Scottish Infected Blood Inquiry

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BLOOD SAFETY IN SCOTLAND

The Scottish Infected Blood Inquiry (Penrose Inquiry) was a Scottish Public Inquiry into Hepatitis C/HIV infections acquired from NHS treatment in Scotland with blood, under the Inquiries Act 2005 , chaired by the Rt Hon Lord Penrose in January 2009. Its Preliminary Report was published in September 2010 and a Final Report on 25 March 2015. . The Full Report and the referenced documents can be accessed from

The great majority of people who were infected by the viruses responsible for AIDS and/or hepatitis C received treatment with blood or blood products before the viruses responsible had been discovered. Those affected included people with haemophilia and patients transfused with red bloods platelets, plasma or cryoprecipitate. . Several investigations of hepatitis in blood recipients preceded the Penrose Inquiry.

● Scottish Executive Investigation into Hepatitis C (2000)

In August 1999, the Scottish Executive investigated hepatitis C and heat treatment of blood products for people with haemophilia, following a claim by the the Haemophilia Society) that the Scottish National Blood Transfusion Service (SNBTS) had delayed heat treating its Factor VIII ( treatment for haemophilia A) to prevent infection with hepatitis C. The investigation also examined the extent to which the risks of treatment had been explained to patients.Written evidence was taken from the SNBTS, the Haemophilia Society and from individual patients and their families. Meetings were also held with the Haemophilia Society and Directors of Haemophilia Centres in Scotland.

The report of the investigation was published in October 2000: none of the allegations made against the SNBTS, nor haemophilia doctors, were upheld. The investigation concluded that “SNBTS made very reasonable progress in developing products with reduced viral risk, relative to activity elsewhere.”

Scottish Parliament Investigation into Hepatitis C (2001)

The Health & Community Care Committee (HCCC) of the Scottish Parliament examined further allegations made by the Scottish Haemophilia Forum and the Haemophilia Society. The HCCC endorsed the findings of the Scottish Executive Investigation but also advised the Scottish Government to considered awarding no-fault compensation to people infected with hepatitis C by blood products.

Expert Group on Financial and Other Support (2003)

In response to the recommendation from the HCCC (2001), the Scottish Executive established an Expert Group under to consider “…the circumstances in which a system of financial and other support might be available to people who have been harmed by NHS treatment in Scotland in circumstances in which there is unlikely to be liability on the part of NHS Scotland-.” This group recommended payments to people with haemophilia who were infected with hepatitis C on the grounds that recipients of blood products who had been infected with HIV had previously been awarded ex-gratia payments under the Macfarlane and EileenTrusts .As a result the Skipton Fund was set up in 2004.

Investigation by the Crown Office and Procurator Fiscal Service (2005).

Applications were submitted to the Crown Office and Procurator Fiscal Service by Thompsons Solicitors for Fatal Accident Inquiries to be carried out into the deaths of Eileen O’Hara and David Black, both of whom had died from hepatitis C after receiving treatment with blood products. The Lord Advocate of Scotland decided not to seek Fatal Accident Inquiries into either of these deaths.

Scottish Parliament Investigation into Hepatitis C (2006)

The Health and Community Care Committee of the Scottish Parliament reconsidered the topic of hepatitis C infection via blood products in 2006. The Scottish Haemophilia Forum, some individual patients and a Solicitor representing patients claiming to have been infected with hepatitis C via NHS treatment were invited by the HCCC to make written and oral submissions.. The HCCC decided: “to ask the Scottish  Executive to establish an independent judicial inquiry examining the treatment of people infected with hepatitis C through NHS treatment and examining the “look-back” procedure employed to trace them.” Thisreccomendation was rejected by the Healt Minister

Judicial Review (2008)

The decision of the Lord Advocate not to hold Fatal Accident Inquiries and the decision of Scottish Ministers not to hold an independent judicial inquiry were subjected to judicial review in a case brought by Thompsons Solicitors on behalf of the relatives of two patients,citing Article 2 of the European Convention on Human Rights. Defendants in the case were the Scottish Government and the Lord Advocate. Counsel for the Scottish Government chose not to contest the medical allegations and argued instead that Article 2 of the European Convention on Human Rights did not apply to the deaths in question.

The presiding judge, found in favour of the Petitioners and “reached the conclusion that the only means by which a practical and effective investigation into the death of either Mrs. O'Hara or Mr. Black could be achieved would be if the State were to initiate a public inquiry. That could be done by the Lord Advocate seeking the holding of a Fatal Accident Inquiry before a Sheriff or by the Scottish Ministers setting up a public inquiry under the provisions of the Inquiries Act 2005".

THE SCOTTISH INFECTED BLOOD INQUIRY (THE PENROSE INQUIRY)

Review of documentary and witness evidence

The Scotish Government chose to hold a public inquiry under the Inquiries Act (2005), announced on 23 April 2008, into infections with HIV and HCV. .Its terms of Reference covered all aspects of the production and supply of blood products for patients in Scotland, the information given to patients about risks of treatment, and the review of data about the numbers of patients affected. The Inquiry examined around 118,000 documents. Written statements were provide by 159 patients or relatives. Oral evidence was taken over a period of 89 days, both in public from witnesses and experts and in closed sessions in which 15 patients or relatives, gave evidence anonymously.Written and oral evidence was obtained from 52 persons with involvement in blood and blood products and in patient care. Many of these gave evidence on several occasions.

Preliminary Report

Published in September 2010, its 614 pages contain a comprehensive review of relevant medical and scientific knowledge providing the Final Report of the Inquiry.

Final Report

The Final Report of the Penrose Inquiry (1,824 pages) was published on 25 March 2018. The 2,000 referenced   referenced documents can be accessed from There are 5 volumes:1. Patient’s Experiences, 2. Knowledge of HIV/AIDS and Hepatitis C ,3 Blood and Blood Products,4. Donor Selection and Screening of Donated Blood , and 5.Information to Patients .

The key findings are:

Volume 1: Patients’ Experiences

few aspects in which matters could or should have been handled differently.

delay in the introduction of screening for Hepatitis C.

AIDS, all that could reasonably be done, was done. they held up well wne compared to other countries.”

The often forgotten suffering of clinical staff, who were to discover that the treatments they thought were beneficial to patients actually caused them to become infected with life-threatening conditions. This is the stuff of nightmares, and they too have suffered, especially when accused of knowing or deliberate attempts to harm patients.

One doctor eloquently described his experience of prescribing the new concentrate products which offered so much to patients with haemophilia only to discover the threat of AIDS as, 'waves of hope, followed by waves of despair'. Patients and doctors shared this experience.

Chapter 1

“Untreated, haemophilia has always been, and remains, a serious, debilitating and potentially fatal disease.” and that

Without treatment we know that life expectancy is very limited.

The Birch report in the 1930s disclosed that only 20% of patients with severe Haemophilia could expect to live beyond twenty years.

“Mild haemophilia does not imply mild bleeding….death from bleeding could very easily take place.”

(b). The Inquiry determined that 478 patients with bleeding disorders were thought to have been infected with HCV in Scotland, of whom 193 have died, 21 from a liver-related cause. 60 patients with bleeding disorders were infected with HIV, of whom 39 have died. The Inquiry further estimated that 2500 individuals other than those with haemophilia were infected with HCV by transfusion of blood components (in distinction from fractionated plasma products)  and at least 18 with HIV.

(c). Statements were provided by 159 patients and relatives, 13 of whom gave oral evidence. “…the Inquiry heard many tales of truly extraordinary bravery in the face of adversity. There were also tales of resignation and tales of rage. For all patients and relatives the consequences of infection were at least distressing, for many they were devastating and, for some, tragic.”

Investigation of Individual Deaths

Four deaths relating to HCV infection were investigated; Eileen O’Hara  and David Black, to comply with the ruling of the Judicial Review, The cases of Alexander Black Laing and Victor Tamburrini were  added by Scottish Ministers.

Thompsons Solicitors Scotland sought to also have the death of Robert Brand included, as this case (ref – The Herald, 11 February 2006) had been central to their presentation to the Scottish Parliament Health and Community Care Committee in 2006. The case was not selected, as Robert Brand had not been infected directly by a blood product but via his wife Agnes Brand, who believed that she has been infected with hepatitis C via a blood transfusion. Thompsons filed for a Judicial Review of the decision to exclude this case from the Penrose Inquiry, but abandoned the Judicial Review when it was  established that Agnes Brand had not received a blood transfusion.

(a) Eileen O’Hara

The Inquiry did not support the claims made at the Judicial Review (2008). The cause of infection was not identified but, based on expert medical evidence on the natural history of hepatitis C, the Inquiry concluded that Eileen O’Hara was most probably infected by a transfusion in 1979, at a time when infection with HCV “could not have been prevented.”

(b) David Black

The Inquiry did not support the claims made at the Judicial Review (2008). The exact cause of infection was not identified, but the Inquiry decided that David Black was most probably infected with hepatitis C by haemophilia therapy in Scotland in the 1960’s, although infection via treatment in the USA in 1970 (which had not been disclosed in evidence to the Judicial Review) was not ruled out. The Inquiry concluded “Infection was inevitable given (his) requirements for factor replacement therapy” and “there were no reasonable precautions that might have avoided death.”

(c) Alexander Black Laing

Alexander Black Laing was infected with hepatitis C by a transfusion in 1990 . His case had been identified by the SNBTS hepatitis C look-back. (Final Report of the Penrose Inquiry, paragraph 7.236). Although transfused prior to the introduction of donor screening in Scotland, the Inquiry found that hepatitis C infection could not have been detected with any of the tests available at the time because of the genotype of HCV involved; similarly, the infection was found not to be detectable by surrogate tests for non-A ,non-B Hepatitis. “The Inquiry was not, therefore, able to identify any precautions whereby (his) death could have been avoided.”

(d) Victor Tamburrini

In the case of Victor Tamburrini, the Inquiry “established beyond reasonable doubt” that his hepatitis C infection was not a result of treatment with blood or blood products.

Volume 2: Knowledge of HIV/AIDS and Hepatitis C

(a). In respect of HIV/AIDS, the Inquiry examined the development of knowledge of the syndrome, concluding “…the concentrated effort made within a very short time to deal with the problem presented by its sudden and unanticipated appearance are particularly remarkable.” In its examination of the debate surrounding the cause of AIDS, the Inquiry concluded “The scientists responsible for cutting edge research and technological progress were convinced at an early stage of the viral aetiology of AIDS and were largely untouched by the debate.”

(b). In respect of developing knowledge concerning non-A, non-B Hepatitis, the Inquiry concluded “There was no generally accept view prior to 1985 that NANB Hepatitis had other than a generally benign prognosis…..From 1985 it became increasingly understood that NANB Hepatitis infection could be associated with serious disease…..”

Volume 3: Blood and Blood Products

(a). With regard to the supply of blood products, the Inquiry concluded “Scottish production of concentrates largely met the demands of haemophilia clinicians for NHS factor products” and  “..it is somewhat surprising that Scottish needs were as well catered for as, in the event, they proved to be.”

With regard to the use of commercial products the Inquiry concluded “The NHS in Scotland could not have restricted import and use of commercial products once they were licensed. That was a function of the UK Government.”

The Inquiry also concluded “Nothing could have been done to prevent the provision of blood and blood products infected with NANB Hepatitis in the 1970s and early 1980s or, when it emerged HTLV III/HIV.”

and “There is no criticism that can be legitimately made of the practice in relation to the use of factor concentrates over this period.”

(b). With regard to the development of virus inactivated factor concentrates by the SNBTS, the Inquiry stated:

“It was the ability of Scottish scientists to pursue their own research that resulted in the development of effective heat inactivation at the end of 1984, enabling the SNBTS to provide the first comprehensive national supply of heat treated Factor VIII in the world.”

“In general, was the approach taken to viral inactivation at the Protein Fractionation Centre in the period 1980-84 reasonable? In general, was the degree of priority accorded to viral inactivation by the Protein Fractionation Centre during this period reasonable? These two questions relate to the work of the scientists explored in the evidence narrated in this chapter. They can be answered unequivocally in the affirmative.”

“….a safe NHS product was available many years before commercial manufacturers supplied Factor IX concentrates that were safe from the transmission of NANB Hepatitis/HCV.”

“There is no basis for adverse criticism of the PFC and its scientists over the period ending with the introduction of Z8 [a Factor VIII concentrate] for routine clinical use in April 1987. On the contrary, they achieved outstanding results, as evidenced by the fact that Scotland appears to have been the first country in the world that was able to supply all of its haemophilia patients with a Factor VIII product that did not transmit Hepatitis C.”

“…the evidence available to the Inquiry was uniformly to the effect that liaison between the organisations [PFC in Scotland and PFL/BPL in England] was effective in ensuring that researchers in Scotland were aware of significant developments in England…”

“The UK as a whole, and for the present purposes Scotland in particular, were fortunate indeed in benefiting from the relationships among the scientists engaged in their respective research projects in virus inactivation….”

Volume 4: Donor Selection and Screening of Donated Blood

(a). In considering the collection of blood in prisons, the Inquiry noted “It is unfortunate that consideration was not given by Scottish Transfusion Directors, collectively, as to the appropriateness of continuing with prison collection prior to the matter being raised by the Medicines Inspectorate in 1982……however, it cannot be said that they are likely to have decided to stop collecting in prisons or that it was unreasonable for the practice to have continued until the early 1980s.” and “…in the absence of any instruction or direction from government in Scotland, it cannot be said that the Scottish Regional Transfusion Directors acted unreasonably in continuing to collect blood from prisons until the early 1980s. In addition, given the variation in practice in transfusion regions in England and Wales and in other European countries, it cannot be said that the practice in Scotland in the 1970s and early 1980s to collect blood from penal institutions was out of step with generally accepted practice elsewhere.”

(b). With regard to collecting blood from US military personnel, the Inquiry concluded

“ …there is no support in the evidence before the Inquiry for the suggestion that American service personnel presented a higher risk of transmitting HCV (or indeed HIV) than the general Scottish or UK donor population.”

(c). After considering the issues surrounding decisions not to introduce surrogate testing of donated blood for NANB Hepatitis, the report states “There was no consistent support for the procedure on tenable scientific or medical grounds that would have made it possible to conclude that officials should have recommended the introduction of ALT testing, or that the question was so narrowly balanced that it required to be referred to ministers for decision.”

(d). In respect of donor selection and AIDS, with particular reference to the provision of advice to donors, the Inquiry noted “…much that happened in Scotland, then and later, was as a result of Dr McClelland’s efforts. His views were remarkably prescient and it is appropriate to recognise in this Report that, insofar as progress towards an acceptable solution was made, the credit is due to him.” and  “…in the view of the Inquiry, there was nothing more that could have been done that would have improved the situation.”

(e). The Inquiry also examined the introduction of screening of donated blood for HIV, noting “The production of screening tests for antibodies to HIV in 1984 and 1985 involved research and development work, in the USA, in France and in England, that was carried out with remarkable expedition and commendable success.”, concluding “There is no legitimate ground for criticism of the processes adopted for the introduction of anti-HIV screening that can be founded on delay. It was achieved as soon as was reasonably practicable.”

(f). With regard to the screening of donated blood for hepatitis C the Inquiry concluded “a decision to recommend to Ministers the introduction of routine screening of blood donations for anti-HCV could and should have been taken [by the Advisory Committee on the Virological Safety of Blood, [ACVSB]  by the middle of May 1990. It appears unlikely; however, that screening in any centre could have started much before the autumn of 1990. Having regard to the supplies of test kits available.”

However, with regard to the ACVSB, the Inquiry cautioned “There is therefore no basis on which individual members of the committee or officials in attendance can be criticised in relation to the workings of the committee, and no observation made or conclusion reached by the Inquiry should be understood as making any such criticism.”

“The Inquiry also examined the issue of why it took 10 months after the decision in principle had been taken for screening to actually start…….The Gulf War was an unexpected development, and accounted for some of the delay at this time. There were also unresolved issues in England and Wales as to how screening was to be funded. Against this background, the policy of a uniform start date throughout the UK was not altered.” In this respect the Inquiry noted “….earlier introduction of screening in Scotland……..would have required the responsible Minister in Scotland to have departed from the policy of a uniform start date across the UK. It is not certain that that would have happened, but the Secretary of State for Scotland and his Ministers should have been alerted to the situation in order that they could take a decision as to the most appropriate course of action.”

Volume 5: Information to Patients

(a). In examining the systems in place for informing patients of risk the Inquiry concluded that “…best practice now in relation to informed consent and even in the sharing of information differs from the practices which prevailed during the reference period, or at least up until 1988 when the influence of HIV/AIDS helped to bring about significant changes…….It must be acknowledged that this will not bring consolation to the many patients and relatives troubled by what they see as a lack of informed consent or a lack of information….”

(b). The Inquiry also examined investigations of immune abnormalities in patients with bleeding disorders, noting “Its labelling as ‘AIDS study’ has increased concern. There have been suggestions that it involved experimentation on patients. During the hearings it was acknowledged on behalf of patients, relatives and the Haemophilia Society that there was no factual basis for this suspicion, and the Inquiry reached the view that any such suspicion was without foundation. The Inquiry concludes that it was in the best interests of patients to conduct such studies of immune function.”

(c). In the communication of test results to patients, the Inquiry noted “…in relation to the test procedures adopted for testing patients’ samples for HTLV-III and the communication of test results, there was no breach in Edinburgh or Glasgow of any rule or principle of ethical conduct then applicable.”

(d). With regard to hepatitis C look-back, “The Inquiry answers in the negative the question of whether the rest of Scotland should have initiated look-back earlier than it did. In relation to the exercise required, the Edinburgh region had logistical advantages over the rest of Scotland. Further, although interferon was thought to be a candidate for treatment from October 1993, there were doubts about its efficacy and it was not licensed for use until November 1994. It is not possible to conclude that an earlier decision on UK-wide or Scottish policy could have been reached. The exercise across the UK was described to the Inquiry as one of the earliest comprehensive look-backs instituted in the world.”

Recommendation of the Inquiry

The Inquiry made one recommendation “That the Scottish Government takes all reasonable steps to offer an HCV test to everyone in Scotland who had a blood transfusion before September 1991 and who has not been tested for HCV.”

The warning letter process was carried out in strict confidence but took over 12 months to complete. This long period may have helped to foster a view that the Penrose Inquiry would find significant fault and wrong-doing. The expectation of significant fault being found may have been a factor in the large attendance of patients and relatives from throughout the UK at the presentation of the Final Report. An apology  from Prime Minister David Cameron,  reported before publication of the Final Report may also have contributed to  the rapid and widely reported characterisation of the Report as a “whitewash” before it could have been studied..

Warning Letters and Aftermath

Prior to publication of the Final Report, Lord Penrose was required under the Inquiries Act (2005) to issue warning letters to anyone facing significant or explicit criticism.

It was generally assumed that warnings letters were only issued to those facing criticism by the Inquiry. However, the Inquiries Act (2005) does not specify “by the Inquiry”. Lord Penrose made no assumptions and applied the Inquiries Act literally. Explaining the selection of recipients of warning letters in the Foreword to his Report he stated: “This included not just criticisms made by the Inquiry but also those made of individuals in evidence, if repeated in the Report.”

COST OF THE PENROSE INQUIRY

Section 39 of the Inquiries Act (2005) requires that the full costs of an inquiry be published by the minister responsible. Costs incurred directly by the Inquiry totalled £12,123,755 and are published in the website of the Penrose Inquiry.

Additional costs of £1,140,059 were incurred by the Scottish Government to meet legal costs incurred by the NHS in Scotland and by the Scottish Government (ref- Scottish Government Freedom of Information response FoI/15/01926, 11 January 2016). The addition of these indirect costs brings the total cost of the Penrose Inquiry to £13,263,813.

Legal Costs

● Legal representation for patients and families

● Counsel for the Inquiry

● Inquiry Paralegal Team

● Legal representation for the NHS in Scotland

●Legal representation for the Scottish Government

Total Legal Costs

£1,902,633

£1,839,192

£1,409,992

£775,334

£364,725

£6,291,876

Inquiry Team

● Fees for the chairman and staff salaries

£3,342,622

Expert Input

● Cost of Inquiry Assessor and medical experts

£730,493

Professional Services

● Cost of document management, specialist IT support and media/PR support.

£977,036

Oral Hearings

● Rental of venue and associated costs

●Technology for court reporting systems

●Witness expenses

£808,304

Accommodation and Administration

● Cost of running the Inquiry’s offices

●All administrative costs, including publication and dissemination of reports.

£1,113,482

TOTAL COST OF THE PENROSE INQUIRY

£13,263,813.

References

• "Terms of Reference". www.penroseinquiry.org.uk. This article incorporates text from this source, which is under Crown copyright

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