Standing Committee on Health
Comité permanent de la santé
EVIDENCE number 11,
UNEDITED COPY – COPIE NON ÉDITÉE
Thursday April 22, 2004 – le jeudi 22 avril 2004
The Chair (Ms. Bonnie Brown (Oakville, Lib.)): Good morning, ladies and gentlemen.
It's my pleasure to call this meeting of the Standing Committee on Health to order. Pursuant to the Order of Reference of Monday, February 2, 2004, Bill C-420, an Act to amend the Food and Drugs Act is before us.
I now call clause 1.
(On Clause 1)
The Chair: It's also my pleasure to welcome back to the heath committee one of our former members, Jim Lunney, this is his private members' bill, and we'll invite him to describe its contents to us.
Mr. James Lunney (Nanaimo—Alberni): Madam Chair, thank you very much. It's a pleasure to be here this morning. It is a little bit disappointing that there are other matters happening on the Hill here, and that our representation is small this morning. Hopefully more members will be joining us.
This subject of Bill C-420 that's before committee today is certainly of interest to me, since I was the sponsor of the bill, but I would suggest that it's important to millions of Canadians, and it has to do with the regulation of natural health products. So for some members who haven't been present when the discussions happened in the House, or perhaps weren't focused on it, a quick review.
Bill C-420 has to do with the way natural health products are regulated. It's a very concise bill. It's basically a one-page bill, and it would simply change the definition of food and drugs. It would open the definition of a drug and say “excluding food”, and then it would open the definition food, and say “including dietary supplements, herbs, and other natural health products” as food, so they cannot be regulated as drugs. Currently they're regulated as a subclass of drugs, and that has resulted in a lot of problems, frankly.
There's a document in French and English which I hope has been circulated by the clerk. It's simply a review of the issue that was published in a magazine called Vitality which circulates in Toronto, some 50,000 circulated that I was asked to write, and it's a brief review of the issues. It's about five pages, and it's available in both French and English. The issues that frame the argument are outlined in that document. I hope all members have it that they can review, but basically this controversy goes back quite a number of years, Madam Chair, to around 1997, 1996 to 1997, then Health Minister David Dingwall, there was a move to bring all natural health products under a drug-style regulatory regime.
There was a huge public outcry at that time. I understand nearly a million people corresponded with government about the regulation of natural health products, vitamins, minerals, and herbs as drugs. The process was halted at that time, and the health committee of the day was asked to looked into the issue. A huge consultation ensued, a very good consultation under the chairmanship of then chair Joe Volpe. The committee reported in 1998, A New Vision, Natural Health Products, and some of you have that report before you.
Some 53 recommendations came out of the report, and then a transition team was developed, some 17 experts to bring a new office of natural health products into being, and you'll be hearing from officials as to what has transpired. The transition team made reference to these clauses that my bill would like to amend, clause 3.1, and 3.2. These clauses, to make the issue simple, clauses 3.1 and 3.2 basically state that it's illegal to advertise or label that a vitamin, mineral, or herb, or a natural product will influence a whole schedule of diseases, and that schedule, Madam Chair, is called Schedule A, and on Schedule A are diseases like heart disease, diabetes, cancer, a whole range of issues, all the way down to some rather obscure things, but about 40 ailments that you're not allowed to either label or advertise.
The issue goes well beyond labelling and advertising, because it seems the way it's been interpreted, and applied, it means that as soon as a health claim is made that it then triggers a three/one violation, and the product is considered making a drug-style claim, and therefore should be reviewed as a drug and go through a drug-style regulation.
The transition team, if I can quote from the report on page 42, picking up on the recommendation from the health committee said that clauses 3.1 and 3.2 and Schedule A of the Food and Drugs Act are no longer relevant. These clauses go back to about 1934, Madam Chair, and they've been tinkered with a little bit over the years, but the conclusion of the committee, if I may go on, says that they do not serve any purpose that cannot be accomplished by other sections of the legislation or regulations. And furthermore, they go on to say that the weight of modern scientific evidence confirms the mitigation and prevention of many diseases and disorders listed in Schedule A through the judicious use of NHPs. Their conclusion--it's time the legislation, and regulations reflect the prevailing science.
Now that's what the committee recommended. The minister accepted the committee's report and the transition team report and Canadians were led to believe that those clauses would be removed and that a third category would be created, not food, not drugs but in the middle, natural health products to regulate vitamins and minerals and herbs and things that come out of nature that are basically low-cost, non-patentable items that promote health.
Unfortunately the government chose to ignore those regulations and instead bring in something quite different. That is to bring in natural health products and a whole new office of natural health products, which has now become the Natural Health Products Directorate-- I'm sure we'll be hearing from Phil Waddington, the Director of that department shortly--that has come out of that effort.
This is placed squarely as a sub-class of drugs and there is no third category, it is a sub-class of drugs for purpose of regulation, natural health products are considered drugs. Out of that has come some real problems that persist today. I want to just briefly highlight what that means.
Scientists told us in the last number of years as the transition team correctly noted, that vitamins and minerals are vital to our health. Any of us who are reading the papers recently are aware of the...almost daily reports. A few weeks ago it was vitamin D and multiple sclerosis, 400 international units of vitamin D having a marked effect on multiple sclerosis. So you know there's a new appreciation for how important vitamins and minerals are. Unfortunately it's still illegal to tell Canadians that directly.
Some of the issues, I'd just like to raise a few of these by way of commentary. One would be, one of our major killer for members of the committee, we're all aware that heart disease is number one killer in this country. I find it rather bizarre myself and I think many Canadians would that even through there's some 2,500 articles in the medical literature about the importance of a simple vitamin supplement called "folic acid".
Now folic acid is what most members, certainly the ladies would all be aware, is a vitamin that women take when they're pregnant to avoid neural tube defects, some 400 micrograms, less than half a milligram they recommend, that's less than half a penny a day in a vitamin supplement but it turns out that folic acid is recognized today as one of the most important defences against heart disease and stroke.
It seems bizarre to me that Health Canada, along with Heart and Stroke Foundation and the Canadian Cardio-Vascular Society would advertise this, a two-page document here, this is out of the Canadian Journal of Cardiology July 2001. Unfortunately I don't have it in both languages to table but I'll just make reference to it. In this article they document that in the past 10 years there's been substantial epidemiological evidence for an association between homosistine and the risk of developing heart attacks, strokes and thrombosis.
They go in to say while folate therapy alone, that's folic acid alone, that's less than a penny a day is sufficient to correct, elevated plasma homosistine levels in most patients. They go on to say that supplementation have been proven to be effective in improving endothelio function and possibly causing the regression of corroded plaques.
Now so what I'm saying by quoting this is, we know understand about chemistry, that blood vessels get damaged when you don't have enough folic acid, you get a build up of this substance called homosistine, it damages the vessels and then cholesterol gets deposited in damaged vessels, leads to hardening the arteries.
Now it seems to me that it's something Canadians would want to know about. 2,500 Madam Speaker and it goes beyond heart disease and yet Health Canada will advertise the Journal of Cardiology but it's illegal to actually have direct...to let Canadians know directly, that something as simple as that. I would think everyone in this room should be taking a folic acid supplement, I had mine this morning and I hope you all did as well.
Now might be taken in conjunction with other vitamins but I could tell you Madam Chair, that I picked up a bottle of folic acid, not that I recommend people buy it there but at Costco for $2.99, enough folic acid to last the year, 365 tablets, that would help the average Canadian lower their homosistine.
Now researchers at University of British Columbia were saying this years ago. Why are we testing for cholesterol, which has a low correlation with actually developing heart disease, when we know that something like homosistine which has a correlation with developing serious heart disease, we're routinely not recommending and it's so easily corrected with a simple vitamin supplement.
So we now understand the biochemistry behind this, and frankly, there are some concerns about the way this is being regulated.
I want to give a couple of other illustrations. One of them involves a vitamin company in my own riding, about the way this is--well, not in my riding, it's on Vancouver Island--Biomedica, they produce product that has been very effective in helping people with arthritis. I know people here on the Hill who are taking what's called “Recovery medicine”. It's a simple vitamin and mineral compound. They recently won international recognition in the horse industry for helping horses with tendon and arthritis problems.
Interestingly enough, they also did work with dancers in Denmark, with ballet dancers, and they found that dancers found they had phenomenal recovery taking these products. It's illegal to tell people that Recovery could help them with their arthritis. It's relatively cheap. It's non-patentable. It's produced by a Canadian company. It's internationally recognized. Guess what? People would say horses are different from humans, but frankly, we do a lot of animal research. Animals are made out of the same things we are, Madam Chair.
Unfortunately, right now, Health Canada is trying to suppress Biomedica and making it difficult for them to market their product or even to continue to exist because a health claim is being made for their product. There are files on this and other products.
Another one I wish to mention to committee is a product called “Empower Plus”. This was important because many of the members here will remember a few months ago, we had a bunch of ladies here with red umbrellas. These are people who were taking a natural health product. It's called Empower Plus. It's a vitamin and mineral product that has helped people with bipolar disease.
Bipolar, I just have to use this as an example, Madam Chair, if you'll allow me, because it illustrates the problem in the ways these are being regulated. Alberta developed a product, a company in Alberta, that was helping people with bipolar. Word got out that this was actually helping people. It's a very serious disease. Manic depression, people are high and low. They're very productive people. When they're up, they're the most productive people on the planet. They hit lows that are so low, they're at high risk of suicide. This has been regulated with various drugs, or managed, traditionally.
However, when they were put on this vitamin product, people were actually doing extremely well, so well that the authorities in Alberta heard about it and they responded in what I'd say was a scientific manner. They started a study at the University of Alberta, a $544,000 study commissioned by the Alberta Science and Research Authority.
The early results were so effective and promising that they were published in four peer review journals. Under the leadership of Dr. Bonnie Kaplan at the University of Calgary; a researcher at Harvard, Dr. Charles Popper, picked it up as well; and another doctor, Dr. Miles Simmons, for example, all published their responses that they'd seen people taking this vitamin and mineral compound.
Yet, when Health Canada heard about this promising product, they moved to shut down the study. They shut down the study at the University of Alberta. Frankly, Madam Chair, I think this is something most Canadians would be rather astounded by, alarmed by, because whenever I talk to them about it, people can't believe that Health Canada would actually stand in the way of something that looks promising.
Furthermore, Health Canada sent in the RCMP to raid this little company in Raymond, Alberta, with RCMP officers in flak jackets to take their computers and to contact all these people taking this product and to advise them they needed to get back onto their drugs, their proper medical management with their drugs.
Now, one of these people, her name was Sabina. I'll just use her as an example, she lives here in Ontario, who came to the hill. Some of you might have talked to you. She was right here, in front of the Hill, with her red umbrella. Sabina had been 18 years on psychiatric drugs. She estimates she spent 10% of her 22 years of married life in hospital. That's costing us a lot of money.
She had been on the vitamins and minerals for a couple of years. Her liver function tests had improved, her liver, that was in great trouble because of the drugs she'd been taking all those years. Her diabetes had cleared up, taking the vitamins. She's working. She's paying taxes. She's volunteering.
Along comes Health Canada that wants to take away this product that has given her life back. She's not trying to kill herself or her husband, anymore. The husband, thank God, was a faithful man who stayed with her all those years, thinks he's got a new wife. Sabina would like to know why Health Canada would like to take this away from her. Frankly, so would I, Madam Chair.
The last word on that particular product I'd want to say, I don't have this in both languages, but they say “a picture says 1,000 words”. I have here pictures of research done by Dr. Brian Cole at the University of Lethbridge. He is a world-renowned neuroscientist. He doesn't work with humans, he works with rats.
The pictures I have here of rats who have had lobotomies. Some people would think that's a nasty thing to do to a rat, but Dr. Cole would cut out sections of their brains and then see what functions they could and couldn't do. Then he'd test various things to see if they'd improve function.
Dr. Cole put these rats with lobotomies on Empower Plus. Not only did they recover their function, amazingly, their brains actually regrouped. I have pictures here. Perhaps members would like to see them. There are only a few of you here. You'd be glad to look at these pictures. A picture says 1,000 words.
This is a world renowned neuroscientist. Frankly, Madam Chair, there's something wrong with this picture when we continue to regulate natural health products or try to protect Canadians from things that are good for them. I think Canadians would agree that maybe Health Canada is off-track on this and it needs to be fixed.
When these issues were discussed before the House I know members had a lot of interest in this file. I appreciate the support of our colleagues on our sides of the House. I was very pleased that the members agreed to send the matter here to health committee to be discussed. The vote was 124 to 85 with a number of government members supporting the bill coming to committee. Unfortunately we all know the time is short. We had to fight for even our room today. The time is short legislatively, but I would hope we can take the steps that are necessary.
What my Bill C-420 would do, frankly, is implement the promise the government made in accepting the transition team report. It would make the changes to change these antiquated clauses that continue to obstruct the delivery of effective natural health products. The list goes on, I've chosen a couple of simple ones that are easy to defend scientifically, folic acid and the Empower Plus because there's so much information available on it to illustrate the problems. But believe me, it's far broader than that. It applies to something like Chromium Picolinate for diabetes and we can go on for some time.
I know the members may have questions. I'd just like to suggest on the record for members and for this committee that this is an issue that needs to be addressed in order to address health care that works in Canada. I think that Canadians want to have confidence that Health Canada has at its heart building healthy Canadians and doing whatever is necessary to help see Canadians build healthy bodies and become low consumers of health services.
I'll just put this on the record. Frankly, I was in discussion with officials and I was asked this question about the bipolar, for example, it raises the question whether bipolar should be something that should be self-treated. I thought about that question for awhile and really, it disturbed me. Because it seems to me that it's a question only a bureaucrat would ask. Have we forgotten that the centre of the whole issue is really the patient If we're going to defend the letter of a regulation that goes back to 1934 over the interests of the patient?
If the patient could take a simple vitamin supplement and fix themselves and get off the waiting lists, Madam Chair. Surely, God knows, our doctors are busy enough, they're all overworked. The system is stretched to the breaking point and we all know the serious situation it's in. If they can help themselves by taking a simple vitamin supplement, surely we want to make that easier for them and not harder.
I'll rest my case at that point. I have lots more I could say, Madam Chair, but I hope that members will perhaps have questions they'd like to ask.
The Chair: Thank you, Mr. Lunney.
We'll begin the question and answer period with Mr. Merrifield.
Mr. Rob Merrifield (Yellowhead, CPC): I think the issue is something we've talked about and we've heard a lot about. This is something that was in House, was brought forward and had a lot of support. I think the reason it had the support was because we're making small changes, but have tremendous impact in the ability of individuals in Canada to be able to receive a product or their products of choice that aren't harming themselves; and that really boils down to the first question.
Maybe you would answer this, James. As far as the number of dollars that are actually spent by freedom of choice now in Canada for natural food products, do you have a number?
Mr. James Lunney: Yes.
Thank you, Mr. Merrifield, for that question.
Canadians right now are spending about $15 billion a year on pharmaceutical drugs. Research by the Fraser Institute, their review of the natural health products regulations published in 2001, their take on these regulations was that it's a cure worse than the disease. In that article published by the Fraser Institute, their studies show that Canadians are spending about $1.6 billion a year on natural health products, vitamins, minerals, herbs, because Canadians themselves believe that these products improve their health and many of them notice that when they take vitamin C they don't get colds as often, they take other antitoxin vitamins they don't get sick as often.
Mr. Rob Merrifield: All right.
You say $1.6 billion a year in natural food products compared to the $15 billion on pharmaceuticals, that's what you're saying. We just went through a study this last fall that showed that somewhere between, let's say conservatively 10,000 deaths a year caused because of adverse drug reactions in this country, that's probably very conservative and there's a study out there that'll verify that by...I think in May sometime it's going to be reported and be completed.
But can you tell me on the natural food products any reports of deaths because of the $1.6 billion that's spent on natural food products?
Mr. James Lunney:
It's hard to find any serious injuries caused by natural health products. It certainly is possible with some vitamins, if you really worked at it, to hurt yourself but these are so rare they're very hard to document.
Recently they took Kava Kava off the market-- which is something that people, particularly from Asia, take as a calming effect--because of a case where there apparently was some contamination--I think it was with arsenic--that had somehow got into it by the way they manufactured it.
But these things are so rare, they're hard to find, Rob. You see, natural products work through the body. Vitamin A, for example, if you took too much Vitamin A you could cause some damage but in most vitamin products, they don't use large quantities of Vitamin A, they use beta carotene and your body will take that--it's a precursor--and make as much as they want of it.
Can I make a point here, because you mentioned the research dollars they use here. The $1.6 billion compared to $16 billion spent on pharmaceutical drugs. Do you know, the other thing with the regulations here, the new office of Natural Health Products are going to commit $1 million to research on natural health products but we spend nearly $1 billion federal dollars a year researching pharmaceutical issues, largely, and that's roughly 10:1 of what's spent on pharmaceuticals and yet we only have 1,000:1 on what we're willing to put into natural health products--$1 million.
And why is it, in the regulations, that you have to be an MD or a dentist in these new regulations in order to do research on natural health products? There is hardly any research being done by MDs and dentists on natural health products. It's all being done by university researchers with Ph.D.s in neurosciences and neurophysiology or biochemistry, by and large, so I just want to put that on the record as well. It's a real concern when people see that in the regulations.
Mr. Rob Merrifield: The other thing is, your change seems to be very simple. You're basically not changing the regulations, necessarily. You're just saying it should be a food rather than a drug. Is that what the essence of your motion is, or your change is?
Mr. James Lunney: Well, that's half of it, Rob, that the definitions would change but also it would gut these clauses--3.1, 3.2 and Schedule A of the Food and Drugs Act--which the transition team acknowledged no longer serve any useful purpose.
It's already, by the way, in other sections. I think in section 5 it's illegal to sell food that's dangerous, or to have misleading advertising in relation to food.
Mr. Rob Merrifield: So who would be opposed to the change?
Mr. James Lunney: I think that's a good question to ask the director who will come because it seems that Health Canada is determined to maintain these clauses and I think that Canadians themselves--
Mr. Rob Merrifield: Okay, let me ask the question in a different way. Whose life would be compromised by the change?
Mr. James Lunney: Oh, whose life would be compromised.
Mr. Rob Merrifield: Well, you're changing it from a drug to a food. I mean, are we compromising anything by making this change?
Mr. James Lunney: I don't see there's a risk to the public. I think Health Canada could take a different approach in the way they do this. We're not opposed to all the other regulations and good manufacturing practices and things that need to be done to make sure the product is in the product, but Health Canada could give advice as to the health claims that are out there on low-risk products.
For example, there is traditional use for Chinese products. For thousands of years we were not aware of harm. Buyer beware. We were not aware of harm. So there is very little risk to the public in this.
Mr. Rob Merrifield: Thank you.
The Chair: Ms. Grey.
Miss Deborah Grey (Edmonton North, CPC): Thanks, Bonnie.
Thank you, James, for this. This has gone around the block several times, to be sure.
I'm interested in the fact that you say the transition team gave a report along these lines and it was accepted, for all intents and purposes, and then nothing ever came of it. When you talk about Health Canada and the difference that's spent--$15 billion versus $1.6 billion on pharmaceutical drugs--who's benefiting by that? And we've had some discussions in here just since I've been part of the committee about the pharmaceutical industry and lobby. Surely to heaven they wouldn't be in cahoots?
Mr. James Lunney: That's a question that needs to be answered by somebody and I suppose those questions are being asked because if it isn't in the public interest, I guess there are a lot of people who'd like to know whose interests are really being served by the way we regulate these things.
Miss Deborah Grey: You've said that somebody had asked you, should people be responsible for their own diagnosis and treatment vis-à-vis Empower Plus. Your response here was, “That was a question that only a bureaucrat would ask”. I'd put it to you that that is a bit of a slam, maybe on the bureaucrats, but would it be something that only someone in the pharmaceutical industry would ask?
Mr. James Lunney: That's another thing, a speculation that I suppose is a fair one that people are asking. Whose interests, really, are being served?
I think Canadians would like to see a response from not only the Health Committee but from Health Canada that indicates it's the patient's interest which is really at the heart of this and we're not trying to protect people from bogeymen that don't have a substance in science, but we're trying to deliver to them things that would make them healthy.
I think we have a little work to do, frankly, in this House and with Health Canada with officials to actually win Canadians' confidence because while not everybody is aware of the benefits of natural health products, increasingly, more and more Canadians are and they're taking their vitamins in the morning. I hope everyone here did.
M. Barrette and I had a little discussion about that this morning, and I would encourage him to take more than orange juice but you know, more and more Canadians are taking vitamins and minerals to build healthy bodies and it seems that we need a shift in the emphasis on health, on building health, and reducing health needs through healthier people.
Miss Deborah Grey: Granted, and of course the baby-boom generation that's coming along is going to just absolutely swamp the system 10, 15 years down the road now, because we are all aging.
Someone on this committee, actually, a couple of weeks ago, said something about food supplement junk. I was rather surprised by that, because it sort of sent the signal to me that this was all weird and wacky, and it's all the leftovers from the hippie generation in the sixties that are participating in this--taking natural health products, supplements.
I don't think that's a bit true, but there's an attitude, I think, that we need to overcome, and so when I look at...again, I go back to this transition team that was set up through the directorate or the office of NHPs. If that is a wise responsible group, and government had the forethought, I suppose, to put that group together, and then not accept those recommendations, what could we do about it to put pressure on from all sides of the House to make sure this happens?
Mr. James Lunney: I think, frankly, the committee and the House, as members of Parliament, we really do have the power to fix this. If we simply implemented the provisions of the bill, things would have to change, because the obstruction that's going on right now--for example, for the people across the nation who have called me, who have had their product obstructed, and many of them feel their lives are at risk.
We have a couple of people in the room right now--they're not scheduled as witnesses--who have had their lives transformed from taking this product and seen their futures, I mean their lives come back through taking this EMPower Plus product I was talking about. Furthermore, people like Ron Lajeunesse, who is the head of the mental health division, Canadian Mental Health Association in Alberta, who is aware of at least 25 families that have had people revolutionized through taking that particular vitamin product, and yet here is Health Canada moving to obstruct delivery of the product. He is outraged.
I know that there are people in the industry, and the standard medical response to this--if you excuse me saying it that way--is, “That's anecdotal evidence”, what Richard or Philippe would say; “That's anecdotal”, what Sabina would say; what Ron Lajeunesse has observed. But I have to say it on the record, you know the foundation of all true science is observation. I studied science. That's one of the first things we learn--science is the study of that which is observable and reproducible.
I think there's a great risk if we take all of what people want to call “observations” and say, “That's anecdotal, therefore it's somehow unworthy of consideration”. A real scientist would say, “Whoa, let's take a look that”, because science itself is not threatened by looking at new evidence. It simply wants to examine it from all angles.
I would suggest that somehow science is being pushed aside, and perhaps it's continuing to be pushed aside, because we're undermining the very foundation of science by ignoring observations. If it's low-cost non-patentable, it's wrong to regulate these things as drugs with high costs to regulate.
Miss Deborah Grey: Yes, but there has to be a motivation behind that. Why would Health Canada be so concerned about that? If you're looking at short-term versus long-term costs, or whatever, if the pharmaceutical industry is making piles of cash....
I'm going to put this on the record here, that after 15 years of being a member of Parliament, I have been bribed once, once in my office. That was by a pharmaceutical company. I am not criticizing them all, but of all the years that I have been here, I got an actual physical bribe from one of them, and I drummed them out of my office so fast, they're darn lucky they didn't need some pharmaceutical drugs after it was all over. This is despicable. I know that there's good people and lousy people in every field, but it's just--
Hon. Don Boudria (Glengarry—Prescott—Russell, Lib.): If I may, Madam Chair--
Miss Deborah Grey: No, Don, this is a serious issue.
Hon. Don Boudria: It may very well be.
A point of order. If someone has an accusation of a criminal nature to be made, it shouldn't be made in committee against an industry. It should be made on the floor of the House of Commons. The House can deal with that, or it should be referred to the police. But an industry is being maligned--
Miss Deborah Grey: No, it's not, Don.
Hon. Don Boudria: Of course it is. It's a criminal accusation that is being made right now in this committee, and it's on the record of this committee right now. So either it stands up, or it's expunged from the record. That's a criminal act that's alleged to have been made right now. I don't think it's right for us to use a venue of a committee to make a criminal accusation. It's an offence against the Criminal Code. I know enough about it to know that's what it is.
Miss Deborah Grey: You know everything about it, evidently. I'm just making an anecdotal comment that we have some concerns here--
Hon. Don Boudria: Anecdotal criminal charges.
Miss Deborah Grey: pharmaceutical drugs here, prescription drugs.
So, forgive me, I'll expunge anything if it's making life difficult.
The Chair: So the clerk will note that Ms. Grey is willing to have those comments expunged from the record.
Miss Deborah Grey: Yes, I mean, I can't even remember who it was, because it was years ago, but I remember the incident and I remember the feeling I had and I just thought, “I don't want anything”. I did not malign the entire industry. That will stand up on the record of what I just said. I said there are good people and bad people in everything.
We just spent a whole lot of time and effort in this committee talking about prescription drugs. You yourself have made comments, and I know we have frustrations with this. I think if that kind of attitude is being held up here, to go against the actual transition team that made great recommendations and was in fact accepted by Health Canada, then, sorry. I think we'd better look at it pretty seriously.
The Chair: Thank you.
We'll go to Mr. Ménard now.
M. Réal Ménard (Hochelaga—Maisonneuve, BQ): Merci. Je vous rappelle, madame la présidente, que tous les députés jouissent de l'immunité parlementaire au comité, n'est-ce pas.
Je suis un peu surpris...
I'm going to speak in French, of course, because I am a romantic man, as you know.
Some hon. members: Oh, oh.
Mr. James Lunney: Yes.
M. Réal Ménard: Alors je suis un peu surpris de votre projet de loi, M. Lunney. Bien sûr au Bloc québécois, mon collègue Bernard Bigras et moi-même, mais davantage lui, avons suivi ce dossier. Nous avons voté pour le projet de loi de telle sorte qu'il puisse se retrouver ici au comité, mais nous ne serions pas disposés à l'adopter maintenant. Je veux que cela soit très clair. Il y a des amendements qui nous apparaissent devoir être apportés.
D'abord ce comité a déjà fait une étude de la question des produits naturels, il y a plusieurs années. C'était Mme Picard qui était notre représentante à ce moment-là. Ce que les témoins étaient venu nous dire, m'a-t-on dit et c'est quelque chose de vérifiable en lisant le rapport du comité, c'est qu'il ne fallait pas amender la Loi sur les aliments et les drogues pour inclure les produits de santé naturels dans la rubrique «aliments», mais créer une troisième catégorie. Pourquoi, quant à préparer un projet de loi d'initiative parlementaire, ne vous êtes-vous pas rendu à cette conclusion du rapport du Comité de la santé? Il apparaît que votre projet de loi ne va pas assez loin par rapport à ce que le comité avait lui-même recommandé, il y a de cela plusieurs années.
Donc ma première question est celle-ci. Pourquoi n'êtes-vous pas allé dans le sens d'une troisième catégorie? Cela aurait été beaucoup plus facile pour le Bloc québécois d'appuyer et de voter en faveur du projet de loi, même si le projet de loi a le mérite de remettre sur la table toute la question des produits de santé naturels. Voilà pour ma première question.
Mr. James Lunney: In the definition of “food and drugs”, for example it says:
|Food includes any article grown, manufactured, sold or represented for use as food or drink for human beings.|
And it's got chewing gum in here.
|Chewing gum and any ingredient that may be mixed with food for any purpose whatsoever ...|
We would be adding:
|, including dietary supplements, herbs and other natural health products.|
Even around my own caucus, people raised concerns about this “for any purpose whatsoever”. I guess that made sense to somebody back in 1934, but I think that language would have to be amended, to be clear.
I know what you're saying--I'll come back to your question--it's why did I not go back to creating a third category in the middle? Well, frankly, in consultation with people in the health food industry who are very concerned about this, they were looking at what the easiest way is of amending the existing situation. All the movement towards an office of natural health products that's been done, and the development of a new natural health products directorate now, what was the easiest way to amend it? Frankly, we came to the conclusion that the easiest way simply was to move it under the category of “food”. We had food, we had drugs.
These things are, frankly, because of their long history of use, and safe use, we felt it was a simpler exercise to come up with a one-page bill that would simply change the definitions, gut those obstructive clauses, and that this would be the simplest way to advance the issue. I'm sure it's not the only way, but we looked at that as the simplest way legislatively to move things in a direction that would advance health care for Canadians.
M. Réal Ménard: Je me rappelle, il y a peut-être deux ans, j'avais demandé à Santé Canada de nous donner une session de formation sur la question des produits de santé naturels. Si votre projet de loi était adopté par ce comité, et ultérieurement adopté par la Chambre, quelle serait votre compréhension des impacts qu'il aurait sur la question de l'étiquetage? Si on inclut les produits de santé naturels dans la catégorie des aliments, qu'est-ce que cela voudrait dire sur la question de l'étiquetage?
On m'avait expliqué qu'une des difficultés qui se posent c'est que sur le plan de l'étiquetage, on veut considérer les produits naturels avec l'obligation de donner une monographie très complète non seulement de leur composition mais de ce que cela pourrait vouloir dire aussi en termes d'interaction médicamenteuse ou lorsqu'ils sont consommés avec d'autres types de médicaments.
Alors, si on adopte ce projet de loi au comité et qu'on le renvoie à la Chambre, comment pensez-vous que l'on va traiter sur le plan de l'étiquetage les produits de santé naturels?
Mr. James Lunney: That's a very good question. It's certainly a very technical one, and I imagine one that would require some thought and discussion.
Many of the questions, and the way they are framed, complications of medications, interactions, and all of the possible uses, are simply items that even with a medical product, a drug, are impossible to get on simple label on a bottle, you just never get all that information on a bottle, and they can't with drugs, either. We started to talk about all the possible ramifications, and permutations, and combinations of possibility. It sounds exhaustive in what is being asked for by people who think that way. We have to realistically understand that there is only so much you can put on a label. Frankly, right now, with all due respect, Mr. Ménard, when you are trying to list a whole range of vitamins and minerals on a bottle... You see, I'm at that age where I already have to use glasses, I still think I can read, but frankly, I'm finding more and more that I can't read without these darn glasses. To read what's on a label, on a vitamin bottle when you have it already in both languages, there is only so much information you can get on a tablet bottle which, by nature of the products, they are not huge packages. I think there are issues about what information is practical to put on a bottle. It can't be exhaustive. Even the regulations, if you look at them, actually call for things that are impossible to deliver. Of course, with drugs, they put a package insert with a lot of fine print that if anyone ever reads it would give you most of the information, but that's not exhaustive either.
M. Réal Ménard: Par exemple, moi je consomme de l'échinacée. Je prends pour acquis que l'échinacée est un produit de santé naturel. Moi je prends de l'échinacée pour m'assurer que mon système ne soit pas affecté lorsque je sens que je pourrais avoir la grippe etc. Quelles sont les exigences de Santé Canada, à votre connaissance, pour qu'un produit de santé naturel se retrouve sur les tablettes? On ne demande pas de monographie clinique, mais qu'est-ce qu'on demande, à votre connaissance, à Santé Canada pour qu'un produit puisse être en vente libre et un produit de santé naturel? Prenons l'exemple de l'échinacée. Je pense que tout le monde sait ce qu'est l'échinacée, on en prend probablement tous. Quelles sont, selon vous, les exigences que Santé Canada demandent?
Mr. James Lunney: It is all being changed right now, with all due respect. We have a new office of natural health products with a whole range of regulations that have been gazetted just recently. I think it was June when Canada Gazette 2 listed the regulations which go into great detail on good manufacturing practices and labelling. I think there is a big change happening right now with the schedule of time for the industry to respond and make sure that those regulations are complied with.
I think it is of interest, for example, on some of these products like echanacia. I'm not sure specifically, but for some products the therapeutically beneficial ingredient may be in the flower itself, or it could be in the leap, or it could be in the root. I think there are some concerns that you have people producing products that may use the right plant, but the wrong part, if you understand what I'm saying. You may get something that says echanacia, but you have the wrong part of the plant in there, and the active ingredient, frankly, is being misrepresented.
No one is questioning the need for good manufacturing practices, that Health Canada and the new department ought to be doing office inspections, and product inspections to make sure what is on the label is in the product, and that the facilities are clean, and respectable, and so on. Those are all necessary things, and I think Canadians accept that, and understand that, and want that. Even the industry wants that. What they don't want is an arbitrary removal of effective products, especially the most effective ones. Acid amino acid helps with cognitive function. We should all be taking it, but, frankly, it's illegal to buy it in Canada because it is a simple amino acid, it's a building block, a protein, and it would help people with memory. All of us probably in the House here, could use a hit of that especially at this time of year.
Thank you, Mr. Ménard. Mr. Barrette.
M. Gilbert Barrette (Témiscamingue, Lib.): Merci, madame la présidente. Je suis encore jeune dans la Chambre des communes. Les produits naturels, question très générale, quel objectif est visé par ce projet de loi principalement?
Mr. James Lunney: Mr. Barrette, first of all, I appreciate that you consider yourself one of the young members in the House; I notice that got a few smiles from our colleagues. Some of us--we range in age around the table here--still think we're young. I don't like to call myself a new MP anymore, I say, I'm slightly used. Most of us around the table, we're slightly used anymore, but welcome to the club, Mr. Barrette, who came recently to the House in by-election.
Now, Mr. Barrette, the object of the bill is to make a simple amendment to the Food and Drugs Act that would correct something that was overlooked; a very, very important part of this report. It was a key part; it was a part that goes back to this antiquated clause; it goes back to something like 1934, as best we can determine from the records. It had been tinkered with a little bit in changing the schedule of diseases, but frankly, that clause, it seems, has been use in the wrong way. It seems that the clauses about labelling and advertising have been used to actually remove the most effective products as soon as a health claim is made. There's something about that that intrinsically doesn't seem right. The Canadians, when they take a product, based on scientific research that shows it would help them with the cognitive function, they're thinking, or it would help them with their blood sugar metabolism, and yet because it's a simple and it's a mineral or it's amino-acid, Health Canada moves to take it off the market.
The obstacle seems to be these clauses, 3.1 and 3.2 and schedule A in the Food and Drugs Act. Those are clauses that the transition team said they're antiquated; it's out of step with science and we need to remove them. But the response from Health Canada has not been to fulfill that, it has been to instead, do something else, and that is, to put it as a sub-class of drugs and maintain these clauses, and frankly, from the behaviour of the department to this day, just recently sending the RCMP in the Raymond, Alberta to shut down one of the most promising natural health products, it could be revolutionizing the treatment of people with mental illness around the world, is simply inconsistent with what Canadians would expect from Health Canada.
It seems to me the foundation for that are these antiquated clauses that the transition team and the committee who looked into this, and I give full marks to the committee that did the report, “A New Vision: Natural Health Products.” They came up with 53 recommendations, and then specifying out of that came the transition team, and Canadians were watching this process and believing that something was going to happen to allow an advance of the natural health products that they've come to trust, the ones that are listening and reading and taking products to help themselves.
They are very frustrated right now because they see something else happening that's saying, oh my gosh, we thought we were getting a third category that Mr. Ménard was addressing, but in fact, they're not getting a third category, they're getting a sub-class of drugs. That's not what they wanted. They want these things to be regulated as the low risk, low cost products that they are, not as the same type of regime that drugs have.
My hope would be that the committee would hear and respond to science, frankly, to make sure that science is not shut out from advancing simple things that would actually produce Canadians that are more resistant to disease, and therefore, they're not spending their time lining up in the hospitals and those darn waiting lists that we're all concerned about. If there's some way to build a healthier Canadian, who's not taking time off work because they're just not as sick as much, most Canadians would expect Health Canada would be interested in promoting that, and I think somehow we need to do that.
My take on this is that the easiest way to do it is to implement the changes that we're asking for in the bill. It's probably not the only way; there's room to consider amendments; there's a shortage of time, and I think that, frankly, with the terrible situation that our health system is in, we would be very well positioned, as a health committee and as a government if we took this issue, and said, look, we're going to do something to change the direction we're going, to help make these products more available, unless we're aware of harm. If we are aware of risk to people, and there's some documented cases, then let's look at protecting people from things that they need protection from, but to invent bogie men on a theoretical basis and take away products that show such promise, is simply not acceptable.
That is why I am appealing to the committee and why I put it before the House on behalf of people in the industry who are very concerned about the direction and hope to see a new direction come out of this, as was promised by the committee report that said, a new vision.
M. Gilbert Barrette: Vu que Santé Canada ne veut pas considérer certaines recommandations, quel est ou quels sont les arguments principaux pour ne pas mettre en application, ou être hésitant en tous cas à faire des changements?
Excuse me, Mr. Barrette, we actually have a witness from Health Canada who, I think, would be a better person to answer that question. When we finish with Mr. Lunney, we have a person from Health Canada who could answer that question, I think, more precisely.
I think we'll move now to Mr. Boudria.
Hon. Don Boudria: I'm in no particular rush.
J'aimerais revenir au point soulevé par M. Ménard sur l'étiquetage. Moi aussi, je ne dirai certainement pas que je suis ni jeune ni vieux au Parlement parce que les deux seraient un peu exagérés après près de 30 ans à une fonction ou à un lieu quelconque. Je dois dire que, comme membre du Comité de la santé c'est la première fois que je fais cela, seulement depuis quelques semaines. Donc notre témoin, notre collègue, lui qui est un professionnel dans le domaine de la santé, on aura bien sûr à lui demander d'être patient avec certaines d'entre nous. Premièrement je le félicite pour son initiative de rendre plus actif ce débat.
Je reviens au point qu'a soulevé M. Ménard tout à l'heure en ce qui concerne les exigences sur l'étiquetage à partir du moment où on appelle tout cela un aliment. Bien sûr, je ne suis pas, encore une fois, professionnel dans le domaine de la santé mais les inquiétudes sont sûrement... ce n'est pas seulement le consommateur qui lit les ingrédients, c'est sans doute souvent un médecin qui va dire: «Assurez-vous, cher monsieur ou madame une telle, que si vous prenez telle chose, de ne pas prendre tel produit car il a ces ingrédients à l'intérieur et cela pourrait avoir tel effet. On sait que telle chose est populaire dans notre région récemment parce que plusieurs personnes en prennent. Mais on ne peut pas faire cela avec ce que je vous prescris aujourd'hui.» Et des propositions semblables. Est-ce qu'il y a une inquiétude à ce niveau?
Mr. James Lunney: I'll just give you an example. Probably one of the ones that was objected to in the medical world is a simple thing called “chromium picolinate”. As a health-care practitioner years ago, I'm recommending this to my patients. We should all be taking a chromium supplement. I checked my vitamin that I'm taking here in Ottawa, which is different than the ones I take at home, and it has 100 micrograms of chromium HVP chelate in it.
The point is that any good vitamin product should have chromium in it because you need chromium in order to metabolize sugar. It works with the glucose tolerance factor.
It seems to me that one of the best things the industry has ever done for diabetics is give them the ability to monitor their own blood sugar. If they are taking a simple chromium supplement, which is quite inexpensive, Mr. Boudria, and they see that their blood sugar begins to become more stable, they simply adjust their own blood sugar, their insulin requirement. And that's a very good thing.
If we have a low-risk mineral that can help someone, I think the question should be.... We all know, Mr. Merrifield mentioned earlier, that there are very big concerns about what happens when people are on drugs, especially long term. We all acknowledge that pharmaceutical drugs can be life saving because they do act quickly. If you've had a bee sting, and your lungs are clogging up with bronchial constriction, you want that shot of adrenalin pretty quickly. It could save a life.
Natural products that are so low risk, by nature, are different. If there's a lower risk way of accomplishing something that helps to build a healthier Canadian, surely we ought to give people the lower risk thing and then restrict the thing that's of higher danger.
Hon. Don Boudria: My question was not mostly about that. I accept what you're saying, of course. It wasn't in that regard.
It was more about the labelling requirements which, if I heard Mr. Ménard correctly, would not be there under the categorization of a food unless we did something else at the same time to make this labelling a requirement.
Not only could the consumer know--because as you've said yourself, I believe, that information is sometimes useful to them, sometimes meaningless, and a lot of times not right anyway--but it is also there for, presumably, other health care professionals in case they're giving some other product which might react in an adverse way with that ingredient which is in there but not labelled if it isn't done in that particular way. That was more of the question I was asking.
Mr. James Lunney: Mr. Boudria, it is a good question. There isn't enough known about all of the ramifications in this realm, but I would raise the question: is that a good enough reason to make these products unavailable to people?
L'hon. Don Boudria: No, perhaps not unavailable, just to ensure that we do the other protective measures.
You see, I'm not coming at this being against the idea, not at all. I was raised in a family where we had what were probably aboriginal recipes that were given to us, I don't know how. but many French Canadians had learned some medicine, several generations ago, particularly rural Canada, probably from aboriginal citizens. We were told to boil a particular weed and that was good for a particular ailment. And I still see some of them at home. I recognize them as something my grandmother used to give me. I have no idea why it was good. Of course, I have no idea why prescription medication is good either, for that matter, except that it does work, and that's all I know.
I start off with the proposition that, if it's a natural product, it can't, by definition, be good. I was raised with the opposite proposition. My garlic pills that I take every day, and vitamins and so on, means that I'm not against that. I'm just looking at ensuring that we have categorization a little bit in the way that Mr. Ménard is approaching it: to ensure that consumers are protected. That's the initial proposition in my head.
Mr. James Lunney: Yes, and I get that. That's the objection that is raised, repeatedly: about protecting consumers. But, Don, on the other side of the issue, while we recognize the need to protect consumers, all risks have to be evaluated in terms of other risks. It's a very low-risk thing that we're asking here.
When you talk about pharmaceutical interactions, frankly, there isn't enough known about how drugs interact. It's a big concern with patients that I used to see come in. Of course, one of the first things, even as a natural health practitioner, I'd want to know what meds they're taking. And it's surprising, especially seniors, who would come in with a shoebox full of medications that they've had over many years. Many times the current doctor doesn't realize they still have that old thing around and if they think their kidneys are down one day, they start taking that old medication and the other one for their liver and another one for something else. So, frankly, there is too little known.
I had a patient not long ago, before I ran for office, who actually had graduated as a pharmaceutical graduate, had done his thesis, I guess it was graduate thesis on drug interactions, and had actually tracked this on which drugs really shouldn't be given together. This poor man was really frustrated that he'd done this great work and it had been acknowledged work. He was sure somebody would snap it up and publish it and distribute it widely, but he couldn't find anybody who would publish it. Go figure.
Anyway, Don, if I may comment on the last remark you made there about natural remedies that are coming out, this is a big issue in the Province of Quebec, where, I believe, the les produits de santé naturels are consumed even wider than they are in the rest of Canada.
Many of the great remedies come out of non-agricultural land. They come out of the bush. And if we remember back to something that caused a big stir 60 years ago, something called Essiac, a nurse name Rene Caisse, who got this aboriginal remedy for cancer in the day. Essiac was her name spelled backwards, but it was basically an aboriginal remedy of slippery elm bark and powdered sheep sorel and burdock root and stuff that was out of the bush, about five herbs.
The point in that is that many of these great things come out of non-agricultural land. We've been farming the same soil for years and year and years. Each crop will take an average of 60 minerals, some 60 minerals out of the soil, but we sprinkle three back on: nitrogen, potassium and phosphorous and the plants grow, but there's compelling evidence that the actual mineral content of the plants is really anemic, compared to what our forefathers had.
I think that's one of the reasons why many of these very promising nutritional remedies come out of non-agricultural land. It's soil that hasn't been exploited or overtreated with pesticides and herbicides that perhaps poison the bacteria in the soil and make it difficult for the roots to take up the minerals in organic form.
Thanks for the question, though.
The Chair: Thanks, Mr. Boudria.
We have one other witness from Health Canada, so, with your approval, members, I will thank Mr. Lunney, on your behalf, both for his work on this bill and for his testimony this morning and, following that, invite Mr. Philip Waddington, who is the director general of the Natural Health Products Directorate within the Health Products and Food Branch of Health Canada, to come forward, please, and make his presentation and answer our questions.
Welcome, Mr. Waddington.
Mr. Philip Waddington (Director general, Natural Health Products Directorate, Health Products and Food Branch, Department of Health): Thank you very much Madam Chair for this opportunity to come here and speak today.
It's my pleasure to run through the work that we've undertaken within the Natural Health Products Directorate.
I'd also like to express my appreciation to Mr. Lunney for the enthusiasm with which he described the benefits that we can all consider when looking at natural health products, vitamins and minerals etc. It is because of that enthusiasm that we've seen that we did specifically follow through on the prior recommendations from the standing committee on health as how we move forward within Health Canada.
The natural health product regulations were published in Canada Gazette, part two on June 18, 2003 and came into force on January 1 of this year. They pertain to the sale, manufacturing, packaging, labelling, importation, distribution and storage of natural health products.
We have to differentiate perhaps between some of the actions that Mr. Lunney described which were under the previous regulations and actions that would or and have been taken under the current regulations and Mr. Lunney correctly pointed out that there were new regulations in place but we have to be able to differentiate those two.
I'd also like to put on the table that there are two issues that we're talking about, one is around natural health products and the other is around schedule A. We should try to keep them a little bit separate as they are not the same issue and we should address them as such.
So the new regulatory framework governing natural health products will promote ready access to natural health products that are safe, effective and of high quality, many of the things that Mr. Lunney has spoke about.
The regulations will help consumers to make informed decisions by requiring that natural health product labels accurately reflect the ingredients and claims that are appropriate for those products. Outlining any contra-indications or warnings that are also appropriate for the product that is being taken.
As was stated in 1999, the government accepted all 53 recommendations from the standing committee on health and the regulations that we put forward were based upon those recommendations that we accepted. In developing the natural health product regulations the government consulted widely before going to Canada Gazette, Part 1.
There was cross country consultations on the overall regulatory approach, there was specific consultations on good manufacturing practices, standards of evidence, restruct an expert advisory committee to look at issues of scientific matter, we had an industry liaison committee, now called the management advisory committee to look at the business around how the regulations are unfolding.
The resulting regulations taken into account the concerns and input of the full range of industry, consumers, practitioners and stakeholder groups that we heard through those consultations.
While the Standing Committee on Health recommended that Health Canada set out an appropriate definition of natural health products and amend the Food and Drugs Act accordingly as Mr. Lunney has stated, he also advised that the necessary processes to amend the act not delay the implementation along the regulatory lines that can follow through in the meantime and that is we had been pursuing.
Under the Food and Drugs Act natural health products currently, depending on the outcome of these discussions, must be classified as either a food or a drug since there is no third category currently.
As agreed through the consultations that we undertook across the country natural health products are taken for therapeutic reasons and not for cleric reasons or to address hunger or thirst, taste etc. Health Canada is of the view that they are more similar to drugs than they are to foods for this reason.
While a third category distinct from both foods and drugs was considered, an amendment at that level of the act would have been necessary and due to the timelines and legislative processes requires for such a change and to follow through on the Standing Committee on Health's recommendation to not delay in making progress in the meantime, it was decided that the natural health products would be considered drugs under the Food and Drugs Act and act amendments be considered under legislated renewal.
There are specific regulations now in place pertaining to natural health products. Bill C-420 poses to change the definition of food and drug of the Food and Drugs Act. It also requested sub-section 31 and 32, which relate to prohibitions on advertising and labelling of products and schedule A, which was described as a list of 40 diseases against which claims cannot be made, that they be repealed. In regard to the definition of food, the bill proposes the addition of dietary supplements, herbs and other natural health products.
The natural health products regulations ensure the level of protection and range of information which Canadians have requested through extensive consultations.
Throughout our consultations, people continually told us they wanted to have access to the appropriate information, most of which what was described here with respect to what should be required on labels, claims it should be allowed, and those that are permitted and required under the current natural health product regulations.
Under the food and drug regulations, foods can only make limited diet-related or nutritional content claims, and not, for example, treatment claims, which many people want to discuss with natural health products.
It was a recommendation of the standing committee on health that a full range of claims be allowed for natural health products. The natural health product regulations are consistent with that recommendation and provide for that to occur. Furthermore, during consultations, held both by the standing committee on health and the Natural Health Products Directorate, consumers have continually requested a system of good manufacturing practices be in place to ensure that what is on the label is actually contained in the bottle, and a system of pre-market assessment of health claims to make sure that these products are effective for what people are taking these products to do.
Generally, foods are not subject to pre-market review and assessment. The natural health products regulations contain provision on pre-market review and assessment of products, and a system of good manufacturing practices in response to the consultations that we've undertaken.
With respect to Schedule A, Bill C-420 poses that sections 3.1 and 3.2 and Schedule A be repealed. We have to keep in mind that sections 3.1 and 3.2 and Schedule A pertain to more than just natural health products, but to all of the products under the Food and Drugs Act: foods, drugs, natural health products, medical devices, cosmetics, etc. The scope of that kind of a repeal has to be considered in that light. A fundamental revision of section 3 and Schedule A would require careful consideration of the other elements of the Food and Drugs Act, such as definitions on advertising, etc.
In 1998, the standing committee on health found that many stakeholders felt that Schedule A still served a useful purpose, but needed to be modernized. It proposed that a working group with representatives from various stakeholder groups be formed to review section 3 and Schedule A. As you will see from the Health Canada website, that working group has been struck and the recommendations from the working group will soon be reviewed by the new management within Health Canada.
In closing, the natural health product regulations have been developed through extensive consultation with a full range of input from stakeholders: industry, consumers, practitioners, academics and other regulatory bodies looking at the international scene of how these products are regulated in other countries.
The regulations reflect the recommendations of the standing committee on health's 1998 report on the regulation of natural health products. Health Canada is confident that they provide an appropriate regulatory framework for these products by ensuring that Canadians have access to safe, effective, high-quality natural health products.
One of the issues that was continually raised in the previous presentation was around risk and how these are low-risk products. Many of the current pharmaceuticals are natural in basis. It's estimated that approximately one-third of all pharmaceuticals come from a natural base. Just the fact that something is natural in origin does not in and of itself mean that it is a safe product. I would agree that most natural health products are safe, and I'm not trying to say otherwise, but the fact that it's safe does not....
For example, if we regulated herbs as foods, Digitalis, which is a herb, foxglove, would then be regulated as a food, since they are proposed to be mutually exclusive. Not having the option to be regulated as a drug, and thereby prevent Digitalis from falling under the drug definition. What we have tried to do with our regulations, which I believe is in the spirit of Mr. Lunney has been discussing, is to ensure that consumers in an OTC, or an over the counter format, have access to the safe, effective, natural health products.
Where we've drawn the line between those is those that would require a prescription, such as Digitalis, would fall under the drug regulations. Those that are safe and effective for self-care use would fall under the natural health product regulations. So I believe we are achieving the goals that were set out through the consultations, through previous discussions, through recommendations from the standing committee on health.
At this point, I would be pleased to answer any questions pertaining to anything around natural health products.
The Chair: Thank you, Mr. Waddington. We'll begin with Mr. Merrifield.
Mr. Rob Merrifield: Okay. Let me just get this in layman's terms, if I can. It seems to me there are two issues, here. One is saying that what's in a natural health product bottle, that we make sure that what it says on the package is actually what is inside the bottle.
Mr. Philip Waddington: Correct.
Mr. Rob Merrifield: I don't think the change here would challenge that. Is that correct?
Mr. Philip Waddington: The change, as it's proposed, would put natural health products under foods. Foods do not require good manufacturing practices to ensure that what is on the label is in the bottle.
Under the current regulatory framework for natural health products that came into force on January 1, there are good manufacturing practices that require exactly that. So depending on whether or not those provisions were moved into food provisions to obtain exactly what is in place right now, that would be challenged.
Mr. Rob Merrifield:
So what you're saying is that we could change that by regulations?
Mr. Philip Waddington: If we moved natural health products into foods there would not be good manufacturing practices and you would not be able to sufficiently guarantee that what is on the label is in the bottle. To do that you would have to implement GNPs, the same as what we've done under the current regulations, so you would obtain the same level of regulatory oversight, but under a different framework.
Mr. Rob Merrifield: So you mean a food in a store, you're saying that what it says on the package is no guarantee that that's what is--
Mr. Philip Waddington: Not that there's no guarantee, there is what's called HACCP, hazard analysis critical control point. They look at ensuring that products are safe and they make sure that they're not adulterated.
Mr. Rob Merrifield: Okay, so that's what we're saying.
Mr. Philip Waddington: Yes, but with natural health products, because you're looking for an effective dose, the difference between having 300 mgs of an ingredient and 400 mgs of an ingredient may be consequential. With the food, that would not be so. And so the requirements around the specificity with which a food has to be produced are not as tight as the requirements around the specificity with which a natural health product has to be produced.
Mr. Rob Merrifield: Okay, but that's something that could be worked out under regulations as far with the food products.
The other one is the claim, and that's the one that I sense the department has the bigger problem with, which is that when it says it claims to do certain things on the bottle that they have to verify that it actually happens and it's the cost of verification that becomes prohibitive with natural food products. Is that the essence of the problem here?
Mr. Philip Waddington: I'm not sure if I understood your question correctly so I'll answer it, but if I'm not correct then please do so.
The claim issue for what should be allowed and how it should be allowed under natural health product is of interest to Canadian consumers and that was a large part of our consultations. We did specific consultations on what's called standards of evidence. And what standards of evidence are is to say how much information and what kinds of information should have to be provided to allow for a claim to be able to be made. And under the natural health products regulations we have a gradation ranging from, if there are double blind placebo controlled trials, as you would find in a drug, great; we'd also look at other trials that maybe weren't blinded; we'd look at cohort studies, which means that you're looking at how different population groups change over time; we'd look at expert opinion reports, which would mean that maybe where a number of individuals who are experts in the field who were determining something from a product; we'd look at how it was regulated in other countries; and we'll look at traditional literature. So, for example, using the Echinacea example, if Echinacea was traditionally used for treating colds and flues, that also would be able to be supporting evidence behind the treatment. So we'd look at a wide range of what could be allowed to not cause that kind of a cost restriction around developing those standards that I think you were mentioning.
Mr. Rob Merrifield: So that gets into the cost restrictives. So do you see that as of January 1 and the new rules we're under, is that going to be cost prohibitive for some of these products to get on the market?
Mr. Philip Waddington: Any time that there are regulations in place of any kind there are going to be costs associated. But I do not believe that the research required to support a claim would be in excess of what should be required and what has been required by Canadians. So there will be costs to gather that information. For example, you will have to go on to the web to look up garlic to show that you've got evidence to support its use in helping with colds or blood or whatever you use it for. But you do not have to redo tests or you do not have to undertake those studies on your own. So there is a small cost of gathering research, but there is not an extensive undertaking of a cost prohibitive type of study that would be required.
Mr. Rob Merrifield: Some of the industry are saying the opposite. They see it as being very cost prohibitive. I guess that my frustration in this is that last year I've spent, when it comes to natural food products, most of my time trying to get Health Canada to see the light on Empower Plus as a product that leaves freedom of choice for individuals to choose it if they see it's helping them. I've got testimony stacks that high in my office of individuals who have seen this product as beneficial to them. Now I'm no expert in it, but I can tell you that I read this compelling evidence and I, for the life of me, can't understand why Health Canada is having such a difficult time allowing it to come in across the border.
Now the shutting down of the study, I don't understand exactly what went on there. I understand there is a court case and maybe you can or can't comment on some of that, but I do know that when it comes to freedom of choice of individuals to be able to choose a product for their own benefit is something that we should applaud in Canada, in a democratic country.
Mr. Philip Waddington: I agree.
Mr. Rob Merrifield: Can you tell me what's going on there and what the opposition really is from the department?
Mr. Philip Waddington: Sure. As you've noted, there is a court case that is underway and so I will speak perhaps in generic terms around some of the more general topics that may be under consideration.
With respect to research, I know that there was an application under the previous regulations for research. I was involved with the discussions undertaken. It was finally left where we said to the researcher “It looks like you can go ahead. Please submit your final report.” and it didn't come in. So we can't move forward on research that doesn't proceed.
Mr. Rob Merrifield: But wasn't it shut down?
Mr. Philip Waddington: Under the previous food and drug regulations a company has to make an application for clinical trials to Health Canada and they did not make that application.
Mr. Rob Merrifield: But they were doing the clinical trials and it was shut down in the middle wasn't it?
Mr. Philip Waddington: It was for that reason because they did not comply with the previous regulations.
Mr. Rob Merrifield: We can take issue with that.
Mr. Philip Waddington: Sure and people will. So that researcher has been in dialogue with us and I suspect that will be undertaken shortly; it'll proceed. So again, under the current regulations the concerns that were previously outstanding I believe have been addressed.
With respect to products such as any generic vitamin/mineral product there are two things to consider. One is, should people have access to it? I think everybody would say yes. So under our regulations as a vitamin/mineral product, I'll say a general vitamin/mineral product would go to market unencumbered because of its use as a vitamin/mineral.
The question then becomes, can its claim be to treat bipolar? That's one that I'm not sure of. I think that there is adequate debate around the table from consumers as to whether or not claims such as bipolar are best treated through consultation with a physician, or on their own. Now some people will say perhaps you should be able to prevent it and in the sort of pre-disease, or in a preventative manner, you can make those claims, but once you have it the treatment should be undertaken with the cooperation of a physician.
Those kinds of discussions I believe should be exactly the reason why we should go to consultation around Schedule A, which is the issue there. That's why I say we have to differentiate between natural health product regulations, which would allow the product to market and Schedule A which may come in place with respect of the labelling.
The Chair: Ms. Grey.
Miss Deborah Grey: Thank you, Philip, we appreciate that presentation.
I'm also new to the committee.
Can you tell me what your background is? Where did you come from to be an HP Director?
Mr. Philip Waddington: I started in January 2000. My background is as a naturopathic doctor so I'm well versed with respect to vitamins, minerals, herbs, etc. I also have an MBA and I have a background in business. I have come from the business community as well.
Miss Deborah Grey: Great, thank you.
It's good to know that you know a whole bunch about this, obviously, probably more than all of us except James.
I think if we're going towards where we need to get to, and that is of course the ultimate health and well being of Canadians, you just mentioned something about preventative versus the treatment of it. Obviously, all of us hope to be more preventive than just looking at treatment.
I was kind of interested there in this Empower Plus, what you were speaking of. It almost seemed like the cycle was interrupted there somehow. You know they're trying to do the clinical research available, but they didn't apply under the correct regulations or something so then it gets shut down. Well then how do you carry on with it? It makes it very difficult for people who are trying.
I've met with people in my office as well who have been taking Empower Plus and if it makes them better I think we should be looking at that a whole lot more than saying, oh, the regulations weren't followed, or we really want to make sure that you're on prescribed drugs all the time. It seems to me, as James mentioned in his testimony, and I know you were here listening to it too, that science is observation. If you look and feel better and you're not costing the health system per se, be in hospital or psychiatric appointments, that ought to be a good thing we should be celebrating and finding ways to make these regulations work.
Mr. Philip Waddington: I agree. I could stop there, but I'll go on.
To be clear, the regulations allow natural health products to make either structure functions, risk reduction, or treatment/cure claims. So you can make the full range of claims you're allowed under the natural health product regulations. The comment around perhaps the way consultations have unfolded around Schedule A is what you're looking at there.
Schedule A is a list of severe diseases, so psychiatric disorders would be captured under there. The question that we hear in discussion is, should people be able to self manage this whole range of diseases. some people, and some of us around the table, believe that there should be more information out there and exactly the kinds of things that Mr. Lunney was describing should be allowed. There are other people, not around this table perhaps, but that we hear in consultation that say that section 3 in Schedule A should be enhanced to prevent advertising for pharmaceutical products because if you open up the door on one it has caveats across all of the products that are out there. So we have to make sure that is undertaken with a balanced consideration.
With respect to that product in particular, again, the regulations will allow the product to go to market, it's Schedule A that we have to consider. What we hear in consultation is that in the pre-disease state, in other words this product may reduce your risk of getting or preventing you from getting a certain disease, perhaps it should be opened up. In the post disease state people are less comfortable. This isn't my decision to make, but I think we should hear from the entire consultative process.
Miss Deborah Grey: Under what category would medicinal marijuana fall?
Mr. Philip Waddington: It would not fall under the natural health products regulations, if that was the ultimate question, because there is an exclusion...
Mr. Rob Merrifield: Did you shut that one down?
Mr. Philip Waddington: The trial itself, to be clear, because the government's responsibility is to ensure that consumers, when they're being experimented on, are done so in a way that protects their health, and what happened was Health Canada said, to be clear when you used the term shut down, the trial wasn't so much shut down. What they said is the people who are currently on it should continue, but you should not bring new people on to it until you've come into compliance with the regulations. People weren't taken off the program that they were on. They weren't engaging new people as they went forward.
Under the current regulations, we allow for things such as with herbs, you may not know exactly which component of the herb was being effective, to be taken into account, so the clinical trial would proceed under our regulations.
Miss Deborah Grey: What's interesting is Empower Plus was shut down then. Why didn't those “x“ people just be allowed to continue, but no new guys on, I wonder.
Mr. Philip Waddington:
With respect to EMPower Plus, that's under investigation in the courts, and so I'll speak generically again. If there is a company that has a product on the market that is not in compliance with the regulations, then the regulations are in place for a reason, and so the government can take action against it.
With respect to a product such as that, we even bent over backwards to show how people could still potentially obtain access to it through personal importation, while it was undertaking the process of--
So again, under the current regulatory framework this product would pass through the regulations and go to market. We have to realize that there has been a relatively substantial change that took place on January 1, and could not make decisions now on actions that were taken prior to that.
Miss Deborah Grey: Thank you.
The Chair: Mr. Ménard.
M. Réal Ménard: Alors, il y a des choses que je ne suis pas sûr de comprendre. Ce que j'en comprends, c'est que Santé Canada n'appuierait pas le contenu du projet de loi de notre collègue, en disant: «On considère que les produits de santé naturels sont consommés pour des fins davantage thérapeutiques que nutritionnelles, et on pense que les produits de santé naturels doivent demeurer dans la catégorie des médicaments.» Je pense que c'est votre prémisse. Est-ce que je vous interprète correctement en disant cela?
Mr. Philip Waddington: What you stated is correct, but it is not the entirety of why we believe that it should stay within the current definition under the drug side. It's not just that it is taken more for therapeutic reasons, but also to ensure that the safety of Canadians is being addressed, to make sure the label accurately reflects interactions of the products, to make sure the GNPs are in place, to show that the product hasn't been...okay.
M. Réal Ménard: J'ai d'abord trois questions. Pourquoi ne pas aller vers une troisième catégorie, comme, selon ce que j'avais cru comprendre, le Comité permanent de la santé l'avait recommandé? Quelle est la différence entre la mise en marché, l'approbation et l'étiquetage pour la catégorie des médicaments et pour la catégories des produits de santé naturels? En quoi le fait d'avoir la catégorie des aliments dans laquelle seront inclus les produits de santé naturels peut-il constituer un déficit d'information pour les consommateurs et éventuellement une menace? C'est ce que je veux comprendre.
Mr. Philip Waddington: Okay.
M. Réal Ménard: Il faudrait que vous nous déposiez un document pour que nous comprenions bien l'un et l'autre. C'est là-dessus, finalement, que nous serons appelés à voter. Quel est le processus d'approbation, d'étiquetage et de mise en marché quand c'est un aliment, quand c'est une drogue, et en quoi y a-t-il un danger pour les Canadiens et les Québécois?
Mr. Philip Waddington: If I caught your questions, I'll run through the three of them. You had four, actually. You said you wanted something from ....
All of the information around how a food comes to market, what is required under labeling, how a drug comes to market and how a natural health product comes to market, it's all on the web. It's there in both languages and we could perhaps see if we can pull that together.
The first question is, why did we not proceed to a third category? We looked at that very closely. We looked at the recommendation from the Standing Committee on Health that said, “Go for a third category”. That was for the first recommendation, I believe. I think it was the eighth one that said, “...but don't let that process stop you from making the benefits and the changes that you can accrue now under a regulatory change”. So we focused our efforts within the directorate at achieving those changes within the regulations, and legislative renewal which is looking at how all of this legislation comes together, was looking at what would occur under the act. We undertook our role for the regulations and we let legislative renewal undertake its role for the act.
We were fortunate to be successful first, and so now we have the regulations in place, but that engagement around how the act should unfold is still underway. There are consultations on that which I'm sure you're aware of right now.
You asked what is the, I believe you said, difference between the marketing approval and what would be on the label of a food, and that which would be on a natural health product?
Within the natural health product regulations, you have to state how much of an active ingredient, for example, how much echinacea is your product--you wouldn't have to state that on your food--and you have to state the part of the plant being used, to address, again, Mr. Lunney's correct concern that maybe you want the root, but they're using the flower or vice versa. That is within the requirements of natural health product regulations.
You have to list all of the non-medicinal ingredients--that is, on the food regulations, but not on the drug regulations--so this is something that we've required again in response to the consultations that have been undertaken.
You're not to have cautions or warnings on foods because they're permitted to be taken ad libitum. You're allowed to take foods freely without concern for overdose, whereas with respect to natural health products, the correct dosing would be on the label to say, “Take three capsules twice a day”, or what is appropriate.
The GMPs, again, to require that the product is as it is in the bottle as it is on the label, is in place under the current regulations, but not under the food regulations.
With respect to bringing a product to market, there is a pre-market approval for a natural health product, or a drug, for that matter, that would require that the claim on the label be appropriate to the evidence provided. The natural health product regulations allowing for quite a range of evidence coming right through clinical trials through to traditional use, to ensure that appropriate--
M. Réal Ménard: Pour être sûr que je comprends bien, concernant les produits de santé naturels, le producteur doit aussi déposer l'équivalent d'une monographie clinique? Pour être en conformité avec Santé Canada, qu'est-ce que le producteur, celui qui produit l'échinacée, doit déposer comme documents aujourd'hui?
Mr. Philip Waddington: I believe your question is, would a natural health product have to undertake a clinical trial to bring its product to market? The answer is, no. You can have an appropriate claim, depending upon the full range of standards of evidence. For example, for echinacea, they would just have to demonstrate that there are two independent sources that concur that this product was used for, for example, colds and flus in its traditional use. So it would come to market with simply two documents that said, “This has been used for colds and flus”, to demonstrate the safety and efficacy. That would demonstrate its traditional use.
For popular products, we're also generating monographs. I'm not sure if this is some of what was around your question. Health Canada, not industry, is generating monographs to say, for example, “Echinacea, taken in the following doses...”, with the appropriate label warning, should be able to go to market. Under those circumstances, all the manufacturer would have to do is say, “I agree with that information you've already pulled forward”. They wouldn't have to do any further work with respect to looking for safety and efficacy. So for products such as echinacea, there are a number of routes to market, many of which are very simple.
The Chair: Thank you very much, Mr. Ménard.
Hon. Don Boudria: Just a couple of questions. If I understood correctly, your method of doing this now--and I don't mean to put words in your mouth, you can tell me where it's wrong as I say it, please--is you did it this way by regulation essentially, because it was a far less complicated way of achieving an immediate result than it would have been to wait until you could get the legislation through the House. Is that essentially it?
Mr. Philip Waddington: Essentially, yes.
Also when we looked at and I know there are a number of proposals before the House around the third category, even under those circumstances you would still have to follow it with legislation that put in place regulations that were appropriate for that and so we
Hon. Don Boudria: I understand how the government legislative process can...it is somewhat burdensome, as it has to be perhaps. Not long ago I was leader of the government and the last step of reviewing the bill to ensure that it matches with the cabinet document is something the House leader does before any bill is introduced in the House and the number of steps it's gone through before reaching there is absolutely unbelievable to someone who has not worked in PCO or something like that. It is quite intricate. It is quite, some would argue, burdensome, but others would say well developed, whichever handle you want to put on it. Anyway, it takes a long time.
The way in which it has been made under the regulations, instead of legislative amendments, does it stop you in any way from achieving the results wished for in that report of some time ago?
Mr. Philip Waddington: The 52 recommendations from the committee on health?
Hon. Don Boudria: Yes. Or do you think that....Did you achieve everything by doing it this way?
Mr. Philip Waddington: That report was the foundation upon which all of our steps were taken. So the way in which we have approached it saved the recommendation of pursuing change at the level of act is exactly what we've achieved through these regulations.
Hon. Don Boudria: All right.
Well, insofar as handling the issue of these particular products, that has been achieved--is that what you're saying--by way of regulations? In other words, if we replaced that with the legislation sought for in that report, it won't give you anything that you have now? Do I have it correctly?
Mr. Philip Waddington: Just to be clear, when you say that report and you're referring to Mr. Lunney, I just want to clarify it, the 52 recommendations, what was sought in that has been achieved in my opinion through the natural health product regulations.
Hon. Don Boudria: All right. Well, that's the information I'm looking for.
So, essentially, if we say that we've not adopted that third category sought for in this report, then you're saying, if I understood you correctly, maybe not, but we've achieved the same thing by way of regulation. Am I correct?
Mr. Philip Waddington: Correct.
Hon. Don Boudria: I see.
I think that helps us to focus on what is the shortcoming--if there is one and you're telling us there isn't--in adopting that which was sought for in that regard in the report. It'll be interesting to see whether Mr. Lunney agrees with that assessment, because I think it is essentially what we're trying to find out, isn't it, when it's all said and done?
Thank you. That's it for now.
Mr. Philip Waddington: I would also add that if we did write in a third category and call it the food, drugs and natural health products act, we would then have to define natural health products and create regulations to deal with that category. So we'd be back at the exact same place, but under a different title.
The Chair: Thank you.
You're going to get your wish, Mr. Boudria, because the next questioner is Mr. Lunney and I'm sure he's going to....
Hon. Don Boudria: I hope that in his question he makes a statement about that which we just heard.
Mr. Gilbert Barrette: To agree.
Mr. James Lunney: Thank you very much, Madam Chair.
I appreciate the indulgence of all committee members because I know there is interest in this and I don't want to monopolize all of the questioning. You have been generous with me in the time.
I want to just say, first of all, though, Phil, the question is in response. And this is what Canadians are asking because people that know these issues...now, you and I know Naturel products probably better than most people in the room. That was a career for you and it was a career for me. I use them and I know the benefits of them. But the response that we're looking at here, and what Health Canada has set up, the question really is: is it real, have we really accomplished what was asked for the committee, or is it an illusion?
Frankly, the language--and we've seen this in other areas of government--those of us who have been around here for a while know that language can be crafted very well, but realities can actually, like air currents, can be moving a different direction.
When you say here you consulted broadly, that is absolutely true. There were extensive, exhaustive consultation, and the health committee did that, but what is not clear and what, frankly people in the industry are beginning to feel about this, as they've looked what's gazetted, is that it's an illusion and it's an actual betrayal of the process that Canadians were believed to expect, because without the third category...I notice that you put there--I know that the committee also said--“But we shouldn't delay”, as important as regulation is, we shouldn't delay. And so what has the department done, but they've taken the legislative amendment, which would have put this in our proper category, and they've lumped the legislative renewal, the Food and Drugs Act, in with the Quarantine Act, the Radiation Emitting Devices Act and the Hazardous Product Act--as looking at a whole new way to regulate health, we'll look at all these acts together.
Now, as people around this table know, that's not something that will be done quickly. Meantime, we've brought in all these regulations, a mountain of them, an elephant-load full of regulations--and some of them are very good regulations--and we've put them squarely under the drugs side of the equation.
Now, with all due respect, Mr. Waddington, Phil, when you said that we couldn't have the good manufacturing practices, we couldn't have the regulations and office inspections under the food portion--
Mr. Philip Waddington: We didn't, not we couldn't.
Mr. James Lunney: What we're advocating here is simply taking the regulations that have been developed and placed under drugs and moving them under the food style, so along with it would go the good manufacturing practices, would go the office inspections, would go the quality controls that Canadians expect. We'd simply move it onto a different culture, one that is more consistent, with the low risk and the natural nature of these products.
Now, you said that Canadians take these things for therapeutic reasons, but that's not the only reason. That can be true, but most Canadians are not taking them, really, for therapeutic reasons, in spite of recommendations from chiropractors or naturopaths and rarely, occasionally, from doctors, thank goodness, but many are taking them because they want to be healthy and they're taking them without anybody's advice, really, professionally, because they want to be healthy.
And health and disease is a continuum, as you and I would both recognize. So to create an artificial branch here, that while in the preventative stage maybe you could take it if you want to, but once you have a disease, well, then you have to be regulated, it's an artificial obstructionism there that protects the interests of professionals more than it does the public. So recognizing that if we have a natural product, surely, we would want to make it available to people.
I guess a final--
The Chair: Your question.
Mr. James Lunney: My question, yes.
The regulations would be moved accordingly, under that umbrella. I have to take exception to some of those comments that we made, and also to the way the department has lumped this whole regulation of food and drugs in with these other things. That's not going to be a timely process. And that's, frankly, what Canadians would spell: betrayal.
Don, with all due respect--he has moved from the table--in responding to the regulations, by lumping the legislative renewal that was promised in with all of these other acts, it's a five-year or a ten-year project, although we might hope that it might be sooner. In the meantime, all of this other process will be going on regulating and bringing companies...and it's quite clear that the smaller manufacturers will be squeezed out of business by the weight of this bureaucracy, while we go through an extensive consultation, and who knows how many Parliaments, in addressing other health concerns. That's what Canadians are very upset about and it needs to be addressed, frankly, Phil.
We're not against what's in the bill. There's a lot of good work done. We have Dr. Chan over here, who sat on that transition team. It might be interesting to hear from him. He was one of the people who wrote these, Peter Chan over here, who has a PhD. in biochemistry, who sat on this regulatory committee. He's here. He sat on this board.
Those regulations, when you said in that transition team report that it's out of step with science. And tinkering, you're saying we'll set up an expert committee to tinker with that schedule, schedule A, and consider which diseases might be removed, it's clear that the schedule, itself, needs to be removed. It doesn't serve the public interest.
Phil, that's really what Canadians want to hear happen. That's what I'm hoping that the health committee, who's used to seeing fog...there's a lot of fog in Ottawa, actually, considering the elevation we have here. Maybe it's the river, but even here on the Hill we get a lot of fog. Frankly, we want to blow through that fog and begin to do something that's right for Canadians.
Basically, Madam Chair, that's what I wanted to say, simply, in response to this.
Mr. Philip Waddington: Is your question, why would take so long? I'll try to respond in a way that is appropriate.
The difficulties that you correctly outline around the legislation process required to change things at the level of the act is exactly why we should undertake this kind of approach at the level of regulations. The acts all intertwine with one another in ways that are far more complicated that I would have originally envisioned. When you start to change one it has impacts on another. That is why the government of Canada has said we're going to look at this as a unit, otherwise we are going to achieve an approach that is going to either duplicate areas, or leave areas open. That's not my area of expertise, but that is why we end up in the scenario that we currently find ourselves.
With respect to the products themselves, if we're just going to take the same regulatory framework, and move it under foods, that would be a semantic change. I'm sure that is not the intent of anybody because you want to undertake a substantial change. If we undertake a substantial change, which would be to look at what is actually in the bill, which is what we commented on, by making herbs and natural health product foods, we've taken away their ability to make the claims because those are what make them drugs.
Mr. James Lunney: That's where we disagree, though.
Mr. Philip Waddington: If you look at the definition, foods are defined as what they are, and drugs are defined as what they do.
Mr. James Lunney: That's what the bill would change, the definition.
The Chair: I have one more questioner, and time is slipping away.
M. Gilbert Barrette: Merci, madame la présidente.
À partir de ce qu'on connaît de la consommation de la population et à partir de l'objectif visé par ce qui est déposé, quelle serait votre suggestion pour moderniser la réglementation par rapport à la façon dont les gens ou la population utilisent les produits naturels? Pour rendre cela acceptable, quelle suggestion nous faites-vous?
Mr. Philip Waddington: Excellent question.
The regulations around natural health products are relatively new. There is a learning process, both within the government and within the industry, as how to best apply them. Right now what I would do is I would continue with exactly what is undertaken right now, with the same kind of vigilance towards public consultation around how they are unfolding as we had under their development, to ensure that the concerns that are being raised by industry, and by consumers, are being addressed.
When I receive a call from the media right now, it will probably be critical, I'm pretty sure of that, because the media is usually critical of government, but I'm not sure if it will be critical because the regulations are too strict, and therefore preventing access, or, too lax, and therefore, not ensuring safety. The fact that I'm not sure which side it is going to come in on is comforting to me because I think that means that we have a relatively good balance between those two, which are on opposite sides of the scale. The next thing around the bill that is on the table is with respect to schedule A. I personally believe that we should have a serious look at that because, personally, and I'm speaking from my own point here, very close to Mr. Lunney's considerations around schedule A. I think many Canadians, myself included, would want to have as much information around products as there can be. However, as an employee within Health Canada, I know that it is not my view that has to carry forward but that of Canadians. When we consult, I recognize that there are other people who believe there should be no advertising around any health problems. Again, it's probably somewhere in between those two that we'll achieve a common approach.
The next step I would take with respect to Schedule A, I believe, is that we should have public consultations on that to make sure that all of the views are on the table, and then proceed on that in an open and transparent manner.
Mr. Gilbert Barrette: If I understand well, there was already a public consultation—
Mr. Philip Waddington: With Schedule A?
Mr. Gilbert Barrette: On the subject, I presume.
Mr. Philip Waddington: The subject has two components. One is around natural health products. I believe that the approach that we're taking is the correct one, and we should continue to move forward in a manner that addresses concerns as they're raised allowing for the new regulations to take effect.
The other issue with respect to Schedule A, there was a 1998 standing committee on health report that said it should be reviewed to ensure that only appropriate diseases are listed. There was a recent undertaking, a standing committee on health around advertising and drugs where it's perhaps less sure that we should make those changes. Since the views do change, I believe that's the one that we should go for public consultation on. We've had an advisory group where we've brought in stakeholders from media, from practitioners, from consumers, from special health care groups, etc., and they have produced recommendations on how they feel Schedule A should be modified in section 3. I believe that should be the foundation of public consultation. The process has been under way. We're at the stage where, very surely, we would go to public consultation on Schedule A, and, I believe that would be the appropriate step to take next.
Mr. Gilbert Barrette:
Ma dernière question, it goes with the 53 recommendations. The question I was asking Mr. Lunney a while ago, why didn't you, why were you not influenced by these recommendations?
Mr. Philip Waddington: Influenced?
Mr. Gilbert Barrette: Yes.
Mr. Philip Waddington: We were driven by them. These are the foundations upon which all of our actions have been taken. People say to me “Why are you doing this?” I say “Well, in recommendation number 12 it says such-and-such”. People say “Those were so long ago”. I say “Until I get direction otherwise, those are my marching orders”. So we are more than just influenced by these recommendations. They are fundamentally behind all of the actions that we've undertaken.
Sorry, Madam Chair.
The Chair: Thank you, Mr. Barrette.
Mrs. Bev Desjarlais (Churchill, NDP): This is just in response to Mr. Lunney's, and yours and obviously Health Canada's differences of opinion of where they should fall, whether it be drug or food, and the fact that it has been set to maybe be looked at with three or four other issues. I don't want to try to find that. I'm not as versed with what's in front of me as the others are.
Is there a quicker way of addressing that rather than having it done in a four or five year down the road checkout with three or four other bills? Is there a quicker way of putting in place just dealing with that one issue in Schedule A? Have you got the specifics as to exactly what other bills of legislation it will affect?
Mr. Philip Waddington: Again, there are two issues around legislative renewal. One was the definition of natural health products and whether or not there should be a third category at the level of the act and how that would unfold. I believe that would be part of the legislation and to a larger consultation.
With respect to Schedule A, it's also within legislative renewal, but there is, in addition, as I believe you're requesting, a separate working group that was struck to look specifically at Schedule A. If there are consultations on that and recommendations that the government move forward on, then that could occur outside of legislative renewal. So the definition issue, which I believe would still fall under regulations is probably not the main driver. I think what you're looking at is Schedule A and section 3, and that is already slotted to undertake a separate regulatory--
Mrs. Bev Desjarlais: There was a comment made that it would affect other pieces of legislation. That's part of the reason why it would take that much longer, what's included in that. I want the specifics of what other legislation it would affect that's creating this big problem of dealing with it now.
Mr. Philip Waddington: To be clear, just to make sure I'm using the words correctly. We all made comments about how young we are, we started four years ago. I don't know if that'll give me flexibility, here.
With respect to the act, there's the Food and Drugs Act. Schedule A and section 3 pertain to all of the regulations under that act. They do not pertain to other regulations, such as radiation emitting devices, and the other ones being considered under legislative renewal. So food, drugs, medical devices, cosmetics, natural health products, those would be captured under Schedule A and section 3, but that is a contained unit.
With respect to legislative renewal, they're also looking at radiation emitting devices, the Food and Drugs Act. There are a number of different acts that are being considered in unison. Section 3 and Schedule A is only within the Food and Drugs Act.
Mrs. Bev Desjarlais: So there really isn't that complicated process of having it affect other acts. That's why we can't really get into it right now.
Mr. Philip Waddington: No. With respect to section 3 and Schedule A, that does not affect other acts. That unit can be and has been taken out and looked at specifically because it is a distinct unit. That's the one where the recommendations and the working group are going to the ADM, and under which I envision she will probably undertake consultations on that.
The interactions between the acts are with respect to the four that have been discussed by James Lunney.
Mrs. Bev Desjarlais: I still am not clear as to what that interaction is between those acts.
Mr. Philip Waddington: They're all health and risk directed acts.
Mrs. Bev Desjarlais: Oh my goodness, so is transportation safety.
Mr. Philip Waddington: This was undertaken, this is not my area of focus. I can perhaps gather information around legislative renewal, but I'm not under that. If the goal is to separate out Schedule A, then that has already been undertaken and I believe should be allowed to proceed. I think that's ultimately where your questions seem to be heading, but I'm not sure.
Mrs. Bev Desjarlais: My ultimate intent was to really find out why there's such a roadblock in place and how many more reasons and roadblocks can be put in place just to not get on with dealing with the issue.
Mr. Philip Waddington: Legislative renewal is not my area of focus so I can...
Mrs. Bev Desjarlais: That's fair enough, it's not you that's taking to task here.
The Chair: Thank you Madam Desjarlais.
Mr. Lunney has asked for one minute to do a sum up and then I need about a half a minute to talk about process.
One minute James.
Mr. James Lunney: Thank you Madam Chair.
The first point is, you know the Food and Drugs Acts itself is about 20 pages long. The regulations for natural health products now are something like 500 pages. First of all is it really appropriate for all of this regulation to come outside of the scrutiny of the members of Parliament and that's really I think a very good question.
I want to say right now the attention of the country is on what's going on in another committee, just in the other building here and we all know that Mr. Guité is testifying right now. I want to suggest to you that frankly there's an issue here that is very important to Canadians and it frankly is scandalous.
If Canadians understood how health, something that would advance their health is being obstructed systematically by the way it's interpreted bureaucratically. I think most of them would be reacting even worse than they are to what's happening down the hall.
People get mad when you steal their money but if we have bureaucratic obstructionism and regulation that actually obstructs the delivery of health care rather than promotes it, I think that the shaking that this place is having right now would in fact be magnified and the ground is going to split.
Madam Chair, I hope that members will take this issue seriously because we have an opportunity and I think people in the department mean well, but we have an opportunity to move this framework into a venue that will advance the interests of Canadians and put the patient back at the centre of the focus and with proper consultation I think we can do that.
I think we can regulate these things in a manner that will release information to Canadians and give them counsel and advice that will help advance health care of Canadians and build healthier Canadians that reduce the costs and the burden on the system and I'm hoping that all members will assist in that process. Thank you Madam Chair.
The Chair: Thank you Mr. Lunney and thank you Mr. Waddington for coming and helping us out today.
To my colleagues on the committee, you'll recall that last year, last week we agreed on the next four meetings and I would like to remind you that Tuesday is the auditor general and it's got something to do with...I'm sorry, it's the minister on estimates, yes.
So you have to dig out your estimates and on the Thursday it's the auditor general on assistive devices which is another thing that's falling into this legislative renewal thing. In case you might have some time on the weekend you might want to look at your estimates and be ready for next week.
We will talk about our next steps with this piece of legislation when we have completed those few commitments we made last week and we'll have another session on future business but for now this is what we committed to do and we've done it. We'll talk about where we go with this at the next session, devoted to future business.
Seeing no hands I thank everybody for being here and I declare this meeting adjourned.