New Prescription Debated For Biotechnology Policy

Two years ago, when Harvard and decided against entering the genetics business with one of its professor, a host of questions were raised that remained unanswered.

How could Harvard most effectively translate its knowledge into useful products Should the University grant exclusive privileges to private companies that sponsor research in Harvard labs? What safeguards are needed to preserve academic freedom, given the desire of some outside firms to fund only those projects that will results in marketable items?

In recent months, as continuing cuts in federal grants have intensified efforts to forge closer links between industry and universities, a group of Harvard officials have begun trying to tackle the many questions of technology transfer. "Their discussion will likely produce--by the end of the current academic year--the first set of formal guidelines for industrial sponsored research at Harvard, settling several issues that until now have been a recurring source of controversy.

According to a mid-December draft the most recent of several that have emerged since last spring the rules spell out proposed policy in four major areas conduct of research, discussing criteria for accepting grants motivation for research, including conflict of interest rules for Faculty members, quality of research covering the review and evaluation of projects and the commercial applications of research defining the touchy issues involved with patenting and licensing "any invention deriving from university-based research."

The new guidelines will affect any future agreements that Harvard makes with firms interested in biomedical and DNA research, which has prompted a variety of new drugs and other discoveries with wide-ranging potential for fighting disease.

"The whole thrust of this policy is to make technology transfer policy, to take innovation here and get it turned into things that can benefit the public," says Steven H. Atkinson '67, executive secretary of the University Committee on Patents and Copyrights, which was formed in the mid-1970s to coordinate Harvard's ties with industry.

While income from such arrangements constitutes less than 5 percent of the University's total research budget, officials note a continuing trend towards such arrangements, as well as several new Harvard initiatives to attract funds from the private sector.

Last year, Harvard received about $4.5 million from its corporate research contracts, supplementing approximately $100 million in government research funds that are handled according to a different set of rules, dating back to 1975.

The first hint of the now-booming industrial interest in the biotechnology field came in 1974. When Monsanto agreed to give the Medical School $23 million over 12 years in exchange for exclusive licensing rights to any product developed under its funds.

Since then, two-way research pacts with private industry as opposed to outright gifts, with no strings attached have been handled by the University on a case-by-case basis. Without a consistent policy, officials say, this approach has resulted in many hours of complex discussions regarding principles that shouldn't be subject to negotiation.

One of the more controversial issues relates to the "prospective granting of executive licenses," which officials traditionally have been reluctant to award because they fear that companies will hold onto licensing rights without producing any products, resulting in possible competitive advantages for the firm but subverting Harvard's long-standing commitment to serve the public interest through encouraging the commercial development of research innovations.

In response to these concerns, the guidelines state: "When one does not know what the invention will be, one cannot demonstrate in advance that an exclusive license will be needed nor that the sponsor will be able to develop it effectively Accordingly, prospective exclusive licenses should be required to give evidence of their willingness and ability to develop and commercialize the kinds of products or processes likely to develop from the research."

"It's just become necessary to have these kinds of guidelines in order to conduct our affairs in any kind of orderly fashion. Otherwise, everything that we look at has no precedent," says Atkinson, who helped draft the guidelines based on discussions with Harvard researchers, potential sponsors, and ranking administrators.

While Harvard is one of the first universities to set down firm guidelines for its conduct with industry, most of the nation's major research institutions have begun similar discussions, building upon an informal set of general principles that President Bok played a key role in drafting last spring.

Bok has also contributed his views to discussions of the new guidelines, according to Paul C. Martin, dean of the Division of Applied Sciences and chairman of the year old Committee on Technology Transfer, a group of professors in charge of the guidelines.

While the Technology Transfer body belongs to the Faculty of Arts and Sciences, the guidelines have been disseminated to all of Harvard's faculties which are now in various stages of discussing the rules in the hope of gaining a University wide consensus a rare feat considering the different needs and desires of various disciplines.

While most officials are optimistic about getting formal approval of the guidelines form the faculties this spring. Martin and others acknowledge potential snags at some of the graduate schools. A loss of universal support, however, should not diminish the underlying effect of the rules, which officials hope will be to attract and solidly a number of possible agreements.

With a firm policy, says Atkinson, "it might be possible to do a much broader range of things."