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Dr Mortimer reported on developments in the pilot study, now comparing two further candidate screening tests, from Wellcome and UBI, with results from the Ortho and Abbott test kits.

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In a minute to Scotland's Deputy Chief Medical Officer Dr Young, Dr McIntyre stated: "Things are moving very fast on the Hepatitis C front" and he anticipated that at the next Advisory Committee on the Virological Safety of Blood meeting it would be decided that "there is no alternative but to recommend the introduction of the test."

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It was reported in "Blood Bank Week" that Chiron Corporation hoped to have their test to screen blood for non-A non-B Hepatitis available for clinical trials by the end of the year.

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Dr Gunson produced a paper reporting on the use of the RIBA II confirmatory assay to assess reactive results from the first-generation Ortho and Abbott study.

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Dr Gunson wrote to regional transfusion directors enclosing an updated report on the comparison study of Abbott and Ortho anti-HCV test kits whilst noting that the study of the new generation tests was proceeding.

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Professor Tedder tabled a paper on the new generation Abbott and Ortho tests to be discussed at the ninth ACVSB meeting.

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In "A and Others v National Blood Authority" Mr Justice Burton heard evidence from Dr Harold Gunson, who had been director of the National Blood Transfusion Service and Dr (now Professor) John Barbara, lead scientist in transfusion microbiology at the North London Blood Transfusion Centre at the relevant time, amongst other key factual and expert witnesses.

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It was generally accepted - and Dr Gunson believed - that the incidence of non-A non-B Hepatitis in the UK was 3%.

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The incidence of non-A non-B Hepatitis in the US was 7-12%.

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At the time that the responsible minister was being informed that there was insufficient information to enable a decision to be taken, Australia was introducing routine screening, France was about to introduce it, and it had been in place in Japan since November.

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Professor Zuckerman explained in the "A and Others v National Blood Authority" litigation that he meant that the RIBA test was not genuinely a confirmatory test because it also tested for the antibody, rather than a comment on its unreliability as such.

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By 1985, Professor Zuckerman spoke of a specific test for non-A non-B Hepatitis being "awaited with breathless anticipation", thereby conveying both the importance of developing such a test and the urgency of doing so.

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Dr Alter concluded that "the discovery of [Hepatitis C] is a fundamental breakthrough in virology" and went on to urge that the Ortho assay should immediately be implemented for donor screening once licensed.

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Dr Barbara returned from a symposium in Paris, organised by Ortho, with a positive reaction reporting that the test seemed "reproducible, robust and meaningful".

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During the hearing of "A and Others v National Blood Authority", leading counsel for the National Blood Authority expressly accepted in relation to surrogate screening that cost should not be a determining factor and did not suggest that it should be a factor in considering routine screening.

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In "A and Others v National Blood Authority", Mr Justice Burton highlighted Dr Gunson's evidence, where he said in concluding part of his decision: "I have already referred to Dr Gunson's evidence, subject to the question of a confirmatory assay as to 'certainly early in 1990', in retrospect. Later in cross-examination, he said...I have now said three times - I think I did say to His Lordship yesterday - that in retrospect we should have done it a different way.'"

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After the FDA had granted a licence for the Ortho test, anti-HCV screening was still not introduced.

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In "A and Others v National Blood Authority" Mr Justice Burton said he was satisfied that the basic requirements for implementing routine screening 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.

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Mr Justice Burton in "A and Others v National Blood Authority" recorded that "Dr Gunson accepted that, in retrospect, the fact that no preplanning was done for a year was obviously not satisfactory. Had there been counselling procedures in place, it appears to me that the system might have been able to cope, albeit with difficulty, as the West Midlands Report had indicated in December 1989, even without the confirmatory test".

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Ortho organised a second Hepatitis C Symposium in London.

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