Explanation of the Nagoya Protocol on Access and Benefit Sharing and its implication for microbiology.

Biological control is one of the most environmentally safe and economically profitable pest management methods. Beneficial organisms used in biocontrol can be of native or exotic origin. As invasive species are being accidentally introduced at an ever-increasing rate, deliberate introductions of non-native biocontrol agents are often needed for the area-wide management of these invasive pests. However, recent regulations have delayed or prevented prospecting for new, non-native natural enemies. A first phase of regulation started in the 1980s and concerned the development of risk analyses for non-native species. At this time, as commercial biocontrol became popular and the number of species of biocontrol agents on the market quickly increased, many thought that risk analyses were needed to prevent non-experts importing and commercializing insufficiently studied organisms. However, implementation of (environmental) risk assessments for biocontrol agents has resulted in a slowdown in the use of new non-native natural enemies, and in higher project costs caused by the need to prepare elaborate application dossiers. These regulations were mainly aimed at preventing potential negative effects of releasing non-native biocontrol agents and, thus, in increasing confidence in this pest management method. The second phase of regulations started more recently and deals with the question “Who owns biological control agents?” At the Convention on Biological Diversity (CBD) in Rio de Janeiro (Brazil) in 1993, one of the three objectives formulated was “the fair and equitable sharing of the benefits arising out of the utilization of genetic resources”. Biocontrol agents are such genetic resources. The Nagoya Protocol, a supplementary agreement to the CBD, provides a framework for the effective implementation of the fair and equitable sharing of benefits (i.e. the Access and Benefit Sharing (ABS) regulations) arising out of the utilization of genetic resources. Signatories of the Protocol are required to develop a legal framework to ensure access to genetic resources, benefit-sharing and compliance. Recent applications of CBD principles have already created barriers to collection and export of natural enemies for biocontrol research in several countries. If the Nagoya Protocol is widely applied, it may seriously interfere with searching for and application of biocontrol agents against invasive pests. Therefore, the International Organization for Biological Control (IOBC) first of all made an appeal to those involved in developing the legal framework for ABS, to design regulations that support the biocontrol sector by facilitating the exchange of biocontrol agents, including clear guidelines. Secondly, the IOBC also strongly recommended that biocontrol agents should be considered as a special case under the CBD, by creating a non-financial ABS regime, mainly because classical biocontrol is a non-for-profit activity, and both developing and developed countries benefit from the use of the same biocontrol agents. Thirdly, as prospecting for new non-native natural enemies has currently been suspended if not terminated 656in many countries due to CBD and ABS procedures, the IOBC prepared a best practices guide to assist the biocontrol community to demonstrate due diligence in complying with ABS requirements. The best practices guide includes a draft ABS Agreement for collection and study of biocontrol agents that can be used for scientific research and non-commercial release into nature by countries having signed the Nagoya Protocol. If many countries decide to implement the IOBC proposal for an agreement for collection and study of natural enemies, biocontrol might face a bright future.

Access to biodiversity for food production: Reconciling open access digital sequence information with access and benefit sharing

Oberthür, Sebastian, and G. Kristin Rosendal, eds. 2014. Global Governance of Genetic Resources: Access and Benefit Sharing after the Nagoya Protocol. New York and London: Routledge.

Use and exchange of aquatic genetic resources in aquaculture: information relevant to access and benefit sharing

Access and benefit sharing (ABS) is a framework which refers to a relatively recent type of legal requirements for access to and use of “genetic resources”. They are based on diverse national and regional laws and regulations, which mostly result from the implementation of the United Nations’ Convention on Biological Diversity (CBD) and its supplementary agreement, the Nagoya Protocol. Their ambition is to achieve fair and equitable sharing of benefits arising out of the use of genetic resources as an incentive to conserve and sustainably use them. This paper describes the experiences, practical constraints and complexities encountered by users of genetic resources when dealing with ABS legislation, with a focus on users from the private sector. We provide insights on how ABS laws have fundamentally changed the way of working with genetic resources, in the hope that it inspires re-thinking of the ABS framework, to better support the overall objectives of the CBD.

The Convention on Biological Diversity (CBD), adopted in 1992 and entered into force at the end of 1993, established a global regime on access to genetic resources (GR) and sharing of benefits arising from their utilization (Access and Benefit Sharing (ABS) regime). Its protocol—the Nagoya Protocol (NP)—which entered into force 21 years later in 2014, clears up some terminological ambiguities of the Convention, clarifies and develops several procedural and instrumental elements of the regime, and obliges States Parties to implement some of its provisions, including the core instrument of the regime: the bilateral ABS agreement between users and providers of GR, that became a condition for obtaining access to the resource. However, scholars who analyzed the ABS regime as well as its official bodies find, and sometimes deplore, the small number of ABS agreements concluded so far, under the CBD as under the NP. This paper has two objectives: First, to assess the effectiveness of the ABS regime implemented by the CBD and the NP on the basis of its central instrument: the ABS agreements concluded between users and providers of GR. The aim is to accurately document the number of ABS agreements concluded since the entry into force of the regime. To our knowledge, such a counting that is neither piecemeal nor has an estimate yet been produced. To do so, I combine several sources, including first hand data collected from the official information agencies—the National Focal Points (NFP)—of each of the States Parties to the NP. Second, I provide a critical summary of the existing explanations of the low number of ABS agreements concluded and I evaluate the corresponding causal mechanisms, relying on the results I obtained regarding the number of permits and agreements.

Under the Convention on Biological Diversity (CBD) countries have sovereign rights over their genetic resources. Agreements governing the access to these resources and the sharing of the benefits arising from their use need to be established between involved parties [i.e. Access and Benefit Sharing (ABS)]. This also applies to species collected for potential use in biological control. Recent applications of CBD principles have already made it difficult or impossible to collect and export natural enemies for biological control research in several countries. If such an approach is widely applied it would impede this very successful and environmentally safe pest management method based on the use of biological diversity. The CBD is required to agree a comprehensive Access and Benefit Sharing process in 2010, in preparation for which the IOBC (International Organization for Biological Control of Noxious Animals and Plants) Global Commission on Biological Control and Access and Benefit Sharing has prepared this position paper. Here, we first describe the practice of biological control in relation to the principles of ABS, illustrated extensively by case studies and successes obtained with biological control. Next, we emphasise the very limited monetary benefits generated in biological control when compared to other fields of ABS such as the collection of germplasm for development of human drugs, chemical pesticides or crop cultivars. Subsequently, we inform the biological control community of good ABS practice and challenges, and we hope to make clear to the community involved in ABS under the CBD the special situation with regard to biological control. Finally, based on the non-commercial academic research model, we make recommendations which would facilitate the practice of collection and exchange of biological control agents, propose a workable framework to assist policy makers and biological control practitioners, and urge biological control leaders in each country to get involved in the discussions with their national ABS contact point to take their needs into consideration.

ABSTRACTBiological control agents must be collected and utilised in compliance with the Nagoya Protocol on Access and Benefit Sharing (ABS) which is being implemented independently by each country that is signatory to the Protocol. By March 2018, 50 countries had legislation in place with an additional 54 designing their Legislative, Administrative or Policy Measures having become Party to the Protocol. Apart from the problem of dealing with the many different mechanisms countries are putting in place, it is often difficult to find relevant information on the ABS Clearing House and to access and receive appropriate responses from the National Focal Points or Competent National Authorities. We feel that a lot of time is lost on both sides (National authorities and scientists seeking information), and the process would benefit from streamlining. Also, open questions remain, such as how to deal with the generation digital sequence information and what specific activities are considered utilisation, especially for biological control. CABI has pro-actively developed an ABS policy and best practices for its staff to try and comply with the Nagoya Protocol. In addition, CABI has started negotiations with several provider countries, beginning with its member countries, to have its ABS policy and best practices recognised, considering the non-monetary benefits typically associated with biological control. The Nagoya Protocol was born out of the necessity to guarantee the fair and equitable sharing of benefits arising from the utilisation of genetic resources. However, it should not hinder the development of best practice solutions to protect exactly these genetic resources from threats like invasive species. It is important that research and development that addresses global societal challenges are not impeded and that science and its output are recognised as a way to preserve and use genetic resources in an equitable way.

In 1995 and 2017 respectively, Cameroon ratified the Convention on Biological Diversity (CBD) and its Nagoya Protocol (NP) on Access and Benefit Sharing (ABS). Cameroon’s ratification of the NP on ABS indicates the country’s commitment to translate and operationalize its provisions in a domestic ABS regulatory framework. A process was initiated in 2013 by the Government of Cameroon (GoC) that was aimed at: (1) Adopting a ministerial order on ABS that would govern ABS negotiations on the specific case of Echinops giganteus and other emerging cases and; (2) Constructing a comprehensive NP compliant ABS policy, administrative and legal framework. This chapter looks at the progress so far in Cameroon in establishing a NP compliant ABS regulatory framework. It also discusses the newly adopted ABS law of July 2021 and the draft implementing regulations around the following issues: the scope of the regulatory framework and the proposed institutional framework; the nature of the key regulatory tools such as the prior informed consent (PIC), mutually agreed terms (MAT/ABS contracts) and benefit-sharing schemes; the approach taken by the emerging instruments to address the different facets and levels of compliance. Likewise, it discusses the extent to which the ABS instruments are compliant with the NP, highlights their strengths and weaknesses and suggests way forward in view of delivering an effective and NP compliant ABS regime.KeywordsCameroonAccess and benefit-sharingNagoya protocolRegulatory frameworkABS compliance

Transparency as well as complete and traceable documentation of specimens, samples and associated information are prerequisites to comply with laws and regulations in Provider and User Countries to ensure benefits of utilised genetic resources are shared. Besides legal compliance, these measures should also help to build trust among users, suppliers and collaborators. This concerns for example laws of providing countries that have established access laws under the Nagoya Protocol, such as Mexico's Ley General de la Vida Silvestre, or under the Convention of Biological Diversity (CBD), such as the Brazil Law No. 13,123, regulating access to the country's genetic heritage. On the other hand there are laws and regulations in user countries that ensure compliance with access laws of providing countries under the Nagoya protocol (e. g. Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16. April 2014, which has to be implemented at national level in the EU member states). As an institution holding genetic resources as living collections (including seeds), herbarium specimens and DNA and tissue samples as well as a wealth of associated data, the Botanic Garden and Botanical Museum Berlin (BGBM) aims at creating transparency on the processes associated with the handling of these materials and data, such as metadata or associated analytical research results (Fig. 1). As a member of CETAF (Consortium of European Taxonomic Facilities), IPEN (International Plant Exchange Network), and GGBN (Global Genome Biodiversity Network) the workflows and documentation of biological collections at BGBM are in compliance with CETAF’s Code of Conduct on Access and Benefit Sharing (https://www.cetaf.org/services/natural-science-collections-and-access-and-benefit-sharing) for herbarium specimens including algae, IPEN´s Code of Conduct (http://www.bgci.org/policy/ipen) for living plants and seeds, and GGBN’s (https://library.ggbn.org/share/s/UM5JietQR9aevtYDymHbjw) code of conduct (CoC) for DNA and tissue samples. A major challenge was to ensure the comprehensive, transparent, and traceable documentation of specimens and associated material and information along our internal workflows that have evolved with the development of a manifold of protocols. However, this challenge presented the opportunity to revise the existing protocols that cover the handling, collecting, and processing of the specimens, which had accumulated over the long history of our collections and our databases, into a consistent set of workflows (Stevens et al. 2019). A key component is the Collection Data Form (CDF) which guarantees that all necessary documentation will be imported into our collection management systems, including potential restriction of destructive sampling or loaning. The latest version of the CDF as wells as other information about BGBM’s collection and data workflows can be found at https://wiki.bgbm.org/collectionworkflows. This site has been created in late 2018 to be used by everyone to explore BGBM’s routines and examples. All legal and formal documents, such as collecting permits, Prior Informed Consent (PIC), CITES documentation, phytosanitary documents, Material Transfer Agreement (MTA), long term agreements with partner institutions, project agreements etc., are digitized and managed using a digital asset management software (Alfresco, an open source document management system, www.alfresco.com. The challenge is to link all this information unambiguously. To achieve this, all of BGBM’s collections (tissue and DNA-samples as well as living plants, seeds and diatom cultures) must have, whenever possible, a herbarium specimen that can be permanently stored and that allows a correct taxonomic identification of the material. These voucher specimens shall be digitized. Therefore, all data and all documentation can be traced back to identifiers referring to a herbarium specimen or living accession. The other collections (e. g. DNA and tissue samples) also get unique identifiers that are cross-referenced with each other. By this process we ensure that genetic material is identified by collecting number (assigned by the collector), as well as accession number and barcodes (assigned by BGBM according to type of material such as plant tissue, DNA, sample, seed lot, plant accession number of living plants, environmental sample, culture strain or herbarium specimen), and, most importantly in this regard, the document number/identifier of the legal or formal documents issued by the national legal entity or signed by a partner institution (assigned by the documentation office at BGBM when digitized). All these identifiers or numbers must refer to the respective material and as such allow BGBM to trace back the material at all stages of processing. This is of vital importance when genetic material is exchanged with partners. If there are any restrictions or any requirements for the further processing, use or exchange of plant material this is documented and flagged in all database modules and accession numbers.

The Convention on Biological Diversity (CBD) and its Nagoya Protocol (NP) established an Access and Benefit Sharing (ABS) system between utilizers and providers of genetic resources. ABS is understood as a tool that should promote commutative justice between the involved parties. This essay discusses what exactly it is that is being exchanged in the ABS process. It critically analyses moral claims to compensation that are implied by the ABS system for genetic resources. It argues that with the exception of cases in which traditional knowledge is involved, states are not automatically entitled to compensation in return for the utilization of genetic resources growing within their territory. However, biodiversity-rich states that make an effort to protect biodiversity must be compensated for complying with the requests set out in the CBD. Although it acknowledges that the NP is a step towards recognizing this claim, this essay argues that ABS is not the appropriate method to compensate for biodiversity conservation.

Biodiversity COP15 - A stepping stone towards effective access and benefit sharing Here, Dominic Muyldermans and Markus Wyss explore the opportunities and challenges on the journey towards effective access and benefit sharing across the globe. The objectives of the Convention on Biological Diversity (CBD) of 1992 are the conservation and sustainable use of biodiversity, as well as the fair and equitable sharing of benefits arising out of the utilization of genetic resources. The CBD recognizes that countries have sovereign rights over their genetic resources and already included the principles of Access and Benefit Sharing (ABS). These ABS principles have been further operationalized in the Nagoya Protocol, which entered into force in 2014.

This paper addresses the transformation of international law, The Convention on Biological Diversity (CBD) and its Nagoya Protocol on Access and Benefit Sharing (NP), into national law. Those convention and protocol have established an Access and Benefit Sharing (ABS) system between utilizers and providers of genetic resources, including for indigenous people. One of the objectives of treaties it to obligate States to make law to ensure the rights of indigenous people for benefit sharing. Indonesia and Thailand are megadiversity countries and also the parties of the treaties. This paper tries to compare Indonesia and Thailand in transforming the ABS law into their national legal system and how the judges in Indonesia and Thailand use international treaty in deciding the cases. CBD is the starting point of the ABS concept for legal rights or interests that can be owned in relation to genetic resources. In this sense ABS is one of the new and innovative legal concepts introduced in international law. However, the CBD has only created a concept of ABS rights policy. Therefore, the concept of ABS rights of indigenous peoples needs to be formulated in national law by enacted the rights of indigenous peoples related to genetic resources.

BackgroundGlobal challenges related to access and benefit sharing (ABS) of biological resources have become a key concern in the area of research on herbal medicines, ethnopharmacology, drug discovery, and the development of other high value products for which Intellectual Property protection can be secured. While the Convention on Biological Diversity (CBD, Rio 1992) has been recognized as a huge step forward, the implementation of the Nagoya Protocol (NP) and of new forms of collaboration often remain unresolved, especially in the context of “the fair and equitable sharing of benefits arising from the utilization of genetic resources” (Convention on Biological Diversity, 2011). The vision and the specific implementation of this international treaty vary from country to country, which poses additional challenges.AimsUsing a case study approach, in this analysis we aim at understanding the specific opportunities and challenges for implementing international collaborations regarding ABS in six Latin American countries—Chile, Colombia, Guatemala, México, Panama, and Peru. Based on that analysis, we provide recommendations for the path ahead regarding international collaborations under ABS agreements in ethnopharmacological research.Results and DiscussionsThe implementation of the NP varies in the six countries; and while they are all rich in biodiversity, access and benefit sharing mechanisms differ considerably. There is a need to engage in a consultation process with stakeholders, but this has often come to a halt. Institutional infrastructures to implement national policies are weak, and the level of knowledge about the NP and the CBD within countries remains limited.ConclusionsDifferent policies in the six countries result in very diverse strategies and opportunities relating to the equitable use of biodiversity. A long-term strategy is required to facilitate a better understanding of the treaties and the resulting opportunities for a fairer development and implementation of transparent national polices, which currently differ in the six countries. So far, the benefits envisioned by the CBD and the NP remain unfulfilled for all stakeholders involved including local communities.

The Republic of France is fully committed to the implementation of the 1992 Convention on Biological Diversity (CBD) and its Protocol on access and benefit sharing (ABS) both as a sovereign country and as a member of the European Union (EU). In connection with France’s status as an EU member State, the country is legally bound by Regulation (EU) 511/2014 on ABS which implements user measures of NP in the EU. In 1994 and 2016 respectively, France became party to the CBD and 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. France considers itself as a megadiverse country, based on its unique position in Europe and the rich biodiversity found in its overseas territories. However, as a technologically advanced country, France is equally a major user of genetic resources. This chapter explores how France domesticates the NP on ABS from the perspectives of both a supplier and a user of genetic resources and associated traditional knowledge. It examines the extent to which the ABS regulatory infrastructure of France that has been constructed after the entry into force of the NP in 2014, complies with the NP. The chapter demonstrates that the post NP ABS regulatory framework of France is de jure compliant with the letter of the NP. However, questions may be asked about the de facto compliance, which is, whether the spirit of the NP is properly embedded in the ABS regulatory framework of France. In their current versions, the ABS regulatory instruments of France do not appear to be highly reassuring to other supplier countries of GR that they are capable to ensure that all the users of illegally and/or inappropriately accessed resources are seriously scrutinized.KeywordsNagoya protocolABS regulationsGenetic resourcesMegadiverse countriesCompliance