Final Report

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Chapter 1


1.1 This is the Final Report of the Inquiry into the transmission of blood-borne viruses to people in Scotland in the course of medical treatment provided by the NHS. The viruses, HIV and Hepatitis C, cause life-threatening illness. Some of those who became ill following infection with one or both of these viruses died as a result, and others continue to live with serious ill-health. Why and how that occurred has been investigated in depth by the Inquiry and the results of that investigation are set out in full in this Report. A summary version of the Report is available separately.

Origins of the Inquiry

1.2 On 18 April 2006, the Health Committee of the Scottish Parliament called for a Public Inquiry into the infection of people with Hepatitis C from NHS treatment. The then Scottish Executive decided not to hold an Inquiry, but the Scottish National Party made a commitment in its 2007 manifesto to hold such an Inquiry if elected to form the government in Scotland.

1.3 Separately, the personal representatives of Reverend David Black and Mrs Eileen O'Hara, two individuals who appeared to have acquired Hepatitis C from NHS treatment with blood or blood products in Scotland and who had since died, raised proceedings in the Court of Session to challenge decisions not to conduct investigations into those deaths. The challenges were successful, the court taking the view that, under Article 2 of the European Convention on Human Rights, the applicants were entitled to an independent Inquiry into the deaths of their relatives.

1.4 On 23 April 2008, the then Deputy First Minister and Cabinet Secretary for Health and Wellbeing, Nicola Sturgeon MSP, announced to the Scottish Parliament that there would be a judicially led Public Inquiry, under section 28 of the Inquiries Act 2005, into the transmission of Hepatitis C and HIV from blood and blood products to National Health Service patients in Scotland. She informed Parliament that the Rt. Hon. Lady Cosgrove would chair the Inquiry. Lady Cosgrove subsequently withdrew for family reasons. The Inquiry was set up as the Penrose Inquiry on 13 January 2009 with 12 Terms of Reference.

Terms of Reference

1.5 The Terms of Reference required the Inquiry to investigate the deaths of named individuals who were thought to have acquired Hepatitis C from treatment with blood or blood products and, more generally, to investigate how patients in Scotland acquired HIV or Hepatitis C from blood or blood products, and the consequences of such infection. An amendment to the Terms of Reference was announced in November 2009 to include three additional deaths which were to be investigated and a further amendment to them was made in February 2011 to remove one of those individuals from the investigation. The Terms of Reference, as amended, are as follows:

  1. To investigate the systems in place in Scotland for the collection, treatment, licensing, testing, preparation for supply and supply for use by the NHS of blood and blood products with particular reference to the risks of transmission of the Hepatitis C virus and HIV to patients treated by the NHS in Scotland, including the role of government in regulation and setting guidelines and standards.
  2. To investigate the systems in place for informing patients treated by the NHS in Scotland of the risks associated with the use in their treatment of blood or blood products, with particular reference to the risks of infection with the Hepatitis C virus and HIV.
  3. To investigate the systems in place in Scotland for obtaining consent from, and testing for infection with Hepatitis C and HIV, patients treated with blood or blood products, and informing any patients found to be so infected.
  4. To investigate the systems for recording and monitoring the numbers of NHS patients in Scotland treated with blood and blood products, with particular reference to the numbers exposed to risk of infection with the Hepatitis C virus and HIV and the numbers contracting either or both such infections as a consequence of such treatment.
  5. To examine the circumstances generally in which patients treated by the NHS in Scotland became infected with Hepatitis C, HIV, or both through the use of blood or blood products in the course of their treatment, taking account of the development of scientific and clinical understanding and evidence internationally.
  6. To investigate the deaths of Reverend David Black, Mrs Eileen O'Hara, Alexander Black Laing and Victor Tamburrini, with particular reference to the circumstances in which they became infected with the Hepatitis C virus, HIV or both.
  7. To investigate the steps taken by those involved in, and those responsible for, the NHS in Scotland, including NHS Boards and the Scottish National Blood Transfusion Service (SNBTS), their officers and employees and associated agencies, once Hepatitis C and HIV were identified, to trace individuals who might have become infected with one or both of them as a result of receiving blood or blood products; and to identify any other or further steps that might reasonably have been taken to trace such individuals.
  8. To investigate the steps taken by those involved in, and those responsible for, the NHS in Scotland including NHS Boards and SNBTS, their officers and employees and associated agencies, to prevent the provision of infected blood and blood products.
  9. To investigate the steps taken by those involved in, and those responsible for, the NHS in Scotland including NHS Boards and the SNBTS, their officers, employees and associated agencies to inform individuals who might have received infected blood or blood products of the risks associated with their treatment for themselves and their families; and to offer treatment to any individual at risk, and to identify any other or further steps that might reasonably have been taken to inform and to treat such individuals.
  10. To examine any particular adverse consequences for patients treated by the NHS in Scotland and their families of infection through blood and blood products with Hepatitis C and HIV, including the treatment offered.
  11. To identify any lessons and implications for the future, and make recommendations.
  12. To report as soon as practicable.

1.6 The period scrutinised by the Inquiry began on 1 January 1974, although in many respects, it was necessary to make some study of earlier events in order to provide context for the principal examination. The period ended on 1 September 1991, when screening of donated blood for the Hepatitis C virus was introduced throughout the UK. As occurred with the commencement date, it was not possible to adhere to a fixed point for termination of the period investigated. Some parts of the Report therefore make reference to events after 1991, in order to explain the outcome in relation to specific aspects of the investigation.

Work of the Inquiry

1.7 The Inquiry discharged its remit in four stages: gathering information and documents and familiarisation of the Inquiry Team with the issues; preparing, and publishing in September 2010, a Preliminary Report setting out the evidential background to the matters covered in the Terms of Reference; hearings in relation to defined topics; and the writing and publication of this Final Report. It was recognised that additional factual material was likely to emerge during the hearings stage of the Inquiry's work, and so it proved; in consequence of this, a fuller factual background is set out in this Report, with references to the Preliminary Report where appropriate.

1.8 The selection of topics for oral hearings was made following research carried out by the Inquiry Team up to, and including, the writing of the Preliminary Report. The process whereby a virus was transmitted from donor to recipient offered several stages at which infection could have been prevented: selection of blood donors; screening of donations for viral infection; treatment of blood products (although not whole blood) to destroy viruses present; and the approach adopted to use of blood and blood products in the treatment of individuals. The extent of information communicated to patients about the hazards of treatment, primarily before treatment was given but also after it had occurred, was also an important part of the story. The topics selected for exploration at hearings reflected all these aspects. They are listed in Appendix 1.

Oral hearings

1.9 The hearings took place between 8 March 2011 and 30 March 2012. The presentation of evidence was led by the team of Counsel to the Inquiry. Counsel representing (i) patients, families and the Haemophilia Society; (ii) National Health Service interests and (iii) the Scottish Government were also present throughout, and able to question witnesses. Evidence was led from 67 witnesses, and 120,000 documents were introduced. Submissions were made by Counsel during the hearings, on various matters, and closing submissions were presented by those listed in (i) to (iii) above.

1.10 It will be obvious that the period into which the Inquiry was conducting its examination was more than 20 years ago. This inevitably affected the quality of recollections. Some key witnesses had died. On the other hand, the database assembled by the Inquiry held many thousands of documents, and it was frequently possible to reconstruct events from a combination of written material and the testimony of those involved. Where the Inquiry has not found it possible to resolve questions of fact, that is stated in the Report. These instances are few.

1.11 The approach adopted, of examining individual topics, meant that certain key NHS personnel had to attend to give evidence on more than one occasion. Two clinicians attended on 10 occasions each. Every witness who testified, whether physician or lay person, will have experienced inconvenience and a degree of stress. The Inquiry was and is aware of this, and is grateful for the contribution made by all those concerned.

Warning letters

1.12 During the final stage of the Inquiry's work, it was necessary to prepare and send warning letters in accordance with Rule 12 of the Inquiries (Scotland) Rules 2007. Rule 12(7) provides:

The inquiry ... must not include any significant or explicit criticism of a person in the report ... unless -

(a) the chairman has sent that person a warning letter; and

(b) the person has been given a reasonable opportunity to respond to the warning letter.

1.13 To comply with this Rule, it was necessary to send 103 warning letters. One hundred replies were received, running to over 1000 pages of material. The points made in these responses were considered by the Chairman and his team and, in some instances, changes were made to draft text of the Report in order to reflect points that were considered well-founded.

Structure of Final Report

Part one

1.14 The first part of the Report gives an indication of the patients primarily at risk of viral infection from blood and blood products, and covers the effects of Hepatitis C or AIDS, or both conditions, and their treatment, on patients and their families. As Term of Reference 4 required the Inquiry to investigate the numbers of patients exposed to the risk of contracting either or both conditions through treatment with blood and blood products and the numbers who actually contracted the conditions, Chapter 3 entitled Statistics provides the results of that investigation. Part one also contains a chapter concerned with the investigation of the deaths of certain named individuals which, in consequence of Term of Reference 6, the Inquiry was specifically required to investigate (see Chapter 7).

Part two

1.15 The second part of the Report deals with knowledge, past and present, of HIV/AIDS, covering its aetiology, geographical spread, prevalence, and the response to it in clinical practice. This part of the Report is also concerned with knowledge of viral hepatitis, as at the beginning of the reference period and from 1975 until the present day.

Part three

1.16 The third part of the Report provides information on blood collection and the production of blood products, including details of the management of such activities and the facilities relating to collection and production. It also provides information on haemophilia therapy, including the use of blood products, up until 1987. Finally, it contains chapters on the viral inactivation of blood products for such therapy up until 1987.

Part four

1.17 The fourth part of the Report considers the discovery of HIV and the development of screening tests for it; screening of donated blood for, respectively, Hepatitis B, C and HIV; donor selection; and surrogate testing of donated blood for what was then known as non-A, non-B Hepatitis, later recognised as largely due to Hepatitis C.

Part five

1.18 The fifth part of the Report is devoted to a consideration of the information given to, or withheld from, patients by the medical profession, and the ethical principles governing the provision of, or withholding of, such information at the relevant time and currently. The relevant information concerned, primarily, the risks of HIV/AIDS and Hepatitis C and patients' test results. This section of the Report also covers 'look-back', the Inquiry's investigation into the steps taken to identify individuals infected by HCV as a result of treatment with blood donated prior to HCV screening. A glossary is also contained in this part of the Report.


1.19 The Report has five appendices. Appendix 1 details the processes followed by the Inquiry, including the governing law and the specific procedures adopted, and outlines the Core Participants and how they were selected. Appendix 2 covers Inquiry organisation and administration, including the provision of IT for the preparatory phase and for the hearings, and the processing of documents. Appendix 3 details the individuals and organisations which were designated as Core Participant. Appendix 4 lists the witnesses who gave evidence at the oral hearings. Appendix 5 gives details of all the Inquiry Procedure Directions, Guidance Notes and Restriction Orders which were issued during the course of the Inquiry.


1.20 There were four groups of people in Scotland affected by this tragedy: those who acquired the Hepatitis C virus (HCV) from blood transfusion; those who acquired HCV from treatment for bleeding disorders; those who acquired HIV from blood transfusion; and those who acquired HIV from treatment for bleeding disorders. As the Report explains, the risks which materialised in relation to individuals in these groups do not now exist in the same way. Donated blood is screened for HIV and HCV, and blood products used in the treatment of bleeding disorders are artificially synthesised and do not pose a risk of transmission of blood-borne viruses.

1.21 Owing to the significant changes which have taken place, it was not necessary for the Inquiry to identify measures required to prevent recurrence of infection with HIV and HCV through blood transfusion or therapy for bleeding disorders. The primary focus for the Inquiry's work was retrospective: posing and answering questions relating to how infection in the reference period occurred, and whether steps which might have prevented these events were available and were taken timeously. Answering these questions is of paramount importance to those who acquired infection, and to those who lost loved ones.

1.22 In conclusion, there is one respect in which the Inquiry has identified action still required to deal with past transmission of HCV. In the look-back chapter (see Chapter 35), the Inquiry sets out its recommendation that people who received a blood transfusion in the period before screening of donated blood for HCV was introduced, on 1 September 1991, but who have never been tested for HCV, should now be offered such a test.

2. Patients at Risk >