ABPI releases new Code of Practice

Details of the revised ABPI (Association of the British Pharmaceutical Industry) Code of Practice, which comes into effect on 1 January 2006, have been released.

All changes have been agreed following consultation with a wide variety of stakeholders, including professional bodies representing doctors, pharmacists and nurses; patient advocacy groups; and the MHRA (Medicines and Healthcare products Regulatory Agency).

The Code, which governs the UK-based pharmaceutical industry's relations with healthcare professionals and other stakeholders, has been the subject of a 'major review', with the central changes coming in the areas of patient safety, promotions targeted at health professionals, advertising and complaints procedure.

All printed, promotional material will now have to include 'prominent information' about reporting adverse drug reactions, while 'further definition and restrictions' are being applied on what can be provided to health professionals in the way of promotional aids, hospitality, subsistence, travel, and accommodation: 'No gift, benefit in kind or pecuniary advantage shall be offered or given to members of the health professions..as an inducement to prescribe, supply, administer, recommend, buy or sell any medicine'. However, the Code does allow: 'Promotional aids, whether related to a product or of general utility..provided that the promotional aids are inexpensive and relevant to the practice of their [the professional's] profession or employment'.

Relationships with patient groups and the provision of information to the public are given greater attention: The ban on advertisement of prescription only medicines to the general public remains, and it is asserted that 'statements must not be made for the purpose of encouraging members of the public to [seek] a specific prescription only medicine'.

Pharmaceutical companies are allowed to 'work with patient organisations, but must ensure that their involvement in a scheme is 'made clear', and that any requests by members of the public for advice on personal medical matters are refused and directed towards his/her health professional. They must also now make public, by means of information on their website or annual report, a list of all patient organisations to which they provide financial support, and a written agreement must be in place with every organisation spelling out exactly the terms of the relationship and funding of every significant activity or ongoing co-operation.

There is also a reduction in the permitted number of pages of medicines advertising and 'an outright ban on all promotional competitions'.

The complaints procedure is being altered in hopes to make it 'more transparent', with various moves being put in place to speed up the process of ruling on a complaint and imposing sanctions. A company accepting a ruling of the Code Panel will be given only five working days, instead of the current 10, to stop use of the material or activity; which, if found to be likely to 'prejudice public health or safety, or be a serious breach of the code' will be suspended even if an appeal is planned. More serious cases may also be advertised in the pharmaceutical or medical press.

'As well as the changes to the code itself, we want to ensure that more people and organisations know about it, its provisions and understand how it works,' said the president of the ABPI, Vince Lawton. 'With this in mind, we are planning to create a new communications post within the Prescription Medicines Code of Practice Authority (PMCPA), which administers the code, and there will be a major campaign in the new-year to ensure that the code has as high a profile as possible.'