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All things Pharma

A B P I

Introduction The Association of the British Pharmaceutical Industry (ABPI) is undertaking a major review of the ABPI Code of Practice. The Code covers pharmaceutical company promotion of prescription medicines to healthcare professionals in the UK, as well as the provision of information to the public. It aims to safeguard the interests of patients and to ensure a responsible and ethical approach to such activities. The ABPI Code of Practice was established in 1958. The principle of selfregulation is also enshrined in European law. The Code of Practice is updated frequently, and periodically there are full reviews. The last major review was held in 1993. Since the last major review, there has been considerable reform to the NHS. It is clear that more stakeholders are becoming involved and empowered within the healthcare arena, and there is a need to ensure that the Code of Practice remains relevant and appropriate to its purpose. As part of the current review, the ABPI has been actively soliciting views from a variety of organisations. A number of bodies have been approached directly, including public bodies such as the Medicines and Healthcare products Regulatory Agency, professional bodies, consumer organisations, and patient advocacy groups. Through the ABPI website, views have also been sought from all groups or individuals who might wish to provide input. The ABPI invited comments on the following points: • awareness of and use of the Code of Practice • the relevance of the Code in the current NHS • the quality of promotional activity by the pharmaceutical industry • the effectiveness of the Code, including complaints, procedures and sanctions • how the Code might be updated/improved • how well the prescription pharmaceutical industry is perceived. Responses By 17 March 2005, 21 organisations and individuals had responded to this consultation exercise. Responses were received from: • professional bodies representing doctors, pharmacists and nurses, including three of the royal medical colleges • five patient advocacy groups • individual healthcare professionals • the Task Force on Medicines Partnership • a healthcare campaigning organisation • a writer on health issues and the pharmaceutical industry. In summary, the main comments were as follows: • The Code has an important role in setting standards of good practice, and accountability for the pharmaceutical industry was mentioned. • It was suggested that there could be more representation from patients, members of the public and the healthcare professions. • The current procedure is mainly complaints-driven. There could be a more proactive process for monitoring advertising and promotion to identify possible breaches. • Increased sanctions could be imposed on companies for breaching the Code. • It appears that the Code and the procedure for making complaints are not sufficiently well known by healthcare professionals and others. There should be more publicity about the Code. • There were several comments suggesting that the Code should cover companies’ activities with regard to the supply of medicines. • The introduction to the Code of Practice states that ‘It is a condition of membership of the ABPI to abide by the Code in both the spirit and the letter.’ Further clarification of the spirit of the Code may be needed to ensure that companies’ activities meet appropriate standards. • The Code requires that two people must certify promotional material, one of whom must be ‘a registered medical practitioner or a dentist’. It could be appropriate to extend the list of primary signatories to include pharmacists. • Differing views were expressed about promotional items and gifts provided by pharmaceutical companies. Some responses questioned the appropriateness of gifts, and some concern was expressed about hospitality provided by pharmaceutical companies at meetings. It was suggested that the Code could provide clearer guidelines on the placement of staff sponsored by industry within the NHS. • There were many comments suggesting that the Code could allow pharmaceutical companies to provide more information about medicines to patients, and particularly to patient support groups. Such information should be factual and should not be promotional in nature. Alternative proposals There were suggestions that it might be more appropriate to have an independent body regulate promotion by the pharmaceutical industry. In addition to the Code, the pharmaceutical industry is of course covered by UK law, which is administered by the Medicines and Healthcare Products Regulatory Agency. Next steps The responses from stakeholders received during this consultation process have been of great value in the review of the Code of Practice and its operation. The findings will be used together with input from other stakeholders interviewed by an independent market research company and from pharmaceutical companies. The next step is to assess all the stakeholder feedback, and for proposed changes to be drawn up. It is anticipated that the new Code of Practice will be agreed before the end of the year, to come into operation on 1 January 2006. Acknowledgements The ABPI wishes to thank all those bodies and individuals who responded to the public consultation.

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