CIOPORA Chronicle 2015

Biodiversity
Plant breeding,
whether on the
basis of traditional
or more advanced
techniques, is
essentially the art
of combining the
genetic composition
of existing plant
material into an
improved progeny.
New plant varieties
with higher yields,
altered flower
architecture or
drought resistance
are examples of
how plant breeding
enhances biological
diversity. To achieve
this goal, the lengthy
process of research
and development,
which is inherent
to all plant
breeding activities,
necessarily
presupposes the use
of existing biological
resources.
by Philippe de Jong
Are you being
duly diligent??
There are various types of
genetic resources a breeder
can use to create genetic
variation, including: using his own
breeding material, using material
from gene banks, building on the
material of commercially available
plant varieties, or using material
collected in the wild during bioprospecting
missions.
The international
ABS framework
In 1992, a specific convention,
called the Convention on Biological
Diversity (CBD), was adopted to
avoid misappropriation of such biological
resources. The CBD’s main
objectives were to ensure that the
planet’s genetic resources remained
sufficiently conserved and used in
a sustainable manner, and that the
benefits arising from their utilisation
would be fairly and equitably
shared with the countries providing
those resources.
Following discussions on how the
CBD could be given more power,
in 2004, the CBD’s members (or
parties) were instructed to elaborate
and negotiate an international
regime to advance the achievement
of the CBD’s third objective (concerning
access to genetic resources
and benefit-sharing). That process
eventually led to the adoption of
the Nagoya Protocol to the CBD
on 30 October, 2010.
The Nagoya Protocol sets out a
general framework on “access and
benefit-sharing” (ABS) of genetic
resources. It provides that benefits
arising from the utilisation of
genetic resources should be shared
“in a fair and equitable way with
the party providing such resources
that is the country of origin of such
resources...”.
The specific conditions under
which benefits are shared for spe-
Formal and
substantive duty
The precise format of the formal
obligation still needs to be defined
in the implementing legislation, but
it will, in any event, entail the filing
of a declaration form on two occacific
transactions are to be set out
in Mutually Agreed Terms (MAT),
i.e. private law contracts between
the provider and the user of the
genetic resources.
It also provides that the country
of origin exercises sovereignty over
its genetic resources and thus has
the right to require that its genetic
resources are only accessed with its
Prior Informed Consent (PIC).
The Protocol also establishes a
so-called “ABS Clearing-House”.
Under this mechanism, which
is a feature on the CBD website,
all information on ABS should
be shared, including information
from each party to the Nagoya
Protocol on the applicable rules and
formalities for PIC and MAT. Next
to these rules on ABS, the Nagoya
Protocol also sets out the obligations
for Parties to take appropriate
measures to ensure compliance
with and monitoring of those rules.
The European scene:
under construction
In Europe, the implementation
of the ABS rules has been left to
the Member States. The European
Union, however, has adopted a
specific Regulation to implement
the compliance pillar of the Nagoya
Protocol, - Regulation 511/2014/
EU of 16 April, 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 Utilization in
the Union” (the NPC Regulation).
The NPC Regulation (partially)
entered into force on 12 October,
2014, which also happens to be the
date of the entry into force of the
Nagoya Protocol. The rest, including
its most important provisions
on the formal and substantive due
diligence obligations, which are set
out further below, will enter into
force one year later, on 12 October,
2015.
It would by far exceed the boundaries
of this short article to discuss
the scope of the NPC Regulation
in detail, particularly since quite a
number of elements remain unclear
and await further implementation
and/or clarification by the European
Commission.
In January 2015, the Commission
organised a stakeholder meeting
and it is currently developing
implementing rules and guidance
documents based on the results of
that meeting. All this should be
ready by October 2015.
In a nutshell, however, the NPC
Regulation is said to apply to
“genetic resources over which States
exercise sovereign rights ... that are
accessed after [12 October 2014]”.
EU law-makers have taken the
view that such sovereign rights
are not necessarily exercised just
with respect to the raw material
in the form received, but can also
be exercised in respect of all types
of genetic resources, including commercial
varieties. It will be up to
breeder to determine whether sovereign
rights are exercised regarding
the biological material he wants to
use in his breeding program. If they
are and if the genetic resources were
accessed after 12 October 2014,
then the NPC Regulation imposes
both a substantive obligation to
exercise due diligence and a formal
obligation to declare that such due
diligence has been exercised.
38 www.FloraCulture.eu | CIOPORA Chronicle June 2015