ABPI code of practice

Finally, the representative must learn the details of the product licence and thus know how, when promoting the product, to avoid being in breach of either the Medicines Act or the ABPI Code of Practice, which is written specifically to assist company personnel in promoting products to prescribers in an appropriate manner. 

Pharmaceutical companies have recourse to aU the art of sophisticated advertising, promotion, public relations and specialist agencies, as well as having their own trained marketing professionals. Consequently written, documentary and published promotional items are usually reviewed and scrutinised by the company medical advisers for conformity with the known data and the ABPI Code of Practice, while the regulatory affairs professionals usually ensure conformity with the product licence. A pharmaceutical... 

The ABPI Code of Practice for the Pharmaceutical Industry has been regularly revised since its... 

The ABPI Code of Practice, in line with European Directive 75/319/EEC, calls for an efficient transfer of information on adverse drug reactions. In the case of defective medicines, an ABPI Batch Recall of Pharmaceutical Products system is in operation. In the ABPI Expanded Syllabus, batch recall is referred to in the Pharmaceutical Technology section and adverse drug reactions in the Pharmacology and Classification of Medicines and the Pharmaceutical Industry and the NHS sections. 

Voluntary codes of practice have been in use in many MS for many years. For example, in the United Kingdom, the ABPI Code of Practice is applicable to prescription medicines, and the Proprietary Association of Great Britain (PAGB) Code of Standards of Advertising Practice for over-the-counter medicines. 

CIOMS IV form for reporting of serious unexpected suspected adverse drug reactions www.cioms.ch. ABPI Code of Practice 2003. 

Medicines Control Agency, the Committee on the Safety of Medicines and the Medicines Commission, based on the product s possible use, any side effects and risk of its misuse. POMs and certain pharmacy sales medicines must not be promoted to the general public, but can be marketed to the medical profession. The Association of the British Pharmaceutical Industry (ABPI) Code of Practice regulates promotional activities (Association of the British Pharmaceutical Industry, 2001). 

Except in the US and New Zealand, where direct to consumer (DTC) advertising is allowed, companies are not allowed to communicate directly with patients. The Association of the Pharmaceutical Industry (ABPI) Code of Practice for the Pharmaceutical Industry has been relaxed a litde in this area in recent years and companies can now communicate in a very limited fashion with the general public. Clause 20.2 of the Code allows the provision of non-promotional information in response to a direct enquiry from an individual or via press conferences, press announcements, lectures and media reports, PR activities and the like. 

The EU has approved Council Directive No. 92/28/EEC (of 31 March 1992) on the advertising of medicinal products for human use, thus bringing Member States into line with common requirements and standards. The UK regulations have been amended to comply with the Directive. The Directive, Part IV of the UK Medicines Act 1968 as amended by the Advertising Regulations, and the ABPI Code of Practice for the Pharmaceutical Industry are broadly in line with one another. The commentary below on promotion relates primarily to the UK. Whilst there have been some moves towards the international harmonisation of controls on promotion, these have had only a limited effect, despite the fact that in Europe, Member States all comply with Directive 92/28. 

Complaints about pharmaceutical advertising made under the ABPI Code of Practice are taken up by the PMCPA. The PMCPA was established by the ABPI as from 1 January 1993 to administer the ABPI Code of Practice and consists of a director, secretary and deputy secretary. The authority is responsible for the provision of advice, guidance, conciliation and training on the Code of Practice, as well as for the operation of the complaints procedure. It is also responsible for scrutinising journal advertising on a regular basis. 

The rules regarding promotional gifts are clearly dealt with in the ABPI Code of Practice. Gifts to prescribers are not forbidden but must conform to certain sensible rules. They should not cost the donor more than 6 excluding VAT and they must have some relevance to the practice of medicine. Gifts should not be so prominent that they put the recipient... 

The ABPI Code of Practice for the Pharmaceutical Industry has been regularly revised since its inception in 1958 and is drawn up in consultation with the British Medical Association, the Royal Pharmaceutical Society of Great Britain and the Medicines Control Agency of the Department of Health. 

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