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EVIDENCE

[Recorded by Electronic Apparatus]

Thursday, June 15, 1995

.0910

[English]

The Chairman: Colleagues, if we can begin, today we are looking at the issue of rbST, and we have the pleasure of having Dr. Sol Gunner, director general, foods directorate, Health Canada; and Mario Simard, who is a senior counsel. Welcome. We always look forward to having lawyers here at the agriculture committee. They always seem to add a little bit of flavour to our committee. My wife's a lawyer, so I can say that.

Dr. Gunner, in the course of its review of rbST, the task force had asked Health Canada to do a study, a discussion paper, on the safety of rbST to animal and human health. Maybe at some point in your discussion we can talk about that.

Welcome, I understand you have a few opening words and then will be willing to answer some questions.

Dr. Sol Gunner (Director General, Foods Directorate, Department of Health): Thank you very much, Mr. Chairman.

As you indicated, I am here in the company of our senior legal counsel, Mr. Mario Simard. I have a very brief opening statement.

We are here in response to your invitation of June 7 to our minister, Minister Marleau; unfortunately, she couldn't attend. We're here to answer any questions that this committee may have with respect to rbST and any other issues that may arise.

Rather than make a lengthy opening state, we're here to respond, sir.

The Chairman: Thank you.

[Translation]

Mr. Daviault.

Mr. Daviault (Ahuntsic): Good morning, sirs. You surprise me a bit. Members of the task force told us that you were going to report on that part of our mandate that you are responsible for, and now you tell us that you are waiting for our questions.

Since the tabling of our committee's report, which set out the mandate of the task force, is there anything you have done? At least you could start with that.

[English]

Dr. Gunner: As we indicated at the last appearance before this committee, the role of Health Canada with respect to rbST is to review requests for its use. We have been carrying on a continuation of this review process, but the issue I would like to talk to this committee about, and in answer to the chairman's comments about preparing a status report, is that we have been continuing our evaluation of the request for rbST. As we indicated the previous time we appeared, rbST is considered a new drug, a new veterinary drug, and the evaluation of the data submitted by manufacturers is still ongoing.

As indicated in the appendix to the task force report the chairman alluded to, there is a range of other issues that were identified - health issues. These issues are also being reviewed in the context of the evaluation of rbST. I would draw the committee's attention to appendix 1 of the section dealing with animal and human health issues, part 2 of the task force report.

You will note there, Mr. Chairman and members of the committee, a range of issues that have been identified by respondents to the work of the task force - human safety issues, animal safety issues and a number of other issues.

In answer to your question, sir, we have been taking a look at these other issues, other health issues, that have been raised in the context of the deliberations, and that's in addition to the review process. So this really is what we have been doing, carrying out a continuation of the evaluation and considering also the new concerns.

.0915

[Translation]

Mr. Daviault: Out of a 350 page report, you take six pages to talk about questions you are studying, but you don't report on them. It is somewhat disappointing. I'd like for you to be more specific. How are these studies progressing? Is the list of questions currently under study all-inclusive?

My third question deals with a member of the task force who indicated, at our last meeting,

[English]

Health Canada has provided a human health clearance on rbST since 1990.

[Translation]

Is it true that the studies on human health were completed in 1990?

[English]

Dr. Gunner: You are obviously referring to one of the manufacturers who has indicated that a letter was received in 1990 that dealt with the human health issues.

Our comment is that the letter was valid at the date of its being sent to the manufacturer in question, but that does not mean that the issue of human health has received closure. As I indicated just a moment ago, there are a number of additional issues that have arisen since the time of the issuance of that letter, and the question with respect to human health as well as animal health has not been closed.

One of the reasons for your concerns with respect to information from Health Canada can be addressed simply by the fact that as public servants we are bound to uphold the law. The law in question deals with restriction on the availability of information subject to the law of Parliament in regard to the access to information, which prevents us from indicating the status of our review of confidential information.

I can summarize my response to your question by simply saying that the issue of health concerns has not received closure despite the letter that was sent at that time. Other issues are constantly being addressed as they emerge. Our concern is to fully address public health concerns as well as animal health concerns.

[Translation]

Mr. Daviault: What about the list of subjects you deal with in the six pages of the task force report, is it all-inclusive?

[English]

Dr. Gunner: To assist the task force, we had indicated that once the review of rbST has been concluded, in other words, that there was closure on the issue and a decision was made with respect to a notice of compliance, Health Canada would then be in a position to provide summary documents on all of the outstanding issues, including health issues.

The list that appears in appendix 2 is one that reflects concerns that were raised with the task force. There are other issues we are looking at within the context of our overall review, but until such time that we have concluded this we are not in a position, being restricted by access to information considerations, to provide this summary document, which we indicated would be forthcoming.

The Chairman: Dr. Gunner, you were talking about appendix 1. Is that the full list of issues you are looking at, then?

Dr. Gunner: Appendix 1 is the list of issues that are illustrative of the additional concerns that have arisen since the letter the hon. member indicated was issued. There are other concerns that we are looking at in the context of our reviews of the petitions for notice of compliance for rbST.

The Chairman: Do you have a list of those?

Dr. Gunner: No, I do not, sir.

The Chairman: Can you provide this committee with a list?

Dr. Gunner: I have indicated that the information with respect to submissions is considered proprietary.

The Chairman: I don't think I asked for submissions. I asked for a list of the issues that you are looking at.

Dr. Gunner: A lot of those issues are the subject of documentation from companies, and the mere indication of that list constitutes information that is considered proprietary.

.0920

The Chairman: You have your lawyer explain that to me. I don't understand how a committee asking for a list of issues that you're looking at...that you may have information provided by a company that you deal with would somehow be proprietary.

Mr. Mario Simard (Senior Counsel, Legal Services, Department of Health): The thing is that any information that would relate to what stage the review is at is confidential by law. That's why it cannot be revealed.

The Chairman: I don't think the committee asked for the status of the review. The committee asked for a list of those areas you're looking at.

Mr. Simard: I think that by giving you this list Health Canada would essentially be telling you about the concerns it is having and where it is at in its review.

Mr. Reed (Halton - Peel): Exactly.

The Chairman: Yes, I think you answered that one.

Mr. Reed: That's what we want.

Dr. Gunner: Unfortunately, Mr. Chairman, as a civil servant I am bound to uphold the law with respect to access to information, and the advice we've been given is that we can't release this.

[Translation]

Mr. Daviault: Do your studies consist in reviewing American studies or do you do your own? Secondly, do you carry out your own tests? Thirdly, is the manufacturing company you mentioned earlier involved in those studies and tests, as it was in the task force's report which was presented to us a few days ago?

[English]

Dr. Gunner: In general terms what is involved in the review and submission of data is that companies interested in having a new veterinary drug product approved provide the information upon which a decision is made. So in the case of bST submitted by any particular company they would generate the information based on tests that they have carried out, and it is incumbent upon Health Canada to review this in regard to the requirements under the food and drug regulations.

[Translation]

Mr. Daviault: I asked a specific question: Do you do your own studies or do you simply review the American studies? Do you carry out your own tests or is Monsanto involved? I understand that the manufacturer must always provide the original information but is Monsanto involved in the subsequent phases of your studies?

[English]

Dr. Gunner: In specific response to your questions, first, we do not necessarily look at American information. We look at information that's been submitted to us. Secondly, as with any veterinary drug the responsibility for carrying out the tests lie with the manufacturer. Health Canada does not itself carry out studies in support of drugs to be used by private companies.

[Translation]

Mr. Daviault: They are going to use the product in the end...

Dr. Gunner: He has a small toy, a small cow.

[English]

Finally, with respect to the Monsanto issue that you mentioned, as was indicated in the previous report of this committee, Monsanto is one of the companies interested in receiving a notice of compliance for their product.

[Translation]

Mr. Daviault: So, you rely on tests carried out by Monsanto?

[English]

Dr. Gunner: We rely on tests carried out by this company as the critical element in the review process for their product.

[Translation]

Mr. Daviault: Did you work with European researchers or did you analyze European studies that conclude that there is insufficient date on the safety of that product and that the U.S. studies lack rigour in that regard?

[English]

Dr. Gunner: We rely in our review primarily on Monsanto with respect to their product, but as I already indicated, there are other concerns that come up and are listed in the appendix that impact on the issues.

.0925

With respect to foreign research - European and other countries - our scientists and our personnel who are involved in the review process are aware and take into account literature on a worldwide basis. So they are taking into account the reports that you've mentioned, and other studies. In fact, members of our staff have been part of international committees studying bST. Research from other venues is taken into account at arriving at an overall conclusion, but the prime database with respect to specific products is the data that is generated by the company for that product.

You must understand that some of these bST products have subtle differences that don't impact on the efficacy or the intended use, but these subtle differences are taken into account in the evaluation that's carried out for health and safety and efficacy.

Mr. Easter (Malpeque): Mr. Chairman, as a point of information, I wasn't here the other day when the Morrissey committee, the task force on rbST, was here. I do have a -

The Chairman: Where were you?

Mr. Easter: I was at a meeting in Washington.

It would appear that at that meeting Dr. Morrissey, chairman of the task force, indicated in response to a question from Lyle Vanclief that the principal reason for the European Union not allowing the use of rbST is for social and economic reasons, not for reasons concerning either human or animal health. I'd like to table with this committee a copy of the cancellation of the decision, dated December 20, 1994, from the official journal of the European Communities, which states in part the following:

I just want the record to be clear, and there's the document. It is not, as Dr. Morrissey said, for economic and social reasons only. That is a factor, but it's also with regard to their concerns of the incidents of mastitis.

The Chairman: Thank you, Mr. Easter. That's a nice point of information, but it's not a point of order. But we can table that document.

Mr. Easter: I don't care as long as it gets in the record, Mr. Chairman.

In the previous discussion, Mr. Gunner, you indicated that there is some involvement with other countries in terms of their concerns. I raise this question in part based on the information I just tabled. I'm wondering how far the investigation of Health Canada goes in terms of other countries' concerns with the use of the same product in their country, on the health side of the issue.

Dr. Gunner: The requirements under the food and drug regulations are quite specific in that the responsibility for the review of these new drug applications rests with Health Canada. Our scientists, our evaluators, have knowledge of other individuals who are dealing in other countries, and there is contact. There is no statutory requirement to do this, but in order to get as complete a picture as possible, there is contact with counterparts in other countries and through venues such as international expert committees. For example, the World Health Organization/Food and Agriculture Organization has an expert group that reviewed bST some time ago. One of our scientists who is responsible for certain aspects of the evaluation was a member of that committee.

It's through these kinds of contacts that knowledge of what goes on in other countries is established and maintained. It's a question, as I indicated in my reply to the previous question, of monitoring international literature. We monitor what's going on in other governments, and it's part of the global review package.

.0930

Mr. Easter: Also, the question that was raised previously, and for which you can't provide information, is part of the problem. The last time Health Canada was before this committee - over a year ago, I think - we did raise concerns about the neutrality and the independence of research, and that we're in fact depending on the very companies that are promoting this product, on their research, and doing analysis of that.

I think you're well aware that this is a fairly broad, controversial issue in the public domain. It certainly will have severe implications on primary producers if approval should be granted and the consumption of milk should fall, and it will also have severe implications on our supply management system.

In light of that - I know there are only certain things you can do within Health Canada - what are the options that are available to the minister in terms of disallowing this product into Canada? What are the options available? Can the minister, if she so decides, require a test to accompany this product before it's been granted approval? Are any of those options available?

Dr. Gunner: Mr. Easter, could you clarify what you mean by a test?

Mr. Easter: Coming from the National Dairy Council, there is a proposal that because of the concern over the use of this product by the Canadian public, we might have to go to a labelling system. Maybe we'd have to go to a dual-milk system, which would be extremely inefficient.

They suggest that those who use the products and the pharmaceutical companies that sell the product, rather than the general transportation system as a whole, should cover that cost. Before you could do that, we would first require a test. Could one of the conditions of approval be that there would be a test required? I'm asking whether the minister has that authority. What are the options available to us as a government?

Dr. Gunner: The regulations are quite clear on what happens with regard to new drug submissions in food and drug regulation C-08004. If I may, Mr. Chairman, I'll read it to put it into the record:

The minister shall issue a notice of compliance. There's no discretion if it meets the requirements. If that submission does not comply with requirements - and I won't quote the sections - the minister shall, with no discretion, notify the manufacturer that the submission or supplement does not so comply.

There is a caveat that says:

So with regard to the specific options on a request for a notice of compliance, the minister can either grant the notice if all requirements are considered to have been met or indicate to the manufacturer that this is not the case. The manufacturer still has an option to supply further information.

With respect to conditions of sale, I think there is some leeway there. For example, as a result of the evaluation, the evaluators can consider that drugs fall into certain classes; for example, a prescription drug or a non-prescription drug. Depending on the circumstances and the nature of the drug, this can be determined to be a condition of sale, if you will.

With regard to your question about tests, I'm not sure whether this is possible within the context of conditions for sale, but it's certainly an area that could be explored.

Mr. Easter: When the chair of the task force was here, he had indicated that at least three tests for bST had been examined and a fourth is currently being examined. Now I don't know whether Health Canada has looked at those or not.

.0935

My reason, Mr. Chairman, for going down this line of questioning is to be blunt about it, as a member of parliament and as a member of the government. I find ourselves in what feels like an impossible position. We have only one group seemingly interested in bringing this product into Canadian society, and that's the pharmaceutical companies.

When I asked the chair.... They're shaking heads over there. The Dairy Farmers of Canada have a major resolution opposing it, although the chairman of Dairy Farmers of Canada has been less than forthright in finding such a resolution.

The Chairman: Final question, Mr. Easter.

Mr. Easter: In any event, I want to try to find out what options are available to us as a government to do what the public wants us to do, not just what the pharmaceutical industry seems to want us to do. Are there any other options available to us?

Dr. Gunner: As far as Health Canada is concerned, we have very few options, sir. We either issue or not issue a notice of compliance and put conditions on sale as I've described, but we -

Mr. Easter: [Inaudible-Editor]... anything at the cabinet level?

Dr. Gunner: I'm not qualified to comment on that, sir.

The Chairman: Mr. Benoit.

Mr. Benoit (Vegreville): I'd first like to make some comments on Mr. Easter's statement, starting with the statement that only one group is interested in getting this product on the market. That is nonsense.

I've heard from a lot of people who want this product on the market. In this room today, we have dairy farmers who want the product on the market, we have veterinarians who want the product on the market, and we have Dr. Louise Sellars - at the back with a baby - who wants the product on the market. There are an awful lot of people who want the product on the market, so let's not distort that.

I'd like to comment on Mr. Easter's suggestion that consumption will drop if this product comes on the market. Of course, he was saying that last March and April in our committee meetings, and he is saying that consumption would drop in the United States. In fact, it increased over the first full year of use.

The Chairman: Mr. Benoit, if we could ask questions so the witnesses could -

Mr. Benoit: Yes, I'm getting to the questions. I have just a few leading statements.

The Chairman: We could debate this for quite a while. I think today our purpose is to -

Mr. Benoit: I'm leading into it, Mr. Chairman. We're not going to invoke closure at committee, are we?

The Chairman: Remember, it's Robert's Rules of Order.

Mr. Benoit: Mr. Easter has suggested there will be or is an increase of mastitis with cows that use bST. The studies just don't indicate that, so I'd like to start by making those comments.

I'd like Dr. Gunner to comment on the Reform Party's statement on agriculture and food biotechnology and how we believe biotechnological products should be dealt with by the regulatory agencies. I'll just read it. It's just three short paragraphs, and I'd like you to comment on this after:

I'd just like Dr. Gunner to comment on whether he agrees with that as a statement of how a new product should be introduced into the marketplace.

Dr. Gunner: As a civil servant I have to be neutral, and you've indicated a statement from the Reform Party. Notwithstanding that, sir, as an individual, I would support the tenets there without political partisanship. Health Canada has continually stated that the review process is based on science and that science will be the sole determinant.

.0940

Other variables, such as marketplace, political processes, and questions of moratoria are completely not within the realm of how we do business. We base the entire review on science. In that context, I can endorse personally the principles you've indicated aside from what political party they do emanate from.

Mr. Benoit: Can you assure me - and I think there are a lot of people that need assurance of this - that it isn't in fact for political reasons that Health Canada has not presented its report on this product and its approval for this product?

Dr. Gunner: I can assure you that the reason we have not done so is that we have not concluded our review, and the review, as I indicated, is based on a scientific examination. That review has not been concluded, and that is the sole and principal reason that we have not been able to address the requests of the task force for a full report on health and safety issues or to be more forthcoming with any other information. The review has not been concluded, sir.

Mr. Benoit: The fact that the review hasn't been concluded has nothing to do with political interference?

Dr. Gunner: That is correct.

Mr. Benoit: Thank you, Doctor. I think there's a lot of concern that the reason this report hasn't been put forth - and it's from both sides, people on both sides of the issue - is that it is political influence that has held it up. I really appreciate your -

The Chairman: Mr. Benoit, I'm sorry, do you have proof of that, or is that just...?

Mr. Benoit: I said there's a lot of concern from people on both sides of this issue that it is political interference that is holding this report up.

The Chairman: That would be very valuable information if -

Mr. Benoit: I don't think we need an awful lot of proof of that, Mr. Chairman. I've heard it a lot myself, and I would imagine any others involved have heard that. I believe there are other MPs who have expressed that concern.

So I do appreciate your assurance, and I certainly hope that is the case, because it's critical that the regulatory bodies of government are working without political influence and that they do make the decisions based on the best scientific information available. It's not only that it happens in fact, but also that it appears to happen. It is very important from the point of view of getting products on the market that are safe and not damaging business that depends on these products and puts a lot of money into these products.

It's critical. I do appreciate your assurance, and I certainly hope we get the report soon. It would very damaging to the credibility of Health Canada or any regulatory agency if it were determined that there was political influence.

Mr. Reed: You can see it's pretty obvious that the dangerous path we often tread in committees is the delivery of uncorroborated hearsay. One of the challenges before us is to deliver hard evidence, not to deliver our assessment of the feelings of things that are told to us.

I suppose when you mention the subtle differences between products, Doctor, would I be in the ballpark if I said it might be the difference between Aureomycin and Terramycin - that kind of subtle difference - a product that does the same thing but it's perhaps on a different carrier, a different radical, and -

Dr. Gunner: Without going into the specifics, Mr. Reed, what I'm talking about are subtle differences in the molecular structure of these products. As you know, they're genetically engineered products, and there are subtle differences in the various products as manufactured by different companies that do not impact on the reason for their use - that is, the increased production of milk. But there are these subtle differences.

.0945

Mr. Reed: I asked that question because I have a bit of passing familiarity with those two antibiotics, and the fact is that everybody knows what the differences are. It's public information. So there's nothing commercially confidential about it.

The dilemma we face here, of course, is how we can make an intelligent recommendation to the minister. After all, we're the elected people. We have to take it beyond the scientific area, because we represent people and citizens. How can we come to an intelligent decision if we don't know the parameters - if the parameters are considered commercially confidential and can't be released, when in fact it's not transparent? This is a dilemma, Mr. Chairman, that I think we're concerned with. Perhaps some of the parameters you use are spelled out in the act. I don't know.

Let me ask you a final question. Is the worldwide literature that you refer to, depend on, and analyse commercially confidential?

Dr. Gunner: A lot of it is in the public domain, so that is available. There have been discussions in the publicly available literature about some of the subtle differences that I'm describing, without attributing to various products, but there is an indication of that type of information in the literature.

The last time we were here, sir, we tabled a list of scientific references that contain some of this, and I can resubmit this and draw it to your attention with regard to some of these differences, if you'd like.

Mr. Reed: It's the parameters we don't have that cause me the concern, because I think when we do come to a conclusion, we want to come to the right conclusion.

Thank you, Mr. Chairman.

Mrs. Cowling (Dauphin - Swan River): Dr. Gunner, one of the questions I raised with officials who were before the committee only a week ago was how many countries are using bST. I believe the response we have been getting is that about 36 countries are using that.

I have some information that indicates that out of four calls to embassies, two indicated that bST is not approved. One was in, I believe, Czechoslovakia, and the other in Russia. One explained that only four farms in the entire country of Zimbabwe are using it, and one of the embassies in South Africa explained that there is approval of 3% of the farmers. Is that true, or do you have any supporting documentation as to how many countries are in fact using it?

Dr. Gunner: I would hesitate to give you a definitive answer, but I think the type of information you are quoting sounds reasonable. I don't have anything to supplement that officially, to put the stamp of approval that such and such a country.... I just don't have that type of information.

Mrs. Cowling: Would it be possible to have that information before the committee so that -

Dr. Gunner: What we could do is survey again through our contacts.

The reason I'm hesitant is that things change in different countries, and I wouldn't want to state a position on behalf of a country without checking with the embassy.

We'd actually go through the same process that you've gone through. We would have our researchers contact the embassies to affirm positions or, for example, the position of the European Union in order to make sure any statements are accurate. But I don't have the type of data I could vouch for with me.

Mr. Vanclief (Prince Edward - Hastings): To the two gentlemen who are with us this morning, I apologize for not being here at the start, and maybe these questions have been answered.

.0950

We see from time to time figures that there have been in the neighbourhood of 1,500 scientific studies that have been done throughout the world, or pieces of information provided, as to the rbST and as to safety. Have there been any additional studies, for example, in the last six to ten months that have come forward from the scientific community that were not there before?

Dr. Gunner: I believe there are some studies, although I can't name them for you. As was indicated before you arrived, Mr. Vanclief, the primary source of evidence that is reviewed by Health Canada with respect to these requests for notices of compliance pertains to the information that was submitted by the companies for their specific product, taking into account the subtleties and the various differences between the products. So the information that was generated by the companies remains the primary source. Other studies that appear in the literature - and there are always studies appearing - are taken into account as they become available.

Mr. Vanclief: Okay. Maybe you answered this. If so, I apologize. When is the last time Health Canada asked the submitting companies to provide more information? How long ago was the last request?

Dr. Gunner: Without breaching any confidentiality, dialogue continues between the evaluators and the companies to clarify certain aspects and to discuss a whole range of issues that may emanate. I don't have a date, because we have more than one company that's involved. It's a matter of public record before this committee. I can't tell you exactly which date clarification or information was discussed. But suffice it to say that discussions are ongoing with companies as the evaluation process proceeds.

Mr. Vanclief: Maybe I could narrow it down a bit more. As most of us are somewhat familiar with another area in agriculture, and if I could use the word ``pesticides''... From time to time we hear, for example, that a company applying for registration or an application is being asked for more information on residue. Has there been any request for...?

I can't define it, but I think you know what I'm getting at. Has there been any request in the last number of months to either one of the registrants, other than dialogue? Yes, dialogue goes on back and forth. Has there been any request for any major new input - I'm not asking for what it might have been - to either one of the two, I think, applicants in this case?

Dr. Gunner: The precise answer is yes, there have been requests for additional information. But I am not at liberty to divulge that, sir.

Mr. Vanclief: Okay. I understand that.

There's some debate, gentlemen, as to why the moratorium in the European Union has been extended. There's some understanding or information that many of the countries - or a number of countries, at least - in the European Union have accepted rbST as far as its health and safety are concerned, but that the European Parliament has extended the moratorium on the use of rbST for social and economic reasons. What is the situation, in your view? Why is the moratorium still in place, and why was it extended in the European Union?

Dr. Gunner: I can't really speak for the European Union, Mr. Vanclief.

Mr. Vanclief: Thank you.

[Translation]

Mr. Daviault: Point of order, Mr. Chairman.

My colleague advised you earlier that he would let me ask questions when his turn came around again. However, it now seems that you want to apply a rule according to which each member of the committee would be allowed to speak on the first round and come back for a second round. I think that the letter and spirit of the Standing Orders are meant to facilitate the work of the Opposition. Based on my experience with most committees I have sat on, there should be time allocated for the official opposition, time allocated for the government, time allocated for the third party, time allocated for the government and so on.

.0955

I think we should keep to the spirit of the Standing Orders so that we can go on with our questions.

Therefore, I challenge the ruling of the chair.

[English]

The Chairman: Well, Mr. Daviault, I think I already told you what my decision is on that. The opposition has six members on this committee. If the opposition members wish to show up and ask questions, that's fine. But if they don't decide to show up and don't ask questions, their time will obviously have to be picked up on the second round by their members.

Mr. Daviault, we have one more government member, then we'll be getting into the second round. Do you want to spend the time of this committee debating something silly like this before one government member asks a question and you get a shot at a second round?

[Translation]

Mr. Daviault: No. Besides, I was polite enough to let the parliamentary secretary put his question, but I think nonetheless that your ruling is wrong. We must follow the rules you set, but your ruling runs counter to the spirit of the Standing Orders.

[English]

The Chairman: Mr. Steckle.

Mr. Steckle (Huron - Bruce): Mr. Chairman and Dr. Gunner, I apologize for being somewhat late in coming to this meeting.

I want to first preface my questions with a comment, and it has to do with the efficacy part of it. We're dealing this morning, of course, with health. At a meeting earlier this week we spoke on other issues. Some of the questions seemed to centre around health. I think that's the general focus as we come down to the crunch in terms of our timelines.

A number of years ago, back in the late 1960s, thalidomide came onto the market. Of course I'm using this as a lead-in on the efficacy part of it. Thalidomide did exactly what they said it would do. It provided relief for those people who were using it for the intended purposes. The desired results were achieved. But there were side effects, which were not realized until some time later and to the sorrow of many people.

Silicone implants, another product, the desired results were achieved - mammary implants. We had a number of years ago the Dalkon shield; also the desired results were achieved with these products.

So if we want to look at efficacy and we want to look at efficacy in terms of how it relates to this product of bST, I don't think there's any doubt. This leads me to the point of question. Is efficacy really as important as we have thought it might be, or should we be looking at the consequences or the benefits of this? Obviously the benefits enter into the efficacy side of it. I think we have to look beyond and into the future, and of course we haven't lived the future so it's pretty hard to do that.

I'll go back to what the parliamentary secretary was questioning this morning in terms of the kind of clearances that have been given, the kinds of things that are being looked at currently when in fact in 1990 basically we sort of terminated the review. In response to a question that I asked on Tuesday, basically there have been no comments or requests from Health Canada for further human health studies since 1990. That is not to say that there may not have been papers or that there may not have been questions raised on that issue.

In 1991 the Council on Scientific Affairs of the American Medical Association stated:

Dr. Gunner: Thank you. I don't know if you were here when this issue of the letter issued to Monsanto was discussed. You used the words, sir, ``terminated the review''. That is not correct.

The company in question received a letter indicating that health concerns had reached a certain point and that there weren't any at that time. That does not, as I indicated previously, indicate closure on the issue of health and safety.

.1000

As science marches on, there have been additional concerns raised. The IGF-1 is one that has returned to the forefront. So that letter, which was issued at the time, represents the status at that time. The entire issue of bST has not received closure. There has been no decision taken on whether or not a notice of compliance will be issued. So I would like to correct the impression - and using your words - the review on health has not been terminated. The review of bST per se as an issue is still ongoing. Health and safety concerns are paramount.

So we're not only dealing with the question of efficacy, health and safety in animals, but health and safety of humans. When we indicated that the review is ongoing, that is precisely the status. We will be taking into account in the ongoing review and are, in fact, taking into account concerns such as you've raised.

I also indicated - and as I say, I'm not sure you were here at the time - in appendix 1 of the task force report there is a whole series of health and safety issues that were raised with the members of the task force. These form part and parcel of the areas that are currently being re-examined.

I trust I have, in a clear way, clarified what your concerns relate to.

Mr. Steckle: We're basically being told that once we have passage of this by Health...and it's something that has been accepted as humanly safe, I guess, for some time. Now, why is it that we cannot get any further data? Why is this data not being released? Why do we have to wait until after it has already been passed and the usage is in place? It's then that we get the information. Should it not be the reverse?

Dr. Gunner: Again, this was alluded to. We're constrained by access to information legislation in terms of what we can or cannot reveal, sir. As civil servants, we are constrained by this act of Parliament.

Mr. Steckle: Having just said that, and knowing you are constrained, should there be changes in legislation? When we look at the whole health question, are we not somehow, by legislation, denying the Canadian public a right to something that may or may not be beneficial or detrimental to them?

Dr. Gunner: Mr. Chairman, if I can answer that, that's a question for Parliament to decide.

The Chairman: Dr. Gunner, again, I'm trying to understand how this committee's request for the areas you're studying can be protected under the access to information. I mean, I'm reading section 20 of the access and it talks about trade secrets, financial, commercial, scientific or technical information. It talks about information the disclosure of which could reasonably be expected to result in material or financial loss or gain to...could reasonably be expected to interfere with contract negotiations with third parties. I don't see anywhere in here how this would be proprietary information.

Dr. Gunner: Perhaps I can illustrate. For example, suppose we indicated to the committee that one company was being questioned in regard to a specific safety issue, just listing that. There are competitors who can understand the magnitude of the concern and perhaps realize that in order to answer that question a company would have to spend a year in an additional study to generate the information. The knowledge that it would take that time to generate a dossier of information to satisfy the concern that was being raised, is prejudicial information to the company in question. It's covered under section 20.

So, as we indicated previously, the mere listing of an area of concern to the Government of Canada indicates valuable information with respect to the status of a petitioner's data base, valuable information that could be detrimental to the company and beneficial to other companies. That is covered in our interpretation of how we deal with access to information requirements.

I'm sympathetic to the committee's request for data, but as we explained, we're constrained as civil servants by the requirements of this law.

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Mr. Steckle: I'm simply doing a clarification, because I think Canadians have a right to know. It's not that we're asking the pharmaceuticals to give trade secrets away. But I think we ought to be aware and apprised of the status, of the current level of science and where that's at, and how that has been researched, so the Canadian people can feel well assured that once a decision is made it has been done on a basis of scientific evaluation.

Dr. Gunner: Mr. Chairman, perhaps I might clarify. One of the commitments that Health Canada made to the task force was to supply just such documentation, once a decision had been reached on whether or not a notice of compliance would be issued. To take the point further, should there be a decision that a notice of compliance would be issued, then a complete dossier of information addressing the concerns raised in the task force report would be issued by Health Canada. We have undertaken such a commitment. But until such time as the review is complete, as I say, we're constrained by access to information.

Just as an observation, I deal with many access to information requests on a daily basis. The amount of information we actually provide is quite considerable. The only constraint is proprietary information.

If you're asking for an observation on how it works, in my experience it works rather well in terms of the information we do provide to those who request it. But as I say, these constraints - we have to live within those requirements.

Mr. Steckle: I'll pass until the next round.

The Chairman: Mr. Daviault, we have five-minute rounds.

[Translation]

Mr. Daviault: I won't question your rules again; I'll bring this before the proper authorities. That is your way of doing things and as I am not a permanent member of this Committee, I won't give you a hard time. However, I find your way of doing things very peculiar since the standing Orders - at least according to their spirit - , would have you allot sufficient time to the Opposition. There are 53 of us; we try to do good work and your rules work against us.

Sirs, I would like to ask you a question about substance, but I'm reluctant to do so because you don't seem to be able to answer such questions.

[English]

In 1991 the Council on Scientific Affairs of the American Medical Association stated:

La même année, the U.S. National Institutes of Health called for further research to determine the acute and chronic local action of IGF-1.

[Translation]

In 1992, the Royal Society of Medicine was also calling for further studies on IGF-1. However, when we last met, a member of a task force representing the company you rely on for your tests, told us this:

[English]

[Translation]

Is it true that since 1992 you have requested no additional comment or study from your main information provider, Monsanto?

[English]

Dr. Gunner: Thank you.

As I indicated in response to Mr. Vanclief's question with respect to additional information, we have asked for additional information from companies. But I'm not at liberty to indicate to you the nature of this information.

[Translation]

Mr. Daviault: The Food and Drug Administration got 800 complaints of sickness in cows in the United States. Did you study that aspect of the question?

[English]

Dr. Gunner: Questions regarding animal health are under review as part of the review process, sir.

Mr. Daviault: But you can't tell us exactly what...

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[Translation]

In a report on somatotropine from the Research Branch of the Library of Parliament dated June 9, 1995, one can read on page 3:

[English]

The Chairman: Please slow down for the interpreters.

[Translation]

Mr. Daviault: I want to be able to ask my last question. If you tell me that I have 30 seconds left, if you want to be a stickler for the rules, I will have to be quick.

[English]

The Chairman: Well, then -

Mr. Daviault: I had a question.

The Chairman: Make it quick.

[Translation]

Mr. Daviault: Is the use, sale and importation of recombinant bovine somatotropin, rbST, prohibited in Canada?

[English]

Dr. Gunner: Until the drug has been approved, the sale is illegal. Importation for sale is illegal except under very specified circumstances, but the use is not prohibited.

Mr. Easter: In this area of what information is available and what isn't, I can understand that... certainly I don't think any of us would even request information that is going to put one company at disadvantage to another. But in light of that, I'm wondering if the restriction is under protecting the information of companies in terms of privacy laws, or is it under access to information? I ask this so I can delve further into it.

Dr. Gunner: My understanding, sir, is that it's primarily under access to information, section 20.

Mr. Easter: You said that the questions regarding animal health are under review. I just want to correct the record to Mr. Benoit's statement. I never said bST causes mastitis. I've been very cautious on that point. I said it will increase stress in animals. There is a disclaimer relative to mastitis, sold with the product in the United States.

In terms of your investigation of animal health, will you still depend on the companies' information? I have a press release here from the Wisconsin Farmers Union. It says:

Given that information, can Health Canada, through the FDA, investigate their findings on that? Or do you still just depend on the information provided by the pharmaceutical companies in this case?

Dr. Gunner: We rely on information from both sources. We expect the companies to be forthright with us in indicating both the positive attributes they may see for these these commodities as well as any negative reports. We also have contacts with sister regulatory agencies in terms of discussing a whole range of issues.

Mr. Easter, one of the problems is that other governments are also constrained in what they can divulge - it's a touchy area - even to sister regulatory agencies. So one has to rely on what can be achieved within the legal constraints operative in other countries. But we do have contacts with other agencies.

The short answer to your question is both company information - and we expect them to be forthright - as well as contact with other agencies. In fact, other agencies will issue updates indicating a status report, etc., and they will divulge this information as a matter of public record.

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Mr. Easter: What happens if you find out they are not forthright? There's a lot of varying views on this issue, and at the end of the day, regardless of the decision, I want to have and I want Canadians to have confidence in our regulatory system. I think we have to assure Canadians in general and farmers in particular in this case, and consumers, that Health Canada is in fact doing the job to the utmost.

Dr. Gunner: This question came up, as you will recall, sir, in the previous session of this committee when we indicated that the prime source of information was data generated by companies and the question of trust at that time came up in terms of questioning by the committee.

My observation would be that it would be sheer folly for companies not to be completely forthright with government agencies, particularly on issues where there is such a series of concerns from various sectors with regard to potential products. We have to rely on the companies' information, the database upon which to make a decision in the first instance, and we have to rely on their honesty in providing us with updates, both positive and negative, with regard to their products.

Like you, I'd like to be assured and I'd like the assurance to be conveyed that Health Canada is doing the best it can considering the constraints we're under, but we have to rely in the first instance on the companies in question for this and other products we review.

Mr. Easter: How am I for time?

The Chairman: That's it. Thank you.

Dr. Gunner, under annex F or schedule F of the Food and Drugs Act, we see listed here somatotropin. Is that the same as rbST, and if it is, why?

Dr. Gunner: Our consideration of that, sir, is that it is a term that covers somatotropins generally, including bST, and that puts constraints on its importation. Schedule F drugs can only be imported by licensed practioners, manufacturers, registered pharmacists or visitors from other countries. So the classification of rbST under the general term somatotropins has an impact in terms of importation.

The Chairman: Mr. Benoit.

Mr. Benoit: I don't want this product to go on the market if it's not safe, nor do I want it held off if it is safe. It seems to me that several members of Parliament have either directly or indirectly questioned the regulatory process that Health Canada uses in the approval process for products.

I would like to ask you, Doctor, if you believe the process that is in place now within Health Canada is a process that will ensure to a reasonable probability level that a product is safe. Is the process good enough?

Dr. Gunner: I feel it is, sir. I feel it is.

Mr. Benoit: There has been questioning of the process wherein the company that has developed the product and is trying to get approval provides much of the information that is used in the approval process, and you have explained it would be to the company's detriment if ever they were found to be giving inaccurate information. If you look at it, it would probably lead to the bankruptcy of the company, I believe. It would be so difficult for them to ever again have a product approved and the backlash would be incredible.

I guess you've stated already that you're not particularly concerned that the companies do provide a large portion of the information.

Dr. Gunner: Just to illustrate the case, a number of years ago in the United States an investigation revealed that a testing company had fraudulently misrepresented results of tests in support of a number of products that regulatory agencies approved. The impact of that was so devastating that officers of the company were prosecuted. Criminal prosecutions ensued and they were sent to jail, I believe. This had severe repercussions across all the industry as one example of what can go awry.

We have to rely on companies in terms of generation of data, because we're dealing with thousands of products, new drugs, new medical devices, new pesticides, new food additives. The government does not have the resources to generate tests on its own for all these products. Ultimately benefits accrue to various companies, so they are responsible under this system for the generation of information.

.1020

Mr. Benoit: What's the record of Health Canada in terms of approving products that have proven to be unsafe?

Dr. Gunner: I think the record will show that in very few cases Health Canada has made the right decision, and in those cases it's the result of subsequent research, which can happen at any time. I may say should an NOC be granted for any product and should evidence come to light subsequently concerning adverse health effects, that NOC can be withdrawn.

In regard to Health Canada's record, I think it stands on its merits in terms of making decisions based on the best science of the time. If other scientific findings come to the fore that indicate there is a potential health concern, then remedial action, including, in the cases we're talking about here, revocation of a notice of compliance, can be taken.

Mr. Benoit: What circumstances would have to be in place for Health Canada to be able to give a 100% guarantee that a product is safe?

Dr. Gunner: I don't think we can ever give a 100% guarantee on anything.

Mr. Benoit: The only way to get a 100% guarantee would be to approve no new products.

Is human health the primary area being studied by Health Canada? Is that the reason the approval is being held up on this product? Is it the primary area of concern?

Dr. Gunner: We are looking at all areas - human, animal and efficacy as well.

Mr. Benoit: When you're looking at the human health area, you look at studies that have been done in the United States by the company. I understand there have been studies done by Monsanto in this case where humans have been using milk produced from cows that have been treated with bST. Is that the case, first of all?

Dr. Gunner: I can't comment on that.

Mr. Benoit: You can't even comment on a broad question like that?

Milk produced from cows that have been treated with rbST has been used in Mexico for some time. Is that the case? Are you aware of where it has been used around the world?

Dr. Gunner: That question was raised by the other hon. member. It is being used in other countries, but I cannot confirm, as I sit here, what countries.

Mr. Benoit: Okay. What's the longest period of time this product has been used in another country where people have been consuming the milk?

Dr. Gunner: I think it's a matter of years, sir, but I can't tell you the precise timeframe.

Mr. Benoit: I think that would be very interesting to know - how many years it's been used and if there is testing done in those countries on people who have been using the milk. It would probably be the general population.

Dr. Gunner: We will attempt to get information to you through the chair on the length of time and the approval in other countries.

Mr. Benoit: And if there's any indication in any country that there are health problems to either humans or cows, I would like that information.

Dr. Gunner: It has already been stated that adverse reactions have been reported in certain subsets of cattle. There are also reports that it's advantageous in those areas, and these reports are a matter of public record in the specific country.

Bear in mind certain agricultural practices take place there and perhaps there are different temperature conditions. So those reports have to be taken in the context of a whole range of other factors. These are a matter of public record, as has already been stated.

We will endeavour to find for you the length of time that bST has been used in certain countries, if that is of assistance to you.

Mr. Benoit: Yes, I'd appreciate that. Thank you.

Mr. Steckle: Something that was just drawn to my attention this morning is that estrogen is good for the heart but raises the risk of cancer. I think this goes back to the whole efficacy question. It has to do with a test that's been done for some time on 122,000 nurses.

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Estrogen, of course, is a natural hormone used by menopausal women to deal with various problems. Tests are now showing estrogen not only does just the normal things we think it does for women; it has side effects. Now it's found that 30% to 40% of the women are likely to have a greater chance of contracting breast cancer. I think this substantiates again the point I was making this morning.

The response we just heard was we really don't know how many years there has been experience in using this, so we really don't have a long history of people using milk from cows treated with rbST. Have we gone far enough into the future to really know whether or not this is going to have side effects? Or do we accept the fact that it probably won't cause side effects in the future?

Dr. Gunner: When we carry out a review we look at all the issues - public health issues, animal health issues, etc. Based on the results of our review, we make a determination as to the status of a drug.

For example, if there may be certain side effects, that can determine the status of the drug in question. It can be given prescription status to be administered by a licensed veterinarian, etc. If it's a drug about which relatively few concerns arise, that will determine its status as a non-prescription drug.

So with regard to the side effects you mention, those are taken into account in determining the status of the drug once a decision is made on a notice of compliance.

With regard to the future - and this is in response also to the previous question - science continues to march on. There are always new studies being generated. As the results of that scientific information become available, if they impact on any decision on approvals, they're taken into account.

It's not too easy to predict the future. We have to base our decision on the information that's currently available. But as I indicated previously, should any evidence come to light after a decision has been made that there are adverse effects, on the basis of that information a decision can be taken to revoke at any time a notice of compliance.

Mr. Steckle: This morning you said you thought the regulatory processes were adequate. On March 3, I believe it was, you had something to say to this committee.

I'd better start at the beginning. The question had to do with whether the processes were adequate and whether we were doing the right kinds of things. Your comment was, and I quote: ``First of all, we have to take the results in good faith.'' I think we would agree with that.

Then you went on to say: ``Whether this is troubling to the committee, it is certainly troubling to regulatory agencies as well.'' I'm just wondering whether you still feel that way or whether you have had a change in thought on that issue.

Dr. Gunner: I'm talking about process generally. I still come back to the view that we have to rely on the integrity of the companies in question. It has been indicated here it would be sheer folly for erroneous or fraudulent information to be tabled with a government agency. We have to rely on that.

When I say the system works, I know of no alternative, sir. I know of no other way to generate this kind of information.

[Translation]

Mr. Landry (Lotbinière): I think we have to get back to that question, because the topic is very controversial. The committee received a letter from the Council of Canadians indicating that information was erroneous. You have the letter, Mr. Chairman. We have to ensure that there is a follow up. New witnesses will have to appear.

Mr. Chairman, you know that we are on the verge of adjourning for the Summer recess, but people's health is more important than holidays. It is also important that we create a safe environment for the consumer.

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Consequently, we must get to the bottom of the issue. The Bloc Québécois has new witnesses it can call to appear. Among these are some physicians whose names I am not going to mention here, but they do want to appear before the committee.

Thus, Mr. Chairman, I am asking you to call those witnesses to appear next week, or the week after that, or in July. I don't care if I don't take holidays in July. The public's health comes first.

[English]

The Chairman: Thank you, Mr. Landry. We will be looking at that later today or tomorrow at our steering committee meeting.

Mr. Vanclief: Dr. Gunner, I just wonder if you could help me again with a couple of things.

In schedule F of the food and drug regulations, somatotropin, as has been discussed earlier, is listed. My understanding is that ``recombinant'' means the same thing in my layman's terms as ``synthetic'', or developed in a different way. Who made the decision that recombinant somatotropin is the same as somatotropin?

Dr. Gunner: I would turn that around, Mr. Vanclief. It's our interpretation that somatotropin, as listed in schedule F, part I, is general enough to cover rbST.

Mr. Vanclief: So then all of the other products listed in schedule F have fairly general interpretations for what each one of those might mean as well?

Dr. Gunner: You'd have to take a specific case-by-case examination, because they're different entities.

Mr. Vanclief: I'm just asking questions because these questions are out there.

If it's assumed that recombinant somatotropin is the same as somatotropin, then why are we doing any of what we're doing? We accept somatotropin.

Dr. Gunner: Because each product requires a notice of compliance and a drug identification number on its own.

May I clarify, sir? The term, as it appears in schedule F, part I, is considered to be generic and general enough to cover rbST as a class, but each product would require its own notice of compliance and drug identification number. That's the advice we've been given.

Mr. Vanclief: Thank you.

To clarify something else, I believe you stated earlier that sale of rbST in Canada is illegal.

Dr. Gunner: That is correct.

Mr. Vanclief: And importation for sale of rbST in Canada is illegal.

Dr. Gunner: Except for certain specific exemptions. Would you like me to deal with those?

Mr. Vanclief: Yes.

Dr. Gunner: You can't import bST for sale unless you are a practitioner - that means a veterinarian - a manufacturer, a wholesale druggist, a registered pharmacist or a visitor from another country. You cannot import it because it's listed under schedule F, part I, as I've explained.

The Chairman: A visitor from another country can bring it in?

Dr. Gunner: The regulation I'm referring to pertains to drugs generally. The visitor from another country was added as a humanitarian situation.

If you're a visitor, say, from Africa, and there's a certain disease condition there for which they have specific drugs permitted in that country but not in Canada, the visitor may then bring in that drug if it's for his own use. I'm talking about a general regulation dealing with drugs, and Mr. Vanclief is asking how bST fits into this scheme. The visitor is...for humanitarian reasons, for his own therapy.

Mr. Vanclief: I believe you also said the use of rbST in Canada is not illegal, and if that is the case, I have two questions. Is there any way that rbST can be legally used in Canada today, and can a private producer bring rbST into Canada today and use it in his own herd?

.1035

Dr. Gunner: No, unless he's a practitioner... those exemptions that I indicated. The Food and Drugs Act and regulations deal with sale, not with use, so the sale, whether it's a sale for money or it's being given away, is prohibited under the Food and Drugs Act and regulations. But in terms of bringing it in for his own use, it's only if that person meets the criteria I indicated of either being a veterinarian, practitioner, and so on.

Mr. Vanclief: So if a veterinarian owns a herd of dairy cows, the veterinarian can bring rbST into Canada today and use it in his dairy herd legally.

Dr. Gunner: That is according to the present regulations.

The Chairman: But can he use it on someone else's cows. Can he use it on Mr. Easter's cows?

Dr. Gunner: No, because -

Mr. Vanclief: I just want to make that clear. If a veterinarian is a dairy producer, owns dairy cows or part of a dairy cow, therefore being an owner of a dairy cow, that veterinarian can bring in rbST and use it on his cow, or cows.

Dr. Gunner: Under existing regulations, that is the case.

Mr. Reed: Dr. Gunner, you obviously search out information from a number of areas when you're going through this approval process. You talked about the international literature and so on. Just as a matter of interest, what happens if you get a report where there are two clashing results?

Dr. Gunner: It happens in many instances that there are different interpretations of test results, depending on what approaches have been applied to those results. If we're talking about methodologies for safety evaluation involving complex issues and toxicology and other disciplines, there often is a difference of opinion and a difference in interpretation of results. It's a question of reaching a consensus on what applies in the particular circumstance. It's not unusual that scientists will have differing views and interpretations.

Mr. Easter: I'm still concerned about what information is available, what is not, and what regulations apply to the release or the non-release of that information. Maybe the only way to bring it to a head, Mr. Chairman, is to move a motion.

I would move that the committee request from Health Canada the specific areas of investigation relative to the examination of rbST for use in Canada.

The Chairman: Mr. Easter, I just happen to have something in my own mind as to how we might do this under the Standing Orders: pursuant to section 108(1) of the Standing Orders, section 4 of the Parliament of Canada Act, and section 18 of the Constitution Act, 1867, the committee orders the production before it of a complete list of human and animal health concerns that Health Canada has been or will be considering as part of the review of rbST, and that the said documents be delivered within seven days of the date of this rder. Would that fit in with your thinking?

Mr. Easter: I hate to admit that your resolution's better, Mr. Chairman, but I'd accept it and move it.

The Chairman: Is there a seconder?

Mr. Steckle: Yes, Mr. Chairman.

[Translation]

Mr. Daviault: I fully support the motion. I also think that we should come back to get to the bottom of this matter. I think certain allegations were made by the Council of Canadians about statements made by the task force mandated by the Minister. Some witnesses, also, have not been heard. We still have some work to do, aside from examining the list of concerns that Health Canada has been or will be considering.

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I remember that in December 1994, on the Fifth Estate, we heard Dr. Brennan make controversial statements, to say the least, about somatotropine and the two million dollars in bribes offerred by Monsanto. That is the term that was used. I think we are dealing with quite a broad topic here, one which necessitates further sittings by this committee, either now or in the Fall.

[English]

The Chairman: Mr. Daviault, you're a representative on the steering committee this afternoon. We'll be able to talk about that.

Motion agreed to

The Chairman: I just want to read something else into the record to Dr. Gunner. It's an article on the powers of parliamentary committees. Just let me quote from here:

Are there any other questioners on this issue?

Dr. Gunner, I want to take this opportunity of thanking you for coming forward today to the committee. It was very useful in terms of trying to get a good understanding of where Health Canada is coming from on this issue. There is more information that this committee requires, and hopefully we will be able to clear that up in the near future.

This meeting is adjourned to the call of the chair.

;