House of Commons - Science and Technology

Select Committee on Science and Technology Eighth Report

4 RESEARCH, DEVELOPMENT AND PROCUREMENT

SURVEILLANCE

Public health service

85. The surveillance of clinical infectious diseases in England and Wales is co-ordinated through the Communicable Disease Surveillance Centre (CDSC) of the PHLS. In the clinical setting, notifiable diseases, as specified in the Public Health (Control of Disease Act) 1984 or the Public Health (Infectious Diseases) Regulations 1968, must be reported by the medical practitioner to the Consultant for Communicable Disease Control, who will then pass the data on to CDSC. We understand that CAMR provides such information directly to CDSC using electronic means.

NHS Direct and others surveillance techniques

86. The Government's evidence to the inquiry says the data that NHS Direct provides could provide an early warning of the effects of a biological attack and complements the existing national schemes of clinician, and routine and specialist laboratory reporting systems that capture illness at a slightly later stage. It says that the system is likely to be at its most effective once an attack is suspected or confirmed, as it would provide an early assessment of the potential extent of an attack.[94] The service, which receives 7.5 million calls a year, seems to have great potential if used alongside other surveillance techniques. According to John Hutton, Minister of State for Health, "All NHS Direct staff have been trained in the rationale, mechanism and importance of their surveillance programme, set up to detect outbreaks of infectious diseases. Analysts have been trained to deliver daily surveillance reports".[95] Dr Maureen Baker from the Royal College of General Practitioners told us that the UK should "move towards a more integrated surveillance system which uses the data from in-hours general practice, which uses NHS Direct data and possibly in the future uses data from out-of-hours primary care and Accident & Emergency centres".[96] In the US we heard attempts were being made to monitor the purchase of drugs, such as analgesics, at pharmacies to assess public behaviour and track illnesses for which people seek over-the-counter treatments. The British Medical Association argues that "Disease control and surveillance measures should be enhanced to aid early detection of pathogens, and extra resources should be made available for research into early warning and identification of biological warfare agents".[97] The use of NHS Direct data to give an early warning of a CBRN attack is a useful addition to the existing surveillance techniques but it should form part of an integrated surveillance system that uses data from a variety of sources.

World Health Organization

87. The WHO has a Communicable Disease Surveillance and Response division. This includes a global alert and response system which gathers official reports and rumours of suspected outbreaks from a wide range of formal and informal sources. Formal reports of suspected outbreaks are received from ministries of health, national institutes of public health, WHO regional and country offices, WHO collaborating centres, civilian and military laboratories, academic institutes, and non-governmental organisations. WHO publishes a Weekly Epidemiological Record with "rapid and accurate dissemination of epidemiological information on cases and outbreaks of diseases under the International Health Regulations and on other communicable diseases of public health importance". Following the use of anthrax spores in the US, WHO set up a Chemical and Biological Weapons Working Group to share information, activities and experience.[98] We heard concerns in the US that the WHO surveillance mechanisms were not well resourced and it had set up its own Emergency Operations Center at CDC. The World Health Organization provides a valuable resource in the response to CBRN terrorism and it should not be under-resourced. We recommend that the Government raise this issue at the appropriate forum.

INDUSTRY

88. The UK has a successful pharmaceutical industry and we were interested to establish what role it could play in developing CBRN countermeasures. Dr Philip Wright of the ABPI told the Committee about its development, with the BioIndustry Association, of a Bioterrorist Task Force which aimed to start exploring with Government what industry could contribute. He said that "It has been somewhat problematic. … there was not a clear dialogue and I think consequently the industry has probably found it quite difficult to know how to provide assistance or respond to any potential future requests for assistance without some sort of more positive dialogue".[99] The ABPI says this "contrasts strongly with the approach of the US".[100]

89. The problems for industry are summed up by the Academy of Medical Sciences: it is "unrealistic to expect industry to respond in the absence of a definable market - the issue is not just one of market, but also of capacity to react rapidly to an emergency".[101] PowderJect highlight the sharing of potential liabilities and intellectual property rights as issues which require careful consideration in collaborative ventures.[102]

90. Some believe that the Government needs to provide, at the very least, clear information about where its policies lie and what sort of market might emerge. PowderJect argues that vaccines which may be developed against biological weapons do not necessarily follow traditional commercial market forces so some pump priming by the Government is necessary. It says that "a proactive anticipatory programme is needed between Government and industry in key areas if an effective UK biodefence strategy is to be implemented".[103]

91. The ABPI says that "existing anti-infective medicines are likely to be the best approach to responding to a potential incident." However, they claim that they have not been approached by Government to "discuss or suggest possible medicines already licensed in the UK for additional indications against putative biological threats." They do not know if individual companies have been approached in this regard.

92. The ABPI states that it has been in contact with the Home Office, DTI and other Government Departments over the last 18 months in order to ensure that appropriate expertise in industry was shared among key stakeholders. It reports the overall outcome of this contact to have been "a little disappointing" and that there had been a reluctance to discuss potential threats.[104] Acambis also report difficulties in conducting an open dialogue with the Government. PowderJect complains about the lack of clarity over the Government's objectives and is unclear about whether any increases in Government-funded research have occurred in any of priority disease areas. It argues that industry is keen to contribute to the development of new products but that "Government must share some of the risk involved in developing products for which there is no guaranteed market".[105]

93. David Harper from the DoH stated: "We do talk to industry. Clearly with vaccine procurement and development in the general sense … there is a dialogue with ABPI and others and we have spoken specifically with industry in regard to the smallpox vaccine procurement". Richard Scott from Dstl also felt that there had been worthwhile interactions with industry: "As far as MoD is concerned with their vaccine development programme, they use industry widely, and we do talk to them about our requirements. We have them involved".[106] We accept there has been contact between Government and the pharmaceutical industry to discuss medical countermeasures but it has been insufficient to enable companies to adapt their own research programmes with confidence.

94. We were pleased to detect a shift in Government thinking during the course of our inquiry. John Hutton told us that "We have had discussions with the industry on an ad hoc basis, particularly when procurements are coming up and we need to re-stock or re-equip. I think there is a case now for us to look at a more strategic relationship with the biotech industry, and I will be taking that forward myself".[107] We are pleased that our probings have prompted action to improve the dialogue with the pharmaceutical industry and that Mr Hutton accepts the criticism that the existing dialogue with the pharmaceutical industry has been inadequate.[108] We are less pleased that it took Ministers so long to recognise the crucial role that industry must play in developing biomedical countermeasures. We look forward to learning of his progress in the Government's response to this report.

BioShield

95. In his January 2003 State of the Union Address, President Bush announced Project BioShield—an attempt to develop and make available modern, effective drugs and vaccines to protect against attack by biological and chemical weapons or other dangerous pathogens such as smallpox, anthrax, and botulinum toxin. Project BioShield is designed to:

Ensure that resources are available to pay for "next-generation" medical countermeasures;
Strengthen NIH development capabilities by speeding research and development on medical countermeasures based on the most promising recent scientific discoveries; and
Give FDA the ability to make promising treatments quickly available in emergency situations.

96. Use of this authority is currently estimated to cost $6 billion over 10 years. Funds would also be available to buy countermeasures to protect against other dangerous pathogens, such as Ebola and plague, as soon as scientists verify the safety and effectiveness of these products. The US Congress has yet to pass the necessary legislation and there are reservations about the way the money would be allocated since the Bill requests permanent indefinite funding authority and this could threaten other federal budgets.[109] Under the programme, the US Government would create a new market for anti-bioterror products by purchasing vaccines or therapies once they are developed. The idea is to encourage research companies to work on vaccines against illnessess caused by potential agents such as anthrax or botulinum toxin which occur so rarely in a natural setting that few, if any, companies are researching them.

97. Philip Wright of the ABPI said he thought that BioShield "seems to have covered and thought of all the main issues" and that the US approach is more effective in that BioShield "provides not just one perspective which is a research-based capability but also the pull through, and also considers how to create the market or the incentive for companies to produce the defence agents that may be required".[110] The scheme is not without its critics in the US. In an article in the Washington Times on 9 July 2003 Drs Tara O'Toole and Thomas Ingelsby of the Johns Hopkins Center for Civilian Defense Studies describe Bioshield as a "modest tweaking of market forces" and compares the US Government's investment in biodefence with the $6.8 billion being spent in 2003 on missile defence research.

98. It is debatable whether a UK BioShield would be an effective use of resources. Some could argue that the UK can take advantage of the incentives that would be provided by the American taxpayer. There is some truth in this but it is important to recognise that US and UK policies will not necessarily be aligned, as we have already witnessed in the contrasting approaches to smallpox vaccination. If US Congress passes the legislation we feel that the UK could benefit from an active dialogue with those companies in the US bidding for contracts awarded under Project BioShield.

99. The Treasury has shown an enthusiasm for stimulating private sector R&D through the tax system and we were anxious to know what discussions Mr Hutton had had with his colleagues in the Treasury as to how best to provide incentives for industry with regard to biodefence. His evasive answer leaves us concerned.[111] It is hard to understand how meaningful incentives can be put in place without the Treasury's involvement. We would have liked to see an acknowledgement of this. We were pleased to see the House of Lords inquiry into Fighting Infection express similar concerns in relation to vaccines: "We believe that … the Government should … create financial incentives to enable early research, development and commercialisation of vaccines".[112] The UK is a relatively small consumer for the global pharmaceutical industry and it is in a weak position to provide powerful incentives to develop particular products. A UK BioShield is not justified but there is much the Government could achieve, in collaboration with the pharmaceutical industry, to improve the market for medical CBRN countermeasures.

AGRICULTURE

100. The response of the Department for Environment, Food and Rural Affairs (DEFRA) to CBRN terrorism is relevant in three ways:

Agriculture may be the target or may be adversely affected, with economic implications;

Some animal diseases, notably anthrax and tuberculosis, can be transferred to humans;[113] and
Experience and expertise in tracking and monitoring animal infectious diseases may be of value in developing countermeasures.

101. Animal diseases are divided into A list and B list infections, in a similar manner to human agents. These are categorised by the Office Internationale des Epizooties (OIE). List A diseases have the potential for very serious and rapid spread, are of serious socio-economic or public health consequence and are of major importance in the international trade of animals and animal products. Examples are foot and mouth disease, rhinderpest, Rift Valley fever, bluetongue, African horse sickness, classical and African swine fevers and avian influenza and Newcastle disease. List B diseases, such as anthrax, are considered to be of socio-economic and/or public health importance within countries and are significant in the international trade of animals and animal products.[114]

102. Before 11 September 2001, List A agents were subject to a range of controls.[115] DEFRA says it invests around £40 million anually into animal welfare and disease research. The current value of projects relevant to contingency plans and their use by terrorists is £16 million.

103. The foot and mouth epidemic of 2001 has the potential to inform future control strategies for animal diseases. If the Government has learnt from the three inquiries it commissioned and the report of the Environment, Food and Rural Affairs Committee, it should be in a good position to tackle any major outbreak of disease.[116] The Government would do well to heed the findings of the US National Academies. In their report Countering Agricultural Terrorism, they stressed that an intentional attack could differ from the accidental spread of a disease: an agent could be introduced covertly into remote areas and multiple sites; covert trasmission is more likely to result in the survival of a pathogen in transit; a more virulent strain is likely to be selected; and the release is likely to be timed for the greatest chance of success.[117]

104. Professor Graham Pearson from Bradford University points out that while the surveillance of human pathogens is conducted by the WHO, animal pathogens are monitored by the OIE and plant pathogens by the Food and Agriculture Organization (FAO). He reports that "the coordination between these three bodies leaves much to be desired". He says that although the WHO has addressed question of responses to chemical and biological attacks of humans, "there is no sign of any comparable response to biological attacks against animals or plants". Professor Pearson argues that the UK, as a member of both the OIE and the FAO, should in conjunction with the EU request that the OIE and FAO, in consultation with the WHO, prepare response plans for countering deliberate attacks against animals or plants. The international surveillance of biological agents should embrace animal and plant diseases as well as human ones. We recommend that the Government take action to improve the coordination between the relevant international bodies.

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