Innovation in the use of biological material has surged ahead over the past decades, closely followed by additions and amendments to the regulatory environment.

The aim of this chapter is to explore the most important legal tools relating to the use of genetic resources and to identify the significant changes and additions.

The article looks at the critical aspects for a successful implementation of the Nagoya Protocol. Three topics are especially covered: the need for (a) developing sound access and benefit sharing (ABS) contracts; (b) establishing provider and user legislation or regulation in all countries; and (c) avoiding fragmentation at the international legal level concerning ABS.

The regulatory environment is increasingly focused on strengthening intellectual property rights (patents and plant breeders’ rights) and access to and sharing of benefits arising from the use of genetic resources in terms of ABS. Whereas the regulation of use depends on the laws enacted in each country where bioprospecting occurs, the international arena has become increasingly important for law-making in the last 30 years.