Three Legal Frameworks for Regulating Genetic Technology
Wilson Ray Huhn
University of Akron - School of Law
November 5, 2010
JOURNAL OF CONTEMPORARY HEALTH LAW AND POLICY, Vol, 19, pp. 1-36, 2003
The law uses three frameworks to regulate genetic technology: (1) Individual Rights and Duties; (2) Scientific Regulation by Administrative Agencies; and (3) Legislative Preemption. Each framework is invoked by a different decisionmaker, and each imposes a different level of scrutiny over genetic technology.
Actions to enforce Individual Rights and Duties are initiated by individuals. This framework involves the lowest level of government oversight over genetic technology. The core of this approach is to establish legal rights for individual citizens under the traditional sources of law: the common law, specific remedial statutes, and the Constitution. Under this framework people are free to act unless and until they harm others. The law makes no attempt to prevent harm other than to deter it by acknowledging the right of an affected person to sue for damages.
Scientific Regulation is conducted by administrative agencies, and results in a higher level of scrutiny over genetic technology. This is currently the most common form of regulating the biotechnology industry in the United States. However, our national experience has not resulted in a very strict level of administrative oversight. Administrative regulations take years to develop, the agencies bear the burden of justifying the regulations in court, and agency policy is subject to reversal by each new Presidential administration. Adding to the difficulty is that administrative agencies in the United States have had to act under existing laws that have not been amended to deal with the novel challenges of genetic technology.
The highest level of oversight, Legislative Preemption, is essentially hostile to genetic technology, and would severely restrict the application of this new science. The fundamental precept of this framework is "safety first" - the precautionary principle. Under this regulatory framework the government - usually the legislative branch - forbids or severely limits the development and application of new technology until it is proven safe. But because we do not yet know all of the consequences of genetic technology - because it cannot be proven safe in advance - this type of precautionary legislation often operates as a virtual ban.
Each legal framework plays a critical role in regulating genetic technology. Individual rights must be protected, industries must be regulated, and exploitative or dangerous practices banned. Furthermore, observers have identified a number of reforms that should be adopted within each framework. The law must enhance individual autonomy by more clearly recognizing rights to genetic privacy and nondiscrimination. A more comprehensive regulatory framework should be adopted, with stricter controls over the applications of genetic technology, and stronger protections for human safety. Finally, legislative bans should be considered against exploitative and dangerous experiments.
Number of Pages in PDF File: 34
Keywords: law and genetics, bioethicsAccepted Paper Series
Date posted: November 12, 2003 ; Last revised: November 19, 2012
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