How long should developers of complex biologic drugs be able to sell their products without generic competition? It is a question that has plagued US lawmakers, but one that many agree should not be determined by industry maneuvering.

As Nature Medicine went to press, both the Senate and House versions of the health care reform bill provided 12 years of data exclusivity for these branded 'biologics'—protein therapies produced by cultured cells—to help companies recoup research investments. But President Obama and many of his congressional allies have fought for a shorter period of market protection.

In a paper published in December, Donald Light, a health policy expert at the University of Medicine and Dentistry of New Jersey in Stratford, and his coauthors describe heavy industry influence in determining biologics legislation. Light and his colleagues pored over numerous reports and conducted 16 interviews with key stakeholders to investigate the political route by which the EU established an exclusivity period of ten years beginning in 2004. They concluded that the European Commission's Directorate General for Enterprise crafted the legislation behind closed doors with the help of industry lobbyists, despite vocal opposition from generics companies, consumer groups and member states and without sufficient data showing that the price protection would spur innovation (J. Health Polit. Policy Law 34, 979–1010, 2009).

“This legislation and the lobbying behind it only served to enhance the profits of pharmaceutical companies without any evidence that they benefit patients or society,” Light says.

Jack Calfee, a health economist at the American Enterprise Institute, a conservative think tank in Washington, DC, suspects that the authors “are exaggerating the degree to which industry influenced the discussions” in the European legislature. But even if one accepts the study's findings, he says, the same situation is unlikely to happen across the Atlantic where the US Department of Commerce—the nearest equivalent to the Directorate General for Enterprise—wields far less executive power.

“What they do over there is so different from what's done here,” Calfee says. “Over here, exclusivity is going to be determined by Congress—there's no doubt about that.”