REQUESTS MADE UNDER THE CODE OF PRACTICE RELATING TO THE COMMITTEE ON SAFETY OF MEDICINES (OG CASES: 98/18, 23, 24, 37, 44; 99\10) PLUS LETTERS OF 11 JUNE TO DR JONES (OG 99/22) AND MR ALDER

As Mr Alder is on leave, I am writing further to his letter of 31 March and the review conducted by the Agency of your requests for information about the Committee on Safety of Medicines (CSM) which were the subject of your complaint to the Office of the Parliamentary Commissioner for Administration (OPCA).

As you will be aware from Mr Alder's letter of 12 March, the Agency has decided that the preparation of edited summaries of the minutes of the CSM and its sub-committees is the most appropriate way of providing the information you have requested. Summaries of the minutes of the meetings held up to 20 March 1998 are enclosed together with a report which lists, and further explains, the information and summary documents provided. The summaries do not contain any personal, commercial or otherwise confidential material within the terms of exemptions 2(d), 7, 13 and 14 of Part 11 of the Code of Practice on Access to Government Information (confidential communications between departments, public bodies and regulatory bodies, information which would harm the Agency's effective management and operations, and third party commercial or otherwise confidential material). Those summaries are also being posted on the CSM's website.

Please note that, in respect of the request you made for information about declarations of personal specific interests (A.3 in the attached report) the CSM Secretariat has re-examined its records and provided corrected figures. I am sorry we sent incorrect information previously.

I am also sorry that the preparation of this material has taken longer than originally expected and I apologise for that delay and for any inconvenience and frustration this may have caused.

OG 99/10: Internal review by Dr Munro

Dr Munro has completed his review of your complaint that the MCA constructively refused your request for disclosure of CSM minutes. He also considered your later request of 16 February for copies of the CSM agendas as part of his review. Dr Munro's report is attached. He has concluded that since some of the documents requested by you do not yet exist, the Agency cannot decide in advance how best to provide the information sought and is therefore justified in not meeting your request. However, for those documents which do exist, Dr Munro's recommendation is that the Agency should review what information is discloseable and decide how best to provide this, subject to any charge being met.

We have accepted Dr Munro's recommendations and have decided, in relation to past CSM meetings in 1998 and 1999, to prepare further edited summaries and to release them in a rolling programme on the CSM website (starting with the earlier 1998 meetings). There will of course, be no charge. The CSM Secretariat is completing work on the remaining CSM meetings for 1998. We expect these summaries to be available in the near future and will let you know when they are ready.

Correspondence of 11 June with Dr Jones (OG 99/22) and Mr Alder

Your most recent letters to Dr Jones and Mr Alder request a range of information which is concerned with your current complaint to the OPCA. I am not prepared to release any information or documentation relating to communications which may exist between the Ombudsman, the Permanent Secretary of the Department, this Agency and the members of the CSM arising from your complaint. My reasons are that such information or documents constitute confidential communications between departments and other public or regulatory bodies as described in exemption 2(d) of Part 11 of the Code of Practice. I am copying this letter and all enclosures to Mr John Colmans at the OPCA.

REQUESTS UNDER THE CODE OF PRACTICE RELATING TO THE COMMITTEE' ON SAFETY OF MEDICINES (OG CASES: 98/18, 23, 24, 37, 44)

This information has been disclosed. There were no formal votes in 1991, nor in 1997 at CSM meetings concerned with the licensing of a particular drug.

A.2 Instances of members absenting themselves from meetings to avoid possible conflicts of interest

As explained in the letter of 11 September, members, if they have a personal specific interest to declare in relation to a product under discussion, may simply not be present for that part of the meeting. The minutes of the meetings only record those members who have sent apologies, and not the reasons for such apologies. A member will customarily inform the Secretariat in advance if he or she will not be attending, but whether this is because of a possible conflict of interest is not recorded.

The MCA letter of 11 September advised that in 1991, there were 71 declarations of interest at meetings of the CSM of members who either left the meeting or did not take part in discussions or decisions. In 1997, there were 86 such declarations.

A.3 Personal specific interests declared in relation to

(a) SSRI products discussed since 1987; and

(b) to any "relevant product" at the last 5 CSM meetings

The MCA letter of 11 September advised that there were two occasions on which declarations of a personal specific interest were made in relation to fluoxetine, and none in relation to the other medicines referred to between 1987 and 31 July 1998.

The CSM Secretariat has re-examined its records and provided the following corrected information:

a) SSRI products discussed at CSM meetings between 1987 and 31 July 1998.

Fluoxetine (Prozac): There were six occasions on which a member declared a personal specific interest and left the room.

Appendix 1 provides an edited summary of the full entries of declarations of interests from the minutes for the first five of these occasions as this is the simplest way of providing the information.

The sixth declaration was at the meeting of 26 March 1998, and a copy of that minute has been provided with the edited MCA assessment report in Mr Alder's letter of 23 December.

In relation to other SSRI products, the record does not show any occasions on which members declared a personal specific interest.

It is important to note, as explained above, that members may decide not to attend a meeting where there is discussion of a product in which they have a personal specific interest. In addition, where CSM members declare a personal but non-specific interest, they may be asked to leave the room, to take no part in the discussion or decision or to remain only to answer any questions. The table at Appendix l gives one such example.

b) any "relevant product" at the last 5 CSM meetings

The reply of 11 September advised that there were no declarations of a personal specific interest at the five meetings of CSM held between 14 January and 11 March 1998. The CSM Secretariat has now advised that the meeting of 11 March was cancelled. The meeting prior to 14 January was held on 10 December 1997. There were no declarations of a personal specific interest at that meeting.

B LETTER OF 7 MARCH TO MR ALDER

B.1 Copies of any discussions relating to commercial confidentiality recorded in (extracts on CSM minutes over the last 5 years

Edited summaries from the minutes of the meetings of 22 July 1993 (together with a copy of a paper tabled at that meeting) and 28 November 1996 are attached as Appendix 2.

C: LETTER OF 20 MARCH TO MR WHITBREAD

C.1 Copies of CSM and sub-committee minutes edited to remove confidential information

Copies of the relevant minutes up to 20 March 1998 have been summarised and are listed and attached as Appendix 3.

C.2 Details of forthcoming CSM and sub-committee meetings.

This information was sent on 23 July 1998.

D: LETTER OF 14 MAY TO PROFESSOR RAWLINS

D.1 CSM's mandate in relation to Code requests

The information was disclosed on 8 September and has been subject to further correspondence

D.2 Extract of relevant minute of CSM's meeting, which discussed the request of 12 March

This information is at Appendix 4.

D.3 Any CSM/MCA consideration within the last 6 months (taken to mean since December 1997) of revisions to data sheet warnings about withdrawal reactions with SSR1s.

D.4 If so, whether or not CSM is satisfied with them as they stand

D.5 If not whether CSM has some substantial revision in mind

This information was disclosed in the letter of 23 December which enclosed a copy of the MCA assessment discussed by the CSM on 26 March together with the edited minutes of that meeting. The subject was also discussed at the meeting of the Sub-Committee on Pharmacovigilance on 24 February (see copy of minute now attached at Appendix 3, item 11).