New developments in biotechnology : U.S. investment in biotechnology.

  • United States. Congress. Office of Technology Assessment.
Date:
1988
Catalogue details

Licence: Public Domain Mark

Credit: New developments in biotechnology : U.S. investment in biotechnology. Source: Wellcome Collection.

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    Collaborative efforts in biotechnology pose spe- cific problems for each group of participants. A recent survey found that faculty receiving indus- try funds are much more likely than other bio- technology faculty to report that their research has resulted in trade secrets and that commer- cial considerations have influenced the choice of research projects. In another study, 40 percent of faculty with industrial support reported that lays in publication. For industry, the major issue is whether such collaboration will prove fruitful and hasten the development of new products and processes. The nature of the agreement—specifically, who nego- tiates the contract and how property rights are assigned—plays an important role in the process and is, therefore, a major concern for companies entering into such agreements. Added to those uncertainties is the great varia- tion among collaborative agreements. Despite those variations, universities can take several steps when negotiating collaborative agreements to maximize the benefits to all parties and minimize potential risks. Those steps include specifying the scope of the agreement (the research area to be supported and the commitment expected from faculty); maintaining control over the selection, methodology, and review of the research to be undertaken; detailing the sponsor’s responsibili- ties; and spelling out in advance guidelines on pro- prietary information, publication requirements, patent rights, and income. Apart from continued funding of the academic research that often sets the stage for such collaboration, the mechanics of Federal monitoring of such relationships are not without problems. Any funding source has the potential to shape the research agenda and influence those who carry out the work. A history of Federal programs, dating from the Morrill Act of 1862 that estab- lished the land grant colleges, indicates how universities can be shaped by outside forces. While many early fears about the influence of industrial sponsorship of biotechnology research in univer- sity laboratories have not been borne out, the sit- uation warrants monitoring. There remains suffi- cient concern about the long-term effects of such funds on research agendas, secrecy, conflict of interest, and student education. Opportunities for Development There is tremendous variation in the way that States and the Federal Government define and account for biotechnology spending. Also, there is no single model by which industry funds research in the field, nor is there a common ap- proach to the carrying out of commercial devel- opments of biotechnology products. At the same time, each sector affords significant opportuni- ties to foster growth in the field. At the Federal Level The activities of the NIH determine to a large extent the nature of Federal support for biotech- nology. In recent years the White House and others have increasingly pressured NIH to expand its mis- sion and provide support for more applied re- search. In 1986, an NIH committee began to draft guide- lines that would permit companies unprecedented access to NIH resources. The guidelines, written in response to the Technology Transfer Act of 1986 (Public Law 99-502), give companies exclu- sive licensing rights to the fruits of government- sponsored research and encourage scientists to seek commercial applications for their work. This opening of the laboratory doors to commercial application offers great promise to the biotech- nology industry, which has long relied on work conducted by NIH scientists. Although the NIH investment in biotechnology dwarfs that of other agencies, opportunities to foster growth abound throughout the Federal Gov- ernment. Other agencies, such as the National Sci- ence Foundation, the National Aeronautics and Space Administration, the Department of Energy, and the National Oceanic and Atmospheric Admin- istration, fund basic and applied research in bio- technology. Agencies with diverse missions, such as the Departments of Defense and Agriculture, and those with regulatory missions, such as the Food and Drug Administration and the Environ- mental Protection Agency, fund biotechnology re-