THE STANDING SENATE COMMITTEE ON SOCIAL AFFAIRS, SCIENCE AND TECHNOLOGY
OTTAWA, Thursday, March 21, 2019
The Standing Senate Committee on Social Affairs, Science and Technology, to which was referred Bill S-252, the Voluntary Blood Donations Act (An Act to amend the Blood Regulations), met this day at 10:30 a.m. to consider the bill, and in camera to study a draft agenda (future business).
Senator Chantal Petitclerc (Chair) in the chair.
The Chair: Good morning everyone, and thank you for being here with us today. Welcome to the Standing Senate Committee on Social Affairs, Science and Technology.
My name is Chantal Petitclerc. I am a senator from Quebec, and I am very pleased to have the privilege of welcoming you and of chairing this meeting.
Before we give the floor to our witness, I would like to ask my colleague to please introduce themselves.
Senator Seidman: Judith G. Seidman, Montreal, Quebec.
Senator Poirier: Welcome. Rose-May Poirier from New Brunswick.
Senator Eaton: Thank you for coming. Nicky Eaton, Ontario.
Senator Ravalia: Good morning. Welcome. Mohamed-Iqbal Ravalia, Newfoundland and Labrador.
Senator Oh: Victor Oh, Ontario.
Senator Forest-Niesing: Good morning, and thank you for being here. Josée Forest-Niesing from Ontario.
Senator Dasko: Donna Dasko, Ontario.
Senator Kutcher: Stan Kutcher, Nova Scotia.
Senator Moodie: Rosemary Moodie, Ontario.
The Chair: Today we are continuing our study of Bill S-252, the Voluntary Blood Donations Act (An Act to amend the Blood Regulations). With your permission, before giving the floor to our witnesses, I’d like to say something.
It’s always good to share the good work of this committee, and if you have paid attention, you will remember the study we did at committee, The Federal Role in a Social Finance Fund, and you will be pleasantly informed, if you are not already, that the new budget announced $700 million on a social finance fund in this budget.
It reflects on the good work that this committee does, and I want to recognize the work of Senator Omidvar, who brought forward the idea for this study. Let’s begin with our witnesses. We’re pleased to have you with us.
Today we are pleased to welcome, as an individual, Dr. Penny Ballem, former chair of the Health Canada Expert Panel on Immune Globulin Product Supply and Clinical Professor of Medicine, University of British Columbia; from Héma-Québec, Dr. Marc Germain, Vice President, Medical Affairs and Innovation, and finally, from Canadian Blood Services, Dr. Graham Sher, Chief Executive Officer.
Thank you for being with us. I want to remind that you have seven minutes for your opening remarks, and it will be followed by questions from the senators.
Dr. Penny Ballem, former chair of the Health Canada Expert Panel on Immune Globulin Product Supply, Clinical Professor of Medicine, University of British Columbia, as an individual: Madam Chair and honourable senators, thank you for giving me the opportunity to speak to you about this bill. I would like to thank my eminent colleagues, the vice-chair, Francine Décary, and the two special advisors, Dr. Patrick Robert and Dr. Merlyn Sayers, for their excellent work and their contribution to our report and to this file.
I am a clinical hematologist. I grew up in Quebec, trained in British Columbia and spent three years at the Puget Sound Blood Center, training in transfusion medicine after my clinical training in Canada.
For six years I was the Deputy Minister of Health for British Columbia, and during those six years, from 2001 to 2006, I was the liaison deputy for the Federal-Provincial-Territorial Council of deputy ministers of health for the transfusion service. I worked at that time with Dr. Sher, who had just come in as the President of the CBS. For nearly seven years, I was the Deputy Medical Director of the Canadian Red Cross Transfusion Service from 1985 to 1992, that was responsible for British Columbia and the Yukon.
That was a major time, as you well know, in the history of transfusion medicine, and thus my work during those years was part of the broad topic of the Krever commission. What I would say to you, honourable senators, is that the shadow and the light of the Krever commission were a major contextual factor in the work of our committee.
Our conclusions were based on a vast range of conclusive data and on the thoughts and information provided by a large number of people representing patients’ groups, health professionals, decision makers, Canadian and international blood providers, manufacturers and plasma collection organizations from all over the world.
I think you all have had the opportunity to review our report, and I thought I would touch on a few of the major conclusions as it speaks to the bill that you are considering.
As I said, the Krever commission was extremely important. It has a critical history for those of us in the field of transfusion medicine and blood and for the patients and providers and their families who are involved in depending on these vital products.
Our report was mainly focused on intravenous immune globulin and other specialized immune globulins, but we also referenced many of the plasma-derived products that are part of the array of biological drugs that are available for patients in Canada. Demand for these products continues to increase, and for IG alone at 6 to 10 per cent a year in Canada, and this is a pattern reflected internationally.
Over the years, CBS and Héma-Québec have put in place many best practice strategies to protect our supply, and the issue of self-sufficiency is a topic that has been around in Canada since the 1970s, when I was the Deputy Medical Director of the Canadian Red Cross Transfusion Service for B.C. and the Yukon, we were all working across this country for plasma self-sufficiency to meet many of the needs that you have heard articulated during your proceedings.
Our panel that did the report spent a lot of time on patterns of utilization of these products, and, in particular, immune globulin. You have heard from a number of presenters that Canada is a high utilizer of immune globulin, and we don’t have a good explanation for that. We know that with proper guidelines and a robust structure to manage utilization that we could take a step towards plasma self-sufficiency without collecting any more plasma because we know we could reduce our use and still keep our patients very safe.
It is not an easy thing to do. It requires a lot of effort, structure and a national interest to do that work. I’m sure that will come up in our discussions after.
Canada was only able to supply, at the time of our report, about 17 per cent of the plasma needed to produce the products used by Canadians.
The vast majority of those products are sourced from plasma collected in the United States.
You have seen a number of these figures. Seventy-four per cent of source plasma, which is plasma obtained by plasmapheresis, from single plasma donors is collected in the United States. The rest is collected in other parts of the world.
Eighty per cent of source plasma is from compensated donors. This is where there is tension in terms of the whole issue of plasma and plasma-derived products. The issue is that they are required but that for decades there are extremely few countries in the world that have been able to achieve self-sufficiency using the best practice of a voluntary blood donor.
It is extremely difficult, and I think you will hear from my colleagues from Héma-Québec and CBS that they have experience and planned activity to try and achieve the goal of helping Canada become more self-sufficient with volunteer donor plasma through source donation, but it is a challenge. We know it is significantly more expensive.
You will see in our report that based on our discussions with CBS and Héma-Québec, and with international blood operators, it’s in the range of two to four times more expensive per litre of plasma to collect it from volunteer donors. We can get into the many reasons behind that.
It’s also important to remember, as you know and heard, that we actually have commercial plasma collectors in this country. The Prometic operation in Winnipeg is a long-standing operation that has collected specialized plasma from donors with specific antibodies, and that has been going on since the 1960s, where it started as a non-profit operation by Dr. John Bowman. It has been through a number of corporate changes and is now part of the private sector. They have used compensated donors for many years and I think you know that Justice Krever recognized that and felt their operation was safe and that there were no issues.
I have heard and seen in the presentations to your committee that there remain concerns about the long-term safety of plasma that is collected from compensated donors. And when Justice Krever wrote his report, I would say that there is absolutely no question that there were issues on everyone’s part, in terms of the crisis of contamination of the blood supply in Canada. There were government issues, there were issues in our non-profit blood operation centres, the Red Cross, there were issues related to the private sector. There was no one sector that one could say was the cause of the crisis. It was a crisis of slow decision-making, poor decision-making and a reluctance to integrate the best evidence in a timely way into the practices of our blood operators. Having been part of that story and having had my work, among others, deconstructed on TV every night for a couple of years, it leaves one with a very good recognition of our responsibilities of both governors of public policy, elected officials, those of us running and with the governance responsibilities for our blood operators, it is a serious business. And I would say that things have changed significantly since Justice Krever tabled his report.
We know in the last 25 years, we have not transmitted an infection with a plasma-derived product in the world that we have been able to document. The regulation and the standard operating procedures of blood operators in this country and across the world, and the quality programs of the industry itself that fractionates and collects much of the plasma, has been significantly enhanced. And the inactivation activities that are undertaken sequentially in the preparation of these products were not in existence at the time we experienced our crisis. So it is a different world and I think we have to remember that and never forget the history of Krever but also recognize that major progress has been made.
Among those of us who are in the industry, the issue of whether or not a donor is compensated is now considered to be irrelevant; that the compensation of a donor is something that allows us to create the capacity that we need for plasma.
We have in our report, as you will see, we have documented that the nature —
The Chair: I will ask you to summarize, we need more time for questions.
Dr. Ballem: I will summarize by saying that this is a complex issue. Getting to self-sufficiency in Canada is very important, and it will be difficult and a lot of hard work. Our colleagues will say the legislation has the risk of propagating some of the mythology about plasma. I think there could be an opportunity in this country to take a more comprehensive look at a new approach to the legislative and regulatory framework for plasma self-sufficiency. I will rest there.
The Chair: Thank you. I know you will have the opportunity to expand on many of these questions and comments.
Dr. Marc Germain, Vice President, Medical Affairs and Innovation, Héma-Québec: Honourable senators, thank you very much for giving me the opportunity to share some thoughts and comments with you on behalf of Héma-Québec, the organization I represent, about the bill we are discussing. I would also like to take this opportunity to explain Héma-Québec’s strategy on the issue Dr. Ballem has just brilliantly explained, which is supply self-sufficiency for the plasma used in the preparation of therapeutic products.
First, with respect to the bill as such, I would like to briefly explain that in Quebec, blood and plasma collection is the exclusive responsibility of Héma-Québec. These activities are carried out in compliance with the laws and regulations that apply on our territory, particularly those of the Civil Code, whose section 25 stipulates that the transmission of any part of a person’s body or of a bodily substance must be done free of charge.
In other words, in Quebec at this time, charging for blood or plasma donations is prohibited, so the passage of the bill would have no immediate impact in Quebec with regard to collecting blood products. Dr. Ballem explained this well and I don’t want to go into detail, but I repeat that I think it’s important to remember that plasma is collected to produce certain therapeutic proteins including immune globulin. This is at the heart of our discussions today. These proteins are derived from human plasma. They are essential to maintaining the health of patients, and in some cases it is even a matter of survival. Patients need these products to live a normal life and hope to survive their disease.
Héma-Québec, in addition to providing labile blood products to hospitals, that is to say packed red blood cells, platelets and plasma for transfusions, is also responsible for supplying the province with plasma-derived products, which are also called stable products.
All of the plasma we obtain free of charge from Quebec donors is used to prepare these products, when not used for patient transfusions. All of the plasma-derived products collected from Quebec donors are transfused and made available to Quebec patients.
Several years ago our enterprise launched an ambitious program to increase the quantity of plasma collected from its volunteer donors. Between 2013 and 2017, for example, the program was such a success that we were able to double the quantity of plasma collected in Quebec, which went from 50,000 to 100,000 litres a year.
This was made possible through significant investments in collection centres in several regions of the province, and through an increase of this type of collection in existing centres. Why did we make these efforts? As you heard from Dr. Ballem, the need for immune globulin throughout Canada — and the situation is the same in Quebec — is vastly superior to our capacity to provide these products from the plasma collected from Canadian donors.
Consequently, a large proportion of these products are obtained from paid donors in the United States. This great dependency on the American market for fractionation plasma presents a risk for the safety of patients and our supply. I think that everyone will agree that we have to aim to reduce this dependency, and this is recommended in the report mentioned by Dr. Ballem. I am going to quote an excerpt from the report, and it is in keeping with what we were saying earlier: patients who receive immune globulin can be divided into two groups, those whose life literally depends on those products, and those whose disease can be treated thanks to the use of these products, but for whom there are other therapeutic solutions. That is an important point.
With these considerations in mind, Héma-Québec set as its objective having a supply of plasma collected in Quebec to cover the needs of those patients whose survival depends on those products, that is to say, the patients who are suffering from conditions known as primary or secondary immunodeficiencies. They require approximately 30 per cent of the overall demand for immune globulin in Quebec and Canada.
Thanks to our efforts of the past few years, the increase in plasma collection from Quebec donors allowed us to increase our self-sufficiency. Barely a few years ago, we were at 15 per cent, and before that, at about 12 per cent. We have now reached 21 per cent, and we are on track to reach our 30 per cent objective.
I will go over the next point quickly, because Dr. Ballem explained it well. You will understand that at 30 per cent, we are still very dependent on plasma products obtained from paid donors, mostly American donors. Once again, I think this was very well explained, and we subscribe entirely to that interpretation of the scientific data.
Plasma products from paid donors are just as safe as products obtained from volunteer donors. The safety argument should not be used to justify the bill we are discussing now.
Incidentally, the bill mentions an exception for rare phenotype centres. We respectfully submit that the wording lacks precision and could be subject to interpretation. For instance, we could say that type O red blood cells are rare, and that is true. Only 7 per cent of the population has type O blood, and there is a great need for this type of blood. Does the bill want to make that type of situation an exception? We don’t think so. The wording might need to be clarified.
In closing, it is clear that giving blood free of charge represents a noble and commendable objective our organization fully supports. Efforts should continue to increase the level of our plasma supply self-sufficency from unpaid Canadian donors, ideally. Héma-Québec’s experience over the past few years shows that such efforts can be successful.
From a pragmatic point of view, it is not inconceivable that in the near future we may reach a level of self-sufficiency that will be higher than our target of 30 per cent; this would be advisable and perhaps even necessary. It could be needed, for instance, if there were a global shortage. There have been such situations in the past. Nothing points to such a shortage at this time, but as Dr. Ballem said, there is a constant increase in demand worldwide, and nothing leads us to think that this will decline in the near future. If we want to go beyond our current 30% objective, we may need to put in place other incentives to convince potential donors to give plasma.
I will again quote Dr. Ballem’s report which says that:
[...] the only jurisdictions that have achieved 100% self-sufficiency for plasma collection are those that have permitted paid plasma donors.
Given that context, a discussion on the remuneration of plasma donors appears entirely relevant, and related to the efforts made throughout Canada to attain self-sufficiency for fractionation plasma.
Thank you. I look forward to your questions.
Dr. Graham D. Sher, Chief Executive Officer, Canadian Blood Services: Thank you, Madam Chair and senators. I am pleased to be here at the request of the committee as you deliberate on this important issue of remunerating donors as a matter of public policy. Like my colleagues, I value the opportunity to report to you on the global risk of plasma sufficiency and the actions being undertaken by our organization, Canadian Blood Services, to address this risk.
We have embarked on a step-wise, cost-effective growth strategy for collection of source plasma in Canada through a voluntary non-remunerated model. This model is aligned with the legislation you are reviewing and with similar legislation in Ontario, Alberta and B.C. We are grateful for the flexibility accorded to Canadian Blood Services through exemptions in the legislation to monitor and react to the plasma sufficiency risks as stewards of the blood system in this country.
Canadian Blood Services was created in 1998 through a memorandum of understanding among the federal, provincial and territorial governments, following the Krever inquiry into the contaminated blood crisis. As the blood authority across Canada, with the exception of Quebec, we are a health products and services provider, accountable to provincial and territorial ministers of health for ensuring the safety and security of the supply of blood and blood products, including plasma.
In the agreement that founded Canadian Blood Services, the ministers adopted principles to govern the blood system: safety of the blood system must be paramount; voluntary donations should be maintained and protected; national self-sufficiency in blood and plasma collections should be encouraged; adequacy and security of supply of all needed blood, platelets and plasma for Canadians should be encouraged; and a national blood system should be maintained.
They further held in this agreement that the national blood authority shall be responsible for managing all aspects of the system: donor recruitment; whole-blood and plasma collection; and testing, storage, distribution and inventory management in a fully integrated fashion.
With respect to plasma, we collect from volunteers, unpaid donors in Canada for two purposes: to meet the transfusion needs of patients in hospitals and to ship the plasma to fractionators who then turn that plasma into biological therapies called plasma protein products, or PPPs.
Today, the focus of this bill and your deliberations is one type of plasma product, immune globulin, or IG, and the concept of plasma sufficiency to ensure sufficient IG for patients.
Sufficiency refers to the percentage of Canada’s IG needs that are met by the amount of plasma we are able to collect in this country. CBS is responsible for ensuring an appropriate level of sufficiency to meet the patients we serve. The salient point for today and the debate you’ve been having is this: Where is that sufficiency? It is dropping. Currently in Canada, excluding Quebec, that sufficiency is at 14 per cent. That means 86 per cent of the IG needs for Canadian patients comes from our purchasing immune globulin drugs on the global market.
To be clear, we are not alone in this. Countries around the world buy these drugs on the commercial market as part of ensuring lifesaving access to drugs for patients.
We know we need to collect more plasma. The current sufficiency level is now beyond our risk tolerance.
To this end, we have been alerting federal, provincial and territorial governments for five years to the emerging risks of global security of supply. Health Canada’s response was to establish an expert panel that Dr. Ballem chaired in 2017, as you just heard about. We worked with the panel by providing numerous documents and speaking to the issues at hand. We found some of the panel’s findings, including the main ones — that Canada must collect more plasma and reduce its dependence on the United States, and that Canada must act to mitigate the risk of IG shortages — to be aligned with the facts that we have been assessing.
We found several of the panel’s findings to be problematic or incomplete, and not fully reflective of the available evidence. The findings of the report that were not aligned with our information included: no urgency to act, despite the long ramp-up time to do so; no evidence that the U.S. plasma market is reaching capacity or saturation; that better IG utilization can address the sufficiency in meaningful ways; and no concerns around the crowding-out phenomenon.
We can all agree, however, that the situation is evolving, with new information coming from world forums as we speak. Internationally, there is a recurrent concern being played out that the U.S. commercial plasma market is at risk of reaching capacity. Even the largest commercial collectors in the United States are urging all countries to collect more plasma.
At the January 2019 European Directorate for the Quality of Medicines and Plasma Sufficiency Symposium — and again validated this week in Amsterdam at the International Plasma Protein Congress — countries have been speaking about the growing risk of dependence on the United States’ plasma market. Numerous countries are reporting supply tensions, instability or insufficient supply to meet their needs at times, including the U.K., France, Netherlands, Romania, Cyprus, Greece, Hungary, Latvia, Poland and Lithuania.
The question then is not if we will see product shortages but when. It is not a question of if commercial prices will go up but by how much. The time to act is now to protect the critical supply for Canadian patients.
So what are we doing about it? We have been maximizing the amount of plasma we collect within our existing infrastructure, and we are implementing a dedicated source-plasma collection program, starting with three plasma collection centres beginning this fiscal year 2019-20.
Since we first identified the risk, our business plans have evolved substantially. We have learned a great deal from international plasma collection industry expertise and from partner organizations in Australia, Quebec and the Netherlands. Recognizing the complexity, as mentioned by Dr. Ballem, we are implementing a model of source-plasma collection that harnesses the best of both worlds. It will draw on our own and others’ experience with non-remunerated donor recruitment and it leverages expertise from the large-scale, seasoned plasma-collection sector. This will ensure our operations are cost effective, efficient and price proximate to the commercial plasma market and result in a balanced security of supply and risk diversification by achieving a 50 per cent sufficiency level for Canada.
Finally, I would like to address the issue of commercial plasma collection in Canada. We have always maintained that, in Canada, a small collection operation or two can likely co-exist with the national blood system. It is the emergence of large scale, commercial for-profit plasma collectors that is and remains a concern. This must be considered carefully and responsibly by both CBS and health system leaders as to consequences and impacts. This includes the discussion around the ability of the not-for-profit blood industry to meet its collection targets in the face of the rapid expansion of the paid for-profit plasma industry. Most significantly for Canada, ceding control of donated plasma to commercial for-profit businesses does not mitigate the domestic security of supply concern.
The vast majority of the world’s plasma collection is vertically integrated with the fractionation industry. It serves a global supply chain and does not ensure domestic security of supply. Even if a commercial collector were under contract to CBS, they could redirect their collected plasma to other buyers at the end of the contract term. They are not bound to keep plasma collected from Canadian donors in Canada and they are not accountable to governments, health systems and patients as we are under our prescribed mandate.
This is the system expressly designed by FPT Ministers of Health which again stressed that a national blood system should be maintained and that the national blood authority is accountable and responsible for managing all aspects of that system in a fully integrated fashion. This includes a systems-level approach about when, where and how to collect blood and plasma to meet the needs of Canadian patients now and into the future, and in a way that doesn’t impact or damage either program.
Thank you. I would be happy to take questions.
The Chair: Let’s begin with questions from our deputy chair.
Senator Seidman: Thank you all very much for your valuable testimony today as we struggle with this piece of legislation. I would like to start with you, Dr. Germain, because I think you offered us a myth-busting statement. Although we’ve heard it before, from other witnesses, I think it is important, to pay attention to what you said, to reinforce testimony we heard before. That is, as you said, products derived from paid donors are just as safe as products from voluntary donors. You said it is not a safety issue but a potential shortage or sufficiency issue. Perhaps you, Dr. Sher, have said the same.
Dr. Sher: I completely agree.
Senator Seidman: We need to be clear on that. We have heard testimony talking about safety issues and that paid, remunerated blood is not safe. That’s where we would see pathogens appear and we would be more likely to incur infections in the population. I think we need to be really clear about the safety issue. I’m pleased to find that it’s reiterated.
Dr. Germain, we know Quebec supported Green Cross to establish a fractionation plant which will open in 2020. The facility will supply and export their plasma-derived products to local and international markets, if I understand correctly, including to the U.S. and China, while also establishing a local source for customers. Since Quebec prohibits the compensation of plasma donors, this facility will be bringing in plasma from the U.S., I believe. Héma-Québec has agreed to purchase IG products manufactured by this facility.
If we can’t justify compensating plasma donations here, in Canada, in Quebec, how can we continue to buy plasma from the United States, who compensate their donors? That’s the kind of hypocrisy argument that you’ve heard. If you could help us with that, I’d appreciate it.
Dr. Germain: From the strictly legal point of view, the Quebec Civil Code forbids us to pay Quebec donors, as an agency that has the exclusive right to collect plasma and blood. However, the law does not forbid us from purchasing products obtained or made elsewhere than in Quebec with plasma obtained from paid donors. So, from a strictly legal point of view, there is no contradiction. I totally agree with what you said about the fact that there may be a double standard with regard to the rules that apply in meeting the needs of Quebec patients.
I will go back to the fundamental argument, which is safety; the products are equally safe and effective. So, this is not an issue for the patients who receive them. However, it does raise the matter of the double standard, as you pointed out, with respect to the rules regarding the collection of blood and plasma.
Ideally, as I said in my presentation, I think we would all like to see 100 per cent of blood products and plasma collected free of charge. From a purely pragmatic point of view, that is not possible at this time, and it may not be possible internationally for several years. This issue is not limited to Quebec or Canada. I think it’s a reality we have to deal with.
Senator Seidman: I have a different question for you, Dr. Sher, if I might. You might want to respond as well.
We heard from the Chief Executive Officer of Canadian Plasma Resources who said:
Much has been made about the fact that our plasma is not benefiting 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.
Why is that the case? How you would explain that?
Dr. Sher: Thank you, senator. Part of it goes to what I said in my remarks. Assigning control of the plasma collection to a commercial for-profit collector who is free to sell their plasma anywhere in the world does not offer long-term sustainability of security of supply. It can only last as long as a contract can last. In our discussions with Canadian Plasma Resources, we saw no significant value in addressing domestic security of supply by purchasing their plasma. This is not a judgment on the safety issue. They are a regulated enterprise by Health Canada.
The issue for us is we are seeking to grow the donor base in a non-remunerated model. That is the model that adheres to the principles and the mandate under which Canadian Blood Services operates. We don’t buy any plasma from the remunerated plasma market. We buy finished products, which gets to your question to Dr. Germain to which I can add some additional colour commentary.
For us, this is about addressing a long-term security of supply concern. Canadian Plasma Resources has limited volumes in very limited markets and does not offer domestic security of supply. That’s the premise under which we chose not to purchase their plasma.
Senator Seidman: I would like you to respond to my other question also.
Dr. Sher: I thought your question on the hypocrisy argument is a really important one. We have heard this many times. I would go further than Dr. Germain and say this is not a double standard. We don’t even see this as a double standard. If one believes — as we all do; you have recognized this yourself — that the paid plasma issue is not a safety issue, then we are not offering any judgment over one set of products being safer than another. What we are seeking to do is to achieve risk diversification in the market. We believe that risk is best diversified if some of the raw material is acquired domestically, and some of the finished product is acquired internationally. The fact that the finished product internationally comes from paid donors, as Dr. Ballem said, is not the issue we are concerned about. What we don’t want to do — what we believe is a risky strategy — is a 100 per cent self-sufficiency strategy in this country. First, we don’t think we can get there in a non-remunerated model; and, two, the United Kingdom was in that boat and then mad cow — vCJD — hit and they couldn’t do anything with their plasma.
For us, it is not hypocritical. It is smart risk diversification. We’ll collect sufficient plasma in this country to meet domestic needs for the patients who need it — our calculation is closer to 50 per cent, but that’s sort of not material — and buy the rest of the product on the commercial market. We’ll mitigate risk that way, and we don’t believe there is any hypocrisy in that.
Senator Ravalia: My first question is for Dr. Ballem. You alluded to the appropriate use of plasma-derived products, and perhaps in Canada we may be over-utilizing it, and this may be based on evidence-based guidelines et cetera. Do you have any evidence from international sources where there may be a more prudent use of these agents, and could we transcribe these practices into the Canadian medical practice?
Dr. Ballem: Thank you for your question senator. The panel did a lot of work looking at utilization. We are the second-highest per capita user of intravenous gamma globulin in the world, second to the United States, and we are significantly beyond many other countries in the G8.
There are a number of different utilization management programs across the country. Our problem in Canada is that we have no one guideline for the country. Every province has created its own guidelines. What we also know is that the implementation of those guidelines and the adherence to these is very difficult to manage.
In our conversations with the transfusion medicine experts who are basically charged with managing utilization, they expressed that it is extremely difficult for them to manage their colleagues in neurology, rheumatology, internal medicine and pediatrics, who all have a different opinion on things.
The most robust structure is in the U.K., and theirs came from what Dr. Sher referenced. They had a major crisis of supply when their case of variant CJD hit them. They created a robust structure and an appeal panel, and they have a very good mechanism to ensure that utilization adheres to their guidelines, which are evidence-based, and that there are avenues for appeal if there are specific exceptional circumstances.
We could benefit from a program like that in Canada. It is definitely possible. It is unusual for this country with its different health systems across the provinces and territories to come together to work on a national program. We have two blood organizations, and I think it is definitely possible to enhance our utilization.
I would say, based on Dr. Sher’s comments that I don’t think that the panel ever envisaged that just utilization management would solve our problem. That’s not the case at all. But it will definitely make a significant contribution. To come to self-sufficiency is a multi-pronged effort. You have to collect more plasma. You have to utilize the products more judiciously. There are also small companies in Canada that are looking at technology in terms of manufacturing these biologics that have a much higher productivity than the traditional technology for fractionation. They can enhance productivity and the production of every unit of plasma by up to 20 per cent. That, too, will make a difference. The panel felt it is a multi-pronged effort we need. It’s a complex issue, there is no magic bullet and we have to look at all these different possibilities to work our way up the ladder of plasma productivity.
Senator Ravalia: Dr. Sher, you’ve repeatedly alluded to the long-term sustainability supply issue and the fact that we may, in the future be vulnerable to the U.S. in terms of its ability to supply us, potential for being held hostage, in a sense.
Would a compensated model of plasma collection in Canada not contribute in some way to assuring a safer supply for the country?
Dr. Sher: Senator, I think the issue is more fundamental than that, if I may. You are correct in your observation that we’ve been calling out concerns around the U.S. market reaching a saturation point at some point. We are not alone in calling it out. It is now the U.S. commercial plasma industry itself calling out that concern and urging every country to collect more.
As every country collects more, it mitigates the likelihood of global insufficiency of plasma to make this IG. We all need to do more. The question is: Can we do more in Canada in a non-remunerated model, or does it require a remunerated model, that we go there? You heard from Dr. Germain. They have been out of the starting block for several years now with success to show for it, growing from 15 to 21 per cent in a non-remunerated model. In Australia, they are at 55 per cent sufficiency in a non-remunerated model, with a target of 70 per cent. We have set ourselves a very ambitious target from a significantly low starting point, and our intention is not to remunerate donors. Can we get to that end state in a non-remunerated model? As Dr. Germain said, we will have to assess that as we go along.
We have to collect more plasma in this country. We have experience in recruiting donors in a non-remunerated environment. We are leveraging the expertise, the operating efficiency, of the commercial plasma sector to understand how they do their operations efficiently, but we don’t need to emulate their donor recruitment strategy, which is a remunerated strategy.
I think you are correct. Every country, and let’s focus for the most on Canada, needs to collect more plasma. That mitigates the global concern. We believe we can do it, at least initially, in a non-remunerated model, and that’s our strategic objective. I think we have those ahead of us — Quebec, Australia and others — to at least set the path. We are confident we can get there.
Senator Eaton: Just to continue with Senator Ravalia’s questions, Dr. Ballem, there is remuneration and then there is remuneration, and several countries who claim they have a voluntary system are sometimes offering quite generous incentives, such as one or two days off work.
So would you define what is remuneration, incentive — one or two days off work — a Visa card? I’m not giving you cash for your litre of blood, but, gee whiz, I will make sure that your employer sees it is as a health concern and that you get one or two days off work.
I think if we are to follow what Dr. Sher is saying, namely, no remuneration, we have to make sure there is no time off work, no Visa cards, no candies. You strictly walk in there as a volunteer and do it.
Would you respond to that? Just to follow up on the question, the expert panel found that it was two to four times more expensive to run a voluntary system than the commercial system. Perhaps you could tell me why, and, considering the demands for health care dollars, is this a good use of our resource system? I’m sorry; I don’t mean to burden you.
Dr. Ballem: Thank you so much, senator, for your questions. In regard to remuneration, compensation and incentives, it is a complex issue. I think the panel was surprised that even in the European Council countries, where there was standing legislation that donors cannot be remunerated, they are compensated. In some, there is also legislation to say there is a certain amount they can be paid as compensation for their time and effort. In fact, as you’ve cited, there is a whole range, a continuum, of different compensation that is given. It goes from one to two days off work in either the public or the private sector. It can be a stated amount that’s usually in the range of 30-50 euros, all the way down to gift cards. I think it’s fair to say that most blood donors appreciate a refreshment when they come in to make a donation.
So as we noted in our report, the standard of what is a true voluntary donor is changing; there is no doubt about it. At the time we were discussing these issues, the national blood system of the Netherlands, which has had a long-standing goal of voluntary donation, was musing on the fact that they felt that they may need to have some more incentives to attract not only plasma donors but also blood donors.
The world is changing. Our generations are shifting, and I am very happy to hear Dr. Sher feel confident that he is going to reach his goal of 50 per cent self-sufficiency.
I would say from the panel’s perspective, the experience around the world says that it is going to be a very challenging run for Canada. When you look at the history in Canada of self-sufficiency, we’ve talked about it and set goals for ourselves since the 1970s. In our report you can read the different commitments made, both by CBS and Héma-Québec, which had to be revised even over the last 20 years.
It is very challenging. The evidence is very clear: If you can compensate to some degree, it has shown that you can enhance collection.
I think the issue that we’re talking about is: Who will make those decisions? As Dr. Sher has referenced, is it a proper principle that any plasma collected in this country should be returned to this country in the form of products for our populace? That, in some ways, is the fundamental question.
In our panel report, the panel mused on that and said there are probably mechanisms and ways that we could create that requirement, that when you collect plasma in Canada, it either has to be sold to the CBS and Héma-Québec in a reasonable business case, or there has to be mechanisms whereby you show that that plasma does come back to serve the needs of Canadians.
All of these things are fraught with double standards and “is that really fair,” but what we are trying to do is use a tool of compensation to actually achieve the principles of the way forward in ensuring that enough plasma is collected in this country and that it is brought back in the form of biologic products to serve the interests of Canadians.
I think the panel’s feeling is that this is not an issue of compensation. Compensation is an enabler, it appears, internationally of the journey to become more self-sufficient and make a better contribution to the manufacture of the drugs that we need.
The real question is: What is the best way to ensure we achieve that? I believe it is a very complex issue, and the simple fact of saying you can’t compensate a donor — it’s true that both the fractionation industry and blood operators are all saying we must become more self-sufficient. We cannot all depend on the United States.
Senator Eaton: The U.S. does compensate their donors.
Dr. Ballem: They do. They supply 75 per cent of all the source plasma, and 80 per cent of that is from compensated donors. It is a fact.
It’s difficult to understand that we could be successful. It will be a lot of work. I think the provinces and territories, which are responsible for funding this system, are worried about the value for money.
As Dr. Sher has pointed out, it will take some time to prove that we actually could get it. I think that Héma-Québec has done a good job showing what can be achieved, but we have gone from 15 to 21 per cent in four to six years. It is a slow journey, and we will not get there overnight, no matter what we do with our donors. I think it’s pragmatism that we need to consider.
Senator Eaton: Thank you.
The Chair: Dr. Sher, did you want to add something briefly?
Dr. Sher: Yes, Madam Chair, just further to Senator Eaton’s question.
I agree with Dr. Ballem. This is an inordinately complex issue. Our view is that there is an opportunity to leverage our experience in non-remuneration and leverage the operating efficiency of the commercial sector to start the model. I don’t think that it requires, in Canada, that we get out of the starting blocks by remunerating donors. We have certainly worked with —
Senator Eaton: — remunerating donors. There are several ways of remunerating donors. You mean not giving them anything but a glass of water.
Dr. Sher: We give our donors certificates and pins for every milestone. There is a spectrum, as Dr. Ballem said, of incentives through to —
Senator Eaton: That is a form of remuneration.
Dr. Sher: Giving someone a pin for every twentieth donation, I think the ethicists are clear —
Senator Eaton: That’s fine.
Dr. Sher: We believe we can do it in a non-remunerated model to start. That is the challenge we have to rise to.
I have one important point I want to stress that Dr. Ballem has raised that is correct. We need to demonstrate we can do this in a cost-effective model. This is not about collecting plasma at any cost. We are responsible stewards of the fiscal funds.
Our commitment to our funding governments is that this model will be tried and tested to demonstrate that we collect a litre of plasma at a proximate price to what the commercial for-profit industry is doing. That’s what we have to demonstrate. If we can’t, we have to have all other policy options on the table, one of which could be remuneration of donors.
Senator Oh: I want to go back to the IG products. Could you explain why the demand for IG has been increasing in recent years? What is the cause? Do you expect demand to keep increasing?
Dr. Ballem: Thank you, senator. The demand for IG has increased because there are — it is what we call a biologic modifier when you move beyond replacing antibodies. It’s used for people with immunodeficiency, which is a fairly circumscribed group of patients. The real growth in use has been its use as a biologic modifier, where it actually makes an adjustment to the immune system of a patient and can be used to treat a whole variety of autoimmune diseases.
The biggest growth has been in the neurologic sector, where we are using it for a number of conditions that are complex neurologic conditions where you have degeneration of the brain and the peripheral nervous system, and it is based on the body attacking itself. Intravenous gamma globulin in large doses can actually impact the history of those conditions.
So it has grown from being a product, when I was in my early years of practising, that was used by hematologists for specific issues like ITP and immunodeficiency. It has broadened into rheumatology, neurology, more extensive paediatric uses.
There are always researchers on the lookout for other uses. Really, that’s why the growth continues to rise.
The other issues are that in many countries around the world — and this is a concern in terms of what will happen — as you look at countries like Indonesia, Philippines, China, Southeast Asia, where the public has not had access to universal health care, as we do, in many of our developed countries, as their economies continue to grow and there are more expectations from their public for treatment, they will create demand for some of the very basic indications that we’ve been treating for many years.
Global demand is growing for that reason and also because the indications are growing.
Senator Oh: Does it have something to do with cancer? Are more people getting cancer and needing cancer treatments that use this?
Dr. Ballem: There are some kinds of cancer where the immune globulin is used, where the immune system is diminished by the cancer. Those are long-standing indications. Those are most of the secondary immunodeficiencies that we have referenced as an indication for treatment.
I would say that the vast majority of growth is in the non-cancer areas of degenerative diseases.
Senator Oh: I visited your clinic, and I can’t remember seeing any signs about the collection of plasma or anything. Is there any special promotion that you’re doing so people will come and donate?
Dr. Sher: Senator, firstly, thank you for the visit. I recall your being there.
That particular centre does not collect plasma. What we collect in that centre is what we call whole blood, essentially a pint of blood from a donor. What we do, though, is we take that pint of blood back to our manufacturing facility, and we separate it out. We get red blood cells, which are mostly used for trauma and surgery patients. We can get platelets, which are used for bleeding patients.
We then take the plasma from that pint — we call it recovered plasma — and that does go towards our fractionation pool. That’s how we get about 200,000 litres of plasma, currently, every year.
While I say we don’t collect plasma in that facility, we recover the plasma from every pint of blood we collect.
What we are talking about here, and following the Quebec model and others, is building stand-alone dedicated plasma centres where all we will do is hook donors up to special machines that collect only the plasma, not red blood cells. That’s why you can collect more often from those donors, in much bigger volumes.
Senator Oh: Are these donors coming back every time just for the particular donation?
Dr. Sher: Currently, we have donors, for example, in Toronto who come only for blood donation. In many of our other centres across the country we have donors who come specifically for platelet donations and we do have some donors who come for plasma donation as well, but at the moment it’s in small numbers.
Senator Oh: If I want to come for a plasma donation, how do I do it?
Dr. Sher: You go on Blood.ca, and you’ll see various locations across the country where we do plasma donations today. That’s the opportunity we’re seeking to expand, senators, by building more of those plasma centres.
Dr. Germain: If you want to donate today, you can go to our plasma centre in Gatineau. It’s very close by.
Senator Mégie: I have a very down-to-earth question. What happens now when you need blood for a patient with a rare phenotype?
Dr. Germain: That would, of course, not be plasma. For rare phenotype blood, we are talking about red blood cells. That is a whole other issue. There is the matter of the diversity of donors who give blood, and in that connection we collect whole blood and not blood plasma. With regard to the plasma that is used for the preparation of plasma-derived products, there is no need to look for genetic diversity in order to obtain a broader range of possible phenotypes. It’s more a matter of red blood cells.
Senator Mégie: Why does the bill—since we are talking about plasma and blood-derived products—say that CBS is the only organization that can collect plasma or blood, except for rare phenotype donors who should be paid? If I understand correctly, this should not be in the bill.
Dr. Germain: Senator, I can’t speak for those who drafted the bill. I mentioned that we feel the current wording is not precise because in our jargon when we talk about rare phenotypes, we are referring to what you spoke of—red blood cells for communities who have trouble finding an appropriate phenotype for their medical condition. I think the intent of the bill is to create an exception for existing plasma collection centres which collect plasma that is used to prepare very specific products, products to immunize pregnant women against the RH factor. These programs already exist and the donors are not remunerated. We are talking about rare blood, because we have to recruit donors with high levels of antibodies, and blood has to be collected often. You will have to ask those who drafted the bill, but I think that is the exception they had in mind. Once again, I will just say that the current wording may lack some precision.
Senator Mégie: I’m beginning to wonder about the usefulness of the bill, because if we vote against it, things will remain as they are, it will be the status quo. If we vote for the bill, the provinces that have already prohibited paid donations will be federal outlaws, even if they have the power to do so, like Quebec.
So this will affect the provinces that have not yet forbidden it, and have allowed it. What will be the impact on provinces like Ontario, Quebec and the others who have forbidden it if we vote for the bill? Will there be impacts? Will they have to change their position, or simply ask that we respect their decision?
Dr. Germain: First, as I mentioned in my introduction, in Quebec, the remuneration of donors is already prohibited, and so the federal bill, should it pass, will not change anything. With regard to the other provinces, I would prefer not to comment.
Dr. Sher: I will comment on that, senator, given that we operate across all the other provinces and this has been a contentious issue among the member governments that are the members of Canadian Blood Services. B.C., Alberta and Ontario have the legislation, as you have acknowledged. The other jurisdictions do not and, in two of those — Saskatchewan and New Brunswick — they have actually permitted the existence of a new paid plasma collector. So that has been a significant issue of contention among our member governments, to whom we are accountable.
What we’re concerned about with the federal legislation is that nothing should emerge in this legislation, were it to pass, that would impact our ability to operate. As we see it now with the exemptions that are being discussed, we’re content that it doesn’t impact our ability to operate. That’s most important for us.
Were this legislation to pass, I can’t speak for the governments of Saskatchewan or New Brunswick. That would be a federal-provincial discussion to be had, but it will amplify some of the issues we have dealing with our funding governments, where there are currently different perspectives among the jurisdictions that comprise Canadian Blood Services. I don’t think it will not be without impact. I think that’s important. From my organization’s perspective, were this federal legislation to pass, we would want all assurances — and I think we have sought and achieved those thus far — that the bill will not impact on our ability to operate, now or into the future. This is why this issue of potential exemptions is so important.
Senator Mégie: Thank you.
Senator Forest-Niesing: Thank you for being here and for helping us to understand the bill, which, in spite of being very short, has repercussions that have given us a lot of food for thought. I was listening to you, Dr. Germain, and you said that your objective is 30% for the first group of patients who depend on these products for their survival, and that this objective, according to your calculations, corresponds to the needs of Quebec patients.
I would be interested in Dr. Ballem or Dr. Sher’s comments with regard to the percentage. If I understood correctly, your objective is 50%, and you hope to reach it by 2024. How did you arrive at that percentage, and does the analysis correspond to the needs identified for the patients whose survival depends on the use of these blood products?
Dr. Sher: Thank you, senator. We took a similar approach and what you heard from Dr. Germain is that their target of 30 per cent is based on essentially meeting the needs of patients with primary immune deficiency and secondary immune deficiency, those for whom this is a life-saving therapy without any alternative. That is certainly one approach.
What you heard from Dr. Ballem a couple of minutes ago in response to Senator Oh’s question around growth is that there are other indications for which this is an essential therapy. The big one in the neurological condition is a disease that goes by the acronym of CIDP, an important neurological condition for which IG is currently shown to be the best therapy by far. We added that into our calculation and, as Dr. Ballem said, it’s probably the single fastest growing indication for IG.
If you take the immune deficiency categories and some of the other critical categories for which the clinician, we serve are telling us it’s an important therapy they need access to, we’re saying that, at a minimum, we need to protect that share of the market. So you add the immune deficiency markets and the neurological condition and we come out around 50 per cent sufficiency. That’s how we arrive at that.
Our view is that the road to 50 per cent goes through 30, 40 and 45, so let’s evaluate as the country moves along, which will be a multi-year program. We need to constantly reevaluate. Maybe clinical practice will change in some years and we will need to have flexibility to scale up or down. Is the 50 per cent carved in stone? No. But directionally, we believe it’s the right balance of risk and security of supply that we should aspire to in this country.
Senator Forest-Niesing: Given that the road is long — we all agree on that — and given some of the testimony that we’ve heard from patient groups who express a serious concern about the impact, and if this law passes, the impact will be to essentially prevent the provincial facilities that already exist in Canada from continuing to operate. That is a conclusion at least that one can arrive at.
Given that, I’m concerned about the lapse, and how can we comfort or alleviate the concerns of patients whose lives or ability to live a quasi-normal life, despite an illness, is jeopardized in that period as we trudge along this long road?
Dr. Sher: That’s a fundamentally important question, senator, and I’m sure my colleagues can offer additional perspectives. As I said in my remarks, we have been calling out this concern for several years precisely because the duration to act is so long. We can’t wake up in 2023 and realize there is a shortage of IG and not have the capacity to respond. We need to respond. We should have been responding already. That’s an important point.
I’ve read the testimony of some of the patient groups — Ms. Whitney Goulstone and Mr. David Page. We know those stakeholders extremely well. We work closely with them all the time. They expressed concern to you that this legislation should be killed; it will be detrimental to patients.
We don’t quite take that interpretation, but I think our assurance to the patient groups is the following — and I will speak for Canadian Blood Services; Marc can speak for Héma-Québec — our commitment is to ensure, for patients in this country, that there will be access to IG therapy at all times. We believe that in order to do that we need to mitigate the risk that we’re now facing. The risk that we’re facing is dependence on the commercial market in the United States.
It is not about whether we pay or don’t pay donors; it’s how we collect more plasma in this country, and that’s how we deliver to the patients an assurance we can meet their needs. That’s why our model is focused on achieving 50 per cent sufficiency.
It is also why our model leverages the best of both worlds. Our experience in working with non-remunerated donors, and learning from the commercial sector about their operating efficiency, namely how they operate as efficiently and quickly as they do?
If we can apply those two learnings from that sector and our experience from non-remunerated donors, we will have a model that will allow us to go up this trajectory as quickly as possible in a cost-responsible manner, But it can’t be solved overnight. That’s the problem. We have been saying that for several years.
Dr. Ballem: It raises another issue. Dr. Sher has outlined how they have said immunodeficiencies and the neurological disorder is the fastest-growing area. In Canada we don’t have an agreement on the priorities. Should we have a shortage? How would we dispense the available immune globulin? It is a critical priority that we have a discussion that is evidence-based with the expert clinicians around the country and come to agreement on what the priorities would be.
In some ways, those will dictate the priorities of the advances we make in self-sufficiency in terms of calculating them. I wanted to put a plug in for that. It’s a gap in our system. It could be easily solved with very little resources are required. I would say it’s also quite urgent.
Senator Munson: Thank you for being here. I like to keep things simple. There are a lot of complex questions, and we heard a lot of complex answers. We’re sitting here; you’re sitting there. When you first saw this bill appear, what was your immediate reaction to it? Did you think it was necessary?
I’m sure Senator Wallin has laudable goals in what she is trying to do — the whole idea of paying for something that’s part of our bodies. As everyone has said here, we have wrestled with this issue. It’s a difficult one, as simple as this bill is here today, and some groups have said kill it and others say that it has to stay out there because we need that supply.
From the three of you, when you instinctively saw this bill, what was your immediate reaction?
Dr. Germain: Senator, the simple and evasive reply to your question is that Héma-Québec’s reaction was completely neutral, because this isn’t an issue in Quebec right now, given the clause in the Civil Code. I have already shared my stronger reactions, aside from Héma-Québec’s particular issues.
The remuneration of blood donors is a complex and international issue. It is not a strictly Canadian issue. You have to look at it in a context that goes beyond Quebec and Canada and examine the international situation. We must be very cautious with regard to the means we take to attain greater self-sufficiency internationally. Everyone agrees on that.
I will, in passing, express support for what my colleague Dr. Sher said earlier regarding the fact that the international community recognizes that we must all make some efforts. One of the advantages of supporting the self-sufficiency project, whether the percentage is 30% or 50% in Canada, is to provide an example. We may not be at the back of the class internationally, but we are not at the head of the class either. It’s important to show our international colleagues that it is possible to increase self-sufficiency. This can only improve the situation at the international level, because other parties will be able to draw lessons from our actions. This is much more important than the matter of remuneration, which appears secondary to me for the reasons that have already been explained.
Dr. Sher: This was our fourth opportunity to have a reaction. We had it in Alberta, Ontario and British Columbia. We do not believe it is our organization’s role to tell governments how to legislate. That said, we needed to understand the scope and mandate of this bill. As I said earlier, would it have impacts on our ability to do what we need to do, which may potentially include some consideration of remuneration down the road? That was most important for us.
We needed to ensure that the fact base behind this legislation is accurate. That’s why we’ve been clear around the safety consideration. We ask the question: Is this within the mandate of the federal government and its oversight over the Food and Drugs Act? I’m not a legislator or lawyer, so I can’t opine on that.
For us, this is about ensuring that were this legislation to pass, it does not impede our organization’s ability to advance its strategy.
Dr. Ballem: Senator Munson, this act was brought in after the panel had deliberated and tabled its report. In formal conversations, for sure I would propose that it’s a very complex issue. This is a very simple piece of legislation, and it doesn’t reflect the complexity that you have heard today and with other presenters.
It runs the risk of doing some harm to existing operations that are already in this country, successfully producing important products. We would do better with a more thoughtful approach to our goal of self-sufficiency and how we will address the more critical issues of where the plasma that we collect in this country will go. We know that under the current regimes it will be safe whether we have a compensation of a donor or not. But it’s really how we do this in a cost-effective way achieve the goals that both Héma-Québec and CBS have laid out. It’s not the issue of compensation. It’s really the issue of the plasma market, who is in it, what is it we want for Canadians and how we bring our two Canadian blood operators to be successful in sustaining a supply.
Senator Munson: What it has done, though, is brought this into a public debate that we haven’t had for some time. No matter what the views are, there are people who hopefully are paying attention to what we’ve been listening to in the last month and a half or so on what may be a simple bill needing a bigger solution. Thank goodness we are reminded of Krever, where we should be going and what we should be doing. In some way there is some positivity that that debate is out there, which I think is taking place in all of your communities. Thank you.
Senator Poirier: I agree. Even if the bill is short and simple, it has been a complex issue and an educational one. During the process we’ve learned a lot and I’m sure anyone following the proceeding of the committee would also agree that we as Canadians have learned a lot about plasma donations over the time.
I have a couple of questions. A lot of them have been addressed or other people have brought up but I want to get back to the proposed bill. The proposed bill in proposed subsection (1.1) says:
An establishment, other than Canadian Blood Services, must not collect allogeneic blood for remuneration or benefit for the donor unless the blood collected is of a rare phenotype.
I know, from listening to the CBS position on this, your goal would be to be able to collect what we need without having to remunerate. If I’m understanding this, it also in the bill would give you the ability to be able and be the only group that could remunerate if ever you decide to at a future time. And I believe the Winnipeg organization, because of what they’re collecting, would be okay through this bill, but if I’m understanding right it would possibly affect the shutting of the New Brunswick one.
Can you please confirm if my thoughts are right on this? And would you in the future look at this as something that would give you the ability to maybe compensate with incentives of some type the people that would collect?
Dr. Sher: Your conclusions are correct, senator, and in line with our thinking. This goes back to what Justice Krever called payment in special or rare circumstances. That is what the Winnipeg facility has been doing for decades and we believe they would be granted that exemption under this legislation. So I’m not sure it would have the impact quite to the extent that Dr. Ballem describes but, again, it grants us the exemption should we ever decide from a policy position to go there. And you’ve heard from many other witnesses here, including some of the lawyers yesterday and some of the other groups, that if anyone ought to pay in this country it ought to be the public sector and Canadian Blood Services.
That is not our position. We’re building a non-remunerated model, but we have to reserve that right should this never achieve success any other way, and that’s the essence of how we read it now.
Senator Poirier: Because the Province of New Brunswick, or each of the provinces, has the ability in their own legislation to allow a company to come in — and New Brunswick has made the decision to allow it — I’m wondering that if this bill would be passed as is, does this mean that we’re closing the one in New Brunswick? There have been a lot of concerns about it. I have heard it over and over, and more in the beginning than lately. Where would the provincial law come in here? It’s the provincial legislation that gives the authority for the company to be in New Brunswick yet this legislation would say that they can’t. I’m questioning that and I’m sure none of you have the answer to that.
Dr. Sher: I can’t answer that.
Senator Poirier: That would be a question for the future.
In the documents provided to the committee it states that the CBS submitted a business plan to the federal-provincial-territorial governments which outlines the looming risk to the security of the plasma supply. Could you please give us more detail on that plan? Will you be collaborating with Héma-Québec, who has already an established plasma centre in the province? Is that part of the plan also? Could you highlight that?
Dr. Sher: We submitted a comprehensive business plan in 2017 to the provincial and territorial governments that looked at the soup-to-nuts solution, so building multiple centres across the country. The challenge we had at that time was that we were using our existing cost structure and our existing model. When Dr. Ballem and the panel observed correctly that the evidence before them suggested the non-remunerated public sector was going to operate at two to four times the private sector price, that was the observation based on our business plan. So we agree with that.
As I said in my remarks, we have subsequently gone back to the drawing board. We have collaborated not only with Héma-Québec but with colleagues in Australia, who had multiple up centres up and running, with colleagues in Netherlands and elsewhere, where they were doing likewise. We are seeking to leverage the learning and the expertise from the commercial sector. We really do believe that the three sites we’re now beginning to operate, starting this coming fiscal year, will demonstrate that we can collect a litre of plasma at what we’re calling a market proximate price essentially in line with the commercial price of plasma on the world market today. That’s what is most essential, because all funding governments don’t have limitless dollars. This cannot be done at any cost. We completely agree.
Senator Poirier: How long do you think it will take you to get your centres up and running?
Dr. Sher: We have committed these three sites to our provincial funding governments. Over the next three to five years, we will demonstrate the volume they can achieve and the cost at which they can achieve that, and if we can demonstrate that, we then believe it is a scalable model until we achieve the sufficiency level we need.
Senator Poirier: How long do you think it will take to get to that 50 per cent?
Dr. Sher: I think it was Senator Forest-Niesing who said earlier 2024. That was in the original business plan. It’s probably several years beyond that.
Senator Omidvar: One of the advantages of going at the very end is all the important questions have been asked and answered, so thank you very much for your presence.
I do have a question that has not yet been addressed. I think we all have learned through witness testimony and our study of the issue that this is a serious issue, but it is also an incredibly complex issue with serious consequences. I take your point that it’s not an issue of safety, although in preceding panels we have heard that it is an issue of safety. But we have heard from you that there is a pressing issue of security and supply, rising demand, life and death implications for patients whom we have heard with great attention. We also heard there are double standards. Senator Seidman asked you a question about moral ambiguity, maybe even moral hypocrisy at play here. There’s provincial dissonance, possibly.
Do you believe that a bill with such serious consequences and a bill of such complexity should be tabled in the House of Commons by the Minister of Health?
Dr. Ballem: Could you just clarify whether it would be better to be tabled by the Minister of Health?
Senator Omidvar: I’m asking you your opinion whether a bill with such complexity at heart and such far-reaching consequences for the health and safety of Canadians should be better tabled by the Minister of Health in the House of Commons?
Dr. Ballem: I would be in agreement that this is a very complex issue, as I’ve said, and the problem we are trying to solve is security of supply and Canada’s contribution to that on behalf of our own patients and it is complex. I think it requires more than a simple solution like this, so if it is in the purview of the Minister of Health that would make sense to me.
Dr. Sher: Senator, I don’t know enough about parliamentary protocol to say yes or no to that.
We have certainly worked closely with Health Canada, the minister’s office and the Department of Health, both when they established the panel and even on an ongoing basis, to ensure that the minister and her department understand the critical issue of security of supply in this country.
We have kept the department and the minister’s office very closely apprised of the evidence base that we are dealing with all the time, and the urgency for this country to act to collect more plasma.
Senator Omidvar: Dr. Germain and then back to you, Dr. Sher. Do you know if the legislation in Quebec, and in your case Ontario, Alberta and British Columbia, was tabled by the government, or was it a private bill tabled by an individual parliamentarian? It makes a real difference in terms of the robustness of the background work, the legislation, the language and the discussion.
Dr. Germain: I will answer you with reservations, because this is question touches on a matter that is beyond my competence. According to my understanding, the provision in the current Civil Code goes back to its adoption; I think that was in 1991, so long before the creation of Héma-Québec, and I don’t think it had anything to do with considerations around giving blood. It dealt with general considerations regarding the donation of a part of oneself in exchange for a fee, and when Héma-Québec was created, we had to become aware of this legislative reality in Quebec. However, this was not done in the context of a debate such as the one we are having today.
In passing, I wanted to comment on the point raised by Senator Poirier concerning the exception for for Canadian Blood Services and the exception for Héma-Québec in the bill. I think an amendment was tabled to include Héma-Québec in the exceptions to the non-remuneration rule. I think that is entirely appropriate. Even if the law in Quebec does not allow this at this time, this could change.
Senator Omidvar: I would like to get back to my question around the background of the legislation in the other jurisdictions.
Dr. Sher: In the other three jurisdictions, it was all passed by the government of the day.
Senator Omidvar: Thank you.
Senator Dasko: Dr. Sher, my question is about the methods by which you will increase self-sufficiency in a volunteer model to meet your goal of currently 14 per cent up to 50 per cent. So you talked about opening centres. In Quebec, how many centres are there?
Dr. Germain: We have opened four and this year there are two more. So it is six. Most of the centres are dedicated.
Senator Dasko: Dr. Sher, you talked about three Canadian centres. Is that the extent of effort that is supposed to be made to take us from 14 to 50?
Dr. Sher: Certainly not, senator. In order to get from where we are today to our anticipated 50 per cent sufficiency, we will need around 600,000 litres of plasma. The model would require around 30 centres, collecting 20,000 litres per centre per year. So the three are a demonstration that the model works; it works for non-remunerated donors and it works cost effectively. Once we can demonstrate that, there is a rapid scale-up beyond that.
Senator Dasko: Tell me how you will engage Canadians in this, especially in a volunteer model. How will they be encouraged to do this because you can’t just open centres?
Dr. Sher: That’s an excellent question. I will be brief in the interest of time. We recognize, and we have learned this from the Australians who have the greatest experience, and Quebec as well, that it takes about a year before you open your doors to have built the donor base in that city where your first centre goes.
We are already beginning the work now to build a committed donor base. It is a significant education activity. These are individuals who are committing multiple donations per year. You want a minimum of six, preferably eight or ten, donations per year. We have to create a donor experience that is attractive to somebody, and they want to come back and do this. These are the attributes of a voluntary system relying on donor experience. In a paid system, it is really more about the remuneration that brings them in.
We have a lot of experience with this in the blood environment. We open blood centres all the time, and it is about creating an environment that is attractive and experientially positive for the donor. Australia has very good case studies on this. We are certainly applying those learnings. Héma-Québec has some exceptional best practices, and that is what we will be doing. But you don’t just put an ad in the paper and expect the donors to be there the next day.
The only other point is no centre can go from zero to 100 per cent volume achievement in a year. It takes at least three years. So each centre, if we say 20,000 litres is our target, will take about three years to go from opening the doors to achieving that run rate. It takes a community activation and a sustained commitment of donors.
Senator Dasko: Can you tell me about the social marketing that goes behind this? Who is targeted? What are the communications vehicles you are using? What is the messaging you are using?
Dr. Sher: We do a tremendous amount of research on social demographics and understanding the target audience. We use multiple vehicles of outreach, including social media and education, and we have an entire marketing and donor recruitment strategy behind this. It is about engaging with communities to understand what the needs are. There is a very sophisticated model of site selection. You have to be very careful where you put your location, so it is attractive and convenient for donors to get there. There is a lot, senator, in the approach to donors.
Senator Dasko: Yes, I am aware that the effort would be absolutely huge. Having worked in the past for federal and provincial agencies trying to promote, for example, organ and tissue donation — and there are a great many Canadians who have worked on this file. Yet, I saw a report about a month ago confirming that we are falling very short in our efforts to have organ and tissue donations. Of course, those are donated in this country.
Dr. Sher: If I could make one other point.
Senator Dasko: The donated model is hugely expensive to achieve, yet we have this partly compensated model now with some of the suppliers —
Dr. Sher: I need to make this one very important clarification, senator. Even the private, for-profit paid plasma industry takes at least a year from site identification until a donor base is built and doors are open. So it is no different in the paid model than it is in the non-remunerated. Building a donor base is a complicated process. If they use remuneration as a retention and recruitment tool, that is different than what we do. But even in that sector, they can’t turn this on a dime. That’s really important to appreciate.
Senator M. Deacon: In the interest of conciseness, I will pass. Senator Munson nailed it with the bill and the language. Thank you.
Senator Moodie: My question is about risk, specifically about the mechanisms available to regulate a control supply. It is not about safety. It is really not even about paid collection. It is more about risk, reaching our capacity, the security of our supply, and it is about diversification.
We heard from bioethics yesterday and Dr. Ballem today that there can be mechanisms put in place to regulate effectively, they believe, private, commercial entities who collect plasma.
We also heard, Dr. Sher, that you focused more on the end-of-contract vulnerability as one potential issue. You need to share with us what specific evidence you have that you have tried and understood what those legal regulatory ramifications could possibly be that would fail you.
Dr. Sher: Again, in the interests of brevity, senator, I will offer a couple of comments. This goes back to the question of why we don’t buy Canadian Plasma Resources’ plasma. One needs to understand the volume they have available is essentially a rounding error of what we are talking about here, in terms of achieving national sufficiency. That is the first point.
Were we to enter into a contract with them to buy it, the contract is only as good as the life of the contract. The global plasma industry has totally vertically integrated. The very big fractionators of plasma have bought up all the small collectors of plasma.
So when I look at the industry as a trend and the industry’s patterns around the world, I have very little confidence that this private collector will be there on a sustainable basis, delivering sufficient volumes of plasma to address security of supply. Plus, I’m not aware of any legal or legislative framework that could compel them to sell to me at a price that will not give them free rein to charge whatever they want and not face some anti-competition law. There are multiple challenges in this concept: compel a private player to sell its raw material to a public entity, and not to do business where it chooses to do business. Our argument is that we are the authority mandated to run the system in Canada, excluding Quebec. We have a clear mandate from the provincial and territorial governments, signed by the federal government in our MOU.
We are executing against that mandate and we can control the impact of the market, where we collect blood and where we need to collect plasma. We can’t get that control if there is an independent player out there over whom we cannot exert that control.
Senator Moodie: Thank you.
Senator Kutcher: I would like to make an observation that contract vulnerability is not unique to Canadian suppliers.
I have a question about security of supply being a problem. And you talked about increasing supply tensions, that there is global supply approach to plasma products and that Canada’s ability to meet the needs of people for these life-maintaining products is, in part, dependent on the global supply chain. And I hear your concerns and I share them very much of the supply tensions, which seems to be ramping up.
This bill would stop Canadians from entering the global marketplace and would then remove potential additional buffers in the global supply. It would not allow any Canadian to enter the global supply marketplace, so that if there are concerns about supply tensions in the global marketplace, this bill would shut that down. You can help me understand that?
Dr. Sher: My colleagues may have different views, senator. I’m not sure I agree with that conclusion. This bill, if passed, would simply mean that all plasma collected in this country would have to come from non-remunerated donors and it would serve the domestic sufficiency volume.
If we collect more plasma in this country, there is more plasma available to the rest of the world that we’re not buying the finished product from. That’s the implication. The more we collect in this country, the more we take the strain off our current dependence on the United States. That’s why every country needs to collect more — Europe, Australia, Canada, the U.K. We all need to collect more plasma.
Senator Kutcher: Dr. Ballem, what would your opinion be?
Dr. Ballem: Thank you, senator. In our report, it is very clear that the evidence of the success of creating the capacity to collect plasma does have a linkage to how you can manage the donor. For a donor of plasma, in the commercial sector, which is the vast majority of the source plasma collection, the commitment is a very different issue. In fact, the differential between the Héma-Québec and the CBS plans and actual operations is a very different approach. It is a much less frequent use of the donor to donate plasma. And I think that we have not really spoken about those things.
We are taking quite a modest approach to what is the norm for the vast majority of source plasma that’s collected in the world. I just think it defies the evidence base that has been built over decades that we will be able to reach our goal in a timely way. We have worked for years to try and get a fractionation industry in this country. And interestingly, we actually have four or five — if you include Green Cross — new fractionators, and some that have existed and are continuing to grow and move into broader areas that have just done that all on their own.
A goal we have had in Canada since the 1970s was to have a fractionation industry. We are a small country by population, but we are the same or a little bigger than Australia. So it is not impossible. I think it is complicated. I think we will be hard-pressed to get to our goals. We won’t be able to contribute as much as is possible to the global supply.
I think we are shutting some doors prematurely without properly thinking through, what are some other options?
The Chair: Dr. Germain, did you want to add something? No? Very well.
We won’t have the time for a second round of questions, and I apologize.
I would like to thank today’s witnesses, Dr. Germain, Dr. Sher and Dr. Ballem. Thank you very much for the relevance of your answers. We are grateful for the time you have given us to help in our study of this bill.
I would like to ask the senators to remain, and I will secure agreement in a short in camera session to discuss some other committee business.