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Friday, May 19, 2006

Sir Alasdair Breckenridge - Playing the Stock Market?

Social Audit Ltd
P.O. Box 111 London NW1 8XE
Telephone/Fax: 020 7586 7771

Professor Sir Alasdair Breckenridge CBE, Chairman
Medicines and Healthcare products Regulatory Agency
Market Towers, 1 Nine Elms Lane
London SW8 5NQ
26 April 2005

Dear Sir Alasdair,

Following my letter of 14 April, I am writing to make an FOIA request to try to clarify the position you outlined in your letter of 12 April:

1. Did you disclose in writing your recreational interest in the stockmarket, and the steps you took to avoid possible conflicts of interest, to colleagues on the Sub-Committee on Pharmacovigilance, Committee on Safety of Medicines, Medicines Commission, Department of Health, European Medicines Evaluation Agency and the MCA and MHRA, and was your interest made clear to those centrally involved in your appointment as Chairman of [a] the CSM; and [b] the MHRA? If so, please provide a copy of any declaration(s), indicating the dates on which they were made.

2. Whether or not your interest was declared in any written statement, please would you indicate whether and how you communicated your interest to any or all of the above-mentioned colleagues in any other way.

3. What steps, if any, had the MHRA taken, prior to my initial enquiry, to satisfy itself of the adequacy of the arrangements you made to avoid possible conflicts of interest and, in particular: [a] whether you gave instructions to your stockbroker in writing and, if so, what they were? [b] whether instructions to your stockbroker made clear what "associated industries" were prohibited as investments, and specifically which companies associated with the pharmaceutical sector were excluded? [c] whether the instructions you gave to your stockbroker were in any way modified following your appointment as [i] Chairman of the CSM; and [ii] Chairman of the MHRA? [d] whether and to what extent your investment portfolio reflected your own recommendations to your stockbroker about investments in specific companies that should be bought or sold? [e] whether and to what extent members of your family held, bought or sold stock in their own name(s)? and [f] whether any family investments were held through nominees?

I have already made clear that the issue here is not to do with personal probity; it is about Agency and Departmental policies and perceived fitness for position, the man for the job. These questions arise mainly because I��m trying to understand more about the culture and organisation of drug regulation, and the legitimacy of the Agency��s claim to deserve public confidence. I am particularly anxious to know if your colleagues knew of your interest and regarded it as unexceptional. I have also wondered what standards might apply to other people centrally involved in drug regulation:

4. Would the Agency consider it appropriate for other MHRA staff, with similar interests in stockmarket investment, to disclose this and explain the steps taken to avoid possible conflicts?

5. Would such disclosure be considered appropriate for anyone now applying for appointment to the new Commission on Human Medicines, given that "the new appointees will be required to sign a form declaring their interest" and that the guiding principle on appointments is that, "there are robust arrangements in place to manage any interests that are declared"?
These issues seem all the more relevant, given the Parliamentary Health Committee��s recent conclusions on the MHRA (para 376 refers), also the circumstances in which the abortive November 2003 ��Intensive Review�� of the safety of SSRI antidepressants was set up, at the time you were chairman of the CSM. Given the steps you took to avoid investment in pharmaceutical and associated companies, it seems that much harder to understand the appointment to that review of two CSM members who were shareholders in the main company under investigation.

I look forward to hearing from you.

Yours sincerely,
Charles Medawar

The reply:

Medicines and Healthcare products Regulatory Agency
Market Towers1 Nine Elms Lane, London SW8 5NQ

Mr Charles MedawarSocial Audit LtdP.O. Box 111London NW1 8XG
General enquiriesTelephone 020 7273 0000 Fax 020 7273 0353E-mail
Direct line: 020 7084 2600Direct fax: 020 7084 2737

20th May 2005

Dear Mr Medawar,

I am writing on behalf of the Agency in reply to your FOIA request of 25 April 2005, addressed to Sir Alasdair Breckenridge.

You ask whether Sir Alasdair made known his recreational interest in the stockmarket on his appointment to the Chairmanship of the CSM and then the MHRA. The former appointment was subject to the then Code of Practice for Ministerial Appointments to Public Bodies, and while serving as Chairman on the CSM Sir Alasdair was subject to the rules relating to declarations of interest set out in the Code of Practice for Members of the Medicines Commission and Section 4 Committees and Sub-Committees. In his appointment as the Chairman of the MHRA, Sir Alasdair is subject to the Civil Service Management Code.
To take your points in turn:

1 and 2: There was no disclosure in writing by Sir Alasdair of his recreational interest in the stockmarket in relation to his appointments to the Chair of the CSM and of the MHRA. Recreational interests are not required to be disclosed unless the person believed that it could be regarded as influencing his advice.

3 and 4: MHRA took no steps to extract details on any of the areas you cite. Under the relevant Codes, the onus is on the individual Committee Chair or member, or staff member to disclose interests which he or she considers relevant. Once interests are disclosed, the Agency will advise that individual of any Agency requirements concerning the retention, disposal or management of those interests. The Agency is not required, under the relevant Codes, to investigate proactively the possibility of any interests other than those that have been declared:

5. The Code of Practice for applicants for the new Commission on Human Medicines is currently being finalised. But it is likely to specify that the Chairs and members of the CHM, the Homoeopathics Board and the new Herbal Medicines Committee must hold no direct personal interests in the pharmaceutical industry. This will apply also to the Chairs of Expert Advisory Groups. All Chairs and members of the advisory committees must declare any financial interest or other matters that could affect their impartiality, or that could reasonably be perceived as affecting their impartiality.

Yours sincerely,
Roy AlderDirector, Executive Support

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