Department of Health
Market Towers 1 Nine Elms Lane London SW8 5NQ
Telephone 0171-273 0270
Facsimile 0171- 273 0293
23 January 1998

Dear Mr Medawar

Thank you for your letter of 24 December 1997. You have requested comment on a number of issues, which is provided below:

1. As indicated in Dr Price's letter of 23 November the statement you refer to was included in the discussion of our paper to explain an apparent discrepancy between the findings of spontaneous adverse reaction reporting and those of prescription event monitoring as published at that time. As also indicated in Dr Price's letter there has been a further publication on the findings of prescription event monitoring which demonstrates a difference in frequency of withdrawal reactions between paroxetine and other SSRIs. We consider that there is no consensus on the frequency of clinically important symptoms on SSRI discontinuation, but would accept that they may not be as rare as suggested in our original paper. We however do not see this as a basis for withdrawal of the paper which provided a comparison of the post-marketing safety of 4 SSRIs. In your letter of 16 January to Dr Jones you refer to a survey of physicians' knowledge of antidepressant withdrawal effects published in J Clin Psychiatry 1997,. 58 (supp 7) 28-30, which provides information on the level of awareness and likelihood of reporting of discontinuation events for antidepressants. This issue equally applies to other adverse reactions and the findings do not provide direct evidence of the frequency of withdrawal reactions after discontinuation of antidepressants.

2. You queried my use of the phrase "may harm" as against the Code's reference to "would harm". The general preamble at the start of Part II of the Code states that references to harm or prejudice in the exemptions include "risk or reasonable expectation of harm or prejudice". It was in this context that I used the phrase "may harm."

3. You asked what "harm" would be done. I gave our reasons in my previous letter but the following amplification may help. We sought the views of the company on your request. Their view was that the information was commercially confidential and would give an advantage to competitors. We saw no reason not to accept this view. We decided that disclosure risked harming the competitive position of the company which owns the data. We also took the view that disclosure risked prejudicing the future supply of confidential information, necessary to support the marketing authorisation process, and supplied on the understanding that it would not be released. We considered there was no risk to public health or safety sufficient to override these reasons.

4. It remains, of course, open to the owners of the data to publish the results of clinical trials and information about the incidence of any withdrawal reactions. The views of the licence holder on this are a matter for them.

5. You asked under what circumstances disclosure is unwarranted. I am enclosing a copy of the Guidance on the Code which was revised in 1997. This issue is addressed at page 67.

6. Exemption 13 of Part 11 of the Code sets out the definition of commercial confidence we have applied in this case. Further information about use of the terms "commercial confidences, trade secrets and intellectual property" is given in the Guidance at pages 68/69. Exemptions 13 and 14 applied to all of para. 3 of your request of 23 October, with the exception that Exemption 13 did not apply to para. 3(b).

7. The test of an overriding public health or safety risk is set out in general terms in the second paragraph of the preamble to Part II of the Code. In considering any of the exemptions referring to harm or prejudice "it should be considered whether any harm or prejudice arisingfrom disclosure is outweighed by the public interest in making information available. "

8. I appreciate the difficulties you express about where the public interest lies. We consider there are different, competing aspects to take into account: -

firstly, that we make as much information available as possible;

secondly, that we do not release information exempted from disclosure; and

thirdly, that, even if exempted, we do release information if the risk to public health or safety warrants it.

My previous letter and this reply have set out the reasons for non-disclosure in this case and the factors we took into account.

9. The MCA maintains its complaints procedure with the option for referrals to be made to the MCA's Independent Complaints Advisor. This procedure covers the Agency as a whole and does not just apply to Code procedures. You can make a formal complaint to Dr Jones at any time.

10. Under Code procedures, the first stage in appealing my decision would be for you to refer the matter to Dr Jones for an internal review. Depending on the outcome of that review, if you are still dissatisfied, you can make a complaint to a Member of Parliament for referral to the Ombudsman (Parliamentary Commissioner for Administration) who will decide whether or not to carry out his own investigation.

11. I hope this answers the concerns you raised. With reference to the White Paper, I would emphasise that the Government is committed to removing unnecessary secrecy and to encouraging more open and accountable government. At the same time, the proposals are designed to strike a proper balance between access to official information and preserving confidentiality, subject to a strict harm test, where disclosure would not be in the public interest. In this context, the issues you have raised in this request are clearly going to be important for the future. We have dealt with them here within the terms of the Code which will continue to apply until such time as Freedom of Information legislation comes into force. In the interim, we are continuing our review of existing policies, with a view to maximising public access to information about medicines whilst safeguarding legitimate confidential interests.

Yours sincerely

Director, Post-Licensing Division


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