Memorandum submitted by The Biotechnology
and Biological Sciences Research Council (BBSRC) (R 5)
1. The evidence set out below addresses
the issue of the scale and focus of BBSRC's research into transmissible
spongiform encephalopathies (TSEs) with cross-references to relevant
paragraphs of the Phillips Report.
BACKGROUND
2. The Biotechnology and Biological Sciences
Research Council (BBSRC) was established by Royal Charter in April
1994. It is funded principally through the science budget of the
Office of Science and Technology (OST). The Council sponsors research
both in the university sector and its own institutes. The BBSRC
institutes also receive a proportion of their funding from the
Ministry of Agriculture, Fisheries and Food (MAFF) through commissioned
research and research support from other Government Departments,
the EU and industry.
The Council's mission is:
to promote and support high-quality
basic, strategic and applied research and related postgraduate
training relating to the understanding and exploitation of biological
systems;
to advance knowledge and technology,
and to provide trained scientists and engineers, which meet the
needs of users and beneficiaries (including the agriculture, bioprocessing,
chemical, food, health care, pharmaceutical and other biotechnological
related industries), thereby contributing to the economic competitiveness
of the United Kingdom and the quality of life; and
to provide advice, disseminate information,
and promote public understanding in the fields of biotechnology
and the biological sciences.
Funding Mechanisms
3. BBSRC funding for TSE research is through
two major routes:
the Biology of the Spongiform Encephalopathies
Programme (BSEP); and
core funding to the Institute for
Animal Health (IAH) which includes support for three aspects of
TSE research:
structure and function of prions;
TSEs in sheep especially the
pathogenesis of scrapie;
Biology of the Spongiform Encephalopathies Programme
4. BSEP was initiated in 1991 in response
to the Bovine Spongiform Encephalopathy (BSE) epidemic and built
on the existing expertise at the Institute for Animal Health (IAH)
mainly at the Neuropathogenesis Unit (NPU) in Edinburgh. The aim
of BSEP was to underpin the more strategic science funded by MAFF
and the Department of Health and complement the fundamental research
in relation to human health funded by the Medical Research Council
(MRC). An additional aim of BSEP was to expand the scientific
community in this strategically important area by attracting researchers
into the field from other scientific disciplines. To date there
have been four phases of the programme, the last in 1998. Each
phase invited applications in response to specific priorities.
Further details of how these research priorities were selected
are described in paragraph 9.
5. Applications to BBSRC for undertaking
research into TSEs are not confined to BSEP. BBSRC's policy is
to support TSE projects that are submitted as part of the Council's
normal grant awarding process.
6. BBSRC is developing a further call for
BSEP and has agreed an additional £8 million over three years
to cover phase 5 of the programme. It is anticipated that the
grants awarded will be announced in the autumn.
The Role of the Institute for Animal Health
7. IAH is a major UK centre for research
on diseases in farm animals. It also plays an important role in
education and training and its research underpins the development
of vaccines, diagnostic kits or reagents, genes, gene products
and vaccine vectors. The Institute comprises three sites at Compton,
Pirbright and the NPU. There are specialist facilities for TSE
research at the NPU and Compton.
8. In addition to the main TSE research
areas, a TSE Resource Centre was established at the Institute
in 1998 co-funded by BBSRC and MRC (reference: Phillips volume
2, paragraph 7.65). Its remit is to collect, store, characterise,
produce and distribute a range of reagents, from monoclonal antibodies
to teaching aids. The primary role of the Centre is to supply
a range of specialised research reagents needed for TSE research.
By providing an infrastructure to produce sufficient amounts of
quality reagents to meet the needs of users, not only has much
of the unfunded workload and cost currently placed on individual
laboratories been removed, but the reagents are available for
prompt distribution.
The Resource Centre provides reagents to both
national and international TSE researchers.
COMMISSIONING RESEARCH
Setting Research Priorities (reference: Phillips
volume 1, paragraphs 1289 and 1290)
9. Since the inception of BSEP, the BSEP
Working Party has advised BBSRC on TSE research priorities. Membership
of the Working Party comprises independent experts in the field
and invited observers from MAFF, Department of Health (DH), MRC
and, more recently, the Food Standards Agency (FSA). When selecting
members of the Working Party BBSRC has sought to maintain cross-membership
with the Spongiform Encephalopathy Advisory Committee (SEAC) and
the DH/MRC TSE Research Advisory Group. In reaching its recommendations
on research priorities the Working Party takes account of reports
and conclusions reached by SEAC, work supported by other funders,
nationally agreed priorities, guidance from the High Level Committee,
and progress being made by the current portfolio of BSEP projects.
Against this background, particular attention is paid to identifying
gaps in research and areas which could benefit from additional
research.
10. Current BBSRC priorities are:
to identify and characterise the
infectious agents of bovine spongiform encephalopathy and related
TSEs;
elucidation of the molecular basis
of strain variation in scrapie;
further development of transgenic
animal models for the investigation of the nature of the infectious
agent, transmission and the species barrier;
to understand the molecular basis
of pathogenesis of the TSE agents including those which affect
humans; and
to investigate the genetic control
of host animal susceptibility to TSEs.
Peer review (reference: Phillips volume 1, paragraph
1289, volume 2, paragraph 7.61)
11. In each phase of BSEP there has been
competition for the funding available and the programme has been
open to applications from all UK academic institutions, recognised
academic analogues, all Research Council institutes, Government
Research Establishments, agencies and UK not-for-profit organisations.
Applications undergo a rigorous assessment procedure involving
external peer review by experts in the field both in the UK and
abroad. The BSEP Working Party has the collective responsibility
for recommending to BBSRC which projects are worthy of support.
Research Community
12. Phillips comments (volume 1, paragraph
1132), "an attempt might have been made with advantage to
recruit expertise from the wider scientific community". This
was one of the original objectives of BSEP which has been maintained
in the subsequent phases of the programme. Achieving this objective
has not proved to be straightforward and although the number of
research groups and individual scientists working on TSEs has
increased substantially since 1990 the build-up has taken place
over a long period. The underlying factors thought to constrain
those who might think of breaking into the field include; the
complex nature of the subject, the need for expensive containment
facilities and the long incubation period of TSEs.
Research Co-ordination (reference: Phillips Report,
volume 1, paragraphs 1131, 1132, 1289; volume 2 paragraph 7.63)
13. The Phillips Report draws attention
to some areas of research that might have benefited from co-ordination
by a research supremo or committee. A number of mechanisms have
been put in place or augmented since 1996 to ensure the national
publicly-funded TSE programme is well co-ordinated. Details are
set out below.
TSE Funders Group and the High Level Committee
14. The TSE Research and Development Joint
Funders Co-ordination Group was set up in 1996. The present chairman
is Sir John Pattison. The membership comprises representatives
from the major public sector funding bodies; MAFF, BBSRC, MRC
and DH as well as The Wellcome Trust, Scottish Executive Rural
Affairs Department and Health and Safety Executive. The aims of
the Group are (i) to ensure that research programmes in the TSE
field address priority areas of national interest and (ii) to
form the basis of a coherent strategic approach between funding
bodies. BBSRC strongly supports these aims and considers that
this group has provided the basis to address the concerns raised
by the Phillips Report.
15. The first aim has been addressed through
enhanced networking between research scientists by means of regular
workshops (paragraphs 19 and 20 provide details) and a continuous
exchange of information of what each funder is supporting and
plans for further funding. On behalf of all the Funders a complete
listing of the UK research portfolio on TSE research is available
on the MRC web site (http://www.mrc.ac.uk/tse2c.htm).
16. In addition, the Funders have agreed
to make joint calls for new research proposals in key areas. A
joint call on the inactivation of the infectious agent was made
in 1999. Another call on diagnostic methods is to be announced
early in 2001.
17. In order to address the second of its
aims the Group has been responsible for developing research strategy
documents on the human health aspects of TSEs and the animal health
aspects of TSEs. These documents are currently under revision
and will be drawn together into a single strategy. This relates
to the comment made in the Phillips report, volume 2, paragraph
7.82 "to develop closer collaboration in the investigation
and management of human and animal disease".
18. As a further safeguard the Funders Group
reports to the High Level Committee on research into TSEs which
is chaired by the Cabinet Secretary. This Committee's terms of
reference are:
to ensure that a research strategy,
which fully addresses UK Government's policy needs in relation
to human and animal TSEs, is in place and agreed by all funders;
to ensure that mechanisms are in
place to implement the agreed research strategy and that progress
to implementation is taking place as quickly as possible;
to ensure that all relevant sources
of expertise are being called upon and the information is being
released to them as freely and quickly as possible;
to identify any barriers to progress
and make recommendations for overcoming them; and
to make regular reports to the Prime
Minister.
The Chief Executive of BBSRC is a member of
this Group.
Networking in the TSE Research Community
19. A condition of an award by BBSRC through
BSEP was that grantholders should attend an annual workshop the
aim of which was to report the latest results prior to publication.
This provided a mechanism for reviewing progress as well as an
opportunity for scientists to exchange ideas. The BSEP Working
Party was responsible for the workshop programme and representatives
from Government departments, SEAC and other funders were invited
to attend.
20. Following the emergence of variant Creutzfeldt-Jakob
Disease (vCJD), the importance of providing the opportunity for
researchers in the TSE as a whole, funded by all the relevant
funders, to report and discuss their results was acknowledged.
Since 1998, the size and scope of the workshop have been expanded
and it is now the intention to hold such workshops on a biennial
basis. The next such workshop is planned for 2002. This has increased
networking opportunities for the researchers and led to a more
collaborative approach to this intractable area of science (reference:
Phillips Report volume 2, paragraph 7.63 and volume 11 paragraph
4.638 onwards).
INTENSIVE FARMING
METHODS
21. With respect to the possible consequences
of farming practices, Phillips concludes (volume 1, executive
summary) that "BSE developed into an epidemic as a consequence
of an intensive farming practicethe recycling of animal
protein in ruminant feed". In this context the distinction
between intensive farming per se and an intensive farming
practice should be recognised. The use of meat and bonemeal (MBM)
as a feed supplement is not confined to the high-input, high-output
model of what has become known as intensive farming. It is common
practice among farmers using more extensively managed animal production
systems to supplement forage rations with concentrates which,
before the ban introduced in July 1988, could have included MBM
(Phillips Report, volume 12, paragraph 6,8).
22. As Phillips makes clear (volume 1, paragraphs
1142-1147) it is easy to understand why following 50 years of
recycling animal protein, the risk of a new virulent disease arising
as a result was not anticipated by industry or the regulators.
It is important to emphasise that the adaptation of living organisms
in response to environmental and other stimuli is an ongoing process.
Predicting how and when such adaptation might occur and the way
in which it might appear is, at best, a most uncertain science.
The emergence of E.coli O157 is a recent example. It is
by understanding the biology of known pathogenic organisms that
government can best respond to the emergence of new transmissible
diseases which might have possible consequences for human and
animal health.
30 January 2001
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