HEAL Committee Meeting

STANDING COMMITTEE ON HEALTH

COMITÉ PERMANENT DE LA SANTÉ

EVIDENCE

[Recorded by Electronic Apparatus]

Tuesday, February 24, 1998

• 0906

[English]

The Vice-Chair (Ms. Elinor Caplan): The Standing Committee on Health is now in session. I'd like to welcome our first presenters this morning and ask you to introduce yourselves as you begin your presentations.

Welcome.

Mr. Joel Thuna (General Manager, Global Botanical): I am Joel Thuna, from Global Botanical.

Ms. Sandy Thuna (Owner, Global Botanical): I'm Sandy Thuna, from Global Botanical.

[Translation]

Ms. Marie Choquette (Herbalist, L'Armoire aux herbes): Marie Choquette from l'Armoire aux herbes.

Ms. France Lemaire (Director, L'Herbothèque Inc.): France Lemaire, from L'Herbothèque.

[English]

Mr. Ken Keirstead (President, Planta Dei Pharma, Inc.): Ken Keirstead, Planta Dei Pharmaceuticals.

The Vice-Chair (Ms. Elinor Caplan): Have you agreed on how you want to begin your presentation or on who's starting? Okay. Sandy Thuna.

Ms. Sandy Thuna: Joel is doing the presentation.

The Vice-Chair (Ms. Elinor Caplan): Okay, Joel and Sandy, fight it out.

Mr. Joel Thuna: No thanks, there's been enough of that lately.

Voices: Oh, oh.

Mr. Joel Thuna: First, I'd like to say thank you to the committee for allowing us to speak to you today. The most appropriate thing to do would be to explain, first of all, how I come to be here before you.

As you may well know, this whole issue surfaced because there was a public outcry about a year and a half ago, during which our Minister of Health at that time, David Dingwall, received a gargantuan amount of mail prior to the election telling him that the situation could not continue.

What you may not know is the background of how that started. It's a prime example of why this whole problem surfaced.

About two and a half years ago, a small herbal manufacturer, myself, had a shipment seized illegally. It was seized coming into the country by Canada Customs under the orders of Health Canada, and unfortunately, when we pointed out to them that the seizure was illegal, the supervisor or the inspector just said, “Fine. We're still seizing it.” His supervisor backed him up and then the supervisor's supervisor backed the first supervisor up. The only way we had the shipment eventually brought—and legally brought—into the country was by threatening a lawsuit against our own government.

Subsequently we formed an industry alliance that later on became the Canadian Coalition for Health Freedom, which has already made a presentation here.

Unfortunately, that incident shows the hostility of relationships between Health Canada, TPP, the CFIA, whatever they want to call themselves this day, and our industry.

What I'd like to do today is show you what we in the industry have to live with on a daily basis. Hopefully from that you'll get an insight as to why we are very unhappy with the current situation.

First of all, I'll let you know a little about us. I'm the fourth generation of Thunas to be manufacturing herbal products in this country. My family has been doing this for 111 years. We're by no means rookies. I've grown up manufacturing herbal products—throughout my entire life.

• 0910

It is very disheartening and very annoying to have someone who has been studying herbal products for a whole three days come into my warehouse and tell me that in order for me to comply with the legislation in Canada I have to boil the skids that I ship my product out on to meet the safety standards of Canada. We're talking of six feet by six feet long, twelve-inch high skids. I have to boil them. That's what my GMP inspector told me I had to do. This is after investing well in excess of $500,000 in a production facility. He came out and told me this was my fault at that GMP inspection. At this point we told him that if he could find us a vessel large enough we would consider it. It made us very angry and at that point in time we threw up our hands and kicked him out of our building.

That shows you just how asinine—that's the only word I can think of—is the way the regulations are enforced against our industry. That's how I'm starting this.

You'll notice this stack of books in front of me. The only reason it's in front of me is because I couldn't pile it up here, they wouldn't let me. Have no fear, this is not a brief for you read at your leisure. But you should note that I have to know those down pat. Those are the regulations, and those are not a complete set, only part. That's what I could fit in my suitcase. I have to live with these on a daily basis. I have to know those in order to manufacture my products legally in this country. If you multiply that by about two and a half, it's everything we have to know.

For a company employing about twelve people, that is a ridiculously high amount of regulation. That's just insane. We're one of the larger firms in our industry. When you find a firm out there that has three people, they can't afford the time to even flip through it once; forget about actually understanding it, reading it, etc.

Another big problem we have to deal with is inconsistency. We have some problems with Health Canada and the fact that they will allow products in one jurisdiction and won't allow them in another. For the firms that manufacture and distribute across the country, the joke is that if you can't get it through Ontario, you bring it in through Vancouver because the inspectors in Vancouver are a little softer in their enforcement than the inspectors in Ontario. I was always under the impression that all of us are equal under the eyes of the law in this country. I'm not saying I want everything to be the way it is in Vancouver, I'm just saying I would like to see an across-the-board enforcement.

On top of that we have a problem—and this was exhibited most evidently by the herb called hawthorn—whereby a gentleman by the name of Dann Michols, who I know you have had as a witness here, who is the head of TPP, informed me in writing that hawthorn was a food and would have no restrictions on it in this country. The same day, hawthorn was seized by an inspector at the border in Ontario under the guise that it was a drug and would not be allowed entry into this country because no DIN was available for hawthorn. That was the same day. That product was later destroyed. I believe there is a law that you can destroy anything in the name of the crown.

We also have problems whereby the name of a product will cause it to be a drug—just the name. For example, there's a product on the market called Lose-It. It's a three-ingredient product. There are no claims on the label, there's nothing. Legally, according to Health Canada, it is a drug. The exact same product is sold under a different name and it is not a drug.

I'll present to you two bottles, which I will pass around. Inside these bottles is the exact same product. They were actually taken off the exact same assembly line. The one in my right hand is a food. The one in my left hand is a drug. These are both completely legal packages in Canada. Something is wrong when the same product is a food and a drug at the same time. The same product is in capsicum, the exact same physical product. They were probably made on the same day in the same hour.

We also have a situation in Canada where there are many products, such as melatonin—with which I'm sure some of you are familiar—that are considered drugs in this country and are illegal for sale. Yet you can legally import them as a consumer; you can bring in a three-month supply.

My question for Health Canada, which has never been answered, is if the product is harmful, how is it harmful only when I manufacture it but it's not harmful to ingest? The big sticking point I have with this is that our companies in Canada are losing a lot of money and a lot of jobs because while people go to the United States and mail order firms to buy melatonin and bring it into this country, they're also buying legal product to reduce their shipping costs.

• 0915

Just so you understand the depth of the problem, there is one company in the United States that has made it quite publicly known that they have 20,000 regular purchasers from Canada. That is a significant number to an industry our size.

Mr. Joseph Volpe (Eglinton—Lawrence, Lib.): What's the name of that company?

Mr. Joel Thuna: It's called the Life Extension Foundation.

Mr. Joseph Volpe: Thanks.

Mr. Joel Thuna: The other interesting part about inconsistency of regulation is that according to the Government of Canada's TPP, homeopathic products must have a DIN. This is despite the fact that TPP has stated publicly that at best homeopathic products are benign. They're saying on one hand that it's a drug, it has to be regulated, it's harmful; and on the other hand they're saying, well, at best it does nothing. There's a huge gap there.

The other big problem—and this is one I actually brought another example for—is the enforcement of unwritten rules. There is a rule that is unwritten, and has been enforced with a vigour by TPP, that herbs are not allowed for sale for children. There's no expert testimony on why. There has never been any paper put out for discussion. The way they have done it is they've said you can't use the words “child”, “children's”, “for children”, or put a child's dose on any product.

What I have in front of you is a product called Honey Blend. It's a DINed cough syrup. I'll tell you right now: it was designed for children, and it's safe for children. When I applied for a DIN for it for children, I was told absolutely and emphatically that no herbs are allowed for kids. That was their only objection.

If dextromethorphan and all those other words that are about that long—that I can't pronounce or spell for my life and are made from chemicals that I'd never want to see—are safe for kids, how the heck can something that's been used for thousands of years and is used today for children by concerned parents not be safe for children? If you'd like, again, you can take a look at this and see the ingredients.

The other problem is the lack of comprehension of the holistic model. When you have people in TPP, and primarily in the CFIA, and all they know is drugs and all they know is biology and chemistry, and they admit that all they have to have is a B.Sc. in one of those to be there, they just don't understand the fundamental model of how these products work, how they help the body, etc., you're never going to get a fair shake from them. That's not a knock against them. It's just that you can't take someone who's learned one thing their entire lives and just say, okay, forget that, go over here. It's just not going to happen. It doesn't work.

We also have a big problem with the economic impact of all these regulations. If you look in front of me, there's a heck of a large significant economic impact in the fact that we have to pay someone to read all these, figure out how to do it, and keep abreast of it. We devoted people to this.

On top of that, we have the three phases of cost recovery—phases one, two and three—which are exorbitant when combined together. On top of that, we have a DIN process, where the money involved is completely and utterly ridiculous, and we have GMP.

Those combined three things—not only the general cost involved, but the background costs, the costs that you don't figure when these rules are written, the fact that we have to pay someone to actually apply for all these DINs, to do all the research.... It costs us on average $500 to $700 per DIN just to get all the ducks lined up in a row, etc., for the paperwork.

On top of that, to have appropriate pharmaceutical GMP, we have in our building two filing cabinets, and all they do is keep the records for GMP. That is a heck of a lot of money and a heck of a lot of labour, most of it wasted.

I don't know about you guys, but I do believe it is completely and utterly silly for me to have two people inspect that the floor is clean, who swept it, when, and why. That's a little nuts. All you do is look down. “The floor is clean. Okay, we're done.” I don't have to keep paperwork on it for 30 years. It's ridiculous.

On top of that, we have the actual inspections themselves. Because these people have no knowledge of the products or the processes or the way they work, we have to take them through as though we're giving a tour to someone who's a child standing in awe of what's around them.

For example, we make extracts in our building. That's what we do primarily as a company. We had a gentleman who was our inspector, who told us before inspection that he was going to do a really good inspection—he'd been reading about herbs for three days. We were quite impressed by that—not really. Then he proceeded to walk into our warehouse and to ask us “How do you make an extract?” We assumed he was just asking how we did it to see whether we conformed to GMP. No, he didn't know how to make one. We actually stood there and showed him step by step.

• 0920

It got to the point where—this is asinine—he actually asked us how we folded a filter for filtering. The gentleman had obviously never made coffee in his life. We actually had to go up on our shelf, pull down a filter, fold it, and put it in the sieve. It was completely and utterly ridiculous, but the gentleman wielded a power whereby you had no choice but to placate him.

You also get really stupid questions that take hours and hours. A GMP inspection of a 20,000-square-foot building, in our case, took seven hours and the time of three people. That's an expense. Pretty much everything has to slow down to a stop because people wonder what the heck this guy is doing. It's a large cost.

On top of that, they enforce rules that are ridiculous. In schedule 624 of the Food and Drugs Act, under GMP and site licensing, you need to have every ingredient that goes into a drug. You have to be able to state its potency, purity, and active constituents.

Say we make an extract and there's steam-distilled water in it. I have on my written report for GMP that he would like to know, before I'm allowed to get my GMP certificate, the potency and purity of my steam-distilled water. If anyone here or any scientist can tell me that, I'd really appreciate it. It doesn't exist; there is no potency to water. It's an impossibility. It's water. It's either pure or it isn't. That's it.

We also have the problem with DINs in the system itself, with the fact that in order to make claims or put contraindications on a label, the product must have a DIN number, with a couple of exclusions. There are a couple of exclusions where that isn't the case.

Most products do have appropriate contraindications. That is something for public safety. We'd love to be able to put them on our labels. Unfortunately, if we do that, we are breaking the law as it sits right now. Most firms ignore that and do break the law, but it would be nice to know that I don't have to.

On top of that, you also have situations whereby Health Canada, TPP, or whatever, will recognize a claim for a product that is wholly and utterly inappropriate.

Take, for example, St. John's wort. I'm sure that practically everyone here has heard and read about St. John's wort. It has been the darling of the media for the past year. Everyone on the planet knows what St. John's wort is used for. It has been clinically shown to be effective in mild to moderate depression. Unfortunately, in order to sell St. John's wort in Canada, you have to say that it's a traditional herbal medicine for use as a mild sedative.

Something's wrong there. You shouldn't have to lie on your label. You know that no one is going to buy this as a mild sedative. That's not what's going to happen. We should be allowed maybe not to say that it's used for moderate to mild depression, depending on how the law is written, but at least to be able to give proper instructions and contraindications for what it's actually going to be used for.

Another example is chamomile. I have the labelling standard from Health Canada sitting on top there. Chamomile is primarily used in tea or liquid form as a mild relaxant; Health Canada recognizes it only as a digestive aid. I've never seen anyone use it for that, and I've never heard of anyone actually using chamomile as a digestive aid in all the years that I've been in this industry. There are a heck of a lot of better things to use that for.

In some cases, where you have a herb—I'll speak only about herbs, because that's what I know best—you can actually back up, in documentation, from the references listed by Health Canada, an appropriate DIN application. They will deny it flatly if they don't want that product out there.

A perfect example is taheebo, otherwise known as Pau D'Arco or Lapacho. We applied for a DIN for it to be used as an anti-fungal. We had the appropriate documentation. Our DIN application was returned to us, after the fee, informing us that Pau D'Arco was not going to be issued a DIN.

That's it, flat, done. There's no appeal process. That's it. Once Health Canada says something, you might as well write it in the Bible, because that's it. I can't appeal to a higher power. If Dann Michols says no after everyone else has said no, live with it.

That's ridiculous. I thought we lived in a democracy. The biggest complaint that everyone has with the system as it sits now, including citizens' groups, industry, and any other stakeholders, is the fact that the public isn't being served.

• 0925

You're going to be given one of these little packets. This is a product called senna leaves, cut and sifted, and I'll just finish with this one point.

You have had people come before you lately saying that one option you can choose to recommend is that herbs and natural health products not be classified as drugs, that they not be classified as anything else but food. I'm wholly and utterly against that because I think it will be a huge disservice in public safety.

If you look at this product, senna, you may not know what it's about. Have any of you heard of the product called Senokot? It's a laxative, and this is what it's made of. This is a laxative. It's mild and relatively safe. At the same time, you have oat bran as a laxative. Oat bran I consider a food. I will sit down at breakfast and have a bowl of bran flakes. I have in the past, and still will challenge anyone to sit down and have a nice, heaping bowl of senna leaves.

This is not a food. It will never be taken as a food. It would be a huge disservice to public safety to create a category in which this would be a food, because as soon as it's a food, people do not give it the same credence. They won't use it with the same care that they will something that is a natural health product.

I thank you.

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

We have until 10.30 a.m., and you're sharing the time for your presentations. We will then ask questions at the end. How much time you leave will decide how much time there is for discussion.

The next speaker is Ken Keirstead.

Mr. Ken Keirstead: Madam Chair, ladies and gentlemen, it's a pleasure to be visiting Ottawa from New Brunswick. Planta Dei is situated in the St. John River area. We are a private New Brunswick company in pharmaceuticals, and as a clinical biochemist company, our position is a little bit different from that presented. I guess that's why there's a balance in the people that are presenting.

Our company is based very strongly in research and science, in pharmacognosy or phytomedicine. We function with a very strong medical advisory committee and scientific advisory committee in pharmacology, toxicology and pharmacokinetics, and in pharmacognosy itself, which is the study of plant medicine.

Our approach to this industry and to the issues is that the products we are talking about should not be alternative or considered complementary, they should be considered as integrated into the mainstream of medicine, as they are in most European countries. They're not considered outriders, they are part of the system. As you know, in fact, 80% of the world does very well with only phytopharmaceutical products. Whether they are classified as food or drugs, they are not privy to the numbers of synthetic drugs and prescription products that we have in North America and in parts of Europe.

We believe that integrated medicine using these products can be extremely effective for chronic disease and for minor medical systems. That is where they have proven their strength through time immemorial. As our esteemed colleague was mentioning, they have been used for thousands of years, so the precedent has already been set.

We believe proper control and use of these products will bring us cost reduction to our health care system through self-choice, something already happening whether we endorse it not. The consumer is driving this marketplace, not the industry or government. Physician endorsement will take place if adequate good information is available to physicians. In our trips around North America, we have not found one physician who is adverse to good information. They are adverse to no information, and rightly so.

We also believe the lower side-effect profile of these products will give us products that are safe and effective, and will provide far less interventional care because of the side effects of a lot of the prescription products. I'm not damning prescription products, but they are for acute therapy and are very good for it. However, in order for us to move this market forward, we must conform to very strong quality control and quality assurance programs in order to secure the products and the viability of those products.

My second point is a question: Where is the value “for consumers”? How can we bring value as an industry group, as government, or whatever our stakeholder position is?

• 0930

The assumption we would like to bring before you this morning is that if a product is physiologically active enough to be of effect, if it actually does something, it therefore can, theoretically, have side effects or synergistic effects with prescription medicines, and indeed it does. We have reported cases of events that have occurred with so-called safe natural medicines. We report those to the Health Protection Branch. A lot of them go unreported. They do require interventional medical care.

Peanut butter can kill a child if they have a sensitivity to peanut butter. So when we say that all products are benign because they're food, or because they're natural, that is absolutely misinformation.

My question to this panel is, how much or how little do know about this, and how important is it if we are to produce standards and regulations or control?

My second point is that consumers should not be exposed to taking products that are adulterated, mislabelled or inert. By adulterated, I mean products that have come into North America and been spiked with synthetic drugs. That is not my assumption. That is absolute fact.

We inspect less than 5% of the shipments coming into this country in terms of the content of the raw material, even what it actually is. There's a huge problem with the mislabelling of products that come into this country.

We reject, as a company, 50% of all shipments of raw material, whether they come from reputable European companies, oriental companies, or Latin America. There are many cases of this.

We also know many products are volatile. The active ingredient in the herb does not stay as an active ingredient over time, under heat conditions or under light conditions. How much do we know about what we are selling?

My third assumption is that product information currently on the market is often biased and misleading, and often with false or unproven claims. We believe this is a disservice to the consumer. It does not add value and it is not something we, as an industry, should be tolerating.

My last point on the value for consumers is that well-documented products will be supported by professionals and will result in more holistic and balanced therapy. That is the direction in which I would hope we are heading in this huge segment that, at this point in time, I personally would describe as being very wild, uncontrolled and absolutely confusing.

If you've been a consumer trying to buy echinacea, valerian, or St. John's wort, I challenge you to walk the aisles of a drugstore and tell me why you made a choice. The standardization is different and the dosage information is different. There is nothing that tells a consumer why they should buy a product, other than anecdotal or published information in journals and publications that often simply trash Health Canada, the government and regulations, putting them forward as villains.

I would like to comment on the precedent of quality in health care. Health care is a quality industry, and it should be. We're treating disease, whether it's chronic or acute. I don't know of any precedent in good health care that does not imply standards, safety or practice guidelines, or responsibility, more importantly, for the client, the patient. I don't know of any other.

We control radiology. We control drugs. We control clinical therapy. Physicians cannot simply practise and do anything they wish to do. There are clinical practice guidelines. They have to learn something in order to do their activities.

This megatrend we have in North America—and it is a megatrend that will continue, regardless of how we try to capture it or not capture it—will revolutionize cost distribution in health care. It will. It has in Germany. In 1980 Germany did $200 million in phytopharmaceuticals. Today it's $2 billion.

Over 60% of physicians recommend and prescribe phytopharmaceuticals, or plant-derived medicines, before they prescribe a synthetic drug. It will change the role of physicians in chronic disease.

We are into gene mapping, or genome research, right now, which looks at the 80,000 genes that make up our body. Deficiencies in those genes will lead us to supplement the diet, the food, and the herbal replacements, whatever those are, to treat chronic disease and strengthen either the cardiac system or the immune system, whatever the system is, over a period of time.

We will also dramatically alter wellness programs, wellness being, I hope, the objective of every stakeholder in this discussion today.

• 0935

An example I'd like to touch on very briefly is St. John's wort, which our member also talked about. It is outselling Prozac in Europe by anywhere from 5:1 to 10:1. Prozac is the highest-prescribed drug for—and I mean this with a certain amount of humour—our civil servants in Canada.

I bring you the example of Nyrine, which is a sedative made of valerian and other areas. It is outselling Valium. Valium is addictive; valerian is not. Why aren't we using it?

Saw palmetto, which is used as opposed to Proscar for prostate therapy, is proven in scientific papers to be maybe as effective, if not as effective. It's certainly a very safe and inexpensive way to treat a disease that is affecting more and more senior people.

What is needed in this industry? In our opinion, raw material validation is extremely important. We need certificates of analysis. We would beg that the government, Revenue Canada, and Customs and Excise have standards, and standards that are enforced, on raw material imported into this country so it is not mislabelled or adulterated.

We need good products. We need the identity of the plant species. Pulverized plant material looks like pulverized plant material. You don't have a clue what you're looking at unless you do a footprint analysis on that product. We need verification of active ingredient. Is there any and should there be?

We need standard monographs. Health Canada, Mr. Michol's department, is working toward standardized monographs. We have German Commission E now. We have many precedents that should be used as standard monographs and adopted. They aren't yet.

We need certified facilities to manufacture these products. We need approved labelling with precautions, precautions that are allowed by Health Canada under a full understanding of what these products do. We need audit and responsible enforcement to raise standards. This is not taking place. Lastly, we need safe and intelligent products, labels, and regulations in order for this segment to grow to where we believe it ought to go.

Thank you very much.

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

Marie.

[Translation]

Ms. Marie Choquette: I represent L'Armoire aux herbes, a traditional botanical small business situated in the Bois-Francs region in the village of Ham-Nord, Quebec. In our traditional business we grow our herbs from seed to seed, we harvest our plants ourselves, and we process them as well.

We are first and foremost an agricultural business, that is we are fully aware of the cycle of the plant from the time it is planted in the soil until it is ready for processing. We consider that it is important to recognize the various stages of the plant's development. For us the plant is truly a living organism.

As herbalists who believe in living matter, we also have a vocation concerning the use of the soil. We have a Demeter certification, something that is recognized worldwide, that is in at least 45 countries. This certification must be renewed every year. We have been certified for eight years. The Demeter certification is a recognition of the fact that we take care of our plants and our products as well as the soil. This vocation is extremely important for us.

We not only seek to produce therapeutic plants but also to ensure that the plants we use are those that we produce, that we grow ourselves.

L'Armoire aux herbes has a very regional distribution network. We have about 250 sales outlets in Quebec and New Brunswick. We function on a human scale. We do not attempt to create needs, we simply respond to existing needs.

• 0940

We have a very varied production. We have a great many plants but not necessarily in large quantities. Our foremost concern is the quality of the product. Our clients are looking for this quality and this respect for the earth, for nature and plants.

The traditional herbalist uses living matter to treat living creatures. Our expertise and our reputation are already recognized not only in Quebec but in some other countries. We offer many guided visits of our gardens and we receive several delegations from countries in Europe, South America and Africa. These are people who have come to see us and have taken us as a model for their own dispensaries.

It would be very unfortunate if Canada did not recognize its own assets. As a traditional botanical business, we have a very thorough knowledge of our plants, their properties and their clinical effects on people using our products but that does not mean that we have a large number of academic qualifications. Our knowledge has been transmitted to us over the ages by the men and women in possession of such knowledge and who continue to treat people throughout the world.

We work very closely with people and we have a true knowledge of our material, our plants.

Of course we've had a great deal of difficulty with the Food and Drugs Act as you can imagine. Are our products considered to be food or to be drugs? Are rosemary and thyme simply herbs used in cooking or are they therapeutic? We had a great deal of problems with labelling, among other things. Whenever an official came to see what we were doing, he would make us change our label.

It is obvious that for a small business with 6 to 12 employees and a total business volume of $300,000 to $400,000 a year, changing labels is a costly proposition. It is also something that distracts us from our main focus, mainly devoting our energy to our plants and to people's health. With a constant need to replace our labels... Besides, it's completely arbitrary. Two or three years later, there was another official who, under this same schedule A of the Food and Drugs Act, decided that we would have to do something different and made us change once again the names of our products. It doesn't make any sense to us. Sometimes we would be forbidden to sell certain plants and not understand why.

There are some plants that have been in use for thousands of years. The scientists have decided that they're dangerous but we do not share their opinion. It isn't logical. For thousands of years these plants have been used for treating humans and suddenly we are expected to believe that they have become dangerous.

We are asking the government first and foremost to take an overall approach in settling this natural products issue. It is very important because we don't want officials, whenever they make a visit, coming up with yet another new interpretation of the Food and Drugs Act or of the Good Manufacturing Practices manual. That is very important for us.

We also want the decisions at this level to take into account traditional herbal medicine. For us it is very very important. Our very survival is at stake.

We would also like to see the creation of a Canadian pharmacopeia. But that is not something that can be done in a few months. We must take the amount of time required to do the job and also to ensure that application is consistent.

Of course, we would want to see the involvement not only of scientists but also traditional herbalists. In Quebec we have la Guilde des herboristes. This is an association of people who have knowledge of plants. Our guild could suggest to you the names of individuals who could be members of a committee.

• 0945

Our solution would be to have a third category for natural products. In other words, there would be food, drugs and a third category with room for medicinal plants. They would be defined in a different manner. As we see it, natural products cover a fairly wide field. Vitamins and minerals are not something we grow in our fields, what we grow are plants.

There is something I have to say about plants. Plants are not merely active principles or chemical formulas. They are something living. I believe that we have not yet fully discovered all the properties of living plants. For us this living quality is very important. As the gentleman from New Brunswick noted, very often when we import products, there is not much life left in our plants.

Notions about quality and safety standards are also very important but we have to realize that there are plants that have been in use for thousands of years. That is something that must be taken into account.

We are also asking for a more flexible Schedule A concerning labelling. It is very important for us to be able to indicate on our product labels their use and the proper dosage for them to be efficient and safe. That is a very serious deficiency. If the Act wishes to protect the consumer, then it must do so. At the present time, it's just the opposite. People buy the products and since there's nothing written on them or indications are very vague, there's a chance that people may do themselves more harm then good.

We also want to be recognized as traditional herbalists. We want our traditional knowledge to be recognized and to have the right to inform people about the properties of plants; we want official recognition.

We also have some requests to make about Good Manufacturing Practices. We were visited by Health Canada but it had nothing to do with us. We are a small business. Our plants are grown in our gardens and then taken to a building that is not very large, but it's clean and properly organized. We keep note of our data but it's more of a kitchen than a lab. We are not pharmacologists. We are not lab assistants. If you saw our business, you would understand that there is absolutely no comparison.

So it is very important for us that Good Manufacturing Practices be adapted to traditional herbalism and not an incentive to close down our businesses. In any case, if we are required to make such investments, we'll have no choice but to shut down; what is the idea behind that? It's very important for us.

We also want official recognition of traditional botanical small businesses. We want a clear status for medicinal herbs. Yes, medicinal herbs are curative. Let's not play cat and mouse games. Yes, they are curative. We're also asking for traditional herbalists to have the right to say something about this, not only doctors writing prescriptions. For us this is very important. At the present time, traditional herbalists are far more qualified to talk about medicinal plants than any scientific specialist.

Another important thing is quality control as opposed to standardization. We are in favour of quality control but we need better resources and better adapted tools than those we have at the present time.

• 0950

We are talking about living matter. In this room there are no two people with eyes and hair of the same colour. You all have a different genetic heritage. If you were standardized, you would all be the same size, you would have the same colour of hair and so forth. That is not how things are.

Yes, we want quality control but we don't want everything to be the same. We can't understand that. There is no logic to it in our view. It is the strength of the plants' vitality that we are looking for.

Yes, there must be active principles but we do not have an exact knowledge of everything there is in plants. We haven't discovered everything. That is something that the traditional herbalist understands. The scientific world will have to open up to this way of seeing things.

We also want official recognition of the curative property of herbs. We want their sale to remain unrestricted. That is also something very important for us. We want unrestricted sale to continue and we want treatment by herbs to be considered not only a science but as a true art, the use of living material to maintain life.

The herbalist is a bridge between the plant world and humans. The knowledge of herbalists is a living heritage. For thousands of years men and women have been passing on this tradition. We are perpetuating it and it will continue into the third millennium somehow or another.

In the Middle Ages there were witch hunts and people were burned at the stake. Today we do not want to be burned on the stake of costly licenses and laws that are so oppressive that the whole business will go up in smoke. Do you understand?

An Honourable Member: Witches.

Ms. Marie Choquette: Yes. We don't want to be taken for witches. We refuse the industrial and lab definition of good manufacturing practices. We want good manufacturing practices that are adapted to our circumstances. We are not a copy of pharmaceutical companies. We are not attempting to achieve the same kind of overwhelming visibility and their huge profits. We are at the service of the plant and human world.

We also want to be able to broadcast the traditional effects of plants. We want to have the right to say so officially. We don't want to have to hide in order to speak about this.

We also want a standing committee on medicinal plants made up of experts from both traditional and scientific backgrounds without one being more important than the other. To identify experts from the traditional background, associations such as the Guilde des herboristes in Quebec and other regional herbalist associations should be contacted.

We also want a clear list of dangerous plants to be established by this committee of experts. What we want, really, is simply asking to occupy our proper place.

We would like the government of Canada to take a look at practices elsewhere, but since we know that Canada is a young and innovative country, we want Canada to be able to innovate and come up with tools adapted to our times.

We want the consumer to be able to make his choice of therapy. We are intelligent enough as consumers to be able to make our own choices, especially if information is openly and clearly disseminated.

I would like to conclude by thanking you for giving me this chance to express myself freely today. As a small herbal business, we cannot afford to pay for a lobbyist.

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

[English]

Thank you.

Our last speaker is France Lemaire.

[Translation]

Ms. France Lemaire: Good morning. I represent L'Herbothèque, a publishing company. We are specialized in popular works on all kinds of medical subjects, but more particularly with respect to herbs. But first and foremost, L'Herbothèque is a school for the training of herbalists. We have approximately 300 students being trained as herbalists at different levels. We offer different types of training.

• 0955

Our main purpose in coming today is to speak on behalf of our students, these people we are training and to whom we are passing on our knowledge of the tradition of herbs. They are the future herbalists who will be producing plants, who will be growing plants.

As we see the practise of herbalism, similar to Marie's explanation, a herbalist is mainly a person who grows his herbs. The herb trade is a traditional art, a regional one, it is local.

At one time, every small village had its own herbalist. All countries recognized herbalists. Their knowledge and their skills were recognized. It is very, very regional. It is always something done on a very small scale because it deals with living matter, the things that surround us, the plants that grow in our vicinity. Customers also come from the region.

At the present time, we have 300 people receiving training and their numbers will be increasing because it is becoming clearer and clearer to people that we have everything we need around us to treat a great many of our complaints and daily problems.

These students are future herbalists, people who will be growing, recommending and making products. They will eventually have their own stores and offer their products for sale. They are wondering where they are heading and what they will have the right to make, sell and say. It is on behalf of these students and future students that we have come to speak to you.

We are not appearing as producers but rather on this matter of information. From what I understood in English, there will of course be the plants and we are limited in terms of information but there are also companies that have a more pharmaceutical vision of the way the product can be processed for the market. That is something you must take into account and it is very important.

It is in this respect that the Act must be made more flexible. I do not think that we can stifle the traditional art of herbalism. Whenever we are included under health products, there will always be a distinction because that is not our reality. It is very important for us to have this recognized.

Yes, plants are medicinal. All of them. Basil is medicinal as well as garlic. Any plant is medicinal. The essential thing is to know whether they are toxic and at what level. This is something that herbalists can tell you. Herbalists do not work with active principles.

As the gentleman pointed out, there are all sorts of synthetic drugs on the market and heaven knows that they have many side effects and can create addiction which is not necessarily the case for herbs. That isn't how herbs work. Herbs are at the root of many synthetic products but they are in a separate category.

We are asking the government to take the time to review the status of herbs, the famous status manual which is in fact a collection of prohibitions. That isn't what we want. Yes, they are all medicinal. So consider them as such and determine at what level they are medicinal and what can be said about them.

Pharmacopeias are already in existence. We can make use of them since there is no need to reinvent the wheel. There is a real world around us here in Canada and North America. What products can we use that are not and will not be classified as drugs? What can be allowed?

We have them on the ground. You can't prevent them from growing. They are there. Furthermore, herbalists work to ensure the survival of species. The notion of respect is important. Marie made reference to this and I think that everyone agrees. Herbalism is broader, far more inclusive. We also are concerned with education because we work with other associations and organizations for the survival of certain species.

In teaching herbalists, we deal with the herbs that grow here. I am talking mainly about Quebec since this is the place and the reality I am familiar with. We train people here and we teach them to work with the plants that grow here. We don't work with other plants. We talk about what grows here because it's more accessible but at the same time we do not teach about the use of certain plants whose survival would be threatened if they were harvested on a large scale. It is a matter of respect and reflects a holistic approach.

• 1000

The medicine use of herbs, like many types of medicine referred to as alternative or alternative therapies, focusses on prevention. That is recognized and should give us pause in our overall consideration of health and hospitals as opposed to home care. All of this comes into play given the emphasis on prevention by all alternative medicines.

It is true that a great many things are taking place and we are perfectly willing to admit this. Any company involved in processing has its own standards and rules and must show integrity in its practices; otherwise, it would not be on the market.

But some flexibility is required. Each company should be able to negotiate with the inspector, depending on its scale of operations. I realize that inspectors are not able to know everything but when they arrive at a company, they do not know what to expect.

I was present during an inspection of L'Armoire aux herbes and heaven knows that the person doing the inspection knew nothing at all about what we were doing. He didn't have a clue. He didn't even know what kind of company he was coming to inspect. He expected to find boxes of plants. I said, no, the plants are outside in the garden. Then that became a problem. What were we doing with them?

There are all sorts of criteria that we have no reason to assess as herbalists. The majority of botanical companies, as many as 99%, work with organic products. This does away with all sorts of harmful aspects, and control aspects. That shows you the extent to which the respect for the quality of what we offer is important for us as herbalists.

So you have to take a look at plant monographs to be able to say that they are in fact medicinal. How medicinal? What is their toxicity? Are they toxic? In such a case, those that are toxic may be classified differently. But the plants remain medicinal herbs.

If we set up a committee of experts or a study committee, I don't know how it would be described, it must represent the entire manufacturing and therapeutic reality. We do indeed have different visions and we must come to a common understanding. Experienced herbalists who practice in the field must be present, contrary to present practice.

That is very important. I know that there is an attempt being made to centralize but we have to be realistic. Our reality in this part of Canada and the reality in the West are not the same, if only because of the different kinds of crops. To simplify things then some of the regional aspects must be taken into account in this study.

As Marie said, the Guilde was able to present its brief. Associations have been created and we've been working together, particularly in Quebec. I am telling you this because I am familiar with the reality. Different companies and different herbalists who are actually competitors, are working hand in hand so the Act is modified in keeping with our reality. We are very anxious to have people consulted, people who are really active in this field.

We must give ourselves the time necessary to examine all of this. We have a good opportunity to do so. Of course we have some questions. We wonder what the final results will be. There are piles of documents. You have some and I have a huge quantity. It's a good idea to bring all of this together.

It's awfully tough having to read through all of this because it is not our field, but it is nonetheless necessary. I have a great deal of respect and admiration for the people who are investigating these matters and who drafted these texts because it is by no means easy.

It is my ardent hope, and I am not alone in this respect, that you will take the time necessary to look into these aspects and that things will be made more flexible. We must create something dynamic so that things can start moving more quickly. People always say that a lot of time is necessary to change laws. Yes, it is a long process. For the shorter schedules, things can start moving and that is what we hope.

• 1005

Try to come up with something dynamic. Give us an opportunity to let you know what our experience is. You are to be commended on this initiative. I don't know whether these people are present but I'd like to thank those to whom I spoke, who received our briefs, who explained where the meeting would be held. I received a detailed map. It was very well done and I'd like to thank them for this. I simply hope that the conclusion will be just as promising.

[English]

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

We have approximately 15 or 20 minutes left for questioning. Then I will adjourn the committee to give us a five-minute break before the next presentation begins.

Dr. Hill, five minutes.

Mr. Grant Hill (Macleod, Ref.): Thank you, one and all, for your presentation here.

Mr. Keirstead, you mentioned a tremendous change in procedures in Germany. Would you recognize that most of the natural products in Germany are supplied by fairly large companies, which have been moving more towards a pharmaceutical component to their activities?

Mr. Ken Keirstead: It's a combination of large companies.... There are about 85 suppliers, of which probably two-thirds are fairly small.

Most are now provided by prescription. They are difficult to obtain by recommendation, not by prescription; that's accurate.

Mr. Grant Hill: To the others here, the Thunas in particular, what would a far more strict routine do to your business? Mr. Keirstead did suggest some fairly strict new rules and regulations. What would those do to your business?

Mr. Joel Thuna: The majority of the regulations he is talking about I would have absolutely no problem with. One I would have severe problems with is looking for active constituents, or standardization. The plain problem with that is I don't know of one herb out there in the mainstream that we know enough about, where I would be willing to say, okay, if it has 3% of this, it's pharmacologically active, it's perfect, it's beautiful.

One of the herbs we know the most about is feverfew. Canada spent millions of dollars learning about feverfew, through a gentleman by the name of Dennis Awang, who admits openly we still can't say that about feverfew.

The standard out there right now is that we get 0.2% parthenolide. The problem is if you sell a product that's 0.2% parthenolide and not the rest of feverfew—just 0.2% parthenolide in a product—it's completely and utterly useless. But we know feverfew with 0.2% parthenolide works.

Clearly we don't know enough to go that far.

But the rest of what the gentleman is saying I don't really have much of a problem with. We do need quality. We do need to have our raw materials inspected. I do think standardization is definitely the wrong way to go, right now and in the near future, until we know enough to say definitely “This is perfect”.

[Translation]

Mr. Grant Hill: Ms. Choquette, if we adopt stricter regulations for your business, will it cause you problems in the future?

Ms. Marie Choquette: If the regulations are stricter, we will no longer have an official existence. But, as France said, our gardens will continue to grow. We cannot meet the present standards because they have no relationship with medicinal plants and an agricultural operation.

We are first and foremost an agricultural operation. We process our products. We respect the standards of the Quebec Department of Agriculture but have no dealings with large pharmaceutical and industrial companies.

We have lots of plants. We have more than 100 plants that we process on a small scale. We do not have large quantities of plants. We would not be able to afford this. We don't have the business volume necessary. Our annual business volume would not even be able to pay for our entire selection of plants. But we are not willing to cut back on the number because we think there is a demand for all these plants.

We exist because of the demand. We are the result of this demand. Our company keeps up with the growth in the demand of the population living around us. People believe in the quality of our products. We do not do any advertising to make our plants known. They are plants that grow in the region. We are familiar with their properties and people want them. That is why we have a large selection. We are not trying to create a need.

• 1010

Mr. Grant Hill: Mr. Keirstead said that Germany was the best country in this field. What about other countries?

Ms. Marie Choquette: Germany?

Ms. France Lemaire: I wouldn't say that Germany is the best country in our field, at least judging from what I have read and what I've been told.

I don't know how to say “recommendation”, in French, but between a prescription and a recommendation... If you want to go and buy a herbal product or vitamin C, and it's behind a counter and the person asks for it... I read an article on the Internet in which a person told of her experience in Germany, where the vitamin C was kept behind a counter. She asked, “I'd like some vitamin C” and she was asked, “What strength would you like?” “I would like such and such a strength.” “And why do you want it?” She had to insist to get some vitamin C. And I'm not talking about an herbal product. The person just wanted ordinary vitamin C that you can buy anywhere.

I don't know the names of the pharmacies here, but at Jean Coutu, it's quite customary. Everyone buys vitamin C. I've never seen a bottle of vitamin C that says if you take too much you may get diarrhea. It may not necessarily be a good idea, particularly in the case of traditional herbalists such as L'Armoire aux herbes.

As I was saying earlier, plants are medicinal. You will have to be consistent when you do your study, because many, many plants are medicinal. They are not toxic, but they are medicinal. What's the difference between basil and...? Does anyone know what basil is used for here? Or there's chamomile. Ever since we were little children, we were told, “If you want a good night's sleep, make yourself some chamomile tea.”

Mr. Grant Hill: What country is the best these days?

[English]

The Vice-Chair (Ms. Elinor Caplan): Dr. Hill, your time is up. Thank you very much.

Mr. Myers.

Mr. Lynn Myers (Waterloo—Wellington, Lib.): I have three quick questions to Mr. Keirstead. You spoke of A being harmful and about there being misinformation about C and such. Do you actually have examples of that?

Mr. Ken Keirstead: There have been several studies done. Let me cite one in the U.S. where 50% of 600 different packagings of Siberian ginseng or ginseng was proven to be mislabelled and didn't contain the ginseng they were supposed to contain.

Mr. Lynn Myers: So you're aware of other studies, but you have not done any yet yourself.

Mr. Ken Keirstead: We have done studies as well.

Mr. Lynn Myers: Could you provide that to the committee? Is that possible?

Mr. Ken Keirstead: We could provide a summary to you, definitely.

Mr. Lynn Myers: What about B, with respect to where these products are coming from? Where is the problem?

Mr. Ken Keirstead: The problem, which was mentioned here a few times, is that a lot of the active ingredients are volatile. I would make an exception only on qualification in terms of the comment that was made that we should not have to standardize. The active ingredient may not be clearly understood, but certainly there is the ability to measure a market compound that alludes to the active ingredient. So if you have nothing of that market compound or the active ingredient in the product, then you know fairly well it's inert.

We have looked at products coming into North America, especially through San Diego where they are spot-checking with the FDA and U.S. customs, and a lot of the products that are coming in are mislabelled and adulterated. That's in a public report. We have that report and could submit it if you so desired.

Mr. Lynn Myers: I think that would be useful as well.

Mr. Thuna, I was interested in your report and your testimony in terms of lack of understanding and inconsistency and the fact that an appeal process doesn't exist, etc. What really has to be done here? Is it an attitudinal change? Is it a regulation change? What in your view should be done? A corollary question is, do you support this third category?

Mr. Joe Thuna: I'll take the second part first. My support is firmly behind the resolution that was put forth by the Canadian Coalition of Herbal Associations. Michael Vertolli presented it to you about two weeks ago and I have read it. I believe if the recommendations within that were adopted, whereby the expert body starts at the top and the expertise funnels through, there wouldn't be one person in our industry or one consumer who was disserved or unhappy.

I believe it must have regional representation, because there are differences in the cultures across this country, not just between Quebec and the west. Particularly also in the east of Newfoundland and in the north there's a significant difference in knowledge base. I believe that if this were adopted it could literally make everyone happy.

• 1015

I don't think an attitudinal change will be enough. The problem is you have people coming from one school of thinking, and I think asking them to change their attitudes, first, would completely unfair to them, and secondly, it would result in a worse situation than we have right now. I think you have to start with people who are educated appropriately and who have belief in the model from day one, and have them involved. I think any change from that would be a disservice to all parties involved, including the regulator itself.

Mr. Lynn Myers: Do I have time for my third question?

The Vice-Chair (Ms. Elinor Caplan): You have about a minute.

Mr. Lynn Myers: My question is for Ms. Lemaire. You're an expert in the educational area and I wondered if you could comment. I know this is provincial jurisdiction in part, but what is being done now; and more to the point, what should be done?

Ms. Marie Choquette: I'm not clear on what you said.

Mr. Lynn Myers: What is being done now from an educational point of view—

Mr. Joel Thuna: For standardization within Quebec and for educational standards.

Ms. Marie Choquette: That's not the point; your question is not clear. It's not because we don't understand the English.

Mr. Lynn Myers: What are you doing as an educator? You have 300 students.

Ms. Marie Choquette: Yes.

Mr. Lynn Myers: And you're presumably educating them in herbalism.

[Translation]

Ms. France Lemaire: Yes, we teach herbalism. We teach our students how to grow the plants, harvest them, use them to make various products, how to use these products and how to explain to people how they should use these plants and products. We teach herbalism itself, and our courses are not just for people who are herbalists and who are able to recommend products, they're for everyone, for consumers too.

We give various kinds of courses so that consumers realize that the basil plants in their garden aren't just for pesto, but also make an excellent tea to calm the nerves. That's what we teach.

[English]

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

The next is Mr. Drouin.

[Translation]

Mr. Claude Drouin (Beauce, Lib.): I would like to welcome you and thank you for your presentations.

Ms. Lemaire, your company is not just a school, it publishes books as well. Where did you gain the knowledge that enables you to provide training to these 300 students?

Ms. France Lemaire: Information about herbalism is passed from person to person. It's a traditional thing. Some people have learned from others who have studied a great deal, who have experimented a great deal, read quite a bit, and so the knowledge is handed down. It is also based on expertise.

The head teacher at our school is Danièle Laberge, who is recognized as one of the rare experienced herbalists in Quebec. She has more than 20 years of experience. She began by studying with herbalists in the United States and with Amerindians. She has gained expertise and is passing it on to others. She has trained everyone who works at L'Armoire aux herbes. She trained me, and she has trained everyone. That is how herbal medicine is taught. There are various stages. The knowledge is handed down, and people also learn from experience.

At L'Armoire aux herbes, people have to wait several years before they can start making herbal products. The person starts by working in the gardens. She doesn't start processing right away. First a number of skills have to be developed. That is the reality of herbal medicine. That's what it's all about. It's not like working in a laboratory. That is what people have to understand, and that is why the GMPs are not appropriate at all. We can't have a laboratory manager, a corporate manager, or a quality control manager. We have five employees. If we have to have all these managers, there won't be any jobs for anyone. People will have to have a university degree, and herbalism isn't about that.

[English]

The Vice-Chair (Ms. Elinor Caplan): Did you want to make a comment on that, Mr. Keirstead?

Mr. Ken Keirstead: Yes, I have a comment to support what is being said. There is a tremendous wealth of knowledge of herbal products and herbal medicines. The NAPRALERT database in the United States lists some 70,000 different sources of information. The Herb Research Foundation will give you copies of clinical publications. For echinacea alone there are 64 medical journal publications that are peer reviewed in international journals: the European databases, the German pharmacopoeia, the British Herbal Compendium. Countless documents are available to us for standardization purposes, and our appeal is that these be recognized as bona fide sources of information, which some of them are. There is a world of knowledge out there.

• 1020

This is not a new science. It's a very old science.

The Vice-Chair (Ms. Elinor Caplan): Mr. Elley.

Mr. Reed Elley (Nanaimo—Cowichan, Ref.): Thank you.

Madame Choquette, you raised something I have not really thought a lot about in our investigation of this subject. Do you think if we went to fairly strict regulation of herbs and herbal remedies a small company like yours would, over time, eventually be squeezed out of the market in Canada and you would find larger companies taking over smaller companies and that would be the end of, say, the small home-based farm business like your own?

[Translation]

Ms. Marie Choquette: We operate on a small scale because we want to stay close to our plants. So a lot of our work is manual. We do not want to become an industrial operation. That is not our goal. Indeed, we could be bought up by the big companies that see a chance to make a lot of money. You mustn't fool yourselves: there are people out there who see a lot of money in herbal medicine these days. That is not our goal at all.

Yes, we do think we could disappear. The plants will not disappear, but our small company could disappear, and that would be a real pity, because small is sometimes beautiful. It creates diversity.

Mr. Reed Elley: Thank you.

[English]

Mr. Joel Thuna: May I make a comment? You should note that according to Health Canada's own person involved...they made a statement when cost recovery phase three was announced, which was schedule 1056, that they conceded there was a good chance that within a couple of years any firm with net sales of under $2 million a year would not survive. Just to put that in perspective, I would personally estimate that's 95% of our industry.

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

The committee will reconvene in a few minutes.

• 1022

• 1037

The Vice-Chair (Ms. Elinor Caplan): I'd like to reconvene the committee. I would ask everyone to take their place. I want to maximize the time for the presenters and for questions. We must adjourn promptly at noon.

Welcome. I'll go according to the list on the agenda of the standing committee. What I'd ask is that you all introduce yourselves for the committee at the start of your presentation. We won't waste time by doing it all at the beginning. This morning I was just ragging the puck a little.

Dr. Lois Hare, please begin.

Dr. Lois M. Hare (Past Chair, Board of Directors, Canadian Naturopathic Association): Actually, in order to clarify our presentation, I think it would be better if Dr. Saunders presented first.

The Vice-Chair (Ms. Elinor Caplan): That's fine.

Dr. Saunders, welcome. Please introduce yourself and begin your presentation.

Dr. Paul R. Saunders (Associate Dean, Naturopathic Medical Affairs, Canadian College of Naturopathic Medicine): Good morning. I would like to extend a thank you to the committee for allowing us to present. My name is Dr. Paul Saunders, and I'm associate dean at the Canadian College of Naturopathic Medicine, as well as chairman of the botanical medicine program at the college. I also have a private practice in Dundas, Ontario, which is near Hamilton.

I'm representing the Canadian College of Naturopathic Medicine this morning. Naturopathic medicine is defined as the art and science of diagnosis, treatment and prevention of disease using natural means. These kinds of natural means are stimulating to the body's inherent immune system and its inherent ability to heal itself. Naturopathic medicine is a system of primary care health practice that is over a hundred years old, and it has now grown to include most of the British protectorates, the United Kingdom, the Netherlands, South Africa, India, Australia, New Zealand, the United States and Canada.

Naturopathic physicians are recognized as the international leaders in complementary health care. They are primary care providers, and they are trained in the use of botanical substances—which have been much before the committee—as well as in the use of nutritional supplements, homeopathic medicines, acupuncture, manipulation and so forth. As a result of their education, they are examined at an international licensing level prior to being able to practise.

The therapies currently used by Canadian naturopathic physicians include acupuncture and oriental medicine, which is traditional diagnosis and treatment using diet, herbs and acupuncture; botanical medicine, which is the use of whole herbs and compounded formulas that are prescribed to the individual symptoms of our patients; clinical nutrition, which consists of dietary analysis and modification and supplementation where needed to prevent or treat disease; homeopathic medicine, which consists of minute doses of plant, animal and mineral substances used to treat and prevent disease...

[Editor's Note: Technical difficulty] ...to promote immunity and healing; naturopathic manipulation, which consists of musculoskeletal adjustments and soft tissue treatments; and then prevention and lifestyle counselling, whereby the patient takes responsibility for their own health care.

• 1040

The Canadian College of Naturopathic Medicine is the only four-year, full-time, approved and recognized college of naturopathic medicine in Canada. There are also naturopathic colleges in the United States, England, South Africa, Australia, New Zealand, and so forth. Our goal is to produce excellence in naturopathic medical education, research and clinical practice.

We are also before the accreditation of the Council on Naturopathic Medical Education of the Department of Education of the United States, which is the only organization that accredits naturopathic education throughout the world.

We provide our graduates 1,500 hours of clinical training and 3,500 academic clock hours. This is a four-year, full-time program that requires three to four years of university pre-medical science before individuals can matriculate at the naturopathic college.

We provide our graduates with an eclectic training in the various therapies I identified. They receive a minimum of 200 to 225 to 250 hours in each of these areas, and this meets and exceeds the minimum standards required by the United Nations in some of these various complementary therapies.

Specialization, then, is available to our graduates after they have graduated, and they may choose to specialize much further in botanical medicine, or homeopathic medicine, or acupuncture, or manipulation.

Our teaching clinic is the largest complementary health care clinic in Canada, and it offers its patients the broadest spectrum of complementary health care using natural therapies.

At the end of second year, our students must take NPLEX, the naturopathic physicians licensing examinations, in order to continue in the program and to continue their clinical training. At the end of the fourth year, they take the clinical portion of the NPLEX examination, which is on the order of about 14 different exams, before they can actually be licensed and practise as a naturopathic physician.

So in naturopathic medicine, competence is equal to training, plus licensing examinations and demonstration of ability at the clinical level.

As I mentioned before, our curriculum is annually reviewed by the Council on Naturopathic Medical Education, which is the Department of Education in the United States. As a result of this, because we take an international examination, our graduates can practise in Canada, they can practise in the United States, and some of them have actually chosen to practise in the United Kingdom. So we've met the standards that allow our graduates to go anywhere.

What's unique about the education is that the college is private. It is a not-for-profit organization supported by student tuition on the order of about $12,500 per year, and students can secure loans and grants through the United States, Canadian and other governments in order to attend. Given current enrolments, we are graduating approximately 125 new naturopathic physicians each year, most of whom stay in Canada.

Naturopathic physicians use natural remedies and substances, and these are prescribed individually for the patient. A patient presents with a particular set of symptoms, and we prescribe that individually. These could include: dietary modifications or nutritional supplements, botanical medicines, homeopathic medicines, vitamins, minerals, amino acids, enzymes, co-enzymes, and co-factors. These can be given to the patient orally, rectally or parenterally—in other words, through intervenous or intermuscular routes of administration.

It's imperative to us that everything we prescribe to our patients be safe, pure and of high quality. We demand that of the products we use, and we expect that to reduce the risk and to enhance the benefit for our patients.

There's a large body of scientific literature to support the benefits of using naturopathic medicine within the individual therapies. It exists in the scientific research that has been published in North America, Europe, England, China, India and elsewhere around the world; there is a large body. It shows what medicines are efficacious and what are not.

At the end of the period of time, then, our graduates are available to practise. But the difficulty is, as the only licensed group of doctors who are able to provide these services in Canada, we are not recognized as practitioners under the current Food and Drugs Act. Consequently our graduates are restricted from prescribing substances under schedules I, II, IV, D, F, and the Controlled Drugs and Substances Act, yet our graduates are the only individuals who have been trained, practised clinically and examined on these substances throughout medical practice in Canada.

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So we feel it is important that we be included as practitioners under the Food and Drugs Act and that we have a right to prescribe these things on which our graduates have been trained and which they may be able to use in other jurisdictions—for example, the United Kingdom, Germany, and the United States.

Schedule A lists a series of diseases that Canadians are not supposed to self-treat, and we certainly understand the role of Health Canada in wanting to protect the public against itself. However, the list of diseases in schedule A is severely out of date. For example, AIDS and hepatitis are not on that list. So it's very difficult to enforce and keep that list up. Frankly, as a naturopathic physician, every day that I practise, I violate the tenets of that list, because I treat patients who have heart disease, cancer, asthma, and so forth, which are on that list of diseases.

So what we're recommending is that the schedule A list of diseases and conditions be done away with, that you allow naturopathic physicians to practise as we have been trained, and that we be included on that list.

Within some of our clinics, we provide a dispensary function to our patients, and that's mainly to provide items that are not readily available. It's generally a fairly small volume of sale. We would like to continue in that vein to be able to provide botanicals, homeopathic and nutritional supplements, and parenteral medicines. This is particularly important, as many of us practise in small areas that are away from urban centres of Canada and do not have these medicines available.

In Europe, which is a good place to look to for a model of the practise of naturopathic medicine, they have what is called a two-tiered system of prescribing. There are substances that are basically safe and available for over-the-counter use, and then substances that have a greater risk of harm or interaction with pharmaceuticals. Our students are trained, before they graduate, in the potential interactions between these substances.

What we propose is that a similar system be adopted in Canada that would allow over-the-counter sales of certain substances that are safe, and then a more restricted category that would be available to practitioners who have the training, skills, examination, and licensing to be able to do that.

Further, we propose that the substances sold over the counter be able to make claims, because they have DINs, such that the public will know when they can take a substance or not take a substance. Unfortunately that's not allowed right now, so patients really don't know whether it's safe for them to use or not when they take things over the counter.

We would also recommend that the Therapeutic Products Programme consult with the college, the faculty, or other expert naturopathic physicians on appropriate and current scientific literature that relates to the substances we use, as well as on the traditional literature that relates to the substances we prescribe, related to both the indications and the contraindications of that system. We also recommend that this safer scheme of substances be available to individual practitioners who have demonstrated competence. Again, competence is defined as training, both academic and clinic, plus licensing and examination.

We would also ask that when the Therapeutic Products Programme are proposing to ban substances, as they have done, they consult with the naturopathic community, with the naturopathic college, with our physicians and our experts, and with members of the complementary care industry about what items should be banned, what should not be banned, and what category they should be put in, as we're really the experts in the area. We've spent four years doing this kind of training, we have pre-training in this, and we can offer them some valuable services that they don't have at this time.

We would also encourage them perhaps to take on a naturopathic physician, either in a full-time capacity or on a sabbatical leave or whatever, to help them establish and define, through this scientific literature, what substances are safe, what are not safe, and how they can be used appropriately.

In conclusion, the Canadian College of Naturopathic Medicine supports regulations that will provide Canadians with a wide selection of safe, natural remedies to both treat and prevent disease. Naturopathic physicians are the only regulated and licensed doctors throughout Canada who are trained in the safe use of natural substances, and this competence is based on training and examination upon graduation.

The United Nations has estimated that over 80% of the world's population rely primarily on botanical medicines for their primary health care. Canada now has a unique opportunity to be at the forefront of regulating the safe use of these medicines, which have been available to literally millions or even billions of people abroad. We also have the opportunity to make these medicines available to Canadians in a safe, effective way that will, through appropriate regulation and access, see that they do not interact with the pharmaceutical substances that Canadians are taking, and that will allow patients freedom of choice for their physicians and health care. This will also then allow us to pursue research avenues and look for treatments and cures for new and old diseases.

Thank you.

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

The next speaker.

Dr. Lois Hare: I am a naturopathic physician practising in Berwick, Nova Scotia. I'd like to introduce Heather MacFarlane, executive director of the Canadian Naturopathic Association, which I represent.

The Canadian Naturopathic Association represents the interests of naturopathic doctors and promotes education regarding naturopathic medicine in Canada. That's our role. What brings us here today are our concerns regarding the current regulation of natural health products in Canada. We have some concerns about the way things are being regulated.

In our presentation there is a summary of our concerns and recommendations, on page 17.

It's the view of the CNA that natural health products are neither foods nor drugs and should be regulated on their own merit. They require their own distinct category, with a separate administrative unit of qualified staff who have the authority to develop and implement policy. That is the grounding for where we're coming from.

The current regulations of natural health products are having a negative impact on naturopathic doctors' ability to treat their patients effectively. There are three areas of concern.

First, we are concerned that we have ensured the availability of the products we use in naturopathic practice. These are medicines we are trained to prescribe and to dispense, and we want to ensure that we have access to them.

We're concerned about the safety to the public and to our patients with regard to the quality and the content of medicinals, as Dr. Saunders pointed out. We really want to support the appropriate labelling with regard to indications, contraindications, and dosage of natural health substances.

Our third concern is consultation and communication between the regulatory body and our profession. I'll go into these in more detail.

In terms of access, under the current Food and Drugs Act controlled substances are restricted to professions designated as practitioners. We're not, as naturopathic doctors, presently in this category, which does result in restricting access to certain medicinals we are trained to prescribe.

It's interesting that a number of other health care professions are included as practitioners, so have access to medicinals that they are not trained to use. They have access to those medicinals. We would recommend that naturopathic doctors who have graduated from a recognized naturopathic medical college be included in the definition of “practitioner” under the current Food and Drugs Act.

We also recommend that NDs be included under the special access program, known in the past as the emergency drug release program, as there are also medicinals there that we would have knowledge of and require for prescription.

We also have a concern from the profession regarding the impact of the proposed established licensing initiatives. Should they come into effect regarding the importation of natural health products, NDs, who are primary health care providers...and we're not retailers. We're not commercial importers. There are medicinals we bring in from other countries, though, because they're not available in Canada at this point in time. We're hoping manufacturers will eventually bring those in, but at this point in time, they aren't being imported.

Naturopathic doctors do bring those into Canada, and we're recommending at this point that these trained professionals be exempt from the established licensing initiative and from any regulation that puts restriction on our ability to import the substances we require to treat our patients.

There are uncommon, or not widely available, botanical and homeopathic medicines, and we're concerned that some of these may disappear if the cost-recovery program forces small manufacturers out of business. I heard Joel Thuna refer earlier to the fact that small manufacturers may be forced out of the market.

Now, one of the things that has happened over the years is that in terms of these small remedies we may be using as naturopathic doctors, the small companies, knowing the efficacy of these medicinals, have kept them available. They're not really a lucrative market and a larger pharmaceutical company may not deem them necessary or deem it cost-efficient to produce those products.

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So we are recommending that any cost-recovery program for the natural health products industry be fair and reasonable and not limit access through the closure of some of these companies.

Our second area of concern is safety, that is, safety of the products available to the public. I've mentioned labelling as one of our concerns. We're also concerned that individuals can import products from the United States that are not available here in Canada. They can order anything up to a three-month supply. That would mean there has been no checking on quality, no control of these substances. We can't get them here in Canada. The manufacturers here in Canada aren't able to produce them, and yet individuals are able to import them. That seems somewhat ridiculous to me. We'd like to bring that forward to the committee to make you aware of that.

In April of this year, we met with the senior policy adviser for the health minister at that time, David Dingwall, and at that time Mr. Genest really reinforced to us that he would like to see more research being carried out in terms of naturopathic medicine and natural therapeutics, which we agreed with. At that time, he suggested that there may be moneys made available through the National Research Council or from some direction through the federal government.

It's quite clear that a natural health product, by its own definition, cannot be patented. There's not a lot of reinforcement to companies to do research in that area if they can't patent a remedy or a medicinal, because then anyone can use it and have it for sale. It doesn't really reinforce a tremendous amount of research moneys.

So we're recommending that a process be developed to enable the CNA and Canadian College of Naturopathic Medicine to work with appropriate personnel within Health Canada to direct research funds for collaborative research partnerships with regard to safety and clinical effectiveness of natural therapeutics.

In terms of consultation and communication, we have been regulated. Naturopathic doctors in the province of Ontario have been regulated since 1925. Our expertise in this area has been well grounded over many years of being regulated and recognized as health care professionals.

The Therapeutic Products Programme has never really used the extent of our expertise in their regulatory framework or in their decision-making process. We have been included on different committees, but we feel that the advice that we've given and the suggestions that we've offered to the program are not understood outside the conventional medical model. The people in the TPP are not educated or trained in terms of natural health products. We find that sad, because they could be utilizing our expertise. We're available and they're not using us, this very broad resource.

So the result is an inappropriate determination of risks and benefits of the natural health products, and then we get subsequent withdrawal from the market and loss of their acceptability to naturopathic doctors, and also to the general public. You've heard the hue and cry in the media about the different withdrawals and then public outcry about the restrictions.

We're also concerned that in this time of financial restriction and with the cost-recovery program that's being brought into play...it seems financially irresponsible for the Therapeutic Products Programme to utilize staff who are without the necessary training to evaluate these products. They need to bring in some health professionals who know about natural health therapeutics, and we're suggesting that we would be beneficial to their program.

As health care professionals, we need direct communication with the TPP. As it is presently, they don't include us in information. We're told to go to the website. The public has access to that website, but we're professionals and want direct access if it's something that will impact our ability to deal with our patients and give them our expert care.

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So our recommendation 8 on our listing is as follows: an effective communication system is put in place to keep the Canadian Naturopathic Association and its members informed of any regulatory changes or initiatives which affect the practice of naturopathic medicine across Canada.

To reiterate, naturopathic doctors are experts in the field of primary health care. We're recommending that the health committee ensure the availability of natural health substances through all the areas of regulation so naturopathic doctors are able to prescribe and dispense the medicines we're trained to prescribe and dispense, and that we require for safe and effective treatment of our patients.

It's the belief of the Canadian Naturopathic Association that a separate category for the regulation of botanical medicines, homeopathic preparations, and nutritional supplements distinct from pharmaceutical drugs and conventional foods, with a separate administrative unit, could easily incorporate all of our recommendations.

This initiative will require significant and ongoing consultation with the naturopathic profession. It will result in full access for naturopathic doctors to the natural remedies we are trained to use and are essential for our effective treatment. We're here and we are available for consultation and for any access that's needed.

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

Heather MacFarlane, did you want to speak?

Ms. Heather MacFarlane (Executive Director, Canadian Naturopathic Association): No, I'm here to answer some questions, perhaps.

The Vice-Chair (Ms. Elinor Caplan): I'm going to have the speakers from the college next and then Dr. LaValley. Who would like to start off?

Dr. Fernando Ania (President, Homeopathic College of Canada): Thank you very much. We really appreciate being here. My name is Fernando Ania. I'm president of the Homeopathic College of Canada. I'm fortunate to have Dr. Szymanski from the Pacific Homeopathic Association of British Columbia joining us in this submission, and he will be kind enough to read it. Be aware, please, that some sentences will be not read from the written submission due to time restraint.

Dr. Szymanski, please.

Dr. Geoff Szymanski (Homeopathic College of Canada): Good morning.

Homeopathy was the first system of medicine to be regulated in Upper Canada in 1859, ten years prior to conventional medicine, and required a four-year doctoral program. Homeopathic medicine continued to be regulated in Ontario until 1970.

Homeopathy is once again becoming a new medicine of choice for many Canadians. To this end, the International Academy of Homeopathy, and later the Homeopathic College of Canada, follow the mandates and standards of Ontario Homeopathic Association and the Homeopathic Medical Council of Canada.

Our first graduating class was in the summer of 1994. In 1993 we estimated there were very few properly trained homeopaths in Ontario. They were mostly immigrants or had been trained outside of Canada. We are concerned about the number of people claiming to be homeopaths and wonder about the quality of their training.

The last homeopathic medical school to close in North America was in 1936. We're the first school to open a full-time program in North America based on the regulated standards of 1859 for homeopathic doctors. We use homeopathic medicines, botanicals and nutrition, and nutritional support. Our program consists of nine semesters and over 3,000 hours. Humber College teaches the science curriculum at a university credit level, and unfortunately universities have not yet been open to alternative medicines.

We are not subsidized and have been denied Ontario students assistance program for the past four years, even though it was granted to shiatsu, naturopathic and computer schools.

Given the fact that the federal government is searching for ways to cut health care costs and recognizing that the general public is utilizing complementary therapies on an ever-increasing basis, we maintain that homeopathy offers an effective and economical complementary modality to conventional medicine.

Alternative treatments have been perhaps unwillingly suppressed. We offer solutions to our health care system with safe, effective treatments for many common ailments from colicky babies to cholera, ulcers, arthritis and some cancers.

In 1997 we conducted a pilot study on arthritis using individualized prescribed homeopathic remedies and a standardized botanical medicine. We showed the effectiveness of alternative treatments with an improvement in 80% of the patients. There are 4 million arthritic patients in Canada, with a cost to the Canadian economy of $8 billion annually. The application of these treatments could save the Canadian economy from $1 billion to $3 billion annually, reduce the arthritic population considerably, and relieve much unnecessary pain for millions.

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If the outcome we desire for people is better health, so should be the approach. Of all the factors affecting health, treatment is only 25%. Therefore any treatment should be carefully considered for its effect on total health rather than on the disease alone.

Wholesome foods promote health. The public must be aware of the different kinds and levels of foods, and they should be labelled. It has been said and published that 50% to 60% of cancers can be prevented by wholesome nutrition. Complementary treatments consider first health and then the disease. For health, a shift in the conventional medical paradigm is necessary.

Homeopathy is a system of medicine using a homeopathic remedy which, when administered in health, will produce symptoms similar to those for the relief of which it is given in sickness. It follows specific scientific principles and experimentation and is a scientific system of medicine.

Homeopathy is covered under the national health system in Great Britain when recommended by homeopathic doctors. An application of homeopathic principles led to the discovery of vaccination by Jenner, as it did to the discovery of nitroglycerine by a homeopathic physician, a medicine still very much in use today and still used homeopathically, under the tongue.

The homeopathic methodology, based on the laws of similars, presupposes full knowledge of the individual case, the action of homeopathic medicines in the healthy body, and the ability to match one set of symptoms to another. In homeopathy every case is individualized. Only homeopathic doctors and other doctors with postgraduate courses in homeopathy have the therapeutic and clinical knowledge necessary to prescribe in this manner. Only trained health care professionals can successfully prescribe for acute conditions such as colds, flus, traumas, and sprains—and always in an individualized case.

There are only several exceptions where we can prescribe by the name of the disease. An example would be for trauma and emergency medicine, where the general prescription must be given immediately.

The Homeopathic College of Canada has developed a program for pharmacists upon the request of the Ontario College of Pharmacists.

Standards: It is imperative that standards be followed in homeopathy as in other medical systems, such as conventional, osteopathic, chiropractic, and naturopathic. Regulating homeopathic remedies without regulating homeopathic doctors is like having standards for the manufacture of cars and then allowing anybody without training to fix them.

Regulation of medicines: In Canada a number of homeopathic remedies, such as Nux vomica, Arsenicum, and Ignatia, have been proscribed on account of the known toxicity of their crude substrates. We wish to emphasize that homeopathic remedies may present little danger to the public, and in a toxicological sense only. This schedule of proscribed remedies should accordingly be rescinded.

There is, however, a risk involved in prescribing homeopathic remedies on an uninformed basis. Homeopathic remedies can cause side effects on a functional level and serious aggravation if not properly prescribed. For example, in an acute asthmatic attack the wrong remedy can send a child to the hospital. The inappropriate remedy in tuberculosis could cause an increase in the illness and a progression of the illness. Because of the potential risk of harm, we suggest only qualified homeopathic doctors should prescribe homeopathic medicines.

Sold over the counter are various remedy complexes consisting of two or more homeopathic remedies in low potency. These are advertised as remedies for specific conditions such as headache, toothache, and PMS.

In homeopathy we do not associate homeopathic remedies with disease conditions. By definition, homeopathy is treating with similars. That is, the symptoms of the person are matched to the symptom a single remedy can produce or mimic. Also, we use only one substance at a time. Our knowledge of medicines is based not only on the homeopathic pharmacopoeia but on the materia medica and clinical experimentation. There is no body of homeopathic literature on the proper experimentation that supports the claims for these commercial combinations. Also, the sum of several remedies does not constitute the sum of the individual medicines but is a completely new entity.

Only a homeopathic doctor, knowing the individual homeopathic remedies, can appropriately consider the indications of a particular compound containing different homeopathic remedies for a particular patient. By definition, remedy complexes are not homeopathic remedies until prescribed by a homeopathic doctor. Self-prescribing complex remedies may present a risk to the public...based on the hope that one of the remedies will be the active one. It could definitely cloud the case and even render some people homeopathically incurable.

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We are greatly concerned about the health of Canadians. Presently, homeopathy is not a regulated profession in Canada. The following are some of the facts we have seen in Ontario.

Currently there are several seminars on homeopathy given by people with different backgrounds and offering diplomas in advanced homeopathy, with no prerequisites for admission. We only now have a handful of true experts on homeopathy in Canada. In order to be an expert on homeopathy, a vast clinical experience is required. We know of students who, after approximately 100 hours or 180 hours, have dropped out of the school and opened homeopathic schools.

We believe that simply knowing about antibiotics and reading about anatomy does not make anybody a medical doctor. This sort of discrepancy and lack of professionalism makes it difficult for us to seek regulation. We believe that we cannot educate half a medical doctor, or even half a homeopathic doctor. The risks are obvious.

We have similar concerns regarding natural health products. We have been researching and developing different natural health products. This was necessary due to lack of research in contemporary clinical application and quality. One specific product showed enormous benefit for arthritis. A company was created with the aim of bringing this standardized product to market and supporting our institution. In appendix 7, the final product can be compared to all the other products on the market, and the savings thereof. It was the only standardized product out of the 11 products on the market.

Unfortunately, we will not be able to continue research and develop solutions unless there is an economic return. This return is difficult to obtain, since natural products cannot be protected by law. It is no wonder that drug companies are only involved in research and development of patented medicines, and that therefore natural health products are not fully explored and utilized for the benefit of humankind.

HCC follows guidelines for the classification, research, and clinical use of natural health products. See appendices 8 and 9.

Recommendations:

1. That homeopathic medicines and natural health products be classified in two different categories, neither foodstuffs nor drugs.

2. The current proscription on certain homeopathic remedies should be immediately lifted. Only qualified homeopathic practitioners should have full access to the complete range of remedies itemized in their materia medica.

3. Homeopathic medicines should only be available to trained homeopathic doctors and other trained doctors, except for over-the-counter homeopathic remedies.

4. Over-the-counter complex remedies containing individual homeopathic remedies should not in any way be referred to as homeopathic. They should be restricted to self-limiting acute conditions only.

5. Pharmacists should be trained in homeopathic pharmacopoeia and over-the-counter dispensing.

6. The following should be defined, regulated, classified and labelled: processed food, genetically modified food and irradiated food.

7. Regulate the word or the claim “natural”.

8. Fund research in alternative and complementary medicine through speciality teaching institutions, such as HCC and universities.

9. Change the food and drug definitions.

10. Add a homeopathic doctor to the advisory panel on NHP and to the expert advisory committee.

11. Create a permanent panel of qualified homeopathic doctors and other doctors or an office of alternative medicine such as that created by the National Institutes of Health in the U.S.A., in order to:

- determine the benefits and cost-effectiveness, uses and risks of alternative health treatments;

- ensure that homeopathic medicines are manufactured according to the homeopathic pharmacopoeia we follow in Canada, and that other natural health products are manufactured according to their corresponding standards and their claims;

- regulate the advertising of complex remedies where low-potency compounds are promoted as a substitute for professional care;

- ensure, by the federal government, that the provinces take the immediate and necessary steps to regulate homeopathic doctors, and that institutions at the university level, such as HCC, obtain financial assistance for their students;

- recommend that medical, nursing, and pharmacy schools in Canada integrate and teach to their health care professionals introductory homeopathy, and only by qualified homeopathic doctors and teachers.

Thank you very much.

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

Is there anyone else—Dr. Hare?—other than Dr. LaValley, who wants to speak from the panel?

A voice: No, thank you.

The Vice-Chair (Ms. Elinor Caplan): Dr. LaValley.

Dr. J. William LaValley (Founding President, Canadian Complementary Medical Association): I'd like to ask the administrative assistant, wherever that is....

The Vice-Chair (Ms. Elinor Caplan): We'll have that distributed. Someone will come and pick it up.

Would you start by introducing yourself again, Dr. LaValley?

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Dr. William LaValley: My name's Dr. William LaValley. I represent the Canadian Complementary Medical Association. That's the hat I'm wearing today.

We've thought long and hard about the issues that are presented to you, and have tried to look at it from your point of view. Along with Dr. Hare, who I've known for many years, Dr. Ania, and I assume also Dr. Saunders, we sit at ground zero with this issue. We see the people who are suffering desperately. We have to deal with the restrictions, the limitations and the issues on a daily basis, year in and year out.

What I have with me is something that I'd like to pass around. Rather than going back to the background and describing the Canadian Complementary Medical Association and all the other information, I'm doing this because it's clear to me that you've already gotten very good, appropriate, satisfactory background information. What I'd like to do instead is jump to solutions, and then give some descriptions that justify why these solutions are being recommended by our organization after having studied the issues in a very detailed way.

Picture the following—and this is not meant as personal, so I hope no one takes it in a personal way; it's meant rhetorically. Consider yourself or a loved one, a family member who either suffers or who has suffered from some very intractable chronic disease. The suffering is desperate. Seeking conventional care, whether that's surgery, pharmaceutical drugs, radiation, or whatever the conventional care is, has helped. It certainly has been available and somewhat effective, but has no further benefit or you can't tolerate these drugs or another surgery. Perhaps you've been in a circumstance such as this, or perhaps you know someone who has. I know everybody at the front here certainly knows many who have, and I see these patients daily.

With no further options in the conventional arena, and with this widespread availability of information that is available about natural health products, you're then confronted with the questions around the circumstance of what to do. You can either go down to your local pharmacy, where there are some natural health products available; or you can go to the health food store, where there may be a little bit more; or you can read some of the magazines or jump on the Internet to find out that there is a wide variety of these things available.

With the wide access to information, you then subsequently have options that were previously not available. You also have the knowledge that the options you could otherwise have are not available here in Canada. If you look around to find out why they're not available.... Well, you've all been given background information as to why that situation exists, and that's why we're here today. The bottom line is that there are a lot of natural health products that are not available.

Last week I was down in the U.S., in a run-of-the-mill, average pharmacy in a very conservative state. It's one in a large chain of pharmacies. Picture 60 feet to maybe 80 feet by 8 feet by 2. There were two racks of natural health products just in the pharmacy. All of these are available over the counter. There's no restriction, no product licensing fee, no establishment licensing fee, no safety issues that are before the manufacturers in the United States. It's distributed under the Dietary Supplement Health and Education Act. I am sure you're familiar with the acronym called DSHEA.

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What these products represent are products that have a very wide margin of safety. If there is harm...and I want to make it very clear that the Canadian Complementary Medical Association is very supportive of safe, accountable products that are what they say they are. Essentially what we're looking at is how to assure that safety and how to assure that accountability while at the same time having the widest open market for these products in a way that's going to be the most cost-effective for the consumer. We want to be sure the consumer has appropriate information available upon which to make decisions and that the safety of the products is guaranteed over the long term.

When these products are made available in the United States, if there's a problem with the product, then the FDA in the U.S.A. has the onus to prove that there's harm from the products to take the products off the market. We recommend instead that there be what we term a universal onus. That means anybody, not just limited to the Health Protection Branch but anybody, can have the right—and in fact has the responsibility if they have the information—to report any problems with safety, with toxicity, with adulteration, and with any mislabelling. And in fact this way we will bring greater accountability to the field.

What we're recommending is the following. Yes, we do need to have an appropriate third category because these products are inherently unique. They're different from pharmaceutical prescriptions and they're different from foods. That's important; and it's also important there be an expertise that's inherent in the personnel who are hired for that third category, for the regulatory apparatus, so that there is an appropriate background basis of information upon which to make these decisions. It's also important that the decisions for products be based on whether a product is a high-risk product or a less-than-high-risk product. That's the distinction we're describing. And I think it falls very well within what Dr. Saunders was presenting and also what Dr. Hare had spoken about.

We're talking about many thousands of products. Under analysis, looking at, for instance, a highly regulated model where every product goes either through notification or through pre-market review...what we're going to end up with is a logjam of products that Canadians are not going to have available to them.

If these products had a low margin of safety, then we would have much greater concern. But when we look at the way these products are available in the United States, in millions upon millions of doses daily, and we ask about the concern for safety, that there are no body counts, or very few....

When we look at the issue of the ephedrine, that was where a product was inappropriately formulated and then abused. And there was death that occurred. Absolutely, that product should be taken off the market and only appropriate doses with appropriate indications should be allowed on the market. We support that. What we're opposed to is inappropriate removal of products either because of bias or misinformation or because of manipulation in order to have less competition with some of the other industry groups.

Looking at the concern about how these products are going to be regulated relative to the claims, right now in the United States essentially claims can be made on any of the natural health products and there is very clearly a disclaimer required. You'll notice on these products that not all of them have the disclaimer, but that disclaimer is required and it must say that the product has not been evaluated by the Food and Drug Administration for the diagnosis, treatment, or prevention of disease.

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We're saying that because the amount, the sheer volume, of the number of products and because of the wide margin of safety, products that are of less than high risk should be subject to open market availability. This open market availability should also be subject to specific criteria, such that the products are what they say they are, and that every product has full disclosure labelling with the quantity of the product that's in there.

This is so we can avoid what some have called the “pixie dust” phenomenon. This means writing a bunch of nice words that say there's a lot of nice product in there, yet there are only one or two pieces of it. It may perhaps be one or two molecules, and it's not being described as homeopathic.

So what we're looking for is greater accountability, and anyone who has evidence that there is toxicity, safety risk, adulteration, or mislabelling can bring that information forward.

That changes the dynamic in the market. That makes the market much more efficient itself. Products that are ineffective are not going to survive very long. Competitors are going to be analysing one another's product. It's going to suggest to those in the industry to be more accountable to themselves and to the industry.

So consider this scenario again where you have the desperate suffering. You have basically three options. One is to do nothing in natural health products. Another is to seek information, and get it from Canada locally under the current options. Third, go out of the country.

Now there's mail order, the Internet, and bordering. Basically it's very easy to get door-to-door service of these products. They'll be delivered directly to your door without product licensing issues, establishment licensing issues, analysis for safety or toxicity, or an assessment of claims.

This is essentially under what's clearly an unenforceable policy that says it's limited to the three-month volume of that product. Now, if you look at that policy, it's arbitrary; it won't hold up under a legal challenge. Because it's not in regulation, essentially someone could bring in as much as they want for personal use.

That addresses the issues of the economics, because there aren't safety issues. The economic issues become ones whereby instead of Canadians importing these products in a commercial way or Canadians manufacturing these products, these products are imported for personal use only and at a lower cost.

What we do is jeopardize the Canadian complementary health care industry. If you're suffering with this type of information available, there's a great and increasing likelihood—there are widespread polls that will validate this assertion—that you'll find the information, have it available, make the 800-number phone call, and have it delivered to your home.

So we get to the point of asking, are we going to recommend that we're facilitating essentially out-of-country health care that's being brought in because of the ease of this delivery, or are we going to be realistic about the options that are available?

Those that have this wide margin of safety and those that are going to be available to the consumer anyway, except not in Canada, will be out-of-country. Are we going to allow Canadian industry, the Canadian complementary medical and health care community, to participate fully and appropriately, or are we going to put what will essentially be a bureaucratic and artificial logjam that will hinder access, limit availability, and raise the prices exorbitantly, because where are we going to get the money to pay for this regulatory apparatus? Through the policy of cost recovery. And where are we going to find the people who have the expertise in the industry—we had a long discussion about this—who are willing to come to Ottawa to work for the government, to work in the bureaucracy, and who are acceptable to the industry and to the Government of Canada? A very tall order at this point!

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Instead of the government approving or disapproving each one of these products, perhaps we can begin to look at the government as a body for assessment and arbitration, assessment of complaints and violations in labelling and assessment of any concerns about adulteration or inappropriate inclusions in the product. Then the government would have a much smaller apparatus that's more efficient, and if there is any concern about safety, the product can be withdrawn immediately.

We're not saying to have no coding for the use of these products. Certainly it's appropriate to consider some sort of coding so that if there needs to be a withdrawal or recall of a set of products they can be recalled. However, the requirements of the so-called drug identification number or the natural health product identification number, with high fees, with high establishment licensing fees, is ultimately not going to stop the consumer from getting these products.

What we see happening is that companies in the United States will flood the Canadian market with 1-800 phone number catalogues, which will contain the indications and the uses of these products. And when you have a concern or a problem, you'll go to your next-door neighbour or your aunt or your cousin or somebody who has this catalogue—or maybe you'll have it yourself—and make a quick phone call and have these products being delivered to your door two days later at a lower cost than is available in Canada, and without all of these other restrictions.

So what are we going to do? There is a clearly heard strong desire within the health care community, the competent health care community, to have products that are safe and that are what they say they are. So are we going to agree to that?

However, that type of bureaucratic assessment that is either under notification, especially pre-market assessment...it is going to limit and constrict the industry in the long run in such a manner as to drive these products (a) underground, which is where a lot of them are now, or (b) people will get them over the Internet or over the phone or through faxes or whatever. Otherwise, you change the law on import for personal use, and there seems to be little likelihood within the field to do that.

The Vice-Chair (Ms. Elinor Caplan): Thank you very much for the presentation. I gave some leeway in order to allow the presenters to finish. I'm not going to be as lenient with the members. We have about 20 minutes left.

Mr. Vellacott.

Mr. Maurice Vellacott (Wanuskewin, Ref.): I have a question for Dr. Saunders that gets to the kind of curriculum, I guess, that you offer at your college.

There are seven different categories. Now, am I to understand that's required of all of your students, all your graduates?

Dr. Paul Saunders: That's correct. All of the students would be taking courses in this particular area. They would be studying all of these areas, and that's why we're regulated as sort of the generalist in the complementary health care area. We're not saying that we're specialists in homeopathy or botanical medicine but that we're trained at the generalist level. Then students who wish to specialize can do that in post-graduate study after they finish the ND.

Mr. Maurice Vellacott: Your graduates would go out possibly then—you have to answer this question correctly, I mean cautiously—

Dr. Paul Saunders: Okay.

Mr. Maurice Vellacott: —because we have the homeopathic college here as well. But for example, then, could they go out and practise in the area of homeopathy without additional study? What are you saying?

Dr. Paul Saunders: No. They would have the minimum requirements to be able to practise homeopathic medicine. If they wish to pursue advanced training, for example, they can do that. For example, on our cover page, you'll notice that after my name, there is that last set of initials, which means that what I've taken is a board-certified exam in homeopathic medicine through the American Association of Naturopathic Physicians. That has required three years of additional training and examinations. But it doesn't mean I can't practise safe homeopathy at the end of this time, because not only do the students study it but they demonstrate it in a clinic and they have to demonstrate it in a licensing exam. Nobody else does that.

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Mr. Maurice Vellacott: So students coming to register at your school have access to provincial loans, grants—

Dr. Paul Saunders: They have access to provincial loans. They have access to federal loans. If they come from the States they have access to American loans. We get some American students coming here.

Mr. Maurice Vellacott: Right. It's a bit different from the Homeopathic College of Canada.

Dr. Paul Saunders: That's right.

Mr. Maurice Vellacott: The other question I have, then—this has always interested me as a consumer—is this. When a naturopathic practitioner is selling a medicine...I'm prescribed to take this particular thing, and then he's the one who dispenses it. Help me on that a little—the perceived conflict of interest or self-interest—

Dr. Paul Saunders: You're right, there is a potential perception of self-interest and conflict.

We are required to have a sign over our dispensary that, first, says to the patient, you can buy it here or you can buy it elsewhere. We are limited in how much we can mark that product up over our cost. The licensing board does that and it polices that.

You will find that most people who have dispensaries are in small towns. For example, I practise in a town of fewer than 20,000. Most pharmacies are not willing to carry the kind of products you saw from, say, the Thunas this morning, or something like that—that list of botanicals. In the course of a week I might prescribe 150 different botanicals or 200 different homeopathics or something like that. They don't have that available. I have that.

So the patient can get it from me. They can get it from somebody in Toronto. They can get it mail order from a company out of Toronto. It's their choice. I am simply providing that service to them if they wish to avail themselves of it.

Mr. Maurice Vellacott: And you are required to make that clear to your—

Dr. Paul Saunders: I make it absolutely clear. If I don't, I have a licensing board and a regulatory body; when there's a conflict, they complain and I get investigated. I haven't got investigated, but that's the process. That's what regulation is all about. That happens with all naturopathic doctors in all the provinces.

Dr. Lois Hare: At one point Dr. LaValley and I were the only practitioners in Nova Scotia who were carrying homeopathic remedies. If they didn't get it from either his office or mine, they would have to go somewhere outside the province of Nova Scotia to gain access. That's changing now, but that's the way it was when I first started practising 11 years ago.

Mr. Maurice Vellacott: So other MDs were saying they didn't have a dispensary. Then they would actually come your way.

Dr. Lois Hare: They would have to, but only if it was another naturopathic doctor, or if Dr. LaValley needed a remedy...not from the public. The lay public are not allowed to buy out of my dispensary. It's not an open dispensary.

Mr. Maurice Vellacott: I see.

Dr. Paul Saunders: Right, and that's a point I made in here. It's available only to my patients. I'm not competing with Shoppers Drug Mart or anybody around the corner. It's only to my patients. In fact, people come in and ask if they may buy this echinacea, for example. We say no, if you're not a patient, you can't buy it. It's only for patients. It's only for patients.

The Vice-Chair (Ms. Elinor Caplan): Mr. Myers.

Mr. Lynn Myers: Thank you, Madam Chair. I have a question for both Dr. Saunders and Dr. Hare about the final points they were making in their submission; that is, that all these recommendations will help fuel research. I wonder if they could elaborate on that and give specifics on where that could go or what could happen in that area.

Dr. Lois Hare: Some research is happening at this point. Are you interested in what is actually going on at this time?

Mr. Lynn Myers: I'm interested in what is happening now and in what could be projected; if we followed your recommendations, what could be down the road as a result of that.

Dr. Lois Hare: Okay.

Right now Sunnybrook Hospital is doing some research into ovarian cancer and it has asked for collaboration with the Canadian College of Naturopathic Medicine so we can give input on the types of therapies people are using in collaboration with their oncologist, that type of thing. That's one area that could definitely be broadened.

We're doing collaborative clinical evidence-based evidence with Bastir University, the Canadian College, Southwest College, and National College.

Dr. Saunders, do you want to talk about that?

Dr. Paul Saunders: Yes, it's an international project. It's actually a joint project involving schools in the United States and in Canada. It's a program on breast cancer—women who have had breast cancer and the types of treatments we're looking at. So it's an outcome study: what things we are providing to these patients, what their survival rate is, and how they are handling that.

We have another joint project, one that's looking at a formulation of echinacea; not this particular one but one that's available for children. It has a glycerated base and it has been used in young children up to five years of age and children five to ten years of age.

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We have a joint project with the Hospital for Sick Children in downtown Toronto looking at how well family physicians are aware of botanic products and how much they check this information out with women who are either pregnant or lactating or considering getting pregnant. We're involved in a study like that.

We have another one going on with irritable bowel syndrome, looking at naturopathic therapies for that. We're in the process of applying for some with arthritis and so forth.

So we have some things ongoing, but if there were actually more grants available that were focused on complementary medicine or the kinds of therapies we do, then we could demonstrate what's effective and what's not effective. We're very much interested in getting involved in that kind of research and working with universities.

Mr. Lynn Myers: Thank you.

I have a quick question for Dr. LaValley.

I was interested in your suggestion that people would report on each other and each other's products and such. I think you snapped your fingers and said everything would stop and it would be investigated. Would it be that simple? Wouldn't I, as a competitor, for example, phone up and say, “Wait a minute; this product should be withdrawn”? And wouldn't there be huge complications and backlogs in the system?

Dr. William LaValley: Well, if the system is organized in such a way as to anticipate that type of abuse prior to it, then the evidentiary basis required for you to report adulteration or mislabelling would be very clear, and you would have to meet those criteria. At that point, whatever is in place—let's call it the natural health products program—would then make a determination as to whether there was a safety risk or potential toxicity or harm, and if there were, would take the product off the market.

Clearly we're not saying the government should not have the right to take a product off the market if it suspects there's a problem. We also do not recommend that it have a reflex reaction and take a product off the market just because a competitor says there's a problem. There would have to be a certain criteria basis for that vigilance within the market to be appropriately integrated.

We're looking to assure that products are safe and that there's an accountability within the industry, and that the industry can participate in this in a way that it hasn't done up until now, except in an abusive manner. That also shifts the onus from just the particular manufacturer or just the Health Protection Branch, or Health Canada. It allows the onus to be shared so the products are most efficiently monitored.

Right now, if you look at quality control testing, there essentially isn't any. Products aren't randomly taken off the shelf for product control testing very frequently. Where there are concerns is when other manufacturers bring those concerns up. I think that is the process you're talking about, and in fact it has been abused in the past.

At this point, if all of the thousands and thousands of products that will be available, or ought to be available, are going to have to be brought through some committee or before one or two people who will decide whether or not the safety evidence—because clearly we're not talking about efficacy evidence, but the safety evidence—is appropriate, then we're not going to have these products on the market.

People will still go get them. They're going to get them down through the United States, where there is no control at all. So what we're looking at is what's a practical, safe, realistic option?

Mr. Lynn Myers: Thank you very much.

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

Ms. Wasylycia-Leis.

Ms. Judy Wasylycia-Leis (Winnipeg North Centre, NDP): Thank you very much. I have a question for each group about the Advisory Panel on Natural Health Products.

To the representatives of the Naturopathic Association, you have a representative on this panel, Anthony Godfrey. Does the draft report reflect the concerns you've raised with us today, and is it going in the right direction?

To the homeopathic doctors, I know you've made a recommendation for a representative on that panel. Are you making any progress? And in the meantime, what is your sense of this draft report?

And to Dr. LaValley, you are on the panel. Is what you've said today reflected in the draft report?

Dr. Lois Hare: I'll have Heather answer that, please.

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Ms. Heather MacFarlane: On where the advisory panel is with its draft, I understand it's a work in progress. We were concerned that when it came back in report form from the TPP staff it was unrecognizable as to what was put forward by the panel members. Just before it came to this standing committee it was changed, but changes are still required to adhere to the panel members' work. So it's still considered a work in progress. I believe the next meeting of the panel is around March 2.

Dr. Fernando Ania: We have not approached or made a positional request to be included in the panel, but this is also a symptom that we have not been approached. We would have liked to be approached first because we were aware of this panel only after it had been formed for some time. We've been functioning for almost 10 years in conversation with the different levels of government. I think we should have been approached. We would like to apply to be a representative from the profession, because it is our concern that a special homeopathic doctor should be on the panel.

Dr. William LaValley: As a member of the panel, it's very clear that the recommendations I made as representative for the Canadian Complementary Medical Association are significantly different from what the panel is recommending. The panel is recommending what's called notification or pre-market approval, which is a very high bureaucratic burden and a high evidentiary basis burden, wherein if the apparatus that is established for this regulation doesn't have people who are unbiased, extremely well educated, expert in the actual clinical delivery as well as the science, and willing to work within the bureaucratic limitations of the government, then the whole thing falls apart.

We're looking at it from the point of view of what will have the greatest likelihood of the greatest safety to the greatest number of people at the lowest cost in an open and transparent way, looking at just those less-than-high-risk products in an open market. Anything that might be high risk is specifically defined as requiring a practitioner. I think Dr. Saunders also described that.

We're saying that regardless of whether it's a medical doctor, a naturopathic physician, a chiropractor, a dentist, a homeopathic doctor or whatever. That specifically has to do with provincial jurisdiction and recommendations through legislation in the provinces. We're making a recommendation of that. Obviously this committee isn't doing provincial law.

Ms. Heather MacFarlane: Our concern right now is that the mandate of the advisory panel was changed after the announcement that the standing committee would be formed, yet the membership on that committee was not changed. It started out to be an herbal panel, and that is one of the reasons why there isn't an expert in the homeopathic area. We put forward a person who particularly specializes in the herbal area as a naturopathic doctor.

Dr. William LaValley: I want to make it very clear that for these less-than-high-risk products a very clear disclaimer would be recommended that says the product claims, if there are any claims, have not been evaluated or approved by Health Canada for any diagnosis, treatment, cure or prevention of disease. Any warnings would be included, such as for pregnancy or drug interactions if they're known. However, it isn't the responsibility of the government to validate or verify the claims in these very safe, high margin of safety products.

The Vice-Chair (Ms. Elinor Caplan): I would like to follow up on that because there are two products you distributed that I call your attention to. Mr. Vellacott is holding one in his hand, and the other is an identical one that does not contain the warning. While the disclaimer is there, it doesn't have the warning. For the committee, I wonder if you could explain the...I think it's chromium. Tell us what it is. Both are permitted under the U.S. model.

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Dr. William LaValley: Actually, one of them is mislabelled.

What I'm saying is there's a wide variety of things going on down in the United States. People are going to be able to get in here under the import for personal use, by our having a requirement for appropriate labelling that includes warnings, allows the claims...because we're not looking at validating these low- or so-called medium-risk claims. If you look, there is significantly lower risk in natural health products than in pharmaceutical products. I think I have alluded to that in previous testimony.

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

Mr. Volpe? That's it.

I'd like to ask a question, if I could. It has to do with the recommendations you're making for a third category. Since you discuss the Dietary Supplement Health and Education Act, I wonder whether or not a separate section of the existing act or a separate act that would allow for—we've used the word “appropriate”—evidence that would differentiate between those foods or herbal products that make a claim, rather than drugs.... And I understand that's what this does, although I am concerned, and this is the rest of the question: what if something doesn't make a claim? That's what concerned me when I saw the two products. Identical name, doesn't make a claim—are we concerned that it be on the shelf without a warning?

Does that question make sense?

Dr. William LaValley: Yes. If we go back to the natural health products advisory panel, there has been a long discussion about this. Products are widely available without claim. We need to recognize that there are still going to be products available without claim.

That's different from “without warning”, and it's also different from “without disclaimer”. What we're suggesting is that for anything that has evidence that warning is required, have warning, and that all of these have a disclaimer for whatever the claim is. Otherwise, if there's going to be a claim that's going to be assessed by Health Canada, then that product can't be available until that claim has been assessed as being valid. With the number of combinations of new products that are becoming available—and I had samples of those that I actually don't have here now. There are vast numbers of new combinations available that are going to be very difficult to validate through Health Canada's evidentiary basis.

The Vice-Chair (Ms. Elinor Caplan): Are you proposing a new and separate law when you talk about a separate category—

Dr. William LaValley: Yes.

The Vice-Chair (Ms. Elinor Caplan): —or are you saying that you could do it by an amendment to the existing legislation?

Dr. William LaValley: To me, an amendment to the legislation is a change to the legislation. So we are saying that there is necessary and required change to the legislation, with interim policy and appropriate coherent or supportive regulatory change in the meantime.

Dr. Lois Hare: We want people who understand natural therapeutics to be making those decisions, that it be well-educated people, not people that are—

The Vice-Chair (Ms. Elinor Caplan): To be clear, you're asking for expertise within Health Canada so that the judgments can be made by people who have expertise.

Dr. Lois Hare: That's right.

The Vice-Chair (Ms. Elinor Caplan): But you also want an alternative procedural process that will deal with issues such as claim, warning, disclaimer and information to the public that will protect the public, to ensure quality; and on the issue of accountability, your view is that they should be what they say they are.

Dr. Paul Saunders: Precisely. If the bottle says it's chromium picolinate and it's 200 micrograms, I want to know it's 200 micrograms. Somebody buying it over the counter needs to know that this is exactly what it is as well. Otherwise, it's not safe for our patients and it's not safe for the public.

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The Vice-Chair (Ms. Elinor Caplan): I'll keep the last question that I have short, because I know there are others who want to ask as well.

If you have two identical products, one that makes a claim and one that doesn't, do you think there should be a requirement that if there is one product that makes a claim, the one that doesn't make a claim should have to include the warning or disclaimer?

Dr. Lois Hare: Why not have the common use on the label?

A witness: Yes.

Ms. Carolyn Bennett (St. Paul's, Lib.): Actually, Elinor, that was my question. If you have two products next to one another on the shelf, and one is making a claim while the other one is not making a claim—it's the same as with the capitals—both require disclaimers. As a government—

Dr. Paul Saunders: Right.

Dr. William LaValley: What we're saying is that they all require disclaimers.

Ms. Carolyn Bennett: By association or by assumption, in some ways they're both making the same claim, even though it's not on the bottle.

Dr. Paul Saunders: In fact, it's hard to understand why a company wouldn't want to make a claim about its product. I look at that and I ask why a company wouldn't want to say chromium picolinate is part—

Dr. Lois Hare: It would make me question the product.

Dr. Paul Saunders: —of a glucose tolerance factor or something like that.

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

Ms. Aileen Carroll (Barrie—Simcoe—Bradford, Lib.): I'm just going to finish up here by getting to the basics. If you have decided it is a low risk, you've now eliminated the safety factor for all intents and purposes; so now we're then saying that it's basically buyer beware with regard to efficacy.

Dr. William LaValley: That's right. If you get very basic, that is the issue. Those products that are effective are therefore going to be the ones that survive in the long term. By orders of magnitude, the amount of cost and effort required to prove efficacy is far beyond the means available to this industry, whether it's in Canada or throughout the world, so it already is buyer beware.

The Vice-Chair (Ms. Elinor Caplan): Did you have one last comment that you wanted to make, Dr. Ania? We have about one minute left.

Ms. Aileen Carroll: I think Dr. Saunders wanted to say something.

The Vice-Chair (Ms. Elinor Caplan): I'm sorry, did you want to make a comment on that?

Dr. Paul Saunders: Yes.

Unfortunately, it is buyer beware now, and it's a buyer beware market in which the buyer does not have appropriate information. To go back to chromium picolinate, an individual should know what it's used for, what it's contraindicated for, what it's safe for, and when it's appropriate—and by the way, chromium picolinate is a very safe form in which to take chromium. So what we're saying is that we have the faculty and expertise to help Therapeutic Products Canada to make that determination.

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

The last point goes to Dr. Ania.

Dr. Fernando Ania:

[Editor's Note: Inaudible] Although the most commonly known technique uses remedies under dilution, we do have quite a range of remedies that must be prescribed or recommended on a botanical base...mother tincture, and one example is calendula. We do our...

[Editor's Note: Inaudible] ...on botanical medicine, and we have to base all our information on materia medica and homeopathic pharmacopoeia.

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

You're bursting, Ms. Carroll.

Ms. Aileen Carroll: With regard to what we're discussing being imported through mail order or 1-800 numbers, are you content that you would allow American products in to compete with you on the basis you have described?

Dr. William LaValley: They already are.

Dr. Lois Hare: It will sort itself out.

Ms. Aileen Carroll: But you're not suggesting any change.

Dr. William LaValley: What we're suggesting is to allow the Canadian manufacturers and distributors to make these products available themselves. Let them import them from these companies as commercial importers and without this onerous requirement that's going to jack up the costs, so that they can be available down in the pharmacies, down in the health food stores, down in the general stores, so that people can have greater access. Let people have access to the information about them, put the disclaimers on there, and let the market police itself.

Ms. Aileen Carroll: That's just what I'm saying: all of that done, let the market run.

Dr. William LaValley: Yes.

Dr. Paul Saunders: And one thing to add about the difficulty with patient access to a lot of these things is that some of those are, for example, things you can get on mail order, but we cannot get them in Canada in order to prescribe them, as naturopathic physicians or even medical physicians. For example, some of those things there are actually available in the States over the counter but they're not available to us to use in our practices. Chromium picolinate is an example of that.

Dr. William LaValley: Right, and some of us then recommend to people to call these 1-800 numbers in order to get them for themselves, because our concern is more for the patient's benefit than it is for bringing them in ourselves. If we bring them in ourselves, we're breaking the law. We therefore don't, but they still get them.

Dr. Lois Hare: While we're on that, at this point within the naturopathic profession and also in complementary medicine, there are professional groups that produce very high-quality, standardized products that we use as professionals but that are not available to the lay public. They're only allowed through professional use. We use those because we know they're standardized and we know they're quality-controlled. We want that for the general public, because they're going to be making their own health care decisions as well.

Ms. Aileen Carroll: All of this of course pertains to the totally low to medium risk.

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Dr. William LaValley: Less-than-high-risk products, that's correct.

The Vice-Chair (Ms. Elinor Caplan): I want to thank everyone for their participation today.

The committee will be meeting again tomorrow at 3.30 p.m. in this building, and I think in this room. Thank you all.

The committee stands adjourned.