Question Period Note: Plasma collection

N/A

• Many Canadians rely on plasma and plasma products to treat life-threatening conditions. During the COVID-19 crisis, global demand, prices, and shortages have increased. The federal government recognizes that increasing domestic plasma sufficiency will help to provide security of supply. Health Canada regulates the safety of plasma collection and products made from plasma, but provinces and territories determine how plasma is collected in their jurisdictions.
• Our Government recognizes the value of domestic plasma collection for the security of Canada’s supply of plasma-derived products.
• Close federal, provincial and territorial collaboration with the national blood and plasma operator is essential to achieving meaningful results in this critical area for the health and safety of Canadians.
• Budget 2021 provided $20 million, which allows Canadian Blood Services to build six new dedicated plasma collection sites across Canada to achieve a greater domestic supply.
• Health Canada regulates the safety of plasma collection and products made from plasma, but provinces and territories determine how plasma is collected in their jurisdictions.

IF PRESSED …
• Health Canada’s role is to regulate plasma sites and to help ensure the safety and quality of the collected plasma. Under the Blood Regulations, Health Canada is required to review all submissions it receives, including those for paid plasma operations, and all plasma sites must receive HC approval in order to operate in Canada.
• Only Héma-Quebec and Canadian Blood Services are authorized to distribute plasma products in Canada. Contribution of commercially-collected plasma to Canadian plasma sufficiency is therefore dependent on commercial agreements with the blood operators. Canada has historically been dependent on foreign plasma collected from paid donors.

IF PRESSED ON CREATING A NATIONAL BAN ON PAID PLASMA DONATION…
• Provinces and territories determine how plasma is collected in their jurisdictions. Health Canada acts as the regulator in this space to help ensure the safety and quality of plasma collection and plasma products. Studies have shown that the safety of plasma and plasma products is the same whether from voluntary or paid plasma collection. It is therefore up to the provinces and territories to determine whether payment for plasma is acceptable in their jurisdictions.

IF PRESSED ON THE SAFETY OF PLASMA PRODUCTS MADE FROM PAID PLASMA…
• The safety of plasma products is the same between those made from voluntary and paid plasma; therefore, paying for plasma is not a safety issue, and is not regulated under the Food and Drugs Act.
• CBS and Héma-Quebec do not collect enough plasma from voluntary donation to create enough plasma products to meet the needs of Canadians. At present, the majority of plasma products used in Canada are manufactured from paid-plasma collected internationally. Canadian patients regularly rely on these products, which fall under the Food and Drug Regulations to help ensure they meet strict safety and quality standards.

IF PRESSED ON THE AGREEMENT BETWEEN CBS AND GRIFOLS…
• Outside of Quebec, Canadian Blood Services is the national blood authority, and on behalf of the provinces and territories, is responsible for ensuring patients in Canada have access to a safe and secure supply of blood and blood products — including plasma and medications made from plasma.

IF PRESSED ON PRAIRIESCAN SUPPORT FOR CANADIAN PLASMA RESOURCES …
• $500K in PrairiesCan funding for Canadian Plasma Resources was determined through a call for proposals and selection process within the Business Scale-up and Productivity program. This program is meant to prompt economic growth through innovation, as well as create and maintain well-paying jobs for Canadians.

Plasma-derived products (PDPs) are needed by thousands of Canadians to treat immune deficiencies, rare blood disorders, and other conditions. PDPs are manufactured from plasma through multiple processing steps designed to substantially limit the growth of pathogens. These measures significantly reduce the risk of contamination with infectious pathogens, such as viruses, bacteria, and parasites. Most plasma products used worldwide are made from paid plasma donations and collected by the commercial sector. As the federal regulator, Health Canada is responsible for maintaining the safety of Canada’s blood supply and the plasma used in the production of drugs. Any establishment that collects plasma must hold a HC authorization and license, as well as meet the strict safety requirements under the Food and Drugs Act.

Provinces and territories (PTs) determine how plasma is collected in their jurisdictions. This includes the responsibility for regulating whether the sites pay donors for their donations. While Ontario, Quebec, and British Columbia do not allow for paid plasma donations, other PTs such as Alberta, Saskatchewan, Manitoba, New Brunswick, Nova Scotia, Prince Edward Island and Newfoundland and Labrador allow plasma donors to be compensated.

The need to enhance domestic plasma collection has been a long-standing issue given Canada’s dependence on paid-donor plasma from the United States. In 2020-21, Canadian Blood Services (CBS) was only able to supply 15% of the plasma needed to make PDPs used by Canadians outside of Québec which includes the input from three new proof-of-concept plasma collection sites, opened by CBS over that year.

Québec operates its blood system, through Héma-Québec, separately from the other PTs and, in 2020-21, attained approximately 28% of domestic plasma supply.

Federal ($20M from Budget 2021) and PT investments in CBS will allow them to construct and operate a total of 11 plasma collection sites by 2024, and to reach ~25% sufficiency by 2027-28. The Budget 2021 investment in CBS provides opportunities for Canadians, including for construction of site enhancements and necessary refurbishments, as well as high quality jobs staffing the centres. The investment will also increase domestic plasma collection capacity and security of critically important therapeutics for Canadians, and has the potential to help mitigate rising healthcare costs for PTs within a decade.

In 2021-22, CBS began both a Risk-Based Decision-Making (RBDM) Analysis and a Competitive Dialogue with industry operating in the plasma collection space. The RBDM report recommended expansion of CBS collection capacity coupled with development of the plasma supply chain through commercial contracts in order to meet Canada’s needs and mitigate supply risks. Within the Competitive Dialogue, Grifols was chosen as a preferred partner, and in August 2022, a 15-year agreement was completed that will see Grifols expand widely into Canada while contributing to domestic sufficiency through CBS. The agreement with Grifols is ultimately expected to match CBS’ plasma collection capacity, creating approximately 50% domestic sufficiency. CBS also retains various controls within the agreement to ensure Grifols sites do not encroach on their own, and to ensure Grifols does not grow beyond what is agreed to by CBS, among other powers.

Grifols has fractionation capacity to be realized in Canada in the coming years (Montreal site being prepared and expected to be operational in 2024) – once this site is licensed, an end-to-end supply chain for plasma products made from Canadian plasma can be maintained domestically. Grifols also acquired Prometic Plasma Resources in Winnipeg in January 2022. Additionally, Grifols is a long-term partner with CBS for the fractionation of plasma.

In 2021, PTs established a Steering Committee for a National Policy Discussion on Plasma. The Steering Committee has representation from BC, AB, SK, ON, PEI, CBS, and Health Canada and reports to the PT Blood Liaison Committee and the Conference of Deputy Ministers of Health (CDM). Overall, PT governments, with CBS and Health Canada input, are providing expert advice to support CBS’ mandate to safeguard plasma sufficiency, and to inform PT decision-making for added investments in donor collection sites. Inputs from the process will include a PT-led stakeholder consultation, jurisdictional analysis of the CBS-led Risk-Based Decision-Making Analysis, and the CBS-led Competitive Dialogue with industry. Due to the new agreement between CBS and Grifols, PTs have decided to pause the National Policy Discussion until December and to reassess the terms of reference.

On June 29, 2022, Minister Vandal (responsible for Prairies Economic Development Canada) announced that federal funds were being provided to scale-up 11 businesses including $500K to Canadian Plasma Resources, currently the only active, independent commercial plasma collector in Canada, until such time that Grifols begins collection. Plasma collected by Canadian Plasma Resources does not contribute to domestic sufficiency.

• At the end of 2020-21, Canadian Blood Services (CBS) was only able to supply 15% of the plasma needed to make plasma-derived products used by Canadians outside of Quebec. Québec operates its blood system, through Héma-Québec, separately from the other Provinces and Territories (PTs) and has already attained a greater percentage of domestic plasma supply at 28% in 2020-21. Prior to the pandemic, PTs, except Quebec, approved three new proof-of-concept sites – CBS opened these sites in 2020-21. CBS also opened two further sites to the public, in Orleans and Brampton, ON, in Spring 2022, and is on track to open the six plasma collection sites planned with federal investments by 2024.
• In August 2022, CBS entered into a 15-year agreement with Grifols, a multi-national pharmaceutical company owning one of the largest plasma operations worldwide. Under this agreement, Grifols will only add to domestic plasma supply (i.e. no plasma products created with Canadian plasma will be sold outside Canada) while CBS can ensure new Grifols collection sites do not interfere with their own blood and plasma collection. Grifols plans to open a Montreal plasma processing facility in 2024 – once this site is licensed, an end-to-end supply chain for plasma products made from Canadian plasma can be maintained domestically. Plasma collection by Grifols is expected to double that of CBS, which would allow Canada (outside Quebec) to reach approximately 50% of domestic plasma supply by the end of the decade. At that point, CBS will still need to purchase 50% of plasma products on the global market.