A commercial blood plasma collector’s entrance to Canada means big business and big questions

Open this photo in gallery:

A deal between Canadian Blood Services and a private blood-plasma collector marks a major expansion of the commercial plasma industry in Canada – an industry that provides life-saving medicine, but also brings with it a host of ethical questions.

The agreement with Barcelona-based pharmaceutical company Grifols, announced last month, is one of the most significant changes in years at Canadian Blood Services (CBS), a national charity that administers Canada’s blood supply in all provinces except Quebec. For the first time, CBS – which was founded on the principle of voluntary blood donations – will work hand in hand with a private company that pays Canadians for their raw plasma.

For more than two decades, CBS has purchased finished plasma products made by Grifols, but the new deal profoundly changes the parameters of CBS’s relationship with the company.

Many questions remained unanswered, however, such as why Grifols was chosen for the contract, why CBS changed its stand on commercial plasma collection and how the agency will oversee the ethics of its partner’s business model. CBS has not released the financial details of the 15-year deal, nor specifics about how it will work with Grifols other than saying that the agreement allows it to veto locations of Grifols collection centres that it feels would have an impact on its own collection efforts, which will continue.

In the past, CBS’s primary concern has been that private centres that pay for donations would siphon donors from public centres that do not pay. That worry is part of why the practice has been banned in three provinces: Ontario, Quebec and British Columbia. (The bans in Ontario and B.C. contain clauses that may allow an exception for Grifols, though the provinces have not confirmed they would allow it.)

Even before the deal was announced, Grifols had been working with CBS behind the scenes. CBS has contracted the company to act as a consultant on its plasma strategy, such as where to put collection centres and how to run them, according to Peter Jaworski, a professor of business ethics at Georgetown University who studies the plasma industry.

Picard: Is paying for plasma unprincipled?

Opinion: Paying for blood-plasma donations is the answer to our shortages

CBS’s 2020-2021 annual report says they contracted a manufacturer to advise on collection strategy but doesn’t name which one. When asked if that company was Grifols, CBS chief executive Graham Sher would only say he has consulted with multiple non-profits and companies over the years.

CBS collects enough plasma for transfusions but gets only about 15 per cent of the plasma it needs to produce immunoglobulin, which is used to treat people with compromised immune systems from cancer treatment, autoimmune disorders or other reasons. CBS does not manufacture its own immunoglobulin but sends the plasma to companies, including Grifols, that use it to make plasma products and ship them back.

The demand for immunoglobulin has been rising in Canada and other countries for years. The U.S. Food and Drug Administration declared a shortage in 2019, the same year that CBS warned of low supply of a take-home version of the drug. Health authorities, including CBS and Héma-Québec, the province’s blood-collection agency, have recommended doctors use less to constrain demand, but they have also sought ways to boost supply.

Grifols’s Canadian footprint started in 2020, with the US$400-million purchase of a manufacturing facility in Montreal. On Jan. 4 of this year, the company also announced it had purchased a private collection centre in Winnipeg.

The Winnipeg centre, once owned by Cangene, was for many years the only plasma collection centre in Canada that paid donors; this plasma was used to produce a specialized product. The only other private collector in Canada, Canadian Plasma Resources (CPR), opened its first centre in 2016 and now operates in four provinces. It ships its plasma to international manufacturers, including German company Biotest AG, which was bought by Grifols last year. CBS has declined to buy plasma directly from CPR, but the agency has not answered questions about its reasons for this decision.

CBS conducted a risk analysis in 2021 and 2022 about its options to expand plasma collection and settled on working with a private partner. In the summer of 2022, the agency solicited bids from companies and chose Grifols as the winner.

Grifols’s deal with CBS is part of its international expansion plan. Plasma-industry analyst Matthew Hotchko said Grifols differs from its main rivals – Australia’s CSL and Japan’s Takeda – in the way it has aggressively pursued government partnerships. Its first public-private partnership launched in Egypt in 2020. This summer, in response to European Union consultations on blood and plasma policy, Grifols urged the EU to require member states to develop national plasma strategies that focus on boosting supply.

Grifols says its goal in partnering with governments is to increase their self-sufficiencies in plasma medicine, said Mary Hughes, vice-president of biopharma sales and commercial operations for Grifols Canada, in a statement.

But the deal with CBS does not have controls on possibly the most ethically sensitive part of the business: how much it pays donors. Grifols “is an independent entity,” Dr. Sher said. “They will operate according to their model.”

That model relies on creating financial incentives that keep donors coming back frequently.

At the collection centre in Winnipeg, donors are paid up to $100 for each of the first six times they donate plasma. After that, the rate becomes $35, or $55 for another visit within a week. If someone donates six times in a month, they get a $50 bonus.

Those rates are, however, lower than what a donor would make in the U.S., according to Dr. Hotchko. He said his data show the average price of first-time donations is between US$100 to US$120, later settling to between US$45 to US$65. He said donor compensation is usually about 40 per cent of the companies’ per-litre cost.

Dr. Hotchko said a fundamental reason for the lower Canadian prices is market dynamics. In U.S. cities where multiple plasma collectors operate, they have to raise their fees to compete for donors. With fewer companies operating in Canada, “there won’t be so much competition and donation fees won’t have to be very high,” he said.

In a presentation to investors earlier this year, Grifols said it finds donors by targeting young people and those in financial difficulty. A 2021 study by U.S. researchers found the typical plasma donor was younger than 35, had a low credit score and likely made less than US$20,000 a year. In fact, the researchers said, plasma donation became a substitute for predatory lending: When a collection centre opened in a neighbourhood, donors there were 18-per-cent less likely to take on a payday loan.

Commercial plasma-collection companies have come under some scrutiny for their practices. Last year, the Biden administration in the U.S. directed border officials to block plasma donors in Mexico from crossing the border into Texas to donate at Grifols and CSL facilities.

The two companies fought the order in court and, at one point, argued the Mexican donors should be considered couriers of their plasma. U.S. District Judge Tanya Chutkan responded that “a person is more than just a shopping cart of biological products to be bought and sold at a later date.” However, the judge ultimately sided with the companies by issuing a preliminary injunction on Sept. 16 on the grounds the government hadn’t fully justified its order.

But concern over financial vulnerability of donors is not a reason to ban pay, University of Toronto bioethicist Eric Mathison argues. Instead, the concern should be the amount of compensation and whether donors are being paid fairly. “If exploitation is a concern, the solution is to require companies to pay more,” he said.

CBS has said that, from an ethical standpoint, the overriding goal should be to ensure there is enough supply of plasma products to meet the needs of patients.

Most patient groups, many of which receive funding from pharmaceutical companies, have been positive about the deal.

Whitney Goulstone, executive director of the Canadian Immunodeficiencies Patient Organization, said the reality is that private companies have more money to direct at the problem for building up the plasma supply, and non-profits like CBS should take advantage of that.

“I do know not-for-profit has a lot of amazing ideas and people there who are very engaged,” she said. “But the business world, the for-profit world, is where all the resources are.”