Prescription Medicines Code of Practice

PRESCRIPTION MEDICINES CODE OF PRACTICE AUTHORITY CONSTITUTION AND PROCEDURE... 

It is a condition of membership of the ABPI to abide by the Code in both the spirit and the letter. Companies which are not members of the Association may give their formal agreement to abide by the Code and accept the jurisdiction of the Prescription Medicines Code of Practice Authority and about seventy have done so. Thus the Code is accepted by virtually all pharmaceutical companies operating in the UK. 

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. 

Complaints about the promotion of medicines should be submitted to the Director of the Prescription Medicines Code of Practice Authority, 12 Whitehall, London SWIA 2DY, telephone 020-7930 9677, facsimile 020-7930 4554. 

Where market research is carried out by an agency on behalf of a pharmaceutical company, the agency must reveal the name of its client to the Prescription Medicines Code of Practice Authority when the Authority requests it to do so. When commissioning market research, a company must take steps to ensure that its identity would be so made know to the Authority should a request for that information be made. 

Companies shall preserve certificates and the relevant accompanying information for not less than three years after the final use of the promotional material or the date of the meeting and produce them on request from the Medicines and Healthcare products Regulatory Agency or the Prescription Medicines Code of Practice Authority. 

Companies must prepare detailed briefing material for medical representatives on the technical aspects of each medicine which they will promote. A copy of such material must be made available to the Medicines and Healthcare products Regulatory Agency and the Prescription Medicines Code of Practice Authority on request. Briefing material must comply with the relevant requirements of the Code and, in particular, is subject to the certification requirements of Clause 14. 

In the event of extenuating circumstances, such as prolonged illness or no or inadequate opportunity to take the examination, the Director of the Prescription Medicines Code of Practice Authority may agree to the continued employment of a person as a representative past the end of the two year period, subject to the representative passing the examination within a reasonable time. 

Details of the numbers of medical and generic sales representatives who have passed the respective examinations above, together with the examination status of others, must be provided to the Prescription Medicines Code of Practice Authority on request. 

A copy of the materials must he made available to the Prescription Medicines Code of Practice Authority on request. 

The number of working days within which companies or complainants must respond to enquiries etc, from the Prescription Medicines Code of Practice Authority, as referred to in the above procedures, are counted from the date of receipt of the notification in question. 

Prescription Medicines Code of Practice Authority, but not thereafter. 

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. 

Appropriate arrangements should be in place for training on the requirements of the Code. These may be internal arrangements for appropriate staff members but key personnel should attend one of the seminars organised by the Prescription Medicines Code of Practice Authority. 

Day-to-day control over the advertising of prescription-only medicines is provided by the Prescription Medicines Code of Practice Authority (PMCPA), part of the Association of the British Pharmaceutical Industry (ABPI). The PMCPA administers the code of conduct for pharmaceutical companies - often referred to as the ABPI code . 

ABPI Guidelines, 4th edition, draft 2004 (MJ Boyce). Prescription medicines code of practice authority, constitution and procedure, operative from July 1,2001. Presentation notes from MHRA breakfast meeting, Thursday, February 26, 2004. 

Such support can involve responding to complaints about promotional activities, which may come from other companies or external agencies such as, in the UK, the Prescription Medicines Code of Practice Authority. A medically qualified person should certainly have overall responsibility for clinical drug safety issues (see Section 9.3.6). Pharmaceutical physicians are usually involved in the training of sales representatives. In addition, a good pharmaceutical physician can be a credible ambassador for the company when lecturing to external audiences or dealing with the communication media. 

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