STANDING COMMITTEE ON HEALTH

COMITÉ PERMANENT DE LA SANTÉ

EVIDENCE

[Recorded by Electronic Apparatus]

Tuesday, April 3, 2001

• 1109

[English]

The Chair (Ms. Bonnie Brown (Oakville, Lib.)): I'd like to call this meeting to order.

We have a series of guests who have information for us. I should also alert my colleagues on the committee to the fact that we have a couple of other items of business at the end of the meeting. One is a budget for this committee, which should be taken to the liaison committee today if we want to equip ourselves with some funds to do some things. And the second is a question about the timing of Thursday's meeting. I will get into this at the end of the meeting.

As for now, we are continuing with our examination of the relation of certain donor exclusion policies to the safety of the Canadian blood supply. And I'm going to use the chair's prerogative to change the order a little bit, because we have one witness who is listed near the end of the meeting who can only speak to us now because he has to get back to the university. So I'm going to begin with Dr. Bill Cameron, who is a professor of medicine and a specialist in infectious diseases and HIV, for his comments.

• 1110

Dr. Cameron.

[Translation]

Mr. Réal Ménard (Hochelaga—Maisonneuve, BQ): Would it be possible to have the documents before beginning, a list of witnesses for example?

[English]

The Chair: Which document?

[Translation]

Mr. Réal Ménard: I am talking about all of the documents we are supposed to have, such as the list and the briefs. Last time, we were given them at the end. If we had them at the beginning, that would help us to understand better.

[English]

The Chair: He'll find it for you.

Thank you for your patience. Now we'll hear from Dr. Bill Cameron.

Dr. Bill Cameron (Professor of Medicine, Specialist in Infectious Diseases and HIV, University of Ottawa): Thank you, Madam.

I was asked on short notice, and I'm happy for your consideration to let me go first. I was asked to speak to this question: Is the policy of blanket exclusion of gay men and many others from voluntary blood donors rational based on the best evidence for protection of patients medically treated with blood products?

In the past 15 years of my clinical practice, I have seen half a generation of hemophiliacs die from infectious complications of their medical care. Had the exclusionary policies of blood donation in place today been in place 20 years ago, this might not have happened in Canada in such a tragic manner. The policies of today are a hard response to hard lessons of past experience and knowledge gained about infections transmissible by blood transfusion. Experience is the best teacher, but the tuition is an exorbitant fee.

Is the response of today greater than need be, and is the response effective in any manner? The objective of screening of would-be donors from blood donation based on epidemiologic or demographic “risk groups” is to protect our blood supply as best we can rather than rely on confession of individual risks about sex, which is a private thing for many of us. Even elicited with any degree of respect and confidentiality, the unnecessary exclusion of similarly confessed risk groups is used. This may not be efficient, but it may exclude more potential donors at unknown or otherwise unstated real risk, who would otherwise be included, if it can be done with the good will of, and respect for, those who happen to reside in any such defined risk group.

In Ottawa, like in so many other North American cities today, this year there is a resurgence of sexually transmitted syphilis in local outbreaks and continued increase in new HIV infections in gay men and in other people. To rely on laboratory screening of infectious diseases that are known to be transfusable is to limit us to the technical limits of such a laboratory test and the logistical limits of applying those tests.

It will also limit us to the exclusion of known infections. Less than 5%, perhaps, of viral infections of humans are known by the best guess of those who are expert in the field.

Human diseases, even old and common ones, are turning up to be infectious in their real causes. How are they transmitted? How many are transfusable? We don't know.

Canada has a recent history of a small epidemic of Creutzfeldt-Jacob disease due to injection of human growth hormone to children with a cruel disease, pituitary dwarfism. I was excluded from blood donation this year, after a long history of regular blood donation that I wanted to continue, after a year away on sabbatical in England. My exclusion was done with great sensitivity and respect and with fair privacy, too. I belong to one of those risk groups of persons who have lived in the United Kingdom or in France.

• 1115

The issue is mad cow disease and the human infection that's now appearing in Europe. Never mind that I did not eat the beef there, as best I can recall, and no, never mind that it was in the year 2000, after the mad cows were gone from the food, at least we're told so. Rather than depend on my recall or my confession, the whole group is excluded. Never mind that we don't know that the human equivalent of mad cow disease is or is not transfusable. It might be. Once burnt, twice shy; and I'm out of the donor pool.

The policy of blanket exclusion of risk groups by confession, regardless of individual factors which may or may not be present, is far less than perfect. But it may help in keeping our blood supply safe from infection, both known and unknown, which may occur more frequently in some groups than in others. The problem is how to use probabilistic determinants with sensitivity and respect but also effectively.

This may be more just to those who are to be transfused or treated with blood products than respectful of the altruism of our potential donors. The question is now, in my opinion, how to continue this policy best with the greatest respect for our donors, but also to be most effective.

How not to do this has been demonstrated in an unnamed Mideast country, where donated blood from people of a perceived, visible risk group was quietly discarded from the blood supply in that country. When this became known, the offence taken was politically and socially harmful and quite offensive to the goodwill of many altruistic donors. This is how not to do this.

The issue, in my opinion, is how to use probabilistic determinants of risk of known infectious diseases and infectious diseases that are not yet known, or for which we do not yet have tests, which may apply to some groups more than to other groups, as best we can.

The Chair: We could have a quick round of questions with Dr. Cameron before he leaves.

Mr. Merrifield, I will ask you to keep it short because he doesn't have much time, and we have to save time for all our other witnesses, too.

Mr. Rob Merrifield (Yellowhead, CA): I am going to keep it very short. I think it was a very good presentation. I think it was very direct, and I don't have any questions. I'd just like to thank you for coming.

The Chair: Good. Mr. Ménard.

[Translation]

Mr. Réal Ménard: Mr. Cameron, the committee is looking into whether or not the criteria for exclusion in place since 1977 for men who have sex with men are discriminatory. Do you believe that such exclusion is still justified giving the new technology available? We will discuss the PCR test technology later. Do you believe that the more sophisticated technologies for detection allow us to review these criteria?

[English]

Dr. Bill Cameron: Thank you.

It's not my decision to keep this system, and I recognize many deficiencies in this system. The question is how to do this best.

You would put great reliance on a technology to detect one condition, HIV. Will this test identify other sorts of HIV that do exist in other countries today and that will appear in the future? The answer to that is no. There are strains of this virus, and there are related viruses that may be sexually transmissible, that are not captured reliably or with the same reliability in our tests. You would also perhaps appraise the logistical limitations of screening, with 100% reliability, a huge and continuous supply of donated blood.

I would say we need to apply both things to maximally protect those who are to receive blood donation. And there may be a cost to this in being discriminatory to some people who are willing, out of goodwill and the same altruism, to identify themselves as belonging to a risk group. We need both of these things in order to maximally protect our blood supply.

• 1120

The Chair: Mr. Dromisky.

Mr. Stan Dromisky (Thunder Bay—Atikokan, Lib.): I guess we're talking about HIV, Madame Chairperson, and I'm just wondering what process and what kind of tests are given to determine if there's any other possible condition in the blood that is being donated that can be transmitted to the recipient. Is there any other test that you people do to determine if the blood is contaminated with something that could affect the health of the recipient?

Dr. Bill Cameron: Unfortunately, there are more infectious diseases than there are diagnostic tests.

Mr. Stan Dromisky: And what does your clinic or your... Just exactly how far do you go in testing it, then?

Dr. Bill Cameron: Well, testing—

Mr. Stan Dromisky: Do you just go by this form that's been given to us regarding the sexual behaviour of an individual?

Dr. Bill Cameron: If we're talking about the process of donating blood and then screening the blood supply, first a person like myself is asked a sheet of questions about many personal things and many things that I would be happy to confess to—travel, for instance.

After that, a person may or may not be asked to continue and donate blood. The blood is then taken to a laboratory, and a battery of tests is applied to it. We have three sorts of tests now that can be applied to identify HIV infection. We test for syphilis. We test for other infectious diseases including the hepatitis C virus. But I guarantee you that there are other sexually transmissible viral infections that may not be excluded by testing for want of tests. And this blanket exclusion policy is really a response to things that we do not know rather than to things that we do know.

It's based on past experience when, for want of knowledge, we did not do something, like exclusion from donor pools, that would have been a good thing to do in the past.

Mr. Stan Dromisky: All right. I'll just follow through with that latter statement. For the things that you do know, and conditions that you're aware of, are we in a position where we're not doing the proper tests—and let's assume we do have tests—simply because we don't have the resources or the equipment or the personnel?

The Chair: Excuse me, Mr. Dromisky. Dr. Cameron is not attached to the Canadian Blood Services, so everything to do with their system should be asked to the witnesses from that body.

Mr. Stan Dromisky: Okay.

The Chair: Dr. Cameron is—

Dr. Bill Cameron: I'll be happy to respond, regardless.

I think that for those things we do know, we have applied every possible test—in fact, probably more than is justified—in the same manner that we exclude from donor pools more potential donors than is justified. It's not efficient. It's designed to be maximally safe.

So for those things that we do know, I think that we have responded doubly to the issue based on deficiencies of the past.

The Chair: Thank you. I would ask the other questioners if their questions might be better directed to some of the other witnesses they see on the list.

Madame Sgro was next.

Ms. Judy Sgro (York West, Lib.): Very quickly, because there are a lot of people we want to hear from... Dr. Cameron, I hear that you would not support changes to the current system of screening that we have in Canada?

Dr. Bill Cameron: I think there's a need for continuous changes based on the evolution of new knowledge, but I think the concept of blanket exclusion of epidemiologic risk groups is a good and necessary policy.

Ms. Judy Sgro: Okay.

The Chair: Mr. Owen.

Mr. Stephen Owen (Vancouver Quadra, Lib.): Thank you, Dr. Cameron.

I understand that the fastest-growing incidence of HIV and AIDS infection in the United States is poor black women of childbearing age. I suspect, and there is some evidence to support, that a similar incidence is occurring among poor native women in Canada. This suggests that the current phenomenon of the infection in North America is mimicking the heterosexual pandemic in Africa, with some very similar characteristics around power over one's own body, poverty, and exposure to other diseases.

• 1125

So from the point of view of epidemiology and risk, we were addressing the question of over-exclusion. But is there a risk of under-exclusion? If you were designing such a checklist in Kampala, would you have additional categories of exclusion? If so, might it also be reasonable to include those on a Canadian list?

Dr. Bill Cameron: From the point of view of maximizing safety of our blood supply, yes. There are many risk groups for known infectious diseases that could be excluded on a basis of probability.

I think that question would come down to an actuarial exercise in risk calculation. Perhaps it would be conducted by an epidemiologist who would know, for instance, the prevalence of an infectious disease in an identifiable demographic or epidemiologic group of people. That calculation of risk could then be applied to determine whether an exclusion policy would be effective or not.

The question in my mind is not whether it would be efficient—that is, how many donors would be unnecessarily excluded. What's of paramount importance is people's right to receive blood that is safe. We do that to the best of our ability. For that reason I would say yes, many risk groups could be treated in that manner—with due process, of course.

I don't see the issue as discrimination against one group or another. But it should be calculated, it should be done in a manner that's most effective, not most efficient. For instance, we could make a list of demographically or geographically identifiable groups, and apply policies that would also be sensitive—that would respect the dignity and altruism of people who come forward to donate blood.

Mr. Stephen Owen: Risk management can be looked at as an exercise in measuring two things. One is the likelihood of an adverse occurrence, and the other is the consequences of such an occurrence. If I could try to sum up your evidence, I think you're saying that the consequence of an occurrence in this situation is so grave that notwithstanding the low likelihood, extraordinary measures need to be taken.

Dr. Bill Cameron: I don't see these as extraordinary measures, but I'd agree with your summary. I would point to our experience with transmission of Creutzfeldt-Jakob disease to children with pituitary dwarfism, and with transmission of hepatitis C and HIV to many people, to illustrate very concretely the gravity of this issue. Safety comes first.

The Chair: Dr. Cameron, thank you.

We'll now move on to panel one. We'll begin with Dr. Donald Sutherland.

Dr. Donald Sutherland (Director, Bureau of HIV/AIDS, STD & TB, Centre for Infectious Disease Prevention and Control, Department of Health): Thank you, Madam Chair, members of the committee.

At Health Canada, it is my responsibility to try to track epidemics of HIV and other diseases in Canada, and to report any evidence that helps this committee to consider the issue. Today I intend to draw your attention to three papers we've produced recently that consider the incidence of HIV. I've limited this primarily to discussing HIV.

One of the critical issues here is the window period—that is, the period between the time of infection with HIV and the time when it's detectable through the current laboratory testing methodologies. Therefore, one piece of the evidence you need is the number of new infections occurring each year.

• 1130

In the national HIV prevalence and incidence estimates for 1999, there was no evidence of a decline in overall incidence. The prevalence of HIV in Canada rose from 40,000 to 50,000 during the period from 1996 to 1999, the last year for which we have reliable estimates. In that time, there was a rise in the different risk categories we describe.

I would like to point out the difference between prevalence and incidence. Prevalence is the number of people living with HIV in any year, and incidence is the number of new HIV infections occurring. The number of new infections overall in Canada stayed at about 4,200 in those two years. However, the distribution has changed.

The number of new infections estimated in injection drug users went from 1,970, which was about 50% of the epidemic in 1996, down to 1,430.

In the category of infections in men who have sex with men, estimates went from 1,240 up to 1,610. This shows an increase in incidence among such men in Canada, as you heard from Dr. Cameron.

If one looks back from the current time to the early part of the epidemic, the left-hand side of the graph shows the proportion of the epidemic attributable to injection drug use, and in the middle the proportion attributable to men having sex with men.

In terms of HIV testing for Canadians, 15,000 current HIV infections may not be diagnosed. We have called this the hidden epidemic. While it's true that many of the persons at risk have come forward and been tested for HIV, we estimate that 15,000 people who are positive have not yet been tested. Therefore they're perhaps ignorant of their condition, and they're obviously not availing themselves of care or counselling.

So a proportion of the epidemic is hidden, and it's very similar to the hidden proportion in the U.S., or the U.K., or other countries whose epidemic is at a similar stage.

Last November we produced a document indicating a rise in HIV infections among men who have sex with men.

The Chair: Could you give us the exact title of the document you're referring to?

Dr. Donald Sutherland: There are three of them, all called HIV/AIDS Epi-Updates. The first one I spoke to is “National HIV Prevalence and Incidence Estimates”. The second is “HIV Testing Among Canadians”. And the one I'm referring to now is “Recent Data on HIV Infections Arising in Canada Among Men Who Have Sex with Men”.

The Chair: Thank you. Go ahead, Dr. Sutherland.

Dr. Donald Sutherland: Thank you.

This document tries to put forward the data we had available at the end of last year, indicating that the epidemic was again changing character in Canada: it was rising in the population of men who have sex with men, and that population had previously had a decline in HIV infections. So it was of considerable concern that it seemed to be reappearing among men who have sex with men.

• 1135

It's been important, first of all, to understand why that might be occurring, confirm that it is occurring, and then obviously move on to programs that would intervene. So here is a series of information about the numbers of new infections.

In the studies in Ontario in particular, which made some estimates from the period 1996 to 1999, the number of new infection rates in that study went from 0.87 infections per 100 person-years up to 2.07. There were a couple of rates quoted from cities like Toronto and Ottawa at about 2.5.

There were other studies that are outlined here, but they all tell a somewhat similar story, although in Montreal the cohort study there showed a stable rate of infection.

On the bottom of page 2 under “Risk Behaviour Data” there was some self-report data from the Montreal cohort study. And as you remember, this study showed no increase in the number of HIV infections, but it did show an increasing trend of unprotected anal intercourse with a casual partner between the last two years that were in the study, 1998-99. We tried to track not only the occurrence of HIV, but those markers that would indicate the risk may be rising. There have been some other reports on rectal gonorrhea and some syphilis outbreaks in Canada that have also raised the alarm.

It's not just in Canada. On page 3, at the bottom, there are some data and some references to research in San Francisco, Amsterdam, Australia, and other cities in the U.S. with respect to increasing risk for men who have sex with men.

The only other point I'd like to make for the committee's consideration is that with respect to the window period—that is, the period between infection and detection by testing—there has been some recent evidence published to show that those persons who are co-infected with hepatitis C when they get their HIV may not show a normal pattern of antibody development. Some of those, and in particular one health care worker who got infected with hepatitis C and HIV at the same time, did not sero-convert, did not become test-positive for HIV, until after six months after the exposure.

So while the vast majority of persons exposed to HIV will get their blood tests to go positive within weeks of that exposure, there are a few people whose antibody test will not convert during the period in which they may be infectious. So there is some new evidence about the window period where we're not as confident as we once were that the window period was very short, and it's because the person doesn't create the antibodies during that period of time.

Thank you.

The Chair: Thank you, Dr. Sutherland.

Dr. Hindieh.

Dr. Farid G. Hindieh (Acting Head, Blood Components Section, Blood and Tissues Division, Department of Health): Thank you, Madam.

Some of my introductory notes and comments are going to repeat what Dr. Cameron presented, and I'll add a few other comments.

I am part of the blood and tissues division of the Bureau of Biologics and Radiopharmaceuticals, and we are the division that deals on a day-to-day basis with the regulation of the blood system in Canada.

In the Canadian blood system, Canada obviously has a regulatory role and our primary mandate is to assure and maintain the safety of the system. The safety of a modern blood system, as we see it, relies on two pillars: one is the donor history screening to elicit potential factors that may present a risk for the donor or future recipients of the blood products, and also specific testing to determine immunological characteristics of the blood and detect the presence of a number of viruses that can be transmitted through blood. As Dr. Cameron pointed out, we test for a number that are known, but we cannot test for everything.

• 1140

Transmissible disease marker testing has evolved and improved since it was first introduced in the early 1980s. However, testing still has its shortcomings and imperfections despite the improvements.

Aside from the potential for error, which is always possible, however minimal under controlled conditions, even the most modern tests, such as nucleic acid amplification tests, which you are going to hear about later, are unable to detect all infected individuals. I mean all infected individuals. Of course it does detect the majority, particularly during the early phase of these infections, which we call the window period.

The introduction of the combination of complementary donor screening through questionnaires and the testing steps since the early 1980s has also resulted in the dramatically improved safety of the blood system in all industrialized countries. Currently our Canadian blood supply is considered very safe, with only a minimal residual risk remaining.

Although it is recognized that a no-risk transfusion is not achievable, the Canadian public and the regulator continue their demand to introduce new steps or tests that have the potential to add very small increments to the safety and sometimes, or often, at a very high cost.

Following the unfortunate tragedies of the 1980s the public has, on the other hand, zero tolerance for any intervention that may potentially reduce the high level of safety we have achieved.

The initial screening of donors through a very long and detailed list of medical and personal history questions strengthens and complements the imperfect testing. It must be remembered that the purpose of the questions is twofold: to protect the donor and the potential recipients. The thrust of the questions aimed at identifying individuals who belong to high-risk groups is to attempt to minimize the possibility of collecting blood from an infected individual, taking into consideration the imperfection of our present testing methods.

The groups we're talking about include drug users, hemophiliacs, recipients of blood products, persons receiving money or drugs for sex, natives or residents of some African countries, as well as males who had sex with another male. Donors considered at risk of carrying and transmitting infectious agents can be deferred from donation, based on their response to the questions.

The deferral of donors who belong to these groups is based on available and current epidemiological data that Dr. Sutherland just presented to you, and the knowledge of the higher prevalence of well known and less well known, as Dr. Cameron pointed out, transmissible infections in these groups.

It is well recognized and acknowledged that this approach will, unfortunately, eliminate individuals who are healthy and unaffected by the disease. However, the seriousness and potentially devastating effects of these diseases have forced the operators and regulators of the system to choose the precautionary approach.

Canada is not alone in adopting this approach and deferring donors considered to belong to high-risk groups. Based on similar epidemiological data, the same policies are currently followed by all industrialized countries, namely in Europe and North America.

• 1145

In addition to the fundamental safety reasons, the issue of harmonization with the U.S. FDA regulations is of particular importance for Canadian blood products because the plasma collected in Canada is sent to the U.S.A. for further manufacturing into final products.

Health Canada, through its public health component, as you heard from Dr. Sutherland, is constantly monitoring the incidence and prevalence of important relevant infectious agents in Canada and worldwide. It is following diligently the progress of all applicable new technologies in order to update our regulatory requirements and enhance the safety of our blood supply.

Health Canada strives under all circumstances to make the best possible decisions based on firm scientific evidence. We are aware of the deficiencies of the questionnaires currently used by CBS and Héma-Québec and also outside Canada. The formulation and effectiveness of existing questions have been repeatedly criticized by different groups. We recognize that ideally each question should be validated for its clarity, unambiguity, and effectiveness in achieving the intended result.

Unfortunately, practical difficulties, concerns regarding the use of experimental tools in a live blood supply environment, and the urgency sometimes of introducing new safety criteria are often impediments that work against achieving this goal. These concerns are shared globally with other regulatory agencies facing the same difficulties. We have participated in a number of international workshops to attempt to find the most suitable way of going around it.

Anyway, the bottom line is we must recognize that right now we have a very safe system. If we're going to change anything in the system, we are certainly going to require that sufficient scientific evidence is presented in order to reassure us that no negative impact will occur.

The Chair: Thank you, Dr. Hindieh. We've had two speakers from Health Canada.

I'd like to move to Canadian Blood Services, Dr. Graham Sher.

Dr. Graham Sher (Vice-President, Medical, Scientific and Clinical Management, Canadian Blood Services): Madam Chair, our CEO, Lynda Cranston, will speak, if it's okay.

The Chair: Lynda.

Ms. Lynda Cranston (Chief Executive Officer, Canadian Blood Services): Thanks very much, Madam Chair.

Members of the committee, I want to thank you for giving Canadian Blood Services the opportunity to appear today. Dr. Sher, who is CBS's vice-president of medicine, is also with me.

As you may be aware, Canadian Blood Services was created in 1998 as a result of the Krever inquiry. We have responsibility for the blood system in all provinces and territories except Quebec. We operate at arm's-length from government and with strong authority in order to prevent events such as those that have occurred in the past. The provincial and territorial ministers of health have charged CBS with responsibility for ensuring a safe, secure, cost-effective, and affordable supply of blood, blood products, and their alternatives and with responsibility for supporting the appropriate use of such products. As you also are aware, CBS is regulated by Health Canada through the Bureau of Biologics and Radiopharmaceuticals.

From the beginning we have worked with the mantra that safety is paramount. For this reason donors are asked to go through an extensive and, it must be said, intrusive screening process before they can donate. We ask very personal questions, and we ask these questions every time a donor comes in, whether he or she has donated once or a hundred times. Once a unit is collected, it is subjected to a barrage of tests, tests for HIV, Hepatitis B and C, HTLV I and II, and syphilis. All of this is done to reduce the risk of disease transmission as much as humanly possible.

Since assuming responsibility for the system, we have introduced nucleic acid testing for Hepatitis C, a test that is thought to catch the virus earlier than our current test, and we are preparing to introduce similar testing for HIV this spring. We've also introduced universal pre-storage leuko-reduction, a process that filters out the white cells and thereby reduces the incidence and severity of side effects, such as chills and fever, in the recipients of blood products.

• 1150

Of all these safety procedures, the donor screening questionnaire has come under the most scrutiny. Our board of directors has received representations from the Canadian Federation of Students and the Carleton University Gay, Lesbian, Bisexual and Transgender Centre challenging the validity of the questionnaire and its content, purpose, utility, perceived biases, and perceived discrimination. We have also received letters and e-mails with similar questions from people across the country.

As a result of such comments, we are planning a consensus conference to address the issue of our donor deferral criteria. Its format and structure are based on a model created by the National Institutes of Health in the United States. The steering committee for this conference includes representatives from Canadian Blood Services, the Canadian Federation of Students, the Canadian AIDS Society, the Thalassemia Foundation of Canada, and Héma-Québec and blood donors.

The conference will address issues of donor eligibility as they relate to the risk of transmission of HIV and Hepatitis B and C. It will be used to define standards for defining donor eligibility criteria. It will also be used to determine the fairness of deferring donors based on risk factors, risk behaviours, and risk groups. Finally, it will be used to determine how the screening process can and should balance the rights, needs, and privileges of donors and recipients.

Specifically, the conference will address the following questions: is the current donor selection process effective in minimizing risk to recipients? What evidence is there that the process we currently use to select donors keeps healthy donors in and excludes donors who might pose a risk? What principles should guide donor selection in Canada? Finally, what are the highest priorities for research to ensure the safety of the blood system in Canada?

Members of the standing committee are very welcome to attend this conference, which we are planning for November 7 to 9 in Ottawa.

The conference is meant to help us explore equally effective ways of screening donors. The goal is to maintain or improve the safety of the blood supply with a questionnaire that is perhaps more specific in the sorts of questions that are asked or risk behaviours that are identified.

Any change to the donor screening criteria is a time-consuming process. We must gather a great deal of scientific and medical evidence to indicate that the change would not pose an additional risk to the donor or the recipient and prepare a submission to Health Canada. It is our responsibility as operators of the system to make the case for change, and it is Health Canada's responsibility to approve or disapprove of that change. This consensus conference will help us toward the goal of gathering evidence. This is a lengthy process but one that CBS is committed to, because we take comments regarding the donor screening process closely to heart.

Dr. Sher and I would be pleased to answer any of your questions. Thank you again for the invitation to join you.

The Chair: Thank you, Ms. Cranston.

Next is Mr. Germain from Héma-Québec.

[Translation]

Dr. Marc Germain (Héma-Québec): Thank you, Madam Chair.

I was given very short notice for my testimony before this committee. I would therefore ask that you please excuse the somewhat improvised nature of my speech. I would be happy to answer your questions in English.

I will quickly remind you that Héma-Québec is responsible for the blood supply in the territory of Quebec, like the CBS for the rest of Canada. Héma-Québec is subject to the same blood safety regulations as the CBS.

At the outset, I would like to specify that it is Héma- Québec's position that, in the past at least, the current criteria excluding men who have sex with men were completely justified for the reasons detailed by Dr. Cameron. However, Héma-Québec also recognizes that the current situation justifies a reassessment of this policy in order to determine if it is still appropriate. To this end, Héma-Québec is quite happy to be able to participate in the consensus conference which will take place in November and which will assess, not only the specific question of excluding gay men, but also the entire blood donor selection process, and specifically the questionnaire that is administered each time a donor gives blood.

• 1155

I think that reassessing the situation is justified for a number of reasons, including the constantly changing nature of the epidemiology of HIV infection, of which Dr. Sutherland spoke, and also the very recent introduction of new diagnostic tests which blood banks use to test donors, specifically the introduction of nucleic acid testing. The nucleic acid test for the aids virus was introduced by Héma-Québec about two months ago. These new facts require us to reassess the issue of donor screening by way of a questionnaire.

Any review or change considered by transfusion organizations when it comes to testing blood donors must nonetheless take into consideration the fact that we are currently at the limit of maximum security when it comes to blood transfusions. Dr. Hindieh commented on the fact that any new measures added to improve the safety of transfusions have a very minimal marginal benefit, but one that is very desirable and welcomed by recipients, so any changes in our current policy must demonstrate quite clearly that it will not threaten in any way the safety of blood products.

Without going into detail, I would like to share with you the efforts that Héma-Québec is currently undertaking to assess this situation. A few months ago, we undertook an assessment of both the risks and the benefits resulting from any change in the current exclusion criteria regarding men who have sex with men. This assessment is based on mathematical modelling. The assessment is being done in co-operation with experts in the field, including Dr. Robert Remis who is here today and who will be testifying later on. This assessment aims to determine, on the one hand, new risks if the current criteria were modified and, on the other hand, to assess the benefits of any such change, specifically the inclusion of new blood donors that would be added to the pool of donors.

Without going into the technical details, I would nonetheless like to add that this is a very complex issue which has already been discussed on a number of occasions by committees of international experts, and as recently as the fall of 2000, by the American Food and Drug Administration. At that time, the American experts decided that they were not able, based on the data available at that time, to advise whether or not it was appropriate to modify the selection criteria for homosexual men. In view of the lack of data, they invited the scientific community to further explore the details of the current situation.

The study currently underway, which we hope to disseminate to the scientific community in the near future, seeks to further the scientific discussion and attempts to quantify, as much as it is possible, what the impacts of such a change would be, both positive and negative. It is a very complex issue. For now, we are simply discussing the issue of HIV infection, but as you have heard today from other experts, there are other factors to consider, specifically other known infections and infections which are not yet known. This is a debate that will likely be quite complex, but one that both Héma-Québec and the Canadian Blood Services wish to explore. We hope we will be able to come to a satisfactory conclusion.

Thank you.

[English]

The Chair: Thank you, Mr. Germain.

We'll have a round of questions. I want to remind my colleagues that we have another panel, which has yet to present, so please don't dream up questions. If there's something you really need to know from these people, put your name forward.

Mr. Merrifield.

Mr. Rob Merrifield: You suggest I dream up questions?

The Chair: No.

Mr. Rob Merrifield: Actually, I found the panel very interesting.

• 1200

With regard to the questionnaire, are the answers voluntary, and is it a criminal document? I don't know if that's a fair question for any members of the panel.

Dr. Farid Hindieh: My colleagues here could certainly answer in terms of the legal liabilities, because they're much more directly involved, but I would mention that at the bottom of the questionnaire, after all the questions have been filled out, the donor signs his or her name to say that all the answers are truthful and they understand the consequences of not providing truthful answers.

Mr. Rob Merrifield: Is it a criminal act to...

Dr. Graham Sher: Perhaps I can expand on that.

There is in fact legal precedence in this country for donors who knowingly lie or pose a risk to the system and attempt to donate. Successful charges have been laid against donors in the past.

One other point I might add for the committee's information is that in addition to the screening questionnaire and the screening test, there is another process built into the overall safety net of eliminating donors at risk, a process known as the confidential unit exclusion. This is a process whereby donors may willingly or knowingly answer incorrectly on the screening questionnaire or the record of donation, and at the end of that, if they feel they have not had the privacy or confidentiality to answer truthfully, they are left in a room on their own, essentially like a voting booth, and given the opportunity to check off “Do not use my blood for transfusion”. Once that blood unit that has been donated gets to the laboratory, it is then destroyed as a result of the donor indicating this.

You may ask why we would have that process in place. Let's say we go into a workplace to collect blood, and a group of individuals goes down at lunchtime to donate. If one individual has lifestyle or other risk factors they don't want colleagues to know about, they don't want to be seen to be deferring. They are thus given the opportunity to go through the questionnaire, knowingly not tell the truth, and then exclude their unit from transfusion purposes.

This was a system put in place in 1985 in New York and Toronto, essentially simultaneously, and it has achieved an additional element of safety above and beyond the screening questionnaire and the testing we do in the laboratory.

Mr. Rob Merrifield: Just one more, Madam Chair.

With regard to the questionnaire and the conference that's coming up, you're suggesting safety first, of course. If you're going to change the questionnaire, it sounds to me as though you would tighten up rather than relax any of the questions. Is that what you're suggesting?

Ms. Lynda Cranston: I think it could be a matter of either. It would depend on the discussions in the consensus conference. That's why we're using that kind of approach. We have to take into consideration not only how donors feel about the questionnaire but also how recipients would feel if questions were changed, and particularly how they then would perceive the safety issue around that unit of blood.

So the questionnaire might not necessarily change, but certainly we want to get into the room the people who have concerns about the questionnaire. Some believe we do discriminate because of the kinds of questions we ask. On the other hand, we also want to listen to what recipients have to say. When we have to get a unit of blood, we also must take into consideration the concern around the recipients, the consumers, and not just the donors.

I guess we're trying to come to some kind of consensus around the issue. We must take medical and scientific evidence, and then, whatever our position comes out to be, prepare for Health Canada to assess whether or not the questionnaire should change.

Mr. Rob Merrifield: One more?

The Chair: Okay, Mr. Merrifield.

Mr. Rob Merrifield: Dr. Sutherland, with regard to your graphs, you've projected to 1999. You must have some projections or suggestions as to where the infection could be going from here.

Dr. Donald Sutherland: It's difficult enough to come up with figures that are relatively current in terms of the number of new infections. We've started to use other indicators—for instance, the occurrence of other sexually transmitted diseases or even other blood-borne transmissions like hepatitis C—as a way of predicting whether HIV is likely to follow. But it's like predicting human nature: it's difficult to know whether behaviours will change, and if harm reduction or safer sex messages will be successful.

• 1205

Our experience to date is that the epidemic is not declining as we had hoped it would, so we think it's very important to try to be doing studies in current time as best we can.

The Chair: Thank you, Mr. Merrifield.

Mr. Ménard.

[Translation]

Mr. Réal Ménard: First, before asking my questions, I would like to ask Health Canada if it is possible to table a document on what are the concrete conditions for the granting of a license, as well a document on the process which allows Héma-Québec and the Canadian Blood Services to obtain a license. I was expecting that that was what we were going to be talking about this morning and I did not find your presentation very useful with regard to our concerns.

I would also like to ask the Canadian Blood Services and Héma- Québec if they could provide a list of the tests that are done, what purpose they serve and what scientific information they provide. I ask this for information purposes only; these are not my questions.

First, for clarity's sake, are the nucleic acid test and PCR technology the same thing? I would like you to explain the differences and what we should know about that.

Second, is the PCR test now being used by blood banks, and could it, in any significant manner, reduce the opportunity period during which the organism produces antibodies that are not yet detectable?

As for you, Mr. Germain, you made what I thought was a very good presentation. I would like you to speak more about your modelling study. When do you think it will be available and will you share it with us?

Fourth, how do you respond to groups that say that the problem with the questionnaire is because of the fact that it excludes people based on a categorization, but not necessarily based on behaviour, and that it is based on behaviour that we should be excluding people instead of excluding only homosexuals as a collective group?

Those are my four questions and I hope, Madam Chair, that we will have the documents that I requested of Health Canada.

Dr. Farid Hindieh: First I will let Dr. Ganz answer the question on PCR technology and the nucleic test.

[English]

Dr. Peter Ganz (Manager, Blood and Tissues Division, Department of Health): Madame Chair, just in terms of Monsieur Ménard's question, and to provide some background on nucleic acid testing, the current tests for infectious diseases such as the HCV virus—hepatitis C virus—and HIV in blood donors don't detect very recent infections.

For HCV, for example, the period between infection and when you can detect—the so-called window period—is approximately 60 days. For HIV, it is approximately three weeks for most cases, using the current licensed tests.

Now, nucleic acid testing—and PCR would be, I guess, a synonym—is a new technology which can reduce the window period for HCV. You can actually reduce it by 50%.

[Translation]

Mr. Réal Ménard: Wait. PCR and NAT, are they the same thing?

[English]

Dr. Peter Ganz: Yes. Nucleic acid testing is a more generic term for detecting nucleic acids, be it RNA or DNA. PCR is a kind of nucleic acid test.

The tests that are now used for screening donors for HIV and HCV rely on the detection of antibodies which develop in response to infections with these viruses. The NAT testing relies on the detection of genetic material of these viruses, which precedes the development of antibodies to the viruses.

Nucleic acid technology detects HIV three to five days earlier in infection than the currently approved serological tests, or the ones that use antibody detection. This narrowing of the window period due to NAT testing for HIV is predicted to detect about one to two cases every two years in Canada based on a one-tenth U.S. prevalence. However, one cannot assume the same impact—

[Translation]

Mr. Réal Ménard: Wait. We need to understand what you are saying. We do not have the scientific background that you have.

Are you stating before this committee that the introduction of the PCR test allows us to reduce the latency period, thus, reduce the window of opportunity by three to five days? Is that what you are saying?

• 1210

[English]

Dr. Peter Ganz: Yes that's correct. It does not close—

[Translation]

Mr. Réal Ménard: Currently, it is three weeks. If there were a NAT test in all of the blood banks and in the tests currently authorized in Canada, we could definitely reduce this period by three to five days. Am I correct?

[English]

Dr. Peter Ganz: Exactly. Correct. As I mentioned, in the case of HIV, in addition to the NAT testing there is another test that is used. It's called the p24 antigen test, which detects the presence of HIV protein—the virus protein that may occur prior to the development of antibodies—but still not as early as the presence of the virus' genetic material.

NAT testing for HIV would provide minimal advantage for HIV screening—just that additional three to five days. It does not allow for you to detect HIV earlier.

[Translation]

Mr. Réal Ménard: But is the PCR currently obligatory, among the different organizations such as Héma-Québec and the Canadian Blood Services? Is the PCR systematically used in blood banks?

[English]

Dr. Peter Ganz: Yes, it is. As you heard from Canadian Blood Services, they are beginning to introduce HIV NAT testing in the spring. Héma-Québec has already started doing HIV NAT testing.

Now Health Canada has been very proactive in advocating the implementation of such testing by the operators. Although still under an investigational, introductory phase, the new technologies are being implemented by both operators. Now the NAT testing for hepatitis C offers, as I've indicated, the greatest possibility of detecting potentially infected units of blood because the window period is narrowed from 60 days to 30 days, whereas for HIV, the benefit is three to five additional days.

Now with HCV, the test for which was introduced in Canada over a year and a half ago, the prediction was that we would be able to interdict an additional three to five cases of HCV per year with the introduction of this technology over and above—

[Translation]

Mr. Réal Ménard: Pardon me, I do not want to take too much time, because I would like to hear from Mr. Germain and your colleague. Are you able to state that with the new technologies now available, a review of the exclusion criteria is now justified? Is Health Canada studying alternative criteria or do you believe that science dictates that we remain conservative and continue to exclude people who have had homosexual relations during the past 25 years?

[English]

Dr. Peter Ganz: Certainly we are very cognizant of changes in technology. As Dr. Cameron indicated earlier, technology is evolving. The technology for testing for infectious disease is evolving, and we are following that very closely, as are the operators. Indeed, as is the case for NAT testing for HIV and HCV, when those technologies are reliable then we certainly are looking at having them introduced.

[Translation]

Mr. Réal Ménard: That was not my question. By the way, it's you, is it not, who establishes the criteria for granting a license to Héma-Québec or to the Canadian Blood Services? You are the regulatory organization. You answered that you are following technology, I should expect so, but at this time, are you, as a regulatory centre, able to propose any alternative criteria, or, because of the fact that you are also linked to the FDA, do you believe the opposite, that no alternative criteria can be proposed, and that you would be quite uncomfortable considering criteria from a committee such as this, where we to be reckless and come up with some other criteria? Do you anticipate a conservative approach in the coming years or do you think that there is an opportunity for change?

[English]

Dr. Peter Ganz: We're certainly very interested in the consensus conference that the blood system operators are planning. We're certainly interested to participate in that conference and listen to the discussions and the science that will be presented, which I think may allow us to consider some changes to the—

[Translation]

Mr. Réal Ménard: I am the politician and yet you are the one not answering questions. We will hear from your colleagues to see.

[English]

The Chair: Excuse me, Mr. Ménard. Maybe I can help you out.

We have Health Canada here; we have the administrators of the blood system here. Just supposing the Minister of Health wanted to change the questionnaire, who does it? Is it Health Canada, or is it this group? This whole thing is becoming fuzzy, with the idea of this consensus conference, which, it seems to me, delays the whole thing ten months, and then you hope there's some resolution coming out of it, that there's some consensus. If there is a consensus, who then drives the process to get the questionnaire changed?

• 1215

Dr. Graham Sher: Perhaps I can begin to answer that, Madame Chair.

As the operator of the blood system, we are certainly free to recommend changes to the questionnaire, and we do that all the time. We have an active, ongoing joint working group of CBS and Héma-Quebec that reviews every criterion concerning donor screening. We have a thick binder of criteria that address the safety of donors and the product. We do make recommendations to change it on a regular and ongoing basis. In order for the changes to be implemented, they require the approval of Health Canada. The operators are certainly free to and do make suggestions to change the screening process all the time.

The Chair: Take the last set of recommendations you gave to Health Canada, did they implement them?

Dr. Graham Sher: Yes. We used to defer people as blood donors who took anti-hypertensive, or blood pressure, medication. We produced a document for Health Canada showing, with all reasonable data, that this did not impose any safety risk on the donor or the recipient. We requested of Health Canada that they drop that criterion. They approved that request.

The Chair: Okay. Was there any change to the questionnaire as a result of that?

Dr. Graham Sher: There was change to the screening process, because the questionnaire is only one part of the screening process. It asks you whether you take any medication, and in the manual it said that this medication was a reason for deferral. We got that changed. That's one example of many hundreds of criteria.

[Translation]

Mr. Réal Ménard: Will the introduction of PCR technology allow for possible changes with respect to question 17, with respect to exclusion? As the regulation centre, you will want to have as much scientific evidence as possible. No one here around this table doubts that, but what should be done with a situation that is very discriminatory towards one group in society in particular?

Dr. Marc Germain: Let us phrase the question somewhat differently: does the fact that we now have a PCR test or nucleic acid tests for HIV or for other viruses mean that the questions on the blood donor form can be changed? It is a question well worth asking, but before saying whether or not we can change the selection criteria for men who have had homosexual relations, we need to examine the situation in detail, and take into consideration this new information. What I can tell you is that, in and of itself, the nucleic acid test for HIV is certainly not sufficient reason to sign a death warrant on that question which is currently on the form. It's much more complex than that. We need to assess other factors in the equation.

I would like to come back to a couple of points that were mentioned, among others by Dr. Hindieh and Dr. Cameron. We have to consider not only the reliability of tests, but also the entire selection and qualifying process for blood products, the margin of error in carrying out tests, and the imperfection in test sensitivity. No matter what new tests are used, test sensitivity is never the magic 100%. So, we must consider all of these new factors and see if the simple fact of introducing a new test based on a more sensitive technique justifies reviewing the criterion in the blood donor questionnaire.

[English]

The Chair: Excuse me, Mr. Ménard.

Mr. Réal Ménard: You are very generous. I love you.

The Chair: This is not winning me any affection from this side, unfortunately.

Do we have a quick question on this side? Madame Scherrer.

[Translation]

Ms. Hélène Scherrer (Louis-Hébert, Lib.): My questions are along a similar line, anyway. What I really want to understand, quite specifically, is this. If I understand correctly, at the outset, the tests that were in place were such that they were not safe because there was a window of approximately three months which meant that we were not able to determine if a person was infected or not. The new tests we are talking about reduce the window but cannot reveal, at the moment when the person gives blood and at the moment when the sample is given for testing, if that person is in fact infected.

Dr. Marc Germain: That is one aspect of the question; the new tests that have been introduced aim to reduce what is called the window period, whereas with the tests that were being used until recently, in theory donors who had been infected recently could go undetected. This new test—and this is the reason why it was introduced—reduces this window of opportunity, thereby further reducing the risk of introducing a contaminated unit into the system.

• 1220

However, this is not the only factor that can lead to the risk of introducing a contaminated unit into the system, and this is what is important. In other words, the new test that was introduced further diminishes the residual risk, which is already minute, but in and of itself, it does not bring it down to zero; it will never reach zero. There are other factors to consider.

Ms. Hélène Scherrer: If you could reduce the window with a test that would allow you to determine if a person is infected at the very moment they give blood, then at that time, I think that we could think about removing some of the questions on the questionnaire.

Dr. Marc Germain: No. That is exactly what I am trying to tell you. The test that has just been implemented reduces the window period to virtually zero, but that is not true, there still remains a small fraction of a chance. Even if we could bring this window period to zero, there are still other factors that would make it difficult to justify or easily defend any move to simply scrap not only the question on homosexual men, but all of the questions that are found on the questionnaire.

Ms. Hélène Scherrer: That would be the case then, even with a very reliable test.

Dr. Marc Germain: That would be the case, even with perfect tests.

[English]

Dr. Graham Sher: There's perhaps one more important point to add to that. You can only test for viruses you know about, and the screening questionnaire asks, for example, questions about intravenous drug abuse. We know there are likely vehicles of transmission for viruses we don't know about. That route in the screening questionnaire, in all likelihood, contributes to eliminating or reducing risk from viruses for which we do not currently test. So it has a dual function, dealing both with the viruses we know about and also the viruses we don't test for.

[Translation]

Ms. Hélène Scherrer: I have one last quick question.

I think that one of your objectives, whether it be Héma-Québec or the Canadian organization, is that of safety. You are responsible for ensuring safety. You ensure that the recipients and the donors are very well served. I think that there is one element that we often forget: you no doubt also have the responsibility of ensuring that your blood banks are always very well stocked and there is what amounts to an advertising campaign to do this. It is this element which, for me, becomes almost problematic, because you must not only ensure that the number of donors does not diminish, but you must also ensure that there are always a great number of people to supply your blood banks. Thus, this can also be very problematic because you must advertise and go and find new donors all the time.

Dr. Marc Germain: That is precisely the reason why we cannot exclude, at the outset, all persons who might be at risk of some infection. That would be tantamount to saying that we will no longer have any blood in reserve because we would be excluding everyone, the entire population. Everyone is potentially at risk for some infection or other.

So, the challenge for us is to identify the most "efficient" way, to come back to Dr. Cameron's expression, to reduce the risk without endangering our supply, in other words eliminating groups of people who are at higher risk, as groups, not necessarily as individuals, but without at the same time shooting ourselves in the foot at point blank by eliminating 50% of the general population.

This is the type of risk and benefit that we need to take into consideration, and in the specific case of the criterion for exclusion of homosexual men, this is one of the aspects to consider; I mentioned it. Would the benefit stemming from a softening of the current policy outweigh the risk of introducing contaminated units into the blood system? That is a significant part of the equation, indeed.

To answer your specific question on the assessment, very briefly, I can tell you that the assessment process is underway. We expect to present our first official findings to the international scientific community next June and it is likely then that the results will become public, and they will certainly be available for the consensus conference in November. However we must not expect that all of the answers will be found in this assessment. For now, the only specific question that we are looking into is that of HIV.

We have not yet dealt with other infections: unknown infections, the fact that certain groups may be at risk for other unknown infections. As I mentioned, it is a very complex issue.

• 1225

In any case, these preliminary findings may help with the discussion, in the next two or three months.

[English]

The Chair: Thank you, Mr. Germain.

I'm going to have to close off this section of the meeting now. I want to thank our panellists for coming and sharing with us. We may want to invite them back to talk about this further. Thank you for coming today.

[Translation]

Mr. Réal Ménard: I have a point of order, Madam Chair. Will you ensure that Health Canada will produce a document for us on the conditions for granting a licence and that we will obtain from the other two witnesses the list of tests, their scientific value, who they screen and what purpose they serve. This will be important for the report.

[English]

The Chair: I think the clerk took note of this.

The Clerk of the Committee: We will follow up on all the promises to produce.

The Chair: Thank you very much.

We will now invite to come forward Dr. Robert Remis, Dr. Don Kilby, Dr. Alan Lane, and Eric Maurier.

I want to thank you for your patience and apologize for the length this meeting has taken, but we are a new committee, for one thing, and we're just feeling our way about how much we can fit into one meeting. I think today we've learned that this is too much. So unfortunately, you've had to sit there and wait. I'm sorry about that.

I think we'll start with Dr. Remis from the University of Toronto, please.

Dr. Robert Remis (Associate Professor (Epidemiological Consultant to the Canadian Red Cross 1988-1996), Department of Public Health Sciences, University of Toronto): Thank you very much for inviting me this morning to present to the Standing Committee on Health.

The issue of blood-borne infection and HIV is one I've been interested in for a long time. In this capacity, I'm not representing the University of Toronto or the Department of Public Health Sciences, but rather reflecting on some of my experience in this area. I do have a brief that reflects some of what I'm going to say, if you want to pass it around.

In 1987 I was kindly invited to head up an investigation into a cluster of HIV infections among hemophiliacs in British Columbia. Subsequently I worked as a consultant in epidemiology to the Canadian Red Cross from 1988 to 1996. I also have worked as an expert witness extensively in both Canada and the United States, both for the plaintiff and the defendant, in issues related to HIV, with respect to blood transfusion and factor concentrates. Finally, I have carried out studies under contract from Health Canada and from the Commission of Enquiry into the blood system, on HIV as related to blood transfusion, and also on Hepatitis C as related to blood transfusion. So I've had experience over the past 14 years in this area.

• 1230

Getting to my actual text, clearly, modifying the current policy according to which blood donors are recruited and the implementation of this policy has potentially important implications for both the adequacy and the safety of Canada's blood supply.

To date, Canada has one of the best volunteer blood agencies in the world. This is despite deficiencies identified through the commission of inquiry, including the failure of effective application of blood donor deferral policies from 1983 to 1985 and the slowness to implement routine HIV screening of blood in 1985.

Clearly, men who have sex with men—and I will refer to them as MSM, as we do in our epidemiologic jargon—have been seriously affected by the HIV epidemic and have experienced a high rate of HIV infection compared to other men in Canada. Overall the prevalence of HIV infection among MSM is estimated to be in the range of 10%.

Approximately 30,000 of the estimated 290,000 MSM in Canada are thought to be infected with HIV. This is almost a 300-fold greater prevalence than that among non-injection drug using heterosexual men, whose HIV prevalence is likely in the range of 0.04%. So we're talking about a relative risk in the range of 300, and for HIV incidence, the situation is comparable.

I think there are two issues here that maybe I can clarify, moving away from the text.

We talked about the window period and the tests in the window period, and then we talked about HIV-infected units in the system. I think that's a good way of thinking about it, the problem of incidence and the problem of prevalence. In other words, what is the problem of not detecting a unit that is in the window period before a marker has appeared—which was the subject of some discussion a few moments ago—but also, what is the risk involved with identified HIV-prevalent units that could potentially be transfused in error or because of urgent requirements for these units? The latter point is something that I want to clarify more.

I will not address at length here the issue of equity or human rights. It does not appear to me that there is any inherent right to give blood, unless the exclusion is arbitrary or based solely on unjustified discriminatory considerations. However, I will leave these legal and ethical considerations to others.

The two important epidemiologic issues, among others, that I will discuss briefly today are the following: Will the inclusion as blood donors of MSM who have abstained from sexual contact with other men in the previous year increase the risk of transmission of blood-borne pathogens in general and HIV in particular, and thus reduce the safety of the blood supply, and secondly, to what extent would inclusion of these men who are currently deferred increase the number of potential donors and thus help to ensure the adequacy of the blood supply?

With regard to the former, it is unlikely that a donor infected with HIV through sexual contact with other men more than one year ago would still be in the so-called window period. As was already pointed out, the current ELISA test is very sensitive, and the window period is likely in the range of three weeks and probably no more than three months.

I wasn't aware of the new data cited by Dr. Sutherland about the potential interaction between HCV and its potential suppression of the production of antibodies, so this should be taken into consideration as well. But in general, the window period is thought to be, at maximum, three to six months, therefore the risk of someone who did not have such an exposure in the previous year related to the window period would likely be very low, if not zero. Let's just say negligible, maybe not zero.

However, an important concern with respect to risk is the introduction of HIV positive units into the blood system, which is what I was taking about earlier, the prevalent cases. In my opinion, given the small but real possibility of laboratory error and the exceptional use of untested blood in emergency situations, the probability of the transmission of HIV would likely increase if we brought this new group in as blood donors.

It is difficult to estimate the prevalence of HIV in a homosexual population that has been sexually abstinent for one year. HIV prevalence among MSM who believe themselves to be negative was about 1.5% in Montreal, according to data from the Omega cohort study. This may be somewhat higher than for a population that has abstained for at least one year, and I believe it's plausible—although this is only speculative, but it's a range—that the likely prevalence in that group who would be brought in as blood donors would be in the range of 0.5% to 1%, in other words, somewhat lower than the 1.5%. This is clearly much lower than the overall HIV prevalence among MSM in general, which I've estimated at about 10%, but much higher than the prevalence in heterosexual men, as I noted above, about 0.04%, and markedly higher than the current prevalence among male donors. This is data that was kindly provided by Dr. Sher.

• 1235

In the first nine months of 2000, HIV prevalence—that is, actually identified units—among men who donated blood in Canada through the CBS was 0.0006%. There were in fact two positive units among 337,000 male donors who donated from January to September 2000.

Overall, of the approximately one million units collected per year in Canada, from four to eight units have been HIV positive in the past five years, so the prevalent rate is actually extremely low. In fact, in the past two years, there have only been four cases per year, as best as I can determine, compared to about seven or eight in the previous three years before that. So the number of actual prevalent units being identified and coming into the system is very low.

If we assume that 5% to 10% of the approximately 290,000 MSM in Canada have been abstinent for the previous year, which is data from a Toronto study carried out several years ago, and then in general, 4% of men donate blood in any given year, based on Canadian and Quebec data, we would expect that a new policy such as that proposed would result in approximately 600 to 1,100 additional units per year. This would result in an increase of less than 0.1% in the number of available units in Canada. So the benefits of bringing in this group in terms of actual additional adequacy would be negligible.

We would expect that among these 800 or so units, approximately four to eight would be HIV positive, due primarily to sexual contact before the previous year. Thus, this would double to triple the number of HIV positive units in the blood collection system, and therefore double to triple the potential risk due to laboratory error and the emergency use of untested units. Admittedly, the absolute number of additional transmissions would be relatively low due to the low lab error rate, but the relative risk would be two- to threefold.

Thus, in summary, it seems likely that a change in policy on blood donors to recruit MSM to donate blood if they abstain from sex in the previous year would increase the risk of HIV transmission more than twofold, with a negligible increase in the adequacy of the blood supply. On this basis, I believe from an epidemiological perspective such a change in policy is not desirable.

The Chair: Thank you for being so clear.

Dr. Kilby.

Dr. Don Kilby (Director, Health Services, University of Ottawa): Thank you for inviting me today.

I have a different perspective as a primary care physician, a family physician, who works out of the University of Ottawa health services and cares for approximately 400 patients with HIV.

In an effort to ensure the safety of the Canadian blood supply at a time when little was known about HIV and at a time when no diagnostic tests were even available, men who have sex with men were excluded, based on their sexual orientation, from participating in blood donation programs. This policy was based on the best public health advice available at that time, given the technology that was available and given what we knew about this epidemic.

Today we can say that Canada has the safest possible blood supply, relying more heavily on more advanced technology to ensure the safety of donated blood products. But this occurred in the first wave of the epidemic, in the height of the epidemic when we made these decisions, and now we have gone through a second wave of the epidemic. Some would argue that recent data would suggest, at least in certain populations in this country, that we are in a third wave of the epidemic, led by a heterosexual spread.

So I think it's appropriate that the Commons' Standing Committee on Health review the Canadian Blood Agency's guidelines that exclude donors based on sexual orientation. The epidemic has predictably shifted, and there are fewer new cases of HIV among men who have sex with men. There has been a shift in the last year, which we can directly attribute to the changes in prevention programs, and the shifting of funds towards treatment and care and away from prevention. But certainly if we look at the overall changes over the last 10 to 15 years, there has been a drop in the numbers of men who have sex with men who have become HIV infected, and there is a growing number of cases of HIV among heterosexual men and women. We can't ignore that fact, and we can't ignore what that's going to mean for the future. So clearly being homosexual or being heterosexual does not in itself determine a person's risk for HIV, and rather, the risk of HIV is determined by an individual's sexual practices, not their sexual orientation nor their country of origin.

Exclusions based on sexual orientation will become more and more difficult to sustain in the coming decades as the HIV demographics of the epidemic shift. If HIV were to become as prevalent among heterosexuals as it has become among homosexuals, it would be difficult to apply today's rationale, and we wouldn't be able to apply it in order to exclude contributions to the emergency blood supply of this country.

• 1240

So as we can be more confident about our blood supply today, we should be more confident not because we continue to exclude self-avowed homosexuals, but because tests available to screen for HIV are more sensitive and more comprehensive. We had no tests when we put this policy in place. We also have to remember what Dr. Cameron spoke about, the altruism of people. It was the altruism of people who donated to the blood supply that in some ways created the problem we had. They did not do this willingly. They did not do this knowingly. They did this in a time before we even knew HIV existed. That altruism to refrain from donating blood is still part and parcel of the Canadian fabric and about Canadians in general and homosexuals in particular.

We've also, as we've heard, trimmed down the time between acquisition of HIV and its detection to approximately two and one half weeks. However, to reverse a decision taken early on in the epidemic that would exclude homosexuals might not be the most politically safe action to take. Many Canadians would not be reassured, but I think we have to be clear that a lot of this fear would be based on homophobia. The present policy has only served to reinforce that homophobia, and does not address the true determinants of risk that could jeopardize our blood supply and ensure its adequacy in the years to come.

Exclusions need to be based on behaviours, on risk activities that could compromise an individual's health and personal risk of acquiring HIV. Exclusion from donating to the blood supply should not be based on who you are or where you came from. Even before men who have sex with men learned about HIV and the way it was spread, many gay men did not engage in behaviours that put them at risk for HIV. Even more homosexual men today have adopted safer sex practices. A policy that excludes homosexuals only reinforces the myth that all gay men pose a threat to our blood supply.

I'm not aware of any Canadian policy at present, although I believe one will soon be drafted that may provide exclusions, that rejects organs donated by gay men. Screening interviews and blood testings are used to determine the suitability of an organ that's being used for donation. It's probably an area, because of the shortage we have of organs in this country for transplant, where gay men can still make the gift of life. If the Canadian blood supply has similar shortages, it would have to reconsider its exclusion criteria and improve, if it were at all possible, its screening test to ensure the greatest participation possible.

I think it's appropriate at this time that this committee look at this question and that the Canadian Blood Services look at existing exclusion criteria and review these, and that any reference to sexual preference be removed. New screening guidelines should be based on specific risk activities and the timing of these activities. This would allow for the maximum number of Canadians to benefit from and contribute to the Canadian blood supply without further marginalizing groups of Canadians.

The Chair: Thank you, Dr. Kilby.

We have two representatives from Roche Diagnostics and I don't know which one of you is prepared to speak. Is it Mr. Maurier or Dr. Lane?

Mr. Eric Maurier (Manager, PCR Technology, Roche Diagnostics): Thank you for inviting us there today. We as a company are supplying the assay to both Héma-Québec and the Canadian Blood Services in investigational testing applications. We're here today to answer any questions you would have regarding the assay.

The Chair: Thank you very much.

Do we have questions? Mr. Ménard.

[Translation]

Mr. Réal Ménard: I have a couple of questions. In order to avoid confusion, I'll ask my questions first to the representatives of Roche Diagnostics.

Please tell us what you can about the window of opportunity and the scientific investigations that have been done on the serodiagnostic test that you are preparing to market, and which is already even partially marketed?

[English]

Dr. Alan Lane (Head, Clinical and Regulatory Affairs, Roche Diagnostics): The test has been under investigation in the U.S. for about a year now. They have probably screened somewhere in the neighbourhood of about 4 million or 5 million units of blood. During that period of time, they have been able to identify one unit where the patient had not sero-converted; in other words, the antibody was not present but they identified that the virus was present in the blood. In the U.S., it is still under investigation as well. A lot of work needs to be done.

[Translation]

Mr. Réal Ménard: The test you are referring to, just so this is clear to everyone, is in fact the PCR test?

[English]

Dr. Alan Lane: It is the PCR test, yes.

[Translation]

Mr. Réal Ménard: You said that in the United States, this test is currently being studied. This test is therefore not being used yet in Canadian blood banks, is that right?

• 1245

[English]

Dr. Alan Lane: We've just initiated this particular test for HIV testing at Héma-Québec and we're about to initiate it at CBS. This is being done with the approval of the Medical Devices Bureau of Health Canada.

[Translation]

Mr. Réal Ménard: Earlier, scientists stated that, for all intents and purposes, the window of opportunity, in which the presence of antibodies cannot be detected, would be reduced to virtually zero. Would you support a statement such as this? Perhaps Dr. Remis could react to this. I remember, from when he used to work for Cohort Oméga, that he is a very conservative scientist. Perhaps you could give us some idea of what we can reasonably expect in terms of your test being operationalized when it comes to closing this window of opportunity?

[English]

Mr. Eric Maurier: This assay is currently under investigational testing and we believe that it will reduce the window period for HCV from 60 days to approximately 30 days. So you'd have 30 days where the donor could be potentially infectious.

For HIV this window case could be reduced from 21 days to somewhere between 15 and 16 days, so you'd still have two to two and half weeks where the donor could be potentially infectious.

[Translation]

Mr. Réal Ménard: Do you agree or do you disagree?

Dr. Robert Remis: You mentioned that there was hope that these tests could reduce the window to zero. I would like to respond to that statement. Based on current knowledge, it is impossible to reduce it to zero. We are talking about reducing it by a few more days, but never reducing it to zero, thus from 21 days to 16 or 17 days, but never to zero.

Mr. Réal Ménard: I understand what you said. I agree. I didn't express myself clearly. I am sorry.

The fact that the PCR test will soon be marketed and the fact that different license holders will have access to it give us hope.

To return to your calculations, Dr. Remis, you start with the premise that, according to a Toronto study, there are 280,000 homosexuals in Canada. According to you, 4% of this sample could give blood, according to the models...

Dr. Robert Remis: That is based on overall national rates.

Mr. Réal Ménard: Thus, for the purpose of information, 4% of Canadians give blood, is that right?

Dr. Robert Remis: Between 4 and 5%, approximately. Yes, that's right.

Mr. Réal Ménard: Perfect. That is one question that we had.

Dr. Robert Remis: That is per year.

Mr. Réal Ménard: That is on an annual basis, fine. Therefore, that would be approximately 1,000 supplementary units of blood.

Dr. Robert Remis: Approximately, yes.

Mr. Réal Ménard: In your opinion, that would not change things much. The cost-benefit would not cause you to recommend the policy change since 1,000 units of blood, after all, is marginal when compared to the changes that we are talking about making.

Dr. Robert Remis: Obviously, there needs to be further analyses to see the limits of our calculations. We have yet to do this. Therefore, each estimate is subject to a certain amount of uncertainty which I have not yet incorporated into the calculations. But, by and large, that is it.

Mr. Réal Ménard: Among Canadians currently, less than 4% of the men give blood, is that correct?

Dr. Robert Remis: Yes, that is about right.

Mr. Réal Ménard: As for the general population, is it...

Dr. Robert Remis: Those eligible are adults aged 18 to 59, if I am not mistaken. Therefore, we are talking about approximately 20 million adults in Canada. Thus, there are probably between 400,000 and 500,000 people, approximately, who give blood in any given year.

Mr. Réal Ménard: I have one last question, Madam Chair. I have got the impression that you are about to interrupt me.

Dr. Kilby made an extremely interesting presentation. He made a comparison that no one else made, a comparison which is thought- provoking. He said that gays could donate organs, but that they could not give blood. What does this suggest as a comparison? Obviously, I understand that the risk coefficient is not the same. But, what were you trying to have us understand in making this type of comparison, Dr. Kilby?

Dr. Don Kilby: The point that I wanted to raise, is that obviously, when you are in a situation where there is a shortage, in other words, there are not enough units of blood because there are not enough donors, you want to increase the number of donors. What Dr. Remis is trying to say is that even if we change the exclusion criteria, the number of additional units available for Canadians would be quite minimal. This is not the case for organs, no doubt, because there is a real shortage of organs. Therefore, each organ is considered very important and precious.

• 1250

Mr. Réal Ménard: Dr. Remis' hypothesis does not take into consideration the fact that Héma-Québec and the Canadian Blood Services are now showing that they have incredible imaginations—they are using aggressive strategies, positively aggressive. In the subway and elsewhere, their advertising campaign invites people to give blood and they allow us to put a name to the picture of a young girl that appears in the ads on the metro and that explain why it is important to give blood. The campaign is very human. That 4% rate may well increase if these ads have an impact.

Dr. Robert Remis: Yes. That's right, over the past three or four years, the number of units collected and administered in Canada has risen by 10 to 15 per cent. About four or five years ago, there was a drop, but things are starting to pick up again now.

Mr. Réal Ménard: Dr. Kilby's statement is also interesting. He stated that the epidemiology and the profile of infected people is changing. Health Canada reported this change earlier. These people are now mainly men. Perhaps that depends on the sample. As far as you're concerned, and you have concentrated on Toronto and Montreal, do you think, that on a national scale, we could say that those who are infected with AIDS are mainly intravenous drug users? If you look at things that way doesn't that bring us to a different conclusion? If in fact this is the case and given the current, unreported state of this epidemiology, do you think that the questionnaire really provides us with the basis for the required safety features?

[English]

Dr. Robert Remis: I want to make something very, very clear: I disagree with what Dr. Kilby has said on epidemiologic grounds. It may be true that there is some increase in HIV transmission among the heterosexual population, but this is at a very...

First of all, I'm not sure that it is true. A lot of the women getting infected are in fact injection drug users and sex partners of injection drug users, who would be picked up through a questionnaire.

Second, even if it were true, we're talking about a 300-fold difference in risk. If you have an increase of 20% or 30%, even according to the federal figures, the increase is roughly equivalent among heterosexual transmission and transmission among MSM, but at a level that's 200- to 300-fold greater. We're still talking about a differential of risk that, instead of being 300-fold, is 250-fold.

So I disagree entirely that there's any kind of crossover or approaching at all the level of either prevalence or incidence in a heterosexual population as compared with the homosexual population, where the relative risks are still several hundred-fold.

Dr. Don Kilby: I just want to remind Dr. Remis of his own publications on endemic populations in terms of looking at heterosexual risk. If you start to break down heterosexual risk into different populations, you may well find that in certain populations, in particular in certain endemic populations, and certainly those he studied, there are epidemics within the epidemic.

If we're going to apply yardsticks, I think we should have integrity in this country and apply them equally. If we're going to apply them to gay men, we should apply them equally to other groups and other populations that may be at risk.

Dr. Robert Remis: Dr. Kilby brings up a very good point, and I agree, actually, even though it's not the subject of discussion this afternoon. There is a subset of persons from sub-Saharan Africa and the Caribbean who are at 40- or 50-fold the risk of Canadian-born persons with the same kind of profile.

Behaviour is not the only indicator, by the way, of HIV risk. Behaviour is a simplifying assumption that people make, but it's not only what you do that indicates your HIV risk but also with whom you do it. If your partner happens to expect a prevalence of 3% to 5% instead of 0.001%, then of course your likelihood of being infected will be far greater. For example, studies in Africa have shown a woman with only one sex partner in her life has a prevalence of 25% to 30%. Clearly it's not simply a reflection of risk behaviour.

So this is another group that I think also deserves some kind of reflection. I'm not sure what the current policy is, but it is an issue about which I was actually quite concerned several years ago, I believe.

[Translation]

Mr. Réal Ménard: Madam Chair, do I have time to ask one brief question?

[English]

The Chair: Madam Sgro has been very patiently waiting here. I'd ask you to defer to her, please.

Mr. Réal Ménard: Thank you.

Ms. Judy Sgro: Dr. Kilby, I'm sure you must be very interested, as we all are, in making sure our blood supply is as safe as can be. Are you supportive of a change in the blanket exclusion that currently exists in our system?

Dr. Don Kilby: I think this has to be a period of dialogue, and we have to be prepared to look at it. We have to be prepared to discuss it. We have to be able to do this openly in this society.

Although I hadn't been aware of this, at least some type of consensus meeting is going to occur. This is an opportunity to talk about it. I think decisions were made prior to a time when we even knew what the organism was that caused HIV. We had an idea that it was sexually transmitted, we knew it was principally among homosexual men, and we made a decision at that time.

• 1255

I think it's time to come back and look at the decision. We may come out at the end and decide on the same criteria. When we do so, we should ask Health Canada, our statisticians, and epidemiologists to use yardsticks that will determine when groups, communities, and people who belong to groups and communities in this country will no longer be able to contribute to the blood supply of this country because there is added risk because of the group they belong to, not the activities they're embarked on. I think we now have one group.

As Stephen Owen pointed out, what are we going to do about the reality of people coming from endemic areas? If you come from this country or that country, or if you travel in this country or that country and have lived there for so many years, do we have the stomach to start excluding these people from contributing to our blood supply? This epidemic is shifting. There are realities around the world different from our own reality. They were not taken into consideration when we first created these exclusions.

Ms. Judy Sgro: The basic premise here is the safety of our blood supply—

Dr. Don Kilby: Absolutely.

Ms. Judy Sgro: —and everything that we have to do to ensure it, regardless of what group you come from or what behaviour you might add.

In the essence of time, I won't go on here because there's no time left. Thank you.

The Chair: Thank you very much to my colleagues for their attention. It has been a long sitting.

Thank you very much for your patience in waiting to present to us and for the clarity of your presentations. We reserve the right to perhaps call you back if we get into this subject again.

Ladies and gentlemen, my colleagues, we did have a motion here about a budget, but we seem to have lost quorum so we can't proceed.

I have one other item of business for you. It has been brought to my attention that there is a particularly interesting meeting on Thursday, April 5, from 10 a.m. to 12 noon. There is a group of experts on this human genome project, “Science, Ethics and Business of the Genetics Revolution”, with Dr. Thomas Hudson, Dr. Arthur Hanson, and Dr. Martin Godbout. Preston Manning is putting this on. He has invited members of the Standing Committee on Health and the Standing Committee on Industry because both committees will be grappling with this particular subject.

I had the clerk phone the Health Canada people, who were to take us through the plans and priorities document from 11 a.m. to 1 p.m. They can do it in an hour, so I was wondering how you would feel about changing that meeting to begin at 12 noon. This particular presentation is in Room 200, West Block, from 10 a.m. to 12 noon. We could meet from noon to 1 p.m. in the second of our regular hours to hear from Health Canada.

Would you be agreeable to that change?

[Translation]

Mr. Réal Ménard: Yes.

[English]

The Chair: It doesn't mean you have to go, it's just an opportunity for you.

The other place you might catch these same people is at the Bacon and Eggheads' breakfast, where the main speaker, Dr. Thomas Hudson, is also speaking in the parliamentary dining room from 7:30 a.m. to 9 a.m. on Thursday.

You could see him from 7:30 to 9 a.m. or you could wait till 10 o'clock, go to Room 200 to hear three of these people, and then come here or next door for noon. I'll have the clerk send out a notice on the change of time. We'll meet as a committee at noon on Thursday.

I would remind you that we have the Canadian Food Inspection Agency coming tomorrow afternoon. This is an extra meeting. You raised a lot of questions about their role in a variety of things, from foot-and-mouth disease to approvals and how they work. At 3:30 p.m. on Wednesday, we have the Canadian Food Inspection Agency.

At noon on Thursday, we'll meet with Health Canada for the plans and priorities, which is the first step in the estimates process.

Then you have the option of when to see Dr. Hudson, either at breakfast or at 10 a.m. in Room 200.

Are there any questions?

Ms. Judy Sgro: We're not meeting on Thursday afternoon?

• 1300

The Chair: We never meet on Thursday afternoon. We're meeting from noon until 1 p.m. on Thursday and tomorrow afternoon at 3:30.

Thanks very much, people.

The meeting is adjourned.