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Stricter new UK industry code of practice launched

Published on 16/11/05 at 03:13pm

The UK pharmaceutical industry is to adopt a new stricter code of conduct to help distance itself from allegations of misconduct and undue influence on prescribers and patient groups.

Industry association the ABPI has published its revised and updated Code of Practice, with a range of new requirements and restrictions on its members, with public 'naming and shaming' for any company found guilty of the most serious breaches of the rules on marketing and communication.

Intent on promoting a proactive public image, the ABPI has never directly linked the review of its self-regulated code to external pressures, but there is little doubt that sustained criticism has been the biggest factor behind the changes.

Chief among these was the Health Select Committee's inquiry into the influence of the industry, which put forward its recommendations for change in April, with the government endorsing some but not all of these new proposals.

The rule changes are numerous and wide ranging, including new restrictions on advertising and promoting products to healthcare professionals and further curbs on hospitality - though none are so strict that they will require a fundamental shift in the sales and marketing strategies in UK companies.

Self-regulation will continue to be conducted through the Prescription Medicines Code of Practice Authority (PMCPA), but this will now react to complaints and deliver judgements much faster, with rulings published on its website.

Andrew Hotchkiss, managing director of Lilly UK, led the ABPI's review of the Code and said: "Expectations of the industry continue to change, both positively and negatively," and said a number of high profile cases and withdrawals had increased scrutiny on the industry.

The ABPI also conducted an in-depth consultation with stakeholder groups, and said the new measures should reassure them that industry self-regulation can continue to be an effective system.

"The ABPI Code of Practice has been the gold standard for pharmaceutical industry regulation throughout the world for many years, and our aim was to ensure that it continued to be strong and effective as well as fully meeting all the changes and requirements that have occurred since the last review," said Hotchkiss.

The changes

  • Patient safety and side-effect reporting will be reinforced with all printed promotional material now carrying prominent information about reporting adverse drug reactions
  • Tighter definitions on promotional aids, hospitality and payments for travel and expenses will come into force
  • Companies will have to declare which charities and patient groups they provide funding to
  • The number of advertising pages allowed at launch and a new ceiling on mailings will be introduced. All promotional competitions will be banned, having been judged to cheapen the nature of the clinical communication
  • The self-regulated Code will be administered faster - decisions on complaints and sanctions (where necessary) will be made more quickly
  • Promotional materials or activities ruled in serious breach of the Code may be suspended in some cases
  • Results of the most serious cases will be advertised in the medical and pharmaceutical press to provide a 'naming and shaming' sanction

Significantly, the new changes will be brought in alongside a much stricter policing of advertising and promotion by the government's medicines watchdog the MHRA.

The MHRA is to start pre-vetting all advertising materials and claims before the launch of a new product, which it hopes will head off any problems later on.

Jeremy Mean, the senior policy manager at the MHRA, who oversees the new policing measures welcomed the industry's new code.

"The control of medicines advertising in the UK is based on a long-established system of self-regulation supported by the statutory role of the MHRA.

"The MHRA warmly welcomes the new code, which includes positive changes to enhance patient safety to ensure that the code remains robust and rigorous."

The MHRA, PMCPA and the ABPI have also signed a joint memorandum of understanding to clear up where self-regulation ends and statutory monitoring begins.

External links:

The new ABPI Code and the joint memorandum of understanding are available on the PMCPA website at: 

http://www.pmcpa.org.uk/

 

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