12 Code of Practice Appeal Board – Rulings and Sanctions

12.1 Where the Appeal Board rules that there is no breach of the Code, the complainant and the respondent company must be advised in writing and 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 thirty 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 thirty days an administrative charge based on the number of matters taken to appeal on which no breach is ruled.

 

12.2 Where the Appeal Board rules that there is a breach of the Code, the respondent company must be advised in writing and is given the reasons for the decision. The respondent company then has five working days to provide a written undertaking as specified in Paragraph 8.1.

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

12.3 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.

 

12.4 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, 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.

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

 

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

 

12.6 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.

 

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

 

12.8 Where the Appeal Board rules that there is no breach of the Code, it shall also determine whether additional sanctions as referred to in Paragraph 12 are appropriate in relation to breach rulings accepted at the Panel level.