Select Committee on Science and Technology Written Evidence

Memorandum by the Association of the British Pharmaceutical Industry (ABPI)

  The Association of the British Pharmaceutical Industry (forthwith referred to as the "Association" or "ABPI") represents the majority of the companies in the United Kingdom (UK) engaged in research, development, manufacturing and supply of prescription medicines. The ABPI brings together companies producing such medicines, whether branded or generic, many smaller organisations involved in pharmaceutical and biopharmaceutical research and development (R&D), and those with an interest in the pharmaceutical industry in the UK. ABPI member companies manufacture and supply more than 80 per cent of the medicines prescribed through the National Health Service (NHS) and are major exporters to countries all over the world.


  In preparing its response to questions put forward by the House of Lords' Science and Technology Sub-Committee on Fighting Infection, the ABPI has drawn upon evidence provided by member companies. The submission also makes use of the Anti-infectives Research Mission to the USA 9-13 August 1999 report produced by the Department of Trade and Industry and the ABPI, the ABPI's written and oral evidence submitted to the House of Lords' Select Committee on Science and Technology for the Resistance to Antibiotics and Other Antimicrobial Agents Session (1997-98, 7th Report), and the European Federation of Pharmaceutical Industries and Associations' position paper (1999) on Containment of Antibacterial Resistance.

  The ABPI strongly endorses the appropriate use of anti-infective agents in fighting infection to benefit patients. The ABPI supports the publication, Getting Ahead of the Curve (GATC), in addressing the problem of infection. We support the House of Lords in taking steps aimed at further strengthening the UK's anti-infectives initiatives and are pleased to have been invited to produce written evidence. Our aim in submitting evidence is to put forward the pharmaceutical industry's view on how to tackle infectious diseases in the UK most effectively, and to identify policies which improve surveillance, diagnostics, prevention and treatment of infectious diseases.

  The UK benefits from medicines, in particular those discovered and developed in the UK, not only for the health benefits enjoyed by patient populations, but also in economic terms. The ABPI believes that the most important contribution the pharmaceutical industry can make in the fight against infectious diseases is to continue its research efforts. Research areas covered by UK-based pharmaceutical companies are identified in the ABPI's A to Z of British Medicines Research (2002)[1]. The ABPI welcomed the Pharmaceutical Industry Competitiveness Task Force (PICTF) process and recommends that the Government continue to take firm action to create a supportive environment for pharmaceutical and biotechnology companies in the UK.


  There needs to be significant investment in a surveillance system within the NHS with links across regional and national boundaries. Without a co-ordinated and effective surveillance system, reliable information will not be available to enable the development of appropriate treatment or prevention strategies. With appropriate organisational structures, diagnostic aids and information systems in place, incentives would serve to ensure the effective use of a surveillance system.

  Whilst the NHS can take overall responsibility for surveillance, it cannot undertake prevention and treatment by itself. The Government can most effectively continue the fight against infection with a multifaceted approach embracing the health services, industry and academia to ensure that surveillance information is used to inform research programmes.

  Modern prescribing practices and systems need to be strengthened to enable UK general practitioners (GPs) to implement prescribing guidelines and prescribe novel medicines. Guidelines on appropriate prescribing of anti-microbials should be coupled with procedures for correct usage. Ensuring take-up of new medicines should serve to promote a positive environment for the research and development into new vaccines and medicines. Without treatments, the UK would be increasingly unable to fight infection. Without prevention strategies, treatment would be overwhelmed and surveillance would be irrelevant.

1.   What are the main problems facing the surveillance, treatment and prevention of human infectious disease in the UK?

  1.  Historically, one of the main problems has been a deficiency in Government expenditure on, and a lack of co-ordination of, surveillance and reporting systems. The Public Health Laboratory Service (PHLS) laboratories provide microbiology services in the UK. With the ongoing reorganisation of the NHS, there is a possibility that their operation and co-ordination will be disrupted. It is considered that any such disturbance should be minimised to ensure continuity of service. The prevention and treatment of infectious diseases will be compromised if standardised diagnostic procedures, and information technology (IT) systems to facilitate coordination and communication of reliable, real-time data are not developed. Without improvements in the implementation of any new proposed surveillance procedures, expenditure on diagnostic technologies and IT systems will be wasteful. Without co-ordinated cross-boundary surveillance initiatives, regional surveillance systems will be undermined.

  2.  In the UK, GPs are conservative in their prescribing of novel therapeutics. Whether the underuse of novel testing and treatment options is due to lack of availability, lack of awareness of what is available, or budget constraints undermining the concept of "Appropriate Prescribing", this issue needs to be addressed.

  3.  The UK policy climate does not provide a sufficiently supportive environment for the development of anti-infectives by companies. There is not enough Government support for collaboration between the NHS, industry and research institutes to highlight priorities for R&D.

  4.  Mixed results have followed previous Government initiatives to impact prescribing behaviour and reduce resistance to antibiotics. Within the UK, there is a conflict between the adoption of advanced antibiotics with lower resistance levels and other desirable attributes, and the economic constraints of prescribing within the NHS. Use of inappropriate antibiotics wastes time and money, extends the period of illness and may exacerbate the emergence of resistance, endangering other patients. There is inconsistency in the auditing amongst NHS Trusts and Primary Care Trusts.

  5.  Current UK policy initiatives do not serve to encourage investment in vaccine development programmes by the pharmaceutical industry.

2.   Will these problems be adequately addressed by the Government's recent infectious disease strategy, Getting Ahead of the Curve?

  6.  GATC recognises the weaknesses within the structure of the NHS in enabling a co-ordinated surveillance system. The ABPI supports the formation of a National Infection Control and Health Protection Agency to oversee a national comprehensive surveillance strategy, including the effective co-ordination of the network of PHLS laboratories.

  7.  Variation exists in the use of IT to support reporting and surveillance systems. GATC draws attention to one of the roles of the proposed National Infection Control and Health Protection Agency in developing information systems to close surveillance gaps. We welcome this and discuss the IT issue further under Question Three.

  8.  GATC recognises the importance of greater alignment of national and European surveillance. However, GATC deals primarily with surveillance systems in England. An efficient surveillance system will require a surveillance system which links across boundaries, for example, Scotland, Wales, Ireland and continental Europe.

  9.  Microbiologists should be enabled to generate reliable, standardised resistance data supporting patients' treatment and contributing to resistance surveillance needs, including global standardised susceptibility sensitivity tests for whether a bacterium is sensitive or resistant to an antibiotic. GATC recognises the need for a fully accredited diagnostic and reference microbiology service underpinning a strong system of surveillance and introduction of standards for diagnosis and profiling of micro-organisms. The ABPI strongly supports a mandatory system of evidence-based standard operating procedures in diagnostic laboratories, together with a mandatory accreditation system. Further diagnostics issues are discussed under Question Three.

  10.  The current statutory reporting system is inadequate and variably adhered to. To ensure high quality surveillance, the ABPI recommends the implementation of incentive systems to ensure that surveillance systems are used effectively. This is not addressed in GATC.

  11.  The ABPI supports the sharing of surveillance information in an appropriate and timely manner between health services, industry and academia. This will serve to inform research programmes on the demographics and epidemiology of disease, and avoid potential delays in the development of new products for the prevention and treatment of infectious diseases.

  12.  We recommend that the NHS support the use of novel therapeutics and technologies. The ABPI supports the establishment of best practice in prescription guidelines, together with electronic prescribing capability and support systems for implementation, for example recommendations put forward through National Service Frameworks and the National Institute for Clinical Excellence. This issue is not addressed in GATC. In addition to patient benefits, we consider that higher levels of prescribing of clinically effective novel medicines will have a positive impact on the launch of new anti-microbials in the UK.

  13.  GATC recognises the need for R&D in order to generate new therapeutics. The ABPI is of the opinion that there is a lack of emphasis by the Government on fundamental research in the treatment and prevention of emerging and re-emerging diseases. New diseases are continuously arising and infectious disease organisms mutating. More bacterial research needs to concentrate on pathogens of importance to the UK, and additional research should be dedicated to viruses, mycology and parasitology. We do not consider that this issue is sufficiently addressed in GATC. In supporting the co-ordination of NHS R&D programmes with those of research councils, charities and pharmaceutical companies, the ABPI recommends the development of a National Infectious Diseases Research Network based on the recently established London model.

  14.  Physicians should be encouraged to prescribe antibiotics at an appropriate dosage and for an appropriate length of time. There should be increased public awareness around the importance of completing the full course of prescribed antibiotics. As noted in GATC, regular training and education should be provided to healthcare professionals and patients on the proper use of antibiotics.

  15.  The ABPI supports the effective use of information on the profiles of infectious diseases associated with the shifting demographics in the UK population, for example, the growing number of elderly people and immigrants, in order that vaccination programmes be efficiently targeted.

3.   Is the UK benefiting from advances in surveillance and diagnostic technologies; if not, what are the obstacles to its doing so?

  16.  The ABPI considers that the UK is not sufficiently benefiting from advances in surveillance technologies. We consider it highly important that a sophisticated national real time integrated electronic disease surveillance system be established to deliver high quality information to improve the nation's ability to identify and track outbreaks and emerging infectious diseases, antibiotic resistance, and potential bioterrorism attacks. A surveillance system should be able to transfer appropriate public health, laboratory, and clinical data efficiently and securely over the Internet. Information, organised in databases, linked with mathematical models should be able to be analysed quickly and accurately. We recommend significant cooperation between clinicians, diagnostic laboratories, other relevant NHS departments, industry and academia in ensuring that IT systems are user-friendly and co-ordinated.

  17.  The ABPI considers that the UK is not sufficiently benefiting from advances in diagnostic technologies. Diagnostics underpin therapy and surveillance of resistance. Investment in standardised, state of the art technologies is needed to bring the UK back up to standard. The ABPI recognises that an impediment to the use of advanced diagnostic technologies is the cost of accommodating new technology. We propose evidence-based recommendations on appropriate novel diagnostic tests, and justification to support additional costs of testing, where appropriate.

4.   Should the UK make greater use of vaccines to combat infection and what problems exist for developing new, more effective or safer vaccines?

  18.  The best way to deal with infectious diseases is to prevent them. Vaccines and their use as part of national immunisation programmes continue to rank among the most important contributions to public health in the UK. The ABPI considers that the Government should make greater use of vaccines to combat infection, where appropriate. We support the UK Vaccine Industry Group in its recommendation that by promoting greater access to licensed vaccines, planning the introduction of new vaccines to target previously unmanageable infectious diseases such as meningitis B and rotavirus, and through more effective dialogue with stakeholders, significantly more can be achieved as part of an overall programme to fight infectious disease.

  19.  The science of vaccines is highly complex, and clinical development may be lengthy and risky. The policy environment in the UK which serves to determine pricing may result in poor economics for vaccine R&D by UK-based pharmaceutical companies. Clear demonstration of health economic arguments will be critical in driving vaccine development by pharmaceutical companies, as well as uptake by healthcare practitioners. Companies will need to weigh the rewards of more directed therapies against the drawbacks of reduced indications. As long as vaccines prove uneconomical for pharmaceutical companies, they will be more focused on treatments for infectious diseases, rather than prevention (DTI/ABPI, 1999).

  20.  The ABPI commends GATC's recommendation for a programme of new vaccine development, though clarification is sought regarding source of funds for R&D and responsibility for undertaking vaccine R&D.

  21.  We recommend that the Government recognise the possibility that despite the development of new, more effective or safer vaccines, negative media coverage may undermine immunisation programmes. Such media coverage may also frustrate attempts to undertake clinical trials, especially as for many vaccines trials have to be done in children. We consider that vaccination programmes must be in the context of robust education of, and communication to, the general public on the role of vaccination in the overall public interest to avoid the difficulties arising from adverse media campaigns on the use of the MMR (mumps, measles and rubella) vaccine.

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

  The ABPI considers the following infectious diseases to constitute the biggest threats:

Infectious Disease Information Costs TreatableVaccine Available
Methicillin Resistant Staphylo- coccus aureus (MRSA) Hospital acquired infections, particularly due to organisms where resistance is rapidly emerging to commonly used agents (eg MRSA) are increasing in prevalence. Thus therapeutic options are diminishing thereby increasing costs of management. High (Due to hospitalisation, delay in hospital discharge and morbidity) Yes (MRSA is resistant to many antibiotics, but a few can still successfully cure infections) No
(Multi-resistant) TuberculosisTB is responsible for the greatest number of deaths. Antibiotic resistance affects a small, but growing, group. Multi-resistant tuberculosis is an important disease as communicability is high. High. (Due to treatment costs)Yes Yes
Human Immuno- deficiency
Virus (HIV)/ Acquired Immune Deficiency Syndrome (AIDS)
Chronic disease(Due to direct and indirect costs). YesIn development
STDs (excluding
Increased infertility, especially with increase in chlamydia, increase in ectopic pregnancy, increase in cervical cancer High (If results in infertility and reduced population size) YesIn development
Gastric and duodenal
ulcers and gastric cancer due to Helicobacter pylori
H pylori is the most important factor in the aetiology of uncomplicated peptic ulcers. Evidence suggests that 73 per cent of gastric cancers are attributable to H pylori and 65 per cent of peptic ulcer deaths. It has been estimated that 1:35 men and 1:60 women will die from a complication of H pylori infection (Moayyedi and Axon, 1998)[2]. High (Due to treatment costs, morbidity and mortality). YesIn development
InfluenzaWell covered for the elderly but insufficient funding for <65s target group High. (Due to treatment costs, morbidity and mortality) YesYes
Infections in immuno- compromised populations Due to an increase in the susceptible patient population. VariableVariableDepends on the disease
New and emerging infectionsDue to uncertainty about natural history and diagnostic tests, long-term consequences and possible treatment modalities (eg new variant Creutzfeld Jacob Disease, nvCJD). VariableVariableDepends on the disease
Imported infectionsDue to lack of local knowledge YesDepends on the disease

  22.  A distinction may be made between threats to morbidity, mortality and financial and economic costs of infectious disease. To determine which infectious diseases pose the biggest threats, we recommend that attention be given to cost of illness and cost-effectiveness studies[3], and where information is lacking, further studies be undertaken.

6.   What policy interventions would have the greatest impact on preventing outbreaks of, and damage caused by, infectious disease in the UK?

  23.  In this issue, it is important to acknowledge the roles played by academic and government research institutions, and pharmaceutical and biotechnology companies in discovering and developing those anti-microbials which have served to improve outcomes for patients and reduce the costs of disease.

  24.  We consider that with the backing of the Government, the UK has the opportunity to take a lead internationally in anti-infectives research, in particular, where clear preventative strategies are already evident, such as in the case of HIV, AIDS, MRSA, multidrug resistant tuberculosis, genital chlamydia, and food borne infections.

  25.  The ABPI recommends unequivocal Government support for UK-based biotechnology and pharmaceutical companies. Policies which support commercial R&D activities and dispersal of products to patient populations should serve to contribute to prevention. The ABPI recommends that the Government assist companies through providing additional marketing exclusivity for pharmaceutical companies, for example, for medicines developed in children upon Government request. We urge the Government to continue its support for proposals to improve the efficiency of clinical research laid out in the PICTF report. These include a reduction in licensing times and bureaucracy for animal testing and clinical development, and co-ordinated action to deter animal rights activists and to educate the public in the importance of animal testing.

  26.  The ABPI supports policies which promote a partnership approach between companies and healthcare professionals to provide an appropriate environment for the development of new medicines, vaccines, diagnostics, and drug delivery tools.

  27.  We urge the Government to encourage those involved in anti-infectives research including academia, industry and health services, to play a greater role in emphasising to the public the importance of biotechnology and new life-saving medicines.

  28.  We continue to impress on the Government the importance of ensuring improvements in education in science, engineering and technology. This will require significantly increased funding of, and emphasis on, scientific study on infectious diseases in academic and research centres of excellence, and related infrastructure.

  29.  The ABPI welcomes the outcome of further legislation in Section 60 of the Health and Social Care Act enabling the continuation of surveillance of non-statutory communicable diseases.


1.   What are the main problems facing the surveillance, treatment and prevention of human infectious disease in the UK?


  1.  Inadequate accreditation systems for laboratories, hospitals and community care facilities.

  2.  A shift in healthcare provision from hospitals to the community means that more healthcare related infections are within the public arena, such as nursing and residential homes. This poses a greater challenge for traditional surveillance methods.

  3.  Insufficient communication with the public in terms of communication at times of crisis. Also, there is an irregular system of reporting by individual physicians and microbiology laboratories.


  4.  The several hundreds of marketed antibiotic formulations represent only nine separate drug types with only five distinct modes of action. Evolution or acquisition of resistance to even one class of antibiotics significantly reduces the choice of treatments available to the physician (DTI/ABPI, 1999).

  5.  We note that previous reports on resistance to antibiotics and other anti-microbial agents produced by the House of Lords' Select Committee on Science and Technology have drawn attention to the growing problem of infectious diseases and antibiotic resistance. We consider that there has been a mixed outcome as a result of these reports' recommendations. For example, whilst there has been a reduction in the use of antibiotics overall, there has been a growth in expenditure on antibiotics in some disease areas, for example, lower respiratory tract infection (LRTI), due to the rise in use of parental antibiotics.

  6.  The ABPI questions whether the level of NHS expenditure on anti-infective treatment is targeted properly. Treatment decisions may not be made on the basis of an infection being established. Cost pressures may cause treatments to be inappropriately applied to patients, which may induce greater sickness. For instance, from 1997 to 2000 hospital admissions for LRTI increased by 68 per cent; this coincided with a decline in community prescribing for LRTI by 26 per cent. The campaign to reduce inappropriate antibiotic prescribing for upper respiratory tract infection may have produced important consequences for the management of LRTI in terms of outcomes and resource use.


  7.  The shift in healthcare provision to the community will result in a greater challenge for establishing preventative measures for infectious diseases. One solution to improve the situation would be the development of a community infection nursing service.

  8.  There is an absence of good evidence concerning what is cost-effective in terms of different prevention programmes and reducing the emergence of antimicrobial resistance (Wilton et al., 2002)[4].

  9.  Lack of guidelines on hygiene, which are central to reducing the spread of disease.

  10.  Using the wrong antibiotic, sub-optimal dosage and duration of treatment along with reduced patient compliance can lead to the selection of bacterial populations with reduced susceptibility and thus trigger the development of bacterial resistance. This is recognized in GATC.

  11.  Overuse of antibiotics in agriculture is also considered to be a significant contributor to antibiotic resistance.

2.   Will these problems be adequately addressed by the government's recent infectious disease strategy, "Getting Ahead of the Curve?"


  12.  The ABPI considers that there is a need to effectively move the existing predominant diagnostic role of microbiology laboratories to a wider public health function, in effect to become specialists in public health for communities served rather than routine diagnostic processing centres.

  13.  The ABPI has concerns regarding how public health surveillance of food and water, for example, will fit in the overall picture.

  14.  The ABPI recommends that therapeutic and economic impacts of continuous versus intermittent surveillance be assessed to assist in the development of meaningful health policy decisions (EFPIA, 1999)[5].

  15.  The ABPI recommends improvements in surveillance methods and procedures, such as those suggested by the ABPI (see Appendix One for a list of recommendations on surveillance procedures), and in GATC.

  16.  GATC addresses the issue of mandatory accreditation of laboratories. The ABPI considers it important for all healthcare facilities to be accredited including hospitals and community care settings.

  17.  A shift in healthcare provision from hospitals to the community poses a greater challenge for traditional surveillance methods. The ABPI recommends that the Government should outline its strategy for surveillance in community settings.

  18.  There is an irregular system of reporting by individual physicians and microbiology laboratories. The issues around communication of changes in surveillance and reporting systems to health care professionals and the wider public are not adequately dealt with in GATC. The Association recommends that the Government outlines its policy in this regard. Similarly, the ABPI recommends that the Government outlines its policy on communication at times of crisis.

  19.  In considering policies which would serve to prevent outbreaks of and damage caused by infectious disease in the UK, the ABPI recommends a simple, universal, robust reporting and surveillance system with:

    —  Clear guidelines for inclusion/exclusion of infections.

    —  Rapid identification of clusters/outbreaks of infections and provision of appropriate alerts.

    —  The ability to provide data on antimicrobial susceptibility at international, national and local level in response to enquiries.

    —  The ability to monitor outcomes on both a short term and long term basis.


  20.  We welcome the Government instructions that NICE recommendations are taken up by the Trusts, especially as there have been recommendations by NICE and further appraisals are underway.

  21.  In order to treat patients, it is important to have available the appropriate therapeutics. Currently, although there is investment in R&D by pharmaceutical companies, there is a lack of treatment alternatives. This needs to be tackled through greater investment in R&D, on for example new antibiotics with characteristics that facilitate patient compliance, for example, simple dosage regimen and reduced side effects. GATC recognizes the need for R&D in order to generate new therapeutics. There appears to be little emphasis attached by UK Public Health policy on the fundamental role of research in the treatment and prevention of emerging and re-emerging infectious disease. The ABPI recommends that the House of Lords urge the Government to make explicit, at an appropriate point in time, its R&D investment strategy and methodologies and justifications in the decision-making process policy.

  22.  Bacterial research needs to concentrate on pathogens of importance to the UK, ie Gram positive, including MRSA, Tuberculosis, vancomycin (or glycopeptide)-resistant enterococci, and also Gram negative bacteria such as Pseudomonas aeruginosa. Alternatives to antimicrobials, for example, use of bacteriophages, also need to be developed.

  23.  The majority of research is on bacteria (see Appendix Two for recommended research on the organism's response to antimicrobials). More research is also needed on viruses, mycology and parasitology. There is a need for more work on STDs.

  24.  Whilst closer collaboration between therapeutics companies and research institutes should serve to highlight priorities for R&D, there are difficulties associated with encouraging UK centres to collaborate with pharmaceutical companies in anti-infectives research due to cost issues, particularly large overhead costs imposed by some university and academic institutions.


  25.  More needs to be done to address social inequalities which fuel the spread of infection. There is a disproportionate burden which some infections place on certain social groups. For example, tuberculosis disproportionately affects certain minority ethnic groups, and HIV affects Black Africans and gay men more than other groups in society. Ways need to be found to ensure that prevention messages and health services are accessible to different social groups. Unless this is accomplished, there is the risk that the health gap will widen. Immunisation programmes should be implemented where appropriate.

  26.  In assessing cost-effective approaches to reducing antibiotic resistance, Wilton et al. (2002) recommend further investigation:

    —  validating intermediate or surrogate outcome measures to enable better use to be made of the literature on intermediate outcomes;

    —  development and evaluation of "macro" strategies; and

    —  empirical and methodological research concerning the economic evaluation of interventions.

  27.  As recommended in GATC, isolation and hand hygiene are central to reducing the spread of disease. We recommend that such a programme targets high-risk areas: intensive care and surgical units, in particular. Community-wide public health strategies, such as home hygiene, must also be given a much higher profile. (See Appendix Three.) Also, community-based institutions need to be more aware of cross-infection. This would be aided by the development of a community-infection nursing service.

  28.  As part of local health improvement programmes, local antibiotics have been more readily formulated as part of clinical governance.

  29.  An audit approach for managing antibiotic prescribing to reduce the need for antimicrobials is recommended for further investigation.

  30.  Antibiotics should be used only when indicated in individual infected animals for a targeted pathogen and prescribed by a veterinarian. The use of certain drugs that have important uses in humans should be restricted in animals.

3.   Is the UK benefiting from advances in surveillance and diagnostic technologies; if not, what are the obstacles to its doing so?

  The ABPI considers that the UK is not sufficiently benefiting from advances in surveillance and diagnostic technologies, as discussed below.


  31.  Despite several initiatives, no broad based real time systems are available in the UK to deliver high quality local surveillance information. This is in part due to:

    —  failure to standardise IT reporting and surveillance systems;

    —  costs of introducing new IT systems to support reporting;

    —  excessive complexity of existing reporting systems;

    —  lack of incentives for reporting; and

    —  lack of understanding of purpose and importance of technology developments and where and how they could improve existing systems.

  32.  Strengthening IT in the NHS is addressed in GATC and the DH's 2002 report Delivering 21st Century IT support for the NHS: National Strategic Programme. We recommend significant cooperation between NHS departments in ensuring that IT systems are well coordinated.


  33.  Diagnostics have the potential to underpin therapy and surveillance of resistance:

    —  Isolation of infecting organisms from clinical samples.

    —  Determination of antibiotic susceptibility test results through in vitro testing.

    —  Guidance of the correct choice of antibiotic.

    —  Provision of more accurate data for the purposes of hospital prescribing policy, control of prevention, surveillance and epidemiology.

  34.  There have been several improvements in rapid and accurate diagnostic tools for anti-infectives including molecular diagnostic technologies, and near patient testing. Novel diagnostic technology products, eg biochips, biosensors, and high-density deoxyribonucleic acid (DNA) arrays represent more rapid and accurate tools. Novel approaches using ultramodern molecular techniques such as DNA microarray analysis can identify genes whose expression is up or down regulated under different environmental stresses and whose products can then be targeted. Genetic tests for bacterial resistance give faster, more accurate microbiology, ensuring that the patient gets the right antibiotic sooner. Sequencing whole pathogen genomes such as Salmonella spp. has already reaped rewards with the production of a Polymerase Chain Reaction-based system for detecting multi-drug resistance in S. typhi. Rapid bedside tests will distinguish patients with bacterial infections who need antibiotics from those with viruses who do not (DTI/ABPI, 1999).

  35.  Further improvements in molecular diagnostic methods are needed for:

    —  detection of resistance markers;

    —  development and evaluation of rapid detection techniques;

    —  rapid screening methods for patient isolation; and

    —  rapid typing methods for the epidemiology and control of resistant organisms.

  36.  Several recommendations are made in GATC:

    —  a strong system of surveillance should be supported by fully accredited diagnostic and reference microbiology services; and

    —  proper diagnostic and treatment facilities should be made available for people with infections (including isolation facilities for those with highly infectious diseases).

  37.  To benefit from novel diagnostic tools, the Government needs to be proactive in two areas: funding research and increasing budgets.

  38.  Pressure on budgets has led to a reduction in the quality of UK microbiology with bacteria incompletely identified and with few antibiotics tested. UK laboratories cannot afford the costs of precise identification and high quality sensitivity testing. Consequently, the quality and quantity of microbiological testing in the UK is behind that of the US and most of Europe. GATC highlights the significant gaps which exist in specialist and reference diagnostic microbiological testing; as well as the variety of management arrangements for microbiology laboratories and lack of standard diagnostic criteria in their operations. Investment in standardized, state of the art technologies which underpin detection and surveillance of resistance is needed to bring the UK back up to standard.

  39.  Antimicrobial resistance is continually evolving. To keep up with this pace of change in resistance requires new diagnostic tests. R&D activity is expensive and mainly funded by companies. To encourage investment in diagnostic technologies, the ABPI recommends that the Government outline its strategy for: using diagnostics in combating infectious diseases and the resistance problem; funding diagnostics R&D; and coordinating its diagnostic R&D activity with that of the pharmaceutical companies.

4.   Should the UK make greater use of vaccines to combat infection and what problems exist for developing new, more effective or safer vaccines?

  40.  The previously immense burden of morbidity and mortality associated with "common" childhood diseases such as diphtheria and pertussis is now rare. However, as acknowledged in GATC more can be done. Taking preventative measures when managing public health has benefits for the individual, the population as a whole, and for the NHS through effective use of health care resources.

  41.  The ABPI supports GATC in recognizing the need for a carefully managed relationship with the research community and the vaccine industry. We suggest that this relationship encompasses the medical profession, Wellcome Trust, Government Research Councils, patients, pharmaceutical industry, researchers, health authorities, and the general public.

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

  42.  In considering which diseases pose the biggest threat, the ABPI suggests that the Government take note of whether screening and prevention measures are currently available which are not widely used. There are cost of illness and cost-effectiveness studies available which provide information on economic and clinical costs and benefits associated with different screening, prevention and treatment measures. For example, a conservative crude estimate suggests that the cost of dyspepsia in the UK is £525 million each year. Any eradication programme for H pylori would be expensive but would be partially offset by over £50 million each year saved (Moayyedi and Axon, 1998).

  43.  Insufficient collaboration between industry and academic/healthcare institutions in establishing national priorities for infectious disease management and prevention.

6.   What policy interventions would have the greatest impact on preventing outbreaks of and damage caused by infectious disease in the UK?

  44.  There is a huge medical need for anti-infectives at global level. However, commercial organizations will inevitably focus finite R&D resources on therapeutic areas where they can reasonably expect to generate a return on their investment. Equally, commercial organizations will look at the market situation in individual countries to assess whether or not to embark upon the approval process to launch the product at a local level. The ABPI considers that policies which support commercial institutions in R&D activities and product launch will help to address the issue of prevention of outbreaks and damage caused by infectious disease in the UK.

  45.  Biotechnology, which is undertaken in both pharmaceutical and biotechnology companies, continues to offer new approaches to the discovery, design and production of drugs, vaccines, diagnostics, and drug delivery tools (for example, liposomal formulations) making it possible to:

    —  anticipate and prevent infectious disease rather than just react to symptoms;

    —  treat and cure more infectious diseases with more precise and effective medicines with fewer side effects;

    —  eliminate contamination risks for infectious pathogens by avoiding the use of human and animal sources for raw material; and

    —  apply novel control methods once the mechanisms by which antibiotic resistance genes emerge and spread are understood.

  46.  There is a need for highly coordinated research on the epidemiology and genetics of antibiotic resistance with regards to the impact of usage of antibiotics in human and veterinary medicine (Hawkey and Thomson,1999)[6].

  47.  Further basic research in anti-infectives in academia need to be stimulated. Academics in the UK, as compared to the US, are not encouraged to be as enthusiastic about the application of their research to the treatment and prevention of infectious diseases.

  48.  In the UK grant support for research in anti-infectives and antibiotic resistance is diverse and needs greater coordination and strategic direction (DTI/ABPI, 1999). All avenues should be explored to encourage effective multi-stream funding of research in academia (industry research councils, medical charities and the NHS) and barriers to such collaborations removed (DTI/ABPI, 1999).

  49.  Academic scientists in UK university and governmental laboratories are neither as well informed about pharmaceutical research in anti-infectives nor as receptive to collaborating with the large pharmaceutical companies, as their US counterparts. Increased collaboration between industry and academia in this field needs to be encouraged to help establish national priorities for infectious disease management and prevention. Policies need to encourage collaboration with and investment by industry.

  50.  The ABPI considers the Government should establish mechanisms which encourage the commercialization of innovation within academic and healthcare institutions.

  51.  UK Public Health policy places insufficient emphasis on the fundamental role of research in the prevention of emerging and re-emerging infectious disease (DTI/ABPI, 1999). Funding ongoing research into the mechanisms and spread of resistance needs to be a priority for the Government.

  52.  Another key step in the development of biopharmaceutical products is testing their efficacy and safety in clinical trials. The efficiency and effectiveness of this process is constrained through bureaucracy in initiating the trials, cost, access to patients and number and quality of investigators.

  53.  A key stumbling block for companies in the UK is the bureaucracy around getting clinical trials started. A survey of 19 countries showed that only the UK and Hungary have four regulatory and ethical approval steps compared with only two for the majority (11/19) of the countries. Under the EU clinical trials directive introduced in April 2001 and to be implemented by member states by 2004, a 60 day timeline is given for regulatory activity. As a result of PICTF, the UK Government has agreed not to wait until 2004 but is already taking steps to implement some of the requirements, such as parallel review of research protocols. The goal is that the UK will be an attractive place for clinical research in Europe. In the UK there has been an agreement that all regulatory processes and protocols reviewed would be done in parallel within 60 days by: 1) Medicines Control Agency, 2) MRECs (Multi Research Ethics Committees), 3) LRECs (Local Research Ethics Committees) and 4) local hospital R&D committees. As part of the PICTF agreement, the ABPI is benchmarking clinical research start-up times and patient recruitment. Early results are encouraging in that 60 per cent of multi-centred trials are able to begin 60 days after the ethics committee application and more than 80 per cent of local studies. This compares with less than 40 per cent before the PICTF process began. It is recommended that the Government continue to support the 60 day review procedure, as well as review the need for LREC involvement in multi-centre research.

  54.  Companies require large numbers of subjects for clinical trials but recruitment in the UK is low. Thirty per cent of sites in the UK fail to recruit a single patient compared with 10 per cent in the US. Currently recruitment is being benchmarked by the industry. The NHS R&D Directorate and ABPI are developing a clinical trial agreement that should enhance recruitment to industry organised trials in the UK.

  55.  The UK is one of the most expensive countries in the world for clinical research, and over the past decade growth in costs have risen at a higher rate relative to continental European countries (Continental Europe:UK=60-70:100). The ABPI welcomes the recently announced DH's review of its guidance on the relationship between prices charged and the cost of studies with the intention of greater transparency and consistency in pricing.

  56.  The ABPI considers that more and better trained investigators are needed for clinical research. The ABPI is working with the Research Ethics Committees to develop a joint training programme for companies in improving Ethics Committees' applications. We recommend that the Council of Heads of Medical Schools introduce good clinical research practice into the undergraduate curriculum.

  57.  The ABPI considers that taking part in clinical research is of benefit to participants.

  58.  The ABPI and NHS R&D Directorate launched a partnership agreement for collaborative clinical research in England and Wales in 2002.


  In the surveillance of resistant organisms, the ABPI recommends undertaking the following research:

    —  Molecular epidemiology of resistant isolates.

    —  Current levels of resistance in both the hospital and community settings.

    —  Reasons for the current increase in antibiotic resistance, eg if related to level of prescribing.

    —  Dynamics of the spread of resistance.

    —  Public health impact from rise in resistance.

    —  Relation between rise in resistance and particular patient groups.

    —  Impact of resistance levels following a reduction in use of specific antibiotics.

    —  Proportion of the population who consults the GP with specified syndromes.

    —  Reasons GPs send samples.

    —  Surveillance of near-patients testing data on organisms and resistance.

    —  Propensity for emergence of resistance.

    —  Impact of antibacterials on clinical outcomes.

    —  Impacts of controlling antibacterial usage.

    —  Effect of antibacterial usage on the carriage rates of resistant organisms in the hospital and community.

    —  Clinical outcome in infections with resistant versus sensitive organisms.

  Routinely generated susceptibility data research needs:

    —  Informed population denominator.

    —  Standardization of laboratory methods.

    —  Link resistance and prescribing data.

    —  Reservoirs of resistance in the normal flora and environment.

    —  Linkage to specific disease syndromes.

    —  Focus on problem environments, such as day care and nursing homes.

    —  Link outcome data, ie response to treatment.


  Recommended research on the organism's response to antimicrobials:

    —  Impact of anti-microbial resistance on microbiological outcomes.

    —  Population biology, including the effect of resistance on fitness.

    —  Stress responses.

    —  Basic cellular processes in bacterial model systems.

    —  Host interactions.

    —  Molecular genetic basis of resistance mechanisms.

    —  Detection of novel resistance genes.

    —  Evolutionary biology, eg origin of resistance.

    —  Mechanisms for the emergence of resistance.

    —  Molecular genetic basis of biosynthesis.

    —  Efflux mechanisms, particularly environmental cues.

    —  Regulation of anti-microbial resistance.

    —  Structure-function analysis.

    —  Proteomics.

    —  Cell-to-cell communication.

    —  Mechanism of resistance transfer and subsequent maintenance of resistance (including plasmid replication).


  In monitoring infection control, the following issues should be addressed:

    —  Determine the relationship between antibiotic prescribing, hospital hygiene and performance in infection control.

    —  Show how to improve control of infection with antibiotic-resistant organisms association with invasive devices.

    —  Evidence-based practice of even basic measures such as hand washing, barrier nursing, patient isolation, etc.

    —  Mode of action of disinfectants.

    —  Mechanisms and genetics of resistance to disinfectants.

    —  Association of disinfectants with antibiotic resistance (shared targets, etc).

    —  Comparison of disinfectants.

    —  Impact of handwashing on the transmission of resistant organisms.

    —  Improve effectiveness and adherence of handwashing protocols.

    —  Environmental effects of hospital hygiene.

    —  Effects of inadequate ward cleaning and poor hospital environmental hygiene on the emergence and spread of antibiotic resistance.

    —  Validated evidence for the impact of staffing levels, patient movement, patient isolation, hospital design etc on the spread of antibiotic resistance.

1   ABPI. An A to Z of British Medicines Research, 2002. Third Edition. May 2002. Back

2   Moayyedi P, Axon A T R. Is there a rationale for eradication of Helicobacter pylori? Cost-benefit: the case for Helicobacter pylori infection. British Medical Bulletin. 1998. 54(1):243-250. Back

3   Refer to Health Economics Evaluation Database, Office of Health Economics, October 2002. Back

4   Wilton P, Smith R, Coast J, Millar M. Strategies to contain the emergence of antimicrobial resistance: a systematic review of effectiveness and cost-effectiveness. J Health Serv Res Policy. Vol 7 No 2, April 2002, pp.111-117. Back

5   European Federation of Pharmaceutical Industries and Associations. Position Paper: Containment of Antibacterial Resistance. November 1999. Back

6   Hawkey P M and Thomson C J. The Pharmaceutical Journal, Vol 263, October 2, 1999. (Letter). Back

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