Having spent the last two decades rebuilding Canada’s blood system and regaining the trust of Canadians in this critical part of the health fabric of the country, Canadian Blood Services feels compelled to respond to Anne Kingston’s article. While the article delves into many aspects of the complex world of plasma collections, it also contains statements that are inaccurate and unsubstantiated, not the least of which is the assertion that our organization has attempted to intimidate the regulator. This is untrue, not supported by the record, and fails to recognize the necessity of ongoing dialogue between blood system operator and regulator on matters of crucial interest to Canadians.
Canadian Blood Services was founded in 1998 to manage the national supply of blood, blood products and stem cells, and related services for all the provinces and territories (excluding Quebec), based on recommendations from the Krever Report on the tainted blood scandal. We put patients first, and are dedicated to improving patient outcomes through the manufacturing and delivery of safe, relevant, quality products and services to Canadians. I am writing today to clarify the role and perspective of Canadian Blood Services in the public debate on the emergence of commercial, for-profit plasma collection companies in Canada.
Canadian Blood Services has always monitored and managed plasma in Canada, which includes both safety and the security of supply. In 2004, we consulted with experts, governments, patient groups and other key stakeholders and determined that we would meet 100 per cent of patient need for intravenous immune globulins (Ig), the plasma protein products or plasma-derived drug in highest demand by patients, by collecting 40 per cent of the raw plasma needed to make plasma protein products, with the remaining 60 per cent of Ig demand met through finished drugs purchased from the international pharmaceutical industry (largely from the U.S.). In the years that followed, we determined Canada could safely lower the sufficiency target. However, recent increases in demand, coupled with the newly emerging threats to the global supply of plasma, have resulted in the need to bring the country’s sufficiency to a recommended 50 per cent. This approach balances the risk of a supply interruption with affordability of products, and provides some geographic redundancy. While it is true that the safety of plasma protein products was a concern in the 1980s and before, this has not been an area of concern since the modernization of fractionation and purification processes.
Over the years, the security of supply issue has been erroneously confused with the safety of plasma protein products made from raw plasma from paid donors. Canadian Blood Services has clearly stated that plasma protein products derived from remunerated plasma donors do not present a safety issue. There is no evidence that the level of safety of plasma protein products made from paid donors versus unpaid donors, differs. In addition to screening donors and thoroughly testing plasma, there are multiple steps built into the fractionation process known as inactivation steps and purification steps; the plasma products are rendered free of pathogens. Ultimately, plasma protein products are exceedingly safe, a fact that patient organizations themselves believe and support. This is the evidence-based position we have consistently shared with our funders and regulator. Indicating otherwise is misleading and misguided, especially given the thousands of patients in Canada who rely on life-saving and life-sustaining plasma-derived drugs. Not only is fostering panic over unfounded safety concerns potentially devastating to patients, it also introduces unnecessary confusion into the debate. That said, and consistent with the principles to which Canadian Blood Services has consistently held itself, we do not intend to pay plasma donors in our system.
Long-term security of the plasma supply for Ig can only be achieved through increased plasma collection by the publicly funded and publicly accountable not-for-profit blood system we operate on behalf of Canadians. Commercial plasma collectors are not bound to keep the products they collect from Canadians for use by Canadians; they can sell their products on the open market to the highest international bidder. For-profit companies also have no responsibility to consider the impact of paid plasma donations on the unpaid blood donor base. There is evidence internationally, not just in Canada, that when the for-profit, paid plasma systems expand rapidly, it can reduce the ability of the not-for-profit blood industry to meet its blood collection targets. In Hungary, for example, the expansion of for-profit, remunerated plasma collection entities has substantially affected the public blood operator’s ability to collect blood in that country (up to a 20 percent decline in blood donations). Even in more established markets, such as the United States, concerns are being raised that the significant expansion of for-profit paid plasma collection sites is impacting the non-remunerated blood operators’ ability to maintain market penetration. While Canadian Blood Services can likely manage the local challenges brought about by the presence of one or two for-profit clinics, it is the emergence of additional for-profit plasma collection sites, particularly larger-scale operations, that is of concern.
As the stewards of Canada’s blood system, we work with all levels of governments, patient organizations, suppliers, global experts, our counterparts in other countries and all other stakeholders within our evidence-based and risk-based decision-making framework in a transparent manner. As we manage the plasma protein product formulary for Canada, we meet with all potential players in the system. Canadian Plasma Resources did approach Canadian Blood Services. We have aimed to understand their business plan and have determined that their interests do not align with ours or with achieving domestic security of supply.
Canadian Blood Services shared an ambitious plan with governments almost one year ago, outlining how we will ensure a safe and secure supply of plasma needed to manufacture plasma protein products for Canadian patients by owning the infrastructure – starting with the collection of raw plasma and ending with securing access to plasma protein products for Canadian patients. The plan provides a roadmap for significantly increasing the amount of plasma we collect from Canadian donors, as per our voluntary, non-remunerated (unpaid), publicly funded collections model. At the conference of provincial and territorial health ministers in Edmonton in October 2017, “there was consensus that immediate action is needed to improve and expand domestic plasma collection,” as noted in a news release issued by ministers. We look forward to the report from Health Canada’s Expert Panel on Immune Globulin Product Supply and Related Impacts in Canada, and to governments’ response to our plan. Canadians rely on our system to supply them with the blood and blood products that they need, and we must work together in their best interest.
Dr. Graham Sher
Chief Executive Officer, Canadian Blood Services