Dr. Graham Sher
Letter to the editor of Maclean’s in response to “A bloody mess: The story behind paid plasma in Canada” as published on Nov. 22, 2017
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
Open Letter to the Honourable Commissioner Judge Horace Krever (retired)
On behalf of all of our employees at Canadian Blood Services, as well as the many donors, volunteers and countless individuals whose lives have been touched by Canada’s national blood system, it’s my privilege to offer you our collective thanks. Your remarkable contribution to health care in this country is felt to this day.
It has been 20 years, and much has changed. Yet the Final Report of the Commission of Inquiry on the Blood System in Canada remains an invaluable benchmark for Canadian Blood Services and other blood operators around the globe. Your vision for a national, accountable, public blood service, laid the groundwork for the organization I’m humbled and proud to lead. In my collaborations with our international counterparts, your report is still considered the blueprint for blood systems worldwide.
Over the years, I’ve been asked many times whether the contaminated blood crisis could happen again. Are we immune from the conditions that once crippled the blood system causing harm to so many? It is a question that continually prompts me to think about those aspects of our current system that are most likely to mitigate against a repeat of the past. It is the reason we strive to maintain clear governance accountabilities, including the appropriate arm’s-length relationship between funder and operator; transparency; public participation in our decision-making; and a relentless focus on safety, quality and security of supply, among others.
In the 1980s and 1990s, Canadians lost faith in the public health system. Your report gave us the necessary blocks to rebuild their trust, and the wherewithal to prevent a tragedy of this magnitude from happening again. The emphasis we place on trust within our corporate culture and mission compels us to continue to earn it every day.
Your contribution to Canadian health care is nothing short of monumental, and it must never be forgotten. Sadly, an entire generation is largely unaware of the extent to which the system failed, and perhaps more significantly, why and how it has been rebuilt. In a recent poll conducted by Ipsos on our behalf, fewer than half of Canadian respondents indicated some level of awareness of the Krever Inquiry and its findings.
Whenever I am involved in orienting new employees at Canadian Blood Services, I insist on beginning with a discussion of your work. It is a knowledge those entrusted to manage the system must have, and which must be kept at the centre of our work, no matter how remote we may seem to be from the years of the contaminated blood crisis. The cost of not doing so is simply too high, and the potential consequences are unacceptable.
I appreciate the dialogue sparked by those who dare to ask: “How certain are we that today’s system is less likely to fail the patients whose lives and health depend on it?” Guided by your report, we have made many changes over the past two decades to safeguard the system for Canadians. I am confident the system we have today is more robust, agile and capable of detecting and averting threats than ever before.
While I do offer the assurances above, we must continue to be vigilant in managing a safe, secure and accessible supply of blood and blood products. We must strike the right balance between collaboration and independence in our relationships with a range of stakeholders across the country. This is how we will keep your legacy at the core of why we come to work every day.
You have my thanks and personal commitment to keeping this legacy top of mind.
Dr. Graham D. Sher
Chief Executive Officer
Canadian Blood Services
As published by The Hill Times, Nov. 22 2017.
Canadian Blood Services CEO recognized as one of Canada's most powerful doctors
Canadian Blood Services is pleased to share that our CEO, Graham Sher, MD, PhD, has been recognized by his peers as one of Canada’s most powerful doctors. The announcement was made in the September 15, 2015 edition of The Medical Post, a publication of the Canadian Heathcare Network.
Dr. Sher is described as being at the helm of Canadian Blood Services for more than a decade and helping to create one of the world’s safest blood systems. He has led a variety of initiatives to help improve Canada’s organ and tissue donation and transplantation system; advocated that policymakers tap into our organization’s unique pan-Canadian experience to help address critical health-care issues; and recently established Canada’s first national public cord blood bank that will increase the chances of patients who need a stem cell transplant to find a match.
The Medical Post’s compilation of influential professionals includes an impressive array of men and women in Canadian healthcare. Canadian Blood Services is proud to see Dr. Sher included among such a distinguished group of Canadian leaders.
Graham Sher: Canadian Blood Services as a model for national pharmacare
National Post, Toronto ON — Imagine having to choose between putting food on the table or buying necessary medication. Research suggests this is the case for one in 10 Canadians who can’t afford to fill their prescriptions. Canada is the only country with universal health care that does not also have universal drug coverage. Even for those who do have private or public drug coverage, there are discrepancies in what and who is covered from province to province. Canadians also pay more for drugs than citizens in almost any other Western nation.
These are just a few of the arguments that have reignited calls for a national pharmacare program. It is not a new concept, but one that is gaining traction as leaders are turning over every stone to “bend the cost curve” in health care downward. In a recently published study in the Canadian Medical Association Journal (CMAJ), health economists and researchers concluded a universal drug program could actually save Canadians billions of dollars. Great savings are achieved by pooling provincial and territorial needs and resources to increase buying power, eliminate duplication and establish a platform for collaboration and cost-sharing.
If health-care leaders are looking for proof that provinces and territories can do more together than they can on their own when it comes to the provision of life-saving and enhancing drug therapies, they need look no further than the blood system they created close to 20 years ago.
Many are aware that since its creation in 1998, Canadian Blood Services has been in the business of collecting, processing and distributing blood components in all provinces and territories outside Quebec. But few realize we have also been running a national formulary of biological drugs, providing universal and equitable access to plasma-derived medicine at no cost to patients for nearly two decades
Our organization has sole responsibility for managing a national portfolio of plasma-derived products and their synthetic alternatives worth about $500 million a year. These life-saving pharmaceuticals are used to treat people with hemophilia and other bleeding disorders, patients with inherited and acquired immune disorders, burn and trauma victims, and many others. A national, scalable, cost-shared infrastructure and logistics network ensures the right product get to the right patient, at the right time.
Our approach to managing this drug portfolio is based on best practices in public tendering. This means we provide a competitive, transparent mechanism to achieve best pricing. In fact, governments are benefiting from Canadian Blood Services’ success in negotiating an estimated $600 million in savings over five years through 2018 — a testament to the value of pan-Canadian buying power and proof of concept of one of the arguments in the CMAJ study.
Some detractors of tendering suggest it can put supply at risk by placing all the purchaser’s eggs in that one proverbial basket. However, in our process, we avoid single-sourcing whenever possible, not only to encourage competitive pricing, but to ensure security of supply. Carrying multiple brands of a product, purchasing them in smaller, diverse lots, and negotiating a dedicated and guaranteed “safety stock” are all measures we take to mitigate risks to supply disruption.
We have also focused on product choice by incorporating stakeholder (physician and patient) input where appropriate in our tendering processes. Through our medical directors, we provide expert advice when a physician has a patient-based issue that could benefit from an additional specialist perspective — added value for patients and health systems. We also independently qualify new suppliers and audit them periodically, adding another layer of vigilance and product safety for patients. We are often aware early on of supplier issues in bringing products to market or maintaining adequate Canadian supplies, which helps to mitigate the risk of shortages.
Because of our governance structure, once a plasma-derived drug is accepted in our portfolio, it becomes available in all jurisdictions. This practice effectively reduces geographic or financial barriers to care, and is consistent with the principles of universal access informing the Canada Health Act and medicare. Equitable access also encourages consistency of practice, and fosters pan-Canadian dialogue on best practices for optimal product utilization. Canadian Blood Services collaborates with health-system leaders, including governments, transfusion medicine physicians and others, to help ensure appropriate utilization and to further control costs.
By offering our experience, we are not proposing Canadian Blood Services should bulk-purchase other drugs or that our model is a “cookie cutter” solution to apply to national pharmacare, in part or in whole. Rather, we are suggesting there are important lessons from our 17 years’ experience that can be leveraged, and that a national drug program is not only possible — it is already being done, with significant benefits to patients and health system funders.
A system that ensures no Canadian patient is left unable to afford life-saving medication, while at the same time driving down system costs, is not only good politics, it’s good policy.
View article in the National Post, published on April 13, 2015
Organ donation in Canada: The large gap between what is and what could be
Through remarkable advances in transplantation, organ donation saves and improves lives and is cost effective. However, Canada’s organ donation record is mediocre, with less than half the donation rates of leading countries. One-third of Canadians who need a transplant will never receive one.
While Canada has seen modest improvements over the past decade, the Canadian Institute for Health Information’s recent report, Deceased Organ Donor Potential in Canada, reveals that there is a large and troubling gap between the number of people who could be organ donors and the number who actually donate. This valuable and informative report demonstrates:
- Most potential organ donors are not recognized or identified by health-care professionals in hospitals. (The report acknowledges limitations to the data on donation potential, which is based on indirect estimates.)
- Donation services vary significantly across the country. Whether a potential donor becomes an organ donor depends to a great degree on the province, city, hospital and area within the hospital in which he or she receives care.
- One form of donation — donation after circulatory death (DCD) — is still not offered in all provinces and cities. This type of donation substantially improves donation rates and the availability of transplants for Canadians who need them.
In April 2011, Canadian Blood Services, working in collaboration with the Canadian and international organ donation and transplant communities, delivered a series of recommendations to provincial and territorial governments to improve donation and transplantation services. The report identified several fundamental requirements to improve the organ donation system:
- Leading practices and professional education in deceased donation for health-care professionals in hospitals.
- Organ donation experts, both nurse coordinators and donation physician specialists, who ensure organ donation is offered to all families in all hospitals when appropriate.
- Organ donor registries that are consistent across the country, easily accessible, available online and used to legally authorize organ donation based on the expressed wishes of the donor.
- Medical record reviews that find missed donation opportunities.
- A committed hospital culture that recognizes that when death is inevitable and there is an opportunity to save many lives through organ donation, this should be a health-care service priority.
- Better measurement and reporting of donation and transplant outcomes.
In many countries, national audits on organ donor potential like the CIHI report have led to better organ donation systems. CIHI used indirect data to estimate donation potential in Canada. For Canada to get the most out of its audits, we need standardized, system-wide medical record reviews to identify missed donation opportunities.
Every life lost while waiting for transplant is preventable. The CIHI organ donation potential report demonstrates the glaring discrepancy between what could be achieved and what actually happens in our system. It also emphasizes the importance of Canadian Blood Services’ collaborative work with governments and organ donation programs toward implementing these proven lifesaving and life-enhancing solutions. Canadians whose lives depend on them are counting on it.
See the Canadian Institute for Health Information’s Deceased Organ Donor Potential in Canada report.
Dr. Graham D. Sher
|Dr. Sam Shemie
Medical Advisor, Donation
Canadian Blood Services