11 Reports to the Code of Practice Appeal Board

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11.1 Where the Panel reports a company to the Appeal Board under the provisions of Paragraphs 8.1 and 8.2 above, or where the Panel reports the failure of a company to comply with the procedure set out in Paragraph 9 above, or where the Authority reports the failure of a company to comply with the procedures set out in Paragraph 10 above, the procedures set out below shall apply. These procedures also apply if the Appeal Board, having received a report on a case completed at the Panel level, in accordance with Paragraph 4.1 above, considers that additional sanctions may be appropriate.

11.2 The company concerned is provided with a copy of the report prior to its consideration and is entitled to have a representative or representatives appear before the Appeal Board to state the company’s case.

A company may not be represented before the Appeal Board by a representative who is also a member of the Appeal Board except with the consent of the Chairman. Such consent may be given only if the member of the Appeal Board can satisfy the Chairman that no other person within his/her company can properly represent it in the matter in question.

11.3 The Appeal Board may:

  • reprimand the company and publish details of that reprimand
  • require an audit of the company’s procedures in relation to the Code to be carried out by the Authority and, following that audit, decide whether to impose requirements on the company concerned to improve its procedures in relation to the Code; these could include a further audit and/or a requirement that promotional material be submitted to the Authority for pre-vetting for a specified period; the Authority must arrange for material submitted for pre-vetting to be examined for compliance with the Code but it cannot approve such material; all of the costs of pre-vetting must be met by the company concerned
  • require the company to issue a corrective statement; details of the proposed content and mode and timing of dissemination of the corrective statement must be provided to the Appeal Board for approval prior to use
  • require the company to take steps to recover items given in connection with the promotion of a medicine or non-promotional items provided to health professionals and members of the public and the like; written details of the action taken must be provided to the Appeal Board.

 

11.4 Where a company not in membership of the ABPI fails to comply with the procedures set out in Paragraphs 5, 7, 9 or 10 above and indicates that it no longer wishes to accept the jurisdiction of the Authority, the Appeal Board may decide to remove the company from the list of non member companies which have agreed to comply with the Code and advise the Medicines and Healthcare products Regulatory Agency that responsibility for that company under the Code can no longer be accepted.

The ABPI Board must be advised that such action has been taken.