THE PENROSE INQUIRY
Final Report

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Chapter 31

The Introduction of Screening of Donated Blood for Hepatitis C

Introduction

31.1 This chapter concerns the introduction of screening for antibodies to the Hepatitis C virus (HCV) in the blood donor population in Scotland. It will follow the progress towards and up to the introduction of UK-wide screening on 1 September 1991.

31.2 The relevant period began when the Chiron Corporation of California announced in May 1988 that it had isolated and cloned a protein of the blood-borne non-A, non-B Hepatitis (NANB Hepatitis) virus. At the same time, Chiron was working to develop and release tests to detect antibodies to the virus, which in time became known, as the Hepatitis C virus. First generation tests were made available to other parties from 1989. The availability of antibody test kits opened the way for scientists such as virologists and transfusionists to assess and try to understand the tests and to gauge their value and usefulness in screening blood donations quickly, effectively and accurately, and counselling potentially large numbers of donors. Developing knowledge provided policy makers and their advisers, at government and institutional levels, with information required to formulate and implement policies on the introduction of screening. This chapter will discuss the chronological development of government policy by examining the work of the government's in-house advisers and independent advisory committees.

31.3 The introduction of screening for antibodies to HCV (anti-HCV) was initially examined in Chapter 9 of the Preliminary Report in paragraphs 9.87 to 9.291. Since that section was written, the Inquiry has examined more written documentation on this topic and gathered more information on the background to screening, as well as heard a great deal of oral evidence. This chapter will therefore set out a fuller and more focused account of the introduction of screening than was possible in the Preliminary Report.

Hearings of evidence

31.4 The interval between the availability of tests for the Hepatitis C virus in 1989 and the introduction of screening of donated blood for the virus in the United Kingdom in September 1991 was identified as a topic requiring to be considered at the Oral Hearings of the Inquiry.

31.5 All the witnesses who gave evidence to the Inquiry on the topic, in writing or at Oral Hearings, were asked to consider a standard list of questions.^[1] The standard list of questions was accompanied by an 'extended narrative'. This consisted of the paragraphs of the Preliminary Report from 9.247 to 9.283, with insertions to reflect material discovered after publication of that report.^[2]

Chiron's breakthrough in May 1988

31.6 The factual background to Chiron's discovery, and its role in defining the aetiology of Hepatitis C, are narrated in Chapter 16, Knowledge of Viral Hepatitis 3 - 1986 Onwards. In the initial announcement of the discovery on 10 May 1988, it was stated that Chiron had developed a prototype immunoassay that might lead to a screening test for non-A, non-B Hepatitis virus antibodies.^[3] In this chapter there is further discussion of the development and marketing of Chiron's assay, but it is appropriate first to set the scene with a brief summary of the developing picture.

31.7 Chiron claimed that its research team had discovered 'a long-sought blood-borne hepatitis non-A non-B virus', not the virus that caused NANB Hepatitis, implicitly acknowledging the understanding at that time that there might be other causes of NANB Hepatitis. The development of immuno-diagnostic products for screening for NANB Hepatitis antibodies was advertised as a possibility, though it was emphasised that Ortho Diagnostic Systems, a subsidiary of Johnson & Johnson, would market any products which were developed.^[4] The proprietary claims for intellectual property rights in and derived from the discovery were intimated at the outset. Some parts of the press release were more concerned with marketing than scientific accuracy.^[5] Typically, the information published was less than explicit in disclosing the science underlying the discovery.

31.8 The Chiron research team had not isolated and cloned the whole virus. Later research would show that the significant entity that had been identified, and specifically targeted by the tests tentatively announced by Chiron at this stage, was limited to one of the proteins of the virus, identified as the NS4 protein.^[6] Not all genetic types of HCV have NS4 proteins. Limitations on the usefulness of a potential Ortho test related to this characteristic were noted as discussion of the adoption of the test progressed, and would emerge in practice when it first became available. In the meantime, however, Chiron's press release was optimistic in tone and the claim of the effectiveness of the proposed test was broad.

31.9 In explaining briefly how the test would be used, the press release stated:

[B]lood banks will be able to apply a relatively simple assay procedure, using a plate coated with the virus protein, to screen for blood infected with hepatitis non-A, non-B virus. Antibodies from the infected blood bind to the plate, which is then rinsed - if the antibodies are present, a second coating of indicator antibodies will signal a color.^[7]

31.10 Just over a week after the initial announcement, on 19 May 1988, a shorter article containing similar information appeared in the journal Nature.^[8] The journalist who wrote the piece in Nature appears to have drawn on the Chiron press release as source material.

31.11 The announcement of the Chiron research was repeated in the journal of the American Association of Blood Banks (AABB), Blood Bank Week, dated 13 May 1988.^[9] The comments published were cautious, reflecting a degree of scepticism in the absence of scientific details.

31.12 The Blood Bank Week article gave further details of the test kit that was in development:

Chiron Corp. of Emeryville, CA, is submitting a screening test (ELISA) to detect antibodies to the viral particles, to the Food and Drug Administration for approval. The test, if approved, could prevent patients from receiving infected blood and help reduce the amount of blood discarded, possibly eliminating the need for the surrogate tests currently used, ALT and anti-HBc.^[10]

31.13 This information indicated a change of direction. Dr Brian Dow commented that when Chiron isolated their protein clone they used a radio immuno-assay (RIA) and reported on that in various papers in 1989, but it was never marketed.^[11] Instead, the test was developed as the enzyme-linked immuno-assay (ELISA), which Ortho proceeded to market, as anticipated in the article.

31.14 The Blood Bank Week article became a topic for discussion at the SNBTS Directors meeting on 14 June 1988. It was noted that Ortho Diagnostic Systems would soon market an ELISA test for NANB antibody. It was agreed that Professor John Cash would contact Ortho to enquire about the availability of the test in the UK.^[12]

31.15 Scientific details of the discovery were not released until April 1989 when two articles were published in the journal Science. The first article described the isolation by Chiron of a cloned protein derived from NANB Hepatitis.^[13] The second, published in the same edition, gave details of the specific screening test developed to detect antibodies to the NANB Hepatitis virus that Chiron had discovered.^[14] How that was achieved is described in Chapter 16; Knowledge of Viral Hepatitis 3 - 1986 Onwards, paragraphs 16.22-16.26. The Choo article in Science designated the hepatitis virus isolated by Chiron as 'hepatitis C' or 'HCV' and identified it as a major cause of both community-acquired and post-transfusion NANB Hepatitis, while recognising that other agents might be involved in transmitting NANB Hepatitis.^[15]

Professor Cash contacts Ortho

31.16 On 5 July 1988, Professor Cash wrote to Dr Ginger Rosenberg of Chiron in the USA, asking for access, in due course, to some of their kits for SNBTS to evaluate.^[16]

31.17 On the same date, Professor Cash also wrote to Ortho in England seeking confirmation that Ortho would be marketing the recently announced Chiron kit. In addition, he asked when the kit would be marketed in the UK for full donation testing.^[17]

31.18 Mr Follett, of Ortho UK, replied to Professor Cash on 19 July:

Ortho ... do have an agreement with Chiron to develop and market the product but I do not know precisely when this product will be available. The best information I have been able to obtain is that the product may be available towards the end of 1989.^[18]

31.19 Mr Follett emphasised that there was a great deal of work to do regarding manufacturing and trials before the product would be available. There was a noticeable gap of time between the Ortho letter to Professor Cash of July 1988 and the suggested availability of the test in late 1989. While 12 months to develop an assay might appear to be quite a long time, Dr Dow commented in oral evidence that it probably takes longer nowadays to develop something into a useable assay that can be launched commercially.^[19] In the event, Ortho had supplies of its first generation ELISA available for sale for 'in vitro diagnostic use' at the end of November 1989, as forecast.^[20]

UK Health Departments^[21] discussion of need for a new advisory group, July 1988

31.20 When Chiron made its announcement in May 1988, the United Kingdom Government did not have an advisory body competent to provide an assessment of the possible value of the American research, and in particular of the usefulness of the ELISA test in screening blood donors, as an aid to informing policy.

31.21 Early in 1988 Dr Harold Gunson (Consultant Advisor to the Blood Transfusion Service in England and Wales)^[22] had discussed with Dr Brian McClelland (SNBTS Regional Director, Edinburgh and SE Scotland Blood Transfusion Service) and Dr Hilary Pickles (DoH) the formation of a UK group to determine policy with respect to transfusion-transmitted diseases.^[23] There appears to have been no progress with the proposal until July 1988.

31.22 Coincidentally, and apparently separately from the above, on 14 July 1988 Dr E L Harris (Deputy Chief Medical Officer, England and Wales), sent a memorandum to various officials in the Health Departments, including Dr John Forrester (SHHD), proposing the creation of a group with a wide remit, an Advisory Committee on the Virological Safety of Blood (ACVSB).^[24] It noted that concerns had been raised at a recent meeting of the Expert Advisory Group on Aids (EAGA) about the lack of advice available to ensure, generally, the virological safety of blood in the UK. Since viruses other than HIV1 and HIV2 were involved, EAGA was not felt to be an appropriate group for this. Having reviewed the existing advisory bodies, Dr Harris concluded that there was no suitable existing body and suggested a new advisory group. The new group would advise on tests for NANB Hepatitis, among other virus infections. To avoid both budgetary issues, and the need to refer the proposal to Ministers, the new group would be brought under the wing of an existing body, the Advisory Committee on the NBTS.^[25] Dr Harris included suggestions for its terms of reference and membership. He did not consider that there was a need to consult Ministers on the proposal and hoped to be able to bring the group together 'shortly'.

31.23 The EAGA's role had already become controversial. Dr McClelland observed in oral evidence that both he and Professor Cash had been members of the EAGA and made themselves 'unpopular' by exploring how other infection-related matters could be dealt with on a UK basis. This had not been acceptable to the Chairman of the group, as the EAGA's remit was intended to concentrate exclusively on AIDS.^[26]

31.24 Dr Harris's memorandum did not appear to be a reaction to Chiron's announcement. The note on NANB Hepatitis commented: 'no direct marker at present; dispute over indirect markers. No routine testing now'.^[27] Around this time people involved in blood transfusion issues were anticipating developments in NANB Hepatitis research and Chiron's announcement was known in UK transfusion circles, but it was not referred to in Dr Harris' memorandum.

31.25 In a letter dated 18 July 1988 to Dr Pickles, Dr Forrester (SHHD) welcomed the proposal to create the ACVSB.^[28] He agreed with the proposal that Dr Robert (Bob) Perry (PFC) should be a member of the new committee and proposed Professor Stan Urbaniak (SNBTS, Aberdeen) as the member for the SNBTS. That proposal appears to have been made without reference to Professor Cash or the SNBTS. Dr Forrester was happy to act as an observer.

31.26 Professor Cash also welcomed the creation of the proposed group, though it appears that he was not fully informed. In a letter dated 19 July 1988 to Dr Pickles he advised that he was pleased to learn (from Dr Pickles) that discussions were taking place which would hopefully lead to the establishment of a UK group which would concern itself with the long-term problems associated with the microbial screening of blood donations.^[29] It appears, however, that he was unaware that Dr Forrester had already made a suggestion as to who would be a suitable member from the SNBTS. Professor Cash indicated in his letter that he would appreciate the opportunity, in due course, to provide an input into the membership of the new committee.

31.27 The proposal for a new group under the aegis of the DoH did not resurface until October 1988, by which time the proposal had changed and the scope of the DoH proposals had become broader.

Formation of two advisory groups: ACVSB and ACTTD

31.28 Mr Malcolm A Harris wrote to Mr Duncan Macniven (Assistant Secretary at SHHD) on 25 October 1988.^[30] He attached a draft submission to Ministers on the setting up of the Advisory Committee on the Virological Safety of Blood (ACVSB).^[31]

31.29 By way of background, the draft commented that concern over the safety of the blood supply had been heightened by greater public and clinical awareness of the potential for viral contamination and new developments in product liability legislation. The need for a new advisory body was set out:

Decisions on testing for particular viruses involve a range of disciplines. Clinical and scientific expertise must be balanced by expertise representing the practicality and cost/benefit of testing. Neither the CSM the CBLA nor the BTS have the remit or expertise to take this broader approach. Their conflicting interests are ultimately in no-one's best interest.

The new advisory group will embrace the expertise of all interested groups ....

There is no suitable existing body. All of the UK must be covered.^[32]

31.30 The terms of reference proposed were:

To advise the Health Departments of the UK on measures to ensure the virological safety of blood, whilst maintaining adequate supplies of appropriate quality for both immediate use and for plasma processing.^[33]

31.31 Mr Harris asked for confirmation that the SHHD was content with the proposals and in particular that:

(i)the committee would operate on a UK basis;

(ii)the committee would report to the CMOs of all four health departments;

(iii)the terms of reference were acceptable;

(iv)the membership and observers arrangements were acceptable.^[34]

31.32 Mr Macniven replied by letter dated 11 November 1988 and confirmed his agreement with the proposals.^[35] He was content that the committee should operate on a UK basis and report to the Chief Medical Officers (CMOs) of all four health departments. The terms of reference were acceptable, as was its proposed membership. The proposed Scottish members remained Dr Perry and Professor (then Dr) Urbaniak. It is not known how Mr Macniven reached his views.

31.33 In the meantime, concern had been growing in the Blood Transfusion Services over the lack of progress in making provision for uniform advice on microbiological testing, as the EAGA had 'withdrawn from the field'.^[36] The issue arose at a meeting of the Directors of the SNBTS on 13 December 1988, primarily in the context of AIDS. Dr Gunson and Dr William (Bill) Wagstaff of the English NBTS were in attendance, as was Professor Cash. The minutes of the meeting noted that the DoH had indicated some nine months previously that it would take the initiative, but that this had not happened 'and meanwhile certain problems needed to be addressed'.^[37] Mr Robert (Rab) Panton (SHHD) reported that his medical colleagues would welcome the formation of a professional group. After discussion, it was agreed that the UK Blood Transfusion Services should establish a group to advise the Departments of Health on policy. Professor Cash and Dr Gunson, together with the SHHD, would put pressure on the Department of Health to bring that about.

31.34 In relation to the introduction of surrogate donation testing for NANB Hepatitis (a topic discussed more fully in Chapter 27 of this Report), the meeting agreed that the task would be dealt with by the proposed group: Scottish Directors would not commence surrogate testing until the DoH and the SHHD supported and funded it. Discussion of Chiron's test was not noted in the minutes of the meeting.^[38]

31.35 The decisions at the meeting of SNBTS Directors on 13 December 1988 had immediate impact. On 9 January 1989 Dr McIntyre wrote to Dr Pickles. He sent her an extract from the meeting, pointing out that Dr Gunson and Dr Wagstaff had been present. He expressed his concern that if the Health Departments did not establish an advisory committee, the Transfusion Services would do so. He wrote:

This method of approaching the problem we consider to be unsatisfactory and we suspect that the decisions reached might be influenced to a considerable extent by the views of the Transfusion Directors. As this is a matter which has policy implications and will be of considerable interest to Ministers we feel that this Advisory Committee should be set up jointly by the Departments.^[39]

31.36 Dr McIntyre went on to observe that in Scotland there was 'considerable pressure' from the SNBTS to fund the introduction of additional virological testing, but the SHHD was of the opinion it should be tackled on a UK-wide basis. He asked for reassurance that the Department of Health would take steps in this matter, as the SHHD 'would not like to be forced into a course of action which might have repercussions for the UK as a whole'.

31.37 The issue of the formation of the ACVSB was followed up by a letter dated 13 January 1989 from the Parliamentary Under-Secretary of State for Health, Roger Freeman, to the then Parliamentary Under-Secretary of State at the Scottish Office, Michael Forsyth, asking for Mr Forsyth's agreement to the proposal.^[40] Mr Freeman commented that it seemed timely for the Blood Transfusion Services and all other interested parties to 'act in unison on this important matter'. Mr George Tucker (Assistant Secretary, SHHD and Mr Macniven's successor) told the Inquiry in oral evidence that it was common for government officials to consult initially on a proposal or plan, before the Ministers would correspond directly and notify their agreement.^[41]

31.38 On 6 February 1989 Mr Macniven sent a memorandum to Mr Forsyth's Private Secretary to recommend that the Minister should agree to Mr Freeman's proposals.^[42]

31.39 Mr Forsyth wrote to Mr Freeman on 8 February to confirm his agreement.^[43] The Scottish members of the committee remained Professor Urbaniak and Dr Perry at this stage.

31.40 The UK Health Ministers' decision to set up the ACVSB, originally proposed the year before, was intimated in a letter of 8 March 1989 sent out by Dr Harris.^[44] Ministers believed it was 'of the utmost importance that the UK Blood Transfusion Services act in unison on this subject, and with the benefit of the best advice available'. Government policy aimed at securing common action throughout the Health Departments was established at this time.

The initial meetings of the two groups

31.41 The decision at the meeting of the SNBTS Directors on 13 December 1988 to form a UK blood transfusion services group on microbiological testing was implemented very efficiently. The resulting group, the Advisory Committee on Transfusion Transmitted Diseases (ACTTD), held its first meeting on 24 February 1989.^[45] This was about six weeks before the group established by the Departments of Health, the ACVSB, first met. Dr Gunson, in his introduction to the initial meeting of the ACTTD, was able to report that the DoH was in the process of forming another group with a brief that would be much wider than simply blood transfusion medicine. It appears to have been understood at that stage that the remit of the ACVSB would be very broad, and that the ACTTD's remit would be narrower, concentrating on transfusion-transmitted diseases.

31.42 The ACTTD had three members from Scotland: Professor Cash, Dr Ruthven Mitchell and Dr Eddie Follett, (Hepatitis Reference Laboratory, Ruchill Hospital, Glasgow) along with four English members.^[46] Dr McClelland thought members would have been invited by Dr Gunson.^[47] He added that a working group like this tended to consider where they could find the best input, rather than looking at it on a political or geographical basis.

31.43 Dr Mitchell commented in his statement that membership of the ACTTD was nominated by peer opinion and based on 'individual interest, knowledge and ability'.^[48] He was to be a member of both the ACTTD and the ACVSB, and assumed this was because he represented the largest transfusion centre in Scotland. Professor Cash confirmed in his statement he had nominated Dr Mitchell for membership of the ACTTD as he had led the SNBTS team responsible for testing kit evaluations and could be a valuable link between the ACVSB and the ACTTD.^[49]

31.44 The terms of reference adopted by the ACTTD at its first meeting were:

1. To consider the epidemiological, clinical and laboratory aspects of diseases which may be transmitted by the transfusion of blood and blood products.

2. To determine the appropriate policy which should be implemented by the UK Blood Transfusion Services for the control of transfusion-transmitted diseases.

3. To advise the Departments of Health accordingly.^[50]

31.45 Dr Gunson's introduction to the first meeting of the ACTTD on 24 February 1989^[51] recognised that the ACTTD and the ACVSB had different roles.

31.46 Dr Gunson told the meeting that Ortho had approached him with respect to conducting trials of the Chiron test in the UK. He undertook to report to the committee when further details became available.^[52]

31.47 The ACVSB held its first meeting on 4 April 1989^[53] when the committee adopted the terms of reference outlined in Mr Harris' submission to Ministers quoted above. They added a qualification, however:

Note remit is UK-wide. Our concern is matters of major policy, not the detailed implementation of policy. The intention is that any proposed changes in requirements or practices of one of the major groups (transfusion service, fractionators, regulators) that has major implications for the others are brought to this group first for discussion.^[54]

31.48 Terms of reference of related groups were noted as follows:

• the UK Advisory Committee on Transfusion Transmitted Diseases (ACTTD) would be considering many of the same issues as the ACVSB, but only from a transfusion viewpoint;
• a BTS/National Institute for Biological Standards and Control (NIBSC) group formed between the NBTS/SNBTS and the NIBSC to formulate scientific guidelines for the standardisation and safety of blood and blood products; and
• the Advisory Group on Hepatitis, which provided 'medical advice to the Chief Medical Officers of the Health Departments on all aspects of communicable hepatitis' and had the appropriate technical expertise for detailed consideration of the technical aspects of screening donors and plasma for various forms of hepatitis, leaving the ACVSB to consider the wider policy issues.^[55]

31.49 The ACVSB was chaired by Dr Harris. The initial members comprised Dr Gunson (NBTS), Dr Lane (BPL), Dr Minor (NIBSC), Dr Mortimer (PHLS), Dr Summerfield (Middlesbrough Haemophilia Centre), Dr Tuddenham (MRC) and Professor Zuckerman (Professor of Medical Microbiology). As regards the two members from Scotland, by the first meeting, on 4 April 1989, Professor Urbaniak had been replaced by Dr Mitchell, although Dr Mitchell did not in fact attend the first meeting.^[56] Dr Perry remained a member of the ACVSB from its inception.^[57] There was to be one Scottish observer from the Scottish Home and Health Department and Dr Archie McIntyre took on that role.^[58] One important consequence of the selection of Scottish members was that Professor Cash was not involved in the work of the ACVSB while Dr Gunson, his equivalent in the NBTS, was involved. Dr Perry was a member as a fractionator and not because he had expertise in the microbiological safety of blood.^[59] Members were chosen in an individual capacity, and not as representatives of their parent organisations.^[60] The omission of Professor Cash was to have consequences.

31.50 Over the period to mid-1991 which was of particular importance in the context of this chapter there were a few changes in membership of the ACVSB. Dr Jeremy Metters replaced Dr Harris as DCMO and as chairman of the committee by 3 July 1989. Professor Tedder, Middlesex Hospital, joined and attended the second meeting of the committee on 22 May 1989. Dr Tuddenham resigned before the ninth meeting on 25 February 1990 and was replaced by Dr Wensley. Dr Summerfield did not attend regularly. But otherwise the membership of the ACVSB was stable and meetings were well attended.

31.51 At the beginning of the meeting on 4 April 1989, Dr Harris made a comment that was to have important consequences for relationships between the ACVSB and the transfusion services and, in particular, the ACTTD:

He reminded members that their advice on the subjects under discussion could be publicly sensitive and should not be discussed outside the Committee, unless specifically indicated.^[61]

31.52 The minutes recorded that it was the intention that the next meeting of the committee should concentrate on viral hepatitis.^[62]

31.53 The second meeting of the ACTTD took place on 19 May 1989.^[63] From reviewing the minutes, it appears that comparatively little time was spent discussing developments in Hepatitis C screening. Dr John Barbara (NBTS, Edgware, North London) reported that ordinary donor samples saved and stored from the tri-centre trial of ALT testing (discussed in Chapter 27, Surrogate Testing of Donated Blood for non-A, non-B Hepatitis, paragraphs 27.245-27.246) were being tested with the trial Ortho anti-HCV assay at a rate of 400 per day, before proceeding with selected groups. The test was running consistently with the manufacturer's expectations. Under the heading in the minutes 'Anti-HCV testing of donations from Scotland' it was noted:

Professor Cash reported that the SNBTS would be interested in taking part in evaluative trials of the Ortho Pharmaceutical Company's Chiron test and said he would be grateful if Dr Gunson would contact him about this matter. In particular the West of Scotland centre has a bank of frozen donor samples already tested for ALT, from which further samples are available of i.v. IgG known to have produced raised ALT levels in recipients.^[64]

31.54 Dr Dow commented in oral evidence that Professor Cash, as National Medical Director, was keen to ensure that the SNBTS remained at the forefront of test developments.^[65]

31.55 The second meeting of the ACVSB on 22 May 1989 tackled the topic of hepatitis.^[66] Members advised that although colleagues in the US considered only one virus caused NANB, there may be two or more. The Chiron test was estimated to pick up only approximately 50% of cases and there was a need for caution. There had been enormous progress and once the sequence was published it would be possible to test without recourse to Chiron. In oral evidence, Dr Perry said that he was unclear what that meant other than that the release of data could pave the way for other manufacturers to come up with tests.^[67] This appears to be a plausible explanation. Dr Perry could not recall any sense in which the ACVSB was waiting for a British developed test to become available, and using that rather than relying on one that originated in the USA.^[68] However, the minute remains somewhat obscure.

31.56 The minutes noted that the DoH would keep the issue of testing under review. The use of Chiron or surrogate testing would be influenced by Chiron data once released; the Medical Research Council (MRC) might be asked to consider the data. The minute notes that members regarded the matter as a 'priority'.^[69]

31.57 The ACVSB met for the third time on 3 July 1989. Dr Metters was now its Chairman. The meeting considered the topic of non-A, non-B Hepatitis.^[70] Dr Philip Mortimer had attended a recent conference, and come away with the view that 'there was a persuasive case that the Chiron test results were reliable'. As a result the Chairman asked for all available data on NANB Hepatitis to be compiled and given to the committee for consideration at the next meeting.^[71]

31.58 In his evidence Dr Perry agreed that the impression created by the reported discussion was that there was no detectable sense of urgency in the ACVSB to introduce testing at this time, stating that:

[T]here was a greater emphasis on understanding the science than there was in saying, "We must introduce a test as soon as possible" .... There was certainly no discussion ... of a putative date at which the test could or should be introduced.^[72]

31.59 Dr Perry went on:

My general sense of the meeting was that there were some exciting international developments in relation to a specific HCV test but that it was far from clear when or if a test suitable for routine use (including confirmation) would emerge.^[73]

31.60 So far as the committee was concerned, all options were to be kept open. At this stage, that was understandable. Apprehension that the Chiron test would identify 50% of cases of virus infection in donations left 50% of cases unidentified. Depending on the outcome of early studies of the evaluation of the Ortho test in use in the UK population, ALT and anti-HBc were the only tests currently available that might provide surrogate screening in the UK donor population for agents other than HCV.

31.61 In his statement Dr Perry responded to a question whether it was a correct impression to derive from correspondence around this time that the principle of introducing a further test designed to reduce the incidence of post-transfusion hepatitis had not yet been determined. He replied:

I believe this impression is correct. It was certainly periodically emphasised by Dr Metters at ACVSB meetings that the primary purpose of the committee was to establish the policy and principle for introduction of new screening tests. At this time such a policy had neither been stated or agreed - notwithstanding the fact that many believed it to be only a matter of time.^[74]

31.62 Dr Perry added in oral testimony that he would not have considered himself, in summer 1989, to be someone who thought it was only a matter of time before testing for Hepatitis C was introduced, although he came to that view fairly soon afterwards.^[75]

31.63 When asked about Dr McIntyre's view, stated in a letter to Professor Cash on 2 August 1989,^[76] that testing would be introduced simultaneously throughout the UK, Dr Perry thought it was the 'accepted view of the committee, that this would be a UK decision and implemented in a co-ordinated manner across the UK'.^[77]

31.64 Dr Perry had no knowledge of the formal position in Scotland on the procedure for translating a 'UK decision' into local application. He added in his statement: '[R]ather it was understood that a decision by DOH (and presumably English Ministers) would be replicated in Scotland'.^[78]

Events in summer 1989

31.65 In the meantime, as the summer of 1989 progressed, several interrelated issues emerged, including collaboration between the NBTS and SNBTS at a practical level in relation to evaluation of Ortho's kit and the introduction of screening; Ortho's marketing strategies; and expectations of the role of government in the introduction of screening.

31.66 In June 1989 Professor Cash had arranged with Ortho to obtain kits for research evaluation. A preliminary report on the project, by Dr Dow, Mr A Barr and Dr Mitchell, was prepared in October 1989 and is referred to below. SNBTS had a clear and obvious interest in developing an understanding of the new test as soon as possible given the central importance of eliminating or reducing the transmission of infection by transfusion. However, Professor Cash offered a more particular explanation.

31.67 Professor Cash commented in oral evidence that the SHHD, through Dr McIntyre, had previously 'banned' Dr Mitchell's team from involvement in the testing of HIV kits as it was to be done 'centrally'.^[79] With the HCV test kits, the SNBTS was determined to have some control and to do their own test of the earliest kit they could obtain. He feared that the SHHD would defer to the DoH in London, as they had done with HIV testing.^[80] The SNBTS concern, according to Professor Cash, was the effect it would have on donor perception of the screening if there was controversy over its accuracy, especially; in the initial stages a confirmatory test was unlikely to be available.^[81]

31.68 Professor Cash was keen that the SNBTS should generate their own independent data as quickly as possible, that could be used as a 'lever' for influencing central action later on.^[82] This 'lever' was a way to get Dr Mitchell and his team involved in UK-wide testing that he envisaged would be run by the DoH.^[83] He wanted to ensure that Scotland had 'a place in the team, the UK team', that was involved in evaluation of test kits.^[84] He told the Inquiry in his statement that the SNBTS thought that engagement with Ortho might expedite outcomes from their confirmatory testing developments.^[85]

31.69 Evaluation of the Ortho kits proceeded, and information was exchanged between the NBTS and the SNBTS. Dr Gunson wrote to Professor Cash on 26 July 1989 to express his pleasure that the SNBTS was to test 5000 samples with the Ortho kit.^[86] Dr Barbara (Edgware, North London) had almost completed testing 9000 samples and the results would be sent to Professor Cash when available. The methodology adopted was explained by Dr Dow. A positive result on a first test was followed by repetition of the test, twice if the second test was negative. A sample which was positive on both the initial and one other of the two subsequent tests was classified as a 'repeat reactive'.^[87] A sample that was reactive with the first test, but negative with the two subsequent tests would be classified as an 'initial reactive'.^[88]

31.70 Dr Gunson went on to emphasise the importance of close collaboration between the SNBTS and the NBTS. He concluded by saying:

My view is that we should not move until we know what our European colleagues are doing. For the U.K. it is important that the SNBTS and the NBTS act in close collaboration since I can foresee difficulties if one of us introduced the test unilaterally.^[89]

31.71 In his reply of 28 July 1989 Professor Cash confirmed that close collaboration seemed certain, since the SNBTS would not move unilaterally unless instructed to do so by the SHHD.^[90] He commented that he had indicated to Ortho that the SNBTS would not be able to discuss contracts for supply of the test kits unless instructed to do so by the SHHD. Professor Cash agreed in oral testimony that he and Dr Gunson were planning to work together on the introduction of screening and that he was happy with that as the best course of action.^[91] Ultimately, a common start date was agreed and implemented. However, there was not a uniform pattern of concerted action between the NBTS and the SNBTS in arriving at that outcome.

31.72 Professor Cash also wrote to Dr McIntyre on 28 July 1989 to confirm the terms of a recent telephone conversation.^[92] Dr McIntyre had indicated that the decision to commence routine donation testing, using the Ortho test, would be made by the SHHD and it would not be appropriate for senior SNBTS managers to liaise directly with Ortho. Professor Cash told the Inquiry in his statement that the letter was drafted primarily to confirm and put on record important conversations he had had with Dr McIntyre, and to ensure the SNBTS directors were fully briefed on SHHD policy.^[93]

31.73 Dr McIntyre replied in a letter dated 2 August 1989. The terms and the tone of the letter are instructive:

As you are aware there is a UK Advisory Committee on the Virological Safety of Blood which is meeting regularly and considering the sensitivity and specificity of the tests available for a variety of infective agents including [the Chiron test and others]. If it is considered desirable to introduce a further routine screening test for blood donors I understand that this will be done simultaneously throughout the UK - as was done in the case of the current HIV test.

I am sending a copy of this letter to Dr Jeremy Metters, Deputy Chief Medical officer at the Department of Health and to administrative colleagues here in SHHD.^[94]

31.74 Dr McIntyre was a regular SHHD observer at ACVSB meetings, and Dr Perry thought he would have been aware of the DoH view that any new test would be introduced simultaneously throughout the UK.^[95]

31.75 Professor Cash wrote to the SNBTS directors on 3 August 1989.^[96] In his letter he advised that he believed that it was only a matter of time before screening using the Chiron test was introduced and that while he did not know when screening would commence he thought the start date would be some time after April 1990. That was much earlier than screening in fact began. Professor Cash remarked in his Inquiry statement that at the date of his letter he thought the assessment of the Ortho kit would reveal a kit with acceptable specificity and sensitivity so that screening could commence.^[97] Professor Cash's comment in his letter of 3 August that '[t]he decision to commence testing will be a UK one and will be made by the UK Departments of Health', was tempered by adding that '[t]he start date ... will, as with HIV-1, also be a matter for central government decision, with, of course, appropriate consultation with the UK BTS directors'.^[98] He concluded his letter by stating that he had 'started a battle' with Ortho on the need for confirmation testing, which he intended taking as high as he could in the Departments of Health.

31.76 Dr Mitchell's view at the time appears to have been that sensitivity and specificity of the test remained a problem that required improvement to the test to avoid the problems of false positive and negative results.^[99]

31.77 Dr Gunson wrote to his NBTS transfusion directors on 18 August 1989 and copied the letter to Professor Cash.^[100] He emphasised the need to act in a coordinated fashion, both nationally and with Scotland, with regard to the introduction of routine screening. According to Mr McIntosh in oral evidence, the regional transfusion centres in England and Wales did not report to Dr Gunson; rather, they reported to their local health authorities. In his view, Dr Gunson and his central blood authority team did not have executive authority.^[101]

31.78 Mr Tucker was an Assistant Secretary in SHHD whose role was to 'quality control check briefings and to channel advice to Ministers'.^[102] He sent a memorandum to Mr Forsyth on 23 August 1989 regarding an article on testing for Hepatitis C which appeared in The Guardian on the same day.^[103] Mr Tucker's memo confirmed that the introduction of HCV screening of blood donors was a UK issue and that the DoH would take the lead, but that SHHD and SNBTS would be represented in meetings and the appropriate Minister would be consulted before any decision was taken.

31.79 By this time there was growing concern within SNBTS that their Directors did not have sufficient information about the work of the ACVSB. The issue of the reporting of events at the ACVSB was discussed at the SNBTS Directors' meeting on 29 September 1989.^[104] By then, it was reported on behalf of Mr Panton that there had been progress. It would be in order for Dr Perry and Dr Mitchell, as members of the ACVSB, to report the Committee's discussions and recommendations to the other SNBTS Directors. Miss Corrie, the minute taker, was to seek written confirmation of this from Mr Panton, and to ask if the Directors could have copies of the ACVSB minutes.

31.80 At the SNBTS Directors meeting of 13 February 1990 it was noted that 'it would be in order for Dr Perry and Dr Mitchell to report the discussions and findings of the Committee to fellow Directors, but ... the minutes could not be copied to them'.^[105] The minutes could, however, be passed around and discussed at the Directors' meetings informally. The same position was said to apply in the NBTS. Thus the provision for relaxation of confidentiality noted by Dr Harris at the first meeting of the ACVSB was given practical effect.

Medical literature on testing in summer 1989

31.81 Before returning to events in the UK, it is appropriate to note what was happening in the wider scientific community, as a great deal of research was being published at the time. As noted above,^[106] Science published an article by Kuo and others on 21 April 1989 giving scientific information on the Chiron discovery and the research behind it.^[107] A radio-immuno assay was used in the research phase leading to the announcement of the discovery. A radio-immuno assay utilises radioactive material and the research team was encouraged, according to Dr Dow, to discontinue use of that technology, and to develop an ELISA rather than expose workers in general laboratories to radioactivity. The researchers had also moved on from the initial clone and had found a slightly longer strip of the NANB Hepatitis virus genome.^[108] The ELISA assay performed well using 'well pedigreed' NANB Hepatitis samples,^[109] showing high levels of reaction in those samples when compared with reactions to alcoholic and other forms of non-viral hepatitis. The ELISA tested for C100 antibodies, a late-appearing antibody in terms of the period lapsed since infection. Researchers noted later that antibodies in drug addicts in the acute early stage of NANB Hepatitis were not detected by this test. The second generation tests developed later were able to detect earlier appearing antibodies, thus shrinking the 'window period' of infectivity.^[110]

31.82 With regard to the Science article, Dr McClelland commented in oral evidence that it would have been difficult to be confident about any estimate of the sensitivity of the assay when it was completely new. There was no reliable, independently certified set of known positives to use as controls. Furthermore, any new technique used by the research laboratory that developed it would work better than in the field: the research scientists would know its 'little ins and outs' and 'technical foibles'. They would almost always produce better results in the early days than would be produced by people from other laboratories.^[111]

31.83 The Lancet of 5 August 1989 contained an editorial concerning the Ortho test entitled 'Will the real hepatitis C stand up?'.^[112] The editorial concluded: 'It would be logical to confer the title of hepatitis C on the newcomer'.^[113] The issue also included a series of results of the new test system from Spain and Holland and two from Germany.^[114]

31.84 The editorial noted:

In general, the results support the sensitivity and specificity of the test system, and underline both the urgency of making the test system available for blood donor screening, and the importance of despositing [sic] the sequence of the viral genome in the GenBank database where it would be available to the wider scientific community.^[115]

31.85 The research reported from Spain was focused on prevalence in patients at high risk of infection.^[116] Dr Dow was referred to Table I in the paper and was impressed with the figures for positive tests, as the percentage figures were as high as he would expect from high-risk groups.^[117] The test at this stage appeared to have good sensitivity in high-risk groups where the virus would be expected.^[118] The figure of 64% for positive reactions in a group of people with haemophilia was very close to the finding of anti-HCV positivity in patients with haemophilia in the (subsequent) Scottish paper.^[119]

31.86 The authors stated that:

Our results show that HCV accounts for most cases of post-transfusion hepatitis in Spain. Although seroconversion may occur during the acute phase of the infection (in about a third of cases), in more than half of our patients, anti-HCV antibodies were first detected 4-6 months after transfusion, and in some the antibody response was considerably later.^[120]

31.87 According to Dr Dow, the authors referred here to a time delay following infection and before the RIA would pick up the HCV antibodies.^[121] The authors themselves commented: 'This delayed response could explain why anti-HCV was not detected in all our post-transfusion cases'.^[122]

31.88 The Dutch study in The Lancet^[123] was a prospective study of patients undergoing heart surgery. Post Transfusion-NANB Hepatitis (PT-NANB Hepatitis) developed in nine patients, and four of those seroconverted. The authors commented:

We have shown that in a Dutch blood donor population the new anti-HCV RIA developed by Chiron specifically identifies blood products associated with NANB hepatitis in patients who have received transfusions .... Sensitivity of the assay for detecting probable NANB infected blood products was 67% in our study population.^[124]

31.89 The patients studied were in a group of people assumed to have a low incidence of HCV. The number of cases of PT-NANB Hepatitis was small. The authors concluded:

Despite its limited sensitivity, the high specificity of this first generation anti-HCV assay should permit greatly improved donor screening procedures for the prevention of PTH-NANB.^[125]

31.90 The German research published in the same issue of The Lancet^[126] related to a study of donors at four German blood banks using the Ortho ELISA. By categorising donors in different ways the researchers found that samples from certain groups were repeatedly reactive. They observed, however, that in the absence of a confirmatory test, the true frequency of HCV infection in their population remained to be determined. A note of caution was sounded regarding confirmatory testing:

The use of the same recombinant antigen material - ie, that constituting the solid material in the EIA - for a confirmatory test (eg, immunoblot) would not be satisfactory scientifically.^[127]

31.91 The same edition of The Lancet contained a second letter from researchers in Germany.^[128] This study looked at patients rather than donors, using the Ortho ELISA tests. Researchers looked at patients with acute and chronic NANB Hepatitis and at high-risk patients - haemophilia patients, patients on haemodialysis and drug addicts. They reported:

Seroconversion seems to occur late after onset of disease since acute post-transfusion NANBH patients have a lower prevalence of anti-HCV than chronic cases, and seroconversion occurred at 3-4 months post exposure in 3 patients with haemophilia. The low prevalence of anti-HCV in haemodialysis patients in our study may reflect a selected population.^[129]

31.92 On 26 August 1989 The Lancet published a letter written by Drs Contreras and Barbara from the North London BTC on the subject of 'Screening for hepatitis C antibody'.^[130] The authors agreed that the Chiron/Ortho ELISA for anti-HCV was specific for the major agent causing post-transfusion NANB Hepatitis and was superior to all previous attempts at a test for the NANB virus. However, they struck a note of caution with regard to the screening of donors for anti-HCV:

As in any other assay, the predictive value of a positive result hinges on the prevalence of the marker in a given population. While the test scores well in panels of well-characterised NANB hepatitis sera and in samples from patients with a diagnosis of NANB hepatitis, we do not know the predictive value of the test in low prevalence populations, such as UK blood donors.^[131]

31.93 The authors went on to emphasise the importance of a confirmatory test to eliminate uncertain results, before realistic policies for generalised screening of blood donations could be implemented.

31.94 In addition, the 26 August 1989 edition of The Lancet contained a letter by Professor Cash and Drs McClelland, Urbaniak, Brookes and Follett on the subject of screening for Hepatitis C.^[132] They also emphasised the importance of a confirmatory test. Without such a reliable test there would be serious problems for blood transfusion services, which would probably be required to absorb the majority of counselling of sensitive donors. A repeatedly reactive ELISA test was 'suggestive but not definitive' evidence of the presence of HCV antibody. A confirmatory test which used the same antigen as the ELISA test was described as 'scientifically less than satisfactory' but 'better than nothing'. The authors urged Ortho to make available reagents and/or tests that would ensure that an assay system that was fundamentally different from the marketed ELISA test could be used for confirmatory testing.

Supplementary and confirmatory tests

31.95 As was implicit in the letter by Professor Cash and others, a 'confirmatory' test was ideally a test that was fundamentally different from the ELISA currently on the market, that would affirm the initial screening test, or not, and provide a reliable basis for diagnosis and counselling. Dr Dow commented that, in general terms, a confirmatory test would be better than a supplementary test.^[133] Dr McClelland observed in oral testimony that the terms were very difficult to define because 'there are numerous definitions invented by various people'.^[134] In his view, a confirmatory test should assist in deciding if a positive screening test result is a real or a false positive result. The type of test used for confirmation did not matter provided it could determine if an earlier test was truly positive. A 'supplementary' test, that simply repeated the initial screening test, was much less useful.^[135]

31.96 Professor Leikola observed in oral testimony:

[T]hat a true confirmatory test should be based on the principle that it is different from the original antibody/antigen reaction, in order to show from another point of view that it really is a true reaction between the virus and the antibody.^[136]

31.97 The difficulty in the early days of anti-HCV testing was that there was only one antigen because only a small section of the virus had been isolated. As a result only one antibody was identified by the screening test, whether on initial or repeat testing. The recombinant immunoblot assay (RIBA) that Ortho developed later as a confirmatory test targeted the same antigen. For a test to be truly confirmatory it would be required to detect an antibody to some other part of the virus, or the virus itself. Because the RIBA looked for the same protein, it could only have been a 'supplementary' test and not 'confirmatory' of the initial screen result. By way of contrast, in later developments virus laboratories would test for the virus itself using a Polymerase Chain Reaction (PCR) test which was truly confirmatory because it is based on a different principle from the initial screening tests.^[137]

The position in Finland in 1989-90

31.98 Professor Juhani Leikola assisted the Inquiry as expert witness and spoke to events in Finland, which provide a useful comparison to events in Scotland and in the UK as a whole. His general evidence had a basis in the work of the Finnish Red Cross. There were structural differences between the blood transfusion services in Finland and in the UK which have to be taken into account, but these do not invalidate the comparison. Finland is a small country, where the prevalence of NANB Hepatitis was very low, at less than one per cent. By the end of 1989, it was known to the UK Blood Transfusion Services, including the SNBTS Directors, that the Finnish Red Cross had arranged with Chiron to test samples at the same time as evaluation was proceeding in the United Kingdom.^[138]

31.99 Professor Leikola was approached by Ortho in the spring of 1989 and asked to arrange a study of their new test kit, together with researchers from Sweden and Denmark.^[139] There was considerable contact between these countries in the blood transfusion field, although the organisation of their individual transfusion systems was different. Sweden and Denmark had independent hospital blood banks within hospital authorities, while in Finland the Finnish Red Cross organised a blood transfusion service on a countrywide scale.^[140]

31.100 In evaluating the Ortho assay, Finnish researchers looked at both material from a large prospective study done by Dr Freja Ebeling between 1987 and 1989 and local haemophilia patients.^[141] Dr Ebeling's material was from a post-transfusion (PT) hepatitis study of 685 patients who had undergone open heart surgery. Hepatitis was diagnosed when the patient's ALT was found to exceed 2.5 times the upper normal value in one sample and 2 times the upper normal value in a second sample, and where non-viral causes could reasonably be excluded. Of the 685 coronary bypass patients, 11 developed elevated ALT levels during the six post-operative months, and were diagnosed as having acute NANB hepatitis by exclusion of non-viral causes, an incidence of infection of 1.6%. This research was subsequently written up in November 1990 in an article in Transfusion Medicine.^[142] A secondary object of the exercise had been to obtain samples for future evaluation of possible preventive strategies, and the material was available when Ortho provided kits for evaluation in the course of the project.

31.101 Dr Ebeling's research group applied the Ortho ELISA and a Chiron RIBA 'confirmatory' research test to the panel of 685 frozen samples already collected. Samples from the 11 patients diagnosed with post-transfusion, NANB Hepatitis were tested. Seven of them had received a blood product from an anti-HCV positive donor, on the ELISA test. A further 1029 donor samples not associated with a PT Hepatitis case in the earlier phase of the project were tested and six of these were found to be anti-HCV positive on the ELISA test. The six samples were all associated with hepatitis (raised ALT) in a patient recipient, and five of these were shown to have seroconverted (developed HCV antibodies), based on the ELISA test.

31.102 The group published the preliminary results of this research in a letter to The Lancet on 21 April 1990.^[143] The letter referred to the earlier The Lancet publication by Dutch researchers^[144] and agreed with their findings that it was possible that false-positive results would be achieved with the ELISA test when screening low prevalence groups such as blood donors. In false positive cases, the kit had failed to differentiate between non-infectious and infectious blood, which would make it difficult for blood transfusion centres to decide which blood units to discard and which donors to counsel.

31.103 On the basis of this research, however, the scientists suggested the RIBA might be helpful in differentiating between an infective and a non-infective blood donor, and that reactivity to both antigens (511 and C100) was strongly associated with infectivity.^[145]

31.104 Professor Leikola said that the Finnish researchers were very keen to try the new Ortho kits on the 11 patients identified in the first phase of the project as having NANB Hepatitis. Of the five who had been found to be anti-HCV negative, two had an anti-HCV positive donor. Professor Leikola commented that this demonstrated the initial (ELISA) test was not highly sensitive, and those two patients might have been positive with use of the test kits developed later.^[146] He also observed that the level of HCV antibody fluctuated in patients. Sometimes the level was below the cut-off level for positivity and these patients were considered to be HCV negative due to that fluctuation.^[147]

31.105 Despite Finland having a very low prevalence of NANB Hepatitis the development of the Ortho test was welcomed there as NANB Hepatitis was still the most common infectious complication of blood transfusion. The new screening test to detect antibodies offered major advantages.^[148]

31.106 Professor Leikola also provided the Inquiry with a translation of a memorandum he wrote in Finnish dated 10 October 1989.^[149] It was intended for internal discussions and for the Finnish National Board of Health, which was responsible for the practical aspects of healthcare.^[150] He commented in his memorandum: 'Thus, HCV is not responsible for all NANB hepatitis cases, and not all anti-HCV positive persons transmit this disease, but the association of HCV with NANB hepatitis is clear in Finland.'^[151]

31.107 The overall prevalence of HCV positivity in Finland was considered to be 0.73%. Professor Leikola commented in his memorandum that this was 'possibly slightly higher than in the rest of Scandinavia, which number is somewhat surprising considering the clinical background'.^[152]

31.108 The Finnish Red Cross did not require the permission of the National Board of Health to introduce screening, but did need their consent to increase the price of blood products to reflect the increased screening costs.^[153] This proved to be a straightforward matter and consent was given by the Director General of the National Board of Health at a meeting in December 1989. The request did not have to go to a committee and permission was granted at a single meeting, in stark contrast to the situation that evolved later in the UK.^[154]

31.109 In the conclusion to the memorandum, Professor Leikola stated his concern at the lack of a confirmatory test, but added:

The repeatability of the screening test is, however, good. The FDA may register the test ... before the end of this year, and the American blood services will start using it as soon as possible. Testing may start soon next year also in Europe, wherever it is technically possible.^[155]

31.110 In his memorandum, Professor Leikola commented that whilst most hepatitis cases remained mild, they had a tendency to become chronic, and therefore, 'Since a specific test now exists that may reduce the blood inventory by as little as less than one per cent, a general screening test has to be introduced in our country to safeguard ... transfusion safety'.^[156]

31.111 The memorandum, from October 1989, discussed the possibility of commencing screening in Finland in the first quarter of 1990. In practical terms, the introduction of screening was relatively straightforward for Finland as there was only one, central, laboratory in the capital, Helsinki, and donations collected by mobile teams were taken there. The introduction of screening would have affected the working of only one laboratory service and would have been much simpler than having various different centres, each with its own laboratory. It would have to be a staggered start due to a limited number of testing kits and the pressures on the laboratory. The Finnish populations with higher prevalence would be screened first. 'A similar approach was used with anti-HIV screening which was started ... [in] Helsinki area donors.'^[157] The memorandum concluded: 'Despite the costs and other difficulties anti-HCV screening has to be started at the [Finnish Red Cross] Blood Service as soon as it is technically possible.'^[158]

31.112 In oral evidence, Professor Leikola said that it was not controversial to introduce screening in a staggered fashion across the country. They had used that pattern for the introduction of anti-HIV testing, and followed the same pattern with HCV without any obvious objections.^[159]

31.113 Routine testing duly commenced in Finland in the beginning of February 1990 and was extended to all blood donations by 1 April of that year.^[160]

31.114 Dr Ebeling and colleagues proceeded to study a group of haemophilia patients in Finland.^[161] Finland was self-sufficient in the production of clotting factors. Until 1984, small pool lyophilized cryoprecipitate (manufactured from two to eight donors) was used exclusively to treat Haemophilia A, von Willebrand's disease and Factor VIII deficiency. The total population with bleeding disorders on the central register was 230 patients. Samples were received from 137 patients, all but ten of whom had haemophilia. Surrogate tests were performed and the patients were tested with the Ortho kits. Of the study group, 68 patients (50%) from a total of 137 were anti-HCV positive, with most of the samples demonstrating strong reactivity. There was a significant association of anti-HCV with raised levels of ALT in the blood.

31.115 The research paper on this study noted that patients with severe haemophilia had Hepatitis C antibodies significantly more often than those with milder forms of haemophilia. In addition, anti-HCV positivity was significantly more common in AHF-20 (large pool concentrate) users than in cryoprecipitate users.^[162]

31.116 It was noted that HCV antibodies sometimes seemed to disappear and that the percentages brought out might underestimate the number of patients with a previous HCV contact. On the other hand, the results might have been skewed in the opposite direction since patients who already knew that they had liver disease might be more willing to participate in the study.^[163] Chiron's new RIBA confirmatory test was available to test some of the anti-HCV ELISA positive samples and proved to be very specific. It was concluded that 'false positive results were only a minor source of error among these patients'.^[164]

31.117 Professor Leikola was asked in oral evidence if the difficulties faced by transfusion services in dealing with 'false positives' could justify delaying the introduction of a screening test. He commented:

[I]t was very clear that as long as the number of positives ... including false positives in the primary screening is low enough so we can handle figures that are less than one per cent, and explain to the donors what is the situation ... in our opinion at the time it would not prevent introducing such a test.^[165]

Initial evaluation in England

31.118 Returning to events in the UK, as noted above at paragraph 31.69 evaluation of Ortho's assay proceeded in the United Kingdom in 1989. A preliminary report of the NBTS pilot study of the first generation Ortho test, dated 23 June 1989, was presented to the third meeting of the ACVSB, on 3 July 1989. It gave summary results of tests of 3282 donations and noted that there were 22 initial reactive samples and 14 repeat reactive samples.^[166] The report was brief and provides little useful information for present purposes.

31.119 A second report of the pilot study, dated 10 January 1990 but relating to work undertaken in early December 1989, was presented by Dr Gunson to the fifth meeting of the ACVSB on 17 January 1990. A total of 14,133 donations had been tested by North East Thames, Trent and West Midlands RTCs.^[167] This report assessed the practical implications of introducing the Ortho ELISA test. All participants commented that 'the test was straightforward and easy to perform'.^[168] However difficulties with equipment and software, process problems and the marked difference in positivity rates returned, made it difficult at that stage to estimate the costs involved in screening.^[169]

31.120 A full report on the evaluation of the Ortho HCV ELISA test system was included in the Report on the 'Multi-Centre UK NANBH Surrogate Marker Study' dated April 1990.^[170] The report noted that Dr Gunson had arranged a supply of test kits from Ortho sufficient to enable testing of the sera already available from the surrogate marker study.^[171] In total 9741 samples were tested: more than 3000 at each of three centres (North London, Bristol and Manchester).^[172] The methodology was described: 'all initially reactive sera were retested in duplicate'.^[173] Testing was completed by early October 1989. The study found a geographical variation in the prevalence of HCV seropositivity, ranging from 1:277 for Bristol (described as 'a rural base') to 1:120 for North London (a 'metropolitan area'). There was a correlation between raised ALT and HCV seropositivity.

31.121 The report noted:

Although from the results obtained so far it appears that the Ortho HCV ELISA has an acceptable specificity and sensitivity, these issues can not be definitively addressed as part of this evaluation, as there were no samples with well established links with NANBH tested in this study. However, this first report on screening UK donors sera for anti-HCV will serve as a basis for the future implementation of this screening test in the UK Blood Transfusion Service.^[174]

Initial evaluation by Dr Dow and others in Scotland

31.122 Work proceeded on a Scottish evaluation of the Ortho assay. A preliminary report of the study was dated 5 October 1989.^[175] The study was instigated by Professor Cash, following up his statement of interest in evaluating the anti-HCV test made at the meeting of the ACTTD on 19 May 1989. Dr Dow was a member of the team that carried out the study. He agreed that it was an ambitious study, with nine objectives.^[176] Professor Cash had arranged to obtain the kits in June 1989. The regions each submitted samples by the start of August and testing commenced on 2 August.^[177]

31.123 This study had a repeat reactive rate of 0.47% overall (13/2745). There were variations within Scotland, with Aberdeen having a rate of 0.35%, Dundee a rate of 0.49%, and Glasgow a rate of 0.55%.^[178] Dr Dow thought that the overall figure was comparable to the German figures, and considerably lower than the rate the English study found in North London.^[179]

31.124 Of the group of 15 patients reported to have developed post-transfusion NANB Hepatitis, Dr Dow's team found only a third (five) of the group to be anti-HCV positive.^[180] The limited positivity in this group of 15 people was due, according to Dr Dow, to their having been tested early in their illness. It became known later that the first generation tests were not sensitive enough to pick up HCV in its early stages. They would also have failed to pick up some of the HCV genotypes that were discovered later, for example those that did not have the NS4 protein that was detected by the early Chiron test.^[181]

31.125 Professor Leikola's attention was drawn to this finding of the study and he agreed it was a disappointing result. He told the Inquiry that this could have been due to the way in which cases of NANB Hepatitis were identified. Further, some of the patients from the group of 15 may have had antibodies that disappeared from their blood over a prolonged period of time. He agreed also that a late appearing antibody would have been difficult to pick up if the samples had been taken early on in the progression of the disease, but he did not think that blood samples that had been frozen would yield unreliable results. In relation to patients with haemophilia, the Scottish study obtained results that can be compared with the Finnish work. Of 146 patients with haemophilia in the West of Scotland, 92 (63%) were repeatedly reactive for anti-HCV).^[182] Dr Ebeling found 68 of 137 haemophilia patients (50%) to be anti-HCV positive: paragraph 31.114.

31.126 Dr Dow's study also looked at sera from donors implicated in 28 cases of transmission of non-A non-B Hepatitis. This revealed only six donors as repeatedly reactive for anti-HCV. On that basis it appeared that only 21% of cases of post-transfusion NANB Hepatitis had a donor identifiable as being anti-HCV reactive. The report commented on theoretically possible explanations: individuals could lose antibody over time at one end of the scale, or at the other may not have developed anti-HCV by the time the sample was taken.^[183]

31.127 The authors were disappointed that their study suggested that the Ortho test would have prevented only 21% of the PT-NANB Hepatitis cases. The report suggested this might be due to some cases being caused by another agent, a possible early suspicion of what came to be known of the different genotypes in existence.^[184]

31.128 Overall the report authors found that 'the Ortho HCV ELISA test has been shown to have an acceptable specificity'.^[185] The fact that the test took three hours to complete did not present difficulties to the team testing samples in Dr Dow's laboratory.^[186]

31.129 The report had noted as 'worrying' an apparent diminution in the sensitivity of the HCV test kit as compared with the 'Dev' kit. Dr Dow offered an explanation for the difference between the kits at paragraph 8 of his statement:

The test kits used in the SNBTS evaluation comprised two lot numbers, DEV89038 and HCV101. The DEV kit was probably meant to be a Developmental kit (produced in smaller volumes) whilst HCV101 would have been one of the first production lot numbers.^[187]

31.130 In oral evidence Dr Dow added: 'This was one of the first times we had seen a development kit being used to do an evaluation ... we [SNBTS] had actually requested a kit to evaluate it on our own behalf, rather than the company's behalf'.^[188] He explained that with a 'dev' kit the manufacturer can still make changes, which cannot subsequently be done with a 'production batch'.^[189]

31.131 This was the first time the SNBTS had had access to a test for HCV. In his evidence to the Inquiry Dr Perry said that he thought it would have been too soon for this evaluation in Scotland to form the basis of a decision to use the Ortho test. It would have been seen as a Scottish contribution to a UK wide body of knowledge and would have been likely to have gone to the ACTTD for discussion.^[190] He expected the SNBTS to be informed in their decision making by 'wider UK and international experience of its suitability'.^[191] The international experience was important in studying places or populations where the test was not effective. If there had been an 'international experience where there were significant issues and problems, then clearly that would have affected our [SNBTS] decision to introduce'.^[192]

31.132 Professor Leikola commented in his statement that in a low prevalence country such as the UK, a very large study is required to produce a meaningful number of positive samples to test. He added in oral evidence that 'we [Finland] had to test 15,000 blood donors that were connected with the patients, and that only gave 11 cases and six of them were positive'.^[193]

31.133 Professor Leikola wrote a review article published in 1993 entitled 'Viral Risks of Blood Transfusion'.^[194] He commented on the identification and isolation of the first clone and the study in 1989 of the first generation assay by Harvey Alter and colleagues. The assay was reported in that study to look very promising for the diagnosis and prevention of NANB Hepatitis. The test gave positive results in a high percentage of US patients with NANB Hepatitis. European experience was less promising. There were reservations about the test. The review commented:

In subsequent studies from Europe, the percentage was, however, lower. The test was sufficiently specific to study high prevalence populations such as hepatitis patients but it gave many false positive results when applied in blood donor screening. There was no true confirmatory test since everything was dependent on only one recombinant antigen.^[195]

Encouragement from Ortho to conclude contracts

31.134 Dr Gunson had indicated in his letter to Professor Cash dated 26 July 1989 that Ortho representatives were keen that he should be in contract with them for test kits.^[196]

31.135 On 23 August 1989 representatives of Ortho attended a meeting in London with members of both the NBTS and the SNBTS.^[197] Dr Mitchell attended and provided a report for Professor Cash two days later.^[198] Johnson & Johnson (Ortho) had recently released material to Abbott Laboratories under licence. In addition to a royalty, the agreement ensured that Abbott would not develop any form of test similar to Ortho's test. The letter disclosed that steps had been taken to ensure that Abbott would be at least a year behind in making a distinctive test available. Abbott would not have clinical trials done before the second half of 1990. The agreement was intended to ensure that there was no competition while Ortho built up a market share. Dr Mitchell recalled in his statement that the meeting with Ortho revealed a need to improve the company's first generation test, but Ortho was still very keen to have it introduced in the UK before it was licensed for use in its country of origin.^[199]

31.136 The doctors in attendance were offered kits at 1989 prices if a decision to purchase was made before the end of that year. The costs of ordering kits at 1990 prices would be higher. Ortho also offered packages combining kit sales and the provision of Ortho technology. However, Dr Mitchell advised that alternatives to the early purchase options did not have the same impact since they were purely hypothetical in terms of the next one or two years.^[200]

31.137 The Ortho representative was keen to know if, and how, a decision on HCV testing would be made. He was told it was subject to the advice of the ACVSB, and could not possibly be made before their meeting on 17 October 1989. In addition, it would take time for screening to be introduced as a number of other associated matters would have to be organised first, such as counselling of donors, staffing and finances. It was made clear to Ortho that if a decision to introduce screening was made, 'the UK would move in unity and that there would be a simultaneous announcement, as happened with the HIV antibody testing'.^[201] Dr Mitchell told Ortho there was 'little likelihood that the Scottish Transfusion directors would wish to have any kits ... until a decision was made'.^[202]

31.138 Dr Mitchell's letter of 25 August 1989 to Professor Cash ended:

I wish to stress that no decision was made that no (sic) Department of Health was committed to any decision in advance of the recommendations of the Advisory Committee which will make its own decision following the Rome meeting and taking account of all the scientific evidence which is being made available.^[203]

31.139 In the domestic Scottish context, Professor Cash was again being reminded that policy was a matter for the ACVSB.

Scientific meetings in autumn 1989

31.140 The Rome symposium organised by Ortho on 14-15 September 1989 provided a new focus for consideration of the Ortho ELISA. Dr Mitchell and Dr Gunson attended the symposium. Each produced reports intended in the first instance for the ACTTD meeting due to be held on 9 October that year.^[204]

31.141 Dr Mitchell commented in his Inquiry statement that the symposium was an important meeting. There was optimism that sufficient alterations would be made to the test to make it suitable for widespread introduction.^[205] However, his view of the test as reflected in his report was less than enthusiastic. He emphasised the lack of a confirmatory test and the need, so long as that remained the position, for some form or set of control samples to be issued with the test to ensure that sensitivity was maintained. His view was that results should be repeated on a number of occasions at subsequent donor attendances before donors were counselled or notified. He noted that some of the issues with the test were 'obvious in the data collected from the Scottish survey'.^[206]

31.142 Dr Gunson's first report of the Rome meeting also commented on the lack of a confirmatory test and emphasised that such a test for seropositive blood donors was urgently needed.^[207] Chiron's proposed RIBA test had limitations but would resolve some false results. The ACTTD was asked to approve in principle the routine testing of blood donations for anti-HCV and to request the National Directors in England and Scotland to arrange for the simultaneous introduction of the tests at an appropriate time when a policy had been defined for handling the seropositive donors.^[208]

31.143 In the interval between the Rome meeting and 9 October, the British Blood Transfusion Society met in Durham. On the last day of the meeting (around 22 September) doctors from the NBTS and the SNBTS^[209] met with Ortho representatives. Dr Mitchell produced a note of the meeting.^[210] He reported that Dr Gunson had indicated that, in his view, it was likely that the ACTTD would recommend to the ACVSB on 6 November that screening should be introduced in the 1990/91 financial year, and thus would commence some time after 1 April 1990. It was anticipated that the meeting of the ACTTD on 9 October would finalise the details of the report or reports to the ACVSB. Ortho had indicated that a lead-in time of at least 90 days would be required but, given that period, Ortho could supply kits on a regular basis and have at least two different batches in centres at any one time. Dr Mitchell recorded that Dr Contreras was hesitant at the speed of introduction proposed, especially since no account had been taken of how donor counselling would be carried out. She considered that some of the data presented at Rome and elsewhere were imprecise and that there were many grey areas. Nevertheless, there was recognition that the implementation of the European Commission requirements for blood and blood products was imminent (in 1992) and that member state governments might have to 'subscribe to ... ''State of the Art'' technology'.^[211] By this stage (October 1989) the Chiron/Ortho test was being used in a large number of blood transfusion laboratories, as well as many virology diagnostic laboratories, throughout the world, albeit no country had yet introduced the test for routine screening of blood donors.

31.144 The ACTTD duly met on 9 October 1989, its third meeting.^[212] Members were told that the ACVSB had requested a briefing paper on policy regarding anti-HCV testing of blood donors. The committee considered the two papers, written by Drs Gunson and Mitchell. In addition, a report from North West Thames RTC on surrogate markers for NANB post-transfusion hepatitis was discussed. It was agreed Dr Gunson's paper should be amended for presentation to the ACVSB, to incorporate information from the paper prepared by Dr Mitchell, and the North West Thames report, and to reflect a number of textual amendments proposed by the committee.

31.145 Dr Gunson duly amended his report for presentation to the ACVSB.^[213] The main recommendation in Dr Gunson's amended report was that: 'Routine screening of blood donations for anti-HCV should be introduced when practical .... The committee [ACVSB] is asked to approve the routine testing of blood donations for anti-HCV in principle'. The recommendation was subject to the following conditions:

• There should be a defined policy for counselling and management of seropositive donors.
• A confirmatory test for seropositive blood donors was urgently needed. The RIBA put forward by Chiron had limitations.
• The routine use of the test should not commence until an FDA licence was in place.
• Pilot studies involving routine prospective use of the test in RTCs on freshly collected samples (as opposed to library frozen/thawed samples) should be established as soon as possible.

31.146 The fourth meeting of the ACVSB took place on 6 November 1989.^[214] Dr Gunson spoke to his paper and told the committee that the ACTTD recommended that routine screening should be introduced only after a confirmatory test became available, after the FDA had approved the test and after urgent pilot studies had been carried out in this country to consider the feasibility of using the kits on freshly collected samples and to assess how they could be integrated into normal working practices.^[215] The ACTTD considered that routine testing for anti-HCV would reduce the incidence of NANB Hepatitis. Estimates of the extent of the reduction ranged from 20-60%.

31.147 The Chairman, Dr Metters, summed up the views of the ACVSB. They broadly took on board the recommendations of the ACTTD, but stopped short of approving the introduction of routine testing in principle. The feeling of the committee was that while the test represented a major step forward, the committee needed to know a great deal more about it, and there was a need for a confirmatory test. The ACVSB would support the general introduction of the test if the FDA approved it and the pilot trials showed the test to be feasible and non-problematic. Pilot studies would be carried out in Brentwood, Birmingham and Sheffield, of the feasibility of adding the kits to routine practice.^[216]

31.148 Dr Perry (who had not attended the meeting) commented in his Inquiry statement that, upon reading the documents, he thought Dr Gunson was trying to convey to the ACVSB the views of Transfusion Directors that the implementation of testing was inevitable. Dr Gunson was recommending to the ACTTD that the test was effective and should be taken seriously and ultimately introduced.^[217] The minutes of the ACVSB recorded 'a much more cautious position'.^[218] According to Dr Perry this may have been due to the views of influential members such as Professor Zuckerman, Professor Tedder and Dr Metters.^[219] He recalled that the ACVSB Chairman, and some of the expert Virologists, considered Dr Gunson's approach to be 'premature'.^[220]

31.149 In his written statement Professor Leikola commented that he thought the outcome of the meeting of the ACVSB noted above was 'quite reasonable'.^[221] In oral evidence, he qualified that statement. He said that he was a little surprised to see no clear cut decision to implement screening of donors. There was a recommendation of sorts and it was considered useful to have the test. But he explained that at this stage the FDA had not even licensed it for export, and therefore everything was on a preliminary and research level. It was 'sort of natural that the committee was in general ... in a positive mood towards a future screening by this test but decided then to wait and see the developments and make a definitive decision later on'.^[222] The minutes were not clear as to the committee's commitment, but he understood the minutes to indicate that once FDA approval was given, and there was a confirmatory test, the decision would be positive if there were not any major problems.^[223] On his understanding of the decision, that there were these automatic triggers, he thought the outcome of the meeting was reasonable.^[224]

31.150 Dr Gunson reported the cautious views of the ACVSB to the next meeting of the ACTTD on 22 November 1989.^[225] Dr Perry commented in oral evidence that 'it was probably an outcome that was predicted ... everyone knew at that point that the UK was not ready to implement HCV testing'.^[226]

31.151 It appeared to Dr Perry that it was typical of the cautious approach of a government department not to make a policy decision until it was proved to be deliverable and all its consequences were known.^[227] He thought the policy makers in the government were naturally more cautious than the practitioners who delivered the services would have wanted. In his view, that conflict would always be present.^[228] Professor Leikola appeared to be in agreement with this view in his initial statement to the Inquiry on this topic. In relation to this period, Professor Leikola observed that opinion was divided between the views of the practical transfusionists and the academics.^[229] He thought that Dr Gunson was a practical transfusionist.^[230]

Export permit and 'confirmatory test' in November 1989

31.152 As appears from the discussion so far, one of the factors which featured in discussions of the possible introduction of screening in the UK over the period 1989 to 1990 was whether the FDA in the USA would approve the test for use there. In his statement Dr Perry expressed the view that waiting for the FDA to license the test kit was intended to provide the UK with evidence of satisfactory performance in the absence of a formal UK evaluation. There was no similar licensing regime in Britain. It would have been embarrassing if the test had been introduced in the UK and the FDA then refused to license it for use within the USA. He thought Ortho was unlikely to have retained their earlier export licence if the FDA had rejected the application to 'license' it in the USA.^[231] In his statement, Dr Dow commented that:

The FDA were notoriously strict controllers of the quality of test kit systems. To be informed that a kit was FDA-approved meant that the manufacturers were expected to keep the same sensitivity and specificity over all lots that were produced, thus ensuring that the kits were robust quality products.^[232]

31.153 By way of contrast, a different, more casual, attitude to FDA licensing was reflected in a Department of Health memorandum dated 30 January 1985 relating to the introduction of screening for HIV.^[233] The memorandum, entitled: 'Evaluation of HTLV III kits: Some thoughts for consideration', noted that 'USA firms will have obtained some sort of FDA clearance before marketing in the UK starts'.^[234] A different DoH memorandum dated 21 January 1985 stated: 'We also discussed whether or not any reference should be made to tests not being accepted in the UK unless they had FDA approval ... FDA approval was in any case one of the factors to be considered in any evaluation'.^[235] Dr Dow's view is preferred: as a scientist with practical experience of the way the system operated, he had direct knowledge of the working of the FDA. The reference to 'some sort of FDA clearance' indicates a lack of understanding on the part of the official.^[236]

31.154 Ortho Diagnostic Systems Ltd (the UK Company) wrote to Professor Cash on 27 November 1989, intimating that an export permit had been approved by the FDA for the Ortho ELISA test.^[237] This meant Ortho could supply their product labelled for 'In vitro diagnostic use' instead of 'Research use only'. Dr Perry agreed in oral evidence that this was an optimistic early signal that the FDA would license the test for routine use within the USA.^[238]

31.155 On the same day, Ortho Diagnostic Systems Inc, New Jersey, faxed a second letter to Professor Cash, announcing that they had 'just completed production of a small number of prototype confirmatory tests in [their] RIBA (Immunoblot) format'.^[239] The letter provided some details of the test format. Ortho hoped at the time of writing to introduce this confirmatory test in the first quarter of 1990. The American company intimated that C-100 antigen (the HCV protein) could not be made available to investigators for testing at that stage. The faxed letter indicated that three separate bands of antigen were used in the RIBA.

31.156 The letters did not indicate that Ortho's ELISA had been approved by the FDA for use in the USA. One could not infer that the FDA had completed by this stage the investigations necessary for domestic purposes. However, it would be an over-cynical view to suggest that the FDA would release for use by the rest of the world a test about which it had material concerns. Dr Mitchell's report on the Rome Symposium referred to above noted that Ortho anticipated FDA licensing according to 'the agreed timetable'. The export permit was an encouraging development. It was sufficient for Finland and some other European countries to introduce routine testing in early 1990.

31.157 It appears to be clear that information about the RIBA confirmatory test was published at the Rome symposium discussed above. Dr Mitchell appended to his report of the symposium a circular distributed by Ortho giving preliminary information on a RIBA confirmatory test then currently under evaluation.^[240] The information was the same as set out in the faxed letter to Professor Cash on 27 November.

31.158 Dr McClelland was asked in oral evidence about the usefulness of the first RIBA as a confirmatory test. He commented that there was a general acceptance amongst most virologists that the immunoblot tests such as the RIBA and Western Blot 'were a useful addition and provided valuable extra information to interpret the result of a positive ELISA test'.^[241]

31.159 He commented further in his statement:

The advantage of RIBA or WB is that with these methods a sample that gives a positive reaction with a screening test can be further analysed to show the reaction of the sample with different components of the virus, and can give additional help in distinguishing a false positive from a true positive result.^[242]

31.160 Dr McClelland thought the RIBA represented added value and information.^[243] He added, however, that some groups of virologists, notably one led by Professor Tedder, felt the RIBA tests 'were a waste of time'.^[244]

31.161 Dr Dow had his own concerns about the value of the RIBA as a 'confirmatory' test. He commented in his statement:

[T]he first generation RIBA was based on only two specific HCV recombinant proteins which were both products of the same area of the genome (the non-structural (NS) 4 region). As both these recombinant proteins were the coating materials for the solid phase ELISA microwell, it was predicted that the same cross-reacting antibodies would produce (false positive) reactives in both ELISA and RIBA systems.^[245]

The end of 1989: comment

31.162 In the course of 1989, the NBTS and the SNBTS each obtained test kits from Ortho for evaluation. There is no evidence to suggest that they could have been obtained earlier. Dr Gunson and Professor Cash agreed that the two services should act in close collaboration and envisaged difficulties if either should introduce the test unilaterally. Each proceeded with evaluation.

31.163 By the end of August 1989, UK commentators appear to have formed a generally favourable view of the first generation Ortho test, but there were still reservations. Drs Contreras and Barbara were concerned about the predictive value of the test in low HCV prevalence populations, such as UK blood donors. Professor Cash, Dr McClelland and others thought that without a confirmatory test there would be serious problems for the Blood Transfusion Services in differentiating between true and false positives. There was concern that repeat and supplementary testing based on a common antigen source - both in initial screening kits and in the early RIBA format - failed to provide the confirmation required.

31.164 The preliminary report of the NBTS pilot study was available in June 1989, with a second report in January 1990. As finally reported, in April 1990,^[246] the study found that the first generation Ortho HCV ELISA tests appeared to have an acceptable level of specificity and sensitivity, albeit these issues could not be addressed definitively as part of the evaluation. There were no samples with well established links with NANB Hepatitis available to be tested.

31.165 While Dr Dow's study in October 1989 reported disappointing results in a group of 15 patients 'known' to be positive for transfusion-transmitted NANB Hepatitis, the study nonetheless concluded that the Ortho test had an acceptable level of specificity. There is no doubt, on Professor Cash's evidence, that the Glasgow laboratories were the most experienced researchers in this area in Scotland at the time. They were the right people to carry out the assessment of the Ortho ELISA kits.

31.166 As discussed above, a very different approach was adopted in Finland. The Finnish National Board of Health was open to advice from the Finnish Red Cross. The Red Cross did not need consent for the introduction of tests, but did need consent to raise prices: the consent was easily obtained. Professor Leikola was concerned at the lack of a confirmatory test but thought that, in light of the risk of chronic illness, since there was a test it had to be introduced. It was duly introduced in February 1990. Local circumstances are important. What was acceptable in Finland would not necessarily have been acceptable in the UK. Competent experts may reasonably take different views.

31.167 The Inquiry accepts that there would have been difficulties in introducing the Chiron test kit for routine use at the end of 1989. It was not licensed by the FDA for export until November 1989, the need for a confirmatory test had not been met and pilot testing in the UK was thought necessary. It is of concern, however, that there was no firm intention to recommend screening once these conditions had been met. On 9 October 1989 the ACTTD had Dr Gunson's report, agreed amendments, and was prepared to submit it to the ACVSB. From the terms of the amended report, the ACVSB was fully informed when it met on 6 November as to the conditions that had to be met for the introduction of the test in the UK. On the information available, FDA approval, at least for export, could have been seen to be imminent after the Rome meeting. The ACVSB appeared unwilling to go further than offering support for 'general introduction' if the three conditions were met, and to developing an economic case for the DoH to fund routine use of the test. The date fixed for the next meeting of the committee was 17 January 1990. It would be six weeks before the ACVSB was expected to resume consideration of the issue. Professor Leikola's surprise that there was no firm decision on 6 November is understandable. Associated with the lack of a firm intention to introduce routine screening, was the decision that there was no case for introducing surrogate tests for NANB Hepatitis. In combination, the decisions put action on hold over the end of 1989 and early 1990.

Events of 1990

31.168 The ACVSB met for the fifth time on 17 January 1990.^[247] The pilot study agreed to in November 1989 had been completed and approximately 5000 tests had been conducted at each of three centres, Brentwood, Birmingham and Sheffield. The percentage of repeatedly reactive donors at these centres was, respectively, 0.61%, 0.28% and 0.18%.^[248]

31.169 There was a full discussion of NANB Hepatitis and the issue of HCV testing. By now the FDA had approved the Ortho ELISA for export. Professor Zuckerman proved to be a powerful voice at that meeting. He recommended a delay in the introduction of testing until the FDA had approved the test for use in the USA and thought the FDA was unlikely to license the test in the absence of a confirmatory test (although by now information about the forthcoming Chiron RIBA confirmatory test was quite widely known).^[249]

31.170 It was also the understanding of Dr Rotblat of the DoH that the FDA was unlikely to approve the test at this stage. If the minutes are reliable, Dr Gunson did not comment that an export licence had already been granted. However, Professor Zuckerman added in a letter considered by the ACVSB that 'the introduction of screening could not be delayed much beyond FDA approval'.^[250] He noted in his letter that test kits were being developed by other manufacturers and added at the meeting that the committee should keep an open mind on other, newer test kits, which should be available within the next 12 months.^[251]

31.171 The minutes record mixed views from others in attendance. For example, Professor Tedder was reluctant to make recommendations at that time as so little was known about the virus and its antibody markers, but Dr Mortimer was keen to introduce screening and considered that if routine use of the test began there should soon be a better test to move on to.^[252] Dr Mitchell felt that it was possible to deal with donors who tested positive, without causing undue alarm. Dr Gunson explained that the transfusion services were under a great deal of pressure, not just from Ortho but from the press and, increasingly, from clinicians in the field. He felt that 'each centre must now consider how to set up the test and what extra resources they would need to do so'. In oral testimony Dr Perry denied there were widely divergent opinions at that meeting, just simply various views about different aspects of testing, according to individual areas of expertise.^[253] Cost was an important consideration, but a strict cost/benefit analysis was never a topic for discussion at the ACVSB.^[254]

31.172 Dr Perry told the Inquiry the ACVSB members did not vote.^[255] As a matter of procedure, each member had to express a personal view and it was for the Chairman to elicit such consensus as could be identified. The Chairman, Dr Metters, would summarise the main views of the committee and members were invited to agree or disagree with him.^[256] At this stage there was insufficient consensus to form a definite recommendation or decision.^[257] There was an emphasis on understanding scientific principles and a desire to be sure the test was appropriate before a policy could be announced.^[258]

31.173 The general consensus of this meeting was summed up by the Chairman: routine testing was not to be introduced in advance of the FDA decision and not enough was known scientifically at that time as yet.^[259] After further discussion the committee agreed that the costs of introducing testing in each region should be looked at now, Professor Zuckerman's figures on the number of possible cases of chronic liver disease that could be prevented by the introduction of testing should be further refined and the committee could give no further scientific advice at that point, but would discuss the matter further at the next meeting (in April) which would be after the International Hepatitis Meeting in Houston. There was no clear recommendation that testing should be introduced as soon as the FDA had given the green light to the US blood banks.^[260]

31.174 The minutes of the meeting recorded Dr Metters as saying that 'funding would have to be found from the existing ... allocation'.^[261] The minute clearly recorded Dr Metters' understanding of UK Government policy: there would be no new money for screening and health boards (at least in England and Wales) would have to find the necessary funds within their existing budgets.

31.175 Dr Perry's note of the fifth meeting of the ACVSB also recorded that:

[The] majority view was that [there was] sufficient evidence of test positive/infectivity correlation to justify implementation - overriding factor was question of product liability .... Agreed not to introduce test in advance of FDA approval but very compelling reasons to implement quickly following U.S. decision.^[262]

31.176 It was put to him in oral evidence that his note suggested that a 'fly on the wall' at the meeting, ie a completely independent observer, would have concluded that the committee was in favour of introducing the test, the deciding factor being the question of product liability. In response Dr Perry agreed that is how it read, and that while his hastily written note did not contain a full record all of the arguments put forward for and against the introduction of testing, it would have reflected at least the 'mood' of the committee as detected by him.^[263] Notwithstanding his reservations about his note, there is no reason to think that what Dr Perry recorded failed to reflect the discussion: yet the absence of any reference in the minutes of the meeting to product liability as a factor (when Dr Perry's note suggests it was the overriding factor in favour of implementation) raises a question whether the formal minutes fully reflect the discussion that took place.

31.177 On 16 March 1990 the ACTTD met for the fifth time.^[264] It noted that the ACVSB had at its last meeting deferred the decision to introduce routine screening of blood donations for anti-HCV.

Discussion at April meeting: change of tone since January?

31.178 The sixth meeting of the ACVSB on 24 April 1990^[265] was dominated by discussion of HCV testing. The meeting followed two symposia. One, sponsored by Ortho, was held in London in February 1990. The other, sponsored by Abbott, was held in Chicago on the same day as the Ortho symposium. Dr Andrzej Rejman (Senior Medical Officer at the DoH and member of the ACVSB Secretariat) attended the Ortho symposium. Dr Mitchell and Professor Zuckerman attended and reported to the ACVSB on the Abbott conference. Reports of the proceedings appear to have had a significant influence on the committee. In particular, one of the factors that appear, at least in retrospect, to have influenced the decision of the committee on HCV testing was the report of the Ortho symposium.

The Ortho symposium

31.179 Papers for the ACVSB meeting in April, circulated in advance, included documents apparently assembled by Dr Rejman and relating to the Ortho symposium. The papers included a brief synopsis of the contribution of each of a number of speakers, together with an abstract of the presentation of each speaker to the symposium. The bundle was prefaced with the secretariat's impressions of the event.^[266]

31.180 At the invitation of the Chairman, Dr Rejman opened the discussion on the Ortho symposium by expressing the view that 'the overall impression was that the test was not sensitive or specific enough for reliable testing' and that a confirmatory test and more information about the significance of positive results were needed before the Ortho test could be used for the routine screening of healthy donors. Dr Mortimer is reported to have said at the ACVSB meeting that there was an underlying feeling against screening because of the lack of confirmation tests, but that:

He thought confirmatory testing would become available within a reasonable time and that the routine screening of blood donors could not be delayed for a long time.^[267]

31.181 Professor Zuckerman, who again was a powerful voice at the meeting, echoed disappointment at the outcome of the symposium. He said that the non-specificity and sensitivity of the Chiron/Ortho test had been the main talking points at the London symposium.^[268]

31.182 Dr Barbara had presented a paper to the symposium on 'HCV and Blood Transfusion Service'.^[269] In his view, the ELISA test was a 'turning point of years of frustrating search' for the agent of NANB Hepatitis, but left many important questions for the transfusion service, which were being researched. In particular, his abstract stated that 'the predictive value of a positive anti-HCV result in a blood donor in relation to transmissibility of NANB Hepatitis is still under active study'.^[270] The imminent availability of supplementary tests from Ortho was welcome and was expected to reveal relevant information. Dr Barbara had also commented in his paper that Chiron had recently described cDNA polymerase chain reaction for HCV RNA which would shed some light on the infectivity of anti-HCV positive donors.^[271]

31.183 Dr Rejman's note of Dr Barbara's presentation recorded concern about how to address the issue of 'false-positive' donors. It struck a note of caution in the summary: 'Several "HCVpos[itive]'' donors have not transmitted either transaminitis or HCV. How can "false positives" be addressed, this is of great concern?'.^[272]

31.184 Dame Sheila Sherlock in her 'HCV and Autoimmunity' abstract presented at the London symposium, noted that, in that context, 'Clearly the relation of anti HCV to actual hepatitis C disease must be clarified. Better tests are needed for the hepatitis C virus'.^[273]

31.185 The summary of the paper by Dr G Dusheiko entitled 'Hospital diagnosis of HCV' concluded: 'The Ortho test is in its infancy, it is not infallible and there are no QC [quality control] panels available to check its reactivity'.^[274]

31.186 The notes of Dr Mortimer's presentation recorded further caution: 'There are no confirmatory tests at present .... The Ortho HCV [antibody] is a late [antibody], appearing 130-150 days post-transfusion .... Presence of [antibody] does not mean/imply infectivity'.^[275] Dr Mortimer had stated in his short abstract that the Chiron/Ortho test 'detects an antibody thought to be present in many who have been infected with HCV'.^[276]

Ortho symposium: a contrasting view

31.187 Following his attendance at the Ortho symposium, Dr Frank Boulton (Deputy Director of the Edinburgh Blood Transfusion Centre) wrote a letter on 21 February 1990 to Professor Cash,^[277] Dr Boulton felt very strongly that the screening of donors should be introduced at the earliest opportunity. The test was not perfect, but there was little doubt people had contracted HCV as a result of transfusions which they would not have received if there had been screening for HCV antibodies. He was concerned that the SNBTS would face future litigation from people infected with HCV from blood that could have been screened.

31.188 Dr Boulton had, in addition to a letter, composed a five page report of the material presented at the symposium.^[278]

31.189 The contrast between the negative tone of Dr Rejman's comments and Dr Boulton's observations raises issues, reflected in Dr Perry's evidence, as to the part played in the discussion by academic virologists, and about the role of the secretariat.^[279] Dr Perry suggested that, at this point 'the best [was becoming] the enemy of the good'.^[280]

31.190 Professor Cash said in oral evidence that he agreed with Dr Boulton's view. He had been satisfied with the results of the first study done in Glasgow. The specificity of the Chiron/Ortho test was acceptable. He thought at the time that no test for HCV was going to be perfect and 'something was better than nothing'.^[281]

The Abbott symposium

31.191 As noted above, Dr Mitchell and Professor Zuckerman reported to the ACVSB on a conference held by Abbott in Chicago on the same day as the Ortho symposium. Dr Mitchell brought back a list of guidelines dated 8 February 1990, issued by the American Association of Blood Banks (AABB), the American Red Cross and the Council of Community Blood Centres.^[282] Despite the absence of FDA licensing, these organisations were willing to issue guidelines for screening for anti-HCV. They directed that screening should commence as soon as FDA approval had been given. Professor Leikola thought they must have had some knowledge that the RIBA confirmatory test was coming, and consequently the FDA approval would not be far behind it.^[283]

31.192 Professor Cash sent a copy of the guidelines to Dr McIntyre at the SHHD with a letter dated 19 February 1990.^[284] According to a manuscript note on the letter dated 5 March 1990 (written by Mr Roderick Angus, SHHD^[285]), Dr McIntyre copied the guidelines to Dr Pickles of the DoH in London. Mr Angus went on to note that he had spoken to a civil servant in the DoH who told him the press statement had: 'stirred up a hornets nest. She asked for further info on it, in particular was the statement issued'.^[286]

31.193 Mr Angus himself commented in his Inquiry statement that he could not recall the specific circumstances but thought:

[I]t would be reflecting the unexpectedness of the American announcement and the expectation of calls for the immediate introduction of similar testing in the UK. The reference to having "stirred up a hornet's nest" reflects that unanticipated nature of the announcement rather than any anger felt by anyone.^[287]

31.194 Dr Mitchell thought Dr McIntyre's communication with the DoH indicated that there were significant developments on their way and, once the main impediment had been removed, screening should be introduced in the UK.^[288]

31.195 Professor Cash in his oral testimony did not disagree with the suggestion put to him that upsetting the 'hornet's nest' was caused by bringing into very sharp focus the likelihood of the USA introducing screening in early course, and this being at odds with the seemingly slow progress in the UK.^[289]

31.196 However, that apart, information about the AABB guidelines was clearly circulating within the SHHD and the DoH before the ACVSB meeting.

The ACVSB minutes

31.197 At the ACVSB meeting itself, Professor Zuckerman stressed that the major cause of PTH was the NANB virus. He commented on the Abbott symposium. He noted that there was evidence of different 'strains' of the Hepatitis C virus which would have serious implications for diagnosis and the development of vaccines. He commented on the findings of US studies showing that the predictive level of anti-HCV positivity for infection was about 77% and recommending that positive donors should be deferred. He also reported the results of testing Abbott's RIBA test and remarked on his view that the RIBA was not good enough to use routinely as a confirmatory test. He thought that the conference had been rather promotional in character.^[290]

31.198 Professor Tedder tabled a paper on the use of a modified PCR assay for the detection of HCV sequences in anti-C100 positive donations.^[291] The PCR test, unlike the ELISA and RIBA tests, detected Hepatitis C antigen, rather than antibody. Study had shown the method to be a useful confirmatory test for detecting virus particles in the bloodstream. The assay was not, in its present form, suitable for mass screening needs, but recent modifications of PCR technology indicated its potential for large scale-testing.

31.199 Dr Mitchell reported on proceedings at the symposium hosted by Abbott.^[292] He said that the vast majority of Hepatitis C cases were not transfusion-related. With high-risk groups, anti-HCV positivity was high, but in a cross section of blood donors concordance was much lower. As discussed above, he reported that the AABB had directed that testing for anti-HCV should be introduced as soon as FDA approval had been given.

31.200 Before opening the subject of testing to general discussion, the Chairman of the ACVSB, Dr Metters, reported that France, Belgium and Luxembourg had introduced routine screening of blood for HCV antibody. Italy had introduced the test on a voluntary basis. He went on to remark that, from the reports, the science seemed to have advanced little from the time of the previous meeting of the committee.^[293] There were still questions whether the anti-HCV test was reliable and a useful step forward or whether it still created too many problems at that stage.

31.201 After further contributions, the Chairman summed up the discussion:

• there was inadequate scientific data to support the introduction of the Ortho test for routine screening;
• a confirmatory test was needed which could be used in the RTCs and not just specialised laboratories;
• the FDA had not yet approved the test and it would be reassuring if the regulatory authority in the country of origin had done so;
• there was a need to learn more about the donor panels and the significance of positive reaction to the hepatitis C antibody test;
• a prospective study involving 25-50,000 donors would generate sufficient positives for confirmatory testing.^[294]

31.202 Dr Metters was concerned that there should be no confusion about the respective roles of the ACVSB and the ACTTD. He said:

The ACVSB advised Ministers on the virological safety of blood. The UKBTS Committee considered the operational implications of policy, gave the Department advice on safeguards against non-viral threats to blood and contributed to the advice on viral safety through input to the ACVSB.^[295]

31.203 The DCMO intended to write to Dr Gunson as Chair of the ACTTD in order to agree their respective roles. Dr Gunson was noted as confirming that he shared Dr Metters' view of the roles and thought there was no conflict between the committees. Whatever may have been the basis for the Chairman's concerns, the minute is further evidence that the decision whether to introduce HCV testing of blood donations was a matter of policy, to be decided by the government, on the basis of the expert advice of the ACVSB, rather than being a matter for the blood transfusion services. It is a matter for comment that, in emphasising the subordinate role of the ACTTD, Dr Metters implicitly accepted that it was the unqualified responsibility of the ACVSB to provide the government with the scientific advice required for formulating policy in this area.

31.204 Dr Perry said in his Inquiry statement that he could not recollect the DCMO providing an explanation at the time of the need for his statement of intent. He speculated that 'the statement was intended to be an assertion of the authority of ACVSB to make policy recommendations ... and that ACTTD was subordinate to this authority'.^[296] The question, however, is why such an assertion was required. It appears that, by this time, the respective roles of the ACVSB and the ACTTD had become an issue between them.

31.205 Dr McIntyre produced a note of the meeting for the SHHD that reflected the negative conclusions of the committee but confusingly recorded that 100,000 donors were contemplated for the proposed study.^[297] Rather than proceeding to recommend that testing should be introduced, with or without conditions, the committee decided to initiate a large prospective study to investigate the significance of a positive test result and a sub-group was set up to prepare a protocol.^[298] It was to include Dr Gunson and Dr Mitchell.

31.206 Dr Perry reported back to Professor Cash in a personal note.^[299] It was intended to convey his view of the meeting to a selected audience, whilst still being bound by the rules of confidentiality. Both he and Dr Gunson had felt there was sufficient data for testing to be introduced. He denied in oral evidence that he was suggesting in his note that the blood transfusion services were ready to introduce the test in April 1990. Rather, there was enough information for the government to make a policy decision that the test could, and should, be introduced in future. Other Western countries were beginning to introduce it and he thought the UK could adopt a more positive approach rather than hanging back and waiting for the science to improve.^[300] He told the Inquiry in his statement that he shared this feeling with Dr Gunson.^[301] He recalled this meeting as being the first point at which he thought there was information available to make a good case for the introduction of testing.^[302]

31.207 However, the outcome was that the meeting of the ACVSB on 24 April 1990 did not recommend the introduction of screening. Professor Leikola said in oral evidence about the material from the Ortho symposium:

It's very natural that in that kind of symposium, the investigators, they are not marketing people for this commercial manufacturer, but they want to have a critical approach to these tests and I think it's natural that they emphasise the fact that they have found, you know, that it's not a perfect test and so on. So much are not detected and so many are false positives also. But to draw this conclusion that it should not be introduced at that time, I think I, at least, couldn't make out of these abstracts.^[303]

31.208 With regard to Dr Rejman's comment that the test was not 'sensitive or specific enough for reliable testing', Professor Leikola pointed out in oral testimony that the tests were considered good enough by the Finnish authorities for screening to have been introduced in early 1990.^[304] Professor Leikola commented in his Inquiry statement that the 'change of attitude of the ACVSB between January and late April was remarkable'. He added: 'The reservations as to routine screening had meanwhile grown'.^[305]

FDA approval May 1990

31.209 On 2 May 1990, a week after the ACVSB meeting, the US FDA licensed the Chiron/Ortho anti-HCV ELISA test for use in the USA. Ortho announced on 4 May that the kits were being shipped to US blood centres and that screening of the US blood supply would commence immediately.^[306] The announcement added that Ortho was supplying anti-HCV test kits to Europe, Japan, Canada and Australia.

31.210 Professor Cash told the Inquiry in his statement, that FDA licensing was regarded as important. The scientific process of assessment of diagnostic kits by the FDA was rigorous. No kit licensing arrangements existed in the UK.^[307]

31.211 In his oral testimony Professor Leikola said that FDA licensing was not an important factor for the Finnish Red Cross. They had decided to proceed with the test based on their own observations and opinions on the Ortho kit. The earlier grant of an export licence to Ortho was enough for them to proceed, and they were not deterred by the possibility the FDA might refuse to license the test for use in the USA. Professor Leikola added that the FDA dealt with different issues when considering the blood transfusion system in the USA and their relationship with the blood banks and different laboratories. It was more complex in the USA. In Finland they had just one laboratory which had decided the test kit worked satisfactorily, and they did not expect the FDA to refuse to license its use 'in-country'.^[308]

31.212 If the FDA had refused to license the test in the USA, the Finnish Red Cross would have had to consider the reasons for that and decide if it was relevant to them and to consider any impact on their own screening system that might result. If there was something incorrect in the manufacturing of the test kit or inconsistencies between batches of the tests it would have impacted on the quality of the test kit and caused concern in Finland.^[309]

31.213 In a letter dated 11 May 1990, Ortho in the UK wrote to Professor Cash to confirm the arrival of its RIBA test: 'This exciting new assay is designed to detect the presence of antibodies to hepatitis C virus in samples that have given a positive result with the Ortho* HCV antibody ELISA test'.^[310] The letter from Ortho did not comment on whether the RIBA was developed as a 'confirmatory' or a 'supplementary' test, simply that it could detect the presence of antibody to HCV in samples which already tested positive with the ELISA. In later practice, the PCR test became the preferred confirmatory test as it detected the virus itself and was based on a different principle. Professor Cash considered the first RIBA to be a supplementary test, rather than a confirmatory test. But it did assist in convincing scientists that they had found a true positive.^[311]

July 1990 meeting of ACVSB brought forward

31.214 Dr Metters wrote to members of the ACVSB on 5 June 1990.^[312] He advised that the extended prospective study discussed at the last meeting to investigate the significance of positive findings from the anti-HCV ELISA test, was no longer considered appropriate 'in light of subsequent developments'. These developments were said to be (unspecified) additional scientific information that had become available and the fact that the FDA had approved the Ortho test for routine use in the USA. He indicated a fairly urgent wish to bring the next ACVSB meeting (which had been fixed for 24 July) forward to 2 July and devote it entirely to Hepatitis C testing and felt the committee now needed to consider whether UK blood donations should be routinely screened for Hepatitis C.

31.215 He set out the questions to be addressed:

1. What new information is available about the screening tests themselves, or on the use of supplementary (RIBA) and confirmatory (PCR) testing methods?

2. Has the FDA decision to approve the test and decisions of other countries to implement testing been influenced by some scientific or other information which has now become available?

3. Are there any advantages attached to either of the two tests currently available (Abbott and Ortho) in respect of specificity, sensitivity, operational ease of use, cost?

4. If routine testing were to be introduced what implications would this have for the UK BTS? How would positive fundings (sic - probably 'findings') be dealt with? What supplementary or confirmatory testing would be required and where would this be carried out? How and when would the donor be counselled?

5. If testing is to be introduced in the UK should it be limited to whole blood or also extended to plasma donations bearing in mind the supposed efficacy of heat treatment? Are all current methods of viral inactivation successful in respect of hepatitis C?^[313]

31.216 On 6 June 1990 Dr McIntyre wrote a memorandum to Dr Young (DCMO, SHHD) commenting on Dr Metters' letter and the fast moving developments that were taking place.^[314] Dr McIntyre had little doubt that the committee would recommend the introduction of the screening test. He remarked that the large prospective study planned at the last meeting was to be abandoned as it was no longer appropriate and advised that matters should be put on hold pending the ACVSB meeting on 2 July. Mr Panton of SHHD added a manuscript note to the memorandum, addressed to his colleague Mr Hogg, to tell him they should still press for funds despite the study being abandoned.

Further new study

31.217 The ACVSB met on 2 July 1990 for 'reconsideration' of the decision made at the committee's April meeting.^[315] Dr Rejman outlined the sequence of significant events: the FDA had approved Hepatitis C screening, the USA had introduced it and other countries were following. He said that more studies had been carried out confirming that Hepatitis C testing reduced infection, and that RIBA was available as a supplementary test. The minute does not identify the additional studies although the agenda noted that a summary of the basis for approval by the FDA had been tabled. The proposed extended prospective study agreed at the previous meeting was 'no longer viable'. Professor Zuckerman felt it was time for screening to go ahead on public health grounds, although he thought counselling would pose some difficulty.

31.218 After discussion, the committee concluded that it should recommend to Ministers that anti-HCV screening should be introduced, but that a pilot study was necessary first, to look at both the Abbott and the Ortho kits using the protocol drafted for the initial aborted study, to decide which was the better test kit.^[316] The first two questions posed by Dr Metters appear to have been disposed of without separate discussion. Further study would resolve question 3. Question 5 was dealt with on what appears to have been a sensible basis: antiviral treatment was not guaranteed to be effective, and consistency required that all donations be treated alike. The matter of counselling, as focused in question 4, was discussed: national consistency on this was required and the working group would continue to look at the whole topic of counselling.

31.219 Dr Gunson advised that Wellcome (a British company) was also developing a test which would be ready in September/October. The pilot study would go ahead without delay and frozen library samples would be kept so that donations could be retested later against other tests, such as Wellcome's, as they became available.

31.220 A draft proposal for a three centre comparative trial of the first generation Abbott and Ortho tests was circulated at the ACVSB meeting.^[317] The document noted that evidence from Finland indicated that supplementary testing at specialist laboratories should eliminate approximately two-thirds of the reactive samples. The comparison was to be done at North London, Newcastle and Glasgow RTCs, which would each carry out around 3500 tests. Confirmatory tests were to be carried out using Ortho RIBA, Abbott confirmatory test, and immunoassays based on other HCV proteins (if available). This study would take around four months to complete once finance was agreed. Contrary to the impression that might be created from the meeting having been advanced by three weeks, as Professor Leikola commented in his second statement, 'there was still no rush'.^[318]

31.221 According to Dr Mitchell, the comparative study was necessary because not all laboratories were using the same technology. Some were already familiar with Ortho technology and some with Abbott. It was important for the three laboratories involved to compare results from the two test systems and try to ensure they had detected the same thing.^[319]

31.222 Dr Perry thought the studies had different objectives.^[320] In his statement, he resisted the suggestion that the time taken for the second 'replacement' pilot study was wasted. It would be best practice for a new test system, in this case Abbott's, to be validated. It would be useful to identify any problems, or advantages, with wide-scale use of either of the kits.^[321] The second study would be looking at the relative performances of the two kits with a view to deciding if there were benefits from one over the other. The UK population could well have different characteristics from that in the US, and still relatively little was known of the Hepatitis C virus, so it made sense to look at both kits. If one kit had been better than another in one country, it did not mean it would be the best choice elsewhere.^[322] While noting these possibilities, Dr Perry did not suggest any difference in format or indicate any underlying scientific reason that might have led to an expectation that there would be major differences between the two tests.

31.223 It is observed in passing by the Inquiry that, in proposing this study, the ACVSB appears clearly to have been entering into the 'operational implications of policy' - the function of the ACTTD - and widening the area of responsibility accepted by the committee as articulated by Dr Metters on 24 April 1990. Having decided at their meeting on 2 July 1990 to recommend, as a matter of policy, that HCV screening of blood donors should be introduced, it is not clear why the ACVSB considered that it should become involved in deciding which test kit should be used by RTCs. On the face of it, that was an operational matter for the blood transfusion services, which fell within the remit of the ACTTD.

31.224 In any event, the ACVSB underestimated the time it would take to assess the results of the pilot studies and decide its next step. The final report of the tri-centre study, incorporating Phases I and II, was not available until February 1991. Professor Leikola observed in his second statement that 'the outcome of the 2 July meeting meant at least half a year's delay in the introduction of the screening. As it turned out, the time span was more than two times longer'.^[323]

31.225 Professor Leikola was asked in oral evidence whether, in his view, screening had to be delayed until the Ortho and Abbott comparison was completed. He accepted that the comparison was necessary, but he did not feel it justified a delay in the introduction of testing.^[324] He pointed out in his second statement that the comparison could have been undertaken while screening was up and running using the Ortho kit.^[325] It could have been introduced in May 1991, after the FDA decision to license the Ortho test, and screening could have been given the 'go ahead' in July. Professor Leikola would not have expected there to be a major difference between the Ortho and Abbott kits: both were based on the same protein and the same patent from Chiron.^[326] He noted that the philosophy in Finland was that 'if a new test seems to be inevitable, it pays off to start it as soon as possible, and then with flags waving'.^[327]

31.226 Professor Leikola commented in his initial Inquiry statement that a decision to introduce anti-HCV screening could have been made in June or July 1990:

[T]here was no clear mechanism for making a definitive decision concerning the whole UK. The time needed for practical arrangements in the blood centres could have been a maximum of four to five months, so the screening could have been in place in late 1990, possibly in October-November 1990.^[328]

31.227 This inevitably assumed a steady progression to implementation in a variety of blood transfusion centres once a decision had been made. Professor Leikola accepted in oral evidence that it would have been much more achievable in Finland with one centre than in the UK where there was a variety of transfusion centres and organisations.^[329]

31.228 In his first Inquiry statement on this topic, Professor Leikola was asked to comment on the reasons for the delay in the decision to implement anti-HCV screening in the UK. He thought they were threefold:

• There was a lack of a proper prospective study on the incidence of transfusion transmitted hepatitis. There had been studies, but they were too small.
• There was pressure from the academic scientists in the ACVSB and ACTTD who preferred a cautious view of the usefulness of the test kits for routine use.
• There was also reluctance on the part of some blood centres to introduce screening, which would have involved them discarding an appreciable amount of blood donations and having to counsel an increased number of donors.^[330]

In fact, on 9 October 1989, the ACTTD had recommended to the ACVSB that screening should be introduced (subject to conditions).

31.229 In September and October 1990 Ortho intimated that a second generation anti-HCV ELISA test and a second generation RIBA confirmatory test would soon become available for clinical trials.^[331] While the first generation ELISA detected antibodies to HCV non-structural (c100-3) antigen, the second generation ELISA detected antibodies to a combined, larger, non-structural (c200) antigen and a structural (c22-3) antigen. The second generation RIBA test was a four-antigen test, in which two additional antigens (c33c and c22) had been added to the first generation RIBA test (containing the c100-3 and 5-1-1 antigens). Two short papers presented at a Hepatitis C symposium in Los Angeles in November 1990 (attended by Dr Gillon, SNBTS, Edinburgh), concluded that the second generation ELISA offered improved sensitivity and specificity in a variety of clinical populations.^[332]

31.230 In the review paper published in 1993, mentioned in paragraph 31.133, Professor Leikola described the progress made with the introduction of second generation RIBA testing:

The sensitivity and specificity of the test have been improved by adding two more antigens to the assay, the non-structural protein C33c, and the structural core protein C22.^[333]

31.231 There were still reservations, however:

[T]he sensitivity of the confirmatory tests is not yet optimal, and it can be estimated that the true prevalence of anti-HCV antibodies in Northern European populations is approximately 0.05-0.1%, and it increases up to 1% or more in geographical areas where hepatitis viruses are more common.^[334]

November 1990 meeting of ACVSB

31.232 By the time of the eighth meeting of the ACVSB on 21 November 1990,^[335] a note had gone to Ministers intimating that the committee was in favour of introducing HCV screening. There was no indication whether or not Ministers had responded. It was anticipated that there would be a further submission following a decision at the meeting, as to which test would be most suitable.

31.233 At the November meeting Dr Gunson reported on Phase I of the tri-centre pilot study.^[336] Professor Cash said in oral evidence that one concern with using different kits was that a donor tested in Glasgow might be told they were positive for anti-HCV, but if tested in Edinburgh they could be negative. This was because different tests used different criteria and a borderline case could have different outcomes in different centres.^[337] In the event, Dr Gunson reported that there was little to choose between the two tests: transfusion centres could decide individually whether to use the Abbott or Ortho kit, which might depend on the equipment already in their possession.^[338] That was the only recommendation to come out of this study.^[339] The minutes record confirmation by several members that better (ie second generation) tests were being developed and would shortly be issued. The inconsistencies in test results were noted by Professor Zuckerman at the meeting.^[340]

31.234 It will be necessary to return later in this chapter to the detail of some of that discussion. At this stage, it is noted that the committee agreed that the UK should introduce screening as soon as practicable, with individual RTCs deciding whether to use the Ortho or the Abbott test.^[341] The minutes record that, 'A submission would go to Ministers regarding this significant policy decision and the Management Executive would consider the funding aspect'. Further action would depend on Ministers' policy decisions. Thus, there was no reference to any agreed method of informing the transfusion centres of the plan. No suggested date for introduction featured in the minutes of the meeting, although Dr Gunson reported some RTCs had asked for six months to set up testing.^[342] According to Dr McIntyre's note of the meeting, the Chairman suggested 1 April 1991 as a start date.^[343]

31.235 The committee discussed some of the practical aspects of the introduction of testing, such as counselling. Dr Gunson said that the ACTTD would meet to discuss the problems of counselling donors and to develop a strategy.^[344] Both Dr Gunson and Dr Mitchell felt that if the results of the pilot study giving six true positives out of 10,000 donors were borne out in practice, then counselling would be manageable.

31.236 With regard to this meeting Dr Perry said in his statement to the Inquiry that it 'was widely understood that DoH and UK Ministers had ... established the principle of a common start date for testing and this position was periodically reiterated at ACVSB'.^[345]

Communication of ACVSB decisions to Scotland

31.237 Dr McIntyre produced a note of the ACVSB meeting held on 21 November 1990 for his colleagues in the SHHD.^[346] He reported that 'some' members wanted to start screening forthwith, but that the Chairman suggested 1 April 1991 was more realistic. Dr Perry attended this meeting and it was not clear to him, giving evidence to the Inquiry, who were the 'some' in favour of the forthwith introduction of testing.^[347] There is no record in the committee minutes themselves of a suggested start date. The date may have been suggested in a discussion that took place 'off agenda'. It may not have been adopted as the consensus decision of the meeting or, for some reason, may simply not have been minuted.^[348]

31.238 According to Dr McIntyre's report, it was agreed that a submission would be drafted for the Ministers and copied to Scotland, Wales and Northern Ireland.^[349] It was also recorded in the minutes that a submission would be sent to Ministers.^[350] Mr Tucker explained that it was common for the DoH to send draft submissions to the individual health departments to demonstrate what they were putting forward to Ministers.^[351]

31.239 Dr Mitchell wrote a letter dated 23 November 1990 to Professor Cash following this meeting of the ACVSB.^[352] He did not give a date for the commencement of screening but reported that it had been decided:

To introduce testing for anti HCV using either the Ortho or the Abbott test depending on local circumstances and experience of individual RTCs. The exact date of introduction would be at the earliest practical moment but it was reiterated that the UK would proceed in unity.

31.240 Dr Gunson was to consult with English colleagues and distribute copies of his Phase I report to assess the likely update of the technical resources required and the likely start dates. There would be a report to the ACTTD meeting in Manchester in January.

31.241 It appears to be clear that steps were in hand to explore the practical implications of implementation in England and Wales. Northern Ireland was not mentioned in Dr Mitchell's letter, and it did not refer to any similar arrangement for Scotland. Professor Cash was not a member of ACVSB, as Dr Gunson was, and appears to have been left to consider the Scottish situation unguided by the ACVSB directly, with the benefit only of informal information from Dr Mitchell.

Professor Cash advances matters in Scotland, November 1990

31.242 It appears that there were informal contacts between Professor Cash and Dr Mitchell, since Professor Cash was able to inform SNBTS colleagues that he and Dr Mitchell had a common view of the way forward. In response to Dr Mitchell's report of the ACVSB meeting, Professor Cash wrote to the SNBTS directors on 27 November 1990:

I am advised by Ruthven [Mitchell] that we are a wee bit nearer to "D-Day" and we both believe that it would be to our corporate advantage to take a further step forward along the planning route.

It now seems clear that, in the context of quality, both the Ortho and Abbott kits ... are acceptable: the choice will be yours. We now need to know (as part of an information gathering exercise designed to obtain a UK consensus for a future simultaneous start date) when would be the earliest date you could start routine screening and have your counselling team in place.^[353]

31.243 Professor Cash was asked in oral evidence what he meant by 'corporate advantage'. He thought it was no more than a reflection of his anxiety that the SNBTS 'as a team, stayed as a team'.^[354]

31.244 Professor Cash's view, stated in oral evidence, of what was meant by a 'start date' was the point at which transfusion centres would be in a position to test all blood products on their shelves in order for them to be pronounced safe on the same date. For centres to reach that stage, however, he stated that he would have been willing to accept that different centres would have to unwrap their kits and start testing their products at slightly different times.^[355] A 'slightly' different start date would have been acceptable to him, as different centres had different logistical issues, but it would not have been acceptable for an individual centre to commence testing months in advance of the suggested date.^[356] His ideal was for the individual transfusion centres to aim for the same completion date, when they could say all of the units of blood on their shelves were safe.^[357]

31.245 There was to be further debate about the meaning of the term 'start date'. By the time Professor Cash wrote to Mr McIntosh four months later with the results of the agreements reached at the ACTTD meeting of 25 March 1991, the definition had been refined:

The definition of a start date now proposed will be exactly as stated - the date when routine HCV donation testing will commence. NBTS colleagues do not wish to accept the original proposal (which applied to HIV-1 testing) that the definition of a start date would be that on that date all RTC products issued would have been HCV tested.^[358]

31.246 The North of Scotland Transfusion Centre in Inverness replied on 6 December 1990 to Professor Cash's letter of 27 November. The technical aspects of testing could be set up at short notice, but a system of donor counselling would be complicated and take around two months to establish.^[359]

31.247 The South East Scotland region replied to Professor Cash on 19 December in a letter composed by Dr Gillon.^[360] The earliest date routine screening could start was 25 February 1991. They proposed to use the Abbott test system. Dr McClelland commented in oral evidence that the transfusion centre might have been ready in 'purely transfusion' terms, but in reality there would have been no ministerial approval or the necessary finance in place to proceed with screening.^[361]

31.248 Edinburgh and South East Scotland began preparations for routine testing in mid July, using stored samples to evaluate equipment. The SNBTS informed the Inquiry that its laboratory manager's records showed that the Edinburgh and South East Scotland BTS began testing all of their blood products for anti-HCV on 30 July 1991. That was done so that all products on the shelf on 1 September 1991 could be said to have been tested.^[362]

31.249 The Inquiry has been unable to locate any letters from other regional directors responding to Professor Cash's letter of 27 November 1990.

31.250 On 21 December 1990, Mr Canavan (DoH) produced a note seeking Ministers' approval to commence screening in the NBTS, as a public health measure in line with the unanimous advice of the ACVSB that screening should be introduced as soon as practicable.^[363] The note stated that, in view of the operational matters that needed to be discussed and finalised, it was unlikely that routine screening could be introduced before 1 April 1991.^[364]

Decision-making process in Scotland

31.251 The development, and the effectiveness, of the management structures of the SNBTS is discussed in Chapter 17, Blood and Blood Products Management. From 1978 there had been a blood transfusion sub-committee of the CSA Management Committee, with a wide remit and delegated powers to deal with blood transfusion matters.^[365] Notwithstanding the formal structural changes introduced in 1978, the Blood Transfusion Service would continue to be characterised by a high degree of local autonomy.^[366] In 1990 the management structure of the SNBTS underwent a process of change. There had been concern that there had been a lack of professional management of the SNBTS under the existing system. The post of SNBTS General Manager was created. SNBTS Directors were made accountable to the General Manager on managerial aspects and professionally accountable to the National Medical and Scientific Director. There was one central body, the Management Board, through which all policy and strategic decisions passed.^[367]

31.252 Mr David McIntosh was appointed as the first General Manager of the SNBTS in February 1990, and subsequently became Chairman of the Board of Directors in May of the same year.^[368] The Management Board met for the first time on 19 June 1990 to finalise its remit in the new structure.^[369] Mr McIntosh gave oral evidence to the Inquiry on 29 November 2011. Professor Cash, as National Medical Director, had tended to liaise with medical colleagues within the SHHD directly, by-passing the CSA. Mr McIntosh said that, formally, Professor Cash became the Deputy Chairman of the Board at the same time as he was appointed. In formal terms, the Medical Director was now responsible to the General Manager and not vice versa.^[370]

31.253 In his own view, Mr McIntosh had a clear understanding of what the relationships among parties should have been. As he saw matters, the individual health departments were responsible for presenting recommendations for decisions to their own Minister or Ministers.^[371] The Scottish Health Service of the day was responsible to Parliament through the Secretary of State for Scotland and there were Ministers who would be responsible to him for health matters. Mr McIntosh was confident that Scottish decisions would take into account views from England, but that decisions would ultimately be made separately in Scotland. Scottish 'compliance' with English decisions could not be assumed. He made the point that the SNBTS would not have acted on any significant policy initiative without the authority to do so from the Secretary of State for Scotland, filtered through to them by the Health Minister or civil servants at the SHHD.^[372]

31.254 Whether his analysis was technically correct or not, there was a perception within the SNBTS of the relationships of the several participants, and disturbing such equilibrium as had been established in practice would not be easy. There were tensions as Mr McIntosh approached his task, as he saw it, of seeking to improve the previous administrative arrangements for the governance of the SNBTS.

31.255 Mr McIntosh suggested in his statement that there were three periods of time in the lead-up to the introduction of testing: an initial period of 'genuine debate' about the necessity of HCV testing, a second period of 'genuine professional deliberation' and, from the end of March 1991 to the end of August of that year, a period of 'successive delays'.^[373]

31.256 It appeared to him that the view in Scotland in very early 1991 was that coordination with English implementation of testing was desirable and to be followed if at all possible.^[374] The bodies in England that were advising and guiding decision making in Scotland had no responsibility for patient care in Scotland.^[375] In formal terms, he was correct: the SNBTS was not directly dependent on Westminster funding. The allocation of expenditure from the Scottish block grant (determined by the Barnett formula from 1978) was purely a Scottish matter. But there was a single UK Government and, realistically, if there was a UK policy decision that screening should be introduced across the UK on a single date, reluctance to incur cost in England and Wales would have an indirect effect on what could be done in practice in Scotland.

Slippage at the start of 1991

31.257 Following on the DoH submission of 21 December 1990 seeking Ministers' approval to commence HCV screening of blood donors by the NBTS,^[376] Mrs Sandra Falconer (SHHD) produced the following note on 4 January 1991:

[Mr Kennedy, DOH, Belfast] wanted to speak to Rab [Panton] about Hep C submission. He asked if we had put forward to Minister yet and if we had funding. Explained we were still working on submission and that bid for funding had been made but you were awaiting Mr Panton's return on Monday to discuss PES allocation & finalise submission.^[377]

31.258 There was a meeting of the NBTS/SNBTS Liaison Committee on 7 January 1991.^[378] Dr Gunson attended and expressed his concern that the DoH had not yet decided on a start date. It was suggested that it was probable that a date in May or June 1991 would be the earliest possible. Dr Gunson added that he thought the major problems were mechanisms for finding the money for the RTCs in England and Wales and for confirmation testing. Professor Cash's notes of the meeting state, 'The issue was one of DoH's disinclination to fund centrally and insist on cross charging i.e. increasing the unit cost of blood supplied to hospitals'. Professor Cash requested a more definitive description of 'start date'. Dr Gunson advised him that would be discussed at the next 'Microbiology Advisory Group Meeting' on 8 January.^[379]

31.259 After an interval of 10 months, the ACTTD met again on 8 January.^[380] The minutes of the meeting noted that, 'It will be important for RTCs to start testing on an agreed date'. As with the ACVSB meeting of 21 November, the discussion on anti-HCV screening was dominated by setting out the details of the procedure to follow for positive test results. Dr Gillon attended and his paper on counselling of donors was also discussed. He agreed he would amend it in response to written comments from other committee members.

31.260 On 16 January 1991 a short government memorandum was issued on behalf of Baroness Hooper, Parliamentary Under Secretary of State for Health, in response to Mr Canavan's note of 21 December 1990.^[381] Screening for anti-HCV should be introduced as soon as practicable. No suggested date or timetable was given and no guidance was offered to suggest the commencement date. Baroness Hooper said there was no option but to introduce anti-HCV testing.

31.261 On 21 January Mr Tucker sent a memorandum to Mr Panton passing on the information from Mr Canavan, that DoH Ministers had given their approval to the submission on HCV testing.^[382] Mr Canavan did not know the start date, since some laboratories would require new equipment. There was to be a meeting of RTDs to explore the practical issues. Mr Tucker had suggested to Mr Canavan:

[T]hat it might be better to set a target of 1 April as the earliest possible date for introduction but leave it to Blood Transfusion Centres to come in line thereafter since to delay for the slowest could mean a long wait.

31.262 He asked Mr Panton to proceed with a draft Scottish submission to Mr Forsyth, and to ascertain the earliest date the SNBTS could commence testing, whilst maintaining a 'UK approach'. It is not clear from the face of the memorandum if it was sent on that date. There is a further manuscript note by 'SF' - who is assumed to be Mrs Sandra Falconer - and that suggests it was not copied to Mr Panton until 14 February. Even then he was asked to work on the second, unrelated issue of 'handling charges for blood', described in the memorandum.

31.263 Mr Tucker commented in oral evidence that he would have preferred to set a target date for the introduction of screening; he would not have been comfortable with going to his Minister without a start date.^[383] He suggested 1 April in his memorandum as the Public Expenditure Survey (PES) had been approved by Ministers in Scotland and funding was available for that date, adding in oral evidence: 'Then we could all move forward at the same time'.^[384] Mr Tucker thought there would be no point in the DoH, or the SHHD, setting a date for screening if the transfusion centres themselves were not ready. There would have to be close consultation among the parties involved in decision making and implementation.^[385]

31.264 On 22 January 1991, Dr Gunson sent a memorandum to the Regional Transfusion Directors of England and Wales.^[386] He advised them that routine testing would be put into action and asked for the earliest date they could commence screening. This appears to be Dr Gunson's equivalent to Professor Cash's letter to his Directors of 27 November 1990.

31.265 Dr Gunson's memorandum was copied to Professor Cash, who replied on 24 January.^[387] External factors - the kind of events that change history - had a bearing on what was practicable. On 14 September 1990, British forces were deployed to Saudi Arabia following Iraq's invasion of Kuwait. On 16 January 1991, the United States of America announced operation 'Desert Storm'. War had again impacted on the work of the SNBTS. Professor Cash advised Dr Gunson that anti-HCV testing could not commence until either the Gulf conflict had ended or the SNBTS teams had proved themselves able to cope with the pressures of both the conflict and HCV testing. The demands created in anticipation of the actual conflict were exhausting staff and Professor Cash judged that, when the troops went operational, the 'current frenetic activity' of the SNBTS would be sustained. Professor Cash added in his oral testimony that '90 per cent of the blood that was made available for British troops involved in the conflict in the Gulf came from Scotland'.^[388] In his letter of 24 January to Dr Gunson, Professor Cash went on to say:

We remain firmly committed to starting on the same day as our NBTS colleagues and if pressed by Ministers I would suggest, in the circumstances, a May/June date should be considered. However, I would much prefer to wait another month and then respond to your letter.

31.266 Dr McClelland agreed in evidence that the UK services, at that time, were preparing themselves for a potentially large number of casualties of the war in Iraq being flown to hospitals in the UK. In addition, the transfusion services were inundated with extra blood donations.^[389] In the event, the military offensive comprised an initial prolonged aerial bombardment and a ground assault which commenced on 24 February and which ended when Iraqi forces agreed a ceasefire four days later, on 28 February. However, by that stage, the preparatory arrangements in anticipation of conflict had impacted heavily on the SNBTS.

31.267 On this occasion Professor Cash was supported within the SHHD.^[390] Dr Gunson responded on 28 January, without reference to the demands created by conflict, and advised Professor Cash:

It was never my intention that anti-HCV testing should take place with great urgency. The reason I asked if it was possible to let me know by Tuesday feasible dates for the commencement of testing was because I have a meeting at the DOH on Wednesday to discuss this matter. It was not intended to pressurise RTCs to start testing in the immediate future which, I agree, is entirely impractical. For England and Wales, as you know, there is a matter of financial provisions for this testing to be sorted out.^[391]

31.268 The interpretation of this superficially rather puzzling letter is unclear. It may have been intended as support for Professor Cash, noting that England and Wales also had problems that might delay implementation. On the other hand, one cannot avoid the impression that Dr Gunson's views of the practicalities in England and Wales would always have precluded any commitment to urgent implementation of the decision to commence anti-HCV testing in the UK, including Scotland for the reasons noted above.

31.269 In the meantime, the evaluation of test kits continued. On 24 January 1991 Dr Follett advised Dr Gunson of initial results from the Glasgow study, which indicated that the second generation Abbott anti-HCV test 'looks most promising .... Clearly the inclusion of the new C22 and C33 antigens has transformed this test'.^[392] These antigens were introduced into the Abbott RIBA test, as indicated above.

Abbott's intellectual property problems

31.270 The intention to have an evaluation of 1000 Abbott ELISA kits was, however, frustrated. On 4 February 1991, Dr Follett wrote to Dr Gunson to say Abbott had supplied only four test kits. Abbott was prevented from providing further kits until 14 April as Ortho had taken out an injunction preventing their sale in the UK until after that date.^[393] As indicated above, Abbott's licence had included restrictive provisions protecting Ortho's access to the market for one year.

Postponement from 1 April 1991

31.271 Dr Pickles of the DoH composed a memorandum on 5 February 1991, copied to certain members of the ACVSB but not to anyone in Scotland.^[394] She commented that there were many problems with the proposed introduction of testing, such as choice of test, supplies, confirmatory testing and training of staff. Funding was still a very real concern. Following discussion with the RTCs, Dr Gunson had suggested to Dr Pickles that the start date should be 1 July, and she wondered if that would be too late. Dr Pickles set out her view:

My initial reaction was this would be OK. Attempting to go earlier would mean some stragglers would be left behind, the slight delay increased the chance of the finance being sorted out, and with the diversion of RTC resources to Gulf-related activities a short time date might not be feasible. Even that date was dependent on blood collection having been stable for the preceding 4 weeks, which should apply provided the ground war is over by then.

Do you agree? We will discuss in more detail at ACVSB, I presume.^[395]

31.272 1 July had now emerged as the date of implementation of screening in place of 1 April. It is of importance to note the position on funding in England and Wales. As noted already, Dr Metters had stated at the ACVSB on 17 January 1990 that no new money would be made available for screening: funding would have to be found from existing allocations. Dr Pickles' memorandum indicates that, over a year later, the problem of funding in England and Wales had still not been resolved.

Funding in Scotland

31.273 Formally, the funding structure in Scotland was clear. In summary, SHHD funding came from the Scottish Office budget which was ultimately tied to the Treasury. The SHHD had its own Finance section which was overseen by the Scottish Office Finance Department. The SHHD had responsibility for the overall management and financing of the Common Services Agency, which in turn funded the SNBTS.^[396]

31.274 Mr McIntosh agreed with this summary put forward by Mr Tucker. However, as he recalled, the CSA took no part whatsoever in the chain of command as he saw it. Effectively, the SNBTS reported to Ministers through the Home and Health Department. He could not recall any CSA interest in the process of the introduction of anti-HCV testing.^[397] This was consistent with the position that obtained generally, and as described in Chapter 17, Blood and Blood Products Management. The CSA was a conduit for budgeting and the allocation of funds, but it had no operational role in the formulation or implementation of policies directing or affecting the work of the SNBTS. Budgeting was provided through the mechanism of the annual PES; procurement was a separate issue.

31.275 Mr Tucker told the Inquiry in his statement that there was a national procurement process. The Health Departments would seek to negotiate contracts on a national basis with the aim of obtaining the best value for money. The SHHD would not negotiate alone for products, as it would not have the purchasing power of the national procurement programme.^[398] He added in his statement that SNBTS staff would not try to purchase outside of the nationally agreed contracts as it would have been far more expensive.^[399]

31.276 Mr Tucker commented that it was common for the DoH to take the lead in national issues. The SHHD was a smaller Health Department, with fewer resources; there was a general desire to make use of DoH resources. It made sense for the SHHD to be in partnership with the DoH and both obtained the same advice from the ACVSB. The DoH as the bigger organisation was better able to exert pressure on the Treasury.^[400]

Public Expenditure Survey

31.277 On the agenda for the SNBTS management board meeting of 12 February 1991, it was noted in relation to the Public Expenditure Survey 1990 (PES90) that of a total sum of £2.5 million available for new developments, £1.1 million would be needed for anti-HCV testing.^[401]

31.278 On 12 February 1991 the Management Board of the SNBTS met 'to review the firmed up PES proposals for 1991/92'.^[402] The agenda included testing for anti-HCV as 'Microbiological Screening - Anti-HCV'.^[403]

31.279 In the original bid (submitted to the CSA and the SHHD in June 1990),^[404] total capital and revenue expenditure of £1.332 million had been sought (capital of £50,000 and revenue of £1.282 million) to introduce anti-HCV testing in 1991/92. In the revised bid, £1.223 million (£106,000 of capital and £1.117 million of revenue) was sought for that purpose. A detailed breakdown was provided.^[405]

31.280 It appears that the meeting in February 1991 may not have completed discussion of the detail of the bid for anti-HCV screening. It was planned to continue the discussion at a further board meeting in April 1991. It is however clear that the bid for the funding of screening for HCV was included in PES90, that it was successful and that (in contrast to the apparent state of affairs in England and Wales) the funding was available to commence routine screening in Scotland in April 1991.

31.281 Mr Tucker commented in oral evidence that this implied that testing could begin in April 1991: the Minister had agreed testing as he had approved an allocation of funds in the PES for 1991/1992.^[406] He said that there was no allocation of funds for HCV screening in the PES for 1990/1991.^[407] That would have been drawn up in June or July 1989, and the need for funding would not have been known at that stage. The only money available for HCV screening in the financial year 1990/1991 would have been from the contingency fund, or spare money in the CSA budget. That led to a discussion of the use of the contingency fund.

Reserve/Contingency fund

31.282 The Inquiry asked the witnesses who provided statements whether, if screening had been introduced before the financial year 1991-92 (and specifically in year 1990-91), the money required could only have been found in the 'central reserve' (the contingency fund referred to in an SHHD memo of 2 July 1990).^[408]

31.283 All witnesses were referred to paragraph 2996 of the Minutes of the Meeting of the Management Committee of the CSA for the Scottish Health Service held on 20 June 1990:

The Committee noted the circulated paper dealing with plans for testing blood donations for Hepatitis C. It was likely that up to 100,000 tests per annum would be needed at a cost of £1.3 million. Should testing be started during the current financial year, funding would have to come from the contingency fund because there would be no additional finance available from Scottish Home and Health Department.^[409]

31.284 Mr Tucker explained in his statement that when the CSA received its annual budget allocation, 10% of each Division's budget would be held in reserve as a 'contingency fund'. Each element of the contingency fund was, however, related directly to the head of expenditure for which the PES bid had been made and was held in reserve for that head of expenditure. For example, the 10% of the budget for ambulances was held exclusively against any emerging needs of the ambulance service. The contingency fund was not available against unbudgeted expenditure generally.

31.285 Mr Tucker thought it was very unlikely, if screening had been introduced early, that the CSA could have 'raided' the contingency fund. If there was a good case for urgent funding to be found, the CSA would have examined its financial priorities in divisions other than the SNBTS and looked for any unspent money that could be utilised.^[410] If this was not possible the CSA could turn to the SHHD for unspent budgets. If this proved impossible, the request for funding for screening would 'go up the scale'^[411] to the Scottish Office Finance Division to see if there was unspent money from a division such as Transport if, for example, a planned roads project had not gone ahead.^[412]

31.286 There were different views. In contrast to Mr Tucker, Mr Roderick Angus commented in his statement:

As part of the Public Expenditure Survey outcome, the Common Services Agency, of which the SNBTS was a division, was provided with a sum of money to be used as a 'contingency fund' to meet any in-year funding needs, this was also referred to as a reserve in some correspondence. Mr Donald, General Manager of the CSA, would have, in the first instance, been expected to fund the testing from within that 'contingency fund' rather than seeking additional funds from the Scottish Home and Health Department.^[413]

31.287 He went on to say that the minutes of the CSA Management Committee 'indicate that had screening been introduced before the financial year 1991-92, it could only have been paid for from the reserve'. If the contingency fund had been insufficient, additional funds could have been requested from Finance Division.^[414]

31.288 Mr McIntosh commented in his statement that the Inquiry's assumption, as reflected in the question, that the contingency fund was the only source of funds for screening was 'probably not correct'.^[415] If it had been deemed necessary, Ministers could have brought implementation forward into the financial year of 1990-91. He thought it could have been financed in a number of ways which would probably include the use of the reserve fund. He felt confident that if the introduction of testing had been prioritised in the financial year 1990-91, the money for implementation would have somehow been found for implementation before 1 April 1991. Mr McIntosh confirmed his view in oral evidence that he did not believe that finance was in fact an obstacle in Scotland.^[416] He added that the SNBTS was not encouraged to think budgets were flexible, but he had found 'serious' amounts of money out of similar financial arrangements when necessary.^[417]

31.289 Another witness, Mr David Hogg (SHHD) commented in his statement:

Had the Hep C Testing commenced, however, within 1990-91 then technically the CSA/SNBTS would have to have funded from the remaining Revenue Allocation, including the 'Contingency Fund', although I am sure we within the Health Department would have gone back to Finance Division with a further in-year increased funding bid.^[418]

31.290 In the end, having regard to the evidence as a whole, it appears highly unlikely that funding in Scotland would have depended on technical budgeting issues: if a decision had been taken to commence screening for anti-HCV in Scotland in 1990-91 then the funds would have been found.

Start date becomes 1 July 1991

31.291 On 13 February 1991 Mrs Falconer (SHHD), sent a handwritten memo to Mr Hogg.^[419] She commented that she had spoken to Ms Elaine Webb at the DoH and was advised that 'officially no date has been given'. The date would be discussed at the ACVSB meeting on 25 February, but confidentially the start date was hoped to be 1 July. Ms Webb had commented that 'the Department of Health did not want SNBTS or anyone outwith the office informed'.

31.292 Mrs Falconer suggested in her Inquiry statement that it may have become effectively a matter of protocol. She observed:

I would suggest that DoH(E) colleagues requested that the 'unofficial date of 1 July' should not be shared because it would not be appropriate to suggest that a possible date had been set before the Advisory Committee had had an opportunity to discuss the matter at its meeting and agree a recommendation.^[420]

31.293 As her conversation with Ms Webb took place just 12 days before the ACVSB met, this appears to be a plausible explanation for the date remaining confidential until the committee had the opportunity to endorse it.

31.294 Mr Tucker offered a different explanation for this, however. He said that Ms Webb at the DoH was a junior staff member who had inadvertently given an official start date to her SHHD counterpart and tried to mitigate this by saying the SNBTS should not be told. She may also have been concerned the date could be forwarded to the NBTS via the SNBTS.^[421]

31.295 Mr Hogg made an observation in his statement on the subject of why the start date was not to be openly discussed. He observed that the date 'must have been subsequently confirmed at the aforementioned ACVSB meeting, as in D McIntosh's (SNBTS) letter to Dr McIntyre dated 12 March 1991 ... he clearly states 1 July 1991 as the agreed introduction date!'.^[422]

31.296 On 14 February 1991, Professor Cash advised Dr Habibi (Medical and Scientific Director, National Blood Transfusion Centre, France) that 'we (UK BTS) expect to start HCV donation screening in the early summer 1991 ...'.^[423]

31.297 On 15 February Dr Gunson wrote to the Directors in England and Wales to advise that screening would begin on 1 July 1991.^[424] He warned that, if the Gulf war continued and blood donation levels were still very high, this date might have to be reconsidered. There were still matters to be considered at the meeting of the ACTTD on 25 March.

31.298 Professor Cash wrote to Dr Gunson on 15 February, again saying he would like the SNBTS to stay in line with the NBTS/BPL.^[425] Professor Cash asked for a common understanding of what a 'start date' meant. He suspected Dr Gunson would have to pursue Dr Metters' committee (the ACVSB) on these topics.

Further slippage in timescale for introduction of screening

31.299 Mr McIntosh described the period between the making of the decision to introduce screening (ie in late 1990) and the end of March 1991 as including 'genuine professional deliberation, aimed at investigating the validity, accuracy, reliability and operational practicality of available test materials and methods'. He thought this investigation was completed in time for anti-HCV testing to have been implemented throughout Scotland by 1 April 1991.^[426] Funding for screening had been granted to the SNBTS and was in place for that date.

31.300 On 21 February, Mr Mark Fuller from the DoH wrote to Dr Contreras.^[427] The letter was copied to various individuals, including Dr Gunson and Dr Mitchell. At the meeting of the ACVSB on 21 November 1990, Dr Gunson reported that Ortho had brought out a second generation test, and had offered 2500 free test kits for use on frozen samples held at the North London Transfusion Centre.^[428] Mr Fuller's letter was headed 'DH sponsored second round evaluation of HCV screening kits North London BTS, Colindale', and appears to have taken up this project. Dr Contreras was asked whether she was happy for the work to be done at her Centre. The letter does not specifically state that there was to be an evaluation of Ortho second generation kits. However, the instructions were given by Dr Gunson and the context supports the inference that they followed from the intimation in November. Professor Cash was of the view, stated in oral testimony, that this represented evidence that a decision had been made by the DoH to carry out an evaluation of second generation kits, before HCV screening of blood donors was introduced.^[429] This is discussed further below.

31.301 The ACVSB met on 25 February 1991.^[430] Dr McIntyre attended as the SHHD observer. Dr Gunson did not attend and offered his apologies. The tri-centre study (North London, Newcastle and Glasgow) of the first generation Ortho and Abbott ELISA kits had been conducted in the second half of 1990 and a summary of the results of Phases I and II, dated February 1991, was presented to the committee.^[431] All three centres reported that the tests were easy to perform. The Ortho tests were producing more initial screen positives than Abbott, but the repeatable positive rate was similar with both tests.^[432] Dr Mortimer again reported results from the continuing pilot study. Significantly, he advised retention of the samples collected, for the evaluation of other candidate HCV tests, and that 'the Committee may wish to see the results from the second generation Ortho and Abbott tests'.^[433] Professor Tedder tabled a paper which led to discussion:

The Committee discussed the likely availability of the second generation tests and operational factors which might influence the decision by RTCs as to which screening test to choose .... Members agreed it was important for proper evaluation of the Ortho and Abbott 1&2 tests to be carried out before RTCs decided which test they would adopt.^[434]

31.302 The Chairman's summary noted agreement on retention of the samples and that:

Any new test should be evaluated against the full 10,000 specimens to ensure it was at least as good as the tests already evaluated.

Ortho and Abbott 1 and 2 should in principle be available among others from 1 July for RTC's to choose.^[435]

31.303 The minutes do not record a change in the date participants had in mind for implementation of screening.^[436] However, there was a clear weakening in commitment to any particular date, in so far as it was agreed that it was important for proper evaluation of the Ortho and Abbott 1 and 2 tests to be carried out before the RTCs decided which test to adopt, and availability of these tests 'in principle' by 1 July further qualified commitment.^[437] The idea of an evaluation, incorporating second generation tests so that the RTCs could decide which to adopt, appears to stem from this meeting.

31.304 However, that idea was not immediately appreciated. On 26 February Mr Bayne and Mr Panton of the SHHD met with Dr McIntyre^[438] who had attended the ACVSB meeting of 25 February.^[439] Dr McIntyre had confirmed the start date for screening was to be 1 July. Mr Bayne prepared a note of the meeting recording, in particular, that start date.^[440]

31.305 On 12 March 1991 Mr McIntosh wrote to Dr McIntyre on the topic of the 'Introduction of HCV testing'. Mr McIntosh referred in his letter to the 'agreed national (UK) introduction date (1 July 1991)'.^[441]

31.306 In a handwritten memorandum apparently dated 19 March, a message was sent by Mrs Falconer (who worked in the same Branch as Mr Panton)^[442] to Mr Hogg. It noted the date of commencement of testing as 1 July 1991 and queried 'What about submission?'. She suggested he read the note of the meeting with Dr McIntyre and Mr Panton, written by Mr Bayne. The tone of her note suggested that the submission to the Minister had not yet been drafted. This prompted a note, of the same date and handwritten on the same document, from Mr Hogg to Mr Panton: 'To see and discuss next steps re the submission'.^[443]

31.307 In addition, this document contains a note that appears to be in Mr Panton's handwriting: 'Draft submission based on English one - shorter version. Other Ministers have agreed'. While the note is ambiguous, and might mean that a submission had already been drafted as a shorter version of the English submission, it is more likely to have been a drafting instruction along the lines suggested. Mr Tucker suggested in oral evidence that it was an instruction.^[444] In his statement, Mr Hogg stated that he viewed it as an instruction that Mr Panton had addressed to him.^[445] It reflected the reality of the relationship between the SHHD and the DoH: advice to Scottish Office Ministers needed only to be based on the text of the DoH submission. There was no independent input required.

31.308 On 21 March 1991, the marketing manager of Ortho wrote to Professor Cash to advise that the second generation ELISA test was to be introduced, replacing the first generation test.^[446] On the same day, the NHS Procurement Directorate sent a letter (possibly implementing the decisions of the ACVSB made at the February meeting) to Dr Gunson in respect of a phase two evaluation of the HCV screening tests. The letter stated:

The Department has agreed that there should be a 'second-round' comparative evaluation of Hepatitis C kits at the Newcastle, North London and Glasgow Regional Transfusion Centres ....

The work to be carried out by the NBTS should start in February for the North London RTC and March for the other centres and be completed by the end of April. After this any repeat positive samples previously not identified will be sent to the reference laboratory for additional (and confirmatory) testing.

In consideration of the work to be carried out in Phase II the approved limit of expenditure ... shall be by quotation to Mr Fuller, from each of the centres .... The screening kits involved in the evaluation have been ordered from, Ortho Diagnostic Systems, Organon Teknika and UBI ....^[447] Tests from Abbott Laboratories will be done at Newcastle & Glasgow when available, the other tests being only done at North London.^[448]

31.309 As discussed below, just two days later, on 23 March, Dr Gunson telephoned Professor Cash to say that the commencement date for anti-HCV screening would be postponed. It is difficult now to understand why this should have been the case given that the letter from the Procurement Directorate expected the further evaluation to be completed by the end of April. Professor Cash could not explain this when asked in oral evidence. He observed, however, that the letter of 21 March to Dr Gunson from the Procurement Directorate, while very positive in tone, was from people who would not have 'the faintest idea' whether or not the kits were available. According to Professor Cash, Dr Gunson told him later the unavailability of second generation tests emerged as one reason for the delays.^[449]

31.310 The letter from the Procurement Directorate does refer to a March start for the evaluation in the Newcastle and Glasgow centres, in contrast to a February commencement in North London, suggesting a delay in the delivery of Abbott kits. In addition the letter makes reference to the Abbott kits being used at the Newcastle and Glasgow centres 'when available', possibly suggesting there was also a delay anticipated in the delivery of those kits. As noted above, Ortho's injunction against Abbott supplying further kits continued until 14 April, and this may have been the explanation for the anticipated delay. The evaluation was, however, expected to be finished by April and therefore would have been completed in time for a 1 July start date.^[450]

31.311 The general issue of delaying implementing a new screening test until a later generation of the test was available, was explored with Professor Leikola in his evidence to the Inquiry. Professor Leikola did not consider it necessary generally to delay the introduction of a test on the basis that better kits were on the horizon. In oral testimony he expressed the view that one would start screening with what was available and introduce better tests when they arrived. He did not think that time would be lost in the transition if a country had brought in screening with early test kits, and later replaced them with new and better kits.^[451]

31.312 He was asked if there was much work and time involved in introducing a second generation test to a laboratory which was already carrying out first generation testing. Professor Leikola thought that if the tests were basically similar, and did not require totally new machinery, it would not be difficult to do comparative tests on the two generations of kits to ensure the sensitivity and specificity had truly improved. He went on to say that the practicalities of actually introducing the new test would take time. First, the authorities would have to consider whether the manufacturer would be able to deliver enough of the new test kits. Secondly, work would be required to amend the legal agreements with the manufacturers of the first test, if necessary.^[452]

31.313 Professor Leikola's view was that, generally speaking, if newer, better kits were becoming available for use, the transition should have been made as soon as possible. Deciding not to introduce the old test because the new one was imminent could only really be justified if the manufacturer was very close to releasing the second generation test. If the new test would be only marginally better, there would be less urgency to introduce the second test.^[453]

The phone calls of 23-24 March 1991

31.314 Three telephone conversations regarding the postponement of the introduction of screening featured in evidence given to the Inquiry by Professor Cash. His was the only evidence available, and it became clear that the events were highly emotionally charged. Precise recollection cannot be expected. The first of the phone calls was made by Dr Gunson to Professor Cash at his home, on Saturday 23 March. The general topic of conversation was the upcoming meeting of the ACTTD on the following Monday, in Manchester.^[454]

31.315 According to Professor Cash, the first phone call was 'very acrimonious and distressing'. Professor Cash did not know that the DoH in London had decided there would be another 'field trial', this time on the second generation kits. He had understood from Dr Mitchell that evaluation of the second generation kits would be fitted in after the commencement of screening (using first generation kits) on 1 July, but Professor Cash then realised that another month would go by while this kit was evaluated, and he objected to the plan. Professor Cash recalled that Dr Gunson repeatedly claimed that the Scottish Office 'were party to this decision'.^[455] What precisely the Scottish Office was party to was explored in oral evidence with Professor Cash; he did not know if 'on board' meant with the carrying out of an evaluation of second generation tests, or 'on board' with the postponement from July to September.^[456]

31.316 Professor Cash was later asked in oral evidence why he did not confirm the SHHD position with them directly. He reiterated that, regrettably, 'Harold Gunson convinced me that SHHD had been party to the decisions that were made'.^[457]

31.317 Professor Cash recalled in oral evidence that Dr Gunson had been instructed to make certain that a trial of the second generation tests was agreed, and plans put in place by the time of the committee meeting on the Monday morning. The change of intention was that screening would not commence in July and instead there would be another field trial. According to Professor Cash, the idea had been abandoned, that evaluation of second generation tests could be fitted in after screening commenced on 1 July.^[458] Professor Cash added that he had initially refused to go to the ACTTD meeting on Monday and comply with Dr Gunson's wishes. This created 'acrimony' between the two friends.^[459]

31.318 Professor Cash told the Inquiry his initial reaction was to say, 'We don't need to delay at all'. In his view, other first world countries were starting to screen donors for anti-HCV using the first generation kits. Professor Cash was particularly concerned that the first generation kits would soon be unavailable as the manufacturers would withdraw them.^[460]

31.319 Dr Gunson telephoned Professor Cash again. According to Professor Cash's recollection of this conversation, it became increasingly clear to him that Dr Gunson was 'under extreme pressure to deliver a second generation field study and in doing so delay the onset of testing'. Dr Gunson agreed to send documents to Professor Cash that indicated the Department had signalled that this work was necessary. It was not a decision of the Advisory Committee. In Professor Cash's words: the Advisory Committee had been 'bypassed'.^[461]

31.320 During the second call, Dr Gunson gave Professor Cash an assurance that the NBTS directors would 'keep in line' with regard to delaying screening to allow for evaluation of the second generation tests. Apparently Dr Gunson had assured him that, 'if anyone got out of line at all, or thought about it, DoH would come down on them like a tonne of bricks'.^[462] It emerged in the call that a fundamental problem south of the border was one of 'funding and agreeing that funding system'. This was not a problem in Scotland. The funding situation in England was a deep-seated problem that Dr Gunson communicated to Professor Cash in the second telephone call.^[463] As already noted, the funding problem in England was not new: it had been recognised but left unresolved for over a year.

31.321 After further reflection Professor Cash telephoned Dr Gunson that Sunday, 24 March, to say he would agree to participate and that he would support Dr Gunson at the meeting in Manchester the next morning. He added it had been 'a matter of great regret to me ever since' that he did not insist that the whole of the UK should start implementing testing with first generation kits in the way other countries had done. Dr Gunson had told him that Dr Mitchell was 'on board' with the plan.^[464]

31.322 Professor Cash was asked how Dr Gunson knew that Dr Mitchell was 'on board'. He answered that Dr Mitchell had been copied into the letter he had received from the Procurement Directorate dated 21 March from Dr Gunson announcing a second generation study.^[465]

31.323 Professor Cash told the Inquiry in oral evidence that this became a 'painful' and 'personal' issue between him and Dr Gunson. He added:

Harold insisted that this was a device to give the Department of Health more time, more space, to resolve these very difficult financial problems that they had, and secondly, he insisted - this became very heated - that SHHD knew all of this and ... this is about the second generation evaluation, and the moment you sign up to that, July has gone.^[466]

31.324 Dr Gunson was unable to explain to Professor Cash why they could not just absorb the second generation tests after they had started using the first generation kits. Professor Cash came to his own independent conclusion that the DoH had 'devised a way' that gave them more time to sort out the funding problems in England and Wales. Professor Cash claimed to have discussed that with Dr Gunson, who did not deny it was a possibility but did not know for certain. Dr Gunson was, on Professor Cash's account, simply carrying out instructions.^[467]

Device of a further study

31.325 There appeared to the Inquiry to be two separate issues. First, there was the matter of postponing the start date because the English centres were not going to be ready due to funding problems. The second issue was a desire to do an evaluation of second generation kits, which would inevitably cause delay. Professor Cash was adamant the two were linked. His contention was that the evaluation of the second generation tests was promoted by Department of Health civil servants to buy more time to 'cover up' the fact that English centres were not going to meet the 1 July deadline because the funding was lacking. Professor Cash suggested the evaluation of second generation kits was used as a 'device' to justify the delay.^[468]

31.326 Professor Cash was asked if there was any reason why it was not possible to start screening using the second generation kits and thus to assemble evidence on how they performed. He agreed that it should have been possible. He thought that 'was done readily by half the world'.^[469]

Meeting of the ACTTD on Monday 25 March

31.327 Following the three distressing telephone calls between Professor Cash and Dr Gunson on 23 and 24 March 1991, Professor Cash said they had 'fallen out badly' but 'fell in again' shortly afterwards. Professor Cash, with 'some reluctance,' agreed to attend the meeting of the ACTTD on the following Monday (25 March) and not object to the second generation kits study and the delay in the introduction of testing.^[470]

31.328 The meeting of the ACTTD duly took place on the Monday.^[471] At point 4.11 the minutes record:

The proposed starting date of 1st July presented difficulties since it was considered essential that the second generation test from both Orth [sic] and Abbott should be evaluated prior to the commencement of routine tests.^[472]

31.329 There was reference to difficulties with the availability of both Ortho and Abbott second generation test kits. There was no official date for the launch of the second generation kit from Abbott.^[473]

31.330 There was an acknowledgement that 1 July looked difficult as a start date, but the minutes of the meeting did not go so far as to suggest a new date. There was a reference to Dr Gunson contacting Abbott to find out their availability date and then recommending a start date for the commencement of tests. There is no reference in the minutes to funding issues in England and Professor Cash could not recall if it was discussed.^[474] However, as noted above, when Dr Gunson wrote to Professor Cash on 28 January, and in later exchanges, it was taken as common ground between them that for England and Wales there was the matter of financial provision to be sorted out.^[475]

31.331 There is no reference in the minutes to 'decoupling' the second generation evaluation from the actual commencement of testing. There is also no suggestion that, given the problems with the availability of second generation kits, the UK should screen using available first generation kits and evaluate the second generation kits afterwards.^[476]

31.332 Professor Cash's position in oral evidence was that he did not suggest to the ACTTD that screening should start on 1 July with second generation evaluation being fitted in later, as he had promised Dr Gunson he would not say anything about it at the meeting.^[477] It was put to Professor Cash during his evidence that the minutes of the meeting of the ACVSB on 25 February 1991 suggest that it was the ACVSB that had decided that there should be an evaluation of the second generation kits and that that should happen before transfusion centres decided which test to adopt. Professor Cash disagreed with that proposition, however. He believed that the mechanism by which evaluation of the second generation kits would take place before transfusion centres decided which kit to use, was achieved and delivered by this meeting of the ACTTD.^[478]

31.333 Professor Cash wrote a letter to Mr McIntosh dated 27 March 1991^[479] following the ACTTD meeting and copied it to Dr McIntyre at the SHHD and to the Transfusion Directors. The letter stated that it was clear the NBTS was struggling to meet the 1 July commencement date and Professor Cash believed there was a fundamental problem with financial resources. Dr Gunson was to tell the DoH that the 1 July start date should be delayed until such time as an evaluation of the second generation HCV screening tests had been completed. If that was accepted it could push the start date to September. The impression created by Professor Cash's evidence was that this would be an indication that the recommendation to postpone had the backing of medical professionals.

31.334 Professor Cash stated in his letter that both he and Dr Mitchell supported the proposal that the start date should be pushed back to September. He explained in oral evidence that this was what he had agreed with Dr Gunson on the telephone that he would do.^[480]

31.335 Mr Panton added a handwritten comment to Mr Hogg on this letter to say that this was a 'worrying' development: they could not go to the Scottish Minister until they knew the start date. It appears to the Inquiry that this letter was the first indication that the SHHD had received that there was a problem with the proposed start date and a plan to postpone the introduction of screening.^[481]

31.336 Mr Tucker commented in his statement that there was no doubt in his mind that the Scottish Minister would have supported what was agreed by the English Ministers: 'This would have been the case irrespective of when our minute was submitted'.^[482]

31.337 With regard to NHS financial problems in England and Wales, Mr McIntosh told the Inquiry in oral testimony that he could not recall any briefings about this issue. He felt this backed up his 'secondary theory' that there were issues about money. Professor Cash was suggesting that he was aware at the time that the English were not implementing testing because of financial restraints in the regions, but was still encouraging Scotland to hold back and follow the 'party line'.^[483]

End of March to September 1991

31.338 Mr McIntosh described this period from late March to the end of August 1991 as including discussion of further validation and testing, but in reality creating successive delays in full implementation due to dedication to 'UK solidarity'. He commented in his statement that:

[T]he successive delays from 1st April through to 1st September were not made necessary by any considerations as to what would be best for patients in Scotland nor indeed by any Scottish issues. They were exclusively - rightly or wrongly - a direct result of the UK solidarity argument prevailing over other opinions.^[484]

31.339 He said that there was a group of Regional Transfusion Directors in the SNBTS who favoured implementation as soon as possible. They were opposed by people who were members of the 'UK solidarity camp', as he described them, and who were firmly of the view that all parts of the UK should implement testing at the same time. According to Mr McIntosh the 'UK solidarity camp' was 'best exemplified' by Professor Cash.^[485]

31.340 In Mr McIntosh's view, there was no real administrative control over the dates of commencement of testing. There was no mechanism for preventing one centre from starting to screen donors before other centres were ready and there was no mechanism for censure of a centre that proceeded before the global start date. Mr McIntosh commented that if there had been control it would have been exercised in reaction to the unilateral commencement of testing by the Newcastle centre discussed below.^[486] The only censure that the Inquiry is aware of was the suggestion, made by Professor Cash, of the exclusion from national committees of the head of the Newcastle centre, Dr Lloyd.^[487]

31.341 On 3 April 1991 Dr Gunson wrote to the Regional Transfusion Directors in England and Wales (and copied in Professor Cash) to advise it would not be possible to introduce testing on 1 July.^[488] It had not been possible to start the evaluation of the second generation Ortho and Abbott tests. One of the kits would not be available until later in April. The schedule would be too tight if the transfusion services tried to evaluate the second generation test, and commence screening on 1 July. It was difficult to give a precise date for the commencement of screening, but Dr Gunson thought they should aim to start by 1 September.

31.342 On 3 April 1991 Mrs Falconer was asked in a handwritten memorandum by David Hogg to 'Please check with DOH if they have considered a new start date ... and if they could advise us accordingly before we go to the Minister'.^[489] On 4 April Mrs Falconer sent a handwritten note to Mr Hogg to say the DoH was considering a new start date of 1 September 1991, but the date had not yet been finally agreed.^[490]

31.343 On 4 April, Dr Gunson wrote to the NHS Procurement Directorate in response to their letter of 21 March (as referred to in paragraph 31.308), above. The letter bore the heading 'Comparative evaluation of hepatitis C kits - phase II' and stated:

The timing of this study has slipped because of the unavailability of test kits. The Ortho 2nd generation tests have only arrived at North London RTC within the past few days and it is unlikely that the Abbott test kits will be available until the middle of April.^[491]

31.344 Dr Gunson stated in his letter that Dr Metters had agreed with him that the introduction of testing could be delayed until 1 September. In his evidence to the Inquiry Mr Tucker expressed the opinion that Dr Gunson appeared to be taking the decision himself.^[492]

31.345 On 5 April, Professor Cash replied to Dr Gunson's letter of 3 April and confirmed that, 'My colleagues would wish you to know that this most recent development, leading to a start date in September 1991, has the SNBTS Directors' fullest support'.^[493]

31.346 When pressed on the first occasion he gave oral testimony on this matter, Professor Cash conceded it was 'very probable' that he had written and recorded the support of his fellow directors without having specifically asked them.^[494] On the second occasion he gave oral evidence, Professor Cash was adamant: 'I cannot imagine ... that I hadn't in some way consulted with my colleagues'.^[495] He added later in oral evidence, 'I can't imagine I would have written it without ringing ... just to find out their views'.^[496] The Inquiry notes that Professor Cash's letter of 5 April was not copied to the SNBTS Directors.

31.347 On 11 April the DOH faxed Mrs Falconer (SHHD) the draft of a proposed letter, EL(91), to the Regional Health Authorities in England and Wales.^[497] It stated:

Ministers have agreed that screening of blood and plasma for HCV should be introduced as a public health measure now that suitable tests are available .... No date for the introduction of routine testing has yet been fixed but this is unlikely to be before 1 September 1991. You will be informed as soon as a date has been agreed .... No additional [funding] allocation will be made for the cost of testing in the HCHS budget for 1991-92 and Regions will have to meet the increased blood handling charges from their general allocation. The Department is negotiating a national maximum contract price for testing kits. Further details of this will be made known as they become available.^[498]

31.348 On 15 April, Mrs Falconer sent a note to Mr Hogg: 'Please see para 11 of draft DOH EL(91) which shows proposed date for introduction of HEP C screening not yet fixed but unlikely to be before 1 Sept 1991. Can we now put forward submission?'.^[499]

Newcastle starts screening

31.349 On 30 April there was an SNBTS/NBTS Liaison Committee meeting.^[500] It was suggested that a commencement date of 1 September would be appropriate. Dr Gunson reported that the general manager at the Newcastle Transfusion Centre, Dr Huw Lloyd, had commenced testing in the last week. There was no confirmatory testing being carried out and it was not clear whether positive donors were being counselled. Mr McIntosh immediately informed SHHD officials about these events. Dr Gunson had already advised the DoH of the same and 'advice was awaited'. Dr Gunson hoped to establish multi-centre evaluation of second generation kits with Newcastle as a participating centre. He expected an SNBTS centre would contribute to the evaluation.

31.350 The minutes of the Liaison Committee meeting go on to note that '[i]t was agreed that a firm clarification of policy was urgently required from DoH/SHHD within 7-10 days'.^[501] It is not clear on the face of the minutes whose responsibility it was to carry out that task as no initials appear next to that section of the minutes.^[502] When questioned later in oral evidence, Professor Cash commented that 'Harold would have gone back to [the DoH] .... David would go to the Scottish Office. Looking at seven to ten days, that's miraculous timing'.^[503]

31.351 Professor Cash could not recall if there was an attempt within that limited period of time to get clarification of a policy from the SHHD. He did not know if Mr McIntosh had gone to the Scottish Office to request clarification.^[504]

31.352 Dr Lloyd of the Newcastle centre wrote to all Directors of the transfusion services on 2 May 1991 and copied his letter to Dr Gunson and Professor Cash.^[505] In his letter Dr Lloyd stated that as Newcastle was already set up for testing, he had decided to keep to the July implementation date. His personal view was that to not test when there was the ability to test would be 'indefensible under the current Product Liability Legislation'. He commented: 'By 1st July all units of blood for transfusion in the Northern Region will be negative for Hepatitis C antibody'. There was a lead-in time to ensure all products were tested by 1 July, which Dr McClelland pointed out in oral evidence related to the shelf life of these products.^[506]

31.353 Dr Lloyd's letter generated a number of responses from other Transfusion Directors. On 7 May, Dr Mitchell wrote to Dr Lloyd with a hint of concern that screening had commenced so far ahead of the results of the evaluation tests. Dr Mitchell added that he presumed Dr Lloyd had 'started using the most appropriate test which you have validated on the results of the current three Centre evaluation of the 2nd Generation tests'.^[507]

31.354 Professor Cash wrote a letter about 'solidarity'^[508] to Dr Lloyd on 7 May to express his 'profound dismay' at this turn of events.^[509] The letter stated that Dr Lloyd's unilateral introduction of testing was both 'disgraceful and mischievous'. Professor Cash stated, whilst giving oral evidence, that he now regretted writing his letter to Dr Lloyd.^[510] He added that, looking back, he 'shouldn't have sent it, period, full stop'.^[511] Professor Cash did not ever believe Dr Lloyd's actions had been correct however.^[512]

31.355 Dr Lloyd wrote back to Professor Cash on 9 May. He personally believed that to start HCV testing according to the original schedule was the correct decision, even if others found it unpalatable.^[513] He went on:

To suggest that my action was ... "mischievous", is to impart motives to this action that were not mine. If you wish to question motives, then perhaps you should be asking why a vague September start date has replaced with little explanation, a firm date in July.

31.356 On 9 May 1991 J C Dobson, DoH, sent an internal memorandum by fax to a DoH official with copies to Dr Metters and others:

1. You will wish to be aware of a potential difficulty over screening for hepatitis C in blood donations, which may be picked up by the press.

2. Ministers decided earlier this year to authorise the routine screening of all donated blood for the hepatitis C antibody. After discussion within the NBTS a start date of 1 July was agreed but this was later delayed to allow evaluation of the "second generation" test kits. Despite this, the Northern Regional Transfusion Centre made a unilateral decision to start screening from late April.

3. Press interest is likely to focus on the prospect of the other Regions using untested blood, and may attempt to link it with the current interest in the settlement for haemophiliacs who were infected with the AIDS virus and the recent claims for compensation by people infected with HIV through blood transfusion.

4. I attach a background note and a line to take.^[514]

31.357 The memo by J C Dobson was also sent by fax to the SHHD, and in a handwritten note dated 8 May Mr Panton advised Mr Hogg: 'I have discussed this with Mr Tucker. We should put our submission forward about the 1 Sept start date and incorporate this: - Northern jumped the gun etc. Line to take for media enquiries'.^[515]

31.358 Dr Lloyd wrote a conciliatory letter in response to Professor Cash on 4 July. The two had met and mended their differences. Dr Lloyd expressed his concern that the UK was dragging its feet with regard to testing. Some of his staff had been concerned at the tone of the initial letter Professor Cash had written on 7 May and how it affected them.^[516]

31.359 Professor Cash wrote to Dr Lloyd for the last time on this topic, on 19 July.^[517] He emphasised the importance of the 'team approach' and the risk of exclusion if Dr Lloyd did not adhere to the team mentality. Professor Cash expressed his concern at the 'continued Balkanised mentality of BTS in England and Wales'. Dr Lloyd intended to be in Edinburgh the next month and Professor Cash invited him to take the 'opportunity of apologising ... to the SNBTS Directors'.^[518] Professor Cash, in oral evidence, admitted to some regrets about this letter. He added that Dr Lloyd did not accept the invitation to apologise personally to the SNBTS directors.^[519]

Consideration of earlier start in Scotland

31.360 Dr McClelland was asked about the position in Scotland, and the possibility of similarly going ahead with screening more quickly. He was uneasy about the delay in commencement and said in his statement that there 'certainly was consideration of an earlier start'. He recalled that the introduction of screening had been at the meeting of the SNBTS directors on 11 and 12 June 1991.^[520]

31.361 On the same theme, Dr Perry commented in oral evidence that in a practical sense it would have been possible for different parts of the UK services to have commenced testing at different times. He thought 'it would have been possible ... for the SNBTS to have gone ... on the original date of April'. He added: 'But underpinning the whole exercise was this UK common start date'.^[521] From a 'practical and political perspective' it would have been impossible; the SNBTS would not have had the authority from the SHHD or the Department of Health.^[522]

Public presentation of the further study

31.362 On 8 May 1991 Professor Cash faxed a letter to Dr Gunson in the immediate aftermath of the Newcastle decision. He suggested a national large-scale validation study, and added, 'We should make every effort to maximise this disaster to our corporate advantage'. It appears from the letter that it follows a previous discussion between the two on how to move on from the Newcastle events. The commencement of testing in Newcastle would be portrayed as a further, continued, study. Phase I would run until 15 July and it would be an exercise to assess the efficacy of the two different second generation kits. Phase II would run from 15 July to 31 August, in order to collect more screen test positives to assist in more extensive studies. This was described by Professor Cash in his letter as the 'public reason' for Phase II. It would allow the centres participating in the extended trial to continue to screen through to 1 September, and not have a break in between.^[523]

31.363 Professor Cash suggested the Glasgow centre might enter this national study. Glasgow and Newcastle would be the centres testing the Abbott kits and there would be two English centres testing Ortho kits. Professor Cash commented in his letter that Dundee and Inverness would be happy to 'pitch in' using the Ortho tests, but that their donation collections were relatively small and could be a disadvantage to Ortho. Funding was going to be a problem as it was becoming a larger exercise. Professor Cash was going to be on leave, and copied the letter to Dr Mitchell to ensure continuing SNBTS managerial support for Dr Gunson. It was also 'silent copied' to Mr McIntosh for reference.^[524]

31.364 In his oral testimony, Mr McIntosh considered whether or not Professor Cash had sought the Board's consent to offer the Glasgow centre into this study. He said:

It's inconceivable that we would have done this in Glasgow without the whole of the SNBTS management board having agreed it and the other RTCs being comfortable. So one has to assume that Edinburgh, Aberdeen, Inverness, Glasgow, Dundee would have known and were content at this time.^[525]

31.365 Despite extensive examination of documents from this short period of time in May 1991 when Professor Cash and Dr Gunson corresponded about which centres should evaluate the second generation kit, it has not been possible to find any documentary evidence that the matter was put before the SNBTS board for consent. It appears that the two National Directors decided together that Glasgow RTC would be one of the centres to take part in the evaluation.

31.366 There is a reference in Professor Cash's letter of 8 May 1991 to a 'public' reason for Phase II of the study. Professor Cash agreed in oral evidence it could be described as '[A] device. There is no doubt whatsoever'. He did not disagree that this suggested a degree of deception.^[526] He claimed his preferred option, in response to the Newcastle events, was for testing to commence in an orderly fashion without sticking rigidly to September as the start date and that Scottish centres could be in the first wave of the introduction.^[527] He wanted the Scottish Office to review the situation and give guidance on the next steps: 'it was a policy decision that had to be made by Ministers'.^[528] He had no recollection of putting this in writing to the SHHD and the Inquiry has found no evidence of written communication to decision makers at the SHHD from the SNBTS on this particular question.^[529]

Arrangements for the further study

31.367 On 13 May 1991 Dr Gunson produced a draft protocol including two new English RTCs, entitled 'Extended pilot trial of 2nd generation anti-HCV tests'.^[530] The protocol stated:

It is proposed to ask three RTCs in England and one in Scotland to undertake an extended trial of 2nd generation Ortho and Abbott anti-HCV tests. The RTCs using the Ortho tests are Liverpool and Leeds and those using Abbott tests are Newcastle and Glasgow.^[531]

31.368 Also on 13 May 1991, Professor Cash wrote to Dr Gunson (copied to Dr Calman and Dr Metters), in the week following the unilateral commencement of HCV screening in Newcastle. He stated:

It has always been the view in Scotland, both in the Scottish Office and throughout the SNBTS, that the introduction of additional microbiology donation screening tests would be subject to Ministerial approval. Our understanding of this issue goes back many years .... In recent times, evidence that Ministers wished to acquire a firmer grip on this activity came with the establishment of the Advisory Committee on the Virological Safety of Blood. This development, in principle, was warmly welcomed in Scotland.^[532]

31.369 On 14 May, Professor Cash wrote to Dr Mitchell at Glasgow Regional Transfusion Centre to 'confirm that Harold Gunson and I have agreed that West BTS should form one of the Abbott wings of the UK BTS Second Generation (HCV) donation testing study'.^[533] This study would ensure full donation testing in that region and would continue through to the proposed date for full screening on 1 September. It had been suggested by Dr Gunson that donor counselling would not feature during the study period. It appears that funding was no longer an issue: Dr Mitchell was asked to cost the exercise and let the SNBTS and John Francis (SNBTS, Finance Officer) know the figures.

31.370 On 14 May Professor Cash sent a long memorandum about HCV testing to the SNBTS Board members in response to an article in The Sunday Times of 11 May with the headline 'Victims to sue in new infected blood scandal'.^[534] This memorandum appears to be a justification, rather than a request for consent, for evaluating the improved second generation tests as the first generation tests were withdrawn. The memorandum states that:

[R]epresentations are being made, in the light of the developments in Newcastle RTC, as to whether, in future, the SNBTS is bound to a UK BTS approach with regard to donation testing, against a background of Ministerial involvement.^[535]

That implied an understanding on his part that the SNBTS had been obliged to adhere to a start date which was the same throughout the UK.

31.371 On 15 May 1991 Professor Cash wrote to Dr Gunson to thank him for his proposed protocol for the extended HCV trial.^[536] Professor Cash expressed his desire to encourage the participants in the extended trial to keep going after mid-July. He acknowledged this would certainly happen in Newcastle. He expressed concern that 'some people (notably David McIntosh!) may get very jittery'. Professor Cash balanced this with his view that the period from mid-July to 1 September would deliver a further batch of screen positive samples. This was described in his letter of 8 May as the 'public reason' for Phase II of the validation study. This would mean that, by the time full screening started, the SNBTS would be in a very strong position with regard to matching data on RIBA and PCR. This in turn would help enormously in the preparation of guidelines for future handling.^[537]

31.372 In oral evidence Mr McIntosh denied the description of himself as 'jittery' at the time.^[538] He was certainly 'very concerned', but in May of 1991 the anxiety about the date of introduction of screening had not reached its later heights. The SNBTS was still hoping to proceed quite soon.

31.373 Mr McIntosh said later in oral evidence that his recollection was:

[N]ot that I got jittery when the news of Dr Lloyd's action became known; I got jittery, and increasingly so, from April onwards because we [SNBTS] were not doing what we ... were encouraged to do, which was to introduce screening as soon as reasonably practicable.^[539]

31.374 On 15 May 1991 Drs Hughes and Macvarish (Glasgow and West of Scotland BTS), reported on their evaluation of the second generation Abbott anti-HCV ELISA.^[540]

31.375 At the meeting of the SNBTS Medical and Scientific Committee on 16 May 1991 it was noted that the best estimate for the commencement of routine anti-HCV screening was 1 September 1991. The minutes confirm that Professor Cash had told Dr Gunson the SNBTS could 'self-fund' the second generation study in Glasgow.^[541]

31.376 Mr McIntosh suggested in oral evidence that the extended trial was a delaying tactic and a 'cover' for the fact that funding was not available throughout the UK. Funding was available in Scotland from April 1991, but not in England. In his opinion England could not afford it so pressure was put on Scotland not to proceed.^[542]

31.377 In practice, as a result of including Glasgow and West of Scotland in the UK Phase II study of anti-HCV testing, nearly half of all SNBTS blood donors were already being screened and would continue to be screened as part of the continuing evaluation exercise, until the commencement of UK- wide routine screening superseded the evaluation. In other words, from some point in May 1991, around 50% of Scottish blood donations was screened for anti HCV due to the West of Scotland Transfusion Centre taking part in the pilot trial of second generation Abbott and Ortho test kits. Anti-HCV positive donations would have been set aside. Dr Perry was not sure what happened to the donors, whether they were simply screened out or told and counselled. He thought that, as the months progressed through 1991, the policy of a common UK start date was becoming harder to reconcile and sustain.^[543]

31.378 The period in 1991 leading up to the introduction of screening was a confused time, according to Dr Perry. There was a confirmatory test in place and the FDA had granted a licence for the Ortho kit. The date for commencement slipped from April to July and then to September, despite a policy decision having been taken by the ACVSB in November 1990 that the UK should introduce HCV screening as soon as practicable, with individual RTCs deciding whether to use the Ortho or Abbott test. The appearance of the second generation tests in early 1991 did not assist. There were rumours of funding difficulties during this time. In his oral evidence Dr Perry commented that the process 'could have been tighter'.^[544] He thought that issues were considered and decisions taken by the ACVSB on an incremental basis. Long-term issues such as counselling and follow-up were not considered until the initial policy decision was taken to introduce screening.^[545]

31.379 Dr Perry thought the delay in mid-1991 was caused partially by attention being given to the introduction of the second generation test. As a result first generation kits were dismissed, whereas other countries had been content to introduce them.^[546]

31.380 Dr Perry said in his statement that 'the actions of Newcastle Transfusion Centre ... whilst widely deprecated, were seen to potentially undermine the rigidity of a common UK starting date, or indeed the enforceability/validity of a "DOH policy'''.^[547]

31.381 Mr McIntosh recalled that he and Dr McClelland had, by May/June 1991, become concerned about the lack of progress regarding the implementation of testing. The SNBTS was able to introduce it, but was held back by waiting for the common UK start date.^[548]

31.382 The ACVSB held a meeting on 21 May 1991.^[549] The Chairman referred (under 'AOB') to the existence of 'the policy for a uniform starting date ... endorsed by all UK Health Ministers' and noted that, despite Northern region's action, 'this policy remained firm'.^[550] The policy appeared to have been firmed up. The trial of second generation kits had resulted in the decision that individual RTCs could decide themselves which test kit to use from Ortho 2, Abbott 2 or UBI.^[551] Mr McIntosh made the point in oral evidence that, as the ACVSB met in confidence, he would not have been aware of the policy and it would not have affected his role in Scotland.^[552]

31.383 Dr Gunson presented details of the proposed extended trial to the ACVSB meeting.^[553] This related to the extended trial of anti-HCV tests on blood donations which would now include data from the English, Northern region (Newcastle).

SNBTS Board meeting, Stirling, 11-12 June 1991 and its aftermath

31.384 The minutes of a two day SNBTS Management Board meeting in Stirling in June 1991 record, simply and rather tersely under the heading 'Anti-HCV testing', the words 'Agreed - Routine donation testing to begin on 1st September 1991'.^[554] Professor Cash agreed in oral evidence that the short note regarding HCV testing was not an accurate record of the discussion that led to the decision that was taken. He did not disagree that the discussion was essentially whether or not Scotland should announce 'a UDI' ('unilateral declaration of independence') which, in this context, meant Scotland introducing testing ahead of the rest of the UK, as had been done at Newcastle.^[555]

31.385 Dr McClelland composed a letter dated 11 June, addressed to Professor Cash, on the subject of anti-HCV testing.^[556] He wanted the matter to be discussed at the Directors' meeting and was concerned that the fact some centres were testing, albeit on a trial basis (in Newcastle and Glasgow), left the SNBTS very exposed. Dr McClelland wrote:

I would like to be reassured that we are taking the correct decision, both professionally and medical legally, to stay in line with the positions of the majority of English RHA's [Regional Health Authorities]; I think this is in fact what we are now doing rather than abiding by a Department of Health policy because it seems to me that de facto, [there] may no longer be a Department of Health policy in this area.

31.386 It is not clear if Professor Cash received that letter in time for the board meeting of the same date.^[557] The letter suggested, generally, that the issue of the introduction of screening should be discussed. Professor Cash agreed in oral evidence that it was an appropriate topic for discussion at the board meeting.^[558] He recalled at one stage in his oral evidence that:

'[W]e [the SNBTS Board] initially got into a general debate with Brian [McClelland] ... responding to the points he was making in his letter ... it was either Brian or David McIntosh that made the move, that triggered off the sad deterioration in the meeting.'^[559]

31.387 Dr McClelland had no personal recollection of that meeting, or the discussion on anti-HCV screening. However, he provided the Inquiry with his own handwritten notes of the meeting,^[560] and the section relating to anti-HCV screening was later transcribed by him at the behest of the Inquiry.^[561]

31.388 Dr McClelland recorded in his notes of the meeting that Professor Cash had stated at the meeting that: 'The UK pack is still a pack'.^[562] Professor Cash commented in oral evidence that, he was 'reporting back that at that moment, with the exception of Newcastle, the position was being held'.^[563] He added that at the time, 'the UK was operating, with the exception of our friends in Newcastle, as a single unit in respect of this topic'.^[564]

31.389 Dr McClelland had also recorded a further comment at the meeting: 'Can we make a strength of this by demonstrating that we have considered the early start option and rejected it in the interest of support/buttressing a coordinated national service'.^[565] Professor Cash was unable to say whether that would have been a record of him speaking, but noted that it appeared on the same line as his initials.^[566] Mr McIntosh agreed in oral evidence that it appeared to record the decision that was taken.^[567]

31.390 Dr Perry recalled in his statement that, despite Glasgow's involvement in the extended study from May 1991, 'SNBTS Directors remained supportive of a common UK start date, perhaps partly in the belief that SHHD would be unwilling or unable to countenance independent Scottish action'. He recalled further that:

[T]hese issues were considered and debated at some length at the SNBTS Board Meeting on 11th/12th June, although it was finally agreed to remain firm on the agreed date of 1st September 1991 ... as is very briefly recorded in the minute of that meeting.^[568]

31.391 Dr Perry recalled that 'very substantial discussion' took place and that there were differing views at the Board meeting on the issue of the introduction of screening.^[569]

31.392 Mr McIntosh recalled that the Stirling meeting gave the SNBTS the opportunity to have a 'serious discussion'.^[570] He thought that in some ways it is 'good practice' after a 'heated debate' with a clear outcome and decision to simply record the decision.^[571] In his statement to the Inquiry, Mr McIntosh set out his own memory of that debate, which he would have chaired. Funding was in place in Scotland, ministerial approval had been granted and operational matters ironed out.^[572] Professor Cash recalled Mr McIntosh supporting Dr McClelland's view at the Stirling meeting.^[573]

31.393 Mr McIntosh did not think Professor Urbaniak would have supported early implementation but he thought Dr William (Bill) Whitrow from Inverness and Dr Ewa Brookes in Dundee 'shared concern'. Mr McIntosh also suggested that Dr Perry, although not a regional director, shared the concern of Mr McIntosh and Dr McClelland. He was doubtful that 'sharing his concern' amounted to a willingness to vote against the views of the medical director.^[574] The views which Mr McIntosh expressed were described by him as 'anecdotal and from distant memory'.^[575] His views are disputed by some of those who attended the meeting and it is not now possible for the Inquiry to resolve the difference.

31.394 There was no evidence, according to Mr McIntosh, that any civil servant had instructed the SNBTS to postpone until further notice the planned introduction of HCV testing on 1 April. The SNBTS was funded to introduce the test, not authorised to delay it.^[576]

31.395 On 17 June 1991 Professor Cash wrote again to Dr Gunson:

Picking up the pieces after last week's near disaster up here.

Could you please:

1. Give me a date when all 2nd Generation Test Study data will be on your desk.

2. Give me the date when the Report (on the 2nd Generation Test Study) will be completed and the recommendations sent "to the Minister".^[577]

31.396 The Inquiry probed the reference to 'picking up the pieces after last week's near disaster up here'. The majority of witnesses thought this referred to the Directors' meeting of 11 and 12 June and the proposed early implementation of anti-HCV testing in Scotland. Mr McIntosh was adamant in oral evidence that Professor Cash was referring to his pride in having averted the disaster of Scotland going ahead, alone, to start screening for anti-HCV.^[578]

31.397 Professor Cash agreed in oral evidence that 'last week's near disaster' was the prospect of the SNBTS going ahead with early screening, and 'doing a Newcastle'.^[579] If the SNBTS had gone ahead with screening at that stage, given the declared position of the Scottish Office, it would have been a breach of trust with them. He found this to be 'unacceptable'.^[580] He remarked in his statement that the Stirling meeting involved a hotly contested debate on the proposed early introduction of anti-HCV screening. The proposal was defeated, but if approved he feared 'it could have triggered a descent into chaos', with the risk of another potential 'disaster': the possible fragmentation of the UK BTS and the SNBTS.^[581]

31.398 The minutes of the June meeting were not approved until the 21 August Board meeting, when Mr McIntosh thought they must have been approved by everyone.^[582] He could not recall, as suggested by Professor Cash, asking for the first draft of the minutes to be amended so that a report of the anti-HCV testing debate was removed from the record.^[583] Mr McIntosh's evidence on this point seems preferable given that the agenda for the Board meeting of 21 August - enclosing a revised copy of the draft minutes of the June meeting - stated that the draft minutes had been revised in light of comments by Professor Cash and others, but make no mention of Mr McIntosh having commented on or having sought to revise the draft minutes.^[584]

Ministerial approval in Scotland

31.399 On 25 June 1991 Mr Hogg sent a note to Mr Panton asking, 'can we discuss the submission format now ...'.^[585]

31. 400 On 1 July 1991 Dr McIntyre wrote to Dr Metters asking if the paper by Tedder et al in the British Medical Journal,^[586] reporting 'strong evidence for the sexual transmission of the Hepatitis C virus', would pose problems for counselling donors found to be Hepatitis C positive and would, in turn, be 'likely to result in any changes in the policy decision to implement routine screening on 1 September'.^[587]

31.401 On 11 July 1991 Dr Metters replied to Dr McIntyre's letter of 1 July. The UKBTS Advisory Committee on Transfusion Transmitted Diseases was preparing advice for transfusion centres about counselling donors and would have regard to all of the latest information from the various studies. Dr Metters did not anticipate that advice from that Committee would influence the date of the introduction of routine hepatitis screening.^[588]

31.402 On a copy of Dr Metters' letter, a handwritten note from Mr Panton to Mr Hogg dated 17 July 1991 stated: 'We can now proceed with the Hep C submission. We must get it up this week before Recess'.^[589]

31.403 It appears that the submission seeking approval for the introduction of routine testing of blood donations for anti-HCV did not go to Mr Forsyth (Minister of State with responsibility for health) until 24 July 1991.^[590] This is in contrast to the submission for England and Wales, dated 21 December 1990.^[591] Mr Tucker explained in oral evidence that the Scottish submission was delayed because it could not go to the Minister until a date for introduction had been set.^[592] The submission would have been worked on by other civil servants before coming to Mr Tucker for a final check, prior to being forwarded to the Minister with the start date.^[593] Mr Tucker thought approval in principle had already been given for testing, as the Minister did not object to its inclusion in the PES. The Minister turned the submission around in two days and was content to endorse the recommendation.

31.404 The Scottish submission noted:

In anticipation that testing would be introduced in 1991/92 a PES bid was lodged and this was successful .... The costs for 1991/92 will be in the region of £700,000 and as indicated above this has been already included in the CSA allocation.^[594]

31.405 A draft press release was prepared which stated: 'The annual cost of the testing is in the region of £1.2 million and the Scottish National Blood Transfusion Service has been allocated additional funds to cover this'.^[595] A copy of the submission, and a draft press release, were sent to the DoH by fax on 25 July.^[596]

31.406 On 26 July Mr Forsyth's Assistant Private Secretary replied to Mr Tucker to advise that the Minister agreed to endorse the recommendation that routine testing of blood donations for Hepatitis C antibody should be introduced in Scotland from 1 September 1991.^[597]

31.407 The press release was issued on 2 September, in almost identical terms as the original draft produced at the end of July.^[598]

31.408 Mr McIntosh was convinced when he gave oral evidence that the Minister must have had some awareness of the issue of screening as it was in the Public Expenditure Survey budget from April 1991 onwards.^[599] He thought the Minister must have signed off on it for the money to have been authorised. He assumed the SNBTS budget would have been 'built' in the autumn of the year before.

Screening introduced in September 1991 - retrospective views of the process

31.409 On 8 August 1991 Mr Panton wrote to Mr Jim Donald at the Common Services Agency.^[600] He stated: 'I am writing to formally advise you that the Minister of State has agreed to the routine testing of blood donations for the antibody to the Hepatitis C virus (HCV) from 1 September 1991'. Funding was already in place and there were arrangements to be made that were necessary to allow testing to commence.

31.410 On 12 August Professor Cash wrote to Mr Donald in response to his fax of 9 August.^[601] The communication of 8 August from Mr Panton had triggered the final phase of a programme agreed at the SNBTS board meeting in June.

31.411 On 29 August Professor Cash wrote to Mr McIntosh regarding the Stirling meeting and the SNBTS Board decision to stick to the uniform start date. He had recently read the minutes of the 21 May 1991 meeting of the ACVSB and noted the Chairman's comments that '"the policy for a uniform starting date has been endorsed by all UK Health Ministers"'. Professor Cash went on to say in his letter, 'I think we made the right decision at our Board Meeting on 11/12 June 1991'.^[602]

31.412 Mr McIntosh replied by letter the very next day.^[603] In it he communicated his conviction that they had taken the best decision available to them and expressed, with reference to the ACVSB minute, a degree of regret that such a record of clear UK policy had only come to his attention indirectly, through unofficial channels, and at such a juncture. He conveyed his belief that in the future, policy decisions potentially affecting the SNBTS should be conveyed to them, both formally and clearly, by the relevant authorities. He concluded his letter by noting that 'I remain convinced however that we can do a lot better next time than we managed, collectively (UK wide), to achieve over HCV'.^[604]

31.413 On 1 September 1991 the SNBTS (and the regional transfusion centres in England and Wales) finally introduced HCV screening of all blood donors using second generation ELISA and RIBA tests.

31.414 Professor Cash responded to Mr McIntosh on 16 December 1991.^[605] Professor Cash commented in oral evidence that the delay in replying was a result of him trying to think of what they could do about the situation.^[606] By contrast, Mr McIntosh wrote back immediately on 17 December.^[607] Professor Cash had noted in his letter that he was delighted with Mr McIntosh's response. Mr McIntosh commented in oral evidence that Professor Cash was 'being very supportive'.^[608]

Preparation of a history of events

31.415 An ad hoc meeting was held at the National Directorate of the NBTS on 13 September 1991 to consider the implications of the introduction of anti-HCV testing.^[609] The group comprised Dr Gunson, Professor Cash, Dr Mitchell and Professor Tedder. It was agreed that, in order to answer questions which might arise in the future with respect to the timing of the introduction of HCV antibody testing, the facts and decisions taken should be set out in chronological order. The minute of this meeting (revised on 5 February 1992) set out an account of Ortho's progress with their test systems, including their approaches to UK transfusion interests; Abbott's correspondence about their test; and the proceedings of the advisory committees.

31.416 This history of events may have been prepared in case, at a later date, questions were to arise as to whether there had been a delay in introducing HCV screening of blood donors in the UK. The minute did not refer to the following:

• The weight given to the lack of FDA approval of the Chiron/Ortho and anti-HCV ELISA test for use in the USA which was a factor down to 2 May 1990 when licensing of the test was announced (paragraph 31.209).
• The major concerns about funding in England and Wales that were explicit from at least 7 January 1991 (paragraph 31.258), underlined by Dr Pickles' memorandum of 5 February 1991 (paragraph 31.271) and which led to the DoH supporting Dr Gunson's suggestion of a start date of 1 July 1991.
• The ACTTD meeting of 25 March 1991 at which the difficulties in meeting the start date of 1 July were discussed (paragraph 31.330).
• The Newcastle initiative and its impact on the planned uniform start date.

Witnesses' views on the process

31.417 In an attempt to understand how more than two years passed between the launch of kits to test for the Hepatitis C virus and the introduction in the UK of screening of donated blood using such kits, the Inquiry included in the list of questions for witnesses a request for their individual opinions on the matter. The request was framed with reference to Mr McIntosh's letter of 30 August 1991 to Professor Cash.^[610] This letter appeared to recognise that there had been failings in the process leading to the introduction of screening. In providing their statements, witnesses were asked to say whether they agreed with Mr McIntosh's views. Views which witnesses expressed in answering this question were then explored in oral evidence.

Dr Perry

31.418 As previously explained, Dr Perry was a member of the ACVSB. In the statement he provided to the Inquiry, he set out a considered response to the question seeking his views on possible failings in the process leading to the introduction of screening. His response was as follows:

My personal view is that the early decision to introduce new blood safety measures on a UK wide basis and on a common start date was correct. However I believe there were a number of shortcomings in the overall UK management process ultimately leading to a late delivery of that outcome. These included:

• Unnecessary secrecy and confidentiality associated with the considerations of ACVSB and other 'behind the scenes' discussions.
• Absent or confused processes for communication of ACVSB decisions to operational managers.
• A late recommendation in principle ... by ACVSB and DOH for the introduction of HCV testing. This appeared to be driven primarily by scientific rigour rather than urgent public health considerations.
• The apparent absence of a clear plan, timescale, strategy or policy guidance (from either DOH or SHHD) for the introduction of testing following the decision in principle by ACVSB in July 1990 to introduce testing.
• The progressive (and largely unexplained) deferral of the UK start date from April to July to September 1991 believed to have been caused at least in part by administrative and funding issues between the English services and DOH rather than operational readiness.
• With hindsight, and given its readiness (both operational and financial) to introduce testing in early 1991, the failure of SNBTS to robustly argue a case for earlier introduction of testing in Scotland with SHHD/Scottish Ministers including the public health consequences of delays. Equally an SHHD apparent reluctance to consider such an option preferring instead to be guided exclusively by timescales determined by DOH.^[611]

31.419 In oral evidence, Dr Perry adhered to the views expressed in his statement. He also agreed that insofar as operational matters were being left to the ACTTD, the gap in meetings of that committee between March 1990 and January 1991 did not assist.^[612] He described the period following the meeting of the ACVSB in November 1990 as 'particularly confused'.^[613] In relation to the implementation of a decision to introduce screening, it would have helped if there had been 'scenario planning', addressing in advance what practical steps would be required should a decision be taken to introduce screening.^[614] Part of the reason for the lack of such planning was the limited communication of the deliberations of the ACVSB. This was due both to the insistence on confidentiality and to there being no structured approach to communication by the officials who attended the meetings; these officials were there to communicate back to operational bodies such as the SNBTS matters which were important for planning and policy purposes, but such communication appeared to Dr Perry to have happened only on a sporadic basis.^[615]

31.420 In relation to the composition of the ACVSB, Dr Perry's view was that the membership could have been more broadly based.^[616] By that he meant that there could have been people, 'with a slightly greater public health perspective on it',^[617] although he did pay tribute to Dr Mortimer, who was an expert virologist who brought a useful public health perspective to discussions.^[618] Dr Perry observed that this was not a process failure, as the membership was determined at the outset of the process.^[619] In this regard, however, the Inquiry notes that the membership did change during the period 1989 to 1991 and an additional member or members with a public health background could have been added.

Dr McClelland

31.421 Dr McClelland had noted in his statement that he agreed there were 'failings in the process' leading to the introduction of HCV screening^[620] and expanded on this during his oral evidence. In his view, 'something about the nature and the functioning of the institutions concerned in the UK, was profoundly different [from other countries] and led it to actually being one of the last countries to institute Hepatitis C testing'.^[621]

31.422 In focusing on the implications of the policy for a common UK start date, Dr McClelland observed that those involved in trying to implement screening 'should have been much more open to recognising that there were problems in certain parts of the country and looked for a way of managing a phased introduction'.^[622] He considered that the perception that non-A non-B Hepatitis was a US problem was relevant to the perceived 'lack of urgency'.^[623] The composition and chairmanship of the committee was also relevant. The focus was 'very virological, very transfusion process-orientated and there wasn't a loud enough voice ... saying: what about the patients?'.^[624]

31.423 Dr McClelland suggested that the SNBTS could have worked harder on 'influencing, through Scottish Home and Health Department, civil servants and medical officers... through influencing them, influencing the Minister to make a decision that on this issue Scotland needed to get on with it and go it alone'.^[625]

Mr McIntosh

31.424 In providing his views to the Inquiry, Mr McIntosh drew a distinction between his impression at the time, according to his recollection in 2011, and opinions he had formed in hindsight. He concentrated on the period after 21 November 1990, when the ACVSB had agreed at its meeting that the UK should introduce Hepatitis C screening of blood donations as soon as practicable.^[626]

31.425 In Mr McIntosh's view, the policy at the beginning of 1991 was that there should be coordination between Scotland, on the one hand, and England and Wales on the other, and that the start date for screening should be 1 April 1991 across the UK.^[627] Funding was in place for screening in Scotland; the target date of 1 April 1991 was, and remains in hindsight, 'a highly appropriate date for full implementation throughout Scotland'.^[628] Had a comprehensive brief been sent to the SHHD in May 1991 and had the up-to-date position and consequences been explained to Ministers, they 'would surely have decided to authorise the immediate introduction of testing throughout Scotland'.^[629] Instead the revised SNBTS position was not put to the SHHD or Ministers until the end of July 1991,^[630] at which point the SHHD formally asked Ministers to endorse the commencement of testing on 1 September 1991. The timing of the submission to Ministers in Scotland made it clear that the department 'was not leading but following'.^[631] The most important reason that Ministers in Scotland did not grant approval for the implementation of testing in the first six months of 1991 was that they were not asked or advised to do so.^[632]

31.426 In Mr McIntosh's opinion, it should have become clear from the first quarter of 1991 that an unsatisfactory outcome was on the cards; more should have been done to have policies and a strategy properly determined and committed to paper, with ministerial approval in place before the end of March 1991.^[633] If there had been a formal departmental brief issued at the beginning of 1991, the SNBTS could have been working towards implementation in Scotland in April or perhaps May 1991. Mr McIntosh made the point that different starting dates between Scotland and England/Wales would not have meant a lack of coordination and cooperation.^[634] In the absence of an instruction from the SHHD, there should have been, in Mr McIntosh's view, a strategy document from the SNBTS to set out for the CSA, for the SHHD and for Ministers 'the shape and size ... of the problem'.^[635] He set out an example of what such a memorandum might have said.^[636]

31.427 What occurred in practice however was that all guidance was coming to the SNBTS via second-hand reporting of advice, recommendations and pronouncements from bodies not part of the SNBTS chain of command. The roles and authority of the ACVSB and the ACTTD over the SNBTS were not clear.^[637]

31.428 Mr McIntosh saw as the key lesson that:

When faced with an ambiguous policy background and a lack of clear leadership from above on an issue as important as this one was, the Service itself must take the lead, on its own responsibility and focusing firmly on its key patient care responsibilities.^[638]

Professor Cash

31.429 In his statement, Professor Cash told the Inquiry that he agreed with Mr McIntosh's view that there had been failings in the process, and added that he thought there had been 'a good deal more than failings!'.^[639] In elaborating this answer in oral evidence, Professor Cash referred to the difficulty for the SNBTS in having input to the meetings of the ACVSB.^[640] There were also, he thought, failures of communication and of transparency.^[641]

31.430 Professor Cash also expressed the view that, had an approach been made to the SHHD in the summer of 1991 to propose the introduction of screening in Scotland ahead of the rest of the UK, it would not have been successful.^[642]

Discussion

31.431 In closing submissions, Counsel to the Inquiry advanced eight questions in this area.^[643] They were:

1. When it became apparent in 1988 that tests for the hepatitis C virus were shortly to become available, was there a satisfactory mechanism for determining whether these tests should be introduced for the screening of donated blood in Scotland?

2. When it became apparent that the introduction of screening for hepatitis C might be recommended, was there a satisfactory mechanism for determining when and how the introduction of screening in Scotland would be effected?

3. Whether the existence of two groups with similar remits (the ACVSB and the ACTTD) impeded decision-making.

4. The factors which contributed to there being no decision until November 1990 to recommend to Ministers that screening should start as soon as practicable until November 1990.

5. Why was there a delay of almost ten months between the decision by the ACVSB on 21 November 1990 to recommend the introduction of screening as soon as practicable and the introduction of screening in Scotland on 1 September 1991?

6. Whether, during this period, the involvement of the Health Minister earlier than July 1991 would have led to earlier introduction of screening.

7. The formulation of policy regarding the coordination of the start date for the introduction of screening in Scotland, with the start date for England and Wales, the flexibility of such policy and whether such policy as existed resulted in delay in the introduction of screening in Scotland.

8. The relevance to the decision-making process of the Consumer Protection Act 1987, and the relevance for the consideration of this Inquiry of the decision in A v National Blood Authority [2001] 3 All E R 289.^[644]

The last question raises matters of law. It is convenient to address it first.

31.432 In the litigation referred to in question 8, 114 claimants who were infected with the Hepatitis C virus from treatment with blood or blood products raised proceedings under the Consumer Protection Act 1987. These claimants were all infected after 1 March 1988, the date when the provisions of the Act came into effect, but before screening was introduced in 1991. The defendants were the National Blood Authority and others, essentially all those who were, or had become, responsible for the production and supply of blood and blood products in England and Wales. During the course of the litigation, it was agreed that the claims of those infected after 1 April 1991 would no longer be opposed (on the basis that these claimants would receive 90% of the damages to which they were entitled). Thus, the judgement does not scrutinise in detail the course of events after that date.

31.433 When before that date testing of donated blood should have been introduced in England and Wales was considered by Burton J in great detail, based on an analysis of the factual and legal position, almost all of which involved examination of the same events as were discussed before the Inquiry. There were arguments in relation to surrogate testing, which was never introduced, and in relation to the delay in starting to test all donated blood for antibodies to the virus.^[645] To a minor extent, some evidence emerged at the hearings of the Inquiry which was not before Burton J and, of course, he did not consider any circumstances specific to Scotland.

31.434 This exercise - that is, determining questions of liability under the Consumer Protection Act 1987 for the non-introduction of Hepatitis C testing, - did not involve the law of negligence, but a matter of statutory liability, based on underlying European legislation. As Burton J expressed it:

What is to be done is, as against what did occur, to set out what I may be persuaded should have occurred, in the round. This involves my looking realistically as to how much time it is legitimately to be expected that the producer should have taken to introduce the precaution which he did rightly introduce but, as the Claimants allege, later than he ought to have done had he taken all legitimately expectable steps.^[646]

31.435 In the part of his judgement dealing with the delay in introducing what Burton J refers to as 'the assay', a table is set out to illustrate the position in the 25 countries referred to by the parties to the case.^[647] These countries are in Europe, with the addition of the USA, Canada, Australia and Japan. The table shows that of those 25 countries, the last two to introduce screening for Hepatitis C were the UK and Ireland, in September and October 1991. Burton J concluded that the basic requirements which had to be satisfied before screening could be introduced were the carrying out of pilot studies and evaluations, the planning for counselling and implementation and the execution of that implementation in respect of equipment, staff and building works. In light of his assessment of how long these steps should have taken, he concluded that, as a matter of fact, routine screening ought to have been introduced by 1 March 1990.^[648]

31.436 This Inquiry is not bound by the decision of Burton J. It was reached in a different jurisdiction and it addressed a different question, namely that of legal liability to a group of claimants. But, as already observed, the case involved examination of the same factual material as did the investigation of this topic by the Inquiry. The decision (that after 1 March 1988, by which time surrogate testing should have been in place, blood and blood products infected with the Hepatitis C virus did not provide the safety which persons generally were entitled to expect) was not appealed. Before the Inquiry, there was no attempt to argue that the delay in introducing anti-HCV screening until September 1991 was justified, or even reasonable. The Inquiry has therefore started from the proposition that there was unjustified delay in introducing screening, and has tried to analyse how it occurred.

31.437 The issues which are highlighted in the remaining questions set out above at paragraph 31.431 are all relevant to the task of trying to identify the factors which led to the delay. These issues are addressed in the discussion which follows. It is appropriate to comment first on the two main advisory bodies, the ACVSB and the ACTTD.

The ACVSB and the ACTTD

Was a new body required?

31.438 When it became apparent in 1988 that tests for the Hepatitis C virus were shortly to become available, there was no satisfactory mechanism for determining whether these tests should be introduced for the screening of donated blood in the UK as a whole, and in Scotland in particular.

31.439 To some extent the constitutions of the two committees that emerged reflected two distinct needs. The constitution of the ACVSB had to meet a need for scientific expertise. The main qualities required of its members would relate to the range of relevant real expertise and acknowledged authority drawn upon. Geographical representation might be uneven. In particular, office holders in territorial BTS organisations would not have been considered for selection in that capacity. Such advisory committees frequently, if not invariably, operate on a UK-wide basis, drawing on expertise from all parts of the UK where that is possible. In contrast, the ACTTD had a more practical focus and had to reflect practices in the constituent parts of the service as a whole. It would be expected that there would be representation of the territorial organisations.

31.440 The ACTTD could not, at its own hand, establish the relationships necessary to ensure the level of collaboration that would have been required to provide fully informed advice to government, taking account of science and the practical transfusion issues that would emerge. As already commented; unfortunately, the terms of reference adopted by the ACTTD at its first meeting cut across the remit of the ACVSB.^[649] The qualification to the ACVSB terms of reference, which was adopted on 4 April 1989, appeared to subject all changes in transfusion practices that would have major implications for other related bodies, to the ACVSB for prior oversight.

31.441 As a practical matter, the potential for discord was real in Scotland, but it appears that it did not have practical effect in England and Wales. Dr Gunson, National Director of the NBTS in England and Wales, was a member of the ACVSB and of the ACTTD, and was in direct contact with the DoH. He also coordinated the work of Regional Transfusion Directors in England in instructing tests on behalf of the ACVSB. In contrast, Professor Cash, National Medical and Scientific Director of the SNBTS and Dr Gunson's equivalent in Scotland, was not a member of the ACVSB. Further, the policy of confidentiality pursued meant that Professor Cash was not fully informed of the thinking of the ACVSB, even when it dealt with transfusion issues relating or potentially relating to Scotland.

31.442 In 1988, the UK Government did not have in place suitable advisory bodies to deal with emerging knowledge of HCV as the means of addressing the risk of infection with the disease in the course of NHS treatment and management. That was the view of Dr Gunson, Dr McClelland and Dr Pickles in the early part of the year. It was also the view of Dr Harris when he addressed the issue in July 1988. His opinion may have involved a particularly narrow view of the skill sets of the members of the EAGA in the context of transfusion medicine. Professor Cash and Dr McClelland especially thought that the EAGA might explore infection-related matters other than AIDS.^[650] Even their view, however, serves to emphasise the lack of an appropriate vehicle for the provision of advice on viral diseases more widely. In the context envisaged by Dr Harris, the view that a new body was required was clearly correct. In principle, the need for a new advisory body was never challenged once it had been articulated by him. Professor Cash's response to the proposal, in July 1988, was to welcome the establishment of a UK group and to comment that he would appreciate, in due course, the opportunity to provide an input with regard to its membership.^[651]

31.443 While departmental responsibility for implementing government policy in relation to health was allocated to the Secretary of State for Scotland, it would not have been an appropriate use of resources to equip the Scottish Office generally, and the Scottish Home and Health Department in particular, with all of the skills required, first to assimilate the advice of advisory and other external bodies and then to advise Scottish Office Ministers independently of the advice available to their colleagues in United Kingdom Departments. The team of Scottish Office officials, medical and administrative, was small, and could not have been expected to act without reference to counterpart teams in the DoH. So far as obtaining advice to inform policy decisions is concerned - ultimately a facet of Cabinet government, collaboration and joint consultation - recognising the superior resources of the DoH is not open to criticism.

31.444 It appears that to avoid budgetary issues and to avoid referring the proposals to Ministers, Dr Harris originally envisaged that the new group would be a working group of the existing NBTS Advisory Committee. What emerged was a properly constituted Advisory Committee, appointed by Ministers to advise Ministers.

31.445 The evidence does not disclose the process by which the change was brought about nor why so much time passed between the new committee first being proposed by Dr Harris in July 1988^[652] and the first meeting of the ACVSB on 4 April 1989. No explanation has been found for the time taken in bringing forward the proposal for Ministers' approval.

31.446 The ACVSB interpreted its remit as relating to matters of major policy. That was reinforced by the committee at its meeting on 24 April 1990. As established, the ACVSB conformed to a well-understood model of an advisory committee, providing government with advice related to policy issues which would in turn be resolved by Ministers. Typically, it was composed of a small core of experts with relevant specialist knowledge and experience, and was attended by representatives of the government departments as observers. It was chaired by the Deputy Chief Medical Officer for England.

31.447 In practical terms, that was reflected in Dr Perry's evidence. He said that the ACVSB was established by UK Ministers to provide expert advice and ensure a uniform approach on blood safety throughout the UK.^[653] The group was considered to be the authoritative source of advice for Health Departments and Ministers.^[654] Representatives of the Health Departments from Scotland, Wales and Northern Ireland attended meetings as observers.^[655]

31.448 There is no reason to doubt that the ACVSB was set up to fill a gap in the advice available to the UK Health Departments on measures required to ensure the virological safety of blood. It has to be noted that a factor contributing to the lack of expert advice on NANB Hepatitis was the premature disbandment of the MRC Working Party on Post Transfusion Hepatitis (of which Dr McClelland was a member) following its second meeting on 25 June 1981.^[656] For a time, the EAGA masked the gap, certainly whilst AIDS was the more pressing problem. There had been a lack of structure in the arrangements for ensuring that the government had properly informed advice in making policy decisions. Establishment of a committee dedicated to consideration of the risk of transmission of viruses by blood and blood products was objectively required.

31.449 The origins of the ACTTD were significantly different. It was not a government sponsored committee. It probably arose from an initiative of Dr Gunson, agreed by SNBTS Directors on 13 December 1988, to form a UK blood transfusion services group on microbiological testing.

31.450 From the outset, Dr McIntyre appears to have seen the establishment of a committee by the Transfusion Directors as a negative development. In his letter of 9 January 1989 to Dr Pickles, he indicated that the Directors' proposals for a committee would be unsatisfactory since 'decisions reached might be influenced to a considerable extent by the views of the Transfusion Directors'. It is not easy to understand what Dr McIntyre meant in expressing his concern that the SHHD might be 'forced into a course of action which might have repercussions for the UK as a whole', though it did emphasise his view that the ACTTD would be a threat to the SHHD and the DoH.^[657]

31.451 Dr Perry had no direct knowledge of the evolution of the two separate groups, but his understanding was that:

[T]he ACTTD was established by the UK Transfusion Services, in the absence of any other suitable mechanism at the time, to coordinate its professional view on the need for additional measures concerning the virological safety of blood and any ... new or revised safety interventions. The original intention ... was that it would provide advice to the Departments of Health either on request or at its own instigation.^[658]

31.452 He commented further in oral evidence that:

[T]ransfusion directors in the UK felt that it would be better if there was a formal process or a committee that could primarily bring together all the expert views on various subjects, but also expecting there to be quite serious and important discussions around surrogate testing.^[659]

The committees' roles in practice

31.453 Hindsight suggests that some of the difficulties that arose between the two committees might have been avoided had the ACVSB been established with a sub-committee, consisting mainly of members with transfusion experience, addressing implementation of policy. Due to their different origins, the terms of reference adopted by the ACTTD at its first meeting on 24 February 1989 cut across the concerns of the ACVSB as they were to emerge. In specifying a role in advising the Departments of Health on policy to be implemented by the UK blood transfusion services for the control of transfusion-transmitted diseases, the terms of reference had the potential to give rise to demarcation disputes. At the first meeting of the ACVSB on 4 April 1989,^[660] the role of the ACTTD was interpreted as covering many of the same issues as the ACVSB, 'but only from a transfusion standpoint', a qualification that in itself had considerable potential for dispute. The second branch of the ACVSB remit was closely related to the operation of the Blood Transfusion Services, and the remit could not be fulfilled without knowledge of the practical implications of advice on scientific matters.

31.454 The respective roles of the two bodies were specifically addressed at the meeting of the ACVSB on 24 April 1990.^[661] As discussed below, while Dr Metters emphasised at that meeting that the ACVSB was concerned with policy and the ACTTD was concerned with operational matters arising from the implementation of policy, the ACVSB does not appear to have always borne that distinction in mind in their deliberations. Dr Gunson's view that there was no conflict between the committees was over-optimistic.

31.455 Dr Perry commented that the ACVSB could not have functioned 'without the ACTTD, without creating an operational group to explore some of the details that it needed to make its decisions'.^[662] From his perspective as a member of the ACVSB, and his knowledge of the workings of the ACTTD, Dr Perry suggested that the ACTTD was more 'action centred' and was more likely to generate work from its meetings. By contrast, if the ACVSB required additional work to be done, it would, in his view commission that through Dr Gunson and the ACTTD.^[663]

31.456 Dr Perry added that the ACTTD brought a 'collegiate expert view from transfusion experts ... with a view ... to advis[ing] departments of health on issues that they thought the Department of Health should be acting on'.^[664] The ACTTD provided Dr Gunson with expert views to transmit to the Department of Health. Dr Gunson was the National Director of the Blood Transfusion Service in England and Wales, and in addition Dr Perry thought Dr Gunson was the expert adviser to the Department of Health.^[665]

31.457 Dr McClelland, who generally had a clear insight into the functioning of the transfusion service, said that it was never clear to him why it was necessary to have two committees. He suspected two groups eventuated because both the DoH and Dr Gunson, the NBTS National Director, wanted to influence decision making.^[666] However, Dr McClelland commented that it was consistent with the remit of the ACVSB to 'cover all the territories' and include observers or participants from the other health departments.^[667]

31.458 Professor Cash commented in his statement that he thought the ACTTD was the 'brain-child' of Dr Gunson who believed it would help him to take the views of a wide group of UK BTS experts to the ACVSB.^[668] Professor Cash commented that Dr Gunson was at times in a difficult position when he thought advice generated by the ACTTD would not be acceptable to the Department of Health.^[669]

31.459 Mr McIntosh commented in oral evidence that it would be too simplistic to classify the ACVSB as dealing with 'policy', and the ACTTD as dealing with 'operations'.^[670]In reality he thought there was some overlap in their work, and there were tensions and some unhappiness between the two committees.

31.460 The ACVSB did not, however, restrict its work to providing independent expert advice to government to assist in formulating policy. It discussed, and took decisions on, operational matters that impacted on the transfusion services. Specific examples have been highlighted in the narrative of the evidence, in particular the instruction of the three-centre comparative trial of the first generation Abbott and Ortho tests, in which the ACVSB appears clearly to have been entering into the 'operational implications of policy' (the function of the ACTTD).^[671] The committee also took account of the implications of funding in its deliberations, instructed by Dr Metters and influenced by Dr Gunson. Dr Metters' understanding of UK Government policy, that there would be no new money for screening and that health boards (at least in England and Wales) would have to find the necessary funds within their existing budgets, was an important consideration for government. But it is not obvious that it should have been a consideration for the experts on the ACVSB. One would have expected them to give independent, objective and scientific advice, and to have left it to the health departments to weigh that advice against its financial implications in the broader context of health policy.

Locus of ACVSB in Scotland

31.461 In the view of Mr Tucker, the SHHD was content to leave the ACVSB to assess whether introducing screening was the right thing to do: it was an expert committee. The SHHD would get a report-back of ACVSB meetings from their observer, Dr McIntyre.^[672] Mr Tucker had been given the opportunity of examining the relevant SHHD file from the time in question and noted that the Minister of State, Mr Forsyth, appeared to be content for action to be taken in Scotland in line with England. He thought all Ministers at that time were part of the same government and would have no desire to break ranks and embarrass other colleagues by taking contradictory action without due cause.^[673] They would want to present a 'united government on an issue like this'.^[674]

31.462 In the opinion of Mr Tucker, as expressed in his statement, it was not unusual for the SHHD to follow the DoH lead on national issues if it was sensible to do so, as the Department of Health had greater resources. He felt that the introduction of national testing was a good example, as it was clear from the expert advice of the ACVSB that bringing in screening was the right thing to do and there was no disagreement in the committee. He said that the SHHD would not necessarily have followed the DoH if England had decided not to introduce screening, but the advice in Scotland had been that testing was worthwhile.^[675]

31.463 This perception within the SHHD that matters could be left in the hands of the DoH, as advised by the ACVSB, implied that the SHHD was not itself required to promote discussion or investigation of an issue such as the introduction of screening, and could await advice from England, with a degree of assurance that it would have the backing of a ministerial decision that the Health Services should stay in line. The SHHD had the advantage, meantime, of information from its observer of the proceedings at the ACVSB, Dr McIntyre. He produced a note of the first ACVSB meeting, which was discussed with Dr Perry in oral evidence.^[676] It was understood that, as an observer, Dr McIntyre could formally provide information from the Department of Health to colleagues in the SHHD. The transfusion services did not have the advantage of direct reporting other than through Dr Mitchell and Dr Perry, but relied on the information being further passed to them by the SHHD.

31.464 Mr McIntosh also said that no-one involved in the management of the SNBTS felt that the ACVSB had any locus in Scotland. The activities of the Advisory Committee in London did not have any effect on his role as general manager of the SNBTS.^[677] He remarked later that the SNBTS had a duty to formulate policy for itself and take it forward, rather than relying on bodies like the ACVSB and the ACTTD with no executive or medico-legal responsibility for the activities of the SNBTS in Scotland.^[678]

Confidentiality of the proceedings of the ACVSB

31.465 Having regard to the whole of the evidence as it developed, it appeared that the most substantial cause of dissatisfaction in Scotland with the ACVSB was not that its role was opaque or difficult to understand. It was that its business was confidential and was not reported in detail to the SNBTS or to the ACTTD. Due to the requirement of confidentiality, as perceived by its Scottish members, the SNBTS general manager and its Medical and Scientific Director were not always informed of the content of debates or decisions at the ACVSB meetings.

31.466 At the first meeting of the ACVSB, the position was made clear by Dr Harris. Members' advice could be publicly sensitive and should not be discussed outside the committee, unless specifically authorised.^[679]

31.467 The perception, therefore, was that confidentiality had to be maintained. Dr Perry told the Inquiry that it was not appropriate for him or Dr Mitchell to return from the committee and brief SNBTS colleagues on the activities of the committee as they were prevented from doing so by confidentiality agreements.^[680]

31.468 Dr McIntyre could formally provide information from the Department of Health to colleagues in the SHHD: the SHHD was among the bodies entitled to receive the advice of the ACVSB. The SHHD could pass information to the SNBTS when it was necessary for individuals to be briefed.^[681] Dr Perry believed that Dr McIntyre was able to relay information to his own department in Scotland, provided that information remained within the Government.^[682]

31.469 As already noted, at its inception, the ACVSB conformed to a well-understood model of an advisory committee providing government with advice related to policy issues. Confidentiality of its proceedings reflected that. Information that Ministers were entitled to accept or reject in formulating policy, in relation to which technical information was one only among a wide range of possible considerations, was inherently sensitive.

31.470 It followed that, as Dr Perry recognised, he and Dr Mitchell were unable to brief colleagues in the SNBTS about ACVSB business.^[683] It followed also, that SNBTS Directors would not have a role in suggesting items for the agenda of the ACVSB, and could not submit briefing papers or have access to minutes of the meetings. Professor Cash's comment to that effect reflected the formal reality of the status of the ACVSB, though he saw it as a deficiency in the arrangements.^[684]

31.471 Dr Perry's view was that the issue of confidentiality was a difficulty for the SNBTS, as policy discussed at the ACVSB often became operational practice and there was concern the SNBTS might be left behind.^[685] He commented that there was '[u]nnecessary secrecy and confidentiality associated with the considerations of the ACVSB and other 'behind the scenes' discussions'.^[686]

31.472 With Dr Perry and Dr Mitchell bound by an obligation of confidentiality and the SNBTS general manager and its Medical and Scientific Director otherwise dependent on the SHHD as an additional source of information, there was some dissatisfaction within the SNBTS about the extent of the information coming from the ACVSB. This was remedied, to some degree, in February 1990 when it was confirmed by Mr Rab Panton of the SHHD that Drs Mitchell and Perry could report the committee's discussions and recommendations to the SNBTS Directors and the ACVSB minutes could be scrutinised and discussed, on an informal basis, at the directors' meetings.

31.473 Professor Cash, as Medical and Scientific Director, remained dissatisfied with the provision of information. He considered it to be patchy and inconsistent. He commented that Dr McIntyre, as the SHHD observer on the ACVSB, told him that he would advise him when he believed there were things he, Professor Cash, should know. He complained about lack of regular briefings and said that the SNBTS Directors got to see the ACVSB minutes only on 'rare occasions'.

How the policy decision on screening was reached - a chronological review

1989

31.474 From the starting point of the UK Ministers' decision on a uniform start date for the introduction of screening, all relevant agencies subscribed to the view that UK blood transfusion services should act in unison. Dr Perry thought it was the accepted view of the ACVSB that testing would be implemented in a coordinated manner across the UK. Professor Cash strongly supported the idea of a common start date.

31.475 In the course of 1989, the NBTS and the SNBTS proceeded with the evaluation of test kits received from Ortho. By the end of August 1989, UK commentators appear to have formed a generally favourable view of the first generation Ortho test. There were still reservations related, for example, to the predictive value of the test in low HCV prevalence populations, such as UK blood donors. Several commentators thought that without a confirmatory test, using an antibody distinct from that used in the initial screening test, there would be serious problems for the blood transfusion services in differentiating between true and false positives. The issues around the specificity and sensitivity of the first generation Ortho HCV ELISA test could not be addressed definitively as part of the evaluations carried out. There were no samples with well established links to NANB Hepatitis available to be tested.

31.476 In September 1989, Dr Gunson and Dr Mitchell had acquired better knowledge of the international scene from the Rome symposium organised by Ortho. In their respective reports for the ACTTD, each expressed concerns about the lack of a confirmatory test.

31.477 At the end of his report,^[687] Dr Gunson asked the ACTTD to approve in principle the routine testing of blood donations for anti-HCV, and to request the National Directors in England and Scotland to arrange for the simultaneous introduction of the tests at an appropriate time when a policy for handling the seropositive donors had been defined. Dr Gunson's report was amended for submission to the fourth meeting of the ACVSB on 6 November 1989.^[688] So far as procedure is concerned, the ACVSB had asked for advice and the ACTTD had approved a report for submission. The ACVSB was asked to approve routine testing for anti-HCV in principle, subject to conditions relating to counselling and management, the availability of a confirmatory test, an FDA licence, and pilot studies of routine use of the test on freshly collected blood.

31.478 At this stage, the blood transfusion services, through the ACTTD, had played their part in recommending the introduction of routine screening in principle. The initiative now lay squarely with the ACVSB. On 6 November 1989, the ACVSB stopped short of approving the introduction of routine testing, in principle or otherwise.^[689] It was decided that three English centres should conduct pilot studies of the feasibility of adding the kits to routine practice. There was no firm intention to recommend screening once the conditions outlined in Dr Gunson's report had been met. The ACVSB appeared unwilling to go further than to offer support for 'general introduction' if the three conditions were met. At this point, that position was not open to objection. The conditions were substantial, and hesitation in recommending positive action was understandable.

1990

31.479 By the time the ACVSB next met, on 17 January 1990,^[690] the FDA had licensed the Ortho product for export,^[691] and the pilot studies had been completed, showing satisfactory test sensitivity and specificity. The emphasis changed. Discussion became more specific in relation to FDA approval for domestic use. The committee had a letter from Professor Zuckerman pointing out that 'considering the overall morbidity of chronic non-A non-B hepatitis ... and litigation which would be indefensible, the introduction of screening could not be delayed much beyond FDA approval'.^[692] So far as the minutes disclose, there was no clear recommendation in favour of testing, even once any remaining regulatory obstacle was removed.^[693] It is also noteworthy that the committee concluded that routine testing should not yet be introduced, whilst also recording an estimate that the annual incidence of NANB Hepatitis in the UK following blood transfusion could be 10,000 cases.^[694]

31.480 It has already been observed (paragraph 31.416, above) that the minute prepared as a result of the ad hoc meeting on 13 September 1991 did not reflect, among other matters, the major concerns about funding in England and Wales that were explicit from at least 7 January 1991^[695] and underlined by Dr Pickles' memorandum of 5 February 1991 (paragraph 31.271, above).^[696]

31.481 Dr Perry's note adds to a general sense of unease that the ACVSB was, at this stage, beginning to be less a helpful provider of relevant and well-directed expert scientific advice to government, and was becoming involved in wider policy issues. However, there was some force in Professor Zuckerman's point that it would be difficult for the ACVSB to approve for use a test that had not passed the regulatory criteria for use in its country of origin.

31.482 There were significant events between 17 January 1990 and the next meeting of the ACVSB on 24 April 1990.^[697] In February, Ortho distributed RIBA test kits for evaluation in the United Kingdom. On 8 February the AABB, the American Red Cross and the Council of Community Blood Centres issued joint guidelines in preparation for the introduction of anti-HCV testing of donations, a clear indication that licensing for domestic use in the near future was anticipated.^[698] Intimation of the guidelines to the DoH 'stirred up a hornet's nest'. Mr Angus' comment that the expression reflected the unexpectedness of the US guidelines appears to be a reasonable interpretation. Professor Zuckerman and Dr Rotblat had both relied heavily on the likelihood of delay at the meeting of the ACVSB in January and Professor Zuckerman had written that the introduction of screening could not be delayed much beyond FDA approval. The unexpected progress towards introduction of screening in the USA went to the roots of ACVSB advice on policy.

31.483 At the ACVSB meeting of 24 April, Dr Mitchell reported on the Abbott symposium he had attended in Chicago and the actions of the AABB immediately following the symposium in directing that anti-HCV testing should be introduced as soon as the FDA approved the test. It was reported that as at 24 April the FDA had not approved the test. The discussion moved to other matters. The idea that the UK could not delay the introduction of screening much beyond FDA approval was not articulated, so far as the minutes disclose. Rather the discussion focused on perceived shortcomings in the test systems available, all of which had been identified in one way or another before January 1990.

31.484 It is appropriate to look at another significant event that had occurred before the meeting of the ACVSB in April: the Ortho symposium held in London in February. There were differing views of it. Professor Zuckerman and Dr Rejman presented adverse reports to the ACVSB. Dr Boulton's report of the symposium to Professor Cash recognised that there were defects in the Ortho test system, but he nevertheless felt strongly that it should be introduced at the earliest opportunity. He was concerned that the SNBTS would face future litigation from people infected with HCV in blood that could have been screened.^[699] At the ACVSB meeting the risk of litigation was mentioned by Dr Mitchell as a factor he had noted at the Abbott symposium, but the minutes do not record any reaction to that.

31.485 A further issue debated on 24 April was the advice to be given to donors.^[700] Since this was a problem inherent in screening from the outset, widely acknowledged and obviously requiring a solution as soon as the possibility of any form of screening was first suggested, it is difficult to understand how it could take on such prominence in ACVSB deliberations at this stage. A solution along those lines did not depend on any insights that could only have been obtained by new information emerging between January and April 1990.

31.486 In reality, the advice of Professor Zuckerman and Dr Rejman, possibly supplemented by the reservations of Dr Mitchell, prevailed. There was no commitment to introducing screening, even subject to FDA approval of the test systems for use in the USA.

31.487 Looking at the record of the proceedings on 24 April, there are several reasons for concern. Papers from the London symposium were produced.^[701] Dr Rejman's notes were brief and one can assume that members of the committee would have informed themselves fully. Professor Thomas had reported on the epidemiology of NANB Hepatitis. In particular, he had reported that most anti-HCV positive patients had mild, frequently sub-clinical, hepatitis after an initial incubation period, but half then made a complete recovery and half progressed to chronic liver disease. A proportion of NANB Hepatitis patients progressed to cirrhosis.

31.488 While the minutes may have provided a less than comprehensive account of discussion, the impression left is that the meeting on 24 April 1990 failed to reflect an appreciation of the seriousness of infection for patients receiving blood, blood components, or products. There was no reference in discussion to Dr Lee's abstract, for example. She had reported that the use of Ortho kits had confirmed anti-HCV sero-positivity in all haemophilia patients with well documented NANB Hepatitis. While there were legitimate reservations about the sensitivity and specificity of the ELISA test at that stage, a balance was necessary that recognised the interests of recipients of human blood in whatever form. The minutes do not provide any comfort that the members of the committee had this in mind or gave it sufficient weight on 24 April 1990.

31.489 Professor Leikola's comment in response to Dr Rejman's observation that the Ortho test was not sensitive or specific enough for reliable testing^[702] was apposite: the tests were considered good enough by the Finnish authorities for screening to have been introduced there in early 1990. Dr Metters had noted at the meeting in April 1990 that France, Belgium, Luxembourg and Italy had all introduced anti-HCV testing. There is a distinct sense that a determination to pursue the best was becoming detrimental to finding a practical and acceptable solution to a real problem affecting the health of significant numbers of NHS patients. Professor Leikola's assessment of the position is accepted. That position can be summarised as follows:

• The Ortho test was not a perfect test at this time.
• The experts contributing to the symposium in London would rightly take a critical approach to the tests, and emphasise what they had found.
• But to conclude on the basis of the information before the symposium that the test should not be introduced was a view he could not take.^[703]

31.490 Professor Leikola found the change of attitude in the ACVSB between January and late April 1990 'remarkable'.^[704] While other countries were largely moving towards a policy of introducing the new tests, the ACVSB's reservations on routine screening had grown in that period. Dr Rejman, a DoH medical officer, had emerged as a contributor to the case against introduction. The next meeting of the committee was scheduled for 24 July, three months later. There was no sense of urgency. The study proposed would require a protocol to be prepared by the sub-committee nominated and then a considerable period to carry it out, whether the target number to be tested was 25,000, 50,000 or 100,000 individuals.

31.491 The contrast between the negative tone of Dr Rejman's comments and Dr Boulton's observations is clear. The evidence concerning the Ortho symposium raises the issue, reflected in Dr Perry's evidence, whether consideration at this meeting of the topic of screening was dominated by reports and discussion from academic virologists.^[705] Dr Perry's view at this time in the process was that the best was becoming the enemy of the good.^[706] In his note to Professor Cash about the meeting he concluded:

[Gunson] and [Perry] felt there was sufficient data to justify testing now (based on U.S data suggesting 50% reduction in PTH) but the majority and the D.O.H. preferred more cautious approach.^[707]

31.492 Drs Gunson, Mitchell, Mortimer and Tedder constituted the study protocol sub-committee to organise the trial. It met on 23 May 1990. By letter dated 5 June 1990, Dr Metters brought forward the meeting of the ACVSB previously scheduled for 24 July.^[708] In the light of 'subsequent events,' namely FDA approval of the ELISA test for use in the USA and 'some additional scientific information' that had become available, an extended study of RIBA and PCR techniques might not be appropriate. The next meeting of the ACVSB would be brought forward to 2 July. The questions to be addressed are set out in paragraph 31.215. They provided for a wide-ranging re-assessment of the approach to screening.

31.493 At the meeting of the ACVSB on 2 July,^[709] the committee concluded that it should recommend to Ministers that testing should be introduced, but that first there should be a pilot study comparing the first generation Ortho and Abbott tests to decide which test was better for RTCs to introduce.

31.494 The papers disclose that there had been additional information on the effectiveness of screening to reduce transmission of HCV infection. The extensive discussion at the previous meeting was not dealt with, and the resolution of the scientific issues then set out - if it occurred - is obscure. The most obvious substantial change was that the FDA had in fact approved the ELISA tests.

31.495 While the decision of the ACVSB in July 1990 to recommend to Ministers that HCV screening should be introduced was policy advice of the kind properly within the remit of that committee, it is less easy to understand why the ACVSB appears to have sought to retain responsibility for deciding which test kit should be used by RTCs. On the face of it, that was very much an operational decision which could have been left to the ACTTD, members of which had long standing practical experience and expertise in evaluating and introducing new screening tests. At that point, however, there does not appear to have been a meeting of the ACTTD scheduled to take place in the then foreseeable future: it did not meet between 16 March 1990 and 8 January 1991.

31.496 It was forecast that four months would be required for the pilot study, after finance had been agreed. At the meeting it was anticipated that the next meeting of the ACVSB would be in October. The date was later amended to 21 November, a date which appears to have allowed for completion of the pilot study. As noted at paragraph 31.233, Dr Gunson reported to the November 1990 meeting of the ACVSB that both the Ortho and Abbott first generation screening tests could be deemed to be satisfactory for routine use within RTCs from an operational viewpoint, and that the results of the supplementary testing would be the decisive factor when considering whether one test was better than the other. In the event, the final report was not available until February 1991.^[710] Had the introduction of screening truly been dependent on the completion of this pilot study, the result of the decision of 2 July would have been that until its completion no decision would have been possible on advice to be given to Ministers as to the preferable test until its completion.

31.497 There were conflicting views before the Inquiry on whether a completed pilot study was required before screening was introduced. Dr Mitchell and Dr Perry, for different reasons, thought that it was. Professor Leikola thought that comparative studies could have been carried out after introduction of screening. Professor Leikola's view appears correct. As it transpired, the study did not add much to the process apart from delay.

Eighth Meeting of the ACVSB

31.498 By the date of the November 1990 meeting of the ACVSB^[711] enough information was available about the pilot study for Dr Gunson to give the information already noted. Equipment would be a factor, but the results of supplementary testing would be decisive in making the choice. After hearing Professor Tedder and Dr Mortimer, the Committee concluded that a combination of RIBA and PCR would provide a useful confirmatory service. Professor Zuckerman observed that, on the results available, it was impossible to choose between the tests. The Committee agreed that it was important to start screening as soon as possible.

31.499 Although there is no reference to a particular date in the minutes, there clearly was discussion of a start date for screening. Dr McIntyre's note^[712] that Dr Metters had proposed 1 April 1991 is accepted as factually correct. Mr Canavan's note to Ministers dated 21 December 1990 indicated that routine screening was unlikely to be possible before 1 April 1991.^[713] That was consistent with discussion of that date by the committee. Dr Mitchell's letter to Professor Cash dated 23 November^[714] was in line with paragraph 10 of the minute. It was on that basis, rather than a precise set date, that Professor Cash contacted RTDs in Scotland to find out when they could begin routine testing. So far as the Inquiry has been able to discover, those who replied could all have commenced screening before 1 April 1991. Subject to the problems that arose later with the Gulf War, meeting that date would not have been a practical problem for RTDs in Scotland. At the November meeting, Dr Metters once more stressed the importance of a common date of introduction of screening throughout the United Kingdom. Since there was no technical or scientific basis for this view, it appears simply to have represented a re-assertion of the continuing policy position of Ministers as understood by the committee.

31.500 In November the ACVSB discussed the counselling of HCV-positive donors. Dr Mitchell advised the committee that the issue had been discussed in Scotland and that a draft document was available which could form the basis of discussion at the meeting of the ACTTD which was to consider the matter. Since the ACTTD was at all times the committee likely to have the responsibility for resolving the practical issues relating to counselling, it is clear that this was a decision that could have been taken at any time over the long period during which the introduction of screening had been discussed by the ACVSB. Had the ACTTD been asked for advice on counselling and failed or delayed in providing it, matters might have been different. But on the evidence available, there was no such failure or delay, and consideration of arrangements for counselling was never a legitimate reason for the ACVSB to delay the provision of scientific advice to Ministers.

The policy of a uniform start date - implementation of screening

31.501 Items 7 and 5 of the series of issues identified by Inquiry Counsel noted at paragraph 31.431, can conveniently be taken together:

The formulation of policy regarding the co-ordination of the starting date for the introduction of screening in Scotland with the starting date for England and Wales, the flexibility of such policy and whether such policy as existed resulted in delay in the introduction of screening in Scotland;

and

Why was there a delay of almost ten months between the decision by ACVSB on 21 November 1990 to recommend the introduction of screening as soon as practicable and the introduction of screening in Scotland on 1 September 1991?^[715]

Uniform start date

31.502 As emerges from the discussion of November 1990, UK Government policy appears to have been static from its earliest articulation down to the end of 1990. Commitment to a unitary start date became almost an article of faith. There is no evidence that the Scottish Office Minister of State with responsibility for Health, or the Secretary of State were ever minuted by officials with a proposal that there should be a different, earlier, start date in Scotland than in the rest of the UK, or that this possibility was ever raised with Scottish Ministers. Without such a step, there was no mechanism by which the political implications of a suggested change of policy could have been addressed and resolved. While that may have been understandable during much of 1990, when it became clear in late 1990/early 1991 that the introduction of testing would be delayed in England, it is a matter of concern, given the public health issues involved, that the matter was not brought to the attention of Ministers in Scotland to consider the earlier introduction of screening.

31.503 There was evidence that the consent of the Secretary of State to a start date of 1 April 1991 was implicit in the approval of the PES for 1991-92. In terms of accountability for public expenditure that was clearly so: the public accounts auditor would have found an appropriate vote authorising the expenditure on screening had it been commenced at any date after the beginning of the financial year. It would, however, be a total fiction to infer detailed knowledge on the part of Scottish Office Ministers of the practical implications and policy background to every line of the PES.

31.504 What is clear is that there was marked reluctance on the part of Scottish officials to bring the question of implementation of screening to the notice of Ministers at all. A full submission was sent to UK Ministers on 21 December 1990.^[716] Mr Canavan's note identified 1 April 1991 as the earliest practicable date. It is not obvious that there was any obstacle to a parallel course being taken in Scotland. Dr McIntyre understood the date to be 1 April 1991. It would have been appropriate for Scottish Office Ministers to have been informed. They were not. If there were good reasons for the delays in presenting a 'Hep C submission' to Scottish Office Ministers during the first half of 1991, they have not become clear in the course of the Inquiry. In the result Mr Forsyth, Minister of State with responsibility for health from September 1990, did not receive a submission until 24 July 1991,^[717] by which time the commencement date of 1 September had been set in stone.

31.505 Scotland's policy had been subordinated to the requirements of England and Wales, effectively the DoH. When Mr Panton wrote to the CSA on 8 August 1991 formally communicating the Minister of State's agreement to testing,^[718] it was too late for any other course to be put to Mr Forsyth. It would, of course, be a matter of pure speculation to suggest any course of action that might have followed an earlier submission that Scotland should commence screening at an earlier date.

Implementation of screening

31.506 The more substantial question is the second: why was there delay from November 1990 to 1 September 1991?

31.507 Dr McIntyre had the impression that the ACVSB had reached a decision that screening should be introduced with effect from 1 April 1991. Dr Mitchell, who had been at the same meeting, thought that the exact date would be 'the earliest practical moment'. That discrepancy is, in itself, indicative of a lack of clarity about implementation. It is also noteworthy that the only steps Dr McIntyre appears to have taken on his return were to report orally to Mr Panton and to prepare a note of the meeting, which was sent to Mr Tucker and copied to the CMO, Mr Panton and Dr Skinner.^[719] According to Professor Cash, Dr McIntyre had previously made the position very clear to him in relation to the ACVSB meetings. Dr McIntyre's position was that he would advise Professor Cash when he believed that there were things Professor Cash should be told.^[720] A decision such as that reported by Dr McIntyre, namely that screening should be introduced from 1 April 1991, would fall within that description.

31.508 As it happened, however, Dr Mitchell informed Professor Cash of the position, although without the specification of 1 April as the date. One could not be critical of the SNBTS response to this news: Professor Cash responded quickly to Dr Mitchell's letter of 23 November 1990^[721] by writing to Directors on 27 November.^[722] There was some uncertainty over the meaning of 'start date', but in the event that had no bearing on any relevant decision required in Scotland. Preparation for donor counselling was put in hand and instructed the ACTTD's thinking on the subject. Again, work in Scotland was ahead of the rest of the United Kingdom and did not adversely affect UK-wide progress towards testing.

31.509 External events affected progress. The Gulf War changed the pattern of demand for blood components, generated a surge in blood donation and for a period into 1991 was an understandable block on progress towards routine screening. But in the early months of 1991, the CSA was on track to deliver funding which would have enabled commencement of screening on 1 April 1991.

31.510 From the beginning of 1991, Professor Cash knew that funding for screening in England and Wales was a problem. He was present at the meeting of the NBTS/SNBTS liaison committee on 7 January 1991, where Dr Gunson explained his concerns about the failure of the DoH to decide on a start date, and indicated that funding was the major problem.^[723] Uncertainty about dates persisted: on 16 January 1991, government commitment was limited to introducing screening 'as soon as is practicable', without a date being indicated.^[724] Lack of funding was related to the UK Government policy position, noted by Dr Metters on 17 January 1990, that 'funding would have to be found from the existing health vote allocation'. The position in Scotland regarding funding was materially different.

31.511 On 21 January 1991, Mr Tucker in the SHHD reported to Mr Panton a conversation he had held with Mr Canavan in the DoH. Mr Tucker had accurately foreseen slippage in timing, and had suggested setting a date of 1 April to prevent all parts of the UK being required to wait for the last area to be ready.^[725] But he viewed this as a suggestion he made to the DoH, rather than as a basis for action by the SHHD to set a date for Scotland.^[726] He regarded the policy of a uniform start date as firmly established; the Scottish Minister 'would not have taken a different course'.^[727]

31.512 Dr Pickles' memorandum dated 5 February 1991,^[728] which was copied only to Dr Metters, Dr Rejman and another official, paints a telling picture of the stage reached at the DoH. It emphasised the practical problems in the way of implementation, and the 'real concern about how the necessary money will get into the system'. Against this background, Dr Gunson's suggestion of a start date of 1 July seemed 'OK', though it would result in some stragglers being left behind. The memorandum was not copied to anyone in the SHHD. It suggests a distinct lack of urgency given the public health issues at stake.

31.513 In Scotland, Professor Cash maintained the commitment to the commencement of screening at the same time in both Scotland and England. On 24 January 1991, he repeated the commitment of the SNBTS to a uniform start date; if pressed he would suggest 'a May/June date'. On 13 February, the SHHD learned from the DoH that it was hoped that screening would commence on 1 July. The SNBTS was specifically identified as a body not to be informed of this.^[729] On 15 February 1991, Professor Cash wrote to Dr Gunson reiterating the SNBTS wish to stay in line with the NBTS/BPL. On the same day, Dr Gunson wrote to regional transfusion directors in England and Wales advising that screening would commence on 1 July 1991.

31.514 The ACVSB met on 25 February 1991.^[730] The need for 'proper' evaluation of the second generation Abbott and Ortho tests was emphasised. It was thought that the kits would 'in principle' be available from 1 July. It was noted that patent rights 'had not yet been determined'. There was no discussion of the problems anticipated. In particular there is no record that members were told that finance was a real concern. So far as the Minute discloses, that remained an internal issue for the DoH, as did the selection of a start date. Those were by this stage properly in the hands of the DoH (at least in so far as England and Wales were concerned).

31.515 In the course of the 'difficult' telephone conversations on 23-24 March, Professor Cash learned from Dr Gunson that there was to be a further postponement. As he described it, only with great difficulty did he support Dr Gunson at the meeting of the ACTTD on 25 March 1991, where the ACTTD accepted the postponement.^[731]

31.516 On 27 March 1991, Professor Cash wrote to Mr McIntosh^[732] and stated that it was clear the NBTS was struggling to meet the 1 July commencement date and that he believed there was a fundamental problem with financial resources. He copied the letter to Dr McIntyre (SHHD), causing concern among the civil servants who had access to it. Why he did not personally speak to the SHHD became an issue for the Inquiry. Professor Cash was asked in oral evidence why he did not confirm the SHHD policy position with them directly. He reiterated that, regrettably, 'Harold Gunson convinced me that SHHD had been party to the decisions that were made'.^[733]

31.517 Professor Cash said that following his letter he spoke to Mr McIntosh, urging him to approach the SHHD and ask whether Scotland needed to continue to 'hang in' with the English dates.^[734] He maintained that at this point he was firmly of the view that an approach needed to be made to the SHHD to consider decoupling the plans for Scotland from those for England and Wales, and expected Mr McIntosh to make the approach, which he would support as National Medical and Scientific Director.^[735] Mr McIntosh did not accept Professor Cash's account of briefing him on the current position in 1991 regarding the introduction of testing and suggesting to Mr McIntosh that he rather than Professor Cash should contact the SHHD.^[736] Professor Cash's account of wanting to see the plans for Scotland proceeding separately from those for England at this point was difficult to reconcile with his evidence that he did not confirm the SHHD position directly because he had been convinced by Dr Gunson that the SHHD was 'party' to the decisions made.

31.518 On his return to complete his evidence, Professor Cash explained that as National Medical and Scientific Director he had to report 'exclusively' to David McIntosh. Mr McIntosh had 'insisted that all communications from the SNBTS ... into the Scottish Office was his job'. Mr McIntosh had support from Jim Donald for this.^[737] He said that he had no direct access, in terms of management line access, into the Scottish Office.

31.519 This was not an entirely convincing explanation: Professor Cash had a long track record of direct communication with the SHHD when he considered that there were issues to address. The conflict in evidence between him and Mr McIntosh - whether Mr McIntosh was asked to take the initiative - casts doubt over the sequence of events. But it appears to be clear that no approach was made to the SHHD to re-consider a phased introduction of testing across the United Kingdom, rather than the existing ministerial commitment to unified action, in order to avoid the further postponement of screening beyond 1 July 1991.

31.520 If issues concerning the introduction of screening were indeed matters of management, it would be difficult to reconcile that with Professor Cash's communications with Dr Gunson over the issue. The question concerns Professor Cash's role as National Medical and Scientific Director. From at least 5 June 1990 he had special responsibility for operational quality, and for research and development, and he was charged with convening and chairing the Medical and Scientific Committee of the SNBTS (MSC).^[738] The MSC remit was professional and scientific matters. In contrast, the SNBTS Management Board was the body through which all key policy and strategic decisions were to be channelled.^[739]

31.521 The introduction of screening clearly involved professional and scientific matters within the remit of the MSC, as well as policy and strategic matters within the remit of the SNBTS Management Board. The selection of a start date would have required advice on technical feasibility. Funding would have been a matter of policy on which the SNBTS Management Board might offer views, but it would then have been for the SHHD and Ministers to take a policy decision. On no view of Professor Cash's role as National Medical and Scientific Director was he entitled to negotiate and conclude an agreement with Dr Gunson as to Scottish, much less UK, policy on the date for the introduction of screening, without reference to the MSC and the SHHD. That this is what happened is supported by the contemporaneous documentation; as the submission for the Scottish Government observed, there is no evidence from 1991 to support the suggestion that Professor Cash was in favour of a reconsideration of the policy of a common UK start date, and much that is against it.^[740]

31.522 Even on Professor Cash's account of events, direct discussions between him and Dr Gunson (who did not, in the opinion of Mr McIntosh, have executive authority for the NBTS)^[741] had illustrated the vague nature of policy making for Scotland in relation to the introduction of screening. The manuscript note on the SHHD copy of Professor Cash's letter to Mr McIntosh dated 27 March 1991, implies that officials did not know until that point of the further postponement of the introduction of screening.^[742]

31.523 Formally, it was open to Scottish Office officials at any time to make a submission to the appropriate Minister, and onwards to the Secretary of State for Scotland, that the commitment to a uniform UK start date for the introduction of any form of screening, but specifically anti-HCV, should be withdrawn and that screening should be introduced in Scotland when the SNBTS regions were equipped, funded and fully prepared to implement the decision. It would have become a political issue for Scottish Office Ministers in the first instance, and no doubt thereafter for discussion with UK Departments, whether to make a change of direction.

31.524 This is precisely what was to happen at the end of 1994 in respect of Hepatitis C look-back. Lord Fraser of Carmyllie, then Minister for Home Affairs and Health at the Scottish Office, was advised that the SNBTS was ready to proceed with look-back and that, on medical and legal advice, the Secretary of State and he had a duty to initiate the process notwithstanding earlier UK policy.^[743] In the result, UK policy was changed. However, the obligation of Scottish Ministers to act independently of UK colleagues where Scottish health issues were concerned, was asserted unequivocally.

31.525 In the end, problems of funding the NBTS in England and Wales to start screening pushed the start date for the UK back to 1 September 1991. Mr McIntosh's assessment of the position is accepted. The successive delays over the period March to September 1991 were exclusively a direct result of giving priority to the UK solidarity argument. That was underlined by the financial problems in England and Wales.

31.526 The 'device' of presenting the implementation in Glasgow - along with Newcastle and two other centres - as a further study, was related to Newcastle's decision to take unilateral action. As a practical matter, the result was that for half of Scotland agreement on a UK-wide start date ceased to matter. In Edinburgh, testing began on 30 July 1991.^[744] For the remaining parts of Scotland, UK solidarity may have been a significant disadvantage. In this regard, however, it has been pointed out to the Inquiry that in Dundee, contemporaneous documents suggest that assessment of, and familiarisation with, testing kits began in the middle of July, with all units producing other than negative results being withheld from issue.

Summary and conclusions

31.527 It is now necessary to try to draw the material together. The topic addressed in this chapter is conveniently viewed in two parts. First, there is the period between the summer of 1988 when the establishment of the ACVSB was first mooted, until the committee decided to recommend the introduction of screening for Hepatitis C on 21 November 1990. Secondly, there is the period after that decision when implementation was arranged, with screening finally starting across the UK on 1 September 1991. The Inquiry does not have enough information to be critical of the composition of the ACVSB, or to assess the dynamics of particular meetings. All those appointed were experts in their respective fields and there is nothing to suggest that they acted other than in good faith at all times. There is therefore no basis on which individual members of the committee or officials in attendance can be criticised in relation to the workings of the committee, and no observation made or conclusion reached by the Inquiry should be understood as making any such criticism.

31.528 Reverting to the questions posed at the conclusion of the Inquiry,^[745] the first three of those questions concern the construction of processes for reaching a decision about introducing screening, and implementing any decision to proceed. It is therefore appropriate to consider these matters together.

1. Until the establishment of the ACVSB, the UK did not have in place an appropriate mechanism for providing Ministers with independent scientific advice on the risks presented to NHS patients by transmission of viruses in blood, blood components and blood products. The decision to establish the ACVSB was therefore well founded.

2. The emergence of two committees - one established by the DoH in consultation with the other health departments of the UK and one established by the transfusion services - created a risk of confusion as to the respective remits of each and the relationship between them. The formation of the ACTTD appears to have been due to a perception on the part of Dr Gunson and Professor Cash that nothing had happened to progress matters, after the creation of a government committee had been mooted by Dr Harris in July 1988.

3. In retrospect, a better model would have provided for advice as to policy and arrangements for implementation to be coordinated, for example by the establishment of an ACVSB with a sub-committee, consisting mainly of members with transfusion expertise, to address the implementation of policy. Thus, what Dr Perry termed 'scenario planning' could have been addressed in a dedicated forum whilst policy was being finalised by the ACVSB.

4. There was a lack of clarity as to how there was to be implementation in Scotland of decisions reached by the committees. There was asymmetry in that the Director of the NBTS, Dr Gunson, served on the ACVSB whereas his equivalent in Scotland, Professor Cash, did not. The requirement of confidentiality relating to the proceedings of the ACVSB, coupled with a lack of routine communication back to the SNBTS, contributed to the perception in Scotland that there was little direct involvement in decision making. That said, it is not clear that the deliberations of the committee would have been influenced by additional Scottish representation, and it is clear that when the decision to recommend the introduction of screening was finally made by the ACVSB in November 1990, Scottish centres were well placed promptly to implement the decision.

31.529 The fourth question posed related to factors which contributed to there being no decision until November 1990 to recommend to Ministers that screening should start as soon as practicable:

5. From around the end of 1989, the ACVSB became involved in more than expert scientific advice; the committee was considering wider policy issues and addressing the practical implementation of policy.

6. In retrospect, the meetings of the ACVSB on 24 April and 2 July 1990 were missed opportunities to recommend the earlier implementation of screening.

a) At the meeting on 24 April 1990, the committee was presented with a particular impression of the symposium held by Ortho in London in February. That impression appears to have influenced the committee against the test. Dr Boulton, Deputy Director of Edinburgh and South East Scotland BTS, had also attended the seminar, and reported on it to Professor Cash. The Inquiry considers that Dr Boulton more accurately identified and weighed the relevant considerations in suggesting to Professor Cash that screening should be introduced at the earliest opportunity than did the members of the ACVSB at their meeting of 24 April.

b) It had been pointed out by Professor Zuckerman at the beginning of 1990 that the introduction of screening could not be delayed much beyond FDA approval of the test, but it appears that the committee was taken by surprise by news that approval had been granted on 2 May 1990. When that occurred, as Burton J pointed out in A v National Blood Authority, it completed the three requirements set out in the minutes of the ACVSB meeting of 6 November 1989: successful pilot trials in the UK, the grant of FDA approval and the existence of a RIBA supplementary test (albeit not strictly a confirmatory test).^[746] An inference that FDA approval was imminent could have been drawn: an export permit had been granted in the USA in November 1989 and guidelines for testing had been issued there in February 1990.

c) The decision at the meeting on 2 July 1990 to delay implementation until the completion of a further trial - this time to compare the Ortho and Abbott tests - was not warranted in the circumstances; local centres could have made their own choices and comparisons of the kits could have been made once screening had started.

7. In all the circumstances, a decision to recommend to Ministers the introduction of routine screening of blood donations for anti-HCV could and should have been taken by the middle of May 1990. It appears unlikely; however, that screening in any centre could have started much before the autumn of 1990. Having regard to the supplies of test kits available.

31.530 The remaining questions concern the period after the decision to recommend the introduction of screening. The Inquiry has endeavoured to assess why there was a delay of almost 10 months between the decision by the ACVSB on 21 November 1990 to recommend the introduction of screening as soon as practicable and 1 September 1991, the point from which donations across Scotland were all being screened. It has also analysed the original policy that introduction of screening should take place at the same time across the UK, and considered if involvement of the Scottish Health Minister earlier than July 1991 would have led to earlier introduction of screening.

8. It is relatively straightforward to explain as a matter of fact why the time elapsed. There was a delay of almost ten months because a policy set at the outset - that the introduction of screening across the UK should take place at the same time - was maintained despite some areas being ready to begin considerably earlier than others.

9. It is much less straightforward to explain why there was no deviation from this policy. The period 21 November 1990 to 12 June 1991 included a number of missed opportunities for more prompt introduction of screening in Scotland.

• In the first place, if Dr McIntyre had communicated to Professor Cash his understanding that the date for introduction of screening was to be 1 April 1991, the efforts of the SNBTS would have been directed towards achieving that implementation date.
• In the second place, if Mr Tucker had been less diffident in communicating his perception in January 1991 that 'to delay for the slowest could mean a long wait', there would have been an opportunity for the date of 1 April to be confirmed as the date for introduction of screening in Scotland.
• In the third place, if Dr Pickles had copied her memorandum of 5 February 1991 to any officials in the SHHD, it would have been appreciated more clearly that the funding problems in England and Wales were delaying the introduction of screening in Scotland.
• In the fourth place, if the SNBTS, especially Professor Cash, and Mr McIntosh had explained the situation fully to the SHHD at the end of March 1991, and had put to them the suggestion that Scotland was in a position to move ahead with the introduction of screening in July 1991 as previously intended, a decision to adhere to that start date could have been taken. Instead, Professor Cash in effect determined the policy for Scotland, by agreeing with Dr Gunson a postponement of the introduction of screening to 1 September 1991, to be ascribed to the need for evaluation of second generation test kits.

10. Any suggestion that taking one or more of these steps would have led to earlier introduction of screening involves a determination that the position of the responsible Minister in Scotland would have permitted different dates for the introduction of screening in Scotland and in England/Wales. It is not possible to make such a determination. Viewed now, the reluctance to bring the issue of when screening was to start in Scotland to the attention of Ministers seems odd; the proposition that authorisation of the setting of a date could not be sought until a date had been determined elsewhere appears surprisingly passive. It may be that officials took for granted that there would be no change in direction. But within Scotland, the ultimate responsibility for the safety of patients undergoing NHS treatment with blood and blood products was that of the Secretary of State and his Ministers. Serious problems in relation to the introduction of a measure which would improve that safety should have been communicated to them, in order that they could decide what should be done.

32. An Investigation into the Systems in Place for Informing Patients about the Risks - Ethical Context >