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Origins of blood transfusion service – Protein Fractionation Centre, Edinburgh – scope of PFC’s operations – projected levels of demand for blood products – commitment to self sufficiency – Scottish administrative structures – early stages in blood product production – growing demand for blood products, domestically and internationally – the voluntary principle and self sufficiency – blood collection in Scotland – use of blood donations – collection from prisoners – changes in the processing and use of donations – developments in fractionation practice – production volume targets in the 1970s – production capacity and production at PFC compared - continuing discussion of demand at UK and Scottish levels – assessment of the overall position in the 1970s.

Early history of blood organisation

5.1 The origins of a blood transfusion service in Scotland can be traced back to 1930 when a service was established at the Edinburgh Royal Infirmary. At first the service operated on a small scale and was organised by a volunteer, but as demand for the service increased so did the need for a larger organisation. In 1936 the Lord Provost of Edinburgh formed a committee to take over responsibility for the service.[1] In 1939 the Department of Health for Scotland set up a Blood Transfusion Sub-Committee which recommended that stores of blood should be made available in centres across the country.[2]

5.2 Increasing knowledge of blood transfusion techniques highlighted the need for a national organisation. On 5 March 1940 the Department of Health for Scotland established the Scottish National Blood Transfusion Association (SNBTA). The SNBTA was originally constituted as a charitable body and was responsible for five Regional Transfusion Centres (RTCs). The five RTCs were in Aberdeen, Dundee, Edinburgh, Glasgow and Inverness. The Association was not fully funded: it was expected to operate on the basis of small government grants and significant voluntary contributions.[3]

5.3 One of the first acts of the new body was to bring consistency to the practice of recruiting donors. Previously some areas had made a small payment but the Association favoured the use of voluntary donations and decided to bring an end to the practice of making payments to donors. Although the Association favoured voluntary donations from members of the general public it was common practice for blood to be collected from prisons and borstals.[4]

5.4 In the early 1940s the value of plasma became apparent and demand for it increased. Large scale production of blood products in the United Kingdom, and in Scotland in particular, had its origin in a decision in 1941 by the United Kingdom Government to finance two facilities for the preparation of freeze-dried human plasma.[5] In Scotland,
a sub-committee of the SNBTA recommended that plasma filtration units should be established in Edinburgh and Glasgow. In accordance with government policy, the Edinburgh unit was to be responsible for the production of dried plasma which could be transported abroad and reconstituted.

5.5 When the National Health Service was established in 1947[6] the Secretary of State for Scotland took over control of the RTCs, equipment, vehicles and paid staff of the SNBTA. However, the SNBTA remained as a charitable body responsible for administering the service under similar financial arrangements as before.

Creation and structure of PFC

5.6 The Edinburgh centre was created in 1950 and situated within the Royal Infirmary. It was named the Blood Products Unit (BPU). The facilities were not sufficient for the expanding operation and by February 1965 planning for a new centre was being discussed at meetings between the DHSS, the Scottish Home and Health Department (SHHD) and the Blood Transfusion Services of England and Wales and of Scotland.[7] Mr John Watt was appointed first director of the proposed facility in 1966. In May 1968 a meeting was held between the Scottish Home and Health Department and the Blood Transfusion Services to continue discussion of the proposed new centre[8] which was eventually given approval in November 1969.[9] In April 1970 the BPU was renamed the Scottish Protein Fractionation Centre (PFC) and in 1974 it relocated to the purpose built facility at Liberton. By that date, Edinburgh was manufacturing a wide range of products: fibrinogen, human albumin, anti-vaccinia immunoglobulin, anti-D immunoglobulin, prothrombin complex (Factors II, VII, IX and X) concentrate, anti-tetanus and anti-rubella immunoglobulin, and, in 1974, a new-generation intermediate-purity Factor VIII concentrate (‘NY’ Factor VIII). Dr Peter Foster, who specialised in biochemical engineering, joined the service in 1973. The plant was in routine operation from 1976. Although the centre was originally planned with a view to manufacturing products for both Scotland and England this was never achieved.

5.7 From April 1974 onwards the PFC was divided into specific functional departments which were:

• Production

• Quality

• Engineering Maintenance

• Project Engineering

• Research and Development

• Administration/Business Services

5.8 Each head of department reported to the Scientific Director of the PFC who was responsible for the management of all the activities of PFC and was accountable to the Management Committee of the Common Services Agency (the ‘CSA’) until 1991. Thereafter the post was accountable to the Scottish National Blood Transfusion Service (SNBTS) General Manager/National Director.

5.9 The main functions of the PFC were:

• The manufacture of medicinal products from human plasma supplied by the SNBTS (and in the course of time Northern Ireland Blood Transfusion Service).

• The supply of resultant plasma products to RTCs for distribution to Health Boards in Scotland (and later Northern Ireland).

• The undertaking of research and development in relation to plasma products.

• The provision of information and advice on matters of plasma fractionation by the Director of the PFC and other senior personnel to SHHD, DOH and to other national and international bodies as required.

PFC’s operations

5.10 From the beginning there appears to have been uncertainty about the scope of the Scottish facility’s operations and the production volume targets for which it was to be designed. It was initially estimated that the new facilities required in Scotland to manufacture plasma products should be capable of processing up to 1000 litres of plasma per week, including plasma from England.[10] This reflected a decision that would have required continuing cooperation between the service in England and Wales on the one hand and Scotland on the other while under separate administrative agencies. On a practical level, it implied that a manufacturing capacity of 1000 litres of plasma per week would suffice to service demand in Scotland and in a northern part of England that would require definition.

5.11 The projected capacity of the Scottish facility was amended in discussion. In May 1968, at a meeting at the Royal Infirmary, Edinburgh between the SHHD and the Blood Transfusion Services of England and Wales and of Scotland[11] it was anticipated that the PFC, Liberton, would be commissioned in June 1972 with an initial capacity of 1500 litres of plasma per week but capable of being increased to 3000 litres per week. It was agreed that the Edinburgh centre should be prepared to cope with the requirements of a larger part of England than originally intended. It was agreed that requirements for labile coagulation products needed to be revised.

5.12 At a meeting in November 1968, at BPL Elstree,[12] between the SHHD and the Blood Transfusion Services,[13] it was noted that approval in principle had been given for expenditure of £1million on the new Liberton fractionation centre. A building designed to operate at 1500 litres plasma per week but equipped initially to operate at 1000 litres per week was envisaged at an estimated cost of £1.2 million. It was also noted that commissioning of the new Elstree extension was expected to be completed by mid-1971 at a cost of £600,000. The Edinburgh project was approved for procurement in November 1969.[14] A firm starting date for building the new Edinburgh fractionation centre had not been decided but it was thought that completion of commissioning was likely to be early in 1973. It was hoped to start building the extension at Elstree in September 1969 with commissioning expected early in 1972.

5.13 At this stage, it was noted that UK policy matters needed to be coordinated and it was proposed that the SHHD should contact the DHSS with proposals to form a coordinating committee. It was agreed that Elstree should process two thirds of the plasma collected from England and Wales with the remainder being processed in Scotland. In June 1969, a meeting took place at BPL Elstree between the SHHD and the Blood Transfusion Services of England and Wales and of Scotland.[15] Total production targets were not resolved. It was decided that the quantity of plasma required for the production of Factor VIII and Factor IX concentrates would be discussed with Dr Rosemary Biggs of the Oxford Haemophilia Centre. By this stage, Dr Biggs was a leading authority on levels of demand for therapeutic products for haemophilia patients, actual and projected. But, on the basis of the information available, it would be difficult to form the view that the planning of production was firmly established, on a United Kingdom or on a Scottish basis.

5.14 There was considerable uncertainty about levels of demand in the United Kingdom as a whole. At 5 April 1971, it was recognised that the total ideal requirement of material for treating patients with coagulation defects was not known.[16] The treatment of 1032 haemophilia and Christmas disease patients at the 30 centres from whom records were received was derived from 84,906 donors. But there was a waiting list of patients requiring non-urgent surgery. And the introduction of home treatment would probably increase the amount of material used. In the event, data returned for 1970 and 1971 saw the volumes used increase, in terms of donations to 105,531, and then to 132,743 units.[17] The 1969 data would not have provided a reliable basis for forecasting growth at such rates locally, and could not have provided a rational basis for projecting UK demand based on donor units. Later analysis of data further undermined the reliability of the 1969 figures as a basis for projecting demand. Further research was required.

5.15 In the undated report prepared for the Medical Research Council’s Transfusion Research Committee, and made available for a meeting of haemophilia centre directors on 31 January 1974, Dr Biggs and her colleagues set out a comprehensive review of the position based on studies of the period 1969 to 1972. The report included an attempt to estimate the total amount of therapeutic materials containing Factor VIII activity that was likely to be needed in the United Kingdom[18] together with the amount of fresh whole blood required for processing to meet that target.

5.16 Making allowance for haemophilia patients attending general hospitals, and extrapolating from accurate data for the Oxford Haemophilia Centre, the report estimated that the number of haemophilia patients treated in 1971 in the United Kingdom as a whole was between 2434 and 3000. Using data for donations used for cryoprecipitate and freeze-dried concentrate production and taking account of yield, the report concluded that for all types of bleeding, spontaneous, during surgery and for dentistry, the total demand required from 547,540 to 750,000 blood donations per annum. Home treatment would require 250,000 donations, as an alternative, but not cumulative, form of therapy. Prophylaxis would add further demand, but that approach to therapy was not recommended. At the time, 1.7million blood donations were collected annually by the Blood Transfusion Services for all uses, including transfusion in surgery and medical procedures.

5.17 Subsequently, Dr Biggs published information relating to the period 1969–74,[19] and the haemophilia centre directors supplemented that for 1975.[20] In her report of 1974, Dr Biggs stated:

An assessment of the total amount likely to be required for all types of treatment puts the total in excess of 500,000 blood donations annually or about 40 million factor VIII units.[21] Of this material at least half (and preferably all) should be supplied in the form of freeze-dried preparation in order that home therapy can be instituted on a reasonable scale.

5.18 The estimate was compatible with the lower level in the Medical Research Council report. The comparison with the 1969 assessment is stark. Later papers showed dramatic growth in demand, reported generally in terms of international units, though falling short of the estimate of 40 million units within the period in question. By 1974, total demand had increased to 20,548,060 units of Factor VIII and 4,866,380 units of Factor IX, amounts still far in excess of the 1969 estimate. For 1975, the amounts increased to 24,886,218 units of Factor VIII, and 4,914,643 units of Factor IX.

5.19 At the beginning of the reference period, therefore, there was considerable doubt about the levels of demand that ought properly to be anticipated, and this necessarily affected the efficiency of planning of the production facilities required. Since the Liberton facility had been conceived as one element in the total UK production capacity, its planning was directly affected.

5.20 However, there was a political commitment to self-sufficiency. In December 1974 David Owen, the UK Minister of Health, announced government funding of £500,000 to help with the move towards the UK becoming self-sufficient in blood products following WHO recommendations.[22] The funding was to be used to provide BPL in London with additional equipment to process the increased quantities of plasma necessary to meet the rapidly increasing demands for clotting factors for treating haemophiliacs. In parallel, in Scotland, by the end of 1974 construction work on PFC Liberton had been completed.

The Common Services Agency and the Scottish Home and Health Department

5.21 As at 1974, the SNBTA comprised the five RTCs and the PFC. The five RTCs were:

• East of Scotland Blood Transfusion Service located at Ninewells Hospital Dundee at the beginning of the reference period;[23]

• Edinburgh & South East Blood Transfusion Service located at the Edinburgh Royal Infirmary;

• Glasgow & West of Scotland Blood Transfusion Service located at Law Hospital, Carluke;

• North East of Scotland Blood Transfusion Service located at Forresterhill Hospital, Aberdeen; and

• North of Scotland Blood Transfusion Service located at Raigmore Hospital, Inverness.

5.22 Each of the RTCs was headed by a medically qualified Regional Transfusion Director who was responsible for the management of the activities of their centre, namely:

• Recruitment and selection of blood donors.

• Collection of whole blood, plasma and platelet donations.

• Testing of donations.

• Processing of blood donations to prepare blood components for transfusion and plasma for fractionation.

• Distribution of SNBTS blood components to hospital blood banks in Scotland.

• Distribution of SNBTS plasma products.

• The operation of hospital blood banks at Edinburgh Royal Infirmary, Gartnavel Hospital (Glasgow), Aberdeen Royal Infirmary, Ninewells Hospital (Dundee) and Raigmore Hospital (Inverness).

• Undertaking research and development.

5.23 Shortly before the reference period, there were major structural changes in management. The National Health Service (Scotland) Act 1972 established the Common Services Agency for the Scottish Health Service (CSA) to manage the service. The new division of the CSA was named the Scottish National Blood Transfusion Service (SNBTS) and the responsibility for the provision of human blood for transfusion and the production of blood products was transferred to this new division.[24] The main aim of the SNBTS was ‘the provision of safe blood and blood products to meet patient needs in the prevention, diagnosis and treatment of disease and injury’.[25] The SNBTA remained as a charitable body and continues to this day to represent the interests of blood donors in Scotland. It supports the activities of the SNBTS but is independent of it and operates on a much smaller budget.

5.24 The SNBTS and the CSA were overseen, and funded by the SHHD. All blood and blood products prepared by the SNBTS were funded through this route and supplied free of any direct charge to the health boards and hospitals. The SHHD were involved in decisions about resourcing of the SNBTS and were represented by senior officers, including the Deputy Chief Medical Officer, at meetings of the CSA Management Committee and at meetings of the Blood Transfusion Sub-Committee which met quarterly to administer the SNBTS.

5.25 In addition to overseeing the CSA the SHHD organised and chaired annual meetings with Scottish haemophilia centre directors and SNBTS directors, from 1973, to consider the provision of blood products for the treatment of people with haemophilia. The SHHD also maintained close links with the Department of Health and Social Security and its predecessors in London.

5.26 The role of the CSA in administering blood transfusion was the subject of much debate and criticism by the Scottish transfusion directors[26] and in 1976 it was stated:

It has become apparent that if the purpose of the reorganisation was to improve efficiency, it has been an abysmal failure; on the other hand if the purpose was to decrease unemployment by creating large numbers of new, mainly unproductive, administrative posts, it can be looked upon as an outstanding success.[27]

5.27 However, despite these criticisms, the CSA remained in place as administrator of the SNBTS and continues to do so today as NHS, National Services Scotland.

5.28 Until 1990 the regional transfusion directors were considered accountable to the CSA Blood Transfusion Sub-Committee of the CSA Management Committee, as was the SNBTS National Medical Director/National Medical & Scientific Director. In 1990 the post of SNBTS General Manager was created and the directors were made accountable to the General Manager on managerial aspects and were professionally accountable to the National Medical and Scientific Director. There was one central body, the Management Board, through which all policy and strategic decisions passed.[28] The Management Board comprised the General Manager, the National Medical & Scientific Director, the Regional Directors, the Director of the PFC, the Director of the National Science Laboratory, the National Finance Manager, the National Donor Services Manager and the National Administrator.[29] The CSA Management Committee met for the first time on 19 June 1990 to finalise its remit in the new structure.[30]

5.29 The PFC was headed by a Scientific Director who was responsible for the management of all of the activities of PFC and was accountable to the Management Committee of the CSA until 1991. Thereafter the post was accountable to the SNBTS General Manager/National Director.

5.30 RTC medical staff did not have direct clinical responsibility for the care of patients and were not clinically responsible for the transfusion of patients. Those responsibilities remained with the individual consultants who had under their care patients requiring transfusions of blood or blood products.

5.31 In 1998, following public consultation,[31] a major re-organisation of the SNBTS took place. Part of the reasoning behind the changes was ‘to allow clinicians to concentrate on closer working with local hospitals in delivering more effective clinical care via the use of blood and blood products’.[32]

5.32 As a result of the re-organisation responsibilities for blood donor management, blood collection, processing and distribution were transferred from the five RTCs to National Directorates which reported to the National Director (formerly the SNBTS General Manager). These Directorates were:

• Supply Chain (including Donor Services, Manufacturing and Logistics).

• Protein Fractionation.

• Quality.

• Research.

• Finance and Procurement (which was divided into Human Resources, Information Technology and Estates).

5.33 Hospital blood banking, the provision of advice and information on transfusion medicine to hospitals and some diagnostic services remained based in the regional centres. The Regional Transfusion Directors were re-designated Clinical Directors and formed a new Clinical Directorate under the National Medical and Scientific Director.

The scientific context: blood products

5.34 It is difficult to capture the atmosphere of medical and scientific research and development at the beginning of the reference period. Several factors interacted. Politically, on domestic and international fronts, there was a considerable upsurge in interest in the management of blood resources. Medical and scientific knowledge was changing rapidly. There was technological change, and there was increased interest in exploiting scientific knowledge and technical capacity in the service of national policies. There was a growing market in blood products, leading to increased commercial production, and tension among the pharmaceutical companies involved, the public production facilities, and regulators. Since most of the issues that emerged were real only because of the processes that scientific development had made practicable, it is important to have an understanding of the position reached in the manufacture of blood products at or near the beginning of the reference period not only in Scotland, but more generally.

5.35 The history of the processing of blood for therapeutic use, and the characteristics of blood that are exploited in the production process have been described in the introduction. By the middle years of the twentieth century, many of the basic procedures were well established in Scotland, as elsewhere. Red cell preparations, including concentrates, were isolated. Platelet and leukocyte concentrates were derived from processing the buffy coat isolated in the primary separation procedure. In the earlier years of the reference period, these operations progressively superseded the use of whole blood for therapeutic purposes. Later, the further processing of plasma became the principal downstream procedure of interest for present purposes. Plasma might be frozen fresh and drawn from store in that form for therapeutic purposes. Or it might be processed to produce:

• Factor VIII cryoprecipitate.

• Purified clotting factors:

– Fibrinogen

– Antithrombin III

– Factor VII

– Factor VIII

– Factor IX

– Factor XI

– Factor XIII

– Thrombin

– Fibronectin

• Albumin solutions.

• Immunoglobulins which may be non-specific or have a wide range of specific applications.

5.36 It is unnecessary to trace the early history of the technological development of the procedures for producing these components in any detail for the purposes of this chapter. As noted in the Introduction, the work of Dr Cohn was of central importance in the developing technology. By the mid-1960s, there were effective procedures available for the production of these products on a large scale.[33] From about 1961, Cohn fraction 1, relatively rich in Factor VIII (antihaemophiliac globulin) activity appears to have been produced at BPU Edinburgh (renamed PFC in 1970), and, until 1970, it was the predominant preparation containing Factor VIII used to treat haemophiliacs in South-East Scotland. It was referred to as ‘Anti-haemophilic fraction’ (AHF) by Cash and Spencely.[34] A Cohn fraction 1 Factor VIII preparation was used in Oxford during the 1960s. It was referred to as ‘NHS VIII Concentrate’ by Dr Biggs.[35]

5.37 In addition to production technology, the selection of material for processing, and the donor pool size used were material issues for the blood transfusion services. For many years, in the United Kingdom and the United States of America, plasma from a large number of donors was pooled randomly for therapeutic use, with the objective of lowering the likelihood of transmitting hepatitis, since it was thought that some donors would possess neutralising antibodies against possible infective agents. However, pooling on that basis was found still to contain considerable amounts of infective material, carrying a high risk of transmission of hepatitis and, in about 1967, the use of pooled random donor plasma for therapeutic application was abandoned.[36]

5.38 In the reference period, plasma was pooled for processing into the products already mentioned. It was thought that the procedures adopted reduced the risk of virus transmission. As already noted, cryoprecipitation of Factor VIII from pooled plasma was a commercial scale operation using multiple units of blood.[37]

Growing demand: the wider context

5.39 Improving technology, and widening markets for blood products led to increased demand for blood supplies, and there were political repercussions. In 1970 Richard Titmuss, a United Kingdom social scientist, published The Gift Relationship. An American edition followed in 1971, where the book had an immediate impact. Titmuss compared the blood donor systems of England and Wales with those in use in the United States of America. The two systems had developed along quite different lines. As seen by an American commentator, Douglas Starr,[38] the American system had developed as a mixed-economy model, incorporating the community-resource model of the American Red Cross and the commodity model of the for-profit blood bankers and plasma industry, which relied heavily on purchased blood. By contrast, the British system followed the social welfare model, with blood treated as a free community resource, collected and distributed by the state. Starr commented: ‘Titmuss portrayed the differences between the two systems almost starkly as good versus evil.’

5.40 Public interest in the American edition was intense. The book was rated one of the seven best books of 1971 by the New York Times.[39] It had immediate impact on the public at a time when the American system was coming under intense scrutiny. It also had political impact. Titmuss’s American correspondent, Professor J Garrott Allen, a surgeon at Stanford University Medical School, had published research into the differential incidence of hepatitis in recipients of blood collected for payment and recipients of blood received from volunteers.[40] Recipients of ‘professional’ blood were ten times more likely to contract hepatitis on his findings.[41] He entered into correspondence with Elliot Richardson, head of the US Department of Health, Education, and Welfare, and, as such, head of the Division of Biologics Standards. He sent Richardson a copy of The Gift Relationship in December 1971.[42] Starr writes:

Several things now happened in quick succession. In early 1972, Richardson, having read the Titmuss book during his Christmas vacation, directed his staff to form a task force to look at new ways of managing the American blood supply. A couple of months later, President Nixon, declaring blood ‘a unique national resource’, ordered the Department of Health, Education, and Welfare to make an intensive study of better ways to manage it. Several congressmen introduced bills to reform the nation’s blood-services complex. In May, Richardson, testifying in Congress, made a seat-of-the-pants declaration that completely upended the regulation of blood. He announced that he would remove the job of regulating blood banks from the toothless Division of Biologics Standards and give it to the Food and Drugs Administration. The FDA had much broader powers than the DBS; now, instead of regulating and inspecting the few hundred facilities engaged in interstate commerce, the government would oversee every blood and plasma centre in the land – all seven thousand of them.

5.41 So far as the United Kingdom was concerned, observations on the book by Cumming and Cash in 1976[43] fell short of resounding acclamation. Titmuss’s concept of a ‘gift relationship’, was said to be oversimplified and limited in perspective, but they supported the view that blood donation in the United Kingdom was a relatively unique phenomenon and one which was intensely personal. Adverse comment on the book’s treatment of the United Kingdom transfusion services would not have been expected, given its general tone.

5.42 However, the book attracted wide international attention. In Canada, there was a radical review of the blood system in operation across the country. Dr Roger Perrault, who became the national director of the blood transfusion service in 1974, set out to reform the system, recruiting additional medical staff, and promoting developments aimed at meeting domestic demand for blood components and therapeutic blood products. In 1975, he retained Mr John Watt of PFC, Liberton, to report on how best the Canadian Red Cross could supply the full range of therapeutic blood products. Mr Watt’s recommendations reflected experience and practice in Scotland at that time.

5.43 By this stage, the World Health Organisation (WHO) had been alerted to concerns that commercial fractionators were buying plasma from persons in developing countries irrespective of the state of their health. The practice posed a risk both to those paid for their plasma and to the recipients of blood products made from it. Preliminary inquiries by the World Health Organisation indicated that there was ‘an extensive trade in human blood and its derivatives in many countries’. In May 1975 the organisation passed a resolution that, among other things, urged its member states ‘to promote the development of national blood services based on voluntary non-remunerated donation’. The hope was that, as more countries became self-sufficient by collecting enough plasma from volunteers to meet their domestic demand for blood products, the incentive for commercial firms to pay persons in developing countries for their plasma would decrease.

5.44 A number of strands of thought emerged that were to have a significant impact on international and domestic policy. The WHO had moved towards encouraging policies of self-sufficiency and non-remunerated voluntary donation. Regulation in America was amended radically. Professor Garrott Allen’s findings that blood from paid donors carried a relatively high risk of transmitting hepatitis had wide implications. But the commercial trade continued to increase, in response to demands that could not be met locally. Many countries, including England, Wales and Scotland, were self-sufficient in whole blood and most of its components and products, for example albumin and fresh frozen plasma. But the rocketing demand for coagulation Factor VIII and IX concentrates, derived from a minimum of hundreds of units of blood, could only be satisfied by resort to commercial coagulation products largely sourced from the United States of America.

5.45 The change from the therapeutic use of fresh frozen plasma to cryoprecipitate (which was prepared generally from up to 10 donations) and then to the use of factor concentrates (using pools of up to 10,000 units of plasma) stimulated commercial production and the growth of commercial fractionation by pharmaceutical companies, primarily in the USA. The development of Factor VIII and IX concentrates was a life changing event. Haemophilia patients were given an opportunity of relief from suffering that inevitably led to increased demand for blood products, and created a commercial opportunity that a small number of pharmaceutical companies seized.

5.46 The demand for plasma generated by expanding production overwhelmed domestic capacity to supply. Commercial operators increasingly turned to other sources. Plasma was obtained and imported from foreign sources, often third world countries, and from prison populations, in order to accumulate the large pools required to extract the factor components. This prompted growing concern about the trade in blood and its components and an emerging international consensus that reached a climax in the 1970s.

5.47 The mid-1970s, therefore, was a period when international attitudes to the trade in blood and products were changing, and there was a distinct policy steer towards national self-sufficiency in blood and blood products. There was a growing emphasis on the importance of protecting vulnerable donors in disadvantaged circumstances from exposure to the risks associated with the sale of their blood and plasma. And there was emphasis on voluntary donation as the ideal.

5.48 As expressed in the United Kingdom, the reaction against exploitative collection of plasma from third world countries was associated with an expression of confidence in the ‘purity’ of domestic volunteer supplies of blood for transfusion, and the advantage, in Scotland in particular, of early self-sufficiency. As concern about transmitted disease increased, it was frequently associated with imported products, explicitly or implicitly distinguishing the domestic production of concentrates as presenting lower risk to users. This promoted the advantages of self-sufficiency, and prompted technological developments aimed at the more efficient and effective production of concentrates. It also formed a material factor in the background to the development of the United Kingdom production facilities, though the steps taken to implement policy fell far short of what was required.

Blood collection

5.49 In Scotland, in the mid-1970s, the collection and initial processing of blood was organised on a regional basis. However, most donations were collected at mobile sessions held away from the Regional Transfusion Centres. Voluntary donation was at the heart of policy and practice. It was universally accepted and admired. Perhaps reflecting the variability of response inherent in the voluntary principle, there was a considerable turnover in the donor population. For 1975–76, the pattern was as follows:


Donors bled

New donors






























5.50 The 1975–76 figures show material variation among the regions in changes in the donor population. One would anticipate that individually, and in cumulo, the response rates would vary. Viewed broadly, however, these data illustrate the vulnerability of the donor supply to personal factors which were likely to be as varied as the population itself, and demonstrate that security of the supply would require recognition of the importance of relationships with donors. It was recognised throughout the reference period that the goodwill of the donor population was essential to the success of the system, and that the utmost care was required to ensure that no individual or collective causes for dissatisfaction should arise.[44] Sensitivity to the risk of adverse donor reaction has been apparent at a number of stages in the developing history.

5.51 In the early years of the reference period, data were returned to SNBTS of the percentages or numbers of ‘donors rejected’ by the Regional Transfusion Centres. In the early 1980s the language changed. ‘Deferrals’ were recorded and returned rather than rejections, but the process described had the same result: the blood donated was not used in transfusions or further processing in the production of therapeutic products. In 1974–75, the percentage that was not used was 8.37 for the whole of Scotland. Rates of eight per cent plus or minus 0.3% were returned consistently until 1980–81. For 1981–82 the rate deferred was 9.3%. The following year the rate was 9.5%. In 1984–85 it was nine per cent. In the early years of the reference period the reasons for rejection or deferral were not recorded in the standard returns. Generally, it was acknowledged[45] that in some cases the reason might render the donor permanently unsuitable, for example where there was a chronic disease state, while in other cases the reason might only render the donor unsuitable short-term, for example where there was a short-term upper respiratory tract infection. A detailed study of the reasons for rejection as a continuing exercise to be carried out at national level was rejected as unjustified in view of the resources required. As a result, it is impossible to attribute the rate of rejection or deferral to the success of the transfusion service’s HBsAg or other normal screening procedures or any other specific factor. On the other hand, it can be inferred that, throughout the reference period, certain procedures were employed to exclude from the downstream supply of blood and blood products, source material that was known to present a risk, according to the knowledge and standards of the time. The scope of those procedures and their effectiveness in the event are discussed elsewhere.

5.52 At the beginning of the reference period, transfusion in surgery and other applications in the United Kingdom, including Scotland, typically used whole blood,[46] and most blood donations were transfused in that form. The practice depended on the immediate availability of fresh blood, and in that respect, the United Kingdom was, and had to be, self-sufficient. In the course of the reference period, the pattern of usage of donations changed. The general pattern of donations and their main applications in Scotland is reflected in Figure 1. The transfusion of whole blood continued to fall in absolute terms and as a percentage of the available usable blood throughout the reference period. The trend became more pronounced with time. By 1989–90 the percentage of total whole blood donations transfused as whole blood was less than 4%. The proportion of usable blood separated into its principal components is measured by the production of red cell concentrates at RTCs. That proportion increased over the period until 1989–90. PFC’s records of deliveries of fresh frozen plasma from RTCs showed a significant increase in 1989–91 over the period 1986–88. In the earlier two years the quantities delivered were 45,000 and 52,000 kilograms respectively; in the later two years the quantities were 64,000 and 76,000 kilograms, reflecting a change from local separation out of the cellular components of donations.

Figure 1


5.53 Over the period covered by the graph, apheresis became a little more common, giving some further emphasis to the trend away from whole blood transfusion, but it did not become significant in volume. In the case of plasma, in 1974–75 recorded donations by plasmapheresis were 3312. By 1977–78, the number had risen to 4632. In 1980–81, there were 7863 plasmapheresis donations. Over that period, there was growth, but it was hardly enough to make a material impact on the overall pattern of blood donation. The data recorded thereafter were expressed in kilograms for a time, and prevent direct comparison. But by 1989–90, apheresis donors generally numbered about five per cent only of the total donor population. Whole blood donation remained the norm in Scotland, possibly reflecting the peripatetic character of the blood collection system.

Collection of blood in prisons

5.54 The screening of donors for Hepatitis B was introduced in the United Kingdom in October 1970. From about that time there was evidence of a greater prevalence of Hepatitis B in prison populations in the United Kingdom than in the general population (as had been discovered in the United States of America). The extent to which blood was collected from prisons appeared to vary between the different blood transfusion regions across the United Kingdom, and across Scotland in particular.

5.55 On 26 September 1973 the Directors of the National Blood Transfusion Service (NBTS) for England and Wales met.[47] There was discussion of the prevalence of Australian antigen (later identified as HBsAg) in blood donors. It was noted that the prevalence of the virus in prisoners was higher than in the general public. The meeting considered whether the NBTS should stop collecting blood in prisons. Seven directors (Sheffield, Cambridge, Edgware, Brentwood, Tooting, Cardiff and Birmingham) thought prisoners should no longer be bled because the incidence of antigenaemia not detectable by IEOP[48] was probably higher in the prison population than among the general public. Seven (Newcastle, Leeds, Oxford, Bristol, Manchester, Liverpool and Wessex) were of the view that screening for Hepatitis B antigen gave adequate protection and that blood collection in prisons should be continued until the statistical significance of the figures had been examined. It was agreed that if it were decided to discontinue bleeding prisoners, the DHSS should inform the Home Office (which appears to have supported the practice) before any local action was taken. In 1975, following advice from an expert advisory group, the Chief Medical Officer for England and Wales advised that it was not necessary to discontinue the collection of blood from prisons and similar institutions.

5.56 On 4 October 1973 the SNBTS directors met.[49] Under the heading, ’Matters arising from the meeting of English RTDs’ (item 42) it was noted: ‘Prisoner Donors – Dr Maycock had produced data on the incidence of Au-positive [ie Australian antigen/Hepatitis B] blood amongst prisoner donors. The evidence was being re-examined and English directors were considering withdrawal of prison sessions’.

5.57 The Annual Report of Edinburgh and SE Scotland BTS for 1973–74 included an address given by Professor Anthony Ritchie, Chairman of the Central Consultative Committee of the SNBTS.[50] 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. However, it is not clear that the practice had ceased. A document dated July 1974 on behalf of the NBTS for England and Wales set out the frequency of Hepatitis B reported by RTCs in ‘new general public and factory donors’, in donors from the Armed Forces, and in donors from prisons, borstals and similar institutions.[51] The incidence of Hepatitis B antigen in donations from new general public and factory donors in 1973 was 1:1107 (0.09%). The incidence of Hepatitis B antigen in donations from prisons, borstals and similar institutions was approximately five times greater ie 1:214 (0.47%).

5.58 In America the practice persisted. On 6 January 1975 J Garrott Allen, Stanford University School of Medicine, California wrote to Dr William Maycock, Blood Products Laboratory.[52] He advised that Non-A Non-B Hepatitis was more frequently encountered ‘in the lower socio-economic groups and prison donors’.

5.59 There is evidence that the practice also persisted, and was sanctioned, in the United Kingdom, relying on the effectiveness of screening techniques to identify infected donations. On 1 May 1975 H Yellowlees, Chief Medical Officer for England and Wales, wrote to all regional medical officers on the subject of blood donation and hepatitis.[53] The DHSS had recently received advice from a group of experts on the use of blood donations from certain categories of donors.[54] As regards collection from prisons, the letter 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 so 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 [ie reversed passive haemagglutination and radio-immunoassay]. The Memorandum on the Selection, Medical Examination and Care of Blood Donors will be revised to take account of the advice we have received.

5.60 Recognition that the prison population (and intravenous drug abusers) had relatively high rates of infection continued to be recorded. On 27 February 1980 the DHSS produced a note in respect of the proposed setting up of the Advisory Group on Viral Hepatitis to advise the Department on various problems relating to viral hepatitis.[55] The note identified groups with much higher carrier rates of infection, including drug addicts and the prison population.[56]

5.61 In Scotland, the Medicines Inspectorate took an interest in the topic in 1982 during visits to transfusion centres and other facilities. Their report on their visit to Dundee BTS,[57] dated 25 March 1982, noted that it was most unlikely that the inspectors could endorse the continued collection of blood from prisons and borstals because (a) prison medical officers were often not involved in assessing the suitability of donors, (b) there was an increased risk of infection associated with prison populations and an increased risk of transmitting disease through such donations, and (c) unreliable answers to the pre-donation questionnaire could occur in such donors, whose motivation was questionable. The inspectors’ report of visits to Edinburgh and SE Scotland BTS in March and May 1982 also questioned whether collecting blood from donors in prisons and borstals was appropriate or necessary.[58] On 12 January 1983, in response to the Medicines Inspectors’ Report, SE Scotland BTS wrote: ‘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.’[59]

5.62 The issue was discussed during 1982.[60] More particularly, it arose at a meeting of SNBTS directors on 29 March 1983.[61] Dr Cash reported the Medicines Inspectorate’s views. He invited directors to comment on the practices in each region and to give their views on the Inspectorate’s criticism. The minutes state that it was reported by all directors present[62] that sessions were held in penal institutions in all regions, although Dr Brookes (Dundee) and Dr Urbaniak (Aberdeen) 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 (set up by the NBTS and the SNBTS, and chaired by Dr Entwistle) to consider this issue. In the meantime, Dr Cash agreed to inform the Medicines Inspectorate of these discussions and conclusions.

5.63 On 12 April 1983 Dr Cash wrote to Mr Haythornwaite of the DHSS Medicines Division.[63] He reported the discussions and lack of consensus. Dr Cash stated that the directors recognised that the problem would require further discussions and said that Dr Brookes would raise the matter at the next meeting of the UK Working Party which was currently reconsidering the whole question of donor selection and care.

5.64 On 27 July 1983 Mr J B Brown of the DHSS sent a note to Mr Parker on the use of blood from prisons.[64] The note stated that at a recent meeting of the Medicines Division’s Inspection Action Group concern was expressed about the collection of blood from prisons and borstal institutions. BTCs in Scotland were making use of these sources (particularly prisons) and some, at least, of the English BTCs were also understood to do so. The Action Group considered the practice to be highly questionable because of the number of homosexuals and the extent of homosexual activity in prisons and the present unease about the incidence of AIDS among that group. The note sought advice on departmental policy on the practice of collecting blood from prisons and borstals.

5.65 On 23 August 1983 P A Winstanley of the DHSS replied to Mr J B Brown.[65] The note stated that it was very difficult to advise any particular departmental policy on the collection of blood from borstals and prisons. It was for individual regional transfusion directors to determine how, and from where, donations were sought in the light of the targets they needed to achieve and the numbers of donors on their panels. However, transfusion directors had been aware of the dangers of relying too heavily on prisons as a source of donations for some time, ie prior to the advent of AIDS, because of the risk of hepatitis in prisons (also connected to the higher incidence of homosexuality) which could be spread through blood transfusion. Nevertheless, although most regions, especially those with no shortage of donors, may not need to use prisons, there was at least one which had to view them as a major source of donations in order to meet targets. The note went on to state that AIDS had now called even further into question the wisdom of continuing to view prisons as a source of blood, and the directors were due to discuss it at their next meeting in September. If the risks were now considered too great to justify continued collection from prisons, some measures would be needed to compensate for the loss of that source of donors. The note finished by stating that: ‘We shall obviously need to liaise closely with [the] Home Office also since they have in the past been very much in favour of blood donation by prisoners.’

5.66 On 23 August 1983 Dr Brookes wrote to Dr Cash.[66] The Working Party on the Selection of Donors/Notes for Transfusion had met on 30 June. On the question of donor sessions at prisons and borstals Dr Brookes said: ‘You asked me to discuss this with my colleagues. In 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.’

5.67 On 24 August 1983 Dr ADD Forgan (Dundee, SNBTS) wrote to Dr RJ Perry, PFC, advising that two blood donations from a prisoner who had previously tested negative for Hepatitis B surface antigen, which had been included in plasma for fractionation, had tested positive for antibody to Hepatitis B core antigen.[67] Concern was increased as it was believed that the Aberdeen centre had information that implied that the donor was not giving a frank or consistent account of his history and that he was currently positive for Hepatitis B surface antigen.

5.68 On 13 September 1983 the SNBTS directors met.[68] There was discussion of the ‘Guidance on the Selection of Donors and Notes for Transfusion’ produced by Dr Entwistle’s working party. The Medicines Inspectorate’s concern at the practice of collecting blood in prisons and borstals was noted, as was the inability of the directors 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 (Dundee, SNBTS) 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 blood from prisons and borstals and that cessation of the 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’ of good manufacturing practice. Dr Brookes undertook to circularise the English/Welsh directors and report back to the SNBTS directors.

5.69 On 8 December 1983 the SNBTS directors met.[69] Dr Brookes reported on her consultation with the English/Welsh transfusion directors concerning collections in prisons and borstals. Only one of the 12 RTCs which she had consulted was attending prisons. The only Scottish region to continue holding sessions in prisons was Glasgow and West of Scotland BTS.

5.70 On 9 February 1984 the National Institute for Biological Standards and Control met to discuss the infectious hazards of blood products.[70] In a discussion on policies adopted in Scotland to minimise the risk of transmission of infection, one of the main strategies was noted to be ‘avoidance of high risk communities (such as prisons …)’.

5.71 In July 1984, Dr Follett (Regional Virus Laboratory, Ruchill Hospital, Glasgow) and Dr Dow (Glasgow, SNBTS) produced a final report on their three-year research project, ‘Non-A, non-B hepatitis in the West of Scotland’.[71] Of the 10,655 donations tested in the study, approximately one half (5057) were from prisoners. Screening of blood from prisoners detected 10 times more donations with grossly elevated alanine aminotransferase (ALT) levels compared to other donors. The report noted that these results had discouraged the SNBTS from visiting prisons to obtain blood for transfusion purposes.[72]

5.72 In an answer to a parliamentary question on 24 March 1986, Baroness Trumpington, Under-Secretary of State, DHSS, advised that regional transfusion directors in England and Wales had clinical responsibility for the acceptance of blood donors and that they did not collect blood from groups known to be at risk from certain diseases.[73] RTDs in England started to phase out collecting blood from prisoners in 1980. Among the factors which had been taken into account was the large number of donations from prisoners that routine screening for hepatitis showed could not be used. It was also noted that the available tests were not able to screen for all types of hepatitis virus. It was stated that ‘The primary concern of the [NBTS] must be to protect recipients of donated blood.’

Processing and use of donations

5.73 In Scotland, in the year ended 31 March 1975, the sum of the volumes of production of red cell concentrates and of the whole blood issued was approximately the same as the total usable blood recovered on donation. All of the blood donated was initially processed at regional level. By 1990, the sum of the two values amounted to 68% approximately of the total usable blood. The difference reflected the trend towards manufacture of factor concentrates and more specialised products and the provision of plasma to PFC for that purpose.

5.74 The Regional Blood Transfusion Centres carried out a range of procedures locally. Changes in these procedures reflected changes in clinical practice. The use of red cell concentrates in transfusion, rather than whole blood, increased, reflecting the shift towards component therapy. The corollary of the reduction in the percentage of total usable blood represented by the sum of production of red cell concentrates and the whole blood issued, was the transport of fresh frozen plasma and other components to PFC, Liberton, for processing. But that did not exceed ten per cent of total usable blood until 1985–86, which had a limiting impact on PFC’s production capacity as appears later.

5.75 There were increases in the use of other components and products over the same period. Processing at regional level included the centrifugation of whole blood to separate out and concentrate the principal cellular components, including red cells and platelets, and some fractionation to produce cryoprecipitate in particular. The red cell volumes, as the first component separated by centrifugation, together with the falling quantities of use of whole blood, provide a ready measure of the change in emphasis over this period. It was anticipated at the beginning of the period that this trend would continue, and that it would not only reflect good transfusion practice, for a large proportion of patients, but would increase the production of fresh frozen plasma which was a vital requirement for the production of Factor VIII concentrates.[74] At the time, the production of frozen red cells was limited by cost and the time required for processing. Some production was recorded in 1975–76 and subsequent years, but the volumes were small.

5.76 The production of cryoprecipitate at Regional Blood Transfusion Centres fell as a percentage of total available blood. But it remained a significant factor, reflecting clinical use of that product over the period.

5.77 The change in transfusion practice from the use of whole blood to the provision of component therapy, so that the patient received only those components of blood which they lacked, was in progress by the beginning of the reference period. The changed practice was thought to enhance safety in transfusion procedures, and to enable the optimum use of blood donations.[75] It also reflected the development of sophisticated technology capable of processing the raw materials provided by whole blood donation and, increasingly over time, apheresis. In an undated report prepared for the Medical Research Council’s Transfusion Research Committee, and made available for a meeting of SNBTS and haemophilia directors on 26 November 1973, Dr Rosemary Biggs and others stated:

‘Several developments in recent years have tended to alter the traditional image of the transfusion service as a purveyor of whole blood. For many surgical and anaemic patients packed cells may be equally as effective as whole blood. Fractions other than factor VIII are also very valuable for example, platelets, concentrates containing factors II, IX and X, immunoglobulin and albumin. In the present communication the needs of the haemophilic population have been highlighted but in the future the rational use of all human blood products may become the most important priority of the transfusion service.’ [76]

5.78 The treatment of haemophilia patients had progressed initially from the routine use of whole blood to fresh frozen plasma; then from about 1961, to AHF, Cohn fraction 1; between 1966 and 1968[77] to cryoprecipitate[78] and finally, to improved factor concentrates, beginning in 1972–74.[79] Understanding the pattern of treatment of haemophilia patients in the United Kingdom in general and in Scotland in particular in the later 1960s and early 1970s is bedevilled by a number of complex variables. There were changes in the units of measurement of therapeutic doses of Factor VIII: ‘donor units’ and ‘donation equivalents’ gave way to ‘units of Factor VIII activity’, defined as ‘the amount of activity in 1 ml of average normal plasma’, and there were varying and irreconcilable differences in the conversion factors used to express quantities as between the two. There were differences in nomenclature. It appears that what Biggs called ‘NHS Factor VIII’, Cash and Spencely called ‘Anti-haemophilic factor’ or AHF. Developments in Cohn fractionation technology varied in different centres between about 1960 and 1976, affecting the product.[80] And, within the United Kingdom as a whole, there were geographical variations in the use of ‘NHS FVIII Concentrate’ or ‘AHF’ on the one hand and cryoprecipitate on the other which were apparently related to the proximity of a particular centre to a plasma fractionation unit.[81]

5.79 Subject to the uncertainties that necessarily arise in these circumstances, UK demand for cryoprecipitate appears to have remained strong until 1974, varying over the period between 1969 and 1974 from 68.9% of total Factor VIII to 70.29%, having peaked in 1970 at 76.04%. Total demand for factor concentrates (including commercial products) in the United Kingdom over the same period varied from 25.97% to 26.34%, and within those values the emphasis moved strongly towards commercial Factor VIII. In addition to growing demand, which clearly affected the shift in the market, the manufacture of factor concentrates, and in particular Factor VIII, proved to be difficult. Factor VIII yields were low, capacity was limited in the United Kingdom, including Scotland at least until PFC Liberton was fully in production and had an ample supply of plasma, and there was insufficient to meet increasing patient demands.[82] It was necessary to rely on imported commercial products.

5.80 But the political ambition, internationally and domestically, remained to achieve self-sufficiency. The Council of Europe, Council of Ministers, Recommendations No R(80) of 30 April 1980 ‘Concerning blood products for the treatment of haemophiliacs’[83] stated that member states should pursue the goal of self-sufficiency of anti-haemophilia products and blood plasma for their preparation. The Recommendations acknowledged the fact that both the geographical origin and type of donor population had a significant effect on the risks of infectious diseases.

Fractionation practice

5.81 As noted in the introduction, at the beginning of the reference period, the method of preparing Factor VIII concentrates used in Edinburgh was based on the work of Dr Alan Johnson.[84] Shortly before the beginning of the reference period, Dr Johnson and his co-workers developed methods for the production of Factor VIII concentrates of intermediate and high purity. [85] The paper published in 1971 gave wide circulation to the methodologies involved. SNBTS (PFC) collaborated with Dr Johnson in order to introduce the American technology into the UK.

5.82 This was a time when, as described above, demand for blood products for the treatment of haemophilia patients in Scotland (in common with the rest of the UK) continued to grow rapidly each year.[86] The SNBTS, and their colleagues in England and Wales, had difficulty in planning to meet the increasing demand. Analysis by product showed the use of fresh frozen plasma increasing slowly until 1970 after which it fell dramatically.

5.83 Use of Factor VIII (initially in fresh frozen plasma, subsequently as cryoprecipitate or concentrate) fluctuated. Cash & Spencely published data in graph form for the south east of Scotland tracing movements in use between 1961 and 1974. According to that source, use of fresh frozen plasma remained fairly steady until about 1970 when there was a fall to a new, near zero, level for the rest of the period. AHF use progressed between 1961 and 1972 followed by a fairly dramatic reduction until 1974, after which there was a small increase. The use of cryoprecipitate did not register on the graph until 1970 when it began to rise dramatically until 1973 when growth slowed.[87] It was recognised that supplies of Factor VIII in Scotland as a whole were limited and what was available was used sparingly and tended to be channelled to particular patient groups. Before PFC Liberton came fully into production in 1976, Scotland did not produce adequate supplies of Factor VIII concentrate for self-sufficiency.

5.84 At the same period, in relation to the production of Factor IX concentrate, scientists in Scotland produced a Factor IX preparation, DEFIX, for home consumption in the treatment of clotting deficiencies. They also participated in a collaborative project with scientists at New York University, the ‘Supernine Project’, which aimed to replace the then-current preparation with a concentrate that would be three to five times more potent, and have a reduced risk of transmitting Hepatitis B. The participants in the project were J K Smith and S M Middleton of Edinburgh; and, once more, A J Johnson of New York University.[88] The research drew attention to other causes of infection. Tracing the course of that research, research into related scientific and technological topics, and research into HIV/AIDS will occupy much of this report. However, it must be understood that, in the early 1970s, there was much to be discovered about the hepatitis viruses generally. HIV/AIDS was as yet unknown. It would be misleading to present the position at 1 January 1974 as reflecting a steady state of knowledge. There was increasing sophistication in the manufacture of products. There was increasing understanding of the uses to which specific products could be put. That would be the position going forward.

5.85 Dr Biggs and her colleagues gave an account of practice in England and Wales during the period 1969 to 1972. Freeze-dried concentrate was manufactured using a modification of the Newman method. As at March 1976, this was based on the methods of Newman and James and Wickenhauser.[89] Technological procedures were developed using different chemicals and, in particular, using heparin as a stabilizer. Dr Rosemary Biggs and other workers at the Blood Coagulation Research unit at Oxford,[90] and later Dr Edith Bidwell and other workers from the same team,[91] published papers on this work. The procedures permitted the preparation of both Factor VIII and Factor IX from the same batch of plasma. So far as Factor IX was concerned, the result was a very high-purity product.

5.86 There was close collaboration in research between the services in England and Wales on the one hand, and Scotland on the other, in the 1970s. Each sent samples of developing products to the other for trial, and there was a ready exchange of technical information. This was to change over time. But these practices formed an important part of the background to the development of major facilities for the production of blood products before and in the early years of the reference period.

5.87 The general trends in scientific knowledge and technological progress ensured that production facilities in the public sector capable of contributing to, and reacting to, research and development in the area had to become more centralised.

Production facilities

5.88 By the beginning of the reference period, the scope of the operations planned for the new Scottish facility at Liberton in Edinburgh had changed considerably from those originally envisaged. Production at the Edinburgh Royal Infirmary site had progressed beyond the preparation of freeze-dried plasma, cryoprecipitate had become a mainstay of haemophilia therapy, and factor concentrates were beginning to have an impact on the market. Nevertheless the basic aim of having two public facilities for the United Kingdom was pursued, and was to be realised at or about the beginning of the reference period. Planning for the Scottish facility proved to be a tortuous process, most aspects of which are of little interest. There are, however, a few matters that were important as planning was completed and the construction and commissioning of the plant began.

5.89 Two of those matters were the planned territorial scope of the Scottish facility’s operations, and the target volumes of production. It seems likely that a number of considerations affected the 1969 estimate of demand. One matter affecting the reliability of the assessment of demand was exposed in the report presented by Dr Biggs to the MRC in 1974, and repeated with reference to a later period in a report on behalf of the haemophilia reference centre directors published by Dr Biggs and Dr Spooner in May 1978.[92] The 1978 report noted that data from 1974 implied that patients with haemophilia were attending hospitals which were not recognised as haemophilia centres under the designation scheme that had been in place since the mid-1950s. A survey was carried out. It disclosed a significant number of cases of treatment in hospitals that were not designated. The report observed that all severely affected patients would require frequent antihaemophilic treatment annually, most of the moderately affected patients would require treatment two or three times a year, and that many of the mildly affected patients would require treatment at least once a year. The directors were concerned that a large number of patients with Haemophilia A or B were not seen at a haemophilia centre to establish a diagnosis.

In their opinion any patient who has a coagulation defect should be seen at a haemophilia centre to establish a diagnosis. To ensure a suitable supply of therapeutic material and the highest standard of treatment available, the care of these patients should also be coordinated by a haemophilic centre.

5.90 The authors’ primary concern was for the welfare of the patients. But the information required to prepare a valid projection of overall need for therapeutic material was deficient. That deficiency continued to be as significant in 1974, as it had been when assessing demand several years earlier.

5.91 Other workers commented on factors that were creating increasing demand at about this time. Home treatment increased demand for factor concentrates in 1975 and 1976.[93] Dr Jones and co-workers at Newcastle examined data from all UK haemophilia centres and provided a picture of growth, from very early cases in 1960, and from the introduction of cryoprecipitate in 1964, but more particularly in 1975 and 1976. Over those two years, the number of patients on home treatment, or in training for home treatment, rose from 267 to 488. In addition the directors of the centres estimated that 280 additional patients were awaiting entry to the scheme in 1975 and 241 in 1976. The products used included cryoprecipitate and factor concentrates, and the latter included a wide range of commercial products. Dr Jones and colleagues reported a significant rise in demand due to the number of patients involved; the variables in assessment of effective dosage; the use of prophylaxis; and the adequacy of supply. They commented that the demand in the UK as a whole could not have been met without recourse to commercial Factor VIII concentrates. About 55% of the blood product used for home treatment was imported, and necessarily so, because of the continued fall in production of NHS concentrate from voluntary donations.

5.92 Dr Jones continued to promote the benefits of home therapy, inter alia by editing a handbook for those involved in treatment and for patients, that was published by Pitman: ‘Haemophilia Home Therapy’.[94]

5.93 Meanwhile, planning of the Scottish facility proceeded on the same general basis as the original forecasts. In November 1969, there was a meeting at Edinburgh Royal Infirmary (ERI) between the SHHD and the Blood Transfusion Services of England and Scotland.[95] It was reported that the new Scottish fractionation centre had been approved at a cost of £1.5 million, but that it would be about one year before contractors could move onto site; it was estimated that commissioning would be completed in the latter half of 1974. Building of the new extension at Elstree had begun in November 1969 at a cost of about £1 million.

5.94 In July 1971, there was a further meeting at ERI between the SHHD and the Blood Transfusion Services of England and Scotland.[96] Tenders had been submitted for the new Edinburgh fractionation centre and building was expected to begin on schedule, with commissioning beginning in January 1974. Completion of the Elstree extension was expected by September 1971. It was agreed that discussions on central processing of Factor VIII and Factor IX concentrates was imperative because of major effects on production planning. Work began at Edinburgh with a planned commissioning date in January 1974,[97] which coincided, in the event, with the start of the reference period for this inquiry.

5.95 In March 1973, there was a meeting at Elstree between the SHHD and the Blood Transfusion Services of England and Scotland.[98] Good progress was reported in the construction of the Edinburgh fractionation centre, with commissioning expected to start in April 1974. The work was completed at the end of 1974.[99] The total cost was expected to be just over £1million. But there was still a degree of uncertainty about the scope of the plant’s operations. It was noted that capacity for the fractionation of English plasma in Scotland did not include the production of coagulation factors. This matter was to be considered further by the DHSS for the UK as a whole. However, it may be a matter for comment that, at this stage, when the use of coagulation factors was increasingly seen as of central importance in the treatment of haemophilia patients, the final planning of the Edinburgh facility was being completed without a decision on this critical aspect of the facility’s function.

5.96 By the beginning of the reference period, therefore, the decision to build a fractionation centre at Edinburgh had been implemented: the new plant was due for commissioning imminently. But the production targets and the scope of operations continued to be open for discussion. There was no concluded policy as to the extent of the facility’s use, especially in relation to the processing of material from England and Wales. However, events were to render that more or less irrelevant. The Annual Report of SNBTS for the year ended 31 March 1976 referred to some of the issues. The plant had been designed to accommodate material from England; staff had been recruited and trained on the basis of shift-working to realise the plant’s production potential. But opposition from the trades’ unions, allied with demands relating to terms and conditions of employment which the employers found unacceptable, had made shift-working impracticable.

5.97 Some English plasma was dispatched to Edinburgh once the facility was commissioned. On 11 April 1977, Mr John Watt reported to SNBTS that he held 10,000 litres of plasma from England, but did not have any arrangement in place for processing it. By July, the quantity had increased to 20,000 litres. The minutes of a meeting of SNBTS Directors on 12 July 1977 noted:

Mr Watt referred to the 20,000 litres of plasma he had in stock which BPL Elstree had asked him to fractionate and expressed disquiet at the proposal that he should receive plasma from BPL and deliver fractions to a DHSS store in Bristol, thus divorcing him from contact both with the supplier of the plasma and the users of the fractions. While Mr Watt would have preferred to return to the original proposal that he should collect plasma from, and deliver fractions to, nominated BTS regions in the North of England, he agreed that contact with the supplier of plasma only would be acceptable. Directors agreed that a system acceptable both to BTS England and Wales and to SNBTS would have to be evolved and that this should be borne in mind by those presently negotiating the supply of plasma from England to PFC.[100]

5.98 It was noted that production of Factor VIII was continuing at a rate of 2000 doses per quarter.

5.99 The minutes of a meeting of SNBTS directors on 17 January 1978, at Item 3 b, again dealt with processing of plasma from BPL Elstree:

Mr Watt reported that the plasma mentioned at the last meeting was still in store. It was agreed that no start should be made on large-scale processing of plasma from England and Wales until a plan had been drafted and agreed by Transfusion Directors both north and south of the border. Such a plan should be drafted by the Joint Committee on Blood Products Production. It was generally agreed that Scotland should secure its own supply of fractions before undertaking work for NBTS. Pending an agreement on shift working Mr Watt felt he could process a limited amount of the plasma from BPL on the basis of an extended working day, to ascertain the yield and establish costs. Directors agreed that he should do so, possibly devoting two weeks to fractionating English plasma only.[101]

5.100 It appears that there was a Joint Committee on Blood Products Production involving the Scottish service and that of England and Wales. But its work had not resolved these basic issues by this time. In the event, it was decided that PFC Liberton could deal with Scottish needs using day staff only, but could not take plasma from furth of Scotland. For the time being at least, PFC Liberton would service the Scottish market alone.

5.101 The final stages in the planning of the new Edinburgh facility therefore took place against the background of a fairly dramatic failure fully to understand and to provide for the levels of demand for coagulation products in the United Kingdom generally, at a time when demand was increasing rapidly, and without firm arrangements for the optimum use of the facilities planned.

5.102 So far as Scotland was concerned, there was no basis on which it could have been concluded at the beginning of the reference period that the country was or would be self-sufficient in Factor VIII blood products until the Liberton facility was fully operational. Progress towards self-sufficiency thereafter would depend on policy decisions, and on raw material supplies, to meet processing targets that were yet to be set and implemented. However, at this time there was a lack of confidence about the future. On 8 May 1975, the SNBTS and haemophilia directors met with SHHD officials.[102] Officials were conscious that, in advice on parliamentary questions, ministers were constantly being informed that, when PFC was fully commissioned, long-term supplies of Factor VIII concentrate would be assured. It was observed that it was still not clear what the timetable was for the replacement of cryoprecipitate by concentrate. The minutes of the meeting disclose little hard information, and expose wide-ranging doubts. No firm conclusions were reached on future demands. At the following meeting on 14 November 1975, there was little progress on demand. A study group was set up, convened by General Jeffrey,[103] and a pro forma prepared for the collection of data.

5.103 The Annual Report of the SNBTS for the year ended 31 March 1976 reflects the developing position at the time. The commissioning of PFC was almost complete, and full production to meet Scottish needs was said to be in sight, provided that appropriate supplies of plasma were forthcoming from the regions. A manufacturer’s licence under the Medicines Act 1968 had been granted, and applications for product licences for each individual preparation were either prepared or in draft. As events were to unfold, it would be several years before the supply of plasma from the regions took up PFC’s production capacity.

5.104 More generally, there was explicit acknowledgement that Scotland was in part dependent on imported products prior to the full commissioning of PFC Liberton. On
11 June 1975, at a meeting of SNBTS directors, the purchase of commercial blood products was raised as a procurement matter, implying acceptance of purchase in principle:

In response to a query from Dr Cash, General Jeffrey explained that SHHD had under urgent consideration the issue of whether commercially produced blood fractions which might be required should be purchased by SNBTS or by Health Boards.[104]

5.105 On 30 September 1975, at a subsequent meeting of SNBTS directors:

It was explained that, because of the comparatively minor nature of the problem, it should be left to Directors to purchase and distribute human blood products should this prove necessary. This was an ad hoc arrangement pending full commissioning of the PFC.[105]

5.106 It appears to be clear that until full commissioning of PFC Liberton, the production of Factor VIII in Scotland as a whole was not sufficient to meet Scottish needs. Commercial purchases were not centralised, and it was left to local health boards and their officers to purchase and distribute commercially produced blood fractions as required. This became a factor of some importance in relation to the assessment of total demand, and in particular, to the assessment of the production requirements at PFC Liberton. In one of two ‘World in Action’ television programmes broadcast in or around the end of 1975, Mr John Watt of the SNBTS stated that, with sufficient plasma supplies, the PFC, Edinburgh could supply Factor VIII concentrate for about half of the needs of the haemophiliacs in Britain.[106] However, its capacity was not fully utilised: the intention to process plasma from England was never realised. Mr Watt’s interview caused concern. In a letter to the British Medical Journal dated 24 January 1976, Dr Cash commented that editing of material provided had created a misleading impression. He wrote:

Perhaps the most important misleading feature of the second television programme was the impression given that the recent and specific injection of £500,000 into the blood transfusion services will have worked its way through by mid-1977, and by that time the necessity to purchase further supplies of factor VIII concentrates will be eliminated. Our own experience indicates that this will not occur, not least because the present NHS production target for factor VIII concentrates is too low. What seems more certain, however, is that by mid-1977 we shall begin to understand that the problems are multifactorial, a good deal more complex than hitherto appreciated, and only partly related to the haemophiliac….

5.107 The failure to provide for total demand and the implied acceptance that the UK was heavily dependent on imported products were factors clearly acknowledged within the service throughout the United Kingdom.

5.108 As already mentioned in the Introduction, Dr Cash and Dr Spencely returned to the issue of demand for Factor VIII products in September 1976.[107] They expressed concern about the forecasts based on the Medical Research Council’s research in 1974,[108] because of the wide range of values brought out. In their study in the south-east of Scotland region based on treatment between 1961 and 1975, they had found a substantial increase in the donations required for Factor VIII production over the period, and noted:

From 1961 to 1963, about 1300 donations were required each year, but in 1964 demand increased abruptly with the introduction of major reconstructive surgery and reached a new plateau by 1970, at about 2750 donations. Subsequent sharp increases were due to the gradual introduction of on-demand treatment. Particularly important, however, was the fact that by 1973 this programme was available to all patients, and since that time no further increases in demand have occurred. This suggests that a saturation level may have been reached.... No commercial preparations of factor VIII were used to supplement this programme.

5.109 There are several features of these comments that deserve note. The projection of saturation was, superficially at least, very odd. Given the increase in life expectancy, and the concomitant extension of the term of treatment of the average haemophilia patient, one would have expected a rising trajectory even if all other factors had remained constant: treatment years per patient had to increase. In the final sentence, the authors indicate that no commercial products were used in south-east Scotland over the period of the study. This was in marked contrast to other parts of Scotland at the time. Further, in a paper published in 1976,[109] the Health Services Operational Research Unit of Strathclyde University cast doubt on the notion that commercial purchases were a minor issue at the time. It set out the quantities of therapeutic materials administered at Glasgow Royal Infirmary in the period 1 March 1971 to 28 February 1974 as follows:


33,904 packs

Whole blood

182 donations

Fresh frozen plasma

41 donations of blood

Washed packed cells

12 donations

Antihaemophilic factor (Cohn factor 1)

140 donations

Kryobulin Factor VIII

12,185 units of Factor VIII activity


4,152 units of Factor VIII activity

Edinburgh Factor VIII

988 units of Factor VIII activity.

5.110 Cryoprecipitate was the main product administered during the period, reflecting clinical preference in the area. But within the class of concentrates, the quantities of imported commercial products were significant. This was the period when the Edinburgh Royal Infirmary pilot project was coming to an end and when preparations for the transfer of operations to PFC Liberton were in hand. But, subject to the qualifications this implies, imported material was making a significant contribution to demand.

5.111 The views set out by Cash and Spencely in this paper were not accepted universally. In the paper, they commented at some length on the choice of therapeutic materials, and the efficiency of production of cryoprecipitate as against concentrate. But it is in the discussion of the estimation of demand that the paper is particularly interesting for present purposes:

We have found the figures reported here valuable in planning our own activities. Extrapolation to national figures, and also to other regions, however, must be approached with some caution, with respect to both the absolute number of donations required and the specific factor VIII consumption …Firstly, although our figure of six haemophiliacs/100,000 population is likely to be similar in other regions, the proportion of patients with severe haemophilia in south-east Scotland may be higher than in other parts of the country. Secondly, the average dose of cryoprecipitate administered to these patients attending each on-demand outpatient visit was eight donation equivalents (about 960 units of factor VIII), and this amount of factor VIII may be higher than that used in some haemophilia centres. On the other hand, during 1973–75 there were no demands for major reconstructive surgery, no other elective or emergency general surgical procedures, and no patients with inhibitors treated with large amounts of factor VIII.

Hence we have concluded that the blood transfusion services should consider a production target of an average of 15,000 units of factor VIII/patient/year with a total UK annual requirement of around 50 million units. Regionally we should aim to process at least 12,000 fresh donations/million people/year. Those regions with a smaller proportion of patients with severe haemophilia than our own should find this will cover all contingencies. If nearly half the haemophiliacs have severe or moderate disease or much reconstruction has yet to be done, or both, then 15,000 donations may be more realistic. These calculations are based on the assumption that 70% of the concentrate used is cryoprecipitate, which is by most standards a high yielding product. Any movement towards completely replacing cryoprecipitate by AHF, unless counterbalanced by reducing the dose of factor VIII at treatment, will, because of diminishing yields, necessitate a substantial increase in donations. A more appropriate figure in these circumstances would be 20,000 donations/million population/year. This figure would rise further if the volume of fresh plasma obtained from each donation was reduced, something that is already occurring with the increasing introduction of red cell concentrates…as a replacement for whole blood. It is difficult not to conclude that a programme designed to switch completely from cryoprecipitate to AHF will prove to be too costly and wasteful of raw material for the next decade. Consideration should instead be given to striking a balance between both products and perhaps even rethinking the cost-effectiveness of freeze-dried cryoprecipitate.

The real difficulties seem to lie in developing a strategy aimed at making the blood transfusion services more responsible for all aspects of blood component treatment. Clearly the amount of plasma currently available falls short of what is required, and we shall see the emergence of albumin as the blood product that dominates the raw material requirements. Thus factor VIII concentrates should become a plentiful by product of modern fraction techniques. This complex problem will have to be considered carefully, for more money is urgently required over the next five years. This should be seen by government departments as an important long-term investment in an organisation closely allied to the pharmaceutical industry. The return on this investment over the next 20 years will be so great that undue delay now may be a serious error of judgment.

5.112 It appears to be clear that at the date of this paper, September 1976, with the commissioning of PFC Liberton, the authors believed that the south-east of Scotland was self-sufficient in therapeutic Factor VIII products. But there remained considerable issues about the rest of the country. It was recognised that supplies of AHF were limited: ‘What supplies of AHF there are, should be reserved for outpatient use, while cryoprecipitate is used for inpatients.’ The conclusion was:

In the meantime the blood transfusion services ought to look towards improving the quality of cryoprecipitate production and procedures for the procurement of bulk fresh plasma. The plasma fractionators should look towards technical developments that will lead to improved yields, the general hospital medical staff towards a dramatic increase in the use of red cell concentrates and packed red cells in preference to whole blood, and the staff of regional haemophilia centres to the more economical and critical use of factor VIII concentrates…. There is no evidence to suggest that the voluntary blood donor will not respond; indeed those in the regional blood transfusion centres know that quite the reverse is true.

5.113 It is implicit in the proposals for restricted use that there were deficiencies. Any deficiencies in domestic supplies could only have been made up by the purchase of commercial products. Of possibly greater significance, so far as developing a strategy for self-sufficiency is concerned, is the clear message that there was no settled practice governing the choice of product for well recognised categories of application. In particular, the factors identified as relevant to the choice of product were related to the economics of manufacture, yield pre-disposing the authors to recommend cryoprecipitate in preference to Factor VIII concentrates, and red cell products to both. The paper did not distinguish among the various products on the basis of viral infectivity, which, at this stage, was not identified as a distinguishing characteristic.

5.114 In a paper prepared for a meeting of SNBTS and haemophilia directors on 4 October 1976, the data required to assess resources for the adequate treatment of Scottish haemophilia patients were set out in some detail.[110] There were 436 registered haemophilia patients. Twenty to 22 of these required treatment three or four times a year. Eighty seven to 92 required more frequent therapy. The rest hardly ever required treatment or required it not more than twice a year. The data were not entirely reliable because of the practice of some patients of attending general hospitals. Factor VIII usage in the first six months of 1976 gave a clear picture of the current position:






Cryoprecipitate as donations






PFC Factor VIII: vials



(307,700 u)




Commercial Factor VIII




(90,740 u)


5.115 The figures compared with total cryoprecipitate of 26,616 donations and PFC Factor VIII of 1023 vials in the full year 1975. The minutes of the meeting reflect the concern at UK level over the accuracy of estimates of demand, and at the difficulty and cost of maintaining accurate registers of use.[111] Two points were noted as being of particular concern: the increasing needs as a child grew older, and the increasing prospects of longevity. The wider context was reflected in two paragraphs, the first of which (paragraph 7) said:

The primary need was seen as the provision of information to help on balancing use and requirements. Use would obviously increase if patients took up and were encouraged to take part in eg skiing or other outdoor pursuits. It was becoming increasingly apparent that haemophiliacs should be advised to live within the limits of their disability and in the more severe cases this could lead to them living a more sedentary life. While it was acknowledged that this is a difficult area, impinging as it did on the question of clinical freedom, it was thought to be a realistic approach.

The following paragraph (paragraph 8) proposed a meeting with the Haemophilia Society with a view to discussing the use of the scarce resources available and other topics on a UK basis that might lead to the production of a UK register among other things.

5.116 An exploratory meeting of blood transfusion directors and haemophilia reference centre directors was held in Sheffield on 22 October 1976.[112] Dr Biggs presented the data on need, estimated at 40million units of freeze-dried Factor VIII. International data suggested a need for England, Wales and Northern Ireland of 36,481,890 units, and for Scotland 3,741,917 units, giving 40,223,807 units in total. These figures presented a picture of spurious arithmetical accuracy, but they agreed fairly well with estimates based on UK data. She anticipated a shift from the use of cryoprecipitate to the use of concentrates, noting that five commercial companies were licensed to supply very satisfactory products which offered convenience in use.

5.117 In discussion, Dr Biggs is reported to have commented that 40million units was too low an estimate for the future because use was increasing. Dr Cash agreed. He was alarmed by the games and sporting risks now covered and the implications for demand: it was morally wrong to commit such large amounts of material. Dr Wallace worried that the Scots were in danger of taking over the meeting, and pressed for a common policy, but he too reflected the view that haemophilia patients should live within the limits of their disabilities. Dr Jones was of a different view, encouraging normal sporting activities such as football: if patients sat around they would need more therapy. He proposed a target of 42.4 million units. Following extensive discussion, the final proposal, from Dr Prentice, was that the current target was 40 million units, rising to 50 million units over the following three years. This was an open, uninhibited, discussion among experts. The minutes contrast well with those of meetings chaired by officials, but there were doubts about its usefulness.[113] The fractionators were not in agreement about the criteria to apply and about the practical implications of working to the targets proposed.

5.118 At a meeting of SNBTS directors on 26 October 1976, in discussing the supply of Factor VIII concentrates, it was noted:

Dr Wallace, Dr Cash and Mr Watt had attended a meeting of English transfusion directors and haemophilia reference centre directors at the Sheffield Blood Transfusion Service on 22 October. They had concluded that, although Scotland’s problem was smaller than in England and Wales, there was still a long way to go towards setting ultimate targets for the production and use of Factor VIII products. It was agreed that a firm attempt should be made at the meeting of the haemophilia directors planned for 24 January 1977 to set interim Scottish targets.

5.119 The October meeting had not resolved targets. Dr Cash and Dr Spencely had not in their paper resolved the issue of methodology to the satisfaction of United Kingdom colleagues. Estimates of demand remained uncertain. The paper’s projection of total UK demand at 50 million units exceeded Dr Biggs’ estimate of 40 million, but reflected the longer term projection for the UK as a whole. But each projection exceeded by a considerable margin the production targets on which the two major facilities were planned and constructed or developed at this time.

5.120 In the event, in the United Kingdom as a whole, there was an emerging shortfall in production of growing significance. The inability of domestic production to meet demand was reflected in the reported use of commercial Factor VIII concentrate. Zero use was reported until 1971. Thereafter, demand for commercial material was reported as follows:



Percentage of total Factor VIII













5.121 The figures reflect a material failure at the beginning of the reference period in the planning of production capacity, to anticipate the actual emerging levels of demand; and a correlative failure to provide production facilities in the United Kingdom with the capacity to service domestic requirements. If it were accepted that cryoprecipitate accounted for 70% of total Factor VIII used in about 1975 (the view of Cash and Spencely in their paper published in 1976), commercial concentrate would have amounted to two thirds of the total concentrate used in 1975.

5.122 In a letter to The Lancet of 29 June 1974, Dr Biggs wrote:

Those who treat haemophilic patients in the United Kingdom have in the past of necessity tolerated the chronic undertreatment of their patients and have put much time and effort into spreading the inadequate amounts of therapeutic material thinly so that deprivations should be least damaging. Essential but non-urgent operations have been postponed and are still being postponed. Economy has also been achieved by calculating the dose for each lesion for every patient to give the absolute minimum dose. In addition patients have not been put onto home therapy who would greatly benefit by this treatment…. There is, in fact, evidence that 90% of haemophilic patients in the United Kingdom receive less (and in some cases much less) than optimum treatment for their complaint. The consequences of this undertreatment include subjecting the patients to unnecessary, painful and destructive bleeding into joints and muscles. Ancillary effects of undertreatment include loss of educational time and inability to hold continuous employment.

5.123 Dr Biggs proceeded to make an emotional appeal for the purchase and use of stocks of ‘good quality human Factor VIII’ readily available from commercial companies that were by then licensed to make supplies in this country, and dismissed, rather contemptuously, all arguments based on financial constraints. She concluded:

Whatever solutions there may be for problems of this sort in general, some immediate solution should be found for the ridiculous impasse of large available stocks of therapeutic materials locked up in stores because no-one will buy them and, on the other hand, patients in dire need of this same material.

5.124 The large increase in the use of commercial products shown in the table above may suggest that there had already been some movement in the direction sought. However, at least so far as England and Wales were concerned, her comment underlines the deficiencies in domestic production.

5.125 It appears to be clear that the problems that preoccupied the medical profession and the technologists associated with blood product production in the mid to late 1970s related to production capacity, cost, and adequacy of therapeutic materials for appropriate treatment of the patient population. Awareness of Non-A Non-B Hepatitis (Hepatitis C) was an emerging issue: AIDS was yet to appear. As the 1980s progressed, the emphasis was to change dramatically.

5.126 The changes in production facilities and practices are dealt with in the context of trends in demand for and use of blood products. But there are a number of points of general importance that should be made at this stage, since they emerge from the discussion:

• At the beginning of the reference period there was already a well-established claim by haemophilia doctors to clinical independence that extended to the selection of therapeutic products thought best to suit the requirements of the individual patient.

• The independent selection of products did, and inevitably would, reflect convenience of use in the context of changing practice (such as the extension of home treatment) as well as therapeutic effectiveness and safety.

• Since the commercial market to which Dr Biggs referred was largely serviced by foreign pharmaceutical companies, clinical independence and a policy of national self-sufficiency in blood products were bound to come into conflict.

• Unless the fractionators had full knowledge of the total demand for the current groups of therapeutic products required for effective treatment of patients, and of the proportion of that demand likely to be met by commercial purchases, effective planning of the production targets and production plant and processes required by the fractionation centres was unlikely to be achieved.

• While that would have been the case in a static market environment, the added elements of technological change and changing patterns of demand would inevitably add to the complexity of the problem of servicing the market.

• Technological development in public sector facilities, dependent on public funding, was likely always to be at a disadvantage compared with the commercial sector which could recoup costs from sales.

• Tensions between fractionators and government in budgeting and in finance were inevitable.

• Tensions between fractionators and clinicians were also inevitable unless there was a properly coordinated policy and management framework that was effective to resolve issues and implement solutions to problems as they emerged and were identified.

The final chapter

5.127 The evolving history of blood product production in Scotland will be traced chronologically in this report. However, at this stage it is appropriate to define the end of the exercise. In 1998 the fractionation of plasma from UK donors was banned as a precaution against the risk that variant Creutzfeldt-Jakob disease (vCJD) might be transmitted by blood products. As a result the SNBTS had to import plasma or obtain it from commercial sources. This, together with a move away from human blood clotting factors to synthetic alternatives, contributed to the decision in June 2006 to accept the recommendations of National Health Services Scotland that it was no longer viable to operate the PFC as part of the NHS.[114] At the time the decision was taken production at the PFC had already been suspended due to concerns about quality assurance.[115] The PFC closed in 2008 after attempts to find a private buyer failed.

[1]1 Girdwood “Fifty years of an organised blood transfusion service in Scotland”, Scottish Medical Journal 1990 35: 24-28 [SNB.010.1836]

[2] Ibid.

[3] Ibid.

[4] See below. This method of collection was to become the subject of criticism by the Medicines Inspectorate in 1983. It is understood that the last collection of blood from prisons or borstals was in March 1984 and that since then all blood donations in Scotland have been provided by volunteers.

[5] Dr Peter Foster: Plasma Fractionation in Scotland: Blood Letter Spring 2008.

[6] National Health Service (Scotland) Act 1947

[7] Report [SNF.001.2412]

[9] Ibid.

[11] Present: IS Macdonald (SHHD), Dr Thomson (DHSS), W d’A Maycock, L Vallett (Elstree), RA Cumming, JG Watt (Edinburgh). [SNF.001.2412]

[12] The Blood Products Laboratory, the equivalent facility for England and Wales of PFC

[13] Same parties as 15 excluding Dr Thomson. [SNF.001.2412]

[14] Synopsis of data prepared by P Foster, PFC, 16 July 2001 – minute not available. [SNF.001.2412]

[15] Synopsis prepared from original minutes by P Foster, PFC, on 16 July 2001. Present were DM Pendreigh (SHHD), W d’A Maycock, L Vallett, D Ellis (Elstree), RA Cumming, JG Watt (Edinburgh). [SNF.001.2412]

[16] Report of a meeting of the Haemophilia Centre Directors held on 5 April 1971 at the Oxford Haemophilia Centre. [DHF.001.1811] at 1820

[17] Biggs, Jaundice and Antibodies Directed against Factors VIII and IX in Patients Treated for Haemophilia or Christmas Disease in the United Kingdom, British Journal of Haematology, 1974, 26, 313. [LIT.001.0099]

[18] From its terms, it appears that in this report ‘United Kingdom’ was used accurately to include Scotland.

[19] Haemophilia Treatment in the United kingdom from 1969 to 1974: British Journal of Haematology, 1977, 35, 487. [LIT.001.0159]

[20] Haemophilia Centre Directors’ Annual Statistics for 1975: British Journal of Haematology, 1977, 36, 447. [SNB.001.7011]

[21] A ‘unit’ is defined relative to the material involved. A ‘unit’ of factor VIII is arbitrarily defined as the amount of AHF activity present in 1 ml of normal male plasma: Buchholz: Blood Transfusion: Merits of Component Therapy: The Journal of Pediatrics February 1974 Vol 84 Number 2 page 165. [LIT.001.0141]

[23] Ninewells Hospital was officially opened on 23 October 1974.

[24] National Health Service (Scotland) Act 1972 s19(3) and National Health Service (Functions of Common Services Agency) (Scotland) Order 1974 article 3(a)

[25] Annual Report: In terms of paragraph 3(e) of SI 1974/467 (The National Health Service (Functions of the Common Services Agency) Scotland Order 1974 the Common Services Agency was given the following function: “the provision of supplies of human blood for the purposes of carrying out blood transfusion and related services, including the production of blood fractions”. [SNB.010.3921] at 3922.

[26] For example see Future Management of the Blood Transfusion Service in Scotland. [SNB.002.1645]

[27] Annual Report [SNB.010.3921] at 3941

[28] Report [SNB.002.0832]

[29] Ibid.

[30] Minute of Meeting [SNB.002.4726]

[31] Scottish National Blood Transfusion Service Strategic Proposals Consultation Document Consultation began on 27 May 1998 and ended on 26 August 1998. [SGH.007.2327]

[32] Press release [SGH.003.8451]

[33] Newman J, Johnson AJ, Karpatkin MH, and Puszkin S: Methods for the Production of Clinically Effective Intermediate- and High-Purity Factor VIII Concentrates: British Journal of Haematology, 1971. 21. 1. [SGF.001.1913]

[34] Cash J.D., Spencely M.: Haemophilia A and the blood transfusion service: A Scottish Study. Brit. Med. J. 1976. 2. 682 – 684. [LIT.001.0255]

[35] Biggs R. Haemophilia Treatment in the United Kingdom from 1969 to 1974. Br. J. Haematol. 1977. 35. 487. [LIT.001.0159]

[36] Buchholz: Blood Transfusion: Merits of Component Therapy: The Journal of Pediatrics February 1974 Vol 84 Number 2 page 165. [LIT.001.0141]

[37] It is of interest that in March 1972, John Watt and James Smith, both then of Edinburgh, commented adversely on small scale production of prothrombin complexes as irrelevant to the treatment of live disease and the rational use of national plasma resources.

[38] Based on the comments of Douglas Starr Blood: An Epic History of Medicine and Commerce first edition published in Great Britain in 1999 by Little, Brown and Company, page 224.

[39] ‘The Gift Relationship’ 1997 edition, ed. Oakley and Ashton page 5.

[40]The Epidemiology of Posttransfusion Hepatitis J Garrott Allen: Stanford 1972.

[41]The Epidemiology of Posttransfusion Hepatitis J Garrott Allen: Stanford 1972 page 15.

[42] ‘Blood’ page 223.

[43] The Voluntary Blood Donor; Clinics in Haematology Vol 5 No 1 February 1976. [SNB.011.0550]

[44] Annual Report of the SNBTS for the year to 31 March 1976. [SNB.010.3921]

[45] Annual Report of the SNBTS for the year to 31 March 1976. [SNB.010.3921]

[46] The Gift Relationship page 43

[48] Immunoelectro-osmophoresis testing

[50] [SGH.003.1305] at 1313 and 1316

[54] A sub-group of the Advisory Group on Testing for Australia Antigen

[56] Similar comments about the prevalence of hepatitis B in the general population and in prison populations appeared in a 1984 document, “Guidance for health care personnel dealing with patients infected with hepatitis B virus”. [DHF.001.5367]

[58] [SGF.001.0351] at 0352 and [SNB.008.7582] at 7583

[59] [SGH.003.5059] at page 5

[60] See, in particular, letter dated 5 July 1982, Cash to Watt: [SNB.005.6703]; Response to Inspectorate dated November 1982: [SGH.003.5165]; response to Inspectorate dated 12 January 1983: [SGH.003.5059]

[61] [SGF.001.0234] at 0238

[62] i.e. Drs Brookes, McClelland, Mitchell and Urbaniak

[72] A subsequent report by Dow, Barr and Mitchell “Evaluation of the Ortho HCV antibody ELISA test system”, December 1989, stated that prison sessions had ceased in 1983. [SNF.001.1180] at 1188

[74] Annual Report of the SNBTS for the year to 31 March 1976 [SNB.010.3921]

[75] Annual Report of the SNBTS for the year to 31 March 1976. [SNB.010.3921]

[76] The other members were: Dr Rizza, Professor Blackburn, Dr Cleghorn, Dr Cumming, Dr Delamore, Dr Dormandy, Professor Douglas, Dr Grant, Professor Hardisty, Professor Ingram, W.J.Jenkins, Professor Kekwick, Dr d’A Maycock and Dr Wallace.

[77] Blood Separation and Plasma Fractionation: Harris Ed. 1990 page 19, based on the work of Pool & Shannon, 1965, New Eng
J Med 273:1433-1447.

[78] Cryoprecipitate was introduced in Scotland in 1970: [SNB.001.4923] at 4925

[79] Rizza & Spooner: Treatment of haemophilia and related disorders in Britain and Northern Ireland during 1976-80: 1983; BMJ 286:929 – 933. [LIT.001.0234]

[80] Watt J.G. Plasma Fractionation: Clinics in Haematology 1976.5.95. [LIT.001.1520]

[81] Biggs: Haemophilia Treatment in the United Kingdom from 1969 - 1974: 1977 British Journal of Haematology 35; 487 [LIT.001.0159]

[82] Foster PR and McIntosh RV: The development of hepatitis-safe Factor VIII Concentrate: 9 December 1999. [SNB.008.5220]

[83] Intl Dig Hlth Legis 1982; 33:17-20

[84] Foster PR and McIntosh RV: The development of hepatitis-safe Factor VIII Concentrate: 9 December 1999. [SNB.008.5220]

[85] Newman J, Johnson AJ, Karpatkin MH, and Puszkin S: Methods for the Production of Clinically Effective Intermediate- and High-Purity Factor VIII Concentrates: British Journal of Haematology, 1971. 21. 1. [SGF.001.1913]

[86] Cash and Spencely: Haemophilia A and the blood transfusion service; a Scottish study BMJ 18 September 1976 682. [LIT.001.0255]

[87] According to another source, cryoprecipitate was introduced in 1970. [SNB.001.4923] at 4925 This suggests a pattern of use that is at odds with the United Kingdom as a whole. For the United Kingdom as a whole, a graph of FVIII usage from 1969 to the end of 1985 appended to the report of the UK Regional Haemophilia Directors dated 4 February 1991 appears much more reliable. [SNB.001.5855] and [SNB.001.5870]

[88] However, it appears that continuous production was not commenced, trials were not completed and the product was not recorded as relevant to R & D at PFC until much later.

[90] The Preparation and Assay of a Christmas-Factor (Factor IX) concentrate and its Use in the Treatment of Two Patients: Biggs & Others Brit Jnl Haemat. 1961, 7, 349. [LIT.001.1332]

[91] The Preparation for Therapeutic Use of a Concentrate of Factor IX Containing also Factors II, VII and X. Brit Jnl Haemat 1967; 13; 568. [LIT.001.0084]

[92] National Survey of Haemophilia and Christmas Disease Patients in the United Kingdom. [LIT.001.0352]

[93] Haemophilia A Home Therapy in the United Kingdom 1975 –6: Jones and Others, British Medical Journal, 3 June 1978. [LIT.001.0258]

[94] Extracts in [DHF.003.0335]

[99] Dr Peter Foster: Plasma Fractionation in Scotland: Blood Letter Spring 2008.

[100] [SNB.002.1814] at 1816

[101] [SGF.001.0341] at 0342

[103] Chairman of SNBTS

[104] [SNF.001.0001] at 0006

[105] Cf Points of Clarification document in respect of a debate in the Scottish Parliament on 22 December 2005, prepared by an unnamed individual in the SNBTS on 1 February 2006. Central contracts for the purchase of commercial factor VIII were held by the Department of Health from 1972-1979. These were discontinued on 30 April 1979 and individual Health Authorities were advised to purchase commercial products locally thereafter. Detailed information on the use of commercial products was collected by UKHCDO and is held in [their] archive. [SNF.001.2449]

[106] HIV group litigation Statement of Claim, [SNF.001.4034]

[107] Cash and Spencely: Haemophilia A and the blood transfusion service; a Scottish study BMJ 18 September 1976 682. [LIT.001.0255]

[108]British Journal of Haematology, 1974, 27, 391: Dr Biggs & Others’ report.

[109] Cost or Management of Patients with Haemophilia: Cater and others: BMJ 21 August 1976, page 465.

[112] The full list of participants sets out the major players in the field (other than DHSS, SHHD and Northern Ireland government officials, who had not been invited) at this period. [SNB.001.4953]

[113] Mr Watt’s letter to Dr McIntyre of SHHD dated 29 October 1976: [SNB.001.4958]; and Dr Wallace’s report to SHHD dated 25 October 1976. [SNB.001.4960]

[115] Ibid

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