HEAL Committee Meeting

STANDING COMMITTEE ON HEALTH

COMITÉ PERMANENT DE LA SANTÉ

EVIDENCE

[Recorded by Electronic Apparatus]

Wednesday, December 2, 1997

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[English]

The Chair (Ms. Beth Phinney (Hamilton Mountain, Lib.)): I call the meeting to order. This is the eighth meeting of the Standing Committee on Health.

Today we're going to continue on with the department, which is helping us to get informed about what is going on in their department in this area.

I'll ask Dann Michols to introduce the people who will be our first witnesses today.

Mr. Dann Michols (Director General, Therapeutic Products Program, Department of Health): Thank you, Madam Chair.

I have just a quick comment. Additional material has been prepared for the binders we passed out last week. In response to the questions that were raised by Ms. Carroll just at the end of our presentation, we produced three briefing notes on the subjects on which she wanted further information. These are being handed out together with a reworked version of the table of contents, which shows those three notes. Those three notes are tabs 40, 41, and 42 for the binder we passed out before.

Just to reintroduce myself, I am Dann Michols, director general of the therapeutic products program. With me today is Mary Carman, who is the director of the bureau of pharmaceutical assessment. Jean Lambert is responsible for the compliance and enforcement operations within the therapeutics products program.

We presented to you last week. There were a number of questions that came up about activities within the food directorate, so I'd like to introduce Dr. Harry Conacher, who is the acting director of the bureau of chemical safety within the food directorate. He has a short presentation to give you on the regulatory activities of the food directorate as they relate to herbs and botanicals and such. Then we would be delighted to answer any questions you have, either on the therapeutic side or on the food side.

Perhaps Dr. Conacher will introduce his staff.

The Chair: If I could just interrupt, I haven't mentioned to the committee that we're going to do about 10 or 15 minutes on the foods, then we'll open the floor to questions on everything we had last week and on the presentation of the first 15 minutes.

Dr. Harry Conacher (Director, Bureau of Chemical Safety, Department of Health): Thank you Dann. Thank you, Madam Chairman.

Ladies and gentlemen, we're pleased to have this opportunity to present the position of the food directorate on the subject of herbs and botanicals.

With me today is Mr. Ron Burke, who is the acting director of the bureau of food regulatory, international and interagency affairs. Mr. John Salminen heads the group within the bureau of chemical safety that conducts the risk assessments on herbs and botanicals.

Although most of what we plan to say this morning is summarized in tabs 35 through 39 of the binder that was distributed last Thursday, we also distributed some additional notes that we will talk to. I hope everyone has a copy of those notes.

In our presentation today, we propose to say a little about the food directorate, what it is, and what its role is. We want to say a little bit about the status of herbs and botanicals as foods. We want to give some details about schedule 705, its development, and where it stands at present. Finally and hopefully, we'll clarify some of the issues surrounding the Codex initiatives.

Turn to page 3 of the package that was distributed, assuming you all have this package. The food directorate is a program directorate of the health protection branch, as is the therapeutic products program, which Dann looks after. He presented to you last Thursday.

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The food directorate's mandate, in general terms, is to ensure a safe and nutritious food supply. It does this under the regulatory authority of the Food and Drugs Act and regulations.

I will try to take you very quickly through the information I've distributed. Page 3 is entitled “Food Directorate”. The food directorate is a directorate of the health protection branch. Its mandate is to ensure a safe and nutritious food supply. It operates under the regulatory authority of the Food and Drugs Act and regulations.

Page 4 is entitled “Food Directorate Involvement”, meaning in the area of herbs and botanicals. It's conducted primarily in three bureaus: the bureau of chemical safety, which is my bureau, where we assess chemical substances in foods sold in Canada; the bureau of nutritional sciences, who concern themselves with nutritional aspects; and the bureau of food regulatory, international and interagency affairs, where we talk about international regulations, such as Codex.

Ms. Elinor Caplan (Thornhill, Lib.): Can you tell us what “Codex” means?

Dr. Harry Conacher: My colleague will be describing Codex and its activities in the presentation following mine.

Ms. Elinor Caplan: But what does it stand for?

Mr. Ron Burke (Acting Director, Bureau of Food Regulatory, International and Interagency Affairs, Food Directorate, Department of Health): It stands for “Codex Alimentarius Commission”.

Ms. Elinor Caplan: Okay, forget it.

The Chair: We'll get to it later.

Dr. Harry Conacher: I'd now like to say a few words about herbs and botanicals and their status as foods. That's on page 5 of the package you have.

First of all, there are no formal pre-clearance requirements for herbs and botanicals as foods as compared with drugs, or indeed, for that matter, pesticides and food additives, where stringent pre-clearance requirements are in place.

Having said that, however, we are often asked by manufacturers and vendors of herbs and botanicals for opinions as to the safety of these products. We conduct a health hazard assessment of the product as best we can with the limited information we have available.

Secondly, when those products are sold as foods, health claims may not be made under the current regulations. The onus is on the vendor to sell a safe product, and we, as the government, may make regulations to prohibit the sale of hazardous substances. It was this final point that led to schedule 705 in the first place.

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First, what is schedule 705? In its present form, and it has undergone many changes over the years, it comprises a list of herbs and botanicals that may not be sold as foods. It also comprises a short list of herbs and botanicals that may be sold as foods with certain restrictions. It also comprises a short list of herbs that may be used as flavourings. The fact that the substance is on schedule 705—and this is a point that leads to a lot of misunderstanding—does not necessarily preclude its use as a drug where benefit-risk considerations come into play, as Dann described last Thursday, and where its sale as a drug can be better controlled. That is one point. At present, schedule 705 has no regulatory status. No regulations have been promulgated in connection with schedule 705.

I would now like to briefly outline in chronological order in the next two or three pages how schedule 705 was developed and where it stands at present. You will note the extensive consultation involved in the development of this schedule. In the early 1980s the trend towards increasing use of herbs and botanicals was already apparent. At the same time there were very few traditional toxological studies available to us on which to assess the safety of these substances. There was information available in the literature as well, though, that indicated that some of these compounds would not be appropriate for sale as foods because of the presence of toxic or potentially toxic constituents.

Also at that time, in the early 1980s, our expertise in this whole area was somewhat limited.

With all that as background, the first expert advisory committee was established. It was established to give us some advice as to how we might proceed and how we might regulate in this area. The expert advisory committee reported in 1985, coming up with a negative list of herbs and botanicals, that is, a list of herbs and botanicals that were unsuitable for use as foods. They also came up with some other categories acceptable under certain conditions. This series of recommendations then led to expensive consultations with all stakeholders—not just experts but with all stakeholders—resulting in subsequent modification to this negative list developed by the expert committee. This modified list formed the basis of schedule 705 in the Canada Gazette, part I, in 1989. So that is how schedule 705 came about.

During the period 1989 to 1992, schedule 705 was further revised based on further comments received in connection with publication in the Canada Gazette, part I. These comments were primarily from trade associations regarding the traditional use of some of these substances as flavourants in their products. An additional table was included in schedule 705 based on this input. This revised schedule 705 was republished in 1992 in the Canada Gazette, part I, again. The reason we went to part I again was because of the changes that had occurred from the first schedule 705 and because of the time that had elapsed; the three-year period between the first publication and this one.

Following the publication of the revised schedule, unlike for the 1989 publication, a very large and very angry response was received primarily relating to freedom of choice issues and the restrictions these regulations would place on the availability of these herbal products. Because of these, and because of other objections received in connection with the second publication, and because the negative list had expanded considerably during that time period—it had almost doubled from something like 33 compounds to almost 64—we established the expert advisory committee again in order to reassess the situation. In essence, what the expert advisory committee told us at that time was that it essentially reaffirmed support—this is on the next page—for this schedule 705, with a few modifications.

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The Chair: Excuse me, but are you on the year 1992 now? Is that the page you're on?

Dr. Harry Conacher: Yes, 1992-93.

The Chair: Okay.

Dr. Harry Conacher: On that, we reconvened the expert advisory committee. The advisory committee reconfirmed support for the revamped schedule 705, with a few modifications. From then on, the public opposition to schedule 705 has continued unabated. It has been expressed by way of letters to the minister, numerous form letters to the minister, and petitions. That has continued since 1993. So in the face of such opposition we have had to rethink our whole position on schedule 705.

What really is the reason for this ongoing opposition? We think it's a combination of a greater awareness of the issue as a result of all of the consultations that have been and were occurring, both through the food directorate and through the therapeutic products directorate.... It should be pointed out, however, that this prohibited list of herbs and botanicals in schedule 705 was only intended to restrict the sale of certain herbs and botanicals as foods. They certainly could still be made available as drugs, assuming the drug requirements were met, of course.

It seemed to us that we would really have to look much more closely at other ways of handling this issue—for example, consumer education. The main problem with consumer education, as far as we were concerned, however, was keeping it up on an ongoing basis. It's not an easy thing to keep up.

It certainly seemed that another round of consultations was essential to clarifying this whole situation with regard to schedule 705 and to seeking solutions that would provide this freedom of choice while at the same time ensuring that products were not out there that would harm the consumer. These consultations would have to involve all stakeholders, not just the expert advisory committees we had involved.

These consultations are under way to a certain extent right now through the initiative on herbal remedies that is being conducted by Dann's therapeutic products directorate; through the functional foods nutraceuticals initiative, which is being jointly handled by the therapeutics directorate and the food directorate; and also, now, this committee inquiry.

I hope that in this brief time I've given you an indication of how 705 was developed and where it stands at the moment. I would now like to turn the podium over to my colleague, Mr. Ron Burke, who will tell us about the Codex initiative, which has also led to a lot of misunderstanding.

Mr. Ron Burke: Thank you, Harry.

Good morning. There are two issues being addressed by the Codex Alimentarius Commission that are of relevance to the standing committee's study of natural health products. These are our draft guidelines on vitamin and mineral supplements and a list of potentially harmful herbs and botanical preparations. These are being considered by a particular Codex committee, the Codex Committee on Nutrition and Foods for Special Dietary Uses.

Under tab 37 of your book you have a briefing on this subject, but I'd like to run through some of the major issues to clarify some of the concerns about the Codex. Clearly, there have been hundreds, if not thousands, of Canadians over the last year who have been very uneasy about these two issues being addressed by the Codex and the potential impact of the Codex work on the availability of products within Canada.

If you turn to the second sheet on your “Codex Alimentarius”—part 2 of the hand out that was given to you—you have a brief description of what the Codex Alimentarius Commission is. It's a subsidiary body of the Food and Agricultural Organization of the United Nations and the World Health Organization. It was established in 1962 to implement the joint FAO-WHO food standards program.

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If you turn to the next page, you'll see the three objectives of Codex. One is to protect the health of consumers; two is to ensure fair practices in food trade at the international level; and three is to co-ordinate all food standards work, once again at the international level.

If you turn to the next sheet, it indicates where the Codex Secretariat is. It's located in the FAO offices headquarters in Rome, Italy. The chief of the food standards program, or the chief of Codex, is Mr. Greg Orriss, and that may be of interest to you because Greg is a Canadian. He assumed this position about 16 months ago. Before that he was an official with Health Canada in the western region, based in the Kelowna area.

If you turn to the next page, you'll see the size of Codex and its importance at the international level. There is a total of 159 member countries within Codex, representing about 98% of the population of the world. In addition to the 159 member countries that participate in Codex, there is a large number of observer organizations at the international level representing consumers, food industry, trade, and scientific associations.

The Chair: Can I just interrupt for a moment? I'm going back to Elinor's question of what Codex is. On this page you're saying there are 159 members of Codex.

Mr. Ron Burke: That's right.

The Chair: Does Codex not mean food law? That's what you have here.

Mr. Ron Burke: Yes, that's the first page.

The Chair: So is it the 159 members within the commission that is called the Codex commission? We don't know what you're talking about, so we want to get this narrowed down.

Mr. Ron Burke: Okay.

The Chair: So the title of it is the Codex commission. Is that right?

Mr. Ron Burke: Codex Alimentarius Commission is the title of the organization.

The Chair: Rose-Marie.

Mrs. Rose-Marie Ur (Lambton—Kent—Middlesex, Lib.): Madame Chair, if we turn to tab 37, as the presenter has instructed us, perhaps we should be reviewing that to enlighten the committee, because it has a really good description. Everyone seems to be concerned about Codex and it's being referred to as a.... I'm not telling the department what to do, but I think we can talk about Codex, and if we don't know what we're talking about here, translate this.

The Chair: Right. You sort of skipped over the page where it says what Codex is, and somebody had already mentioned it.

Mr. Ron Burke: Oh, I'm sorry.

The Chair: Maybe you could do that on page 37. I don't know, I don't have it here, but perhaps that's a better explanation. We don't understand what you mean by Codex. Does that mean food law or is that the name of a committee?

Mr. Ron Burke: Codex Alimentarius is Latin for “food law”. I was just trying to give you an idea of what the term meant, because Codex Alimentarius as such really doesn't mean anything to anybody.

The Chair: When you say Codex, what do you mean?

Mr. Ron Burke: When I say Codex, I'm talking about the Codex Alimentarius Commission, which is the organization that's jointly operated by the Food and Agriculture Organization of the United Nations and the World Health Organization.

The Chair: Okay. Is that clear?

Ms. Elinor Caplan: It was the researcher who pointed this out. Its purpose is to ensure safe practices in the food trade and to facilitate international trade in food and food products, and Canada is one of the 151 members.

Mr. Ron Burke: That's right. It's 159 members. It keeps growing.

Ms. Elinor Caplan: Okay, we're up to 159.

The Chair: Sorry we interrupted you, but I knew there was some confusion about that.

Mr. Ron Burke: Okay. I'm not sure which page you're on, and unfortunately these aren't numbered.

The Chair: It's the one that says at the top in big letters....

Mr. Ron Burke: Okay. The top page I have at the moment is the Codex Alimentarius Commission, which indicates the size of the commission plus participation in Codex committee sessions by observer international organizations representing a variety of stakeholders.

If you turn to the next page entitled “Codex Committees”, this gives you an indication of how Codex operates. It operates on the basis of eight general subject committees, like food labelling or food additives and contaminants. These are sometimes referred to as horizontal committees because they deal with issues across the spectrum of food products. Then you have 14 commodity committees, which deal with individual products, such as fish and fishery products, fruits and vegetables, milk and milk products. Then there are regional committees that try to co-ordinate activities of Codex within the various regions of the world, such as Asia and Africa and North America.

On the next two pages entitled “Codex”, I won't go through these, but this indicates the steps Codex goes through in the development of the various standards and guidelines and recommendations. They're simply for reference purposes for you, particularly later on when I discuss the guidelines in vitamin and mineral supplements. So we'll keep over those two pages.

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I'll move to the next page, which is on Codex standards and related texts. This gives you an idea of the volume of work Codex has developed in the last 35 years: more than 200 commodity food standards. It has developed approximately 40 hygienic and technological codes of practice. It has established approximately 3,000 maximum-residue limits for pesticides. It has evaluated the safety of over 1,000 pesticides, food additives, contaminants, and veterinary drugs.

I won't go through the next two pages in detail. They are there for your reference. They indicate how Canada's participation in Codex is organized, first of all through the Codex contact point within Health Canada, then through an interdepartmental committee on Codex, which is comprised of officials of Agriculture and Agri-Food Canada, the Canadian Food Inspection Agency, Foreign Affairs and International Trade, Health Canada, and the Pest Management Regulatory Agency.

In view of the time, I'll skip over the next page, about the Codex contact point for Canada. It indicates what they do.

This next page, on the relationship between Codex and the World Trade Organization, is important because of the controversy that has surrounded Codex within the last year. First of all, Codex texts within the Codex program are elaborated for voluntary adoption by countries. The intention is that Codex develops these international standards through consensus of the participating governments. Then one hopes governments would adopt these standards and having uniform standards around the world would facilitate trade. There's no requirement for governments to accept Codex standards. It's purely on a voluntary basis.

The important issue, and perhaps the source of so much of the controversy about Codex in this last year, is this next point, which indicates that Codex text is used as reference points by the World Trade Organization for resolving trade disputes when countries set higher standards than Codex. In other words, Codex is the reference point in trade disputes. If a country develops a standard that is more stringent than Codex and a trade complaint is lodged by a trading partner, then the country is required to provide a justification for having a requirement that is more stringent than Codex. If you are less stringent than Codex, clearly there's no concern. If you adopt the Codex standard you are deemed to have met your obligations under the WTO, but if you adopt a standard that's more stringent than Codex and that impedes trade and a complaint is lodged—and that's important; it has to be a complaint lodged by a trading partner—then you could be required to justify your higher standard.

I want to move now to the two issues of interest to this particular committee, the ones I mentioned earlier. These two issues are being addressed by the Codex Committee on Nutrition and Foods for Special Dietary Uses. The host country for this committee is the Federal Republic of Germany, and the last session of this committee was in October 1996.

The first issue that has caused some controversy is the proposed draft guidelines for vitamin and mineral supplements. These draft guidelines were originally prepared by the Government of the Federal Republic of Germany. They are intended to address increasing international trade in vitamin and mineral supplements. By this we are talking about vitamin and mineral pills and capsules, the one-a-day multiple vitamins—that type of product—sold routinely in pharmacies and considered to be drugs in Canada.

That's the important issue: that these guidelines do not apply in countries, and are not intended to apply in countries, where vitamin and mineral supplements are regulated as drugs. That's the case in Canada. Therefore these guidelines have no application in Canada.

There has been considerable concern in certain segments of the Canadian population that if these guidelines were adopted by Codex and were more stringent than Canadian requirements...there was a belief there was some kind of obligation on behalf of Canada to adopt these guidelines and that could perhaps result in a lot of products being taken off Canadian shelves. That is simply not the case. There is no obligation on Canada to accept these guidelines, first of all. Secondly, since they are not intended for countries that regulate these products as drugs, there's no application at all to Canada.

At the last session, in October of 1996, the nutrition committee had proposed that the draft guidelines be advanced to step five of the eight-step Codex procedure. Earlier in this document you have what those eight steps are.

When the proposal from the nutrition committee went to the Codex Alimentarius Commission last June we strongly objected to the elaboration of these guidelines and expressed concern about their potential interference with fair trading practices and safe products that may benefit the health of Canadians. We recommended, as you can see at the bottom of that particular page, that the commission stop work on these particular guidelines.

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Turning to the next page, entitled “Commission Decision”, the 22nd session of the commission returned the guidelines to step three. In other words, the nutrition committee had proposed that they proceed to step five of the eight-step process. The commission returned them to step three because of the concerns raised by Canada and a number of other countries.

The commission also requested that there be a fundamental re-examination of the need for those guidelines, and that will be carried out at the next meeting of the nutrition committee in September 1998.

So whereas our view is that Codex should not be developing these guidelines, at least for the moment we've managed to push them back with the help of a number of other countries to an earlier portion of the Codex developmental process for further review.

The next one is perhaps the easiest one to deal with. That's potentially harmful herbs and botanical preparations sold as foods. The nutrition committee has been considering the development of a list of herbs and botanical preparations that should not be sold as foods because of safety concerns. There is a linkage in this particular issue back to schedule 705. It was actually Canada that had proposed that Codex address this issue, primarily because of the controversy in Canada about schedule 705.

Our thinking at the time—and this was back in 1994—was that if we managed to get all the countries in the world who have an interest in this particular subject to combine their knowledge and expertise, we might perhaps get some international agreement on what herbs and botanical preparations should be sold as foods and which ones should not. This was put on the Codex program back in 1994 at Canada's initial suggestion.

When the CCNFSDU, with a nutrition committee, looked at that—and they've looked at it a couple of times—at the most recent meeting just about a year ago, the committee decided this was really an issue that should be addressed by national authorities and that they did not have the expertise within Codex to deal with this issue. Their recommendation was that no further work be done by Codex within this particular field.

If you look at the next page called “Discussion at the 22nd Codex Alimentarius Commission”, the position we took at that particular session was that we supported the recommendation of the nutrition committee that Codex not develop a list of potentially harmful herbs and botanical preparations.

Our feeling on that particular subject, as you can tell, has evolved over the last three years. We tend to see it now as an issue that you have to look at from a legal point of view, how these particular products are classified as foods or drugs. You have to look at the basis on which these are assessed from a science point of view or from another basis point of view, and our thinking at the moment is that Codex should not address this particular subject. Indeed that was the decision of the commission last June, and it deleted this particular issue from the commission's work program.

So the concern that has been raised within Canada that Codex would develop a list of herbs and botanical preparations that should not be sold as foods is no longer an issue. Codex is not going to be addressing the issue at all.

I hope that helps to clarify what Codex is and the two issues that have been of controversy within Canada, both with regard to vitamin and mineral supplements and herbs and botanical preparations. Thank you.

The Chair: Mr. Michols.

Mr. Dann Michols: With that presentation, with the binder and the presentation last week, I think we've done our best to give you all the information we have on this subject, and we'd be delighted to answer questions.

The Chair: Thank you very much. We have some extra material that he gave us with the new index, which we will hand out afterwards. Some of you already have it.

Dr. Hill.

Mr. Grant Hill (Macleod, Ref.): Thanks, indeed. My habit is to try to ask a short question, and if I could get a short answer so that we don't have speeches, that would be super.

For Dann, first off, in the last presentation you suggested that there really wasn't much of a problem, that everything was moving along and all these panels were going to end up with a good result. But the one thing that constantly sticks in my craw is the safety issue, where you say that's paramount and you ban products in Canada like melatonin—and I'm going to refer specifically to melatonin—and yet allow their importation from the U.S. That's totally inconsistent, and I have yet to have somebody explain to me how that could be sensible. This is your opportunity to tell me why melatonin is not for sale in Canada but can be brought in from the States.

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Mr. Dann Michols: Okay, and hopefully I will do it in as short a time as possible.

I didn't mean to indicate in my presentation last week that there isn't a problem. There is a problem. The reason the standing committee is looking at the mandate, the reason there's an advisory panel, and the reason there's regulatory activity with us is an acknowledgement that the regulatory framework that pertains to these products is not appropriate at this time, given the demand, given the knowledge, and so on. So we're involved in that exercise. We are very much interested in the safety as well as the quality and the effectiveness of these various products.

On the therapeutic products side, we do not ban substances. We are a reactive organization that requires that a sponsor who wishes to have a particular substance or product marketed in Canada as a drug, under the definition of the Food and Drugs Act, present to us a data package, a package of information, sufficient to prove the safety, quality, and effectiveness of a particular product according to a range of guidelines that we have made available.

So the reason that any product, melatonin included, is not available on the Canadian market is not that we have banned it; it is that we have not approved it because we have not received a package from a sponsor following the guidelines we have set. The reason it is available to be imported is it can only be imported into Canada if it is for personal use. It cannot be imported into Canada for sale, because we have not approved the sale within Canada.

Mr. Grant Hill: Okay. I'll turn to Mr. Lambert.

You're the enforcement guy, the guy who tries to make certain that products are not approved; I won't use the word “banned” now. Can you comment on the use of what I call SWAT teams with battering rams and some very heavy-handed approaches to individuals who are being accused of having some of these products, such as melatonin 1, DHEA, and others? Why would you need to go to those lengths?

Mr. Jean Lambert (Director, Compliance and Enforcement, Department of Health): I'm sorry; you have not given me specific enough information for me to answer your question. I don't believe there are SWAT teams. There are no such things.

We are, as much as we can, handling the issue on a national basis in collaboration with the industry. If there are instances where some importers or dealers in Canada have felt they were treated differently, I'm not saying the feeling may not be there, but we are doing the very best we can to get uniformity of enforcement.

Very specifically on the issue you've raised, personal importation, we're working on an enforcement directive to ensure uniformity of application, to make sure that whether you are in Halifax, Toronto, or Vancouver, if you are in non-compliance, you'll be treated the same way.

Mr. Grant Hill: Do the RCMP handle some of your enforcement duties when it comes to search and seizure?

Mr. Jean Lambert: Can you repeat the question? I'm sorry.

[Translation]

Mr. Grant Hill: Is the RCMP involved in some of your enforcement duties regarding people, searching for products and so on? Is the RCMP involved?

[English]

Mr. Jean Lambert: The only instances where a police force would be used would be where enforcement action were absolutely required. It would be an exceptional case where the RCMP would be involved. In 99.9% of all the situations we have to handle—and it's probably a lot higher than that—we don't use police corps to assist us in doing our enforcement activities. That doesn't mean it cannot be done if it's worked in collaboration, but if it's strictly related to the enforcement of the food and drug regulations, we don't need the RCMP to do our work.

The Chair: Thank you.

Madame Picard.

[Translation]

Ms. Pauline Picard (Drummond, BQ): Good morning.

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I must say that I feel a bit overwhelmed by all this information. I am neither a scientist nor a physician. Faced with this enormous amount of material, I have some difficulty forming an opinion.

I am going to ask you a very mundane question. At some point, it was said that there was no requirement for pre-market approval. I understand that when someone, a sponsor, for instance, develops a product based on some kind of herb and, according to today's ways, markets it as a tea with calming effect, he is not required to have this product approved by Canadian laboratories before putting it up for sale on the shelves of various drugstores or at Jean Coutu's.

The way I understand it, only manufacturers who want to have their product labelled and sell it nationally are going to ask for your approval. They only have to submit a form to show that their product is safe and then, it can be approved.

I am also wondering about some products imported in Canada, from India or China, and which you find on store shelves with labels written in the language of the country where they were developed. In that case, you don't know what it's all about. However, the store attendant, whether he is a pharmacist or not, can usually tell if, for instance, it's a laxative. People who trust Chinese products are going to buy it.

I am very confused about the approval process. What can be distributed? Do you have a list of products which are considered as food and of those which are considered as drugs? Are there any products on the market which are not included on either list because you never heard of them? Do I have a correct sense of the situation or not?

[English]

Mr. Dann Michols: Let me give a very simple response, and then I'll ask Mary to get into a little bit more detail.

Any product that seeks to be marketed in Canada as a drug, which means that it falls under the definition in the Food and Drugs Act as a drug, requires pre-market approval. What is required to obtain that pre-market approval varies according to the risk of the particular product, but they all require some sort of pre-market approval.

I will ask Mary quickly to give you an indication of some of the requirements that are involved in those.

Ms. Mary Carman (Director, Bureau of Pharmaceutical Assessment, Department of Health): To go back to your first question, une tisane avec des propriétés calmantes, a tea that has a calming action, where that is on the label of the product—it's sold as a package and it says “This will help you get to sleep”—would be considered to have a therapeutic claim and there is a pre-market requirement.

Let's talk about tisane herbs that are in there and the pre-market requirement. If those herbs have been well documented—they're generally called European herbal medicine—over the years as having a calming effect and over the years—we're talking generally about centuries, not several years—as not harming people while having that calming effect, those references would be acceptable. The manufacturer or the sponsor would need to show us those references.

The manufacturer would also need to have in place, under the other aspect, conditions and tests where they would be able to identify and track that indeed the herbs they were putting in their product were the ones that they intended to put there and they knew what was there and in what quantity. That's the pre-market process for a traditional herbal medicine from the European-based herbal medicine. So your tisane, if it's just camomile tea and it's really nice with honey with it and it makes no claim, is a straight food product.

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The exact same ingredient as a calming sleep tea would be a drug and would be subject to both pre-market and would have a DIN, a drug identification number, eight digits on its main panel, the one the consumer sees on the shelf, and you would know, or should know, the difference. Our inspectors and other compliance people, the industry, competitors, would be able to verify whether or not that product had been issued and gone through the appropriate pre-market process.

Your second question was about whether or not we specifically test products before they come to the market. Our laboratories are used for generally enforcement compliance or verification testing, so if there's a problem or if we are searching out something.... But we do not create the data for someone to put their product on the market; that's theirs.

The Chair: Okay.

Mr. McTeague.

Mr. Dan McTeague (Pickering—Ajax—Uxbridge, Lib.): Thank you. I won't take the liberty of being on this side of the room in order to ask a question that is consistent with some of the other members here.

I'm interested in the process for your assessment for pre-market approval. I believe I may be able to take off where you just left off. How does the demise, or the removal, of several members of the drugs directorate impact on your overall ability to make a proper assessment?

Mr. Dann Michols: You're referring to the devolution of the bureau of drug research announcement?

Mr. Dan McTeague: Right.

Mr. Dann Michols: It's my considered opinion that it doesn't in any way impede the activities of my organization to ensure that therapeutic products are safe, of quality, and effective. What we did was as much an organizational move as anything. We took the 68 scientists and technicians that were in the bureau of drug research and we redistributed them amongst various other bureaus that are still existent within the therapeutic products program. So those that were involved in biologics, vaccines, blood, and blood products research have moved to the bureau of biologics. Those that were involved in pharmaceutical activities have either moved to the review bureaus or have moved to an office of science activity that we have set up.

Only as it pertains to research connected to pharmaceuticals, which is a particular subcategory of drugs, have we moved to a position of purchasing the requirements in terms of research from external sources such as universities or commercial laboratories. We still have the capacity within the therapeutic products directorate to test the drugs under investigation, as Mary has mentioned, in laboratories across the country that are under the responsibility of Jean Lambert, and we still have the capacity in-house to deal with biologics research. We intend to purchase pharmaceutical laboratory research from other areas.

Mr. Dan McTeague: When you say “purchase”...can you elaborate a little bit?

Mr. Dann Michols: When and if we require research to support our regulatory activities, we would contract universities or commercial laboratories to obtain the work we needed to be done.

Mr. Dan McTeague: Would you explain to this committee the difference then? I understand that in terms of definition there may be a problem, up until say several weeks ago, between the drugs directorate and the therapeutic department, which you administer.

Mr. Dann Michols: Yes, hopefully, quite easily. Under the Food and Drugs Act, Health Canada has the responsibility for regulating drugs as defined in the act and for regulating medical devices as defined in the act, as well as other substances such as food. As of January 1, the responsibility for regulating drugs and medical devices was combined into one organization that I am responsible for.

Because it was drugs and medical devices, and for other softer reasons that have to do with the connotation around the word “drug”, we decided it was an opportune time to rename the organization to “therapeutic products”. It has still the same capacity as existed within the drugs directorate and within the medical devices program; it has just been brought together under a new rubric, “therapeutic products”.

• 1200

The Chair: Ms. Wasylycia-Leis.

Ms. Judy Wasylycia-Leis (Winnipeg North Centre, NDP): Just before I begin my questioning, I might suggest that since time is so short in terms of being able to get into an in-depth dialogue with departmental officials, we might consider bringing back some members of the department at our first meeting in February.

The Chair: We'll discuss that. Maybe after a couple of meetings we'll have them. It's a good idea.

Ms. Judy Wasylycia-Leis: Just to follow up Dann's question for starters, maybe I'll ask several questions at once and then he can answer them all if possible.

The Chair: Don't forget that you have only five minutes for the questions and answers.

Ms. Judy Wasylycia-Leis: I was surprised to hear Dann Michols' comments with respect to the biologics bureau, given what Judge Krever said in his report, just released, around the need for a clear regulatory capacity within the health protection branch and the presence of strong in-house capacity and the avoidance of third-party involvement in order to ensure that, in this case, Canada's blood supply is absolutely safe and protected. That's the first issue, and the question would be, is the suggestion that Mr. Michols just made today being reconsidered in the light of Justice Krever's report?

The second question is that I'm having some difficulty trying to address this whole issue in the absence of a sense of a broad regulatory framework in the health protection branch. The question that many of us are getting from people across this country is, why is government involved and why has it been involved for so long in trying to regulate and become more pervasive in the field of herbs and botanicals and vitamins and minerals when we've seen in other areas government to be pulling back from a strong regulatory approach? Why are we regulating what would appear to be low-risk products when we seem to be deregulating or moving out of the field of tough regulation in terms of high-risk drugs?

What comes to mind, of course, is the whole blood inquiry and the fact that it took a public inquiry, it took a massive outcry from the community to say something's wrong and to point to problems in terms of regulation when it's something as important as Canada's blood supply.

We've also just had to deal with the closure of the drug research bureau, which everyone has understood to be an important body in assessing and researching the impact or the interaction of drugs and other drugs and foods and so on. I think there's a real loss of confidence on the part of people in this country about whether, in those areas where we now believe we have strong regulatory controls, those regulations aren't in effect.

So the question is, why are we dealing with this now, when we've got so much uncertainty around a regulatory approach in the health protection branch?

I've got other questions on that.

The Chair: You've got one minute left for the answers.

Mr. Dann Michols: I have one minute left to answer it?

Very quickly, if I didn't make my point clear in the answer to Mr. McTeague, let me say it again. In the move to close the bureau of drug research we did it exactly to strengthen the bureau of biologics. We moved 25 scientists into the bureau of biologics, because we believed that is a priority area. So we did not in any way weaken and in fact anticipated many of Justice Krever's comments and have strengthened our regulation of biologics, including blood.

Secondly, I can't speak to the absence of a regulatory framework within the health protection branch, but I can certainly speak to the presence of a regulatory framework within the therapeutic products program. Under the Food and Drugs Act these products are drugs and have always been drugs.

We are not in the process of deregulating high-risk products. We are in the process of determining the appropriate regulatory framework for all products in Canada that might be labelled as drugs.

The closing of the bureau of drug research, as I mentioned before, does not impact our capacity to regulate these products.

• 1205

Their increased use in Canada—and I'm now talking about natural health products—has led us to review the regulatory framework in place. It has led us to review the resource allocation to this particular area. As well, we are attempting, with the help of the committee, we hope, with its report in this area, to ensure that the appropriate regulatory framework and the appropriate level of resourcing is available to ensure that Canadians only have access to products that are safe and of high quality and that do exactly what they feel they should be doing when they purchased them.

The Chair: Thank you.

Mr. Volpe.

Mr. Joseph Volpe (Eglinton—Lawrence, Lib.): Dann, first of all, thanks a lot to you and your team. I think the briefing you've provided us, both orally and in writing, is excellent.

That said, there have been a couple of questions raised that recall, at least for me, some of the activity that members of Parliament were unhappily involved in—“unhappily” because we didn't like being bothered by a lot of insistent lobbying activity last spring.

One of them deals specifically with Codex; all of this is related. You quite rightly acknowledged, and I was pleased to hear it, that both public practice and public consumption of products is moving at a rate much quicker than the system is able to absorb and deal with.

One of the concerns of the public, at least from the perspective of lobbying conducted last spring, was that Codex was in the hands of multinational pharmaceutical organizations and because of that was going to present a list of products, mainly herbals, that would no longer be able to be sold freely over the counter here in Canada.

You've given us an explanation that's obviously completely different. It's put everything in perspective. But we're dealing with the public perception now, and I'd like you to address that.

Second, the concern is that Health Canada would not have the regulatory or statutory authority to be able to prevent some of these decisions being imposed on Canada.

Third, and probably most important, the concern is that there is a perverse political will at play that prevented us, as Canadians, from exercising free choice in using products that have age-old, centuries-old, histories of efficacy behind them, and that Health Canada is completely out of touch with this new reality.

One, they didn't know the demographics of the country and the consumption of those new demographics.

Two, they were unwilling, or perhaps afraid, to recognize that the consumption of herbal medicines now equalled about 40% of the consumption of the pharmaceutical varieties that, I know, Dann, you have been closely tied to over the course of the last six months.

Can I get some reaction to that?

Mr. Dann Michols: As I think Mr. Burke explained, and as we attempted to write in the briefing material, the Codex Alimentarius is a food-oriented operation that has to do with developing international standards. I don't think there is anything within Codex that infringes in any way on the ability of the Canadian government and the Canadian regulatory operations to do their own job vis-à-vis products that would be available as foods or drugs within Canada.

Because in Canada vitamins and mineral supplements are considered to be drugs, the Codex would not even be considered in that particular regard. As they move to take a look at the standards for foods—toxicity and so on—we would still have the capacity to determine how that activity was applied in Canada. So vis-à-vis the Codex, I think the material is available.

• 1210

In terms of the comments about Health Canada perhaps being out of touch vis-à-vis the regulation of some of these natural health products as drugs, I don't think that's the case either. We have guidelines in place and we use those guidelines in the approval of a range of products that we call traditional medicines that have been used, as Mary says, for decades or centuries for a particular traditional application. We have approved many products. They are on the market and available.

Part of the challenge that faces us, and I think the reason for the minister wanting this issue of an appropriate regulatory framework to be considered by the standing committee, is that many of these products are beginning to move outside of their “traditional uses”. Traditional Chinese remedies are no longer being prescribed only by traditional Chinese practitioners, ayurvedic practitioners, native North American practitioners, or whatever. They are starting to move outside of those particular conditions and the particular knowledge base that used to apply around them.

We need to determine how best to regulate those products within that broader context. We undertook a number of initiatives, such as the advisory panel that was set up with representatives from across the board to advise on that area. One of them is the activity of the standing committee.

The challenge before all of us is to determine the appropriate regulatory framework for these products so Canadians can exercise a free but informed choice in using these medicines. They should have the information available to them on what these medicines can do, and a regulator should back up the safety, quality, and efficacy aspects of those medicines.

The Chair: Thank you.

Mr. Vellacott.

Mr. Maurice Vellacott (Wanuskewin, Ref.): At the bottom of page 6 you make the point that schedule 705 has no regulatory status. In a word or two, what status does it have if it doesn't have regulatory status?

Dr. Harry Conacher: At the moment, schedule 705 has been held in abeyance pending all of the consultations that are going on right now. Back in the 1980s, when we first established the expert advisory committees, our thinking was to have this as a list of prohibited herbs and botanicals in the regulations. So there was going to be a negative list in the regulations for foods.

Mr. Maurice Vellacott: Does this have enforcement status?

Dr. Harry Conacher: No, not at the moment. Most of the enforcement aspects in relation to foods at the moment are conducted by the Canadian Food Inspection Agency. This is one big change that has occurred over the last two or three years. We are now having discussions with the agency relating to consultations as to how to best regulate these products.

Mr. Maurice Vellacott: Is melatonin on schedule 705?

Dr. Harry Conacher: I couldn't tell you.

Mr. Maurice Vellacott: The point has already been made that in countries like Germany, vitamins, minerals, and capsules are regarded differently, whereas in Canada we currently regard them as drugs. We have a different standard certainly from countries such as Germany. Is it a higher standard or a lower standard when we regard them as drugs?

Dr. Harry Conacher: When it's a question about drugs, I'll defer to my colleague.

Mr. Dann Michols: How the various products are regulated in various countries depends upon the enabling registration for that regulatory process. In Canada, because of the definition of drug within the Food and Drugs Act, vitamin and mineral supplements would be considered drugs.

I'm not sure whether that leads to a higher or a lower standard against which these products are measured, depending upon the regulatory framework within the country. It means a different approach, if you like, to these particular products.

• 1215

Mr. Maurice Vellacott: My impression is it would probably be a little more rigorous with drugs.

Mr. Dann Michols: I would suspect that if a product is looked upon as a drug that therefore has to prove a therapeutic value it would be a more rigorous standard.

Mr. Maurice Vellacott: So we're not subjecting or exposing ourself to trade restrictions by having them in the drug category.

Mr. Dann Michols: No.

The Chair: Dr. Bennett.

Mrs. Carolyn Bennett (St. Paul's, Lib.): How did we get in this pickle if the system actually is working? I feel for those of us who were out knocking on doors in the election...and also as a physician, when every day in my office people were upset about this.... How did it happen that garlic pills end up being a criminal offence? How did we get to schedule 705, and what are we going to put in place such that this doesn't happen again?

With Dr. Hill, I feel we were trained first to do no harm. I would say as Health Canada you would then want to ban things that do harm. But it looks as if the approval process is around efficacy. I think those of us who work with people with cancer and work with people...there may not actually be research that shows people's diseases are getting better, but there's good research to show they feel better. I think people such as Bob Buckman are saying it's not up to us to take away things that help people feel better, even though their disease is getting worse. It's very difficult to do that, but I guess I'm seeing approval versus banning, and first do no harm versus efficacy. That is going to be a difficult job for this committee. I would love some help with that.

The second is, are people actually getting what it says on the label? In my experience there are obviously some episodes with some of the athletes who think they are taking Echinacea and are actually getting Dristan. So we obviously need some.... No wonder the Echinacea makes their cold feel better. It has ephedrine or pseudo-ephedrine in it.

What are we going to do to put that in place? I can't see that we can do that without testing labs and various ways we can protect the public.

The third thing is what on earth are hemp and all of that doing in your department anyway? It's clearly an agricultural thing. I have patients and clients who are doing research in hemp and can't even get their hemp cakes across the border to do their research. How do you guys get that out of your department and put it into Agriculture, where it belongs?

Mr. Dann Michols: Perhaps there are three questions there.

How we got into this pickle in the first place, as you say, is the subject of a long conversation, with more time than I have available at the moment. But part of that I think has to do with a general lack of understanding on the part of many people of exactly what the regulatory regime is in Canada vis-à-vis drugs and exactly what status particular products that might be called “natural health products” have vis-à-vis that drug standard. It has always been our position that we are not in business to limit the access of Canadians to products that are safe, of high quality, and effective. How you put into place a regime that ensures safety, quality, and effectiveness is what we're debating, and we are looking forward to your help on that matter.

In our discussions with the advisory panel that is in place and that we hope you will allow to present their findings to you when you next meet on this subject, there is general agreement that there have to be safety standards, there have to be quality standards, and there have to be effectiveness standards. How you go about setting particularly those effective standards I think is the debate. If they are traditional or non-traditional...or how you handle a new product such as melatonin when it comes on the market if you aren't presented with a package proving its safety. That's exactly the question we're attempting to wrestle with and to set into place a regulatory framework for.

• 1220

It is our belief that when someone does take a product, it ought to be exactly what it says it is, and that ought to be on the label. It shouldn't be any more or any less than the dosage and it should be the product, as you mentioned.

The next issue is hemp. We are not particularly interested in regulating hemp as a medicine. The reason we are involved in hemp regulations is that we are also responsible for the enforcement of the Controlled Drugs and Substances Act. That has to do with cannabis, and hemp bears many similarities to cannabis.

What we are trying to put into place—and we are trying rapidly to do this right now—is regulations that will enable the commercialization of hemp but will also meet many of the concerns of Canadians and particularly of law enforcement agencies that it does not become an easy way to introduce marijuana into society. So we aren't attempting to keep out hemp; we are attempting to put into place a regulatory framework such that hemp can be commercialized and become a commercial entity within Canada. We are doing it because we have responsibility for the Controlled Drugs and Substances Act.

Ms. Carolyn Bennett: Does hemp have any THC in it, really? I just don't see that.... By using that argument, we're actually propagating the rumour that it has anything to do with marijuana other than that they look alike. Maybe it makes it difficult for people to sort out if this is a case of hemp or a case of marijuana. Once you sort out which it is, it seems clear which is agriculture and which is health.

Mr. Dann Michols: You're absolutely right. The challenge before us is to put into place the mechanisms where you figure that out in the first place. Once it is figured out such that it is proven that it is hemp and it has a very low or no THC value in it, it can go and do its own thing. How you go about putting into place those filters and mechanisms such that all stakeholders are sure their particular interests are met is exactly the dilemma we have at the moment because the products look so much alike.

The Chair: Can I interrupt here? We have at least six more people who would like to ask questions. I don't know about the rest of you, but I'd like to hear the answers and the questions. Can I suggest that anybody who really must leave go now? If the kind people would stay for another half hour or so until we get our questions answered...is that okay with everybody?

We'll just carry on. If you have to leave, just leave.

Would you mind staying for a while longer?

Mr. Dann Michols: No, we don't mind staying at all. I would also suggest that if there are further questions that come up, we would be delighted if you would pass them through yourself or the clerk. We'd be delighted to prepare another briefing note if it's not already available.

The Chair: We will definitely have you back later on, because by the time the middle of February comes we'll all be up in the air.

Mr. Dann Michols: Okay.

The Chair: Mr. Dumas.

[Translation]

Mr. Maurice Dumas (Argenteuil—Papineau, BQ): You participated in discussions at the 22nd session of the commission in Geneva. Who were the members of that commission? Who was attending? Were there any parliamentarians present? This is my first question.

The second one is of course about schedule 705. You mentioned objections raised by the public. For what reasons? Is it because this measure was considered too harsh or too lenient?

I will ask my third question later. It has to do with recent events. Dr. Bennett has already raised the subject briefly.

[English]

Mr. Ron Burke: At the 22nd session of the Codex Alimentarius Commission the governments are represented by senior officials within the government. It's usually officials from the departments of health or the departments of agriculture, those that have particular responsibilities for the issues Codex deals with. In the case of Canada the head of the delegation was Dr. George Paterson, the director general of the food directorate and my immediate boss, who is also a representative of the Canadian Food Inspection Agency as his part on the delegation.

[Translation]

Mr. Maurice Dumas: No parliamentarian was in attendance.

[English]

Mr. Ron Burke: No, there were no parliamentarians present.

Dr. Harry Conacher: In connection with the objections raised to schedule 705, it was primarily freedom of choice issues. The public were concerned that they would not have available to them substances that they felt they needed. That was the primary objection to schedule 705.

• 1225

It's interesting that in the first publication of schedule 705 those objections weren't there. It was only when it was published the second time that those objections arose, and they have continued ever since the publication of that schedule back in 1993. It's freedom-of-choice issues. The public felt they would be denied access if this were promulgated to those substances.

[Translation]

Mr. Maurice Dumas: My third question concerns a subject which is often raised in the press in articles regarding the fight against AIDS. Is marijuana going to be decriminalized some day? Is there any process that has to be followed to achieve this? Are there any initiatives that should be taken in this regard? Health Canada is probably going to do some research on the subject and then, parliamentarians will have to discuss it to give their approval.

[English]

Mr. Dann Michols: As for the issue of the possible use of marijuana as a medicine, at the moment there are no barriers to researchers coming forward to us with a data package that indicates that any product, including marijuana, has medicinal value and that they would like to make it available for therapeutic purposes.

We are waiting for a data package to deal with that product. It's not our role as regulators to undertake that research. We don't have the resources to undertake that research, but we will be delighted to review a data package when it comes forward.

That is separate from the issue of the decriminalization of marijuana. We're talking from our perspective in terms of marijuana, melatonin, or any other product as a therapeutic. We are fully prepared to review it. If the data package is there to support safety, quality, and efficacy, then it would be approved.

The Chair: Mr. Michols, why do you think nobody has come forward?

Mr. Dann Michols: That would be speculation. First of all, the research projects have to be undertaken. The body of knowledge has to be developed and then presented.

The Chair: Why do you think nobody has done this? I'm just asking the same question that everyone else is asking.

Mr. Joseph Volpe: Madam Chair, just as a point of order, I think we're asking our witnesses something that falls in the realm of politics. This is a role more specifically determined by the members on this side and that side of the table rather than their side. I'm wondering whether we could just absolve him from answering the question that doesn't pertain to his area of jurisdiction.

The Chair: I just wondered whether he had any comments.

Mr. Joseph Volpe: If he does answer it, I'll be very upset, because he's answering as a parliamentarian.

The Chair: I just wondered what his comments were on it. Would you rather he not answer any more?

Mr. Joseph Volpe: I rather hope he wouldn't.

[Translation]

Mr. Maurice Dumas: Madame Chair, I just want to say that this is a personal comment by Mr. Volpe. It's his opinion. Maybe it's not the opposition's opinion.

[English]

Mr. Joseph Volpe: If you want to have the same opinion, I'd be delighted to have that question raised in the House of Commons as a position by one of the parties on either side of the House such that you are in fact in favour of proceeding according to the direction of your question. Also, give us the appropriate reasons.

The Chair: Okay, I opened up a can of worms. Sorry. I just wondered whether he had a comment to make.

Mr. Joseph Volpe: He probably doesn't.

The Chair: Let's go on to the next person.

Mrs. Ur.

Mrs. Rose-Marie Ur: The question was asked by Dr. Bennett earlier, and I don't think it was really answered, so maybe I'll ask it again.

Was the department red-flagged by an increased use of herbal products or by an increase of incidents regarding people who were taking herbal products? What all of a sudden got this going? Or was it Codex that got the ball rolling?

Mr. Dann Michols: I'm not sure it was either. We have always been responsible for the regulation of these products, and we have been dealing with the submissions for pre-market approval or subsequent compliance activities.

I think the events of last spring were perhaps spurred by a number of activities. One of them certainly had to do with our regulatory activities in attempting to rationalize the need for establishment licences and bring into effect an establishment licensing regime. We did that for a number of reasons. Ironically, one of those was a recommendation by Chief Justice Krever that we move a number of products that did not require licensing into a licensing regime and so on.

• 1230

So we developed the establishment licensing regime for a number of regulatory reasons, but what that did was require the proactive activity of a sponsor who wanted to manufacture products to apply for a licence, as opposed to the reactive responsibility that existed in the past of meeting GMPs and being available for us to inspect.

Secondly, because of the general policy that exists across the government for cost recovery, we obviously proceeded to consult on a regime of cost recovery for those establishment licences. That had some impact as well.

Thirdly, the increased use, and as Mr. Volpe mentioned, the communications that developed connected to that and the information that did or didn't exist, have had an added impact as well. But we have always been responsible for regulating those products.

Mrs. Rose-Marie Ur: Do you have in the department a group of experts on this particular issue who are really on top of herbal products in this particular facet, just this little group of herbal remedies? Do you have people who have a really direct knowledge of herbal products, or do you go outside the department to bring all this knowledge in?

Mr. Dann Michols: We do both. We have 750 people within the therapeutic products program dealing with these products, most of whom are scientists and medical officers who have knowledge in toxicology, chemistry, biology, medical sciences, and so on. Also, when we need to augment that expertise, we do go outside.

Mrs. Rose-Marie Ur: On my next question, I don't want to seem light about it, but as you said, some can be considered food and others drugs, depending on the packaging and the claims they make. Does this not lead to some kind of confusion?

Health Canada's mandate is to maintain and improve the health of Canadians. Yet we have, say, cayenne pepper. I don't think too many people have died from cayenne pepper. We have asthmatic therapies where it's been noted 257 people have died from asthmatic products. We have garlic cloves, and thank god not too many people have died from garlic cloves, but we have 370 deaths from cardiovascular drugs. I don't want to be dropping off my dinner guests by feeding them garlic and cayenne pepper. I don't see the reasoning in this.

Mr. Dann Michols: I'm not sure what the—

Mrs. Rose-Marie Ur: You're stating that garlic cloves could be unsafe—

Mr. Dann Michols: No.

Mrs. Rose-Marie Ur: Or perhaps cayenne pepper could be unsafe. If it gets put into a tablet and says it can do x thing for you, then it is a drug.

Mr. Dann Michols: That's right.

Mrs. Rose-Marie Ur: But if you drop it in as a seasoning, you're going to survive. Am I right or wrong?

Mr. Dann Michols: It would depend on the product you were dropping in as a seasoning as to whether you were going to survive.

Mrs. Rose-Marie Ur: I'm talking about cayenne pepper right now. It's not arsenic.

Mr. Dann Michols: We'll take garlic as an example. Garlic is a food when it is consumed as a food. You use a clove or two of it in your food preparation. You are using it as a food. You expect it to be a food. You're using it for seasoning.

When you move into the realm of claiming a therapeutic benefit to that particular product, and when you move into the manufacturing process, where you would be producing a capsule or a pill or a powder or a tincture or whatever, you are introducing other factors into the process. You are then putting a label on it.

If you want to buy that product, I would think you would want to know a couple of things. You would want to know that what is in that product is actually in there. You would want to know that the dosage that is represented on the label is actually there. And I would think you would want to know that whatever the claim is, there is some justification to that claim.

You have moved out of the realm of using garlic as a food into the realm of using it as a medicine, and that brings into place a range of unknowns that I think you would want to be aware of before you proceeded any further.

The Chair: Thank you very much. Your time is up.

Ms. Wasylycia-Leis.

• 1235

Ms. Judy Wasylycia-Leis: I'd just like to follow up on Carolyn Bennett's question about how we got into this pickle in the first place. It seems to me that just saying there's greater use among Canadian consumers is not sufficient. There had to have been actual evidence of risk to Canadian consumers because of that greater usage. So that's one question: was there some identified risk as a result of that greater usage?

Secondly, was there in fact a huge outcry from the big multinational drug companies because all of these products were eating into their markets?

On that specific question, I understand the branch had banned yam cream from the market. Was that a result of safety factors or was it a result of complaints from the industry?

The second part of the question is with respect to the whole issue of cost recovery and the process for regulation. If it's simply a process of assigning DINs based on supposed safety issues and getting the feedback in order to pay for other things in the department, how is that protection for the Canadian consumer when in fact it is not much more than a paper process? It doesn't ensure, as Carolyn mentioned, that the consumer knows that what's in the bottle is what's on the label.

She mentioned the issue of cold medicines for athletes. There was also an issue around ginseng recently in terms of a patient getting into some trouble because what was in the bottle was not on the label.

If a cost-recovery process is driving all of this, then how is it any great safety for Canadians?

The third point is with respect to Mr. Michols' comments on the drug research bureau. I understand what he is saying in terms of resources going to biologics research. That doesn't answer the question about what capacity we have left in terms of an independent research bureau to do precisely what Carolyn Bennett mentioned, which is once you've gone through the process of assigning DINs, what have you got in government to ensure that we've tested the products consumers feel are safe and it's not left to a buyer beware, industry-driven process?

Mr. Dann Michols: In answer to your first comment, about whether or not we were reacting to these products because of safety or other concerns to the public or complaints by the pharmaceutical industry, I can say definitively at this point that we have never regulated in this area as a result of complaints of an established pharmaceutical area.

We are concerned about the safety, quality, and efficacy of these products in and of themselves, and safety has as much to do with a claim being made that cannot be delivered as it has to do with the toxicity of the particular product.

As I attempted to explain last week, in terms of the cost-recovery program, we are in the business of cost recovery for our activities because it is a government policy to do so. The appropriations for this purpose have been removed from our program and we cost-recover our activities. The money comes back to our program to enable us to undertake the activities, and those activities might be submission review, inspection, investigation, or whatever.

Where the actual revenue goes from that range of fees was set out within the presentation, but it has to do with more than just signing a piece of paper. It has to do with having the capacity to review the claims that are being made and then being able to investigate, following up, should there be a problem.

All of the money collected goes towards the activities of the program, and it doesn't cover 100% of those activities.

Thirdly, again in terms of the issue of devolving the bureau of drug research, we have exactly the same capacity within the therapeutic products program for research and laboratory support to the biologics area and to the testing capacity across the country as we had before we made the organizational change of eliminating the bureau of drug research.

What we did with that particular change was save some money, partly in terms of senior management within that bureau, partly in terms of not having to support, on the pharmaceutical research tithe, an in-house capacity, because that can be a very expensive proposition. So we think we have a more effective, efficient use of the resources by the changes we've made.

• 1240

As far as biological drugs are concerned, and as far as being able to test the products on the market goes, we have the same capacity we have always had, and hopefully we'll be able to augment it as we become more efficient in a number of areas.

Mr. Joseph Volpe: Madam Chair, on a point of order, for clarification purposes, that answer Mr. Michols just gave in response to the question is about the third time during the course of this session...could Mr. Michols clarify for us whether the department has ever done any proactive research, any research independent of applications? Could he tell us whether the department would be in a position to do that after this reorganization?

Mr. Dann Michols: Yes, we have done proactive research from time to time. If we have a concern with the information in a particular submission—and maybe I'll ask Mary to go into a little more detail—we certainly have the capacity to be able to undertake some research ourselves. If we are concerned about the interactions of various drugs, the manufacturer might say they have the information we need on a particular product, but we might be interested in the effect of that product when taken with other products and so on.

We had the capacity prior to the organizational change. We still have that capacity. We still have the capacity in-house in a number of areas and we are fully capable of contracting the research to a university or to another facility should we want questions answered.

The Chair: Ms. Carroll.

Ms. Aileen Carroll (Barrie—Simcoe—Bradford, Lib.): So you can outsource in that regard.

Mr. Dann Michols: Yes, we can. There are facilities across the country that are perfectly capable of helping us with that.

Ms. Aileen Carroll: Good. First of all, Mr. Michols—

The Chair: Did you want to respond to that, Ms. Carman?

Ms. Mary Carman: Research has been developed, generally not unique to a product, where we had a particular concern about a group of products and would want to develop a methodology or test that could be a predictor. We would then not carry that test forward. We would work on it and then use it as a regulatory instrument. We would require the regulated industry to use that test in their drug development in order to give us the information. We would not go through and test. In general, we would not look specifically at a product unless it was a direct problem we had already identified and we needed to investigate it to find a specific answer for compliance and for consumer safety.

The Chair: Thank you.

Ms. Aileen Carroll: At the outset, thank you, Mr. Michols and Ms. Carman, for the additional information that you provided this morning, which I know was in response to my question.

If I can draw your attention to that first of all, Mr. Michols, you gave us information on the other expert advisory committees that have met and dealt with some of the aspects this committee is now considering.

As a new member of Parliament, I hesitate to ask for a report for fear it will be a truck that delivers it to my door, and we have a small office. I wonder if executive summaries of the 1993 report are available.

Mr. Dann Michols: I'm sure they are.

Ms. Aileen Carroll: I would appreciate receiving that, again, if it's a relatively readable document.

The Chair: Were your documents provided for the whole committee?

Mr. Dann Michols: Yes, certainly.

Ms. Aileen Carroll: If I can draw you attention to what is now under section 42, which Mr. Michols gave me in response to my query, you mentioned that two expert committees have met in the past, in 1985 and 1993, but my understanding is that there is a third one ongoing as we speak, is there not? Also, my concern is that we are reinventing the wheel a little in looking at issues that have already been considered by experts in the field who have rendered some opinion. I think it behoves this committee to be cognizant of that opinion so we don't continue down a road that's already been pursued. It is in that regard that I'm asking for that.

Also, like Dr. Bennett, when I went out during the election, I heard a lot of feedback from herbal manufacturers and other people involved with the products who had a lot of opinions on those reports, much of it laudatory, I might say.

I would like to be privy to that information as well.

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Again, if we're going to go into this in great detail, I don't want to pre-empt the chair or the agenda, but Ms. Carman, you did provide and I'm thankful for information on the cost of obtaining a DIN. When we do move a herbal product from food, as we've discussed this morning, and bring it in under drug, there is then the cost of a DIN. It is something I have heard a lot about.

I'm looking here...and since we're not talking about a drug containing chemicals—I'm assuming we're not—I shouldn't be focused on a minimum fee of $143,000, and I'm not, but rather I'm looking at $720 for the labelling dimension and then $500 under notification and marketing.

Is that roughly what is fair to assume, that a manufacturer—and in my area we have small manufacturers who want to bring forward garlic oil or something along the lines of what we've discussed earlier—is looking at approximately $1,300 to meet your regulations to label and to market? My sense is it's much more prohibitive.

The Chair: In order to have time for an answer, would you cut it short? There's no time for advancement.

Ms. Aileen Carroll: I will leave you time for the answer, because it's you who has the—

The Chair: You've lost your time.

Ms. Aileen Carroll: —information, but I'm just going to mention that Mr. Michols has said that we're looking at making herbal remedies available and allowing Canadians to make an informed choice. If we have made the cost so prohibitive, I find it difficult to see how they are going to make that choice. These products don't come under drug plans, obviously.

Could you talk to me about the cost?

Ms. Mary Carman: Okay. If you wanted to make a claim for a garlic tablet and you wanted to sell it as a drug, you would attach a cheque for $720 along with your application and send it in. Once you received your DIN, annually after that there would be a $500 charge.

Ms. Aileen Carroll: Annually?

Ms. Mary Carman: Annually.

Ms. Aileen Carroll: If you say, well, instead of 100mg I'm going to do one with 50mg, it's double, isn't it? It's $720 for every type of garlic oil that I put forward—

Ms. Mary Carman: Under the current policies and regulation, every strength you are marketing, under a different dosage, even, has a separate DIN and separate registration.

Ms. Aileen Carroll: So this is where the cumulative effect of the DIN builds on the manufacturers. It's probably in this area of strengths and—

Ms. Mary Carman: Strengths are more of an issue with some different practices, such as homeopathic medicine, where there are broad ranges of dilution. We have addressed that with the homeopathic industry, and I'm sure someone will be presenting to you on that matter, where there are dilution ranges of the same ingredients.

Ms. Aileen Carroll: Okay.

The Chair: I was pushing you too hard.

Ms. Aileen Carroll: No, you don't push me hard. I just talk fast, so don't worry.

The Chair: I was trying to cut you off two minutes early.

Ms. Aileen Carroll: That's fine for now, and thank you very much, both of you, for your additional help.

The Chair: Ms. Caplan.

Ms. Elinor Caplan: Thank you. I approach this as someone with no expertise whatsoever in this area, and not from the aspect, really, even of someone who has knocked on doors and had the questions asked—which I have, but as a consumer.

I use the products, and so I'm looking at it from the expectations of Canadians like myself. My expectation is that if I buy a product, it is what it says it is—when I buy food, there's a label on it that tells me all of the ingredients that are inside, and so I'm used to that and I look for that—and also that it is safe. I know that's the role of Health Canada.

As for the issue of efficacy, I'm kind of in the position where if it's a prescription drug, its efficacy has been proven. If it's a non-prescription drug, then it may be up to the individual or there may be a healthy dose of the feel-good. But if it works for me, it works for me, and there may not be the body of knowledge and research and so forth. So what I'm looking for in a regulatory environment is if you, the manufacturer or the distributor, make a claim that your product is going to do something, my feeling is you're the ones that have to prove it. If as a consumer I'm told there's a therapeutic benefit, then I'm interested in knowing what is the toxicity or the risk of harm—that's the way I would look at it—and what kind of labelling information is available for me to make an informed decision.

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Is that a reasonable expectation of what the regime is today?

Mr. Dann Michols: I think it is. Certainly it is the requirement of the manufacturer or the sponsor in whatever way to provide the proof that the product is effective, as you have said.

I guess the question before the standing committee is whether or not there is a role for the regulator to validate, if you like, that particular claim to effectiveness. Some people are in a position where they can do the research and they can determine the product is effective. All they need is the labelling information saying it is what it is and it's a quality manufacturer.

Ms. Elinor Caplan: When I talk about effectiveness, I was referring only to prescription drugs.

Mr. Dann Michols: The regime in place in Canada at the moment has us responsible for safety, quality, and effectiveness of prescription and non-prescription products.

Ms. Elinor Caplan: So if we are narrowing it down, that is the issue before us: what your role should be in the area of effectiveness for non-prescription drugs.

Mr. Dann Michols: I think that is one aspect of it, yes.

Ms. Elinor Caplan: I want to understand. Safety and quality are the two things I as a consumer...I'm assuming the majority of Canadians would agree.... The issue of proof of effectiveness for non-prescription drugs or remedies or products that make a claim is where the debate should be focused. Is that your sense of what we are doing at this committee?

Mr. Dann Michols: That is certainly one of the issues before the committee.

Ms. Elinor Caplan: And what do you think the other issues are?

Mr. Dann Michols: If the regulator should not be involved at all in the issue of determining the effectiveness, or validating, if you like, the effectiveness of a product, that is one thing. If the regulator should be, then what are the standards against which that effectiveness should be determined?

Ms. Elinor Caplan: But that is still related to effectiveness. Are there any issues outside of the effectiveness issue that you think we should be dealing with before the committee right now? Or do you think there's general agreement on the issue of labelling and safety and quality?

Mr. Dann Michols: I guess the way I would choose to answer that is to return to the experience we have had recently with the advisory panel on natural health products that has been set up. It is composed of a range of stakeholders from across all aspects of the sector. The consensus that seems to be developing—and I don't want to put words in their mouths until they present their report—is there seems to be general agreement that there should be standards for safety and the mechanisms to determine they are met and there should be standards for quality and mechanisms to determine they should be met.

I think also there should be standards for effectiveness, but what those standards are and how one goes about determining what they are against a range of products with different risks, be they prescription or non-prescription, be they non-prescription pharmaceuticals or natural health products or homeopathic products or traditional medicines, what the standards are and how those standards should be determined....

Ms. Elinor Caplan: Given the lack of standards for every other medical procedure, I would be interested to see the same kind of approach attempted with all the interventions that take place in health care. I think that is where people are upset. They get a sense that you are picking on the non-prescription remedies and products and attempting to apply standards we do not apply in the treatment and the care people receive.

Mr. Dann Michols: Thank goodness I don't have to worry about regulating treatments. I have only drugs and medical devices.

As Mary mentioned in her presentation to the committee last week, a risk is also involved in taking a medicine that does not do what it says it would do and not taking a medicine or some other treatment because of it. I think it's important that both sides of that risk, if you like, the risk of the medicine and the risk of not taking other medicine, are taken into consideration.

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Ms. Elinor Caplan: That's the whole issue of risk of harm. There are a couple of different approaches on that one where you warn or find other ways of informing people. If the risk is that great it becomes prescription. Is that correct?

Mr. Dann Michols: Potentially, but it is still incumbent upon the regulator to examine the data package to determine exactly what the benefit is, what the risks are, what the relationship is together. Until we get that package we don't know whether to put it in prescription, non-prescription, or whatever. So you need the data package to make that evaluation.

Ms. Elinor Caplan: Thank you.

The Chair: Thank you.

Mr. Elley.

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

During the election campaign there were probably two issues that seemed to surface around this greater issue. One issue was that Canadians felt they did not have the freedom to choose the remedies they had taken for years that were on the shelves of our health food stores. The second was the issue that somehow the multinational pharmaceutical companies were driving this whole thing and at the end of the day the pharmaceutical companies would take over this industry, as they have taken over in the drug area. And when we moved foods to drugs, consumers were going to have to pay a whole lot more and some kind of monopoly effect would cause this.

I have two questions in this area for clarification. First, can you give us a list of the foods that have been taken off the shelves of our health food stores? Who in your department makes the final decision to do that? With all the review boards and committees giving you input, who is the person who makes the final decision to do that? Where does the buck stop?

Second, can you say categorically from your experience that the multinational pharmaceutical companies do not exert pressure on you in those decisions or have not pressured you in any way through this whole process?

Mr. Dann Michols: Let me respond to the second question, and I'll leave it to the representatives of the food directorate to respond to the first.

I cannot guarantee that the multinationals or anyone else don't attempt to exert pressure upon us. I can certainly guarantee that pressure does not influence us.

Dr. Harry Conacher: If it's a food and it's considered to pose a risk to human health, we are the ones who make the recommendation that something be done about preventing exposure of consumers to that food. We do that not only for herbs and botanicals but for all foods on the market. We set guidelines and regulations. We use a multitude of mechanisms to ensure that exposure to that food is kept to a minimum and consistent with a health hazard. We are the ones who do that.

You're asking for a list of foods that have been taken off the shelves. Do you mean foods or herbs and botanicals? What are you asking for?

Mr. Reed Elley: Here's an example. I went into a health food store in my riding and the owner said people had come in from the department and taken products off his shelves.

Do you have a list of the products that have been removed from health food stores in this country?

Dr. Harry Conacher: I must try to explain this first. There are two groups of inspectors. There are drug inspectors who take action depending on whether there is a claim associated with a food product. There are food inspectors who take action dependent on whether it is considered that food product would pose a hazard to the health of the consumer. It is difficult for me at the moment to understand what set of inspectors were involved.

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Mr. Reed Elley: You have two lists that you're going to make available to us?

Dr. Harry Conacher: We have the list of herbs and botanicals that were identified by the two expert committees as being herbs and botanicals that should not be sold as foods. Certainly we can make those lists available to you. Those lists will be present in the reports of the two expert advisory committees that are presently in the hands of the researchers of this committee—those two reports—if these are the lists you're looking for.

As time goes by, in the food area we are asked to provide an opinion on the safety of a number of those products that may be out there on the market. We provide an opinion. It could be to the manufacturer, to a consumer, or to our own inspectors or the inspectors we formerly had who are now in the Canadian Food Inspection Agency.

On the basis of recommendations we make, those products may or may not be taken off the market. Maybe some other mechanism is put in place to ensure that the consumer isn't exposed to them.

Mr. Reed Elley: You talk about an expert committee that has recommended that certain things be classified as foods or as drugs.

Dr. Harry Conacher: I made a presentation early on in this meeting today where I talked about schedule 705. Schedule 705 comprises, among other things, a list of herbs and botanicals that should not be sold as foods. On those expert advisory committees there were manufacturing representatives and university people who are knowledgeable in this field, and they came up with this list. This list was then supplemented through the various consultations that ensued.

Mr. Reed Elley: In what year did they make those recommendations?

Dr. Harry Conacher: In 1989 and in 1992.

Mr. Reed Elley: So for five years you've had no update on that.

The Chair: Mrs. Ur, did you want to ask another question? You're the last one on the list.

Mrs. Rose-Marie Ur: Okay, just a quick question. I wanted to be the last person because it's kind of off topic, but I've sat here for four hours, two hours before and two hours now.

Where are the hemp regulations?

Mr. Dann Michols: That's a question I ask daily.

Mrs. Rose-Marie Ur: Me too—hourly.

Mr. Dann Michols: We are in the process of drafting the regulations. It's an interdepartmental operation that will involve Agriculture, the Solicitor General, and the RCMP.

Mrs. Rose-Marie Ur: I'm aware of all that.

Mr. Dann Michols: We are driving hard to be able to introduce those regulations for the upcoming growing season.

Mrs. Rose-Marie Ur: I would certainly appreciate that, and my farmers would as well. Thank you.

Mr. Dann Michols: I understand.

The Chair: I'll take the other part of your question. I just have a short question.

If one accepts that natural health products need proper identification, standardization of the product as well as the appropriate guidance for use, could this be achieved through other means than government regulation? Is there a role for voluntary standards?

Mr. Dann Michols: Absolutely. In all of the endeavours we attempt to put into place vis-à-vis drugs and medical devices, there is always a role for voluntary standards. If they can be set up and if there are organizations that will develop those standards and then police those standards, if you like, that certainly makes our job as the regulator much easier. I think at the end of the day there will still be the requirement for the regulator to ensure that the voluntary process has worked as it should.

The Chair: Thank you very much. Thank you for staying the extra time. We certainly will be calling you back a little bit later.

The meeting is adjourned.