INTRODUCTION
This report evaluates the European Commission's advancements in applying the Convention on Biological Diversity's (CBD) regulations regarding access to genetic resources and the fair and equitable sharing of benefits derived from their use (ABS) It also explores initiatives aimed at promoting benefit-sharing from the knowledge, innovations, and practices of indigenous and local communities, highlighting the development of Community policy on the relationship between intellectual property rights (IPRs) and benefit-sharing.
Europe has a rich history as a significant user and provider of genetic resources, crucial for research and product development The continent boasts numerous ex situ collections, such as microbial culture collections and botanic gardens, which are vital for advancing research and technology transfer aimed at conserving and sustainably utilizing genetic resources Many of these institutions have established innovative policies to ensure the legal acquisition, use, and transfer of genetic resources, aligning with the Convention on Biological Diversity (CBD) and relevant national laws, both independently and as part of larger networks that facilitate material exchange.
The commercial demand for access to genetic resources is significant across various sectors, including the seed industry, horticulture, crop protection, pharmaceuticals, biotechnology, and natural personal care and cosmetics While estimating the level of demand within the EU is challenging due to fluctuations aligned with technological advancements, the region boasts considerable commercial R&D capabilities Notably, excluding traditional pharmaceutical and biochemical companies, the European life sciences industry generated revenues of EUR 8,679 million in 2001.
The European Commission (EC) recognizes that access to genetic resources and benefit-sharing (ABS) is crucial for the conservation and sustainable use of biodiversity Since 1995, the EC has explored potential measures to implement the Convention on Biological Diversity (CBD) Articles 15 and 16, with findings presented at CBD COP3 The EC's strategy on ABS has progressed through various multilateral negotiations and has been shaped by legal, policy, and administrative actions from the Community, Member States, and diverse stakeholder groups.
2 Ernst & Young (2001) Eighth Annual European Life Sciences Report.
3 Environmental Resources Management, Identification of Community Measures for the Implementation of
Articles 15 and 16 of the Convention on Biological Diversity: Draft Final Report, Part B June 1996
Prepared for CEC DG XI.
SCOPE, MANDATE AND PREPARATION OF THE REPORT
EC Policy Measures
3.1.1 Policy measures on the conservation and sustainable use of biodiversity
Two sets of policy instruments take account of ABS within the context of the CBD: the
EC Biodiversity Strategy and subsequent Action Plans; and the Guiding Principles and Strategic Approach to Biodiversity in Development These are described below.
Adopted in 1998 as part of the 5th Environmental Action Programme "Towards Sustainability," the European Community Biodiversity Strategy (COM(98)042) focuses on promoting biodiversity conservation Notably, its second strategic theme emphasizes Access and Benefit-Sharing (ABS) and outlines three key recommendations to enhance biodiversity management.
5 Environmental Resources Management, Identification of Community Measures for the Implementation of
Articles 15 and 16 of the Convention on Biological Diversity: Draft Final Report, Part B June 1996
Prepared for CEC DG XI.
The Strategy emphasizes the need for the Community to advocate for suitable multilateral frameworks for Access and Benefit-Sharing (ABS) In response, the European Commission is dedicated to negotiating, ratifying, and implementing the FAO International Treaty on Plant Genetic Resources for Food and Agriculture, along with the Bonn Guidelines on ABS established by Decision VI/24.
The Strategy advises that the European Commission (EC) should encourage voluntary guidelines for bilateral cooperation, particularly in cases where only certain countries require access to specific genetic resources To facilitate this, the EC has been actively supporting the creation of institutional policies and codes of conduct on Access and Benefit Sharing (ABS), exemplified by its involvement in the MOSAICC initiative aimed at microbial collections.
The Strategy emphasizes the importance of assisting countries that are sources of genetic resources in creating national bioprospecting and access strategies, aligned with relevant multilateral frameworks This initiative aligns with the Bonn Guidelines on Access and Benefit-Sharing (ABS), which advocate for the development of comprehensive ABS strategies as part of National Biodiversity Strategies and Action Plans (NBSAPs) Additionally, it supports discussions from CBD COP6 regarding Draft Elements for a Capacity-Building Action Plan, which propose the incorporation of ABS capacity-building within NBSAPs and other related initiatives.
The EC Biodiversity Strategy emphasizes the need for action plans to incorporate biodiversity into various sectors Adopted in March 2002, the EC Biodiversity Action Plan for Economic and Development Cooperation aims to enhance institutional capacities within the European Commission, integrate biodiversity into development projects, and promote coordination within the EU, including support for the Tropical Biodiversity Advisers Group (TBAG) Additionally, the Action Plan focuses on the equitable sharing of costs and benefits associated with biodiversity use.
The Action Plan aligns the CBD's goal of equitable benefit-sharing with international poverty reduction targets by addressing both costs and benefits, while considering ecosystem and species levels of biodiversity alongside genetic resources Actions 10 to 14 emphasize the importance of national capacity-building for defining biodiversity-related intellectual property rights (IPRs) and establishing laws that promote equitable benefit-sharing Additionally, the plan supports the development of community-based organizations and NGOs to enhance their capacity in negotiating fair benefit-sharing agreements.
The EC Biodiversity Action Plan for Agriculture emphasizes the importance of benefit-sharing, particularly acknowledging that developing countries are home to key agricultural biodiversity It advocates for compensating local farmers, who are essential providers of this biodiversity, by ensuring their access to improved materials and sharing the benefits derived from these enhancements Furthermore, it underscores the connection between these benefit-sharing provisions and the broader Action Plan for Economic and Development Co-operation.
The Guiding Principles and Strategic Approach to Biodiversity in Development, crafted by the Biodiversity in Development Project (BDP) in collaboration with the European Commission, DFID, and IUCN, emphasize the fair sharing of biodiversity conservation costs and benefits, aligning with the Biodiversity Action Plan for Economic and Development Cooperation Principle B outlines three key components: support for income-generating activities that promote sustainable use, positive incentives for conservation, and international funding mechanisms for effective biodiversity programs Although not official documents, these principles serve as a framework for the Commission and Member State development agencies to enhance coherence in addressing biodiversity issues.
3.1.2 Policy measures on research and technology transfer
The EC Declaration on the Biodiversity Convention emphasizes the importance of technology transfer and access to biotechnology, aligning with CBD Article 16 and respecting intellectual property rights (IPRs) It encourages the Commission and Member States to utilize the Convention's financial mechanism to facilitate the voluntary transfer of IPRs from European operators, promoting licensing through standard commercial practices while safeguarding property rights Although no other specific EC policy measures target research and technology transfer under the CBD, there are several that may hold relevance.
The Innovation and SME 6 Programme, part of the 5th Research and Technology Development Framework Programme (1998-2002), has the potential to facilitate joint research through ABS agreements Its primary objective is to foster an innovation-friendly environment in Europe by promoting information exchange on research and technology and strengthening connections between research and innovation financing, particularly via the Community Research and Development Information Service (CORDIS).
The Partnership Agreement between the Members of the African, Caribbean and
The Cotonou Agreement between the Pacific (ACP) States and the European Community, along with its Member States, facilitates technology transfer through Access and Benefit-Sharing (ABS) partnerships This collaboration enhances the exchange of genetic resources and traditional knowledge between EU institutions and resource-providing countries.
6 Small and medium-sized enterprise
7
8 knowledge The Compendium on Co-operation Strategies 9 provides for scientific, technical and research co-operation 10
Specifically, the Co-operation Strategy 11 aims to support:
(a) the development and implementation of R&D projects and programmes established by ACP States;
(b) activities aimed at consolidation of appropriate indigenous technology and the acquisition and adaptation of relevant foreign technology;
(c) scientific and technical co-operation between ACP States themselves and between ACP States and other developing countries and the EU; as well as
(d) the design of policies, incentive structures and institutions that enable the development of innovative capacity and competitiveness
The Co-operation Strategy emphasizes the ongoing collaboration between ACP and EC to foster partnerships among knowledge users and generators, informed by a detailed analysis of research capacities and needs It aims to enhance the ability of ACP countries to manage science and technology for sustainable economic and social progress while safeguarding the environment and natural resources This involves building the necessary infrastructure, skills, and knowledge base to enable ACP States to acquire, adapt, and create environmentally sound technologies.
Sectoral agreements on environment and natural resources are also developed in bilateral or regional agreements of the EU with third countries, for instance in the EU-Mexico agreement.
EC Legislation
3.2.1 Legislation relating to IPRs and traditional knowledge
Directive 98/44/EC (6 July 1998) on the legal protection of biotechnological innovations is the only EC legal instrument that specifically takes into consideration the
The CBD promotes the acknowledgment of the geographical origin of biological materials in patent applications for biotechnological inventions This Directive aims to harmonize and clarify national laws, ultimately enhancing patent protection for biotechnological innovations and boosting the competitiveness of the EU's biotechnology sector.
The compendium of cooperation strategies serves as a comprehensive reference, outlining objectives, policy directions, and operational guidelines for various sectors of cooperation, in accordance with Article 20(3) of the ACP-EC Partnership Agreement.
13
Recital 27 of the Directive states that, whereas if an invention is based on biological material of plant or animal origin or if it uses such material, the patent application should, where appropriate, include information on the geographical origin of such material, if known… It is therefore a possible contribution to tracking compliance with prior informed consent (PIC) and mutually agreed terms (MATs) on which access to the resources was granted.
Recital 55 of the Directive emphasizes the importance of CBD Article 8j, urging Member States to consider it when developing laws and regulations for implementation Additionally, Recital 56 acknowledges COP Decision III/17, which highlights the need for further exploration of the connections between intellectual property rights (IPRs), the TRIPs Agreement, and relevant CBD provisions that address technology transfer, biodiversity conservation, sustainable use, and the equitable sharing of benefits from genetic resources.
Recitals 27 and 56 of the Directive serve as non-binding elements aimed at aiding the interpretation of its binding articles Specifically, Recital 27 aligns with CBD Decision VI/24C, which emphasizes the significance of Intellectual Property Rights (IPRs) in implementing Access and Benefit-Sharing (ABS) arrangements This Decision encourages Parties and Governments to promote the disclosure of the country of origin of genetic resources.
Directive 98/44/EC is integrated into the 1973 European Patent Convention (EPC), which governs a unified procedure for granting European patents across Contracting States, including both EU and non-EU countries Although the EPC is not an EC institution, it established the European Patent Office (EPO) responsible for patent grants The EPC’s Implementing Regulations were revised in 1999 to align with Directive 98/44/EC, allowing the directive and its recitals to serve as supplementary interpretative tools for the EPC provisions Consequently, Recital 27 is relevant for the examination of patent applications by national patent offices in EU Member States and the EPO.
Directive 96/9/EC of the European Parliament and Council, established on March 11, 1996, addresses the legal protection of databases but does not explicitly reference the Convention on Biological Diversity (CBD) However, it may assist in meeting the requirements for prior informed consent (PIC) and mutually agreed terms (MAT) related to access The Directive grants copyright protection to database content and may enable the safeguarding of information derived from genetic resources and associated traditional knowledge It defines databases as systematically arranged collections of independent works, data, or materials that are individually accessible For a database to qualify for protection, it must reflect the author's intellectual creation through the selection or arrangement of its contents, and it also extends sui generis protection.
14 European Patents provide protection in more than one Contracting State and have the same effect as national patents.
The Directive empowers authors with the right to authorize various actions, including reproduction, translation, adaptation, distribution, and public performance, as well as the first sale within the Community (Article 5) It also emphasizes the importance of protecting databases that involve significant investments in obtaining, verifying, or presenting content, whether in terms of finance, time, effort, or energy.
Protocol No 3 on the Sami people 17 of the Act of Accession of Austria, Finland and
Sweden's accession to the EU in 1994 may impact the implementation of the Convention on Biological Diversity (CBD), particularly regarding Article 8(j), despite not explicitly mentioning the Convention or traditional knowledge The Protocol ensures that the Sami people retain exclusive rights to reindeer husbandry, overriding certain provisions of the EC Treaty Furthermore, Article 2 of the Protocol allows for the potential expansion of exclusive Sami rights related to their traditional livelihoods.
3.2.2 Legislation governing the conservation and sustainable use of agricultural genetic resources and associated traditional knowledge
The 1996 Global Plan of Action (GPA) aims to conserve and sustainably utilize plant genetic resources for food and agriculture, emphasizing the fair sharing of benefits derived from these resources and associated traditional knowledge This encompasses both in situ and ex situ materials The existing legislative framework of the European Commission supports various activities outlined in the GPA, which may be relevant for the future application of the Bonn Guidelines on Access and Benefit-Sharing (ABS), as per CBD Decision VI/24A.
Council Regulation No 2100/94, established on July 27, 1994, aims to enhance benefit-sharing through Community Plant Variety Rights by requiring applicants to disclose the geographic origin of their varieties It allows farmers to save and reuse proprietary seeds on their own farms, provided they pay a fair yet reduced remuneration to the rights holder, with small farmers being exempt from this fee Additionally, the regulation permits compulsory licensing for public interest purposes, although the specifics of this provision in relation to the Convention on Biological Diversity (CBD) are yet to be clarified.
Regulations relating to the geographic origin and specific character of agricultural products and foodstuffs could work to protect associated traditional knowledge under certain circumstances
Council Regulation No 2081/92, enacted on July 14, 1992, facilitates the registration of designations of origin and geographical indications for agricultural products and foodstuffs These terms refer to the specific region, location, or, in some cases, the country of origin for these products.
16 This grants the holder the right to prevent extraction and re-utilisation of the whole or a substantial part of the contents of a protected database.
17 Indigenous peoples of Northern Norway, Sweden and Finland
18 Gerasimos Apostolatos, EC Activities to implement the Global Plan of Action European Cooperative Programme on Crop Genetic Resource Networks .
The regulation outlines two scenarios where public interest could necessitate compulsory licensing: the need to provide the market with materials that possess specific characteristics and the requirement to encourage ongoing development of enhanced varieties Additionally, a third country can seek registration of a designation within its borders, and the European Commission is empowered to negotiate agreements with these countries to ensure mutual protection of designations.
Council Regulation No 2982/92, enacted on July 14, 1992, allows groups to register the unique characteristics of agricultural products and foodstuffs made from traditional raw materials or defined by their traditional composition and production methods Similar to geographical indications, non-EU countries can request a Community certificate of specific character for their producers.
There are, in addition, potential ABS dimensions to proposed and existing regulations governing seeds, and the conservation and characterisation of PGRFA
Directive 98/95/EC, established on December 14, 1998, focuses on the conservation and sustainable utilization of threatened landraces and varieties that are adapted to local and regional conditions through in situ conservation This Directive provides a legal framework for the cultivation and marketing of these conservation varieties, ensuring their official recognition in the common catalogue It considers results from unofficial tests, practical cultivation experience, and detailed descriptions of the varieties and their denominations.
EC support for ABS policy research and implementation
In 1999, the European Commission initiated research to assess the demand for access to genetic resources for commercial purposes and the equitable sharing of resulting benefits This study aimed to equip governments and organizations with insights into corporate practices and perspectives regarding Access and Benefit-Sharing (ABS) It covered various sectors, including the seed industry, horticulture, crop protection, biotechnology, and natural personal care and cosmetics, with the findings compiled into a published book.
In response to a European Commission tender on June 29, 2001, a study is exploring the connections between intellectual property rights (IPR) regimes and the conservation of genetic resources This research aims to assess how the conservation and sustainable use of biodiversity can support the establishment of IPR or sui generis systems for protecting traditional knowledge, as well as inform the design or limitation of IPRs related to biotechnology The final report is expected to be released by the end of 2002.
To date the EC has supported stakeholder implementation of ABS measures by ex situ collections.
Between September 1997 and June 1999, the EC supported the development of the
Micro-organisms Sustainable Use and Access Regulation International Code of Conduct (MOSAICC) (see also Box 2) The MOSAICC initiative was launched by the
Belgian Co-ordinated Collections of Micro-organisms (BCCM), which led a consortium of 16 organisations involved in microbiology and the use of micro-organisms from the
On June 27, 2002, the European Community adopted Decision 30 COM (2001) 822 final, which established the sixth framework programme for research, technological development, and demonstration activities This programme, running from 2002 to 2006, aims to foster the creation of the European Research Area and promote innovation across member states.
31 ten Kate, K and S A Laird (1999), The commercial use of biodiversity Access to genetic resources and benefit-sharing, Earthscan, London.
MOSAICC is a voluntary code of conduct designed to enhance access to microbial genetic resources in accordance with the Convention on Biological Diversity (CBD) and relevant laws It aims to ensure that material transfers occur under suitable agreements between partners, promoting effective benefit-sharing As a dynamic document, MOSAICC is subject to continuous improvement, similar to the CBD Bonn Guidelines on Access and Benefit-Sharing.
The European Commission has been actively supporting the integration of ex situ collections through the European Biological Resource Centres Network (EBCRN) since November 2001 This initiative addresses the OECD's call for biological resource centres (BRCs) to evolve in support of 21st-century biotechnology The project aims to establish a collaborative network of at least 11 living organism collections, which include nucleic acids and associated data Additionally, the EBRCN will provide a central web platform to share information on legislation regarding access to and distribution of living organisms Currently, the EBRCN is adapting the MOSAICC framework to create its own Material Transfer Agreement, similar to the Uniform Biological Material Transfer Agreement introduced by the NIH and PHS in 1995.
As of November 2001, the EC has also supported BioCASE (Biodiversity Collection
The Access Service for Europe (BioCASE) is a consortium of 34 centers specializing in biodiversity research, biological collections, and informatics, creating a comprehensive network of country nodes This initiative will enhance access to specimens and related data across participating centers, supporting ongoing EU taxonomic projects by serving as a key access point for voucher information Additionally, BioCASE will contribute to the development of the Global Biodiversity Information Facility and the European Commission's CBD Clearing House Mechanism, facilitating access to vital information on European biodiversity and collections from non-European countries.
32 Including the 1997 Budapest Treaty on the International Recognition of the Deposit of Micro-Organisms for the Purposes of Patent Procedure, and the 1994 WTO Agreement on Trade-Related aspects of
Intellectual Property Rights (TRIPs Agreement).
33 Community Research and Development Information Service (CORDIS)
34 Pers comm Ir Philippe Desmeth, BCCM International Cooperation Programme Officer (15 May 2002)
35 Pers comm Dr Marie Gebhardt, BioCASE Project Administration (11 June); Community Research and Development Information Service (CORDIS) < www.cordis.lu/en/home.html>
4 EC INVOLVEMENT IN RELEVANT INTER-GOVERNMENTAL
Key fora and negotiating positions
At the intergovernmental level, the EC addresses ABS and traditional knowledge in relation to:
the work of the CBD Ad Hoc Working Groups on ABS and Article 8(j);
the negotiation and implementation of the FAO International Treaty on Plant
Genetic Resources for Food and Agriculture, based on the principle of a multilateral approach to access and benefit-sharing, consistent with IPRs, and the rights of farmers and the CBD;
relevant work in WIPO, in particular the WIPO Intergovernmental Committee on
Intellectual Property, Genetic Resources, Traditional Knowledge and Folklore; and,
other work that has or may be undertaken in the WTO, OECD, UNESCO and
Within these fora, EC negotiating positions have emphasised:
(a) Coherence and mutual supportiveness between the work of different intergovernmental fora and in their implementation (including the development of ABS strategies at the country or regional level)
Engaging a diverse array of stakeholders, including providers and users of genetic resources and traditional knowledge, is essential, particularly for indigenous and local communities It is crucial to enhance awareness of their needs and practices while ensuring their active participation in multilateral policy discussions and national implementation efforts.
(c) Coordinated and demand-driven capacity building, as a component of benefit- sharing, and for the development and implementation of ABS measures including national legislation
Facilitating access to genetic resources is crucial, achieved through transparent and easily applicable access application systems Additionally, the ongoing expansion and diversification of the crop list under the FAO International Treaty on Plant Genetic Resources for Food and Agriculture (PGRFA) will enhance global agricultural diversity and sustainability.
To enhance compliance with national Access and Benefit-Sharing (ABS) laws, it is essential to explore methods for verifying adherence to these regulations One approach is to encourage patent applicants to submit evidence of prior informed consent (PIC) and benefit-sharing agreements related to the genetic resources utilized in their inventions This practice will promote transparency and ensure responsible use of biological resources.
Intellectual Property Rights (IPRs) represent just one of the many intricate elements of Access and Benefit Sharing (ABS) The European Commission recognizes that IPRs are merely one of several tools available to genetic resource providers for securing benefits.
The development of an international framework to safeguard traditional knowledge is essential, emphasizing the importance of establishing a clear legal definition for 'traditional knowledge.' It is crucial to consider whether these rights should be recognized at the individual, collective, or common level to ensure effective protection and respect for cultural heritage.
There is a pressing need for a comprehensive analysis of how current forms of intellectual property rights (IPR) can safeguard traditional knowledge and the effects of IPRs on the traditional use of genetic resources This evaluation should encompass patents, as well as alternative protective measures such as plant variety rights and geographical indications.
(i) Ways and means of protecting traditional knowledge through its recognition as prior art
(j) Further work on limitations to IPR protection as a contribution to benefit- sharing, including research exemptions, the farmers’ privilege and compulsory licensing.
Sections 4.2 and 4.3 below explore the EC’s involvement in the negotiation of multilateral instruments such as the guidelines on ABS, and international deliberations over the links between ABS and IPRs The information presented summarises a combination of EC communications and EU position statements The text in italic is directly quoted.
Multilateral instruments and guidelines for ABS
4.2.1 CBD Bonn Guidelines on ABS
The EU supports the Bonn Guidelines on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits, as adopted under Decision VI/24 The European Commission actively participated in their development through the CBD Ad Hoc Open-Ended Working Group on ABS and prior meetings of the CBD Expert Panel In collaboration with Member States, the Commission will assess current legal, policy, and administrative frameworks to initiate the practical application of these Guidelines This summary outlines the EU's stance on implementing the Guidelines.
(i) Coherence (at multilateral and national levels)
36 Based on EU position statements at Bonn, 22 to 26 October 2001.
The EU emphasizes that the Guidelines must be implemented in a way that is consistent and mutually reinforcing, particularly in relation to the FAO International Treaty on Plant Genetic Resources for Food and Agriculture (PGRFA) and the initiatives of the WIPO Intergovernmental Committee.
The EU emphasizes that national Access and Benefit-Sharing (ABS) systems should align with a comprehensive ABS strategy tailored to each country or region This strategic approach aims to ensure that the legislative, administrative, and policy measures implemented by Parties effectively support the objectives of the Convention and are harmonized with National Biodiversity Strategies and Action Plans.
The EU emphasizes the importance of diverse stakeholders in the management of genetic resources, recognizing their dual roles as both providers and users It particularly advocates for the inclusion of indigenous and local communities, acknowledging their crucial contributions to biodiversity conservation and sustainable use The EU outlines key priorities aimed at enhancing stakeholder involvement in these efforts.
facilitate the creation of a national networks of stakeholders
link with national policy on conservation and use of genetic resources and related traditional knowledge
strengthening stakeholder capacity for the conservation, sustainable use and exchange of genetic resources and associated knowledge
The EU believes that measures developed according to the guidelines should provide for:
awareness and information on national and international legal and institutional frameworks and of stakeholder needs and practices.
Stakeholder participation is crucial in the drafting, implementation, and review of Access and Benefit-Sharing (ABS) measures Their involvement is essential during negotiations to determine the conditions under which access to genetic resources is granted.
The EU welcomes the emphasis on capacity-building at national and international levels
A demand-driven capacity-building program is essential for the effective development and implementation of Access and Benefit-Sharing (ABS) arrangements It should complement existing initiatives to avoid duplication and enhance institutional synergy, while also considering the limited human resources available in the involved Parties.
(iv) Compliance, dispute settlement and remedies
The EU supports the Bonn Guidelines, emphasizing the importance of verifying compliance through evidence of prior informed consent (PIC) and agreements on benefit-sharing Additionally, the EU values the mechanisms for dispute resolution and remedies for breaches of national laws, administrative policies, or measures related to Access and Benefit-Sharing (ABS).
4.2.2 FAO International Treaty on Plant Genetic Resources for Food and
The EU enthusiastically supports the adoption of the International Treaty on Plant Genetic Resources for Food and Agriculture (IT), marking a significant milestone as the first legally binding agreement focused on sustainable agriculture The EU and its Member States aim to sign the treaty promptly and encourage all members of the FAO Commission to follow suit.
The IT aims to promote sustainable agriculture and food security while supporting the CGIAR and its ex situ collections Additionally, it plays a crucial role in implementing the CBD through a multilateral system that facilitates access to Plant Genetic Resources for Food and Agriculture, along with benefit-sharing This system encompasses significant benefits such as information exchange, technology transfer, capacity building, and commercial benefit-sharing, creating a comprehensive support framework.
The EU asserts that the International Treaty (IT) is not subordinate to other international agreements, highlighting their mutual support and emphasizing that the preambular paragraphs of the IT should be interpreted to enhance global food security Furthermore, the European Community and its Member States interpret Article 12(3)(d) as acknowledging that plant genetic resources for food and agriculture (PGRFA), or their genetic components resulting from innovation, may be eligible for intellectual property rights (IPRs), provided the necessary criteria are fulfilled This interpretation aligns with the commitment to maintain permanent facilitated access to plant genetic resources within the multilateral system.
The European Union strongly believes in the urgent need to expand and diversify the list of crops, especially those vital for tropical and subtropical regions This expansion is essential for the Innovation Technology (IT) to effectively contribute to global food security.
The European Union is dedicated to collaborating with the Commission on Genetic Resources for Food and Agriculture, serving as the Interim Committee for the International Treaty on Plant Genetic Resources for Food and Agriculture, which will take effect upon its implementation.
37 EU position statements at Bonn, 22 to 26 October 2001 (proposal for replacement of paras 63 to 70 of the Secretariat paper) Decision VI/24, Bonn Guidelines, Section V ‘Other Provisions’ D – F.
38 European Region Statement on the adoption of the International Treaty on PGRFA.
39 European Region Statement on the adoption of the International Treaty on PGRFA.
Recipients of plant genetic resources for food and agriculture must refrain from asserting any intellectual property or other rights that could restrict access to these resources or their components, as received from the Multilateral System.
During the 31st Session of the Conference held in Rome from November 2 to 13, 2001, the European Community and its Member States presented a statement addressing the relationship between the International Treaty on Plant Genetic Resources for Food and Agriculture (PGRFA) and other international agreements This statement emphasized the importance of harmonizing the Treaty with existing international frameworks to promote sustainable agricultural practices and enhance food security across Europe.
The European Region emphasizes the importance of adopting the International Treaty on Plant Genetic Resources for Food and Agriculture (PGRFA) and calls for the swift and transparent implementation of its provisions A key priority for this implementation is the development of the standard Material Transfer Agreement outlined in Article 12.4, which facilitates the exchange of genetic resources within the Multilateral System.
Intellectual property rights and benefit-sharing
4.3.1 CBD deliberations on ABS and IPRs
On 2 February 2001, the EC and its Member States submitted views to the Executive Secretary of the CBD on Intellectual property rights, access to genetic resources and the sharing of benefits arising from their use 44 in response to Decision V/26 paragraph 15(a).
The statement does not constitute an EU position.
The EU emphasized the significant connection between Access and Benefit-Sharing (ABS) and Intellectual Property Rights (IPRs), highlighting that IPRs on final products can serve as vital incentives for generating various benefits These rights encourage private companies to invest in the innovation and development of new products and processes, fostering economic growth and technological advancement.
Intellectual Property Rights (IPRs) do not inherently serve as mechanisms for sharing the benefits derived from the use of original genetic resources Instead, monetary benefits are realized only after the commercialization of the protected material.
- IPRs and the protection of traditional knowledge;
- the scope of the protection afforded by IPRs to inventions using genetic resources; and,
- IPRs as an instrument for the implementation of the Article 15.7 of the CBD.
The EU statement to the Executive Secretary recognised that most IPR systems, in their present form, are not geared to the protection of all aspects of traditional knowledge The
- the importance of establishing a legal definition for ‘traditional knowledge’
- the need to determine whether such rights should be established at the individual, collective or common level
There is a pressing need for a comprehensive analysis of the effectiveness of existing intellectual property rights (IPRs) such as patents, plant varieties, geographical indications, copyright, industrial designs, trademarks, and the protection of confidential information This evaluation aims to determine how well these mechanisms fulfill their intended objectives of protection.
43 Statement of the Presidency on behalf of the European Community and its Member States, Item 7 – International Treaty on PGRFA, Conference 31 st Session, Rome, 2 – 13 November 2001.
The European Commission's Directorate-General for Environment addresses the significance of intellectual property rights in relation to access to genetic resources and the equitable sharing of benefits derived from their utilization, as outlined in their report from Brussels dated February 2, 2001.
45 ibid traditional knowledge, and of the possibility of establishing new ‘sui generis’ property rights.
Clarifying the impact of granting Intellectual Property Rights (IPR) to third parties is essential, as it can significantly affect local communities and indigenous populations This influence may directly or indirectly hinder their ability to maintain and practice their historical and customary traditions Understanding these implications is crucial for ensuring the protection of cultural heritage and the rights of indigenous peoples.
These concerns were subsequently addressed by CBD COP6, through:
Decision VI/24C mandates the Executive Secretary, in collaboration with WIPO and the CBD Ad Hoc Open-Ended Intersessional Working Group on 8j, to conduct additional information gathering and analysis regarding the interplay between intellectual property rights (IPRs) and customary laws and practices.
Decision VI/10 F emphasizes the need for the Ad Hoc Open-Ended Intersessional Working Group on 8j to explore sui generis systems It advocates for pilot projects and feasibility studies to assess the effectiveness of current intellectual property rights (IPR) regimes and mechanisms for protecting traditional knowledge Additionally, it urges Parties and Governments, with WIPO's support, to consider traditional knowledge in the evaluation of novelty and inventive step in patent applications.
Decisions VI/24 C and VI/20 H emphasize the importance of collaboration between WIPO and CBD parties to safeguard traditional knowledge These decisions also call on WIPO to share the outcomes of its discussions with the CBD COP, particularly concerning access to genetic resources and benefit-sharing linked to traditional knowledge.
At CBD COP6 46, the EU expressed support for advancements in the CBD Work Programme on Article 8j, aiming to enhance the protection of traditional knowledge vital for biodiversity conservation The EU emphasizes the importance of Task 12, which focuses on creating guidelines to aid Parties and Governments in legislating and implementing Article 8(j) Additionally, the EU advocates for exploring synergies between Article 8j and the CBD Bonn Guidelines, while promoting ongoing dialogue and collaboration between the CBD and other relevant organizations such as WIPO, UNCTAD, UNESCO, WTO, and FAO.
(ii) Scope of protection afforded by IPR to inventions using genetic resources
In February 2001, the EU communicated to the Executive Secretary that earlier CBD documents had highlighted various patent-related issues Additionally, the EU stressed the importance of thoroughly examining alternative protection methods, such as plant breeders’ rights and geographical indications, while proposing further research on these topics.
the impact of IPRs on the use of genetic resources employed in the development of protected inventions, particularly traditional uses of the genetic resources; as well as,
Intellectual Property Rights (IPRs) have limitations, such as research exemptions and farmers' privileges, which are important considerations in their application The European Union has acknowledged discussions within the Convention on Biological Diversity (CBD) advocating for compulsory licenses that favor provider countries and communities, as well as those aimed at promoting biodiversity conservation.
46 COP6 EU position statement on Article 8j and related provisions, 7 April 2002.
Decision VI/24C calls for a comprehensive analysis by the Executive Secretary, WIPO, and the Ad Hoc Open-Ended Intersessional Working Group on 8j regarding the impact of intellectual property rights (IPRs) on access to genetic resources and scientific research During COP6, the EU emphasized the need to explore methods for recognizing prior art as a valuable approach to identifying limitations in the issuance of patents and other IPRs, aimed at safeguarding traditional knowledge, innovations, and practices, which is currently being addressed by the WIPO working group on traditional knowledge.
(iii) IPRs as an instrument for implementation of Article 15.7 of the CBD
The EU statement to the Executive Secretary noted that CBD delegations tend to view
Filing or granting an Intellectual Property Right (IPR) for an invention utilizing genetic resources may create an economic incentive by initiating benefit-sharing arrangements This process can occur through agreements established between providers and users of genetic resources or through compliance with national laws and regulations that govern IPRs.
- a legal instrument for verifying compliance with the CBD, whereby proof of Prior
Informed consent is essential for granting Intellectual Property Rights (IPR), as failure to comply with the Mutually Agreed Terms for access may result in the cancellation of associated IPRs or lead to civil damages and criminal charges.
BEST PRACTICE ON ACCESS AND BENEFIT-SHARING IN THE EU
Institutional policies and codes of conduct
5.1.1 Initiatives by research institutions and networks
Scientific research institutions in the EU, particularly networks of ex situ collections, have led the way in developing institutional policies and Codes of Conduct on Access and Benefit-Sharing (ABS) to ensure the lawful acquisition and exchange of genetic resources These frameworks, supported by the Bonn Guidelines, aim to enhance user transparency while allowing for flexibility tailored to specific research sectors Notably, European botanic gardens, microbial culture collections, and germplasm collections have implemented various measures to strengthen these ABS arrangements.
Box 1 ABS measures by European Botanic Gardens
(1) Principles on access to genetic resources and benefit-sharing for participating institutions
In 1997, a pilot project aimed at establishing harmonized policies for botanic gardens regarding access to genetic resources and benefit-sharing was launched by the Royal Botanic Gardens, Kew, with funding from the UK Department for International Development This initiative brought together representatives from 28 botanic gardens across 21 countries, facilitated through four workshops, and included participation from Botanic Gardens Conservation International (BGCI) and the International Association of Botanic Gardens (IABG).
Botanic gardens and similar institutions are encouraged to adopt non-legally binding Principles on access to genetic resources and benefit-sharing, creating their own policies for implementation These Principles are accompanied by an Explanatory Text, which includes Common Policy Guidelines, implementation suggestions, and examples of agreements (Latorre García et al 2001) Institutions from various countries, including the UK, Cameroon, Ghana, South Africa, Brazil, China, Mexico, Germany, India, Colombia, Australia, Russia, and the USA, have already endorsed these Principles For a regularly updated list of participating institutions, visit .
(2) The Code of Conduct and Access and Benefit-Sharing System for Botanic Gardens
In late 1996, the German Ministry of Environment initiated a research and development project focused on botanic gardens and their role in supporting the Convention on Biological Diversity (CBD), based at the Bonn botanic garden This project aimed to facilitate discussions on Access and Benefit-Sharing (ABS) issues within the German-speaking network of botanic gardens, known as Verband Botanischer Gärten e.V (VBG).
Representatives from 34 botanic gardens across Austria, Germany, and German-speaking Switzerland collaborated to create a "Code of Conduct for Botanic Gardens and similar collections," which outlines guidelines for the acquisition, maintenance, and supply of living plant material This initiative has led to the establishment of an exchange circuit for botanic gardens that support the Code, promoting the non-commercial exchange of genetic resources among these institutions A comprehensive list of botanic gardens that have adopted the German Code is available on the German Network's website and is updated regularly.
The exchange-circuit, grounded in CITES practice, has been introduced internationally as an “Access & Benefit-Sharing System for Botanic Gardens.” This concept has received endorsement from the European Consortium of Botanic Gardens, representing official national botanic garden networks in the EU By establishing an international circuit, botanic gardens committed to implementing the CBD can facilitate global material exchange for non-commercial purposes, eliminating the necessity for bilateral agreements between organizations.
PlantNet serves as the national network for botanic gardens, arboreta, and documented plant collections across Britain and Ireland, aiming to enhance the role of these collections in research, conservation, and education The organization fosters networking and training among its members and is committed to the principles of the Convention on Biological Diversity (CBD) According to PlantNet's conservation policy, botanic gardens can significantly contribute to and benefit from the CBD, while also recognizing their obligations, such as obtaining government permission to access genetic resources.
PlantNet is dedicated to ensuring that plant collections are gathered, preserved, and managed in alignment with the Convention on Biological Diversity (CBD) The organization provides valuable information about the CBD to its members and actively promotes a deeper understanding of its provisions.
To achieve this, PlantNet will:
organise training courses for members on the CBD and its implementation;
provide information to bodies coordinating CBD implementation nationally and internationally;
Engage in national and international initiatives to shape policies for botanic gardens and plant-collection holders, focusing on the Convention on Biological Diversity (CBD) and emphasizing material transfer and benefit-sharing practices.
PlantNet members play a crucial role in sharing the benefits gained from plant collections, especially in biodiversity-rich countries that lack the resources needed for conservation Their efforts help promote sustainable practices and ensure that these valuable ecosystems are preserved for future generations By fostering collaboration and knowledge exchange, PlantNet contributes to the conservation of global biodiversity while supporting local communities in their environmental stewardship.
assist individual collection holders in developing their own institutional policies and practices in accordance with the CBD.
The pilot project for botanic gardens, as outlined by F Latorre García et al (2001), emphasizes the importance of principles regarding access to genetic resources and benefit-sharing The project provides common policy guidelines aimed at facilitating the implementation of these principles, ensuring that genetic resources are used sustainably while benefiting all stakeholders involved.
The Access and Benefit-Sharing System for Botanic Gardens, compiled by Driesch, Klingenstein, Lobin, and van den Wollenberg, was presented at the Sixth meeting of the CBD Conference of Parties from April 7 to 9, 2002 Additionally, insights were provided by Simon Thornton-Wood, the PlantNet Coordinator, in a personal communication dated May 24, 2002.
Box 2 ABS measures by European culture collections
(1) Micro-organisms Sustainable Use and Access Regulation International Code of
Launched in 1997 by the Belgian Co-ordinated Collections of Micro-organisms (BCCM) with support from the European Commission's Directorate General XII, the MOSAICC initiative serves as a voluntary code of conduct aimed at facilitating access to microbial genetic resources in accordance with the Convention on Biological Diversity (CBD) and relevant laws It emphasizes the importance of establishing appropriate agreements for material transfer between partners and ensuring effective monitoring for benefit-sharing As a dynamic framework, MOSAICC is open to continuous enhancement, similar to the CBD Bonn Guidelines on Access and Benefit-Sharing.
MOSAICC supports microbiologists in obtaining Prior Informed Consent (PIC) for access to genetic resources, adhering to CBD Article 15.5, and facilitates the negotiation of Material Transfer Agreements (MTAs) for the transfer of these resources, ensuring fair benefit-sharing and scientific cooperation as outlined in CBD Articles 15.4, 15.6, 15.7, 16, 18, and 19 The initiative provides guidance to countries offering microbial genetic resources by recommending procedures for issuing PIC and monitoring resource transfers to promote equitable benefit-sharing Additionally, MOSAICC offers model documents and application forms to serve as guidelines for effective implementation of the CBD All relevant resources can be downloaded from .
The Code was created through a consultative process involving 12 partners from European and Southern institutions, resulting in five drafts that incorporated feedback on its applicability and usefulness MOSAICC serves as a framework for microbial collections to establish their own institutional policies and material transfer agreements (MTAs), and is increasingly recognized as a tool to facilitate the legal transfer of materials while enhancing the negotiating power of culture collections in Access and Benefit-Sharing (ABS) agreements.
(2) CAB International (CABI) Policy on Access to Ex Situ Genetic Resources
Examples of benefit-sharing arrangements
This section presents various benefit-sharing arrangements related to the collection and utilization of genetic resources and traditional knowledge by research institutions and companies within the EU, encompassing both commercial and non-commercial agreements.
5.2.1 Non-commercial benefit-sharing arrangements
Research institutions and ex situ collections in the EU engage in a variety of non-commercial Access and Benefit-Sharing (ABS) arrangements with global partners These arrangements can take the form of informal memoranda of understanding or legally binding agreements with providers of genetic resources and traditional knowledge The benefits derived from these collaborations include training, technology transfer, joint research initiatives, and capacity building for both in situ and ex situ conservation efforts Notably, the Royal Botanic Gardens, Kew, exemplifies successful collaborative research and benefit-sharing through diverse activities.
Box 6 ABS agreements for non-commercial research
The Millennium Seed Bank at the Royal Botanic Gardens, Kew, UK, establishes full Access and Benefit-Sharing Agreements (ABSAs) with source country governments for field collections of live and herbarium specimens, collaborating with local partner institutions These legally binding ABSAs, signed by relevant government agencies and project partners, outline specific terms for benefit-sharing, including bilateral research, training, and capacity-building Additionally, RBG Kew has created non-legally binding Memoranda of Understanding (MoUs) with key partners, which define general collaboration terms primarily for taxonomic research involving herbarium specimens, rather than living materials Both ABSAs and MoUs align with the Principles on access to genetic resources and benefit-sharing for participating institutions.
Research institutions and ex situ collections often establish agreements for collaborative purposes For instance, the Netherlands Centre for Genetic Resources (CGN) has a Memorandum of Understanding (MoU) with the Rokupr Rice Research Station in Sierra Leone to maintain a backup collection of rice accessions Additionally, CGN partners with SEARICE in the Philippines and Can Tho University in Vietnam for the molecular analysis of farmers' rice varieties, ensuring that the agreements include prior informed consent (PIC) from local communities Furthermore, CGN has also signed Material Acquisition Agreements with government officials in Uzbekistan and Kyrgyzstan to support an international multi-crop collecting mission.
Sources: (i) CBD Implementation Unit, Conventions and Policy Section, RBG Kew; and (ii) pers comm Bert Visser, Centre for Genetic Resources the Netherlands (20 February and 6 May 2002).
Box 7 Examples of collaborative research and benefit-sharing by the Royal Botanic Gardens, Kew
COUNTRY/Initiative Partners Dates Project description Collaborative research and benefit-sharing
A diverse array of public and semi-autonomous seed banks, botanical institutions, and universities operates with the support of prior informed consent from national governments across 12 countries, including Australia, Burkina Faso, Chile, Egypt, Jordan, Kenya, Lebanon, Madagascar, Mexico, Namibia, South Africa, and the USA.
2000- Aims to collect and conserve 10% of the world’s seed- bearing flora (principally from drylands) by 2010 Works by means of bilateral research, training and capacity- building relationships world-wide.
We assist partners in fulfilling their CBD obligations by addressing national priorities outlined in National Biodiversity Strategy Action Plans (NBSAPs) and enhancing in-country capacity through collaborative collecting programs Our extensive seed conservation services for international partners include long-term secure storage of seeds, access to MSB research laboratories for collaborative seed conservation research, and complementary facilities at RBG Kew, such as the Herbarium, library, and SEPASAL database We facilitate coordinated data exchange within one-country projects, providing partners with preferred access to results from broader strategic research and conservation efforts Additionally, we offer formal courses in seed conservation techniques as part of the International Diploma in Plant Conservation Techniques, along with postgraduate training opportunities at MSc, MPhil, and PhD levels, and focused in-country workshops.
Associaỗóo Plantas do Nordeste, a consortium of research and teaching institutes in NE Brazil, University of São Paulo, Brazilian and UK governments
In 1992, a multidisciplinary research program was initiated to enhance the identification and sustainable utilization of plant resources in Northeast Brazil This initiative aims to generate, mobilize, and update high-quality information on various plant species, including their uses, distributions, and ecological characteristics Such information is essential for implementing effective biodiversity conservation strategies and promoting sustainable development in the region.
RBG Kew is actively involved in various initiatives, including an information dissemination and training project that focuses on repatriating data from its databases Additionally, it has established a herbarium specimen data and image repatriation scheme Collaborative field surveys and conservation monitoring are also key components of their work, alongside the production of Floras, florulas, checklists, and online databases Furthermore, RBG Kew is developing a sustainable fuelwood utilization project and surveying forage grasses, while also supervising PhD research and participating in postgraduate training programs.
NGOs including Bamenda Highlands Forest Project;
In 1996, a comprehensive survey of the flora of Western Cameroon was initiated to gather essential data for conservation organizations and resource planners This initiative aimed to bolster the National Herbarium of Cameroon, enhancing its role as a vital center for assessing plant biodiversity and conducting taxonomic research.
Joint collecting expeditions and the creation of conservation checklists, including red data assessments, are essential for biodiversity preservation Additionally, developing species and specimen databases, along with training workshops on plant identification and inventory techniques, enhances conservation efforts The Kew diploma course on Herbarium Techniques, offered at the National Herbarium, plays a crucial role in this training Furthermore, repatriating data and images of historical Cameroon specimens from RBG Kew to the National Herbarium supports the documentation and study of plant species in Indonesia.
The initiative seeks to restore and expand the Herbarium at Manokwari while enhancing self-sufficiency by training a dedicated group of skilled botanists This effort aims to develop and maintain plant collections, strengthen research and conservation of plant diversity, and foster collaborative partnerships with relevant institutions, including those in Papua New Guinea.
The renovation of the herbarium, acquisition of new materials, and establishment of a comprehensive collections database at RBG Kew have been pivotal in enhancing specimen naming and facilitating data repatriation by the UK project coordinator This initiative has fostered study visits between RBG Kew, Manokwari, and Papua New Guinea, alongside participation in international meetings and publications in peer-reviewed journals These efforts have led to the development of both independent and collaborative research focused on Papuan plant diversity Additionally, university lectures, field trips, workshops, and the Kew diploma course in Herbarium Techniques in Papua have contributed to the production of valuable field guides for palms and seed plant families.
Protocol covering all current projects
Ministry of Higher Education; L’Association Nationale pour La Gestion des Aires Protégées; FJKM/SAF;
Ministère de la Recherche Scientifique; Projet d’Appui aux Exportations Agriccoles de la Coopération Franỗaise; Projet Masoala; Recherches Forestiốres et Piscicoles, Antananarivo (TEF); WWF Madagascar;
Silo National des Graines Forestières (SNGF) ; USA Missouri Botanical Garden ; France Muséum National d'Histoire Naturelle Paris ; Belgium The National Botanical Gardens of Belgium
Current taxonomic research in Madagascar focuses on systematically revising five major plant groups that exhibit high species diversity, while also enhancing the systematic research capabilities of local partners.
The Threatened Plants Appeal project is dedicated to the conservation of highly endangered species, particularly focusing on palms, orchids, and succulents This initiative collaborates with various Malagasy partner institutions to enhance conservation efforts and promote sustainable use of these vital plant species.
Outputs include joint fieldwork, training in species inventory skills, collaborative production of checklists, identification keys and generic accounts with conservation ratings; and intensive training of PhD and MSc students
Joint field surveys and monitoring enhance the development of national and local collections, strengthening capacity for both in situ and ex situ conservation Collaborative efforts focus on creating cultivation protocols, providing training on the ecological needs of native species, and promoting practical conservation and horticulture practices.