Balancing profit and principle

In the last three decades, discoveries by academic researchers have become an important and lucrative source of income for the universities where they work. Yale itself has earned as much as $33 million a year from drugs and other patented innovations developed in its laboratories. But now Yale and other universities are taking another look at the adverse effects that zealous patent protections and high prices may have on global health. Last fall, these universities and the Association of University Technology Managers (AUTM) signed on to a statement of principles that they hope will allow poor countries to reap more benefits of health-related research.

“As universities, we have a special social contract with society that we have to fulfill, and we see this as being part of that,” says Jon Soderstrom, managing director of the Office of Cooperative Research, who is also the immediate past president of AUTM.

Yale had taken some steps in this direction before the agreement. In 2001, under pressure from activists, the university and Bristol-Myers Squibb agreed to make the antiretroviral drug Zerit available at a low cost in Africa. More recently, ophthalmology professor M. Bruce Shields licensed a glaucoma-treatment device to a company under humanitarian terms. Some companies are taking similar steps; notably, GlaxoSmithKline has announced it will share intellectual property and reduce prices in developing countries. “We’re seeing a series of changes that hopefully in the next three to five years will create a new normal,” says John Wilbanks, an executive with Creative Commons, an intellectual-property nonprofit not involved in the declaration.

Technology transfer—the process of turning research into products—in the United States surged in 1980 after the Bayh-Dole Act, a law that allowed federally funded researchers to patent and license their findings for commercial development. The law has been credited with spawning the biotech industry. But it has also been criticized for shrinking intellectual exchange and sparking legal battles over lucrative pieces of biotech territory. This can raise prices and may damp down innovation, which especially hurts poor countries.

To address these problems, signers will consider ways to channel biotech to the developing world—for example, abandoning patents in developing countries; urging licensees to adopt tiered prices; and promoting research into diseases like malaria. The statement also calls for socially responsible measurements to gauge the success of a discovery: it’s one thing to keep track of revenues earned and patents secured, but no one yet knows how to quantify the social good that results when scientists share stem-cell lines or gene-expression data.

Figuring out new metrics is only part of the hard work that faces signers. They will have to hash out definitions, come up with legal strategies, and develop new standards for licensing. The statement of principles is a signal of good intent, says Wilbanks, and will create space to begin figuring out hard questions, “but the devil’s going to be in the details.”