The tainted blood disaster, or the tainted blood scandal, was a Canadian public health crisis in the 1980s in which thousands of people were exposed to HIV and hepatitis C through contaminated blood products. It became apparent that inadequately-screened blood, often coming from high-risk populations, was entering the system through blood transfusions.[1][2] It is now considered to be the largest single (preventable) public health disaster in the history of Canada.[3]
The Commission of Inquiry on the Blood System in Canada, more commonly referred to as the Krever Commission or Krever Inquiry, was a royal commission of inquiry into the tainted blood scandal, investigating how the Canadian Red Cross and the provincial and federal governments allowed contaminated blood into the healthcare system.[1]
Established by the Canadian Government in October 1993 and headed by Justice Horace Krever, the Krever Commission is one of the most high-profile public inquiries in Canadian history and is seen as bringing the scandal into the public eye.[2][4][5]
Over 30,000 Canadians were infected with hepatitis C between 1980 and 1990 and approximately 2,000 Canadians were infected with HIV between 1980 and 1985.[5][6] Around 8,000 of those who received tainted blood died or are expected to die as a result.[6][3] Some blood products were also sent abroad, infecting people in Japan, Germany, and Britain.[7]
Background and crisis
Since the 1940s, blood supply in Canada had largely been the responsibility of the Canadian Red Cross Society. This independent charitable body supplied donated blood to hospitals or, if the blood was past its expiry date, gave it to Connaught Laboratories, the major producer of blood products in Canada. Connaught had initially been a non-profit company operated by the University of Toronto; by the 1980s it had been sold into the private sector. The Canadian Red Cross set the standards for health and safety in the collection, testing, storage, and distribution of blood and its components until 1989.[8]
In 1981, the Canadian Blood Committee was created by the provincial ministers of health and funded the Red Cross's blood transfusion service.[8]
In 1984, some major blood banks in the United States began to use a new test, called surrogate testing, to screen blood for hepatitis B, an indicator of HIV. However, the Canadian Red Cross did not follow suit. It was not until 1985 that the Red Cross began screening and testing donated blood for HIV; meantime, another virus made its way into the blood system: Hepatitis C.[5]
In November 1985, the Canadian Red Cross Society began testing all donated blood for the presence of the antibody associated with HIV. In 1986 and 1987, though Factor VIII concentrate was heat-treated to kill HIV, the treatment was faulty and seven children were infected. The Canadian Hemophilia Society demanded the product be pulled, but the Red Cross refused.[9] According to one estimate, about 133 cases of HIV transmission via blood products took place between March and November 1985.[1] Moreover, a test to screen blood for hepatitis C was made available in 1986, but the Red Cross did not begin using it on donated blood until 1990.[1] As of December 1989, around 1,250 Canadians, many of them hemophiliacs, were known to have contracted HIV through blood products.[1]
Once the extent of the infection of the tragedy was known, the Red Cross failed to track down those who had received tainted blood so that they could receive treatment and avoid passing on the viruses to others.[6]
Inquiry
In November 1992, a parliamentary committee called the Commons Sub-Committee on Health Issues began to examine the tainted blood scandal. In May 1993, having heard from over 30 witnesses, the Committee recommended a full-scale inquiry.[10] Likewise, on 16 September 1993, the federal, provincial, and territorial ministers of health, except for the Minister of Health of Quebec, recommended that a public inquiry be established.[11] That month, the Government of Canada announced a full-scale, CA$2.5-million inquiry into the tainted-blood crisis.[1][10]
Order in Council PC 1993-1879 was issued on 4 October 1993, and the Commission of Inquiry on the Blood System in Canada was issued on October 27, appointing Justice Horace Krever as chair.[11]
The goal of the inquiry was "to review and report on the mandate, organization, management, operations, financing and regulation of all activities of the blood system in Canada, including the events surrounding the contamination of the blood system in Canada in the early 1980s." This was to be achieved by examining "the organization and effectiveness of past and current systems designed to supply blood and blood products in Canada; the roles, views, and ideas of relevant interest groups; and the structures and experiences of other countries, especially those with comparable federal systems."[10][11]
The Commission would end up fighting various pitched legal battles with federal government, mainly over its right to name publicly those who had failed in their duties. In the process, the Commission redefined the role of public inquiries in Canada.[6]
Hearings
Preliminary and public hearings in the inquiry took over 2 years. The Commission heard from 474 people and 89 written submissions.
Organizational hearings were held in Ottawa, Ontario, on 22 and 23 November 1993. At those hearings the following parties received standing:[11]:6
nine organizations, including the Canadian Hemophilia Society and the Canadian AIDS Society, that represented persons who had been infected with HIV or hepatitis C by blood, blood components, or blood products, and other persons interested in the contamination of the blood supply in the 1980s.
The first phase of public hearings was conducted between February and December 1994 in every province except Prince Edward Island, for which evidence was heard in Halifax, Nova Scotia. In addition to infected persons or members of their families, those who testified in this phase included employees of local Red Cross blood centres, provincial government officials, and representatives of community and AIDS-related organizations; in total, 315 witnesses testified during the first phase of public hearings.[11]:7
The second phase of public hearings addressed broader national concerns regarding the historical actions and relationships of the participants in the Canadian blood system. These hearings took place in Toronto, Ontario, between March and November 1995, equating to over 100 days of hearings with 84 witnesses testifying in total.[11]:7
The third phase of public hearings addressed the organization of the blood system current to the time. In this phase, which took place in Toronto during November and December 1995, round-table discussions were held on issues affecting the blood system; case studies were conducted with the cooperation of the major organizations in the system (the Canadian Red Cross Society, the Canadian Blood Agency, the Government of Canada, the Canadian Hemophilia Society, and the Association of Hemophilia Clinic Directors of Canada) to examine what changes had been made to their decision-making processes since the 1980s; and presentations were made by the major organizations regarding the current blood system.[11]:7
Report and fallout
In 1989, the Government of Canada provided CA$120,000 in "humanitarian assistance" to victims of tainted blood in exchange for a guarantee that they would not sue. In 1993, the provinces extended the compensation plan, offering $30,000 annually to all those who had contracted the AIDS virus from blood.[6]
In April 1996, the provincial and federal ministers of health met to begin the reform of the Canadian blood system, agreeing that a safe, integrated, accountable, and transparent national blood system was needed.[1]
The Krever Commission tabled its report in the House of Commons on 26 November 1997. It estimated that 85% of the 30,000 hepatitis C infections from blood transfusions between 1986 and 1990 could have been prevented.[5] Krever concluded that the Canadian government failed to take precautionary screening and testing measures to protect Canada's blood supply. The inquiry also uncovered cost-cutting attempts, which favoured for-profit paid-plasma schemes; cover-ups; and widespread political interference; as well as negligent importation of blood collected from high-risk American donors.[3]
The Report suggested that the Canadian blood system should be governed by 5 principles:[1]
Canada should collect enough blood and components to satisfy its own needs;
citizens should have free and universal access to blood components and products; and
safety of the blood supply is paramount.
The new system, Canadian Blood Services, began operations in September 1998, replacing the Canadian Blood Agency (formerly the Canadian Blood Commission), which was disbanded as result of the inquiry. However, the province of Quebec did not agree to be part of a national blood system. Instead, it set up its own parallel provincial service, Héma-Québec. Both agencies would operate at arm's length from the federal government.[1]
The Report also made recommendations regarding no-fault compensation for persons who had received contaminated blood.[1] On 27 March 1998, Health Minister Allan Rock held a press conference to release details about the federal government’s compensation package, only offering compensation to victims who were infected between 1986 and 1990.[5]
The fallout from the scandal also led to the restructuring of the Bureau of Biologics, the division of Health Canada that was responsible for monitoring blood safety.[6]
Less than a month after the Krever Report was released, the RCMP launched a five-year investigation into the tainted blood disaster. In 2002, the RCMP laid 32 charges in total against two senior bureaucrats at Health Canada, the head of the Red Cross' blood program, and a vice-president of Armour Pharmaceutical, a New Jersey company that manufactures Factor VIII concentrate for use by hemophiliacs. The company itself was also charged, as was the Canadian Red Cross Society.[9]
On 30 May 2005, the Red Cross pleaded guilty to violating the Food and Drug Regulation Act by distributing an adulterated or contaminated drug. It was fined $5,000, which was the maximum penalty for the offence under the Act. The criminal charges were dropped.[9]
On 25 July 2006, the Canadian government announced a nearly $1-billion compensation package for 5,500 people—the "forgotten victims" who contracted hepatitis C before January 1, 1986 and after July 1, 1990.[5][13]
The crisis and subsequent scandal has led to nearly $10 billion in legal claims.[6]
A blood-borne disease is a disease that can be spread through contamination by blood and other body fluids. Blood can contain pathogens of various types, chief among which are microorganisms, like bacteria and parasites, and non-living infectious agents such as viruses. Three blood-borne pathogens in particular, all viruses, are cited as of primary concern to health workers by the CDC-NIOSH: HIV, hepatitis B (HVB), & hepatitis C (HVC).
The Canadian Red Cross Society is a Canadian humanitarian charitable organization, and one of 192 national Red Cross and Red Crescent societies. The organization receives funding from both private donations and from Canadian government departments.
Health Management Associates is a defunct Arkansas-based company involved in a blood-management scandal during the 1980s.
The Irish Blood Transfusion Service (IBTS), or Seirbhís Fuilaistriúcháin na hÉireann in Irish, was established in Ireland as the Blood Transfusion Service Board (BTSB) by the Blood Transfusion Service Board (Establishment) Order, 1965. It took its current name in April 2000 by Statutory Instrument issued by the Minister for Health and Children to whom it is responsible. The Service provides blood and blood products for humans.
Factor 8: The Arkansas Prison Blood Scandal is a feature-length documentary by Arkansas filmmaker and investigative journalist, Kelly Duda. Through interviews and the presentation of documents and footage, Duda alleges that in the 1970s and 1980s, the Arkansas prison system profited from selling blood plasma from inmates infected with viral hepatitis and HIV. The documentary contends that thousands of victims who received transfusions of blood products derived from these plasma products, Factor VIII, died as a result.
Kelly Duda is an American filmmaker and activist from Arkansas best known for the 2005 documentary, Factor 8: The Arkansas Prison Blood Scandal.
Contaminated hemophilia blood products were a serious public health problem in the late 1970s up to 1985.
In April 1991, the doctor and journalist Anne-Marie Casteret published an article in the French weekly magazine the L'Événement du jeudi showing that the Centre National de Transfusion Sanguine knowingly distributed blood products contaminated with HIV to haemophiliacs in 1984 and 1985, leading to an outbreak of HIV/AIDS and hepatitis C in numerous countries. It is estimated that 6,000 to 10,000 haemophiliacs were infected in the United States alone. In France, 4,700 people were infected, and over 300 died. Other impacted countries include Canada, Iran, Iraq, Ireland, Italy, Japan, Portugal, and the United Kingdom.
The HIV-Tainted Blood Case is a Supreme Court of Japan case that resulted in a landmark decision regarding criminal responsibility for administrative negligence. The Court upheld the conviction of Akihito Matsumura, former director of the biologics division of the old Health and Welfare Ministry, for his failure to prevent the use of HIV-contaminated blood products in the 1980s that resulted in the death of a patient. According to the two lower court rulings, Matsumura caused the death of a patient with liver disease in December 1995 by failing to stop the use of unheated blood products contaminated with HIV. The decision marks the first time that a government official has been held criminally responsible for administrative negligence. The decision finalized a verdict of 1 year in prison, suspended for two years, for Matsumura.
The contaminated blood scandal, also known as the infected blood scandal, was a British medical scandal in which a large number of people were infected with hepatitis C and HIV, as a result of receiving contaminated blood or contaminated clotting factor products. Many of the products were imported from the US, and distributed to patients by the National Health Service throughout the 1970s and 1980s. Most recipients had haemophilia or had received a blood transfusion following childbirth or surgery. It was estimated that more than 30,000 patients had received contaminated blood, resulting in the deaths of at least 3,000 people. In July 2017, Prime Minister Theresa May announced an independent public inquiry into the scandal, and its findings are due to be reported in May 2024.
Patrick McGuire is a Scottish solicitor and solicitor advocate. He is a partner with personal injury law firm Thompsons Solicitors Scotland.
The Penrose Inquiry was the public inquiry into hepatitis C and HIV infections from NHS Scotland treatment with blood and blood products such as factor VIII, often used by people with haemophilia. The event is often called the Tainted Blood Scandal or Contaminated Blood Scandal.
Arthur Leslie Bloom FCRP, FRCPath (1930–1992) was a Welsh physician focused on the field of Haemophilia.
Charles Rocco Carmine Rizza FRCPEd was a British consultant physician who specialised in haematology.
R (March) v Secretary of State for Health was a 2010 judicial review which challenged the UK Department of Health's decision not to implement Recommendation 6(h) of the Archer Independent Inquiry. The case was important in developing the doctrine of error of fact in public law which previously had not readily been the subject of judicial intervention.
The Advisory Committee on the Virological Safety of Blood, often abbreviated to ACVSB, was a committee formed in March 1989 in the United Kingdom to devise policy and advise ministers and the Department of Health on the safety of blood with respect to viral infections. The scope of the ACVSB concerned areas of significant policy for the whole of the United Kingdom and operated under the terms of reference: "To advise the Health Departments of the UK on measures to ensure the virological safety of blood, whilst maintaining adequate supplies of appropriate quality for both immediate use and for plasma processing." Of particular emphasis to the remit was the testing of blood donors using surrogate markers for Non-A Non-B hepatitis (NANBH) and later on, HCV-screening of blood donors.
The HIV Haemophilia Litigation [1990] 41 BMLR 171, [1990] 140 NLJR 1349 (CA), [1989] E N. 2111, also known as AMcG002, and HHL, was a legal claim by 962 plaintiffs, mainly haemophiliacs, who were infected with HIV as a result of having been treated with blood products in the late 1970s and early 1980s. The first central defendants were the then Department of Health, with other defendants being the Licensing Authority of the time, (MCA), the CSM, the CBLA, and the regional health authorities of England and Wales. In total, there were 220 defendants in the action.
CN v Secretary of State for Health and Social Care [2022] EWCA Civ 86 was an appeal against the refusal of permission to apply for judicial review to challenge the infected blood support scheme administered by the NHS Business Services Authority (NHSBSA) for non-inclusion of those infected with chronic Hepatitis B virus. The appeal was based on the grounds that the exclusion of those infected with HBV from the England Infected Blood Support Scheme (EIBSS) was unreasonable and discriminatory, contrary to article 14 when read in conjunction with article 8 and article 1 protocol 1 (A1P1) of the ECHR. The appellant also claimed that there was different treatment and that the failure to include those infected with HBV was unreasonable, and that the original application for review should not have been deemed out of time.
In 1994, the Irish Blood Transfusion Service Board (BTSB) informed the Minister for Health that a blood product they had distributed in 1977 for the treatment of pregnant mothers had been contaminated with the hepatitis C virus. Following a report by an expert group, it was discovered that the BTSB had produced and distributed a second infected batch in 1991. The Government established a Tribunal of Inquiry to establish the facts of the case and also agreed to establish a tribunal for the compensation of victims but seemed to frustrate and delay the applications of these, in some cases terminally, ill women.
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