Health Committee on Nov. 2nd, 2010

[The Chair, Conservative, Joy Smith]

Good morning, ladies and gentlemen. Welcome to the Standing Committee on Health. Pursuant to Standing Order 108(2), the topic today is the study of stem cell donation in Canada.

I'm very pleased today that we are going to be listening to our witnesses talk about stem cell donation in Canada.

We have witnesses from the Canadian Stem Cell Foundation. I want to welcome you. I'm Joy Smith, the chair of this standing committee, and I welcome you to our committee. I think I've met a couple of you recently.

We have Dr. Drew Lyall, chair, board of directors of the Canadian Stem Cell Foundation. Welcome, Dr. Lyall. I'm glad you're here.

From the Hospital for Sick Children, we have Dr. Janet Rossant, chief of research. Welcome.

From the Stem Cell Network, we have Dr. Michael Rudnicki, scientific director. Welcome, too.

Joining us by video conference, from Winnipeg, Manitoba, we have some guests. I'm very happy they've been able to take the time to join us today. First of all, I'd like you to meet Dr. Dhaliwal, president and chief executive officer and the provincial clinical director of oncology.

Welcome, Dr. Dhaliwal. It's nice to see you this morning.

[Dr. Dhali Dhaliwal, President and Chief Executive Officer, Provincial Clinical Director of Oncology, CancerCare Manitoba]

Good morning.

[The Chair, Conservative, Joy Smith]

Can you hear me well?

[Dr. Dhali Dhaliwal]

Yes, thank you.

[The Chair, Conservative, Joy Smith]

Secondly, we have Dr. Geoff Hicks, director of regenerative medicine, University of Manitoba, senior scientist, Manitoba Institute of Cell Biology.

Welcome, Dr. Hicks.

[Dr. Geoff Hicks, Director of Regenerative Medicine, University of Manitoba, Senior Scientist, Manitoba Institute of Cell Biology, CancerCare Manitoba]

Thank you. Good morning.

[The Chair, Conservative, Joy Smith]

We have Dr. Donna Wall, physician, pediatric hematology and oncology. Welcome, Dr. Wall. It's nice to see you.

We also have Dr. Spencer Gibson, provincial director of research. We're very happy you're going to be here as well.

Today we have presentations, 10 minutes each, from each of our organizations.

Dr. Dhaliwal, when we go to the video conferencing, will you be the lead with the group of people there?

[Dr. Dhali Dhaliwal]

Yes.

[The Chair, Conservative, Joy Smith]

That's fine, then.

How it proceeds is that we will begin with 10-minute presentations from each of our guests. Following that, we go into two rounds of questioning.

As you know, the health committee is made up of all parties across our great nation, and each one of those parties has questions they want to ask.

Are you set to go?

We'll start first with Dr. Michael Rudnicki, from the Stem Cell Network.

Dr. Rudnicki.

[Dr. Michael Rudnicki, Scientific Director, Stem Cell Network]

Good morning. Thank you very much for your invitation to testify today.

I'm speaking to you as a Canada research chair, a senior scientist and director of the regenerative medicine program at the Ottawa Hospital, and also as scientific director of the Canadian Stem Cell Network. The Stem Cell Network is funded through the national centres of excellence.

First of all, why is stem cell research important? Stem cell research, first, is an area of true strategic strength scientifically in Canada; and secondly, stem cell research is paving the road for regenerative medicine to enter the clinic. Regenerative medicine is going to transform medical practice by alleviating, or possibly curing, many of the devastating diseases that plague mankind, including cancer, type 1 diabetes, Parkinson's, Alzheimer's, heart disease, strokes, spinal cord injury, and so on. Regenerative medicine will not only transform clinical practice, but it will change the paradigm of health care and the pharmaceutical industry in a very profound way.

These are truly exciting times in stem cell research. It's been over seven years since I last presented to this committee, and in that time a lot has happened.

In the next few minutes I'm going to touch on three different areas where advances have occurred: a new source of stem cells, new ways in which stem cells are being applied in the lab, and some recent examples of clinical trials.

You'll remember that the last time stem cells were debated in the House—not just here but around the world—much attention was paid to the relative merits of adult versus embryonic stem cells. Embryonic stem cells are derived from four-day-old to five-day-old embryos. These embryos have been created for the purpose of in vitro fertilization and they would otherwise be discarded.

[The Chair, Conservative, Joy Smith]

Dr. Rudnicki, may I interrupt you for a minute? You're speaking a little too fast for our interpreters. All conversation is being translated in both languages, so perhaps you could slow down a little bit. Thank you so much.

[Dr. Michael Rudnicki]

I'll slow it down. I'm sorry. It's too much coffee this morning.

Embryonic stem cells are derived from four-day-old to five-day-old embryos. These embryos were created for the purposes of in vitro fertilization and would otherwise have been discarded. These embryonic stem cells have the capacity to generate all possible cell types in the body. Adult stem cells, on the other hand, are more specialized. They reside within tissues and they give rise to a limited spectrum of cell types that are present in that tissue. For example, hematopoietic stem cells only give rise to different types of blood cells. Adult stem cells are found in all of us, in all of our tissues. They are also present in cord blood, amniotic fluid, and possibly the placenta.

The debate around embryonic stem cells has been overtaken by scientific progress. The most significant advance in the stem cell field in the past decade has been the seminal discovery by Shinya Yamanaka, of Kyoto, Japan in 2006, of induced pluripotent stem cells, so-called iPSC. What Yamanaka showed was that you could take any cell in your body--a skin cell from the tip of my nose, for example--and by applying a very simple procedure, introducing four genes into it, reprogram that cell to make it closely resemble in a way that the cell is essentially indistinguishable from an embryonic stem cell. So you can derive an embryonic stem-cell-like cell from any adult cell type. This is a paradigm-shifting discovery, a very, very important advance.

While this has not completely obviated the need to work with embryonic stem cells--we still need to compare and contrast iPSC cells with embryonic stem cells, and research needs to be conducted with human embryonic stem cells--this discovery has really transformed the field.

Seven years ago most of us were thinking about stem cells being used to regenerate replacement cells for transplant purposes for diseased organs, to treat degenerative diseases, and so on. That work still goes on. For example, here at the Ottawa Hospital my colleague Duncan Stewart is undertaking a trial to treat patients with pulmonary hypertension--this is a fatal disease that affects primarily women in their thirties, and it's a lethal disease--where stem cells are derived from the blood, are temporarily modified to contain a gene that stimulates blood vessel growth, and those cells are reintroduced into the circulation.

Another colleague, Harry Atkins, at the Ottawa Hospital has been using bone marrow transplant protocol for the treatment of severe cases of multiple sclerosis. Essentially, what he's doing is curing the autoimmune disease in those patients. It's really quite a phenomenal advance.

In a recent clinical trials workshop held by the Stem Cell Network, we identified over 50 Canadian-based trials involving stem cell therapies, and these will be entering the clinic in the next three to four years. So the field is advancing tremendously fast, much faster than all of us had anticipated.

Advances are being made at a similar pace outside of Canada. As committee members, I'm sure you've read about Geron, a U.S. company that has just initiated a clinical trial whereby spinal cord patients are receiving cells that have been differentiated from human embryonic stem cells, so-called oligodendrocytes, that will be used to treat spinal cord injury. That's just been started and is the first clinical trial using embryonic stem cell-derived material anywhere in the world.

Returning to iPSC cells, Yamanaka's discovery has opened the doors to the rapid and efficient creation of disease-specific stem cells and patient-specific stem cells. This has opened up whole new lines of inquiry and has allowed researchers, for example, to screen these cells against drug libraries. A library of drugs can be thousands and thousands--perhaps even up to one million or so--of compounds that represent all possible classes of chemicals. They can also be a library of drugs that's already in the clinic so they can rapidly move into clinical trials.

I'll give you a couple of examples. My colleague Bill Stanford at the University of Toronto has derived induced pluripotent stem cells from patients with progeria. Progeria is a genetic disease where kids rapidly age. They die at around age 13, resembling 96-year-olds. They die of atherosclerosis; they die of heart attacks and strokes.

He has derived iPSC from those patients and isolated vascular smooth muscle cells--blood vessel cells--from those patients. The remade blood vessel cells start off healthy, but they rapidly age in petri dishes, recapitulating the disease. So he's going to use those cells to screen for drugs that will prevent that aging process. These drugs could be used for the progeria patients, but they could also be used more widely in patients suffering from atherosclerosis.

Another colleague, Lee Rubin at Harvard Medical School, has done a similar procedure with SMA patients. This is a disease where spinal motor neurons die, and kids at a very young age are affected. It's a horrible disease. He screened for drugs that would promote neuron survival. These neurons were differentiated from the iPS cells. He identified drugs, and at least in mice he can treat SMA at this point. So it's a very exciting way to personalize drug screening approaches to identify new drugs that can be used rapidly in the clinic.

Other cell types can also be screened in the same way. Another Stem Cell Network member, David Kaplan at SickKids Research Institute in Toronto, has isolated cancer stem cells from neuroblastoma tumours in kids and screened for drugs. He identified some drugs that killed the tumour-initiating cells, the cancer stem cells. Within two years this has found its way into a compassionate clinical trial at SickKids, and is now in a multi-site trial across Canada and the U.S. It's phenomenal progress. Using the same approach, they're now attacking three other tumour types that cause cancer. It is really quite phenomenal.

Using stem cells to generate replacement cells and identify drug targets are just a couple of ways in which stem cells are transforming medical research. Some groups are using stem cells to better understand the diseases of early development. Other groups are using them to generate large quantities of human cardiac and neural cells to use to test drugs for toxicity before they are ever given to a patient, making clinical trials safer. Many groups are working to derive liver cells for the same purpose.

In short, the field remains exciting and is progressing very rapidly. It's not without challenges. This work is very important. What we're talking about is making changes to clinical practice that are going to help people. It will save lives and alleviate suffering.

At this point I will ask my colleague Drew Lyall to continue.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Rudnicki.

Now we will go to Dr. Lyall. He's the chair of the Canadian Stem Cell Foundation.

[Drew Lyall, Chair, Board of Directors, Canadian Stem Cell Foundation]

Thank you.

For full disclosure, I should also let you know that I'm executive director of the Stem Cell Network. We all wear many hats but hopefully speak with one voice.

I'd like to thank the chair and the committee for inviting the Stem Cell Foundation to present this morning. We're a relatively young organization, and we're delighted to have the opportunity to contribute to these proceedings.

As you heard this morning, stem cell research is beginning to reach the clinic. Even if you exclude bone marrow transplants, which have been around for 40 years and still account, together with umbilical cord work, for more than 95% of all the clinical trials going on around the world, over 350,000 patients have now been treated with approved stem cell products across the globe, for diseases ranging from chronic wound healing to cartilage repair. While treatments for such diseases as Alzheimer's may still be ten, twenty, or thirty years away, treatments for stroke, multiple sclerosis, pulmonary hypertension, heart disease, Crohn's, neuroblastoma, and others are already entering the clinic.

The impact of this really will be profound, in several ways. First and foremost will be the improvement in the quality of life for both patients in Canada and around the world and the families and communities around them.

Second, delivering cures for these chronic degenerative diseases can have a really significant impact on the health care burden in Canada, not just through alleviating the direct costs of treatment but also through returning the patients and the families, to whom their care often falls, to productive lives.

Finally, the development of these new drugs and therapies will actually present a really great opportunity to create new high-level jobs in Canada in the growing regenerative medicine industry.

This is an opportunity that Canada should be capitalizing on, but it's also one that we should be taking great pride in. Stem cells are actually Canada's gift, if you like, to the world. Stem cells were discovered here in Canada. Next year marks the 50th anniversary of when Jim Till and Ernest McCulloch made the discovery at the Princess Margaret Hospital in Toronto.

Over the last 50 years, Canadian scientists have continued to make landmark discoveries in this field. In fact, Canada scientifically is probably as strong as any country in the world. But that leadership and the long-term opportunities that flow from it are somewhat at risk.

Other jurisdictions around the world are recognizing the same opportunity and are investing heavily in the field. The clear benchmark for this is California. What California did three or four years ago was to invest $3 billion to create the California Institute for Regenerative Medicine. That's an investment of $300 million a year over ten years. It represents about ten times the current federal investment in stem cell research, and close to one-third of the entire annual budget of CIHR. Those funds are being used to support the full spectrum of activities needed to move therapies from fundamental research to research and manufacturing facilities, to funding for phase I and II trials, and even to providing non-dilutive capital to start-up companies through loans. In a sense, it's simply not realistic to expect Canada, or indeed anybody else, to keep up and to remain globally competitive in the long term without some further dedicated investment in the field.

Even within the current context of our funding, there are still some challenges. Let me give you a couple of examples.

The utility of cord blood as a treatment for many types of cancers has been well established. In many centres in the United States, cord blood is now used more often than bone marrow transplants in these types of procedures. Here in Canada, the business case for a public cord blood bank has been well made. Not every umbilical cord needs to be banked. Cords from a small but statistically significant subset of the population would provide sufficient genetic variation to cover almost all of the needs.

We understand that discussions have been taking place between the provinces and territories to see if Canadian Blood Services and Héma-Québec could establish a public cord blood bank. In fact, there was a consensus statement around the need to do so in June 2007. But here we are at the end of 2010, there is still no visible progress, and patient needs remain unmet.

Let me give you another example. Just over $80 million of federal, provincial, and philanthropic funding is being invested right now in building three GMP-compliant cell-manufacturing facilities in Toronto, Montreal, and Edmonton. Collectively, these world-class facilities should have enough capacity to accommodate Canada's cell manufacturing needs for the next decade. The clinicians behind those facilities are already working with each other to determine how best to manage these effectively as a virtual national organization. How can we triage requests to the right city? How can we set up standard operating procedures? How can we develop common education programs?

The challenge is that as funding priorities have shifted across federal and provincial governments, it has become less and less clear where the operating costs for these facilities, or the funds to support the associated clinical trials, will come from.

To give an example, it might be necessary to do half a dozen trial runs of creating some cells in the facility before you actually put them into the patient. But that isn't the kind of research the granting councils typically fund; and because it's a clinical trial rather than an approved health care procedure, it's not eligible for provincial health care funding either. So we run the risk of these clinical trials falling into a black hole where no real opportunity for funding exists. The 50 trials mentioned by Dr. Rudnicki earlier in his presentation may never happen in the absence of that funding.

Finally, there are opportunities to improve both the regulation of the research environment and the regulation of therapies, if they move from the lab to the clinic. My colleague Dr. Rossant is going to talk to some of those challenges.

I'd like to wrap up with a plea. Stem cell research is an area in which Canada has pioneered and led the world. We have the talent, the will, and the expertise to continue to do so. I know this committee understands the significant benefits that stem cell research can bring to our health care system. Let's not squander the legacy of Till and McCulloch but make sure that Canadians patients are the first to benefit from their discovery.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Lyle.

We'll now go on to Dr. Janet Rossant.

[Dr. Janet Rossant, Chief of Research, Hospital for Sick Children]

Good morning, and thank you for the opportunity to speak.

I'm an active stem cell scientist and I'm also chief of research at the Hospital for Sick Children, which is one the largest child health research institutes in the world. I am also deputy scientific director of the Stem Cell Network.

My colleagues have spoken about recent progress in stem cell research and its application to the clinic in Canada and worldwide. These really are exciting times for stem cell research. In particular, these new approaches to reprogramming cells from adult tissues into stem cells that regain the potential to make all the cell types of our body--so-called induced pluripotent stem cells, or iPS cells--really have transformed the way we think about studying human disease in a petri dish.

Already the Ontario iPS facility located at SickKids, for example, is taking samples of tissues from patients with developmental disorders such as congenital heart disease, neuro-developmental problems such as Rett syndrome and autism, and lung disorders like cystic fibrosis, and developing banks of patient-specific stem cells, these iPS cells. Then we can take these cells, distribute them to scientists, coax those cells to form the appropriate cell types in the petri dish—heart muscle cells, nerve cells, and lung cells, for those particular diseases--and then study those cells to determine what goes wrong in the disease and then how to fix it with new therapies.

In the future, however, this whole concept of being able to take adult cells and make stem cells, pluripotent cells that make every cell type, gives us the opportunity to think about population-based banks of normal iPS cells that could serve as sources of cells for cell therapy for many different diseases. We're not there yet. The technologies for generating iPS cells and for differentiating them into the right cell types for therapy, such as bone marrow stem cells, nerve cells, etc., are just not efficient enough yet to make such banking worthwhile. But the rapid progress of science here tells us that this will come in the future. And we need to stay on top of the science to be ahead of the opportunities to translate new advances into broadly available stem cell therapies for Canadians.

Science is moving extremely fast in this area, and this, of course, has ongoing implications for the regulatory environment for stem cell research. In Canada, human stem cell research, embryonic stem cell research, and iPS cell research are all governed by three separate regulatory instruments. There's the Assisted Human Reproduction Act, AHRA , the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, the TCPS--we all like these acronyms--and the Canadian Institutes of Health Research's Updated Guidelines for Human Pluripotent Stem Cell Research. So we have the act, the tri-council statement, and CIHR's guidelines.

Of these, only CIHR's guidelines were really established specifically to address the ethical issues of all human pluripotent stem cell research, including the newly developed technologies we've been talking about that do not involve derivation of stem cells directly from human embryos. The CIHR has a stem cell oversight committee that is mandated to provide ethics review across the country of all human pluripotent stem cell research funding applications in CIHR-funded institutions in Canada. The guidelines cover essentially all of the major pluripotent stem cell initiatives that are taking place in Canada in academic institutions. And although they don't have regulatory application, they would have strong moral suasion on any commercial entities that are dealing in this area, most of which have arisen as offshoots of academic programs.

However, at present, the Canadian policy framework is in a bit of a state of flux. The tri-council policy statement is currently being revised by the Interagency Advisory Panel. As well, the constitutionality of several of the provisions of AHRA, the Assisted Human Reproduction Act, have been challenged before the Supreme Court of Canada, and the decision still outstanding. Furthermore, the AHRA is overdue for its mandated parliamentary review, which has the potential to have real impact on the field because of all these recent advances in stem cell research, which were certainly not contemplated by the crafters of the act. Moreover, given that only one regulation, regarding consent, has actually been adopted pursuant to the AHRA since it came into force in 2004, various aspects of the existing legislation do not have the necessary regulations in place.

So we have a lack of clarity regarding the application of present policy frameworks to new and emerging stem cell technologies, and that creates uncertainty for scientists, regulators, funders, and members of the public alike. It also has the potential to have an unintended impact on the advancement of research, for example, by restricting the parameters of permissible research in Canada.

Responding to these challenges in an informed, balanced, and evidence-based manner is crucial to both the continued success of the field of stem cell research--you've heard how strong that field is in Canada--and of course, on the other side, to the maintenance of public support for and trust in this work.

As an example of some of the issues that are unclear in the regulatory environment, definitional ambiguity--a terrible thing--occurs throughout. It creates a significant area of confusion for the application of these different provisions, particularly in the Assisted Human Reproduction Act.

For example, the legislation provides that human reproductive material, which is the basis of the legislation in the act, means a sperm, an egg, or other human cell, or a human gene, and includes any part of them. That's almost everything. If you actually interpret that norm literally, it could be construed in such a broad manner as to include almost any human cell or tissue, including iPS cells, as human reproductive material. Clearly that doesn't make any sense. A cell that you grow in a petri dish is not human reproductive material and cannot be used in human reproduction.

Given that iPS cells don't require the use of the material that we would normally consider as human reproductive material--that is, early embryos, eggs, or sperm--it seems that iPS cell research, unless it itself is being used to create reproductive material, should not be covered by the AHRA. Bringing iPS cell research under the ambit of that act would introduce more policy and regulatory hurdles, further uncertainty, and then potentially impact the growth and direction of the field in Canada.

The CIHR stem cell oversight committee has already considered these issues and has determined that the generation of iPS cells from tissue samples does not require the approval of SCOC, or stem cell oversight committee, because it does not involve the derivation of material from human embryos. It has to go through normal informed consent, but the use of any pluripotent cells that are derived that way would need SCOC oversight.

Interestingly, as the use of stem cells, pluripotent and otherwise, moves towards the clinic, I think the regulatory environment is actually clearer about their use in the clinic than it is about their research uses. Any cell-based therapy that requires extensive growth of cells outside of the body would fall under Health Canada regulation or the Food and Drug Administration in the United States. The extensive safety and efficacy data that is required before any new therapy can be introduced in clinical trials and eventually to market would be no different for stem cells than any other therapy. No special regulation is required, but the regulatory barrier for the application of stem cell trials, as was seen for the Geron embryonic stem cell trial for spinal cord injury, is appropriately high and should remain high.

The policy development committee of the Canadian Stem Cell Network, of which I am co-chair with Dr. Bartha Knoppers, who has probably appeared before this committee many times, is developing a policy statement on these issues around the advances in stem cell research and the regulatory environment. We propose the following overriding principles for regulation in the area of stem cell research and its application.

First of all, recognize the continued importance for ongoing scientific input into law and policy making in order to foster informed decision-making; encourage respect for scientific freedom while ensuring that any limitations that are placed on the research are justified in a free and democratic society; and promote the use of clear and transparent principles in regulatory frameworks, which should be harmonized across all regulatory instruments, against which new developments in research can be evaluated.

So these are exciting times, there are challenges, and I think the scientists, the regulators, the ethicists, and the clinicians need to work together.

Thank you.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Rossant.

We'll now go to our video conference from Winnipeg, Manitoba, from CancerCare Manitoba.

Welcome, Dr. Dhaliwal. Can you begin your presentation, please?

[Dr. Dhali Dhaliwal]

Thank you.

I want to thank the chair for the invitation to present before this committee.

My group represents CancerCare Manitoba, a provincial cancer agency, and the regenerative medicine program at the University of Manitoba.

As the fourth presenter, forgive me if I repeat some of the comments that have been made, but it will re-emphasize the unity of feeling, and I hope it gives you some idea of the need for across-the-country infrastructure and expertise development.

We are using the definition of stem cells the same way other researchers have used it here, and are not focusing on hematopoietic stem cells.

The University of Manitoba and CancerCare Manitoba, together with local, provincial, and federal partners, have identified stem cells as a strategic research priority. As a result, the university has established a dedicated regenerative medicine program, appointing Dr. Geoff Hicks as the director. Major sources have been mobilized regionally for this effort, but I realize that in the context we're talking about, such as the California investment, this must seem a very small amount. For us it's a substantial effort that includes newly designed laboratory space of nearly 25,000 square feet, six tenure-track faculty positions, two of which are Canada research chairs, and major equipment infrastructure, including flow cytometry and stem cell culture facilities, as well as access to the Faculty of Medicine's transgenic, genomic, proteomic, and bioinformatics platforms.

The vision, as we've heard, is to pursue discoveries in stem cell biology and to facilitate their translation into the clinic. The program is well aligned with major research strengths at our institution in cardiovascular disease, cancer, neurodegenerative disease, and so on.

This infrastructure support occurred, I may emphasize, at a time marked by limited new resources, which reflects the strategic priority our organizations have placed on this. As we have heard, we are at a stage that could radically change the way we treat a wide variety of diseases, including cancer, which we believe, for many of the malignancies we treat, is driven by cancer stem cells. However, all parts of the body depend on some form of self-renewal, and stem cells are at the heart of that process.

As we've heard, we're at the doorstep of rethinking how we manage a wide variety of chronic and major diseases: developmental defects, congenital heart disease, spinal cord injury, and all the other diseases we have heard about.

I'm delighted that we are part of that network, in which Canada is at the forefront, for stem cell research. But as we heard, we need to maintain that impetus by developing capacity across the country. There is a need to support the private sector to move these discoveries into the market and provide the high-tech jobs we've heard about.

But times are changing, and Canadians' expectations of the health care system are changing very rapidly. We've seen elements of that, because families, as they cope with the devastating effects of brain injury from birth insult, and degenerative loss of function from Alzheimer's, multiple sclerosis, and so on, are seeing that all of these are potentially treatable with stem cell therapy, and patients are desperate for new treatments. As a result, more and more Canadians are seeking treatment at foreign medical tourism destinations, or will seek such treatment in the future if we do not step up to the plate and develop that capacity to offer therapies across the country.

We need the infrastructure that we heard about, including regulatory bodies, so that we are in a position to rapidly translate these technologies into the clinical use.

We believe these therapies will create personal, financial, medical, and government crises if we do not proceed with a transparent and comprehensive program and framework to bring these studies into clinical use. That will require the support of basic and translational research across the Canadian health spectrum.

We must be prepared to rapidly bring these technologies through well-designed clinical trials that cover all phases of treatment and development, including not only the early phase trials that test safety and demonstrate efficacy, but also large multi-centre trials that are well designed to address the need for the new treatments and how they improve outcomes and replace standard treatment.

We must be prepared to monitor, in a new way, for unexpected side effects that could occur years later. All along the way there will be observations that need to be taken back to the laboratory for further investigation, and it is critical to have, across Canada, a robust pool of clinical scientists.

There needs to be flexibility in funding to support laboratory studies driven by clinical observations, in a timely manner. In tandem with basic and clinical research, new research initiatives into ethics, cost effectiveness, and the utility of these treatments will be necessary.

We know that clinical trials are expensive and difficult to mount at the level that we are discussing here. So we will have to bolster existing networks, such as the National Cancer Institute clinical trials network, and develop this capacity right across the country so that we can apply what we have heard will be paradigm-changing.

Dr. Rossant talked about the regulatory issues, so I will not address them.

National health care policy planners and provincial health care programs must work with researchers to ensure that financial and infrastructure supports are in place to take these discoveries into routine care. Special laboratories and facilities will be necessary.

Our greatest challenge is really to meet the expectations of Canadians to provide treatments, and even cures, for currently untreatable diseases. I believe building capacity right across the country will be absolutely essential to prevent inequalities in access to these new and exciting and innovative treatments.

Thank you.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Dhaliwal.

Do you have a written presentation you could submit to the clerk?

[Dr. Dhali Dhaliwal]

Yes, absolutely.

[The Chair, Conservative, Joy Smith]

Thank you. We'll get the clerk to translate it into French and distribute it to our committee members.

Now we'll go into our first seven-minute round of questions and answers. Starting with the Liberal member, there's going to be a sharing of time with Mr. Dosanjh and Dr. Duncan. They will ask questions and within the seven minutes, you will have time to answer them.

Who wants to begin here?

Mr. Dosanjh.

[Ujjal Dosanjh, Liberal, Vancouver South, BC]

Thank you.

Thank you to all for speaking to us.

I have a very brief question. I understand the issue is largely a question of resources and a question of money. I'm not a scientist, so I'll focus on the money and the law.

Dr. Lyall, you raised the issue of the cord blood bank. You said there's been a proposal floating around for some time. What stands in the way of that being established, other than money? Money I recognize. Is there anything else that stands in the way?

[The Chair, Conservative, Joy Smith]

Dr. Lyall.

[Drew Lyall]

I don't know if I'm the best-placed person to answer the question--

[Ujjal Dosanjh, Liberal, Vancouver South, BC]

Point it to someone else on the panel, then.