HEAL Committee Meeting

STANDING COMMITTEE ON HEALTH

COMITÉ PERMANENT DE LA SANTÉ

EVIDENCE

[Recorded by Electronic Apparatus]

Wednesday, February 18, 1998

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[English]

The Chair (Ms. Beth Phinney (Hamilton Mountain, Lib.)): We have three groups with us today. This is our 19th meeting of the Standing Committee on Health. We're doing a study of natural health products. We have today witnesses from the Nonprescription Drug Manufacturers Association, from the Canadian Association of Chain Drug Stores, and from the National Association for Health Products.

We'll introduce just the main person from each one. For the Nonprescription Drug Manufacturers Association there's David Skinner. For the Canadian Association of Chain Drug Stores it's Ms. Mills.

Each group has between five and ten minutes. If you could keep it as short as possible...because most of the things you probably will want to say will come out from the members anyway, in their questioning. When you're answering their questions, they each get five minutes, and that's for your answers too. So they will probably ask you to keep your answers short, please, or to cut your answers short. They might have another question to ask in their five minutes.

We'll start with David Skinner, of the Nonprescription Drug Manufacturers Association. Do we have any literature from you?

Mr. David Skinner (President, Nonprescription Drug Manufacturers Association): Yes, I believe you have our brief.

The Chair: If any of you have any more literature to send in at another time, please send it to the clerk as soon as possible.

Fine. Go ahead.

Mr. David Skinner: Thank you, Madam Chairman.

First I would like to introduce my two compatriots. Dr. Natalie Lazarowych is from Ashbury. She has a great deal of technical knowledge in the area of herbal products. Brenda Watson is from Mead Johnson. She is going to provide back-up and some information on marketing impacts, international competitiveness, and issues related to marketing.

Our association now is over 100 years old. It has represented responsible self-medication throughout its history as one of Canada's oldest trade associations. Responsible self-medication has made a great impact on health care for the past 100 years, especially when it is considered that if only 10% of Canadians currently self-medicating were to see their doctor, the cost of medicare would double.

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Our mission is to contribute to an environment where self-care can make an even larger contribution to cost-effective health care. The review of natural health products is the opportunity to create a federal regulatory environment for such a future.

In preparing this submission we have consulted over 100 organizations representing manufacturers, government, pharmacy, and medicine. In addition, we have commissioned consumer research on over 20,000 Canadians concerning self-care.

On behalf of our members we invite the Standing Committee on Health to review the legislative and regulatory framework put forward in our presentation. This framework proposes a balanced approach to addressing consumer demands for access to a wide range of health products and providing assurances that these products are safe and of high quality and carry the necessary information to promote responsible use by Canadians. Although the proposed framework applies to all health products, the focus at this presentation will be on the application of the framework to products for self-care.

This framework recognizes that health products fall into a continuum of relative risk and that not all products carry the same level of risk, nor do all products require the same level of control. Regulatory requirements therefore should be based on the relative risk of products.

The current legislation divides products into foods and drugs. This proposal recommends that the term “drug” be replaced with the term “health product”, which encompasses a much wider range of products, whereas “drug” has been associated in consumers' minds with prescription drugs and illicit substances. We propose that health products should be divided into functional foods, natural health products, and pharmaceutical products. Health products in each of these categories would be further subdivided into either higher-risk or lower-risk for the purposes of federal review. All health products of similar risk would be subject to the same regulatory requirements for safety, quality, and permitted health claims.

Lower-risk products would be available for self-care purposes, and companies intending to market lower-risk health products would be permitted to use a notification system. Notification would involve attestation to a standard that could outline the safety and quality requirements as well as the appropriate label information for the product, including health claims. Only manufacturers with establishment licences would be permitted to use the notification system. Lower-risk health products without notification standards or manufacturers without establishment licences would be required to make a submission to the regulatory authority and market the product only after review and approval. Those using the notification system would notify the government within 30 days of first sale.

Functional foods, natural health products, and pharmaceutical products would be permitted to make structure, function, risk reduction, and treatment claims provided evidence supports such claims. Requirements for assessing the validity of health claims for lower-risk products need to be flexible. Regulatory authorities should rely on clinical data where available. However, product experience can also play a role in the evaluative process. Traditional references could be used to substantiate health claims for which traditional or folkloric use of the product is well documented. All published references would be accepted provided the publication is reputable and peer-reviewed.

Health products would also be permitted without claims. Health products without claims would fall under health product legislation and would be subject to the same regulatory requirements as other products with claims. In addition, health products without claims would require a disclaimer on the label indicating that no health claim had been approved for the product. Guidelines would need to be developed to ensure that label information and associated advertising did not imply unapproved health claims or content of active ingredients.

It is important that recommendations provide incentives for new research on health products. This framework proposes that proprietary data required by government for the regulation of health products should not be used to amend notification standards until three years after such a claim is approved. During this period, however, other manufacturers would be permitted to make similar claims but would be required to provide their own data for submissions.

In order for the proposed regulations on health claims to be permitted and to be effective, specific amendments are required to the current system. Schedule A and divisions IV and V of the regulations are indeed outdated and do not reflect the current scientific evidence. Section 30 of the Food and Drugs Act should be invoked in order that the recommendations proposed in this framework can be implemented in a timely fashion. This framework proposes that health products be regulated according to their relative risk. Sampling requirements should therefore also be based on the relative risk of the product.

As it stands, lower-risk products such as Trident gum and high-risk products such as Valium have the same sampling restrictions. It would be appropriate to remove the sampling prohibitions and replace them with guidelines and regulations which permit responsible sampling programs for lower-risk products.

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The recommendations put forth in our proposed framework aim to provide consumers with products that are safe and of high quality and that carry valid health claims with appropriate labelling. As well, the proposed framework provides more cost-effective and equitable methods for regulation of health products.

The current system is inadequate to meet these goals. Many non-prescription medications also have their origins in plant products, yet these medications are currently regulated as drugs. Metamucil, Vicks mentholyptus, Trident gum, and Senokot are all examples of lower-risk natural-source products which are currently regulated as drugs. In the current regulatory environment confusion and inequality are created by not recognizing that a great number of non-prescription products are based on natural substances. For example, natural health products are currently exempt from establishment licensing fees, yet competing products are often of similar or lower risk but are not exempt. The confusion and regulatory inequities which currently exist would be resolved by adoption of the framework described in our brief.

I would guess that each of you has already used two or more non-prescription products today, products such as Head and Shoulders or an anti-caries toothpaste. You might have used an antiperspirant or a mouthwash. They are all classified as drugs. I personally used six or seven today, including my echinacea, my quarter of an aspirin tablet, and several of these products here. Yet in many instances these products are considered of lower risk than some other products, and they are all regulated as drugs.

The current regulatory system is inadequate to deal effectively with the wide range of products available for self-care purposes. The proposed framework aims to do away with such discrepancies in the regulation of products for self-care by basing regulations on the relative risk of health products. Such a system will ensure that consumers are protected while appropriate and equitable regulatory measures are provided.

Thank you. We're prepared to answer any questions you may have.

The Chair: Thank you.

Now we have the Canadian Association of Chain Drug Stores. Ms. Mills.

Ms. Ellen Mary Mills (Vice President, Policy and Public Affairs, Canadian Association of Chain Drug Stores): Good afternoon, Madam Chairperson, honourable members, ladies and gentlemen. Our association sincerely appreciates the opportunity to present our views, and we appreciate being requested to come.

I too will try to keep it short. We have one advantage. We knew we were coming to speak to you during your third or fourth week of hearings. You probably have heard some of the things we will say. Also, having been behind the Nonprescription Drug Manufacturers, we will be saying some similar things.

There is a package. It may make it easier for me to skim through the presentation if you have it in front of you. We have included a Maclean's supplement which appeared in English in late October and in French in early December, because in it we did feature the natural health care products.

Let me begin by saying a tiny bit about our association. There is more information in the package.

We're a non-profit organization representing Canadian companies which own and operate pharmacies in a variety of retail outlets, whether those be what we think of as traditional drugstores, grocery stores, or department stores. We were established in 1989, but it is only since 1995 that we've had formal incorporation, with a full-time president, and since 1996 a full-time staff. Our main purpose is to ensure the viability of chain retail pharmacy, which provides Canadian consumers with convenient access to the widest range of products and professional health care services.

I won't go into the other statistics about our association. Our members currently fill 49% of the prescriptions across the country. There are a few other stats in there for you.

To begin I would like to make a few overview comments. Then I will go into a bit of the definition of the problem and what we see as a solution.

The first thing we would like to point out is that the explosive interest in and demand for these health care products is consumer driven. We think you need to keep that foremost in your mind and it needs to be looked at from that perspective.

There are stats in here which you've heard from other people. Over 56% of Canadians are using them. Over 76% of them are using them for their general well-being. Some 65% of them are buying these products in our pharmacies.

There's also information in here that shows you the magnitude of this demand in sales in the U.S. In 1997 the vitamin category, as it's called—vitamins, minerals, herbal supplements and homeopathic products—increased in sales dollars by 12.1%, but within that category, the herbal supplements increased by 37.6%, and within that, the emerging herbs, as we call them, increased by 106%.

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I think where the U.S. is, Canada is not far behind. It illustrates, again, that this is consumer driven. In finding any solution, I think we must look at it from that perspective.

The second perspective, from our point of view, and one of our main goals, is consumer safety. Consumers want quality products and they want correct information. In looking at solutions we have started from that premise.

Lastly, I'd like to point out that pharmacists make up one of the conventional health care professions that have responded to this consumer demand and have incorporated appropriate health care products into their pharmacy practice.

Our pharmacists on a daily basis are asked questions about these products as consumers are about to purchase them or ask about products they have read about or heard about and cannot purchase. It's partly a reflection of how pharmacists, on a year-to-year basis, are shown to be the most trusted profession. They're also seen to be the gateway to some of these products, particularly with seniors who are also taking medications. They look for pharmacists' advice on these products.

Lastly, CACDS's position is that we're trying to meld consumers' needs and interests with our professional views and the practices in chain retail pharmacy. We think it's time to not concentrate on personal biases, to not concentrate necessarily on professional perspectives solely, but to meld the two together and look at consumer interests. We are proposing what we hope is a reasoned and reasonable approach.

In the interests of time, I don't think I'll go through the reasons for the consumer-driven demand except to say that we do not think it is waning. We do not think it is something that will go away. We think it is something you need to face head on. There is some information here to back up our facts.

As well, I'd like to concentrate a little bit, before I get into solutions, on the chain retail pharmacies' response to date. Given the demand from consumers, I would say almost all our members carry vitamin supplements and herbal remedies. Homeopathics tend to be more in the traditional drugstore, but we have responded to consumers' needs and are stocking these.

Vitamins and supplements, within that entire category I was talking about, now dominate in terms of what the trade calls “number of SKUs”. On average, it's 295, and on average square footage, it's 62.4. But within that, the herbal remedies, although they have fewer items, are dominating the shelf space. That is an indication of the volume, the turnover and the demand for these products.

Our members have also responded with private-label products for a number of reasons. They do provide a lower-cost alternative, but also, given the regulatory framework and the problems with it, it allows our members to ensure quality for the products they're putting on their shelves. They're putting their name behind them, and customers look to those brands with some guarantee because they can take a recourse directly to the pharmacy involved.

Some of our members have gone the specialization route. Pharma Plus has a Health/Sense store north of Toronto that focuses on these products. They have another one in the Peterborough area.

Most of our members have involved our pharmacists in some training. They're either providing it themselves or taking advantage of training provided by suppliers who deal with pharmacies only. Swiss Herbals and Lawton's, for example, are asking all their pharmacists to go through training with the Canadian College of Naturopathic Medicine. They want to provide correct information to consumers.

Again, some of our members are putting together their own information for consumers. They have an advantage in that they're able to sort through the technical literature.

Finally, where some pharmacy practices are responding to this need—in Nova Scotia, for example, they have come up with guidelines for the sale of homeopathic products—our members are very much supporting those activities.

The problems? Without going into too much detail, I think you all know that consumer safety is jeopardized by the existing regulatory framework. If it is a food, no claims; if it's not a food, then it goes under the drug regime. The current system allows for very few claims.

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The current DIN system is not entirely effective in ensuring the quality of these products. It does not ensure that what is on the label is in the bottle. Botanical medicine is very complex. There is a great variety in the families of species. With regard to echinacea, which is one product on which tests have been conducted, they found that the label said it was echinacea augustifolia, but after testing found no echinacosides in it. Therefore they are assuming that it must be of a different variety. That's just one example.

Also, the good manufacturing practices are not entirely appropriate or are certainly not being entirely followed. With these particular products the raw materials have to be tested to ensure that the amounts of the properties are actually there. They need to be tested throughout the whole manufacturing process—before, during and after. These reports need to be filed with Health Canada or some body.

The lack of an effective regulatory system for these products has meant that the retailers have had to take measures on their own to ensure there is some sort of quality, because they are stocking these products. They are very careful in picking their suppliers. They ask for a great deal of information. In some cases, they do ask for some of the essaying reports. It just puts an extra burden on them. If there were a regulatory framework they could count on they wouldn't have this burden.

And the lack of enforcement of the regulatory regime, allowing illegal claims to be made by some parties, is creating a very un-level playing field. I was almost going to bring an example. A few weeks ago in Toronto, there was a flyer in the Toronto Star from a particular health food retailer who was making claims that are illegal under the current regime.

Let's go back to what the consumer wants. You've heard this before. The Canada Health Monitor survey has indicated that 86% to 94% of Canadians want regulation. Eighty-six percent definitely want to know the amount of the ingredient in the bottle. More importantly, I think, 87% want to know the purpose of the remedy, and under the current DIN system that is not always appropriate. They're not always available.

As an example, echinacea, again, has a DIN number; it says it's there for sore throats. Yet we all know about most of the literature and most of us are taking it because of flu symptoms or cold symptoms or are taking it as a preventative measure. Yet they are not allowed to say that because in applying for the DIN they must provide the scientific evidence from—quote—“two studies”, and the studies that are available deal only with sore throats. And because these things are not patentable a manufacturer is not going to engage in these very expensive and studies to prove the efficacy.

Lastly, consumers do want to know about safety and side effects. We have some guiding principles which I think flow from the problems. I'll run through these because they are why we came to our solutions. Again, our principles include quality products, the assurance that what is on the label is in the bottle, and safety for consumers. We think an individual has a right to chose his or her health care and a right to an informed choice. We think alternative medicine should be viewed as complementary to the conventional health care system. And we definitely want a level playing field for all manufacturers, distributors and retailers. Lastly, after looking at it from all the angles, we think there is a distinctiveness of natural products. In many cases they cannot be classed as food or should not be classed as a drug.

We think pharmacy has an opportunity or an advantage here because pharmacists, because of their formal training, both on ingredients and indications of prescription drugs, and their pharmacological principles, have a better understanding of how these natural products work, including how they work in the body, their harmful effects, and where they can fit into an individual's therapy. They have the technical resources to help individuals sift through the literature. Pharmacists see it as their duty to educate patients when they are asking about these properties and to instruct them in their proper use. Lastly, given their training and commitment to safeguarding patients' health, pharmacists can play a major role in ensuring whether the chosen product is appropriate for the individual patient or if the patient should see a doctor instead.

Our recommendations are grouped into three areas: the area pertaining to the product, the area pertaining to the consumer, and the area pertaining to the sale of these products.

Pertaining to the product, we do think there needs to be distinct and separate government legislation and regulation to cover these national health care products, to ensure specifically the identification of the correct species, not some distant cousin, and to standardize the dosage. We are talking here about potency, not efficacy. Where possible, we would like to see the minimum and maximum dosages indicated. With some of these things, more is not better, and some products currently on the market have more of the properties in the bottle than are found in the natural products in nature.

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We would like to see expiry date and shelf life on all products. At the moment, I believe that applies just to DIN products. We would like to see good manufacturing practices appropriate to natural products.

I think SA-ing techniques are perhaps not fully developed. You need to look at those practices, see whether they can fit the natural health care products, and then take into account that there is a variety of manufacturers, from very small to large.

Most importantly, we want the content of claims and advertising controlled, but we do believe labels should clearly indicate the purpose, or the traditional use, at least, for which this product has been used. It should also state the potential benefit. It can be worded as “may”, but we feel that consumers need to know what the possible benefit could be.

We also think they need to know the potential side effects, and clearly any warnings if there are specific conditions for which this natural health care product should not be used at all.

Pertaining to the consumer, we feel that the government should formally recognize the complementary role natural health care products can play within our health care system and the consumer's right to an informed choice about all the therapies available.

One suggestion we have is creating, in both print and the electronic media, a government-approved or -sanctioned source of information—on vitamins, minerals, supplements, herbals, botanical and homeopathic products—that is readily available to consumers. Whether it be on the Internet or in local libraries, it should be government sanctioned in the sense that you may not develop it individually. You would somehow sanction it to say that this is objective information, and the most current.

Flowing from that, then, we feel point-of-sale information and consumer advertising should be taken from that objective compendium. With an on-line system that could also be downloaded to patients while they're in the drugstore, if they want information about it. We feel that you'll never be able to regulate the Internet or information that comes from other sources, but consumers need to have objective information.

Lastly, we would like to see initiated a pre-approval process for consumer advertising of national health care products, similar to the recently introduced system for consumer drugs administered by the Advertising Standards of Canada. I sit on the advisory committee to that group. We feel that's necessary.

Our last set of recommendations pertains to the sale of products. The federal government should take action to ensure that natural health care products are made available to the consumer in the most effective and safe manner, first of all by establishing a streamlined approval process that's not unduly costly to facilitate the quick entry of these products to the Canadian market. We think whatever regime is created needs to be rigorously enforced to create a level playing field. As well, we feel that consumers should have access to retailers that have been formally trained in this area.

Obviously, we're suggesting that one option could be that this becomes part of pharmacists' formal training in their degree program at universities. This is not to say we're the only source where people can buy these things, but if consumers know that pharmacists have been fully trained in this area, and if they choose to go that source, they will get advice.

We feel there may be some consideration given for higher-risk products to be sold and released only behind the counter with some advice from a health care professional. Again, we're suggesting pharmacists. We think that could change, and we're not excluding other health care professionals, but....

Finally, I forgot to introduce my colleagues. They will be most helpful in answering questions, as they're the ones who are dealing with this on a daily basis. Sandra Aylward is from Lawton's, a chain down in Atlantic Canada, and Phil Rosenberg is from Hy & Zel's. Both are directors of pharmacy operations.

The Chair: Thank you very much.

From the National Association for Health Products, Monsieur Gagnon.

Mr. Pierre Morin (Counsellor, National Association for Health Products): Madame la présidente, I have a comment before Mr. Gagnon gets into it.

First, would the clerk be good enough to pass around one of each of these bottles? It's part of the presentation that's coming.

Second, I would like to apologize on behalf of Dr. Mockle, who couldn't make it. Quebec City had a major storm this morning and unfortunately he was detained. It's unfortunate, because he's also a member of the advisory panel on foods and nutraceuticals. So it's a link we have with us.

The Chair: Monsieur Gagnon.

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[Translation]

Mr. André Gagnon (Spokesperson, National Association for Health Products): Madam Chairman, honourable members, you have heard many presentations to date and all are stating the same basic situation. In Canada, the marketing of many natural health products is being restricted by the existing legislation and regulations that do not allow us to make claims even though we are able to demonstrate both the safety of these products and the validity of the claims.

Let us give you an everyday-life illustration of a typical situation.

[English]

You're going to receive two bottles, one with a red sticker, the other without. You also have this flyer.

Under current regulations one of these products is a food, the other should be a drug. Inside the bottle it's the same product. If you take the product with the red sticker.... During an inspection from the Canadian food agency inspections we were told to stop selling this product and change our label because we were not allowed to make such a claim for it as a food. Fine. The problem is we cannot make that claim for it as a drug either, because a reference to joints, “for the well-being of joints” is associated with arthritis. Since arthritis is part of schedule VIII, the claim is not allowed. We end up changing the label, removing the claim, and selling the product anyway, but as a food with no claim.

This illustrates the situation of many products on the market for which no health claim can be made, whether as a food or a drug. So when you hear the line from officials, well, just ask for a DIN if you want to make a claim, it means it is either very limited in scope or impossible to obtain. This is real life as we manufacturers have to live it.

Imagine our frustration. As this inspector is doing his job and at the same time we're struggling here with restrictive regulations, stretching the limits of legality, the U.S.A. is shipping into Canada illegal products under the same regulations because of a provision called “import for personal use”. In clear language it means Canadians can buy for their personal use products considered unsafe by the Canadian government, or not in conformity with regulations on labelling and advertising.

The sad truth about it is that in real life the Canadian government won't do much about it. This situation is not exaggerated. It is well documented. It shows how far apart we are from our U.S.A. neighbours.

We all recognize that safety is important. As a matter of fact, safety is not the key issue over here. In fact, the American Congress has recognized in a law known as DSHEA, which many of you have heard about, that dietary supplements are safe within a broad range of intake, and safety problems with the supplements are relatively rare. The same here in Canada. In real life we have enough history to prove there are very, very few safety problems with natural health products.

So for us safety is not the key issue. That does not mean it's not important, not a concern. It's just that we should not confuse safety with the risk concept. I think this is where the confusion comes.

[Translation]

One of the major concerns of Canadian officials and also of some of you is that even though a product may be safe, it can be a health hazard because someone could take an ineffective health product for a serious health problem, thus making his or her condition worse. This is probably a keystone of the whole issue.

The risk model involves many elements: safety, effectiveness, claim type and health problem concerned. But dealing with so many ingredients, you have to be careful not to spoil the cake, because many of the decisions that will have to be made later on, when developing a new regulatory framework, are based on the positions taken regarding the various elements of this famous risk model.

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Given that the analysis of these elements requires rigour and nuances, you are trapped if you take the easy way out, that is if you are overly cautious, as is the case right now. When things get too complex, you are careful, thus making it difficult to consider relaxing the regulations.

On the other hand, when you make a strict analysis of all those elements, you come to recognize that there would be no risk to public safety if many more health claims were permitted without having to go through a preapproval process and crushing red tape.

[English]

Finally, we don't think the status quo is an option. That has been well demonstrated.

Here are some of the recommendations we propose for the regulation of natural health products.

First, give a regulatory definition of natural health products. Then repeal schedule A. I think it's absolutely essential, as I've been saying over and over. If schedule A remains, we won't be further ahead even if we do everything else.

We also need to allow appropriate health claims. On this one, again, let's be honest. You can make structure and function claims on a lot of products, nutrient claims, which are not dangerous to life. If you take a product for energy, let's say, and it doesn't work, you'll stop using the product, so it won't put life in jeopardy. Let's not take the exception as a rule and say, for example, that a diabetic person will take the syrup instead of the normal medication for diabetes and will die.

First of all, self-treatment or self-diagnosis has been another story all along. Again, there has been a tendency to mix those concepts of self-diagnosis, self-treatment and usage of an OTC product. And again, let's be fair on this one: in most cases, a lot of natural health products address wellness promotion, prevention and risk reduction, so the part that concerns treatment concerns maybe 5% or 10% of the products. This is very important.

So that's our point about allowing for appropriate health claims.

Next, replace the current risk assessment model by the one proposed in our submission: lower-risk products and higher-risk products. Also, replace the current pre-market approval system by a notification system. Again, if we don't get through that pre-market approval system, we won't resolve the situation we have to deal with right now.

Finally, we should further discuss an appropriate structure for the regulation and management of natural health products.

[Translation]

We realize that this recommendation—the last one concerning an appropriate structure—involves many factors and many departments and also that it will need open and thorough discussions between all stakeholders. You cannot make those changes using a piecemeal approach.

I know there are a lot of questions about a third category, and then a fourth, a fifth, a sixth, etc. It goes on and on. There are homeopathic issues, Chinese medicine product issues, etc. The main thing is to look beyond categories and take a comprehensive view of the whole structure that appropriate experts will use to assess the claims put forward.

This doesn't necessarily mean creating a separate category every time, but rather have qualified people available in each particular discipline to give out specific information.

In closing, it must be remembered that there is an urgent need to take action, because as long as no changes are made to the regulatory framework, we will have to confront situations such as the one I explained to you at the beginning, and that kind of situation is getting to be unacceptable and will be less and less tolerated. I am a manufacturer and I have had to live with it daily for 20 years. Two years from now, if the problem is still not settled, there will be a growing sense of frustration. I'm not making any threats, I am simply stating a fact I have observed. The day-to-day marketing of our products is restricted and more and more we find it totally unacceptable.

Evidently, this issue is fairly new for you. Maybe that's why you do not feel this same sense of urgency. But for us, it is urgent to take action because we've always had to live with this problem. There has to be a clear political will to act expeditiously. I understand that with the way the existing system works, things start with the politicians' will, i.e. the Members of Parliament. We're counting on your helping the Canadian industry prosper in this high-growth sector. Thank you.

[English]

The Chair: Thank you very much. I'd like to thank all the groups. We're beginning to understand the situation and the problems and we appreciate your suggestions for where we can go with this.

And as I say, please keep your answers short. You're all going to want to say something for each question, so please be concise and help us with this problem. We have to come up with some conclusions, so we're looking for suggestions.

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Mr. Grant Hill.

Mr. Grant Hill (Macleod, Ref.): My thanks for your attendance as well.

To Mr. Skinner, first, on page VI of your presentation, the top paragraph, I'm not sure I understand this. It may be just that the wording needs clarification. Is this designed for a brand new product to come on the market and not be infringed upon by someone else by the standards changing?

Mr. David Skinner: Yes, this relates to the issue of effects above and beyond the traditional and classical and known effects. If we somehow find a manufacturer that is willing to invest some money to investigate further some new uses for an old product, the money they would spend to do that would not be wasted by, immediately upon making that submission and getting approval, their having all the competitors able to ride off with it on the basis of just amending the published standard. The concept is that you wouldn't amend the published standard so anybody could have access to that proprietary data until after three years. That would provide some incentive for people actually to do some research.

It doesn't lock anybody out of the market, of course, because it's not patent protection per se. It's simply saying that in new claim areas, within the first three years of that new claim you'll have to produce, if you're a competitor manufacturer, some similar data.

Mr. Grant Hill: Is any other country or jurisdiction doing that?

Mr. David Skinner: The U.S. does that, to a degree.

Mr. Grant Hill: For Ms. Mills, the traditional pharmacist is trained that there is a minimum-maximum dose for a product, that the active ingredient.... They can take blood levels and what not, and there's a real scientific basis to this. In homeopathy it's quite the reverse: infinitesimal quantities of product. I was surprised to hear you say the pharmacists are moving into that area, because the pharmacists I know are in fact quite skeptical about homeopathy.

Ms. Ellen Mary Mills: First, as I indicated, in this whole category all our members are into vitamins, supplements, and herbal product. I said it is certainly in the traditional drugstores where you find the prevalence of the homeopathic products. That is not to say they are in every drugstore, but in our survey of our members last year, the 1997 research we did, a number of them were carrying it. It tends to be a very individual choice at this stage on the homeopathic products.

I'm going to let my colleague answer a little further.

Mr. Phil Rosenberg (Canadian Association of Chain Drug Stores): I think what is happening is that companies out there are doing homeopathic medication. One that comes to mind is a company called Plant Dei in New Brunswick. They had proper DIN applications and DIN numbers for all their products. They do make claims, which is quite often allowed in homeopathic medication, but they are also running all kinds of seminars, training pharmacists, explaining how their products work and otherwise.

They are not necessarily the dilutions of the traditional homeopathic. When we say pharmacies are getting into homeopathic, “homeopathic” is becoming a very generic term. There are some large pharmacies in the Toronto area, and elsewhere in Canada, I'm sure, which call themselves homeopathic pharmacies, where the homeopathic inventory is probably less than 1% of the total store, but they call themselves “homeopathic”. It's becoming a recognized term. It appeals to the Europeans.

Mr. Grant Hill: I noticed in your recommendations that pharmacists should be better trained in this area. I also noticed that many of them are going out on their own and looking at.... We hear a number of other practitioners come in here and say “they are not nearly as well trained as we are; I have a four-year degree, it's specific to my field”, and what not. Do you see the training as substantially different from that for the traditional pharmacist?

Ms. Ellen Mary Mills: I would like to respond to that first.

We wrestled with this in putting forward that recommendation. It's based on looking at what I call the professional marketplace at present. At present, while there are naturopaths who have gone to a four-year degree and there are others who have done less, we want to make sure they are qualified, but we want that accountability to a licensing or regulatory body, which does not exist at the moment in those other designations. We feel that, at the moment, what gives the consumer the comfort with both pharmacists and physicians is the accountability to the licensing and regulatory body.

• 1620

If those other professions moved in that direction, fine. At the moment, because it's a very individual thing, we are saying there's an opportunity for pharmacists, if they do increase their training and it becomes mandatory within their degree in universities, to be seen as the preferred health care profession to give advice.

Mr. Grant Hill: Thank you.

The Chair: Madam Picard.

[Translation]

Ms. Pauline Picard (Drummond, BQ): I have no questions, Madam Chair. Like you, I'm beginning to understand the problems with the regulatory controls of those products.

[English]

The Chair: Ms. Caplan.

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

First, I'll be a bit parochial, if I may. Mr. Rosenberg's store is in my riding, and I was pleased to see it listed as Thornhill. It is the first time I've had a delegation directly from my riding, so this is kind of special for me—and I shop there.

Mr. Joseph Volpe (Eglinton—Lawrence, Lib.): But they have to give you samples.

Ms. Elinor Caplan: Oh, oh.

I stated earlier at this committee that I was speaking as a consumer as opposed to as an expert, so I have had some experience. It is very helpful for the committee to see the products as well as the advertising the delegation has brought forward today. We appreciate your making it that clear for us.

I've focused on four areas, the first being as a consumer. Perhaps one of the reasons consumers are requesting these kinds of products from their pharmacists when they go into drugstores is that they have an expectation that the pharmacist will know something about it. Because when they see a product in a bottle, they don't know if it's a food or a drug. In fact, if it's in a capsule and so forth the tendency is to look at it as a medication.

That's part of the confusion for this committee. We've been told that these are not drugs, that they are foods. Other people say, well, they are complementary products. The conclusion I'm coming to is that we need an alternative process for assessing those products—I see heads nodding—or an alternative method or procedure for processing those things that are foods and make a claim, or are herbal products and make a claim. What distinguishes them from other food products is that they don't make a claim.

Does anyone want to make a comment on that concept?

Mr. Pierre Morin: I want to clarify a point. I'm a consumer also, and I get very frustrated when I see on a bottle, “For therapeutic use”, and that's all. Which therapeutic use? What for?

Ms. Elinor Caplan: I think we agree that consumers want information. They also want to know that the product is safe. They assume that it's safe, because it wouldn't be on the shelf, just as bad foods and other products that are unsafe would be removed by Health Canada. There is an expectation of safety. There is an expectation of the quality of the product, either the process and how it was developed or that what's in the bottle is actually stated on the label.

Then there's the question on use. The problem we have is that because of the existing regime, consumers are being denied information that would be helpful to them in making choices.

Does anyone disagree with anything I have said so far?

[Translation]

Mr. André Aubé (Chairman, Regulatory Framework Committee, National Association for Health Products): First of all, I want to say that I am a pharmacist. Only one thing in your mind is not really clear, and it's the fact that, within the natural product category, there are not only food supplements but also, with all the scientific developments, products that are closer to drugs, that truly have medicating effects and that are indeed effective.

Let me give you an example. In Germany, when you are suffering from a depression, the preferred medication throughout the medical profession is a product called Saint-John's-wort. It is prescribed for 75% of cases of mild depression.

Therefore, we must keep in mind that some products are similar to food while others are similar to drugs. Presently, at least 30% of the population—earlier, I heard some figures that were even higher than those—, that is 10 million people, are using products for which it is hard to form a definite opinion because we have no notification, no clear claims.

• 1625

Whether the Canadian government and the Drugs Directorate like it or not, that is what is really happening. Therefore, we have no option but to make a decision now and to give people some clarifications so that they may make a choice. Action is urgently required because they will use those products regardless.

We have been waiting for a solution for years. I think that people are being denied truly effective products that are without side effects most of the time.

It is extremely important to keep this in mind. I believe these products should be available to people in a clear and precise context so that they will be able to form an opinion based on what is written on the label, on the quality of the product and on good manufacturing practices.

I wanted to make the distinction that within the whole range of natural products, some are closer to food and others are closer to drugs. Accordingly, they must be treated differently.

[English]

Ms. Elinor Caplan: Merci beaucoup. May I continue?

The Chair: Yes. Does anyone have a comment?

Mr. Phil Rosenberg: I have one thing to add to what André was saying when he mentioned St. John's wort, which is right now, I think, the number one seller in herbal products in Canada. I know it certainly is in our stores. We're selling tons of this product, and nowhere on those labels can you find the point that it causes sun sensitivity; if you go out in the sun between 11 a.m. and 3 p.m. you're in trouble. Nowhere does that appear, because you can't make claims, you can't talk about the product and what it's for.

I really think the compendium that we put forward in our presentation makes a lot of sense, so that there is sort of a standardized Bible, so to speak, of what the product's for, what the side effects are, and what the contraindications with medication are, which I could spend two hours talking about.

Ms. Elinor Caplan: The next point that I wanted to make as a consumer is this one: along with “is it safe?”, the other side of it is the point you raise, and that is, “is this going to harm me and what are the side effects?” This is part of the information that people need in order to make a good decision, but you also used the word “effective” and I think that's where we run into problems, if you will.

Here's my own thinking about this. People want to know if it's safe. They want to know what the side effects are. They want to know if the product is going to hurt them. They want the warnings. They want to know how toxic it is. They want to know if it should be controlled as a dangerous substance. They want to know if the product is a good quality one. But then they ask, “On the basis of efficacy, of effectiveness, how much evidence on something that is a low risk do I need the government to have before they'll let me try it and see if it works for me?”

I see a hand going up, and I'll let you answer, but I think that's the crux of this, because that's where it gets expensive for the consumer. The more research and the more evidence on effectiveness that you demand the more expensive it gets. I get a little nervous when you make the claim that something is effective. Then I say—and this is the question I've been asking everyone and it's a yes or a no answer I want—do you think that if a product makes a claim it should have to provide evidence appropriate to that claim, evidence that it does what it says it does?

The Chair: Mr. Gagnon.

Mr. André Gagnon: I also sell St. John's wort, and I know that I'm doing advertising, which is illegal. I know that and I don't care about saying it right now because that's real life. So everybody knows it and the authorities know it. St. John's wort has been advertised on TV and radio and in the newpapers. What am I going to do? Say nothing about it? No. That's the situation.

Secondly, to answer your question directly, that position we might tend to propose.... Depending on the degree of the claim, it's easily understandable that the degree of proof of efficacy of evidence would vary with regard to going from basic nutritional support claims to treatment claims. Here's a good example. Calcium is good for the bones. Everybody knows that. It's a biological fact. But if you want to say that calcium treats osteoporosis, you need more evidence. So I would say that until there is a structure and function claim you would probably need less evidence. Or let me put it the other way: treatment claims would require more evidence.

I would tend to propose that until structure and function claims the system of notification would have to be used even for treatment claims that are monographed. I know it's a bit of detail. What I'm saying is that we have to get out of the bureaucracy for approving health claims or approving evidence. There's no end to it. Afterwards, if you decide to say that sufficient evidence is needed then you get into the argument and the discussion of what sufficient evidence is. Who will decide—which doctor, which pharmacist, or whoever?

• 1630

So that's why I tend to look at the U.S. system. The bottom line is very few people are harmed by the products and they're making their choice with what is written on the label. We have to let free enterprise do its job here; otherwise we'll have more and more bureaucracy.

I'm not saying I want to deregulate totally. I'm just saying we should look into more assouplissement—I don't know the word in English—a little bit more deregulation, considering first safety and harm.

The Chair: Mr. Skinner.

Mr. David Skinner: I concur with André. You have to look at evidence. Definitely consumers want to know that the product is going to work. The Canadian government has always protected the consumer against fraud in many different consumer areas, and it's still a valid goal for government to do that.

Ms. Elinor Caplan: Let me jump in just for one second, if I could, Madam Chair.

You say they want to know if it's going to work. I'm a consumer. I'd like to try it and see if it works for me.

Mr. David Skinner: I'm not discounting that you as a consumer would like to have that. Take a look at page C-5 in our presentation. When you survey consumers, the number one thing they're looking for as a factor in choosing a product, at a ratio of three to one, is “What is the most effective product for my condition?”

Ms. Elinor Caplan: Let me say that as a consumer, I want to know, if there's no risk or if it's not going to hurt me, why shouldn't I be able to try it, even if all the evidence isn't there that it's necessarily going to work?

Mr. David Skinner: You have the right to do that anyway.

Ms. Elinor Caplan: No, I don't.

Mr. David Skinner: Yes, you do.

Mr. André Gagnon: As a food.

Mr. David Skinner: Or as an off-label use.

Ms. Elinor Caplan: Well, this is the issue. I don't have the information now. To be honest, I never heard of St. John's wort before I got here. I'm learning; sorry about that.

Mr. Pierre Morin: Go and see Phil.

Some hon. members: Oh, oh!

Ms. Elinor Caplan: We're hearing about things here today that you're saying are the biggest-selling products. Information and warnings are not on those labels. People don't have the information they need to make the decisions. So as a consumer, I'm challenging you to say, “I as a consumer am saying I want the freedom to choose, provided I have the information to make an informed choice, and I don't want the government interfering with my choice as long as I know the risk or that it's a low risk or no risk”.

Mr. David Skinner: I just wanted to finish off my point on that.

Consumers are assuming safety of the product that's on the market. What they're then looking for is a product that works, that delivers against the promises made. What you're saying is that you would like to be able to try something and see if it works or it doesn't. You can always do that. There's nothing in any system that would require you to stay away from a product because it's not on the label.

The number one-selling drug in the world I hold in my hand. We're talking about what kinds of clinical, multi-centre, multi-country, controlled trials you would have to do for that. Well, the fact of the matter is you shouldn't have to do that. You know it's eucalyptol or menthol. We've known about those things for a long time. It doesn't relieve you from the burden of actually knowing that it does something, versus having to have a whole hierarchy of clinical trials. That's the crux of it.

When people say you have to prove it works, they're thinking the only tool we can use to prove it is a clinical trial. What we're advocating is that there are many sources of information, and all we're asking is that you prevent what the current system allows, and that's somebody, let's say me, going out in my backyard next week, digging up whatever's in there, putting it in a capsule, and then selling it to you, hoping you'll use it to treat your diabetes or something.

There is a whole structure of risk that's not just based on safety, but on all of the other attendant factors—quality, efficacy, and all those things. It's not a simple matter, but I do believe that if you poll the consumers, everybody will say “I want to have the right to control my own body and my own health, but I'm looking for products that work. I'm not looking for products that are going to fail me.”

The Chair: Ms. Mills.

Ms. Ellen Mary Mills: Well, I may be saying some of the same things—

The Chair: Try not to.

Ms. Ellen Mary Mills: Okay.

The Chair: Just say what hasn't been said.

Ms. Ellen Mary Mills: All right.

Let me put it this way. The way we positioned it in here is that for some of the lower-risk products, if you want to call them that, traditional use that has been long-standing should be sufficient. For example, St. John's wort has been used for depression, and there's a long-standing history of it. This should be sufficient as long as it's coupled with the label showing its purpose as being of “potential” benefit, not “definite”.

• 1635

That's why we phrased it very carefully in here as “traditional” use and “potential” benefit. There should be a system that allows that to be approved quickly and easily and get it on the market for people to buy it.

Ms. Elinor Caplan: I've had—

The Chair: Thank you, Ms. Caplan. Mr. Myers.

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

Thank you to the three groups. I appreciate what you've been saying. I've learned a great deal.

Mr. Skinner, I was interested in page 11 of your proposal with respect to the further subdivision into either higher- or lower-risk health products. I wonder if you can outline that a little bit in terms of how that would be decided.

I notice you have eight factors listed. It's stated that there should be a significant match to those. I wondered if it has been quantified or looked into as to how you assess higher versus lower risk.

Mr. David Skinner: The system we're proposing is not dissimilar from virtually every other country in the world from the standpoint that health products are viewed initially as being lower risk unless they satisfy factors that would take them into a higher risk. It's not automatically assumed that everything that pops onto the market is of high risk and therefore has to be regulated to the nth degree.

You start off with an assumption that they're lower risk. Then, if you apply these factors and find that the predominance of these factors would say that there is a higher risk, you can deal with those differently. What we're talking about here is, what will government use in its assessment of the product for the purposes of putting it on the market? So it's a very simple screening technique.

Where there are standards already, it's not an issue. These things would generally apply to submissions that are new, novel, different, and you want to determine whether there is an existing product, whether there is a standard. All that would be easy. But where it's different and you want to assess whether it's of higher or lower risk, you could apply these factors.

You can't just pick any one of them, and satisfying one would throw you in, because in some cases that would capture water. You have to look at them as a predominance and actually use some judgment. That's where, when we get into the discussion of qualified personnel within the government departments that would administer this, they have to understand how to apply these.

Mr. Lynn Myers: That was my point. I was wondering how that would get to that kind of focus.

Ms. Mills, I was interested in what you were saying on page 12 with respect to the fact that just because it's a natural remedy it doesn't mean there are no side effects. The words “ineffective” and “dangerous” are used.

Do you have any examples of that? We've heard testimony from others that there are no problems in this area, and yet you suggest there are.

Ms. Ellen Mary Mills: Certainly my colleagues could speak to it, but echinacea, which we've all heard about, should not be used with any autoimmune diseases such as MS or arthritis. That clearly needs to be spelled out. At the moment, that is not something that is on any of the labels.

There are probably more examples.

Mr. Phil Rosenberg: The number-two-selling natural health remedy in Canada right now, after St. John's wort, is gingko baloba, which is contraindicated for anybody taking warfarin or ASA to thin their blood for heart purposes. It's actually contraindicated.

The Chair: What do you buy it for?

Mr. Phil Rosenberg: You buy it to improve your memory.

Mr. Lynn Myers: You could get some of that.

The Clerk of the Committee: I knew about it, but I forgot about it.

Some hon. members: Oh, oh.

Mr. Phil Rosenberg: There are other things like that.

Ms. Elinor Caplan: There are no warnings on those labels now?

Mr. Phil Rosenberg: No.

Ms. Elinor Caplan: You can't put a claim or a warning on?

Mr. Phil Rosenberg: No. Most of the warnings that occur on almost all these natural products—and it's to protect the butt of the manufacturer—say that it shouldn't be taken by pregnant women or nursing mothers. That's standard on most of the products.

There are just so many. Flaxseed, which a lot of people take—people have been taking it for a hundred years—can increase sugar levels in diabetics. People with diabetes can have their sugar level increased by taking flaxseed. There are an awful lot of seniors taking flaxseed every night, hoping it will regulate them.

Mr. Lynn Myers: Madam Chair, this is an important point. A few more want to answer this, and I'd like to hear from them.

The Chair: Who else wants to answer? Mr. Skinner.

Mr. David Skinner: As a general comment, in terms of the claim and whether it's a drug and you get the warnings, the loophole we have a problem with right now, if you care to call it a loophole, is that if you choose not to put the claim on it, then you don't fall under those same requirements to put the additional information on it. It's almost a catch-22.

• 1640

The difficulty is that everything has a balance of risk and benefit. What we're saying is that lower risks are highly skewed towards the benefit side, while there are some risks, and there might even be higher ones. I think of opium as a natural product. It's not necessarily in the lowest-risk category.

Dr. Lazarowych also may have some information of a general nature on this.

Dr. Natalie Lazarowych (Nonprescription Drug Manufacturers Association): There are hundreds of examples in the scientific literature, documenting a lot of the side effects. It's just a matter of people not being ignorant of them and the consumer getting information on the labels. Right here in front of me I have five publications, which list hundreds of different side effects for a multitude of different herbs.

Mr. David Skinner: If we can get this framework we're proposing in place, then it will allow for the proper information to reach the consumer. So these side effects we hear about...they will actually be aware of the possibilities. That can go a long way towards helping avoid those things, and that actually does improve the safety profile.

The Chair: Could you give copies of that to the clerk, so we could all get copies of it?

Ms. Ellen Mary Mills: That's why we were proposing a compendium, so consumers know where they can go for objective information, and once they have the information they may still want to discuss their particular situation with someone, so they need to know there's a health care professional who can do this, whoever is designated.

Mr. Lynn Myers: Madam Chair, I wanted to ask Mr. Gagnon....

On page 26 you speak about post-marketing surveillance, or “pharmaco-vigilance”. I wonder if you could explain that a little, please.

Mr. André Gagnon: I'll come to this one. Just one comment on what we just said about warnings about side effects: we all agree with that. It just has to be put in perspective. You may have side effects, but with 10 times the dosage.

This just expresses the fact that we need competent people out there to discuss this. I don't want to get into a debate, but yes, with St John's wort you can have some photosensitivity problems, but at 13 times the dosage. Again, it has to be put in perspective.

When I put my product on the market, I was aware of that. I read somewhere that it could interfere with other types of anti-depressant products. We asked experts. We asked Dr. Mockle to talk about it.

I just want to say we have to look at this as not being the problem. This could be accomplished, that part of it.

Next, your question about post-marketing surveillance. We say more effort has to be put into post-marketing surveillance than the pre-approval system. What assures consumers that they have quality products, well manufactured, is the post-surveillance. Right now, whether I have a DIN or not doesn't mean anything, because I can have my DIN application, I can have my number, and I can put anything in the bottle. That is why we say what is most important is post-marketing surveillance.

Mr. Lynn Myers: Who would do this, and how would it be done?

Mr. André Gagnon: It is done right now. It is done through the inspections. It just has to be discussed a little more in order to accomplish what we want.

Mr. Pierre Morin: A proposal by the therapeutic products program is currently on the table. It's to put in place a product licensing system, including, and mainly justified by, pharmaco-vigilance or post-marketing surveillance. Right now the only actual post-marketing surveillance in existence is adverse reaction reports.

Mr. Lynn Myers: You're broadening the scope, then. Is that what you're saying?

Mr. Pierre Morin: The idea is to broaden the scope, and to broaden it worldwide.

Mr. Lynn Myers: And Health Canada would do that?

Mr. Pierre Morin: Health Canada is currently proposing it.

Mr. Lynn Myers: I understand that, but in your scheme.

Mr. Pierre Morin: Oh, yes.

Mr. David Skinner: That also should be done on a relative risk basis. Certainly a new product, where we know nothing about the post-market surveillance aspects of it, would require reporting on a much more frequent basis. When you have a product that has been on the market for 100 years and you know plenty about it, only unexpectedly severe reports should be part of the scheme. That's the pharmaco-vigilance side, based on relative risk.

In addition to that, what André is talking about is the enforcement of the current law. When you look at the concerns that were raised earlier about illegal product on the market and the government throwing up its hands, saying it doesn't have the resources to enforce our current law, this proposal says okay, you will be shifting resources away from all this onerous pre-market and the stopping of people from getting on the market in a sensible way, and you will be freeing up some resources to allow you to go after those one or two bad players who are souring the whole system for everybody.

The Chair: Ms. Wasylycia-Leis.

Ms. Judy Wasylycia-Leis (Winnipeg North Centre, NDP): I'm sorry I didn't get the benefit of all the presentations. I will just pick up on what Ellen Mary Mills said.

• 1645

With your proposal, as outlined in the brief, any product making a claim would fall under this third category and would include with it notice of potential benefits and a warning of possible side effects and so on. For anything that doesn't make a claim, would you still leave it as a food? Are we saying that all products should fall under this category and should state on the label what they're intended to do, how they might help someone and what the side effects might be?

Ms. Ellen Mary Mills: We said there should be a separate and distinct category because we felt that under the current regime it's like you're trying to force-feed it into something it won't fit into. We didn't design it for you, but we're saying as it currently exists, it won't work. We think there needs to be something different, probably a distinct category.

But from the consumer perspective, I don't care what you call it, but if it falls into that category of supplements, herbs, vitamins and minerals, then they all should have on their labels what the traditional use is or wherever they got the evidence from. We're saying traditional use should be allowable, the purpose, the potential benefit. Yes, I think we'd like to see the products fall into that category.

You'd have to define it some way, and I think my colleagues here mentioned that earlier. You would have to define what falls into that category. Certainly we're not going to rope in a number of things that are clearly considered food.

The Chair: Mr. Gagnon.

Mr. André Gagnon: In fact, we're asking if natural health products without claims should be allowed on the market. I think we should be able to, for one reason: you're going to have information from other countries on other products anyway. Let's suppose you have a new product on the market. Of course you make sure that it's safe, not harmful and has warnings of possible side-effects—fine. Once this is done, why can't you have the right to sell that product even without a claim?

And if that's the case, right now the police should go into every pharmacy and take away the products without claims because they could be dangerous. You cannot take away the right of buying a product that is safe. Putting a claim on it is another matter. It's important and we want to do it.

But in the end, if you say that all products need a claim, depending on who will authorize that claim, you may end up.... Let's suppose that what comes out of this is that governments still have a big hand in it. We cannot make the claim. Does this mean we won't be able to sell that product without a claim, even if it's safe? No.

So you see, it depends on how the claim will be authorized and who will do it. I don't want to have the privilege of selling a product taken away from me. I'll leave the country. It's as simple as that.

The Chair: Mr. Skinner.

Mr. David Skinner: It's not an unrealistic expectation. Right now as we sit here, nitroglycerine, which is used for heart attack patients, does not have a claim on the label. There's nothing in the system we're proposing that says you still can't ensure—through the same standards and same levels of control—that the product is safe, that it's going to be out there and not harming people. You could still do it.

But you still have to satisfy the same requirements. Even in the pharmaceutical area there are products that are not required to have a claim on a label and arguably there are a lot of consumer products too. I don't know why they wouldn't put a claim on a label except for the fact that with the regulations now it's very difficult to do.

So if you should have the opportunity, then you as a marketer can choose to put it on or take it off. But if you're going to be on the shelf beside somebody who has put it on and you have to fulfil the same requirements, why wouldn't you put it on?

The Chair: Mr. Morin.

Mr. Pierre Morin: Let me just give you an example. The British herbal compendium says that garlic is very efficient in lowering cholesterol levels, but even if you applied for a claim in Canada for a DIN, you couldn't get it. It's schedule A, so you won't be able to say anything about it anyway. So you put garlic on the market. You have garlic as a food in pill form and people take it to lower their cholesterol levels. That's the consumer-driven market they were referring to a moment ago. But there's nothing on the label. You can't put anything on the label.

The Chair: Dr. Lazarowych.

Dr. Natalie Lazarowych: Let me use garlic as an example. In the literature there have been surveys of different garlic products. Some garlic products, for example, contain the equivalent of one five-hundredth of a clove of garlic, and they don't have any of the active components in them.

• 1650

Our company has looked at other products too, and we see this same diversity. People aren't making the link from all the products to the type of material that was used in the clinical trials. Hence there are no active components in there. If they can't show they have the active components in there, you shouldn't force them to make a claim, because obviously there's no expectation that their product would be effective.

So quality is an issue with the claims too.

Ms. Elinor Caplan: I would like to follow up on that idea. Personally, I don't like the term “third category”, because I think that suggests that within the existing Food and Drugs Act you can just shoehorn something in when it clearly doesn't fit. I think the concern consumers have is that if you try a third category, you are going to have the same standards for these other products, whether they are supplements or herbs or products that make a claim, and you'll apply the same standard as you do for drugs. I think that's a concern because of the cost. So I've been using an alternative assessment process, or alternative method of looking at them. Just as you have drugs and then you have over-the-counter drugs, you can have foods and then you can have natural products, which are products that make a claim.

I was interested in the comment about those things which don't make a claim. I wonder, from your experience, if you had two products on the shelf, one that made a claim, one that didn't make a claim, but they were identical, how would you deal with that in the new regime you are proposing? They have the same name on them, but one makes a claim, one doesn't. Under your proposal, what is the incentive actually to put the warning on?

[Translation]

Mr. André Aubé: I don't think it's a problem. As the gentleman was saying earlier, once the process has started, you will not find one single manufacturer who will not make the same claim as another manufacturer if both are putting on the shelves products with identical ingredients of the same quality. I don't think it's a problem at all.

Once you start the ball rolling, every supplier, every manufacturer will delight in making a claim as soon as all the required ingredients are in the bottle and it becomes possible to do it. Otherwise, he will be at a disadvantage.

I don't think you could find one who wouldn't do it, unless maybe for a six-month period. But once the system is in place, everyone will be able to make clear claims as to their product's use, its full qualities and everyone will do it without hesitation.

[English]

Ms. Elinor Caplan: That's my sense of it.

The Chair: Mr. Hill.

Mr. Grant Hill: Many of the people who use these products are anti-establishment. They are anti-physician, they are anti-pharmacist, they are against multinational drug companies. Many of them feel let down by those traditional groups, if you will. I've had a number of them say to me their biggest fear is that large drug companies, the medical profession, the pharmacists, will just scoop up this market; and it's a market they want to maintain for themselves. In other words, they look askance at my profession and in fact the pharmacists in this area.

How do you answer them when in Europe there is far less availability of product today, a very much tighter regulatory regime, and products are being handled by pharmacist-like individuals? How do you answer those individuals who fear more regulation rather than less?

Ms. Ellen Mary Mills: One of the first comments I would like to make is that the Canada Health Monitor Survey...of the 56% of people who had used one or more of these products—vitamins, minerals, herbals, supplements—in the last six months, 65% were buying them in a pharmacy. While I'm not going to discount what you are saying, I know when you had the Canada Health Food Association and the Coalition for Freedom of Choice, they used other statistics and turned them around, showing that because it was 30-something and they thought it was growing, that showed the confidence. I don't know. We could argue about that.

• 1655

I think there needs to be a number of retail outlets, but I go back to saying that I think the consumers need to get the information, first of all, and then they need to know that if they choose to talk to someone who is formally trained in this, they have some sources to go to. Some people may not—they may do their own homework and they may not want to trust a pharmacist or whatever—but that option should be there for people.

I'll let Phil add something.

Mr. Phil Rosenberg: If I can take it just one step further—and I do get out on the floor of the store, believe it or not—my answer to people of that nature, who may not want to trust the pharmacists or whatever, is I keep telling them that pharmacy is good for the natural products industry, because of the pharmacist being.... I think you used the term “gatekeeper” or “gatewatcher” or something in your presentation.

They are looking for standardized products. I'm not saying they should only use the active ingredient of a plant, because we know that in herbal medication quite often you have to use the whole plant and all the rest of it. We do enough reading by many of the key people in the industry to know it's a little bit different from a pharmaceutical product. That's well known.

But because the pharmacist has his reputation on the line, and his licence, by the way—he's accountable to a college of pharmacy in every province in the country—they want to make sure they have sufficient information and that the products they are selling are quality products and deliver what they hopefully would say on the labels.

That's the approach I use with anybody who's skeptical. As a matter of fact I write in one of the health bulletins, and that's one of the things I keep mentioning: let's work together, because a pharmacy is going to help you in the long run, get you a better product on the shelf.

I'm not saying the major clinical research is necessary if we can use the traditional, and in some cases it's almost anecdotal. If you can use traditional history of what some of these botanicals or these natural health products are for, then you're not going to put the small manufacturer out of business by forcing him to go to clinical trials that are going to cost him $300,000 and $400,000 for everything he wants to develop, and then the next day somebody is going to copy him and do the same thing.

I really think pharmacy will benefit, and that's the answer I use with these people: you're going to get a better quality of product.

The Chair: I'm not sure if I should say this or not, but I told the committee before that I was taking a couple of natural products for my cold a couple of weeks ago. The pharmacist was the one who said it would be okay to take echinacea and zinc and didn't give me any suggestion about the zinc, and I got very ill. Three people I've spoken to since, who are not pharmacists but who sell natural products and are trained in it, all told me I should have had zinc on a full stomach, and I wasn't told that by the pharmacist.

So there is truth in what you're saying, that more education is needed by the pharmacists.

Mr. Gagnon, did you want to respond to Mr. Hill's question?

[Translation]

Mr. André Aubé: I just want to remind you that I am a pharmacist and, therefore, my answer will probably come as a surprise to some of you.

[English]

The Chair: I thought Mr. Gagnon was going to answer.

Mr. André Gagnon: No, he's going to answer.

The Chair: Oh, okay.

[Translation]

Mr. André Aubé: Last year, in the United States, there were exactly 435 million prescriptions made by doctors and 475 million made by people who were not medical doctors but who practised alternative medicine. We must keep in mind that the European culture is not the same as the North American culture. I don't think that the people who practise alternative medicine will be playing a less active role in the near future. The truth is, there are more prescriptions made by alternative medicine practitioners than by officially recognized medical doctors in the U.S.

We have to keep this in mind, because it is a cultural difference. In my opinion, there is no reason to fear that all these people practising alternative medicine will go away.

Mr. André Gagnon: One more short comment. The groups we represent here today have a lot in common. I myself sell my products in pharmacies. However, we must be careful not to embark on a philosophical discussion. But there are some small irritants that I just cannot accept.

My father was a pioneer here. He worked for 50 years to try and expand the field of natural products. Excuse me, but it is not the pharmacists who developed that market; those daring pioneers did it, even though they were always seen as a fringe group.

I sell products in pharmacies. When one of my products is selling well, Jean Coutu copies it and puts it on the market. Excuse me, but you have to put things in perspective, without launching in a philosophical debate between pharmacists and naturopaths. You have to be careful about the nature of the product. Other than the fact that a product can be sold in a pharmacy, a health-food store or a grocery store, you have to wonder whether it is safe and whether it does have the effect claimed on the label. That is what an OTC product is all about.

• 1700

We are moving closer to a discussion on prescription drugs versus products sold through medical opinion. We must be careful to avoid this slippery slope.

[English]

The Chair: Ms. Ur.

Mrs. Rose-Marie Ur (Lambton—Kent—Middlesex, Lib.): Madam Chair, your statement was basically the question I was going to ask. I'm going to be, you may think, a little cynical, or a bit of a rebel asking this, but I'm going to ask it anyway.

Herbal drugs have been around for a long time. When did you all of a sudden get interested in the benefits of herbal products, and how long did it take for you to get interested? Did you watch the field where the little operations were satisfying an element that we wanted complementary medication with pharmaceutical medication? What inspired you to get really interested in this?

Ms. Ellen Mary Mills: I didn't get through my reasons for consumer-driven demand. Clearly, pharmacists traditionally have not been trained in these products. As I said, particularly when you're looking at the chain drugstores, you must remember pharmacists are the only health care professionals I can really think of, among the conventional ones, who are professional and who have to operate in a marketplace. When you have your customers coming in and asking you about these products and you're not working in a vacuum and you see what is happening around you in the U.S., certainly you begin to stock these products.

As I said, more and more of our members started to stock them. They have taken measures to put their pharmacists through training. You have independent pharmacists who have done that on their own.

It is a response to the consumer demand; it's as simple as that. If the consumer demand weren't there, I don't think the pharmacies would be stocking these and selling them.

Mrs. Rose-Marie Ur: But the consumer demand was being met through the small operations I have in my riding, where you have individuals who maybe have a room set up in their home or have a small business within a community and have been trained, or the individual who has an herb garden, a bit bigger than a regular garden, and sells these products.

The Canadian Association of Chain Drug Stores, in one of your recommendations, suggested we should ensure customers have easy access to retailers of natural health care products who have been formally trained in this area. As our Chairperson said, she went to one of these formally trained people and—

Ms. Ellen Mary Mills: No, let me respond. We are saying at the moment the pharmacists are not all formally trained. That's what our proposal is: that it should be mandatory within the pharmacy degree that's given by universities. But I am saying many of our members have gone out of our way... That is not to say they are fully trained in all aspects of it.

About your small provider-retailer, this whole demand for these products is like a big snowball. It keeps getting bigger and rolling. Certainly some of the people in your riding may have been going to little Mrs. Whatever, who had her shop at the side of her house, but this has been fuelled by the media, by our multicultural society, by many things, and it's like this big snowball. As customers came into the drugstores they began to ask about...

I think there was a smaller group of people who, as Mr. Hill is saying, for whatever reasons turned off on the establishment. They just happened to have that bent, in a sense. They always took more responsibility for their own well-being and health care and used these products. They may have come from Europe, from Germany, or whatever. But as it became more well known, as you got stories about these products in the media, and as current research is constantly going on in some areas, it's everything. It has mushroomed because of our emphasis on wellness. It is mushrooming because the boomers are more health conscious. They come into the drug stores and ask. And we started to sell them.

Dr. Natalie Lazarowych: I think what is at the root of this started in the 1980s. There were some clinical trials which showed some of these actually do work. That has legitimized them and it has been picked up by the media.

The Chair: Mrs. Ur, you're not getting a direct answer to your question, but maybe if you ask in a more direct way—

Mrs. Rose-Marie Ur: I'm getting what I thought I was going to get, though.

Mr. David Skinner: I was going to answer your question about what spurs this growth, what gets a lot of people interested in it.

• 1705

If you look at the data we provided in our brief, it talks about the size of the market now. The growth there has been phenomenal. It is a bit of a chicken-and-egg situation, with growth around 20% and more than 50% of the users less than two years into this market. So, yes, through the 1980s and up until even the last two years, the market demand was low.

I'll answer maybe part of your question, because I'm not a pharmacist and I'm not part of that, but I noticed particularly explosive growth when these products started to become more mainstream, when pharmacists started to stock them and so on.

When there was only a limited supply and a limited demand, all of that was happening in its own enclosed context. As soon as it started to move into the broader market, more people wanted to get in on the business, so to speak, and you ended up with a lot of people trying to get into the business.

And that is really the crux of where we are right now with the inequities in the system. There are opportunities now for somebody to just get in and make a quick buck on the backs of the consumers and get out, to make a million dollars in a couple of years and get out. It really doesn't matter what's going to happen because they're not going to be prosecuted.

But the people who are really interested in the long-term viability of this category and the contribution it can make to overall health care want to make it work, and you're seeing more and more of those kinds of consolidations within the small mom-and-pop stores. It's just the natural economy of the country.

The Chair: I'm just going to let Mr. Volpe ask his questions. If you wish, we can come back to this afterwards.

Mr. Volpe.

Mr. Joseph Volpe: I was going to ask a question about the relationships among pharmacists and the herbal products, herbalists, and naturopaths, and in the exchange I think you somewhat addressed that.

In one of our previous presentations, there was an exchange among some witnesses who said that under no circumstances should we allow.... No, perhaps I'm making that a little too strong. The witnesses said it's unfair to have people who are trained in pharmacy, for example, or in western medicine judge the efficacy of either the therapy or the product. In your responses you've already addressed that issue.

I guess one question that still isn't addressed in my own mind is the question of quality. You have these entrepreneurs coming on the market. They're producing something like this, or something analogous, something similar or something identical. And I'm one of those boomers now, like, “I'm really into this, I have to take some natural products”. How do I distinguish whether André Gagnon's product is as good as the Life brand? How do I tell the difference?

Mr. André Gagnon: It's the same as your shampoo, but, you know, that's not the right answer—

Voices: Oh, oh.

Mr. Joseph Volpe: In part it is.

Mr. André Gagnon: Part of the quality of the product—

Mr. Joseph Volpe: It depends on how much you use, I guess.

Mr. André Gagnon: First, how long you've been on the market makes a difference.

Mr. Joseph Volpe: We've just heard it's two years, that 50% of the people who are consumers haven't been using these products for more than two years.

Mr. André Gagnon: Yes, that's for the people, but the company has been there for longer.

Anyway, the straight answer to this is post-market surveillance. That's my answer. It can be accomplished.

Mr. Joseph Volpe: Let me tell you from the point of view of a victim and consumer. I've gone into my shops, my stores, since we've started this committee and I've been looking around to see who is producing this stuff. Shelf space assigned to these products in the local drug stores has literally ballooned. On a weekend I counted six different manufacturers, I think, and my memory is fading fast, but not fast enough—

The Chair: They have a drug for that.

Voices: Oh, oh.

The Chair: Not labelled.

Voices: Oh, oh.

Mr. Joseph Volpe: —to ignore the fact that just a year or a year and a half ago there was one manufacturer.

Mr. André Gagnon: Yes.

Mr. Joseph Volpe: Now all of those six are reputable people. They've all been on the market.... So which one of their products...? If I want to make a comparison, I can pick up an over-the-counter drug, read the list of ingredients and make my own decision. I used a product here, Sudafed, or Seldane or whatever it is. You can get the comparative stuff on what the ingredients are, and you can say that you want it or you don't. But I can't do that with this.

• 1710

Mr. Pierre Morin: Is the member using Sudafed a hockey player?

The Chair: He's banned.

Mr. Joseph Volpe: I'm a snowboarder.

Some hon. members: Oh, oh.

Mr. Pierre Morin: To answer your question, it's a book like this. I know the other group has been recommending a compendium. This is a compendium here. It's only for herbals. There should be one for all natural products. I don't think one exists at the moment for all natural products.

This tells you at least what is the minimum effective dosage. It tells you what the maximum dosage should be to be effective, or any side effects related to excessive dosage or whatever.

The problem is, you can't put it on the label. It has to stay in books. You can find this at your public library, or here at the parliamentary library. It makes for very interesting reading.

Mr. Joseph Volpe: But you know what I'm getting at.

Mr. Pierre Morin: Yes, I know what you're getting at.

Mr. Joseph Volpe: There's only one way that the regulator can ensure that the consumer is getting a quality product, whether it's labelled properly or not. It has to be an inspection on the site. You have to go there. You have to make sure all those things are done properly, etc.

Mr. Pierre Morin: The same as aspirin.

Mr. Joseph Volpe: The same as everything.

Mr. Pierre Morin: Yes, the same as everything.

Mr. Michel Sasseville (Biochemist and Member of the Board, National Association for Health Products): As a matter of fact, to be precise, you can get that type of information because HPB is already doing evaluations.

[Translation]

They make assessments and inspections in the manufacturers' facilities to make sure compliance is achieved.

People must know that in many cases, all natural products with a DIN, and even those that don't have one, are manufactured the same way and according to good manufacturing practices.

In this perspective, if the requirements go up a notch, you will necessarily find that those products will be more... If we could at least have information printed on the label, people would know exactly what they are taking. There would be no real safety risk.

We talked earlier about Saint-John's-wort and gingko as if they were the two most important products in Canada. Do you know that they are being used in Europe and that their effectiveness has been demonstrated? There were no reports of problems associated with their use.

This gentleman who is a pharmacist was saying earlier that Saint-John's-wort could have side effects for people taking blood thinners. If that information could appear on the label, it would be an improvement. But what this gentleman should also know because he is a pharmacist is that we have the same problems with food. For example, I am a biochemist and I have been working in this field for 20 years. I know that someone taking blood thinners can experience the same type of side effects when eating broccoli. Will pharmacists want to have regulations on broccoli sold in supermarkets?

But I think this is not the matter at issue. The real question is whether we are able to carry out adequate inspections of those products and I think that Health Canada inspectors are doing a good job.

However, we need to legislate the disclosure of all relevant information. We're not talking about making false claims, but of providing the information appearing in the compendiums.

It would be one way to not only make distribution more effective but to also meet your expectations. Thus, in theory at least, you would not have to wonder any more.

Maybe all seven products are very good. Maybe they are fine. Maybe it is those over-the-border products that are suspicious and that we should inspect.

At the moment, Health Canada will tell you that they are unable to do it.

[English]

The Chair: Merci. Mr. Skinner.

Mr. David Skinner: As I understand your question, you're curious about how you can tell which is of better quality, whether one is lousy and one is good quality. With the current system, the problem is, you can't tell by looking at the products. You could have a high-quality product and just leave the claim off and you're no longer a drug, so you're a food. Or you could have a really low-quality product, leave the claim off, and you're a food. You can't tell with the current system.

The most telling thing about your question is as it relates to efficacy. You want to know the best product, because you don't want to waste your money, right?

My wife is subject to migraines. She used one brand of feverfew—and I won't name brands—that helped prevent migraines for several months. She couldn't find that same brand the next time she went. She switched to another brand of feverfew. Her migraines came back immediately.

What's the difference in cost? Now she has to take Imitrex at $107 for six tablets, versus getting a month's worth of therapy for $14 as preventative care. That is the cost of failed efficacy.

• 1715

She finally could find the product that she originally started on, switched to that, and her migraine problem is under control. These are some of the things. But you could never tell that just looking from one competitor to another right now.

Dr. Natalie Lazarowych: In terms of quality, just picking up on the feverfew thing, there are I think at least 22 or 23 feverfew products on the market in Canada. Only two of them, when you do the chemical analysis of them, have the markers that link them to the clinical trial. The other 19-plus products don't have any link. They have no hope of being effective because they don't have the constituents that the feverfew used in the clinical trials did.

The only sure way to tell if you are getting a quality product really is the chemical testing and the microbiological testing. You can't tell just by looking at it. You have to have the testing there and you have to have compliance with some sorts of GMPs. If you don't have that, you're going to have more than 90% of the products not actually being efficacious, not being what they claim to the consumer.

Ms. Elinor Caplan: Would GMP standards for these types of products solve that problem?

Dr. Natalie Lazarowych: The herbal GMPs, if people actually followed them, if there was compliance, would go a long way to solving those problems.

Ms. Elinor Caplan: On the quality side.

Dr. Natalie Lazarowych: On the quality side, yes.

Mr. Pierre Morin: Post-marketing surveillance and also pharmacal vigilance. Post-marketing surveillance includes inspection, making sure that GMPs are being adhered to, compliance, and also seeing if there are any adverse effects being reported.

Mr. Joseph Volpe: You know there are departmental officials here taking notes.

The Chair: Then I'm changing them tomorrow.

Mr. David Skinner: The GMPs, by the way, are a very difficult thing to deal with, because right now—and perhaps Brenda has something to add on this—for a lot of these products, the differential between our GMPs and those of our major trading partners is costing Canada jobs. It's saying you cannot qualify a vendor of Calais, which is their calcium beverage.

Do you want to say something about this?

Ms. Brenda Watson (Mead Johnson Canada; Nonprescription Drug Manufacturers Association): Yes, absolutely. We come at it from somewhat of a different angle in that we are in the nutritional business. In the consumers we surveyed, the same sort of demand and need and want is there. However, they are saying, “Can you offer it in formats that fit my lifestyle somewhat better than the traditional pill or tablet format?”, which we see a lot of here today. In doing so, we automatically migrate to manufacturing facilities that are more in the food and beverage arena. In doing so, right away we have regulations that fit traditional pharmaceutical standards.

So the capital investment for us to participate in those fields is huge. It is very huge, to the point where we would much rather spend our dollars.... If you have $1 million to spend on a facility that is really over-regulated for the product need.... It is a beverage with calcium, in this case, a very simple, not-so-complex product that is now being regulated against pharmaceutical standards. If you have $1 million to spend, would you rather spend it on the education of the consumer to help them understand how that product can apply to their life, their lifestyle, and their quality of life, as opposed to on the manufacturing facility, which to a certain degree is overkill?

As we look at our U.S. partners, we see a very different set of rules. We are at the point, with some of the experiences we've had in Canada, where we have a tendency to move away from Canadian manufacturing for that reason. Either we will not participate in some of these opportunities, which I guess lets down Canadians in a big way, or we will seek alternatives in the U.S. as means to bring these products to market.

Those are two things that are not particularly positive for people trying to do business in Canada.

The Chair: We're past the time now. Is everybody okay?

Thank you very much for coming. You've been very helpful. If you have any other suggestions for what we can do, please send them in.

Mr. Pierre Morin: Madam Chair, could I just have a word?

The Chair: Yes.

Mr. Pierre Morin: If you look about midway through the brief, you'll find, in colour, a natural product sold in the U.S. that's used to lower cholesterol levels. It's the competitor to Merck's Mevacor. It's freely available in the U.S. over the counter, and it's available through mail order for Canadians.

• 1720

If you were told by your doctor that you had a high level of cholesterol and you inquired about the side effects of current medicines or drugs—and there are quite a few—and then you found this, what would be your reaction? To buy this, wouldn't it? It's a natural product with no side effects. It can't be sold in Canada. That's the point we're trying to make, or one of the points we're trying to make.

The Chair: Okay, thank you very much.

The meeting is adjourned to the call of the chair.