The current issues of both Nature and BMJ (subscriptions required) draw attention to the role of research universities in improving access to medicines in developing countries, emphasizing the work of Universities Allied for Essential Medicines (UAEM), a student organization with chapters at 35 universities in North America. The Bayh-Dole Act, passed by Congress in 1980, made it possible for universities to patent the results from government-funded research and exclusively license them to private sector partners for further development. Technology transfer activities and royalties earned by universities have rapidly risen since then, suggesting that Bayh-Dole has helped ensure that research results are transformed into commercialized products that benefit consumers. But a drawback of many universities' policies is that the medical innovations have not always been affordable in developing countries. This became clear in the case of Yale University's exclusive license of a key antiretroviral drug known as d4T to Bristol-Myers Squibb under terms that restricted generic competition in developing countries, until pressure from student advocacy groups forced Yale and BMS to yield their patent rights. With the entry of generic producers into the d4T market in 2001, prices fell dramatically throughout Africa.
Having followed these issues while I was at Yale during and after the d4T episode, I think there are several steps universities can take to have a bigger (and more positive) impact on global health. UAEM's recent work highlights some of these steps and shows that student advocacy can help steer universities in the right direction.
As UAEM and others have pointed out, universities stand to lose very few royalties by ensuring there is generic production or low-cost supply of the end-product in developing countries, which make up a small fraction of the global market. UAEM has recently issued a consensus statement that urges universities to adopt a range of socially responsible licensing measures for research outputs. For example, in the case of some health-related inventions, universities could consider non-exclusive licensing of the invention in developing countries, thereby allowing generic production and greater access to the invention. The statement also suggests various sensible actions universities could take to facilitate research for neglected diseases. This must be viewed as one part of broader efforts to increase R&D in neglected diseases. Finally, the statement encourages universities to gauge their success in technology transfer by measures that reveal the true impact of a university's research outputs on global health - not simply total licenses issued or royalties earned.
These recommendations are already receiving some support in Congress, as Senator Patrick Leahy has introduced a bill (.pdf) requiring all federally-funded institutions to take steps to make medical technologies available at the lowest possible cost in eligible developing countries. This bill would obviate separate discussions with every university's tech transfer office, which strikes me as its biggest advantage. But whether the specific access-oriented provisions will be applicable and relevant to a wide range of health-related innovations remains to be seen.
Socially responsible technology transfer is receiving attention right now at several universities and once again at Yale, where the promising new antiretroviral drug Ed4T has been licensed to an industry partner for development. The consensus statement shows how universities can play an important role in improving global health - it has already been signed by numerous organizations and global health experts, and others can sign on at UAEMâ€™s website.