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37th PARLIAMENT, 2nd SESSION

Standing Committee on Health

EVIDENCE

CONTENTS

Wednesday, February 19, 2003

1535

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

Dr. Graham Sher (Chief Executive Officer, Canadian Blood Services)

1540

1545

The Chair

Dr. Francine Décary (Executive Director, Héma-Québec)

1550

1555

The Chair

Ms. Julia Hill (Acting Director General, Biologics and Genetic Therapies Directorate, Health Products and Food Branch, Department of Health)

1600

Mr. Réal Ménard (Hochelaga—Maisonneuve, BQ)

Ms. Julia Hill

1605

1610

The Chair

Mrs. Brenda Chamberlain (Guelph—Wellington, Lib.)

The Chair

Mrs. Brenda Chamberlain

The Chair

Mrs. Carol Skelton (Saskatoon—Rosetown—Biggar, Canadian Alliance)

Ms. Julia Hill

Mrs. Carol Skelton

1615

Ms. Julia Hill

Mrs. Carol Skelton

Ms. Julia Hill

Mrs. Carol Skelton

Ms. Julia Hill

Mrs. Carol Skelton

Ms. Julia Hill

Mrs. Carol Skelton

Ms. Julia Hill

Mrs. Carol Skelton

Ms. Julia Hill

Dr. Graham Sher

Mrs. Carol Skelton

Dr. Graham Sher

Mrs. Carol Skelton

Dr. Graham Sher

Mrs. Carol Skelton

Ms. Julia Hill

Mrs. Carol Skelton

1620

Ms. Julia Hill

Mrs. Carol Skelton

Ms. Julia Hill

Mrs. Carol Skelton

Dr. Francine Décary

Mrs. Carol Skelton

Dr. Graham Sher

Mrs. Carol Skelton

Dr. Graham Sher

The Chair

Mr. Réal Ménard

Ms. Julia Hill

Mr. Réal Ménard

Ms. Julia Hill

Mr. Réal Ménard

Mme Julia Hill

Dr. Francine Décary

Mr. Réal Ménard

Dr. Francine Décary

Mr. Réal Ménard

Dr. Francine Décary

Mr. Réal Ménard

Dr. Francine Décary

Mr. Réal Ménard

1625

Ms. Julia Hill

Mr. Réal Ménard

Ms. Julia Hill

Mr. Réal Ménard

Ms. Julia Hill

Mr. Réal Ménard

Ms. Julia Hill

Dr. Francine Décary

Mr. Réal Ménard

Ms. Julia Hill

Mr. Réal Ménard

Ms. Julia Hill

Mr. Réal Ménard

Ms. Julia Hill

Mr. Réal Ménard

Dr. Francine Décary

1630

Mr. Réal Ménard

Ms. Julia Hill

Mr. Réal Ménard

Dr. Howard Njoo (Director General, Centre for Infectious Disease Prevention and Control, Population and Public Health Branch, Department of Health)

The Chair

Mr. Stan Dromisky (Thunder Bay—Atikokan, Lib.)

Dr. Howard Njoo

Dr. Peter Ganz (Director, Biologics and Radiopharmaceutical Evaluation Centre, Biologics and Genetic Therapies Directorate, Health Products and Food Branch, Department of Health)

Ms. Julia Hill

Mr. Stan Dromisky

Dr. Graham Sher

1635

Mr. Stan Dromisky

Dr. Stephen Vamvakas (Executive Vice-President, Medical, Scientific and Research Affairs, Canadian Blood Services)

Mr. Stan Dromisky

Ms. Julia Hill

Mr. Stan Dromisky

Dr. Graham Sher

The Chair

Mr. Rob Merrifield (Yellowhead, Canadian Alliance)

Ms. Julia Hill

Mr. Rob Merrifield

Ms. Julia Hill

Mr. Rob Merrifield

Ms. Julia Hill

Dr. Howard Njoo

1640

Mr. Rob Merrifield

Dr. Howard Njoo

Mr. Rob Merrifield

Dr. Howard Njoo

Mr. Rob Merrifield

Dr. Howard Njoo

Mr. Rob Merrifield

Ms. Julia Hill

Mr. Rob Merrifield

Dr. Peter Ganz

Ms. Julia Hill

Mr. Rob Merrifield

Ms. Julia Hill

Mr. Rob Merrifield

Dr. Stephen Vamvakas

1645

Mr. Rob Merrifield

Dr. Stephen Vamvakas

Mr. Rob Merrifield

Dr. Graham Sher

Mr. Rob Merrifield

Dr. Graham Sher

Mr. Rob Merrifield

The Chair

Ms. Carolyn Bennett (St. Paul's, Lib.)

Dr. Howard Njoo

Ms. Carolyn Bennett

Dr. Howard Njoo

Ms. Carolyn Bennett

Dr. Graham Sher

Ms. Carolyn Bennett

Dr. Howard Njoo

Ms. Carolyn Bennett

1650

Ms. Julia Hill

Ms. Carolyn Bennett

Ms. Julia Hill

Ms. Carolyn Bennett

Ms. Julia Hill

Ms. Carolyn Bennett

Ms. Julia Hill

Ms. Carolyn Bennett

Dr. Howard Njoo

The Chair

Mr. James Lunney (Nanaimo—Alberni, Canadian Alliance)

Dr. Graham Sher

Ms. Julia Hill

Mr. James Lunney

Ms. Julia Hill

Mr. James Lunney

Dr. Stephen Vamvakas

Mr. James Lunney

Dr. Stephen Vamvakas

1655

Mr. James Lunney

Dr. Stephen Vamvakas

Mr. James Lunney

Dr. Stephen Vamvakas

Mr. James Lunney

Dr. Stephen Vamvakas

Mr. James Lunney

Dr. Stephen Vamvakas

Mr. James Lunney

Dr. Graham Sher

Ms. Julia Hill

Mr. James Lunney

Dr. Stephen Vamvakas

Ms. Julia Hill

The Chair

Mrs. Brenda Chamberlain

Ms. Julia Hill

Mrs. Brenda Chamberlain

Ms. Julia Hill

Mrs. Brenda Chamberlain

Dr. Howard Njoo

1700

Ms. Julia Hill

Mrs. Brenda Chamberlain

Dr. Graham Sher

The Chair

Mrs. Brenda Chamberlain

Dr. Graham Sher

Mrs. Brenda Chamberlain

Dr. Graham Sher

Mrs. Brenda Chamberlain

Dr. Howard Njoo

Mrs. Brenda Chamberlain

Dr. Peter Ganz

Mrs. Brenda Chamberlain

Dr. Peter Ganz

Mrs. Brenda Chamberlain

The Chair

Mrs. Brenda Chamberlain

Dr. Peter Ganz

Mrs. Brenda Chamberlain

Dr. Peter Ganz

Mrs. Brenda Chamberlain

Dr. Peter Ganz

Mrs. Brenda Chamberlain

Dr. Peter Ganz

Mrs. Brenda Chamberlain

Dr. Peter Ganz

Mrs. Brenda Chamberlain

Ms. Julia Hill

1705

Mrs. Brenda Chamberlain

Dr. Howard Njoo

Mrs. Brenda Chamberlain

Ms. Julia Hill

Mrs. Brenda Chamberlain

Ms. Julia Hill

Mrs. Brenda Chamberlain

Ms. Julia Hill

Mrs. Brenda Chamberlain

Ms. Julia Hill

Mrs. Brenda Chamberlain

The Chair

Mrs. Brenda Chamberlain

Ms. Julia Hill

Mrs. Brenda Chamberlain

Ms. Julia Hill

Mrs. Brenda Chamberlain

The Chair

Dr. Stephen Vamvakas

The Chair

Dr. Stephen Vamvakas

The Chair

Dr. Stephen Vamvakas

The Chair

1710

Dr. Stephen Vamvakas

The Chair

Dr. Howard Njoo

The Chair

Dr. Howard Njoo

Mrs. Brenda Chamberlain

The Chair

Dr. Howard Njoo

The Chair

Dr. Howard Njoo

The Chair

Dr. Howard Njoo

The Chair

1715

Dr. Howard Njoo

The Chair

Dr. Howard Njoo

The Chair

Dr. Graham Sher

The Chair

Ms. Julia Hill

The Chair

Dr. Peter Ganz

The Chair

Mr. Rob Merrifield

Dr. Graham Sher

1720

Mr. Rob Merrifield

Dr. Graham Sher

Mr. Rob Merrifield

Dr. Graham Sher

Mr. Rob Merrifield

Dr. Graham Sher

Mr. Rob Merrifield

Dr. Graham Sher

Dr Francine Décary

Mr. Rob Merrifield

Dr. Peter Ganz

The Chair

Mrs. Carol Skelton

Ms. Julia Hill

Mrs. Carol Skelton

Dr. Graham Sher

1725

Mrs. Carol Skelton

The Chair

Dr. Francine Décary

Dr. Graham Sher

The Chair

Ms. Julia Hill

Dr. Howard Njoo

Ms. Julia Hill

The Chair

CANADA

Standing Committee on Health

NUMBER 022

2nd SESSION

37th PARLIAMENT

EVIDENCE

Wednesday, February 19, 2003

[Recorded by Electronic Apparatus]

¹ (1535)

[English]

The Chair (Ms. Bonnie Brown (Oakville, Lib.)): Good afternoon, ladies and gentlemen. It's my pleasure to call this meeting of the Standing Committee on Health to order.

I would just like to alert both the committee members and the witnesses that there may come a moment at this meeting when we have a quorum. We need about three minutes to pass a budget. I may interrupt the actual substance of the meeting just for a couple of minutes to take care of that little piece of housekeeping. We don't have a quorum yet, but we have a sufficient number of members to hear witnesses.

We'll begin with that part of the meeting. I'll call on Dr. Graham Sher, the chief executive officer of the Canadian Blood Services.

Dr. Sher.

Dr. Graham Sher (Chief Executive Officer, Canadian Blood Services): Thank you, Madam Chair. Thank you for the opportunity to present before the committee.

I'm briefly going to walk you through a little bit of information. You have a deck of slides in front of you.

Briefly, just to remind you what Canadian Blood Services is, we are a national, independent, not-for-profit organization whose mandate it is to manage, collect, manufacture, and distribute blood and blood products throughout the country, except in the province of Quebec. We are also responsible for managing the Unrelated Bone Marrow Donor Registry here in Canada.

Here are some statistics to put it in perspective. We have over 40 permanent collection sites across the country. We collect blood from about 12,000 clinics on an annual basis, many of them run in all parts of the country. We collected just over 800,000 units of blood last year from an active donor base of over 450,000 Canadians.

We serve all the health care facilities outside of Quebec, which is at current count 855 institutions. About 125 Canadians each year receive transplants through the registry. CBS currently has about 4,500 employees and a large number of volunteers.

With respect to today's topic, here's a very quick synopsis on West Nile virus and what CBS is doing to protect the blood supply in that part of the country we're responsible for managing. In Ontario last summer there were 388 cases reported to CBS to date, of which 144 have been confirmed as West Nile virus. Over 200 still remain in the probable category, awaiting further diagnostic testing.

There were two cases reported from the province of Alberta, but a very important phenomenon is that both of them were acquired while on travel outside of the province. There were birds infected in the provinces of Nova Scotia, Manitoba, and Saskatchewan, but not in any of the other provinces in which CBS operates. Again, I would remind the committee I am talking about the statistics for the provinces in which we operate. My colleague, Dr. Décary, will give you the data for Quebec in a minute.

What has CBS done to date to protect the blood supply from the risk of West Nile virus infection? First, with all those cases I identified to you from Ontario that were brought to our attention over the last season, CBS was given the name of the individual by Public Health in each case.

We could do two things with that information: determine if that person had been a recent blood donor, and if so, if there was any inventory sitting on our shelves, we could immediately withdraw it; and determine if that person had recently received blood, so we would know whether potentially the West Nile virus had been received through a transfusion. Of the 380-odd cases, only one fit the category of a recent blood recipient. We worked very closely with Public Health to follow up on that case.

On November 8 last year, we were informed of a case of West Nile virus in a lady from the Kitchener-Waterloo area. It was thought she had acquired it through a blood transfusion. Indeed, this patient received 31 units of blood during a hospital stay. She did ultimately have a confirmed diagnosis of West Nile virus and died of what was likely the consequences of her West Nile virus infection.

The most current information is, as of today, we have managed to track the majority of those 31 donors, and one of them has in fact confirmed positive for West Nile virus, making this clearly a case of West Nile virus acquired through transfusion in Canada.

Again, just to put some important perspective on this, there are many cases now in the United States that are confirmed to be transfusion-related West Nile virus, at least 14 cases to our knowledge, and possibly as many as 40. I believe my colleagues from Health Canada will be providing more information in that regard.

In addition to working with Public Health, CBS undertook another major activity at the end of last year to protect the blood supply--the withdrawal of frozen products from our inventory. Because the mosquito-borne period over the summer resulted in the possibility of some components sitting in our inventory that may have been donated during the mosquito season, we took the opportunity to withdraw those products from our inventory when feasible, so they would not be transfused.

We had to withdraw the products that were frozen and still potentially sitting in inventory. That action was undertaken on December 12 last year, after we had made the necessary assessments that whatever product was going to be withdrawn from the system, we would have the capacity to replace it, because it would be very important not to withdraw blood products from inventory and then suddenly have no products to transfuse patients in need.

¹ (1540)

You can see in the CBS system that we have collectively withdrawn and discarded close to 7,000 components of plasma. This was material collected at the height of the season between the months of June and October 2002. I'm pleased to report to the committee that we worked to and have been able to replace all the withdrawn products, and no shortages occurred as a consequence of that action.

Perhaps more importantly, what are we currently doing to deal with the emerging threat for the next season? This information is provided on the next couple of slides. Our first action is currently stockpiling plasma over the winter months, because plasma has the capacity to be frozen and kept in inventory for up to one year, as is shown on the slide. This does not apply to the other major components we provide for transfusion, namely red blood cells and platelets, which only have very short shelf lives and can't be stockpiled. For this plasma, we are currently ramping our collections and undertaking a number of activities detailed on slide 13, to make sure we can collect enough plasma over the winter season to tide us over next summer, the next mosquito season, in the event we are unable to test for West Nile virus. Without going into a lot of detail, the actions we are currently taking are shown to the committee on slide 13.

We are also looking at other possible contingency plans to protect the blood supply for the coming season, including, for example, the possibility of collecting blood from certain parts of the country deemed to be low risk for West Nile virus, and using that blood for patients deemed to be at higher risk of possibly acquiring West Nile virus. Finally, as a contingency plan, we are looking at the possibility of a limited research-based test in our laboratory, should a routine blood screening test not be available, which I'll talk about in one minute.

On the future plans we're also looking at, there is one other plan we're examining at the moment, which is the importation into Canada of a product known as solvent-detergent-treated plasma. This is a special type of plasma that goes through a manufacturing process that effectively kills viruses, and renders the product free of viruses such as West Nile virus. Currently, there is no such product licensed for distribution in Canada. There used to be a U.S. manufacturer providing this material, which was licensed for distribution in Canada, but for a variety of market reasons the company ceased manufacture and distribution of the product last year. There were also a number of adverse complications in some patients who were using those products. There is a European manufacturer of solvent-detergent-treated plasma, not yet licensed for distribution in Canada. We are not aware, at this point, of similar adverse complications with that material, but we are actively studying the issue.

A very important point we would need to consider before making this decision is what the source of that material would be, because as I'm sure committee members are aware, Europe has been the source of variant CJD, or so-called mad cow disease. We would not want to trade that one risk off against possible protection from West Nile virus.

Finally, the most important matter I'm sure committee members would wish to be updated on is the implementation of a donor screening test for West Nile virus. In short, there is no screening test as I sit here and speak to the committee, but there is a tremendous amount of activity going on in North America, principally with two commercial companies seeking to develop an assay. In fact, we have made a decision on the vendor we are going with, and all plans are to have a test in place by July 1 of this year. There is an enormous amount of activity to be done between now and July. Both ourselves and the manufacturer of the assay need to get the necessary regulatory approvals; we need to design, renovate, and commission new laboratories; install and validate new equipment; train our staff and make sure they are competent in using this new assay.

I want to draw to the committee's attention the fact that putting a screening test in such a short order of time is an unprecedented scope and timeline of activity. I certainly want to acknowledge the enormous collaboration and support we have from Health Canada, our regulator, who has the same sense of urgency to get this in.

Finally, we're developing a detailed communication strategy to make sure all of the relevant stakeholders across the country are informed of the risks of West Nile virus and of what CBS is doing to protect the blood supply.

¹ (1545)

In conclusion, Madam Chair, just to draw to the committee's attention, certainly CBS views the emergence of West Nile virus as a very urgent issue, and we're being proactive in all our steps. I do want to credit again both Health Canada and Public Health in Ontario and the other provinces for extensive collaboration in this regard, as well as our ongoing collaboration with Héma-Québec.

We have taken a very open approach with the public and the media. We feel it is very important that the message be out there around the risks and what we're doing to mitigate those risks. We're obviously monitoring developments in the United States, where the epidemic was as large as if not larger than that seen in Ontario. As you can see, we are undertaking extensive contingency planning in the event a test is not available by the beginning of the mosquito season.

This is clearly the priority for CBS, as we speak, and all our actions are aimed, to the extent possible, at mitigating any risk of West Nile virus in the blood supply in the summer of 2003.

The Chair: Thank you very much, Dr. Sher. You've certainly given us a great deal of information in a very succinct fashion, and I appreciate it.

I'm going to give the floor now to Dr. Décary. Perhaps she can tell us if Héma-Québec is doing anything different, or how they are participating in all this.

[Translation]

Dr. Francine Décary (Executive Director, Héma-Québec): Note to Publications on affiliation: A hyphen must be added to Héma-Québec.

Good morning, Madam Chair. I'm going to alternate between English and French. I apologize for the fact that you have no brief in front of you. I didn't read the clerk's instructions when he summoned us. However, I will be sure to send it to you in the next few days. I would like to thank the committee for permitting Héma-Québec to present its plan of attack against West Nile virus infection in persons who have received transfusions. That plan will be implemented in summer 2003.

Héma-Québec is the blood supplier for Quebec. To give you some statistics, we received 250,920 donations during the 2001-2002 year. We called upon nearly 25,000 volunteers to organize our blood donor clinics; we organized approximately 2,500 clinics, both mobile clinics and clinics at fixed locations. We serve 112 hospitals in Quebec and we sent them nearly 387,400 blood products.

[English]

West Nile virus activity in Quebec in the year 2002 was a lot less than in Ontario. In Quebec, there were only eight confirmed human cases. There is still one probable, and 15 still under investigation.

The date of the first recorded case in Quebec was on July 2, 2002, and the last case was on September 29, 2002. We now know the peak incidence of the virus was during the month of August.

All cases were found in the southwestern part of the province: the Island of Montreal; the Island of Laval; the southern part of Montreal, that is, the Montérégie; and the southern part of the Laurentides and Lanaudière.

There were no transfusion-transmitted West Nile virus infections reported. There was one case where the patient had received some blood in the weeks before, but we were able to get in touch with the three donors, and none of them had any signs of infection with the West Nile virus, so this was not a transfusion-transmitted case.

There were, on the other hand, a lot of dead birds that were recorded, not only in the Montreal region but almost all over Quebec. So this really tells us how important the epidemics can be next summer.

You will see that the actions that were taken by Héma-Québec in 2002 were quite similar to those of CBS.

¹ (1550)

[Translation]

We worked in close cooperation with the public health sector and, in the same way, applied methods to exclude donors who might have been infected. As a result, we excluded donors in cases where infection was suspected, likely and confirmed.

But as you may have seen, very few of those cases arose, as a result of which we had very little to do in that area. We also applied a method that enabled us to conduct surveys in cases where a patient who had received a transfusion presented with a West Nile virus infection. However, as noted a moment ago, this kind of investigation for specific cases showed that donor test results were completely negative for West Nile virus infection.

Lastly, we were able to withdraw products in cases where we were informed that an infection had broken out as a result of a blood donation. We established a steering committee in early fall; that's what we also call a

[English]

West Nile virus steering committee, which was constituted at Héma-Québec in order to deal with this new pathogen.

Similar to CBS, on December 12 we also did a recall of frozen plasma products that had been collected between June 25 and October 6, 2002, and because we use a special production information system, we were able to retrieve the plasma from donors who were residing in the regions where human cases had occurred. So it was easier in some ways for us to pinpoint the donors who were at risk. Donors who had come from Montreal, Laval, Montérégie, Laurentides, and Lanaudière were the ones from whom we could retrieve the plasma. We identified, in that period, 9,620 frozen products, of which 589 were still in stock at Héma-Québec, so they were set aside. We had sent 9,030 to the hospitals, 704 of which were still in the hospitals, so they were retrieved from their inventories.

[Translation]

What was the impact of that recall? The impact was very minor. We were able to replenish the hospitals' inventories and we had no product shortages during that period.

So what's our action plan for next season? Our West Nile virus steering committee is still in place. We also decided to set aside frozen products for the summer period, and, on January 30, began to set aside what we needed. At the end of May, we will have set aside 25,000 frozen products, which can be distributed to the hospitals starting in June. We planned to be able to supply the hospitals with frozen products from June 1 to October 31, 2003.

We are exploring the possibility of having a question for blood donors. We don't think we will be able to find a question that will be that specific, but, in early May, we are going to conduct a donor survey to see and test a certain number of questions. May was chosen because that's obviously the time of year when mosquitos haven't yet appeared and so there's no chance of people developing symptoms as a result of a mosquito bite. We will be testing the question's specificity at that time.

We are also going to introduce a diagnostic test, that is to say a donor screening test, which is a nucleic acid test, and we have chosen Roche Diagnostics through a call to tender.

That's obviously our Plan A. Our Plan B will be implemented if we are unable to introduce the test to screen donors systematically. We are developing what we call an in-house test in research at Héma-Québec which would enable us to do a partial blood supply screening. Why a partial screen? Because we wouldn't be able to screen all donors systematically. However, we believe we would be able to screen part of the supply, which would enable us to offer certain patients at risk products that are negative for West Nile virus.

Like the Canadian Blood Services, we feel that the communication plan and public communication are really important.

¹ (1555)

[English]

We don't have other options in terms of collecting blood in other areas in the province, because as we've said previously, we have encountered dead birds with the West Nile virus all over the province, and we don't think there will be any corners of the province where they would not be at risk. Therefore, it is very important for us to make sure we have these tests in place before the mosquito season starts.

We could always think of moving the collections around, because we know from experience that the northern part of the province will be touched much later in the summer than the southern part. But it's very difficult, if not impossible, to move blood drives around in a such a fast track to follow the surveillance data.

Basically, the future perspective would be to think about pathogen reduction, but that will not be done for the summer.

One other aspect that might be looked at is immunoglobulin prophylaxis. We know that in certain types of immunoglobulin, there might be the presence of antibodies against West Nile virus, and this needs to be explored.

[Translation]

West Nile virus may be a risk for the blood supply this summer, and Héma-Québec will definitely put every measure in place to protect Quebec patients who need blood.

Thank you very much, Madam Chair.

[English]

The Chair: Thank you, Dr. Décary.

We'll move now to the representatives of the Department of Health. Ms. Hill, I don't know if you're going to start or if you'd like to direct one of the others, but it's up to you.

Ms. Julia Hill (Acting Director General, Biologics and Genetic Therapies Directorate, Health Products and Food Branch, Department of Health): Thank you. I will indeed be presenting.

[Translation]

I'm pleased to see you again so soon, ladies and gentlemen.

[English]

My presentation will mostly be in English, but of course I welcome questions in French.

I would just like to introduce the two colleagues I have brought with me: Dr. Howard Njoo, who is a physician from our Population and Public Health Branch; and Dr. Peter Ganz, whose background is in research and regulation particularly related to blood. Should there be any specific questions, I will defer to my two scientific colleagues.

I have a presentation, which has been shared with you. It is in three pieces: one is to just look quickly at the overview of Health Canada's blood safety program; then I have a couple of words on the profile of West Nile virus itself; and then a discussion of the strategies to reduce risk to the blood system.

Canada's blood system is a shared responsibility with the provinces and the territories as well as with operators and to some degree with citizens upon whom we rely to donate blood. The federal role clearly requires an element of leadership from the federal government and overall coordination, as well as regulation under the Food and Drug Act. In the case of the blood operators, we license and inspect their establishments. We also license products that may be used. That would include things such as Factor VIII for hemophilia, but also a variety of other plasma-derived products. We also have a responsibility for national disease surveillance, and this happens primarily through our Population and Public Health Branch.

The provinces are responsible for funding the blood operators, for regulating health professionals involved in blood operations, for medical practice, and for their own public health systems, which are then linked together through the federal initiatives. The operators are responsible for collection, management, and distribution of the blood supply, and among the other players, as I mentioned, certainly the donors are key. There are a number also of non-governmental associations, which would include organizations such as the Canadian Hemophilia Society, the Anemia Institute, and others.

We also have external advisory bodies. In Health Canada particularly we have the Expert Advisory Committee on Blood Regulation, which is chaired by the dean of medicine at Dalhousie University, Dr. Noni MacDonald, and consists of a number of members from across the country with expertise in blood. That is an independent arm's-length committee that provides us with advice. They have been very involved in the work we've being doing on West Nile virus.

The virus itself is a mosquito-borne virus with a natural reservoir in different species of birds. Most people infected with West Nile virus do not develop any symptoms. Most of us will not even know we had it. Less than one percent develop serious health effects. But that's significant, none the less, because it could be encephalitis or meningitis. There is at this time no specific treatment or vaccination, and most infected individuals not only don't know they had it, but recover. West Nile virus infection has a very brief period within which the virus is actually present in the blood, and that's prior to the onset of the symptoms. The incubation is one to six days, and it's all over and done with in three to six days—if we even know we had it. It's a sneak-attack virus, and that's one of the challenges in dealing with it.

I have provided you with another slide that gives you an indication of the spread of West Nile virus from 1999 to 2002. An important lesson to draw from it, of course, is what we know about where it was endemic last year does not necessarily mean it won't be found elsewhere next year.

º (1600)

[Translation]

Do you want me to wait? Is it the interpretation that isn't working?

Mr. Réal Ménard (Hochelaga—Maisonneuve, BQ): I said I didn't have the document, but, please, you can continue.

[English]

Ms. Julia Hill: The next slide provides you with test results as of January 29, 2003. Dr. Sher and Dr. Décary both referred to a number of cases in the provinces. We have not listed in there the number of suspected cases, which were somewhat higher. But again, it gives you an idea of the actual number we were dealing with in terms of confirmed deaths by the end of January. We recognize that every death is a human being who has a family and who has friends; we're very conscious that this is a human element, not just a statistic.

For West Nile virus and the path to human infection, as you will see on the next slide, there are a variety of ways, although the most frequent of course is the mosquito bite. That remains the most common path to human infection.

I'll just draw your attention to one bullet there that may look confusing. I had to negotiate this very carefully with my learned colleagues. I would have included infection in the womb with infection via childbirth, but it was explained to me that it's not quite the same thing. It's not what a child may pick up on the way through the birth canal but in fact what may be transmitted through the placenta. That's infection in the womb.

The breast milk is a possibility. There are no proven cases to date, but it certainly is a possibility.

As to general measures for managing West Nile virus infection--and this is just to remind us that it does of course go beyond the blood supply--remember again that mosquito bites are the most common path for infection. It does require cooperative action by all parties in the country, everybody in the partnership on blood. It includes a lot of collaboration between provinces, territories, the federal government, blood operators, and hospitals in terms of surveillance.

It does include a large education component, and I refer in this instance also to physicians and the need to assist them in recognizing what may be West Nile virus when a patient does come into the clinic so it is indeed reported as suspected. I also refer to education for all of us about some very simple measures, such as not going outside and exposing ourselves to mosquitoes at certain times of the day, dusk and dawn, which make us more vulnerable; and ensuring that we clean out things like bird baths so we're not developing reservoirs for mosquitoes, who may then breed, exacerbating the problem.

There are also discussions with the provinces, with environmental groups, etc., about the advantages and disadvantages at this time of things such as spraying programs to control mosquitoes. Of course, the primary focus of the discussion today and of our role in Health Canada is related to risk reduction in the blood system.

The next slide does give you a little bit more information, again statistically, about possible cases and confirmed cases. I will flip over that, because I believe it has been covered by my colleagues from Héma-Québec and CBS, and I will turn then to questions with respect to Health Canada's actions to date on this file.

In the early summer of 2002 we set up a specific task team. There has of course been surveillance ongoing for a number of years as we have been aware of West Nile virus moving through birds. It did take everybody by surprise to see, nonetheless, some of the developments this summer.

As we saw developments in the U.S.--and that is really our primary counterpart, because that is the one other country where they are dealing with West Nile virus as we know it here--we set up our test team. We initiated consultations with our expert advisory committee--to which I referred earlier and which is our independent, arm's-length committee--and we had discussions with our colleagues in the United States in the Food and Drug Administration who are dealing with this issue as well. We have had ongoing discussions with the blood operators as well as through the surveillance system in the provinces and territories.

So there's been a lot of exchanging of information and expertise on this, of people coming up with lessons learned, and of advice from elsewhere. We have attended special sessions, particularly one in November, that have been hosted by our colleagues in the U.S., and Health Canada itself ran a three-day consultative workshop in early January of 2003. The first two days of that workshop were primarily on working with surveillance systems in the provinces and territories, and we brought in all the chief medical officers of health.

º (1605)

The third day we invited a number of stakeholders, including the Anemia Institute, the Canadian Hemophilia Society, manufacturers who provided us with information on the status of their work with respect to test kits, the blood operators, and others. At that workshop we discussed the strategies we were putting forward and had developed and ones the blood operators had also identified, and we sought advice to see whether any of the other stakeholders would have additional suggestions to make.

The agreed-upon options to reduce transfusion risk you will find on the next slide in plan A, plan B, and plan C. Please note that we have called these three different plans, but in fact, as you will have seen from Dr. Décary and Dr. Sher's presentation, much of this is going on in tandem. We are all conscious that we don't want to put all our eggs in one basket, so to speak, and we need backup plans.

The preferred response to this would indeed be to have appropriate donor testing or testing of blood in any case, a method to ensure that the blood never enters the system and that we're able to identify people and blood that may have West Nile virus present. If there is not a test in place in time, plan B consists of targeting for high-risk patients, testing some donated blood through the diagnostic testing that is available now. This takes quite a long time to get a result, which is why it would not be possible for all blood, but there would be some testing and we would ensure that we targeted blood for high-risk patients.

Another part of that option, again, which was referred to by CBS and Héma-Québec, would be obtaining blood from low-risk areas to provide a West Nile-free supply. Dr. Décary pointed out that there are some practical impediments to that, and we would point out that the areas that are relatively risk-free at this time include, for example, northern Labrador and Newfoundland, parts of the country where the population density is not great. So the quantity of blood that could be collected, in addition to the ability of blood operators to move clinics rapidly across the country, in that way does present some practical challenges.

Another part of that option was augmenting collection in pre-mosquito season and stockpiling. Again, as indicated by CBS and Héma-Québec, that work has begun.

Plan C, which would be nice to get to at some point--and I put it as C because it is actually one of the least feasible at the moment--would be treating all donated blood to inactivate the virus. Dr. Décary referred to pathogen inactivation. At the moment there is one method that is licensed in Canada, but it is not immediately available to the blood operators because it would not appear to be compatible with existing systems, so there are some practical impediments there as well.

I'll just underline again the issue around the test kits. Most of these kits take from three to five years for industry to move from the research phase to an actual implementable test kit. So that is a challenge. We are hopeful with the information we have had from the manufacturers that they will indeed be in a position to submit a proposal to Health Canada by the very early spring. We anticipate being able to provide quite a rapid turnaround. We certainly will be making this one of our priorities. It is everybody's common objective to avoid any unnecessary risk to Canadians through the blood supply.

º (1610)

The Chair: Thank you very much.

If I can direct my members' attention.... They had a budget put in front of them, I believe. We're just going to take a minute now while we have a sufficient number of people present to have a vote. Would you just take a peek at this, folks? It's pretty well one page, and it's a sum of $24,000.

Mrs. Chamberlain.

Mrs. Brenda Chamberlain (Guelph—Wellington, Lib.): I'd like to move it.

(Motion agreed to)

The Chair: Thank you.

There are two others. This one is on Bill C-260 and is for $3,464. Mrs. Chamberlain's moving it, I believe.

Mrs. Brenda Chamberlain: Yes.

(Motion agreed to)

The Chair: Now, on the next page this one is about the HIV/Aids study, and it's for $8,000. Dr. Dromisky is moving approval of this one.

(Motion agreed to)

The Chair: Thank you very much to my members, and thank you, witnesses, for excusing us.

We'll now begin with the questioning. I think Ms. Skelton was the member who brought this whole concern forward, and Mr. Merrifield has suggested she be the lead questioner. Ms. Skelton.

Mrs. Carol Skelton (Saskatoon—Rosetown—Biggar, Canadian Alliance): Thank you very much, Madam Chair.

I'd like to thank our witnesses for coming today. I'm very grateful to have you here to answer some questions.

Who initiated the original testing? Did Health Canada originate the initial testing for West Nile virus here in Canada?

Ms. Julia Hill: I beg your pardon. Testing has not been initiated, but discussion around the requirement for testing.

Mrs. Carol Skelton: Is there not a lab in Winnipeg that is doing testing?

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Ms. Julia Hill: There are two types of testing we are referring to: there is a diagnostic test, or the confirmatory tests that are conducted on suspected cases. The samples are sent from the provinces to the Winnipeg lab for confirmation.

Mrs. Carol Skelton: So it's a diagnostic test, then.

Ms. Julia Hill: Yes.

Mrs. Carol Skelton: Thank you.

Have you looked at expanding that lab? How many technicians are working in that lab?

Ms. Julia Hill: Do you mean expanding for the purpose of dealing with West Nile virus?

Mrs. Carol Skelton: For testing, yes, for diagnosis.

Ms. Julia Hill: In the discussion that has been held internally--and I will refer in one moment to Dr. Njoo--the question in our minds is not whether West Nile virus can be transmitted through blood; we know it can. Our focus therefore is on prevention.

Mrs. Carol Skelton: You said you felt that very early this spring you will have a test for West Nile virus?

Ms. Julia Hill: We are encouraged that the manufacturers will be providing a submission, and that is the information we have from the manufacturers. That clearly is within their control. We have a maximum 30-day turnaround to assess the scientific information. We need to consider also, then, how well those tests fit with the blood operator systems, and the blood operators themselves will be providing us with information on that.

Mrs. Carol Skelton: It looks like serious time complications are going to set in here. Have you decided or have you any estimates on how much this is going to cost Health Canada or the Canadian Blood Services in Quebec?

Ms. Julia Hill: I would defer the question, if I may, to Héma-Québec and CBS. The role of Health Canada is to ensure that we facilitate to ensure that there is safe and effective blood. The funding to CBS and Héma-Québec falls within the purview of the provinces and territories.

Dr. Graham Sher: Thank you, Madam Chair and Ms. Skelton.

We do not have an accurate estimate of the costs now. We are beginning to get information from the vendor that we've decided to go with on what they would be charging per test.

There are many other costs to be incurred. In my slide deck I talked about renovating labs, buying new equipment, training our staff, accounting for transportation of samples. We're doing all their cost assessments now, and I can tell the members of the committee that this will be a very expensive implementation.

Concerning the provinces and territories that fund CBS, we have made them aware of the issue. We're in constant communication with our funding provinces and territories. CBS does have the capacity to spend money without awaiting approval from the provinces and territories. We have a contingency fund that we can draw upon immediately, but we are in active dialogue with our funding members and the provinces and territories around incurring the costs of this. But it will not come cheaply.

Mrs. Carol Skelton: I understand that your database and everything will have to be changed, according to what my knowledge is, that there are columns where you tick off the tests, and when the tests are completed, the databasing and everything will have to be changed.

Dr. Graham Sher: That is correct. This is not simply a matter of instituting a test in a laboratory; you have to manage the data in your databases, and that's part of the complexity of the timelines and the various submissions we will have to make to the regulator.

Mrs. Carol Skelton: Dr. Sher, what kinds of timelines are there? You're looking at early spring. In the worst-case scenario, is there a possibility that we won't have a test this spring?

Dr. Graham Sher: If the test is not ready by the manufacturers and not approved by the regulator, then yes, there won't be one in time. But if there is a test available in time, CBS has made every commitment to have that test implemented for donor screening at the very earliest opportunity.

Certainly, like our colleagues in the United States and even in Quebec, we are targeting the beginning of July. If humanly possible to do it sooner, we obviously would.

But the point I think we were trying to make is the necessity to develop contingency plans in the event the test is late in coming. We don't want to be developing contingency plans at the eleventh hour. We really need to have those plans in place now.

Mrs. Carol Skelton: What does occupational exposure mean?

Ms. Julia Hill: It really means people with cuts or abrasions or something of that ilk who are picking up the dead birds from the highway.

Mrs. Carol Skelton: That's people who pick up the dead birds from garbage cans.

What is the percentage risk that a test won't be available? What are you looking at?

º (1620)

Ms. Julia Hill: It's difficult to answer that as a percentage risk. The manufacturers are advising us and affirming that they will indeed have a test ready for submission sometime in the early spring. We can only take their word on it.

As we did mention, we are conscious that in most instances it takes from three to five years to get from research to a test. They have certainly done their best, to our knowledge, to accelerate that process. They said so publicly at the West Nile virus workshop we had in early January in the presence of members of the public. This is a commitment from the manufacturers.

As Dr. Sher said, however, we are all conscious of the need to develop contingencies. That's why this was discussed in that public workshop, to ensure that we had not left any stone unturned.

Mrs. Carol Skelton: Have you issued any new policies to the two blood agencies?

Ms. Julia Hill: Around September 30 we did issue a directive to the blood operators confirming instructions we had provided verbally through ongoing discussions with respect to the measures that needed to be taken. I will note that the blood operators had most of these measures in place, in any case. Dr. Décary referred to things such as deferring donors. This was one of the elements.

One of the discussions we had early on referred also to whether there was a possibility of inserting an additional question into the donor-screening questionnaire. But, as mentioned in the presentations, it's very difficult to nail down exactly what this question might be, given that most people don't ever know they've had it. It almost got to the point of asking “Have you ever been bitten by a mosquito?”, which is an odd thing to ask a Canadian.

Mrs. Carol Skelton: Are there any shortages of products right now?

Dr. Francine Décary: Well, of course we are not in a mosquito season, so there's no problem with the blood supply at this time.

Mrs. Carol Skelton: In Quebec. What about the rest of the country?

Dr. Graham Sher: It's the same at CBS. We've had an adequate inventory throughout, and we've managed the withdrawal with an adequate inventory. We're certainly looking to stockpile over the winter months in advance of the summer.

Mrs. Carol Skelton: Are there no whole blood shortages anywhere in the country right now?

Dr. Graham Sher: No.

The Chair: Thank you, Ms. Skelton.

Mr. Ménard will be followed by Dr. Dromisky.

[Translation]

Mr. Réal Ménard: Thank you.

In the presentation Ms. Hill made, are the modes of transmission in order of importance? Based on the reported, known cases, do you have a greater chance of catching the virus through blood transfusion, then by organ transplant, then by insect bite? No. All right.

Ms. Julia Hill: That's a very good question, thank you. We should have seen to that. Obviously, mosquitos...

Mr. Réal Ménard: ...are the primary cause.

Ms. Julia Hill: That's correct, absolutely.

Mr. Réal Ménard: That's what I had understood, but I thought that...

I understand that there is a detection test. A decision is drawn between the detection test and the second test which might exist. Are you confident that you can have that by the spring? It's Roche that is trying to market the test, isn't it? Am I mistaken?

Mme Julia Hill: It's one of the companies which, at our workshop, presented...

Dr. Décary.

Dr. Francine Décary: Yes. That's the company we selected following a recent call to tender.

Mr. Réal Ménard: So that company has undertaken to put on the market by late spring...

Dr. Francine Décary: July 1.

Mr. Réal Ménard: So there's a strict liability to perform.

Dr. Francine Décary: Yes.

Mr. Réal Ménard: Do we know the unit price of this test?

Dr. Francine Décary: Yes. Unfortunately, I don't have the information with me. I'll have to call Montreal to get an idea, but it's expensive.

Mr. Réal Ménard: It's expensive. In any case, you know that this committee will examine the cost of the drugs and that we'll make some adjustments. But let's stay calm and go ahead on a case-by-case basis.

So with regard to available tests, for Hepatitis C or HIV, for example, there are detection tests that are virtually proven. I understand there is a small window as a result of which that's the reason why homosexuals or persons who have had a homosexual relationship since 1977 cannot give blood, but let's say that, for Hepatitis C and AIDS, there are virtually reliable tests as a result of which the blood banks in Canada and Quebec are safe. There is a special system for Quebec.

One of you--I believe it was Ms. Hill--said that there is a pathogenic procedure, but that the method has not been approved. With regard to the test for which you issued a call to tender... Yesterday, I asked an excellent question in the House on the approval process, which is said to take 377 days, whereas, in 1995, Health Canada undertook to reduce the length of the approval process by half. Eight years later, we have time periods that are not at all competitive.

Isn't your optimism somewhat unrealistic, and isn't this a situation that will backfire on Health Canada, since its approval process is so uncompetitive that this will prove once and for all that all that has to be examined?

º (1625)

Ms. Julia Hill: These figures affect the products, but not the approval of blood institutions. We have much shorter time frames and we comply with our timetables.

Mr. Réal Ménard: So the registration process for Saquinavir, for example, is separate from that for this test.

Ms. Julia Hill: Yes.

Mr. Réal Ménard: Your optimism is justified, and we can't alter your thinking on that.

Ms. Julia Hill: You might be able to alter my thinking, but I'm not concerned.

Mr. Réal Ménard: Good. Your statement is that there is a pathogenic procedure, but that the approved method is not available in Canada. Explain that to me.

Ms. Julia Hill: It's simply that we don't know whether that's consistent with the systems already in place in Héma-Québec and the Canadian Blood Services.

Perhaps you prefer to respond as well.

Dr. Francine Décary: I'm not sure I understand the nature of your question, but we're already working with Roche on the nucleic acid tests for the AIDS and Hepatitis C viruses. So we already have a system in place that makes it possible to transmit test results easily to our production system. For this test in particular, they use the same mode of transmission. So with regard to the computer portion of this test, that won't be the hardest part.

Mr. Réal Ménard: I have a final question. In an ideal situation, of the three scenarios you have described, plans A, B and C, I imagine that the ideal situation would be plan A: preliminary screening. But if the test becomes available, we could tend toward that scenario. If you had to draw a comparison between the existing detection mechanism for Hepatitis C and for AIDS... Can they be compared? In the figures you gave, you say there are approximately 300 and a few probable cases and 11 cases of death, if I remember correctly.

Ms. Julia Hill: That's in the United States.

Mr. Réal Ménard: That's in the United States.

Ms. Julia Hill: Here in Canada, it's as of January 29.

Mr. Réal Ménard: All right. With regard to the extent of the epidemic, can we work in terms of a comparison for epidemics we already know about?

Ms. Julia Hill: I want to make sure I understand the question you're asking. I should tell you in passing that we don't think of this virus as an epidemic, but there is nevertheless a risk. So are you asking me what method would be the preferred method? Would it be screening?

Mr. Réal Ménard: We're talking about a sample of 300 and some cases which are probably infection cases, but, in fact, 11 deaths have been observed. Preparations are being made to set up a detection infrastructure that will obviously be conditional on a test's availability. Is this a comparison which could have been done with what has happened for AIDS or with Hepatitis C? Because the purpose of the test is to protect the integrity of the blood banks. Obviously, the day a test is available, that will of course result in significant costs.

I was told that a Hepatitis C detection test would cost roughly $60 per unit.

Dr. Francine Décary: No, that's too expensive. Perhaps I'll try to answer your question. Based on the results obtained by the Health Canada people, an estimate was made of the risk of finding donors who are positive for West Nile virus this summer, and it was estimated that one donor in 5,000 would be positive for West Nile virus. So if we consider that we might have 100,000 donors in Quebec this summer, that would mean we would detect roughly 20 persons, which is much higher than what we detect for Hepatitis C virus. So if the test is there, it will really be a test that will ensure the supply is very safe.

º (1630)

Mr. Réal Ménard: That's what I meant by my question.

Ms. Julia Hill: I could also ask Dr. Njoo to respond further, if you wish. I'm sorry, I sort of missed the boat.

Mr. Réal Ménard: I nevertheless found your comments highly credible; don't worry about that.

[English]

Dr. Howard Njoo (Director General, Centre for Infectious Disease Prevention and Control, Population and Public Health Branch, Department of Health): I'm not sure I can add more to what Dr. Décary has already said.

In terms of determining the risk of West Nile virus--in terms of testing for it in blood--at this point, we're still collecting the scientific data. The problem is that a large number of potential donors would be asymptomatic. It's about one percent or so who would actually have symptoms, see a physician, and get tested for a diagnosis. Therefore, we just don't know the figure right now that represents the true prevalence of the West Nile virus in the general population.

There are some early prevalence studies being conducted, and in certain areas they're thinking it might even be as high as 20% to 30%, but at this point we just don't know. So even though we have a certain number of reported cases, the true prevalence of West Nile virus in the general population could be much higher than what's actually reported to us at this point.

The Chair: Thank you, Mr. Ménard.

Dr. Dromisky.

Mr. Stan Dromisky (Thunder Bay—Atikokan, Lib.): Thank you, Madam Chairperson. I would like to follow through with questions in the same direction in which we're heading right now.

We know mosquitoes love warm-blooded animals as their source of food, and we're really concerned here about birds. We have in the animal kingdom a great number of warm-blooded creatures. Is anyone doing any research that doesn't just look for dead birds? Has anyone been exploring other avenues? Is there any kind of transmission into other species? What about cattle? What about swine? What about dogs and cats and other creatures that get bitten by mosquitoes?

Dr. Howard Njoo: I'll answer first.

In terms of ecological surveillance in animals, I think probably the most easily used species is birds in terms of finding and testing them.

It has also been found in horses through testing. In terms of the practical aspects of testing other warm-blooded animals, like cats and dogs, I'm not aware this is being done.

Dr. Peter Ganz (Director, Biologics and Radiopharmaceutical Evaluation Centre, Biologics and Genetic Therapies Directorate, Health Products and Food Branch, Department of Health): I'm not aware of any studies on any other animals, but as Dr. Njoo indicated, I think there is tracking for equine species, horses that have been infected, and there are a number of deaths in horses due to West Nile virus.

Ms. Julia Hill: If I may just add to that, one of the reasons birds are also good indications in terms of tracking the progress across the country is that they travel farther, as well.

Mr. Stan Dromisky: I would like to continue by trying to get some clarification regarding an awesome project listed with the Canadian Blood Services--the implementation of a new donor screening test by July 1. You have put in some conditions there. It will be a challenging task for all parties.

For instance, you mentioned that the necessary regulatory approvals will need to be completed. Who is going to create these, and by whom are they going to be approved? How long is this process normally, in your experience? Are we talking about a week, ten months, five years? Does it have to go through all kinds of government channels? What happens in this situation?

You mention the design, renovation, and commissioning of laboratories--all by July 1. I can't believe it. I don't know what that truly means. You might have all of these infrastructures in place already and not have to spend any money doing the kinds of things this statement implies. I'm not too sure.

You referred to the installation and validation of equipment. Does new equipment have to be created, glass blowers, other kinds of electronic devices and so on? I don't know.

This seems to me like a task that can never be achieved by July 1. I don't know how this can all be done.

Dr. Graham Sher: Dr. Dromisky, it is indeed a huge task.

To your first question, who gives the regulatory approvals, we are regulated and licensed by Health Canada. As Ms. Hill said, they will need to approve the necessary steps to have the manufacturer's test approved. Once those steps are in place, our licence to operate and to use this test would need to go through the necessary amendments. Health Canada has certainly committed to doing this in the most expeditious manner possible, and I'm sure it will.

With respect to renovating existing laboratories, we have to do it. Our existing laboratories are not amenable to the equipment required for West Nile virus testing. This will be--and certainly Dr. Vamvakas can provide more details--equipment we currently do not have for the existing testing regiments. We have to require new tests, new pieces of equipment, train our staff on them, make sure the labs are suitable to hold this equipment, and do all it all in the next few months.

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Mr. Stan Dromisky: Does that mean new equipment has to be created for the kinds of tests you have in mind, or do you simply go to a wholesaler who has equipment already in the store and purchase what you need?

Dr. Stephen Vamvakas (Executive Vice-President, Medical, Scientific and Research Affairs, Canadian Blood Services): We have already started renovating the laboratories. The equipment hopefully will be delivered to us from Europe by mid-May. In this part of the contract with Roche, we are setting this condition, that we need the equipment in time. There are risks at every step of the way, but these risks are being managed.

Mr. Stan Dromisky: The reason I'm asking that question is because if this kind of information is given to the public, you're raising expectations among the public, which in my mind can never be achieved by July 1. I'm glad you're giving some clarification here. We're going to have to wait to see what happens by July 1.

Thank you very much.

Ms. Julia Hill: That was one of the reasons why we held the public workshop in January. There was a strong public representation there, particularly of non-governmental organizations who have the network throughout the country, to discuss and ensure that everybody understood. What we have not said there and are not saying here is that there is any guarantee. That is precisely why there are different plans and different contingencies happening at the same time.

In our case, we need to know that the blood operators have their contingency plans. That's part of our regulatory role as well: ensuring that we ourselves are fully aware of what is happening in industry. We are lining people up now to be on those submissions as soon as they come in. We are conscious of the risks, all of us. Our objective is to get there for July 1, but we have back-up plans.

Mr. Stan Dromisky: All the factors in the equation are there except for one I haven't mentioned yet, and it is a very important one. That's money.

Dr. Graham Sher: As I indicated in response to Ms. Skelton's question, Madam Chair, certainly the provinces and territories who fund CBS have been made aware of the urgency of West Nile virus. We have the capacity to spend money currently, but certainly the provinces and territories will need to incur the ongoing operating costs of this, and we are and will be in close dialogue with our funding provinces to make sure this issue is dealt with.

The Chair: We will have Mr. Merrifield, followed by Dr. Bennett, followed by Dr. Lunney.

Mr. Rob Merrifield (Yellowhead, Canadian Alliance): Thank you.

The questions I have, and I guess the alarm most Canadians feel, is that this was supposed to be contained in the United States, with a few casual risks in Ontario last year; yet when the year was over, when we picked ourselves out of the dust, we realized that 11 people had died in Canada, and that there were many more cases here than ever we thought. The United States was just as fooled, with thousands of cases.

You came to us today saying there were 11 deaths, 144 confirmed cases. I would like to know how many cases.... You alluded to cases where you suspect this disease to have been contracted. Do we have a handle on that? I think that's the uneasiness we feel and Canadians feel, that we've been fooled once. Are we going to be fooled again this summer, and is this thing larger than we expected?

Ms. Julia Hill: I'll ask Dr. Njoo to respond to this, but I would also comment.

One of the issues we talked about in the public workshop and addressed is the need for sensitizing physicians and citizens so that it is reported—but again, noting that very few of us actually exhibit any symptoms. That's why it's such a sneaky pathogen.

Mr. Rob Merrifield: That doesn't mean we don't have it, or can't be a carrier.

Ms. Julia Hill: No. Precisely.

Mr. Rob Merrifield: Do we have a handle on that side of it? Probably not.

Ms. Julia Hill: No.

I'll ask Dr. Njoo.

Dr. Howard Njoo: To answer that last point, that's why we're in the process of doing various types of population studies to determine what is the prevalence of West Nile virus infection in the general population, especially among those who are asymptomatic.

With respect to your first question, I think it's important to understand how the surveillance system works in Canada. At the national level, surveillance for infectious diseases really depends on the provincial surveillance systems and a working agreement between Health Canada and the provinces. What underpins the provincial surveillance systems in terms of accuracy, validity, really getting all the cases counted, is legislation.

At this point, we have a list of what we call “notifiable diseases”—it's about 40 or so—in which the provinces have agreed to report all those cases to Health Canada. Those include diseases such as tuberculosis, encephalitis, and so on. West Nile virus is not on the list yet, and the reason is that in each province they're just dealing with it for the first time. The first human case was reported in August of 2002, so the provinces in a sense are scrambling.

At the present time, as Ms. Hill suggested, it's also a process of sensitizing the physicians, because there is no legal framework right now. It's basically a matter of public health officials sensitizing physicians to try to order the appropriate tests for any patient they see in their practice who might have West Nile virus infection.

What happens, then, is that by having laboratories and physicians test for the infection in their patients, we've developed an interim system in which the public health authorities, as soon as they become aware of positive test results, will report both to Health Canada and to the blood operators so that we can take the appropriate public health actions.

º (1640)

Mr. Rob Merrifield: Yes. So if I interpret that properly, the map here shows that West Nile goes as far as Saskatchewan, but in reality it could have gone right across the country but not have been recorded this last year.

Dr. Howard Njoo: I think it's an accurate representation in terms of dead birds.

Mr. Rob Merrifield: That's fair enough?

Dr. Howard Njoo: It's for dead birds, not for humans.

Mr. Rob Merrifield: Okay, let's get on to the dead bird and the mosquito as being the carrier. I'm just trying to get an understanding of it, and it may be more a scientific question, but you say it's carried by the mosquito, obviously through the blood. As the mosquito stings the individual, that's how it penetrates the human or the horse, or whatever.

We have flies that are blood drinkers, you might say, as well. Is it just the mosquito, or is it carried by other insects? Could it be by blackflies and an open wound?

Dr. Howard Njoo: It's principally the mosquito, because the mosquito has to, in a sense, bite and draw blood from an infected bird that has the West Nile virus, and then, in turn, bite and inject the infected blood into a human, and flies don't do that.

Mr. Rob Merrifield: My understanding was that mosquitoes only bit once too, but maybe not. It's not that I'm challenging you; I'm just wondering if we're not getting a handle on it because it could be carried by other means and other insects.

Ms. Julia Hill: So you're thinking of a horsefly, for example, which draws blood.

Mr. Rob Merrifield: A horsefly is an example. The little no-see-ums, or whatever they're called, they're all blood-drawing insects.

Dr. Peter Ganz: All I can add is I don't believe there is any scientific data, and West Nile virus has been around for a very long time. By its name, it was identified first in the Nile region in Africa, and we know a little bit about its pathophysiology and the way it works and the way it's transmitted. To my knowledge, I don't believe there's any scientific information that says it could be transmitted by flies. It is restricted to mosquitoes.

Ms. Julia Hill: In fact, just to add to that, an interesting learning that I had is that it's not all kinds of mosquitoes. There are types of mosquitoes in Newfoundland that don't pick it up or transmit it, so it's--

Mr. Rob Merrifield: I'm not going to touch that one.

Ms. Julia Hill: I'm also hearing one underlying.... I'm not sure we're all absolutely clear that not only do we not know that we have had it, but when it's gone, it's gone. It's not something that.... If I've had West Nile virus, I can go back and donate blood a month later and I'd be clean--two months later, I beg your pardon, yes. So it's not like malaria, which comes back.

Mr. Rob Merrifield: Yes. That's fair enough.

My concern is on the cost side of this test, and I'm glad to see Health Canada is accelerating the process as much as possible. I think that's important. Actually, it's really refreshing to see that it can be done, and hopefully it will be by July 1. But when you look at testing this, every individual who donates blood will be tested from here on. Is that how you're going to have to do it, and if that's the case this year, it's the case forever?

Dr. Stephen Vamvakas: Well, it is conceivable that we could stop a few years later, if there was no epidemic for two or three years in a row. This has not been decided yet.

In answer to your previous question, I would like to mention that half a million Americans in the U.S. contracted West Nile, this virus, last summer. That is the CDC estimate. Also, the CDC estimated that the risk from transfusion is one per 30,000 donations. So one per 30,000 units collected carries the virus. This is not a small risk.

º (1645)

Mr. Rob Merrifield: It's not a small risk. Is that what you're saying?

Dr. Stephen Vamvakas: Exactly. It's a huge risk compared to the other viral risks of transfusion.

Mr. Rob Merrifield: That's why I'm just sort of laying it out, trying to get a handle on it.

The suggestion is that this virus is here in North America and will be for some time to come, for the foreseeable future. Once we get a test, then everyone who donates blood will likely have to be tested. Is that the way you see it, in the foreseeable future?

Dr. Graham Sher: Yes.

Mr. Rob Merrifield: So when we get down to the costs, coming back to the cost of it, you haven't given us a handle on the costs, but I think it's important, because, as you said, Dr. Sher, it is going to be a significant cost.

Dr. Graham Sher: It certainly is, Mr. Merrifield, and I think the point we're trying to make, as Dr. Vamvakas said, is that the actions you see being taken by the operators and the regulators here are, in our view, commensurate with the risk.

This is a high risk for blood products. This is much higher than the current risks for hepatitis C or HIV through blood transfusions. So these sorts of actions are, in our view, absolutely commensurate with the magnitude of the potential risk.

Mr. Rob Merrifield: Thank you.

The Chair: Thank you, Mr. Merrifield.

Dr. Bennett.

Ms. Carolyn Bennett (St. Paul's, Lib.): I have two parts to my question, and the first is just around prevalence. When we talk about the number of West Nile infections or whatever, in the description you said most people are asymptomatic, some get pretty sick, and some die. Could somebody just put it in the context of the flu in terms of prevalence as to how many people get sick and how many die? That is, how many people would die of flu in Canada a year and how many would die of West Nile?

Dr. Howard Njoo: I'll take a stab at that.

If I were to compare, from a public health point of view, the actual burden of illness, morbidity, and mortality of influenza compared to West Nile virus, I would say flu is much higher.

Ms. Carolyn Bennett: Isn't it hundreds or thousands of times higher?

Dr. Howard Njoo: It's severalfold higher, that's for sure.

I think that part of the issue is that for influenza there is something we can do about it in terms of people getting the flu vaccine every year, but in terms of actual numbers of people who partake of the vaccine, the actual uptake is quite low; therefore, there's still quite a high morbidity-mortality rate associated with influenza every year in people such as the elderly and the immunocompromised. I don't have the exact numbers, but I can always get that for you in terms of the actual number of deaths compared to--

Ms. Carolyn Bennett: I'd like it, because we still have to put this in the perspective of things we can do something about and things we can't do something about. I don't know what it is, but I would say that thousands of people die of the flu every year, yet we're sort of looking at this little thing. Now, I don't know how that affects the blood system.

Maybe Dr. Sher wanted to respond.

Dr. Graham Sher: If I may, Dr. Bennett, I think your point is a very good one. From the broadest public health perspective, one has to look at motor vehicle accidents, cigarette smoking, flu, and all sorts of things. From the perspective of protecting the blood supply, this is clearly the risk of the moment and this is the one we clearly need to respond to. I think that's the distinction here.

Ms. Carolyn Bennett: My second question is around sensitizing physicians and all that. It's been a bit of a pet peeve of mine that when we recall a drug or when we have something new, we get a letter from Health Canada three weeks later. When we had the threat of anthrax or we had a lot of those things, there was a certain cobbled-together approach with the CMA to talk to doctors. Shouldn't we expect in this country for there to be a better way than sending an e-mail out to every physician in the country to tell them about West Nile or to remind them of the symptoms? Isn't there a huge gap? CDC has big satellite broadcasts any medical lounge in the country can bring in. Why are we so slow in talking to doctors in this country?

Dr. Howard Njoo: In answer to part of your question, I think we actually do quite well in Canada. We use the same modalities as the CDC in terms of teleconferences and so on. You're right, we still use some of the traditional methods, be they faxes or e-mails. In large part that's done through the provincial governments, because they are obviously, as you know, responsible for health, so it's organizations such as the Ontario Medical Association that would fax or e-mail based on their membership list.

Health Canada's role would in a sense be coordination in terms of working with the provinces and territories to make sure that this same message is there in terms of what needs to be--

Ms. Carolyn Bennett: As a Canadian, wouldn't I want to think that Health Canada had the ability to talk to every physician in the country? My experience with anthrax was that it was done in groups such as emergency physicians or people they thought must...but I don't think it goes to the nursing station in Cambridge Bay. We should have a better way of making sure that doctors aren't intermediated by a whole bunch of people who think they know who should or should not get it.

º (1650)

Ms. Julia Hill: Dr. Bennett, there are always ways to do things better, so I think that's a very valid comment.

In this instance, over the three days at this workshop, the notion was that by our bringing all these people together with the chief medical officers of health of every province, who have a system in place and who have a responsibility for the physicians within their provinces, they will then role out. That's not to say Health Canada doesn't have a role there somewhere as well. We do have to be careful, however, that we focus our resources and our time on the areas that are clearly within our responsibility, and we expect other partners to play their role as well.

I suspect what we need to do is to have more discussion with these groups who have the multiplier effect about how together we can ensure that information gets out there more effectively. That's certainly something we can undertake to do.

Ms. Carolyn Bennett: But you think that it has to be done group-to-group and that Health Canada shouldn't be able to just send out an e-mail to every doctor in the country and say did you know that such and such is now around?

Ms. Julia Hill: That may be one thing we could do. We do have to be careful, in the structure we have within our FPT arrangements, that we're respectful of the practice of medicine, a jurisdiction that is clearly within the provinces' competence. But it doesn't mean we can't share information.

Ms. Carolyn Bennett: Do you do drug recalls and that kind of stuff now?

Ms. Julia Hill: Yes.

Ms. Carolyn Bennett: It's because that's directly yours.

Ms. Julia Hill: That's immediately within our purview, correct. There is also a relationship in that when we have a recall we ensure that the lookback-traceback reaches out to physicians everywhere so they in turn can speak to patients.

Ms. Carolyn Bennett: If you see an outbreak of Lyme disease, legionnaires' disease, or anything, don't you have a way of talking to doctors, saying, “Have you thought of this recently?”

Dr. Howard Njoo: No. At the national level, once we detect an outbreak of a certain disease, we go through our network with the chief medical officers of health in the public health system.

The Chair: Thank you, Dr. Bennett.

Dr. Lunney.

Mr. James Lunney (Nanaimo—Alberni, Canadian Alliance): Thank you.

I'd just like to come back to the deaths. How many of the tenprobable deaths were related to organ transplants?

Dr. Graham Sher: There were none in Canada, to my knowledge.

Ms. Julia Hill: There were none in Canada.

Mr. James Lunney: There certainly were in the States, quite a high number, is that not right?

Ms. Julia Hill: We know it is feasible. We know there were cases in the summer that were suspect. There was confirmation in the U.S. I can again defer to my colleague, but the bottom line is we know it is transmissible through organs.

Mr. James Lunney: Again, you have immunocompromised people with transplants, and of course any virus can be a serious thing when you're immunocompromised.

But look, if we're coming back, do we have fewer than one in 155 according to some reports? Even though they've had any kind of infection, even though they've had a sniffle, fewer than one in 155. We have an infection that from start to finish, including incubation and the days when you might have three to four days of symptoms, takes 10 days; and then within 60 days, according to your testimony, you're able to give blood safely.

So when I hear discussion about wanting to test every donor and where you have 800,000 units collected annually, isn't the object here to protect the high-risk people rather than to try to protect everybody or screen every donation? Certainly, for the average person, if they've had a loss of blood or if they're in for surgery, as long as they have an immune system, the risk from an infection they may not even know they've had is certainly very low. Would it not make more sense to adopt what I believe you categorize as plan B rather than plan A, which would be to test everybody and screen every blood sample?

Who would like to respond, for starters?

Dr. Stephen Vamvakas: More than half the transfusion recipients would fall in the high-risk category because everybody over 65 is considered high risk for West Nile, and more than half the recipients are over 65. It would be very difficult to selectively direct low-risk units to high-risk people.

Mr. James Lunney: But not everybody over 65 is immunosuppressed, for example.

Dr. Stephen Vamvakas: They don't have to be. In the transfusion-transmitted cases in the U.S., four of them had only advanced age as the risk factor, with no kind of immunosuppression.

º (1655)

Mr. James Lunney: Can we talk about blood alternatives? Are there alternatives to blood, perhaps the artificial blood they've been working on?

Dr. Stephen Vamvakas: There are alternatives. They are not yet at the stage where they can be used in routine practice. We can use them on people such as Jehovah's Witnesses or in extraordinary cases, but they are not suitable for general use. The complications or the safety risks do not justify their use.

Mr. James Lunney: I've heard evidence that in fact for someone with just blood loss, a simple saline solution and hyperbaric oxygen can keep them alive. After all, we replace 25% of our red blood cells in 30 days anyway. Is that possible?

Dr. Stephen Vamvakas: It is possible only if the blood loss is limited. If you abruptly lose 40% of your blood supply, you go into shock. Unless you get a transfusion immediately, you will not survive this.

Mr. James Lunney: But you need blood volume to keep you alive, not necessarily blood itself.

Dr. Stephen Vamvakas: No, you need oxygen-carrying capacity plus blood volume.

Mr. James Lunney: But I've heard that even saline with no red blood cells can keep you alive if you have hyperbaric oxygen administered.

Dr. Stephen Vamvakas: If you're in very good shape and you do not lose a lot of blood.

Mr. James Lunney: You're not going anywhere in a hurry, but it would keep you alive while your own system replaced your blood. Is that something somebody is looking into?

Dr. Graham Sher: If I may add to what Dr. Vamvakas is saying, I think it's very important to appreciate that the vast majority of transfused blood goes into people who need exactly that, either the red cells, the plasma, or the platelets. And saline and hyperbaric oxygen and others would not be amenable to the vast majority.

Are there clinical situations where physicians should review their prescribing practice and minimize exposure to human blood? Absolutely, but they must form the tiniest minority of transfusions.

The vast majority of transfusions are clinically indicated and there are no licensed alternatives at this point in time. There are certainly agents in clinical development that may come down the pike in the next few years, but they're not yet part of our armamentarium.

Ms. Julia Hill: And if I may add to that, the decision in any case as to what product is provided to a patient is the decision of the physician, and the obligation of the blood system is to ensure that safe product is available.

There have been a couple of public fora discussing blood and blood substitutes, as well as blood conservation. And certainly the community--and again, I'm referring to the partnerships, so not just Health Canada--is aware of the need to address this issue.

Mr. James Lunney: From what we've heard here, you're looking for one in 30,000 units that might contain West Nile virus, or one in 40,000 if we understand Héma-Québec's estimate. That's considered very high, but it's one in 40,000. Isn't it important to make sure that the people in the highest need get clean product, rather than making sure that everybody does?

Dr. Stephen Vamvakas: I think it is important to make sure that everybody gets clean product, because more than half of the people are at risk of developing the disease, and it is completely unpredictable who will develop the disease.

Ms. Julia Hill: And the lessons from Justice Horace Krever showed us that those are not decisions that we ought to be making. Our responsibility is for the people of Canada who require blood.

The Chair: Thank you, Dr. Lunney.

Mrs. Chamberlain.

Mrs. Brenda Chamberlain: Thank you.

I spend a lot of time outside in the summer and with the bugs, and I find this kind of scary. I really do. Maybe people who are in the city or not out in the wilderness don't think of this. Do you find this scary, or no?

Ms. Julia Hill: Am I telling my kids to wear mosquito spray? Yes. We do have mosquitoes in the city, too.

Mrs. Brenda Chamberlain: Yes, I know.

Ms. Julia Hill: So for most of us, on a personal level, because West Nile virus is not something that bothers us at all--we don't know we had it, it's here again, gone again--it really is not an issue. It's more a concern of what we might unwittingly introduce into a blood system if we are blood donors. That's more of a concern.

Mrs. Brenda Chamberlain: How many people do you estimate have died because of the bite? Do you know that? And it's a guesstimate, obviously, because you don't know.

Dr. Howard Njoo: At this point we're still collecting the data, and the provinces are still in the midst of actually confirming their cases in terms of actually getting test results back, so the number changes daily. So we can't give you an exact number right now. Even the figures we've given you in this presentation, as of today I understand they're in a sense a bit out of date, because some of the numbers have been updated.

» (1700)

Ms. Julia Hill: But those eleven are people who are confirmed to have died from West Nile virus.

Mrs. Brenda Chamberlain: But this is through the blood transfusion? No?

Ms. Julia Hill: No.

Mrs. Brenda Chamberlain: This is through the bite of the mosquito. Is it?

Ms. Julia Hill: Yes.

Mrs. Brenda Chamberlain: I don't want to be bitten, Madam Chair.

Dr. Graham Sher: To be clear, Madam--

The Chair: We want you to be back here next September.

Mrs. Brenda Chamberlain: Exactly, and I'm planning for this.

Dr. Graham Sher: To be clear, Madam Chair, there is one case in Canada of confirmed death from West Nile virus as a consequence of a blood transfusion, the patient in Kitchener-Waterloo I referred to earlier. She is the only one of the people--

Mrs. Brenda Chamberlain: That's very close.

Dr. Graham Sher: You're in the epicentre.

Mrs. Brenda Chamberlain: But now the encephalitis, how many have died from encephalitis? Do we know that?

Dr. Howard Njoo: Of the eleven? I'm aware that a number of them have undergone autopsies and they actually have found the virus, I think, in the lining of the brain and so on. So it's a proportion. I can give you an exact number, but that might change tomorrow in terms of further confirmation. It's about half or so.

Mrs. Brenda Chamberlain: I think, Mr. Ganz, you said it's an old disease. How old?

Dr. Peter Ganz: Again, there were reports originally, obviously, in the Nile area. That's where the disease started. Presumably the question you're leading to, or an answer you're looking for, is why is there no epidemic there? Again, as someone indicated in their background material--I'm not sure whether it was CBS--you do develop immunity.

I think the population in North America is a naive population. We have not been exposed previously. Actually, maybe Dr. Vamvakas can elaborate on this a little bit, but it's believed that infected birds were imported from that region.

Clearly there is an opportunity for individuals who are infected to develop immunity, which does provide protection. Hence the appropriate question about whether or not in three or four years we need to test.

Mrs. Brenda Chamberlain: Are you suggesting that if I were out and I got bitten three times and I got it three times, whether it showed up or not, I could become immune? Could I?

Dr. Peter Ganz: Yes, you could.

Mrs. Brenda Chamberlain: I don't know why this is so humorous.

The Chair: You're asking questions a lot of people are thinking about.

Mrs. Brenda Chamberlain: Yes.

Do you know what? I want to tell you that I send out a lot of information on this to my constituents. While you say yes, it's out there and we have to be vigilant, I think people are really quite concerned about this. This is what I got from my constituents. Out of a lot of mail-outs that I do, this was one of the ones that had people picking up the phone, e-mailing, and saying “Am I ever glad you sent this, because I'm really concerned about this”. So I'm not a suck.

Dr. Peter Ganz: I have another comment to your question. As Dr. Décary indicated, there is work going on in terms of dealing with West Nile disease. There's an American company developing a vaccine. That's not going to be ready for at least a couple of years, maybe actually one year--there's a range.

As Dr. Décary indicated, there's also some evidence in the scientific and medical literature that a particular kind of blood product, which is called an immunoglobulin product, might contain some of the antibodies that would fight the West Nile virus infection. So there might be some opportunity for individuals who have a serious complication due to infection to be treated with this kind of product.

Mrs. Brenda Chamberlain: You said it was old, but you didn't tell me how old. Do you know how old?

Dr. Peter Ganz: In the 1920s.

Mrs. Brenda Chamberlain: Is that right?

Dr. Peter Ganz: Yes.

Mrs. Brenda Chamberlain: That's amazing. And we've now just been exposed to it?

Dr. Peter Ganz: Recently, since the epidemic started in the U.S. in the summer of 1999.

Mrs. Brenda Chamberlain: We don't know how many times we'd have to be bitten to be safe, do we? We don't know that.

Dr. Peter Ganz: No.

Mrs. Brenda Chamberlain: Did you want to...?

Ms. Julia Hill: Yes.

Something my public health colleagues have primed me on when we had this discussion, because I have spoken with a lot of citizens, a lot of people, is that there are factors in our control. That comes back to ensuring that we don't have stagnant water sitting in the barrel somewhere or in a bird bath, that we take what we know as natural precautions at dusk and at dawn, because those are really the times, basic things like having window screens in place, which many countries, including those of us who live in highly infested blackfly and mosquito areas, do anyway. But it's worth reminding, I suggest, constituents about these steps.

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Mrs. Brenda Chamberlain: Absolutely. I couldn't agree more.

Just on that, when we talk about the provinces looking at spraying, for instance in Ontario, are we working in conjunction with that program or not?

Dr. Howard Njoo: Within Health Canada there is the Pest Management Regulatory Agency, which provides advice in terms of the various products available in terms of insecticides and so on. Ultimately, it is a provincial and local decision in terms of what types of measures they would want to implement.

Mrs. Brenda Chamberlain: You would monitor what? The type of spray they'd use? Now there's some contention also around the fact of whether spraying is a very good thing. Is that going to kill you? Right?

Ms. Julia Hill: Yes.

If I may, the expertise that we have at the table really relates to the blood system.

What I can tell you is that within Health Canada there is to be, very shortly, a meeting.... There's been a lot of discussion of the various parts in Health Canada who are working with the provinces and who are working with different organizations in making sure we have a good plan in place to have an overall understanding of what's going on. There are some things that are within Environment Canada's mandate, for example, as well as being within that of the provinces and territories. So there's quite an effort to ensure there is a horizontal, integrated approach to all of this.

Mrs. Brenda Chamberlain: Was that a yes?

Ms. Julia Hill: It was a yes, it is being looked at. Very serious attention is being paid to make sure we're paying attention to all of the parts and that everybody is working together, not only up and down provinces and territories but also across various federal government departments.

Mrs. Brenda Chamberlain: My understanding is that Ontario is going to spray. Is that correct?

Ms. Julia Hill: I can't tell you. I wouldn't know that.

Mrs. Brenda Chamberlain: Do we put any money toward that federally, or do the provinces look after that?

Ms. Julia Hill: You have the wrong people at the table, but we can get that information for you.

Mrs. Brenda Chamberlain: Okay. Thanks. That was very informative for me.

The Chair: For all of us, Mrs. Chamberlain. Thank you for your questions.

Mrs. Brenda Chamberlain: I have one further question, Madam Chair, which is not related. It's just to let Ms. Hill know that we haven't forgotten about diabetes. We're getting you back in a month or so with some solutions for that.

Ms. Julia Hill: I hope you mean something other than “getting me back”.

Some hon. members: Oh, oh!

Mrs. Brenda Chamberlain: Having you here again as our guest.

Ms. Julia Hill: I can assure you that I haven't forgotten about diabetes either, and I will be delighted to be back.

Mrs. Brenda Chamberlain: Thank you so much.

I just wanted to give her a heads-up.

The Chair: We're going to be going steady with Ms. Hill pretty soon, I think.

To the Canadian Blood Services, the thing that's concerning me is that it says here “A commercial nucleic acid testing assay...is not available...”. You say that you are working with test manufacturers, but then you say that you have selected a vendor. Does the vendor have anything to sell yet, or is he or she still working on the development of the test? If there are various commercial enterprises out there trying to develop a test, why would one select a vendor before one knew the test was valid?

Dr. Stephen Vamvakas: We have to renovate laboratories, get new instruments, train our people to use those instruments, and so on. We have to do everything within three months. So we cannot wait for the development of the test before we choose a vendor and start working on the implementation of that test--

The Chair: But the whole point becomes moot if the scientific firm that's developing the test tells you on June 15 they're sorry, but despite their best efforts, they don't seem to have one.

Dr. Stephen Vamvakas: Hopefully, we would know before June 15 should that happen. But there is a distinct possibility of that happening.

The Chair: Are you helping to fund the development of this test? When you say you've selected a vendor, have you flowed any money to them yet?

Dr. Stephen Vamvakas: No. They have a market in the U.S. and here.

However, we're working in-house on the development of a test. So is Héma-Québec. Therefore, should something go wrong, we would have a test developed in-house to test a small number of donations for high-risk patients.

The Chair: My second question: Is there something very strange or extremely sensitive about the West Nile virus that requires the renovation of labs and some type of equipment that's totally different from those pieces of equipment you use to test for other viruses? What is it about this virus that's so special?

We're inclined to be a bit skeptical. We saw what happened on 9/11. Then the whole world was turned upside down, in some cases by people who already wanted to renovate their labs, to use a comparison, and now they had an excuse.

» (1710)

Dr. Stephen Vamvakas: “Renovate” is a very bad word. I apologize for the choice of words.

The problem with this virus is that the level of viremia is extremely low. With HIV or hepatitis C we have a 100-fold or 1,000-fold greater viral load in the circulation. Thus, the sensitivity of the test to pick up the infection when it is present in the donor does not have to be that high. But for the West Nile virus we are talking about an exceedingly low viral load, and we need a very sensitive test. In order to have such a sensitive test, we need new technology.

The Chair: Okay. I understand now.

We were talking here while Mrs. Chamberlain was asking her questions. I couldn't decide at the end of that whether I want my young people to get bitten and get the virus in order to develop immunity, or to tell them to wear all kinds of insect repellent and long pants and socks and maybe a hat all summer. What is it I want them to do, according to the best information you have? Let's take a young, healthy, 25-year-old.

Dr. Howard Njoo: I'm sorry, is the question what would we recommend?

The Chair: Am I trying to prevent healthy people, say, less than 60 years old, but not babies, because babies of course are sensitive to these things, but from 10-year-olds to 60-year-olds.... Do we want to allow them to get bitten and develop the immunity while they're young and healthy, so that when they're older and less healthy...?

Dr. Howard Njoo: At this point I don't think we have enough--

Mrs. Brenda Chamberlain: When you're above 50, you want to know.

The Chair: We want precise instructions here, to go out in the back yard or to stay in the house all summer.

Dr. Howard Njoo: At this point I don't think we have enough scientific evidence to make a recommendation around that. I don't want to frighten people, and some of my colleagues who read the literature can maybe back me up.

We're talking about the history of West Nile virus. There have been recorded outbreaks in the past in Europe and in places like Israel. What has become apparent is that the outbreak this past summer in North America, the United States, and Canada is the largest recorded one in history in terms of encephalitis and so on. What's becoming more evident is that it appears to be a more virulent strain, or at least the outcomes are more severe in what's happening in North America, compared to other recorded outbreaks in the past.

At this point it's something we're still trying to get a handle on. Therefore, in terms of whether you want people to get bitten, I think our recommendation would be that you should be trying to take personal measures to avoid getting bitten by mosquitoes.

The Chair: Most of the people who died, did they actually die of encephalitis or one of these other diseases that the virus led to?

Dr. Howard Njoo: The virus was--

The Chair: Or was it actually said they died of the virus?

Dr. Howard Njoo: A lot of it is very clinical. I don't have individual patient information. Of the eleven deaths, I'm aware that autopsies were performed on a number of them, and the virus was actually isolated from, let's say, the lining of the brain. In that sense, although I'm sure there are other contributing factors in terms of the person's immune status, in terms of cause and effect, I would say that certainly West Nile virus played a major contributing role in terms of that person's death.

The Chair: Now, of the cases I read about in the paper in the Toronto area on the shores of Lake Ontario, most were probably within two miles of the lakeshore. They all were seniors. Do you know if any of these eleven were not? The woman with the blood transfusion would be different.

A voice: 50-plus.

The Chair: No, I think they were older than that. I think the cases around our area were over 65.

» (1715)

Dr. Howard Njoo: We don't have accurate data in terms of very specific information on individual cases. We're still in the process of trying to receive that from the provinces. My understanding from the cases I'm aware of is that most of the individuals affected were older than, let's say, age 30. I don't have the exact ages of them. I'm not sure what you consider old or young.

The Chair: It would be nice to find that out.

Dr. Howard Njoo: They're mostly, I would say, depending on your definition of senior, over the age of 50.

The Chair: Over 65 is the typical age for seniors.

I had another question here. I'm worried about this choosing a vendor who doesn't have a product yet. What you've done is you've chosen a vendor because that vendor's test requires certain kinds of equipment for testing that you have to get in place. But what if he falters?

Dr. Graham Sher: If I may, Madam Chair, could I reply?

It's not that we've chosen completely in the dark. There were two vendors available to choose from. We met with both. We had extensive exploration of the technology they're offering, the sensitivity of the test that they anticipate having, their timelines to deliver the necessary equipment and the test kits and the reagents to use on that equipment. We did extensive investigation with both vendors.

We have a working relationship with one now, Roche. We made the decision to go with that company bearing in mind many factors, not least of which is their capacity to help us get this test in place in time. But as Dr. Vamvakas said, there are risks to this not being ready by July 1, because they are under development as we speak.

The Chair: Okay. Just one more question.

From what you know about this, it seems to be a weird virus, because some people get it, exhibit no symptoms, and are finished with it a few days later. It doesn't stay in the body. Other people have a little bit of flu-like symptoms. Then there's this huge gap on the spectrum of illness for these other people, who die. So we don't know of any other symptomology.

It would seem to me that depending on the severity of the number of mosquito bites or the viral load, let's say, that gets into your system, there should be a spectrum of symptomology that would go from absolutely no effect on a super-healthy person to death. But it just seems to be either one way or the other. There's no indication of it staying in the skin or something before it goes into the system and then makes it way to the brain or any of that kind of thing. You don't know anything about that--or do you?

Ms. Julia Hill: There isn't enough information at this point to be able to really give you a good answer. When I refer to it as being a sneak attack, there are a lot of things that are sneaky about this virus thus far: why most of us don't exhibit any symptoms, and why some people die from it. There's some speculation, but there really isn't enough information yet.

That's part of the discussion that happens when we meet with our colleagues in the U.S. as well, where they've been putting a lot of thinking around this too. It just isn't there yet, and that's a frustration we all have.

The Chair: Thank you.

Dr. Ganz.

Dr. Peter Ganz: Speaking to that point, it's important to realize that a lot of research needs to be done. A significant proportion of the workshops we had in early January hosted by Health Canada were devoted to discussions precisely aimed at answering the kinds of questions you are proposing.

We tried to focus some of the academic community and international community on carrying out some research in that area so we would be better informed. Does it take one mosquito to infect you, ten mosquitoes, or a two-week trip in Algonquin Park, versus trimming your cedar hedge in the back yard? We don't know the answers to those questions. Clearly there is a need to have more research done in that area.

The Chair: Thank you.

I think Mr. Merrifield has a short question, and then Ms. Skelton.

Mr. Rob Merrifield: I have two short questions.

If I get this right, you have a working relationship with Roche and hopefully they will get a test for you by July 1. Obviously there will be a dollar figure you know and a contract for each test, yet you've bounced that question around for an hour and a half. Are you now prepared to tell us what that dollar figure is? I think Francine said it was back in your office, but I'd like to know what it is.

Dr. Graham Sher: We are in contract negotiations with Roche now. They have estimated a price for buying the reagents to conduct the test. That's one part of it. You have to buy the equipment, renovate the labs, and train your staff. There are costs for transporting samples and changing your computer systems and databases to manage the data. There are many other costs built into the implementation of a screening test.

I can tell you this is going to cost CBS millions of dollars a year. Whether it's $10 million or $15 million, I don't know at this point, but that's the assessment that has been made. It's not going to be a penny a test.

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Mr. Rob Merrifield: All right, so after you renovate your labs and get everything ready to go, you don't really have an exact number on what it will cost per blood donation to be able to screen.

Dr. Graham Sher: We will know that once we have all the costs in hand.

Mr. Rob Merrifield: You don't know that now.

Dr. Graham Sher: No.

Mr. Rob Merrifield: Do you have an estimate?

Dr. Graham Sher: For CBS it will certainly be in excess of $10 million and may be double that, but I don't know with any certainty what it will be. I haven't finished my negotiations with the vendor yet. I may try to get a better price out of them.

Mr. Rob Merrifield: That leads me to the other question. I guess what disturbs me is that this has been around in North America since 1999 and we are now just starting to do something about a test for it. It seems like we're way behind where we should be. Maybe that's not a Canadian problem because it's only been in Canada for two years, but in the United States it has been around much longer than that. I'm a little surprised it hasn't been done by them.

Looking ahead, is there potential for developing a vaccine to protect the population, rather than testing every blood donor?

Dr. Graham Sher: Health Canada thinks there is that possibility.

Dr Francine Décary: To come back to the fact that it's been around since 1999, yes, it's been around for a long time. It was never felt that West Nile virus could be transmitted by transfusion or transplantation. As a matter of fact--I use this story all the time--when it started in the United States I asked my epidemiologist, who works with me at Héma-Québec in my office and is a microbiologist who loves all these stories, if he thought we were going to be stuck with this in transfusions. He said, “Oh, never. This is a mosquito-bird cycle. Once in a while you get a human, but that's it.” We've only known since August 2002 in the United States that it can be transmitted by transplant and/or transfusion.

Contrary to what you're saying, it is just amazing that we've known since August 2002 that this is dangerous to the blood supply and we're going to have something in July. If you think about AIDS, we've come a long way.

Mr. Rob Merrifield: That's fair enough. I guess we were all caught by surprise, and now we have to be as proactive as possible. I think it will be a real credit to the department and everyone if we can really accomplish this by July 1. But how far away is the vaccine, and how aggressively are you looking at it, or is it just a dream?

Dr. Peter Ganz: It's certainly not a dream, but I can only go by publicly available information, because it's still too early to have a submission for a vaccine in Canada—or even the U.S. But there is an American company that has gone on public notice to say it's developing a vaccine for West Nile virus, and it expects to have a commercial version of this vaccine available within two years.

The Chair: Mrs. Skelton.

Mrs. Carol Skelton: I have just a couple of things to say.

You are moving very fast. Is it correct that the Americans didn't know until last August and then informed you? When did the United States begin to worry about this?

Ms. Julia Hill: The confirmation from the United States to Canada came in the fall or late summer. But there have certainly been exchanges over the years on this and on a number of other factors. The whole challenge of the blood system is that there are constantly emerging pathogens, and you never know which ones are going to become an issue in the blood system and which ones aren't.

Mrs. Carol Skelton: You talk about the provinces funding you. Have you negotiated with your provincial counterparts, and are they giving you any levels or limits in funding this whole process?

Dr. Graham Sher: I can speak for CBS. To the credit of the provinces, when CBS was created in 1998 a mechanism was put in place that we don't need to go back to the provinces to deal with emergencies. We have the capacity to spend through contingency funds, which is a key underpinning of the safety of the system. In fact, it is one Justice Krever wrote extensively about. While they ultimately need to pay because this will go into the annual operating budget for next year, we do have the capacity to spend the dollars now.

Yes, we are in discussion with the provinces, because this will become a cost they will incur, since they pay for the operation of the system. But the point is that political decision-making is not going to hold up implementation of a safety test.

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Mrs. Carol Skelton: Very good.

With the drought the prairies have been having, I would hate to see us getting a wet year and see this spreading.

Thank you very, very much. I appreciate it.

The Chair: Thank you very much for coming.

If there's anything exciting in the way of...you might want to send us a little note, because we have to be kept alert. I'm still confused as to what I might put in my newsletter to my constituents, because it's hard to know. You don't want to scare people or to cause a panic or something.

Dr. Francine Décary: You can say the blood will be safe.

Dr. Graham Sher: If I may, Madam Chair, I have a second and very important message: your constituents must continue donating blood. If people stop donating blood out of concern for what's going on, the outcome will be much worse for Canadians in terms of blood shortages. So I think the message is that there are issues and risks, but people must certainly continue donating blood.

The Chair: Thank you very much.

Ms. Hill.

Ms. Julia Hill: There is also a Health Canada website that does have advice on public and population health information.

Howard, do you have the website's address?

Dr. Howard Njoo: It starts with the usual www.hc-sc.gc.ca.

Ms. Julia Hill: So it would have information intended for the general public on West Nile virus. You may find that helpful in communicating with your constituents.

The Chair: Thank you very much.

This meeting is adjourned.