The Association of the British Pharmaceutical Industry's (ABPI) Code of Practice was born as a result of the negative reputation of the industry, and a desire to reverse the perception that it has somewhat dubious ethics.
The code covers the promotion of prescription-only medicines in the UK to healthcare professionals and National Health Service (NHS) managers, and does not apply to over-the-counter medications. It aims to ensure that all promotional activities undertaken by members are undertaken in a responsible, ethical and professional manner.
This means that companies are restricted in what they say to their customers and the public, and how they say it.
Communicating with Healthcare Professionals
Doctors and clinicians are the main prescribers of prescription drugs, and therefore are often the people who decide which drugs are used. Healthcare professionals are therefore the main target of pharmaceutical sales representatives. However, the code states that a sales rep may only approach each customer a limited number of times each year, usually no more than three times per year, and that visits must be arranged to cause minimal inconvenience.
The company may provide drug-specific information to customers, and the code states that 'materials must be accurate, balanced, fair, objective and unambiguous, be based on an up-to-date evaluation of all the evidence and must not mislead'. They must also be factual, and any claims must be able to be substantiated.
The days of coercing physicians' loyalty to particular products through gifts or expensive meals or trips are long gone. Companies may invite doctors or nurses to meetings and congresses, or to take part in educational events, but the hospitality must be appropriate. There are restrictions on types of venue that are suitable for meetings, for example, 5 star hotels, or 'resort destinations' are not appropriate, nor are lavish meals at expensive restaurants. In addition, the agenda must be full enough to justify an overnight stay, which means that breaking off early to allow time for sight-seeing is not permitted if the company is effectively paying for this time.
Similar restrictions apply to gifts or inducements. Only promotional aids may be distributed 'provided they are inexpensive and relevant to the practice of their profession or employment'.
Communicating in the Medical Press
Advertising is an obvious way to promote a product. However, adverts for prescription only drugs must not appear anywhere where the general public will see them, therefore drug adverts can generally only be placed in medical journals and magazines. There are also guidelines as to what constitutes an advert, for example, a review article placed in a specialist nurse or physician magazine may be rules as an advertorial if it is deemed too promotional. There are also limits on the number of pages per publication that can be dedicated towards the promotion of one product.
Communicating With the General Public
Another way in which companies may find patient communication useful is to improve diagnosis rates of conditions that are typically under-treated. For example, if a company has a 20% market share in a particular condition, but estimates suggest that only 50% of cases are being diagnosed, a campaign aimed to improve the awareness of the condition within the general public is likely to result in an increase in the number of people being prescribed their drug. This type of communication is allowed within the code of practice only where the name of any drug is not mentioned.
Breaking the Code
The ABPI code of practice is voluntary, and self-regulated, however, there are serious consequences to flouting the rules. Companies are often keen to point out errors made by rival companies, and if complaints are upheld, large fines or even expulsion from the ABPI can follow. In addition, the company will be expected to withdraw the offending materials, and go through the expensive process of revising all their materials. In short, disobeying the code is not worth the consequences.
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