Memorandum by Baxter Healthcare Ltd.|
Baxter Healthcare has been conducting business
in the UK for over 40 years. We are a leading supplier of technologies,
products and services, related to the blood and circulatory system,
to the NHS and have been a pioneer in developing and bringing
to market many therapies to prevent and treat infection.
The company's blood therapies businesses produce
products that collect, separate, pathogen inactivate and store
blood, as well as therapeutic proteins derived from blood, their
genetically engineered equivalents and vaccines. Our renal products
cleanse the blood. Our intravenous products infuse drugs and other
solutions into the blood. Baxter's new Oncology division provides
chemotherapy drugs and cellular therapy products for the treatment
of cancer patients.
Baxter welcomes the Select Committee's Inquiry
into Fighting Infection and believes that it has a significant
contribution to make to the debate on fighting and preventing
infection given our interests in vaccination, blood transfusion
safety, and medication delivery. These are the areas that our
submission focuses on.
1. What are the main problems facing the
surveillance, treatment and prevention of human infectious disease
in the UK?
Blood transfusion safety
Blood transfusion is safer than it has ever
been however, the risk of contracting infections (viruses, bacteria
and parasites) from blood transfusion persists. Bacterial contamination
of blood components is the major reported cause of transfusion
transmitted infection and is a significant cause of death from
transfusion, (Serious Hazards Of Transfusion, SHOT Annual Report
Despite advances in surveillance procedures
through bodies such as SHOT, the extent of some transfusion-transmitted
infections is under-reported. This is particularly significant
in patients who are already vulnerable eg the immunocompromised
and where cause of infection or even death may be wrongly attributed
to the underlying disease. Another emerging blood-borne pathogen
could result in a major increase in the number of transfusion-transmitted
Blood screening is the practice used to deliver
safe blood however these tests have three important limitations.
The tests screen only for a limited
selection of known blood contaminants.
New viruses go undetected.
These practices are reactive only
and there is little protection against emerging pathogens.
According to the judgement in the case A and
Others v The National Blood Authority and Others, the public expects
100 per cent safety in relation to blood components used in transfusion.
In this sense all available technologies should be used to inactivate
harmful pathogens in order to deliver required safety.
Hospital Acquired Infection (HAI) and needlestick
injuries remain a major cause of infection and are an area of
infection prevention that has been given too low a priority by
Government. However they are well documented and significant in
both the primary and secondary care setting.
There are several known blood-borne pathogens
that can be transmitted by needlestick injuries including HIV,
hepatitis B and hepatitis C. The risk of infection after exposure
to infected blood varies according to the pathogen. The risk of
transmission after exposure to HIV infected blood is about 0.3
per cent whereas it is estimated to be up to 100 times greater
for hepatitis B virus (30 per cent) and could be as high as 10
per cent for hepatitis C virus.
2. Will these problems be adequately addressed
by the Government's recent infectious disease strategy Getting
Ahead of the Curve?
Blood transfusion safety
While the blood supply now is safer than it
has ever been, clearly the public demands even more stringent
safety. New technologies need to be proactively considered. Baxter
is developing a new pathogen inactivation technology that is proactive
and will have the ability to inactivate a broad range of blood-borne
viruses, bacteria and parasites (please see Appendix A for a description
of the technology). This technology is not yet applicable for
prions, as they do not contain nucleic acid and new ways are being
sought to develop this technology to tackle the prion threat.
It is likely that a test to detect prions will be developed and
this, in conjunction with pathogen inactivation technology will
provide the optimal solution.
4. Should the UK make greater use of vaccines
to combat infection and what problems exist for developing new,
more effective or safer vaccines?
Yes, the UK should make greater use of vaccines
to combat infection as they are an effective way of preventing
infectious diseases. The global eradication of smallpox, the eradication
of polio in Europe and the UK Meningitis C campaign are proof
of this. Vaccines exist against many of the pathogens but there
is still a need to develop new vaccines to protect against other
pathogens. Although vaccine medicine has developed considerably
in recent years, a number of challenges remain including:
Technological advances and enhanced
Regulatory Authority processes have increased both the time and
cost associated with developing and subsequently licensing a new
Safety concernsthis is and
should remain the most important factor when developing an effective
clinical issuesrelated to
the use of a vaccine once licensed. These include the uptake of
a vaccine in the target population. A key component in increasing
uptake is to ensure awareness in both the professional users and
the target population. This can be achieved through the support
provided to those receiving vaccines and the clinicians administering
5. Which infectious diseases pose the biggest
threats in the foreseeable future?
Emerging pathogens, new or previously unrecognized
infectious diseases are a very serious threat to public health.
In the last three decades, over 30 previously unknown infectious
diseases, for which there is no effective treatment, have become
prevalent and have been a major cause of illness and death.
HIV was not clinically recognised before the
early 1980s. Worldwide in 2001 alone, around three million people
died of AIDS and over 4 million adults were newly infected, as
were over 800,000 children less than 15 years old. In the UK,
the number of HIV cases is estimated to increase to 29,000 by
2003, an increase of over 40 per cent over the end of 1999.
In a recent publication for the Nuffield Trust
it is argued that the legal framework in England and Wales for
dealing with the control of communicable diseases is inadequate.
Influenza poses another serious public health
threat and the next pandemic is imminent. Other diseases that
pose serious threats include meningitis, which has a major impact
on the burden of serious childhood diseases.
6. What policy interventions would have the
greatest impact on preventing outbreaks of and damage caused by
infectious disease in the UK?
The Department of Health's Infectious Diseases
Strategy highlights the importance of vaccines in reducing the
burden of infectious diseases and Baxter welcomes this. The DoH
is committed to:
Extending the use of existing vaccines
to larger groups of people.
Continuing high coverage in childhood
immunisation programmes. It is particularly worrying that recent
figures released the Department of Health show that childhood
immunization rates are falling below their 1990s peaks.
Introducing new vaccines and investing
in R&DBaxter has a vaccine in development for Meningitis
B which would significantly impact on the burden of serious childhood
disease. We are also investing in vaccines to prevent streptococcal
infections and E Coli infections. Ongoing investment by industry
into new vaccines requires a stable economic and regulatory environment.
Producing more patient support materialBaxter
has assisted and will continue to work with the Department of
Health in producing materials to support and encourage the uptake
of vaccines by the public.
Additionally, it is important that the following
issues are considered and adequately addressed:
Vaccine availability (cf supply problems
with the TB vaccine).
A public health campaign raising
awareness of the importance of vaccination and ensuring a balanced
view of risk ratio etc.
Blood transfusion safety
Pathogen inactivation technology should be introduced
throughout the UK blood service following proper evaluation and
validation by the Department of Health. At present, pathogen inactivation
technology is the only technology to offer protection from unknown
and emerging infections, which pose a very serious threat to public
health. It has the potential to reduce the costs to society resulting
from the spread of disease through contaminated blood.
Blood safety is a political and emotive subject
that raises high expectations from the public, politicians and
the media. Pathogen inactivation can help assure the blood supply
is as close to risk free as currently possible.
As well as the cost in terms of human life,
the cost of follow-up testing, initial treatment with immunisation
and immunoglobulins following needlestick injury is very costly
(in the US it is estimated at $600-1,000 before lost time, litigation
and/or treatment of any infection resulting from the injury.
It has been estimated that 10 per cent of all
health professionals are injured annually by needlestick injuries
and one study has shown that in ITU 31 per cent of the infections
are nosocomial. Needle free intravenous access systems and moving
towards ready to use injectables wherever possible is a simple
way of reducing these risks.
The INTERCEPT Blood System is a prospective
technology that has been developed to enhance the safety of blood
component transfusions, with four key requirements providing the
basis for its development:
To enable a broad spectrum of pathogen
inactivation: (viruses, bacteria, protozoa and white blood cells).
Not affect the biological function
of platelets, plasma and red blood cells.
Be compatible with blood bank operations.
INTERCEPT technology for plateletsA Secondary
process designed to take place in the Blood Centre.