Biotechnology, the application of engineering concepts to biological processes, is relatively new, rapidly growing, and profoundly important. The field is sprawling and complex. California, especially northern California, has been a world leader in biotechnology and bioindustry since modern biotechnology was "invented" in the San Francisco Bay Area in 1973. One of the key scientific breakthroughs that made the field possible, gene splicing, depends on technology developed by professors at the University of California at San Francisco and Stanford University. The California State Assembly has been involved in bioindustry public policy making for over 10 years. This research issue paper was requested by Assemblymember John Vasconcellos to inform policy makers about the industry and critical issues relevant to its future growth and development.
The U.S. Congress Office of Technology Assessment summed up biotechnology and its potential nearly a decade ago:
The United States stands at the brink of a new scientific revolution that could change the lives and futures of its citizens as dramatically as did the Industrial Revolution two centuries ago and the computer revolution today. This new revolution is based on advances in molecular biology that permit the identification, alteration, and transfer of genetic materials that control fundamental characteristics of organisms. The ability to manipulate genetic material to achieve specified outcomes in living organisms (and in some cases their offspring) promises major changes in many aspects of modern life. 1
The public knows relatively little about the complex science behind biotechnology. Surveys suggest general support for the field's achievements along with concerns about potential ethical, social, and economic impacts. Questions include who is paying for the research, how is the industry being regulated, who benefits, and what are the expected impacts. Support varies depending on the particular discovery or product.
The report that follows focuses on the issues that are most crucial to California's bioindustry. 2 Industry public policy issues generally fit into three categories:
We are watching a technological revolution unfold. We do not know how the tension between bioethical issues and research projects will be resolved, nor how bioindustry and its marketplace will ultimately organize themselves to produce, market, and sell these products. These development raise an awesome range of issues of social and economic significance. Sheldon Krimsky, a nationally known expert, suggests just how extensive this latitude is in terms of public policy:
What is the responsibility of government in regulating biotechnology? How much effort should be put into evaluating the hypothetical risks of biotechnology? Should universities enter into partnerships with industry to earn profits from faculty research? Should we use genetic engineering on humans? Should animals be patentable subject matter? Is there a public role for directing biotechnology toward specific ends or should the market decide which products get developed? Will government and private industry cost-containment efforts have a negative effect on the health and medical device components of the industry? 3
Many of these questions have been or are being answered today and are relevant to California bioindustry's development.
The paper sketches how several factors interact to shape the industry's development. These factors include:
The pattern that emerges is used to identify government policy options.
Next Chapter: An Overview of Biotechnology and Bioindustry
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