Proceedings of the Standing Senate Committee on
Social Affairs, Science and Technology
Issue 13 - Evidence - October 6, 2010
OTTAWA, Wednesday, October 6, 2010
The Standing Senate Committee on Social Affairs, Science and Technology met
this day at 4:14 p.m. to study Canada's pandemic preparedness.
The Honourable Art Eggleton (Chair) in the chair.
The Chair: Welcome to the Standing Senate Committee on Social Affairs,
Science and Technology.
Today, we continue our study of pandemic preparedness, and specifically
vaccines, antivirals and adverse reactions.
We have three panels over a three-hour period. We will hear from Public Works
and Government Services Canada for the first hour, then Health Canada and the
Public Health Agency of Canada, and the third panel will involve various
pharmaceutical companies involved with vaccines and antivirals.
We have three witnesses from Public Works and Government Services Canada: Tom
Ring, Assistant Deputy Minister, Acquisitions Branch; Henry Kreker, Manager,
Influenza Vaccine Project; and Francine Brisebois, Senior Director, Commercial
and Consumer Products Directorate.
Tom Ring, Assistant Deputy Minister, Acquisitions Branch, Public Works and
Government Services Canada: Mr. Chair, I am pleased to be here today and I
thank you for the opportunity to appear before this committee to address the
role of Public Works and Government Services in the procurement of influenza
vaccine and antiviral drugs for the study of Canada's pandemic preparedness.
You have introduced my colleagues, but I would like to note that Mr. Kreker
has been involved in the vaccine program for over 10 years and is probably
considered expert across the country in the acquisition of these particular
We are here to answer questions you may have related to the procurement of
influenza vaccine and antiviral drugs as it pertains to the pandemic
preparedness strategy. I will be discussing the following points with you today.
I would like to provide you with some general background on the procurement
processes with respect to vaccines and antivirals. I would like to provide you
with a brief history of the FPT Group Purchasing Program for drugs and vaccines,
the procurement process specific to pandemic and annual influenza vaccines and
the procurement of antiviral drugs.
As you may know, Public Works operates as a common service agency for the
Government of Canada.
Our activities are directed towards providing services and support to the
programs of other government departments, boards and agencies.
The acquisition process requires that our clients define their operational
requirements, including the essential characteristics of the goods or services
Upon receipt of these requirements, we examine the potential sources of
supply, identify applicable contracting issues and develop a contracting
approach. In all of these steps in the process, we follow the government
contracting policies and regulations; we pursue this in a manner consistent with
the principles of fairness, openness and transparency, and all the while with an
eye to maximizing value for Canadian taxpayers.
The FPT Group Purchasing Program for drugs and vaccines was launched in 1973
to allow all jurisdictions to benefit from these activities and the cost savings
through economies of scale. As part of the program Public Works purchases
influenza vaccines on behalf of all provinces and territories and six federal
departments. We base these purchases on the estimates provided to us by each
jurisdiction. Each province and territory is responsible for setting their own
parameters for their individual vaccine campaigns.
In 1998, Canada began planning to establish domestic pandemic preparedness in
the event of an influenza pandemic. In 2000, a request for proposals was
publicly posted to invite members of the vaccine industry to submit bids to
establish a domestic pandemic influenza vaccine supply. Only one company was
interested in establishing sufficient domestic capacity to manufacture enough
vaccine to inoculate the entire population in the event of an influenza
Following the evaluation of its bid, Canada awarded a 10-year contract to
Shire BioChem Inc. This contract also guaranteed that the company would supply
50 per cent of Canada's annual influenza program needs. The remaining 50 per
cent is purchased through two separate contracts, and these contracts are split
evenly between GlaxoSmithKline Inc. and Sanofi Pasteur.
The ownership of the Canadian manufacturing facility is now owned by ID
Biomedical Corporation, which is a wholly owned subsidiary of GlaxoSmithKline.
Under the current pandemic influenza contracts, Canada pays a yearly pandemic
readiness fee, and a per dose price, upon purchasing the pandemic vaccine. The
pandemic readiness fee is paid to maintain all the necessary materials and
personnel to produce enough vaccine for all Canadians if an influenza pandemic
were to occur.
The existing vaccine contract has been extremely successful in delivering
high quality products at very competitive prices. It is important to note that
we have had full priority access to pandemic vaccine. This means that the
manufacturer must supply Canada's order before it can distribute any of its
vaccine to other clients.
The need for domestic manufacturing and full priority access was never more
evident than it was last year during the H1N1 outbreak. In fact, Canada was one
of two countries that had enough vaccine for its entire population by December
15, 2009. The United States was not in the same position as Canada despite
having contracts with five different suppliers. Mexico, relying on offshore
manufacturing, had only 750,000 doses, despite being the country to record the
first case of H1N1. Canada had amongst the highest vaccination rates in the
The three contracts for the supply of annual influenza vaccine have also been
highly effective. Canada's contractors have supplied all jurisdictions with
timely delivery of highly effective products at relatively low prices.
All three contracts for seasonal and pandemic influenza vaccine will expire
at the end of March 2011. We are currently in the re-procurement process. As
this re-procurement process is ongoing, unfortunately we will not be able to
discuss any of the details of the results, as the evaluation of the bids is not
Canada has gained a wealth of experience over the last 10 years, culminating
with the H1N1 pandemic. Our experience, as well as multiple independent studies
on the risk assessment pertaining to the threat of border closures and embargoes
during a pandemic, demonstrates the importance of having a domestic primary
The experience from H1N1 also highlighted that although domestic supply is
vital, a contract with a backup supplier could be prudent if there were
production problems with the primary supplier. Our re-procurement process
addresses this concern by exploring the feasibility of this concept.
In combination with influenza vaccine, antiviral drugs are also an important
part of our program. The government purchases of antivirals have largely gone
into two stockpile systems in Canada. The federally owned and funded, National
Emergency Stockpile System, (NESS), provides a rapid response to support the
efforts of provinces and territories to manage an influenza pandemic. The second
stockpile is a provincially and territorially funded and administered supply of
During the 2009 pandemic, antiviral drugs were important in combating the
first wave of the influenza. The stockpile proved helpful in combating H1N1 and
will continue to be a key part of the pandemic preparedness strategy.
In conclusion, we consider that the bulk-purchasing program for drugs and
vaccines has been a well-executed strategy.
We have cooperation among the various members of the
federal-provincial-territorial groups and solid working relationships with our
suppliers. We are collaborating with our clients and suppliers to strengthen
further our strong program for pandemic preparedness in Canada. We will be
pleased to respond to any questions you may have.
The Chair: The previous procurement involved only one company showing
interest but you ended up with three companies. I guess it is down to two with a
takeover of one by another.
How did that happen? How did that come about that you started with only one
company but then ended up with three?
Mr. Ring: For clarification, there was a request for proposals for
pandemic preparedness and pandemic vaccines in 2000. Only one supplier expressed
an interest and that was Shire BioChem, so we entered into a contractual
relationship with them.
Part of that process where they would have the pandemic readiness and supply
of vaccines was that they would also get 50 per cent of the annual influenza
vaccine. That was part of making sure they had the capacity within Canada; if
you do the pandemic readiness and assure us that we will have a domestic supply
of pandemic vaccine, you will be guaranteed 50 per cent of the annual influenza
The other 50 per cent was competed separately, and two bidders that split the
final 50 per cent. GlaxoSmithKline won 25 per cent and Sanofi Pasteur won the
final 25 per cent.
The Chair: What happened en route? In the first instance, only one
company expressed an interest and then you went out for other bids. You assured
them 50 per cent.
Mr. Ring: That is the pandemic.
The Chair: How did the other two companies come on if they were not
interested in the first place?
Mr. Ring: They were not interested because they were not able to
demonstrate they would have a domestic capacity for the pandemic. The condition
for the first 50 per cent was that they would have a domestic pandemic readiness
capacity. We were looking for a guarantee that the company would be able to
produce the pandemic vaccine domestically.
The Chair: You did not have to ask for that guarantee on the second
two companies, correct.
Mr. Ring: The second two companies' bid was about the annual influenza
vaccine, not the pandemic.
The Chair: One of the issues we hear a lot about is the notion of a
single supplier. A number of comments suggest that is unwise. Notwithstanding
the three suppliers, I guess you still have a single supplier for pandemic
Mr. Ring: Correct.
The Chair: What are the advantages and disadvantages of having that
single supplier? It sounds like a risky business.
Mr. Ring: There are two sides to that particular debate. In the first
instance, having a guaranteed domestic supply of pandemic vaccine proved to be
enormously important to Canada. There were examples in other countries where
they did not have a domestic supplier and were not able to get the kind of
vaccines they needed during the course of the pandemic.
There are issues with respect to embargo, where countries, for their own
domestic supply, will not allow exports of vaccines. Canada has a very
favourable arrangement with a domestic supplier.
As I noted in my opening comments, because of some of the issues around
whether there are potential problems with your pandemic supplier, we are looking
at a potential for a backup and looking at the feasibility and the cost of a
secondary or backup pandemic provider. However, that would likely be offshore;
and then you will have a risk that if you need the vaccines, you may not be able
to get them during a pandemic.
The two sides of the equation are the extra insurance of having a backup
supplier, but in Canada's particular case, that backup supplier will be
The Chair: You have no possibility of a backup supplier in Canada, is
Mr. Ring: We have asked. When we went with our re-procurement for the
domestic supply, there was only one respondent in Canada and that was GSK.
The Chair: Is that on the current supplier?
Mr. Ring: On the current re-procurement.
Henry Kreker, Manager, Influenza Vaccine Project, Public Works and
Government Services Canada: Canada's preference would be to have more than
one supplier in Canada. That is why when we went out with the bid solicitation
documents in 2000, any of the six or seven large international manufacturers
could have bid on that requirement. It was open for them to bid but only one
came back with a proposal to establish capacity in Canada.
Capacity in Canada is paramount, as Mr. Ring indicated, because several
studies conclude that there is a very high risk of contractors from abroad not
being able to supply the vaccine. That is because domestic governments where
those contractors are located would want to ensure their home populations are
satisfied before they allow export of a potentially lifesaving vaccine.
The Chair: If you cannot get a second supplier within Canada, is it
better to have other possible suppliers outside the country for backup?
Mr. Kreker: That could be the case, depending on the cost, obviously.
What is the risk of it coming to Canada even though they are contractually bound
to do so? Would they be allowed to export the vaccine? That is what we are
grappling with now. What is the cost associated with paying all that money in
advance and then, when the pandemic comes, you may not receive the product that
you have paid for? Those are the types of issues we are considering.
The Chair: As you pointed out in your opening remarks, Mr. Ring, the
vaccine was available for the entire population by December 15. Many people did
not think that was good timing; they thought that was rather late. Given that
there was a 45 per cent take up, it raises the question why the rest of the
population did not do it. According to the Statistics Canada report that came
out last week, it is because they did not think it was necessary. One of the
reasons I heard that they did not think it was necessary was because they
thought it was rather late.
Supposedly, you have a guaranteed supplier who is supposed to go to you
first, so why was it so late in getting into the field?
Mr. Ring: That is an excellent question. There was a phased delivery
of pandemic vaccine that started as early as October, and other witnesses who
will come later will be able to answer questions with respect to the provincial
and territorial vaccination programs and how vaccines were transported and
The contractual arrangement we had with the supplier was to provide a
significant quantity of vaccines beginning in October. There were, in fact, some
early production difficulties with the vaccine. Those problems were overcome
quickly. In fact, when I say that in December there was enough to vaccinate the
entire population, which was well beyond the requirements that were established
by the various federal, provincial and territorial health organizations. We feel
that the contractual arrangements we had in place met the needs of the Canadian
population. I think Dr. Butler-Jones said the same thing when he appeared before
you last week.
Senator Eaton: As you know, we are here to know how to do it better
next time. I live in Toronto. I was lucky to get the vaccination very early on
at St. Michael's Hospital. I think many people were perhaps put off because of
the lineups; they were never sure they would get the vaccination. You could sit
in City Hall and wait for two hours.
Once you provide the provinces with the vaccination, they are responsible for
the planning, coordinating and delivering of the vaccination. What did we learn
the last time? Are there recommendations we could give the provinces? Some
provinces gave the vaccination in schools and workplaces, which seems to me to
be very efficient. Toronto seemed to be a bit of a mess in the way it
administered the vaccine in terms of getting people to come to sites and then
wait in line for hours. Are you the people to answer the question concerning
what we learned and what we can do better?
Mr. Ring: We are interested in learning anything from our experience
last year that will improve our collective responsibility federally and
provincially for undertaking the actions that are needed to protect the health
and safety of Canadians.
For us, transportation of the products that we acquire is a key part.
However, your question is probably better directly addressed to some provincial
organizations in terms of their vaccination programs. If those vaccination
programs were in fact provincially organized and delivered, some of the health
officials later on this evening might be able to answer that question.
I will ask Mr. Kreker to speak to the process in terms of explaining to the
committee the transportation from the supplier.
Senator Eaton: Were all the provinces supplied at the same time? Were
they told how much of the vaccine they were getting and what they could expect?
Do you have recommendations for the next time?
Mr. Kreker: We are working closely with the supplier and all the
provinces and territories in determining how much vaccine should be shipped to
each of the provincial and federal jurisdictions. Under the contract, the
supplier has committed to supply certain quantities, and those quantities were
established in 2001. It was supposed to be a rate of approximately 2 million
doses per week, totalling about 8 million doses per month starting in
mid-November, the contract start date.
That schedule was changed slightly in October 2009 because of the high
visibility and demand. We met with the supplier to ask if they could speed up
that schedule, and they in fact started delivery towards the end of October
rather than mid-November, the time frame that they were supposed to start. They
were to deliver vaccine at a rate that we negotiated, which was slightly better
than the original contract. The supplier had some minor hiccups with the
start-up process but as Mr. Ring indicated, that was corrected quickly, they
were back on track, and we had sufficient vaccine for everyone by mid-December.
Concerning transportation, every lot that comes off the production line,
usually about 500,000 doses, is then allocated among the various jurisdictions.
A decision as to how much each jurisdiction receives is made between the federal
government and the provinces. They contact us and say that a lot is coming off
the production line, there are 500,000 doses, and we advise how much should be
shipped to each jurisdiction and where in that jurisdiction it should be shipped
to. After the lot is received by the provincial jurisdiction, that jurisdiction
is responsible for distributing that vaccine and actually doing the
Senator Eaton: Do you think that as the federal department you should
come up with recommendations as to how, in a future pandemic, the vaccination
should be administered? It was different and chaotic in each of the provinces.
Surely, someone in Health Canada is pulling together all these experiences. The
provinces, of course, do not have to follow your recommendations, but should
there not be some kind of recommendations that go forth from this experience?
Mr. Ring: I do believe someone from Public Safety appeared before you,
and I know that Public Safety has undertaken a significant lessons learned
program with respect to the whole experience. I would have to check on the
details, senator — I would not want to mislead you — as to whether those kinds
of recommendations would have been in the federal lessons learned report with
respect to the H1N1 pandemic.
Senator Eaton: One of the things I have learned sitting on these
committees is that we live in silos in this country. One province does not tend
to learn from the other in terms of best practices. That is why I think this is
Mr. Ring: I do believe that early on there was a recognition that a
lessons learned report was important to look at all the things that could be
done better, keeping in mind, as you have heard from Dr. Butler-Jones, that
there is a pretty significant feeling that it was a successful response.
Senator Eaton: That is not what I am saying.
Mr. Ring: It is important to us as well, hence the re-procurement
examination of the feasibility and cost effectiveness of a backup pandemic
Senator Merchant: Thank you to our presenters.
You made a comment about maximizing value for Canadian taxpayers. Who is
responsible for funding of the vaccine? Is it the federal government, the
provinces, or is it a shared responsibility?
Mr. Ring: It is a shared responsibility.
Senator Merchant: Is it 50-50, or do you know?
Mr. Kreker: The seasonal vaccine, which is the vaccine administered on
an annual basis, is paid for by the provinces and territories. The pandemic
vaccine purchased last year for the influenza pandemic was a shared cost. It is
a one-time agreement between the federal government and provinces, where the
federal government paid 60 per cent of the cost of the pandemic vaccine and the
provinces paid 40 per cent.
Senator Merchant: You said you had enough pandemic vaccine to
vaccinate every Canadian. At the same time, we know that less than 45 per cent
of Canadians were vaccinated. What did you do with the leftover vaccine? In
addition, you had also stockpiled about 55 million doses of anti-virals. What
happens to these vaccines and what is the standard of efficacy that we use in
Canada for the vaccines?
Mr. Ring: I apologize, senator; both questions will have to be
answered by health officials. As the purchaser, we acquire the vaccines, they
are provided to the provinces, and that is where our responsibility ends.
Senator, you have asked a very good question. I believe people will have the
answer in terms of what happened to the unused vaccine. That question is not one
I can answer.
Senator Champagne: Our chair mentioned earlier, and it has been said
before, that we were all a little disappointed that only 45 per cent of
Canadians took advantage of our offer and got the pandemic influenza vaccine.
Yet our government actively advertised to encourage people to get the
vaccine. I think Quebec was definitely the province with the best response. I
think the percentage of people who got the vaccine was the highest.
As Senator Eaton mentioned, people would go, line up and wait for hours, and
then they were often told: "Well, that is it for today, go home and come back
tomorrow." We were told that it was because the vaccine had a very short shelf
life. For those who went to the clinic, the vaccines were only good for a few
hours. After that, people could no longer be vaccinated.
Is it true that the vaccines you purchased had a very short shelf life? Was
distribution insufficient? I even heard that people my age were pushed back very
late before they could get it. I go back to the people who stood in line for
hours on end just to be told: "We have to close for today because the vaccines
are no longer any good since we have had them for too long." Was that an excuse
or the truth? That is what I would like to know.
Mr. Ring: I am not actually the right person to answer these
Senator Champagne: But it was you who ordered the vaccine.
Does it have a short shelf life or not.
Mr. Ring: No, not necessarily within a day or two. The shelf life,
according to the contract, was a long period of time. I have not heard of the
suggestion that clinics were closed because of a shelf life issue, but again,
that would be a question to address to medical professionals. The shelf life
that was in the contract was 18 months, not 18 hours or several hours.
Senator Champagne: Your answer reassures me. That is what was said in
the news and the papers. Those people were sent home because the vaccines were
supposedly no longer good. These types of vaccines should not be purchased. You
are the one who bought them.
Senator Ogilvie: My questions are for clarification on the overall
Based on the document that you read to us today, do I correctly understand
that on the contract that we are discussing from the past, if we were to look at
it currently, we had one supplier who had 100 per cent of the pandemic vaccine
production and as a result of reconfigurations in the industry that supplier
wound up with 75 per cent of the annual vaccine product and then the other
supplier had 25 per cent?
Mr. Ring: That is correct.
Senator Ogilvie: The second part of that moves on to the current
process and your comments on your current RFPs. Did I hear correctly that we are
currently looking at a dialogue with one company for 100 per cent of both
pandemic and annual vaccine?
Mr. Ring: No, in August, we sent out two RFPs on the government
electronic tendering system. The first was entitled a domestic pandemic and
annual influenza vaccine supply and the second was just for annual vaccine
supply and a backup pandemic supply. Does that answer your question?
Senator Ogilvie: I understood you to say, and perhaps this is where I
made the error in interpretation, that you received only one response to your
Mr. Kreker: As Mr. Ring indicated, we sent out two proposals. One
proposal called for bids for a domestic supplier for pandemic vaccine, which
would be the primary supplier. That primary supplier would also be given a
certain percentage of the domestic seasonal vaccine market. Another proposal
asked for a backup supplier in the event of a pandemic, not necessarily a
domestic backup supplier. Our preference would be a domestic supplier, but
experience has shown us that it is probably too expensive for manufacturers to
build new facilities in Canada. We noted the concerns of Canadians about putting
all our eggs in one basket. We are looking at the feasibility of having a backup
pandemic vaccine supplier, even though that supplier is located abroad and may
be subject to embargo should there be a severe outbreak and that government
decides to take care of its own citizens before it allows the export of the
Senator Ogilvie: I understand all the complications with regard to an
outside supplier. I thought I heard you say you only had one response to your
RFPs. I want to know what that meant. I understood it to be to both your RFPs.
Mr. Kreker: We have had more than one response, but we are evaluating
those proposals. We cannot go into details, but we have more than one response.
Senator Ogilvie: You have more than one response to both RFPs?
Mr. Kreker: Together we have three suppliers that have responded
between the two RFPs.
Senator Ogilvie: Thank you. That is substantially different from how I
interpreted the comment as it came through. That is good.
Looking at our domestic capability, I understand what you said concerning the
response for supply to the previous pandemic. I understand more clearly, what
you said concerning the response to your current RFPs.
In looking at the Canadian capability, how many companies operate within
Canada with facilities that could potentially have produced 25 per cent of our
annual influenza vaccine production?
Mr. Kreker: To my knowledge, there is only one supplier that
manufactures influenza vaccine in Canada. You have to keep in mind that the
manufacturing means that they have to produce the complete vaccine in Canada.
The egg suppliers must be located in Canada, et cetera.
One supplier presently manufactures everything that is required for influenza
in Canada. There are other suppliers in the vaccine manufacturing business that
could get into producing influenza vaccine in Canada. If they chose to do so,
they could bid on the contract and build facilities or convert existing
facilities from manufacturing another vaccine to the manufacturing of flu
vaccine, including fill and packaging capacity. However, they have not expressed
an interest in quoting on domestic supply.
Senator Ogilvie: I understand. I want to come back to the issue of
your evaluation of the Canadian capabilities in this area. I fully understand
the steps, involved in the vaccine production. I also understand the limited
number of suppliers that have responded.
If they were so inclined, how many Canadian companies do you feel could
potentially respond to a production of 25 per cent of our annual flu vaccine?
Mr. Kreker: You are probably aware that we had an industry
consultation in March before we issued the bid solicitations for Canada's
requirement and the provincial requirements. Six suppliers attended that
consultation. There was an additional supplier that chose not to attend. It is
my belief that if any one of those seven suppliers had chosen to build
facilities in Canada, they could have done so.
Senator Ogilvie: Thank you. That is it exactly. I was looking for the
answer I believe I now have.
Mr. Kreker: Any one of the seven suppliers could have bid on the
Senator Callbeck: Thank you for your presentations. I refer to page 5
in the brief on costs. It says that under the current pandemic and forensic
contract, Canada pays a yearly pandemic readiness fee. How much is the fee?
Mr. Kreker: The individual pricing negotiated with the companies is
considered commercially confidential. I cannot disclose that fee without the
permission of the party that is signatory to the contract.
Mr. Ring: That person is appearing later this evening, so you might
want to ask him.
Senator Callbeck: There is a readiness fee and a per-dose price. The
brief says that Canada received these at a very competitive price.
Mr. Ring: Yes.
Senator Callbeck: Can you tell us the total cost, including the
readiness fee, and compare it to other countries?
Mr. Ring: Mr. Kreker will have more than ample information for you.
His challenge will be not answering that question in a way that would release
that commercially confidential figure.
We have done comparisons of our price versus what other countries have paid
and we can make assurances about the reasonableness of the prices we paid.
Mr. Kreker: In our discussions with the industry, which included all
six suppliers that attended the industry consultations in March, the industry
indicated that the prices we currently pay for seasonal vaccine compare to
prices that will be paid by Third World countries, not rich Western countries.
The prices we paid for seasonal vaccine were extremely low in comparison to what
other Western developed nations paid.
For example, in comparison to our neighbours to the south who buy 10 times as
much seasonal vaccine as we buy, we paid less than one half what they paid. Does
that give you some assurance?
Senator Callbeck: That is great. On page 4, you discussed the amount
that was ordered for all the provinces. The figure was based on estimates
provided by each jurisdiction. How many doses were ordered?
Mr. Kreker: Is that for pandemic vaccine?
Senator Callbeck: Yes.
Mr. Kreker: We ordered 50.4 million doses of pandemic vaccine in
Senator Callbeck: Did you say 50 million doses?
Mr. Kreker: Yes, it was 50.4 million.
Senator Callbeck: Our population is not that great.
Mr. Kreker: We were purchasing a completely new vaccine to protect
against a virus never seen before. A pandemic vaccine is a new drug. Therefore,
when we ordered the vaccine, it had not been quite established whether a person
would require one dose to build the required immune response or two doses. Our
colleagues from Health Canada will be able to explain that in more detail.
At the time of ordering the vaccine for Canada and the provinces, it was not
clear how many doses would be required to afford the necessary protection to
citizens. There was a chance that we might need two doses of the vaccine per
person, as was the case with avian flu that circulated in previous years. We
could not take a chance on ordering only one dose per person in case it proved
to be that a two-dose regimen was required. That is why 50.4 million doses were
Senator Callbeck: When was it established that one or two doses would
Mr. Kreker: I believe that technical question is better addressed to
our colleagues, who will follow us on the next panel of witnesses.
Senator Callbeck: I do not know whether my next question should be
addressed to you or other witnesses on how the vaccines were packaged. Who made
the decision on the packaging format?
Dr. Donald E. Low, from Mount Sinai Hospital, appeared before the committee
last week. He talked about the problems faced by front line physicians with the
way the doses were packaged. Each vial carried 10 doses, which meant that after
mixing a vial, 10 shots had to be administered within 24 hours to avoid having
to throw out the remaining vaccine in that vial. In addition, the vaccine came
in packages of 500 doses, so any physician would have to give a minimum of 500
vaccination shots. Who made that decision?
Mr. Kreker: The packaging was decided by the manufacturer based on
their estimate that the vaccine would go to mass vaccination clinics. Therefore,
the manufacturer chose a larger rather than smaller package size. That
particular assumption proved to be wrong, as we experienced last season. We are
making adjustments in the new tender process to allow for smaller package sizes
that will be more convenient to our end users.
Senator Callbeck: That is certainly one thing we have learned.
The Chair: Does that mean smaller packages to go to physicians who did
not take advantage of the program because the sizes were too big? We have heard
Mr. Kreker: The package size will be determined in consultation with
the provinces and territories and officials from the Public Health Agency of
Canada, and the manufacturers' capability will be considered. For your
information, Canada represents less than 2 per cent of the vaccine market in the
world. The multi-national manufacturers ship, produce and manufacture vaccine
for shipment all over the world. The package size that is convenient in Canada
might not be convenient in other countries. If we were to specify a package
size, a manufacturer would have to put in a new packaging line. If it were
specific to Canada only, then the vaccine for Canada would be more expensive.
Given that Canada represents only 2 per cent of the market, the manufacturers
are reluctant to make that change. The suppliers also heard the same complaints
from other jurisdictions in other countries, so I am sure they will be able to
speak to the issue and let you know what arrangements they will make in the
future. Our preference is for smaller package sizes.
Senator Seidman: Mr. Ring, for clarification, on page 3 you say:
The acquisition process requires that our clients define their
operational requirements including the essential characteristics of the
goods or services being sought.
Could you clarify that statement please?
Mr. Ring: In summary, we do not determine what is required. We are
given the requirement. Our client will tell us what they need, and we will
acquire it. That is all it means. We do not determine how much vaccine a client
might need, for example. We do not make that determination.
Senator Seidman: Are you referring to the provinces and territories?
Mr. Ring: In this case, yes, because we purchase for the provinces and
territories, and six government departments — DFAIT, for example.
Senator Seidman: The provinces and territories are responsible for
planning, coordinating and delivering immunization programs. There are
differences in the vaccine programs across these jurisdictions. We know that
Canada is unique; for example, the U.S., Australian and the U.K. have
Did this present particular challenges for you? Is there anything you might
change, given the opportunity to do so?
Mr. Ring: Are you asking if combining the requirements from 13
different jurisdictions poses a particular challenge to the acquisition process?
I will answer in general terms but then I will ask Mr. Kreker to respond
specifically to last year's experience.
In general terms, I would have to say no, we would simply bundle the
requirements and that the entire purpose of the FPT bulk-purchasing program is
to get that economy of scale. We think we achieved that goal.
Mr. Kreker, with respect to last year, was there any particular problem with
the fact that the requirements came from multiple different jurisdictions.
Mr. Kreker: I do not believe there was any problem with communication
with the provinces or our federal clients. We have been running this particular
program for over 30 years. We meet regularly with our clients, all the provinces
and territories, as well as the federal departments, and we have telephone
consultations with them as and when required. The communication lines with the
provinces and territories, and with the federal departments, are well
established and they are very good communications lines. The program has
provided significant savings, especially to smaller jurisdictions, in product
cost savings, as well as administrative cost savings because they do not have to
do the procurements 14 or 15 times. They do it once and the economies of scale
obviously offer better pricing, as I had noted before.
From our point of view, they tell us how much they need and they get the
vaccine delivered. As Mr. Ring indicated earlier, for seasonal vaccines, in the
10 years I have been involved with the program we have not had any major
hiccups. As many of you probably noted, in 2004 there were boatloads of people
coming over from Seattle to Vancouver to try to get vaccinations because our
American neighbours were not as lucky. That is one of the main reasons they have
spent a lot of money, in billions of dollars, in trying to establish domestic
vaccine production capacity. Canada's expenditures to date have been minimal in
comparison to the expenditures made by our neighbours to the south.
Senator Seidman: On page 5, you say:
The ownership of the Canadian pandemic influenza manufacturing facility
changed hands in the past 10 years. The plant is now owned by ID Biomedical
Corporation, which is a wholly owned subsidiary of GlaxoSmithKline Inc.
Could you elaborate on that please?
Mr. Ring: When we signed the contract, Shire BioChem owned the
facility and it changed hands twice within that 10-year period. I do not know
who the intervening owner is but I am sure Mr. Kreker would know. Then
subsequently ID Biomedical purchased that facility and ID Biomedical is a wholly
owned subsidiary of GlaxoSmithKline.
Senator Seidman: Does that mean that the Canadian manufacturing
facility that we use to manufacture pandemic vaccine is owned by GSK?
Mr. Ring: Yes.
Senator Seidman: What do you think Canada's role should be in the
provision of vaccine to other countries, such as the developing countries?
Mr. Ring: It is difficult for me to opine on that question. That is a
question for our colleagues in Health Canada. Certainly as an acquisition agent
in acquiring these things, you let us know how much it is you want and what you
want to do with it and we will find it for you.
Senator Martin: From listening to your presentation and to the answers
to the questions today I wish to commend you on really doing your job, which is
to ensure that the supply was there for Canadians and we did have more than
I am from British Columbia and I know our rate was the lowest. The government
did its job in leading the horse to water, and I know friends and family who,
for various reasons, did not receive the vaccine. We can do only so much but
perhaps that is a question of educating and getting ready for the next pandemic
My question concerns capacity building. Although your role is to ensure the
supply is there, can you speak to what we may be doing to build that capacity. I
imagine that in looking at the overseas supplier, it would involve a more
You mentioned some lessons learned, but on page 6, you remark that we can
make the mistakes ourselves, or learn from the mistakes of others. Are there
lessons learned from other jurisdictions that may affect how you proceed with
the next pandemic outbreak?
Mr. Ring: I will try to respond to that in two ways with respect to
the lessons learned and the building capacity. Before I do that I actually would
like to thank you for your opening comment and I would like to suggest that
there is a system in place to make sure these things happen. It is public
servants like Mr. Kreker, who has been working on this for 10 years. Mr. Kreker
worked day and night to ensure this acquisition was done properly and on time.
Professional public servants such as Mr. Kreker deserve the credit and I will
thank you on his behalf.
On capacity building, through the acquisition process, one way to build
capacity in Canada, not only with respect to vaccines but also in our
acquisition of anything, is to declare well in advance, what the requirements
will be for a long period of time. We have done that in the particular case of
vaccines. We have a 10-year contract that gives the kind of long-term security
that private sector companies need in order to do the right business planning
and make a determination as to whether they will invest in the types of
facilities that would be required to produce any product. We have learned that
We have learned the lesson about planning. We learned the lesson about the
guaranteed domestic supply, about making sure your supply of pandemic vaccine is
provided from a domestic source. All those things together would suggest that we
are doing what we can to encourage the capacity building in Canada.
When we had the industry day in March, as was noted, six companies came. They
understood the requirements for a very long period. They understood the risks
and benefits associated with bidding on those requirements. I would say that the
system we have in place of a guaranteed supply, long-term contracts, are the
kinds of tools that help to build capacity within the industry.
In terms of looking at other jurisdictions and the lessons learned, that is a
good point. I do not have the answer. Again, as part of the government-wide
lessons learned, I will not suggest and I have not suggested in my comments that
we do not have some lessons to learn from a Public Works perspective, but more
broadly with respect to pandemic readiness. It is within the health professional
field. There are international organizations looking at sharing best practices
and ensuring the jurisdictions share that information. I believe that work is
actually being done.
Senator Cordy: We are indeed fortunate to be living in Canada and you
certainly get a better understanding of that when you travel to other countries.
In Public Works, you are strictly dealing with the procurement; you get the
contracts and sign them and then you distribute the product. Did you distribute
the vaccines directly to the provinces and territories?
Mr. Ring: I will ask Mr. Kreker to explain.
Mr. Kreker: Canada is very fortunate to have a domestic supplier that
can provide all the vaccine that we require for our citizens. We are one of the
few countries in the world that has that good fortune.
We were the model in 2001. The model we established is now being copied by
other countries. Based on Mexico's experience last year, it is my understanding
that they are investing $125 million to build facilities in Mexico to ensure
they have a vaccine earlier than January.
In terms of your question senator, we arrange for the delivery of the
vaccines, and the shipments for pandemic vaccine went directly to each
jurisdiction that needed that particular vaccine. The provinces tell us where it
is to be shipped and we make the arrangements to ensure it is shipped to that
Senator Cordy: I want to come back to Senator Callbeck's question
about 50.4 million doses ordered. Who made that decision? Was it Public Works or
Mr. Kreker: The decision as to the quantity of vaccine to be ordered
was made jointly between the provinces, territories and federal government
Senator Cordy: Did we have to pay for 50.4 million doses of vaccine?
Mr. Kreker: That was the original order. That order was reduced
significantly as we received the information. The actual quantity of vaccine we
ended up obtaining was significantly less than 50.4 million doses.
Senator Cordy: Statistics Canada tells us that 41 per cent of the
population received the vaccination, and Public Health says 45 per cent. Even if
we looked at 50 per cent of the population — and it was not that high — we still
would not need 50.4 million doses. If 50 per cent of the population received the
vaccination, we would need only 32 million for two dosages per citizen; and as
it turns out, we only needed one dose. Those numbers make me nervous to think we
would order that many doses for inoculation in Canada.
Mr. Kreker: That question is probably better directed to our
colleagues at Health Canada. However, I mentioned earlier that at the time it
was not clear whether w person would need one or two doses.
The health practitioners will be able to answer the question as to how they
arrived at that number. However, even after the order was placed, we did not
take delivery of the 50.4 million doses. The actual quantity was significantly
less than that number.
Senator Cordy: How many did we pay for?
Mr. Kreker: I do not have the exact numbers in front of me but I would
be more than pleased to provide those numbers to the clerk.
The Chair: How many did you actually buy?
Mr. Kreker: I think that is what the senator asked. We ordered 50.4
million doses, but we reduced that quantity as the information rolled in.
The Chair: But you do not know what you reduced it to?
Mr. Kreker: Some of the vaccine was bought in bulk and the adjuvant
was sold separately from the antigen. When you split those up and hold them for
future — some vaccine and adjuvant was stockpiled for future use.
The Chair: You will provide that information.
Mr. Kreker: Yes.
The Chair: We have run out of time but thank you very much for coming
and explaining your role as the procurement entity.
Our second panel will focus on people in Health Canada and the Public Health
Agency of Canada. Welcome to Meena Ballantyne, Assistant Deputy Minister, Health
Products and Food Branch, Health Canada and Elwyn Griffiths, Director General,
Biologics and Genetic Therapies Directorate, Health Canada. From the Public
Health Agency of Canada, we have John Spika, Director General, Centre for
Immunization and Respiratory Infectious Diseases and Dr. Barbara Law, Chief
Vaccine Safety, Centre for Immunization and Respiratory Infectious Diseases,
Public Health Agency of Canada.
Meena Ballantyne, Assistant Deputy Minister, Health Products and Food
Branch, Health Canada: Thank you honourable senators for the privilege of
speaking with you about the role of vaccines and other health products in our
response to the H1N1 outbreak last year.
I have with me Dr. Elwyn Griffiths, Director General of the Biologics and
Genetic Therapies Directorate, who will be speaking from the perspective of the
I have two other colleagues in the audience, Dr. Supriya Sharma, the Director
General of the Therapeutic Products Directorate, who handled the antivirals,
sanitizers and masks, as well as Dr. Chris Turner, who monitored the adverse
reactions to the antiviral.
To give you a little context, the Health Products and Food Branch regulates
health products. We attest to the safety, quality and efficacy of the vaccine,
of antivirals and some of the other health products that were used during the
outbreak last year. We ask are they safe to use? Are they manufactured under
good manufacturing practices? Do they do what they say they will do? We ask and
answer those questions before they are made available to Canadians.
Our goal during last year's pandemic was to help facilitate access to these
products. As one of the senators said, it seems like we work in silos, but we
all have our distinct roles and we are interdependent in providing access to
Our role in the Health Products and Food Branch is to authorize the vaccine
and the antivirals, so that Health Canada scientists have reviewed these
products and can attest to their safety, quality and efficacy. The Public Health
Agency of Canada, in collaboration with the provinces and territories, and with
our colleagues from Public Works and Government Services Canada is responsible
for managing the supply, and provides guidance on the use of these antivirals.
We determine how much is needed, when to roll it out and how to use it. Of
course, the provinces and territories are ultimately responsible for the
delivery, immunization programs, rollout and use of the vaccine.
Collaboration across all these organizations was critical in making the
vaccine and antivirals available as quickly and safely as possible throughout
last year's outbreak.
My colleagues will share what they learned in providing timely access to safe
and effective products.
I would like to highlight one of our successes, which was the expedited
approval of the pandemic vaccine without compromising safety. The assessment and
authorization of the H1N1 vaccine was critical for public health authorities to
begin their immunization programs.
For the first time in our history, we were able to approve a vaccine
literally as it was coming off the production line, without cutting corners on
safety. We were able to do this with extensive planning and collaboration with
our international counterparts. There was a lot of work and advance planning,
which Dr. Griffiths will speak about.
As you know, this was a global event that required a global solution. We had
a variety of memoranda of understanding with our partners in the U.S., the EU
and Australia. We had global clinical data. As they were using the vaccine in
these countries, they were giving us the data in real time so that we could make
decisions here about the vaccine we were assessing. We were able to assess in
real time whether the benefits would outweigh the risks of these products, which
is what we always do as a regulator, assessing the benefit-to-risk ratio.
My colleagues here and in the branch worked tirelessly around the clock last
fall, having daily conversations with the manufacturer. We had people at the
GlaxoSmithKline facility in Sainte-Foy, Quebec; we had testing going on within
our labs in Health Canada; and we were in constant conversation with our
As you have noted, our experience from last year also provides us with an
opportunity to improve our actions for the future. We continue to update our
plans and we flag areas for improvement, particularly in the way we communicate
our decisions and actions in emergency situations, when the need for information
is at its highest.
It is interesting to know that some of these same topics have been raised by
my international counterparts, such as improving the transparency of our
decisions and building a better understanding of the role of the regulator and
the public health officials.
Thank you again for this opportunity to shed light on our tremendous efforts
in responding to the H1N1 outbreak.
Elwyn Griffiths, Director General, Biologics and Genetic Therapies
Directorate, Health Canada: I would like to thank the committee for inviting
me to come here this afternoon to present. I think we should go back 12 months,
almost one year ago to the day, when Health Canada authorized GlaxoSmithKline's
Arepanrix H1N1 vaccine. This was a milestone in our efforts to protect Canadians
against pandemic influenza, and in this case, the pandemic was due to H1N1.
As Ms. Ballantyne indicated, we were able to review and approve this vaccine
in record time without compromising safety. I will share with you some of the
methodologies and how we overcame the challenges.
Indeed, there are unique challenges in relation to development and regulatory
evaluation of influenza vaccines in themselves, let alone a pandemic. The
challenges are magnified in a pandemic situation.
Influenza pandemics are caused by a virus strain not previously circulated.
They are novel, brand new, so we have not seen them before. A key challenge,
then, is that vaccine manufacturing cannot begin until the actual pandemic
strain has been identified and isolated. That is the first part. The time
available between completion of manufacturing and getting a vaccine into the
arms of Canadians to provide protection when it is needed is extremely short.
This is the problem, and it is a major challenge. This was recognized early on.
The ability to approve a safe and effective vaccine for an H1N1 pandemic for
Canadians in such a short time was due to two factors: advance planning and
extensive collaboration, much of it international. Health Canada and the Public
Health Agency of Canada had been proactively preparing for a pandemic for
several years. This preparatory work took place at both the international and
Between 2006 and 2007, Health Canada hosted regulatory preparedness
workshops, together with the U.S. Food and Drug Administration and the World
Health Organization. These workshops resulted in the development of WHO
guidelines on regulatory preparedness for human pandemic influenza vaccines and
it also created a global network of influenza vaccine regulators. This network
proved to be invaluable, as regulators worldwide were dealing with the same
situation as we had in Canada. This is not peculiar to Canada; it is global.
Domestically, there was close collaboration with the contract vaccine
manufacturer, GlaxoSmithKline. In the pre- pandemic period, Health Canada
evaluated a potential pandemic vaccine, which we call a mock vaccine. It was an
H5N1 avian vaccine, produced by GSK.
This mock vaccine enabled Health Canada to inspect the vaccine manufacturing
facilities to review the data on the quality, safety and efficacy of the
vaccine. Thanks to this advance planning, the safety and effectiveness of the
adjuvant was also assessed over this period in that pre-pandemic time by Health
Canada and by the other regulatory agencies. Again I emphasize that this was a
Once the H1N1 pandemic strain had emerged, vaccine manufacturing could then
begin and the regulatory approval process started. We reviewed information as it
became available. We call it a rolling submission. Normally with a vaccine or a
product coming in, the whole package comes in and that is it; we wait to have
all the data in together. In this case, we were rolling. As the data came in, we
were reviewing it.
The H1N1 vaccine was subject to the same stringent manufacturing and quality
oversight that is in place for any other vaccine. Extensive quality control and
product testing is required at multiple stages during the manufacturing process.
However, due to the uniqueness of the pandemic situation, all the safety and
effectiveness data regularly required for a vaccine were not available at the
time of licensure. This was the case in Canada and in all jurisdictions; it was
not peculiar to Canada.
Additional studies and surveillance continued post market in order to detect
any potential adverse events. During the pandemic, WHO hosted biweekly
teleconferences with the previously established network of regulators, and we
were in almost daily contact with the key regulators, for example, with the U.S.
Food and Drug Administration and European regulators. There was a tremendous
amount of international interaction.
Most importantly, there was a global commitment amongst the regulators to
share quality clinical and safety data on the H1N1 vaccines in real time, as
they became available. That is unusual. This was new. This enabled countries to
maximize the amount of data available to support approval of this vaccine.
Once immunization programs began worldwide, Health Canada and the Public
Health Agency collaborated with the World Health Organization and other
regulators to closely monitor the safety and effectiveness of the H1N1 vaccines
and communicated any potential adverse events following immunization in a timely
manner. We had all the information as it came out.
In conclusion, we had been preparing for a pandemic for several years; we had
a regulatory plan in place; and following the plan, we made it possible for the
vaccine to be developed and authorized within about five months following
identification of the pandemic strain without compromising the safety. This is
considered a great technical and regulatory achievement.
Advanced planning and global collaboration in the development and regulatory
oversight of a pandemic vaccine was essential for making vaccines available to
Canadians within such tight timelines.
We continue to collaborate internationally on vaccine regulatory issues. For
example, Health Canada, with the U.S. FDA and the World Health Organization
jointly organized a workshop on lessons learned from testing of the H1N1
pandemic vaccines in July and the meetings were held here in Ottawa. The
workshop focused on the use of alternative testing that could potentially
expedite even further the availability of vaccines. More research will be
required at that level.
Dr. John Spika, Director General, Centre for Immunization and Respiratory
Infectious Diseases, Public Health Agency of Canada: It is a pleasure to be
here to focus on Canada's experience with vaccines, antivirals and the adverse
events during the H1N1 pandemic. With me today is Dr. Barbara Law. She is head
of our vaccine safety group with my centre.
To preface my remarks, I will provide a few definitions.
A vaccine prevents illness. It stimulates the production of antibodies
against a virus. It is the ideal first line of defence against infection.
Canada, as you have heard, has had a contract in place to ensure vaccines for
all Canadians who want and need them during a pandemic.
Antivirals are there to treat illness. They work by interfering with the
replication of the virus in an already-infected person. Canada has a national
stockpile of antivirals at the ready in the event of a pandemic. I know
questions came up earlier and hopefully we can address them as we go forward.
Both vaccines and antivirals are important parts of our pandemic response.
Preventing needless illness through immunization is the cornerstone of Canada's
health response to pandemic influenza.
Throughout the pandemic, the Government of Canada and the provinces and
territories were committed to providing pandemic flu vaccine to every Canadian
who needed and wanted it.
As you have already heard, Canadians did have access to H1N1 vaccine sooner,
in greater volume and at lower cost than almost any other country. If necessary,
we can provide more information in that area. Thanks to years of planning with
all partners and to the response of Canadians, we successfully completed the
largest immunization effort in Canadian industry. That is no small feat.
The collaboration aspect is crucial. Immunization is a shared responsibility.
The federal government facilitates health system preparedness, provides national
leadership and guidance, and exercises the regulatory function to approve
vaccines. Provinces and territories deliver health care services to the
population during a pandemic and deliver vaccine through local health
authorities. Of course, it is then up to each Canadian to make the effort to be
Given this, securing the vaccine to begin with was a critical step in our
planning. As you have heard, after 2001, after developing a question for
proposal we ended up with a contract for domestic vaccine that was awarded to
the company that is now owned by GlaxoSmithKline. This ensured all Canadians who
wanted and needed it would have access to the vaccine.
All jurisdictions wanted this certainty and security.
Our experience showed that it was much better to plan for it, rather than
face the risk of last-minute scrambling for supplies, competing with other
countries, or facing the risk of a product being stuck at the border crossings.
The contract was unique in the world at the time. It ensured sufficient
infrastructure and capacity to produce 100 per cent of our domestic supply
needs. New vaccines typically take years to be authorized, but thanks to
advanced planning, Canada was able to move quickly. As you have heard from Dr.
Griffiths, the company knew in advance what safety data requirements it had to
meet for its H1N1 vaccine to be approved.
From identifying the virus in our laboratories at the Public Health Agency,
to developing a seed strain, to clinical trials and authorization, Canada had a
H1N1 vaccine in only a few months.
Our original order of 50.4 million doses, announced in August 2009, was
informed by the best domestic and international scientific and epidemiologic
evidence available at the time. Again, I will be pleased to respond to any
specific questions you may have about how that number was derived.
In September 2009, we published our sequencing guidelines for vaccine
delivery. We all understand that even with our vaccine production capacity it
was physically impossible to have everyone immunized at once. After approval in
2009, while other countries were still waiting to secure their vaccine supplies,
our immunization efforts were in full swing.
Jurisdictions gave out more vaccine per day than they had ever given out in
history. One hundred per cent of First Nations communities held immunization
clinics, and across the country health care professionals worked tirelessly and
around the clock to get shots in arms under very challenging and unique
circumstances. These are the reasons Canada achieved one of the highest
immunization rates in the world with 45 per cent of Canadians receiving the
vaccine. Children and on-reserve First Nations saw even higher numbers of
uptake. We were also able to carry out nationwide surveillance to ensure vaccine
Antivirals helped reduce the severity of illness in those infected.
Canada had a contract in place to monitor antiviral prescriptions and
over-the-counter medicine use. We had existing national guidance on antiviral
use posted on the Public Health Agency website for risk groups, health care
workers, and for those caring for someone ill at home.
During the second wave, we saw fewer patients requiring hospitalization who
were admitted to the ICU, and although we saw four deaths during the much
smaller first wave, we saw no deaths among pregnant women during the second
Earlier and more aggressive treatment with antivirals surely played a role.
It is thanks to years of planning for those critical public health interventions
that the effect of the pandemic was minimized in Canada, but it was not an easy
balancing act. Hundreds of difficult decisions had to be made, even as the
evidence and science changed, for example, between adjuvanted and unadjuvanted
vaccines. We could not recommend adjuvanted vaccine for pregnant women until
there was sufficient evidence on its safety and effectiveness. This was one
example of how even years of solid planning are not immune to changing science
and lead to delays in how everything rolls out.
Looking ahead, the Government of Canada will pursue a new long-term pandemic
vaccine contract, as you have heard, that reflects on our lessons learned.
Honourable senators, during the H1N1 pandemic we informed Canadians of the
decisions that we made every step of the way. The Chief Public Health Officer
had access to all the relevant information necessary to support informed
decisions on all H1N1 vaccine matters. This information reflected the latest
scientist evidence and was shared in a timely way with all provincial and
territorial counterparts, all of whom contributed to and supported the decisions
We were upfront with everyone about the global challenges with which we were
dealing. We worked in concert with provinces and territories to provide
consistent advice and timely information to stakeholders and the public. I
believe our accomplishments in this area put our country on solid ground for the
I look forward to hearing this committee's findings on these efforts so that
we can incorporate them into our ongoing planning.
The Chair: Thank you very much.
At the end of the day, 45 per cent of the population was immunized. The
biggest reason for people to not be inoculated was that they did not think it
was necessary. We also heard from people who said that they thought it was
rather late. I appreciate that went to a lot of work to get it out; but this
made the headlines, it was front page news in the early part of the fall, and
yet it was not until December 15 that everything was available. I realize it
rolled out over a period of time, but you ordered this in August and the final
part did not come until December 15. There is a feeling that much of it came
late, and that could have been a factor in why people did not go for it.
I would like you to comment on that and what you think could be done next
I also want you to comment on the gap between when you order it and when it
comes. Regardless of when it comes, there is a gap. What will you do and what
should we be doing in future with respect to that period of time from when you
order it, because I understand from the comments you have made that you have to
determine the actual strain; you have to identify and test it; you want to
ensure that there is no compromise of safety. I understand that, but there are
people who could be suffering in that period of time. What should our plan be to
deal with that gap period?
Dr. Spika: The production of influenza vaccine is a very complicated
process. We knew that from the time the vaccine manufacturer received the seed
strain, it would take 20 weeks for us to start receiving vaccine deliveries.
Indeed, as Dr. Griffiths can comment, we met that timeline.
In terms of the lateness of supply, many issues are related to technology and
the egg-based technology has factors associated with it that delay the
development of the vaccine. Certainly, there is cell-culture technology that
might be able to reduce by four weeks the availability of that vaccine. Even
newer methods are coming along using DNA technologies that could reduce the time
One of the issues before us is to be in a position to encourage companies to
licence those vaccine products when they are available for us to take advantage
of and get used to them, unlike the experience we had with H1N1 vaccine where
the adjuvanted vaccine was new for us.
The gap of 45 per cent was a very good job. Only Sweden did better at 70 per
cent. Most other countries were down in the 10 per cent to 20 per cent range. In
part, lateness was an issue. Another factor that we do not appreciate was that
while public health officials at both the provincial, territorial and federal
levels were trying to coordinate, develop and use common messaging, there was a
great deal of other messaging happening at the same time. This was the first
pandemic to occur during the new information age. In 1918, they had newspapers;
in 1957, they had the radio; and by 1966, they had the television. We had the
Internet, cell phones and all the other forms of social media. If nothing else,
we learned that communication was incredibly complex. The other important thing
is that we did not know a lot about what was going on with the pandemic. We did
not have firm data as to the burden of the disease. As an example, in early
November when we began our immunization campaign, the WHO was collecting
information from a number of countries on the mortality burden associated with
the virus. In their reports, there was a 70-fold difference in the rates of
death between the lowest and the highest country. Most of the countries with the
highest rate of death had the disease during their winter in the southern
hemisphere. Canada's rate of mortality was about one fifth that of Mexico, and
the United States was about one fifth that of Argentina, which, after the first
wave, had the highest rate of mortality.
The Chair: Dr. Spika, my question on the gap deals with the period of
time between the ordering of the vaccine and its availability. What kind of plan
do we need for that period of time?
Dr. Spika: The plan was to use antivirals and to promote public health
measures, such as telling people how to cough, and to wash their hands
The Chair: That should be the plan going forward.
Dr. Spika: That is right.
Mr. Griffiths: Following on that, pandemics essentially come in three
waves. We never know whether it will be number one, two or three. The first wave
is the beginning of the pandemic and there are no vaccines. The only thing you
can do is promote public health measures and antivirals, as Dr. Spika said. The
aim is to have a vaccine by the second wave, if possible. In Canada, that
arrived in late October and early November. At times, there is a third wave,
which we did not see in this case. It is not predictable. Each of these strains
behaves differently, and this particular strain was a more unusual beast than we
had seen before. It was difficult to predict what would happen with this
particular strain. That is the main thing about the gap.
You mentioned earlier the cell-based vaccines. All these new technologies are
being evaluated and will be looked at unquestionably. You will always have that
time gap between the first wave of the pandemic and the second wave. If you can
get there more quickly, it might be useful. Yes, people are looking into these
Senator Champagne: I would like some clarification as the result of a
question addressed to your predecessors, both for us and for the people
Mr. Ring was telling me that the shelf life of the vaccine was 18 months.
Yet, one day in Quebec, I saw people who had stood in line for many hours being
told that, unfortunately, the vaccines could not be administered because they
were no longer good.
I think an explanation would be useful since we are really being given two
Dr. Spika: It is a good question with several aspects to it because
the vaccine that we used required reconstitution. The adjuvant and the virus had
to be mixed together before using them. The short shelf life you describe is
really the shelf life of that mixture because it did not have a preservative in
it. It could only be used within a certain period of time before having to throw
the vial away.
Senator Champagne: The size of the vial made a difference and whether
it was too big or health professionals could not use it in the same day.
Dr. Spika: Exactly. It was a 10-dose vial that came in boxes of 50
vials. Each mix was a 10-dose vial. If you did not administer all 10 doses in 24
hours, the rest was thrown away. Some large vaccination centres were mixing
multiple syringes to take care of the crowds to be vaccinated. It was not as
though you were just using one vial and throwing it away and then mixing
another. Given the timing, it was possible for them to run out of vaccine due to
the length of time it had been mixed.
Senator Champagne: The situation is clear, thank you. I would also
like to talk about the antivirals that proved to be extremely effective. We were
told they should be taken within 48 hours of being in contact with the H1N1
virus. How can seasonal flu or H1N1 be diagnosed within 48 hours? Is it easy for
our doctors to make a diagnosis in time?
Dr. Spika: When H1N1 was circulating, it was the only flu strain
circulating. There was no need to differentiate it from other flu strains. It
was the predominant respiratory virus in circulation. For someone at high risk,
there was a lot of justification and encouragement from us to be vaccinated. For
example pregnant women, morbidly obese people and other high risk people were
encouraged to do the diagnostic test and start treatment.
As Dr. Butler-Jones pointed out last week, we learned a lot. The traditional
recommendation for use of antivirals is you need to give them within 48 hours of
the onset of illness. However, we learned that you could actually go longer than
that. Indeed, for someone that was sick, we could use the antivirals for three,
four or five days after the onset of illness. We were not confined to the 48
hours because that was based on seasonal flu.
Senator Champagne: When we got the H1N1 vaccine, it was very difficult
to get the seasonal flu shot. Going back to a clinic was extremely difficult.
I had a tracheotomy, so I am one of the people with respiratory problems.
When I had to go abroad in July, I was asked whether I got the seasonal flu shot
and I said: "I got it. How long is it good for?"
Do I need another one now?
Dr. Spika: In terms of your personal question, we recommend that you
get another seasonal flu vaccine this year.
Senator Champagne: Even if I had it in July?
Dr. Spika: Yes.
The Chair: We are getting free medical advice here at the committee.
Senator Champagne: Health Canada gave it to me.
Mr. Griffiths: The reason for the need for another flu shot is that
the strains are changing. The shot you had last year will cover a certain number
of strains. This coming season it will be different strains, so they do not give
you protection against the new strains. That is why you have to keep on
Senator Eaton: I would like to applaud you all. Indeed, you did
achieve something wonderful in getting this vaccine, but I think you were so
efficient that I am not sure how many Canadians believe there was a pandemic. Is
there a definition for what a pandemic is, and why was H1N1 considered a
Dr. Spika: There is a definition of a pandemic. The WHO changed their
definition a little bit and their new one was available in the spring of 2009. A
pandemic is a new flu virus strain, unique, that demonstrates the ability to
effectively be transmitted from person to person. Then, as you go up in the
level four, five and six, it is how widely distributed it is globally. Once it
had spread within the Americas region, we were at level five; and once it spread
well within two WHO regions, we moved up to level six.
Senator Eaton: I had my shot. I believed, I listened to the ads and
rightly so. Do you not believe that many people were very wary because more
people were not sick or dying? They were saying what are they talking about, why
am I sitting in this centre for hours. Do you feel there was a disconnect
between what Canadians believed and what you were telling them?
Dr. Spika: There perhaps were some misperceptions about a pandemic
generally. Flu is a virus that is very effectively, once it reaches a certain
stage, transmitted from person to person, but it does not kill everyone. It is
not like an Ebola virus. Many people do get flu that are not very sick or have
mild illness, even with a pandemic.
Senator Eaton: We have winter; we have the flu shot.
Dr. Barbara Law, Chief Vaccine Safety, Centre for Immunization and
Respiratory Infectious Diseases, Public Health Agency of Canada: Another
thing that makes it different from the seasonal flu is the age spectrum and the
severity of disease in the different ages. If you were to ask our intensive care
doctors across the country if there was a pandemic, they would have no problem
saying there was.
There were more young people admitted to hospital, more people needing
intensive care and long use of ventilators to the point that in the first wave
in Manitoba, there was a huge concern they would run out of ventilators for
people who needed them. These were young people, many of them otherwise healthy
or with some underlying condition and that made it very different. Normally in
pandemics, because it is a new virus, people do not have experience with it so
you see it in a younger, otherwise healthy adult population and children.
Senator Eaton: Next time would you communicate things differently? I
guess people were relating to the flu in the early 20th century when hundreds of
thousands of people died so they could not quite make that leap. Perhaps we
should think of teaching Canadians what the word "pandemic" means so they take
Mr. Griffiths: To add to that, there is a perception it was a mild
disease going around. Dr. Law's point was that the younger population was very
susceptible and they went into intensive care.
The problem there is the burden on the health system. Running the ventilators
is very expensive. I am sure you have cases where hospitals were overburdened by
people on ventilators and such. Back in 1918, there were no ventilators, of
course; the whole care system has changed since that time.
Senator Cordy: Thank you for coming before us. It is important that
you share what you have. It is extremely important that we look at the lessons
learned because I assume you are preparing for the next pandemic.
Do you continue to work with the global network of influenza vaccine
regulators? Does working with that group allow vaccines and other
pharmaceuticals to receive approval or disapproval more expediently? I think
that the way that you were able to make approvals while ensuring the safety of
the vaccine was certainly to your credit.
Is planning for pandemics moving to the global scale?
Ms. Ballantyne: As Dr. Spika and Dr. Griffiths have said, the pandemic
vaccine is a hugely complicated process. As Dr. Griffiths noted, there is wave
one and you will not have anything for that first wave because the strain is
just being identified. First, the strain has to be identified by the World
Health Organization and the viruses have to be developed by WHO-certified labs.
Then the viruses are sent to manufacturers and manufacturers start producing the
vaccine. The regulator, which is our group, is basically working in lockstep
with them — the rolling submission as the data becomes available.
No matter how much we plan — and we are doing as much as we can in advance —
there will always be that time from when it starts coming off the production
line and before it can be used; we can only get that data then with that strain.
When you look at what goes into the process, when we say we look at safety,
quality and efficacy, we basically look at the chemistry and manufacturing, the
production line. We look at animal studies and we look at human studies. We ask
the whether that particular vaccine from that particular plant gone into humans
and if it has, what has been the assessment?
We can only start doing those things in that short period. However, as Dr.
Griffiths pointed out, in the pandemic planning, we had a mock vaccine, H5N1,
and we did a lot of work in terms of inspecting the facilities, having the
adjuvant ready and testing it — which would be no matter which strain came in,
the adjuvant would be used. We had clinical trial data on the adjuvant, so we
worked very closely with the global community.
You are right senator; this has become a huge global preparatory. Health
Canada or Canada could not do this alone.
We are working with all of the other counterparts to do the scientific
research to shorten the gap and ensure we are even better prepared.
Senator Cordy: When you speak with the global partners, do you
continue to follow up on the long-term effects the vaccine might have had?
Ms. Ballantyne: Yes, the Public Health Agency monitors the adverse
reactions to the vaccines in the long term, and we do the antivirals in Health
Canada. We work with the global community and all countries involved monitor
those effects as well. All of that information will become part of the data
package for the next time around when we get this information.
Dr. Law: I would like to echo, from a question of safety, there was
unprecedented communication across the country. We had weekly calls from our
counterparts in all the provinces and territories. All parties involved in the
immunization program, federal, provincial, and territorial, shared information
about vaccine safety. We heard about what they were seeing, and heard about
their concerns. We shared with them the global information that was coming to us
weekly from China, Australia, the United States, Sweden and the United Kingdom.
WHO took a big lead in that, and it is a proof of concept of how nations can
work together to study the long-term effects or potential risks of safety. One
concern was a form of paralysis called Guillain-Barré syndrome, which was seen
with the swine flu back in 1967. It did not emerge this time, to the best of our
knowledge, but it is better to be able to test the hypothesis and see if there
was a link.
Canada and the United States will participate in a global study led by the
World Health Organization. The study gathers minimal information looking at all
cases that have occurred over a certain time period from the time campaigns
started to three months after they were finished and looking to see if they
received a vaccine or not in the six weeks before.
This method allows you to prove the hypothesis that there is no link. I think
it is exciting and we hope to build on this information in the global arena.
Especially with rare events, we have to work together.
Dr. Griffiths: In response to your question about preparedness,
whether the regulators group is working, it is working hard here and we are
There is the idea of stockpiling vaccines. There could be domestic or
international stockpiles. The problem is we do not have a crystal ball to say
what might come up, but the likely one would have been H5N1. That is a very
nasty virulent organism moving around in Southeast Asia and Egypt. If that
became highly transmissible, that would be problematic.
Getting stockpiles of vaccine, like H5N1 vaccine, is a possibility and
something we are looking at, how do you monitor those and the like.
Senator Callbeck: Following on talking about the regulators, I take
from what you say, Dr. Griffiths, that before this there was not much global
cooperation among regulators?
Dr. Griffiths: Not at that level, I do not think, no, for this
particular problem of a pandemic. How did we do it? Everyone got together. There
has always been under the World Health Organization a group of people interested
in influenza but not so much the regulators. They were the people who were going
to make the vaccines.
Senator Callbeck: As we go on, you anticipate now that there will be
great global cooperation.
Dr. Griffiths: Yes.
Senator Callbeck: That is good.
Dr. Spika, you mentioned that Canadians had access sooner at greater volumes
and at lower cost and you could provide more information.
Dr. Spika: Yes, I can give some quick updates. We started our vaccine
program here in Canada at week 43 of 2009. The first country that started their
vaccine program was China in week 39. We were one the first eight countries to
get going. There were other countries that started our same week, but to me that
is a demonstration of the fact that we were moving along quite quickly vis-à-vis
Another point is we had all our vaccine delivered by around December 20. Only
one other country was able to do that as far as we know, and that was Australia.
Our vaccines were available quickly and 45 per cent of the population received
it; which is the second highest rate of coverage. Those are key points.
In terms of the pricing, I guess that is something we would have to work with
Public Works on in terms of what they could release.
Senator Callbeck: You have heard the panel from Public Works, and the
question was asked about the 50 million doses. Who made the decision to order
that number? Then we were told it was cut back. Who made the decision to cut it
Dr. Spika: Briefly, realizing we have limited amount of time, the
common understanding with pandemics is that you could need up to two doses per
person to develop the desired immunity. Based on that, basically the provincial
and territorial chief medical officers of health as well as the Public Health
Agency decided that our target, what we felt was required, was 75 per cent
coverage — that is what we felt comfortable shooting for — and that we would
need two doses. That is the origin of the 50.4 million doses.
Now come the fall, as you heard, about the time we were starting our
campaign, it was recognized that we needed one dose in general. In effect, of
the 50.4 million doses, one half you could say was vaccine we did not need but
was part of our good planning process because we were basing our decisions on
the best available information.
Senator Merchant: The government had planned on 75 per cent coverage,
and we said that overall there was something around 45 per cent. Do you ever lie
awake at night and wonder if you could have delivered 75 per cent coverage? We
heard that the system was very strained. If you had to deliver all these
vaccines, if there was a big demand for them and for a second inoculation, what
have you learned from what happened. Can we possibly deliver on 75 per cent?
Dr. Spika: We consulted with the provinces and territories on several
occasions to get their sense of what they could deliver. Indeed, they were part
of the decision making process. There is a session in the next couple of weeks
involving the provinces and territories in terms of planning. Maybe that
question would be best answered at that table because they are the ones
delivering the vaccine.
Senator Merchant: What happens to the unused vaccine or antivirals?
Dr. Spika: In terms of the vaccine, it is a complicated response. The
adjuvanted vaccine had some shelf life issues. That vaccine where the virus lost
its potency, we are still storing the adjuvant from those doses with the intent
of hopefully being able to use them, and that adjuvant represents about seven
eighths of the cost of the vaccine.
Antivirals have a shelf life. Next year, a large chunk of antivirals will be
expiring. We have an FPT process in place to review our overall antiviral
strategy, such as whether we really needed that number of antivirals, given the
fact that there were antivirals available commercially, the numbers we used, all
those factors. Next fiscal year, we will be making some recommendations to move
forward on how best to structure that antiviral stockpile.
Senator Seidman: Canadians had access to H1N1 vaccine sooner, in
greater volume and at lower cost than almost any other country. Dr. Spika, I
think you started to comment on the sooner part, but I am not sure you commented
on the greater volume and at lower cost than almost any other country.
Dr. Spika: To me, the sooner part was in terms of our timing and the
rollout of our campaign. Some countries beat us to it, like China, but the
amount of vaccine they had was minimal compared to their population.
Even though the United States started sooner than we did, they had the nasal
vaccine, which was not good for pregnant women and the very young. They also had
limited supply. They started faster, but we had twice the coverage rate.
Some countries like Sweden, Belgium and Italy started the week before us.
Clearly, Sweden had a higher coverage at 70 per cent, but in terms of the
message about faster, we had all of the vaccine that we planned to use delivered
by December 20.
Other than Australia, which is in the southern hemisphere and was not running
on the same timeline, we were the only other country to get the vaccine out that
fast. For price, I would have to refer to Public Works.
Senator Seidman: You said that you published sequencing guidelines for
vaccine delivery. I would like to know if you have identified any problems in
the sequencing guidelines that you might update for the next pandemic.
Dr. Spika: In a quick response, the development of those sequencing
guidelines was a collaborative effort with the provinces, territories and
ourselves. It identified the highest risk groups for receipt of vaccine. In
terms of how they were actually implemented, there was in some cases a
provincial modification of those, so to speak, as was mentioned in the first
session. One of the jurisdictions decided to put school children up front as
One of the issues that came forward was that some jurisdictions decided they
would not turn anyone away if they showed up. I think the lesson learned was
that by doing so, they saw a lot of queue jumping, long lines and even more
disgruntled vaccine recipients. If there was a clear message that we should
stick with our plan.
Senator Seidman: Ms. Ballantyne, you say on the last page of your
Our experience throughout last year's outbreak also provides us with an
opportunity to improve our actions for the future. We continue to update our
plans and flag areas for improvement, particularly in the way we communicate
our decisions and actions in emergency situations when the need for
information is at its highest.
Could you briefly touch on that? What have you discovered that you could do
to improve your communications?
Ms. Ballantyne: We had heard about authorizing this vaccine earlier,
sooner, and people did not have a good understanding of the steps that we had to
take to ensure we were not cutting corners on safety and working the rolling
submission with the manufacturer of the product as it came off the production
line. It was critical for us to explain the role of the regulator. Where does
the regulator fit in? You have the supplier on one side, the manufacturer, and
you have the public health agency in the provinces and territories making
decisions on how this will be rolled out and when. We do not look at that as a
We wanted to ensure that whatever is rolled out is safe, with the benefits
outweighing the risks. At that point, there was a lot of pressure in the media,
as you had mentioned, in terms of what is taking so long and reports of the
regulator not moving fast enough. We felt we needed to take the necessary time
so that we could ensure that when it was rolled out, we did not have to retract
because of some huge safety issue.
We had to explain that to a variety of audiences so they understood clearly
that we could not cut out any steps, and if we did, there might be unhappy
The Chair: On that note, we have come to the end of this panel. We
appreciate you all being here. We have learned a lot from your presentations in
terms of what you did, the various hoops and barriers you had to work around to
get everything moving. I think while we asked some probing questions, we are
appreciative of the work you have done.
The Chair: We will hear now from the pharmaceutical industry. From
Roche Canada, we will hear from Jim Hall, Vice-President, Urgent Care; and
Anne-Marie Hayes, Business Manager, Government, Urgent Care. From the Canadian
Pharmacists Association, we will hear form Jeff Poston, Executive Director; and
Janet Cooper, Senior Director, Membership and Professional Affairs. From
GlaxoSmithKline Canada, we will hear from Paul Lucas, President and CEO. From Rx
Canada, we will hear from Wendy Nelson, President and CEO; and Jeff Aramini,
Senior Consulting Epidemiologist. Welcome.
Previously in the meeting we heard from officials at Public Works and
Government Services Canada, Health Canada and the Public Health Agency of
Canada. We will now hear your perspectives on vaccines.
Jim Hall, Vice-President, Urgent Care, Roche Canada: I am
Vice-President of Sales and Marketing at Roche Canada. I thank you for the
invitation to address the committee this evening.
As we emerge from the first global pandemic of the 21st century, it is
important to examine and evaluate the outcomes of our country's response. To
that end, I commend the committee for undertaking these hearings, and I am
hopeful that Roche Canada's first-hand perspective and knowledge will assist the
committee in its deliberations.
As the manufacturer of Tamiflu, an antiviral used for the treatment and
prevention of influenza, Roche Canada has significant experience working with
governments around the world on their pandemic plans. We continue to invest
significantly in clinical trial research and other scientific studies related to
pandemics, including work done in Canada led by Canadian experts.
During any pandemic, there will be a lag time of approximately six months
between the emergence and identification of the new influenza strain and the
availability of a vaccine, making antivirals the first line of defence.
However, antivirals are not limited to the pre-vaccine period. Antivirals
augment a vaccine strategy by offering protection during the time it takes to
fully vaccinate a population, during the period of antibody development, and in
those individuals for whom vaccine is not an option. Given our recent experience
where vaccination rates were as low as 40 per cent in some areas, antivirals are
an important treatment option.
Tamiflu's efficacy during the pandemic is well documented both scientifically
and anecdotally. Between May and December 2009, over 21 million treatment doses
of Tamiflu were prescribed globally, including almost 500,000 in Canada, with no
observable new safety signals. We know that treating with Tamiflu resulted in
reduced severity of illness, decreased hospitalization, decreased ICU admission
and reduced mortality. We heard Dr. Butler-Jones tell this committee last week
that antivirals transformed the face of treatment during the pandemic.
As an organization that understands the potential public health threat posed
by an influenza pandemic, Roche Canada works with the World Health Organization
and governments around the world to ensure a supply of Tamiflu. While we do this
in several ways, I would like to draw your attention to our policy of giving
governments and hospitals priority over stock once the WHO declares a pandemic
to be at phase four or higher.
When phase four was declared in April 2009, Roche Canada suspended commercial
and retail sales in order to prioritize governments and hospitals. We reached
out to our government partners and gave them first right of refusal on all
Tamiflu available in Canada. Once those needs were addressed, we worked to
ensure additional supply, as necessary, through our global supply chain.
Roche Canada is proud to say that at no time during the pandemic did we run
out of Tamiflu. While there was a limited supply of the Tamiflu formulation
commonly used for children during the second wave, it was remedied by converting
adult capsules into a pediatric solution. From the outset of the pandemic, Roche
Canada regularly communicated with governments, in particular about alternatives
to providing dosing for children given their heightened risk. We did this by
working closely with the Public Health Agency of Canada and many stakeholders,
including the Canadian Pharmacists Association, to ensure that up-to-date
product information was available at all times.
On the scientific side, Roche Canada continues to conduct clinical trials to
satisfy unmet medical needs for the benefit of patients worldwide. For example,
of the WHO's 14 priority antiviral research areas, Roche Canada is conducting
trials to address more than one-half of them, including studies of critically
ill patients, alternative delivery mechanisms, and pregnant women. Furthermore,
four of Roche Canada's 43 Tamiflu studies are being led in Canada by Canadian
While resistance was not a significant issue with pandemic H1N1, Roche Canada
takes the matter seriously. Dr. Butler-Jones referred to the problem we would
have had if pandemic H1N1 had been resistant to antivirals. Roche Canada
recognizes the importance of remaining vigilant and, to this end, is sponsoring
an international resistance study designed to assess the clinical impact of
naturally occurring and drug-induced resistance to antiviral drugs.
Here at home, Roche Canada is working with the Public Health Agency of Canada
as they review and evaluate Canada's response to last year's influenza outbreak.
We are sharing data, commissioning economic and life impact modelling studies,
and working to understand government's needs in this post-pandemic era.
In terms of validating what worked, it is clear that where there was
pre-positioning of the antiviral stockpile, health outcomes were significantly
and positively impacted.
As for recommendations, I will leave you with two. First, our experience
during pandemic H1N1 illustrated that early and on-going communication between
Roche Canada and the Government of Canada is vital to a successful response. It
was very good, but there is always room for improvement.
Second is the importance of planning, which we cannot emphasize enough. It is
not enough to talk about it because pandemic planning needs to be resourced
properly. In 2006, the government announced a five-year, $1-billion fund to
ensure that the antiviral stockpile and emergency response infrastructure were
capable of dealing with any outbreak. Not only did this funding meet that goal,
it helped position Canada as a world leader in pandemic planning. As the
pandemic preparedness budget is slated to sunset at the end of March, we urge
the Senate to recommend its renewal.
Once again, I commend the work of this committee and hope that you hear from
a wide range of interested parties. We look forward to the committee's report.
Roche Canada is extremely proud of our work during the recent pandemic and of
the pivotal role that our product played in treating and protecting the health
Thank you and I am happy to answer questions.
Jeff Poston, Executive Director, Canadian Pharmacists Association:
Honourable senators, thank you for the invitation to appear before you this
evening. For those of you not familiar with the Canadian Pharmacists
Association, we are the national voluntary organization that represents Canadian
pharmacists. Pharmacists played a pivotal role in the response to the H1N1
pandemic. My remarks today are intended to do two things: to use the H1N1
experience as an example to highlight the role that pharmacists can play in a
pandemic response, and to share with you the things that we learned that can
help us to respond to future pandemics. I believe that pharmacists can be better
utilized in future pandemic responses.
With respect to the role of pharmacists during this pandemic period, for most
Canadians, pharmacists are the most accessible front line health care provider
they can access. They are located in communities throughout Canada; they are
highly trusted and highly valued by their patients. This was proven again during
the H1N1 crisis in Canada, where pharmacists were often the first point of
contact with the health care system.
One of the things we learned is that the communication between the patient
and the health care provider is key. The 2010 Canadian Community Health Survey
asked people who had not received a vaccine why they had not done so, and 74 per
cent of those surveyed said they thought it was not necessary. Clearly, the
communication factor is an important part of managing a pandemic. We also
believe that pharmacists have a key role in improving communications.
Pharmacists provided information about the H1N1 outbreak to Canadians,
answered questions and managed patients who presented symptoms. In that respect,
pharmacists relieved a lot of the pressure from the primary care system by
preventing unnecessary visits to physicians' offices or emergency rooms.
Pharmacists were also responsible for dispensing antivirals from the national
stockpile, and in some provinces were able to extend refills of a prescribed
drug without a physician's authorization, again improving access for the
In some provinces, pharmacists were authorized to prescribe medications and
vaccinate patients. British Columbia extended immunization authority to some 400
pharmacists to vaccinate residents of that province. Nearly 8,000 British
Columbians received vaccination from pharmacists during the pandemic.
I should also add that during the pandemic period our association acted as a
conduit of information between various public health authorities and notably the
Public Health Agency of Canada and front line pharmacists. Janet Cooper, who is
with me today, led those efforts on our behalf. I also want to take this
opportunity to acknowledge the effective work with did we Roche and Health
Canada on access to an oral form of Tamiflu especially for children.
What are some of the lessons learned? Overall, we feel that the response to
the H1N1 pandemic was well coordinated. However, we believe that communications
between public health agencies and health care providers could have been
improved. There were areas where the response was lacking and where pharmacists
could have been better utilized to respond more effectively.
We recommend the following measures should be considered. We found that there
were limited pan-Canadian clinical guidelines provided for community pharmacy
practice and perhaps for other front line providers as well. Clinical guidelines
developed explicitly for community pharmacists and other front line providers
would be a useful tool to support pharmacists as to how best to deal with
potential and real pandemic cases.
There is also little information available to staffing pharmacies on options
around protection measures. Measures that are acceptable in a hospital setting,
such as provision of gowns and masks, do not necessarily apply in community
Our third recommendation is that the distribution of antivirals and vaccines
should use the well-established existing supply chains. The current
manufacturer-wholesaler-pharmacy supply chain in pharmacy already works well and
is effective. We believe that those same supply chains could be used very
effectively during a pandemic period.
We believe that the role of pharmacists should be expanded. Given the
accessibility that pharmacists represent, greater responsibility should be
extended to pharmacists during any pandemic period. Those responsibilities
should include prescribing antivirals or other preventive measures when
appropriate, and the fact that only 45 per cent of Canadians received
vaccinations could have been improved, we believe, if pharmacists were provided
with a greater scope of responsibilities.
Another recommendation is that although we felt that information provision
was good, there were many competing sources of information that we had to deal
with. As an association, we have to sift through and evaluate the most relevant
pieces of information for our members and a more coordinated approach to
information provision would be useful.
Like other health care providers, pharmacists were often poorly informed
about the supply of antivirals and priority vaccination lists. There needs to be
a consistent pan-Canadian strategy put in place regarding supply of antivirals.
In conclusion, as the H1N1 pandemic demonstrated, pharmacists can play a key
role in pandemic responses. However, there are a number of steps that we believe
public health officials can and should take to make better use of pharmacists as
front-line health care providers. We encourage the Senate committee to send a
strong recommendation to the minister and public health agencies to support
expanding the role of pharmacists in future pandemic planning and to ensure that
they receive information in a clear and timely manner so as to maximize the
benefits to their patients.
Paul Lucas, President and CEO, GlaxoSmithKline Canada: Thank you for
the opportunity to appear before this committee this evening.
Learning from the successful Canadian H1N1 response and striving to improve
is a goal we share with this committee, our federal public health officials and
their counterparts across the country.
GSK is the largest biopharmaceutical employer in Canada. We are the only
company in this country with a comprehensive influenza prevention and treatment
portfolio, comprised of antivirals and domestically produced pandemic,
pre-pandemic and seasonal influenza vaccines.
We are a top 15 investor in research and development. We have facilities in
several provinces and employ more than 2,700 people across the country.
GSK supplied enough H1N1 vaccine to protect every Canadian by the end of
2009. I am proud of our contribution, but at the same time, as a significant
partner, feel it is important to offer suggestions on how GSK can contribute to
future success. I believe we can further strengthen our partnerships to ensure
an even more timely, safe and effective response to any future pandemic.
We should note that the 2009 H1N1 response was the largest single vaccination
program in Canadian history. Federal, provincial and territorial governments
rolled out the response in an impressively short time. There were many factors
contributing to this success. I would like to focus on three areas in which GSK
played a critical role.
First, as Canada's only domestic influenza vaccine manufacturer, GSK provided
priority access to a secure supply of the H1N1 vaccine for all Canadians.
Second, Canada selected GSK's innovative adjuvant technology, resulting in
faster access and the potential for broader health protection for Canadians.
Third, strong pandemic preparedness partnerships existed between the governments
of Canada, the various public health agencies, health care providers, and
manufacturers such as GSK and Roche to ensure a coordinated response.
Let me address these success factors in order. First, we were all fortunate
in Canada to be home to world-class vaccine production expertise. Since
acquiring the Sainte-Foy, Quebec facility in 2005, GSK has invested $200 million
in that facility, a timely investment that enabled GSK to provide the entire
supply required for Canada to address the H1N1 threat and handle over 50 million
eggs in the production of the H1N1 vaccine. Let me point out that these 50
million eggs came from Canadian farmers via Canadian transport. A priority
access contract with a domestic manufacturer using domestic raw materials means
a secure source of pandemic vaccine for Canadians.
The World Health Organization declared a pandemic on June 11, 2009, and the
first deliveries of GSK's pandemic vaccine were shipped within four months. As a
result, an impressive 45 per cent of Canadians received protection from the H1N1
virus by being vaccinated with GSK's Arepanrix. By comparison, at the end of
2009, only 20 per cent of Americans, 25 per cent of Australians, 12 per cent of
Japanese and 7 per cent of British citizens had been vaccinated. The U.S. had
five suppliers of H1N1 vaccine; Japan, five suppliers; and most European
countries, two suppliers.
Canada's immunization rate was among the highest in the world. Our government
and public health partners should be congratulated for achieving this notable
outcome. The government also negotiated priority access from their sole
supplier, something other countries with multiple and even domestic suppliers
were not able to replicate.
Second, GSK began planning for pandemic production as far back as the 1990s.
We were able to apply our extensive knowledge, gained from years of research,
innovation, and investment, to the development of a safe and effective H1N1
vaccine. This early investment in influenza vaccine technology of more than £2
billion globally meant that we were able to activate an unprecedented pandemic
GSK's Arepanrix pandemic vaccine contains our innovative adjuvant technology.
Adjuvants are added to vaccines to boost protection against challenging
pathogens like H1N1. Adjuvant technology also uses a lower antigen dose,
resulting in more vaccine to go around.
Adoption of innovative adjuvant technology, combined with a front-of-the-line
contract, put Canada in the best position of any country in the world for a
secure supply of H1N1 vaccine. As a result, Canada had available for use more
vaccine per capita than any other country from any other manufacturer in every
week of the immunization campaign.
Canada was the first country in the world to have enough pandemic influenza
vaccines to immunize the entire population.
GSK made available enough vaccine to protect every Canadian by the end of
2009. That was our commitment, and we met it.
Finally, partnerships across governments, regulatory agencies, public health
bodies and industry are the key to responding quickly and innovatively to an
event as unpredictable as the H1N1 pandemic. With H1N1, we have seen an
unprecedented level of partnership, not just with politicians and officials, but
also with scientific advisers, health care professionals and other
manufacturers, to deliver the right solutions.
While it is important to recognize our collective successes in responding to
H1N1, it is even more important to reflect on the challenges and learn for the
future. As partners in protecting Canadians from future health threats, it is
our responsibility to strengthen our capabilities.
There are three areas in which I believe GSK can make a greater contribution
in the future: first, manufacturing capacity; second, helping to improve
communications between the private and public sectors at all stages of Canada's
emergency preparedness regime; and third, increased attention to supporting
government's efforts to educate the public.
As mentioned, GSK has invested significantly in expanding the capacity of the
Sainte-Foy facility to produce influenza vaccine. In times of urgent global
demand and suddenly heightened public awareness, the vaccine filling process can
become a supply challenge. The H1N1 pandemic reinforced this challenge for all
GSK is exploring ways to expand capacity to handle surge demand. Governments
have a role to play in building this capacity through partnership investments
and utilization of this capacity through expanded demand for domestically
produced annual influenza vaccine. Second, GSK should be more proactively
involved at the planning stage and open to dialogue throughout the process.
As you heard last Thursday, an effective emergency preparedness regime is
essential to a successful response, but emergency preparedness is not a
government responsibility alone. The private sector is a necessary partner in
emergency planning, not simply response. As Mr. Lavoie mentioned, a private
sector panel does advise on pandemic preparedness. We need to expand on this
Each year, GSK in Canada undertakes a complex process to provide the seasonal
influenza vaccine. Our work begins in February. Government and public health
involvement increases in late September with the first shipments of finished
vaccine. Pandemics do not work that way. Governments, public health, Canadians
and the media wanted to take this journey with GSK, step by step.
For future events, GSK is better prepared to open dialogue with our partners
and stakeholders on the complexities and uncertainties across the continuum from
discovery to delivery.
Finally, while Canada had one of the highest H1N1 vaccination rates in the
world, we can and should strive to improve on that uptake in a future event. To
do so, we should collectively help Canadians educate themselves about viruses
The truth is, with the exception of clean, safe drinking water, no treatment
worldwide rivals immunization in reducing mortality rates. According to the
World Health Organization, immunization saves 3 million lives globally each
Unfortunately, during the pandemic there was conflicting information about
the true virulence of H1N1 and about the safety of the vaccine. Additionally,
the public sector was not clear on the benefit of immunization, as you have seen
in the recent Statistics Canada report.
The federal government can lead with a national immunization strategy, one
that builds capacity, prioritizes education and helps dispel such misinformation
we witnessed being circulated last fall. As a responsible partner, GSK can
continue its efforts to create awareness of the importance of immunization not
just during pandemics and the annual influenza season.
GSK is a long-standing partner with governments across Canada and around the
world in delivering life-saving medicines and vaccines. I would like to
acknowledge the challenging and excellent work done by all involved, including
the foresight of the federal government, along with their provincial and
territorial counterparts, to plan for such an event as far back as 2001, and to
secure priority access and domestic supply of vaccine.
Thank you for undertaking this extensive study to ensure we recognize our
successes, learn from our challenges and further strengthen our partnerships so
that together we can effectively and efficiently respond to the needs of
Canadians in the face of a future pandemic.
Wendy Nelson, President and CEO, Rx Canada: Thank you for the
opportunity for Rx Canada to appear before you this evening.
Rx Canada was the lead organization responsible for the National Antiviral
and Over-the-Counter Medication Surveillance Program for the Public Health
Agency of Canada during the recent H1N1 outbreak. Dr. Spika referred to this
The project started in May of 2009: mere days after the outbreak made
headlines. I have with me tonight Dr. Jeff Aramini, who is Senior Public Health
Epidemiologist on the project, and who is President and CEO of Intelligent
Health Solutions, a project partner with Rx Canada.
I would like to spend a few minutes telling you a little bit about Rx Canada
and the role the pharmacy sector can play in pandemic preparedness. Mr. Poston
talked to you about the role of the pharmacist, and I will talk to you about the
role of pharmacy, the operation or business entity of pharmacy. I will also
provide you with a concrete example of the role pharmacies played in the recent
We are here tonight to convince you that this unique pharmacy surveillance
system, established during the H1N1 outbreak, should be recognized as an
essential component of the Public Health Agency of Canada's pandemic
surveillance system and funded on a permanent basis. I believe Dr. Aramini and I
have some compelling evidence to convince you of that within the next five
Sometimes out of a crisis comes a gem, a new project and some innovation, and
that is what this project was all about.
Rx Canada is a pharmacy-sponsored organization committed to enabling
pharmacists with tools, programs and technology to provide excellent patient
care. To this end, Rx Canada has developed a suite of evidence-based programs to
manage chronic disease and improve medication adherence. These programs are
offered to the Canadian public through their pharmacist.
Rx Canada is also committed to working collaboratively with governments to
develop and execute national and provincial pharmacy solutions. Examples of this
include the national drug recall system that we are developing in collaboration
with GS1 Canada, and of course this project which is the focus of my remarks
Rx Canada works with all pharmacies in Canada. Currently we work actively
with over 4,000 Canadian pharmacies, both chain and independent pharmacies. We
receive and track over 70 per cent of all prescriptions dispensed in Canada.
Participating pharmacies use our suite of evidence-based programs and a
technology network that we call Rx Gateway, which links pharmacies to a central
data hub, a near real-time national prescription and OTC database that we use
for service execution, reporting, program evaluation and research. This unique
system was built as a result of investment and cooperation from the pharmacy
industry, and it provides value, especially during times of public health
Rx Canada's data reporting systems and Canadian pharmacies were called to
immediate action during the recent H1N1 crisis. Within one week of being called
upon by the Public Health Agency of Canada, Rx Canada was able to mobilize over
2,500 pharmacies, in all provinces, to supply us with daily prescription data
related to antiviral medications such as Tamiflu and Relenza. We also received
daily over-the-counter medication sales data related to products for the early
treatment of flu symptoms, such as cough and cold medications.
This data represented a statistically significant sample of the national
pharmacies in operation. In rural and remote regions, Rx Canada reached out to
independent pharmacies, putting in place the necessary data collection systems
to ensure representation from as many communities as possible. All data was
"anonymized" and was aggregated to protect the identities of patients as well
as information related to individual pharmacies and pharmacy chains.
This was Canada's first national pharmacy based surveillance system, a system
that is in place in a growing number of public health jurisdictions throughout
the world, including the U.S. and Europe.
As realized in these other jurisdictions, near real-time information on
pharmacy over-the-counter products can help public health officials identify
outbreaks earlier than is possible through laboratory tests ordered by
physicians when patients present with more severe symptoms. An effective
surveillance system using over-the-counter data can detect outbreaks or
significant health trends days or even weeks before lab confirmation.
In the case of the H1N1 outbreak, we detected increases in respiratory
related OTC products — the cough and cold medications — three to six weeks prior
to the second wave of the H1N1 influenza. In the second wave, sales of these
products peaked approximately three weeks prior to a peak in antiviral
prescriptions and began to decline during the vaccination campaign. In outbreak
situations, the public health officials and health care workers can use this
precious time to ensure public safety and an appropriate response.
Based on Rx Canada's national data collection system during the H1N1
outbreak, experienced epidemiologists such as Dr. Aramini applied complex
statistical algorithms to produce some daily, weekly and monthly reports for
public health officials in Canada. Daily reports provided local public health
officials with information to detect new clusters of activity, monitor community
health trends and develop appropriate strategies for outbreak management. Weekly
and monthly reports provided more summary information at provincial and national
I believe senators have a copy of one of the monthly summary reports that we
provided. The reports were jointly developed with the Public Health Agency of
Canada and contained charts, graphs and summary trends, making it easy for
public health officials to monitor, at a glance, occurrences in their province.
Recently, we have created and are evaluating specific health region reports
that drill down to a very local level. We have also proposed to the Public
Health Agency of Canada the development of online reports to immediate access
In addition, during the outbreak, ad hoc reports were produced to monitor
specific activity such as during the Vancouver 2010 Olympic and Paralympic
Winter Games. At one point in the outbreak, Rx Canada's electronic messaging
system in pharmacy was mobilized to disseminate critical information about
antiviral supply — a paediatric oral Tamiflu — to over 10,000 dispensing
pharmacists within 24 hours of notification. This same system can be used to
provide the Canadian public with immediate, standardized information during
outbreaks, as well.
Rx Canada is in the process of creating a quality assurance data set of
historical data that can now be used by the Public Health Agency of Canada for
retrospective analysis and comparative analysis with other data sources to study
what occurred during the H1N1 outbreak. This will give government officials a
look back on what happened in order to learn and plan for improved responses
Overall, our work during H1N1 was well received. The government consulting
services conducting a review and a survey of territorial and provincial
representatives. A full 77 per cent believed in the value of sustaining this
type of system and supported the project. Just as important, 94 per cent of
public health respondents found the reporting system timely, 86 per cent found
it easy to access and 74 per cent found it user-friendly.
The federal government provided approximately $1.5 million toward this system
over the past 18 months. This was more than had been projected when we proposed
the system to the Public Health Agency of Canada back in 2008. However, most of
that investment was required in the early weeks and months to ensure immediate
mobilization of the reporting system and a national pharmacy response in
conjunction with H1N1 activity.
Rx Canada's existing drug data management infrastructure has been used and,
to date, Canadian pharmacies have contributed data to the project on a voluntary
basis. No investment has yet been made in hardware or software, including
automation, to drive down operating costs and ensure efficiency over a longer
period of time.
Most important, this investment has now created a reporting system that is
sustainable and scalable. The reporting system can be readily expanded to
monitor not only flu but other outbreak situations, such as SARS, waterborne
disease such as we experienced in Walkerton or environmentally triggered
outbreaks such as asthma caused by poor air quality.
Such a financial investment has a return over a very short period of time.
Based on a business case we produced for the Public Health Agency of Canada, if
pharmacy surveillance reporting is broadly based, automated and maintained on a
regional basis, this type of national pharmacy based surveillance system should
conservatively save the Canadian public $2.5 million per year in avoided health
service costs due to early detection of outbreaks.
In conclusion, by leveraging its existing technology network and the
prescription pharmacy data system, Rx was able to mobilize support from Canadian
pharmacies to implement and deliver this first-of-a-kind surveillance system. We
maintained it throughout the H1N1 influenza outbreak and we are ready to
continue to report during the next flu season.
This public health surveillance program is a testament to the important
contribution that community pharmacies can make to ensure effective pandemic
preparedness across Canada. Our recommendation to the Public Health Agency of
Canada and to your committee is to keep this innovative system in place and
recognize and resource the system as an ongoing essential component of Canada's
Thank you for your time. Thanks to all the pharmacies that contributed to
this project and to the senior officials in the Public Health Agency of Canada
for their vision in allowing this project to move forward.
The Chair: Mr. Lucas, I want to focus on the vaccine you produced.
Could you tell me about the manufacturing issues you faced in the production of
the vaccine and what needs to be done to resolve any of the issues that arose in
that period of time?
There has been some discussion about packaging and that packaging seemed to
be instrumental in some physicians deciding not to be involved in giving the
vaccine; the quantities were much larger than they felt they could cope with.
Could you discuss packaging?
You mentioned the 50 million eggs. I will not throw an egg at you, but some
people are allergic to eggs. I understand the U.K. did something a little
different in that regard. Maybe you could comment about that part of the problem
Mr. Lucas: Thank you. On the manufacturing situation, this is where
communication between ourselves and the government and so on would have been
more helpful to explain exactly what happens in the manufacturing process.
The unique thing about the H1N1 vaccine was that the virus was kind of
difficult to work with. It was difficult to formulate. Every manufacturer had
that same problem and the WHO recognized that and so on. That was not unique to
us by any means. Keep in mind that no one had made this vaccine before. In any
manufacturing process, in any industry, for any product, you can never make the
product right the first time. It was not unusual that we would run into issues
in terms of production as we were making it for the first time. We did. However,
that was not unusual, as I say, in terms of manufacturing. This was a more
difficult virus to work with.
When we make the seasonal vaccine, we also have problems. No one ever sees
that, though, because we get an order, we produce it, we work out all the bugs
and deliver it in September. No one sees the issues we face in terms of making
it for the first time. For H1N1, we were doing that in real time, so people saw
that and said, "You are having problems with manufacturing." They were not
really unique issues.
When you look at the timelines, we typically make the seasonal vaccine every
year. From the time we get the seed strain to the time we get it out the door,
it is about seven months. In the case of H1N1, we did it in four months — a
vaccine we had never made before. I think we left the committee a chart in terms
of mapping out the manufacturing process.
This product was packaged in what we called "shoe boxes." The vials were 10
doses each and there were 50 vials in each box. That is a global standard. All
of our customers received that package around the world, not only from this
plant but also the other plant. The reason for that is it significantly
accelerated how quickly we could get vaccine out the door.
For those jurisdictions in Canada that employed mass vaccination clinics,
that was not a problem. However, if you were trying to deliver that through
physicians' offices, it became a problem. It was related to the jurisdiction and
how they actually distributed it.
The Chair: That is different from a seasonal flu because that is given
by physicians. You must package that differently.
Mr. Lucas: Yes. We are not in a situation where we are working on a
much tighter time frame. Clearly, the bigger boxes speed up the production
process. You are always making trade-offs in this process. You do something to
slow down or to speed up. In the case of H1N1, everything we did was to speed up
the process. We accelerated our quality control times. We shortened those from
what we normally do, without taking undue risks. We were doing everything we
could to shorten the process and that is why we could do it in four months, not
seven. There was a lot of urgency. Hopefully that explains the packaging issue.
On the egg allergy situation, I am trying to remember that discussion. There
is a very small proportion of the population is allergic to vaccines made from
eggs. I think the U.K. sourced one that was made from cell culture. The problem
is that the vast majority of flu vaccines are made from eggs and cell culture is
not a very advanced technology in this area. You do not have a lot of choice,
but a small proportion of the population is affected.
Mr. Poston: If I could add something on the packaging, I think both
the manufacturers that are at this table did a superb job in responding. One of
the interesting things that happened with packaging was we had hospitals second
pharmacy technicians to clinics in some part of the country because these
vaccines had to be reconstituted. It was another factor that was an issue, so we
had a number of major success stories of nursing and pharmacy partnering to make
this a very smooth transaction at the mass clinic level.
However, the committee has an important point, and it is something to think
about in terms of planning mass preventative measures. The ease of
administration of your product is critical. I think the trade-off Mr. Lucas
described is a classic one. It is ease of administration versus mass coverage
and there is always a trade-off.
It is important for the Public Health Agency of Canada and the work that goes
on in planning responses to pandemics. This is a viral pandemic; it could have
been a bacterial pandemic. Even in emergency preparedness measures, it is
something important to consider as you plan the response.
Mr. Lucas: The only difference in packaging from seasonal vaccine is
the larger number of vials. The vials are the same; they have 10 doses in them.
Senator Martin: Mr. Hall and Mr. Lucas, both of you spoke about
priority access, and it is reassuring to know there is priority access for
Canadians. Is that guaranteed?
Mr. Hall: Our policy is that governments have priority access to
antivirals and that will not change, as far as we can tell. There would be no
reason for it to change. That is our policy and there is good reason for it.
The concern is not about priority access; that is pretty much ensured. It is
making sure you have enough antivirals if a pandemic were to occur. The best way
to ensure that is through stockpiling, and that is what the Canadian government
has decided to do, thankfully. When we had the recent pandemic, there were
enough antivirals to cover all Canadians.
Mr. Lucas: To be clear, that priority access is different than this
priority access. That is priority access to governments around the world.
Canada, through the contract that they have with GSK that expires at the end of
this year, had priority access to the vaccine coming off our line. We could not
ship to anybody else until we supplied Canada.
That is a huge privilege for Canada. For me, it was the fundamental reason
why Canada was able to get as much vaccine as quickly as we did.
In terms of whether it will continue and whether it is guaranteed, that will
be determined in the upcoming procurement process around a new contract. Canada
is fortunate in that it is one of very few, if only, countries in the northern
hemisphere that has priority access. You have to build that into the contract.
Senator Martin: All of you provided very specific recommendations,
which are helpful. The role of the pharmacist is one that I think is another
very key point. Just listening to some of your recommendations, some key themes
include partnership, education and planning. Have you begun the process to
include pharmacists in a greater way for the next pandemic outbreak?
Mr. Poston: One thing that is happening in most of the provinces in
Canada is that there is legislation being passed that is giving pharmacists some
form of prescriptive authority. That is clearing some of the legal obstacles.
As an association, we have worked closely with the Public Health Agency of
Canada to develop and build into this plan. The further development speaks to
the importance of planning.
Ms. Cooper: Perhaps committee members are unaware of the role that
pharmacists played in the pandemic. Patients were coming into pharmacies with
influenza like symptoms and the pharmacists were assessing their symptoms and
providing them with advice and recommendations. The pharmacists were advising
the patients to go home, take an over-the-counter medication, or go to the
emergency department of the local hospital. It was an assessment of their level
of illness. That triaging role that community pharmacists played was a critical
one, especially at that time. During that time, pharmacists gave advice and
recommendations on the patients getting the vaccine.
Often they were the kind of go-to source of information to clarify all the
confusing information out there in the media. Should I get vaccinated? What
about antivirals? We had people wanting to get prescriptions for antivirals,
especially during the first wave, to hoard it themselves. Pharmacists were
seeing a fair number of prescriptions that probably were not appropriate for
antivirals. There was a big role, but as Mr. Poston said, we continue to work
with our pharmacy partners and other health care providers, as well as the PHAC
and Health Canada.
Senator Martin: Thank you for the good work all of you have done.
Senator Ogilvie: Mr. Hall, where is your Tamiflu produced for the
North American market?
Mr. Hall: We have facilities throughout the world. I am not at liberty
to say exactly where our production facilities are. That is commercially
sensitive information, but we have production facilities throughout the world in
many different countries and have many different partners.
Senator Ogilvie: If that is your answer, I find it remarkable, but I
will leave that alone and go to the issue of 500,000 doses, which was the amount
of Tamiflu that you supplied.
Mr. Hall: There were 21 million prescriptions globally and, yes,
500,000 prescriptions were filled in Canada.
Senator Ogilvie: Were these 500,000 prescriptions in addition to the
stockpile that Health Canada refers to that it had in various locations, or is
that the amount that was produced to provide their stockpile?
Mr. Hall: The 500,000 prescriptions likely came largely from the
stockpile that was deployed throughout Canada, and some may have come from
regular retail channels as well.
Senator Ogilvie: Thank you.
Mr. Lucas, you clearly indicated that 100 per cent of the vaccine supplied in
Canada was produced in Canada.
Mr. Lucas: Correct.
Senator Ogilvie: Were you able to supply any export markets from
Canada in addition?
Mr. Lucas: Yes, we were, but only after we supplied and filled
Senator Ogilvie: I understand. Thank you very much.
With regard to the adjuvanted vaccine, we heard from the previous panel that
the adjuvant can be reformulated and reused. Is that done by having it returned
to you and that process is carried out or is that carried out by Health Canada
or some other facility?
Mr. Lucas: With the H1N1 vaccine, there was one vial that had the
adjuvant and one vial that had the antigen, so the antigen is gone. Now there is
the adjuvant, and that sits in a stockpile. If there were an H5N1 vaccine, they
could use that adjuvant with that antigen.
Senator Ogilvie: Thank you very much. If it had been put that way in
the earlier panel, I would not have asked the question.
Ms. Nelson, coming to Rx Canada and the pharmacies in general, I was
delighted to hear the issue of your independent efforts to develop an automated
information system, the value of which is obvious. If you can develop this and
then by some miracle convince the medical profession that it ought to use the
same with regard to prescriptions, we might save 15 per cent of the deaths that
occur immediately from all sources in hospital systems, let alone the issues
that arise from these kinds of issues, so please continue. If there is anything
we can do to help, please let us know.
Ms. Nelson: Thank you. We totally agree and appreciate the support.
Senator Champagne: Mr. Poston, you seem a little disappointed to see
that only 45 per cent of Canadians were vaccinated. You said there had to be
some sort of communication problem. I completely agree with you because,
whenever a radio or television public affairs broadcast had a guest to talk
about the importance or the necessity of being vaccinated, they also had another
guest who was against vaccination, just to seem like they were not taking sides.
In instances like that, if we had another pandemic, God forbid, I think
pharmacists could play an even more significant role, whether they are from your
association or from Rx.
We are obviously asking ourselves whether the distribution system has to go
through you. But pharmacies, instead of selling lottery tickets, should display
big posters showing the importance of being vaccinated. Are you wondering
whether you should get the vaccine? Come and talk to us. I believe that is what
pharmacists should have done and should do, if this happens again.
Mr. Poston: We would support that, and indeed, much of our messaging
to pharmacists was around the need to encourage patients to be vaccinated and
educating patients why it was important to be vaccinated. There is further
potential to do that.
One of the things we dealt with is that accessibility to vaccination varied
as well. Certainly, the experience in British Columbia pointed to the value of
having pharmacists able to administer vaccines. I think that the mass
immunization clinics worked extremely well in some places, but if we were going
to do better than 45 per cent, we have to think about mobilizing family
physicians, community pharmacists, the people that are in day-to-day engagement.
One of the big issues that we focused on was trying to ensure that the
high-risk patients were vaccinated, and this is where the sort of program that
Rx Canada runs could be an example. Pharmacists who are dealing with chronic
asthmatics, the patients with respiratory illness, the need was to ensure that
population got the message that it was important for them to get vaccinated.
They are all good points and there are certainly areas that we encourage
pharmacists to do, and we can build on that in the future.
Senator Champagne: It is obvious that you can do a lot of things
because people go to the pharmacy a lot more often than to the doctor or the
hospital emergency room.
My other question is for Mr. Lucas. A number of people told us they were
concerned about the fact that the government only used one vaccine supplier. I
apologize for this bad pun, but that is what we call "to put all one's eggs in
one basket", and when there are 50 million eggs, that is a lot of eggs.
You said that you felt you were in a really good position. What would happen
if the vaccines had to be recalled for one reason or another? We would be in a
situation where we could no longer get vaccines because they come from one place
only and, if that place had problems, it would become a real issue. It is not
that I want to take business away from you, but I need to be reassured.
Mr. Lucas: That good question has come up a number of times. Canada
has been in a pretty position to have priority access. The question is what
would happen if. The reality is if we could not make the vaccine no one else
could make it either because we have a lot of practice in making vaccines. As
long as we can formulate the specific virus, and H1N1 was a little more
difficult, you saw that we had a little difficulty with the formulation but so
did everyone else.
In the case that you outlined, it is not unreasonable to have some sort of
backup plan. I know that previous presentations have tried to address that
situation, but the question is can you actually get a backup supply. It is a
matter of cost, availability, access, and risk management. If you have a backup
supply that is not manufactured in Canada, will you ever get it anyway? If the
border shuts down and everyone is having a problem making vaccine, Canada will
probably not get that vaccine. You are always managing a risk and the cost and
Senator Champagne: I just wanted to hear it from the horse's mouth.
Senator Cordy: You have been most helpful with your comments today.
Mr. Lucas, I know that you were not the one who said that it should be 50.4
million doses. That was a government decision. Witnesses that we heard earlier
said that number changed as time moved on. What was the final number? How many
doses did we end up buying?
Mr. Lucas: I will not be able to answer that specific question.
The number moved around a lot. The 50.4 million doses, I thought, was a
sensible approach. Since that time, there have been a couple of adjustments so
we forgave the government some doses. We cancelled part of the agreement. We
have given credits for some of the vaccine antigen because of the shelf life
It is hard to give you a specific number as to how much antigen and adjuvant
we actually sold. I would have to go back and calculate that number. It was
significantly less than 50.4 million.
Senator Cordy: I think all of you touched on communication. I think
Mr. Lucas's private-public sector silos have to be minimized. I believe Mr.
Poston spoke about conflicting messages and about receiving information in a
clear and timely manner.
This is not the first time we heard that communication was a concern during
the pandemic, as in the question that Senator Champagne just asked. People were
reading an advertisement from the federal government on one page of the
newspaper and there was conflicting information on the page facing it; people
just did not know whether they should get the vaccination.
How will we overcome that problem? What can we do better the next time in
terms of communication? We saw Dr. Butler-Jones on television, if not every
night, every second night.
Mr. Poston, you talked about the role of pharmacists. I trust my pharmacist
in Cole Harbour. I can talk to him and he is extremely helpful. When our
committee did a study a few years ago on the health care system, we recommended
that pharmacists play an even bigger role in the partnerships of caring for the
patient. That is starting to happen although it has taken a while.
Mr. Poston: We had information to deal with from the Public Health
Agency of Canada, from the World Health Organization, provincial governments and
regional health authorities. If you think about it, your pharmacist in Coal
Harbour was getting messages from the WHO, the Public Health Agency of Canada,
the Nova Scotia government and regional health authorities. We would be saying
something and the media would as well. There was this vast number of sources of
It was very good that we had Dr. Butler-Jones out front on the media. I think
one of the critical things is a strong role for the Public Health Agency of
Canada. There probably needs to be more funding and support around the
communications piece and the link with the media.
Also, they did a fairly good job of coordinating us as organizations that
were involved. I think at one stage there were daily teleconferences, but it was
just managing all of these different pieces of information.
I would start with looking at the role of the Public Health Agency of Canada,
but to pick up on Mr. Lucas's point, they have to bring the private sector into
it. Ms. Nelson's company is a good example of where the private sector made an
important contribution to assisting public health in this area and it all has to
be brought together.
Ms. Nelson: There are wonderful pharmacists who we trust and go to for
health advice, but even the best pharmacist's need tools. We are able to supply
the pharmacists with communication tools. I will go back to the example that I
made in my remarks.
The Public Health Agency of Canada had a key message to get out on the supply
of antivirals. Within 24 hours, they had approved the message they wanted to go
out through pharmacies. Through our technology, we were able to get that message
out to 2,500 pharmacies and all of the dispensing pharmacists who work in those
We need to take advantage of those types of systems and work collaboratively
on the message that needs to get out, and then engage pharmacists to get that
message out to the community.
Mr. Lucas: It is a big challenge and it has to be multi-factorial. I
thought Dr. Butler-Jones delivered some strong consistent messaging. The press
loves to talk to the contrarians that that created many of the problems. I will
be critical of the press on that front. "Canada AM" and all the big networks
went to the people who contradicted what was coming out of the Public Health
Agency of Canada. That created a lot of problems and I do not know how to fix
that in a democracy.
Senator Cordy: Mr. Poston, what did you mean when you said we should
be using the supply chains that we currently have during a pandemic?
Mr. Poston: In some provinces, it was a question of how do you
distribute the national stockpile, particularly of antivirals? In some
provinces, rather than saying you can get your antivirals through the local
pharmacy, there was a debate as to whether you had destination pharmacies so you
picked special pharmacies to send it to. There was a lot of debate and
discussion around distribution.
There is a well-oiled, well-established distribution chain. Most pharmacies
get at least one delivery from their wholesaler every day; some get as many as
three deliveries from their wholesalers every day. There is a well-organized,
very efficient and effective supply chain for pharmaceuticals in this country.
There is documentation and monitoring; there is a cold supply chain that ensures
if it has to be kept in a refrigerator, it stays at the right temperature over
that supply chain. Pharmacists document their stocks so if you had to do a
product recall, you could do it easily.
There are many advantages to using the established supply chain. There is no
need to create a separate supply chain when you are dealing with a pandemic or
some emergency situation.
Ms. Nelson: From a tracking and accountability point of view, it is
easy for us to count and track what comes through that supply chain. It posed
more difficulties for us to track what was happening in the stockpile. Again,
the other advantage of using the existing system is that we can track and trace
whereabouts of the product.
Senator Seidman: Ms. Nelson I am looking at your monthly report.
Figure 1, shows the relationship between the national antiviral prescriptions
and the respiratory related over-the-counter transaction is impressive. It makes
a case showing the value of good data in predicting important trends under very
critical circumstances, so thank you for that.
You say here that no investment has been made in hardware or software to
drive down the operating costs of what must have been a valuable tool for the
Public Health people. You say that you made a recommendation to Public Health in
order to recognize and resource the system as an essential component of Canada's
pandemic surveillance system. Have you had a response from them?
Ms. Nelson: Not actually, but we are optimistic. Our existing contract
ends at the end of November. We are slated to have discussions on what the
system would look like going forward.
We have brought forward proposals to automate the system. It was not
automated during H1N1 because of the nature of our contract with Public Works;
we were not able to buy hardware and software. However, going forward,
automation is a key to processing this information in a timely way and then
driving down the costs. They have our proposals and we are optimistic. Your
encouragement is very much appreciated.
The Chair: That brings us to the end of the meeting. Thank you all for
being here and thank you for the information you provided to us. It will be most
helpful as we move forward and try to give the government a plan that it can
work on in the future if and when we face these circumstances again.