|Social Audit Ltd|
|P O Box 111 London NW1 8XG|
|Telephone/Fax 44 (0) 207 586 7771|
|Head of Executive Support|
|Medicines & Healthcare products Regulatory Agency|
|Market Towers, 1 Nine Elms Lane|
|London SW8 5NQ||
8 August 2004
Im 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 dont 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.
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