Should Generics be 'Trade Dressed' to Boost Patient Compliance?



Pharma IQ
08/02/2011

Is it fair to say that providing patients with generics that look different from their branded counterparts has a negative impact on health outcomes? Would a uniform 'dress code' really be able to improve patient compliance in a considerable way?

Published in a recent issue of the New England Journal of Medicine, a report by Jeremy Greene and Aaron Kesselheim, of Brigham and Women's Hospital, Boston, suggests that federal laws and regulations to protect the unique appearance of brand-name medicines are outdated and could be putting patient outcomes at risk. Under current rules, which outline 'trade dress' requirements, generic drug manufacturers cannot engineer pills to look like their brand-name counterparts.

In their report, the researchers argued that not only can aesthetic differences lead to errors with dosage, but they also threaten to diminish the generic product's clinical effectiveness. "A resurgence of research on the placebo effect suggests that drug appearance can have a distinct functionality," they wrote, adding that packaging and the perceived monetary value of medicines can also influence health outcomes. The solution, as Greene and Kesselheim see it, is to amend intellectual property (IP) laws and regulations from the US Food and Drug Administration (FDA) to allow generics to more closely resemble their branded equivalents.

"Instituting a more consistent and organised system of pill appearance would increase patient adherence, reduce the complexity of medical regimens, reduce medication error, and encourage the rational use of bioequivalent generic drugs," the researchers noted. They argued that while 'trade dress' rules once had public health's interests at heart, they now serve only to restrict manufacturers of generic products. Looking in detail at what constitutes 'trade dress', the authors said it was limited to the aspects of a product's packaging aside from its functionality that make it stand out from the competition.

"To qualify as 'trade dress', an attribute must meet three criteria: it must be non-functional; it must lead to confusion - or deception - if imitated; and it must have a secondary association with the product for the consumer," the report said. Greene and Kesselheim used the example of Coca-Cola's distinctive bottle design, which the US government has historically recognised and protected as a form of IP just like the world-famous brand name itself.

And as the researchers pointed out, maintaining this kind of differentiation has been especially important to big pharma, namely to prevent medicines from being mistaken for one another, as well as to stamp out counterfeit products. They added: "The existence of generic drugs that look different from the brand-name version can have important negative effects on patient outcomes in three key areas - prescription error, medication adherence, and the contribution of the placebo effect."

According to Greene and Kesselheim, a further benefit of brand-name and generic packaging sharing similar appearances could be to "combat the physician's persistent use of, and the patient's preference for, costly brands when generic equivalents are available". While many will agree with the findings that confusion over different drug packaging poses a threat to patient compliance, few pharma professionals are likely to see uniform 'trade dress' between generics and branded pills as a feasible step forward.

Major drug-making firms have invested billions of dollars in the marketing of their products, with a key focus of such efforts being to distinguish them from the offering of rival companies. To create a universal approach to the aesthetics of branding would therefore be no mean feat. It would involve turning tradition on its head and changing how the entire industry thinks as well as behaves, which most would agree paves the way for a whole new set of challenges.