1 Introduction
Background
1. The UK's first voluntary blood service was founded
by the British Red Cross in 1921, paving the way for the establishment
of a pioneering military service shortly before the outbreak of
war in 1939. Over the following years, blood transfusions played
an important role in the treatment of servicemen and civilians
alike and the benevolent spirit which motivated thousands to donate
blood during the war persisted after its conclusion, leading to
the creation of the UK Blood Transfusion Service in 1946.[1]
Today, approximately 2.2 million whole blood donations are made
in the UK each year and are screened, tested, processed and distributed
by one of the country's four Blood Services.[2]
2. Despite these altruistic foundations, the story
of blood transfusion in the UK is not unblemished. Throughout
the 1970s and the first half of the 1980s, many UK haemophiliacs
were treated with blood and blood products which carried the hepatitis
C virus; some 4,670 became infected as a result. Between 1983
and the early 1990s, contamination of the UK blood supply with
HIV led to a further 1,200 infections and it is estimated that
these incidents together have led to over 2,000 deaths.[3]
Since 1991, all UK blood donations have been tested for both HIV
and hepatitis C; however, the 2009 public inquiry investigating
these events stated that it was "dismayed" by the time
taken for Governmental and scientific agencies to "become
fully alive to the dangers" of these emerging infections.[4]
3. Today, we find ourselves facing another potential
threat to blood safety. Variant Creutzfeldt-Jakob Disease (vCJD)
is a rare neurodegenerative disease thought to be caused by an
unusual infectious agent known as a prion. First characterised
in 1996, vCJD is considered to be the human form of bovine spongiform
encephalopathy (BSE), another infectious prion disease believed
to have entered the human food chain in the 19070s or 1980s.[5]
Cases of vCJD are extremely rare: official statistics state that
229 people worldwide—177 in the UK, where the BSE crisis
primarily took place—have died of the disease since it was
first identified nearly 20 years ago.[6]
However, in October 2013, a paper published in the British
Medical Journal suggested that approximately 1 in 2,000 people
in the UK could be unknowingly carrying the prions responsible
for the disease, raising the possibility that hundreds of blood
donors could potentially be passing the infection on to others
through the blood supply.[7]
This gave us cause for concern and in November 2013 we held a
one-off evidence session examining the ongoing risk posed by vCJD.[8]
During this session, we heard evidence from leading experts suggesting
that the risk of secondary transmission of vCJD—through
both blood and contaminated surgical instruments—remained
"significant".[9]
We therefore decided to explore these issues further in an inquiry
focused on blood safety and the continuing public health risk
posed by vCJD.
Our inquiry
4. In December 2013, we issued a call for written
evidence addressing the following points:[10]
a) Are
UK policies governing who can donate blood and blood products,
tissues and organs sufficiently evidence-based? Is NHS Blood and
Transplant overly restrictive about who can donate, or should
greater precautions be taken to further reduce risk?
b) Is the
Government and its scientific advisory structure sufficiently
responsive to the threat posed by emerging diseases being transmitted
through blood and blood products, tissues and organs?
c) Has the
threat of ongoing transmission of vCJD through the blood and blood
product supply been adequately mitigated?
d) What are
the strengths and weaknesses of NHS Blood and Transplant's strategy,
"Taking Organ Transplantation to 2020"? What further
changes could be made to safely increase the supply of blood and
blood products, tissues and organs?
e) What lessons
could be learnt from the screening and donation practices of other
countries?
We received 55 written submissions and took oral
evidence from 27 witnesses, including:
· Individuals
personally affected by the issues under consideration, including
patient representatives and the mother of a victim of vCJD;
· Members of
relevant scientific advisory bodies, including UK Blood Services'
Joint Professional Advisory Committee, the Advisory Committee
on the Safety of Blood, Tissues and Organs and the Advisory Committee
on Dangerous Pathogens;
· Publicly- and
privately-funded researchers working in the fields of blood safety
and prion disease;
· Representatives
of the National CJD Research and Surveillance Unit;
· Representatives
of NHS Blood and Transplant (NHSBT) and Public Health England;
and
· The Government,
represented by Jane Ellison MP, Parliamentary Under-Secretary
of State for Public Health, Department of Health (hereafter "the
Minister") and Professor Dame Sally Davies, Chief Medical
Officer, Department of Health.
We would like to thank those who contributed to this
inquiry, with particular thanks to NHS Blood and Transplant for
hosting the Committee's visit to its Filton blood processing facility
in February 2014.
5. While focusing primarily on issues relating to
blood safety, we also took the opportunity during this inquiry
to consider the Government's new strategy for organ donation,
launched in July 2013.[11]
We heard evidence on this topic from the Government and NHSBT
and also held one dedicated evidence session during which we heard
from representatives of several medical charities.[12]
As a result of this work, in July 2014 we wrote to the Minister
urging her to maintain close scrutiny over the strategy's implementation
in the coming months.[13]
This report does not further detail this aspect of our inquiry.
6. In this report, we ask whether the Government
and UK Blood Services are doing enough to protect patients from
the risk of vCJD and other blood-borne infections. We begin in
chapter 2 by considering the types of infectious risks faced by
the UK blood supply and the controls currently in place to mitigate
these. In response to evidence received on the risk of surgical
transmission of CJD, we also extend this analysis beyond blood
to consider the risk posed by contaminated surgical instruments.
In chapter 3, we move from current risk reduction measures to
possible future ones and consider three emerging vCJD risk mitigation
technologies. We particularly examine the challenges that researchers
have faced in bringing these technologies to market and consider
the role of the scientific "gatekeepers" standing between
these new technologies and their adoption by the NHS. In chapter
4, we consider the current landscape for national CJD risk management
and surveillance and, finally, in chapter 5, we draw some conclusions
about the Government's attitude to blood safety and vCJD risk
mitigation.
1 NHS Blood and Transplant, History of blood transfusion,
blood.co.uk, accessed 12 June 2014; The Army Blood Transfusion Service,
British Medical Journal, Volume 1, Issue 4297, 15 May 1943, pp.610-11 Back
2
BTO30 para 2 [JPAC] Back
3
Independent Public Inquiry Report on NHS Supplied Contaminated
Blood and Blood Products, 'The Archer Inquiry', February 2009,
pp.5-6; HIV and Hepatitis C infection from contaminated blood
and blood products, Standard Note, SN/SC/5698, House of Commons
Library, July 2011 Back
4
Independent Public Inquiry Report on NHS Supplied Contaminated
Blood and Blood Products, 'The Archer Inquiry', February 2009,
p.104 Back
5
Parliamentary Office of Science and Technology, vCJD in the future,
POSTnote number 171, January 2002 Back
6
National CJD Research and Surveillance Unit, Creutzfeldt-Jakob Disease in the UK (by calendar year),
cjd.ed.ac.uk, accessed 30 June 2014 Back
7
O. Noel Gill et al, Prevalent abnormal prion protein in human appendixes after bovine spongiform encephalopathy epizootic: large scale survey,
British Medical Journal, Volume 349, Issue 7929, 2013. BMJ2013;347:f5675 Back
8
Science and Technology Committee, 'Inquiry: variant Creutzfeldt-Jakob Disease',
press release, 27 November 2013 Back
9
Oral evidence taken on 27 November 2013, HC (2013-14) 846, Q4
[Professor John Collinge] Back
10
Science and Technology Committee, MPs launch inquiry on blood, tissue and organ screening following vCJD fears,
press release, 3 December 2013 Back
11
NHS Blood and Transplant, Taking organ transplantation to 2020: a UK strategy,
July 2013 Back
12
Oral evidence taken on 28 April 2014, HC (2013-14) 990 Back
13
Correspondence from the Chair of the Science and Technology Committee to the Minister for Public Health,
9 July 2014, parliament.uk/science, accessed 14 July 2014. Back
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