 |
Medicines
and Healthcare products Regulatory Agency Market Towers |
| Mr Charles Medawar |
General
enquiries Telephone 020 7084 2000 Fax 020 7084 2353 E-mail [email protected] www.mhra.gov.uk 22 December 2006 |
| REVIEW OF FOI REQUESTS: 06/350 1. INTRODUCTION 1.1 In a letter dated 27th November 2006, Mr Charles Medawar requested a review of the reply received from the Medicines and Healthcare products Regulatory Agency (MHRA) in relation to a Freedom of Information Act (FOIA) request numbered 06/350. In particular, he asks for a formal review of the Agency’s interpretation of Section 40 of the FOIA, specifically in relation to the "E Mail 2" attachment provided with the letter of response to the FOIA request dated 20 November 2006. 2. PURPOSE OF INTERNAL REVIEW 2. The purpose of this internal review is to determine whether the MHRA dealt properly with Mr Medawar’s requests under the FOIA. The terms of reference of this review are:
3. CONSIDERATION OF THE ISSUES 3.1 In a letter dated 21st October 2006, Mr Medawar made a request under the FOIA for a number of pieces of information including: "1. Please provide copies of all e-mails and any other record(s) of communication relating to me and/or this FOI request, sent from and received by your office during October 2006.". 3.2 Copies of e-mails were provided in the reply from the Agency dated 20 November but the names of the senders and recipients were redacted quoting Section 40 of the FOIA in mitigation. 3.3 Section 40 concerns personal data within the meaning of the Data Protection Act 1998. Section 40 applies to two distinct types of requests for information:
4. Conclusion and Recommendations 4.1 Having reviewed the correspondence between the Agency and Mr Medawar, I conclude that Section 40 of the FOIA has not been used correctly in these circumstances. The request made does not fit the criteria for requests for personal data (as outlined in para 3.3 above). However, having said that, I consider that the names should remain redacted but under Section 38 of the FOIA. Section 38 relates to information whose disclosure would be likely to endanger the physical or mental health or the safety of any individual. Section 38 is subject to a public interest balance and I believe that the public interest would not be met by revealing this information. There could be some danger to the individuals involved by revealing their names in the same way as revealing names of assessors who have had responsibility for a particular product could endanger their safety. 4.2 In Mr Medawar’s letter of 27th November, he states that he wanted to know "which bits of the MHRA were taking an interest, or playing some part, in our correspondence.". This was not spelt out in the original request. I see no problem in giving information about which parts of the Agency were involved in this particular e-mail, and strongly recommend that the Agency reveal this information as it would appear to that this will satisfy Mr Medawar’s request under review. Sue Jones ===================================================================================== FOI 06/350 Dear Mr Medawar Thank you for your letter of 27 November 2006 about text I redacted in an attachment to my letter of 20 November under Section 40 of the Freedom of Information Act (FOIA). Further to the MHRA internal review of 22 December 2006 (a copy of which I enclose), I am revealing to you which parts of the Agency were involved in "Email 2" of my letter of 20 November and these changes are indicated in bold text. I am still exempting release of names of individual MHRA staff members, but this is under Section 38 and not S40 of the FOIA. Again, these changes are indicated in bold. For consistency, I have also done the same for Email 1. Yours sincerely Stephen Fawbert Email 1 Subject: FW: FOI 06/236 Website Request Sun Oct 01 09:02:00 BST 2006 Hi [text redacted Section 38 FOIA] Kind Regards [text redacted Section 38 FOIA] Email 2 From: 1 staff member VRMM Pharmacovigilance Risk Management Group Subject: FW: FOI 06/324 (re. 06/236) I suggest the following response: The members of the CSM Expert working Group on SSRIs were supplied with an assessment of of MAH responses for the paroxetine referral at their meeting of 27 Feb 04. This assessment (of which I believe you have a copy) contained a summary of the cases of suicide with paroxetine. I would like to correct one of the points made in Miss Wark's letter of 4 September 2006. The case narratives themselves were not supplied to the SSRI Expert Working Group but were supplied to the European scientific advisory committee, the Committee for Medicinal Products for Human Use (CHMP). -----Original Message----- From: 1 staff member VRMM Pharmacovigilance Risk Management Group Sent: 10
October 2006 10:47 This is a reply we sent to Medawar in Feb this year about details of the case
narratives for the placebo suicides in which we specify what info on the case narratives
were provided to the EWG. -----Original Message----- From: 1 staff member VRMM Pharmacovigilance Risk Management Group Sent:
09 October 2006 09:12 We spoke about this on Friday. Grateful if you could look back in the records. Happy to discuss [text redacted Section 38 FOIA] -----Original Message----- From: I staff member MHRA Information
Centre To: 1 staff member VRMM Pharmacovigilance Risk Management Group Cc: I staff member MHRA Information Centre, 2 staff members Policy Division, 2 Staff members VRMM FOI Team Subject: FOI 06/324 (re. 06/236) [text redacted Section 38 FOIA] - thank you for your comments. This is therefore a new FOI case (Ref FOI 06/324). The deadline for reply is 30 October. Please remember to send [text redacted Section 38 FOIA]and myself copies of the reply. Thanks
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