|Department of Health|
|MEDICINES CONTROL AGENCY|
|Market Towers 1 Nine Elms Lane London SW8 5NQ|
|Telephone 0171-273 0600|
|Facsimile 0171- 273 0737||our ref: OG 98/04.|
|26 June 1998|
Dear Mr Medawar,
PAROXETINE: REVIEW OF REFUSAL TO DISCLOSE INFORMATION
1. I am writing further to my letters of 16 and 22 June.
2. Dr Munro has completed the review you requested on 11 February of the MCA's refusal to disclose various information concerning paroxetine as set out in Dr Jones' letter of 6 February. I attach a copy of Dr Munro's report. I am sorry this has taken longer to complete than we would normally expect and I am grateful for your continued patience.
3 . We have accepted Dr Munro's recommendations and the information which we previously refused is set out below.
4. Before 16 January 1998, we had consulted by fax or by letter all regulatory authorities in EU member states and the following holders of marketing authorisations:
|Eli Lilly & Co Ltd|
|SmithKIine Beecham Pharmaceuticals|
|Solvay Healthcare Ltd.|
|John Wyeth and Brother Ltd.|
|Bristol-Myers Squibb Pharmaceuticals Ltd|
5 . Representative examples of the fax and the letter we sent are attached. These include details of particular points about which we sought views. We sent copies of your article to our EU regulatory authority counterparts but not to the companies concerned, where we cited the reference for your article.
6. You will note that our original letters did not explicitly promise confidentiality. However, when we consult bodies such as those listed in para. 4 above, it is usually on the implicit understanding that we will not divulge individual views. For the reasons set out in Dr Munro's report, I am unable to provide copies of replies we have received to our enquiries.
7. Dr Jones' letter of 6 February answered your question regarding when Dr Price first became aware of certain information. You will however wish to note that Dr Munro concluded that, even had that information been known, we would have been justified in refusing to disclose that information under the Code.
8. Your letter of 11 February asked 3 further questions on which I promised to reply.
Which if any extracts of the paper were sent to any of those consulted?
9. Please see para. 5 above.
If extracts were copied, whether the MCA complied fully with copyright law?
10. This question involves an interpretation of copyright law about which the MCA can offer no opinion. You recently indicated that you would be happy to drop this request subject to my confirming one point which I did in my letter to you of 22 June. However, I would like to set out our position for the record.
11. The MCA has an agreement with the Copyright Licensing Agency (CLA). In return for a fee, this allows the MCA to make copies of articles printed in various journals, including the International Journal of Risk and Safety in Medicine. Following your letter of 11 February, we carried out an audit of the copies we had made. We found we had inadvertently exceeded the number of copies permitted. We agreed payment for the additional copies with the CLA and re-issued our existing Standard Operating Procedure on Photocopying Books and Journals in May to remind new and existing staff of the MCA's obligations.
Did the MCA's invitation to comment ask those consulted if they requested that their replies be treated in confidence?
12. Please see paras. 5 & 6 above and the examples attached to this letter.
13. If you have any query about this letter, please contact me. If you are unhappy with the outcome of our review, or you wish to appeal our decision to continue not to provide certain information which you requested, you may ask a Member of Parliament to make a complaint on your behalf to the Ombudsman (known officially as the Parliamentary Commissioner for Administration) who will decide whether or not to conduct his own enquiry. His address is Millbank Tower, Millbank, London SWIP 4QP.
14. Once again, I apologise for the delay in completing this review, but I hope that you find its results useful.
|Head of Executive Support|
|CLICK HERE TO READ ON|
|OR HERE TO SEE Dr MUNRO'S REVIEW|
|OR HERE TO SEE FAX/LETTERS OF CONSULTATION|