Communication from the Commission to the European Parliament and the Council - The implementation by the EC of the "Bonn Guidelines" on access to genetic resources and benefit-sharing under the Convention on Biological Diversity
Date: 2003-12-23
Institutions: European Commission
Subjects: European convention, biodiversity, biotechnology, conservation of resources, exploitation of resources, natural resources

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 23.12.2003
COM(2003) 821 final

COMMUNICATION FROM THE COMMISSION
TO THE EUROPEAN PARLIAMENT AND THE COUNCIL

The implementation by the EC of the “Bonn Guidelines” on access to genetic resources
and benefit-sharing under the Convention on Biological Diversity

{SEC(2003) 1455}

EN

  EN

ABS

BCCM

BCH

CBD

CGIAR

CSR

COP

EC

List of abbreviations

Access and Benefit-Sharing

Belgian Co-ordinated Collections of Micro-organisms

Biodiversity Clearing House

Convention on Biological Diversity

Consultative Group on International Agricultural Research

Corporate Social Responsibility

Conference of the Parties

European Community

EC-CHM

European Community Biodiversity Clearing House Mechanism

ECCO

EMAS

EU

FAO

IGC

IT-PGRFA

MAT

MTA

MIRCEN

MOSAICC

MS

NBSAPs

NGO

PCT

PIC

European Culture Collections Organisation

Eco-Management and Audit Scheme

European Union

Food and Agriculture Organisation

Inter-Governmental Committee

International  Treaty  on  Plant  Genetic  Resources  for  Food  and
Agriculture

Mutually Agreed Terms

Material Transfer Agreement

Microbial Resource Centre Network

Micro-organisms  Sustainable  Use  and  Access  Regulation
International Code of Conduct

Member State/s

National Biodiversity Strategy and Action Plans

Non-governmental Organisation

Patent Co-operation Treaty

Prior Informed Consent

2

 
PLT

R&D

TRIPs

TK

UNESCO

UPOV

WFCC

WIPO

WSSD

WTO

Patent Law Treaty

Research and Development

Trade Related Aspects of Intellectual Property Rights

Traditional Knowledge

United Nations Educational Scientific and Cultural Organisation

The  International  Union  for  the  Protection  of  New  Varieties  of
Plants

World Federation for Culture Collections

World Intellectual Property Organisation

World Summit on Sustainable Development

World Trade Organisation

3

 
Executive summary

This Communication concerns the implementation by the European Community (EC) of the
Bonn Guidelines on access to genetic resources and benefit-sharing which were adopted at the
6th Conference of the Parties of the Convention on Biological Diversity (CBD), in April 2002.

Genetic  resources  are  of  increasing  importance  for  a  growing  number  of  economic  sectors.
Users  of  genetic  resources  are  mostly  located  in  the  developed  world  while  providers  are
often in developing countries.

Sharing fairly and equitably, between users and providers, the benefits arising from the use of
genetic  resources  is  one  of  the  objectives  of  the  CBD  and  the  Bonn  Guidelines  are  an
important tool to achieve it.

The  EC  is  committed  to  the  implementation  of  the  CBD  provisions  on  access  and  benefit-
sharing  (ABS)  and  was  an  active  negotiator  of  the  Bonn  Guidelines.  The  latter  have  the
potential  to  contribute  to  the  objective  of  sustainable  development  as  they  provide  for  the
benefits arising from the utilization of genetic resources to be used to improve conservation
and sustainable use of biodiversity.

The  Communication  addresses  the  wider  international  context  of  the  debate  on  access  and
benefit-sharing  which  includes  the  recently  adopted  Food  and  Agriculture  Organisation
(FAO) International Treaty on Plant Genetic Resources for Food and Agriculture, the work of
the World Intellectual Property Organisation and the World Trade Organisation, the outcome
of  the  World  Summit  on  Sustainable  Development  and  the  Conventions  under  the
International Union for the Protection of New Varieties of Plants.

An  overview  is  provided  of  EC  policy  approach  to  and  measures  on  ABS,  including  in  the
framework  of  the  EC  Biodiversity  Strategy,  in  relation  to  the  EC  Directive  on  the  legal
protection  of  biotechnological  inventions  and  the  Regulation  on  community  plant  variety
rights.  EC  stakeholders’  action  is  also  presented  in  particular  with  regard  to  institutional
policies, codes of conduct and corporate policies.

After  a  brief  description  of  the  main  features  of  the  Bonn  Guidelines,  the  paper  introduces
possible ways for the EC to implement them. The EC role as provider of genetic resources is
presented  as  well  as  possible  actions  for  the  EC  to  foster  users’  measures  which  are  in
harmony  with  the  Guidelines.  Material  transfer  agreements  and  stakeholders’  codes  of
conduct are singled out as key instruments for stakeholders to live up to their responsibilities
as identified by the Bonn Guidelines.

The  Communication  presents  measures  which  the  Commission  believes  could  raise  users’
awareness of their obligations under the CBD, including: the creation of a European network
of ABS focal points; the establishment of a specific section on ABS on the EC Biodiversity
Clearing  House Mechanism, and the setting  up of a  register  of  stakeholders’  groups  on  this
clearing house. Moreover, the integration of the ABS issue into the EC process on Corporate
Social Responsibility is also envisaged.

The Communication recalls existing requirements that can entail the disclosure of the origin
of  genetic  resources  and  related  traditional  knowledge  under  EC  law  and  European
intellectual property law and recognises  the  possible  role  of  such  requirements  in  providing
incentives for the respect of prior informed consent by the providers of genetic resources.

4

 
The  Communication  refers  to  the  possible  introduction  of  a  self-standing  disclosure
requirement  for  patent  applicants  in  the  EC  legal  order.  Such  a  requirement  would  be
characterised as a ‘self-standing obligation’ whose non-respect will  only  have consequences
outside  the  field  of  patent  law.  The  Commission  will  also  look  into  the  feasibility  of
introducing  a  similar  disclosure  requirement  in  the  context  of  plant  variety  rights.  The
Commission believes that the EC and its MS should also be ready to discuss, in the relevant
international fora, the possibility of making this disclosure requirement a formal condition of
patentability. In that case, the consequences of the non-respect of the requirement would fall
both within and outside the field of patent law.

The Commission also considers that the EC and its MS should be open to further discuss the
development,  in  the  CBD  framework,  of  a  certificate  of  origin  for  genetic  resources  as
evidence  of  prior  informed  consent,  provided  that  this  is  not  framed  in  a  way  which  would
prevent  stakeholders  from  enjoying  the  flexibility  needed  in  order  to  carry  out  their
transactions.

The Communication highlights the possible role of arbitration and of ABS focal points to ease
the addressing of infringements of ABS arrangements  and the potential  role of the EC Eco-
Management  and  Audit  Scheme  as  a  voluntary  certification  scheme  for  organisations  that
comply with the Bonn Guidelines.

In relation to the possibility of fostering the implementation of the Bonn Guidelines in third
countries,  the  Communication  underlines  the  importance  of  the  implementation  of  the
relevant  aspect  of  the  EC  Biodiversity  Action  Plan  for  Economic  and  Development  Co-
operation and of the EC Communication on Life Science and Biotechnology.

Finally,  the  role  of  the  EC  in  international  fora  in  order  to  further  develop  a  transparent
international regime on access and benefit-sharing is outlined.

5

 
1. 

INTRODUCTION

The issue: what does it mean?

The fair and equitable sharing of the benefits arising out of the utilisation of genetic resources,
including by appropriate access to them, is one of the three objectives of the Convention on
Biological Diversity (CBD).

Genetic  resources  are  usually  classified  under  three  broad  categories:  plant,  animal  and
microbiological  genetic  resources.  They  are  of  fundamental  importance  for  many  areas  of
scientific  research,  in  the  field  of  agriculture  (e.g.  in  plant  breeding),  and  for  an  increasing
number  of  industry  sectors,  including  biotechnology,  pharmaceutical,  botanical  medicine,
horticulture  and  cosmetics.  These  industry  sectors  already  make  use  of  a  wide  range  of
genetic  resources  and  some  of  them  make  considerable  investments  in  bio-prospecting
activities in order to discover possible new applications of genetic resources. These activities
often take place in countries which hold the richest biodiversity on the planet (so called mega
bio-diverse countries, mostly in Latin America, south-east Asia, Oceania and, to some extent,
Africa).

The  above  mentioned  CBD  objective  reflects  the  need  felt  by  the  negotiators  of  the
Convention to ensure that companies and research institutes, located mostly in industrialised
countries, are obliged to share the gains derived from the use of genetic resources.

Therefore, the issue of Access and  Benefit Sharing (ABS)  is seen  as an issue  of  equity  and
fairness. In this respect, all Contracting Parties have accepted, in Article 15.7 of the CBD, to
take  measures  aimed  at  sharing  in  a  fair  and  equitable  way  the  results  of  research  and
development  and  the  benefits  arising  from  the  commercial  and  other  utilisation  of  genetic
resources  with  the  Contracting  Party  providing  such  resources.  Article  15.2  of  the  CBD
encourages  Parties  to  “create  conditions  to  facilitate  access  to  genetic  resources  for
environmentally sound uses”. This is important because without access there will be little or
no benefits to share.

Europe  is  historically  an  important  user  of  genetic  resources  in  both  research  and  product
development.  Europe  is  also  a  provider  of  such  resources  home  to  a  rich  biodiversity,
including the Mediterranean hotspot, and to a large  number of  ex situ collections,  including
agricultural  collections,  microbial  culture  collections,  zoos  and  botanic  gardens.  These
collections have a high potential for conservation, as they often contain rare and endangered
species and carry out propagation projects.

The level of demand for genetic resources within the EU across different industrial sectors is
hard to estimate and shifts with time, e.g. in line with technological innovations. Nevertheless,
the  EU  possesses  substantial  commercial  R&D  capacity  and  European  entrepreneurial  life
sciences industry constitute an important sector of the European economy.

What has the CBD done for the implementation of its objective on ABS?

The CBD objective on ABS is enshrined in its Article 1. This provision only sets out general
principles. A framework for the implementation of this objective is provided in Article 15 of
the Convention which recognises the sovereign right of States over their natural resources and
contains  reference  to  the  notions  of  Prior  Informed  Consent  (PIC)  and  Mutually  Agreed
Terms  (MAT)  to  obtain  access  to  genetic  resources.  In  addition,  Article  8(j)  contains

6

 
provisions  to  encourage  the  equitable  sharing  of  the  benefits  arising  from  the  utilisation  of
knowledge,  innovations  and  practices  of  indigenous  and  local  communities  embodying
traditional lifestyles relevant for conservation and sustainable use of biological diversity, and
Article 10(c) requires Parties to protect and encourage customary use of biological resources.
Furthermore,  Articles  16  to  19  put  great  emphasis  on  access  to  and  transfer  of  technology,
including  biotechnology,  on  exchange  of  information  and  on  technical  and  scientific  co-
operation as tools for the achievement of the objectives of the Convention.

Responding  positively  to  developing  countries'  requests,  the  EU  supported,  in  the  fourth
Conference  of  the  Parties  to  the  CBD  (Bratislava,  1998)  the  launching  of  a  negotiation
process  on  the  question  of  ABS  to  explore  all  options  for  access  to  genetic  resources  and
benefit-sharing  on  mutually  agreed  terms.  This  process  led  to  the  adoption,  in  the  Sixth
Conference of the Parties (The Hague, 2002) of the “Bonn Guidelines” on access and benefit-
sharing,1 a set of detailed, voluntary provisions to help implementing Articles 1, 10(c) 15, 16
and 19 and, to some extent, 8 (j).

Why should the EC implement the Bonn Guidelines?

The European Community (EC) and its Member States (MS) are all Parties to the CBD and
are under a legally binding commitment to implement articles 1 and 15 of the CBD, including
Article  15.7.  The  Bonn  Guidelines  are  a  voluntary  instrument.  However,  the  Plan  of
Implementation of the World Summit on Sustainable Development (paragraph 44(n) calls for
the  promotion  of  their  wide  implementation  as  an  input  to  assist  Parties  to  the  CBD  when
developing and drafting legislative, administrative and policy measures on access and benefit-
sharing  as  well  as  contracts  and  other  arrangements.  Moreover,  the  Commission  and  the
Member  States  have  been  very  active  in  the  negotiations  leading  to  the  adoption  of  the
Guidelines and are at the origin of most of their provisions. Furthermore, as mentioned above,
this is also an issue of equity: the EC should take action because it is fair to do so.

Ultimately,  if  the  EC  implements  the  Guidelines,  it  will  enhance  their  credibility  and  the
willingness of other countries, international institutions, companies and research institutes all
over the world (and not only in the EC) to implement them. This, in turn, will facilitate the
achievement  of  the  objective  of  sustainable  development  as  the  Guidelines  clarify  that  the
benefits arising from the use of genetic resources should be used to improve conservation and
sustainable use of biodiversity. The issue of ABS is potentially a win-win situation for trade
and environment since benefits arising from the commercial use of genetic resources can be
used to foster  the protection of  biodiversity  and since the  expectation of such benefits  is  an
incentive for conservation.

This  Communication  will  briefly  present  the  international  context  on  ABS  after  the  World
Summit  on  Sustainable  Development  (WSSD)  held  in  August  2002  as  well  as  existing
measures on ABS at EC level. On this basis, concrete actions for the implementation of the
Bonn  Guidelines  in  the  EC  will  be  proposed  and  the  approach  for  EC  action  at  the
international level will be suggested. The actions proposed here do not aim at an exhaustive
implementation of all aspects of the Guidelines as the latter are to be used as  a flexible tool
which can be adapted to the needs of the different CBD Parties and stakeholders when they
develop ABS-related measures and arrangements. The EC activities on the implementation of
the  Bonn  Guidelines  are  to  be  seen  as  complementary  to  actions  envisaged  by  the  Member
States that should obviously be in accordance with EC and international law.

1

See Annex for the full text of the Guidelines in English [SEC(2003) aaaa]

7

 
                                                
2. 

THE WIDER INTERNATIONAL CONTEXT

Are other international fora relevant to this issue?

The area of ABS is complex and in evolution  as it ranges  from  science to  environment  and
agriculture, from trade to intellectual property instruments. Some specific aspects of the issue
of access and benefit-sharing are under discussion in international fora other than the CBD.

In 2001, the FAO concluded the negotiations of the International Treaty on Plant Genetic
Resources  for  Food  and  Agriculture  (IT-PGRFA).  The  latter  is  the  outcome  of  a  long
process  aimed  at  bringing  a  voluntary  instrument  pre-dating  the  CBD,  the  International
Undertaking  on  Plant  Genetic  Resources  for  Food  and  Agriculture,  “in  harmony”  with  the
CBD  by  creating  a  new  binding  instrument.  This  new  Treaty  provides  for  a  multilateral
system  for  facilitated  access  to  genetic  resources  for  food  and  agriculture  and  for  a
mechanism to share the benefits arising from the use of the genetic resources which are part
of the system. This agreement addresses genetic resources for food and agriculture. The above
multilateral system is limited to crops listed in Annex I of the Treaty.

The  CBD,  including  the  voluntary  Bonn  Guidelines,  continues  to  apply  to  all  biological
resources,  including  those  for  food  and  agriculture  which  are  not  listed  in  the  International
Treaty. The International Treaty and the CBD are complementary and it is expected that their
respective Parties will implement them in a mutually supportive way. The EC and its Member
States signed the IT-PGRFA and are preparing its ratification. The Treaty will enter into force
90 days after the deposit of the 40th instrument of ratification.

In  the  World  Intellectual  Property  Organisation  (WIPO),  the  Inter-governmental
Committee  (IGC)  on  Intellectual  Property,  Genetic  Resources,  Traditional  Knowledge  and
Folklore discusses, inter alia, intellectual property issues that arise in the context of (i) access
to genetic resources and benefit-sharing; and (ii) the protection of traditional knowledge (TK),
whether  or  not  associated  with  those  resources.  It  is  expected  that  this  Committee  will,  in
particular, identify means and ways to protect TK by resorting to intellectual property or other
sui generis rights.

In  the  framework  of  the  World  Trade  Organisation  (WTO),  the  Doha  Ministerial
Declaration,  adopted  in  2001,  instructed  the  Trade-related  Intellectual  Property  Rights
(TRIPs) Council, in pursuing its work program, including under the review of Article 27.3(b),
to  examine  the  relationship  between  the  TRIPS  Agreement  and  the  Convention  on
Biological Diversity, the protection of traditional knowledge and folklore. The debate has so
far  focused  on  the  issue  of  disclosing  the  origin  of  genetic  resources  used  as  the  basis  for
inventions when applying for patents on these inventions.2

The WSSD called on States, in paragraph 44(o) of the Plan of Implementation, to “negotiate
within the framework of the Convention  on Biological  Diversity,  bearing in mind  the  Bonn
Guidelines, an international regime to promote and safeguard the fair and equitable sharing of
benefits  arising  out  of  the  utilisation  of  genetic  resources.”  The  General  Assembly  of  the
United Nations invited the COP of the CBD, in paragraph 8 of Resolution A/Res/57/269, “to

2

In  October  2002,  the  EC  submitted  a  “Concept  paper”  to  the  TRIPs  Council  on,  inter  alia,  the
relationship  between  the  TRIPs  Agreement  and  the  CBD.  See  'Communication  by  the  EC  and  its
Member States to the TRIPs Council on the review of Article 27.3 (b) of the TRIPs Agreement, and the
relationship  between  the  TRIPs  Agreement  and  the  Convention  on  Biological  Diversity  and  the
protection of traditional knowledge and folklore'.

8

 
                                                
take appropriate steps in this regard.” Following the deliberations of the CBD inter-sessional
meeting  on  the  Multi-year  Programme  of  Work  (March  2002),  it  is  now  foreseen  that  the
second meeting of the Ad hoc Open-ended Working Group of the CBD, in December 2003,
will address the issue of "an international regime on access to genetic resources and benefit-
sharing". This issue will also be debated at the seventh meeting of the CBD Conference of the
Parties (COP7), in February 2004, in Malaysia.

Two  Conventions  under  the  International  Union  for  the  Protection  of  New  Varieties  of
Plants (UPOV) - the 1978 and 1991 UPOV Conventions - provide for the protection of new
varieties of plants by an intellectual property right. They are therefore relevant in the context
of the discussion on access to genetic resources and sharing the benefits deriving from their
use.

Finally, it is also worth recalling the special role of the Consultative Group on International
Agricultural  Research  (CGIAR)  in  relation  to  genetic  resources  for  food  and  agriculture.
The  CGIAR  is  an  informal  association  of  public  and  private  donors  that  supports  an
international network of 16 international agricultural research centres. The network holds the
world’s largest ex  situ collection  of plant  genetic  resources  for  food  and agriculture and the
EU is its main sponsor. These resources are placed in trust for the world community and are
deployed  for  the  benefit  of  developing  countries.  The  Bonn  Guidelines  are  relevant  for  the
CGIAR  centres  to  guide  them  in  their  role  of  users  and  suppliers  of  genetic  resources,
including in helping preventing misappropriations of the materials transferred.

3. 

EC LEGISLATIVE AND POLICY MEASURES ON ABS

As  early  as  1995,  the  European  Commission  funded  a  study  on  potential  measures  to
implement  CBD  Articles  15  and  16  (access  to  and  transfer  of  technology),  the  results  of
which were circulated at CBD COP33. The EC approach to ABS has since  evolved through
negotiations within a variety of multilateral fora, as well as through a range of  measures by
the Community, Member States and individual stakeholder groups.

The EC has not introduced comprehensive legislation governing ABS and related traditional
knowledge.  However,  a  number  of  EC  policy  and  legislative  measures  directly  address  the
CBD provisions on ABS and the traditional knowledge, innovations and practices of local and
indigenous peoples.4

With  respect  to  policy,  the  1998  European  Community  Biodiversity  Strategy5  notes  the
need  for  the  Community  to  promote  appropriate  multilateral  frameworks  for  ABS,  to
encourage the development of voluntary guidelines for ABS and to support countries of origin
of  genetic  resources  in  developing  national  strategies  on  bio-prospecting.  The  2001  EC
Biodiversity Action Plan for Economic and Development Cooperation6 refers, inter alia,
to the need to support capacity-building in developing countries, so as to enable them to share
the  benefits  from  the  utilisation  of  genetic  resources.  The  parallel  EC  Biodiversity  Action
Plan  for  Agriculture  highlights  the  need  for  compensation  to  local  farmers  who  are  the

3

4

5
6

Environmental Resources Management, Identification of Community Measures for the Implementation
of Articles 15 and 16 of the Convention on Biological Diversity: Final Report, Part B. June 1996.
See EC Thematic Report on Access and Benefit-sharing (http://biodiversity-chm.eea.eu.int/ ), submitted
to the CBD Secretariat in October 2002, for a full account of EC measures in this area.
COM (1998) 42.
COM (2001) 162 final.

9

 
                                                
ultimate providers of genetic material for research and breeding activities. Hence the need to
provide them with access to the enhanced material and to share the benefits arising from the
enhancement in a participatory manner.

to 

legal  provision,  Directive  98/44/EC  on  the 

In  relation 
legal  protection  of
biotechnological  inventions7  specifically  takes  into  consideration  ABS.  Recital  27  to  the
Directive encourages patent applications to include information on the geographical origin of
biological material. This provision supports compliance with national legislation in the source
country  of  biological  material  and  with  contractual  arrangements  governing  the  acquisition
and use of that material. Alongside Recital 27, Recital 55 of the Directive requires Member
States to give particular weight, inter alia, to CBD Article 8j, 16.2 and 16.5 when introducing
law, regulations and administrative procedures to implement the Directive. However, recitals,
as such, do not create legally binding obligations for the Member States.

A number of other EC legislative and policy measures contribute to the implementation of the
CBD’s  provisions  on  benefit-sharing.  These 
include  regulations  and  directives  on
geographical indications, which offer some potential for the protection of products related to
TK, and on Community plant variety rights. With regard to the latter, Regulation 2100/94,
as it is the case for Directive 98/44, contains a derogation whereby small farmers do not have
to  pay  any  remuneration  to  the  right-holders  for  the  use  of  seeds  harvested  on  their  own
holdings while other farmers are required to pay an "equitable" remuneration. EC regulations
on  the  conservation  and  characterisation  of  plant  genetic  resources  for  food  and
agriculture  are  also  relevant  as  well  as  measures  in  support  of  research  and  technology
transfer.

4. 

EC STAKEHOLDERS' ACTIONS ON ABS

The  EC’s  existing  array  of  measures  should  be  considered  alongside  other  stakeholder8
initiatives  to  develop  policies  and  codes  of  conduct,  complementary  of  both  the  CBD  and
national ABS legislation.9 Several MS and the European Commission have held or planned to
hold  wide  stakeholder  consultation  with  a  view  to  discuss  the  possible  use  of  the  Bonn
Guidelines.

Scientific research institutions and in particular networks of ex situ collections in the EC have
pioneered institutional policies and Codes of Conduct on ABS, to facilitate the acquisition
and  exchange  of  genetic  resources  in  accordance  with  applicable  national  and  international
law. Such policies and codes of conduct form part of  a  package of measures (for which the
Bonn  Guidelines  provide  a  coherent  framework)  to  assist  in  the  development  and
implementation of ABS arrangements. They constitute an effective measure to increase user
transparency, while providing sufficient flexibility to respond to the circumstances of specific

7
8

9

OJ L 213/13.
The  category  of  actual  or  potential  stakeholders  in  relation  to  ABS  is  certainly  very  wide  and  open-
ended.  Major  groups  that  can  be  identified  include:  several  industrial  sectors  such  as  the
pharmaceutical,  botanical  medicine,  biotechnology,  seeds  and  cosmetic  industry;  the  horticultural
sector; universities and research institutes; gene banks; botanical gardens; indigenous peoples; NGOs in
the environment and development field; etc.
See EC Thematic Report on Access and Benefit-sharing (http://biodiversity-chm.eea.eu.int/ ), submitted
to the CBD Secretariat in October 2002, for a fuller account of EC stakeholder measures in this area.

10

 
                                                
research  sectors  and  users  of  genetic  resources.  Important  initiatives  have  been  taken  by
European botanic gardens,10 microbial culture collections and germplasm collections.

Some  European  pharmaceutical  and  biotechnology  companies  have  developed  corporate
policies on ABS though, with declining interest in some natural products research, these may
be of less importance to corporate strategy in the future. Other sectors, including horticulture
and botanical medicines, continue to exert significant demand for genetic resources but do not
seem to have developed comprehensive corporate or sector-based policies on ABS.

As  with  institutional  policies  and  codes  of  conduct  for  research  institutions  and  ex  situ
collections,  corporate  policies  form  part  of  a  package  of  measures  (for  which  the  Bonn
Guidelines provide a coherent framework) to assist in the development and implementation of
ABS arrangements. They constitute measures which can increase user transparency and good
corporate  citizenship.  Corporate  policies  on  ABS  can  also  contribute  to  the  development  of
companies' R&D strategy, by helping to identify likely partner countries, main suppliers and
collaborators and the monetary and non-monetary cost of partnership.

The EC supports the implementation of institutional policies and codes of conduct on ABS by
stakeholder groups, including for ex situ collections. Specifically, the Commission supported
the  development  of  the  Micro-organisms  Sustainable  Use  and  Access  Regulation
International Code of Conduct (MOSAICC)11 by the Belgian Co-ordinated Collections of
Micro-organisms (BCCM), together with 16 other organisations from around the world.

MOSAICC  aims  at  facilitating  access  to  microbial  resources  and  at  helping  partners  to
develop practical  agreements  when  transferring microbial resources.  It  answers the need  for
easy  transfer  of  microbial  resources  and  the  need  to  monitor  such  transfer.  Access  to
microbial resources is a pre-requisite for the advancement of microbiology while monitoring
is necessary to identify individuals or groups that are entitled to be scientifically or financially
rewarded  for  their  contribution  to  the  conservation  and  sustainable  use  of  the  microbial
resources.

One  of  the  basic  principles  of  MOSAICC  is  to  identify  the  in  situ  origin  of  microbial
resources  via  the  appropriate  procedure  providing  authorization  for  sampling.  The  World
Federation  for  Culture  Collections  (WFCC),  the  European  Culture  Collections  Organisation
(ECCO)  and  the  Microbial  Resources  Centres  Network  (UNESCO-MIRCEN)  support
MOSAICC's  goal  of  putting  in  place  practical  and  universal  procedures  to  implement  ABS
arrangements in accordance with international and national laws.

The  Commission  will  finance  a  follow-up  of  the  MOSAICC  project  aimed  at  providing
validated reliable methods for the value assessment of microbial resources. Such methods are
necessary  to  put  a  socially,  economically  and  environmentally  sound  ‘price’  on  genetic
resources and therefore facilitate benefit-sharing. The project also aims to develop validated
model documents to enable traceability of microbial resources (origin, transfer and transport).

10

11

Important  examples  include  the  "Principles  on  access  to  genetic  resources  and  benefit-sharing  for
participating institutions", developed under the auspices of the Royal Botanic Gardens, Kew, involving
28 botanic gardens from 21 countries <www.rbgkew.org.uk/conservation>; and the International Plant
Exchange Network (IPEN <www.biologie.uni-ulm.de/verband/cbd/list.html>) and its Code of Conduct
for botanic gardens and similar collections governing the acquisition, maintenance and supply of living
plant material.
http://www.belspo.be/bccm/mosaicc

11

 
                                                
Finally,  the  Commission  has  supported  policy  research  on  ABS,  including  on  the
commercial demand for access to genetic resources.12

5. 

THE BONN GUIDELINES

What do they say?

As mentioned above, the Bonn Guidelines may serve as inputs when developing and drafting
legislative, administrative or policy measures as well as contracts and other arrangements for
ABS.  They  are  a  voluntary  instrument  intended  to  gain  support  of  users  and  providers  of
genetic resources and TK. They are flexible in order to be used across a wide range of sectors,
users and national circumstances and are intended to be reviewed and revised as experience is
gained  in  access  and  benefit-sharing.  They  have  a  wide  scope  of  application  covering  all
genetic resources and associated TK, innovations and practices covered by the CBD and the
benefits arising from their use. The Guidelines are conceived as a complementary instrument
vis-à-vis  existing  international  instruments  in  related  areas  such  as  the  FAO  International
Treaty on Plant Genetic Resources for Food and Agriculture.

The  Guidelines  aim,  inter  alia,  at  contributing  to  the  conservation  and  sustainable  use  of
biological  diversity,  at  providing  Parties  and  stakeholders  with  a  transparent  framework  to
facilitate  access  to  genetic  resources  and  ensure  fair  and  equitable  benefit-sharing;  at
providing  guidance  to  Parties  in  the  development  of  access  and  benefit-sharing  regimes;  at
informing the practices and approaches of  users and providers  in  access and benefit-sharing
arrangements.

The  Guidelines  identify  roles  and  responsibilities  of  different  actors  in  the  ABS  area.  They
call  for  the  designation  of  national  ABS  focal  points  which  should  be  listed  on  the  CBD
Biodiversity Clearing House (BCH) and should provide information to applicants for access
to genetic resources on procedures for obtaining Prior Informed Consent (PIC) and Mutually
Agreed  Terms  (MAT)  as  well  as  on  competent  national  authorities,  indigenous  and  local
communities and relevant stakeholders. In addition, competent national authorities may be
nominated to grant access and provide advice on the ABS process under national legislation.

The  Guidelines  recognise  that  Parties  and  stakeholders  can  be  both  users  and  providers  of
genetic  resources  and  identify  roles  and  responsibilities  for  Parties  which  are  countries  of
origin  of  genetic  resources,  for  users  and  providers  and  for  Parties  with  users  of  genetic
resources under their jurisdictions.

Countries of origin, or other Parties which have acquired the genetic resources in accordance
with the Convention, are mainly called upon to control the conformity of their national legal
framework with the CBD, to report on access application to the BCH, to develop participatory
mechanisms  for  stakeholders  and  indigenous  and  local  communities  while  ensuring  that
environmental  consequences  of  access  activities  are  taken  into  account  by  stakeholders.
Providers are urged to only supply genetic resources and/or TK when they are entitled to do
so and to avoid arbitrary access restrictions.

12

ten Kate, K. and Laird S.; The Commercial Use of Biodiversity (1999) Earthscan, London. This study
was sponsored by the European Commission

12

 
                                                
A comprehensive list of measures to be taken by users and by countries with users under
their jurisdiction is also  provided.  These  measures  will be dealt with in  some  detail  in  the
following paragraphs as they are primarily addressed to users located in developed countries.
However, as developing countries increasingly become themselves users of genetic resources,
these measures are relevant to them too.

The  Guidelines  also  contain  provisions  emphasising  the  importance  of  involvement  and
participation of stakeholders in the development and implementation of ABS arrangements
and  set  out  the  different  steps  in  the  ABS  process:  the  basic  principles  and  elements  for  a
prior informed consent system; the basic requirement for and an indicative list of mutually
agreed terms; the possible types of benefits and mechanisms to share them. An Appendix to
the  Guidelines  also  suggests  elements  for  Material  Transfer  Agreements  of  genetic
resources and related TK.

6. 

HOW TO IMPLEMENT THE BONN GUIDELINES: EC ACTION CONCERNING PROVIDER
AND COUNTRY OF ORIGIN MEASURES

The MS of the EC are providers of in situ genetic resources and also hold important ex situ
collections.  In  both  cases,  in  situ  and  ex  situ,  access  to  genetic  resources  is  regulated  by  a
wide  range  of  national  laws.  These  include  specific  legal  frameworks  for  access  to  genetic
resources;  indirect  regulation  of  access  through  laws  on  land  ownership;  laws  regulating
conditions to access and exploit State-owned land and natural resources; the law of contracts;
etc.

Indigenous peoples are represented within the borders of the EC in a few regions. Also in this
case the issue of their traditional knowledge is addressed at the national level.13

Under Article 15.5 of the CBD, Parties can choose if they want to subject access to their own
genetic resources to their prior informed  consent. The need for actions at EC level aimed at
harmonising  MS’  legislation  on  access  to  genetic  resources  or  concerning  stakeholders
participation  is  not  apparent  and  will  have  to  be  further  assessed  also  on  the  basis  of  the
experience  gained  with  the  implementation  of  the  Bonn  Guidelines.  In  principle,  national
access  laws  and  participatory  mechanisms  are  best  suited  to  adapt  to  local  realities  and
stakeholders' needs. An action at EC level in this area could be justified by the need to remove
obstacles  to  the  internal  market  in  relation  to  genetic  resources.  However,  the  presence  of
such  obstacles  is  not  apparent  at  the  moment  and,  in  any  event,  the  provisions  of  the  EC
Treaty, in particular Articles 28 and 30, would apply, should such obstacles arise.

7. 

HOW  TO  IMPLEMENT  THE  BONN  GUIDELINES:  EC  ACTION  TO  FOSTER  USER
MEASURES

The  EC  can  play  an  important  role  in  fostering  the  use  of  the  Bonn  Guidelines  by  a  wide
range  of  stakeholders  who  make  use  of  genetic  resources.  In  the  process  leading  to  the
adoption of this Communication, the  European  Commission  held  a  stakeholder  consultation
with  major  European  stakeholders  groups’  representatives  to  discuss  the  implementation  of
the Bonn Guidelines. The meeting showed that the level of awareness of the CBD and of the
Bonn  Guidelines  varies  considerably  from  one  stakeholder  group  to  the  other.  While  a

13

For instance, for Sami people, indigenous of Northern Sweden and Finland.

13

 
                                                
number  of  botanical  gardens,  agricultural  and  culture  collections  have  been  proactive,  even
anticipating the work of the CBD, in revising their policies in accordance with Article 15 of
the Convention, the biotechnology and pharmaceutical industries are at an earlier stage in the
revision of their policies in this area.

Paragraph  16  b)  of  the  Bonn  Guidelines  highlights,  inter  alia,  the  following  four  types  of
actions users should undertake:

1

2.

3.

4.

seek PIC to access genetic resources by respecting, in particular, indigenous people
customs and values;

respect terms and conditions under which genetic resources were acquired, including
on change of use of the resources;

keep documentary evidence of PIC, origin and use of  and benefits arising  from  the
genetic  resources  and  provide  these  materials  to  third  parties  to  whom  genetic
resources are supplied;

ensure  the  fair  and  equitable  sharing  of  the  benefits  in  conformity  with  mutually
agreed terms.

In principle, users' responsibilities are defined in the mutually agreed terms under contractual
agreements.  The  Bonn  Guidelines  (paragraphs  42-50)  identify  basic  requirements  for
mutually  agreed  terms  and  an  indicative  list  of  them.  Appendix  I  contains  “Suggested
Elements for  Material Transfer Agreements”. A Material  Transfer  Agreement  (MTA)  is  the
document which is normally used to record the obtainment of PIC and to include all terms and
conditions under which the genetic resources  were  acquired. Copies of MTAs  can  be  easily
transmitted to third parties to which the genetic resources are supplied. This would  help the
traceability of the genetic resources and contribute to ensuring the fair and equitable sharing
of the benefits.

The  EC  and  its  Member  States  are  actively  involved  in  the  process  aimed  at  developing  a
standard MTA in the framework of the Multilateral System of the IT-PGRFA and are at the
origin of the above mentioned Appendix I of the Bonn Guidelines. The Commission strongly
recommends  that  stakeholders  -  including  companies,  universities  and  other  research
institutions  -  make  full  use  of  Material  Transfer  Agreements  as  a  tool  to  live  up  to  their
responsibilities  as  identified  in  the  Guidelines.  The  Commission  also  encourages  the
development of standardised MTAs for different uses in different sectors.

Furthermore,  the  Commission  stresses  the  importance  of  the  development  of  stakeholders'
codes of conduct, based on the Bonn Guidelines, as a means to adjust the Guidelines to the
needs  of  different  sectors  dealing  with  genetic  resources  and  to  make  the  actions  indicated
under  16  b)  above  become  stakeholders’  common  practice.  In  developing  such  codes  of
conduct,  it  will  be  important  to  engage  in  an  active  dialogues  with  partners  in  countries  of
origin in order to identify practices which ensure the maximum transparency in the collection
of genetic resources and in subsequent transactions.

Para  16  d)  of  the  Guidelines  invites  Parties  with  users  within  their  jurisdiction  to  support
compliance by users with the requirements in paragraph 16 b) above by taking, inter alia, the
following actions:

14

 
1.

2.

3.

4.

5.

6.

informing users of their obligations;

encouraging  the  disclosure  of  the  country  of  origin  of  the  genetic  resources  in
intellectual property rights applications;

preventing the use of genetic resources obtained without PIC;

co-operating to address infringements of ABS agreements;

setting up voluntary certification schemes for organisations abiding by ABS rules;

discouraging unfair trade practices.

The actions already taken or envisaged by the Commission in relation to each of these 6
points are presented below.

7.1. 

Informing users of their obligations and discouraging unfair trade practices

As indicated above, the EC has already in the past taken some initiatives aimed at informing
users of their obligations under the CBD and at facilitating their fulfilment. For instance, the
Commission has supported policy research on ABS, including on the commercial demand for
access to genetic resources.14

One  of  the  objectives  of  the  above-mentioned  stakeholder  meeting  organised  by  the
Commission  and  of  the  present  Communication  is  also  to  raise  stakeholders'  awareness  of
their obligations under the CBD. However, the Commission considers that this can be pursued
further by envisaging the following measures:

– 

– 

– 

14

The  establishment  of  a  European  network  of  ABS  focal  points  and/or  Competent
National  Authorities  -  building  on  existing  networks  -  which  could  be  connected,
inter  alia,  through  the  EC  Biodiversity  Clearing  House  Mechanism  (EC-CHM).  To
date,  most  MS  have  appointed  an  ABS  focal  point.  The  constitution  of  an  effective
network among them –without attempting to harmonise the content and structure of
such  focal  points-would  not  only  help  those  who  may  want  to  access  genetic
resources  held  in  the  EC  but  also  contribute  to  identify  relevant  stakeholders  at
national level and raise their awareness about the Bonn Guidelines.

The creation of a specific section of the EC Biodiversity Clearing House Mechanism
devoted  to  the  issue  of  ABS.  Such  a  section  could  contain  the  text  of  the  Bonn
Guidelines  together  with  an  explanation  of  their  relevance  to  different  European
stakeholders’ profiles. The EC-CHM could become an important channel to inform
stakeholders on their rights and obligations internationally, including in relation to
other international instruments such as the IT-PGRFA; in the EC, and in the MS. To
this end, appropriate  links with, inter alia,  the CBD and  MS’  Biodiversity Clearing
Houses could be provided.

Publicising  the  EC-CHM  website  widely  and  writing  to  all  relevant  stakeholders
groups encouraging them to register on the EC-CHM and to provide copies of their
own policies, codes of conduct, guidelines, principles, case studies, MTAs examples,
etc.,  related to ABS. The  listing in a  register  on  the  BCH  of  companies/institutions

See  ten  Kate,  K.  and  Laird  S.;  The  Commercial  Use  of  Biodiversity  (1999)  Earthscan,  London.  This
study was funded by the European Commission

15

 
                                                
which  are  users  of  genetic  resources  and  the  presentation  of  their  policies  could
prove beneficial for both users and providers. It would provide them with potential
new markets for genetic resources. It could give providers a more accurate idea of
the type and amount of benefits, including technology transfers, that can realistically
be obtained from the use of different types of genetic resources. It is often difficult to
predict beforehand the benefits which could arise from genetic resources. Therefore,
explanations  provided  by  users  on  the  EC  CHM  could  avoid  creating  unrealistic
expectations which in turn could hinder access. The register could also enhance the
profile  of  users  since  the  registration  of  a  fully-fledged  ABS  policy  in  compliance
with the CBD would be evidence of a good sense of corporate social responsibility.

– 

The  integration  of  the  ABS  issue  as  an  item  to  be  tackled  by  the  multi-stakeholder
the  Commission  Communication  on  Corporate  Social
forum  created  by 
Responsibility (CSR)15 and which will report on its work to the Commission in 2004.
CSR is a concept whereby companies integrate social and environmental concerns in
their  business  operations  and  in  their  interaction  with  their  stakeholders  on  a
voluntary  basis.  By  following  internationally  agreed  guiding  principles  and
standards, of which the Bonn Guidelines are an example, and including them in their
environmental reporting activities, multinational enterprises can contribute to ensure
that international trade functions in a more sustainable way.

The contribution of CSR to sustainable development, in particular in developing countries, is
one  of  the  issues  which  the  CSR  Communication  invited  the  multi-stakeholder  forum  to
address  and  agree  guiding  principles  on.  The  multi-stakeholder  forum  identified  three  main
ways  to  promote  transparency  and  convergence  of  CSR  practices  and  instruments:  1)  the
exchange of experience and good practice at EU level; 2) bringing together existing initiatives
in  different  sectors  seeking  to  establish  a  common  EU  approach,  and  3)  identifying  areas
where  additional  action  is  needed.  All  of  these  three  actions  would  be  beneficial  in  dealing
with  the  ABS  issue.  The  latter  could  be  the  subject  of  theme-based  round  tables  to  which
relevant stakeholders, experts and representatives of developing countries  should be  invited.
This would not only raise stakeholders’ awareness of their CBD-related obligations but also
contribute to discouraging practices which are not in conformity with the CBD and the Bonn
Guidelines including unfair trade practices.

7.2. 

Encouraging  the  disclosure  of  the  country  of  origin  in  intellectual  property
rights applications

As  mentioned  above,  The  EC  Directive  98/44/EC  on  the 
legal  protection  of
biotechnological  inventions  specifically  takes  into  consideration  ABS.  Recital  27  to  the
Directive encourages patent applications to include information on the geographical origin of
biological material. This provision supports compliance with national legislation in the source
country  of  biological  material  and  with  contractual  arrangements  governing  the  acquisition
and  use  of  that  material.  However,  this  is  without  prejudice  to  the  processing  of  patent
applications or the validity of rights arising from granted patents.

15

COM(2002) 347 final.

16

 
                                                
7.3. 

Preventing the use of genetic resources obtained without PIC: the possible role
of disclosure requirements and of a certificate of origin.

Article 15.5 of the CBD provides that access to genetic resources shall be subject to the PIC
of the Contracting party providing such resources, unless otherwise determined by that Party.
Therefore,  companies/institutions  conducting  bio-prospecting  activities  are  expected  to
require  the  PIC  of  the  provider  countries.  The  latter  are  the  best  placed  to  enforce  the  PIC
requirement on their territory. The Commission strongly encourages stakeholders from the EC
to respect the prior informed consent requirements of provider countries. The respect of PIC
will be facilitated if provider countries clearly identify who, under their legal order, is entitled
to give prior informed consent.

A number of mechanisms are under discussion in different international fora which could be
implemented by  countries with users under their  jurisdiction in order to  help preventing  the
use of genetic resources obtained without PIC. Such mechanisms could be envisaged for the
different phases of the ABS process: the access phase (in the field or from ex situ collections),
the import of the genetic resources, the research and development phase, the application for
intellectual  property  rights,  the  final  product  approval  etc.  International  discussions  in  the
CBD,  in  the  TRIPs  Council  and  in  the  WIPO  IGC  have  focussed,  in  particular,  on
mechanisms  related  to  intellectual  property  such  as  a  disclosure  requirement  for  patent
applicants and on a certificate of origin for genetic resources and TK.

Existing disclosure requirements

The EC is conscious of the fact that the intellectual property system “plays a practical role in
promoting the sharing of the benefits from access to genetic resources and associated TK”.16
Requirements that can entail the disclosure of origin of genetic resources and TK already exist
under  EC  law  and  European  intellectual  property  law.  In  line  with  established  patent
principles, three  cases  are  provided  for:  the  so-called  enabling  disclosure;  the  relevant  prior
art; and the identification of the true inventor(s).

In  relation  to  the  enabling  disclosure,  Article  13(1)(b)  of  the  EC  Directive  98/44/EC  states
that  where  an  invention  involves  the  use  of  or  concerns  biological  material  which  is  not
available to the public and which cannot be described in a patent application in such a manner
as to enable the invention to be reproduced by a person skilled in the art, the description shall
be considered inadequate for the purpose of patent law unless the application as filed contains
such  relevant  information  as  is  available  to  the  applicant  on  the  characteristics  of  the
biological  material  deposited.  Therefore,  in  case  of  resources  which  are  rare  or  exotic,  the
disclosure of the country of origin may be necessary17 in order to allow a person skilled in the
art to reproduce the invention. This is not the case for resources that are readily available.

16

17

WIPO  Draft  technical  study  on  disclosure  requirements  related  to  genetic  resources  and  traditional
knowledge,  document  prepared  by  the  secretariat  for  the  5th  session  of  the  Inter-governmental
Committee  on  Intellectual  Property  and  Genetic  Resources,  Traditional  Knowledge  and  Folklore,
WIPO/GRTKF/IC/5/10, Annex I, 8.
There is no automatic link between the exotic origin of a genetic resource and the obligation to disclose
its origin. One can imagine that, in some cases, a person skilled in the art can be able to reproduce an
invention  without  indication  of  the  source  of  origin  of  the  genetic  resource  and  only  by  using
information contained in the application.

17

 
                                                
With  regard  to  relevant  prior  art,  the  ‘background  art’  that  typically  must  be  disclosed  in
patent applications may include references to traditional uses of the biological material and its
properties in its country of origin. Rule 27(1)(b) of the European Patent Convention requires
that the content of the description of the patent should indicate the background art which, as
far as known to the applicant, can be regarded as useful for understanding the invention, for
drawing  up  the  European  search  report  and  for  the  examination,  and,  preferably,  cite  the
documents reflecting such art.

Concerning  the  identification  of  the  true  inventor,  Article  81  of  the  European  Patent
Convention requires that “the European patent application shall designate the inventor. If the
applicant  is  not  the  inventor  or  is  not  the  sole  inventor,  the  designation  shall  contain  a
statement indicating the origin of the right to the European patent". If a patent is granted for an
invention which is substantially based on existing TK - of a kind which is itself inventive - belonging to
a person  or group of persons which are not identified as inventors, this could have substantial
legal implications, such as invalidation or revocation of the patent. In other words, remedies
are  available  under  existing  patent  provisions  to  TK  holders  whose  TK  has  been
misappropriated.

Moreover, under EC law, a disclosure requirement is also foreseen under Regulation 2100/94
on  Community  Plant  Variety  Rights.  Article  50  of  the  regulation  requires  applicants  for  a
community  plant  variety  right  to  state  the  geographic  origin  of  the  variety.  However,  this
disclosure is limited to the variety and does not cover the parent material from which the new
variety was developed.

It is apparent that the above-mentioned disclosure requirements may contribute to preventing
the  use  of  genetic  resources  or  TK  without  PIC.  However,  in  particular  in  the  case  of  the
enabling disclosure described above, it is clear that the disclosure of the country of origin of
the  genetic  resources  will  not  take  place  in  all  cases.  The  existing  requirements  under
intellectual property law do not provide for an undertaking or evidence of PIC to be furnished.

Possible further disclosure requirements

In order to make intellectual property and biodiversity regimes mutually supportive, use could
be  made  of  the  flexibility  which  already  exists  under  intellectual  property  law.  In  the
framework of the on-going discussion in the TRIPs Council on the relationship between the
TRIPs  Agreement  and  the  CBD,  the  EC  has  agreed18  to  examine  and  discuss  the  possible
introduction  of  a  system,  such  as  a  self-standing  disclosure  requirement,  that  would  allow
Members  to  keep  track,  at  global  level,  of  all  patent  applications  with  regard  to  genetic
resources for which they have granted access.

Therefore,  the  EC  and  its  MS  have  already  shown  their  willingness  to  contribute
constructively  to  find  a  multilateral  approach  to  the  issue  of  disclosure.  Multilateral  action
would  be  more  effective  as  disclosure  requirements  would  better  achieve  their  purpose  if
implemented widely. Moreover, a multilateral solution would also create a level-playing field
for  all  patent  applicants.  However,  multilateral  solutions  often  need  a  long  time  to  be
developed and are dependent on someone taking the lead.

18

Communication by the EC and its Member States to the TRIPs Council on the review of Article 27.3
(b) of the TRIPs Agreement, and the relationship between the TRIPs Agreement and the Convention on
Biological Diversity and the protection of traditional knowledge and folklore.

18

 
                                                
In the context of the implementation of the Bonn Guidelines there is indeed a possibility for
Parties to the CBD of introducing a disclosure requirement in their legal systems, unilaterally,
independently from the setting up of an international system. The EC is a regional group of
industrialised  countries:  action  at  EC  level,  while  not  being  a  substitute  for  a  multilateral
system,  would  have  important  practical  effects  as  it  would  apply  to  a  wide  range  of  patent
applicants.  In  this  respect,  a  disclosure  requirementwould  be  helpful.  Provider  countries
would also know that a disclosure requirement would help them enforcing their national laws
on prior informed consent. This could in fact comfort a policy of giving European companies
better access.

Thus  the  Commission  believes  that  there  should  be  a  debate  over  the  possible  unilateral
development, under EC law, of a self-standing obligation for patent applicants to disclose
the  origin  of  genetic  resources,  along  the  line  of  what  has  been  proposed  in  the  above-
mentioned Communication to the TRIPs Council. Therefore, the information to be provided
by  patent  applicants  would  be  limited  to  information  on  the  geographic  origin  of  genetic
resources or TK  used in the invention which they  know  or  have  reason  to  know.  When  the
country  of  origin  is  not  known,  the  patent  applicants'  obligation  would  be  to  indicate  the
research centre, gene bank or entity from which they acquired the resources.

Such a disclosure requirement could not be retroactive and could not act, de facto or de jure,
as an additional formal or substantial patentability criterion. Legal consequences of the non-
respect  of  the  requirement  would  need  to  lie  outside  the  ambit  of  patent  law,  such  as  for
example  in  civil  law  (claims  for  compensation)  or  in  administrative  law  (fee  for  refusal  to
submit information to the authorities or for submitting wrong information). Furthermore, the
Commission intends to also look into the feasibility of a similar disclosure requirement in the
context of plant variety rights.

Should  a  disclosure  requirement  be  developed  at  EC  level,  this  should  not  diminish  the
commitment  of  the  EC  to  contribute  constructively  to  finding  multilateral  solutions.  The
Commission  believes  that  the  EC  and  its  MS  should  be  ready  to  discuss,  in  the  relevant
international  fora,  the  possibility  of  introducing  under  intellectual  property  law  the  same
disclosure  requirement  presented  above  but  as  a  formal  condition  for  patentability  and
not only as a self-standing obligation. The consequences of the non-respect of such a formal
requirement could lie both within and outside the patent law system. In relation to patent law,
they could include the non-processing of the patent application until the patent applicant has
provided  the  required  declaration,  and  the  invalidation  or  revocation  of  the  patent  if  the
incorrect  declaration  of  the  source  is  due  to  fraudulent  intention.  Outside  patent  law,  they
could give rise to distinct sanctions to be determined at national level as in the case of a self-
standing obligation.

The  formal  disclosure  requirement  would  not  require  patent  offices  to  judge  whether  prior
informed  consent  requirements  have  been  complied  with  at  the  point  of  access.  The  latter
could be a daunting task for patent offices, as it would entail the enforcement from their part
of  legal  obligations  established  under  another  jurisdiction.  Such  a  task  would  be  more
appropriately left to courts where the validity of a patent can be challenged. However, even if
the failure to meet the disclosure requirement does not have immediate consequences during
the patent examination (e.g. because the fraudulent behaviour is not discovered), still it could
have major consequences when the patent is enforced.

19

 
A complementary measure that could make the disclosure requirement an even more effective
incentive to comply with PIC would be the introduction of a simple notification procedure to
be followed by patent offices. The latter, every time they receive a declaration disclosing the
origin  of  genetic  resources  or  TK,  could  notify  this  information  to  the  Clearing-House
Mechanism of the CBD. The information would therefore be available to all CBD Parties as
well  as  to  the  general  public.  The  introduction  of  such  measure  should  not  lead  to  an
unnecessary administrative burden for the patent offices.

The  two  types  of  disclosure  requirements  described  above  would  be  a  strong  incentive  to
comply with the prior informed consent required under the law of the provider country. In the
case  of  a  formal  disclosure  requirement,  whose  consequences  would  also  lie  within  patent
law, it will be necessary to clarify whether it could be accommodated within the existing rules
of the TRIPs Agreement, the Patent Co-operation Treaty (PCT) and of the Patent Law Treaty
(PLT).19

The certificate of origin

Another  means  to  help  preventing  the  use  of  genetic  resources  and  TK  without  the  PIC  of
their  provider  could  be  a  certificate  of  origin.  The  latter  is  not  only  relevant  in  the  field  of
intellectual  property  but  in  relation  to  the  whole  chain  of  the  ABS  process:  it  could
accompany the genetic resources from the collection phase until the marketing of the product
which makes use of them. However, an entry point for checking that PIC has been provided is
constituted  by  the  possibility  of  requiring  patent  applicants  to  present  a  certificate  of  origin
when they apply for a patent on an invention which makes use of genetic resources or TK. In
this way, they  would not  only disclose  the  origin of  genetic  resources  and  TK,  as  proposed
above, but also provide evidence of the fact that they were lawfully acquired.

CBD Decision VI/24 C 3 f) recognises the need for further information gathering and analysis
on  a  range  of  issues  including  the  "feasibility  of  an  internationally  recognised  certificate  of
origin  system  as  evidence  of  prior  informed  consent  and  mutually  agreed  terms".  National
access laws in the different countries Parties to the CBD vary widely where they exist at all.
The  same  applies  to  the  requirements  that  access  applicants  have  to  fulfil.  Therefore,  at
present, there is no single document which could be used in all Parties to the CBD in order to
provide evidence of PIC. In some cases, such document would be a MTA, in some others an
authorisation provided by a public authority or a concession or a licence, etc.

If  a  requirement  to  submit  documentary  evidence  of  PIC  for  patent  applicants  were  to  be
introduced,  it  would  be  facilitated  by  a  clear,  simple  and  harmonised  system  for  certifying
access  such  as  a  standard  MTA.  However,  genetic  resources  and  their  uses  can  be  very

19

The  Patent  Co-operation  Treaty  (PCT)  determines  the  standards  that  apply  to  form  and  content  of
international patent applications. Rule 51 bis of the PCT provides (under (i)(a)) that “the national law
applicable by the designated Office may require the applicant to furnish, in particular: (i) any document
relating to the identity of the inventor, (ii) any document relating to the applicant’s entitlement to apply
for  or  be  granted  a  patent”.  Article  30  of  the  PCT,  on  the  confidential  nature  of  the  international
application,  prohibits  national  offices  to  allow  access  to  the  international  application  by  third  parties
before  certain  dates  determined  therein,  unless  requested  or  authorised  by  the  applicant.  In  addition,
Article 6 of the Patent Law Treaty (PLT) states that no Contracting Party shall require compliance with
any requirement relating to the form and contents of an application different from or additional to those
contained in the PCT (Article 6.1 i) and ii)) or those prescribed in the implementing regulations of the
PLT (Art. 6.1 iii)). Article 10 of the PLT is also relevant  since it addresses the consequences of non-
compliance with formal requirements for patent applications. Non-compliance may not be a ground for
revocation or invalidation of a patent except when it occurred as a result of fraudulent intention.

20

 
                                                
diverse,  and  it  is  not  realistic  to  develop  a  'one  fits  all'  MTA.  It  will  be  necessary  to  let
stakeholders enjoy sufficient flexibility in order to adjust an MTA on a case by case basis.

Therefore, the Commission considers that the EC and its MS should be open to further discuss
in the CBD framework the development of such a certificate of origin. However, whatever the
outcome  of  these  discussions,  the  EC  stresses  the  fact  that  if  a  requirement  for  patent
applicants to provide documentary evidence of PIC were to be introduced, it should be limited
to a transparency obligation. In other words, it shall not be for patent offices to examine the
substantive  aspects  of  the  document:  they  would  limit  their  control  to  the  provision  of
evidence  of  PIC.  Courts  would  do  a  substantive  assessment  of  these  documents  in  case
litigation arose. Moreover, it will be necessary to analyse whether and how such certificate of
origin could be accommodated within the existing body of international intellectual property
law20.

7.4. 

Co-operating with CBD Parties to address infringements of ABS agreements

Addressing infringement of ABS agreements often involves a 'choice of law', i.e. determining
what is the applicable law and the competent forum. These issues are in principle settled at the
moment  in  which  PIC  is  provided  for  access.  For  instance,  MTAs  should  contain,  as
suggested by the Bonn Guidelines, provisions on the choice of law and on dispute settlement.
If this is not the case, criteria exist under private international law to determine the applicable
law and forum.

However,  problems  can  arise  even  when  it  is  clear  what  are  the  applicable  law  and  the
appropriate forum. In some cases, even when the law and jurisdiction of the provider country
are  established  (e.g.  by  national  law  or  by  contract),  it  might  be  difficult  to  enforce  a
judgement establishing the violation of national law by a foreign company when the latter has
no assets in the provider country. On the other hand, when the competent forum is that of the
user, courts will be called upon to enforce within their jurisdiction foreign laws.

These  examples  show  that  enforcement  problems  in  relation  to  ABS  national  laws  and
agreements can well arise. Possibilities to prevent these situations need to be further studied
on  the  basis  of  experience  gained  under  international  law  in  the  enforcement  of  foreign
judgements and in the intellectual property field in relation to the issue of entitlement to apply
for or be granted a patent.

One  alternative  dispute  resolution  system  that  could  help  addressing  these  problems  is
arbitration.  For  instance,  it  could  prove  helpful,  under  the  terms  of  an  MTA,  for  parties  to
agree to submit their disputes to a specific arbitration system available under international law
whose decisions would be enforceable in a great number of States. Arbitration procedures are
normally  faster  and  less  expensive  than  court  proceedings  and  could  therefore  prove  more
attractive than court proceedings.

20

In particular, Article 6.6 of the PLT should be taken into account. Under this provision, a Contracting
Party  may require  that  evidence  in  respect  of  any  matter  referred  to  in  Article  6  paragraph  (1)  or  (2)
(form and contents of an application, and request form) or in a declaration of priority, be filed with its
Office in the course of the processing of the application only where that Office may reasonably doubt
the veracity of that matter.

21

 
                                                
Another  problem  that  could  arise  in  relation  to  ABS  disputes  concerns  the  possibility  for
providers  to  obtain  information  and  access  to  justice  in  the  countries  where  the  users  are
located. In this respect, countries' ABS focal point could play a facilitator role by providing
information, including on the legal system of their country. Moreover, controversies between
providers and users located in different countries could be presented to the CBD Conference
of the Parties and mediated by national authorities.

7.5. 

Developing voluntary certification schemes

In  relation to the possibility  of  developing  voluntary  certification  schemes  for  organisations
abiding  by  ABS  rules,  the  EC  Eco-Management  and  Audit  Scheme  (EMAS)  offers  an
interesting  potential.21  EMAS  is  a  voluntary  scheme  for  organisations  willing  to  commit
themselves  to  evaluate  and  improve  their  environmental  performance.  It  is  open  to  any
organisation in the public and in the private sector in the EU, in the European Economic Area,
and  in  accession  countries  (on  a  provisional  basis).  The  use  of  a  voluntary  certification
scheme  is  not  to  be  read  as  a  dilution  of  users’  obligations  under  the  CBD.  Such  a  scheme
would serve the purpose of helping users to improve their overall environmental performance,
including in relation to ABS but would not alter their legal obligations.

Under  EMAS,  ‘significant  environmental  aspects’  arising  from  activities,  products  and
services over which an organisation has management control or influence are to be identified
in  accordance  with  Annex  VI.  The  latter  requires  organisations  to  consider  both  direct  and
indirect environmental impacts and mentions among the former ‘use of natural resources and
raw  materials’  and  ‘effects  on  biodiversity’.  Significant  environmental  aspects  are  at  the
centre of an organisation’s management system and of the evaluation and improvement of its
environmental performance by setting objectives and targets. They are also relevant within the
environmental statement that organisations have to prepare in accordance with Annex III.

The Commission has developed Guidance on the identification of the environmental impacts
and  assessment  of  their  significance.22  Companies  and/or  institutions  dealing  with  genetic
resources and related TK and wishing to register for EMAS should identify significant direct
and  indirect  impacts  of  their  activities  on  the  conservation  and  sustainable  use  of  genetic
resources and related TK.

Therefore,  the  principles  contained  in  the  Bonn  Guidelines  could  be  incorporated  in
organisations’ environmental policies and environmental management system to be developed
under EMAS and could then be reflected in their environmental statement. The independent
environmental verifiers accredited under EMAS would control the reliability, credibility and
correctness  of  the  data  and  information  in  the  environmental  statement.  The  Commission
could  raise  the  awareness  of  national  bodies  competent  for  the  registration  of  organisations
under EMAS with regard to the CBD requirements to be fulfilled by companies dealing with
genetic resources.

21

22

Regulation  (EC)  No  761/2001  of  the  European  Parliament  and  of  the  Council  of  19  March  2001
allowing voluntary participation by organisations in a Community eco-management and audit scheme
(EMAS), OJ L 114/1.
Commission  Recommendation  No  2001/680/EC  of  7  September  2001  on  guidance  for  the
implementation  of  Regulation  (EC)  No  761/2001  of  the  European  Parliament  and  of  the  Council
allowing voluntary participation by organisations in a Community eco-management and audit scheme
(EMAS), OJ L 247/1.

22

 
                                                
The application  of  EMAS to the ABS  field  could  also  contribute  positively  to  the  on-going
debate  in  the  CBD,  on  the  setting  up  of  an  international  certification  system  for  genetic
resources.  It  could  provide  arguments  in  favour  of  using  the  international  standard  ISO
14001:1996, in particular for organisations outside the EU, if this standard was enhanced by a
number of important additional elements.

The EMAS Regulation contains ISO 14001 as its basic management system in its Annex 1-A
and  goes  beyond  ISO  in  relation  to  public  transparency,  credibility  and  environmental
performance.  These  EMAS  features  concern,  inter  alia:  (i)  the  environmental  statement  of
EMAS,  (ii)  a  public  register  of  participating  organisations  in  each  country,  (iii)  legal
compliance with other (national) environmental legislation and (iv) the obligation to improve
the  environmental  performance  of  the  organisation  instead  of  improving  the  management
system.  An  ISO  14001  that  would  include  these  elements  would  help  to  achieve  CBD
objectives  outside  the  EU  whereas  EMAS  would  be  used  within  the  EU.  Another  option
would be to extend EMAS to other countries and world regions. The Commission is presently
investigating whether and how this can be achieved.

8. 

EC DEVELOPMENT AND RESEARCH POLICIES

Another avenue that the Commission will pursue in order to implement the Bonn Guidelines
in the Community and to foster their implementation in third countries is their integration into
the EC development and research policies.

With regard to development policy, the Commission will examine means to incorporate into
its standard contracts for economic/development co-operation the basic principles of the Bonn
Guidelines  when  such  contracts  involve  the  use  of  genetic  resources  and/or  traditional
knowledge.

Moreover, the Commission has already taken some policy initiatives in the area of ABS and
development  which  have  the  potential  of  contributing  to  the  implementation  of  the  Bonn
Guidelines in developing countries.

In the Biodiversity Action Plan for Economic and Development Co-operation,23 aimed at
integrating biodiversity  into development  co-operation  projects  and  programmes  -  including
through support to NBSAPs - section 3.4 addresses  the  ‘Equitable Sharing of the Costs  and
Benefits from Biodiversity Use’.

To link the CBD’s objective of equitable benefit-sharing  with the international development
target on poverty, the Action Plan goes beyond the CBD’s wording by incorporating costs as
well  as  benefits,  and  ecosystem  and  species  levels  of  biodiversity  in  addition  to  genetic
resources. Actions 11 and 12 specify support for, amongst others, national capacity-building
in  defining  biodiversity-related  intellectual  property  rights  and  formulating  laws  enabling
equitable  benefit-sharing,  as  well  as  the  development  of  participatory  frameworks  for  and
capacity  building  of  community-based  organisations  and  NGOs  in  negotiating  equitable
benefit-sharing.  Action  13  supports  improvements  of  legal  frameworks  to  give  more  secure
ownership of, and access to, land and natural resources for local people.

The Commission is presently assessing the implementation of this Action Plan and a report is
planned for mid-2004.

23

COM(2001) 162 final.

23

 
                                                
Furthermore,  in  2002  the  Commission  adopted  the  Communication  on  Life  Science  and
Biotechnology.  A  Strategy  for  Europe.24  The  latter  contains  an  Action  Plan  which
specifically addresses the issue of access and benefit-sharing in its Action 26 which provides
the following:

"The Commission and the Member States will support the conservation and sustainable use

of genetic resources in developing countries and their equitable sharing of benefits arising

from their use by:

a)  supporting  the  development  and  enforcement  of  effective  measures  to  conserve,  to  use
sustainably and to provide access to genetic resources and traditional knowledge, as well
as to share equitably the benefit arising from them, including income generated by intellectual
property  protection.  Support  for  local  communities  is  vital  to  conserve  indigenous
knowledge and genetic resources.

b) supporting the participation of delegates from developing countries in the negotiations
of relevant International Conventions.

c) supporting measures to promote greater regional co-ordination in legislation to minimize
disparities  in  access,  benefits  and  also  trade  in  products  derived  from  genetic  resources,  in
accordance with international commitments".

In  the  field  of  research,  under  the  Sixth  Framework  Programme  for  Research  and
Technological  Development  (2000-2006),  the  EC  supports  research  and  technological
development related to genetic resources, including actions supporting the implementation of
the above-mentioned Action Plan on Life Science and Biotechnology.

According  to  the  decision  1513/2002/EC  of  the  European  Parliament  and  the  Council25
research activities carried out within the Sixth Framework Programme have, where relevant,
to  respect  international  conventions  and  codes  of  conduct,  as  well  as  EU  and  national
legislation. Therefore, the CBD and the Bonn Guidelines are among the references to be taken
into account by applicants when submitting research proposals for funding under priority 5 -
Food quality and safety.

The  full  implementation  of  the  above  mentioned  actions  in  the  field  of  development  and
research  policy,  will  contribute  to  the  response  from  the  EC  to  the  capacity  building  needs
identified  by  the  CBD  Draft  Action  Plan  on  Capacity  Building  for  Access  to  Genetic
Resources  and  Benefit-sharing.26  The  latter  identified,  inter  alia,  as  key  areas  requiring
capacity-building: the development of ABS policy, legislative and regulatory frameworks; the
strengthening of participation to decision-making and of negotiation skills; the clarification of
rights and  claims of indigenous  and  local  communities;  the  support  to  indigenous  and  local
communities  to  assess,  inventor  and  monitor  genetic  resources  and  TK;  regional  and  sub-
regional  collaborative  arrangements.  It  will  be  particularly  important  to  help  developing
countries  to  designate  institutions  which  serve  as  focal  point  and/or  Competent  National

24

25

26

COM(2002) 27 final.
Decision No 1513/2002/EC of the European Parliament and of the Council of 27 June 2002 concerning
the sixth framework programme of the European Community for research, technological development
and  demonstration  activities,  contributing  to  the  creation  of  the  European  Research  Area  and  to
innovation (2002 to 2006)
Available on http://www.biodiv.org/doc/meeting.asp?wg=ABSWSCB-01

24

 
                                                
Authority  to  ensure  more  co-ordinated,  timely  and  cost-effective  implementation  of  ABS
measures.

Finally, in response to the Council Conclusions on indigenous peoples of December 2002,27
the European Commission is committed to mainstream indigenous peoples issues into the EC
policies  involving,  where  relevant,  indigenous  peoples  at  all  stages  of  EC-funded  projects'
cycle. The Commission will select a number of pilot countries with EC-funded development
programmes in order to develop more concrete ways to include indigenous peoples as a part
of  civil  society  in  all  phases  of  the  project  cycle  through  partnership,  co-operation  and
consultation. Efforts will be made to promote capacity building of organisations representing
indigenous peoples, including in relation to protection of their traditional knowledge and the
implementation of the Bonn Guidelines.

9. 

EC ACTION IN INTERNATIONAL FORA

The  EC  has  stated  on  several  occasion  its  commitment  to  further  developing  a  transparent
international  regime  on  access  and  benefit-sharing.  The  implementation  of  the  Bonn
Guidelines and, in turn, the achievement of the ABS objective of the CBD depends not only
on  single  Parties'  initiatives  as  those  discussed  in  this  Communication  but  also  on  further
efforts of the international community in a number of international fora.

The latter include the FAO IT-PGRFA, WIPO, the TRIPs Council, and UPOV. The EC and
its Member States already  play an active role in the development of  a  standard MTA in the
context of the IT-PGRFA and in the full implementation of this agreement. In the context of
WIPO, the EC should provide further support to sui generis systems for the protection of TK
and to measures in the field of intellectual property which can contribute to track compliance
with  PIC  as  those  described  above.  The  EC  should  defend  this  position  also  in  the  TRIPs
Council discussions on the relationship between this agreement and the CBD as well as under
the UPOV Convention.

27

Council Doc. 13466/02.

25