Apart from finding appropriate ways of regulating these three pillars of ABS, the international community has faced a number of other challenges in order to effectively and efficiently operationalize ABS. These include the following issues amongst others.
Implementation in a wide variety of national contexts
Since the entry into force of the CBD, only a limited number of States, mainly biodiversity-rich countries, have adopted comprehensive ABS regimes at the national level.6 Many countries, however, still do not provide for any specific ABS laws, regulations or administrative processes.
Countries that developed domestic ABS frameworks have chosen different ways in which to implement the ABS provisions of the CBD at the national level. For example, different ways of understanding biological resources, genetic resources, derivatives, and products exist, which has led to a variety of definitions of scope in ABS legislation. Countries may choose to extend the scope of their ABS regime beyond that of the CBD to cover not only genetic but also biological resources, or they can interpret the scope more narrowly. Furthermore, countries may take a very restrictive approach when regulating access to their genetic resources, or they may provide for free access. Also, each country has its own legal system, national authorities, and stakeholders. ABS procedures will therefore differ from provider country to provider country, with sometimes long, confusing, cumbersome processes requiring permits from several regional and local agencies that administer the same resource.
Consequently, there is a wide variation in the implementation of ABS at the national and sub-national level, which can lead to confusion for both providers and users of genetic resources and/or traditional knowledge associated with such resources.
Institutional arrangements and lack of capacity
Practical experience of the implementation of ABS has further shown that in addition to an appropriate legislative framework, an enabling institutional framework is required. However, many countries face similar difficulties in setting up efficient and effective institutional arrangements that support the operationalization of ABS. One underlying problem seems to be the competition between existing institutions and entities regarding the authority to grant access, and even more so to receive potential benefits. Unclear, overlapping, or simply non-existent institutional competencies have also been highlighted as challenges to implementing ABS effectively.
6 A database including ABS measures undertaken by the CBD Contracting Parties can be found at
Another difficulty relates to the lack of capacity on all sides to deal with the complexities of ABS.
ABS implementation involves technical expertise regarding negotiation of ABS agreements, intellectual property rights, biodiversity conservation, business, commerce, economics, biotechnology, national and international law, social and cultural issues, and other issues. Such interdisciplinary expertise has been limited if not absent in many countries (Carrizosa et al., 2004, p. 300).
The resulting legal uncertainties, administrative deficiencies and delays, and high transaction costs may lead to considerable frustration among ABS stakeholders.
Ex-situ collections
Finding an appropriate and fair approach in view of ex-situ collections has been another critical stumbling block in the implementation of ABS. Ex-situ conservation is defined by Article 2 of the CBD as “the conservation of components of biological diversity outside of their natural habitats”. Ex-situ collections take the form of collections of genetic resources held in gene banks (seed and in the field), zoos, arboreta, botanical gardens, in vitro storage, pollen storage, and DNA storage, to name a few examples (Maxted et al., 1997). Seed gene banks are the most common storage practice (FAO, 1998, p. 510).
Article 9 of the CBD further clarifies:
the use of ex-situ conservation method to support in-situ measures;
ex-situ collections should be kept and researched preferably in the country of origin; and
those collections should be used for measures for recovery and rehabilitation of threatened species for reintroduction into natural habitats, under appropriate conditions.
Research on ex-situ collections can take a wide variety of forms and purposes. Most research is of a non-commercial nature, to improve understanding of genetic diversity and how to best conserve it. There are also examples of applied commercial research on collections, resulting in a commercial product of various forms (see Laird and Wynberg, 2008). Botanical gardens, in particular, have played an important role in medical and taxonomic research, the distribution of useful plants and their genetic resources worldwide, and the conservation of biological diversity (Davis, 2008, p. 6).
Many if not most of the genetic resources collected ex-situ were accessed before the entry into force of the CBD, and a large amount of the stored resources historically came from biodiversity-rich developing countries. Regardless of pre- or post-CBD acquisition, developing countries have had high expectations of benefiting from new utilizations of the collected genetic resources. For a combination of ethical and pragmatic reasons, some botanical gardens and herbaria treat all of their collection as falling under the obligations of the CBD. However, in practice the unknown geographical origin of some genetic resources may hamper appropriate benefit-sharing in practice.
Traditional knowledge within CBD and other international fora
As explained earlier, the link between traditional knowledge associated with genetic resources and ABS is based on Article 8(j) of the CBD. However, the implementation of ABS in relation to traditional knowledge associated with genetic resources is a challenge for several reasons.
First of all, Article 8(j) of the CBD does not define the term “traditional knowledge”. In fact, it only provides an indication of how the concept of traditional knowledge must be understood in the CBD framework, namely as such “knowledge, innovations and practices” that “embody traditional lifestyles relevant for the conservation and sustainable use of biological diversity”. It is developed from experience gained
over centuries and adapted to the local culture and environment, transmitted orally from generation to generation, and collectively owned, and it takes the form of stories, songs, folklore, proverbs, cultural values, beliefs, rituals, community laws, local language, and agricultural practices. Such a broad understanding can sometimes make it difficult to capture what qualifies as traditional knowledge. This again may lead to confusion on both the provider and user sides, as well as to complications for regulation through legal instruments, such as intellectual property rights.
Particular legal and practical problems may arise in cases when ownership of such knowledge is not definable – that is, the holder of the knowledge is unknown or not identifiable – or when such knowledge leaves a community without PIC of the relevant ILC group and enters the “public domain”, which means that it is not protected by an intellectual property right and therefore can be appropriated by anyone without liability for infringement.
Traditional knowledge can be dispersed outside of the control of the original ILC in a number of ways, such as:
when the knowledge about a potential utilization of a genetic resource has spread to people living in the same area as the ILC in question and is since used by non-members of the ILC for that specific purpose; or
when a scientist, visiting the ILC holding the traditional knowledge, finds out about said knowledge and afterwards publishes an article on the research findings.
ABS related to traditional knowledge associated with genetic resources is linked to ongoing discussions on intellectual property rights–related aspects, particularly in the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore of the World Intellectual Property Organization (see section E). This Committee is working on an international legal instrument or instruments that would ensure the effective protection of genetic resources, traditional knowledge, and traditional cultural expressions.
It is also important to underline that the issue of traditional knowledge associated with genetic resources is closely linked to discussions on the general rights of ILCs at the international as well as national level. At the international level, the United Nations Declaration on the Rights of Indigenous Peoples (adopted in 2007)7 and the International Labour Organization Convention No. 169 on Indigenous and Tribal Peoples (adopted in 1989, entry into force in 1991)8 are important legal instruments of varying legal strength that aim to protect ILCs’ rights and thus should be taken into account in the context of ABS related to traditional knowledge.
Furthermore, local and national structures are needed, which:
involve ILCs in the development and implementation of ABS policies at the domestic level;
recognize the rights of ILCs in domestic legal systems, in particular property rights as well as self-determination and indigenous governance procedures, which will also enable effective protection vis-à-vis foreign jurisdictions;
clearly identify the knowledge holder(s) and owners of genetic resources; and
define and establish local competent authorities in cases where they do not exist and determine community-level procedures for ABS.
7 For further information, see the UN Permanent Forum on Indigenous Issues, at www.un.org/esa/socdev/unpfii/index.html.
Without such a structure in place, a three-party relationship between ILCs, their “home” countries, and users might be created that lacks sufficient transparency, clarity, and efficiency. Such a situation could in the end hamper the effective implementation of ABS related to traditional knowledge associated with genetic resources in practice.
Varying conditions for commercial and non-commercial research
Another challenge in the implementation of ABS relates to the differentiation between non-commercial and commercial research, as both are characterized by the intent of the research undertaken and not the form. Non-commercial research can be understood as non-profit research to generate new scientific insights on multiple levels, from genetic composition of biological resources to related functions. It is one of the fundamental preconditions for the conservation and sustainable use of biological diversity and the appreciation of the value of the diversity of genetic resources. Furthermore, countries that provide access to their biodiversity for non-commercial research may derive a range of non-monetary benefits, including training or a better understanding of their genetic resources. As a consequence, it makes sense for national access modalities in provider countries to treat non-commercial (non-profit) and commercial research differently.
However, both research types can use the same methods and facilities and be pursued by the same researchers. As a consequence, non-commercial research can be connected with commercial research and may lead to applied research, product development, or further uses of genetic resources.
Nevertheless, in many research activities this is not the case. Still, provider countries may be reluctant to differentiate between non-commercial and commercial research based on the following practical concerns:
changes of intent from non-commercial to commercial research;
use of sample materials by third parties in ways that were not approved by a provider country in legal agreements; and
commercial use of research results in the public domain without sharing benefits with the provider country.
Consequently, provider countries are faced with the challenge of recognizing the particular needs of non-commercial research while defining tangible indicators that separate non-commercial from commercial research (e.g., restrictions on dissemination of research results, restrictions on access to reference specimens, and patent applications).
Transboundary situations
The implementation of ABS could become a challenge in transboundary situations. It has to be recalled that genetic resources, as well as traditional knowledge associated with them, are often not endemic to a specific country or held by only one ILC. Indeed, genetic resources are often found in more than one country or even in more than one geographical region; the same traditional knowledge is often held by different ILCs, which might even be located in different countries. In such situations, a bilateral ABS approach may appear to some to be unjust, as it gives a single provider State/ILC the right to receive all of the benefits. Furthermore, the bilateral ABS approach might be considered problematical to address such transboundary situations, as it can lead to competition between the different provider States/ILCs sharing the same genetic resources/traditional knowledge associated with those resources, which will weaken their position in the negotiation of MAT and might lead to a “race to the bottom” regarding ABS
requirements. Therefore, it is sometimes argued that a multilateral benefit-sharing approach could be more appropriate and fair to tackle such transboundary situations.
However, it is important to recall that Article 15 of the CBD clearly envisages applying a bilateral instead of a multilateral ABS approach. Furthermore, it must be noted that polymorphism means the economic value may lie in the internal genetic differences between examples of the same species (local adaptations, for example). Moreover, countries that put ABS systems in place may feel aggrieved if other countries effectively ”free ride” and obtain a share in benefits derived on the basis that they happen to have the same species occurring in-situ.
C. The Road to Nagoya and Beyond
The challenges just described illustrate the need for specific guidelines and instruments in order to facilitate implementation of ABS in practice. More than 18 years passed between the adoption of the CBD in May 1992 and the adoption of the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity (Nagoya Protocol) in October 2010 in Nagoya, Japan. During this time the CBD Contracting Parties studied, discussed, elaborated, and further negotiated the ABS concept. The way to Nagoya was a long road, with four different phases and important stepping stones to be recognized.9
Phase 1: ABS Developments Prior to the Negotiation of an International Regime
The issue of ABS was addressed by the CBD Conference of the Parties (COP) from the beginning. The first COP (1994, Nassau, Bahamas) listed ABS in agenda item 6.6 of the medium-term programme of work of the Conference of the Parties.10 In subsequent years, CBD COP 2 (1995, Jakarta, Indonesia) and CBD COP 3 (1996, Buenos Aires, Argentina) requested, considered, and analyzed compilations of national, regional, and sectoral legislative, administrative, and policy measures as well as participatory processes and guidelines for activities covered by Article 15, including information on the interpretation of ABS key terms, case studies, and experiences with implementation.11
ABS developments accelerated after CBD COP 4 (1998, Bratislava, Slovakia), when a regionally balanced expert panel on ABS was set up and formally initiated the work on ABS under the Convention.12 Bringing together representatives of the private and public sector as well as ILC representatives, the expert panel met on two occasions (1999 in San José, Costa Rica, and 2001 in Montreal, Canada) and developed a set of recommendations, including ones on PIC and MAT, approaches for stakeholder involvement, and options to address ABS within the CBD framework.
CBD COP 5 (2000, Nairobi, Kenya) further formalized the ongoing ABS process by establishing the Ad Hoc Open-ended Working Group on ABS (AHWG) with a mandate to develop for submission to the COP guidelines and other approaches on PIC and MAT, the participation of stakeholders, benefit-sharing mechanisms, aspects of ex-situ and in-situ conservation and sustainable use, and the preservation
9 For more detailed information on the ABS history, see the CBD website at www.cbd.int/abs/
background/#timeline.
10 See CBD COP 1 decision I/9, Medium-term programme of work of the Conference of the Parties.
11 See CBD COP 2 decision II/11, Access to genetic resources, and COP 3 decision III/15, Access to genetic resources.
of traditional knowledge.13 At its first meeting (2001 in Bonn, Germany), the AHWG prepared the draft Bonn Guidelines on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising out of their Utilization (Bonn Guidelines) (SCBD, 2002), which were later adopted with some changes at CBD COP 6 (2002, The Hague, Netherlands).14 The Bonn Guidelines were intended to provide guidance by, amongst other aspects:
identifying steps in the ABS process, with an emphasis on the obligation for users to seek PIC from providers;
identifying the basic requirements for MAT;
defining the main roles and responsibilities of users and providers and stressing the importance of the involvement of all stakeholders;
covering other elements such as incentives, accountability, means for verification, and dispute settlement; and
suggesting elements for inclusion in material transfer agreements and providing an indicative list of both monetary and non-monetary benefits.
While this was an important first step, the Bonn Guidelines could not be seen as a final decision or sufficient guidance. Indeed, they were planned to be “evolutionary” in nature, meaning that they were intended to provide starting points for national framework development processes and national negotiations that had to be reviewed, accordingly revised, and improved as ABS experience was gained. Furthermore, the Guidelines were relatively contentious, with some Contracting Parties and ABS stakeholders criticizing them as being incomplete, only voluntary, focusing too much on the user side, and not taking enough into account the critical concerns of providers (e.g., compliance with and enforcement of national ABS regimes), as well as conservation and sustainable use issues.
Others considered the Bonn Guidelines as too specific and detailed. Nevertheless, they presented best practices for providers and their implementation in domestic ABS laws provided valuable experiences that were fed into the negotiations leading to the Nagoya Protocol.
Phase 2: The Mandate to Negotiate an International Regime on ABS
At the United Nations World Summit on Sustainable Development (WSSD) in 2002 in Johannesburg, South Africa, the “Johannesburg Plan of Implementation” that was adopted included different references to ABS. Amongst others, the international community called for action to negotiate an international regime to promote and safeguard the fair and equitable sharing of benefits arising out of the utilization of genetic resources15 within the framework of the CBD, taking the Bonn Guidelines into account.
CBD COP 7 (2004, Kuala Lumpur, Malaysia) followed this call and mandated the AHWG “with the collaboration of the Ad Hoc Open-ended Inter-Sessional Working Group on Article 8(j) and Related Provisions, ensuring the participation of indigenous and local communities, non-governmental organizations, industry and scientific and academic institutions, as well as intergovernmental organizations, to elaborate and negotiate an international regime on access to genetic resources and benefit-sharing with the aim of adopting an instrument/instruments to effectively implement the provisions in Article 15 and Article 8(j) of the Convention and the three objectives of the Convention”.16
13 See CBD COP 5 decision V/26, Access to genetic resources.
14 See CBD COP 6 decision VI/24, Access and benefit-sharing as related to genetic resources.
15 Plan of Implementation of the World Summit on Sustainable Development, Chapter IV, Paragraph 44 (o).
16 See CBD COP 7 decision VII/19, Access and benefit-sharing as related to genetic resources (Article 15), D. 1.
In doing so, COP 7 interpreted the WSSD call for action in the CBD context and broadened the mandate of the AHWG to focus not only on benefit-sharing but also on the issue of access. Furthermore, CBD COP 7 adopted the terms of reference of the AHWG for the negotiation of the international regime,17 which had been discussed at the second AHWG meeting (2003, Montreal).