Access to Genetic Resources and the Fair and Equitable Sharing of Benefits arising from their Utilisation Regulations, 2016 (L.N. 379 of 2016).

The aim of these Regulations is to ensure the fair and equitable sharing of the benefits arising from the utilization of genetic resources for which Malta has sovereign rights, as well as the fair and equitable sharing of benefits arising from local traditional knowledge associated with genetic resources. Regulation 2 defines the application scope and clarifies that these provisions do not apply to: (a) human genetic resources; (b) genetic resources used as bulk commodities; (c) genetic resources acquired prior to the entry into force of the United Nations Convention on Biological Diversity; (d) the genetic resources for which access and benefit sharing are governed by specialized international instruments that are consistent with, and do not run counter to, the objectives of the Convention and the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation in the Union; (e) genetic resources that Malta determines do not require prior informed consent; (f) marine resources found in areas beyond national jurisdiction; and (g) derivatives accessed independently of genetic resources.