Source: EURLEX
Language: en
Format: md

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# 52012SC0291

**COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT Accompanying the document Proposal for a Regulation of the European Parliament and of the Council on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union /\* SWD/2012/0291 final \*/**

  

COMMISSION STAFF WORKING DOCUMENT

EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT

Accompanying the document

Proposal for a Regulation of the
European Parliament and of the Council

on Access to Genetic Resources and
the Fair and Equitable Sharing of Benefits Arising from their Utilization in
the Union

Executive summary

This impact assessment (IA) accompanies the Commission
proposal for an EU Regulation on Access to Genetic Resources and the Fair and
Equitable Sharing of Benefits Arising from their Utilization in the European
Union.

The presentation of the proposal responds to
political commitments for an early EU implementation and ratification of the
Nagoya Protocol made by the European Parliament, by the Council of the European
Union, and by the Commission. It is the next step after the Union formally signed
the Nagoya Protocol in June 2011.

For preparing this IA, DG Environment
contracted an external consultant team to undertake a comprehensive study. It also
conducted a public consultation with stakeholders. Commission officials further
held numerous meetings with experts from stakeholders and Member States, and
also consulted with several international partners. The findings of this work
are summarized in this document.

The Convention on Biological Diversity (CBD) obliges
all Parties to facilitate access to genetic resources over which they hold
sovereign rights. It also obliges all Parties to share in a fair and equitable
way the results of research and development and the benefits arising from the
commercial and other utilization of genetic resources with the Party providing
these resources. The CBD also addresses the rights of indigenous and local
communities that hold traditional knowledge associated with genetic resources,
and which may provide important lead information for the scientific discovery
of interesting genetic or biochemical properties.

However, the CBD provides little detail on how
access and benefit-sharing (ABS) for the use of genetic resources and
associated traditional knowledge should be done in practice. Particularly
industrialized country Parties have been reluctant to adopt measures supporting
effective benefit-sharing of their researchers and companies. As one
consequence, some provider countries have established increasingly restrictive
conditions for access to genetic resources or associated traditional knowledge.
At the same time and in the absence of clear rules, European researchers and
companies have been accused of 'biopiracy' by countries claiming a violation of
their sovereign rights. These problems have seriously undermined global
progress to conserve and sustainably use biological diversity; not least since
states that are considered as 'biodiversity-hotspots' stand to gain the most
from an effective ABS framework.

The Nagoya Protocol is a new international
treaty adopted on 29 October 2010 by the 193 Parties to the CBD by consensus.
It is a treaty with legally binding force that significantly expands the
general ABS framework of the CBD. The Nagoya Protocol is expected to enter into
force in 2014. Once operational, it will generate significant benefits for
biodiversity conservation in states that make available the genetic resources
over which they hold sovereign rights. It will in particular:

–
Establish more predictable conditions for access
to genetic resources.

–
Ensure benefit-sharing between users and
providers of genetic resources.

–
Ensure that only legally acquired genetic
resources are used.

The Nagoya Protocol will need to be ratified
by the Union and all of its Member States. The Union
and each of its Member States must be able to demonstrate compliance with all
Protocol obligations. How this is achieved is an entirely internal matter to
the EU and its Member States. The concrete approach chosen rests on legal and
practical considerations: any EU-level intervention presupposes the existence
of Union competence and the demonstration of added value that will not be
achieved through implementing measures under the sole responsibility of Member
States.

A broad set of options was considered in the
course of the IA. All options were analyzed against a "business as usual"-baseline
without implementing measures at EU or Member State level.

Options on access analyzed were "no
EU-level action" (A-1) and the "establishment of an EU platform for
discussing access and sharing best practices" (A-2).

Options on user-compliance analyzed were "Open
method of coordination" (UC-1), "Self-standing general due diligence
obligation on EU users" (UC-2), "General due
diligence obligation on EU users complemented with a system to identify
collections as 'trusted sources' of genetic resources" (UC-3),
"Prohibition to utilise illegally acquired genetic resources or associated
traditional knowledge with a 'downstream' monitoring
system (UC-4).

The IA also analyzed two options for the
temporal application of EU-level measures. These were the possibility of
applying EU-level measures only to genetic resources or associated traditional
knowledge acquired in the future (T-1) and the application of such measures as
of the entry into force of the CBD in 1993 (T-2).

Complementary measures analyzed related to: Bilateral
agreements between EU and major provider countries or regions (C-1); Sectoral
codes of conduct and contractual model clauses (C-2); Technical tools for
tracking and monitoring (C-3); and Awareness raising and training activities
(C-4).

The specific criteria for analysing and comparing
the options addressed issues specific to the Nagoya Protocol as well as
economic, social and environmental impacts.

The best performing set of EU-level
implementing measures identified in this IA are:

–
the establishment of an EU platform where Member
States, the Commission, and stakeholders will discuss access to genetic
resources and the sharing of best practices (A-2).

–
an obligation on EU users to take steps to the best
of their ability to ensure that genetic resources and associated traditional
knowledge utilized were acquired in line with access laws of provider countries
and that resulting benefits are shared (UC-3).

–
a system for identifying collections (botanical
gardens, microorganism collections, gene banks etc) with control measures to
assure that only well documented samples of genetic resources are made
available for utilization (UC-3).

–
complementary measures to enhance the effectiveness
of the EU-level intervention (C-1, C-2, C-3, C-4).

The EU Regulation would only apply to genetic
resources and traditional knowledge that were acquired and utilized after the
entry into force of the Nagoya Protocol for the Union (T-1).

The EU platform for
discussing access and sharing best practices has some
potential to streamline access conditions applied by Member States that require
prior informed consent. This would not result in an EU-level playing field on
access. Nevertheless any narrowing of differences between Member State access
frameworks would lower transaction costs and be particularly beneficial for
SMEs and recipients of public funds. The EU platform would also showcase best
practices on access. This would help Member States to learn from each other. It
would also help users to identify the Member State with the best functioning
access frameworks. Both aspects would positively contribute to research and
development opportunities in the EU.

The due diligence obligation on EU users
complemented by a system to identify collections as "trusted sources"
would provide an EU-harmonised approach to implementing the
user-compliance pillar of the Protocol. It would establish a level playing
field for all actors in the EU genetic resources value chain, provide legal
certainty, minimise their risks of operation and maximise research and
development opportunities. It would also prevent differences in user-compliance
obligations between different Member States that would result in costs and
barriers for researchers and companies active in more than one Member State.
Notably, stakeholders unanimously supported an EU harmonised approach to
user-compliance in the consultation.

The system of EU measures for implementing
the Nagoya Protocol could be based on the Union's environment competence. The
creation of an EU-wide system of user-compliance measures could also be based
on the Union's competence for the internal market. An EU-level intervention on
user-compliance is also justified as it avoids negative effects on the internal
market in nature-based products and services that would result from a
fragmentation of user-compliance systems in the Member States and also has the
best performance as regards the creation of an enabling context for research
and development on genetic resources with benefits for the conservation and
sustainable use of biological diversity worldwide.

The totality of measures taken at EU-level
would allow Union ratification and achieve full EU compliance with Nagoya
Protocol. Member States would have discretion whether or not to require prior
informed consent and benefit-sharing for genetic resources that belong to them.
Their decisions on this would not be a precondition for Union ratification.

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