From the 1970s to the early 1990s, tens of thousands of people were infected with hepatitis B, hepatitis C and HIV as a result of receiving infected blood or infected clotting factor products in the United Kingdom. Many of the products were imported from the United States, and distributed to patients by the National Health Service. Most recipients had haemophilia or had received a blood transfusion following childbirth or surgery. Around 1,250 people with bleeding disorders contracted HIV, an estimate that included approximately 380 children. More than 30,000 patients are estimated to have received contaminated blood, resulting in thousands of deaths. In July 2017, the then Prime Minister Theresa May announced an independent public inquiry into the scandal, after successive governments since the 1980s had refused to do so. The final report was published on 20 May 2024, concluding that the scandal could have been largely avoided and that "doctors, the blood services and successive governments - did not put patient safety first". Patients were knowingly exposed to "unacceptable risks" with the truth hidden from them, including by deliberate concealment.
People with haemophilia were principally infected via the plasma-derived product known as factor VIII, a processed pharmaceutical product sourced from the United States and elsewhere. The creation of these products involved dangerous plasma donation pooling manufacturing processes that led to infected products. Large groups of paid donors were used, as many as 60,000 per batch, and included prisoners and drug addicts. It only required one infected donor to contaminate an entire batch, which would then infect all recipients.
This was at a time when the practice of paying donors for whole blood in the United States had effectively ceased. The UK did not import whole blood from abroad, but it did import large quantities of factor VIII given to those infected. The UK imported these products because it did not produce enough domestically, and efforts to achieve self-sufficiency were inadequately funded. A study published in 1986 showed that 76% of those who received commercial clotting-factor products became infected with HIV, as opposed to none of those who only received the previous treatment – cryoprecipitate.
While then Prime Minister David Cameron apologised on behalf of the British government to those affected, no government, healthcare or pharmaceutical entity in the UK has formally admitted any liability in the scandal. As part of the public inquiry, 3,000 surviving victims were awarded interim compensation payments in August 2022, paid urgently due to the extremely high death rate of survivors.
On 20 May 2024, the six-year-long "Infected Blood Inquiry" was finally reported covering more than 2000 pages and describing the scandal as "the worst treatment disaster in the history of the NHS".
On the following day, 21 May 2024, the Minister for the Cabinet Office, John Glen, announced a new Infected Blood Compensation Authority to administer a new compensation scheme for victims.
Background Haemophilia is a mostly inherited genetic disorder that impairs the body's ability to clot, a process needed to stop bleeding. This results in people bleeding longer after an injury, easy bruising, and an increased risk of bleeding inside joints or other parts of the body.
Before the development of Factor VIII gene therapy, there was no long-term cure for haemophilia. Treatment and prevention of bleeding episodes is done primarily by replacing the missing blood clotting factors using "synthetic" or "non-human derived" factor products such as recombinant factor VIII. Factor products work by replacing the missing factor proteins, which can take place at home or in hospital. In the 1970s, haemophiliacs began to be treated with "factor concentrates", which were sold as a revolutionary treatment. In the 1980s, it was discovered that many of these concentrates were contaminated by hepatitis viruses and HIV. The concentrates were contaminated as a result of the way plasma was sourced and collected. The creation of these products involved dangerous manufacturing processes. Large groups of paid donors were used, as many as 60,000 per batch, and included prisoners and drug addicts.
Some of the most notorious examples of risky plasma harvesting are those of Luckner Cambronne, who became known as "The Vampire of the Caribbean" for his profiting from the sale of Haitian blood to the West for medical uses, and also Continental Pharma Cryosan Ltd, a company based in Canada that was found guilty of harvesting plasma from the bodies of dead Russians and re-labelling it as originating from Swedish donors.
Products Plasma donations could be collected using a process called plasmapheresis, before being pooled during the manufacturing process for factor VIII blood products. During the time the scandal occurred, the NHS was purchasing these blood products from commercial manufacturers and producing it themselves via the Blood Products Laboratory:
Commercial manufacturers Manufacturers that supplied clotting factor products to the UK during the mid-1970s and 1980s included Abbott (Profilate), Armour Pharmaceuticals (Factorate), Bayer-owned Cutter (Koate), Baxter International-owned Hyland (Hemofil/Interhem), Immuno (Kryobulin) and Speywood (Humanate). Abbott: The company was founded in 1888 and its initial public offering was in 1929. They received a license for Profilate in 1975. Abbott divested their Scientific Products Division, which Profilate was a part of, in 1978 to The Green Cross Corporation and Alpha Therapeutic Corporation. Armour: In 1977 Armour was purchased by Revlon for $90m. It owned the company until 1985, when it was sold to Rhône-Poulenc which purchased Revlon's drug operation for $690m. Armour and Behringwerke agreed to merge in 1995, and became Centeon. In 1999, Centeon changed its name to Aventis Behring after the parent companies, Rorer and Hoechst AG merged to become Aventis. In 2004, CSL completed its acquisition of Aventis Behring for $925m, today known as CSL Behring. Bayer: The company purchased Cutter Laboratories from Miles Laboratories in 1974. In 1978, Bayer also acquired Miles Laboratories. In 2005, a new company called Talecris was created by Cerberus Capital Management and Ampersand, which acquired Bayer's plasma business and assets for $590m. Bayer did not include its recombinant factor VIII "Kogenate" in the sale. "Kogenate" was discontinued in 2022. In 2009, CSL Limited attempted to take over Talecris for $3.1 billion, but was stopped by the Federal Trade Commission which determined that the deal would be illegal. In 2011, Grifols acquired Talecris for $4bn. Baxter: They created Travenol Labs in 1949 and acquired Hyland Labs in 1952. In 1993, Baxter was implicated in a lawsuit brought by haemophiliacs infected with HIV in the United States, with company president James Tobin resigning shortly after. In 1996 Baxter settled a lawsuit brought by haemophiliacs in Japan. In 2015, Baxter spun off its haemophilia division to create Baxalta. In 2016, Baxalta merged with Shire plc in a $32bn deal. Immuno AG: In 1976 Immuno AG sought "a licence change to allow it to supply a blood product from those paid to donate in the US rather than donors without a financial incentive in Europe". Baxter purchased Immuno AG in 1996 in an effort to keep up with competitors, for $715m. Speywood: The company became part of Beaufour Ipsen, with their name later being changed in 1998. Their Chief Scientist, between 1979-1987, provided a statement to the Infected Blood Inquiry in April 2021.
Blood Products Laboratory NHS-derived factors were produced by the Blood Products Laboratory (BPL) at Elstree, which manufactured UK blood products. The facility was unsuitable for manufacturing the volume of products needed, there were management problems and it lacked funding. As early as 1974, the Medical Research Council's blood transfusion research committee raised formal concerns that the UK transfusion services were failing to meet the blood product requirements for haemophiliacs. At a March 1979 scientific and technical committee meeting at Elstree, members formally advised the Department of Health that it was "improvident to expect the major BPL plant to continue to function much longer without major breakdown" due to a critical lack of spare production capacity.
During the July 1979 inspection of the facilities, the Medicines Inspectorate recorded that highly compromised plasma was routinely mixed with cleaner batches to "dilute the bug count out", a practice they deemed completely unacceptable. Inspectors noted structural plaster cracking with fragments breaking off into processing rooms, mould growth along the glycol lines, unmonitored cold storage freezers completely lacking temperature recording apparatus, and "openable" windows breaching an aseptic zone designated for sterilising solutions.
Conditions at Elstree continued to degrade over the following years. A follow-up inspection of March 1981 revealed extensive bio-contamination and infrastructure failures throughout the facility. The facility's sterilisation autoclaves had never been validated or commissioned. The inspection recorded that water was dripping from overhead metal panels directly onto active processing areas. Health authorities declared in September 1981 that the plant was "totally unsuitable for the manufacture of sterile products and is incapable of being upgraded to the required standards."
In September 1987, the British Medical Journal published an editorial by John Cash, the National Medical Director of the Scottish National Blood Transfusion Service, who criticised a "remarkable failure of senior civil servants and therefore politicians of all political colours" that led to years of central managerial neglect at BPL Elstree, "made possible by the strict use of crown immunity".
The 2009 Archer Report highlighted the July 1979 Medicines Inspectorate visit to BPL and concluded that if it were a commercial operation, they "would have no hesitation in recommending that manufacture should cease until the facility was upgraded to a minimum acceptable level." Rather than being closed down, the facility was kept open by relying on Crown Immunity to bypass safety regulations. These issues were later highlighted in the House of Lords by Lord Morris of Manchester, who noted from the Archer inquiry findings that "BPL was rescued by Crown Immunity" from an otherwise mandatory legal shutdown.
In 2013 the British government sold an 80% stake in the company to Bain Capital for approximately £230 million. In 2016 BPL was acquired by the Creat Group for £820m; the government stood to receive £164m from its remaining 20% share in BPL.
Hepatitis (1974–1984) The dangers of factor concentrates had been raised since their inception. In 1974, American scientist Judith Graham Pool, who previously devised the frozen blood product cryoprecipitate, a safer treatment, described the products as "dangerous" and "unethical", and warned against their use. The World Health Organization also advised the UK not to import blood from countries with a high prevalence of hepatitis, such as the United States.
In April 1975, the New England Journal of Medicine published work by Feinstone et al, that noted that "transfusion-associated hepatitis is caused by other infectious agents, not yet identified". This type of hepatitis later became known as hepatitis C. In May 1975, the World Health Organization passed a widely circulated resolution urging member states to aim at self-sufficiency in blood products that had been donated voluntarily, to enact legislation for "blood services" and to introduce measures that provide protection for donors and recipients.