Complying with the ABPI Code - Promotional Material

Before any material is given to you to use, it will have been approved and certified by senior members of your company to make sure that it complies with the Code. The following is intended to give you an understanding of the points which will have been considered. It is NOT intended to be a guide to help you to produce your own material.

Content

Every statement must be:

• consistent with the SPC - in terms of e.g. indications, dosage, patient population, contra-indications, adverse events
• accurate
• balanced e.g. presenting the results of one study in which your product was superior to a competitor product would not be balanced if there was no mention of four similar studies which showed that the competitor product was superior to yours.
• up to date
• not misleading - one of the most difficult areas in the Code as it depends very much on interpretation.
• capable of substantiation i.e. supported by data, usually published references or unpublished data referred to as ‘Data on File’

Certain types of statement are not permitted:

• hanging comparisons i.e. a comparison where it is not clear what is being compared
• superlatives - unless they can be substantiated by data.
• exaggerated claims - claims for a 'special quality' of a product which cannot be substantiated e.g. "Unique", 'the drug of choice'
• "safe" (and related words e.g. safety) must not be used without qualification. ‘well tolerated’ and ‘tolerability’ are often used instead.
• ‘New’ is permitted only for 12 months from first marketing in the UK.

Comparisons

It is acceptable to make comparisons with other companies’ products, provided they follow all the above rules. Statements must not be disparaging - i.e. no ‘knocking’ copy - and it should never be implied that another product is unsafe.

Particular care has to be taken with cost comparisons to ensure that these are fair.

All of the above applies also to:

• Quotes - as far as the Code is concerned, quotes are judged in the same way as any other statements, so you cannot say something in a quote that you cannot say out of quotes. Quotes can only be used with the permission of the author.
• Graphs and figures
• Artwork

Finally, all promotion must recognise the special nature of medicines and the professional standing of the audience and must not be likely to cause offence.

Prescribing Information (P.I.)

All promotional material (with a few specific exceptions) must include P.I.

P.I. is exactly what it says - information needed for prescribing. It is a brief summary of the relevant parts of the SPC but P.I. and SPC are not the same thing - the P.I. must include the cost, which is not in the SPC.

P.I. must be part of the promotional piece not separate from it. The only exceptions to this, when P.I. may be given separately, are reprints, exhibition stands, audio-visual material and interactive data systems. If you are using these, you must follow the instructions you are given about how to provide P.I. - and make sure that it is P.I. you provide, not the SPC.

Use of promotional material

Material which is acceptable for one group, may not be acceptable for another so you should give a promotional piece only to its intended audience. Your company should instruct you about who should receive each piece. You should also follow instructions about how to distribute a piece e.g. by mail, by hand.

As even slight changes to a piece can mean that it no longer complies with the Code, you must not alter material in any way e.g. by writing on it, highlighting it or photocopying it.

Producing promotional material

DON’T!

As all promotional material must comply fully with the Code and must be certified, it is not acceptable (or practical) for you to produce your own material.

Be aware that this also applies to Material produced for you by someone else e.g. invitation letters from the chairman of a meeting

‘Promotional material’ includes letters (see above). Make sure you know your company’s policy on this.

Reprints

Unrequested reprints can be given only if they have been refereed and only if the content complies fully with the Code. You should only use reprints authorised by your company and in the way you are instructed.

P.I. (not the SPC) can be provided with a reprint as a separate document. The easiest way of doing this is to provide another piece of promotional material including P.I. with the reprint.

A photocopy of a paper is viewed in the same way as a reprint of a paper.

Do not photocopy any paper which has been given to you for personal training purposes only.

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 - note a copy of the current Code is available to download in pdf format.

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.