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Harvard Among Six Schools Urging Drug Access for Poor (Update1)

By John Lauerman

Nov. 9 (Bloomberg) -- Harvard University and Yale University are among six schools pledging to encourage companies to give poor countries better access to drugs and medical products stemming from discoveries made on their campuses.

Harvard in Cambridge, Massachusetts; Yale in New Haven, Connecticut; Brown University in Providence, Rhode Island; the University of Pennsylvania in Philadelphia; Oregon Health & Science University in Portland; and Boston University in Boston will release a statement today that will guide how drugs developed by scientists at the schools are licensed to companies, said Kevin Casey, a spokesman for Harvard. Representatives from the six institutions signed the statement after campus groups pushed for policies to make new treatments available at low cost to poor patients.

The statement commits the schools to make “vigorous efforts” to promote global access to drugs through licensing strategies. The six said they will work to include provisions that call for lower prices for drugs to treat AIDS and other diseases that afflict poor countries. The precedent for such collaboration dates to 2002, when Yale and New York-based drugmaker Bristol-Myers Squibb Co. agreed to permit generic production of the AIDS treatment Zerit in South Africa.

“We believe the principles and strategies enunciated in this document will further our shared goal of providing access to the benefits of our medical inventions for the most needy global citizens,” said Yale President Richard C. Levin, 62, in a statement.

Academic Innovation

Academic researchers’ findings provide the technological basis for innovation for almost every biotechnology company, said John Maraganore, chief executive officer of Alnylam Pharmaceuticals Inc. in Cambridge. Prescription drug sales in the U.S. were $291 billion in 2008, according to IMS Health Inc. in Norwalk, Connecticut. Maraganore said he hadn’t known the statement was being developed.

“I’m concerned about this type of action taking place unilaterally for a major source of inventions for the world,” Maraganore said. “I think it’s very important to have a dialogue to get this right.”

School officials want to craft guidelines that encourage drug access for poor nations without dissuading companies from working with university scientists, said Maryanne Fenerjian, Harvard’s director of technology-transfer policy.

Lower Royalties

The schools will also use strategies such as decreasing royalty rates to persuade companies to charge less or allow low- cost generic production of new drugs for poor patients, she said. Techniques cited in the document have already been used by Harvard to help promote access to medicines, Fenerjian said.

“We agree that it’s important that our intellectual property doesn’t serve as a barrier -- and in some cases should be used as leverage -- to help ensure that drugs, vaccines and other technologies reach the developing world,” Fenerjian said in an interview. “But there is no single solution. Every technology is different and every licensee’s capabilities and sensitivities are different.”

An international student group called Universities Allied for Essential Medicines, supported by the New York-based Ford Foundation, has been asking schools for about seven years to help broaden access to drugs.

Harvard’s chapter of Essential Medicines held demonstrations on campus in September to urge increased drug access. Supporters erected giant pill bottles on campus, wore “Say Yes to Drugs” T-shirts and held a fund-raising dance, said Jillian Irwin, a member of the group.

Student Petition

The protesters collected more than 1,000 signatures petitioning Harvard to adopt a licensing policy that would increase access in poor nations. Harvard students also met with Provost Steven Hyman and Harvard School of Public Health Dean Julio Frenk earlier this year to press the issue, Irwin said.

Harvard hired Chief Technology Development Officer Isaac Kohlberg away from New York University four years ago and began expanding the Office of Technology Development to put more campus research to use. The school is trying to raise revenue from new sources after its endowment lost about a third of its value last year, said Michael Smith, dean of Harvard’s Faculty of Arts and Sciences, the school’s biggest division, in a speech in September.

MIT’s Licensing

Kohlberg is trying to catch up with the licensing success of other schools, such as the Massachusetts Institute of Technology, also in Cambridge. MIT granted 67 licenses in the fiscal year ended June 30, and got $66.3 million in royalty income, according to the school’s Web site. In the same year, Harvard sold 36 licenses, raising $12.4 million. In fiscal 2008, Harvard sold 26 licenses and received $21.1 million.

Harvard has already used its contract power to push for increased drug access, Fenerjian said. When the school licensed a tuberculosis vaccine technology in 2007 to Morningside Group, a Hong Kong-based licensee, the company agreed to sell vaccine produced with the approach at affordable prices in developing countries.

Harvard’s licensing officials have been meeting with students for as long as four years to discuss drug access, Harvard’s Casey said. Their involvement, which has become more intense this year, has been “helpful,” he said.

“There’s been a convergence of interest,” Casey said. “The students have constructively engaged in an area that happens to align with one that the administration at the provost level and below has been concerned about.”

Students at the 373-year-old school have scrutinized relationships between Harvard faculty members and industry. Earlier this year, students at Harvard Medical School pushed to require professors to reveal their financial ties to companies before lecturing.

Increased Pressure

Irwin, from the Harvard chapter of Essential Medicines, said the group stepped up pressure on the licensing issue after a February speech by Andrew Witty, chief executive officer of London-based GlaxoSmithKline Plc, the world’s No. 2 drugmaker. Witty said the company would cut prices in the 50 poorest countries, and share patents on technologies that might address health problems in impoverished nations.

Alnylam has licensed a drugmaking technology called RNA interference that stops individual genes from making proteins involved in cancer, nerve disorders and lung infections. The company has agreed, along with Glaxo, to share intellectual property, Maraganore said.

“It’s very appropriate to promote mechanisms whereby medicines become more available in parts of the world where they’re needed,” Maraganore said. “At the same time, it’s critical to preserve the incentives to discover those medicines in the first place.”

Concrete Policy

Since the June meeting, members of Essential Medicines haven’t been invited to participate in the discussions, according to Irwin. Students haven’t seen a draft of the guidelines and don’t know whether they are strong enough to make a difference, she said.

“We’re asking for a concrete policy,” said Irwin, a junior at Harvard who majors in social and cognitive neuroscience. “We want to know the provisions that will be included in different types of licenses, and how this policy will be incorporated into them.”

Schools can’t guarantee that access-promoting provisions will be incorporated into every license deal, said Harvard’s Fenerjian. Schools don’t always have the bargaining power to include such clauses in their agreements with companies, which often pay hundreds of millions of dollars to develop new drugs and are selective in choosing the ones to license, she said.

More schools will be invited to accept the guidelines, Fenerjian said.

“A number of institutions have been willing to be tough and creative on these issues,” Fenerjian said. “Until now, we haven’t had a statement that says this is what we see as our goal, this is what we see as our new norm.”

To contact the reporter on this story: John Lauerman in Boston at jlauerman@bloomberg.net.

Last Updated: November 9, 2009 12:57 EST

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