S.L. 549.111 Art. 2Scope.

(1) The aim of these regulations is to ensure the fair and equitable sharing of the benefits arising from the utilisation 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.

(2) These regulations shall 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 specialised 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 (ABNJ); and

(g) derivatives accessed independently of genetic resources.

(3) The provisions of these regulations shall not prejudice specialised international access and benefit-sharing instruments which are consistent with the Nagoya Protocol, such as the Pandemic Influenza Preparedness Framework for the sharing of influenza viruses and access to vaccines and other benefits (the ‘PIP’ Framework) and the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA).

(4) These regulations shall place the national legal regime of the access to genetic resources and the fair and equitable sharing of benefits resulting from their utilisation and lay down provisions required for the implementation of:

(a) Regulation (EU) No. 511/2014 on compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation in the Union and related implementing Regulations;

(b) the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation to the Convention on Biological Diversity; and

(c) Article 15 of the Convention on Biological Diversity; and shall be read and construed as one with such legal instruments.