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Dr June Raine, Director
Post-Licensing Division
Medicines Control Agency
Market Towers, 1 Nine Elms Lane
London SW8 5NQ

20 January 2003

       Dear Dr Raine,

Request for a review relating to a complaint

Thank you for your undated letter (Ref 02/49) received 18th January. I am now writing to pursue the complaint first made in my letter of 25 November 2002. Your reply did not make clear if I should do so by first requesting an internal review of the decision to exclude me from the meeting on of 21 November on the grounds "he is not a scientist," but I assume this is the case. If not, please let me know.

The complaint will allege that injustice has been caused by maladministration, relating to unfairness, bias or prejudice on the part of the MCA. In order to pursue it, I’m afraid I need some further information, though it should be easy to provide and I hope you will feel able to do so without the customary delay.

1. In your letter (point 21), you refused to disclose papers and minutes from that meeting, citing Exemption 10 of the Code Of Practice. As the CSM is not subject to the Code of Practice, nor under the jurisdiction of the Parliamentary Commissioner for Administration, the conduct of this meeting is clearly an Agency concern. Please would you let me know what Agency policies and procedures relate to the disclosure of possible conflicts of interest when impartial advice is sought from experts who have direct personal interests in the matters under discussion on such occasions?

2. At the meeting on 21 November, the Chairman invited those attending to declare any possible conflicts they might have had in relation to the matters being discussed. Please will you provide a copy of all relevant portions of the minutes of that meeting relating to disclosure of possible conflicts of interest, including details of any action the Chair took to ensure no conflicts arose?

3. If it is not clear from the above, please would you explain the basis on which it was felt appropriate that two of the three CSM scientific experts attending, Dr Donaghy and Professor Nutt, should be invited to discuss matters primarily relating to the regulation of paroxetine (Seroxat) when both are shareholders in GlaxoSmithKline, whose leading product this is? Unless covered in (2) above, please would you also provide a copy of the declaration made by the third CSM scientific expert, Professor Cunningham Owens, as it is not on the MCA/CSM website; also a copy of any declaration made by Dr David Baldwin.

I expect to come back to you at a later date on other points in your letter that are not central to this complaint.

Yours sincerely,
Charles Medawar


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