MHRA-LOGO.gif (6825 bytes) Medicines and Healthcare products
Regulatory Agency

Market Towers
1 Nine Elms Lane, London SW8 5NQ


Mr Charles Medawar
Social Audit Ltd
P.O. Box 111
London NW1 8XG

General enquiries

Telephone 020 7273 0600  Fax 020 7273 0737
E-mail [email protected]


18 August 2004 

Dear Mr Medawar,

I am replying to your letter of 8 August 2004, in which you ask for information about the effect that the repeal of section 118 of the Medicines Act and the full implementation of the Freedom of Information (FOI) Act in January 2005 will have on the transparency of the Medicines and Healthcare products Regulatory Agency (MHRA).

I do not believe that the repeal of section 118 of itself will make a radical difference to the MHRA’s policies and practices on disclosure of information. For some years the Agency has, in view of the duty of disclosure under the Code of Practice on Access to Government Information, not routinely used section 118 as a reason not to disclose information. However, the repeal of section 118 does demonstrate both to the public and to Agency staff that we are committed to being as open and transparent as possible within the provisions of the Code and, from 2005, the Act. The removal of this statutory bar, the existence of which may have represented a disincentive to potential open government requests and sent a confused message to Agency staff, clarifies the position in that we will have only the FOI Act itself to consider from January 2005 when responding to requests for information.

The implementation of individual rights of access to information under the FOI Act in 2005 introduces, for the first time in the UK, a statutory right to information. This is a very important development from the existing non-statutory Code. The act contains broadly similar exemptions to those in the Code, so I do not anticipate a large amount of information which we have previously withheld becoming available. We will, though, be guided by decisions of the Information Commissioner in our disclosure policy. The MHRA welcomes the Act and its recognition of the public’s statutory entitlement to information.

You also ask whether the MHRA has a definition of "commercial confidentiality". I enclose the Information Commissioner’s Freedom of Information Act Awareness Guidance no 5, which covers commercial interests and the FOI Act. This guidance discusses commercial interests, the concepts of "trade secrets", prejudice and the public interest test as they relate to section 43 of the FOI Act.

The MHRA will be using this guidance when dealing with FOI requests which raise issues of potential commercial confidentiality. Copies of the guidance, and other guidance relating to FOI, can be obtained from the Information Commissioner’s website at

Reconciling genuine commercial interests with the presumption for disclosure in the FOI Act will be an area of potential difficulty. We have, with colleagues from the Veterinary Medicines Directorate (VMD), been talking to representatives of the pharmaceutical and veterinary medicines industry. These talks have focused on what third party information might or might not be disclosed under the provisions of the FOI Act. Such discussions, although instigated before the Information Commissioner’s...guidance was issued, are envisaged at section F, sub-paragraph a) of the Awareness Guidance no 5. We hope to publish in October 2004 a Memorandum of Understanding between the MHRA, the VMD, the Association of the British Pharmaceutical Industry and the National Organisation of Animal Health. This Memorandum will set out what information the MI-IRA and VMD plan to disclose, may disclose after consultation with the third party, or plan to withhold unless the public interest in disclosure is greater than the public interest in withholding. This document will not be legally binding, but will provide a guide to Agency staff and third parties when considering FOI requests. The Memorandum will be a living document that will develop over time as the Agency gains experience in dealing with FOI requests and the Information Commissioner publishes further guidance. The Memorandum will be published on our website, though I will make sure that a hard copy is sent to you as soon as it is available. On publication we shall invite comments, and a formal review of the Memorandum will follow in the summer of 2005.

The Agency is making other preparations for the full implementation of FOI. We will be running a series of awareness and training sessions for all Agency staff, including a presentation to the Agency and Executive Boards in September by Maurice Frankel. We are also publishing a series of articles about FOI on our intranet. I enclose an example of an initial intranet message to staff~ its on-screen presentation is much more eye-catching than this. I can assure you that the Agency recognises the importance of being equipped to meet the challenges of FOI, and the Board is committed to ensuring that the Agency and its staff are ready for implementation in 2005.

Yours sincerely

Roy Alder
Head of Executive Support