Health Committee on Nov. 23rd, 2010

[Dr. Donna Wall]

Thank you very much, Madam Chair and committee. I'll be brief.

I'm speaking as a pediatric blood and marrow transplant physician who uses cord blood as the primary choice of stem cells for transplant in children who do not have a donor in the family, and also as a person who's been active in the field of cord blood banking and regulation for over 15 years, having started both the St. Louis Cord Blood Bank and the Texas Cord Blood Bank, and being active in the Foundation for the Accreditation of Cellular Therapy.

My previous colleagues have made a very eloquent case for the need for a cord blood banking system in Canada. The points I'd like to accentuate at this time are as follows.

One, a cord blood bank in Canada needs to be known for its quality. There are very strict international regulatory standards that have been established, and it's critical that we be known as a bank with very high standards.

Second, just to be very direct, size matters. When we're doing a transplant, we need to have a large cord blood unit, meaning units that have the most cells possible contained in them. What that means in banking operations is that you need to develop a collection network and system that allows you to bank only the largest of the cord blood units.

The third point is that it is critical to have a variety of immune types--and you can put in the word “ethnicity”, since immune type and ethnicity go together. Where cord blood makes a difference in clinical practice is with our patients who are of mixed racial heritage or of ethnic minorities. With the establishment of a bank, we need to unabashedly target these populations for the bank. This means our first-generation Canadians, our multi-ethnic Canadians, and ethnic minorities. This is going to need a very creative network of cord blood collection.

We have a lot of the building blocks in place for an excellent cord blood collection banking system in Canada. We've heard from CBS. It has set up a tremendous network system for management of donors, putting transplant centres across the world together with donors across the world. There's no need to reinvent the wheel in that department. We have Héma-Québec, which has done a tremendous job in setting up a solid cord blood bank, as have colleagues in Alberta.

What we need are the funds to help pull all this together and take the banking operations up to the next level so that we can move to the forefront on the world stage. I've inspected banks around the world. Unfortunately, I have never had the privilege of inspecting a Canadian cord blood bank as part of the international accreditations, because we're just not quite there yet.

With those words, I'll submit my written document. I don't want to waste everyone's time by repeating a lot of the similar statements.

Thank you for the time.

[The Chair, Conservative, Joy Smith]

Thank you very much, Dr. Wall, for your insightful comments. They're very much appreciated.

Last but not least, from the Department of Health we have Liz Anne Gillham-Eisen, who is the manager. Would you present your document, please?

[Liz Anne Gillham-Eisen]

Thank you very much, Madam Chair. I'd like to thank the chair and this committee for the opportunity to address you this morning--almost afternoon.

I'm here representing Health Canada. I've been asked to explain Health Canada's regulatory requirements with regard to cord blood banking. This is probably the boring side of the discussion. You've heard the very inspirational, and the need, and how important cord blood banking is in Canada, and I am very privileged to be sitting here with these individuals.

My presentation, again, is on the regulatory side. First of all, I'd like to take a minute to explain, in general, how the safety of stem cells is regulated in Canada. I was present at your initial hearings on stem cell donation, which you held on November 2, I believe, and I think there may be some confusion around the regulatory oversight of stem cell therapies.

Stem cells, as you know and as you've heard, can be produced from a variety of sources, including embryos, bone marrow, cord blood, adult skin, peripheral blood, etc. The Assisted Human Reproduction Act contains provisions governing the creation of embryos, including their use in research. In order to use stem cells derived from embryos for research, a facility will need to be licensed under Assisted Human Reproduction Canada, which, as you know, is the agency responsible for the AHR Act.

However, once a stem cell line has been established from an embryo, any clinical trials for new therapies using this stem cell line are subject to the requirements of the Food and Drugs Act and regulations, specifically division 5, which regulates the clinical trials and clinical trial applications.

Research involving stem cells sourced from other sources, such as cord blood and bone marrow, does not fall under the AHR Act. This research is subject only to the requirements of the Food and Drugs Act and regulations. There is also the Canadian Institutes for Health Research, which has developed guidance and created a national stem cell oversight committee to address all stem cells used in research.

Now I'd like to specifically speak to cord blood, which, as you've heard, is the blood that remains in the umbilical cord after birth. The retrieval of cord blood allows for the harvesting of stem cells, which can then be transplanted into patients to treat a variety of disorders, such as certain cancers and genetic diseases related to blood and blood cell formation.

Stem cells retrieved from cord blood may be transplanted into the same individual, which is considered autologous use, or into another individual, which is referred to as allogeneic use, provided the cells and the recipient are sufficiently matched.

Cord blood banking is the act of storing cord blood under controlled conditions for future use. Current technology enables storage of cord blood for many years. Public cord blood banks, for example, the Alberta program, as well as Héma-Québec, collect and store donated cord blood for use by unrelated patients. Information needed for matching can be listed on a registry so that this cord blood can be used to save the life of a potential recipient in Canada or elsewhere in the world.

Private cord blood banks collect and store babies' cord blood in return for a fee. Cord blood is banked for either autologous use, which is for that child himself or herself, or for allogeneic use, normally restricted to another family member.

Health Canada's role relating to cord blood pertains to the safety of the human cells derived from the umbilical cords that are used, or intended for use, in transplantation. Both public and private cord blood banks fall under the same set of regulations.

Cord blood is currently classified under the group of products known as cells, tissues, and organs, or CTOs. CTOs are considered to be therapeutic products, and as such they are subject to the provisions of the Food and Drugs Act. The act prohibits anyone from distributing cord blood, or its cells, if it has been prepared or collected under unsanitary conditions, is adulterated, or is likely to cause harm. Health Canada has the authority to enter cord blood facilities for investigational purposes and to stop distribution if necessary.

In December 2007, specific regulations for transplantation that apply to cord blood as well as other types of cells, tissues, and organs came into force. These regulations reference portions of the national standards for cells, tissues, and organs published by the Canadian Standards Association and funded by Health Canada. Cord blood establishments involved in the retrieval, processing, preservation, packaging, labelling, storage, quarantine, record-keeping, distribution, importation, adverse event reporting, investigation, and recall of cord blood for allogeneic use are required to comply with these regulations.

These cord blood banks are also required to register with Health Canada, and cord blood for allogeneic use can only be collected, stored, and distributed for use by banks with a valid Health Canada registration. If cord blood is used for a novel or experimental purpose, or extensively altered or manipulated prior to its use, other regulations under the Food and Drugs Act may also apply.

There are two public cord banks in Canada, and you've heard presentations from both of them, and there are ten private cord blood banks registered with Health Canada. The Health Products and Food Branch Inspectorate is in the process of inspecting these establishments to assess their compliance with the CTO regulations. As of today, one-third of the cord blood banks have been inspected, and Héma-Québec is one of them that has been inspected. All have received compliant ratings. The inspections of all registered Canadian CTO establishments, including the cord blood banks, should be completed by the end of next year. December 2011 is our goal.

As you are aware, both the Government of Canada and Canada's provincial and territorial governments have responsibilities in the area of health care. Delivery of health care, including the supply and sourcing of products used in the provision of health service, is a provincial responsibility and beyond federal authorities, with some exceptions. As such, the establishment of a national cord blood bank would have to be initiated and coordinated by provincial and territorial governments, despite the national scope.

Health Canada is aware that in 2007 the provincial and territorial ministers of health had asked Canadian Blood Services to study the feasibility of creating a national cord blood bank, and CBS concluded that Canada should have a national public umbilical cord bank, and you heard the results of that particular consultation from Dr. Sher.

I'd like to thank you once again for the opportunity to explain Health Canada's regulatory role with regard to cord blood banking and to clarify the federal regulatory oversight with regard to stem cell therapies.

Thank you.

[The Chair, Conservative, Joy Smith]

Thank you very much.

Now we have the opportunity to question our guests. For the first round, each individual will have a seven-minute question and answer period. I will be watching the time carefully.

First we'll begin with Mr. Dosanjh and Dr. Duncan, who are sharing their time.

[Ujjal Dosanjh, Liberal, Vancouver South, BC]

Thank you very much for being here and talking to us.

I have a very general and brief question. There is a perception that in Canada researchers face some obstacles in stem cell research, and I understand there were guidelines back in June of 2007 by the Canadian Institutes of Health Research. One of the guiding principles outlaws the creation of embryos for research purposes by anyone obtaining federal funding. Now much of the research in this country doesn't go very far without federal funding. So the question I have is—anyone can answer it—does this create a problem in terms of wide-ranging research that scientists usually like to conduct?

[The Chair, Conservative, Joy Smith]

Who would like to take that?

Dr. Sher.

[Dr. Graham Sher]

Madam Chair, I'll provide a very brief answer, and colleagues can add to it.

Mr. Dosanjh, the issue you're raising is of course related to embryonic stem cell research, and as Liz Anne just pointed out, what we're talking about here are mature stem cells found in blood or cord blood, which are not embryonic in nature. So the guidelines that you refer to are slightly different.

[Ujjal Dosanjh, Liberal, Vancouver South, BC]

I recognize that. We're talking here about a cord blood bank, a national blood bank. I think there's pretty well consensus on that. That's motherhood today. That's why I'm asking you the more important question in terms of the research.

[Dr. Graham Sher]

My second quick comment to your question is yes, the plan that we have put forward to the provinces and territories contemplates the national bank being able to support research into stem cell biology. Currently there are many researchers trying to access cord bloods in this country for research purposes. Most of that is not acquired through cord blood banks but is really acquired directly from obstetric and gynecology delivery units. But we are certainly building into our plan the capacity to support the research community within the research guidelines, and any cord blood samples collected that are not suitable for storage and transplantation would be made available to researchers in an equitable and fair fashion.

[The Chair, Conservative, Joy Smith]

Dr. Duncan.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

Thank you, Madam Chair.

Thank you to the witnesses for coming. I just want to begin by saying I strongly believe that stem cell therapies represent a tremendous opportunity to improve or alleviate human suffering, reduce the economic burden on health care costs to Canadians, and create long-term jobs in the delivery of generic medicine. I also want to recognize that Canada really has global scientific leadership in this field, and I think we have to ensure that Canadians benefit from this discovery and have access to these therapies in a safe, fair, and timely manner.

I think we know the answers to many of these questions, but I would like your opinions. Do you think Health Canada should be asked to review its guidance for clinical trials relating to cellular therapy to ensure that Canadians will be able to access stem cell therapies in a safe and timely manner?

[The Chair, Conservative, Joy Smith]

Who would like to take that on?

Mr. Lebrun.

[Dr. André Lebrun, Vice-President, Medical Affairs, Hematology, Héma-Québec]

First, I would like to respond to the first question that was asked regarding Canada's involvement in stem cell research. Since the very beginning, Héma-Québec has said that we should support that kind of research, and that is what we have been doing since 2004. We have put 4,000 units in the bank, but nearly 10,000 others could not be added to the inventory and were made available to researchers. We work with five research centres in this area.

As for the regulations you referred to, you have the clinical component and the practical one. We are not directly involved in the clinical side. But clearly, we would like to see certain regulations relaxed, so that we, as cord blood suppliers, could improve our inventory, especially with respect to its ethnic diversity.

You are no doubt aware that there are many genetic differences between ethnic groups, and it can be hard to recruit people who do not meet the basic criteria, such as those governing hemoglobin or sometimes even exposure to malaria or HIV Group O, in certain African nations. Some criteria such as those should be improved, so that we can further develop our public bank.

We have talked a lot about the need to recruit donors from different ethnic groups. For example, according to figures put out by the New York Blood Center's National Cord Blood Program, even though just 9% of blood is donated by people of Asian ethnicity, there is compatibility with 50% of donors.

[The Chair, Conservative, Joy Smith]

Thank you. Can I just interrupt you for a minute, because I believe Liz wanted to make a comment too?

Okay, Liz, go ahead.

[Liz Anne Gillham-Eisen]

Sorry, this is just to clarify that as far as the guidance is concerned in developing around research and clinical trials, etc., that do exist, they do fall under division 5 and there is guidance. There is a working group in place to develop specific guidance for clinical trials around stem cell therapies. There's also a workshop that is occurring in December of this year dealing specifically with research in stem cells, entering into clinical trials, trying to make that easier, and that workshop is happening in Canada. There's another international workshop that is going on.

Did you want me to address the ethnic--

[The Chair, Conservative, Joy Smith]

No, not right now.

We have to stop, Dr. Duncan.

Dr. Akabutu, you wanted to comment on the same....

[Dr. John Akabutu]

I just wanted to observe that Dr. Duncan's question is very important.

[The Chair, Conservative, Joy Smith]

Yes, go ahead.

[Dr. John Akabutu]

If you look at all the research that's being done in the world today on stem cells, there's almost zero in Canada, which is nothing to be proud of. The problem we have in Canada is we all have the consensus that stem cell therapy is okay and let's do it, but nobody does it.

[The Chair, Conservative, Joy Smith]

I'm sorry, in this round I have to be a little tighter on time. I do have to suspend at a quarter to one because there are two motions on the table. I was extremely generous before; this time I have to be tighter on time. My apologies.

We'll now go to Monsieur Malo.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Thank you very much, Madam Chair.

During her presentation, Dr. Wall said that unfortunately no Canadian banks had obtained international accreditation. And yet Héma-Québec operates on the international stage. How can it do that without international accreditation?

[Marco Décelles]

I will give you a very simple answer. We are working on it. In February 2011, we will be submitting our application for international accreditation. I will spare you the logistical details associated with that, but there was a lot of work we had to do internally.

Regardless, as I mentioned earlier, an inventory has to have a certain number of units before a bank can be considered at the international level. Whether you are accredited or not, if you have not done the initial groundwork, no one will seek out your services. We had to prove ourselves at home first, and now we are ready to do so on the world stage. It will happen in a few months' time.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Congratulations.

You also said, during your presentation, that you were already active in other provinces in terms of providing other types of services. How were you able to start operating outside Quebec?

[Marco Décelles]

It is demand, plain and simple. The human tissue sector is quite different, and we are just as used to providing that service as Canadian Blood Services. We operate in an open market, meaning a competitive one, so we are competing against the Americans, among others. In that kind of environment, we have to set ourselves apart, especially when it comes to product quality, reputation and quality assurance regulations. And that is why doctors elsewhere in Canada seek out our products and services.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Does it work the same way with cord blood?