The Scottish Executive's Interim Response to the Findings of the Phillips Report of the BSE Inquiry

The Scottish Executive's Interim Response to the Findings of the Phillips Report of the BSE Inquiry

The Scottish Executive's Interim Response to the Findings of the Phillips Report of the BSE Inquiry

The Royal Society of Edinburgh (RSE) is pleased to respond to the Scottish Executive Rural Affairs Department consultation on the Scottish Executive's Interim Response to the Findings of the Phillips Report of the BSE (Bovine Spongiform Encephalopathy) Inquiry. The RSE is Scotland’s premier Learned Society, comprising Fellows elected on the basis of their distinction, from the full range of academic disciplines, and from industry, commerce and the professions. This response has been compiled by the General Secretary with the assistance of a number of Fellows with substantial experience of science policy and scientific advice.

Overall the RSE welcomes the general approach adopted by this interim response. However, while the response indicates a general commitment to providing government in Scotland which is "open, accessible and more accountable to the parliament and to the people of Scotland", there are few specific commitments made. This may be because the Scottish science strategy has yet to be published, although more specific commitments within a clearly defined timetable would have been welcomed.

The Society believes the commitment to retain BSE controls are to be applauded (for example, the animal feed ban, the removal of Specified Risk Material, and the operation of the over 30 month rule scheme - which restricts cattle from entry into the food chain). It would have been premature and indefensible to have considered the relaxation of these measures at this stage. The CJD (Creutzfeld-Jakob Disease) Surveillance Unit should also be praised for its work throughout the BSE/vCJD crisis. Without the Unit the UK would not have become aware of the vCJD (Variant CJD) threat when it did. The Unit, although funded 90% by the Department of Health in Whitehall and 10% by the Scottish Executive, is nevertheless a major academic strength for Scotland and a great reflection on the quality of Scottish science. The Government∂s commitment to better, more timely care for vCJD sufferers (and their families) is also to be welcomed.

Further aspects of the interim response to the findings of the Phillips report are addressed below:

Science and Government

Research

The general initiatives taken by Government to improve the quality of UK science, including the greater degree of open competition for funding, are worthy of praise. However, the comments on Research will become more meaningful when the Scottish science strategy is published. Much hangs on the introduction of a 'consolidated mechanism' to review departmental expenditure within the context of the Executive's priorities. For example, a more robust mechanism to co-ordinate research by the Health Department with that of Rural Affairs Department would strengthen the Executive's hand when food crises (such as E.coli 0157, BSE) come along.

There should also be mechanisms for evaluating the quality and relevance of the research commissioned by Government departments in support of their policy and regulatory activities. In general, Government Departments and agencies can be ‘too distant’ from industry to have a good idea as to what the real risk factors are and how these alter with changes in industrial practice. This problem has become worse due to the drive for Government bodies to be seen to be creating a distance between themselves and any industrial contacts. In addition, the ‘near market research’ policy, which makes a line of separation between what are seen as Government responsibilities and what are seen as industry responsibilities, is too inflexible and needs reconsideration. It can lead to unproductive debates and conflicts over whether a particular piece of work should be funded by Government or industry while the underlying problems, which almost inevitably have consumer/public implications, remain unaddressed. There is now scope for Scotland to adopt an independent policy in regard to research commissioning and to target the funding ‘in the context of the Executive’s overarching priorities’.

The issue of ensuring an effective early warning system, and network of relevant research findings, is also important. While providing useful advanced information, no amount of horizon scanning and early warning systems can completely avoid the unexpected. It will, therefore, be important to invest in a co-ordinated rapid response plan. Sufficient expertise and appropriate resources also need to be retained nationally to allow rapid research responses, and this expertise and resource should be ‘on call’ to government in public sector research institutes. This indicates a need for some continued ring-fencing of resources within the public sector.

Advisory Committees

Many modern science based issues have proved politically intractable because scientific information is inevitably incomplete on any issue at a given time, and because Governments have found it difficult to come to terms with scientific uncertainty, both in formulating policy and in communicating it to the public. The Science Engineering and Technology (SET) resources of the Scottish Executive will, however, be limited in comparison with the diversity of scientific knowledge relevant to important issues of public policy. It will, therefore, be important to make use of the wider SET base in gleaning policy advice, including learned bodies such as the Royal Society of Edinburgh. This is not to say that the Executive should curtail Scottish funding sources such as those of the Health Department's Chief Scientist Office (CSO). Such 'local' funding streams allow issues to be addressed that have particular significance within Scotland and which take fuller advantage of development opportunities.

Over-compartmentalisation between government departments and between scientific disciplines, and lack of co-ordination across the wider SET base, tend to frustrate an effective, integrated use of the science base in policy formulation. However, Scotland does have a system for ensuring that the work of the Health Department's CSO is linked effectively to that of the Department of Health in Whitehall and to the Medical Research Council. For example, Scotland's Health Department's Chief Medical Officer or Chief Scientist sits on the Medical Research Council. This avoids undue parochialism and allows us to get added value from key developments.

Improved communication across the UK, within the Scottish Executive, between the Executive and its Advisory Committees, and between individual Advisory Committees are key issues and should fall within the remit of the new Scottish strategic scientific advisory body as part of the Scottish science strategy. The RSE recommends that this body should advise on strategies for i) the effective integration of research within Scotland as part of the UK SET base; and ii) the efficient exploitation of the SET base to the benefit of society. Responsibilities should be embedded within the Scottish Executive which should permit i) day-to-day implementation of the strategy of the Scottish Executive and the strategic scientific body for the SET base; ii) co-ordination of SET advice to ministers; iii) representation of Scottish interests on UK co-ordinating bodies and relevant DTI/OST committees; and in the EU arena; and iv) a trans-Departmental remit for SET within the Scottish Executive to ensure best use of resources and the cross-disciplinary and cross-sector integration of research and advice when appropriate. These functions should command professional credibility within the UK SET community, with users and with the public, by creating an appropriate post to be filled by a scientist of international repute.

Advisory Committees are a useful mechanism for informing government policy. However, it is important that the committees contain a range of views. The introduction of lay members on the committees has been a worthwhile innovation and there should also be representatives who know and understand industry and practice. In addition, clearly defined roles, tasks and expectations for both advisory persons and advisory bodies should be made public in order to facilitate the early reporting of emerging problems to the relevant body.

Openness

The continuing commitment to open, accessible and accountable Government is to be warmly welcomed and there has been much progress made in creating greater openness. However, much of the development of more open access has been technology inspired. The rapid development of the Internet has created a much greater openness in almost every area of activity – whether related to government or not. Nevertheless, considerable thought needs to be given to designing websites which are user friendly and appropriate for different sectors of society. Careful design should allow people to access that part of the information which they wish to retrieve without the "information overload" referred to as a hazard in the Phillips report.

In opening up government bodies to the general public, the population needs to be treated as responsible citizens who acknowledge uncertainty and the impossibility of absolute safety. The proposed programme will help and should probably be devolved to local levels so that it becomes relevant to supermarkets, farms and schools. Publication of scientific advice and all relevant papers from advisory committees must also be carried out in a timely fashion, otherwise the ability of the wider scientific community to review the advice will be adversely affected, with consequent loss of confidence among the scientific community and the general public. Access to specific data might also be an important factor in allowing full debate to take place, with due regard given to issues of confidentiality.

Freedom of Information

The Freedom of Information Act 2000 should potentially improve matters but its clause to allow exemptions for ‘sensitive information to be withheld from disclosure’ will leave some grey areas that will require public vigilance and scrutiny. In this context, the Scottish Information Commissioner is to be welcomed.

Risk and Uncertainty

The emphasis on better definition and handling of risk and uncertainty is welcome. Public opinion is shifting on these important issues and people want to be informed and consulted. More mature and assured government no longer can claim to have certainty in all matters but should allow the admission of mistakes. In organisations such as NASA, encouragement of this kind of culture leads to much earlier identification of problems with less likelihood of their repetition.

Risk and uncertainty are not the same but rather, separate and distinct. The explicit recommendation to use the precautionary principle is most welcome. However, it needs to be acknowledged for what it is, which is a means of handling uncertainty, and the risks and benefits need to be set out in a way that the public can understand. The costs and benefits of precautionary decisions should also be weighed carefully, both in terms of the diversion of resources to serve a particular strategy with the resulting opportunity cost, and in terms of the risk of over-precaution in certain areas, thereby devaluing the precautionary principle in the minds of the general public.

Identification and quantification of risk involve several disciplines which may not always have worked in harness in the past and which require to be pulled together. The Government’s response to Phillips, however, depends on the introduction of improved (but conventional) risk assessment methodology. This, in various guises, is built on the principles of Hazard Analysis and Critical Control Point (HACCP) methodology. In order, for that type of methodology to work, there is a requirement for a full understanding not only of the risk factors but also of the operational practices that are being applied. However, the Government and its agencies are generally too distant from the ‘front line’ to identify and understand the operational issues. So they tend to close the stable door after some errant horse has bolted. (As a specific example of this, the scale of both legal and illegal imports of meat has only emerged into the public domain after there has been a FMD outbreak.). In regard to Scotland there are specific difficulties in undertaking meaningful risk assessments because much of the statistical information on which such assessments can be based has traditionally not been available specifically for Scotland as a distinct area of the UK. However, this requirement is now being addressed by the Executive and by other agencies.

Risk assessment for events with very low incidence is inevitably a slow process, based on the gradual collection of relevant data. An area where the precautionary principle might usefully be extended is in the statistical analysis of data. The confusion between 'absence of evidence' and 'evidence of absence' when interpreting risk for the public is manifest in the tendency to assume a basis of zero risk, and then to test data for evidence of an alternative hypothesis of actual risk. Hence, the presumption is of safety, and small data sets are typically described as showing no evidence of risk. This both breaches the precautionary principle and is statistically invalid. A more legitimate approach is to formulate on the basis that an appreciable risk is present (defined in advance by the scientist, and hence open to challenge or discussion), and to test the data for stronger evidence of the alternativehypothesis of non-appreciable risk. This formulation presupposes risk, and small data sets would be described as not establishing relative safety.

In addition, presentation of confidence intervals of risk probabilities should be encouraged, since this would illustrate the difference between precise estimates of small risks and imprecise estimates that preclude neither small nor relatively large risks. As part of this, it is vital that advisory committees make clear what assumptions underlie advice, and that uncertainty is emphasised rather than hidden.

Good Government

The commitment to "good government" is welcome. In particular, the section on Chief Medical Officers (CMO) and Chief Veterinary Officers (CVO) is important. The trust that the public place in the CMO is a matter of great importance and should be nurtured. The CMO should be seen as the custodian of the public's health and as the public's advocate when difficult situations confront Governments. The CMO should also be viewed as an objective source of advice to Government and as someone who can speak out without having to toe a party line. At the same time, the CMO must use his/her influence in working with Government in the formulation of relevant policy.

The relationship between the four CMOs is also an area of sensitivity. The relationship was tested in the recent controversy about the lifting of the 'beef on the bone ban' when three CMOs felt that we should await the latest epidemiological estimates before premature relaxation of the ban. No one can legislate to avoid suchdifferences of opinion and the resultant differences in the advice that goes to the Executive in the four parts of the UK. However, the four CMOs continue to meet regularly in a determined effort to avoid giving differing advice to their respective administrations. It can be argued that the ability of all four CMOs to take an objective and independent view is one of the strengths that has followed devolution and this ability must be retained.

In addition, the Society notes that Scottish local authorities (in contrast to elsewhere in the UK) are not obliged to report on their performances in respect of Environmental Health and Trading Standards. This situation should be clarified, with Scottish local authorities required to report on their performance to enable the efficient monitoring of their enforcement policies and procedures.

Legislative Framework

There are genuine issues about the present legislative model applying to Scotland. In most areas that Phillips has addressed, Scotland is bound by the Scotland Act to implement the detail of European Union (EU) legislation. Scotland, therefore, needs to adopt a more direct and proactive stance to policy development and negotiation in the EU. Otherwise, Scotland will continuously be seeking derogation on specific areas of EU legislation that do not fully meet its needs, or will be constantly seeking ways of ‘bending’ EU laws to meet specific Scottish requirements. This is a matter to which the Scottish Executive and the Scottish agencies must urgently devote more time and resources.

Disease Control

It will be important that government strike the right balance between passive and active surveillance. Passive surveillance data has many uses, but care must be taken to ensure that the samples collected by this route do not become overly atypical of the population as a whole. For example, some important human pathogens have their reservoir in farm animals but virtually never (E.coli O157) or hardly ever (Campylobacter) cause significant disease in them, and so they are not effectively tracked by a passive system that is dependent on sample referral by farmers and veterinarians whether the system is free or not. Economic forces may influence the submission of animals to the Veterinary Investigation Centres, and increased subsidy might be necessary to keep these samples representative. Once a disease has been identified as of particular interest, it is probably more appropriate to implement an active surveillance strategy to collect statistically valid data about the incidence and/or prevalence of the disease in a target population. The ability to do this in a timely fashion will in turn depend upon the availability of trained staff and contingency funds and there would be merit in conducting a detailed review of animal and human disease pathogen surveillance across the whole UK

Additional Information
In responding to this review the Society would like to draw attention to the following Royal Society of Edinburgh responses which are of relevance to this subject: The Scientific Advisory System (June 1998); The Food Standards Agency: Draft Legislation (March 1999); The Scientific Advisory System for Genetically Modified Foods (March 1999); Devolution and Science (April 1999); Science and Society (June 1999); Review of Guidelines on The Use of Scientific Advice in Policy Making (January 2000); The OECD Edinburgh Conference on the Scientific and Health Aspects of Genetically Modified Foods (February 2000); Science Strategy for Scotland (July 2000); and Proposed Code of Practice for Scientific Advisory Committees (December 2000).

 

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