Volume 10: Economic Impact and International Trade
2. Impact on the public sector
Part 1: Research
MAFF expenditure
Department of Health
Research Councils
Scottish Office
Wellcome Trust
European Union
Summary of BSE/TSE-related research expenditure

2.5 Concerns about BSE led to research into the new disease and other transmissible spongiform encephalopathies (TSEs). ¹ These included scrapie in sheep and CJD in humans. We describe below the funding of research on BSE and other TSEs between 1 April 1986 and 20 March 1996 by UK Government Departments, the Research Councils, the EU and the Wellcome Trust.

MAFF expenditure

2.6 The Central Veterinary Laboratory (CVL) in Weybridge, Surrey, identified BSE in November 1986. From then on the CVL was responsible for many of the early epidemiological studies into BSE, and from 1987 had a dedicated BSE/TSE research programme in operation. The Consultative Committee on Research into Spongiform Encephalopathies (the Tyrrell Committee) was established in 1989. Its recommendations were published in 1990. ² Ministers decided that all projects designated as high priority by the Tyrrell Committee should be put in hand and that almost all these projects should be funded by MAFF. Additional funds were not allocated to MAFF for this purpose; instead, existing funds in MAFF's research budget had to be directed away from other areas to BSE research. ³

2.7 The establishment and expansion of the BSE/TSE research programme was set against a background of reductions in research spending resulting from overall downward pressure on public expenditure. ⁴ Table 2.1 shows total MAFF researchand development (R&D) expenditure ⁵ and the proportion of those funds designated for BSE/TSE research during 1986-96.

Table 2.1: MAFF expenditure on BSE/TSE research, 1986-96, at cash prices

2.8 MAFF's BSE/TSE research programme was mainly undertaken at the MAFF laboratories or at the Biotechnology and Biological Sciences Research Council's institutes, ⁶ although some of the work was carried out by external contractors. An account of MAFF's research and the projects undertaken can be found in vol. 2: Science.

2.9 The research carried out by MAFF fell into four main areas: epidemiology, diagnosis, transmission and pathogenesis. In the period between 1992/93 and 1995/96, these programmes cost £6.3 million, £4.4 million, £6.9 million and £5.7 million respectively - £23.3 million in all. ⁷

2.10 Some of the important projects within these programmes are described below:

1. Epidemiology. The epidemiology study began in June 1987 to gain basic descriptive epidemiological data, including breeding data, and to develop or eliminate aetiological hypotheses for the disease. It also aimed to monitor the incidence within herds and nationally. ⁸ The study included a survey of practices in rendering plants; an investigation of feed compounders in relation to their geographical location; an investigation of specific risk factors associated with the British Isles; a case control study of calf feeding practices; and an analysis of the offspring of bulls used for artificial insemination. From April 1992 to 1996, the epidemiology study cost £2,234,398; ⁹ no data are available for the cost of the project between June 1987 and April 1992. ¹⁰ Another important study was the investigation of the occurrence and incidence of maternal transmission, costing £336,874 from April 1992 to 1996 (no figures available prior to April 1992). ¹¹
2. Diagnosis. Experiments were designed firstly to study the clinical features of the disease with particular emphasis on methods of early diagnosis of BSE, and secondly to facilitate better and cheaper post-mortem diagnosis. The programme also aimed to develop methods for ante-mortem diagnosis. Major studies included the identification of BSE- and scrapie-affected animals by detection of a urinary metabolite (£294,000 ¹² between April 1992 and March 1995 - figures for April 1991 to April 1992 unavailable ¹³); and biochemical approaches to the differential diagnosis of BSE in the live animal (£187,000 ¹⁴ between November 1992 and March 1995).
3. Pathogenesis. Major studies included the identification of infectivity in cattle tissue (starting in April 1990, and costing £498,275 ¹⁵ between then and March 1996); the pathogenesis of experimental BSE in cattle (starting in April 1992 and costing £1,996,000 ¹⁶ by 1996); and the attack rate experiment, which started in April 1992 and had cost £745,229 ¹⁷ by 1996.
4. Transmission. Major studies included the investigation of the comparative efficiencies of the bioassay of BSE infectivity in cattle and mice, costing £722,663 ¹⁸ between April 1992, when the study started, and 1996. Embryo transfer studies began in October 1989, and cost £821,784 ¹⁹ between April 1992 and 1996 (figures since the start of the project are unavailable). ²⁰

Department of Health

2.11 The total R&D budget for the Department of Health rose from £15 million in 1988 to £27 million in 1996. ²¹ This budget was small compared with MAFF's R&D budget (see Table 2.1 above), because DH did not fund basic biomedical research relating to human health. This was the function of the Medical Research Council, which obtained funds for this purpose from the Science Vote, an approval of expenditure by Parliament. However, DH had its own 'Policy Research Programme' to identify and fund applied research to provide a scientific basis for policy formulation and evaluation. ²² It also funded the national Creutzfeldt-Jakob Disease Surveillance Unit in Edinburgh (see below).

2.12 Following the recommendations of the Tyrrell Committee in 1989 (see vol. 11: Scientists after Southwood), a CJD surveillance project was undertaken. The Committee's Report separated the project into two parts:

• surveillance of Creutzfeldt-Jakob Disease (CJD) cases; and
• monitoring of groups with high exposure to bovine tissues. ²³

The second part of the project was rated as low priority and, in the event, such monitoring was never undertaken, as it was considered that an analysis of the occupations of CJD cases would suffice to identify any correlation between exposure to bovine tissues and incidence of CJD. ²⁴

Creutzfeldt-Jakob Disease Surveillance Unit (CJDSU)

2.13 The CJDSU was formally established on 1 May 1990 to monitor the incidence and epidemiology of CJD cases, with a view to detecting any changes in the pattern of the disease, and to provide neuropathological validation of any clinical diagnosis. It was to build on the epidemiological work already carried out and originally funded by the Medical Research Council. ²⁵ Between 1992 and 1995 the Unit was also involved in investigating possible occupational links with CJD arising from the deaths of three dairy farmers. ²⁶

2.14 DH and the Scottish Office Department of Health jointly funded the Unit, with DH contributing approximately 90 per cent of the funding. ²⁷ The total level of DH funding for the CJDSU over the period 1990-96 was approximately £1.2 million. ²⁸

Funding of other BSE/CJD research

2.15 Over the period 1993 to April 1996 DH incurred expenditure on three discrete CJD-related research projects:

• Strain Characterisation of CJD Agent by Transmission to Mice. Studies began in 1994 at the Institute for Animal Health (IAH) and were based on six cases of CJD. Additional funding was provided from mid-1995 onwards for studies using tissue from young patients with CJD. Total funding (including these additional funds) for this project before April 1996 is estimated at £113,500. ²⁹
• Prion Diseases Group Molecular Genetic Studies. Funding was provided to St Mary's Hospital in London to carry out molecular genetic studies of the human prion protein. Total funding for this project before April 1996 is estimated as £280,400. ³⁰
• Scrapie Inactivation Study. Funding was provided to the IAH for research into the potential for iatrogenic transmission of CJD through instruments used in ophthalmic and neurosurgery. Total funding for this project before April 1996 is estimated as £340,000. ³¹

2.16 These projects all began before 1 April 1996, but in some cases were not completed by that date. Total expenditure until April 1996 on these three projects is estimated to be £733,900. ³²

Research Councils

2.17 The Research Councils are non-departmental public bodies, established under the Science and Technology Act 1965. They receive a grant from the Science Budget administered by the Office of Science and Technology (OST). The Research Councils that have had responsibility for BSE-related research are the Biotechnology and Biological Sciences Research Council (BBSRC), the Agricultural and Food Research Council (AFRC, a body which was succeeded by the BBSRC) and the Medical Research Council (MRC). ³³

Biotechnology and Biological Sciences Research Council (BBSRC)

2.18 The AFRC was succeeded by the BBSRC in 1994 and, for convenience, references in this volume to the BBSRC include its predecessor. This Research Council had the main responsibility for research related to BSE and scrapie. Total expenditure on TSE research over the period 1986-96 was almost £22 million. ³⁴ Figure 2.4 provides an annual breakdown of the funding levels. Funding grew significantly after 1989/90 and peaked in 1992/93.

Figure 2.4: BBSRC expenditure on TSE research, 1986-96, at cash prices

2.19 The BBSRC TSE research programme consisted of three distinct elements:

• research funded within the BBSRC core programme, which included 70 per cent of core funding of the Neuropathogenesis Unit (NPU) in Edinburgh; ³⁵
• research funded under the Biology of the Spongiform Encephalopathies Programme (BSEP); ³⁶ and
• research funded at the Institute for Animal Health (IAH) by other sponsors such as MAFF and the Medical Research Council (MRC). ³⁷

2.20 In 1989, because of widespread concerns about BSE and in order to implement recommendations by the Tyrrell Committee, the BBSRC was awarded additional Science Budget funds for research on TSEs. ³⁸ Part of this allocation was added to the core budget of the IAH in 1990/91. ³⁹

2.21 Further funds from this allocation were used to set up a new coordinated programme of research to investigate the Biology of the Spongiform Encephalopathies (BSEP I). The programme received £2 million in 1991/92 and £3.5 million in 1992/93. It also received funding from the MRC (see paragraph 2.26 below).

2.22 The aim of BSEP was to develop a fundamental understanding of the molecular and cellular biology of the TSEs. It was to build on the existing work already done by the NPU and to complement work funded by MAFF. Funds were allocated in two phases, from April 1991 and from January 1992, and were available over a three-year period. They were allocated on a competitive basis to higher education institutes and the former AFRC institutes. ⁴⁰

2.23 The BBSRC was awarded a further £1.3 million per annum over four years in 1994/95 to fund a second phase of projects (BSEP II). The funds were allocated on a similar competitive basis, available to higher education institutes and former AFRC institutes, and were available over the four-year period. ⁴¹

Medical Research Council (MRC)

2.24 The MRC was the main non-departmental public body through which biomedical research was funded. It was responsible for providing an independent source of expertise and advice on all aspects of research relevant to human health. ⁴² A concordat existed between DH and the MRC to ensure that the two bodies worked together effectively. ⁴³

2.25 The MRC had a focused portfolio of TSE/CJD research. This was principally carried out at the Neuropathogenesis Unit (NPU). The MRC provided 30 per cent of the NPU's core Research Council income. Its contribution amounted to around £300,000 in 1986/87 and rose to about £600,000 in 1994/95. ⁴⁴

2.26 The MRC also funded a small number of other TSE/CJD-related projects. For example, in 1994 a 'strategic supplement of £274,000' was awarded to the CJDSU over a three-year period for CJD-related transmission studies. The MRC also partly funded the first phase of BSEP, contributing £500,000 over a three-year period. ⁴⁵

2.27 Total expenditure over the period 1986-96 was approximately £5.6 million. The annual breakdown can be seen in Figure 2.5 below.

Figure 2.5: MRC expenditure on TSE/CJD research, 1986-96, at cash prices

Scottish Office

2.28 As noted above in paragraph 2.14, the Scottish Office provided funding during 1990-96 for the core costs of the CJD Surveillance Unit (CJDSU) based in Edinburgh. The Scottish Office contributions each year were determined after negotiations with the Department of Health in England. A pro rata contribution towards the core costs was not always sought by DH, which was responsible for the majority of funding. Over the period 1990-96 the Scottish Office provided £59,000. ⁴⁶

Wellcome Trust

2.29 The Wellcome Trust was founded in 1936, and the will of Sir Henry Wellcome required the Trust to support, primarily, research in the medical sciences. ⁴⁷ While it is not a public body, it is included here as a major funder of research carried out by public bodies, such as universities.

2.30 Between July 1990 and March 1996, the Trust granted about £3.1 million to various TSE-related research projects. ⁴⁸ These funds were mostly granted to universities. One of the Trust's main outlets for TSE research was the funding of Professor John Collinge and his group at the Imperial College School of Medicine at St Mary's Hospital in London. Approximately £2 million was provided for this purpose. ⁴⁹

European Union

2.31 All contributions by the European Union before 1996 were by way of grants that funded relevant research. During 1990-96 the EU spent about 4 million ECUs (£2.9 million) ⁵⁰ on TSE research. ⁵¹ The research programme on TSEs was organised at two levels:

• clinical research and surveillance of human TSEs; and
• basic biology of human and animal TSEs. ⁵²

2.32 Over the period 1990-91 the EU was involved in the organisation and financing of several BSE-related initiatives and workshops. These included two seminars and two diagnostic workshops. ⁵³

2.33 Research funding in the EU was allocated under 'Framework Programmes', which generally ran for four years. Under the Third Framework Programme (1990-94) four TSE-related projects were financed. These were:

• the surveillance of CJD in the EU;
• the study of the neuropathology, epidemiology and molecular genetics of human prion disease;
• the study of molecular neuropathogenesis and related neurodegenerative diseases; and
• the study of the characterisation of the BSE infectious agent. ⁵⁴

2.34 The UK was involved with some of these projects. For example, Dr (now Professor) Robert Will of the University of Edinburgh was the coordinator for the CJD surveillance project. ⁵⁵

2.35 The Fourth Framework Programme (1994-98) ensured research on prion diseases continued, and three additional projects were funded. One of these used animal models to address the issue of inter-species transmission and to assess the effectiveness of the species barrier in limiting the transmission of BSE to humans. ⁵⁶

Summary of BSE/TSE-related research expenditure

2.36 Figure 2.6 summarises the expenditure by various bodies on BSE/TSE-related research. ⁵⁷ As can be seen, MAFF accounted for 46 per cent of total research expenditure during 1986-96.

Figure 2.6: BSE-related research expenditure, 1986-96