Practice for the Pharmaceutical Industry

Code of Practice for the Pharmaceutical Industry 2003, Clause 14.1. London PMCPA, 2003. 

The EU has approved Council Directive No. 92/28/EEClO (of 31 March 1992, now consolidated as Articles 86 to 100 of Directive 2001/83/EC) 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 ABPl Code of Practice for the Pharmaceutical Industry are broadly in line with one another. The commentary below on promotion relates primarily to the United Kingdom. While 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. 

The ABPI is the trade association that represents the manufacturers of prescription medicines. Formed in 1930, it now represents some 80 companies, which produce over 80% of the medicines supplied to the National Health Service (NHS). The ABPI has had a code of practice since 1958, the Code of Practice for the Pharmaceutical Industry, which governs the promotion of medicines to health professionals, and has operated a system whereby complaints made about the advertising of prescription medicines are taken up and considered under the Code. It is a condition of membership of the ABPI to abide by the Code of Practice. In addition, some 70 companies that are not members of the ABPI have given their formal agreement to abide by the Code and to accept the jurisdiction of the PMCPA over complaints made under the Code. Thus, the Code... 

The aim of the Code of Practice for the Pharmaceutical Industry is to ensure that the promotion of medicines to members of the health professions and to administrative staff is carried out in a responsible, ethical and professional manner. The Code recognises and seeks to achieve a balance between the needs of patients, industry, health professionals and the general public, bearing in mind the political and social environment within which the industry operates and the statutory controls governing medicines. 

The Code of Practice for the Pharmaceutical Industry is administered by the Prescription Medicines Code of Practice Authority. The Authority is responsible for the provision of advice, guidance and training on the Code of Practice as well as for the complaints procedure. It is also responsible for arranging for conciliation between companies when requested to do so and for scrutinising journal advertising on a regular basis. Complaints 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 cases are published quarterly by the Authority and are available on request. 

The Code of Practice for the Pharmaceutical Industry and this Constitution and Procedure may be amended by a simple majority of those present and voting at a General Meeting of the ABPI. 

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. 

Reynolds DW. Available regulatory guidance and best practices for conducting forced degradation studies. Forced Degradation Studies Best Practices for the Pharmaceutical Industry. Institute for International Research, Princeton, NJ, Feb 24-25, 2004. 

Wingate, G. A. S. (2000), Corporate Computer Systems Validation Good IT Practice for the Pharmaceutical Industry, Interpharm Press, Buffalo Grove, IL. 

Irish Pharmaceutical Healthcare Association. Code of Marketing Practice for the Pharmaceutical Industry, 6th edn, December 2005... 

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. 

Code of Practice for the Pharmaceutical Industry (Clause 18.1) 2001. London, ABPI, 2001. Association of the British Pharmaceutical Industry/British Pharmaceutical Market Research Group. Guidelines on Pharmaceutical Market Research Practice. London ABPI, 1992. 

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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