|Department of Health|
|MEDICINES CONTROL AGENCY|
|Market Towers 1 Nine Elms Lane London SW8 5NQ|
|Telephone 0171-273 0600|
|Facsimile 0171- 273 0737||.|
|16 September 1999|
Dear Mr Medawar,As you may know the Ombudsman has issued his final report of his investigation into your complaint to Mr Richard Shepherd, MP. The Ombudsman made a number of recommendations and this letter is to let you know how the Agency intends to respond to those recommendations.
The Ombudsman considered that the MCA should:
(a) - release the names of MCA officials present at meetings
(b) - release the names of those CSM members who declared personal specific interests in SSRI and related products on five occasions between 1987 and 31 July 1998
(c) - release the names of those members declaring interests at the 10 meetings of CSM and its subcommittees in early 1998
(d) - release the names of products and companies discussed at the 10 meetings of CSM and its sub-committees in early 1998
On (a) the MCA have agreed to release names but will delete references to the agenda items for which individual staff members attended. That is necessary to safeguard the safety of staff (exemption 12 of the Code of Practice on Access to Government Information refers) as some may be involved, for example, in discussions of toxicology tests on animals. This is a current matter of concern to the MCA and all staff had to be reminded earlier this year of the need for care and vigilance about disclosing personal information. On (b) to (d) the Agency have also agreed to release the names of members, provided that any regulatory action associated with the agenda item at which the interest was declared, is now complete. Where regulatory action is still underway, MCA will not link the details with the individual agenda item until such action is over. In the meantime, the MCA will continue to provide aggregated statistical information about declarations of interests. Companies and products will also not be named until regulatory action is complete.
The Ombudsman also recommended that the Agency:
- release information re para 8. 1(vi) of CSM meeting on 14 January 1998
- release information re para 8.2(iii) of CSM meeting on 14 January 1998
- release information re para 7 of CPS meeting on 5 February 1998
That information, edited where necessary to withhold material where regulatory action is not complete, is now disclosed.
The Ombudsman noted two apparent inconsistencies having compared the summary minutes prepared by the Agency with the original source documents. A correction concerns a declaration of interest made by a member at the CPS meeting on 5 March 1998. The summary quoted the declaration as a personal non-specific interest when it should have been a personal specific interest. The relevant summary has been amended. However, I confirm that the date of "5 February 1998" as shown for the date of the previous CPS meeting in the summary of the 5 March 1998 meeting is correct (the original minutes for 5 March incorrectly quoted 2 October 1997 instead of 5 February 1998).
I enclose for your information a revised schedule of declared interests in SSRIs and revised summaries of the CSM and subcommittee meetings in early 1998. Summaries of the minutes of meetings of the CSM from late March 1998 onwards will be prepared and published on the CSM web-site as soon as possible. Subsequent updates of those summaries will disclose details of interests and products where the appropriate regulatory action is complete.
Once again, I repeat my apologies for the delays that have occurred in finalising your requests for information.
I am sending a copy of this reply, and enclosures, to Mr John Colmans at the Ombudsman's Office.
|Head of Executive Support|
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