Blueprint for greater security of immunoglobulins for patients in Canada

Sept. 7, 2022 (OTTAWA) – In response to an ongoing global shortage of immunoglobulins and risks to cross-border supply chains made further evident by the pandemic, Canadian Blood Services is announcing a blueprint for action to ensure patients in Canada continue to have long-term access to these lifesaving therapies. Immunoglobulins are the most widely used medications made from plasma, a component of blood.

The blueprint was developed following a robust risk analysis, which followed an internationally recognized framework used by blood operators to enable complex evidence-based decision-making. This analysis was informed by patients, clinicians, industry and market analysts, health economists, specialists in ethics and law, as well as the experience of other blood operators around the world.

The analysis generated five key recommendations for managing escalating risks to Canada’s supply of immunoglobulins, quickly and responsibly. These include:

1. Undertaking additional risk-mitigation measures with urgency
2. Pursuing a targeted range of approximately 50–60 per cent domestic plasma sufficiency to meet patients’ most critical needs in Canada — conditions for which no other treatment options exist
3. Leveraging both not-for-profit and commercial sectors
4. Continuing work with the National Emergency Blood Management Committee, a pan-Canadian expert advisory body, to address short-term product shortages
5. Maintaining active monitoring of supply and demand for immunoglobulins

“The need to secure Canada’s supply of plasma for immunoglobulins has been a top blood system priority for several years,” says Dr. Graham D. Sher, Canadian Blood Services chief executive officer. “Globally, many countries are increasing sufficiency levels in response to alarming supply constraints. In Canada, federal, provincial and territorial governments are supporting Canadian Blood Services in reaching approximately 25 per cent domestic immunoglobulin sufficiency through a total of 11 dedicated plasma donor centres over the next few years. While we are moving in the right direction, there remains a significant gap to meet a minimum 50 per cent domestic sufficiency target needed to secure supply for patients who use immunoglobulins on a lifesaving basis.”

At the same time, the landscape related to plasma has changed, with the growth of the commercial plasma collection industry and ongoing development of the country’s first large-scale manufacturing plant for plasma-derived medications. As a result, Canadian Blood Services has been working to:

• Determine if plasma collected domestically by the commercial sector could contribute to Canadian Blood Services’ efforts to increase sufficiency of immunoglobulins — so that plasma collected in Canada stays in Canada, to be manufactured here for the exclusive benefit of patients in Canada.
• Establish controls to ensure the growth of commercial plasma activity in Canada does not impact or impede Canadian Blood Services’ national blood and plasma collection operations.

To address this, and to further inform Recommendation 3 of the blueprint (leverage both not-for-profit and commercial sectors), Canadian Blood Services conducted a comprehensive request for proposal process. The goal of the process was to assess whether the growing commercial plasma sector in Canada could help increase plasma collection and deliver a much needed end-to-end, domestic supply chain, while safeguarding the nation’s existing integrated blood and plasma supply chain.

In keeping with the recommendations, the process resulted in an agreement with Grifols, a global healthcare company and leader in producing plasma medicines. Canadian Blood Services and Canada’s broader transfusion community have had a long and positive relationship with Grifols, which has manufactured medications at its facilities in the United States from plasma collected in Canada for more than 30 years. The company has gained deep knowledge of Canada’s plasma market and health-care systems and has helped meet the needs of tens of thousands of patients in Canada for decades.

“As Canada's unified patient voice on matters of blood supply and safety, representing thousands of Canadians whose lives depend on blood and plasma-derived medicinal products, NRBDO members are very optimistic about an agreement between Canadian Blood Services and Grifols. We have long advocated for an approach that includes working with the commercial sector to ensure Canadian patients have access to life-saving plasma-derived medicinal products when needed. Increasing Canada’s plasma sufficiency to at least 50 per cent is critical in ensuring that access," says Jennifer van Gennip, Executive Director, Network of Rare Blood Disorder Organizations.

"The Canadian Immunodeficiencies Patient Organization (CIPO) supports any efforts by Canadian Blood Services to increase Canada's plasma supply. As the patient voice for patients living with primary immunodeficiency disease, who have been identified by Health Canada as the only patient population with life-sustaining need of the plasma derived medicine, immunoglobulin (Ig), we realize the very real and urgent need to secure safe and continued access to supply for thousands of patients across Canada,” says Whitney Goulstone, Executive Director, Canadian Immunodeficiencies Patient Organization.

Through this agreement, Canada will reach a minimum target of 50 per cent sufficiency in the shortest time possible: Canadian Blood Services will increase and maximize its plasma collections to achieve approximately 25 per cent, as planned, and Grifols’ plasma collections will deliver the remainder. All of that plasma will then be used by Grifols to manufacture immunoglobulins in Canada exclusively for patients in Canada.

Under this agreement, Grifols will open select plasma collection centres in Canada. Canadian Blood Services will also continue to grow our capacity to collect more plasma. Since 2020, we have opened five dedicated plasma donor centres (Kelowna, B.C.; Lethbridge, Alta.; Brampton, Ottawa and Sudbury, Ont.), with three more in Abbotsford, B.C., and in St. Catharine’s and Vaughan, Ont. planned for spring 2023. Another three centres will follow in 2024, with potential for further growth depending on the country’s sufficiency needs.

Protections for the national blood supply system are a vital part of the agreement and include controls to prevent negative impacts on Canadian Blood Services’ current and future network of blood and plasma donor centres. The agreement also ensures plasma collected in Canada is made into immunoglobulins in Canada for patients here — an approach aimed at reducing Canada’s reliance on the global market in the long term. Specifically, the agreement ensures none of the plasma collected in Canada or the immunoglobulins manufactured from that plasma by Grifols can be sold or shipped offshore. As is the practice today, this agreement is premised on Canadian Blood Services procuring finished immunoglobulins, in this case made specifically from domestically collected plasma. We will not be purchasing raw plasma.

“This is a landmark agreement for patients in Canada. It’s not about dismantling or diminishing Canada’s blood system. This agreement aligns a commercial industry leader with the national blood system to do what patients need us to do: fast-track the path Canadian Blood Services is on to improved sufficiency, protect our national blood system and ensure a domestic supply of immunoglobulins that patients in Canada can count on,” says Dr. Sher. “Establishing a domestic end-to-end supply chain speaks to a vital lesson learned from the pandemic. Once in place, it will reduce reliance on foreign sources of biologics materials and increase domestic capacity. Canadian Blood Services will continue to manage the national blood system in Canada and operate our own plasma donor centres across the country.”

The agreement responds to recommendations from the 2018 Health Canada expert panel report that advised options be carefully examined, including involvement of the commercial plasma sector, to ensure all plasma donated in Canada be made available for the needs of patients in Canada. It also addresses the Ontario Auditor General’s recommendation made in 2020 that Canada achieves 50 per cent plasma sufficiency as soon as possible. Canadian Blood Services also continues dialogue with governments to determine how, beyond this agreement, Canada should approach the expanding commercial sector with respect to meeting patient need in the country and to further mitigate impacts to the national blood supply system.

Thousands more new plasma and blood donors are needed across the country. Appointments can be booked online at blood.ca and on the GiveBlood app, or by calling 1-888-2-DONATE (1-888-236-6283).

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