was appalling at all; they justified it and said, “What do you want? If we had a specialist like that, what would you want? Would you expect them to be the director?”

So you see the competition now between the so-called managers, who don't have the expertise to do their jobs properly, versus the threat of bringing on board qualified people who would then have a reasonable say in the wise decision making of the department.

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Mr. Grant Hill: Presuming the HPB does get investigated or altered, where would we look for an HPB in another jurisdiction that is not run in the same way?

Dr. Michèle Brill-Edwards: I think you have to be cognizant of the changes in regulation worldwide roughly over the past two decades. We've come through a period of prolonged deregulation. Almost all agencies in the developed world have been subject to the same pressures that we've seen in Canada. The constant business cry has been to speed up the approval process, don't worry about health hazard management, and get rid of the expertise that could stand in the way of business decisions.

I would say that if you want to choose one or two agencies that have survived battered but intact, I would probably advocate the FDA. But remember that the FDA functions in a political climate in which there is a very strong investigative approach among members of Congress who support the need for public protection.

There are members of Congress, such as Waxman, who are more knowledgeable about drug development and the science and medicine of regulatory law than most doctors. Be careful when you look to other models to see those models in their local context.

Mr. Grant Hill: I don't detect any political component in what you've said. I don't detect any of your comments as being directed at the government or a political party. I detect that your comments are directed at the bureau itself. Because it's in a committee sense, it sometimes becomes protective if you will, turf protection. Could you make me comfortable that you aren't talking about politics but are talking about...?

Dr. Michèle Brill-Edwards: There's no doubt that policy enters into this issue.

The internal nickname of the branch—this is the nickname of the people within the branch—for some time has been the self-protection branch. That reflects any bureaucracy defending its own conduct regardless of what the facts may show. It exists independently of political interference. I want that point to be very clear.

If you're asking me if there is also political interference, the answer is that in my experience there is no question there is political interference in a very subtle, sophisticated, and difficult-to-track manner. The political interference comes basically from the cabinet level and the influence on various ministers, not simply the Minister of Health, to alter policies in a manner that benefits corporate interests.

The Chairman: Madame Picard.

[Translation]

Ms. Pauline Picard (Drummond, BQ): Good morning and welcome. My question is directed to Dr. Brill-Edwards. By the way, I want you to know that I feel you're very courageous to have presented this evidence today. Thank you.

I have a lot of questions to ask, but I will select one. This week, we saw a group which made quite a contradiction obvious to me. It was the International Development Research Centre which is funded by the government. This organization gives grants to scientific laboratories in developing countries where, in some communities, in consultation with shamans, research work is done on plants that may be used to treat people. In developing countries, drugs provided by pharmaceutical companies are too expensive. So, they develop, according to the culture of each community, products so-called natural which are safe for these people.

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Here, we dismantle all our laboratories, we dismiss our scientists and we say that it's not efficient. We have problems to find a way to have these natural products approved. Could you please comment on that?

Dr. Michèle Brill-Edwards: Thank you very much.

[English]

I will respond in English, only because it's easier for me.

I was just looking for a report, which I can dig out in a moment. It's a report of the World Bank on the very subject you are speaking about: the effort internationally to preserve and enhance the capacity of developing nations to produce their own natural products, for two reasons. First, those products are valuable worldwide and are also a valuable form of commerce; but second, and more importantly, in developing countries those natural products are the only source of treatment for millions of people in the world.

You are absolutely right. It is a huge contradiction that while the world is recognizing the value of natural products in a broad and general sense and while parts of our own government are attempting to enhance that recognition, we have the Health Protection Branch throwing the regulatory book at these products and making it almost impossible for some of the smaller herbal manufacturers to stay in business in Canada.

Again, I go back to the only hypothesis that makes sense out of that contradiction: the pharmaceutical industry benefits by being able to clear the way in the natural products area for their own domination of that emerging market. There's no question that the natural product sector, if you will, is the burgeoning, emerging profit centre of this decade for pharmaceuticals and nutriceuticals.

The Chair: Ms. Caplan, you have five minutes.

Ms. Elinor Caplan (Thornhill, Lib.): First I'd like to address Dr. Brill-Edwards and say that nothing makes me angrier than being misled, particularly when I'm being misled by half-truths.

I would like you to present to the committee any evidence you have that this committee has been misled. I'm not going to ask you to address that now, but you said you have the information and I think we would all like to have it.

The Chair: Send it to the clerk and he can distribute it.

Dr. Michèle Brill-Edwards: I will certainly make an undertaking to provide it to you in writing, because it has been prepared, but I would ask for an equal and reciprocal undertaking. I would like a response from the committee rather than have it drift into orbit, never to be seen again.

Ms. Elinor Caplan: I think I could speak for all members of the committee. They are probably as upset as I am at the idea of being misled or deceived. We would take very seriously any evidence you could produce and would be happy to reply. Certainly I feel that way, and I don't see anybody around the table who would disagree with it.

I do want to spend the time we have available on the issue before us today. That is how and what Health Canada's role should be and who within Health Canada—and if there is a box, where the box should be placed.

I would address my question to Ms. Curry.

You say you don't believe there is any need for regulation. Who would decide what is safe, who would decide what is good quality, and who would decide what is said to be in the bottle is in the bottle? Who would decide, within your presentation, what claims and evidence are appropriate and legitimate? For me it's a question of who in an unregulated environment decides the questions you raise on page 3. How would consumers be protected?

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Ms. Laurie Curry: First, let me clarify we're not looking for an unregulated environment. We're saying currently there's a definition of a food and there's a definition of a drug. Foods are not permitted to make health claims.

Ms. Elinor Caplan: It's my understanding that the minute you make a health claim or decide to stay under the category of foods, you have the problem of meeting the international Codex standards.

Ms. Laurie Curry: As soon you link a food to any of the diseases listed in schedule A of the Food and Drugs Act, it becomes a drug product, and that's where the grey area is.

Ms. Elinor Caplan: Do you want these products evaluated as foods and, if so, are you concerned about the impact of the international standards of Codex? Are you concerned, as I am? If you're not concerned about that, products that are thought to be low risk will have the drug process applied to them. Are you concerned about that?

Ms. Laurie Curry: We're saying there's a food-drug continuum. When you start making claims, we're asking that you regulate the claims. When you regulate the claims and the types of claims.... When you move between a structure and function claim and go toward a therapeutic-type claim, the standard of proof that's required as you move along that continuum has to increase.

Ms. Elinor Caplan: I understand that, but you're saying you want Health Canada or TPP or the the food directorate.... All I want to know is who you think should do this regulation of claim. Do you want GMPs for quality? Are you concerned about safety, toxicity, and so forth?

Dr. Richard Black: Let me jump in. I'll go back to the reference you made earlier to Codex. The issue of health claims and Codex has not been resolved yet. It's what they call “in square brackets”, I think. It's still out there, although it's being debated.

Ms. Elinor Caplan: We don't want to wait—

Dr. Richard Black: Absolutely not.

If we were to permit health claims for foods—and the document is being submitted to this committee I suppose by the end of next week through translation—there's a way to do it through governor in council. You can exempt foods that meet certain criteria from certain proportions of the regulations or the act. You would be able to develop quite easily a regulation that would permit health claims on foods without pushing the food into a drug area.

There's the first answer to your question.

Ms. Elinor Caplan: What would be the impact of Codex on that, since the jury's still out on foods? What would be the impact of the Codex standards on those?

Dr. Richard Black: It's a labelling issue for Codex. When you ship your product out of the country, you're going to re-label it anyway for the country of destination. If you want to put a health claim on it and it's legal in that country, you'll be allowed to. If you're going to abide by Codex definitions and regulations on food labelling, you won't put your health claim on that product.

Ms. Elinor Caplan: Are you saying Canada should or should not abide by the Codex international standard?

Dr. Richard Black: I think Canada should be a party to Codex discussions. I don't think Canada can be led by Codex, but it could take an active role in leading Codex.

Ms. Laurie Curry: There were the comments we made about the opportunity for Canada to take a leadership role in the international regulatory arena, because it has not yet been resolved by Codex. Canada as a country has been looked to in a leadership capacity around labelling in other nutrition areas. Canada chairs, through Dr. Anne MacKenzie from the Canadian Food Inspection Agency, the Codex labelling committee that meets on an annual or every other year basis.

Ms. Elinor Caplan: What about safety and GNP standards?

Dr. Richard Black: As the risk escalates, I think you can move it into therapeutic products. I don't necessarily mean regulated as a drug. I'm saying they have the structure if we get the right personnel in there. I'm not in a debate whether they are or not currently. They have the structure in place that would allow a check to the valuation of increased risk products. There is a risk benefit.

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The Chair: Thank you, Dr. Black.

Ms. Wasylycia-Leis.

Ms. Elinor Caplan: Can I make a comment and not ask a question? I'm only trying to understand what he said.

The Chair: We'll have to take a vote here. You're about four minutes over.

Ms. Elinor Caplan: Could I have a minute or less?

Ms. Judy Wasylycia-Leis (Winnipeg North Centre, NDP): Yes, if I can add a minute to mine.

The Chair: Sure.

Ms. Elinor Caplan: What I understand you saying is that you want any regulation done by existing TPP.

Dr. Richard Black: And foods. We'll stay in foods.

Ms. Laurie Curry: One of the difficulties is that the directors have been set up according to how the act is set up. You have a definition for a food and a definition for a drug. You have the food directorate and you have the old drugs directorate. As we go into the future, I think we'll have to look at how you bring the expertise to bear and look at the approval system.

Comments were made earlier about scientific evidence and whether Health Canada has the capacity from a scientific perspective to evaluate these products. One thing I think we have to look for in the future is partnerships—academic, government, industry partnerships—to look at the science and look at it from a global perspective. From a research perspective, it can't be Canada-centric either. We have to look at how we tap into the expertise in the areas and where they are. It may not always be the experts in Canada.

The Chair: Okay.

Ms. Wasylycia-Leis.

Ms. Judy Wasylycia-Leis: Thank you, Madam Chair.

I'd like to direct my questions to Dr. Michèle Brill-Edwards, who has made some very serious allegations before this committee. I remind all committee members that these are not new allegations. I can't begin to add up the number of people who have appeared before this committee and made very strong remarks about the Health Protection Branch.

I think it's absolutely critical that we as a committee deal with this. Otherwise I don't think we'll be able to complete our work in terms of a regulatory process for natural health products, nor will we be able to address the underpinning of all of this, which is scientific expertise within the branch.

I would like to ask four specific questions pertaining to areas where I feel we have not had straight answers from the department. I think this will help in the pursuit of this issue.

The first question pertains to the closure of the drug research lab. Time and time again we've asked it. The answer that has come back from Dan Michaels in the Health Protection Branch is that we have exactly the same capacity within the therapeutic products program for research and laboratory support to the biological area and to the testing capacity across this country as we had before.

Dr. Michèle Brill-Edwards, is that true or false?

Dr. Michèle Brill-Edwards: I would like you to read the last phrase there—“the same capacity to”...?

Ms. Judy Wasylycia-Leis: The same capacity across the country as we had before we made the organizational change of eliminating the Bureau of Drug Research.

Dr. Michèle Brill-Edwards: That was the capacity to regulate biologics, I think.

Ms. Judy Wasylycia-Leis: We've raised this several times with Dan Michaels, both in terms of biologics and of pharmaceuticals generally. The answer each time has been the same: that we have not lost any capacity to do our job in that area.

Dr. Michèle Brill-Edwards: I think what you're dealing with here is a very clever half-truth. Mr. Michaels refers repeatedly, and I've gone through the transcripts of his testimony in detail, particularly February 28.... He repeatedly refers to the capacity for research in the area of biologics, which is the one area that was protected from the cuts. That was largely because at the time this decision-making was going on, the Krever inquiry was under way and any cuts to biologics would have been front-page headlines.

To me, this is misinformation to the committee. He has not acknowledged to you, particularly as a committee studying natural products, that we have no capacity to do any new research into the quality and toxicity of natural products. All we have left are some analytical labs in the regions that can do routine testing of known entities, but there's no capacity for independent investigation of new hazards.

Ms. Judy Wasylycia-Leis: Thank you.

The second question pertains to this committee's inquiry about the former natural products section of the Health Protection Branch. When asked about it, Mr. Dan Michaels said “We never had a natural health products lab”. Is that true or false?

Dr. Michèle Brill-Edwards: It's categorically false. There was a natural products section within the chemistry division of the Bureau of Drug Research. It was a section; we roughly speak of it as a laboratory. It's not one lab but a cluster of laboratories. This section was engaged largely in the investigation of particular hazards relating to natural products. They had other work to do with antibiotics and other drugs, but in the late 1980s and early 1990s more and more of their work centred on natural products, because even then it was recognized as an emerging market that needed investigation.

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Interestingly, when that laboratory was closed in 1991, there was an outcry, not just in Canada but from abroad. There are abundant letters showing us that people were writing to the minister and prime minister of the day saying please don't disband this, it's not just a national resource but an international resource, they're doing ground-breaking work that's valuable at an international level.

The person who defended the disbanding of the section on CBC Radio—we have the transcripts—was Mary Carman, who sat beside Mr. Michaels and listened while he told you there never was a lab. How do you as a committee come to grips with that kind of deception?

Ms. Judy Wasylycia-Leis: Third, we've raised the issue of nifedipine before this committee. It's an issue you're intimately involved with and familiar with. We raised it in the context of the perception that there is a less than rigorous approach around approval of high-risk drugs as compared to the very rigorous application of rules around low-risk products. When asked about nifedipine, it was Mary Carman who answered:

Our reports concluded that while there were warnings and precautions that needed to be augmented, the currently approved product for those uses was appropriate.

Can you comment on that?

Dr. Michèle Brill-Edwards: Again, that is categorically wrong. The evaluation of nifedipine over the past years has been repeatedly and persistently inadequate and misleading. It is repeatedly stated by the department that they have had outside expertise apply to the issue and that the expertise is free of conflict of interest. That is not true.

Since 1995 there have been roughly three examinations of this issue by expert groups. The first is the one I resigned over, and the conflict of interest was glaring. The second was an in-house quick review by experts, one of whom was not an expert and who admitted he read the report over the lunch hour before it was printed, having no opportunity to make any changes in the report whatsoever. The second was an expert from Ottawa who admitted to a CBC correspondent that he had a direct conflict of interest. He was engaged in research funded by one of the manufacturers, even though the department has repeatedly said there was no problem with conflict of interest.

The final committee that has reviewed the safety of calcium channel blockers has produced a report that was subjected to a roughly one-year examination. Interestingly enough, this ostensibly extensive report manages to come out with the conclusion that this class of drugs does not have any health hazards that cannot be managed by strict attention to approved indications. That is not true.

In all their work they managed to miss one publication that came out during the course of this investigation. It clearly shows that nifedipine—short-acting, the capsules—under Canadian regulatory law does not belong on the market. The evidence is right here. Interestingly, the study is produced by Bayer and Pfizer.

What's going on when a committee of experts takes that amount of time and money to ostensibly study something in detail and they miss a key article that I can pick up in a literature search on the computer in less than half an hour?

Let me tell you again, the issue is conflict of interest. Was there anybody on that committee who did not have a conflict of interest by conventional standards? The answer is no. But you have been told outright that this committee was golden, that there was no conflict of interest. By whose standards?

Ms. Judy Wasylycia-Leis: My last question relates to this whole area, because we have heard from a number of scientists both within and outside the department who believe they're under pressure from the industry to approve products that are not safe.

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When asked about this, about whether there was undue influence by the pharmaceutical industry over the Health Protection Branch, Mr. Dan Michaels said:

I would adamantly insist that there's no collusion between my organization as regulator and any aspect of the drug or medical device industry.

Do you have any comments on that?

Dr. Michèle Brill-Edwards: Because of the importance of this question of who is the client, I believe this committee has a duty to bring Mr. Michaels back. Read him his own testimony regarding the issue of who is the client of the Health Protection Branch, and whether there is undue industry influence upon the branch because of internal management attitudes, and then ask him how he accounts for this document, which is his document, called Bulletin No. 2, Quality Initiative Bulletin of February 1997 of the Drugs and Medical Devices Program. It answers the question “who is our client?” The answer is—and this is for the staff of the directorate—“your client is the direct”—direct is in bold—“recipient of your services. In many cases this is the person or company who pays for the service.”

This document tells the staff to hurry up, to speed up the reviews and not waste time chasing down clues of harm, to get their work done quickly because they're pleasing the company. You cannot function as a democracy if senior members of government come before you and in answer to the concerns of Canadian citizens deliberately mislead you and tell the committee to relax.

My unit is fully endorsing the concept of the Canadian public as the client of the department. The public is to be protected...

And he launches into a beautiful rhetoric of public protection, but believe me, it's only rhetoric. Inside the department it's very clear to the staff that this pro-industry, serve-the-industry attitude rules the day.

Thank you.

The Vice-Chair (Ms. Elinor Caplan): Thank you for your presentation. We look forward to receiving your written brief. I think I speak for all members of this committee when I say we are very concerned about the allegations you've raised and we will want to pursue this matter.

Ms. Bennett.

Ms. Carolyn Bennett (St. Paul's, Lib.): I agree.

We've been hearing a great deal and I think we've seen some inconsistencies. As a committee I think we have heard enough to feel that....

I have to set the record straight. I've been fighting the Red Cross since I was 16, so I feel there are sometimes problems where you need a fresh look from outside. The deliberations of the committee may take a while. I think we would probably find a consensus within this committee that we've heard enough to think there needs to be an independent look at this. I'm not sure it's appropriate for us to move that today, but I think we should at least assure you that this isn't going to go away, that we will do everything in our power to make sure the public interest is protected, and that this is what Canadians expect of us as government and as a parliamentary committee.

It's only at times like this that we understand the gravity of our responsibility here at committee, and I would ask the chair if there's any direction or whether—

The Vice-Chair (Ms. Elinor Caplan): I think it would be appropriate to receive the written submission from Dr. Brill-Edwards and then for the committee to have a discussion on action they would like to take.

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Ms. Carolyn Bennett: I take Dr. Brill-Edwards' suggestion that maybe we bring back the officials to comment on the report, and then if at the end of that presentation we're still uncomfortable, we would make a motion at that time.

The Vice-Chair (Ms. Elinor Caplan): In fact, one of the things we can ask research to do, and I think it would be appropriate, is there have been a number of presenters who on the record—we have record of it in Hansard—have made similar, or if not similar, certainly very serious allegations and questions that I think the committee will want answered. So we can ask for all that to be pulled together and take some time at the committee at a future meeting, and we will put that on the agenda. I'll suggest that to the chair.

Mr. Elley, did you want to comment?

Mr. Reed Elley (Nanaimo—Cowichan, Ref.): Yes, I'd like to comment on that, Madam Chair.

We have two days next week where I believe we really are going to be sitting down and talking about future direction on this and pooling our ideas and our reactions to what has been said. I would think at that point would be the opportunity for us to come up with anything, as you suggested, Carolyn, that we could do on this subject, and that we'll pursue it very vigorously next week when we meet together as a full committee.

Ms. Carolyn Bennett: I'm just disappointed that I will be travelling with the custody and access committee. I'm sure my colleagues will know my feelings on this.

I think it's one thing to write the law or to actually have input in regulations and those sorts of things. It's another thing to feel that the implementation of that is possible in a climate or a culture of administration. And I think that's what we're feeling, that as a committee we have a responsibility that whatever we do happens and does protect the public interest.

I must say that I think there's also this cloud around, such that it skews us to when the first presentation happens, that I think there's a feeling that a third category would be a good idea because it would be an opportunity to hire a bunch of new people who know what they're talking about, and at least that part would be protected, or a sort of pure area within this other stuff that needs some work, it sounds like.

As you know, at the first day of the hearings I asked, if all of these advisory committees and all of these things are working perfectly and this kind of consultation, how did we get to the position that garlic would be a criminal offence, or wherever we started? So I have some discomfort.

My only other question would be about the food. I was surprised to hear that you thought Canada was a leader in food labelling, because certainly that's not the cards and letters and information coming to my office. I would like to know, as representatives of the industry, couldn't you just do it, or do you have to wait for the government to tell you to do it, in terms of what's the right thing to do in protecting the Canadian public in terms of what's in a food?

I don't think that's as good as it could be, and if you indeed say it's a continuum, then you're going to have to tidy up this side in what has gluten or peanut oil, and the kinds of things about which I guess some of the people with very special needs are concerned, that Canadian products aren't as tight as the rest in terms of labelling.

Ms. Laurie Curry: Well, with respect to Canada's leadership role and the comments that I made, Canada has been a leader for a long time in terms of establishing the criteria around particularly claims, whether they be nutrient content claims, which describe things like saturated fat, fat, sugar, and that type of thing. That's where Canada has done that leadership role, with respect to what the scientific criteria are around how you establish a claim.

With respect to the industry, all that is laid out, either in the regulations or in Canada's guide to food labelling and advertising. So this really is the Bible to the industry. This is produced by the Canadian Food Inspection Agency; this is the enforcement around all the guidelines and labelling criteria in Canada. So this is what the industry must adhere to with respect to its labelling and packaging. Today, as a matter of fact, Health Canada is initiating a one-day session looking at nutritional labelling.

There are different elements of a label. There's the ingredient listing; there are things around “may contain peanuts”, for example. There are the nutrition components to the label. And in fact with respect to nutrition labelling in Canada, that right now is undergoing discussion, because Canada is in sync with the rest of the world and with Codex on its nutrition labels.

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The U.S. has done something different. We, however, being the food industry, are in a major trading situation whereby 80% of the products we produce in terms of export go to the U.S. Also, Canadians are pretty much North American consumers. We have to take a look at what from a labelling perspective makes sense for Canadians as well as what makes sense from a labelling perspective with respect to the nutrition context in Canada. Some of our dietary guidelines in Canada may not be exactly the same dietary guidelines as in the U.S. Labelling ultimately is an end-product of what the guidelines and the criteria are.

Ms. Carolyn Bennett: In terms of your clear recommendations that there not be a third category, that it could all be handled under food, I feel as a practitioner that if somebody goes to a store and buys a bottle or goes to the homeopath and gets something that actually may have arsenic or strychnine in it, that somehow as just a lay public person I don't think they see that as food. I don't believe they think that as soon as somebody bottles it, puts it in a capsule, and puts a label on it.... I think they have a different set of expectations of us as government to actually make sure what they're getting. I don't think they care quite as much about....

I think in your bran example I know exactly where I'd draw the line: it's at one and two are there and then if I were going to put bran in three I would say I would expect them to say that they had to have a certain amount of water with it. There would be a whole different bunch of things I would say if it were a therapeutic value rather than a preventive value, or it's a good thing to take bran every day cause Dr. Burke had said we wouldn't get cold again. It would be a whole different set of guidelines. I think that in the continuum some of us would have some clear indications as to where we'd draw the line.

Dr. Richard Black: We're not saying that it should all be food. We should be clear on that. What we're saying is that there are some products with inherently very low risk, either because they are self-limiting in the intake or there are very few side-effects, and so and so forth. Those should be looked at and they may be in the form of a food. They should not be prohibited from carrying a health claim. They should be regulated as foods, depending upon the risk. And the risk has been outlined: it's not only how safe and effective is the product itself, but what are the claims it's proposing to make.

Ms. Carolyn Bennett: But the homeopathic things you would put over in drug?

Dr. Richard Black: No. It depends upon the risk. And I'm not a homeopath; I'm in the food industry. I don't want to say that we have a separate standard for food that you should have for something else. That's not it. It has to be a level playing field. If—

The Vice-Chair (Ms. Elinor Caplan): I've been very lenient on time because I don't have a long list of speakers, but Ms. Wasylycia-Leis says that she'd like to speak, given the rotation. I want to know what is the wish of the committee as far as leniency is concerned. Ms. Bennett now has had as much time as Ms. Wasylycia-Leis did. Did you have a question, Dr. Hill?

Mr. Grant Hill: I do still have some more. The issue of fortified food is part of this continuum, I believe, and I think Canada is behind in that area. I think we're somehow reticent to move towards fortified fruit juices. Do you think this is a regulatory thing? Please make a comment.

Dr. Richard Black: I sit on the expert advisory panel to the Health Protection Branch for functional foods and nutriceuticals. I am also on the expert advisory panel to HPB for nutriment enrichment of foods.

HPB has acknowledged in an open letter that the current regulations are too restrictive, that science has advanced, that we need to re-evaluate this and move ahead concerning issues not just addressing public health issues such as iodine in salt, vitamin B in milk for rickets, and things like that, but actually optimizing health. So they have that view now. We'd like to see them move perhaps a little more quickly than they have, and we're pushing in that direction. There's a workshop tomorrow to begin the process on nutrient enrichment. I think they acknowledge the need. I think industry has been very vocal in this, as have been many consumer activist groups.

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Ms. Laurie Curry: Remember that there are two components that you might add. Can you add the vitamins and minerals to the food products themselves through the fortification, which is the nutrient enrichment side of things?

For example, just last year, there's now the mandatory enrichment of flour with folic acid. I heard Dr. Bennett mention it. But the difference is that in Canada we can't talk about that, so we can't then make the connection for the consumer to say that folic acid is in flour for this particular reason: spina bifida. You can't make the link for the consumer. In the United States, because they allow health claims, you can make the link.

So there are two aspects here. Can you add vitamins and minerals to food products to begin with? Canada has a very restrictive implementation policy around that. It's pretty restrictive: the answer is basically no.

That's why these kind of combine. That's why we're really here today. As you start to fortify foods, you're going to want to be able to tell consumers about them. And right now, because of the current labelling of food and the definition of a food and a drug, we can't talk about it. We're not able to provide that link to the consumer.

The Vice-Chair (Ms. Elinor Caplan): On behalf of the committee, I'm going to ask you to table the open letter to which you just referred. That's the one you said was from the department. Also, can you leave your book of standards? If not, we'll get it if you tell us where.

Ms. Laurie Curry: I had to buy this one.

The Vice-Chair (Ms. Elinor Caplan): In that case, if you'll let the researchers know where you got it, we'll make sure that we have it available for the committee as well.

We're very short on time. A very short one.

Dr. Michèle Brill-Edwards: One very quick comment.

This issue that we just discussed about folic acid and the fortification of foods with folic acid is very instructive for the committee. There's work demonstrating the value of folic acid in preventing what we call neural tube defects, which involve very severe deformities in children. It causes them not to have a full spinal cord, which paralyses them for their lives.

The work showing that neural tube defect incidence drops when people have adequate folic acid in their nutrition was to a great extent done in this country. The Hospital for Sick Children staff were beside themselves because they could not persuade Canadian food authorities of the public health importance of this new information. Meanwhile, the U.S. was moving ahead and going toward fortification.

I wanted to just point it out because it's such a good example of the culture of a department that sees its own existence as the raison d'être and does not see that the whole reason we have a Food and Drugs Act is to make the health of Canadians better. We shouldn't be using laws to actually preclude sensible measures that will benefit Canadians, and where the laws do preclude those sensible measures they need to be re-examined and adjusted.

[Translation]

The Vice-Chair (Ms. Elinor Caplan): Ms. Picard, could you please ask your questions?

[English]

Also, Judy, put your question, and then we'll let the guests answer both questions.

[Translation]

Ms. Pauline Picard: Just a moment, Madam Chair. I think I'm a bit confused. I thought everything was clear, but every time we hear witnesses, some elements are added. It's quite complex.

Dr. Black, you say there are low-risk and high-risk natural products. Laboratories determined whether a product is low- or high-risk. Who decides? Apparently, we don't have the expertise nor the resource persons with the necessary knowledge to assess whether a natural product is low- or high-risk. Who actually decides? Sometimes, we want a product fortified. You were talking about food enrichment with calcium, vitamins and so on. Who decides that such a product is approved or not?

Dr. Richard Black: Would you allow me to answer in English?

Ms. Pauline Picard: Yes.

[English]

Dr. Richard Black: I think there is expertise in Canada and internationally to look at any particular herb, botanical, food, or drug that might be under consideration.

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I cannot speak to the drug or the therapeutic products directorate program specifically, as I'm not in that field. My experience with them has been that they have been a very qualified group, but I do not have specific examples of problems one way or the other.

I think that there exists currently an organization that, if properly staffed by scientists from a broad spectrum of specialities, will be able to make these decisions.

Ms. Judy Wasylycia-Leis: That last comment is a very important one. We have heard time and time again that the department may in fact lack not only good sense, but good, qualified scientists. So I think that has to be part of all of this.

My question is to Michèle Brill-Edwards. I would like her to give some clarification to this committee as we talk next week about how we can get to the bottom of these allegations she and others have made. I'm a bit worried that, despite the best intentions of this committee, word will come down from wherever that we should not worry, as this will be studied by the scientific advisory panel appointed by the minister around the question of the moratorium on the food research labs.

By the way, committee members should know that the six-month period for the labs is officially up today. I'm worried about the future of the food research labs. More important, I'm worried about that becoming the excuse for not pursuing a further inquiry.

The Vice-Chair (Ms. Elinor Caplan): Please put your question.

Ms. Judy Wasylycia-Leis: I would like Michèle Brill-Edwards to flesh out her idea of an independent inquiry and what we need to do as a committee around that.

Dr. Michèle Brill-Edwards: There are many forms that a public independent investigation can take. Having given this some thought, we recommend that the committee bring about an audit inquiry. This is a form of inquiry in which independently appointed individuals set out the criteria by which it would be reasonable for the department to perform its duties to protect the public under the Food and Drugs Act and then independently gather evidence to determine whether or not those performance standards were met.

The Vice-Chair (Ms. Elinor Caplan): What I would like to suggest is that if there are any particulars you would like to put down in writing along with the brief that you are going to present to the committee, if you could get it to the clerk by Monday, he will have it available so we can have a further discussion. It might be helpful, since this is a difficult and important question for the committee, to have your thoughts in writing so we can look at what some of the different options might be.

Dr. Michèle Brill-Edwards: Just to inform you, the briefing presented this morning does have a brief description at the very end in the recommendations. We would be happy to amplify that.

The Vice-Chair (Ms. Elinor Caplan): If you want to amplify it, we would be happy to receive it.

Just before I adjourn the committee—we have two minutes—I wanted to see if I heard you correctly in the food association. While you are saying that you do not want a third category, I clearly heard that you do want an alternative process for evaluating foods that make claims. Is that a fair assessment of what you have said? What exists today is not good enough?

Dr. Richard Black: Yes. What exists process-wise.

The Vice-Chair (Ms. Elinor Caplan): Thank you very much.

Ms. Judy Wasylycia-Leis: On a point of order.

The Vice-Chair (Ms. Elinor Caplan): I don't think it's a point of order.

Ms. Judy Wasylycia-Leis: It is a point of order.

The Vice-Chair (Ms. Elinor Caplan): Is it a real point of order?

Ms. Judy Wasylycia-Leis: Absolutely. It's pursuant to a document this committee has requested that I do not believe we have received. This is the commitment by the officials from the therapeutic products branch to provide us with this peer assessment review of the reasons behind the closure of the Bureau of Drug Research.

The Vice-Chair (Ms. Elinor Caplan): It's not a point of order, it's request.

I would like to thank you all for attending this morning.

The meeting is adjourned.