"A Comparison of Biotechnology Regulatory Policy in the United States and the European Union"

Patterson, Lee Ann. (1999) "A Comparison of Biotechnology Regulatory Policy in the United States and the European Union". In: UNSPECIFIED, Pittsburgh, PA. (Unpublished)

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Abstract

Polities are increasingly faced with competition in the regulatory arena as well as the market place. Several authors have argued that regulatory competition leads to regulatory harmonization or convergence. However, significant differences in biotechnology regulations in the United States and the European Union remain. These differences have resulted in profoundly different technology trajectories. This paper compares the historical development of guidelines and regulations in the US and the EU. Specific attention is paid to 1) differing philosophies of regulation, 2) the affect of varying societal views of the technology on the regulatory structure, 3) the degree of inter-agency or inter-Directorate-General coordination in the policy making process, and 4) the ability of both regulatory systems to adapt to new scientific information. Finally, the impact of these different regulatory structures on the technology trajectory of bio-industries in the US and the EU is examined.

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