HEAL Committee Meeting

37th PARLIAMENT, 3rd SESSION

Standing Committee on Health

EVIDENCE

CONTENTS

Thursday, April 22, 2004

Á

1110

The Chair (Ms. Bonnie Brown (Oakville, Lib.))

The Chair

Mr. James Lunney (Nanaimo—Alberni, CPC)

Á

1115

Á

1120

Á

1125

The Chair

Mr. Rob Merrifield (Yellowhead, CPC)

Mr. James Lunney

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1130

Mr. Rob Merrifield

Mr. James Lunney

Mr. Rob Merrifield

Mr. James Lunney

Mr. Rob Merrifield

Mr. James Lunney

Mr. Rob Merrifield

Mr. James Lunney

Mr. Rob Merrifield

Mr. James Lunney

Mr. Rob Merrifield

The Chair

Miss Deborah Grey (Edmonton North, CPC)

Á

1135

Mr. James Lunney

Miss Deborah Grey

Mr. James Lunney

Miss Deborah Grey

Mr. James Lunney

Miss Deborah Grey

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1140

Hon. Don Boudria (Glengarry—Prescott—Russell, Lib.)

Miss Deborah Grey

Hon. Don Boudria

Miss Deborah Grey

Hon. Don Boudria

Miss Deborah Grey

Hon. Don Boudria

Miss Deborah Grey

The Chair

Miss Deborah Grey

The Chair

Mr. Réal Ménard (Hochelaga—Maisonneuve, BQ)

Mr. James Lunney

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1145

Mr. Réal Ménard

Mr. James Lunney

Mr. Réal Ménard

Mr. James Lunney

Mr. Réal Ménard

Á

1150

Mr. James Lunney

The Chair

Mr. Gilbert Barrette (Témiscamingue, Lib.)

Mr. James Lunney

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1155

Mr. Gilbert Barrette

The Chair

Hon. Don Boudria

Mr. James Lunney

Â

1200

Hon. Don Boudria

Mr. James Lunney

Hon. Don Boudria

Mr. James Lunney

Â

1205

The Chair

Mr. Philip Waddington (Director General, Natural Health Products Directorate, Health Products and Food Branch, Department of Health)

Â

1210

Â

1215

The Chair

Mr. Rob Merrifield

Mr. Philip Waddington

Mr. Rob Merrifield

Mr. Philip Waddington

Mr. Rob Merrifield

Mr. Philip Waddington

Mr. Rob Merrifield

Mr. Philip Waddington

Mr. Rob Merrifield

Mr. Philip Waddington

Â

1220

Mr. Rob Merrifield

Mr. Philip Waddington

Mr. Rob Merrifield

Mr. Philip Waddington

Mr. Rob Merrifield

Mr. Philip Waddington

Mr. Rob Merrifield

Mr. Philip Waddington

Mr. Rob Merrifield

Mr. Philip Waddington

Mr. Rob Merrifield

Mr. Philip Waddington

Mr. Rob Merrifield

Mr. Philip Waddington

Â

1225

The Chair

Miss Deborah Grey

Mr. Philip Waddington

Miss Deborah Grey

Mr. Philip Waddington

Miss Deborah Grey

Mr. Philip Waddington

Mr. Rob Merrifield

Mr. Philip Waddington

Â

1230

Miss Deborah Grey

Mr. Philip Waddington

Miss Deborah Grey

The Chair

Mr. Réal Ménard

Mr. Philip Waddington

Mr. Réal Ménard

Mr. Philip Waddington

Mr. Réal Ménard

Mr. Philip Waddington

Â

1235

Mr. Réal Ménard

Mr. Philip Waddington

The Chair

Hon. Don Boudria

Mr. Philip Waddington

Hon. Don Boudria

Â

1240

Mr. Philip Waddington

Hon. Don Boudria

Mr. Philip Waddington

Hon. Don Boudria

Mr. Philip Waddington

Hon. Don Boudria

Mr. Philip Waddington

Hon. Don Boudria

Mr. Philip Waddington

The Chair

Hon. Don Boudria

Mr. Gilbert Barrette

Mr. James Lunney

Mr. Philip Waddington

Mr. James Lunney

Â

1245

The Chair

Mr. James Lunney

Mr. Philip Waddington

Â

1250

Mr. James Lunney

Mr. Philip Waddington

Mr. James Lunney

Mr. Philip Waddington

Mr. James Lunney

The Chair

Mr. Gilbert Barrette

Mr. Philip Waddington

Mr. Gilbert Barrette

Mr. Philip Waddington

Mr. Gilbert Barrette

Mr. Philip Waddington

Mr. Gilbert Barrette

Mr. Philip Waddington

Mr. Gilbert Barrette

Mr. Philip Waddington

Â

1255

The Chair

Mrs. Bev Desjarlais (Churchill, NDP)

Mr. Philip Waddington

Mrs. Bev Desjarlais

Mr. Philip Waddington

Mrs. Bev Desjarlais

Mr. Philip Waddington

Mrs. Bev Desjarlais

Mr. Philip Waddington

Mrs. Bev Desjarlais

Mr. Philip Waddington

Mrs. Bev Desjarlais

Mr. Philip Waddington

Mrs. Bev Desjarlais

The Chair

Mr. James Lunney

·

1300

The Chair

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CANADA

Standing Committee on Health

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NUMBER 011

l

3rd SESSION

l

37th PARLIAMENT

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EVIDENCE

Thursday, April 22, 2004

[Recorded by Electronic Apparatus]

Á  (1110)  

[English]

    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.

    (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 member's bill, and we'll invite him to describe its contents to us.

    Mr. Lunney.

    Mr. James Lunney (Nanaimo—Alberni, CPC): 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.

    The subject of Bill C-420, which is before the 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. It has to do with the regulation of natural health products.

    For some members who haven't been present when the discussions happened in the House, or perhaps weren't focused on it, here is a quick review.

    Bill C-420 has to do with the way natural health products are regulated. It's a very concise bill, 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 of 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.

    Briefly, as to the history, there's a document in French and English that I hope has been circulated by the clerk. It's simply a review of the issues that I was asked to write. It was published in a magazine called Vitality, which circulates in Toronto--a circulation of some 50,000. It's a brief review of the issues, about five pages.

    The issues that frame the argument are outlined in that document, and I hope all members have it so they can review, but basically this controversy goes back quite a number of years, to around 1996 or 1997 and 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 that 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, Natural Health Products: A New Vision. 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 will be hearing from officials as to what has transpired.

    The transition team made reference to these sections that my bill would like to amend, subsections 3(1) and 3(2). To make the issue simple, subsections 3(1) and 3(2) basically state that it's illegal to advertise or label that a vitamin, mineral, herb, or a natural product will influence a whole schedule of diseases. That schedule is called schedule A. 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 on which you're not allowed to either label or advertise.

    The issue goes well beyond labelling and advertising because it seems that the way it has been interpreted and applied, it means that as soon as a health claim is made it then triggers a subsection 3(1) violation and the product is considered to be 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 “Sections 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. They've been tinkered with a little bit over the years, but the conclusion of the committee says “They do not serve any purpose that cannot be accomplished adequately by other sections of the legislation or regulations. ” Furthermore, they say “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 is time that the legislation and regulations reflect the prevailing science. ”

Á  (1115)  

    That's what the committee recommended. The minister accepted the committee's report and the transition team's report. Canadians were led to believe that those subsections would be removed and that a third category would be created--not food, not drugs, but in the middle, natural health products, in order to regulate vitamins, minerals, and herbs, things that come out of nature, which are basically low-cost, non-patentable items that promote health.

    Unfortunately, the government chose to ignore those recommendations and instead brought in something quite different; that is, natural health products and a whole new office of natural health products. That has now become the Natural Health Products Directorate. I'm sure we'll be hearing shortly from Phil Waddington, the director of that department. There is no third category. This is a subclass of drugs for the purpose of regulation. Natural health products are considered drugs.

    Out of that have come some real problems, which persist today. I want to briefly highlight what that means. Scientists have told us in the last number of years, as the transition team correctly noted, that vitamins and minerals are vital to our health. Those of us who read the newspapers are aware of the almost daily reports. A few weeks ago there was a story about 400 international units of vitamin D having a marked effect on multiple sclerosis. There's a new appreciation for how important vitamins and minerals are. Unfortunately, it's still illegal to tell Canadians that directly.

    I'd like to raise a few of the issues by way of commentary. We're all aware that heart disease is the number one killer in this country. I find it rather bizarre, and I think many Canadians would, that even though there are some 2,500 articles in the medical literature about the importance of a simple vitamin supplement called folic acid.... Folic acid is a vitamin that women take when they're pregnant to avoid neural tube defects. They recommend 400 micrograms, which is less than half a milligram. That costs less than half a penny a day. 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 the Heart and Stroke Foundation and the Canadian Cardiovascular Society, would advertise this. This article is from the Canadian Journal of Cardiology, July 2001. Unfortunately, I don't have it in both languages, so I can't table it. In this article they document that in the past 10 years there has been substantial epidemiological evidence for an association between homocystine and the risk of developing heart attacks, strokes, and thrombosis. They go on to say, “While folate therapy alone”--that's folic acid alone, which costs less than a penny a day--“is sufficient to correct elevated plasma homocyst(e)ine levels in most patients....” They go on to say, “Supplementation has also been proven to be effective in improving endothelial function, and possibly causes the regression of carotid plaques.”

    What I'm saying by quoting this is that we now understand the biochemistry, that blood vessels get damaged when you don't have enough folic acid. You get a buildup of this substance called homoscystine. It damages the vessels. Then cholesterol gets deposited in damaged vessels, which leads to hardening of the arteries. It seems to me that's something Canadians would want to know about. There are 2,500 articles, Madam Chair. And it goes beyond heart disease. Health Canada will advertise in the Canadian Journal of Cardiology, but it's illegal to let Canadians know directly about something as simple as that. I think everyone in this room should be taking a folic acid supplement. I took mine this morning, and I hope you all did as well. It may be taken in conjunction with other vitamins.

    I picked up a bottle of folic acid at Costco for $2.99, not that I recommend that people buy it there. The bottle contained 365 tablets, enough folic acid to last the year. That would help the average Canadian lower their homocystine.

    Researchers at the University of British Columbia were saying this years ago. Why are we testing for cholesterol? It has a low correlation with actually developing heart disease. But we know that homoscystine has a high correlation with developing serious heart disease, but we're routinely not making recommendations, and it's so easily corrected with a simple vitamin supplement.

Á  (1120)  

    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--well, it's not in my riding; it's on Vancouver Island. It's Biomedica, and they produce a product that has been very effective in helping people with arthritis. I know people here on the Hill who are taking this medicine called Recovery; it's a simple vitamin and mineral compound. It recently won international recognition in the horse industry for helping horses with tendon and arthritis problems.

    Interestingly enough, they also did work with ballet dancers in Denmark, and they found that dancers found they had phenomenal recovery by taking these products. But it's illegal to tell people that Recovery could help them with their arthritis.

    It's relatively cheap, it's non-patentable, and it's produced by a Canadian company. It's internationally recognized, and guess what? People would say horses are different from humans, but frankly, we do a lot of animal research, and animals are made out of the same things we are, Madam Chair.

    Unfortunately, right now Health Canada is trying to suppress Biomedica, 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 is important because many of the members here will remember that a few months ago we had a bunch of ladies here with red umbrellas. These were people who were taking a natural health product called Empower Plus. It's a vitamin and mineral product that has helped people with bipolar disease.

    I just have to use this as an example, Madam Chair, if you'll allow me, because it illustrates the problem with the ways these are being regulated. A company in Alberta developed a product that was helping people with bipolar, and 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, but they hit lows that are so low they're at high risk of suicide. This has traditionally been regulated with various drugs--or managed.

    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 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 that it was so effective and promising that they were published in four peer-review journals under the leadership of Dr. Bonnie Kaplan of the University of Calgary. A researcher at Harvard, Dr. Charles Popper, picked it up as well, as did another doctor, Dr. Miles Simmons, for example. They all published the responses they'd seen of 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 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 into proper medical management of their drugs.

    Now, the name of one of these people was Sabina, and I'll just use her as an example. She lives here in Ontario, and she came to the Hill. Some of you might have talked to her; she was right here in front of the Hill with her red umbrella. Sabina had been 18 years on psychiatric drugs, and she estimated she'd spent 10% of her 22 years of married life in hospital. That's costing us a lot of money.

    She'd been on the vitamins and minerals for a couple of years and her liver function tests had improved, her liver that had been in great trouble because of the drugs she'd been taking all those years. Her diabetes had cleared up with her taking the vitamins. She's working, she's paying taxes, she's volunteering, and along comes Health Canada and wants to take away this product that has given her back her life.

    She's not trying to kill herself or her husband any more. The husband, who, thank God, was a faithful man who stayed with her all those years, thinks he has a new wife. Now, 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 is this. I don't have this in both languages, but they say a picture is worth a thousand words. I have here pictures of research done by Dr. Bryan Kolb 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 are of rats that have had lobotomies. Now, some people would think that's a nasty thing to do to a rat, but Dr. Kolb would cut out sections of their brains and then see what functions they could and couldn't do. Then he would test various things to see if they'd improve function.

    Dr. Kolb put these rats with lobotomies on Empower Plus. Not only did they recover their function, amazingly, their brains actually regrew. I have pictures here; perhaps members would like to see them. There are only a few of you here, and you'll be glad to look at these pictures. A picture says a thousand words.

Á  (1125)  

    This is a world-renowned neuroscientist.

    Frankly, Madam Chair, there's something wrong with this picture. If 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 that it needs to be fixed.

    Madam Chair, these issues were discussed before the House, and I know members had a lot of interest in this file. I appreciate the support of our colleagues on both sides of the House. I was very pleased that the members agreed to send the matter here to the 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, and we even had to fight for our room today. The time is short legislatively, but I would hope we could take the steps that are necessary.

    What my Bill C-420 would do is implement the promise the government made in accepting the transition team report. It would change these antiquated sections 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 Empower Plus, because there's so much information available on them to illustrate the problems. But believe me, it's far broader than that. It applies to something like chromium picolinate for diabetes, and we could go on for some time.

    I know the members may have questions. I'd just like to suggest, for the record, to members and to this committee that this is an issue that needs to be addressed in order to advance health care that works in Canada. I think 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 here. I was in discussions with officials and I was asked this question about the bipolar, for example. They raised the question of whether bipolar was something that should be self-treated. I thought about that question for a while and it really disturbed me because it seems to me that's a question only a bureaucrat would ask.

    Have we forgotten that the centre of the whole issue is really the patient? Are we going to defend the letter of a regulation that goes back to 1934 over the interests of the patient? What if patients could take a simple vitamin supplement, fix themselves, and get off the waiting list?

    Madam Chair, 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 people 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 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 and heard an awful 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 they have tremendous impact on the ability of individuals in Canada to be able to receive products of their choice that don't harm them.

    That really boils down to the first question, and maybe you would answer this, James. With respect to the number of dollars that are actually spent for natural food products through freedom of choice now in Canada, do you have a number?

    Mr. James Lunney: Yes, and thank you, Rob--Mr. Merrifield--for that question.

    Canadians right now spend about $15 billion a year on pharmaceutical drugs. The Fraser Institute reviewed the natural health products regulations published in 2001, and their take on these regulations was that they were a cure worse than the disease. According to that article published by the Fraser Institute, their studies showed that Canadians are spending about $1.6 billion a year on natural health products--vitamins, minerals, and herbs--because Canadians themselves believe these products improve their health. Many of them notice that when they take vitamin C, they don't get colds as often, and that when they take other antioxidant vitamins, they don't get sick as often.

Á  (1130)  

    Mr. Rob Merrifield: You say $1.6 billion a year in natural food products compared with the $15 billion on pharmaceuticals--that's what you're saying. We just went through a study this last fall that showed that somewhere around, let's say, conservatively 10,000 deaths a year were caused by adverse drug reactions in this country. That's probably very conservative, but there's a study out there that will verify that in May, I think, or whenever it's completed and reported.

    Can you tell me, on the natural food products, about 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—it is something people, particularly from Asia, take for a calming effect—because of a case where there apparently was some contamination, I think 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. If you took too much vitamin A, for example, 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 it wants of it.

    Let me make a point, because you mentioned the research dollars they use here—the $1.6 billion compared with $16 billion spent on pharmaceutical drugs. The other thing with the regulations here is the new office of natural health products is going to commit $1 million to research on natural health products, but we spend nearly $1 billion federal dollars a year largely researching pharmaceutical issues. That's roughly 10:1 in what's spent on pharmaceuticals, and yet we only have a 1,000:1 ratio in what we're willing to put into natural health products—$1 million.

    Why is it, in these new regulations, that you have to be an MD or a dentist 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 PhDs in neurosciences and neurophysiology or biochemistry, by and large. I just want to put that on the record as well. It's a real concern when people see this 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 or your change is?

    Mr. James Lunney: That's half of it, Rob: that the definitions would change. But also, it would gut these subsections 3(1) and 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—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 sections. I think Canadians themselves—

    Mr. Rob Merrifield: 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. Are we compromising anything by making this change?

    Mr. James Lunney: I don't see 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 a Chinese product where for thousands of years we are not aware of harm. Buyer beware, but we are not aware of harm. 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; then nothing ever came of it. When you talk about Health Canada and the difference in what's spent—$15 billion on pharmaceutical drugs versus $1.6 billion—who's benefiting by it? We've had some discussions 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?

Á  (1135)  

    Mr. James Lunney: That's a question that needs to be answered by somebody. 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 somebody asked you whether people should be responsible for their own diagnosis and treatment, vis-à-vis Empower Plus. Your response here was, “That was a question only a bureaucrat would ask.” I'd put it to you that this is maybe a bit of a slam on the bureaucrats. Would it be something that only someone in the pharmaceutical industry would ask?

    Mr. James Lunney: That's another 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 that is really at the heart of this. We're not trying to protect people from bogeymen who 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 in this House and with Health Canada 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. They're taking their vitamins in the morning.

    I hope everyone here did. Monsieur Barrette and I had a little discussion about that this morning, and I would encourage him to take more than orange juice.

    More and more Canadians are taking vitamins and minerals to build healthy bodies. It seems we need a shift in the emphasis in health to 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 absolutely swamp the system ten or fifteen years down the road now, because we are all aging.

    Someone on this committee a couple of weeks ago said something about “food supplement junk”. I was rather surprised by that, because it sent the signal to me that this was all weird and wacky, and that it's all the leftovers from the hippie generation in the sixties who are participating in this, taking natural health products as supplements.

    I don't think that's a bit true, but there's an attitude, I think, that we need to overcome. 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 but then does not accept its recommendations, what could we do to put pressure on from all sides of the House to make sure that happens?

    Mr. James Lunney: I think frankly the committee and the House, as members of Parliament, 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 whom feel their lives are at risk....

    We have a couple of people in the room right now, though they're not scheduled as witnesses, who have had their lives transformed from taking this product and have seen 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 Alberta division of the Canadian Mental Health Association, is aware of at least 25 families who have had people revolutionized through taking that particular vitamin product; yet here is Health Canada moving to obstruct delivery of the product. He is outraged.

    I know there are people in the industry who say, and the standard medical response, if you'll excuse my saying it this way, to what Richard or Philippe would say is, “That's anecdotal evidence”, or to what Sabina would say or what Ron LaJeunesse has observed is, “That's anecdotal.” But I have to say it on the record: the foundation of all true science is observation. I studied science. That's one of the first things we learned: 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 at that.” 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 it? If you're looking at short-term versus long-term costs, if the pharmaceutical industry is making piles of cash....

    I'm going to put this on the record here, that in 15 years of being a member of Parliament I have been bribed once, in my office. That was by a pharmaceutical company. I am not criticizing them all, but of all the years I have been here, I got an actual physical bribe from one of them. 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 there are good people and lousy people in every field, but it's just—

Á  (1140)  

    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. This is 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 it, 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. Either it stands up or it's expunged from the record. That's a criminal act that's alleged to have been committed right now. I don't think it's right for us to use the 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: An anecdotal criminal charge.

    Miss Deborah Grey: —while we're looking at pharmaceutical or prescription drugs.

    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. 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've just said. I said there are good people and bad people in everything.

    We've just spent a whole lot of time and effort in this committee talking about prescription drugs. You yourself have made comments. I know we have frustrations with this, and 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 I'm sorry. I think we'd better look at it pretty seriously.

    The Chair: Thank you.

    We'll go to Mr. Ménard now.

[Translation]

    Mr. Réal Ménard (Hochelaga—Maisonneuve, BQ): Thank you. May I remind you, Madam Chair, that all MPs enjoy parliamentary privilege on the committee, right?

[English]

    I'm going to speak in French, of course, because I am a romantic man, as you know.

    Mr. James Lunney: Yes.

Á  (1145)  

[Translation]

    Mr. Réal Ménard: I’m a bit surprised by your bill, Mr. Lunney. Of course, in the Bloc Québecois, my colleague Bernard Bigras and I, though more he, have been keeping an eye on this matter. We voted in favour of the bill so that it would end up here, before the committee, but we wouldn’t be prepared to pass it now. I want that to be very clear. There are amendments that we feel must be made to it.

    First of all, this committee already made a study of natural products several years ago. Ms. Picard was our representative at that time. What the witnesses came to say, I was told – and this can be checked by reading the report by the committee – was that the Food and Drugs Act should not be amended to include natural health products under the heading of “food,” but that a third category should be created.

    So why, when it came to a parliamentary initiative bill, did you not take account of the conclusion of that report by the Health Committee? It looks as though your bill doesn’t go far enough compared to what the Committee itself recommended several years ago.

    So my first question is this: why did you not go along with creating a third category? It would have been a lot easier for the Bloc Québecois to support your bill and to vote in favour of your bill, even though it has the merit of putting the whole issue of natural health products back on the table. So that’s my first question.

[English]

    Mr. James Lunney: Well, first of all, let me say, Mr. Ménard, I appreciate your support with your caucus, your intervention with your caucus and Mr. Bigras to support the bill coming to committee. I appreciate that very much. I'm willing to consider amendments. I think the language of the bill lends itself to needing a little tweak anyway, because of the antiquated language that's in that Food and Drugs Act--it goes back so far. I think it does need a little bit of amendment.

    For example, it says something about chewing gum...if I can get back to the actual bill and its wording. In the definition of “food and drugs”, for example, it says “'food' includes any article manufactured, sold or represented for use as food or drink for human beings”--and it has chewing gum in here--“chewing gum, and any ingredient that may be mixed with food for any purpose whatever”. 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 whatever”. 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. 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, I heard they were looking at what the easiest way would be of amending the existing situation--all the movement toward an office of natural health products that's been done, and the development of a new natural health products directorate now. What would be the easiest way to amend it? We came to the conclusion that the easiest way was to move it under the category of “food”. We had food and we had drugs.

    Because of their long history of use--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. 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.

[Translation]

    Mr. Réal Ménard: I recall that, maybe two years ago, I’d asked Health Canada to give an information session on natural health products. If your bill were adopted by this committee and later passed by the House, what is your understanding of the impacts it would have on labelling? If natural health products were included in the food category, what would that mean as far as labelling is concerned?

    I was told that one of the difficulties that arise is that, where labelling is concerned, they want to consider natural products with an obligation to really give a very complete monograph not only of their composition, but also of what that may mean in terms of drug interaction when they are taken with other types of drugs.

    So if the committee passes this bill and it’s sent back to the House, how do you think natural health products are going to be handled, as far as labelling is concerned?

[English]

    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, the way they are framed--complications of medications, interactions, and all of the possible uses--are items that even with a medical product, a drug, are impossible to get on a simple label on a bottle. You'd never get all that information on a bottle--and they can't with drugs either. So when you're starting to talk about all the possible ramifications, permutations, and combinations of possibility, what is being asked for by people who think that way sounds exhaustive.

    Realistically, we have to understand 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 darned glasses. To read what's on a label on a vitamin bottle, when you have it in both languages.... There is only so much information you can get on a tablet bottle, and by the nature of the products, they're not huge packages.

    So I think there are issues about what information is practical to put on a bottle. It can't be exhaustive. The regulations, if you look at them, actually call for things that are impossible to deliver. Of course, with drugs they put in a package insert with a lot of fine print, which if anyone ever reads it would give you most of the information, but that's not exhaustive either.

[Translation]

    Mr. Réal Ménard: I have one last question. I, for one, take Echinacea. I take it for granted that Echinacea is a natural health product. I take Echinacea to ensure that my system is not weakened when I feel that I might be getting the flu or something like that.

    What are the Health Canada requirements, to your knowledge, for a natural health product to get on the shelf? A clinical monograph is not required, but what is required, to your knowledge, at Health Canada, for a product to be sold over the counter and a natural health product? Let’s take the example of Echinacea. I think that everyone knows what Echinacea is; probably everyone takes it. As far as you know, what are the Health Canada requirements?

Á  (1150)  

[English]

    Mr. James Lunney: It's 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 the Canada Gazette part II 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 time schedule for the industry to respond and make sure those regulations are complied with.

    I think it's of interest that with some of these products, for example, echinacea...and I'm not sure about the specifics, but for some products the therapeutically beneficial ingredient may be in the flower itself, it could be in the leaf, or it could be in the root. I think there are some concerns that you'd 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 echinacea, but you'll have the wrong part of the plant in there and the active ingredient would be misrepresented.

    No one is questioning the need for good manufacturing practices and that Health Canada and the new department ought to be doing office inspections and product inspections to make sure that what is on the label is in the product and that the facilities are clean, respectable, and so on. Those are all necessary things, and I think Canadians accept, understand, 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. Acetyl L-carnitine, an amino acid, helps with cognitive function. We should all be taking it, but it's illegal to buy it in Canada. It's a simple amino acid. It's a building block, a protein, and it would help people with memory. All of us in the House here could probably use a hit of that, especially at this time of year.

    The Chair: Thank you, Mr. Ménard.

    Mr. Barrette.

[Translation]

    Mr. Gilbert Barrette (Témiscamingue, Lib.): Thank you, Madam Chair.

    I’m new to the House of Commons. I have a very general question: what is the main objective of this bill?

[English]

    Mr. James Lunney: Monsieur 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 around the table here range upwards in age, but we still think we're young. I don't like to call myself a new MP any more; I say I'm slightly used.

    Some hon. members: Oh, oh!

    Mr. James Lunney: Anyway, most of us around the table are slightly used now, but welcome to the club, Monsieur Barrette, who came recently to the House in a by-election.

    Now, Monsieur 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 important part of this report. It is a key part, a part that goes back to this antiquated section that goes back to something like 1934, as best we can determine from the records. It has been tinkered with a little bit by changing the schedule of diseases.

    But frankly, it seems the section has been used in the wrong way. It seems the sections about labelling and advertising have been used to actually remove the most effective products as soon as a health claim is made, and there's something about this that intrinsically doesn't seem right. Canadians may take a product, based on scientific research that shows it would help them with their cognitive function, their thinking, or would help them with their blood sugar metabolism, yet because it's simple, because it's a mineral or an amino acid, Health Canada moves to take it off the market.

    The obstacle seems to be these subsections 3(1) and 3(2) and schedule A in the Food and Drugs Act. The transition team said they were antiquated and out of step with science and that we needed 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 them as a subclass of drugs and maintain these subsections. Frankly, the behaviour of the department to this day--just recently sending the RCMP into Raymond, Alberta, to shut down production of one of the most promising natural health products, one that could revolutionize 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 is these antiquated sections the transition team and the committee who looked into this...and I give full marks to the committee that did the report Natural Health Products: A New Vision. They came up with 53 recommendations, and then out of that came the transition team.

    Canadians, the ones who are listening and reading and taking products to help themselves, have been watching this process, believing something was going to happen to allow an advance for the natural health products they've come to trust. They are very frustrated right now because they see something else happening. They're saying, oh my gosh, we thought we were getting a third category--which Mr. Ménard was addressing--but in fact they're not getting a third category; they're getting a subclass of drugs. That's not what they wanted. They want these things to be regulated as the low-risk, low-cost products they are, not under the same type of regime drugs have.

    My hope would be that the committee would hear and respond to the science, making sure that science is not shut out from advancing simple things that would actually help produce Canadians who are more resistant to disease. Then they wouldn't be spending their time lining up in the hospitals and going on those darn waiting lists we're all concerned about. If there's some way to build a healthier Canadian, one 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 we're asking for in the bill. It's probably not the only way; there's room to consider amendments, but there's a shortage of time. I think that with the terrible situation 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 and help make these products more available--unless we're aware of harm. If we are aware of risk to people--and there are some documented cases--then let's look at protecting people from things they need protection from, but to invent bogeymen 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've put it before the House on behalf of people in the industry. They 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.

Á  (1155)  

[Translation]

    Mr. Gilbert Barrette: Given that Health Canada doesn’t want to consider certain recommendations, what is the main argument, or what are the main arguments, for not implementing them or, at the very least, for hesitating to make changes?

[English]

    The Chair: Excuse me, Mr. Barrette. We actually have a witness from Health Canada who, I think, would be a better person to answer that question once we finish with Mr. Lunney.

    I think we'll move now to Mr. Boudria.

    Hon. Don Boudria: I'm in no particular rush, but....

[Translation]

I’d like to come back to what Mr. Ménard raised concerning labelling. I certainly won’t say that I’m young or that I’m new to Parliament, because this would be a bit of an exaggeration on two counts, my having spent close to 30 years as an elected representative in some capacity or another. I must say, though, that this is the first time in a few years that I’ve been on the Health Committee. So we must of course ask our witness, our colleague who is a health professional, to be patient with some of us.

First of all, I’d like to congratulate him on his initiative aimed at rekindling this debate.

    I come back to what Mr. Ménard raised a while ago concerning labelling requirements from the time all that is called a food product. Of course, I’m not – I repeat – a health professional, but the concerns surely have something to do with the fact that it’s not only the consumer who reads the ingredients. It’s no doubt often a doctor who’s going to tell a patient to make sure, if he or she takes something, not to take such a product because it contains ingredients that might have such and such an effect. He might add that we know this thing has been popular in the region for some time, that lots of people are taking it, but that it can’t be taken with what he’s prescribing today. Doctors can make such recommendations.

    Is there a concern in this regard?

[English]

    Mr. James Lunney: Well, 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 recommended this to my patients. We should all be taking a chromium supplement. I checked the vitamin pill I'm taking here in Ottawa, which is different from what 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 their blood sugar is beginning to become more stable, they simply adjust their own insulin requirement, and that's a very good thing.

    We all know, as Mr. Merrifield mentioned earlier, that there are very big concerns about what happens when people are on drugs, especially in the long term. We all acknowledge that pharmaceutical drugs can be life-saving when administered 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 quick; it could save a life.

    Natural products that are low-risk are by nature 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.

  (1200)  

    Hon. Don Boudria: Yes, but my question was not about that. I accept what you're saying, of course, but 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 but sometimes meaningless and a lot of times not read anyway--but it is also there, presumably, for other health care professionals to know in case they're giving the patient some other product that might react in an adverse way with an ingredient that is in there but not labelled if it isn't done in that particular way. That was more 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?

    Hon. Don Boudria: No, perhaps not unavailable, but just ensure that we do the other protective measures.

    You see, I'm not coming at this as 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 in rural Canada, probably from aboriginal citizens. We were told to boil a particular weed and that was good for a particular ailment. 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.

    So I don't 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, mean I'm not against that. I'm just looking at ensuring that we have categorization a little bit in the way 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 hear 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 I'd want to know, even as a natural health practitioner, is what meds they're taking. 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 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 was actually a pharmaceutical graduate, who had done his thesis--I guess it was a 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, and 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, this is a big issue in the province of Quebec, where I believe les produits de santé naturelsare consumed even more widely 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. If we remember back to something that caused a big stir 60 years ago, something called Essiac, a nurse named Rene Caisse who got this aboriginal remedy for cancer in those days. Essiac was her name spelled backwards. But it was basically an aboriginal remedy of slippery elm bark, powdered sheep sorrel, 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 years. Each crop will take an average of 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 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.

  (1205)  

    The Chair: Thank you, 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 the opportunity to come here and speak today. It's my pleasure to run through the work 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 we can all consider when looking at natural health products--vitamins, minerals, etc. It is because of that enthusiasm that we specifically followed through on the prior recommendations of the Standing Committee on Health as to how we move forward within Health Canada.

    The natural health product regulations were published in the Canada Gazette, part II, 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 between some of the actions that Mr. Lunney described, which were under the previous regulations, and actions that have been taken under the current regulations. Mr. Lunney correctly pointed out that there were new regulations in place. But we have to differentiate between those two.

    I'd also like to put on the table that we're talking about two issues: one is around natural health products, and the other is around schedule A. We should try to keep them separate, as they are not the same issue, and we should address them as such.

    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 Mr. Lunney 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 and outline any contraindications or warnings that are also appropriate for the product that is being taken.

    As was stated in 1999, the government accepted all 53 recommendations of the Standing Committee on Health, and the regulations that we put forward were based upon those recommendations. In developing the natural health product regulations, the government consulted widely before going to the Canada Gazette, part I. There were cross-country consultations on the overall regulatory approach and specific consultations on good manufacturing practices and standards of evidence. We struck an expert advisory committee to look at issues of a scientific nature. We had an industry liaison committee, now called the management advisory committee, to look at how the regulations were unfolding. The resulting regulations take into account the concerns and input of industry, consumers, practitioners, and stakeholder groups, which we heard from 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, it also advised that the necessary process to amend the act not delay the implementation of the regulatory changes, and that is the route we have been pursuing.

    Under the Food and Drugs Act, depending on the outcome of these discussions, natural health products must be classified as either a food or a drug since there is no third category.

    As agreed through the consultations we undertook across the country, natural health products are taken for therapeutic reasons and not for caloric purposes or to address hunger, thirst, taste, etc. Health Canada is of the view that they are more similar to drugs than foods for this reason.

    While creating a third category distinct from both food and drugs was considered, an amendment at the level of the act would have been necessary. Due to the timelines and legislative processes required for such a change and to follow through on the Standing Committee on Health's recommendation not to 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 would be considered under legislative renewal. There are specific regulations in place pertaining to natural health products.

    Bill C-420 proposes to change the definition of “food” and “drug” of the Food and Drugs Act. It also requests that subsections 3(1) and (2), which relate to prohibitions on advertising and labelling of products, and schedule A, which is described as a list of 40 diseases against which claims cannot be made, 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 that Canadians have requested through extensive consultations.

  (1210)  

    Throughout our consultations, people continually told us they wanted to have access to the appropriate information, most of which was described here with respect to what should be required on labels, claims that 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 make only 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 them for.

    Generally, foods are not subject to pre-market review and assessment. The natural health products regulations contain provisions on pre-market review and assessment of products and a system of good manufacturing practices in response to the consultations we've undertaken.

    With respect to schedule A, Bill C-420 proposes that subsections 3(1), 3(2), and schedule A be repealed. We have to keep in mind that subsections 3(1), 3(2), and schedule A pertain to more than just natural health products. They apply 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 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 it 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 that 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 and 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, then digitalis, which is a herb--foxglove--would be regulated as a food, since they are proposed to be mutually exclusive. It would not have the option of being regulated as a drug, which would 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 what Mr. Lunney has been discussing, is to ensure that consumers in an OTC or over-the-counter format have access to the safe, effective, natural health products.

    Where we've drawn the line between them is that those that would require a prescription, such as digitalis, would fall under the drug regulations, and 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.

  (1215)  

    The Chair: Thank you, Mr. Waddington.

    We'll begin with Mr. Merrifield.

    Mr. Rob Merrifield: Let me just get this in layman's terms, if I can.

    It seems to me there are two issues here. One is that we make sure what's in a natural health product bottle is what it says on the package.

    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 we could change that through 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 GMPs, the same as 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: Are you saying that for a food in a store, what it says on the package is no guarantee of what's--

    Mr. Philip Waddington: It's 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 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 milligrams of an ingredient and 400 milligrams of an ingredient may be consequential. With food, that would not be so. 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.

  (1220)  

    Mr. Rob Merrifield: Okay, but that's something that could be worked out under regulations with the food products.

    The other one is the claim, and that's the one I sense the department has the bigger problem with. When it claims to do certain things on the bottle, they have to verify that it actually happens, and it's the cost of verification that becomes prohibitive with natural health products.

    Is that the essence of the problem here?

    Mr. Philip Waddington: I'm not sure if I understood your question correctly. I'll answer it, but if I'm not correct, then please correct me.

    The claim issue, what should be allowed and how it should be allowed for a natural health product, is of interest to Canadian consumers, and it was a large part of our consultations. We did specific consultations on what's called standards of evidence. Standards of evidence say how much information and what kinds of information should have to be provided to allow for a claim to be made. Under the natural health products regulations, we'd have a graduated range from double blind placebo-controlled trials, as you would find in a drug, which is great. You'd have other trials, which may not be blinded. We'd look at cohort studies, which means you're looking at how different population groups change over time. We'd look at expert opinion reports, which would mean that a number of individuals who are experts in the field would determine something from a product. We'd look at how it was regulated in other countries, and we'd look at traditional literature. Using the echinacea example, if echinacea were traditionally used for treating colds and flus, that also would 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 cost restriction around developing those standards, which is what I think you were mentioning.

    Mr. Rob Merrifield: That gets into the cost restrictions. So do you see that as of January 1 and the new rules we're under it's going to be cost-prohibitive for some of these products to get on the market?

    Mr. Philip Waddington: Any time there are regulations of any kind in place, there are going to be associated costs. But I do not believe the research required to support a claim would be in excess of what should be required and what has been required by Canadians. There will be costs to gather that information. For example, you will have to go onto the web to look up garlic to show that you have evidence to support its use in helping with colds or blood or whatever you use it for. But you will not have to redo tests or undertake those studies on your own.

    So there will be a small cost of gathering research, but there won't be an extensive undertaking of a cost-prohibitive study required.

    Mr. Rob Merrifield: Some of the industry are saying the opposite. They see it as being very cost-prohibitive.

    I guess my frustration with this is when it comes to natural food products. Last year I spent most of my time trying to get Health Canada to see the light that Empower Plus is a product that leaves freedom of choice for individuals to choose it if they see it's helping them. I have stacks of testimony this high in my office from individuals who have seen this product be beneficial to them. Now, I'm no expert in it, but I can tell you that I've read this compelling evidence, and for the life of me I can't understand why Health Canada is having such a difficult time allowing it to come across the border.

    In terms of 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 that. But I do know that freedom of choice of individuals to be able to choose a product for their own benefit is something 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 underway, 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 there was an application under the previous regulations for research. I was involved with those discussions. 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. 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 had to make an application to Health Canada for clinical trials, 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.

    That researcher has been in dialogue with us, and I suspect that will be undertaken shortly; it will 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 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 I'm not sure of. I think 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. Some people will say perhaps you should be able to prevent it, and in the pre-disease or in a preventive 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 into place with respect to the labelling.

  (1225)  

    The Chair: Miss 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 the NHP directorate?

    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 preventive versus the treatment of it. Obviously, all of us hope to be more preventive than just looking at treatment.

    I was interested in this Empower Plus, which you were speaking of. It almost seemed like the cycle was interrupted there somehow. They're trying to do the clinical research, but they didn't apply under the correct regulations or something, so it gets shut down. 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, the regulations weren't followed, or we really want to make sure 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, being in hospital or having psychiatric appointments, that ought to be a good thing, and we should be celebrating it 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 function, risk reduction, or treatment cure claims. The full range of claims are 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 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 there should be more information out there, and exactly the kinds of things Mr. Lunney was describing should be allowed. There are other people, not around this table perhaps, who we hear in consultation who 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 we have to consider. What we can 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: In terms of the trial itself, to be clear, the government's responsibility is to ensure that when consumers are being experimented on, it's done in a way that protects their health. And to be clear, when you used the term “shut down”, the trial wasn't so much shut down. What Health Canada 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 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.

  (1230)  

    Miss Deborah Grey: What's interesting is Empower Plus was shut down then. Why weren't those x people just allowed to continue, but no new guys allowed on, I wonder.

    Mr. Philip Waddington: With respect to Empower Plus, that's under investigation in the courts, 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, 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--

    A voice: It was tough.

    Mr. Philip Waddington: It was, but it was worked through to ensure that people could have access.

    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 we could not make decisions now on actions that were taken prior to that.

    Miss Deborah Grey: Thank you.

    The Chair: Mr. Ménard.

[Translation]

    Mr. Réal Ménard: There are some things I’m not sure I understand. What I understand is that Health Canada wouldn’t support the content of our colleague’s bill because it considers that natural health products are consumed for purposes that are more therapeutic than nutritional, and they think that natural health products should remain in the drug category. I think that’s your premise.

    Am I interpreting your position correctly by saying that?

[English]

    Mr. Philip Waddington: What you stated is correct, but it is not the entirety of why we believe 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 GMPs are in place, to show that the product hasn't been--

[Translation]

    Mr. Réal Ménard: I’ve got three questions. Why not go for a third category as, from what I believe I understood, the Standing Committee on Health recommended? What’s the difference between marketing, approval and labelling for the drug category and for the natural health product category? In what way can having the food category, in which natural health products will be included, be an information deficit for consumers and possibly a threat? That’s what I want to understand.

[English]

    Mr. Philip Waddington: All right.

[Translation]

    Mr. Réal Ménard: You’ll have to submit a document so that we can understand each other properly, because ultimately that’s what we’ll be expected to vote on. What is the process of approval, labelling and marketing when it’s a food product, when it’s a drug, and where’s the danger for Canadians and Quebeckers?

[English]

    Mr. Philip Waddington: If I caught your questions, I'll run through the three of them. Well, actually, you had four questions. You said you wanted something from....

    All the information around how a food comes to market, what is required under labelling, how a drug comes to market, and how a natural health product comes to market is 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 to go for a third category. That was for the first recommendation, I believe, and I believe the eighth one 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. So 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, 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.

    I believe you asked, what is the 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, echinacea--is in your product. You wouldn't have to state that on a food. 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 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 whatever is appropriate.

    The GMPs to require that the product is as it is in the bottle as it is on the label are 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 from clinical trials right through to traditional use, to ensure that appropriate--

  (1235)  

[Translation]

    Mr. Réal Ménard: I want to be sure of understanding properly. For natural health products, the producer must also submit the equivalent of a clinical monograph. To comply with Health Canada requirements, what does the producer of Echinacea have to submit as documentation today?

[English]

    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 that full range of standards of evidence.

    So 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, and 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 that 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.

    Mr. Boudria.

    Hon. Don Boudria: I have just a couple of questions.

    If I understood correctly, then, your method of doing this now--I don't mean to put words in your mouth, and you can tell me where it's wrong as I say it, please--is essentially by regulation, 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 the gist of it?

    Mr. Philip Waddington: Essentially, yes.

    Also, when we looked at it—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 it, so we proceededwith them first.

    Hon. Don Boudria: I understand how the government legislative process can be and is somewhat burdensome—as it has to be, perhaps. Not long ago I was the leader of the government, and the last step in reviewing a bill to ensure that it matches with the cabinet document is something the House leader does before any bill is introduced in the House. 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 it. 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.

    Does the way it has been done under regulations instead of legislative amendments stop you in any way from achieving the results wished for in that report of some time ago?

  (1240)  

    Mr. Philip Waddington: Do you mean the 52 recommendations from the Standing Committee on Health?

    Hon. Don Boudria: Yes. 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. The way in which we have approached it, save the recommendation of pursuing change at the level of the act, is exactly what we've achieved through these regulations.

    Hon. Don Boudria: Insofar as handling the issue of these particular products is concerned, it has been achieved by way of regulations. Is that what you're saying? In other words, if we replaced it with the legislation sought for in that report, it won't give you anything 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 want to clarify that what was sought in the 52 recommendations has been achieved, in my opinion, through the natural health product regulations.

    Hon. Don Boudria: All right. That's the information I'm looking for.

    So essentially, if we say we've not adopted that third category sought for in this report, 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: That's correct.

    Hon. Don Boudria: I see.

    I think that helps us to focus on what is the shortcoming, if there is one—I think 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, when all is said and done, isn't it?

    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. 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: He seems to agree.

    Mr. James Lunney: Madam Chair, I appreciate the indulgence of all committee members. 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 say first of all, though, Phil, the question is in response—and this is what Canadians are asking, because people who know these issues.... You and I know natural products probably better than most people in the room; that was a career for you and it was a career for me. I used them and I know the benefits of them. But for the response we're looking at here, and in what Health Canada has set up, the question really is, is it real? Have we really accomplished what was asked for by 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, be moving in different directions.

    When you say here you consulted broadly, that is absolutely true. There were extensive, exhaustive consultations; the health committee did that. But what is not clear, and what people in the industry are beginning to feel about this as they've looked at what's gazetted, is that it's an illusion and an actual betrayal of the process Canadians were led to expect.

    Without the third category.... I notice you put there that the committee also said we shouldn't delay; as important as regulation is, we shouldn't delay. What has the department done but take the legislative amendment, which would have put this in our proper category, and lump the legislative renewal of the Food and Drugs Act in with the Quarantine Act, the Radiation Emitting Devices Act, and the Hazardous Products Act as a whole new way to regulate health? “We'll look at all these acts together.” 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 have put them squarely under the drugs side of the equation.

    With all due respect, Mr. Waddington—Phil—when you said we couldn't have the good manufacturing practices, the regulations, and the 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. Along with them would go the good manufacturing practices, the office inspections, the quality controls that Canadians expect. We'd simply move it into a different culture, one that is more consistent with the low risk and the natural nature of these products.

    You said 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 or occasionally from doctors, thank goodness. Many are taking them because they want to be healthy. They're taking them without anybody's advice professionally because they want to be healthy.

    Health and disease form a continuum, as you and I would both recognize. To create an artificial branch here such that while in the preventive stage maybe you could take it if you want to, but once you have a disease you have to be regulated, is an artificial obstructionism that protects the interests of professionals more than it does those of the public. Recognizing that, if we have a natural product, surely we would want to make it available to people.

    I guess a final—

  (1245)  

    The Chair: Question?

    Mr. James Lunney: My question, yes.

    The regulations would be moved accordingly under that umbrella.

    I have to take exception to some of the comments that were 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, how Canadians would spell “betrayal”.

    Don, with all due respect, responding to the regulations by lumping the legislative renewal that was promised in with all of these other acts is a five-year or ten-year project, although we might hope it would be sooner. In the meantime, all of this other process would be going on, regulating and bringing companies.... It's quite clear 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 addressing other health concerns. That's what Canadians are very upset about, and it needs to be addressed, Phil.

    We're not against all of what's in the bill. There's a lot of good work done. We have Dr. Wong here, who sat on that transition team. It might be interesting to hear from him. He was one of the people who wrote these. We have Peter Chan here, who has a PhD in biochemistry, who sat on this regulatory committee. He's here; he sat on this board.

    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 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 the health committee, which is 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 in response to this.

    Mr. Philip Waddington: So is your question, why would legislative renewal take so long? I'll try to respond in a way that is appropriate.

  (1250)  

    Mr. James Lunney: It was more a comment than a question.

    Mr. Philip Waddington: I gathered that.

    The difficulties that you again correctly outline around the legislative process required to change things at the level of the act is exactly why we should undertake this kind of an approach at the level of the regulations. The acts all intertwine with one another in ways that are far more complicated than I would have originally envisioned, and 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 in which 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 food, 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 products foods, we've taken away their ability to make the claims, because those are what make them drugs.

    Mr. James Lunney: Well, that's where we disagree, Phil.

    Mr. Philip Waddington: If you look at the definitions, 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: Excuse me. I have one more questioner, and time is slipping away.

    Mr. Barrette.

[Translation]

    Mr. Gilbert Barrette: Thank you, Madam Chair.

    From what is known about people’s consumption and from the objective of what has been proposed, what would be your suggestion for modernizing regulations respecting the way in which people use natural products? To make this acceptable, what do you suggest to us?

[English]

    Mr. Philip Waddington: That's an excellent question.

    The regulations around natural health products are relatively new, and there is a learning process both within the government and within the industry as to how best to apply them. 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 are 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's going to come in on is comforting to me, because I think that means we have a relatively good balance between those two, which are on opposite sides of the scale.

    The next thing around the bill on the table is with respect to schedule A. I believe we should have a serious look at that, because I'm 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 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.

    So the next step I believe we should take with respect to schedule A is to have public consultations on that to make sure 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 that subject, I presume.

    Mr. Philip Waddington: This subject has two components. One is around natural health products. I believe the approach 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 is that 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 from the 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 on which we should go for public consultation. We've had an advisory group where we brought in stakeholders from media, from practitioners, from consumers, from special health care groups, and so on, 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 underway. 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 goes with the 53 recommendations. It relates to the question I was asking Mr. Lunney a while ago, and I ask 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, 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 we've undertaken.

  (1255)  

    The Chair: Thank you, Mr. Barrette.

    Madame Desjarlais.

    Mrs. Bev Desjarlais (Churchill, NDP): I want to ask you a question 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? Do you have the specifics as to exactly what other bills or 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 legislative renewal and 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 moves 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 and why it's included in that. I want the specifics of what other legislation it would affect, which is 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. I started four years ago. I don't know if that will give me any 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 that are 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, etc. There are a number of different acts that are being considered in unison. Section 3 and schedule A are 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 from the working group are going to the ADM and under which I envision she will probably undertake consultations on.

    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: My goodness, so is transportation safety.

    Mr. Philip Waddington: 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 taken 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, the Food and Drugs Act 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 the shaking this place is having right now would in fact be magnified and the ground would split.

    Madam Chair, I hope members will take this issue seriously. 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. 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 the health care of Canadians, will build healthier Canadians, and will reduce the costs and the burden on the system. I'm hoping that all members will assist in that process.

    Thank you, Madam Chair.

·  (1300)  

    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 week we agreed on the next four meetings, and I would like to remind you that Tuesday is the minister on estimates. So you have to dig out your estimates. On 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. I declare this meeting adjourned.