STANDING COMMITTEE ON HEALTH

COMITÉ PERMANENT DE LA SANTÉ

EVIDENCE

[Recorded by Electronic Apparatus]

Thursday, March 19, 1998

• 0915

[English]

The Chair (Ms. Beth Phinney (Hamilton Mountain, Lib.): Ladies and gentlemen, I call the meeting to order.

This is meeting 29 of the Standing Committee on Health and we're doing a study of natural health products.

Today we have two groups represented. From the National Association of Pharmacy Regulatory Authorities we have Barbara Wells, the executive director; Jim Dunsdon, the chairman of the Inter-Provincial Regulatory Committee and the Registrar of the Ontario College of Pharmacists; and Dr. Linda Suveges, who is chairman of the National Drug Scheduling Advisory Committee. Then from USANA Canada—maybe you could explain what that is afterwards—we have Warren Te Brugge, who is the managing director.

We'll go in that order, and I hope each group can keep its comments to around five minutes. I don't know if you were planning on five minutes each, but if that's what you've planned it's okay. The longer you take, the fewer questions we can have, and the members really want to ask their questions. When they do their questioning they get five minutes, and that includes their questions and your answers, so please keep your answers relatively short. Again, if it goes over a little, we'll be lenient, unless somebody complains among the members that somebody is going on too long. I'll put it on their shoulders.

Barbara, do you want to start first?

Ms. Barbara Wells (Executive Director, National Association of Pharmacy Regulatory Authorities): Sure.

Madam Chair and committee members, I'd first of all like to thank you for this opportunity to address the committee this morning. I'm Barbara Wells and I'm the executive director of the National Association of Pharmacy Regulatory Authorities, or NAPRA.

My colleagues with me this morning are Jim Dunsdon, the registrar of the Ontario College of Pharmacists, one of our members, and Dr. Linda Suveges, who is chairman of our National Drug Scheduling Advisory Committee, or NDSAC.

NAPRA is an association of provincial pharmacy regulatory authorities and we were founded to facilitate the activities of provincial pharmacy regulatory authorities in their service of public interest. You should have this morning a pamphlet about NAPRA.

NDSAC, our drug scheduling committee, was formed by NAPRA to advise the provincial pharmacy regulatory authorities on the conditions of sale for drugs, that is, what restrictions should be placed on public access to a product and what level of involvement is required of physicians and pharmacists to ensure safe and appropriate use of the products.

We're here today to offer you a plan for the regulation of natural health products. This plan builds on a credible and proven system that already exists for the regulation of drugs. It focuses on consumer safety. We believe it will prove to be acceptable to the key groups from whom you have already heard—consumers, manufacturers, retailers, health professionals, and regulators. We have this confidence because of the track record of NDSAC, which has moved Canada from a very confusing patchwork of drug schedules to a smoothly operating cost-effective system that has the support of stakeholders. The last appendix in our submission has a list of our key stakeholders.

Madam Chair, we know you have heard many briefs now giving you a range of views and much information about natural health products. We would like to use our time to discuss our plan.

First, I would like to summarize our position on natural health products. Consumer safety must be the primary guiding principle in making decisions on the availability of any health products to the public.

Second, members of the public should have optimal access to the natural health products of their choice, but balanced with their right to be protected from undue risk and to receive the information they need to use each product safely.

Third, there is a need for a regulatory framework for natural health products.

Fourth, the framework should not place unnecessary constraints on natural health products manufacturers and retailers.

Fifth, the framework should be complementary to the system regulating drugs, foods, and nutritional supplements.

Sixth, we support the advisory panel on natural health products' recommendation for a third class of product—a position between drugs and food—as an efficient way to ensure consumer safety.

Seventh, there is a need for a new organization within Health Canada with staff that have natural health product expertise.

Eighth, there is a need for unbiased and understandable information on individual products for the consumer and for better information for health care practitioners.

• 0920

Lastly, we support the application of good manufacturing practice guidelines for natural health products.

A little bit about NDSAC. In Canada, as you well know, all therapeutic drugs are reviewed by Health Canada for marketing approval. Health Canada determines whether a drug should be placed on the market and whether a prescription is required to obtain it. Health Canada does not, however, decide on the conditions of sale of non-prescription drugs, because this falls within provincial jurisdiction.

Over the years, discrepancies appeared among provinces with respect to the conditions of sale for the same drug product. This happened because conditions were established on a province-by-province basis. As a result, a consumer travelling from one province to another found different conditions attached to the sale of the same product. These differences were unjustifiable, were very expensive for manufacturers, and made no sense to the public.

Canada now has a harmonized national model with four categories of conditions of sale for drugs. The most restrictive is schedule I, for drugs requiring prescriptions for sale. Schedules II and III are for non-prescription drugs requiring different levels of involvement by a pharmacist. Unscheduled drugs can be sold in any retail outlet because of their low risk.

The model for making drug scheduling recommendations embodies what we call a cascading principle, in which a drug is first assessed by NDSAC using the factors for schedule I. We have a schematic of the cascading principle in the appendices.

Should sufficient factors pertain, the drug remains in the schedule. If not, the drug is then compared to the factors for schedule II and, if appropriate, then assessed against the factors for schedule III. Should the drug not meet the factors for any schedule, it becomes then unscheduled and is considered safe enough to be sold in any retail outlet.

NDSAC's seven expert members were chosen from across the country for their knowledge and experience in appropriate disciplines relevant to the Canadian public and to the health care system. They were appointed in consultation with our stakeholders. Again, we do have a list of our current NDSAC members in the appendices.

Each NDSAC member is mandated to serve in the public interest, aiming to promote optimal drug use while recognizing the role and responsibility of the patient in their health care.

In addition to these expert members, a representative of the Consumers' Association of Canada also serves on the committee to ensure that the views of the Canadian public are directly represented in committee decisions. NDSAC reviews original submissions from the manufacturer, along with Health Canada documentation and individual member research, to develop its recommendations. An appeal mechanism for these recommendations is now in place.

The creation and operation of NDSAC was grounded in the following four rationales: consumer safety is paramount; national harmonization of conditions of sale is logical, cost-effective, and beneficial to all stakeholders and facilitates international harmonization; the system deals with relative risk to human health; recommendations are based on objective factors.

It is important to note that while NDSAC is not a stakeholders' committee per se, it has earned their confidence. We have included a letter from one of our major stakeholders as well, expressing their support for our scheduling structure.

To date, NDSAC has made recommendations on 67 drug schedule placements—and I should note that is since 1995—eight of which concerned a switch from prescription to non-prescription drugs. Of the remainder, 35 were acknowledged to be of sufficiently low risk that the committee recommended they be available for sale without prescription and without restrictions—that is, that they be unscheduled.

Madam Chair, a credible, objective system for regulating drugs already exists. We are proposing a plan for natural health products modelled on this proven system for drugs and using some of its components.

We are proposing a system in which all natural health products will be regulated according to risk to human health. We support the advisory panel's guiding principles and note that their framework is based on consumer safety, as is NDSAC's. The risk factors presented in the advisory panel report are also based on a cascading principle of risk, from high, which would probably be prescription status, to medium to low, which would probably compare with schedules II, III and unscheduled.

Our plan complements the existing system for the regulation of drugs. We recommend that for this plan to be effective, it must be considered as a whole, because the components are linked and interdependent.

Madam Chair, I won't go through the steps for review of the application for market approval, because I know that this committee has received information from Health Canada on these steps. Instead, I would like to focus on the conditions of sale.

• 0925

We are recommending that a national approach be taken using NDSAC and the national drug scheduling system as a model that has already proven to be cost-effective and acceptable to stakeholders. With the addition of a complement of experts on natural health products, NDSAC could make recommendations on conditions of sale and labelling for natural health products. Thus, with the creation of a new unit in Health Canada and the addition of specific expertise to NDSAC, Canada would have an effective way to bring order to the natural health products market.

We should also note that NAPRA and NDSAC have been instrumental in improving pharmacy practice by setting standards and advising on product labelling. Pharmacists in particular need unbiased information because, for example, according to a recent survey, 56.9% of herbal remedy users shop for their alternative medications in drugstores. Pharmacists want to be able to speak to consumers with confidence on the safety and benefits of natural health products.

I won't go over the collection of post-marketing information either, because I know you're also aware of that.

We agree that Canada needs to deal with the question of the regulation of natural health products in a timely and effective manner. Our plan offers a way to do this. Many health care professionals, and indeed members of the lay public, do not appreciate the value of natural health products. Consumers are well aware of this and so may not disclose that they are taking them, thus omitting important information the health professional needs to treat the patient. Our plan would help alleviate this important drawback by giving natural health products their own unique status through a logical, objective system.

Madam Chair, I would like to thank you and the committee for listening to our presentation this morning. We would be pleased to answer any questions.

The Chair: Thank you very much.

Mr. Te Brugge.

Mr. Warren T. Te Brugge (Managing Director, USANA Canada Inc.): Madam Chair and members of the committee, thank you for giving us this opportunity to appear before you.

I represent a company named USANA. We're a public company based out of Salt Lake City, Utah. Our founder is Dr. Myron Wense. His vision is to create what he calls the “healthiest family on earth”, that being every individual on earth. Where we come from is we set extremely high standards for the products we manufacture and we believe the public has a right to receive the best products and products manufactured to the highest standards.

USANA comes out of a company called Gull Laboratories, which Dr. Myron Wense founded also. From there he realized his ability to feed and nourish cells at an individual level. He was forgetting that he was not nourishing his own body and his own family's bodies as a whole, and therefore he developed the concept of USANA. That was five years ago.

I believe there is a consensus among all parties that the current regulation needs to be reformed. However, the nature of the reform is what is difficult to determine. I'm sure you've heard from a number of different parties and a number of different points of view. We believe we need a system that is responsive and fluid and one that ensures the general well-being of the Canadian public is protected as well as promoted.

Our current system classifies products into two basic categories, foods and drugs, with some minor exceptions for some cosmetics and things such as sunscreens. Natural health products fall into an area in which they can be construed as both therapeutics and food supplements. Therefore these need to be categorized in a manner that does not confuse or mislead the public in any way.

The levels at which nutrients are included in natural health products need to be revisited at the same time, to reflect the correct levels of nutrients we require to remain healthy. There are bodies that can be used as a reference, such as the Council for Responsible Nutrition in the United States, and which have already invested significant resources in determining safe levels of individual components. These are generally known as the no observable adverse effects levels, or NOAELs.

• 0930

It is imperative that we do not make significant changes to good manufacturing practices for natural health products. Rather, make changes that allow our industry to participate at a more global level, aligning our regulations with those of international business partners.

Nonetheless, while we are proposing allowing Canadians a wider and more extensive choice in the products that they can use, we need to ensure that these products are manufactured to higher standards to ensure the safety of the public. However, in addressing this area of the regulations, we need to ensure that we do not shut out the small manufacturer by imposing requirements that limit competition.

Currently, compliance, enforcement, and monitoring are really left to Health Canada to handle, and it has limited resources. Although the government is certainly working to ensure that there is compliance, I believe a system involving both government and the private sector can be more effective and efficient. The government should determine what the regulations are and, in conjunction with industry, how they should be applied, while ensuring product safety and truth in labelling. At the association level, industry can monitor and enforce compliance to regulations through a member reporting process. The associations can then take action against the offender either directly or in conjunction with other associations where applicable.

Moving the compliance process to an industry level will create a fairer environment and participation between industry sectors. Where infractions are not able to be resolved at an industry level, these can then be escalated to government compliance divisions to finalize. Most of the groundwork will already have been completed and events will already be documented, thus allowing the government to act swiftly and decisively once it has evaluated the facts and evidence as presented. This cooperation will improve relationships between the private and public sectors and will create an environment in which all participants can coexist under the same set of rules.

Although there has been significant discussion in the area of establishment licensing and product licensing, in our opinion there needs to be a greater coordination of activities in this area. Product and establishment licensing are an important part in ensuring compliance and monitoring on an ongoing basis. However, the overall impact of government-levied fees and cost-recovery programs needs to be considered as well. This is particularly important when we are working in an environment that encourages small and medium-sized businesses.

There are fees that are levied at the federal, provincial, and municipal levels, and the extent and impact of these fees should not create a barrier to competition. These should be managed and coordinated to encourage an environment that provides the public with a wide range of choice, as well as one that ensures that products are safe and of high quality.

In the area of education, the private sector and government can work together. If the public had access to education about natural health products, and if it was presented at a component level instead of at a marketing or brand level, they would be better informed and better equipped to make intelligent choices based on what components to use. The choice at a brand level would then become secondary and would lead to less confusion in the marketplace.

We believe reform is also required in terms of the current methodology and ideology of what constitutes a well-balanced diet and an effective health system. It is widely believed that a person can obtain all the nutrients needed to remain healthy from their diet. However, with the proliferation of processed and convenience foods, fewer and fewer North Americans are achieving even the RNI levels of nutrients from their diets. It is becoming more and more evident that we need to supplement our diets with other sources of vital nutrients in order to live healthier for longer, not just live longer while coping with disease.

We rely on chemical and other invasive forms of treatments and cures almost exclusively, spending in excess of 95% of our current national health care budget on programs to treat disease and prolong death, rather than focusing more resources on preventing or reducing the occurrence of degenerative diseases. By focusing more resources on prevention and educating the public, we will reduce the overall tax burden on the public over the medium to long term.

There always needs to be more investment in the areas of clinical trials. Although there have been a number of trials performed worldwide, there is still generally a lack of focus on spending in the areas of nutrition and disease prevention. The problem is somewhat complex, but really comes down to involving copyrighting, economics, and profit. After all, how do you patent or copyright a naturally occurring vitamin or mineral? However, we believe that with the encouragement and participation of government, joint studies can be initiated now. Again, the focus should be at a component level rather than at a brand level, to ensure that studies are conducted in the best interests of the public at large.

Thank you, Madam Chair.

• 0935

The Chair: Thank you very much.

We'll proceed now to the questioning. Mr. Elley.

Mr. Reed Elley (Nanaimo—Cowichan, Ref.): Thank you very much, Madam Chair.

I want to thank all of you for coming and participating in the study we're doing on natural health products.

If I understand correctly, what those of you from the National Association of Pharmacy Regulatory Authorities are suggesting—and correct me if I'm wrong—is that we should utilize your offices and your facilities, along with Health Canada, to set up the plan you've suggested to us.

On the one hand, I must say it's refreshing to have a group come and present us with a plan. That, I think, is very commendable, and it's something we're looking for as a committee, to get input in terms of solutions to this. I think we've basically identified the problem over the last month or so. We know what the problem is, but we are looking for solutions to it.

However, having heard from many people, one of the concerns I would have with this would be the public perception—and I'm not saying whether it's true or not; I'm not commenting on its truth, just its perception—that already the large pharmaceuticals have their hands in this thing far too much, and that pharmacists, just because of the name perhaps, are somehow tied to the fortunes of the large pharmaceuticals, and that if we went with your plan, it would be another nail in the coffin to that. I'd like you to answer what I think would be a legitimate concern on the part of the public. Perhaps you could start with that.

The Chair: Mr. Dunsdon.

Mr. Jim Dunsdon (Chairman, Inter-Provincial Regulatory Committee, NAPRA; and Registrar, Ontario College of Pharmacists): Thank you. I'll make these comments as a regulator.

I take your point. I think there would be a perception, perhaps. However, I would point out that the NDSAC model is, first of all, an objective model and is not tied to pharmaceuticals per se, as you're sort of suggesting. While it has the support of stakeholders, including the pharmaceutical industry and other groups, such as the regulators themselves, the grocery industry, the non-prescription drug people, it is not a stakeholder-driven process. It's an objective process driven by factors that have been developed in as objective a manner as one can determine.

I'm sure Dr. Suveges, who has been here since the genesis of the process, will want to comment about that.

I think we are saying it has worked well for drug products. Obviously there would need to be some modification to add to the expertise, if you will, of the process, in order to deal with this third class of products that are not quite drugs and not quite foods. However, we feel it's a good model to work on and a good model to develop. Linda, I don't know whether you can add in terms of the credibility of the process.

Dr. Linda Suveges (Chairman, National Drug Scheduling Advisory Committee, National Association of Pharmacy Regulatory Authorities): Thank you for asking. We're only two and a half years old, but I think we've done a credible job of making recommendations that have been helpful both to the stakeholders and to the Canadian public.

One of the most valuable members of our committee is a member of the Consumers' Association of Canada, and I think we find it very valuable to have that input.

The people who are on the committee are basically scientists or practitioners. So there are several physicians, several pharmacists, people who have expertise in the area of drug information, of course, and we don't represent any one particular group of stakeholders.

• 0940

I do take your point, though, on the appearance. It doesn't matter that we say this; it's the perception people have.

Mr. Reed Elley: I will ask a question then that might lead this further. In your own discussions with people about this concern, have you made any attempts to talk with people in the natural health food industry to get their reaction to this suggestion? Have you done some market testing, so to speak, about this with them? They're the big stakeholders in this on the other side of the question.

Dr. Linda Suveges: I personally haven't. My job as chair of the committee is to sift through information, but maybe Barbara has had an opportunity to.

Ms. Barbara Wells: I have—not about this particular matter this morning, but we have had a very good relationship with the Canadian Health Food Association. When the drug scheduling committee was starting, they were included in one of the stakeholder groups. I don't want to put words in their mouths, but they were very supportive of a four-category national model because they felt it would bring some kind of order even to their world. That was before these hearings started. It was in the genesis of NDSAC. So I would say there has been a good liaison with that group anyway.

Mr. Reed Elley: I would suggest that it might be good to have tested this on somebody beforehand.

The Chair: Thank you very much.

Before I go on to Madame Picard, I'm going to ask a question that came from our researchers here. Can you tell me whether the experts at NDSAC have experience with the natural health products? Of the 67 products that were reviewed by NDSAC, were there natural health products? If so, which ones?

Ms. Barbara Wells: No, this committee has dealt only with drugs to date, and the folks we have on the committee were chosen for that. However, again we're promoting the model and the process rather than the actual issues being dealt with, and the committee does have expertise in weighing factors and gaining stakeholders' support and so on. I think we've acknowledged that we would have to get a complement of expertise on natural health products.

Dr. Linda Suveges: I would just add that although several of the products we looked at weren't billed as natural health products— We did look at the category of laxatives most recently with the group of 37 products we looked at. Things like senna and aloin were in there. Those are natural kinds of products that have been classified as drugs for many years, but I know they also exist in some of the natural health products that are available in other outlets.

The Chair: Madame Picard.

[Translation]

Ms. Pauline Picard (Drummond, BQ): Madam Chair, you have asked a question I myself meant to ask. That is not a problem, however, since I would like to have more details anyway.

I bid you welcome. I would imagine that if you are proposing solutions, it is because the members of your association have problems with the sale of natural products. I, too, like the Chair, would like to know if your members have any expertise for giving advice to consumers. If Health Canada were to adopt your plan as presented, what would your members need to do to comply with this plan? Would your members accept to undergo studies, or would they be able to develop an expertise to provide the clients of your drugstores with judicious advice?

[English]

Ms. Barbara Wells: I'll let one of our members speak to that.

Mr. Jim Dunsdon: Thank you. I again speak as a regulator here. As you're aware, like the order in Quebec we are charged with protecting the public interest in terms of regulating our members. We have expressed some positions to our members with respect to the question of knowledge and expertise. However, we have been relying, and would like to rely, on processes such as this to deal with some of those fundamental issues. In Ontario we have had a rather extensive study on naturopathy, and we are awaiting with some interest the results of that study. I believe other provinces have similar endeavours under way.

• 0945

I can speak for the Ontario college here for a moment. We expect pharmacists, first of all, to critically evaluate products and have knowledge about the ingredients of the products. Our focus is on safety because efficacy is unproven in this area. We want to make sure our members are satisfied that the public who are consulting them are doing so and it's a safe process. The pharmacist is expected to be satisfied that while the consumer has the right to seek alternatives, the consumer should be doing so within a safe environment.

Also, we would expect the pharmacist to recognize the need for medical intervention where necessary. The pharmacist is well-positioned for that. The pharmacist may have profile records on the individual consumer who might be seeking advice, and might be able to provide useful information, for example, in terms of side reactions that might occur vis-à-vis prescription medication and alternative medication that may be taken. The brief alluded to that problem in which individuals may hesitate to take advice along those lines. As a college, we have taken no position on the issue of therapeutic merit, and again, this is a controversial area, as you know.

To sum up, we do expect that pharmacists, when they provide advice—and we do expect them as a standard of practice to be available and accessible to give advice—to give advice that is focused on consumer safety and knowing when to advise the consumer to seek medical consultation where appropriate.

Ms. Barbara Wells: I would like to add to that. NAPRA has developed standards of practice for non-prescription drugs, and you have a copy of that before you. We're also ready to launch standards of practice for prescription drugs, and they will be finished next month. I know that Jim and his colleagues, other registrars across Canada, are planning to do standards of practice and include natural health products as well in that.

Pharmacists are expected and will be given tools to make sure they are very knowledgeable about all the health products sold within a pharmacy, and there are some standards of practice for health products being developed now.

[Translation]

Ms. Pauline Picard: Does your university training as pharmacists provide you with the required basic knowledge on existing natural products?

[English]

Dr. Linda Suveges: Maybe I'll answer that. I am a faculty member at the university in Saskatoon. I think it varies across various programs, but I think as educational institutions we've identified that we need to add or expand in this area.

Of course, 20 years ago students learned a lot about drugs that came from plants, and then we said we don't need that any more and we got rid of it, but it's coming back into the curricula. In my particular program—and I can only speak for it—we have a class that students do take. I know other programs are also adding course work, but I don't think it's uniform as yet.

Ms. Pauline Picard: Merci.

The Chair: Mr. Myers.

Mr. Lynn Myers (Waterloo—Wellington, Lib.): Thank you, Madam Chair. I wanted to thank the presenters this morning. It's very useful and helpful.

I wanted to ask NAPRA first— In terms of your summary of positions 1 through 9, I was interested specifically in number 7. That is with respect to a new organization within Health Canada. Is that in recognition of problems that exist now, or the perceived problems that exist within that area?

Ms. Barbara Wells: No.

Mr. Lynn Myers: So what's your point here in stating that?

Ms. Barbara Wells: We recognize that there isn't an identified centre of expertise in this area at the moment. There are foods, there are drugs—

Mr. Lynn Myers: I see your problem.

• 0950

Ms. Barbara Wells: It's something that's lacking in terms of the standing committee and this issue, but it hasn't surfaced for us as a big problem. It's just identifying a need that exists.

Mr. Lynn Myers: Thank you.

I want to go on to the labelling issues in your item 8. I think you later went on to talk about conditions of sale and such. Mr. Dunsdon also mentioned the need for pharmacists to be satisfied and the need for medical information and such. I wonder if you could develop that in terms of how you see that being in place to the satisfaction of both consumers and pharmacists.

Ms. Barbara Wells: Do you mean how number 8 would evolve?

Mr. Lynn Myers: I mean the conditions of sale on the labelling side and the pharmacists having good information to be able to advise people.

Dr. Linda Suveges: Maybe I can comment on that.

The scheduling model used for the non-prescription drugs is based on the prescription category and then what you do with the others. A schedule 2 drug is under the control of the pharmacist. A schedule 3 drug is out in the front of the pharmacy, but people can self-select.

The idea behind that is to provide for the need for more control. In other words, the health professional should be asking some questions, getting some information, and saying to the person asking for this product, “Yes, it's fine. Go ahead. You can obviously use this”—or whatever. If it is controlled within a pharmacy and not in other outlets and people have some questions, they can at least ask, because there's a health professional present.

We can apply that to the natural health products and have, let's say, three levels of risk: high, medium, and low. Low-risk products could be sold anywhere in any kind of outlet, with a special licence or whatever, if they were effectively labelled so people could understand what they're used for, how they should be used, and some appropriate precautions given. Perhaps the medium-risk products would be within some other kind of setting, maybe a pharmacy or something like that. High-risk products, even though they're very valuable products but have perhaps a narrow window of toxicity versus therapeutic benefit, might have to be prescription items or at least kept within the control of a health professional like the pharmacist.

So that's what we're talking about in conditions of sale. It's what happens to this product when it's kept in a certain place. Linked to that has to be what's on the label and whether you can sufficiently label something so people can look at it and say, “Yes, I fall into this category” or “No, I have diabetes and I really shouldn't take this product.”

We struggled over the right amount of information to put on the labels even with drugs so consumers could follow through with them in a safe fashion. I think we're saying those kinds of issues have to be dealt with for natural health products so people can select them.

Mr. Lynn Myers: Further to the point, I want to ask Mr. Te Brugge to respond to this. Are you advocating laboratory testing to determine safety, efficacy, and those kinds of issues with respect to any of these products?

Second, if you take the example of traditional Chinese medicine, how do you argue against those who would say, “We have 5,000 years of being able to use these products without having to worry about them or think they're harming people in any way”? How do you answer that? Maybe I'll ask NAPRA first and Mr. Te Brugge second.

Ms. Barbara Wells: We don't really have a position on efficacy, because our assumption is it would have been cleared through Health Canada. When our committee gets involved with scheduling, as Mr. Dunsdon said, it's safety rather than efficacy.

Mr. Warren Te Brugge: Opposition on that would be that at this time herbal products in particular are relatively unregulated in that there's a proliferation of products on the market. When herbal products were dropped from establishment licensing, it was almost perceived as a free-for-all.

Our position on that is that products should be tested and should meet certain levels. The GMP requirements must be maintained to ensure that people are receiving a high-quality product that is being manufactured in accordance with the correct practices.

• 0955

We do not believe that is onerous to the point at which it precludes competition. We believe it should be a requirement and it should be maintained.

As well, labelling should go to the level whereby it clearly identifies what the product is, what the components of the product are, but as far as its actual uses are, that should be done through education, both at a public level as well as at a level along with that product, with regulations set by Health Canada.

Currently, it's very difficult to do that, particularly with a DIN product, whereby you cannot make certain claims, or most claims, and therefore it's very difficult to in fact give the public the information they require in order to make an informed and educated decision.

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

Judy.

Ms. Judy Wasylycia-Leis (Winnipeg North Centre, NDP): I would like to direct my questioning to the representatives from NAPRA.

We appreciate the plan you presented. As I read your document, it seems to me that in the nub of your plan, the centrepiece or key recommendation is the development of some capacity, both within Health Canada and with the presence of an advisory committee, to have the necessary expertise to be able to play a meaningful role.

It seems to me that it's almost incidental to— Your recommendation of a third category doesn't necessarily flow from your plan, your recommendation. It seems to me that one could take your plan and apply it to a recommendation whereby we actually left the regulatory system in place and just adhered to the act. Or we could in fact accept one of the other recommendations made to this committee and have all natural health products deleted from the term “drugs” in the Food and Drugs Act. We could apply these mechanisms that have been suggested and accomplish the same end.

So I'm wondering if you could comment on whether you're totally wedded to the idea of a third category, or, if we had an agreement for this kind of approach to the issue, whether we couldn't move in either direction.

Ms. Barbara Wells: You're quite right that the drug scheduling model is not contingent on a third class. There were two separate issues. You're quite right that it's not necessary to have a third class in order for this model to be effective.

Ms. Judy Wasylycia-Leis: Related to that, can you give us any sense of how to weigh these three different options that are before the committee?

As for the third category, should we leave it as it is but apply the act and have the proper expertise with all this scientific surveillance and the labelling and the claims sorted out?

The next option would be to eliminate natural health products from the definition of drugs and put in place the necessary procedures.

Which of the three options do you think you would recommend?

Dr. Linda Suveges: I can make a stab at it. I'm not an expert on natural health products. As a pharmacist, I have some knowledge, but I would not consider myself to be an expert on the range of products out there.

I think the difficulty is that we are looking at things that range all the way from nutrients, which may be considered supplements, or individual things by themselves, through to products that resemble drugs, which would be easier probably to categorize. Then you can go all the way to things like the Chinese medicines, which are often a combination of many different kinds of components prepared a certain way.

I don't know whether you can lump all of those things into one of the categories. I think the advantage of having a a third class is that perhaps you could come to grips with that, whereas if you try to force them into the food and/or drug model, you may end up splitting them. In fact, maybe they're more like each other than they are like either food or drugs.

Mr. Jim Dunsdon: I'll add to that. We are, I think, inclined to support the idea of a third category by adapting the model that I believe we successfully applied to the drug products, with necessary modifications.

• 1000

With respect to Mr. Myers' question about going into a laboratory and testing, there may be some things, and there may happen to be low-risk products that you can't do that with, which would be an example of an adaptation of our basic model. There would be a need for other parameters to be applied there.

However, I guess our thesis is that the successful NDSAC model, which we've had a good experience with—admittedly we've had just three years of experience with it, but it has been a good experience. It occurred to us that the NDSAC model could be applied to this category of product, obviously with necessary adaptations.

So that would be the preference, although as Mrs. Wells says, it's not an absolute requirement that you have a third class. You could do those other things you were speculating about, but I guess what we're saying is that this would perhaps be a desirable option.

Ms. Judy Wasylycia-Leis: In just a quick follow-up, Mr. Te Brugge, you've made the statement that these products need to be categorized in a manner that does not confuse or mislead the public. What does that mean in terms of your preference with respect to regulatory mechanisms?

Mr. Warren Te Brugge: With respect to regulatory mechanisms, these products certainly are generally low-risk products and therefore do not really fit the design of what the category of drugs was designed to do. Neither do they fit where foods are. We believe there should be an adaptation or a combination of both of those, which would entail creating a separate category under which to administer and regulate these products, thereby creating a more level playing field across all sectors with respect to how the products are marketed.

The Chair: Ms. Caplan.

Ms. Elinor Caplan (Thornhill, Lib.): Thank you, Madam Chair.

It might be semantics, but it seems to me that it's not a third category but an alternative process that you're looking for to assess those things that look like a drug but aren't a drug, or are not purporting to be a drug, or that may be foods but are making a claim and are provided in a dosage form.

I'm concerned that the term “third category” is giving the wrong impression; what we're looking for is an alternative process so that we can determine what is safe for the public and whether the product is of good quality.

The part of your presentation that I'm concerned about is that you haven't addressed your views on what Health Canada's role should be in efficacy. You're saying you can get into your procedure after Health Canada has determined efficacy, and I think one of the questions for this committee, for a low-risk natural product, is this: what should be the regulator's role—Health Canada's role—in determining efficacy? Should it be held to the same standard as drugs? Do you want to answer?

I'll ask a second question while you're considering the first. If a product makes a claim, should it have to prove the claim? If so, what kind of proof should have to be provided? Is 5,000 years of experience or the fact that it's low-risk and hasn't killed anybody sufficient?

There are two good questions, I think.

Mr. Jim Dunsdon: They are good questions, and as you can see, we're pondering the answers. I'm not sure that anyone has a magic answer to those questions, with respect.

I'm reminded of the process of proprietary medicines. I don't want to throw another sort of spanner into the works here, but for many years the old patent medicine system was based on safety, safety, and safety. That was it. That was the mantra for patent medicines.

But then in the mid-seventies there was a change. It wasn't Health Canada at that time, but an equivalent organization, and it then ushered in proprietary medicines in the mid-seventies. There was an element of efficacy brought into that—not only the safety element. They were looking at how effective those products were and were trying to marry those two elements, but as soon as you got into that you were on the horns of a bit of a dilemma.

As I said a minute ago, we were quite anxious, for example, to hear what the Ontario health professions' regulatory advisory council said about naturopathy, because it did a very detailed work-up of that. Unhappily, we haven't yet seen the results.

Suffice it to say that there are a number of questions, but a lot of answers are missing, so to speak, with respect to this, and I guess we don't have the magic answer either.

• 1005

Ms. Elinor Caplan: If I could interrupt for one second, because we're short on time and she's a tough chair—

With the process you're proposing—and it is a process—provided we could get by the perception of independence and the need to ensure there is support of the stakeholder for this process, couldn't this do it, without having to go through the efficacy requirement first, if you were dealing with low-risk products?

Dr. Linda Suveges: Yes, it might.

Efficacy is an interesting issue. When a consumer comes to buy a product, even a drug, do they automatically think, well, this has to work, because somebody's selling it, and look at this, it's way out here, it must be safe? Well, of course we know that's not true, especially if they don't follow the instructions. Then you look at it and you say, well, people go on weird diets. They eat one thing for days on end. Can we protect them against that? The food is good, but it may not be appropriate for their health.

I don't know what line to take on efficacy. Certainly there are some times when a non-prescription medication has come to NDSAC and we've said, well, where are the efficacy studies? It has been around for a long time and the risks may be not as clear as we would like them to be. On the other hand, you balance that against, well, you know, it seems to work for some people, and it's not particularly a big risk, so shouldn't Canadian consumers have it available to them? That may be where we have to come down with this.

For things with high risk it doesn't matter how effective they are, unless you can regulate them in some way. For things with really low risk, when people are convinced they work, well, okay, isn't that all right too? Then perhaps in the middle you go through this process where you say these are the things we have to add to this, it might be labelling, it might be interaction with a health professional or someone else, and we have to add this information to it so it can be used safely.

Ms. Elinor Caplan: Have you considered the idea of a disclaimer, if you were going to go directly to this process you're proposing?

Dr. Linda Suveges: We had not thought about that. That's something that could be considered.

Mr. Jim Dunsdon: In an information letter that spoke to the subject back about eight or nine years ago there was a suggestion that labelling have a disclaimer on it that this has not been scientifically proven. That has been suggested, yes.

The Chair: Mr. Te Brugge, did you want to answer anything to that?

Mr. Warren Te Brugge: It is a pretty difficult question. Certainly the way we view things—and we do not manufacture any herbal products; we are specifically manufacturing vitamin and mineral supplementation—when we look at components—and we tend to look at things at a component level rather than at a product level—we do look for research, we do look for documentation, and we do look for references. So if we provide anybody any information on, for instance, vitamin C, we'll give them what the general basis for using vitamin C is, why it is effective, where it is effective, and then provide people with 20 or 30 references, or more, if they want, which they can actually get to and look at to determine on their own whether in fact it is as effective as we may have stated and make that decision on their own.

It is a difficult question, particularly when you're looking at anecdotal evidence, which is mostly the case when it comes to dealing with herbal products. However, extended use has proven that these are relatively low-risk. Therefore I would come back to the fact that we need to ensure education and educational material are available that can in fact be presented effectively with the regulations in place to allow people to make informed decisions rather than to rely on an individual to convince them otherwise.

The Chair: Now that you're already speaking, I'm going to ask you a question from one of the researchers here. You addressed the question of good manufacturing practices and you suggested our regulations need to be aligned with those of our international partners. Could you provide the committee with more information about the GMPs in other countries? Are Canadian GMPs required for natural health products more or less restrictive than those required elsewhere?

Mr. Warren Te Brugge: If we look at other countries— Let's look at our next-door neighbour, the United States. GMPs for natural health products in fact technically do not exist in the United States. They exist for pharmaceutical products, and certain companies agree, decide or choose to comply with those practices, as we do. However, not everybody is required to do that. We're not suggesting that should in fact be the case. What we're suggesting is that there should be a level of good manufacturing processes or practices in place, and they should be aligned to allow us to operate globally.

• 1010

If we look at Australia and New Zealand, we are relatively closely aligned. However, as an item that springs to mind in the area of competition, for instance, they have pieces of their regulation that allow small manufacturers to participate effectively. In Canada, though, it is extremely onerous from that perspective, in that all manufacturers are required to have a certain level or qualification of person doing the basic tasks on the GMPs. That is not cost-effective for a small company, because it is extremely expensive.

What it basically comes down to is that there is no small business exemption. How to deal with that in Canadian GMPs would be an example of that.

The Chair: Would you rate the cost-effectiveness for a small company as being ahead of the safety or interests of the consumer.

Mr. Warren Te Brugge: Definitely not. We believe safety comes first, but there are ways of achieving that safety while allowing other people and smaller companies to compete in that process.

The Chair: What would they be?

Mr. Warren Te Brugge: Particularly where a company is an offshoot of a company based in another country, that would include the idea that there has to be somewhere within that company an individual who is qualified to the level of the requirements. People in the smaller parts of the company—for instance, a company established in Canada—could then have an individual onboard who would report directly to that person, but who could also get the day-to-day tasks done in the cost-effective manner, such as receiving products and making sure they are sent out for testing. The actual interpretation of those test results should be able to be made through a person qualified not necessarily in that location, but perhaps at a head office location.

The Chair: Mr. Elley, did you have another question?

Mr. Reed Elley: I do have a question, but I'll defer to Ms. Carroll.

The Chair: Okay, go ahead.

Ms. Aileen Carroll (Barrie—Simcoe—Bradford, Lib.): I'll make mine brief.

Mr. Te Brugge, it just struck me that you mentioned that you came up to the issue of efficacy with regard to, say, vitamin C. As you say, you do manufacture and distribute vitamins and vitamin supplements. A recent study has received considerable attention in the media, and it was one in which I think several thousand nurses formed a control group and were given far more than the average amount of B6 and folic acid. I think this study was maintained for in excess of a dozen years, and the results of that study either appear to or actually do indicate a reduction in the incidence of heart disease in women when these two products are used. With that kind of study having been completed, I'm curious as to whether or not you as a manufacturer would feel that you could then include that kind of a result on the labelling of, say, B6 and folic acid.

Mr. Warren Te Brugge: Where studies of that nature have been conducted—and there are a number on such things as vitamin E, vitamin C, calcium supplementation, but we'll use your example—where we have a group that was studied in that manner using a double-blind placebo test like the one you referred to, we feel they do provide sufficient evidence to be able to make certain claims with respect to those components of those products. We believe that would assist the general public in making informed decisions, whereby they are referenced to those studies with respect to results and the benefits of specific components.

Ms. Aileen Carroll: It leaves me, as a member of the committee, with a dilemma in terms of when a study does reach an accepted level of criteria where, by sufficiently credible scientific standards or accepted medical practice studies, a manufacturer should be allowed to consider it as an appropriate recommendation within the realm of efficacy, and when it does not. I think we're struggling with some of this, so I just look for your input.

• 1015

Mr. Warren Te Brugge: We have a lot of debate ourselves on that. We have a group of 21 Ph.Ds on staff. We sit down during product and R and D discussions and get both sides of the story. Our biggest concern there, and I'm sure it is the concern of the committee, is that results cannot be taken out of context and need to be evaluated based on the context in which they were studied.

Therefore, if we are looking at a specific application for a particular product, we will look to studies whereby the criteria are met in that study. If they are not met, we will then generally—and this is speaking as an individual company in that we have the resources to do this—use parts of that study as a design for a clinical study that we will undergo to maybe test components or parts. For items that we feel were not tested, we will set up a study to actually test those.

Ms. Aileen Carroll: You do have your own R and D facilities, then.

Mr. Warren Te Brugge: Yes, we do. An example of our involvement would be the effectiveness of nutrition in assisting people who are HIV positive, and AIDS patients. We did not feel there was sufficient evidence out there that anybody had even taken the steps to study something of that nature, and therefore we initiated a study through the Community Research Initiative of Toronto, where we have 450 patients on a double-blind placebo study that will run over the next three years. It's been going about six months at this point.

Those are the steps that we feel are necessary to take in order to be able to say with any comfort that yes, you will achieve certain benefits and these are the benefits.

Ms. Aileen Carroll: Thank you.

The Chair: Mr. Elley.

Mr. Reed Elley: Thank you, Madam Chair.

Mr. Te Brugge, you're obviously a stakeholder in this from your company's standpoint. I'm wondering if I could put you on the spot a bit here and ask if you feel comfortable, for instance as a stakeholder, in vesting this kind of authority in a group like NDSAC, knowing now something of what they're suggesting. How do you feel about it?

Mr. Warren Te Brugge: Frankly, I'm a supporter of that type of process, and we are, as a company. We believe that at this point in time the government is not able to achieve its own objectives within Health Canada because it is focusing a tremendous amount of effort on trying to ineffectively police a very wide range of marketers, shall we say, or participants in the industry.

I think that through the joint— In my introduction I mentioned that it need not necessarily be a specific association that has the power, but that associations in general that deal with the different segments of the market do have that authority to act on those complaints to create more of a level playing field.

We believe there is an issue with respect to a level playing field, and that there are sectors of the market that are unregulated to the extent that Health Canada can't reach them because they do not have the resources to do so. Therefore claims are made, products are produced that are not of high quality, and the public is generally misled. So we would support moving that authority down from a government level to an industry level, yes.

Mr. Reed Elley: So you would be comfortable, then, with NDSAC, utilizing their expertise—

Mr. Warren Te Brugge: We're not necessarily comfortable with NDSAC, but something of that nature, yes.

Mr. Reed Elley: Okay, well, that's what I want to hear, and we need to hear that. But you would be comfortable utilizing some group like NDSAC who has some expertise already in this area with pharmaceuticals, only with a component of people like yourself and others in the natural health food product area working with them in in this area, with an expanded framework. You're saying you feel good about that.

Mr. Warren Te Brugge: Yes, I do. I feel that would create fairness in the marketplace.

Mr. Reed Elley: And would this give you the kind of self-regulatory aspect that I think you're looking for? You're saying you can see the industry in some way providing its own regulations on this?

Mr. Warren Te Brugge: I still believe that regulation needs to be determined by government. In my mind, that should never change. However, I believe that the compliance issues and the actual enforcement of those regulations can be done effectively at an industry level, yes.

Mr. Reed Elley: Thank you.

• 1020

The Chair: Thank you.

Ms. Caplan, would you like to have the floor?

Ms. Elinor Caplan: Yes. I would like to pursue, if we could, this alternative process and what, if anything, you see as Health Canada's role. If we agree that we need an alternative process for those products about which Health Canada today is saying—I think this is a fair statement—“If it looks like a drug, makes a claim like a drug, then it is a drug and should be treated like a drug”— We're hearing from a whole lot of other folks who say that just because it looks like a drug, if it's not a synthetic product, it's not a drug. That's kind of how I see the two sides of this debate.

We're dealing with those things that a whole lot of people are saying are not drugs, that they should be foods or something else—natural health products. What do you think Health Canada's role should be?

Mr. Warren Te Brugge: I'm going to jump in first. Our view there is that Health Canada's role should be still to ensure that products are licensed.

Ms. Elinor Caplan: Licensed for what? I mean, you say, “Here's a product I want to manufacture. Give me a licence.” “Okay.” What does that licence mean?

Mr. Warren Te Brugge: I believe the licence should have a number of components. The licence should include identification—the actual components and identification of those components as to their efficacy and their effectiveness, based on research that should be presented—as well as labelling and marketing practices. There should be regulation, and the government should be involved to that level. If they are not, we get into a situation whereby there is the potential for the public to be misled as to what is actually in the bottle.

Ms. Elinor Caplan: Let me just pursue this. What I've heard you say is that you think Health Canada has a role in ensuring that what you say is in the bottle is actually in the bottle, and secondly, that the product is of good quality because it's been adhering to the GMP—good manufacturing practice. Am I right?

Mr. Warren Te Brugge: Correct.

Ms. Elinor Caplan: Efficacy—if it's a natural health product, should the level of efficacy be related to the claim it's making, or should it be related...? I mean, that's where you're on slippery slopes now, I think. What should Health Canada's role be with a product that meets good manufacturing practice standards, where they can show that what's in the bottle is actually in the bottle, so it's safe, and it's low-risk, and they don't want to make a claim? There is the dosage, but they're not making a claim.

Mr. Warren Te Brugge: As long as they're not making a claim, then the person is using that product based on their own choice. Where people are making claims, however, we need to set standards as to what those claims can be.

Ms. Elinor Caplan: So the question is the standard of what the claim can be, or the standard of if you make...? There are different kinds of claims. You can say “cure for” or just “for sore feet”.

Mr. Warren Te Brugge: I still agree with the current stance of Health Canada, which is “it isn't a cure for anything”. I think these kinds of products provide people with the opportunity to improve their general well-being. I do not believe that any of them should be allowed to make a claim or misinform somebody that they can cure anything in particular.

Ms. Elinor Caplan: Then the question is how much evidence should you have to provide to meet the claim you are making?

Does anybody else want to comment on that?

Dr. Linda Suveges: I think that is a question that I struggle with myself. I'm a scientist, so I can understand the placebo control, double-blind studies, and those are great. It shows me something if they've got enough people, etc.

The ones I have less familiarity with, but in a way still want to trust, are the “500 years or 5,000 years of this has worked, and gee, you know, look at that. They put it on my rash and it made it go away, so something happened.” I guess I don't know in my mind what to do about those. I agree that perhaps words like “cure” should not be in the vocabulary. I don't know whether we can cover all of the claims that might be made—and that would be for low-risk products.

• 1025

For anything higher than low risk, I think we have to talk a different kind of situation, because they have to be able to prove efficacy, and that's just the way it is. If you cannot prove it in a suitable way, it's not on the market, as it were, in one of these categories. But I don't really know the answer to the question as to what we should do with low-risk products where people want to be able to say that this is what it does.

The alternate is, if we don't put something out there on the label or we don't have a process, what happens is consumers hear via the ether that this works. Then we all go and try it, and we figure out a way to get it, even if it's not available in Canada. So that's also something we want to hold out again.

I would hope the producers of these products would like to have some kind of structure. I would think it's an advantage to them. If we won't classify it as a food substance and we don't want to classify it as a drug per se, if we keep the same definition of a drug, surely it is to their advantage to be able to call it something and to say it has met some kind of structure.

That was kind of wishy-washy; I don't think I answered your question.

The Chair: Mr. Volpe.

Mr. Joseph Volpe (Eglinton—Lawrence, Lib.): Following that line of thinking, I would ask you to focus for a moment on the role of Health Canada in this question of having producers, in addition to following these other regulations, indicate what the outcomes might be of use of a particular product, keeping in mind that many of these products are used for off-label indications.

I hope I am choosing my words carefully. I don't want to discredit anyone.

It is one thing for us to say this is what the product does and this is what the outcome might be if you take it in this dosage, but in many of the therapies that are being indicated by practitioners today in complementary and alternative medicines, they really use two or three or four or five, and sometimes more, of these herbal products, and in some cases very defined products.

How do you propose we deal with that? Or should we deal with that?

Dr. Linda Suveges: This happens with drugs, which, of course, I am more familiar with, where people will not follow the advice that's given either on the label or from any health professional, and they'll just do whatever they want. I guess the question is, can you protect every person from themselves? Of course, the answer is no. Health Canada has to find a way to say that this is relative safety or risk, providing people put it together in the right way and follow advice.

• 1030

I don't know if you're ever going to be able to protect against someone who may be taking a combination or doing it in other than recommended doses. All you can do is say were they to do that, what are the implications? If they were to take even a little more or they were to mix it with something else and it's dangerous, that makes it a high-risk product, even though by itself, perhaps, it's lower-risk.

So I think you have to ask some of those questions from the consumer perspective and ask what is likely to happen out here. If you can predict that the likelihood is this and you have evidence it's going to be a problem, you have to deal with it as a higher risk.

Mr. Joseph Volpe: What do you do with traditional Chinese medicine, where a practitioner of TCM will typically give a patient five or six, maybe more, individual products, all herbal or natural, but in combination they produce a particular impact?

Dr. Linda Suveges: I'm not at all familiar with that area and I don't think I can comment. I guess if it were presented to me— This is where the model we're suggesting— Obviously the individuals we have on our particular committee are not the right people. They may be contributors in some fashion, but we also need to have the kind of individual or individuals who have explored that and connected it to the other kind, the biomedical or western medicine, so everybody can understand the perspective. We don't have just one system working any more, so you have to have those two people or groups communicating and saying, well, this is what is happening. Then you can put the two together. As an individual I don't feel qualified to do that, but a group could.

Ms. Elinor Caplan: So is there agreement that Health Canada will be determining level of risk? In other words, is that an appropriate role for Health Canada...if a product is high risk or low risk, and then perhaps to determine the process?

Dr. Linda Suveges: I think an advisory kind of group, this committee, NDSAC or something like it, could contribute to that. You might need to take advice or evidence from several sources. Certainly submissions to Health Canada would be one. Working with some kind of advisory group such as NDSAC could also be helpful to that process.

Mr. Warren Te Brugge: I would agree with that, and currently Health Canada does that. They go through the process. I've attended too many meetings getting input, and certainly members of our company and other companies that work in the same area as us, on determining risk. It is something that shouldn't be decided on their own, so to speak.

Ms. Elinor Caplan: On their own by...?

Mr. Warren Te Brugge: In other words, Health Canada unilaterally making a decision that this is what the efficacy or the risk of this product is without taking input from interested parties and other stakeholders.

Mr. Jim Dunsdon: There are two risk elements here. There's the marketing risk, if you will, where Health Canada— I'm referring to our brief. It shows where the components Health Canada would be involved in would be application for licence, review of application, marketing approval—that's a risk process—and then the NDSAC or a like process could focus on the conditions of sale, again based on relative risk, high, medium, or low. It's a linking, in a way, of those two things, as I see it.

Ms. Elinor Caplan: I just want to say how helpful the presentations have been in helping us get our minds around some of the nuances and the differences. It's interesting and helpful to have some solutions proposed. I do find it frustrating that you're struggling with the same difficulties as the committee is. If you do happen to think of some answers to some of the questions that were asked and you would like to submit them to the committee, you could send them to the clerk and he will distribute them to the committee.

Thank you.

The Chair: I thank you again, on behalf of the whole committee, for coming and for having some ideas for us. We've heard a lot of complaints, but what we need is suggestions for where we're going to go.

We'll take a break while we change chairs here and put the new group on.

• 1035

• 1047

The Chair: I call the meeting back to order.

We have three groups with this session of an hour and a half.

We have two individuals from Health House. Andrew Boychuk, welcome. Dr. Jennifer Armstrong is an expert on environmental medicine.

From the Department of Nutritional Sciences of the University of Toronto, we have Harvey Anderson, Venket Rao, Dr. David Jenkins, and Peter Shin.

Mr. Boychuk, we'll start with you. As was suggested with the other group, we really would like some ideas so we can start zeroing in on what kinds of conclusions we're going to come to.

Mr. Andrew Boychuk (Researcher, Health House): First, I would like to say I speak from the perspective of a researcher, but first of all, I'm a patient in dire need of certain health care products. We don't have any affiliation with any companies or any businesses as such.

Health House was conceived by a small group of us for the purpose of somewhat improving the science of looking after human health, perfecting it. We call it health management.

You know that most people don't even know what we're talking about when we say that. People don't think of looking after their own health.

This means all the things we do, like eating, sleeping, exercise, keeping clean, and yes, going to the toilet, and that is quite a considerable science.

I don't know if I should mention to you what health is, but I'll just go over it briefly. Health means the optimal functioning of all organ systems and the absence of infectious diseases.

Some people just simply, even professionals, consider the absence of a raging disease as being healthy, but no, I think health should be that we function at our very best that we can.

• 1050

I won't belabour you very much with all this that I've written. You can read it for yourself.

I will go right to the core of the problem of regulation. It is quite evident that our health care industry is controlled by the pharmaceuticals, and this definitely is not very good. They don't have a...it's a biased view so how can they really govern the health care industry in any way?

Plus, I think that any meaningful move that we would want to make to confirm this would have to mean that the health care industry should control itself, and from what I know of the health care industry, they certainly have some very competent people, and if not, this can be easily arranged. It is important to the health of the nation.

There are people flocking to the health care stores and health food stores to find help, but they don't really know. Some know they need supplements that are a little fancier and these are probably a little more helpful and more efficacious. It is these the drug industry wants to remove.

We should not permit this. If the government feels that the health care industry needs regulation, it should lay down the guidelines if they're not satisfactory now. I feel it would be worthwhile to give them the money necessary to establish such a body; of course not from the side of anybody from the pharmaceuticals or from the medical side. The members would have to come from people who are trained to look after health, because the science is very much different from medical care.

If I could have your patience, I would just like to tell you a little about my experience with the drugs, just to give you an idea. I had a heart bypass in 1985 and was also placed on aspirin, or Entrophen, one each day, permanently, so to speak.

After two years I realized that I was doing very badly. I was having all kinds of problems all over the place and I was getting to be like an old man. So eventually, contrary to the advice of doctors, I said I'd rather be healthy than dead so I went to find another solution. I stopped taking it, and naturally, of course, my health improved.

With that considerable improvement, I got encouraged and said that I'd better get a little more educated on health, so I entered college and I started to learn about it. I did a fair amount in order to have a much better understanding of health and how to manage it.

The consequence of that was that in the end— Some of the problems I had while I was taking this Entrophen were ulceration of the stomach in the duodenum, psoriasis, plantar fascitis on both feet, tinnitis, polyuria, frequent headaches, and neuralgia. I had no pep. I was slipping and tripping and falling all over the place, twisting my ankles. I couldn't skate and I couldn't throw a ball, and I was a baseball pitcher so I wanted to pitch. When I told him I wanted to still play ball my cardiologist said, “I hope you're not going to pitch.”

• 1055

I assure you that today, at 70, I can pitch much better than I ever did in my prime. I just thought about it the other day. I hardly ever slip. I haven't fallen. I don't trip around. I don't twist my ankles—that happened to me very frequently. I don't wear glasses. I walk around like a mountain deer. I feel like walking. I feel like running. This is at 70, when I couldn't do it at barely 60. At this point I'm not yet a highly professional researcher or health expert. I accomplished this by merely looking after my own health.

As we got more skilled in the use of nutrients, we found we could do even fancier tricks by using amino acids. This field of amino acids is apparently not very well exploited and there are many various ideas about it amongst doctors. I have found that doctors don't even have on their list of tests the provision for an evaluation of your amino acid status, and that is very important to your health.

I got some very excellent books and fortunately am a very excellent researcher. I became quite at home with supplementing the individual amino acids, but I have to get them illegally on the black market. I think I should be able to get them legally. I applied to Health Canada for a permit to get them and I haven't heard from it, so I gather it's waiting for permission from the drug companies.

I have found they have excellent benefits. Since I have been practising this science, I can run and not feel a tightness in my chest, particularly on a cold day, so it must be having considerable effect. I feel I should have the right to have this.

The Chair: Mr. Boychuk, could you try to wrap it up in a minute or so, so we can get to the questions?

Mr. Andrew Boychuk: Yes. I'm about at the last minute.

Just to give you a little more of the flavour, at one point as I got healthier I started getting friskier. I forced myself too hard and got fibrillation. I went to the hospital, to emergency, to get defibrillated and it was quite an ordeal.

The next time, I thought, I have what I need here so I'm going to defibrillate myself, and I have done so three times. Of course, by now I know to handle my own fibrillation without having to defibrillate myself.

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Well, an awful lot of people are going to the hospital for just such things. We would never think we could do it ourselves.

I just want you to have the flavour of what it can do for you. It not only helps you to stand on your own feet and to help yourself become better, it's a great confidence booster and relaxant, if you wish.

I should add one more thing. Although it's well known, I should let you know that it is quite serious. The pharmaceuticals are very shamelessly trying to seduce our young mothers into not giving the child the best nourishment; that is, breast-feeding them. This is a thing I promised I would mention here.

The Chair: Thank you very much, Mr. Boychuk. You'll probably get a chance to talk some more in the questioning.

Dr. Armstrong.

Dr. Jennifer Armstrong (Individual Presentation): Madam Chairman, first let me thank you for inviting me today. I would like to commend the panel members for their excellent interim report, even though I don't agree with every point.

I'm a physician specializing in environmental illness—what we call “EI”—chronic fatigue, fibromyalgia, and allergies. Although I focus on these ailments, I am here to protect the rights of all Canadian patients, whatever their illness.

Nonetheless, I would like to point out that environmental illness has reached epidemic proportions in Canada. It is the new plague for the new millennium, and it's going to get far worse before it gets better.

Vitamins and minerals are a mandatory part of my practice. Prescription medications are only one option. My patients are getting better without them. I might add that I did as well.

For six years I battled with environmental illness. It was hell. I fought back successfully. My personal experience was a dramatic eye-opener. In order to recover, I had to explore and utilize alternative services and complementary products. Nutraceuticals—that's the word you use—were a prime key to my recovery. Now nutraceuticals are a prime key to the recovery of my patients.

In response to the interim report, I would like to pose a few questions.

The Chair: I will interrupt you to let you know we are not the advisory panel. This is a permanent committee in the House of Commons. The advisory panel has come out with an interim report. They are also coming to let us know what is on their report.

Dr. Jennifer Armstrong: I'm sorry.

The Chair: We're here doing a permanent— —Yes?

Ms. Aileen Carroll: We read your submission before you gave it, and although indeed the chair is correct, it seems to me you still do raise some issues that are worthy of our consideration.

The Chair: I'm not going to stop her. I'm just letting her know.

Go ahead.

Dr. Jennifer Armstrong: I was just wondering how the government would monitor all the companies, Canadian and foreign, for good manufacturing practices. How would the government know if each labelled product is actually pure or is what it says it is? Would they be doing any testing in their own labs? Does the government have the manpower to regulate nutraceuticals to the extent outlined in the report?

I was wondering if there was any way of monitoring the nutraceuticals other than the ways we've been discussing today. I was wondering if perhaps there could be a physician and complementary practitioners and educators' monitoring registry.

I was wondering how rigid the government could be in its regulations. Just one example for food products was that milk has been strongly linked to insulin-dependent diabetes, yet we don't currently regulate milk or educate the public on that issue.

I would also like to voice the following concerns. My first concern is that we have hypo-allergenic vitamins and minerals available for my most sensitive patients. The hypo-allergenic products I generally use cannot be found in health food stores, or it's difficult to know the quality of those in health food stores, so sometimes I have to order products from United States suppliers, and products about which I know, even from testing all of them on myself, that they are good. I'm concerned the regulation may limit the supply of some of these pure and excellent products.

My second concern is the likelihood of prohibitive costs associated with nutraceutical licensing.

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A corollary concern relates to my patients' needs and specific situations.

Generally, by the time they get to me, my patients have been ill for between 5 to 15 years. Most of them have seen dozens of doctors, dentists, and complementary practitioners. They have spent as much as $100,000 on their health needs without getting substantially better. It is already a challenge for them to afford the pure products that I recommend, and I would hope that careful consideration be given to the cost of the lengthy healing process of environmental illness, fibromyalgia, and chronic fatigue. We do not want to increase the stress on these already stressed-out patients.

Lastly, a wide educational campaign is in order to help Canadians make informed choices on the benefits of nutraceuticals, whether high, medium, or low risk.

In conclusion, I hope the final report of this panel will include recommendations on a broad-based educational program for physicians and pharmacists, as well as all Canadians, from grade school onward. I would be honoured to serve on any panel or task force whose goal is to educate Canadians fully on the benefits of good nutrition and the wise and appropriate use of nutraceuticals.

In support of my perspective, I'm including a list of key research books, which are right here if anybody wants to look at them: Nutritional Therapy and Medical Practice, by Drs. Alan Gaby and Jonathan Wright; Nutritional Influences on Illness, by Melvyn Werbach; and Mental and Elemental Nutrients, by Dr. Carl Pfeiffer. There's also a case report on a patient who cured her schizophrenia using nutritional products and a healthy diet.

Thank you very much, Madam Chairman.

The Chair: Thank you very much, Dr. Armstrong.

I don't know who's going to start from the other group. Mr. Anderson.

Dr. G. Harvey Anderson (Professor, Nutritional Sciences and Physiology, and Co-Director, Program in Food Safety, Department of Nutritional Sciences, University of Toronto): Thank you, Madam Chair.

Perhaps Mr. Volpe, as a teacher, would appreciate how we sort of feel. The definition of an expert and a teacher is one who's out of town and has a set of slides. We have overheads, but we don't have an overhead projector, so we will carry on. It might be just as well he doesn't see my overheads, because they might not be in the best teaching mode.

You have a handout that I won't refer to directly, but I'd like to present to you why we are here, what we do, and who we are, of course, and how we might be able to help and what our suggestions are, in line with your earlier question.

I'm a professor in nutritional sciences and physiology in the faculty of medicine at the University of Toronto. With me is Dr. David Jenkins, who is a professor in nutritional sciences and medicine and director of the clinical nutrition and risk factor modification unit at St. Michael's Hospital, so I'm sure he'll answer well the question of risk and benefit; and Dr. Venket Rao, who is a professor and co-director of the Program in Food Safety, with me. The reason they're here is because they both do work in the functional food, nutraceutical, food components, and health area. Their research is based on that, and that's what we wish to discuss.

Also with me is Peter Shin, who is manager of the University-Industry Affiliates Office, which I want to describe briefly.

The Program in Food Safety, which we co-direct, has as its purpose to address the scientific basis of food safety, nutrition, health, and regulatory issues confronted by the food industry, government regulators, health professionals, and consumers. We're unique in being academic and university-based. Most academics don't pay much attention to regulatory and other issues, I think it's fair to say, because it doesn't have quite the research interest that we generally have.

However, we had proposed such a program and received funding in order to develop the proper partnerships to tackle some of those problems. We're funded by the Natural Sciences and Engineering Research Council, which is one of Canada's granting bodies, as I'm sure you know; members of the food industry; and the University of Toronto.

So that you understand who, at the moment, funds our affiliates program and our activities, we have 15 members, ranging from: the Canadian Sugar Institute, Canada Bread Company, Dairy Farmers of Canada, General Mills Canada; a number of the multinationals—Mead Johnson, Monsanto Life Sciences, Nestlé Canada, Procter & Gamble, and so on. However, when Dr. Jenkins speaks, you will also recognize that many of the small industry who would be affected by nutraceutical and functional food regulations are also reflected in the research and our interest within the department.

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As for the academic members, it's not just the University of Toronto. We have members from the University of Guelph's Food Council—we link with them in research and programmatic studies—and from Ryerson Polytechnic University.

We have two components, again reflecting that this is an academic program. As a result of this partnership—the industry support along with NSERC—we have created a chair in the department of nutritional sciences, a research chair, which is focused on nutritional toxicology. Then we have the university affiliates office, which Peter Shin runs, where we try to target scientific problems of common interest to the academic community, the industry, and government.

Our goal as a program is to enhance research in the academic setting, increase partnership with the private sector, and increase partnership with the government. The bottom line, of course, is that our interest is in the public health of Canadians, particularly appropriate dietary guidance.

So why are we here? Well, we want to discuss with you—and certainly this will be expanded in the question period—the rationale for regulated health claims for food and functional food components. As you know, we don't have that at the present time. Many countries do.

Perhaps you look at us and say we're the conservative nutritional scientists. Well, things have changed. We recognize that there's more to vitamins, minerals, and food components than simply providing nutrients for the maintenance of health or for the traditional functions we see, and some have been mentioned this morning.

In the department, dietary fibre, lycopene, vitamins, minerals, plant components, and phyto-estrogens are all active research areas because of their importance to health and prevention. Particularly our interest is in the prevention of disease, not its treatment.

In that context we would like to support the initiatives undertaken by the therapeutic products program and the food directorate in their development of the policy options analysis on nutraceuticals and functional foods, which is the report that has been referred to. Dr. Jenkins was on the advisory body and I was part of the consultation process they held, which came up with a strong option that is under consideration. We'd like to see Health Canada get on with this, and therefore we strongly encourage that Health Canada permit structural, functional, risk reduction, and therapeutic claims for foods and food components. Nutraceuticals certainly are in the definition of food components.

We of course want to share our expertise in developing scientific standards for health claims, something that was discussed earlier.

So just to summarize our point of view, we are in favour of health claims to guide Canadians to healthier diets. The issue in regulation is the claim—not the definition of the product or component, but can it meet the standard for the health claim?

Health claims need to be regulated. They can be very useful to Canadians to achieve a healthier diet and to prevent disease. They should be based on scientific evidence that is appropriate for foods and food components, but they should not be regulated as drugs. In other words, the risk issues should be discussed versus the benefits. That's something that needs to be expanded upon.

With that I'll close my remarks and turn to Dr. Jenkins and Dr. Rao. Maybe they can have a couple of minutes for comments.

Dr. David Jenkins (Professor of Nutritional Sciences and Medicine, Department of Nutritional Sciences, University of Toronto; Director, Clinical Nutrition and Risk Factor Modification Centre): Thank you. David Jenkins here.

I'm sorry. My colleagues have been joking that had I been following a better diet, I'd be in better shape to talk to you. Possibly the regulations that are going to be set in motion will make this better in the years to come.

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My interest in this is a long one, as is Dr. Rao's. For many years we've been trying to encourage industry to produce foods that actually have functional characteristics. I think that's important, and I think we're probably all agreed that as we enter a period where the demography is such that we will have an aging population, chronic disease and the burden of chronic disease, cardiovascular disease, diabetes, cancer, are going to continue in terms of their cost, in terms of suffering and in terms of economic cost. We have to think of strategies that are a little bit different from telling people just to eat a good diet.

One of the things we believe is important is that if we can get the food industry to work in this direction we may achieve a great deal. We would do two things. We would empower the ordinary citizen, hopefully, to take more control of their own affairs, and it makes good economic sense, both at home and in terms of exports because Canada is a great producer of raw materials, whether it's ginseng, whether it's soy, whether it's things that are required in the orient, whether it's high-quality beta glucan from oats that may lower serum cholesterol—all these things. Whatever it is, we can produce it. We have companies in Canada that are actually trying, not very successfully, because we have no health claims ability— So they look to other markets. Some of them look to factories that are offshore.

We have the materials. We have a public who need this. I think what we need is the form of legislation Dr. Anderson was talking about. In other words, if Health Canada's current initiative could be brought forward and escalated so that in fact health claims could be made that could be of some incentive to companies to enter this particular area and get good returns for their investment, because I think that's very important, then I think we could launch this. I think the ability to save suffering and to make an economic success would be enormous. That's why I, who am based both in the nutritional sciences and in a hospital, feel that this is a crucial part of the area that I would like to see promoted.

I don't want to go into any more details now, merely to say that I've worked with companies that are large and small and there are major barriers. If you feel those should be discussed, I'd be happy to discuss them. I've worked with companies that have been large, like Loblaws, but they also encompass many small companies who contribute to them. In fact, it was to service these needs that Loblaws put out the “Too Good to be True” product line. If any of you go in and look at this line, you'll understand what I mean. But it was with us that they developed these.

So these are the sorts of initiatives that I want to see much more of in Canada, because I think we're capable of it. But we're not capable of doing it with the current regulatory environment, and I think that's the situation we're faced with. That's why I think the progress that's being made with what used to be HPB, with Health Canada, in terms of coming up with an initiative and some rank choices for a structured approach, which can cover foods, nutraceuticals, functional foods, which I think could do an umbrella job, is important at this point. It's important to do it quickly before we lose out on the opportunity.

Thank you.

The Chair: Mr. Rao.

Dr. A. Venket Rao (Professor, Nutritional Sciences; Co-Director, Program in Food Safety, Department of Nutritional Sciences, University of Toronto): Thank you, Madam Chairman.

I don't have that much more to add, other than what my colleagues have already stated. I do agree that the discipline of nutrition has come to a stage where we are now looking more at these components in food and playing an increasing role in terms of maintaining good health, as well as prevention of disease. I think the point has already been made that the policy options report looking at this has come up with some guidelines. As Dr. Anderson has pointed out, we support that, and I believe the three points have been made that we do believe foods should be allowed to have health claims, that there should be directives and regulations, and that guidelines should be developed based on science as to what constitutes the efficacy as well as how the claims can be made.

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In addition to that, of course, the point that's also made is that we already have regulations, so we really don't need any additional class of regulations to deal with these. Truly, we're indeed dealing with foods, and these are soya beans, as Dr. Jenkins has mentioned, or tomatoes or flax or whatever. These are foods we're talking about and I think they should be regulated as such.

I believe that once these health claims are permitted, we'll have a better informed public. We would serve the public health mandate in terms of how people would have more health choices, based on the information provided and the claims that are made, and we would be serving the public health interest as well. So I support all three aspects of that.

I thank you very much.

The Chair: Thank you very much, all of you. We'll now go to the members for their questions.

Mr. Elley.

Mr. Reed Elley: Thank you, Madam Chair. Once again I want to thank all of you for coming here today and adding your own particular perspective to the questions that we're asking about this whole issue.

I'd like to go back to something that I've raised at this committee before. It has to do with the labelling of foods and their safety.

For instance, we've had a number of people from the natural food industry and natural health industry talk to us about their concerns if, for instance, very strict regulations go into place for a product like garlic. Now you can go and buy it in the store and ingest it as a food and there's no problem with that, but they're concerned that if you start breaking it down, mashing it up, putting it in a capsule, putting it in a bottle and labelling it, you might then enter into some other kind of regime. We're talking about having to put things like health claims and this sort of thing on the label.

So there's that kind of food and then there's peanut butter. I have a child who is very highly allergic to peanut butter. If she even smells the stuff she goes into that anaphylactic kind of reaction. But we don't ever label peanut butter. I haven't picked up a peanut butter jar at Loblaws and seen a label that says “This can cause death”.

So what is the role of government in this? How does government regulate something that is a food but obviously has some kind of effect on us? Would anyone like to tackle that one?

Dr. David Jenkins: Thank you. I think that's obviously a key question. Hopefully it will be regulated with a good dose of common sense as well.

For example, there are currently regulations for fibre and laxation, and there are some new fibre products, ground pea hulls or whatever, that may be getting into the bread supply. Health Canada already had to wrestle with that and decide whether the material is efficacious and has some laxative effect and whether on balance it's likely to cause any harm.

On balance, they've considered that it doesn't cause any harm, and so without an enormous amount more to do, in the eighties that sort of material was permitted. We've had no negative feedback from that since.

So hopefully things like garlic and soya components...and if there seems to be no reason, I think some common sense has to be used in these situations. If there's no particular reason for concern, then we may have no concerns, and I think it would be reasonable to show no concern.

One of the things we're talking about here, though, is that we're talking about materials that may have a very low therapeutic gain in comparison to drugs. Similarly, we would expect them to have a very low toxicity index. In other words, we would expect them to be low on both sides.

But applied over a population they may make a very important difference in terms of health for people in general.

So I would agree with you. I think this is going to be a grey area, but it's one where I don't think you can look around all the corners at every particular product that's going to come up, because fortunately science is expanding and we're getting new products on the market and we're getting new ideas. Epidemiologists are coming up with new concepts that we have to adapt to.

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I don't think we'll ever be able to write the final regulation today. I think what's important is that we should set in motion a process and start feeling our feet with it.

Mr. Reed Elley: Thank you. Can I ask the same question—

The Chair: First, Professor Anderson.

Dr. Harvey Anderson: We were talking about the reduction of chronic disease, such as heart disease and cancers, and making health claims on foods that will prevent that process and create a healthier population.

We're now developing strategies aimed at population health. When you start to refer to something where you have a strong allergenic response in individuals in the population, to me those are two different levels of the question. What guidance and information a person needs to prevent that response is different from what we're talking about, such as health claims and benefits. If you can enhance something in the food supply and can create a healthier diet for people, we need to be able to direct them toward creating a healthier diet in order to prevent chronic diseases.

Mr. Reed Elley: Can you address those two issues? They are two separate things, in a sense. How does government address those two issues in regulation?

Mr. Peter Shin (Program Manager, University-Industry Affiliates Office, Program in Food Safety, University of Toronto): Look at the peanut issue. It's mandatory for all food products to list their ingredients. So if we're looking at an allergy for peanuts, it will be listed in the ingredients section.

As Professor Anderson mentioned, the point we're trying to make is that these products are for the general population; we're not talking about specific individuals. We're hoping that these messages, based on the science that has been done so far and that will continue to be done, will hopefully benefit the population.

So in terms of allergies, I think Health Canada has assured, or tried to educate, the population by telling people to look at the list of ingredients. By having some sort of warning that this product may cause death, I think a lot of people may have second thoughts about buying peanut butter the next time they go to the supermarket.

Mr. Reed Elley: Dr. Armstrong, in your practice, how do you see government regulating these kinds of things?

Dr. Jennifer Armstrong: Well, actually, one of the concerns with any product our patients take is allergies. It's not just peanuts, but dairy, wheat, and corn products. We find that citrus products cause the most common allergies. Sometimes products don't list dairy ingredients when these ingredients are in them. So we have major concerns about the allergic components of products, whether they're supplements or food.

So when it comes to regulating them, I think the most important part that we can see for our patients is that they're well labelled and that everything is disclosed, including the additives.

They do that in drugs. It's done. When I open my CPS, I can see that everything is there. If there are any questions, I can usually ask the pharmacist, and he can help me with that.

But when it comes to the other supplements, you don't know what process they used to manufacture them. With primrose oil, sometimes they use a solvent to extract it, yet some patients can't tolerate that oil because of the solvent. So it would be nice to know all these different factors for our patients, but I don't know how.

I think labelling would be important, yes, but I'm not sure how much more is actually necessary to ensure that the patients are safe. Yes, good manufacturing principles are good, but when it comes to claims in efficacy, there are a lot of studies here on the efficacy of different vitamins and minerals. I'm mostly concerned with vitamins and minerals. But there are multiple reasons a person can take vitamin B6, not just cardiac reasons.

So those are the things that concern me. If someone has to start making claims for their product, it's going to be a pretty long list, so maybe an educational process would be more easily instituted.

The Chair: Thank you.

Madame Picard.

[Translation]

Ms. Pauline Picard: Hello. A few moments ago, another group of witnesses recommended that we invest more in clinical testing for nutritional products. Does your university group currently have any financial support to continue its research? Secondly, do you think that Health Canada currently has the necessary expertise to demonstrate the safety of natural products and to develop new rules that would satisfy natural product consumers?

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[English]

Dr. Harvey Anderson: It's a very nice suggestion. If you would suggest more money for research, we'd love it.

In fact, the NSERC University-Industry and University-Government programs provide some modest support in that direction and it certainly needs to be encouraged. Dr. Jenkins has been a strong advocate and has one of the few programs in Canada that is trying to look at plants and components of foods and show their benefits through clinical trials or human experimentation that lead to health claims.

I also think we are starting to appreciate that there is a much closer link to the knowledge base pharmacists need with respect to nutrition than we have in the past. At the University of Toronto we give some lectures in pharmacy. The University of Saskatchewan has the school of pharmacy and nutrition, so recognition is emerging. We want to have more effective collaborative research programs, but it's hard to do that effectively without having the private sector involved as well.

Dr. David Jenkins: I would agree entirely. I think we need to encourage the granting agencies to look at this as a very serious aspect of research because it's an area we've neglected badly, in general. Once one has the knowledge, it makes one's educational programs that much more meaningful. So I think they go hand in hand.

Dr. Venket Rao: You can see how sensitive we are to the issue of research. Many times this has fallen between the cracks because of questions about whether it is basic science, health science or whatever. More research needs to be done.

When you talk about public confidence in terms of the safety of these products, when we base the rules of the game in terms of what should go into these types of products, if they're based on science eventually they will gain public confidence, rather than people making claims as they go based on maybe one study or what have you. But there should be a set of good guidelines based on science.

Dr. Jennifer Armstrong: I forget what I was going to say, but it was good.

I think it is important for people to know they're getting products that are safe. It would be great for the universities to be able to do some more teaching in nutrition other than food. When I went to medical school 20 years ago I really remember them saying “We don't need vitamins.” That was the philosophy in those days.

It sounds like you're changing your approach, and that's very refreshing, because I didn't realize schools were changing their outlook. I'm getting many referrals now. A lot of the physicians you trained up to 20 years ago don't recognize some of these factors and their patients aren't recovering, because drugs aren't always the answer. If you have a headache, it's not a Darvon deficiency. If grants could help them start putting this in the educational program, that would be wonderful.

It's still an issue, though, if patients know they're getting good products. That's why I was wondering, if those of us who are using the products in the real world recognize that some aren't good, if there could be a way to report it and have them investigated or studied— That's the only way I can think of without it being too cumbersome.

The Chair: Just so you know, we have Mr. Volpe, Mr. Myers, Ms. Carroll, and Ms. Caplan, in that order. If you want to fight it out, you can fight it out amongst yourselves.

Mr. Volpe, you're first.

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Mr. Joseph Volpe: Thank you very much.

I gather from your evidence, doctors from the University of Toronto, that you really do favour the establishment of a third category for consideration. I'm glad. I'm so happy to again prove that my deductive ability is all shot.

Dr. Harvey Anderson: Mr. Volpe, let's make it perfectly clear; we don't favour a third category, because we don't think it's necessary. We think if you have a health claim category, as has been proposed in the policy document and that we've been talking about, then all substances with nutraceuticals, functional foods and, I suppose you could debate, botanicals and herbal components, whether they are nutraceuticals or what— The problem is definitions. I think the objective has to be the health claim. When it's in the dietary context, which can be beverage, food, perhaps the nutraceuticals, which are also defined as pill forms, if they can meet the standard of the claim, then they're regulated under that route, which is not a drug route, and I think we need to develop the scientific proof level that we will accept for a health claim. I do not think that should be at the same level at all as for a drug, where you're talking treatment of an individual because there's a problem and you're willing to trade off the risk and benefit.

By and large, I'm being very general, but I would say that when we're dealing with natural products, the risk component is certainly much lower than dealing with a drug and what you would accept. On the other hand, the benefit might not be quite as spectacular either, but when you're dealing with chronic disease and prevention and long-term effects, I think we can develop, based on epidemiology, the right laboratory science, if you will, the right experimental science criteria for making those health claims. So I think the issue is not a third category, but what is expected to be the result of consuming X, Y or Z.

Mr. Joseph Volpe: You have clearly done some thinking in that regard, but you haven't come up with a definition for, according to your brief here, an “appropriate standard” of scientific evidence.

Dr. Harvey Anderson: We have not, but we have offered to continue to participate with Health Canada in defining that standard, which is part of the purpose of this policy document. As a result of the consultation, as a result of the original draft that Dr. Jenkins was involved in putting together, we agreed that the next step was to try to move forward in this health claims category, but essential to that is to define the scientific criteria that would allow the health claims to be made. But I think we made a big step forward, and all the participants, of which many involved the people you have met with, in agreeing that the health claim was needed.

Mr. Joseph Volpe: Is it possible for you to come up with an appropriate standard of scientific evidence with respect to efficacy of products used in traditional Chinese medicines, or are we asking the wrong people?

Dr. Harvey Anderson: I'd say yes, it's quite possible. Would you put ginseng as a component of traditional Chinese medicine?

Mr. Joseph Volpe: But it's only one.

Dr. Harvey Anderson: I know it's only one, but there's an example of where ginseng growers of Ontario or Canada are supporting research to identify the beneficial physiological properties.

Mr. Joseph Volpe: I think that's an easy one to deal with. I was in conversation with some colleagues around a coffee mug a half an hour ago. I made reference to a Chinese-herbalist-store-cum-pharmacy. There must be literally thousands of products that have to be administered in combination in order to produce a claimed effect.

That's the example I'm thinking of. Were you thinking in those terms as well?

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Dr. Harvey Anderson: I'm going to let a real doctor answer in a minute. Again, I think the issue is that there are two levels. As professionals, as the physicians dealing with a patient and believing or having sufficient evidence that something works in combination, that's their choice in terms of management of an individual and treatment for an individual.

I am trying to address population health and health claims and I don't see a combination of Chinese medicines being applied to population health unless it goes through the “proof level”, if you will, of science that the ginseng producers are attempting to go through—and are doing.

Mr. Joseph Volpe: I'd also be interested in hearing Dr. Armstrong's response.

Go ahead, Dr. Jenkins.

Dr. David Jenkins: It's not possible to have the same standard for everything. Something may be a cholesterol-lowering agent, something else may modify glycemic effects or glucose effects, and something else may have laxative properties. They're all going to have particular criteria.

For example, criteria for laxative effects are the only ones Health Canada currently allows in this particular system. There's nothing to stop us from recruiting in other factors, but I think you have to be able to say, “If you want to make a claim, what are you making a claim about? What does this do?” Then we ask the scientific question: “What is the proof that it does it?” It will depend. Something may prevent ingrowing toenails, so the studies you need to show that it prevents ingrowing toenails are going to be very different from something that lowers cholesterol by 5% or 6%.

All I'm saying is yes, they will be subject to scientific proof. That is going to be your answer, if you like, if people want to make a claim. If people merely want to market something without any specific claim, then I can see no reason—providing the material is innocuous—why they shouldn't continue to do so and be good at it.

But if they wish to make a claim, it's in those areas, I think, that we have to give some support and encouragement; it's that area where companies will actually fill that bridge, that gap, between a good diet and a drug. It's a great void there. You must admit that we have nothing there; we have nothing with any particular guidelines for this vast area.

All we're saying now is that this vast area must be attacked. We must get into that area. We must start making sure that there are products between a good diet and drugs or drug therapy, products for which we can make regulations based on science and the appropriate risk of the product. These things are all going to be somewhat different. They're all going to require some extra thought.

Mr. Joseph Volpe: Dr. Armstrong, just before you answer, there's something you said in your presentation that caught my attention and that was—and I'll paraphrase what you said—that you actually test out some of the products before you prescribe them. Perhaps in your answer you might find a moment or two to give us an indication of how you do that.

Dr. Jennifer Armstrong: Okay. You want me to answer both questions.

First of all, I don't claim to be an expert on herbs, but I know some people who've used even the oriental herbs.

I agree that there is a vast number of herbs. I'm not sure if the oriental doctors who do acupuncture and use herbs think of medicine in the same way we do in traditional medicine, if they think of it as a cause and an effect, like this: if I do A, then B organ will get better. I think they think of their medicine in terms of an energy approach, that the meridians will fall into balance. It's just such a different way of looking at medicine. I don't really know—unless I sat down and talked to them more—how they could be put into a study at U of T in the same way that I was taught to do studies in medical school.

So that concerns me, and again, that's why I came up with the other suggestion. If there's any question on herbs and if there were somehow an organization made up of oriental physicians and U of T physicians and complementary medicine physicians...if somehow that registry or body could be reported to, maybe it could somehow help with certain herbs that people may be having problems with. I don't know. It's just a thought.

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When it comes to testing different supplements, yes, I do try them on myself. I can often tell how pure a product is because I was very sensitive at one time. I find there are very different types of vitamin C. Some vitamin Cs are much better than others.

When I first come to Ottawa I went to one of the pharmacists and asked him what his vitamin C was derived from and he didn't know. To him it wasn't important, but to our patients and the way we study medicine it is, because most vitamin C is derived from corn, and among people who are allergic to corn a lot of them won't tolerate the corn vitamin Cs; they have to have a corn-free one. Those little details of the vitamins are important, and I like to try them all before I recommend them to the patients.

The Chair: We'll go on to Mr. Myers now, please.

Mr. Lynn Myers: I want to go back to the appropriate standard of scientific evidence. I was very interested when you said that, and I was wondering what you envisioned there. Was it clinical trials or laboratory testing? What kinds of things? First of all, I wanted to get a sense of that. I think I now understand who and what and presumably how to proceed, but I did want to pursue the question of the traditional Chinese people and the aboriginal traditions of medicine. How would you argue against those who would say—and we've heard the evidence from them—that we have 5,000 years of evidence in terms of what we think could happen and should happen and does happen? How then do you say to them, “Wait a minute now, we think there should be scientific studies done and we should be involved somehow in doing the study”? How do you respond to people in that kind of situation?

Dr. Harvey Anderson: I don't think we can just guarantee public safety and public health based on historic beliefs and practices. Having said that, however, I think we should be taking a lead from that evidence and seeing what needs to be done to put it in a construct that does guarantee public health and benefits.

Again, you get reductionist by going back to ginseng, but I think that's an example of where that bridge is being built. How much money, how much time do you spend to build those bridges? I think, again, it's about the level of evidence. If you have some epidemiology that says in this population these benefits seem to accrue, it may well be that a group sitting down to look at this would say, yes, that is sufficient evidence, and it's sufficient evidence given the fact there's very low risk. It has a proven safety because of the tradition of use.

On the other hand, as you get more into some component of food or natural product that gets closer to where you're saying this might treat cancer, then I think you need to have a much higher level of scientific risk and clinical trial. So this is a gradient we're all talking about. I don't think it's incompatible with the—

Just to give you a sense, 20 years ago when I was probably teaching that course you're referring to, we didn't feel there was anything to environmental hypersensitivities and so on. But I chaired several committees and pushed forward on that for the province of Ontario. We put funding into it to try to start to understand better and help people who are practising in the area.

On the other hand, I was also a chair of the task force on amino acids for Canada. By putting them into a regulated domain, we prevented several deaths from Tryptophan in Canada. So it does get down to scientific judgment.

Mr. Lynn Myers: Has any of the scientific judgment, as you say, or the studies required been quantified? We hear people saying, wait a minute, you're going to put me out of business, you're going to put us out of business, you're going to take away our livelihood. You're saying no, we should in fact have scientific evidence and an appropriate standard and tests for safety and efficacy and presumably have good labelling and all the things you talked about. Has that been quantified? Can we go back to these people and say it really is x number of dollars, we think, based on average? Have you done any of that background?

Dr. Harvey Anderson: This is why I think it's important that we have a health claims category. Then you can start to answer those questions more specifically, because in some countries, just the epidemiological evidence is accepted and it wouldn't cost you a dime. Again, it depends on the claim you're going to make.

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So why would you wind up putting these people out of business if their problem is judged...? Now we're talking about the safety of its composition, and so on, and it's on the product, but I don't think you want to then all of a sudden say you can say on the label that this will cure cancer with no proof. There are other ways of building up a belief that something is beneficial, such as newspaper articles, etc., and if it's sold, they won't be out of business.

You're not asking that every single product, every single item out there, goes through and makes a health claim or else it just doesn't exist. I think Dr. Jenkins was referring to this as well. They're quite compatible.

Dr. David Jenkins: They may not want to make a specific health claim. They may merely wish to market their product and say that it generally improves health. They may say that in the Orient it's considered to do this, that, and the other thing. So this seems to be reasonable.

What we're really trying to do, though, is make an incentive for the people, for example, who Dr. Rao will be working with who are looking at tomato lycopene from Ontario, for example. This may prevent prostate cancer. Should we actually start to produce tomatoes that produce more lycopene? Should we have more ketchup that's higher in this red pigment, this lycopene, which may have these positive health benefits?

How we can get companies to go into this? That's the question we're asking. It's perhaps a different one from the one you're asking, but it's nevertheless one that I want you to understand is a real issue for us. How do we get companies to innovate and go into the field to produce things that are ultimately useful for the consumer?

The only way is to give them at least something that they can say, a health claim. That's where we're looking. So we're looking at it from a positive point of view, not from the negative point of view of trying to wipe other people out who have a business. It's to try to stimulate Canadian industry to go into this field.

They won't go into this field. I've been working for 20 years to try to get them in. I've got a few companies going, but it's very touch and go.

Mr. Lynn Myers: I think that's an interesting distinction. It's one worth noting. I'm pleased that we had that testimony.

Dr. Armstrong, I have just a very quick question.

I was really interested—this is on pages 2 and 3 of the questions you raised—in how government will monitor. That's number one. Number two is, how will government label?

I really want the word “will” to be “should” instead. I'm asking you, how should we do, for example, monitoring? How should we do labelling? How should we do this with respect to the nutraceuticals and such? Do you have any advice for us?

Dr. Jennifer Armstrong: As for the labelling, again, maybe as you were saying, maybe some products could have health claims, but not all products.

How would you label a multi-vitamin? We all have our own ideas on what multi-vitamins do. I think maybe, for some vitamins, it would be hard to give a specific claim, but rather label for sure anyway the constituents, or components, and additives, even little bits that could still be in the product due to the manufacturing process.

As to how to monitor it, I think that's an awesome task. I actually worked in the bureau of radiation and medical devices for a year. We came across that problem because there were so many medical devices being invented that it was not easy to keep up with them.

So I guess one of the ways to do this was to have them report it. I don't mind having to report the vitamins or whatever, but I'm concerned about the expense that it would incur on the vitamin companies. Although, if there's going to be the manpower to do it, then they have to be paid. So that's a concern.

From the vitamin companies I've dealt with, they want to produce good vitamins. They want to keep the business. So maybe if you could look at the approach that people want to stay in business, which they won't if they have a bad product, then hopefully, with a minimal amount of monitoring perhaps of some input to their manufacturing practices or some sort of minimal reporting system, that would be easier. Then if the public or the practitioners using the products have any concerns, maybe if they had some place they could report their concerns to that would minimize the number of regulations you would have to do.

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The Chair: Ms. Carroll.

Ms. Aileen Carroll: I, too, like my colleagues, have found this morning exceptionally insightful, and I'm delighted that you have come at the end of our discussion, so that issues have indeed begun to crystallize for us.

Speaking just for myself, at the outset I had little exposure to traditional Chinese medicine, or in fact to a great deal of what we've been looking at. My own academic background is such that I am very inclined to the scientific, and that in a western setting.

So for me, there was at the outset a conundrum, and there still is, even after listening to you today, for the reasons that I think Dr. Armstrong has highlighted. That is, it's very difficult to extrapolate from the system of Chinese medicine a group of herbs or a group of remedies and subject them to our system and have it be valid from their perspective, which is so very much a—I hate to use that overused word—holistic approach, again, from their point of departure. I still wrestle with that conundrum, in spite of the great insights you have shed this morning.

But you have come and are helping to contribute to the final process. I listened very carefully to your saying that you do not recommend a third category. I watched Dr. Jenkins' hands when he described what he has over here in food and what he has over here in drugs. There still is this area in between. Again, you don't want to call it a category. I hear you use the word category with “health claims category”. There's still a struggle.

Dr. Jenkins, I'm really excited to hear about your work. The impact, really, of industry here has been to highlight the threat to Canadian manufacturers that the unregulated, so to speak, or at this point American mail order companies are having. This is very exciting—to instead see what kind of growth is there for us to indeed become the industry itself and the manufacturing.

You say, how do we get companies to start producing when they are willing to do the research in conjunction with U of T, or on their own? Are we blocking them right now? Tell me, Dr. Jenkins, how, right now, we are blocking them, and how we can get rid of those blocks.

Dr. David Jenkins: Thank you very much. You've touched on a key area.

I think we are blocking them. I think it's what Dr. Anderson has been saying and what Dr. Rao has been saying. Probably Dr. Armstrong to some extent, too, would agree that what we need is to promote these areas.

We'll always have the conundrum with the things we can't measure—the different systems of medicine, the different problems—and maybe those are not things whose growth, as I said, we would want to in any way harm. What we do need to do, though, is to prevent the growth of the potential homegrown industries.

For example, we've worked with Yves on soy products—soy, which may have advantages for hormone-dependant cancers, breast and prostate, and may also, because of its protein, have cholesterol-lowering effects. Soy is an endogenous crop that could be very useful, could be a major export.

The problem that we have in getting these companies to develop more products along these lines—soy meat analogues and these sorts of things—even though they're very popular— I know at the school, when the children have parents days or what have you and we have barbecues, they order in soy, and the soy are always gone and there's the regular burger left. So these things are not unpopular, but they're not making the impact they could have. The developmental work is not going along because there's no hint of a claim. There's nothing that says this product may be healthy for cholesterol levels. In general, what we're saying is get rid of your burgers and weiners, or at least have them low-fat. So they're seen to be part of a general category of things that in general, from the health point of view, we're saying eat less of.

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These are analogues, if you like. They have many of the taste characteristics and certainly the appearance, that could be very useful, could be developed, and actually could end up lowering the serum lipid level. Can we say that this may have an effect in lowering serum cholesterol levels? That's the sort of claim we're asking about. Can we allow these things? They've been shown in studies to do so, but the claim is still not allowable.

I think it would be a product-specific thing. I don't know whether it would work where someone mixes something with saturated fat. I think it gets even worse when you get into the sorts of areas Dr. Armstrong is in, where there is a whole load of allergens of various sorts. But in our area, if a thing isn't produced properly, it certainly may not have the effect.

Again, one would like to see those particular companies that have made efforts to create products that are useful for us, to be able to say something in their advertisements, to say something as part of their strategy for marketing. If not, they're not going to go into the area.

The Chair: Dr. Rao.

Dr. Venket Rao: I just wanted to address the question that was raised in terms of Chinese herbal medication and how we can regulate that.

I was fortunate enough to participate in a recent forum—it was a couple of months ago in India, as a matter of fact—on an initiative that was sponsored by the Government of Canada in medicinal plants. We were sitting in a group with a lot of ayurvedic medicine practitioners, and we were on the other side. We started off by trying to talk about this very issue. We said it couldn't be done, that we couldn't be told how to test our products. But by the end of the day, we came up with a set of common features, if you will—they weren't like regulations—that we all agreed upon. Immaterial of which side of the table we sat on, we were all saying that the purity of a compound is important. The strength of documentation is important. Some types of studies that need to be done to document these things are important.

I'm saying that it's a big challenge, but to answer to what Mr. Myers also raised in the evidence the last time, I think it can be done. I think these guidelines can be developed, but the challenge is there.

The Chair: Do you have a report from that trip?

Ms. Aileen Carroll: Can you send it?

Dr. Venket Rao: It is coming. The report will be published, and as soon as I get a copy of it, I shall make it available to you, Madam Chair.

The Chair: Yes, especially your conclusions. If you could send it to the clerk as soon as possible—

Dr. Venket Rao: Sure.

The Chair: Mr. Boychuk, we've reached our time limit, so we're going to have to—

Mr. Andrew Boychuk: It's just a brief one for Dr. Anderson here.

You mentioned about Tryptophan being dangerous. I have it on the word of a very prominent American research doctor in the field of amino acids—

The Chair: May I ask that you talk to the chair and not across this way.

Mr. Andrew Boychuk: —and he claims that the only deaths that resulted came from one defective batch that had been imported from China. That's all. I think that would hardly qualify as a reason for banning a very good supplement.

The Chair: Yes, you've said that a number of times.

It's up to the committee as to whether or not Ms. Wasylycia-Leis is allowed ask you her question. It's twelve o'clock. Can she ask her question?

Ms. Elinor Caplan: She can ask it, but we're not going to stick around.

Some hon. members: Oh, oh!

The Chair: Ms. Wasylycia-Leis.

Ms. Judy Wasylycia-Leis: I apologize for missing your presentations, but I've skimmed through the papers and I want to raise very quickly an issue that I'm fairly confident hasn't been raised yet. It has to do with the capacity, both within government and in partnership with government, for in fact doing what your papers describe. That would be to ensure safety, efficacy, and quality around all of these products, and to promote the nutritional value of certain products.

We are dealing right now with a situation whereby the bureau of drug research has been cut, although there is a moratorium on cuts to the food research bureau. Based on your papers, it would seem to me that it would be necessary to ensure effective and competent staff within government around drugs, foods, and natural health products, both in terms of the safety and efficacy issues and in terms of the need to promote alternative health options in our society today.

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What is your position on the current situation in the Health Protection Branch? It has serious implications for what we do as a committee in terms of health products. Many have said we need a capacity to follow through on this kind of guidance and direction.

Dr. Harvey Anderson: The point you have to recognize is that we have limited scientific talent throughout the country. I could comment on the situation within the government, but it seems to me we can work in partnership. Other countries manage to use advisory bodies effectively in making decisions so they get through the process quickly and in a timely way and so they make good judgments.

We have to work together in Canada. You can't expect to build up just within government, the University of Toronto, UBC, or whatever the total expertise that's needed. We have to have mechanisms for what Dr. Armstrong mentioned: to embrace practitioners and have them be part of the decision-making process. Other countries have been able to do it. It doesn't all have to be in-house.

Ms. Judy Wasylycia-Leis:

[Inaudible—Editor]

Dr. David Jenkins: To an extent we're doing that already. We have expert panels and expert committees. These are volunteers drawn from university groups and general groups. We're already contributing.

As Dr. Anderson said, if we can continue this process, then you may be able to find the resources. I don't think you'll be able to cut back the resources, but it may be possible to levy some sort of reasonable fee, too, so there can be some cost-recovery for some of these activities.

The Chair: Thank you very much, Dr. Jenkins.

Ms. Aileen Carroll: I just want to say something very quickly. I usually am a very quiet little member here, but on occasion I get very excited, and this morning has been exciting.

I would hope that last point would not be missed in our notes and in all of our minds, as our numbers have depleted and it is the end of the day. The partnerships that already exist have every opportunity to succeed. The rebuilding of in-house is not necessarily the route.

There's nothing like my daring to add a footnote to learned doctors, but I love to do it.

The Chair: Thank you very much for appearing in front of us.

The meeting is adjourned to the call of the chair.