Sarah Houlton

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 reputation.

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."

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 site, 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 company's reputation.