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
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.