Department of Health
MEDICINES CONTROL AGENCY
Market Towers 1 Nine Elms Lane London SW8 5NQ
TEL:  020 7273 0400
FAX:  020 7273 0675 .
4 February 2003

Dear Mr Medawar,  

Thank you for your letter of 20 January. I apologise that my letter of 16 January was undated and enclose a dated copy for your files.

You have asked whether the appropriate first step in your formal complaint about not being invited to the meeting of 21 November 2002 is to request an internal review of the decision. The terms of the Code of Practice on Access to Government Information relate to disclosure of information, and internal reviews relate to decisions not to disclose information sought. I have explained in my previous letters the reasons that you were not invited to the meeting of 21 November and I do not think that an internal review is appropriate in this instance.

I note that you consider that your exclusion from the meeting was caused by the Agency’s maladministration. The Parliamentary Commissioner for Administration investigates complaints from individuals who claim to have suffered injustice due to the maladministration of Government departments. I suggest therefore that your complaint is best directed to the Parliamentary Commissioner, Ms Ann Abraham.

You ask about the Agency’s policies and procedures relating to the disclosure of conflicts of interest. Members of the Medicines Act Advisory committees are required to follow a Code of Practice relating to declarations of interests in’the pharmaceutical industry. The Code of Practice specifies different types of interests, how they must be declared by members and indicates what action the Chairman should take in various circumstances. Both the Code and the individual details of members’ interests are published annually in the Advisory Bodies’ Reports (Medicines Act Advisory Bodies -Annual Reports for 2001 was published in July 2002). These reports are also available on the MCA’s website at www.mca.gov.uk. A copy of the Code is enclosed.

In response to your second and third questions, I attach an extract from the minutes of the meeting of 21 November 2002. Professor Nutt and Dr Donaghy left the room for the discussion on Seroxat. Professor Cunningham Owens did not declare any interests.

On a separate issue, I had understood that you were to attend the planned meeting with representatives of the Seroxat User Group last Tuesday, 28 January to discuss among other things the patient information. I am sorry that you were unable to attend. You are probably aware that due to the last minute problems experienced by some attendees from the Seroxat User Group the meeting was postponed, however we are trying to find suitable dates to reschedule, and would hope to have an opportunity to meet you then. 

Yours sincerely
DR J M RAINE,
Director, Post-Licensing Division

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EXTRACT FROM THE MINUTES OF AD HOC EXPERT MEETING ON THE SAFETY OF SSRIs THURSDAY 21 NOVEMBER 2002

3. DECLARATION OF INTERESTS

3.1 Dr Donaghy declared a personal non-specific interest in GlaxoSmithKline. Professor Nutt declared both a personal, non-specific interest and personal specific interest in GlaxoSmithKline. The Chairman stated that Professor Nutt and Dr Donaghy should leave the room for items 6 and 7 of the agenda, but could participate in items 1-5 as they applied to SSRIs as a class.

3.2 Notes received subsequently - Dr Herxheimer has no interests to declare. Dr Healy has declared personal interests in Eli Lilly, Lundbeck, Solvay , Pfizer and Smith Kline Beecham - it was not stated if these were lapsed or current and took the form of consultancies, support for symposia and conferences and as principal investigator or clinical trialist. Dr Healy also declared that he had acted as an expert witness in a number of trials involving SSRIs.

3.3 Professor Nutt also declared lapsed non-personal, specific interests in Pfizer, Lilly and Solvay and a lapsed non-personal, non-specific interest in Lundbeck. Professor Evans declared non-personal, non-specific interests in Glaxo Smith Kline and Dr Baldwin declared personal, non-specific interests in Lundbeck. These interests did not exclude participation in any part of the meeting.

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List of correspondence with MCA/CSM