Proceedings of the Standing Senate Committee on
Social Affairs, Science and Technology
Issue No. 55 - Evidence - March 20, 2019
OTTAWA, Wednesday, March 20, 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 4:17 p.m. to study the bill.
Senator Chantal Petitclerc (chair) in the chair.
[Translation]
The Chair: Welcome to the Standing Senate Committee on Social Affairs, Science and Technology. I’m Senator Chantal Petitclerc from Quebec. It’s a pleasure and a privilege to chair this meeting today.
[English]
Before we give the floor to our witness, I would like to invite my colleagues to introduce themselves, starting with the deputy chair.
Senator Seidman: Judith Seidman, Quebec.
Senator Eaton: Nicole Eaton, Ontario.
[Translation]
Senator Poirier: Welcome. Rose-May Poirier from New Brunswick.
[English]
Senator Ravalia: Mohamed-Iqbal Ravalia, Newfoundland and Labrador.
[Translation]
Senator Forest-Niesing: Good afternoon and welcome. Josée Forest-Niesing from northern Ontario.
Senator Mégie: Marie-Françoise Mégie from Quebec.
[English]
Senator Oh: Victor Oh, Ontario.
Senator Munson: Senator Jim Munson, Ontario.
Senator M. Deacon: Senator Marty Deacon, Ontario.
Senator Kutcher: Stanley Kutcher, Nova Scotia.
Senator Dasko: Senator Donna Dasko, Ontario.
Senator Omidvar: Ratna Omidvar, Ontario.
Senator Moodie: Senator Rosemary Moodie, Ontario.
[Translation]
The Chair: Today we’re continuing our study of Bill S-252, Voluntary Blood Donations Act (An Act to amend the Blood Regulations). This is our sixth meeting as part of our study of the bill.
[English]
To begin, we have two witnesses with us.
[Translation]
We’re joined by Ms. Jennifer Chandler, Professor of Law at the University of Ottawa’s Centre for Health Law, Policy and Ethics; and Ms. Vanessa Gruben, Professor. Welcome Ms. Chandler and Ms. Gruben.
[English]
Thank you so much for being here. I would like to remind you that you do have seven minutes for your opening statements.
Your opening statements will be followed by questions from our colleagues.
Jennifer Chandler, Professor of Law, Centre for Health Law, Policy and Ethics, University of Ottawa, as an individual: Good afternoon and thank you for the opportunity to speak here today. My colleague Vanessa Gruben and I are both professors of law, and we will focus today on selected ethical and legal considerations and hope it will be useful to you.
I would like to start by addressing the question of self-sufficiency in the supply of plasma-derived products, which has important implications for Canadians.
It makes sense for legislators and regulators, charged with representing and protecting the interests of the Canadian public, to evaluate the issue of paid donation from the perspective of its impact on Canadian patients and potential donors. It’s important also to note that Canada is part of an international ecosystem with regard to plasma-derived products in which the bulk of the plasma on which we depend is sourced abroad, and most of what we do collect is processed abroad on our behalf.
This intersection can be a good thing. Economies of scale in production are possible when resources are shared. The risk of disruption in supply is reduced when more groups at the national or subnational levels are collecting plasma and contributing to the supply of raw materials.
At present, as mentioned, Canada is dependent upon others and contributes very little to the diversity of supply of plasma globally. The bulk of our supply comes from people abroad who are paid to donate and fractionators who are paid to process plasma on our behalf. We’re not alone. There are many jurisdictions taking a similar approach.
However, given this global interconnected system, our policy and ethical focus has to extend to be similarly global, or at least globally aware. At present we are the second-highest per capita consumer of plasma products after the U.S., but we differ from the U.S. in that we don’t produce enough to meet our own very high demand.
Global demand for plasma products is forecasted to increase steadily. Two responses are likely: increasingly competitive efforts to induce donation and increase in price as a result. This is likely to involve more aggressive pursuit of paid donors in jurisdictions like the United States.
Countries like Canada that are not self-sufficient will be contributing to this increased global demand, fuelling both paid donation abroad and price increases for plasma products. This translates to fewer resources available for other domestic health care needs, and it’s important to note that patients in low-resource countries, whose health systems are already strapped, will only struggle more if prices increase due to this increased demand.
Given that poorer countries may also lack the infrastructure to safely become self-sufficient with respect to their own needs, there are moral reasons for those who have an infrastructure to do what they can to achieve self-sufficiency. Self-sufficiency is not justified solely by our own interests but also by the interests of others with lesser means.
Self-sufficiency does not put us at risk of an inadequately diverse supply any more than any other self-sufficient jurisdictions would be at risk from their self-sufficiency. Instead, we would contribute capacity that would increase the diversity of supply globally to the benefit of the entire system, and we can negotiate continued access to the global supply in the event of a supply disruption at home.
Self-sufficiency requires that we decrease our demand and/or increase our supply. The recent expert panel report, chaired by Dr. Ballam, whom I understand you will be hearing from tomorrow, suggests that there’s likely room to improve our own patterns of use and decrease our needs. As for increasing supply, the available evidence tends to suggest that only those jurisdictions that compensate or permit reimbursement of donors have been able to achieve self-sufficiency.
Since we are prepared to rely primarily on paid American donors, we have a real problem in explaining why we should not consider some form of compensation for donors in Canada, particularly with high and increasing demand that will promote this tightened supply worldwide.
That being said, U.S.-style commercial collection from paid donors is not the only approach to do so. Regulated compensation through non-profit rather than commercial collectors is an option. Furthermore, as my colleague will discuss, there is some evidence that self-sufficiency can be approached through reimbursement as opposed to the provision of positive motivating inducements of money above reimbursement.
Vanessa Gruben, Professor, Centre for Health Law, Policy and Ethics, University of Ottawa, as an individual: Good afternoon. Thank you for inviting me to speak on this important bill. As Jennifer mentioned, my comments this afternoon are going to focus on the role of reimbursements in achieving self-sufficiency of plasma products in Canada.
I want to discuss the important differences between remuneration, incentives, inducements, benefits and reimbursement. Sometimes these terms are used quite loosely and interchangeably, and so I would like to spend a little time unpacking the use of those terms, particularly in Canadian law.
Then I would like to talk about the importance of exempting Canadian Blood Services, or some other non-profit organization, from the proposed prohibition in the bill to ensure that there is a non-profit organization that is equipped with the flexibility to achieve self-sufficiency.
As Professor Chandler discussed, some have argued that some form of payment or incentive is necessary to achieve self-sufficiency, and the terms “remuneration,” “payment” and “benefit” have often been used interchangeably. It’s important to have a good understanding of the scope of their terms and their application in Canadian law.
There are a number of federal and provincial laws that ban the buying and selling of various body parts, whether it be organs and tissues, blood products or sperm and eggs. What’s common among these statutes, including Bill S-252, is that they all adopt a broad prohibition on purchase and sale. For example, most provincial statutes prohibit the purchase or sale of organs for valuable consideration or prohibit the exchange of organs for any reward or benefit.
Those terms “valuable consideration” and “benefit” have been defined expansively by the courts and certainly extend, as we know, beyond simply cash exchanges, to any exchange that could create an incentive to donate.
Where we do see inconsistencies in the legal framework is with respect to reimbursement. A few laws have carved out exceptions for reimbursement, presumably to ensure that donors are not out of pocket for engaging in an altruistic act.
Take, for example, living organ donors. Although provincial laws ban the purchase and sale of organs, certain provinces do permit reimbursement of some expenses incurred by living organ donors. For example, in British Columbia and Ontario, and a few others, there are programs for reimbursing the expenses of living organ donors which allow donors to claim up to a certain amount for out-of-pocket expenses which can include things like travel, accommodation, parking and meals.
Similarly, at the federal level, the Assisted Human Reproduction Act prohibits the purchase, offer to purchase or advertising for the purchase of sperm or ova from a donor, but the act does permit sperm and egg donors to be reimbursed for certain expenses. As I’m sure many of you know, the proposed regulations that Health Canada has put forth are currently shaping what the range of those expenditures will be. The proposed regs for sperm and ova donors currently have proposed travel expenditures, including expenditures for transportation, parking and meals.
Outside of Canada, certain countries also permit reimbursement for blood and plasma donation. Take, for example, New Zealand. It has adopted a reimbursement model for blood and plasma. Under New Zealand law, payment is prohibited, but an organization may reimburse donors for “the actual and reasonable costs incurred by that person in connection with its collection.”
From the information we could gather, New Zealand appears to be close to 90 per cent self-sufficient for plasma products. But there are a number of Canadian laws that do not allow for reimbursement of expenses incurred as a result of donation, and these laws generally fall into two categories. On the one hand, we have certain laws that are silent on whether or not reimbursement is permitted, and, in the other category, are laws that explicitly prohibit reimbursement.
We do see several provincial laws that govern payment for blood and plasma donation that explicitly prohibit reimbursement by including reimbursement explicitly in the definition of “payment”. This is seen in Ontario’s Voluntary Blood Donations Act. It bans payments to any individual in return for the giving of blood, and payment is defined in the act to include reimbursement for time, travel and expenditures of any kind.
Turning to Bill S-252, it’s not entirely clear whether reimbursements would be permitted under this legislation by any organization other than Canadian Blood Services. The bill bans remuneration and benefits, so this clearly includes a payment or an exchange that would create an incentive to donate, but I think there is some question in law about whether the term “benefit” includes the reimbursement of expenses. Some have argued that where a broad approach to what constitutes a “reimbursement” is taken, it may be that a reimbursement could qualify as a benefit. But if a reimbursement is clearly defined, and it seeks to replace a quantifiable expenditure that’s clearly incurred in the course of donation, it arguably would not fall within that definition of “benefit”.
In our view, there is an important legal and ethical distinction between payments, remuneration or incentives and reimbursements. Incentives seek to encourage donation by providing some benefit to the donor and we’ve seen proposals for incentives in a range of different areas in Canada. For example, there have been proposals to pay for some or all of a deceased organ donor’s funeral expenses.
By contrast, reimbursement ensures that people who act as donors do not suffer an economic disadvantage. In other words, they are not out of pocket. Thus the donor neither loses nor makes money.
We believe that permitting the reimbursement of expenses incurred in the course of donating plasma should be permitted. It’s consistent with an altruistic approach to blood and plasma donation, with a number of federal and provincial laws which allow for the reimbursement of expenses as part of an altruistic model of donation, and with the approach adopted by other countries.
I want to turn briefly to my second point, because I know time is limited, which is with respect to the exemption of Canadian Blood Services from the prohibition on providing remuneration or benefit to other donors.
In our view, Canadian Blood Services, as a well-established, non-profit organization which has significant experience in blood and plasma collection, is well placed to administer and manage a system of reimbursement for donors. Further, Canadian Blood Services is also subject to oversight by Health Canada, which promotes public confidence in the safety and security of the system. Thank you.
The Chair: Thank you both. We will continue with questions.
Senator Seidman: Thank you both very much for your presentations.
You know this is seemingly simple, but it’s not so simple. I think when we’re making these kinds of legislative decisions, we have to take our responsibilities as parliamentarians seriously. I really appreciate your perspectives on this.
If you look at societal support and what motivates people to be altruistic, which sort of underlies this legislation — and I think it was you, Ms. Gruben, who spoke about it — there was a study by Nicola Lacetera from the University of Toronto and Mario Macis from Johns Hopkins. They conducted research on what motivates people to be altruistic. In 2018, they conducted a randomized survey experiment with a representative sample of 826 Canadian residents, and I’m sure you’re familiar with it. In that survey, respondents were randomly assigned to express their opinion if in favour or against compensating plasma donors in one of three countries: Canada, the U.S. and Australia. In their brief, reporting on this study, published on August 22, 2018, they write that:
. . . most respondents are in favor of legalizing payments to plasma donors: 72.6 percent were in favor of compensating plasma donors in Canada, 78.7 in Australia, and 76.4 in the United States. Thus, we found no evidence of widespread societal opposition to payments to plasma donors.
That’s the general societal attitude surveyed. If we think about the patient groups that we’ve heard here, the majority of them have expressed pretty significant concerns about the serious unintended consequences of this legislation.
I would love to hear from both of you, who specialize in ethical issues and understand the concept of altruism and the impact. What would you say about the results of this clinical trial and the kind of worries expressed by patient groups who rely on plasma products for their lives?
Ms. Chandler: I’m not convinced from the reading that I’ve done that there will be an erosion of altruism in the presence of a paid system. I know that a lot of people are very concerned that there may be and that this would be a loss. I think, of course, if we have an altruistic system that does not produce enough to meet our needs, we are trading one loss against another. There is no free lunch. There will be a downside either way.
The jury is out on whether there will be a kind of motivational erosion from the altruistic system in the presence of a paid system. There doesn’t seem to be evidence to settle that point. What seems to be the case is that some form of compensation, whether it is reimbursement or something more, reimbursement plus, does seem to be associated with sizeable increases in donation. It may be that there are two different types of populations, one of whom will respond to the altruistic motive and the other who will have a mixed motive or a motive driven solely by the incentive.
I’m not sure that the costs that we’re afraid of will come through.
Ms. Gruben: I would just add that, in terms of the evidence, we do have that study by Lacetera, that there has been quite a bit of work, recent systematic reviews, of the effect of various incentives or rewards. There is some looseness in the language, but according to the most recent systematic review the jury is out on whether or not those are effective, whether they promote one-time donation or prolonged donation.
One the challenges in this area when we’re wrestling with these issues is that the evidence does not firmly point in one direction or another in terms of the impact that these incentives might have.
Ms. Chandler: Another thing that strikes me is that, with the variation in the provincial legislation across the country, we are almost running our own controlled experiment to see what the effects might be. It’s an opportunity to find out, and steps could be taken either way if it turns out that the concerns that are mentioned are seen to arise.
Senator Poirier: Thank you for being here. I have a couple of questions.
I want to go back to your presentation when you mentioned that New Zealand was 90 per cent self-sufficient. I know there are other countries — the United States, Germany, Australia — that are also paying for the plasma. To be 90 per cent self-sufficient, does that mean that that country would keep all the plasma they are collecting and not shipping it out to another country?
Ms. Gruben: That’s my understanding but I’m not an expert in New Zealand’s blood plasma collection system.
Senator Poirier: One of the concerns we have been hearing here is that what the private sector is out there collecting is not staying in Canada. That’s one of the concerns we’ve heard from people who had concerns with the bill.
You talked about the different ways that different countries or organizations are paying to compensate the people who are donating, again, because the time it takes to make a plasma donation versus giving blood can be a cost to the donor.
There are different methods that have been explained. Obviously, there is cash; some has been by prepaid gift or Visa cards. I know in New Brunswick we are seeing it flashed on Facebook where they are offering a certain amount of money. If you go for a certain amount of time, you get a Visa prepaid card. There are also others talking about giving a paid day or half-day off for the person who is going to do it and compensating that way.
What would you say is the best method that would be most apt to get the people to go, or the fairest way, I guess?
Ms. Gruben: I want to be sure I understand the question. I think I’ll tackle it first. I think what you are asking is: If we are going to provide an incentive or payment, what would be the most effective way to do that?
I think that’s an excellent question that I’d love to be able to answer. When we look at the studies that have been done in this area, there doesn’t seem to be a silver bullet. There doesn’t seem to be any one particular strategy that motivates people to donate. The study I’m referring to in particular is by Kathleen Chell and it’s a 2018 systematic review in which they look at a host of academic articles which try to measure the impact of various benefits, incentives and payments on individuals. They take studies from across the world in different jurisdictions.
What that study demonstrates is that some incentives do work in certain jurisdictions and other incentives work in others. In fact, some incentives, like a $5 gift card or a t-shirt may disincentivize donation. The evidence doesn’t point clearly to one particular way to incentivize or motivate a donor.
Senator Poirier: I may have misunderstood, and if I did please let me know. If I understood your comments, you talked about Canadian Blood Services being the best place to collect the blood because they are followed by Health Canada, the security is there and they are well established.
Does that mean that you have concerns that the private sector would not be able to give the same level of security or service?
Ms. Chandler: I’m not sure that’s what I would have said. I think that the reason we are in favour of CBS and Héma-Quebec is that they are established in this field and have the trust of Canadians. At the same time, to the extent there are concerns about the private sector, for example, taking collections too frequently and, perhaps, in ways that might be harmful to donors, CBS presumably would not do that. They would have a policy and apply it uniformly across the country. There are other ways to do that. Some sort of regulation that private collectors would abide by as well would presumably achieve the same objective.
In principle, I don’t think the private collectors could not be run in a safe manner. Again, I’m a law professor and not an expert in the system but it seems to me that it could be done legally.
Senator Poirier: I have the bill in front of me and I know one of you also mentioned that you didn’t think the bill necessarily allowed for some kind of a collector guarantee. But from what I’m reading here, unless I’m seeing it wrong, it says an establishment other than the Canadian Blood Services must not collect. So that’s telling me that Canadian Blood Services would have the ability to collect through the bill as it’s written. I just wanted to put that on the record from what I’m reading and the way I understand it.
Senator Ravalia: Thank you very much. We have heard in previous testimony that attaining self-sufficiency in plasma products in this country at this stage is elusive. Even with a supreme effort from Canadian Blood Services, it’s likely that we will only attain 50 per cent self-sufficiency. So the ongoing need to purchase products from the U.S. or otherwise will be crucial to the survival of the system and to ensure that vulnerable patients receive life-saving products.
From an ethical perspective, can payment to Canadian blood donors be unethical while we continue to purchase plasma products from outside jurisdictions?
Ms. Chandler: This is a tricky problem indeed because if we allow moral qualms about commodification and exploitation to lead us to reject compensation of donors in Canada, we are, in a way, fooling ourselves. We are merely paying donors indirectly on the other side of the 49th parallel and it takes a certain amount of blinders to forget that fact.
I suppose this is not entirely unprecedented. Unfortunately, there are a lot of ways in which we benefit from what people do abroad that we don’t necessarily permit here in order to protect our own citizens. But we have to weigh these questions of concern for our own donors but also concern for the health of our own citizens who need access to these. I have to say that I’m persuaded by the argument of the group of ethicists and economists who wrote in appendix G to Dr. Ballam’s report.
I think there is a common discomfort with the idea of people, especially those who are socioeconomically deprived, giving of their bodies into a system. On the other hand, we tend to be doing this in the context of gametes. We are outsourcing the paid supply of those to the United States. I think we have to confront the hard question ourselves and decide. It seems that the argument in appendix G was that a carefully regulated system that pays attention to ensuring donors are not harmed could adequately reconcile those tensions.
I fear that a blanket ban on compensation, especially worded in its current form, which seems to prohibit reimbursement, removes the manoeuvring room that might be needed for entities like CBS or others to do that fine balancing to try to move in the direction of self-sufficiency. You are quite right that at present we are not anywhere near where we ought to be.
Senator Ravalia: My follow-up question is, by affording this opportunity to CBS alone, are we creating a further monopoly-type situation that excludes all other potential companies or conglomerates that may be interested in this type of business? This is going to cost money for CBS and therefore the provinces and whoever needs to purchase these products. Are we boxing ourselves in when we say it should be a single supply system only?
Ms. Gruben: I’m not an expert in supply and the management of the system. What I can say about Canadian Blood Services is we have entrusted them to be responsible for blood collection across the country. They have done, as far as I can tell, an excellent job.
Senator Ravalia: Absolutely.
Ms. Gruben: I don’t see any reason for not putting our trust in Canadian Blood Services to undertake this responsibility.
To the extent that we might think of expanding or addressing a concern about monopoly, my response would be that I think it’s very important that if we were to go beyond or outside of Canadian Blood Services, that a second not-for-profit organization or provincial body would be best placed to be responsible for plasma collection. I think that addresses a number of concerns that have been expressed that donors could become a revenue stream for private, for-profit companies. Having a not-for-profit organization does address some of those concerns.
Senator Ravalia: Thank you very much.
[Translation]
Senator Forest-Niesing: I want to thank my colleagues for giving me this opportunity. I regret to have to leave the meeting early.
I understand that you have legal expertise. However, while analyzing all this, we can’t completely abandon our review of the potential social impact of the bill.
Ms. Chandler, you said that the bill is a “controlled experiment.” However, I’m wondering whether we can afford to test this area at the expense of patients who depend on the treatments and drugs produced from the plasma collected. I’m wondering about this. I’d like to know whether you agree that this initiative may be a little too hasty, given the reality of the demand for plasma products, which is increasing and will continue to increase; the important science involved in collecting and treating these products; and the fact that, as Senator Ravalia reminded us, Canadian Blood Services is aiming to reach a target of 50 per cent by 2024, if I understood correctly. I want to hear your thoughts on this.
[English]
Ms. Chandler: I didn’t mean to come across as suggesting a controlled experiment flippantly. I think what I meant by this is that this proposed bill, S-252, is not a controlled experiment. We have a controlled experiment already in Canada because we have some provinces that have prohibited paid donation and others that are going ahead with it. We have an opportunity to look at what happens in terms of displacement of altruistic donation, whether there is a good increase in plasma donation in those provinces where it’s going ahead. In fact, this bill would, in essence, put a stop to that controlled experiment.
As for the question of whether we can we do a controlled experiment on the backs of patients, I understand your concern. However I don’t think that is what would happen. As I say, we have a situation of mixed approach where we can now see the effects of those policy differences over the next few years. The shortfall in our supply will continue, as it has in the past, to be made up by purchasing plasma products on the global market, largely from paid American donors. At least in this period, I don’t see any necessary difference the would be felt by patients.
As for this question of an initiative trop hâtive, I interpret you as being concerned that it might be a bit too hasty and I think perhaps it might be. We are in a position now to allow this to play out for a little while and see what happens.
Senator Forest-Niesing: Thank you.
Senator Eaton: Thank you very much, professors. I have a two-part question. Professor Chandler, you talked about improving our patterns of uses. The other part of my question would be about Canadian Blood Services having a monopoly. I see in your biography that your ethical, legal and qualitative empirical research at the cutting edge of advances in biomedical sciences and technology has been funded by CIHR and the Canadian Blood Services. I’m wondering whether that puts you in a bit of a conflict.
Ms. Chandler: I’m not aware that I’m speaking in a way that is meant to promote CBS’s interests. CIHR is distinct from CBS. I hold a chair at the university, the Bertram Loeb Research Chair, which is a privately funded chair looking at organ and tissue donation policy. We actually both have held the Kreppner fellowship from Canadian Blood Services to do our own independent research on organ donation issues in the past. I have always understood myself to be an academic fully entitled to come to conclusions contrary to the interests CBS if my research leads me there. I am able to find funds for my research apart from Canadian Blood Services. I’m glad you did bring this up, though, because I think it’s important for you to know.
Senator Eaton: You have such an impressive resume. It was very pleasurable to read it.
Ms. Chandler: I’m aware that some of the things I have said here are inconsistent with the policy that CBS has charted, which is a 50 per cent self-sufficiency objective. My remarks suggested that is inadequate, ethically, because it commits us to always be an increasing drain on the global supply.
Senator Eaton: When you said in your opening remarks “improve our own patterns of uses,” can you clarify that?
Ms. Chandler: I’m referring to the information that is reflected in Dr. Ballem’s expert panel report that suggests we have a very high per capita usage and other countries are able to use less and cover more conditions.
Senator Eaton: So are we like other highly industrialized medical countries? Do we compare to the U.S. or the G8? Are we advanced?
Ms. Chandler: We are well above the U.K. which is held up as being the model of being quite careful in its usage. The U.S. is the top user. We are second. I think Australia is third.
Ms. Gruben: I believe so.
Senator Eaton: And why is that? We have doctors on this panel. It’s interesting, why do we, why are we so extravagant with blood?
Ms. Chandler: These are actually questions where I think you’ll probably get more useful information from Dr. Ballem tomorrow than from us.
Ms. Gruben: One point that I noted in Dr. Ballem’s report — and I suspect that she’ll be able to answer this question better than either of us. One of the suggestions is that there be more clear clinical guidelines for physicians about when to use these products, when they’re appropriate and when not. I suspect she’ll be able to provide much more detail about that.
Senator Eaton: You don’t feel that a paid system and CBS that have survived very nicely up to now, there hasn’t been a disaster that has suddenly made this bill very necessary.
Ms. Gruben: Not to my knowledge, there hasn’t been a disaster, so to speak. There have been concerns expressed about payment to Canadians through these particular provinces.
Senator Eaton: Apart from that, there hasn’t been medical malfeasance that says we have got to stop this?
Ms. Gruben: No, not that I’m aware of.
Senator Omidvar: We have got two ethicists in front of us, and I’m delighted you’re here to help us through this ethical fog. When we asked the question about the ethics of selling body parts — I’m not quite sure who the witness was — but we were told to look differently at renewable versus non-renewable body parts, and it’s maybe okay to sell hair, plasma and other body parts, but it’s not okay, of course, to sell kidneys and eyes. Could you clarify that for us?
Ms. Gruben: When we think about the distinction between renewable and non-renewable, certainly in Canada we have taken the position with sperm and eggs, which would fall into the category of a renewable resource, that we should not permit payment for eggs and sperm, that we should only allow reimbursement to donors for those particular bodily parts, human tissues.
Across federal and provincial legislation we do see that there has been a fairly consistent approach in terms of prohibiting payment and sale for organs, tissues, sperm and eggs, and to date blood, with the exception of a couple provinces where we see some private for-profit collection.
Senator Omidvar: I noticed with interest your concern about the language in the bill. “Remuneration” or “benefit” may not be interpreted as “reimbursements” or “incentives.” Should we consider language that is more in keeping with what provinces are using so we don’t create more confusion, and we have clarity across the country?
Ms. Gruben: Yes, I think we should. Having clarity around these terms is very important so we know whether or not reimbursement is permitted. That would be a decision for the drafters of the legislation, but it’s important that it’s clear.
For example, when you look at the provincial example, it’s very clear what “payment” means; it’s defined very clearly. Yes, I would advocate for clarity in language.
Ms. Chandler: If Parliament were to go in the direction of passing law consistent with the existing provincial legislation, it would go in the direction of forbidding reimbursement; it would be the least flexibility possible. The questions of consistency and clarity are very important, but clarity in which direction?
Ms. Gruben: Maybe I can give you a second example. In New Zealand, the way the legislation is drafted, there is a provision that clearly permits for the reimbursement of donors where the expense arises, is incurred as a result of the collection.
Senator Omidvar: The legislation, as it’s currently worded, focuses on providing the Canadian Blood Services with a monopoly of paid or unpaid, and if we made that change that reimbursement is allowed, would you think it is advisable to make it generally applicable to Canadian Blood Services and private plasma collectors? Would that cover your concerns?
Ms. Chandler: In discussing this, Vanessa and I have thought it advisable to have a non-profit body doing it. If Canadian Blood Services is unlikely to go in the direction of pursuing full self-sufficiency, it might be wise to leave space for provinces to choose to appoint another non-profit entity to do this in the province.
Senator Omidvar: Thank you.
Senator M. Deacon: First of all, yes, the ethical fog, we’re all trying to work through this, absolutely. My area was totally around the language of the bill and clarity. The previous senator addressed that. Your response is, yes, we should be clear. We should take the time and maybe learn from some of the language of other countries.
The only thing I would add is whether we should be going far enough to define and be very careful about defining and refining the terms we choose to use — reimbursement, incentive, benefits, remuneration. Your response to the previous question is, yes, we should go deeper and clarify. Perhaps I could ask how far we should go with being explicit but not being too restrictive.
Ms. Gruben: I can give you one example. I mentioned it in my opening statement, the regulations under the Assisted Human Reproduction Act, the way the Assisted Human Reproduction Act is drafted is section 12 of that act permits reimbursement in accordance with the regulations, and the regulations set out an exhaustive list of the expenses that can be reimbursed. It’s quite detailed as to what is a reimbursable expense and what would fall outside of the legislation.
Yes, it is possible to achieve clarity. That’s one model you could look to if you were thinking of doing that.
Senator M. Deacon: Thank you.
Senator Kutcher: Thank you so much for being here. I wanted to bring your attention to the actual language of the bill. It says must not collect unless collected is rare.
I’m not an ethicist, but my reading of that is that the moral agency is in the activity of collecting as the issue. At what point does the moral agency change, depending on the phenotype of a blood? Is this collecting moral or immoral?
Ms. Chandler: I’m looking at the provision: “must not collect... for remuneration or benefit ... unless the blood ... is of a rare phenotype.” This is perhaps an attempt to grandfather the entities that have, for a long time in Winnipeg, been —
Senator Kutcher: I want to understand the difference between the moral agency of collecting this and the moral agency of collecting that.
Ms. Chandler: Well, I can attempt a moral argument.
If we recognize this as an ethical dilemma where there may be values on both sides that we’re attempting to balance, one of which is we have to rule out the safety and we have no idea about the distortions to the rest of the whole blood supply and so forth, so we seem to be talking mostly about commodification exploitation risks.
If we balance that against the harm to patients that need the supply, then what this is saying is that where there is an extremely rare phenotype, the balancing is different. We’re willing to pay people and bring forth the supply of a very rare phenotype because we’re less likely to get it on the international system or through our own collection of plasma.
Senator Kutcher: My reading of that is it’s moral unless we decide it’s not moral.
Ms. Chandler: Yes, we’ve chosen to balance different cases differently.
Senator Kutcher: But everything else being equal, it’s just made it an arbitrary decision. That’s food for thought.
Where is the threshold when reimbursement becomes an incentive?
Ms. Chandler: That will probably depend upon the particular donor. I’m not sure I can give a sensible or coherent answer to that question.
Senator Kutcher: Isn’t that a fundamentally important question?
Ms. Gruben: I think it is. I do think it’s a very difficult question and it’s something that we’ve struggled with when we think about donation of other bodily tissues. For example, with respect to some of the living donors with organ donation and sperm and egg, we have to be careful in the way we define what a reimbursement is so that it doesn’t incentivize behaviour.
I think from a legal point of view, the best way to try and approach that definition of reimbursement or to sort out what the category of those reimbursements would be is to really look at whether something is a quantifiable expenditure that is incurred in the course or as a result of the donation. So it arises because of the donation, but for the donation the expense would not occur.
Senator Kutcher: So if someone has to leave work to go for half a day, that could be considered?
Ms. Chandler: I take a slightly different position. You’re asking what the difference is between a reimbursement and an incentive, and I think the answer is whether you have been brought back to a neutral position. Payment of the expenses you incurred in order to give this donation would be a reimbursement. Anything above it would be an incentive.
Underlying the question is the idea that reimbursement might somehow be ethically okay and an incentive not. That’s where I think I might have a slightly different position. I’m not convinced an incentive is necessarily always a bad thing.
For example, we permit incentives in some contexts, so we have to ask ourselves the deeper question, not assuming incentive is always wrong, but asking when and why incentives are wrong. We could start to point at the deeper rationales for avoiding incentives. One might be that there is a safety issue in terms of the quality of supply it brings forth, but that seems to be off the table in this context, according to the evidence.
We could also be concerned about the level of invasiveness, risk and the harm to the donors themselves. I think that’s legitimately something to think about. You don’t want to incentivize people to do things that are strongly against their interests.
We have to look at all of those things and if the conclusion is taken that this can be done safely in a regulated environment, then I’m less concerned about the incentive. I think that others may differ from the way I feel about this, seeing instead something unseemly.
Senator Kutcher: Thanks for pointing that out. That is a fundamental difference.
You talked about having a non-profit organization and it would be okay for them to collect plasma. What’s the evidence that a non-profit organization will actually cause less harm to the donor or do a better job and be more ethical and scientifically appropriate than a for-profit organization? What is the evidence for that statement?
Ms. Chandler: I’m not sure I said that.
Ms. Gruben: I think when we’re thinking about some of the concerns that arise with the collection of blood products by private, for-profit companies, one of the suggestions I have to address those concerns is to charge a non-profit organization with that collection. Safety is off the table. I certainly don’t want to be seen as arguing that this would be a question of safety.
I do think, though, that to the extent that there are concerns about private, for-profit companies and whether the plasma would stay in Canada, whether it would go on the market, whether it would leave and how it would be managed, I think many of those concerns can be addressed by charging a non-profit organization with managing this.
Senator Kutcher: It can’t be done by a for-profit organization?
Ms. Gruben: I’m not saying it can’t be done. I’m suggesting that if there are concerns, a non-profit organization addresses those concerns. Certainly, we could regulate the private, for-profit companies in a way that I understand is not occurring at the moment. There is certainly room for regulation to address those concerns, but another alternative could be a not-for-profit.
Senator Dasko: My questions follow up on Senator Kutcher’s questions to some extent and get back to the issue of reimbursement versus incentive.
One of the things we’ve heard is that donation of blood plasma is a lot more laborious and takes a lot more time than to donate blood, for example, or perhaps other kinds of activities.
Let me explain a little situation to you. I used to be in the survey research business. When we called people to do surveys for 10 minutes on the phone, we didn’t pay them. But if we were to ask them to come out to a focus group, that was a lot different. They have to take the time. They have to get on the bus. They have to go to the group. They have to take the time for three or four hours or whatever. We could never get them without reimbursement/incentive.
If I can make a comparison here, we’ve been told that there is a lot more involved in doing this. Does that not justify paying people? We could never get people to do this unless they were paid. We didn’t call it reimbursement or incentive; we called it an honorarium. It leaves it a little bit fuzzy as to what the actual nature of this is, but they were taking their time. They were not, as far as I know, taking time off work, but they were taking their time.
I’m just exploring this concept a little bit more in terms of whether it is justified to pay them whatever it may be, beyond, or somewhat beyond actual reimbursable expenses, like the bus fare to pay them for coming and doing this. Is that not justifiable? How can we get them without that, really? I think supply is part of this issue too. We’ve been talking about it in various contexts and how do we get people to come and do this. It’s just not going to be pure altruism.
Ms. Chandler: You’re making me think of the kind of empirical research I do where, of course, we go to our research ethics board. I wonder if we can learn something useful from research ethics for the question that’s facing you.
I do social scientific research and the kind of risks faced by my subjects are very low. They come and talk to me for a bit, which some people might think is a risky proposition.
Ms. Gruben: I can assure you it’s not.
Ms. Chandler: It’s fairly safe. When I’m trying to recruit participants for focus groups or interviews, I’m asking busy people to give me an hour or two and, in a way, there is the practical question of whether they are going to be willing to do it if there’s not something in it for them. But there’s also a kind of fairness question. I’m taking their time, so should I give them something to counterbalance that?
In the research ethics context, regarding the amount of the honorarium, the concern is in ensuring that you don’t have an undue inducement to people to run a risk to themselves. You want to make sure that you’re recognizing their contribution and giving them sort of a sense that it’s okay and they’re willing to give of themselves and their time without, then, getting a certain group of vulnerable people to be induced to run a risk to themselves.
This rarely comes up in my research because there is not really a risk to people in my work, but I think in biomedical research, where there might be some risks, that’s a live issue. There is a significant amount of thinking there about the size of the money or other inducement that can be provided while being ethical.
In a way, what we’re talking about here is a kind of contribution that is actually less risky to donors than some biomedical research, so it might be a fruitful place to go and look. I hadn’t thought before to think about the research ethics of reimbursement or incentive in the context of this bill.
Ms. Gruben: The only point I would add is you asked how do we get the donors if we’re not going to pay or incentivize them.
Senator Dasko: They’re being paid now in certain places.
Ms. Gruben: But how would we get them if there were no payments.
One of the things we need to stress is the importance of public education in terms of promoting donation. We look at public education campaigns around donating blood altruistically. That might be an area we can think of in terms of how we can get people to donate altruistically. Public education is one piece. There’s no question we need to go to great lengths and make great efforts if we’re going to operate an altruistic system. We need to take steps in order to encourage donation. That would be the only thing that I would add to Jennifer’s comments.
Senator Dasko: I have worked in that field, too, and it is exceptionally difficult.
Can I ask about the second part of what Senator Kutcher suggested? He suggested it takes it back to the private sector. If people are running a risk, then, of course, the suggestion is that the private sector is going to be exploiting people. Do we not have vast regulations in the private sector when it comes to supplying products and services to the health care system, such as pharmaceuticals? Maybe that’s a bad example, but it’s a huge one in terms of private sector involvement in health decisions.
We regulate every supplier to the public system. Why can we not regulate private sector suppliers in this area? And we do, because they’re tested. They have regulations in terms of the frequency with which people can come and give blood, et cetera. As far as I know, every aspect of it is highly regulated. Can you please comment?
Ms. Chandler: In principle, I don’t see a reason why we couldn’t do that. There is the question that was raised earlier about whether a private collector is going to be required to deliver plasma to a fractionator who is going to then make sure it comes back to Canada. I’m not sure if that’s in the current regulations. I think that’s a bit of an awkward point, particularly because it would mean that we would say, “yes, you can collect it,” but it’s all got to come back home.
It sits uncomfortably with the fact that we’re busily buying it from the United States. Others are willing to supply it to us, to have a regulation that says every ounce of plasma collected here has to come to Canadians only. It’s another ethical sore point that, I have to say, needs to be confronted.
Senator Moodie: Thank you, Professors Gruben and Chandler. I want to take this back to the beginning, about the ethical question, because I’m really struggling with this. We talked a lot about remuneration versus honorariums versus incentives. That bothers me less.
Let’s start with whether whole blood collected in Canada is paid for anywhere. Is whole blood collected and paid for anywhere in Canada? I would say the answer to that, if I am correct, is no.
Ms. Chandler: I think that’s correct, yes.
Senator Moodie: So we’re starting with that clear understanding. We’re on the same page.
What is the difference and what is the ethical consideration that brought us to that situation where we do not allow whole blood to be paid for? It is an altruistic exercise. Blood is considered to be part of the public good.
We have heard from speakers who have presented to us that, in fact, there is a lot of concern in their minds about trust and safety. Some of it is not backed up with more than just an emotive sense from these people.
I want us to talk a little bit about how we reached this decision that we would not collect whole blood for payment. What’s different? Plasma is a piece of blood. Blood is treated as, if I use your language, a nonrenewable product when, in fact, it is. But it is treated as a body part. In the fullest context, it’s treated as a body part. It’s not paid for. Why should we be looking at plasma differently? What is the ethical consideration that brought us to blood being treated this way and why are we looking at it differently for plasma? I’m struggling with this.
Ms. Chandler: I suspect that the explanation for the whole blood is the Krever Inquiry and the concerns about safety. It was probably at the same time as the concern about the buying, selling and commodification of human body parts. I think that is probably the explanation for whole blood.
As I understand it, producing plasma-derived products requires a tremendous amount of plasma, while our need for whole blood is going down. Because we meet the whole blood requirements, there is not necessarily a pressure to revisit the approach we’ve taken to whole blood.
Senator Moodie: However, not to interrupt you, but we’ve heard over and over from you, as well as previous speakers, that, in fact, the understandings and criteria on the use of plasma products have yet to be tightened up. Right now, it is being used more liberally without scientific evidence and basis for use, and we are one of the largest consumers in this area.
Again, I’m struggling with why we think this is different. I think that the people we’ve been hearing from who talk about blood and plasma as a public good, that’s their argument. I’m trying to understand how we see the distinction differently.
Ms. Chandler: I’m suggesting that there is not a “coherent” distinction being made, or one to be made, but instead there is the different pressure of supply and demand differences for the two products.
Senator Moodie: But we are acknowledging that perhaps we need to clean up the supply. Supply is one thing, but the demand side is not clear yet. That’s still evolving.
Ms. Chandler: It appears we could be reducing our demand.
Senator Moodie: Yes. The other question that we heard about was perhaps another ethical consideration. That is, in the event of an acute shortage, such as a contaminated supply or a major clinical event that required massive use of plasma products, are we certain that the private collectors could be forced through regulatory measures to make their products accessible to Canada?
The argument that’s being made on the other side is that if it’s controlled by the state or if it’s controlled by an organization such as CBS, that they would control the resource; that in the event of some sort of calamity or major disaster, they could redirect those resources and have full control over them.
Now, using your legal knowledge in this area, is there regulation that could actually force collectors who send their product outside of the country to bring it back here?
Ms. Gruben: In principle, I can’t see why we couldn’t have a regulatory framework to require a company to have sufficient product to supply the market or to meet the demand. In the case of an emergency I can’t see, in principle, any reason why we couldn’t put such a regulation in place. You were talking about people’s concerns and their feelings about this. Again, this is one of the reasons why I think some people are advocating for having either Canadian Blood Services or a not-for-profit organization who would undertake that role. In principle I can’t see why we couldn’t regulate.
Ms. Chandler: I seem to recall reading in this report — and I wish I could remember where it is — one of the private collectors in Canada had approached CBS wanting to provide their collected plasma to CBS. This is another model that would allow for control.
Ms. Gruben: There is certainly a way to regulate.
Senator Moodie: Thank you.
Senator Munson: Very unusual for me to be quiet but the conversation has been very good. A simple question: From your ethical point of view in law, is this a good bill or a bad bill? Is this bill necessary?
Ms. Gruben: The question may be simple but the answer may be more complicated.
Ms. Chandler: I regret to say that I’m not super keen on the bill as written. I think that it takes a simple approach to a complicated problem. I don’t think a bill in itself is necessarily a bad idea, but I am sure that I don’t think this one has got everything in it that would be optimal.
Senator Munson: Appreciate that.
Ms. Gruben: I agree.
Senator Munson: I don’t want to sound like Perry Mason here. Maybe there is a young audience out there who doesn’t know who Perry Mason is.
Ms. Gruben: Not that young. I think I raised this in my opening comments and in response to a couple of questions, I do think further clarity is needed in the bill to flesh out exactly what would be permitted and what wouldn’t. As I think is clear from my comments, I think reimbursement should be permitted and that would require more details in this proposal.
Senator Munson: I appreciate that. I always hate putting people on the spot.
The Chair: Thank you both for not shying away from a tough question.
Senator Kutcher: I want to thank you. I’m actually very much enjoying your testimony. The thoughtfulness and the critical thinking. With that being said, a couple of questions.
Ms. Chandler: Here it comes.
Senator Kutcher: I think this is interesting for us to grapple with: Does a person’s time have a monetary value apart from that portion which is taken by their paid employment? If the answer is yes, then why can they not simply, by the allocation of their time, receive a monetary benefit? That’s my question.
Ms. Gruben: When we think about the definition of these terms — is something a reimbursement or not, or is it an incentive — I think that’s an excellent question to determine is this something that, if we were to adopt a reimbursement model, would not be motivating somebody, but would be leaving them in a neutral position. How we quantify that, going back to my definition of what a reimbursement may look like, I think it becomes a lot more difficult. It’s an excellent question. Is that something that we can quantify as a reimbursement or does it become an incentive? If it is, is that the approach we want to take, that we are going to permit incentives and, if so, what kind? Which I think is what we have been discussing.
Ms. Chandler: To answer the question does a person’s time have a monetary value apart from paid employment, I think it certainly has a value. Does it have a monetary value is a separate question. We have to ask is there a market in which we are willing to exchange their time for money apart from paid employment. I think the answer to that can be yes, but whether we want to allow that exchange depends very much on other things.
We could say, how were you going to spend that time we are proposing to exchange money for? I think we can all imagine kinds of activities or things that we would not think it’s appropriate to exchange with them. So if you were to, agree to give me your corneas or something like that, there would be time taken in the surgery and the kind of recovery and things like that, but you would be left blind. Yes, your time there has a monetary value, but I don’t think it would be appropriate for me to exchange that time for money.
Senator Kutcher: If that was the only issue.
Ms. Chandler: Is there a risk, is the person going to exchange time and get a bit of money but also significant harm to themselves is an issue.
Senator Kutcher: That’s the second question I have. We have heard discussions about vulnerable people and harm to people, and we need to have structures in place that don’t prey on vulnerable people. So who are these people who are donating plasma? Are they vulnerable people?
Ms. Chandler: I think that we actually need a lot more research on this.
Ms. Gruben: I don’t think we know who those people are. In the other fields in which I research, for example, surrogacy, this is a big question. We don’t know who these people are and therefore we don’t know if they are being harmed or if there is exploitation going on. We don’t know. I think it’s incumbent upon us to find out.
Senator Kutcher: With a grant?
Ms. Gruben: With some funding from the CIHR. As far as I know, there are anecdotal reports about who is being paid to donate plasma in the U.S. But as far as I know, there is no qualitative study of who is donating in our jurisdiction.
Ms. Chandler: Whether it’s exploitative is another question.
The Chair: Thank you for this precision. Unless I have other questions, I think we are very thankful for your time. As Senator Kutcher said, it’s been very interesting, helpful, useful and relevant to the study we are conducting on Bill S-252.
Tomorrow we will continue. We are going to have with us the former of chair of the Health Canada expert panel on immunoglobulin product supply, Dr. Penny Ballem. We are going to have Canadian Blood Services and Héma-Quebec.
(The committee adjourned.)