THE PENROSE INQUIRY
Final Report

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Chapter 35

An Investigation into the Steps Taken to Identify the Individuals who were Infected (Look-back)

Introduction

35.1 Previous chapters have discussed the information available to doctors about HIV and Hepatitis C virus (HCV) infection as knowledge of the diseases and their treatment developed, the provision of relevant information to patients, and the introduction of HCV screening in September 1991. This chapter deals with the methods available to identify patients put at risk of HCV transmission by treatment with blood or blood products, and with the steps taken in that regard.

35.2 The methods of investigation available to regional directors included 'look-back'. Look-back seeks to connect information about patients, blood components or products thought to be transmitting infection and the donors who provided the blood. In practice, two types of look-back were developed, called in the UK 'targeted' and 'reverse' look-back.

35.3 In 'targeted look-back' the process begins when a blood donor is found to be infected when tested for a specific pathogen such as HIV or HCV. The donation history of the infected individual is then investigated with a view to tracing possible recipients of blood, blood components or products prepared from previous donations by that person to ascertain whether such recipients may have contracted the virus harboured by the donor. Any blood, blood components or products derived from an infected donor still in stock can be identified; blood banks and peripheral hospitals can be advised and material they hold quarantined.

35.4 In 'reverse look-back' (in North America often called 'trace-back') the process begins when a patient presents to a clinician with relevant signs and symptoms of a disease. In the case of HCV the clinician would often be a hepatologist and the signs and symptoms would be of liver disease. If investigations disclose HCV infection and there is a history of previous transfusion with blood, blood components or products, the clinician informs the relevant blood bank which then endeavours to trace the donor or donors who may have donated infected blood. Withdrawing blood, blood components or products is generally not possible as a result of reverse look-back, at least initially and often generally; the starting point is not the infective donor but the infected recipient and, quite often, the transfusion that transmitted infection will have taken place many years previously so that it would be almost certain that all of the blood, components or products derived from the implicated donation would have been used or gone out of date by the time of the investigation.^[1] In contrast to targeted look-back, reverse look-back is not dependent on the availability of a screening test for the virus or its antibodies.

35.5 This chapter is concerned primarily with look-back as it relates to HCV. However, the approach to HCV look-back was influenced by previous experience of exercises related to HIV and it is appropriate to comment on that experience in the first place.

Early experience with look-back in the United Kingdom

35.6 As discussed in Chapter 10, Knowledge of the Geographical Spread and Prevalence of HIV/AIDS 2, growing awareness of cases of AIDS among haemophilia patients, particularly those with Haemophilia A, in 1984-85 spurred attempts to estimate the prevalence of HIV infection in the UK. In Scotland, the infection of 'the Edinburgh Cohort' was discovered and disclosed at the end of 1984.^[2] It was initially thought that one specific batch of Scottish National Blood Transfusion Service (SNBTS) Factor VIII concentrate had probably caused the infection but, at the time, a definitive investigation would have to await a reliable test for infectivity. All but one of the 16 patients with Haemophilia A who had developed anti-HTLV-III had received the so-called 'implicated batch' between March and May 1984.^[3] At about the same time it was discovered that a number of west of Scotland patients had also been infected. Details were disclosed in May 1985.^[4] These discoveries presented the initial data for a reverse look-back exercise, which concentrated on following up data from the Edinburgh and south east Scotland region.

35.7 In this respect, the exercise was an illustration of the SNBTS' ability to undertake reverse look-back procedure for investigating the histories of recipients of blood or blood products who had been found to be infected. It was a means, in at least some cases, of ascertaining information on transmission of infection, however difficult and limited in the circumstances, independent of the targeted look-back studies discussed in this chapter.

35.8 The SNBTS recording system allowed the tracing of donations which had made up an 'implicated batch'. Regional Transfusion Centres (RTCs) kept records of donations sufficient to identify the specific donors who had contributed to a batch of blood products thought to have transmitted infection.^[5] It was then possible to follow up those donors who returned to later donation sessions and were screened.^[6] As noted below, and discussed more fully in Chapter 28, Donor Selection - AIDS, at the same time as the SNBTS was attempting to identify 'implicated donors' there was a well-publicised, and effective, campaign to discourage 'high-risk donors' from donating blood.

35.9 Subsequently, the SNBTS considered undertaking a look-back exercise aimed at tracing and testing the donors of all 4000 donations potentially associated with the transmission of HIV infection to the Edinburgh Cohort. These would have been all of the individuals who had donated blood which had contributed to the implicated batch, not just those who might have been captured as return donors. However, blood samples were available for only 50% of these donors and the view was taken that it would therefore be impossible to trace the course of donations by this method.^[7]

35.10 In one respect at least, the work done on HIV look-back was to have a lasting significance. In September 1984, Dr John Gillon was appointed as a Senior Registrar in the South East Scotland Blood Transfusion Service (SEBTS). He became a Consultant Physician in that service in April 1985. His responsibilities included the selection and medical care of donors.^[8] On 20 November 1984 he was asked to visit transfusion centres and discuss the care and selection of donors and to prepare a memorandum on the subject for consideration by the SNBTS Directors.^[9]

35.11 Around the time Dr Gillon took up his post, and following the introduction of an HIV test in late 1984, it was agreed across the UK that donor testing for HIV would be accompanied by targeted look-back, when donors tested positive on screening, from the outset. Dr Gillon assumed responsibility for this in his area, the south east Scotland region, and inherited files on the one or two historical look-back studies arising from instances where clinicians had identified an HIV-infected donor and carried out a targeted look-back.^[10]

35.12 By way of preparation, Dr Gillon and Dr Jan Davidson, one of the sessional medical doctors in his centre, had each spent one or two weeks at St Mary's Hospital in London with Dr Tony Pinching, who at that time had the largest cohort of HIV-positive patients in the country. Dr Pinching provided a counselling course on HIV testing at St Mary's, which Dr Davidson attended. Dr Gillon also visited the genito-urinary medicine (GUM) clinic and had discussions with microbiologists.^[11]

35.13 Dr Gillon and Dr Davidson shared the work of counselling blood donors found to be HIV-positive on screening. Dr Gillon took responsibility for counselling the patients who came to attention through the look-back exercise that followed identification of an HIV-positive blood donor, because the number of affected individuals was small. Dr Gillon explained that, through this work, he and Dr Davidson gained valuable experience of the sort of issues that would crop up when dealing with donors who either tested positive after donating blood or who were found to be infected through look-back.^[12]

35.14 Dr Gillon was later to play a significant role in the development of a local HCV look-back programme. He explained the procedure involved in reverse look-back in more detail, with reference to non-A, non-B Hepatitis (NANB Hepatitis).

35.15 On receiving a report of NANB Hepatitis infection in the recipient of blood, blood components or products, the SNBTS would seek details of the relevant transfusion episode(s), including all of the units that were transfused, and would then identify the donors associated with the implicated blood, blood components or products and carry out investigations to see if they could find the donor(s) who had transmitted infection. This could clearly be an onerous task as all of the relevant donors would have to be recalled: sometimes there could be hundreds of donors although more often it would be a smaller number.^[13]

35.16 Having identified the donors possibly implicated in transmitting infection, those individuals would be called in, told there had been a problem with a patient who had received their blood (usually along with other donations) and that there was a need to investigate the source of infection. Each donor would have a full medical history taken with a view to identifying any possible risk factors and also have a liver function test performed. Before effective screening for HCV was introduced in the UK in 1991, the end result was often inconclusive, with the result that often both the donors and the SNBTS, as Dr Gillon remarked, were left 'in limbo to some extent'.^[14]

Experience of HIV look-back in the United States

35.17 The history of HIV look-back studies in the USA was discussed in an article by MP Busch (University of California) in the journal Transfusion.^[15] The first initiative calling for notification of HIV infection had arisen from the case of the infection of the 'San Francisco child' (discussed in Chapter 11, HIV/AIDS Aetiology, paragraphs 11.24-11.25). The US Centers for Disease Control (CDC) sponsored and funded investigations of all reported AIDS cases in an attempt to identify infected donors and thereby trace, enrol and follow recipients of their blood. However, only a few US blood centres participated in the programme until 1985, when routine donor screening was introduced. The term 'look-back' was adopted at that point to describe the process of tracing transfusion recipients of donations triggered by screening. The procedure was expanded by some blood banks to include other methods of investigation and, according to Busch, became slow and possibly inherently inadequate. The CDC recommended that physicians should consider testing recipients of multiple units of blood or components ('general look-back').

35.18 When antibody screening for HTLV-III (later HIV) was introduced in the USA in 1985, targeted look-back was implemented without much discussion. Busch set out to test the effectiveness of the HIV look-back programmes with specific reference to the San Francisco Bay area. He reported that it was found that the implementation of early high-risk donor education coincided with a dramatic reduction in the frequency of infected donations and, consequently, in the risk to recipients. It was estimated that approximately 90% of infected, high-risk donors self-deferred or were deferred prior to the availability of specific anti-HIV screening. A second study reported that standard targeted look-back was only minimally effective. The conclusion was that:

[T]hese studies show that the overall yield and efficacy of HIV look-back programs were poor. Standard, targeted look-back was limited, ironically, by the effectiveness of early self-exclusion measures, in that almost all of those responsible for HIV infections had stopped donating before they could be identified by anti-HIV screening.^[16]

Additional limitations included the high death rate of recipients of infected blood together with the delay in, and logistics of, manual record searching and individual recipient tracing and notification through hospitals and private physicians.^[17]

35.19 Busch predicted that standard targeted HCV look-back would be enormously cumbersome and expensive and would also be ineffective for the same reason as the HIV look-back programme: the vast majority of infected former donors would already have been deferred or excluded from donation by the 'surrogate' measures in force long before the anti-HCV test became available. Those individuals would be 'invisible' to targeted look-back. Busch noted that the US Public Health Service had recently decided not to recommend anti-HCV testing of previous transfusion recipients. The reasons given were that, first, HCV was endemic in the general population, unlike HIV which was an epidemically spreading fatal infection clustered in specific regions, with transfusion of blood, blood components or blood products a major route of transmission. Secondly, sexual transmission of HIV was well documented; in contrast modes of community spread of HCV were much less well understood. Thirdly, therapy for HCV infection was of limited effectiveness. Fourthly, the relative risk of HCV transmission in transfusion recipients was much lower in relation to the background risk of the illness than had been the case with HIV. Lastly, there were public health financial considerations that were peculiar to the USA.

35.20 Busch stated:

So what do we do?

....

I am convinced that the appropriate response to this situation is an aggressive education campaign for both physicians and the lay public about the risks and benefits, both in the past and the present, of transfusions.^[18]

35.21 He advocated a well orchestrated, long-term education campaign, targeting past and future transfusion recipients and donors, and felt that the long-term gains from committing necessarily limited resources to this would 'far outweigh' the 'minimal short-term yield of any specific HCV look-back effort'.^[19]

35.22 Busch's paper was published in 1991. An anti-HCV test, first available in 1989, was introduced into routine screening in the UK in September 1991.^[20] As the article indicates, in the USA 'trace-back' followed on from well-documented cases of post-transfusion NANB Hepatitis before the isolation of HCV allowed for specific testing, using 'surrogate testing' methods. Surrogate testing by the methods adopted in the USA was not adopted in the UK, as discussed in Chapter 27, Surrogate Testing of Donated Blood for non-A, non-B Hepatitis. The SNBTS Directors recommended in March 1987 that surrogate testing should be introduced in 1988 (or at least considered that its introduction was inevitable).^[21] Others in the transfusion services in Scotland and England did not support the introduction of such testing. Nor did the government health departments in Scotland or England. Irrespective of the merits of the arguments about surrogate testing, it appears to be important to note that Busch's argument against 'trace-back' relied heavily on a factor that did not apply in this country.

The institutional arrangements

35.23 Difficulties with the administrative control of, and responsibility for, policy in Scotland in relation to transfusion generally have been discussed in Chapter 17, Blood and Blood Products Management. The events discussed in this chapter provide an illustration of some of the practical problems that arose from the lack of well defined boundaries between bodies with an interest in providing advice on, and in the implementation of, look-back. It is appropriate in the first instance to note the formal position.

35.24 There were two national (UK) advisory committees with an interest in the topic of look-back during the material time. The Advisory Committee for Virological Safety of Blood, later renamed the Advisory Committee on Microbiological Safety of Blood or Microbiological Safety of Blood and Tissue, advised Ministers of all four territorial departments of the UK. To avoid confusion, this committee will be referred to in this chapter as the ACVSB/MSBT. The Advisory Committee on Transfusion Transmitted Diseases, otherwise known as the Advisory Committee on Transfusion Transmitted Infections, gave advice to the ACVSB/MSBT on transfusion-transmitted infections but did not advise Ministers directly. This committee will be referred to as the ACTTD/I.

35.25 Nominally, statutory responsibility for the provision of blood and blood products in Scotland was devolved to the Common Services Agency (CSA). Evidence before the Inquiry, however, would suggest that for most practical purposes the SNBTS operated independently of the CSA in technical and scientific matters, in direct contact with the Scottish Home and Health Department (SHHD). An additional advisory committee, the Medical and Scientific Committee (MSC) of the SNBTS, was established in August 1990 and had its first meeting for regular business on 6 November 1990.^[22] The MSC advised the SNBTS Board and became closely involved in the topic of look-back.

35.26 Mr David McIntosh was Chairman and General Manager of the SNBTS from 1990 until 1996 and was responsible for the overall performance of the service at the time anti-HCV screening was introduced and the issue of look-back was under active consideration. In 1996, by mutual agreement between himself and his employers, his contract was not renewed.

35.27 He said that, when he joined the SNBTS in 1990, it was run by the Regional Directors. They were members of a national organisation but mainly ran their own transfusion services in the major cities in Scotland independently of centrally imposed policies. All of the Directors were medically or scientifically qualified. The commonly accepted assertion of professional clinical independence meant that, within their regions, Directors could run things and make their own decisions almost as they wished, provided it conformed to the overall ethos of the SNBTS.^[23] He found that 'none of the normal management common sense you can take for granted in most organisations outwith the public sector applied'.^[24] Mr McIntosh described the difficulties he faced in attempting to introduce modern management practice to the SNBTS and, in particular, the resistance he encountered from the medically and scientifically qualified Directors with whom he had to deal.^[25]

35.28 He was asked about his role in establishing, and subsequent involvement with, the MSC. After three months with the SNBTS he recommended they set up a Medical and Scientific Committee as an advisory scientific sub-committee of the SNBTS Board in order to make a clear distinction between the medical and scientific side of the SNBTS and the managerial wing that he, as general manager, was responsible for.^[26] His role in relation to the committee, he felt, was to help professional colleagues to come to clear conclusions on appropriate recommendations, intervening in detailed debate if asked to do so and ensuring that an appropriate, practical plan of action was prepared, authorised and implemented when decisions were reached. He assisted the members in achieving their goals by, as he put it, 'cajoling and persuading and coaching', but attended MSC meetings only occasionally.^[27] Mr McIntosh commented that the role of the committee 'should have been to produce lucid recommendations'.^[28] He went on to point out that a public health exercise like look-back was not just about the SNBTS testing blood: it would involve the cooperation of haemophilia directors, hepatologists, GPs and hospital administrators.^[29]

35.29 The impression Mr McIntosh gave of his early experience was of frustrated impotence in the face of an organisation that had been in existence for 50 years, staffed by highly qualified professionals (20% of whom had PhD degrees) without ever having any expert management.^[30] He felt that the MSC came to be 'the government in exile of the SNBTS', with precedence over 'silly little administrative people called "managers"'.^[31] Professor Cash did not consider that Mr McIntosh's assessment of the managerial competence of the SNBTS was accurate, observing that many of the tools of modern management were already in place throughout the SNBTS when Mr McIntosh took over. He pointed out that prior to the arrival of the General Manager the service had developed successful Research and Development programmes which were internationally recognised. The size and complexity of these Service and Research Developments were of such a magnitude that their success was inevitably dependant on at least some aspects of sound modern management practice.

35.30 Dr Mitchell and Professor Urbaniak also did not accept Mr McIntosh's suggestion that prior to his arrival there had been an absence of expert management. Professor Urbaniak noted that in about 1986 the General Manager of the CSA introduced a number of seminars and courses on management principles for all the senior officers of the CSA. The SNBTS Directors, whose responsibilities within their respective regions included budgeting and staff, attended those events. Professor Cash did not accept that Mr McIntosh had been met with collective resistance to managerial change. Dr McClelland considered that the history and managerial structure of the organisation might have resulted in certain tensions arising at a higher management level. Neither Dr Brookes nor Professor Urbaniak accepted Mr McIntosh's description of his relationship with the Regional Directors, the latter suggesting that assistance given to Mr McIntosh by the Directors due to his unfamiliarity with the public sector might have been misinterpreted by him as resistance.

35.31 Dr Perry, whilst aware of Mr McIntosh's concerns and frustrations in connection with perceived resistance from SNBTS Directors, considered that he and the General Manager had enjoyed a productive and mutually supportive relationship which resulted in many positive developments and outcomes. Whether Mr McIntosh's assessment of the position was correct or fair is, perhaps, of less significance than the fact that he clearly believed that his management was resented and that he had little managerial authority over the affairs of the SNBTS. What is clear is that regional autonomy gave Directors the scope to adopt their own policies and that became important in the context of HCV screening generally and HCV look-back in particular.

Donor screening for HCV

Early screening in Scotland

35.32 On 21 June 1990, Professor Cash wrote to Dr Gillon in anticipation of the commencement of full anti-HCV donation screening, inviting him to chair a working party to draft operational guidelines, for consideration by the SNBTS Directors, on counselling^[32] donors confirmed to be anti-HCV positive.^[33] As there was a wish to see as much harmonisation north and south of the border as possible, he asked Dr Gillon to keep Dr Harold Gunson, adviser on blood transfusion to the DHSS, informed.

35.33 As a result of the HIV exercise, the south east region of the SNBTS (the SEBTS) and other regions held extensive archives of samples of blood donations. The first archive of blood samples started in the SEBTS in the middle of 1984 and Dr Gillon said that by early 1986 all of the Scottish centres were laying down a sample of every donation. That has continued to this day and all of those samples, very many millions, are still retained, apart from those that have been used up in retrospective testing.^[34]

35.34 Dr Gillon's previous experience indicated that, though the numbers of donors found positive for HIV were not huge, there were some regular donors among them. The working group was aware of the experience of researchers in San Francisco, reported by Dr Busch, and knew that look-back was not an easy process.^[35] They also knew from their own experience with HIV that HCV look-back would be difficult.^[36] Dr Gillon said that, with a new HCV test, it was likely that within the first six months of testing a large proportion of regular donors would be processed and that there would be a 'hump' in the curve of infections found following the introduction of a new test. Dr Gillon's working party came to a unanimous decision that there should be a look-back following identification of donors found to be HCV-positive. This was recommended in its report which went to the Directors of the SNBTS for discussion.^[37]

35.35 The availability in 1990 of first-generation HCV tests in Scotland for validation studies, gave some indication of the number of individuals likely to be involved. Dr Eddie Follett and Dr Brian Dow (West of Scotland Blood Transfusion Service) had first-generation kits to examine and had looked at some archived samples and, Dr Gillon thought, probably some fresh donor samples as well. The numbers were daunting and gave rise to the anticipation of considerable logistical and resource issues. Dr Gillon explained that initially it looked as though 0.5-0.6% of Scottish donors would test positive for antibodies to HCV. Based on assumptions about the daily rate of donations given on weekdays, this indicated that about 10 samples a day in Scotland would test positive for HCV and it was clear that a look-back exercise based on those numbers would require extra resources. He explained that the likely requirement for extra resources was one of the reasons why he felt that the working party made an early recommendation to commence look-back by saying 'in principle we think this needs to be done'.^[38]

35.36 The recommendation was inconsistent with discussions that had been progressing at national (UK) level and it is appropriate to note these before returning in more detail to the output from Dr Gillon's working group.

Discussions at the United Kingdom level

35.37 On 1 May 1990, Professor Cash wrote a letter to Dr Gunson headed 'HCV: Look Back'.^[39] In the letter, Professor Cash suggested that, in advance of anticipated universal HCV testing of donations, the tests then available should be used in cases of post-transfusion NANB Hepatitis 'so that we can more readily locate "the offending donor" with a view to taking him/her off the panel'. From its terms, the letter, and Dr Gunson's reply (referred to below), related to reverse look-back as defined by Dr Gillon. Dr Gillon thought that this correspondence between Professor Cash and Dr Gunson related to reverse look-back. Professor Cash confirmed in evidence that he was not referring to targeted look-back at this stage.^[40]

35.38 As reflected in his evidence, Professor Cash's recollection of the background to the correspondence was poor. He said that he could not remember what specific discussions he had held with Dr Gunson at about this time. In general terms, however, he said that Dr Gunson was 'pretty unenthusiastic for a very long period of time, at the whole notion of look-back because ... for England and Wales, the nature of their structure of their transfusion services made it ... a giant of a task'.^[41] In what appears to have been his reply to Professor Cash, Dr Gunson wrote on 21 May 1990 commenting that he was unsure whether RTCs in England and Wales would have access to anti-HCV test material and suggesting that it might be worthwhile carrying out 'the usual investigations' when a transfusion-associated NANB Hepatitis case was reported and to ensure that a library sample of serum was retained from each donor seen.^[42] At that time, the 'usual investigations' referred to reverse look-back. The letter referred to an intended meeting on 27 June but in his oral testimony Professor Cash could not recall if the topic of look-back was, in fact, discussed when they met.^[43] The Inquiry was left with Professor Cash's general impressions of the developing position.

35.39 Professor Cash said that his initial response to Dr Gunson's position was to accept his reservations, at least for a while, describing his attitude as: 'Okay, we will buy it so far, Harold'. Subsequently, however, he said that he 'took this matter further'. Professor Cash was asked why he thought it was an important factor in making a decision about look-back that he had to discuss the topic with Dr Gunson and then report to the SNBTS. It was suggested to him that it should, perhaps, have been the other way round, that he should have first discussed the matter with the SNBTS Directors and then held discussions with Dr Gunson. In response, Professor Cash said that, as could be seen from contemporaneous correspondence, he did, in fact, discuss it with the SNBTS Directors and had said to them that he would start liaising with his counterparts in England and Wales: 'So it had been discussed, as I understand it, before July 1990'.^[44]

35.40 Professor Cash was, however, unable to recall in detail the relevant facts and circumstances that would have clarified his position on look-back at this period. He acknowledged that at this point the SNBTS did not have a general policy, saying: 'we were fishing around to explore are we really going to push this or not ...'. As noted, the SNBTS had instituted a look-back procedure for HIV and Professor Cash considered that the SNBTS ought to have at least been thinking about something similar in relation to HCV.^[45]

35.41 Dr Gillon provided some background information on what was happening in Scotland at the time.^[46] As noted above, in 1990 some limited reverse look-back was being done by SNBTS doctors. However, it was on an informal and less than systematic basis. SNBTS doctors knew that Dr Follett could test 'implicated' donor samples and they would ask him to do that and follow up the results. Dr Gillon said that 'it would have been crazy not to'.^[47] However, targeted look-back could only begin once routine donor screening was introduced across the donor population. The impression given by Dr Gillon's evidence was that practice on the ground was more varied, and in some respects and in some regions more developed, than was implicit in the correspondence between the medical directors.^[48]

35.42 Professor Cash's letter of 1 May 1990 to Dr Gunson was copied to the Scottish Directors, including Dr Ruthven Mitchell who was a member of the ACVSB/MSBT. In a letter dated 14 May, Dr Mitchell defined the problem from a UK perspective: whether or not the UK blood transfusion services generally (the SNBTS and the NBTS) should have a policy of identifying donors who may have transmitted disease when there had been a report of NANB Hepatitis transmission.^[49] He noted that he had raised the issue at a recent meeting of the ACVSB/MSBT, and reported:

I have advised Bob Crawford at the present time that we have no look-back policy, although you will understand that in doing so, the Service could be considered to be negligent in not advising about potential future use of donor blood.

At this stage, therefore, look-back was not supported by blood transfusion service policy.

35.43 Professor Cash suggested that Dr Mitchell was also signalling in this letter that, if the SNBTS did think about a look-back programme that would include the west of Scotland (where Dr Mitchell was Director), it was going be 'a big, difficult problem'.^[50]

35.44 The UK policy position appears to have become further refined by early July. On 9 July 1990 Professor Cash wrote to Drs Whitrow, Urbaniak, Brookes, McClelland, Mitchell and Perry, copying the letter to Dr Gunson and Mr McIntosh.^[51] He stated:

[I] have discussed this topic with Harold Gunson.

We both agreed the following:

(a) It would not, after we start anti-HCV donation screening, be appropriate to introduce a systematic look-back programme on previous recipients - as was done for HIV-1.

(b) It would be appropriate, in the period before routine anti-HCV donation screening commences, to examine the anti-HCV status of donors who have been implicated in a case of reported PTH [post-transfusion hepatitis].^[52]

35.45 Professor Cash's letter to Dr Gillon dated 21 June 1990 inviting him to chair the drafting of operational guidelines was therefore written against a background of continuing debate about look-back exercises generally. By the time Dr Gillon submitted his working group's proposals, a preliminary decision had been reached at the UK level not to begin a programme of targeted look-back when donor testing for HCV commenced.

Draft guidelines

First draft

35.46 Against the background of these exchanges between the medical directors, Dr Gillon's group proceeded to prepare a draft guidelines document on donor counselling as requested in Professor Cash's letter of 21 June.^[53] A copy of a draft was sent to Professor Cash on 20 September 1990.^[54] The document took the form of a report to Professor Cash as National Medical Director of the SNBTS.^[55] As indicated in the letter, an earlier draft of the guidelines had been sent to Dr Gunson for comment but by 20 September comments had not been received. Dr Gillon anticipated that the MSC would debate the guidelines.

35.47 The draft guidelines reflected the group's view that it was important for careful consideration to be given to the provision of information to all blood donors. The draft contained detailed proposals for counselling donors found positive for anti-HCV on screening. The working group had received information that there had been practical difficulties in donor counselling in the north region and commented:

The Group therefore agreed that the extent of counselling and investigation undertaken must be at the discretion of any RTD, depending on local circumstances. It is our view that our duty is to inform the donor personally, ie at an interview with a member of SNBTS medical staff or another doctor recruited for that purpose.^[56]

35.48 Follow-up investigations would involve the donor's GP or a local specialist. The report also formally introduced the notion of HCV look-back:

The Group discussed the question of lookback. Donors may well ask about the outcome of their previous donations, and a clear policy on lookback is essential. We note the logistical difficulties, which have been taken as justification by the AABB [American Association of Blood Banks] for not recommending a lookback, but our view was that this position is untenable in view of the desirability of informing recipients so that they can protect others, and also receive treatment with Interferon if the benefits of this form of therapy are confirmed.^[57]

35.49 The final part of the report contained advice on 'informing the donor'.^[58] Dr Gillon said that it was an attempt to be very practical. The working group was trying to describe in very clear terms what needed to be done to make the look-back work so that doctors who did not have much experience of look-back would be able to do it with little additional training. It was not envisaged that this section would be given to the patient. Rather, it would be used by the doctor to impart information and was framed as a set of potential questions and suggested answers.^[59]

35.50 One of the questions a donor found to be infected might ask of a consultant, Dr Gillon noted, was 'what about my previous donations?'. The guidelines provided possible answers to this question together with general advice:

The recipients of previous donations will be traced and their Consultants or GPs informed. We hope to obtain results of any tests carried out. However, it may cause distress to the donor to discuss this matter in any detail. A general comment suggesting that we are going to check to see that the recipients are alright, that they get any treatment they may require, should be sufficient.^[60]

35.51 Dr Gillon said that this was a reference to targeted look-back.^[61] As indicated above, this proposal was at variance with the policy position agreed between Professor Cash and Dr Gunson.

First draft: reception and reaction

35.52 Professor Cash said that he realised when he read the draft guidelines that Dr Gillon was advocating a look-back policy. He did not accept that it was an expression of SNBTS policy. Rather, it was a proposal from Dr Gillon's working group which was delivering the view that the SNBTS needed to do a look-back. He considered that it was an issue that the SNBTS needed to think about carefully.^[62]

35.53 Professor Cash circulated the report prepared by Dr Gillon's group to Dr Perry and the Regional Directors, Dr Brookes, Dr McClelland, Dr Mitchell, Dr Urbaniak and Dr Whitrow, on 4 October 1990 with a copy to Mr McIntosh for information.^[63] The letter asked the Directors to review the report before the MSC meeting on 6 November 1990.

35.54 Dr Gillon was not a member of the MSC, but attended part of the meeting on 6 November to present his guidelines document. As the minutes of the meeting make clear, the report was discussed before he joined the meeting.^[64] Dr Mitchell is reported to have advised that 'Dr Gunson was anxious to take this Gillon document to the National Advisory Committee in the near future'.^[65] Dr Gillon then joined the meeting and gave a brief summary of the report, following which there was lengthy discussion. Dr Gillon did not have a clear memory of the discussion about the guidelines. He drew attention to paragraph 10 of the minute, headed 'HCV Look-Back', which recorded that:

After discussion it was agreed that Professor Cash should write to the Chairman of the DoH Advisory Committee on the Virus Safety of Blood, asking that careful consideration be given to the matter of HCV look back of recipients of previous donations.^[66]

35.55 Dr Gillon said that decision was a reference to targeted look-back. His recollection was that the MSC at this stage had a generally positive attitude to targeted look-back. However, he thought that there were some people who had reservations, particularly in the west of Scotland, where, as Professor Cash had noted, the size of the region and number of people involved could pose logistical problems. He recalled that even Dr Crawford, who was a member of the working party which had put forward the recommendations, was 'very leery' of look-back because of the amount of work it would create. Dr Gillon felt that the answer to that was to provide more resources: he and his colleagues would need secretarial help. He did not consider that they were talking about a vast amount of money but they knew that they would need extra funds to carry out the work.^[67]

35.56 It was agreed by the Committee that Dr Gillon should re-draft the document:

(i) In a format which was that of professional/operational guidelines.

(ii) That counselling information which all HCV confirmed positive donors would be advised was clearly delineated.

(iii) That thereafter a series of supplementary questions/answers were made available.

(iv) That consideration be given to including information on the treatment of HCV hepatitis and the issue of safe sex.^[68]

35.57 Dr Gillon agreed to prepare a draft Standard Operating Procedure based on the report by 30 November 1990 for submission to the members of the MSC for their consideration.^[69]

35.58 Dr Gillon recalled that Professor Cash wrote to him and said that the guidelines were 'very well received' and that the Scottish Directors had accepted them and that he would be sharing them with colleagues in England and discussing it with them.^[70]

35.59 In his oral evidence, Professor Cash was initially unable to recall what his own attitude was to look-back at that point although he thought that he was 'enthusiastic', though not without reservation.^[71] He went on to say that he was a 'strong supporter of look-back' but that his reservations related to the absence of treatment for HCV at the time: 'I was very warmly in favour [of the idea of look-back], but I wasn't prepared to push it until I had some good evidence ... that there was a treatment option'. He thought this was 'a very interesting philosophical issue' and that his attitude probably reflected attitudes common at the time: 'I had been brought up in a different era, in which doctors should do their best, as part of their caring, to filter in some way stuff that really they didn't feel the patient needed to know'.^[72] As discussed in Chapter 32, An Investigation into the Systems in Place for Informing Patients about the Risks - Ethical Context, the approach of the medical profession to patients up to at least the mid-1980s was generally 'paternalistic' in nature, and only progressively less so in the early 1990s. As presented in evidence, Professor Cash's reservations may reflect that stance when he said: 'if you haven't got some good news for the patient, i.e., "We have got some treatment here that can be of serious benefit to you," ... loading a lot of innocent people with bad news, unnecessarily, is not a good thing to do'.^[73] However, as Dr Gillon pointed out, the lack of treatment for HIV was not considered sufficient reason for not introducing targeted HIV look-back in the mid-80s.^[74]

Perceptions at the United Kingdom level

35.60 Following the MSC meeting of 6 November 1990, Professor Cash wrote to Dr Jeremy Metters, Deputy Chief Medical Officer at the Department of Health (DoH) and Chairman of the ACVSB/MSBT. The letter, headed 'HCV: Donation Testing: Look back',^[75] said that the SNBTS Directors had asked Professor Cash to write requesting that the ACVSB/MSBT consider a policy of look-back in anticipation of the commencement of testing blood donations for HCV throughout the UK. In oral evidence, Professor Cash said that he had come to the conclusion that look-back was something about which the SNBTS ought to 'touch base' with the advisory committee, although he was not sure whether he had come to this conclusion because of discussions with Dr Gunson or SNBTS colleagues. He explained that it was important to him that Dr Archibald McIntyre, SHHD, Dr Mitchell and Dr Perry received a copy of the letter because they sat on the ACVSB/MSBT. They had been briefed and knew that the Scottish Directors were very keen that look-back should be discussed.^[76] In its terms, the letter appears to follow the decision of the MSC of 6 November, though with less specification of the interest of the members of the committee.

35.61 Professor Cash explained that the reason he wanted the ACVSB/MSBT to consider the question of look-back was because he was of the view that initiating look-back would require the Chief Medical Officer (CMO) to instruct the Regional Health Authorities in England and Wales and the Health Boards in Scotland and because it would require the active collaboration of clinicians and peripheral laboratories. He stated that 'the only route we had at that time, that I am aware of, to get into ministerial approval was the Metters committee'.^[77]

35.62 At this stage, it is important to note that the precise sequence of events is less than clear. The ACTTD/I met on 8 January 1991.^[78] There was extensive discussion of the procedures to be put in place for anti-HCV screening. Dr Gillon's paper was discussed, as was a paper by Dr Contreras. Dr Gillon agreed that he would amend his paper in the light of written comments he was to receive from Dr Contreras and others. It was noted that arrangements should be made for counselling donors reported to be positive by recombinant immunoblot assay (RIBA) and subsequently confirmed as positive by a polymerase chain reaction (PCR) test. In further discussion, it was agreed that:

[T]here may be an ethical obligation to inform patients who may have received transfusions in the past from anti-HCV positive donations. This will involve considerable additional work including testing of library samples and will have to be funded. Extension of this to epidemiological investigations should be the subject of separate research studies.^[79]

35.63 After its meeting on 6 November 1990, the MSC next met on 19 February 1991. In relation to donor counselling, the minutes of the meeting state:

The Committee examined Dr Gillon's final draft document, which had been previously circulated and agreed it was excellent. The Committee proposed and agreed that the latter pages be used as Guidelines in leaflet form for use by the RTCs.

In the light of national events, it was agreed no "Look Back" should be introduced at present.^[80]

From the terms of the minutes it appears that intelligence was available that there had been a decision at the UK level that HCV look-back should not be implemented. The ACVSB/MSBT had last met on 21 November 1990. It would next meet on 25 February 1991.^[81] It could not have been involved, as a committee, in articulating objections to screening on grounds of 'national events'. The Inquiry has not uncovered any record of 'national events' leading to an agreement that look-back should not be introduced at that stage.

35.64 Professor Cash was unable to recall what the 'national events' referred to were. He said it was possible that 'signals' had been made through Dr Gunson to him indicating that the ACVSB/MSBT was minded to reject look-back at their next meeting, as discussed below, and that he had reported this to his colleagues.^[82] He later suggested that he may have spoken with Dr Gunson directly in advance of the MSC meeting and become aware that 'look-back was not a runner at the moment'.^[83]

35.65 Professor Cash also said that he could not recall whether there had been much discussion about the advisability of proceeding with look-back at the MSC meeting, beyond what is recorded in the minutes. He did not accept that he would have gone to the meeting and simply explained that, because it appeared that look-back was not going to proceed in England and Wales, he did not think it would be possible to do look-back in Scotland. He thought it more likely that he thought that it would be necessary to 'get more ammunition' to press the case for action in Scotland.^[84]

35.66 The ACVSB/MSBT held its ninth meeting on 25 February 1991.^[85] The events leading up to that meeting are discussed in detail in Chapter 31, The Introduction of Screening of Donated Blood for Hepatitis C. On 21 November 1990 the ACVSB/MSBT had sufficient information about the test kits then available, manufactured by Ortho and Abbott, to conclude, on Dr Gunson's advice, that the kits could be 'deemed' to be satisfactory for routine use.^[86] The committee concluded that a combination of RIBA and PCR tests would provide a confirmatory service and agreed that it was important to start screening as soon as possible.^[87] A full submission was sent by the DoH to Ministers on 21 December 1990.^[88] Discussion of the delay that then occurred in processing Ministerial consideration of the issue need not be repeated here. What is relevant is that, as time passed, the emphasis shifted to the need for 'proper' evaluation of the second-generation Abbott and Ortho kits that were expected to become available in July 1991.^[89] Abbott had launched their second-generation test on 8 April 1991.^[90] More widely, financing the introduction of screening had increasingly become recognised as a problem for health authorities in England and Wales. The start date for screening of 1 September 1991 was adopted against that background.

35.67 On 25 February 1991 the ACVSB/MSBT understood that licensing of the second-generation kits by the US Food and Drug Administration (FDA) had not been completed, that issues over patent rights had not been resolved and that further tests might identify new markers of infection.^[91] There was an air of uncertainty about the screening kits that might be selected. All 10,000 of the archived samples already tested were to be re-tested by second-generation kits.^[92] Funds for continued testing were to be sought by RTCs through normal channels.

35.68 At the meeting, Dr Mitchell reported orally on the discussions at the recent meeting of the ACTTD/I, and in particular on the procedures for anti-HCV testing.^[93] In relation to look-back, paragraph 14 of the minutes of the ACVSB/MSBT meeting states:

The Committee discussed the problems of look-back and recommended that it should not be undertaken as a service, leaving the option for those carrying out research. However, all cases of post-transfusion hepatitis should continue to be investigated.^[94]

The reasons for this recommendation were not minuted. The second sentence appears to support reverse look-back, leaving it unclear whether the first sentence relates to all forms of look-back.

35.69 Professor Cash explained that the phrase 'not undertaken as a service' meant that look-back would not be a routine part of the Blood Transfusion Service delivery. Asked if this applied to all blood transfusion services throughout the UK, Professor Cash replied that it was his understanding that the Ministers who were being advised by this committee included Scottish Ministers, although that did not necessarily prevent Scotland 'doing their own thing'.^[95]

The position of the Scottish Home and Health Department

35.70 There was no direct evidence available to the Inquiry of the position adopted by the SHHD at this stage. Dr Aileen Keel, Acting Chief Medical Officer for Scotland at the time of this Report, was appointed a Senior Medical Officer in the SHHD in March 1992 and was, therefore, not in office at the material time in 1990 and 1991 when targeted look-back was first discussed. She commented on the documentary evidence available from the earlier period and from her personal experience from 1992 onwards.

35.71 Dr Keel was referred to the minutes of the meeting of the ACVSB/MSBT held on 25 February 1991.^[96] Dr McIntyre, who was the Principal Medical Officer with responsibility for laboratories and blood transfusion when Dr Keel joined the department, was an observer at that meeting. When Dr Keel was appointed she took over responsibility for those areas and she thought that Dr McIntyre would probably have briefed her about previous meetings.^[97] As noted above, the minutes of this meeting of the ACVSB/MSBT recorded the decision not to proceed with look-back.^[98]

35.72 Dr Keel agreed that the effect of the decision was that the advice to Ministers was that look-back should not be pursued. She was referred to an SHHD minute from Dr McIntyre to Mr Panton dated 10 July 1991.^[99] Mr Panton was one of her policy colleagues who reported to Mr George Tucker, Assistant Principal, and was a key policy colleague in relation to look-back. The minute referred to a copy of recommendations for counselling HCV-positive donors, presumably Dr Gillon's working group document. Dr McIntyre was concerned with the comment in the minute that look-back would be initiated 'in accordance with SNBTS policy'. He queried whether look-back would be a good idea, because at that stage it was not clear whether those testing positive would have been infectious. He also commented: 'In certain circumstances it could also give rise to litigation and it may be that you would wish to discuss this particular point with our Solicitors before this policy is put into effect'. Although Dr Keel acknowledged that, from this memo, it appeared that Dr McIntyre was concerned that look-back might give rise to litigation, she could not remember this being an issue that was particularly stressed in discussions about HCV look-back at that time. The main memory that she had was that look-back 'wasn't considered feasible, that logistically it would be too difficult to undertake, rather than any major concerns around litigation'.^[100]

35.73 Professor Cash said he had no memory of concern within the Scottish Office at the time that look-back could give rise to litigation and did not consider that this was a factor that was taken into account when deciding about implementing look-back at this time.^[101]

35.74 So far as the evidence available to the Inquiry discloses, the SHHD position around mid-1991 was that targeted look-back had been advised against by the ACVSB/MSBT. There was no evidence that it was a 'live issue' for administrators in advising Ministers.

Reaction in the south east Scotland region to the Medical and Scientific Committee's decision of 19 February 1991

35.75 Professor Cash wrote to Dr Gillon on 12 March 1991 informing him that the MSC had agreed to the proposal that the latter pages of the draft guidance (those containing guidance on practice at RTCs) should be used nationally as guidelines in leaflet form within the RTCs.^[102] However, he commented that 'in the light of national events' (a phrase repeated from the MSC meeting minutes of 19 February), the section answering the question, 'What about my previous donations' and implying that look-back would be implemented, 'should be omitted from the final document'. Professor Cash agreed that that comment was made because of the stated attitude of the ACVSB/MSBT.^[103]

35.76 Dr Gillon said that, at the time, he had no idea what the phrase 'in light of national events' meant. He thought that he must have understood that there was disagreement in England about doing look-back. He did not recall ever being given an explanation by Professor Cash as to why the section relating to look-back had been omitted from the final draft. He thought that he would have understood it to be largely a resource issue but he knew that there were also some people in London who disagreed with look-back for ethical reasons: some clinicians had doubts about going ahead with look-back when affected patients could not be offered anything in the way of specific treatment. Despite an emerging body of evidence at this time about possible treatment with Interferon, his own 1990 guidelines having referred to it, Dr Gillon recalled that, if there was an ethical objection to look-back, it was 'usually couched in terms of no treatment being available'.^[104]

35.77 Dr Gillon noted that by March 1991 second-generation tests were becoming available which were both more specific (that is, had a low false positive rate) and more sensitive (that is, had a low false negative rate) and would pick up more true instances of HCV infection. Initial evaluation exercises suggested that the number of people affected might reduce tenfold. He also noted that, around the turn of the year 1990-91, a confirmatory test for HCV (a PCR test) was in the later stages of development and that it was available for use by September 1991, when routine screening for HCV in blood donation began. Thanks to the innovative work of Professor Peter Simmonds, Scotland was one of the very few countries, and possibly the only country, that had PCR testing as part of their confirmatory process right from the start.^[105]

35.78 Dr Gillon said that when he received the letter from Professor Cash in March 1991 he was 'pretty appalled'.^[106] He believed that the MSC had agreed, at least in principle, to implement look-back. He was confident that, from an ethical point of view, it was right to proceed with look-back and he felt strongly that the health service should be doing look-back from the point when donor screening for HCV commenced, as had been the case when HIV screening was introduced. He felt that, even if there was difficulty in coping with the number of people involved or the reliability of test kits, the attempt should at least be made. If more resources were required, these should have been sought. He said that he was willing to debate the question with anybody. He did not have an opportunity to debate it with Professor Cash other than being at meetings such as the MSC where it had seemed to him to have been accepted that look-back should be implemented. He explained that it came as a bit of a surprise that Scotland was not going to be doing look-back.^[107]

Screening technology: England and Wales and Scotland compared

35.79 Dr Graeme Alexander was asked by the Inquiry to comment on the introduction of the test for HCV antibodies in England and Wales and, later, the eventual introduction of the UK-wide HCV look-back programme in 1995. Dr Alexander was involved in the UK-wide look-back exercise as Chairman of the Hepatitis C Virus Steering Group, a body set up to ensure that the look-back strategy was managed 'efficiently and effectively and in line with ethical standards'. A database was developed over time for research purposes, for those involved directly with the steering group and other people in the UK with an interest in this area of research.^[108] It is important to bear in mind that, although he became closely involved in the implementation of look-back in the UK as a whole, Dr Alexander's evidence of the background to the exercise reflected the experience of an English practitioner and was, in some respects, in marked contrast to Dr Gillon's evidence.

35.80 Dr Alexander said that, when screening for HCV was introduced in England in September 1991, it was performed with a 'first generation' enzyme-linked immunosorbent assay (ELISA) kit. This assay proved to be both insensitive and non-specific (that is, gave rise to a large number of both false negative and false positive results) and a great deal of skill was required to ensure that the tests were interpreted appropriately. In particular, the false positive rate was between 50% and 70% when a low-risk population, such as blood donors, was screened.^[109] So far, experience was similar to that described by Dr Gillon above; in Scotland also, the first-generation kits produced a very high rate of false positive results.

35.81 Dr Alexander continued:

Within 18 months or so these tests were replaced by second generation ELISAs. At this point ... it was agreed generally that a second RIBA test ... should be performed before telling patients that they were positive for HCV.^[110]

35.82 The RIBA was often described as a 'confirmatory test' but Dr Alexander noted in oral evidence that the RIBA was really the same test as the ELISA, using the same proteins but performed using a different method. Nevertheless, it made practitioners more confident they had the correct test result for their patients.^[111]

35.83 Despite their obvious deficiencies, Dr Alexander thought that the early anti-HCV tests were a major breakthrough for clinicians in the management of HCV infection. Even the early kits with poor specificity and sensitivity were of considerable use in monitoring higher-risk groups (such as haemophilia patients, transplant patients and post-transfusion patients). In his evidence, he observed: 'if a patient was likely to be at risk of catching Hepatitis C, then the test was probably more valuable than in a patient who was picked randomly from the street who wasn't at risk'.^[112] In his statement he noted: 'The correct approach to using the first generation tests was circumspection and careful review'.^[113]

35.84 Dr Alexander told the Inquiry what would happen to a donor who tested positive for HCV with the early assays:

If after 1991 a donor was found to be positive for HCV the donor was informed by the transfusion service and a recommendation was made to the general practitioner that the patient should be followed up by a hepatologist or a gastroenterologist with an interest in hepatology; for almost all transfusion centres in the UK at that time there was a list of named hepatologists who could be contacted.^[114]

35.85 Blood donors were tested prospectively. HCV-positive donors were only picked up if they returned to donate blood after the introduction of testing. At the same time people were discouraged from donating blood if they belonged to a 'high-risk group' (such as those who had a history, no matter how remote, of injecting drug use and practising homosexuals) for the safety of potential recipients, particularly following the AIDS period. As Busch had discovered in his review of HIV look-back in San Francisco, high-risk donor education programmes could lead to a dramatic reduction of infected donations as donors in high-risk groups self-deferred. Donors who had given blood in the past and were HCV positive and who did not attend after the introduction of screening in September 1991 (perhaps, high risk donors who had self-deferred) were not identified and neither were any of their corresponding recipients.^[115]

35.86 Dr Alexander's practice was to follow up donors with equivocal anti-HCV test results until third generation tests were introduced, at which point he explained that almost all of the patients in the group who had been followed up (nearly 200 at one stage) were found to be unequivocally negative for HCV and were no longer followed up.^[116]

35.87 Dr Alexander's account of the timetable of introduction of the successive stages of testing was challenged by Dr Gillon, who did not accept the section of Dr Alexander's report dealing with the use of first-generation tests in donor screening in September 1991. Dr Gillon said that he did not think that this was correct; he did not think that in any part of the UK a first-generation test was used at that stage.^[117]

35.88 As discussed more fully in Chapter 31, The Introduction of Screening of Donated Blood for Hepatitis C, a full test of second-generation kits was in operation in Scotland in the summer of 1991. Finance for the introduction of routine screening in English and Welsh regions was problematical. While on one view one can understand Dr Gillon's reservations, the position appears to be that some regions in England and Wales probably had not taken any steps to introduce screening at all, even on a research basis, prior to September 1991. Dr Alexander spoke from personal experience of the position in England and Wales and his evidence is accepted that, given the variation among regions in that part of the UK, first-generation ELISA tests were in use, at least in some regions, for up to 18 months after September 1991, notwithstanding that the second-generation test had become available in April 1991.^[118]

35.89 Scotland's position was privileged, not only in comparison with England and Wales, but internationally. In 1991 the USA was still screening with first-generation kits which had a high false positive rate.

35.90 Dr Gillon noted that the screening and follow-up of the 200 individuals mentioned by Dr Alexander was carried out with an ELISA test and RIBA 'confirmatory' test, but without the benefit of PCR testing, which was developed in Scotland by Professor Simmonds. He explained that the RIBA confirmatory test could be very difficult to interpret; there was a category of results which was referred to in Scotland as 'indeterminate' where there might be limited evidence of positivity. The SEBTS did a lot of work with Professor Simmonds and some of these intermediate positives were shown to have a true positivity by PCR testing. In Scotland, Dr Gillon's colleagues were able to 'drill' into the indeterminates using PCR. In England and Wales they would have simply remained equivocal. Dr Gillon agreed that, with the help of Professor Simmonds, his group was in a privileged position because they had access to PCR testing from 1991, in marked contrast to the position described by Dr Alexander.^[119] Dr Alexander noted:

Around 1993 and 1994 the majority of centres with a particular interest in HCV infection had introduced PCR testing, often in house, to identify the presence of HCV RNA in blood and tissue. These were of variable quality and not available to all.^[120]

35.91 Taking the evidence of Dr Alexander and Dr Gillon together, it appears that Scotland had significant advantages over at least parts of England and Wales in September 1991 that would have been relevant to commencing look-back following the introduction of donor screening:

• All Scottish RTCs had access to second-generation ELISAs and RIBA confirmatory tests. In contrast, for up to 18 months after September 1991 some regions in England and Wales continued to be dependent on first-generation ELISAs and RIBA confirmatory tests.
• Highly effective PCR testing was available in south east Scotland in particular from the beginning of routine donor screening in September 1991 but PCR tests of variable quality only reached the majority of those centres in England and Wales that had a particular interest in HCV infection around 1993 and 1994.

35.92 In using second-generation tests with ready availability of PCR testing, the SEBTS had exceptional technology, possibly unique in the UK, available to undertake look-back from the outset of donor testing in September 1991.

Scotland's ability to take unilateral action on look-back

35.93 Given the wide differences in the ability to implement look-back as described in the discussion so far, there was inevitably a question for the Inquiry as to whether Scotland could, and should, have proceeded to implement look-back at its own pace, irrespective of the difficulties English and Welsh colleagues might have experienced in following suit. As discussed below at paragraph 35.178, the legal position was resolved in December 1994 when Lord Fraser of Carmyllie, Minister of State at the Scottish Office covering home and health affairs, informed the Parliamentary Under Secretary of State at the DoH that, in the light of the medical and legal advice, he had little choice but to carry forward general look-back. His decision related to Scotland alone.^[121]

35.94 Lord Fraser of Carmyllie was Lord Advocate in 1991. He was succeeded by Lord Rodger of Earlsferry in 1992. It is extremely unlikely that, while the circumstantial context may have changed in the interval, the general principles on which legal advice available to Scottish Ministers was based would have changed between 1991 and 1994.

35.95 Professor Cash stated that he was never prepared to accept 'the notion that England can't do it and therefore we can't do it'.^[122] He saw great advantages in 'doing all sorts of things together' when possible but said that ultimately it was up to Scottish Ministers to make the decision for Scotland, although he accepted that the decision of the Scottish Ministers would be based on advice from the SNBTS. He also accepted that at this point the SNBTS policy was not to institute a look-back programme.^[123]

35.96 There is a wider context that may have had a bearing on events. As discussed in Chapter 31, The Introduction of Screening of Donated Blood for Hepatitis C, at paragraphs 31.265-31.266, the demands for blood expected to arise from the first Gulf War had persuaded Professor Cash that anti-HCV testing could not begin until the Gulf conflict had ended or SNBTS personnel had shown that they could cope with the demands of the military and testing at the same time. Dr Gillon was a member of the committee working on preparations for the war. The SHHD had commandeered a hangar at Edinburgh Airport and his RTC was filling it with blood and making preparations for receiving wounded soldiers. He agreed that the opaque expression 'national events' might have been a reference to the preparations for the war.^[124] The Gulf conflict, however, ended on 28 February 1991. At most it would have had an indirect, and reducing, impact on the capacity of the SNBTS to handle testing or look-back thereafter. Dr Gillon's alternative explanation, that the expression in Professor Cash's letter related to English reluctance to embark upon the programme in consequence of their resource difficulties, is more cogent.^[125]

35.97 There is no question as to whether Scotland could have proceeded unilaterally to implement Dr Gillon's proposals, accepting that there was a compelling ethical obligation to inform patients who might have received infected transfusions. The critical question, whether the service should have proceeded with look-back before it did so, is considerably more complex. In the end, the advice Lord Fraser received relied on medical as well as legal factors. Dr Keel confirmed that Lord Fraser was given advice by policy colleagues, medical experts and legal advisors. This was the advice upon which he based his observation that look-back was no longer simply a matter of policy but of 'legal liability', and that it should begin as soon as possible in Scotland. The ability to treat patients became one factor among others. The decisions taken were clearly influenced by the actions Dr Gillon and his colleagues took following rejection of the proposal for general look-back. It is appropriate to discuss those actions first.

The south east initiative

35.98 The rejection of the proposal for a targeted look-back programme in parallel with the introduction of screening for anti-HCV was not welcomed by the transfusion service in the SEBTS and Dr Gillon in particular, as indicated by the evidence already noted.

35.99 Dr Gillon could not remember precisely what discussions he had with Dr Brian McClelland, Director of the SEBTS, but he remembered saying to him, some time between March 1991 and the introduction of routine HCV testing in September 1991, 'Right, I am going to be doing this [look-back] and I hope you will support it', and that Dr McClelland said he would support it.^[126] Dr Gillon could not recall whether this was formally fed back to Professor Cash and he had no record of either he, or Dr McClelland, having written to the Medical Director, although he did think that they would at least have had a conversation about their intentions. He could not recall any specific discussions with other SNBTS members about his plans but recalled that the matter was discussed at a meeting of the SNBTS Donor Consultants' Group.^[127] He did not feel that he was 'hiding' the fact that he was intending to begin look-back in the SEBTS area.^[128]

35.100 Dr Gillon accepted that the whole idea of HCV look-back was a contentious issue at the time. He said that, before the start of screening in September 1991, look-back was an issue which was being debated by people in the blood transfusion community in the UK and internationally. He and his colleagues went to international meetings every year and the topic was frequently discussed. Other than a 'few relatively small countries', including the Netherlands, most countries appeared to be against the idea. Dr Gillon suggested that the reluctance on the part of the USA to introduce HCV targeted look-back was probably influential in this regard.^[129]

35.101 Between March 1991 and a symposium in Edinburgh on HCV in October 1993 (discussed below), the debate about targeted look-back was ongoing in the blood transfusion community. Dr Gillon thought that the debate probably took a back seat to some extent because the introduction of universal HCV testing of blood donations was a major preoccupation: the work of getting it in place, developing confirmatory procedures, dealing with false positives and counselling the patients who had tested positive would have kept people 'pretty busy'.^[130]

35.102 Dr Gillon confirmed that he took the decision to proceed with look-back in the knowledge that he would not be using a first-generation test.^[131] Using second-generation tests alongside confirmatory PCR testing, it became apparent that the original estimate of 0.5-0.6% of donors who would require to be followed up was reduced to less than 0.1%.^[132] There was confidence that, by that stage, if a virologist using PCR stated that a donor was HCV-positive it was likely that the diagnosis was correct. A paper published by Dr Gillon's group following the first six months' experience in south east Scotland reported 20 HCV-positive donors, a number considerably smaller than the less reliable first-generation tests would have produced.^[133]

Implementation of the south east initiative: donor call-up and counselling

35.103 Dr Gillon said that in September 1991 he simply went ahead with targeted look-back in his region, south east Scotland, an area encompassing Lothian, the Borders and Fife.^[134] The procedure was much as described above for targeted look-back generally. Donors who had been identified as positive on screening were sent a standard letter. The wording was bland but it encouraged the donor to come to see Dr Gillon's group because they wished to get a second sample to confirm the initial test result.^[135]

35.104 The initial testing was exactly the same as was being introduced throughout Scotland at the time. Every blood donation in Scotland was subjected to a (second-generation) ELISA test - a fully automated, rapid screening test. A sample of material from donations which were reactive in the screening test was sent to the Microbiology Reference Unit for further extended testing, including an ELISA test from a different manufacturer and a more sophisticated supplementary RIBA-2 test. The PCR test was also available, which looked directly for the genetic material of the virus and could resolve indeterminate cases with a very high degree of accuracy.^[136]

35.105 In the case of donors confirmed to be HCV positive who had previously donated before the introduction of screening, the look-back followed the available SNBTS data on previous donations. The first step was to identify what had happened to each of those previous donations: what components were made from them, where they were sent and what was known about their fate. Some of them would have been time-expired without being transfused, some would have been used for quality control purposes but most would have been sent to hospitals for clinical use.^[137] Dr Gillon was assisted in this part of the exercise by Dr Yasmin Ayob. Seconded to the south east Scotland RTC from the blood centre in Malaysia, Dr Ayob was a haematologist moving into a career in transfusion medicine. She provided assistance in looking at medical records, identifying the date(s) of transfusions and identifying the consultant(s) to be written to.^[138] She also helped Dr Gillon draft the preliminary report on the exercise around the end of 1992 and was the lead author of an article published in the journal Transfusion describing the SEBTS look-back exercise ('the Ayob paper').^[139]

35.106 Dr Gillon explained that for the purposes of 'recipient identification', the SEBTS had direct access to the majority of the relevant medical records because they were located in the Royal Infirmary of Edinburgh (RIE). The blood bank was under SNBTS control and Dr Gillon could obtain any patient's medical records within about 24 hours. This increased their workload in cases dealt with at the RIE. They were doing that part of the look-back exercise which, in other circumstances, would have been done by an outside hospital holding the blood bank. In cases where outside hospitals were involved, the hospitals were contacted through formal routes, informed of the facts and asked for details of the fate of the individual components: whether the component was still in stock or was time-expired and had been disposed of, or whether a patient had received it and, if so, whether the recipient patient could be identified. Dr Gillon's team would then receive a report back. Although, as noted, the arrangement in the south east region increased the workload for Dr Gillon and his team, having access to the majority of relevant medical records undoubtedly speeded up the process because certain vital information about the fate of the component and the recipient could be established from the hospital records in most cases.^[140]

Knowledge of the south east initiative

35.107 Professor Cash was unable to recall when he first found out that Dr Gillon was pursuing look-back independently in the south east region. He thought that it was probably at some point between 1992 and mid-1993 but speculated that it might have been even earlier than that.^[141] Dr Gillon thought that he had informed Professor Cash of the look-back exercise at some point between March 1991 and September 1991.^[142] Professor Cash could not remember if the SEBTS had started the look-back programme without reference to him or the MSC, but said that there came a point when the Directors of the SNBTS became generally aware of Dr Gillon's work. He was certain that he had become aware of the project, at the latest, by the date that the Ayob paper on the early experience in carrying out look-back was accepted for publication in November 1993. He recalled that it had been mentioned at an MSC meeting and that Dr Gillon was asked for a pre-publication copy.^[143] However, Professor Cash made it clear that he would defer to either Dr Brian McClelland's or Dr Gillon's recollections on the question of when he was informed.^[144]

35.108 Although Professor Cash said that the study was not 'secret', he recalled that it was his suggestion, when it became known, that it should be called a 'pilot' or 'feasibility' study so as not to 'ruffle any feathers'.^[145] He accepted that, in point of fact, when Dr Gillon's study started it was not a pilot scheme but his reaction when he first heard about Dr Gillon's work was that he was 'a little nervous' because he knew that there was opposition to the whole idea of look-back in some quarters, stating that there were 'vast amounts of sensitivity lurking around in government circles' about look-back. He thought that, if the SNBTS wanted to roll out what had been going on in Edinburgh to other parts of Scotland, they would need the support of Ministers and CMOs. It seemed to him that the best approach to describing what had been going on in Edinburgh was to label it a 'pilot scheme'.^[146]

35.109 Dr Gillon thought that the scheme was first labelled as a 'pilot scheme' either by himself and Dr McClelland together or by Professor Cash, with or without input from the pair of them. However, he noted that Professor Cash would not have so labelled the scheme unless they knew this was to happen. Dr Gillon was not unhappy to call it a 'pilot study'. He recalled, however, that at a meeting he referred to it as the 'SNBTS pilot study' and was sharply reprimanded by Professor Cash who said it was not to be regarded as the 'SNBTS' pilot study. Dr Gillon considered that Professor Cash had said that, either because he did not want to be personally associated with the exercise or because he felt that it had the potential to damage the reputation of the SNBTS. Dr Gillon was happy to go along with that as well and refer to it as the 'South East Scotland pilot study'.^[147] He noted that on instituting look-back he had expected that he might get into trouble with Professor Cash, and that he had not anticipated that it would all go 'swimmingly'.^[148]

35.110 Mr McIntosh introduced his involvement with the look-back exercise by explaining that he took a 'relatively backseat' position at the time. He went on to say that this was mainly because he considered it:

[O]ne thing that my Medical and Scientific Committee could simply absolutely be trusted to take responsibility for. So my involvement with it was very much ... I was overseeing it ... it happened on my watch. I was responsible for doing certain things to make sure that it went smoothly.^[149]

35.111 So far as the SEBTS initiative is concerned, it appears to be clear from Mr McIntosh's evidence that he had little idea of what was going on at the time. At some stage he came to understand that it was described as a 'pilot study'. Shown Dr Gillon's evidence on the establishment of his working group and the way look-back was initiated in September 1991, he realised that he had misunderstood the nature of the exercise. It had not, as he had understood at the time, begun as a pilot study and later 'became a reality'.^[150] In any event, if his evidence as a whole were to be accepted, it would not be possible to find that he did understand the background to Dr Gillon's actions in 1991 or the true nature of the look-back exercise when it was implemented. He speculated that in the light of what had happened when Newcastle began screening for Hepatitis C before the date agreed for the UK, the clinician responsible being 'practically hounded out of the profession' for it, Dr Gillon would have had good reason for his exercise having a low profile. Further, he would be concerned that the exercise should not be stopped, which Mr McIntosh thought might have been a possibility if its true nature had been disclosed.^[151]

35.112 Professor Cash could not recall what he told Mr McIntosh about Dr Gillon's programme but asserted that they did have regular briefing meetings, usually every week, and said that at the meetings anything 'that was on the go', would be discussed with Mr McIntosh. He felt that he must have told Mr McIntosh about Dr Gillon's work and was surprised to hear that, when Mr McIntosh gave evidence, he had said that he had not realised that it was not a pilot scheme at the time.^[152]

35.113 Unfortunately, there are no records available to cast any additional light on this matter. Given the sensitivity of the project, as adverted to by Professor Cash, it may be that his description of it, before it became known as a 'pilot study', was less clear than he subsequently remembered. Whatever the precise explanation for this difference in the evidence, Mr McIntosh's assertion that he did not know about the study until after it was described as a 'pilot study', and even then did not fully understand the nature of the exercise, is accepted.

Publication and reaction

35.114 The published report of the first period of study showed that screening took place between 1 September 1991 and 29 February 1992, when 42,697 donors were screened routinely.^[153] Twenty donors were identified as HCV-positive, 15 of whom had given around 63 previous infected donations among them.

35.115 Because some of the individuals who were identified had been donating for many years, the number of components was not inconsiderable - 83 in total from the 63 infected donations - but it was considered to be manageable. All of the recipients of infected components still alive, nine in total, were found to be HCV-positive. Dr Gillon said that it was a bit surprising that his group found so few recipients of infected blood or components who were alive, even at that stage of their investigations, having started look-back as rapidly as possible. Before starting the look-back they did not have any indication as to how many positive donors would turn up.^[154]

35.116 Dr Gillon thought that the paper helped to answer the question as to whether targeted look-back should be pursued nationally. He felt that it at least gave it 'a nudge' and that it must have been one of the factors that revived discussion about look-back at the various committees.^[155] In the discussion section of the paper, it was estimated that around 3300 patients might be alive and infected with HCV as a result of transfusion in the UK. Dr Gillon explained that the extrapolation was based simply on what was known about the prevalence of Hepatitis C in the donor population from the first six months of testing. This gave a figure of roughly 300 for Scotland and 3000 for the rest of the UK.^[156] The report concluded by saying: '[T]his problem should not be ignored on logistical grounds when, in each case, there is an overwhelming responsibility to the individual patient'.^[157]

35.117 Dr Gillon also referred to the finding that no recipient was alive and traceable more than five years after transfusion. Dr Gillon said that this very important finding confirmed that if one were to go back more than five years there would not be many patients at all who were still alive to be found. Broadly speaking, he considered that this would support the argument that look-back should be started as soon as possible: if there was a chance to do anything about it, it was necessary to identify the patients sooner rather than later.^[158]

35.118 The methodology adopted by the SEBTS would probably not have been feasible in the west of Scotland for logistical reasons.^[159] The advantages that the SEBTS possessed, in comparison to other regions, were that the majority of the records they required to consult were housed in one location in the Royal Infirmary of Edinburgh; they had excellent IT available; and the blood bank was under their control. In addition, they had Dr Ayob's services. The practical difficulties in the west of Scotland region are discussed in greater detail below. However, the SEBTS experience clearly demonstrated the feasibility of targeted look-back in general terms.

The workshop on HCV

35.119 Until the early 1990s, there was no treatment for HCV infection that was thought to be effective. Until such treatment became available, there was an ethically sustainable argument that it was inappropriate to tell patients that they had been, or may have been, infected, given that there was nothing that could be done to deal with their infection. However, as Dr Gillon pointed out, by the stage at which he proposed look-back there was already a body of evidence that Interferon might give some beneficial results. It was noted in the fourth and, it appears, final draft of the guidelines that: 'Progressive chronic hepatitis C has been treated successfully with Interferon, and though this treatment is at present experimental, it holds out considerable promise for the future'.^[160] There was also available a paper, from Makris and others in the north of England, about Interferon treatment.^[161] Research into treatment was a continuing concern of the pharmaceutical industry.

35.120 A workshop on HCV infection was held at the Royal College of Physicians of Edinburgh in October 1993. It had been arranged by Professor Cash. Among the speakers was Dr Geoff Dusheiko of the Royal Free Hospital, London, who gave a talk on the latest information about treatment for HCV. In retrospect, Dr Dusheiko was one of a small group of doctors claiming cure rates for Interferon which turned out later to be somewhat optimistic. However, the perception that there might be an effective cure was important in shaping opinion, and his views were relevant at the time. Asked whether he remembered, broadly, the contents of Dr Dusheiko's address, Professor Cash stated:

No, I don't but I have the memory, which may be purely spurious and something that is thought up for my convenience: I think he harangued us .... And I am almost certain in my mind - I don't have any records of this - he actually said "You should be look-backing".

Professor Cash was 'pretty sure' that he had spoken with Dr Dusheiko before the workshop and told him that, if better treatment for HCV was becoming available, he should 'plug' look-back.^[162]

35.121 Professor Cash's recollection was that Dr Dusheiko also strongly recommended instituting HCV look-back programmes. He said that it was at this point that, having been enthusiastic about look-back from the start, he now felt that the SNBTS 'could now really pursue this very hard'.^[163]

35.122 Dr Gillon also attended the workshop and presented a paper entitled 'Epidemiology of Hepatitis C'.^[164] Although he was mainly concerned with broader epidemiological issues, setting out what was known about the patterns, causes and effects of HCV for a largely non-specialist audience, Dr Gillon said that a relatively small part of his talk was concerned with his experience of look-back in the south east of Scotland. The transcript of the proceedings noted that there was a discussion after Dr Gillon presented his paper but he said that nobody asked a question about the look-back exercise. Dr Gillon stated that Dr Dusheiko did not refer to look-back in his talk and that the question of look-back did not come up in the discussion after his presentation either. It was his view that after the topic had been aired it had interested Dr Dusheiko 'and maybe one or two others there'. He recalled that Dr Dusheiko was interested in the topic from a clinical standpoint, and asked 'why isn't this happening?'.^[165]

35.123 Initially, Professor Cash recalled that Dr Gunson had attended the Edinburgh HCV workshop and had stayed overnight at his home afterwards. He also recalled being in the lecture theatre with Dr Dusheiko, by the lectern, and shouting to Dr Gunson 'come over here'. He said that Dr Gunson was 'extremely anxious' about the position taken by Dr Dusheiko. Professor Cash regarded the workshop as a watershed moment in the development of his thinking about look-back and decided that, 'We [the SNBTS] are just going to press on ourselves and see where it takes us and I'll keep Harold informed but you are on your own, Harold'. He told Dr Gunson of his decision that evening. Professor Cash was somewhat reluctant to describe Dr Gunson's reaction but said that 'the body language wasn't happy ... I think he knew in his heart they [the NBTS] couldn't deliver'.^[166]

35.124 Professor Cash was referred to a letter he wrote to SNBTS Directors dated 15 October 1993 following the workshop. The letter stated:

One of the outcomes of the recent HCV Symposium ... was that there is a need to refer patients who have recently acquired HCV infection to specialists for consideration as to whether they should have early interferon therapy.

I do believe this places an obligation on the BTS to use its best endeavours to advise clinical colleagues accordingly when we have evidence that a recipient may have acquired HCV.^[167]

It appears that the relevant 'outcome' relates to Dr Dusheiko's advocacy of Interferon therapy, strengthening the case for reverse look-back. But it does not help resolve the question whether Dr Dusheiko spoke in favour of targeted look-back in the course of his presentation (as Professor Cash maintained) or, as Dr Gillon suggested, only after the formal presentations and the discussions following thereon had finished.

35.125 Dr Keel also attended the workshop. Unfortunately, she had little memory of the event. She said that she was aware of developing interest in emerging treatment using Interferon and the idea that clinicians might at some point be able to offer treatment to patients, although she noted that it was by no means universally accepted that it was an effective treatment, with experts such as Professor Zuckerman expressing doubts.^[168] Dr Keel assumed that she had attended the morning session of the workshop and remembered Dr Dusheiko talking about treatment during the afternoon session, but could not remember the details of his presentation. She had no memory of Dr Gillon's talk and had no recollection of data from the pilot study being made available at the symposium. She was referred to the text of Dr Gillon's presentation and accepted that it was describing a look-back exercise but still had no recollection of it.^[169] She had no clear recollection either of any details about the SEBTS look-back exercise nor of any renewed emphasis being given by Professor Cash and his colleagues to the need to institute look-back by October 1993.

A change of direction: Medical and Scientific Committee meeting on 9-10 November 1993

35.126 The MSC met on 9 and 10 November 1993.^[170] Dr Mitchell, Dr McClelland, Dr Perry and Professor Cash were all present. Dr Keel was present for certain agenda items only, including item 4.6.4 headed 'Look-back HCV'. Professor Cash said that it was felt to be very important that Dr Keel was present at this meeting because, if the SNBTS wanted to take look-back forward effectively, they would have had to engage with the Scottish Office who would be advising Ministers.^[171] He explained in oral evidence that putting look-back on the agenda was an attempt at 'upping the ante'. He considered that his new attitude to look-back had been affected by the positive response he got from colleagues at the SNBTS to his letter of 15 October.^[172]

35.127 Professor Cash said that he could not remember the discussion at the meeting in detail. However, he was clear that he was arguing that the position on look-back had changed and that the SNBTS needed to begin to think about it more seriously. He was advocating look-back 'right across the board' rather than just the Edinburgh 'feasibility study'.^[173] He thought that Dr Crawford had already determined that the SNBTS could not implement look-back^[174] because he was extremely anxious at the size and the nature of the problem raised by such a programme.^[175]

35.128 Professor Cash said that he considered that this was the time to come up with 'a firm policy proposal' although after great discussion it was decided that it 'wasn't quite appropriate'.^[176] The minute of the meeting noted:

After a full discussion in which the principles of lookback of HCV PCR positive donor archive samples and appropriate communication with recipient's GPs were agreed, it was felt that the position concerning PFC products required further consideration. The Committee felt it would be inappropriate to make a policy decision at this time and that further discussion was required.^[177]

Among the documents recovered by the Inquiry was an action log following the meeting which indicated that Professor Cash was to ensure that 'look-back-HCV' received further discussion.^[178]

35.129 Although he could not recall why a policy decision was not made at that point, he speculated that it would be because other regions - Inverness, Aberdeen and Dundee but particularly the west of Scotland - would have had concerns about the difficulty of implementing look-back and would have been asking to see the 'nuts and bolts' of what had been going on in the south east region before agreeing. Professor Cash explained that Edinburgh was 'hugely well resourced'. They had a superb IT programme for the blood-bank and, in practical terms, Dr McClelland and Dr Gillon had control of over 70% of all of the clinical cross-matching in the south east of Scotland.^[179] As in that region, in Dundee, Aberdeen and Inverness the RTCs dominated the 'clinical interface' with blood transfusion. This was not the position in the west of Scotland.

35.130 Professor Cash said that Dr Mitchell, Director of the West of Scotland, 'didn't have a thing such as a blood bank' in the way other centres did.^[180] In Glasgow, the Royal Infirmary, the Western General Hospital and Stobhill Hospital each had departments of haematology with their own blood banks. These blood banks were supplied with blood by Dr Mitchell from 'a chilled warehouse in the West of Scotland', but the blood was not attached to any patient at that stage. Requests for blood in Stobhill, the Royal Infirmary Ayrshire and Fort William, for example, came in from clinical units to the local blood bank and were dealt with locally.^[181] Glasgow BTS had no blood banking IT system because they did not have overall responsibility for blood banking.

35.131 If HCV look-back were to be introduced in the west of Scotland region, Dr Mitchell would have had to rely on 'first trigger information' about possible transmission of infection generated from a very wide geographical area. Information about infective donations would have come from locations as far apart as Oban and Ayrshire and Fort William and central Glasgow, a widespread geographical area over which he had no effective overall control. This led to anxiety about 'rushing to a policy', particularly in the west. Despite the fact that screening had started in September 1991, in operational terms, if there was a look-back policy to implement, it was felt that things were going to have to be done suddenly.^[182]

35.132 Although not specifically minuted, Professor Cash stated that these concerns would have been 'ventilated very effectively' at the meeting in November 1993.^[183] Despite the outcome, Professor Cash said that by the end of the meeting his attitude was to keep going with trying to implement look-back throughout Scotland. A note in the minutes stated that Dr McClelland was to circulate look-back information.^[184] This was an early copy of the paper relating to the Edinburgh feasibility study and was to be provided to assist colleagues 'to get a feel as to what was involved'.^[185] Professor Cash explained that he wanted the Edinburgh document to be taken back to the west of Scotland BTS to be read and talked about in order to begin to put together a picture of how things might proceed there. He felt by that stage that 'as night follows day,' look-back would be implemented. Now that HCV treatment was available, the SNBTS was reaching a point where they had 'a total moral obligation' to implement look-back and the question now was how they were going to do it. At the back of his mind was that 'the Edinburgh way might not be the best for the likes of the West of Scotland'.^[186] In fact, Dr Ewa Brookes in Dundee had, since the inception of screening in 1991, also been attempting to follow up donations given by HCV positive donors who had donated prior to screening, in order to try and trace their recipients. Dr Keel recollected attending the meeting but said that although look-back was on the agenda, along with many other matters, she had no recollection of any emphasis being given by Professor Cash and his colleagues to the need to get on with look-back and was certain that no details of the SEBTS feasibility study had been revealed at that stage to her. She also did not recall getting any written information after the meeting from Brian McClelland and thought that its lack might explain why, when details of Dr Gillon's exercise had subsequently been provided to her, it had been such a revelation.^[187]

35.133 Professor Cash was referred to a letter he had written to Dr Gunson on 18 November 1993.^[188] The letter commented briefly on the Edinburgh symposium in terms suggesting that Professor Cash was providing information about the proceedings. Coupled with the fact that he did not refer to Dr Gunson having attended the symposium in the letter, Professor Cash came to doubt whether Dr Gunson actually had attended the symposium.^[189] Leaving aside the doubt cast on Professor Cash's recollection, the letter stated, with reference to the MSC meeting: 'colleagues stepped back from introducing a look-back policy until such times as further (UK) deliberations had taken place'.

35.134 The letter was copied to Dr Mitchell and Dr Perry who sat on the ACVSB/MSBT. It was also copied to Dr Keel. The letter stated: 'It occurred to me that it might be appropriate for the item to be researched for, and discussed by, MSBT. I would value your comments and support'. Professor Cash explained that his intention in writing the letter and copying it to these recipients was to speed things up by encouraging the ACVSB/MSBT to advise Ministers to proceed with look-back. He was not in a position to insist, without ACVSB/MSBT support, that look-back should proceed.^[190] As noted above, Professor Cash thought that actually delivering look-back would have required the Chief Medical Officer (CMO) or the Department of Health or Ministers to instruct health board doctors to work closely with their local transfusion service to undertake look-back. He considered that it required that level of authority and that many people shared his view. He noted that there were some clinicians who were 'not very collaborative' and several claimed they 'were far too busy'. If people were not prepared to go and find records of transfusion practice because it was a lot of extra work, it 'required a CMO ... to say "I'm instructing, in the name of the minister, that you go and do it"'. Professor Cash considered that the easiest way for the SNBTS to have look-back implemented would be for the ACVSB/MSBT to say, 'We think the time has come [for look-back], let's go'. That would have been 'immediately flashed to the Scottish Office and something could have happened'. He considered that would have been a 'great comfort' to Dr Mitchell's team.^[191] If the decision had been reached at Ministerial level, securing the extra resources to implement a programme would have been easier.

35.135 The matter was also raised by Professor Cash at the meeting of the ACTTD/I on 18 January 1994.^[192] He noted Dr Dusheiko's advocacy of look-back on the grounds of the potential benefits of Interferon treatment, especially if initiated early in the course of infection. The minutes noted support only for the concept of look-back and encouraged 'grant seeking for this potentially clinically beneficial undertaking'.^[193] Various members of the committee were to look into the issue further and report back at the next meeting.

Issues Meeting on 16 May 1994

35.136 An 'Issues Meeting' attended by members of the SNBTS and the Scottish Office was held on 16 May 1994.^[194] Dr Keel explained that Issues Meetings were set up with a view to providing a forum for discussion of issues of mutual concern. She commented that, in 1994, while Issues Meetings were more sporadic than they are today, they were not ad hoc meetings in response to specific events. They would take place when policy colleagues felt that there was enough on the agenda to make a meeting worthwhile.^[195] Professor Cash agreed that Issues Meetings were very infrequent.^[196] The SNBTS personnel in attendance on 16 May 1994 were David McIntosh, Dr Perry, Dr McClelland and, from the Scottish Office, Dr Keel, Dr Young and Mr Tucker. Dr Gillon was not present.

35.137 Dr Keel said that, from the time she joined the SHHD up until the beginning of 1994, her sense of the general attitude at the SHHD to implementing look-back was that 'we shouldn't be proceeding with it because ... it wouldn't be feasible and ... there was no really evidence-based treatment which would be effective for individuals identified with the virus'. According to her evidence, the SHHD view was informed by the SNBTS' view but also more widely by the view which had been expressed by committees south of the border, in particular the ACVSB/MSBT, and by expert opinion across the UK and abroad.^[197]

35.138 Dr Keel said that prior to the Medical and Scientific Committee (MSC) meeting on 18 May 1994^[198] she did not know that there had been a look-back exercise going on in Edinburgh and south east Scotland.^[199]

35.139 At paragraph 13 of the minute of the 16 May Issues Meeting, it is recorded that HCV look-back was discussed:

Mr McIntosh indicated that when HEP C testing of donations was introduced in 1991 it was not thought appropriate to look back over previous donations. Mr Panton confirmed that any claims for compensation following infection with Hepatitis C should be refuted. After discussion it was agreed that Mr McIntosh would send a draft policy statement about look back to the Department for clearance. This would be used in any newspaper/media enquiries received by SNBTS. (Following further developments after the meeting a meeting was arranged for Tuesday 24 May to discuss SNBTS look back proposals).^[200]

35.140 Dr Keel was referred to the comment that Mr McIntosh would send a draft policy statement about look-back to the department 'for clearance'.^[201] She had no strong recollection of a discussion about look-back although clearly it was discussed. Her clearest recollection of Dr Gillon's work was at the meeting two days after this at the MSC. Despite Mr Panton's comments about refuting claims for compensation, she did not consider that it was a major element in the department's thinking about why look-back should not go ahead. Their attitude was then based on a lack of effective treatment, logistical difficulties and lack of feasibility. Directed to the passage about media interest, she said that she had no memory of any particular media interest in look-back at that stage and was not aware from where it might have come or what might have stimulated it. At the time Dr Keel left the meeting she did not think that look-back was a 'particularly hot issue'.^[202] In his evidence Dr Gillon noted that in the 'early part of 1994' stories were beginning to appear about it in newspapers, and that the Sunday Mail, or one of the Scottish papers, made it 'into a bit of a crusade'.^[203]

35.141 In contrast to Dr Keel, Professor Cash said that he thought that the link between the look-back programme and compensation was 'chronically there'. The whole concept of liability and compensation 'lurked around in [his] memory' all the time.^[204]

Medical and Scientific Committee meeting on 18 May 1994

35.142 The MSC met on 18 May 1994.^[205] The agenda for the meeting did not include the topic of look-back.^[206] The action log, attached to the agenda, recorded that look-back HCV was then 'being discussed' by the ACTTI.^[207] Both Dr Keel and Dr Gillon were present. Under Any Other Competent Business 1, sub-heading, 'HCV lookback', the minutes set out elements of the procedure to be followed on finding a 'known' (that is, return) donor who tested anti-HCV positive.^[208] These related to re-testing archived samples and follow-up steps. It was agreed that the procedure would be based on an outline in the forthcoming publication in Transfusion of Dr Gillon's protocol (the Ayob paper) and Dr Gillon was to circulate a pre-publication copy.

35.143 In terms of follow-up procedure, the minute stated:

v. From a SHHD perspective, [Dr Keel] expressed a view that the SHHD may not have a locus in this matter and that the SNBTS should make a decision on lookback for HCV that was based on their professional judgement. However, before SNBTS took any action [Dr Keel] asked to be given the opportunity to discuss the issues with SHHD colleagues to seek their views and asked that the SNBTS take no formal action until she had subsequently contacted [Professor Cash].

vi. Once [Dr Keel] had communicated the SHHD position to [Professor Cash] and provided SHHD were in agreement that the SNBTS should implement this policy, [Professor Cash] would write to [Mr McIntosh] to provide details of the SNBTS policy, thereby allowing a decision to be taken on a starting date for the process. [Professor Cash] also would formally advise NBA, NIBTS, SACTII and MSBT of the SNBTS policy.

vii. If SHHD agreed that SNBTS should develop and implement a lookback policy for HCV, [Dr Keel] subsequently would communicate this to DOH.^[209]

35.144 Professor Cash's recollection was that Dr Keel was invited along specifically for the look-back discussion.^[210] Dr Keel disagreed: she said that it was normal for her to attend MSC meetings; she wouldn't necessarily always be there for the whole event but she would attend for part of the meeting depending on other diary commitments. She would look at the agenda in advance to decide which parts of the meeting to stay for. Generally, she tried to be there at the beginning and stay for as long as she could.^[211]

35.145 Notwithstanding the minutes, there were widely differing impressions of the proceedings at the meeting. Professor Cash considered that the Directors were saying 'we have had enough of procrastination, it's go for it time' and that this was 'game, set and match'. He felt it was a hugely important meeting because Dr Keel had expressed the view that the SHHD 'may not have a locus' with regard to look-back and that the SNBTS should make a decision on look-back for HCV based on their professional judgement. He explained that most of the SNBTS people 'fell off our seats' when they heard Dr Keel say that. They were unaccustomed to such language and, indeed, Professor Cash recalled that they had gone through a pretty painful process of instituting donation testing for HCV, when it was made 'absolutely clear' to them that the professionals could not decide themselves whether they would start testing and when they would start testing. He had assumed that the same was going to apply to HCV look-back and that it would be Ministers that would say to the Scottish transfusion service that they could 'go ahead and do it now'. The SNBTS representatives were surprised that it might be left to them.^[212] Dr Keel, the representative of the Scottish Office, now seemed to be saying, 'that's ok but ... before you do anything, let the department have just some consultation' but that once the SNBTS' 'masters [that is, the Scottish Office] had spoken' they could proceed to inform everybody what they had been told to do.^[213] He agreed with the suggestion that the SNBTS ought to 'touch base with the Scottish Office' and believed that agreement on that had been reached at the meeting.^[214] From his perspective, Professor Cash believed that by the end of the meeting the main issues to be resolved were the practicalities of introducing look-back in Scotland generally.

35.146 Dr Keel thought that if Professor Cash had indicated to her before the meeting that the SNBTS now wanted to go ahead with the look-back exercise, she would have spoken to policy colleagues before she attended it as that would have constituted a considerable change in the SNBTS' view on look-back. She explained the reasons why the Scottish Office (and the UK Government generally) did not want to proceed with look-back, and that was the policy which was in her mind before attending the meeting. If she had been given advance notice that the SNBTS was going to present her with evidence that suggested that it should be moving towards look-back, she thought it would have been obvious to her that she should have discussed it with policy colleagues in advance. No decision in government is ever taken unilaterally; decisions are corporate and advice is developed by a number of people before approaching Ministers. As far as she was concerned it would not have been the SNBTS' decision to proceed unilaterally with look-back.^[215]

35.147 Dr Keel said that, at the meeting, Dr Gillon's report had demonstrated that look-back was feasible. Although it was not minuted, she recalled that Dr Gillon gave a presentation at the meeting which, for the first time that she could remember, very explicitly laid out how he had gone about look-back in the south east region, how many people had been identified and how successful they had been in tracing recipients of blood and blood components derived from infected donors.^[216] Her recollection was that Dr Gillon's presentation provided convincing evidence of the feasibility of undertaking a look-back exercise and of tracing infected donations to recipients, and made a powerful impression on her.^[217] She became conscious of what had been going on: as far as she was concerned, this was new evidence that she needed to discuss with her colleagues. She felt that it was really a clinical judgement as to whether to go ahead with look-back. Although the SNBTS would need help with organising look-back, in 'purely professional terms', they had identified that they could do it and they were already identifying recipients of blood that was infected (in the south east region) and therefore had a duty of care to those individuals. She explained that that was why she said that the 'SHHD may not have a locus in this matter and that the SNBTS should make a decision on lookback for HCV that was based on their professional judgement'.^[218] At the meeting the MSC suggested that look-back should be pursued. Despite what Dr Keel said at the meeting about the SHHD not having a locus, she accepted that the SHHD did in fact have a locus in the matter of look-back and that one of the reasons that she said what she did was because she was relatively new in her post.^[219]

35.148 She did not agree that the minutes were accurate in noting that Professor Cash would inform the ACVSB/MSBT of a change of SNBTS policy on look-back. She would have expected him to use the SHHD or one of the SNBTS members of the ACVSB/MSBT to convey the SNBTS change in view rather than doing it directly himself.^[220] She had a recollection of someone from the SNBTS saying to her that Professor Cash was planning to phone Dr Gunson to pass on the views that she had expressed in the meeting and that the SNBTS would be going ahead with the look-back. At that point she thought she had better get back to St Andrew's House to discuss this with policy colleagues as a matter of urgency. She thought that Professor Cash was proposing to tell Dr Gunson that the SHHD had said that the SNBTS could go ahead with look-back and therefore look-back would be happening in Scotland.^[221] Dr Keel felt that this was not correct, however, and that her view was reflected in the minutes which, indeed, noted that the SNBTS was to 'take no formal action' until Dr Keel had discussed the matter with her colleagues and spoken again with Professor Cash.^[222] By the end of the May meeting, Dr Keel considered that it had been agreed that the SNBTS would wait until she had conferred with colleagues before confirming their policy on look-back.^[223]

35.149 It appears that Dr Gillon's presentation had made a great impression on Dr Keel. She explained that, when she left the meeting, she was convinced that it was now her job to convince policy colleagues that the right thing to do was to implement look-back. Dr Gillon's pilot had demonstrated its feasibility. She was also aware that treatment was now available for infected patients. She accepted, further, that the implication of the fact that look-back was feasible was that there might be some legal liability on grounds of duty of care.^[224]

35.150 Dr Keel had personally been persuaded. When she returned to St Andrew's House she discussed the question with Mr Panton. Her recollection is that both of them then went to speak to Mr Panton's senior, Mr George Tucker, and they then had a collective discussion.^[225]

35.151 At some time after this discussion, they sought legal advice on the issue of liability. The date on which they approached Scottish Office solicitors for advice is not known. Although the relevant files relating to that period were not available, her recollection was that Mr Panton organised obtaining the legal advice. Similarly, she did not know who provided the advice but Lord Fraser's letter (discussed below at paragraph 35.178) referred to it and Dr Keel spoke about it at the ACVSB/MSBT Committee. It follows that at some time between May and September 1994 she had obtained legal advice which would have come to her from a Scottish Office solicitor. Her recollection was that the advice was that, having demonstrated the feasibility of look-back, Scottish Ministers would be vulnerable if the programme was not extended across the country.^[226]

Start/Stall

35.152 As anticipated at the Issues Meeting on 16 May, (paragraph 35.139 above) there was emerging media interest. Dr Gillon noted that there were various media campaigns going on around the time that the decision was taken to start, and that the headlines that appeared were 'really quite toxic at times and damaging to the reputation of the Transfusion Service'. On 19 May 1994, Mrs Mairi Thornton, National Donor Services manager, sent an internal memo to the SNBTS board, the CSA and others. It stated:

As you may know there has been media interest in Hepatitis C. The following paper confirms our agreed position and the information is being made available to the Sunday Mail which is running an awareness campaign on Hepatitis.^[227]

35.153 The paper, dated 18 May 1994, included the following:

6) Until very recently there has been no treatment known to provide an effective cure [for Hepatitis C] and there was thought to be little benefit in the early identification of the virus in any particular individual. Therefore when routine anti Hepatitis C testing of blood donations was introduced in 1991, it was not judged medically appropriate to seek out those few patients who might have contracted the virus from a blood transfusion in the years before testing was introduced.

7) However, the BTS has kept this policy under review. Recent clinical trials now suggest that beneficial treatment for some patients with acute hepatitis C may be a possibility. The Service is, in consultation with medical colleagues, assessing if any benefits might be gained from a 'look-back' exercise.^[228]

35.154 David McIntosh sent Mr Panton a faxed letter dated 19 May 1994.^[229] It stated that the MSC 'has now formally recommended to me that the Service should implement a look-back policy without delay'. He commented that he was satisfied that the medical and scientific reasons for this, combined with good ethical and legal arguments, as well as obvious public relations implications, gave him sufficient grounds for the immediate acceptance of the MSC's recommendations, and said: 'I would therefore intend to give colleagues in England, Wales and Northern Ireland prior warning of our intentions and to activate look-back with effect from 1 June 1994'.

35.155 Dr Keel did not have a recollection of seeing the fax at the time but she considered that colleagues would have made her aware of it. She thought that she would have been surprised by the terms of the fax 'standing the discussions at the meeting' and her understanding of what had been agreed.^[230]

35.156 Professor Cash also considered that this fax was premature on the basis that it had been agreed that the SNBTS would wait to be sure that the Scottish Office would go along with it.^[231] As it turned out, the Scottish Office was unhappy about this and there was a meeting on 24 May 1994. In a fax from Mairi Thornton to the SNBTS Management Board dated 25 May, she wrote:

David ... asked me to let you know that he, John Cash, Brian McClelland, Jack Gillon and I attended a meeting at SOHHD yesterday where the SNBTS proposal for hepatitis C look-back got a sympathetic hearing.

SOHHD are to consult with the Department of Health in London before a final decision is reached, while the SNBTS is to investigate the operational aspects of introducing a look-back policy.^[232]

35.157 Professor Cash's best recollection of the 24 May meeting was that the Scottish Office officials had made it clear that the SNBTS should not go ahead until given the final instruction to do so.^[233] Dr Keel did not remember the meeting on 24 May.^[234]

35.158 This was followed by a faxed letter from David McIntosh dated 30 May 1994 and addressed to SNBTS Regional Directors in which he said:

Following our meeting in the Scottish Office on 24th May this is to confirm that official moves are now afoot to follow up the recent MSC discussions with active consideration of the steps necessary to put an appropriate look back programme into effect.

No final decision has yet been taken ....^[235]

35.159 Mr Tucker was asked to comment on the minutes of the ACVSB/MSBT of 29 September 1994 where he was noted to have said that 'approaches to institute HCV look-back in Scotland had been resisted, and it was important that a UK wide approach was adopted'.^[236] He thought it was an inaccurate report of what he had said. Mr Tucker drew attention to an internal note dated 5 October 1994 he had produced of the ACVSB/MSBT meeting where he noted he had told the meeting 'we [the SHHD] had reservations about a look-back unless it was on a UK basis and there were real benefits for patients in treatment'.^[237] He added it would not be accurate to say that the SHHD was 'resisting' attempts to introduce HCV look-back.^[238] Mr McIntosh considered that, in hindsight, the introduction of look-back in Scotland, as a whole, was delayed due to pressure from England and the natural tendency of Scottish civil servants to acquiesce to pressure from England.^[239] He was of the view, shared by Dr Gillon, Dr Keel and Professor Cash, that introducing look-back into England, Wales and Northern Ireland would be a more difficult exercise.

Towards a decision

35.160 Over the next few months the DoH appears to have sought advice from the ACTTD/I before making its recommendation. Professor Cash commented on the delay this created, saying 'we were just slightly scuppered there just for a short period of time'.^[240] By letter dated 21 June 1994 to the SNBTS Directors, and copied to Dr Keel, Professor Cash advised that the ACTTD/I was to convene an extraordinary meeting to consider look-back and that it was important for the SNBTS to consult with senior hepatologists on look-back.^[241] Professor Cash explained that Dr Gillon had come from a hepatology department and that would have made look-back easier for him in comparison, for example, to Dr Mitchell.^[242] A meeting was held within the SHHD on 21 September 1994 to discuss SNBTS issues.^[243] Dr Keel was present at the meeting along with Mr Tucker, Mr Panton and Mr Wildridge. The minutes record that she had attended a meeting of hepatologists and their view was that look-back was necessary as part of a general 'duty of care'. Dr Keel said that there was general agreement at this stage that look-back should go ahead. She could not remember if any discussions had taken place with DoH colleagues about look-back by this stage although the evidence that the SNBTS had demonstrated that look-back was feasible would have been distributed.^[244]

35.161 Dr Keel stated that it would be wrong to get the impression that look-back was starting to become less urgent. She explained that there was a desire that look-back should proceed on a UK basis. Scotland was slightly ahead of the game and there needed to be a lot of planning and advanced warning to the blood transfusion services in other parts of the UK before they could undertake look-back. She did not consider that the situation south of the border was holding up look-back being implemented in Scotland.^[245]

35.162 The ACVSB/MSBT met on 10 February 1994. The minutes of that meeting have not been recovered. But it is clear that look-back was referred to an advisory committee, the Standing Advisory Committee on Transfusion-Transmitted Infection to the MSBT (SACTTI). The SACTTI reported to the ACVSB/MSBT on 29 September 1994 when Dr Robinson presented their paper.^[246] Members of the SACTTI included Professor Cash and Dr Gillon. The recommendation was that there was a serious case for considering a look-back policy for HCV. Dr Gillon's work was not relied on in the report which dealt with the position of the National Blood Service and noted that the facilities were available to undertake tracing, counselling and referral, with a potential case load of 3000 (the number estimated by Dr Gillon at an earlier stage). The outcome on 29 September was a further postponement of any decision, with members asked to submit written comments to be considered at the next meeting.^[247]

35.163 A further Issues Meeting took place on 14 October 1994 at St Andrew's House.^[248] Those present were Mr Donald from the CSA, Mr McIntosh, Dr Perry and Mr Tucker, Mr Panton, Mr Wildridge and Dr Keel from the SHHD. It was noted that the ACVSB/MSBT were examining proposals for look-back and would return to the matter in December. It was reported that the effectiveness of Interferon therapy for HCV infection had been questioned at the meeting of the ACVSB/MSBT on 29 September 1994. Press interest was noted to be 'another potential problem'. Dr Keel and Dr Perry were noted as awaiting the decision but pointed out that 'MSBT had no real locus in this since it was not a matter of blood safety'.^[249] Dr Keel thought the comment about the MSBT (ACVSB/MSBT) not having any real locus was a 'nitpicking point' and 'not terribly material to any of the discussions that were going on'. She did not feel that this represented an attempt to 'stall' look-back and did not consider that this represented a change of view within the SHHD, but acknowledged that it would have been undesirable from a Scottish perspective if the ACVSB/MSBT had stepped in and declined to implement the policy from its position as a UK-wide advisory committee.^[250] In his evidence, Mr McIntosh said that there had been no need to take the decision back to a scientific committee at that stage. By then it was about practical matters such as logistics and computers, rather than the sorts of matters in which the committee specialised.^[251]

35.164 The MSC met on 10 November 1994.^[252] At that meeting, Professor Cash provided an update and introduced discussion on HCV look-back under reference to a report of the recommendations of the SACTTI. The report referred to an ad hoc assembly of experts held on 5 August 1994, convened specifically to discuss the feasibility of look-back, along with others including Professor Tedder, Dr Gillon, Dr Mortimer, Dr Robinson and Dr Alexander.^[253] The meeting noted, amongst other things, that, although not clinically apparent in most cases, HCV infection was not trivial, and might cause serious, progressive liver damage leading to cirrhosis and hepato-cellular carcinoma in the long term. It narrated that treatment offered early after diagnosis was mostly likely to be effective in arresting liver damage, while patients with established fibrosis and portal hypertension would not benefit. Early evidence from pilot studies showed that combination therapy with Interferon and Ribavarin might achieve virus clearance in up to 60% of patients. Interferon Alpha was not yet licensed for use in HCV infection. It was also noted that it was still not known whether therapy would affect the long-term natural history of the infection and prevent relapse after therapy was discontinued. Reference was made to the fact that when HCV screening was introduced in September 1991, look-back was not then introduced due to doubts about the long term effects of Hepatitis C, coupled with a lack of effective therapy. Furthermore, secondary transmission of HCV to sexual partners and offspring was then thought to rarely occur. The experts concluded that:

[T]here is a serious case for considering a look-back policy for HCV. To do otherwise, when a look-back programme for HIV already exists, suggests double standards. The wider implications of such a policy will need further consideration and the SACTTI recommends that the Hepatitis Advisory Group and the MSBT consider the matter further as soon as possible.^[254]

35.165 The ACVSB/MSBT met on 15 December 1994. Dr Keel was present as an observer.^[255] A report of the SACTTI recommendations on HCV look-back was presented by Dr Robinson. Discussion at that meeting was extensive. It was reported that since the last meeting of the committee, Interferon had been licensed for use in the treatment of HCV chronic liver damage.^[256] Dr Robinson's sub-committee's view was that 'there was a duty of care towards the patients who were affected, and the implicated donors'.^[257] Dr Robinson reported that it was now estimated that 60-80% of recipients who developed transfusion-transmitted HCV infection would become carriers and that 50% would develop chronic hepatitis. Twenty per cent of infected recipients might develop cirrhosis. There could be serious implications for the transfusion population.

35.166 The minute noted Dr Robinson's comments that:

The overriding view of members who commented to the subcommittee, and the view of the sub committee was that transfusion recipients, some of whom may have been harmed, would benefit from a lookback exercise. Liaison with hepatologists would be needed to ensure a consistent and harmonious approach across the UK, and the legal and ethical implications would need to be carefully considered.^[258]

35.167 Dr Metters, the chairman, commented that the lawyers would look to the committee for a view on how to carry out the duty of care. The process would aim to do what was reasonable and not go beyond that. Dr Perry commented that recognition of the duty of care was right, and that:

[T]he Committee's position needed to be clear on what had changed since 1991 to allow look back now.^[259]

35.168 Dr Robinson commented that it was only more recently that the seriousness of HCV had been recognised.^[260] Dr Metters suggested that the benefit of treatment which was becoming available, and counselling, were factors.^[261]

35.169 There were some voices of dissent. It was minuted that:

Professor Zuckerman shared the view expressed by Dr Mortimer that the question of lookback was driven by lawyers. It was important to distinguish between those infected with HCV through NHS treatment and by other means.^[262]

35.170 The practicalities of look-back were discussed. However, the CMO intervened in the debate and commented that it was in the public interest that there should be an urgent decision on the matters of principle and that the detail, though important, was less urgent. A comment from Dr Keel was noted:

Dr Keel said that the view in Scotland was that the Secretary of State was vulnerable as look back was feasible since donors could be identified and traced, and advice from Scottish Office lawyers was that look back should start immediately. The Chairman stressed the need for maintaining uniformity in the UK, but said that it was for the Secretaries of State, not the Committee to decide on whether Scotland should go ahead early.^[263]

35.171 Dr Keel explained that liability for failing to implement look-back was considered a 'material issue' at the time. Once the SHHD had received legal advice, it had to be taken seriously. She did not remember the issue of liability having dominated discussions until that point but it had now become the main determining factor in the decision to proceed with look-back.^[264] It was noted at the meeting that four writs had already been issued against the NBA and that the legal advice received was that the duty of care existed in this case.^[265]

35.172 Paragraph 7.12 of the minutes records the material decision reached at the meeting:

Following the discussion the Committee agreed its advice to Ministers as:

i. in the Committee's view there is a duty of care towards those infected with HCV as a result of NHS treatment. It follows that procedures should be put in place to identify the patients at risk;

ii. whatever is done should be done equally and uniformly throughout the UK;

iii. guidance should be drawn up as soon as possible:^[266]

35.173 At paragraph 7.13 it was noted that the Committee agreed that these conclusions would be passed on to the Secretaries of State of all four health departments.^[267]

35.174 When Dr Keel left the meeting her impression was that the UK Health Departments would advise their Ministers separately that look-back should be undertaken across the UK, that the detail was being worked out by various groups and that this would be based on the results from the south east Scotland 'pilot' study. Her impression was that look-back was now going to be put in place 'pretty quickly', as soon as the blood transfusion services could get the guidance developed and put in place in different parts of the UK.^[268]

35.175 Dr Keel stated that, while the minutes might give an impression of activity, other impressions might be drawn, reading between the lines, which suggested that perhaps things were not going to move as quickly as the SHHD might have desired. She explained that, given Scotland's different position and in view of the legal advice that they had received, there was more pressure on Scotland to move forward than might have been felt in other parts of the UK. In addition, Scotland had some practical experience of running look-back.^[269]

35.176 Professor Cash expressed views on this meeting. He was not present and Dr Metters had reminded members of their duty of confidentiality relating to advice given to Ministers. His interpretation of the course of events at this meeting was that it had been decided that there was no option but to proceed and that 'ministers should be advised to press the button and commence some form of look-back'. Of the many reasons for this, as he saw matters, one was the question of legal liability. He thought that there had been no mention of treatment, for example, though that would have been 'incorporated into the whole concept of legal liability'.^[270] It is not appropriate to comment on the stage at which legal liability might have been triggered by developing forms of treatment. Professor Cash's comment reflects his views that threat of legal liability had been a consideration at least since 1991.

35.177 Dr Keel thought that she would have come back from the ACVSB/MSBT meeting and briefed departmental colleagues between 15 and 22 December 1994. She would have prepared a note of the meeting, as was her usual habit, and would have noted that she had suggested that Scottish Ministers were vulnerable because of the legal advice that had been received. She met with colleagues to discuss getting on with look-back from a Scottish point of view. She thought that, by this stage, there was a collective view that the SHHD needed to inject a degree of urgency into the matter.^[271]

The decision in Scotland

35.178 Matters came to a head on 22 December 1994 when Lord Fraser of Carmyllie, Minister of State at the Scottish Office covering home and health affairs, wrote to Mr Tom Sackville, the Parliamentary Under Secretary of State at the DoH, intimating that, in the light of the medical and legal advice he had received, he had little choice but to carry forward general look-back which the SNBTS was prepared to implement.^[272] Mr Tucker, administrative Head of Division at the SHHD, explained that, as it was his responsibility to formulate and coordinate policy advice to Ministers based on the views of professional experts, he would have put forward a minute to Lord Fraser setting out the advice received and seeking his decision on instituting look-back in Scotland.^[273]

35.179 In 1995 a look-back exercise was commenced throughout the UK to trace patients who had received blood products from donors who were found to have tested positive for HCV.

Look-back in place

35.180 When look-back began, it identified blood donors who had tested positive for HCV in the years since testing was introduced, covering the period 1991-95. The donor would have tested positive with whichever generation of test was then available and their donation would not have been transfused or used in the preparation of blood products. Previous donations by infected donors, before testing had been introduced, would have been the focus of look-back.^[274]

35.181 The next stage of look-back was an attempt to contact all possible recipients of the infected donor's blood, or blood products, manufactured from that blood at any stage in the preceding years. In some cases that represented a large number of recipients over many years. This was done by contacting the hospital where the transfusion had taken place. Many hospital records were inadequate to match donor and recipient: in the early to mid-1990s records tended not to be retained long-term, with many records having been destroyed in the normal course of records management at the time, and there was no effective, centralised computer system matching donors and recipients. Tracking down the recipient(s) was difficult as they might have moved and there might not have been a clear record of the relevant GP to contact for follow-up.^[275]

35.182 Where a recipient was identified, a letter was sent by the transfusion service to their GP. The GP may not have had much, if any, experience with HCV and the letters to GPs were carefully drafted to encourage referral and often provided a local contact for further information.^[276] It was considered that the GP would be best placed to determine whether any follow-up of the likely infection with HCV should be undertaken or not. (Pursuing the issue of HCV infection might not be helpful for an elderly or infirm patient, or one with a life-shortening disease, for example.)^[277] It was then up to the GP to make a referral to a hepatologist or a gastroenterologist with an interest in hepatology.

35.183 Dr Alexander concluded his statement on HCV look-back by attempting to assess the overall effectiveness of the exercise:

In terms of understanding the disease the exercise has been successful. As a strategy to find all the patients with transfusion related HCV infection retrospectively it has been much less successful. For those individuals found to be positive it has had real benefit. It has allowed those individuals to be processed appropriately and in many circumstances treated effectively. It allowed a large number of them to be compensated financially for developing disease as a consequence of the transfusion.^[278]

35.184 However, professional estimates suggest that only a tiny minority of those who were exposed to HCV have been identified by way of the look-back programme. Research published in 2002 estimated that only five per cent of the total number of HCV infections over the 11-year period to September 1991 have been identified, which represented a higher proportion (13%) of those who were alive in 1995 who had received infected blood.^[279] Dr Alexander thought this was a fair assessment of the statistics available on the look-back exercise. Only a small percentage of overall HCV infections were picked up because many of the infected donors stopped coming back, perhaps discouraged by efforts to have high-risk donors remove themselves from blood panels. As he put it, 'if the whole programme is based on a donor coming back and being found to be positive and they don't come back, you are stuck'.^[280]

35.185 In addition, as Professor Cash noted (and as Dr Gillon's exercise had demonstrated several years previously), the numbers of individuals who might have been identified as carrying HCV were diminishing over the period between the introduction of screening and the introduction of look-back. Professor Cash explained that the principal reason for the attrition in terms of finding live patients to treat was death from the 'original pathology ... that had taken them to surgery'.^[281]

35.186 Dr Alexander was asked whether, with the benefit of hindsight, the look-back could have been done differently. He said:

In retrospect and with hindsight one could argue that it would have been more effective to screen all plasma samples that were available from donors (a backlog of three years for the English and longer for the Scottish). However testing this large number of samples could have crippled the transfusion service from doing its normal every day job.^[282]

The English backlog of samples from donors that could have been tested totalled more than six million in 1995. The logistics of testing retrospectively that number of stored donor samples for HCV in England alone, while continuing to run a blood transfusion service, were enormous and would have been very expensive.^[283]

35.187 In oral evidence he added this would have been 'an enormously difficult exercise' which would only have been possible with an 'enormous amount of funding'.^[284]

35.188 Both the practical effectiveness (practicability) and the cost-effectiveness (value for patients) of HCV look-back had been challenged before Dr Gillon's working group made their recommendation.^[285] Later studies, including Dr Gillon's, reported a low level of recipients of infected blood or blood components, who were alive, testable and HCV-positive.^[286] However, as Dr Gillon observed, the measurement of the cost-effectiveness of a look-back programme required monitoring of a wide range of factors relating to mortality, morbidity and prolongation of life that have only recently begun to be fully understood. One outcome of the HCV look-back exercise, the National HCV Register, has followed up as many of the patients identified in look-back as possible, providing a uniquely valuable cohort which was starting to give long-term outcomes in very precise terms.^[287]

35.189 Dr Gillon commented that Danish researchers reporting on the outcome of an HCV look-back programme in their country could demonstrate no significant benefit in terms of mortality compared to non-infected transfused patients; they had, however, shown very considerable morbidity in the HCV-infected patients, which was amenable to treatment in a great many cases. The Danish researchers noted a cure rate of close to 50% for patients who were treated with Interferon, an early indication of emerging evidence of benefit for that group of patients.^[288] Dr Gillon commented that the benefit people living with HCV obtained from treatment was an indication in favour of targeted look-back.^[289] That appears clearly to be correct: finding NHS patients who had been infected by transfusion of blood and blood components may not have achieved a high success rate, but for every patient identified and treated successfully the potential benefit was considerable.

35.190 Although a clearly measurable benefit has not yet been demonstrated in terms of overall mortality, Dr Gillon anticipated that a cost-effectiveness analysis may be carried out in the future. The Health Protection Agency Study would be extended long enough to show one way or the other whether patients did benefit.^[290]

35.191 Dr Gillon considered that further, incidental, benefits had been achieved by look-back. He considered that the UK transfusion services had regained a measure of trust with the public. There had been various media campaigns when the decision was taken to start look-back and comments adverse to the reputation of the transfusion service had emerged. It was felt to be important to calm down the atmosphere and show that the SNBTS had done something about the problem. Lessons had been learnt from look-back, as reflected in the response to variant CJD (Creutzfeldt-Jakob disease) and other problems.^[291] Dr Gillon accepted that it would have been better to have been preventative rather than reactive, but considered that things had progressed rapidly when it was eventually accepted that look-back had to be implemented.^[292]

The ethical considerations

35.192 The Inquiry had an interest in investigating why four years elapsed between the commencement of universal HCV screening for blood donors on 1 September 1991 and the introduction of the UK general look-back in mid-1995, and whether any ethical or other issues arose relative to the course of events.

35.193 Lord Fraser's letter indicated that part of the reason for lack of follow-up action on identifying infected donors had been:

[A] concern that it would be impossible to identify all recipients of infected blood and even if it were possible there was a lack of accepted treatment which would be beneficial. It was accepted that if no effective treatment was available, informing those patients who were unaware of their situation could not be justified, since this would cause further distress and anxiety without any benefit.^[293]

35.194 Against the background of changing perceptions of the doctor/patient relationship discussed in preceding chapters and, in particular, in Chapter 32, An Investigation into the Systems in Place for Informing Patients about the Risks - Ethical Context, the advice given to, and repeated by, Lord Fraser might be seen as an example of the paternalism of the 1970s. This attitude continued long after significant changes in opinion initiated by British Medical Association (BMA) and General Medical Council (GMC) publications in the late 1980s. Professor Nathanson, Director of Professional Activities at the BMA, responsible for overseeing the association's work on medical ethics and teacher at the universities of Cambridge and Durham, commented that the passage from Lord Fraser's letter was a common reason given at the time for not going ahead with a look-back programme. She said:

It has ... commonly been argued that where that information would bring them only uncertainty, where there was no treatment available, that you couldn't justify causing distress and anxiety. So that last sentence is a sentence that I would recognise as being one that has been commonly cited.^[294]

35.195 However, from a contemporary ethical perspective, Professor Nathanson asserted that individuals have a right to be told information about their health, about their own body and about infections without any qualification, including of the type set out by Lord Fraser. Further, patients aware of their diagnosis had other potential benefits. They could take steps to take care of themselves, even where no treatment was available, such as by reducing or abstaining altogether from drinking alcohol. They could also be closely monitored and be offered the opportunity of drug treatment as soon as it became available. If they were monitored, their clinicians did not lose contact and the patient would hopefully be contactable when a treatment became available. Otherwise, when drug treatment became available, the patient might be difficult to locate and valuable time would be lost.^[295]

35.196 In addition, if the medical profession does not give people information they hold about them, trust can be lost. If a patient might require unpleasant and closely monitored treatment in the future, requiring a lot of cooperation between doctor and patient, then the fact that information had previously been withheld could undermine that trust.^[296]

35.197 Less generously, it has to be noted that patients who were not informed of their exposure to virus infection were not in a position to take advice, medical or legal, on the implications of having been infected in the course of medical treatment. Lord Fraser had legal as well as medical advice in forming his views. It is appropriate to discuss the issue more fully.

35.198 It is not for this Inquiry to provide an answer, as a matter of generality, to the question when legal liability might have crystallised, having regard to the availability on general prescription of drug therapy for liver disease resulting from HCV infection. That may depend on circumstances, including the availability of a drug on a named patient basis prior to licensing, and whether the patient was, or could have been, given a choice whether to accept therapy. Professor Nathanson's evidence (paragraph 35.195) has considerable weight. Instant availability of effective therapy, and the risk of legal liability, are not the only issues relevant to look-back policy. Pharmaceutical research may result in new products, or the refinement of existing products, which are beneficial to those infected with HCV. Look-back provides an opportunity for those infected through infected donations to become aware of their condition and to benefit from such new, or refined, products.

35.199 Professor Cash stated that he strongly supported all of the reasons that Lord Fraser gave in the letter. The SEBTS study had shown that look-back was 'feasible and practicable'.^[297] Treatment for HCV was available for general prescription following licensing. And the letter acknowledged the central argument about potential liability which resulted, in his view, from these conclusions. He was referred to the section of the letter which stated that the matter of a look-back policy for HCV was considered by the ACVSB/MSBT, which had advised that procedures should be put in place to identify those at risk but that 'whatever is done should be done equally and uniformly throughout the UK'.^[298] His attention was also drawn to the passage which narrated that the advice that Lord Fraser had received from his medical and legal staff had led him to conclude that 'I consider it is no longer a matter of policy but of legal liability, and that look-back should take place as soon as possible in Scotland'.^[299] Professor Cash acknowledged that Lord Fraser was conscious that the advisory committee was not advocating immediate implementation of look-back but that, notwithstanding that, Lord Fraser was planning to go ahead with look-back in Scotland. Professor Cash again supported that approach. He accepted, by reference to this letter, that the position in 1991 when screening was introduced was that it was the Scottish Office which had responsibility for deciding whether look-back should be implemented in Scotland. He explained that that was because extra resources were going to be required, and in his view at the time it would have required a CMO letter 'to get things going'. In these respects, the position was the same in 1991 as it was at the time of Lord Fraser's letter.^[300]

35.200 Professor Cash was referred to the section of the letter which suggested that the SNBTS could be considered negligent if it did not proceed with look-back. Dr Mitchell had written to him on 14 May 1990 commenting that Glasgow and West of Scotland RTC at that time had no look-back policy, and that the Service could be considered to be negligent in not advising about potential future use of donor blood.^[301] He was asked if this was, perhaps, sounding a 'distant alarm bell'. Professor Cash said that he did not consider that Dr Mitchell was the originator of the alarm bell; he considered that everybody was beginning to think about the implications. He recalled there had been concern in September 1988 at a meeting of a group of people, who included Scottish Office lawyers, about the potential for litigation that would arise from HIV transmission by blood and blood products. Professor Cash considered that this was a landmark meeting at which people 'eventually began to talk about who had the duty of care and legal responsibility'. He explained that they had all been 'fretting' about look-back.^[302]

35.201 The stage at which legal liability crystallised with the general availability of an effective treatment for liver disease may well have been the last point at which to introduce look-back. But it cannot be concluded that that was necessarily the first stage of importance.

Discussion

Policy on look-back

35.202 From 1991, there was a clear UK transfusion service policy on HCV look-back, following the advice of the ACVSB/MSBT at its meeting on 25 February of that year. After the introduction of anti-HCV screening, look-back would 'not be undertaken as a service leaving the option for those carrying out research. However all cases of post-transfusion hepatitis should continue to be investigated'.^[303]

35.203 That was a qualification of the agreement between Professor Cash and Dr Gunson recorded in Professor Cash's letter to the Scottish Transfusion Directors dated 9 July 1990, in which it was said that investigation of donors implicated in cases of reported post-transfusion hepatitis would continue in the period before anti-HCV was introduced, but that, from that date, it would not be appropriate to introduce a systematic look-back programme on previous recipients of donations. Witnesses were agreed that the letter referred to reverse look-back and, if so interpreted, it implied a more comprehensive ban on look-back than emerged in February 1991.

35.204 It would be inappropriate, however, to apply too rigidly the definitions of look-back introduced in paragraphs 35.3 and 35.4 of this chapter. The terms 'targeted look-back' and 'reverse look-back' associated with the definitions do not appear to have been in common use in the UK transfusion service, so far as disclosed by the contemporaneous correspondence and records of committee proceedings recovered by the Inquiry. From a review of the whole evidence it is generally possible, with the benefit of expert help such as provided by Dr Gillon, or from the context in some cases, to interpret the documentary evidence and form a view whether individual documents referred to 'targeted look-back' or 'reverse look-back' as now defined. Examples have been noted in the narrative of the evidence.

35.205 However, to adopt the terminology now in use, the advice of the ACVSB/MSBT in February 1991 can be expressed in this way. Following the introduction of anti-HCV screening reverse look-back should continue as it had in the past, providing for the investigation of the source of transmitted infection where a transfusion patient had acquired HCV infection. Otherwise there should be no systematic look-back programme. On that view, systematic targeted look-back would be inconsistent with UK, including Scottish, Health Department policy from February 1991.

35.206 When Professor Cash read the guidelines prepared by Dr Gillon's group in September 1990 it would have been apparent to him that targeted look-back was proposed, and it would equally have been apparent that that was contrary to the agreement on policy he had reached with Dr Gunson and reported in July 1990. His response was that the SNBTS required to think about the issue carefully. He circulated the report to the Regional Transfusion Directors and to Mr McIntosh in anticipation of the MSC meeting of 6 November 1990. There was no representative of the SHHD at that meeting, though the BTS was represented by the Regional Transfusion Director for Leeds who spoke for Dr Gunson.^[304] In the event, the meeting did not make a decision on any matter or principle, but commissioned Dr Gillon to re-draft his proposals as Standard Operational Procedure guidelines.

35.207 The issue of principle was referred in the first instance to Dr Metters, and the SHHD and professional members of the ACVSB/MSBT were copied into the correspondence.^[305] Professor Cash's letter did not disclose Dr Gillon's recommendations. It simply invited Dr Metters to refer to the ACVSB/MSBT the SNBTS Directors' request that a policy of look-back (without further specification) be considered. Consequently, there was nothing to alert Dr McIntyre, of the SHHD, for example, to the fact that any particular departure from UK policy was in contemplation. As indicated in paragraphs 35.62-35.65, the precise sequence of events at the end of 1990 and in early 1991 remains obscure. By the meeting of the MSC on 19 February 1991 'national events' had come into play and led to agreement that no look-back should be introduced at that stage. The advice of the ACVSB/MSBT was more qualified but excluded a systematic look-back programme. That would have excluded the exercise proposed by Dr Gillon and his colleagues as contrary to UK and Scottish departmental policy on look-back. Having regard to later comments about the role of the ACVSB/MSBT in relation to look-back, it is significant that even at this early stage in events the committee was engaged in discussion as, effectively, the source of authoritative guidance on issues around look-back.

35.208 Consistently with the policy position adopted, Professor Cash wrote to Dr Gillon on 12 March 1991 advising that the guidelines should be amended to exclude the references to targeted look-back. The outcome was that Professor Cash had 'tested the water' with Dr Metters and through him the ACVSB/MSBT without disclosing Dr Gillon's proposals and without compromising the agreement he had reached with Dr Gunson.

35.209 As narrated above, when confronted with Professor Cash's letter dated 12 March 1991, Dr Gillon, with the support of Dr McClelland, resolved to go ahead with targeted look-back in the SEBTS region. This can be seen, in hindsight, as a highly principled act, in defiance of national policy, and it should be said immediately that in the view of this Inquiry Dr Gillon's actions were highly commendable.

35.210 Dr Gillon considered that the SEBTS ought, and should be able, to carry out a look-back exercise from September 1991, the date upon which donor screening for HCV was to commence. Suitable second-generation tests were becoming available and a confirmatory PCR test for HCV was in the later stages of development. From Dr Gillon's point of view, the initiatives taken in south east Scotland reflected the correct ethical response to donors following the introduction of HCV testing. It is important to note the basis for that view. His experience of the HIV era was a material consideration. In relation to HCV, the dilemma arose for him as a doctor as soon as a donation was confirmed as HCV-positive: by the following day he would have the donor's records on his desk with information showing whether there were previous donations and, therefore, whether the donor might have transmitted HCV infection. From that point he had means of obtaining access to information about previous recipients.^[306]

35.211 He accepted that there were important differences between HCV and HIV. Consequently, one could not necessarily compare the decision immediately to institute targeted look-back for HIV with the long process before a similar procedure was instituted for HCV. The health implications of positive diagnoses for the two diseases were very different. The prevention of the secondary spread of HIV, despite the absence of treatment, could have been a reason for proceeding with HIV look-back. With HCV, for a long time there was no information on its sexual transmission and once such information became available it demonstrated much lower levels of sexual transmission.^[307]

35.212 He explained, however, that to his mind 'previous donations' translated directly into 'previous recipients' and he felt that he could not in all conscience ignore that information. He saw it as part of his duty of care to the recipients of potentially infected blood to ensure that their clinicians had that information, irrespective of whether there was any treatment available at that time.^[308] Dr Gillon's views on this matter accord with the ethical duties that Professor Nathanson considered incumbent on a doctor in the doctor/patient context in the early 1990s.

35.213 Dr Gillon's first report to Professor Cash was dated 20 September 1990, and the ethical dilemma was clearly expressed in it.^[309] There were logistical difficulties, sufficient at the time to persuade the AABB that look-back should not be recommended. (However, as highlighted above, it was perceived in the USA that surrogate testing had limited the risk of infected individuals continuing to donate blood.) As noted in paragraph 35.48 above, Dr Gillon's group considered the AABB position to be untenable, given the desirability of informing recipients so that they could protect others, and also receive treatment with Interferon if the benefits of this form of therapy were confirmed.

Dr Gillon's look-back project

35.214 The screen samples used in the SEBTS exercise were obtained between 1 September 1991 and 29 February 1992. The Ayob paper reporting on the exercise in the SEBTS was published in 1994. It had been submitted for publication in November 1993 and accepted for publication on 21 July 1994. It disclosed the time taken for the exercise in terms of medical and secretarial hours. But it did not disclose the time taken for the analysis of the study for the paper or for the preparation of the report itself. However, a brief account of the project had been included in Dr Gillon's paper for the College of Physicians symposium in October 1993 (albeit mis-described). Professor Cash alerted Transfusion Directors to the need to review the policy on look-back in his letter dated 15 October 1993, with particular reference to the views of Dr Dusheiko. The MSC debated the issue at its meeting in November 1993.

35.215 By autumn 1993 therefore, it was highly likely that the SEBTS initiative would become known to a wider constituency. Subsequently, it must also have become clear to those concerned with UK and Scottish Health Department policy, as they came to appreciate what had been done, that the report related to an activity that was in fairly flagrant breach of national policy guidelines. The Ayob paper stated that UK policy, in common with American policy, was against look-back. However, before looking at the evidence relating to the official response, it is necessary to consider what was known about the SEBTS initiative between 1991 and mid 1994, and by whom.

35.216 Dr Gillon said that he thought that he informed Professor Cash of the look-back exercise at some point between March 1991 and September 1991. That evidence is accepted. Professor Cash's own recollection of events was imprecise and, in any event, he stated that he was prepared to defer to Dr Gillon on the matter. When the exercise began, it seems likely that anyone alert to what was happening in the SEBTS would have understood that some initiative was in hand. Of the 42,697 donors screened routinely, 20 were identified as HCV-positive. Fifteen had given previous donations from which 83 components had been prepared. All of these were investigated. It was a major exercise involving accessing a large number of records and involving a significant investment of time. It was not carried out in secret, and given its scale it could hardly have been clandestine, but it seems highly likely that there was no attempt to publicise the exercise while it was in progress. Dr Gillon may have informed Professor Cash of the exercise for any number of possible reasons, one of which may have been that it was a prudent precaution to take in order to ensure that there would be no interference with it once it had begun.

35.217 On the other hand, it appears likely that other SNBTS Transfusion Directors were not informed of it until at or after the October 1993 symposium, depending on whether or not they heard Dr Gillon's address. That is not surprising. As discussed throughout this report, the several regions of the SNBTS largely operated as separate autonomous organisations, each implementing their own policies which might coincide with or differ from others' on an uncoordinated basis. Professor Cash's letter of 15 October 1993 did not mention Dr Gillon's work in raising the issue of look-back with the Transfusion Directors. As matters transpired at the MSC meeting on 9-10 November 1993, the Directors wanted further information from Dr McClelland, and time to think. Accordingly, it appears likely that they had not been kept informed of the SEBTS initiative before that point. It is likely that it was as a result of that meeting that the Directors became 'generally aware' of Dr Gillon's work, in Professor Cash's words (see paragraph 35.107).

35.218 Mr McIntosh considered that he had been 'duped'. At some stage he had been informed by Professor Cash that the SEBTS was conducting a 'pilot study' of look-back procedures. Professor Cash said that he had suggested the title and his evidence on this matter is accepted. The title was devised in order to avoid questions about the SEBTS project. It is likely that it was a matter of indifference to Dr Gillon how the project was described so long as he could get on with the work. A 'pilot study' on look-back was less of a challenge to national policy than a systematic targeted look-back investigation of all anti-HCV screen positive returning donors and the recipients of blood or components obtained from their donations. Professor Cash had an interest in representing the exercise as one limited in scope. And, as Dr Gillon's anecdote at paragraph 35.109 makes apparent, Professor Cash appears to have been concerned to make it clear to others that the initiative was not an SNBTS pilot, but strictly an SEBTS matter. In his oral evidence, Professor Cash explained his position: there was a great deal of sensitivity in government circles about look-back, and opposition in some quarters. In the circumstances described, it is reasonable to infer that if action against Dr Gillon's initiative were to be avoided, it was necessary to resort to a degree of subterfuge. And it succeeded. Dr Gillon was able to proceed to complete the project without interference. The CSA, as represented by Mr McIntosh, did not understand the nature of the project, and there was no adverse reaction from any agency.

35.219 It appears likely that the SHHD had no knowledge of the project until the autumn of 1993 at the earliest. As understood by Dr Keel, the position of the SHHD from the time she joined the service until early 1994 was that Scotland should not be implementing look-back because it was not thought feasible and because there was no evidence-based therapy available for treating infected individuals. Those views were shaped and influenced by statements by the SNBTS Directors, by UK committees, and by the department's understanding of expert opinion 'across the UK and abroad'. Broadly the SHHD reasons for believing that look-back was not appropriate reflected the views of the ACVSB/MSBT.

35.220 It is apparent from Dr Keel's evidence that the feasibility of a look-back exercise in Scotland, generally, became clear to her on 18 May 1994. Several features of her recorded actions on that day demonstrate that she was unprepared for what Dr Gillon had to say. She was in error in suggesting that the SHHD might not have a locus, given their role in policy matters, but that may have resulted from her inexperience in her post. Her anxiety to return to base and discuss what she had heard with SHHD colleagues was indicative of the fact that she had come to the meeting unprepared by such discussion in advance of the meeting.

35.221 It is slightly less easy to understand why Dr Keel should have been in that position. Dr Keel was at the October symposium at which look-back was aired, to some extent at least, by Dr Gillon. Even if one discounts Professor Cash's more exuberant observations on the impact of Dr Dusheiko's contribution, Dr Gillon's paper did disclose that look-back had been explored in the SESBT region. However, it may be, as Dr Gillon suggested, that despite his airing of the subject only Dr Dusheiko and 'one or two others' had their interest caught by it. Professor Cash, who had arranged the symposium and, apparently, had a particular interest in look-back at the time, also had no recollection of the subject matter of Dr Gillon's talk. Dr Keel was not copied in on Professor Cash's letter of 15 October 1993 to transfusion colleagues, which indicates that he was not then ready to open up the policy issue directly with SHHD colleagues before he had discussed it at the MSC. However, Dr Keel was present at the MSC discussion.

35.222 The MSC discussed look-back on 10 November 1993, as anticipated in Professor Cash's letter. The minute of that meeting records that full discussion took place of what was clearly a targeted look-back scheme (see paragraph 35.128). Dr Keel is recorded as having been present for item 4.6 which included the discussion of 'Lookback: HCV' as a new agenda item but Dr Gillon was not present. Consequently no presentation by him, such as Dr Keel witnessed on 18 May 1994, was then made. The record indicates clearly that, while decision was postponed, what had been envisaged was a policy decision on the item. It may be that the consensus to postpone the decision together with the concerns expressed by the directors in relation to the potential difficulties with the practicalities likely to be encountered in Inverness, Aberdeen, Dundee and the west of Scotland reinforced her then extant view that look-back was not feasible for Scotland as a whole or considered an urgent matter. Undoubtedly, the SEBTS was uniquely well-placed within Scotland to carry out a look-back exercise due to its blood banking system, the expert assistance available to it and the IT resources that it commanded. The action log following from the meeting, which provided background to the agenda for the meeting on 18 May 1994,^[310] indicated that Professor Cash was to ensure that 'look-back-HCV' received further discussion. The 'Discussion Topics For Future MSC Meetings', attached to the agenda for the 18 May 1994 meeting, included 'HCV confirmed positive donors-look-back'.^[311] No name or initials were provided for any 'presenter' and no priority rating had been allotted to the item. The action log, also attached to the agenda of 18 May 1994, suggested that the ACTTD/I were then discussing look-back. The SHHD was not represented on the ACTTD/I. Dr Keel was at the issues meeting on 16 May 1994. At that meeting targeted look-back was discussed. The minute records that Mr McIntosh would send a draft policy statement to the Department for clearance.

35.223 If Dr Keel had sought the advice of other medical and policy colleagues before the meeting of 18 May, it seems reasonable to speculate that, despite her relative inexperience, she would not have inadvertently misrepresented the SHHD position at it. However, in the absence of any reference to HCV look-back on the agenda, it is not surprising that she did not consider that there was any need to do so. At the meeting on 24 May, arranged after the issues meeting of 16 May 'following further developments after the meeting', it was indicated that the SNBTS proposals for targeted look-back got a sympathetic hearing, but the decision was that the DoH would be consulted before a final decision was reached. Notwithstanding the impact of Dr Gillon's presentation, the SHHD still required to consult with the DoH and it seems likely that that would have been the attitude of SHHD officials whenever confronted with SNBTS proposals for targeted look-back.

35.224 It is worth noting that in the autumn of 1993, Professor Cash's approach to targeted look-back, in recorded exchanges, appears to have been decidedly low-key. The records of the MSC meetings of November 1993 and May 1994 indicate clearly that, within the SNBTS community, Professor Cash was at pains to ensure that look-back was kept on the agenda. However, there is no indication in any of the correspondence that he was a passionate advocate held in check by more cautious transfusion directors.

35.225 At the meeting of the ACTTD/I on 18 January 1994, Professor Cash explicitly relied on Dr Dusheiko's advocacy of targeted look-back. He did not then disclose Dr Gillon's completed work, and his proposal for action emphasised the need for research, probably involving a research grant application. Interestingly, it was remitted to Professor Tedder and Dr Barbara to examine protocol options for look-back. Scottish experience and capacity were not mentioned. But a corner had been turned: the committee supported the concept and encouraged grant seeking for the undertaking. It is against this background that the proceedings of the MSC on 18 May 1994 have to be considered, and the wider publication of Dr Gillon's programme has to be understood. It was, at very least, consistent with the thrust of the decision of the ACTTD/I, though not as yet the ACVSB/MSBT.

35.226 The ACVSB/MSBT met on 10 February 1994. The minutes of that meeting have not been recovered. But it is clear that the matter was referred to the SACTTI. On 29 September 1994, Dr Robinson presented the SACTTI recommendations to the ACVSB/MSBT. Members of the SACTTI included Professor Cash and Dr Gillon. The recommendation was that there was a serious case for considering a look-back policy for HCV. Dr Gillon's work was not relied on in the report which dealt with the position of the NBTS and noted that the facilities were available to undertake tracing, counselling and referral, with a potential case load of 3000 (the number estimated by Dr Gillon for the rest of UK other than Scotland). The outcome on 29 September 1994 was a further postponement of any decision for members to submit written comments. The disposal of the issue of principle took place at the next meeting of the ACVSB/MSBT on 15 December 1994, and is narrated in paragraphs 35.165-35.173. Practical implementation of look-back was in the event accelerated by the actions of Lord Fraser of Carmyllie on 22 December 1994, and took place in 1995.

Earlier implement of targeted look-back in Scotland

35.227 Lord Fraser of Carmyllie's letter answers conclusively the question whether Scotland was prevented by wider UK policy considerations from proceeding with targeted look-back from 1 September 1991. The Inquiry was not directed to any change in the law between 1990 and December 1994 that would have had a bearing on the advice Lord Fraser might have had from his legal advisers on the obligation to pursue look-back. There may, however, be questions as to whether the factual, circumstantial, context had changed over that period such as might have affected the enforceability of the general duty of care. Any relevant questions would then have related to the known facts, including those relating to the feasibility of look-back in Scotland. Crucial facts would have included:

• The reliability of available screening tests.
• The traceability of prior donations by a donor testing positive for anti-HCV after confirmation testing.
• The identification of potentially infective prior donations.
• The traceability of recipients of those donations.
• The availability or likely availability of treatment.

35.228 The logistical difficulties associated with look-back have been rehearsed above: they were real and substantial and, as events were to prove, the relative failure of look-back when it was implemented was in part due to those difficulties. But by 1 September 1991, Scotland was in a particularly favourable position. The use of first-generation screening tests might have caused difficulties in some regions of England and Wales, as would the late and patchy availability of PCR tests, as described by Dr Alexander. However, prior to the introduction of routine screening in September 1991, it was known in Scotland, firstly, that the more sensitive and specific second-generation ELISA tests would be available for routine screening and, secondly, that the RIBA confirmatory tests would also then be available. Furthermore, Professor Simmonds' PCR test was known to be available from the turn of 1990-91. As Dr Gillon explained, Scotland was one of the very few countries, and might have been the only country, that had PCR testing available as part of their confirmatory algorithm right from the outset, substantially ensuring reliable diagnosis for those found positive. When a donor was confirmed anti-HCV positive after 1 September 1991, they knew they were positive and this together with the excellent IT resources, assistance and blood banking system put the south east region of Scotland where Dr Gillon operated, in a particularly favourable, and possibly unique, position to initiate look-back from the very outset of screening as he had advocated. However, that was not the case for the rest of Scotland as became apparent at the MSC meeting at the end of 1993. A number of logistical difficulties, some of which are likely to have been exacerbated by the passage of time, had to be overcome when the UK look-back exercise began in 1995.

35.229 Whenever precisely the feasibility of a look-back exercise in Scotland as a whole was, or should have been, established, a further matter which requires to be addressed relates to the availability of effective treatment. On his own evidence, Professor Cash, among others, became convinced of the inevitability of a look-back exercise as a result of Dr Dusheiko's address at the HCV symposium in October 1993 at which the use of Interferon was advocated as an effective therapy. Even if, contrary to the views of Professor Nathanson and Dr Gillon, the availability of a remedy could legitimately be considered central to the policy issue, there was strong evidence from that point onwards that Interferon was a possible candidate. However, at the MSC meeting in November 1994 Professor Cash reported on the discussions at the SACTTI, which included those relating to the early results of the Interferon and Ribavarin combination pilot study, the lack of a licence for Interferon and the lack of evidence as to whether the therapy would affect the long term natural history of the condition, including preventing relapse after therapy was discontinued.

35.230 Further, it is a material consideration that Interferon was not licensed until November 1994. The licensing procedure did not prevent the use of the drug on a named patient basis, and Dr Dusheiko made it clear that there had been extensive use of it. On the other hand, it is highly unlikely that the SHHD or the DoH would, or could, have formulated and implemented a national policy that depended on treatment with the use of a drug that was still in the course of assessment by the Committee on Safety of Medicines as part of the licensing procedure. Apart from any risk to patients, the integrity of the licensing procedure itself would have been challenged if either had done so. Whether a decision on licensing of Interferon could have been accelerated would depend on pure speculation.

35.231 As matters transpired, the Chief Medical Officer's intervention at the meeting of the ACVSB/MSTB on 15 December 1994, and Lord Fraser's letter to Mr Sackville on 22 December 1994 followed the licensing of Interferon. On all the evidence available to the Inquiry, it is not possible to conclude that an earlier decision on UK-wide or Scottish policy could have been reached.

35.232 It is unfortunate that matters were so long drawn out. Time was the enemy of effective identification of patients who might benefit from management that took account of their infection. Not only was there a risk of progression beyond the stage at which intervention by therapy was likely to be effective, but patients also were lost through death or the breakdown of communication links. However, it must also be borne in mind, as Dr Gillon noted in his evidence, that the look-back exercise undertaken in 1995 in the UK was one of the earliest comprehensive look-backs instituted in the world

Conclusions

35.233 Targeted look-back could not have begun before the commencement of routine screening. In Chapter 31, The Introduction of Screening of Donated Blood for Hepatitis C, it is concluded that a decision to recommend to Scottish Ministers that government policy should include a commitment to routine screening of blood donations for anti-HCV should have been taken by the middle of May 1990, with implementation unlikely much before autumn 1990, having regard to the supplies of test kits available.

35.234 There were no scientific or medical grounds on which routine screening of blood donations in Scotland required to be started simultaneously with the rest of the UK. Successive delays in the uniform start date were influenced largely by problems relating to introducing screening in England and Wales, which had no parallel in Scotland. Scottish Office Health Ministers and the Secretary of State were not informed that financial and other problems affecting only England and Wales were delaying the start date, and advised that the policy of a uniform start date ought to be reviewed. Action, or inaction, on the part of a number of individuals (as more fully set out in Chapter 31) resulted in the opportunity being lost for a more prompt introduction of screening in Scotland. Consequently, Scottish patients lost, firstly, the benefit that would have accrued to them from the early introduction of screening and, secondly, the reduction in the risk of acquiring HCV by transfusion of unscreened, infected blood. What Scottish Office Health Ministers or the Secretary of State would have done with such information can only be a matter of speculation, but in its absence they were deprived of the opportunity to consider the issue and resolve it as they saw fit. In the event, 1 September 1991 became the earliest date at which look-back could have been commenced.

35.235 If routine screening had been introduced earlier in Scotland, Dr Gillon would probably have gone ahead with the SEBTS project earlier, and the feasibility of look-back for the SEBTS at least would probably have been established earlier. However, as Dr Gillon noted, the work involved in the introduction of universal screening put the look-back debate on the back seat as the development of confirmatory procedures, time required to deal with false positives and the counselling of genuine positives kept people 'pretty busy'. That consideration would have applied whenever screening was introduced. In any event, none of these matters would have affected the licensing process for Interferon. Though from the introduction of Interferon treatment on a named patient basis in England in 1989 and in Scotland in 1990, therapeutic use was a reality, and there was the prospect of improved products being introduced in the ordinary course of research and development by pharmaceutical companies, the licensing of the product was an unavoidable aspect of the regulatory regime in the UK and applied in Scotland as it did in the rest of the UK.

35.236 At the ACVSB/MSBT meeting in December 1994, Dr Perry expressed his concern that the committee should make clear what had changed between 1991 and that meeting to justify the decision on 15 December to 'allow look-back now'. The report of Dr Robinson's sub-committee provides part of the answer, so far as the ACVSB/MSBT is concerned.^[312] However, the Inquiry does not have sufficient evidence about the situation in England and Wales to provide an analysis or critique of the deliberations and decisions of the ACVSB/MSBT in relation to those parts of the UK over this critical period. So far as Scotland is concerned, Dr Keel emphasised that the ACVSB/MSBT was the principal UK Advisory Committee and that it would have been the committee that the SHHD 'would have looked to for a steer on this look-back'.^[313] It is clear, however, that the sequence of events leading up to Lord Fraser's initiative did not reflect the outcome of requests from the SHHD for advice from the ACVSB/MSBT. On this occasion, Lord Fraser proceeded on Scottish advice.

35.237 Lord Fraser's letter simply reflected the independent obligation of the Scottish Office Health Ministers to act in the best interests of Scottish patients, an obligation that existed throughout the relevant period and beyond. The clear expression of the legal obligation was not a new factor: the advice of law officers on that issue would have been the same whenever the question was put to them. As far as medical advice is concerned, Dr Keel was the main medical advisor at this point in time. She provided counsel on the medical and clinical benefits of look-back. Her own view had been formed by meetings that took place in the months preceding Lord Fraser's letter, as well as by SNBTS advice, particularly in relation to the SEBTS study. Latterly, she had also met with experts including hepatologists. In May 1994 she, and thereafter the SHHD, became convinced that look-back should be carried out in Scotland as a whole, and the SNBTS and the SHHD worked towards that end.

35.238 The potential seriousness of NANB Hepatitis, and therefore of HCV infection, had been established in the second half of the 1980s. The suggestion at the ACVSB/MSBT meeting on 15 December 1994, reported at paragraph 35.168 above, that it was 'recently' recognised that HCV was potentially a serious condition is inconsistent with the evidence obtained by the Inquiry. The research of Dr Hay's Sheffield group using biopsy showing a high prevalence of serious morbidity in patients with NANB Hepatitis infection, was published in 1985. The Sheffield findings did not become generally accepted opinion immediately. However, the analysis of the clinical manifestations of infection in the eighth edition of Sherlock's Diseases of the Liver and Biliary System, 1989, and indeed Professor Zuckerman's 1988 paper on 'Unresolved issues in non-A, non-B hepatitis' reflected the general acceptance by 1989 of the potential seriousness of NANB Hepatitis/HCV infection.^[314] The topic is discussed in Chapter 15, Knowledge of Viral Hepatitis 2 - 1975 to 1985 and Chapter 16, Knowledge of Viral Hepatitis 3 - 1986 Onwards.

35.239 The feasibility of look-back for Scotland as a whole was accepted by mid-1994, and the potential seriousness of the infection had been acknowledged before the beginning of that decade. The logistics of the look-back exercise were burdensome, partly because of problems with record-keeping and the limitations in the computer systems then available, both of which contributed to the difficulty in tracing patients - not an easy task in itself as a result of name changes and changes of address. But those difficulties had to be resolved in 1995, and the resolution of them is unlikely to have become less difficult with the passage of time. The effectiveness of the treatment, or treatments, available for HCV continued to be discussed by expert committees until almost the end of 1994.

35.240 In 1993 and 1994 Interferon therapy was controversial. It is not clear that very many individuals, in fact, lost a chance of treatment. It was widely held that the prospects of effective treatment with Interferon, certainly alone, were poor. Furthermore, treatment was unpleasant and poorly tolerated by patients. However, as any treatment options developed, in terms of the range of product and their effectiveness, information of HCV status would have been of interest to patients and might have affected their receptivity to treatment, notwithstanding the risk of side-effects. For patients who were informed of their exposure to HCV, such information might have encouraged them to abstain from alcohol entirely, or reduce their consumption of it, and adopt a different lifestyle despite the absence of effective treatment for their condition.

35.241 So far as the direct responsibility of Scottish Ministers is concerned, Lord Fraser of Carmyllie responded with reasonable speed to the advice tendered by Dr Keel and her legal colleagues. That was advice generated in Scotland, and underscored the responsibility of Scottish Ministers for health policy north of the border. However, in the final analysis, the availability of safe and effective treatment was always going to be a crucial factor. The SACTTI report presented to the ACVSB/MSBT on 10 November 1994 did not resolve matters to the satisfaction of that expert committee. Only when Interferon was licensed in November 1994 was the way clear. In all the circumstances prevailing, it cannot be said that look-back should have been introduced generally in Scotland before November 1994.

35.242 As concluded in Chapter 3, Statistics, the investigations made by the Inquiry suggest that further epidemiological study will not produce a more reliable estimate of the number of people in Scotland who have been infected with HCV as a result of transfusion with blood or blood components. The number infected can only be estimated, and the Inquiry's best estimate can be found in Table 3.21 of that chapter. Whatever the number, every one of those still alive is likely to benefit from identification, testing and treatment. Some may have already so benefitted, but others will not have done so. Accordingly, the more pressing practical problem is how to identify all of those so infected in order to ensure that all may be offered effective medical care.

35.243 The SNBTS look-back exercise, described in this chapter, ran until 1998 using data available following the introduction of anti-HCV screening in September 1991. That look-back exercise had necessary limitations. First, any HCV positive donors who had donated before screening began would not be screened unless they returned to donate after September 1991. Secondly, the look-back study lacked the highly efficient patient tracking systems available today. Early donor card records were not searchable and different transfusion centres and hospitals had different record keeping systems. Difficulties were encountered in cross referencing donation numbers and recipients and vice a versa. Medical records had been lost or destroyed. Some recipients had changed their names through marriage or other causes. Some recipients had changed addresses.

35.244 Due to the inevitable limitations of the look-back exercise as described above, there will still be recipients of HCV positive blood who remained, or remain, unaware of that fact. Some of those will have cleared the virus naturally. Some will have died either as a result of age, the life-threatening condition that resulted in transfusion being required, HCV itself or from other causes. However, a number of the recipients will not have cleared the virus, will be alive and at risk of the disease progressing and of infecting others. Some of those who are symptomatic among that group may have sought medical attention, have had their condition diagnosed and be receiving treatment for it. However, a number will remain who are either asymptomatic or whose condition has not yet been diagnosed despite their symptoms, particularly if they received a transfusion in the years leading up to the introduction of screening. Dr Mutimer, Consultant Hepatologist, suggested that the median time from infection to cirrhosis in younger patients was about 30 years.

35.246 Significant symptoms are likely to manifest themselves as the condition progresses. Treatment is available which might arrest the development of the disease, and it tends to be more effective if given prior to the onset of cirrhosis and related complications. Attempts have been made to alert individuals thought to be at risk of HCV through a number of government initiatives including the Hepatitis C Action Plan for Scotland.^[315] That plan has been much praised and was described by the World Hepatitis Alliance recently as 'a model of best practice'.^[316] On 25 August 2011 the Scottish Government brought together sexual health, HIV, Hepatitis C and Hepatitis B into the Sexual Health and Blood Borne Virus Framework 2011-2015.^[317] The framework built on the success of the Hepatitis C Action Plan for Scotland: Phase II^[318] and Respect and Responsibility^[319] as well as further developing the HIV Action Plan in Scotland.^[320] However, as the majority of Scottish patients suffering from HCV have tended, historically, to become infected through drug use, the bulk of the practical measures outlined in the Action Plan and in the Framework are aimed at that cohort. Unfortunately, a stigma is attached to the condition in consequence of its drug related and substance abuse association, and the framework acknowledges that raising awareness of Hepatitis C among health professionals is also a significant challenge.

35.247 Patients with bleeding disorders, registered with UKHCDO on the National Haemophilia Database, are also affected by the transmission of HCV. They are a well-defined group of individuals. Those who test HCV positive are being managed by, and receiving treatment from, haemophilia clinicians and other specialists as required. Their condition is subject to routine monitoring including by liver function tests.

35.248 The transfusion patients have only one common characteristic namely that they received an infected transfusion at some date prior to September 1991 in the course of medical or surgical treatment. As previously indicated, not all recipients of HCV positive blood were traced by the look-back exercise. There are therefore individuals who may well remain unaware of their HCV positive status. Any measures designed to reach those suffering drug use-related HCV are less likely to reach, or identify, these individuals. These people are, however, likely to benefit from testing and, if appropriate, modern anti-viral treatment.

Recommendation

The Inquiry recommends:

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.

Appendix 1: Inquiry Procedures >