The regulatory system in the EU and further afield

Abstract

The regulation of modern biotechnology began almost as soon as the potential benefits and risks became clear. In some countries a decision was made to use current law to address the new technologies, arguing that the changes that are able to be introduced into new products are not substantially different from those introduced by other techniques. In other jurisdictions new law was enacted to ensure that the products are at least as safe (or as some would have it, safer) than those currently on the market.

New treaties that have attracted widespread support among 'consumer' countries and indifference or hostility among 'producer' countries have just come into force, requiring countries to address the regulation of biotechnology and assess the risks to biological diversity and to human health of introducing living modified organisms into their territory.

Public perception of genetic engineering has led to changes in the regulatory system, which may not be justified by the risks posed by this technology. In particular, the national and international requirements that have been currently agreed require an analysis of risk only rather than a balancing of risk with the benefits that may accrue.