Evidence of meeting #28 for Health in the 39th Parliament, 2nd Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was product.
A recording is available from Parliament.
Liberal
The Vice-Chair Liberal Lui Temelkovski
I call the meeting to order. You've all had an opportunity to have a look at the agenda. I understand there's a notice of motion from Monsieur Thibault.
Liberal
Robert Thibault Liberal West Nova, NS
Rather than presenting this motion and having an extended debate on it--we have a lot of witnesses today--we've had discussions amongst the parties, and I think there is agreement to have a one-session study on the question of the Insite program before the date on which funding ends. So the meeting would be in the month of May.
Conservative
Steven Fletcher Conservative Charleswood—St. James—Assiniboia, MB
Discussions have taken place. We'd be happy to facilitate that meeting with the minister before the end of May, provided the Liberals, the Bloc, and NDP don't defeat us on any confidence measures between now and then.
Conservative
Bloc
Christiane Gagnon Bloc Québec, QC
Mr. Chairman, had we debated the motion, I would have wanted us to go much further than merely discussing the issue of safe injection sites in Vancouver as part of an AIDS prevention strategy. I would also have wanted to discuss the book and the one million dollars wasted.
Why does Health Canada feel that it is irrelevant to publish a book on AIDS prevention that includes a foreword written by Mr. Couillard? I would like to shed some light on this issue.
Also, I would like us to discuss the lack of funding for HIV-AIDS and hepatitis C sufferers. The AIDs question should be expanded. Injection sites in Vancouver are not the only issue here.
Although we won't be hearing from any witnesses on this subject, it would have been an important topic. If we want to do some AIDS prevention, we need to do more than just talk about injection sites in Vancouver.
Liberal
The Vice-Chair Liberal Lui Temelkovski
Madame Gagnon, maybe I can encourage you to look at the motion and submit some friendly amendments for May 27.
Mr. Fletcher.
Conservative
Steven Fletcher Conservative Charleswood—St. James—Assiniboia, MB
I think we are fine with the Bloc raising those issues on May 27 or 29. I have had discussions with the Bloc health critic in this regard. If you would like to raise those issues with the minister at that time, that's fine. I don't know if we have to get into all the formalities of motions and that sort of thing.
Liberal
The Vice-Chair Liberal Lui Temelkovski
Moving right along, pursuant to Standing Order 108(2), we have a briefing on natural health products.
From the Department of Health, we have Philip Waddington, director general.
From the Direct Sellers Association of Canada, we have Ross Creber, president; and Mark Priemer, president of MMP Enterprises Ltd.
From L’Apothicaire-Consultant, we have Jean-Yves Dionne, pharmacist. Welcome.
From the University of Montreal, we have Pierre Haddad, professor, department of pharmacology.
From the Canadian Cosmetic, Toiletry and Fragrance Association, we have Darren Praznik, president and chief executive officer.
I understand that each organization has been asked to speak for five minutes. If there are going to be two speakers, we'll let you divide the pie of five minutes yourselves.
We'll start with Philip Waddington.
Philip Waddington Director General, Natural Health Products Directorate, Health Products and Food Branch, Department of Health
Thank you very much for the opportunity to come here to speak with you once again, Mr. Chair and members, about the natural health products regulations.
I believe everybody has the notes in front of you, so I won't read them word for word. I'll speak to the various points, and hopefully I'll be able to keep this within the five minutes we'll be held to.
As people know, the regulations came into force in 2004 for natural health products. We looked internationally at how products were regulated, we looked within Canada, we consulted, and we came up with regulations that we believe provided Canadians with what they asked for. They wanted products that were safe, effective, and of high quality.
When we met with people to look at how the regulations should unfold and what they should achieve, people basically said three things. They wanted to know that the products they were taking were safe--in other words, that they were not toxic and not contaminated. They wanted to know that what it says on the label is what is in the bottle. So if it says it is echinacea on the label, it has to be actually echinacea in the bottle, and if it says 100 milligrams, it should actually contain 100 milligrams. And they wanted to know that the product had a reasonable assurance that what it said it would do is what it would actually do.
That is what we believe we have achieved with these regulations.
If you look internationally, there are quite a number of different ways in which products are regulated. In some countries they are regulated as foods and in some countries they are regulated as drugs. In a few they are regulated with specific regulations, but the trend is toward having specific regulations for natural health products.
These regulations recognize that the products are generally of low risk. Under the framework we have, products are able to come to market with incredible evidence that the products are safe and effective in humans. This does not mean that every product has to have a clinical trial on that individual product, but it does mean there has to be evidence that the product is safe and effective in humans.
The standards of evidence that are applied in reviewing the products are proportional to the risk associated with them, and that's what we try to achieve with these regulations. For example, with traditional medicines, such as traditional Chinese medicine, some of these have had a long history of safe use, and we would turn to that safe use in evaluating the products. In other products we have done more modern or scientific research on them, and we've produced monographs, where people are able to look to the monograph that we have published on the web and make an application referencing that monograph for coming forward. So that is another way in which products can come forward.
In these monographs we outline what the appropriate dosages are, what claims are allowed within that dose for that product, and what the warnings are that should be applied to the product if it comes to market. For example, we now have a multi-vitamin, multi-mineral monograph, which covers the product that you would find under the product in that category. When an application is made for one of these products, we review the product application and respond with a licence or a refusal, depending upon how they've submitted it, within 60 days. We are getting back to these people who are making the applications in a rapid manner.
Under the natural health product regulations there are also a number of products that are now available in the Canadian marketplace that were not available before these regulations came into place. For example, licensed products can now be found on the market for melatonin, which has been used to help with sleep, for glucosamine sulfate, which is helpful with different types of joint pain, for 5-HTP, which is 5-hydroxytryptophan, and for L-lysine, which is used for cold sores. There are a number of products that people now have access to because of these regulations that they did not previously have access to.
Recognizing the risk profile of these products, in that they are relatively safe, we also apply our compliance and enforcement against these products, taking into account that risk profile. It is a risk-based approach as to how we're going to approach compliance and enforcement. We take action against those products that are of the highest concern, but we're not taking action against all products where there is any concern.
We do have to be aware that even though the products themselves, in general, are safe, we have to have some level of oversight. There are, for example, issues with respect to contamination or adulteration. There have been benzodiazepines found in natural sleep products, and these things can be addictive and habit forming, and they are products that we want to make sure we have oversight on. There are some companies that are repeat offenders in this regard, and we want to make sure we have oversight of them. With sildenafil and erectile dysfunction, there are a number of products that we find where there has been adulteration in that regard as well. So we want to make sure that while the original ingredients may be safe, we want to make sure that the entire product that has come to the market is safe.
Another example is with Kava. There has been an example where there were 14 accounts of liver failure associated with Kava, which is a herb that is used to help people calm down. The issue with Kava is that it was originally brought to market as a water-based extract. That's the way in which it was used traditionally. Over time that water-based extract was then moved to an alcohol-based extract. Later it became a pressurized acetone-based extract, and what gets drawn out of the herb is different under modern manufacturing conditions from what was originally drawn out of the herb when it was under its water-based extract. Simply because Kava may be safe, the way in which it comes to market has to be well looked at.
There are also increasing imports from China and India, and we want to make sure that the products--
Director General, Natural Health Products Directorate, Health Products and Food Branch, Department of Health
Wrap up?
Liberal
Director General, Natural Health Products Directorate, Health Products and Food Branch, Department of Health
I'll turn very briefly then to the performance within the natural health products directorate.
When I was here approximately two years ago, we had approved around 1,000 products and we had 100 site licences that had been processed by the directorate. Now we're at about 7,000 product licences and around 700 site licences. There isn't a backlog in the site licensing, and we're getting through the backlog in the product licensing.
It's estimated there were around 40,000 to 42,000 products when the regulations came in, in 2004. We received applications for just over half of those, and we've processed about half of those as well. We're now moving through this with a speed at which the number of licences for processing is greater than the applications coming in, and the backlog is in reduction.
The work that is under way, that we have put in place with respect to SOPs, with respect to batching products, grouping them together, with faster means of processing them, and electronic processing, have led us to a situation where we are confident that we'll be able to get through this backlog.
Thank you.
Liberal
The Vice-Chair Liberal Lui Temelkovski
Thank you very much.
We'll go to Mr. Ross Creber from the Direct Sellers Association of Canada.
Ross Creber President, Direct Sellers Association of Canada
Thank you, Mr. Chairman.
Mr. Chairman and honourable members, on behalf of the 45-member companies of the Direct Sellers Association and our 600,000 independent sales contractors across the country, I want to thank you for the opportunity to participate in this consultation.
Our independent businesspeople represent such well-known names as Avon, Mary Kay, Shaklee, NuSkin, and Quixtar, whose retail sales in 2007 approached $2 billion. Some of the products sold include those regulated as natural health products, and as such, the efficient and effective regulation of these products is of great importance to our industry.
I last appeared before this committee three years ago as it studied Bill C-420. At that time, I suggested that the bill was a product of the frustration of Canadians who wanted ready access to natural health products and of the companies who wanted to market those products to Canadian consumers.
Three years later, the frustration continues, with long delays in the approval process and a significant application backlog. However, there have been improvements, and NHPD has certainly made real efforts to increase efficiency in product approvals. These are laudable efforts, but the situation remains bleak.
So what has caused the backlog? We believe that Health Canada was never prepared for the number of applications that came in, and we believe that the directorate is optimistic to think it will have the backlog cleared by April of 2010. To date, the directorate has received product licence applications for approximately 27,000 products.
The reality is that the backlog has led many companies to delay submitting product licence applications or even to pull out of the marketplace altogether.
Let me give you a snapshot of our NHP experience. Our member companies have submitted 380 applications. Of these, 369 have been acknowledged and only 131 completed. However, “completed” does not mean approved; it means dealt with. In this case, 70 of the applications are now licensed, 34 have been refused, and 27 have been withdrawn. So far, only 18% of member applications have been approved and licensed.
Part of the backlog has to do with the standards of evidence required by NHPD. While compendial applications do increase the efficiency of the process, they only work for single-ingredient products, whereas the market is largely made up of multiple-ingredient products. And the evidence required is, in our opinion, excessive. The directorate's statistics confirm that their biggest challenge is dealing with non-compendial, non-traditional product licence applications for multi-ingredient products. Without improvements in this area, all available products will have the same materials, dosages, benefits, and wording on the labels. There will be no perceived difference from one company to the next.
I want to focus now on the thousands of product licence applications that have been rejected by the directorate. While the regulations provide for appeals, the actual process is, seemingly, known only to Health Canada. The directorate continues to promise that this policy will be released, but it has been almost four and a half years since the regulations took effect. Given the lack of transparency about the appeals process, it is no wonder that the industry is frustrated.
I want to offer you one more illustrative example of how deep the problems have become for the direct selling industry. The distribution channel of our industry, multi-level marketing, is regulated by the Competition Bureau under sections 55 and 55.1 of the Competition Act. Some provinces in Canada require a written opinion from the Competition Bureau on the marketing plans of a company before they will issue a licence to the company to operate in their respective province. The written opinion covers all of the provisions in the act pertaining to the operation of an MLM plan.
The bureau is now invoking its powers under other sections of the act to review all materials and product claims relating to product performance, and in order to provide the written opinion it is requesting similar evidence to that required for licensing of NHPs. This is new and troubling for an industry sector that is already regulated in a number of different areas, both federally and provincially. In our discussions with the bureau on this matter, we asked if they were aware that Health Canada regulated these products under similar criteria. The response was that, in their opinion, the process at Health Canada was not working and that they were fulfilling their mandate under the act.
Of course, it makes no sense whatsoever to have two agencies of government duplicating the work of each other. But the inadequacies of the process at the NHPD have driven our industry to this point, and as such, I can see no greater proof of a problem than this.
The DSA is encouraged by the recent activity on Canada's food and consumer safety action plan. The frustration of our industry is matched only by our willingness to work with the government and this committee to effect constructive changes to the Food and Drugs Act and the natural health product regulations.
Mr. Chairman, on behalf of the Direct Sellers Association and its members, I want to thank the Standing Committee on Health for the opportunity to participate in this consultation process.
Liberal
The Vice-Chair Liberal Lui Temelkovski
Thank you very much, Mr. Creber. You were right on time.
I would like to note that I omitted mentioning one of the groups with us today, the Option consommateurs, and Geneviève Reed and Anu Bose, who will also be presenting.
Now we will continue with Jean-Yves Dionne.
Bloc
Christiane Gagnon Bloc Québec, QC
Mr. Chairman, could you possibly ask the witnesses to speak more slowly. I'm having a hard time keeping up with the interpretation.
Jean-Yves Dionne Pharmacist, The Apothecary-Consultant
Good morning.
This time around, I will be making my presentation in French.
As a pharmacist, I believe the product licensing problem stems from a dispute surrounding the scientific data. There was an attempt made to impose a pharmaceutical model on products the use of which has nothing to do with the pharmacological model of one molecule—one receptor—one effect. We're talking here about extraordinarily complex products. A single plant can contain several active ingredients. When we're dealing with complex products—and Mr. Creber alluded to this—we're getting into a complex area where stakeholders tend to get completely confused by all the regulations.
Pharmaceutical products are patented products. The patent guarantees a protected market which makes return on investment possible and generates revenues to cover the cost of the research required by Health Canada. The problem with small companies—and in Canada, barring exception, companies that make natural products are small—is that they simply do not have the resources, whether it be to obtain scientific data or to keep pace in terms of financial and human resources. A number of small companies are thinking about closing their doors because of the cumbersome legislative requirements.
As I've already said, I'm a pharmacist and from my vantage point, I see both sides of the issue. When reviewing this whole question, it is very important to look beyond the people who are armed with university degrees, however knowledgeable and amazing they may be, and look to people with genuine ability in the area of product formulation. These people know why a given ingredient is used in a product, but they do not rely solely on lists. They also have practical skills that cannot be acquired in a classroom. They understand why a particular formula must contain a certain ingredient, or why another formula is totally harebrained, despite the accompanying scientific data.
One example I have for you is Red Bull, the leading energy drink on the market. To my knowledge, this product received the first ever NPN licence awarded in Canada. The pharmacological file on this product is extensive. However, is the safety of the product guaranteed? Has any follow-up been done with young people? Has anyone checked to see what happens when the product is combined with alcohol, or what the effects can be from an overdose or from chronic use of the product? No one has looked into this. I repeat, this is a well made, legitimate product, but it may not be as safe a product as it should be. You can read about this in my notes. I have made copies for everyone.
Do we need the same protective criteria for totally new, synthetic, biotechnology compounds as we do for organic echinacea tea formulated by the local herbalist? Of course, there will be a product monograph for the echinacea. However, when two plants, or native plants are combined and there is no product monograph, the poor herbalist will not have the resources to complete the file. The product will therefore be lost.
Summing up, I have to admit that the NHPD has done a very admirable job indeed. The creation of a third category is a first of its kind, or almost, in the world. This initiative deserves to be supported because in my estimation, natural products are neither drugs nor food substances. They fall into both categories.
Thank you.
Liberal
The Vice-Chair Liberal Lui Temelkovski
Merci, Monsieur Dionne.
Now we move on to the University of Montreal. We have Pierre Haddad.
Pierre Haddad Professor, Department of Pharmacology, University of Montreal
Good morning. I too will be making my presentation in French, if that's fine with you.
I would especially like to thank Christiane Gagnon for inviting me here, as well as her team and the clerk for helping me prepare my presentation. I would also like to extend my congratulations to Health Canada and to the NHPD in particular for trying to be rigorous from a scientific standpoint and at the same time for keeping an open mind when broaching the subject of natural health products. I agree with you that a separate category should be created for these products.
I will come back to the very laudable principles behind the regulations, which are now recognized as a model around the world. As Philip Waddington stated, these principles are based on freedom of choice and access to natural health products, as well as on the assurance of safe and high quality natural health products.
Today, I want to touch on three main points: safety, natural health product and drug interactions and the importance of research. I am the only witness here today from the world of academia. As you will see, many things are directly related to research.
The first thing I want to discuss is safety. Health Canada and the NHPD have issued many guiding principles, but there are four areas in particular that I want to touch on. The first relates to evidence. Health Canada has demonstrated its innovative spirit by including as evidence information stemming from medical and traditional knowledge. That is very laudable. Of course, this information is at the bottom of the evidence scale, but it is important to include it as health evidence.
According to the second guiding principle, all of the evidence must be weighed from every angle. This brings me to the third point, namely risk management. Basically, the Health Canada approach consists of assessing risk against benefits. I will give you an example of this later. Another guiding principle is that when in doubt, a person should abstain from using a product. If there is any risk, a person is better off not using a product.
I'd like to discuss the use of natural health products. In Canada and around the world, between 65% and 80% of the world's population use natural health products, compared to a much smaller proportion of people who must use synthetic drugs. This is an important statistic to remember.
From the standpoint of pharmacovigilance, natural health products are considered to be safe and available information shows that unwanted side effects are very rare. In the majority of cases, poor product quality is to blame. For example, the side effects could be caused by a bad plant, cutting or contaminants, as Mr. Waddington mentioned. The regulations governing sound manufacturing practices already address many of these problems because they call for the identity of the plant and the presence of contaminants to be verified.
Another thing to consider is that some available over-the-counter drugs such as acetaminophen also pose a real, serious risk. If a person ingests 10 to 20 times the recommended dosage, death could ensue, although this is not in fact noted anywhere on the label. The manufacturer relies on consumers.
I also think that the Natural Health Products Directorate is being somewhat alarmist about natural health products. This attitude is fueled to some degree health care professionals. It also stems from the lack of knowledge of health care professionals and from the lack of evidence on natural health products. Research in this area is therefore very important.
The principle whereby a person should abstain from using a product when in doubt takes precedence over all the others. I would say that when in doubt, a person should rely on human experience and on traditional medicine.
I wanted to touch on several other points, but I will move directly to drug interactions. Here again, there is a disconnect between the perceived risk and the real risk. People often use theoretical evidence to issue a warning against the danger of combining natural health products. However, if we consider the real evidence, we see that there is very little evidence that this is in fact the case. I strongly recommend that solid evaluation mechanisms be developed to weigh both risks and benefits.
Finally, I would like to talk about the importance of research. The NHPD is the only regulatory body with the funding to promote research and the mandate to promote research on natural health products. Unfortunately, its funding has been withdrawn. While the $1 million in funding was not a large sum of money for Canada, it still had an important effect in terms of leverage. I strongly urge you to restore this funding to promote research so that we are better equipped to assess both the risks and the benefits.
Thank you.
Liberal
The Vice-Chair Liberal Lui Temelkovski
Thank you very much, Professor Haddad.
Now we'll move on to Mr. Darren Praznik, the president and chief executive officer of the Canadian Cosmetic, Toiletry and Fragrance Association.