Department of Health
Market Towers 1 Nine Elms Lane London SW8 5NQ
Telephone 0171-273 0600
Facsimile 0171- 273 0737 .
8 September 1998

Dear Mr Medawar,

Thank you for your letter of 8 August.

Responsibilities of CSM 

The Committee on Safety of Medicines (CSM), supported by a number of specialist sub-committees, was set up in 1970 under Section 4 of the Medicines Act 1968. It advises the Licensing Authority (i.e. UK Ministers) on questions of the quality, safety and efficacy of new medicines for human use. It also encourages the collection and investigation of reports on suspected adverse drug reactions to medicines already on the UK market. Further details of how CSM fulfils these duties are given in the annual report of the medicines advisory bodies published by the MCA. The 1997 report was published recently and I attach a copy.

CSM/MCA interface and the Code of Practice

The CSM and its sub-committees provide independent expert advice to the Licensing Authority. The MCA, as the Licensing Authority's executive arm, provides secretarial and administrative support to the CSM. The MCA, as part of Government, and its officials, as civil servants, are covered by the Code of Practice as are the papers which officials prepare for CSM.

However, as Professor Rawlins advised in his letter of 3 July, the CSM's actions are covered by Section 118 of the Medicines Act and not by the Code of Practice, since the CSM is an advisory non-departmental public body. Similarly, Agency Standard Operating Procedures do not apply to CSM members (though you may have noted that we have SOPs which give Agency staff advice on certain procedural Committee matters, such as appointing Members for the Day).

FOI legislation will, in due course, apply to all medicines advisory bodies. The Government is currently reviewing over 200 pieces of legislation such as section 118 to determine whether or not these should be repealed once FOI legislation is in place.

I trust you will find this information helpful.

Yours sincerely
Roy Alder
Head of Executive Support


Contents page
List of MCA/CSM Correspondence