Guidelines 2000: scientific advice and policy making

Our comments in italics

 

The principles behind Guidelines 2000 are consistent with those underlying the Government's drive for evidence-based policy, in line with the Government's modernisation programme. The Guidelines are intended to complement more extensive guidance already available on risk assessment and policy evaluation.

The Advisory Council on the Misuse of Drugs and Home Office do not seem to follow guidance on risk assessment, risk management, policy option evaluation or better regulation.

4. The Guidelines apply to ... standing or ad-hoc advisory committees. However, it is particularly important that they are followed carefully where the issues are sensitive, for example where there is significant scientific uncertainty, a range of scientific opinion, or implications for public policy. Departments should use their judgement to apply the Guidelines in a manner which is proportionate to the nature and scale of the issues involved.

Guidelines 2000 applies to ACMD as well as HO. Drug policy is a sensitive issue; drug harm is a great threat to society - Guidelines 2000 should be closely followed as a result.

7. Sources may include:
c) departments' existing expert advisory systems, where members of committees may be specifically asked to draw attention to new areas in the scientific literature. Membership should be kept under review to ensure an appropriate range of scientific opinion is represented;
d) consultation with interested stakeholders and stakeholder groups, including groups representing the interests of consumers and members of the public.
e) issues brought to the attention of Government by the interests directly concerned (e.g. individuals, companies, scientists or lobby groups) or by reports in the media.

ACMD and HO do not seem to consider consultation with drug consumer or trade groups.

8. Departments should also review systematically their medium to longer-term strategies for science and technology spending, as well as their immediate priorities, to see whether funding needs to be directed to programmes of further research to illuminate outstanding areas of uncertainty identified.
9. Departments should ensure they have mechanisms in place for early identification of issues which affect more than one department or agency or have an international dimension, and ensure they have adequate procedures for early provision and exchange of information. Departments should involve the Office of Science and Technology in all substantive or sensitive issues which cross departmental boundaries.

It is strongly in the public's interest to establish which intoxicant drug is the most harmful, alcohol or cannabis; ACMD and Government do not appear concerned with this question though alcohol harm costs society around £20 billion a year and the ACMD have said "the high use of cannabis is not associated with major health problems for the individual or society". This may be seen as a cross departmental issue requiring OST involvement, or the ACMD could take the view that their statutory duty requires them to consider this question since alcohol is undoubtedly a harmful drug.

Obtaining scientific advice
10. Once issues have been identified on which scientific advice is needed, departments should ensure their procedures for obtaining advice are consistent with the steps outlined below.

Getting the right balance of scientific disciplines
11. All relevant scientific disciplines needed to address the problem should be assembled. Departments should at a minimum consult the experts they are proposing to use, in order to ensure the experts themselves feel they can cover all the scientific competencies required. In certain cases departments may need to consult more widely to satisfy themselves that they have assembled all the right disciplines.
Bringing together the right people
12. Departments should draw on a sufficiently wide range of the best expert sources, both within and outside Government. These might include not only eminent individuals, learned societies, advisory committees, or consultants, but also professional bodies, public sector research establishments, lay members of advisory groups, consumer groups and other stakeholder bodies. As all experts will come to issues with views shaped to some extent by their own interests and experience, departments should also consider how to avoid unconscious bias, by ensuring that there is a good balance in terms of the type of institutions and organisations from which the experts are sought. Experts from other disciplines, not necessarily scientific, should also be invited to contribute, to ensure that the evidence is subjected to a sufficiently questioning review from a wide-ranging set of viewpoints.
13. Consideration should be given where appropriate to inviting experts from outside the UK, for example those from European or international advisory mechanisms, particularly in cases where other countries have experience of, or are likely to be affected by, the issue under consideration.
14. Departments should ask prospective experts to follow the seven principles of public life as set out by the Committee on Standards in Public Life, which include the obligation to declare any private interests relating to their public duties. Departments should judge whether these interests could undermine the credibility or independence of the advice.
15. Where departments conclude that the potential conflicts of interest are not likely to undermine the credibility or independence of the advice, the relevant declarations of interests should, as a minimum, be made available to anyone who is proposing to act in reliance upon the advice. Departments will also need to consider whether it is appropriate to make the declarations more widely available.

The Beckley Foundation and Colin Blakemore, Chief Executive of the Medical Research Council, should be consulted. These scientists believe drug regulations for traditional and non-traditional drugs should be consistent, targeted at harmful use and proportionate to harmfulness.Consumer organisations should be consulted. The Royal Society and Lancet point out that the form of appropriate regualtion is not a scientific question.

Ensuring the right questions are asked
16. Departments should consider how best to frame the particular questions which the experts will be asked to answer. At a minimum the proposed questions should be discussed with the experts themselves, in order to ensure the questions to be asked are capable of a scientific answer.

The question at issue is how to regulate harmful drugs. The harmfulness of drugs can be assessed scientifically - any drugs excluded from such an assessment (e.g. alcohol and tobacco) should be noted with a transparent explanation. The most appropriate form of regulation can not be established by scientific methods (see Royal Society & Lancet comments). Instead risk assessments guide comparisons of regulatory options; these take into account many non-scientific factors including the public's risk perception and risk tolerance and international law.

17. Where issues are sensitive, departments should take utmost care that the questions are framed to cover the concerns of all relevant stakeholder groups, including consumers and the general public. In some particular cases it may be necessary to undertake prior public consultation before the terms of the questions are finally settled.

Questions are framed to discriminate between traditional and non-traditional drugs by denying that traditional drugs are drugs. The question of which intoxicant drug is most harmful, alcohol or cannabis, cannot then be asked. Consumers and potential consumers of non-traditional drugs are not consulted; they are denied equal consumer choice and consumer protection by ACMD advice and HO policy.

Give the experts clear guidance on what is required of them
18. It should be made clear to the experts which of the various possible roles they are being asked to perform. These can include: collection and analysis of new scientific data; review of existing data; interpretation of research from different sources; application of expert judgement where data is lacking or inconclusive; identification of policy options open to departments; and providing expert scientific advice upon policy options proposed by departments. Different sorts of expertise may be required for different roles.

ACMD's statutory duty requires them to provide regulatory advice proportionate to risk but they do not seem to have expertise in risk assessment or regulatory options evaluation.

19. Departments should not require experts to come to firm conclusions which cannot be justified by the state of scientific knowledge. Where the science or the technology are uncertain, departments should ask experts to indicate in their advice which areas are uncertain, and to what degree, whether they are critical to the analysis, and what new information might cause them to revisit their advice.
20. Scientific advice is only one element among the considerations which may need to be taken into account by decision makers, which might also include social, political, economic, moral or ethical concerns. Departments will need to judge how and at what stage the scientific and other concerns are to be brought together in the decision making process. Where it is intended that those offering the advice should take such concerns into account, departments should make it clear at the outset that this is the case.

ACMD suggests its regulatory advice does not consider non-scientific factors; HO suggests its drugs policy is based solely on the ACMD's scientific advice. ACMD's statutory duty requires them to provide regulatory advice to Government. Such regulatory advice can not be based solely on scientific evidence of harm - a judgement must be made about what form of regulation constitutes a response proportionate to risk. Risk assessments guide comparisons of regulatory options and these take into account many non-scientific factors including the public's risk perception or risk tolerance and european or international law. Government risk and regulatory guidance do not seem to be followed by ACMD and HO. HO do not explain how these non-scientific factors are brought together if ACMD do not consider them.

21. When asking experts to identify policy options or to comment on policy options prepared by others, departments should respect the line between the responsibility of experts to provide advice, and the responsibility of departments for any subsequent policy decisions based on that advice.

Following United Nations (INCB) criticism, HO justified cannabis reclassification by saying it was based on scientific advice from ACMD. Many other Government statements indicated the reason was to refocus police resources on more harmful illegal drugs. ACMD had recommended cannabis reclassication more than 20 years before.

Open and transparent procedures
22. Departments should ensure their procedures for obtaining advice are open and transparent. The evidence upon which the advice is based should be published. The analysis and judgement which went into it, and any important omissions in the data, should be clearly documented and identified as such. Any claims for material to be protected, e.g. on grounds of the commercial confidentiality of the information concerned should be rigorously tested.

ACMD and HO provide no explanation of the analysis, judgement and omissions behind their advice and policy. Why omit traditional drugs? What level of harmfulness is judged unacceptable, justifying prohibition? Should this level of harm be different for traditional and non-traditional drugs - if so why?

23. Departments should ensure that data relating to the issue are made available as early as possible to the scientific community, and more widely to enable a wide range of research groups to tackle the issue and to provide a check on the advice going to government. This will be particularly important, for example, where the advice will rely on research which has not been peer reviewed, or which has not been previously published.

HO have proposed the prohibition of magic mushrooms though the Regulatory Impact Assessment indicates no scientific evidence of actual harmfulness of magic mushrooms, merely 'concerns' about harm.

Risk assessment
24. In practice, deliberations on scientific advice frequently involve a risk assessment of one type or another, and scientific advice is often a contribution to a risk assessment. The Government has confirmed (3) that it will assess, manage and communicate risk as part of the policy-making process, and is committed to the better promotion, co-ordination and implementation of risk best practice. The Interdepartmental Liaison Group on Risk Assessment (ILGRA), chaired by HSE, develops policy on, and promotes the practical application of risk assessment and risk management. Separate guidance published by HSE is listed in the Annex.

ACMD and HO do not appear to follow any Government guidance on risk assessment or risk management.

Handling of scientific advice by departments
26. Departments are individually responsible for the handling of advice commissioned by them, including its public presentation. In line with the Government's Code of Practice on Access to Government Information, there should be a presumption at every stage towards openness in explaining the interpretation of scientific advice, which may mean going further than the minimum obligations. Departments should aim to publish widely the scientific advice and all the relevant papers, so those outside can satisfy themselves about the process by which the advice was formulated, and that the conclusions are correctly drawn.

HO have provided inaccurate and misleading replies concerning the reason for traditional drugs being excluded from the Misuse of Drugs Act. ACMD have not explained why they not identify and refer to alcohol and tobacco as drugs in their reports; they have not explained their risk assessment and regulatory advice methodology. (see personal correspondence for details)

27. It is important that sufficient early thought is given to presenting the issues, uncertainties and policy options to the public so that departments are perceived as open, well prepared and consistent with one another and with the scientific advice. The difficulties associated with presenting uncertain or conflicting conclusions should not be underestimated.

The Department for Education and Skills has a statutory duty to teach children that medicines as well as alcohol and tobacco are drugs. ACMD and HO do not identify and refer to alcohol and tobacco as drugs, without explanation. The Government's drug education website says "drugs are illegal" but then says alcohol and nicotine are harmful drugs.

29. Early communication with key interest groups may be appropriate. Consideration should also be given to providing early warning of significant policy announcements to other governments and international organisations, where there are likely to be implications for other countries. Where possible, scientists from such countries or organisations should be involved in the process of consultation and advice.

When considering the prohibition of magic mushrooms under the MDA ACMD and HO should consult with UN, Dutch government and international researchers. UN says magic mushrooms are not included in UN drug conventions; Dutch government's risk assessment of magic mushrooms and Heffter Institute magic mushroom study concluded that consumer risks were low. No consultation with legitimate consumers and traders has occured.

Implementation and review
30. Where it has not been practicable to follow the advice in this note, this should be made clear, together with an explanation of the reasons, when submitting relevant issues to Ministers.
31. The Government's Ministerial Science Group, MSG, supported by the committee of chief scientific advisers, CSAC, will keep under review departmental S&T strategies, and departments' procedures for early anticipation and identification of issues for which scientific research or advice will be needed. OST will keep emerging transdepartmental issues under review.
32. Departments should assess systematically how well these Guidelines have been assimilated into their departmental practice; how successful they have been in raising awareness of the principles contained herein; and the adequacy of their arrangements for monitoring how well policy makers apply them. OST will monitor implementation of the principles across departments, and report annually to the Ministerial Science Group. These reports will be published.

Annex - useful references

Code of Practice on Written Consultation, Cabinet Office
Professional Policy Making for the Twenty-First Century, Cabinet Office, September 1999
Modernising Government White Paper, Cabinet Office, March 1999
Going Public: An Introduction to Communicating Science, Engineering and Technology, DTI Publications, 1999
Reducing Risks, Protecting People, HSE Books, 1998
Risk Communication: A Guide To Regulatory Practice, ILGRA, 1998
Risk Assessment and Risk Management: Improving Policy and Practice Within Government Departments, 2nd Report of the Interdepartmental Liaison Group on Risk Assessment, HSE Books, 1998
Code of Practice on Access to Government Information: Guidance on Interpretation (Second Edition), Cabinet Office (OPS), 1997
Code of Practice on Access to Government Information (Second Edition), Cabinet Office (OPS), 1997
Guidance On Guidance, Cabinet Office, February 1996
The Setting of Safety Standards, A Report by An Interdepartmental Group and External Advisers, HM Treasury, June 1996
Regulation in the Balance, HMSO 1996
On the State of the Public Health 1995, HMSO, 1996
Communicating About Risk to Public Health: Pointers To Good Practice, Dept. of Health, 1998 www.doh.gov.uk/pointers.htm
Science and Society, House of Lords S&T Committee Third Report, HMSO, 2000
Nolan Committee First Report on Standards In Public Life, Cabinet Office (OPS), May 1995

Footnotes
1. In this document references to 'departments' should be taken to include departments and their agencies.
2. Disciplines covered include medicine, dentistry and all allied subjects; engineering and technology; agriculture, fisheries, forestry and vetinary science; biological, environmental, mathematical and physical sciences; psychology, geography, economics and social studies; and humanities.
3. White Paper Modernising Government