HEAL Committee Meeting

STANDING COMMITTEE ON HEALTH

COMITÉ PERMANENT DE LA SANTÉ

EVIDENCE

[Recorded by Electronic Apparatus]

Monday, April 27, 1998

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[Translation]

The Chair (Ms. Beth Phinney (Hamilton Mountain, Lib.)): Good morning, everyone.

This is the 37th hearing of the Standing Committee on Health. It is with great pleasure that we are in Montreal today to continue our examination of regulations concerning natural health products.

[English]

Our study covers a wide range of natural health products—vitamins and mineral supplements, homeopathic preparations, and herbal remedies, herbal remedies including North American, Chinese, and ayurvedic products.

[Translation]

Our public hearings began last December. Since February, we've held five meetings a week in Ottawa, videoconferences from Halifax, Calgary and Winnipeg, and we also held public hearings in Vancouver and Toronto.

[English]

We've heard from a variety of witnesses—representatives from consumers, manufacturers, retailers, distributors, as well as health care practitioners. Although many shared similar views, still many others expressed conflicting opinions.

[Translation]

Since many witnesses are to appear before us today, I would ask you to respect the time limit set for you. Thank you.

Our first witnesses today are Arlette Rouleau, President of l'Institut de pharmacopée chinoise, as well as Luc Martineau, its Vice-President. I think you have 15 minutes, including the question period.

The Clerk of the Committee: Half an hour.

The Chair: It is indeed half an hour. I apologize.

The Clerk: We're a bit late.

The Chair: Yes, but I will still give them half an hour. We have two members of Parliament here today: Elinor Caplan, who is Vice-Chair of the Committee, and Pauline Picard. Which riding do you represent, Ms. Picard?

Ms. Pauline Picard (Drummond, BQ): I represent the riding of Drummond and I'm a member of the Bloc Québécois.

The Chair: Very good.

Ms. Pauline Picard: I'm also the health critic for my party.

The Chair: I think Joseph Volpe will also be here from Toronto, but he hasn't arrived yet. Arlette, you have the floor.

Ms. Arlette Rouleau (President, Institut de pharmacopée chinoise): Good morning. On behalf of l'Institut de pharmacopée chinoise, we would first like thank the Standing Committee on Health for welcoming us and giving us this opportunity to offer our views on Chinese pharmacopoeia and its application.

The Institut de pharmacopée chinoise is a non-profit and charitable organization that works to develop the Chinese pharmacopoeia and to improve public health. The institute was founded in 1991 and includes professional acupuncturists and therapists as well as members of the public. The institute also promotes the recognition and use of the Chinese Materia Medica in its research, education, prevention and disease treatment activities using products in the Chinese pharmacopoeia in the spirit and respect of traditional Chinese medicine.

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The ultimate objective underlying these various activities is the quality of the products and protecting the public. We believe that the use of the products in the Chinese pharmacopoeia can be safe and can represent an effective and economic alternative to traditional western medicine as well as a complementary form of medicine. It is not necessarily an alternative medicine. These are two forms of medicine that can work and should work together.

The Institute believes that the objective of safe and effective use of these products requires that three fundamental conditions be met: first of all, the recognition of traditional knowledge; secondly, the creation of a third category, namely natural health products; and thirdly, quality control for these products.

The first thing that must be explained is that it is important to remember not to confuse Chinese medicines and products in the Chinese pharmacopoeia. The products in the Chinese pharmacopoeia include vegetable substances, fruits, leaves, flowers, roots and rhizomes, and animal and mineral substances recognized for their therapeutic effects.

Some may be surprised to find in this Materia Medica minerals or other elements of animal origin. While the expression "herbs" generally involves things that grow in nature, when one refers to Chinese herbs, this of course includes medicinal plants but also mineral or animal substances. Chinese medicines refers to medications used in western medicine that are manufactured in Asia. They may sometimes contain mixtures of plants to which chemical ingredients have been added.

Popular usage often confuses those two expressions, and we want to remind you that the genuine Chinese pharmacopoeia remains the one that is based on a refined knowledge of medicinal plants and mineral or animal substances, either singly or in combination with vegetable products.

Mr. Luc Martineau (Vice-President, Institut de pharmacopée chinoise): We have here six exceptional documents, in French and in English, which contain the compendium of the products included in the Chinese pharmacopoeia. These documents are available for those who wish to examine them. At the end, there are references for those who wish to buy these products.

When speaking of the Chinese pharmacopoeia, it is essential to have on hand the tools that already exist and that serve as world authorities on the subject.

Ms. Arlette Rouleau: Allow us to open a second parenthesis before broaching the three conditions we cited earlier. There are major differences in philosophy underlying the Western and Oriental medical systems, and the understanding of therapeutical approaches used in either system.

Earlier, we underscored the possible confusion regarding the term "herbs" which has different connotations. We share the views of Mr. Joseph Wen-Teng Wu, who maintained in his presentation on November 29 of last year the need to include vegetable, mineral and animal substances in the expression "herbal compounds" when referring to traditional Chinese herbal medicine and to preserve its integrity without perverting it.

The major difference undoubtedly resides in the fundamental concepts of the two medical systems. In the West, the scientific view of the human body fragments it into systems, into sections that have more or less importance, and the interventions that can be done on the section or sections affected by disease. In the West, importance is placed first and foremost on repairing what is broken or restoring the function of the organ or system in question.

In traditional or Chinese medicine and pharmacopoeia, the cornerstone is the theory of yin and yang, and the five elements: water, fire, wood, metal and earth. The balance between yin and yang and harmony between the exchange of energy of these five elements constitute the basis of all concepts and of the entire terminology of this medicine. In the East, the point is to restore balance, to preserve energy, and to tone the entire body in a truly holistic manner.

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Attempting to regulate a medical system that is Oriental and totally different, based on the premises of another system appears to us to be contradictory. Indeed, we feel it would be quite problematic to impose biomedical or pharmaceutical standards based on Western medical theory when the concepts and paradigms of Oriental medicine are different. The point is not to denigrate one system to the detriment of the other. We believe that the point is to have the lucidity and courage to recognize the merits and capacities of another therapeutic approach and to find an acceptable level of analysis to explore what both of these systems may have in common.

Let us close these parentheses and get back to the initial conditions for achieving the objectives of a liberal, effective and safe usage of the Chinese pharmacopoeia.

The first condition is the recognition of traditional knowledge. The Chinese Materia Medica is the most advanced source of knowledge on vegetable, animal and animal substances recognized for their therapeutic properties. In 2700 B.C., China already had a list of 365 medicinal substances with their therapeutic properties. Today, some 5,767 products, of which 90% are of vegetable origin, are inventoried and examined in the Zhon Yao Zidian, an encyclopaedia published in 1977 by the Shanghai People's Press. We know that no fewer than 400 of these products are used regularly. We also know that 3,800 different remedies are prepared in Asia and that in the vast majority of cases, they issue from a manuscript written two centuries after the birth of Christ, the Shan Han Lun, a treatise of liver-related diseases. Continuous and effective application over more than two millennia of these therapeutic substances constitutes, in our opinion, sufficient evidence of the safety of their use. If this wasn't the case, no survivor could have transmitted this knowledge.

The science of Chinese herb products therefore developed through written works, the direct transmission of knowledge and in vivo clinical results. Current use of the pharmacopoeia is still based on the extensive experimentation of herbs conducted in ancient China and on appropriate plant mixtures. we also take into account the paradigms pertaining to the balance of yin and yang as well as the energy flow between the five elements. While this approach may seem disconcerting or illogical for Western medicine and pharmacology, the fact remains that the results today are convincing and that Chinese pharmacopoeia keeps people in good health.

In a nutshell, it works, and we can explain why. Moreover, in the appendix, we have included a table pertaining to two well-known plants, mint and cinnamon, and the properties of each of these plants when used according to the principles of Chinese pharmacopoeia. I won't read it, because it has been included at the end of the appendix. This table will give you an idea of what we mean by traditional plant knowledge. This is a concrete example that pertains to two plants that everyone is familiar with, cinnamon and mint.

Mr. Luc Martineau: These appendices come from a reference book entitled Materia Medica by Dan Bensky, which was recently revised and is the current authority. This book summarizes the 400 most commonly used products of Chinese pharmacopoeia, including their pharmacodynamics.

Ms. Arlette Rouleau: The Institute feels that the tradition of using Chinese pharmacopoeia depends as well on the skill and professionalism of those who use it in their regular practice. This is why the Institute feels that an acupuncturist, or herbalist, etc., who is experienced and who has had rigorous professional training in Chinese pharmacopoeia can treat clients effectively and safely.

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I would like to talk about an issue that has not been included in the brief. It is clear that occupational training currently comes under provincial rather than federal jurisdiction. However, if we want to think about a good management system for plants, we're going to have to consider the fact that we need competent people to treat and counsel people with physical health problems.

Second condition: the creation of a third category, natural health products. At present, the Food and Drug Act has two categories: one for food and one for drugs. Where do medicinal plants fit in?

Indeed, we have the food group, which includes substances used to nourish, which must not have the following characteristics, a food must not be used to treat, diminish or prevent an illness or a physical disorder in animals and human beings; a food must not be used to restore, correct or modify the organic functions of animals or human beings.

I believe that the Act was very accurate in 1950, when it was thought that foods consisted of carbohydrates, proteins and lipids. Today, however, we are aware that nutrition plays a very important role in maintaining good health. This is even truer for medicinal plants, which are sometimes foods, but which have some very important properties for maintaining good health.

Secondly, if we examine the second category, namely, patented drugs sold over the counter or by prescription, we can see that they are all subject to a series of tests and must be approved by Health Canada before they can be sold on the market.

Medicinal plants do not correspond to the definition of a food. It wouldn't be logical since its objective is to maintain good health. Moreover, we can't patent a medicinal plant because plants are part of the global genetic legacy. So, how can we use, in order to analyze plants, criteria used for drugs or foods? This ambiguity poses all kinds of problems for herbalists, manufacturers and distributors of medicinal plants.

The Institut de pharmacopée chinoise proposes the creation of a third category, a category of natural health products. By creating this third category, we will remove all of the ambiguities and promote more effective use of Chinese pharmacopoeia.

Moreover, an agency that is at arms' length from the Therapeutic Products Directorate must be given responsibility for the natural health production regulatory framework. An independent agency is what is needed to recognize the special nature of natural health products. The TPD's interest in natural health products has been slight, focussing on the potential risks associated with their use rather than therapeutic benefits.

Also, it would appear that the level of knowledge of the current regulatory authority is not adequate to ensure that there is a judicious approval process for natural health products sold in Canada. A separate entity could operate effectively in accordance with principles that are acceptable to both industry and government. The Institut de pharmacopée chinoise is also of the opinion that this autonomous agency should be able to rely on a standing committee of experts with a mandate to specify the content of the pharmacopoeia.

It is understood that the experts the Institute would like to see as members of the organization will be individuals who are recognized for their knowledge and expertise in Chinese pharmacopoeia because, at present, the experts who are generally consulted in health matters, namely, doctors, chemists and pharmacists, have no or little knowledge of natural health products and their healing effects.

Since this would be a third category that excludes foods and drugs, we think it makes sense that only those individuals who are qualified, competent and independent be called upon to judge the value and quality of natural health products.

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Third condition: quality control. It is imperative that Chinese pharmacopoeia products sold on the market comply with quality standards and that the plants that come into the country be subject to rigorous monitoring. The Institute agrees with a proposal made by Mr. Joseph Wen-Teng Wu that specialists in traditional Chinese medicine be tasked with drafting the quality and approval standards for these products.

This recommendation is in keeping with the acknowledgment that there are fundamental differences between the two medical systems. The Institute would also remind the committee that Chinese herbalists already have a quality control system which was established a long time ago and which sets out the quality standards according to product category.

When Health Canada feels that a Chinese herb product has caused a serious accident or significant side effects, we feel that it is its duty to investigate more carefully all possible causes for the incident: which individual provided the treatment; for which problem; nature, duration, combination with other pathologies if applicable; age and condition of the person receiving the treatment; which type of product was used and how it was to be taken. In summary, a rigorous investigation should be conducted to determine all of the factors that could have led to the accident or side effects before coming to the conclusion that the plants of Chinese pharmacopoeia are toxic.

Moreover, this is one of the reasons why the Institute is hoping that an expert will be present during all assessments of any Chinese herb products. The presence of such an individual, in addition to the investigation, will avoid any hasty decisions that cause considerable damage to the reputation of Chinese pharmacopoeia.

We all know that patented drugs used by consumers, drugs that are available over the counter or by prescription, can cause side effects, in varying degrees, and that such occurrences are not publicized to the same extent as those problems associated with the use of medicinal plants.

As an example, we have only to look at a recent article published in the newspaper Le Soleil on April 15, 1998, quoting the results of 39 studies conducted in the United States to appear in the Journal of the American Medical Association dealing with the side effects of conventional drugs. Every year, some 2216 million Americans in hospital are the victims of drug side effects, and pharmaceuticals cause the deaths of 106,000 people. They are the fourth biggest cause of death in the United States.

Although researchers do acknowledge the limitations of the studies, such as the increased use of medication to offset shorter hospital stays, for instance, the fact remains that it is worth thinking about the situation and conventional drugs are not as safe as we are led to believe.

Quality control also implies certain labelling standards for natural health products. Each product should indicate clearly and precisely the name of the product, both the common and scientific name, the parts of the plants used, the source of the product and information about the producer. In addition, specific recommendations with respect to the dosage should also be included on each product, as well as the side effects and potential dangers for certain clients: pregnant or nursing women, young children, elderly people or those afflicted with certain diseases.

Finally, every label should be clear about the usefulness of the particular product. Consumers need complete information, regardless of what the product is. Accordingly, reports must present the truth without any bias, misconception or deceit and they must not contain any defamatory information. In other words, consumers must be informed about the beneficial effects of natural health products and not only their side effects.

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Wanting to protect the public by providing it with information that is incomplete and at times partial is just as harmful as wanting to hide from it all the truths about the properties of Chinese pharmacopoeia plants. The practice of using Chinese herbal products has proven itself in the country and deserves to be given the respect and the place to which it is entitled. Thank you.

The Chair: Thank you very much. Unfortunately, we have time for only one question per member. I hope that the briefs that follow will be shorter because the members are really interested in asking you questions.

Ms. Caplan.

[English]

Ms. Elinor Caplan (Thornhill, Lib.): I would just ask that you table a bibliography, a list of the books that you've presented for the committee so we'll have that as part of the record. I'm sorry there's no time for questions.

[Translation]

The Chair: Ms. Picard, a question followed by a brief answer, please.

Ms. Pauline Picard: What are your biggest difficulties right now? You are asking that we create, a third category; you are also asking that we set up a regulatory framework and an independent agency. It seems to me that you are experiencing difficulties because the experts or people regulating Chinese products do not have enough knowledge.

[English]

Mr. Luc Martineau: For Mrs. Caplan, we would just like to explain that the Chinese Materia Medica...we will list these publications for the committee.

[Translation]

Ms. Picard, first of all, it is important to recognize that there is a body of knowledge that experts often ignore. This is the reality. Ginseng Panax quinquefolia grows right here in your region, and people don't even know what it's used for. There is some kind of a block and we don't want to recognize this body of knowledge. Our Institute would like to promote this body of knowledge and ensure that these products are used in a completely safe manner.

Ms. Arlette Rouleau: We are also experiencing difficulties because of a frequent tendency to pass judgment on our products. For example, a decision will be made about ephedra, a medicinal plant, based on knowledge of ephedrine, which is one of the active ingredients of this plant. Consequently, people are confusing the active ingredients and the analyses done on the plant. Many side effects accompany the use of ephedrine, although this substance is currently sold over the counter in drug stores under the name of Sudafed. The plan known as ephedra contains only 2 per cent of ephedrine and it has many other active ingredients, but the side effects listed for this product are those associated with ephedrine. I recommend ephedra to my patients and I've never observed the same side effects, because the plant doesn't produce the same effects as the isolated active ingredients. We far too often pass judgment on these plants based on such criteria rather than their overall characteristics.

For example, when you ask for a DIN for any product that stimulates...

The Chair: Ms. Rouleau, there are other witnesses waiting so if you could possibly give a brief answer.

Ms. Arlette Rouleau: I simply wanted to explain the matter of DIN and traditional learning because it's very important. For example, Xiaoyao San stimulates the kidney yin, nourishes the blood and is very good for premenstrual and digestion problems. But if there's a yin problem with the liver and you have to nourish the blood, that product is not recommended. So what basis could we use to ask for a DIN and on what basis could the Therapeutic Products Directorate authorize us to request a DIN? Based on the fact that it stimulates the liver, that it frees up the liver's energy or that it nourishes your blood? Will those criteria be accepted? That's the question. If you can only use treatment of premenstrual syndrome when you're asking for a DIN, that's not fair because the premenstrual syndrome is not necessarily due to a knotting up of the liver's Qi so you can't test the product. On what basis could we have our products recognized?

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Mr. Luc Martineau: We thank you for your attention. I'll be back this afternoon.

[English]

The Chair: Mr. Chuck Roberts is the president of Immunotech Research Limited.

You have 20 minutes, but as I asked a minute ago, could you keep your comments to less than that so we have some time for questioning? And could you introduce your companion?

Mr. Chuck Roberts (President, Immunotech Research Limited): Yes. This is Dr. Bounous, one of my colleagues.

Ladies, I'll be very brief to start off, because I think we'd probably like the questions more than anything.

We're a research company that has been around for about 20 years in its research mode. We basically have a Canadian invention. I guess the word “invention” is a little hard. It's a Canadian finding. This was found by Dr. Bounous through McGill and Montreal General Hospital over the last, I guess, 20 years now. It's basically a milk protein isolate, which is an extract from milk.

We've been trying to bring this through some clinical studies for many years. Our frustration is where we stand with this. We do have a Canadian patent, four American patents, and a worldwide patent. We sell this product throughout the United States and Europe, through a lot of doctors, clinics, and cancer clinics.

Our frustration with the Canadian market is exactly what I'm sure you've heard all the way along: we're sitting in never-never land here with the product. Years and years ago, Dr. Bounous and his doctor colleagues tried to get a DIN number. We were refused because we're a food. So we end up back as a food, but we're actually probably a medical food.

We deal with the immune system. We prove what we say. Our patents are method patents. It's a little different from taking a patent for the formulation. This is for the method, for what it does. We do carry four U.S. patents, including AIDS patents. We've just been issued a patent that's been pending for four years, because they're worldwide patents, for cancer. It has started in Australia and will work its way down to the United States. We have patents for our method of raising the immune system of a human.

We market this product in other countries. For instance, Fresenius AG, which is one of the largest European pharmaceutical companies, has a licence of ours in Europe. They market this in the traditional way, through pharmacies. Their health care system does pick up the cost of this. In the United States, we do market this through the food supplement division. We've requested to try to go to nutraceutical. This is marketed also through a lot of medical doctors, and we think in about two or three months, medicaid will pick up part of the cost of this for AIDS and some of the people in the United States.

Coming back to Canada, we are a Canadian company. We employ folks here in Vaudreuil. We do sell this product as a food product in Canada. We're not even allowed to use our own name. We're not allowed to show anybody the patents—they are Canadian patents—because of the food regulations, which we do understand.

We do clinical studies. For instance, we're doing a double-blind study, a phase three study, at the Montreal Chest Institute with Dr. Lalonde. It has been going on for quite a while. We're just going to break the code shortly for AIDS. We're not allowed to tell anybody we're doing that, and this is costing the Canadian HIV network probably a couple of million dollars, a small fortune. We're putting a lot of money into this.

We're doing another study at McGill, through the Children's Hospital and Dr. Larry Lands, on cystic fibrosis.

These are serious clinical trials that we are paying for, but we can't tell anybody we're doing this. We're in a frustrating area, where we're going here. So we really need some sort of middle category to stay within this market here.

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Now, I'm from here, and I'm determined to stick out what we're doing in Canada here, because this is our head office and we're going to make many, many millions of dollars in exporting this product. This is a dairy product. We work with the local dairies. They're not up to the technology that we have yet, but we are working with them. We do bring the product here. We do all the packaging through the pharmaceutical plants in Quebec City and in the east end of Montreal.

We are going forward with our method of selling it, but as I say, it has been very frustrating. We are going by the rules in Canada, but it kind of holds back what the public should know about what we're spending. It's real. For instance, in the American market—I'm not using that as a criterion, because I don't think it's 100% the way to go—we're allowed to show people what we have as long as we can prove it.

These come from clinical studies done by doctors. Look at how Dr. Bounous's career has gone. I've given you folks some small brochures. A lot of the brochures are not translated because we're not allowed to translate this into French yet, because that's not allowed by the rules here. So we brought you some of the American things we have. I put in Dr. Bounous's CV. There's a clinical foundation there that was written by the doctors. That's real. Other doctors use it to deal with this thing.

I think the main thing that we have here.... I'll go back to this. It's an invention that was done in Montreal. We've got something really unique in its category. It's basically mother's milk for adults. This is what they've created. They've got a way to extract this particular whey protein and isolate it from milk and keep it together so you can get the effects form this. They've done the studies. We have the proof of what we're talking about here.

The pharmaceutical companies in the rest of the world do not take these licences on for fun. They spent millions of dollars doing this research. The European company will do something like 60 million Deutschmarks in the first year in their business over there. This is big. You're talking about a huge market share.

This is great for a little Canadian company that's coming out of nowhere. It was a small research company. We put it together and we marketed it. We licensed 20 countries in the last eight months, so these pharmaceutical companies know what they have. We would love to have this middle category put down somehow so that we could basically show what we have. I'm sure a lot of other people would do the same thing.

That's my brief thing. I'm sure that if you would like to ask some questions, we would certainly try to answer them.

The Chair: Thank you very much. Ms. Caplan.

Ms. Elinor Caplan: Yes, thank you.

[Translation]

I'll put my question in English because it's easier for me.

[English]

I'm going to ask my questions in English, and I have many.

One of the things this committee is considering is how we deal with those products that are foods, or have been traditionally categorized as foods, that want to make a health claim. I've often described them as those things that look like a drug, make a medicinal or therapeutic claim like a drug, but in fact, are not synthetic.

Your product is a natural product?

Mr. Chuck Roberts: It's from milk.

Ms. Elinor Caplan: The question I have is this: is there any risk involved with your product?

Mr. Chuck Roberts: None, if you drink milk or take protein. For instance, we've even taken the lactose out of it. A lot of this is dealt with in very extreme cases and through their clinical studies through feeding tubes and stuff, so you have to deal, especially in the AIDS community, with people who are lactose-intolerant. So there's no fat or lactose in this.

Ms. Elinor Caplan: So your product is an example of the sort of natural product that the committee is considering in terms of what we should do with it—

Mr. Chuck Roberts: Right.

Ms. Elinor Caplan: —and how, if at all, it should be regulated. One of the concerns I have is not so much with the notion of the development of a third category, but of an alternative process for regulating—I guess that's the word I would use—to ensure safety and quality.

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But for me, the real question, if you look at the mandate of this committee, is to enhance consumer access and freedom to products while ensuring quality and safety. You'll notice in that mandate that it doesn't mention efficacy. So I guess the question I would ask to begin with is: do you believe that if a product makes a health claim it should have to present evidence appropriate to the claim it's making?

Mr. Chuck Roberts: Yes, absolutely.

Ms. Elinor Caplan: And if we have an alternative method of regulating those products that traditionally have been viewed as food that would fall under the food part of the Food and Drugs Act, but they wish to make therapeutic claims, do you believe it's the responsibility of Health Canada, as the regulator, to assure the quality of the product as in GMP standards?

Dr. Gustavo Bounous (Medical Director, Immunotec Research Ltd.): Yes.

Ms. Elinor Caplan: Would this also be the case for the safety of the product and, in other words, that what the product says it is, that's so?

Mr. Chuck Roberts: Yes, absolutely.

Ms. Elinor Caplan: Would you favour a method that would allow for a disclaimer so that you didn't have to get into all of the kinds of trials and research that in fact you're getting into?

One of the concerns is that many of these products are in pharmacopoeia, and evidence has been presented on other products that says there are thousands of years of history and monographs and so forth, but they're not the traditional, double-blind research trials, which as you said, are so expensive. Could you see a place for a disclaimer that would allow for a natural product that hasn't done all of the research, or do you believe it should all have the same kind of research?

Dr. Gustavo Bounous: I would like to first mention what a natural product is. It's an overused term. Most of the poisons are natural products, such as arsenic, cyanide, etc. So it's natural in the sense that it comes from a natural source and doesn't contain additives. What I would like to see personally is a verification of the claims in a university setting. That can be done probably in the same way as for drugs.

Now, as Mr. Roberts said, we face two trials that are going on in Montreal and at U.S. universities. We are waiting for the results. Some are already forthcoming. But certainly, only an independent verification by qualified clinicians will give us that.

Now, what the government would do with this is a different question. The definition of food is that it's a material that provides for physiological structure, function, and growth. It doesn't make a claim. The definition of a drug is that it's a material that provides a benefit to health and does not include food. It's easier to define drugs than it is to define a medical food.

My definition of a medical food, if I may, is that it's a food that, in addition to and independent of nutrition, provides some benefit to the treatment or prevention of diseases.

Ms. Elinor Caplan: But what about the use of a therapeutic product, as opposed to food, if it's a therapeutic product or a natural therapeutic product?

Mr. Chuck Roberts: But if you're looking at the definition in terms of where we market this product, it does help a lot of people who are sick, obviously. It's obviously for prevention, which is probably the biggest part of your market if you are a company trying to do business here.

Ms. Elinor Caplan: One of the concerns of this committee that I'd ask you to address is the fact that there are many products that have been traditionally used for many, many years that don't undergo the kind of processing that your product undergoes. Also, they have a history of use internationally or among different cultures. So if you were to subject these products to the rigours of research, it would make them prohibitively expensive for consumers.

A voice: Could be.

Ms. Elinor Caplan: That's a concern they have. Would you like to address that concern?

Dr. Gustavo Bounous: I understand that. On the other hand, I think the ultimate decision will be made by science and the scientific method.

What our company is saying and what we're demonstrating in animal experiments will be verified by independent clinicians. If so, if the results are positive, then we ought to be able to claim that.

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Ms. Elinor Caplan: The question I have is, could you see an alternative process for regulating products that would give you the freedom, if you wished, to do the trials or that would also allow for the more traditional use and the compendium—

Mr. Chuck Roberts: Yes.

Ms. Elinor Caplan: —that would allow for a disclaimer if they didn't have all the trials and research?

Mr. Chuck Roberts: I think you're on the right track. Nobody wants to spend all this money on things, but we're still sitting in the middle of nowhere because of the fact that we have done the trials, and we have done this over many years.

We're dealing with the medical profession, and they do things in a different way. Everybody has to make sure they agree with everything else, and it all has to go through its due process. Dr. Bounous is no different from that.

It's a situation where I'm sure there are lots of other good products around that could fall into a category of the nature of ours, but I think we really believe there should be some proof before you go ahead and market things with claims. We would obviously like the middle category, to be able to make just a claim that we can prove. That's all.

[Translation]

The Chair: Thank you. Ms. Picard.

Ms. Pauline Picard: I'm sorry, but I don't think I quite got what was being said and I'd like some clarification. You're presenting a natural product that is sort of becoming a synthesized hormone and you want to get it approved by Health Canada as a therapeutic product. From that point on, the product is not considered as food any more, but as medication. Normally, Health Canada should examine your product, ensure its efficacity and safety and grant you the permit so you can label it as a product for therapeutic use. What is the matter with that? What hasn't worked? Did you ask for your patent on that hormone as a food?

Dr. Gustavo Bounous: Yes, as a food. One should clearly point out what falls under the definition of a drug or a food. It's a matter the Americans have been examining for at least two decades and they still haven't managed to identify where the nutritional aspect ends and the therapeutic aspect begins.

Our product is perhaps an illustration of what I'm saying. In this product, the active ingredient is the precursor of glutathione, which is the specific antioxidant of the cell. Normally, an ordinary diet will provide you with everything needed in the way of glutathione precursors. So, if an animal or an individual is dealing with the ordinary conditions of life, an ordinary diet will provide enough. But when you're dealing with a viral or bacterial infection, your lymphocytes have to produce many more antibodies and multiply. Then you need the antioxidant glutathione which is specific to the cell. This antioxidant must be reconstituted as soon as it is depleted or used up. So the supplementary addition of precursors, like the ones we find in this milk product, allows you to deal more easily with the bacterial invasion.

Ms. Pauline Picard: Fine.

Dr. Gustavo Bounous: Some products of inferior quality have the same food value, but they don't have the aspect that we call biological activity. Some proteins have the same nutritional capacity, but don't have that other property. This distinction is the next step up. It's easy for the pharmaceutical industry because it deals in molecules that have no nutritional value. Everything it does has an effect, whether it's useful or not, as long as it's properly documented.

We're faced with a mix of factors. There's an ingredient that has an activity and we're not sure that it's the only active ingredient because there's interaction between the other proteins in the milk. It's a long story, but there is, of course, a preventative therapeutic effect that's dissociated from the nutritional aspect.

I hope I answered your question.

Ms. Pauline Picard: Yes, yes.

Dr. Gustavo Bounous: It's difficult to define what it is.

• 1135

The Chair: Thank you very much.

[English]

Thank you also, Mr. Roberts, for your presentation today.

We have your documents. If there's anything else you think we should have....

Mr. Chuck Roberts: We have tons of it. You wouldn't have time to read it all, but it would be a pleasure to give that.

The only other thing I could tell you, briefly, is that we will be doing a trial, which was set up quite a while ago, with the Department of National Defence of Canada. It will be in their labs, wherever these labs are. They understand what we've had here, and we'd use it for their defence department and maybe off in some of the countries when they send the troops.

The Chair: Thank you very much.

Mr. Chuck Roberts: Thank you.

Ms. Elinor Caplan: As you're leaving...what I found interesting is this. My understanding was that for a food, if you make a health claim, it becomes a drug and you then have to go through all the processes.

Mr. Chuck Roberts: We tried. Because we're a food and there's nothing added to this, they would not let us become a drug. If we add something to it, then we'd be fine. The rule is food or drugs; there's nothing in between. We need something in between.

The Chair: Thank you very much.

Dr. Gustavo Bounous: The American solution has been to not put the claim on the label.

The Chair: Thank you.

The Eel River Bar group is next: Tim Dedam, Gordon LaBillois and Gilles Soucy.

Mr. Gordon LaBillois (Band Manager, Eel River Bar First Nation): Tim Dedam isn't here.

The Chair: Pardon, he isn't here.

Did I pronounce the name of the company correctly?

Mr. Gilles Soucy (Coordinator, Heritage Gardens, Eel River Bar First Nation): Yes, that's correct.

The Chair: Are you going to begin, Gilles?

Mr. Gilles Soucy: No, Gordon will.

The Chair: Okay, fine. It's for twenty minutes, and we would appreciate having as much time as we could for questioning. Thank you very much, Gordon.

Mr. Gordon LaBillois: On behalf of the Eel River Bar First Nation, I want to let you know we appreciate the invitation. We are somewhat honoured at being able to come in front of the standing committee to brief you on the aboriginal heritage garden project, which is going to be developed and located in Charlo, New Brunswick.

The aboriginal heritage garden project is an interpretive project that is a celebration of and a tribute to the contributions made by the aboriginal people to society at large. We're not into any commercialization on this project, but the project is a tool we are going to utilize to help rebuild a people and rebuild a nation that has lost so much along the away.

As you know, in our area, Chaleur Bay was one of the first areas that Jacques Cartier sailed into when he came to this great country, and the Micmacs were the first contact people. After about 450 years of European contact, a lot of our culture has been lost. We are utilizing this project to try to salvage and to recover some of the knowledge that our people once had in the utilization of plants for medicinal purposes and for traditional uses.

In doing the project, what's most paramount is that we are rebuilding a people, giving them back some pride and dignity in regaining the knowledge that some of our people once had and the special relationship our people had with its environment, with our mother the earth.

• 1140

In this project we're utilizing elders from Atlantic Canada who still have some knowledge; we're utilizing world-renowned botanists to help re-educate our people.

Over a short people of time the native community in Atlantic Canada has gone back to its roots. I can give you an example of people who have been healed using traditional medicines. We have a gentleman from the Restigouche Band, who is from 20 miles up-river from our community, who was terminally sick with diabetes. The doctor was giving that person three needles a day for his diabetes and he was still continuing to slip. But he was put through a medicine lodge, given some medicines made from seven barks of trees, and that person threw his needles away and is functioning very well today.

What's very important for natives also is the spiritual beliefs that go along with the utilization of medicines.

I forgot to mention that I'm a fill-in for another gentlemen who was to make this presentation, but I wanted to relate to you that in the east, and I guess all across this country, a lot of our people are going back to traditional medicines to help address their health.

That's about it for my short presentation, but I wanted to relate that the community, the people who have embarked on this process, now feel very confident. You talk about the special contributions that were made by natives to society. Even in my own experience as a native growing up and going to school in the town of Dalhousie, in the history books the only contributions that natives were ever given recognition for were the snowshoe, the canoe and some of these things. But when you go back to the history, you find out that in the first settlement in New Brunswick on St. Croix Island the natives provided medicine for the French to survive that first harsh winter.

We're very excited about this project because it's starting to give us back the health and wealth our people once had.

Thank you.

The Chair: Thank you very much.

Gilles, did you want to say anything before we go on to the question?

[Translation]

Mr. Gilles Soucy: Thank you.

[English]

Thank you.

[Translation]

Like my friend Mr. LaBillois, a Micmac himself, was mentioning, it's an honour to be here today. My role is to coordinate the development and the setting up of a native heritage garden mainly focussed on the New Brunswick Micmac and Malecite communities.

I'd like the members of the committee to be aware that we're not the only natives working on or undertaking projects like that. It is important to emphasize the role of our elders and the mandate we were given which was simply to deliver the message that nature's own pharmacy must also be well protected and well controlled. You've shown it significantly this morning by inviting us here to deliver this message.

• 1145

We're conscious of what's been going on for the last 10,000 years. We know that the fish resources enjoyed by our ancestors are on the verge of disappearing from our area. Many fishermen have already given up on their fishing activities this year. You have certainly heard about the battle or the confrontation between the natives and the New Brunswick government about the forest.

We're afraid that the medicinal plants won't be there anymore for our children. We're interested in the interpretation aspect, not the marketing one. I would urge the committee to be very vigilant and prudent with the big pharmaceutical companies to preserve this quality of life enjoyed by our ancestors and so we don't wind up like New Brunswick which will have no trees left sometime within the next ten years. Each tree in our province already bears the name of the family of a resident and our forest resources are declining just like the fish.

I hope that during your deliberations you will take into account the losses endured by our ancestors over the years. Once again, what we're delivering to the Canadian government is an appeal for caution.

Thank you.

[English]

The Chair: Thank you very much.

Madam Caplan, do you have a question?

Ms. Elinor Caplan: Thank you very much.

Rather than a question, I'd like to make a statement, if I could. We appreciate your coming, and I think I speak for everyone on the committee when I say that we do not want to interfere with the traditional and, in particular, the spiritual traditions, not only of the aboriginal people but also of the Chinese population who practise Chinese traditional medicine or those who practise and believe in ayurvedic methods for care. The concern for this committee, according to our mandate, is that products be safe and of good quality, and that we come up with recommendations for the minister that will give people freedom of choice and access to those products.

One of the things I've been thinking about—and you mentioned it when you said you're not interested in the commercial aspect and the marketing—is do you think it would be possible for us to recommend a differentiation between products that are commercially marketed, packaged and sold in retail outlets and those that are given by your traditional healers and not sold or marketed in a commercial packaging operation? Have you thought about that? These are some of the thoughts I've been having about how we could differentiate between the traditional healers and the things they might give to people, which they have as part of the tradition, as opposed to...I'm not going to use the word “manufacturing” or “processing” in terms of anything other than packaging. Once you put it in a package and put a label on it and put it in a store, then it would be treated differently perhaps from that which is given as part of a traditional healing process.

How would you respond to that idea?

Mr. Gilles Soucy: That's a very good question. That's a question we have to face and I'm glad you raised it.

In the interpretation of our garden now, we have identified over 220 plants, but we can only interpret so many.

We work in very close collaboration with the Museum of Nature in Canada and also the Smithsonian Institute in Washington. Someday, somehow, when the garden opens in the year 2000 and the visitors would like to buy some traditional medicine from the shelves and so on, we don't know how we're going to handle that. I think we should probably face it in collaboration with Health Canada at the time.

• 1150

But right now there are many people at our door asking for echinacea and these types of plants, and this is for the visitor who comes in. Some of that medicine is on the shelf now, and we buy some ourselves. The problem will be from the tourism side or the interpretation side. How will that be put on the shelf? There will be certain controls with Health Canada and the pharmacy control. That is something we'll have to face.

Ms. Elinor Caplan: The only thing I'd ask that you consider is this. You're seeing this as a problem down the road, but this committee is dealing with it today. There are many traditions that have products they would like to make claims for, and that's exactly the issue for this committee today. How do we deal with those products that are classified today as a food and cannot make a health claim but work like a drug? They have a dosage recommendation. How do we assure the quality and the safety of those products for the consumer?

What we're discussing now is what is in the public interest as far as consumer protection is concerned. What is the role for Health Canada as the regulator to make sure those products are safe and of good quality at the same time as permitting as much freedom of access to those products as possible?

Mr. Gordon LaBillois: The use of traditional medicines is a history passed down from generation to generation. There was a time when our elders were identified as the individual to pass down the medicine. I see there is a need for this, even for our own people who are utilizing these medicines. You could be doing more harm than good. I would recommend that some kind of a relationship take place with the native community to do some testing on some of the medicines that are being utilized across the country.

One of my concerns is that there are some medicines or some drugs that are being utilized in the native community that are illegal today in this country. I know that in the United States and out west somewhere they use medicines in the sweat lodge; if you were caught with them, whether it's marijuana or some other substance, you could be charged as a result of that.

I think there is a need for Health Canada to open some dialogue with the native leaders across the country. With the science and with the research that's available from Health Canada, it's long overdue, I guess.

The Chair: Thank you.

[Translation]

Ms. Picard.

Ms. Pauline Picard: What I have are actually more comments than questions.

Mr. Labillois, you were saying before that the native peoples, with their traditional medicines, nursed the first French to set foot here in Quebec. The native medical traditions were handed down and you've never withheld any of your recipes or techniques to help the community. You don't have to go very far back to hear it said in our families that "this is an old wives' cure" but our old wives' cures often came from the native community.

I have a grandmother from the lower St-Lawrence and I still use some of her techniques that were based on plants and vegetables.

• 1155

So it would be a good thing to have your wise people who still use those plants and natural products sharing this information with people so that they can use as natural an approach as possible.

I also wanted to say, Mr. Soucy, that I have made note, as has the committee also, no doubt, of your warning concerning the conservation of our flora and our natural resources. I thank you for coming here.

The Chair: Do you have anything to add? Fine, thank you.

[English]

The next group is the Association of Quebec Chinese Herbalists. Ing Dan Tran's name is the original listing, and I think she's the president. We now have several others who are also appearing at the same time. We're also going to have l'Association de médicine chinoise, so I'll ask them to let us to know who's who.

[Translation]

Ms. Ing Dan Tran (President, Association of Quebec Chinese Herbalists): The Association of Herbalists.

The Chair: The doctors on that side and the herbalists on the other? That's fine.

[English]

We'll hear from both groups first, and then we'll ask our questions afterwards.

[Translation]

First, we'll hear the Association of Quebec Chinese Herbalists. Madam.

Ms. Ing Dan Tran: Good morning.

The Chair: Good morning.

Ms. Ing Dan Tran: I am President of the Association of Quebec Chinese Herbalists. First, I'd like to clarify one point. We are two different groups. If, after my presentation, you have any questions, I'd like you to address them to the members of our association. Thank you.

Today, we will speak about the toxicity of Chinese medicinal plants and on the reasonable manner of regulating these plants. You have already heard about the toxicity of Chinese medicinal plants. I believe that this is a very important question and I would like you to pay specific attention to it before drawing up regulations concerning them.

During the past years, in newspapers and in television broadcasts, several reports were broadcast regarding the toxicity of Chinese medicinal plants as well as their harmful effects on health. After these reports, many consumers became afraid. Obviously, the Department of Health also became concerned. Also, over the past few years, you know that certain Chinese herbal pills have been put on the market. They were made either in China, or in North America. A few deaths have been attributed to them, which drew the attention of consumers and of the Health Department.

Consequently, we believe that the Health Department should pay very serious attention to this question.

• 1200

To give you a full understanding of the toxicity of these plants, we would like to give you a more complete overall picture of Chinese medicinal plants, and more specifically of their toxicity. I hope that you will be able to apply the elements we will have specified today when the time comes to draw up regulations for these plants.

Please let me first introduce our Chinese medicinal plants. There are about 5000 kinds of plants which are already registered in the dictionary of Chinese pharmacopoeia in China. Five hundred and nine of these plants are in current use by physicians and by the public. Among these 509 plants there are 22 species which are...

The Chair: Madam, we have all these things here. Could you state your recommendations to us? We can see the herbs and the products here.

Ms. Ing Dan Tran: Yes, yes but I would like to...

The Chair: Could you summarize just a little?

Ms. Ing Dan Tran: All right, but I'd like to go over...

The Chair: Could you just simply state your recommendations to us?

Ms. Ing Dan Tran: You want our recommendations right away? But you do not even know what the subject is yet.

The Chair: We have invited many groups who have explained to us what all these products consist of and we have visited stores and companies.

[English]

Ms. Ing Dan Tran: You can speak English with me. I can understand.

The Chair: I'm just trying to say that we have visited many sites. We have been to the herbal stores. We understand the products. They're not our products, but we understand this part of it.

What we really want to know now is your idea of where we can go. What are your recommendations? What can we do with this? It's not exactly what each product is. It's where we can go if we are going to change regulations. If we can go down to page 3, where you have your recommendations, I think that would be more helpful.

Ms. Ing Dan Tran: Okay, I understand. We're lacking time.

The Chair: No, it's not because of the time. It's just that we have gone through all of this. It's your recommendations we're looking for.

[Translation]

Ms. Ing Dan Tran: That's fine. So I would like to draw your attention to the fact that among these 509 plants, only 4% are toxic whereas 96% are not according to the dictionary of Chinese pharmacopoeia.

We'd like to emphasize that the toxic ones, when used in Chinese medicine, are very often combined with other plants in the same prescription. And when various plants are combined, their effects vary. For instance, their pharmacodynamic effect may be strengthened. The strongest effect is achieved when the various ingredients all react together as they are combined in a single prescription.

What might this reaction be? The particular effect of certain plants may be neutralized. There would be an absorption effect. Absorption means that when we associate certain elements by boiling them together, we create a chemical reaction among the various components, which gives a bond strong enough to completely change the characteristics of these plants and decrease their toxicity enormously.

Now let us state our recommendations. Given that only 4% of the plants are toxic and 96% are not, and are safe for public health... As you know, the safety of non-toxic plants is greater than that of peanuts. A few cases of deaths have occurred because of allergic reactions to peanuts.

• 1205

We would like to emphasize that these plants are very safe and we do not think it is necessary to draw up particular regulations for these plants. They can simply be considered as food, as tea or as coffee, when they are put on the market.

However, we would suggest that the 4% of plants that are toxic be sold under a DIN number. Their sale should not be prohibited because, as you know, some chemical medications are much more toxic than most of our plants, which does not prevent them from being sold, manufactured and marketed. A DIN number should therefore be assigned to toxic plants, if necessary.

The third recommendation also deals with plant toxicity. As you know, in China and Japan, for example, these plants have been extensively studied and analyzed. They have many years of experience in the use of these plants. They know all about the structure, the pharmacological action and the toxicity of them. We may therefore be able to refer to those studies rather than carrying out the same research if we want to have more knowledge about these plants to improve regulation of their use. Do you agree?

Ms. Mieu Tu Huynh (Association of Chinese Herborists of Quebec): I would like to have an opportunity to speak. I would like to add a few points. I would like to ask you to reconsider what you have prohibited, that is considering plants and natural herbs as medications and medicinal plants.

Among the toxic plants that you have looked at, I would like you to reconsider those that have been processed and boiled: their toxicity is reduced, if not completely eliminated. I wanted to tell you that.

The Chair: Would someone else from the group like to add something? No?

Who would like to speak here? Sir?

[English]

Dr. Yu Guang Sheng (Vice-President, Chinese Medicine and Acupuncture Association of Quebec Canada): I'm from the Chinese Medicine and Acupuncture Association of Quebec. I am the vice-president. The president is Dr. Hui, and the director general is Dr. Xie.

Today our association thanks you, the federal government, for taking the time to listen to our opinions on how to put Chinese medicine in a good position—good for people and good for Canada.

I'm from the Shanghai University of Traditional Medicine. Dr. Hui is from Hong Kong Chinese Medicine Institute. Dr. Xie is from Guangzhou University of Traditional Chinese Medicine. We are Canadians now.

We were in La Presse and The Gazette in Montreal, and CFCF-TV visited us, and it was reported in these papers. On TV they showed many cases we treated.

We treat patients according to the Chinese traditional principles of medicine—the yin/yang system, the five elements of circulation, and the formulas of different herbs together. Also, we diagnose using traditional medicine, meaning western medicine according to the X-ray, CAT scan, ultrasound, and blood, urine, and stool tests, etc. So this means integrated Chinese medicine and modern medicine, because it's good for the patient.

• 1210

Of course, acupuncture is now very popular in the world, including Quebec, with regulation. I think B.C. and Ontario will be legal.

Of course, there are herbs. We treat patients with traditional Chinese medicine and we use herbs. But in China there is university research and there are regulations, so it is in the same position as modern medicine.

If you want to be a Chinese doctor, you must study for six years at university, in the Chinese medicine department. It's the same for modern medicine and traditional medicine, because you need to learn more than the basics of medicine. For example, you need to know anatomy, psychology, chemistry, etc., and at the same time you need to study ancient Chinese medicine—a lot of books from ancient times. They are very difficult to read, particularly for French and English people, because the Chinese characters are très difficile.

We at our association in Montreal use herbs and acupuncture for our patients, of course, according to the traditional principles of medicine. We think, particularly for some difficult diseases—for example, late-stage cancer or fatigue syndrome or a virus infection—modern medicine until now has had no special drug treatment. But Chinese medicine balances yin and yang according to the body's system and gets good results. It's true.

In China, of course, there are scientific laboratories supporting it. Here it is a little bit difficult because there are no funds, no foundations for research in Chinese medicine. But a lot of clinical experience shows that...for example, for liver cancer the Hôpital Saint-Luc in Montreal saves about three months of life, but people who go to the Chinese clinic and get the Chinese medicine prolong their life for two or three years.

Some medical doctors, some nurses and nursing directors come to Chinese clinics and drink Chinese medicine. We ask, “Why do you want this? You are medical doctors.” They reply, “I know western medicine, but I also read Chinese medical books. I like it because it is natural.”

Anyway, I think it has much fewer side effects.

In some Chinese medicines there are some ingredients that make toxins, but in ancient China until now we know how to mix herbs together to make a formula to treat the toxins. This research is being done in Japan, in Hong Kong, in Taiwan, in mainland China. I think a very difficult program.... Research is now being done through laboratory analysis on how to make good results with no side effects.

• 1215

So our association's suggestion to the federal health department is to make a standard label, and the quality must be very good. There must be a history of study. For example, in China you must have a university degree from the university's department of Chinese medicine. Someone can't study for three or six months and become a herbalist. That is our opinion.

Thank you for your time.

The Chair: Thank you very much. We'll have some questions now. Madam Caplan, do you want to start?

Ms. Elinor Caplan: I have a couple of short questions. The first is to the herbalists. Do you think there's a role for Health Canada in making sure the herbal products are clean, do not contain foreign bodies or dirt, and are what they say they are when they are brought into Canada?

[Translation]

Ms. Ing Dan Tran: Are you talking about tablets that are made from herbs?

[English]

Ms. Elinor Caplan: No, I'm talking about bulk herbs as well.

[Translation]

Ms. Ing Dan Tran: No subproduct is added to herbs bought by wholesalers here.

[English]

Ms. Elinor Caplan: I'm talking about when they're imported. We've seen them in big drums. Do you think there's a role for Health Canada to make sure those products are clean and safe and nothing's been mixed into them before they leave the country? Should it have any role at all?

[Translation]

Ms. Ing Dan Tran: I do not understand really what you mean by "added products".

[English]

Ms. Elinor Caplan: One company told us it has someone inspect the product at the country of origin. It's then inspected again when it comes here, and then it cleans it. It also said it's possible for other companies not to have the same quality product; that what comes here may be full of dirt, or other products may be mixed in from the country of origin.

[Translation]

Ms. Ing Dan Tran: If you are talking about dust, it would be very difficult to regulate that aspect because, in China, there are a lot of producers growing these plants; sometimes they do not wash them well and there are bits of sand. If the Canadian government wanted to regulate that aspect, it could work with the Chinese Department of Health to establish standards for those products.

[English]

Ms. Elinor Caplan: That leads to my second question. Do you believe we should have the same standards here in Canada as they have in, say, China, when we're considering TCM? It's a question for both witnesses. Should the standards be the same in Canada as they are in China?

Mr. Robert Wong (Association of Quebec Chinese Herbalists): They should be different.

Ms. Elinor Caplan: Why should they be different in China than they are in Canada?

Mr. Robert Wong: Because they're different herbs. It's a different type of formula.

Ms. Elinor Caplan: If the Chinese medicine practitioners are trained in China and come to Canada and the herbal products have the same name in China as in Canada.... I don't understand what the difference is.

Mr. Robert Wong: You can't set one law for both sides, because in the east and in the west the medicine is different. You can't have one law to control both.

Ms. Elinor Caplan: I'm talking about traditional Chinese medicine and traditional Chinese herbs that are regulated in China and have standards. Do you believe those same standards should apply in Canada?

• 1220

Mr. Robert Wong: They should be combined, because there are differences. But that's why we have to work together. We have to make new laws or something to control it.

Ms. Elinor Caplan: I don't think you understand my question.

Ms. Mieu Tu Huynh: We hope the Government of Canada will communicate with the Chinese government and work together to find out a way to help the medication of Canada.

Ms. Elinor Caplan: Are there standards in China? Do they have standards that govern the herbs?

Ms. Mieu Tu Huynh: Yes, I hope so, because we would like to have the Chinese herbs both in Canada and in China.

Ms. Elinor Caplan: So you don't know whether there are any standards in China?

Mr. Robert Wong: In China of course they have standards, but when we bring the products into Canada nobody really knows which product can come in and which one can't. At the border today you have somebody there and tomorrow you have somebody else there, so they don't have the guidelines to control. You should make strict laws to control the border and tell people which specific products can come in. Today you have somebody there, but tomorrow you will have another person there. That's why it's difficult to say. You have to work together at the border.

Ms. Elinor Caplan: Thank you.

I'd like the same question answered by the Chinese medical practitioners. Do you believe the same standards that apply in China should apply in Canada? Even though it is provincial jurisdiction for the regulation of practitioners, the federal government does have a role when it comes to the regulation of the product.

Dr. Yu Guang Sheng: Yes, we think there should be the same standards, the same labels and the same quality. In China, Chinese medicine is the same as western medicine. They control Chinese drugs with the same standards and the same labels. There is no difference. Also, in Chinese universities there are courses in traditional medicine.

We think that if in Canada, in government departments, there are specialists and experts in Chinese medicine who examine the products using high standards, and if all associations make high-quality products, it will be very good for the Canadian people, because this is medicine, not food. It is not peanuts.

For example, the principal of medicine at Harvard University visited the Shanghai University of Traditional Medicine, and he said he thought there was only one medicine in the world, including Chinese medicine and western medicine, because it treats the patient. It doesn't say Coca-Cola. So we think there should be the same standards.

The Chair: Madame Picard.

Mr. Shao Li Ping (Association of Quebec Chinese Herbalists): In China, Hong Kong and Taiwan there is every manufacturer. If you want to make herbal medicines you have to get a licence. You have to show the prescription; that means on the package you show how many herbs are inside. So you have to apply for a licence and after that you can make herbal medicines.

The Chair: Ms. Caplan was asking whether you think the standards should be the same for any product that is sold in the same store. When we were in these stores, we saw on the shelves that the packaged products that were imported were all labelled and the ones from here were not labelled. That's what she was asking, whether you think there should be the same standards.

Mr. Shao Li Ping: Before there were some herbals with some animals...but now we cannot kill the animals. In those animals there are new...

[Editor's Note: Inaudible]

The Chair: Madame Picard.

• 1225

[Translation]

Ms. Pauline Picard: Ms. Ing Dan Tran, I believe I understood that you feel that the present regulations are adequate, but that, as the other lady said, there should be reconsideration of certain products that have been excluded or prohibited. You do not favour having a third category. You are saying that, if someone wants to claim that a product has therapeutic virtues, they can apply for a DIN. Did I understand correctly?

Ms. Ing Dan Tran: No. I was saying that if the government wanted to, it could require a DIN for toxic plants and not for the 96% of plants that are non toxic.

Ms. Pauline Picard: Are you satisfied with the present Health Canada regulations?

Ms. Ing Dan Tran: For now, yes. There are still no regulations on herbs.

Ms. Pauline Picard: So herbs are classed as foods?

Ms. Ing Dan Tran: Yes, at present.

Ms. Pauline Picard: If you believe that your herbs can treat a person who has poor blood circulation, can you put them on the shelf and say that an herbal tea, for example one made with blueberries, may be helpful in such a case, even if we do not know for sure if that herbal tea is good for blood circulation?

Ms. Ing Dan Tran: Right now, you have to consult your doctor, who could give you better advice. We have many herbs that can treat blood circulation, but it is up to us doctors to decide which herbs are the most appropriate.

Ms. Pauline Picard: So in your estimation the present regulations are satisfactory and you would recommend that persons with problems go to see a counsellor or an expert in Chinese medicine who will tell them to take this or that. Is that what you mean?

Ms. Ing Dan Tran: Yes.

[English]

Ms. Elinor Caplan: Are you aware that today you cannot legally make a medicinal claim for herbs in Canada?

Ms. Ing Dan Tran: Yes, I'm aware of that.

Ms. Elinor Caplan: So if you say there's no change, then traditional Chinese medicine prescriptions that come in packages would be able to make no claim. As Madame Picard said, if something from your tradition would be beneficial for circulation or heart or pain, you couldn't say that.

[Translation]

Ms. Mieu Tu Huynh: Normally there is a herbalist working with the pharmacy. If a patient is suffering from blood circulation problems, we advise him to consult the herbalist who will give him a prescription with which he can obtain herbs. We work together and we get very good results.

[English]

Ms. Elinor Caplan: When we were in the herb stores we saw not only the loose bulk herbs that were offered by prescription from Chinese medical practitioners; we also saw patent medicines that had been produced, but under the present regime they had to cover over the claim. No one could walk into the store, look on the shelf, and purchase with any knowledge of what good is this or how it should be used.

Ms. Mieu Tu Huynh: But normally we work in a pharmacy and we have a lot of experience with that. We talk with the patients and then we give them a consultation. We ask them to consult a herbalist.

• 1230

Ms. Elinor Caplan: So you don't believe that anyone should go into a herbal store and buy anything unless they've had a consultation.

Ms. Mieu Tu Huynh: Unless it's food, because natural food is very good for health. We put it on the shelf and then the patient can buy the food. Yes, that's easier.

Dr. Yu Guang Sheng: New in America now is a Chinese medicine, the herb named dan shen. It is now regulated in America, an intravenous drug for circulation, because in China university-level research showed key value, significance, and America repeated the research and said yes. So now dan shen is regulated in America for circulation. That's an example.

If a person goes to a herbal store and says he wants to buy a formula or that he wants this or that or twelve things together—I don't think so, because this its not good for the patient. It may result in problems because of the yin and yang. The patient doesn't know if there is too much yin or too much yang when he buys something. Every Chinese medicine is according to yin and yang, and if you're wrong, it's very bad for health. So I think the patient needs a prescription or a consultation from experts in Chinese medicine. Now, in Canada, yes, we're discussing it now.

The Chair: Does anybody want to add anything?

[Translation]

Have you any other comments? Yes.

Ms. Ing Dan Tran: When using the toxic herbs which we mentioned earlier, we must follow standards of dosage. These standards have already been described in the dictionary, which indicates how much should be used and for how long. When you go beyond the period recommended by the book, or if the dose is too large, you might have bad side effects. There are other restrictions which are indicated: for example, people suffering from high blood pressure or heart problems must not use certain herbs. For example, mahuang, or ephedrine, can cause rather serious damage. This is why it is important to follow the restrictions closely and to know how much must be used and for how long.

Ms. Mieu Tu Huynh: I'd like to add that some of our plants, such as liquorice, can be boiled and added to the prescription to reduce the toxicity of certain medicinal plants.

[English]

The Chair: Thank you very much. We'd like to thank this group for allowing your doctor friends here to join in with you.

Mr. Robert Wong: Can I have one—

The Chair: Okay. You can have the last comment and then we're going to stop.

Mr. Robert Wong: I have seen a lot of hospitals. You don't see too many oriental people there, in my view, and the reason is that we have our health foods, our natural things, and we take these day by day, so we prevent. We're talking prevention. So for you it's medicine, but for us it's part of our life. It's food and health. You can say it's medicine, but for us it's food.

• 1235

We like to use them it regularly, so that's why it helps a lot of people. It is a benefit for everybody. Maybe you don't see the amount that people are using. If you are talking about the product being brought from China, and the labels and that type of thing, they don't have those guidelines now. That's why we'd like to work together. The people have to study it now and then find a way to control it.

But you can't just control it, because you have to know what it does and why it is toxic or not toxic. We know the way. For example, this one is toxic, but we add something to balance it. That's why, if you're all the time saying something is toxic.... The water is toxic. So you don't drink water? You have a way to clean it up.

That's the basic thing. That's what I wanted to say.

The Chair: Thank you very much. Thanks to all of you. For those who are listening all day, we are going to adjourn. We'll be back at 2 p.m.

• 1236

• 1410

[Translation]

The Chair: We are resuming our sitting. This afternoon we are meeting three groups: the Syndicat professionnel des homéopathes du Québec, the Association des diplômés en naturopathie and the Syndicat professionnel des acupuncteurs et acupunctrices du Québec.

Ms. Larocque.

Ms. Claudine Larocque (President, Syndicat professionnel des homéopathes du Québec): First I'd like to thank you for inviting us. Given our expertise regarding the situation of homeopathy in Quebec, I think that we will be able to help the committee and share our knowledge of this field. We'd like you to know how much we appreciate this consultation which you're carrying on so that in Quebec and in Canada we might have the best possible regulations. Without any further ado, I will now read out the document which we have handed to you.

We are delighted with the initiative taken by the standing Committee on health and by health Canada in consulting various interveners in the alternative health field regarding the laws and regulations applied to natural remedies. These consultations allow us, as professionals, to enlighten the members of the parliamentary Health Committee regarding our day-to-day reality as homeopaths.

The members of the committee will afterwards be able to propose changes or amendments to the various laws and regulations presently enforced in Canada. Canadian professionals and consumers will then benefit from laws and regulations which adequately reflect reality. These new laws and regulations will allow Canada to become innovative and more rigourous in its regulation of natural remedies with its major trading partners. Canadian practitioners of homeopathy will be able to contribute, on an equal footing, to the development of the international homeopathic community.

Access to the full list of homeopathic remedies and pharmacopoeias recognized by Health Canada is therefore essential. Consumers, on the other hand, will be free to obtain all these high quality, effective, and safe natural remedies.

I will give you a brief overview of the Syndicat professionnel des homéopathes du Québec. Since 1989, the SPHQ has been a professional union affiliated with the Fédération des professionnels et professionnelles salarié(e)s et des cadres du Québec, to the Confédération des syndicats nationaux and to the International Council for Classical Homeopathy. Among other things, the SPHQ is the only Canadian organization which comes up to the strict standards of the ICCH.

The chief objectives of the SPHQ are: the study, defence and development of the professional, economic, political, social and moral interests of its members; the introduction and long term implementation of homeopathy; the independence of the homeopathic profession; the quality of the teaching and practice of homeopathy.

The SPHQ has 360 members throughout all regions of Quebec. All members adhere to a code of ethics, that we have given Mr. Préfontaine, statutes and regulations, that we have also included in our appendix, as well as the standards of 1500 hours of training over four years. Moreover, a professional oversight committee manages complaints from the public in order to ensure the best possible protection of public health given the absence of a formal professional association.

The SPHQ has several active committees: the research and development committee, the training committee, the admissions committee, the professional training committee, the committee for the Quebec Homeopathy Week and the communications committee.

The SPHQ has also produced various information pamphlets in English, French and Spanish. A 1-800 line enables us to answer questions from consumers and to properly receive complaints from the public.

In 1997, the SPHQ created the first Quebec Homeopathy Week, which closed with the Second International Congress on Homeopathy in Montreal, where a dozen foreign doctors and homeopaths offered to more than 250 participants from 14 countries the benefit of their homeopathic practice.

The SPHQ is actively involved in major issues: filing an application for a professional corporation, a test case that opposes us to the College of Physicians and which is before the Supreme Court of Canada, private member's bill 205 for the creation of an academic council, a brief following the tabling of the report of the interdepartmental committee on alternate medicines, the development of university training with the Université du Québec à Trois-Rivières, a pilot project for the creation of an alternative health care dispensary and federal and provincial political representations, as well as media liaison.

• 1415

In a nutshell, homeopathy was founded in 1796 by Samuel Hahnemann. The science and art of homeopathy are completely different from that of conventional medicine. Indeed, the point is to treat the entire patient, by intervening on the vital forces within that patient through homeopathic remedies.

Homeopathy does not treat disease; it treats the patient.

The three main laws of the practice of homeopathy are the following: the law of infinitesimal properties, the law of similitude and the law of individualization.

The homeopathic pharmacopoeia, be it French, German, American or Indian, is made up of vegetable, mineral, animal and human substances. In certain cases, they are nosodes.

We will not go further in our explanation of the rudiments of homeopathy. The Ontario Association of Homeopaths did so very well in the brief presented to your committee, and Health Canada enjoys highly-qualified employees who have the necessary expertise in the management and monitoring of homeopathic remedies.

The homeopathic reality of Quebec: first of all, the Charter of Rights and Freedoms gives each Quebecker the right to the therapy of his or her choice. The right to homeopathic treatment is therefore an established right in Quebec. There are no regulations governing the practice of homeopathy. In Quebec, in alternative medicine, anyone can practise anything, with the exception of acupuncturists and chiropractors who are governed by professional corporations.

Homeopathic remedies are accessible to the public in all major drugstore chains. Approximately 15 life insurance companies reimburse homeopathic professional fees and remedies.

Homeopaths who are members of the SPHQ all work in private practice, either individually or as part of a multidisciplinary clinic. Eighty-five percent of the population is in favour of the legalisation of alternative medicines, as demonstrated in a survey conducted by Multi Réso in 1992 for the Quebec Ministry of Health and Social Services.

Forty-five percent of those who seek out health care consult an alternative therapist, as also shown in the same survey. Between 1987 and 1992, homeopathic consultations have increased by 653% according to a Health and Social Services Ministry survey conducted in 1994.

The larger homeopathic laboratories, such as Boiron, Dolisos, UNDA, Reckweg or Holis are all present in Quebec and their products are distributed there. The sale of homeopathic remedies represents approximately 25 million dollars a year, with an annual increase of approximately 20 per cent. Pharmacists are authorized to sell homeopathic remedies, but their code of ethics prohibits them from practising homeopathy.

A few doctors practise homeopathy, despite the prohibition of their code of ethics and despite being harassed by the college of physicians. Veterinarians are the only ones who can practice veterinary homeopathy, but no standard of training nor any regulation governs their practice. The training establishments are all private, and six of them offer a training program that complies with our standard of 1,500 hours of training over four years.

A test case has opposed the College of Physicians and the SPHQ since 1991. We were first heard before the provincial court, then in Superior Court, more recently before the Court of Appeal and we should soon know whether we will pursue our case up to the Supreme Court.

Quebec homoeopathists must obtain certain homeopathic remedies in a clandestine manner in order to treat their patients with the proper remedy when it is indicated.

We believe that the SPHQ and Health Canada share certain common objectives. Quebec homoeopathist understand the concerns of Health Canada regarding supervision and regulation of natural remedies. We share certain objectives and our visions do concur: first of all, to ensure the protection of the public; secondly, to ensure that the public receives the best natural remedies possible; thirdly, to ensure access to natural remedies; fourthly, to encourage the best possible practice by our alternative health care professionals; fifth, to enhance the influence of Canadian alternative therapists internationally; sixth, to harmonize our legislation with that of Canada's major economic and professional partners.

• 1420

In developing our recommendations, we undertook careful research which was quite rigorous and we will share it with you. Our analysis of the current situation of the regulation of homeopathic products is based on an examination of the following documents: Good consolidation of the Food and Drugs Act and the Food and Drug Regulations; Good manufacturing Practices, fourth edition of the guidelines; Standard Manufacturing Practices, Supplementary guidelines regarding the manufacturing of medicinal plant-based drugs, final version, October 1996; Drug Release Program, Health Canada, Framework for an agreement on a mutual recognition of good pharmaceutical manufacturing practices compliance programs; Drug Directorate Directives, presentation of drug identification number applications; Therapeutic Products Compliance guide, January 1998; Regulation Amending the Food and Drug Regulations (1099) JUS-97-768-01.

The implementation as well as the enforcement of regulations of the Food and Drugs Act and the addition of relevant directives for importers, distributors and manufacturers of homeopathic medicines have significantly changed the conduct of the industry and led to the withdrawal from the market of certain multiple ingredients (compound products) and certain unitary products (a single product).

The withdrawals and prohibitions of sale can come in many forms: unacceptable manufacturing practices, non-compliant labelling; non-compliant advertising; use of excessively weak dilutions; delivery of a product in a form that can present a risk to health; use of narcotics; products listed in appendix F (prescription); and products listed in appendix D (biological products).

Although the industry was shaken by the enforcement of the regulations of the Food and Drug Act, none of the regulations or directives specific to the homeopathic industry seems to us abusive or unfounded, given that the current regulation does not mention infinitesimal or homeopathic doses explicitly. The Canadian homeopathic industry should develop comparable standards to that in foreign countries where the industry is older and where manufacturing standards are better established.

We have even observed a certain flexibility in the enforcement of the current regulations. Indeed, section C.01.034, C.01.038 and C.01.040 prohibit or limit the presence of arsenic, mercury, strychnine and chloroform in a drug. Similarly, other sections tolerate them only in certain concentrations: for example, B.06.003 in food colouring.

Point 1.4.2 of section 1.4, "Prohibited substances in homeopathic preparations" of the Therapeutic Products Compliance Guide authorizes the presence of these products in homeopathic preparations, specifying acceptable dilutions. In addition, the document entitled Standard Manufacturing Practices, Supplementary Guidelines regarding the manufacturing of medicinal plant-based drugs, "Analysis of the product" section, point 1.1, requires an analysis of homeopathic preparations containing potentially dangerous ingredients (analysis of identity and activity) to determine the activity of one or more dangerous ingredients or demonstrate that their presence cannot be detected.

We are in agreement on the enforcement measures in the regulations and the control of these products since they allow the sale of over 40 homeopathic remedies without limiting access unreasonably. According to the current regulations, the weakest dilutions possible for these products vary from 3X to 8X. The 8X is generally the lowest dilution used in the preparation of homeopathic remedies made up of multiple or single ingredients.

We wish to point out that the Therapeutic Products Compliance Guide has no legal standing, but is used as a guide for the industry to apply the regulations. This raises the fact that in the absence of specific regulations regarding homeopathic remedies and infinitesimal or homeopathic doses, Health Canada must exercise flexibility in the application of directives that should be uniform for all.

• 1425

Currently, the vast majority of homeopathic products are sold freely in Canada if they are in compliance with the standard manufacturing practices and the specifications of one of the following pharmacopoeias: the Homeopathic Pharmacopoeia of the United States, the French Pharmacopoeia or the German Homeopathic Pharmacopoeia, whose title I will let you pronounce, namely Homopathische Arzneimittel.

However, despite the evolution of the application of regulations to the homeopathic industry, over 60 remedies continue to be prohibited as they are identified as narcotics or part of appendix F (prescription) or appendix D (biological products).

In the context of weighted dosages, the current prohibitions and limits are well founded. However, with regard to infinitesimal or homeopathic doses, there is no justification and we not feel it is necessary to detail the various principles that guide the manufacturing by successive dilutions (or deconcentrations) of homeopathic remedies, which means they are non-toxic when the deconcentration is sufficient. Moreover, if the products are manufactured according to the instructions of one of the three homeopathic pharmacopoeias, the risk to consumers is nonexistent.

It is the manufacturing process that determines whether a product can be called "a homeopathic remedy", and not its use or content.

Here are our recommendations.

Since Health Canada has introduced sound manufacturing practices for homeopathic remedies and recognizes the validity of the American, French and German pharmacopoeias, we have formulated three recommendations:

- First of all, that compliance with manufacturing standards heretofore determine the labelling of a product as a "homeopathic remedy" and not its use or content.

- Secondly, that homeopathic remedies be excluded from the list of narcotics in appendices F and D, and that section C.01.034, C.01.038 and C.01.040 not apply to this category of products if there has been compliance with the Standard Manufacturing Practices and the manufacturing instructions of one of the three recognized pharmacopoeias.

Thirdly, that joint consideration be undertaken of the definition of prescriber, so that professionals in various provinces not be unduly affected by the absence of provincial legislation governing the practice of our professions.

In conclusion, we are happy to have been able to help the Parliamentary Committee on Health and Health Canada with our homeopathic expertise. We would appreciate being informed of ongoing developments in the work of your committee. Please rest assured of our full co-operation and our desire to respect the various laws and regulations that govern and oversee natural remedies.

We are aware, as you are, that an act and regulations that are too strict and that are not appropriate might give rise to a black market in natural remedies. That would be disastrous for Health Canada and for the Canadian public.

We are confident that Canadian regulations on natural health products will enable Canadian homeopaths to have access to all the homeopathic remedies and to continue to contribute in their way to the well-being and the improved health of the Canadian public.

In appendix 1, you will find articles relevant to regulations; in appendix 2, the list of prohibited homeopathic remedies; and in appendix 3, letters of support from various organizations that support the steps we are taking and the recommendations that we are presenting today, including the Swedish Homeopathic Association, the European and International Councils for Classical Homeopathy, the Professional Association of Swiss Traditional Homeopaths and the Norwegian Homeopathic Association.

The Chair: Thank you. Do the people accompanying you wish to speak or are you ready to answer our questions?

Ms. Claudine Larocque: We are ready to answer questions, if you wish.

The Chair: We will start, then. Ms. Caplan.

[English]

Ms. Elinor Caplan: Thank you very much for your presentation. I believe you presented before in Ottawa as well. This is the second time you've appeared before the committee.

Ms. Claudine Larocque: Yes, but today it's for le Syndicat professionnel des homéopathes du Québec. In February it was for la Fédération des professionnels et professionnelles salarié(e)s et des cadres du Québec.

• 1430

Ms. Elinor Caplan: I'm curious about your recommendations. The last recommendation is the regulation of professionals, and that is entirely provincial jurisdiction. Are you aware of that?

Ms. Claudine Larocque: Yes. It's just because in some text of the regulation we're talking about the prescriptor, and in brackets it always says “prescriptor” has not been defined yet, but it will be and should be.

Ms. Elinor Caplan: The point I would make is that the federal government has no responsibility or authority to define the prescriptor. That's entirely up to the provinces. I don't believe the provinces would be welcoming federal intrusion into that jurisdiction.

The other recommendation you made that I wanted to discuss for a moment is the one where you recommended process as opposed to product. Could you expand on that a little bit for me, please? How would that work?

Ms. Claudine Larocque: Okay. Florent will answer the question for you.

[Translation]

Mr. Florent Tremblay (Vice-President, Syndicat professionnel des homéopathes du Québec): Yes, as soon as you talk about manufacturing homeopathic products, you are dealing with major world-wide principles. We do not believe that we have to consider the root source of each product or, in other words, know what type of plant was used and what its toxicity was, since the rule and principles involved in manufacturing homeopathic products make them non-toxic. The way to define a homeopathic product is not by studying its content and its dilution, but by looking at the manufacturing principles used. That is the rule used to define these products elsewhere in the world.

[English]

Ms. Elinor Caplan: And you're satisfied, or you believe Health Canada should be satisfied, that because there are good manufacturing practices, GMPs, in place for the production, we should not then be concerned about whether the product, the end result, is safe? Quality has been established, but it's a question of safety or efficacy. You don't believe Health Canada should have a role in the efficacy or the safety of the product? Do you assume that because of good manufacturing practices, it is good quality and safe, and therefore that's all Health Canada should be concerned with? Is that your position?

[Translation]

Mr. Florent Tremblay: Yes, exactly. Everything is based on the manufacturing. Of course, it is the quality control during the manufacturing process, that is the compliance with the Good Practices, that is the determining factor. In fact, all the pharmacopoeia, wherever their country of origin, have extremely precise standards for everything from collection to storage. Everything is very detailed and there is no real risk for the consumer. The only risk is that the manufacturing rules might not be followed and that the product could be of poor quality. That is a fact, but after consulting a number of comparable works abroad, I have concluded that everything that has been done up to now is quite remarkable. It is very well done.

[English]

Ms. Elinor Caplan: This will be my last question, if I can.

Do you believe homeopathic products produced through a method with good manufacturing practices should be able to make health claims, and if so, should they have to produce evidence of the claim they are making?

Ms. Claudine Larocque: Yes, I do agree.

Ms. Elinor Caplan: Yes, they should be able to make claims, and yes, they should have to produce evidence appropriate to the claim they're making?

Ms. Claudine Larocque: Exactly.

Ms. Elinor Caplan: Thank you very much.

The Chair: Madame Picard.

[Translation]

Ms. Pauline Picard: I have a short question and a comment. I quite agree with Ms. Caplan about the many organizations representing naturopaths and homeopaths who do not have a professional body at this point and who have asked us to put pressure on Health Canada. I should remind you that the management of health care is under the jurisdiction of the provinces. It is therefore up to them to recognize professional bodies, as has been done in Quebec for acupuncturists.

• 1435

Ms. Claudine Larocque: I would like to add that certain federal regulatory texts define a prescriber as a person who is automatically a member of a professional body, as a doctor, a veterinary doctor, a gynaecologist, an obstetrician, etc. We wanted to make a distinction between the use of the term "prescriber" for non-natural remedies and its use for natural remedies.

Ms. Pauline Picard: My colleague and I, she in English and I in French, have reacted the same way. My first question dealt with recommendation 3.

Ms. Claudine Larocque: It is perhaps poorly worded.

Ms. Pauline Picard: It is not clear.

Ms. Claudine Larocque: Yes, I agree.

Ms. Pauline Picard: In your presentation, you said that the industry's standards were comparable to those in other countries where homeopathy has been around for much longer, for a century. It is almost new here. In your opinion, which country has the standards that are the most useful and that you would suggest as a model?

Mr. Florent Tremblay: Health Canada recognizes three major pharmacopoeias, which we have cited. Where homeopathy is concerned, the American pharmacopoeia is a copy of the French or German pharmacopoeia. These are the two that dominate by far in Europe. A number of countries have similar pharmacopoeias. The Belgian industries can use the Belgian pharmacopoeia or the German one. In practice, it is really the French and German pharmacopoeias that are the most widespread, the American one being a sort of copy.

Ms. Pauline Picard: That is the one that you are now using as a basis?

Mr. Florent Tremblay: Yes. That is the basis, the German copy being the oldest.

Ms. Pauline Picard: All right.

Mr. Florent Tremblay: And the most rigorous also, to tell the truth.

Ms. Claudine Larocque: We are very pleased that Health Canada has authorized these three pharmacopoeias because these are the ones referred to by most serious homeopaths around the world.

Ms. Pauline Picard: Thank you.

[English]

The Chair: Excuse me. I got a little bit confused, I think, or else you didn't understand when I asked before whether the other groups wanted to speak. Did you mean you didn't want to speak on hers but you did want to speak on yours? I would have heard all three of you first. Okay, well, let's go ahead.

Madame Renaud, would you like to speak now? I meant to hear all three of you first and then ask questions. That's what I meant when I asked if you wanted to say anything, and you said no.

Madame Renaud, go ahead.

[Translation]

Ms. Nicole Renaud (President, Association des diplômés en naturopathie): Thank you for inviting us to express our point of view today.

I will start by presenting the Quebec Association of Naturopathy graduates. The Association obtained its letters patent under the Loi sur les compagnies on December 14, 1993. Its head office is in Quebec City, or Sillery, actually. The Association now has more than 110 members, including 85 active members, who practice naturopathy on a full-time basis, while the other members are supporting or student members.

The executive consists of myself, as President, a Vice- President, Mr. Gilles Parent, who is a naturopath, a secretary, Ms. Christiane Gendron, who is also a naturopath, and a treasurer, Ms. Céline Adam. The three directors are Ms. Monick Juliette Élie, a naturopath, Mr. Maurice Nicole, a naturopath and aromatherapist, and Ms. Ghislaine Martin, who is also a naturopath.

The Chair: Ms. Renaud, could you go directly to your recommendations?

• 1440

Ms. Nicole Renaud: I would have liked to tell you about the training since it is an important aspect relating to our recommendations. Could I read my presentation a little more quickly?

The Chair: We have already heard other presentations on the same topic.

Ms. Nicole Renaud: All right, I will give you a summary then.

At present, the training consists of 1000 hours of lecture courses. Our association has established the standards and our presentation gives you the general requirements. Naturopathic training in Quebec is based on the various training programs that exist in Europe and throughout North America. This is the training that is currently given in serious schools. The program focusses on excellence and is aimed at training future naturopaths with the qualifications and skills required to exercise their profession in accordance with a regulated code of ethics.

Practice: Naturopaths are therapists that have the proper training to be able to dispense health care, educate the public, help people under conventional treatment, prevent illness, etc. They do not provide medical diagnosis. We use natural substances such as vitamins, minerals, amino acids, plants, plant buds, organotherapy products and tissue extracts. We are qualified to prescribe these remedies. We also use laboratory tests.

The concern that naturopaths have about the regulations are in the area of natural remedies. The former Minister of Health, Mr. Dingwall, said: "Our goal is to protect the health of Canadians, and not to limit access to safe and effective medication."

As was already mentioned, we use remedies based on medicinal plants. In the Food and Drugs Act, health products are classified and regulated as food or drugs. They are listed along with marijuana, among other things, it goes without saying that a food taken in excessive amounts may cause health problems.

According to the advisory committee's preliminary report, health products sold on the Canadian market should be regulated according to their benefits and risks. If the products offered on the market were analyzed, it would be shown that some of them do not correspond to what is written on the bottle and that, as a result, both the health risks and the health benefits are negligible.

It is important to realize that natural health products are unique in terms of their manufacturing, their composition and their effects. There are more and more consumers of these products. The benefits of natural remedies for health and the health system should also be taken into account, since these remedies save the government money. Natural health products are used to maintain and improve health, and to prevent and treat disease. There is absolutely no mention on the bottle of what type of illnesses the remedy is prescribed for.

For centuries, naturopaths have been using plants and natural products in their practice. Some biological products have undergone significant transformations that have made them non-toxic, but also without any therapeutic value. Naturopaths today use quality products which are proven and safe and which are manufactured using standards that comply with market regulations. These products are as effective as possible in order to meet patient needs.

Our recommendations are as follows. It is true that many consumers buy natural remedies in pharmacies, unaware that natural food stores also offer these same products or equivalent ones. Consumers go to pharmacies because the cost of these remedies is much lower. It might be good to analyze the products to find the answer. Unlike naturopaths, pharmacists have not received adequate training to be able to prescribe one remedy or another or even give appropriate information about the product. Pharmacists have been trained to direct consumers to medication and to inform them about medication. Naturopaths have been trained to direct consumers to natural remedies and inform them about how the remedy should be taken.

Our Association therefore recommends that naturopathic training be considered the appropriate training for informing consumers about natural remedies based on plants, vitamins, minerals, amino acids, etc.

The Association recommends that products based on herbs, vitamins, minerals, amino acids or any other natural products available in the American pharmacopoeia also be available to naturopaths and consumers in Canada.

• 1445

The Association recommends that a research group be established to carry out investigations of studies and research results published in scientific, medical and health journals and relating to various natural remedies, and to prove the effectiveness and the non-iatrogenicity of products based on herbs, vitamins, minerals, amino acids and other natural products.

Although the Association agrees with Health Canada's policy regarding quality, compliance and manufacturing practices for natural products, it recommends that Health Canada ensure that control measures be stricter and they be complied with by manufacturers of natural products to enable consumers to use high- quality natural products.

I would point out that our document does not deal with homeopathic remedies.

That is all.

[English]

The Chair: Merci beaucoup.

Luc, do you want to cut this down to something shorter?

[Translation]

Mr. Luc Martineau (Vice-President, Information and Training, Syndicat professionnel des acupuncteurs et acupunctrices du Québec): Luce Prévost and I are acupuncturists and members of the Syndicat professionnel des acupuncteurs et acupunctrices du Québec. In Quebec, there are currently 520 acupuncturists who are members of the professional body of acupuncturists and about 100 of them are members of our voluntary association.

We prepared the submission you have before you. I will not read it, given the time constraints, but I will read a summary in English. I will then answer your questions. That will be a lot easier.

[English]

Our association would like to submit its point of view on Chinese pharmacopoeia and its use by the acupuncturists. A great majority of acupuncturists are interested in Chinese pharmacopoeia for two reasons: they compensate the limits of acupuncture by using pharmacopoeia, and the basic training in order to write prescriptions in pharmacopoeia is similar to the training of the acupuncturists.

In order to improve the use of Chinese pharmacopoeia by the acupuncturists we need to meet three important conditions: the creation of a third category other than food and drugs, which would be natural health products; the improvement of quality control on these products; and recognition of the traditional knowledge.

In Chinese pharmacopoeia there are two relevant books that are recognized worldwide. These are the books we talked about this morning: Chinese Herbal Medicine by Benski and Chinese Herbal Medicine: Strategies and Formulas by Benski and Barolet. These books are the basis of acupuncture training in the United States. Recognizing in Canada the existence of such knowledge, the new Canadian legislation would encourage more professionals to study Chinese pharmacopoeia in order to serve the Canadian public in an efficient and secure manner.

[Translation]

Before coming here, I spoke with the president of the professional body of acupuncturists in Quebec about the fact that we are here to ensure the safety of the general public and the dissemination of this knowledge. The clinical work of acupuncturists is overseen through professional inspections, since they are members of this professional body. It is well known that acupuncturists use more than just their needles in their clinics; they use the Chinese pharmacopoeia, trace elements and homeopathy. It is important to recognize the Chinese pharmacopoeia aspect and the yin aspect, that is the material or substantial aspect of this medical approach. They go together. Ms. Tousignant was explaining to me that this federal legislation affects us because amending the Act would enable us to practice freely.

At present, the Act governs food and drugs, but we do not have a category for natural health products, and that is why we would like to see these important changes to the Act. There are difficulties on three fronts, first of all, with respect to public safety. If traditional knowledge is not recognized, how do you think experts will become interested in this traditional knowledge? Second, how could professionals possibly use these products if the traditional knowledge is not recognized? There is obviously a need for a framework to monitor the knowledge of these professionals. As regards quality control, everyone is in favour of virtue, pharmacists and everyone else. However, quality is evaluated in accordance with the Materia Medica. To assess plant quality, you need knowledge in that field. And as is explained in the document about the claim of the Association of Canadian pharmacists, pharmacists are not automatically experts in medicinal plants.

• 1450

We were shocked when we read about a recent study written up in the Journal of the American Medical Association and which was referred to this morning, that found that 106,000 people die every year in the United States and at least 10,000 in Canada from the side effects of medication. This cannot be ignored even if the study was not carried out in Canada.

Given that reality, we're talking here about cabbage and carrots, while... I will try not to get angry, and to speak calmly.

The main point I wanted to raise was about the recognition of this knowledge.

[English]

Ms. Elinor Caplan: Only the medicinal properties of cabbages and carrots. That's my joke.

Some hon. members: Oh, oh.

The Chair: Luc.

Mr. Luc Martineau: That's fine. I think you have the document.

[Translation]

The Chair: Madam Picard.

Ms. Pauline Picard: You are inviting me to ask my questions right away?

The Chair: Yes.

Mr. Luc Martineau: This morning, we were not given time for questions.

Ms. Pauline Picard: But I am not ready. I thought you were going to continue.

[English]

Ms. Elinor Caplan: Thank you very much. I'd like to ask a question, and I'd like everyone to answer and I'll see if I understand what would be acceptable.

As you know, our committee is going to be making recommendations to—and I'll use the word in a non-partisan way—liberalize the access to herbal remedies and natural products, and our mandate says that as we give people greater freedom we have to assure ourselves that the products are safe and that they are of good quality.

The mandate says nothing about efficacy. If we were to recommend that quality be defined as the process of GMP, good manufacturing practices, that safety would be the inspection that what is in the bottle, what is in the caplet, agrees with the label, would you agree that this meets the test of quality and safety from your perspective?

Mr. Luc Martineau: If there's a billion dollars worth of natural products for sale right now in Canada with the actual legislation, what would an improvement in this legislation represent? It would probably represent that we would grow to $6 billion, exactly what is the state of business in West Germany with these products.

If we have quality products, if we have secure products, but more than that, if we have health practitioners whose knowledge we recognize and we register them—

Ms. Elinor Caplan: I must stop you. That is something this committee cannot recommend. As Madame Picard said, and as I have said previously, the regulation of health practitioners is entirely provincial. This is not an issue for this committee. This is not an issue for the federal government.

We are only interested in the products at this time and access to those products, ensuring that they are safe and of good quality. At the present time, Health Canada's mandate includes efficacy. What we are discussing here is whether or not there is a method that would recognize traditional use or evidence appropriate to the health claim that would not be as rigorous as the research required for drugs.

To explain, in the situation as it exists today, foods cannot make health claims. In order to qualify for a drug identification number, you have to prove you're a drug. There are many things, as we heard this morning, that fall between the cracks. When we talk about the term “efficacy”—I want to thank the chair for suggesting I explain that—it has to do with whether or not it will do what it says it's going to do. And if it's a drug, which is usually high-risk but not always, it has to go through drug trials and expensive research.

Mr. Luc Martineau: This we know.

• 1455

Ms. Elinor Caplan: One of the concerns that people who use natural products have, and they tell us this, is that these products are not harmful—many of them are safe, they're not harmful—so why should they have to go through the same rigorous research as harmful drugs?

So the question I'm asking you is do you think it's possible to have a regime that does not require the same double blind trials, clinical trials and expensive research on products that, by the test, could be considered low-risk or safe and of good quality? Is it possible to use, as some other jurisdictions use, a disclaimer on the label that says that this has not been researched; however, it's for traditional use or as the pharmacopoeias and the monographs internationally have suggested. Do you see that model as an option for this committee?

[Translation]

The Chair: Ms. Renaud.

Ms. Nicole Renaud: When I read all the documentation that Health Canada sent me, I learned that there are some products such as certain amino acids and melatonin, that cannot be used because they have not yet been researched. The question of public safety was also raised. It is clear that products currently sold in pharmacies or in natural food stores do not present any danger since the dosage is indicated. I do not know if you remember, since you come from Ontario...

[English]

Ms. Elinor Caplan: But they cannot make health claims. It is illegal for those products to make health claims.

Ms. Nicole Renaud: Illegal? Do you mean—

Ms. Elinor Caplan: It's against the law.

[Translation]

Ms. Nicole Renaud: Melatonin and amino acids?

[English]

Ms. Elinor Caplan: Melatonin isn't on the shelf, but many products—

Ms. Nicole Renaud: Yes, I know.

Ms. Elinor Caplan: —that are on the shelves in health food stores today cannot legitimately, under the law, make a health claim.

Ms. Nicole Renaud: I know, but that's why—

[Translation]

Excuse me, I will speak in French. We want to be able to use the products that are approved by the American pharmacopoeia because they do not present any danger. You can check all the studies that have been done in the United States.

[English]

Ms. Elinor Caplan: So you would support a model that would permit a disclaimer that says Health Canada doesn't guarantee the effectiveness; however, this is listed in the pharmacopoeia—something like that?

Mr. Luc Martineau: I've read this—

[Translation]

Ms. Nicole Renaud: Yes and no. Ms. Caplan, we are afraid that people will get products that have no therapeutic benefits and whose composition is incorrect, among other things. That is harmful to our practice.

[English]

Ms. Elinor Caplan: I would argue, if I could, that people are telling us they want the freedom to choose, especially those things that will not hurt them, and to decide for themselves whether or not it's effective for them.

Mr. Luc Martineau: Ms. Caplan, where is your committee now on the third option, which is to have a separate system, where it is neither a food nor a drug and then you can create your own regulations. There's a no-end discussion, and you know that. You've seen these reports.

Ms. Elinor Caplan: Yes, I did. The committee has not made a decision. My own view is that, rather than a third category, what we need is an alternative process to assess those things that are neither food nor drug. It's not the category but the process for assessing them to ensure there is quality and safety. If you have some ideas for us, we've heard many people who believe that if we just go along and develop a third category, then that will use the same method of judging them. So I believe we have to find a way that is different from either foods or drugs to assess those things that we have traditionally held as foods but want to make health claims on.

• 1500

Mr. Luc Martineau: I would have so much to tell in the direction of a third category, instead of trying to integrate it to the actual system. I've seen so many...and I mean no disrespect to other people, but this knowledge does not exist right now. The scientific community hasn't taken the time to study this.

The director of the faculty of pharmacology at Laval University, Monsieur Barbeau, is a fine person. I went to his presentation, and he is going to Europe for one year, full-time, to study herbal medicine in England and Germany. He's the director of the pharmacists faculty. He doesn't even know the uses for Panax quinquefolia, and he admits he doesn't know.

Right now, you need a new set of experts who can keep up with the pace of Canadians. This $1 billion industry is going to get to $3 billion or $4 billion. It's going to grow very quickly. This law only changes every 60 years, so you need to see ahead of you, not make it whatever.... You need a new system, a third category.

Ms. Elinor Caplan: The only thing I'd like to say is that I'm not sure a new system is.... I agree that we're looking at a new system that will liberalize access while we ensure quality and safety. Whether that new system includes evidence around efficacy or not is the big debate, as far as I'm concerned.

I'm not sure, and this committee hasn't decided, whether we need new legislation or another section under existing legislation. When you say a third category, to me that suggests just a subdividing of the existing act, and we haven't made that decision.

[Translation]

The Chair: Ms. Picard.

Ms. Pauline Picard: I have a question for Ms. Renaud. Still, there is a problem, you have to admit. I am a consumer of natural products. I am turning 50 and I have always tended toward alternative medicine. I therefore take natural products.

However, since we have started this study into natural products, I have become much more aware of the various aspects of these products. I go into pharmacies and I look at the different products and their brands. The other day, I wanted to buy some echinacea. I therefore began to look at the brands and I stopped to read them a little more than usual. What is going on? There is practically no information on the label, although the dosage is given. One company, one brand had a product that contained such and such a quantity of echinacea. I looked at four of them, and all four were different.

I therefore thought that if even I cannot make out what is what, even though I am more knowledgeable than other people about this issue having studied it since December and having heard a lot about it, how will average consumers manage? They buy anything. They do not know what quantity is contained in the product they are buying. Something has to be done.

What we are asking you—we are not here to judge anyone—is to tell us what we should recommend to the Health Department to ensure that consumers are informed about the products they buy.

Ms. Nicole Renaud: That is why I am asking Health Canada in my recommendations to increase monitoring measures. You are right, Madam. Some companies... There is a regulation that supposedly manages... I also have a bakery, Madam; the government came to see me to see what was in the bread that we make.

Does the government also ensure that other company products conform to what is on the label?

Take garlic, as just one example. Some producers put extracts into tablets. Others just sell garlic powder, like the powder you sprinkle on food or something.

• 1505

I therefore think that you are right with respect to your echinacea. Of course, it could be an extract of purple echinacea or some other variety of echinacea, which makes a difference.

I think it would be important to have regulations on production and products, so that the public isn't tricked, so that people do not spend money for ineffective products. That is what I say in my submission. Such a product has no therapeutic effect and poses no danger; it does not contain anything.

The regulations therefore need to be stricter. According to what I have read, there are stricter regulations. That is the point of view that we are defending, as naturopaths.

Ms. Pauline Picard: As a naturopath, does the training that you receive enable you to determine whether the effectiveness of echinacea on a person depends on how much of certain ingredients is present, owing to the fact that there is a certain percentage in the plant? I imagine that you are also consulted by the laboratories making these products. How do you chose one laboratory rather than another?

Ms. Nicole Renaud: Madam Picard, naturopaths who are currently members of our association have received adequate training. This is not, however, the case of all the naturopaths in Quebec, because some of them are self-taught while others have bought their diploma. The training that these naturopaths have received must be scrutinized.

Certainly, we are approached by a number of laboratories. During our training, even though given companies are not mentioned, we are taught how a product must be manufactured in order to be effective. This training helps us chose certain products. We also experiment with them a lot in order to know how effective they are. Product studies are done as well.

Mr. Luc Martineau: Madam Picard, the shortcoming in the legislation is that, by classifying echinacea as a food, it authorizes the manufacturer to put as little as 10% echinacea in a product and still call it echinacea. As long as it is considered a food, a medicinal plant will be subject to the control measures that apply to foods. The FDA does the same thing, except that it adds a claim, which is also subject to control.

What is important to understand is that the present legislation is extremely discriminatory where medicinal plants are concerned. In spite of this fact, Canadians and Quebeckers have protested by continuing to buy these products. It is not because of publicity or because they are for sale, but because the other system is increasingly ill suited to their needs. That is why they are buying these products, despite the shortcoming.

I have worked with people who are in Famili-Prix and I saw products—should I name them?—that contained only 10% ginseng. The type of ginseng was not indicated either, even though there are three types. The consumer has no information at all.

The present legislation is extremely detrimental to medicinal plants. And yet their popularity is growing tremendously. I am amazed that they sell so well despite the very poor quality. It really takes an expert to find the product you're looking for.

That is why I say that the Association of Canadian Pharmacists is not asking for the status quo for nothing. It is not for nothing, far from it. That is why I say that the changes happening in the health field in Quebec and Canada are a genuine small revolution. I hope that the committee will be able to deal effectively with these issues.

Ms. Pauline Picard: Thank you very much.

[English]

The Chair: Thank you very much.

Thank you all for appearing, and some of you for staying on and coming back. Maybe we'll see you again.

If you have any more comments for us before we make any final decisions, we'll be glad to hear from you.

Next is l'Association nationale des produits de santé: Denise Poirier; André Aubé; André Lavallée; and Roger St-Laurent.

• 1510

[Translation]

Would one person like to speak on behalf of all of you or would each person like to speak? We will start with Ms. Denise Poirier.

Ms. Denise Poirier (National Health Products Association; President, Robert et Fils Inc.): Hello.

I would like to tell you a bit about how the Canadian legislation affects us, especially with respect to one product. This is a composition based on vitamins and plants. We have been debating this formula since 1970 because the product contains comfrey. In 1970, it was on the market; the formula, by the way, has been used for mor than 70 years. It has always worked very well. However, the Act created a debate about the type of comfrey and the part of the plant that could be used.

At that time, we were using the leaves and stems. We were told that we could no longer use anything but the leaves. We therefore came up with a new formula and redid the labelling as a consequence. When all that was done, we were told that we would no longer use the leaves but only the stems. To make a long story short, we went from 1970 to 1973, to 1979 and to 1982, when we obtained approval for comfrey, which was withdrawn in 1988. Since then, we have had to change the composition to incorporate something else and finally withdraw the product from the market because it was no longer as effective, since comfrey was the component that gave it its main property.

My remarks lead to a question. As a manufacturer, how does one work with the department or with the Therapeutic Products Directorate in order to be able to survive? We are a small company. We have been in operation for 61 years, we have strict standards for the manufacturing and processing of our products. We have two microbiologists and biochemists on site; moreover, responsible laboratories manufacture certain products for us, as needed.

How can we operate as manufacturers and understand what has to be done to survive in this jungle of legislation and government intervention?

That is the main thrust of my presentation because I know that we don't have a lot of time. If we have another minute, I could tell you about another problem which happened to me, or rather to us, concerning the DIN application for two products. I will not identify them for fear of the DIN allocated to me being withdrawn. Let's say that they were both called Pierre: Pierre 1 and Pierre 2. So the DIN application in both cases was made to you at the same time. In the case of Pierre 1, the formula for children, the application was accepted. However, in the case of Pierre 2, which had the same ingredients although in a higher dosage but still controlled, the application was refused. The name Pierre was not accepted because it referred to something specific. However, Pierre 1 was accepted, whereas Pierre 2 was refused because of the name which meant something tangible, specific and concrete. So, our application was refused.

These are the two experiences I wanted to tell you about. I'd like to know what you think about them. I would ask you once again what we should do, as industrialists and as business people, to survive with this kind of legislation you impose on us. Thank you for listening to my views.

[English]

The Chair: Maybe things have gotten reversed. We want you to give us ideas and we're going to ask you the questions.

[Translation]

André Aubé.

Mr. André Aubé (National Health Products Association; President, Les Produits Naturels Magistral Inc.): Good afternoon, Madam Chair, lady members of the committee. I'm very pleased to see that women are more persevering than men; if there were fewer women on this committee, I think there would be no one left to listen to us. So thank you.

• 1515

[English]

The Chair: If I can interrupt, usually there are 16 members on the committee. We were in Vancouver and some of them went there. We were in Toronto and some went there. We spread ourselves out. Also, we have to be in the House of Commons at the same time as we're here, and that makes it a little difficult. So we have to restrict the number who can be on the road all the time; otherwise we would all be here.

[Translation]

Mr. André Aubé: Thank you for that clarification. I will speak in French if I may. I feel far more comfortable in French than in English and I hope that you will have no problem following my presentation. I am sure it will be helpful to you, because I don't think that any other witnesses who appeared before you have had such strange experiences as those I am going to relate to you.

Since 1995 in the United States a product with the name of chitosan has been distributed on a large scale. The claim made for it, and under which it has been marketed primarily, is that it helps people to lose weight. It sells in enormous quantities in the United States.

In late 1995 and early 1996, an effort was made to sell it in Canada for the same purposes, namely to help people lose weight. Health Canada intervened and banned the sale of the product. I'll come back to this point.

At the same time as people began to distribute chitosan in the United States as a product which would presumably be effective in helping people to lose weight, I met with researchers from the University of Sherbrooke who had been working for five years on animals to establish the effectiveness of chitosan in reducing cholesterol rates. After meeting, we concluded an agreement and they stopped working on animals.

When Health Canada decided to prohibit the distribution of chitosan in Canada, it gave as its reasons the problems resulting from the absorption of vitamins by this product, mainly lipid- soluble vitamins. In the view of Health Canada, there was a risk that certain lipid-soluble vitamins might be conveyed through Chitosan at the same time as cholesterol.

I would point out that I agreed with them; I fully shared the fears of Health Canada. That is why my company decided to discuss the problem with a group of researchers working within CUSE, the university health centre of the Eastern Townships. That is the main hospital centre in the Eastern Townships. Large-scale clinical research is conducted there.

We therefore entrusted—and I would point out immediately that we are not a multinational company—to these very competent people a clinical study of 32 patients, as this was considered to be a statistically valid number for obtaining fully reliable results.

The work was carried out throughout 1997. In December of that year, the research team tabled its report which showed beyond any doubt that the product was totally safe. We have submitted a document to you, the one with a grey cover, which will allow you to verify the competence of the researchers who carried out the study. At the same time, it can be seen that not only was the product safe but also that it was very effective in reducing cholesterol, and that it could even be distributed in Canada as a food supplement.

I indicated to you earlier that we are not a large company. This work cost us close to $300,000. We filed an application with the Canadian government, specifically with the Food Directorate, to market the product chitosan. That application was made at the end of 1997.

The clinical study focussed exactly on the questions and concerns the government had. At the time when the subject of the study was determined, we had the letter from the Canadian government clearly stipulating the questions and concerns the government had. Therefore, the study was focussed precisely on answering the questions the government had.

At the end of 1997, we tabled our report, confident that we would obtain a speedy response which, once all bans on the product were removed, would allow us to market it. However, the people examining the said document, perhaps for reasons of incompetence or because they didn't take the necessary time to correctly examine the issues, determined that there were two shortcomings.

• 1520

In fact, there were no such shortcomings. The doctors and researchers working on this project—and it wasn't me who responded—responded to the two objections raised by the government. With this response to the two objections, we filed our application once again and we are still waiting for the government answer.

Waiting is one thing. It's a different matter when you are just a small company made up of hard-working people, who are doing their utmost to ensure that a product they intend to market is effective and poses no health risks. The worst thing about all this is that among the host of products available to combat the production of cholesterol through the organism, ours is probably the most effective.

In the present context, not only is it absurd that we are still waiting for the response, but it is even more ridiculous that we have to wait while knowing that we could be marketing a product which would help people to reduce their cholesterol rate without any side effects since it is not absorbed... The process involved here is a binding action: cholesterol is bound to the chitosan and eliminated naturally without anything being absorbed.

Therefore, because of current legislation in Canada, we will be marketing—I hope that you will take this into consideration—a product to reduce cholesterol, but on which we will have no right to mention cholesterol. The labelling of the product will indicate a recommended dosage. There will not be any warning since there is no danger, and people will have to guess by looking at the product, its colour, the shape of the bottle or something else, that in front of them is probably the most important product currently on the market. In fact, 40% of people suffer to some degree from excess of cholesterol. They will just have to guess that this is a cheap, effective and absolutely safe product.

I would point out to you that this product is effective and also that it has been tested on people who were not on a diet. Therefore, it is not a drug. It is a food supplement. People don't have to give up anything. They can eat normally, and the product still works and has no side effects.

The system is absurd and really unacceptable, both to the general public and for those people involved in developing new products, in helping to improve the health of Canadians and offering quality and effective products. To show just how absurd it is, I will point out to you that one day we will probably receive authorization to market this product as a food. The product will then make no claim, and the labelling will be anonymous.

However, after all the money we have invested, we cannot just accept such a situation. We have to be able to advertize it and recover the money invested in order to continue the work we have begun on other products which are just as valuable as the one we are talking about.

Therefore we will apply to the government for a DIN. At the same time we will ask for exclusive rights of claim over the product, so that we can retain for some time our technological lead and recover the money invested, which is completely to be expected.

[English]

The Chair: Can you finish up quickly so the others can have a say, please?

[Translation]

Mr. André Aubé: Throughout this whole process, the most absurd thing is that the current regulations of Health Canada will almost certainly prevent us from obtaining the DIN, and as a result we will just have to put the product on the shelves as a food, without any other claim.

In conclusion, I would say that $30,000 and 24 months later we are back to square one. I don't think you would agree with such a situation. I don't. To put it politely, I am very frustrated and I hope that this kind of situation will not be allowed to recur. I hope that people will be able to obtain medication when they need it, and all necessary information will be indicated on the label.

I did not mention this earlier, but I am the president of a small company. I hope that one day it will become a very large company. I will do things seriously, because I know what I'm talking about. I am a pharmacist and I have been involved in manufacturing natural products for years.

Thank you for taking the time to listen to my views. I hope that what I told you will help you to make the right decision.

• 1525

The Chair: Mr. André Lavallée.

Mr. André Lavallée (National Health Products Association; Executive Director, Le Naturiste JMB Inc.): Thank you, Madam Chair, good afternoon, ladies and gentlemen.

My presentation today will be brief. I submitted a document to the clerk. Before dealing with this, I would just point out that the business I represent is a retail business. It is probably one of the largest ones in Quebec, if not in Canada, in the area of natural food or natural products.

To give you an overview of our situation, we have 150 retail locations, primarily in Quebec; there are four locations in New Brunswick and just one in Ontario. We have approximately 500 employees working in the natural products retail sector, which puts us in quite a strong position, as we are very close to Canadian and Quebec consumers of these products.

I'd like to talk to you today most specifically about an article which appeared in Le Journal de Montréal. The article was written by the person who founded our company, the natural product expert Jean-Marc Brunet, and he gives his views on the subject your committee is dealing with. I will not read it in full, as you can do that yourselves. If I may, I would just read a few extracts from it. It will not take very long.

Basically, what we want as retailers is parity or a situation similar to that which exists in the United States. I would just like to read you one extract from the article.

In the area of herbal medicine, it is essential to achieve as soon as possible a situation similar to that in the United States. It is absolutely essential that we achieve parity with the Americans.

In the United States, it is possible to market herbal medicines and attribute to them therapeutic qualities so long as research shows their effectiveness. In Canada, the marketing of such plants is subject to enormous complications, as is the case with synthetic drugs which have unfortunate side effects, counter-indications and definite toxicity.

Medicinal plants used by naturists are not at all toxic. They do not have any side effects or counter-indications. They are effective, however, as has been shown by a great deal of research.

In the United States these facts are recognized and the marketing of such plants is permitted. As there is free trade between Canada and the United States, obviously such plants can be obtained from our neighbours to the South. This means that individuals wishing to market medicinal plants in Canada are disadvantaged.

The right of the consumer to choose the medication he or she wishes is also violated. In a democratic society, it is essential that such a choice be possible.

Unrestricted marketing should be allowed for non-toxic substances, whether they are a food, plant or other product, displaying properties considered useful (nutritional, preventive or therapeutic). There is no reason for such substances to be judged by the same standards as toxic drugs.

It is precisely the concept of toxicity which should constantly prevail. Non-toxic substances which have shown their effectiveness, should not be subject to the same standards as toxic substances. Since they are safe, no restrictions should be imposed on them.

I will limit my presentation to the reading of this article, to the expression of this position. I would just point out that Dr. Jean-Marc Brunet founded this company 30 years ago. So the company has been in business for 30 years. I would also point out that the column from which I just read an extract is never used for marketing purposes. It never refers to products or trademarks marketed only by us. In this column which appears every day, there are never any indications of a commercial nature.

Thank you very much, ladies and gentlemen.

The Chair: Thank you very much.

Mr. Roger St-Laurent.

Mr. Roger St-Laurent (National Health Products Association; President, Laboratoire du St-Laurent E.H. Ltée): Madam Chair, ladies and gentlemen, I would first like to provide you with some brief background information. I am a chemist by training. I have been working in the manufacturing of pharmaceutical and natural products for just over 25 years. I set up a new company a few months ago. We want to specialize in the extraction of plants; our aim is to identify the active properties of plants.

• 1530

I heard someone say that often we don't know what is in the products being sold on the market. I would point out that is not because the laboratories are unwilling to indicate the ingredients used, but rather because the labelling standards imposed by the Canadian government prevent us from doing so. Once you make a claim regarding an ingredient, it becomes a drug, and when that happens, as my colleague Mr. Aubé pointed out earlier, there are enormous costs involved and in 99.9% of cases the product is refused.

I would like to talk to you about the enhanced use of nutraceutics in Canada. The main issue is as follows: we want to bring about harmonization, through free trade or other regulations, with the United States and Europe, but the trend in Canada is to do things which work against harmonization.

One hundred kilometres from Montreal, people can obtain herbs which are illegal in Canada, for example comfrey, to which reference was made earlier. Why, 100 kilometres from Montreal, can people in the United States have cartinine in amino acids and also arginine? Why can we not talk about an antioxidant product in Canada when referring simply to vitamin E, vitamin C or beta-carotene, whereas the Americans can do so? Why can they have chitosan in their sliming products? Who doesn't know someone who cross the border to buy melatonin?

I would just like to point out to you that this makes the Americans smile. I was on the east coast last weekend. They wonder why we cannot get melatonin, why we cannot get certain herbs, whereas they can freely purchase codeine and aspirin over the counter, in the form of our 222s which the Americans snap up. Why can we buy codeine over the counter, whereas we can't buy natural products or plants? Americans smile when they see this, and I think they're right.

In summary, I think that we are violating the rights of Canadians by preventing them from purchasing what they want, and in so doing we are hurting the Canadian economy. We cannot manufacture, distribute or sell products which we could easily sell to other countries. Perhaps we would be able to help our health system, which is in a bad way. We are trying to reduce costs everywhere. If patients were given a free choice about using natural products, the costs of the medical system would not increase. It might perhaps decrease because there would be a drop in the consumption of pharmaceutical products, which we know to be toxic.

People are being obliged to import products privately or try and obtain them more or less legally. As our customs controls are quite inadequate, it is far mor difficult to export products in the United States than to import them from the U.S.. Is the border wider on our side than on the other? I wonder.

I know that we have tried to send to the United States empty samples of vials to be taken orally, and that they wanted to check the air in the vials in case it was toxic. However, I can tell you that it is possible to bring into Canada U.S. products, such as melatonin, in quantities of 144 bottles although this product is illegal in Canada.

[English]

The Chair: Thank you very much.

Madame Caplan, do you have a question?

Ms. Elinor Caplan: Yes, thank you.

We've heard many stories such as the two from Madame Poirier and Monsieur Aubé. The point we've heard from many people is that there's a need within Health Canada to have greater expertise available for an understanding of natural products and natural therapeutic products. I'm assuming you would agree with that statement.

Also, we've heard people say, as you did, madame, that they fear publicly pointing out the anomalies. I regret that people feel that way. Certainly that message has been heard by this committee and I know it will be heard as well by Health Canada.

The question I have is for Mr. Aubé. Initially you said that the product you referred to was for weight loss. Does it still work for weight loss, or is it just because there's evidence now that it's good for cholesterol reduction that you've changed your application? I was curious, because you switched from weight loss to a cholesterol reduction formula and I wasn't sure why.

• 1535

[Translation]

Mr. André Aubé: In the United States, the product is marketed exclusively to help people lose weight. Before us, nobody conducted a study to show its effectiveness in combatting cholesterol. We are the first company to have conducted an exhaustive study showing not only that it is safe, but also that it is effective for cholesterol. In the United States, no such work has been done and no one said through a claim on the bottle that the product could be used to control cholesterol. Therefore, they focussed on the weight loss aspect.

[English]

Ms. Elinor Caplan: Do you recommend a caution that this may produce weight loss?

[Translation]

Mr. André Aubé: No. Studies have shown that it was not very effective for weight loss. It is effective for cholesterol.

[English]

Ms. Elinor Caplan: But you're saying that in the United States it's widely marketed for weight loss.

[Translation]

Mr. André Aubé: Yes. In the United States, it was marketed exclusively for weight loss.

[English]

Ms. Elinor Caplan: Does that suggest a problem?

[Translation]

Mr. André Aubé: No, that is not a problem. At one point, research was carried out at the University of Sherbrooke in Quebec to determine the impact of chitosan on cholesterol. That was the direction we followed in our work.

[English]

Ms. Elinor Caplan: At the beginning of your presentation, I was under the impression you thought it should be available in Canada for weight loss.

[Translation]

Mr. André Aubé: It was offered to the Canadian public for weight loss as early as 1995. It was then that the Canadian government intervened. It intervened not because it agreed or disagreed with the claim regarding weight loss, but rather because there was no proof that the product was safe. The safety of the product was not demonstrated, regardless of the reason why it was to be distributed.

[English]

Ms. Elinor Caplan: So let me understand the situation today. The situation today is it's safe; it's not effective for weight loss, but it is effective for cholesterol reduction; and it is available in the United States for weight loss.

[Translation]

Mr. André Aubé: That's right, and that is also available in Canada for weight loss. While we do not have the right to distribute it—

[English]

Ms. Elinor Caplan: I understand.

[Translation]

Mr. André Aubé: —it is on the shelves already. This was taken in Toronto. On the Internet, there are 40 sites where you can purchase chitosan.

[English]

Ms. Elinor Caplan: So it's available in Canada for weight loss, but it is not effective for weight loss. But it's safe; it won't hurt you.

[Translation]

Mr. André Aubé: I am stating that on the basis of studies conducted, it was determined that it was not very effective for weight loss. But that is not the problem. The problem is that it is on the Canadian market as I am talking to you now. Without any claim since people do not have the right to make any such claims. It is being promoted, by indirect means, as a product to help people lose weight. My company does not want to market the product as a way of helping people to lose weight. It is not very effective in that regard. We want to market it for cholesterol, and in this regard it is very effective. We have shown that it is safe.

[English]

Ms. Elinor Caplan: On the issue of exclusivity, I'm assuming you have patent protection. You've applied for a patent and—

[Translation]

Mr. André Aubé: Not for chitosan as such. The research is continuing. The research will take place over a three-year period. We will produce a derivative from chitosan, on which we will have a patent, but for the moment chitosan is available to anyone wishing to buy it. Anyone can buy chitosan.

[English]

Ms. Elinor Caplan: My question is, what kind of exclusivity would you suggest be given to you?

[Translation]

Mr. André Aubé: Exclusivity of claim. We are the only people who did the research to show that it is effective in controlling cholesterol, and for a certain time period we would like to be the only people allowed to claim on the bottle that the product is effective in controlling cholesterol. I am not the one inventing the method—

[English]

Ms. Elinor Caplan: What about the weight loss?

[Translation]

Mr. André Aubé: Weight loss? If someone else shows that it is effective for weight loss, he or she will do so and ask for exclusivity. But you have to produce the evidence showing that it is effective.

[English]

Ms. Elinor Caplan: Is there any method other than patent protection that would give you exclusivity for claim?

[Translation]

Mr. André Aubé: That's possible, but this has already been discussed in Canada. This is being done already in other countries.

[English]

Ms. Elinor Caplan: Is it available today?

[Translation]

Mr. André Aubé: That is being done in other countries where, for a given time, exclusivity of claim is granted to enable the company which conducted the research, which had the courage and honesty to do the necessary research, to recover some of the money invested, so that it can subsequently be invested in something else.

[English]

Ms. Elinor Caplan: But it's not available in Canada today on the basis of claim?

[Translation]

Mr. André Aubé: No.

[English]

Ms. Elinor Caplan: Thank you very much.

I want to make sure I understood Mr. St-Laurent. I'm not sure if it was a problem with translation.

Are you saying that codeine, 222s, are available in the United States without prescription?

Mr. André Aubé: They're available in Canada without prescription.

Ms. Elinor Caplan: But not in the United States?

Mr. André Aubé: Not in the United States.

Ms. Elinor Caplan: In the United States, they require a prescription?

• 1540

Mr. Roger St-Laurent: Yes, and what we call 222s, which have a low dosage of codeine, are available at the counter.

Ms. Elinor Caplan: Behind the counter.

Mr. Roger St-Laurent: It's behind the counter, but if you ask the pharmacist he will give it to you. He doesn't need a prescription from you.

Ms. Elinor Caplan: That's right. So the point was that there are differences between Canada and the United States.

Mr. Roger St-Laurent: We're very tough on herbal products and we are smooth on codeine.

Ms. Elinor Caplan: And they're tough on codeine and—

Mr. Roger St-Laurent: They are crazy on codeine.

Ms. Elinor Caplan: But you can make claims on products and Mr. Aubé says there is no evidence to suggest there's a claim.

Mr. Roger St-Laurent: Exactly, yes.

Ms. Elinor Caplan: So I would suggest that there are problems on both sides of the border. Would you agree with that statement?

Mr. Roger St-Laurent: I agree with you.

Ms. Elinor Caplan: I think they call it DSHEA. That's the model in the United States for regulation of non-prescription products, natural and herbal products. There are some problems with that method as well.

Thank you.

Mr. Roger St-Laurent: May I just answer your other question? You said something at the beginning to Mr. Aubé. You said there is not enough Canadian expertise, that there is inadequate Canadian expertise.

Ms. Elinor Caplan: Within Health Canada.

Mr. Roger St-Laurent: I used to be the president of the ANPS, the association we represent today. A few years ago at a meeting we suggested that they use the expertise that exists in the U.K., France and Germany, to use the pharmacopoeia that they are using. They refused to use it because they said they needed experts from their department, their government, to do the job. And within the last five to ten years, they did two pharmacopoeia on herbal products. And honestly, between us, they want to save their jobs. That's the problem.

Ms. Elinor Caplan: Thank you very much.

The Chair: Thank you.

I have a question for Mr. Aubé. We're not meaning to pick on you, but in the States could you sell your product for reducing cholesterol?

[Translation]

Mr. André Aubé: Yes.

[English]

The Chair: But you don't. You just sell it for weight loss.

Mr. André Aubé: No.

The Chair: You're selling it for both down there?

[Translation]

Mr. André Aubé: No. We haven't begun to sell it in the United States. We will begin in the next few weeks. It will be sold as a product to control cholesterol, and it will be very clearly indicated on the bottle that it reduces the level of cholesterol or maintains a healthy cholesterol level.

[English]

The Chair: In the States you don't have to have any proof to sell it for weight loss. Do you need to have proof that it would be good for lowering cholesterol?

[Translation]

Mr. André Aubé: With current U.S. legislation, whether you market the product to reduce weight or to control cholesterol, you need proof showing that your product really does what you claim for it. That is already required under U.S. legislation.

[English]

The Chair: Do you mean to tell us that you didn't have...? Oh, it's just that you personally believe that product is not good for weight loss?

[Translation]

Mr. André Aubé: That's right.

[English]

The Chair: But you sell it in the States for—

[Translation]

Mr. André Aubé: We haven't yet begun to sell it. We'll begin to sell it in the next few weeks as a product for cholesterol. We are not selling that product, either to control cholesterol or help with weight loss. We do not want to market it for weight loss, but rather as a way to control cholesterol, as it is effective in that regard.

[English]

The Chair: Is somebody else selling it in the States?

[Translation]

Mr. André Aubé: Not for cholesterol because we are the first to—

[English]

The Chair: Is somebody else selling your product for weight loss?

[Translation]

Mr. André Aubé: Yes. The product I am talking about comes from shrimp or lobster shells. It is a natural product and can be purchased by anyone. Other companies sell chitosan. It is sold in the United States for weight loss.

[English]

The Chair: I have some other questions, but this is just going in circles.

Ms. Elinor Caplan: Just to clarify this, in the United States it would have a disclaimer that says the FDA has not proven the effectiveness for weight loss or for anything else.

[Translation]

Mr. André Aubé: Under the current American legislation, you have to put that disclaimer on all natural products. It's mandatory. You have to put it on. It's in the legislation.

[English]

Ms. Elinor Caplan: And if you wanted to sell it for cholesterol reduction, you'd need to have the same disclaimer on it—

[Translation]

Mr. André Aubé: Same thing, Madam.

[English]

Ms. Elinor Caplan: —and you'd have no exclusivity.

[Translation]

Mr. André Aubé: No.

[English]

Ms. Elinor Caplan: Thank you.

The Chair: Would you like it if we had that same disclaimer in Canada? Would you be able to sell your product now?

[Translation]

Mr. André Aubé: Perhaps in some cases, but I don't think we should follow the Americans' example exactly in this particular case. If a company does have evidence that the product is effective and the testing has been done, I don't see why you would include a disclaimer saying the contrary. You would have to put it on most products, but in other very specific cases, including the one that I've just explained to you, we certainly don't need a disclaimer when the clinical studies have been done, the same ones that are used for so-called conventional medicine.

• 1545

[English]

The Chair: But if you hadn't done your studies yet, if we had a disclaimer, you could be able to sell your product here without spending all this money you're talking about on your tests.

[Translation]

Mr. André Aubé: I can't sell it as a natural food either without putting anything at all on the bottle. I am not allowed to sell it at all. Chitosan cannot be sold in Canada as a food or as a medication. It is completely forbidden. These companies are selling it illegally.

[English]

The Chair: I realize that, if we had disclaimers. I'm talking about—

[Translation]

Mr. André Aubé: If we ever had a disclaimer? Yes, certainly. But even so, I would want some safety checks done, because the disclaimer doesn't make the product safe. It says that the FDA hasn't checked what you are saying. That doesn't mean that the product is safe.

The American legislation contains some good things, but a few small changes could be made. Furthermore, if the government wanted to get some good ideas, it could perhaps ask us for our opinions, because we have been working in this area for years, Roger and I, and others. We know exactly what the government should do so that the people will be safe and will have access to these medications.

[English]

The Chair: Would you please send that to us? That's why we're here, to ask you what these ideas are. We know what the problems are; we want the ideas. If you could send them to us, we have to go on with some other questions now.

[Translation]

Mr. André Aubé: The association that I belong to, which is called the NHPA—National Health Products Association—already sent you a report three weeks or a month ago. It contained everything you need for a serious, long-term solution.

[English]

The Chair: That's fine.

Madame Picard.

[Translation]

Ms. Pauline Picard: I would like us to get back to Health Canada. You submitted your product to Health Canada, saying that it was an innovative product, and you asked that it be approved.

Mr. André Aubé: At first as a food supplement.

Ms. Pauline Picard: Was it for weight loss at that time?

Mr. André Aubé: No, not at all. Forget about weight loss. That has nothing to do with me.

Ms. Pauline Picard: Fine.

Mr. André Aubé: I'm Mr. Cholesterol.

Ms. Pauline Picard: Great, Mr. Cholesterol. So, you submitted it as a food that could reduce cholesterol.

Mr. André Aubé: That's right.

Ms. Pauline Picard: And you were turned down?

Mr. André Aubé: It was submitted, supported by the study that I was telling you about a few moments ago, and they got back to us, saying that two points needed to be cleared up. They were cleared up, but we still don't have the approval.

Ms. Pauline Picard: You don't have the approval?

Mr. André Aubé: No.

Ms. Pauline Picard: They asked you about two points and they...

Mr. André Aubé: I should point out that the two points...

Ms. Pauline Picard: Normally, if your product is in the food category, you don't need a DIN to market it.

Mr. André Aubé: No, but chitosan is prohibited in Canada, as a food and as a medication. We were not allowed to distribute chitosan because its safety hadn't been demonstrated until we did our study.

Ms. Pauline Picard: After the study, they turned you down...

Mr. André Aubé: We haven't been turned down. We're waiting right now.

Ms. Pauline Picard: How long have you been waiting for?

Mr. André Aubé: For about four months.

Ms. Pauline Picard: Thank you, sir. We understand your frustration. This isn't the first time that we've heard about this. We've met with Lord knows how many witnesses throughout Canada since December. We have heard other stories like yours, but I'm still always surprised when I hear such things. I can't believe it's true. Who makes the decision, who does the analyses and why? We're told one thing, but no one knows why. Why is something prohibited? Why is melatonin prohibited, for example? We don't know why.

Mr. André Aubé: Pardon me, Ms. Picard, but could I just take 30 seconds to explain one of the objections to you?

The government objected because when you first look at the study, it would appear that the product decreases vitamin D levels. That was one of the government's two objections.

Well, believe or not, in Quebec, actually, in the entire Northern hemisphere, vitamin D levels drop by 50 per cent during the winter, for everyone. When there is no sun, people don't get much sunlight and their vitamin D levels drop. The vitamin levels had dropped by 30 per cent because the study ended in December. If it had continued until February, vitamin D levels would have dropped by 50 per cent, just as they do for everyone. When the people stopped taking chitosan, their vitamin D levels did not rise, because there wasn't any sun.

That means that the people who reviewed our files are incompetent. It's as simple as that. Not only are they not interested, they're also incompetent. I don't think I'm being impolite when I say that.

• 1550

Ms. Pauline Picard: Thank you.

Mr. Lavallée, every day I read Mr. Jean-Marc Brunet's column and I certainly do enjoy it. Is the founder of your company in favour of a third category for natural products?

Mr. André Lavallée: Are you talking about a category other than food and drugs?

Ms. Pauline Picard: Yes.

Mr. André Lavallée: The founder's position has always been that our products are not drugs as such. Nor are they foods. So, having a third category would be an interesting approach.

One thing is for sure, we don't think that natural products are drugs. We are not selling drugs. Over the years, we have been strongly opposed to marketing products with DINs, except for very specific products such as vitamins, for example. We are very much opposed to marketing products with a DIN, which means that the current regulations keep us from saying anything about our products. If they aren't drugs, they're foods. I'm sure you're familiar with this dilemma.

Things are getting tougher and tougher, particularly since the world of natural products is becoming increasingly democratic. We are up against competitors who tend to make statements that go beyond what is allowed under the current legislation. I think we're ready for a change in that area.

Ms. Pauline Picard: Thank you sir. Thank you, madam.

[English]

The Chair: Ms. Caplan.

Ms. Elinor Caplan: I have two questions for Mr. Lavallée.

First, given the discussion and the debate you've heard from this panel, would you still hold the position that we should harmonize our policy with that of the United States?

[Translation]

Mr. André Lavallée: Yes, I think that we should have something that's relatively similar. If our policy is too different, strictly from an economic point of view, sooner or later we'll have problems.

[English]

Ms. Elinor Caplan: Even if there are problems that they're experiencing? Maybe they should adopt our system.

[Translation]

Mr. André Lavallée: Frankly, I do not think that it would necessarily be desirable.

[English]

Ms. Elinor Caplan: The second question is about the statement you made that herbal remedies are non-toxic, without side effects or contraindications, and yet we've heard from other witnesses that sometimes herbal products should not be used by pregnant women or people with high blood pressure. Do you believe there's a role for Health Canada in ensuring that products are safe and insisting on warnings where there are contraindications?

[Translation]

Mr. André Lavallée: Yes. Some products may be more toxic than others. I agree with you that we should be cautious in some circumstances. That is already being done.

On the other hand, the vast majority of products sold in our business are entirely safe. I know what I am talking about and there is scientific evidence in that regard.

As I said earlier, within our business we have 30 years of experience. During these 30 years of selling natural products, as far as I know, we have never had any problems of this kind.

However, we should be cautious regarding some products, but not all of them. The vast majority of them have no toxic effect.

[English]

Ms. Elinor Caplan: I'm assuming you're aware of the draft report of the Advisory Panel on Natural Health Products.

[Translation]

Mr. André Lavallée: Yes.

[English]

Ms. Elinor Caplan: They have recommended a cascading approach on the basis of risk management, with more strict regulation for high-risk products. Would you agree with that approach?

[Translation]

Mr. André Lavallée: Yes.

[English]

Ms. Elinor Caplan: Thank you. That's it.

[Translation]

The Chair: Thank you very much.

Mr. André Lavallée: You're welcome.

• 1554

• 1557

[English]

The Chair: Lise, would you like to start?

[Translation]

Ms. Lise Lefebvre (National Health Products Association; Director, Yves Ponroy Canada Inc.): Good afternoon, Madam Chair, ladies and gentlemen. I will summarize the brief that has been distributed.

I am the Director of the Yves Ponroy Canada Inc. Biological Research Institute, founded in 1991. The Institute was established in Europe in 1979. Yves Ponroy is a great pioneer. He is a leader in the nutritional supplements market. He's a biochemist and has a PHd in science.

I will not mention the problems we had with a line of products call Leritone and will deal with the facts.

Regarding Nutricap, we had a problem with the HPB that visited our offices in February and asked us to stop selling our Nutricap product. I brought with me boxes that came from various countries throughout the world, from Belgium, Russia and Greece, and they all had a label stating that that product is essentially used to make nails and hair healthy and strong.

In 1994, The Ponroy Institute did a clinical study that was published in Les Nouvelles Dermatologiques in Europe and that proved the product brought about an improvement in nails and hair. That study was published. I will leave a copy with you. As you can read on the boxes, the only mention is "nutritional supplement" and that box was approved by the HPB. I personally think that it is unacceptable to sell a product that doesn't have any additional specifications.

After the visit of the Health Protection Branch's officials, we obviously stopped selling the product. We put all the boxes back in their packages and threw away everything we had, namely 30,000 boxes. It cost us about $15,000, plus expenses and lost sales for that product during the month of February.

• 1600

Let me tell you that, for us, it was a second disaster in February, just following the January ice storm. We therefore erased everything on the boxes but "nutritional supplement". However you can see that on boxes coming from every other country in the world it is said that the product is used to make nails and hair healthier and stronger.

It is in my view unacceptable that we cannot use results in Canada from clinical studies done in Europe by a serious business like Yves Ponroy before marketing a product. And that is only one example! I have six or seven more,, if you're interested.

We have a whole line of products for which there were clinical studies and we even recently invested $150,000 for clinical studies in co-operation with the UQAM. A scientific clinical study was done for another product, but again, we can barely use the results. It appears that we are not allowed to say that a clinical study was done and that results show the quality of life of older people is improved, or that there is less depression or that it helps people sleep better.

I will leave it to you to think about all the examples I mentioned. Thank you.

The Chair: Thank you very much.

Qui sont les suivants?

Mr. Guy Bohémier (National Health Products Association; Naturopath and Consultant): My name is Guy Bohémier. I am the President of the Société ÉducoSanté, which has a group of practitioners working in the area of prevention. I am also the Vice-President of the Quebec College of Naturopaths, which is the oldest naturopathic organization in Quebec. It was founded in 1963. I have often been called on by industry as a consultant. I have dealt with government officials on several occasions, and, of course, I have dealt with all the problems we are discussing here today.

Our interest in the area of natural products is quite clear. These products must be available on the market if we are to recommend them to our patients and clients.

I would like to start by mentioning that there must be some regulation of natural products. There is a possibility that unscrupulous individuals could try to market as natural products, products that might not meet some very specific criteria. Consequently, regulations are necessary.

The problem with regulations is that our products have always been identified as drugs, and the same regulations have applied to them as are applied to drugs. That raises a whole series of problems throughout Canada. I'm sure you already heard about them.

People often seem to think that drug regulations are ideal, extremely safe, and enable us to meet the criteria of both safety and effectiveness.

In that regard, I think some clarification is required, because, in our view, that is not exactly what really happens. I understand that classic drugs are prescription pharmaceuticals in most cases, and I think we should also include over-the-counter drugs, because these substances are almost always somewhat toxic and somewhat dangerous.

It was recently reported on television and on radio that a study done in the United States by a professor from the University of Toronto showed that adverse drug reactions are the fourth largest cause of death.

So, despite these stringent, serious, very tight regulations on drugs, that some want to apply to us and that are applied to us for natural products, which are far less toxic, drugs are hardly safe.

• 1605

There are two main points regarding natural health products. They must be safe, they must not be dangerous. Our products must not be toxic. I think that is the first point. We work in the area of healthcare products, and our intention is certainly not to poison people or to expose them to any risks by using our products. So the first criterion is that our products be safe.

The second criterion, is that they must be effective as well. If our products are safe but don't work, it is not worth marketing them. And it is certainly not worthwhile for consumers to use them.

With respect to the first criterion, the non-toxicity of our products, this fact must be proven. There are different ways of proving and determining that our products are not toxic. We can use existing studies. Generally, in the area of natural products, we proceed cautiously, and before marketing a product, we must wait until its safety has been proven. So studies can prove the safety of our products.

We may also consult existing monographs which state whether a particular product has any level of toxicity. If the monograph states that the product has no toxicity at all, that is something else on which we can base our assertion that the product is not dangerous and can therefore be marketed.

To some extent, we also want to base our decision—and I believe this has been done—on past experience. If people have been using a product for decades and longer without ever having any problems, then we may conclude that the product is safe.

We may use the same sources to prove the effectiveness of a product. Research will tell us whether a product is effective. Government officials often rely on traditional practice to some extent. If a product has always been recommended and always been used for a particular purpose, we may assume some degree of effectiveness. Product monographs also give us some idea about the effectiveness of a product. This should be adequate to determine whether or not a product works.

In our view, overstated standards are often applied to measure effectiveness. For example, there is a concept known as "significant scientific agreement", which means that 50% of the scientific community or the experts who comment agree about the product's effectiveness. I don't think we can rely on this concept, because there are many invalid reasons that could explain why more than 50% of the scientific community disagrees. People may oppose an idea or the results of research without any real justification because of their arrogance, their lack of openness, their preconceived ideas and perhaps also their intellectual sloth.

Many examples have already been mentioned. Perhaps one of the most telling involves an English doctor, Dr. Lynd, who discovered that English sailors suffering from scurvy could be cured if they consumed enough lime juice. When Dr. Lynd put his theory forward, the scientific community ridiculed it. He was considered crazy, because it was thought that scurvy was much too serious a disease to be treated with such an ordinary product as lime juice.

• 1610

Dr. Lynd's claim that lime juice could be used to prevent scurvy was only applied 40 years later, simply because, at the time, there was no significant scientific agreement. For 40 years, sailors continued to die of scurvy. How many people died because of the arrogance of the people in authority? Rather than checking whether or not Dr. Lynd had discovered something valuable, they continued to stupidly deny his claim.

Research is valid if it demonstrates something, and not just because everyone agrees with it. The value of any research is determined, quite simply, by its intrinsic qualities and accuracy. If we are dealing with research that has been properly done and leads to scientific results, I think that we can and must consider it without having to seek the agreement of 50% of the scientific community. In fact, that is quite difficult to get, because many officials have all sorts of reservations about new ideas, and could be quite fierce in their opposition to them.

I come now to what may be a solution to the problem we are all facing. I don't think the legislation must necessarily be changed if some substances, known as food supplements, have some therapeutic merit, which can be demonstrated easily and has been demonstrated in the research. I think they may be considered drugs according to the definition of drugs. However, if the substances are not toxic and if they are effective as well, we do not need to have them go through the same process as synthetic substances, which, generally speaking, are highly toxic.

If the government were to agree to the creation of a committee of experts suggested by the industry, the government could retain the right to veto certain suggestions. The fact is, the government finds it very difficult to abandon its right to administer certain things, which is quite reasonable in this case, because it is responsible for protecting public health. The committee would be chiefly advisory in nature, but before a decision was made about approving a product, the government would have to at least listen to the committee of experts.

In the case of non-toxic products, that is products whose toxicity has not been proven, some claims could be made and would normally not cause any problem. There can be structure-function claims, for example, in the case of a product that would promote regularity. There's no mention of a disease as such; there's just a reference to a structure or a function that works better if a particular substance is taken. The claims may also be about risk reduction, and, in this case, do not really present a problem. We could also add disease-prevention-type claims. An individual who is not sick, but wants to prevent a disease, is not in a critical situation.

The concept of treatment may be somewhat more difficult, but the first three claims, of structure-function, risk reduction and disease prevention, could be handled relatively easily. The following approach could be used: the industry would market the product and, after a relatively short period of time, perhaps one or two months, would notify the government that the product had been marketed, and the government could then decide whether the product could stay in the market without any risk to public health.

• 1615

The government should make specific claims regarding the structure-function, risk reduction or disease prevention. If the government thinks there could be problems, it would have to consult its advisory committee of experts, which would express an opinion that the government would consider in making its decision. If we disagree with the government decision because it may be the opposite of the committee's view, we could consider establishing an appeal board, an organization independent of both industry and government, which would be called on to make the final decision.

I think the very fact that the committee of experts has considered the matter and expressed an opinion should have some influence on decisions made by government officials, particularly since the committee's view could be made public, and we could imagine the consequences that would have. This might prevent government officials from making unjustified decisions. There must really be some very serious reasons for rejecting the findings of the committee of experts.

With a structure of this type, we would probably be able to solve the problems facing the industry, about which I am sure you have heard during your proceedings. Many people appeared before the committee to complain about various things they think should not happen. I think they are right to complain, and that is probably one of the reasons why you decided that the Standing Committee on Health would study natural products, following the decision made by the Minister of Health.

This may be a partial solution to the problem, and may finally satisfy everyone. Thank you.

The Chair: Thank you very much.

Mr. Gagnon.

Mr. André Gagnon (President, National Health Products Association; General Vice-President, Santé naturelle (AG) Inc.): Good afternoon, Madam Chair, ladies and gentlemen. My name is André Gagnon. You may remember me, because I presented this paper when I appeared before the committee some time ago. I'm a member of the Advisory Panel on Natural Health Products. I'm also the president of the ANPS. I would ask you to look at the document you all have before you. I'm also the Vice-President of Santé naturelle, a company which manufactures natural products and is better known by the name Produits André Gagnon.

On Thursday and Friday of last week, I was in Ottawa for the last meeting of the Advisory Panel on Natural Health Products. It was a most interesting meeting. We talked about a lot of ideas and questioned many things. I should say at the outset that we found the report by the researchers very useful. It is unfortunate that the panel did not officially receive the researcher's report. Without it, it would have been difficult to do a serious job.

All the members of the Advisory Panel were very pleased that I was able to give them the researchers' report, which raises some very direct questions. I would therefore like to thank the people who gave it to us. The report was very well done and extremely useful to us. I would like to make particular mention of the excellent work done by the researchers on this subject.

I must say that ANPS supports many of the positions that will be taken on this matter by the Advisory Panel. We must try to reach a consensus both in the industry and within the Advisory Panel, which represents a number of stakeholders and communities in Canada.

First of all, we realize that there were many language problems. That is important, because we have to be specific in both languages. For example, there is reference to "risk". I often hear people speaking about "risk", which is very often confused with "safety". We realized that a great deal of work needed to be done to clean up the terminology.

There is also reference to "drug claims" "treatment claims" and "therapeutic claims" and these are terms that are often used interchangeably. There is reference to a third category. When we think about this, we realize that we need to clean up and standardize the use of these terms.

• 1620

In the presentation I will be making in a few moments, I am going to be careful to use the proper words, in their context.

First of all, there are some pretty weird comments being made about the third category. Unfortunately, some of them came from the TPP and were to the effect that a third category would create an additional grey area. Unfortunately, that is playing with words and isn't putting them in their proper context.

At the moment, the Act defines food and drugs. When we are talking about health products, there is no logic in saying that they will be somewhere between food and drugs as defined in the current legislation. Under the Act, a drug is anything, either a food or a health product or anything else. I think it makes sense to set aside the idea that health products fall somewhere between food and drugs, and this was the basis on which we made our recommendations.

I must say too that I have heard many of the briefs that have been presented to you. You heard some comments from the ultra- conservative conventional doctor, with the TPP, who said that this was not so terrible, and from pharmacists, who want to have a share in this growth market and bring forward false arguments about professionalism and other factors. I will just point out that my company sells products in drugstores. However, we have to look at things clearly, and determine whether the arguments advanced are really based on a commercial interest, or whether they have any intellectual merit.

You have also heard from very distinct groups whose cultural philosophy assumes a very important dimension. I'm referring to Chinese medicine. I am quite aware of this, because a number of Chinese medicine representatives are on the Advisory Panel.

I am following events in the United States very closely. However, all this information must be filtered, and I think the researchers did an excellent job. Perhaps a little remains to be done before we can draw some good conclusions.

I am now looking at the document that you should have in English and French.

[English]

You have both in English and in French, if you flip it the other way around you will have the English version.

[Translation]

In summary form, there are seven main points in the regulatory framework. Since you have them there, I will probably not go through all of them, but these seven points cover most of the concepts you need to use.

First of all, there is the classification of natural health products and products cover. This finally answers the burning issue as to where to place natural health products.

We suggest that they be placed under the heading "therapeutic products presented in dosage form". This means we would change the way the term "drug" is used in the Act and would replace it with the word "therapeutic". That is very important. In its broad sense, the word "therapeutic" would include the idea of health maintenance and promotion. This is very important from a technical point of view.

I may be speaking more to the researchers here, because the definition of "drug" in the Act does not include the concept of health maintenance and promotion at the moment. So if we replace the word "drug" with the word "therapeutic" and add a reference to health maintenance and promotion to the definition of "drug", we would cover the use of natural health products.

Thus, under therapeutic products, we would have natural health products and synthetic pharmaceuticals. Why would we do that? The reason is that at some point we have to look at what things are like in real life.

People eat to get the nutrition they require, take drugs prescribed by doctors, or use an alternative, such as natural health products. So we have to devise a plan on that basis. In the end, this classification was drawn up by the Advisory Panel because of the way things really are in life.

Thus, we are not talking about a new category between food and drugs. I hope that is clear. It makes no sense to use the word "drug" in a discussion context, because at the moment, the word "drug" covers anything at all. We are therefore not talking about a third category. We are simply talking about putting things in their proper place.

I will now talk about the risk assessment model. I believe Ms. Caplan referred to it earlier. Here again there is a great deal of confusion between the words "risk" and "safety". We have provided a very simple summary to put an end to the confusion.

• 1625

There is the issue of a product's toxicity and there are certain claims. I believe Mr. Bohémier explained the concept of toxicity quite well.

As regards claims, I could take a product with a low toxicity, and which is therefore safe. When does it become risky?

[English]

When does this product become risky for health—not dangerous but risky?

[Translation]

It becomes risky when the product makes an unjustified claim regarding a major health problem, a treatment claim.

I would like to give an example, but I don't want to take one that is too drastic. We always hear about cancer, so I will use cancer as an example anyway. It is an easy one. If we say that a particular product can help treat colon cancer, and that is not true, the product will nevertheless be a risk to the user, even if it is safe.

[English]

Perhaps I can say this one in English, because it's crucial. This product can be safe but can still present a risk if the product is not effective for what it claims to do.

[Translation]

This is a very important distinction, and I think it puts an end to the debate about the use of these terms. At least that is my view. That was the conclusion we reached within the Panel, in any case. I must say that most natural health products on the market have a low toxicity. That is acknowledged, and experience has demonstrated it.

The next issue is the marketing of natural health products. We assume that safety and quality are required. There'll be no arguments about that. Everyone agrees.

As to the methods and models to be used to achieve this, clearly, subcommittees could be established to develop parameters and criteria for determining how to decide whether a product is safe and of good quality.

Health claims are the main component, the most important point. One thing is certain: the panel agrees that there must be post-market notification—in other words a manufacturer informs the regulatory body in writing, within 30 days, that a health product has been put on the market. The notification applies to products for which labelling standards or monographs exist.

[English]

So that's post-market notification for products for which monograph or labelling standards exist.

[Translation]

It is therefore important to recognize the value of existing foreign documentation. I must state strongly that this is not the case at the moment. Until this problem is solved, nothing will change.

Regardless of the regulatory structure we adopt, we will not make much progress if we do not start broadening our horizons and looking at what already exists. A great deal of literature and evidence exist at the moment, and the idea is that an external advisory body would be given the task of studying the monographs and other documentation that exist throughout the world. As the information was considered genuine and justified, it would be added to the Canadian monographs and labelling standards.

Let me give you an example. There are no labelling standards in Canada for glucosamine sulphate. If there were an advisory committee of experts to review foreign studies and decide what is acceptable, we would immediately have a new labelling standard and would avoid being overwhelmed by hundreds and hundreds of applications—all the same, from companies to the regulatory body. That is what happens at the moment.

Currently, anyone who wishes to apply for a DIN must complete an application and send it to the department. The bureaucracy is cumbersome. Certain labelling standards exist. Only a few exist for herbal products.

The other way of marketing a product would be a pre-market assessment.

• 1630

This would apply in the case of products for which the monographs or labelling standards are not official in Canada. Obviously, this was the subject of much debate, because if we say that all claims must be pre-approved if there is no connection to the monographs, we are getting into a major bureaucratic process. There were about 18 people on the Panel, and about 14 of them were present. They were not all in the business. Perhaps five of us were from the industry. Some other individuals, despite their skills, may not be able to assess what it means to have products assessed and set up a bureaucracy to do so.

Curiously, the Panel's guidelines state that "It has to be cost-effective". But we cannot have both—cost-effectiveness and a heavy bureaucratic structure. Consequently, we can consider the possibility of notification for structure-function claims and even risk reduction claims, but I must say that I am referring more to structure-function.

[English]

This is a very important one, because this reflects a bit what the DSHEA system is. What I always hear about DSHEA is, well, there's something to fix in that system. But you have to look at what the problem really is.

I still think for structure function, products that are safe don't need to be preassessed before going to market, because the risk to health is not that big.

[Translation]

Is that clear? If the product is not dangerous, is safe, and there is nevertheless a structure-function claim because the product is not effective, there is no health danger, because no claim is made to the consumer that the product can treat a disease. I would even be prepared to put a disclaimer on a product in Canada, saying that the product is not meant to cure or treat a disease. I would be prepared to do that.

Let's take the case of the prostate. Let's assume that the bristly palmetto enhances the healthy functioning of the prostate. I never told a consumer that this would replace his synthetic drug. I only said it might be useful. That makes the difference. Of course, that may launch a major intellectual debate. Obviously, the safest route is to regulate all claims. Everybody agrees. But this involves costs, delays, and a bureaucracy.

Now that we are on a cost recovery basis and that 75% of the TPP operating budget comes from users, it would be hard to add to an already heavy bureaucratic structure.

First, the industry has no control over costs. I now pay $500 a year just to be allowed to sell vitamin C. With more red tape, I will have no control over costs. They might eventually go up to $1,000. If I have 100 products, I will spend $100,000 just for license fees. This makes no sense. I agree that the best way to ensure protection of the Canadian public would be to systematically assess all claims, with all possible product combinations, but this is unrealistic. A political choice has to be made. Safe products must be allowed to be sold and all claims need not be pre-assessed. This is the political choice to be made.

[English]

Ms. Elinor Caplan: You're recommending a disclaimer where the claim has not been assessed.

Mr. André Gagnon: For treatment claims only, not structure function.

Ms. Elinor Caplan: Can you give me an example?

Mr. André Gagnon: An example? Treatment claim is a good one for prostatitis. A structure function would be that this product helps the good functioning of the prostate. A treatment claim would be that this product will treat benign hypertrophy of the prostate. This is the difference between treatment of the disease and helping a function.

There are two last things—and they're all important, of course.

[Translation]

The regulatory framework: the committee has decided it would not be given to the Food Directorate. There are many reasons for this. Personally, I provided documents explaining the reason the responsibility should not be given to the Directorate. Please refer to Appendix 1 of the brief.

This was written on September 19, 1996. Do you have it before you?

• 1635

[English]

Anyway, it's written on the second page:

@ti26 7.3 Interim Plan—HPB should develop an interim plan for ad hoc evaluation of claims for functional foods and nutraceuticals.

@ti26 7.2 Expert committee—HPB should immediately take the lead in establishing an expert committee...

[Translation]

This was in September 1996. I sat on the Functional Food and Nutraceuticals Committee. Now look at the other report called Review of Health Canada's Policies Concerning the Addition of Vitamins and Minerals to Foods. Do you know how much time they allow themselves to study this? Eighteen months!

On the other page, it is mentioned that the deadline to study the addition of vitamins and minerals to foods is 1999. The starting point, then, is September 1996 and all the way through 1997, 1998, 1999, it will take three to four years to maybe get results. This is unacceptable. You can't operate with that system. I must also say I read the brief from the Food and Consumer Products Manufacturers of Canada.

[English]

I think the Food and Consumer Products Manufacturers of Canada came and gave you testimony. They said there could be only one category of products, just regulate claims. Fine, but when you read the document, there are loopholes. How do you manage those claims? Nothing is said about them. I talked to those people, I questioned them. Well, they don't care, and they don't have an answer.

[Translation]

I don't think we have quite the same interests. The food industry requires other data than health products. I will not bore you with the difference between functional food and neutraceuticals—this could take up two hours. This is why we must avoid this debate. We would rather let the foods do their job. But the system must be fair.

I would have more comments on the appendix. I feel like I'm repeating things that have already been said, but not quite. You often hear in committee comments on differences between Canada and the United States. If I may, I will discuss differences that exist here in Canada. Look at an ad for Oasis juices. I put that in the appendix. It is said that beta carotene is good for vision.

[English]

They can claim that beta carotene is good for vision. That's a food product. Here I have my beta carotene, but I cannot say that. This is in Canada. This is absolute nonsense. So foods were able to get exceptions to make claims that I cannot make for a health product.

Second, look at All-Bran. Everybody knows about All-Bran. They say it's a drug-free way to promote regularity.

[Translation]

We're talking about a food about which you cannot make a health claim because this would make it a drug. How can that be?

[English]

It's probably because of exemption by regulations through section 30.

I asked this question in writing of the food directorate, and they never answered me. This was a month and a half ago. These are the same people who came and harassed me about my glucosamine sulphate. I cannot tolerate that.

Finally, here's a thing we never discussed. Flip the page to cosmetics. That's interesting, especially for you women. Now we have a cosmetic that contains vitamin C and ginseng. Do you use it?

The Chair: Yes.

Mr. André Gagnon: Is it a good product?

The Chair: I don't know. You be the judge.

Mr. André Gagnon: But the thing is that they say in the advertising that vitamin C is a powerful antioxidant that neutralizes free radicals, while ginseng helps to strengthen the resistance of the skin and whatever.

I'm just trying to translate right away, so it's not easy.

The point is, did you know that cosmetics are not subject to drug regulations? Maybe not, but that's a fact. Cosmetics have their own set of rules.

Ms. Elinor Caplan: There are no regulations?

Mr. André Gagnon: Cosmetics are part of food and drugs, but cosmetics have their own provisions, so they're not subject to the drugs definition. That's the point. So they can make claims, but they don't need a DIN number.

[Translation]

That being said, I would simply like to note that, if we try to deal with everything all at once, that is food and cosmetics, we will never get anywhere. We are especially concerned—and this is why the committee was struck—with the study of natural health products.

• 1640

Let us now move to the regulatory structure. We have come to the conclusion that an external advisory committee should be set up. We have no other choice. I think that has been made obvious. Now, if anyone thinks that we will agree to having an advisory committee under TPP, I would regretfully state that this would not be the case.

I'm not against the idea that an administrative body could be set up under TPP. I am not against this idea, because this whole area needs to be managed and documented. We therefore need some kind of bureaucracy. But when it comes to assessing claims and developing policies and regulations, this should be done in consultation with an outside advisory body. This has been mentioned, and we strongly recommend this option. It would be unthinkable today that TPP might develop policies and regulations without consulting stakeholders. We would no longer go along with that.

In any case, in our Canadian system of government, the ultimate decision-making power rests with the government or with appropriate officials. What we want is to have greater participation on the part of industry and stakeholders, so that we could have some input as well as some oversight.

I would now like to deal with an important point. You have heard about countless types of medicines, Chinese medicine, Ayurvedic medicine, and many others. In order to deal with that, we would need to establish task forces made up of experts in each of those medicines, if indeed we want to establish different categories.

I would like to give you an example: you might have a task force on Chinese medicine that would be tasked with collecting, assessing, justifying and recommending existing monographs to the advisory committee, which would then make its recommendations. That would be one way of going about it. I know this is getting a bit technical. With your permission, I could go into even greater detail in order to explain what we are suggesting; this is really the heart of the matter. Obviously, an appeal process would have to be put in place.

In the interim plan,

[English]

for me personally this is the most important thing. As I said, we cannot wait three, four, or five years for something to happen. I don't accept being illegal for many years still.

What has to be done fast is to form

[Translation]

an external advisory committee. It would have to be established as quickly as possible, and the task forces would also have to be established as quickly as possible. Even under the present legislation, we could begin to work on this.

The main obstacle is nevertheless Schedule A. As long as Schedule A is in place, we will always be coming back to square one. It will be like hitting our heads against a brick wall. Schedule A would prevent us from making any claim whatsoever even when the quality of the product has been demonstrated.

I hope that you have understood the importance of Schedule A. As long as that schedule is in place, we will be unable to make claims about 90% of the products that we want to sell. So, we must, as quickly as possible and by all means possible, try to do away with Schedule A, or at least try and ensure more flexibility in its enforcement. I think we have what it takes to achieve this objective.

Schedule A, which is attached to your material, states that we cannot make any claims in respect of certain diseases, such as prostate diseases. We can nevertheless be flexible in enforcing Schedule A, so as to allow claims with respect to structure or function. We have not as yet had any suggestions to that effect, but this would be reviewed by the experts' advisory committee.

It would then be possible to test a product for a year or two inasmuch as co-operation among those involved can be achieved. Obviously, in the meantime, we have to make a choice and decide to go on with TPP. We have no other choice for the time being. Something has to be done. So, if we establish advisory committees, and if TPP continues to refuse nine products out of ten, despite having task forces and an advisory committee, we will have to decide on a new strategy. We can meet again in two years' time and decide to set up a separate agency which would answer directly to the government, and not to the Health Minister. Hopefully, it won't come to that. I am convinced that there are other means to achieve this.

For the moment, it is imperative to go ahead with the consultation process in order to define and put in place the new regulatory framework.

[English]

I think the researchers will have to do a final report to give to Minister Rock. What we wish to have is a continuing process of consultation with the stakeholders. Having done all this work, we cannot at the end come back to the minister, go through the same bureaucrats we've been opposed to, and have them tell us “This is what you're going to do and this is how you will operate”. I'm just asking that we still be consulted right to the end.

• 1645

[Translation]

Thank you very much. We shall see you again on May 13, and I shall also be with the advisory committee. Thank you.

[English]

The Chair: Mr. Gagnon, there are just a couple of things in your booklet I would like clarified. Could you explain the use of the words “treatment” and “claim” in your risk assessment model? Maybe it's the same thing. I'm mixed up in that.

Mr. André Gagnon: All right. A type of claim is whatever claim it is. A structural function is a type of claim, a risk reduction is another type of claim, and a treatment is also another type of claim.

The Chair: So the word “claim” goes up there on each column. Okay, I think that makes that clearer.

On the next page, under marketing of NHP, could you just read the last line under 1? In English it says, “It's important to recognize the value of existing” something or other.

Mr. André Gagnon: It's “existing foreign documentary literature”. Excuse me, please. I just did that last night and this morning.

The Chair: I can tell by the bags under your eyes. Maybe you should use that product. Maybe that would work.

Mr. André Gagnon: The problem is the light. It comes directly in my face.

The Chair: I have no excuse for mine.

I just want to ask you a question about what you've been talking about, the advisory panel and committee. It's the advisory panel you're talking about, isn't it, and when you say committee you're talking about us?

Mr. André Gagnon: I'm talking about the Advisory Panel on Natural Health Products.

The Chair: That's the one you sit on?

Mr. André Gagnon: Yes, that's it.

Ms. Elinor Caplan: But you're talking about the establishment of a new external advisory committee.

Mr. André Gagnon: Yes. The thing is that the advisory panel is not permanent. The new committee that would be formed of course would have to be somewhat fun. I've been spending most of my time in the last year on this matter. If I'm part of an outside expert advisory committee, it has to be somewhat fun because this is a serious task.

Mind you, TPP will tell you they have in place right now an external advisory committee, which they call EAC. They must have talked to you about that. I know five of the people who are on that committee do not have time. One of them is a professor in Halifax. Those people have their day-to-day work. They don't have time to commit.

The Chair: He's also on your advisory panel.

Mr. André Gagnon: That's right. Three of them are. They simply don't have the time to commit. What's the use of having a committee if people cannot work and don't have the time and are not paid to do it? Let's be real; let's not do things that I won't accept as being intellectually honest. I'm ready to work, if we work in true and honest fashion.

Ms. Elinor Caplan: Let me leave André for a minute.

Mr. André Gagnon: I have to tone down a bit.

Ms. Elinor Caplan: Mr. Bohémier, do you belong to the same association as Nicole Renaud?

Mr. Guy Bohémier: What's her association?

Ms. Elinor Caplan: It's a naturopathic association. Are you a naturopath?

Mr. Guy Bohémier: Yes, I am. The name of our organization is Collège des naturopathes du Québec.

Ms. Elinor Caplan: Hers is the Association des diplomés en naturopathie.

Mr. Guy Bohémier: No, that's someone else. That's another association.

Ms. Elinor Caplan: What's the difference?

Mr. Guy Bohémier: A naturopath may have different training. They go to separate schools and they belong to whatever association they want.

Ms. Elinor Caplan: I see.

It's interesting that you use the word “efficacy”. The example of scurvy I thought was a very interesting example, the lime juice. It seems to me that part of the problem with your example is that while there was a theory, there was no proven efficacy through the normal research studies that lime juice prevented scurvy. Yet you've made the statement that products should have proven efficacy.

The concern that I have is that the mandate today for Health Canada food and drug, particularly on the drug secretariat, is to prove efficacy. The standards of research, clinical trials, double blind tests is enormously expensive. When you use the word “efficacy” in relation to natural therapeutic products, natural health products, herbs and so forth, are you saying that the existing monograph that Mr. Gagnon referred to is sufficient proof of efficacy?

[Translation]

Mr. Guy Bohémier: Yes.

[English]

Ms. Elinor Caplan: You're not suggesting that we need to have the kind of research we have for drug products?

[Translation]

Mr. Guy Bohémier: No. Although you may think that the pharmaceutical industry is very well equipped, in fact, the reality is quite different. The pharmaceutical industry, using all the means that we know they have, employ their own researchers who do research on their own products, and they then present the results to the government, which in turn will have a look at them and accept them as they are. The government does not have the means to check them or challenge them, because they have no researchers in their employ. So, since the research reports are well presented, they accept their results wholesale, thinking that the research is surely well done.

But in fact, the reality is totally different. It happens every so often that a product is marketed and then recalled three years later because it is causing problems. So the research that takes place in the pharmaceutical industry is not necessarily well done. We are talking here about biased research, whereas the research that we are referring to is carried out by independent people.

[English]

Ms. Elinor Caplan: I want to just clarify that, because there's some confusion when you use the term “proven efficacy”. Today, Health Canada says “proven efficacy” means use of the model of research that we use for drugs, and that's why I've been talking about an alternative method in the subject.

[Translation]

Mr. Guy Bohémier: There is a model imposed by the industry and that nobody within government counterchecks. However, in everyday life, within research in general, the research is less biased and you may end up with results that are more valid. When I talk about research, I am referring to the full scale of research that is talked about in scientific literature.

[English]

Ms. Elinor Caplan: Thank you very much, Mr. Bohémier.

Mr. André Gagnon: Ms. Caplan, the government does not only work with traditional scientific studies, because in the case of some policies on traditional herbal medicine, they did accept reference on traditional literature, so they had—

Ms. Elinor Caplan: Sometimes....

Mr. André Gagnon: They did, by principle, accept traditional literature.

Ms. Elinor Caplan: Isn't the problem that it's not consistent?

Mr. André Gagnon: The problem is that because of schedule A again, you may only have claims based on traditional literature, because schedule A limits the possibility of claims to be made. Secondly, of course, they limit the claims through the nine conditions, so this is another big hurdle.

Ms. Elinor Caplan: To further my questioning, Mr. Gagnon, first of all, I'd like to know if this is a preview of what we're going to hear from—

Mr. André Gagnon: Fairly much, yes.

Ms. Elinor Caplan: Fine. That's helpful. Thank you. You have started to think about it.

On abolishing schedule A, are you saying abolish schedule A or are you saying review schedule A in light of the new paradigm and determine those items that are on schedule A for which there are monographs and literature that would allow them to reclassify it?

Mr. André Gagnon: There was a very good document prepared by Andrew Adams, who is an employee of the government. I believe you have that document. You had it in the presentation of the ANPS in February. This document is about 30 pages thick. It gives a lot of parameters of how and why we should abolish schedule A.

Do you have the document? Good. It explains a lot.

To answer your question, if we start keeping some diseases in there—oh, heart disease is a serious condition, we cannot leave that open—that's not true, because you may make a claim for a reduction of the cholesterol level, which is helpful for the reduction of risk disease. It's not because the words seem strong that we should keep it in the schedule. It depends again on the claim you make. Do you see? So if it's proven, like fibre can help prevent cancer of the colon, why not?

We're talking about prevention. You're not talking about treatment, so it's based more on the claim than on the disease itself. So let's not be scared by the fact that the disease is big.

• 1655

Ms. Elinor Caplan: So what you are proposing is to take the items that are presently in schedule A and test them in the new risk or safety assessment paradigm.

Mr. André Gagnon: Yes.

Ms. Elinor Caplan: Instead of schedule A....

Mr. André Gagnon: Of course, there are some legal intricacies. I don't know them exactly, but that could be discussed.

Ms. Elinor Caplan: The next question I have is where you say to take into account costs associated with the proposed system. What does that mean? We can take it into account.

Mr. André Gagnon: Which one is it?

Ms. Elinor Caplan: Your recommendation that is second from the bottom.

Mr. André Gagnon: The point is that at the panel there was a great discussion about the preassessment of claims or not. We talked about whether or not we should assess all claims. As a mandate, should you take into account the cost of the system, or is cost no problem? I don't know.

If you say to me that the government and Minister Rock will say no problem, go sky high, fine. I don't think that will be the case. If cost is an important factor, I don't honestly believe we can put in place a system that would be less costly than right now, which right now is too costly anyway.

Ms. Elinor Caplan: So your recommendation would be...?

Mr. André Gagnon: My personal recommendation would be that his structure function claim doesn't need to be preassessed. That doesn't mean you don't carry any proof in your documentation. Of course you need back-up support in documentation. Of course you can still have it on file if the government comes to you and says please justify that claim to me; it looks weird; it looks too exaggerated.

I'm trying to make a balance between danger for health and risk for health. If the product is safe, I don't feel that a structure function claim is dangerous, even if it might not be completely efficacious. It sounds funny to say that. It sounds like that's not serious. It's all a balance; it's a political choice.

Ms. Elinor Caplan: Okay. I don't want to put you on the hook—

Mr. André Gagnon: It doesn't matter.

Ms. Elinor Caplan: We heard from Mr. Aubé that he has a product and he has some evidence that it's okay for cholesterol reduction and prevention and it's presently for sale for weight reduction. He says it's not.... How would that work in your system?

Mr. André Gagnon: No problem, because do you know what? Will you use a weight loss product if it's not efficacious?

Ms. Elinor Caplan: I'll answer your question after you finish.

Mr. André Gagnon: Okay, I should not answer by a question, right? It comes back to the danger for health. I personally feel that

[Translation]

if the product is not effective enough,

[English]

people will stop using it. I still feel we have to take that into account. If a product doesn't give results, why would a person continue to use that product?

Ms. Elinor Caplan: Continue to use...so that's my answer to you. If someone says this might help you with weight loss, I might want to try it to see if it works for me even if there's no proven efficacy. If it doesn't work for me, I'll stop taking it.

Mr. André Gagnon: I see what you're saying. It makes sense.

Ms. Elinor Caplan: Even if it does work for me, I may stop taking it.

Mr. André Gagnon: It makes sense. Instead of being absolute in your wording, if it has not been preassessed you might use some kind of wording that may leave it a bit more open.

Ms. Elinor Caplan: Many people are coming to us and saying they want the freedom to try it as long as it's not going to hurt them.

Mr. André Gagnon: That's it.

Ms. Elinor Caplan: Thank you.

The Chair: We'll go to Madame Picard, but I have a few short questions first.

[Translation]

Ms. Pauline Picard: I have no other questions. Thank you.

[English]

The Chair: She has no questions.

Back to your risk assessment model where you have the shaded-in part, the higher safety, are you saying that right across that whole thing you would require no preassessment?

Mr. André Gagnon: No.

The Chair: Not even under treatment?

Mr. André Gagnon: Excuse me again, but this was finalized this morning because of all the work we did on Tuesday, Thursday and Friday; it might need a bit of refinement.

If you look at it right now, there would be no preassessment for the structure function claim. Risk reduction we're still debating about. I have to be honest with you, in fact; I'm still debating with Guy here, who also acts as a consultant for a company, by the way. For treatment that's definitive, if there's no monograph for labelling standards for treatment, you could not go on notification. You would have to preassess if your claim is based on other kinds of evidence.

• 1700

The Chair: Just so when you're talking to people like yourself who have no medical training or scientific training, I think that word “claim” should go in there on each place. If that's what they mean, just put structure function claim—

Mr. André Gagnon: I could submit a more defined graph to you.

The Chair: I guess we're going to get them—

Mr. André Gagnon: You're going to get them anyway next week, yes, on the 13th.

The Chair: —officially in a couple of weeks, and maybe we should wait a week until we get them officially, if that's where it's all coming from.

I think that's all, if there are no more questions. Thank you very much.

[Translation]

Mr. André Gagnon: Thank you very much.

[English]

The Chair: If you have anything more for us...if you can do this all in one night you might have more for us in the next couple of weeks.

Thank you very much.

We have two people left who we'd like to hear from: Dr. Yves Roy, and I think it's Mark Perlstein. I don't have the official paper here, but that's who I think it is.

• 1705

Would you like to go ahead and explain...? I should say you're a medical doctor.

Dr. Yves Roy (Individual Presentation): Yes, indeed.

The Chair: In nutrition, anthropology and...it's energetic health?

Dr. Yves Roy: That's right.

The Chair: I don't know what that is. Are you going to explain that?

Dr. Yves Roy: Sure. Acupuncture and homeopathy are all about energy, because you don't have any molecules left—

The Chair: Sorry, I've never heard it called that before.

Dr. Yves Roy: This energy is electromagnetic in nature. We are starting to see it now in nuclear magnetic resonance, and it's at the forefront of medicine, the cutting edge of medicine. A lot of the natural or so-called natural treatments or therapies do call into play the energies of the human being, and we're starting to see them now on monitors. And that's the future medicine. A lot of the so-called natural products or natural therapies will tie in with high-tech medicine in the near future, and we're already at that stage.

The comments that I have today—

The Chair: I won't count that in your time, so you now have ten minutes.

Dr. Yves Roy: I have prepared in French. Is that okay? There's no problem?

The Chair: That's fine.

[Translation]

Dr. Yves Roy: I am sorry I could not submit a brief, due to a lack of time. I am addressing your committee, not to put forward any specific recommendations of a technical nature, but rather recommendations of a moral nature. I will talk very briefly about my background and convey to you my thoughts regarding health and therapies.

I am a doctor and I graduated from McGill University, here in Montreal. Previously I was a researcher at the Université du Québec, Institut Armand-Frappier. Following that I studied a number of different medicines and practised as a general medical practitioner. I devoted a large part of my time to alternative medicine, homeopathic medicine, and especially energy field therapies. I devoted a lot of attention to energy, to what may also be called magnetism. I practised medicine for about ten years.

In light of my personal experience, I must say that I am for freedom of choice in health and that, for me, a harmonious relationship between the therapist and the patient is of the utmost importance. The therapeutic relationship is the most sacred thing there is, so it is the most important thing.

Just as the patient has the right to choose his psychologist, he also has the inalienable right to choose the therapy that he thinks is most appropriate. If a person thinks that some methods or natural products, among them magnetism, homeopathic medicine or nutraceuticals, suit him or give him a feeling of well being, the patient is the only judge. Any therapy, any product or approach that the patient feels does him good must be respected, without any external intervention from any authority, especially if the patient is not happy with conventional medicine.

I believe—and that belief is more and more widespread within the Canadian population, which is increasingly well educated—that there is an absolute right to complement the long established treatments. There is also an absolute right to refuse any established treatment, those that are effective only for a given period; in effect, a treatment could be the preferred treatment for a relatively short period, after which science or medical philosophy would discover a new approach. The patient has the right to refuse an established treatment that might be taken off the market in two years, for instance.

And also, because of the psychology of biology, people have an absolute right to alternative medicine with no outside intervention. Each human being has a unique biology and for that reason it is very difficult to standardize treatments.

A so-called scientific remedy could have positive effects for 70% of people, no effect whatsoever for 20% and be dangerous for the other 10%.

• 1710

The psychology of biology, which is the way biology reacts, is unique to each individual. The difference is more obvious between races but it can also be seen between individuals. That's why it's so difficult to have studies as strict and as controlled as scientists now claim to make. Each human body is unique and we have to recognize it.

The individual and his or her body is the only one who can judge such and such a therapy from its effects. Outside entities, such as professional corporations, cannot make that decision for individuals. People must make up their own minds and benefit from all the technical support they can get from medical high technology and from science. More importantly, they must rely on all the perceptions of their biology's psychology, perceptions coming from their bodies. We have to respect people's choices, whether it's their psychologist, their family doctor, their natural products, their pharmacist or their yoga teacher.

Consumers have an absolute right to refuse traditional therapies that they deem inappropriate or that they do not trust. Conversely, people have an absolute right to choose any non- traditional therapy which they trust and which improves, measurably or not, their health or their physical and psychological well- being. No one has the right to decide for consumers if certain innovative, non-traditional or obscure therapies are appropriate or not. If you wait for everything to be proven before you move forward, there will never be anything new. To evolve and innovate, you have to use all of the information available and build on it. Instead of closing the door, we should accumulate new knowledge.

I have some comments I'd like to make. What right have professional corporations to invoke public safety as a pretext to judge alternative therapies while they only have a superficial knowledge of some of those therapies, the number of which is constantly increasing in any case? They have no authority to judge those therapies and moreover by passing judgment on them they put themselves in a situation of conflict of interest.

With the 21st century at our doorstep, our first priority should be education. We should educate people and make them aware of all that is available. People must have choices if there is to be freedom of choice and if Canada is to be a free country. If there are no choices, there is only one path we can walk. Education is very important.

Prevention, which is the best of cures, has to apply. Human beings must be respected in their dignity, in their individuality and in their freedom of choice. Natural and energy-based therapies that are not recognized as scientific therapies are so, even if most of them are brushed off. While current scientific approaches are based on observation, hypotheses and experimentation, any phenomenon that is a source of well-being for humans has to be explained with a superior approach, that of pure science. I could explain it through the physics of mathematics, geometry or energy, but I'm afraid I might loose you.

I will now conclude my presentation and on behalf of my fellow citizens, I'd like to thank the committee for hearing me. Thank you very much.

[English]

The Chair: You got me curious, anyway. I have to read about all those things you think we wouldn't be able to understand.

Do you have any questions, Madam Caplan?

Ms. Elinor Caplan: I want to hear from the other witness first.

The Chair: If you want to do it that way, it's totally up to you. It wasn't meant to be that way—he gets his time and he gets his time.

Ms. Elinor Caplan: This has to do with your hypothesis on whatever works for you, and I would just share with you a story that maybe tells you a little bit about my understanding of what's efficacious and what works.

The husband of a friend of mine is very afraid of flying, and in his business he was required to fly. So they had a choice: he could undergo extensive counselling and therapy to try to deal with this fear; but a friend had said that there was a certain bracelet, and if she wore the bracelet and she put it on when the plane took off and she took it off when the plane landed, he would be able to fly safely.

• 1715

When she told me about this, I said, “This is ridiculous. You're wearing a bracelet and he flies safely. I don't see any correlation.” She said “It works. He's never had a plane crash. I put the bracelet on when he leaves and take it off when he returns. He feels safe to fly. Why are you questioning the effectiveness of this product?”

Dr. Yves Roy: Right. Well, there's a lot of belief. That's why belief, or the therapeutic relationship, is extremely important. If you do things you don't believe in, you will not get results, and that's the power of the human mind. But it's also the power of whatever the therapist or physician emits in terms of personal energy. Sigmund Freud said first there is a phenomenon that has a para-scientific basis, but once the phenomenon has been explained it passes into science.

Let's not sift out the phenomenon of natural medicine, which is a growing phenomenon that will be explained in stringent, very hard scientific terms in the years to come, or maybe in the century to come. First, let's use it because it does provide a lot of good to a lot of people.

Recent articles in Scientific American prove the existence of magnetic energy. Chromosomes come up only in certain cells when they're magnetized by different lights. The intention of the researcher is extremely important. If he believes in what he's researching, he will find an answer and chromosomes will pop up. If he doesn't believe in what he's doing, they won't pop up. There are many things that are coming out. The human being is on the border between matter and energy, so we're energy beings. We have to recognize that.

The Chinese people have known that for 2,000 years and we're recognizing that now. We're trying to see it on magnetic nuclear resonance and other techniques, which offer us a peek into the human energies. They're really the door to 21st century medicine. A lot of this natural medicine or folk medicine we're using is based on energies. This is arcane for a lot of people, and to explain it in scientific terms demands a lot of studies, but we're getting there.

I think with the increment in the level of education of the population, people are now able to judge for themselves what works for them. They're able to question their physicians and their naturopaths and question whatever is out there. I think that's part of the raising of the consciousness of the population. Education remains the key to that.

The Chair: Thank you.

Dr. Yves Roy: Thank you very much.

The Chair: Mark, would you like to go ahead? Mark is from Mannatech Incorporated.

Mr. Mark Perlstein (Individual Presentation): Mannatech is a company from the United States that is working very closely with the FDA in implementing some of the new regulations that will be coming into effect to work with label claims and different types of claims, which I thought were discussed very well here today.

The Chair: Are changes being made to DSHEA?

Mr. Mark Perlstein: No, it's just the implementation. In other words, when the law was signed into effect in October 1994, it was supposed to be implemented in October 1996. They did a little foot-dragging on it, and finally, as of last year, they are now implementing this new law. It used to be called the Hatch-Harkin; now it's called the Dietary Supplement Health and Education Act.

The Chair: Are you from a consulting firm, or do you make chemical products?

Mr. Mark Perlstein: It's a research and development firm that also has a line of products.

Since I am the last speaker, I would like to compliment all of the previous speakers. I thought they did a wonderful job, and the committee had some excellent questions. It's really good to see we're have an open discussion like this, because these are very important matters.

I'm going to bring a layman's point of view here; it's something very simple. There were a lot of very good professionals here, such as Dr. Roy—I know him and he has a lot of credibility here in the Montreal area—and some of the other people who spoke before him. I only have a few minutes, so I want to keep it brief and just kind of summarize.

• 1720

The Chair: Are you speaking for yourself or for the company?

Mr. Mark Perlstein: For myself. This is definitely for myself.

We really have to be very careful, when we classify natural products, to be sure we don't put them in the same classifications as drugs. They are different from drugs. Drugs in most cases are very specific in their actions and have side effects that could be very dangerous. Natural products fortify the body and in many cases have multiple effects because they give the body the ability to heal itself.

Earlier, I heard a little bit of a back and forth with the cholesterol and weight loss issue. I have seen it many times, where one particular natural product could have an effect on four or five different conditions. It is very possible that it could help you to lose weight and also help your cholesterol problem. This I see all the time. We see this many times with endocrine support or hormone support. When you support your hormone system you can lose weight, because the metabolism helps you to lose weight.

We could see hormone problems coming under control, like PMS, and all kinds of different problems like this. Energy levels, concentration levels—sometimes it's just endless what natural products can do. We have to realize that. It's not always the one-for-one approach of a pharmaceutical drug, where they're just treating a symptom with a drug.

We have to also realize—and I think Dr. Roy touched on this—that everybody will respond differently to different types of products. Some people will get excellent results, some will get mediocre results, some might not get any results.

I believe a new category—and that was covered very well before—should be created and either called functional foods or nutraceuticals. The key here, I believe, is scientific validation. If you educate the consumers with scientific studies and they can see what these products do in different disease stages or just prevention of whatever the case may be, then as long as they're natural and non-toxic they should be able to be given out to the public. The consumer should be allowed ultimately to decide what he or she wants to put into his or her body.

The DSHEA law—and I think this is so important and it's really being overlooked—if you read the beginning of it closely, was created to ultimately lower health care costs. In the United States 17¢ out of every $1 the government spends is spent on health care. This is a huge cost. By making people more healthy, we can probably lower those costs. So it's a very common-sense approach to a growing problem, because right now the allopathic community at large, which is basically the pharmaceutical companies behind it, has created a situation where it's just totally out of control.

I know someone with fibromyalgia who is being given anti-depression drugs, because they feel so bad that they're depressed. Of course they're depressed; they're sick. The anti-depressive drugs do nothing to help the problem and they're just getting all the negative effects of a drug like Prozac or something like this, which obviously is very negative to the body.

The approach should be to try to fortify the body, and give the body what it needs to fortify itself. It's like eating a carrot. When you eat a carrot, you don't do that because you have specific problem and say, “I'm going to eat a carrot to take care of that problem”. The carrot has all kinds of different vitamins and minerals, phytochemicals—all kinds of different things that will work on many different things—so the body will function better. And when the body functions better, it can take care of itself.

Our bodies are the miracle. There's no drug and no natural product out there that is the miracle. The miracle is right here. We're all walking around in our own miracle. If we take care of our bodies and put these functional components or functional nutrients into the body, which the body needs to take care of itself, we really, truly will be in better shape and probably be starting to spend less money on health care.

One last thing. I've seen many people in the course of my life who don't have a lot of money and who are taking pharmaceutical products knowing that natural products would be better for them. They don't have a choice, because the pharmaceutical products are covered by insurance policies and the natural products are not. So they have to take the pharmaceutical products, and they are getting the side effects and the negative effects of the pharmaceutical products in a lot of cases, and not having a choice.

• 1725

If we can get a progressive law in effect that is fair, that is safe, and that I think can very easily be done.... I heard of many different ways of doing it today. If we can just be open and not put under the pressure of the pharmaceutical industry.... It is a huge industry. They have a lot of money. They have a lot of lobbying power. In Europe they're big. They have Codex in Europe, which is trying to take over the whole world. This Codex plan wants to take the whole world. I think Canada has already pretty much signed on to it.

We have to look at this. We don't want the same people who put us in the situation we're in now to regulate a new group of products coming in that could possibly take us out of the situation we are in now. We should really try to get a fresh approach with some fresh people, and not go back to the same people who really put us in....

Our diseases right now—we have things we never heard of. Twenty years ago we'd never heard of chronic fatigue and fibromyalgia and all these different things. Now it's common—arthritis, diabetes—it's totally out of control. That's because we totally overlooked prevention and taking care of the body, which ultimately can take care of us.

Thank you very much.

The Chair: Thank you very much. Any questions? Did you have any questions for each other? No? Okay.

Thank you very much, and thank you to everybody else—the committee, the clerks and the researchers and the interpreters and the console operators.

The meeting is adjourned.