13 Reports to the Code of Practice Appeal Board

section

13.1 The Authority must provide the Appeal Board with reports on complaints which have been submitted under the Code and details of the action taken on them. Where a case has been completed at Panel level, the Appeal Board shall consider whether additional sanctions may be appropriate.

 

13.2 The procedures set out below shall apply where:

(i) the Panel reports a company to the Appeal Board under the provisions of Paragraphs 10.1 and 10.2, or

(ii) the Panel reports the failure of a company to comply with the procedure set out in Paragraph 11, or

(iii) the Authority reports the failure of a company to comply with the procedures set out in Paragraph 12, or

(iv) the Appeal Board, having received a report on a case completed at the Panel level, in accordance with Paragraphs 13.1 and 4.1, considers that additional sanctions may be appropriate.

13.3 The company concerned must be 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 Chair. Such consent may be given only if the Chair is satisfied that no other person within the company can properly represent it in the matter in question.

 

13.4 Upon hearing the representations of the respondent company, if any, 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, a specific scope audit, a requirement that the respondent company provides updates regarding implementation of the company’s commitments to improve 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

• take other administrative steps as appropriate in line with the overriding objective, such as inviting a senior representative of a particular company to future meetings of the Appeal Board to report on progress, or requesting written confirmation that appropriate action has been taken.

13.5 Where a company not in membership of the ABPI fails to comply with the procedures set out in Paragraphs 5, 8, 11, 12 or 13 and indicates that it no longer wishes to accept the jurisdiction of the Authority, the Appeal Board may 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.