Harnessing the Benefits of Biobanks

Author:

Andrews Lori B.

Abstract

We have a thriving biotechnology industry in the United States. There are over 1,450 biotechnology companies developing diagnostic and treatment technologies in medicine, creating more nutritional foods, and innovating new industrial processes. Yet this $28.5 billion sector of the economy is not without controversy. The “bio” in biotechnology comes from living, biological entities - people, plants, animals, and even bacteria. In the realm of biobanking, people are the source of the raw material for the discovery of genes for research, diagnosis, and therapy, raising a host of issues about rights and responsibilities, fiduciary duties and societal obligations.

Publisher

Cambridge University Press (CUP)

Subject

Health Policy,General Medicine,Issues, ethics and legal aspects

Reference54 articles.

1. 23 Prior to the 1980s, if a university or federal researcher discovered or invented something using federal funds, that advance belonged to the public. The researchers could not personally profit. But with the passage of the Bayh-Dole Act, and the Stevenson-Wydler Act in 1980, and the Federal Technology Transfer Act, in 1986, the rules changed completely. These legal measures were enacted to encourage the commercial development of government-funded research. The Bayh-Dole Act allows universities and non-profit institutions to apply for patents on federally-funded inventions and discoveries and provides significant tax incentives to companies investing in academic research. 35 U.S.C. § 200–211 (2004). The Technology Transfer Act allows researchers in government facilities, including scientists at the National Institute of Health, to patent their inventions, and keep up to $150,000 of the yearly royalties on top of their government salaries. 15 U.S.C. § 3710c (a) (3) (2004). The law allows government researchers to enter into commercial arrangements (known as CRADAs – cooperation research and development agreements) with for profit companies. 15 U.S.C. § 3701–3714 (2004). Overnight, behavior that would have sent federally-funded university researchers to the penitentiary in the 1960s and 1970s – personally profiting from research done on taxpayers' expense – was not only legal, but encouraged. See L. Hayflick, “Novel Techniques for Transforming the Theft of Mortal Human Cells Into Praiseworthy Federal Policy,” Experimental Gerontology 33 (1998): 191–207, at 204. Largely as a result of these legal changes, NIH patent applications increased nearly 300 percent. See S. Krimsky, “The Profit of Scientific Discovery and its Normative Implications,” Chicago-Kent Law Review 75 (1999): 15–39, at 22. But not all political leaders were convinced it was a wise move. Then-Congressman Al Gore argued that the arrangement was akin to “selling the tree of knowledge to Wall Street.” S. Shulman, Owning the Future (New York: Houghton Mifflin Company, 1999): At 114.

2. 35. College of American Pathologists Advocacy, Gene Patents Detrimental to Care, Training, Research, at (last visited December 23, 2004).

3. 36. Phone conversation with Myriad representative (June 2, 2004).

4. 20. In fact, when Menorah Gardens and Funeral Chapels lost an amputated leg of an Orthodox Jewish woman, it made a $1.25 million lawsuit settlement with her daughter. “Orthodox Jews believe that at the end of time, not only will a person's soul be resurrected, but the body as well.... It's important that the whole body, including blood, be buried.” Fitzgerald, H. Jr. , “Woman Awarded $1.25 million in Suit; Funeral Home Must Compensate for Losing Mother's Amputated Legs,” Sun-Sentinel (Fort Lauderdale), May 16, 1997, at 1B.

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