Urging Global Access for Medical Breakthroughs

Selim Unlu and his students research biosensor technology that could help doctors in remote areas quickly detect viruses for hepatitis and biomarkers for Alzheimer’s.

But making those breakthroughs will involve more than great research by Unlu, a College of Engineering professor of electrical and computer engineering, and his collaborators. It will also probably require a licensing agreement with a biotech firm that agrees to help — and forgo a bit of profit — by allowing cheaper generic production of these discoveries in the world’s poorest nations.

Researchers are now realizing that top-notch science is just part of making world-changing discoveries. The rest is in the fine print.

A growing student-led movement, including a contingent from Boston University, is pushing universities to craft licensing agreements with private industry to ensure that essential medicines and diagnostics get to the developing world. There’s resistance, or at least sluggishness, to widespread dissemination of generic drugs that might cut into profits. But global access advocates say these restrictions would cost universities and their private partners very little, especially compared with the suffering that could be alleviated.

Currently, most universities give private partners developing university research the right to license and sell drugs, diagnostics, or other products that result from the work. But this can make lifesaving drugs and technology unaffordable in poor nations.

For the past few months, the BU students have been circulating an online “statement of support” for university-wide global-access licensing. On May 6, Andrei Ruckenstein, a College of Arts & Sciences professor of physics and the University’s associate provost and vice president for research (who has not signed the statement of support, but expressed strong interests in its goals) will speak on the topic at an event on the Medical Campus on May 6, dubbed by BU students as Global Access to Medicine Day.

“We need to get this on the radar screen of the University Council and the Board of Trustees,” says Alexander Lankowski (MED’12), one of the BU students leading the effort. “We want to be able to show there’s broad support for this and that scientists do care about where their research is going.”

Licensing policies became an issue at universities in 2000, after Yale University research led to the development of an important HIV drug developed and marketed as Zerit by Bristol-Myers Squibb. That year, Doctors Without Borders put Zerit on a list of essential medicines for the developing world. First-year Yale law student Amy Kapczynski, now an assistant professor of law at the University of California, Berkeley, School of Law, took up the cause and used the media (first the student newspaper, then the New York Times) to pressure Yale and Bristol-Myers to allow generic production of Zerit in South Africa, where the HIV infection rate was about 25 percent.

By June 2001, Bristol-Myers had agreed “not to sue” a South African manufacturer that wanted to make a generic version. The same year, Yale students founded Universities Allied for Essential Medicine (UAEM), which now has about 50 university chapters internationally, including one at BU.

A goal of the movement is to foster low-cost distribution of drugs and diagnostics in certain markets. Acknowledging the complexity of patent law and licensing contracts, advocates are flexible about how such access is achieved. Johann Bergholz (MED’11), a doctoral student in biochemistry and a global access advocate, also argues that the definition of “essential” medical products should be “as broad as possible,” reaching beyond infectious diseases to treatments for cancer and heart ailments, but not including “lifestyle drugs” like Viagra.

After a few years, says Ethan Guillen, UAEM executive director, what had been a “very loose coalition of students” started having a real impact. In 2007, the University of British Columbia adopted a statement of global access principles for university research. So did Emory University. According to Guillen, similar measures are now being considered at Georgetown, McGill, and the University of California campuses.

Fear of lost profit is part of the holdup. “Any time you start talking about something that could be perceived as taking money away, you’re going to run into some resistance,” says Lankowski. But he contends that the amount of money to be made in the least developed countries is a tiny fraction of drug company profits. Reports by PhRMA, the leading association of pharmaceutical makers, note that about 95 percent of industry sales are made in North America, Europe, Australia, and Japan. By contrast, India, Pakistan, and all of Africa combine for less than one percent.

Global access advocates also say universities aren’t putting much revenue at risk. For example, BU takes in a few million dollars a year in licensing and royalties, well below one percent of its total operating budget, and not all of those products would be classified as “essential” for the developing world.

A more substantial worry for universities, says Kevin Outterson, a School of Law associate professor of law, “is that private-industry research money will go to the university next door, because even though these are minor restrictions, they’re still restrictions.” Outterson, who supports the student effort and is its faculty advisor, says it would be easier for clusters of universities to change their licensing policies in concert.

But even though nearby Harvard and MIT dwarf BU in terms of technology licensing deals, BU students think this university shouldn’t be afraid to be a leader. “We need to set the example,” says Lankowski.

According to their petition in support of global access licensing, drafted in January 2009, “Research discoveries originating in Boston University laboratories and clinics must be patented and licensed with a concrete, effective, and transparent strategy to provide for global access.” Hundreds of people have signed on, Unlu one of the first.

“By taking university jobs, most of us indicate that we are interested in things beyond money,” he says. “Most faculty are interested in seeing their work used for the benefit of humanity.”

BU already has shown leadership on this issue. Ashley Stevens, executive director of technology transfer for BU Technology Development has proposed that licenses his office negotiates should allow generic competition in developing countries, so long as the generics look different enough so they can be tracked if a black market tries to divert them to wealthy nations. However, Stevens notes, if a company comes up with other strategies for increased access and protection of patents, BU is prepared to work with them.

Lankowski says that Stevens, who is also president-elect of the Association of University Technology Managers, is “very forward thinking on this issue.”

But the students want BU to go further. “Our hope is that BU will formally adopt a university-wide global access policy,” says Lankowski, which “should also have some mechanism for transparency and oversight.”

Whether drug and biotech companies will be responsive is hard to say.

“There is a whole spectrum of attitudes about this in industry,” Stevens says. Companies pour hundreds of millions of dollars and a decade or more to bring a new drug or diagnostic to market, and are reluctant to part with any sliver of return on that investment. Some companies, however, have put global access at the core of what they do. California-based Gilead, for instance, allows several drug manufacturers in India to produce generic versions of its drugs, particularly for HIV, now for sale in 95 countries.

Phone calls and e-mails seeking comment from pharmaceutical industry trade group PhRMA were unreturned.

Lankowski says universities, whose mission is discovery for human welfare, should be out in front on this issue. After all, he asks, “What does it say about universities when pharmaceutical companies are taking the lead on this sort of thing?”

The Global Access to Medicine Day event begins at 6 p.m. on Wednesday, May 6, with remarks from Andrei Ruckenstein, followed by a panel discussion. Panelists include Gerald Keusch, Medical Campus assistant provost, School of Public Health associate dean for global health, and director of BU’s Global Health Initiative, Ashley Stevens, and Kevin Outterson. The event is being held in the Hiebert Lounge on the 14th floor of MED’s Instructional Building L, 72 E. Concord St.

Chris Berdik can be reached at cberdik@bu.edu.

Correction: An earlier version of this story implied that Andrei Ruckenstein, BU’s associate provost and vice president for research, had signed the student
statement of support for global access licensing. He has not signed the statement. We regret the error.