The Convention on Biological Diversity (CBD) is an international agreement that recognizes the sovereign rights of the state over biological resources. Recognition of a country’s sovereign rights over biological resources has been the main conception from the beginning of the adoption of the CBD, but substantive discussions of this issue have long continued. In particular, there were active discussions between the parties to achieve the third objective of the CBD, fair and equitable sharing of benefits arising from the use of genetic resources, and as a result, ‘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 on ABS)’ was adopted. The Nagoya Protocol has been facilitating national implementation of the access and benefit-sharing (ABS) since it came into effect in 2014.
The Nagoya Protocol builds on the basic principles of access and benefit-sharing set out in the CBD. The key elements of the ABS framework are based on the grant of Prior Informed Consent (PIC) by a provider to a user and negotiations between both parties to develop Mutually Agreed Terms (MAT) that ensure the fair and equitable benefit-sharing of genetic resources and associated traditional knowledge. This agreement includes, as a prerequisite for access to and use of genetic resources, the sharing of benefits arising from the use of the resources with the provider. Conversely, when countries act as providers of genetic resources, they must provide fair and non-arbitrary rules and procedures for access to genetic resources. The Nagoya Protocol covers genetic resources (GRs) and traditional knowledge (TK) associated with genetic resources, as well as the benefits arising from their utilization.
Most countries have agreed on the international regime for ABS as required by the CBD and the Nagoya Protocol. Nevertheless, ABS implementation is not progressing well. This study examines why ABS response and implementation differ at the international, regional, and national levels vertically, and at the dimensions of institutions and related stakeholders in national implementation horizontally in light of the concept of multi-level governance (MLG). In other words, why is there no consensus in the process of forming an international regime and why are there differences at the individual country-region-international levels? In particular, this thesis seeks to analyze the differences and numerous problems among various domestic stakeholders that contribute to the formation of this regime domestically as well.
From the perspective of multi-level governance, this study closely observes and analyzes the Nagoya Protocol, which is most relevant to the formation of the ABS system under the current CBD regime, especially at the international level, and then moves to the regional level (i.e., the Andean Regime on ABS, such as Decision 391 as a Common Regime on Access to Genetic Resources). Finally, this study focuses on the domestic governance of the Andean region countries (four countries) selected as the case study subjects through observations of important problems and various obstacles in the process of forming the ABS system in these countries through various analysis variables such as administrative capacity, institutional development, building of information sharing system, enforcing of domestic and international cooperation mechanisms, and related key actors who play a major role in the ABS system, including the central government, local governments, various domestic and foreign companies, research centers, local residents—especially indigenous communities in this region—Non-Governmental Organizations (NGOs), and even biological resources (some countries in the region have recently granted ‘Rights of Nature’ to biological resources).
Following these theoretical arguments and background, this study employs four variables for analysis from the author’s perspective, such as: Administrative Governance, Institutional Governance, Data Governance (Information Sharing with Data Forming and Management), and Domestic and International Cooperation Governance to measure the current process of constructing the ABS system in Andean countries. These four variables are a reconstruction from the author’s perspective of the following 10 conditions that the CBD international regime currently requires to be measured to observe the level of participation of ABS member countries: ABS National Focal Point (NFP), Competent National Authority (CNA), Legislative, Administrative, or Policy Measures (MSR), ABS Procedure (PRO), National Model Contractual Clause (NMCC), Internationally Recognized Certificates of Compliance (IRCC), National Websites or Databases (NDB), Checkpoint (CP), Checkpoint Communiqué (CPC), and Interim National Report (NR) on the Implementation of the Nagoya Protocol for supporting the implementation of Nagoya Protocol. From the author’s perspective, the current ABS international regime and its implementation process can also be reclassified again here with the above four variables based on the terms of ‘goverance’, which are considered essential elements for pursuing common interests by encouraging member countries to actively participate in the ABS system.
The criteria for selecting target countries in this study are that each be a megadiverse country with common genetic resources due to shared biodiversity hotspots, and that it be the first country to access genetic resources through Decision 391 on the Common Regime on Access to Genetic Resources in 1996 after the adoption of the CBD. These are countries that have established cross-border ABS systems.
The overall level of statistical analysis of ABS international implementation is showing slow progress because many countries have not yet uploaded national data in the Access and Benefit-Sharing Clearing-House (ABSCH). Only a few countries have worked on implementation at the institutional and information sharing level (e.g. MSR, IRCC). Some countries are only participating in international implementation in the present situation.
Administrative governance depends on government capabilities and collaboration between ministries. NFPs, CNAs, CPs, and NRs are all designated by the government and represent it. The designation of NFP can be shown to be the first step in implementing ABS. With 178 countries registered in NFP, it can be shown that most countries are participating in the beginning stages of ABS implementation, but only some countries have registered CNAs, CPs, and NRs. In some countries, multiple agencies are designated as CNAs and CPs, and if there is no coordination and consultation between agencies, this may lead to delays in the ABS implementation process.
In Institutional Governance, MSR has a high number of registrations in India and Latin America countries such as Mexico, Honduras, Peru, and Colombia. In all, 21 countries have uploaded PROs. Thus, the pace of progress in the institutional dimension is too slow.
In Data Governance (including Information Sharing), only 5 countries have registered NMCCs and 43 countries have registered 59 NDBs; some countries (Portugal 4, Belgium 3, France 3), have uploaded multiple websites. In the case of NDBs, mainly European countries have been building online platforms. Progress in the dimension of Data Governance (including Information Sharing) is slow.
Domestic and International Cooperation Governance is evaluated based on IRCCs and CPCs. The concentration of some countries in IRCCs and CPCs is significant. India’s IRCCs account for more than 70% of the total, and India leads the world in terms of ABS agreements with 3,496 IRCCs, where there is a large gap between India and other countries. Taken overall, there are few commercial agreements and IRCCs related to traditional knowledge regarding genetic resources. Regionally, Latin America has few IRCCs. There are a total of 11 countries that have uploaded CPCs, with multiple CPCs from each. A few countries are thus leading in domestic and international cooperation.
The overall level of statistical analysis of the national implementation of ABS in Andean countries also shows slow progress because many countries have not yet uploaded national data to ABSCH.
Bolivia has designated only an NFP from the perspective of Administrative Governance. Not only has little related information been uploaded, but there are also almost no public data, including ABS genetic resource information, implementation procedures, and implementation examples. Compared to Colombia, Ecuador, Peru, ABS national implementation is the slowest.
Colombia has designated an NFP and CNA from the perspective of Administrative Governance. The NFP and CNA in Colombia are solely designated by the Ministry of Environment and Sustainable Development, so it can be said that the convenience of access to information and the administrative efficiency for providing information are high. In Institutional Governance, Colombia registered 10 MSRs, the highest number of MSRs uploaded of the four countries. Colombia is focusing on specifying ABS domestic laws, policies, and regulatory procedures. In Data Governance (including Information Sharing), Colombia has registered 1 NDB, but the website link cannot be opened. Continuity in data management and continuous updating of information appear to be necessary.
Ecuador has designated an NFP, CNA, and CP. In particular, for the CNA and CP, Ecuador has designated multiple ministries and agencies, which increases the complexity of ABS procedures such as ABS access, PIC and MAT, and benefit-sharing, which can be seen as a factor along the dimension of Administrative Governance that makes implementation difficult. From the perspective of Institutional Governance, Ecuador has registered 6 MSRs that include the contents of GRs and Traditional Knowledge associated with GRs and intellectual property rights (IPRs).
Peru has registered an NFP (1), CNAs (7), and CPs (2) in Administrative Governance. The CNA and CP in Peru comprise multiple ministries and agencies, which increases the complexity of ABS procedures such as ABS access, PIC and MAT, and benefit-sharing, which can be seen as a factor making implementation difficult. In addition, it is the only country to upload a National Report (NR). In Institutional Governance, Peru has registered 10 MSRs and 1 PRO. Most MRSs include the contents of GRs and Traditional Knowledge associated with GRs, protect against acts of biopiracy, and support capacity-building. In 2021, Peru revised the Access to Genetic Resources and Their Derivatives to adapt the Nagoya Protocol and Andean Decision 391 (1996) to national realities. Peru is focusing on further specifying the scope and implementation procedures of ABS for genetic resources. In Data Governance (including Information Sharing), Peru has registered 4 NDBs, but some links cannot be opened. Continuity in data management appears to be necessary. Peru has issued the most IRCCs of the four countries in Domestic and International Cooperation Governance. Most IRCCs in Peru are for non-commercial agreements. Compared to other Andean countries, ABS compliance can be seen as the most active in Peru.
The Andean region countries (all four countries) display obstacles in common in conformity with the four Governance realms (Administrative Governance, Institutional Governance, Data Governance (including Information Sharing), Domestic and International Cooperation Governance). However, the governance analysis results of the statistical analysis in Chapter III and of the individual countries in the literature survey in Chapter IV are somewhat different.
Bolivia from the perspective of Administrative Governance has obstacles in non-persistent R&D investment and lack of private participation in utilizing and commercializing biological resources. From the perspective of Institutional Governance, Bolivia requires a variety of other contracts when making access agreements for genetic resources. This increases the transaction costs and risks borne by the petitioner. Particularly in contracts for knowledge and skills, there are high transaction costs and risks to investment security. In addition, there is the debate over the interpretation of existing laws (i.e., Decision 391). In Data Governance (including Information Sharing), illegal extraction of potential resources has become more prevalent, and the location information of vouchers is being managed increasingly strictly in Bolivia. From the perspective of Domestic and International Cooperation Governance, Bolivia has a particular conflict between the internal interests of traditional communities, local governments and development goals, and the external interests of multinational corporations and other parties pushing for the implementation of multilateral agreements.
From the perspective of Administrative Governance, Colombia appears to have difficulties in applying relevant requirements and ensuring legal certainty with PIC. Building a functional domestic ABS system requires greater clarity on PIC and MAT requirements, particularly where indigenous peoples and local communities are involved. In Institutional Governance, Colombia needs negotiation skills due to the excessively conservative and risk-averse attitude of private enterprises toward commercial purposes. In Data Governance (including Information Sharing), Colombia has no linkage between academia and companies due to issues such as intellectual property rights although the government has invested financial resources into the development of genetic resources, and lack of knowledge about scientific methods and objectives makes it difficult for administrative authorities to evaluate scientific research proposals submitted for ABS access requirements. In Domestic and International Cooperation Governance, the continued violence by armed groups and criminal groups against rural, indigenous, and black communities is also considered an obstacle.
From the perspective of Administrative Governance, Ecuador has a lack of research facilities, a brain drain of young researchers, low pay and poor treatment for researchers, and a poor research infrastructure (environment) that forces researchers to leave the field. There is also a lack of infrastructure and equipment for research and of negotiation capacity for technology transfer. In Institutional Governance, Ecuador has the obstacle of conformity with existing laws (i.e., Decision 391). In addition, in Ecuador, the development of commercial applications has largely failed, resource providers have derived only limited benefits, and incentives for biodiversity conservation have been limited, which constitute obstacles. There is a debate on the Buen Vivir concept that enshrines the rights of nature and its application to public policy. In Data Governance (including Information Sharing), Ecuador has a lack of highly specialized taxonomists and a need for further research and improved knowledge of BES (Biodiversity and Ecosystem Services). In Domestic and International Cooperation Governance, Ecuador has conflicts among stakeholders (i.e., local NGOs) in the access and commercialization process, as well as over profit sharing between companies and indigenous communities.
From the perspective of Administrative Governance, Peru has weak monitoring and supervision regarding compliance with the terms and conditions of access contracts. In Institutional Governance, Peru is struggling to update its procedures and regulations to respond in a timely manner to researchers and other stakeholders requesting formal access to genetic resources and financial difficulties. There is poor coordination between authorities granting access to genetic resources and traditional knowledge. Further clarity is still needed on the responsibilities of the various authorities and the parameters of benefit-sharing negotiations. In Institutional Governance, on the user side, the financial benefits are considered too high by private companies, and on the provider side, indigenous peoples and local communities have limited knowledge of the legal framework and are unable to control illegal access by domestic and foreign users. In Data Governance (including Information Sharing), Peru’s obstacle is that the procedures for accessing genetic resources are complex and bureaucratic. In Domestic and International Cooperation Governance, Peru has a strict regulatory system to apply the Nagoya Protocol, but management and operational failures have led to calls for more training in ABS systems among the actors involved in the process: authorities, national and local officials, scientific communities, indigenous communities, and the general public.