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.
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:
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:
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.
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.
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:
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.
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.
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.
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.
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.
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.
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:
Following the background presentations, participants were invited to discuss and respond to the following two questions at their table groups:
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.
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:
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.
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.
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.
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.
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.
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.
Other comments and suggestions that emerged throughout the roundtable discussion have been summarized below.
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.
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.
|Graham D. Sher||Canadian Blood Services|
|Linda McIntyre||Canadian Blood Services|
|Jean-Paul Bédard||Canadian Blood Services|
|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|
Round Table Discussion on Payment of Plasma Donors in Canada
Toronto InterContinental Toronto Centre, 225 Front Street West, Ontario Room
April 10, 2013