Department of Health
MEDICINES CONTROL AGENCY
Market Towers 1 Nine Elms Lane London SW8 5NQ
Telephone 0171-273 0600
Facsimile 0171- 273 0737	.
	23 July 1999

Dear Mr Medawar,

Thank you for your letters of 25 June to me and of 22 June to Anne Thyer.

You have correctly identified two errors in the documentation sent last month. The original redacted transcript of the minutes we sent last December for the meeting of 26 March 1998 correctly stated that one member declared a personal non-specific interest and left the room. I regret that we overlooked this when checking the final documentation to send you last month. I enclose an amended copy of Appendix 1 to Mrs Thyer's letter of 18 June. The number of occasions when a member declared a personal specific interest in relation to SSRI products for the period mentioned was therefore five and not six.

The table also corrects the spelling of Elatine which you queried in your letter of 22 June to Mrs Thyer. You suggest these errors indicates serious limitations with preparing summary texts as opposed to issuing redacted documents. I appreciate your point that there may be less chance of an error with the latter although either version needs to be checked for accuracy. We have procedures in place to seek to ensure that similar errors do not occur in future.

You asked about the status of the CSM and its Code of Practice. As set out in my letter of 8 September 1998, the CSM (along with other Medicines Act advisory bodies) is an advisory non-departmental public body (ANDPB) as opposed to an NDPB. The CSM also has a further executive role in promoting the collection and investigation of reports of suspected adverse drug reactions. The annual report gives full details of the Code of Practice which is followed by all the advisory bodies. I sent you a copy of the 1997 report with my letter of 8 September 1998. This information has been published in annual reports since 1987 and the Medicines Commission introduced rules regarding declarations of interests and defined these as far back as July 1979. We have reviewed the current Code against the Model Code of Practice for Board Members of Advisory Non-Departmental Bodies (prepared by the Cabinet Office in 1998) and we consider it to be fully consistent.

You asked for an internal review of Anne Thyer's decision not to provide the information requested in your letters of 11 June to me and to Dr Jones. I do not consider that an internal review would be the correct approach. I take the view that the information you seek is integral to the complaint which the Ombudsman is currently investigating and which I would expect his report in due course to cover. We will, of course, review the action we have taken in meeting your requests for information when the Ombudsman has finalised his report and in the light of any recommendations he may make.

I am sending a copy of this letter and enclosure to Mr John Colmans at OPCA.

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	List of correspondence with MCA/CSM