THE PENROSE INQUIRY
Final Report

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Chapter 26

Donor Selection - Higher Risk Donors

Introduction

26.1 This chapter sets out donor selection policies and practice in the 1970s and early 1980s relating to the acceptance of blood from particular groups of donors who, either at the time or with the benefit of hindsight, might be considered to present a higher risk of transmitting hepatitis viruses than the general population. The main groups under discussion in the chapter are intravenous drug users and prisoners. Military personnel from the USA are also discussed.

Intravenous drug use

26.2 Intravenous drug users (IVDUs) presenting at ordinary SNBTS public sessions as prospective donors would be received, interviewed and observed as would any other member of the general public. The prospects of their identification as IVDUs would be related to general practice at interview and observation of the prospective donor, as discussed in Chapter 18, Collection of Blood - General. In relation to prospective donors who used or were suspected of using intravenous drugs, particular questions arise in the case of those detained in penal institutions. That topic is discussed later in this chapter.

26.3 It was a feature of the evidence about donor selection from the earliest years of the reference period that a recent or current history of injecting drugs, or physical evidence of having injected drugs, was seen as a ground for exclusion. Whether the prospective donor would have been asked about drug use was a different matter, however. As noted in Chapter 18, Collection of Blood - General, there was relatively little face-to-face questioning of donors presenting at sessions. Intravenous drug use was not necessarily one of the features drawn to the prospective donor's attention as affecting their suitability as a donor. Dr Brian McClelland, who joined the Edinburgh and South East of Scotland Blood Transfusion Service (BTS) as a Consultant in 1977 and became Regional Director in 1979, thought that the majority of staff would have asked about drugs, but he could not be sure that it happened in the period before routine questioning of the donor was instituted in his area in 1982 or 1983.^[1]

26.4 A new comprehensive guide was prepared at that time, in response to the observations of the Medicines Inspectorate, for use in the Edinburgh and South East of Scotland BTS. The copy of the guide recovered by the Inquiry is only partly legible. In relation to drug use, however, the guide advised SNBTS staff to consult the doctor or sister on duty. As general guidance, it stated:

At least 6 months should elapse after the use of parenteral drugs because of the risk of serum-hepatitis.

Donors under the influence of oral drugs should not be accepted.

In both cases, bear in mind the possibility that the history given by these donors regarding the abuse of drugs may be unreliable.^[2]

26.5 Temporary deferment of IVDUs appears to reflect a view that a six-month deferment period was sufficient for Hepatitis B to have become detectable on screening. On the copy available to the Inquiry is a manuscript note: 'International policy'.^[3] Such a policy, however, would not have excluded donors who had become infected with non-A, non-B Hepatitis (NANB Hepatitis) as a result of injecting drug use.

26.6 So far as Glasgow and the west of Scotland was concerned, the evidence of Mrs Rosalind Prior, who was employed by the SNBTS as a Mobile Team Assistant in the region between 1969 and March 1974, was that in the early 1970s staff were never told to ask any donors if they had ever used intravenous drugs.^[4] Dr Ruthven Mitchell, Director of the Glasgow and the West of Scotland BTS from 1978 to 1995, stated that:

Throughout the life of the UK transfusion services, it was always thought that donors were selected on the basis of 'tinker, tailor, soldier, sailor, rich man, poor man, beggar man, thief', great efforts are made to avoid any discrimination.^[5]

26.7 He was, however, quite clear that known drug addicts were not to be bled as donors.^[6]

26.8 In international guidance, an association between intravenous drug use and transmission of Hepatitis B was noted before the beginning of the reference period. The 1971 World Health Organization (WHO) Guide to the Formation and Operation of a Transfusion Service^[7] stated that, during the physical examination of the blood donor, 'the medical officer should be able to pick out those prospective donors who may be, for example ... drug addicts'.^[8] Dr McClelland's evidence was that the interview routine was supplemented by observation.^[9] A matter of interest for SNBTS staff would be whether, when the donor's arm was exposed to take a sample, evidence of needle injection tracks might be disclosed. It is not clear to what extent a 'physical examination' was carried out in the first half of the 1970s, however. Mrs Prior's account of the procedure in her area does not mention what the doctor in attendance at donor sessions did routinely.

26.9 Relying on such observation as was possible in those circumstances, was never likely to expose all prospective donors who might transmit viral infection. Needle track marks on the lower arm of a person currently using drugs by injection might or might not have been identified during the process of taking a blood sample while evidence of injection elsewhere on the body would not. As was to be recognised at least by 1987,^[10] the problem was related to the risk of parenteral transmission at any time during the individual's life: injection of controlled drugs might have ceased long before the donor session or might have been a single act of an individual otherwise free from the use of illicit drugs.

26.10 In the United Kingdom, the problem of drug use was dealt with under the Misuse of Drugs Act 1972, in which the range of offences recognised both the use and supply of controlled drugs as social problems that required to be addressed. On the evidence before the Inquiry, it appears that drug use was not recognised as a problem in prisons until later in the reference period. In transfusion practice in the USA, intravenous drug was probably initially a problem, reducing somewhat as paid donation reduced and then ceased. There was a tendency, however, for paid donors, drug addicts and other disadvantaged members of society to be grouped together by commentators.

26.11 Since the establishment of the Scottish National Blood Transfusion Association (SNBTA) in 1940, paid donation had not been a practical issue in Scotland, so far as transfusion and the manufacture of NHS blood products were concerned.^[11] In other respects, however, Scotland experienced a similar range of problems.

26.12 In 1973 the WHO published a report of a meeting of an expert scientific group on viral hepatitis.^[12] In a section on 'Changing patterns of infection in certain developed countries', the report commented on an increasingly large proportion of cases of Hepatitis B infection, particularly among males in the 15-29 year age group, suggesting a likely association with the illicit use of drugs.^[13]

26.13 In December 1975 a World in Action television programme, 'Blood Money', was broadcast in the UK. The programme was about the risk of transmission of hepatitis from blood products manufactured by US commercial companies using blood taken from high-risk paid donors.^[14] Professor Arie Zuckerman, who was to play a central role in developing policy advice on blood transfusion in the UK, was quoted in the programme:

Well it's been recognised for a number of years now that bought blood does carry a higher risk. And it's difficult to actually pinpoint the reason, but it seems that individuals who are willing to sell their blood are normally from a background which appears to be rather poor socio-economically.

In the past, many of them were alcoholics and indeed the well known dictum which originated in the United States was Ooze for Booze. This has recently been replaced by perhaps a more serious element, namely drug addicts.^[15]

26.14 Two US researchers, Dr Harvey Alter and Dr Leonard Seeff, commenting on commercial blood collection, noted that:

Prior to the advent of hepatitis serological assays, by far the most important hepatitis risk factor identified was the origin of the donor blood.^[16]

26.15 By 1975, when Professor Zuckerman made his observation that 'bought blood does carry a higher risk', the broad group of individuals thought to present risk had not changed. Risk was associated with poor, socio-economically disadvantaged people but the characteristic behaviour that was the subject of comment had moved from alcohol to drug use.

26.16 The move away from collecting blood from paid donors began in the USA in the early 1970s as a result of the higher incidence of post-transfusion hepatitis associated with such donations. In 1974, Alfred Prince and others reported that, in their series of investigations, the risk of non-B Hepatitis was 10 times higher among recipients of blood obtained from commercial sources than among those given blood from volunteer donors.^[17]

26.17 It appears that, as paid donation in the USA was phased out, there was greater emphasis on identifying donor groups that presented increased risk of transmission of infection by reason of their behaviour. In a paper published in February 1976 on 'Blood Transfusion and Transmissible Disease', Dr John Wallace, at that time Director of the Glasgow and the West of Scotland BTS, noted that, '[g]roups known to have a high prevalence of antigenaemia [a high prevalence of Hepatitis B antigen] include immigrants or returned travellers from tropical areas, drug addicts, male homosexuals, prisoners, the tattooed and the sexually promiscuous'.^[18] Although Scotland did not have an issue with paid donation, parts of the country, and in particular Edinburgh, came to be associated with serious drug use and there was increasing emphasis on excluding those using intravenous drugs from donation.

26.18 The International Society of Blood Transfusion (ISBT) Guide Criteria for the selection of blood donors published in 1976,^[19] in a section on viral hepatitis, listed groups of prospective donors who should be excluded from donating blood. The list included those 'suspected to be parenteral drug addicts'.^[20] The use of the present tense 'to be' may suggest a focus on current, or at least recent, drug use. In addition, in a section on medication and drugs, the document stated:

Those who admit to occasional use of marijuana, LSD, and similar hallucinatory drugs may be accepted if they have not taken any in the previous 72 hours and their arms show no signs of needle-puncture marks or scars indicating that they might have been taking drugs parenterally. Regular users of hallucinatory drugs may, however, be unable to give an accurate history with regard to injectable narcotics or exposure to hepatitis; for this reason they should be disqualified.^[21]

26.19 Dr McClelland received the ISBT documents but did not know whether this guidance influenced thought and practice in Scotland at the time.^[22] His general evidence, however, was that evidence of drug use disqualified potential donors.

26.20 From 1974, the CSA had the duty of providing blood supplies for transfusion and for the production of blood fractions. However, the Regional Transfusion Centres remained largely autonomous entities as far as many professional matters were concerned. The SNBTS stated that, in respect of blood donor selection, the Regional Transfusion Director (RTD) and his/her consultant colleagues determined their own local policies and issued guidance to medical and nursing staff.^[23] From 1977 to about 1982, when the SESBTS produced their own guidance, all RTDs used the Memorandum on the Selection, Medical Examination and Care of Blood Donors prepared on behalf of the NBTS in 1977 and amended in 1983, 1985 and 1987 for guidance. In 1985, it was agreed that the SNBTS should prepare guidance for Scotland based on the SESBTS documents. The 1977 version of the NBTS Memorandum stated that 'illicit drug taking if suspected or admitted should debar'.^[24] That wording persisted in the 1983 version of the same memorandum but, in addition, under the section on 'Medical History' the document indicated in relation to 'Drug Abuse' that disqualification should occur.^[25] The 1987 edition advised staff who might be concerned that a potential drug user had presented as a donor to consult the sister or doctor and stated: 'Anyone who has ever injected drugs to be deferred permanently'.^[26]

26.21 The express recognition in 1987 that risk may have been created in the past as much as by current IVDU was a significant change of emphasis. The 1979 edition of the Department for Health and Social Security (DHSS) Standards for the Collection and Processing of Blood and Blood Components and the Manufacture of Associated Sterile Fluids, applicable throughout the United Kingdom, had stated that '[i]llicit drug taking' would 'disqualify a person from acting as a donor'.^[27] As in the 1977 edition of the NBTS Memorandum on the Selection, Medical Examination and Care of Blood Donors, the question whether the prospective donor had ever taken drugs was not expressly addressed at that time.

26.22 The ISBT guidance of 1976, that suspected drug addicts should be excluded from donating blood, was not universally followed. The response by the Edinburgh and South East of Scotland BTS to a report of the Medicines Inspectorate, published in January 1983, noted that, as a routine for all donors, a detailed health check questionnaire had been introduced.^[28] The questionnaire did not, however, ask if the donor had a current or recent history of intravenous drug use, far less if they had ever injected drugs.^[29] In addition, as noted in paragraphs 26.4 above, guidance on donor selection made available to staff in the Edinburgh and South East of Scotland BTS at that time, was to the effect that a history of intravenous drug use did not result in indefinite deferral but instead resulted in deferral for a period of at least six months, 'because of the risk of serum-hepatitis'. However, in response to AIDS in 1983 a leaflet, 'AIDS and Blood Transfusion' issued by the Edinburgh and South East of Scotland BTS, included IVDUs among those at risk of contracting AIDS and asked them to avoid giving blood until a screening test was available.^[30]

26.23 A donor leaflet apparently in use by the Glasgow and West of Scotland BTS in 1983 listed a number of matters to be reported by prospective donors to the doctor in charge of the session.^[31] It asked whether the donor had experienced a serious illness such as jaundice. Again, the leaflet did not ask whether the donor had a current or recent history of intravenous drug use or if they had ever injected drugs, nor were those questions contained in a donor leaflet seemingly in use in England and Wales in 1983.^[32] In this respect the Glasgow and West of Scotland leaflet was consistent with Mrs Prior's evidence about practice in the west of Scotland during the 1970s.

26.24 In his evidence to the Inquiry, Dr McClelland stated that he could only be confident that the majority of staff would have asked donors about current or past drug use only from the early 1980s, when there was an awareness of AIDS.^[33] Dr Mitchell was asked whether, in the late 1970s and early 1980s, it was the practice at donor sessions to ask donors if they had ever injected drugs. He replied, 'I think - no, I don't think so in the 1970s. I can't remember it being there. It might have been later in the consideration of AIDS'.^[34] Professor John Cash, Medical Director of the SNBTS during much of the reference period, did not know whether donors were asked whether they had ever injected drugs but said, 'my gut feeling is certainly when we got into the area of AIDS, there was great difficulty for some of our staff asking very straight questions about people's lifestyles'.^[35]

26.25 Prior to the advent of AIDS, therefore, evidence of current or recent intravenous drug use, whether in the prospective donor's response to enquiry or by observation, had been recognised in published statements as a ground for exclusion for a considerable period. However, before the advent of AIDS there appears to have been no direct questioning of donors in relation to any recent or current history of intravenous drug use. Evidence of use of intravenous injection of drugs at any time in the past was beginning to be recognised as a ground for exclusion only in the later 1980s, as it came to be understood that NANB Hepatitis viraemia might persist indefinitely. Prior to the advent of AIDS reliance was placed on observation and donor responses to questionnaires.

Prison collections

International guidance

26.26 There was limited guidance in international literature on the practice of collecting blood in penal institutions. The 1971 Guide to the Formation and Operation of a Transfusion Service, already mentioned in paragraph 26.8 above, recommended that countries setting up a donor recruitment scheme should take initial steps to form panels of donors within groups such as the armed forces, the police, large industrial or commercial undertakings, universities, prisons and social or religious foundations.^[36] Since it was aimed at those with the responsibility of establishing and developing transfusion services in their own countries, it focused on the effectiveness of management of the new services rather than on specific risks.

26.27 In defining preferential sources of blood, the aim of the 1971 Guide was to facilitate the early stages of development of a service where none had previously existed and the reference to the collection of blood from prisons has to be seen in that context. In addition, the Guide was written before, or at least around the same time as, evidence began to become available in the UK that prison donors had a higher prevalence of 'Australia antigen' (the early name for the Hepatitis B surface antigen, HBsAg) than non-prisoner donors. This is discussed more fully in Chapter 15, Knowledge of Viral Hepatitis 2 - 1975 to 1985. Having regard to these factors, it is not possible to rely on the recommendation in the Guide to form donor panels in prisons in drawing particular inferences about practice in Scotland.

26.28 The ISBT Criteria for the Selection of Blood Donors proposed in 1976 that prospective donors should be excluded if they were 'inmates of a correctional institution'.^[37] As noted in paragraph 26.19, Dr McClelland did not know whether the ISBT guidance influenced thought in Scotland in the late 1970s and early 1980s.

26.29 In 1978 the WHO Expert Committee on Biological Standardization published a report.^[38] The report noted that it had been agreed that it would be useful to have a single set of requirements applicable to all organisations and laboratories involved in the collection of blood for fractionation and for blood products. It also set out a range of proposals in an Annex on Requirements for the Collection, Processing and Quality Control of Human Blood and Blood Products.^[39] In respect of individuals who might fall within proscribed groups, the report stated:

Donors shall have a negative history of viral hepatitis, of close contact with an individual with hepatitis within six months, of receipt within six months of human blood or any blood component or fraction that might be a source of transmission of viral hepatitis, or of tattooing within six months.

....

Donor populations showing a prevalence of acute or chronic hepatitis higher than that found in the general population should be avoided for collection both of single donor products (whole blood and its components) and of plasma for pooling for the manufacture of plasma fractions known to be capable of transmitting hepatitis, such as clotting factor concentrates.^[40]

26.30 As regards the last recommendation quoted, Professor Juhani Leikola of the Finnish Red Cross Blood Transfusion Service stated in his evidence to the Inquiry that he would not place much weight on a recommendation relating to the avoidance of a donor population showing 'a higher prevalence of acute or chronic hepatitis than in the general population'. He explained that this is because (i) direct markers of disease (eg the presence of antigen) should be used when identifying a group with a higher prevalence of disease, rather than indirect markers such as 'acute or chronic hepatitis' and (ii) the recommendation does not say how much higher the prevalence of disease should be in a donor group for that group to be excluded. He also commented that the committee that produced the recommendation comprised biologists, virologists and fractionators rather than those with practical experience of blood collection or transfusion.^[41] Subject to those reservations, which are accepted to be valid, the last paragraph would have applied to prison donor populations in Scotland in the later 1970s when data on the prevalence of HBsAg in prison populations became available.^[42] Prison populations as such were not, however, targeted.

26.31 None of the Scottish or UK guidance documents on the selection of donors contained any reference to the collection of blood from prisons or young offenders' institutions at this period. Reservations about collections from prisoners were expressed in the Annual Report of the Edinburgh and South East of Scotland BTS for 1973-74, which included an address given by Professor Anthony Ritchie, Chairman of the Central Consultative Committee of the SNBTS.^[43] He contrasted donations of blood drawn from prisoners, where 'there is little enough "voluntary" aspect to donation', with the general British system in which virtually all blood donors were true volunteers.^[44] There is no evidence that his views influenced practice at that time, however.

26.32 The SNBTS Regional Directors were aware of the NBTS Memorandum on the Selection, Medical Examination and Care of Blood Donors and there was evidence that the RTDs based their donor selection policies on that document.^[45] However, in this, as in other matters, the individual Transfusion Directors will have exercised their own discretion in the manner in which they did so. They had a high degree of autonomy in donor selection and it is not possible to state that there was uniform practice.

International practice

26.33 Reaction against collection in prisons started early in the 1970s in the United States of America. Professor Richard Titmuss' book The Gift Relationship had a powerful impact.^[46] When he published, in 1970, it was well-established in the USA that there was a relatively high prevalence of serum hepatitis among certain donor populations and, in particular, among the 'cloistered residents of Skid Row' and prisoners.^[47] The risk of transmission of infection associated with these groups was said to be at least ten times as great as that arising from voluntary donors.

26.34 It was not until 8 June 1995 that the US Food and Drug Administration (FDA) issued a formal recommendation that current and recent inmates of correctional institutions should be deferred, for a period of 12 months from the last date of incarceration, as donors of whole blood, blood components, source leukocytes and source plasma.^[48] While this timing may appear surprising, the FDA recommendation has to be seen in the context that blood transfusion practice in the USA was regarded as a matter for local rather than Federal regulation. In a paper submitted to the Inquiry, 'Collection of blood in prisons', for example, the SNBTS stated:

However as [Douglas] Starr recorded in his book, 'Blood' 'the Americans had stopped harvesting prison plasma for clotting factor by 1983 ...'. Although this was never formally documented, this is believed to be the case.

There was an informal (unpublished) agreement in late 1982 between the FDA and commercial companies to cease prison sessions ... (although it does appear that the American Red Cross may have still been collecting in prisons in 1983).^[49]

26.35 In addition, the Inquiry does not have sufficient evidence about the practice in the USA to place the FDA recommendation in its proper context or to draw any meaningful conclusions from it. In particular, the Inquiry has not heard evidence on how much blood was collected in US prisons, by which organisations and when, or the purpose to which any such blood or plasma so collected was put. A detailed investigation of these matters was outwith the Terms of Reference of the Inquiry. For these reasons, it would be difficult to draw any meaningful conclusions from a consideration of the FDA recommendation in isolation. Douglas Starr's comments appear to be a more reliable indication of when the practice stopped.

26.36 Internationally, practice varied. The Canadian Red Cross ceased collecting donations from prison inmates in 1971 after results from the Hepatitis B surface antigen test demonstrated conclusively that prison inmates in Canada had a significantly higher prevalence of hepatitis than the rest of the population. The decision was made as a matter of Red Cross policy and not in response to regulation.^[50]

26.37 A study in Finland of carriers of Hepatitis B antigen and transfusion hepatitis was published in 1974.^[51] The study found a higher incidence of Hepatitis B antigen among prisoner donors when compared with the non-prison donor population.^[52] The author of the report, Dr Timo Helske, commented:

The high frequency of carriers among prisoners (0.9 per cent) was consistent with the findings by other investigators.

There is at present no satisfactory explanation for these differences between various population groups. Drug addiction has been suggested as one possibility, since drug addicts are found most frequently among young adults. Illicit use of drugs no doubt accounts for a part of the acute cases of hepatitis type B and consequently for a few of chronic antigenaemia with chronic hepatitis. Together with tattooings this might at least to some extent explain the high prevalence of carriers among prisoners.

The HBAg carrier state has been related to socioeconomic and hygiene factors. A low socioeconomic standard might favour the circulation and dissemination of hepatitis B virus.^[53]

26.38 Dr Helske went on to note that in Finland, 'prisoners are indisputably a risk group in which a high HBAg carrier rate appears to be associated with a high risk of acute and chronic hepatitis'.^[54] By the time Professor Leikola joined the Finnish Red Cross Blood Transfusion Service in February 1975, a decision had already been taken to stop collecting blood in prisons.^[55] Professor Leikola considered it likely that the decision was taken on the basis of Dr Helske's study. He commented on two factors. Firstly, it was realised that not all Hepatitis B cases were recognised by the HBsAg test and that a good part of the people who screened negative were still carrying the Hepatitis B virus, then known to be the cause of potentially serious disease. Secondly:

In addition to that, [there] was the possibility of other viruses existing and [the] probable existence of other viruses. So if we would avoid transfusing Hepatitis B, that was not detectable by those tests that were used at that time, then an additional factor was that we would also avoid those viruses that presumably were also within prisoners.^[56]

26.39 When preparing his written statement to the Inquiry, Professor Leikola had discussed the collection of blood in prisons with Dr Helske. In oral evidence, Professor Leikola stated:

I discussed this matter with him and he said that he didn't remember when it was formally decided but he told me that when he showed his findings to Professor Nevanlinna,^[57] Professor Nevanlinna was, let's say, almost shocked, when he saw the difference between the prisoners and the donors in the general population. They had also thought that maybe within [the] army, where the conscripts would come voluntarily and in groups and so on, that was not a closed institution but not very far from that. They were a little bit afraid whether there would be a higher incidence of Hepatitis B also and they were quite relieved when they saw that it was 0.2 per cent, which was the same as from mobile units from the Helsinki larger area.

Dr Helske told me that after he had shown these results to Professor Nevanlinna, these were discussed by the senior staff and everybody agreed that, because of this high prevalence, it was probably much safer to stop the donations at prisons, especially because only a small proportion of the blood supply was coming from prisons.

If I may add here, I have the feeling that these results were discussed at the meeting of the Council of Europe expert committee in May 1974. I was not personally involved so I have been thinking of these connections, because in the same group there was Dr Maycock from the UK. He was representing the UK to that group. There were Dr Moore, Dr Freiesleben from Copenhagen, Dr Hogman from Stockholm who wrote this ISBT recommendation,^[58] including also avoidance of prisons as a source of blood.

So I think that this has been discussed at that time within a larger European group, especially because Dr Helske refers here to the finding being of similar magnitude as in other Scandinavian countries. And I'm quite sure that he refers to Sweden and Denmark and therefore these people were aware of the higher incidence of Hepatitis B antigen within prison inmates.^[59]

26.40 The practice of other European countries in respect of the collection of blood in prisons is helpfully shown in a 2004 survey conducted by the European Blood Alliance (EBA).^[60] The Table 26.1 in the Appendix to this chapter contains a summary of replies of the EBA member states.^[61]

26.41 There was a clear difference of practice among European blood transfusion services in respect of collecting blood from prisoners. In particular, as reflected in the table:

• Some countries never collected blood from prisoners (Denmark, the Netherlands^[62] and Eire).
• Some countries introduced a permanent or temporary deferral of blood collected from prisoners in the 1970s (Switzerland, 1970;^[63] Belgium, mid-1970s; Finland, 1975).
• Some countries ceased the collection of blood from prisons in the 1980s (England and Northern Ireland, both 1983; Scotland, 1984; Luxembourg, 1985; France, 1985-89).^[64]
• Other countries did not introduce permanent or temporary deferral of blood donation by prisoners until the 1990s (Portugal, 1990; Austria, 1995; Germany, 1996; Norway, 1997).^[65]

Collection of blood in Scottish penal institutions

26.42 The evidence obtained by the Inquiry indicates that blood was collected from penal institutions in Scotland from at least 1957 until the last prison session took place in each individual region.^[66] The last prison donor sessions took place respectively in the south east (Edinburgh) on 22 December 1981; north (Inverness) on 24 February 1983; north east (Aberdeen) on 28 July 1983; east (Dundee) on 2 August 1983; and west (Glasgow) on 25 March 1984.^[67]

26.43 The donations collected in each Scottish RTC between 1971 and 1984, as shown in extant records, are shown in Table 26.2 in the Appendix to this chapter.

26.44 The percentage of total blood donations in Scotland collected from penal institutions fell from 2.38% in 1975 (5915 of 248,558 donations) to 0.11% in 1984 (342 of 308,617 donations), with an annual average over that period of 1.097%.^[68]

26.45 The donations collected by each Scottish RTC from penal institutions between 1971 and 1984, as shown in extant records, were:

Table 26.3: Donations collected at Penal Institutes in each Scottish RTC 1971-84

Year	Region
	West RTC	South east RTC	East RTC	North east RTC	North RTC*
1971	n/a	1126	n/a	n/a
1972	n/a	902	n/a	n/a
1973	n/a	875	n/a	n/a
1974	2716	973	905	531
1975	3532	807	952	624
1976	501	792	780	560
1977	1462	264	886	98
1978	1929	151	840	516
1979	2516	689	716	450
1980	1920	283	770	91
1981	2274	203	609	274
1982	1526	0	543	287
1983	2622	0	322	176
1984	342	0	0	0
* From 1971 to 1983 NRTC visited 1 prison, Inverness (Porterfield) Prison. Donation numbers are not available as the records were lost in a flood.

26.46 With the exception of 1976, in each year between 1974 and 1984, Glasgow and the West of Scotland collected the greatest number of donations from prisons (averaging about 59% of the total for the period). The West, having the largest centre of population in Scotland, accounted for around 47-50% of all donations collected in Scotland over the period for which total donation values are available. Prison collections made a proportionately higher contribution to total donations in that region than elsewhere in Scotland.

26.47 Caution is needed when interpreting these figures on an annual basis.^[69] In all regions, at some periods while the practice continued, prison donations were collected at certain times in the year rather than throughout the year, in some instances to plug a gap in the supply from the non-prison population. For a local holiday week, the prison collection might have been more than half the transfusion centre's total supply and critically important.^[70] As Professor Cash understood it from Dr Mitchell, it was believed that the Glasgow Fair holiday would have created a significant problem but for collections in prisons at certain periods.^[71] The annual average underestimated the impact that would follow from ceasing prison sessions during such vulnerable periods.

26.48 The pattern of collections in prisons has to be considered in the light of historical facts, so far as they can be ascertained. Much of the written material dealt with drug addicts, paid donors and inmates of penal institutions together and is taken as a whole where necessary, since context and the sense of the evidence may be lost by selective citation.

Conduct of prison sessions

26.49 A question arises whether, during the periods when blood was collected in prisons, borstals and other similar institutions, any modification of the procedures at routine donor sessions was adopted to reflect the particular circumstances of the closed environment and the particular population involved.

26.50 So far as SNBTS policy was concerned, the conduct of donor sessions in penal institutions was, as far as possible, identical to that of donor sessions anywhere else. The sessions were arranged through a member of staff in the institution, usually the director, who would delegate organisation to a medical officer. The dates were set well in advance. The same mix of personnel attended. SNBTS staff would work on the premise that the donors were volunteers when they attended. Dr McClelland acknowledged that there would be discussion around the nature of volunteering in a penal institution. For the purpose of the sessions, however, it had to be accepted that the donors were volunteers. Dr McClelland was unaware of there being any 'unique' or 'explicit' measures for sessions in prisons.^[72]

26.51 Superficially, the structure of donor sessions was in accord with that description. The evidence of Mrs Rosalind Prior on the practice in Glasgow and the west of Scotland in the early 1970s up to the beginning of the reference period has been set out in Chapter 18, Collection of Blood - General, paragraph 18.38.

26.52 Mrs Prior's account emphasised the degree of dependence on donor recollection and reliability that was inherent in the system. In relation to prison sessions, she said:

When we attended the prisons to collect blood from prisoners it was the same process. However, as it was generally a bigger set-up we would generally have more staff present. During the year the mobile unit attended Shotts, Polmont, Corntonvale, Lowmoss and Barlinnie prisons. The unit always attended Barlinnie Prison for the two weeks of the Glasgow Fair holiday in July. My impression was that the incentive for prisoners to donate blood was that it was just a way of getting away from what they would normally be doing. However, the prisoners at Barlinnie Prison, Glasgow told me that they had been informed by the "screws" (prison officers) that if they donated blood they would be given a cigarette and sugar. They were not pleased when they found out that this wasn't the position ... I am asked whether there was any pre-selection/exclusion by the prison authorities of prisoners who were allowed to donate blood. I am unaware of whether there was or was not such a policy.

....

There was no difference in the procedure, including questions asked, between prison and other donor sessions. I do not recall any suggestion being made that blood collected from prisons was different from blood collected elsewhere.^[73]

26.53 Mrs Prior had identified two differences between donation by prisoners and donation by members of the general public. There was an opportunity to escape prison routine, even for a short period, and there was the potential for incentives to be offered, genuine or otherwise. So far as Mrs Prior's evidence is concerned, neither of these differences appears to be material for present purposes. A different perspective was presented by Dr Ewa Brookes. Prior to her appointment as Regional Director at the Dundee RTC in May 1981, Dr Brookes had worked as a Consultant in the South London RTC. She scheduled herself as session medical officer on three successive sessions in a London prison, possibly in 1978-79. She summarised her experience:

• While volunteers might mention a past history of jaundice, or a self-limiting illness long ago, any admission of recent injury, or an illness which might be a sign of weakness, eg heart disease or diabetes, was never made.
• If admission was made (one man told her of a myocardial infarct [heart attack] three weeks before), it was whispered, for fear of making him appear vulnerable to the other prisoners.
• Apart from the obvious attraction of a group of professionally courteous women as donor assistants, prisoners had a change of activity and an easier day after donating, so were keen to do so.^[74]

26.54 The third point gives a slightly different colour to the points made by Mrs Prior. The other two draw attention to an aspect of institutional life that made it much more likely that relevant information would be withheld by institutional donors than donors from the general public. Dr Brookes' response indicates that she was concerned about the practice. Following these sessions, she met the Prison Medical Officer of the London prison she had attended (a senior and very busy man), indicating the reasons for the BTS prison sessions and the expectation that volunteers were pre-screened. She was forcefully advised that he had duties in more than one prison and many much greater problems than those of donor selection. The information was reported to her Director and discussed at the Senior Staff Meeting in her Transfusion Centre. It reinforced previously held concerns and the decision was made to phase out sessions in prisons and young offenders institutions.^[75]

26.55 The Inquiry sought the views of the Scottish Government about the role of prison medical officers. It was explained:

The Secretary of State had a statutory power to appoint prison officers, including medical officers (being medical practitioners duly registered under the Medical Acts), but in practice medical services were the responsibility of each respective prison; there was no national prison medical service. Each prison, other than Barlinnie which directly employed two or three full-time medical officers, had a contract with a local surgery or health centre. There could therefore be a number of different GPs providing medical services to each prison on a part-time basis. Medical officers received very little, if any, guidance from prison management, and the expectation was that they would bring knowledge and independence from their respective general practices. This meant that the practice between, and even within, prisons was varied.^[76]

26.56 As regards the involvement, if any, of prison medical officers in the collection of blood at prisons the Scottish Government advised:

Up until 1983 SNBTS might visit each prison twice a year. Usually the chief nurse officer in each prison was the SNBTS contact and authorised the routine visits. Medical officers were not involved and, not attending the prison every day, often might not even have known the visit was taking place. Also, given that medical officers dealt with their prison patients on the same basis as community patients, in terms of confidentiality, the identities of those known to have been misusing drugs were not disclosed to SNBTS on a routine basis.

It is likely that the SNBTS doctors who attended the donor sessions would have been able themselves to identify those prisoners who were misusing drugs intravenously, through sight of needle marks.^[77]

26.57 In answer to a query as to whether any steps were taken by those in the prison medical service and/or by the Scottish Prison Service to prevent prisoners who were dependent on drugs or had a history of drug use from attending donor sessions in penal establishments, the Scottish Government replied:

We have been unable to ascertain whether any such steps were taken. Neither medical officers within prisons nor the government staff in the Scottish Prison Service were involved with SNBTS visits to prisons.^[78]

26.58 In summary, there was no evidence before the Inquiry that any additional steps were taken at prison donor sessions in Scotland to seek to screen out higher risk donors such as those who had ever injected drugs. The response from the Scottish Government noted above suggests that no such additional steps were taken, as does the evidence of Dr McClelland and Mrs Prior that there was no difference in the procedure, including questions asked, between prison and other donor sessions.

26.59 Whether that was appropriate depends to a considerable extent on whether there were grounds for distinguishing donors in penal institutions from donors in the general public. The question is whether there were features of the prison population that gave rise to risks that were relatively greater than among donors from the general public. This question is discussed below.

Chronological narrative of United Kingdom views on prison collection

26.60 In the absence of any comprehensive statement of developing policy in the United Kingdom, and Scotland in particular, it is appropriate to set out a chronological statement of the evidence obtained.

1970-1974

26.61 At a meeting of the English and Welsh RTDs on 6 October 1971,^[79] it was noted that the American Red Cross had stopped collecting blood from donors in correctional institutions from July 1971, because it was generally accepted in the USA that the incidence of infective, but Australia antigen-negative, donations was higher among prisoners than from voluntary unpaid donors and because the incidence of Australia antigen among prisoners was ten times greater than among voluntary unpaid donors.^[80] At the time, all RTCs collected blood in prisons, borstals or other similar institutions. The RTDs reported differing experiences and impressions.

26.62 Several RTDs did not consider that the association of donations from such sources with cases of hepatitis was any greater than that of donations from other donors. Two reported a greater incidence of Australia antigen-positive (Au-positive: that is, positive for the Hepatitis B surface antigen HBsAg) results among prisoners than among other donors. Recorded discussion included comments on the great difficulty in following up prisoners found to be Au-positive and arranging for confirmatory tests, particularly after prisoners had been discharged. In one prison the names of donors were not given to the RTC. One attendee at the meeting, Dr Grant, said it was sometimes difficult to keep any record at all of prisoner donors. Another Director suggested that prison and borstal governors should be asked to prevent any individuals known to be or to have been a drug user from volunteering as a donor. The outcome was indecisive:

After further discussion the meeting ... decided that before considering whether to stop collecting blood in prisons etc. more information should be obtained about the association of such donations with cases of serum hepatitis.^[81]

26.63 The suggestion that prison authorities should be asked to prevent any individual known to be, or to have been, a drug user from volunteering as a donor came to naught. At a meeting of the English and Welsh RTDs on 12 January 1972,^[82] several Directors reported that they had been informed by prison governors or medical officers that there were no drug addicts in the prisons concerned. It was suggested that any prisoner should cease to be a donor if their blood, whether HBsAg-positive or not, had been associated with a case of serum hepatitis. The minutes record that it was agreed to leave the matter until there was more information about the incidence of HBsAg-positive test results among inmates of prisons and borstals.^[83]

26.64 In March 1972 the British Medical Journal published a paper by Dr Wallace and colleagues at the Glasgow and West of Scotland RTC on the prevalence of Australia antigen in donors in that region.^[84] During a period of one year all of 105,724 blood donations were tested for Australia antigen and its antibody using a modified immunoelectroosmophoresis (IEOP) test. It was found that, in donors tested for the first time, male prisoner donors had a significantly higher incidence of Australia antigen (0.65%) than non-institutionalised male donors (0.12%). In addition, non-institutionalised male donors had a higher incidence of Australia antigen than female donors (who had an incidence of 0.05%). Overall, the incidence of Australia antigen-positive donations among prison donors (0.65%) was just under seven times higher than that in males and females in the general public (0.10%). The authors stated:

The high incidence of Au antigen of ... 0.653% ... in men prisoners has no obvious explanation. Viral hepatitis is not a serious clinical problem in the two institutions concerned, and the positive donors are not drug addicts. What is not known is whether or not these men were Au positive at the time of their first imprisonment. The high incidence may be related to social habits and to hygiene.^[85]

26.65 Professor Leikola was of the view that, had he read Dr Wallace's article in 1972, he would probably have felt that the explanation for the higher prevalence of Hepatitis B in prison donors being due to 'social habits and hygiene' was a plausible one.^[86] As noted below, his views were to change after reading Dr Helske's paper in 1975.

26.66 The English and Welsh Regional Transfusion Directors met on 7 June 1972.^[87] The Directors had made attempts to collect data reflecting the incidence of infection in the donor population from before the reference period. There was particular interest in the risk associated with prisoners, especially drug addicts. The results in England and Wales were reported.^[88] An overall incidence of 1:1500 antigen-positive and 1:1300 antibody-positive donors was reported. No antigen- or antibody-positives were observed among 1449 armed forces donors (including US Air Force personnel). On the other hand, in two borstal institutions and two prisons, antigen and antibody were detected in one in 488 donors (total donations tested, 976). In a discussion on the incidence of Australia antigen in the general and other populations, it was noted that of 107 donations involved in 19 cases of serum hepatitis, the incidence among donors from prisons and borstals was the same as that among all donations collected, 'which might suggest that the risk attaching to blood from such donors (normally bled only once) was not, in fact, higher than that from new general public donors'.^[89] The minutes note that, 'It was reported that RTC Edgware ... had discontinued collecting blood in prisons and borstal institutions'.^[90] Various figures, based on small population sizes, were given for the incidence of Australia antigen in donations from prisoners and members of the public in different regions in England. The minutes note that, '[i]n view of these discrepancies the meeting agreed that further information should be collected before it was decided to discontinue collecting blood in prison and borstal institutions'.^[91]

26.67 The English and Welsh RTDs next met on 20 September 1972.^[92] Detailed returns from the English regions indicated a significantly higher incidence of Australia antigen among prisoners than among the general and university populations.^[93] By then, almost all donations were being tested and quarterly returns of positive tests were required.^[94] The minutes record discussion of a donor who was found to be Australia antigen-positive in prison and, before the result could be confirmed or the donor informed, he had been released and all trace of him lost. The RTC of the region where he was thought to live and neighbouring RTCs had been informed. It was agreed that the names and addresses of untraced Australia antigen-positive donors should be sent under confidential cover to all RTCs. The minutes noted that Edinburgh and Glasgow RTCs were collecting blood from prisons and that, 'In Edinburgh the incidence of Australia antigen positive tests in prisoners is no higher than among the general population; in Glasgow the incidence in prisoners is significantly higher'.^[95]

26.68 The minutes include an appendix showing the incidence of Australia antigen among different groups of donors at the Sheffield, Tooting, Bristol, Cambridge and Wessex RTCs in 1971-72.^[96] In each RTC the incidence of Australia antigen among prison donors was significantly higher than that among the general public. Overall, the incidence of Australia antigen in these centres among prison donors was 0.373% (22 Au-positive donors out of a total of 5903 prison donors), compared with an overall incidence of Australia antigen among the general public at these centres of 0.051% (175 Au-positive donors out of 342,948 donors). Investigations over the middle of 1972 had shown that the incidence among prison donors in these English regions, of just over seven times that in donations from the general public, was similar to the increased incidence of Australia antigen reported in prison donors in Glasgow and the west of Scotland.^[97]

26.69 The English and Welsh RTDs met on 26 September 1973.^[98] Representatives from the Scottish Home and Health Department (SHHD) and the SNBTA were present. An SNBTA Director had also been present at the meetings held in October 1971 and June 1972. It was noted that the incidence of Australia antigen in prison donors was higher than in the general public.^[99] It was recorded that the adjusted data appeared to show that the frequency of antigenaemia among members of the armed forces was similar to that among new donors from the general public. The minutes state:

The meeting considered whether NBTS should stop collecting blood in prisons. Seven directors^[100]... thought prisoners should no longer be bled because the incidence of antigenaemia not detectable by IEOP was probably higher in this population than among the general public. Seven^[101]... thought that screening for antigen gave adequate protection, and that blood collection in prisons should be continued until the statistical significance of the figures in RTD(73)25^[102] had been examined. [Name redacted] undertook to arrange this. It was agreed that if it were decided to discontinue bleeding prisoners, the Department should inform the Home Office before any local action was taken.^[103]

26.70 At a meeting of the SNBTA Directors on 4 October 1973^[104] it was noted, as a matter arising from the meeting of the English RTDs, that Dr William Maycock^[105] 'had produced data on the incidence of Au positive blood among prisoner donors. The evidence was being re-examined and English directors were considering withdrawal of prison sessions'.^[106] The minutes do not disclose any further discussion of the matter by the Scottish Directors.

26.71 The English and Welsh RTDs met on 24 April 1974.^[107] Dr Albert Bell attended on behalf of the SHHD and Dr Brodie Lewis, Director of the Aberdeen RTC, attended on behalf of the SNBTA. There was discussion of an article that had appeared in The Sunday Times in connection with a decision by the North London Blood Transfusion Service, Edgware, to suspend use of blood collected from donors from tropical areas who were considered to be a 'high risk' group as a result of having a higher incidence of Hepatitis B antigen.^[108] It was agreed that an ad hoc group should be formed to consider 'what groups of donors can be identified, the use of whose blood should be given special consideration and whether any groups can be identified whose blood should be rejected'.^[109]

26.72 In July 1974 the NBTS in England and Wales compiled data for two periods: the year 1973 and January to March 1974.^[110] The data for the whole year showed values for the incidence of HBsAg (Hepatitis B surface antigen) and anti-HBs (Hepatitis B antibody) in new general public and factory donors of 1:1107 and 1:772 respectively. In prisons, borstals etc, the relative values were 1:214 and 1:338 respectively. The incidence of infection in penal institutions in 1973 was relatively high.

1975-1979

26.73 On 6 January 1975, Professor J Garrott Allen, Stanford University School of Medicine, wrote to Dr Maycock, Director, Elstree.^[111] It appears from his letter that by the beginning of 1975 some practitioners in the United States of America were campaigning for a volunteer blood donation programme that would exclude high-risk donors in certain groups from giving blood. Professor Garrott Allen pointed out the increased risk of hepatitis from Factors VIII and IX produced by US commercial companies using blood taken from high risk donors. He also stated:

The other imponderable which has troubled most of us is the ineffectiveness in screening for the HB antigen ... Whatever this agent(s) may be, it still seems to be more frequently encountered in the lower socio-economic groups of paid and prison donors. It is minimal among volunteer donors. It seems that the most certain method we have for reducing the number of carrier donors at the present time is still to determine whether or not the donor has been paid in money or reduction of his prison sentence.^[112]

26.74 Professor Garrott Allen had previously published a book in which he had reported the results of his studies into post-transfusion hepatitis in the USA and had stated:

The risk of serum hepatitis from transfusions derived from prison and Skid Row populations is at least 10 times that from the use of volunteer donors.

....

The most practical methods of reducing the hazard of serum hepatitis from blood are ... especially by excluding, if possible, all prison and Skid Row or commercial donors.^[113]

26.75 In his evidence to the Inquiry Professor Cash stated that he was not, at the time, aware of Professor Garrott Allen's letter to Dr Maycock but was aware of 'the whole issue of the dangers of paid donors'.^[114] He commented that paid donation was not a phenomenon in the United Kingdom. Similarly, Dr McClelland was not aware of the letter but was aware of Professor Garrott Allen's book highlighting the risks associated with paid donors.^[115]

26.76 For his part, Professor Leikola was unaware of Professor Garrott Allen before being asked to assist the Inquiry as an expert witness. On being shown Professor Garrott Allen's letter to Dr Maycock he commented:

I think that it's very much in line with what we did in Finland. However, we were thinking at least at that time that these problems of prison conditions and drug addiction were quite different in America as compared to northern Europe and therefore we were not quite as anxious of these numbers as they were over there. However, I think that this statement here is very much in line with what was thought in our country.^[116]

26.77 In February 1975 the Advisory Group on Testing for the Presence of Hepatitis B Surface Antigen ('The Maycock Group'), established in 1970, produced a draft version of their second report.^[117] In May 1974 a sub-group of the Advisory Group had considered the problem of certain parts of the population in whom the incidence of HBsAg was known to be high.^[118] The report of the sub-group was included in an appendix to this version of the report of the main group.

26.78 As regards blood collected in prisons, the appendix noted:

There is a relatively high risk of hepatitis being transmitted by the blood of prisoners. But there is probably an equally high risk in other groups of the population, e.g. drug addicts, who are not as easily identified in advance as prisoners. It is not necessary to discontinue the collection of blood at prisons and similar institutions provided all donations are subjected to one of the more sensitive tests referred to ... above [RPH or RIA].^[119]

26.79 The appendix was not included in the final version of the second report of the Advisory Group, published in September 1975.^[120] Instead, the conclusion reached by the sub-group on the continued collection of blood from donors in prisons was reflected in a letter dated 1 May 1975 from Dr Henry Yellowlees, Chief Medical Officer for England, to all Regional Medical Officers in England.^[121] Dr Yellowlees noted that the DHSS had recently received advice from a group of experts^[122] on the use of blood donations from certain categories of donors. The letter essentially repeated the wording of the appendix of the draft second report of the main group and, in relation to prisoners, stated:

There is a relatively high risk of hepatitis B being transmitted by the blood of prisoners. But there is probably an equally high risk in other groups of the population, eg drug addicts, who are not as easily identified in advance as prisoners, if they can be identified at all. The advice we have received is that it is not necessary to discontinue the collection of blood at prisons and similar institutions provided all donations are subjected to one of the more sensitive tests referred to above [that is, reversed passive haemagglutination (RPH) and radio-immunoassay (RIA)].^[123]

26.80 The issue of the use of prisoners as blood donors was determined for the time being for England and Wales by Dr Yellowlees' letter. That letter further noted that the Memorandum on the Selection, Medical Examination and Care of Blood Donors, issued for the guidance of RTDs, would be revised to take account of the advice received and that a copy of the letter was enclosed for each RTD.

26.81 A copy of Dr Yellowlees' letter of 1 May 1975 was also sent to the SHHD. Dr Graham Scott, Deputy Chief Medical Officer, noted in a memorandum of 8 May 1975^[124] that the Maycock Group had set up a small working group to consider 'geographical and racial factors' and produced recommendations in the form of an appendix which appeared in an early draft of the report, but that '[i]t was our view as soon as we saw it and indeed finally the view of the whole Advisory Group that the inclusion of such an Appendix could be inflammatory and the Appendix was therefore dropped'.^[125] Dr Scott further noted that all he intended to do with Dr Yellowlees' letter was to ask Dr Archibald McIntyre, Medical Officer, SHHD, to discuss the recommendations with the National Medical Director of the SNBTS and to establish the practice in Scotland at that time and when the more sensitive methods of antigen screening had been instituted. He also indicated that if the practice recommended was not what the Scottish centres were doing, or intended to do, then all that would require to be done would be for the department to send a letter to the National Medical Director drawing his attention to the recommendations and asking him to take the matter up with the Regional Directors.

26.82 On 16 May 1975 Dr McIntyre sent a copy of Dr Yellowlees' letter to Major-General Hugh Jeffrey, National Medical Director, SNBTS.^[126] The emphasis in Dr McIntyre's letter was on blood from donors from endemic malarial areas and related to the risk of transmission of malaria. There was no discussion in Dr McIntyre's letter of donations from prisoners.

26.83 Dr Yellowlees' letter of 1 May 1975 was circulated to the SNBTS Directors and was considered at their meeting on 11 June 1975.^[127] The discussion appears to have been restricted to the question of blood from donors from endemic malarial areas. The minutes do not record any discussion of donations collected from prisoners, including whether the practice should continue. Professor Cash had no recollection of the discussions which took place at that meeting but concluded that the SNBTS accepted the views of the CMO (England), which he suggested almost certainly enjoyed the support of the CMO (Scotland) and that of the Senior SNBTS Director, Dr John Wallace.

26.84 Dr McClelland was not aware of Dr Yellowlees' letter at the time it was distributed. In giving oral evidence, he thought in retrospect that it was very strange and surprising advice from a CMO, a public health doctor. He did not know from the letter where the expert advice on transfusion came from but suspected it might have been from a committee chaired by Dr Maycock, a subgroup of that advisory group. He had never been privileged to see any of the deliberations of that subgroup. He repeated that it was 'a very surprising letter'.^[128] He was asked to comment further on Dr Yellowlees' advice and said:

The change, obviously, here was all about suddenly having a test for Hepatitis B. I feel that the advice about prisons surprises me because it's wider than just hepatitis ... I would have expected an experienced public health expert to have been concerned about essentially the whole gamut of infection risks among prison donors and also about possibilities of ... prisoners being poorly nourished perhaps being rendered iron-deficient. There would be quite a lot of reasons why [in] what is essentially a pretty underprivileged community, one should think very carefully about asking them to donate blood, both from the safety of the patient and possibly also for the safety of the donor. I do find it surprising, despite that statement.

Q. So in 1975, if one was considering the practice of collecting blood from prisoners, should there have been any consideration of whether there was a higher risk of prisoners transmitting infection?

A. I think that's what I'm saying .... The focus here was on Hepatitis B, and I think there must have been a period after the discovery of the Australia antigen by Blumberg et al, which moved very rapidly on to having some really rather insensitive tests, when ... there was a sense that we have cracked the problem of hepatitis, and in the background these guys, particularly in the States, were very rapidly realising that they probably hadn't cracked the problem of hepatitis. Then, when the Hepatitis A tests became available and the importance of examining liver enzymes perhaps became more widely realised ... it very quickly became evident to people who were looking at all the facts that there was something else going on.

Q So again trying not to look back with the benefit of hindsight, do you think that any consideration between, let's say, 1975 and to the end of the 1970s, the second half of the 1970s, of whether it was appropriate to continue to collect blood from prisoners, or any such consideration to have included consideration of the question of non-A non-B hepatitis?

A. I think to put it in those specific terms is probably asking for an incredibly quick knowledge transfer, to be quite honest. I mean, we are talking about these earliest inklings that there was another entity which are referred to here. It is perhaps a little unreasonable to expect that to move instantly into a completely different context and be considered carefully and reflected on and applied. Life's not like that.

Q. So not even between 1975 and, say, 1979?

A. That's a matter of opinion. This is conjecture, not evidence.^[129]

26.85 Dr McClelland did not know whether the view expressed in Dr Yellowlees' letter had ever been retracted. He accepted that it represented the government's advice and thinking at the time.^[130] In some respects, however, his views were rather equivocal. He said he would have expected someone with an overview of some of the basic issues in public health to have paused and thought, 'Hang on, prisons can't be a very good idea'. It had been known for a long time, and he considered that common sense would tell one, that prison was a place where living hygiene standards were not very good, where there would be people who had difficult lifestyles and so on. All gathered together, it just did not make sense to him.^[131]

26.86 The second report of the Maycock Advisory Group was published in September 1975.^[132] As noted above, the appendix that had appeared in an earlier version of the report setting out the views of the sub-group, on the collection of blood from donors from endemic malarial areas and from prisons, did not appear in the final report. The second report noted that blood and blood products could also transmit other forms of hepatitis which did not appear to be associated with the presence of HBsAg.^[133] In a chapter on safety in laboratories the report noted that specimens from various categories of patient should be labelled 'high risk' at the time of collection, including specimens from drug addicts.^[134] As noted above at paragraph 29.79, as a result of the procedures adopted the Advisory Group's views on prison collections were not published generally as part of its second report but were, rather, incorporated with advice to medical professionals issued by the Chief Medical Officer for England.

26.87 In 1977 Dr Edward Follett and Dr Ajay Chaudhuri reported on the link between drug abuse and Hepatitis B Infection.^[135] The authors compared the risk factors in cases of acute HBsAg in Greater Glasgow with the risk factors in such cases across the whole of Scotland and concluded:

It is apparent from these observations that drug abuse is giving rise to a very significant number of the total cases of acute hepatitis B in Scotland. The noted percentage for 1976 (27.2) is very likely an under-estimate as several patients may not be asked about or admit to drug abuse or association with drug abusers. It is also evident that this is not another problem peculiar only to the west of Scotland. It occurs throughout Scotland and what is seen in Glasgow reflects but does not magnify what occurs in the whole of Scotland.^[136]

26.88 In his book published in 1977, Blood Transfusion for Clinicians, Dr Wallace (Dr Mitchell's predecessor at Glasgow) commented, in a chapter on the collection and administration of blood:

Inmates of prisons and other institutions should be treated in the same way as other volunteers, provided the donation is proved to be HBsAg negative.

In respect of the transmission of viral hepatitis particular attention should be paid to volunteers who [are] suspected of being drug addicts or who have a tattoo. It is probably wise not to accept a volunteer who has been a drug addict.^[137]

26.89 In a chapter on the hazards of transfusion therapy Dr Wallace stated:

This is the appropriate time to consider certain controversial features of donor selection in respect of the transmission of hepatitis by transfusion. It has been established that within any potential donor population, certain groups have a higher than average incidence of HBs antigenaemia. In particular, HBs antigenaemia is more prevalent in male prisoners, and in volunteers from tropical areas. Some transfusion services have declined to accept volunteers in prisons and among immigrant populations. This ultracautious approach may be doubly undesirable. Few transfusion services have so much donor blood available that offers of substantial help can be refused in blanket fashion. Indeed visits to prisons to collect blood can often be arranged when the general intake of blood is low because of the holiday season. The incidence of HBs antigenaemia among male prisoners in Scotland is less than 1 per cent using the most sensitive techniques of testing, thus generous offers of useable donations would be lost by placing a total embargo on prison donors. Furthermore it is socially and psychologically undesirable to exclude prisoners and volunteers from tropical areas from the donor population. Acceptance of prisoners as donors helps to rehabilitate, and some of these volunteers become regular donors after their release.^[138]

26.90 Dr McClelland's general comments on Dr Wallace's book are noted in Chapter 14, Knowledge of Viral Hepatitis 1, paragraph 14.26. In his view the underlying assumption that, with the benefit of HBsAg screening and a low incidence of Hepatitis B infection, 'somehow non-A, non-B hepatitis just wasn't a problem in the UK', was inconsistent with the knowledge that only 25% of cases of post-transfusion hepatitis could be explained by Hepatitis B and that other causes, including Epstein-Barr virus, were not significant. He had similar difficulty with the conclusions of Dr Maycock's study which appeared to conclude that non-A, non-B Hepatitis was not a major transfusion problem.

1980-1984

26.91 Research interest continued in to the 1980s. A workshop on hepatitis was held in Edinburgh on 8 January 1981 where Dr Brian Dow of the Department of Infectious Diseases, Glasgow University, gave a presentation on preliminary work he had carried out in Glasgow and the west of Scotland. A paper was later published.^[139] The donor population studied included 352 prison donors, among whom Hepatitis B infection was known to be much more prominent than among the ordinary blood donor population and among whom it was expected that markers of NANB Hepatitis might also be more common, since NANB Hepatitis was a blood-borne virus assumed at the time to be similar to Hepatitis B.^[140] SGPT/ALT^[141] testing showed that of the 352 prisoners, eight had ALT levels exceeding the upper level of normal, at 35; six had levels greater than 42 and one had a level of 125. Of 164 other donors, only one exceeded 35 and one exceeded 42. Dr Dow would have expected more of the other donors to test positive. Even allowing for that, however, prison donors showed a higher level of elevated ALT compared to usual donor sessions.^[142]

26.92 In the discussion section the authors noted:

The index case of [NANB] hepatitis is usually in a haemophiliac, drug-abuser, or post-transfusion patient who may have developed jaundice as a result of a transfusion or a toxic reaction, and not from infection by an unknown agent.^[143]

26.93 In his evidence to the Inquiry, Dr Dow was asked what was meant by the words in the article, 'among whom it was expected that markers of [NANBH] might also be more common'. He replied:

It was basically because non-A, non-B Hepatitis was thought to be a blood-borne virus similar to Hepatitis B. We were just assuming that it was very similar to Hepatitis B.^[144]

26.94 Dr John Gillon's evidence (paragraphs 26.103-26.104 below) would indicate that the assumption was not necessarily well founded but the results, showing a higher incidence of elevated ALT, provided independent evidence of a higher prevalence of NANB Hepatitis (subject to all of the reservations about ALT testing explored later).

26.95 At the same workshop Archibald Barr and others also presented data showing that the west of Scotland prison sessions had an increased incidence of both HBsAg and Hepatitis B antibodies compared to the general donor population.^[145] Over 10 years more than a million donations had been tested for HBsAg. The incidence in institutionalised males was 1:145, compared with 1:693 in non-institutionalised males. In oral evidence, Dr Dow said:

That's about five times greater. It is also quite important to notice there as well that in the ten years, as far as donors tested for the first time, we only had 6234 institutionalised donors tested for the first time. And you would expect that sort of figure in roughly two years, when you think about it. So we had a lot of repeat donors from prisons. And they had obviously been screened and, you know, obviously if they had been screened they were negative.

....

What I'm trying to get across is when you go to prisons, they are not all new donors. When we go to prisons, some of them have actually given before. So what we are talking about in the 1 in 145 is that if you had, let's say 290 blood donors actually donated at a prison session, you aren't going to get two Hep B positives there, you are probably going to get maybe 0.5.^[146]

26.96 The authors of the west of Scotland paper further stated:

Despite the high incidence of HBsAg in male prisoners ... viral hepatitis is not a serious clinical problem in the institution surveyed, and the positive donors are not drug addicts. This high incidence is probably related to social habits and hygiene.^[147]

26.97 Dr Dow said of this study that he assumed intravenous drug users would have been excluded by the donation staff.^[148] If that was correct, the total incidence of positivity would have been higher than found in those proceeding to donation.

26.98 Dr Mitchell was asked in oral evidence if he knew the basis for the statement that 'the positive donors are not drug addicts' and replied:

Dr Crawford was one of my consultants at that time and he, of course, had a close interest in this work. And it's over a period of ten years ... And Bob actually made a point of interviewing some of these people at the Prison Service, and saying, "Have you had any cases of hepatitis among the inmates since they were screened and do you have any evidence of any of these men being addicts?"^[149]

26.99 Dr Mitchell suggested that the reference to 'social habits and hygiene' did not refer to injecting drug use but may have included habits such as tattooing. He also stated that in the early days of blood transfusion intravenous drug use wasn't much of a problem and was something that came in 'much later'.^[150]

26.100 In oral evidence Dr Dow explained that 'social habits and hygiene' may have been a reference to homosexuality and the sharing of razors and toothbrushes, etc.^[151] He was asked, with the benefit of hindsight what he thought was the likely explanation for the higher prevalence of Hepatitis B in male prisoners. He replied, 'Probably drug abuse of some sort'. That link was not made at the time and Dr Dow could not give an explanation for that, other than to say, as far as he was concerned, he was unaware of the amount of intravenous drug use among prisoners until seeing a newspaper report to that effect in March 1984.^[152] Professor Urbaniak pointed out that some prisoners are liable to tattoo themselves, or others, and are likely to do so in unhygienic circumstances. He opined that, before the marked increase in intravenous drug use in the early 1980s discussed below, tattooing was a more likely explanation for the increased prevalence of Hepatitis B in the prison population than intravenous drug use.

26.101 In his evidence to the Inquiry Professor Cash stated that his impression was that the problem of drug use in UK prisons in 1983 was not the problem it is now.^[153] While Professor Cash had no recollection of having seen the paper at the time, his view now was that the assertion that the positive donors were not drug addicts and that the higher prevalence of Hepatitis B probably related to social habits and hygiene, was an error and that the most likely explanation for the higher prevalence was drug use and needle sharing.^[154]

26.102 Professor Leikola was of the view that if he had read the paper by Barr and colleagues in 1981 he would have considered the explanation for the higher prevalence of Hepatitis B in donors being due to 'social habits and hygiene', as 'possible, but not probable'. He explained:

[A]fter seeing Dr Helske's article in 1975, and after having discussed this problem briefly, when the people from the prison administration approached Dr Koistinen, I think that these explanations brought forward by Dr Helske - that was illegal use of intravenous drugs, needle sharing and then tattooing - were probably more plausible explanations than this one. And if I would have read this very carefully, I would have really questioned whether the explanation here is correct.^[155]

26.103 Dr Gillon, Consultant Physician at the Edinburgh and South East Scotland BTS from 1985, having heard other witnesses discuss the situation at this time, drew a distinction of some importance based on the relative infectivity of the diseases. He said that there is a gradation from Hepatitis B being highly infectious through HIV being pretty infectious to Hepatitis C, as it came to be known, being not very infectious. In the mid 1970s it was known that in any sort of residential setting Hepatitis B was likely to spread: unlike with Hepatitiis C, close family members of people with acute Hepatitis B or high level carriers of Hepatitis B are at risk, just through everyday contacts and excluding sexual contacts as a factor. The assumption that the reference to 'social habits and hygiene' was code for homosexuality was not necessarily correct. He thought that in situations like a prison, a residential school, or any institutionalised situation like the armed forces, Hepatitis B could spread quite readily.^[156]

26.104 Dr Gillon's observations made a particularly helpful contribution to understanding the evidence about infection in the prison population as a whole. On the one hand, they gave added weight to the risk of Hepatitis B transmission inherent in the institutional setting, tending to explain a high prevalence of infection among prisoners and, together with the known ineffectiveness of HBsAg testing, tending to reinforce the case against using prison donations. On the other hand, his evidence warned against the suggestion that a high rate of Hepatitis B transmission in the institutional setting necessarily implied a high rate of NANB Hepatitis transmission among prisoners. That would have to be investigated independently and, indeed, research proceeded to do so.

26.105 In 1982 the appropriateness of collecting blood from prisons in Scotland was questioned by the Medicines Inspectorate. The Inspectorate interpreted widely its remit for monitoring the implementation of processing and manufacturing standards for pharmaceutical products. While the licensing regime did not apply to state bodies such as the SNBTS because of the doctrine of Crown Immunity, the policy of the NHS in Scotland at the time was to aim to comply with good manufacturing practice, as if Crown Immunity did not apply.^[157]

26.106 The Medicines Inspectorate visited the Edinburgh and South East Scotland BTS on 10-11 March and 10-12 May 1982. A report was subsequently issued, to which the Edinburgh and South East of Scotland BTS responded, as already noted, on 12 January 1983.^[158] The report queried whether prisons and borstals were appropriate places to recruit donors.

26.107 On 25 March 1982 the Medicines Inspectorate inspected the Dundee BTS.^[159] The Regional Director, Dr Ewa Brookes, raised the question of prison donations with the Inspectorate. In her previous employment in London she had met them and regarded them as helpful critics, believing that they were likely to be supportive of her concerns. She advised the Inspectors that she understood that prison collection was in line with government policy but expressed her concern about the practice, as she had previously done whilst working in London. Her concerns were reflected in the Inspector's report.^[160]

26.108 The Inspectors' report of their visit to the Dundee BTS stated:

Brief discussions were ... held on sources of donated blood. At the time of this visit the Inspectorate had not visited donor sessions with Mobile Teams. However, it would seem most unlikely that we could continue to endorse the continued collection of blood from places such as Prisons and Borstals.

This recommendation is based on the following:

(a) Prison Medical Officers are often not involved in assessing the suitability of donors.

(b) The increased risk of infection associated with prison populations and the increased risk of transmitting disease through such donations.

(c) The unreliable answers to the pre-donation questionnaire that can occur in such environments as well as the motivation of some of the donors.^[161]

26.109 The Inspectors' reports of their visits to the Glasgow and West of Scotland BTS on 8-9 March 1982^[162] and the Inverness and North Scotland BTS on 5 May 1982^[163] made no mention of the practice of collecting blood in prisons, though clearly the practice continued in the West of Scotland at least.^[164]

26.110 By letter dated 4 June 1982, Mr David Haythornthwaite of the Medicines Inspectorate sent a copy of the draft reports of the visits to Professor Cash.^[165] Mr Haythornthwaite made a number of observations 'which may be "disconnected" but nevertheless apply to many centres'. In respect of 'source material', the selection and management of blood donors, Mr Haythornthwaite stated:

I have not observed donor sessions under the worst conditions however, I wonder whether certain 'high risk' areas are necessary or desirable. Prisons and Detention Centres would seem to come under this category and I would be interested in your views on this.^[166]

26.111 Professor Cash wrote to Mr John Watt, Scientific Director, PFC, on 5 July 1982 in respect of the Medicines Inspectorate's inspections.^[167] Professor Cash noted that there were one or two items arising that deserved 'our collective (national) attention'. He further noted that 'We need to consider, formally, in the not too distant future, the question of Sessions in Prisons etc. I would very much welcome your comments as to whether we should abandon this practice'.

26.112 In November 1982 Professor Cash prepared a General Response^[168] in the name of the Common Services Agency (CSA)^[169] to the inspection of SNBTS RTCs by the Medicines Inspectors. It was noted that a more detailed response would follow as soon as possible. The General Response referred to various steps that were under way including building works, the purchase of new equipment, staffing, improved record keeping and a quality assurance programme. There was no mention of the practice of collecting blood in prisons.

26.113 The Edinburgh and South East Scotland BTS also prepared a response to the Medicines Inspectors' report, dated 12 January 1983.^[170] It commented, in respect of the practice of collecting blood in institutions: 'Prisons and Borstals. We do not visit these regularly. No such sessions have been held for two years. These donors will only be used in an emergency'.^[171] The response noted that the new comprehensive guide to donor selection, which had been prepared and sent to the Medicines Inspectorate, was in routine use by donor selection staff.^[172] It did not distinguish the treatment of prison donors from donors in the general public.

26.114 Although collection from prisons had been raised by the Medicines Inspectorate in their draft reports sent to Professor Cash in June 1982, there is no minuted discussion of the matter at the meetings of the SNBTS Directors between June 1982 and March 1983.^[173] Nor does the topic appear to have been discussed at the meetings of the Ad-Hoc Medicines Inspectorate Steering Group of the CSA.^[174]

26.115 Dr McClelland did not recall the topic of the collection from prisons having been discussed at any Directors' meeting prior to March 1983.^[175] Similarly, Professor Cash did not recall having ever given the collection of blood from prisons any consideration prior to it being raised by the Medicines Inspectors in 1982. As Professor Cash put it in his evidence to the Inquiry: 'There were some big, big other issues and I suspect this was a casualty .... A major issue developed within the Scottish Office that major investment, capital investment, was going to be required [at PFC] to keep us on track with self-sufficiency'.^[176] Professor Cash explained that during this time the SNBTS was 'heavily committed' to addressing the problems of plasma and haemophilia, in particular, 'the problem of national self-sufficiency in plasma products', which was 'a monumental task'.^[177]

26.116 The issue of prison collections became live in March 1983. The minutes of the Directors' meeting on 29 March^[178] include comments on 'Blood Collection in Prisons and Borstals':

Dr Cash reported that the Medicines Inspector had commented adversely on the practice of collecting blood in prisons and borstal institutions, and he invited Directors to comment on the practices in each region and to give their views on the Medicines Inspector's criticism.

It was reported by all Directors present that sessions were held in penal institutions in all regions, although Dr Brookes and Dr Urbaniak intended to review the situation in their regions.

It was not possible for the Directors to agree on future policy, but it was agreed that Dr Brookes, as the Scottish representative, should ask the Working Party on the Selection and Care of Blood Donors to consider this issue. In the meantime, Dr Cash agreed to inform the Medicines Inspectorate of these SNBTS discussions and conclusions.^[179]

26.117 In oral evidence Professor Cash was asked if he had any recollection of the meeting on 29 March 1983 and replied:

My main recollections were that I was not the boss, that all consultants are equal, that I was merely there to co-ordinate and chair; that individual regional directors had the authority to stick to their view and so on and so forth. That was one of the main things.

I remember it being very heated because ... Dr Mitchell was very concerned that if this was precipitously implemented, he would run into problems of blood supply. These were regarded as local matters and we respected his position at that time.^[180]

26.118 This attitude to regional autonomy was common. In his written statement to the Inquiry Professor Cash explained that:

Without SNBTS Directors' consensus, there was no national management process for considering issues related to the location of blood collection sessions in the regions. Throughout the UK: this issue was strictly left to the RTDs and their teams and their priority was maintenance of supply. This management practice and the operational priorities enjoyed SHHD/DOH support.^[181]

26.119 Professor Cash was asked what his personal view was at the time about the appropriateness of continuing to collect donations in prisons and replied, 'I am as sure as I can be but not absolutely certain that my view was we should get out of that'. When asked why he was of that view he replied, '[o]n the grounds that the inspectors had raised, this is an issue, and for all of the reasons that they had stated'.^[182]

26.120 Professor Cash went on to say:

I don't think ... Dr Mitchell was totally opposed. I think the notion he felt of suddenly stopping when his donor programme had been planned for 12 months ahead and he foresaw major problems with shortages - we didn't second guess that, we accepted his point of view and it is very interesting that even by 1984 it had dropped from 2500 donors down to about 400.

So they were clearly, in 1983, as the others switched off finally, the West team were making strenuous efforts to detach at the same time ... Ruthven Mitchell found himself, he felt, in a very difficult position.^[183]

26.121 In her written statement to the Inquiry Dr Brookes stated, in relation to the meeting:

In discussion, I expressed my strong view that I thought the prison and young offenders sessions should be stopped, on the basis of my experience in London.

Although opinion was divided, it became evident that those Directors who wished to discontinue prison sessions, could do so.

....

In Dundee, immediately following the ... meeting of 29/3/83 I asked the Organising Secretary to phase out prison and young offenders sessions over the coming year.

The Centre's programme of donor sessions was generally confirmed for one year ahead, and outlined for the coming year.^[184]

26.122 Professor Urbaniak succeeded to the post of Director for the North East Region, his predecessor, Dr Brodie Lewis, having retired on 3 March 1983. Professor Urbaniak attended the meeting on 29 March 1983 and formed the view that prison collection was undesirable and decided to review the practice in the NE region.

26.123 By letter dated 12 April 1983,^[185] Professor Cash advised Mr Haythornthwaite that the practice of donor sessions at prisons and borstals had been discussed at length by the SNBTS Directors at the meeting. He noted that '[o]pinion was strongly divided and it was not possible, at this time, to obtain a consensus view'; that, nevertheless, the Directors recognised that the problem would require further discussions; and, to that end, that Dr Brookes had agreed to raise the matter at the next meeting of the UK Working Party which was currently considering the whole question of donor selection and care.

26.124 On 6 May 1983 Mr John Davies, Assistant Secretary, SHHD, sent a minute to the Private Secretary of Mr John MacKay, Under Secretary of State for Scotland, on the subject of AIDS.^[186] The minute noted that there had been recent media comment about AIDS, that the DHSS had prepared briefing material for the Prime Minister and that there were a few Scottish points to be made, including:

Donation Policy

The Blood Transfusion Directors in Scotland are very aware of the problem and have it under constant consideration. They are currently considering:-

....

(d) Avoiding collection in high risk locations such as prisons or where there is known to be a high proportion of homosexuals or drug abusers in the population.^[187]

26.125 On 27 July 1983 Mr JB Brown, Medicines Division, DHSS, sent a minute to his DHSS colleagues on the use of blood from prisons.^[188] In the minute he explained that, at a recent meeting of Medicines Division's Inspection Action Group, concern had been expressed about the collection and use of blood from borstal institutions and prisons. Blood Transfusion Centres in Scotland were making use of these sources, particularly prisons, and some, at least, of the English Blood Transfusion Centres were also understood to be doing so. He went on:

The Group considered this practice to be highly questionable because of the incidence of homosexuals and homosexual activity in prisons and the present unease about the incidence of AIDS among this group of people.

The Group asked to be advised of Departmental policy on the practice of collecting and using blood from borstals and prisons and I shall be grateful if you will let me have a note about this which I can pass on.

26.126 A handwritten note on Mr Brown's minute records that Mr Winstanley, DHSS, was to consult with Dr Diana Walford and respond. An SHHD note dated 11 August 1983^[189] recorded that Mr Winstanley had contacted the SHHD in respect of the Medicines Inspectorate's query relating to departmental policy on donor sessions in prisons and borstals 'given there is now AIDS'. Mr Winstanley told the SHHD: 'England and Wales have tended to shy-off in part because of Hepatitis' but he wondered what the Scottish practice was. The SHHD official referred to the discussion at the SNBTS Directors' meeting on 29 March 1983 in that regard. It was also noted that Mr Winstanley 'made the point that if policy was to be withdrawal, would probably need to consult Home Office in view of the importance placed on the social responsibility aspect of such sessions'.^[190]

26.127 By letter dated 23 August 1983,^[191] Dr Brookes advised Professor Cash that the Working Party on the Selection of Donors/Notes for Transfusion had met for the first time on 30 June 1983. Dr Brookes had raised the matter of donor sessions at prisons and borstals but noted that '[i]n fact, no discussion was necessary since as far as England and Wales are concerned these sessions have already been stopped. It is now left to the Scottish regions to decide whether they will do the same'.

26.128 In her written statement to the Inquiry Dr Brookes explained that:

[I]n 1983, the SNBTS National Director had asked me to raise the matter of prison sessions in the working party on Selection of Donors and when I did, I was advised by the chairman that there was nothing to discuss, it being his understanding that all English Transfusion Centres had stopped holding prison sessions. After the meeting I reported this to the Scottish National Director who asked me to ring round informally to check. I contacted 12 of the 14 Directors. In the minutes of the SNBTS Directors meeting of 8 December 1983 ... it is recorded that of the 12 Directors I had contacted, 11 were not holding prison donor sessions.^[192]

26.129 By minute dated 23 August 1983 Mr Winstanley, DHSS, replied to Mr Brown. He stated:

It is difficult to advise any particular Departmental policy on the collection of blood from borstals and prisons at the moment. It is for individual Regional Transfusion Directors to determine how and from where donations are sought in the light of the targets they need to achieve and the numbers of donors on their panels.

However, Transfusion Directors have been aware of the dangers of relying too heavily on prisons as a source of donations for some time i.e. prior to the advent of AIDS as a cause of concern, because of the risk of hepatitis in prisons, (also connected with the higher incidence of homosexuality) which can be spread through blood transfusion. Nevertheless, although most Regions, especially those with no shortage of donors, may not need to use prisons, there is at least one which has to view them as a major source of donations in order to meet targets.

AIDS has now of course called the wisdom of continuing to view prisons as a source of blood even further into question and the Directors are due to discuss it at their next meeting in September.^[193] If the risks are now considered too great to justify the continued collection from prisons, some measures will be needed to compensate for the loss of that source of donors, perhaps, for example, a system whereby Regions with no need to rely on prisons can take extra blood to be transferred to those Regions for whom the loss of prisons as a source of blood will cause difficulties ....

[I] gather that this problem has been debated by Transfusion Directors in Scotland, but no particular policy line emerged. We shall obviously need to liaise closely with Home Office also since they have in the past been very much in favour of blood donation by prisoners.^[194]

26.130 The SNBTS Directors met on 13 September 1983.^[195] As regards the Working Party on the Selection of Donors/Notes for Transfusion, the minutes state:

On the matter of collection in prisons and borstals it was noted that the Medicines Inspector had expressed concern at this practice. Owing to different circumstances in the Transfusion Regions the Directors had been unable to reach a consensus. The Chairman of the Working Party thought that the practice was diminishing in all regions in England and Wales. Dr Brookes felt strongly that donations should not be collected from prisoners because of the uncertainty about replies to questions concerning health.

It was reported that the practice had been raised at the Medicine Inspectors' Action Group who had referred it to the DHSS Administrative Division who confirmed that some Transfusion Centres in England still collected from prisons and borstals and that cessation of this practice would place them in difficulty. The NBTS Directors were due to discuss the matter and the DHSS would wish to consult the Home Office who had been anxious previously to encourage donation in prisons.

It was acknowledged that prisons and prisoners differed greatly from one place to another and some Directors felt that a blanket decision to cease visiting prisons would be a mistake. Dr Mitchell in particular felt that it would be unfortunate if such a recommendation was to be included in the "Red Book".

Dr Brookes undertook to circularise the English/Welsh Transfusion Directors and report back to the meeting.^[196]

26.131 A note of the meeting by an SHHD observer recorded that:

The details in Mr Winstanley's minute of 23 August were reported to the meeting of RTDs on 13/9/83.

With the exception of the West of Scotland, RTDs were ceasing collection of blood at prison sessions.

The subject would be kept under review, particularly to hear of developments in England which might be influenced by Home Office views.^[197]

26.132 The UK Blood Transfusion Services' Working Party on Transfusion Associated Hepatitis met on 27 September 1983.^[198] Discussion was dominated by AIDS. In respect of donor sessions in prisons the minutes record:

Members asked if the chairman could provide details of which Centres took donations at Prisons. They realised that the definition of 'prison' ranged from 'closed' to 'open' prisons. The working party felt that prisons should be considered in the context of a 'high risk' population in terms of several of the transfusion-transmitted infections and as such should be avoided as a donor source.^[199]

26.133 The SNBTS Directors met on 8 December 1983.^[200] As regards the Working Party on the Selection of Donors/Notes for Transfusion, the minutes state:

Reporting her consultation with the English/Welsh Transfusion Directors concerning collections in prisons and borstals Dr Brookes explained that only one of the 12 which she had consulted was attending prisons. It was noted that the only Scottish region to continue holding sessions in prisons was the West.^[201]

26.134 On 9 February 1984 a meeting on the infectious hazards of blood products was held at the National Institute for Biological Standards and Control (NIBSC), attended by Professor Cash and Dr McClelland.^[202] There was discussion of AIDS and hepatitis. The minutes note:

The policies adopted in Scotland to minimise the risk of transmission of infection were explained. The three main strategies were 1) avoidance of high risk communities (such as prisons, known homosexual areas, etc.); 2) detection of clinical abnormalities by examination and careful questioning; 3) exclusion of the high risk donor, or his blood, always allowing an 'escape route' for the donor who is deemed unsuitable. Dr McClelland pointed out that it is essential to have well established and well documented procedures in order to carry out these fairly simple strategies.^[203]

26.135 In his evidence to the Inquiry Dr McClelland explained that AIDS 'was on top of everybody's mind at that period'^[204] and led to a 'step change in the rigour of the donor selection procedures'.^[205]

26.136 In July 1984 Drs Dow and Follett produced a Final Report on their study into NANB Hepatitis in the west of Scotland.^[206] The study period had been 1 September 1980 to 31 August 1983. The main aim of the study was to determine whether 'unrecognised viruses are circulating in the Scottish population resulting in cases of hepatitis which at present cannot be categorised' (ie NANB Hepatitis).^[207] A total of 10,655 west of Scotland blood donors had been tested for elevated ALT levels. It was noted that 'screening sessions in prisons detected 10 times more donations with grossly elevated [ALT] levels compared to other sessions'.^[208] The report commented that among the prisoners with high ALT levels, nine were found to be known drug users. In a section of the report on 'Drug Abusers' it was noted that '[t]he vast majority of users with elevated ALT levels admitted being heroin addicts and a considerable proportion were prisoners'.^[209]

1985 onwards

26.137 The Dow/Follett study formed the basis for Dr Dow's PhD thesis, 'Non-A, Non-B Hepatitis in West Scotland', completed in October 1985.^[210] In a discussion on ALT testing of blood donors the thesis commented:

Around one third of those with raised [ALT] levels were known to be drug abusers (ie they did not admit being drug abusers at the time of giving blood, but were found to be drug abusers when specimens were received from them at the HRL)^[211].... It must be assumed that this is a minimum number of drug abusers as many more are known to exist in prisons and many will not readily admit abuse. In a Scottish newspaper (Sunday Post, 1984)^[212] it was reported that Scotland's prisons are now the country's largest drug treatment centres. In 1973 only 6 individuals were diagnosed as being dependent on drugs on admission to prison whereas in 1983 around 300 (6% of the prison population) were drug abusers. These results have led to the [SNBTS] refraining from visiting prisons to obtain blood for transfusion purposes.^[213]

26.138 On 24 March 1986, in a reply to a Parliamentary Question on blood donations from prisoners, Baroness Trumpington, Under-Secretary of State, DHSS, stated:

Regional Transfusion Directors [in England and Wales] have clinical responsibility for the acceptance of blood donors. They do not collect blood from groups known to be at risk from certain diseases.

I am advised that RTDs in England started to phase out collecting blood from prisoners in 1980. Among the factors which they took into account was the large number of donations from prisoners which routine screening for hepatitis showed could not be used. The available tests are not able to screen for all types of hepatitis virus or the presence of the virus in the early stages of the disease. The primary concern of the [NBTS] must be to protect recipients of donated blood.^[214]

Evidence relating to drug use among prisoners

26.139 The chronological review of the evidence available to the Inquiry discloses a belief, expressed from time to time in the later 1970s and early 1980s, and perhaps most clearly by Dr Mitchell in a passage quoted later, that prisoners were 'not in the drug addict class...'. There were drug addicts among paid blood donors, hence their exclusion from donation for example in the USA. There were drug addicts among young adult males, as reported for example by Dr Helske in Finland. In 1972, however, in England and Wales and in Scotland, even among those prisoners who were HBsAg-positive, it appears that none were thought to be drug addicts. A similar picture was presented as late as 1983. There could have been an issue over the classification of an individual as a drug 'addict'. Custodial sentences for possession of controlled drugs, with or without intent to supply, were not uncommon after the commencement of the Misuse of Drugs Act 1972, however, and a frequent plea heard in courts where an intent to supply was admitted or proven, was that the individual had been dealing to 'feed a habit'. Anecdotal evidence suggested that drug use among prisoners might have been a material factor. The belief that prisoners were not in 'the drug addict class' appeared counterintuitive and it was necessary to investigate the official reporting of data.

Annual Reports by the Secretary of State for Scotland

26.140 The Secretary of State for Scotland presented annual reports to Parliament on prisons and other penal institutions in accordance with section 5 of the Prisons (Scotland) Act 1952. The annual reports dealt with various matters including the health of prisoners and the incidence of drug dependency among prisoners.^[215] The reports generally, but not invariably, gave numbers for those prisoners with a continuing dependency on drugs at the time of admission, rather than those prisoners who had ever used drugs intravenously. The reports are therefore likely to have underestimated the numbers presenting risk of transmission of infection for that among other reasons, such as those given by Dr Brookes based on her previous experience.^[216]

26.141 The data returned for the years 1970 to 1985 were:

Table 26.4: Secretary of State's Annual Report to Parliament of recorded cases of dependence on drugs in prisons and other penal institutions

	Hard drugs			Other drugs
Reference period and date	Males	Females	Total
1970: June 1978[217]	[16]		16
1971: June 1978[218]	[16]		16
1972: June 1978[219]	[12]		12
1973: June 1978[220]	[6]		6
1974: June 1978[221]	[6]		6
1975: June 1978[222]	[5]		5
1976: June 1978[223]	21	11	32
1977: December 1978[224]	7	8	15
1978: December 1979[225]	11	8	19
1979: October 1980[226]	5	9	14
1980: November 198[227]	6	12	18	51
1981: August 1982[228]	51	35	86	35
1982: September 1983[229]
1983: November 1984[230]			1163
1984: November 1985[231]			1160
The 1976 report did not distinguish males and females for the earlier years. The 1982 report did not disclose figures but noted 'steadily increasing numbers of admissions ... who have been abusing drugs'.

26.142 The data were not returned consistently and only the broadest of pictures is painted by the totals of all cases.

Figure 26.1: Recorded cases of drug dependence in Scottish Penal Institutions, 1970-1985

26.143 It appears that it was not until the early 1980s that the reports showed a significant and continuing increase in drug dependence among prisoners. In the final two years, growth was exponential. There was no evidence before the Inquiry that the contents of these reports, including in particular the evidence of drug use by prisoners, were shared by the SHHD with the SNBTS. The narrative comment in the reports is instructive as to changing perceptions, however.

26.144 The annual report for 1976 (presented to Parliament in June 1978) commented that all but one of the prisoners dependent on hard drugs were adult inmates.^[232] The 1977 report (presented to Parliament in December 1978) stated that the number of recorded cases of dependence on hard drugs had fortunately not continued to show the marked increase recorded in the previous year.^[233] The 1978 report (presented to Parliament in December 1979) recorded numbers without comment.^[234] The 1979 report (presented to Parliament in October 1980) stated:

Drug dependency diagnosed within Scottish penal establishments, fortunately, does not present a serious problem and there has been little change in the numbers requiring treatment in recent years.^[235]

26.145 The 1980 report (presented to Parliament in November 1981) commented:

The diagnosis of dependence on hard drugs shows little variation over recent years, 18 ... of which 6 ... were males and 12 ... females. However, 51 ... were recorded as dependent on other drugs. There are many more admissions who, if not actually dependent, have a clear history of drug abuse.^[236]

26.146 The impression conveyed to Parliament by the reports to this date was that drug dependence among inmates of penal institutions was not a serious problem in Scotland. Only in the 1980 report was there an indication that the recorded data may not have represented the full extent of the problem of past or current use of drugs by prisoners.

26.147 The 1981 report (presented to Parliament in August 1982) stated:

The large reservoir of hepatitis infectivity in the world is now appreciated and medical, dental and nursing staff in penal institutions are aware of the special risk categories which come under their care.^[237]

....

The increasing misuse of drugs throughout the country is well publicised and prison medical officers are reporting an increase in the number of admissions who have been abusing drugs. There has, this year, been a marked increase in the number of inmates recorded as being dependent on hard drugs such as heroin, 86 ... of which 51 ... were male and 35 ... female. There has, conversely, been a slight fall in the number of cases recorded as being dependent on other drugs, 35 ... 7 ... male and 28 ... female.^[238]

26.148 The 1982 report (presented to Parliament in September 1983) did not provide figures but commented in general terms on the growing problem:

There is no doubt that over the past few years we have seen steadily increasing numbers of admissions to local prisons who have been abusing drugs. These drugs have, unfortunately, usually been hard drugs such as heroin and diconal [a different opioid drug]. In many cases there are obvious signs of self injection and others willingly give a relevant history. This reflects the well publicised, regrettable and dangerous pandemic of drug abuse taking place at present.^[239]

26.149 The 1983 report (presented to Parliament in November 1984) stated:

• The general health of inmates has been satisfactory, but the number who seek medical attention is large and has shown a steady increase over the past few years, almost doubling over the past 10 years ....^[240]
• These rising numbers are not the result of any marked changes in disease pattern, but they do perhaps reflect the increasing number of inmates with personality disorders, with a history of alcoholism and, over the past 2 years, the rapidly increasing number who have been misusing drugs of addiction prior to admission. The psychological and physical morbidity associated with these conditions lead to considerable demands upon medical and nursing staff.^[241]
• Drug Abuse: 490 inmates were recorded as being dependent upon drugs at the time of reception or had recently misused drugs of addiction. The dramatic rise in misuse of narcotic drugs in the UK has been well publicised and this is mirrored in the admissions to our local establishments. Nearly all have been using heroin and most have been multiple drug abusers, involving combinations of heroin, morphine, methadone and sometimes cocaine. Misuse of cannabis, amphetamines and barbiturates is often reported, as is the misuse of dipipanone [another name for diconal] and LSD.^[242]
• Infective Hepatitis:... The incidence of carriers and suspected carriers of Hepatitis B infection in the general community is well recognised and it is realised that penal establishments, with an increasing number of admissions who are drug abusers, will contain their share of possible carriers.^[243]

26.150 The 1984 report (presented to Parliament in November 1985) stated:

• The alarming increase in the use of narcotic drugs in the United Kingdom is mirrored in the number of persons admitted to penal establishments who are identified as having recently used dangerous drugs of addiction. In 1984 some 1160 persons admitted to Scottish penal establishments had been involved in drug abuse compared with 490 in 1983. Almost all had been using heroin, although many had also been abusers of other drugs.^[244]
• Of this number recorded, 935 were males and 228 females. Almost all had been using heroin, although many had also been multiple drug abusers.^[245]
• The increase in the incidence of hepatitis over the past few years is, of course, associated with the increase in intravenous drug abuse. Wherever possible potential carrier states are identified and all sensible precautions to protect staff and inmates are taken.^[246]

26.151 Taken together these reports express the impression conveyed by the figures quoted. They do so particularly in the comments made. They also represent a sudden and rapid increase in the incidence of recorded illicit drug use beginning in the first half of the 1980s. For present purposes there are some obvious concerns about the relevance of the data, especially for the earlier periods. Drug dependency on admission may give a poor indication of a history of relevant drug use up to that point in the individual's life. Reported drug dependency may have been less than actual drug dependency (especially before methadone was readily available on prescription as a substitute for heroin). A drug habit that did not require medical intervention would not have been captured in clinical records. The data appear to have been the best available in official records at the time, however.

Annual reports by HM Chief Inspector of Prisons for Scotland

26.152 The post of Her Majesty's Chief Inspector of Prisons for Scotland was created in 1980 and the Inspectorate of Prisons for Scotland began operations in 1981. The Chief Inspector's 1981 report (presented to Parliament in August 1982) contained no reference to drug use among prisoners,^[247] nor did the 1982^[248] or 1983^[249] annual reports. The Chief Inspector's 1984 annual report (presented to Parliament in October 1985) contained only a brief reference to drug use, in particular in relation to smuggling drugs into prisons during prison visits.^[250]

26.153 On the face of the official records, they appear to give some support for the views expressed by Dr Mitchell and others that until the AIDS era there were no, or at least few, drug addicts in Scottish prisons. With the benefit of hindsight one might question the accuracy and the relevance of the data published and to look at collateral sources of information, such as records of criminal proceedings related to drug use and trafficking for insight into the actual level of use giving rise to the risk of transmission of infection. Later studies were to show that recreational drug use in the United Kingdom increased steadily in the 1960s and into the 1970s.^[251] Given the relatively high prevalence of viral infection among prisoners, this would have been significant information in the 1970s and early 1980s. This was not known at the time, however. Based on the official records, drug use could not be shown to have been a material factor aggravating the risks associated with collecting blood in Scottish prisons. The desirability or undesirability of collecting blood in prisons has to be judged on more general grounds.

Blood supply and prison collections

26.154 As noted earlier, the percentage of total blood donations in Scotland collected from prisons fell from 2.38% in 1975 (5915 of 248,558 donations) to 0.11% in 1984 (342 of 308,617 donations), with an annual average over that period of 1.097%.^[252] In view of the international guidance that need and supply were factors that might affect local choices, a question arises whether an adequate supply of blood could have been maintained had collection from prisons stopped at any time between 1975 and 1984.

26.155 In general, in Edinburgh and the south east of Scotland there was a surplus of red cells, at least in the early 1980s, as a result of the drive to collect plasma for fractionation.^[253]

26.156 In contrast, in Glasgow and the west of Scotland, which accounted for almost one half of all of the blood collected in Scotland, there were problems from time to time, in particular during holiday periods, in collecting enough blood from local supplies to meet clinical demand.^[254] As the evidence of Mrs Prior indicated, prison visits in Glasgow took place principally during holiday periods.

26.157 In a letter dated 30 December 1982 to Dr Mitchell, Professor Cash suggested that any difficulties in ensuring a sufficient supply of blood for cardiac surgery in Glasgow could be met by obtaining red cell concentrates, or even whole blood, from other SNBTS Regional Centres. Professor Cash noted:

Whilst I recognise that figures can be misleading, particularly in the context of fluctuating supply and demand for blood and blood products, the facts are that in the year ending 31st March, 1983 the SNBTS as a whole outdated more than 40,000 donations of whole blood and 35,000 donations of red cell concentrates. It may well transpire that the periods in the year when the West is short and the periods when other regions are short are identical. This topic, however, has not been explored and, in view of the significant potential implications contained in your letter to David Wheatley, I believe the time has come for me to place the matter on the Agenda for our next Co-ordinating Group meeting.

....

Common sense demands, previous experience points to fact, that real co-operation between the Regional Centres of the SNBTS is an essential option that needs to be explored continuously. The public, not to mention the Scottish blood donors, would be disturbed to discover that because of management failings patients in one part of Scotland were suffering because of a lack of blood and in an adjacent city blood was being discarded.^[255]

26.158 However, when the matter was considered at the meeting of the SNBTS Directors' Co-ordinating Group on 22 February 1983, it was noted that Dr Mitchell indicated that he preferred to cope from within his own region.^[256]

26.159 In a letter dated 28 January 1985 to Dr Bell, SHHD, Professor Cash noted that:

The SNBTS currently outdates 30% of its shelvable blood intake (90,000 donations/year). The reasons for this are well known to you - it reflects, primarily, the fact that we are largely plasma driven.

The SEBTS (with the knowledge of the CSA) is now regularly supplying the Edgware RTC [in London] with red cell concentrates.^[257]

26.160 The themes of occasional blood shortages in Glasgow, excess blood products in Edinburgh and Glasgow's communication with other centres arose again in the winters of 1986-87^[258] and 1989-90.^[259]

26.161 By way of explanation for the situation in the west, Professor Cash stated in his written evidence to the Inquiry that:

[I]t is worth pointing out that the annual blood collection figures per million of population in the West was significantly below all other regions in Scotland throughout the 1980s. Thus supply difficulties for red cell was [sic] a not infrequent anxiety for colleagues in the West where poverty and deprivation were significant challenges for those responsible for the blood collection programmes. It is almost certain that it was never a problem for Edinburgh or any other SNBTS region.^[260]

26.162 In his evidence to the Inquiry Dr Mitchell was asked to comment on the particular benefit to the West in collecting donations from prisons. He replied:

Well, it depended at what time of the year. Clearly, every transfusion centre that I have ever worked in has shortages. There is no question that that does occur. It occurs for a variety of reasons. Sometimes it is due to ... holiday times, especially festive seasons, certainly around the West of Scotland. It may also be due to problems with transport, problems with weather and so on. These can easily upset a session or a set of sessions.

So when people are going away or things don't happen then you are left with a major problem and that's one of the reasons that one went to prisons during times when you could anticipate that there might well be shortages.^[261]

26.163 In his evidence to the Inquiry, Dr McClelland was asked whether stopping collection from HMP Saughton caused any problems to supplies in the region. He replied:

It did not, and we would not have expected it to do so because our blood collection programme at that time was firmly driven by the requirement for plasma to be used in the preparation of Factor VIII, you know, in the effort to achieve self-sufficiency with an ever rising utilisation of Factor VIII.

So we actually had a superabundance of red cells. The reason for that is that the majority of the plasma which was provided from our centres to the fractionation plant was collected, at that time, in the form of whole blood from which it was then separated. So we had had a lot of red cells and we shipped the plasma off. Over this sort of period we quite frequently supplied red cells to centres south of the border. We regularly supplied them to one of the London centres for quite a period because we were concerned about ... inappropriate wastage of cells that had been donated.

So it didn't cause a problem in the south east region.^[262]

26.164 Dr Mitchell was asked whether stopping the collection of blood from prisons in the west of Scotland in early 1984 caused any difficulties in respect of shortages of blood and replied, 'I think the answer to that is: yes from time to time. Most of the time one could cope. In fact, pretty well all of the time you could cope'.^[263] Dr Mitchell agreed with the suggestion put to him that stopping collection from prisons did not cause any insurmountable problems with the blood supply.^[264]

26.165 Professor Cash was asked whether a decision in 1975 to stop prison collections in Scotland was likely to have caused any insurmountable problems in the supply of blood. He replied:

[I]t would in my experience have required a little less autonomy, a little more cross-regional support, when times got difficult. But if you take the total input of red cells to the whole of Scotland, I don't believe that 1 per cent would have - we could easily have coped with it.^[265]

The role of government

26.166 It appears that the Home Office favoured the collection of blood in prisons. That seems clear from the minutes of the meeting of the English directors on 26 September 1973,^[266] discussed above, where it was noted that the Home Office should be informed before any action was taken to discontinue collection in prisons, and from the DHSS memo dated 23 August 1983 which referred to the need for close liaison with the Home Office, 'since they have in the past been very much in favour of blood donation by prisoners.'^[267]

26.167 In addition, in her written evidence to the Inquiry Dr Brookes stated that, when she arrived in Scotland in 1981 as Director of the Dundee RTC, she understood, based on her experience working in England, that it was long-standing government policy that the BTS should visit prisons to 'permit prisoners to make some restitution to society' and to 'do something which many of the community did, to help their return to normal life after release'.^[268]

26.168 Dr Graham Scott, former Deputy Chief Medical Officer, SHHD, was asked about the consideration, if any, given by the SHHD between 1975 and 1984 to the practice of collecting blood from penal institutions, the risk of NANB Hepatitis from such donations and whether the practice of collecting blood from such institutions should continue. In his written response to the Inquiry he stated, 'I do not know whether SHHD gave any consideration to this issue; I do not recall being asked to consider it. In any event, I would not have considered it appropriate to interfere with SNBTS practices'.^[269] During his oral evidence to the Inquiry he was asked what he meant by the statement that he would have not considered it appropriate to interfere with SNBTS practices and replied:

I wouldn't have considered it appropriate to question their decisions about taking donations from prisons. I considered them to be excellent scientific individuals and well able to judge what they were doing in their individual circumstances and their individual reason. And in their areas, they would know what was going on. I would not have interfered with that.^[270]

26.169 Despite the evidence that the Home Office in London had been in favour of collecting blood from prisons, Dr Scott was not aware that the SHHD had expressed any views in favour of collection in prisons, which he considered to be 'a matter for the SNBTS Directors'^[271] who were 'in the best position to make informed decisions based on local circumstances'.^[272] He was asked whether, in the 1970s and early 1980s, the SHHD or ministers encouraged donations in prisons and replied in the negative. Dr Scott was also asked whether between 1975 and 1984 he or the SHHD had any view on the practice of collecting blood from prisons. He replied, 'I don't have a view on this. In my opinion, this was a matter for SNBTS'. Nor was he prepared to offer a view on the practice with the benefit of hindsight.^[273] He stated, 'if I had told the SNBTS directors what to do with regard to ... donors selection, I would have been told to mind my own business'.^[274] SNBTS Directors, as Consultants in the NHS, 'were in the position to make their own decisions'.^[275] In Dr Scott's view, the SNBTS Directors could not expect to get a lead from either the SHHD or the DHSS on whether the practice of collecting blood from prisons was acceptable.^[276]

26.170 In his written statement to the Inquiry, the position of Dr McIntyre, Principal Medical Officer (PMO) was similar to that of Dr Scott.^[277] Dr McIntyre stated:

The collection of blood from penal institutions was an established practice by the time I took responsibility for blood policy as PMO in charge of the public health group.

....

I did not take part in any discussions regarding the continued collection of blood from penal institutions. I am not aware of my colleagues having been involved in such discussions. This was really an issue for the Regional Transfusion Directors to address.

....

We knew that SNBTS were running the show and there was felt to be no need for us to interfere. SHHD did not set policy for SNBTS in this area.

....

I do not remember SHHD or Ministers encouraging donations in prisons.^[278]

26.171 In a written statement provided to the Inquiry, Mr John Wastle, an administrative officer in the SHHD, stated:

I was aware that the Home Office had encouraged the collection of blood from prisons in England but I was never aware that the "Home" side of SHHD (which was roughly the Scottish equivalent of the Home Office) had sought to give such encouragement in the 1970s and early 1980s. Similarly, I am not aware that the "Health" side of SHHD or Ministers ever gave such encouragement. My understanding in 1982-83 was that this was an operational consideration for the individual RTC Directors and this, I think, is reflected in the differing positions which they had taken on the issue.^[279]

26.172 Professor Cash was asked whether the SHHD ever sought to influence or encourage the collection of blood in prisons in Scotland and replied, 'No, I'm not aware .... Encouraged? No, I'm not aware. Nor am I aware that they discouraged either'.^[280] He went on:

I would add that there is this strong tradition ... that these matters were under very much the governance of DHSS and I suspect, to be fair to my Civil Service colleagues in Scotland ... that they were waiting for a judgment to come up from London on this and they waited.^[281]

26.173 Professor Cash was further asked who he thought was best placed to consider whether it was appropriate to collect blood from prisons in Scotland. He replied:

In retrospect, I have no doubt it should have been SNBTS but at that time these matters - we broke away eventually in Scotland at that time. These matters, the question of donor selection, were very much in the hands of the DHSS and I think we eventually recognised that this wasn't right.^[282]

26.174 Dr McClelland was asked if he was aware whether the SHHD ever sought to influence or encourage the SNBTS in the collection of blood from prisons. He replied:

I'm not aware of the [SHHD] expressing a view either way, either for or against .... [T]he transfusion directors' meetings were regularly attended by a senior person, a medical person, from the department and they received all the papers and so on. They would have been party to any discussions and would have had ample opportunity to express a departmental view, had they wished to do so.^[283]

26.175 Dr McClelland was asked who was best placed to decide on matters of donor selection policy, the SHHD or the SNBTS, and replied:

I think it probably was primarily an issue for the [SNBTS]. Had there been a view that there was, as it were, a non-medical, like a sociological or welfare reason, to encourage donations in prisons, which certainly is the strand that emerged from the consultations in London, that, I think, would have been an issue for the Department of Health because it certainly is not a health issue for the transfusion service.^[284]

Why prison collections stopped

26.176 In his evidence to the Inquiry Dr McClelland was asked why his region stopped prison collections in 1981. He explained that he had recently spoken with his former regional donor organiser who had reminded him that the donor organiser:

[A]ctually felt it was just an unsuitable environment in total.

It was almost more that concern, plus the specific concerns that really, for lots of very good reasons, we could not rely on getting completely clear transparent answers from prisoners ....

So it would not be correct for me to say that we were worried about hepatitis in the prisons. We were worried about the totality of the environment and I was certainly aware that infection with hepatitis and related viruses was a problem in prisons. I was certainly aware of that information in the United States. So it was a sort of complex of things that led us to this decision.^[285]

26.177 In answer to a question as to whether the concerns of his regional donor organiser centred on it being unfair on the blood transfusion service staff to expect them to conduct sessions in prisons, Dr McClelland replied, 'I think the BTS found it quite a threatening environment'.^[286]

26.178 Dr McClelland also explained that he could find no evidence that a policy decision was taken by his region not to visit prisons again. Indeed, his response to the Medicines Inspectors in January 1983 had been to the effect that while no sessions in prisons or borstals had been held for two years, such collections might be used in an emergency.^[287] He gave the following evidence:

We never did go to prisons again. Having tried to reconstruct this, I find no evidence that we recorded a policy decision that we will stop collecting blood in penal institutions; we just stopped doing it. We informed the contact person, who I think was the Director of Saughton ... that we were not making any further appointments, and in fact we had several representations from them subsequently to come back and run sessions and we did not do that.

I honestly cannot remember now why we did not, as it were, make it a formal policy. I have tried very hard to find any evidence of that, but, as I say, the actions are that we did not ever return and we did not book any further sessions and we never felt any need to do so.^[288]

26.179 In his evidence to the Inquiry Dr Mitchell stated that 'the question that tipped the balance, as far as Glasgow was concerned, was the advent of an incurable disease at that time, called HIV'.^[289]

26.180 Professor Urbaniak decided to attend the collection sessions scheduled, before his tenure, for HMP Craiginches on 7 July 1983 and HMP Peterhead on 28 July 1983. Following his visits he concluded that in the light of the potential for undesirable peer pressure, the potential for an unreliable medical history to be provided and difficulties with confidentiality, the practice should end in the NE region. He also had concerns, on behalf of his all-female donor staff team, at their working in such an environment. No further prison sessions took place in the NE region after 28 July 1983. A cluster analysis, subsequently undertaken by him, revealed both prisons to be HBV 'hotspots'.

Evidence relating to the question whether prison collections should have stopped earlier

26.181 While Dr Gillon was not working in the field of blood transfusion at the time, his impression was that 'the focus on prisons had been largely in relation to Hepatitis B and the feeling was that testing had reached the level of sensitivity that took that off the radar to some extent'.^[290] That appears to have been the position by about 1975 when the third generation tests for HBsAg was thought to have significantly reduced HBV infection among blood transfusion recipients. Relatively sensitive and accurate tests for HBV were beginning to be widely available at that time and tests for HAV soon followed.^[291] Several groups reported in the following year that the majority of patients with clinically diagnosed post-transfusion hepatitis tested negative for infection with HAV and HBV.^[292]

26.182 From 1976 to 1977, the focus began to change towards NANB Hepatitis. However, tests for HBsAg continued to improve. In 1976, there was controversy between Dr Wallace and SHHD over the relative effectiveness of Reverse Passive Haemagglutination and Radioimmunossay, two widely available HBsAg tests,^[293] against a background of growing confidence in the effectiveness of the screening process to reduce, if not totally eliminate, the risk of transmission of HBV. Doubts began to emerge as the investigation of chronic liver disease widened in the later 1970s. For example, the Haemophilia Centre Directors' Hepatitis Working Party report dated 20 August 1978 on the pilot project to investigate the incidence of chronic liver disease in patients treated with Hemofil in 1974-75, expressed doubts about the screening tests for HBsAg.^[294]

26.183 It is necessary to keep a sense of historical perspective in discussing the question of the exclusion of prison donors. A view that might have been taken on the basis of understanding of the accuracy of assays before NANB Hepatitis was known would require revision after that stage.

26.184 Dr Mitchell was asked whether, with the benefit of hindsight, blood should have been collected from prisons in Scotland in the late 1970s and early 1980s and replied:

I don't think there was any major reason not to do it .... It was quite clear that prisoners are human beings. They have a right to give blood like anybody else. It is a civic duty. Many of them felt that it was important that they should do that. Many of them continued when they left prison. Some had been giving before they went into prison. Nothing very much had happened in the interval to suddenly decide against one particular group, it would be difficult to sustain against the idea "Well, why are you discriminating against us?"^[295]

26.185 Dr Mitchell was asked whether the following factors altered his view: namely, the higher prevalence of Hepatitis B in the prison population, the likelihood that the initial Hepatitis B tests did not detect all donations that were positive for Hepatitis B and, in the late 1970s/early 1980s, the emergence of NANB Hepatitis and there being no tests to exclude that disease. He replied:

No, not really. I think the question of the advent of [NANB Hepatitis] was something which was badly understood in the UK. Something which wasn't entirely - the whole epidemiology of it wasn't understood. And whether it would be confined to prisoners who we already knew were not in the drug addict class and so on, like anybody else, we had no reason to believe that they were any different, except for the statement that's made that there were social differences between prisoners, for reasons of close contact with others, incarceration and so on.

....

[NANB Hepatitis] was a diagnosis of exclusion in most cases. There are very few cases in the UK that I was aware of at that time. We seldom got reports from hospitals, "Oh, we have got a case of post-transfusion hepatitis" of any kind. That was unusual. They knew to report that.

....

So I'm sure they would have let us know but they didn't and you would take it, well, it wasn't all that important.^[296]

26.186 Dr Mitchell's evidence on the reported incidence of NANB Hepatitis was similar to the evidence of Professor Hayes. (See Chapter 15, Knowledge of Viral Hepatitis 2 - 1975 to 1985, paragraph 13.34.)

26.187 Dr McClelland joined the SNBTS in 1977 and became a Regional Director in 1979. He was not aware of Dr Yellowlees' letter of 1 May 1975 when he joined the service. His observations on reading the letter later have been set out in paragraphs 26.84-26.85 above. He found the letter surprising but later he qualified that evidence by saying: 'That is a personal view. It says absolutely nothing about what I might or might not have thought about it had I read it 30 years ago ...'.^[297]

26.188 Dr McClelland was asked why he continued to collect blood from prisons until 1981 if he found the advice contained in Dr Yellowlees' letter of 1 May 1975 'surprising' and replied:

I think that we should have stopped. I think we should have stopped sooner. I think it was a matter of focussing on, you know - you come to a complicated new job, you have to decide on which bit of it you are going to focus on and there were many, many preoccupations, like - as will be evident from the medicines inspector's report, the facilities in Edinburgh were deeply unsatisfactory. There was a huge pressure within the organisation. Really the driving pressure within the organisation was collecting plasma to meet haemophilia requirements, and I think that I, as a director there, was slow off to the mark in realising this.

I don't wish to defend that but, as you say, you end up not paying attention to all the potential problems simultaneously. This was one that came a little bit later but I think we responded to it. I think that once we sort of started to think about the issue, it became quickly very obvious that we were going to stop.^[298]

26.189 Later, Dr McClelland was asked whether the collection of blood from prisons had been a real issue for him before his regional donor organiser raised it with him and replied:

I don't think it had. I think I had probably accepted it as the way things were done and probably not directed a great deal of attention to it because I was probably directing my attention to other things.^[299]

26.190 Dr McClelland was asked what his view would have been at the time, had he been asked between 1975 and 1981 whether it was appropriate to collect blood at prisons. He replied:

I think that's almost impossible to answer. I can't unlearn. I mean, what may have happened at that time was I would have consulted my colleagues, as transfusion directors, many of whom had been in post for a long [time] and were highly experienced, and I would have perhaps consulted what, you know, the recommendations from the CMO, or whoever, were. And I might have concluded that, because it was normal practice, because everybody else was doing it and because the CMO said it was fine, I might well have continued - I can't put myself back 25 years in any meaningful way.^[300]

26.191 Dr McClelland gave the following written evidence in respect of the state of knowledge of NANB Hepatitis in 1975:

The importance of the condition [ie NANB Hepatitis] had not at this time been fully appreciated by many concerned with these decisions. Because no causative agent could be identified there was no specific test for NANB and knowledge of the natural history and the epidemiology was lacking. It was not possible to know that individuals could become infected without having evidence of jaundice or indeed any clinical features. Nor could it be known that once an individual was infected their blood could continue to contain the infectious agent for many years in the absence of any symptoms or that some forms of chronic liver disease would eventually be discovered to be caused by chronic infection.^[301]

26.192 Dr McClelland was taken to the international guidance documents discussed earlier and was asked whether the international guidance was consistent or inconsistent with the practice of collecting blood in prisons. He replied:

I think it certainly calls the practice into question, that some of the guidance in these documents would, I think, fairly clearly identify [the] prison population as potentially at least a population from which it is inadvisable to collect blood donations.^[302]

26.193 Professor Cash agreed with five propositions that were put to him. These were that: (i) initially, Hepatitis B screening tests were relatively insensitive in the sense that they did not detect all or perhaps even most positive donors; (ii) there came a point, perhaps around the mid 1970s, when Hepatitis B screening tests were more sensitive and probably did detect most Hepatitis B positive donors; (iii) around that time, there appeared to be a blood-borne non-A, non-B Hepatitis agent or agents; (iv) there was an increased prevalence of Hepatitis B among prisoners; and, (v) Hepatitis B is a blood-borne virus.^[303] Professor Cash was asked whether it followed from these five propositions that there may also have been an increased prevalence of NANB Hepatitis among prisoners and replied, 'I agree that there may have been, yes'. He agreed with the suggestion that these five propositions should at least have given pause for thought in the mid to late 1970s as to whether blood should continue to be collected from prisons.^[304]

26.194 Professor Cash was asked, if one had regard to those five propositions and had paused for thought in the mid- to late-1970s to consider whether blood should continue to be collected from prisons, whether he could say what the likely conclusion ought to have been. He replied:

I find that very difficult to answer .... I really don't honestly know ... in 2011. Again, with the power of the retrospectoscope [ie the benefit of hindsight] I would probably say they should have got out of that and the whole of the transfusion world should have moved, including the commercial people, collecting plasma. But that's a very retrospective view ....^[305]

26.195 Professor Leikola had not seen Dr Yellowlees' letter of 1 May 1975 prior to being asked to assist the Inquiry. On being sent the letter and asked for his comments he replied:

To me, when I read this particular paragraph here on prisons, I agreed with the first sentence. I also agreed with the second sentence that there are various groups with high risks that are extremely difficult to identify. But somehow I don't see that this fact that we can't identify some risk groups would lead to the decision that one group that we can identify should not be excluded from the donor pool. This means that if there are a number of things that we can't do, that doesn't mean that if there is something that we can do, it should not be done. If that group can be clearly identified, as stated here, the prisoners were a group with risk.^[306]

26.196 Professor Leikola confirmed that the introduction of more sensitive Hepatitis B screening tests around 1975 did not alter his opinion that a donor group which was known to carry a greater risk of Hepatitis B should still have been avoided.^[307] He was asked whether this was an area in which different experts could reasonably hold different views or whether he considered that it simply would not be a reasonable view that collection in prisons should continue. He replied:

I think that the meaning of introduction of a more sensitive test was interpreted differently by different countries, notably in France, the donations in prisons continued and therefore I think that experts could interpret this differently. However, in the light [of] what was known at that time about Hepatitis B and possibly other viruses, I think this advice of, "Yes, go ahead with prison donations", was probably not correct.^[308]

26.197 He went on:

I would refer to the practice in Finland, where we decided to stop that because the significance of prison donations ... to the blood supply was not significant and therefore we decided to, so to say, play safe and therefore from our perspective this particular recommendation, "Yes, go ahead with prison donations", was not reasonable.^[309]

26.198 Professor Leikola was asked a number of specific questions relating to this topic, which are best set out in turn:

• Asked whether he considered that the practice in Scotland of collecting blood in prisons ought to have been reconsidered at any point in the 1970s or early 80s, he replied:

  I think my feeling is that the matter should have been taken on the table and discussed in a logical way. Seeing what are the cons and pros of continuing this long practice .... However, the impression that I have received from reading these different documents that you sent me is that this matter was really not taken into serious consideration during the late 1970s up until 1981 and of course then 1983.

  So my impression - and this is just my impression from reading these documents - is that this tradition went on without really being seriously considered whether it should now be stopped because of various facts that had been published during the 1970s.^[310]

• Asked what the conclusion ought to have been had the matter been considered in the 1970s and early 80s, he replied:

  In my opinion, that should have been stopped, not necessarily ... from one day on, but sort of faded away, so that it would not have caused very much publicity and the impression of not taking prisoners as human beings. But the conclusion would be that I think it would have been reasonable to stop this old practice.^[311]

• Asked whether it was reasonable to continue the practice in the 1970s and early 80s, he replied:

  In these circumstances, where, if I'm not mistaken, it was not seriously discussed, then I think that it was reasonable to understand that it went on, even though in my opinion it should have been seriously discussed and then made the conclusion that, no, it's much better not to go to prisons.^[312]

• Asked, given that Hepatitis B and NANBH were considered to be blood-borne viruses and studies had shown a higher prevalence of Hepatitis B among prisoners, whether could one reasonably have predicted in the late 1970s that there might also be an increased prevalence of NANBH among prisoners, he replied:

  At least in retrospect one would say that one could have seen this connection and drawn that kind of conclusion.

  ....

  Just because it appeared then, on the basis of the American studies, that the non-A non-B, at least in 1977/78, is a blood-borne virus or viruses and very likely to be a virus. So if Hepatitis B is a blood-borne virus, then it is reasonable to think that the inmates would have also higher prevalence of this new, unknown virus.

  ....

  Because the ways of acquiring the virus seemed to be quite similar.^[313]

• Asked, given that the initial understanding was that NANB Hepatitis was a clinically benign disease, whether that was a material consideration when deciding whether collection in prisons should continue, he replied:

  I think that it influenced, in the background, the decision.

  ....

  But once it became clear that it is a blood-borne virus and so on, and as was shown in the late 1970s, that indeed it does cause disease and this disease is not necessarily mild, then I think that in a case where there is a possibility to prevent that, even if the measure is not very effective but still if that is possible, then I think it should have been done.^[314]

26.199 Dr McClelland was asked whether there were any lessons that could be learned going forward. He replied that various expert groups had been formed which had worked extremely hard to be aware of information about new or emerging infections and populations at risk and to push for action to be taken quickly. He went on:

What I think is much more difficult is to deal with the problem where you have within a community, a professional communal, a sort of very powerful sort of dome of received opinion, which is sitting over everybody and they have a belief system that this isn't a problem. And therefore even when perhaps some individuals sort of stand up and make a noise and say, "I think there is a problem", there is a very good history of you know, people who actually do see a little bit further ahead, clearly not being - actually they seem to be a nuisance because they get in the way of what we are doing at the moment, and that's really a sort of sociological problem, I'm sure not unique to blood services and it is actually very difficult to deal with.

So I think that the best that we can do ... is wherever possible to encourage attitudes that permit and encourage questioning of things that "everybody knows" and more specifically to look at the mechanisms that we have now and that would include the ... advisory committee on the safety of blood ... the national body charged with informing the ministers of health for UK countries about precisely this type of issue, and try to see that that group is well supported, well resourced, has access to the best intelligence, the best connections for picking up, assessing the importance of things and then making a big noise about it so that somebody does something.

I think these are not exactly revolutionary mechanisms but I don't know that I'm in a position to invent any better solutions. Challenging the received wisdom - because no doubt the received wisdom in the UK was that these things weren't a problem. We were okay because we didn't have paid blood donors and somehow that just made everybody feel - I think it would not be unfair to say that there was a slight sort of sense of superiority because we didn't have paid blood donors in the UK. And that may well have been a factor that sort of blinded people to the fact that we need to look at the totality of our donor populations and be sure that we were sensitive and aware of where perhaps there were risks that were greater and should be seriously questioned.^[315]

Evidence in respect of the incidence of Hepatitis C among drug users and prisoners following the availability of Hepatitis C tests

26.200 As discussed elsewhere in this Report (see Chapter 16, Knowledge of Viral Hepatitis 3 - 1986 Onwards and Chapter 31, The Introduction of Screening of Donated Blood for Hepatitis C), the Hepatitis C virus (HCV) was identified in 1988, scientific details of the discovery were published in 1989, tests for HCV subsequently became available and screening of all blood donors for HCV was introduced throughout the UK in September 1991. In short, once tests for HCV became available, studies showed a higher incidence of HCV among those who injected drugs and a higher incidence of HCV among prisoners compared with the general public.

26.201 In Scotland, all blood donors who were found to be infected with HCV in the first six months of routine testing of all donations for anti-HCV were followed up. Of those HCV-positive donors, intravenous drug use was found to be the most common risk activity (in 39% of the HCV positive donors).^[316]

26.202 In 1999 Dr Sheila Gore and others reported on a study carried out between 1994 and 1996 into the incidence of Hepatitis C among prisoners in five Scottish prisons.^[317] Overall, the study found a prevalence of antibodies to Hepatitis C in 20% of inmates, with a prevalence of anti-HCV in 49% of inmates who reported having injected drugs and a prevalence of 3% in inmates who reported not having injected drugs. The study also found that those who began injecting in 1992-96 were less likely to be positive for anti-HCV than those who started before 1992 (31% compared to 55%).^[318] The paper noted that:

International data, including from Scotland, suggested that between 60% and 90% of injectors might have hepatitis C antibodies, with between 50% and 90% of them being also RNA positive.^[319]

26.203 In 2002 Dr M. Adekoyejo Balogun and others reported on a study to 'estimate the background population prevalence of hepatitis C in England and Wales, observe the prevalence over time and assess the extent of infection outside of known risk groups'.^[320] In the study, residual sera from samples sent to laboratories for routine diagnostic examination in 1986, 1991 and 1996 were tested for the presence of antibodies to the Hepatitis C virus (anti-HCV).^[321] Testing of the serum samples in each of the years gave an estimation of the overall anti-HCV prevalence in the general population of 1.07% in 1986, 0.55% in 1991 and 0.70% in 1996.^[322] Having regard to the HCV genotype^[323] distribution in the study samples, the authors considered that their findings were 'consistent with the majority of infections having been acquired by injecting drug use'.^[324] In the discussion section the authors commented:

Most of the HCV infections in the population studied in this survey were probably acquired before 1986, mainly amongst people born between 1946 and 1970. The low prevalence in the more recent birth cohorts, implies that the incidence of HCV infection has declined. This epidemic is probably primarily associated with acquisition of HCV through injecting drug use. Seroprevalence studies both in the UK and Europe have found prevalence levels ranging from 50% to 90% in injecting drug users and the importance of drug use as a major risk factor for infection has been well documented. The use of recreational drugs in the UK increased steadily during the 1960's and into the 1970's. During this time, non-therapeutic heroin misuse emerged in London and spread to neighbouring counties. More widespread injecting of other illicit drugs, such as barbiturates, also increased during this period. The age profile of persons now presenting with HCV liver complications who have acquired HCV through injecting drug use reflects these historical patterns of injecting drug use.^[325]

Other possible higher risk donors - the collection of blood from US military personnel in Scotland

26.204 The suggestion that the Inquiry should address the position of US military personnel as 'higher risk' donors was raised in correspondence from Messrs Thompsons, the solicitors acting for the patients, relatives and Haemophilia Society core participatants, on 18 March 2011.^[326]

26.205 The Inquiry did not discover any research conducted in Scotland. As noted above (paragraph 26.66), an early English study (in 1972) found that there were no antigen or antibody positive results found - hence prevalence was 0% - on testing armed forces donors, including US Air Force personnel. Technology was not well developed at that time but the results offered some reassurance that there was no significant problem in this population.

26.206 The Inquiry received evidence that blood was collected from US military personnel in Scotland at RAF Edzell between 1963 and 1996 and from the US naval base at Holy Loch from an unknown date until 1990.^[327]

26.207 The number of donations collected at RAF Edzell is shown in the following table:

Table 26.5: Collection of Blood at RAF Edzell by the East of Scotland Regional Transfusion Centre (Dundee)

Date	No. of donations	Date	No. of donations	Date	No. of donations
09.04.1963	73	13.05.1975	214	26.02.1987	320
14.11.1963	92	10.11.1975	201	14.09.1987	237
07.05.1964	67	17.06.1976	217	01.02.1988	233
10.12.1964	105	03.12.1976	197	07.06.1988	207
20.05.1965	79	07.06.1977	214	28.02.1989	201
07.04.1966	93	08.11.1977	243	22.06.1989	240
27.10.1966	137	13.06.1978	221	27.02.1990	164
04.05.1967	120	14.11.1978	179	14.06.1990	312
12.10.1967	108	17.05.1979	160	06.11.1990	241
14.05.1968	124	30.10.1979	119	18.04.1991	212
10.10.1968	164	17.06.1980	157	15.10.1991	159
01.05.1969	178	28.10.1980	198	03.03.1992	162
17.11.1969	146	19.05.1981	185	23.07.1992	120
21.05.1970	219	22.10.1981	174	02.02.1993	190
24.11.1970	228	06.05.1982	172	28.09.1993	110
25.05.1971	234	15.11.1982	162	07.04.1994	150
09.11.1971	194	26.05.1983	198	17.10.1994	254
30.05.1972	129	31.10.1983	266	06.06.1995	183
14.11.1972	231	28.06.1984	183	05.10.1995	135
26.04.1973	139	20.11.1984	175	27.02.1996	117
13.11.1973	191	11.07.1985	143
14.05.1974	132	13.03.1986	280
12.11.1974	206	02.09.1986	262	Total	11,856

26.208 The number of donations collected from the US naval base at Holy Loch is shown in the following table:

Table 26.6: Collection of blood at the Holy Loch US Navy base by the West of Scotland Regional Transfusion Centre (Glasgow) 1982-86; 1989-90

Date of session	Number of donations
21.10.82	179
10.03.83	119
07.10.83	166
08.03.84	165
04.04.85	102
02.10.85	61
19.05.86	16
13.02.89	142
14.02.89	245
21.02.90	71
22.02.90	131

26.209 Between 1982 and 1990, an approximate average of 600 donations a year was collected from US military personnel in Scotland. There were approximately 300,000 donations collected annually in Scotland during that period.^[328] The donations collected from US military personnel in Scotland between 1982 and 1990 therefore represented approximately 0.2% of the total number of donations collected annually in Scotland.

26.210 The Inquiry has also considered whether there was evidence to suggest that blood collected from US military personnel in Scotland carried a higher risk of transmission of NANB Hepatitis/Hepatitis C. Reference has been made to some data collected by the Transfusion Directors in the early 1970s. On a more general level, the Inquiry's attention was drawn to three papers in that regard that were suggested to have particular relevance.

26.211 The first relevant source of information was a paper by Albert Sabin on the incidence of viral hepatitis among US military personnel published in 1976 in the Yale Journal of Biology and Medicine.^[329] While the author concluded that the incidence of reported cases of icteric viral hepatitis (hepatitis, that is, associated with clinical observation of jaundice) was much higher in US military personnel than in comparable age groups in the civilian population, the author went on to state that the preliminary data strongly suggested that Hepatitis B (rather than Hepatitis A or the 'hypothetical' Hepatitis C) was the predominant viral cause of hepatitis among US military personnel throughout the world and that sexual promiscuity, rather than drug use, appeared to be a more likely explanation for that higher incidence.^[330] The paper did not suggest or establish that US military personnel stationed in Scotland were likely to have a higher incidence of NANB Hepatitis than in the general population.

26.212 Secondly, a paper by Kenneth Hyams and others on viral hepatitis in the US navy was published in the American Journal of Epidemiology in 1989.^[331] The authors reported that, from 1974 to 1984: total first hospitalisations of US naval personnel for viral hepatitis declined, that there was a significant decrease in the incidence of confirmed cases of Hepatitis B and NANB Hepatitis and that the incidence of confirmed cases of Hepatitis A increased after 1980 when a commercial serologic test for acute Hepatitis A became available.^[332] During each of the 10 study years, confirmed cases of Hepatitis B were the most frequent hepatitis diagnosis overall. Again, the study did not suggest or establish that US naval personnel stationed in Scotland were likely to have a higher incidence of NANB Hepatitis than the general Scottish population. Indeed, because the study was based on hospital admissions for cases of acute hepatitis and it is now known that most cases of Hepatitis C are non-icteric, the cases of viral hepatitis in the study are more likely to have been caused by Hepatitis A or Hepatitis B than by Hepatitis C.

26.213 Finally, there was a short article by Michael D Parkinson and others on viral hepatitis in the US Air Force in the period 1980-89, published in the journal Vaccine in 1993.^[333] It is apparent that no meaningful conclusions can be drawn from the very brief narration of the results of the study reported in the article. In any event, the article was published at a time when all blood collected by the SNBTS, including blood collected from US military personnel, was screened for HCV.

26.214 In summary, the amount of blood collected from US military personnel in Scotland was minimal (about 0.2%) compared with the total amount of blood collected in Scotland. In addition, the Inquiry is unaware of any evidence to suggest that the SNBTS, the UK Government or any responsible Scottish agency knew or ought to have known during the 1970s or 1980s that blood collected from US military personnel in Scotland carried a higher risk of transmitting NANB Hepatitis, Hepatitis C or, indeed, HIV than blood collected from the general donor population.

Discussion

Use of drugs

26.215 As indicated in the first part of this chapter, a current or recent history of injecting drugs, or physical evidence of having injected drugs, were seen throughout the reference period as grounds for deferment from donation for specified periods, or for exclusion from donation altogether. While the general policy may have been clear as it evolved from time to time, prior to 1983 the SNBTS did not provide uniform directions or recommendations for Regional Transfusion Directors and their staff to ensure, as best might be achieved, the application of that policy, for example, by asking prospective donors directly about drug use and/or including a question to that effect in the health check questionnaire.

26.216 With the passage of time, oral evidence of practice in the 1970s and early 1980s is inherently unreliable, especially in the case of Regional Transfusion Directors and more senior officers of the SNBTS who would not, in the general run of things, be involved regularly in routine donor session work. However, the evidence on this matter does tend to suggest that direct questioning of the donor on their drug use may not then have been routinely used as a means of enforcing that policy. That evidence is limited. Mrs Prior ceased working as a MTA in the west of Scotland in 1974. Dr Mitchell thought that there was no questioning on injecting drugs in the 1970s but thought that it might have come in later in the consideration of AIDS. Dr McClelland was only confident that the majority of the staff would have questioned donors about drug use from the early 1980s onwards.

26.217 Observation by donor session staff, short of a thorough and structured examination backed up by relevant and detailed questioning, might not have uncovered the full extent of intravenous drug use among prospective donors. The 1971 WHO Guide seems to have been excessively optimistic in suggesting that medical officers should be able to pick out 'drug addicts' in distinguishing acceptable from unacceptable donors. However, it may have envisaged a more thorough medical examination than typically happened in Scotland in the 1970s.

26.218 In any event, injection of controlled drugs by a donor might have ceased long before the examination and have left no surviving traces either on the donor's body or in their behaviour. As was to become clear after tests for Hepatitis C became available, infection could remain asymptomatic, but transmissible, for decades in individuals who had ceased to be IVDUs and who may never have been addicted to intravenous drugs. The true nature of the risk was not known in the 1970s and early 1980s.

26.219 The principal guidance available to the Regional Directors of the SNBTS prior to 1983 appears to have been the 1977 Memorandum on the Selection, Medical Examination and Care of Blood Donors. Until the arrival of AIDS, neither international nor UK produced guidance seems to have contained any explicit advice emphasising the need to question blood donors about their drug usage, in particular, any intravenous drug usage. In June 1983, the South East BTS introduced donor questions about risk factors including intravenous drug use and by early 1984, at the latest, this had become SNBTS practice. Professor Juhani Leikola of the Finnish Red Cross Blood Transfusion Service confirmed that the donor questionnaires used in Finland in the late 1970s/early 1980s did not include a question as to whether the donor had ever injected or used drugs. He also indicated that it was not until 1983 when 'AIDS came into the picture' that questioning of donors about intravenous drug use started in Finland. The numbers of those who were drug dependent within prison and other penal institutions remained relatively stable until the early 1980s. The upward trend in drug use outside such institutions was modest until 1980. In and after 1981 the rate of growth in drug abuse accelerated.^[334] This may also assist in explaining the relative lack of emphasis on the questioning of donors up until the early 1980s. A number of the Regional Directors were concerned about the sensitivities of the donor population and this was, plainly, a legitimate consideration given that the blood supply depended upon voluntary donation. In both Finland and Scotland AIDS seems to have been the catalyst for the introduction of the routine questioning of donors about the injecting of drugs.

Prisons and other penal establishments

26.220 By the mid-1970s there was some international guidance tending towards advice that blood should not be collected for transfusion from those detained in penal institutions. It was emphasised, however, that decisions on the designation of high risk groups was a matter for local decision in the light of circumstances obtaining from time to time and having regard to the need for and availability of blood. As noted at the beginning of this chapter, international practice varied widely in respect of collecting blood from penal institutions. National circumstances clearly varied considerably. The policy and practice in Scotland must be considered in the light of local circumstances here.

Responsibility for policy

26.221 When, at a meeting on 26 September 1973, the incidence of Australian antigen in prison donors was reported to be higher than in the general public, the English and Welsh Regional Transfusion Directors agreed that, if it were decided to discontinue accepting blood donations from prisoners, the Home Office should be informed before any local action was taken.^[335] There is, however, no evidence that there was a similar concern within the Scottish administration at the time. As discussed in Chapter 17, Blood and Blood Products Management, policy was a matter for ministers and their civil service advisers.

26.222 The letter dated 1 May 1975 by Dr Yellowlees, referred to earlier, was a clear example of government giving advice on donor selection, at least in England and Wales. Equally, Dr Wallace's comments in his 1977 publication, that it was socially and psychologically undesirable to exclude prisoners from the donor population, acknowledged that the collection of blood required to be seen not only in the context of the adequacy and safety of the blood supply. He referred to the role of blood donation in prisoner rehabilitation, observing that some prison donors became regular volunteers after their release. The DHSS document, published in 1979 and applicable throughout the UK, Standards for the Collection and processing of Blood and Blood Components and the Manufacture of Associated Sterile Fluids, also provided government advice on this matter. Dr Brookes' experience in London before moving to Dundee in 1981 had informed her that it was long-standing UK Government policy that the BTS should visit prisons to permit prisoners to make some restitution to society and to do something, which many in the community did, to help their return to normal life after release. Dr McClelland's evidence that the Director of HMP Saughton made several representations to the Edinburgh and South East of Scotland BTS to return to the prison and resume sessions after Dr McClelland had terminated the practice in 1981, indicated in a practical way that the rationale for the practice included policy relating to prison management rather than exclusively to SNBTS management.

26.223 The wider policy aspects of the question were clearly recognised by the UK government. The minute sent by Mr JB Brown, Medicines Division, to his DHSS colleagues on 27 July 1983 on the use of blood from prisons, sought departmental guidance on the issue at the request of the Medicines Division's Inspection Action Group.^[336] Mr Winstanley commented on the need to consult the Home Office in view of the importance placed on the social responsibility aspect of prison sessions. The SHHD manuscript file note dated 11 August 1983 recorded the outcome of Mr Winstanley's contact with the SHHD in respect of the Medicines Inspectorate's query.^[337] It recorded that the situation in Scotland would be kept under review, 'particularly to hear of developments in England which might be influenced by Home Office views'.

26.224 By the date of his minute of 23 August 1983, quoted in paragraph 26.128, Mr Winstanley had clearly identified the problem presented by the risk of transmission of AIDS. His view reflected the position common at the time, that it was difficult to advise on Departmental policy on the collection of blood from borstals and prisons since it was for individual Regional Transfusion Directors to determine how and from where donations were sought. However, his observation on the need to liaise closely with the Home Office underlined the wider policy issue. The Home Office had in the past been in favour of blood donation by prisoners as an aspect of policy unrelated to the risk of transmitting disease. It was clearly understood at the meeting of SNBTS Directors on 13 September 1983 that the DHSS would wish to consult the Home Office on account of that department's previous wish to encourage donation in prisons.^[338]

26.225 The letter dated 1 May 1975 by Dr Yellowlees referred to earlier was a clear example of government giving advice on donor selection, at least in England and Wales, as was the document published by the DHSS in 1979 and applicable throughout the UK, on the Standards for the Collection and Processing of Blood and Blood Components and the Manufacture of Associated Sterile Fluids. The intervention of the Medicines Inspectorate in 1982 clearly had an impact on the thinking of the Working Party on the Selection of Donors. Among other considerations, it undermined further the notion within the SHHD that the selection of donors was wholly a matter for transfusion directors.

26.226 It is implicit that there will be issues affecting the portfolios of more than one government Minister or, in the case of Scotland before devolution, more than one department of the Scottish Office. Resolution of any differences of substance was ultimately a matter for political office holders rather than officials. The exchanges between UK departments were appropriate. However it was arrived at, the decision communicated by Dr Yellowlees in May 1975 removed from the NBTS direct responsibility for continued prison collections, notwithstanding the relatively high risk of transmitting Hepatitis B.

26.227 Dr Wallace's view was not a policy consideration for the SNBTS. The social factors that entered into the debate - whether it was socially or psychologically desirable to exclude prisoners, whether blood donation assisted rehabilitation and similar formulations - were issues for government. In deciding on social policy, it was for ministers to determine whether the incidental benefits to prisoners of giving blood should prevail over risks to the safety of recipients of the blood. That would have required advice on whether there was a risk and, if so, on its magnitude. Social cost and benefit might not have been easy to balance, though the safety and well-being of NHS patients would on any view have been a high priority. It was clearly, however, not a matter for a transfusion specialist such as Dr Wallace to decide. The emphasis in the documents on the views of the DHSS was a reflection of the political reality: collection in prisons was not exclusively a matter appropriately devolved to technical specialists. It engaged wider social values and was properly a matter for ministers and government policy.

26.228 If that was recognised at UK level, it was appropriate that it should be recognised at local level in Scotland. As set out in Chapter 17, Blood and Blood Products Management, paragraph 17.20, it was the statutory duty of the Secretary of State for Scotland, and now the Scottish Ministers, to provide effective health care in Scotland, including promoting the effective provision of blood transfusion services, and the Scottish Ministers have operational control of health care policy. The CSA had delegated responsibility for the operational management of blood services but was subject to, and obliged to act in accordance with, such directions as might be given by the Secretary of State. Devolving management responsibility to the CSA could not remove ultimate responsibility from ministers for wider social policy.

26.229 The evidence of Dr Scott, Dr McIntyre and Mr Wastle, that it was for SNBTS Transfusion Directors to deal with the issue, to the extent that they did not know whether the SHHD had ever considered it, was clearly a true reflection of officials' attitude at the time and is accepted as a reliable account of their own views and practices. While there is evidence that the Home Office in England and Wales encouraged donations in prisons, there was no evidence before the Inquiry that the SHHD encouraged donation in prisons in Scotland. Instead, the SHHD took a passive role, noting without demur Dr Yellowlees' letter dated 1 May 1975 and otherwise leaving it for the SNBTS to decide whether prison collection was appropriate.

26.230 The Regional Transfusion Directors were an appropriate group to advise government on the medical and technical aspects of this question. Individually they may have held different views on the answer from time to time but the Inquiry heard no evidence that would have cast doubt on their competence to assess risk according to the standards of the time and to contribute to the debate. It was not, however, the appropriate group to advise on, much less to determine, the social issues raised. On the other hand, there was no evidence before the Inquiry that the SNBTS Directors advised the SHHD of any concerns regarding collection from prisons.

When and how was the issue raised?

26.231 It is appropriate for the Inquiry to discuss the questions that arise in relation to timing and the presentation of the issue of prison donations with reference to relevant medical and technical aspects.

26.232 Regional Transfusion Directors were free to follow their own practices. Dr McClelland's decision in 1981 to discontinue prison sessions was prompted by the views of the regional donor organiser.^[339] Her reasons - related to the threatening prison environment, the difficulty of obtaining clear, transparent answers and other social factors - would have been of similar weight in any region. Dr McClelland responded to her views without reference to other Regional Transfusion Directors, a clear example of the exercise of the local autonomy that characterised the service at the time. Similarly, Dr McClelland received, but did not respond positively to, representations by the Director of HMP Saughton to return and run further sessions. It would not be appropriate to draw general conclusions relating to other regions from the timing or circumstances of his decisions. They were not prompted by apprehensions relating to transmission of infection and they were not supported by any well-formulated policy.

26.233 Dr Brookes was opposed to prison collections before she came to Scotland and clearly articulated her concerns after she arrived in Dundee in 1981. After she took up her post, she vetoed a proposal for additional prison sessions. The last prison session in her region was 2 August 1983. She deliberately raised her concerns with the Medicines Inspectors and was well informed of the practice of her Welsh and English colleagues. After the meeting on 29 March 1983 Dr Brookes asked the organising secretary in Dundee to phase out prison and young offenders' sessions over the coming year, accommodating the Centre's programme of donor sessions which was generally confirmed one year ahead.^[340]

26.234 It is clear from Dr Brookes' evidence that it was at the meeting on 29 March 1983 that it became evident to her that, although the Directors were divided, individual Directors who wished to discontinue prison sessions could do so. At that same meeting Professor Urbaniak had indicated that he intended to review the situation in his region and, like Dr Brookes, he concluded that the practice was undesirable and terminated it. It seems reasonable to conclude that for the Scottish regions as a whole, excluding Edinburgh and the South East, the issue became live in March 1983. By then, the Directors were, effectively, solely responsible for implementing their individual decisions and discontinuing or not according to their individual assessments of the needs of their regions.

26.235 As in other areas, Professor Leikola's insight into the position up to that point was helpful. There had been a long standing practice of collecting blood in prisons. He said:

[T]he impression that I have received from reading these different documents that you sent me is that this matter was really not taken into serious consideration during the late 1970s up until 1981 and of course then 1983.

So my impression - and this is just my impression from reading these documents - is that this tradition went on without really being seriously considered whether it should now be stopped because of various facts that had been published during the 1970s.^[341]

26.236 Once the equilibrium in a static society is disturbed, the potential for change may be unlimited. Disturbing the established position is not necessarily easy, however. Dr McClelland's observation was pertinent. Again, as noted above, he spoke of:

[T]he problem where you have within a community, a professional communal, a sort of very powerful sort of dome of received opinion, which is sitting over everybody and they have a belief system that this isn't a problem. And therefore even when perhaps some individuals sort of stand up and make a noise and say, "I think there is a problem" ... actually they seem to be a nuisance because they get in the way of what we are doing at the moment, and that's really a sort of sociological problem, I'm sure not unique to blood services and it is actually very difficult to deal with.^[342]

26.237 The difficulty of challenging the status quo of entrenched opinion perhaps explains most cases of prolonged practices after they are or should be challenged. One can exclude conspiracy: there was no decision to continue to accept donations in the face of contrary indications. The practice simply continued until it stopped.

Should the practice have been discontinued earlier than it was?

26.238 On the evidence there is an obvious question whether prison collections were at all necessary in the reference period to secure the blood supply. The issue relates to demand for blood components and in particular for red cells. Packed red cells were produced in the course of preparation of plasma for fractionation at PFC and surplus production was sent to England. The preference in the west of Scotland appears to have been for blood components produced locally (mainly at Law Hospital) and that provides the principal context for discussion.

26.239 Prison collection was not necessary in Edinburgh and south east Scotland: discontinuation of the practice caused no supply problems. The dedication of a high proportion of whole blood collections to the preparation of plasma for supply to PFC ensured an ample supply of red cells for surgical and other medical applications. Apart from some very general observations that there were occasional shortages during local holidays and other periods for example, the only region that consistently sought to justify prison collections on supply grounds was the west of Scotland.

26.240 It has to be accepted that there were occasional issues over supply in the west of Scotland but it cannot be accepted that that those problems were necessary (or, at least, insurmountable). Professor Cash's observation on this issue is pertinent: it would have required a little less autonomy and a little more cross-regional support when times got difficult. Given the total input of red cells in the whole of Scotland, the loss of prison donations could easily have been coped with.^[343] The continued practice cannot, on the evidence, be justified on the grounds that without prison donations there would have been shortages of red cells for surgical or other medical applications that could not be made good from Scottish sources. Dr Mitchell's comment that he preferred to cope from within his own region^[344] was at odds with the need for more collaborative working.

26.241 The impact of the AIDS epidemic finally led to a change of mind in Glasgow and the west of Scotland.^[345] The risk of transmission of HIV 'tipped the balance' as far as Glasgow was concerned. Implicitly, the risk of transmission of Hepatitis B and NANB Hepatitis had not tipped the balance and collections did not cease until 25 March 1984, about the time of Dr Gallo's publication of the discovery of HTLV-III. (See Chapter 11, HIV/AIDS Aetiology.)

26.242 There was ample evidence before March 1984 that Hepatitis B and NANB Hepatitis presented threats to recipients of blood, blood components and blood products. In the case of Hepatitis B, there was ample evidence that there was a relatively high prevalence of infection in the prison population. The paper by Dr Wallace and colleagues published in March 1972 represented a major advance in the collection and analysis of relevant data: overall, the incidence of Hepatitis B positive donations among prison donors (0.65%) was just under seven times higher than that in the general public (0.10%). The English and Welsh Directors' researches yielded similar data when they completed their exercise in July 1974: in 1973 the incidence of Hepatitis B antigen in new general public and factory donors was 0.09% whereas the incidence of Hepatitis B antigen in donors in prisons, borstals and similar institutions in 1973 and Jan-March 1974 was 0.43%.^[346] The validity of the data did not depend on whether prisoners were drug addicts or how they came to be infected. The numbers defined the relative seriousness of the problem prison donors presented. The Dow/Follett report of July 1984 showed that raised ALT in the prison population was ten times the incidence found in the general population.

26.243 In earlier chapters of this Report, the Inquiry has discussed:

• The effectiveness of basic collection procedures to identify the risks presented by potential donors. The discussion showed that the procedures were not effective in the case of a person unwilling or unable to provide information on the risks arising from his or her medical history, such as a history of hepatitis/jaundice or blood transfusion. They were equally ineffective in the case of a person with a past or current history of injecting drug use who was unwilling to disclose that practice and who either did not have signs of current drug use or had taken pains to conceal track marks from investigators.
• The effectiveness of screening technology to identify blood that presented risk of transmission of infection. HBsAg screening was very ineffective until the mid-1970s in identifying blood infected with Hepatitis B. It was totally ineffective in identifying blood infected with NANB Hepatitis.

26.244 If it is known that there is a real risk of transmitting serious infection; that identification of that risk as presented by donors is beset by procedural and technological problems; and that a particular group presents risk of transmitting infection of an order of magnitude greater than the general population, there appears at first blush to be good reason to avoid that population.

26.245 The position is complicated by a number of factors, however. HBsAg assays were initially very ineffective: a detection rate of 25-30% would have suggested that a population with a relatively high prevalence of infection should have been avoided. The tests became more efficient with time, however, and that factor became less significant.

26.246 The issue was thought to have diminished by the mid-1970s. Dr Yellowlees' letter of 1 May 1975 shows the official UK response to the perception of risk at that stage, when confidence in screening for HBsAg was at its peak.

26.247 There were, however, good scientific and medical grounds for terminating prison collections by the early 1980s. The time frame for consideration of the issue is defined roughly by these dates. By the early 1980s concerns about prison collections were being articulated by Directors such as Dr Brookes and they were probably shared by Professor Cash and others. Dr McClelland acted alone in not collecting blood from prisons in his region after December 1981: others might have taken a similar step. There was still no consensus even in 1983. The role of a specialist service such as the SNBTS was to express a view that might have persuaded government to act. While the SNBTS could not alter UK Government policies understood to be in place that were opposed to termination on social or rehabilitation grounds, it would have been reasonable for the SNBTS to have formulated a collective view for communication to the SHHD on whether there were medical and scientific reasons to suggest that the continuation of the practice presented an unnecessary risk to patients. In the absence of the SNBTS bringing the potential health risks of collecting blood from prisons to the attention of the SHHD, one can perhaps understand why SHHD officials did not consider the issue or bring it to the attention of ministers. By way of example, the Finnish Red Cross had considered the matter and had taken the decision, in 1975, to cease collection in penal institutions having regard to the results from the introduction of more sensitive Hepatitis B screening tests around that time. The SNBTS Transfusion Directors could have given similar advice to the SHHD as Dr Helske gave to his government agencies, although it must be borne in mind that Finland had a highly centralised service. It appears that it was not exposed to differences of opinion such as existed between Dr Wallace and Dr Brookes.

26.248 Although by March 1983 Professor Cash, the National Medical Director, appears to have been of the view that the practice of collecting blood in prisons should cease, he could not bring about the end of that practice in Scotland. Regional Directors did not report to, or accept review by, the National Director. If a Regional Director considered that the practice should continue in his region, he was free to follow that course. One of the effects of this limitation in the effective powers of the National Medical Director of the SNBTS was that, in the absence of consensus amongst the Regional Directors, collective action could not be taken.

26.249 Even if the Scottish Transfusion Directors had tried to reach a collective view before 1983 on the practice of continued collection in penal institutions, it is not obvious that agreement would have been reached given the differences of professional opinion among them. It is important to avoid colouring the evidence that has been gathered, with the benefit of hindsight. A speculative proposition about 'what should have been obvious' would be easily made and might be superficially attractive; there is, however, no basis on which it could be suggested that the differences of opinion among experts were other than genuinely held and honestly and reliably reported. Given the evidence that has been narrated, including the lack of a uniform practice among the transfusion regions in England and Wales or in other European countries, there is no point in the chronology at which it can be said that the SNBTS Directors should have delivered a consensus opinion to government that prison collections should be terminated before 1983 when they voluntarily began to withdraw from prison collections (with the exception of Dr McClelland who, prompted by his regional donor organiser, had stopped earlier).

Conclusions

Intravenous drug use

26.250 The International Society of Blood Transfusion (ISBT) Guide Criteria for the selection of blood donors of 1976 identified individuals suspected to be parenteral drug addicts among those who should be excluded from donating blood.

26.251 In 1977 the BTS produced the Memorandum on the Selection, Medical Examination and Care of Blood Donors. It was used as guidance by all Scottish RTCs in developing their local policies. It stated that 'Illicit drug taking if admitted or suspected should debar'. Similar wording was contained in the Standards for the Collection and Processing of Blood and Blood Components etc published by the DHSS in 1979.

26.252 Before the advent of AIDS in the early 1980s, therefore, it was known that drug taking by a potential donor and, in particular, intravenous drug taking, should exclude the potential donor from donating blood. The measures implemented within the SNBTS in order to exclude such individuals from donating blood included inspection, assessment and, to a limited extent, interview. However, up until the advent of AIDS in the early 1980s it seems likely that there was no uniform policy within the organisation in order to ensure that donors were routinely and directly questioned on their drug use.

26.253 In any voluntary donation system there would always have been (and there continue to be) limitations on the procedures that might reasonably be followed to exclude the risk of accepting blood from a prospective donor with a history of intravenous drug use. Full medical examination was, and remains, impractical. The health questionnaire forms used in current practice contain questions focused on risk associated with 'ever' having injected drugs and the forms must be signed by prospective donors in the presence of a member of staff. The requirement for signature was an important step forward. However, the effectiveness of the collection system to exclude or reduce risk related to parenteral drug use (in particular, in relation to risks arising from blood-borne viruses for which sensitive screening tests are not yet available) still depends on the reliability of the prospective donor and, at the end of the day, in some cases at least, on the donor's honesty. Notwithstanding the risk of upsetting some prospective donors, there is no alternative to emphasising in direct interview the prohibition on donation associated with a history of injecting drugs, so as to limit the scope for error or the provision of inaccurate information.

Collection of blood from prisons

26.254 The evidence obtained by the Inquiry indicates that blood was collected from penal institutions in Scotland from at least 1957 until the last prison session took place in each individual region.^[347] The last prison donor sessions took place respectively in the south east (Edinburgh) on 22 December 1981; north (Inverness) on 24 February 1983; north east (Aberdeen) on 28 July 1983; east (Dundee) on 2 August 1983; and west (Glasgow) on 25 March 1984.^[348]

26.255 The ISBT Criteria for the Selection of Blood Donors in 1976 proposed that prospective donors should be excluded if they are 'inmates of a correctional institution'. However, in this as in other matters, individual Transfusion Directors exercised a high degree of autonomy in donor selection and it is not possible to state that there was uniform practice.

26.256 Practice among European blood transfusion services in respect of collecting blood from prisoners clearly differed. In particular:

• Some countries never collected blood from prisoners (Denmark, the Netherlands^[349] and Eire).
• In the 1970s some countries introduced a permanent or temporary deferral of blood collected from prisoners (Switzerland, 1970^[350]; Belgium, mid-1970s; Finland 1975).
• Some countries ceased the collection of blood from prisons in the 1980s (England and Northern Ireland, 1983; Scotland, 1984; Luxembourg, 1985; France, 1985-89).^[351]
• Other countries did not introduce a permanent or temporary deferral of blood donation by prisoners until the 1990s (Portugal, 1990; Austria, 1995; Germany, 1996; Norway, 1997).^[352]

26.257 There was no evidence before the Inquiry that any additional steps were taken at prison donor sessions in Scotland to seek to screen out higher risk donors such as those who had ever injected drugs.

26.258 Dr McClelland's decision in 1981 to discontinue prison sessions was prompted by the views of the regional donor organiser. The decision was based more on the fact that prisons were felt to be an unsuitable environment in which to conduct donor sessions, than on concerns that prisoners' blood was thought to carry an increased risk of infectious diseases, including NANB Hepatitis. It was open to other Regional Transfusion Directors to have done the same.

26.259 It appears that Regional Transfusion Directors in Scotland collectively did not apply their minds to whether collection from penal institutions carried a greater risk of transmission of infectious disease and whether, therefore, the practice should continue until the matter was raised by the Medicines Inspectorate in 1982. However, the Medicines Inspectorate appear to have raised the matter at that juncture because Dr Brookes had informed them of her concerns about the practice of prison collection when they inspected Dundee in March 1982. The matter was first discussed by the Scottish Transfusion Directors, collectively, at their meeting on 29 March 1983.

26.260 It is unfortunate that consideration was not given by the Scottish Transfusion Directors, collectively, as to the appropriateness of continuing with prison collection prior to the matter being raised by the Medicines Inspectorate in 1982. There was evidence in the 1970s showing an increased prevalence of Hepatitis B in the prison population, knowledge that tests for Hepatitis B were not completely sensitive and emerging knowledge of an additional hepatitis disease, NANB Hepatitis, from about 1974 onwards which, like Hepatitis B, was also transmitted by blood.

26.261 Had the Transfusion Directors applied their minds to the practice, however, it cannot be said that they are likely to have decided to stop collecting in prisons or that it was unreasonable for the practice to have continued until the early 1980s. In particular:

• While there was evidence in the 1970s of an increased prevalence of Hepatitis B among the prison population in Scotland, it was reasonable to think that by the mid-1970s available tests for Hepatitis B had become sufficiently sensitive to detect most, if not all, carriers of that virus.
• While knowledge of NANB Hepatitis emerged and developed from around 1974 onwards, the disease was considered in the late 1970s and early 1980s to be clinically mild in most cases.
• It does not seem to have been suggested in the late 1970s and early 1980s that there may have been an increased prevalence of NANB Hepatitis in the prison population in Scotland (and had such a suggestion been made it could only have been a tentative one given the absence of any tests for NANB Hepatitis with which to establish the hypothesis).

26.262 Against that background, and in the absence of any instruction or direction from government in Scotland, it cannot be said that the Scottish Regional Transfusion Directors acted unreasonably in continuing to collect blood from prisons until the early 1980s.

26.263 In addition, given the variation in practice in transfusion regions in England and Wales and in other European countries, it cannot be said that the practice in Scotland in the 1970s and early 1980s to collect blood from penal institutions was out of step with generally accepted practice elsewhere.

26.264 With the benefit of hindsight, it seems likely that there was a higher prevalence of Hepatitis C in the prison population in Scotland in the 1970s and early 1980s than among the general donor population, probably as a result of a higher proportion of prisoners with a history of injecting drug use. It is not possible so long after the event and given, in particular, the lack of data on the incidence of NANB Hepatitis/Hepatitis C among prisoners in Scotland in the 1970s and early 1980s (and indeed the lack of data on the incidence of NANBH/Hepatitis C in the general population and general donor population at that time) to estimate the extent to which blood collected from penal institutions carried an increased risk of transmitting HCV. All that can be concluded, with the benefit of hindsight, is that blood collected from prisoners during that period is likely to have had an increased risk of transmitting HCV, albeit the chance of receiving blood collected from prisoners was, overall, relatively low given that only approximately 1% of all donations collected in Scotland between 1975 and 1984 was collected from penal institutions.

US Military Personnel

26.265 The amount of blood collected by the SNBTS from US military personnel based in Scotland was even smaller, ie approximately 0.2% of all donations collected in Scotland. In any event, there is no support in the evidence before the Inquiry for the suggestion that American service personnel presented a higher risk of transmitting HCV (or indeed HIV) than the general Scottish or UK donor population.

Appendix to Chapter 26

Table 26.1: Blood donation and prisoners, Synopsis of the answers by EBA members, September 2004

	Mandatory deferral	Reason for deferral	Mode of deferral	Time of introduction	The measure challenged?	Ethical issues
Austria	Yes	Epidemiological HBV, HCV	Permanently?	~1995	Never	Not voluntary
Belgium	Yes	Epidemiological HBV	One year	Mid 1970s	Never	None
Denmark	Yes	Epidemiological	One year	Never been used as blood donors	Never	None
England	Yes	Epidemiological HBV, IV drug abuse		1980s	Never	None
Finland	Yes	Epidemiological HBV		1975	Prisoners' organisation	None
France	Yes	Epidemiological HBV, HIV	Not permanently	1985/1989	Prison administration	Rehabilitation of prisoners
Germany	Yes	Epidemiological	Permanently	1996	Prison administration	None Rehabilitation?
Ireland	Yes	Epidemiological HBV, HCV	One year after release	Never		None
Luxembourg	Yes	Epidemiological HIV		1985	Never	None
Netherlands	No	Evaluation of individual risk behaviour		Early 1980s. No blood collection in prisons	Never	True volunteer status
Northern Ireland	Yes	"high risk"		1983	Prisoners' representatives	"True volunteers?"
Norway	Yes	Epidemiological	One year after a 72-hour arrest	1997	Never	None
Portugal	Yes	Epidemiological		1990	No	None
Scotland	Yes	Epidemiological		1983		None
Sweden	No		Risk evalua-tion of the individual. Deferral of 6 months after 72 hours in prison
Switzerland	Yes	Epidemiological HBV; drug abuse	Only persons in prison	1970	Never	None
Wales	not deferred		Those serving a custodial sentence cannot donate

Table 26.2: Donations collected in each Scottish RTC 1971-84

Year	Total number of donations in each region					Total Scottish donations	Total prison donations*	Prison donations (% Total)
	Edinburgh	Aberdeen	Inverness	Glasgow	Dundee
1971	n/a	n/a	8500	107,251	24,654	n/a	1126	n/a
1972	n/a	21,156	9000	107,462	25,258	n/a	902	n/a
1973	n/a	21,960	9500	107,249	26,207	n/a	875	n/a
1974	n/a	22,612	10,000	113,312	27,551	n/a	5125	n/a
1975	59,326	23,364	10,482	124,701	30,685	248,558	5915	2.38
1976	62,239	27,125	10,632	130,022	32,531	262,549	2633	1.00
1977	69,878	29,089	11,505	133,736	33,564	277,772	2710	0.98
1978	75,302	29,841	12,697	133,203	32,263	283,306	3436	1.21
1979	77,318	30,565	13,701	135,831	32,663	290,078	4371	1.51
1980	75,639	32,252	14,033	135,008	32,392	289,324	3064	1.06
1981	74,537	33,434	14,388	139,546	31,596	293,501	3360	1.14
1982	73,985	34,803	15,256	142,056	31,751	297,851	2356	0.79
1983	74,146	34,373	16,226	145,944	31,544	302,233	3120	1.03
1984	81,232	33,863	14,539	148,909	30,074	308,617	342	0.11
* Excluding prison donations from Inverness RTC for which records were lost in a flood.

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27. Surrogate Testing of Donated Blood for non-A, non-B Hepatitis >