Department of Health
MEDICINES CONTROL AGENCY
Market Towers 1 Nine Elms Lane London SW8 5NQ
Telephone 0171-273 0729
Facsimile 0171- 273 0286	.
	Our ref : OG 02/50
	9 January 2003

Dear Mr Medawar,

I am replying to your letter of 24 December. I am sorry that you considered my letter of 17 December one of "ritual regret". Paragraphs 61 to 65 of the Guidance on Interpretation (second edition) to The Code of Practice on Access to Government Information gives guidance on interpreting paragraph 5 of the Code, which, as you will be aware, concerns the 20 day target for response to a request for information. Paragraph 5 is clear that the 20 day target relates to "simple requests for information", and states that the "target may need to be extended when significant research or collation of material is required." Paragraph 63 of the Guidance notes that "Simple is not defined, but should include most requests that do not require extended search or consideration ". Paragraph 64 says, "No fixed extended period for responding to requests that are not simple is set, this will depend on the amount of work to be done."

Your letter of 28 November to Mr Alder contained not one but eighteen separate requests for information under the Code This information is not held in one single, easily accessible, point within the Agency, and some of your requests (for example those concerning your previous letters to Dr Raine) refer to requests that you have already made, To provide full answers requires liaison and consultation within the Agency. We believe, therefore, that the requests contained in your letter of the 28^th November can not be reasonably considered to be "simple’, and, that the Agency is therefore justified in taking in excess of the recommended 20 working days to respond to them.

You say in you letter of 24 December that you "did not ask the Agency to consider something, I asked for information I am entitled to get." It is MCA policy that all requests for information are considered under the Code. It may be the case, for instance, that such consideration will lead to the conclusion that information previously believed to be exempt is, in fact, releasable, or has become releasable with the passage of time.

You make two new requests for information in your letter of 24th December. The first relates to the existence, or otherwise, of a "database or some other collection of data from which it would have been possible to extrapolate, in less than four person hours … [a] the number of occasions in the previous year on which the MCA had made representations about possible breaches of the medicines advertising regulations to licence holders, indicating in each case [b] the identity of the manufacturer/product and [c] the nature of the complaint." You also asked how long, in the absence of such a database, it would take the Agency to locate and collate such information. The MCA has no such database or other collection of data. I have established from relevant colleagues that it would take approximately three hours to extract figures for one year You may be interested to know that the Agency’s Annual Report for the year 2001/2002 included the following, under the heading "Advertising", "The Agency identified a total of 131 potential breaches of the legislation, leading to the amendment or withdrawal of the advertising material." (page 23), The total of representations made would have been greater than this number, as not all representations would have resulted in further action.

In respect of [b] and [c], I refer you to Mr Alder’s letter of 11 October 2000, replying to your request for similar information of 30 January 2000 In his letter Mr Alder wrote "I consider that the information you requested concerning the identity of the manufacturer/ product, and the nature of the complaint should be withheld under Exemption 4c of the Code of Practice on Access to Government Information." It remains the case that the Agency believes that Exemption 4c applies, and therefore I am unable to provide details of the identity of manufacturer/product or the nature of the complaint.

We hope to be able to respond fully to your letter of 28 November soon. If you are dissatisfied with the way in which the Agency has dealt with this request to date, or with your letter of 24 December, under the review system that you are familiar with, you have recourse to the Parliamentary Commissioner for Administration.

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