10 Code of Practice Appeal Board - Rulings

10.1 Where the Appeal Board rules that there is no breach of the Code, the complainant and the respondent company are so advised in writing and are given the reasons for the decision.

Where a complainant pharmaceutical company appeals and the Appeal Board upholds the ruling that there is no breach of the Code, the complainant pharmaceutical company must pay within twenty working days an administrative charge based on the number of matters taken to appeal on which no breach is ruled.

Where a respondent company appeals and the Appeal Board rules that there is no breach of the Code, the complainant pharmaceutical company must pay within twenty working days an administrative charge based on the number of matters taken to appeal on which no breach is ruled.

10.2 Where the Appeal Board rules that there is a breach of the Code, the respondent company is so advised in writing and is given the reasons for the decision. The respondent company then has five working days to provide a written undertaking providing relevant information as specified in Paragraph 7.1 above.

The company must also pay within twenty working days an administrative charge based on the number of matters ruled in breach of the Code.

10.3 Where the Appeal Board rules that there is a breach of the Code, it may 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.

10.4 Where the Appeal Board rules that there is a breach of the Code, it may 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 Authory 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.

The Appeal Board may also require an audit if a company repeatedly breaches the Code.

10.5 Where the Appeal Board rules that there is a breach of the Code, it may reprimand the company and publish details of that reprimand.

10.6 Where the Appeal Board rules that there is a breach of the Code, it may 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.