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Executive Summary

Hearings on ethical and social issues related to gene patenting will be held by the Senate Labor & Human Resources and Judiciary Committees in a compromise with Sen. Hatfield (R-Ore.). In return, Hatfield withdrew a planned floor amendment seeking a moratorium on patenting of genetically-engineered organisms. Hatfield had intended to offer the amendment during debate on the National Institutes of Health reauthorization bill (HR 2507), which the Senate adopted on April 2. Hatfield's amendment would have reconstituted the congressional Biomedical Ethics Board to study ethical and social issues related to gene patenting during the three-year moratorium. The board never got off the ground when created during the 1980s due to disputes over whether members represented a balanced array of positions on issues such a abortion. Addressing the Senate April 2, Hatfield said Labor Committee Chairman Kennedy (D-Mass.) and Judiciary/Patents subcommittee Chairman DeConcini (D-Ariz.) have given "their commitment to hold hearings in both the Labor and the Judiciary Committees pertaining to the issues raised by the patenting of both animal and human life. We will also ask the Office of Technology Assessment to conduct an additional study in this area." Hearing dates have not been set. Hatfield is a force to be reckoned with on such an amendment, combining his powerful position as top Republican on the Senate Appropriations Committee with deeply-held religious and "pro-life" sentiments. The senator has had long-time reservations about the patenting of genetically-engineered animals and had offered legislation to slow the patenting of such animals in 1987. More recently, the Oregon Republican has grown concerned about NIH's patent application for 2,375 complementary DNA sequences. Those applications were filed in November and February ("The Pink Sheet" Nov. 18, 1991). Even so, Hatfield's amendment, which first surfaced on March 30, took NIH bill watchers by surprise. It drew widespread industry opposition and in particular sparked an all-out lobbying effort by the Industrial Biotechnology Association. IBA reportedly had lined up several key members of the Labor and Judiciary committees to oppose the Hatfield amendment in the event that the compromise approach could not be worked out. The Association of Biotechnology Companies also issued an "action alert" to its members requesting them to urge their senators to oppose the bill. Senators received letters on March 31 opposing the amendment from HHS Secretary Sullivan, MD, Patent & Trademark Office Commissioner Harry Manbeck and White House Office & Science Technology Policy Associate Director for Life Sciences D. A. Henderson, MD. The Congressional Biotechnology Caucus also wrote a "Dear Colleague" letter to senators opposing the amendment. Secretary Sullivan asserted that the "moratorium would lead us to forfeit our lead in biotechnology, where patent rights are a key to the large investment needed for product development." Some of the amendment's provisions "represent redundancies," he added, particularly the revival of the Biomedical Ethics Board. The HHS secretary noted that the National Center for Human Genome Research is spending about 5% of its budget for study of ethical and social issues related to the genome mapping project. In his speech, Hatfield said "the decision to patent is more than a technical question of patent-ability. The direction and use of biotechnological research is a question of profound ramifications, one that I believe should not be made solely by Patent Office officials whose primary guide is the century-old patent law." Regarding NIH's gene sequence patent applications, Hatfield remarked that "the very fact that the NIH has applied for the patents raises the specter of removing the building blocks of life from the common possession of us all and shifting them to the private use and profit of researchers or corporations. It is predictable that major biotechnology and chemical companies will increasingly compete for control and ownership of the gene pool." Hatfield asked: "The NIH actions also raise the question of how many genes, cells or body parts are patentable. Is the human body ...simply a biological machine that can be engineered and patented?"

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