UK industry code of practice to be reviewed
pharmafile | January 7, 2005 | News story | Sales and Marketing |
The ABPI has announced a major review of its self-regulated Code of Practice, seeking the views of stakeholders on the system which polices industry promotion and communications with the NHS.
The UK industry body has called the review as the pharmaceutical industry battles to defend its reputation against a growing number of critics who say the marketing and promotion of products is out of control.
ABPI spokesman Richard Ley says the code is being looked at now because it hasn't undergone a major review in 11 years, but the industry hopes a strengthened code will head off calls for an independent watchdog or even new legislation.
The Prescription Medicines Code of Practice Authority, which is funded by the industry, deals with complaints from healthcare professionals and rival manufacturers about promotional material, and regularly finds companies in breach of the guidelines.
Companies found to have made the most serious breaches of the code can be subject to audit of their procedures, and can be publicly reprimanded or even suspended or expelled, but this is a rare occurrence.
Most companies found in breach of the code need only pay administrative charges, something which critics say is not a big enough deterrent against breaking the rules.
Medical consultant Dr Joan Barnard said: "The ABPI never said the administrative fines were supposed to be punitive, just a means of funding the system. The fact that these cases are published in the Code of Practice is meant to be the main sanction, but by the time the advert has been withdrawn the advert may well have done its job."
Dr Barnard believes interesting parallels can be drawn from the recent investigations into the General Medical Council's investigation into the Harold Shipman case.
She continued: "The recommendations were actually very critical of the handling of the Shipman case and the Code of Practice needs to compare itself with other self-regulatory bodies."
British Medical Journal acting editor Kamran Abbasi believes fundamental issues need to be addressed in the review.
He said: "If the people who flout the code of practice are never brought to book on it then what is the point of it? The ABPI needs to think carefully about how it is enforcing the code."
Critics believe the review is long overdue, stressing the need for a review of self-regulation as well as the provision of information to the public by pharmaceutical companies.
Wendy Garlick, principal policy adviser in health for consumer magazine Which? said : "Strengthening the Code is to be welcomed. However, the public interest will only be properly protected if the regulations are fully enforced to ensure breaches do not occur. Effective penalties and enforcement is urgently needed."
The ABPI, though, says self-regulation allows continued modification and updating of the code which would not be possible with statutory guidelines.
The findings of the review are expected to be published by the end of 2005, following a three-month consultation with organisations from the healthcare and pharmaceutical community.
The review will cover crucial issues of the code, like recommendations for changes and additions to its clauses, the effectiveness of sanctions, and the practices and processes of other self-regulatory bodies. After which, results will be collated and considered, with the aim of publishing the new code before the end of 2005.
An independent market research company will be approaching regulators like the MHRA, the Advertising Standards Authority; professional bodies, including royal colleges; consumer bodies; patient advocacy groups; trade bodies; and publications like the BMJ and The Lancet, ascertaining their views on the code.
