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

Dear Mr Medawar,

I am writing further to my letters of 11 November and 9 December, and the review we conducted of relevant requests relating to information about the Committee on Safety of Medicines (CSM).

I enclose the following documents (suitably edited):

i) the MCA assessment report of (minus your own article) withdrawal reactions associated with     SSRIs and related antidepressants which was presented to the CSM on 26 March; and

ii) an extract of the CSM minutes which discussed this item.

We have prepared these against the criteria set out in our review dated 23 November. I sent you a copy of this on 9 December. Those criteria are that we maintain confidentiality, except where information is clearly available and disclosure would not prejudice past understandings of confidentiality.

MCA assessment report

We have made minor deletions to the MCA assessment report and, more substantially, deleted two sections as follows:

pages 32 - 34 : data supplied by EU member states has been deleted on the grounds that it is subject to exemptions 1(c) and 2 of Part II of the Code of Practice on Access to Government Information (information which has been received in confidence from foreign governments, confidential communications between .... regulatory authorities).

pages 36 - 49 : information supplied by marketing authorisation holders, and the MCA discussion of such information in the paper, has been deleted on the grounds that it is subject to exemptions 2, 7(b), 13 and 14 of Part II of the Code of Practice on Access to Government Information (internal opinion and advice, information which would harm the Agency's effective management and operations, commercial and other information supplied in confidence).

I set out our reasons in my letters to you of 26 June (ref OG 98/4) and 8 September (ref OG 98/59). Whilst we did not explicitly promise confidentiality, our consultations with bodies such as other regulatory authorities and marketing authorisation holders are usually on the implicit understanding that we will not divulge individual views. We need to preserve the facility for exchange of information between us and our counterparts on a confidential basis. For the same reasons, we have also deleted the MCA's discussion of this information. MCA needs to be able to express views frankly and candidly. In addition, I advised you in my letter of 17 August (ref OG 98/49) that one respondent explicitly requested confidentiality. Dr Munro, in his report on your previous appeal, also found that we should not release this information for the reasons he gave in that report.

Please also note the following:

Cover Sheet

The box labelled 'Previous Assessments' on the cover sheet contains a list of those meetings where any issues relating to any of the drug substances were discussed.

Foreign ADROIT Report

We do not normally release foreign ADROIT data but there is no reason to exclude these data from the assessment report here. However, foreign ADROIT data should be interpreted with care since the records are not complete for all drugs. This is because foreign adverse drug reaction reports were not systematically entered onto the ADROIT database until 1994, which was after the marketing date of some of the relevant drugs. In addition, the reporting requirements for suspected adverse drug reactions occurring outside the UK should be taken into account when interpreting these data. Marketing authorisation holders are required to report to the MCA within 15 days, all serious suspected adverse drug reactions occurring in Europe and all serious and unexpected suspected adverse reactions occurring outside Europe. The expectedness of an adverse reaction is determined by whether or not it is listed in the local product information in the country where the reaction occurred.'

Data from external sources

The report contains

PPA, WHO and MediPlus® have all agreed that the MCA can release this information but you are asked to note the following:

PPA data - These prescription data are based on items and cover all prescriptions dispensed by community pharmacists, appliance contractors, dispensing doctors, and prescriptions submitted by prescribing doctors for items personally administered. The data refer to products dispensed in England only. Data prior to 1991 are based on a sample of 1 in 200 prescriptions, dispensed by community pharmacists and appliance contractors only.

MediPlus® - It should be noted that the database Intercontinental Medical Statistics (IMS) who manage the MediPlus® database, were not involved in the analysis of these data. The interpretation of the results is that of the MCA.

Minutes of the CSM meeting on 26 March

The minutes of the CSM meeting have been edited to remove personal or otherwise confidential material for the reasons I gave in my earlier replies of 8 and 11 September (ref OG 98/18 etc. OG 98/59).

Other material

I hope to be able to send the remaining material which we have reviewed early in the New Year. I am sorry this has taken rather longer than I anticipated when I wrote to you earlier this month.

I believe there is a considerable amount of information in these papers. You will appreciate that this has taken up rather a lot of our resource. I cannot rule out the possibility that we would levy a charge on any similar requests in future though there is, of course, no question of us doing so on this occasion.

I am copying this letter and the enclosures to the Office of the Parliamentary Commissioner for Administration.

Yours sincerely
Roy Alder
Head of Executive Support


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List of correspondence with MCA/CSM