Evidence of meeting #31 for Health in the 43rd Parliament, 1st Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was vaccine.

A recording is available from Parliament.

On the agenda

MPs speaking

Also speaking

Scott Halperin  Professor of Pediatrics and Microbiology and Immunology, Dalhousie University, and Director, Canadian Center for Vaccinology
Peter Hardwick  Chief Commercial Officer and Executive Vice-President, Apotex, Canadian Generic Pharmaceutical Association
Jim Keon  President, Canadian Generic Pharmaceutical Association
Pamela Fralick  President, Innovative Medicines Canada
Dion Neame  Country Medical Lead, Sanofi Canada, Innovative Medicines Canada
Mario Possamai  Senior Advisor, Commission to Investigate the Introduction and Spread of Severe Acute Respiratory Syndrome (SARS), 2003-2007, As an Individual
Paramvir Nagpal  Founder and Chief Executive Officer, Mapsted
Patrick Hupé  Senior Director, Health System Strategies, Medtronic Canada

11:50 a.m.

Liberal

The Chair Liberal Ron McKinnon

Thanks you, Mr. Desilets.

We go now to Mr. Davies for six minutes.

July 6th, 2020 / 11:50 a.m.

NDP

Don Davies NDP Vancouver Kingsway, BC

Thank you, Mr. Chair.

Thanks to the witnesses for being with us today.

Mr. Keon, you were quoted recently as saying the following with respect to the provisions of the COVID-19 Emergency Response Act, which provides the federal government, or anyone it designates, with the authority to make, sell or use patented inventions to the extent necessary to respond to a public health emergency:

The ability of a country to issue compulsory licenses for medicines and other urgently needed items to respond to a health crisis is not a novel approach, and is embedded in international trade agreements such as the WTO Agreement on the Trade-Related Aspects of Intellectual Property Rights. This is a prudent and reasonable precautionary measure.

Given that this authority in the legislation is set to expire on September 30, do you believe that Parliament should extend it?

11:50 a.m.

President, Canadian Generic Pharmaceutical Association

Jim Keon

Yes, we made that comment. The government moved with emergency measures in March when the COVID shock first hit. I think while we support that legislation, to be very honest, it has not been our focus. Our focus has been on the 75% of the medicines that we are now producing and that we are able to continue to manufacture and provide to Canadians. When a vaccine is developed, we will see what the situation is, but our focus right now, as I said, is on ensuring that those three out of four medicines that we now produce, providing billions in savings to the health care system, are protected and that we have greater access to them going forward.

11:55 a.m.

NDP

Don Davies NDP Vancouver Kingsway, BC

Okay. Before I leave that area, I'm curious about your comment on one aspect of this. Remdesivir, which is the first drug approved by licensing authorities in the U.S. to treat COVID-19, is made by Gilead, and that's been shown to help people recover faster from the disease. The first 140,000 doses supplied to drug trials around the world have been used up, and we now see that the Trump administration has now bought more than 500,000 doses, which is all of Gilead's production for July, and 90% of it for August and September.

In your view, should Canada issue compulsory licences in order to secure a sufficient domestic supply of COVID-19 treatments like remdesivir?

11:55 a.m.

President, Canadian Generic Pharmaceutical Association

Jim Keon

I won't speak for Gilead because they're not a member of our group, but in general the trials on remdesivir are ongoing. It appears that it has had some effect in reducing the morbidity of COVID-19, so that's excellent. I think when the approvals are forthcoming stating that it is an effective treatment, we'll see whether Gilead is making the product available by licensing. I think it already has around the world licensed the product, in particular in developing countries. We'll see how that evolves in Europe and Canada and the U.S. and whether there's an issue there. Right now, though, my understanding is that the product is available in Canada for use.

11:55 a.m.

NDP

Don Davies NDP Vancouver Kingsway, BC

Thank you.

Dr. Halperin, if you know this, what stage are you at in terms of studying the safety and/or effectiveness of the CanSino Biologics vaccine candidate?

11:55 a.m.

Professor of Pediatrics and Microbiology and Immunology, Dalhousie University, and Director, Canadian Center for Vaccinology

Dr. Scott Halperin

The phase one and phase two of the CanSino vaccine in Canada has not started yet. Its start is imminent. The final approvals that are required to have the vaccine shipped to Canada are being finished. Once that happens, we'll be starting the trials here. As you're aware, the vaccine has undergone phase one and now phase two studies in China. Studies designed for Canada are a little bit different, to expand the information about the vaccine.

11:55 a.m.

NDP

Don Davies NDP Vancouver Kingsway, BC

Staying with that, Dr. Halperin, in a May 19, 2020, news release from Dalhousie University, you noted that the intellectual property rights for that vaccine will “stay in Chinese hands”, but the National Research Council's involvement would help ensure that Canada gets its guaranteed domestic supply.

Precisely what conditions are in place to ensure that Canada will receive a sufficient domestic supply of the vaccine if it proves to be successful?

11:55 a.m.

Professor of Pediatrics and Microbiology and Immunology, Dalhousie University, and Director, Canadian Center for Vaccinology

Dr. Scott Halperin

From my understanding of the agreement—and again, that's an agreement between the National Research Council and CanSino—the National Research Council is being provided with the seed stock of the vaccine and will be able to manufacture it in Canadian facilities, not for sale but for utilization in Canada, once the Canadian manufacturing capability is up and running. It's by that method that Canada's supply will be assured because we'll have the manufacturing capacity here in Canada.

11:55 a.m.

NDP

Don Davies NDP Vancouver Kingsway, BC

Thank you.

Back to you, Mr. Keon, I understand that the generic industry has a different take—I think it would be fair to say—on the amount of research that is being done by pharmaceutical companies in Canada and whether or not they in fact have met the 10% commitment that they made back in the 1980s as a condition of receiving extended intellectual property protection.

What's your association's view on that?

11:55 a.m.

President, Canadian Generic Pharmaceutical Association

Jim Keon

We've been clear. The commitment on intellectual property has not been reached for many years now. I think that's a matter for IMC to address with the government.

We have particularly raised this point when there have been discussions in international trade agreements, where countries like the United States, or the European Commission, have pressured Canada to increase intellectual property protection. We have pointed out that, in the past, when Canada made agreements around certain levels of research and development in return for greater intellectual property protection, it didn't work out. We continue to say that in trade agreements, intellectual property protection in Canada needs to be addressed from a Canadian perspective. You need to look at the amount of research and development, the jobs and the health care savings available.

Every year that a patent or intellectual property is extended means that the generics, which are priced in some cases at a 90% discount, will not be available. That's a very high price to pay in the health care system.

Noon

NDP

Don Davies NDP Vancouver Kingsway, BC

Ms. Fralick, if I may, I'll direct my final question to you.

The Government of Canada estimates that proposed reforms to Canada's drug pricing regulations—you referred to them as the PMPRB proposals—will save Canadians $13.2 billion over 10 years on patented drug costs. They say the new rules will save money for patients, employers and insurers, at the expense of drug industry profits.

In response, Innovative Medicines Canada has argued that these regulatory changes will result in fewer clinical trials and new medicines being available for sale. However, Doug Clark, executive director of the Patented Medicine Prices Review Board, has stated publicly that there is virtually zero correlation between prices and drugs coming to market, R and D spending and clinical trial intensity, in any country that the PMPRB has looked at.

How do you respond to Mr. Clark's position?

Noon

President, Innovative Medicines Canada

Pamela Fralick

Thank you very much for the opportunity to respond to that. I also have something to add to your previous question to Mr. Keon, if there is time.

We looked at Health Canada data—it isn't our data but Health Canada's data—and compared the data from Q4 2019. The regulations were passed on August 21, 2019. We looked at Q4 and how many new drugs were brought into Canada versus the previous three years. Depending on the year, there is about a 50% decrease on drugs being brought to Canada. I noted that Mr. Clark said that perhaps we don't have all the data, but if we don't, then I hope he would share that with us. Similarly, using Health Canada data, we've noticed that clinical trials have dropped between 38% and 47% in that same quarter, so the evidence is very clear to us.

Very recently, a literature review of about 49 papers that looked at the link between pricing and drug launches was released. It showed, clearly, that 44 out of these 49 papers that were reviewed found a significant negative relationship between drug price controls, or a significant positive relationship between drug price levels. There are more details on this. I know we don't have time, but I'm happy to share the information with you. The bottom line is that there is absolutely no question in our minds that there is a very clear link between pricing and drug launches, as well as investment and obviously, at the end of the day, access to medicines.

I would like to make one other comment vis-à-vis your question around investment, because that really was more about our members and the commitment with PMPRB to invest 10% of our revenues. The definition that was reflected in the PMPRB agreement was a very particular program, SR and ED, which you are probably familiar with, a tax credit program. At that time, the industry did commit to 10%, and for many years it increased its investment in that program. The problem is that the industry has changed. The world has changed in 30 years, so while it is accurate that the industry only contributes now about 5% rather than 10% in SR and ED, it does commit at least 10% of its revenue to R and D in this country.

One example...and we've been talking about this throughout the morning. Clinical trials are a critical piece of the research process. At any given time, there are about 4,500 going on in Canada. They are funded by this industry. Health Canada does not consider that research. Many of you will be familiar with MaRS in Toronto, and JLABS, which is an incubator for new research, with millions of dollars poured into that annually. That is not included.

The Government of Canada has recognized that the definition of research and development does need to be modernized. ISED and StatsCan have a project with the industry where we have redefined what R and D means, and the data is being calculated as we speak. Ernst and Young did a study a couple of years ago, and that's why we've come up with the 10%—it's actually 9.97% of revenue. The industry is a very strong contributor to R and D in Canada and would like to do more if circumstances and the situation were more amenable to that.

I'm sorry for going on at length, but I felt you deserved an answer to those questions.

12:05 p.m.

Liberal

The Chair Liberal Ron McKinnon

Thank you very much.

We will start the second round with Mrs. Jansen, for five minutes.

12:05 p.m.

Conservative

Tamara Jansen Conservative Cloverdale—Langley City, BC

Dr. Halperin, how much money has your research centre received from the federal government for work on vaccines with CanSino Biologics?

12:05 p.m.

Professor of Pediatrics and Microbiology and Immunology, Dalhousie University, and Director, Canadian Center for Vaccinology

Dr. Scott Halperin

At this stage, we have an agreement. We're not receiving any funds from CanSino. The funds are from the Canadian government, the National Research Council.

12:05 p.m.

Conservative

Tamara Jansen Conservative Cloverdale—Langley City, BC

How much is that?

12:05 p.m.

Professor of Pediatrics and Microbiology and Immunology, Dalhousie University, and Director, Canadian Center for Vaccinology

Dr. Scott Halperin

I am not sure of the exact amount. It's in the range of approximately $800,000. We haven't received any funds as of yet, but the agreement is done. The funds will come in once the study starts.

12:05 p.m.

Conservative

Tamara Jansen Conservative Cloverdale—Langley City, BC

Isn't it true that the vaccine you're working on with CanSino uses a very similar platform technology—specifically the modified adenovirus vector expressing the virus's S protein—to another vaccine that's already being worked on at Oxford University?

12:05 p.m.

Professor of Pediatrics and Microbiology and Immunology, Dalhousie University, and Director, Canadian Center for Vaccinology

Dr. Scott Halperin

It's a different vaccine. The Oxford vaccine uses the chimpanzee adenovirus. As Dr. Neame mentioned, that's not expressing the protein but expressing the genetic material that then produces the protein. CanSino's is an adenovirus 5, which is a human adenovirus strain, and it expresses the spike protein.

12:05 p.m.

Conservative

Tamara Jansen Conservative Cloverdale—Langley City, BC

It's more alike than it's different. Is that correct?

12:05 p.m.

Professor of Pediatrics and Microbiology and Immunology, Dalhousie University, and Director, Canadian Center for Vaccinology

Dr. Scott Halperin

It's a similar platform. There are about five or six different platforms. This is one platform, which has another organism, a non-pathogenic organism, express the proteins of SARS-CoV-2.

12:05 p.m.

Conservative

Tamara Jansen Conservative Cloverdale—Langley City, BC

The Oxford University vaccine is already in the final phases of clinical trials, phase three, and one of the world's leading pharmaceutical firms, which was mentioned already, AstraZeneca is already manufacturing hundreds of millions of doses to be ready by the end of the year, where in comparison, according to ClinicalTrials.gov, your trial at Dalhousie is not even recruiting patients yet for phase two trials and the company that you're partnered with, CanSino, hasn't sold a single product outside China.

With respect, how is it possible that Dalhousie and CanSino will be able to outrace Oxford and AstraZeneca to a vaccine?

12:05 p.m.

Professor of Pediatrics and Microbiology and Immunology, Dalhousie University, and Director, Canadian Center for Vaccinology

Dr. Scott Halperin

The race is for successful vaccines, not just a vaccine. As Dr. Neame mentioned, we need vaccines and we need multiple vaccines. It's not just because of manufacturing capability, but that is clearly one reason. We need multiple companies with multiple facilities to produce vaccines that are going to have a global demand. Also different vaccines and different platforms may turn out to be more effective in different subpopulations. For example, there may be vaccines that work better in the elderly, others that work better in young, healthy adults and others that work better in children.

We need multiple vaccines, so we want to support any vaccine that is successful.

12:05 p.m.

Conservative

Tamara Jansen Conservative Cloverdale—Langley City, BC

I understand. It's like having more than one iron in the fire.

Last week we learned that CanSino is skipping the phase three trial. Its vaccine is going to be injected into Chinese soldiers. Not only would that never happen in Canada, but soldiers cannot insist on informed consent. That's obviously against the rules of medical ethics.

Have you told the government that you will refuse to work with such a partner, which is violating those medical ethics, and if not, why not?