Code of Practice Appeal Board

The Code of Practice Appeal Board may also require a company ruled in breach to take steps to recover items distributed in connection with the promotion of a medicine. A variety of additional sanctions are available to the ABPl Board of Management following receipt of a report from the Appeal Board. The ABPI Board of Management can reprimand a company and publish details of that reprimand, require an audit to be carried out by the Code of Practice Authority of the company s procedures in relation to the Code and, following that audit, decide whether to impose a requirement on the company to improve its procedures in relation to the code. The ABPI Board of Management can also require a company to publish a corrective statement and, in extreme... 

The Code is administered by the Prescription Medicines Code of Practice Authority which is responsible for the provision of advice, guidance and training on the Code as well as for the complaints procedure. Complaints which are made under the Code about promotional material or the promotional activities of companies are considered by the Code of Practice Panel and, where required, by the Code of Practice Appeal Board. Reports on completed cases are published quarterly by the Authority in its Code of Practice Review which is available on request. 

The Authority also administers the complaints procedure by which complaints made under the Code are considered by the Code of Practice Panel and, where required, by the Code of Practice Appeal Board. 

The Code of Practice Appeal Board and its Chairman are appointed by the Board of Management of the ABPI. The appointment of independent members to the Appeal Board is made following consultation with the Medicines and Healthcare products Regulatory Agency. 

The Code of Practice Appeal Board meets as business requires to consider appeals under the Code and any other matter which relates to the Code. The Appeal Board receives reports on all complaints which have been submitted under the Code and details of the action taken on them. 

Upon receipt of the comments from the respondent company, the Director must determine whether there is a prima facie case to answer under the Code. If, in the view of the Director, no prima facie case has been established the complainant and the respondent company are so advised. If the complainant does not accept that view, the matter is referred to the Chairman of the Code of Practice Appeal Board for his decision which is final. 

When advised of the outcome, the complainant will be sent a copy of the comments and enclosures submitted by the respondent company in relation to the complaint. If the respondent company objects to this because it regards part of the material as being confidential, and the matter cannot be settled by the Director, then it will be referred to the Chairman of the Code of Practice Appeal Board for his decision which is final. 

The complainant or the respondent company may appeal against rulings of the Panel to the Code of Practice Appeal Board. Appeals must be lodged within ten working days of the notification of the ruling of the Panel and must be accompanied by reasons as to why the Panel s ruling is not accepted. These reasons will be circulated to the Appeal Board. 

Code of Practice Panel Reports to the Code of Practice Appeal Board... 

Failure to comply with the procedures set out in Paragraphs 5, 6 and 7 above shall be reported to the Code of Practice Appeal Board for consideration in relation to the provisions of Paragraph 12.1 below. 

Where the Code of Practice 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. 

Code of Practice Appeal Board Reports to the ABPl Board of Management... 

Where the Code of Practice Appeal Board considers that the conduct of a company in relation to the Code or a particular case before it warrants such action, it may report the company to the Board of Management of the ABPl for it to consider whether further sanctions should be applied against that company. Such a report may be made notwithstanding the fact that the company has provided an undertaking requested by either the Code of Practice Panel or the Appeal Board. 

Notice of appeal may be withdrawn by a respondent company at any time but if notice is given after the papers relating to its appeal have been circulated to the Code of Practice Appeal Board, then the higher administrative charge will be payable. 

Where the Code of Practice Panel or the Code of Practice Appeal Board identifies a possible breach of the Code which has not been addressed by the complainant in a case, the respondent company is invited to comment. The company has ten working days to respond in writing. 

The Prescription Medicines Code of Practice Authority is available to provide informal guidance and advice in relation to the requirements of the Code and, where appropriate, may seek the views of the Code of Practice Appeal Board. 

The views of the Prescription Medicines Code of Practice Authority and the Code of Practice Appeal Board must be sought on any proposal to amend the Code or this Constitution and Procedure. The views of the Medicines and Healthcare products Regulatory Agency, the British Medical Association and the Royal Pharmaceutical... 

Paragraphs 10.4 and 12.2 of the Constitution and Procedure for the Prescription Medicines Code of Practice Authority authorize respectively the Code of Practice Appeal Board and the Board of Management of The Association of the British Pharmaceutical Industry to require an audit of a company s procedures in relation to the Code of Practice for the Pharmaceutical Industry to be carried out by the Prescription Medicines Code of Practice Authority. 

Complaints submitted under the Code of Practice are considered in the first instance by the Code of Practice Panel, which comprises the Director, Secretary and Deputy Secretary of the Code of Practice Authority, acting vrith the assistance of independent expert advisers. Both the complainant and the respondent company may appeal to the Code of Practice Appeal Board against rulings made by the Panel. The Code of Practice Appeal Board is chaired by an independent, legally qualified chairman and includes representatives of the pharmaceutical industry within the UK as well as independent members from outside the industry. Details of its composition appears in the PMCPA Constitution Procedure, which appears with the Code of Practice. 

The Code of Practice Appeal Board may also require a company ruled in breach to take steps to recover items distributed in connection with the promotion of a medicine. A variety of additional sanctions are available to... 

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