25 years after the Krever commission, our commitment to patients remains
An open letter from CEO, Dr. Graham D. Sher
This week marks the 25th anniversary of the tabling of Justice Horace Krever’s report. This was commissioned to uncover the failings of Canada’s former blood system and the circumstances that led to tens of thousands of Canadians being infected and even dying from tainted blood transfusions.
Justice Krever’s report and its recommendations have served to guide those of us who have participated in the rebuilding of the system since 1998. There are many decisions we have made over the past 25 years, all informed and influenced by its findings. I reflect here on two of the more recent and impactful ones. One being the evolution in our plasma operations and the other referencing historic changes to our donor screening criteria.
While safety will always be paramount, 25 years later, an equally prominent concern is about security of supply, particularly of plasma and its derivative medicines. Plasma is the straw-coloured, protein-rich liquid in blood. It can be transfused directly into a patient for treatment or used as a starting raw material for the manufacture of several lifesaving biological drugs.
The most commonly prescribed plasma drug is immunoglobulin, used to treat a large number of inherited or acquired diseases. The demand for immunoglobulin has been rising inexorably both in Canada and internationally, while the available supply of plasma from which it is manufactured struggles to keep up.
For years we have raised concerns of international immunoglobulin shortages and the risks of Canada relying too heavily on global markets. Without a comprehensive supply chain for immunoglobulin in Canada, or the infrastructure to collect enough plasma to meet the needs of patients, Canada has had to rely on international markets. We have, however, been working to increase our domestic capacity and reduce our reliance on other countries’ supply and manufacturing capabilities.
With the pandemic, the risks to domestic security of supply have been brought into even starker relief. We saw supply chain failures impact vaccine and PPE availability. For similar reasons, access to immunoglobulin is more at risk than ever. Part of mitigating this risk means collecting more plasma in Canada; it also means creating the domestic capability to manufacture plasma into immunoglobulin.
Canadian Blood Services has been expanding our plasma collection network in Canada. However, we currently only collect enough to reach 15 per cent of the immunoglobulin needs of patients in Canada (otherwise known as ‘sufficiency’).
What is plasma sufficiency?
Plasma sufficiency is the percentage of plasma collected by Canadian Blood Services, as the accountable national blood operator, to manufacture immunoglobulins exclusively for patients in Canada. Learn more about plasma sufficiency and how we manage risk at plasma and the blood system supply chain.
Using an internationally recognized risk-based decision-making framework, Canadian Blood Services has determined that more needs to be done, and with urgency. Five sentinel recommendations came out of the latest application of this process; one of which was to continue to expand our current plasma collection network, and so we have.
Supported by funding from federal, provincial and territorial governments, by the end of 2024 we will have 11 dedicated plasma collection sites operating within our network (five are currently in operation).
The outputs of these centres will nearly double domestic sufficiency for immunoglobulin. But Canada must reach a minimum of 50 per cent immunoglobulin sufficiency, as assessed by the risk framework. To close this gap in the shortest time possible, another recommendation was for Canadian Blood Services to explore collaboration with the commercial plasma collection sector, to help deliver a domestic end-to-end immunoglobulin supply chain, from plasma collection through to domestic manufacturing.
After a rigorous, independently monitored and competitive procurement process, Canadian Blood Services signed an agreement with Grifols, a global industry leader in plasma collection and manufacture. Under this agreement, Grifols will collect additional plasma beyond what we collect in our network and will manufacture this into immunoglobulin in a new facility it is building in this country.
Our agreement includes critical controls to ensure Grifols’ commercial operation will not impact Canadian Blood Services’ national blood system operations. It also ensures that the plasma collected in Canada, stays in Canada for patients in this country. Being able to collect and manufacture plasma on Canadian soil drastically minimizes the supply risk to patients.
All of these advantages are contained in an agreement that ensures the security of blood and blood products, including plasma for immunoglobulin, remains under public purview, which, as Krever asserted in his report, is essential to the public good. We agree. Canadian patients will receive safe product, with far fewer supply threats, and continue to do so at no cost to them — as it should be.
Since we’ve announced our agreement with Grifols, Canadian Blood Services has been criticized by some for abandoning the Krever principles. The criticism, often centred around the differences between the paid donor model of the commercial sector and our non-remunerated model, misses several fundamental points. Safety of product is assured; risks to security of supply are greatly reduced; publicly insured access remains unchanged. The fact base in 2022 is vastly different from the 1980s, and we have developed a solution for the country that both upholds Krever’s principles and protects patients’ interests from global supply risks. It’s good news for patients and for Canada.
As I reflect on two and half decades of fulfilling Justice Krever’s recommendations, another big advancement comes to mind, this one around making donor screening practices more inclusive. Earlier this year, with tireless effort and dedication from stakeholders and members of the 2SLGBTQIA+ community, we moved to sexual behaviour-based screening for all donors. This means, we removed a long-standing and exclusionary policy of deferring men who have sex with men. This change has been a long time in the making, way too long for many.
For many years we have been committed to addressing this policy, which excluded many potential donors, and contributed to stigma and harm towards gay, bisexual, trans, and queer communities that already experience too much of both. We facilitated and gathered Canadian-specific research and modelling, while also monitoring what our international colleagues were doing, to inform our work on this policy. This provided us with the strong evidence we needed to show that the safety and adequacy of Canada’s blood and plasma supplies would be maintained with more inclusive policies in place.
We also leaned heavily on another strong principle from the Krever report: prioritizing stakeholder engagement and ensuring public participation in the decision-making framework. Many employees championed this change and engaged with many people and communities over many years, from our harshest critics to the patients who rely on our products. We sought their input and their advice. They challenged us and we accepted their challenge, working diligently to make a change that could benefit so many throughout the country.
Although there is still more work to be done to build a more diverse, equitable and inclusive transfusion and transplantation system, we now have a policy in Canada that asks all donors, irrespective of gender or sexuality, the same series of questions. We know that this latest change is imperfect and does not mean, unfortunately, that everyone impacted by our previous policy is now able to donate blood. This change is a mightily important one, and one that upholds so many of Justice Krever’s principles and findings — but it is just one change; one necessary step on our ever-evolving journey to establish a more inclusive national blood system.
As well as being the CEO of Canadian Blood Services, I am also a hematologist by training. Though I haven’t practiced medicine for 25 years, the patients I cared for in my clinical career are never far from my mind. Given their heavy reliance on blood during a time when tainted transfusions were a very real risk, I knew their concerns about safety, and about adequacy of supply. I observed and treated too many who suffered consequences of infected blood. I know what an unsafe and an untrusted blood system looks like, and I have had both the privilege and the honour to help lead an organization that has been relentlessly committed to restoring and retaining trust.
Justice Krever wrote his report at a time of great angst in a part of the public health system in Canada, a system that failed far too many, and for some in the ultimate way. The report has served to illuminate the way for us ever since its release, and I know from colleagues around the world that “the Krever report” is a roadmap for blood systems everywhere. We mark the 25th anniversary of his inquiry with great gratitude and pride knowing how far we’ve come since 1997. We remember and are humbled by the mistakes of the past. I personally, and Canadian Blood Services as an organization, have always looked back and learned from this period, as we have kept our eyes firmly focused on innovating for the future and optimizing a system that places safety as paramount and ensures security of supply for patients who depend us.
Dr. Graham D. Sher O.C.