Department of Health
MEDICINES CONTROL AGENCY
Market Towers 1 Nine Elms Lane London SW8 5NQ
Telephone 0171-273 0600
Facsimile 0171- 273 0737	.
	11 November 1998

Dear Mr Medawar,

OG 98/59: CHARLES MEDAWAR: INTERNAL REVIEW OF REFUSAL TO PROVIDE INFORMATION

I am writing further to my letter of 14 October.

Dr Munro has completed the review you requested on 29 September of the MCA's refusal to 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 CSM on 26 March 1998 on SSRIs. I enclose a copy of his report.

Whilst Dr Munro found that it could be argued that non-disclosure of the information is defensible, he has concluded that the Agency should release either documents with necessary deletions or a suitable summary, without harming the frankness and candour of the Agency's consultation with the CSM or the efficient conduct of the Agency's operations.

We needed a little time to consider his findings and conclusions before advising you what we now propose to do. First, I have accepted Dr Munro's recommendation. I have asked MCA staff to conduct a detailed scrutiny of the relevant document(s) and to exclude confidential information. Having done so, the Agency will then determine what, if any, information might be released and whether it can do so best by providing an edited version of the document itself or preparing a summary. I intend that we will complete this work by 23 November.

Second, Dr Munro's report has led me to review my previous decision of 11 September 1998 in so far as it relates to those aspects of your requests where I refused you information about CSM. We now plan to review all the relevant requests relating to this decision to reconsider what, if any, further information or documents can be released. Again, our target date for completion is 23 November. I will let you know the outcome as soon as I can.

I have concluded that we should do this on the grounds that we may have given a rather narrow interpretation on the question of non-disclosure of past confidential information about CSM and that there may be information which can nonetheless be released within the terms of the Code of Practice.

The Office of the Parliamentary Commissioner for Administration (OPCA) has informed us that it is currently reviewing the complaint lodged on your behalf by Richard Shepherd MP about the Agency's handling of your various requests referred to in para. 5 above (your letter of 3 August to me refers). I am therefore sending a copy of this letter to the OPCA.

We are considering how we can improve our procedures for handling similar requests in future. We shall also take account of the findings and conclusions which the OPCA may make.

Introduction  Following a refusal to accede to a request from Mr Medawar to provide information concerning the consultation which the Agency conducted with the Committee on Safety of Medicines (CSM) in relation to SSRI's he requested the Agency review its decision in accordance with its procedures.

Circumstances leading to the Complaint:  In a letter responding to Mr Medawar the Agency stated that it was not prepared to release any documentation or record of its consultations with the CSM on the 26th of March regarding SSRIs. Subsequently Mr Medawar asked in a letter of the 29th of September that the Agency review its decision not to provide a positive response to his original question viz:

"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 CSM on the 26th of March 1998?"

Review Process  I have conducted the review using the appropriate Standard Operating Procedure (SOP G.2.97 and G.3.97), the Open Government Code of Practice an Access to Government Information, Second Edition (1997) and the Department of Health Internal Review Guidelines.

Conclusion   In the Code government has only committed itself to releasing information and not any particular document. Therefore the Agency may refuse to provide a copy of the verbatim record with or without deletions. However I believe the request is for whatever level of information the Agency finds itself able to release. In this instance, while it can be argued that non disclosure is defensible under exemptions 2 and 7b of the Code I believe the Agency should release either documents with necessary deletions or a suitable summary, without harming the frankness and candour of its consultations with the CSM or the efficient conduct of the Agency's operations.

Gordon Munro

2nd November 1998

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