Select Committee on Science and Technology Written Evidence

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 2000-01).

  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 infections.

  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.

Medication Delivery

  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 vaccine.

    —  Safety concerns—this is and should remain the most important factor when developing an effective vaccine.

    —  clinical issues—related 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 the product.

5.   Which infectious diseases pose the biggest threats in the foreseeable future?

Emerging pathogens

  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&D—Baxter 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 material—Baxter 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.

Medication Delivery

  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).

    —  Be a safe technology.

    —  Not affect the biological function of platelets, plasma and red blood cells.

    —  Be compatible with blood bank operations.

  INTERCEPT technology for platelets—A Secondary process designed to take place in the Blood Centre.

October 2002

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