The UK’s Association of the British Pharmaceutical Industry yesterday unveiled the first thorough shake-up of its Code of Practice for a decade as it strives to improve the image of the sector following several high-profile drug withdrawals and to boost public confidence in the safety of medicines.
And the changes are far-reaching, delving into all aspects of the Code. Safety has taken centre stage, and there are additional requirements with regard to promotional materials, alongside a new emphasis on adverse event reporting by doctors. In the wake of the Health Select Committee’s report on the influence of the pharmaceutical industry, the ABPI and its member companies have agreed on greater restrictions to journal advertising and product mailings, while some non-promotional materials will now need to be rubber-stamped and promotional competitions have been abolished.
While in the UK, direct to consumer advertising is strictly prohibited, and will continue to be, there is a growing acceptance of the role the UK pharmaceutical industry could play in providing credible healthcare information to patients and the public. Richard Ley, spokesperson for the ABPI, told PharmaTimes News Online recently: “We should be allowed to join in the provision of information from which, at the moment, we are the only people excluded!” Although DTC will continue to be banned, the Code provides more details about what exactly can and cannot be provided in terms of information to patients, which the ABPI believes will give clarity to pharmaceutical companies.
Doctors, however, might have cause to look at little po-faced at the new Code: with heightened scrutiny on hospitality, they will now only be able to travel to sponsored medical conferences by economy air, and there will be restrictions placed on venue selection by pharmaceutical companies. “It has to be education that attracts doctors to attend. Having said that, it is a vital part of a doctor’s continuing medical education to be informed about innovative medicines,” said the ABPI’s Director-General, Richard Barker, “and it is striking a balance between this and providing too much or inappropriate information.”
And the ABPI is placing much greater emphasis on the naming and shaming of companies that fail to match its expectations, with additional sanctions to be put into force. It believes a negative image rather than a financial penalty is the greatest deterrent and, should an organisation fall out of line, it plans to announce the fact via public statements and advertising in healthcare journals, as well as the withdrawal of marketing materials, in serious cases.
Andrew Hotchkiss, Chair of the ABPI’s Code of Practice Review Working Group and Managing Director of Lilly UK, explained the need for a revision: “The National Health Service has witnessed many significant changes, including a wealth of new prescribers, and this Code seeks to meet public expectations of the Industry, and to build trust and confidence in the safety of our medicines.” The new Code comes into force on January 1, 2006, and there will be a four-month phase in for the new requirements.