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Mrs Sue Jones, Central Complaints Officer, Room 16-107
Medicines and Healthcare products Regulatory Agency
Market Towers, 1 Nine Elms Lane
London SW8 5NQ

12 June 2005


Dear Mrs Jones,

I am writing to complain about the handling of a complaint I made to Mr Leslie Whitbread, Secretary of the CSM, about delays in posting the minutes of the Sub-committee on Pharmacovigilance of the CSM. The Agency’s failure to post these minutes promptly goes back several years:

In May 2003, I tried to get copies of SCOP minutes, which hadn’t been posted since the end of 2000. It took several letters and a four-month wait to obtain them.

In June 2004, the same thing happened again. It took over 6-weeks to obtain the minutes on this occasion – the result of what Dr Williams referred to as "an oversight on the part of the Agency". Mr Alder found my complaint about the delay to be "fully justified". I was assured (OG4/52) that, "In future summary minutes will be placed on the website directly following the meeting at which they are agreed."

In April 2005, I complained again because the minutes of SCOP meetings hadn’t been posted for a year. This time, the delay amounted to a mere four weeks. Dr Williams refers to "administrative problems" and asks me to accept apologies. I am not prepared to do this. Dr Williams response, 5 May 2005, is just a cut & paste job of the response sent on 23 July 2004 – but transforming ‘an oversight’ in 2004 into ‘administrative problems’ in 2005. This seems too glib, by far.

My letter to Mr Whitbread of 11 April was made as a formal complaint, but has not been treated as such. Why is that? I am still waiting for answers to the questions I raised on 11 April: why have these delays occurred and who is responsible for them? Why are SCOP minutes consistently posted much later than the minutes of other CSM meetings? What steps were taken to improve matters, following my two previous complaints about the same problem in 2003 and 2004? What MHRA procedures govern the timely publication of minutes; have these been adhered to and, if not, why not?

Sorry to be testy: I just don’t want this to become an annual ritual.

Yours sincerely,
Charles Medawar