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The way that drug companies hire and reward doctors for consultancy work is to be regulated in the United Kingdom for the first time under new rules laid down by the British drug industry’s trade association.
The revised code of practice from the Association of the British Pharmaceutical Industry bars drug companies from offering “token consultancy arrangements” that are used “to justify compensating health professionals.”
Consultancy work must be covered by a written contract that lays out the services involved, it says, and remuneration should reflect fair market value. Companies should not engage more consultants than they need, says the new code.
Industry members are also “strongly encouraged” to include clauses in consultancy contracts requiring consultants to declare links to the company whenever they publicly discuss issues concerning it. The code encourages drug companies to renegotiate existing contracts to include such a disclosure clause.
The new rules also require for the first time that companies register details of ongoing and completed clinical trials.
Other changes include tightening the rules on provision of sample drugs and new rules on companies’ relationships with patients’ organisations. Companies are also required to set “realistic” targets for pharmaceutical representatives, so as not to encourage unethical behaviour.
The rules on hospitality sponsored by the industry are strengthened. While the previous rules barred companies from holding events at “venues that are renowned for their entertainment facilities,” the new rules stipulate that “companies must not sponsor or organise entertainment (such as sporting or leisure events).”
Charles Medawar, director of the industry watchdog Social Audit, said that the new changes deserve “one cheer.”
“They are slouching towards progress,” he added, but he questioned the provision demanding that pharmaceutical representatives should be given realistic targets.
“Just using the word ‘realistic’ is unrealistic,” he said. “How do you define it? Whatever target is set, everyone knows the reality. Whichever representative comes last is likely to lose their job. That’s the target.”
The new code also stipulates that links with patients’ groups must be transparent. A written agreement should explain the objectives and duration of any such alliance and should disclose all funding or important non-financial support. No drug company may demand to be the exclusive sponsor of a patients’ group. Sponsored educational material must disclose the company’s interest in the subject area.
The changes will come into force on 1 July, although companies have until 31 October to comply. The code of practice is policed by an independent body, the Prescription Medicines Code of Practice Authority. The authority hears complaints from rival drug companies, doctors, public bodies, and members of the public. It can also initiate cases on the basis of media criticism of drug companies’ behaviour.
Sanctions can include an audit of the company’s compliance with the code; a demand that companies withdraw advertisements and publish corrections; and, in serious cases, publication of the finding of a breach of the code in the medical press, often the BMJ and the Pharmaceutical Journal.
Amendments to the Code of Practice for the Pharmaceutical Industry is at www.pmcpa.org.uk/files/sitecontent/Code_changes.pdf.