Department of Health
MEDICINES CONTROL AGENCY
Market Towers 1 Nine Elms Lane London SW8 5NQ
Telephone 0171-273 0270
Facsimile 0171- 273 0293

Dear Charles,

Thank you for your letter of 28 January 1998 regarding your complaint about the Agency's refusal to disclose information concerning data submitted by SmithKline Beecham in connection with paroxetine. I apologise for the delay in responding to you but I have been anxious to ensure that full consideration was given to this case and that has taken time.

I have carefully reviewed the circumstances of this case and consider that there are no grounds to substantiate. The Agency has, in my opinion, acted correctly in refusing to disclose this material which was submitted in confidence to the Licensing Authority. This view is supported by the Code of Practice on Access to Government Information and by rules of common law (although we do not rely on the latter in this instance, since paragraphs 13 and 14 of the Code apply in this case).

Neither I nor our lawyers consider that the information you request can be disclosed under public health exemptions.

The only other way in which we could have supplied this information to you would have been with the consent of the company involved. However, as you are aware the company refused to give their consent.

I have now had an opportunity once again to read the paper by Price, Waller, Wood and Mackay in the British Journal of Clinical Pharmacology 1996, Volume 42, pp 757-763, and have seriously considered whether there are scientific grounds sufficient in your argument to warrant the Agency's requesting formally that the Journal withdraw this article. I have not found scientific grounds for taking this course of action.

This issue has been considered by other experts in the area, none of whom have shared your opinion. Furthermore, the article was submitted by the Journal to peer review prior to its publication. It is of course always open to you to formulate the scientific basis of your opinion in a fashion suitable for publication, submit it yourself for peer review, or to the Editorial of the journal in which the original article was published.

You have also asked me to take into account a recent letter sent to Dr Wood enclosing copies of correspondence between yourself and Professor M Rawlins dating back to 1987. As Professor Rawlins points out, the opinion he gives is a personal one - not made as Chairman to the Committee on Safety of Medicines and also, that data is submitted to the Licensing Authority not the CSM and it is therefore not for the CSM to consider disclosure.

In the circumstances, I consider that my staff have acted correctly and within the law in not disclosing the information which you have requested.

I trust that you will understand and accept this position. In the event that you remain dissatisfied and wish to pursue the matter further, the appropriate course would be for you to write to the Independent Complaints Adviser, Mr Norman Hale, c/o Room 2105 here at Market Towers.

Yours sincerely

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