Social Audit   Ltd
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Roy Alder
Head of  Executive Support
Medicines & Healthcare products Regulatory Agency
Market Towers, 1 Nine Elms Lane
London SW8 5NQ

8 August 2004

        Dear Mr Alder,

I’m preparing a talk for 8 September on: "Drug information - what should who know and who is to tell it?" This will be at a conference organised under the Dutch presidency of the EU on, "Shaping the EU Health Community: Balancing Health, Social Development and Internal Market".

I should like to be able to report at this conference that the implementation of the Freedom on Information Act, and the repeal of s. 118 of the Medicines Act, is going to make some worthwhile contribution to transparency, even clinical practice – starting in 2005. However, I do not have evidence to override my feeling that there is nothing much to look forward to: if there were, I would have expected the MHRA to broadcast it.

Another concern relates to the definition of "commercial confidentiality" that the MHRA will rely on. Does such a formal definition yet exist and, if so, please could you provide it, and/or all other key documentation that would guide Agency staff and other interested parties, including product license holders, on its meaning?

For all this, I confess that I don’t yet know enough about the detail of the changes due next year, so that my mind is somewhat open. If there is anything that you and/or your MHRA colleagues could tell me about the transparency benefits that might accrue from 2005, I would welcome it. Please feel free to enthuse me.

Yours sincerely,

Yours sincerely,
Charles Medawar


List of correspondence with MCA/CSM