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The 2009 PhRMA Code on Interactions with Health Care Professionals

By Eric H. Sussman and Adrienne Gonzalez
December 16, 2008

In a continuing effort to provide the latest, most accurate information to physicians, many pharmaceutical manufacturers have been facing a growing public perception that their interactions with health care providers were inappropriate ' or in some cases even unethical. Seeking to remove any appearance of impropriety and reinforce the industry's mission of providing essential medical information, the Pharmaceutical Research and Manufacturers of America (“PhRMA”) recently issued a revised version of its Code on Interactions with Healthcare Professionals that took effect on Jan. 1, 2009 (“revised Code”). The revised Code imposes new “voluntary” restrictions on gifts, meals, distribution of educational items, sponsorship of conferences, and consulting agreements. It also sets forth strict new compliance requirements mandating that chief executive officers and chief compliance officers certify that their companies are implementing policies and procedures designed to foster compliance with the revised Code and verifying the existence of these policies and procedures through periodic outside audits. PhRMA's stated goal for the new Code is to promote “the highest ethical standards as well as all legal requirements.” 2009 PhRMA Code on Interactions with Healthcare Professionals, available at http://www.phrma.org/code_on_interactions_with_healthcare_professionals. Nevertheless, companies should be aware that by raising the bar for the industry, they may be taking on additional legal duties and litigation risks. Government regulators and plaintiffs' attorneys will inevitably take aim at these more restrictive standards and target those companies that fail to meet them.

The impact of the revised Code on a company's business practices will require a careful analysis and action plan to be successful. Failure to comply with the revised Code may have broad implications in terms of regulatory enforcement, product liability litigation and even consumer protection issues. In-house counsel and outside counsel must assess the criminal and civil implications of the revised Code and craft practical policies reflecting its principles. Any analysis should consider the question of how the revised Code might be used against the company in legal proceedings. However, the analysis should also include a discussion as to how the company can use the revised Code to its benefit in potential litigation. If implemented properly, these updated guidelines can help companies protect themselves against unwanted attention from state and federal regulators, as well as the usual character attacks employed by plaintiffs in civil litigation.

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