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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