HC Deb 29 January 2003 vol 398 cc891-3W
Chris Grayling

To ask the Secretary of State for Health (1) if he will place in the Library(a) the discussion paper that the Medicines Control Agency used to provide the framework from which risk management options have been considered regarding kava-kava, (b) the information used to assess the economic impact of the various regulatory options considered by the Medicines Control Agency regarding kava-kava and (c) the Medicines Control Agency risk analysis for kava-kava on the viability risk management options other than banning kava-kava; [91471]

(2) if he will place in the Library data used by the Medicines Control Agency in considering the safety of kava-kava that relates to potential enzyme induction caused by (a) kava-kava and (b) registered medicines in association with kava-kava in adverse reaction case reports; [91472]

(3) if he will place in the Library the Medicines Control Agency's (a) risk benefit analysis in relation to kava-kava, (b) supporting documents and (c) expert advice; [91474]

(4) if he will place in the Library correspondence and submissions (a) sent to and (b) received by the Medicines Control Agency regarding the regulating of kava-kava. [91473]

Ms Blears

I am placing in the Library of the House copies of the following documents: the Medicines Control Agency's letters to interest groups about kava-kava; a summary of the responses received in response to the Agency's public consultation (MLX 286); copies of responses to the consultation received where permission has been received from the author; papers considered by the Committee on Safety of Medicines (CSM) and by the Medicines Commission; minutes of the meetings of the CSM held on 12 December 2001, 10 July 2002 and 16 October 2002; minutes of the meeting of the CSM's working group held on 12 March 2002; the final regulatory impact assessment (RIA).

Some of the papers considered by the advisory committees have been anonymised under the Code of Practice on Access to Government Information, as have parts of the minutes of meetings, under exemptions 10, 13, 14 and 15 of the code.

Minutes of the Commission's meeting of 7 November 2002 will be placed in the Library once the minutes have been formally ratified by the Commission. This is expected in February.

We will review all other documents sent and received by the MCA relating to kava-kava to assess what, if any information is subject to non disclosure under the code and seek permission for disclosure from external parties where necessary. The main categories into which these additional documents fall include: factual advice sought from and given by the MCA following inquiries from a wide range of external parties, including members of the public, about the regulatory position of kava-kava and the progress of consideration of safety issues; legal advice sought by and given to the MCA; factual information exchanged between the MCA and the Food Standards Agency, other Government Departments, regulatory authorities elsewhere in the European Union, papers reflecting policy advice to and discussion with Ministers. Some of these categories of information will be exempt from disclosure under the code.

In relation to kava-kava medicines with a marketing authorisation, exemptions 10, 13 and 15 of the code apply. This information remains confidential and publication would be premature while the issues are still under consideration; however, the advice will be published (some papers may be anonymised) once a regulatory decision has been made.

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