|Social Audit Ltd|
|P O Box 111 London NW1 8XG|
|Telephone/Fax 44 (0)171 586 7771|
|Mr Roy Alder, Head of Executive Support|
|Medicines Control Agency|
|Market Towers, 1 Nine Elms Lane|
|London SW8 5NQ||7 March 1998|
Dear Mr. Alder,
I am writing with a number of queries arising from the MCA's submission of 9th February to the Select Committee on Public Administration, and please will you treat them as formal requests under the Code. I am also sending a copy of this letter to the Clerk of the Committee, if only to illustrate what the MCA sometimes has to put up with in dealing with Code requests.
1. You told the Committee that: "The MCA already releases a great deal of information to the public, including information on adverse drug reactions." You specifically represented this as an illustration of the Agency's policy "to make as much information available as possible within the terms of the Code of Practice on Access to Government Information." Would you not accept that that this fundamental change of policy was the direct result of a series of complaints and requests for information under the Code, made by Social Audit and Health Which? and that the MCA went to great lengths to resist them?
To recap: our initial request was made in January 1996, but it took until February 1997 for you to confirm that "We are changing our practice and our internal standard operating procedures accordingly, with immediate effect." The thick correspondence between us confirms it was a real slog from start to finish. It seems neither fair nor straightforward to suggest this gives any real evidence of a policy "to make as much information available as possible within the terms of the Code " The outcome certainly represents improvement, but the whole process was clearly driven by a need for damage limitation, not by any underlying determination to disclose.
2. The problems that we and others have always faced with the MCA/CSM, when seeking disclosure, have been thickly underlined by the CSM Chairman's recent and remarkable confirmation that he personally thinks there is far too much secrecy in the system:
"A small part of individual [license] applications might be regarded as commercially confidential but the major proportion could, with little loss to anyone, be made publicly available. Similarly, I see no objection to Committee's papers being publicly available".1
Bearing in mind that, on leaving office, the previous Chairman of the CSM also complained quite emphatically about the secrecy2, these questions arise, and I would be grateful for your response to them:
[a] Would it be safe to assume that the MCA also accepts that most of the commercial confidentiality is unnecessary? Can you please confirm, at least, that there is no fundamental difference of opinion on this between the MCA and CSM?
[b] Would it not have helped the Select Committee to indicate either that the CSM Chairman's views were generally shared, or that there was some significant divergence of opinion here?
[c] What explanation can you give for the Scrip report (14-01-98) that the MCA would be "trying for exemption" - ie seeking to join the list of agencies exempted from the proposed FOI Act? It was an extraordinary statement to read (and Scrip is usually a reliable source), all the more so in the light of the MCA's comments to the Select Committee.
3. Under Q5, you give your best estimate of the numbers of requests the Agency might handle after passage of a Freedom of Information Act. I don't doubt your numbers, and I do realise how hard it would be to come up with anything at all precise, but please could you let me have copies of:
[a] Any facts and analysis underlying the Agency's estimate;
[b] Any related calculation, made before 9th February, estimating the numbers or proportion of FOI requests that would be likely to originate from pharmaceutical companies (including their agents), rather than from private individuals or other seekers after truth.
[c] Any estimates the MCA presently has of the proportion of business-related, and all other, FOI requests handled by the US Food and Drug Administration.
[d] Any other data which might cause the MCA to doubt that the great majority of FOI requests it is likely to handle will originate from pharmaceutical companies.
4. Apropos of this, it seemed rather coy to tell the Committee that the MCA's income "is principally derived from receipts for the services we provide", even if you did mentioned the MCA's Trading Fund status. As the Agency's income comes overwhelmingly from the pharmaceutical industry, via fees paid for the scrutiny of product license applications, would it not have been appropriate to refer in your submission to the Committee to:
[a] any implications for the Agency of having to find extra funding for the administration of FOI, and whether it could legitimately and readily do so by increasing license fees?
[b] whether the MCA's views on this were influenced by the expectation that the large majority of FOI requests might originate from (or on behalf of) pharmaceutical companies themselves?
[c] whether it would be appropriate and/or legitimate to recover costs from pharmaceutical industry requesters (including their agents), given that they already fund virtually the whole regulatory system via license fees?
5. Finally, the MCA submission to the Committee refers to the need to protect "commercial confidentiality such as intellectual property, sensitive information about product methods and techniques". In this connection, please would you let me have copies of any definitions or guidance relating to the meaning and interpretations of these terms that the MCA relies on, including all such references in current SOPs? May I also please request copies of any discussion relating to commercial confidentiality, recorded in (extracts of) Minutes of meetings of the CSM, over the past five years?
I would be very surprised (and reassured) if the MCA/CSM's concerns did primarily relate to the need to maintain confidentiality for those classes of information where disclosure is not the norm. I would think the MCA might get good support from consumer interests if it sought mainly to restrict disclosure relating to production technologies (not normally disclosed) - as opposed to the results of clinical and other tests relating to drug safety and efficacy. With this class of information, disclosure is the norm, even if there is an overwhelming bias towards publication of positive results, (with potentially dire consequences for the health and safety of some patients)
Thank you very much for considering these points.
Charles MedawarReferences 1, 2
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Contents page List of MCA/CSM Correspondence Select Committee on Public Administration