Monika Dutt counsels Health Canada against changing its policy, and allowing payment to donors for blood or plasma.
Last month, after the publication of an open letter by a large group of health professional organizations and health care advocates, former Health Minister Leona Aglukkaq re-opened consultation on the contentious issue of whether Health Canada should approve clinics where people can sell their plasma to a for-profit corporation.
Canadian Doctors for Medicare – the organization I chair – attended the single, closed-door in-person consultation held by Health Canada in April, and we were left with significant questions unanswered about the safety risks associated with the clinics, whether Canada was in need of additional plasma supply, the impact of paid donations on our current voluntary system, as well as why we should change our practice to support a company profiting from Canadian plasma. It’s my opinion that Health Canada should not approve these clinics.
A distinct change in practice Canadian Plasma Resources stirred up controversy this year when it set up two for-profit clinics where donors would be paid to provide plasma, and applied for license to operate them. Given Canada’s history with tainted blood, this controversy was no surprise. In the 1980s, thousands of Canadians contracted the HIV and hepatitis C viruses – mainly from paid-donor blood that was drawn from riskier populations in the United States. An inquiry by Justice Horace Krever following the tainted blood scandals recommended that Canada should not engage in paying donors for blood or plasma, except in very rare circumstances.
This recommendation has been closely followed in Canada for the last 15 years. However, you would not know this from the Minister’s latest press release announcing the consultation, which overstates Canada’s history of paid donations: “the practice of payment for donations of plasma for the creation of plasma-derived pharmaceuticals has occurred in Canada for 30 years.”
We shouldn’t be fooled that these proposed clinics are more of the same – they would be a sharp break from existing policy. The Minister’s press release refers to the Cangene facility in Winnipeg, which is the only operation in Canada where paid donation is used, and that’s because it seeks donors with Rh-negative blood, a rare blood type, that produces antibodies for a lifesaving immune globulin medication. This is in keeping with the Krever recommendation that paid donation only be used in rare circumstances – he otherwise recommended that we do not pay donors for blood or plasma in Canada. The Minister is well aware that the Cangene facility is an exception to the rule. I would hope that our government makes policy based on rules, not exceptions.
Canada does import most of its bulk plasma products from the United States, which is derived from paid donors, but Canada does not pay donors directly, and there’s no reason to increase the amount of paid donor blood in the system. The World Health Organization has set a goal of 100% voluntary donations of blood and plasma globally, in recognition that unpaid, voluntary donors are the safest.
Canadian Plasma Resources – who’s getting the plasma? Canadian Plasma Resources has three fully functional, ready-to-operate plasma donation clinics – despite not yet having approval from Health Canada. CPR makes no secret of its plan to open 10 centres and a fractionation plant, where the plasma can be processed into medications. It’s big business – but with whom are they doing business?
We were told at the consultation by representatives of Canadian Blood Services and Health Canada that CPR does not have a contract with Canadian Blood Services to provide plasma, nor does Canadian Blood Services have a need for more plasma in the near future – our supply is currently adequate.
So the current situation is that Canadian plasma would be provided to any international bidder with whom CPR inks a deal. And Canadians would be a cheap source of plasma, at $20 a pop, to provide CPR with the raw material for drugs like IVIG, which cost thousands of dollars per treatment. What’s more, plasma donors can donate every week, unlike blood donors, who must wait about two months between donations.
Safety risks and the impact on voluntary donations Although Health Canada is responsible for evaluating the safety and regulatory aspects of Canadian Plasma Resources, it has not examined the impact of these for-profit facilities on our voluntary blood and plasma donation system. We do not know what impact paid donation will have on donors who would otherwise contribute to Canadian Blood Services.
Health Canada also does not consider the location of these facilities, though one is located next to a homeless shelter, and the other next to a drug treatment clinic. Choosing these locations brings up many ethical and public health concerns, including targeting people who may be living in poverty, as well as drawing blood and plasma donations from a population who are at a higher risk of having infectious diseases. While blood screening techniques post-Krever have improved dramatically, we cannot know what the next blood-borne pathogen might be, and we should exercise caution with respect to safety. After all, HIV was once an unknown blood-borne virus too.
As we hurtle toward what seems like a foregone approval of these clinics, we’re left wondering, what public policy goal is met by this fundamental shift in practice? Why would Canada change the safe course it has steered since the Krever inquiry in order to respond to business interests that won’t necessarily address our domestic supply of plasma?
I urge the new Health Minister, Rona Ambrose, and Health Canada not to approve these clinics without a full, frank, open dialogue with Canadians, and a clear public policy rationale for the change. I hope other Canadians will do the same by contacting the Minister.
This opinion piece was initially posted on July 22, 2013 on healthydebate. It is reposted here with permission of the author.