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 29 June 1998

Dear Mr Alder,

Thank you for your letter of 26 June enclosing the report of Dr Munro's investigation of our complaint. I got the joke about my 'continued patience', but only just. Dr Munro's report clearly shows that our rights under the Code have been abused; if it takes the MCA four months to correct the injustice, it says enough about the spirit of the organisation to be worth waiting for.

The most striking thing about Dr Munro's report is the finding, "I can see no reason not to respond/release …", in four of the seven complaints he investigated. If, after four months, a close but lower-ranking colleague is unable to find any reason not to release the requested information, it is a safe bet that the Chief Executive Officer never had any reasons he would care to admit. So the question is, was the CEO either flaunting the Code, or completely unfamiliar with it, or what?

Understandably, Dr Munro has not addressed such matters, but they are issues worth thinking about. What should be done if a CEO operates way out of line with Standard Operating Procedures? What if he knowingly took the public for a ride, or if he honestly felt that he had to brush aside the Code to uphold the public interest? Would this be acceptable performance for a junior MCA employee, and is it any more or less acceptable for an Agency head?

Of course Dr. Jones had his reasons for refusing disclosure, and we may take for granted that he thought he was doing the right thing. Therefore I can only think that the purpose of the original blanket refusal was to buy time and avoid embarrassment. Indeed, for all the evidence of adherence to process, the MCA's enquiries barely indicate a determination to assess the risks outlined in our report. The main aim seems to have been not to assess risk, but to present a credible and united front - and all through a process of "consultation" conducted in secret and involving only the manufacturers and other EU regulatory agencies, all parti pris.  

Only a full investigation would reveal exactly what the fear of embarrassment was about, but the MCA clearly judged it would outweigh any embarrassment about abusive non-disclosure - and the risk of this was never negligible. If no good reason ever existed for refusing four of the seven requests for information, people might wonder if the MCA was to be trusted with the implementation of Freedom of Information law - indeed, whether the proposed Act would be strong enough to bring the Agency into line.

Then what does this reveal about the Agency's commitment to The Seven Principles of Public Life? "Holders of public office should take decisions solely in terms of the public interest… (Selflessness) … are accountable for their decisions and actions to the public… (Accountability)… should be as open as possible about all the decisions and actions they take… (Openness) … should promote and support these principles by leadership and example (Leadership)". In the circumstances, it would seem understandable if some people were also concerned about the Agency's ability to conduct proper enquiries into the safety of drugs.

Your letter did not include the MCA's 'brief report' to the January meeting of the EMEA/CPMP Pharmacovigilance Working Party, and I should now like formally to request a copy of this.

Please will you also let me have a list of any bodies formally consulted on this matter between 16 January 1998 and the end of May, indicating in each case: [i] what questions you asked (supplying a sample letter if possible); [ii] whether you invited those consulted to submit evidence in confidence and, if not, whether they requested it; and [iii] whether I might in due course see any of their replies.

I shall write to you again about the Agency's continuing refusal to disclose any information received from any of the parties consulted. Your claim to an Exemption under 1c - "Information whose disclosure would harm the conduct of international relations or affairs" - is a little gem, pure Norwegian Blue.

Yours sincerely,

Charles Medawar



Contents page
List of correspondence with MCA/CSM