21 de septiembre de 2022
The Impact of the Implementation of the 1992 UN Convention on Biological Diversity and the 2010 Nagoya Protocol in Europe Union and the Andean Community: A Comparative Analysis
Por: Carlos A Conde G - LLB, MA, PhD
The Andean Community has implemented the 1992 UN Convention on Biological Diversity (CBD) through Decision 391 of 1996. Particularly, the wording of the Decision 391 materialized the third objective of the CBD, i.e. “the fair and equitable sharing of the benefits arising out of the utilization of genetic resources” (Article 1 of the CBD), for the Andean countries: Bolivia, Colombia, Ecuador and Peru. Although there have been important efforts in the Andean countries to materialize this objective, its implementation has been slow and, in most of cases, fruitless in terms of securing benefit sharing, particularly transfer of technology. It has also proved to be a regulatory burden for local researchers.
On the other hand, the European Union in 2014 implemented the CBD and its 2010 Nagoya Protocol through the Regulation 511 of 2014 which has changed the rules for researching on genetic resources and traditional knowledge association with genetic resources in the Union. Yet, researchers have also complained of the effect of the Regulation in carrying out research on genetic resources and traditional knowledge. This paper aims to compare briefly both experiences of implementation of “fair and equitable sharing of the benefits” related to the use of genetic resources provisions in both jurisdictions. It particularly reflects on the experience of local research in Colombia, one of the four countries in the Andean Community, and impact reports of the EU to assess whether the implementation of the CDB and the Nagoya Protocol have improved “fair and equitable sharing of the benefits” arising of the use of genetic resources and traditional knowledge associated with genetic resources in the Andean Community, particularly in Colombia, and the EU.
This paper is divided as follows: the first part explains the main provisions of the CDB, the Nagoya Protocol, the Andean Decision 391 and the EU Regulation 511. The second part analyses evidence in Colombia to assess the effectiveness of the Decision 391 in the Andean country. It also studies an impact report to evaluate Regulation 511.
The Text of the CBD, the Nagoya Protocol, Decision 391 and Regulation 511.
The CBD is mostly a treaty related to conservation and sustainable use of biodiversity (Glowka et al., 1994; Swanson, 1999). However, developing countries, particularly those rich in biodiversity, negotiated to include a third objective in the convention: “the fair and equitable sharing of the benefits arising out of the utilization of genetic resources, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies” (Article 1). This was a trade off since provision on conservation and sustainable use of biodiversity would basically affect the use of natural resources on developing countries rather than developed ones (Swanson, 1999).
The third objective is developed in more detail in Articles 2, 3, 8 (j) and 15 of the CDB, and, subsequently, amplified and clarified by the Nagoya Protocol. The latter does not derogate from or amend the CDB; instead, it aims to clarify the Convention’s scope (Greiber et al., 2012). Article 2 brings the definitions employed including genetic resources. The term is fundamental as the third objective centers on the use of “genetic resources”. Article 2 defines genetic resources as ‘genetic material of actual or potential value’, while genetic material means ‘any material from plant and animal, microbial, or other origin containing functional units of heredity’. Eventually, the Nagoya Protocol adds two terms in order to clarify the scope of Article 2 of the CBD: ‘Utilization of genetic resources and ‘derivative’ in Article 2 (c) and (e) of the Nagoya Protocol respectively. The former focuses on the different uses or utilization given to genetic resources, for instance, in R&D for drug development processes. The Nagoya Protocol’s definition of ‘utilization of genetic resources’ aims to clarify the definition of genetic resources so as to include not only the actual or potential value of genetic material (with functional units of heredity), but also the uses given to genetic resources.
The CBD also contemplates other provisions that develop the third objective. Articles 3 and 15 entitles countries the sovereign right to determine who can access their genetic resources and under what conditions. Yet, Article 15 also sets up minimum requirements to implement the CBD locally. These are (i) prior informed consent, including from indigenous and local communities (see also Article 8(j)); and (ii) how to reach an agreement with developing countries rich in biodiversity. But, Article 15 also allows countries not to adopt any of these requirements. For instance, developed countries such as Germany and the UK decided at that time not to implement these requirements at the national level. But as developing countries grew frustrated by the lack of national and regional legislation that would obligate developed countries to enforce the CBD in their jurisdiction, they pushed for a more comprehensive treaty (Buck & Hamilton, 2011; Correa, 2011). As a result, the Nagoya Protocol entitled developing countries to secure access and control of their genetic resources beyond their borders. Consequently, Articles 15 and 16 of the Nagoya Protocol calls on all countries members to adopt mechanisms of compliance to ensure that the use of genetic resources and traditional knowledge within their territory have been lawfully accessed according to CBD and the Nagoya Protocol in developing countries rich in biodiversity.
Having explained the basics of the CBD and the Nagoya Protocol, this paper briefly explores the way in which developing countries such as the Andean ones, which host a significant world ethnic and biological diversity, have implemented the CBD. In the case of the Andean Community, its members have only implemented the CBD. There is no foreseeable regional initiative at the moment to implement the Nagoya Protocol. First, Decision 391 is based exclusively on the concept of sovereignty over genetic resources (Articles 5 and 6). This means that the Andean Community law on access to genetic resources is subject to the sovereignty of states (Article 5).
As a result, Article 6 of Decision 391 establishes that genetic resources are subject to a property regime in which Andean state members could ensure that those resources are not transferable. Second, Decision adopts almost entirely the wording of Article 2 of the CBD on the definition of genetic resources. However, Decision 391 goes further, by including elements that do not contain functional units of heredity, such as by-products. According to Article 2 of Decision 391, by-products include any molecule, a combination or mixture of natural molecules, including crude extracts of live or dead organisms of biological origin that come from the metabolism of living beings.
Regarding traditional knowledge associated with genetic resources, Decision 391 fails to include any definition regarding traditional knowledge associated with genetic resources. Nonetheless, Article 1 of Decision 391 brings a broad definition of communities, which includes indigenous, Afro-American and local communities in one concept, as a group whose own socio-economic and cultural conditions makes different from the “national collectively” and which are governed by its own costumes, laws and traditions. The obligations imposed by Decision 391 also include important procedural obligations. Each Andean Community member must create a procedure under which users of genetic resources seeking to access those resources (which are broadly defined) must obtain prior informed consent, and secure mutually agreed terms. State members must appoint a local authority in charge of that procedure. For instance, in Colombia, the local authority is the Ministry of the Environment.
Meanwhile, as the Nagoya Protocol creates obligations for countries that are not necessarily rich in biodiversity, such as most of the European countries, the EU implemented the Nagoya Protocol through Regulation 511. This Regulation establishes two important elements to comply with the CBD and the Nagoya Protocol: (1) users and due diligence; which requires users of genetic resources to exercise due diligence to comply with the requirements of the regime on access to genetic resources and benefit sharing and traditional knowledge associated with genetic resources, and (2) measures of monitoring users’ compliance which requires that each member state of the EU should establish a competent authority to oversee that users’ generic resources comply with what is established in the Regulation 511 and the Nagoya Protocol, as well as creating a focal point that provides information about the implementation of the regulation. It also creates disclosure obligations for public funded research, which means that researchers should disclose where and how the genetic resources were obtained.
The previous section explains the different obligations created by the implementation of the CBD and Nagoya Protocol for researchers, particularly, to obtain prior informed consent, reach agreements with the country’s host and communities (if there is any indigenous community associated with genetic resources), and ensure that local laws on access are fully met. This has led to create a legal extra burden for researchers in those countries because it requires to comply with further legal obligations that are not usually required in the context of applied research.
In fact, in the case of Andean countries, particularly in Colombia, data from semi-structured interviews, local researchers and from market traders in two locations where medicinal plants demonstrate that, in practice, there is a fragmented implementation of the CBD in Colombia (Conde-Gutiérrez, 2021). In particular, the efforts to secure benefit sharing have targeted mainly local researchers creating a burden on carrying on research on genetic resources (Conde-Gutiérrez, 2021). Also, documentary information pointed out that there has been only one research with indigenous community that has led to benefit sharing agreement with the community (Goldstein, 2019). The total of agreements that does not involve ethnic minorities is 421 agreements (Dirección de Bosques Servicios Ecosistémicos y Biodiversidad-Ministerio de Medio Ambiente, 2022). This illustrates how little local researchers are interested in investigating genetic resources associated with traditional knowledge.
Meanwhile, the EU has reported that researchers have complained about the burden of researching on genetic resources. A 2020 preliminary analysis of the EU Regulation evidence the difficulties for researchers (MILIEU, 2020). First, the findings of the report point out that researchers lost resources and time on “scoping” whether developing and developed countries, where the research activity on genetic resources take place, have implemented either the CBD or the Nagoya Protocol. This has led within and outside of the EU to diverse approaches in the implementation of the international regime (MILIEU, 2020). As a result, delays and extra costs are which has conducted to “hidden cost” for research projects. It also has ended up in a strategic disadvantage for EU companies and researchers as other developed countries such as the US and Japan have not implemented the Nagoya Protocol.
The comparative analysis of the Andean Community and EU demonstrates a difficulty in creating legislation that encourages research on genetic resources and traditional knowledge associated with genetic resources. Further qualitive and quantitate research is required to find ways to avoid extra burden and costs for researchers to encourage further investigation that eventually could lead to fairer and more equitable benefit sharing arising from the use of genetic resources and traditional knowledge associated with genetic resources.
Buck, M., & Hamilton, C. (2011). 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. Review of European Community & International Environmental Law, 20(1), 47–61. https://doi.org/10.1111/j.1467-9388.2011.00703.x
Conde-Gutiérrez, C. A. (2021). Access to Genetic Resources and Sustainable Innovation in the Health Industry and Health Research: A Colombian Legal Perspective. Universidad Externado de Colombia.
Correa, C. M. (2011). Implications for BioTrade of the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization. http://www.unctad.org/biotrade
Dirección de Bosques Servicios Ecosistémicos y Biodiversidad-Ministerio de Medio Ambiente. (2022). Seguimientos a los contratos de acceso a recurso genéticos Febrero 2022. https://www.minambiente.gov.co/wp-content/uploads/2021/10/Estado-de-las-solicitudes.pdf
Glowka, L., Synge, F., McNeely, H., & JA Gundling, L. (1994). A guide to the convention on biological diversity (Issue 333.95 G946). IUCN, Bonn (Alemania). Environmental Law Centre IUCN, Gland (Suiza). Biodiversity Programme.
Goldstein, J. A. (2019, February). La protección equitativa de la tecnología derivada de los bosques tropicales. OMPI Revista. https://www.wipo.int/wipo_magazine/es/2019/01/article_0005.html
Greiber, T., Peña, S., Ahrén, M., & Nieto, J. (2012). An explanatory guide to the Nagoya Protocol on access and benefit-sharing. IUCN.
MILIEU. (2020). Analysis of implications of compliance with the EU ABS Regulation for research organisations and private sector companies. https://ec.europa.eu/environment/nature/biodiversity/international/abs/pdf/ABS%20Regulation_Report%20on%20Compliance%20Implications%20for%20public%20and%20private%20sectors.pdf
Swanson, T. (1999). Why is There a Biodiversity Convention? The International Interest in Centralized Development Planning. International Affairs, 75(2), 307–331. https://doi.org/10.1111/1468-2346.00074