THE STANDING SENATE COMMITTEE ON SOCIAL AFFAIRS, SCIENCE AND TECHNOLOGY
EVIDENCE
OTTAWA, Wednesday, February 20, 2019
The Standing Senate Committee on Social Affairs, Science and Technology met this day at 4:15 p.m. on Bill S-252, Voluntary Blood Donations Act (An Act to amend the Blood Regulations).
Senator Chantal Petitclerc (Chair) in the chair.
[English]
The Chair: Good afternoon, everyone. Welcome to the Standing Senate Committee on Social Affairs, Science and Technology.
[Translation]
My name is Senator Chantal Petitclerc from Quebec. I am pleased to be chairing today’s meeting.
[English]
Before we give the floor to our witnesses, I would like to invite my colleagues to please introduce themselves, starting with the deputy chair.
Senator Seidman: Judith Seidman, Quebec.
[Translation]
Senator Forest-Niesing: Good afternoon and welcome. Josée Forest-Niesing from Ontario.
[English]
Senator Ravalia: Mohamed-Iqbal Ravalia, Newfoundland and Labrador.
Senator Manning: Fabian Manning, Newfoundland and Labrador.
Senator Dasko: Donna Dasko, Ontario.
Senator Munson: Jim Munson, Ontario.
Senator Omidvar: Ratna Omidvar, Ontario.
Senator Tannas: Scott Tannas, Alberta.
Senator Deacon: Marty Deacon, Ontario.
[Translation]
The Chair: Thank you. Before I introduce our witnesses, I would briefly like to raise two points. Today, we are holding our first meeting in our new location, and we love it already. I would like to thank all those who have worked so hard on our new facilities and have helped with the many tests of the equipment in this room, to be sure that it all works well.
[English]
Second, I would like to share a piece of information on the good work we do here at SOCI. You may remember last summer a documentary entitled Mum’s the Word was filmed to shed light on forced adoption in Canada. Former Senator Eggleton appeared, and myself a tiny bit. This is to highlight forced adoption and the study we did.
I’m happy to let you know that the producer of Mum’s the Word has received funding from both the Ontario Arts Council and Canadian Council for the Arts to create an online educational platform on the adoption mandate based upon the lived experience of mothers and adoptees.
I thought I would share that with you. When I learned about that, I was quite pleased. This, as you can see, aligns well with the recommendation that was made in our report.
[Translation]
Today, we are continuing our study of Bill S-252, Voluntary Blood Donations Act (An Act to amend the Blood Regulations).
[English]
I would like to thank our witnesses for being here. Please introduce yourselves and the organizations you represent.
Joshua Penrod, Senior Vice-President, Source and International Affairs, Plasma Protein Therapeutics Association: Good afternoon, everyone. Thank you, Madam Chair and honourable senators. My name is Joshua Penrod. I’m Senior Vice-President of Source and International Affairs at the Plasma Protein Therapeutics Association, or PPTA. We’re the trade association that represents more than 700 source plasma collection centres in North America, including here in Canada and in Europe, as well as the manufacturers of the finished therapies.
David Page, Member, Board of Directors, Network of Rare Blood Disorder Organizations: I’m representing the Network of Rare Blood Disorder Organizations, which is a coalition of patient groups whose members have rare blood disorders and who need either blood or plasma products for their health and survival.
Whitney Goulstone, Executive Director, Canadian Immunodeficiencies Patient Organization: Good afternoon. I’m the Executive Director for the Canadian Immunodeficiencies Patient Organization. I’m here representing patients with primary immunodeficiencies in Canada.
The Chair: Welcome. I’d like to remind you that you have seven minutes for your opening statements. They will be followed by questions. We will begin with you, Mr. Penrod, to be followed by Mr. Page and Ms. Goulstone.
Mr. Penrod: Thank you once again, Madam Chair and honourable senators.
I’d like to start by noting the most important fact here: Plasma is the primary building block of many life-saving therapies that treat patients with chronic and rare diseases, including immunodeficiencies; Guillain-Barre syndrome; CIDP; alpha-1 antitrypsin deficiency; hereditary angioedema; and clotting disorders, such as hemophilia and von Willebrand disease. Canada is a world leader in the treatment of these diseases and in the level of access it provides to patients in need of plasma protein therapies.
In considering policies, we would urge you to enact those which maintain or further improve the existing high standard of care that Canadian patients currently enjoy.
As a corollary to this, the need for a system to be in place to collect the source plasma needed to provide life-saving therapies for patients in Canada and around the world has never been more important. Plasma is collected from human donors through a process called plasmapheresis, which collects only plasma, leaving behind the other components of blood. This is usually called source plasma and is only used as the starting material for many therapies; it is never used for transfusion, which is a critical distinction.
Around 75 per cent of the source plasma in the world comes from compensated donors. To emphasize: The process we are talking about today is completely different from blood donation, which takes around 20 minutes and can be only done every eight weeks. No one here is talking about paying whole-blood donors. I want to be very clear on that point.
A dual system of compensated plasma donation and non-compensated whole-blood donation does and should coexist.
Health Canada’s own Expert Panel on Immune Globulin Product Supply and Related Impacts in Canada, the findings of which were released in 2018, takes the position that compensated plasma donation is necessary to meet the needs of patients, noting in its report that:
Jurisdictions that permit payment of source plasma donors have a significantly higher plasma collection capacity on a per capita basis compared to those jurisdictions where compensating source plasma donors is prohibited.
You will hear from the proponents of this bill that private plasma collectors take advantage of donors or are somehow unethical. These concerns are misplaced. One can still be motivated to donate one’s plasma in order to help patients while at the same time receiving a fair and modest compensation for the time commitment. I have a letter, which I believe you have already received, from 31 ethicists and economists, including two Nobel Prize winners and several Canadian intellectuals, that stresses the ethical compatibility between plasma donation and compensation. It notes that the amounts of money in question make a meaningful impact on a household budget but are not so great that a donor would feel compelled to donate.
In addition to this, in 2011, the U.K. Nuffield Council on Bioethics declared compensated plasma collection to be ethically acceptable, given the rarity of the diseases, the importance of treatment and the quantities of source plasma needed to create the finished products.
Depriving a donor of a safe and legal way to augment their income, while at the same time helping patients, does not seem to be a more ethical position to take.
You have heard about the concept of self-sufficiency or the idea that a country should be able to, completely on its own, collect the enormous amount of plasma required to treat patients. To date, the only countries in the world that have achieved self-sufficiency are those that compensate donors. Some countries will claim to be approaching self-sufficiency, but that is often due to a smaller amount of product used in the country because of restrictions placed on access or a lower standard of care. These are hurdles that Canadian patients do not face.
I would suggest that self-sufficiency does not need to be a goal at all. Patients who rely on access to plasma protein therapies are, in turn, reliant upon countries to facilitate the safe and plentiful collection of plasma. The more plasma that is available worldwide for manufacture into these therapies, the more that will be available to Canadian patients.
Over the last decade, our industry has collected over 300 million donations from healthy, qualified donors, an enormous undertaking, representing the vast majority of plasma used to make these therapies and one that could not have been achieved without compensation. To give some context to the number of donations needed, it requires 900 plasma donations to treat one alpha-1 patient for one year, and 1,200 to treat one patient with hemophilia A. Third-party estimates suggest that in order to meet clinical need, around 75 million litres of plasma need to be collected per year by 2024. This is roughly a 50 per cent increase. This is not a time to limit the options available to meet this need.
In her testimony, Senator Wallin referred to the Krever Commission that investigated the tainted blood scandal in Canada. We recognize the important role that the findings of the commission played in modernizing the blood system here. That said, the report was written using the facts of the day — the facts as they stood over 20 years ago. The industry has changed radically in that time. Safety processes that were just beginning to be understood then are standard fare today. Plasma donation, whether the donor is compensated or not, is heavily regulated, in addition to voluntary industry standards adhered to by all by PPTA member companies.
Current measures in Canada for quality assurance and safety are rigorous and effective. As a result, there has been no viral transmission of any kind through a Health Canada- or U.S. Food and Drug Administration-licensed product in over a quarter century.
Reference has been made to this committee of compensated donation impacting non-compensated collections. There is no evidence that the use of compensated sources are crowding out voluntary donation. Germany has had great success collecting plasma from compensated donors, with no effect on non-compensated collections. Just two weeks ago, at a meeting of the European Directorate on the Quality of Medicines, German transfusion experts showed data that further illustrate the fact that plasma donors and blood donors are two separate populations, with very little overlap.
In another example, the U.S. collects the majority of the world’s source plasma from compensated donors, while still maintaining a world-class whole-blood supply.
Finally, Health Canada’s expert panel found no evidence of such an adverse effect on non-compensated donation.
I understand why some may be inclined to support this bill at face value, based on a belief they are doing so for altruistic reasons. However, that reasoning is not based on evidence. Certain provinces have fallen into this trap. We are urging the federal government not to do the same. As senators, you have a unique opportunity to look at this bill through an evidence-based lens. Please do so, because the evidence shows that the current system is keeping patients alive and healthy, with a superior quality of life. Thank you, and I look forward to your questions.
The Chair: Thank you. Mr. Page, please go ahead.
Mr. Page: Thank you again, Madam Chair. Perhaps I can just give you a little more background on myself. I was the President of the Canadian Hemophilia Society during the Krever Commission. As you know, the hemophilia community was decimated by HIV and hepatitis C through tainted blood. I myself was infected with HCV, but I’m well today. I have scores of friends and colleagues who were not so fortunate.
I’ve been working for the Hemophilia Society in blood safety since the 1980s. For 16 of the last 18 years, I chaired the Coagulation Products Safety and Supply Committee of the World Federation of Hemophilia. In the early 2000s, I was President of the Quebec Hemovigilance Committee, which directly advised the Quebec minister of health on blood safety issues. I have been a member of the Héma-Québec safety committee since 1998, representing the public, and am currently its chairperson.
I participated in all of the Dublin consensus conferences, and I shared some of those findings with you.
Finally, I’m a founding member of the Network of Rare Blood Disorder Organizations. I sit on their board of directors. I’m speaking on their behalf today.
I must also state that the NRBDO and its member organizes have no relationship, financial or otherwise, with Canadian plasma resources. The NRBDO and some of its member organizations do have relationships with a number of other pharmaceutical companies, some of which manufacture plasma products. We’re proud of those transparent and ethical relationships.
It has been suggested that we would allow financial sponsorship to blind us to the health and safety needs of patients. There is no evidence for that, and I find it, frankly, insulting.
If you’ve read the position papers we have submitted, you may be surprised to learn that we largely agree with the crux of your draft bill. It reads “an establishment, other than Canadian Blood Services” — and I think you’ve forgotten Héma-Québec — “must not collect allogeneic blood for remuneration or benefit for the donor . . .”
I, the NRBDO and its member groups — indeed, all the patients groups I know around the world — would agree that there should be no remuneration for the donation of allogeneic whole blood, platelets and plasma for transfusion for use as fresh components. This should remain a public resource, collected without cash payment and distributed free of charge by Canadian Blood Services and Héma-Québec.
We also agree that the Canadian Blood Services and Héma-Québec should do all they can to collect more plasma for fractionation from non-compensated donors. We just don’t believe those efforts will come close to meeting the goal of even limited self-sufficiency.
Where we disagree is the inclusion in the bill — if this is what you intend — of plasma for manufacture into plasma products. The blood and plasma sectors are completely different in the products they make, their collection practices, recruitment realities, supply chain, reimbursement and even safety procedures. Safety is my next topic.
Proponents of the bill have often raised the spectre of the tainted blood tragedy. To state that plasma products made from the plasma of compensated donors are less safe than those made from non-compensated donors is not only false, it’s dangerous and irresponsible. It can instill fear into the hearts of vulnerable people who need to infuse these products for the rest of their lives. The risk is that they will avoid vital treatment. Please don’t take my word on safety. Ask the regulators — Health Canada, the FDA, European Medicines Agency — and you will get the same answer. Based on 25 years of data, plasma products are of equivalent safety and quality whether made from compensated or non-compensated donations.
In fact, the safety measures put in place by the plasma products industry since the tragedies of the 1970s and 1980s surpass those in place for fresh components. How is this? First, donors must qualify according to the same eligibility criteria. All donations, whether whole blood or plasma for fractionation, are tested for the same pathogens with both ELISA antibody and nucleic acid testing. Now this is not what was said in some of the remarks to the Senate. Plasma for fractionation undergoes a second series of the same tests before the plasma is introduced into large pools for manufacture. Moreover, each plasma donation is frozen and placed on hold for a period of time in case a person becomes ineligible at a subsequent attempt to donate.
Finally, and most importantly, plasma products undergo extremely effective pathogen reduction processes during manufacturing: solvent detergent, heat treatment, nano-filtration. Fresh components cannot yet be subjected to such safety measures, and when an emerging pathogen, for example, West Nile or Zika virus, to name just two, is identified, the pathogen reduction processes are tested to ensure they are effective.
In the end, however, the proof is in the pudding. The many thousands of recipients of blood products are tested for known pathogens and no case of HIV, HCV, HBV, West Nile virus, Zika, et cetera, is known to have been transmitted by plasma products in the last 25 years.
As for emerging pathogens for which there is no test, they are much more likely to infect recipients of fresh components, which do not undergo the same rigorous pathogen inactivation compared to recipients of plasma products. I’m very happy to say and report to you that 2019 is not 1984. The bill before you might have helped the safety of the blood supply 35 years ago. It doesn’t today.
If the objective of the bill is to ensure that Canadians receive plasma products from non-compensated donors on the pretext of safety or ethics or protection of the public blood collection system, it’s doomed to fail. Canadian Blood Services and Héma-Québec distribute over 40 different plasma-derived medicinal products to Canadian hospitals and patients. The plasma currently collected by these agencies is sent to two or three large multinational pharmaceutical companies in the U.S. and Europe for fractionation. Only four finished products — immune globulin, albumin, factor VIII with von Willebrand factor and fibrinogen — are returned. The other 40-odd products will continue to be manufactured by other companies or on different production lines and will all be made from plasma from compensated U.S. donors.
So, yes, let’s collect more Canadian plasma. Let’s not fool ourselves that we can or even want to become self-sufficient. This is a global industry.
I notice that the bill allows payment for donors with rare phenotypes. I assume this is to exempt Emergent BioSolutions — now ProMetic Plasma Resources — in Winnipeg, which for the last 30 years has been paying its donors for plasma to make WinRho for RH negative mothers. I fail to understand why compensating these donors is good, while compensating all the other donors whose plasma contains different lifesaving proteins is bad.
While the import of plasma products from paid donors in the U.S. in the 1980s, at a time when little or no controls were put on the donations, certainly increased the risk to hemophilia patients for HIV and HCV, anyone who has read the Krever report knows that the root causes of the tragedy were lax regulations, decisions to save money or to satisfy ideological considerations, mostly Canadian self-sufficiency, and political interference.
Bill S-252 is a good example of legislation with worthy goals. However, it is misinformed and will have unintended negative consequences, notably condemning Canada to be overreliant on American plasma and exacerbating the inadequate world supply of essential medicines like immune globulin. I urge you to let this bill die. Thousands of patients in Canada and many more around the world count on an adequate supply of plasma.
I submitted a number of documents to the committee. I’m happy to answer your questions.
The Chair: Thank you.
Whitney Goulstone, Executive Director, Canadian Immunodeficiencies Patient Organization: Thank you, esteemed members of the committee, for allowing me to appear today. Thank you for taking the time to review this bill, listen to experts and understand what is really happening. I’m not a medical professional or a scientist, therefore I’ll leave the medical and scientific aspects of this argument to those more qualified.
On behalf of the Canadian Immunodeficiencies Patient Organization, I’m here today representing the 30,000 Canadians living with primary immunodeficiency disease, or PI. I myself am a patient and I depend on a plasma-derived product to live.
CIPO is not affiliated with any company currently compensating donors in Canada. CIPO does receive industry funding which we disclose publicly. The suggestion or assumption that any individual funder or funds can influence or sway CIPO’s board or staff from its mandate is false. As a patient, current executive director and someone who has dedicated the last decade and a half to patient advocacy I find any accusation otherwise hurtful and petty.
There has been a lot of news recently about measles outbreaks. Like most people, I was inoculated as a child. However, unlike most people I did not mount a response to it. What should be simple, everyday things, like going to the grocery store or taking your child swimming, become terrifying and life-threatening. Unfortunately, this is the world that PI patients live in.
Our only hope is the lifelong reliance on plasma-based medicinal product immune globulin replacement therapy, or IG. Thirty-five per cent of the world’s plasma is used to treat PI patients. IG therapy is the only course of treatment for the majority of PI patients. There is no alternative. Science and technology have nothing in the pipeline for us. There’s no biologic, generic or recombinant alternative coming.
Science and research have brought us here. Whether given intravenously in hospital every three to four weeks or at home, under the skin, one to four times a week, PI patients across Canada rely on IG therapy for a number of reasons. These include reducing the number of infections or reducing the severity of infections, reducing the number of hospitalizations or increasing quality of life or increasing life expectancy.
Currently Canada, through Canadian Blood Services, only collects enough plasma to supply 14 per cent of our needs. With no change to how they are currently collecting, that number will drop to 10 per cent by 2021.
As you know, the vast majority of Canada’s plasma needs are met on the global market, with a large dependence on the United States. Canada currently purchases 45 brands, costing the provinces a total of over $600 million a year and rising. These products are made with plasma collected from compensated donors.
CBS’s current business plan — not yet approved by the provinces — hopes to increase Canada’s plasma supply to 50 per cent sufficiency with regard to IG requirements in five to eight years. CBS has stated they are committed to an unpaid voluntary donor model. In order to achieve this goal, CBS will need to recruit between 200,000 and 600,000 new plasma donors. This will be in addition to the ongoing recruitment of 100,000 whole blood donors needed each year.
We’re aware that CBS has an exemption to compensate in the proposed bill in special circumstances. However, it is vital this committee understands this is not a one-off urgency. We’re hearing terms like “challenge,” “strain” and “disruption” in regard to IG supply currently and this is scary. No one wants to use the term “shortage” and panic everyone. However, there is agreement of a looming IG supply crisis. IG demand continues to outpace collection and fractionation.
Unlike conventional medication, it takes roughly 18 months from collection to fractionation to finished product.
When there’s a shortage, there is no whipping up a new batch quickly. The demand for IG is growing in Canada on an average of 10 per cent per year over the last five years.
We want to see the CBS plan succeed. We will do what we can to work and support CBS going forward. However, we believe their plan is currently ambitious, not cost-effective, and is unlikely to succeed without compensation in some format.
The idea of compensation for a donor is not new and is practised in Canada and around the world even in countries that have outlawed paid donations.
The European Commission to the European Parliament felt it important to distinguish between compensation and incentive when discussing blood and plasma donors.
In this somewhat arbitrary and unclear distinction, more than half the EU member states compensate donors in the form of time off work and reimbursement for travel costs. While the amount varies by country between 25 euro to 40 euro, as does the time, between half a day to two full days, the principle of compensation remains the same.
Another popular form of compensation among 24 EU member states is a small thank-you gift for their donation, ranging in price between 1 euro and 10 euro. Gifts can include movie tickets, festival passes, free events, T-shirts, mugs, towels, meal vouchers and museum passes. One country also reported a small tax deduction equal to 10 euro per donation up to 50 euro per year.
As Canadians we like to pride ourselves on our altruistic giving. In reality roughly 3 per cent of the adult population are blood donors.
The truth is when we in Canada hear the term “paid plasma,” an image is conjured of an American way of conducting things where cash is handed over for blood. This could not be further from the truth.
Similar to the EU model, donors are compensated for their time. They are most often given reimbursement on special e-debit cards or rewards cards between $20 and $50. This direct payment from the clinic rather than reimbursement through the employer or health insurer as in the EU model is the cause for the cash-for-blood furor. These compensations are reimbursing donors for their time, and it is time-consuming. Donating plasma can take up to two hours.
The U.S. currently supplies over 70 per cent of the world’s plasma, and it is feeling the global strain. Emerging Asian markets and growing global demand is revealing pressure.
Starting in 2018, patients reported product unavailable at pickup. This is happening in the U.S., UK, Romania, South Africa and could soon happen here.
It has taken CBS 20 years to build their whole blood donor base. We do not have 20 years to wait while they build their plasma donor base.
We urge this committee to consider the long-term ramifications to patients who depend on plasma products if this bill is passed. We hope this committee will do anything they can to avoid serious health complications and deaths in the future. We urge you to oppose this legislation.
Senator Seidman: Thank you very much for your presentations.
Mr. Page, you come with a certain degree of enormous history and expertise. It must also be extremely emotional for you to be sitting here testifying. Thank you for making the effort to be with us. I really appreciate it. I say the same, of course, to you, Ms. Goulstone, and Mr. Penrod. This is a challenging issue. We want to do the right thing.
I would like to review a couple key points about the final report of the Expert Panel on Immune Globulin Product Supply and Related Impacts in Canada, protecting access to immune globulins for Canadians, and that was the Health Canada expert advisory panel, publication date May 2018.
This was an expert panel. They consulted widely across this country — patients, patient groups, health providers, policymakers, Canadian blood operators. I would like to read a couple of points that they make. I’ll just take them out of the executive summary, and if I might impose upon you to comment on them.
First, they say that a safe and secure supply of blood and related products is a cornerstone of the health care system. In 2016-17, the combined volume of plasma collected by Canadian Blood Services and Héma-Québec only accounted for 16.7 per cent of the plasma required to meet the needs of Canadians for IG and other PDPs. The rest of the plasma for making these products used by Canadians were collected in the U.S. from paid donors.
They then go on to make their two key points to try to satisfy the two big issues about safety and supply. What they say is that for patients and their representative organizations, given the remarkable safety record of IG and PDPs over the last 20 years, the major concern is not the issue of using paid donors but relates to ensuring an adequate supply of plasma for patient needs, which they view as the paramount safety risk. Their position is that both paid and unpaid donors are necessary to ensure an adequate supply of IG and other PDPs for patients.
They go on to say that across Europe, Australia and North America, the only jurisdictions that have achieved 100 per cent self-sufficiency for plasma collection are those that have permitted paid plasma donors. Jurisdictions that permit payment of source plasma donors have a significantly higher plasma collection capacity on a per capita basis.
Basically they are addressing the safety and supply issues. I know you have all made reference to this report. This report is a critical and important piece of evidence we need to consider. I would like you to speak to those two points if I might impose on you.
Mr. Penrod: We agree with those findings. It’s something we have been talking about, as an industry, for quite some time. Over the past couple of years, our refrain has been that the world needs more plasma. We are firmly behind the strong idea that, in fact, more people do need to donate plasma. Of course, as an industry, we don’t discriminate between paid or unpaid. We like to make sure that the donors are healthy, the plasma is safe and can be made into finished products for patients. Those findings in the report are, in our opinion, very critical.
Mr. Page: One of the co-authors of that report, was Francine Décary, who was the CEO of Héma-Québec, who is a person who spent her lifetime in the not-for-profit volunteer, unpaid system. Nevertheless, her conclusion in that report was that CBS and Héma-Québec will not be able to collect even 30 per cent or 40 per cent of the need for plasma for IG with their current plans. We have to be open to alternatives.
Perhaps we can talk later about those alternatives because it’s not just an either/or voluntary or paid; there may be some public-private partnerships we could look at between CBS, Héma-Québec and some of the fractionators.
Senator Seidman: Ms. Goulstone, you bear a real need for this product.
Ms. Goulstone: Absolutely. We wholeheartedly agree with the Health Canada report. I quote:
. . . it is appropriate for Canada at a minimum to be able to provide sufficient plasma to meet the needs of the one group who are truly life dependent on IG – those patients with primary immunodeficiency.
Which we aren’t, at this point. For our group, the Health Canada report and our patient base was extremely vital. We agree with it wholeheartedly.
As Mr. Page said, this is not a black-or-white issue; there are alternatives here.
Senator Ravalia: Thank you to all three of you for a very compelling presentation. As a recently retired physician who lived and worked in a community where we were heavily dependent on these products, rural Newfoundland, a large cohort of hemophiliacs and other conditions that you mentioned. As providers, the concern was always the red alert when the immunoglobulin supply was deficient.
To continue with Senator Seidman’s line of questioning, would you be able to elaborate on some of the possibilities of the partnerships that could potentially ensure Canada continues to have a robust supply and in doing so, highlighting some of the conditions for which the products are produced so that we get a better sense of the vulnerability that exists out there?
I think each of you can probably contribute.
Mr. Page: For CBS in Héma-Québec, I don’t think their expertise is in plasma collection centres; their expertise is in blood collection and the manufacturing of fresh components. They do a fantastic job. It is really the for-profit fractionators — Shire/Takeda, Grifols and CSL Behring. Those are the ones that fractionate Canadian plasma today. They are the ones with expertise in collection. I would imagine, and this is my own idea, that it has been explored in the past between the blood establishment CBS and some of the fractionators. I would like to see CBS say, “Let’s subcontract these people who know what the job is, who know how to put in place plasma collection centres.” And they will do it on behalf of our public establishments. Then that plasma will be fractionated by those companies and come back to serve Canadian patients.
Like others, we don’t want to see the Canadian plasma lost forever. We want to contribute to the world supply but we also want to be self-sufficient with our own supply. That’s the kind of public-private partnership I could imagine working very well in Canada.
Ms. Goulstone: You were saying you served rural Canada. I think that’s a huge group for us, too. We are very concerned about the rural population, especially in PI. It is a disease state where are undiagnosed at between 70 and 90 per cent in Canada. We have to look at Canada as having such a large rural patient population that is underserved. With immunoglobulin going up 10 per cent year over year on average, between 8 and 12 per cent per year, and if we are able to treat better and are able to diagnosis more — and we all know we have a GP crisis in Canada. If we are able to get those patients properly treated, our IG needs will only continue to increase.
We need to look at increasing the supply and our self-sufficiency. The point was made next to me; CBS has not proven to have the capacity to increase the supply but there are people who can. And there are companies who can. How can we look at a public-private partnership where we still retain control? We have Health Canada and Canadian Blood Services and Héma-Québec who maintain the oversight and the control. But yet we are still able to increase the supply, our self-sufficiency, retain that plasma in Canada and for the Canadian needs.
Mr. Penrod: I have to be careful because I’m a trade association guy so I can’t predict what my membership might do in terms of a commercial arrangement. What I can say is that Canadian Blood Services and Héma-Québec are both world-class organizations. David and Whitney both mentioned that several members of PPTA already have a high level of engagement with CBS and supplying the Canadian market. Our industry is deeply committed to making sure that the needs of these patients with critical and rare diseases are met. And, of course, I don’t want to speak on behalf of CBS either. I think this is all on your mind to ask Dr. Sher from Canadian Blood Services to see what he thinks, because he is in the best position to answer that.
Mr. Page: We do have a model in Quebec. And Quebec supported Green Cross to establish a fractionation plant, which I believe will open in 2020. It is a bit ironic. They will be bringing in 500,000 litres of plasma from the U.S. because Quebec prohibits payment for plasma donors. Quebec is not able to collect a large amount of plasma unless they change the law. But this is an example of partnership which could go a bit further. The Quebec plasma centres are struggling to collect the quantities of plasma on a non-compensated basis that they would like to have.
The Chair: Thank you very much.
[Translation]
Senator Mégie: I will ask my question in French. You said that Quebec is preparing to set up a plasma fractionation centre by 2020. Have they thought about producing immunoglobulins? How is Quebec preparing to bring in blood from the United States, do the fractionation, and send it back in order to prepare immunoglobulins?
Mr. Page: The plasma centre will produce immunoglobulins, Factor VIII, albumin and fibrinogen. It will not go back to the United States. The fractionation centre will produce them.
Senator Mégie: I know there is a public-private partnership, and that is very good. Who will be responsible for the quality control of the plasma coming from the United States? In Canada, I believe we have enough guidelines to manage it. However, how will we be able to handle the quality control of the plasma coming from the United States?
Mr. Page: The FDA in the United States and Health Canada are both responsible. Health Canada will inspect the centres and ensure that the plasma is produced according to the regulations.
Senator Mégie: As you know, detractors always talk about the quality of the blood in the place where a plant collects its blood. It is always done in disadvantaged areas. People come to give blood and then use the money to buy drugs. That’s why I talked to you about quality control, given the fact that people are paid. It’s because they need the cash.
Mr. Page: People have all kinds of reasons for giving blood or plasma. Money is one of those reasons. Everyone is subject to the same criteria. If you want to give blood, either in a plasma centre, at Héma-Québec, or at Canadian Blood Services, the criteria are the same. The clinics are inspected in the same way by the FDA as by Health Canada. There is no difference. People who want to sell their blood to buy drugs cannot give blood. They will be turned away.
[English]
Mr. Penrod: I have a quick follow up on what Mr. Page just said on the nature of plasma that’s collected in plasma centres in the United States. Every single one of those centres has to be licenced by the Food and Drug Administration at a very minimum. Plasma centres are frequently inspected by a number of regulatory agencies. Furthermore, it’s not just a one-time inspection. They are periodically inspected every couple of years. In addition, the voluntary industry standards program, the IQPP — International Quality Plasma Program — constructs independent third party audits of the centres. Those have added requirements on top of already stringent regulatory requirements regarding donor selection, suitability and safety.
The Chair: I’m sure there will be more questions on regulation because that is something many of us are worried about, I suppose.
Senator Poirier: Thank you all for being here and sharing the concerns that you have. It is greatly appreciated. I have a couple of questions. I’m from New Brunswick and in New Brunswick, as you know, paid plasma is allowed at this point and has actually been for a little while.
A concern we’re hearing from New Brunswickers a bit — or from people who are concerned — is that the people we’re attracting to the paid plasma right now are youth — the younger generation. They’re worried that instead of having the donors going to Canadian Blood Services on a voluntary basis, down the road, this generation will no longer be in the habit of going — will more or less going toward the paid services, where the use of blood or plasma is not guaranteed to be used in Canada.
That’s one of the bigger concerns we’re hearing. I’d like you to comment on those concerns.
Also, is there a guarantee that the paid plasma that’s collected in Canada will be used by Canadians? That’s one of the questions we’re hearing. The other one is: How much of the paid plasma that is collected in Canada now is used by Canadians?
Mr. Penrod: I’ll take the first shot. I know the owners and operators of Canadian Plasma Resources operating currently in New Brunswick will be a witness next week. I think the specific questions about donor demographics or things like that can be best addressed through them, along with the contract supplier.
The question of younger donors or donor demographics is something that we, quite frankly, in the industry that compensates donors struggles as well, because social norms and social demographics are changing. I know that a number of our member companies have done some in-depth studies as to how to attract people to donate. David alluded to this point earlier: It’s not just the compensation; they go there for an experience. You are not going to hold on for a donor very long if they’re mistreated. People will vote with their feet and go elsewhere.
The issue is more complex; it’s as complex as human behaviour itself. We have struggled in a lot of different areas to find younger donors, looking at ways of reaching them — the right medium and the right message. Picking up a phone and calling somebody at dinner doesn’t cut it with the youth today.
We’ve been constantly searching for new channels for doing that.
To the greater question of whether we think there’s an issue with losing younger donors, what we have seen from our data is that we’ve recognized two fairly distinct donor populations. Our donors do tend to be young. They also tend to be college students. What we think — and this is anecdotal at this point; it’s something we’re looking at — is that as somebody gets older, they move on in life. They’re no longer in college. They have different demands on their time. We think that, eventually, plasma donors become blood donors over time. That’s something we have to watch. This is just anecdotal observation at this point, but we would be curious to find that out as well.
I’d also like to note that, currently, Georgetown University is undertaking a study comparing the plasma donor population to whole-blood donor population. It’s one of the largest studies ever undertaken to look at this. It’s taking place in six U.S. cities. It will be concluded soon. There’s a number of data points that have to be addressed, and there are a lot of questions that are being asked and answered. At this point in time with the research that’s been done on some pretty saturated areas — cities that have a lot of plasma and blood donors — there doesn’t seem to be much overlap. They seem to be independent populations and don’t have an effect on each other. But we’ll, of course, review these findings carefully once they’re fully released and fleshed out.
Mr. Page: Can I comment on your question about Canadian plasma going to Canadian patients? I think we need more Canadian plasma for IG patients. But if we take ProMetic Plasma Resources in Winnipeg, which collects Canadian plasma, their products go around the world. We don’t keep all that. They make too much for the Canadian patients. This is a global industry. Companies that make plasma will sell their products around the world.
Ms. Goulstone: In regard to the fear that if there’s a centre that opens up, we’ve been hearing that, too — that if there’s a centre that opens up that’s compensating donors that’s near a Canadian Blood Services centre. We need to say that NRBDO, CIPO and CHS — we work closely with Canadian Blood Services. We’re all stakeholders. We’re all on their national liaison committee. We work with them in partnership and have for the last 20 years. We hear it from everybody, and we constantly will work with them.
The data about taking donors away is anecdotal at this point. If they do, if Héma-Québec — it’s not really an issue there — but if Canadian Blood Services or Héma-Québec do want to do a study to find out if there is an impact on their donor base, all patient groups would be open to undertaking that study. I think that’s something that’s needed to see if there is a real consequence here.
Senator Dasko: Thank you for your statements today. I’m very impressed with the statements of all three of you. They’re powerful arguments. In seven minutes, you’ve all made a case strongly. I’m impressed to hear your arguments.
I’m interested in the federal-provincial aspect of this. You’ve told us that three provinces prohibit the payment for donors. Those are Quebec — who else?
Ms. Goulstone: Ontario, British Columbia and Alberta.
Senator Dasko: Right. You have some big provinces now prohibiting it.
I assume that if this bill passed, it wouldn’t be possible across the country.
Mr. Page: Except by CBS.
Ms. Goulstone: In exceptional circumstances.
Senator Dasko: I see. Right. If this bill came into force, could a province decide to go against what this bill said and allow it for their province? I hate to use the word, but who trumps whom in issues of jurisdiction around here?
Ms. Goulstone: I’m not an expert on constitutional law. I wouldn’t know. David?
Mr. Page: Neither am I. I would guess that a company that has been established for 30 years, like Emergent Biosolutions — now ProMetic Plasma Resources — in Winnipeg, which has been doing a fantastic job, would not be happy if they were suddenly told they couldn’t do business.
Senator Dasko: I don’t think their patients would be, either.
The Chair: Health Canada probably will be able to answer that question when we host them.
Senator Dasko: When these bills were being enacted in the four provinces, did any of you make representations there? And were these bills recent?
Ms. Goulstone: Yes. The Quebec bill was the first.
Mr. Page: The Quebec bill was passed when they revised their civil code in the 1990s. Plasma was not the object. I think they prohibited sale of body parts and organs, and never realized that plasma would be an issue. Quebec was a bit different.
Ms. Goulstone: The Ontario bill was four years ago. It was specifically in reaction to the Canadian Plasma Resources. It was a very reactionary bill to the Canadian Plasma Resources.
Mr. Page: The other two were in the last two years.
Ms. Goulstone: Yes, the B.C. and Alberta bills were 2017.
Senator Dasko: You’re not sure exactly how it would work if one level says one thing and another level says something else.
Mr. Page: We know that Health Canada has said that this decision is not in the federal jurisdiction; it’s a provincial-territorial jurisdiction.
Senator Dasko: Okay. Thank you.
Senator Munson: Can I have a supplementary? Just to follow your questioning. Does the federal government, in your view, have the authority to prohibit compensation to blood donors?
Mr. Page: I’m not a lawyer. Health Canada has told everybody that they think they do not have jurisdiction.
Senator Omidvar: I have a number of questions. I think all of you can answer them. I don’t need three answers, in the interest of time. You were very compelling, as my colleagues have pointed out. I also must point out that our witnesses before the break were also very compelling. It’s our job to try to sort it all out.
I want to start with a basic fact that I do not know. How much does an individual get paid to sell plasma if, let’s say, I’m selling a litre? I don’t even know. Half a litre. How much would you get paid?
Ms. Goulstone: Which country are we talking about?
Senator Omidvar: Let’s talk about Canada. Let’s talk about New Brunswick, because there you can donate.
Ms. Goulstone: You get compensated with a gift card, with roughly $30, I believe.
Senator Omidvar: Is there a huge variation in those provinces where it is possible?
Ms. Goulstone: I’m not certain, because we’re not affiliated or have anything to do with this company. From what I’ve been told, I believe it’s $30 per donation on a gift card.
Senator Omidvar: In those jurisdictions, the three provinces — British Columbia, Alberta and Ontario — which have implemented a ban on the sale of plasma, have you seen a rise in blood donors or a drop? Do we have this evidence?
Ms. Goulstone: In the collection of red blood cells, Canada is 100 per cent self-sufficient. The demand for red blood cells is going down every year due to efficiencies that we have in medicine. We don’t need as much red cells every year so we’re 100 per cent self-sufficient.
Senator Omidvar: I’m trying to understand the correlation between selling and simply giving. There’s a strong case being made before us that one should just extend the ban on sales of blood throughout the system. I’m not quite sure; perhaps we can go outside Canada. In those jurisdictions where it is sold or prohibited, is there a correlation in the numbers of people who donate blood?
Ms. Goulstone: Even in countries where it’s illegal to sell your plasma and blood, you can still be compensated for your time and travel costs. In Europe, 27 EU member states will reimburse up to 40 euro, depending on the country. Even in France, where they’ve outlawed the sale of blood and plasma, you can still compensate for time off work and your travel costs to the clinic to donate blood and plasma.
Mr. Page: That could be more than is being paid here in Canada or in the U.S. with a cash card.
Senator Omidvar: That answer was very helpful. You said “kill the bill.” I’ve sat on this committee for quite a long time, and we always hear “amend the bill.” I’ve never heard “kill the bill.” This is pretty strong language. Would you consider an amendment to the bill that would increase the supply of plasma through following practices, such as the ones you have pointed out in the EU, where it is not the price of plasma; it’s the travel? Can you help us a little somewhere here?
Mr. Page: I’m not sure you can put that in a bill, but I think we should be open to looking at incentives for donating plasma. As Whitney said, what we try to do with plasma collection is for people to want to come every week, because you want regular, trustworthy donors. They come every week and you won’t get people doing that without compensation, at least for their time and travel.
Senator Omidvar: I have a final question and it gets us back to Canada. British Columbia, Alberta and Ontario have all implemented a ban on blood donor compensation. Quebec has a broad prohibition. We’re looking at 86 per cent of Canada’s population that us already banned from selling. This bill will impact what, 14 per cent?
Mr. Page: Yes, and no.
Senator Omidvar: Help me out here.
Mr. Page: As I said, perhaps there’s a middle road. If CBS and Héma-Québec, because in your bill they’re exempted, are the ones who pay and they subcontract really competent collectors, fractionators to set up the collection centres, perhaps you could get around it because Ontario, B.C. and Alberta all exempt CBS from their bill.
Senator Omidvar: Am I hearing you say there could be an amendment to the bill that would meet that?
Mr. Page: I think the problem with the bill is that its intent is not to compensate, and that’s not the answer.
Senator Omidvar: The principle of the bill. Thank you.
Mr. Penrod: I just want to add a couple of points there. With the example of France, that country has a state-owned fractionator called LFB. They get plasma from the national blood donor organization in France. However, they also opened and have acquired plasma donation centres in Austria and the United States, which compensate donors. The domestic, “non-compensated donor” in France wasn’t sufficient to meet the needs of France without coming to the U.S. or Austria.
Senator Forest-Niesing: I’ll start with the shortest question and possibly the shortest answer. I’m interested in hearing whether you are aware of any research that would reveal what the other motivations of plasma donors are? I’ve heard each of you makes reference to the fact that monetary compensation isn’t the only motivation for a plasma donor. What do you know of the other factors?
Mr. Penrod: I can name a few things. Marketing research has been done by our member companies. Certainly compensation is an important component of it. In a large part, that’s due to a lot of the factors that David mentioned earlier, where you want to make sure that people are donating regularly. By having that and by eliminating a barrier to donation in that way, it’s extremely helpful.
There are a number of other factors that donors experience. A lot of plasma centres have been around for a very long time. A lot of donors have been donating for a very long time. A lot of centres have a social connection inside the centre among donors. That’s certainly one.
One should never overlook the fact that a well-educated donor coming into a centre comes into contact with information quite soon that shows they’re helping people. This notion that it has to be one or the other, that it has to be black or white, that people can’t have multiple motivations for something is just doing a disservice to human nature.
There are a number of reasons why people donate, and that’s fairly marketing oriented as to how plasma centres attract people to donate. But those are three big ones.
Senator Forest-Niesing: Thank you. Do we know how important it ranks, the compensation element, what the level of importance is? Is it the first and most influential motivator?
Mr. Penrod: I think the compensation aspect is a very important one in order to attain the frequency of donations that we need. I suspect there are many donors for whom compensation is unimportant, somewhat important, highly important or extremely important. It depends on where they are in life. It depends on a number of different factors.
It also, quite frankly, depends on the area in which the centre is located, and a host of other factors. Overall, I would say compensation is highly important, but it’s not necessarily the thing that keeps somebody going time and time again.
It’s important to have that, but once somebody gets aware of it and what the donation is used for, there’s a host of things that help people want to come back.
Senator Forest-Niesing: There are plasma collection centres in Canada — I understand one in Saskatoon, in Winnipeg and in New Brunswick. Do we have hard evidence about whether compensation in exchange for plasma donation in those provinces has or has not impacted the voluntary donation of whole blood?
Ms. Goulstone: There’s no data.
Mr. Page: No official study, no scientific study.
Mr. Penrod: Next week, whenever you have those individuals, those would be good questions. I know Mr. Bees in Winnipeg has been operating that plasma collection centre for a very long time, for decades. He is the foremost authority and the dynamics associated with donation in that area.
Mr. Page: We have to remember that only 3 per cent of eligible Canadians give blood to CBS and Héma-Québec. There’s 97 per cent of people out there we can call on.
Ms. Goulstone: I think that’s a great statement.
Senator Forest-Niesing: That puts it into perspective, Mr. Page. Thank you.
Senator M. Deacon: I was interested in what you were talking about in that comparison of donors in relationship or correlation between whole plasma donors and blood donors, which I think we will hold off.
The other piece you started to talk about earlier, Mr. Penrod, I wasn’t sure if anyone else wanted to add. I was trying to get a sense of the domestic and international numbers. You’ve given us a 3 per cent example, but those numbers of whole plasma, blood donors and/or both. The final thing that Senator Omidvar talked about was amendments. You’ve been really succinct on the amendment topic. I feel like unless there’s anything you want to add in those areas, I feel like my questions have been responded to.
Ms. Goulstone: It’s a really big undertaking. The needs of plasma right now in Canada and where we’re at and how scary it is and how fast we’re dropping and how many donors we actually need. Canada currently has a donor base for whole blood, and we’re great. We’re 100 per cent self-sufficient. Every year we still have to get 100,000 new donors for new blood, for the turnover, for the people who drop out, for the people who die. It’s a huge recruitment effort.
For the plasma plan to succeed, we need between 200,000 to 600,000 new plasma donors on top of that 100,000. Then there will be plasma donors who drop out. For plasma you need donors who donate on a regular, ongoing basis, not the blood donors who come once every three months to once every year. You need donors who donate once a week to once every two weeks. They have to be ongoing. That’s a lot of donors to get in a very short period of time to meet our plasma sufficiency plans in the next five to eight years. If only 3 per cent of our population donate blood, how much of our population is going to donate plasma?
Mr. Page: Just to show where we’ve gone, CBS and Héma-Québec have been talking about this for 10 or 15 years. They’ve realized it’s an issue. Ten years ago they were 30 per cent self-sufficient for IG, both of them. Now they’re 14, 15, 17 per cent. It’s a losing battle. As the need has gone up, they haven’t followed. I wish them luck. I’m not confident.
Senator M. Deacon: You said that this is a great need and you described the frequency — weekly, biweekly, this has to be a commitment and what we’re looking for — I think we know what you don’t wish to see. Do you have other thoughts today on how we can make that appealing and get those numbers up higher beyond what we’ve heard?
Ms. Goulstone: Yes. I think that a public-private partnership with CBS, Health Canada and Héma-Québec at the helm overviewing, but I don’t see it happening without compensation or incentive. We need to motivate Canadians and realize this is a crisis. This is an urgent need. People don’t even know what plasma is. People don’t realize that 55 per cent of our blood is made up of plasma.
Right now the only time people hear plasma is this negative paid plasma, money for blood, and that’s it. People don’t see the face of patients. I get told all the time that you’re a patient who uses plasma; you look fine. They don’t understand there are people dying without plasma.
Senator M. Deacon: That education piece is a big part of it, even at our own tables.
Mr. Penrod: I want to put more context on an answer for you, senator. For 2017 we had 43 million source plasma donations. That was the highest year that we had on record. Donors donate an average of 17 to 20 times per year. You can do the math as to how many donors that equates to.
The one thing I would add to the European model, back to the question about are there amendments that could work would, in Europe, even in countries with strong compensation schemes, such as Germany and Austria, donations have been flat for a number of years. They have been unable to get donors.
The other ideas about tax rebates or things of that nature have been met with, I would say, mixed success, at best. As I said at the outset, we have trouble oftentimes attracting donors. There’s no magic pill; it just takes a lot of different things. Our companies have a lot of expertise in attracting and managing donors. It can be difficult. There’s no question about it.
Senator Tannas: I wanted to go back to these numbers. You just said 43 million donations. Was that in the United States or in North America?
Mr. Penrod: That was the United States. Well, that probably included the Winnipeg centre too.
Senator Tannas: I was trying to understand. That’s roughly 2 million people making donations; right?
Mr. Penrod: Probably.
Senator Tannas: About 1 million people. If Canada was on par, we would have 210,000 donors because we’re one tenth the size, and we have 100,000 donors at the moment. Is that right?
Ms. Goulstone: No. Currently for plasma we collected, I think it was, 170,000 litres last year; so that would have been nothing.
Mr. Page: You have to be careful here. You have to separate whole blood collection to plasma collection. Our plasma collection is next to nothing.
Senator Tannas: How many units a week?
Mr. Page: Those units don’t come from plasma collection. Those units come from recovered plasma from whole blood collection. You separate the blood, and if you don’t need the plasma surplus, you send it for fractionation. That’s a different process. In terms of plasma collection, next to zero.
Ms. Goulstone: I think it was 120,000 to 170,000 litres.
Mr. Page: That’s recovered plasma, not source plasma.
Ms. Goulstone: Last year we met 14 per cent of our plasma needs.
Senator Tannas: Much of your plasma would be coming from people who get phlebotomies who can only donate every three months and that sort of thing; right?
Mr. Page: Yes.
Senator Tannas: But you have to give blood more often. I’m one of those guys; Senator Wells is one of those guys. I can’t remember the name of it, but too much iron in our blood.
Mr. Page: We don’t do as much transfusion of plasma anymore. Most of the plasma that comes from whole blood donations gets rerouted into fractionation. That’s the 170,000 or 200,000 litres. That’s not going to change because you’re not going to get more red blood cells. There’s basically no source plasma collected.
Senator Tannas: How many people in Canada need this product on a regular basis?
Ms. Goulstone: There are various numbers of patients, depending. There’s a certain hemophilia group it can be used for. There are the primary immunodeficiency patients, which is about 30,000 patients, and then there are Alpha-1 patients — I don’t know how big that group is in Canada — hereditary angioedema, which is 700, 800 patients, and then there are Guillain-Barre syndrome and CIDP patients, ITP patients.
Mr. Page: There are 45 products.
Senator Tannas: 75,000 patients?
Ms. Goulstone: Albumin for burn victims. Maybe 150,000.
Senator Tannas: Everyone has uncles, aunts, cousins, brothers, sisters.
Ms. Goulstone: All rare diseases.
Senator Tannas: What’s the issue again as to why we don’t have voluntary plasma donation? Nobody goes?
Ms. Goulstone: Canadian Blood Services put a plan in front of the government two years ago that hasn’t been approved yet.
Senator Tannas: Other than private, there’s no public?
Ms. Goulstone: There’s no way to donate plasma in Canada.
Mr. Page: Except in Quebec. They’ve got four or five plasma-vie centres. They are collecting a small amount of source plasma. Winnipeg, too.
Mr. Penrod: At the risk of getting too visceral, I want to put you in a position of what it’s like to donate plasma. I’m sure some of you around the table have donated blood from time to time. Whenever you’re donating plasma, it takes about two hours or so. That doesn’t count the screening time leading up to actually being in the bed, hooked up to a machine with a large needle, and then asking this person to go through this experience at least once a week, 20 times in a year. It is a commitment that cannot be overstated.
The Chair: Unless I’m mistaken, the needle is bigger.
Mr. Penrod: Yes, it is.
The Chair: For a lot of us, it’s challenging to see the difference in how it’s needed, so thank you for clarifying that.
We do have time for a second round.
I would like to ask a question. Many of you have answered part of it from different angles, but I want to have it on the record for this committee and colleagues. In your opinion, when it comes to compensated plasma donation — and I’m thinking that here in the Senate, we have a responsibility to protect the most vulnerable. In this case, I want to make sure the donors are safe and protected, and that it goes under the same regulation, compliance and monitoring as voluntary donation.
I have an example; I’m not even sure where it’s from. It’s of maybe an individual who could, somehow — and because they do want compensation — donate more than once a week. I want to make sure this does not happen in Canada or that donors are leaving a clinic without having the advice to rehydrate properly.
Can you briefly answer that?
Mr. Penrod: I’ll do my best, briefly, but it is a fairly long and involved process. If I misstep, please tell me to stop, back up and explain something.
The process that potential donors go through for screening assessment and suitability is an extremely exhaustive one. The first time someone comes, they are subject to a screening questionnaire, screening tests for protein, hematocrit, pulse, blood pressure. They go through a limited physical examination to make sure they are suitable for donation.
The entire process is set up in such a way so that donors are closely observed.
In answer to your question, Madam Chair, about over- or cross-donation, we have a system. It’s part of our voluntary industry standards. It’s called the cross-donation check system. It is a near-real-time system that is shared by our industry to make sure that donors do not donate in excess of what’s allowable. I could not possibly go into the details of how complicated it was to get the algorithms right with the computers, but it works.
We also have a system called the national donor deferral registry. This ensures that a donor who has tested reactive for HIV, HCV or HBV is deferred throughout the entire system. If I am HCV-positive — and this happens to me whenever I’m a plasma donor and attempt to donate plasma — I get entered into the database. I cannot donate again at any plasma centre in the country, because it’s a shared database throughout the industry.
We have a number of layers of safety that help ensure the quality of plasma and that also help ensure the safety and health of the donor.
We also have an ongoing new scientific and medical investigation monitoring system we are calling “plasma vigilance.” We are undertaking a number of studies to monitor the long-term health of donors. As we have all learned so far in our discussion here, donation is really important. The last thing the industry wants to do is harm donors. We need them to come back in order to treat patients.
Senator Seidman: Clearly, you are answering very serious questions posed by members of the committee.
I want to look at the bill itself. You are talking about public-private partnerships. I have a couple of questions. Is legislation the only way to do what you are proposing, or is that something that can happen with the existing system, without a piece of legislation?
If I look at the preamble to this bill, which is a very short bill — it’s an amendment to section 4. The preamble says:
Whereas in Canada human blood is a public resource;
And whereas the sustainability of the blood system in Canada must be protected;
Then they go on to make this amendment that no other establish other than the Canadian Blood Services can collect allogeneic blood for remuneration, unless the blood collected is of a rare phenotype.
It’s a sustainability issue. I think some of my colleagues already tried to get at that and the whole issue of whether paid blood will impact the sustainability of our blood system.
I’d like to know if you think that preamble about the sustainability of the blood system in Canada must be protected. Does the amendment — in other words, does the bill — actually achieve that stated objective in the preamble? I don’t know who can help me with that.
Mr. Page: It does the opposite: It creates barriers.
Senator Seidman: Okay. I think that’s what I have been hearing from you. But that’s in the preamble; that’s the stated objective of the bill. You are saying it does the opposite — that it creates barriers?
Ms. Goulstone: I agree with David. And again, it leaves out Héma-Québec. I know that was stated but it needs to be restated.
It does not look at increasing supply or increasing self-sufficiency, which would look at sustainability in Canada.
Senator Seidman: You are saying there are other ways to protect and establish that sustainability.
Ms. Goulstone: And access to supply.
Senator Seidman: And access to supply. You have talked about some of those. In response to my question, you proposed you would discuss it a little later. In response to Senator Ravalia’s very pointed question about those other ways we can have a sustainable blood system. Is your primary proposal a public-private partnership?
Mr. Page: That’s one idea. There may be other ideas. It may be the American system, where you have a completely independent private collection system. You have the Green Cross model with Quebec, where it’s a bit hypocritical. They funded Green Cross to set up there. They have got contracts; they will buy the key products from Green Cross, and Green Cross will sell the rest of its products on the international market. It’s hypocritical in that they wanted to attract a company to fractionate in Quebec, pay them taxpayer money to do so, but also are maintaining their prohibition on compensation and allow them to pay American donors. It’s hypocritical to the Nth degree. That could be changed. But that’s a model.
If they relax the prohibition, they would have their collector, the fractionator and a contract to get the products.
But I don’t think legislation is the answer here.
Senator Seidman: Right. I’m getting that message. Thank you very much.
[Translation]
Senator Mégie: I have a question about a company called Emergent, in Winnipeg. You said that it is able to collect a good amount of plasma and sell it abroad. Did I understand correctly?
Mr. Page: No, that is not quite right. I think that it is quite a small company. It is not a major plasma collector. It makes very specialized products like WinRho, which is used to treat women who are RH negative. The company also makes hyperimmunity products that I believe are effective against terrorist or biological attacks. I don’t know how many donors it has. It has enough products to sell them internationally.
Senator Mégie: I thought it had enough donors to collect from. That’s why I was wondering why it doesn’t keep them for Canada.
Mr. Page: It sells products in Canada, but also elsewhere.
Senator Mégie: Okay, I misunderstood. Thank you.
[English]
Senator Omidvar: I believe there is a bias in Canadian law that speaks against the commercialization of any part of the human body. We have a ban on blood donations. You cannot sell. We have a ban on the sale of blood. We have a ban on the sale of human organs. This committee recently passed a bill, and it passed in the Senate as well, that would penalize Canadians from buying organs overseas. And this bias is reflected in our laws. So here is this bill and you’ve made excellent arguments that patients need safe products. We need to keep our supply up. Other countries are going this route of ensuring sustainability. I wonder if you can speak to the larger philosophical question of should we sell any part of a human body? I’m struggling with that.
Mr. Page: We sell our services, time and effort all the time.
Senator Omidvar: Yes. That’s work. I get that.
Ms. Goulstone: I don’t look at it as selling. In our patient population we’ve had these discussions for quite a number of years. As somebody who infuses weekly, I infuse a product that comes from compensated donors in the United States. A lot of people in our patient base have said they would much rather use a product that comes from compensated Canadians than a product that comes from compensated Americans. That’s one side of the argument. Another side of the argument is I wouldn’t look at it as necessarily selling blood or a blood product. That’s something, which I put in the statement, the European Commission made this distinction versus compensation and incentive where it’s reimbursing people for the two hours it takes donating their plasma on a regular basis. You can give blood in ten minutes. For regular blood donors that’s how long it takes. They’re in and they’re out. But every time, no matter how regular a plasma donor you are, it will take two hours. With the time it takes to get to the clinic and get back, that’s how long it’s going to take.
As far as compensating, there could be time off work or a tax break. There was a debate on the radio about textbooks for university students. You give some kind of incentive, who knows what it might be. I don’t think of that as the sale of a body part when you are saving someone’s life. Without this product, I would be dead and so would other patients.
When it comes to life-saving products and an incentive for compensation of someone’s time, I don’t think of it as selling blood for cash.
Mr. Page: Let’s look at it this way: You can pay people $25 or $30 for a renewable resource. Their plasma is renewable. We have just heard that. You say that’s not good, that’s unethical. If you want to be consistent you won’t use American plasma either. The result is thousands will die. There is your choice really because that is the choice.
Mr. Penrod: The National Organ Transplant Act in the United States passed in 1984. It’s a similar statutory and regulatory system set up to stop sales, procurement, and trade of human organs. But there is a pretty critical distinction made within that setup to recognize the difference between something that is renewable and replenished by the human body versus a permanent change in physiology. As a result of the replaceability issue, there is a different ethical calculus associated with that.
Senator Omidvar: Thank you, Mr. Penrod; that’s very helpful.
I believe it was Dr. Page who said that in Canada currently, if I wanted to donate plasma I can’t actually do that. Is that right?
Mr. Page: CBS closed its plasmapheresis centres a few years ago because of the lowering need for plasma for transfusion. I don’t think they have any centres open now. You can come to Quebec. Quebec has plasmapheresis centres in four or five medium-sized cities in Quebec. That’s their effort to try to increase their supply.
Senator Omidvar: Is that all donated plasma?
Mr. Page: Non-compensated.
Senator Omidvar: What do they use that for?
Mr. Page: For fractionation. This is something that Dr. Sher from CBS is best able to address, but I would be surprised if they don’t have any capacity in blood centres because there is plateletpheresis and there are other pheresis mechanisms used in transfusion practice. They probably have some basic setup they can use. But the issue again — and David has said this a couple of times — is really one of scale, volume and frequency.
The Chair: Senator Omidvar, in relation to your first question, in the next few meetings we will have a bioethicist as a witness. We can go further with that good question.
Senator Kutcher: Thanks for your testimony. You have re-educated us on some fine distinctions — source plasma from other kinds of plasma; all those important components. I thank you for that.
If I understand correctly, you are saying your concerns about this bill is that the bill will impede the ability for Canada to create a life-dependent renewable resource. You have made the point that our supply of this resource is going down and the demand is going up. Now, I’m not an economist but that doesn’t sound good to me.
Senator Omidvar: Seller’s market.
Senator Kutcher: Yes, exactly, it’s a seller’s market. We do not have the readily available infrastructure to ramp up production when we need it. The big challenge is not the challenge we have today but the potential challenge we will have tomorrow when the supply continues to go down, demand continues to go up, and we will not be able to address a life-dependent resource. Do I understand you correctly?
Mr. Page: I couldn’t have said it better. Three years ago I might not have said this, but stopping products at the border — tariffs?
Senator Kutcher: I didn’t even want to go there. Senator Omidvar already did.
Ms. Goulstone: Three years ago, Canadian Blood Services was supplying about 17 per cent of our own demands. It’s now at 14 per cent. The current projections are at 10 per cent in 2021. Demand is continuing to rise at about 10 per cent. It’s about 8 per cent to 12 per cent per year.
Senator Kutcher: I’d like to have your opinion on one of the arguments that we heard coming from the senator from New Brunswick, which I have heard as well. If young people are paid, compensated, incentivized to donate, when they become adults, they will stop doing this. I find that a very spurious and fascinating argument because most of the things we do for young people, we reward them for doing things that we no longer reward them for in adulthood because they grow up.
I’m interested to hear what responses you had to the components of those arguments.
Mr. Page: I think getting young people accustomed to donating, no matter what, is only going to be good in the long run. When they are older and richer, they probably won’t want to go and donate plasma for $30 once a week. But they may be interested, because they realize they help people, to go and give blood three or four times a year.
Senator Kutcher: The incentive may change but the behaviour will continue. Thank you for that.
Senator Tannas: I’m curious, did I hear a litre of blood or about half of it, 50 per cent, would be plasma? You can take whole blood and turn it into plasma, right?
Mr. Penrod: The process is one called plasmapheresis. The maximum donation size for whole blood is 250 millilitres, I think —
Mr. Page: I think it is 500 ml of whole blood and you take off 250 ml of plasma. That’s what goes to fractionation.
Senator Tannas: We have just established that there has got to be 150,000 sympathetic donors for plasma. If you have 75,000 people who need it, they only need one sympathetic person each to have 75,000, two for 150,000. Ms. Goulstone, you mentioned that you have heard people say, “If only I could donate plasma,” et cetera.
Would it make sense and would it be valuable to tap that by being able to walk into a blood donor clinic and say, “I’d like my blood to go for plasma,” Would that be helpful?
Ms. Goulstone: It would be great. We have partnered with Canadian Blood Services on different occasions. They come to our patient education days. We have worked with them on Giving Tuesday. We went out and volunteered in their clinic and handed out our educational material, raised awareness. Educating within our own disease state about donating blood and plasma has its issues because most of our diseases are hereditary and genetic. Within your own group, those people cannot donate blood or plasma.
I think we need to work together as a community to engage those people and try to encourage them to donate blood and plasma more. As CBS ramps up their plasma education, you have probably seen their rebranding that it isn’t just blood, it’s plasma, organs and tissues. We are really happy about that. As they ramp up their plasma collection, we will work with them as much as we can, as well as the other groups who use plasma, to do what we can to try and get them towards their goal.
Mr. Penrod: I wanted to underscore the types of numbers that we are talking about in order to treat these rare diseases. It’s not just one to one. For plasmapheresis, you need several hundred donors for each patient; 1,200 for hemophilia; 120 for PID. Other conditions in between those vary from 500 to 800. That’s with the volume that is collected at the plasmapheresis source plasma level, which is around 700 to 800 ml, not 250. If you are talking about donations strictly from whole blood, you need four times as many as you would for plasma.
Mr. Page: And we don’t need more whole blood. Then you would be stuck with the red cells.
The Chair: Thank you for this precision.
Senator Seidman: I have one a quick question. Each of you represent an association, an organization, the Network of Rare Blood Disorder Organizations, Canadian Immunodeficiencies Patient Organization and you, Mr. Penrod, from the Plasma Protein Therapeutics Association.
When one thinks of developing a piece of legislation, in the process of doing that, one consults in the community various associations. Were you consulted by the sponsor of this bill?
Mr. Page: No.
Senator Seidman: No patient groups were consulted. Thank you. I appreciate that.
Senator Omidvar: I’m going to stick with ethics. This is a question for you Mr. Page.
You sent me a letter, your organization. I imagine everybody else got the same letter. You made a statement. It’s complicated for me to deconstruct, so I’m going to read:
Plasma is used by for-profit pharmaceutical companies to create products which they, in turn, sell. The manufacture and sale of plasma products is almost entirely a private for-profit operation with plasma being the main raw ingredient. To say that the compensated collection of this ingredient puts our public health care system in peril or as Senator Wallin has suggested, could lead to an issue of national security, is a stretch at best. One could argue in this scenario that not compensating for plasma is in itself unethical.
Could you take that apart a little. It would be unethical not to compensate?
Mr. Page: There is profit being made all along the way. There is profit being made by the collection company, by the fractionator who sells that back to the Canadian governments, provincial and territorial government, at a profit. Why isn’t the donor compensated? Why is he giving away his admittedly renewable resource, for free? Seems to me —
Senator Omidvar: It’s part of the supply chain.
Mr. Page: One good thing in Canada is that the patient gets the products for free. This is another reason why this is not affecting our public health system. Blood products are supplied by Canadian Blood Services and Héma-Québec to all patients completely free of charge.
Senator Omidvar: But the taxpayer pays.
Mr. Page: Taxpayer pays, of course. This is different from many drugs sold in Canada where you go through your public or private insurance and you pay a co-pay. Thankfully, even though it’s a very corporate for-profit system with multinational pharmaceutical companies involved, the patients are getting these products for free. That’s really important.
Senator Omidvar: Thank you.
The Chair: I see no more questions. I want to thank you very much. I think my colleagues will support me in saying that you have been very valuable to our study of this complex but very important bill. Thank you so much for this.
Tomorrow we are continuing with Bill S-252. We will have with us the Canadian Doctors for Medicare, Canadian Federation of Nurses Unions and Canadian Union of Public Employees.
Before I let you go, colleagues, I would like to ask you to remain with me and secure agreement to proceed for a brief in camera meeting to discuss some other committee business. Is it agreed?
Hon. Senators: Agreed.
The Chair: We will suspend for a few minutes and go in camera.
(The committee continued in camera.)