HEAL Committee Meeting

STANDING COMMITTEE ON HEALTH

COMITÉ PERMANENT DE LA SANTÉ

EVIDENCE

[Recorded by Electronic Apparatus]

Wednesday, May 13, 1998

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[English]

The Chair (Ms. Beth Phinney (Hamilton Mountain, Lib.)): I call the meeting to order. This is the Standing Committee on Health, Wednesday, May 13, 1998. It's our 41st meeting, and we are studying natural health products.

These proceedings are being televised. It's not going on live right now, but CPAC is televising it for future showing.

We're pleased to welcome back the Advisory Panel on Natural Health Products.

I think we've seen you once before. We're very pleased to have you back. We're glad we have your final report. We are passing the speaking notes of Dr. Chandler first. When he's finished speaking, we will hand out the actual report. That's the way he's asked that it be handled.

On the panel we have Dr. Frank Chandler, the chair; André Gagnon, a member of the National Association for Natural Health Products; Dr. William LaValley, founding president of the Canadian Complementary Medical Association; and Dr. Mary Wu, director of the Toronto School of Traditional Chinese Medicine.

Dr. Chandler, would you like to go ahead, please.

Dr. Frank Chandler (Chair, Advisory Panel on Natural Health Products): Thank you very much, Madam Chair and members of the committee.

It is a pleasure to be able to come back to the group today and present the outcome of our deliberations over the past year. As you mentioned, we do have our final report ready for you, hot off the press. The last revisions were made about an hour ago, but it does reflect the year's study that our panel has put forward.

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Although we have consensus on some issues, we do not have consensus on all of them. I will draw your attention to that as we go through. We have one member who has not agreed to the full content of the report. Other than that, the other 18 have given their consent to the report you have in front of you. I think reflecting on the great diversity of backgrounds we've had and the interest we've had on the panel, to have 18 out of 19 say they agree with the content of the report was a small miracle in itself, as I'm sure you're aware after having had 41 meetings on this topic now.

It's been a learning experience I think for all of us on the panel. I think everybody has learned a lot, grown a lot, and given a lot in coming up with this final report.

The French version you have in front of you has not yet been edited for accuracy. It will be done so in the next day or two. Once that is complete, both the English and the French versions will be going up on the TPP web site. It will be fully accessible to all those who can access the web.

I will be following the handout, the speaking notes, that have been distributed. They do cover most of the issues within our report, certainly the major ones. They do not follow in context or chronology the report. That's why I'd just as soon the report remain on the desk until we've finished talking about it.

As I started off by saying, we've had vigorous debate on just about every issue. We've heard very many viewpoints, and in the end we've had consensual agreement on quite a number but disagreement on some.

I think it's important to point out, because I know you members of the standing committee know that the panel at times wondered if we were being led to some degree by TPP and their people, in the end the panel did tell me to express both in writing and verbally today their great gratitude for all the information and service they had provided the panel. In hindsight they could see where the information we needed to frame our final report had come from.

The report you have in front of you was the outcome of our last two-day meeting and was drafted initially by an external writer to TPP and to all of the panel members. After she had crafted draft one from our last meeting, we went sort of Internet with it again and had two other members rewrite significant portions of it. In the end, all 19 people saw that final version. As I said, 18 have signed off as agreeing to the content.

The panel did focus largely in the end on products in dosage form and marketed as natural health products for human use. We are aware of the fact that a lot of these products could be used for veterinary medicine. We did not feel that was part of our mandate.

We also wrestled for some time with the issue of bulk herbs. We were unable to come to a significant decision on that, other than we are concerned about the quality, the safety, and the identity issues of bulk herbs and recommend that something be done with those as well. We had enough on our agenda at the time to try to come up with some reasonable recommendations dealing with those products in dosage forms.

There are other products in bulk that we are also concerned about, such as amino acids, proteins, and similar products used by athletes for bulk building and what else they might use them for. Those do not come in dosage forms unless you call a measuring device a dosage form. Those also need to be looked at.

There are also some specific paradigms or philosophies that anybody making regulations about needs to be cognizant of, and that's the traditional herbal medicines as practised by many of the cultural groups, particularly traditional Chinese medicine. They do have special considerations in the way they combine herbs, as do many of the other cultural groups. We need to be cognizant of that information in making any final recommendations on bulk products.

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We did consider all other health products, as you remember from our first presentation, including neutraceuticals and functional foods, but in the end our recommendations deal specifically with those products in dosage form and, as I mentioned, with implied or explicit use for human use, in wellness and in illness.

Our objective was to create a regulatory framework, or make recommendations on such a framework, that ensures consumers have freedom of choice, ready access to products that are safe, are of high quality, and whose claimed benefits are supported by reasonable evidence.

We started off initially by dealing largely with quality, and I think the panel is unanimous that if we could guarantee the quality and identity of these herbs, herbal products, or natural health products, we would have moved major mountains in protecting the consumer health of this country. We then got into safety and efficacy issues, which we were not quite as clear on.

I think it's important for me to mention, as I had to frequently with the panel, that our outcomes must be in the best interest of the Canadian consumer and protection of public health.

I should point out that the panel was composed largely of those with inherent commercial interests. I think 13 of the 19 run businesses of one form or another, whether it's traditional, as a practician, or manufacturing or distributing herbal products or health food products. They did have commercial interests. However, in their defence I have to say that every now and then, after I tapped them on the shoulder and reminded them of this, they were very cognizant of the outcome of their deliberations and the need to have safe, quality products for the consumers. So although we had what appears to be a great imbalance, I think the panel dealt with it quite well.

In making any sort of recommendations, you do, I believe, need to take into consideration both the consumer and the industry. We are quite concerned about costs, and of course costs levied against industry get passed on to the consumer, so any recovery fees, licensing fees, and so on need to be dealt with specifically for this group to make sure that it is indeed cost recovery and not any more so.

The panel maintained throughout, and continues to maintain, the position that natural health products are really neither foods nor pharmaceuticals—I have drugs down there, but that's the old definition—and that these natural health products do indeed fall somewhere in between, both in function and in control. The current regulatory framework, we believe, needs substantive revision to meet the unique aspects and properties of the natural health products.

The next slide shows the definition we worked with during our deliberations. It may not be perfect. It took us some time to get to this definition, but it did help guide our discussions, and the major change in our definition from last time you saw it is the portion sold in dosage forms. We are interested in products for the purpose of maintaining or improving health and for treating or preventing diseases or specific conditions.

Dealing specifically with framework factors, we feel with this group of products the legislation that will ensue needs to be more permissive, rather than predictive or prescriptive, that interventions need to be on the minimalist side and need to be very directly correlated with the relative risk of any of the products. We believe administrating any legislation that is put in place needs to be guided by a group of specialists.

This has been a major concern of ours throughout, that TPP needs additional specialists to deal specifically with these products. We feel that, even there, the administration needs to be guided by specialist committees that contain on them the practitioners using natural health products, including various herbalists, naturopaths, medical practitioners, people practising cultural-based medicine, pure scientists, toxicologists, and pharmacologists.

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We have also pointed out in our regulations throughout that the specialists in most jurisdictions are not defined. This is a problem, because as you're well aware, this is a provincial jurisdiction. We have a recommendation in our report that you do something about that, such as calling a committee meeting with the drug plan advisers, or whatever they call themselves. There is a provincial-territorial committee or something that deals with this sort of material.

The provinces do need to start looking at bringing into place some sort of regulation of these different practitioners, whether it's self-directed or government-legislated. We do need to assure the public that the practitioners who are out there practising do have the qualifications necessary for the different levels of administering natural health products. We also will probably write those same people a letter encouraging them to do likewise.

On the administration, the panel was also concerned that the actual administration not have the power to overrule the decisions of any specialist advisory group as to the safety, efficacy, and quality of these products. Such an administration would overrule those advisory committees only when a product for approval would compromise significant Health Canada policies. The experts can deliver the practice knowledge for the product and the administration needs to be left with the administration.

In number 9 we assert some of our beliefs, helping us, again, frame our framework. We continue to believe that natural products are for the large part inherently safe. When we were looking at trying to construct our framework, we felt the dosage forms, the claims, and the relative safety of the products should be the cornerstones of any of the legislation. For the most part, we felt that where risks might exist, they could be managed by proper labelling and proper professional intervention. Again, we come back to the controlled professional.

Risk management relates specifically to about four different items, in our minds.

Number one, you need good manufacturing practice for these products, and it needs to be addressed specifically for these products.

The panel is quite strong on the fact that we need specific regulations somewhere in between those of foods and pharmaceuticals. Pharmaceutical GMPs in some cases may be too rigorous, and those for foods of course are voluntary for the most part and not applicable to this group.

We do recommend establishment of licensing for this industry. Again, that's a factor in the quality and risk management of these products.

Proper labelling as to the identity of the product, how it's to be taken, contraindications, and so on are also risk management tools. Again, we refer to the health practitioners.

Slide number 11 deals with framework factors and linked framework changes. This is getting into some of the nitty-gritty we felt was necessary to start to bring about our framework.

First of all, the word “drugs” in the act should be replaced with the phrase “therapeutic products in dosage form”, and that group should then be expanded to include products used in the maintenance of wellness.

The therapeutic products in dosage form would then be subdivided into pharmaceuticals and natural health products. Pharmaceuticals would be largely as they exist today, under the banner of drugs, and natural health products would be as per our definition. Obviously there's some overlap, and we need to sort out some of the tools that would be necessary to make sure the products get steered into the correct management process.

Dealing with the regulatory authority, the regulator must be independent of other interests and influences, particularly other administrative regulatory bodies within Health Canada. We want a group that can make independent decisions without undue influence, but certainly in collaboration with other groups.

The panel agreed that natural health products' regulatory administration should be distinct and separate from current food and drug sectors. That group needs to interpret and implement policies such that they do not exclude culturally based practices such as TCM.

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With the panel we quite often got off on a tangent, as Mary will attest, looking more at the western practice. We then had to stop and rethink some of our decisions based on the way some of the culturally based products are used and advised by the practitioners. This needs to be kept front and centre in your thoughts when deliberating on any possible regulatory changes.

When it came down to who should do the work, that's where the panel had some of its longest, more vigorous debates. At this point they were well divided on who should do the administrative work.

We discussed three different possibilities. One is having a free-standing agency totally outside Health Canada. A separate second option would be to have another body—the word “bureau” got bounced around—within Health Canada, and yet others felt that these could be managed from inside TPP as a separate unit. Given the right expertise, the right structure, it could be managed within the existing framework of TPP.

We had another lively series of debates on claims and how to give consumers enough information for intelligent use of these products when they're picking them off the shelf, particularly those products that would not be guided necessarily by a practitioner.

We have agreed that three different types of claims should be allowed: structure function claims, risk reduction claims, and treatment claims. Those are all gone into with examples in the text itself.

Those were agreed to, I think, by all members of the panel. The issue that did draw some very vigorous disagreement from a small number of the members of the panel was whether products should be allowed on the market without claims at all. Again in the report we put some of the arguments forward on the pros and cons.

The panel did agree that explicit claims were desirable. They disagreed that they should be mandatory, and that's where the disagreement was. Some panel members felt the claim should be mandatory. Where we were in agreement again was that even if these products are out there without claims, they should still meet the same quality and safety standards of all other products on the Canadian market.

When it came to marketing, we divided the groups into two categories. It would allow probably a large percentage of the natural health products out on a post-market notification basis, where recognized monographs or standards could be attested to. Of course one of the shortcomings at the moment is that we do not have recognized monographs or standards in place. We dealt with that a little bit in our report, but there are many in the world at the moment that I think Canada could look at and could conceivably adopt, at least in the short term, to alleviate quite a bit of the marketplace mayhem that could follow from some of these decisions. Assuming those proper monographs and standards are there, attestation to them would put the product on the market.

Only manufacturers holding a recognized establishment licence would be allowed to proceed through this route. Again the labelling specifications need to be laid out in detail and with uniformity.

All other products would be required to go through pre-market submission for review. We're not proposing the same rigour that you would find for a potent pharmaceutical but some reasonable evidence to support that it's safe and effective. Of course quality is an issue with all of these products.

Any product for which there was no standard or monograph would have to go this route. Any new product obviously would go this route. Establishment licensing would be required, as well as appropriate labelling. In the text of our report we talk about the sort of evidence we feel would be appropriate. This includes such things as pharmaceuticals normally go through, but also adding to that the use of traditional references, professional consensus where that would exist, and similar sorts of information that would come from a group of experts, which could be agreed upon by an advisory panel of some sort that, yes, if it meets these standards and expectations, then these are reasonable claims and functions to put forward on a product.

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We'd like to see some leniency in that area for bringing products to market where a reasonable amount of evidence in traditional or traditional practice exists.

We dealt with combinations as well. Basically our policy is if the products in the combinations meet the high safety standards and can go through attestation, then they can go that route. If they do not, then they follow the same pattern as the others, obviously through pre-marketing.

Again, combinations are a major concern for many of the culturally based paradigms and particularly traditional Chinese medicine. Looking at them as a scientist, they don't always make too much sense, but when I hear some of the philosophy and rationale behind them, then they do start to make some sense. So we need to keep these practices in mind when we're making legislation.

In our discussion, we have decided amongst the panel that some of our current legislation is outdated and needs to be rescinded or emptied or changed, however we might go about it. Of course we are somewhat concerned about doing that immediately. We'd like to see some of these things change immediately, but we also are aware of the fact that you need some sort of interim policy to cover any chaos that might be created by doing that. So there needs to be—and I'll address that in the next slide—careful thought to what happens in the interim, from today, basically, forward, until such time as a new policy and new legislation may be in place.

Three specific things we address in our report are schedule A, and I think you've heard that many times before. We feel it's outdated and needs to be rescinded or emptied as quickly as possible. This would allow for a lot of claims to be made that I think are appropriate and would help the consumer.

The traditional herbal medicine policy is a concern for a number of the people in the industry as well and needs to be either revised or rewritten entirely.

The sampling clause: a number of people on the panel felt that sampling restrictions as they exist at the moment are too restrictive for this particular group of products, and they'd like to see that addressed.

Those are three sections that we were able to identify that need some immediate attention in both the way they're managed and for the future.

As I mentioned, interim measures are a major concern to us. These products are on the market. We want to bring some order to them, and we need to be fair to those people who are on the marketplace. We need to be fair to those who are trying to meet the standards, and we need to do this in somewhat of an orderly fashion. André, I believe, would like to address that issue specifically, at the end of my introductory comments.

When you have products out there, if you decide they're going to have to have a particular label on them, there's going to have to be an implementation time. You can't do it overnight, obviously. The industry is quite concerned about that because of the costs involved with labelling and quality control issues and so on. To take them all off the market tomorrow I don't think serves the consumer well, either. We need to address that in the future.

My last comments deal with stakeholder involvement. We believe representative industry, practitioners, and consumers must be involved in drafting new regulations. Some of our terminology in the report is rather strong, but we do feel that these groups all need to continue to be consulted or be part of the actual drafting teams.

As my final comment, many of us are up to our necks in this process at the moment, as are you. A number have specifically said they would like to remain involved in ensuing deliberations, and the rest of us I think are there by default.

Madam Chair, those are the opening comments I have for our report.

The Chair: Thank you very much, Dr. Chandler. Do you have anybody else on the panel who would like to speak?

Dr. Frank Chandler: I think André wanted to address the issue of the interim process.

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The Chair: Mr. Gagnon.

Mr. André Gagnon (Member, Advisory Panel on Natural Health Products): This item is very important.

Incidentally, about a week ago I received a letter from an inspector in Quebec stating that four or five of my products were illegal. I know that. The point is the enforcement of the regulations right now is done through complaints from either the consumer or competitors. So it seems I have some nice competitors in the province of Quebec who file complaints to TPP, the food division, or whatever.

If I have to change my labels to be in accordance with the existing regulations, I don't want to be the only one to have to do so, and because there's limited manpower in terms of inspectors, that means the enforcement cannot be done in an equitable way across Canada. What I can do tomorrow is file about 100 complaints myself against the other competitors across Canada who do the same thing I do—which is why we're here. If I do that, what will happen? It will be another bomb, and we don't need that. The same thing will happen that happened last year. A lot of companies will have a lot of dissatisfaction, they'll talk to their MPs, and we'll again be in the same situation.

There might be some solutions for that, and I've talked to some people in TPP. Meanwhile, in the interim, there is a very simple example. We know, for example, you cannot advertise a product for prostatitis. My product has a name that reminds us of prostate, but they say it's a schedule A disease. I told them if you talk about the disease, it is on schedule A, but if you talk about the structural function of the organ, there might be a way in the interim to grant a DIN, meaning they would interpret schedule A more openly, in a more flexible manner.

It might be technical, but my point is if in the interim there's not enough tolerance, there will be no choice, to be on an equal level in competition with others, but to make complaints about all the other competitors, and we don't want that to happen. So we need to discuss openly with either the food division or TPP how we are going to resolve that situation in the meantime.

That's what I have to say on this one.

The Chair: Thank you, Mr. Gagnon.

Is there anybody else, or can we go on with our questions and comments will come out from there?

Okay, I'd like to thank you very much. I think we on the committee understand how much work you went through to even come to this. We're going to hand out your report now to all the members, and members may direct their questions to anybody on the panel they would like. I haven't had anybody say they want to ask a question yet.

Dr. Hill.

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

I'd like to say thank you for all your work as well. I know it's been an immense task.

The Chair: Could I just mention that there are five minutes for the questions and answers? The member might have another question to ask, so keep your answers to the point, if you could.

Mr. Grant Hill: I always like to try to have a practical example, so I'll give you the one I've used quite often. What would happen to melatonin within your framework, the way you've laid it out here?

Dr. William J. LaValley (Member, Advisory Panel on Natural Health Products): Clearly, it would be described as a natural health product, as it exists in nature and is a non-patentable molecule. It would be subject to pre-market review because it would be considered new, and there's no standard or monograph that specifically has attestation to that.

It would then go to the review process. At that time, it would be very important to consider the expertise of the people who are making the assessments, how the product claim is being introduced, and in what administrative way that will be processed.

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It specifically then leads us into the whole discussion of what sort of administrative body and what kind of underlying expertise and working groups would be addressed in this fashion. If you would like me to go into that, I will. I'd be very happy to do that because I think that's really the core of what we're here for.

Mr. Grant Hill: That's probably too deep in terms of detail for this discussion. But from this structure, what would happen with ma huang as another example. I've chosen the two products because one is fairly new and one has a historical background to it. I've done that on purpose.

Dr. William LaValley: I would prefer to let my colleague Dr. Wu answer that.

Dr. Mary Wu (Member, Advisory Panel on Natural Health Products): I'll say a little about ma huang, because it apparently is used both ways. One is the traditional, culturally based way according to the philosophy of traditional Chinese medicine, and the other is the western herbal way. In terms of evaluating the products of ma huang, or ma huang containing combinations of products, they should be evaluated separately.

Traditional Chinese medicine products rarely use a single herb. They are usually combinations of these herbs. The combination is formed according to the theory of traditional Chinese medicine. Therefore, with the monograph that is a recognized reference among the traditional Chinese medical paradigm, if the formula and the products are recorded in that monograph, it should be subject to post-marketing notification, where if a combination or a very highly concentrated form of ma huang is not included in the monograph and there is no traditional reference, it should be subject to pre-market evaluation.

So the two types of products should be evaluated separately. They are used in two different categories in terms of their safety and risk.

Mr. Grant Hill: Would a product that had a historical use and a long history be easier to get back on the Canadian market than a product that was new and might involve some scientific controversy? That was really the point of the two examples.

Dr. Frank Chandler: The short answer to your question is probably yes, a product with a long history of use would be easier to put back on the market. You might have picked what I would call a wrong example, because it does have some significant toxicities if used in large amounts, inappropriately, or even by certain segments of the population that have heart disease, for instance. They can get themselves into trouble.

My guess is that herb would probably wind up in our lower safety category, which would mean under the supervision of a practitioner. Until you sit down and draw up the actual guidelines, it's hard to say, but that would be my guess. But certainly, by our recommendations, where the product has a long history of consistent use for a particular reason, and safe use for that reason, it would find its way onto the market much easier.

The Chair: Ms. Wasylycia-Leis.

Ms. Judy Wasylycia-Leis (Winnipeg North Centre, NDP): Thank you very much, Dr. Chandler and all the representatives here today, for the very detailed report.

I would like to begin by mentioning that you made an important acknowledgement at the start of your presentation that the panel is primarily made up of individuals who have commercial interests and you may not have a pulse in terms of what consumers are saying. We've certainly had an earful over the last four months, and I'm sure you've heard representations yourselves.

When you were established as a panel to look into this matter, was there any provision made for you as a panel to take your report out to the broader community to seek input at all? I'm wondering about that in the context of the work we have to do.

Dr. Frank Chandler: Just to clarify my introductory comments, while the majority of our panel has direct commercial interests, quite a number of those also have direct input or feedback from the consumers. I think we had a pretty good handle on it and had pretty good feedback from consumers to that group.

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The mandate we had initially, when David Dingwall was Minister of Health, was to do what you're doing now, to go to the stakeholders once we got our report done and then get the feedback. After the election, when Allan Rock came in, our mandate changed somewhat, and you received, thankfully, that task. Our mandate then shifted somewhat in that we still reported back to TPP, but we were also asked to communicate our findings to this committee.

Ms. Judy Wasylycia-Leis: Thank you.

My second question again comes back to some of the feedback we've been getting through the presentations and hearings. As you know, we've heard an earful from some consumers who believe any attempt to go down the path you're recommending will be tantamount to killing an important area in our health care sector, in our health care community, and will be bureaucratic, will be costly, will put small retailers out of business, and will deny people choice.

Given that you've now come up with your final report, I want to know how you can help us address some of those concerns. Can you specifically give us some information on what kind of cost-recovery fee structure you see, based on the requirements you've laid out in terms of licensing, post-market, pre-market approvals, DINs, and all the rest? What would that mean in terms of cost? Do you have any understanding yet of what that would mean in terms of cost to a product?

For example, we have heard from many that in Germany, where we've a highly regulated scheme, we've had vitamin C go from $6 a bottle to $26 a bottle.

I'm wondering if you can answer some of those concerns and questions.

Dr. Frank Chandler: Let me try first, and then some of my colleagues might want to add comments.

I've been out on the talk trail lately, and I've been talking not only to pharmacists but also I've had the joy of talking to two consumer groups in the last couple of weeks. One big misconception I find amongst the public is that the minute you start talking regulation, they read restriction. Once you get by that hurdle, when they find out that products on the shelves are not controlled through any type of guarantee from Health Canada that they are safe or effective or even are what they say they are, then they realize the dynamics of the problem and can see where we're going.

In that light, I think they're concerned about costs but want to make sure they have quality product when they are investing, and would feel happier about investing a little more in a quality, safe product than they are in the marketplace today.

To address the fees specifically, we've not dealt with the actual structure or size of those fees. We have recognized the fact that there will be a need for an establishment licensing fee, and there will probably be product licensing fees. Other than the fact that we've asked for people looking at this in the future to be cognizant of the actual costs this would bring to the consumer, and to try to make them reasonable in cost-recovery situations, we have not actually addressed how many dollars and cents there should be. We just didn't have time to get to that level in the discussion. But we do want to keep them down.

The Chair: Your time is up, Ms. Wasylycia-Leis.

Mr. Volpe.

Mr. Joseph Volpe (Eglinton—Lawrence, Lib.): Thank you very much for the presentation.

On page 4 you talked about it being supported by “reasonable evidence”. Is the word “reasonable”, in your mind, interchangeable with “scientific”?

Dr. Frank Chandler: Not exclusively. We wrestled with this one. Scientific evidence would certainly be acceptable, and clinical trials acceptable, but we feel there are volumes of literature and knowledge out there, accumulated through generations if not centuries of practice, that could also, for many of these products, be very reliable.

In fact, the traditional herbal medical policy that's in place today will allow a manufacturer to bring forward information from traditional sources that say a product has been used by x generations of people for this particular reason, and from what we can see in the literature, there's no toxicity associated with this product.

So that's the type of thing we're looking at.

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Mr. Joseph Volpe: When you're talking about the literature, though, not all the literature is accepted by everybody.

Dr. Frank Chandler: That's right.

Mr. Joseph Volpe: Do you have a list of the literature that's acceptable?

Dr. Frank Chandler: Again, we did not have time to get into that. We recognized that some of the literature is much better than others, even in the scientific community, and that we would like to see an advisory panel or a standing committee or some type of panel of experts that would judge these and then have them available to the administration that's looking after them.

Mr. Joseph Volpe: On page 8 you talk about the administration guided by specialists. I think you made reference in your presentation to the possibility of regulating those who administered these NHPs. I think you acknowledged as well that generally, that is almost exclusively a provincial jurisdiction. What implications do you think that has for the federal jurisdiction?

Dr. Frank Chandler: It's going to make it difficult to make the regulations we're recommending work unless you can get provincial governments on side to bring in some regulation of the practising industry.

André?

Mr. André Gagnon: Again, if we're talking high-safety products, the problem is not there; it's when you're talking about products of lesser safety.

Mr. Joseph Volpe: That brings me to my next question. Your natural health products cover a broad range of different types of products—homeopathic, western-based, culturally based, as you call them, such as typical Chinese medicine approaches, vitamins, you name them all.

Do you think it's going to be manageable to regulate this? Can we do it? Can it be done, in your own mind?

Mr. André Gagnon: Whatever we do is better than right now. Right now the products are out there.

Mr. Joseph Volpe: No, right now there's a regulation, but it's very specific. You're suggesting something a little bit different. I'm just wondering whether we are not going to continue to have the same kinds of difficulties. The fact that you exist and we exist is a function of a difficulty that's perceived and experienced.

Mr. André Gagnon: Okay. I'll answer this one. I'll give it a shot. I'll also partly answer what Judy asked, or a comment she made, about cost and the structure.

First, to rectify something, it's true that many people involved in the panel had commercial interests, but not in the same fashion. In terms of manufacturers there were not a lot of us. There were some retailers, of course, but retailers do not necessarily have to deal with approval of DINs and products and stuff like that.

Personally, I feel that going to pre-assessments for products, not based on monographs or standards, could be a too-costly system. That's my personal opinion. Of course, on the panel there were different opinions on this one.

The point I'm making is that if the structure is too big, we won't be much better off than we are right now. So the pre-assessment thing worries me a bit.

As well, if we take structure/function claims for safe products, a way of doing it was to ask for post-market notification for structure/function claims. This way, it would really make the system less big, less onerous.

The Chair: Dr. Wu, did you want to answer that? Could you keep your answer on topic, please?

Dr. Mary Wu: With regard to Mr. Volpe's comments, the area of natural health products does cover a wide range of products—homeopathic medicine, TCM products, vitamins, minerals. With all these different types of products, we cannot make one shoe to fit to everybody's feet. The rules or the policies made for homeopathic remedies will not be a proper way to address the safety and quality issue of traditional Chinese herbal products.

Therefore, in our report we did recommend separate working groups, or to make it more clear, there are subcategories of natural health products that need to be looked at differently. Groups from the TCM society have recommended this to the standing committee, that is, taking the Olympic approach—which has different rules for different games—and having different policies for different types of natural health products.

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The Chair: Thank you very much.

Mr. Elley.

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

Again, I want to tell you how much we appreciate the amount of time and work and the effort that all of you have put into the advisory panel. It's not over yet; we all have more work to do.

I was interested to hear you say that under the regulatory authority section—and I agree with it—the interpretation and implementation must not exclude culturally based practices such as traditional Chinese medicine.

In a couple of submissions from aboriginal healers, if I recall correctly, they were very insistent that their traditional healing practices and the herbs they use in them should not be controlled at all by government, that there should be no restrictions placed on anything they do. Did you have any discussions about that when you talked about this section? And how would you handle that in this context?

Dr. Frank Chandler: We did have a member of the native North American community on our panel and she made sure we heard about this topic. We did discuss it.

In the end, a lot of the herbs they would use for cultural purposes probably would be harvested in the wild, so they would fall outside of our discussions and our recommendations for regulations.

On the other hand, I know of several bands across the country that are now trying bring their herbal products to market. Those products would then fall under these regulations. Our panel member had no problem with that concept.

Mr. Reed Elley: So once there is an attempt to market aboriginal herbal remedies, they agreed that those remedies would fall under the same kind of regulatory authority that any other product would. I'm glad to hear that.

Dr. Frank Chandler: That was my understanding from our discussion.

Mr. Reed Elley: Okay. Second, I want to ask you about health claims. Under the section of “no claims”, I understand that you had some disagreement on your advisory panel as to whether they should be mandatory.

However, you still made the statement that you felt that all products should be required to meet standards for quality and safety. Isn't there an inconsistency in that? If you're going to insist that all products meet certain standards for quality and safety—which I would think inherently gives them some kind of credence amongst people in terms of whatever they're taking this for—shouldn't you then be required to label that product with whatever standard it has been met for, with whatever claim is being made, with whatever it's being used for? Somehow I feel there's some kind of inconsistency there.

Dr. Frank Chandler: Dr. LaValley, could you respond to that?

Dr. William LaValley: It's an interesting conundrum. The issue about claims and labelling of claims is that there are a number of products, especially conventional pharmaceuticals, presently on the market and presently licensed for use, that have no claims, so it seems inconsistent to require a different standard for natural health products.

In addition to that, there are a range of natural health products.... I think of amino acids and homeopathic medicines—there are hundreds if not thousands of homeopathic medicines—where the description and the requirement of a specific claim is actually limiting to the actual use of that product and would in fact constitute misinforming the public, because the public otherwise would have very little understanding of the broad range of use this product could have.

Because of the requirement for safety and because of the requirement for good manufacturing practices applications for all the products, we are absolutely requiring these products to meet minimum standards. That safety requirement is therefore met.

• 1630

Mr. Reed Elley: We heard from many consumers on this issue of health claims and safety, and even those people who are absolutely convinced that herbal remedies, natural remedies, are safe and don't see any real problem with them are still concerned that with the proliferation of products now on the market we need to somehow have both the standards in place and the proper claims on the bottle so we know that what's in the product is really what we're getting. And I would—

Dr. William LaValley: If you look at it from a marketing perspective, I suggest that because of the marketing advantage of having a claim, there would be very few products that would ultimately have no claims. And with an appropriate new framework in place that was efficient and effective, the vast majority of products would be able to meet all of these standards and would have appropriate claims on them. That way, the consumers will be able to access them.

However, if I ask you about a particular amino acid.... How would we use arginine or ornithine or tryptophan or whatever it might be? Having only a single claim required is in fact misleading, and if we look at homeopathic medicines, where the interventions can have hundreds of uses....

Mr. Reed Elley: Yes. I understand what you're saying, and I don't know how one handles that.

Dr. William LaValley: That's the conundrum.

Mr. Reed Elley: Yes. Thank you.

The Chair: Ms. Caplan.

Ms. Elinor Caplan (Thornhill, Lib.): Thank you very much. I have a number of questions.

On the back of your report—and by the way, let me say that I think it's quite remarkable that you have achieved the degree of consensus you have—is a list of the members of the advisory panel and where everyone comes from, both across this country....

Since you've noted there are commercial interests, I think it's important to note that you had members from the Assembly of First Nations, a representative of the Canadian Naturopathic Association, the president of the Canadian Health Food Association, a representative from the Consumers' Association of Canada, a representative of the Non-Prescription Drug Manufacturers of Canada, the president of the Ontario College of Family Physicians, and the president of the Canadian Coalition of Herbal Associations, as well a representative of the Manitoba Faculty of Pharmacy, plus, of course, yourselves.

I haven't named everyone, but I think it's a very impressive and diverse list of individuals, and I think the committee members would like to know who the dissenter was. I'd certainly like to know. You said you had 18 of 19 sign on to your report. I'd like to know who the dissenter was.

The Chair: It's up to you, Dr. Chandler, to answer that or not.

Dr. Frank Chandler: It will probably come out sooner or later anyhow. It was the pharmacy representative from Manitoba.

Ms. Elinor Caplan: I think it's important for people to know where the dissent came from, particularly as this is being televised, and I think it's important for people to know that from this very diverse group, from those representing consumers, industry, the non-traditional therapies and so forth, you had a broad consensus and that the dissent was from the representative from pharmacy. Of course we heard from pharmacy directly as well. Certainly that's an understandable dissent.

Here's the question I have. You don't recommend an appeal procedure here, and I'm wondering whether that was considered by the advisory panel. You've gone through the process—and I'm using your recommendations now—and you're recommending that you have experts within the unit, wherever it is established, and that there be a procedure, either post-marketing or pre-approval, which is very different from what exists today and would help to keep costs down, particularly if it is post-marketing based on existing information.

But what happens if a product is not given approval? What role do you see for your own advisory panel there? Do you see a role for your advisory panel as an appeal panel? Do you see an appeal process? Was that part of your considerations?

• 1635

Dr. Frank Chandler: We did discuss the concept and we do mention.... I can't lay my hands on the actual recommendation, but it is covered in the executive summary at the bottom of page 1: “The regulatory framework would also include an open and transparent appeals mechanism.” We're aware of the need for that.

As far as this panel goes, our formal mandate actually concludes when we leave here tonight.

Ms. Elinor Caplan: Your contribution is a very important one to the work of this committee, and I think we would all agree that this is going to be very helpful to us in our deliberations.

Can you give me some sense of what kind of an open and transparent appeal mechanism it could be? Compare it, perhaps, to what already exists. Also, a few times you've mentioned the need for cost efficiency in an appeal process and through all of this. How do you do that while making sure it's cost effective?

Dr. Frank Chandler: Dr. LaValley, would you like to respond?

Dr. William LaValley: The whole cost effectiveness of the process really depends on how the administrative body is selected and then on how we actually access and use the expertise we have in the country. It has been suggested that there is a high-cost way and a low-cost way and a high-efficiency way and a low-efficiency way.

Perhaps this can address your concerns. I'll draw a model about this. An administrative skeleton, whether it's a directorate, a bureau or a separate agency, would basically move the documentation around and then would move the requests for pre-market approval to a body of experts. That body of experts need not actually physically be in Ottawa. This could all be done electronically, through the net, through faxes, etc. This would dramatically increase the use of expertise throughout the country and would bypass the need to have a large number of full-time people on staff as experts, which would be very expensive.

Within this working group of experts, the decisions will be made in general. If a product is then in question with regard to, let's say, a specific traditional Chinese medicine, for instance, or with regard to some of the complementary medical products, that could then be pitched to a subcommittee that was also electronically connected, which need not physically meet in Ottawa but could perhaps meet two or three times a year. That's where decisions can be made, and those decisions can be expedited very quickly. The government would perhaps be paying for what would be the equivalent of one or two staff members in order to get all of this expertise, because it's done by remote, electronically, and they only meet infrequently.

If a product is still denied, then the product could go through a process similar to that of an appeals body, which would also be constructed in essentially the same way and would therefore be able to meet all of those needs and have a highly efficient use of the expertise that exists in our country. I will submit that this expertise is otherwise going to be very difficult for us to get, because to get these people who are the experts to quit their jobs, quit their lives, and move to Ottawa to be on the bureaucratic staff of whatever this administrative body is going to be will be very difficult and very expensive.

Ms. Elinor Caplan: Thank you.

The Chair: You've been very helpful.

Ms. Elinor Caplan: Do I have any time left?

The Chair: No.

Ms. Wasylycia-Leis.

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

I have three questions, which I'll ask all at once. They're for three different people.

The first is to André Gagnon. You talked about the question of a transition approach. Is there not now a moratorium in place that deals with the situation, and could that not be extended until such time as we have a new regulatory framework in place?

My question to Dr. Wu is, how do you define dosage? Does this address the problem we talked about, both in Vancouver and Toronto, with respect to all of the different Chinese herbs and the question of each herb being licensed or regulated? I'm still trying to figure out how you deal with that problem. We heard over and over about so many herbs in a shop and trying to license each particular product. What's the definition of “dosage” and does it address that problem?

• 1640

My third question to Dr. Chandler comes back to my first point. I don't disagree with Elinor Caplan's comments about your committee being broad-based and having a wide range of interests at the table, but I still sense there's a pretty big divide in this whole area. Maybe you'll disagree in terms of how big that divide is, but I sense there's quite a difference of opinion among the Canadian public.

It seems to me it would be most beneficial if your mandate could be extended for you to take this paper on the road, explain it to all those groups across the country that are deeply involved, and help with the information-sharing communication and education. We would then be able, I think, to come up with a much better report.

I know it's hypothetical, but if we could perhaps suggest to the minister that the mandate of the panel be extended to take its paper on the road and get further input from the public, is that something the panel would feel able to do or be willing to do?

Mr. André Gagnon: Some interim measures exist right now, but mostly for products carrying DINs. There are some special measures for products that have DINs. I'm talking about products that are in the food category right now. As I stated in the example I gave earlier, in the case of those products the interim measures are not flexible enough. The law says for a food product you cannot make a claim, say anything about the product, or give it a name that reflects or gives an idea that it is for the treatment, prevention or whatever of a disease. That is the problem.

Right now there are a lot of products carrying implicit claims in their names or advertising. That's my point. Because the enforcement only works through complaints, it's not fair for everyone. That's specifically what I'm talking about. We have to discuss interim measures for products that are food right now in the form of supplements.

Dr. Mary Wu: To answer your question about the definition of the dosage forms, Judy, on page 6 of our final report it gives the category of drugs in the therapeutic products and the dosage forms. Dosage forms would include but not be limited to capsules, tablets, injectible substances, oral solutions, topical preparations such as liquid, creams, ointments, and patches and so. Those are the definitions of dosage form.

When you talk about seeing so many different types of herbs, I think you're talking about bottled herbs. Those are leaves on the shelves in Vancouver and in Montreal. Those are the traditional Chinese bottled herbs such as ginseng, dong quai, rehmannia root, and Chinese yam. Those are just a few examples—and astragalus, of course—and we use them for cooking. We treat them as a kind of dietary food. If you're tired, we add a little bit of ginseng and astragalus to beef stew and eat it. Those herbs are not in dosage forms; therefore they're not covered by this regulatory framework.

Ms. Elinor Caplan: That's similar to...you would never encompass milk, eight glasses a day, that sort of thing.

Dr. Mary Wu: That's right, and also those products do not make claims. Most of them are used by people who just go grocery shopping and buy a few packages to cook. Some of the more potent herbs are used by practitioners. So you prescribe different types of herbs and then the patient prepares them on an individual basis. They aren't sold as general health products.

The Chair: Thank you.

Ms. Judy Wasylycia-Leis: Madam Chairman, could Dr. Wu just quickly answer my other question?

The Chair: The questions are so long, we don't get time for their answers.

Ms. Judy Wasylycia-Leis: I got it all in one minute. What do you mean?

The Chair: Is it okay with everybody that she gets her answer?

Dr. Frank Chandler: I'll try to be brief. I don't want to leave the committee with the feeling the panel is greatly divided. We've certainly had our vigorous debates, but—

Ms. Judy Wasylycia-Leis:

[Editor's Note: Inaudible]...out there, the public.

• 1645

Dr. Frank Chandler: You'll get a good debate on any one of the topics, but in the end, 18 out of 19 of us agreed to this report the way it's written. Every one of us would find fault with any line, but as a whole it represents our best effort, and I think it gives you some food to work on.

As to the extended mandate, I know I can give my answer.

Ms. Judy Wasylycia-Leis: The summer?

Dr. Frank Chandler: I think we all have other jobs our employers would like to see us back home for. Thanks for the offer, but no thanks.

The Chair: I'm not sure she's in the position to offer the jobs, but that's all right.

Mr. Myers.

Mr. Lynn Myers (Waterloo—Wellington, Lib.): Thank you, Madam Chair. First of all, I want to thank the panel for an excellent report. I think it's really enlightening.

I want to go to the final paragraph of the executive summary on page 2. I thought you made an interesting point in your recommendation:

that, not unlike the principles underlying holistic medicine...the proposed new regulatory framework be considered in its entirety.

I wonder if you could expand on that. Does that mean we as a committee shouldn't or couldn't take parts of some of the best ideas out of this?

Dr. Frank Chandler: By the time we got through with it, we felt we'd tried to bring it together as a whole package. We were fearful it might be cherry-picked and some of the ripe cherries might get left behind. So our recommendation is that you look at it as a whole.

What you do with it is clearly in your hands, but we feel each of the issues is linked. In fact, one of the problems we had with our debates was trying to focus on each of the individual issues as we were going through it, when we knew the whole picture was surrounding it.

Mr. Lynn Myers: In the supplementary, you say it should be reviewed regularly. I wonder what you had in mind there. In a broader context, that's a good suggestion, no matter what we do.

Dr. Frank Chandler: Right. When we were looking at it—and we're dealing with an act now that's 40-odd years old—a lot of the things that were written in that act were probably very apropos for the time but totally out of context with today's society.

Obviously we know we can't hit everything right the first time through. So we felt, take an 80-20 kick at it, so to speak, do the best you can on the first round, and then review it and make sure it's working. Those parts that are working well, leave them there; those that aren't working so well, how should they be modified? We want to make this a sort of dynamic legislation, rather than something that gets stuck in the books forever.

Mr. Lynn Myers: That was a good point and a valid observation.

I want to go back as well to the issue of claims, and I think you correctly point out structure-function claims, risk-reduction claims, and treatment claims. I think you said in testimony, and certainly I'm seeing in the report, that there was genuinely vigorous debate on this issue and a minority and majority kind of position.

I wonder if you could give a further flavour to that debate and why you then ultimately came down on the side of voluntary. Was it an issue of money, or an issue of having to make people go through ropes and hassles unduly? What was the tenor of the final straw that broke the camel's back?

Dr. Frank Chandler: I probably did not give a clear enough explanation. The structure-function claims, the risk-reduction claims, the treatment claims, were agreed by the panel. There was no argument there.

Mr. Lynn Myers: I understand that.

Dr. Frank Chandler: It was when we got into no claims—

Mr. Lynn Myers: Exactly.

Dr. Frank Chandler: —that we had all the problems.

For the most part, people felt that it was desirable to have claims on the product, but there were those who felt there were valid reasons for having some products out there without claims, and that was the point where we had dissension. There were a number of people who felt “no claim, no product”.

A voice: There were two.

Dr. Frank Chandler: Two, yes.

Mr. Lynn Myers: But you go on as a panel to say there should be and must be an enforcement mechanism in place to protect against product displays or false or unsubstantiated claims. That's correct as well, right? You want that to be in place, that there not be unsubstantiated claims.

Dr. Frank Chandler: Yes. There's a difference between no claim and an unsubstantiated claim.

Mr. Lynn Myers: Right, thank you.

The Chair: Thank you very much.

We'll go to Mrs. Ur.

Mrs. Rose-Marie Ur (Lambton—Kent—Middlesex, Lib.): Yes, thank you, Madam Chair.

This question was basically asked and answered by Dr. Wu as to separate categories for various products. Would that be more difficult to implement if you had to set up that kind of structure?

Dr. Mary Wu: It may not have to be a separate structure, but when we make up the policy, we need to take these different paradigms of natural health products into consideration, especially, for example, homeopathic remedies, which usually are used as a single compound.

• 1650

Dr. William LaValley: Well, there's both.

Dr. Mary Wu: Okay; let's say “commonly” used as a single compound.

Those compounds are usually toxic compounds, used in an extremely diluted manner, to treat conditions or symptoms. So if you are going to evaluate the quality and safety of this product, establish a process to evaluate this product, and apply it to traditional Chinese herbal products, that won't be appropriate. In traditional Chinese herbal remedies, those are usually used in combinations—not only one herb, or two or three, but sometimes more than ten.

So when you establish a policy to evaluate the safety and the quality of the TCM herbal remedies, certainly you cannot use that one for homeopathic remedies. Therefore, it doesn't have to be a separate structure, but the policies can be different.

Mrs. Rose-Marie Ur: So would you be suggesting something like “western herbs”, “traditional medicine”, “vitamins and minerals”—divisions like that? Is that the way you would categorize them?

Mr. Mary Wu: It may not be every single type of natural health product, but at least for those major branches, such as TCM and the homeopathic remedies.

Mrs. Rose-Marie Ur: All right.

My next question is for you, Dr. Chandler. In your presentation—and maybe I misunderstood—you had stated it was a necessity to have “controlled professionals”. Is that more important than control of the product?

Dr. Frank Chandler: Probably not. Certainly if you don't have controlled products, then the professionals still don't know what they're dealing with. A lot of practitioners are practising in good faith, with good education, but if they're buying their products from unknown sources, or sources where they have no guarantees, then some of the products they're dealing with may not be of any benefit to their patients.

So I think the first step is definitely control of the products, and secondly, the regulation of the professions involved. Different herbs, different types of practices, and different levels of regulation should be there as well.

Mrs. Rose-Marie Ur: Dr. Wu.

Dr. Mary Wu: I think the regulation of practitioners is very important as well. Our mandate here, as it is at the federal level, is to look at the products. Practitioners are not a major mandate for this committee or for the panel, but it is a very important issue.

Yes, these products can be bottled up, and we can label them to provide consumers with information to make smart or wise choices for safe and quality products, but what about the service? The service cannot be bottled up, but certainly the quality of the service has to be taken into consideration when we're talking about protecting the public and providing good service to the public.

Right now, for example, in acupuncture, basically there are only two provinces that have acupuncture regulated. Most of the provinces do not have acupuncture regulated. Therefore, almost anybody with or without training can claim they are acupuncturists and can practise acupuncture.

As we know, in acupuncture, needles go into the body. This is a formal medical practice in China. People receive about five years of full-time medical school training to be a professional acupuncturist, whereas in Canada, people can take about one week of training and start to practise this medicine. What must the public think?

I have patients come to me saying, “Mary, my doctor thinks this might be helped by acupuncture, but who am I going to go to? There are so many people practising acupuncture.” They know my credentials—I'm on high-profile committees and so on at the federal level—and they trust me, but what about other people there?

So this is about practitioners, and also the training of the practitioners.

By the way, a typical problem at this moment is that people who get about three months of training in acupuncture are opening up schools to train acupuncturists. This issue has to be looked at. Otherwise, the public is not very well protected. We need to look into this issue.

The Chair: Thank you.

Dr. LaValley, do you want to comment on the same question?

Dr. William LaValley: Actually, I have a comment on three components that I want to highlight and that I think are important to address. I think it will be important for the committee to extract these out of the report.

• 1655

One is the fact that where we're making a distinction between conventional pharmaceuticals and natural health products, the Food and Drugs Act also takes into account devices. So we need to recognize that we're also talking about conventional medical devices under pharmaceuticals. Under natural health products, there would also be complementary health care devices. There is a very broad range of these devices, especially ones that are coming out of Europe that have very little context for conventional medical use and that are going to be more and more prominent in the market. So the suggestion would be—it was made through this panel—that they should be considered under natural health products.

As for the other two points I made, one is about the co-drafting of the regulations. It was a very strong conclusion of members of the panel that the drafting of the regulations be done in cooperation with some form of external body such as the type of body that was done here. Whether it's this particular body or not it is not particularly relevant, but that way, the issues can be worked out ahead of time rather than having the regulations drafted by the bureaucratic side of the equation and then go back and implement that with a whole lot of crises that would then be precipitated. This way, with strong actual co-drafting beforehand, before it goes back to the minister for approval, many of those issues can be handled ahead of time, and it would be much more cost-effective and much more efficient.

The third point has to do with import for personal use. I feel it's my particular determination to make sure there's representation of the so-called little guy, who is the patient or consumer who has a debilitating disease whereby they're desperately suffering or maybe their lives are in danger and they are getting access to products that are not available on the Canadian market. They are seeking to have these brought in for their own personal use without any redistribution or any other marketing purpose.

I think that issue is sacred and sacrosanct and we must very clearly recognize this as a freedom of choice issue. There are other companies, whether they're in the United States or Europe, who would not take the initiative because the Canadian market is too small for them or the hurdles are too large for them, such that they wouldn't be able to get their products in under these types of regulations.

Having said that, there is a whole range of abuse in this process of importation for personal use. This is specifically around some of the companies that would make mail order products available or the way that people import these products. This in fact abuses this privilege of importation for personal use.

So I think we really have to look at how to make appropriate regulations to make certain that the patient who wants to bring in products that are otherwise not available and not meeting these standards—but these products work for them—is not criminalized for doing so. We should also hold to the same standards other products that are brought in for redistribution or for other types of product lines, such as some of the multilevel marketing or network marketing programs. Let's not criminalize those who are already desperately suffering and who are getting access to what they need. Let's make the structure appropriate enough that it becomes a non-issue because we have these products available in Canada.

The Chair: Thank you very much.

Mr. McTeague.

Mr. Dan McTeague (Pickering—Ajax—Uxbridge, Lib.): Madam Chair, I wanted to compliment the panel not only for its work, but also for the thoroughness of its questions. They've been so thorough that I only have really one question.

It deals with the whole question of cost recovery. Were members of your panel at all concerned about the model of cost recovery and its potential impact in preventing some from this process of certification or testing versus others who may have deeper pockets?

Given your statement at one point, I believe that concerning a regulatory framework, you wanted to create something that was somewhat independent of the other procedures that take place within Health Canada. I guess my question is, how do you do that, and are there concerns?

Dr. Frank Chandler: This was certainly an issue in the minds of many on our panel, if not all: how do you fund an agency with members from those that have only a few products to those that are huge industries?

• 1700

One of the suggestions that came forward is a cap on the fee that any individual would pay as a percentage of their income or their revenue, in order to try to keep the field as level as possible so that the little fellow—if he meets all the GMPs and other standards—can still get his product on the market without undue penalty.

Mr. Dan McTeague: That was a discussion, but that's certainly not crystallized here.

Dr. Frank Chandler: No. There was a lot of discussion, but it didn't amount to recommendations.

Mr. Dan McTeague: In two or three years from now when I do have someone complaining I'll be able to remember this conversation.

Dr. Frank Chandler: Right.

Mr. Dan McTeague: Thank you, Mr. Chandler and everyone else.

The Chair: Thank you very much.

I have a couple of questions from the researchers. We need to have the answers so they can do their work.

In your report you haven't decided on a regulatory authority. You said it should be distinct and separate, but there was no consensus on the structure. On page 15 you've given three suggestions about where it might go. I think they seem to exclude food. Could we have some comments on how people feel about this federal body, a federal agency or a separate body within Health Canada or a separate unit within Therapeutic Products? Could we have some comments about what all of that means?

Dr. Frank Chandler: I'll comment and then I'll pass it over to André, who's champing at the bit here. I'm sure the others will want to comment too.

I think the underlying concern here is that however this gets structured, we must have people with the right expertise making the—and I know this isn't the term I should be using in my panel—“medical decision”, the appropriate therapeutic decision, on these products. How it's handled from there would depend a lot on the policies put in place to manage these products. But we need the real level of expertise making the decisions on how these products are managed.

André?

The Chair: How about a comment from someone who wants it to be a separate body?

Dr. LaValley?

[Translation]

Mr. André Gagnon: I will answer this question in French.

It wouldn't bother me if this were handled through the TPP. This is precisely what we have to check in the coming months. A little while ago, I gave the example of several products. For a number of products, we could request a DIN tomorrow morning, since we are currently still dealing with DINs. If four out of five applications were rejected, in spite of the expert opinion in our field, it would be clear that this could not be done in the context of the TPP. If, on the other hand, we see that the documentation provided is accepted, then there would be no problem.

The error that we are making is first of all to think of the structure and then decide that it absolutely has to be done outside the system, rather than testing the products.

To give you another example, if tomorrow my application for glucosamine sulfate, which has a proven effect on the joints, is accepted, there would not be a problem; however, if all of our requests were rejected, our reply would be different.

Therefore, I think that in the interim, we should test the system. Then we will have an immediate reply. This is my answer to your question.

[English]

The Chair: Dr. LaValley, you'll have to keep it brief.

Dr. William LaValley: The important requirement is that when a decision-making power is vested within some expert group, that the decision—unless there's some overwhelming and compelling reason with respect to the public's safety—not be overruled, that basically the integrity of understanding about these issues.... If we're going to access the greatest amount of expertise across the country, we need to put it in a framework that is in essence distinct. That could be an agency, which I think will probably be significantly more expensive, but within TPP it could be a separate directorate with this skeletal administrative body that is accessing the expertise.

Specifically with regard to the questions about cost recovery and how much it is going to cost, it will keep the costs down so that they will be competitive with those in the United States. In fact, if you look at what's going on in the United States, we could be exporters to the United States, because our products will meet the highest standards in all of North America and, arguably, the world.

The Chair: Mr. Volpe.

Mr. Joseph Volpe: I have a very brief question. Dr. Chandler, I think, talked about how practitioners would have to be more or less assured that there would be benefits to patients.

• 1705

Dr. Chandler, I'm not sure whether you said this, so I shouldn't attribute it to you, but the word “benefits” has been challenged by some of the people who have come before this committee, because there isn't the scientific evidence to show that the products we've been discussing for several months actually have any efficacy. So “benefits” and efficacy are interchangeable.

In response to an earlier question from me, you also didn't want to make the interchangeability between “reasonable” proof and “scientific” proof. I'm wondering now—and this is probably a question directed more to Dr. LaValley, who strikes me as a courageous individual—about the question of practitioners who are guided by provincial legislation to employ standards recognized under their regulatory bodies. How would any regulatory body that's going to approve some of these products keep in mind what Dr. LaValley must be going through every time he prescribes an item for which there is not scientific proof?

Dr. William LaValley: The particular mandate of this panel was to address the issues to guarantee consumer freedom of choice in health care and safety. That's the baseline and the foundation of what we're doing.

Safety issues are those around good manufacturing practices, appropriate quality control, and toxicity issues. Efficacy is an entirely different issue. People often confuse the two. Very frequently, safety and efficacy are used in the same phrase as if they're the same thing, and they are not.

Efficacy clearly has to do with, as you said, benefit or outcome, and we were not particularly and specifically mandated to address that. Having said that, we spent an inordinate amount of time addressing the issues of efficacy in claims and what would be required for validation. If we look at the notion of scientific evidence, the requirement to do double-blind, placebo-controlled trials is a very costly one, and that's supported only by the ability to have a patentable molecule at the end of it through which a significant profit can be made.

Without that type of framework in place, these natural health products, if they are safe—and again, we go back to the previous reference—are being used in a manner wherein clinical data are clearly accumulating about their benefits. The issue comes down to what the benefit/risk ratio is. Is there potential harm or likelihood of harm? Many of those issues can be mitigated through appropriate labelling, such as putting contraindications on the label, showing what products shouldn't be used in association with this, showing that this should not be used in pregnancy, etc. Many of those safety issues can be mitigated.

With respect to efficacy, however, we're left with this conundrum. What are we going to do and how are we going to find it? And really, the only reasonable, valid way to do it is to access those who have working knowledge, who have the expertise in the field across this broad base, and to access them where they are, in order to get a consensus amongst them.

Let us remember that conventional medicine right now, as much as it looks at focusing on evidence-based medicine, is a consensus-based process. Conventional medicine is based on the professional consensus of what works or what is considered to work. Sometimes it's correct and sometimes it's incorrect. It's a dynamic process and it uses the best of what we have available.

Let us take that idea and use it appropriately in this practice for these products we are using in order to make sure they are safe.

Mr. Joseph Volpe: Does Dr. Chandler agree with me that perhaps one of the reasons why there's been some dissension on the panel with somebody from his own background in pharmacy is that there's been disagreement about the ability to prove toxicity or the lack thereof on a scientific basis?

Dr. Frank Chandler: That was certainly part of the concern of the other individual, but when you're dealing with a lot of these products.... We have a tremendous body of literature that says these have been used for long periods of time in populations for specific uses, so you have a pretty good direction on efficacy from that viewpoint. It's not hard science, but if the same group of people is using the same herbs for the same reason for generations, hopefully it is being done for the right sorts of reasons.

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The toxicity is a concern to keep in mind. We know from traditional use that most of these plants are not acutely toxic. You can take a bolus dose of them and you're not going to keel over. We do not have a good handle on chronic toxicity, and this is something that we need to keep in mind. Again, if a lot of these medications are used properly, which is a problem in our current marketplace.... A lot of them are not used continuously, so if you use them for short bursts of time, the chronic toxicity is not a problem.

Unfortunately, people in North America think that if something is good, then more is better, and if it's good for a week, then taking it for a year will be even better. So you've got to get into that. You can put those bits of information on the label, like you do with OTCs today, but it still doesn't stop people from overdosing on aspirin. But I think you can make a lot of good labelling restrictions with information available so that the consumer can have an intelligent choice on something they have a reasonably good assurance will be reasonably safe and reasonably effective.

The Chair: Thank you, Dr. Chandler.

I think there are no more questions right now.

We'd like to thank you very much. We want to make sure that we can keep in touch with you if we have any questions while we're trying to come to some kind of consensus about our report. Thank you again for all the effort you put into it.

We will suspend for five minutes and then continue in camera.

[Editor's Note: Proceedings continue in camera]