Health Committee on Oct. 16th, 2018

[The Chair, Liberal, Bill Casey]

I call the meeting to order.

Welcome, everybody, to meeting number 115 of the Standing Committee on Health.

Welcome to our guests.

Before we go to our guests, I have just a few little things we have to deal with.

The number one issue is the budget. We passed around a budget for this project, for this study. We just need somebody to move a motion to approve the budget and somebody to second it.

It is moved by Marilyn Gladu and seconded by Ron McKinnon. That problem is solved.

Second, I need unanimous consent. Dr. Yusuf's presentation this morning is only in English, and.... We don't have unanimous consent, so we can't pass that around.

Third, I just want to remind the NDP and the Conservatives that we still need unanimous consent in the House of Commons to make the minor change to the soft drink report, or the premixed drink report. Remember we did it in here, but it will have to come back. Just make sure your House leaders know that we've approved it here, and it will come up at the House leaders' meeting sooner or later.

The last issue is about the next meeting on Thursday. The Prime Minister of the Netherlands is scheduled to make an address in Parliament at 10:30 a.m. I think we'll have to end at 10 o'clock to get in our seats in time for the presentation by the Prime Minister of the Netherlands in the House. Next Thursday, we'll end at 10 a.m.

That's it for the committee business.

Today we have with us Dr. Keith Fowke, Professor, Department of Medical Microbiology and Infectious Diseases, University of Manitoba. Welcome.

As an individual by video conference from Hamilton, we have Dr. Salim Yusuf, Distinguished University Professor of Medicine, Population Health Research Institute, McMaster University and Hamilton Health Sciences. Welcome, Dr. Yusuf.

From Genome Canada, we have Marc LePage, President and Chief Executive Officer, and Cindy Bell, Executive Vice-President, Corporate Development. Welcome.

From Structural Genomics Consortium, we have Aled Edwards, Chief Executive Officer, and Maxwell Morgan, Director of Policy and Legal Counsel. Welcome.

I'm going to invite Dr. Fowke to open with a 10-minute opening statement.

Dr. Fowke, you may start. We'll let you know when we hit 10 minutes.

[Dr. Keith Fowke, Professor, Department of Medical Microbiology and Infectious Diseases, University of Manitoba, As an Individual]

Thank you very much, Mr. Chair, and thank you to the committee for the opportunity to present.

My name is Keith Fowke, and I'm a researcher based at the University of Manitoba. I'm the head of my department of medical microbiology and infectious diseases, and I also function as the chair for CIHR's advisory committee on HIV/AIDS research.

As a university-funded and university-based researcher, mainly funded by the Canadian Institutes for Health Research since 2001, I'd like to make the point that federally funded, investigator-initiated research has benefits for reducing health care costs, including drug costs. I'll provide just one example of this potential.

I'll try to demonstrate that our research suggests that we may prevent new HIV infections using safe, affordable and globally accessible anti-inflammatory drugs like acetylsalicylic acid, or ASA, which is also known as Aspirin. Yes, that's right: I'll try to suggest to you today that it may be possible to prevent new HIV infections using Aspirin.

What's the scale of the problem that we're talking about? In 2018, there were 1.8 million people globally who were infected with HIV each year, the majority of whom were in sub-Saharan Africa. Globally, new infections have not declined very dramatically. Over the last 10 years, they have remained relatively flat. In the Canadian Prairies, we have a growing epidemic of HIV, especially in our indigenous communities.

HIV prevention methods, such as condom use, are not possible for everyone, especially when gender-based power differentials exist. Access to HIV medications that can be used to prevent HIV infections are not always available to everyone that needs them in the community. Therefore, we need new HIV prevention approaches to be added to our HIV prevention tool box.

My research, funded by CIHR and Grand Challenges Canada, focuses on understanding the mechanisms of why some Kenyan women, who are intensely exposed to HIV, fail to become infected. We have determined that these women have, in their genital tracts, naturally low numbers of the type of cell that HIV preferentially infects. Our goal has been to determine how to induce this reduction in genital tract HIV target cells in other women who are at risk of acquiring HIV.

At its most basic level, HIV infection requires a fit virus and a susceptible cell. Once that cell has been infected, usually in the genital tract, the virus quickly spreads throughout the body in a matter of a few days. Most HIV prevention efforts focus on trying to keep the virus away from the cells, focusing on things like condoms, or crippling the virus using anti-HIV drugs. However, we've taken the approach of trying to limit that HIV target cell from migrating to the genital tract in the first place. Without a susceptible target, HIV viruses are cleared from the genital tract and the body is not infected.

How can we prevent this HIV target cell from getting into the genital tract? The process of immune cells moving from the blood into tissue is called inflammation. We rationalized that perhaps using an anti-inflammatory drug would help reduce the number of target cells moving from the blood into the genital tract. When deciding which anti-inflammatory drugs to test, we chose to test drugs that were globally available and affordable and that had a strong track record.

ASA was the leading choice because it is an anti-inflammatory drug and hundreds of thousands of people safely use it daily for the prevention of cardiovascular disease. Most importantly, it's already there, sitting in every small kiosk throughout the world and in developing countries. When we asked Kenyan women, they said that Aspirin was highly desirable because it was already known in the community, and did not carry any of the stigmatization that other anti-HIV medications do.

To test our theory that ASA would actually reduce the number of HIV target cells, we conducted a small CIHR- and Grand Challenges Canada-funded pilot study in Nairobi. We gave 38 women low-dose Aspirin for six weeks and we measured the number of genital tract HIV target cells before and after the therapy. Interestingly, we observed a 35% reduction in the number of HIV target cells in the genital tract following six weeks of low-dose Aspirin.

While this does not prove that ASA will actually reduce HIV infections, we feel that it is logical that if there are fewer target cells in the genital tract, then should HIV be introduced, the probability of infection would be reduced.

What are the next steps? Currently we have a CIHR-funded study to assess the optimal dose of ASA that would be required and how long the effect would last. This will pave the way for larger clinical trials that are required to assess if anti-inflammatory drugs like ASA really can have an impact on reducing HIV infections.

Studies of the use of anti-HIV drugs in HIV prevention have demonstrated that the presence of genital inflammation can reduce the effectiveness of these drugs from 75% down to 10%. In other words, we have drugs that we already know have an impact on preventing HIV infection by targeting the virus, but if there is inflammation, it reduces their effectiveness. Much like in cancer, where cocktails of drugs are used to fight off cancer, we envision that people would be provided with a cocktail of HIV prevention approaches. By combining an anti-HIV medication that targets the virus and an anti-inflammatory drug that targets the target cell, we suggest that we could create an added benefit.

Our goal is to use a safe, affordable and globally available drug like Aspirin, which may reduce the number of HIV infections around the world and be added as one of the HIV prevention approaches that are used.

There are a couple of points to consider. We never started this research looking for a link with anti-inflammatory drugs and HIV; our investigator-initiated research was focused on trying to understand the mechanism of why some people weren't infected. The data led us to this hypothesis about inflammation being important, and therefore to looking at anti-inflammatory drugs.

The choice of which drugs to be used in this study was very conscious. We wanted drugs that were extremely safe and that were globally available and affordable. This often meant generically available drugs. Using this approach, should it prove to be effective and be actually rolled out into the wider community, the timelines for rollout would be significantly shortened because the drugs are already in the community.

Finally, repurposing existing drugs to fight new diseases in different ways has the potential to save on drug spending in the long term, but it would require some short-term investments in highly innovative fundamental research.

Thank you very much for your time.

[The Chair, Liberal, Bill Casey]

Thank you very much for your presentation. It was fascinating.

Now we'll go to Dr. Yusuf, who comes to us by video conference from McMaster University.

[Dr. Salim Yusuf, Distinguished University Professor of Medicine, Population Health Research Institute, McMaster University and Hamilton Health Sciences, As an Individual]

Good morning, and thank you very much.

My name is Salim Yusuf. I was born in India and trained in medicine in India, and then received a Rhodes Scholarship. I went to Oxford and then worked in England, doing both clinical medicine and research for eight years. Then I moved to the U.S. NIH and worked there for eight years, involved in some national and global programs in heart failure.

In 1992 I moved to Canada, and I've been here ever since, for 26 years. The point I wish to make is that having worked in four countries, I have a global perspective on research. In addition, our current work involves 101 countries and more than 89 projects. It's very broad, very deep, and we have made a major impact in the prevention and treatment of cardiovascular disease that which has saved millions of lives.

The point I want to make here is not to give you a perspective on any single type of research or on any single discipline, but—as a researcher reflecting the voices of researchers across the country—to tell you about what we see as the needs.

The first is that we all agree that biomedical research is essential to improving the health of Canadians and developing a knowledge-based economy. Therefore, we have to invest in biomedical research and research as a whole.

Second, compared to other OECD countries, Canada's investment is substantially lower. It has remained the lowest for the last 15 years, and it's declining.

The third is that we need research that discovers better preventive and treatment strategies. Some of these originate in the laboratory and others originate by observations in humans, just as we heard, but all of them need to be tested in people if we need to translate discoveries into practice. Then, after finding that they are effective, we need to adapt them to our own health care system.

Unfortunately, our current pipeline of research is bottlenecked at stage one. All stages of research are underfunded in Canada, but even more so is the translation of findings into humans and from humans into the health care system.

We need to rethink not only our national strategy related to research and its funding but also its organization and its priority. Undoubtedly all of us will share the goal of creating a broad and world-class effort that's responsive to the health needs of Canadians and beyond, and develop the capacity in Canada to attract partners and also attract the best minds.

The first perspective I want to share with you is that discovery and invention are not the same as innovation and improving health. There is an overlap, but they're not the same. Only 5% of discoveries in the laboratory ever translate into improved human health. Investments across the entire spectrum are needed, especially in the second and third phases of research, and that's where Canada has failed miserably.

It is a long process to take discoveries from observation, from confirmation, to human health and ultimately into the system.

I'll give you three types of discoveries that have dramatically improved human health, all of which are known to you.

The first is penicillin. It was a serendipitous finding by Fleming, who thought certain fungi were killing bacteria in a petri dish in his lab. It would have remained there had it not been for the work of Florey and Chain, who synthesized it, isolated the active molecule, and did human studies that led to medium-sized production. Then it was taken by industry, and that was the era in which antibiotics were born. Hundreds of millions of lives have been saved since then. It would have remained in the petri dish had it not been for the translational work of Chain and Florey.

Blood pressure causes strokes. Reducing blood pressure reduces strokes and heart attacks. How was this discovered? It was discovered by taking 5,000 people in a little town in Massachusetts called Framingham, where they measured blood pressure and observed people and found those with higher blood pressure had more strokes. This was then taken by various companies who produced blood pressure-lowering drugs.

This was then tested in humans in large clinical trials that showed that lowering blood pressure was feasible, that it could be safe and that it saved lives, and now this is one of the biggest health impacts that has happened. It's the combination of basic science and population science and discoveries by industry that have led to improved human health.

We all know that tobacco is the number one killer in the world. It killed a hundred million people in the last century. It's projected to kill a billion people in this coming century. We do not understand the basic cellular mechanisms as to why tobacco causes cancers, heart disease, and 21 other diseases, but we know if people stop smoking, or if they avoid tobacco entirely, we will save tens of millions of lives, if not hundreds of millions. This is entirely population research, yet there is a schism in the level of funding for population and clinical research compared to biomedical research. I want to stress that everything is underfunded, but the first two are substantially more underfunded.

We just heard from Dr. Fowke. For him to make his discoveries come to reality, he has to do large clinical trials, and they cost money. They're in people, but they're essential.

The next slide, which is handout 4, shows you the overall funding in various countries and Canada. It is low. In the U.S. about $120 billion was spent in 2012. In western Europe it was about $82 billion; Japan, $37 billion; Australia, $6 billion; South Korea, $6 billion; Canada $5 billion.

The next handout tells you that as a proportion of the per capita funding or the GDP, Canada is about one-fourth of the U.S. and one-half of the U.K., so relative to the size of our economy, relative to the population, we are underfunded from public sources.

The next handout, which is number 6, shows you the decline in funding in Canada compared to other countries. You will see that between 2007 and 2012 in Canada, there was a 2.6% decline in inflated, adjusted growth rate. Compare that with China at the bottom, at 33%. Of course, China started low, but take Australia, which is a country similar to ours, smaller than ours. They went up 7%. Singapore went up 10%, South Korea 11%, Japan 6%. Even tiny Taiwan went up more.

During this period there was a decline in the U.S., but far less than in Canada, and they started at a much higher level. In Europe it was essentially flat. Canadian funding was low up to 2012.

What has happened since 2012? The situation has gotten worse. This is handout number 7. You will see that in the U.S. in 2012, 2.7% of the GDP was spent on research in the country. In 2016-17, it was the same. You will see that's more or less the case in the OECD countries. In Japan and in Australia there was an increase, and in South Korea there was an increase. Contrast that with the bottom line. In Canada there was a substantial decline over this period, with 1.8% going down to 1.5%.

Over the last decade and a half, we started low, we remained low, and we are declining. No wonder our global competitiveness has gone down and no wonder we're having difficulty attracting money from industry.

Handout 8 tells you the distribution of federal funds by various themes. This tells you that—

[The Chair, Liberal, Bill Casey]

Sorry; I just have to mention that we were not able to pass out the handouts, so when you refer to handout number 8, we don't have it. Because they weren't in both official languages, we were not able to pass them out.

You can still describe the information on the handout, but the members don't have the handout.

[Dr. Salim Yusuf]

Well, that's a shame. I was invited to participate last Thursday, so as you can imagine—

[The Chair, Liberal, Bill Casey]

We appreciate your participation. It's very, very helpful.

[Dr. Salim Yusuf]

Okay. Well, I hope they'll at least share it with you after translation, but I will try to explain things slowly, now that I know you don't have them.

Was what I said understood by the committee?

[The Chair, Liberal, Bill Casey]

Yes, the committee has indicated it is, and it's very plain. Your message is very clear, I think. I think most of the members seem to be agreeing with that, so you're good.

[Dr. Salim Yusuf]

Okay. Thank you very much.

I want to compare the amount spent on basic research in various countries and other forms of research. In the U.S., the U.S. National Institutes of Health spends 55% of its budget on basic biomedical research, and all other forms, which are clinical, population, translation, health systems, are about 45%, so it's approximately half and half. In the U.K., 50% is basic biomedical and 50% goes to the others.

In Canada, there's a marked divergence from that. In Canada, we've spent two-thirds of our money on basic biomedical research, and only one-third goes into translating it into clinical impact or into the population or into our health systems. Overall, Canadian funding is low, but its distribution is skewed.

The type of research that is critical to bridging any discovery into practice is a clinical trial. This is where you formally test the impact of treatments on human health—the kind of thing that Dr. Fowke would like to do next.

In the U.S., 11% of the NIH budget is spent on clinical trials. In the U.K., they have two bodies: one body called the U.K. MRC, and the other called the U.K. National Institute for Health Research. The latter is for clinical population research. Of that, each one was about a billion pounds when it was started five years back.

In the NIHR in the U.K., 20% to 25% of its budget, or 10% of the national budget, is spent on clinical trials.

[The Chair, Liberal, Bill Casey]

Dr. Yusuf, I have to ask you to wind up your 10 minutes. You're a little over that, and we want to get to questions and the other guests.

I hate to do this because your information is very helpful and very clear, but we need you to wind up.

[Dr. Salim Yusuf]

Okay.

Well, the point I want to make is that in Canada, we only spend 3.3% as opposed to 10% or 11%.

I'll wind up with one point: What is needed in Canada?

We need to increase funding for all forms of health research right across the board. Importantly, we need to redress the imbalance so that clinical population research is funded, and eventually basic biomedical and clinical and population research are equally funded. Ultimately, this may only be possible by creating a new structure, one that includes the current CIHR, and then an expanded vision, as has been done in the U.K. with the NIHR, where a similar amount was provided for translational clinic population and health systems research.

I'll stop there.

Thank you very much.

[The Chair, Liberal, Bill Casey]

Thank you very much.

Now we'll move to Genome Canada and Mr. LePage

[Marc LePage, President and Chief Executive Officer, Genome Canada]

Thank you, Mr. Chairman.

Good morning. Thank you for the opportunity to speak to you today.

I'm joined by my colleague Dr. Cindy Bell, who is our senior VP of Corporate Development and one of the founders of Genome Canada.

I'll make a few comments in French and English, so if you need your earpieces, this is fair warning.

Good morning, Mr. Chair.

We are going to talk to you about our industry, genomics, and the importance of health research in Canada.

Identifying which technologies to promote and nurture means understanding rapidly evolving science, assessing their potential and deciding which show the most promise. For governments, it means providing the environment and funding to enable researchers to keep at the leading edge. It also means shouldering part of the risk of helping discovery develop into transformative products.

Artificial intelligence, quantum computing and synthetic biology are some of the fields attracting attention.

Genomics is one of those transformative technologies, and it is driving innovation in health care today. However, as the Barton panel on economic growth confirmed, it is just as critical to other important areas for Canada: agriculture, fisheries, forestry, the environment, and even the mining and the oil and gas sectors. It has become the enabling technology for the bioeconomy.

The bioeconomy is at the core of Canada's economic past, present and, more importantly, future. Because of our enormous natural endowment, Canada has built world-leading industries in the agricultural food sector, in fisheries, in aquaculture and in forestry. If we add the public and private investments in health care, Canada is probably the most biologically centred economy of all of the OECD.

Genomics unlocks the genetic code, the operating software for the living world. To maintain and grow our natural advantage and to continue to expand our exports, Canada must continue to be a leader in the fundamental technology that drives biological systems. We can't be first rate on production and third rate on technology.

That's why we're here. Genome Canada was created by the scientific community with the support of the granting councils as an independent organization dedicated to harnessing its transformative power and accelerating the uptake into industry and public service.

Health is our single largest sector. About 50% of our funding goes to the health sector, but—usually people are fairly surprised by this—the other 50% goes to agriculture, the environmental sector and natural resources.

We're a specialist agency. We provide strategic funding, direction, management and oversight. We focus on large-scale research projects. We also convene coalitions of interested parties around shared challenges and opportunities.

We should note that the Canadian effort is best described as a national initiative rather than a federal one. While the federal government clearly led the parade on funding as first investor and 45% of our research funding is from the federal government now, 55% is from other partners: the provinces, industry, and Canadian and international foundations.

We are also deeply rooted in the regions, working in a collaborative network with six regional genome centres: Genome British Columbia, Genome Alberta, Genome Prairie, Ontario Genomics, Génome Québec and Genome Atlantic. It is very decentralized, just like Canada. It reflects our federal-provincial arrangement.

Genome Canada's mandate has evolved from the early days of genomics, when sequencing the complete gene set of a single organism was a monumental achievement, to today when scientists read hundreds or thousands of genomes during a project.

Nowhere is this more true than in health care and medicine, where genomics is driving a revolution called precision health or personalized medicine. The central idea is simple: each and every one of us has a very precise and differentiated genetic signature and our susceptibility to disease or how we respond to drugs varies from individual to individual based on this genetic signature.

Countries around the world are rushing to embrace the potential of these new tools. Just this month the U.K. minister of health announced an ambitious plan to sequence five million patients as part of a national precision health initiative. The United States has launched a $1.5-billion program to sequence one million Americans and combine that data with electronic health records. France, Australia and China all have ambitious national programs.

In Canada, we have launched a national initiative to implement precision health. Phase one of this initiative is actually focusing on rare diseases—a subject of interest to this committee, I think—and genetic disorders that impact roughly one million Canadians, mostly children. These diseases are notoriously difficult to diagnose and to treat. Building on Canada's strength in rare disease research and a wonderful regional children's hospital network, this pilot initiative will establish shared and effective policies, processes and technologies to establish a national system for Canadians.

The program will consist of three parts.

The first part is the establishment of a national rare disease cohort with 30,000 genomic samples from patients and their families. This will be matched with clinical data.

The second part is a national platform for data standards, consent forms and governance, working with the provinces so that we can aggregate provincial data.

The third part will be the establishment of regional sites that are linked together nationally to provide diagnostics across the country.

This project builds on the world-leading research led by investigators here in Ottawa at CHEO by collaborating with 21 other sites across the country through a program called Care for Rare. This team has so far identified 82 novel rare diseases—very high productivity—and has provided definitive diagnoses to over 1,000 patients who have been spared the long diagnostic odyssey. They continue to work with colleagues around the world to understand other rare diseases and to develop therapies to help these patients.

Dr. Aled Edwards and his colleagues will speak to the issue of developing affordable therapies for rare disease patients, which is one of our very innovative funded projects. We'll come back to that in a second.

I'll finish with a few words about the future for Genome Canada. We are scheduled for review and renewal of our funding in March 2019, so it's just around the corner. We have presented a strategic plan in our pre-budget submission that sets out a vision for Canada to be a world leader in biotechnology and the bioeconomy. We have requested continued federal support through a five-year contribution of $630 million from the federal government. This would be matched with partner funding of $680 million from the provinces, industry and our usual funding partners around the world.

This will drive discovery, translation and personalized health care for rare diseases. Over time it will roll into cancer, cardiovascular disease, pharmacogenomics and a number of areas that will be phased in as we move through this whole process.

It will also drive growth in agriculture, adaptation, fisheries and important resource industries from coast to coast to coast. We have a number of projects in the Arctic and around the boreal forest.

We respectfully request that the federal government consider our pre-budget submission to help ensure that Canada remains a world leader in the field of genomics research.

In closing, prior to being asked to come to the committee, we had organized Genomics on the Hill for next week, a public event right next to the House of Commons, where a number of these researchers I spoke of will be presenting their projects across the whole portfolio of health, agriculture and natural resources. I think you've all received invitations, but if you've lost yours, I have some spares, so I hope to see you again next week.

Thank you very much.

[The Chair, Liberal, Bill Casey]

Thank you very much.

Now we go to Structural Genomics Consortium. I believe Dr. Edwards will open for 10 minutes.

[Dr. Aled Edwards, Chief Executive Officer, Structural Genomics Consortium]

Thanks for having us. I guess it's your day of listening to geeks.

I'm a professor at the U of T, Oxford and McGill, and an entrepreneur who has founded several companies, among which is Affinium Pharmaceuticals, whose new antibiotic is in late phase II clinical trials. When we sold it, it provided excellent returns for investors when it was bought by a Swiss company.

Today I'm speaking in my capacity as a chief executive of the Structural Genomics Consortium. It's a hard word, so let's call it SGC. It's a global charitable research company headquartered in Toronto, with labs in six different countries. I'm also the chair of the board of M4K Pharma, a Toronto drug discovery company I'll tell you about.

My colleague here, Max Morgan, is a patent lawyer by training who practised in the private sector in America and Canada and joined us recently as the lead in legal matters and policy.

I doubt you know about the SGC, but we're the largest, longest-running and arguably most successful global public-private partnership with the pharmaceutical sector. We carry out fundamental research at our labs, and over the years we have attracted about $400 million in funding for our science. About $200 million comes from 10 different pharmaceutical companies.

What's most interesting from the policy point of view is that despite our intense collaboration with global pharma, we never, ever file for patents. All of our funders, including the industry, believe that the fundamental science we do will have the most scientific and economic impact if made openly available to all, as so-called open science.

Indeed, the success of our organization has led us to be considered global pioneers in biomedical open science. Max and I advise governments and foundations all around the world on how open science can not only promote discoveries but can stimulate economic growth.

I'd like to mention that Genome Canada has funded us continuously since 2003—one of our many funders—and has played a central role in developing and honing this open-science business model.

I'm not here to preen about what we've accomplished but rather to humbly admit we need to do much, much better. As members of the global biomedical research community, our aim is to develop innovative treatments of the diseases that afflict society, and we're not delivering. Globally, despite literally trillions of dollars of public funding over the past decades and an equal amount of private sector funding, we are inventing too few new medicines. What's worse, those medicines we invent are priced at levels that will cripple our health care system and are unaffordable to most people on the planet. Something is not right, obviously.

I know that the Canadian government is desperately looking for ways to help, but I also appreciate the inherent conflict you're in. On the one hand, Industry Canada's or ISED's role is to help develop policies that promote economic growth, and if we create biotech companies that create new medicines, it's viewed as a success. As much as ISED is happy about this, Canadians are less so, because in our sector, business success is predicated on high drug prices. Simply put, the big policy problem is that if public funding supports and buys into the current business and investment models used to incentivize drug discovery, we may get new medicines, but they'll be priced unaffordably. It's nobody's fault; it's just the business model on which the world currently operates, and currently there's no option.

Will advances in science help? Sure, but not as much as we hope. As Marc told you about personalized or precision medicine, it's fantastic science. In the long run, it will be awesome, but in the short term, it's going to make things worse. Let's explain.

The brilliant genetic work by CIHR- and Genome Canada-funded researchers all over the country is disassembling all complex diseases into a range of precise genetic smaller diseases. Diabetes, for example, was one or two diseases. Now it's going to be dozens of rare diseases that should be able, in theory, to be treated more precisely, more individually.

However, think about it. From a business perspective, this means that the immense, uniform diabetes market is being fragmented into smaller markets, and each is a group that needs its own new medicines. Unfortunately, as the patient groups and markets get smaller, the cost of inventing a medicine has stayed the same. If you have costs that are the same and the market is smaller, the only way to get your required return on investment is to set the drug prices higher. It's simple math. Now with new medicines being priced at literally hundreds of thousands of dollars a year, that simple math is going to bankrupt us.

What do we do? In our organization over the last 15 years, we've shown that open science provides the most cost-effective way to carry out fundamental research of relevance to drug discovery, and it delivers the science goods, and we'll talk about that. Moreover, it has the buy-in from industry. Why can't the model be extended all the way from the science we do to the registration of new drugs?

Max and I decided to try to figure out how. We looked at how to create a made-in-Canada business model to invent new but affordable medicines, a business model that creates companies to make a profit but not an exorbitant profit, and a business model that balances the tension between economic growth and societal benefit. In short, we wanted a drug discovery model that I hope you think is Canadian, and I think we've done it.

At its core, our model is based on two principles. First, it extends and leverages the expertise we have in open science and applies these learnings to drug discovery. We believe that open science uniquely provides a way to ensure that any public investment in research and drug discovery is used not only to develop new affordable medicines but also to increase science knowledge in the public domain.

Second, the open science model more efficiently uses existing biomedical research funding. As Salim was saying, Canada alone spends $5 billion each year supporting biomedical research, mostly at our universities and hospitals, and the world invests about $300 billion in biomedical research in companies and in the public sector.

I put it to you that there's a lot of money around, and I'm not here to ask you for more. The open science model provides a mechanism to tap into, focus, and align existing sources of capital, including public funds, towards a public-good business objective.

You might be thinking that I'm a hippie, that I'm smoking something...or at least tomorrow, maybe. If a company makes its science and research available, how can it protect itself against competition? When Max was doing his graduate work at Harvard, studying intellectual property law and drug discovery, he thought deeply about this and how one could cleverly use protections that are already provided by regulators like Health Canada—not patents: you don't need patents to stave off competition—and about the advantages of this approach.

When we started working together, we realized that this alternative form of market protection is consistent with open science. If you follow a patent strategy, you can't share it. If you follow this strategy, you can share it and get all the benefits of it.

We thought, wow, this new drug-discovery model just uses existing laws in new ways. We can get the scientific, social, and economic advantages of open science and yet still be able to fend off competitors in the marketplace.

We formed M4K Pharma to test the ideas. M4K stands for Meds for Kids, and it was formed to invent medicines for rare pediatric diseases. The first project is diffuse intrinsic pontine glioma, which is a brain cancer in the brain stem. You can't operate, and all of the children die—all of them. There are no drugs for the disease. The market is too small for the traditional business model.

As background, this science story is also cool. It starts with the work of genius clinician scientists in Montreal and Toronto, who, with public funding, in part from Genome Canada, discovered the genetic makeup of that cancer and uncovered a gene that's the cancer's Achilles heel. In an fortunate twist of fate, Alex Bullock, who is a prof at our lab in Oxford, happened to be the world expert in that gene. It's a really cool test case for the business model. We have sick children with no treatment, a disease that's not attracting interest, and a team of world experts who are our friends and are committed to the public good.

We started it, and it's going better than we hoped. Based on the science and a competition—we shouldn't get money for free—we got public funding from the Ontario Institute for Cancer Research. We matched their $2-million grant with donations and corporate in-kind contributions, giving us another $2 million. Consistent with open science, we share our most recent science every month on WebEx for anyone who wants to listen.

As a result, the scientific community is responding in kind. Last month a doctor from Washington, D.C., offered to do some experiments for the company for free. Scientists in Barcelona and Philadelphia offered advice and also resources. In May, there was a stunning presentation from Boehringer Ingelheim, which is a large pharma in Vienna, where their cancer group is. They called in and told us what they'd discovered internally about the gene and highlighted things we should watch out for.

Think of that. It's a large pharma phoning a competitor drug-discovery organization and letting them know their trade secrets. It's all because we're doing it openly and sharing our science. I think we're only just learning the competitive advantages of this open model. There are undoubtedly surprises to come. Indeed, we're so encouraged that we're starting the process of forming M4ND, Medicines for Neurodegeneration, such as Parkinson's, and M4ID, Medicines for Infectious Disease, such as antibiotic-resistant bacteria.

How can the government help? We're not here for new funding, but I think it would go faster and the model would attract more interest with a few policy changes to incentivize like-minded entrepreneurs.

The first thing we suggest is to tweak existing government funding programs to allow applications from folks with alternative business models. There's a monolithic position in Canada, and frankly all over the world, that patents are key to making new medicines. This is patently untrue, as it were.

Policy suggestion number one is that government and public funding programs should embrace business models with innovative strategies to bring products to patients.

Policy suggestion number two is that we should tweak Health Canada's regulatory protection scheme to provide additional incentive for companies that commit to open science and affordable pricing, the two of them. If a company shares its science and agrees to make the product affordable, Canada should find ways to encourage that.

My last policy suggestion is we should—and I absolutely agree with the previous speakers—continue to support research in the public domain, such as the research supported by CIHR and Genome Canada. Fundamental research provides the foundation on which all medicines will eventually be discovered.

Thank you.

[The Chair, Liberal, Bill Casey]

What a great panel. Often we don't know where these studies are going to go, but every one of you is so impressive. You bring so much to the table.

We're going to start our seven-minute round of questioning with Dr. Eyolfson.

[Doug Eyolfson, Liberal, Charleswood—St. James—Assiniboia—Headingley, MB]

Thank you, Mr. Chair.

Thank you all for coming.

My only regret about this morning's panel is we don't have more time to talk to all of you. This is fascinating.

I'm one of the fellow geeks. I'm a physician myself. I've done some medical research before that. Much of this is familiar to me and is part of the reason that I'm now in this strange line of work.

Dr. Edwards, I want to clarify something first. You said that your organization doesn't apply for patents but that there is protection of the property. What is to prevent something that you develop from then being patented by somebody else and then being restricted by those who patent it?

[Dr. Aled Edwards]

The rules of patenting are that you may not patent something that has been prior art or in the public domain. Our organization rapidly puts things out there, and that prevents people from patenting and lets everybody use it all around the world.

[Doug Eyolfson, Liberal, Charleswood—St. James—Assiniboia—Headingley, MB]

Thank you. That's very good to know, and a very worthwhile effort and philosophy. Thank you for promoting this approach.

This question is for Dr. Fowke. I'm a graduate of the University of Manitoba, so thank you for coming. We talked about the different steps of research. When you find a new drug, you have the biomedical discovery. You find this molecule. It does this, and it could be useful, but developing it into a drug requires the very expensive process of a randomized clinical trial, which is to somewhat allude to what Dr. Yusuf had said about population-based research.

I know you were talking about something different, Dr. Yusuf, when you said population-based research, but it involves very large populations. We understand that pharmaceutical companies are doing this research, and they want patents because they want a protection for all this money they spent.

If these randomized clinical trials were, in fact, performed or funded through public agencies, would this then take the burden off these companies that produced them to recoup the losses of development and lead to lower drug prices? Is there that potential if the public is funding the randomized clinical trials?

[Dr. Keith Fowke]

Yes. Thanks for the question.

I think that's very much the case. There are several barriers for moving new ideas to translation into patients. The clinical trial just costs so much money, so I do think there would be significant advantages if there were some mechanism to fund those clinical trials other than the individual companies funding them themselves, or in our case an individual investigator trying to fund them. Individual investigators might have good ideas, but to do a 10,000-person clinical trial is unrealistic. Some support mechanisms to perform those trials would reduce barriers for sure.

[Doug Eyolfson, Liberal, Charleswood—St. James—Assiniboia—Headingley, MB]

All right. Thank you.

This is a very difficult question, and I'll throw it out to everybody. By what percentage would we have to increase our medical research funding to allow the public sphere to be doing this research, based on Canadian or even worldwide national funding levels?

I'll start with you, Dr. Fowke. Do you have any idea what this would be?

I'm sorry, Dr. Fowke, did you hear my question?

[Dr. Keith Fowke]

No, sorry. Could you repeat that?

[Doug Eyolfson, Liberal, Charleswood—St. James—Assiniboia—Headingley, MB]

By about what percentage would you say countries would have to increase their medical research funding levels to do the kind of research that's currently being done by industry?

[Dr. Keith Fowke]

To be honest, I don't know that answer. Again, having more focus in the modelling would be appropriate, but I don't have a number.