Dear Mr. Shepherd,

I refer to the letter and enclosures of 7 October from your secretary about the complaint made by Mr Medawar against the Medicines Control Agency, an Executive Agency of the Department of Health.

It appears to me that the complaint is one the Ombudsman can investigate. We have therefore prepared a summary of the complaint, which I enclose, and have, as the law requires, sent it to the Permanent Secretary of the Department of Health for his comments. Subject to those comments, we aim to complete the formal investigation and send you the report as soon as we can.

The Investigating Office responsible for the case will be Mrs Barbara Batchelor. tel: 0171-217 4084

For the present we are keeping the papers which you sent.

Attachment

1. Mr Medawar complains that the Medicines Control Agency (MCA) refused to supply him with information which should have been made available to him under the Code of Practice on Access to Government Information (the Code). He also complains that the agency took more than 20 working days to reply to his request. The following account is given:

2. On 12 March 1998 Mr Medawar wrote to the Chairman of the Committee on Safety of Medicines (CSM), an advisory committee which provides independent expert advice to the MCA, to ask under the terms of the Code:

i) on how many occasions in meetings of the CSM in 1991 and 1997 was there recorded in the minutes or elsewhere a formal vote on any matter directly connected with the licensing of any particular drug;

(ii) any instance when a member absented him/herself from the room to avoid a possible conflict of interest;

(iii) the names of CSM members who have declared interests at meetings giving dates, names of relevant products and companies, details of the interest declared and whether the member took part in the proceedings;

(iv) copies of the full entries made from 1987 to 12 March 1998 relating to any personal specific interests disclosed during CSM meetings when the product under discussion was fluvoxamine, fluoxetine, sertraline, paroxetine, venlafaxine, citalopram or nefazodone;

(v) copies of the full entries made relating to any personal specific interests disclosed during the last five CSM meetings for any relevant product.

3. On 20 March Mr Medawar wrote to the CSM asking for copies of the minutes of all CSM meetings, including all meetings of its sub-committees, held during 1998 and for a list of the scheduled dates and times for CSM (and sub-committee) meetings to be held during the remainder of the year.

4. On 26 March MCA acknowledged both requests for information. They said that they were being handled under the Code and that the CSM secretary would reply as soon as possible. On 8 May the chairman of the CSM wrote to Mr Medawar and said that, following discussions at their last meeting, members of the committee had decided that he should not be provided with the information he sought. If he wished to take the matter further he should write to the MCA.

5. On 14 May Mr Medawar replied to the chairman asking whether CSM were able to handle Code requests and, if so, why he had not been told why his requests for information had been refused. After further exchanges of correspondence the CSM chairman wrote to Mr Medawar on 1 July advising him to continue the correspondence through the MCA and on 3 July he wrote again to say that disclosure of the Committee's papers were determined by section 118 of the Medicines Act 1968 and were therefore not within the ambit of the Code. Once again he advised Mr Medawar to consider requesting the information he sought from the MCA.

6. On 10 July Mr Medawar faxed the MCA to ask when he could expect replies to his outstanding requests for information, pointing out that so far he had been waiting between 75 and 90 working days . After another exchange of correspondence MCA wrote to Mr Medawar on 23 July enclosing the dates of CSM meetings for 1998 and setting out the background to MCA's consideration of his outstanding requests. On 11 September MCA wrote again replying to the outstanding points. From anonymised and aggregated data from their records, MCA answered requests (i) and (ii). They refused to provide the information requested in questions (iii), (iv) and (v) and cited Exemptions 2 and 13 of the Code in support of their decision. On similar grounds, MCA refused to supply copies of the minutes of CSM committee and sub-Committee meetings.

7. Mr Medawar is aggrieved that CSM, having refused to provide him with the information he sought, directed him to put his requests to the MCA who, in turn, withheld much of the information from him. He seeks full disclosure.

8. The following references have been given:

OG 98/18,23 etc
MDR/MM
OG98/44

19 October 1998

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