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Drugs and Health Products

Round Table Discussion on Payment of Plasma Donors in Canada - Summary Report

Health Products and Food Branch

Toronto - April 10th, 2013

This report was prepared by: Intersol

The views expressed herein are those raised by the participants at the meeting and do not necessarily reflect those of Health Canada or the Government of Canada.

Table of Contents

Executive Summary

As a first step in fulfilling the pledge by the Minister of Health to seek the views of Canadians on the issue of compensation of plasma donors, Health Canada convened a Roundtable Discussion on Payment of Plasma Donors in Canada on April 10th, 2013 in Toronto. The objectives of the Round Table were to:

  • increase stakeholder's knowledge and understanding of the current use and regulation of plasma collected from paid and unpaid plasma donors;
  • provide opportunities for stakeholders to comment on paying plasma donors in Canada;
  • provide Health Canada with information respecting stakeholders' perceptions, opinions, concerns and knowledge regarding the payment of plasma donors; and
  • clarify the roles and responsibilities of all interested and affected parties.

Health Canada sought to hear the views of supporters as well as opponents of the practice of compensation; including, those who depend on the plasma for life-saving drugs and those who have safety and ethical concerns about the implications of for-profit plasma donation. Approximately 30 participants attended the roundtable, including representatives from the provinces, patient-advocacy groups, health professional organizations and individual advocates, as well as Health Canada, the Canadian Blood Services and Héma-Québec. Invitations had been issued to several other groups within these categories who either declined participation or did not reply to the invitation. The list of participants is available in Appendix A. The agenda can be found in Appendix B.

The morning agenda for the 1-day bilingual event featured two context-setting presentations, the first by Graham Sher, CEO of the Canadian Blood Services, and the second by Robert Cushman, Director General of Health Canada's Biologic and Genetic Therapies Directorate. Following the presentations, participants were given the opportunity to ask questions of clarification and make comments. Summaries of these presentations and the ensuing discussion can be found in Section 2 of this report. The following key messages were repeated by both CBS and Health Canada during their presentations and the ensuing discussion:

  • Payment by a private company for plasma donations has never and will never have any impact on Canada's voluntary system for collecting blood for transfusion. Only Canadian Blood Services and Héma-Québec collect blood and plasma for transfusion. This is a completely voluntary system and will remain so. Private companies in Canada do not collect blood or plasma for transfusion.
  • The payment of plasma donors, by privately owned collection facilities, for the purposes of creating pharmaceutically derived plasma products does not represent a change in practice for Canada. Private, for profit plasma collection has existed in Manitoba for several decades.
  • Plasma products are critical drugs needed by Canadians for the treatment of life-threatening diseases. Furthermore the demand for plasma products is increasing on an annual basis globally, including in Canada. The paid donor system is currently essential to ensuring a sufficient supply of plasma for the manufacturing of these products. To deny access for Canadians to products sourced from paid plasma would threaten the health and lives of thousands of Canadians.
  • Canada's need for plasma products significantly exceeds our current capacity to produce plasma for further manufacturing. Therefore in order to meet the needs of Canadians to have access to these critical, life-saving products, Canada must import large quantities of plasma products from the United States, most of which are manufactured from plasma from paid donors. For example, approximately 70% of immunoglobulin, which is used in Canada to treat a number of diseases, is made from paid donor plasma from the United States.
  • Collecting enough domestic plasma to be self-sufficient in plasma products is not operationally or economically feasible with a volunteer model. No country in the world has been able to meet their need for plasma with a solely volunteer model. Compensation of donors falls within the authority of the P/T governments. Currently, only Quebec has legislation that prohibits the payment of plasma donors. The payment of these donors is currently permitted under the legislation of the other P/Ts.
  • Blood collected for transfusion is separated into its different components, including the plasma fluid component, which has some uses in transfusion. However this type of collection is completely distinct from the plasma which is collected by private companies solely for manufacturing into commercial drugs known as plasma products.
  • Since the days of the Krever Inquiry, plasma product manufacturing technology has evolved and many of the identified risks from the past have been mitigated or eliminated. Canada and the US have strict regulations in place for the screening and testing of donors. Furthermore the manufacturing process for plasma products now includes multiple, mandatory steps which will remove or inactivate any contaminants, including viruses that could be present. These viral inactivation steps have proven to be extremely effective at eliminating new pathogens, such as West Nile Virus, which has been transmitted by blood transfusion, but never by use of plasma products.

The presentations and Q&A period were followed in the afternoon by small group discussions and a plenary report-back on the advantages, issues and concerns related to providing payment for plasma donors in Canada. Although the focus of the discussions was on issues and concerns, participants recognized a number of advantages to providing payment for plasma donors in Canada, including: increasing plasma donations at a time when domestic demand for drug products derived from plasma is constantly increasing; raising awareness of the need for blood donation in Canada; introducing more diversity of supply into the market, strengthening security of domestic supply and decreasing reliance on imported products, and; decreasing costs for the health care system.

With respect to issues of concerns regarding the payment of plasma donors, two distinct groups of attendees emerged during the discussions. Representatives of patient groups who depend upon plasma products expressed no concern about the safety of plasma products from paid donors as well as full confidence in Health Canada as the regulator to assure the safety of these products. Their primary concern was that a sufficient supply of these products must always be available. However certain individuals in attendance as well as some attendees representing health care organizations voiced a number of concerns, including ethical objections to the exchange of blood for money and concerns that donors attracted to be paid plasma donors would be pulled out of the pool of Canadians that would otherwise have donated whole blood voluntarily, thus jeopardizing Canada's supply of blood for transfusion. Concern was also expressed about the safety of paid plasma if provision of payment provided incentive for low-income, high-risk groups to become donors. In particular, concern that the enticement of high-risk donors could result in an emerging pathogen being introduced into the plasma pool was raised. Concerns were also expressed that there has been no national dialogue or public debate on this issue until now.

The issues and concerns were addressed by representatives from Health Canada, the Canadian Blood Services and Héma-Québec as they were brought forth. A summary of the advantages, issues and concerns related to providing payment for plasma donors in Canada, as well as Health Canada and the Canadian Blood Services' responses to the concerns expressed, can be found in Section 3 of this report.

At the end of the day, participants were given the opportunity to offer any final thoughts or closing comments. In closing, Paul Glover, Assistant Deputy Minister, Health Products and Food Branch, Health Canada indicated that the input gathered at this forum will serve to inform next steps that could be considered by Provincial and Territorial Governments. The closing commentary and final remarks have been summarized in Section 4 of this report.

Section 1: Introduction

1.1 Purpose of this Report

This report is intended as a summary of the proceedings and discussions of the Roundtable Discussion on Payment of Plasma Donors in Canada held on April 10th, 2013 at the Intercontinental in Toronto. It summarizes the views, opinions, perceptions, issues and concerns regarding the payment of plasma donors that emerged from the Roundtable discussions.

1.2 Purpose of the Consultation

The full-day bilingual Roundtable Discussion on Payment of Plasma Donors in Canada was organized by Health Canada in response to significant media interest, stakeholder enquiries and provincial and territorial positions on the compensation of plasma donors. The objectives of the Round Table were to:

  • increase stakeholder's knowledge and understanding of the current use and regulation of plasma collected from paid and unpaid plasma donors;
  • provide opportunities for stakeholders to comment on paying plasma donors in Canada;
  • provide Health Canada with information respecting stakeholders' perceptions, opinions, concerns and knowledge regarding the payment of plasma donors; and
  • clarify the roles and responsibilities of all interested and affected parties.

The Round Table brought together approximately 30 representatives from the provinces, patient-advocacy groups, health professional organizations and individual advocates, as well as Health Canada, the Canadian Blood Services and Héma-Québec. The list of participants is available in Appendix A. The agenda can be found in Appendix B.

Section 2: Background and Context

2.1 Opening Remarks

Paul Glover, Assistant Deputy Minister, Health Products and Food Branch, Health Canada, welcomed participants and thanked them for their attendance. He noted that the issue of payment for plasma donors is a very important one, and it has received a significant amount of media attention in the last several months. He noted there has been dialogue between provincial ministers and the Health Minister on this issue.

Mr. Glover indicated that the purpose of this Round Table is to hear the views of those that are most closely impacted by the issue of payment for plasma donors. The Round Table is also an opportunity to clarify the current situation regarding plasma donation and compensation, and put some basic facts on the table to facilitate the conversation as it moves forward. Mr. Glover noted that many organizations and individuals have already staked out a position, written to the Minister, or released a position paper on this issue. He pointed out that there will be mixed views in the room. He highlighted the importance of hearing from people what their views are on this issue, and committed to doing this in a respectful way moving forward.

Mr. Glover noted that the tainted blood tragedy has not been forgotten. He emphasized the importance of ensuring that the lessons learned from that tragedy are remembered and honoured moving forward. Today, Canada has one of the safest blood systems in the world. The goal is to ensure a safe, reliable system that continues to be responsive to the needs of Canadians, today and in the future.

2.2 Presentation by Canadian Blood Services

Graham Sher, CEO of the Canadian Blood Services, provided an overview of the foundation of the Canadian Blood Services and discussed the current system of blood for transfusion and blood product distribution. He shared some recent trends on the demand for plasma products, touching on domestic plasma collection and fractionation capacity and speaking to the role of paid plasma in the system.

Dr. Sher explained that the Canadian Blood Services currently purchases bulk pharmaceutical products from the US and Europe that are made from plasma (e.g. plasma protein products such as albumin and IVIG) on behalf of provincial and territorial governments for use in Canadian hospitals. These products are made from several plasma sources, including volunteer donors in Canada and the US, and paid donors in the US. He emphasized that internationally, the use of paid plasma in creating plasma protein products has been a common practice within the pharmaceutical industry for decades, and that the majority of the world's supply of plasma products comes from paid donors sourced by the plasma industry. He also pointed out that Canada does not have a large scale fractionator and therefore does not have the capacity to make these pharmaceutical products itself.

Dr. Sher spoke to advancements in plasma manufacturing technology, which now include steps to inactivate any viruses or other contaminants, known or unknown, and highlighted the fact that there has been no transmission of infectious disease through plasma products in Canada in 25 years. He also emphasized the point that today, the safety of plasma products from paid donors is no different than from unpaid donors. Further, Dr. Sher clarified that in Canada, patient access to safe and effective plasma therapies is, in fact, dependent on the international paid plasma industry. He noted that between 600,000 and 700,000 liters of plasma for fractionation per year would be required for Canada to become self-sufficient and meet today's demand, and that collecting this amount of plasma with a volunteer model is not operationally or economically feasible.

Following the presentation, Samantha Ghibu from Héma-Québec added that there is some work being done in Quebec, the only province where it is currently illegal to compensate plasma donors, to look at ways of incentivizing volunteer donors and to improve the overall donor experience. The ultimate goal is to increase volunteer blood donor collection in the province. However Héma-Québec re-emphasized the points made by Dr. Sher respecting the safety of plasma products and how paid donors from the U. S. are essential to ensuring a sufficient supply of these products.

Questions of Clarification

Following the presentation, participants were invited to ask questions of clarification. A number of questions and concerns were raised relating to the sustainability of the volunteer donor pool with the introduction of a competitor in the market (Toronto-based Canadian Plasma Resources), and regarding Canada's ability to become self-sufficient in meeting domestic demand for plasma products. Other questions pertained to the nature of products purchased by the Canadian Blood Services from Cangene, a Canadian company that has for several decades been producing plasma products from paid donors and whether or not CBS has any plans to purchase plasma from Canadian Plasma Resources if it is successfully licensed by Health Canada and becomes operational. Concerns were also raised that paid donation systems are perceived to be less effective at screening donors than volunteer-based systems.

2.3 Presentation by Health Canada

Building on Dr. Sher's presentation, Robert Cushman, Director General of Health Canada's Biologic and Genetic Therapies Directorate, provided an overview of how blood and plasma is currently regulated in Canada and discussed the roles and responsibilities of the various players involved in the blood system. A PDF copy of Health Canada's report is available upon request. To obtain a copy please send an email request to BGTD.OPIC@hc-sc.gc.ca.

Dr. Cushman restated that Canada has one of the safest blood systems in the world due to the strict standards set out in Health Canada's Food and Drugs Act and Regulations for the collection of blood and plasma. He emphasized that since the introduction of modern manufacturing practices over 25 years ago, there has not been a single case of transmission of Hepatitis B, Hepatitis C or HIV associated with a plasma product.

In Canada, blood and plasma used for transfusion is collected solely by the Canadian Blood Services and Héma-Québec, and only from volunteer donors. Dr. Cushman indicated that there are no plans to change Canada's voluntary blood for transfusion donor system. On the other hand, plasma used for the manufacturing of plasma products may be collected from donors who are compensated for their time. Dr. Cushman stressed that this is not a new practice, and approximately 70% of the immune globulins available in Canada are currently made in whole or in part from plasma from paid donors. He emphasized that plasma products distributed in Canada are manufactured in accordance with strict safety standards, regardless of where the plasma comes from and whether or not the donors were compensated.

Dr. Cushman emphasized that Canadian Blood Services and Héma-Québec do not currently compensate blood donors and there are no plans to change this practice. On the other hand, private clinics and companies may pay plasma donors provided it is permitted under the laws of the province or territory where they are located. Dr. Cushman assured that all establishments collecting plasma are strictly regulated and in compliance with the Food and Drugs Act and Food and Drug Regulations.

Questions of Clarification

Following the presentation, participants were invited to ask questions of clarification. A number of questions were raised regarding the criteria for licensure of plasma collection centers and whether any consideration is given to the location of the centers. Other questions related to the intent of Canadian Plasma Resources with regard to what it will do with the plasma collected and whether or not the plasma will remain in Canada. Participants also raised questions and concerns pertaining to the harmonization between provincial legislation regarding payment of plasma donors and federal licensure of establishments.

2.4 Key Messages from the Canadian Blood Services and Health Canada

Several common messages emerged from the presentations given by the Canadian Blood Services and Health Canada as well as the statement made by Héma-Québec. Throughout the morning presentations and ensuing discussions, these organizations repeatedly affirmed the following points:

  • Whole blood that is processed into red blood cells, plasma and platelets for transfusion is only collected by CBS and Hema-Quebec via a completely voluntary system. This is distinct from plasma alone, which may be collected by private companies solely for manufacturing into commercial drugs known as plasma products.
  • Plasma products are critical drugs needed by Canadians for the treatment of life-threatening diseases.
  • Canada's need for plasma products significantly exceeds our current capacity to produce plasma for further manufacturing. Consequently the majority of plasma products used in Canada are made currently from US-sourced plasma collected largely from paid donors.
  • The demand for plasma products is increasing and compensated plasma donors are currently critical to ensuring a sufficient supply of plasma products in Canada.
  • Collecting enough domestic plasma to be self-sufficient in plasma products is not operationally or economically feasible with a volunteer model.
  • Since the days of the Krever Inquiry, plasma product manufacturing technology has evolved and many of the identified risks from the past have been mitigated or eliminated. Canada and the US have strict regulations in place for the screening and testing of donors. Furthermore the manufacturing process for plasma products now includes multiple, mandatory steps which will remove or inactivate any contaminants, including viruses that could be present.
  • There is no federal legislation that prohibits an establishment that collects blood or plasma from compensating donors. Compensation of donors falls within the authority of the P/T governments.
  • The payment of plasma donors for the purposes of creating pharmaceutically derived plasma products such as Ig and Albumin does not represent a change in practice, as plasma products available to Canadian patients have been manufactured safely for decades using plasma from paid donors within the international plasma industry.

Section 3: Roundtable Discussion on Advantages, Issues and Concerns

Following the background presentations, participants were invited to discuss and respond to the following two questions at their table groups:

  • In your view, what might be the advantages of providing payment for plasma donors in Canada?
  • In your view, what are the issues and/or concerns related to providing payment for plasma donors in Canada?

Note-takers from each group captured the table discussions on an e-flipchart that was projected onto a screen at the front of the room. Highlights of the table group discussions were summarized in a report-back to plenary. A summary of the advantages, issues and concerns that emerged in these discussions, as well as other comments and suggestions, can be found in the sub-sections below.

3.1 Advantages

Although the focus of the discussions was on issues and concerns, participants recognized a number of advantages to providing payment for plasma donors in Canada, including:

  • Raising general awareness of the need and importance of blood donation in Canada to promote and sustain a healthy national blood supply. In addition, it was noted this may be opportunity to educate Canadians on the National Blood System in Canada and encourage donations of blood and plasma.
  • Increasing plasma donations at a time when domestic demand for drug products derived from plasma is constantly increasing. Specifically, it was noted that allowing companies to provide payment for plasma donations would increase the availability of 'Canadian source' plasma products to help meet the needs of Canadian patients, as well as decrease Canada's overall reliance on products imported from other countries (and in particular, the US).
  • Encouraging the continuing commitment of repeat donors (paid plasma donors donate more often that voluntary donors do).
  • Decreasing costs for the health care system and reducing the overall burden on the Canadian healthcare system.
  • Introducing more diversity of supply into the market. This is an important consideration with regard to the security of Canada's domestic supply going forward.
  • Contributing to the global supply as a reliable country with an excellent regulatory system and a relatively safe population.

3.2 Issues and Concerns

A number of issues and concerns were noted related to providing payment for plasma donors in Canada, including perceived safety concerns, issues pertaining to the possible erosion of the voluntary donor pool and the security of the blood supply, ethical concerns, the need for public consultation on this issue, and the perceived need for central coordination or oversight of the national blood system. Throughout the discussion, representatives from Health Canada and the Canadian Blood Services tried to address some of these issues and concerns as they arose. The issues and concerns are summarized below, in no particular order of importance, followed by summaries of the responses by Health Canada and the Canadian Blood Services in the blue comment boxes.

3.2.1 Perceived Safety Concerns

Overall, there was a lot of sensitivity to the idea of a private-sector blood collection industry in Canada, much of which related to the tainted blood tragedy of the 1980's, when many Canadians were infected with HIV and hepatitis through tainted plasma products. There was concern that allowing payment for plasma would increase the risk of another tainted blood tragedy. Although it was recognized that studies have shown that there has not been a single case of transmission in the use of plasma-derived products in the last 25 years, the safety concerns presented were more hypothetical in nature. The fear was that providing payment for blood donations would introduce a perceived risk into the system because it would incentivize low-income, high-risk groups to 'sell their plasma for fast cash'. This fear centered on the belief that unpaid volunteers donating blood and plasma for altruistic reasons are less motivated to lie about health issues on screening tests. Whether or not this is the case, it was noted that the locations of paid donor centers in Toronto next to a homeless shelter and a university campus creates an additional 'optical' safety concern.

There was a fear that introducing for-profit corporations into blood collection may result in commercial concerns taking precedence over the safety and well-being of Canadians who depend on a safe blood system.

In response to these concerns, Health Canada and the Canadian Blood Services emphasized that the payment of plasma donors does not represent a change in practice, as plasma products available to Canadian patients have been manufactured safely for decades using plasma from paid donors within the international plasma industry, including by Cangene, a Canadian company which is a global supplier of plasma products made from paid Canadian donors. Since the introduction of modern manufacturing practices over 25 years ago, there has not been a single case of transmission of Hepatitis B, Hepatitis C or HIV associated with a plasma product. Since the days of the Krever Inquiry, plasma product manufacturing technology has evolved and many of the identified risks from the past have been mitigated or eliminated. The manufacturing process for plasma products now includes multiple, mandatory steps which will remove or inactivate any contaminants, including viruses that could be present.

Canada and the US have strict regulations in place for the screening and testing of donors, regardless of where the plasma comes from and whether or not the donors were compensated. In addition, there are very strict regulations for licensure of a plasma collection center. The license application is very comprehensive and covers several dimensions including the establishment, equipment, quality systems, procedures, purchasing agents, and chemicals.

In their License application, operators must demonstrate that they are able to address all donor safety issues and any specific risks. Specifically, they must demonstrate proper standard operating procedures to ensure all high-risk donors are eliminated by the rigid screening criteria. Such strategies include only accepting donations from repeat donors and donors with fixed addresses.

3.2.2 Erosion of Voluntary Donor Pool and Security of Supply

The concept of using financial incentives to attract plasma donors raised concerns about whether or not parallel donor systems could co-exist in Canada. There was a general concern that the donors attracted to be paid plasma donors would be pulled out of the pool of Canadians that would otherwise have donated whole blood voluntarily. This concern about the erosion of the Canadian Blood Services' volunteer donor base raised questions about how the organization plans to compete with paid donor centers to retain and attract new donors. Although the CBS plans to monitor impacts on the voluntary donor supply, participants were concerned that there was no plan in place to protect the public system if a private system is implemented in parallel.

In response to these concerns, the Canadian Blood Services emphasized that they will be monitoring the impacts of new donor-paid facilities on the voluntary donor supply, but that given the experience of implementing parallel systems in jurisdictions in both Europe and the United States, they do not expect it to be an issue. It was emphasized that only 4% of Canadians donate blood, and it is expected that only 8% of those donors will move between the two systems due to the fact it requires a commitment for continued ongoing donations. Canadian Blood Services had also indicated, during their presentation, that the existence of the paid plasma donor facility operated by Cangene in Winnipeg had not negatively impacted voluntary donations there.

3.2.3 Ethical Concerns

There were some issues and concerns with the perceived possible ethical dilemma presented by the exchange of money for blood products. Specifically, participants were concerned that allowing payment of donors for plasma donations would constitute a 'slippery slope' that may justify payment for other body parts in the future.

In response to these ethical concerns, Health Canada and the Canadian Blood Services emphasized that the use of paid plasma in creating plasma protein products has been a common practice within the international pharmaceutical industry for decades, and that the majority of the world's supply of plasma products comes from paid donors sourced by the plasma industry.

Canada's need for plasma products significantly exceeds its current capacity to produce plasma for further manufacturing. Consequently the majority of plasma products used in Canada are made currently from US-sourced plasma collected largely from paid donors. Patient access to safe and effective plasma therapies is dependent on the international paid plasma industry.

3.2.4 Need for Consultation

Many participants were concerned that the issue of payment of plasma donors in Canada has just recently been brought forth for public consideration, and that there has been no national dialogue or public debate on this issue until now. The need for open consultation was highlighted multiple times.

In response to these concerns, Health Canada and the Canadian Blood Services emphasized that there has been no change whatsoever with respect to Health Canada's regulations - they are the same and continue to be the same. Canada's blood policy has evolved only to account for safer technologies and practices, and to increase the safety measures that exist. There is no contemplation of any change in policy. The input gathered at this Round Table will inform next steps on this issue, and the strong desire for further consultation will be communicated back.

3.2.5 Need for Central Coordination or Oversight of the National Blood System

There was an apparent level of misunderstanding about the operation of the National Blood System in Canada and the roles and responsibilities of the federal and provincial governments. Concern was expressed that there seems to be no central body responsible for oversight of the national blood system. This concern stemmed from a perceived disconnect in the relationship between the federal and provincial regulators. Participants highlighted the fact that Ontario Health Minister Deb Matthews urged her federal counterpart, Leona Aglukkaq, not to approve licensing of Canadian Plasma Resources' paid donor centers without open consultation as an example of this disconnect. There was a concern that the introduction of paid plasma centers would result in additional layers of complexity in this system.

In addition, concerns were expressed over the national surveillance system and Canada's ability to identify emerging pathogens through this system due to the fact that the safety information currently available is outdated (the most recent safety report is from 2005). This is a source of frustration for those that are actively involved in the transfusion process. The national surveillance system needs a lot of work and updating. Several participants felt there should be national coordination on this.

The governance structure of the National Blood System and the roles and responsibilities of the federal versus provincial and territorial governments had been detailed earlier in the day in the Health Canada presentation. In response to these concerns, Health Canada and the Canadian Blood Services emphasized the fact that the national blood system is not a solely a federal or provincial responsibility - it is a series of legal frameworks that work together. The reality of the system that was created in this country is one that is multijurisdictional, and the lines of responsibility of the federal, provincial and territorial governments must be respected. Blood policy is part of health system delivery, which is a provincial responsibility. There is no federal legislation that prohibits an establishment that collects blood or plasma from compensating donors: Compensation of donors falls within the authority of the P/T governments.

Any establishment is required to comply with federal laws around establishments and products, as well as whatever other provincial laws are in place, and there is a requirement on all levels of government to enforce their applicable rules and regulations.The two systems work together to create awareness and enforcement of the regulations in place.

3.3 Other Comments and Suggestions

Other comments and suggestions that emerged throughout the roundtable discussion have been summarized below.

  • Overall, there was a lot of support for one of the key recommendations from the Krever Inquiry Report - that significant efforts be made to ensure that blood components and blood products used in Canada are made from the blood and plasma collected from unpaid donors. Specifically:
    • Some participants felt that the CBS has the ability to improve plasma sufficiency in Canada by providing greater collection opportunities in the volunteer donor system.
    • A suggestion was made to consider 'rightsizing' demand for blood products in Canada (if Canada is out of step with its demand for IVIG products as compared to other countries).
  • Several participants pointed to Justice Krever's recommendation that Canada maintain an open and transparent blood system and consult with the public before changing the volunteer system. Because it was felt this is a public policy issue that impacts all Canadians, there was a recommendation for a cross-country public consultation on the matter. Patients that use plasma products were identified as a key stakeholder groups that must be consulted on this issue, as they are the ones that are familiar with safety issues and most concerned with security of supply.
  • There was a call for Health Canada to centrally coordinate a national dialogue to inform and educate Canadians on the issue of compensation of plasma donors. This was in response to concerns related to the perceived lack of information available on this issue.

Section 4: Closing Remarks

4.1 Closing Commentary

At the end of the day, participants were given the opportunity to offer any final thoughts or closing comments. This closing commentary has been summarized by stakeholder group in the sub-sections below.

Patient Groups

  • There is a very fragile balance to be struck between safety and security of supply - patients should always have access to the safest blood products and they should never be denied access to a product they need - their lives depend on it.
  • We have full confidence in the Canadian blood system, in Health Canada and in the Canadian Blood Services and Héma-Québec.
  • There has not been a single case of transmission of blood-borne pathogens in the use of plasma-derived products in the last 25 years. At the end of the day, this will only serve to increase the availability of supplies for patients who really need them and help to meet increasing patient needs.
  • There must be a concerted effort to inform and educate Canadians on this issue because they are largely unaware that 70% of plasma products currently come from paid plasma donors in the US. Another key message that must be communicated to Canadians is that that this will not affect the fresh blood supply in Canada.

Individual Advocates

  • This exercise has been very helpful. Because mistakes have been made in the past due to lack of transparency and accountability in the system, it is easy to be mistrustful of the players involved. If there is a perception that this is happening again, it will create a great deal of anxiety for many Canadians. Having a national dialogue on this issue will be a critical step in ensuring past mistakes are not repeated.
  • There is a strong hope that there will be Canada-wide consultations with patient groups and ongoing users of blood and blood products. Ultimately, it should be up to them to decide.
  • All efforts should be made to satisfy patient needs by increasing voluntary blood collection before moving to a parallel system.

Health Professional Organizations

  • Due to the efforts of the Canadian Blood Services, Héma-Québec and Health Canada, Canada currently has one of the safest blood supplies in the world. Amazing work has been done to accomplish this in the last few years. Our organization's major concern today is the erosion of the pool of voluntary blood donors with the introduction of a competitor in the market.
  • Thank you to Health Canada and the Canadian Blood Services for beginning a national dialogue on this important intra-jurisdictional matter.
  • This is not an easy discussion. Many stakeholders are passionate about this issue for various reasons. Everyone shares a common goal of wanting to ensure an ongoing safe system in Canada. It is up to the Government of Canada to work with the provinces to make sure there is appropriate and sufficient public consultation on this issue, and to ensure the consultation process is as open and accessible as possible.
  • The federal government must initiate further discussions with the provinces and territories to provide more clarity on this issue and better delineate roles and responsibilities in the national blood system.

4.2 Closing Remarks and Next Steps

Paul Glover, Assistant Deputy Minister, Health Products and Food Branch, Health Canada, thanked participants for their attendance and made the closing remarks. A number of opinions and views were shared throughout the roundtable discussions and these views will be difficult to reconcile. Despite the differences in opinion, everyone has the same goal in mind - to ensure a safe, reliable system that continues to be responsive to the needs of Canadians, today and in the future.

Mr. Glover assured advised participants that the input gathered at this forum will inform next steps on this issue, and that the desire for further consultation will be communicated back. A summary report of this meeting will be distributed to participants as well as shared with Provincial and Territorial governments. This report will also be posted on the Health Canada website and all stakeholders will have an opportunity to provide comments on the issue of payment of plasma donors in Canada.

Appendix A: List of Participants

List of Participants
Name Organization
Graham D. Sher Canadian Blood Services
Linda McIntyre Canadian Blood Services
Jean-Paul Bédard Canadian Blood Services
Samantha Ghibu Héma-Québec
Debbie Lauzon Canadian Society of Transfusion Medicine
Rachel Baird Canadian Nurses Association
Allissa VonBargen Canadian Doctors for Medicare
Sean Meagher Canadian Doctors for Medicare
Craig Upshaw Canadian Hemophilia Society
David Page Canadian Hemophilia Society
Monique Doolittle-Romas Canadian AIDS Society
Tamara Armoogan Hereditary Angioedema Canada
Mary Gustafson Plasma Protein Therapeutics Association
Michael McCarthy Individual advocate
Riyad Elbard Thalassemia Foundation of Canada
Antonia Swann Individual advocate
Dr. Jun Wun Public Health Agency of Canada
Dr. Jerry Teitel St-Michael's Hospital Toronto
Bernadette Muise New Brunswick Department of Health
Dai Kim Ontario Ministry of Health
Sandra Gram Ontario Ministry of Health
Cathy Parker Health Canada
Robert Cushman Health Canada
Alastair Sinclair Health Canada
Ted Laking Health Canada

Appendix B: Agenda

Round Table Discussion on Payment of Plasma Donors in Canada
Toronto InterContinental Toronto Centre, 225 Front Street West, Ontario Room
April 10, 2013

Participant Agenda

Purpose:

  • to increase stakeholder's knowledge and understanding of the current use and regulation of plasma collected from paid and unpaid plasma donors;
  • to provide opportunities for stakeholders to comment on paying plasma donors in Canada;
  • to provide Health Canada with information respecting stakeholders' perceptions, opinions, concerns and knowledge regarding the payment of plasma donors; and
  • to clarify the roles and responsibilities of all interested and affected parties.
09:00 - 09:20
Arrival, Registration and Refreshments
09:30 - 09:45
Opening - Call to Order, Review of the Agenda and Tour de table (Introductions)
Raymonde D'Amour- Intersol
09:45 - 10:00
Opening Remarks & Context Setting (followed by Qs and As)
Paul Glover, Assistant Deputy Minister (ADM) - Health Products and Food Branch (HPFB), Health Canada
10:00 - 10:25
Presentation by Canadian Blood Services
Dr. Graham Sher, Chief Executive Officer, Canadian Blood Services (CBS) Ottawa
10:25 - 10:50
Qs&As
10:50 - 11:05
Water/Coffee Break
11:05 - 11:30
Presentation by Health Canada
Dr. Robert Cushman, Director General, Biologic and Genetic Therapies Directorate (BGTD)
11:30 - 12:00
Qs&As
Morning wrap-up and prep for afternoon conversations
Thank you to all
12:00 - 12:30
Lunch (provided)
12:30 - 14:20
Roundtable discussion
Water/Coffee Break
Roundtable discussion (cont'd)
14:20 - 14:50
Open mic participant closing commentary
Those in attendance who wish to make a closing commentary will be invited to do so
14:50 - 15:00
Wrap up and next steps
Paul Glover, ADM - HPFB
15:00
Adjourn
15:00 - 15:15
Officials meet with the media for Q&A
Paul Glover, ADM - HPFB