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
Date: 2012-10-04
Institutions: European Commission
Subjects: access to information, administrative check, catalogue, exploitation of resources, genetics, profit sharing, research results, scientific cooperation

EUROPEAN 
COMMISSION 

Brussels, 4.10.2012  
SWD(2012) 291 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 

{COM(2012) 576 final} 
{SWD(2012) 292 final}

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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. 

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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). 

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– 

– 

– 

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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