Health Committee on May 8th, 2008

[Darren Praznik, President and Chief Executive Officer, Canadian Cosmetic, Toiletry and Fragrance Association]

Thank you very much, Mr. Chair and honourable members of the committee.

On behalf of the CCTFA and our more than 160 member companies, which represent about a $5.4 billion industry in Canada, we'd like to thank you for the opportunity to speak to you on this very important particular matter. We have already forwarded copies of our brief, I understand, in both official languages to your office and staff, and we have distributed copies here as well.

First, let me just say that the member companies of our association continue to be and always have been supportive of Health Canada in its efforts to ensure the health of Canadian consumers. We know that Health Canada takes its job very seriously and strives to make decisions on the basis of sound science. We as an association also very much share the belief that regulation should be both effective in achieving its health outcomes and efficient as well in its operation. That's why as an association we support the amendments to the Food and Drugs Act that are being proposed by Bill C-51.

It is in the area of efficiency of operation, however, that we have our particular issues with the natural health products directorate. The first one I want to address, and it's been talked about already, is the backlog.

I very much appreciate the position Mr. Waddington is in. I know they work very hard at addressing that backlog. He keeps us well informed. We know as well that earlier this year we were looking actually at more applications coming in for non-compendial products than were being processed every day, so the backlog was expanding. We're glad to hear that you may have turned that corner.

But it really is unacceptable. Although they're trying very hard, they need to be sufficiently resourced and supported to be able to manage this particular backlog. We have member companies who don't even bother now bringing products in, if they have to wait a year or two to go through the process. We very much share the views that were expressed by the Direct Sellers Association of Canada.

Our recommendation to you today is that you don't want to get in their way to ensure that they're spending more time answering for what they're doing than addressing the backlog; that would be an unintended consequence of this committee's interest. But we think they need to be brought back on a regular basis to this committee to report on their progress and be able to get that backlog eliminated in as short a time as possible. That's enough said, I think, on that particular issue.

The other issue we would like to address is what we view as the unintended consequence of creating a third branch of regulation for what in essence are personal care products. When the NHP branch or division was set up under drugs, it was intended to address what were lower-risk products within the drug category.

All of the products that were in personal care products had traditionally been regulated under cosmetic regs or drug regs. When NHP's were created, the drug regs created a further subcategory. Our products were already regulated under drugs; they included antiperspirants, fluoridated toothpaste, anti-dandruff products, medicated skin care products, antiseptic skin cleansers, acne products, and primary sun screens, including makeup that had an SPF. These products were regulated under drug regs but were moved, because of their composition, under the NHP regs, which were intended really for a lower category of risk.

Because our products are generally very low-risk, I don't think enough attention was paid to the detail in similar regulatory regimes. The result is that we ended up with two very odd—I would argue unexplainable—and costly differences in regulation.

One, of course, was tamper-proof or tamper-evidence security packaging. I want to illustrate with the two products I have with me. I didn't bring them today because Phil and I thought it would be a hot debate and we needed extra antiperspirant, but these are antiperspirants. One is a drug; the other is a natural health product.

When the regs for the natural health products were set up, they followed pretty similarly the packaging requirements for drugs, except that they didn't include...the technical term, I guess is the “exclusion for topical products”. The result is, if you buy a drug antiperspirant in Canada, you do not need tamper-evidence packaging, but if you buy an antiperspirant that is a natural health product, with supposedly a lesser degree of risk, you need to put on a tamper-evident package.

I don't think anyone ever intended that to happen, but it was an unintended result of not matching the same level of regulation.

Manufacturers both in Canada and abroad who ship antiperspirants that are NHPs into Canada spend literally millions of dollars putting tamper-evident protection on your antiperspirant that adds really no value but that costs the companies and consumers millions of bucks.

Is that really what we're intending to do: have an unintended consequence of not making sure regulations match?

The second area that we just flagged is heavy-metal testing. Again, for NHPs, heavy-metal testing is required for our level of low-risk products. Nowhere in the world has that yet been required, but for drugs, supposedly a higher-risk heavy-metal testing is not required. Again, we have two sets of regulations applicable to drugs, which are supposedly higher-risk, and NHPs, which are supposedly lower-risk, and they don't match. The consequence to Canadian industry and Canadian consumers is having to pay a lot of extra money for, I would argue, no additional value. Again, there are unintended consequences and some oversight. We've been raising this issue for four years. I think there's some progress on addressing the antiperspirants issue, but we raise it and bring it to your attention again.

Thank you for your time, Mr. Chair.

[The Vice-Chair, Liberal, Lui Temelkovski]

Thank you very much, Mr. Praznik.

Now we have, from Option consommateurs, Geneviève Reed.

[Geneviève Reed, Head, Research and Representation Department, Option consommateurs]

Mr. Chairman, honourable vice-chairs and members of the committee, good day. I want to thank you for this opportunity to share our views on the main concerns that consumers have about natural health products. We will be focusing in particular today on licensing, evaluation and risk communication, consumer information and marketplace monitoring.

Established in 1983, Option consommateurs is a non-profit organization that has a mandate to promote and defend the interests of consumers and to ensure that they are respected. Our organization speaks out on regulations and on federal and Quebec policies. Our interest in the use of natural health products dates back to 2000 when we published an initial article on natural health product and drug interactions. We observed that consumers underestimated the risk of combining natural health products with drugs and that few pharmacists and doctors were in a position to give them information about possible interactions.

Through Health Canada's Population Health Fund, we have compiled for consumers a guide to natural health product and pharmaceutical interactions. We have produced two editions of this guide and over 500,000 copies have been distributed in Quebec alone. Since May 2006, we have also represented Canadian consumers on the advisory committee of Health Canada's Natural Health Products Directorate.

I would like to begin by focusing on product licensing. On April 15 last, we learned that a Quebec pharmaceutical company by the name of Neurochem, now known as Bellus Santé, was planning to market by year's end a product called Vivimind which is used to treat memory loss. In fact, Vivimind is the new name for Alzemed, a product used in the treatment of Alzheimer's which the US Food and Drug Administration refused to license. No doubt this will not be the only case of this kind in the coming years. Given that pharmaceuticals sales are declining sharply in wealthy countries, other pharmaceutical companies may decide to turn their attention to the natural health product market to finance research into new pharmaceuticals, particularly since the licensing of a natural health product in North America takes considerably less time than the licensing of a pharmaceutical.

However, how will pressure from the large pharmaceutical companies affect the natural health product licensing system?

We believe it is critically important to allocate additional resources to the risk assessment and communication process, particularly with regard to more vulnerable clients such as seniors and children. In 2005, the Canadian Paediatric Society expressed concern about the lack of scientific evidence as to the efficacy and safety of NHPs when used by children. We believe that issues such as deciding on the optimum dosage for young children as well as health product interaction with pediatric pharmaceuticals must be addressed.

Quite apart from the risks, consumers also need to know about the regulations governing NHPs and how they can file a complaint if a problem arises. Consumers must have access to clear information at the point of sale about the identification number of natural and homeopathic products. The consumer needs to be aware of the ingredients contained in these products.

Problems with the advertising of NHPs also top our list of concerns. The advertising of these products must be better regulated to avoid situations where Canadian consumers are misled. We also believe that the study of and research into natural health products should be part of the curriculum and ongoing training of doctors and pharmacists.

Finally, not only should NHPs be subject to rigorous trials prior to licensing, they should also be monitored after they go on the market.

The following guiding principles should apply when it comes to protecting consumers from natural health products: compliance with strict licensing rules, independent risk assessment and communication in clear and simple terms, regulation of advertising and marketplace monitoring.

Thank you for having us and for listening to our concerns. We will now be happy to answer your questions. Thank you.

[The Vice-Chair, Liberal, Lui Temelkovski]

Thank you very much, Madame Reed.

Now we will continue with questions and answers. Due to the heavy schedule today, there will be one round of questions of five minutes.

We'll start with Madam Kadis.

[Susan Kadis, Liberal, Thornhill, ON]

Thank you, Mr. Chair.

Welcome to all our guests.

I'm interested to know a few things today, very briefly. One would be your rate of refusal for applications. I know that many, it's been suggested, are voluntarily withdrawn. I'm interested to know how many are failing the approval process and why.

Also, I'd like to know where the data is going. We have recently been discussing post-market surveillance and adverse drug reactions and how industry has that information, as well as doctors, but not on a mandatory basis. Hospitals will have it shortly. Where is this information going so that we know whether there are adverse reactions to natural health products? Who is collecting the data?

I am a little bit concerned that research has been withdrawn from the directorate. I'm also interested to know about that. Why was that withdrawn? I would think it would be very important, considering that so many Canadians are using natural health products, probably more so, in particular, with an aging population. It's a very important area.

[Philip Waddington]

I think that one goes to me.

There were three parts, as I understand it, to your question.

The first was about where the data goes with respect to ADR--adverse drug reactions. The reports of serious and unexpected adverse drug reactions or adverse product reactions for natural health products go to the same database as the ones for drugs. The marketed health products directorate would collect that data and do the same thing they would do for drugs. They would look for a signal and whether there is something that should be a concern, and they would raise that up through the same process. So it's collected and processed in the same manner. Companies are required to submit the severe and unexpected adverse reactions but not the ones that are anticipated, such as, for example, flushing and things like that. So it's a similar process.

With respect to research, when we came into play we were funding research. A lot of it was seed funding that would go towards helping other applications for research down the road. It was considered successful by many. But it was anticipated to be a four-year program, and it has wound up. Now, there could be debate about what happens with that. We respond to the will of Canadians. When it was put in, it was a four-year program, and that has finished. So that's what happened there.

With respect to the refusals and the ones we've not licensed, we've licensed approximately, in total today, about 7,000. We've refused about 6,400. So it's close to 50-50, but it is just over to the positive side.

The reasons we refuse a product are varied. And I'll be honest; the reason we refuse them is usually not because the product is found to be toxic. That is why we use a risk-based compliance approach. If a product application comes to us and we're not aware of the toxicity, we don't take action against that product. It would only be if there was a toxicity or a concern about it in that regard. When an application is refused, the usual reason is that they have not provided the data we asked them to provide. For example, they may have a product that has three medicinal ingredients in it, and they will only provide the data to support one. We will write and ask them to provide data for the other two, and they'll come back and say, “How about this claim?” That happens all the time.

We're working with industry. I will say for sure that the quality of the applications we've been receiving over the last year has been better than it was for the applications we received previously. The training sessions and the dialogue with industry and working together to come up with an improved process is working. But we still have to process those applications that came in back when we first started the regulations. And that's why there's some delay.

The usual reason for refusing an application is because we have been unable to obtain the required data on the ingredients listed for the product.

[Susan Kadis, Liberal, Thornhill, ON]

Okay.

If I have a little more time, Mr. Chair, there's some reference to adding resources to clear out the backlog and move these along or facilitate that. What types of resources have you added in terms of applications? Is it personnel?

[Philip Waddington]

There were a couple of comments around resources. I would like to reiterate that a number of the members felt that we should be better resourced. I just want to put that back on the table.

What we've been doing with our resources internally is twofold. We've been trying to allocate people off more of the processing tasks and onto the ones where they actually have to review an application. So we're trying to be more efficient in our oversight.

The other thing we're spending a lot of time on, that we think is going to become beneficial for us, is electronic processing. What that does is twofold. It makes it less of a burden for industry, because they are able to fill things in electronically. I'd like to take a moment to talk about this.

We've recently piloted a process—and if you speak to any of the members who have been involved in this pilot, it's around 100 or 120 of them—where companies can download with Adobe, which is free to the applicant, and fill in an application to Health Canada, submit it through epost, and we can receive it on our desktop. This is the first time in the branch you're able to go from the desktop of the applicant to the desktop of the reviewer electronically.

I wish this meeting were happening two weeks from now, because next week we're going to be putting out the next version of our database, which references all the warnings and claims that are known around it, so people will be able to incorporate that into the applications that are coming forward. The week after that we're going to be putting out the version that will allow them to tie the compendial applications to that database.

The movement we have been putting towards having this electronically available and working with industry to make sure we reduce the requirements on them, but also, at the same time, to make sure that the products are safe and efficacious, is really coming to fruition right about now.

[The Vice-Chair, Liberal, Lui Temelkovski]

Thank you very much. I would encourage you to submit the information within two weeks to our clerk. That will be very helpful to us.

We'll move on to Madame Gagnon.

[Christiane Gagnon, Bloc, Québec, QC]

Thank you all for shedding some light on this very important issue in terms of the safety of natural health products.

I am concerned to see that several products on the market have not yet been assigned a number by the Natural Health Products Directorate.

Mr. Waddington, you analyse these products when a licensing application is made. It would appear that the level of risk is not the same for all products. Do you prescreen the applications, or do you review them as they come in? How do you proceed?

[Philip Waddington]

We receive information around the risk of the product from a number of situations. When an application is made to us, we have a list of the ingredients. There are also products for which, unfortunately, applications have not been made, so those would be found in the marketplace. We hear about them through competitors, usually, who will say, “There's a product on the market that contains an ingredient about which I'm concerned.” Those come to us as well.

When we review them, we look at them on a case-by-case basis, but at the same time, to improve our efficiencies, we batch them together. Using the example of glucosamine sulfate, we will gather those applications together and process them as a group to try to move it ahead more quickly. So we do both things. We look at them individually, we screen them when they come in, we look to the marketplace for what is available and what may be of concern out there, and then we group them together and process them as a unit to try to gather as much efficiency into that evaluation as we can.

[Christiane Gagnon, Bloc, Québec, QC]

Several witnesses brought up the subject of labelling. It seems that quite often, consumers are not given enough information about the effects of taking a drug in combination with a natural health product. For example, taking garlic and ginkgo along with a drug like Coumadin can produce some side effects that can adversely affect people's health.

Do we need to be much more proactive and adopt regulations governing the labelling of natural health products?

Other witnesses besides the Health Canada officials can answer this question.

[Jean-Yves Dionne]

I believe we're already seeing such warnings on product labels. For example, the label on a product containing ginkgo biloba will warn users not to take this product with an anticoagulant or a drug. Labels already contain warnings. Of course, this is not true of all product labels. Last year, there was a case of St. John's-wort interacting with a drug and causing a pregnancy. Health Canada and the industry are still feeling their way on this. However, the warnings are going out on product labels.

[Geneviève Reed]

Labelling is very important, but consumers also need to check with their practitioner, doctor or pharmacist. Consumers have trouble admitting that they are taking a natural health product along with their drugs, whereas this is a very important consideration.

[Pierre Haddad]

It is also important to weigh the evidence. In many cases, the analyses do not reveal as high a level of risk as anticipated. With respect to ginkgo, meta-analyses, that is an analysis of all information contained in literature, did not result in a finding of a clear association. One of the criticisms I had about the guide had to do with the small image of a microscope appearing alongside very theoretical or in vitro trials. So then, it is important to proceed with caution when passing messages along to consumers.

[Geneviève Reed]

I simply want to point out that this image was removed from the second edition.

[Christiane Gagnon, Bloc, Québec, QC]

Like many other people, I too use natural health products. These are viewed as a miracle cure for a number of health problems. Some believe that if they use these products, they will not have to see their doctors.

The impression we have is that people are not taking the warnings about natural health products seriously. Yet, they should be taken seriously. What can we do to make people understand this?

[Pierre Haddad]

As the representative of Option consommateurs said, education is the key. It's all well and good to tell people to check with their doctor, but if the doctor is not properly informed, then what is the point? Pharmacists, on the other hand, are slightly better informed. It is also time to debunk the myth that because a product is natural, it is harmless and at the same time, better for you.

It would be important to point out that natural health products help a great deal to prevent illness. People take these products to stay healthy, which is not the case with pharmaceuticals. What people are in fact doing is trying to stay healthy and not get sick.

[The Vice-Chair, Liberal, Lui Temelkovski]

Thank you.

Madam Charlton, welcome to the committee.

[Chris Charlton, NDP, Hamilton Mountain, ON]

Thank you, Chair.

I appreciate the submissions you made here today. It's clear that there's a real tension between effective regulation and efficient regulation. I also recognize that we're talking about these issues at a particular point in time.

Bill C-51 is just around the corner. None of you has mentioned it today. I know that you're probably going to be back here chatting about it some more. I wonder if I could lead you there now, though, in light of some of the concerns you've been raising.

I've heard from a lot of people in my community and across the country who are worried about the impact of Bill C-51 on natural health products. In that bill, it seems to me that what we're doing—

[The Vice-Chair, Liberal, Lui Temelkovski]

We've had discussions about that, and we'd prefer not to ask questions on Bill C-51.

[Chris Charlton, NDP, Hamilton Mountain, ON]

So we'll just pretend that we don't even know about it?

[The Vice-Chair, Liberal, Lui Temelkovski]

We will have subsequent meetings devoted to it—that's the only reason.

[Chris Charlton, NDP, Hamilton Mountain, ON]

Fair enough. I'll ask the same questions in a different way, then. I'll ask it in a more open-ended way.

Hypothetically, if there were some regulatory changes coming, what improvements would each of you be looking for in the regulatory environment?

[Mark Priemer, President, MMP Enterprises Ltd., Direct Sellers Association of Canada]

Working on behalf of many of the client companies and members of the Direct Sellers Association, we've been involved in submitting many applications. One of the things we complain about most frequently in our internal chats is that the regulations now seem to be a bit of a moving target.

We appreciate that regulation must be in place. We support the notion of safety above all other things. But with respect to proving efficacy, we have often found that matching the scientific literature to the products and the product licence application has been exceptionally difficult. In many cases, it is virtually impossible. We are hoping that there will be some measure incorporated to permit either extrapolation from the scientific literature or interpolation within the scientific literature. This would ease our path.

I said that the regulations sometimes seem to be a moving target. We have submitted perhaps more than 100 submissions for vitamins and mineral supplements, yet we frequently find new things appearing in information request notices. We're looking for the opportunity to learn from experience, which sometimes is not possible. Three or four years into the process, just when we thought we'd started to master it, we find we are still facing things for the first time.