"Is there a Demand for the Worldwide Regulation of Gene Therapy?"

Abstract

In recent years, the legal and ethical issues surrounding gene therapy have been the subject of considerable debate and subsequent attempts at legislation worldwide. Accordingly, there have been several efforts on the part of national governments and various medical and public interest groups to regulate and monitor recombinant DNA research due to concern over the alleged physical risks to the community. However, the growing international use of gene therapy also raises the issue of whether regulations should be national and/or international, and whether different standards can be justified in different countries. The arguments in favor of international regulation emphasize evolutionary considerations, the transitory nature of nations, and the basic principles of international law. However, it has also been argued that transnational agreements in advance of technology are unreasonable and that regulatory authorities should use the successes and failures of national attempts at regulation before adopting international guidelines or declarations. Based upon a review of the current state of affairs, the majority of the national legal instruments in countries which conduct research or actually practice somatic gene therapy appear to be sufficient for the current state of the science. However, the rapid advances being made in the field of recombinant DNA technology suggest that the legal regulation of gene therapy will be needed in the near future to present internationally accepted standards of practice.