NagoYa Protocol

The Nagoya Protocol, based on Articles 3 and 15 of the Convention on Biological Diversity (CBD) signed in Rio de Janeiro on 5 June 1992, regulates access to genetic resources, such as bacteria, viruses and cell cultures. It ensures a fair and equitable access and sharing of the benefits arising from their use (ABS) in order to fight the phenomenon of biopiracy against developing countries at the international level.

In line with the aims of the Convention, the Protocol defines that procedures for access to and use of genetic resources and/or associated traditional knowledge must respect the principles of certainty, clarity and transparency, based on non-arbitrary legal rules, in accordance with national laws and regulations.

On the basis of these principles, the compliance mechanism, governed by the Protocol in Articles 15 and 16, is developed, allowing to user to obtain a permit, or equivalent document, from the supplier State for access to and use of genetic resources and/or associated traditional knowledge.

Access is subject to the Prior Informed Consent (PIC) of the supplying State and/or local indigenous communities, in accordance with national legislation.

The fair and equitable sharing of the benefits arising from the use of the resources and/or associated traditional knowledge is mutually agreed between the supplier and the user in private agreements (MAT).

In order to prevent and sanction cases of illegal appropriation of genetic resources, Article 15 of the Protocol obliges States to provide sanctions and remedies to be applied in cases of non-compliance behavior of user, thus defining the due diligence mechanism provided for by Regulation (EU) No. 511/2014.

The Regulation defines that the use, in the Union, of genetic resources acquired before 12 October 2014, acquired from areas beyond the national jurisdiction of a State (high seas) or covered by the Antarctic Treaty system, is not subject to the Regulation. On the contrary, only those genetic resources coming from States that have ratified the Nagoya Protocol and that have prepared regulations on ABS fall within the scope of the Regulation.