In the late 1970s to 1980s, Canada was faced with a public health crisis, in which the national blood supply was contaminated with two infectious viruses, human immunodeficiency virus (HIV) and hepatitis C. The viruses were transmitted through both transfusion of blood components (red cells, platelets and plasma) and blood products (factor concentrates). More than 1,000 people were infected with HIV, some of whom unknowingly infected others, and over 10,000 people were infected with hepatitis C. At that time contracting HIV, which causes acquired immune deficiency syndrome (AIDS), was fatal.

AIDS symptoms were first identified in homosexual men in 1981, but less then a year later the same symptoms were found in several hemophiliacs who had no homosexual behaviour. The discovery of AIDs in hemophiliacs turned the focus to assessing the blood system. It wasn’t until 1984 that HIV was identified, and a test was developed to detect its presence.

On December 14, 1989, the Government of Canada announced that it would provide $120,000 to persons infected with HIV through blood components or products. However, in the early 1990s many infected with HIV had already died, and many who received blood transfusions in the 80s were still learning that they had been infected with HIV. The growing recognition of the extent and gravity of the tainted blood supply began to raise questions and concerns about a similar event occurring in the future. This led to the federal, provincial and territorial ministers of health (except Quebec) recommending a public inquiry on the blood system in Canada on September 16th, 1993.

Justice Horace Krever was appointed as the Commissioner of the inquiry. Over a period of two years (1993 – 1995) Justice Krever heard testimonial from 400 witnesses and approximately 175,000 documents were submitted for review. Testimony was heard from various provincial authorities and health officials, as well as individuals who had been infected, or affected, by the contamination in the blood system.

The final report provides an extensive analysis of the history of Canada’s blood system and provides significant details on the events leading to the tainted blood crisis. Briefly, in the early 1970s there was a growing concern about the possibility that commercial fractionators (companies who created blood products) were buying plasma from persons in developing countries irrespective of their state of health. Inquiries by the World Health Organization (WHO) confirmed that there existed an extensive trade in human blood, and in 1975 the WHO passed a resolution that urged its member states to promote national blood services that were based on voluntary non-remunerated donation. The WHO hoped that the resolution would lead to more countries becoming self-sufficient and therefore decrease the incentive for commercial firms to pay persons in developing countries for their plasma.

At the time of the blood taint crisis in Canada, the Canadian Red Cross was running a national non-profit blood transfusion service and several for-profit companies also operated in Canada to fractionate blood to create products. Connaught Laboratories Limited (Connaught), one of the main for-profit companies who sold blood products, was a key player in the events leading to the crisis. Connaught was actually founded in 1914 by the University of Toronto, and initially its operations were supported by the sale of products that it made and sold on a not-for-profit basis. For more then 25 years Connaught was able to finance its operations from the revenue generated by the sale of products it made, but by the early 1970’s it was no longer able to do so due to the expense needed to upgrade its facilities. So in 1972 Connaught was sold to the Canada Development Corporation, becoming a for-profit corporation. Up to the late 70s, Red Cross had a cooperative relationship with Connaught, whereby blood which was not used in hospitals was given to Connaught to be separated into its plasma components. The blood products were then provided to the Red Cross for distribution. Thus, the reality was that Connaught was using un-paid donor blood to create blood products which it would then sell.

However, in the late 70s and early 80s, tensions rose between Connaught and Red Cross as they began to compete for government funding to upgrade their facilities. Neither organization received funding for the necessary upgrades, which meant that Canada was not able to be self-sufficient in blood products. Justice Krever noted that this was “not an unusual situation; few countries have been able to meet their domestic demand for fresh frozen plasma through voluntary donations, and most have had to depend on the purchase of concentrates made from plasma obtained from persons who were paid.” [i]

Unable to meet demand, both Connaught and Red Cross began to buy from American commercial distributors. Unfortunately, at that time in the United States plasma was regularly collected from prisons and other paid donors who would be considered at risk of contracting disease (i.e. intravenous drug users). The United States Food and Drug Administration also did not regulate the manufacture and sale of the blood products at that time. The American companies failed to inform the Canadian organizations of their practices, and the Canadian organizations for their part failed to ensure that appropriate practices were in place. As a result of these multifaceted problems, the tainted blood from these American commercial distributors was unknowingly provided to Canadians leading to the crisis.

In the final report Justice Krever provided 50 recommendations for the improvement of the blood system moving forward. As part of his recommendations, Justice Krever outlined five principles that the Canadian blood supply system should be governed by:

1. Blood is a public resource

2. Donors of blood and plasma should not be paid for their donations, except in rare circumstances.

3. Whole blood, plasma, and platelets must be collected in sufficient quantities in Canada to meet domestic needs for blood components and blood products.

4. Canadians should have free and universal access to blood components and blood products.

5. Safety of the blood supply system is paramount.

The principles recognize that altruism is a fundamental value which underpins Canadian health care and tissue donations. The theory at play in these recommendations is that a well-informed, altruistic donor would not donate if there is a possibility that their blood will do harm, as compared to persons who receive money, who therefore may have incentive to donate even when they know they should not. However, the principles also allow for the recognition that in some cases, the collection of plasma for specialized blood products may require an offer of compensation. In the report it was noted that there are companies which already exist, like Rh Institute in Manitoba, which depend upon providing payments to donors with rare blood types. Thus, the Commissioner states that “[d]espite the policy of gratuitous donations, it may be necessary to offer compensation to these persons for their time and effort in order to attract a sufficient number of donors.”[ii]

The key recommendation made by Justice Krever was for the creation of a national system for the collection and delivery of blood components and products. The majority of recommendations made in the report are focused on outlining the operation and management of a national system. This of course later led to the creation of the Canadian Blood Services.

Regarding plasma collection specifically, Justice Krever recommended that the national operator of the blood supply system (ie Canadian Blood Services) need not operate its own fractionation plant (used to create blood products). Yet he did recommend that:

Canadian plasma should be custom fractionated, in batches consisting only of Canadian plasma, based on specifications negotiated between the fractionator and the national blood service. These specifications should include requirements for the manufacture of the safest and the highest-quality products. [emphasis added] [iii]

This is tied to another recommendation, which is that an effort needs to be made to ensure that blood components and products used in Canada continue to be made from blood and plasma collected from unpaid donors. As was noted, at the time of the blood taint crisis a for-profit company, Connaught, was working with Red Cross to fractionate (or process) blood which had come from unpaid donors. Justice Krever did recommend that no profit be made from blood but did not appear to take direct issue with the relationship between a not for profit organization working with a for-profit company.

The report is based on knowledge that existed in 1997. Justice Krever acknowledged that “it is therefore essential to emphasize that our knowledge of these two organisms was and is still evolving”.[iv] Thus, to appropriately understand what was recommended by Krever, one must understand the circumstances in which the recommendations were made. Today, with the creation of legislation which prevent the sale of blood or blood constituents (ie Voluntary Blood Donation Act), a number of provincial governments have argued that the legislation upholds the recommendations made in the Krever Report. However, arguably, such legislation picks and chooses which recommendations to follow, and fails to understand the whole of the circumstances which led to the blood taint scandal. While Justice Krever did recommend that efforts be made to uphold Canada’s altruistic, unpaid donor system, he also recognized that there are circumstances where donors may need to be paid, as well as recommending that Canada make efforts to be self-sufficient in its blood product needs, and use only blood products made from Canadian donors.

According to Canadian Blood Services, to date, the majority of plasma protein products used in Canada still come from paid donors in the United States. However, it is quite clear today that the safety of blood products from paid plasma donors is no different than unpaid donors. Thus, as science and technology have advanced over the past 20 years, it is perhaps necessary to reassess how much dependence is put upon the Krever Report recommendations.

References

[i] Commission of Inquiry on the Blood System in Canada: Final Report, vol 1 (Ottawa: Public Works and Government Services Canada, 1997) at page 50 [Krever]. [online: publications.gc.ca/collections/Collection/CP32-62-3-1997-1E.pdf ]

[ii] See Krever volume 3 at 1062.

[iii] See Krever volume 3 at 1051.

[iv] See Krever volume 1 at page 33.