Health Committee on Oct. 16th, 2018

[Christine Moore, NDP, Abitibi—Témiscamingue, QC]

Thank you very much.

Mr. Edwards, parents who have children with a rare genetic disease are often left to their own devices. They are told that there is currently no treatment coverage in Canada, and they then do their own research online. They realize that the costs associated with these drugs are high, that they are not covered and that, sometimes, they are only available in other countries. They have to buy them on the Internet, and they are at risk of receiving fake drugs.

What can we do to ensure that Canadians are more quickly connected to people doing research on different rare diseases?

[Dr. Aled Edwards]

If I understood correctly, one of the problems is that for most rare diseases there are no medicines at all. When you're talking about unaffordable medicines that parents are trying to get, that's what we're trying to fix.

There's the problem of today, which as you say is how parents get their medicines, and there are the problems of tomorrow, which we as researchers are interested in: How do we make affordable medicines for all these children, so they never have to do as you're saying?

To your specific question, I can't tell you the answer, but we're trying to argue that Canada should try to make it happen, such that these children—and the parents, obviously—have affordable medicine and are not forced to make difficult decisions and do things to get access to medicines they can't afford and that aren't available.

[Christine Moore, NDP, Abitibi—Témiscamingue, QC]

Parents sometimes tell me that they have found a drug, but that it's only available in the U.S., that it isn't approved in Canada and that they can't get it here. They end up in somewhat difficult situations. No one puts them in contact with a specialist in the field in Canada or tells them who they could contact.

What could the government do to improve so that Canadian patients and researchers with expertise in Canada can be connected so that these patients receive information on clinical trials or on what has been done outside the country?

[Dr. Aled Edwards]

I don't know how the treatment of these patients...but presumably, when we have friends like Kym Boycott at CHEO, they know all the network of folks. It's a very close community and it's close to these rare disease researchers. When it's not available in Canada, our regulators are slower than in many aspects of Canadian regulatory life; it's not just medicine. Our regulators tend to be more cautious than the American ones, so inevitably it's available in America first. The solution is, as you say, to go to the clinics and talk to the physicians that Genome Canada supports. They will have good advice as to what is and what is not a good medicine and where to get it.

The problem of accessibility is due to our regulators.

[Christine Moore, NDP, Abitibi—Témiscamingue, QC]

Mr. LePage, do you want to add anything?

[Marc LePage]

Yes. It's a dynamic we're quite familiar with.

As Mr. Edwards mentioned, people who have connections in the research community are able to find partners in the network of researchers working in another province as well as other families in the same situation. Solidarity between families whose members suffer from a rare disease is very important.

What is still missing is a clinical network. For people who are not in contact with research communities, it is difficult. They go to the hospital and they are alone, which is why the project we have proposed is important. It would make this link with a pan-Canadian and even international network, with other communities. In many cases, this solidarity extends beyond the country's borders.

Intervening with the diagnosis and knowing exactly what the disease is is already a step forward. In some cases, drugs exist, but in others they don't. Sometimes, the intervention may concern the nutritional aspect. There may also be situations where surgery is required. Drugs aren't necessarily prescribed in all cases.

Nevertheless, there is still no network between the so-called normal hospitals. People living near Sainte-Justine Hospital, CHEO or SickKids in Toronto may have an advantage, but it is still a problem in remote areas. That's why we are proposing that the clinical world do what has been successfully done in the research world.

[The Chair, Liberal, Bill Casey]

Time's up. Sorry.

We'll now go to Mr. Saini, who is the mover of this motion. It's turned out to be quite interesting and informative.

[Raj Saini, Liberal, Kitchener Centre, ON]

Thank you all very much for coming here today.

I'm going to start off my comments with a highlight. For disclosure, I am a practising pharmacist, so I have some knowledge in this area. I'm going to start off by highlighting a particular problem. You raised many issues, but let's focus on something that's going to confront all of us. Let's talk about Alzheimer's.

Right now we have 45 million people worldwide who live with this disease. I don't have the Canadian figures, but we can extrapolate. The current cost in the United States to treat this disease is $225 billion every year. By 2050 the cost will go up to $1.2 trillion.

Between 2010 and 2012 we had 413 clinical trials. We had 244 potential drug candidates. We had a 99.6% failure rate between phase I and phase II. Currently we have no cure.

You mentioned also, Dr. Edwards, that when it comes to diabetes, you have the subgroups when it comes to personalized medicine. You're going to face the same situation when you come to Alzheimer's. You also said there's no law of physics that says that a company must produce, distribute, and come up with the potential drug candidate. Open science, to me, is the one aspect going forward that can fold in all the issues that we're having, whether with current diseases—diabetes, heart disease, Alzheimer's—or neglected diseases, especially the 12 or 13 tropical diseases that nobody talks about anymore. We have to change the ecosystem among government, industry, researchers and financiers.

This is such a broad topic, but I want the committee to get an understanding of what can be done practically right now. We are a small science power. We represent less than 2% of the global pharmaceutical market. What can we do? Given our lack of finances compared to those of the bigger countries or the richer countries, what can we do to lead the process forward, to change fundamentally research not only in Canada but around the world? The diseases we're talking about are going to affect not only Canadians. They're going to affect people worldwide, so it's incumbent upon us, being an educated country, not only to worry about our own citizens but also to provide a step forward for those citizens who live in different parts of the world and who don't have the same access we do.

What fundamentally, practically, can we do to change the ecosystem so Canada can be a leader as opposed to a follower? I can ask everybody for their comment on this.

You can start.

[Dr. Aled Edwards]

Okay.

The Alzheimer's example is a great one. The beta amyloid hypothesis has been tested by about 10 companies. Probably about $20 billion has gone into that hypothesis. All the companies did it in secret. We're still no wiser as to whether that hypothesis is true or not for Alzheimer's. It was a tragic waste of money. If one had imagined a different universe where we tested that hypothesis once or twice in the open, then 10 people wouldn't have had to spend $2 billion each and we would have come up with the answer transparently.

We are a small country, and what can a small country like Canada do? I would argue that we can change the behaviour and the incentives in the ecosystem. We are leaders in open science. Our organization, the Montreal Neurological Institute, has just gone open. They're not filing for patents. If we can get more and more people to follow, we'll use the existing global spend more efficiently.

There is not going to be a bag of money that everyone can get, so we're currently using the existing bag in a highly duplicative way. Everyone's doing the same experiment, nobody's sharing, and we're not learning. If we change the model, we'll get far more impact per dollar. That's my suggestion. They're looking for a leader to do that, and I think we can do it here in Canada.

[Raj Saini, Liberal, Kitchener Centre, ON]

Mr. LePage, would you comment?

[Marc LePage]

I would agree with Aled's comments. In fact, I remember that when we funded the original SGC, the whole idea was to have open science discovery of drug targets and then maybe to have 10 companies go after those targets, increasing the likelihood of something coming out, instead of patenting too early and having a very narrow approach. It's open science, and that has evolved. That continues to be one of our responses to it.

I'd have to say in terms of our genomics activity in the neurosciences more broadly, it's the most difficult area. We have to keep plugging away at it. It's probably the area in which we've made the least amount of progress. We should continue to go at it, not just in Canada but around the world.

[Raj Saini, Liberal, Kitchener Centre, ON]

Dr. Yusuf, would you comment?

[Dr. Salim Yusuf]

Mr. Saini, you asked two big and broad questions. I'll deal with both because we've been working in both areas for about 20 years.

With Alzheimer's, it is a long-term process, and the current business model is that you need to get your results within a few years in order to make money from your patented drugs. Alzheimer's develops over 20 or 30 years, and there is recent data that suggests that the beta amyloid hypothesis is not wrong; it is factors in middle age that affect disease in old age. Therefore, we need mechanisms whereby we can study people for 20 to 25 years to affect the course of the disease. We have studies in which we intervened in the year 2000, and we're still counting whether that had an impact. This can only be done through the public purse at the moment, so I think a long-term national initiative on Alzheimer's, a 25-year strategy, would make sense.

If I may, I'll now switch to your second question on neglected diseases.

I'm a person from India, originally. I've worked in 100 countries, of which 80% are low- and middle-income countries in Africa, South America, and Asia. We've worked on three areas—TB pericarditis, which is neglected completely; Chagas disease, which affects 10 million people in South America; and rheumatic heart disease, which kills about 400,000 people every year in Africa, Asia, and South America. What we've been able to do is squeeze the juice from our western countries, take the drops, and invest them in those areas.

We have the largest research programs there. We've used that to write CIHR grants—this is where public funding becomes important—leverage that money, and institute some of the biggest studies in the world. We've been bringing people in and training them in Canada. We also send teams out to many of these countries to train people.

You're right; there is a big need for trying to address neglected diseases, but it can only be done by a model that includes not only open science but also open capacity-building in these countries. That's what we've been doing, and I think federal funding and corporate social responsibility become key to it.

[Raj Saini, Liberal, Kitchener Centre, ON]

I have one quick question with just a yes-or-no answer.

In the U.K., the research councils there have now put regulations in place to the effect that if there is any government funding, the research that emanates has to be in the public domain.

Yes or no, is that a good idea?

[Dr. Salim Yusuf]

I give a qualified yes.

[Dr. Aled Edwards]

But it's also not true. They're allowed to patent the results and keep things secret; it's the publication that has to be in the public domain. The background intellectual property can be....

We have a story on one of the universities in England. For 18 months, we have not been able to sign the deal. They're going to give us information, we're going to do the experiments, and they want to own all of our intellectual property. We say no; we want to share it.

Universities are structured in our ecosystem to look after their intellectual property. The rules are that once you publish the paper, the paper must be public, but that still could be patented and unuseful to the world.

[The Chair, Liberal, Bill Casey]

Thanks very much.

That concludes our seven-minute round.

We'll go to our five-minute round, starting with Mr. Lobb.

[Ben Lobb, Conservative, Huron—Bruce, ON]

Thank you very much, Mr. Chair.

That kind of led off the first part of the question that I had for the group today.

I was on the industry committee, and we studied some of these very topics. I was on the health committee years ago, and we studied this very topic, and here we are again, studying this very topic.

The question is—and I'm sure among scholars this is quite a debate—if the government is providing federally funded money to universities and researchers, etc., who should own the intellectual property? Should there be any intellectual property? When there are public dollars that are going forward for research in the public good, how is it that a researcher in a university lab has the ability to own that intellectual property?

Does anybody have any thoughts on that?

[Marc LePage]

I think that in most of the universities in Canada, in fact it's the university that owns the intellectual property. There are a few universities where it's the individual, but in most cases—and I've worked in San Francisco and places like....

As an economic model, that model has been very successful in the U.S. in terms of deriving benefit from health research. That is the model.

[Dr. Salim Yusuf]

It's a question that we face many times.

I think the first thing is to say that public funding, even for studies that are “funded publicly”, does not even cover a half of the cost, so the investigator in the university has to bring added money. Second, unlike many countries, Canada does not fund the time of investigators. I fund my time by doing clinical work on the weekends, and then I use that money to support me to do pro bono work for research, and I'm not the only one. Most clinical scientists in Canada do that.

I think there's a myth that public funding means that's the only money that has led to a discovery. No. That is a key part of it, but it's leveraged multiple times. When we reframe the question in that context, then we make it a different answer.

[Dr. Aled Edwards]

There are obviously lots of studies about this. When universities started to own their intellectual property, it was driven by the American government when they passed the Bayh-Dole Act in the early eighties. That created that idea that it's too complicated for governments to manage intellectual property, so let's give it to the universities, and that created what we have today, which is universities acting like little companies.

They don't manage their intellectual property well. Canada loses money. If you just do a financial check on how much we gain and lose at our universities, you see we lose money on our intellectual property portfolio. The intellectual property we invent is so early it's not a product yet. Actually, there's strong evidence that it gets in the way of creating products that are useful for society.

It wouldn't be such a bad deal if we got out of the business of trying to pretend we're little companies at universities.

[Ben Lobb, Conservative, Huron—Bruce, ON]

I've talked to many software companies—not pharmaceutical companies, but I'll use the software example—where there's been federal money, the universities maybe found some granters, and the companies chipped in money. The universities come up with a great idea, and now they have to negotiate with the university to actually use this great technology. To me it's bizarre.

The other thing I want to talk to—and I know I'll probably run out of time here—is I'm sure all of us around the table meet with many pharmaceutical companies and pharmaceutical executives. They praise the tier 1 status that Canada has, but I heard in somebody's comments this morning that the pharmaceutical investment in this country is declining. Still we hear from all the executives of these pharmaceutical companies about the great benefit of being a tier 1 country. Does anybody want to throw that out there?

[Dr. Aled Edwards]

On the pharmaceutical sector, if you think of the corporate structure, the CEO has sales and marketing divisions that have CEOs in every country, and they have global research and development that invents the new medicines. There used to be some global research and development sites in Canada, but there are very few anymore. The research guys, the guys who every day, passionately, want to invent medicines and help people, are on the research side. The Canadian CEOs report up to sales and marketing, which is quite distinct from the organization that actually does research on new medicines, so the messages the Canadian government is going to get are filtered through.... Their compensation is selling more, expanding their market and stuff, and they're doing completely appropriately what their job is, which is try to increase their sales.

I think you need some sophistication about what pharma is. It's two different organizations under one big umbrella. If you call it one thing, then I think you're going to get messages that are almost incomprehensible. That's the way I like to think about it.

[The Chair, Liberal, Bill Casey]

Thank you.

Go ahead, Dr. Yusuf.

[Dr. Salim Yusuf]

I think we have to think of why global pharmaceutical companies would invest in Canada.

First, we need something special to offer. We're a tiny part, population-wise, of the world. We need special expertise that is better than the U.K., the U.S., Japan or Korea. There are some areas where we are special, and when that happens, they invest in us.

The second part is tax advantages. Tax breaks have made a difference to companies investing through Canada.

The third is that our marketplace is going to remain tiny. We're a small country relative to the world. That is a factor we cannot beat, but we can try to build Canadian expertise by investing heavily in research in the university. That in turn will bring in global pharma. The second factor here is that there is practically no investment from the local Canadian pharmaceutical industry or device industry into research. Our generic industry charges the highest generic prices in the world and does not invest very much in research.

I think this committee needs to look at the behaviour of the generic industry as well, on one hand, and on the other hand at the factors that will attract money from global industry so they divert it from Europe, the U.K., Australia, and the U.S. to us.