Health Committee on July 6th, 2020

[Dr. Scott Halperin]

CanSino is not going to be avoiding phase three trials. CanSino is currently, working with the WHO and other country partners, planning phase three studies, which are going to take place in various countries around the world. As with all manufacturers, they will be undertaking phase three studies.

My understanding is that the Chinese government has decided to use that vaccine—and again this is from the news, not from CanSino—in Chinese soldiers under what would be called, in Canada, an emergency authorization. In Canada, we may also use an emergency authorization down the line with one of the vaccines that is successful. What that means is we would be able to use the vaccine on a large scale prior to having full phase three information and full market authorization.

[Tamara Jansen, Conservative, Cloverdale—Langley City, BC]

Is that like throwing out the medical ethics due to the urgency? Is that what we're thinking?

[Dr. Scott Halperin]

No, that's not at all what we're thinking.

What we'd be doing is exactly what was done with Canada's Ebola vaccine, where phase one and two studies were done and then phase three studies and an emergency authorization were used, and that stopped the epidemic in west Africa. In fact, that vaccine, which was ultimately being developed by Merck, only received licensure, full market authorization, about a year and a half ago, four years after it stopped the epidemic in west Africa.

Emergency authorization is one of the tools Health Canada has as well, and may be something that may be used for a promising vaccine, no matter who the manufacturer is. That's done in a perfectly ethical manner.

[The Chair, Liberal, Ron McKinnon]

Thank you, Ms. Jansen.

We go now to Mr. Van Bynen for five minutes.

[Tony Van Bynen, Liberal, Newmarket—Aurora, ON]

Thank you, Mr. Chair, and thank you to the witnesses who are making themselves available for this important research.

My first question is for Dr. Halperin. Around the globe people are hungry for a vaccine to put an end to the COVID-19 pandemic, but we also have an anti-vaccine movement that seems to keep growing, even during a pandemic.

In your professional opinion, could the anti-vaccine movement undermine the efforts to end the COVID-19 pandemic? To people wondering whether or not they should take the vaccine, once ready, what challenges may an anti-vaccine movement pose?

[Dr. Scott Halperin]

The anti-vaccine movement, or anti-vaccine sentiment, is a challenge to any vaccine program, whether it's COVID-19 or any of our routine vaccinations. There's been a lot of effort to understand that movement and to address it.

The anti-vaccine sentiment runs a wide range, from people who are just a bit hesitant because they don't feel there's enough information, to people who are philosophically opposed to a vaccination. The latter tends to be the minority, maybe a couple of per cent, but in terms of vaccine hesitancy, it may be as high as 20% or 30% of people who have some concerns. The important part about addressing vaccine hesitancy is to be as open and as transparent as possible, to provide as much safety information as is possible and to address people's concerns, both at an aggregate level but then also at an individual level.

The Public Health Agency of Canada understands that vaccine hesitancy can be an important factor in the response once we have a COVID-19 vaccine. It's one of its priorities for CIRN, the Canadian Immunization Research Network's social sciences and humanities network, to address and do research on those concerns in preparation for potential vaccine hesitancy as vaccines are rolled out. It is a high priority of our research.

[Tony Van Bynen, Liberal, Newmarket—Aurora, ON]

Could you confirm how large the threat of the anti-vaccine movement is in Canada, what we are currently doing to counteract it and if you're satisfied with that? If not, what else would need to be done?

[Dr. Scott Halperin]

Overwhelmingly in Canada, Canadians are pro-vaccine. The vaccine hesitancy probably accounts for approximately 20% of the population. When we talk about vaccine hesitancy, that doesn't mean 20% of people aren't getting immunized, but they may delay their immunization or want to try an alternative schedule. It runs that whole range across the board from just a little bit hesitant up to absolutely not being immunized. The absolutely not being immunized is only a couple of per cent, to our best understanding.

Improving vaccine coverage has been a high priority of the Public Health Agency of Canada and recent governments. There has been a fair amount of funding that's been given to CIRN to understand and improve vaccine coverage over the past five years. We know a lot more about vaccine hesitancy, and we are developing interventions to address it.

[Tony Van Bynen, Liberal, Newmarket—Aurora, ON]

My next question is to each of the groups represented. How can Canada support more research in biomedicine? Could you elaborate on what we're doing well, what we should improve and what we should be doing to do so? Why don't we start with Innovative Medicines Canada?

[Pamela Fralick]

I hate to sound like a broken record on this particular question, but probably the most important piece that we could do in Canada would be to get that balanced, whole-of-government approach to the two issues of cost containment and the investment attraction programs that are in place.

On the one side we have PMPRB. It plays a good role for Canadians when well implemented, but its current measures are too extreme. When companies are looking at losing up to 70% or 80% of their revenues, they basically don't have anything left to invest. On the other hand, we have some exciting programs out of ISED, with its HBEST, health/biosciences economic strategy table, where it wants to double investment in Canada, double employment levels, etc., by 2025. This is something that gets the companies that are my members very excited.

However, there is an imbalance right now without a whole-of-government approach to balance those two off. The regulatory regime needs to be taken down a notch, so that we can take advantage of investment, and obviously, get all the best medicines to Canadians. It's that, and as I mentioned as well, the time to list, making sure our system is as smooth and as well sequenced as possible.

[Tony Van Bynen, Liberal, Newmarket—Aurora, ON]

Okay.

The CGPA.

[Peter Hardwick]

This was fascinating. I'm voting for IMC to find a vaccine sooner than possible for Canadians. Keep up the great work.

I can speak to Apotex specifically. On the generics side we spend close to $200 million a year on research and development in Canada. A lot of this is in biosimilars. I think for us it's around sustainability and predictability, and having a pricing model and system that we can see out in time so we can plan our business more long term. That predictability in pricing is going to be key. A lot of the things that Ms. Fralick said around regulatory regime, etc., I agree with.

I'll turn it over to Jim, if he has anything to add.

[Jim Keon]

Yes, we have the largest R and D company in Canada, as Peter mentioned. We also have the largest company in Quebec. I think that while we are focused on the vaccine, our message today is we have thought about this. We put out a blueprint on how we ensure that three-quarters of the medicines that are critical, that are genericized, continue to flow into Canada so other countries can't put up export blocks in other ways. We want to strengthen and build our industry in Canada.

We are recommending the government also build up safety stocks so if there's a wave two or a future pandemic or problem, we're more ready than we were this time.

[The Chair, Liberal, Ron McKinnon]

Thank you very much.

We go now to Dr. Kitchen for five minutes, please.

[Robert Gordon Kitchen, Conservative, Souris—Moose Mountain, SK]

Thank you, Mr. Chair.

Thank you, everybody, for being here today. Your presentations are greatly appreciated, enlightening us and educating us a little more on a lot of the stuff we've heard.

Throughout these meetings we've heard significant responses on issues. One that is concerning to me, and I've heard from most of you today, is the issue of supply chain challenges and risks. I believe Mr. Keon talked about how the movement is slower and more costly. We've heard about potential drug shortages, etc.

I go back to a number of meetings, when I was looking at things a little more closely than I have today, when there was a shortage of Epinephrine, and Diovan, Gabapentin, Carbathol, Cyclosporine, Novamoxin. Many of these drugs are definitely needed by Canadians today. We're seeing shortages of them.

It would be interesting to hear comments. Dr. Neame, I think you mentioned potential supply issues. I'm wondering if you could start. We would then go on to the CGPA.

[Dr. Dion Neame]

My expertise is in vaccines.

It is extremely difficult to make biologic products. If you're developing an infant vaccine, for example, Pediacel, if you have a quality issue, that whole vat will have to be removed, and that is an 18-month delay. We have to replenish the supply. It's very challenging. We do everything we can to maintain the integrity of our manufacturing processes, and that's why our levels of quality are so high. Health Canada inspects us regularly.

We do our best. We're trying not to have breakdowns in supply, but it is part of the manufacturing process. We work with Health Canada. We have drug shortage notification protocols on the Health Canada website. Whenever we are in a situation where we start to run short, we will always post them. If it's a situation where a patient is running into a drug shortage, we always ask them to call their health care professional to look for alternatives.

[Robert Gordon Kitchen, Conservative, Souris—Moose Mountain, SK]

Ms. Fralick, do you have any comments?

[Pamela Fralick]

No, consistent with Dr. Neame, we've been monitoring very vigilantly throughout this time. We check with our members regularly. We do everything we can to make sure that drugs are in full supply. Our members have told us there have not been problems. This is on the patented drug side. Mr. Keon's organization has a slightly different position. Essentially, we've been monitoring it.

We've been supportive of the 30-day refill limit during the worst of the pandemic to make sure the drug supply is consistent. Right now we've been very fortunate that there have been no significant issues in the supply of any of the drugs our members produce.

[Robert Gordon Kitchen, Conservative, Souris—Moose Mountain, SK]

Thank you.

Mr. Keon, I'll get you to try to answer that first question, but I'd like to throw this into it as well. In your executive summary you talk about how warehouse and vault capacity might be a challenge and a risk that we'd see in the supply chain. We've heard about particularly the NESS storage, where masks, etc., were becoming obsolete in terms of expiry dates and so on. I'm wondering how that might fit into some of your comments dealing with the issues that you would see that we need to move forward on.

[Jim Keon]

The issue of drug shortages has been an issue, for the last five years and more, worldwide. It's not just a Canadian issue. I think part of it has been the interaction of increased regulatory scrutiny around the world. Agencies have gone to locations where they hadn't before. I think that's a good thing. Products are safer than before. When it's also combined, however, with very low pricing in Canada and internationally—the “how low can you go" model that I touched on earlier—I don't think it works.

I quoted the Deputy Prime Minister earlier in my comments. I think we need to step back and look at the pricing situation. We need to develop a policy around trying to encourage domestic production, domestic R and D and manufacturing, plus, as you mentioned, warehousing and vault capacity. These are all expensive investments to make. We want them here. We want them in Canada. With regard to pricing, plus some of the regulatory flexibilities that Health Canada has shown during the pandemic, we're arguing that we'd like to look at those going forward. If products can be brought in safely during this pandemic period, we think that can go forward.

I know that Peter wanted to say a couple of words on this too, if we have time.

[Peter Hardwick]

From the generics industry perspective, and again from an Apotex perspective, any drug shortage is an issue. I would say, however, that one thing we have to learn from this pandemic is this: Strengthen our domestic manufacturing capabilities. Canada is 2% to 3% of the global pharmaceutical market. My key message today is that we need to learn from COVID-19. What happened around the world was that there were restrictions on exports.

I can tell you that what gets me out of bed in the morning, as it does all of my colleagues, is the patient dealing with anxiety, depression, cardiovascular illness or oncology. We go to work every day to make sure there's a continuity of therapy for Canadians. We need to make sure. A lot of the manufacturing has left this country.

In terms of what Apotex produces, almost 80% of all the drugs we sell are manufactured in Ontario for Canadians. I can tell you two stories. There was a global shortage of tamoxifen. Were it not for our facilities in Canada.... We actually reprioritized all of our production schedule for Canadians. No one's doing—

[Robert Gordon Kitchen, Conservative, Souris—Moose Mountain, SK]

Mr. Hardwick, while I still have you here—

[The Chair, Liberal, Ron McKinnon]

Thank you, Dr. Kitchen—

[Robert Gordon Kitchen, Conservative, Souris—Moose Mountain, SK]

—Mr. Davies talked about remdesivir. Do we have the capacity to make that?

[The Chair, Liberal, Ron McKinnon]

Dr. Kitchen, thank you.