|Department of Health|
|MEDICINES CONTROL AGENCY|
|Market Towers 1 Nine Elms Lane London SW8 5NQ|
|Telephone 0171-273 0600|
|Facsimile 0171- 273 0737||.|
|4 November 1998|
Dear Mr Medawar,
Thank you for your letter of 27 September.
I cannot accept your view that the CSM evades public accountability. It already publishes a great deal of information - for example, via its regular bulletins and reports on adverse drug reactions or more generally in the annual reports. These reports are public statements of the actions of the Committees for which they are accountable to Ministers who, in turn, are accountable to Parliament. I note your view that their advice should be as "open" as possible. I am certain you echo the views of many of the members of the advisory bodies. But the advice which bodies such as CSM give is to Ministers acting as the Licensing Authority. As such, they are bound by the terms of Section 1 1 8 of the Medicines Act until such time as Parliament sees fit to amend or repeal it.
However, the MCA is also bound to meet the obligations of the Code of Practice. That gives rise to the duty to disclose under Section 118. Since the MCA holds CSM papers, the correct approach under the Code is for requests directed to CSM to be referred to the MCA. This is our current practice. In this way, the standards of the Code are applied whether the request is made of the MCA or of the CSM. We do not seek to apply the legalistic distinctions you allege about the work of the MCA and the CSM. Rather, the fact that MCA and CSM are technically differently constituted should not present disadvantages to anyone seeking information under the Code.
Thank you for pointing out the inadvertent error in my earlier letter. You are quite right that the CSM's duties are not restricted to "new" medicines.
I am sorry that you feel aggrieved that you have not had answers to the scientific assessments you have sought. Your letter of 30 September spelt these concerns out in detail in relation to the MCA and we are currently working to see how we can best address these.
|Head of Executive Support|
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