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ABPI Code of Practice - an Overview

ABPI Code of Practice - an Overview
(Published 19 January 2004)

All promotional activity undertaken by pharmaceutical companies is covered by the requirements of the Association of the British Pharmaceutical Industry (ABPI) Code of Practice. The aim of the Code is that all promotion should be responsible, ethical and professional (It is probably only a coincidence that this abbreviates to ‘R.E.P.’, but it is an easy way to remember it.)

The Code itself is a self-regulatory system, but it reflects the requirements of the Medicines Act and the European Advertising Directives, which are legally binding. The Code only covers pharmaceutical companies, while the legislation also covers doctors, pharmacists and other health professionals.

Why do representatives need to know about the Code? Firstly, questions on the Code are now a compulsory part of the ABPI Representatives’ Examination. Unless representatives pass this exam within two years of starting work, they cannot be employed as representatives. Secondly, and arguably more importantly, representatives who don’t know about the Code, can get their companies into trouble.

The Code operates as a complaints system. Complaints are accepted from any source, but tend to come mainly from doctors or other health professionals, or from pharmaceutical companies - usually competitors. Complaints are fully investigated by the Prescription Medicines Code of Practice Authority (PMCPA) and if it is decided that a company has breached the Code in any way, the company will be fined. For serious breaches, the company may be required to undergo an audit or may be publicly reprimanded. Full details of the complaint and the outcome are published, quarterly, in the Code of Practice Review.

The Code covers everything which can be considered to promote the use of a company’s medicine. This can cover a wide variety of activities, including advertising, mailings, public relations, meetings. Most importantly, it covers ALL representative activity. It is considered that a representative’s job, essentially, is to sell i.e. to promote. Representatives therefore are considered inherently promotional, and the Code thus covers everything they do, say, use or pay for.

The Code is a fairly substantial document, which sets out the requirements in relation to different promotional activities. The requirements are sometimes very detailed, and sometimes more general points of principle, which may need some interpretation. One section deals specifically with representatives but it is important for representatives to be familiar with all of the Code, as many of the other sections are highly relevant to their work.

Promotional material

There are extensive and detailed requirements relating to the content of promotional material - advertisements, mailings, details aids etc. The overriding principle is that every piece of promotional material must be accurate and balanced, and should not mislead the reader in any way. Further, every statement must be ‘capable of substantiation’, which means that there must be data to support it. Companies must have rigorous approval procedures to make sure that all material complies fully with Code requirements.

Representative calls

The principle here is that doctors and other health professionals should not be subjected to unacceptable selling techniques. The Code covers the timing and convenience of calls, and prohibits offering any sort of incentive to see a representative. The principle which applies to written material - that it should be accurate, balanced etc - applies equally to everything that is said during a call.

Gifts to health professionals

The principle here is that there must be no suggestion that doctors are rewarded in any way for writing prescriptions. Low value (up to £6.00) giveaways are allowed, provided they are relevant to medical practice - pens, pads, tourniquets etc. Donations of items of greater value e.g. medical equipment can be made by companies, but only if this is totally separated from promotional activity - which usually means separated from representative activity.

Sampling

Sampling of medicines is permitted, but only if this is done strictly in line with the detailed requirements of the Code. These cover the number of samples, sample requests and delivery and control of samples.

Meetings

The main requirement for company organised or sponsored meetings is that they must be primarily educational activities, rather than social events. Hospitality can be provided, but it must comply with Code requirements in relation to cost, form and appropriateness to the occasion and to the attendees. Again, the principle is that there should be no suggestion that doctors are being ‘wined and dined’ by pharmaceutical companies and hence being unduly influenced in favour of their products.

Summary

The principles in each of these areas should be easy to appreciate. Less easy is to learn the many ways in which the principles can impact on day to day representative activity. This requires learning the detail of the Code, and also acquiring experience of the Code in practice.

Sources of information

ABPI - Association of the British Pharmaceutical Industry, the industry trade association. www.abpi.org.uk

PMCPA - Prescription Medicines Code of Practice Authority, the independent body within the ABPI which administers the Code. See www.abpi.org.uk/links/assoc/pmcpa.asp

Code of Practice Review - published quarterly by the PMCPA and made widely and publicly available. It contains full details of all complaints and rulings, naming companies involved but not individuals. Copies of the latest issue are freely available by contacting the PMCPA directly.

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