Public policy, biotechnology

National Academy of Sciences-National Academy of Engineering-Institute of Medicine, Committee on Science, Engineering, and Public Policy. "Report of the Research Briefing Panel on Chemical and Process Engineering for Biotechnology," in Research Briefings 1984. Washington, D.C. National Academy Press, 1984. 

This chapter is based on a presentation to the Dallas Federal Reserve Bank in April 2002. A similar version of the paper was published by Georgetown Public Policy Review and by the Dallas Fed in Science and Cents The Economics of Biotechnology. 

The Georgetown Public Policy Review, 8, 7-24, 2003 Science Cents Exploring the Economics of Biotechnology, in Proceedings of a Conference, 2002, Sponsored by the Federal Reserve Bank of Dallas, Ducca, J.V. and Yucel, M.K., Eds., Federal Reserve Bank of Dallas, 2003, pp. 87-104. 

Since risk analysis plays an important role in public policy decision making, efforts have been made to devise a means by which to identify, control, and communicate the risks imposed by agricultural biotechnology. A paradigm of environmental risk assessment was first introduced in the United States by Peterson and Arntzen in 2004. In this risk assessment, a number of assumptions and uncertainties were considered and presented. These include (1) problem formulation, (2) hazard identihcation, (3) dose-response relationships, (4) exposure assessment, and (5) risk characterization. Risk assessment of plant-made pharmaceuticals must be reviewed on a case-by-case basis because the plants used to produce proteins each have different risks associated with them. Many plant-derived biopharmaceuticals will challenge our ability to define an environmental hazard (Howard and Donnelly, 2004). For example, the expression of a bovine-specihc antigen produced in a potato plant and used orally in veterinary medicine would have a dramatically different set of criteria for assessment of risk than, as another example, the expression of a neutralizing nonspecihc oral antibody developed in maize to suppress Campylobacter jejuni in chickens (Peterson and Arntzen, 2004 Kirk et al., 2005). 

URL http //www.phrma.org E-mail web form Phone (202) 835-3400 950 F Street NW Washington, DC 20004 Represents leading pharmaceutical and biotechnology companies in the United States and advocates for public policies that support the efforts of companies to discover and market new medicines. 

Robert A. Freeman is a 20-year veteran of the global pharmaceutical industry, having led public policy and health economics groups for a number of companies. He is currently Principal of the Freeman Group LLC, a consultancy to the pharmaceutical, biotechnology, and medical device industries. He has widely published in the fields of pharmaceutical policy, industry economics, and technology assessment, and holds adjunct faculty appointments at the Thomas Jefferson University Department of Health Policy and The University of Maryland Center on Drugs and Public Policy. 

Carol N. Scott. Executive Director of the Committee to Coordinate Environmental Health and Related Programs, U.S. Department of Health and Human Services, speaking from the perspective of the public policy analyst, noted that in an ideal political and social climate a risk assessment should, in advance of a crisis, present to knowledgeable risk managers a quantitative risk assessment which expresses all of the uncertainties incorporated in the assumptions. However, too often the crisis occurs first, and the public-press-politician synergistic relationship takes over, as in the case of the ethylene dibromide situation, or someone leaks misinformation to the press, as in the case of Alar, or politics takes over, as in the case of the controversy over the appropriate ways to use and regulate biotechnology. 

Biotechnology Patents, Public Policy, Public Opinion, and Morality 1396... 

BIOTECHNOLOGY PATENTS, PUBLIC POLICY, PUBLIC OPINION, AND MORALITY... 

Public Policies for Avoiding Mistakes in Biotechnology Developments... 

J. HE PUBLIC POLICY DEBATE on biotechnology development has shifted its focus from laboratory to deliberate-release issues. Thus, the feasibility and pace of agricultural applications is significantly influenced by newly formulated regulatory schemes, court proceedings, legislative deliberations, and evolving public perceptions. 

Probably of paramount importance, however, will be industry s attempt to secure at the outset a commitment for periodic review of the early regulations and a modification of restraints proven unduly conservative for public and environmental protection needs. This approach attempts to borrow from recent history, when the biotechnology public policy debate... 

Modern fields such as bioengineering and biotechnology have evolved out of the solid foundations of physics, chemistry, and, more importantly, biology. Despite the trailblazing advancements, society still experiences an imbalance in the scientific and technological literacy of citizens. This has serious implications for public policy formulation, especially for developing countries. 

Chataway, ]., Tait, J. Wield, D. (2006) The governance of agro- and pharmaceutical biotechnology innovation public policy and industrial strategy. Technology Analysis and Strategic Management, 18 (2), 169-85. 

If public opinion shapes EU policy, then a certain amount of uncertainty surrounds the future of agri-food biotechnology. The lack of equilibrium between the EU and the US adds to the global uncertainty over the issue since both are powerful political and trade powers and have yet to find common ground. This section will interpret the consequences of this uncertainty as the national and industrial responses to changes in their economic interests. 

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