Guidelines on scientific advice

52. One of the roles of the Government Chief Scientific Adviser (GCSA) and his colleagues at a departmental level is to ensure that the GSCA's guidelines on how scientific advice should be used in policy making are followed. Consultation with relevant experts is a key component of the scientific advisory process. The Guidelines for Scientific advice and policy making that were current at the time of the Directive's adoption stress that departments, when identifying the need for scientific advice, should draw on "a sufficiently wide range of the best expert sources, both within and outside Government". They specifically mention Research Councils, industry, academia, professional bodies and learned societies.[128] In the updated guidelines of November 2005, this advice is maintained, along with an emphasis on obtaining a broad spectrum of advice. The guidelines state that:

"When deciding which external experts sources to seek advice from, departments should encourage those responsible for individual issues to cast their net wider than their traditional contacts and continually establish new networks in order to capture the full diversity of good evidence-based advice.".[129]

The 2005 update provides sensible elaboration on the need for a broad basis for scientific advice, but this principle was well established during the period in which the Directive was under consideration.

Sources of advice

53. One of the aims of our over-arching inquiry is to examine the impact that the departmental Chief Scientific Advisers (CSAs) are having on the policy making process. In this case study, we have found no evidence of any involvement from either the Chief Scientist at the HSE or departmental Chief Scientific Adviser at the Department of Health (DH) in the provision of advice on the Directive. The Chief Executive of the HSE, Mr Podger, told us that on these types of specialist issues, "you would not normally expect to ask the Chief Scientist or the Chief Scientific Advisers … In general terms, specialist issues on directives would be considered by HSE with the relevant public bodies, which was done by colleagues in the HPA, and it would also be considered with the relevant stakeholders."[130] Ministers delegated responsibility for policy on the Directive to the HSE and the NRPB without ensuring that there was an alternative scientific input, or any challenge, from a CSA, to the views put forward by these bodies. In view of the expenditure committed by the DH on new MRI scanners, it was especially remiss of the Department not to obtain appropriate advice on the potential consequences of the Directive for MRI use.

54. Departmental Chief Scientific Advisers should be responsible for ensuring that policies are properly informed, where necessary, by scientific advice and that the scientific advice obtained is sufficiently comprehensive and based upon a strong evidence base. They cannot perform this function if they are not involved in policy advice. It should be for the Chief Scientific Advisers and equivalents to determine whether there is a scientific element that needs to be considered in any policy development. This case study demonstrates clearly that the impact of science and on scientific research of a policy is not necessarily easily identified. We are surprised that neither the Chief Scientific Adviser at the Department of Health nor the Chief Scientist at the Health and Safety Executive was involved at any stage in providing advice on the Directive, particularly in view of the high levels of expenditure on MRI equipment at DH. If they are not involved in the policy making process on a subject with such a heavy reliance on science, it is difficult to see how they were operating effectively. We recommend that the DH and the HSE take steps to ensure that their respective chief scientists are actively and routinely involved in the provision of advice informing policy.

55. The Government relied on the HSE and the NRPB/HPA to advise and to negotiate on the Directive during the legislative process. The Minister with responsibility for the HSE, Lord Hunt, explained that while he has overall responsibility, "I take advice from the Health and Safety Commission and they, in turn, are advised by the Health and Safety Executive. In the question of the scientific issues that are under discussion, formal advice is received from the Health Protection Agency."[131] The HSE has responsibility for monitoring and enforcing controls on occupational exposures to EMFs,[132] but receives advice on radiation protection from the Radiation Protection Division of the Health Protection Agency, as well as from other sources.[133] The HSE Chief Scientist is responsible for ensuring that its policies are based on the best available scientific advice and, like departmental CSAs, that the Government Chief Scientific Adviser's Guidelines on Scientific Analysis in Policy Making are followed. The HSE reports that this monitoring indicates "good compliance with the Guidelines."[134] On the subject of the Directive and MRI, the HSE states that, "regular discussions have taken place between HSE, DH and the MHRA. This has ensured the consistent and effective application of scientific advice, and HSE's development of policy has taken OGD's [other Government departments] views fully into account."[135] The evidence we have collected does not fully support this assertion, as we set out below.

Engagement with MR community

56. The Government followed its established system for obtaining the necessary scientific advice on the Directive by relying upon the HSE for advice on the Directive. For further advice on the suitability of the limits contained in the Directive, the HSE relied upon the NRPB. The NRPB conducted its own consultations on its guidance, which informed its advice to the HSE. The successful operation of this arrangement for securing scientific advice depends upon the HSE and then the NRPB securing the necessary breadth of scientific advice, as set out in the GCSA's guidelines. It also requires these bodies to relay to Ministers an indication of the degree of certainty in the advice provided. As we have noted, responsibility for advice on the Directive was delegated to the HSE, which appears to have the necessary expertise to be able to advise properly on the full impact of the Directive, or at least to understand when further specialist advice was needed. It has 76 people with expertise in medical science, nine radiation technical specialists, two of whom have expertise in electromagnetic fields.[136] We note that the HSE has made "limited use of external science" because of the difficulties experienced by outside experts in making regulatory judgments, but welcome the fact that this position is being reviewed at present.[137]

57. There were two strands to the consultations on the Directive. The HSE had a responsibility to identify all sectors of the workforce affected by the Directive and the NRPB/HPA was responsible for the provision of scientific advice on the exposure limits proposed and their potential impact. Mr Podger explained that specialist issues in the Directive were referred to the NRPB/HPA to consult with relevant public bodies and stakeholders.[138] The HSE commissioned the NRPB to identify the industrial sectors likely to be affected by the Directive as early as 2001, and there was no mention of the impact on medical MR applications and research in its findings. Early attempts to publicise and explain the impact of the Directive were directed mainly at the electricity and mobile telecommunications industries, the principal ones affected. This emphasis is reflected in the list of organisations consulted by the HSE in producing its Regulatory Impact Assessment and in attendance lists of various international conferences and events held to discuss the Directive. It appears that the MR angle was first considered during 2002: the MRI equipment manufacturers were first informed of the Directive towards the end of that year. The Institute of Physics and Engineering in Medicine confirms that "the commissioning of the Directive is unlikely to have been promoted as a major benefit for the 'healthcare industry'. Hence it is possibly not surprising that the passage of the Directive has seemingly bypassed the healthcare industry…".[139] The NRPB had done a substantial amount of work on EMF, including in the medical field, and should have ensured that it pro-actively consulted appropriate medical practitioners and scientists at the cutting edge of MR research and use, rather than relying on a website consultation. Equally, as we have seen, the HSE had identified in its Regulatory Impact Assessment the fact that MR equipment would be covered, but failed to ensure that appropriate direct consultations took place.

58. Having failed to consult all those affected by the Directive in the first instance, the HSE and NRPB still had an opportunity to revise their advice in response to representations made during and after consultations on the Directive. The table in Box 4 was provided in the joint submission and provides a detailed account of engagement on this issue between the medical/research community on the one side and Government, HSE and NRPB on the other. Neither the HSE nor the Government have disputed the content of this record.

Box 4: Outline of activities of MR community[140]

59. Communication between the HSE and research/medical communities has been a central issue: both HSE and NRPB/HPA are accused by the MR community of not taking their concerns sufficiently seriously until September 2005.[143] A consultation document on revised guidelines was published by NRPB on 1 May 2003, inviting comments by the end of July. It was not until June 2003 that the MR community in the UK noticed the potential impact on MRI use. The British Institute of Radiology first wrote to the HSE and then the NRPB, in July and August 2003 respectively, expressing concerns about the proposed new guidance. No direct response was received until March 2004, when all respondents to the consultation were sent an acknowledgment letter along with the NRPB's current advice. A further letter was sent on 30 July 2004 with the summary of responses to the consultation, some 12 months after the initial deadline for responses.

60. During this time there was contact between the MR community and the HSE. In meetings between HSE staff and MR scientists in August and September 2003 the HSE took the line that the NRPB guidelines, which were essentially those of ICNIRP, being included in the Directive would be enforced by the HSE and that users and manufacturers would need to make the necessary alterations to equipment and working practices in order to comply. This was at a time when the European Council was still in the process of agreeing a common position on the Directive, and there were opportunities to seek amendments. There was no undertaking to explore these concerns further or to relay them to negotiators in Brussels. The attitude adopted by the HSE was not to take the concerns particularly seriously, according to the MR community. The Institute of Physics states that its "bewilderment" at the introduction of the Directive "is exacerbated by the HSE and HPA ignoring the deeply held views of the scientific and medical community … and ignoring the overwhelming scientific advice that has been offered to them."[144] The joint submission states that the concerns of the MR community were described by HSE at a stakeholder meeting in July 2004 as "esoteric and of no interest to anyone else in this room".[145] This statement, which has not been disputed by HSE, suggests a degree of arrogance and disdain which is extremely disturbing to find in what is a generally well respected public body. It was not until Ministers became directly involved with the issue that the HSE began to fully engage with the MR community, in September 2005 (see paragraph 63, below). Given that the concerns raised about the Directive in 2003 coincided with its consideration in the European Council, and that they came from medical practitioners well placed to provide advice, we find the response by the HSE and NRPB/HPA to them highly disappointing. This reaction was characterised by an instinctive and dismissive resistance rather than an attempt to engage and examine. Both organisations acted in contravention of the guidelines laid down by the Government Chief Scientific Adviser.

CONFUSION AT THE HSE

61. The HSE also repeatedly gave wrong information about its intentions on static fields. UKREP worked—under the instruction of HSE—with other Member States in Brussels to have the static fields limits removed from the Directive. This was achieved on 17 September 2003. Yet in a meeting on 19 September 2003 HSE staff in the UK told MR scientists that HSE would still seek to enforce this limit because it was in the NRPB guidance. This commitment by the HSE to go beyond the terms of the Directive to impose tighter restrictions was then repeated at a meeting in July 2004. Here, HSE staff said that the static field limit should not have been removed, in spite of the fact that the HSE had argued since mid-2003 in favour of its removal! When asked for an explanation for this, the Minister acknowledged that the information given at the UK meeting by HSE staff was wrong and that what was said "is not our policy".[146] As late as June 2005, the HSE repeated that it would seek to introduce static field limits in the UK legislation.[147] We have had no explanation as to why this wrong information was being given repeatedly. It is extremely worrying that the HSE managed to outline a policy to the MR community in the UK which was the precise opposite of the one it had been pursuing in Brussels during negotiations. That the HSE could be contradicting itself for such a long period suggests some quite astonishing failings in management and internal communications. We recommend that the HSE seeks to discover how this situation could persist for so long, and takes appropriate steps to ensure that there can be no repeat.

ACKNOWLEDGEMENT OF FAILINGS

62. The Minister, Lord Hunt, acknowledged the failings by the HSE in its consultations on the Directive. He said that the issue "has not been fully considered by the Government, and clearly something went wrong with the process".[148] Specifically, he described the failure of the HSE to go to the medical royal colleges when it initially consulted as a "glaring omission" although he suggested that "it may well be … that the colleges might have been more active.[149] He told us that "I do think that the HSE should have consulted more widely with the medical field, yes".[150] This was endorsed by the Chief Executive of the HSE, who explained "What was not realised at all was that there were these minority of clinical interventions … we had not appreciated it by September 2003."[151] He explained the reasons for the failings in consultation were "that we had consulted with manufacturers and technicians and we had some clinical engagement, although certainly with the benefit of hindsight insufficient—and I would be the first to say that.".[152] We welcome the frank admission of the failings in consultations on the Directive by the Minister and, more pertinently, by the Health and Safety Executive.

63. As well as failing to give proper consideration to the views expressed to it, the HSE failed to communicate these concerns to Ministers until far too late to affect the content of the Directive. On 20 September 2005, the MR community held a press conference to publicise its concerns. This gained significant and sympathetic coverage in many national newspapers and journals over the following few days. It was following concerns raised directly with Ministers by clinicians that the Minister, Lord Hunt, requested a note from the HSE, which was provided on 27 September 2005. The Minister then agreed to meet the Royal College of Radiologists on 20 October and discussed further action (see paragraph 76). Lord Hunt subsequently set up a general meeting for all stakeholders on 5 January 2006 to discuss further action. A report of this meeting has been published. Lord Hunt also met the RCR and HSE later that month. In evidence to us, the Minister regretted that it took so long to be brought to his attention. He told us that "if the issue had come to Ministers before then, a similar kind of process [of action] could have been undertaken".[153] This is not doubted by the MR community. Dr Keevil told us that "It became a different story when we started to engage at Government level" and that the Government was now working with the MR community to find a solution.[154] We acknowledge the Minister's positive response when finally informed of the concerns being expressed about the impact of the Directive. We also welcome his willingness to learn from this episode. He states that "The key lesson is to listen and work with all stakeholders and not become complacent that existing networks are sufficient".[155] We note that it was only when the HSE was asked by the Minister for advice on the concerns raised directly with him that the HSE responded. Without such a direct approach to Ministers, there is little to suggest that the HSE would have taken any action at all.

CONCLUSIONS ON HSE AND NRPB CONSULTATION

64. Both the HSE and the NRPB failed to consult sufficiently widely to ensure the impact on MRI was given full consideration. The HSE identified that MRI workers and equipment would be affected by the Directive but then did not consult the MR community on its impact. It relied completely for advice on the NRPB. For its part, the NRPB was more aware of the potential impact of EMF limits on MRI, having contributed to and reviewed much evidence on the subject, particularly from 2001 onwards. It too failed to consult the MR community and thus its advice to the HSE was incomplete. The Government was badly let down by the HSE and NRPB, not only by their failure to consult sufficiently widely but also by their failure to advise Ministers on the concerns being raised. When informed of these concerns, Ministers acted with commendable speed to investigate further. We welcome the commitment by the Government to rectifying these earlier failings by working closely with the MR community.

Engagement of MR community

65. The failings in engagement activities are not all those of the HSE and NRPB/HPA. There were deficiencies in the time it took the MR practitioners and their professional bodies and research sponsors to identify the potential implications of the Directive and in the way they communicated with their research community and with policy makers.

66. It took the medical practitioners six months from the publication of the Directive to express concerns or seek clarification from the HSE. Dr Keevil, who was in the forefront of activity on this front, became aware of the issue "sometime in the middle of 2003".[156] When medical practitioners and scientists did mobilise, their focus was solely on the proposals on static fields, which were removed in September 2003. UK organisations did not identify the limits for time-varying fields as a potential problem until June 2004, when the Institute of Physics and Engineering in Medicine (IPEM) wrote to the Medicines and Healthcare products Regulatory Authority. The issue was discussed at a stakeholder meeting with HSE the following month.[157] The only evidence we have found of time-varying fields being raised during the negotiations was the letter from COCIR of April 2003 to the Social Questions Working Party considering the Directive. However, the focus of their concerns was also on static fields and the Government reports that the presenters of this paper "appeared content with the removal of static field values only".[158] The HSE was consequently allowed to believe that the MR community was content once static fields had been removed from the Directive.[159] There was still time, in early 2004, for the UK to influence the content of the Directive as it was considered by the European Parliament. Yet the British MEP who was seeking to have MRI removed from the Directive told us that she heard nothing from the UK medical community, or indeed from UKREP in Brussels.[160] IPEM acknowledges that "the scientific community must take responsibility for not bringing matters to government attention in a timely way …" and suggests that there "may be hesitation" in alerting Ministers when concerns are not being addressed.[161] This Committee has sought to promote increased political awareness and engagement in all sections of the scientific community. Unfortunately, the potential benefits of such political acumen were not enjoyed in this case. It is regrettable that the issue of time-varying fields was only raised as a major problem after the Directive had been agreed. We conclude that the MR community in the UK was very slow to consider the impact of time-varying fields and failed to raise it early enough to influence the negotiations on the Directive.

67. This case study has also suggested that there is a disconnect between the MR community and the mainstream medical research community, and, more generally, between medical scientists and the clinicians. In spite of the efforts of the medical practitioners in 2003 and 2004, eminent scientists working on MR remained unaware of the Directive some two years after concerns began to be aired. We were surprised to discover that a leading MR researcher, Professor Ray Dolan, Head of the Wellcome Department of Imaging Neuroscience at University College London, only found out about the Directive in summer 2005 and was then formally notified in October that year.[162] Equally, we find it odd, to say the least, that individual medical scientists knew about the Directive while key funders of MR research such as the Wellcome Trust and the Medical Research Council did not. Given its own research interests and its financial commitment to new MRI equipment, the MRC might have been expected to maintain an interest in a Directive covering EMF. The Chief Executive of the MRC, Professor Blakemore, told us that he did not know about the Directive until around September 2005. The Wellcome Trust became aware around a similar time. In spite of his work with the Weak Electric Fields Group, Professor Blakemore was, surprisingly, not specifically consulted by the NRPB.[163] When it did finally hear about the issue, the MRC was responsive and immediately raised strong concerns with the HSE.[164]

68. The failings in communication throughout the medical research community were threefold: horizontal, across medical practitioners and researchers; top down, from professional bodies and research sponsors; and also bottom up, from practitioners to policy influencers. This comprehensive failure of communication meant that the medical research community was unable to exert any political influence until it was far too late to be effective. We conclude that the professional bodies, the Wellcome Trust, and the MRC were insufficiently pro-active in identifying the implications of the Directive and informing their communities, and politically ineffective in communicating these concerns in Westminster and Brussels. We recommend that the professional bodies and research funders re-examine the development of their links with each other and explore ways in which they can work together to improve their political effectiveness.

Horizon scanning

69. The failure of the medical research community to pick up on the Directive for so long suggests a lack of effective horizon scanning activities, in Government and among research funders. The GCSA's guidelines on scientific advice require departments to have adequate horizon scanning mechanisms in place and ensure that the evidence obtained is appropriately considered and, when necessary, acted upon.[165] We have not considered the full range of Department of Health or Government horizon scanning activities here but have focussed on the mechanisms that are in place to detect issues of interest at an EU level and also on non-ionising radiation specifically.

70. The HSE identifies forthcoming proposals from the Commission by developing its own links with relevant officials there and by liaising with UKREP.[166] We explore its links with UKREP in chapter 6. For non-ionising radiation, there is an Interdepartmental Liaison Group, established in 1994, with specific responsibility for ensuring effective discussion of cross-departmental interests on this subject. It consists of officials from a number of Government departments, including the Department of Health, the HSE, the HPA and the MRC. This Group first noted the possibility of a Directive in June 2001 and was given further updates at subsequent twice-yearly meetings, at which the possible impact was discussed. The Government states that "The MRI issue was mentioned to the group in June 2003 but no action agreed".[167] This group has a sufficiently broad membership to be capable of ensuring that the right organisations were consulted when the Directive was first discussed. It did not identify the potential impact on MR for two years. Even when it did, the Group failed to ensure that key organisations such as the HSE, DH and the MRC fully considered the implications of the Directive and developed a coherent cross-departmental approach to this issue. The Government has in place, in the Interdepartmental Liaison Group on non-ionising radiation, a mechanism for advising on measures such as those contained in the Directive. In this case, the Group failed to identify all departments and agencies affected by the Directive and to consider further the extent of its impact. We recommend that the Department of Health and the Medical Research Council review their representation on the Interdepartmental Liaison Group on non-ionising radiation to ensure that the Group is provided with the necessary breadth of expertise and that they give due consideration to the issues raised by the Group.

71. In addition to its membership of the Interdepartmental Liaison Group, the MRC had the opportunity to become aware of the impact of the Directive through the presence of the UK Research Office (UKRO) in Brussels. This is part-funded by the Research Councils and was set up to provide advice and information on EU research programmes to organisations in the UK. It is well placed to keep an eye on proposed Directives which might impact upon the UK research community and advise accordingly. We were surprised to discover that UKRO seems to make no attempt to provide this service for the Research Councils. RCUK told us that UKRO has "very limited horizon scanning activities" and that it "would not have been expected to pick up on this particular EU Directive".[168] Whilst its focus might naturally be on providing information about funding opportunities to its subscribers, the Research Councils which also fund it might nonetheless expect to see some return in terms of information about EU legislation relevant to their respective communities. We believe that the Research Councils stand to benefit from providing the necessary resources to enable it to fulfil this function.

72. We have identified failures in the horizon-scanning activities of the Government and its agencies, the Research Councils which contributed to the late reaction of the UK MR community to the Directive. The Directive was well over the horizon before the medical research community, led by the MRC, reacted to its potential consequences. There are bodies in place which should, or could, perform this horizon-scanning function, both for the issue of non-ionising radiation and for developments in the EU of interest to the UK research community. That they are not specifically charged with this responsibility is indicative of the low priority given to this important role, which, in turn, results in an absence of established links for feeding this advice and information into the policy making process. We recommend that the Office of Science and Innovation reviews its horizon scanning activities in respect of EU legislation, in consultation with the Research Councils. We believe that there is a strong case for the UK Research Office to perform a horizon scanning function on behalf of the Research Councils.

129   OST, Guidelines on Scientific Analysis in Policy Making, October 2005, para 13 Back

130   Q 921 Back

131   Q 860 Back

132   Ev 37 Back

133   Ev 42 Back

134   Ev 73 Back

135   Ev 34 Back

136   Ev 73 Back

137   Ev 33 Back

138   Q 921 Back

139   Ev 54 Back

140   Ev 14-16. The table has been edited for inclusion in this Report.  Back

143   Q 837 Back

144   Ev 48 Back

145   Ev 45, Q 837 Back

146   Q 905 Back

147   Ev 46 Back

148   Q 909 Back

149   Qq 908-09 Back

150   Q 909 Back

151   Q 872, ev 72 Back

152   Q 872 Back

153   Q 862 Back

154   Q 838 Back

155   Ev 70 Back

156   Q 837 Back

157   Ev 65 Back

158   Ev 71, Q 3 Back

159   Qq 868, 874 Back

160   Private meeting with Liz Lynne MEP, 11 May 2006 Back

161   Ev 55 Back

162   Q 834 Back

163   Q 843 Back

164   Ev 27, 29 Back

165   OST, Guidelines on Scientific Analysis in Policy Making, para 9 Back

166   Ev 74 Back

167   Ev 73 Back

168   Ev 64 Back