Proceedings of the Standing Senate Committee on
Social Affairs, Science and Technology
Issue No. 54 - Evidence - February 28, 2019
OTTAWA, Thursday, February 28, 2019
The Standing Senate Committee on Social Affairs, Science and Technology, to which was referred Bill S-252, Voluntary Blood Donations Act (An Act to amend the Blood Regulations), met this day at 10:30 a.m. to give consideration to the bill.
Senator Chantal Petitclerc (Chair) in the chair.
[English]
The Chair: Good morning.
Welcome to the Standing Senate Committee on Social Affairs, Science and Technology.
[Translation]
My name is Chantal Petitclerc, and I am a senator from Quebec. I’m pleased to be chairing today’s meeting.
[English]
Before we give the floor to our witness, I would like to invite my colleagues to please introduce themselves.
Senator Seidman: Judith Seidman, Quebec.
Senator Eaton: Nicky Eaton, Ontario.
Senator Ravalia: Mohamed Ravalia, Newfoundland and Labrador.
Senator Oh: Victor Oh, Ontario.
[Translation]
Senator Mégie: I am Marie-Françoise Mégie from Quebec.
[English]
Senator Dasko: Donna Dasko, Ontario.
Senator Francis: Brian Francis, Prince Edward Island.
Senator Omidvar: Ratna Omidvar, Ontario.
Senator Moodie: Rosemary Moodie, Ontario.
Senator M. Deacon: Marty Deacon, Ontario.
[Translation]
The Chair: Thank you very much.
Today, we are continuing our study of Bill S-252, Voluntary Blood Donations Act (An Act to Amend the Blood Regulations).
[English]
To begin our meeting, I will ask our witnesses to start with their presentations. You have seven minutes for your opening statements followed by questions. We have today a witness by video conference.
We will suspend the meeting for five minutes about halfway through.
[Translation]
With us today from the Canadian Health Coalition are Melanie Benard, National Director of Policy and Advocacy, and Michèle Brill-Edwards, Board Member, as well as Curtis Brandell, President, British Columbia Chapter, Canadian Hemophilia Society. Joining us by video conference, we have Biba Tinga, President of the Sickle Cell Disease Association of Canada. Ms. Tinga, you may go ahead.
Biba Tinga, President, Sickle Cell Disease Association of Canada: Thank you, Madam Chair. Good morning everyone. My name is Biba Tinga, and I am the president of the Sickle Cell Disease Association of Canada, or SCDAC for short. Our organization is here today as a member of the Network of Rare Blood Disorder Organizations, or NRBDO. Once again, thank you for inviting us to appear before the committee and, above all, for giving us the opportunity to share our views on Bill S-252.
Sickle cell disease, or sickle cell anemia, is a genetic blood disorder that impacts more than 5,000 people in Canada. The disorder affects the production of hemoglobin, and, in order to survive, patients rely on donations of whole blood. I can speak to that from personal experience, as the mother of a young adult with sickle cell anemia. Blood donations are his only avenue for treatment and survival.
I’d like to make clear that our association has no conflict of interest. We have not received any funding or compensation from companies involved in paid plasma collection, nor will we. We are here simply to share our point of view.
To begin with, we consider the wording of Bill S-252 to be confusing, because it implies that blood donation is in question, and that is misleading to the public. Blood donations are still volunteer-based. This is about compensation for plasma donation, a model already in place in the United States. In our view, the main purpose of such a model is to reach collection targets.
Second, we believe financial compensation poses no risk to the public. The suggestion that compensated plasma collection could have a negative impact on non-compensated collection reveals a lack of understanding of the motivations of donors overall, including the young generation. Young people and the social media generation have a great sense of fairness and social justice and will no doubt challenge the purchase and use of products collected from paid donors in the U.S. and the reluctance to make that option available in Canada.
With that in mind, it’s important to ask the following question: If paying donors is morally wrong, is it right to compensate all those involved in the production chain? Canada would do well to adopt the plasma collection approach used in the U.S. because it has allowed that country to meet its demand. When it comes to compensating donors for their time or covering their transportation costs, we can firmly say from experience that paid plasma collection is only one incentive and does not impede overall collection.
For Canadian Blood Services and Héma-Québec, the impediments to meeting collection targets are altogether different. What we should actually be doing is welcoming these young people to donation centres, educating them and helping to build the volunteer culture that defines us.
We urge the committee to oppose Bill S-252, leaving the door open for the compensated collection of plasma and allowing Canada to have a full toolbox of options when it comes to increasing our self-sufficiency as it relates to this crucial ingredient for plasma-derived medicinal products. Thank you.
[English]
Curtis Brandell, President, Canadian Hemophilia Society, British Columbia Chapter: Good morning. Thank you for the invitation today. I am the President of the B.C. chapter of the Canadian Hemophilia Society and have lived with severe hemophilia since birth. I am here to voice our support for Bill S-252, the voluntary blood donations bill. Our members all know somebody affected by Canada’s worst blood disaster, spreading HIV and hep C to our friends and family. We are determined not to let that happen again.
Our chapter has had many concerns about allowing paid plasma collection centres to open across Canada. It has been very difficult for my organization to get a clear understanding as to why Health Canada has approved licences to Canadian Plasma Resources. There is no shortage now or in the foreseeable future to warrant a consideration for privatizing plasma collection in Canada.
I was disappointed to hear patient groups sounding the alarm about impending supply shortages if we stopped paid plasma in Canada. Our own national executive director of the Canadian Hemophilia Society publicly proclaimed that in 2013, that:
. . . if paid donors were to be stopped overnight, within months there would be, you know, hundreds of people here in Quebec, thousands in Canada, and hundreds of thousands around the world that would become sick and die.
Our board had not voted on a policy on this matter prior to our executive director taking this position publicly. When the CHS did vote on this policy position, our position on the vote was split. Out of the 12 directors, only six voted in favour of the motion to support paid plasma. The most populous provinces voted no. B.C., Alberta, and Ontario all voted against this policy, the same provinces that have since passed legislation to prohibit paid donation. With the vast majority of people in Canada unable to donate to a private company, where are these shortages that were imminent in 2013?
I believe it is extremely unfair that patients have not been correctly informed that paid plasma in Canada will not secure domestic supply. I believe that CBS and Health Canada should be doing a better job at stating this fact.
When I was asked to give testimony on the expert panel on immune globulin product supply and related impacts in Canada for Health Canada, I was presenting with many other patient groups. When the group was asked, at any time has any one of your members been unable to access medication, the response was a unanimous no. None of this discussion or any of my testimony made it into the final draft of the report. No discussion came on exploring Krever’s principle that paying for plasma should only be considered in rare exceptional circumstances. I found the process and approach to this expert panel deeply flawed; especially if the views voiced did not align with Health Canada’s position on paid plasma.
Patients in B.C. are most concerned about this situation from a federal point of view, as we are not self-sufficient in fresh blood or plasma. We rely on other provinces to cover the 10 to 15 per cent shortfall.
In our national policy on paid plasma donations, there is a provision that states, “any endeavour to collect plasma from paid donors must not affect the ability of CBS to meet the need for fresh blood components.”
When our chapter publicly voiced our concern about this shortfall of whole blood and support from a legislative ban in B.C., our chapter of the CHS lost its funding as a punishment.
There is a divide within the patient group community on this issue. Anne Kingston’s article in Maclean’s revealed that patient groups worked directly with Canadian Plasma Resources lobbyists to secure support for their operation. The reason I found this to be so problematic is that it is the responsibility to collect, manage and supply blood products belonging to Canadian Blood Services and Héma-Québec, not with the patient groups. Co-opting support from patient groups based on the false pretext that paid plasma in Canada would help their patients seems wrong.
Do we have an urgent and immediate worry about the safety of plasma-derived medications? No. We believe the best practices have proven successful with a long-term safety record since the implementation of Krever’s report. We believe that CBS is best-positioned to mitigate risks of emerging pathogens. However, we believe that the security of a domestic supply is a safety issue that has been overlooked by Health Canada, and are concerned they are ignoring CBS’s warning that the only way to secure supply is through the public blood operators.
Allowing private enterprise to enter our blood system will severely compromise the ability to maintain sufficient fresh blood for the needs of Canadian patients and access to plasma domestically collected by CBS for further fractionation. This is simply not a risk worth taking.
In closing, I would like to address one final point. Private fractionation plants are opening in Canada. It would be natural to seek private-public opportunities here to keep costs low and business within Canada. Krever was very specific that the blood agencies should never be bound to a Canadian fractionator. CBS and Héma-Québec must always have the ability to contract fractionate with a facility that has the latest safety measures and record. It does not mean that they cannot use a Canadian-based fractionator, but I want to make it clear that the fractionation side of the industry is not what this piece of legislation is about and should not enter into the consideration of this bill.
I urge you to look at the blood system as a whole when you consider this bill. I ask you please support its swift passing. Thank you.
Melanie Benard, National Director of Policy and Advocacy, Canadian Health Coalition: I’m Melanie Benard, National Director of Policy and Advocacy at the Canadian Health Coalition. I’ll be here to help answer some questions. Dr. Brill-Edwards will be giving most of our testimony today.
Dr. Michèle Brill-Edwards, Board Member, Canadian Health Coalition: Thank you, senators, for the opportunity to discuss this very crucial and complex issue.
I am a long-standing board member of the Canadian Health Coalition. The coalition has been working for 40 years, since it was founded by Tommy Douglas, to protect and improve the public health care of Canadians. We are a national organization made up of health care workers, unions, seniors, academics, community organizations, and faith-based organizations, as well as affiliated coalitions in the provinces and one territory.
The CHC has a long-standing commitment to the safety of the blood system in Canada and supported the blood injured during the Krever inquiry with their expertise in offering assistance with communication strategies for the media and the public, public demonstrations and so forth. We are not new to the issue.
I myself am a physician in pediatric emergency medicine. Previously in my career, I was a regulator with substantial expertise in the application of Canada’s Food and Drugs Act to risk manage the safety and efficacy of medicines used across Canada by Canadian physicians.
Earlier in my career, I spent 15 years at Health Canada, including four years, from 1988 to 1992, as senior physician responsible for new prescription drug approvals and clinical trials. This was during the AIDS crisis period. I also acted as a special adviser to the World Health Organization regarding the management of AIDS and AIDS drugs.
Throughout the Krever Inquiry, I served as a pro bono adviser to blood-injured Canadians and their lawyers, helping to explain the complex medical and regulatory failures at the heart of the disaster.
The groups assisted included the Canadian Hemophilia Society, the Hepatitis C Society, the HIV transfused group, and numerous individuals, including Janet Connors.
Together, we pressed years ago for the same goal that we are now trying to address — a safe, sufficient, secure blood and plasma system for Canadians.
The CHC solidly supports this legislation, Bill S-252, to ban payment for the collection of blood and plasma in Canada for several reasons: to preserve our system for collection of whole blood by necessity, an unpaid system vulnerable to competition from a paid plasma collection system; to provide a safer mechanism to increase collection of plasma without compromising our unpaid collection of whole blood; to preserve Canadian plasma for Canadians, rather than for commercial world markets; to provide control of crisis management of Canadian plasma in times of global shortage of plasma products; to reduce the risk of Canada’s heavy dependence on the U.S. as the single global source of approximately 70 per cent of plasma products worldwide; to build in, to design into our system the proven safety advantage of unpaid plasma donations; to safeguard our system against emerging pathogens which threaten the safety and sufficiency of both whole blood and plasma collection systems.
These matters pose a significant risk of contamination at a time when untestable, indestructible new pathogens arise, for example, new prion disease such as chronic wasting disease.
We need to avoid overall payment for plasma, which threatens the safety, sufficiency and security of both the whole blood and plasma systems for Canadians.
We further endorse the plans now being implemented to not just increase, but to responsibly increase collection of plasma by unpaid means to meet Canadian needs from the current 17 per cent collected by the CBS to the planned 50 per cent or preferably more.
We endorse the precautionary principle as the foundation of responsible, modern risk management of health hazards, including the management of blood and plasma both. Waiting for proof of harm, as advocated by Health Canada and the paid plasma industry, is wrong, irresponsible and contravenes the well-established risk management principles for managing health hazards universally in health care.
We reject the irresponsible scare tactics alleging this ban requires Canada to stop the importation of paid plasma products from the U.S.
That is a scurrilous misstatement to frighten patients, and you’ve heard it many times already, “thousands will die” if this bill is passed. That is completely untrue.
We reject the false assertion that plasma from unpaid donors has no safety advantage over paid plasma. In the risk management of future emerging pathogens, the clear safety advantage of unpaid plasma having a proven lower rate of infectious pathogens is a major safety advantage, not every day but especially when testing for and inactivating a new serious pathogen is not available.
Finally, I hope we all can agree with the following: We need to protect Canada’s blood and plasma systems as valued lifesaving national resources and that there is a necessity to increase Canada’s collection of plasma. That is clear. We must do it in a manner that does not compromise the collection of whole blood, which is an equally important part of our system.
We hope this bill is passed to codify the risk reduction strategy of unpaid collection of blood and plasma as a safety advantage to manage the inevitable threat of emerging pathogens, not amenable to current testing and plasma inactivation. We hope that we can all agree that the advice of international world authorities, like the World Health Organization, advocating that all nations should pursue as a goal of self-sufficiency of blood and plasma via unpaid means.
For these reasons, we urge you around the table to take this responsibility seriously and to vote in favour of a bill that protects both parts of our blood and plasma system. In the meantime, before a decision is reached, we also recommend that this body strongly recommend to our health regulator, Health Canada, that there ought to be a moratorium on new licences for further centres for the collection of paid plasma until this complex and important public health issue can be addressed. Thank you.
The Chair: Thank you very much all for your statements. We will follow with questions.
Senator Ravalia: Thank you for your very compelling testimony this morning. As you probably realize, this has been a very emotive discussion as we’ve heard viewpoints like yours and viewpoints that are opposite to yours.
We’ve heard that we procure 80 per cent of our plasma-derived products from the U.S. through a paid model and in the last 20 years there have been no concerns about any infectious issues, that there is a built-in safety approved by Health Canada that affords us an opportunity to procure a variety of plasma-derived products that are critical to the safety of a significant number of Canadians.
I’m talking from the perspective of a physician who in the 1980s dealt with the cryoprecipitate crisis and personally managed patients who had become infected with HIV and hepatitis C and all the horrendous sequelae thereof.
I’m struggling with how we, as a nation, find practical ways of attaining self-sufficiency or even 50 per cent self-sufficiency when at the present time we are at 17 per cent? Would you be able to respond to me, in a practical timeline-based manner, as to how we can attain the self-sufficiency in a completely altruistic nonpayment model?
Dr. Brill-Edwards: I would like to go back to the notion that both systems are completely safe. There is an important risk management principle at stake here. Systems can be running in a safe manner on a day-to-day basis. That is not adequate for the management of health hazards. Any health system — the blood system, the hospital system — has to prioritize planning and preparation for the unknown pathogen.
As a physician who lived through the AIDS era like you, I think we understand that disaster occurs when we ignore the emergence of new pathogens. That is the AIDS story: the slowness to react, the absence of any planning in advance of what befell us. Everyday safety is not good enough. There has to be built into the system a plan to manage the emerging pathogen. That’s why, for me, it’s a given that paid plasma from the U.S. and unpaid plasma from Canada, after they’ve been fully fractionated and after we have tested to exclude HIV and hep C and we have inactivated with heat treatment, with solvent detergent, with nano-filtration, after that process is fulfilled then the paid plasma is going to be as safe as the unpaid plasma on an everyday basis. That is what has given us our 20-year safety track record.
In fact Krever — I brought a copy of the Krever report — talked about all these everyday mechanisms that are used to inactivate the viruses that do make it into plasma. He discusses each of those mechanisms that I’ve just mentioned. In 1997 he quoted the literature to say these mechanisms are almost certainly going to work, and they did.
Why then did he advocate: do not move to a paid system? The reason — and it’s very explicit here — is that any responsible health care system, blood system included, has to prepare for the day when you face the unknown. When that unknown arises, when a new infectious agent arises, we have no way to test the blood to remove it at donation point. We have no way to inactivate it.
The third stage of plasma safety is inactivation, which is not available to whole blood. I should make that clear. At the time when the new pathogen arises, we have nothing other than the integrity of the donor to tell us if they have risk factors. That’s it, there is nothing more.
Our system in Canada still has the opportunity to retain an unpaid system, granted. It provides at present only 17 per cent of our plasma. At a time of crisis that may be enough to sustain us for the patients who really need it, like the primary immunodeficiency patients.
Properly, we should be aiming for that 50 per cent in order to really cover the critical patients who are going to die in times of crisis without immune globulin. How long it takes to get there is unpredictable. It should be our goal. If we don’t pass this bill, we have no hope of reaching that goal.
In the meantime, if it takes two years, five years, ten years, we are praying that there isn’t a new pathogen that will make inoperable the systems that we rely on today from the U.S. That’s what is going on here. There is nobody anywhere saying if you pass this bill we can’t import from the U.S. That is absolutely untrue. You’ve heard from the patient groups already. You’ve heard that frightens them terribly. It’s a good strategy if you’re in the industry and you want to expand your collection.
[Translation]
Ms. Tinga: I’d like to follow up on that response, if I may. Some of the things I heard surprised me. When, in response to the senator’s question, Dr. Brill-Edwards, says that the time frame for achieving the self-sufficiency target was unknown, we, as an association of patients, find that worrisome. There are Canadians whose very survival depends on these products, and they can’t wait 20 years. The committee heard from David Page, who was very clear on the subject.
I would add that this isn’t about banning products imported from the U.S. We have a question. Why not implement the same system in Canada and become self-sufficient ourselves? I believe Whitney Goulstone, from the Canadian Immunodeficiencies Patient Organization, made that point when she appeared before the committee. She told the committee about patients who said they would have no problem receiving paid plasma from Canadians rather than people in the U.S.
We are patient associations. We work on the ground with Héma-Québec and Canadian Blood Services, so we know achieving that self-sufficiency target is going to take a long time, and we aren’t too optimistic it will happen. We are here today to ask the committee to take that into account and to remember that the lives of Canadians hang in the balance. To increase collection and achieve self-sufficiency in Canada, we need to adopt a paid model.
[English]
Mr. Brandell: In my opening statement, I brought attention to the fact that in British Columbia we are not self-sufficient on fresh blood and plasma. That’s important because fresh blood and plasma can’t go through all these viral inactivation, heat treating and solvent detergent that plasma can go through.
We’re especially concerned about this. When Canadian Plasma Resources opened up in Saskatoon, some of the people who were just referred to said that both the public system and the private system could co-exist without any problems. By December of that year, a CBC report said that Canadian Blood Services had noticed a rapid decline in fresh blood donations. They were asking for Health Canada to put a moratorium on allowing new licences to Canadian Plasma Resources.
Considering that British Columbia relies on our neighbours to top us up for that extra 10 or 15 per cent, at what point does the private system start scavenging from the public that we start having fresh blood shortages? When you have a fresh blood shortage, it’s much worse than having a plasma shortage. If you have a plasma shortage, there are lots of markets you can go and purchase the life-saving medications around the world. When you have a fresh blood shortage, you have limited options, if none at all.
The Chair: Thank you.
Doctor?
Dr. Brill-Edwards: It’s important to understand that the treatment of sickle-cell disease is primarily dependent on the whole-blood system, what you would understand as the transfusion system for fresh blood products. It should not be placed at risk, especially for the sickle-cell community. That system should not be placed at risk in order that foreign companies can come and set up commercial operations in Canada.
The Chair: Ms. Tinga, did you want to add something? Please be brief. I want to go around with questions from the senators.
[Translation]
Ms. Tinga: Very quickly, I’d like to add to Dr. Brill-Edwards’ comments. Sickle cell anemia patients rely on fresh blood donations. Paid plasma collection does not threaten the Canadian public. On the contrary, we see no problem with it. The decline in collection by Héma-Québec and Canadian Blood Services has nothing to do with paid plasma donations. It has to do with other factors like eligibility criteria. In our case, for instance, the communities affected by blood collection are all ruled out because of malaria or other viruses. That’s the sort of thing that is a barrier to collection. Here’s another example: When a man has sexual relations with another man. These people aren’t eligible to give blood. None of that has anything to do with the paid model and does nothing to help us.
[English]
Senator M. Deacon: Thank you all for being here. We all have learned so much about plasma over the last two weeks — more than I thought I ever would or could. One of the main things I have taken away that connects to this bill is that, compared to blood, plasma is significantly more difficult to collect. There’s more involved in collecting the plasma, such as screening, the length of time someone is in donating and maintaining relationships with donors for repeat visits — coming back fairly frequently. We can’t just put a truck in front of a building, which is something we can do quite often with a blood donation setup, sometimes even on a lunch break or during a one-day with a company.
When I hear testimony like this morning, I have to wonder if it should only be the Canadian Blood Services who are collecting our plasma. With that in mind, I still think the compensation factor would probably have to happen. The reality on trying to reach these targets are a bit blue sky and altruistic in the timing and the kind of numbers we’re talking about and that we hear repeatedly.
Yesterday, yes, we had a chance to meet with for-profit industries, no question. I got a sense that an emerging private industry in Canada could meet our needs, if allowed to do so. We utilize private industry for pharmaceutical development. I hear the word “safety.” I continue to wonder why we should not allow this domestic industry supply to help supply our shortfalls instead of importing plasma from abroad.
It is still perplexing for me. If you could help me with that, I would appreciate it.
Mr. Brandell: That was a lengthy question. I apologize. There were two questions you had there. Should we allow Canadian Blood Services to pay people for their plasma? That was the first question. The second question was “why should we not allow this company to come into Canada and help fulfill the shortfall we have?”
I’ll start with the second question first. Canadian Plasma Resources’ parent or partner company, if you want to call it that, is Biotest AG. They are located in Germany. Therefore, 100 per cent of the plasma they collect goes to Germany to get processed for further fractionation into life-saving medications. The problem is that Canadian Blood Services has no contract with Biotest. To date, 100 per cent of all of that plasma that has been collected from Canadians — and a lot of people have said it’s going to help our Canadian population; in fact, it’s scavenging. It’s reducing our ability to collect plasma for our domestic needs.
To get back to your first question, I believe most of the legislation — because I was involved with the legislation passed in British Columbia — there is an exemption that if Canadian Blood Services goes ahead and tries to meet the 50 per cent plasma self-sufficiency, and we find ourselves in a position where they can’t meet that or there is an exceptional circumstance such as Krever, there is an option that they may pay people for their plasma, although that would be one of their last resorts.
Dr. Brill-Edwards: I’ll follow the pattern and answer your second question first: Why not have paid companies if it’s not a safety issue? It is a safety issue. It’s a safety issue in two ways. It’s a safety issue at times of risk. As I said, we have to prepare for the time when there is contamination, not just in our system but in other systems.
Worldwide, authorities are worried about what happens if there is any compromise to the U.S. paid system that supplies basically the world. Seventy, 75, 80; you get different percentages but it’s on the rough order of three quarters.
You have to have a system that is under Canadian control during that time of crisis. If what you have is a collection of commercial companies that are just collecting plasma with the total freedom to sell it to whichever country they choose, then you are leaving Canadian health authorities with no means to manage that crisis.
If, on the other hand, you design the system to have unpaid plasma being collected, especially at rates high enough to meet Canadian crisis needs — not treating everybody but treating those who will die if they don’t get for example immunoglobulin — then you are building a system that is resilient at times of crisis.
As I said before, is safety an issue on a day-to-day basis? No. But at a time of crisis when you cannot properly test or inactivate the new infectious agent, that’s when you really need control of your own Canadian plasma and the safety advantage of having that be an unpaid source.
It was said earlier that paid and unpaid are equivalent, and particularly for somebody who relies on whole blood. That is simply not true. There is lots of evidence in the literature of studies done that show that the starting point, the donor blood from unpaid donors, has a lower rate of infection in the blood than the blood or plasma from paid sellers.
That’s not just me saying that. You have been misled repeatedly that there is no difference. At a time of crisis, that difference is crucial. That’s why we want to maintain a Canadian system that collects unpaid plasma. There was a notion said earlier, and I have to correct it. It was a statement that it would be all right, “to pay for fresh blood.”
That is completely false. That is not true. There is no authority in the world that would say that that is acceptable. All developed countries reject the notion of paying for whole blood. That needs to be made very clear. That’s why if you have an unpaid system, you are not going to have payment competing with that whole blood system that must remain unpaid.
The Chair: Thank you.
[Translation]
Ms. Tinga: I’d just like to add one detail about the sale of Canadian plasma abroad. I believe that, initially, Canadian Plasma Resources, or CPR, offered its plasma to Canadian Blood Services at a price that was about 20 per cent cheaper than plasma from the U.S. Canadian Blood Services, however, chose not to buy it. It was then that Canadian Plasma Resources sought a licence to sell its products abroad. I think using that plasma would help us achieve the self-sufficiency target we’ve set for ourselves. The problem would go away.
Senator Mégie: My first question is for Mr. Brandell. You represent the British Columbia Chapter of the Canadian Hemophilia Society. You support the bill and an end to paid donations. However, I read that, in February 2016, the B.C. Chapter was at odds with the national agency over what you were proposing. Have you come to an agreement, or do you still have two different opinions?
[English]
Mr. Brandell: We still have two different opinions. However, as I said, we have lost funding from our national agency because we continue to have this position. Our chapter was very unfortunate, but somewhat lucky for us from a financial standpoint, that a couple of our patients succumbed to infection with HIV and hepatitis C and they left their entire estates to our chapter.
While I don’t want to jump to any conclusion as to why certain organizations have come to the conclusions that they have, our chapter has the financial independence to look at this and speak what we feel to be the truth.
Even though we have this position, we count on pharmaceutical companies to send our kids to camp and a lot of other projects. When you have a look at our yearly budget of roughly $80,000 compared to the national CHS with paid staff of over $2 million, there may be some other issues at play here as to what is motivating them.
There hasn’t been anything internally that has been sent to me from the CHS that has compelled me to understand why they continue to have this position. I have asked repeatedly. I have sent e-mails and the response keeps changing. One is that we’re going to help Canadian patients. Then, when I found that Canadian Plasma Resources has a partnership with Biotest AG and none of this plasma is going to help Canadian patients, then it became it’s good we have become a good global citizen because the more plasma out there, we are going to be able to help more patients.
I pointed out the fact that we actually are in a period of surplus plasma. There is actually more plasma out there. The cost is actually lower. By collecting more Canadian plasma, we’re not helping more patients here around the world. The plasma doesn’t magically turn into a medication. It requires funding. You need the will of the private companies and you need the support of government and non-profit organizations to come up with that money to turn it into medications that are going to help people in Third World countries.
When I dispelled that myth, the only thing they came up with is that it’s hypocritical that we accept plasma from the United States while we don’t accept plasma in Canada. As I say, the story keeps moving along as more truths are unearthed.
[Translation]
Senator Mégie: My next question is for whoever wishes to answer. The preamble to Bill S-252 states that the sustainability of the blood system in Canada must be protected. Do you think that’s warranted? Do you think the bill will ensure that the sustainability of Canada’s blood system is protected? If not, do you have other options in mind for achieving that sustainability?
[English]
Dr. Brill-Edwards: I agree with the preamble. It’s not only advisable, it’s essential there be a national priority placed on the sustainability of both the blood and the plasma supplies in Canada. I believe it is achievable to have both systems sufficiently supported by unpaid blood and plasma in Canada.
This is not a pie-in-the-sky goal. We don’t have to reach, as I said earlier, 100 per cent self-sufficiency. In fact, in risk management terms, that’s actually not the best thing. You always have to have alternative supplies around the world to manage a system safely. Sustainability means being able to keep the system running even when there is a crisis. It’s about resiliency of the system.
I will give you an example, and I will try to be brief. Recently in Ottawa, we had a double-decker bus crash into an OC Transpo shelter. The system failed in that regard unexpectedly, but there was a very skilled and capable response when all those damaged individuals, all at once, were attended to by paramedics and triaged to different hospitals in the city. The trauma centre set up eight different trauma teams, whereas we can usually manage with one.
That was all done quickly and expeditiously. Why? Because that system is managed as a health hazard system. They have been planning, preparing and practising what they would do if these various things happen. That’s why they could jump in quickly and handle things so readily.
That’s what I’m talking about here. If we have an unpaid plasma system, we are going to be able to manage the next crisis much more readily. We won’t be able to have all patients with the needed immunoglobulin, but we will be able to have the key patients covered to save their lives.
For example, with immunoglobulins, about a quarter of the supply is used for primary immunodeficiency disease, the crucial people who really need it for life preservation. About another quarter is for legitimate neurological needs. That gives us 50 per cent. But the 50 per cent beyond that worldwide is considered to be probably not properly used. Any physician who has looked into it will concede that. It’s documented well in the literature.
What I’m trying to get across is a sufficiency of supply does not mean having 100 per cent Canadian self-sufficiency from our products. It means being able to respond to an emergency in an adequate way that saves lives.
[Translation]
The Chair: Ms. Tinga, I can’t see you very well on the screen, but please raise your hand high if you’d like to speak.
Ms. Tinga: When we talk about self-sufficiency in a period of crisis for Canadians, I would point out that someone with a chronic genetic disease, be it a blood disorder or otherwise, is always in crisis mode. That may explain the sense of urgency we feel or our behaviour. We don’t have time to wait for a crisis to occur in order to make sure Canada is self-sufficient. That’s why we think it shouldn’t be an issue to adopt a system that would give us that peace of mind.
The Chair: Thank you for your comment. The views we’re hearing are indeed very polarized. Thank you very much.
[English]
Senator Francis: This is a question Senator Omidvar wanted to ask. She had to leave.
Dr. Brill-Edwards, I notice in your paper you say:
If people want or need money in exchange for their plasma, they are more likely to provide their plasma, even though they have risk factors. This has been proven by research. Blood and plasma from paid providers have a higher rate of infectious pathogens than blood and plasma from non-remunerated donors.
I am wondering: This bill does ban the sale of blood, right? Would you like to see it changed to reflect what you’re saying here?
Dr. Brill-Edwards: I think they are consistent.
Senator Francis: Okay.
Dr. Brill-Edwards: Maybe you should rephrase your question. I don’t know that I caught the gist of it.
Senator Francis: As I say, I’m asking for Senator Omidvar. She had said this bill does ban the sale of blood, but here you’re talking about paid plasma. What are your thoughts on that?
The Chair: If I may try to help a little bit. I think Senator Omidvar was referring to, in the bill, the exception for CBS to pay.
Senator Francis: Yes, exactly.
The Chair: That’s my understanding of her concern.
Dr. Brill-Edwards: Right. I think the intention is to allow for any circumstances, like rare phenotypes that we see being produced in Winnipeg. Winnipeg is much more than the original rare phenotype product now. The intention was to ensure if there is an unusual circumstance, that we have not precluded that. But, overall, because Canadian Blood Services is a voluntary donation service of both blood and plasma, that exception would be rarely required.
Senator Francis: Thank you.
[Translation]
Ms. Tinga: I find that comment a bit ironic. When it comes to rare phenotypes, it’s okay to compensate donors, but it’s not okay to compensate someone who regularly donates their plasma, saves lives and helps us progress towards self-sufficiency. It’s acceptable, though, in the case of someone whose plasma is needed less often. Isn’t that unfair?
[English]
Senator Oh: Thank you, witnesses. I am getting a lot of mixed opinion, mixed signals, coming from both sides. You say we should not go for a paid donor system, but the blood we are getting from the U.S. is all from paid donors.
What kind of safety assurance do we receive from the U.S. that guarantees it won’t be tainted, like the blood crisis we had before? What kind of safety assurance do we have from America that guarantees the blood coming to us is okay? Maybe tomorrow there will be a bombshell saying the blood we receive is tainted.
Dr. Brill-Edwards: I’ll answer it. Again, I’m struggling to get the question.
Senator Oh: I’m trying to say the plasma coming from the U.S., which we are receiving now, what kind of safety does the U.S. guarantee that their blood coming here — same thing they are getting from paid donors, right?
Dr. Brill-Edwards: What assurance do we have that the product imported from the States, based on paid plasma, is safe? There is never a guarantee. However, the fundamental reliance we have is that placed on the Food and Drug Administration in the U.S., which compels all U.S. plasma fractionators to use three rough phases of purification of a product.
The first is that it should be drawn from donors, who have been asked a variety of questions about their risk factors for infectious disease. That’s step one.
The second is the blood or plasma that’s being received is tested in the lab for various viruses, like HIV and hep C.
The third is the important step for plasma that does not occur for whole blood. That is the intensive treatment by various different inactivation systems to make sure that any virus that does get into a plasma pool, that’s going to be fractionated, is destroyed. On a day-to-day basis we can be comfortable, the track record predicted by Krever, based on all these old mechanisms — yes, they have been improved — but basically we have a safe system on a day-to-day basis.
Where we are all in trouble is if there is a new pathogen that we can’t test for, there goes stage two; we can’t destroy, there goes stage three. We only have the first stage, which is asking patients about their risk factors.
If the new prion, CWD, chronic wasting disease, turns out to be important, our only safeguard in that circumstance will be asking patients to be forthcoming about their risk factors. If they need the money for their plasma, they may well not declare those risk factors. That means, without stage two and three, that one remaining stage, that first stage, is gone.
Just to simplify: On a day-to-day basis, we can rely on the system. It’s as good as it gets in the developed world for products derived from both paid and unpaid plasma. In the face of crisis, that’s when we run into trouble.
Senator Oh: Are you telling me that the U.S. system is not safe either?
Dr. Brill-Edwards: No system is perfectly safe, and no system is safe in the face of an unknown pathogen. The best we can do at that time of crisis is to reduce the risk.
We can’t eliminate the risk with an unknown. We don’t even know what we’re dealing with when they show up. We can’t test, right? We can’t inactivate. The only measures we can take are risk-reduction measures, not risk elimination measures.
The Chair: Thank you. Mr. Brandell?
Mr. Brandell: I just wanted to let the senators know that in 1995, I received contaminated blood from a gentleman who later died of Creutzfeldt-Jakob disease, which is a prion disease. Now, interestingly enough, that particular batch of plasma that infected me did come from the United States. It came from a Utah donor. It came from reclaimed plasma, which means it came from unpaid blood from the United States. It came to Canada, and then Canadian Blood Services at that point turned it into life-saving medication for me, which I have since taken. With this prion disease the incubation period can be 15, 20 years up to 40 years. I have unexplained neurological conditions that my neurologist hasn’t been able to attribute to anything else.
The reason I bring this up is that I have followed this very closely, and I’ve been in touch with the CJD Surveillance Unit in Edinburgh, Scotland. I have talked to some of the top neurologists about the possibility of me going down the road and dying of this brain-wasting disease. Of course, when you look at that, you have to look at the fact that when CJD broke out in the U.K., it shut down their blood system overnight. In that situation, they really had to rely on other countries to help them out because they had this new emergent pathogen that they didn’t know how to deal with.
I think that when we’re talking — and Dr. Michèle Brill-Edwards is talking about trying to get to close to 50 per cent self-sufficiency but not trying to get to 100 per cent self-sufficiency, I think that’s an important thing because if there is an outbreak of some sort of prion or some sort of emergent pathogen we can’t control, from the United States, that we have enough supply here in Canada to contain ourselves. If we have an outbreak in Canada, we have the ability to go to the United States or to other jurisdictions to cover that shortfall.
Once again, I get back to the fact that Canadian Plasma Resources currently only sells to Biotest, and none of that stuff comes back to Canada. People keep talking about how Canadian Plasma Resources is going to help us on self-sufficiency. If 100 per cent of the plasma they collect is leaving the country, never to come back, I do not see how this is going to help our self-sufficiency in plasma. And when we do have this sort of crisis, we now have a company that can sell to the highest bidder. If we have Canadian Blood Services controlling that — I hate to call it a commodity — they can make sure that it’s here to help the Canadians who are most sick.
[Translation]
Ms. Tinga: I would say there is no doubt that the risk is ever-present everywhere. From my experience, I’ve learned that, in Canada, we have sound controls in place. Sickle cell anemia patients can have confidence in the products they receive from Canadian Blood Services, Héma-Québec or Quebec’s Plasmavie clinics. I can have confidence in the Biologics and Genetic Therapies Directorate and the industry fractionation associations, who could explain to the committee the processes in place to ensure Canadians are protected. I’m not going to rely on unfounded assertions to conclude that payment to donors would have a negative impact. As the witness mentioned, even products from the U.S. aren’t safe. I would prefer to take a chance on a product that came from here rather than a foreign product that isn’t worth the risk. I don’t see the logic in that argument. It doesn’t make sense to me.
[English]
Senator Eaton: Dr. Brill-Edwards, you said several times today that on a day-to-day basis, we’re safe. It’s the new unknown pathogen that we can’t test for. We have heard testimony saying that, for instance, EU countries, as well as the U.S., all pay their plasma donors. Why are we special? In other words, they don’t seem to be worried about a crisis and unknown pathogens. I guess they don’t think it’s practicable. We’re stepping out into unknown territory here?
Dr. Brill-Edwards: No. What you have been led to believe about Europe is actually not true. I would encourage you to invite European authorities to come and to testify because there are many success stories in Europe. It is not appreciated, I’m sure, by the committee that there is a growing unease in Europe —
Senator Eaton: Do you have specific countries we should invite?
Dr. Brill-Edwards: I would suggest the association of public blood and plasma collectors in Europe, the European Blood Alliance. They have a number of documents that are very informative.
Senator Eaton: Are there countries like Germany or Britain or France who are worried about what you’re worried about?
Dr. Brill-Edwards: You mentioned Britain. Twenty-one years ago, in 1998, the U.K. lost their entire plasma collection because of just the kind of threat we’re talking about, a new emerging pathogen in the blood system that transmitted from mad cow disease in cattle to humans and then into the blood. Today, the U.K.’s plasma collection is non-existent. They lost their plasma system because they could not reverse the contamination. What I’m trying to get at is what we need is —
Senator Eaton: They buy it from other countries who do pay their donors?
Dr. Brill-Edwards: Absolutely. They not only buy it from other countries that do pay their donors, they actually bought a U.S. paid-plasma collector. That’s what I’m getting at here. Once you go down that road, you’re stuck. When you go down that road of paid plasma and say, “Oh, what the hell, let’s just buy from the other large systems in the world — one large system in the world, the U.S.” Once you go down that road, you can’t go back.
The European Blood Alliance has a publication dated in I believe it’s 2014, in which they very clearly discuss the risk posed by paid plasma in eroding the unpaid whole blood collection. What you’re dealing with is a scenario where once you have paid plasma going on in a country, your whole blood system is diminished. Then, even if that paid plasma ends, only one in six donors will return to the unpaid system. We have a chance right now to not go down that road.
Senator Eaton: What I’m trying to get at and perhaps we’ll have to do some research, you talk about an association but have countries like France and Germany and Switzerland and Italy adopted their recommendations or are they still going the paid donor route?
Dr. Brill-Edwards: No. We can provide you the story of Italy. It’s fairly lengthy but basically they have returned to an unpaid system, yes.
Senator Eaton: For plasma and blood?
Dr. Brill-Edwards: Yes. I think from what we have witnessed to date, the committee has basically been told that everywhere else in the world paid is fine; nobody is worried. Simply not true. I encourage you to listen to other blood authorities. You mentioned France. My understanding is the head of the French blood collection agency is very vocal and quite willing to give testimony indicating that lack of payment is a very important issue for France.
It is hard, if you are listening to different witnesses coming at you from difference perspectives, to sort the wheat from the chaff.
Senator Eaton: You are right, especially when you are not an expert in the field, and there have been questions about paid and unpaid donations.
Dr. Brill-Edwards: Yes.
Senator Eaton: Is it a matter of demographics? Because we were told that every testimony is subjective, that there is no difference. You’ve said today, in your testimony, there is literature saying that unpaid donations are cleaner. There are less infectious diseases. Is that up to date?
Dr. Brill-Edwards: Yes.
Senator Eaton: Has it changed?
Dr. Brill-Edwards: No, it has not. The World Health Organization has made its recommendation for all member states to have a goal of self-sufficiency and unpaid blood and plasma for a couple of decades, but they have repeatedly reassessed that position.
It is important to understand the strategy of arguments. In order to argue that Canada should have a paid system, there is no safety advantage. By saying there is no safety advantage, you’ve made the choice — well, then, let’s go ahead.
There is a very intensive effort to, for example, deny Krever, to say he was out of date. Not so. All these systems were in place when he made his recommendation for unpaid blood and plasma collection.
The next argument is: Well, nobody else in the world is worried about paid plasma. Excuse me. The European Union is concerned about it. There are growing concerns, in multiple countries, about the health risk of not having access to that huge supply of plasma products, even though paid.
If anything happens to the U.S. — and, remember, CWD is endemic in the western part of the U.S. If that prion jumps to humans, that whole U.S. plasma supply is at risk. That will create a worldwide crisis. Nobody is openly speaking about it because it is very frightening. For example, it is important for this committee to consider what would happen if we lose the U.S. system globally.
Senator Eaton: We couldn’t manufacture our own plasma, anyway, could we, right now?
Dr. Brill-Edwards: What you could do, if you have control over your own supply, if you have a national agency paid publicly to collect plasma, the contracts can be made with fractionators who agree to fractionate your products separate from other products.
Another recommendation of Krever — do not allow plasma pools to contain a mixture of Canadian plasma and foreign plasma of unknown source. It is a danger to the system; a hazard.
If you have national control, you are able to use that asset in a wise way to prioritize the use of that asset and make sure that provinces and the whole country are not dependent on commercial operators who don’t have to sell to us.
Senator Eaton: We could do that and still have paid donations.
Dr. Brill-Edwards: Perhaps I’m not being clear.
Senator Eaton: No, you are being very clear. We could have paid donations and Canadian blood could be kept separately when it goes to Germany to be fractionated and could come back to Canada?
Dr. Brill-Edwards: That’s not even imaginable. Once you have a collection of operators in the same national geographic area, you have a multiplicity of companies who, as Dr. Bahardoust said yesterday, they are commercial entities. They have no intention — no need, no mandate — to be a health service. When they entered the system, the amount of plasma collected by the CBS, it will not go up — it will go down — because the competition will be fierce.
Yesterday you heard about the size of the global industry quadrupling over the last roughly 10, 15 years. There will be a severe competition for donors. The whole idea of CBS being able to increase its plasma collection is really not feasible.
[Translation]
Ms. Tinga: I’d like to follow up on what was just said. In a YouTube video posted by Canadian Blood Services on July 25, 2018, Dr. Graham Sher says this:
It is categorically untrue to say, in 2015 or 2016, that plasma protein products from paid donors are less safe or unsafe. They are not. They are as safe as the products manufactured from our unremunerated or unpaid donors.
That’s pretty clear to us. I think there is a desire to mislead people into thinking that donors who are paid could be less honest. I think that’s utterly offensive to the population of Canadians who have been donating voluntarily for years. We contribute to many blood drives, and we — especially the Black community, which suffers from sickle cell anemia — go through a highly rigorous selection process. A lot of people are deemed ineligible because of the current criteria.
I understand that a person wouldn’t volunteer to give blood when they’ve lived in a place where there was a risk of contracting malaria. I think this casts doubt on the honesty of donors. What’s more, the compensation is so minimal that I can’t see anyone running the risk of being rejected, especially given that individuals who have been assessed and deemed ineligible to donate appear in a nation-wide database. The screening system can’t be bypassed.
I therefore don’t see the problem. Taking an alarmist attitude to safety merely causes confusion and creates fear in people’s minds. The two things have to be dealt with separately: we are talking about plasma donation, not about blood donation. Whole blood donation will always be volunteer-based in Canada.
The Chair: Thank you, Ms. Tinga. It’s clear that the witnesses have opposing views and that each holds firmly to their convictions. It will be quite the job for senators to sort through all the numbers and information. I can assure you that we will do so guided by our responsibilities, and we appreciate all the perspectives you have shared with us today.
[English]
Senator Moodie: Thank you for being here today and helping us understand more about this puzzling and very complicated situation concerning plasma.
I’ve been trying to understand, since yesterday, the crux of the problem. Yesterday I thought it was ethics. I am now beyond that. Today it is my sense that what we are focusing on is control of a system of access to plasma supply.
In the public health world, it is important to manage infection control, emerging pathogens, to be able to divert, stop, and remove product that could potentially harm our population from circulation, and do it quickly and with absolute control. I get that.
What I’m trying to understand is, why does it matter where that product is coming from? And can we make an argument that, in some way, a commercial source of plasma is less controllable than plasma that’s originating within a system of control by, say, the Canadian Blood Services? Are there contracts, requirements, agreements or quality control regulatory requirements that could force or maintain a certain level of control for the infection control people who will be dealing with breakthrough issues, that would allow us to be able to use product here in Canada, whether paid or not?
I’m dealing with control. Control of the system, effective control of the crisis. Because I hear that as a problem. Is there any reason why the commercial entity has a different level of control?
[Translation]
The Chair: Ms. Tinga, since you’re joining us by video conference, you occasionally get overlooked. Would you like to answer first?
Ms. Tinga: I want to start by saying that we’ve never called into question the quality of the product or suggested that the source of the product — commercial versus public — was problematic. The fact that Canadian Blood Services buys plasma from the U.S. means the agency is able to ensure the safety of Canadians. We see no reason to doubt the quality of the product it normally provides to Canadians.
What we do have a problem with is the fact that we, as Canadians, are unable to achieve self-sufficiency. We have the capacity. The people with the ability to do it are here, so why not adopt the same system as the Americans and meet that collection target?
If I understood your question correctly, it’s about why a commercially sourced product would be less safe than a publicly sourced one. I don’t think that’s the case, however, because the product is subject to rigorous controls in Canada regardless.
[English]
Senator Moodie: I would like to direct a question to Dr. Brill-Edwards, because it was a big focus of what you were talking about in terms of control of the crisis situation and the need to have the ability to manage where resources go and whether that’s an issue in terms of sourcing the product. How is it an issue? Why don’t we have control? Why can’t we rely on commercial providers? Is there a problem there?
Dr. Brill-Edwards: We rely on commercial providers at this point in time. As I’ve said, on an everyday basis, there is no problem. What we need when the system is in the crisis is the ability to make national decisions that meet the needs of the various parts of Canada. That’s an obligatory part of our health governance system. That’s in the national legislation establishing the role of the Minister of Health. If we have a collection of commercial operators, we have no control over their decisions to send much-needed products elsewhere. If there is, for example, a global shortage, if something does happen to the U.S. system and we can’t get enough product, if we have a collection of commercial plasma collectors, they can send that plasma anywhere they like. We have no means to stop that. If, by contrast, we have a single, publicly operated national system, then we have the control systems. For example, for the Department of Health to work with the Canadian Blood Services to ensure that particular areas of health need are met.
Once we have a collection of commercial operators, as Dr. Bahardoust said yesterday: We are commercial entities; we have no mandate to provide health services. That’s what I’m trying to get at. That we keep the system amenable to any kind of unforeseen crisis.
Senator Moodie: What I hear you saying is, not only do you retain control to manage the crisis, because you maintain the resources, I’m also hearing you say that good risk management does not really require the complete 100 per cent production by one source.
Dr. Brill-Edwards: Correct, yes.
Senator Moodie: You need to diversify. I heard you say that.
Dr. Brill-Edwards: Yes.
Senator Moodie: Again, what we are puzzling with is, why not a Canadian source? I think that’s the essence in the room. Why an American source? Why not a Canadian source? Why are we with willing to pay in the U.S. and not do that here? If what we are saying is we want a robust public system, we want to be able to manage it, absolutely, help us do that by controlling the market. But what I also hear is that we need to have the ability and flexibility at the margins to find product if we need it, if our system gets polluted, for example. I am hearing that. I’m wondering about the source now in terms of the American choice versus the Canadian choice. We’ve been dealing with that the last few days here. Why not Canadian?
Mr. Brandell: I think what we are overlooking is that we are taking it from a public system to a private system. I think taking it from public to private is very polite. What we should be saying is something like, we are commercializing the plasma. Turning it into a commodity.
I think anyone who followed what happened to the GM workers recently in Canada that the Canadian government bailed them out — I don’t want to get off the topic here — but the Canadian government bailed out that industry with $7 billion with the anticipation that those jobs would remain in Canada. The government has a very poor track record of regulating business and keeping business within Canada, because business can do whatever it wants after we lose control of the situation. That’s why we need to keep it in the public system. As soon as it goes outside the public system you can have all kinds of regulations but the companies have very deep pockets and they will find ways to go around it and to outsource it. What we’re trying to do is ensure that we control the resource as best as possible for Canadian patients. The only way to do that is to maintain a fully public system within Canada.
The Chair: Thank you. I want to follow up with a simple yes or no question, because it is a puzzle. I hear what everybody is saying. Can it be — you know, multiple? Isn’t a scenario possible where we have CBS reaching its 50 per cent target, we continue to have a relationship with U.S. providers and, because that’s possible, CPR contracts and provides to CBS. Would you say yes or no to something like that? Would you say no?
Mr. Brandell: Absolutely. The provision we had in British Columbia is if we came to that situation, Canadian Blood Services could seek out a private fractionator and they would be subcontracted to Canadian Blood Services and they would have control over that private contract. That’s a completely different situation than having a multinational corporation come to Canada to try to harvest our plasma and sell it overseas. They keep telling us it is from Canadians for Canadians and it was in a lot of their literature. None of this product has yet to come back to Canada.
One of the things I do want to bring up is that this company Canadian Plasma Resources, they have questionable practices. For example, when they were trying to open up in Ontario, before they got shut down there, they were trying to open up very close to a methadone clinic and a homeless shelter. They were trying to take advantage of the poorest people in this country.
If they were truly looking to get the best quality — I don’t want to make it seem like people who are poor are less than other people, but, quite, frankly, people who are poor don’t have access to the same quality of food. Unfortunately, there is a higher incidence of drug use and things that could be problematic to the blood system.
I think if Canadian Plasma Resources were really serious about coming into Canada to create a Canadian product for Canadian consumers, they would open up their collection centres perhaps on Oak Street, in the middle of Shaughnessy, in Vancouver, where I come from, and not some place like the Downtown Eastside.
The Chair: Thank you for clarifying your position.
Senator Seidman: I have a question for you, Dr. Brill-Edwards. This is really tough. As we suggested yesterday, it is very hard to understand how we are willing to use plasma that has been paid for in other countries, but are not willing to pay Canadians for their time, at least, in donating plasma.
I heard you suggest somehow that a voluntary donation system, through the CBS, for example, is better at responding to an emergency pathogen than the paid-donor system. Why would you say that?
Dr. Brill-Edwards: Sorry, say that again, the voluntary — ?
Senator Seidman: You are suggesting today that the voluntary donation system is better at responding to an emergency pathogen than the paid-donor system. Why would you say that?
Dr. Brill-Edwards: The key safety advantage at a time of response is to have the raw product with the least likely rate of infection. That’s standard, right? If you had a choice between —
Senator Seidman: Excuse me, I don’t mean to interrupt. I’m really trying to understand this. Why then is the voluntary system better than the paid system? If you want safety and if you are worried about —
Dr. Brill-Edwards: The safety advantage.
Senator Seidman: Yeah, but why?
Dr. Brill-Edwards: The safety advantage of the unpaid system is that you start with a raw product, whether it is blood or plasma, that has a lower rate of infection than the plasma or blood collected from a paid system.
Senator Seidman: Why do you say that, though? Because everything that we heard yesterday would not suggest that at all. It would suggest that —
Dr. Brill-Edwards: I know; that’s what I am getting at. You are naturally going to be confused when you are being given information that’s contradictory. The best we can do is point to the —
Senator Seidman: You are suggesting that the Health Canada regulatory agencies, the FDA, the European Union regulatory agencies, don’t have control over the private donations and so-called commercial enterprises the same way they do over the public system. I think there is testimony over decades and certainly the history resulting in the Krever report would suggest otherwise. I don’t understand that suggestion.
Dr. Brill-Edwards: What we are getting at is not control over product. It’s quality. Health Canada has control over what testing must be done and what inactivation systems must be at play. The FDA has similar control and similar standards. That’s not the issue. The issue is there are different levels of infectious agents in the raw product. Luckily, we are at a stage now where it doesn’t really matter that much because of the ability to inactivate — whatever term you want to use — purify, clean up? I don’t want to go into the technical terms but the ability to get rid of those viruses in the system is very good.
Whether you start with a low level or high level of infection for plasma, it will get cleaned up in that third phase of inactivation. What we are talking about when we say we want to keep our system unpaid, and this is a unique opportunity, not every country still has a mostly voluntary system. The advantage of that system is not evident on a regular basis. It is seen when there is a crisis and you need to manage the system to allow for the best possible quality of product.
Senator Seidman: I still don’t understand. If a new pathogen were to suddenly enter the system, there is absolutely nothing to suggest that the new pathogen would be present in the volunteer system just as much as it would be present in the paid-donor system.
Dr. Brill-Edwards: Thank you; thank you. That’s exactly the point. Where do we get that perspective? If we know that, over time and over many, many different types of pathogens, unpaid collection has a lower incidence and paid has a higher incidence —
Senator Seidman: We don’t know that.
Dr. Brill-Edwards: We do. I am sorry; I know that you have been told repeatedly the opposite but we do know that.
Senator Seidman: Only in whole blood, though. We don’t know anything —
Dr. Brill-Edwards: Actually, it is also in plasma as well. It is interesting how you research the literature —
Senator Seidman: Would you be able to send that?
Dr. Brill-Edwards: It is in our brief and the references are there. I see where the confusion is coming from. The likelihood is the new pathogen will have a similar distribution as previous pathogens. As risk managers, that’s a reasonable assumption. Remember, at times of crisis, you don’t wait for proof of harm. You can’t test. You use your best evidence, even though it is inadequate. At that point, both systems will be at risk. You are absolutely right.
We are not saying the unpaid system will be squeaky clean and the paid system will be absolutely contaminated; not at all. I appreciate your question. What we anticipate is that the unpaid, in its raw collection, will have a lower rate of infection and, when we don’t have any way to get rid of whatever is there, then starting with a lower rate of infection, is an advantage.
Senator Seidman: I guess I don’t agree with your basic premise. I don’t agree that, if you have a new pathogen that has absolutely anything to do with starting with a lower rate of infection. It is not a lower rate of infection; it is an infection by a particular pathogen in the system. A lower rate of infection — it makes no sense to me. From a scientific point of view, it makes absolutely no sense to make that statement.
Dr. Brill-Edwards: As a risk manager for many years dealing with emergency situations with medicines across Canada, that is the standard risk management approach — to look for possible advantages to avoid harm or possible interventions to avoid harm. If we know that other pathogens are present in a higher amount on a regular basis over time and over many pathogens, it is a reasonable assumption and we would work with that. I agree with you there is uncertainty and that’s what risk management is all about, managing uncertainty to the best advantage of the public.
Going back to your question about the commercial sector, the commercial sector has no mandate whatsoever to handle a health crisis.
Senator Seidman: Are you familiar with the Health Canada report published in May 2018, entitled Protecting Access to Immune Globulins for Canadians? It was an expert advisory panel.
Dr. Brill-Edwards: I was one of the experts that contributed to the work, yes.
Senator Seidman: Perfect. In that case, in the report, it says there is no compelling data to suggest that expansion of source plasma collection, whether with paid or unpaid donors, has negatively impacted the blood supply.
Dr. Brill-Edwards: To me, that’s one of the statements that discredits the report because there is clear evidence to the contrary. We provided you with that evidence.
Let me just read from the European Blood Alliance document of October 2016, which well predates the May 2018 report that we are speaking of, by the expert panel.
In countries with dual systems (where paid and unpaid collection co-exist), blood establishments who collect components encounter increasing difficulties in recruiting and maintaining unpaid donors.
In that document, components means the fresh whole blood for transfusion.
The paid system does erode the voluntary system. There is evidence in various countries throughout the world and it was, I think, inadequate performance of the expert advisory committee to suggest that there was no evidence of that.
Senator Seidman: Then are you disputing the testimony that we heard yesterday from Canadian Plasma Resources where they said, in no uncertain terms, that even CBS’s most recent report indicates they have experienced a 35.8 per cent increase in total voluntary whole blood donors in Saskatoon since they began operations there. They said that increase in donors was more than double the increase for the rest of the province. If anything, they said, this suggests a crowding in of new volunteer blood donors for CBS.
Dr. Brill-Edwards: I heard that testimony and I find it the opposite of what we have heard from Canadian Blood Services. I urge you, when they arrive, to ask the appropriate questions, which is not to compare single years one to the other. In medicine, you look at an array of evidence. What should have been discussed was the percentages of collection, not of whole systems and not of two years, but of individual components and an array of years. Who knows what else was going on in those particular years? But, certainly, that testimony contradicts CBS.
Senator Seidman: This is CBS’s. We will ask them, of course. This is the most recent CBS report that’s been quoted.
Dr. Brill-Edwards: I am saying we need to know more. The bit that was quoted was certainly not enough to make any kind of a complete conclusion.
Senator Seidman: This was since Canadian Plasma Resources began their operations. That’s all we had to compare with.
Dr. Brill-Edwards: I’m making the point that you don’t compare one year with another. You compare the preceding number of years. I agree that you probably only have a short three years since they started, but it has to be that extent of a time frame.
Senator Seidman: Right, so we will ask them directly.
The Chair: We have no more questions. Ms. Tinga, do you want to add a little something before we conclude?
[Translation]
It’s always more challenging when the witness isn’t here in person, so I’d like to give you an opportunity to say a few words quickly. The meeting will be ending in a few minutes.
Ms. Tinga: I’d like to thank you again for listening to us so patiently and asking questions that allowed us to explain our position.
I will end by highlighting the interesting note on which today’s discussion has ended, especially with experts contradicting work they actually contributed to. That speaks to the depth and importance of our discussion today. I hope you will continue to hear from other experts with a view to making an informed decision for Canadians who rely on plasma products. Keep in mind that we are here to support your work. We all depend on blood products. I think Canada would benefit from looking at what other countries are doing and adopting a collection model that would bring about self-sufficiency and ensure the well-being of Canadians. Thank you.
The Chair: Thank you.
[English]
Thank you very much for being here. You can see that we have still a lot of digging to do and putting together pieces of the puzzle. I assure you that we take this responsibility very seriously and will continue in the following weeks. We will continue the study of Bill S-252 in our next meeting on March 20.
[Translation]
If there’s nothing else, then I will conclude today’s meeting by thanking you all for being here. Thank you.
(The committee adjourned.)