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 products.


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 being sought.

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 pandemic.

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 world.

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 concluded.

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 supplier.

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 antiviral drugs.

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 vaccine.

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 purposes.

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 offshore.

The Chair: You have no possibility of a backup supplier in Canada, is that right?

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 delivered.

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 vaccinations.

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 essential.

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 supplier.

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 questions.

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 procurement process.

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 RFPs.

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 vaccine.

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 requirement.

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 August 2009.

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 ordered.

Senator Callbeck: When was it established that one or two doses would be required?

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 about that.

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 centralized systems.

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 enough.

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 outbreak.

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 competitive process.

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 lesson.

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 location.

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 Health Canada?

Mr. Kreker: The decision as to the quantity of vaccine to be ordered was made jointly between the provinces, territories and federal government departments.

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 regulator.


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 these products.

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 international colleagues.

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 domestic level.

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 global activity.

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 immunized.

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 safety.


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 wave.

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 ultimately taken.

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 future.

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 time.

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 line.

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 frequently.

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 gaps.


Senator Champagne: I would like some clarification as the result of a question addressed to your predecessors, both for us and for the people listening.

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 versions.


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 changing.

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 pandemic?

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 it seriously.

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 working together.

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 other countries.

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 back?

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 well.

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 presentation:

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 regulator.

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 consequences.

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 experts.

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 of Canadians.

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 consumer.

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 settings.

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 response.

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 vaccine manufacturers.

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 practice.

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 and vaccinations.

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 year.

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 project.

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 H1N1 outbreak.

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 minutes.

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 today.

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 emergencies.

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 levels.

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 throughout Canada.

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 moving forward.

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 surveillance system.

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 as well.

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 Canada's requirements.

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 so on.

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 issue.

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 information.

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 pharmacies.

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.

(The committee adjourned.)