Pharma companies' relationships with doctors are being tightened in the United Kingdom, after a major overhaul of the Association
of the British Pharmaceutical Industry's Code of Practice. First introduced half a century ago, the code governs the way pharma
interacts with doctors, patient support groups, and other stakeholders.
The last big review took place a decade ago. The recent review was designed partly to bring the code in line with the current
regulatory framework, and more importantly, to address some of the issues that are perceived as damaging to the industry's
The new code, which went into effect January 1 (a four-month phase-in period is being given to companies to update promotional
material for doctors), is the result of a yearlong consultation process. Stakeholders ranging from regulators to prescribers
to pharmacists were involved in the process. "The stakeholders told us it was important it's not just a rule book," says Andrew
Hotchkiss, managing director of Lilly UK and chair of the review group. "It must talk about [the companies'] responsibility
to act in the patient's interests."
Similar to tales from the United States, stories in the United Kingdom of doctors being treated to lavish hospitality have
done the industry's reputation no good. The code now stipulates that pharma's use of luxurious venues (or those renowned for
their entertainment facilities) to host doctors are banned. And any promotional gifts that drug reps give to health professionals
or their administrative staff must be cheap (the limit is around $10) and relevant to their profession. The code claims such
items are more likely to be acceptable if they benefit patient care.
In addition, all promotional material must now include "prominent" information about adverse event-reporting mechanisms. The
UK government is extending its Yellow Card scheme for reporting adverse events: Patients—not just doctors—can now report these
themselves. This will keep marketing departments busy, as all promotional materials that companies produce for their drugs
will have to be changed.
"Companies will also have to ensure their staff are trained in pharmacovigilance requirements," says Heather Simmonds, director
of the Prescription Medicines Code of Practice Authority (PMCPA), the body that implements the code.
Medicines and Healthcare products Regulatory Agency (MHRA), a UK regulator, is now taking a much more active role in the advertising
of medicines to doctors, including pre-vetting launch promotional materials for new drugs.
Another big change aimed at increasing transparency comes in the area of drug companies' relationships with patient support
groups. Many of these groups receive hefty donations from those companies whose medicines treat the conditions from which
their members suffer. Pharma companies will now have to make public on their Web sites or in their annual reports those patient
organizations they fund.
Although companies and patient groups are often open about their relationships, it's not always the case. Indeed, this was
one of the concerns raised in the House of Commons Health Select Committee's report last April ("Iron Fist," Pharm Exec, May 2005). The report cited a Health Which survey from 2003, which found that just 32 of 125 patient organizations listed donors on their Web sites.
Sanctions against those companies that break the rules have been beefed up, too. Serious offenders can now be "named and shamed"
with advertisements in the pharma and medical press. And brief details of ongoing cases will be posted on the PMCPA's Web
http://www.pmcpa.org.uk/, where the full text of the Code of Practice can also be found. Simmonds says that, on average, PMCPA deals with a few more
than 100 breaches of the code every year, of varying degrees of severity. Last year, there were 120 cases; in 88 the company
was found to be in breach, mostly for claims made about their products in leaflets left with doctors, or in advertisements
in medical journals.
The review group felt fines would be less effective—a fine, however large, is much less of a deterrent than a threat to a