Select Committee on Science and Technology Minutes of Evidence

Memorandum by the Public Health Laboratory Service (PHLS)


1. The PHLS welcomes this inquiry and the opportunity for a critical look at this important area of PHLS core business.

2. Many of the problems with the surveillance of infectious diseases were well described in the recent strategy from CMO England. Some additional areas are highlighted in this paper.

3. Areas where surveillance needs to modernise include the targeted selection of subjects and samples from settings typical of where infection is found, the use of new testing technologies, the intelligent use of information technology, the linking of laboratory reports with clinical data and outcomes, and real engagement with those at the front line.

4. Some of the threats and current obstacles to improved surveillance are described. The PHLS has reservations over the hasty organisational changes proposed in Getting Ahead of the Curve, and is unclear how these will assist progress in surveillance. It is difficult to see the changes will manage to be resource-neutral. Other key points in this evidence are summarised on the final page.

5. Infectious diseases are an ever-present threat. Staff from the current PHLS will need to continue with their important personal contribution, whatever their individual employing organisation from April 2003.


1. The Public Health Laboratory Service (PHLS) operates across England and Wales and provides some services under contract in Scotland and Northern Ireland. For over 50 years it has provided a range of expert laboratory-based microbiological services and also epidemiological work related to infectious diseases. The remit of this Inquiry falls within the core business of the PHLS.

2. The PHLS welcomes this inquiry and the opportunity to contribute to the evidence before the committee. With the proposed organisational changes in England and in Wales this year and next, it is timely to look again at the systems for the surveillance of infectious disease. The recent strategy from the CMO England for combating infectious disease, Getting Ahead of the Curve, provides the overall context within England. Whilst the PHLS Board has made clear its concern with the proposals in that strategy for the over-hasty dispersal of current PHLS resources1, it has also indicated the PHLS is prepared to cooperate fully with a Ministerial determination on the issue2. That being so, the evidence that follows here attempts to look forward critically but constructively to help improve the nation's ability to Fight Infection".

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

3. Although there are many definitions of surveillance, the shortest and most telling is that surveillance is the delivery of information for action". This not only has the merit of brevity, but also emphasises that surveillance should not be merely the process of amassing large volumes of data. Surveillance also entails the analysis and interpretation of data so as to create meaningful information. The information that is so created must be of a form that can inform purposeful action, which in the case of communicable disease control often needs to be of a rapid and reactive nature, though it will also include action taken as part of a longer-term policy implementation. Finally, surveillance must deliver information to those who are required to take the action, be that a direct clinical or public health intervention, setting of a strategy or the further development of a policy. In the absence of timely, valid and accessible information on communicable disease epidemiology, control of the spread of disease within the population, and development of policy for communicable disease control and prevention would be no more effective than would the development and practice of economic policy and financial business without suitable economic data.

4. Enormous advances in communicable disease control were achieved in the 19th and 20th centuries through improvements in sanitation, hygiene and nutrition, and latterly through the use of vaccines and antimicrobial agents, although resistance to these is an ever present and increasing threat. The development of new vaccines probably represents the greatest potential for future control and prevention of communicable disease, but for many infections of public health importance it is unlikely that effective vaccines will be developed in the next 10-20 years. For example, no vaccines exist for HIV, hepatitis C and malaria, and better ones are needed for tuberculosis. In the meantime, control continues to depend on the identification and control of threats in food, water and the environment, the promotion of disease avoidance and early identification and treatment of human disease.

5. The new challenges for communicable disease surveillance and control include the need to be able to identify and respond to new or re-emerging infections, particularly those resulting from increasing international travel, the effects of modern health care and animal husbandry (not least on the emergence of antimicrobial resistance), the every present risk of transfer of infection from other species (such as avian influenza), and the threat of bio-terrorism. In addition, there is now a growing recognition that infectious diseases can give rise to chronic disease sequelae, such as cancers (eg hepatitis B and human papillomavirius), peptic ulceration (helicobacter pylori) and infertility (eg genital chlamydial infection). Any cost-benefit analysis for intervention strategies is incomplete without considering the chronic effects of acute infection. Thus even within the confines of communicable disease, surveillance has evolved from primarily being used for collation of reported outbreaks and simple description of trends, (once mostly of gastrointestinal and respiratory conditions), to a broader portfolio of activities. In the 21st century communicable disease surveillance encompasses the analysis of data on sexual and other behaviours, uptake of vaccines, cancers, and a widening range of demographic and clinical descriptors. This will inform public health and clinical policy and practice on conditions and issues that include chronic infection, vaccine safety, screening, performance monitoring, healthcare associated infection, travel health, antimicrobial resistance and deliberate release.

6. Additional challenges for surveillance are posed by changes in clinical practice and the infrastructure of the health services within which it is delivered. With the increasing delegation of policy implementation and responsibility for delivery of clinical and public health services to the local level (Primary Care Trusts and Hospital Trusts), many surveillance systems will need to be retooled to provide information that can inform action at this local level. Furthermore, the growing awareness of inequalities between socio-economic groups in the burden of communicable disease morbidity, and the development of government policies on reducing such inequalities, requires that surveillance systems can deliver information on socio-economic variations in communicable disease incidence. These changes are unlikely to be resource-neutral.

7. Surveillance must respond to the expectations of professionals and the public, raised by advances in technology, particularly information technology and the pressures to continuously improve standards of healthcare delivery ie clinical governance. It should meet the need to link human disease data with data from outside the health service, and achieve this within constraints imposed by new legislation and interpretation of older legislation on confidentiality, data protection and human rights. It is timely to review the evidence base for how and why surveillance is now being undertaken, with a view to making its inputs and outputs most relevant to clinical practice and public health performance. This kind of development requires greater collaboration and more shared ownership of surveillance systems by clinicians and public health practitioners than has hitherto been the case as well as greater awareness of the importance and use of surveillance data by decision-makers and the public. For this it will be necessary to address current concerns over the uses of patient data within the health service and also to harness advances in information technology to facilitate the capture, analysis and dissemination of the large volumes of data that will sometimes be necessary. A major function of surveillance has always been to detect the unexpected, but since the events of 11 September 2001 and the bio-terrorist attacks that followed, it is clear that effective health protection should include surveillance to detect what might previously have been unthinkable to most people in the NHS. This poses significant challenges, with the need to extend surveillance beyond the realms of clinical certainty and even beyond the current reach of the health service.

8. Most recently, Getting Ahead of the Curve has made explicit calls for the development of more integrated surveillance systems that draw on human, environmental and veterinary data. Current surveillance systems for acute gastrointestinal infection in England and Wales have achieved many notable public health successes in recent years, such as the early detection of national and international outbreaks and the recognition of emerging problems such as Escherichia coli O157, through the close integration of local regional and national microbiological and epidemiological expertise. The broadening of these systems through the integration of surveillance data from environmental and veterinary sources should add to their strengths. It will be important, however, that a set of principles for the sharing and analysis of combined data sets be agreed between the relevant agencies, to ensure that data are not over-interpreted and that the current strengths and partnerships in surveillance are built upon. It should also be recognised that not all gastrointestinal infections are foodborne and that surveillance is key in defining transmission routes for different pathogens. Surveillance of gastrointestinal infection is funded through the Department of Health, although the results of foodborne disease surveillance are of greater direct benefit to the Food Standards Agency since the formation of the latter. Demands for surveillance information from the Food Standards Agency, which has a legitimate interest in and need for the data, are unlikely to be matched with increased funding from the Department of Health to meet those increasing demands.

9. The increased ease of access to data has required new data protection legislation and led to both public and professional concerns about the possible abuse of personal data. These concerns have been particularly focussed on uses of patient data for purposes other than direct clinical care, suggesting that a distinction needs to be made between population-based surveillance and data management for the purposes of action directed at the individual. Whether the placement of CsCDC outside the NHS will also give rise to concerns about the exchange of information between clinicians working in the NHS and CsCDC working in the HPA has yet to be determined. It may be some time before the HPA is as closely integrated with the NHS as was the PHLS, both in professional and public perception and in reality.

10. An issue for further debate relates to the local structures for identification and management of infectious disease. Investment here is uneven3 and responsibilities unclear. In the new system, partnerships will be needed between the health protection specialists (health protection units and laboratories of the HPA), the public health generalists (PCTs in public health networks), clinicians and microbiology generalists (in PCTs and acute trusts) and local authorities. Whilst service level agreements (SLAs) and memoranda of understanding (MOU) will help define those relationships, there is no substitute for genuine partnership based on mutual respect and understanding. With new management structures this will take time to develop and could be inhibited by tensions relating to accountability or funding. At present, for example, the source of funding is unclear for the identification and typing of pathogens for public health rather than clinical purposes, other than for specialised work done by the HPA through its own laboratories or by commissioning.

11. Increased and sustained investment for surveillance of infections within primary care and community settings will be needed. There is a particular need to combine clinical and demographic data with laboratory results. Such surveillance is able to reveal the epidemiological pattern of infection at a population level.

12. Among the many issues raised in Getting Ahead of the Curve was the urgent need to update infectious disease legislation. For example, in spite of the increasing problem of tuberculosis, it is illegal to require treatment for those with active disease, unlike in the United States.

13. A further area of concern is the high rates of exposure to and ease of transmission of infections in special groups, such as men having sex with men, and in special settings, including prisons and detention centres. The reform needed to reduce transmission rates may need to be fundamental, eg around attitudes to casual sex in the young, or potentially counterproductive to other government policies, eg around the handling and dispersal of asylum seekers.

14. One of the priority areas for action outlined within Getting Ahead of the Curve is antimicrobial resistance. Around half of the bacteria currently tested for resistance are from hospital patients yet most antibiotic prescribing is in the community. This means the vast majority of community infections deemed (rightly or wrongly) to require antibiotic have no antibiotic susceptibility done. Those that do have such tests done, recorded and included in passive surveillance are likely to have recalcitrant infections, maybe recalcitrant owing to resistance, or are from patients with complex problems. These form a biased sample. Similar problems of bias apply to most other areas of passive surveillance.

15. By international standards, laboratory testing might also be sub-optimal. For antibiotic resistance testing, for example, isolates are often not identified to species level, except from bacteraemias; isolates are tested with too few antibiotics; and those antibiotics they are tested with are not consistent in different places, making it difficult to pool data. There is also a need for surveillance of the molecular basis of resistance, requiring detailed investigation by a reference, specialist or academic laboratory.

16. The right way to keep abreast of antibiotic resistance would be sentinel surveys of resistance in community pathogens with all patients presenting with a particular set of symptoms being sampled, not the present eclectic sub-set. For isolates passing through diagnostic laboratories, there would need to be identification of species and the routine testing with a wider range of antibiotics, including core sets in all laboratories. Were such data collected for surveillance purposes, computer expert systems could be used to identify anomalous resistance patterns, so identifying isolates that required reference laboratory and molecular investigation. It is unclear how such systems could develop and be funded under the HPA, though it is noted antimicrobial resistance is a priority area in Getting Ahead of the Curve.

17. Although this PHLS evidence has concentrated on the diagnosis and surveillance of infectious disease, this is not to downplay issues relating to treatment and vaccination policy. In some areas, there are significant weaknesses in the evidence base to support clinical decision-making related to infections, especially in primary care. The difficulties in promulgating guidelines and changing practice even when evidence is available also need to be recognised.

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

18. The PHLS and its Board has welcomed this strategy and the prominence it has given to the need for a concerted effort to deal with infectious disease. In the months since the strategy was announced, most effort has been focussed on the establishment of the Health Protection Agency (HPA) and the transfer of many of the current PHLS laboratories to the NHS. The PHLS has expressed concern about the implementation processes1, 2, but has no issue with the remaining policies within Getting Ahead of the Curve, even though some, like the creation of a Microbiology Inspector remain inadequately defined. The overall implementation project plan for Getting Ahead of the Curve has not been shared with the PHLS, but the PHLS stands ready to give what expert assistance it can, for example to contribute to plans to improve surveillance, including exploring new ways of encouraging and facilitating reporting, such as direct from general practice and the public.

19. Whilst welcoming the strategy, the PHLS would have wished to have been more closely involved in its generation. The PHLS believes that had recommended practices in policy-making been followed4, we could have avoided some of the difficulties currently being experienced in the smooth introduction of the changes desired by Government. With PHLS assistance, a more coherent policy might have been generated.

20. Issues of concern from the PHLS include the pace of change, especially the disruption of the integrated PHLS network for microbiology and epidemiology before alternatives are ready. Risks to business continuity over the change period are being identified and mitigating action put in hand, but time and internal capacity may prove too tight. There are staff retention issues during this period, especially in already short supply areas, eg staff handling food, water and environmental (FWE) samples, and those at risk of redundancy like group managers. This is in spite of the short-term guarantees within the change management protocol agreed with the Trade Unions. Also, there are risks from disillusionment of PHLS staff who feel their public health role has been undervalued or unrecognised in the decision to transfer them to individual NHS trusts. This is a serious threat to morale and to their future commitment to deliver the public health activities that are required.

21. Concerns over the future for surveillance were considered by the PHLS Research and Scientific Strategy Committee5 to be top of the league" in terms of risks of the proposed changes. Whilst some believe routine laboratory—based surveillance might be little affected, especially that which already comes from NHS hospitals, others believe the lack of explicit funding for public health work will mean this could well fall off. There is real and general concern about the capacity to deliver enhanced surveillance or to mount an acute response.

22. It appears the laboratory support for public health in the Regions will be dependent on the HPA regional labs, the former PHLs following transfer to NHS management, and the rest of the NHS labs which will be expected to recognise their PH responsibilities. There will need to be the cooperation of host" Trusts in which HPA regional labs will be located, but this has been compromised by three statements6: that early consideration should be given to handing management of clinical microbiology back to the Trust; that part of their laboratory funding will be completely removed and redistributed to PCTs as part of general allocations in 2004; and that their funding for public health work will be guaranteed at its present level only until March 2005. The cooperation of host" Trusts in which former PHLs are located has also been compromised by the last two of these DH statements. There appear to be no plans as yet for providing any material incentive for NHS laboratories to rise to the public health challenge, and a fear that in local tussles about funding, money will be diverted from public health purposes.

23. Whilst Getting Ahead of the Curve recognised the important synergy between routine diagnostic and public health microbiology, the current proposals appear to introduce and increase the separation. This is a retrograde step. National level public health work, whether microbiological or epidemiological, benefits from personal knowledge and experience of activity at the routine diagnostic of field sharp-end, and reflection with practitioners on a daily basis. R&D activity likewise is more likely to reflect the important issues that affect practice and recognise the potential biases in data if done side by side with routine work. The PHLS has had a wide spectrum of activity related to communicable diseases within one organisation: it remains to be seen how the very real potential for silos to be created will be counteracted in the new structures.

24. The need for national co-ordination of certain outbreak investigations must not be forgotten in the implementation of the Health Protection Agency. This and the need to bring national expert support to bear on some local outbreaks were two of the reasons for the creation of CDSC. For example, the nationwide distribution of food means that national level investigations are needed and the investigation of legionella outbreaks often require specialist input. Relationships between Divisions in the Health Protection Agency and across regions of the NHS will require recognition of national jurisdiction on occasion.

25. The PHLS is especially well placed to contribute to the public health response to communicable disease in countries with more limited resources as a result of its expertise in communicable disease surveillance, epidemiology and microbiology. A wide range of collaborative projects is currently carried out with other countries by the staff within the PHLS. These are largely conducted on an ad hoc basis, often carried out by staff in their own time or grant funded. The potential contribution, however, is greater than this and, in particular, could include the ability to respond to communicable disease emergencies around the world at the request of the WHO as well as the opportunity to train health professionals from other countries in the UK. The inability of the PHLS to respond to requests of this sort, other than exceptionally, is the result of a lack of surge capacity and the opportunity costs to the PHLS resulting from the deployment of experienced staff, which would impair the ability of the PHLS to fulfil its domestic responsibilities.

26. The WHO has made clear its wish to be able to call on the expertise of the PHLS. Following a presentation by WHO to the PHLS Board in 2001, the development of international work within the PHLS was supported with the rider that this had to be balanced against already stretched resources. While the potential benefit to other countries has rightly been emphasised, the benefit to the UK of the involvement of the PHLS in such work should also be stressed. Such work provides staff with experience of exotic infections in the field or laboratory, infections which could be at risk of importation. While the former benefit is potentially of interest to DfID, the latter is of more direct interest to the DH. Joint support from these two Departments, based on agreement at an appropriately high level, is needed to unlock the potential for a more substantial and responsive PHLS/HPA contribution in this area.

27. The areas in which the PHLS could make a significant contribution include:

— To make people available to provide emergency assistance in response to outbreaks.

— To support capacity-strengthening in specific countries by seconding PHLS staff on a temporary basis.

— To enable people with expertise in specific aspects of microbiology and/or epidemiology to provide support to specific countries on a consultancy basis.

— To use our expertise and facilities in this country to train people from other countries.

— To target our support efforts to specific countries and specific infections (eg lassa fever) where the UK need to strengthen its capacity coincides with that of the target country.

28. A large number of other concerns have been raised within the PHLS. The proposals for stripping out and repackaging R&D funding appear to have little merit, but do have the potential to disrupt current good work, including that on peer reviewed grants for external agencies. Efficiencies in bulk purchasing may be lost together with the PHLS network, adding to the disbelief that the changes can be resource neutral. There are many important synergies between the regional and national parts of the PHLS which many fear are being jeopardised as the constituent parts are placed in different organisations. Reference and specialist microbiology needs to link in with routine public health microbiology, and both with routine clinical diagnostic work. The advantages may be being lost from the handling in the same laboratory of human specimens and food, water and environmental samples, maybe relating to the same outbreak. In the PHLS there has been collaboration between epidemiology and public health microbiology at all levels, and it is unclear how this will be maintained.

29. Having a skilled and well-motivated workforce will be key to delivering the aspirations of Getting Ahead of the Curve. It is feared the central role of the PHLS in supporting training and high standards may be lost to those joining the NHS. As CsCDC change into local health protection consultants, fewer of them may have a background in medical microbiology. All this means extra effort will be needed to ensure that there is mutual understanding across the public health and microbiology disciplines, with common training modules for both doctors and scientists/non-medical specialists. With time and the right enthusiasm, there might even be merging of elements of the public health microbiology" and health protection specialist" career paths. To achieve this, the HPA might be expected to need a creative and forward-looking training programme for its staff. However, it seems all the current PHLS medical microbiology training posts are proposed for transfer to numerous bodies in the NHS, with damage to the maintenance of expertise and succession planning specially need by the PHLS/HPA. Currently, the expected role of the HPA in managing training in other disciplines is unclear.

30. The medical microbiologist and clinical epidemiologist could also benefit from increased joint training and understanding with veterinary colleagues, and with infectious disease physicians. As increased investment elsewhere in the NHS increases demands for clinicians, it will be especially important to look critically at skill mix in health protection. This means a joint HPA-NHS plan to exploit to the full the abilities of all the players in the multidisciplinary team, removing any artificial barriers to personal career progress.

31. In spite of many reservations, PHLS staff at all levels are striving to introduce the changes required by Government, whilst seeking to mitigate the risks. The PHLS is now committed to working with DH on delivering the changes, in the light of the Secretary of State having determined the more limited role for the PHLS in future.

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

32. Advances in information technology in recent years have offered new opportunities but have also raised the expectations of those who provide as well as those who process and receive information. It is now possible to collate, analyse and disseminate data in much larger volumes and at far greater speed than ever before. These same developments in information technology have also provided the opportunity of bringing together large volumes of data from disparate sources for analysis and record linkage, with the prospect of gaining greater insight into disease patterns and associations. An example is the examination of suggested associations between MMR vaccination and a series of clinical syndromes. The electronic patient record and electronic health record projects have the potential of making it possible to access a greater breadth and depth of patient data for surveillance purposes. For these benefits to be realised it is vital that Public Health organisations, such as the PHLS or HPA, that lie outside the immediate jurisdiction of the NHS Information Authority, are given ample opportunity to contribute to discussions on the development and implementation of initiatives such as the Electronic Health Record project.

33. With these advances, however, comes the expectation that the effort required to provide, manipulate or access those data should be less. Within the PHLS there has been significant investment and advances made in the capture and manipulation of data derived from newer diagnostic technologies based on the analysis of the nucleic acid (the genes) of micro-organisms, particularly in reference laboratories such as CPHL at Colindale (see later reference to Bioinformatics). Similarly, investment in IT systems procurement and in-house development of statistical programmes have realised significant advances in the PHLS ability to analyse and disseminate data from the national surveillance database (labBase2). However, the implementation of electronic data capture of routinely generated microbiology investigation results from PHLS and NHS laboratories has proved a more difficult nut to crack. Although the PHLS has developed software that has been successfully implemented in a range of laboratories in England and Wales, the full implementation of this mechanism of electronic data capture continues to be difficult to achieve, because of the lack of IT system and data coding standards within laboratories and the seeming lack of IT resources available to the NHS, particularly for the implementation of systems that are not directly supporting clinical care.

34. Advances in information technology have also led to increased expectations of users as to the volume of information that may be accessed, and of the ease and speed with which it may be accessed. In particular, the Internet and its associated technologies have provided unprecedented access to information for professionals and public alike. World wide web technologies for the dissemination of information have been exploited by the PHLS and others for the delivery of communicable disease surveillance information. These technologies have also been used for the capture of surveillance data.

35. Reference laboratory developments in molecular typing and subtyping of organisms had added greatly to the power of surveillance systems in detecting outbreaks and significant trends, and led to greater understanding of disease epidemiology and sources of infection. For example the recent development of typing system for cryptosporidium has shown that while some organisms are found in both humans and other animals there are others that only appear to infect humans.

36. Diagnostic technologies have now advanced to the point of being able to identify the actual genetic code of organisms found to be causing illness in humans. This opens up new possibilities in respect of patient management and surveillance. It may soon be possible to tell within hours, or even minutes, whether a patient with tuberculosis has an antimicrobial resistant strain, whereas this can take weeks using existing culture-based methods. The potential uses of these new technologies for surveillance and epidemiological studies are as, if not more, exciting, with the possibility of fingerprinting organisms. The processing of the large and complex sets of data that these diagnostic techniques generate has given rise to a new scientific discipline, known as Bioinformatics, which has been identified as a priority for development within the PHLS, in view of the potential benefits that it offers for microbial epidemiology, surveillance, outbreak management, and patient diagnosis and management.

37. The impact of near patient testing is as yet unknown. The main drive for the use of such tests may well, in the short term at least, come from the pharmaceutical industry, with the promotion of over-the-counter tests for infections for which over-the-counter medication is available. Such testing has the potential to undermine existing laboratory reporting but also has the potential to provide an important platform for greatly improved clinical reporting, particularly if linked to the electronic health record project, and if the electronic health record project is linked to public health requirements. These issues are discussed in a BMJ article7.

38. The PHLS has nationally and internationally recognised expertise in the development and application of mathematical modelling and statistical techniques to surveillance. Example of advances in Mathematical/statistical technique analysis by the PHLS include:

— Automated outbreak detection systems that have been developed and deployed by CDSC, have been since adopted and adapted by RIVM in the Netherlands.

— Modelling to predict future trends and to assess likely impact of interventions (particularly powerful when combined with economic data and modelling), has contributed significantly to understanding and policy development on HIV/AIDS and vaccine preventable diseases.

— Geographical information system (GIS) developments—relatively underdeveloped as yet, and mainly used for outbreak investigation, but a potential powerful tool for detection of outbreaks and identification of exposures eg in combination with water supply, food distribution or veterinary data.

39. As well as technological advances, there have been significant advances in the range of data sources used for communicable disease surveillance in recent years. The most important of these is probably NHS Direct, with which CDSC has developed reporting algorithms and surveillance systems for the most common infectious disease syndromes, and also for alert conditions that might indicate the deliberate release of the most likely agents to be used in a bio-terrorist attack. This system has recently attracted interest from the USA, where similar systems are being proposed as part of the development of national preparedness for bio-terrorist activity.

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 PHLS has an excellent record of working with the Joint Committee on Vaccination and Immunisation (JCVI) and others, for example in the much praised4 introduction of meningococcal C vaccine in 1999. Using its network of laboratories, the PHLS has been involved in field studies, undertaking surveillance related to vaccine trials and programmes, and monitoring potential adverse effects. Albeit the very many technical challenges, there are still many other infections that remain potentially vaccine preventable. Many of the practical barriers to making good progress are described in another submission to this Inquiry8, together with personal views on the strategic approach needed in the future. This submission from a PHLS expert team reinforces concerns expressed in this document over how national surveillance will continue and flourish under the new arrangements.

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

41. In recent years the PHLS has produced overviews of communicable diseases, with a ranking of infections judged to be of the greatest significance. The last exercise was in 1999. The methodology to produce the tables shown involved asking CsCDC and GUM physicians as well as PHLS staff9, with a separate exercise for those with a primary care perspective10. There was no formal weighting according to the actual and recorded burden of disease, and assessment of the potential for health gain (arguably the most important criterion to influence investment) was subjective.

Communicable diseases of highest public health priority 19999
Ranking of infectious disease by burden in primary care 199910

1 upper respiratory tract
2 Meningococcal 2 tonsilitis/pharyngitis
3 Chlamydia trachomatis 3 otitis media/externa
4 Influenza 4 urinary tract infections
5 Tuberculosis 5 acute cough
6 MRSA 6 diarrhoea
7 E Coli 0157 7 dyspepsia/helicobacter
8 Salmonellosis 8 viral rashes
9 Campylobactor 9 vaginal discharge
10 Helicobacter pylori10 leg ulcers
11 TSE11 sinusitis
12 Hepatitis C12 headlice/scabies
13 Pneumococcal disease13 bacterial skin infections
14 Hepatitis B14 fungal skin infections
15 Clostridium difficile15 cellulites
16 Malaria16 genital chalmydia
17 Staphylococcus aureus17 chronic fatigue/ME
18 Gonorrhoea18 chicken pox
19 RSV19 penumonia
20 cryptosporidium20 antibiotic resistance surveillance

42. Threats could include those to mortality (head count or years of life lost), morbidity, economic impact or political risk. Whichever way infectious threats are assessed, however, an influenza pandemic ought to come at the top of the list. The view in Getting Ahead of the Curve was that it is not a matter of if but when there is another flu pandemic. Although global and national influenza surveillance is in place, the ease of international and domestic travel and the changed structure of society could well lead to an international mortality in tens of millions, as in the 1918-19 pandemic. Limitation in supply of vaccine to a new strain, with the inevitable delay in manufacture, could produce real difficulties for health and social care economies in the UK. These are already operating with high utilisation rates and little spare capacity, and yet would be expected to cope with a major surge in demand over a several week period.

43. While pandemic influenza presents a major and unpredictable threat, the annual (albeit variable) influenza epidemics in the UK, along with infections due to other common respiratory viruses, account for greater morbidity and mortality than infrequent influenza pandemics, though not necessarily greater years of life lost. The opportunity to intervene effectively against influenza has been increasing substantially in recent years and is likely to continue to increase. Increased vaccination uptake has been successfully promoted and more effective influenza vaccines are on the horizon. Effective anti-influenza drugs, with little in the way of troublesome side effects, are now coming on to the market. Near patient tests offer the promise of more rapid individual clinical diagnosis (and treatment) as well as novel methods for influenza surveillance. Vaccines against some of the other respiratory viruses are also being developed. In the light of these developments, enhanced surveillance and assessment of disease burden, continuing development of microbiological methods, and research are essential both for epidemic and pandemic influenza.

44. HIV/AIDS headed the 1999 priority list and the prevalence of HIV is rising steadily. The UK made an excellent start in the fight against HIV as it undertook early mass behavioural interventions against AIDS and HIV from circa 1986 before infection had had much of a chance to penetrate. However the infection is now proving difficult to contain with unacceptable levels of transmission among gay men and steadily rising numbers of heterosexually acquired infections. While the majority of these are acquired abroad, increasing numbers are now acquired in the UK. The numbers of people living with HIV in the UK is forecast to rise from 27,000 in 2002 to 36,000 in 2004. There is also a growing international spectre of anti-viral resistance which requires careful monitoring.

45. Genital chlamydia is of importance because its association with infertility. Recent trials with which the PHLS has been associated have shown the potential for health gain through opportunistic screening in primary care.

46. Tuberculosis now poses a substantial public health problem in some areas of England and Wales and in some population subgroups. Difficulties with the control of the disease are compounded by high rates of new disease in people recently arrived from high prevalence parts of the world, the HIV epidemic, homelessness and drug resistance. The PHLS (HPA) has a central role to play in the development and implementation of the national action plan announced in Getting Ahead of the Curve. Microbiological diagnosis, drug sensitivity testing and epidemiological typing are key elements in the control strategy along with the development of better methods in all these areas. Strengthened epidemiological surveillance is also essential for determining the success of control activities and shaping future control policy.

47. Gastrointestinal infections were given little attention in Getting Ahead of the Curve, in spite of them being common experience of all members of the population, with one in five affected by infectious intestinal disease each year. The annual cost to the nation is in the region of three-quarters of a billion pounds.11

48. Norwalk-like viruses (NLV) account for the major burden of recognised gastrointestinal infection, the greatest impact of outbreaks being in hospitals.12 NLV have been prominent in the media headlines this summer with large outbreaks in hospitals leading to ward closures. These, in turn, lead to disruption of services, including operations—with adverse consequences for the Government's Waiting List initiative. The epidemiology of campylobacter infection, the major bacterial pathogen causing gastrointestinal infection, is still poorly understood, though recent studies are helping shed light on potential inter-species differences in disease transmission.13 Whilst fortunately uncommon, Verotoxin producing E.coli (0157) can result in severe chronic sequelae, including renal disease. The most recent major outbreak in the UK took place in Scotland in 1997, and the subsequent inquiry14 commented unfavourably on some aspects of the laboratory arrangements there. This could be a warning for England when the PHLS network is lost.

49. Helicobacter pylori is a problematic but common infection, generating large prescribing costs in primary care15. Hepatitis B and C are similarly diseases where the costs of treatment are mounting in the light of technical advances and a better appreciation of the possible long-term consequences.

50. There are lessons from the handling of the Foot and Mouth Disease (FMD) epidemic16 for the investigation of animal diseases generally, some of which, unlike FMD, might be a zoonotic risk to humans. Work on human and animal health continues to need to be better integrated with joint work programmes and some joint budgets for use at regional and local levels for surveillance and control.

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

51. Various suggestions have been made in the above paragraphs for how systems could be improved, but in order to answer this question adequately there needs to be a secure evidence base. This may well be present for the introduction of a new vaccine, or the introduction of new screening, but rarely is it otherwise the case. Such evidence would need to benefit from health economic and behavioural science input, with the potential for health gain as the driving factor. Whilst there are many areas of infectious disease prevention and control which do not lend themselves to randomised control studies, there are some new methods being developed for assessing the evidence base for prevention and control interventions.

52. A weakness of Getting Ahead of the Curve is its lack of analysis of the strengths and deficiencies of current infectious disease surveillance, control and prevention arrangements. In this respect, it would be of interest for the evidence base to be shared that justified the organisational changes proposed in Getting Ahead of the Curve and how this policy could be delivered whilst remaining resource neutral. One route to securing such evidence is to evaluate changes post hoc. Whilst others might well learn from experience in the implementation of Getting Ahead of the Curve in England, were this formally evaluated, the English might be able to learn from evaluation of the proposed Welsh health protection model, and from that of the implementation of Scottish plans for health protection, yet to be announced.

53. Some policy interventions can be sparing of resources, and these have the potential for the greatest impact for the smallest pain. For example, carefully drafted central guidance and clear advice can have impact far beyond the minimal cost of generating the guidance, although the implementation may well prove expensive. Updated advice to local health and social care economies on how best to cope were there another flu pandemic is overdue from DH, in spite of this being a WHO requirement17. Were the GMC to reinforce with all doctors the need to recognise their population/public health as well as clinical responsibilities, we might see improved reporting of outbreaks. There are some areas left to doctors which could benefit from opening up to other suitably trained health care professionals, which could save money as well as improve results: giving TB health visitors limited power to prescribe would be one such example. The recording of and learning from outbreaks, adverse incidents and near misses ought to be resource-releasing too, especially if the trend towards increasing litigation continues. The same applies to the continued effort to reduce health care associated infection, including relatively simple measures like hand hygiene practices, and programmes on the insertion and maintenance of intravenous and urinary catheters.

54. Other areas need additional resources, with the amounts being well justified by the health gain generated. For example, surveillance is threatened without adequate support from the public, and the DH and CMO are well placed to ensure that support is forthcoming. Surveillance would benefit most from policy interventions that encourage or otherwise facilitate the flows of data and information that are necessary for informing timely and effective interventions. Priorities in this respect include:

— Promulgating public information and professional guidance on the uses of patient information for public health purposes.

— Greater promotion of the development and adoption of common standards for information systems within the health service, particularly with respect to coding schema and data interchange formats.

— Ensuring that key developments, such as the electronic patient record and the electronic health record projects, meet public health requirements as well as clinical care requirements.

— Consideration of how best to ensure reporting by laboratories (particularly if current generally good levels of reporting are compromised by restructuring of laboratory services as a result of either implementation of Getting Ahead of the Curve or pathology modernisation).

— Ensuring that appropriate priority is given to resourcing of information system developments that support surveillance.

— Making available R&D funds for development of information systems that will support surveillance, particularly in respect of surveillance within primary care and the capture of results from near patient testing.

55. Beyond the health service, there is a need for policy that will promote a more systematic approach to testing of animals, food and water for pathogens that represent a public health threat to man. At present, for example, many important zoonoses are only tested for on an infrequent and sporadic basis by veterinary agencies because the organisms have little health or economic impact on the animals from which humans can acquire infection.

56. For now, much PHLS effort is being spent on how best to retain the current strengths of the PHLS whilst moving to the new structures. The Board has already put on record that taking more time to introduce the changes would increase the likelihood that current good work is not lost in the upheaval. In the absence of any evidence to justify the proposed speed, this is put forward as the one policy intervention above all which would have the greatest impact. Where transfers prove not straightforward, delaying the changes for a year would increase the chance of the transition being concluded safely. It should be noted this would not mean that progress could not be made on many other fronts, or in other locations.

Conclusion/Major Points

57. The PHLS network has played a major part in controlling infection and communicable diseases in the past. Following the infectious disease strategy from the CMO, England, the staff as a whole and the constituent parts are now looking to working within new structures. Whether based within local NHS Trusts, within the HPA or in the National Public Health Service—Wales, staff of the current PHLS hope and expect to be able to continue contributing their expertise to the fight against infection. This submission has outlined some issues that need to be addressed to help that fight. The most important of these are outlined in the box.

Key Points in Evidence from the PHLS

— Take time to achieve change, resource it adequately, identify and deal with risks to business continuity, carry those affected through the change process, and evaluate change carefully. From the PHLS perspective, the process of generating and implementing the strategy Getting Ahead of the Curve has fallen below the high standards normally expected.

— Resources, whether human or financial, have to match expectations. It is hard to see how this is the case, if the implementation of Getting Ahead of the Curve is to be resource neutral.

— Ensure shared ownership of surveillance by those who generate the data, whether clinicians, microbiologists or epidemiologists. Improved feedback to those working at a local level may improve cooperation, but financial and other practical barriers may need to be identified and removed too, eg funding for public health work, including reporting to CDSC.

— Harness new technology, particularly information technology, to improve recognition and reporting of infections. Substantial additional investment will be required.

— Move away from passive surveillance to techniques involving less biased selection of samples.

— There is productive synergy between routine work for the NHS (clinical diagnostic or field investigation), R&D, and enhanced public health activities. It will be important not to lose these benefits in the new structures either from separation at a local level or from separation of local activities from work needed at a national level.

— Surveillance and communicable disease control would be assisted by an acceptance of population and public health responsibilities by all clinicians.

— Enhance the evidence base for dealing with infections, recognising the importance of development as an integral part of the specialised laboratory work needed for surveillance in a changing world.

— Update the law relating to infectious diseases to recognise new problems, new structures and modern attitudes to human rights.

— Inform and educate the public about infections and how the responsible use of data can help protect them and their families from disease.

59. References

1. PHLS formal responses to the consultation document on creating the Health Protection Agency and to the Discussion paper on the future contribution of microbiology services in the public health regions. On info/index.htm

2. Letter from the chair of the PHLS to the Secretary of State 23 September 2002. On info/index.htm

3. Infection Control in the Community study June 2002 on

4. Modern policy-making: ensuring policies deliver value for money. Report by the Comptroller and Auditor General. HC 289 November 2001.

5. PHLS Research and Scientific Strategy Committee: report on the implementation of the theme recommendations from the PHLS review. September 2002

6. Letter from CMO and the DH Permanent Secretary September 2002 on the future arrangements for microbiology laboratory services on

7. Borriello S P. Near patient Microbiological tests; BMJ 1999; 319: 298-301

8. Zambon MC, Brown DWG, Miller E. Submission to this inquiry 2002

9. Horby P, Rushdy A, Graham C, O'Mahony M on behalf of the PHLS overview of communicable diseases committee. PHLS overview of Communicable Diseases 1999. Communicable Disease and Public Health 2001; 4:8-17

10. McNulty CAM, Smith GE, Graham C on behalf of the PHLS primary care coordinators. PHLS primary care consultation—infectious disease and primary care research and service development priorities. Communicable Disease and Public Health 2001; 4 18-26

11. Food Standards Agency. A report of the Study of Infectious Intestinal Disease in England. 2000 London: The Stationery Office.

12. Meakins SM, Adak GK, Lopman BA, O'Brien SJ. General outbreaks of Infectious Intestinal Disease (IID) in Hospitals, England and Wales, 1992-2000. J Hosp Infect (in press).

13. Gillespie IA, O'Brien SJ, Frost JA, Adak GK, Horby P, Swan AV, Painter MJ, Neal KR and the Campylobacter Sentinel Surveillance Scheme Collaborators. A case-case comparison of Campylobacter coli and Campylobacter jejuni infection: A tool for generating hypotheses. Emerging Infect Dis 2002; 8: 937-42.

14. The Pennington Group. Report of the circumstances leading the 1996 outbreak of infection with E Coli 0157 in Central Scotland, the implications for food safety and the lessons to be learnt. Edinburgh. SO. 1997

15. See submission to this Inquiry from the Helicobacter Working Group 2002.

16. Anderson I. Foot and Mouth Disease 2001: Lessons to be Learned Inquiry. HC 888. The Stationery Office. July 2002 ISBN 0-10-297624-4

17. Influenza Pandemic preparedness Plan. The role of WHO and Guidelines for national and regional planning. Geneva, Switzerland. April 1999. On

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