Health Canada “consultation” on paid plasma less than adequate

The issue of paid plasma donations in Canada has taken a new development.

It didn’t take long between the publishing of our joint letter in the Hill Times and the decision by Health Canada to solicit input on the question of paid plasma donations.

Health Canada finally released its report yesterday on the April roundtable in Toronto, doing its best to shoot down concerns raised by those hand-selected by them to participate in that meeting. Despite our national profile and research on this issue, OPSEU was denied an invitation.

However, Health Canada was happy to have the Plasma Protein Therapeutics Association there. The PPTA is an industry lobby group whose mission is, among others, to break down “artificial barriers on trade and compensated donors.”

While 28 organizations had called for a comprehensive national consultation, what we are now getting is no more than a blank invitation to write to Health Canada on the issue before July 26. There is no indication whether the submissions will be made public, read, or whether they will be simply collected as evidence that a consultation had taken place. The consultation process is not highlighted on Health Canada’s website and is very difficult to find.

Given a month to prepare submissions in the dead of summer, it tells us Health Canada really doesn’t care about effective consultation. Our notification didn’t come from Health Canada – despite our subscription to their website and prior contact over this issue. Instead it came from our colleagues at Canadian Doctors for Medicare, who were able to attend the April roundtable.

Presentations by both Health Canada and Canadian Blood Services (CBS) at the earlier invitation-only meeting emphasized that contrary to cautions expressed by the World Health Organization, that paid donations were safe and necessary given shortages of plasma for pharmaceutical use.

CBS and Health Canada don’t see the irony in telling us that the present technology can screen out any virus, while at the same time telling us that the private for-profit Canadian Plasma Resources, the company at the centre of this controversy, will be required to do diligent screening of individuals selling their plasma.

If they are so confident of the technology being foolproof, why do screening at all?

Nowhere in the roundtable report does CBS admit that they contributed to that plasma shortage by closing down their last dedicated volunteer plasma collection centre in April 2012. That centre was producing more than 10,000 units of plasma per year in Thunder Bay. CBS also closed down another blood distribution centre last year in Saint John, New Brunswick.

Instead CBS CEO Graham Sher told the roundtable that Canada couldn’t possibly be self-sufficient in volunteer donated plasma to meet our plasma-based pharmaceutical needs. It does get especially difficult when you close down existing collection sites.

Forty-one of 151 countries belonging to the World Health Organization report producing all or part of plasma-derived medicinal products through the fractionation of plasma collected in the country.

Sher says we would need to raise between 600,000 and 700,000 litres of plasma for fractionation in order for Canada to become self-sufficient, yet Canadian Plasma Resources says we are already collecting 20 per cent.

Despite Sher’s claim that it would be impossible, Canadian Plasma Resources says that it intends to make us self-sufficient by eventually operating 10 paid donation centres that will achieve a production rate of 400,000 litres annually (not the 600,000 to 700,000 litres Sher says is required).

Let’s not forget that the provinces did at one point set a target to increase domestic supply of plasma for fractionation after access was disrupted from the United States in the late 1990s. This occurred after U.S. FDA raised quality concerns about its own output by US fractionators. This is the same process CBS and Health Canada have always maintained is entirely safe.

At the time the head of the US FDA had this to say: “FDA believes that the plasma industry also needs to act more aggressively to comply with GMP (good manufacturing processes) while maintaining adequate production to meet medical demands.” Good manufacturing process? This hardly sounds foolproof to us.

Self-sufficiency in blood and blood products was supposed to be our goal. To hear CBS speak about it, you’d think they’d never heard of the World Health Assembly resolution (WHA63.12) that urges all Member States (including Canada) to develop national blood systems based on voluntary non-remunerated blood donation and work towards the goal of self-sufficiency. It didn’t come up at all in the roundtable report.

For all the warnings about shortages, Health Canada and CBS are content that either an international supply will always be there for them, or that a Canadian licensed private for-profit company will sell to them rather than to the highest bidders in a globally competitive market.

Canadian Plasma Resources states in its own surprisingly frank submission that “the increase in demand can lead to instability in the supply and much higher import costs.”

Are they actually claiming they wouldn’t respond to these higher world prices in a market-based environment where demand for plasma is high? The cost of IVIG is already skyrocketing, leading some analysts to question whether shortages are being manipulated to generate higher revenues.

Canadian Plasma Resources says their long term goal is to open the first fractionation plant in Canada – effectively giving them a near monopoly position here with regards to the collection and processing of plasma into pharmaceutical products. With 10 collection sites the private company will also dwarf plasma collections for transfusion by CBS. Yet CBS continues to remain unconcerned.

Canadian Plasma Resources goes as far as stating that they can work collaboratively with Canadian Blood Services in diverting people with blood types in high demand, during blood shortages suggest people forego their $20 and walk over the CBS instead, or work jointly to strategize on joint donor recruitment and retention of donors. When you are looking for a license, there is a lot of motivation to be public spirited.

Last summer CBS told us they wanted nothing to do with the private company – at least for now.

Both CBS and Canadian Plasma Resources do admit one thing – opening up a network of for-profit donor centres across Canada will have an impact on the blood supply.

The private company estimates that impact to be 6.6 per cent based on US data. CBS estimates it to be closer to 8 per cent. Nobody knows for sure. Either way, it means CBS will have to work harder to maintain the status quo.

CBS says that paid donations offered by Winnipeg’s Cangene BioPharma has had no impact on volunteer CBS blood donations in that city, although Cangene is a speck in the ocean compared to the scale of operation Canadian Plasma Resources has planned. Cangene is also very specialized. They are specifically looking for donors with a rare blood type – Rh-negative – which is used to produce antibodies for Rh immune globulin. No wonder it has little to no effect on CBS’ Winnipeg donations.

Cangene recently sold off its other plasma collection sites in the United States and is now purchasing plasma on the open market for the rest of its pharmaceutical products.

CBS and Health Canada are using the small-scale and niche plasma collections by Cangene to suggest what is being proposed by Canadian Plasma Resources is normal.

The fact that they would deliberately do this should leave every Canadian wondering about the credibility of both public organizations on this issue.

Similarly on the issue of ethics, both CBS and Health Canada appear to argue that since Cangene has been doing this for some time, as have other countries, it must therefore be ethical.

We would strongly recommend both organizations seek to recruit from the nation’s schools of philosophy if they think this makes any sense.

The reality is a large-scale paid plasma donation system will prey on the poor and those high risk populations desperately in need of a $20 paid trip to Canadian Plasma Resources. Much has already been made of the fact that one of the company’s two Toronto paid donation centres is adjacent to a homeless shelter. Both are located near public universities to attract a student clientele.

Remarkably, the roundtable report – prepared by a contract company employed by Health Canada – throws doubt on whether a paid donor base would be more of a risk than a volunteer one.

The contract reporter states: “The safety concerns were more hypothetical in nature. The fear was that providing payment for blood donations would introduce a perceived risk in the system because it would incentivize low-income, high risk groups to ‘sell’ their plasma for fast cash. This fear is centered on the belief that unpaid volunteers donating blood and plasma for altruistic reasons are less motivated to lie about health issues on screening tests. Whether or not this is the case…”

Are they kidding? Whether or not this is the case? This from the U.S. FDA: “FDA agrees that the data presented demonstrate that the paid and unpaid donor populations, whose plasma is used for manufacture of fractionated products, have different viral marker rates.” Could the evidence get any clearer?

The fact that the private company doing the reporting feels the need to put ‘sell’ in quotations in reference to paid donations tells us everything we need to know about bias.

If you trade something for money, generally in our society we call that selling.

Remarkably, there are no national rules around paid donations. After defending paid donation, Health Canada appears to pass the buck on this issue, suggesting it is up to the provinces to decide. Quebec is the only province with an outright ban on paid blood donations.

Justice Krever, who investigated Canada’s last tainted blood scandal in the 1990s, recommended Canada maintain an open and transparent blood system and consult with the public before changing the volunteer system.

It may not be law, but clearly it has been practice. With the exception of the tiny niche paid donation by Winnipeg’s Cangene, Canada has maintained a voluntary system for blood donations.

As much as CBS and Health Canada want to pretend this is nothing out of the ordinary, it is a major shift and deserves more than a month for interested parties to send an e-mail or write a letter.

If you do want to send an e-mail expressing your opinion by July 26, please do so at this address: BGTD.OPIC@hc-sc.gc.ca

You can also fax your submission to (613) 952-5364 or send them your thoughts by Canada Post at this impossibly long address: Office of Policy and International Collaboration
, Biologics and Genetic Therapies Directorate
 – Health Products and Food Branch 
Health, 0702B
 – 200 Tunney’s Pasture Driveway, 
Ottawa, Ontario K1A 0K9
, Canada

To read Health Canada’s biased roundtable report, click here.

More on this to come, including Canadian Blood Services selective reading of the Dublin Accord (or almost Accord).