Matters arising in connection with complaint about the Medicines Control Agency, made under the Code of Practice on Access to Government Information, and referred to the Ombudsman by Richard Shepherd MP, 10 July 2000

The Office of the Parliamentary Commissioner for Information informed Richard Shepherd MP (26 July 2000) that the Ombudsman had decided to investigate in this case, but would not be able to help with certain aspects of the complaint.

1. The Ombudsman emphasised that the Medicines Control Agency (MCA) is not required under the Code to release any specific document, as opposed to information derived from it. The Ombudsman could not therefore help us to obtain the discussion paper on Direct To Consumer Advertising, per se.

That point is taken, but we have requested that the Ombudsman considers taking a view on how the MCA exercised its discretion in this particular case. Did it seem to fulfil or frustrate the MCA's commitment to the main Aim of the Code: "to improve policy making and the democratic process by extending access to the facts and analyses which provide the basis for the consideration of proposed policy"?

In this case, we argue that it was in the public interest for the MCA to disclose as much as possible, as fast as possible. Our complaint is that it did not, and that the MCA has routinely disclosed less and later than they might. Specifically, we have suggested that some sort of 'redaction mentality' may have had a lot to do with the delay and frustration we are complaining about. If the person at the MCA who has to deal with a Code request feels he/she is going to have to carefully rewrite or précis a document, they will naturally be more reluctant to disclose and take longer to do so. So it seems important to know if the MCA might have done better in this case by resolving to provide a facsimile version with sensitive bits blacked or whited out. Our view on this is coloured by pretty reliable information that there is, in fact, little or nothing in the discussion paper that needs to be kept confidential. We have now written to ask if the Medicines Commissioners themselves took any view on this.

2. The Ombudsman explained there was no basis for investigation of any complaint unless a request for information had been refused, and then been subject to an internal MCA review. Therefore the Ombudsman could not investigate our complaint that the MCA had refused to identify the authors of the discussion paper on DTCA

We did not specifically ask the MCA to disclose the names of the authors of the discussion paper. We made a specific request relating to "any minuted discussion in a meeting of the Medicines Commission", and this was supplied with the names of the authors deleted. We have asked the Ombudsman to accept that the request for disclosure was implicit and that the MCA recognised it by specifying the grounds on which disclosure was refused (Exemption 12). We also asked the Ombudsman to take into account that we had been gently misled to believe (MCA letter of 20 April) that MCA staff had prepared the paper, when it was in fact jointly produced by members of the MCA Board and the Medicines Commission. We have now written formally to the MCA to request an internal review of this refusal, on the grounds that the public interest would outweigh any harm done by disclosure.

3. For the same reason, the Ombudsman was unable to consider other instances in which we felt we had ground for complaint about delay and refusals to disclose. The Ombudsman could not consider other cases, unless there had been refusals to disclose followed by an internal MCA review.

We appreciate the Ombudsman cannot investigate these other cases, but would want consideration to be given to what we see as a pattern in the MCA's response to requests for information. On every occasion Social Audit has requested review of a refusal, it has resulted in greater disclosure. We suggest this is relevant as context: the evidence points to a pattern of grudging disclosure, especially inappropriate in the case of the discussion paper on DTCA. We refer to the following, which we believe to be established as matters of fact - but would withdraw any that the MCA did not accept as such.

[a] Letter from MCA's Mr Alder (26 June 1998), with report of review by Dr Munro, substantially upholds complaint (11 February 1998) about Dr Jones refusal to disclose (6 February 1998) basic information about the MCA's enquiries about risk of dependence on antidepressant drugs.

[b] Letter from MCA's Mr Alder (11 November 1998), with report of review by Dr Munro, substantially upholds complaint (29 September 1998) about MCA refusal to disclose (8 September 1998) basic information about the MCA's consultation on SSRI antidepressant drugs with the Committee on Safety of Medicines

[c] Letters from Mr Alder (9 December and 23 December 1998) detail results of MCA's review, in response to Dr Munro's recommendations, making various commitments to disclose information previously refused.

[d] Letter from MCA's Mrs Thyer (18 June 1999), responding to recommendations made in Dr Munro's review of 29 April 1999, leads to disclosure of edited minutes of certain CSM meetings.

[e] Letter from Mr Alder (16 September 1999) responding to review by The Parliamentary Ombudsman (9 September 1999) leads to further disclosure of edited minutes of certain CSM meetings.

[f] Letter from Mr Alder (31 March 2000) encloses review by Dr Pugh, finding that the MCA's response to questions relating to the dosage of fluoxetine was "factually correct" and "did not compromise the Code", but that "a more complete, helpful and positive response could have been provided …"

[g] Letter from Mr Alder (29 June 2000) enclosing Dr Munro's review dated 15 June 2000, recommending further disclosure about the MCA's views of DTCA (documentation supplied).

[h] The letter from Social Audit to the MCA's Mr Bagwell (29 June 2000) made a formal complaint about delays and failure to respond to requests for information about the MCA's control of drug advertising. Two further letters from Social Audit (25 July and 31 July) crossed in the post with a letter from Mr Bagwell dated 21 July 2000 and a substantive response from Mrs Thyer (28 July). The Ombudsman has now been asked to consider this correspondence as evidence in support of our allegation of persistent and abusive delay.

4. The PCA set out its Summary of the present complaint (Case No A 16/01) which has been forwarded for consideration and comment by the Permanent Secretary at the Department of Health.

We had no comment on this, other than to say that we hoped that the resolution of this complaint might suggest the basis for some more general improvement in communication between the parties involved. We would be pleased if the Permanent Secretary's response were to come to this point because, if the complaint is reviewed without regard to context, problems would seem likely to continue in future.


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List of correspondence with MCA/CSM