THE STANDING SENATE COMMITTEE ON SOCIAL AFFAIRS, SCIENCE AND TECHNOLOGY
EVIDENCE
OTTAWA, Wednesday, February 27, 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 4:15 p.m. to study this bill.
Senator Chantal Petitclerc (Chair) in the chair.
[Translation]
The Chair: Good afternoon, everyone.
[English]
Welcome to the Standing Senate Committee on Social Affairs, Science and Technology.
[Translation]
My name is Chantal Petitclerc, and I am a senator from Quebec. It’s a pleasure to be here today and to chair this meeting.
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Before we give the floor to our witnesses — and we thank you for being with us — I would like my colleagues to please introduce themselves.
Senator Seidman: Judith Seidman from Montreal, and deputy chair of the committee.
Senator Eaton: Senator Eaton from Toronto, Ontario.
Senator Ravalia: Mohamed Ravalia from Newfoundland and Labrador.
Senator Oh: Victor Oh from Ontario.
Senator M. Deacon: Marty Deacon from Ontario.
[Translation]
Senator Forest-Niesing: Good afternoon and welcome. Josée Forest-Niesing from Ontario.
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Senator Moodie: Rosemary Moodie from Ontario.
Senator Munson: Senator Munson from Ontario.
[Translation]
The Chair: Today, we are continuing our study of Bill S-252, Voluntary Blood Donations (An Act to amend the Blood Regulations).
[English]
To begin our meeting, I would like our witnesses to please introduce yourselves and the organizations that you belong to, and after that we will welcome your opening statements. I want to remind you that you have seven minutes for your opening statement and we will follow with questions.
Barzin Bahardoust, Chief Executive Officer, Canadian Plasma Resources: Barzin Bahardoust, Chief Executive Officer, Canadian Plasma Resources.
William Bees, Vice-President, Plasma Technologies, Prometic Plasma Resources: William Bees, Vice-President, Plasma Technologies, Prometic Plasma Resources, a subsidiary of Prometic in Laval. We run a plasma centre in Winnipeg, which I’ll talk about today.
The Chair: Thank you very much. We will begin with you, Mr. Bahardoust.
Mr. Bahardoust: Thank you, Madam Chair and members of the committee, for the invitation to appear today. As you know, Canadian Plasma Resources is the target of this bill and, as Senator Wallin said to you in her testimony, her objective is to shut us down. So we welcome the opportunity to explain what we do and the patients we serve, and to correct the numerous untruths that have been stated about plasma collection in Canada and about our company.
We are licensed by Health Canada to collect plasma from donors for the sole purpose of manufacturing life-saving medications. These are for patients who suffer from immune deficiencies, cancer, HIV/AIDS, burns and bleeding disorders.
Starting in 2019, we also collect rare specialty plasma which is used to prevent the most common infection from expectant mothers to their babies, known as Cytomegalovirus, or CMV infection. This is a severe infection that can lead to neurological abnormalities, deafness and even death.
We operate two plasma collection facilities in Saskatoon and Moncton, where we employed 75 people last year, and we compensate our donors for their time and transportation costs.
One hundred per cent of the finished products used by patients in Canada are supplied by foreign for-profit corporations. As you have heard, approximately 15 per cent of the plasma needed to manufacture these drugs comes from volunteers in Canada. The rest comes from paid American donors.
Demand is growing every year. Last year alone, CBS and Héma-Québec spent over a billion dollars purchasing these products.
I would like to just take a moment on why companies find it necessary to compensate donors. Plasma donation rates in Canada are much lower than whole blood donation because donating plasma takes as much as four times longer, is a more complicated process, and requires qualified donors to be repeat donors. In some cases, it can take 1,200 plasma donations per year to manufacture the treatments for just one patient.
The significant time commitment required is a major deterrent to recruiting new volunteer donors and the costs associated with finding those volunteer donors are enormous. Health Canada’s expert panel report noted that the cost of collecting large volumes of source plasma using volunteer donors is two to four times more expensive than the commercial plasma collection model.
This is the real reason Canada and so many other countries rely on paid donors. It is why no country in the world meets the needs of their patients with a wholly volunteer model. It is the reason Canadian Blood Services closed its last dedicated plasma collection centre in 2012.
This committee has heard that CBS is planning to restart its source plasma collection efforts by opening 40 new sites over the next seven years. This will come at a significant new cost. CBS is asking the provinces and territories for $855 million to construct these centres, as well as an additional $250 million per year in ongoing operational costs.
Their goal is to reach 50 per cent self-sufficiency. Even if CBS is successful, Canada will still rely on the paid American donor for the other 50 per cent of our supply. So we will always rely on paid donors. What this bill does is ensure that the only paid donors in our blood system will be American ones.
Some have raised concerns that the presence of a paid plasma facility will have a negative impact on CBS’s ability to collect whole blood from volunteers. This is not supported by evidence.
While CBS has seen a decline in the 17-24 age segment in Saskatoon, which began before we opened our facility, that decline is less than the decline in the same age group in provinces where we do not operate. Furthermore, CBS’s most recent report indicates that they have experienced a 35.8 per cent increase in total voluntary whole blood donors in Saskatoon since we began operations there. This increase in donors was more than double the increase for the rest of the province. If anything, this suggests a crowding in of new volunteer blood donors for CBS.
These findings are consistent with Health Canada’s 2013 report that found that countries with paid plasma collection systems have much higher voluntary blood donation rates than Canada does.
Much has been made about the fact that our plasma is not benefitting Canadian patients. Our first choice is to supply Canadian patients. We are a Canadian company, and the need is greatest here. We have made numerous offers to both Canadian Blood Services and Héma-Québec to provide our source plasma at a fraction of what it costs them to collect source plasma themselves, but these offers have been rejected.
Our plasma saves the lives of thousands of patients in other countries, however, just as Canadian patients are dependent on foreign plasma for their treatments.
Finally, when it comes to safety, there is an established scientific consensus that paid plasma products are as safe as those which come from the volunteer donors. There has not been a single transmission of HIV or Hep C in over 25 years in patients using these products. In fact, with approximately 40,000 donations at our centres, we have not recorded a single confirmed case of a qualified donor with HIV, HBV or HCV. CBS, on the other hand, has recorded 13.3 confirmed positive donors per 100,000 and Héma-Québec has recorded 11.3 confirmed positive donors per 100,000. So to say that paid donors are less safe than volunteer donors is simply not true.
In closing, I would like to say that our intent is to supply a need in Canada’s health care system in exactly the same manner that foreign companies supply Canada’s health care system. This bill would prohibit that. A better name for it would be the foreign paid plasma corporation protection act. We respectfully request that this committee not approve the bill.
Mr. Bees: Thank you, Senator Petitclerc and Senate committee members, for the invitation to provide testimony regarding the impact of this bill on product availability for Canadian patients.
If the bill were passed today as written, it would essentially shut down the collection of specialty plasmas in Canada. This plasma is used to manufacture hyperimmune plasma medicines, which would impact on the availability of products like anti-D immune globulin, as well as the impact of development of specialty plasma medicines.
I’ll provide background today in this brief seven-minute introduction on the Winnipeg Plasma Collection Centre, past and present, and its contribution to plasma-derived medicines and lessons learned during my 38 years in the Canadian plasma industry.
During my career in the plasma collection fractionation industry, starting with the Winnipeg Rh Institute, I have worked in a variety of areas — quality, development and manufacturing operations — of blood and plasma products. I was fortunate enough to also serve on the Canadian National Blood Safety Council, an initiative established as a result of the Krever report. I am currently employed by Prometic Plasma Resources, as I stated earlier. I have given you a bit of background about Prometic, not wanting to give you a big ad on them, but it’s there for the reading.
Prometic Plasma Resources was established in 2015 when it purchased the Winnipeg Plasma Collection centre from Emergent BioSolutions, which was formerly Cangene Corporation. The plasma collection centre has a long-standing history in the supply of specialty human source plasmas used to manufacture the specialty plasma products.
The centre actually originated with Winnipeg Rh Institute, a non-profit, in 1969. It was founded by Dr. Jack Bowman, a pioneer in the Rh disease research, who led to the development of WinRho anti-D immune globulin. This product, licensed in 1980, saved over 4 million lives by preventing Rh disease. Throughout its history, the centre has paid donors for their program donation time. Many donors have contributed for over 20 years, contributing thousands of litres to the program. WinRho is not only a success in Canada, but in over 20 countries globally.
In the early days of the program, the plasma was shipped to Sweden, Spain and the United States for manufacture to other countries’ anti-D immune globulin.
There has been significant media attention around paid donation in Canada as being unsafe, with references to Justice Krever’s report and recommendations for corrective actions to address the 1980s blood scandal in Canada. HIV and Hep C viral transmissions in patients that were treated with unsafe blood and plasma products at the time was indeed a tragedy. Lessons from that time should never be forgotten. Much has been said previously about the safety of plasma from paid volunteers.
Just for the record, the Winnipeg plasma centre and its products, made from compensated plasma donor plasma, has never transmitted any blood-borne illness. This long track record is obviously attributed to not just the quality of the donors and strong selection programs to verify donor suitability, but ongoing improved plasma screening programs. Additionally, state-of-the-art plasma protein separation systems with highly evolved viral inactivation, as well as viral retention systems, greatly enhance product safety. The Krever Inquiry also reviewed the Winnipeg special collection centre and its practice of paying donors, and it deemed it to be both appropriate and safe.
Today the centre operates at the University of Manitoba Smartpark, an industrial park adjacent to the South Winnipeg campus. It has grown from its origin at the Winnipeg Canadian Red Cross facility and has embraced not only Health Canada compliance standards, but also U.S. FDA, European Medicines Agency authority standards and, additionally, PPTA voluntary standards, which are obviously a key part of staying abreast with safety issues.
When the plasma centre was relocated to the university campus and expanded, I had consulted with CBS at the time to ensure that we weren’t negatively impacting on their blood collections. Clearly the CBS does recruit blood donors out of the university campus.
The centre has operated on campus without crowding out CBS blood donors. I personally feel that the plasma centre raises awareness for the need for blood and blood protein products. Not many donors can become 20-year anti-D donors, but all are introduced to the impact that their blood/plasma can make a difference with patients and can save lives.
The plasma centre currently collects a variety of plasmas, and I provided an outline of those in the appendix. If anyone has questions, be sure to ask me and I’ll run through them.
With licensure of new products, more source plasma will always be required. While the centre has been a long-term supplier of plasma to support Canadian hyperimmunes distributed in Canada, like anti-D and Hepatitis B immune globulins, it is a global supplier with licences in Canada, the U.S. and, in the future, Europe. The reason for this is simple — rare diseases have fewer patient populations and require global efficiencies to be commercially viable.
The plasma centre is developing a plasma collection centre in Buffalo, New York. This will have twice the capacity of the Winnipeg centre. It will be fully automated and will become a future model for Prometic in its plasma collection operations.
Prometic does support the 50 per cent plasma supply strategy for CBS and it will continue to support its efforts toward achieving this goal. I have provided an example of how that can take place.
The bill has been written to protect CBS from private competition for plasma and plasma donors in Canada. I personally believe that industry can work in harmony with the blood operators with the ability to provide safe and secure plasma products for patients that are reliant on this unique source of biological products.
The Health Canada recent report on IVIG supply speaks to Canada stepping up to provide more plasma for patients that are reliant on these products. There is a role to play working together in synergy with the blood operators.
Wrapping up, very succinctly, this bill is unnecessary and should be killed.
The Chair: Thank you both for your presentation. If you have followed, this committee is very engaged in the bill and we do have many questions.
Senator Seidman: Thank you for your presentations. Mr. Bahardoust, you submitted a letter to all the members of the standing committee in which you refuted a lot of the testimony we have heard.
There is no doubt that the associations that represent patients have been very concerned about the impact of this legislation. I would like to ask you specifically about a point you made in your letter to us, and that has to do with your relationship with Canadian Blood Services.
You have said in your letter on page 2:
We have made numerous offers to both Canadian Blood Services and Héma-Québec to provide our source plasma at a fraction of what it costs them to collect source plasma themselves. These offers have been summarily rejected by the Canadian Blood Services. Canadian Blood Services did however purchase almost 50 thousand litres of US recovered plasma in 2016 which was almost double the volume from two years prior. This in addition to the $728 million worth of finished products it purchases during its tendering process each year. Should Canadian Blood Services or Héma-Québec decide to purchase Canadian plasma, we would make it available to them on a priority basis.
It’s really interesting because that’s been one of the biggest issues that has come up in opposition to allowing paid-for plasma in Canada. That is that, well, you know, we don’t do anything with our own derived plasma here. We export it all; so we don’t use Canadian plasma.
What is the issue with Canadian Blood Services? We haven’t had them in front of us yet — we fully intend to — but could you help me to understand why they won’t buy blood products from you?
Mr. Bahardoust: We got a response to our first offer to Canadian Blood Services that was given to them in 2016. They mention, in the response, that as stewards of the public system in Canada, they are currently developing their own strategy for expanding their plasma sufficiency through a multi-year expansion of their unpaid plasma collections. This is referring to that $855 million plan they have put forward to the funders, the provinces, that has not been funded.
They continued that, currently, as they are working through this expansion, they are not intending to further expand their plasma purchase commitment from other companies, besides the American suppliers that they are dealing with.
Senator Seidman: They won’t purchase Canadian —
Mr. Bahardoust: That was the response we got.
We have received secondhand information from some of the provinces that there are other potential reasons for that. One, for example, has been that they have told the provinces that if they engage with a private company, the company has no commitment to supply CBS after the contract expires, for example. But to us, that’s basically an excuse. We can have a longer-term contract. There could be other measures put in place to ensure we can continue a relationship with them. In any case, they have that kind of risk with any supplier, with American suppliers as well.
Senator Seidman: Yes, in fact, we heard that.
Mr. Bahardoust: That is the response we received.
Senator Seidman: In fact, we have heard that one of the reasons we shouldn’t pay donors here and have a purely voluntary system is because we need to develop that system in case of a crisis with the United States and not being able to get their plasma product supply.
Mr. Bahardoust: We also see an inconsistency there, because that plan, even if it works, is only going to take us to 50 per cent. Even if CBS thinks it’s a good idea to diversify and bring the rest of the 50 per cent from foreign sources, this is not sustainable globally. Because if every country wanted to collect 50 per cent of what they need, then where is the other 50 per cent coming from?
Senator Seidman: Exactly.
Mr. Bahardoust: To have a sustainable system, we need to have net self-sufficiency, not necessarily banning imports, but collect enough relative to what we use, basically, to have net self-sufficiency.
Senator Seidman: You did deal with the concerns around the safety of paid-for plasma. It has been clearly stated here that the safety issues are no longer really the issues, and that we have managed to have a very safe system and continue to do so.
In your letter to us, you also dealt with whether your clinics would undermine Canada’s voluntary system. That’s been another rationale that we have heard here. You gave the example of Saskatchewan in your letter to us.
Mr. Bahardoust: Yes.
Senator Seidman: Could you clarify that? You say that CBS experienced a 35.8 per cent increase in total voluntary whole-blood donors in Saskatoon over the same period that you were involved, and that they actually wrote that in their report, but we have not been told that.
You are telling us that your presence, as paying donors, has not had an impact on the supply of voluntary donations in Saskatchewan?
Mr. Bahardoust: The numbers that we have obtained from CBS through access to information suggests the opposite. So, for example, the year before we started, the increase in the number of new donors was 25.6 per cent in Saskatoon and 23.3 per cent in the rest of Saskatchewan; so they were comparable.
But during the course of the first year after we started, the number of new donors in Saskatoon increased by 35.8 per cent, but during the same period the rest of Saskatchewan experienced a 15.7 per cent increase. So the rate of increase in new donors in Saskatoon was double the rest of the province.
Now, Canadian Blood Services then mentioned their concern about the specific age group — they were fine with the total number of donors — and that’s the age group between 17 and 24 years old. There has been a decline in that category, but the largest decline happened the year before we started.
Since we started in Saskatoon, over a year there was a 2.5 per cent decrease in the number of donors in that age category, but there was also a 2.2 per cent decrease in the same age category in the rest of the province, so it was very comparable. Nationally, actually, there was a 4.4 decrease. So the rate of decrease in Saskatoon was lower than the national average.
Again, we don’t see any negative impact from our operations on the CBS voluntary model.
Senator Seidman: Okay. Thank you.
The Chair: Just for my own clarification, are we talking plasma donor to plasma donor, or plasma donor and whole blood donor?
Mr. Bahardoust: Whole blood donor.
The Chair: Okay, I just wanted to clarify.
Mr. Bahardoust: In Saskatoon and all of Saskatchewan, CBS has no plasma collection activity.
The Chair: That’s why.
Mr. Bahardoust: In Moncton, there is also no plasma collection activity. There are seven sites in all of Canada where CBS collects plasma.
The Chair: Thank you. I just wanted to make it clear for everybody watching.
Mr. Bees: As you are probably aware, the Health Canada report on IVIG supply talked about doing additional studies on crowding out.
You heard from Josh Penrod and PPTA recently. They have commissioned some studies on this. Georgetown University is about to put together a report which they can share with the committee for the crowding out or non-crowding out — call it crowding in — for Winnipeg, Saskatoon and Moncton, and they’re also doing it for some U.S. sites, once again comparing blood to plasma collection, showing it’s more of a synergistic effect in terms of boosting it, as opposed to it being a negative thing. This isn’t talking plasma to plasma. It’s quite a different beast.
Additionally, there was a presentation in Europe recently at a quality meeting and the Germans presented a crowding-out study in Bavaria that was, once again, very interesting. We can share that information with you.
Senator Ravalia: Thank you both for your presentations. In previous testimony, we’ve heard significant insinuations about the safety of the plasma that we potentially purchase from abroad, and in particular the U.S. For the record, I would appreciate some defined steps that you take in assuring and minimizing the risk of viral transmission, bacterial transmission and prions. Do you have a process of ongoing follow-up? Are you involved in any research projects with respect to those steps?
My second question is: What would the economic impacts of this bill be on Canadians who are currently involved and employed in the collection of this plasma? What would the impact be on a community like Winnipeg in terms of job losses?
Mr. Bees: Some things have changed significantly since the blood scandal in the 1980s. There is a much more regimented system for quality standards for viruses and prions. A best example of that would be when an emerging threat comes, like Zika. With Zika you have health agencies like Health Canada and the CDC in the U.S. that do surveillance and monitor what’s going on. We’re plugged into that as plasma collection centres.
We also have, through PPTA, an industry association, a committee of virologists that study this and do model systems. Everything’s based on modelling to verify what the impact of a potential outbreak of Zika, West Nile or what have you, and what goes on, and we take the appropriate steps.
Similar to the blood system, CBS did the appropriate thing in terms of their deferral category for Zika. I just got back from Asia. I’m a blood donor and I got deferred for three weeks for Zika, which I totally didn’t know about. The system works in terms of reducing threat, not that I had anything wrong with my health.
The bottom line is there is a working model in terms of looking at that. For prions and very much CJD — and we talked about chronic wasting disease the other day — we clearly do have surveillance operations going on within the global system.
For chronic wasting disease, for example, they look at the actual frequency of what’s hitting the herds and whether it’s jumping species. If it jumps into a species or jumps into humans, the first thing it would hit would be blood because blood is infused directly.
For plasma products there have been many studies done by any of the fractionators, including Prometic, to examine how we can remove prion-like substances in our processes. It’s well-established now in terms of the safety around that.
Notwithstanding that, if we had a look back where we find a donor actually came down with chronic wasting disease or something, we would basically be holding all of our product, investigating and probably having to destroy lots that had something just on a precautionary principle. It’s fairly straightforward.
The Chair: Mr. Bahardoust, did you want to comment on that?
Mr. Bahardoust: No, I think Bill has explained this process.
The Chair: I’m not sure if any of the witnesses have an answer on the economic impact that this bill could have.
Mr. Bees: Clearly, I don’t have stats in my head today, but I can certainly share with you what the economic impact in Winnipeg is. We have I think over 20 employees in our centre in Winnipeg, obviously gainfully and happily employed. We obviously provide our donors with honoraria in terms of their donations. I can provide stats in terms of what that represents from an economic impact.
We’re part of the university community. We are part of that in terms of paying bills and having a lease on campus. I can certainly share that information. I don’t have it today, but I can give it to you.
The Chair: Thank you. If you can send it to the clerk, we will share it.
Senator Oh: Thank you, witnesses. Is the plasma collected in Canada enough, or do you still import from the U.S.?
Mr. Bahardoust: Our company does not import any plasma, but as a country we do not collect enough plasma to meet the demand for plasma protein products. We collect enough plasma for direct transfusion, which is a small need. In terms of plasma protein products, we collect approximately 15 per cent of the plasma needed to manufacture enough Ig for Canadian patients. Most of the rest of the plasma proteins are 100 per cent manufactured from American donors.
Mr. Bees: Prometic is a little different in that we do manufacturing. Most of our material is obviously in development. We’re hopefully going to have a commercial product soon, but we do have a supply from the U.S., and that’s mainly because we’re trying to develop our infrastructure.
In 2015, Prometic bought the Winnipeg centre. It was a six-bed centre and we’ve expanded that up to 30 beds. We’re developing the capacity of that. It won’t be enough.
I had talked to CBS, not wanting to disrupt any of their systems. Our next project is in Buffalo. The facility is virtually complete. We’re in the startup of it now. It’s twice the capacity of what we would have in Winnipeg. We set up in Buffalo because we didn’t want to be disruptive to the CBS. It’s close to the border, but it’s not in Canada.
We would love to be able to work out something where we could pick strategic locations that are not disruptive and work on the Canadian side, but it is what it is.
Senator Oh: Are you aware of the percentage that has to be imported from the U.S. to meet the demand in Canada?
Mr. Bees: Sorry, for the Prometic projects?
Senator Oh: Yes.
Mr. Bees: Right now, it’s mostly from the U.S. I can’t give you an absolute per cent because, once again, I want to develop infrastructure, but it takes time. When we’re fully commercially realized, we would like to have 80 per cent of our plasma internally, and the total amount of what 80 per cent means is really driven by what our market projections are in terms of our products.
Senator Oh: Do you know how much the U.S. pays their donors to get plasma donations? How much do they pay their donors?
Mr. Bees: American plasma collection can be $25 to $50. It depends on the incentive programs they have. Right now, the American plasma market is very overheated. There’s tremendous growth within the United States and, to that end, there’s a lot of competition. We located in Buffalo because there was only one other centre located in Buffalo and it wasn’t competing with us. We wanted to be near the university, similar to our working model in Winnipeg.
Since that time, one of the plasma companies has established ten plasma centres in the state of New York, three in Buffalo.
Senator Oh: So, you import from the U.S. Indirectly we are actually subsidizing the U.S. for the donors?
Mr. Bees: Yes, if you put it that way. Yes.
Senator Oh: Thank you.
Senator Munson: Thank you for being here. I’ll just follow up on Senator Oh’s line of questioning. We’re talking about market prices and setting. I didn’t ask this the last few hearings, but who sets the price? Somebody’s making some money. You have a salary and others have a salary —
Mr. Bees: I don’t work for free.
Senator Munson: I know. If it’s $25, why not $2,500? Who sits in a room and says, okay, we’re going to divvy it up? We have 200 donors and each one is going to get $25. How does that all happen?
Mr. Bees: It’s basically American free enterprise, bottom line. If companies could have people voluntarily donate, they would do that, because it would be a nice thing to do. However, in order to attract donors, it’s all about supply and demand, and as the demand for donors goes up so does the cost for their honoraria. It’s a competitive market.
We didn’t want to get into that type of market. We wanted to be in a more quiet neighbourhood, I guess, not competing directly, because we didn’t want to be in an overheated market.
The bottom line of it in terms of who sets the price of plasma, it’s all about supply and demand. If you look over the last 20 years, most of the supply of plasma has been vertically integrated to the fractionators. So the big fractionators keep getting bigger. As a consequence, the big plasma companies are building more and more centres. So they’re virtually controlling all of their own supply. The number of independents left is very limited now. It’s a totally disrupted market.
Senator Munson: Thank you for that. As you heard some of the testimony here, it’s getting tough for us. This bill may be a simple bill with a short preamble. It’s not black and white, but it’s red and white in a strange way.
What do you say to the Canadian Nurses Association and CUPE? You used the words “kill the bill.” They used the words “we can’t face another tragedy,” even though people say that’s a long time ago and that’s not going to happen again. Every hearing here I walk away conflicted as to which way I should vote.
Mr. Bees: You want my candid opinion on this?
Senator Munson: You’re right here; it’s pretty public and candid.
Mr. Bees: My first inclination is that CBS truly wants to establish a business model for collecting plasma. They want to try to do it on a voluntary basis. I think it’s going to be a difficult thing for them to do, but I still think that they should fund their model so they can prove it out. There are obviously cost issues and there’s availability of donors, if you’re trying to keep it voluntary. But I think that should be encouraged.
Clearly the 50 per cent goal they have, as I said in my introduction, we certainly support that. I think more plasma in Canada can only be good for Canadians in general, whether it’s economic or the ability to control our destiny. I think it’s a solid thing to do.
Having said that, I do think that we have a possibility for public/private partnership. The unions can still have jobs with CBS; have at her, not a problem. We’d love to see the industry grow, so it’s very simple.
The end result is that it’s all about the patients getting the product they need. That’s the critical message on this.
The Chair: Did you want to comment, Mr. Bahardoust?
Mr. Bahardoust: I just wanted to mention that in no way does compensation for plasma donors affect the safety of the finished product. There could be other factors involved that the unions are interested in. Perhaps if CBS is the only producer in Canada there would be more union jobs, but it’s not a safety issue.
Senator Munson: Thank you. In deference to others.
The Chair: I want to follow up on Senator Munson’s question on the remuneration or the compensation because I did go actually this morning to see your website, Mr. Bahardoust.
Some of the witnesses have said that, given that 50 per cent sustainable goal, it’s going to be very hard to compete with the industry. I looked at your website and you do have a very elaborate loyalty programs. Come the first time, you have this; the second time and then I think you have the superhero cards or something like that. What do you say to Canadian Blood Services or to witnesses that say it’s a bit of an unfair competition?
Mr. Bahardoust: It goes back to what I mentioned in the opening remarks that we haven’t seen a negative impact on the voluntary donor model, and the reason is that we’re competing to gain a different pool of donors. I think this has already been mentioned. Only 1 in 60 Canadians — that’s less than 2 per cent — donate voluntarily. Now, about half the population perhaps are not eligible to donate, but still less than 4 per cent of eligible donors are donating voluntarily.
If you have a different model, you are perhaps inviting a different group of people who were not interested in the voluntary donation in any way. There are people who are interested in that and CBS will be able to hopefully attract some of those donors and have a sustainable business and work towards that 50 per cent goal.
A 50 per cent target is extremely high. Héma-Québec started this six years ago. They had a modest 30 per cent self-sufficiency target which they were supposed to get to by 2020, in seven years. They have reached a self-sufficiency target of about 21 per cent.
They can definitely increase self-sufficiency rates. They’re only about 14 per cent right now for CBS, but getting to 50 per cent is a very difficult challenge, especially considering that the demand is increasing by about 10 per cent every year.
The Chair: Thank you. We will ask them those questions for sure shortly.
Senator Kutcher: Thank you very much for your testimony. We’ve heard previous testimony that agrees that, although there was no robust evidence to support current safety concerns in the blood supply, that emergent pathogens — and Zika was identified as one — would put the supply at risk from remunerated donors. Now, would you agree with that, yes or no?
Second, if there were an emergent pathogen that your program didn’t screen out or address effectively in safety work on the product, would that, in some way, substantively differ from the methods that are used by using plasma from non-remunerated donors?
Mr. Bees: I mentioned this earlier when we talked about prions — and Zika is the same thing — it always starts with a risk assessment. Whether you’re being paid or voluntary, it’s still the same sort of risk assessment you go through. You really look at where the outbreak is; what is the potential for people coming back into Canada, in the case of Zika; and then you look at your downstream process.
For blood, it’s a tough call, because you basically infuse platelets or you infuse red cells directly into the body. There is no treatment process, as such, generally, for 100 per cent of all the components used. That’s changing over time, but for now, it’s not the same as the plasma-derived product, where you go through very extensive and elaborate viral inactivation or viral retention with filters, or a variety of other techniques to inactivate the viruses.
Everything stems back to looking at model viruses. Then you use the model viruses to basically verify how your process reacts to a specific pathogen that’s coming in — the emergent pathogen. It’s all about doing the appropriate number of logs of safety factors.
In the old days, if you look at dry-heated clotting factors, it wasn’t quite robust enough to kill the HIV and clearly everything blew up.
Now, we have significant redundancies in the process, and we have to prove that out to the regulator. The regulators have upped their game — Health Canada, U.S. FDA and EMA. We have to be held responsible to prove out that our product can still do what it’s supposed to do.
We have ongoing surveillance reviews. We look at other pathogens, such as hepatitis E and other agents. Even though they are tiny in the number of potential outbreaks there, we still have to satisfy ourselves that they are actually able to mitigate those risks.
Senator Kutcher: I have a clarification statement and a short last question. I understand you’re saying that it isn’t whether the plasma comes from someone who is remunerated or not, the processes are identical for the product safety at the end.
Mr. Bees: Yes.
Senator Kutcher: It’s not the remuneration.
Mr. Bees: No.
Senator Kutcher: Did I understand correctly, or did I make this up, that you had to set up a centre in Buffalo, New York, so that now you can be an American selling to Canada, but you can’t sell from Winnipeg to Canada?
Mr. Bees: When we unveiled our plans for expanding our platform in Canada, one of the things we did is we talked to both blood operators, and I was told that this would be very disruptive to their operations. I basically promised CBS, similar to what I had done when I was in Winnipeg working for Cangene, and said we would not be disruptive and not build a plasma centre until everything was cleared up and we had a clear path forward. So we built in Buffalo to basically verify that we wouldn’t be disruptive to the system.
It’s not a bad location. It’s close to the border. I’m not complaining. I’m just saying —
Senator Kutcher: I’m not casting aspersions on Buffalo.
Senator Omidvar: I’ll try to get as many questions in. Thank you, both, for being here.
My first question is perhaps to Mr. Bees. I would welcome one answer per question, so I can get both questions in.
We know that the laws we have are a reflection of our values. Values do not stay static; they evolve. So our laws also evolve. There is a value in Canada, and increasingly in the rest of the world, that we will not commercialize our bodies. We will not sell our organs; we will not sell blood; rather, we will donate these.
Do you not think that this bill is in keeping with these values?
Mr. Bees: I have plasmapheresed 40 times. I have donated blood 130 times as of yesterday. I have sat on both chairs, literally. Quite frankly, I am proud to be a blood donor, and I would be appalled if somebody were trying to pay me for my blood.
I know that when we run our plasma collection operations, right from the get-go, when Dr. Bowman started the plasma centre in Winnipeg, he felt it was the right thing to do in terms of paying the women, in that case, who had suffered from Rh disease that had the natural antibodies. He felt it was the only appropriate thing to do.
Looking back, from a research point of view — because I used to work in research — clearly, when you work on studies like this, you do give honoraria as part of these things. We had the Bayer Advisory Council on Bioethics, back in the day, review what we were doing in Winnipeg. They thought it was ethical.
I hear what you’re saying. We are collecting plasma, not blood. It’s a renewable resource. It’s replaced in the body very quickly. There is also a side benefit in terms of what the donors are undergoing in terms of health surveillance and the like.
However, I do know, in my heart of hearts, that if we weren’t paying for it, we would not have the donors we actually need. That’s the bottom line. I would love to be able to collect plasma from people voluntarily. It would be a beautiful thing to do. It’s just not going to happen.
In all my years working at the Cangene Centre, the Rh institute centre, we offered people the opportunity to take their honoraria in terms of a cheque or to donate to their favourite charity. I had two people take me up on that throughout all these years.
Senator Omidvar: That’s good to know.
Mr. Bahardoust, last week, we had very powerful testimony from advocates for the public health system: the Canadian Nurses Association, CUPE, et cetera. They firmly believe that a public health system, which is funded by the public, is more transparent and more accountable.
Could you describe to us, perhaps, the measures you take to make sure you are transparent and accountable? Whom are you accountable to? What are the implications for your product and your company should you not meet certain benchmarks by whichever oversight body that governs your industry?
Mr. Bahardoust: First off, I want to clarify that we are only talking about collection of plasma, which is an integral part of the manufacturing of medications. We are not a health care provider. There is no provision of health care at our facilities. We just strictly screen donors to ensure that it’s safe for the donor and the product is safe for further manufacturing.
We are regulated by Health Canada, the same agency that regulates Canadian Blood Services. Additionally, we are licensed by the European Union; we are registered by the FDA; and we are a PPTA-sourced member and certified by their standard, IQPP. We meet and exceed all the standards that CBS meets.
If millions of dollars have been invested in setting up a facility such as ours, if a bad unit is collected, as the nurses’ union suggested, because we are for-profit and we don’t care, the whole operation is jeopardized. This insinuation that for-profit means unaccountable or something for profit does not care about the patient is just false.
If the public sector actually did something wrong, what might happen is that some management would be changed, they would rebrand it and they would continue, but the private company would be done with. This is just not correct, in my opinion.
Senator Omidvar: Thank you.
Mr. Bees: To quickly follow up on that, maybe I’ll give you an example of what I actually had seen through my career in Ireland where they had an anti-D fractionation process, very tiny and similar to Winnipeg. They had collection from donors, very similar to what we had in Winnipeg. The difference was they didn’t have all the safeguards in place they needed to have. They actually transmitted Hepatitis C to not just the final product, but they actually infected the donors through contamination.
The bottom line on it is that they don’t exist anymore. They shut the thing down immediately. We sent our WinRho over to Ireland to help them out of a bind because they needed product very badly. So, when you make mistakes like this, you aren’t going to be around much longer. The point is, you shouldn’t get to that point now. In the old days, it would get to that point. It should never happen.
Senator Omidvar: I have a little question addressed to Mr. Bahardoust. You said that if this bill is passed, the only paid donors will be U.S. donors. When I read the bill, what it actually says is that the only agency that can pay for plasma is the Canadian Blood Services. Would you respond to that?
Mr. Bahardoust: The CBS’s goal is to collect 50 per cent plasma. The rest is going to be imported if there is no other Canadian supplier, and all the other supply available is from paid donors. Based on Canadian regulations, the only plasma that is approved for use for final product, besides Canadian-sourced plasma is U.S.-sourced plasma. So, by default, basically, everything else that we are going to be importing to supplement that 50 per cent, assuming that the goal is reached, is going to be U.S. paid donor plasma.
[Translation]
Senator Mégie: I would like to know what percentage of plasma that comes from paid Canadian donors comes back to Canada in the form of drugs—immunoglobulins, and so on. What is the percentage?
[English]
Mr. Bees: I can’t give you a specific percentage. Right now, the Winnipeg centre probably about 60 per cent of its plasma is fractionated in Canada, in terms of the specialty antibody-type programs. I don’t have the details in my head in terms of what that translates to.
Clearly, we supply Emergent with anti-D, and they in turn supply the blood operators with anti-D immune globulin. Up until recently, we supplied 100 per cent of our plasma to that operation, so clearly the majority of our plasma was going into the Canadian operation. The Prometic R&D program that we have, it has been going into fractionation in Canada and that material has been used in clinical trials in North America and in Europe, and so it’s not commercial yet. In future, we will be licensed in Canada and the U.S., and later Europe.
[Translation]
Senator Mégie: Speaking of these clinics, how much do you invest in research and development for plasma-derived drugs?
[English]
Mr. Bees: You’re asking basically is what is our R&D budget in Canada for Prometic?
[Translation]
Senator Mégie: Yes. Do you have a budget dedicated to it, or have you invested?
[English]
Mr. Bees: I’m the operations guy; I can’t comment. I can find out. It’s probably a matter of public record, but I just don’t know. They spend a lot of money on clinical trials.
[Translation]
Senator Mégie: At Prometic Plasma Resources, you fraction the plasma, right?
[English]
Mr. Bees: The plasma is fractionated at Emergent in Winnipeg. It’s also in Laval, Quebec.
[Translation]
Senator Mégie: You have never tried to fraction for Héma-Québec or Canadian Blood Services?
[English]
Mr. Bees: Not yet. The conversations we had with both Héma-Québec and CBS is that once we have our proprietary fractionation process up and running, and that’s validated and licensed by the appropriate authorities, we would love to be able to entertain a bid to supply product to both blood operators, but we’re quite a way away from that yet.
We have an IVIG that has gone through phase 3 clinical trials, but it hasn’t been commercialized yet. With the plasminogen product, we are in the midst of final licensing on that. We have had conversations with both sets of regulators, the U.S. and Canada. We would love to do that in the future. That’s our business plan.
The Chair: If you do have that data, we will welcome it.
Senator Eaton: I’ll start off with a comment. I find it sort of interesting that we will use paid blood products imported from the U.S., while we ban them in certain provinces here. I just find that kind of illogical.
Anyway, to continue, is there any country in the world that has become self-sufficient without paid blood products? Europe has free medical systems, very good medical systems, some of them. Do they all operate on a free blood system or do they have paid clinics? Do you have to pay for the plasma or you get paid to give plasma?
Mr. Bahardoust: The answer is no, there is not a single country in the world that has reached self-sufficiency for plasma protein products through solely voluntary model. Now, there are many countries that in Europe that have high self-sufficiency rates, but again, in most of these countries the donors are incentivized. Out of the 28 EU members, 16 of them have some form of incentive programs for donors including —
Senator Eaton: Both blood and plasma, or just plasma?
Mr. Bahardoust: Mostly just plasma, but some for blood, too, including the 10 largest ones by population, starting from Germany to Greece.
In many cases, the compensation in those countries far exceeds the monetary compensation that we provide to Canadian donors, which is more in line with the U.S. style.
For example, in Italy, the donor can get an equivalent of up to over 100 Euro, but it’s not cash. It’s time off work or pay in lieu of work. In some other countries, like Germany, the donors can get paid cash.
This goes back to Senator Munson’s question. In Europe, there is a lot of regulation about this, around this. They have set rules, for example, in Germany, Austria, Czech Republic and Hungary, as to what is an acceptable level of compensation.
In Canada, we follow the same model as the U.S., basically, where the market sets the price and, as competition has been intense for recruiting donors in the U.S., the compensation values have gone up in the U.S. in the last couple of years.
Senator Eaton: Explain something to me. You have a centre in Winnipeg and a centre in Moncton. You collect plasma. You pay for it. You ship most of that to the United States?
Mr. Bahardoust: No, we operate the centre in Saskatoon, and one in Moncton.
Senator Eaton: Yes.
Mr. Bahardoust: The Winnipeg facility is separate.
Senator Eaton: So all the plasma you collect in Saskatchewan, does that go to patients in Saskatchewan?
Mr. Bahardoust: No. We have made several offers to CBS to purchase plasma from us.
Senator Eaton: So CBS doesn’t yet.
Mr. Bahardoust: There is no other large scale fractionation facility in Canada at the moment. There is one being built in Quebec, which is not licensed yet. We ship all of our plasma to Germany at the moment, where it gets fractionated.
The CBS doesn’t purchase any product from us. At the moment the only product from that fractionator that comes into Canada in small quantities is their CMV antibody plasma that I mentioned, which comes through special access programs. Physicians directly buy that.
Senator Eaton: You send your product to Germany. It’s fractionated. Does it come back to Canada?
Mr. Bahardoust: No, CBS doesn’t purchase the product.
Senator Eaton: You sell it in the United States or wherever.
Mr. Bahardoust: In Europe, in the EU.
Senator Eaton: We give ours to Germany, then we buy from the States so it’s a full circle.
Mr. Bahardoust: Yes.
Senator Eaton: Thank you. I had to see the circle.
Senator M. Deacon: Thank you both for being here today. I appreciate your information and clarification; especially your perspective and the clarification around for-profit, not-for-profit, private, commercial and perceived risk, et cetera. Thank you both for responding to that earlier.
Senator Eaton talks about seeing a circle. I still am struggling with it. If we’re buying products in plasma to help Canadians from other countries, why isn’t that money going to Canadians to pay for plasma here, in a greater degree. It’s something I’m still trying to work through.
Mr. Bahardoust, you talked earlier at the beginning of your speech and you were going through a number of things where you talked about why plasma is more difficult. You talked about four times longer; folks are expected to be back more frequently; there is a block of time that they are here for.
Then, I think — I didn’t catch it, I want to come back to this — then you talked about the cost of finding donors. Then there was something precise you said after that, that if we’re doing this with volunteers, the cost of finding donors is X, but if we’re paying, the cost of finding donors is Y. Could you come back to that? I truly missed it.
Mr. Bahardoust: Yes, I actually didn’t mention a specific cost, but I referred to Health Canada’s expert panel report that noted that the cost of collecting large volumes of source plasma using volunteer donors is two to four times more expensive than the commercial plasma collection model.
Senator M. Deacon: Two to four times more.
Mr. Bahardoust: Just giving you some numbers, the offer that we gave to CBS — and we have made it public — is for them to purchase our plasma at $195 per litre. But the proposal that they have given to the provinces is to collect plasma at a cost of $405 per litre, that is if they meet their target. That’s already two times more.
I think the four that Health Canada is referring to is the fact that, based on evidence, usually in the experience of other jurisdictions, usually the agencies like CBS will not meet their target. If you look at their current collection costs, they are more like four times, or somewhere between two and four times. That’s the number that I was referring to.
Senator M. Deacon: Okay. I feel like I’m missing a piece when we look at this. I know the wording of the bill is one issue. Of course it is and we’re looking at what that language is in the bill. We hear language that we’ll do better. We’ll attract more Canadians. We’ll make this more appealing for Canadians to donate plasma. We’re going to have these targets that CBS can achieve.
Is there something that is not being tried as a strategy that people are thinking about, but that we haven’t done yet that might increase plasma donors that is not payment? Maybe I’m missing something, so that’s what I’m trying to understand.
Mr. Bees: Just to clarify, you’re asking us to speculate on what CBS or Héma-Québec should be doing?
Senator M. Deacon: Not maybe what they are doing, but perhaps in some of your conversations that are at different tables than the tables we’re at here, perhaps there are suggestions that people have chatted about that are going to increase our number of plasma donors that is not incentivized. What is it?
Mr. Bees: I think what needs to happen is you need to get to know what your prime demographic is. I think that’s the 18 to whatever. The young guys, right? Young and healthy. You need to understand how they think and what motivates them to donate.
From what I understand, other countries have tried providing time off work, and have tried a number of other things in kind. But at this point — in fairness to CBS — they have not set up their model yet. It is in its infancy.
Héma-Québec has done a nice job of setting up in malls, so they have the nice little plasma centres in the malls in Laval that I have seen, once again trying to make it convenient for the donors, with lots of parking, excellent ideas. Once again it’s a slog to make that happen.
Senator M. Deacon: Thank you.
Senator Forest-Niesing: Most of the concerns that I had have already been touched on. Having come to understand a little better, in fact from zero to what I understand now about plasma collection and the fractionation process, I realize that many donors are required to treat only one patient. Not only many donors, but much time, sometimes up to a year for the fractionation process to occur.
Given that disproportionate impact on supply and demand, I’m interested in knowing how you, in each of your enterprises, established your donor base. How do you arrive at the level that you are at now?
At what point, or how long would you estimate it took you to arrive at — and you know I realize ideal levels are perhaps pie in the sky — but at the satisfactory level that you would describe to me?
Mr. Bees: The Winnipeg centre is somewhat unique in that it started out of a doctor that was treating women that had Rh disease so these over 40 women were totally under Dr. Bowman’s spell in terms of wanting to save babies and help other women that have suffered. It wasn’t so much a recruiting effort, as more of an organizational effort. It’s a huge success story. But those women have all moved on, because they obviously got beyond their years in terms of donating.
We have had to very carefully advertise for specific people that fit a very narrow criteria in terms of being able to line them up. That’s an ongoing issue that we have had. We have done a good job maintaining our donor base. We haven’t been actively growing it because it’s not something that we’re growing at the present time, but it’s still a very viable program.
On our other programs, we have added more chairs into our centre. We have had to change our marketing approach, with a lot of social media, trying to get in touch with our donors in terms of what works for them, what do they latch onto in terms of ideas.
We certainly have leveraged off PPTA’s program when you’re connecting to the patients. That’s a huge thing, just lighting up the altruistic elements in brains. It’s not about the money so much. You’re paying them for their time, but you want them to show up to actually give back to the patients. That’s a huge piece of the marketing thing.
Coming back to it, are we satisfied with where we’re at today? No. I think we could do much better. We’re continuing to grow the program ever so gently. In Buffalo, it will be a little different because it’s a different, much larger campus, with more potential donors and more people in the surrounding area that would fit our market. But we’ll find out.
It’s not easy. For CBS — and Héma-Québec is already finding this — it takes a long time to establish that base. Once you have them, they can be fiercely loyal, but it’s not for everyone.
It’s a tough thing, undergoing pheresis. Other than my travel interview on my blood donation yesterday, the actual donation happens just like that. When you go for plasmapheresis, you’re in the chair for some time. It takes a long time. If you’re not prepared to spend that time, you shouldn’t be a long-term donor.
The Chair: Did you want to add something to that, Mr. Bahardoust?
Mr. Bahardoust: We have recruited close to 5,000 donors total in both cities, so far. Most of the advertisement is through social media and online advertisements, but we did some traditional advertisements initially. Most of our donors come through referrals and word of mouth.
It takes about four years, in our experience, for a centre to mature. We hope that in the future we can be more efficient, but that’s where we’ve been so far. We are not where we want to be. We still want to grow from there.
In our specialty program, it’s much more difficult to get those donors. At the moment we still have fewer than 100 donors. That’s why it’s not feasible to run specialty programs, like the one they also have at Winnipeg alone in a centre. You need both programs to run at the same time, because those donors are very rare.
Senator Forest-Niesing: Given the amount of time — I think your reference was four years — to arrive at a reasonable donor base, and given what you’ve described, Mr. Bees, as the number of initiatives that you have to throw at building that donor base, if this bill passes and it is no longer possible for either of your enterprises to make use of that invaluable donor base, how confident are you — having become familiar, I’m assuming, with the plan that’s being proposed by CBS — about the situation, if we’re talking about four years, between the moment that the bill passes and the prohibition exists and the four years until CBS’s plan can produce a reasonable donor base?
Mr. Bees: You know, on the specialty side, if we shut down tomorrow, we would lose all the anti-D donors. They’d be gone. It’s not in the bandwidth of CBS to collect anti-D. That’s not their mandate. Their mandate is to collect regular-source plasma to produce IVIG and the mainstay products, not the specialty products. So that would be gone.
As far as would some of the donors in Winnipeg go to the CBS for voluntary donations, I don’t think so.
The flip side of it is CBS’s plan is to pilot three specialty plasma collection centres. I assume they’re going to be in Ontario, Alberta and B.C., but I could be wrong. If that’s the case, it’s going to take them several years to establish those operations, and probably several more years to establish the cost efficiency of these things.
I can guarantee that the people in Winnipeg are not going to be donating for at least five or six years, based on that. Even then, I think that they probably would not be incentivized to, unless CBS changes its incentive program.
Mr. Bahardoust: The four years I was referring to was in our model.
Senator Forest-Niesing: Yes.
Mr. Bahardoust: Based on Héma-Québec’s annual reports, none of their Plasmavie centres have reached their goals so far. They’re all running at between 30 and 70 per cent of the original target. Some of these centres have been operating for six years now.
So, for CBS, unless they do something very different from what Héma-Québec is doing, they might never reach those targets, or it might take them 10 years.
Senator Forest-Niesing: Thank you.
Senator Dasko: I think we’ve learned a lot about donors, who they are and the types of donors you have. I wanted to ask you a couple of questions about your customers and your clients. Mr. Bahardoust, you said that you had one customer and that is a customer in Germany?
Mr. Bahardoust: Yes.
Senator Dasko: Is that a central agency that you have that you provide to? I’m wondering if you can tell me as much as you can. You don’t have to reveal names.
Mr. Bahardoust: There are only a few fractionators globally, so our potential pool of customers is small.
Senator Dasko: Your customers are fractionators?
Mr. Bahardoust: Yes. Our customer is a German fractionator. There are a few other ones, basically, globally, with the exception of potential customers in China or some other jurisdictions. Because of much lower standards, it does not make sense to collect plasma in a highly regulated environment and sell to a jurisdiction where the cost of collecting is much lower. In Europe and the United States, there are only a few fractionators.
Senator Dasko: So you have clients who have high standards?
Mr. Bahardoust: Yes, and there’s only a handful of them. We work with a German fractionator. All of these larger fractionators, with the exception of LFB, which is the French fractionator, are for-profit companies. But some of them, at some point, were part of the national blood organizations, but they got so big and were spun off and now operate as a for-profit.
Senator Dasko: Mr. Bees, who are your clients?
Mr. Bees: The main clients would be Prometic, in Laval, Quebec, the parent. When we bought the centre, the understanding was we would continue to sell anti-D plasma back to Emergent, because they obviously have an ongoing need to produce anti-D immunoglobulin. We’ve been successful with that.
We’ve actually worked with them on some developmental projects. We collect plasma from immunized donors for phase 2 clinical studies. If it proceeds to a phase 3 and ultimate licensure, we obviously would like to continue that program for them.
We had additional capacity this year, so we’ve been able to establish another customer which actually distributes its anti-D back into Canada.
Senator Dasko: I see.
Mr. Bees: Our main focus is to collect plasma for Prometic, because we want to develop our own products, plasminogen being the lead.
Senator Dasko: Basically, you have one main client and not a whole bunch of smaller clients?
Mr. Bees: Yes.
Senator Dasko: I’m interested in the Ontario market. Where does Ontario buy plasma products from? We know donors cannot be paid in Ontario, the biggest province in Canada. Obviously, there is a huge need for plasma products. Where does Ontario get its plasma products?
Mr. Bees: All of the plasma products for Ontario are arranged for through CBS tenders. So Canadian Blood Services manages a very large tender and they supply all of Canada. Ontario’s obviously one of the key beneficiaries of that.
Senator Dasko: But neither of you are able to sell your product to —
Mr. Bees: Once we have a licence, we intend to have CBS and Héma-Québec distribute our Plasminogen product, but we’re not licensed yet.
Senator Dasko: So it’s done through the blood service? It’s not done through any lower-level —
Mr. Bees: It’s a tendering process, yes.
Senator Dasko: Those are my questions. Thank you.
The Chair: Did you want to add something, Mr. Bahardoust?
Mr. Bahardoust: CBS is responsible for the provision of fresh blood products. They collect that. In terms of dollar amounts, that now accounts for about one third of what they do, and almost 60 per cent or higher of their budget is solely for purchase of products. They’re just a distributor. They purchase these products through the tenders and they distribute them to the provinces.
The Chair: Thank you.
Senator Moodie: Thank you, Mr. Bees and Mr. Bahardoust, for coming here and helping us understand more about this problem and the considerations in front of us today.
We’re struggling a little bit with trying to understand what the essence of this issue is. We’ve heard a lot about supply and demand — lots of compelling discussions about need, supply and the particulars of where and to whom it’s going.
We’ve also heard that regulation is in place. You frequently have oversight by the necessary bodies. We’re also hearing that reporting is in place, as well as appropriate storage, collection and traceable product. We’ve heard that you’re able to trace infection control back to the suppliers, and that there are huge consequences.
We’ve heard all of that. We’re struggling with what the problem is. I think the problem may actually lie a little bit in the arena that my colleague Senator Omidvar raised; namely, the area of bioethics and the whole question of what the ethical consideration here is that we’re struggling with as a country. Is that the issue?
I very specifically want to ask Mr. Bees: Can you expand a little bit more around the deliberations your bioethicists considered in the Winnipeg project? If you can share with us some of the things you talked about —
Mr. Bees: Do you want me to go back to Krever and start there?
Senator Moodie: Let’s talk about it.
Mr. Bees: Okay, sure.
Senator Moodie: Some of the issue here is the difference between incentivized versus direct payment and which is more palatable to us as a people. I think we need to look at this, because this may be the issue we’re struggling with.
Mr. Bees: Fair enough. Going back to Krever, Justice Krever did spend some time looking at our program in Winnipeg. He actually made a notation in his recommendations as part of his overall report. The bottom line is that he looked at the fact that we had these donors, not all women but mostly women at the time — and it’s obviously changed a little bit over the years, but it’s still the same basic concept — and the fact that these people not only had to be a regular donor in order to be able to contribute to this overall process, but they also had to undergo ongoing injections of the red cells to boost their antibody titres. It’s not for the faint of heart.
Clearly, if you’re a new donor, not one that had natural immunity — I’ll back up a little bit. For anti-D, the success of our anti-D program is that we virtually killed off all of the natural immunized donors, because you don’t want to have a naturally immunized donor; you are trying to prevent that. So it’s been very, staggeringly successful. We take someone who is post-menopausal or a male, and immunize them with red cells, if we get the appropriate phenotype match.
It’s an issue in terms of them undergoing that. They’re constantly being surveyed in terms of their antibody titres, and we want them in the program for a long time. Compensation is a way to do that.
Interesting enough, Dr. Bowman, who had started with the Canadian Red Cross — he was a medical director there — was obviously used to not paying donors, because blood donors never got paid in Winnipeg ever. He made an exception in terms of these women, because of the type of program they had.
Justice Krever reviewed that and felt it was an appropriate thing to do. From a safety point of view, he didn’t have any issues and, from an ethical point of view, he felt it was the right thing to do.
I’ve been involved in ethics discussions with the Bayer bioethics committee. They reviewed the same thing, and their report came to a similar conclusion, specifically on anti-D.
More recently, with PPTA, there have been some bioethicists working in the industry examining the ethics of paid donation. When you expand that concept to the patients and the greater good for patients to have an adequate supply, the question almost flips over 180 degrees: Is it ethical not to pay people who have to have such a significant contribution in terms of time?
I donated yesterday at the CBS centre. I zipped downtown, got in, did my quick donation and went out. I don’t go back now for 56 days at the earliest. It’s not a big deal for me to be able to continue to do that. If I were doing that once or twice a week, then it would be a significant thing in terms of time out of my life. If you want to have that reliable supply of product, then it’s the right thing to do.
The flip side of it is that, by having these regular donors, and you have them closer connected to the patients, then you have less of a chance of them thinking, “Oh, I’m feeling a little bit sick today, but I really want the money.” They don’t do that. They’re that well connected; it’s like a family with the donors who come in.
I’m not an ethicist; I don’t pretend to be. But when I hear ethicists talk about this, I always come back to the patient and put the whole thing together in a package. That’s just me.
Mr. Bahardoust: I agree that the ethics question is important. I think you received a letter from ethicists already.
My point here is that this bill, I don’t think, has anything to do with the ethics issue. If compensation was an ethical problem, you could not exempt the CBS, which is the sole supplier, to compensate donors directly or to continue to import paid plasma products indirectly from the United States.
The ethics question is important, but we have to be consistent. If payment, for whatever reason, is unacceptable in Canada — and there has actually been some research in this regard, as well; there have been studies. Most Canadians support compensation for plasma donors — 75 per cent, in fact — and that number increased to around 90 per cent if they knew that if there was no compensation that we had to import products into Canada.
If, for whatever reason, we are going to ban compensation for plasma donors, we have to be consistent and say, “Okay, we’re going to pay two, three or four times more, because that’s our value, and we’re going to just do it on this basis. We might face shortages, but it is our value and this is what we want to do.”
This bill is not about that. This bill, as Senator Omidvar pointed out in one of the previous hearings, is to provide a monopoly for CBS so they can collect the plasma with no competition at whatever cost that would be.
It’s important also to remember — and I think Bill pointed to it — that this is about the supply of raw material for the for-profit industry. We are not talking about collection of whole blood from volunteer donors that goes to hospitals. We are talking about raw material for the for-profit industry. Everybody is making money off this, except the donor.
I don’t see any harm in the donor also being compensated for their time for doing this. They can donate up to twice in the United States. We collect plasma donations once per week in our facilities, but that’s a very huge time commitment; it’s at least two hours every week.
The Chair: We do have time for a second round of short questions and short answers. Before we move to it, I have a question.
A lot was covered, and the one thing that was not covered today but which has been in other meetings — and it has come in the past as some critics — is the choice of locations. Where are these facilities built? Some suggested that the choice of the location targets not only students but really vulnerable populations. This was an issue raised in this committee.
I wanted to not only have your input on that, but I wanted to know specifically: Is there any criteria that you have to follow as to where you can or cannot be? I know there is screening, so that takes in some of those concerns. But I really wanted to have something tangible as to if there are criteria on where you can actually build something.
Mr. Bahardoust: I want to start off by saying that for vulnerable individuals, or those for whom it’s not safe for them to donate, cannot donate based on the regulations. We not only screen to ensure that the end product is safe, we also screen to make sure it’s safe for the donor to donate. For example, homeless individuals cannot donate plasma. We also follow IQPP standards which are much more strict than Health Canada regulations alone or what CBS follows.
We are set up in a light industrial zone in Saskatoon. We are not in the downtown. Health Canada has obviously been informed about our location prior to proceeding with the application. We are certified by IQPP and EU; they all look at this.
There is no specific set of rules for finding a location based on the Canadian regulations, but they have all looked at it. It is in our best interests that we can be in a location where we can accept donors that are qualified.
If we cannot get those vulnerable individuals who are eligible to donate, why set up in an area where all the donors are disqualified? Some people insinuate if someone’s income is below average, then their plasma or blood is not good. That is not the criteria Health Canada uses. There is a lot of discrimination when it comes to choosing the donor, but the donor’s income is not one of them.
Mr. Bees: Just very quickly, there are specific facility standards that IQPP has with PPTA that have to be followed. I won’t get into the great details with that. We can supply you with the actual standards.
More importantly, there are disease standards. The proof is in the pudding in terms of when you have donors coming in, they look at your disease rate. If your disease rate actually goes up to a certain level, you can lose your licence, and that’s really reflective of the type of donors you’re bringing in, regardless of whether you’re in a poor part of town or whether they would drive all the way to a better part of town to actually donate; probably not very likely. Lots of times, people will relocate centres into better areas to prevent that from happening.
Mr. Bahardoust: I’m going to expand on that and it refers back to what I had in my opening remarks. With the viral alert limits, we had zero cases of confirmed positive cases for the 40,000 donations that we had. PPTA standard allows for a composite of eight per 100,000. Both CBS and Héma-Québec have, respectively, 13.3 and 11.3 confirmed positive cases for 100,000. So CBS and Héma-Québec do not meet the IQPP standard in terms of the limit.
Mr. Bees: Keep in mind, they’re blood.
Mr. Bahardoust: Yes, I do, but the point is the donor screening is more strict in the plasma industry.
The Chair: Thank you for this. We’ve had some new names, so we’ll ask for your collaboration for the questions to get even a little shorter and the answers as well, just to make sure everybody has a chance.
Senator Seidman: Chair, you asked the question that I was going to ask about the location of clinics and the criticism that we heard about where you locate clinics in vulnerable populations, but we’ve already had the answer to that.
The burning issue for us really is that it just feels plain hypocritical to purchase plasma products collected through payment of everyone but Canadians. There’s just something basically not right about that. In fact, the proponent had said none of the blood that is collected from paid donors in Canada stays in this country.
Is that indeed the case, that none of the blood that’s collected from paid donors, plasma, of course, stays in this country?
Mr. Bahardoust: Again, I think I mentioned that in the opening remarks.
Senator Seidman: Right.
Mr. Bahardoust: The answer is yes.
Senator Seidman: Yes.
Mr. Bahardoust: The only reason we have to do that is because CBS is not purchasing these products —
Senator Seidman: Right.
Mr. Bahardoust: Based on the system that we have in place in Canada, we do not have an option to distribute products ourselves. So that’s a decision by CBS —
Senator Seidman: Right.
Mr. Bahardoust: — and Héma-Québec.
Senator Seidman: That just makes it really clear and crisp. I thank you for that. It is an important fact to understand, that we’re bringing in blood products paid for and that we don’t allow that we use the paid-for products from Canadians right here in our own country. I think that’s the main point to take away from this. Thank you.
Senator Ravalia: Just a point of clarification, and this is with respect to the safety issue. For direct plasmapheresis, you have very strict criteria. Some of our plasma is also sourced from excess whole blood collection. Does that meet the exact same standards as plasmapheresis, or is that a potential weak link in terms of disease dissemination?
Mr. Bees: It’s an excellent question. I think the bottom line is that you can’t have exactly the same testing going on in a recovered unit than a fresh unit because they’re not fresh by definition.
Senator Ravalia: Correct.
Mr. Bees: We do have standards around recovered plasma collection, and it’s well established in the industry of people doing this. From a manufacturing control point of view, the controls would be the same in terms of once it gets into fractionation. From that perspective, I’m quite comfortable that it should lead to good-quality product.
Clearly, it’s just a byproduct of our blood system and not utilizing all the widgets. Recovered is a great source of antibody, because the antibodies are much higher. It’s a positive thing for IVIG. It totally can’t be the same because it’s a different process, but it’s as close as you can get.
Senator Ravalia: In real life, we don’t see a tangible difference?
Mr. Bees: No.
[Translation]
Senator Mégie: My question is for Mr. Bahardoust. When the Canadian government decided to ban paid blood donations in 2014, your company threatened to take legal action, given the millions of dollars you had invested to set up the project. Have you initiated that lawsuit?
[English]
Mr. Bahardoust: It wasn’t the Canadian government. The Ontario government at the time, yes. No, what happened was that we knew that the bill was proceeding and we got in touch with some other provinces, and some other provinces actually reached out to us. The timing at the end of the day led to us obtaining our Health Canada licence before the bill was passed in Ontario.
Our concern was that if the bill was passed before we got our Health Canada licence, then we might have to go through the whole process and waste a couple of extra years. That didn’t happen. There are other provinces that would be happy to help establish the plasma industry in Canada and we located that facilities. We didn’t pursue any legal action.
[Translation]
Senator Mégie: Did you take advantage of the openness of the other provinces when you decided not to proceed?
[English]
Mr. Bahardoust: No. It was nothing like that. Every province in Canada, with the exception of Quebec, allowed compensation for plasma donors. This, I’m going to emphasize, was not a loophole. This was specifically built into the Trillium Gift of Life Network Act in Ontario. So you could not compensate donors of organs or tissue, but blood components, as long as they were used for pheresis manufacturing, was explicitly exempt.
When we were reaching the point that we were going to obtain our Health Canada licence, after years of review by Health Canada, the Government of Ontario decided to amend the Trillium Gift of Life Network Act, and introduced other legislation to prohibit compensation for plasma donors. So we could not operate in Ontario. The other provinces did not have such prohibition and the other provinces told us that they had no intention of changing their position. So we relocated there.
Senator Kutcher: We are not hearing that there are any substantive medical issues for remunerated donations. We are not hearing there are substantive ethical issues for remunerated donations. Your work is part of an emerging nascent and important biotech industry in Canada. If the kind of approach to other biotech industries that we see through this bill was being applied to your industry, what impact do you think it would have on the growth of Canada to be able to commercialize and be successful in the biotech sector?
Mr. Bahardoust: I am not sure if I understood the question completely, but if the bill is passed, our operation will cease to exist. We will not be able to recruit donors, as mentioned. We had about 75 employees last year. Senator Ravalia asked this question before about the economic impact.
Two of the 26 PPTA source members are Canadian. In terms of the size of our operations, we are still very small, but the industry is very large already and it’s growing very rapidly. By 2024, this industry will be about $45 billion a year globally and Canada could potentially have a big part of that. If this bill is passed, none of that will exist.
Even operations like the Green Cross, where they are going to be further manufacturing the plasma, will have to import all of their raw material. Most of the employment would be in collection. For example, that facility which is being set up at a cost of around $300 million will employ somewhere around 200 to 300 individuals. The plasma collection centres that supply that facility would employ more people. A large part of the value added is the plasma. Again, if this bill is passed, all the raw material has to come in through the United States or other jurisdictions of paid donors.
Mr. Bees: It’s kind of an unusual situation, because when I got into the industry, there was Connaught in Ontario, Institut Armand-Frappier in Montreal and the Rh Institute in Winnipeg. None of them are really part of this today. Now we have the Green Cross in Montreal; we have Therapure in Mississauga; Emergent in Winnipeg; and Prometic in Laval, and probably Belleville in future.
We actually have a very nice future industry developing in Canada, which is tremendous, because it wasn’t like that recently. Here we have an opportunity to actually grow it. As I said earlier, I think it’s a great way to grow it with CBS and the private guys working together on it, because there is enough capacity for it to be a good fit.
Senator Omidvar: I have a very short question for both of you. Would you like to propose amendments to this bill? If so, what would be their nature?
Mr. Bees: Senator Wallin’s office reached out to me recently because they wanted to clarify something related to specialty plasma. I read the bill and I read it again this morning, and the way it’s worded, about rare phenotypes, it doesn’t apply to any of the plasmas we do, including anti-D. Anti-D is the second-most common blood antigen, outside of ABO; 16 per cent of Caucasians don’t have it, unless you’re Oriental, which is like less than 1 per cent. When you look at all of Canada, it’s not a rare phenotype. All the specialty things we produce are not rare phenotypes. They will essentially shut down specialty plasma, period, the way they worded it.
I just look at it from the point of view of, we already have legislation in the provinces. Typically, this would be a provincial concern, not a federal concern. Health Canada’s role is to regulate, and they do a good job on that now. It’s typically a provincial jurisdiction around spending and health care. It’s not typically a federal one. Federal is more coordination. That’s my humble opinion.
Mr. Bahardoust: My suggestion would be that plasma for further manufacturing would be exempt from the bill, but the whole purpose of the bill is to shut down the plasma industry, so there is no reason to move forward.
[Translation]
The Chair: Thank you very much.
On that note, we will adjourn today’s meeting. We will continue our study of this bill tomorrow.
[English]
We will hear from the Canadian Health Coalition; the Canadian Hemophilia Society, British Columbia Chapter; and the Sickle Cell Disease Association of Canada.
I want to thank our witnesses for their time and answers, although I do have to say that their answers also triggered new questions, I suspect.
I also want to say that when we return from the break we will have with us a bioethicist and we are also reaching out to have Héma-Québec and CBS. Thank you again.
(The committee adjourned.)