HEAL Committee Meeting

STANDING COMMITTEE ON HEALTH

COMITÉ PERMANENT DE LA SANTÉ

EVIDENCE

[Recorded by Electronic Apparatus]

Tuesday, February 3, 1998

• 0916

[English]

The Chair (Ms. Beth Phinney (Hamilton Mountain, Lib.): I call to order the twelfth meeting of the Standing Committee on Health. I welcome back all the committee members after our recess to work in our ridings.

This is pursuant to Standing Order 108(2), a consideration of natural health products. We welcome as our first witnesses the Advisory Panel on Natural Health Products. The chairman is Dr. Frank Chandler.

Good morning. We ask you to introduce the three guests with you.

Dr. Frank Chandler (Chair, Advisory Panel on Natural Health Products): Good morning, and thank you.

I have a few introductory comments before we start on our actual presentation. We have four of us from the panel here this morning. We've been nominated by our colleagues to represent their interests and present our interim report to you this morning.

I'm Dr. Frank Chandler, director of the College of Pharmacy at Dalhousie University. I have about 35 years of experience with plant-based medicines and about 20 years of experience with herbal remedies themselves.

Joining me today are Mary Wu, doctor of Chinese medicine, director of the Toronto School of Traditional Chinese Medicine and a practitioner of traditional Chinese medicine; André Gagnon, president of Santé Naturelle—André has significant experience in the manufacturing and distribution industry for natural health products—and Dr. William LaValley, a medical doctor, a practitioner of complementary medicine, and founding president of the Canadian Complementary Medical Association.

We thank you for the opportunity to address you this morning.

In the beginning, in May 1997, our panel was struck by the then Minister of Health Dr. David Dingwall. We were then called the Advisory Panel on Herbal Remedies. At that time we were charged to report to the therapeutic products programme.

After the election in October 1997, the new Minister of Health, the Honourable Allan Rock, reaffirmed our panel and shortly thereafter broadened our mandate and renamed us the Advisory Panel on Natural Health Products. We were then directed to make our report to this committee.

In both instances our mandate has been to advise on the application of current regulations and policies being applied to natural health products. Some of the outcomes from our advice have taken place and have been promulgated through various avenues. The mandate we have been spending the majority of our time on is to develop a revised regulatory framework that better reflects the needs of consumers and industry in natural health products.

I think it's important to emphasize that our panel is a broad cross-section of stakeholders in the field of natural health products. We came from a variety of cultures and experiences and a variety of expertise. We came from across Canada. I think it's safe to say we all came with a passion. But most importantly, we came together with a vision of improving the system and a willingness to work towards a common goal. Even though we came with varied backgrounds and varied opinions, especially on how to reach our vision, we have worked collectively to identify issues and advise on current practices and we have developed a draft regulatory framework.

My colleagues on the panel have been dedicated to its mandate. In my opinion they deserve serious congratulations on achieving so much in such a short period. The panel is also indebted to the many members of TPP who have worked hard and long hours to educate us in the regulatory issues and in assisting us with the many needs of our panel.

• 0920

The panel has met only four times. We've had an electronic conference and we've had two or three conference calls. While I think we've accomplished much in that short period of time, I don't want to leave you with the impression that the work is all done. We still have much to do. We have identified a number of issues that the panel itself has yet to address, and we hope to do these in the weeks immediately ahead of us.

It is important to recognize also that our interim report attempts to address primarily the regulatory framework, the large picture. Although our panel is very concerned about how this will be implemented and who will implement it and who will oversee it in the future, we see these largely as topics for future discussion once a regulatory framework has been accepted.

One of the first things we had to do was define what we believed was meant by “natural health products”. Slide 3 has our definition. It's a relatively scientific one, but we have also elaborated upon that, with much more elaboration on page 15 of our report, with examples of what we believe is inside our mandate. It is this broad range of substances for which we have developed the draft regulatory framework.

In addition to the definition of “natural health products”, the panel quickly found consensus upon a number of fundamental issues we needed to address. We framed these as our guiding principles. They're outlined on slides 4 and 5.

The first guiding principle is the expression of the problem as it currently exists and the driving force for all of our action.

The Food and Drugs Act as it currently exists has only two categories, foods and drugs. These are clearly defined, and all substances at the moment must therefore be defined or regulated as either a food or a drug.

In the early fifties, when the current act was promulgated, these two categories were clearly identifiable by both the consumer and the industry. By the late sixties, herbal remedies began to appear on the market in Canada. By and large, these products were and still are being regulated as food, even though the consumer is using them as a drug or a natural health product.

Since you cannot make medical claims for food, these products were on the market without instructional label information. There was no clear indication for their use, no clear dosage, no indication of precautions or contraindications. Clearly, the consumer's safety was not being adequately addressed by the regulations for these particular products.

To adequately address this issue we believe that natural health products need to be formally defined. We believe that a separate regulatory structure with appropriate natural health products expertise is required. We believe that a regulatory framework is required to ensure quality and safety of all products. We believe that sufficient valid information must be made available so consumers can make informed decisions about the use of natural health products.

We also recognize the need for a system that incorporates the many culturally and philosophically based complementary medicine models and that the system should encourage their integration with conventional medicine. We recognize the need for an effective and cost-efficient system of regulatory compliance. We also recognize the need that this system not place inappropriate cost or other burdens on the industry. We recognize the need for the consumer to have freedom of choice and access to high-quality, safe products. We recognize the need for fair and equitable treatment of all competitors. We recognize the need for an open and transparent appeals process regarding product and establishment licensing processes.

Slide 6 identifies some of the items we consider to be major issues.

First, the Food and Drugs Act, as I've already mentioned, does not provide enabling legislation relative to the natural health products. Second, the act is outdated and needs to reflect the concepts of health promotion and health maintenance.

• 0925

Schedule A in the act is outdated, and the legitimate use of natural health products, and even drugs, by practitioners and consumers is illogically limited. Schedule A is a problem because it lists a number of diseases, disorders or abnormal physical states for which treatments, preventatives or cures cannot be advertised or sold to the general public—things like garlic to treat hyper-lipidemia—and are not legally on the market unless they go through the drug process.

There is no comprehensive regulatory framework to appropriately manage natural health products, and in our minds there is not sufficient expertise either in breadth or depth within the therapeutic products programme to adequately address natural health products.

Following the identification of the issues, we see as steps to the solution the need to develop a separate regulatory structure that would have decision-making power for the development of regulations, policies and guidelines for natural health products. We see the need to staff this structure with individuals with expertise, experience and understanding of natural health products, and we see these individuals as being separate from those evaluating pharmaceuticals.

We see a need to repeal schedule A and a need to develop a marketing process based on notification where monographs or standards exist, and on a modified submission process where they do not. For the purposes of our deliberations as a panel, we have defined loosely a monograph or a standard as a document that describes the source, the characteristics, the biological activities, toxicities, precautions, dosage and contraindications and so on of a given plant or product. If those monographs are established, you will then be able to license a product through a notification process.

Apart from the guiding principles, some of the so-called cornerstones of our regulatory framework are outlined on the next couple of slides. When developing our regulatory framework we agreed to use a risk management approach. Such an approach requires the assessment of the relative risk of a product, the nature of the claims made and the dosage form. The seriousness of the disease for which claims are made and the evidence of effectiveness of the products must also be considered. Regulatory controls increase with increasing risk.

When developing our framework, we considered the relationship of all health products, from conventional foods to pharmaceuticals. As previously mentioned, three elements are the primary consideration when classifying foods, natural health products or pharmaceuticals:

First, the health claims. Are the claims for structure-function relationships, are they for risk reduction, or are they for treatment?

Second, what is a dosage form? What is its intended route of administration?

Third, what is the level of risk of the product? Is it low, medium or high?

In our report we've made attempts to define those in more detail.

Some of the most fun the panel has had so far is trying to create figure 1, to represent the words that I've been presenting to you and are found in our text. What we have presented here this morning attempts to reduce our comments to a graphic illustration. Not only does it provide a graphic view of the framework, but I think it also very graphically demonstrates the complexities of the issues facing the panel, and now the standing committee.

In this presentation we've endeavoured to demonstrate three distinct categories. They are conventional foods, natural health products and pharmaceuticals. It is our intent that conventional foods would have no allowable claims, that functional foods would have claims, and that all products presented in a dosage form have the option of appearing in all four of those categories. Within each category you can see that we have defined high, medium and low risk aspects.

• 0930

Much has been accomplished and consensus has been reached on a number of issues. However, there are issues that require more discussion in order for a resolution to be achieved by the panel. These include discussions on three significant issues that are identified, but the panel has had little time to discuss them. These are presented on slide 11. We've identified the need for a separate regulatory structure, but we have not yet adequately addressed the nature of this structure and its total function.

We've agreed on a notification process, but again we have not agreed on whether it is pre-market or post-market and how to manage this actual process. Again, we've just not had enough time to adequately address it. We have agreed on the idea or concept of establishment and product licensing and probably associated fees, but we have not agreed upon the nature of how these would be applied, the pros and cons for each one, and who pays and how much, and some of the details that go with that. We clearly have much work to do ourselves.

Over the next few weeks the panel plans to continue its work toward arriving at a consensus on outstanding issues. We intend to monitor the presentations to the standing committee. We will finalize our report on regulatory framework and we hope to do this in the same sort of time the standing committee has set for it as well.

When all is said and done, we must have a system that is fair and equitable to the industry and provides the consumer with a high-quality, safe product in an environment that permits easy access to a broad range of products and to appropriate information to permit informed decisions by the consumer.

As we do represent a broad cross-section of stakeholders, Madam Chair, we respectfully request an opportunity to present our final report to the standing committee.

Thank you.

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

Dr. Hill, do you have something for the panel?

Mr. Grant Hill (Macleod, Ref.): Thank you.

I appreciate your being here and I have one immediate question that comes to mind. As a standing committee we are doing work that sounds very parallel to yours. In fact, it might be repetitive. Can you help us so that we don't redo work that you've done, hear people you have listened to, and so on? We'd hate to be redundant.

Dr. Frank Chandler: When we were initially struck by Minister Dingwall, one of our responsibilities was to hear a broad range of stakeholders. When the standing committee was struck, we saw that as somewhat redundant. So we have relied on our own resources within the panel, if you like, even though that's quite broad-based. So you will be hearing from people that we have not heard from, and in that regard it will not be a redundancy.

I believe I'm safe in saying that it is the hope of our panel that you will see what we've presented today as a sort of first step in this process and maybe use it to frame a lot of your questions and discussions with the groups that come forward, to see if there is indeed consensus on the larger ideas that we have presented here.

Mr. Grant Hill: You use pretty strong words when you say that schedule A is outdated and that the health protection branch has insufficient expertise to deal with this issue. Those are not usually words that I hear used in a bureaucratic sense. How do I balance that with what the health protection branch told us not so long ago, that things were pretty good, that there were not huge changes required, that they were well apprised and well abreast of this issue?

Dr. Frank Chandler: There have been many changes within the health protection branch in the last several years. I think they're moving in the right direction and I think there is an openness now to try to more aggressively meet the industry, but I think it is still the opinion of our panel that they do need more expertise in that area to adequately address the needs of the industry at large within this concept.

André, do you want to add?

• 0935

Mr. André Gagnon (Advisory Panel on Natural Health Products): There were two parts to your comments. One question was on schedule A. I think most people even in the TPP recognize that schedule A has to be, if not repealed, then readdressed. In fact, a paper has been issued by a TPP employee giving arguments about the fact that schedule A should be revoked. So this is one problem where there might be not as much dissent as with the other one, talking about expertise.

About expertise, it's one thing to be an expert in pharmacy or toxicology, but things are going so fast with these products that even to follow what is going out in the U.S. and Europe on a daily basis would be a full-time job. It's not just a matter of being able to evaluate who has the intellectual power to analyse it. It's a matter of being involved in those products, in that field. That makes the difference between expertise and qualifying someone as having expertise or not. It's not a judgment based on the person. It's really based on expertise on these particular products. So yes, this is lacking right now.

Dr. Mary X. Wu (Advisory Panel on Natural Health Products): About lack of expertise in regulating natural health products, I think TPP staff do have the expertise in regulation as well as in regulating pharmaceutical products, because they have been doing this for so long. I admire their expertise in that aspect.

In regulating natural health products, somehow it is inadequate. They have been learning to do it, but in order to regulate natural health products properly they need more expertise, and adequate expertise, in the organization in understanding how natural health products work and the philosophical and cultural background behind it. For example, for traditional Chinese medicine I know a couple of staff themselves are Chinese, but when it comes to knowledge of traditional Chinese medicine they do not understand enough to establish a policy to regulate these products properly.

The Chair: Madam Picard.

[Translation]

Ms. Pauline Picard (Drummond, BQ): Mr. Hill asked the question I was planning to ask. If you do not have the authority at the moment to approve products, how will you be able to establish a framework in keeping with your mandate? How will you be able to establish a regulatory framework respecting peoples' freedom of choice, if you do not have the authority to study products, as is done in the case of drugs? What are your objectives? How can you improve the expertise of individuals who study natural products?

Mr. André Gagnon: That is the fundamental question. It should be noted that the regulatory framework could be devised to include all these aspects. The definition is very important, as is Schedule A. There are a number of aspects which, once they are established, must subsequently be incorporated into a structure. The most important issue, at least in my view, is that structure. Regardless of the definitions, regardless of the other aspects, ultimately, someone will have to make a decision about whether or not a substance can be sold in Canada, given that it is sold in the United States, for example.

So our objective is to have individuals who, based on the practice throughout the world, will be able to determine the value of an advertisement, its truthfulness, and the safety of a particular product. Many things are based on this point, and it is not easy to determine the composition of the structure in question.

• 0940

For example, will the TPP retain the authority to employ these individuals? Will they be TPP employees or will they be from the industry? Will we have some type of committee that will work with the TPP and the industry? None of this is clear. One thing is certain: the decision-making authority must be satisfactory to the parties involved. To date, this authority lay almost always with the TPP, and this was not satisfactory to the industry and did not reflect the real situation. In my opinion, the greatest challenge is to devise a structure that all the parties involved will find satisfactory.

Ms. Pauline Picard: What are the advantages and disadvantages of the current regulatory framework in your view?

Mr. André Gagnon: It has more disadvantages than advantages. The most significant disadvantage is that it prevents the sale in Canada of products that are not harmful to human health, that are in fact useful. We are always four or five years behind the United States or Europe. That is a very important point. In any case, we now get all the information in Canada through the media. Canadians get all this information either through the Internet, magazines, newspapers or television. Canadians are informed and they will always have to make enlightened decisions based on their personal judgment.

So that is the most significant disadvantage. We are unable to sell certain products in Canada that are not dangerous. There are two reasons why we cannot say for these products might be used to treat. First, there is Schedule A, which does not exist in the United States. The schedule includes so many diseases and consequences of diseases or secondary problems related to these diseases, that the result is to limit the use of products that could be useful. That is a major problem. I would say that these are the two main disadvantages.

Under the heading of advantages, we could say that Canadians are overprotected by this Canadian-style system. We could adopt that view. Canadians are extremely protected, so much so that rather than take any risk whatsoever, they are denied products that could be helpful to them. That is the advantage of the system.

The US system is completely different and is based on free enterprise. The American system is really based on self-censorship by the industry. This is a completely different model.

In Canada, we are at the extreme opposite end of the spectrum. Our system overprotects citizens. Can we find a happy medium? I hope so.

Ms. Pauline Picard: Thank you.

[English]

The Chair: Madam Caplan.

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

The model you've proposed I find very interesting. How much involvement do you feel we need to have on those products that are low-risk, and where they don't make any claims?

Dr. Frank Chandler: I think it's safe to say that the panel sees those as products that could come to market quite quickly. This is where the notification process comes in. We develop standards. A lot of those products exist elsewhere in the world, so we'd have to do our Canadian stamp on them. But there are some good standards elsewhere in the world that we could accept fairly quickly, and then with those accepted by industry and government notification that you're living up to those standards, your product would be on the market.

As my colleague has said, the current situation does not serve the consumer well in that it is an industry-driven process to market them as drugs, whereby you get the information on the label that a patient needs to make an intelligent choice on how to use these. If they elect to go through the food process, then the consumer has to rely on their own wits to get a product that might work.

Ms. Elinor Caplan: Have you looked at the situation where it depends on where a product is sold as to what regime it's under? I've had representation that says that consumers who go into a drug store are in a different situation from those who go into a natural health products store or a herbalist.

Dr. Frank Chandler: We have talked about it briefly, but it's not been a major point of our discussions at this point. We have been more concerned with the quality and safety of the product. We do make one recommendation in our report that suggests we do need to regulate the practitioners. That's as far as we've gone. Who that practitioner might be, the qualifications, we have not dealt with at all yet.

Ms. Elinor Caplan: Could you expand a little bit as to what your thoughts are on regulation of practitioners?

• 0945

Dr. Frank Chandler: Well, most people who deal with our health have some self-regulation or are legislated through acts and other pieces of legislation to make sure the practitioner is qualified to provide the advice the patient is receiving.

In natural health products we have a range, from very highly qualified people to those, unfortunately, who are less so, much less so, possibly placing the consumer at some risk.

Ms. Elinor Caplan: My last question has to do with the expectation of consumers. I support the idea of people having freedom of choice and the ability to make informed decisions. Having said that, the expectation of Canadians, whether they are buying food products or what we have traditionally thought of as drug products, whether they are natural health products or the traditional pharmaceutical products, is that they are safe and that the product is of good quality. Then the question becomes how and what the role of the regulators should be on the issue of effectiveness, whether or not the individual should be able to have access to a product that is going to help them, or if they feel they want to give it a try. I wonder whether you've thought about that.

We all agree on safety and quality of the product. The issue of claims and false advertising and all of that is often dealt with under other regimes. I guess those people who want the right to give something a try are the ones we've been hearing from. I wonder if you've thought about that.

Dr. Frank Chandler: We have. We've discussed it at some length in the panel. As our report reflects, we are primarily concerned with the quality of the products, so if you go out to buy product X, that's what you actually get.

Our secondary concern, and also a very high-level concern, is that of safety. We want to be able to assure the consumer that based on the available information, the product they're buying is safe. That's why we'd like to see some labelling controls. For some populations—pregnant women, people with high blood pressure, or whatever—some individual herbs may not be good choices. We'd like to see that information on the label.

The effectiveness or efficacy aspect is where we've had some disagreement, but I would say in the majority opinion at the moment, probably we're leaning towards letting the marketplace decide on this one.

Ms. Elinor Caplan: That's what we heard from the health protection branch. They believe they have a role in that.

Dr. Frank Chandler: Yes.

Ms. Elinor Caplan: Is that where the problem is right now, their entrée into the field of efficacy and effectiveness?

Mr. André Gagnon: This is a core issue, of course.

For one thing, depending on the claims you are making, it might vary. If you're just making a nutritional support claim, that's not complicated to understand. Even with those types of claims, we're not able to do some of these with existing regulations. So at least we need to open up nutritional claims. The same for structure function claims. Those are not a higher degree. For example, calcium supports bone development. That's not a big deal. It's only a support claim. People understand what that means.

The question we're asking might be more when you reach treatment claims, where it might become more critical, but a lot of products we sell in natural health products are aimed at nutritional support structure function or risk reduction. It might be true arriving at treatment that you may need more additional information or data supporting the claim you're making, but on a lot of products, the consumer could decide if the product has efficacy or not. It seems simplistic, but the consumer won't keep on using a product if he's not satisfied with it.

Then you have the argument that if he takes it and it's a not a good product, he's at risk, because he could have used another product. I hear that often. I think Will can comment on this or maybe expand on others.

Dr. J. William LaValley (Founding President, Canadian Complementary Medical Association): Clearly safety is a primary issue. We want the products to be safe when they're over the counter or behind the counter, even those inappropriate indicated uses that would be considered prescription or like prescription.

I'd like to address two of the points you brought up. One is the efficacy issue, the evidence, and then how that folds into the issue of expertise within the regulatory structure.

• 0950

Clearly, what's required is decision-making authority within a separate regulatory structure where those who have that expertise are familiar with the field as it's actually practised, whether it's practised by the consumer or by various health care providers, conventional or complementary. This brings up a conundrum with regard to regulation of those providers, because across the country that's a provincial issue and clearly for the vast majority in the country they're not recognized.

So the recommendation here, the difference between what we're calling medium risk and high risk, is based on the assessment of the safety of the product that would then require a practitioner to have intervention, to be provided through a practitioner rather than just over the counter without any regard for a practitioner's expertise or consideration.

When we talk about the evidence base, the conventional approach to looking at the way pharmaceutical drugs are assessed is very different from the way natural health products are assessed, or, what we're saying, ought to be assessed, because of the specific nature of these. They generally pose far lower risk, which means a much higher safety margin.

We're defining “risk” not just as safety, but as the factors of safety, how it's dosed, what the seriousness of the disease is and the claim involved.

So the issue of claims with safety, when we're talking about evidence, is who is going to make that assessment? Those assessments have been made by people who don't have the expertise in the field, don't understand how it's actually practised, and so they're setting them to a criterion or a rigour that, because of the lack of research funds available.... Because generally these are not patentable molecules or combinations of patentable molecules, there are not the research funds available that would support that level of research.

So we have to fall back on what exists, and that is essentially traditional references, which are very widespread.

Other published literature: Certainly in the United States there's a large database that's growing. The Office of Alternative Medicine at the National Institutes of Health has amassed a very large database.

We can also look at clinical evidence, which is including, but not limited to, controlled trials. So it puts it on a par with surgery, cancer therapy and pediatric therapeutics, where we don't have very good clinically controlled trials and yet we're still practising and spending vast amounts of money and resources in this.

The last is that I think it's important to know what the professional consensus is so that unreasonable claims aren't made. There could be room for abuse here, and unless there's some sort of expertise within the field, within the regulatory authority, that can ascertain what is reasonable, then we're back to square one.

The Chair: Thank you.

I'm allowing a little bit of leeway with the answers, but please keep your answers short, because everybody has their turn and the time is away over on one of them.

Ms. Wasylycia-Leis.

Ms. Judy Wasylycia-Leis (Winnipeg North Centre, NDP): I'd like to thank the presenters for their excellent overview of this issue and for clearly in-depth work on an area that we're grappling with.

However, it does beg the question that I'm not sure the panellists can answer, but perhaps the parliamentary secretary or someone from the government can answer, and that is, why are we here?

Mr. Joseph Volpe (Eglinton—Lawrence, Lib.): Do you want to ask the question or do you want the answer before you ask it?

Ms. Judy Wasylycia-Leis: No, I want to ask the questions.

It really does beg the question of why we are here and what we are doing as a committee, because the panel, which is a government-appointed panel to develop a framework for regulatory mechanisms in this whole area of natural health products, has exactly the mandate set out for us in the letter from the Minister of Health dated November 13, when he suggested that we consult, analyse and make recommendations regarding the legislative and regulatory regime governing...blah, blah, blah.

It would be stupid for us as a committee to be duplicating work that is going on and trying to come up with a regulatory framework if the work is being done anyway and if the minister is going to be paying careful attention to the results of that panel's work.

• 0955

So my question is, would it not make more sense, if this recommended regulatory framework, although it doesn't have all the details fleshed out, is the direction in which the government is headed and if the Minister of Health is looking at it seriously, to as a committee take this as the basis for our discussions with all of these individuals and organizations we're going to hear from over the next two months and to get comments on it?

I don't want to spend my time reinventing the wheel, duplicating, if the work is being done and if we're going to end up with something along these lines anyway. It would be far more helpful if we could get input and fine-tune this to make this better, if that's the case.

We also know the Reform Party and the health critic are off doing their own proposals around this issue with a proposed bill regarding a “foods are not drugs” amendment. So there's also work being done in that regard.

The other question is, with all the international agreements that are happening, and the gap in international standards around natural health products, probably there is work going on at that level. I don't want us to be duplicating that work, or doing work that will then be superseded by some development on the international scene.

The Chair: Would you like an answer from Mr. Volpe or from Dr. Chandler?

Ms. Judy Wasylycia-Leis: I'd first like to hear from Dr. Chandler in terms of the status of this report.

Mr. Joseph Volpe: I have a point of order, if you don't mind. I know Dr. Chandler is dying to answer a question that's political in nature, but I have to take a moment here, because I've been called away.

It's really surprising that an NDP critic would have the same position as the Reform critic. Both of them have blurred the concept of a parliamentary democratic process.

I have to take the first part of the question as an admission that the minister and the department have done the appropriate thing, which is to engage the expertise available in the field in the deliberations of both the department and the minister himself. So I thank the member for doing that.

The second part of the question is that maybe, just maybe, the member has confused “expertise” with “public input”. It is the responsibility of this committee to engage as much of the public as is possible in the consideration of a politically formed perception on this deal. If the member, like her Reform counterparts, is anxious only to have the expertise that's available in the formulation of a decision, well, then, I guess we can go ahead and lock up Parliament and let the experts decide everything.

This is part and parcel of the political process. We hope Dr. Chandler and the others will provide input not only to the minister but also to the parliamentary process, through this committee, so that together we might be able to arrive at a decision that will serve the interests of the Canadian public.

I know Dr. Chandler wanted to say that, but I couldn't resist the bait.

Ms. Judy Wasylycia-Leis: On a point of order, just on the point of order, I think the parliamentary secretary misrepresents my position. We have clearly supported consultations as far and wide as possible on this important policy area. My point is that it would be a disservice to the principle of democracy and an unfair position for all of these people we're consulting if in fact there is a rough framework that has been outlined and may in fact be the course of action or direction for the government.

I'm simply trying to seek clarification on the status of this report to know whether or not we should then go to all of the people we're consulting with and ask what they think of this. Let's not start from scratch if this is the predisposition of the government. I think that's a fair question.

Mr. Joseph Volpe: I'm not prejudging what would happen, but I'm sure Dr. Chandler and his group would also welcome the opportunity to reach the general public through the representatives of the public. That's one of the functions of a committee.

Ms. Judy Wasylycia-Leis: I'm quite happy with that.

Mr. Joseph Volpe: We're not prejudging anything, and I hope you won't either.

The Chair: Thank you, Mr. Volpe.

Dr. Chandler, do you want to add anything?

• 1000

Dr. Frank Chandler: I think my answer has been given, and very well, thank you. But as I mentioned earlier, our initial mandate was to use our internal expertise to draft a regulatory framework and then to go to the stakeholders across the country to get feedback on it. That process got changed with the change of ministers. We still are there to try to develop this expertise and bring it to you, but the consultation with the stakeholders still needs to take place.

We are only 19 people, although we come from very broad backgrounds, including consumers and native population and so on down the line. I would be delighted, and I think the panel would be as well, if you took our regulatory framework as an initial step and discussed it with others as you are meeting with them, to see if it works, what needs to be refined, what doesn't. If we could get that feedback on an ongoing basis it would help us in our deliberations as well.

The Chair: Thank you, Dr. Chandler. Would the advisory panel make copies of its interim report available to the committee?

Dr. Frank Chandler: I thought they were. This is a 16- or 17-page report.

The Chair: No, we don't have the interim report. Could you make it available?

Dr. Frank Chandler: We certainly will.

The Chair: If you send it to the clerk we'll all get a copy.

Dr. Frank Chandler: My apologies. I thought it was available.

The Chair: Mr. Myers.

Mr. Lynn Myers (Waterloo—Wellington, Lib.): Thank you, Madam Chair.

I wonder if I could ask the advisory panel whether or not they had heard directly from international regulatory agencies on what they are looking at and if they could share any of that information.

Dr. Frank Chandler: We have not heard directly, but we have seen documents from several other countries on their position and their movements towards regulating this process. It's my understanding that the therapeutic products programme, or directorate, are working on the international level to develop memorandums of understanding or agreement, or whatever they are called, to recognize some of the standards elsewhere in the world.

Mr. Lynn Myers: Can we see that once that's formulated or developed or when you have it in some form that can be shared?

Dr. Frank Chandler: It's referred to very briefly in our report. We've created the Canadian thing knowing what is going on elsewhere. But some of those background documents likely could be made available.

Mr. Lynn Myers: I wonder if you know, in what you've been doing by way of study, the size of the sales and use of natural health products. Do you have a handle on the extent to which they are being used, and is it broken down into categories?

Dr. Frank Chandler: The levels are very significant. It's one of the most rapidly increasing categories by sales, by dollars and volume, of any health aid in the country—in fact, across the western world—at the moment.

Mr. André Gagnon: Right now natural health products are not identified by Statistics Canada when it collects real numbers. Most numbers come from industry; from different associations where you can gather this information. Unless I'm wrong, it's not officially in Statistics Canada. You might have vitamin and mineral supplements in there, but those cover only a small part of what we're talking about.

I want to emphasize something about the first part of your question, on international regulation. I would say to spend real time on that issue would require a lot of time, because it has to be looked at. I feel we should put more into looking at what is going on elsewhere. We don't necessarily have the time or resources to do that. I think we still need to look a little more at what is going on elsewhere, instead of just saying, well, there are some problems with the U.S. model. We hear that often. You will hear that: the U.S. system has many problems. Still, they are selling products, they are doing business, and there are not many cases of damage in the population. I think we discarded it too fast. We're not putting enough time into that.

Mr. Lynn Myers: That would be my view too, for what it's worth.

I want to go back to the question of risk assessment and management. Would you agree that different levels of evidence are needed, depending on the categories, vitamins and minerals, homeopathic medicines, herbal and such? If so, how do you sort that out? How does that get worked out?

Dr. Frank Chandler: I agree there is a different level. That's one of the issues we still need to do a lot more work on: what is acceptable at each level. I think you need the general picture first, that yes, we agree you will need different levels of expertise and evidence for different categories, different levels of risk. But what that would be....

I came from the pharmaceutical side, and it took us 12 years to do that with the drug schedule. I'm hoping we've learned a lot there and we can move this much more quickly.

• 1005

Dr. William LaValley: In general, especially when we look at much larger populations, whether in Europe or in the United States, the high usage of these products for sustained periods with long historical records shows that very largely they have a high safety margin and also a low risk.

The issue I think we're looking at is that there are a lot of questions about the safety and the lack of evidence about efficacy and there's often a lot of confusion between the two.

Safety is an issue different from efficacy, and when you look at the statistics in pharmaceuticals.... I want to be very clear and on the record that I strongly advocate and use prescription drugs, or pharmaceutical drugs, for my patients and think that they have a very necessary requirement within the health care system. When you look at the data published in the Journal of the American Medical Association, you see that annually 100,000 people in the United States die from the use of pharmaceuticals. This is the indicated use. That would be considered acceptable risk.

When you look at where the data about this in natural health products are, the data are sparse or non-existent. So we're looking at a wholly different category, which is why we need to recognize that unique nature. We have to have some recognition as to where the high risks are.

The high risks come when we're requiring the intervention of a practitioner. That, again, gets to what I was talking about before. We have to recognize these practitioners across the country with the appropriate accountability and the appropriate recognition so that we guarantee safety to the population.

I hope that answered the question.

Mr. Lynn Myers: Yes, that's very good. Thank you very much.

The Chair: Dr. Chandler, I don't know whether this was clear when a previous question was asked. Could you tell us to whom you are accountable? Whom does your report go to? We know, as politicians, to whom we're accountable. Could you tell us to whom you're accountable at the end of the report?

Dr. Frank Chandler: I'm not sure I have that 100% clear, but my understanding is that we're to bring our report to you. We're also working hand in hand with TPP, so they will be receiving a copy of our report as well. In the last letter, my understanding is that we're accountable to the standing committee.

The Chair: Thank you.

Dr.—Mr. Elley. I've got everybody as a doctor today.

Mr. Reed Elley (Nanaimo—Cowichan, Ref.): Thank you. We're all being given honorary doctorates today. That's all right.

Once again, I'd like to thank you very much for coming and making your presentation to us this morning. I think all of us on this committee feel that this is an important part of helping us to be educated on the issue. Notwithstanding any political statements that have been made here this morning, that is the primary purpose of this committee. We're supposed to be a non-partisan committee taking a look at this issue on behalf of the Canadian people, and that's my intention anyway.

You made a provocative statement. At least I thought it was kind of provocative. It would be provocative, I suppose, in some quarters, maybe even within the health food industry itself. You said you felt—this comes out of page 5—that the system should encourage integration with conventional medicine. I'm wondering what you mean by that. Can you expand on that and give me more of an idea of where you're going with this thought?

Dr. Frank Chandler: In the western world, as herbal medicines, natural product medicines have come back into use, there has been almost an underground current to it. We feel that there is legitimate use for these products, that they need to be legitimately controlled and that it's sort of a continuum of risk but also of usage into the system. I think a lot of Canadians would like to try the low end, low dose, maximum safety approach first and, if that doesn't work, sort of work their way through the system so that the natural health practitioners are working hand in hand with conventional medicine so the patient doesn't fall through a crack somewhere.

Dr. William LaValley: I would like to relate a few general statistics with regard to that.

In September a poll was taken—I think it was a CTV-Angus Reid poll—that showed that about 75% of the Canadian public would like to have more of these unconventional complementary health care services brought into insurance coverage in the province. Two-thirds of the public want more research funds put into complementary medicine. In a Maclean's poll at the end of the year, one-half said they are very open to and would access one of these services if they needed it.

• 1010

When you look the number of physicians in the country who are interested in these services, between 50% and 83% recognize that one or more of these services are of benefit; they will refer for these services and they want more education about them. Yet in very stark contrast, less than 10% of these physicians ask about these services or these products and how they are being used by their patients. So we have this large gap of usage and demand within the public, yet very little integration within the conventional medical field.

That allows for greater risk to the safety of the patient. The physicians are uninformed on what interactions may be occurring and the range of benefits that clearly we have in a good clinical evidence base as well as in the anecdotal base across the entire country.

When you look in other jurisdictions, in the U.S., Europe, India, Australia, South America, we see there is a beneficial impact from these products and services. The rational approach is to seek the least harmful, most beneficial integration of these in a way to promote wellness while we are seeking to prevent and treat disease. That can't be done in isolation, and it has been isolated within the conventional medical community until now.

Mr. Reed Elley: Well, can I ask you, then, and all the panel members, on the basis of what you have said, are you looking perhaps that 20 years from now, when I go to see my GP, along with the training he has received in medical college he will have received training in homeopathy; he'll pull St. John's wort off the shelf and say, you know, maybe you should try this? Is that what we are looking at?

Dr. William LaValley: We hope it will be before 20 years.

Mr. Reed Elley: Okay.

Dr. William LaValley: But yes, that's what we are talking about.

Dr. Mary Wu: I would like to give you a bit of information about what is going on in China. Even 20 years ago in China we were integrating western medicine, if I may call it that, and traditional Chinese medicine. Traditional Chinese medicine came long before western medicine, so our people are used to traditional Chinese medicine. But when western medicine got into the country, we thought, well, this is great; it's all based on science and everything is so clear. Even when I was at medical school we were studying about physiology and anatomy. We thought, this is great; we can see it and we can look at it and we can feel it, whereas when we talk about traditional Chinese medicine we are looking at more of the philosophical and logical ways of thinking about things.

So we accepted both; and do you know what happened? For patients, both kinds of medicines have advantages and disadvantages. For some conditions western medicine works much better. If you have a stomach rupture, surgery is great. You do need the surgery; otherwise the patient dies. But if you have some kind of functional disturbance, as we call it, let's say the patient feels terrible and tired and has a bit of loose bowels and also cannot sleep very well and their menstruation is not quite on a regular basis.... When you go to a western medical doctor and have dozens of check-ups, nothing is wrong. There are no positive results.

In those circumstances we use traditional Chinese medicine. We say, hey, come to me; and I look at that. Okay, all the results are negative and apparently there is no serious organic disease in this patient. Nothing is available from the conventional medical field. But there are a lot of things we can diagnose according to traditional Chinese medical theory. There is an imbalance. You feel too hot, you feel too tired, or you feel too dry. Therefore, according to Chinese medical theory we prescribe—not “prescribe”; I may not be allowed to use that term—recommend some Chinese herbal remedies.

Sometimes we use the products. At other times we just use herbs for that condition. After about a week or a longer period of treatment the patient feels much better.

• 1015

There is also a combination of western medicine and traditional Chinese medicine in terms of surgery. Before the surgery, while the patients are waiting for surgery—and sometimes it can take months of waiting—we start giving them some natural health products as well as Chinese medicine, including acupuncture. The patient feels better and gets into better condition to prepare for the surgery. After the surgery as well we give them something to accelerate the healing and recovery process after surgery.

So I think the combination of the two will work best. All we need to do is have well-trained practitioners who can recognize under what conditions it's best for the patient. We're also going to look at how, about 20 years down the road, there probably will be physicians who will get formal training in traditional Chinese medicine. That is what is happening in China. People get their MD licence after five years of medical school training, and then they go to traditional Chinese medical schools to study for another three years. We call these doctors western-traditional Chinese doctors.

Dr. Frank Chandler: I would add that the same practice of integrated medicine is quite common in western Europe at the moment.

The Chair: Ms. Bennett.

Ms. Carolyn Bennett (St. Paul's, Lib.): Thank you.

To go back to the theme of a lot of the questioning in terms of how the parliamentary committee can actually assist in making the work you've already done relevant and practical in terms of public policy, how can we help you go forward? Obviously the debate between safety and efficacy will continue. I don't think there's any question in any of our minds that safety is imperative, as is efficacy. We could spend the whole gross national product on research and still have tonnes of questions.

My question is what would you do, if you were us, to actually complement what you've done already? What haven't you been able to do that, if you had the parliamentary committee at your disposal, you would be asking us to go and do? Would that be townhall meetings around the country, just listening to users? There has been some debate as to whether this committee should travel. What would you do, if we were going to help you, to come up with the ultimate report?

[Translation]

Mr. André Gagnon: I will answer in French, because the question is much too complicated for me to answer it in English. It is a very good question.

For those of us who work in this field every day, it is difficult enough to follow what is going on. People like yourselves, members of Parliament, either have personal information, if they use the products themselves, or have information that they hear around them generally. This is a different type of decision from political decisions on justice, firearms or any other subjects such as immigration or matters of general interest.

Special expertise is required in order to understand this subject. I know you have a team of researchers to assist you, to inform you or to answer any questions you might have in order to help you make a decision. However, if I were in your place, I would have a very hard time making a decision, because I would feel that I do not have enough expertise in the area.

My suggestion is that you take into account the practice in other countries. I must repeat that the United States has an Office of Dietary Supplements, which has an operating budget from the American government so that it can hire highly skilled staff with a view to finding solutions that are acceptable both to the industry and to Americans generally.

If I were in your position, I would rely very much on the research team. However, I myself have no contact with the research team. I hope to be in touch, but there again, it would almost be a full-time job if the objective is to come up with something useful. I also have a business to look after and other things to do. In order to do the job seriously, ongoing contact with the researchers would be required. I don't know what they are planning to do. Are they going to get in touch with the TPP? Is the TPP in touch with them? I have no idea.

• 1020

What we are lacking is a way to bring all this together. In order to do a good job, all the efforts will have to be coordinated and the number of people involved reduced. We need to set objectives and deadlines. Otherwise, four groups are going to be working with no overall coordination: the TPP, ourselves, the standing committee and the researchers. That is how I see the situation at the moment.

I don't understand how all these efforts can be integrated. I fail to see how we can come up with a report on April 30. I may have an opportunity to speak to a researcher once, and I may never have another opportunity to speak to you, the committee. Moreover, I may never have the opportunity to consult the TPP. We are really talking about the internal functioning here. There is talk of establishing a new structure. Obviously, there will be resistance from the TPP. It will be told in the future that it will have no decision-making authority regarding these products. That will not be easy, but it is something we have to discuss.

In concrete terms, I look at this as a business. We have to sit down with a limited number of people and say where we want to go. That it how I would answer your question based on my knowledge.

[English]

Ms. Carolyn Bennett: As Dr. Chandler said, the expert committee are people who are passionate about this, and they feel that for the most part there is a positive effect for this approach. As people who are responsible for all Canadians, it's important that we hear all sides of this before we come to a policy. I feel that this restricted nature of committee hearings will only allow the people who have a very predetermined view to come and present to us, unless we do something like townhall meetings, where maybe somebody would drift to the meeting.

I'd like to hear from the disaffected before the policy gets written rather than after. I just feel that if we could involve more Canadians in the process.... Would you agree that would be a good idea now, or are there ways we can find this out?

I was a bit surprised that the Statistics Canada data isn't what you think it should be. I also was wondering, in terms of the last question, Dr. LaValley, whether you think we should hear also from the College of Family Physicians to see if they could help us with some strategies for the family doctors of this country to become better coaches on this matter. They may not have to have the expertise, but how do we help them coach the patient, who, I believe, is always the captain of the team?

The Chair: Dr. Chandler, could you answer the first part quickly? Then we'll go over to Dr. LaValley.

Dr. Frank Chandler: I'm sorry, the first part was what? I'm drifting off here and looking at some of the second parts.

Ms. Carolyn Bennett: Do we need to hear from Canadians in townhall meetings?

Dr. Frank Chandler: Well, certainly we need to hear from more stakeholders, including the consumer. I'm not too sure who will be addressing you. I know a lot of the various industries that you've indicated will come and will have very defined opinions. Some of those industries are represented on our panel, and we've heard some of them. We've tried to incorporate them. It's my feeling that already we're hearing greater support for the position we're taking. There may be disagreements with some of the actual policies or recommendations, but the general direction is being much more broadly accepted.

I kind of hate to say go out and do townhalls, but I do think you need to hear from consumers, from the medical and other health professions, and from the industry at large.

The Chair: Dr. LaValley.

Dr. William LaValley: When you speak about the College of Family Physicians, it brings in the whole notion that there are primary care providers, and many of them are medical doctors. However, there are others who are naturopathic physicians, some are chiropractors, some are practitioners of traditional Chinese medicine, and I could go on and on. What we're talking about is a need to have an education process, and you can recommend that. You can recommend the overarching umbrella here.

We need an additional education process for the medical licensing authorities, because if you want to speak about those who are disaffected, many of the people who are on this natural health products advisory panel are very close to or are actually those who have been the disaffected.

We need to look at educating the Federation of Medical Licensing Authorities. We need to educate the provincial government Departments of Health and make recommendations that education also be done through the medical schools.

• 1025

If now physicians are going to be the primary care providers or the so-called gatekeepers, we need to make sure they understand when it is appropriate to use or refer somebody for acupuncture, chiropractic, or any other of the various range of natural health product services or complementary services, so that we truly do integrate things that are in addition to and adjunctive to one another.

Ms. Carolyn Bennett: If I understood you correctly, did you not say that a lot of family physicians are not even asking the question in the initial history-taking as to whether or not people are using other complementary therapies?

Dr. William LaValley: That's right.

Ms. Carolyn Bennett: So in safety, we can't be there if we, as physicians, don't know what else the patient's taking before we prescribe the medication.

Dr. William LaValley: Yes, that's precisely correct. Right now, the public knows more than the medical doctors do about this, so the physicians feel intimidated. They're not willing to engage because they don't want to be seen as not understanding or not knowing.

The Chair: Thank you very much. We have to move on. We have other groups appearing after 10.30 a.m.

Madame Picard will be the last questioner.

[Translation]

Ms. Pauline Picard: Mr. Gagnon, you said earlier that we should be familiar with the legislation and regulations in countries other than the United States, because apparently it is easier to deal with the natural medicine assessment office.

You say you lack resources. I assume you are referring to human and financial resources. If the committee could afford to look for these other laws and regulations, would that be helpful to you in establishing fair regulations in this area?

Mr. André Gagnon: When I mentioned other regulations, I was not necessarily thinking of regulations in countries other than the United States. Without analyzing all the regulations, we would simply have to seek out those that could be useful to us for our regulatory framework. That is really how I would direct the information-gathering process.

It would seem that the main requirement is to have the proper expertise in order to make decisions. This is where some alliances might be desirable to help in operations or to take advantage of skills available elsewhere. The idea would be to have a network that would enable us to find this information. We would not necessarily have to analyze the legislation in full, but rather to look elsewhere for what we need in order to establish the necessary expertise and the structure.

We might have to do some analysis, but not a full analysis, because that would be a huge job. The issue really involves expertise. Rather than reinventing the wheel, we should use the expertise that exists elsewhere.

[English]

The Chair: Thank you.

I'd like to thank the whole panel for coming, all four of you. There's a good chance we may ask the panel to come back, so feel free to come back if we need you at the end or if we want to speak to you again after we've heard more witnesses.

Thank you very much.

Ms. Elinor Caplan: I'd like to say that if at any time the panel has information they'd like to share with the committee, they can feel free to notify us in writing, and then if we would like, we'd ask you to come personally. As you view your accountability to the committee as well as to the ministry, we would really appreciate hearing from you on an ongoing basis.

The Chair: Make sure anything comes back to the clerk and we'll send it to everybody. Thank you.

We'll take a five-minute break.

• 1029

• 1042

The Chair: I'll call the meeting back to order, please.

We're pleased to welcome two groups to our committee now. From the Canadian Health Food Association, Serge Lavoie and Michelle Marcotte, and from the Canadian Coalition for Health Freedom, Mike Vertolli and Valerie Dugale.

We have them in this order, so maybe we can start with the Canadian Health Food Association. Could you keep to no more than five minutes each, ten minutes for the whole group? That will give all the members a fair chance to ask their questions.

We'll start with the Canadian Health Food Association.

Mr. Serge Lavoie (Executive Director, Canadian Health Food Association): Thank you, Madam Chair. I might say that we're actually one group. We're all under the aegis of stakeholders in the natural health products industry, and while some of us work for different groups, we have come here together. We have prepared our material together and will be presenting in a certain order.

I'd like to start by introducing our group. I'm the executive director of the Canadian Health Food Association. With me is Michael Vertolli. He's president of the coalition, an herbalist, and he's also a member of the Advisory Panel on Natural Health Products. Also with us is Valerie Dugale. She's secretary of the coalition. She also works for the Canadian Health Food Association as regulatory affairs coordinator. To my right is Michelle Marcotte. She's with the Inter/Sect Alliance, a private consulting group, and we've asked her to come because she is an expert in the international regulation of natural health food products, and foods as well.

We've also asked two people to be available to answer your questions. They are Joel Thuna, who is an herbal manufacturer. He has special expertise in good manufacturing practice. He represents a small herbal manufacturer. Dr. Maureen Horne-Paul represents the Canadian Naturopathic Association and is a Kingston-area naturopathic doctor.

As you can see, we have a range of people here to represent the stakeholders in the natural health products industry.

We want to basically give you an overview of our sector, answer your questions about how we're structured, how we operate, and we also want to identify our key concerns and the effects they've had on our sector. And not surprisingly, we have a few key recommendations that we think we can put in front of the committee.

We have a briefing book for you, which I think has been distributed or is being distributed.

[Translation]

I should say that most of the documents were translated into French, with the exception of three summaries. We had some difficulties in this regard. The three summaries will be distributed and translated as soon as possible, within a few days. I apologize for this.

[English]

I'm going to kick off with just two or three moments of quick industry overview. Some questions came up about that earlier. I'd like to first talk about the size and composition of our sector.

• 1045

To begin with, there's a bewildering array of product categories. This is brought on by the fact that as a sector we look on these products holistically, whether they be vitamins, supplements, herbs and botanicals, personal care products or fresh and packaged foods. In organic products, they're part of the natural health products industry.

There's also a wide range of distribution channels where people buy these goods. Health food stores, of course, we can think of; supplement and nutrition stores, complementary medicine practitioners, pharmacies, drug stores, grocery stores, general merchandise stores and, increasingly, multilevel marketing and through mail order, phone order and now Internet ordering, a plethora of sources where one can buy these products. It has a direct effect on our regulatory environment, there's no question about it.

In terms of the size and sales of the health food sector, we've heard already that the statistics are woeful in this area—we don't have a lot of statistics—but in our industry we have begun to study our own distribution channel to get a handle on what we are selling to consumers. Our preliminary data, and it is preliminary, tells us first that we have about 1,700 retail outlets that call themselves health food stores or nutrition stores. Their total sales run as high as $680 million per year. Where the stores report to us, about $450 million of that is in the product category of vitamins, herbals, botanicals, supplements and homeopathic remedies. Now, that's just our distribution channel. It does not include drug stores, pharmacies and all the others that I mentioned. When that research is done, it's clear we will be looking at numbers that are considerably higher—I estimate probably about three times higher.

In terms of growth in commercial activity, we've asked our sector what they are experiencing in growth. What's interesting is that for the last two years our stores report to us that their average sales have increased by 24%. That's quite astounding for the retail sector. Among those stores, 90% expect their sales to increase over the next year and 93% expect their sales to continue increasing over the next five years. Clearly, it is a very buoyant market out there. They also anticipate that their sales will increase by an additional 20% over the next two years.

The growth in consumer demand is significant. Looking at the polling detail, in 1995 Statistics Canada did look at complementary and alternative medicine and reported that 15% of adult Canadians reported using some form of alternative medicine or practice. By 1997, we have three separate polls that show very different numbers.

The CTV-Angus Reid poll showed that 42% of Canadians use alternative medicines and practices, and 55% of those reported having used them for at least five years. The Maclean's poll at the end of the year showed 47% of respondents open to using alternative medicines are using them. The Canada Health Monitor reported that 56% of Canadians report taking one or more complementary medicines in the last six months. So these are significant numbers and indicate a significant shift in consumer demand even in just three or four years.

There are, as you will see in the binder, some differences by age, gender and income that I think are interesting because by far right now seniors are the largest group of users of these products, but the largest growth in a sector is with the 18 to 34 group. So it's beginning to change even along demographics.

There are clearly some implications to the health care system with this kind of growth. We are interested to hear in the Angus Reid poll that 93% of Canadians agreed with the statement that “doctor's can give advice, but people have the main responsibility to look after their health”. Clearly, that's an indicator of how people view alternative health practices; it is an empowering kind of thing.

We also note that of those reporting the use of natural health products and therapies, 80% felt that these treatments or practices are important to their personal health, 90% are satisfied with their alternative medicines or practices, and 34% of them became users because the regular medicines on their own weren't working for them. There are a lot of very interesting statements here about how consumers are viewing alternative and complementary health medicines. Put together with the commercial data we've got, I think it indicates that now certainly is the time for us to deal with some of these issues.

• 1050

The next person in line to give a little presentation is Michael Vertolli, who will talk about the nature of natural health products.

Mr. Michael Vertolli (President, Canadian Coalition for Health Freedom): Thank you.

It's funny, because both in the work we've done and in the work I've done with the advisory panel, if you were to take any given product and say to a person, “Is this a natural health product?”, in most cases you would get agreement on whether it is or it isn't, although coming up with a clear, concise definition of what constitutes a natural health product is actually very difficult and many hours have been spent by many groups in trying to come up with a definition.

We've got a definition here before you. I'm not going to read it, but in essence what we're talking about, without getting into the details, is products that are natural or come from natural sources, although they're not always, at least traditionally, and, for the most part, tend to be used within the context of a holistic medical framework.

That happens to be a very crucial element here, because one of the big problems that we have with the health care system today and with the regulatory system for health products is that the philosophical concepts that are the mainstay of this holistic medical paradigm are essentially ignored and often looked upon as being non-valid on some level.

The holistic paradigm looks upon health care in a very different way. We first of all would like to believe that, for the most part, we tend to look at the entire picture. To a mainstream medical professional, a cold is only a cold insofar as it has certain symptoms. As Mary said in answer to a question earlier, we've got a different perspective. Often people are experiencing health problems long before they actually begin to experience a clear symptomatic picture. That individual can go from practitioner to practitioner and say, “I know my body. I know that something is wrong with me. What's the problem here?”, but in many cases the types of methods that are used to diagnose these conditions are not able, in the early stages, to pick up that there's a problem. Yet many of these people, through going to natural health care practitioners or through the use of natural health products, are able to get relief and experience an improvement in their health. So one of the main differences here is that the holistic paradigm is a health-based system, whereas the conventional medical paradigm is a disease-based system.

Most of the information in conventional medicine is based on the study of diseases. In fact, in most cases they don't even have a clear, concise definition of what health is. In modern medicine health is often described as an absence of disease; so we have a negative definition. On the other hand, in the context of holistic medicine we look upon health as being the primary goal and being the natural state of people and we gear our methodologies towards the promotion of health.

In that context, many of these types of products and many of the types of modalities that are used are used in a way to promote health. That doesn't mean we don't treat disease, but we are aimed at primarily promoting health and using methodologies and substances that, to the best of our ability, work together with the human body, with the person, and promote natural mechanisms by which the body heals itself.

In contrast, many of the types of substances and approaches that are used in modern medicine and conventional medicine are instead aimed at trying to eliminate symptoms, because the symptoms are viewed as the disease in itself and it's viewed that once you eliminate the symptoms, you have eliminated the problem. In the context of a holistic paradigm, we view the problem as being much more than the symptoms. It has a lot to do with the person's emotional state, with their lifestyle and other factors. So there's not only an element of what types of products are being used, but also how they're being used.

Again, that doesn't mean that these products can't be used simply as a means of treating symptoms. They can be used in that way as well.

One of the big problems in the modern medical approach is that it is reductionistic in nature; that is, it comes from a philosophical belief that you can break a person down into various components, that is, into organs or organ systems or even right down to the molecular level, and study the effects or the functioning of the organism on a molecular level and therefore be able to draw meaningful conclusions about the person as a whole. On the other hand, from a holistic paradigm, we believe the whole is always greater than the sum of its parts, and in order to understand human beings and in order to understand health and disease you have to look at the whole person and the context in which they live their lives.

• 1055

This particular approach, this reductionistic approach, leads to a lot of regulatory patterns or regulatory structures and approaches that have reduced the availability of these types of products for the benefit of the Canadian public in the past, and that continue to reduce them. Often it's because, for instance, decisions are made based on these types of studies, where if you find that, for instance, a particular substance that is isolated from a plant and then fed to rats in massive quantities is found to produce toxic results, then regulatory decisions are made about the plant itself, in many cases without anyone having actually studied that plant and its effects on the human being.

Similarly, we have cases.... A common example, one that has been in the media a lot, is the herb ephedra, which contains a substance that has been isolated and manufactured into the drug ephedrine. In the past there have been instances where the use of this particular drug has led to toxicity reactions, in some cases very severe, and conclusions have been drawn about the effect of the herb based on these results.

In many cases Health Canada itself has perpetuated in the media the idea that this herb is somehow dangerous. It has perpetuated the misinformation that people have died from the use of the herb ephedra when in every single case where deaths have occurred the product being used was not a product that contained the herb ephedra; it was a product that contained either the alkaloid, the isolate, the pharmaceutical ephedrine, or ephedrine in combination with the herb. In no cases did deaths actually occur from the use of the herb on its own. Nevertheless, that has been perpetuated as being a reason for regulating the herb itself in a specific way.

I should add that in every case the products were actually misused. They were used in excess of the dosage that was recommended.

On that level we can see where this particular medical paradigm which perpetuates the regulatory system is being used to judge products and methodologies that come from a very different philosophical perspective. As such, the system can never really work until the essence of the philosophical concepts of holism are incorporated into the regulatory structures and the regulators themselves have the appropriate expertise to be able to judge these types of products on their own merit.

Mr. Serge Lavoie: Thank you very much.

The next speaker is Valerie Dugale. She's going to give us a perspective on some of the industry issues surrounding regulation.

Ms. Valerie Dugale (Secretary, Canadian Coalition for Health Freedom): Thank you, Serge.

I want to look at some of the conditions that are occurring, because they really start to provide us with answers to why we are all here today. Before I do that, I just want to say that in order to examine Canadian conditions, we have to be cognizant of the influence of American and global markets.

In 1994 the U.S. government passed the Dietary Supplement Health and Education Act. You're going to be hearing more about that from Michelle Marcotte in a minute. What what that did was it increased the availability of natural health products in the American marketplace and it put a greater focus on consumer health education, which meant more product information was allowed in the United States market. It's with that in context that our Canadians are gaining a wealth of information on health products and trends through American advertising and other global sources, such as the Internet.

One of the main reasons we're here is that Canadians are frustrated. They want access to products that are currently banned in Canada. Hundreds of products are available and viewed as safe in other countries, such as the U.S., but are not available at Canadians' local retail store.

Why are these products not available? Well, we pick up on what Michael was just saying about the fact that our regulatory process is applying pharmaceutical standards to natural health products, and they are just not appropriate.

Products have been banned for a number of reasons. In the 1980s, with many products coming into Canada, regulators either lacked or failed to seek appropriate information about them, so they were thrown into a category where they couldn't be sold.

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Products that consist of combinations of vitamins, minerals and/or herbs are also not acceptable. They're not allowed unless one of those constituents is limited to a non-medicinal dose. Of course, if you do that you're really diminishing the effectiveness of the product, but as it stands, combinations of vitamins, minerals and herbs are not allowed. As well, herbal and homeopathic product use by children is actively discouraged.

This has led to a situation where Canadians are personally importing thousands of products across the border with no real mechanism to guarantee safety. What we have going on right now, today, is a vast underground market in imported natural health products from the United States and other countries. Under Canadian law, Canadians are allowed to import health products for personal use up to a period of three months. So with that law in place, having gone to their local health food store and been frustrated, Canadians are purchasing hundreds of product lines direct from U.S. suppliers through cross-border shopping and through numerous mail-order catalogues.

So we have a situation in which, while Canadian retailers and suppliers are complying with Canadian regulations, they are losing a significant and growing percentage of sales each year to U.S. imports. Of course, their customer base is eroding through competitive sales tactics from these suppliers.

As well, there is really no mechanism to ensure that the products that are personally imported by individual consumers are meeting Canadian standards for safety and high quality. Certainly from a regulatory standpoint safety is not being served by current regulations that arbitrarily ban these products when they can be legally imported for personal use.

Another condition that occurs is that Canadians want but cannot get appropriate information about the products they're purchasing. In recent polls Canadians have said they want the government to require information on products, information such as safety and side effects warnings, what the remedy is for, and the amounts of each ingredient in the product.

How does our current regulatory situation respond to this? Under food labelling, if a product is classed as a food, no information is allowed on the product's benefits, and certainly not any information on how it should be used and when it should not be used. In other words, there are certain products where there should be contraindications on the label. If a product is classified as a food, you can't put that on.

Under the drug policies, information is also severely limited. There can be no information on how a product can improve the body's functions or structure, except in some limited cases, and certainly no information relating health benefits of a product to the prevention of disease.

Another condition that exists is that the sector's economic growth is being hampered by inappropriate standards, costs and policies. The regulatory process as it currently stands does not recognize that there are some key differences in the natural health products sector and its structure, the key there being that most natural health products are non-patentable. There are simply fewer resources available for research than with those firms that sell patented products. Cost recovery fees, which are currently charged on a per-product basis, are cumulatively more onerous for natural health products suppliers, who tend to carry very expensive product lines so that they can meet the many needs of Canadians in this area.

What happens is that when regulators, who were accustomed to pharmaceutical double-blind clinical trials costing $200,000 or more, ask for scientific evidence of a natural health product's proven efficacy and safety, well, the natural health sector is hard-pressed to respond.

As well, the directorate has extreme latitude in classifying products as drugs. The definition is very vague. It's vague enough to include items such as chilli pepper and garlic. The end result is that suppliers are overregulated and overcharged for such services.

Finally, industry expertise is not matched by the abilities of those regulating natural health products. As you've heard, there is a whole profession schooled in the practices of natural products and traditional medicines. These professions are not represented in the therapeutics products directorate. This has resulted in a regulatory environment fraught with confusion.

Our group, as a number of stakeholders, has come up with a number of solutions to these issues. We'd be very pleased to share them with you during the question and answer period.

Thank you.

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Mr. Serge Lavoie: Thank you.

Our last speaker is Michelle Marcotte, who is an expert in international regulations. She's the co-author of a comparative analysis of regulatory frameworks around the world. You have a copy in your binders. She's just returned from a fact-finding mission to Australia, where she's got updated information on their regulatory environment.

Ms. Michelle Marcotte (Canadian Health Food Association): The relationship between consumer demand and expectations for health products and government systems under which such products are regulated is rapidly changing worldwide. Regulatory issues in the natural health product sector have created research and development constraints; impediments to advertising, promotion and legitimate health claims; and barriers to market access and international trade.

These constraints are collectively restricting consumers' choices and their access to information to which they're entitled.

Some countries have already responded by altering traditional regulatory systems to advance their natural health product industries. In doing so, they have recognized consumer demand for self health care products, the need for better consumer information and the economic potential of health products that are essentially highly valued-added agrifood commodities.

In the United States the Nutrition Labelling and Education Act, or NLEA, provides a process for approving health claims for foods and provides for greater consumer nutrition information on foods. Several health claims associating foods or food groups and disease or wellness issues are already approved. The efficacy data requirements allow for significant scientific agreement, a less onerous requirement than scientific consensus. New legislation indicates significant scientific agreement is also achieved when a major U.S. public health organization has approved a nutrient and disease claim relationship.

The Dietary Supplement Health and Education Act, or DSHEA, assumes dietary supplement products are safe and can contribute to improved public health. Dietary health products are allowed to be marketed with only a 30-day pre-market notification. DSHEA allows the use of approved health claims under NLEA. DSHEA also allows structure function claims, product claims that alleviate nutrient deficiencies where the prevalence of the disease is disclosed, claims that describe how the product works in the body and claims associated with general well-being. Unless NLEA approved claims are used, a disclaimer statement is required.

As we've heard this morning, DSHEA also set up an office within the National Institutes of Health and a presidential committee to review the health claims issue. That final report is now available.

In Japan the Japanese Nutrition Improvement Act provides for the approval and labelling of special nutritive foods, enriched foods and foods for special dietary uses. The FSHU foods designation, or Foods for Specified Health Use, allows manufacturers to establish a basis for health claims. The principle behind FSHU is to discover active components having certain health benefits in ordinary foods that are recognized as safe as a consequence of reasonable history of actual consumption. Thus, the level of documentation and evidence required is much less than that required for food additives or pharmaceutical products.

The Japan Health Food and Nutrition Food Association is authorized by Japan's ministry of health and welfare to provide guidance and first-level approval to Japanese manufacturers for the licensing of FSHU foods. This co-regulatory approach shortens the regulatory process for association members.

FSHU foods must satisfy eight criteria, including demonstrable benefits from consumption as a food in ordinary dietary use.

Under European Union directives health claims are not permitted, but there is considerable variation and tolerance for health claims under the regulatory systems of individual countries. As a result, the EU is currently surveying states and reviewing its position. In actual practice, each country, and sometimes each region within a country, has its own regulations and enforcement. In general, natural health products are widely available, and health claims are made on product labels in some countries. Regular and specialty pharmacies diagnose and dispense a very wide range of dietary supplement products.

The Australian regulatory system can be viewed as a very well functioning one. Australian regulation requires herbal products to be listed in the drug registry. Drugs must be registered, which is a more rigorous process. The Australian therapeutics goods administration has accomplished the listing of 1,800 herbal products and 6,000 to 7,000 OTC products in seven years.

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Products available before 1991, when this process started, were presumed to be safe, so safety data are not required. Efficacy is judged in part through the use of advisory committees whose members are qualified to assess herbal products.

Health claims—dosage, contraindications, ingredients, etc.—are all allowed on herbal product labels. Health claims for foods, however, are not allowed in Australia.

Approving health claims for holistic products is a co-regulatory process jointly administered by industry and government. Listing costs only $220 and has a one-time fee. The pre-market approval process takes only twenty days before the product can be marketed. The listing process is done electronically.

Your binder contains a full report on the Australian regulatory system and the report reviewing in detail the regulatory framework for nutriceuticals and dietary supplement products in Canada, the U.S., Japan, and the European Union. It was produced for Agriculture Canada.

I have brought some examples of Australian health care products so you can see the labels. You can see it is possible to have credible, informative, consumer-level labels for these products, including for combination products.

Mr. Serge Lavoie: They are all still under seal and they were brought in by private importation for research purposes only. But they are very interesting.

That concludes the formal part of our presentation. Our experts here, and I hardly count myself among them, will be available to answer any of your questions. Thank you.

The Chair: Could I ask that you make available to the clerk any material you think would help us in the work we're doing. I don't mean things really thick, but within reason, if you could send us material you think any of us—

Mr. Serge Lavoie: Beyond what is in the binder?

The Chair: I know we have the book, but anything else. You've mentioned some things that may not be in here. If in the next three or four weeks you have anything you think we could use, please make it available to us.

Mr. Serge Lavoie: Absolutely.

The Chair: Mr. Hill, do you want to start?

Mr. Grant Hill: Thank you for your input.

Michael, you mentioned that you have input into the advisory panel. I presume you are this group's individual who gets to make your feelings known there.

Mr. Michael Vertolli: You might say that, yes.

Mr. Grant Hill: Are you satisfied with your input? Have you had enough time to get your feelings heard by the advisory panel?

Mr. Michael Vertolli: I'm a member of the advisory panel. I'm not somebody who just reports to them. I'm actually one of the members.

Mr. Grant Hill: Okay, I wasn't clear. Are you satisfied with your input into the advisory panel?

Mr. Michael Vertolli: I would say that given that we were originally given a one-year mandate and were expecting to have that full year to prepare our report, we've achieved quite a lot. But it is a work in process and it's going to take a bit more work to get it to where we would like it to be. But for the most part, yes.

Mr. Grant Hill: All right. Where would you like to end up if you could make your feelings known?

Mr. Michael Vertolli: In the broad framework?

Mr. Grant Hill: We heard this morning about the direction towards another regulatory mechanism, another bureaucracy. Is this the direction you yourself feel is appropriate?

Mr. Michael Vertolli: We feel the current situation is similar to one where you might have plumbers regulating electricians. We have a situation where people who are trained in the modern, western, conventional, reductionistic medical model are attempting to regulate products that aren't necessarily used in that way and are generally applied from a very different philosophical perspective. We therefore believe the people who are doing the regulating should have the appropriate expertise in areas such as herbalism, naturopathy, and homeopathy, and that the regulatory system should be structured such that the views and decisions of the experts cannot be overridden by other individuals who might not have appropriate expertise, or who, coming from a different philosophical perspective, might even be hostile to that philosophical perspective, as is the case in some cases.

Ms. Valerie Dugale: May I just draw to the committee's attention that the recommendations from this group are listed on the very back page of your binder.

Mr. Grant Hill: Michelle, this might be tough for you, but I would love to know which country you think most closely approximates what your group would like to see. Which country should we look at?

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Ms. Michelle Marcotte: There are some good points from a few different countries. We have the scope and ability to prepare a made-in-Canada solution, knowing and taking the best points from several different areas. DSHEA functions very well for dietary supplement products in the United States, and so does the Australian listing process for dietary supplement products. But if we are going to also consider—and we should be considering—foods, or products that more closely resemble foods than supplements, then we should look at the Japanese system.

There isn't any one country whose regulatory system we can just buy and say everybody's going to be happy with that in Canada, but there are some countries that have definitely resolved some of the issues we are grappling with, and we can go to them. We can go to the Australians, we can go to the Japanese, and we can go to the Americans and take the best from them.

Mr. Grant Hill: I asked the regulators if the enforcement mechanisms involved police powers here in Canada. They denied this. Do you have any comment about that?

Mr. Joel Thuna (Global Botanical Inc.): Could I ask you to elaborate a little bit on that question?

Mr. Grant Hill: I have reports and pretty good information that RCMP have gone into health food stores and taken computers and supplies of product from the stores. That was denied by the health protection branch enforcement individual.

Mr. Joel Thuna: That would be incorrect. We do have documented proof that the RCMP has been involved in seizure of finished goods, goods in process, and manufacturing and bookkeeping equipment along the lines of computers, not necessarily from retailers but more from manufacturers and distributors. The RCMP is very rarely used, but there have been many police agencies involved both at the retail and in the wholesale distribution channels at various times.

Mr. Grant Hill: Thank you.

Dr. Maureen Horne-Paul (Canadian Naturopathic Association): Also, I believe there have been several instances where products have been removed directly from offices of naturopathic physicians in Canada.

The Chair: Thank you.

Ms. Bennett.

Ms. Carolyn Bennett: One of the things the committee is concerned about and knows we'll have to look at is the whole issue of claims. It was interesting to see on the bottles from Australia that whereas one, the B6, says it may be of benefit for PMS, on Cystitis Relief, “relief” being in the title, it does say it's a formula for relief of the pain and burning sensation. On evening primrose oil, it actually has indications for use.

My question has always been on efficacy, because clearly when you make a claim, it moves into a different thing in almost any regulation. What would be your suggestion for how we tidy this up? Should all the claims come off the labels and should they have a naturopathic practitioner coach them through the process? Would that be the simplest thing for us to do? What would you suggest?

Mr. Michael Vertolli: In fact it is our view that claims are essential. In order for people to be properly informed about the use of a product, they should know what the product is used for. That doesn't mean we believe we should pass a regulation that says all products should have claims, but we do feel that is important information and the Canadian public should be privy to knowledge about the proper use of these products.

The big question is what should be the basis of the claims? Where we're also very much in disagreement with what has gone before is we don't feel that double-blind clinical trials are the be-all and end-all. There is available to us a broad base of traditional knowledge from various traditional systems, and that information is valid and should be able to be used as the basis of claims as well, as long as the label states clearly the nature of the claims.

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In other words, you could possibly have a claim that says St. John's wort, for instance, has been shown through clinical studies to relieve the symptoms of depression. However, we would also accept the claim that St. John's wort has traditionally been used as a sedative, or for the symptoms of sleeplessness.

We're of the belief that you can have different data from which these claims can be made and they're all equally valid.

One of the problems we have today is that we have virtually legislated in this country a belief system that modern conventional western medicine is the be-all and the end-all and that other systems are valid only insofar as they can be explained in terms of the concepts and the research methodologies of modern medicine. We believe that this is false, that these traditional systems of medicine are valid and that they need to be judged on their own ground, not in terms of referring them to conventional medicine.

Ms. Carolyn Bennett: If we had people like yourself on a regulatory body, if somebody put out a product with an absolutely ridiculous claim, what would you do?

Mr. Michael Vertolli: Obviously, I wouldn't allow it.

Ms. Carolyn Bennett: How would you sort that out for the Canadian people?

Mr. Michael Vertolli: There are different ways in which you can sort it out.

On the one hand, we can have references that are used, both conventional and scientific as well as traditional. Within each field of holistic practitioners, there are general references that are considered to be valid.

Secondly, there is the issue of practitioner consensus. For instance, you could have a body consisting of naturopaths, herbalists, homeopaths, whatever, that could be referred to, saying So-and-so wants to make this particular claim for this particular product, is this a valid claim? From the benefit of their own personal and clinical knowledge, they could comment on that, based on their knowledge of the traditions of their system and their experience.

Ms. Carolyn Bennett: You feel, Michael, that there is wide consensus within the practitioners on these things and that the Canadian public would be well protected by that.

Mr. Michael Vertolli: Definitely.

Ms. Valerie Dugale: Just as a caveat, as an addition to that that comes back to Mr. Hill's point, with a simpler notification system many of these claims, the majority of them, could be processed very simply. We need some system in place to deal with more complex claims, but the fact is the regulatory system can be much more simplified so it would serve all ends.

Ms. Judy Wasylycia-Leis: The thing I worry about is that because there have been some well-known incidents of unnecessary restrictions on certain natural health products, and because there's a lot of misinformation floating out there, what we're hearing from folks is, get rid of the whole health protection branch; get government off our backs. That's obviously something you're not saying, but I think what you're saying is that unless we act fairly quickly to put in place a regulatory system that operates on a different definition of health, as a holistic, wellness model, and unless we have effective procedures in place, we're going to end up with a worse situation than we had before.

I wouldn't mind a general comment on that. How do we deal with folks who are saying we should get rid of everything and not have any government at all involved in this whole area?

Secondly, with respect to the panel's recommendations, are you generally in support of the development as listed here, a separate structure within government to deal with natural health products, that we rescind schedule A of the Food and Drugs Act, that we move towards a system where all products require some form of licensing with appropriate penalties in place and look at some of the other recommendations around labelling and so on? I need a general sense from you about those general recommendations.

Mr. Serge Lavoie: I'll make one general comment, that the basic recommendations and the framework from the panel are remarkably consistent with the recommendations that we've been putting forward and are in the binder. That's the first thing to be said there.

Ms. Valerie Dugale: We seem to be on the second point first, but I'd like to add to that. I'd hoped that we would be able to address your earlier point to the advisory panel.

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I think the purpose of this committee is called political will. There have been recommendations in the past. There were two advisory panels on herbal preparations in the 1980s and one in the 1990s. There have been many presentations for change to the food and drug directorate. The issue has become that not enough change occurred. Because of the lack of expertise, there was not an ability within the directorate to understand what types of changes were needed and why they were needed.

This is the first time we have been able to come forward and speak with people, other than the regulators themselves, who are placing so many arbitrary powers on this regulation, and have been able to speak in a broader forum to elected officials, to say here are the problems, could you please listen to these problems and help us articulate these issues to the Canadian government and to the regulators and bring about some change. Political will is a very important part of this process.

Mr. Joel Thuna: To the first part of your question, a second dynamic is going on right now. Canada is in a unique position in this industry. Internationally, people love our products. We hear it all the time. People don't want the American products because they are American. People don't want the European products because they see them as being pharmaceutical even though they are natural. Canada fits right in the middle there. They still look at us as pristine, clean, neat. Everyone sees the Rockies or Algonquin Park, and they think that's downtown Toronto. But that's okay. I can only dream.

The problem is, as the regulations sit today, they are hampering not only the business end of this within Canada, they are hampering us in the international field. There are many products and regulations that just force us to be uncompetitive on an international scale. In the long run that is costing Canadians jobs and a great deal of money.

Mr. Serge Lavoie: I just want to finalize my point by saying that while we have remarkable consensus on the framework, and I think that's really heartening, the devil is always in the details. We're concerned that as we move into the process of actually defining how this framework will be put out there be a recognition that there's a body of expertise and professionals in our sector who have been doing this for a long time and have the information and whose input is valid. If we can get a recognition of that as we go into this process, maybe the frameworks will work. If we don't get that, if we get a continuation of any sort of paternalistic approach in regulation, this will fail.

Dr. Maureen Horne-Paul: I would like to reiterate that point from a professional standpoint. There are many licensed naturopathic doctors who are extensively schooled in natural medicine. That's what our training is. It takes seven years to become a naturopathic physician. In order to be licensed we are board-licensed by the Province of Ontario, and we've actually been licensed to practise in Ontario since 1925.

We also have the position that we need a separate regulatory framework that includes botanicals, homeopathics, and all those types of medicines, because they are so different from conventional pharmaceutical drugs. As a profession we need to be involved in this, because we are trained, we are licensed, as are many other alternative health care practitioners, not only in Ontario but in Canada. Also, we feel it's important for the people in the regulatory position who are making the decisions to draw on the knowledge we have available as a profession and to draw on the research out there, available, when they are making decisions on the regulatory aspect of this whole issue.

The Chair: Mr. Volpe.

Mr. Joseph Volpe: Like many others, I'm fascinated by the discussions that can develop around this topic, and that do develop. This morning on more than one occasion we heard about the issue of regulations. I'm wondering whether we've given any thought to some of the ramifications of changing those regulations, especially as they pertain to—and I'll use a word I think Michael has used a lot—the coordination and regulation of practitioners.

If anything, the public must have, aside from the labelling issue, some sort of guarantee that the individuals who are making a diagnosis—because I guess that's what it would be—in order to recommend a particular dosage, have undergone some type of process that will give everybody a sense of comfort.

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I know we've just heard that naturopaths go through a seven-year preparatory period. I'm wondering whether there's an interdisciplinary body that, as far as you're concerned, would give the public the level of comfort required so that when we pick up one of these bottles you've passed around and pop one of those things we're not doing greater damage than what was there before.

Ms. Valerie Dugale: To set the context, before Michael gets into the nuts and bolts of this, the committee should be aware that the National Association of Pharmacy Regulatory Authorities recently went through a very long process to harmonize the provincial drug schedules across Canada. In their final report, which came out last year, they had four classifications for products, from prescription right down to unscheduled—“unscheduled” meaning it didn't need to be dispensed with advice from a professional. The majority of natural health products fell into that unscheduled category.

Earlier, Elinor, you were asking about whether there is a difference between products that are sold in health food stores or drug stores and so on. No. I think those drug schedules—and this is the National Association of Pharmacy Regulatory Authorities—do speak to that issue.

I simply wanted to provide that context.

Mr. Michael Vertolli: I see two levels to this. First of all, we have the issue of the expertise that's inherent in the field. Then we have the issue of what was brought up by the advisory panel earlier in their recommendation that there are some natural health products, albeit a small percentage of them, that are of a higher risk. We do feel they are still of benefit to the Canadian public, but because of their higher-risk characteristics they should be administered by a qualified practitioner.

There was a lot of discussion about medical doctors, but what wasn't acknowledged in that, and what is acknowledged by us and by the advisory panel, is that most of the individuals out there who have the expertise to use those products are not medical doctors. So it creates a problem.

Mr. Joseph Volpe: Let me interrupt you, Michael. The converse is true as well. Especially in the city I come from there are a lot of western-trained medical doctors who claim they have expertise in non-western—i.e., traditional—applications and who also diagnose and then recommend off-label use of particular products or substitute a particular pharmaceutical product with a natural product while not being certain as to the consistency and the quality of the product they recommend. I say “not being certain” because the way they're available, you can't predict with the same kind of certainty the dosage.

What do we do in cases like that? Even going further, Michael, in terms of the situation where you have western-trained medical practitioners who also experiment with many of these products, they could make a claim for some cures that a public looking for a quick fix would readily accept.

Mr. Michael Vertolli: The issue of standardization of the product has nothing to do with practitioners. That has to do with manufacturing issues, such as GMPs. That is really an industry problem. That's why there needs to be regulations in place to ensure that the products are safe and effective, or at the very least safe and what they say they are, because we have those problems. That's the most important argument for why we don't want to throw the entire regulatory structure out of the window. We know where there's money to be made people will do it through dubious means. If there are no regulations in place, there's going to be a lot of crap on the market.

At the same time, with regard to practitioners we have a very touchy issue. There are medical doctors who are using natural health products, and some of them very well, but in many cases there are medical doctors using them inappropriately because they don't have the appropriate training.

We've seen that problem with respect to traditional Chinese medicine, where medical doctors want the right to be able to use acupuncture. Many of the traditional Chinese therapists are saying, no way, if they want to use acupuncture they should be trained in traditional Chinese medicine. To a degree that's true, but we have to remember that there's a flexibility here.

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St. John's wort can be used in a holistic context. It can also be used in a modern medical context. In that sense, by substituting St. John's wort, which is much safer than a conventional anti-depressant, that is definitely of benefit to the patient. But when it comes to regulation of practitioners, that's strictly a provincial issue and it has to be looked at.

It's very difficult, because all of the different types of practitioners out there come from a wide variety of traditions and it's difficult to put in place a regulatory framework for the practitioners that doesn't unnecessarily restrict them in the context of the tradition in which they practise. Nevertheless, it's something that needs to be done.

It is our hope that the federal government, in trying to implement regulatory change, will attempt to work with the provinces and the various practitioner groups to try to bring that into place, for the benefit ultimately of the end consumer, so we can ensure that not only the products but also the practitioners themselves have some level of regulation.

Mr. Reed Elley: Some people have expressed a concern that if indeed we had a separate regulatory body under the therapeutic products directorate, this wouldn't be the most cost-effective way to handle this sort of thing, that indeed it should simply be put under the therapeutics product directorate and that people who are qualified should simply be put side by side with those who are already qualified to do testing on drugs.

I would like to have your opinion on that, how you feel about that. Perhaps you could sort of visualize a schematic of the department and where you would place what you would like to see in that schematic, with some comment on lines of authority and those sorts of things.

Do you understand what I'm saying?

Ms. Valerie Dugale: If you will refer to appendix B, which is the last page on our stakeholder recommendations, what we really are recommending is that the solution must be a separate regulatory administrative unit, that this unit would be under the authority of Health Canada and functionally integrated with the deputy minister and the Minister of Health, the therapeutic products directorate, the foods directorate and the Canadian inspection agency, because all of those groups have an interest in this area.

Because of the extreme difference in skills required, it must be a separate regulatory unit. I believe the problems that have been caused by the current regulatory system, and certainly the lack of expertise within the therapeutic products directorate, and the food directorate as well, have led to a regulatory environment that's fraught with confusion. So I think it's important that certainly our recommendations call for a separate administrative unit that has a final authority, that once decisions are made on protocols or whatever, on policies, they are the final authority, that it does not come back into the therapeutic products directorate. I say this because the people in that directorate have expertise of an entirely different nature; it's well respected, but it's not the expertise that can help with these products.

Mr. Michael Vertolli: I'd like to add that we could create the best regulatory framework possible, but if the individuals who are applying it don't understand the nature of what they're applying, then it's not going to work.

We have not made a statement—and, by the way, neither has the advisory panel—as to where that regulatory unit should be. The statement is that it should have the appropriate expertise and it should have the ability to make regulatory decisions that are not overridden by individuals who do not have appropriate expertise. If that can be developed within the context of the therapeutic products directorate, great. If it can't, then some other structure needs to be created.

At the same time, it's important to note that if suddenly the individuals or the regulatory structure that's currently regulating all “therapeutic products” has 20%, 30%, 40%, 50% of its products now being regulated by another regulatory structure, then there would be concern for the cost of that. But it would only seem logical, then, that if that regulatory structure had less to deal with, resources should be diverted from that structure into the new structure. It doesn't mean we have to go in there and create another thing from scratch and leave the old system in place undisturbed.

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Ms. Michelle Marcotte: One of the things we should try to avoid when we're setting up in detail how it's going to work is we should also be considering food products, nutriceuticals, functional foods, not just trying to resolve these issues for things that could be considered dietary supplement products but making sure we have a system that is also going to deal with health claims for food products or specialty food products. In that way we would avoid the problems that Australia has and that DSHEA has set up, which assists just dietary supplement issues.

The Vice-Chair (Ms. Elinor Caplan): Ms. Carroll.

Ms. Aileen Carroll (Barrie—Simcoe—Bradford, Lib.): Thank you. It may be that part of my question has been answered, but I would like to ask this of Joel Thuna.

As a small manufacturer, Joel—and we've obviously had some discussions on this, relating to former advisory committees and their reports, what do you see as the main impediment to you in the Canadian business culture? You touched on the problems with exports, but given your response to that on what the main impediments are, what do you see as the key goal for this committee, which we discussed earlier, and by implication perhaps the advisory committee?

Mr. Joel Thuna: There are a whole bunch of impediments, but the two main ones would be derived from the lack of expertise within the therapeutic products programme, HPB, or whatever you want to call them, and the lack of realization of the different types of market.

For example, if you flip open your binder to tab 11 on page 8, there's one correction to make, but I think it will make my point rather clearly on the differences. If you look here under the section on application for DIN, where it speaks of an annual renewal fee if the gross profit is over $20,000, please change the word “profit” to “sales”. There's a big difference.

What I'm trying to show here, and what we're trying to show.... Take for example a product such as echinacea. I'm sure most of the people in the room here have heard of it. If I'm going to get a DIN for echinacea and then subsequently sell the product as a manufacturer, excluding my costs of product manufacturing, labour, my building, whatever, I've already lost in excess of $22,000 to $23,000 in the first year. That is a lot of money just to throw away. I'm getting very little for that in service or—

Mr. Serge Lavoie: Would you explain why?

Mr. Joel Thuna: Okay, I'll go into that.

I have to pay $720 to the government through the TPP just for the right to apply to get a DIN for legal sale. Then if I sell $20,000 worth of product in the first year, I have to give $5,000 to TPP. On top of that, I have to pay them to come out to my building to look and make sure I'm doing things properly, when they don't even know what properly means, because they don't have any experts. On top of that, I have to outfit my building as though I'm producing a pharmaceutical product. I have to build clean rooms which have to be explosion-proof. I have to build machinery out of stainless steel.

Some of this is a practical concern—I'll admit that—but you're going way overboard. It's like trying to kill a fly with a sledgehammer instead of a fly swatter. Yes, there are practical concerns of cleanliness, etc., which have to be addressed with GMP. But GMP and the regulations regarding it and the fee structure, both to maintain GMP standards and to pay the government to watch me do that, are exorbitant and ridiculous.

For some companies, such as myself, which carry in excess of 3,000 products, the fee structure is so gargantuan that should site licensing have gone through the way it was going to go through, you would have been my single biggest payable. For my company the Canadian government would have been a larger payable than any other. There's something wrong when that happens.

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Ms. Aileen Carroll: I think the question is important. I know that we are trying to deal with a huge array of issues, but we only have the opportunity to hear from these experts today. So I did want to bring that to the attention of this committee, because as a small-business person, it overwhelmed me when I first heard about the whole process.

The Chair: Mr. Myers.

Mr. Lynn Myers: I wanted to pick up on the cost recovery policy of Health Canada and the three types that are presently in place. I think you started to give some examples of where this is actually affecting and how so and to what extent. I wondered if you could articulate which of the three policies, with respect to cost recovery, is the most onerous. Secondly, what is the impact in terms of employees laid off or affected in whatever way? That was alluded to. Third, what would be a reasonable cost recovery fee? I think the Australian model was talked about, $220, as I understand it. I wonder if those could be addressed under that cost recovery scenario.

Mr. Serge Lavoie: It's very hard to ask an industry how much it's willing to pay for this—

Mr. Lynn Myers: Well, in your opinion.

Mr. Serge Lavoie: And $220 sounds a lot better than $720 plus $500 a year. But the question always remains, how much does government have to collect out of it? That $220 goes to cost recovery at 50% of the agency in Australia. I'm not sure what the percentage is in Canada. That's a very difficult question.

In terms of the impact on a company, I think Joel probably has some comments on that, and Valerie. Do you have a couple of things you wanted to mention?

Mr. Joel Thuna: I'll start with what I'd be willing to pay. We'll start with that one because that's a fun one to answer.

The problem, as I see it, is if you look at the DIN fee here of $720, you have to remember that DIN fee covers any DIN. For example, you get a company like Glaxo Wellcome, which has done a huge amount of research on a product and brings in twenty to thirty skids filled with boxes four feet high of material for a therapeutic products program to go through for Lord knows how many people and Lord knows how many hours. It's the same fee for them—the $720—as it is for me, who is handing in a piece of paper or maybe seven pieces of paper on a product that's been available for 2,000 to 3,000 years. What we're doing, effectively, is forcing small companies such as myself to cross-subsidize large companies providing products that, yes, are vital, but if you're doing the work for that product, build that product accordingly.

I'd be willing to see something in the range of $200 to $300. I think that's justified. I do. I believe that the work involved properly would require that amount of money to do. I don't think it's viable when we're talking several minutes to check off two references that both the reviewer and myself know are going to be accepted from day one. I do believe that's exorbitant, if not almost criminal.

The effect on a company is to obliterate it. I know of several manufacturers that in recent months have stopped producing herbal products, not because there was a product problem, not because there was a lack of demand or lack of profitability, but because they could not afford to pay the Canadian government. That is a very sad scenario on the Canadian standpoint.

Mr. Serge Lavoie: I'd also like to point out that if we're talking about fee for service then it should be a fee for service: there should be a schedule of fees for certain services rendered. I think the concept of a percentage of sales is a tax. It's not a fee for service. It's never-ending even if it's a sliding scale amount. It's very hard to relate that percentage of your sales to the service you're getting back from your regulator. I think putting some sort of schedule of service fees together, saying site visits cost x and application fee reviews cost x, makes some sense and can be related back to the task involved and the benefit derived.

Mr. Lynn Myers: So the establishment licensing fee is the worst offender, in your view—is that what...?

Mr. Michael Vertolli: The redefinition of products from the foods category to the drug category and therefore the requirement for the company to meet drug GMP was a really big problem. It can involve major changes to the construction of their facility, the kind of equipment they use. It just goes on and on. And those standards, although standards are necessary, were not necessarily always applicable to the types of products that were being manufactured.

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Mr. Joel Thuna: Site licensing, as Mike was saying, pretty much had a double effect: one was to get up to the standard so you could be inspected and have a reasonable chance of being accepted; and then the second was the actual fee structure itself.

Our industry is rather unique in the fact that to satisfy our clientele the majority of companies out there don't handle the 15 or 10 products that you hear about every week—the St. John's wort, valerian, the echinacea, the gingko baloba. They handle thousands of products, if not in some cases tens of thousands, because that's what the market demands: people want to go to one source for the majority of their products.

When it comes to site licensing, that gets horrendous. The fee structure just escalates dramatically. Companies such as myself, which are very small—we only have around a dozen employees—are looking at a minimum.... We never did get a final bill, but we were looking at a minimum of $25,000 the first year. That's on top of the upgrading of our facilities. That stopped us cold from investing in our company. As I spoke to my MP about it, I got so angry about it we actually stopped investing. We had worked out deals with two universities to have an ongoing functioning lab in our building. When we heard it was going to cost us in excess of $10,000 a year just to have it sitting in our building, on top of all the other costs, we just stopped.

Many companies have stopped investing in themselves in the past year and a half, let alone external investment, let alone hiring. I know many companies that were looking at doing a third shift stopped it. I myself was looking at a second one and we halted it all. There's no point investing in a company that you don't know will be viable.

Mr. Serge Lavoie: Just one quick supplementary there. While I'm not a manufacturer, given my position I get a lot of phone calls from bankers, securities analysts, people doing due diligence on applications for funding of various kinds. The first question that always comes up is what's the effect of the regulatory environment on the future growth of this industry. They don't ask to know what the pro formas are; that they can figure out. They're always asking the one question: We hear a lot in the press about this regulatory environment; what's the effect on the future sales of this product; what's going to happen to this product?

The environment is so up in the air and it's so volatile that it's very clear it's having a negative impact on investment, both from within companies and also from people willing to bring venture capital into the industry.

Mr. Lynn Myers: Madam Chair, I just want to make the point that I think it's really important that we as a committee hear that.

The Chair: Yes.

I'd like just to add a little comment here and play devil's advocate a little bit. You said there's a problem getting up to the standard financially to get the GP number, the equipment, etc. Is the public going to be happy if you're not up to standard? You're saying it's a problem getting up to that standard. You're saying that standard is too high. Are the public expecting a certain standard in order to be able to go in and say I can safely buy this, it's met a certain standard? I'm talking about the DIN number.

Mr. Joel Thuna: A certain standard is fine. I don't know of any member of our industry who is not asking, if not begging, for an appropriate standard. That is the key word—an “appropriate” standard. I don't feel that a company such as my own or any other firm doing natural supplements should be held to the same standard of pharmaceutical manufacturing that someone like Glaxo Wellcome, which actually produces injectables and highly toxic products, should be held to. I think that's highly inappropriate from a monetary standpoint or required from a safety standpoint.

The Chair: Thank you.

Ms. Valerie Dugale: I'll just point out that we are asking for appropriate GMP. The current GMP are designed for pharmaceutical firms. They cannot even be practically met by members of our industry because of the different manufacturing processes and structure. This situation has also led to an inequality in enforcement right across the country, because even when the inspectors go out they know they've got to make unofficial concessions because they've got GMP that don't match the manufacturing standards. So we've had quite an inconsistency in enforcement. So one of our recommendations is we need appropriate GMP to be redone.

The Chair: Ms. Wasylycia-Leis.

Ms. Judy Wasylycia-Leis: Thank you. I have two questions.

Some people have suggested to us that Canada can't do this in isolation of developments around the world, and that there need to be some international developments happening, some harmonization of approaches in this area. Of course there's a downside to all of that, too, given some of the trade agreements and so on that we're faced with.

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My question is this. What is happening, from your point of view, in a positive way, either through the World Health Organization or other efforts, to try to achieve that kind of desirable worldwide framework?

My second question is this. If we are truly to see this whole area as an opportunity for shifting our health care system towards wellness and disease prevention and therefore a more cost-effective system, do we not need, within government, more than simply a separate regulatory framework with regulators who are trained in the natural health product area to be good police officers or whatever? Do we not need, within government or somewhere, the capacity to be proactive, to promote natural health products for the good of our health care system as a whole?

Mr. Serge Lavoie: I'll tackle your second point and then ask Michelle to tackle the first.

The title of the American legislation, DSHEA, which is Health Education, says it all. It's a proactive document that is a vision of self-care for Americans. They are being empowered to get the information, whether it be from the label, from books, or from practitioners, and to work with these medicines and take some sort of responsibility for their own medication.

The legislation is a key point in how it promotes use of these products. That's something we have to take a look at. It's more than just a regulatory change. It's a whole shift in vision that we're talking about here.

On the regulatory front—

Ms. Michelle Marcotte: From a really practical viewpoint, there's probably nothing much happening at the international levels you're talking about—the World Health Organization or Codex, which mostly deals with food issues—that is going to assist you.

What we do see are some countries that have worked to try to improve their domestic situation first. In many cases they see that the manufacturing side is something they would like to develop from an economic viewpoint. A lot of these products are agrifood products and can make significant contributions to the rural economies. So they have tried to put their domestic regulatory situation on a much better footing. Then from there, internationally there can be more discussion about systems.

But we do see several similarities. We see that there is coming in certain countries a much more general acceptance of dietary supplement health self-help products and an understanding that you have to have health claims, and credible health claims, on the label. You can't just have a product that doesn't tell the consumer what it's for, what the dosage is and what the contraindication is. So we see those similarities.

We need to move more towards that kind of system in Canada. Otherwise, when the international situation does start moving, we're far, far behind.

Mr. Michael Vertolli: I'd like to comment on your second point, because it's a very important issue, and that is where the holistic paradigm and natural health products fit within the overall health care system.

Ultimately what we have to recognize here is that who we are responsible for in the end is the Canadian public. We want to ensure that everybody in Canada has access to the best health care system available.

We have everything on a continuum here. We have people at one end who use nothing but natural health products, we have people who use nothing but pharmaceutical products, and we have probably the majority of people in Canada who use both. What we have to recognize is that for the end consumer, what they need is to be able to benefit from all the different approaches available.

Modern medicine has made incredible advances in the areas of surgery and emergency health care, but its record is pathetic for chronic disease, whereas many holistic paradigms do very well in the treatment of chronic diseases. So obviously the end consumer is going to get the best benefit if they have both.

Secondly, if we move towards a more proactive health-oriented system that is focused more on education and prevention, it's going to be much more cost-effective. I haven't used medicare in 20 years. Not everybody has the level of knowledge I do, but I see many patients every week who also are using the system minimally and who are taking a more proactive approach to their own health.

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I think in the end what we're trying to work toward is a health care system that works and is affordable, and we don't have that right now.

The Chair: I'll ask a question before we close.

Mr. Vertolli, you mentioned herbs that have been restricted. I wonder if you have a list of the products that have been restricted in Canada. Do you know why all of these products have been restricted?

Mr. Michael Vertolli: First of all, I should mention that due to the transitionary nature of what's going on, Health Canada, probably partly as a result of consultations they've had with the advisory panel and other stakeholders, has made some interim changes to the regulatory structure that have taken off some of those restrictions, at least insofar as products being eliminated from the marketplace. We still can't say on the label what they're for and how to use them properly, but at least they're not being taken off the marketplace.

One of the big problems is that nobody ever knew what was restricted. Members of our industry have for years asked people from Health Canada what's restricted and what isn't.

The Chair: Have you been given an answer?

Mr. Michael Vertolli: Never. For years we've been told they can't give us a definitive answer because it changes from day to day. Well, it did change from day to day. That was the problem.

The Chair: Do you have the list now?

Mr. Michael Vertolli: There is no list. There never was a list.

The Chair: Then in terms of the ones that you do know are banned, do you know why they're banned?

Mr. Michael Vertolli: Right now the number of those that are out and out banned is minimal because of the recent changes that have been made to the regulatory structure in lieu of coming regulatory changes.

The Chair: Do you get informed about why they're banned?

Mr. Michael Vertolli: In most cases they were banned based on the things I mentioned earlier. For instance, there's the detection of tiny amounts of substances in them that are toxic when used in isolation.

As well, there are contraindications. If you have a product that is clearly a food and for which Health Canada would not issue a DIN based on what they consider to be health claims acceptable for a natural health product, and if that product was, for instance, contraindicated in pregnancy, their solution would be to take it off the market rather than just put on the label not to use it during pregnancy.

A lot of the information that was presented to you with respect to schedule 705 was inaccurate. You were told that the herbs in schedule 705 were chosen as being not acceptable as foods based on the recommendation of previous expert advisory panels. That's true, but what they did recommend was that the products be allowed for sale in many cases with contraindications. But Health Canada's approach was, no, sorry, we won't accept these as drugs, and they're not acceptable as foods, so therefore we won't allow a contraindication on the label. The product is off the market.

The Chair: Okay. Thank you very much.

Thank you to all of you for appearing today. I think we've all learned a lot.