HEAL Committee Meeting

STANDING COMMITTEE ON HEALTH

COMITÉ PERMANENT DE LA SANTÉ

EVIDENCE

[Recorded by Electronic Apparatus]

Thursday, September 27, 2001

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[English]

The Chair (Ms. Bonnie Brown (Oakville, Lib.)): Good morning, ladies and gentlemen. I'd like to call this meeting to order, please.

We have quite a large set of witnesses, so I'd like to begin the testimony right away. I will begin by asking Mary Jardine of Parkinson Society Canada to begin.

Ms. Mary Jardine (National Executive Director, Parkinson Society Canada): Thank you and good morning.

Madam Chair, members of the Standing Committee on Health, ladies and gentlemen, on behalf of 100,000 Canadians who live with Parkinson's disease, David Simmonds, our national chair, and I, as national executive director of Parkinson Society Canada, thank you for inviting us here today. We are going to share this presentation.

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We thank you for considering the views of Canadians with Parkinson's and their loved ones in your deliberations pertaining to the draft legislation tabled last May. We represent the Parkinson family: patients, their families and loved ones, caregivers, physicians, allied professionals, thousands of volunteers, and of course our researchers.

We strongly believe public debate on this issue is crucial. Parkinson Society Canada is a national health charity with regional partners from coast to coast. We share a collective vision to ease the burden and find a cure for Parkinson's through advocacy, education, research, and support services to improve the quality of life for all those who are affected by Parkinson's.

Parkinson's disease is the second-most common neuro-degenerative disorder, next to Alzheimer's. It is a chronic, slowly progressive disease that generally affects a small area of cells in the mid-brain known as the substantia nigra, and most often, although not always, affects people in the latter half of life, with symptoms such as tremor, muscle rigidity, slowness of movement, impaired speech, and difficulty with balance, walking, and fine movements.

After considerable cross-Canada consultation with Parkinson Society's constituents, our national board formally approved a motion to support the seven draft recommendations outlined in CIHR's discussion paper, Human Stem Cell Research: Opportunities for Health and Ethical Perspectives.

In addition, we endorse the draft legislation, especially as it pertains to the use of human embryonic stem cells in health research. The draft legislation mirrors the CIHR recommendations. We have encouraged regional organizations and numerous individuals across Canada to respond to both CIHR's and Health Canada's request for input. Stem cell research holds untold potential for the treatment of Parkinson's. It offers the opportunity for significant progress and benefits in both drug design and testing and in the search for the cause of and a cure for Parkinson's.

Stem cell research offers hope to the 100,000 Canadians with Parkinson's for arresting or reversing the illness. For all those affected by Parkinson's, hope is a crucial element of coping and, indirectly, of cost control. We recognize that there is great potential in the use of adult stem cells in research and we look forward to ongoing developments in this area.

We believe, too, it is very important that adult and embryonic stem cell research are both supported. Progress and discovery will undoubtedly occur at a more rapid pace in the context of diversified research. We support the delineation of permissible limits of research using human embryos, based on ethical principles and the protection of such research under a legislative scheme. We are satisfied that there is such an ethical basis under the proposed legislation.

Canada has some of the most promising and brilliant researchers into Parkinson's disease in the world. The proposed legislation will provide the guidelines and parameters that they have all been looking for. There is no doubt that Canadian researchers will be leaders in this area once the rules are clarified.

Canadians with Parkinson's dream of a healthier, happier future free of the hardships that this disease imposes upon them. The use of human embryonic stem cells and research offers them more than a glimmer of hope that these dreams may one day be a reality.

Mr. David Simmonds (Chair, Parkinson Society Canada): Thank you, Madam Chairman.

Parkinson Society Canada, as my colleague has mentioned, supports the stem cell research being conducted within a legislative context and proceeding from a set of ethical principles. We think that the proposed legislation creates a broad enough framework within which to permit the presently foreseeable scope of stem cell research.

But we are concerned that as research progresses the committee may have to examine the boundaries of permissible stem cell research to make sure that they're not unduly restrictive. It is important that a legislative scheme be developed that contains sufficient flexibility to adapt to changes in research. I know my friends from the Muscular Dystrophy Association will be speaking to that subject in more detail in their brief.

Parkinson's disease is a progressively debilitating illness, both physically and cognitively, and as the expression goes, the trouble with Parkinson's is that it only gets worse. Medication works to alleviate the symptoms, but doesn't retard or cure the disease. Stem cell research offers the possibility of brain repair, a treatment option that might be effective while we still look for the cause of Parkinson's disease. That's why it's caused such excitement within the Parkinson patient community.

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As Ms. Jardine mentioned, the key to thriving with this illness is hope. Hope comes from knowing that no stone is unturned in the research effort. That hope can quickly be extinguished if the research water can't flow where it would otherwise naturally seek to flow. That's why we think the importance must be attached to the flexibility within the legislation and allowing the scientific impetus to continue where it would flow.

There are a couple of other brief points I would like to make. The first is that there is a public cost issue. People affected with Parkinson's, such as myself and Mr. Michael J. Fox, can be diagnosed as early as their late thirties. There are approximately 100,000 Canadians at any one time with Parkinson's, of whom 10,000 or so are under 40. The cost to society of keeping people like myself and Mr. Fox going as the illness gradually debilitates is staggering in terms of lost productivity in the workforce; a disability industry to pay us benefits and keep us honest; the medical services to treat us; the care services to care for us; and the cost and strains on our families and relatives. So an investment in permitting all avenues to lead to a treatment and a cure is quickly worthwhile from a social dividend standpoint.

As representative Canadians living with Parkinson's, we feel we have a duty not only to our existing clientele but also to our children, especially with genetic causes living so large, and to those 100,000 Canadians of the next generation of Parkinsonians who will surely develop this illness unless we are doing all that we can to spare them that burden.

I commend you on your work. I wish you well in the work. And we look forward to participating in the debate on a continuing basis.

Thank you very much.

The Chair: Thank you, Mr. Simmonds.

We'll move now to the Ottawa Health Research Institute with Mr. Ronald Worton, who is the chief executive officer.

Mr. Worton.

Dr. Ronald Worton (Chief Executive Officer and Director, Ottawa Health Research Institute): Thank you. It's a pleasure to be here.

I first want to thank the committee for the opportunity to present our views on stem cell research and the draft legislation on human reproductive technologies.

My comments today are confined to that portion of the act that deals with stem cells. That's our particular interest. And I think it's one of the most interesting and challenging areas of research that's dealt with in the bill. Although it doesn't specifically talk about stem cells, clearly the implications for stem cell research are in many paragraphs throughout the bill.

I wanted you to note that I'm speaking for myself and I'm not officially representing a large group of scientists or any particular group. But I think my views are probably pretty mainstream amongst scientists and you'll hear some of those views echoed from Michael Rudnicki in a few moments.

In a nutshell, I am certainly in favour of this legislation. I think it's timely. It is good legislation overall. And the intent of the bill will allow us to do the kinds of research that need to be done utilizing stem cells and developing potential stem cell therapeutic approaches.

Overall I find the legislation to be balanced, allowing this experimentation to occur but at the same time recognizing the need for scientists, including myself, to work within a legislative framework that is clear and specific.

I will, in a few moments, ask the committee to consider carefully, however, what needs to be regulated versus what needs to be legislated, because one of our main concerns is that something that is in the forbidden category and is therefore illegal will be very difficult to change. We know that research advances over the years, people's opinions change, and we'll be able to do things in 10 years from now that we won't be able to do today. We would like to see some flexibility in this bill.

I thought maybe part of my role today should be to introduce what are stem cells. I suspect, though, that you've all read a fair bit, so I'll try to keep my remarks simple and short.

Really there are two kinds of stem cells, adult stem cells and embryonic stem cells. And a lot of the discussion revolves around the use of embryonic stem cells.

Adult stem cells are unspecialized cells that are capable of doing two things: they can divide and make two cells, and then four and then eight and then sixteen. In other words, they can undergo self-renewal and make more of themselves.

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But they can also do a process that scientists call “differentiation”. They differentiate to create various cell types. I give two examples in my handwritten statement. In the blood, for example, red blood cells carry oxygen, and white blood cells fight infections. Both cell types come from a hematopoietic stem cell, which resides largely in the bone marrow and produces a constant supply of blood cells. Those blood cells have to be renewed constantly.

Skin is another tissue that also has to be renewed constantly, because you lose your skin from the outside. There are stem cells below the surface of the skin that regenerate it.

Other tissues, such as brain, muscle, liver, and kidney, are relatively static tissues. They don't undergo a lot of constant renewal, but they still have stem cells—and those stem cells are involved in regeneration and repair as often as needed. So if you damage your muscles through overexercising, as I do periodically, then the muscle has to be repaired; and it's the stem cells that do the job.

Of course, muscle can be damaged by more serious illnesses. Again, stem cells are the key to success in repairing that damaged tissue.

Many adult stem cells of this kind have been described only in the last few years. Neural stem cells, for example, were first described in Calgary about five or six years by a Canadian scientist.

Embryonic stem cells, on the other hand, are cells that exist only in the very, very early embryo, only four or five days old—even before the embryo becomes implanted in the uterus. At that stage, there's a sac of cells, with cells in its interior that will make the developing embryo; and the cells in the sac itself will make the membranes and the placenta.

It's the cells inside, the so-called inner cell mass, that we refer to as embryonic stem cells. They have the capability of making virtually any cell type in any tissue. They have to, because that's their job in the early, early stage of embryonic development. In the mouse, for example, we know that you can take one stem cell from that population, and recreate an entire mouse from that one stem cell. We know it's capable of making every tissue, and making a fully functional mouse.

We presume that, in humans, the early embryo stem cells are capable of doing the same thing. But of course you can't experiment, or at least it hasn't been done.

So what is new, and why do we have such a sudden interest? We've known about blood stem cells, for example, for 30 years. Two things are new, and Mike Rudnicki may re-emphasize these.

About three years ago, in 1998, two experiments triggered an avalanche of new work, new thought, new paradigms, in this field. One was that for the first time, scientists were able to grow human embryonic stem cells in culture. That had been a difficult task before. While most embryonic stem cells were easy to grow, humans had proved more difficult.

As of 1998, it became possible to grow human cells. That opened up a new spectrum of how to use human embryonic stem cells.

The other event in 1998 was the first clue that maybe some of these adult stem cells can make different tissues. In other words, a stem cell taken from the bone marrow, which is normally involved in making blood, might be able to make muscle; or a stem cell from the muscle, which is normally there to make muscle, might be able to make blood cells if you put it into the bone marrow.

There were other examples. Stem cells in the brain that normally make neurons were able to make blood; stem cells from the blood could make neurons. They don't do this terribly well, but they do it. And this is the first step in a process that we think might allow us to take stem cells from one tissue and use them to repair a different tissue. That's really important, because if you could take stem cells from an individual and repair a different tissue in the same individual, then you eliminate all the problems of immune-system rejection we normally face with any kind of tissue or cell transplant.

So these were two key discoveries, and this is what created all the stir in the last three years and resulted in the consideration of legislation in this regard in Canada, in Great Britain, in the United States, and so on.

One argument that's been made is that since adult stem cells may be capable of making these various tissues, why don't we just use adult stem cells for research and for the eventual treatments? Why do we even need to work with embryonic stem cells at all?

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The answer is that, in the end, we hope it will be case that adult stem cells will be the source of all cells we use for therapeutic purposes, and we won't have to use embryonic stem cells. But right now, we know that embryonic stem cells have a lot more potential. They're said to be “pluripotent”—they can make any kinds of tissue, and they do it with a high level of efficiency.

We know adult stem cells can make certain other tissues, but we don't know the full spectrum of what they can make. We know they're not as efficient, and they're somewhat difficult to grow. So we think there's an absolute necessity to work with embryonic stem cells and adult stem cells, and fully understand the differences between them, if we're ever going to have a hope of utilizing adult stem cells to their full potential.

Let me give you just one example. There's a group that has formed a network of centres of excellence right across Canada, called the Stem Cell Network. We've recently been funded by the federal government for $21 million over the next four years.

One of the main experiments we want to do is try to understand what the molecular events in a stem cell are. What are the molecular characteristics of an embryonic stem cell, and what are the molecular characteristics of an adult stem cell? What are the differences?

We think if we understand that, we'll be able to take adult stem cells and manipulate them—add in any molecular factors that are missing, and make it more like an embryonic stem cell. Give it more potential, if you like. But if we don't understand what the factors are in the embryonic stem cells, then we don't have a hope of making adult stem cells behave as though they came from embryos.

That's a major part of the goal of our research. Therefore, we have to work with embryonic stem cells, even though the long-term goal is to avoid their use. Obviously, we would prefer to work with adult stem cells.

That was my main point in addressing the science. The future for stem cell research is very bright if we're able to work with human stem cells. There's a huge potential here for using stem cells to repair tissue damage caused either by injury, as in spinal cord injury, or by disease, as in muscular dystrophy. You'll hear more about that.

The effort will be huge: it's going to take five to ten years to get to some of these therapies. But I think the path is clear now, and I think the outcome is a given: we'll have treatments for many of these degenerative diseases. The only thing we don't know is how long it's going to take, and how much experimentation we have to do to get there.

I'd like to end with a couple of specific comments on the legislation itself. I've already said that it is good, and I do support this legislation and all its principles. If I'm interpreting it correctly, it will allow researchers to carry out a lot of the necessary research with stem cells in order to make stem cell therapy a reality.

I also support the need to impose restrictions on the research, to provide clear limits and guidelines on what can and what can't be done—for scientists as well as for the public.

I do have some concerns about segregating the activities into the categories of “prohibited” and “controlled”, as the bill does. If I'm reading it correctly, it leaves no option of moving something from the prohibited category to the controlled, or regulated, category—if research defines new options for the future, or if public attitudes change on the basis of that research.

I'm a little bit worried that if we have to move something from the prohibited to the controlled category in the future by rewriting the legislation, that is a long process. As one of my colleagues said a few minutes ago, the time is measured in generations rather than in weeks or months.

Tim Caulfield and Bartha Knoppers, both lawyers and both people who have thought deeply about genetics and stem cells, and the use of gene therapy and cell therapy, wrote an op-ed piece in the Globe and Mail about two months ago. I think I've provided you with a copy of that.

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The title was “Don't Make Science a Crime”, and their point was precisely that: if we can regulate something, you can prohibit it for now, but let the regulatory body deal with changes as the research progresses. I would echo that theme.

The case in point is, no person shall knowingly create an in vitro embryo solely for the purpose of research. At the present time, I think this is a valid, useful, and wise prohibition. I just think that it may not always be that way, and in 10 years—or even in five years—we might want to re-evaluate it. So a solution is to provide a mechanism for re-evaluating all the prohibited activities, and perhaps assign the regulatory body the task of doing that.

Finally, as I was going through the legislation, I picked out a few examples where, from a scientific point of view, definitions were either incorrect or problematic. I don't think it's my job this morning to go through and point them all out, but I do recommend that you have a group of knowledgeable scientists go over the legislative package with a fine-toothed comb. I'm even willing to suggest that maybe the CIHR working group, which proposed the original stem cell legislation, could be part of that process.

If I could just give you one example, subclause 9(2) talks about not mixing together DNA or genetic material from two different organisms, such as humans and mice. I know the intent of that is to say that you don't want to create some kind of a hybrid organism, and I fully agree with that. But in the laboratory, we mix those together all the time. We make things called “somatic cell hybrids”, single cells that are part-mouse, part-human. We do that to map genes—we've been doing it for 30 years—and no harm has ever come from it.

So somebody needs to go through and flag things like that, and say the intent is correct here, but the way it's worded could block us from doing some things we've been doing for 30 years. Let's not do that. I'm just suggesting a mechanism for that.

Thank you.

The Chair: Thank you, Dr. Worton.

Dr. Rudnicki.

Dr. Michael Rudnicki (Canada Research Chair in Molecular Genetics, Senior Scientist and Director, Molecular Medicine Program, Ottawa Health Research Institute): Thank you very much.

I'd like to begin by thanking the committee for the opportunity to speak to you today. I started working with mouse embryonic carcinoma cells—the original embryonic stem cells—about 20 years ago, as a fourth-year undergraduate student. I distinctly remember the thrill of looking down the microscope and seeing networks of neurons and masses of beating heart tissue directly derived from these stem cells. In late-night conversations, we excitedly speculated that such cells could one day, in the very distant future, be used to treat human diseases. That day is almost upon us.

Two decades later, my laboratory is currently working on understanding the molecular mechanisms that specify the identity of adult stem cells, and regulate the fate of differentiation. We recently identified a control gene called Pax-7, which is required for these stem cells to decide what they're going to be when they grow up. This discovery raises the possibility of using combined gene therapy and cell-based therapy to direct stem cells down particular pathways, for the treatment of diseases such as muscular dystrophy.

Today, I'm first going to talk briefly about embryonic stem cells and adult stem cells—I won't repeat what Dr. Worton said, so I'll paraphrase my comments there. Second, I'll speak to specific concerns I have regarding certain aspects of the proposed regulation. These points mostly deal with the consequences that'll happen with stem cell research.

Stem cells are broadly defined as having the ability to, first, make more of themselves, which is self-renewal; and second, the ability to give rise to differentiated cell types. As embryonic development proceeds from a single cell, the fertilized egg, to a multicellular embryo and then on to a fetus, stem cells were believed to become progressively more specialized and more restricted in their ability to make different cell types. However, we now understand that both embryonic and adult stem cells have the capacity to differentiate into many different cell types.

How will ES cells and adult cells be used therapeutically? ES cells can be grown and differentiated in tissue culture to produce very, very large numbers of cells for transplant or tissue engineering. In fact, there are probably over 20 biotech companies in the United States working on this problem today.

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Adult stem cells, by contrast, cannot be easily grown in tissue culture, but they can be introduced in small numbers into the blood system, where they can home in on areas of damage, participate in tissue regeneration, and give rise to, as you've heard, many different cell types. We've been doing this in the clinic for at least a couple of decades. A bone marrow transplant is exactly that—a transplant of adult stem cells to reconstitute the bone marrow system.

However, many problems remain, and our understanding of what makes these cells tick is very superficial, at best. We cannot predict which cell is better for therapeutic use. It is absolutely necessary, as you heard, to study both embryonic and adult stem cells to understand both their similarities and their differences.

The proposed legislation is timely and prudent, and brings a necessary level of oversight and regulation. As a scientist, I welcome the coming legislation because it will allow us to get on with the work. Moreover, the existence of a regulatory structure is important for science because it protects the front line worker from the perception of abuse, as well as prevents actual abuse. The legislation is clearly a high priority for Canadian scientists. Nevertheless, I do have several concerns.

The long delay in the implementation of the legislation has resulted in a regulatory vacuum that has negatively impinged on stem cell research. For example, no human ES lines have been derived in Canada, and very few Canadian researchers, if any, are working with human ES cells. Many other countries around the world have research centres that have derived multiple human ES cell lines. Canada has fallen well behind the pack. Therefore, time is of the essence.

Overall, I agree with the intent of the legislation to bring regulatory oversight to new reproductive technologies. I'm not so sure that bringing certain activities into the Criminal Code is wise. For example, the creation of life by nuclear cloning is to be criminalized. However, the legislation also criminalizes the use of nuclear cloning in research. This issue is not so cut and dried.

The National Academy of Sciences in the U.S.A. recently released a report, authored by a committee headed by John Hopkins biologist Bert Vogelstein, that endorses therapeutic cloning. This would be for the purpose of producing tissue that is genetically matched to patients. Indeed, a strong scientific argument can be mounted that it may be important to nuclearly clone cells, for example, from a patient with a lethal genetic disease, to generate ES cells with that particular genetic deficit for study in the lab.

Our repulsion at the thought of creating life using nuclear cloning has resulted in a blunt approach that fails to effectively discriminate the nuances that exist between reproductive technology and research in the laboratory. I suggest we can use other tools such as moratoriums, rather than outright criminalization, that will allow a less rigid regulatory environment.

Do we need a new regulatory body based in Health Canada to oversee assisted reproduction and related research? I'm not so sure we need to recreate the wheel, as the basis for this instrument already exists. All research in humans is currently governed by hospital-based research ethics boards. A national self-governing body could be created to certify the local boards, conduct site visits, review changes in technologies and in the ethical landscape, and most importantly, after dialogue with the local boards and scientists, issue specific guidelines.

A model for such a body already exists, and it's called the Canadian Council for Animal Care. Its job is to oversee the animal research boards at university and hospital-based centres. I would argue that this mechanism would be a more efficient, responsive, economical, and less bureaucratic approach than to give Health Canada this mandate.

In conclusion, the benefits of stem cell research for health care are predicted to be enormous, especially for the treatment of diseases for which there are currently no effective therapies. It is therefore very important that Canada's regulatory environment facilitates basic and translational research.

Do we want to create a rigid code of conduct for stem cell research when the issues form a grey gradient rather than present themselves as black and white choices? Do we require a large bureaucracy to oversee research activities when local research ethics boards can do the job? Clearly, the existing regulatory mechanisms are already effective, as no human ES cells have been derived in Canada.

I urge the committee to carefully consider the consequences for scientific research, if the proposed legislation is implemented in its current form.

Thank you for the opportunity to present my views.

The Chair: Thank you, Dr. Rudnicki.

We'll move now to the Muscular Dystrophy Association and ask Mr. Yves Savoie, the national executive director, to begin.

Mr. Claredon Robicheau (President, Southwest Nova Scotia Chapter, and Member, National Board of Directors, Muscular Dystrophy Association of Canada): Thank you very much.

The Chair: Mr. Robicheau. Fine.

Mr. Claredon Robicheau: We're going to be partners.

Thank you, ladies and gentlemen, Madam Chair, members of the Standing Committee on Health, for considering the position of the Muscular Dystrophy Association of Canada and the views of people with neuromuscular disorders.

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[Translation]

My name is Claredon Robicheau. I am a member of the Muscular Dystrophy Association of Canada's Board of Directors, President of the MDAC southeast Nova Scotia Chapter and President of the Board of Directors' Advocacy Working Group. I am also a person affected with limb-girdle muscular dystrophy. With me is Yves Savoie, the Association's National Executive Director.

[English]

We are here to present the view that the proposed legislation must include a framework for regulating the use of stem cells for treatment in therapies, not only for research purposes. We are hopeful that stem cell research will yield promising results in the coming years. This legislation must also contemplate the impact of successful results, and must provide direction to the scientific community about how to ensure that people living with disabilities and disease can get access to such treatments that may improve quality of life, extend lives, and find cures.

The medical, legal, and ethical challenges presented by research involving human reproductive materials are divisive, and freighted with implications at all levels of human endeavour. They demand reflection and debate. These debates must take place throughout society—in the chambers of parliaments, at community and organizational meetings, and at family kitchen tables.

[Translation]

My family is from Meteghan, Nova Scotia. Three of my siblings are also affected with limb-girdle muscular dystrophy. Believe me when I tell you that we've had several, sometimes passionate, debates on these questions, much like those we've had within our organization, MDAC. Today I will present you the viewpoint of the Association, which I share. This position is the result of extensive consultations with our members, volunteers and governing structures. However, we recognize that not all MDAC members share this position. Therefore we encourage these members to contact their members of Parliament and present their viewpoints directly to them.

Fundamentally, MDAC's position reflects its twofold mission: research and client services. Research not in and of itself but research that translates into improving the quality of life of affected people. The principle of supporting research in the service of individuals guides not only our daily work but also informs our recommendations.

We believe that in the very near future, stem cell research will deliver concrete results for those affected with many disorders.

[English]

With such a framework of hope, we cannot stop at examining legislative considerations of utilizing human stem cells for research alone. Once there are scientifically proven means to utilize embryonic stem cells in treatments and possible cures, what then? Scientists assert that the demand for embryonic stem cells will exceed the supply of in vitro embryos not needed in fertility clinics. We need to explore all potential sources of stem cells, including adult tissues.

When this legislation is introduced, it must include regulations that permit the production of human embryos through gifts of donors or through production of human embryos from other DNA material, if research efforts confirm their lifesaving and disease-curing properties. This activity would occur only within a strict regulatory framework, only with embryos in the first 14 days, only if there is insufficient supply from other sources, and only in the service of human treatment.

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The standing committee must act now to consider this scenario so as to avoid long delays for lifesaving therapies once research yields clinically proven treatments that depend on human reproductive materials. We recognize that it can take years to turn research into a usable medical therapy, and we know it also takes years to create new laws. The realities of parliamentary process and shifting priorities mean that Canadians living with neuromuscular disorders and other progressive and degenerative diseases would have to wait too long.

That fundamental connection between health research and improved quality of life for Canadians is one that you, as parliamentarians, strengthened with the creation of the Canadian Institutes of Health Research. Your work in making the federal government's contribution to health research more connected to improving the health of Canadians is, in fact, a parallel to what we have to say today.

Muscular dystrophy is the name of a group of muscle disorders characterized by progressive weakness and wasting of the voluntary muscles that control body movement. As muscle tissue weakens and wastes away, it is replaced by fatty and connective tissue.

Specific neuromuscular disorders vary in many ways—the muscles that are chiefly involved, the severity of the symptoms, the age at which the symptoms appear, how fast the symptoms progress, and what pattern of inheritance the disorder follows. Many neuromuscular disorders are genetic, and many of the genes that cause these disorders have been identified by Canadian scientists during the last 15 years.

[Translation]

I am personally affected with limb-girdle muscular dystrophy. Essentially this disorder affects the voluntary muscles around my shoulder and hip areas. I have had to use a wheelchair for the past 11 years and the progress of the disease forced me to leave my position with the Toronto Dominion Bank some 9 years ago. I am very much aware that I will have to face many such transitions in the coming years.

[English]

While Canadians with neuromuscular disorders are all affected differently, for all of us time is at issue. The impact of these progressive neuromuscular disorders cannot be understated. Adults and children living with these disorders have chronic and severe disabilities that affect all aspects of their lives, and in some cases reduce their life expectancy. They are also active and fully contributing members of our communities. People living with neuromuscular disorders have a right to enjoy a good quality of life as independent, mobile, and productive Canadians.

[Translation]

The Chair: Thank you, Mr. Robicheau.

Mr. Savoie.

Mr. Yves Savoie (Executive Director, Muscular Dystrophy Association of Canada): Thank you, Madam Chair.

We have already seen how advances in areas such as genetics, steroid treatments and respiratory care have extended the life expectancy of many MDAC clients. Clients who were not expected to live past their teenage years are contemplating college and university, and are entering the workforce. Long-term commitments, independent living and even retirement are now real possibilities.

However, as people with neuromuscular disorders make the shift from youth to adulthood and enter the arenas of higher education and the workforce, they often are not permitted to reach their full potential and face barriers to employment, higher unemployment rates, lower wages and, as a result, poverty. They must also live every day with disorders that worsen progressively.

The time is at hand to devise a more future-minded and permissive legislation that incorporates guidelines for the utilization of human stem cells in the production of effective therapies and treatments. We cannot wait until some undefined “later” to address this issue. If research efforts produce successful therapies using embryonic stem cells, success that is demonstrated in human clinical trials as per recognized scientific approaches, then the legislation must already be in place to guide and monitor scientists.

Moreover, this legislation must be permissive and allow for the production of human stem cells through various means so as to avoid long delays in the translation of these life-saving benefits for Canadians.

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If we imagine that stem cells can deliver effective treatments, then we must address the thorny issue of supply. Where will we find the necessary quantity of stem cells to meet the demand placed upon them by Canadians living with disease and disability of numerous types?

The present state of knowledge suggests that the embryonic stem cells have properties that make them particularly promising—promise not yet demonstrated by stem cells from adult tissues or any other source.

Using only stem cells harvested through leftover embryos produced for human reproduction will not be sufficient for the application of new knowledge to effective therapies. Of particular concern is a potential abuse of in-vitro fertilization as a back- door way of dealing with a growing need for stem cells. This would injure the sound principles upon which are based the proposal for assisted human reproduction.

Moreover, there is a strong scientific case for a more generous and diverse supply of stem cells; some of these arguments were made earlier by Dr. Worton. Stem cells reveal natural biological variations; studies in mice have demonstrated that the ability of the mouse to accept stem cells varies given this natural biological variation. There is the possibility that some embryonic stem cells would create immunogenic reactions in adults. A sufficient quantity and a wide range of types of stem cells would need to be available to overcome this problem of variability. In time, we may also discover that certain stem cells, given natural biological variations, would work better in repairing certain tissue. There is also the fact that while stem cells are theoretically immortal, some stem cells die.

Finally, foresight suggests that providing the necessary volume of stem cells required for treatment across large populations will prove difficult.

What will serve as supply sources of embryonic stem cells when treatment for large populations become available? Two options are currently foreseeable. First, people could donate their eggs and sperm, giving their full consent that they would be used exclusively for the purpose of human treatment and with the knowledge that the embryonic stem cells would be harvested in the first 14 days.

The second option would be to clone embryos from other DNA material. This is more contentious but it has one clear advantage: the embryos created could be created autologously (from one's own DNA) or from a close relative's DNA, and the resulting embryonic stem cells made available for treatment might reduce the risk of immunogenic reaction.

We must underscore our firm belief that science should proceed with caution and with respect. We also affirm that we prefer a vigorous pursuit of every alternative source of stem cell. However, we wish to keep the door open to all choices, even if the only remaining alternative is the most difficult. And we must provide regulations that foresee successful results and contemplate the issues success will present so that science does not proceed in a legal and ethical vacuum.

[English]

MDAC is committed to a strong regulatory framework to oversee all assisted human reproduction technologies. We encourage the participation of scientists, professionals, and experts on the regulatory body, as well as the participation of Canadians living with a chronic and severe disability. Theirs is an essential contribution to the discussion: the perspective of those who can benefit directly from these advances.

This committee must now act to include regulations guiding the use and supply of stem cells in a best-case scenario, where successful treatment modalities have been found. That success story is waiting to happen. Let's ensure that the millions of Canadians living with a number of diseases and disabilities don't have to wait years to benefit.

The Muscular Dystrophy Association of Canada thanks you for your invitation and your consideration of our viewpoint on this landmark legislation. We welcome questions related to your presentation.

The Chair: Thank you, Mr. Savoie.

I'll now ask Dr. Thérèse Leroux, director of ethics at the Canadian Institutes of Health Research, to make her presentation.

• 1155

[Translation]

Ms. Thérèse Leroux (Director of Ethics, Canadian Institutes of Health Research): Madam Chair, distinguished members of the Standing Committee on Health, ladies and gentlemen,

[English]

thank you for inviting me to appear before the Standing Committee on Health to present CIHR's position on the issue of embryonic stem cell research as part of this committee's examination of the draft legislation on the assisted human reproduction.

[Translation]

As you have already heard this morning in previous presentations,

[English]

stem cells have the potential to treat many of the diseases that today cause tremendous pain and suffering to individuals and their families and that cause ongoing costs to our health care system and our economy.

[Translation]

These diseases include Parkinson's disease, Alzheimer's, diabetes,

[English]

multiple sclerosis, heart disease, and spinal cord injury. Although stem cells from adult tissue are a potential source of cells for cell-based therapy for degenerative disease, a very promising source in terms of versatility and growth potential is embryonic and fetal tissue, the so-called embryonic stem cells. It is in this area that there are also serious ethical and legal concerns that we cannot ignore.

Canada today has no guidelines specifically governing the use of human embryonic stem cells in research. This lack of a public policy leaves researchers, research ethics boards, and funding agencies without the guidance they need and Canadians expect.

The federal government's draft legislation on assisted human reproduction is a welcome initiative that will provide a legislative framework around the practice of assisted human reproduction and the use of the human embryo in research.

CIHR, working with Health Canada, has redeveloped the thinking around our guidelines for embryonic stem cell research and a subsequent funding policy. It is fortunate that we are able to have this dialogue with Canadians at this stage of the development of both the legislative framework for assisted human reproduction and the CIHR guidelines for stem cell research findings.

Canada is not the only country concerned with developing guidelines for stem cell research. Both the United Kingdom and the United States have recently developed policies on stem cell research using cells derived from embryos and fetuses. These two countries have taken different approaches to stem cell research using embryonic and fetal tissue. But they each have the advantage of a clear directive for researchers.

Canadian scientists have made historic contributions to stem cell research, starting with

[Translation]

Dr. Leblond in Montreal in the 1950s.

[English]

Today Canadian researchers are among the world leaders in this area of research. Our country needs guidelines to ensure that this important research can continue, but only within an ethical framework that satisfactorily addresses the legitimate concerns around the source of stem cell used for research—issues of involved, informed choice; consent; privacy and confidentiality; and commercialization and profit motives.

That is why CIHR established a working group on stem cell research. We brought together an outstanding group of experts in health research, ethics, health policy, and law to assist us in setting national policies in this area. Their work may also contribute to the development of a coordinated national policy in this area.

I would like to invite Canadian voluntary health groups and other organizations to become involved in this important discussion.

[Translation]

The working group invited feedback from all interested parties over a three-month period ending June 29, 2001. Of the 110 responses received, 25 were from special interest groups, professional groups, health charities or government agencies. There were also 65 responses from individuals, a minority of whom indicated personal or professional interest in stem cell/embryo research, for example, clergy, physicians, philosophers, and potential clients of these technological developments.

• 1200

The consultation process was very useful in identifying many areas of concern, all of which are being considered by the working group during its current deliberations and drafting of a final report to the Canadian Institutes of Health Research.

The most contentious ethical issue arising from stem cell research appears, not surprisingly, to be the derivation of embryonic or germ cell-derived stem cells. This opinion is divided. Some believe that the human embryo is a being with full moral status from the moment of conception and has an inalienable right to life. Others consider that an early human embryo is just a collection of cells; its moral status equivalent to that of any other cells in the body. The working group's position is the graduated approach expressed in the Tri-Council Policy Statement. The human embryo has a specific moral status as a potential person. In this view, the human embryo has neither the full moral status of a person nor an absolute right to life.

In addition to ethical questions about the source of the research material, there are important ethical questions about a range of other issues such as free and informed choice. Who should provide consent for the research use of this material? Should directed donation be permitted, and if so, under what circumstances?

There are also concerns about the potential commodification of women and human life. Should there be payment for the research material? As well, there are issues of privacy and confidentiality. To further elaborate on the range of questions, can we draw distinctions between treatment and enhancing research objectives? What guidelines should there be regarding commercialization and patenting? Who should benefit financially from the research?

Some of these issues are addressed in a very general way in the Tri-Council Policy Statement. These guidelines, however, do not provide the specific guidance that is needed for research involving human pluripotent stem cells. We are recommending that the Tri- Council Policy Statement be revised to effectively address these ethical questions.

[English]

At this stage of our deliberations we have attempted to clarify the research that is currently permissible under the tri-council policy statement. We have not as yet provided guidelines on the range of ethical issues identified. We believe that researchers, ethicists and the Canadian public need to express their views on how we deal with these issues and help develop answers to some of the difficult ethical questions in this new research area.

[Translation]

Before I close my presentation, I would like to invite you to check our Web site in order to access our discussion paper on proposed guidelines for funding of human embryonic stem cell research in Canada.

[English]

You will be able to read our recommendations. Among them is one related to the creation of a national oversight body to provide ethical review of all such research, whether publicly or privately funded, to complement the work of the institutional research ethics boards.

[Translation]

Thank very much for your attention.

• 1205

[English]

The Chair: Thank you, Dr. Leroux.

Now, ladies and gentlemen, we'll proceed to the questions.

Ms. Ablonczy.

Mrs. Diane Ablonczy (Calgary—Nose Hill, Canadian Alliance): Thank you, Madam Chairman.

Thank you for your presentations, from individuals who represent those with medical conditions that we very much hope can be addressed by some of this new research. I have a very dear friend with Parkinson's, and I know most of us have friends, acquaintances, or families with some of the medical conditions you all are working with every day.

I guess the real issue for people, to get to the bottom line, is the right balance between freedom for researchers to develop treatments and therapies that will address the conditions you know about, and concern about the need to respect and protect the elements of human life to the greatest degree possible. That really is what we in this committee have to weigh to come out with the right balance.

I thought it might be helpful if you all made known to us your perspective on how that balance could best be achieved, because I know you've struggled with it as much as, or more than, we have.

Ms. Mary Jardine: I would be happy to begin.

This is obviously the issue that is going to be a stalling point in many organizations. Parkinson Society Canada has taken the approach that we fully agree with the principled approach taken by CIHR and Health Canada in this initiative. We understand and appreciate the ethical dilemmas all the way along.

Your question regarding the balance between the freedom of researchers and the whole issue of the element of human life is a very touchy one. In fact I'm sure there are many people within our community, the Parkinson community, who might oppose this legislation, although we do have a national consensus to support it.

It is a very difficult question. We did not want to get involved really in the ethical issue. People need to make that choice and that decision on their own. But as an organization we certainly have taken the view that we support the research process and the progress in human embryo and stem cell research.

I don't know, David, if you would have anything to add.

The Chair: I'm going to have to caution you. If everyone's going to comment, I'm going to ask you to please do it in about 45 seconds each.

Ms. Mary Jardine: Okay, my time's up.

The Chair: Does everybody understand the question, or would you like it repeated?

Diane, just say again what it is you want them to comment on.

Mrs. Diane Ablonczy: Your perspective on the proper balance between the need for freedom in research with all its potential benefits, and the need to protect the value and inherent dignity of human life and the elements of human life.

Mr. Claredon Robicheau: May I speak on a personal matter? When this issue was talked about at our general meeting of the Muscular Dystrophy Association of Canada in Victoria, I had to go home and personally think about ethical and moral issues—being a Catholic—and my own family, my own community. The decisions made here soon and in the following months contain very big ethical issues that the community at large, from Newfoundland to B.C., will be asking you about, and asking me about.

I've directly looked at the MDAC proactive approach in treatments and cures, not just research for research's sake, and I have spoken to my family—my father is 75 years old, and my mother 65—to make sure they understood the ethical things I was coming here to Ottawa to talk about.

They understood very well that we're talking about embryos that are 14 days old, not 11 weeks old, as for legalized abortion in Canada now. So they're very comfortable with that.

• 1210

I even went to the point of asking my baby brother about donating sperm, DNA, any type of material to advance the research stage, if need be, next year, in five years. I wanted to make sure he understood that we're opening a door, and not closing it to all these moral issues about donating DNA. This was for treatment and treatment only, not to create a new baby brother.

There's a big difference from a scientist in Europe who says, I'm going to clone somebody someday. That's not what this is about. This is about treatment and cures, and we have this 14-day limit. I think that's fundamentally why my family and a lot of clients I've e-mailed about this legislation across Canada came back with no problems, because we're talking about 14-day embryos, not further than that.

The Chair: Does anybody else want to comment on the question?

Dr. Thérèse Leroux: Yes, I would like to.

If you look at our tri-council policy statement, you will realize that one of our paramount principles is human dignity. If you look at chapter 9, you will realize that we are against it. It's not ethically acceptable to create an embryo only for research. But we also realize that the use of embryos in this type of research might be very beneficial for the community, for people who are suffering from those diseases, so we are willing to use embryos that are not in a family plan of those who gave this material.

Then we said we need very strong guidelines about consent, and that's why in my presentation I didn't focus only on the moral status of the embryo, but also on consent, privacy, and all those issues related to this type of research. I think it's very important to make this link with human dignity, but there is also the use of this material that may save lives. So we need an ethical framework. That's maybe the way to balance those things.

The Chair: Thank you, Ms. Ablonczy.

Mrs. Diane Ablonczy: Thank you. I think those comments are very helpful, Madam Chair.

The Chair: Mr. Dromisky.

Mr. Stan Dromisky (Thunder Bay—Atikokan, Lib.): Thank you very much.

This past summer President Bush made a statement regarding stem cell research, and in his presentation he talked about stem cell lines. He presented a number that was very high. In the next few days scientists made comments in Canada and the United States, as well as in Europe, about the number. They questioned it. Many scientists who have been involved in this area of work for quite some time were surprised that the number was so great.

Can you, first, tell us what is a stem cell line, and give us further information regarding the potential for development of new lines? What is the potential for the future? Is there a limit on the number of lines that can be developed? Will this legislation that has been proposed in any way impede or prevent the development of further new lines or additional lines to the inventory that scientists in Canada already possess, and so forth? I'm seeking just a general reaction to all this.

The Chair: Dr. Worton.

Dr. Ronald Worton: Let me start, but I think Dr. Rudnicki may also want to comment.

A stem cell line is a pretty simple concept. If you remove this inner cell mass from the embryo, the 100 cells or so, grow them in cell culture, and those cells begin to divide, so that as each of the 100 cells divides, they make 200 cells and then 400, basically that's a line. You can clone cells, and it doesn't have the same connotation, of course, as cloning people, but the essence is the same. That is, you can pick one cell and let it divide and make two and then four and then eight, and then you have a clone line, because all the cells are derived from one cell, so they should all be pretty much identical to one another. So those are cell lines.

• 1215

One of the important things to understand is that when we work with biological systems and things like cells, there's a huge amount of variation. So even though one stem cell is pretty much similar to another stem cell, the way it grows, the capacity it has for differentiation, may very well depend on exactly where it comes from, what time it was taken, how it was cultured, what kind of medium it was put into to culture it, how frequently the cells were passaged from one dish to another to expand the numbers, and so on. Some cell lines are clearly better than others. Some of them will differentiate better than others. Some of them will divide and replicate better than others.

One of the reasons we need to work with more than one cell line is this biological variation. There's a general feeling right now that maybe the methods for developing those cell lines, for taking them from the embryo, for the kind of medium you put them in to grow them, will improve over time, and therefore the cell lines will improve. So we don't want to really be constricted by having to work with a finite number of lines.

I can't really address the issue of how many lines there are, because I don't know what sources of information President Bush had when he declared there were 60 cell lines. Clearly some of those are within companies; they've been created by companies in the United States, and they are available if you wish to purchase them from those companies. I think we need to be making cell lines of that kind in Canada freely available for researchers.

To answer your last question, about whether the legislation will allow us to do that, I think it will. I think it will allow us to create new cell lines from existing embryos, embryos that are sitting in a freezer, embryos that were taken for other purposes, usually to create life, but the couple who created those embryos have now completed their families and they're not planning to have any more children. There are only three things that can happen to those embryos: they can be discarded; they can be retained in the freezer forever; or they can be used for research purposes, because pretty clearly they're not going to be used to create more human life.

The Chair: Mr. Rudnicki, would you like to add anything?

Dr. Michael Rudnicki: I believe there will be an ongoing need for additional cell lines. ES cells have a limited lifespan in culture. They are technically immortal, but what happens is that they accumulate mutations, and there is genetic drift in that population as you passage it and they go off. Fresh ES cells behave very differently from old stocks, so the naive notion that 60 is sufficient forever is simply untrue.

That being said, we will also need a diversity of ES cells, because with ES cells, because of those changes that occur, one particular line might be better at making pancreatic beta cells, while another line might be better at making heart tissue. That's one thing. Also, one could imagine a need for having a bank of ES cells that are immunologically matched to donors. So there will really be a need for creating these on an ongoing basis.

Whether or not the leftover embryos will provide sufficient numbers is debatable, as we heard. That's really a big question.

Mr. Stan Dromisky: Thank you very much.

The Chair: Thank you, Mr. Dromisky.

Mr. Ménard.

[Translation]

Mr. Réal Ménard (Hochelaga—Maisonneuve, BQ): Thank you, Madam Chair.

I really appreciated the interaction among the various presentations. I believe that it helps us really understand the importance of stem cells.

I want to come back to the recommendations made by Mr. Savoie to make sure that I understand them properly.

In your first recommendation, you say that one of the first possibilities would be for people to donate eggs and sperm with informed consent. That is already possible in fertility clinics. How would your proposal be different? Stem cells cannot be produced from eggs, only from embryos.

Mr. Yves Savoie: Right now, egg and sperm donations can be done in the case of fertility treatments, in order to create pregnancies. Donations are permitted, and they would be under the draft legislation in that context, for fertility treatments. Surplus embryos created for that purpose would be available for research activities, as long as informed consent was given.

Our proposal deals only with the phase where research could provide proven therapies. At that point, surplus embryos created for fertility treatment purposes will not supply enough stem cells for therapeutic applications.

• 1220

So we are proposing that the bill allow for donations of eggs and sperm strictly for the purpose of treating diseases such as cancer, Parkinson's disease and muscular dystrophy. Of course, informed consent will always be required, but we believe that exactly the same mechanism could be used for this new purpose as is already used for fertility treatments...

Mr. Réal Ménard: But it is the embryo that would be used.

Mr. Yves Savoie: That is right. Within the first 14 days.

Mr. Réal Ménard: All right. Concretely, you say that you are worried about a lack of supply. You have shown us the very promising potential of stem cells. Would you like us to include in the bill a prohibition for a certain period? For example, would you like us as legislators to say that embryos cannot be used for research purposes for the next five years? Basically, that would come down to a moratorium rather than a permanent prohibition. Is that the kind of legislative change you would like to see?

If Dr. Worton would like to speak to this as well, I would be pleased to hear what he has to say.

Mr. Yves Savoie: The message that came out of a number of the presentations was that greater flexibility is needed, even though we recognize the value of a strong monitoring and regulatory framework. In fact, that is the solution that the British Parliament opted for by creating a more permissive framework but establishing as well a monitoring system and mechanisms to make it possible to adapt to changes brought about by new discoveries.

Mr. Réal Ménard: Concretely, would you prefer to see a moratorium rather than a prohibition?

Mr. Yves Savoie: Absolutely. Right now, any use of stem cells for treatment purposes is prohibited. What will that mean if treatments are discovered in five or seven years? We will be a long way behind, since it will take a great deal of time before a future Parliament reviews the legislation and opens the door so that the new technologies can be used for therapeutic or treatment purposes.

Mr. Réal Ménard: Concretely, as legislators, we have to take one side or the other. Either we prohibit it... There are 11 prohibitions in the draft legislation, and you are saying that one of them might compromise the future of research activities. Earlier, Mr. Rudnicki or Dr. Worton said that it might be better to have a moratorium. A moratorium can be voluntary. Diane Marleau imposed a moratorium on nine prohibitions. How can this be done from a legislative point of view? That is what we need to think about.

Mr. Yves Savoie: That authority could be left to the council that is provided for in the draft legislation and that would be responsible for regulation and monitoring. That could be delegated to the council under the act, or the act could stipulate a moratorium for a certain period of time. Either solution would seem to me to be satisfactory.

Mr. Réal Ménard: Do I have the time to ask one last, short question, unless you wanted to say something on that?

[English]

Dr. Ronald Worton: If I understand the question correctly, it relates to how to deal later with items that are currently banned or legislated against. I guess what I was suggesting is either make all of these banned activities regulated and have a moratorium on them, but allow a periodic review so they can be allowed in the course of time, if both the research and public attitudes change; or even at this time, look at the list of 11 that are there now and ask whether there are a few—one, two, or three, whatever—that you might consider would be allowed sometime in the future if research and public attitudes change.

[Translation]

Mr. Réal Ménard: You know, the draft legislation already provides for a review after five years. The second last section provides for a review five years after the enactment of the act. That is already there. But the idea that there could be a moratorium is one that I find interesting. We will have to check with the officials to see whether that can be drafted. We have to respond to ethical concerns without compromising the future of research.

Here is my last question. Michael, you said Canada was lagging behind and that certain activities were not being undertaken in Canada. What did you have in mind when you said that?

[English]

Dr. Michael Rudnicki: What I meant is that there have been no human ES cell lines derived in Canada.

The Chair: Pardon me; could you say that phrase again?

Dr. Michael Rudnicki: Embryonic stem cells. No human ES cells have been derived in Canada, to my knowledge.

The Chair: Thank you.

Dr. Michael Rudnicki: Sweden, China, India, and so on all have centres that have derived human ES cells.

• 1225

The current climate has created a frigid atmosphere, and because of the CIHR moratorium on these activities and the lack of approval via the mechanisms that exist in the human ethics board, this work has not occurred. So we are three years, almost four, behind the rest of the world in this area. And there's really no reason for it.

I think, if I may just comment on something I think is related, that we are applying a different, more stringent moral yardstick to the derivation of ES cells than we are to what's currently going on in human IVF clinics. I am concerned that our cautiousness has led us to use a heavy, blunt instrument to regulate something, perhaps overly so. Artificial insemination and fertilization have been in practice in IVF clinics for 20 years. When IVF first appeared 20 years ago, Britain considered outlawing it. Now it's standard practice. People donate sperm and eggs, and they create life for transplantation into the uterus. This is a normal feature of these fertility clinics.

[Translation]

Mr. Réal Ménard: If I go to a...

[English]

The Chair: Mr. Ménard, we're now at almost eight minutes.

Mr. Réal Ménard: The last one, Madam Chair.

The Chair: No. You've had three minutes more than everybody else.

I'm going to go to Madam Scherrer.

Mr. Réal Ménard: Life is very difficult.

[Translation]

Ms. Hélène Scherrer (Louis-Hébert, Lib.): Don't despair, Mr. Ménard, my question is along the same lines as yours, so we may just get an answer.

Thank you, Madam Chair.

Mr. Worton,

[English]

I have to tell you that your presentation was very clear

[Translation]

and you have restored my image of scientists, who often do presentations for us that we do not always understand or that are very complicated. Yours was clear and to the point. I found it very instructive.

I would like to pick up on what was discussed earlier. I heard Michael Rudnicki say that if this draft legislation went forward, that would allow activities to be undertaken or continue. I was kind of under the impression that currently it was "anything goes" and that this draft legislation would in fact limit some of your existing activities.

I would like it explained to me what are the current limits, apart from those we have already discussed, that prevent you from going ahead with your activities. Are there any limits currently? Is there any legislation that limits or regulates activities you might undertake but cannot?

[English]

Dr. Ronald Worton: If I can interpret what Dr. Rudnicki was saying—

[Translation]

Ms. Hélène Scherrer: Certainly.

[English]

Dr. Michael Rudnicki: Then I'll correct him.

Dr. Ronald Worton: —then he'll correct me, as he usually does.

There hasn't been any legislation or any guidelines that have prevented us from deriving ES cell lines in Canada. In the absence of policy, in the absence of legislation, and in the absence of any guidelines, there's a reluctance to go ahead for fear of being branded as a renegade or as someone doing things he shouldn't be doing. My own laboratory is quite willing to work with human embryonic stem cells, but I think that in the absence of policy or guidelines we would hesitate to do that.

Now that we have these tabled guidelines from CIHR, I think we could make the argument that those guidelines are likely to become firm guidelines and that the legislation that's tabled is likely to pass in some form similar to what is before us. Now we'll be willing to begin to work with human embryonic stem cells, given the reassurance that we're not acting outside what might be considered normal ethical limits within the country.

Dr. Michael Rudnicki: I think also it's important to note that it's not simply the choice of an individual investigator whether to work and derive ES cells or not. In order to do any work with humans or with human material, you have to have the approval of a local research ethics board. In conversation with these boards, we know that the approval would not be there without some kind of framework to work within. More recently we've had the CIHR moratorium on these activities.

[Translation]

Ms. Hélène Scherrer: So there is an ethical problem, but there is also a funding problem, right?

You are a recognized research institute. Is this going on elsewhere in institutes with perhaps more dubious research methods? You may be more closely watched because your institute is recognized, with scientists associated with a university? For example, is this kind of research being done elsewhere in Canada, but in greater obscurity? Is that the real reason why regulation is necessary?

• 1230

[English]

Dr. Michael Rudnicki: I'm not too sure I follow the question.

Dr. Ronald Worton: I'm not either, but Michael was absolutely right. For us to work on ES cell lines, as soon as it is human material, we have to have the approval of a local research ethics board. Local research ethics boards, our own included at our hospital, are reluctant to approve things where they don't have some national guideline to work from. Otherwise, they are going out on a limb, so these guidelines are proving helpful to them. I know the research ethics boards right across the country are beginning to talk about stem cells, they're beginning to talk to each other about it, they're beginning to read these guidelines, and they're beginning to get a degree of comfort that, yes, we can proceed with this kind of research now where perhaps we couldn't before.

In the commercial area, in industry, they are not confined to guidelines of the CIHR. They can do whatever they like. The good thing about the legislation is that, I presume, it pertains to everybody, whether you are a company or a CIHR-funded researcher. That's what I like about it, because frankly I think the situation in the United States is a bit ludicrous, where you have President Bush saying that you can only work with 60 cell lines if you're funded by the National Institutes of Health or any government body. Meanwhile, if you're funded by the Howard Hughes Institute for Medical Research, which is independent, then you can create cell lines as you like and hand them over to people who work with NIH money. I find the U.S. situation a bit untenable. I like what we're doing here better.

Dr. Michael Rudnicki: In answer to your question about research funds, if I understood the question right, the CIHR will not release funds until you have ethical proof. You need that certificate.

The Chair: Thank you, Madam Scherrer.

We'll go to Mr. Merrifield now.

Mr. Rob Merrifield (Yellowhead, Canadian Alliance): Thank you. I certainly appreciate the presentation.

Just going back to what was talked about a few minutes ago with regard to embryonic stem cell lines or research being done in Canada, you're suggesting to me that there is none done. Is that with federal funding or private or...?

Dr. Michael Rudnicki: I don't know of anyone who has derived human ES cells, either in the private or public sector in Canada. As far as I know, zero exist.

Mr. Rob Merrifield: As far as human embryonic research goes?

Dr. Michael Rudnicki: Correct.

Dr. Ronald Worton: There's a lot of work being done on mouse embryonic stem cells, and that has been going on for 15 years.

Mr. Rob Merrifield: Exactly.

I guess it disturbs me a little when we say that you're a little nervous because of the ethics, but if there is some legislation there and there are no ethics.... I understand full well where the Parkinson's group and the muscular dystrophy group would be coming from. You will look for an answer when you are in those situations, absolutely. I feel for you.

I guess my question concerns the dream that embryonic stem cells will be the cure. Yet is that just a dream and are we grasping at straws somewhat? What will become the cost of grasping at that straw?

I guess to the entire panel I would say I'm a little disappointed in your presentation because you came to us suggesting only the positives and only the most opportune things about using embryonic stem cells. You never shared with us any of the negatives, any of the problems of being too elastic as far as stem cell use goes or the problems of rejection potential with embryonic stem cells as compared with adult cells.

I wonder if you would comment on the rest of the story.

The Chair: Dr. Worton.

Dr. Ronald Worton: I did start out by saying that I did support the legislation in general in all its aspects and that I had some reservations about the permanence of classing certain things as being prohibited and therefore illegal. But I certainly agree there is a need for legislation, a need for regulation, and a need for a regulatory body to oversee it. The details of how that works with the research ethics board in local situations can be left for later, but certainly I agree that there needs to be this kind of regulation.

• 1235

I'm totally opposed, for example, to cloning people. I think it's dangerous. I think we're far from ready to do that. Personally, I hope it's never done. I would be totally opposed to it, therefore I'm glad to see it as one of the 11 prohibited activities.

I have dealt with, and thought a great deal about, some of the ethical issues. When it comes to using embryonic stem cells from a five-day embryo, it really depends on how you view that. One way of viewing it is that every five-day embryo has the capability for life, and that is true. But there's the other way of viewing it. For example, with therapeutic cloning, if we wanted to take cells from Claredon's bone marrow and use adult stem cells to repair his muscle, I would hope that would work. That's our long-term goal: to be able to repair his muscle with his own bone marrow stem cells.

But if that doesn't work very well, and it becomes clear five years down the road that the only way to do that efficiently and properly is to use embryonic cells, we may want to create what some people would call an embryo, to derive the cells to cure his disease.

The other way of thinking about it is that say we take a group of cells from Claredon. We take a nucleus and place it into an enucleated egg. In that environment, it will be reprogrammed so it has the capability to create embryonic stem cells. Then we use those cells. That's really what you're doing. You're taking a nucleus of a cell from him, putting it into a developing egg, created for that purpose, allowing it to grow for five days, and then collecting the stem cells.

It's so dependent on what your viewpoint is, whether you view this as a way of generating embryonic stem cells or whether you view it as the destruction of an embryo.

The Chair: One more, Mr. Merrifield. You are over five.

Mr. Rob Merrifield: Yes, we got just the one answer.

What disturbs me is that we are saying, well, let's open the floodgates and get really excited about the embryonic side of it, and yet you're suggesting that some of the greatest potential is in the adult. I would concur and agree with that. It disturbs me a little bit that if we open the embryonic we'll lose resources and funding for the advancement of the adult, where I think there is probably more potential, and for sure fewer ethical problems.

Dr. Ronald Worton: I completely agree that we don't want to go too far with this legislation and make it unpalatable to Canadians. I would totally agree that right now we should not be working with or creating embryos for research. We should not be creating embryos for the development of stem cells. We should not be doing therapeutic cloning. But it's hard to predict what the Canadian public will think ten years down the road, on the basis of research.

Mr. Rob Merrifield: That's true, but your argument is let's not prohibit it for the sake of five years down the road; we may want to do some research. I would say the other argument is we should go slow for fear of making a mistake. That's not part of the arguments I hear coming forward.

Dr. Ronald Worton: I could quite comfortably support this legislative package just as it is, including the prohibitions that exist, as long as there were a clear mechanism for reviewing it down the road. What I hear from some people—and this was brought to my attention mostly by Preston Manning, when he came to visit us to try to understand about stem cells—is that if the legislation has to be changed in order to do something that seems suitable down the road, it could take 15 or 20 years to change the legislation, whereas if a regulatory body can make that decision, it could take months rather than years.

Mr. Rob Merrifield: I've seen legislation happen in 72 hours around here.

Dr. Ronald Worton: I stand corrected.

The Chair: Thank you, Mr. Merrifield.

Mr. Charbonneau is next.

[Translation]

Mr. Yvon Charbonneau (Anjou—Rivières-des-Prairies, Lib.): Thank you, Madam Chair.

My question is going to round off the debate that has just begun; it has to do with paragraph 3(1)(b) of the draft legislation. That paragraph reads:

No person shall [...] alter the genome of a cell of a human being or in-vitro embryo such that the alteration is capable of being transmitted to its descendants;

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We know that some diseases are hereditary and others are not. I do not know for sure whether Parkinson's disease and muscular dystrophy are hereditary, but even if they are not, I know that other diseases are: heart disease, brain disease and other diseases.

If genome alterations could prevent such a disease from being passed on to future generations, would that not be a good thing to contemplate, whereas the draft legislation prohibits it? How do you feel about that? What do you consider to be the basis for a prohibition such as the one found in paragraph 3(1)(b), which prohibits transmissible alterations? This means that good or bad, for better or for worse, such alterations are not allowed. It seems to me that if it is for better, perhaps we should look into it. I would like to know what you think about that.

Mr. Yves Savoie: I am going to give you a general point of view on the issue, and perhaps Dr. Worton could discuss it in greater detail.

It goes back to the main theme of our presentation, which is to say that in order to change the prohibited activities and to accept the fact that research will enlighten us, it will take the parliamentary process a long time, whereas with a council responsible for monitoring and regulating those activities, and perhaps with moratoria under the legislation, it will be easier.

As for the technical question, I would prefer to turn it over to Dr. Worton.

[English]

Dr. Ronald Worton: I think the paragraph you refer to about altering the genome is a good one, and it should remain in there. I think this is designed to prevent tinkering with the human genome to create alterations in the genes, or mutations, if you like, that could be detrimental. I don't see any reason why we need to do that.

It is true that practically all forms of muscular dystrophy are inherited. They are passed from generation to generation. But the way of preventing that is not by trying to alter the human genome. There are other means, and we would rather treat the disease than try to interfere with the genome itself.

So I think that is a good part of the legislation. I wouldn't change that.

[Translation]

Mr. Claredon Robicheau: I would like to add something. We were talking about my brother at the beginning of our personal discussion and our discussion with the Muscular Dystrophy Association of Canada. There is a huge difference when I talk to my brother about altering the genome for the purpose of treatment and when we talk about playing around with genome and DNA to prevent his children from getting the disease. That is fooling around with humanity and its development. The first scenario is about treatment, the second is another matter altogether.

[English]

The Chair: Excuse me.

On a matter of process, Dr. Leroux, I cannot recognize a member of the panel unless one of the questioners asks you a question, or you jump in to comment on it.

Dr. Thérèse Leroux: I just wanted to remind you,

[Translation]

Mr. Charbonneau, may I suggest that you read about the ethics of research involving human beings in the Tri-Council Policy Statement. Chapter 8 deals with genetic alterations. You will see that behind all the talk, I think we have to come right out and admit we are spooked by eugenics. The idea that gene therapy could be used to change an individual's genetic potential for purposes other than positive ones like improving a person's health and that of his or her descendants, has led to the conclusion, in that policy statement and elsewhere, that this kind of genetic alteration is unacceptable. I think that this is what is behind the position that has been taken.

If we look back at documents like those that were drafted by the Royal Commission on New Reproductive Technologies, we will find the same prohibition. So I think it is like an extension of that logic. Perhaps this can be reconsidered in the future, because we have been told that the act could be reviewed every five years, and perhaps we will have changed our position. But I believe that given the current state of our knowledge and given that we do not know the medium- and long-term repercussions of gene therapy on sex cells, we are not in favour of such a thing.

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[English]

The Chair: Thank you.

I'm sorry, did I interrupt you, Dr. Rudnicki?

Dr. Michael Rudnicki: That's okay.

The Chair: We'll now move on to Mr. Lunney.

Mr. James Lunney (Nanaimo—Alberni, Canadian Alliance): Madam Chair, I first of all would like to thank all of the witnesses for their contribution to this very interesting and challenging area we're looking into.

I would also recognize Dr. Worton and Dr. Rudnicki. I had the privilege of visiting their research institute with Preston Manning and others from our caucus earlier in the year. I was very thoroughly impressed with the facility and the quality of activity already underway, and the very comprehensive equipment and degree of research going on already. In fact, I'll never forget looking through a microscope and seeing these stem cells growing in a Petri dish, actually seeing muscle cells beating there rhythmically.

But I would like to say something with regard to the stem cell lines being discussed here and the 60 lines in the United States, and the matter of keeping these cells growing. As we look around the room here, each of us have in us somewhere between 80 trillion and 100 trillion cells, I suppose, and we all contain stem cells. Would it not be possible with a little bit of further research to cultivate adult stem cells in the same way, in vitro, and develop further lines infinitely this way?

The Chair: Dr. Rudnicki.

Dr. Michael Rudnicki: That is indeed within the realm of possibility, but up to today people have not been able to grow these cells at all in tissue culture, and we have long experience with bone marrow stem cells. We can grow them in complex cultures for a short period of time, a few weeks, maybe a few months if we really push it, but they cannot be grown as pure populations and to increase the numbers at all in Petri dishes. ES cells, however, can. You can grow pounds of ES cells in incubators under pretty simple tissue culture conditions as relatively pure populations in the Petri dish.

What one can do also from ES cells is to differentiate them in tissue culture and derive adult stem cells from those ES cells to reconstitute the bone marrow, or repair muscle or produce neurons for a Parkinson's patient, from stem cells, from an adult stem cell that's derived from an ES cell.

So we really can't predict which will be the best way to proceed and which cells will be most useful in a clinic. We really need to study all of these in basic research to understand how they function and what makes them tick

Mr. James Lunney: Yes. Of course, if the adult cells were taken from the Parkinson's sufferer himself, then you wouldn't have to grow them for a long period of time and you'd be able to reintroduce them to the patient. You wouldn't have to grow them indefinitely.

Dr. Michael Rudnicki: But getting enough numbers is a real problem.

Dr. Ronald Worton: I think what you're suggesting is absolutely what we would like to do, and I think I said that in my presentation. We would love to be able to use adult stem cells exclusively to treat a lot of these diseases. That would avoid the necessity of us ever needing to work with embryonic stem cells for therapeutics.

The problem is, I think, to get there we need to be able to study the embryonic stem cells and the adult stem cells and compare them and try to figure out what the differences are. What are the different genes that are turned on, for example, in an embryonic stem cell, that are not turned on in an adult stem cell?

If we knew that, and we knew which genes were responsible for giving an embryonic stem cell its wonderful properties, then we might be able to turn those genes on in an adult stem cell or introduce the genes through a virus or something like that into the adult stem cells and basically convert them into an embryonic-like stem cell so that they could work their magic.

That's what we'd like to be able to do. We're talking here about a period of research for the next five to twenty years in which the only way I think we are going to be able to do that and maximize the use of adult stem cells is to really understand those differences and apply them.

Mr. James Lunney: I have a comment on the Parkinson's, and then I'd like to ask a question on the chimera that you introduced earlier. On the Parkinson's, has anybody attempted adult...? First of all, we know there have been disastrous consequences from trying to introduce embryonic stem cells to Parkinson's patients at this point in time. Some led to uncontrolled tremors that were far worse than what they had as Parkinson's patients. In fact, it seems to me that I was told by one researcher that embryonic cells, because of the immuno-unique character of the brain, the blood-brain barrier, without the suppression of immune cells would grow so aggressively they would kill the patient, frankly.

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Is anybody working with adults, or has anybody tried to use adult stem cells at this point in time with Parkinson's patients?

Ms. Mary Jardine: That's a good question, and I don't know the specific answer to that. I know there have been some real challenges and problems with the fetal cell transplants, but in terms of the embryonic stem cells....

I don't know, Dr. Worton, whether you would have any insight into that. I honestly don't know the answer, although I can find out.

The Chair: Dr. Worton or Dr. Rudnicki.

Dr. Michael Rudnicki: You asked about adult stem cells to treat Parkinson's, is that right?

Mr. James Lunney: Yes.

Dr. Michael Rudnicki: To date, the best work is in mice. There are bone marrow transplants. If you conduct a bone marrow transplant on a mouse, you can find that those donor cells have found their way throughout the brain of those little patients. It's reasonable to predict that this might also work in humans, but we're still at the research stage. That kind of study is just beginning to look at humans to see whether, retrospectively, patients who have received bone marrow transplants, for example, might have contribution of the donor cells in the brain.

Mr. James Lunney: Well, that sounds very exciting.

My final question has to do with your comment, Dr. Worton, I believe, about using somatic cell hybrids. We've been asking the Health Canada experts to shed some light on why anyone would want to mix animal and human genes, and I see here that you've mentioned that they were used for examining gene expression. Could you develop that a little for us? We've been looking for some information.

Dr. Ronald Worton: There are two things. One is mixing human genes and mouse genes at the level of creating an embryo. You don't want to do that.

What has been done for the last 30 years is that if you take a mouse cell growing in culture and a human cell growing in culture and fuse them together, they form a hybrid cell. The hybrid cell, generally speaking, loses its human chromosomes, but it loses them slowly over a period of time. Ever since 1970, people have taken advantage of that to map human genes, because as these hybrid cells lose their human chromosomes as a natural consequence of their continued growth, they lose their human genes, and you can correlate which chromosomes are lost with which genes are lost and therefore determine which genes are on which chromosomes.

That has been done for 30 years. It has been done in hundreds of labs, and it has been done throughout the world. It's non-controversial, essentially. You're talking about cell lines—not animals, not people, but simply cell lines. They've never been referred to as chimeras, because chimeras would be more creating a chimeric organism; these are simply cell lines.

The other place where human genes are in fact introduced into mouse cells on occasion is to look at what are called transgenic mice, where you put in a foreign gene, and sometimes those foreign genes are from other mice. Sometimes they're from other organisms. Sometimes they're from humans. The question that's usually being asked there is how is that human gene regulated, and what is the function of the gene? You can't put the gene into another human to test what it does, but if you put it into a mouse, you then can determine what the function of this gene is.

That's being done. It has been done routinely for the last ten years or so, but we're talking about one gene from a human into a background of mouse genes. We're still talking about a normal mouse for all practical purposes, but it tells you a lot about what the human gene is capable of doing.

That's being used in gene therapy testing, to ask, for example, if you have a mouse with muscular dystrophy, can you rescue that by putting in a normal human gene, just different? That's one way of answering that question. It does no harm.

Mr. James Lunney: I think the concern in legislation with such a critter is that somebody could start developing these a little further to try to bring something to birth that's part human, part something else. How do you control that one?

Dr. Ronald Worton: I think you control it with the procedures that we've been talking about putting into place. The regulatory body will have a mixture of smart people from all walks of life, including scientists, and they easily should be able to make the distinctions between what makes good sense and what exceeds the boundary of common sense.

The Chair: Thank you, Dr. Lunney.

Mr. James Lunney: Thank you, Madam Chair.

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The Chair: Mr. Castonguay.

[Translation]

Mr. Jeannot Castonguay (Madawaska—Restigouche, Lib.): Thank you, Madam Chair.

Thank you to our guests, who are a great help to us, but who sometimes complicate matters for us. Obviously, we hear a lot of evidence. The spectrum is broad, and broadens by the day, because some people are completely opposed to any research in this field. I highly appreciated your presentations.

Traditionally, as we all know, everyone used to agree that when you put an egg together with a sperm, you created an embryo.

Technological advances now make it possible to take an egg, change its nucleus and obtain tissues that are clearly genetic material with great potential. Has an embryo been created or not? That is a very tricky area in our discussions with people who are completely opposed to interference with embryos.

I would like your opinion. Is it truly and embryo or just cells with great potential? Do we have to consider that an individual could be created by putting those cells in a suitable environment, or are they just cells with enormous potential? I would like your comments.

Do you understand my question?

Ms. Thérèse Leroux: I think so. I think you would have to ask scientists what it is about an embryo that makes it different from a mere cluster of cells with great research potential. Is the mere union of egg and sperm, with the potential to develop a new and distinct person, what makes us say it is an embryo? If you take genetic material from a somatic skin cell and put it in an egg, that changes the ground rules. Can you still call it an embryo? I do not know whether my scientist colleagues can actually tell us whether there is truly a definition of an embryo.

[English]

Dr. Ronald Worton: Perhaps I can refer that to Dr. Rudnicki.

Dr. Michael Rudnicki: I think this becomes largely an issue of semantics. What is an embryo? Well, first of all, a blastocystic-stage embryo, which has about 64 cells, of which 12 or so are embryonic stem cells, has zero chance to form a life unless it implants into the womb. It has as much chance as a hair follicle from my head. It is not a person. It has a potential to become life, but for that matter, so does every cell from my body if you think nuclear cloning might some day have those problems solved.

It deserves the respect and treatment with due regulation because of its source, but we have already as a society crossed that moral bridge because of what goes on today and in the last 20 years in IVF clinics. People donate sperm and ova to create embryos in the Petri dish. Of those embryos, the best-looking ones that are fertilized and that grow into nice healthy-looking blastocysts, two will be implanted into the mother, and on average one of those will be born. The remainder of those embryos that are sitting in the dish will either be frozen for future use, discarded, or used for research to improve the IVF technique. We have already crossed that bridge.

Is a blastocyst, or a fertilized zygote, for that matter, an embryo? Yes, it is. Does it have the potential to form a life? Only following implantation into the womb. Before that, I would take perhaps the view that it is a group of cells—a group of special cells that require due respect and a regulatory framework to work with them—but they are not the same as a 24-week fetus. That's my view.

[Translation]

Mr. Jeannot Castonguay: Thank you. I understand completely.

When we talk about semantics, that is perhaps the problem when dealing with people on the street who say not to interfere with embryos. To them, an embryo is an egg that has been fertilized by a sperm. But when the nucleus of a somatic cell is inserted into an egg, is that an embryo? It may be semantics, but it is important for us to know what that is.

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We know how much potential it has, but the fact remains that to begin with, it is not the same exercise.

[English]

The Chair: Do you want someone to comment, Dr. Castonguay?

Mr. Jeannot Castonguay: Yes. From the ethical point of view, I would like to hear what....

[Translation]

Ms. Thérèse Leroux: From the ethical point of view, you may well find it helpful to consider whether your approach focuses on the end purpose of the activities undertaken. Or do you have a utilitarian approach? When the nucleus of an egg is removed, and the nucleus of a somatic cell is inserted in order to do research, it is argued in that case that the end purpose is such that there is no interest in creating a new human being, but only in having research material, and that therefore the end purpose is limited and very specific.

However, I am sure that among those whom you meet on the sidewalk and who ask you questions, some have an ethics-based approach. They do not feel that the end justifies the means. They say that once there is potential life, the material cannot be used. That potential gives the material a unique characteristic. Because they fear that it is a slippery slope that will get out of control, they tell you it is because the material has too much potential and they do not want it used for those purposes.

Such matters are never black and white. A good lawyer will always come up with arguments for or against, regardless of what position you want to take.

I am sorry I cannot answer your question. It is a good question, but I am unable to answer it. Once again, I am probably going to have to ask someone from the scientific community to give you a precise explanation. When it comes to ethics, I can come up with arguments in support of the position that those cells still have characteristics unique to embryos, as well as the opposing position that when you consider the end purpose, those cells are no longer in the embryo category.

Mr. Jeannot Castonguay: Thank you.

[English]

The Chair: Thank you, Dr. Castonguay.

You have another comment, Dr. Worton?

Dr. Ronald Worton: Madam Chair, I have nothing to add to that statement. I think that was a good summary. I'm embarrassed to say that I'm a little late for a meeting with the Deputy Minister of Health and one of the senators to talk about another issue, and I wonder if I could be excused. I think there's enough expertise at the table.

The Chair: Yes. Thanks very much.

Dr. Ronald Worton: Thank you very much.

The Chair: I just want to summarize. I want the people here who are visiting us, who have strong points of view, to understand the conundrum we face. I notice a tremendous spectrum of cooperation with the government involving you and other groups we've had.

For example, you said that in the absence of legislation and without the approval of a hospital ethics board, which might also be tied to government funding, scientists hesitate to act. But we've had testimony that assisted human reproduction using surrogate mothers has been going on and making money over the six years we've had a moratorium. So we have people who are acting in the face of a moratorium, just totally disregarding it. And then over at the other end of the spectrum, we have you hesitating to act because you don't have firm guidelines, legislation, or whatever.

Of course, I consider the scientific behaviour to be highly ethical and the behaviour at the other end of the spectrum to be not ethical. We have to somehow come up with legislation on assisted human reproduction that addresses both ends of that spectrum.

As one more point, I noticed that Dr. Leroux said the ethical position that's going to be endorsed by the CIHR isn't yet ready. Yet I noticed the two groups that came to talk about their groups' positions all said they were leaning on or agreed with the position put out by the CIHR.

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The fact is, there isn't one. Your presentation to us, as the only ethicist who attended today, shows that. You simply talked about process, about how it's going to work, and then raised ethical questions. But we need the answers. We need some kind of an answer.

We have had ethicists here who have stuck their necks out and said they thought this was an issue, and that was a problem, and this was good, and this wasn't good. But I feel you have a particular position, being with the CIHR, when all these groups are saying, we agree with the basic principles laid out by the CIHR.

So when do you think we could expect this? I don't mean a statement of policy, I mean the agreed-upon ethical position you alluded to you in your speech. When are we going to get that? Or when are they going to get it? Because they're saying they agree with something that isn't yet published.

Dr. Thérèse Leroux: Yes, it is. Well, they agree with our discussion paper, which presents recommendations and our point of view.

The Chair: Yes, about what should be allowed, but there's no ethical explanation for all that. I thought you said there's a paper coming that's strictly on the ethics of the issue.

Dr. Thérèse Leroux: Yes, it will be the final report, based on this discussion paper and on remarks and comments we've received from people who send us letters to our website. So we will be adding to this, and we may change some of our recommendations.

The Chair: What do you predict? Will you be changing anything? Do you predict that? I just ask you to stick your neck out a bit. Is it going to be pretty well the same thing, so that these people are safe to say they agree with it and support it, or is it going to be different in three weeks?

Dr. Thérèse Leroux: It won't be different in principle, but we may add some more information to guide the researchers and the ethics review board. So they will find a complement in this, because people were asking questions. They need to have more information.

In this document, for example, we didn't look very closely at the use of tissue coming from outside Canada. So now, in our next document, we will add this information, because the ethics review board will have to look at protocols where the investigator will say, a member of a group and one of my colleagues is working—let's say—in the United States, can I share his cell lines. We will try to help the board by giving them insight as to how to look at this type of protocol. Then, because there was new development using umbilical cord stem cells, it might be interesting to say in this case who will give consent. It's not necessarily clear in this case. So that will be added.

But I think the principles are already in this. It's like an instrument to help to follow this document, where you have the foundation of how we think about human research.

We are still working. We'll have a conference call at the beginning of October. We wish to have completed our work for November. As soon as we have this final report, it will be our pleasure to send a copy to you and to all the members of this committee.

The Chair: Thank you very much.

Thank you, everyone. I just didn't want anybody to leave without understanding the ethical conundrum we are in, considering the behaviour of people who are in the field of assisted human reproduction.

Thank you very much for sharing your wisdom with us and your experience. We very much enjoyed it.

The meeting is adjourned.