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Mr Roy Alder, Head of Executive Support
Medicines Control Agency
Market Towers, 1 Nine Elms Lane
London SW8 5NQ 21 August 1998

Dear Mr Alder,

Thank you for your reply of 17 August to my letter of 29 June.

I agree my questions in paragraphs 2, 3 and 6 of that letter were not Code requests, but that was no reason to by-pass them. In the light of Dr Munro's findings, I was just asking if the Agency's much professed commitment to openness was any more alive than you know what. Dr Munro's report said to me that we had been elaborately messed around because Dr Jones, with apparently no justification, decided not to answer a few straightforward questions. It would have taken him a few minutes; instead he caused us to wait four months. In the absence of any explanation for what had happened, I naturally wondered about the worth of Agency policy. When you decline to comment and then suggest that I should turn to Dr Jones, if unhappy, I wonder all the more. Given the circumstances, and the possible conflict of interest, it cannot be appropriate for me to ask Dr Jones to conduct a review.

For the record, I'm not so much "unhappy" about the Agency's response, as fascinated by it. Every time I am refused sight of this or that bit of data, I also learn more about the power of inertia, and how secrecy contains it. Over and above the Code requests, bigger pictures and new thoughts and understandings are emerging. Recently, for example, I have become intrigued by the idea of secrecy as an illness (Major Secretive Disorder) or an addiction ("exemption-seeking behaviour" etc). I hesitate to make a surefire diagnosis, but I confess to dabbling with an adaptation of the DSM-IV definition of "substance dependence" - with secrecy as the substance in mind. See Attached.

Turning to your letter, I just haven't the time or energy right now to pick it all to pieces, but the reasons for refusing disclosure look desperately thin to me. In particular, the idea of "harming the conduct of international relations or affairs" is florid nonsense - for reasons the Guidance Notes explain rather well.

I shall, however, make three Code requests that should be quite straightforward, at least until your colleagues get their hands on them:

1. Please supply me with full verbatim texts of the information you identify as non-confidential under paras 5(i) and (ii) of your letter.

2. In para 11 you mention "the exception of one respondent", among those the MCA consulted, who requested confidentiality. Was this the CSM?

3. Re para 9 of your letter, please provide the fullest possible information (if necessary, deleting from the verbatim record information covered by s.118 of the Medicines Act) about the MCA consultation with the Committee on Safety of Medicines on 26 March 1998.

I request the latter on the grounds that you have given no evidence that confidential information is involved, nor any indication that harm might be done if the information requested were put in the public domain. The issue here is whether the CSM's right to ignore the spirit of the Code outweighs some greater public interest. Your letter gave no indication that you considered the public interest in disclosure in this case, nor why you imagine it to be outweighed by some threat of a petulant response. See Introduction to Guidance Notes on the Code. More specifically, I reject the MCA's claim to an exemption under II(2) in the light of the exclusion relating to "Expert advice" in the Guidance Notes at (II) 2.11.

"There is less need for confidentiality in respect of advice from expert advisory committees, especially where the members of committees are not civil servants, where the availability of the assessment will enhance public debate and understanding of an issue, and it is important that there should be opportunities for scientific assessment and analysis to be contested or made available for peer group review"

This couldn't be much plainer, so I hope you will feel able to supply me with this information within 20 working days. If not, I would appreciate it if the MCA's refusal to disclose was in terms which would permit me to immediately seek a referral to the Ombudsman.

Thank you for your attention. I look forward to hearing from you.

Yours sincerely,
Charles Medawar



Contents page
List of correspondence with MCA/CSM


1. Introduction, Code of Practice on Access to Government Information: Guidance on interpretation (Second edition, 1997).

"... the presumption remains that information should be disclosed unless the harm likely to arise from disclosure would outweigh the public interest in making the information available … The public interest in disclosure is particularly strong where the information in question would assist public understanding of an issue subject to current national debate, or improve the transparency and accountability of a particular function of government".



2. Re: Code Exemption 1(b), "Information whose disclosure would harm the conduct on international relations or affairs."

"The purpose of the exemption is to protection information which would impair the effectiveness of the conduct of international relations. The harm or risk of harm which arises will need to be explained. It includes:

  • disclosure which would impede negotiations, for example by revealing a negotiating or fall-back position, or weakening the government's bargaining position;
  • disclosure which would undermine frankness and candour in diplomatic communication; for example the appraisal of personalities or political situations; and
  • disclosure which would impair confidential communications and candour between governments or international bodies.

The Foreign and Commonwealth Office should be consulted in any cases of doubt

The exemption is consistent with the very high levels of transparency and information about policy, and should not, in particular, be interpreted in a way which undermines the agreed policy of the European Union to secure greater openness about the workings of Community institutions and preparation of policies."  



3. Re: secrecy as substance etc. After "Criteria for Substance Dependence", Diagnostic & Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), Washington DC, American Psychiatric Association, 1994, 185-189.

"A maladaptive pattern of substance use, leading to clinically significant impairment or distress, as manifested by three (or more) of the following occurring at any time in the same 12-month period ….":

1... a need for markedly increased amounts of the substance to achieve desired effect (tolerance);

2… the development of a substance-specific syndrome due to the cessation of (or reduction in) substance use that has been heavy and prolonged (withdrawal);

3… the substance is often taken in larger amounts (Code noncompliance) or over a longer period than was intended (notwithstanding regrets);

4… there are unsuccessful efforts to cut down or control substance use;

5… a great deal of time is spent in activities necessary to sustain substance use;

6… important normal activities are given up or reduced because of substance use; and

7… the substance use is continued despite knowledge of having a persistent or recurrent problem that is likely to have been caused or exacerbated by the substance"



Contents page
List of correspondence with MCA/CSM