Drug industry's new code criticised for lacking teeth

The pharmaceutical industry published a tougher code of conduct this week after criticism that self regulation was failing to stop the circulation of misleading claims about products. The revised code from the Association of the British Pharmaceutical Industry follows a critical health select committee report in April (BMJ 2005;330: 805).

As evidence that self regulation wasn't working well, the report cited examples of breaches of advertising regulations; cover-ups of negative medical information; and giving misleading information to prescribers. MPs also criticised the long delays taken by the industry to investigate complaints.

As with previous codes, the new code of conduct, to be launched in January, is a voluntary code, without the backing of the law. It covers communication with the public and the promotion of prescription only medicines to health professionals. The main changes include a tightening of rules governing hospitality so that delegates sponsored by companies to attend meetings must only be given economy airline tickets and should not be put up in “lavish” accommodation. The new code stops short of banning four or five star hotels, however.

The code says that all printed promotional material should now include prominent information about reporting adverse drug reactions. The permitted number of pages of medical advertising for a drug has been reduced from three to two pages. There is also an outright ban on promotional competitions because they “trivialise the information about medicines.”

On marketing, companies must make no more than three mailings in the first six months of a drug launch. Each drug has an overall limit of eight mailings a year.

The code promises to speed up complaints procedures and powers to suspend materials even if a company is appealing against a board decision. In serious cases, the association would take out advertisements in the medical press condemning those companies that had broken the code. The code does not, however, introduce fines for companies.

Andrew Hotchkiss, an association board member and managing director of Lilly UK, said, “The key thing for us is the reputation of the industry. ‘Naming and shaming’ is the biggest sanction. At the end of the day any company can pay a fine—whether it be £100[$172; €146] or £10 000 but more valuable is the company's reputation.”

Breaches of the code are dealt with by the industry's Prescription Medicines Code of Practice Authority. Last year the authority considered 120 complaints, mostly from health professionals, and 88 were ruled as in breach of the code, mainly complaints related to printed promotional material.

Some people have doubts over the supposed strength of the new code, however. Ike Iheanacho, editor of the Drugs and Therapeutics Bulletin, said, “This has been heralded as a new dawn in the promotion of prescription medicines and allied activities. But the problem is that the code is fundamentally weak because the ultimate sanction a company faces for breaking it is very limited.”

The ultimate sanction for a company breaking the code is expulsion from the Association of the British Pharmaceutical Industry, and this has never happened. The board has also never required a company to publish a corrective statement. “They can make token changes but the key weakness is that this is regulated by the industry, and so it is written in such a way that it doesn't seriously inconvenience companies if anything goes wrong,” he said.

Professor Andrew Herx-heimer, emeritus fellow at the UK Cochrane Centre, said, “It's a very determined sales job on the new code—just like a drugs promotion. But what does it mean in substance? You need to look at what is missing. This is very competent window dressing but not much has changed at all.”

The health select committee's report, The Influence of the Pharmaceutical Industry, is available at http://www.publications.parliament.uk/.