The issue of who owns a cell line—the human source of the original tissues and cells or the scientists who derived the cell line from them—has caught the fancy of two influential legislators. Sen. Albert Gore (D-Tenn.), vice chairman of the Congressional Biomedical Ethics Board, said that present confusion over the issue "could impede important research." He thinks legislation may be required, and would like to see it considered before Congress adjourns in 1988.
Rep. Robert Roe (D-N.J.), chairman of the House Science, Space and Technology Committee, seems less certain of the need for legislation, but has strongly urged extensive discussion.
The legislators made their remarks in tandem with the release late last month of a report, "Ownership of Human Tissues and Cells," from the Congressional Office of Technology Assessment.
Despite the report and Congressional interest, there appears to be no great demand among scientists for resolution of the ownership question. Robert J. Levine, professor of medicine at Yale University and a member of the working group for the report, said that most researchers are unaware a problem exists, although a small number "really wonder whether their entitlements will be questioned." Another member of the working group, Joseph G. Perpich, who was recently named vice president at the Howard Hughes Medical Institute, said he thought the report would heighten sensitivity to the issue, particularly among industry researchers.
The study was spurred by recent litigation. The best known is a 1984 suit brought against UCLA Medical Center and researchers there by John Moore, a hairy-cell leukemia patient whose spleen provided the original source for the "Mo" cell line. In court and at a Congressional hearing, Moore argued that he was entitled to share in profits derived from commercial uses of the cell line, which the university had patented. A judge dismissed Moore's claim, but the case is on appeal.
The OTA report pointed out that paying donors for their tissue, plus the necessary record-keeping, could be costly. "These costs could add significant burdens to the process of developing biotechnology products from human materials," the report warned.
OTA says four issues need to be addressed:
- Should the government permit commercialization of human tissues and cells?
- Should it modify the commercialization of products derived from such tissues?
- Are the present Guidelines for the Protection of Human Subjects, issued by the Department of Health and Human Services, adequate to protect tissue donors?
- Is present practice adequate to ensure that researchers disclose their potential research and commercial interests in patients?
Roe has asked HHS to respond to the report within six months.