Submission to Health Canada on plasma donations in Canada
Submitted July 25, 2013
Re: Public Consultation on Plasma Donations in Canada
The Registered Nurses' Association of Ontario (RNAO) is gravely concerned by the recent precipitous movement by Health Canada to support the for-profit plasma industry thereby risking the safety and integrity of Canada's blood supply system.
A decision on whether or not to approve an application can only be made based on science and fact. Health Canada is always reviewing the latest science and, to date, has seen no evidence that paying plasma donors in Canada will have a negative impact on the safety of Canada's blood supply.
While implementing advances in science and technology are crucial to public safety, it is also critical to consider evidence of public policy failure and system breakdown in order to ensure public health. It was not just a failure of science but "major systemic problems" that caused the "public health calamity" of the tainted blood scandal in Canada during the 1970's and 1980's. More than 1,000 persons in Canada were infected with HIV and tens of thousands were infected by Hepatitis C through the blood supply.
One of the systemic problems that Mr. Justice Horace Krever identified was lack of attention to the precautionary principle:
The slowness in taking appropriate measures to prevent the contamination of the blood supply was in large measure the result of the rejection, or at least the non-acceptance, of an important tenet in the philosophy of public health: action to reduce risk should not await scientific certainty. When there was reasonable evidence that serious infectious diseases could be transmitted by blood, the principal actors in the blood supply system in Canada refrained from taking essential preventive measures until causation has been proved with scientific certainty. The result was a national public health disaster.
This key lesson on the importance of the precautionary principle was reinforced by Mr. Justice Archie Campbell in his report on the Severe Acute Respiratory Syndrome (SARS) outbreak in Ontario." Campbell contrasted the handling of British Columbia's first SARS case at Vancouver General Hospital with Ontario's first SARS case at Scarborough Grace Hospital in March 2003. Acknowledging the circumstances at each institution were different, Campbell noted that SARS was "contained so effectively" at Vancouver General as they were "so steeped in the precautionary principle."
The Health Canada backgrounder gives credit to the Krever Commission's comprehensive report with its 50 recommendations as a means to "ensure a tragedy of this magnitude would never be repeated, making Canada's blood system one of the safest in the world." What is not clear in the Health Canada backgrounder or in the Summary Report is why Health Canada is rejecting the five basic principles of the Canadian blood supply system recommended by Krever. These five principles and key sections of Krever's rationale include the following:
- Blood is a public resource.
A fundamental value that must guide the blood supply system in Canada is that blood is a public resource, given altruistically by persons in Canada for the benefit of other persons in this country. Profit should not be made from the blood that is donated in Canada.
- Donors of blood and plasma should not be paid for their donations, except in rare circumstances.
Blood and plasma from unpaid donors are safer than blood and plasma from paid donors…Persons who receive money in exchange for blood and plasma donations may have an incentive to donate even when they know they should not.
- Whole blood, plasma, and platelets must be collected in sufficient quantities in Canada to meet domestic needs for blood components and blood products.
Self-sufficiency in blood products is a desirable goal…If good donor-screening measures are applied to altruistic donors, it is probable that the quality of the plasma will be superior to that obtained from remunerated donors in countries over which Canadian regulatory authority is diminished.
- Canadians should have free and universal access to blood components and blood products.
In keeping with the principles governing health care in Canada, including universality and accessibility, blood components and blood products that are essential for the health and safety of Canadians should be free to recipients.
- Safety of the blood supply system is paramount.
Preventive action should be taken when there is evidence that a potentially disease-causing agent is or may be blood borne, even when there is no evidence that recipients have been affected. If harm can occur, it should be assumed that it will occur.
In stark contrast to Health Canada's consultation materials that encourage paid plasma donations, it is the position of the World Health Organization that "the safest blood donors are voluntary, non-remunerated blood donors from low-risk populations." Arising from concerns about increasing commercial blood collection and plasmapheresis projects in developing countries linked to higher risk of disease transmission and harmful consequences to the health of too frequent blood donors, the World Health Assembly urged member states in 1975 "to promote the development of national blood services based on voluntary, non-remunerated donation of blood." This position has been reaffirmed as recently as 2009 in the Melbourne Declaration, the global consultation on 100% voluntary non-remunerated blood donation of blood and blood components, the 2010 global framework for action and the 2012 expert consensus statement on achieving self-sufficiency in safe blood and blood products, based on voluntary non-remunerated blood donation.
Blood, plasma and cellular blood components, and other therapeutic substances derived from the human body, should not be considered as mere "commodities." Donated blood that is provided voluntarily by healthy and socially committed people is a precious national resource. Governments should be accountable for ensuring a sufficient supply of products from these special resources which are and will remain limited by nature. The availability and safety of the supply, the safety of both donors and recipients and the appropriate use of blood, plasma and cellular blood donations are and must remain a public affair. The donation of whole blood or its components is an ultimate expression of community and citizen participation in the health system, which also requires effective intersectoral collaboration.
Instead of supporting commodification of human beings so that corporations can make profits, it would behoove Health Canada to revisit Krever's and the World Health Organization's understanding of blood as a precious national resource.
The Oviedo Convention on Human Rights and Biomedicine of 1997 explicitly prohibits any financial gain from the human body and its parts. Prevention of the commercialization of blood donation and exploitation of blood donors are important ethical principles on which a national blood system should be based. The right to equal opportunity in access to blood and blood products of uniform and high quality based on patients' needs is rooted in social justice and the social right to health care.
Safeguarding vulnerable people from exploitation by preventing further commercialization of blood donation is the right thing to do from a safety, scientific, and social justice perspective. Instead of seeking to expand for-profit plasma collection, Health Canada should be adhering to the precautionary principle of decreasing risk by seeking to expand Canada's own voluntary, non-remunerated donor base. RNAO agrees with Ontario's Minister of Health, Deb Matthews, who is "confident that Canadians will continue to voluntarily donate blood, plasma and platelets for altruistic reasons, rather than financial incentives."
RNAO urges Health Canada, in the strongest possible terms, NOT to grant approval for any new paid-donor blood or plasma clinics as it will risk the safety and integrity, as well as undermine the sustainability of our blood system.
Thank you for the opportunity to participate in this public consultation on behalf of Ontario's registered nurses
Doris Grinspun, RN, MSN, PhD, LLD(hon), O.ONT.
Chief Executive Officer, RNAO
Cc: Hon. Kathleen Wynne, Ontario Premier
Hon. Deb Matthews, Ontario Minister of Health and Long-Term Care
Mr. Tim Hudak, Leader, Progressive Conservatives
Ms. Andrea Horwatch, Leader, New Democratic Party