HEAL Committee Meeting

STANDING COMMITTEE ON HEALTH

COMITÉ PERMANENT DE LA SANTÉ

EVIDENCE

[Recorded by Electronic Apparatus]

Thursday, May 14, 1998

• 0929

[English]

The Chair (Ms. Beth Phinney (Hamilton Mountain, Lib.)): I call the meeting to order. We don't have video right now, but they have sound and I think we have sound, so we're going to carry on and hope that we will be able to pick up the video a little bit later.

Good morning, everybody. Pursuant to Standing Order 108(2), we are doing a study of natural health products.

• 0930

Within the context of that study, we have with us a panel of experts on international regulation. This round table discussion is scheduled to last until probably noon, and as we agreed, it will be televised.

We have received notice that Mr. Keith Martin would like to pursue his motion on organ transplantation. I requested that Mr. Martin raise this after the round table here this morning.

Following that, I would like also that members take a few minutes for the consideration of a budget submission for the continuation of our work on our natural health products study. Is this acceptable to the committee?

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

The Chair: I'd like to introduce our distinguished guests. We have a number of them here, and hopefully some over in Germany.

We have, from the Department of Health in the United Kingdom, Richard Woodfield, group manager of the Medicines Control Agency; and from Australia, Laurayne Bowler, acting director of the Chemicals and Non-Prescription Drug Branch.

We hope we have now—and if we don't, we will have in a few minutes—Dr. Konstantin Keller, director of the Federal Institute for Drugs and Medical Devices in Germany.

We also have with us again—and welcome back—the representatives from Health Canada: Dann Michols, director general, therapeutic products programme; Ron Burke, acting director, the bureau of food regulatory, international and interagency affairs, food directorate; Dr. Margaret Cheney, chief, nutrition evaluation division, food directorate; and Harry Conacher, acting director, bureau of chemical safety, food directorate.

We would ask that our two visitors from abroad begin.

The people from our Health Canada division will only be addressing us if we have a particular question for them. They will not be making a presentation, but you can ask them any questions you want.

Richard Woodfield, would you start, please.

Mr. Richard Woodfield (Group Manager, Medicines Control Agency, Department of Health (United Kingdom)): I'm grateful for the opportunity to participate in this meeting. Clearly, Canada is seeking to grapple with many of the same issues as we face in the United Kingdom and, more widely, in the European Union. Accordingly, it is very helpful to share experience and learn of the approaches that are under consideration in other countries.

It is important to be clear on the nature of the issues we face in the area of natural health products. There are certain features characteristic of this subject.

The market in natural health products of various kinds is growing in the United Kingdom, as elsewhere. Words such as “balanced”, “natural” and “holistic” currently carry very positive associations for the public, particularly at a time when there is increased awareness of the limitations of science and modern technology.

On a broad level, natural health products are correctly perceived as not presenting a major overall health problem relative to a number of other risks; however, “natural” does not necessarily equate to “safe”, and the Medicines Control Agency and other relevant U.K agencies perceive the need to remain vigilant where there are specific risks.

It remains persistently difficult to encapsulate many natural products neatly within particular categories such as medicine, food or cosmetic. Terms such as “nutraceutical” and “cosmeceutical” have been used by some to try to encapsulate some of these products of indeterminate or hybrid status. Even where a product is satisfactorily categorized, a very small change in labelling or ingredients may be sufficient to change the status of the products in the United Kingdom.

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There are a wide variety of traditions and current practices across the European Union. Key words and phrases in the relevant directives are liable to different interpretation by the regulatory authorities and courts in each country. Any regulatory regime needs to recognize that we're dealing with a wide range of activities, ranging from major companies operating in a number of countries to individual herbal practitioners using raw herbs to make up traditional remedies for individual patients.

It may be helpful if I focus briefly on some of the issues facing the U.K. at a domestic level and within Europe. I hope you will understand if I concentrate mainly on aspects relating to medicinal products, as this is the responsibility of the Medicines Control Agency, for whom I work.

To illustrate the nature of our work, in the MCA—the Medicines Control Agency—we have a borderline section that handles the classification of products that are on the borderline of medicines and food or of medicines and cosmetics. Manufacturers and retailers of such borderline products face an interesting decision as to how they present and market a product. If a product is medicinal by function or medicinal by presentation, then under European Community and United Kingdom law it must be treated as a medicine. However, what is medicinal by presentation?

The dividing line between a health maintenance claim, where a product can be treated as a food, and a medicinal claim, where the product must be treated as a medicine, is very difficult to define with clarity. This applies particularly where claims are implied or indirect. Not surprisingly, one finds that there are some linguistic experts within the industry who seek to probe and find out how far the boundary can extend in the desired direction.

Once a product is classified as medicine, there is then a question of whether it is subject to licensing or market authorization requirements. EC directives give scope to exempt from the normal market authorization requirements where the product is not industrially produced. This provision is well used within the United Kingdom in relation to herbal medicines, reflecting the long tradition of herbal practice in our country.

The U.K. exemptions are subject to certain conditions set out in law. For example, no claims are allowed, and if they are to benefit from the exemption, herbal remedies on general retail sale may only be made from simple processes. But, in general, exempt herbal remedies in the United Kingdom are subject to relatively few constraints.

The overall effect of the arrangements I have just described is that if a herbal product is classified as a medicine, then in principle it is subject to the requirements of the medicine's law, which are more stringent than those of the food law. However, if the product, although a medicine, qualifies for exemption from market authorization requirements, it is then subject to requirements that are less onerous than those relating either to licensed medicines or to foods. In part, this pragmatic arrangement reflects the importance that has traditionally been attached to preservation of a wide range of choice for the public.

What might be characterized as the all-or-nothing nature of the herbal medicines provisions has led to a number of suggestions for a halfway house for herbal medicines. There have been calls variously for some form of registration, or soft licensing system, possibly associated with positive or negative lists of permitted herbs and/or limited claims for limited indications.

One possible model that has been floated is that of the European Community homeopathic registration scheme. This scheme deals with safety and quality issues but not efficacy, and accordingly no claims are allowed.

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The early operation of this scheme suggests that it is a reasonably practical way of providing an appropriate but not unnecessarily onerous level of regulation for this particular type of product, but homeopathic medicines are of course by no means analogous with herbal medicines, so a direct translation of this scheme might not be appropriate.

You may well be aware of the work in progress in Europe that may in time lead to a range of developments on the herbal front. These include the ad hoc working group, ably chaired by Dr. Keller of Germany, which is looking in particular at ways of improving the handling of mutual recognition of licensed herbal products within the European Union.

There is also a study being mounted by the European Commission to compare the various arrangements used for regulating herbal remedies in the different member states. This latter work could eventually lead to proposals for a new regime for herbal medicines in the European Union. Unfortunately, for the purposes of the current Canadian study, I think it is too early to make any reliable prediction of whether there will be such a new European Union regime, and if so, when it will come into force, and what are likely to be its main features.

The possibility that the European Union may in time agree to new arrangements for herbal medicines makes it fairly unlikely that there will be any fundamental changes in the foreseeable future in the operation of what we call the “herbal exemptions” in the United Kingdom. However, to the extent that any adjustments may be needed to update provisions, the Medicines Control Agency would seek to evaluate the possible case for change against the following factors.

The overriding consideration would be protection of public health while also taking into account the need for proportionality to risk, the desirability of maintaining choice for the public and practitioners, and the desirability of avoiding overregulation.

I should note that this emphasis on protecting public health is intentional. This aim features prominently within the Medicines Control Agency's overall remit, and it will also be the overriding priority of the new food standards agency the U.K. government plans to set up, possibly as soon as 1999, subject to the passage of the necessary legislation.

We also wait on European Union developments in the important area of vitamins and mineral supplements, where there is of course a substantial and growing market in the United Kingdom and other EU member states. Whether such products are classified as food depends on their presentation, and in some cases their strength.

There have been concerns about the lack of harmonization across the European Union and the number of trade disputes arising from this. The U.K. operates a relatively liberal regime compared with some other member states. A discussion document was issued by the European Commission in 1997, but it is not yet clear whether, or when, specific proposals will emerge.

The U.K.'s general position is to argue that any proposals for harmonization should be driven by public safety considerations. Some other countries favour an approach based on need, typically using a multiple of a recommended daily allowance, which is an approach that tends to imply lower limits than if safety is the key consideration.

One other development in the United Kingdom is the setting up of an ad hoc expert group on vitamins and minerals. This will establish principles on which controls for ensuring the safety of vitamins and mineral supplements sold under the food law can be based. It will review the levels of individual vitamins and minerals associated with adverse affects, and will recommend maximum intakes of vitamins and minerals from supplements, if appropriate.

In conclusion, such is the range and complexity of the products and issues covered by the term “natural health products” that it does seem relatively unlikely that there will be any form of big bang reforms in the United Kingdom or the European Union that would cover the full range of these issues.

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What is perhaps more likely is that over a period there will be incremental initiatives and proposals designed to focus on particular problem areas where action merits priority to clarify the nature of the boundaries between the various categories of products and to gradually bring great coherence to the totality of the regulatory provisions. An example of such a specific initiative within the United Kingdom is the joint health claims initiative in progress between industry, consumer groups, and the relative government agencies.

From the wider EU perspective, there will be a balance to be struck on whether further EU harmonization is feasible and where it makes sense to retain flexibilities for individual countries to reflect their particular circumstances.

Thank you.

The Chair: Thank you very much, Mr. Woodfield.

Now we'll ask for Laurayne Bowler from Australia.

Ms. Laurayne Bowler (Acting Director, Chemicals and Non-Prescription Drug Branch (Australia)): Thank you, Madam Chair.

I'm very grateful for the opportunity to come and share our experiences with you today and also to learn from others what is going on in the rest of the world. It is a growing area and an area that requires a lot of debate and a lot of sensitivity to the issues that are involved, so that we don't overregulate the industry and we ensure that consumers have access to all the products they wish to have access to, provided they are safe.

In Australia, since 1991, when the Therapeutic Goods Act came into operation, we have regulated all therapeutic goods. We have a national system of controls that relates to the safety, quality, efficacy, and the timely availability of all therapeutic goods imported, exported, manufactured, and supplied in Australia. All goods must be included in our register, with very few exceptions, before they can be supplied to or exported from Australia.

The act does not specifically distinguish between orthodox medicines and natural medicines, but regulates medicines according to a general risk category into which they fall. Thus, the act provides a high degree of scrutiny for products of the high-risk category, while the way to regulatory intervention is less for lower-risk products about which safety concerns are not so great.

This risk management strategy has two arms: we have pre-market assessment, or evaluation, and post-market monitoring. In the pre-market assessment the act sets up a two-tier system: those goods that must be registered on an Australian register of therapeutic goods and those that are listed. Administratively, we have also subdivided the registered category into two levels of evaluation, depending on the perceived risk. In general, the risk is assessed on the basis of the active ingredients in the product. However, there may be other criteria, such as the need for sterility, or the product may belong to a category, such as blood products or radio-pharmaceuticals, or it may be for an indication, such as oral rehydration in infants, that determines the level of risk that needs some evaluation.

Thus, prescription drugs receive the greatest level of regulatory weight and pre-market assessment. Sponsors of these products are required to provide extensive clinical, chemical, and toxicological data to establish their safety, quality, and efficacy. The data for these products are the same or similar to those required in other countries.

For non-prescription products, which are not listable, and that's the lower level of that registration category I mentioned, a full evaluation of the product is undertaken. However, as these products contain substances that generally have a well-established history of use, including a profile of potential safety concerns and therapeutic benefits, the level of data that sponsors are required to submit is considerably less than for new prescription products.

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The therapeutic claims that can be made for these products are also limited generally to the relief of symptoms or the treatment of minor self-limiting conditions. However, if there is evidence that supports other claims, these products may also be allowed to make those claims, but in such cases they will need to seek exemptions to make those to the public, either on the labels or in advertisements.

The listed category is proscribed. That is, only certain categories of substances may be permitted in listed products, and these are predetermined and set out in our legislation. These include most but not all herbal medicines, vitamins, minerals, homeopathic medicines, sunscreens, amino acids and certain other substances such as fish oils, methylcellulose and pectin.

As with the non-prescription medicines that are registered, the claims these medicines can make are also another factor that controls their safety. They make only make claims for the treating of the symptoms or minor self-limiting conditions. For these medicines there is no ability for them to seek exemptions to make wider claims.

Where listable products comply with these restrictions, we have adopted a high level of co-regulation, with sponsors providing basic data in relation to their product through an electronic lodgement facility for entry onto the register, and making a declaration that the product complies with all the relevant standards and requirements of the legislation.

We have preliminary post-market checks, however, that we carry out immediately after the product has been entered on the register, to verify the safety claim for those elements that cannot be electronically checked. These include checks on the eligibility of the ingredients, the indications for which the product is marketed, and that the product will carry the required warnings. Both the electronic lodgement and the preliminary checks are carried out within 20 working days. Products that do not pass these tests are not entered onto the register or are cancelled.

As I mentioned, substances that are contained in lists of products are proscribed. The regulations, however, as we currently have, them make it fairly difficult to include new substances in that proscribed list. There is no specific provision for including new herbal substances, although administratively we have set up a committee, called the Traditional Medicines Evaluation Committee, to provide advice in relation to new herbal substances. However, very few applications have been received. This is largely because these products are not patentable, and no company seems to be prepared to put up an application.

For new chemical entities, there is only one route of assessment at the moment, and that is through the same level as prescription drugs. In 1996 a review of the TGA recommended we should adopt a more flexible approach. In response to that recommendation, a new committee has been established. It is called the Complementary Medicines Evaluation Committee, and it will look at all these products such as nutraceuticals, herbal medicines and those with the food-drug interface, and advise on how these may be assessed. At the moment they have adopted a more flexible approach to the data requirements and are prepared to look at complementary use and traditional use in evaluating the safety of the ingredients. The committee at this stage has met only four times but has already approved six new substances.

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Part of the evaluation of new products, as I mentioned, is listable claims or claims for minor, self-limiting conditions. These claims are related to our therapeutic goods advertising code and what is permitted within the confines of that code. The code is developed in a co-regulatory approach through a committee, the Therapeutic Goods Advertising Code Council, which comprises industry, professionals, consumers, and regulatory agencies.

As I mentioned, we have a number of pre-marketing and post-marketing checks. Part of the post-marketing monitoring of our products includes GMP inspections to make sure that products continue to comply with the requirements of good manufacturing practice. Therapeutic goods laboratories undertake a sampling program targeted mainly at high-risk products or those where we have information that indicates there may be some particular problem.

The monitoring of adverse reactions is also an important element in our post-market monitoring program. Sponsors are required to report any adverse effects, and health professionals are encouraged to report full details of adverse reactions in their patients. We are currently seeking to encourage health professionals in the natural and traditional medicines area to report such reactions.

As I mentioned earlier, we have a preliminary check of listed products, but we also undertake a full check of a random sample of these applications to ensure compliance with the legislation.

Another aspect of our post-marketing is the pre-clearance of advertisements and the handling of complaints about advertisements. This is also done in a co-regulatory manner, with the functions largely being delegated to industry associations.

In conclusion, it's been accepted by consumers and industry that government generally has a responsibility to protect public health and safety. It also needs to ensure that the general public is not unreasonably denied access to medicines they need. The issue is really one of balance. As the community's knowledge of health matters and medicines grows, so too does their ability to make informed choices about health care, including the use of a wider range of medicines. The Australian regulatory system endeavours to recognize this and regularly reviews our controls to seek to ensure that the regulations continue to protect public health and safety without unnecessarily restricting public access.

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

I'm pleased to tell the committee that we think we have contacted Germany. I'm going to introduce Dr. Keller, who is with the Federal Institute for Drugs and Medical Devices in Germany.

Can you hear me, Dr. Keller?

Dr. Konstantin Keller (Director, Federal Institute for Drugs and Medical Devices (Germany)): Thank you. The sound is not excellent, but I can hear you. I didn't hear the start of your conference, so I'm not quite sure if I should start by giving you a very brief presentation on our institute and the situation in Germany....

The Vice-Chair (Ms. Elinor Caplan): So far we've had presentations from England and Australia. The committee has not begun questioning, so I'll tell you what we'll do. We'll make a commitment to send you the transcripts of the two presentations we've heard, but we'd like to hear from you about the situation in Germany today. Then we'll begin our questioning. If that's acceptable to you, please begin your presentation.

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Dr. Konstantin Keller: Yes, I have prepared a very brief presentation on the situation in Germany. First of all I want to introduce the Federal Institute for Drugs and Medical Devices, which is responsible for the assessment of medicinal products on the German market, pharmacovigilance and narcotic products.

The institute is not responsible for the assessment of food and food supplements, but as you will see, in Germany some of these products you are speaking about are considered drugs. As director and professor at this institute, I am responsible for the department of alternative medicines in our institute. So the German situation is that preparations that are presented for treating and preventing disease in human beings or animals, or that may be administered with a view to correcting or modifying physiological functions, are medicinal products as defined in article 1 of the European Council directive 65/65, and in article 2 of the German Medicines Act.

Foods are defined in Germany to be substances that are presented for consumption by eating or breaking. So most herbal or homoeopathic medicinal products are neither foods, because they do not have any nutritional value or pleasant taste, nor cosmetics. Minerals can be found in those categories; however, it's not allowed to present the same product as a food and as a medicinal product. The classification is based on the dosage, on how the product is presented to the public, and on the conception the public has of the product. There is a counteractive jurisdiction on such classification issues in Germany.

So the German Medicines Act and the council directive 65/65 of the European Economic Community apply fully to all medicinal products. This was confirmed at the European Court of Justice in 1992.

A marketing authorization is necessary and has to be granted by the competent authorities. The applicant has to document quality, safety and efficacy of those medicinal products. The drugs are included in the German and European pharmacopoeia, and specific aspects of quality control of herbal remedies are described in different European directives and guidelines.

The criteria for the evaluation of safety and efficacy apply to those medicinal products in the same way as they apply to all other medicinal products with comparable indications. However, the regulation ensures that the complex composition of herbal active ingredients has to be taken into account, and because herbal medicinal products can rely on the long-term use and experience, bibliographic data on safety and efficacy can used in the assessment. So it's not necessary to repeat all the trials and tests for well-established herbal medicinal products.

It's evident that homeopathy is well established in Germany, because it was established about 200 years ago by the German doctor, Samuel Hahnemann. Following an extremely controversial debate in Germany, our Parliament decided in 1976 to support pluralism in therapy, allow different schools of therapy, and include specific regulations on homeopathic products in our Medicines Act from 1976.

On the European level, regulations related to homoeopathic preparations were introduced by the European Union in 1992 and by the European pharmacopoeia in 1996. Homeopathic medicinal products are medicinal products as defined in article 1 of European Council directive, and so again the legal and terminological framework for homeopathic medicinal products in Germany and in the European Union is laid down in this legislation.

We think the strict control of the safety of homeopathic medicinal products is necessary because they may present risks, and many homeopathic products on the German market have been subject to pharmacovigilance action and have had to be withdrawn from the market for safety reasons. We think homeopathic medicinal products should be included in pharmacovigilance systems as well. However, the requirements for safety and efficacy should not be applied in a way that might discriminate against this particular area of therapy. We think the requirements for homeopathic and for herbal medicinal products should be adequate and proportionate.

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The partial lack of modern studies in this area should not prevent agencies from investigating the national market of homeopathic and herbal medicinal products, and we have had the experience now for nearly 20 years that there is the need to protect public health in this area. We think the best way to protect public health from risks associated with herbal and homeopathic medicinal products is to make well-tested and adequately labelled products available to the public.

I would like to stop at this point, because I think we can still go through the different questions you have sent to me and we could address particular problems in the discussion later on, if you want.

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

We'll begin now with questions from the committee. Mr. Elley.

Mr. Reed Elley: Thank you very much, Madam Chair. At the outset I would like to thank very much, on behalf of myself and the committee, those who have come from afar to our country and have joined us here in person today, and Dr. Keller, who's joining us through the teleconference.

One of the decisions we will have to make in this country at the end of the day concerns whether or not we will have to set up a separate regulatory body to handle therapeutic products or whether we can do it under existing framework within the health protection branch of Health Canada.

I'm wondering, from your experiences, once you settled this issue—it's never settled, I guess, but as much as possible—did you have to create a whole new bureaucracy for this? Of course, people are very concerned about that in terms of cost and this sort of thing. Could the three of you briefly share your experience from that aspect?

Perhaps we'll start with our friend from Australia.

Ms. Laurayne Bowler: I'd be happy to answer that question. We have had to obviously put on staff to evaluate where that is necessary. As I said, there are a few of these herbal, natural, whatever you want to call them, medicines that have not been included in our listed category, so they need to be evaluated. But their evaluation generally does not take an enormous amount of resources, and certainly has not taken a considerable amount of resources to date. I'll come back to that in a moment.

The listed products, because it's a simplified listing system and particularly since we have introduced the electronic processing, go through fairly quickly. The main resources are now channelled into our post-market monitoring in that area.

Since we had the review in 1996 that looked at the problems of actually getting new substances onto the market and how we might go about that, we have needed to increase our staff for two reasons. One is to actually evaluate material that is available; but also, because these are not patentable, we are finding industry is not prepared to put up and undertake the research that is necessary in some of these areas. So we are finding that our staff is actually doing the research, which is largely literature-based. It is not clinical studies. It is a literature-based search and a toxicological assessment of the information that is available, mainly in the public arena, and some that is submitted by the companies. We're in a state of flux in developing this, so we're not quite sure how much work will be involved and how successful that will be.

We will need to look at how we can cost recover. As of July 1, Australia will be moving towards a full cost recovery from industry, so we will need to look at how the resources that are devoted to that will be recovered.

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In some ways, it may well be cheaper for industry in that if they have to do the research and we then re-evaluate it, there's a double cost. If it is actually done by the TGA, that may in fact be cheaper overall for industry. Industry, of course, even when the TGA is doing these reviews, is invited to comment, to put in submissions, and those submissions are looked at.

As I said, our experience in this area is minimal at the moment. We have had four meetings. In fact, there is another meeting of that committee today in Australia. They have already approved six new substances with research we have done and with some information that is coming from industry.

So it's a growing area, but it will require resources. We hope they will be minimal, that we can streamline the processes, but we're learning at the moment.

Mr. Richard Woodfield: I think I can answer this one quite briefly from the U.K.'s point of view. We have made no structural changes in response to this growing trend. I think quite simply if something is regarded as a food, it's dealt with by the food authorities; if it's regarded as a medicine, by the Medicines Control Agency. There is no pre-authorization required for most foods and there are no pre-authorization requirements for unlicensed herbal medicines. Therefore, there is a very limited resource requirement indeed.

Where we are recognizing a need to put in some additional resources is on the difficult question of precisely how you should classify a product. Is it a medicine? Is it a food? Is it a cosmetic? We are putting in some additional resources on that front, but by and large, because of the structure of our arrangements, we are not finding significant resource requirements at the moment.

The Chair: Dr. Keller, would you like to respond?

Dr. Konstantin Keller: I think the situation in Germany is a quite particular one. In Germany we actually have about 1,400 new marketing authorizations for herbal or homeopathic products on the German market, and for herbal products per year we have about 200 applications for new marketing authorizations. These are industrially prepared products that are the type to be put on the market.

I think it's necessary to assess these products to guarantee quality, safety, and efficacy. Because these products are drugs, it's necessary to handle them as very normal drugs.

On the other hand, we think that for very traditional herbal preparations—for example, for traditional herbal tea—it is necessary to have an easy, low-cost system, and in Germany we have introduced so-called standardized marketing authorizations that apply to herbal teas in a very particular way. These standardized marketing authorizations are prepared by our institute and they are published by the Federal Ministry of Health. These packs contain the complete package leaflet and all the information necessary for the product. If a company uses this labelling and these quality requirements for herbal tea, it is not necessary to present any application to the institute.

To give you an impression of how effective this monograph system is, I would tell you that when we started with our Medicines Act in 1978, we had more than 40,000 old herbal teas on the German market. From these 40,000 products, we still have on the market, covered by standardized marketing authorizations, about 20,000 products. These 20,000 products do not take any resources from our institute, with one exception; we have to update the labelling requirements or standardized marketing authorization.

The control of these products on the market...for example, the pharmaceutical inspection is done by the local state health authorities. In Germany we have a federative system, with local states that control GMP and so on. The control here is done by the local state.

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For industrially prepared products—for example, capsules, tablets and so on—I think there should be control, but for classical herbal drugs, such as herbal teas, there should be a monograph system that does not require a stronger agency.

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

Ms. Bennett, do you have questions?

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

I would like to just step back a bit, particularly because of our Australian guest. I have a particular interest in the whole consumer role in setting health policy. I know in Australia you have developed a council or a way in which consumers are more involved in the ongoing development of health policy. Even though it's not particularly the solution to our problem today, it's a prevention aspect, I think, in terms of how we got into this problem here, where government is about to set some regulations that then consumers are very upset about.

In our National Forum on Health there was a commissioned paper on consumer involvement or citizens' reactions. It described the Australia situation, where you have a council of consumer organizations that actually help in the development of health policy. Do you know a little bit about that, or could you just help me with that?

I was hoping to use it as an excuse to come back to Australia and investigate it personally. Maybe I'll do that anyway.

Ms. Laurayne Bowler: You're very welcome to come.

We have a number of consumer associations, but in the health area we have what we call the Consumer Health Forum, which is an umbrella organization supported and encouraged by the federal government to provide specific consumer input to health policy in relation to a whole variety of illness interest groups, from arthritis to diabetes—although there is a separate diabetes association—and so on.

They have input, and on most of the committees we set up, we would invite the Consumer Health Forum to nominate a participant in those committees. We consult them on any of the broad policy issues we are developing. If we're consulting with industry, unless it's very much specifically related to day-to-day management, we would be seeking input.

On the new committee we have established, the Complementary Medicines Evaluation Committee, we do have a consumer representative. There was a consumer representative involved in the establishment and development of the electronic processing facility through which we process these products.

So they've been very involved in the process. We would like to see them be a little bit stronger, in fact.

Ms. Carolyn Bennett: Is one consumer enough on a committee?

Ms. Laurayne Bowler: We try to limit the committees to relatively small committees of broad representation. Usually they're very good, and they make the points. We do, in fact, have two on a couple of committees. The Australian Consumer Association also does provide consumer representatives, but they have a broader focus than just health.

Ms. Carolyn Bennett: Thanks.

I'll wait until the next round.

The Chair: Thank you very much.

I have no more questions from this side.

Mr. Dumas.

[Translation]

Mr. Maurice Dumas (Argenteuil—Papineau, BQ): Thank you, Madam Chair. I will address to our distinguished guests in French.

In some publications here in Canada, and in Quebec in particular, you can see full page ads for natural medicinal products and, in particular, for products against obesity.

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Are these advertisements authorized in your countries? Do you have legislation to control the value of those substances? Can someone be sentenced or can anything be done against a person who has advertised products that have adverse effects? I recall that in Quebec some television personalities were sentenced by the Courts for promoting such products.

[English]

The Chair: Would somebody like to answer that question?

Dr. Woodfield.

Mr. Richard Woodfield: Thank you.

I think the key point to start with is that we make a distinction between a health claim and a medicinal claim. If something is a medicinal claim, then it requires to be demonstrated that it is true and justified.

If it's a health claim, such as “helps to maintain a healthy heart”—that might be a health claim—then that may be more acceptable in a food. However, whatever the claim, if it is erroneous it will be challenged by the relevant authority: in terms of medicines, the Medicines Control Agency; in terms of foods, the trading standards authority.

We have some fairly stringent regulations about the kinds of claims that are allowed in relation to medicines. We have regulations that say you cannot advertise products in relation to bone disease, cardiovascular disease, malignant disease, and so on. In general terms, for medicinal claims, they are only allowed to the public for minor and self-limiting conditions.

I'm not aware of specific prosecutions, but in general, if people are making erroneous claims, they will withdraw them when challenged by the relevant authorities.

The Chair: Thank you.

Dr. Keller, if at any time you want to speak, if you could raise your hand, I can see from here that you would like to speak. Would you like to answer on this?

Dr. Konstantin Keller: It's a little bit difficult for me; I only get about 50% of the questions because the sound is blocked. But I understood that there was a problem with labelling of ingredients and indications and health claims.

The situation in Germany is a little bit different from that in the U.K. Normally, if there is really a health-related claim, it will be a drug.

It's possible, for example, to make a claim that peppermint tea is a refreshing beverage. In this case it will be a food. But if you make a claim that peppermint tea is good for stomach upset, it will be considered a drug.

I think in most cases where you have some health-related claims, and if the presentation of the product is very close to a medicinal product, to a drug, it will probably be classified a drug in Germany, especially if active constituents do not have any function as a food—for example, vitamins or minerals. For those constituents, it will probably be a drug.

For foods and for drugs, we have legislation in Germany preventing misleading or fraudulent information, but this legislation is separate and applies to foods and to drugs as it covers those areas.

For the declaration of ingredients and for the quality control, as I already told you, if such products are drugs, there is a full requirement for declaration of active ingredients, and full labelling requirements as to their use for drugs apply as well to herbal products.

The Chair: Thank you very much.

Ms. Wasylycia-Leis.

Ms. Judy Wasylycia-Leis (Winnipeg North Centre, NDP): Thank you very much, Madam Chair. I'd also like to thank everyone who has come before this committee and for the time you've taken.

• 1025

My first question is to Mr. Keller, and I hope he will be able to get most of this question.

I want to direct my question to Mr. Keller because we've had a lot of witnesses before our committee referring to the German experience, and we've had diametrically opposed views.

We have had some presenters who have held up the German model as something we should emulate. But on the other hand, we have had particularly consumers telling us that the German experience and program would spell the end to access for consumers in this country. They have used examples of prices skyrocketing for basic products like vitamin C. Some have suggested that they have taken vitamins to Germany because it is so expensive there, given your regulatory approach.

I am wonder if you could tell us what the situation is in your country. Have prices of basic vitamins, natural products and herbal supplements gone up in price as a result of your approach, and what has been the reaction of consumer groups and advocates in your country?

Dr. Konstantin Keller: I don't have concrete data on prices, but you have to know, for example, vitamins and minerals can be food supplements if they are within the range of the three times normal daily intake. Such products are available outside pharmacies. They are available in food stores and supermarkets, and they are very cheap. For example, you can have 20 tablets of some multivitamin preparations for less than $ 1 U.S.

On the other hand, if you have very high doses of vitamins, let's say 10 times the average daily intake, these products will be considered to be drugs. In this case there must be a medical claim—for example, prevention of vitamin deficiency in illness—and these products may be sold in special drug shops, even outside pharmacies. These shops are quite cheap and these products are commonly available, so everybody can get these products. They are not pharmacy-only products, because the status or the classification as a medicinal product is not related directly to the outlet. So medicinal products are sold in outside pharmacies as well, even in supermarkets, and they are very cheap.

So I don't see any direct link between the classification of the product as a medicinal product or a food and the product. I know some products that are sold as foods are very high-priced, and some products that are sold as drugs have a very low price, so there is no direct link.

I don't think we have any problem of consumer access to products in Germany if these are old, well-established products. In some cases we have problems if a completely new product is appearing on the market, if it is a new medicinal product, if it has health-related claims even for preventing diseases. In this case it would be classified as a new drug, and for a new drug the requirements are much more intense and demanding than for these well-established products.

In Germany there is a difference. If it's really an old-fashioned, well-established product, it's quite easy to go to the market, to get market access, and these products are quite cheap. But if it is a really new drug, it will be very difficult to go to the market and to have access.

The Vice-Chair (Ms. Elinor Caplan): Thank you very much. The time is just about up. We'll wait for the next round. With the permission of the committee, I was on the list to ask the next question, if I may.

The question I'd like to ask is about the influences of the UN Codex Alimentarius on those substances that are classified as foods, or other World Trade Organization processes, and how they have affected the outcome of natural products. But I'd like a particular discussion around the Codex Alimentarius.

One of the things our committee has heard is that if you leave products as foods, they cannot make health claims. The discussion has been that people need to have information so they can make informed choices about products they're going to use, yet we understand that in the international discussions, particularly around the Codex Alimentarius, that has created some difficulties. I'm wondering what your experience has been and how world organizations have influenced your decision-making.

• 1030

Who would like to begin? Laurayne?

Ms. Laurayne Bowler: In Australia, vitamins and minerals have always been regulated as therapeutic goods even prior to the 1989 Therapeutic Goods Act. So unless they are additives to food, they are regulated as therapeutic goods.

So there would be no difference in the regulation of those, or we don't perceive that there would be as a result of the Codex decision-making process in Australia. There was some anxiety that it was going to change our processes and that they were all going to become by prescription only.

So the community was very upset, but they then realized that in fact these were already regulated as therapeutic goods on a risk-based approach. So high doses of vitamin A, for example, may be prescription-only products, but where products are safe, there's no restriction on the availability of these products either through health food stores or your local supermarket or over the counter in your local pharmacy. So it hasn't affected our regulation at all.

In relation to food, at the moment there is no capacity, except for a couple of very limited claims that could be made for food. But we are looking at developing a food standard that will allow for the making of health claims. That may change the way vitamins are regulated. We don't envisage that at the moment, but until we get the health claims developed, we won't know.

The Vice-Chair (Ms. Elinor Caplan): What is your timing for that?

Ms. Laurayne Bowler: Because of the consultation process that goes on with foods, it could be 18 months or a couple of years yet. It has been mooted for a long time, but there seems to be a lot of work to be done, and it hasn't yet gone out for consultation.

Mr. Richard Woodfield: In the United Kingdom, vitamins and mineral supplements are generally regarded as foods, unless they are of such a particularly strong combination as to present possible risks, in which case they would have to be regarded as medicines. We currently have an ad hoc committee, which I mentioned, that is doing some more work to establish where precisely the level of risk begins.

In principle, I don't think we've had any difficulties in relation to the work of the Codex Alimentarius, because in fact we are quite interested that a number of countries involved there may take a similar approach to that of the United Kingdom in terms of regarding the level of risk, as opposed to the level of need, as the key consideration.

So we're looking for allies in that particular debate. But my understanding is that progress on that front is fairly slow. I think it may be at least another year before the Codex pursues its work on that.

In terms of claims, the key point is the distinction between a medicinal claim—in other words, this is something that has an effect on the physiology—and a health claim. If it's a reasonable health claim, that will be allowed in the United Kingdom.

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

Dr. Konstantin Keller: I already told you that we make a limit with the recommended daily intake, so we have a different approach from that of the U.K. We accept vitamins and minerals up to three times the recommended daily intake for food sold everywhere, but if you have higher doses, we classify such products as drugs.

We have problems with this purely toxicological approach because in this case you will enter an area where the substances will be pharmacologically active. For example, if you have high doses of vitamins you will have pharmacological action, which makes it very close to being a drug. If you leave out the food aspect of these food supplements, I think we will run into problems.

• 1035

This is why we normally do not have such herbal supplements classified as food. I remember one example: evening primrose oil is accepted as a food supplement. We also have fibre supplements accepted as food. But in this cases, these herbal extracts are part of normal nutrition. For example, fibre and gamma linolenic acid are part of normal nutrition and so can be considered foods if there is no therapeutic or prophylactic claim.

But for most other herbal preparations, it's very difficult to find a link to food and to nutrition. For example, we've never accepted preparations such as ginkgo extract as a food. Ginkgo extract, as an example, will always be a drug because it has no food or nutrition to it.

Does this answer your question?

The Vice-Chair (Ms. Elinor Caplan): Yes, thank you very much.

The researchers have suggested that Health Canada might like to make some comment on this, either Mr. Burke or Dr. Cheney.

Dr. Margaret Cheney (Chief, Nutrition Evaluation Division, Food Directorate, Health Protection Branch, Department of Health): Yes, thank you, Madam Chair.

We are active in the committee that is considering the Codex Alimentarius draft guidelines on vitamins and mineral supplements. Canada has taken a similar approach to that of the United Kingdom, in that although we have opposed the development of this particular guideline, if it is developed our position is that the approach should be risk based, to the maximum levels of vitamins and minerals permitted in the products. But at the same time, we must recognize that here in Canada we are currently in the same situation as Australia, in that vitamin and mineral supplements are regulated as drugs in this country.

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

The next person on the questioner's list, Mr. Vellacott, hasn't had a chance.

Mr. Maurice Vellacott (Wanuskewin, Ref.): Thank you, Madam Chair.

I'm not a medical doctor, so this question is particularly for our Australian guest. What do you mean by this “minor self-limiting condition”? And more importantly, I guess, in layman's language, is there general consensus about what minor self-limiting conditions are? I would like a response from Richard and from our guest from Germany as well. Is there universal agreement in terms of what “minor” is? Can you give me a definition first and then tell me if there is agreement across the board on that?

Ms. Laurayne Bowler: That's a general condition or general statement. The way in which advertising and claims are regulated relate to our therapeutic goods advertising code. That code sets out a negative list of indications, disease states that may not be referred to by sponsors, like heart disease, diabetes and cancer. There's actually quite a long list of diseases that may not be referred to in advertisements.

The list is developed by the Therapeutic Goods Advertising Code Council, which is a body set up originally under the Broadcasting Act and our trade practices. Recently they decided that they didn't want to auspice this body any more, so it is now set up under the Therapeutic Goods Act. It consists of a committee that is representative of industry, consumers, health professionals and advertisers, and there is one representative from the therapeutic goods administration. They are responsible for maintaining the code and for updating it.

I mentioned the 1996 review. The nutritional industry in Australia was concerned that the code was very restrictive. At the moment, we're in the process of reviewing the code through that code council.

The application of some of this is a little bit difficult, and industry is very creative when it comes to actually developing claims, which is fair enough. It's a marketing tool for them and that's fine. It's sometimes a matter of interpretation as to whether something is for the temporary relief of pain or whether it's actually saying that it's going to cure the pain.

• 1040

So we do have a lot of interpretation. This is usually looked at. Once we've done that as an administrative function—because that's the only practical way to do it—these are actually published as guidelines and there is an opportunity for the sponsor to appeal it. There is also an opportunity for consumers to complain if necessary, if they feel that is a problem, and there is a complaint mechanism that is set up, again, as a co-regulatory approach through the industry associations and also through the Therapeutic Goods Advertising Code Council, where complaints can be heard as to whether sponsors have exceeded those claims.

Mr. Maurice Vellacott: If I could just interject, Laurayne, you're saying that those things not on that list are, in effect, all those regarded as minor self-limiting conditions. If I saw your list of those that are not on the minor self-limiting list, would it be the same as the lists in the U.K. or Germany? Do you have any cross-references?

Ms. Laurayne Bowler: We don't.

Mr. Maurice Vellacott: You do your own internally and without regard, necessarily, to what's done elsewhere.

Ms. Laurayne Bowler: Those who are on the committee and are looking at that will usually bring to us what is happening in other countries. That is certainly part of this major review that is happening at the moment, in that we are being presented with the sorts of claims that are allowed in other countries, and the TGACC is actually considering whether we believe there is a public health and safety issue in allowing those claims to be made to the public.

Mr. Maurice Vellacott: So there may not be unanimity in terms of what a minor self-limiting condition is, though.

Richard.

Mr. Richard Woodfield: I think perhaps the key point is that in the United Kingdom we have the three categories of drugs: drugs that are prescription only; drugs that can also be available from a pharmacy; and a third category, the general sales list, drugs that can be generally available, not necessarily from a pharmacy, drugs that you can get from a supermarket, let's say. When a drug is on the general sales list, in effect it is likely to mean that it is for a relatively minor and/or self-limiting condition.

Mr. Maurice Vellacott: The list is: strictly prescription; non-prescription; and last, the general sales list. Is that correct?

Mr. Richard Woodfield: There are three categories. The first one is prescription only, available from a doctor. The second one means that it is available not necessarily on a prescription but only from a pharmacy. The third category means that it is widely available and in particular is for minor, self-limiting conditions, and reasonable advertising is allowed of those products.

Mr. Maurice Vellacott: So have you done cross-referencing with other countries or have you worked this out on your own in terms of what is or what isn't on these lists?

Mr. Richard Woodfield: Essentially, I think, we have done it ourselves, but I think we would find a fair degree of commonality with other countries in Europe, though they don't necessarily have a specific category of “general sales list” in the sense that we do. I think our regime is more liberal in that sense. But I don't think we have precisely established whether every country has exactly the same products.

Mr. Maurice Vellacott: I'd like a quick response from our guest from Germany.

Dr. Konstantin Keller: Yes. We have legislation that is quite similar to that of the U.K. and Australia. We have legislation on advertising and on those products that can be sold outside pharmacies. And then there is legislation for the catalogue of diseases for which products are not allowed to be advertised about for purchase by the general public. So I have all these indications given by my colleague from Australia, as well as the general list. And I have one other example from the general list that cannot be advertised—sexually transmitted diseases. They are not allowed to advertise something as a cure.

• 1045

I didn't compare the diseases on the different lists—for example, the general sales list in the U.K. and the Australian list—but I think that to a large degree they will be comparable in the three countries.

But I think this system is quite similar to that of Australia and the U.K. You have the legislation and you have a catalogue of diseases that is continually being updated by an expert committees and published by the minister as an addendum to the legislation.

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

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

I wanted to begin by thanking each of the three presenters. I think what you've said this morning is most interesting, informative and enlightening, and I appreciate it.

First I want to ask Ms. Bowler two questions, and then I have two general questions for each of the three presenters.

Ms. Bowler, in your earlier comments you said that in fact there is full disclosure of adverse reactions in terms of claims that practitioners have to make. I wonder if you could elaborate a little bit in terms of the mechanism you have for that disclosure, how that report flows and where it goes and what is then done with that information.

Ms. Laurayne Bowler: If I said “full disclosure”, I might have been a little misleading.

What we do have is an obligation on sponsors. When they put their product on the register, they are obliged to report any adverse reactions occurring during the marketing of the product that they become aware of.

Also, we encourage health practitioners to submit reports of any adverse reactions they see in the patients they're treating. We have a special committee, the Adverse Drug Reactions Advisory Committee, which actually looks at those reports when they come in and ranks them as probable, possible, or not necessarily related to that particular substance. We produce a report of all of them and that's all published in a generic sense. There are no identifiers of the individual patients or the individual doctors, but we do keep a monitoring record. That helps us in assessing the sorts of controls, whether there are any additional controls or warning labels needed or what action needs to be taken in relation to products.

To date, this has largely focused on the orthodox pharmaceutical drugs. Mostly, medical practitioners, pharmacists and hospital emergency units submit these reports. We have had some reports of adverse reactions to complementary medicines. What we are looking at and what was recommended in the review we had done recently was that we should look at mechanisms that would encourage practitioners of natural and traditional therapies to start reporting these reactions.

There are also some initiatives being taken by our consumers to get consumers to report. The problem with consumers' reporting is that you don't know enough scientific information to know just how useful that report is, although it's an untapped source. The consumer organizations are doing some work on how best to tap into that source of adverse reports, and we hope we'll have a mechanism to encourage those other practitioners to report to us very shortly.

Mr. Lynn Myers: Thank you very much. Like Canada, you have an aboriginal community, and I wonder how widespread aboriginal medicine is and how you treat those kinds of medicines or products.

Ms. Laurayne Bowler: We actually do have an aboriginal pharmacopoeia that was produced, but there is very little use, in a wide sense, of aboriginal traditional medicines. Personally I think that's a shame, but there is nothing to actually stop somebody putting that onto the register.

Perhaps I should just clarify something. In relation to herbal, traditional and natural medicines, practitioners who are dispensing for individual patients are exempt from the need to put their products on the register; pharmacists don't need to and natural practitioners don't need to, provided it is for that individual patient. What we are talking about with the register is largely commercially produced products. It seems at this stage that nobody has taken up the challenge to produce aboriginal traditional medicines in a commercial sense. Probably the only one we have any sort of commercial market for is Ti tree oil, which sells quite well.

• 1050

Mr. Lynn Myers: Thank you very much.

The Vice-Chair (Ms. Elinor Caplan): Okay. Mr. Elley, then Ms. Carroll, then Ms. Wasylycia-Leis.

Mr. Reed Elley: I believe it should be Judy.

The Vice-Chair (Ms. Elinor Caplan): No, actually it's supposed to be the Bloc, then the Liberals. I have a list; you're on before, if you....

Mr. Reed Elley: I would defer to Judy; I think it's her turn.

The Vice-Chair (Ms. Elinor Caplan): Okay, Ms. Wasylycia-Leis.

Ms. Judy Wasylycia-Leis: Thank you very much.

I'd just like to follow up on Mr. Myers' questions on the broad topic of risk. We've heard a lot of presentations before our committee about risk—not so much in terms of problems associated with high dosages or dosages that produce therapeutic results, but more in terms of risk that comes when there might have been product substitution, there might have been additives, there might have been treatment of products before they were harvested that might be harmful, problems of reactions between that particular herbal product and another drug or a food.

One of the issues we have to deal with as a committee is what kind of capacity we have within the public sector, within government, in terms of scientific surveillance, assuring botanical authenticity, being able to research when an adverse reaction is reported. In each of your countries, what arrangement do you have, either within government, within the public sector, or that is government sponsored to provide independent research and scientific surveillance?

Mr. Richard Woodfield: Right. We are equally worried about the problem of contamination and substitution, which we have discovered in some cases with traditional Chinese medicines and also ayurvedic medicines in one or two cases. Some very strange and dangerous substances have got included in some of these products.

I think it's fair to say that we definitely haven't solved that problem as such. We will be looking at it further. But one area where we have taken some steps is when a particular issue came up—and I think Australia had the same problem as well—in terms of confusions between two substances, stephania and aristolochia. Stephania is relatively harmless, but aristolochia is relatively dangerous. We encountered a number of instances of contamination.

What happened was that we have access to some testing facilities and developed appropriate tests that would enable one to tell at a very fine level whether there in fact had been substitution. I believe that test—although I'm not a scientist—is fairly time-consuming, but we're now in the position to deal with that particular problem. That was a rather ad hoc response. We now need to look at a more general approach to dealing with the question of contamination and substitution.

Ms. Laurayne Bowler: As we've mentioned, we do have a system for checking when we become aware of a problem. The other check that we have is that all sponsors are expected to comply with the code of good manufacturing practice, which means that they must in fact have in place procedures to check the identity of the products and the raw materials they're using. With herbal materials this is not always that easy and that simple. We do have examples. Recently we had one with.... I can't remember it; I'll come back to it. We had one where the wrong variety was in fact being used.

What we are doing is working with our industry when we discover these to actually identify the testing methodology and make that available to them to improve their quality control within the industry. As with the U.K., we have had instances of spiking of various medicines. Our laboratories do a targeted testing program. When something alerts us that there may be a problem, they will test those products by calling in samples from sponsors of those particular products.

• 1055

In other areas, such as contamination with pesticides, heavy metals, and so on, we are currently looking at developing a general standard. We're in fact waiting on the development of what happens in Europe before we make a final decision about that, so we can harmonize with the rest of the world if that's at all possible.

The other area where we are also doing some more work at the moment is in the highly concentrated extracts. What we are finding with a lot of the herbal products is that many of these are in concentrations that were not in traditional medicines. The definition that we currently have in our regulations allows these concentrated regulations to get in under the herbal substance definition. While most of them are probably not a safety concern, we just need to be assured that there is no safety issue. So we're looking at a way in which we can do that without imposing an unnecessary burden.

The review that we had suggested, that we should have a tenfold inspection ratio, was rejected as being too restrictive. We have recently put out a discussion paper to industry, which looked at simplified extracts and more complex extracts. The industry, I might say, do not believe that's the way to go, and they have volunteered to come back with something, probably related more to dosage.

It's a complex area, and we're still exploring it.

The Vice-Chair (Ms. Elinor Caplan): Doctor Keller.

Dr. Konstantin Keller: Yes, I would like to comment on this.

In Germany we have the situation that with our new Medicines Act from 1978, all these products are classified to be drugs. So all these herbal products are classified as drugs, and the good manufacturing practices have applied to these products since 1978. So if you follow GMP, I think the risk of fraudulent products or adulteration is reduced by a lot. If you apply some adjudical standards on the question, you will substantially reduce the risk of adulteration and such things.

On the other hand, we made a review of the literature on all these products that are notified to our institute, and we found out many products that present risk. One good example would be aristolochia. We identified the risk of all aristolochia-containing products in 1980, and we had to take from the market in 1981 all products on the German market that contained aristolochic acid. So for Germany aristolochic acid was not a problem, because these products were already eliminated in 1980 and we have good control of producing this product.

We have the experience that if you really have an idea of the national market, if all the products are notified, if you go through the literature you can do a lot for improving the safety of these products if you have them controlled as drugs, which implies good manufacturing practices as well. I think this gives good safety of the products on the German market.

The Vice-Chair (Ms. Elinor Caplan): Yes, but the question was to clarify what testing you do yourselves. Or do you rely on good manufacturing practices?

Mr. Konstantin Keller: Our institute has only very limited possibilities for doing testing ourselves. We've made literature research. If we identify a problem, we take action and ask the pharmaceutical companies to perform studies to clarify the question.

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

I would like to inform the committee that I've had a request that we take a break. However, since we started late, the committee may want to just continue and those who need to take a break will do so. I also want to inform the committee that at eleven o'clock I'm due at another committee, so Mr. Elley will be taking the chair at that time.

• 1100

Is there a consensus that we continue?

Some hon. members: Agreed.

The Chair: We'll continue.

The next questioner is Ms. Carroll.

Ms. Aileen Carroll (Barrie—Simcoe—Bradford, Lib.): Thank you, Madam Chair.

Ms. Bowler, at the outset I was a little disappointed at your response to my colleague's question about the aboriginal resources in that regard. I was disappointed, not critical.

I had occasion a number of years ago to spend some time in Armadale, at the home of a colleague who was working very closely with the aboriginal community. I guess I thought the situation was otherwise, and like you, I feel it's a shame it's not.

We've had some testimony from manufacturers who have come before our committee. The stories they tell are that they find relating to government in the area of herbal remedies is expensive, and by the time they have gone through the process there is an incurred cost to them in bringing a product to market.

I listened closely to your insights this morning. You mention in Australia pre-market assessment, which is divided into two categories of “registered” and “listed”. You mentioned then—and I'm just checking in with you here—that under the listed category, most but not all of the herbal homeopathic vitamins and so on are listed.

I understand then that there exists a co-regulatory approach, and you have there industry, consumers and regulatory agencies who oversee or deal with the products that must come through this agency before they go to market.

Is this not creating a considerable level of bureaucracy that then creates for manufacturers in Australia similar costs, or would you say no?

Ms. Laurayne Bowler: I would say no. When I'm talking about a co-regulatory approach, particularly for the listed products, the industry itself makes a declaration in relation to its product. The regulatory agencies make a limited amount of checking of the data supplied by the company itself.

The cost for it to do that at the moment is $ 220. When we go to full cost recovery, as of July 1, we're still negotiating the fee, but it may go up to $ 350, or something around that, to put in an application. There is then an annual fee they need to pay to keep the product on the register, but again, that is about $ 200 or $ 300 per product.

Ms. Aileen Carroll: So if you're allowing industry to be declaratory, as you're saying, the onus there is to self-regulate it, in a way.

Ms. Laurayne Bowler: Yes, that's right. So they make a declaration that they have complied with all the necessary requirements. They tell us what's in the product. They give us a list of all the ingredients.

They say it's fairly onerous putting that information together. It takes them a couple of hours to actually fill in the electronic database to put that application to us. A lot of them actually use consultants.

We are working on improving that database to make it more user friendly and easier. Part of the delay in putting the information in is largely the number of ingredients that are in a lot of the products. So it's fairly slow going to include those.

The costs to industry in some respects come more from putting in new products. This is where they have had probably a legitimate complaint—that it has been very difficult to get any new substances since the act actually came into operation. We are now putting in place mechanisms to simplify and streamline that process.

As I mentioned, we are still in a state of development as to how we might do this. We recognize that these products are largely not patentable, so one sponsor is not willing to submit all the data, have it declared to be listable, and have everybody else piggyback on the whole exercise. That is why we're looking at whether or not the research, which will largely be literature-based research, will be done by the TGA with any submissions that industry or consumers wish to make.

• 1105

Ms. Aileen Carroll: Thank you. That's most helpful—and somewhat relevant, it seems to us.

Ms. Laurayne Bowler: Thank you. That's excellent.

The Vice-Chair (Mr. Reed Elley): Did you want anyone else to answer that question or was it just directed to Ms. Bowler?

Ms. Aileen Carroll: Well, I guess I was writing madly when Ms. Bowler was speaking. But, Mr. Chair—

The Vice-Chair (Mr. Reed Elley): You have about a minute and a half left.

Ms. Aileen Carroll: But I have another question for Dr. Woodfield, and I'm afraid I'll get cut off my time.

The Vice-Chair (Mr. Reed Elley): You have a minute and a half.

Ms. Aileen Carroll: All right. Thank you.

So I will ask you, Dr. Woodfield, and then if by any good luck there's some time left and the others have the opportunity to respond, yourself included....

The question I had for you, Doctor, was this. You indicated during your testimony this morning that there is a joint health claims initiative under way in the U.K. involving government and consumer groups and industry, of course, as well. I wondered what the goal of this initiative is. And second, if I can fit this in as well, are there any intentions to develop standards of health claims in the U.K.?

Thank you.

Mr. Richard Woodfield: Yes, I think the intention of this initiative is to reduce the confusion, really. We've had a lot of ongoing discussion and disagreement on individual cases, a lot of what you might call shadow-boxing at the margins as to whether something is or isn't permissible. As well as the regulatory authorities, the trade associations are, I guess, anxious about the amount of time and effort that goes rather fruitlessly into such discussions. They're also anxious about the activities of those organizations outside the trade associations that are perhaps taking advantage of a rather difficult situation.

So the aim is to bring some greater clarity and to make it much easier to determine whether a claim is legitimate, to actually have maybe some agreement on what specific claims are allowable in relation to specific issues. Now, that initiative has some way to go yet, but in principle I think it's a very helpful development.

The Vice-Chair (Mr. Reed Elley): Thank you very much. Your time is up.

Mr. Myers.

Mr. Lynn Myers: Thank you, Mr. Chairman. I wanted to ask each of the three presenters the following two questions. First, do you ban products, and if so, do you have a list of those banned products? Second, do you have an appeal process in place where people who disagree with the regulatory agencies have an avenue of appeal?

I'd ask each of the three if they would answer that. Thank you.

The Vice-Chair (Mr. Reed Elley): Who would like to go first? Perhaps we could hear from Dr. Keller.

Dr. Konstantin Keller: In Germany we have a pharmacovigilance system for all medicinal products and we have banned herbal and even homeopathic products from the market, as we have done with all the different other medicinal products as well. We have a very complicated administrative law, and the companies have the right to make an appeal.

The first step of the appeal against any ban from our institute is internal appeal at our institute. So there will be re-check of the dossier by our lawyer, and if the ban still stands, the company has the right to make appeals to the administrative court. They have three levels of administrative court, and this opportunity is used by many companies if they do not agree with our decision.

So there is a possibility to make appeals, and the companies even have the right to give out new data during the court appeal. So it's quite often the case that we have had to ban a product because we have found risk aspects that could not be clarified, and during court appeals the company presented new studies and we agreed at court.

Does this answer your question?

Mr. Lynn Myers: Thank you very much, yes.

Mr. Woodfield.

Mr. Richard Woodfield: There isn't a list of banned natural health products as such in the United Kingdom, and in fact we tend not to go in for banning individual products. What we tend to do is upgrade the actual controls over them. For example, if a drug is found to have more of a risk than was first thought, it may well be upgraded to make it a prescription-only medicine.

• 1110

In relation to unlicensed herbal remedies, as I mentioned in my opening remarks, there are very few controls over them. What we do have, however, is a list of herbal substances that was set out in the 1977 regulations. They don't ban them, but what they do is give certain controls over sale and supply. There's a list of two or three pages of such herbal substances, and we are currently thinking about whether we need to update that list because obviously it's about 20 years old now.

The Vice-Chair (Mr. Reed Elley): Ms. Bowler.

Ms. Laurayne Bowler: Like the U.K., we have a list of restricted herbs that may not be included in listed products. These would have to go through the registration process.

There are very few herbs that are banned. Aristolochia would be one. There are a couple of others that are actually banned by domestic policy, which is run by our states, in fact. Then there are other herbs that would be banned under international treaties, such as papaver somniferum, which is your opium poppy, and so on. Those are the bans, but largely their restrictions are on the basis of level of risk and whether or not they need to be listed or whether they have to be registered products.

Do you have a question?

Mr. Lynn Myers: The appeals process.

Ms. Laurayne Bowler: We have a couple of systems of appeal. Generally in relation to specific products the sponsor may first appeal to the minister. If that appeal is unsuccessful, they can appeal to our administrative appeals tribunal, which will review the product, and then through to the federal court if that's the way they wish to go.

The other way, if they believe the process was flawed, is that they can go through the administrative decisions review tribunal route, which is again a federal court mechanism that they can appeal on.

Mr. Lynn Myers: Thank you very much.

The Vice-Chair (Mr. Reed Elley): Thank you.

I'm on the list next here for a question. Then, Mr. Volpe, do you have one you'd like to ask after that?

I'm very interested in the whole question of health claims. I think we all are. It's something that has occupied a fair amount of our time as witnesses have appeared before us.

I'm very intrigued by what I think I hear from both Australia and the U.K. about the fair degree of cooperation you have amongst industry and consumer groups in terms of health claims. I think, Mr. Woodfield, you mentioned a joint health claims committee that had these people on them. Can you elaborate a little bit further on that?

Then I want to ask Mr. Michols a question as to whether or not we have this in our system, and if not, is there the capacity for it?

Mr. Woodfield.

Mr. Richard Woodfield: We do have strong links with the trade associations. I think one of the reasons for that is simply the very difficult question of trying to establish whether something is a food or a medicine. I think it's clear from what I said earlier that there is quite a lot of room for discussion, and so it's been mutually recognized, to the advantage of both the regulators and the trade associations, that we need to reach a clear understanding as to what is permissible and what isn't. So in a sense, I think we're drawn together by mutual self-interest in terms of achieving greater clarity.

That is also the thinking behind the joint health claims initiative. There had been so much confusion on this subject that it just seemed eminently sensible to try to get a clearer agreement on that. So that work is going ahead.

The Vice-Chair (Mr. Reed Elley): Mr. Michols, would you like to tell us what's happening to Canada in terms of this kind of cooperation? Does it exist?

Mr. Dann Michols (Director General, Therapeutic Products Programme, Health Protection Branch, Department of Health): I believe it does. In Canada, as with the other jurisdictions, the first obligation is for the sponsor who wishes to receive a marketing authorization to present the data upon which it wants to make a particular claim. There are a number of policies in place that indicate how much data is required and what type of data is required. It's whether it's a traditional medicine claim or a new chemical entity claim, as has been explained.

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We, as the regulators, then review the sponsor submission and determine whether or not we think there is sufficient justification for the claim. Again, this is against those same policies that we have predicted.

We have recently put into place an expert advisory committee on complementary medicines. This is made up of representatives of the various scientific disciplines and also various practitioner disciplines. It's not only, as Laurayne has said, the orthodox side, but also the complementary side.

It's our specific mandate to this group to help us work through much of these claims and help us set particular standards or monographs, as has been mentioned, against which the sponsors could say that they do attest to this particular monograph. It would then be approved.

This process of working through what these health claims might be, and the data that would exist to justify them, is a proposition. We don't have industry representation on that expert advisory committee per se. It's made up of representatives who are practitioners and scientists, but the initial documentation comes from industry, so it has an input in that regard.

The Vice-Chair (Mr. Reed Elley): I'd like to ask you this: do you think there would be then a place for industry representation on our committee here in Canada?

Mr. Dann Michols: There's definitely a place for industry participation. It gets problematic if they are sitting on the actual committee. This is within industry as well. One company is not particularly interested in having the representative from another company sitting there reviewing its case and so on.

We've tried to separate the data coming in from the deliberation to ensure that there is no conflict of interest on the actual advisory committee in this regard.

That said, we have offered to all of the industry associations that we deal with right across the board—that's 13 or 14, and also the natural health products area—for them to develop the first draft of the monograph. We've said we're prepared to review it. They've got the resources more than we have, so they should develop that first draft of the monograph. Tell us about compositions, claims, etc., and then we will have that body review it. That would be an opportunity for industry to have a major input as well.

The Vice-Chair (Mr. Reed Elley): Thank you very much.

Mr. Volpe.

Mr. Joseph Volpe (Eglinton—Lawrence, Lib.): Welcome again to Ottawa, all three of you.

I wanted to touch on a question. I hope you didn't elaborate on this when I was absent from the room.

We've had some interventions before our committee that have suggested that much of the process in validating the natural herbal products has an implication on the practitioners. In Canada, the practitioners are certified and licensed by the provinces. It's a much more complex situation for us. Do you have that consideration as well in your jurisdictions?

Since I've made myself clear, I'll confuse it a little bit more by asking whether in fact many of the issues and much of the study with respect to natural and herbal products is associated with competing practitioners and groups who are attempting to ensure that medical services or practices are maintained to a particular standard that may be exclusionary.

Mr. Richard Woodfield: The U.K. may be slightly unusual in that literally anyone can practise as a herbal practitioner. The herbal practitioner is not defined in law, so anyone can practise in that way, which is something that sometimes causes surprise. There has been a very strong emphasis on the freedom to practise.

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As a consequence of that, the responsible herbalists clearly recognize that if they are to maintain this privilege, they need to have a very strong self-regulatory approach with good codes of practice and ethics and so on. So there have been a number of promising developments on that front with a number of different herbalist groups.

We find that what you do sometimes get is competition between different groups of herbalists who maybe take a slightly different view of, for example, how much education or training is required to be a competent professional. So I think there will be a tendency toward competing groups with different views. That's the U.K. position.

Does that answer the question?

Mr. Joseph Volpe: Yes.

Ms. Laurayne Bowler: In Australia, as with the U.K., there is no regulation of herbal, natural practitioners as such at the moment. There has been a lot of push for that, but because of the diverse groups and because they can't get their act together, they haven't actually come up with any system as yet.

The regulation of practitioners is for our states and not at our commonwealth level. Recently the states have decided that they would like to look at traditional Chinese practitioners to try to get some form of accreditation for those practitioners. We only, I think, have to deal with 28 associations as far as they're concerned, so that is a much smaller group than the rest of the practitioners. We're hoping that this might provide a model in fact for the other natural practitioners to follow in some form of regulation accreditation.

The driving factor for most of the practitioners here is that under our drugs and poisons legislation, they cannot have access to anything that is a controlled substance. So they can only access those herbs that don't come within the poison scheduling. So things such as ephedra, to which the Chinese herbal practitioners would dearly love to have access, is controlled in Australia. They they cannot prescribe that for their patients.

So this would provide them with access to a wider range of herbs to use, but we need to be satisfied that they have the qualifications to deal with that. But without some form of accreditation, it's very difficult to know whether all those practitioners meet that level.

Dr. Konstantin Keller: We have non-medical practitioners in Germany as well. We have several thousands of non-medical practitioners in Germany. They need to have a state licence and they have to pass an examination to get this licence, but the examinations mostly focus on the protection of public health. So they are asked if they know the legislation and if they can recognize dangerous diseases.

If they have their licence, they're allowed to practise, but they're not allowed to prescribe prescription-only products, so they do not have the same rights as do medical doctors. These non-medical practitioners are very active in Germany. In Germany, we have three committees in our institute for alternative theories, and non-medical practitioners are represented in our committees as they play a very active part in these committees.

I didn't understand your question very well about competition between different practitioners, but my impression is that there's much more competition between, for example, regular homeopathic medical doctors and conventional medical doctors than there is between non-medical practitioners and medical doctors. So the difference in some areas was much bigger than the difference between non-medical practitioners and medical doctors in the area of herbal and homeopathic drugs.

So I don't know exactly what your question was about competition between different groups. Does it answer your question?

Mr. Joseph Volpe: Yes, very well.

The Vice-Chair (Reed Elley): Thank you very much, Dr. Keller.

Ms. Carroll.

Ms. Aileen Carroll: I wondered if all three of you would care to comment on one issue that's come before us, and that is whether you see the need for perhaps another category for those items. Has this come forward to you? You deal with drugs on one hand, and registered and other names are used by our guests, and food on the other. Have you looked at the possibilities of extending those two or looking at a third?

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Ms. Laurayne Bowler: As part of the review we did in 1996-97, this was one issue that was suggested. The difficulty we had was in defining a lot of these products at the food/drug interface. We felt if we actually created another category, we would end up with two grey areas instead of one, and we preferred to focus our attention on the risk factors and getting that right, the level of regulation within the regulatory framework that we already had, and working with the food standards people to perhaps develop more health claims that could be used on foods so that some products might in fact move out of the therapeutics area and into the food area. Recently, for example, the food standards in Australia have developed a sports food standard, and that has taken some products that would previously have been therapeutics into the food area, although they cannot make claims.

So it is an area that's being thought about, but, as I say, we would prefer to focus on that one grey area and on level of risk.

Mr. Richard Woodfield: Yes, the U.K. would take an almost identical approach. If we were to have a new category that would create new borderline issues, we take the view that it would be better to concentrate on clarifying and improving the existing boundaries.

Also, in terms of looking at the future, given that any significant changes would have to involve the European Union, it would be very complicated and very time-consuming to in effect try to construct a new regime covering the whole area. I doubt whether that's likely to be realistic.

The Vice-Chair (Mr. Reed Elley): Doctor Keller, would you like to respond to that?

Dr. Konstantin Keller: It's very difficult, again, to answer this question, but the main question is what would be the criteria for this new category? Which criteria should apply to this new category of food?

We had one good example to show the problems. We had one product that was presented as a drug and that contained fibre, and the claim was reduction of serum cholesterol. This product was marketed as a food in other countries, with the claim that the product contained fibre and the fibre could reduce serum cholesterol. When we checked this product, we found out that the dosage in the product was much too low to give any effect and that the stability and the pharmaceutical quality of the product were not guaranteed.

So what we are doing, in testing drugs and giving marking authorization to drugs in this field of herbal drugs, is we are testing if the information given by the company is right. If it's right, it could be accepted as a drug as well. And if we find out that, for example, as in this case, the pharmaceutical quality is bad or the posology, the dosage, is too low to give any effect, we do not think such a product would be an acceptable product to be sold as food. It's just a substandard product.

We've found it very difficult to establish criteria for this new category of foods. We think it would be much better to have adequate criteria for herbal products in the drug legislation, not to create a new category of foods.

Thank you.

The Vice-Chair (Mr. Reed Elley): Thank you very much.

Mr. Vellacott.

Mr. Maurice Vellacott: I have two questions. I think they can be for the most part answered with a yes or a no from each of our guests today.

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The first one is, do you allow for warnings to be printed on labels? Is that a possibility? Then the other question would be, do you have policy or legislation that allows for the importation of product for personal use—something that would not be allowed for sale in your own country, but people are allowed to bring it in from another country, some substance like that? Yes or no?

Ms. Laurayne Bowler: Yes.

Mr. Maurice Vellacott: Okay.

Mr. Richard Woodfield: Yes, we allow importation in that way.

On the question of warning labels, for licensed products, the specific warnings have to be agreed. For unlicensed herbal remedies, they are not actually required; it's optional.

Mr. Maurice Vellacott: But they're allowed.

Mr. Richard Woodfield: They are allowed, yes.

Mr. Maurice Vellacott: Okay.

And our guest from Germany?

Dr. Konstantin Keller: In Germany, if these are drugs, warnings and full labelling are required. If they are foods, warnings are allowed.

Importation for personal use is allowed, and even importation by prescription of a medical doctor is allowed, if the product has a licence in a different country. For example, in Germany, if a medical doctor prescribes a herbal drug that has a licence in India, it can be imported for his patient by a pharmacy.

Mr. Maurice Vellacott: Okay.

For all three specialists today, are you frequently running into particular problems with the personal importation—problems that may not be much different from what we face in Canada? What would you be facing on personal importation of products that are not allowed for sale in your own country?

Ms. Laurayne Bowler: Our personal import scheme does create some problems, because it tends to be abused a lot. Sponsors try to sell things through the Internet and others use it as a back-door way of actually bringing things in and then supplying them in Australia. So it does have its problems, but we don't want to restrict people from access to medication or products they wish to purchase, provided they actually understand what the risks are.

There are some prohibitions on imports. If it contains a narcotic or a psychotropic, those are prohibited unless they get specific permission to bring them in, which probably requires a doctor's prescription. So it's not totally banned, but it would be restricted.

Otherwise, if there's no prohibition on it, they can bring those products in for their own personal use, up to three months' supply at any one time and up to five shipments a year.

Mr. Maurice Vellacott: Thank you, Laurayne.

Richard.

Mr. Richard Woodfield: I do not think we have substantial problems in import for personal use. Where we have a bit of an issue is in relation to, say, some of the traditional Chinese and ayurvedic products, which come in via the suitcase trade, for personal use. Some of the people have rather large suitcases, and we get quite a lot of that. Some of those products may not be of very high quality. They're the ones that may well sometimes have contamination and substitution. That is a bit of an issue for us.

Mr. Maurice Vellacott: Dr. Keller, could you respond to that as well?

Dr. Konstantin Keller: This is a question of misuse of regulation. If it's really for personal use, there's no problem. If this is not, for example, a classified product, it's very clear. If the product is a prescription-only product or a narcotic, your personal import is not allowed. But if it's, let's say, a herbal product that's not classified, it could be bought outside Germany and imported to Germany. It is possible to do so.

What my colleague from the U.K. talked about is a concern in all countries, that this regulation might be misused, and in that case it will be a problem. In principle it's a problem of distribution of unlicensed drugs; it's not so much a problem of import of drugs. It's not so much related to the aspect of importation but to the distribution.

The Vice-Chair (Mr. Reed Elley): Thank you very much.

Ms. Wasylycia-Leis.

Ms. Judy Wasylycia-Leis: Thank you very much, Mr. Chair. I have three questions. I'll ask them all at once and see whoever wants to answer which one.

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The first question goes back to harmonization. To what extent is harmonization, with respect to natural health products, happening globally? Does it have any bearing on the work we're doing? Should we in fact be putting our work into the context of those harmonization plans in order not to have to reinvent the wheel later on down the road?

The second question is rather open-ended and hypothetical. If you had the opportunity to start again and redo your whole system in each of your countries, what changes would you make?

Lastly, since we're starting from scratch, what would be the best advice you could offer us, as a committee, as we work to prepare our report in this area?

Mr. Richard Woodfield: Perhaps I can answer the easiest part and leave the difficult ones for the others.

On the question of harmonization, frankly, if you were to wait for the European Union to have genuine harmonization, your committee could be sitting for quite a long time. Undoubtedly, work will continue, but as we've seen, for example on the question of levels of vitamins and mineral supplements, there are differences of approach in terms of whether it's based on safety or need for the product. These may be resolved over time, but it's not something that's going to happen very quickly.

Likewise on the herbal front, the European Commission has a study at the moment that is collecting information about the various regimes and will go on to look at the possibilities for change. But I can foresee that it could be maybe four, five or six years, or indeed very much longer before we have any degree of consensus and harmonization on that front. Even when we do have such harmonization, I think there will still be plenty of scope to allow for individual countries' individual traditions, whether it be ayurvedic, aboriginal or whatever.

If we were to start again and do something completely different, I think that's a rather difficult question, really. I would perhaps allude to one of the points I made at the outset, in terms of how we handle herbal remedies. At the moment, if it's a licensed product, it is subject to stringent regulation, markets' authorization procedures. If it's an unlicensed product, it is subject to very little regulation at all, and that is a rather stark distinction. If we were starting again, maybe we wouldn't have such a stark distinction, because I know other countries have various sorts of midway positions.

That's perhaps the most obvious change one might consider, but it's very difficult to rewrite history.

Ms. Laurayne Bowler: I think it is very difficult to get a lot of harmonization because we are so disparate. But it is a global market and we need to be aware of what is going on in other countries and share, as we're doing today, our experiences to try to minimize impact on industry, to ensure consumers have as wide a choice as possible. But ultimately it comes down to what is appropriate for public health and safety in the individual countries, and that depends on a number of cultural and regional factors that we need to take into account.

On harmonization in relation to things like standards, I think it's important that where the product is coming from one country to another, there is a capacity to have some sort of harmonization on the level of standards. We're certainly very conscientious of that, and looking toward what is happening in Europe and in other countries, including the United States and Canada, to see what standards are being used in those countries and to see whether or not we can actually adopt those standards within Australia.

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What would we redo, and what advice would we offer? That's a very big question.

There are a couple of things that from the Australian perspective, looking at the problems we have, I wish we could resolve. One is the food/drug interface and getting an appropriate level of regulation between the two to protect public health and safety without going overboard. If there was some way in which we could actually find a simplified way of doing that, I think that would be wonderful.

I think we are currently trying to review the definition of “food” that currently is in our Therapeutic Goods Act. I think the only way we can possibly do it in a way that's going to be useful and provide transparency for industry is to come up with some type of pragmatic approach to clearing things to be a therapeutic good, or not to be a therapeutic good, after consultation with industry. I hope we can work toward something along those lines, but it is a very difficult area.

I really don't know what advice to offer you except that we believe a risk-based approach is probably the simplest way of going in the protection of public health and safety. With adequate warnings and information, it enables consumers to make an informed choice that will not compromise their health and safety.

I don't necessarily believe we've achieved that in Australia, but that's what we're working toward.

The Vice-Chair (Mr. Reed Elley): Dr. Keller.

Dr. Konstantin Keller: On the question of harmonization, I'm quite optimistic. For vitamins and minerals, I think the European Union has done it a good way. We have a draft directive on food supplements. I think on the part of vitamins and minerals, there could be agreement.

For example, for herbal medicine problems, we have good initiatives from the WHO. We have very good criteria for quality testing from WHO. We have model monographs on active herbal ingredients from WHO. Within the European Union we have an agreement on GMP guidelines for herbal medicine programs. We have an agreement with the European Union on quality criteria.

Just a few days ago we had European marketing authorization for valerian root. It was a commercial product that got licensing at the same time as many countries in Europe did. So the system does work for herbal medicine products in Europe and for homeopathic products as well. We have directives and standards in the European pharmacopoeia. We have European directives with criteria for the tests on the homeopathic products. I'm quite optimistic that harmonization is possible—in Europe, at least.

What could we do better if we had to do it again? I think it's very important to offer the consumer a choice, to make the product available. At the same time, it's necessary to have control of the quality of products on the market. It is necessary to know which products are on the national market and to have the possibility to take action if you find out, for example, something like aristolochia.

What could be improved, in my opinion, is the control of the assessment of consumer protection from all those products that are not industry-prepared finished products. There are very few controls on stopping materials—drugs, for example, sold in kilograms—that are not pre-packed and distributed directly to the consumer.

We think there should be some mechanism for control. We could imagine some publicly available standards or some type of monograph system that could be used to inform the consumer on such products that are not industrially prepared.

One experience we have seen in Europe is that if an agency is too strict—for example, with herbal products—this will add to the risk for the consumer, because the consumer would have access to herbal medicine and other comparable drugs.

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For example, all herbs can be collected in the field. If this is done, there is a big danger that the wrong herb is collected and so on. You may get bad quality. So again, the best way to protect consumers is to make such products of quality and with adequate labelling available to the public. We think this should be done in all countries.

The Vice-Chair (Mr. Reed Elley): Thank you very much, Dr. Keller.

We allowed double the time for the question because I believe it was such an important question.

We're getting close to the end of our meeting here today. I'd just like to ask the committee members—I know Mr. Dumas has a question—if anyone else wants to pose a question before we close our meeting?

[Translation]

Mr. Dumas, please.

Mr. Maurice Dumas: The quality of medicinal plants varies from year to year depending on soil quality, amount of sunshine and water. How can you control that quality in terms of dosage?

[English]

Ms. Laurayne Bowler: At the moment that is not measured in Australia. There is a move toward standardization of herbal products. This has certain advantages as well as disadvantages.

On the standardization, we don't know sometimes whether it is to something that is meaningful. With some of the marker substances, we're not sure whether they in fact relate to the therapeutic activity of the product. While in theory it sounds as if it's a good idea, in practice it's probably not necessarily going to improve the standard, although we'd like to encourage moves that would.

If we can actually get a history of the product, or if we can be sure the product to which they are standardizing it really is meaningful, we would like to encourage that. It's early in the day, and it's not something we have explored in great depth in Australia, except to flag the problems.

Our dosage is largely related to the dry weight or the fresh weight of the original herb. We know that is not a terribly accurate measurement sometimes because, as you have said, these products can be collected in different soil conditions and types at different times of the year, and that can affect very much the level of activity in the plant.

Mr. Richard Woodfield: This is not an issue we've addressed significantly so far, in relation to unlicensed herbal remedies. We do have some concerns that if arrangements are too sophisticated and demanding, they could in effect serve to drive out from the marketplace altogether some of the herbal products of ethnic origin in various parts of the world.

Having said that, obviously we must protect the public. Really this is one of the issues we now have to address in more depth in the Medicines Control Agency. I'm speculating here, but I think we would wish to concentrate on those aspects of quality that relate primarily to safety, for example, whether the product is contaminated, rather than those that relate to efficacy. Bearing in mind unlicensed herbal products in the United Kingdom are not required to prove their efficacy, we think the prime target should be to concentrate on safety issues. If the public wishes to buy things that are of unproved efficacy, that's fine as long as they're safe.

The Vice-Chair (Mr. Reed Elley): Dr. Keller.

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Dr. Konstantin Keller: I would say again that we have realistic standards in the European pharmacopoeia. We have nearly 100 small drugs in the European pharmacopoeia, and these small drugs are not drafted from a sharp academic viewpoint but are drafted with input from industry, so they really give a realistic criteria for good quality of herbal drug.

It was very important for us to have adequate quality criteria for herbal drug preparation in Europe. You probably have access to our guidelines on quality testing of herbal drugs. We address all these different problems of how to collect the herb and how the drying is done.

As for the future, we already have draft data from the international Society for Medicinal Plant Research that agricultural production of medicinal herbs will be one focus. There are guidelines from the scientific community that are going to be prepared on how to cultivate medicinal herbs.

I think the wide collection of medicinal herbs as it is done actually will be more and more difficult, because it's a question of preserving natural resources in the countries the herbs are coming from. I think agricultural production of medicinal herbs will become more and more important. I don't think the quality criteria for herbal drugs can be tested in the drug; they have to be produced in the product, and this includes agricultural production as well.

The Vice-Chair (Mr. Reed Elley): Thank you very much.

There is one last question that has come to us from our researchers, if you could comment briefly on this. What do you think of the approach of our friends in the United States and their DSHEA legislation? Would someone like to comment on that?

Mr. Richard Woodfield: I'm afraid I'm not familiar with the legislation.

Ms. Laurayne Bowler: It causes us a lot of concern in Australia, because we have a lot of pressure, particularly with the dietary supplements, with products that are extracted from foods—that we should approve these products because they're on the market in the U.S.

Our concern is to establish what is the substance that is in the product and then to look at whether or not there is a history of safety. Under this new approach that we're taking with the complementary medicines evaluation committee, that is precisely what we will be doing, and we will be looking at some of those dietary supplements that are on the market in the U.S., if there is evidence there, to establish exactly what the substance is that is in the product, and then to establish the claims they wish to make, although having looked at the U.S. legislation the claims that are permitted seem to be much more restrictive than the products that we actually see being imported into Australia, so I'm not sure what the level of compliance is there. That I think is perhaps not well understood by our industry—that they don't in fact comply.

The Vice-Chair (Mr. Reed Elley): Thank you.

Dr. Keller.

Dr. Konstantin Keller: We don't have any experience with the U.S. legislation.

The Vice-Chair (Mr. Reed Elley): Thank you very much.

That will bring to a close this portion of our meeting today. Once again, on behalf of the committee, I want to thank all of you for appearing before us today, particularly for those of you who have gone through jet lag and time zones and are here. Thank you so much for coming. Dr. Keller, thank you for joining us from Germany. We're sorry you couldn't come to our wonderful country, but we hope you will at some point. For our own people from Health Canada, thank you for coming too.

We'll take a short recess so that we can get all of the video connections taken care of and then we will resume our meeting with the rest of our agenda. Thank you very much.

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• 1157

The Vice-Chair (Mr. Reed Elley): I call the committee back to order. We'll get on with the short agenda that we now have to deal with.

I believe Mr. Myers has a motion he would like to introduce to the committee at this time.

Mr. Lynn Myers: Thank you, Mr. Chairman.

I understand the member from Esquimalt—Juan de Fuca has filed an objection with the official languages commissioner based on his ability to present a motion he had, and I think that's probably coming up later today. It was in English only, you'll recall, at the May 5 meeting.

Certainly I understand the rules of the House and the committee with respect to that, and I understand that can happen. Therefore it seems appropriate that the request be made—and I'd be prepared to make the motion—that all motions presented to the committee made in both official languages be rescinded.

Specifically to that, if I have the concurrence of the committee, I would move that the motion concerning official language use in committee, adopted May 5, be rescinded.

[Translation]

In French, Mr. Chairman, I move that the motion concerning official languages used in committee, adopted May 5, be rescinded.

[English]

I want to put my own observation on this, if I could. I certainly respect the fact that the rules suggest and in fact are in place that allow it to be in one official language only. However, in other committees, out of courtesy and I think with sensitivity, we ensure that the motions presented are in both official languages.

It seems to me too, by way of observation, that to press on in this issue and make it into something larger than it is lacks sensitivity and lacks a basic understanding of the duality of this country of ours. But having said that, while it saddens me, it certainly comes as no surprise that the Reform is doing this. I guess in that sense it's understandable. However, it saddens me in that regard.

Having said that and made those observations, I would ask that the motion be rescinded.

The Vice-Chair (Mr. Reed Elley): Would members like to speak to the motion?

Mr. Martin.

[Translation]

Mr. Keith Martin (Esquimalt—Juan de Fuca, Réf.): Thank you very much, Mr. Chairman. I would support Mr. Myers' motion

[English]

if and only if the motion is rescinded, but the context of the debate of this motion is presented to the House in the form of a document.

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I'd also like to add my own personal touch to this. The circumstances that took place in that committee were affected by history and certain overtones that have taken place for some time. Mr. Myers was not here for the last Parliament. This is his first Parliament, and he doesn't understand that in most committees, as in this one, most members try their best to put forth motions in both official languages, regardless of what party they come from, for the reasons the member mentioned.

Sometimes that is not possible, and I bring to mind the intention of Mr. Myers that the original motion he put forward on the language issue was put forth in only one language, and that was in English, and he should remember that. We all try to put forth motions in both languages in consideration of the duality of this country and the fact that we have two official languages, which the Reform Party is well aware of.

In closing, I would just like to say I would certainly be agreeable with the motion of Mr. Myers if, and only if, the committee decides to put forth, in the form of a document that's tabled in the House of Commons, the circumstances around which the motion was put forth and the conclusion of this whole little debate. Then we can get on to the real meat of the matter, which is to discuss organ donations.

Thank you.

The Vice-Chair (Mr. Reed Elley): Mr. Martin, are you making this in the form of an amendment to Mr. Myers' motion?

Mr. Keith Martin: Yes, this would be in the form of an amendment to Mr. Myers' motion, that the motion be rescinded but the debate taking place on the motion and the outcome of Mr. Myers' motion and his second motion be tabled in the House of Commons. Then we can waive the 48-hour time period that's required to table motions in committee.

The Vice-Chair (Mr. Reed Elley): The clerk is suggesting that when this goes to the House of Commons it will already be in the form of a transcript and it wouldn't be necessary to table another document. It would already be there.

Mr. Keith Martin: Perhaps the clerk can clarify something for me. If the transcripts are tabled in the House, will members have an opportunity to speak to them in the House?

The Clerk of the Committee: Transcripts of committee meetings are automatically part of the House deliberations. As such, they aren't tabled in the House. To your second question, yes, members can address in the House deliberations that have taken place in committee. The form you do so belongs to you, though.

Mr. Keith Martin: Okay. So do we need a concurrence motion for our amended motions in order for that to happen?

The Vice-Chair (Mr. Reed Elley): Mr. Martin, you would have to specify what document you are asking to be tabled in the House before we ask concurrence.

Mr. Keith Martin: I'd like to have the outcome of this little debate on this motion, with respect to the language issue, tabled in the House of Commons in the form of a document. Under those circumstances, members will have an opportunity to speak to it in the House.

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If I may say something else, if we put this little debate in the form of a report and that report is tabled in the House, then members will have an opportunity to speak to it in the House. And that's what I'd like to happen.

The Vice-Chair (Mr. Reed Elley): My understanding is that when the minutes of this meeting are put forward they become the official document of this meeting and any member can then stand up and, through a point of order or a point of privilege, I guess, speak to the document, the official transcript. What I'm wondering about is whether your motion is necessary if there is this method of doing it.

Mr. Keith Martin: I'm not sure that one has the chance. My understanding of it is that you need a concurrence motion in order to have this report tabled in the House so that members can speak to the debate within this committee in the House.

The Vice-Chair (Mr. Reed Elley): All right, let's clear this up. It sounds like you're speaking about an official report on this incident to the House, whereby we would present this and members would then have an opportunity to speak to it.

Mr. Keith Martin: That's correct.

The Vice-Chair (Mr. Reed Elley): So now you're asking that an amendment be made to Mr. Myers' motion, and we need concurrence for you to have that amendment put.

Mr. Keith Martin: That's correct.

The Vice-Chair (Mr. Reed Elley): All right. Let's get on with this then.

Mr. Keith Martin: And then I'd agree with Mr. Myers' motion.

The Vice-Chair (Mr. Reed Elley): Mr. Volpe, speaking to the amendment.

Mr. Joseph Volpe: I have just a couple of observations, Mr Chair. First of all, I think the intention of the mover, Mr. Myers, simply to withdraw a motion that was passed in the last meeting, is that he is looking for unanimous consent in order to present that motion. That's what we're talking about: unanimous consent to present that motion without the 48-hour notice.

Given that such is the intention, I think we have to address the issue of whether we want to give him unanimous consent to do that. If we have that unanimous consent, then we can go on to the motion itself. If we then want to discuss Mr. Martin's amendment, I think we have to consider whether it is in order.

That having been said, Mr. Chair, I think the foremost issue at present for the committee to consider is whether we want to move on to the substantive health issues or whether we want to take much more time to deal with an issue that the initial mover has already said is an unfortunate part of the by-product of the debates that take place in any environment.

A debate, Mr. Chair, that is continuing today can continue in the House at any time a member wants to raise it. This has already received the attention of both the Speaker and the official languages commissioner. Both of those latter two will be providing the kind of “documentation” that Mr. Martin would like to see from this committee and which I think this committee is not in a position to consider or to prepare or to advance, because its limits are always part of Hansard and therefore are a reference point for the House, as the clerk has indicated, at all times.

Mr. Chair, yes, I think it's important for us to keep in mind that we try to cooperate, even in a partisan environment. Mr. Myers, it is true, has been a member here since the last election. Mr. Martin was a member of this committee prior to the last election, and so the dynamics to which he refers are those which he entered into last week. This committee, I think, was very responsive to the insertion of a new member who had a specific health concern—and we are still, I think, in that mode.

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I would prefer—and I'm speaking singularly here—that we not dwell upon the dynamics brought by one member prior to the last election or by another member after the last election, but that we concern ourselves with the intent of both members as per the motions that were before us last week, i.e., the substantive health one and, secondly, the one that is being withdrawn.

I urge you, Mr. Chair, to just simply reflect on the first couple of phrases of my preamble and ask the committee if there is unanimous concurrence to present the motion and then to deal with the motion so that we can deal with Mr. Martin's substantive health issue.

The Vice-Chair (Mr. Reed Elley): Thank you very much, Mr. Volpe.

In the interests of time and of the greater health concerns we have here, I think we should move on with this, so I will ask if there is unanimous consent for Mr. Myers to put his motion. Is that agreed?

Some hon. members: Agreed.

The Vice-Chair (Mr. Reed Elley): All right. Then we must deal with Mr. Martin's amendment to the motion, and we need to have....

[Translation]

Mr. Dumas.

Mr. Maurice Dumas: Mr. Chairman, I wasn't here when all this happened. I see that Mr. Martin's motion was given to us in both official languages. Before we vote, I would like to understand a number of things.

[English]

The Vice-Chair (Mr. Reed Elley): Yes. It's very difficult to go back and be accurate in a blow-by-blow description of what happened several days ago, but I think it's fair to say that Mr. Martin asked to appear before this committee to put forth a motion concerning a private member's bill that was supported in the House, and he wishes to have the minister and officials of Health Canada discuss this bill in committee.

When he came here, he did not have the motion in both official languages, but unfortunately at that point, in the heat of the debate, a decision was made by the committee and a motion was passed to have that put in both official languages before it could be placed before the committee.

In retrospect, getting a ruling from the official languages commissioner was not needed. A member can come here and put it in his own language, because of the translation services available at the committee level, so that any member can hear the motion in his or her own language.

So now we're at a stage where we want to rescind a motion that was made last week and move on from there to get to the really substantive part of the debate in terms of organ donation. That's where we're at.

I hope that was accurate. I'm going to put the motion as amended before the committee and have you vote on the amendment.

Mr. Joseph Volpe: Mr. Chairman, on a point of order, does Mr. Martin still want to introduce his amendment?

Mr. Keith Martin: Yes, the amendment stands as is.

Mr. Joseph Volpe: Is it in order?

The Vice-Chair (Mr. Reed Elley): I think it's best to call the question and let the committee decide.

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Does everyone understand the motion as amended? Do we have a clear understanding of that so we know what we're voting on?

Mr. Joseph Volpe: We're voting on the amendment.

The Vice-Chair (Mr. Reed Elley): We're voting on the amendment at this point, not that motion.

(Amendment negatived)

The Vice-Chair (Mr. Reed Elley): Now we'll go back to the original motion, which Mr. Myers has already placed before us.

Mr. Keith Martin: The Official Languages Commission is going to put forth a report. The Speaker is going to put forth a report. However, if we adopt Mr. Myers' motion to rescind, does that negate the activities of the Speaker and the Official Languages Commission?

The Vice-Chair (Mr. Reed Elley): No, my understanding is, by doing that, that does not stop what the official languages commissioner has already put into motion. He can only stop that himself.

Now we'll vote on Mr. Myers' motion.

(Motion agreed to)

The Vice-Chair (Mr. Reed Elley): We will go to the next item, which is the introduction of Mr. Martin's motion, that the health committee invite the health minister and Health Canada officials to appear before the committee to respond to questions relating to Bill M-222 and report on progress made in the area of organ transplantation since the unanimous adoption of Bill M-222 in the House of Commons on October 9, 1997.

Would someone like to speak to the motion?

Mr. Martin.

Mr. Keith Martin: Merci beaucoup, monsieur le président. Since October 9, 1997, when this motion was passed, we have not seemed to be able to get any action from the health minister.

For some 15 to 20 years, the issue of organ transplantation, and ways in which to improve it, have gone around and around in a circle, and any efforts have really stayed in legislative purgatory. The motion is an effort to break that cycle, to be able to improve the organ donor system within our country, to save lives, to save money, to save the pain and suffering endured by so many individuals who are waiting for organ transplants in this country.

Approximately 130 people die every year waiting for organ transplants. This is an avoidable tragedy. Canada has one of the lowest donor rates of the entire western world, and I think that's an embarrassment to us and we need to deal with it.

If we take our crystal ball and look into the future, we see what is happening is that there is a growing disparity between the number of organs that are available for transplant and the number of people who are waiting for transplants. Between 1991 and 1995, while there was a 16% increase in growth in the number of transplants that were done, there was a 40% increase in the number of individuals waiting for transplants, and the situation is only going to get worse.

The humanitarian aspects are obvious; the financial aspects, perhaps less so. If you look at kidney transplants, the cost of doing a kidney transplant, with the medications and treatment involved in that over a five-year period of time, runs around $ 50,000. The cost to put somebody on dialysis for five years is $ 250,000. The mathematics are quite evident.

The motion really involves four points, which are as follows.

The first one calls for a real-time database that links donors with potential recipients. We're one of the only countries in the western world that does not have a national database that links up donors with potential recipients. This would greatly improve the ability of our transplant teams throughout the country to get access to those organs and find the best matches for those patients requiring organ transplants. It would be enormously helpful to have that.

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The second point calls for a mandated choice strategy. For example, on your tax forms you'd have an option of saying, “Yes, I would like to be an organ donor” or “No, I would not like to be an organ donor”. Doing it through the income tax is a very useful way, because we all sign off on our income tax every year. That would access a whole lot more people and explicitly give them the choice as to whether or not to be organ donors. Where that has been done, it greatly increases the number of organs that are available for transplant. In a recent poll, 77% of Canadians indicate their willingness to donate organs, which is very important.

It also decreases the stress on families. If the family knows very explicitly the wishes of their loved one who has passed away—and this question of course is asked under the most trying and difficult of circumstances anybody could imagine—it takes the stress off them, because they know the wishes of their loved one.

The Vice-Chair (Mr. Reed Elley): Mr. Martin, I know this is a very important topic to you. I'm wondering if you could talk mainly on the motion that is before us here and tell us why you would like to have the minister come in.

Mr. Keith Martin: Okay.

I'll briefly finish the last two points, on the removal of financial disincentives—and Quebec has been a leader in doing that, which has greatly improved organ donors—and on giving legal benefit to those who mark off on their organ donor forms that they would like to consent.

In any event, the motion I put forward, Mr. Chairman, and my reason for being here, is to call the health minister in front of this committee so all of us as members of the committee can ask the health minister what he has done and what his department is doing. To date I have been absolutely unable to get any movement from the minister or the department. It is that simple. I want to break the glass ceiling on the issue.

The Vice-Chair (Mr. Reed Elley): Thank you very much.

Mr. Volpe.

Mr. Joseph Volpe: Mr. Chairman, this is an indication of some of the very productive dialogue that can take place when members put their partisanship aside. I want to compliment my colleague opposite. He went beyond the preamble, where he admittedly and legitimately used language that was in part partisan, and he went into the substance of an issue with which we have great affinity.

I want to compliment him on raising the matter. I want to compliment him as well on bringing the issues in a detailed format. I want to assure him that we on this side of both the committee and the House are very much aware of the gravity, the seriousness, of the issue and of the reliance that the Canadian public—potential patients and others—have on a very strong volunteer base. We're most desirous, as he knows quite well, both from our intervention and from our action, of improving the size of the volunteer base, and we look forward to an opportunity to share that kind of initiative with him.

All I can say is I support his motion, and judging from my colleagues on this side of the House who have left me with the delegation to speak on their behalf, I can tell you that at least as far as we're concerned, he'd have our unanimous support.

The Vice-Chair (Mr. Reed Elley): All right. Shall we put the motion then?

(Motion agreed to)

The Vice-Chair (Mr. Reed Elley): We will instruct our clerk to please inform the minister and see when we can arrange this to take place. Thank you very much.

We have just one last item dealing with a budget submission. We've run out of money on this committee, so we are asking for a new supplementary budget submission that totals $ 50,000. Do we need a motion for this? Would someone like to make a motion to approve the supplementary budget submission?

Mr. Maurice Vellacott: I have a question with respect to the last vote. Was there a quorum?

Mr. Joseph Volpe: There was a quorum as we began debate on the matter, and I think you ought to rule that the quorum was here, even if some people voted by proxy.

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The Vice-Chair (Mr. Reed Elley): The clerk has said the minutes will reflect that there was a quorum present when this motion was originally tabled and that it was under the agreement of the quorum at the present time that this motion be adopted.

We will go back to the other motion on the budget submission.

(Motion agreed to)

The Vice-Chair (Mr. Reed Elley): Thank you very much. The meeting is adjourned.