Convention on Biological Diversity and the Nagoya Protocol
The CBD addresses biodiversity irrespective of whether it is terrestrial or aquatic in origin. It has three main objectives: the conservation of biodiversity, the sustainable use of its components and, while declaring the sovereignty of States over their natural resources (article 3), it encourages the creation of access and benefit-sharing (ABS) mechanisms when it comes to the exploitation or utilization of genetic resources (art.1 & 15). This last objective was devised to share the costs as well as the benefits of biodiversity conservation between developed and developing countries. Whilst ABS discussions are often limited to questions around the sharing of monetary benefits from research and development, it should be recognized that biodiscovery rarely results in lucrative patents and products. Thus, non-monetary benefits must also be considered. Furthermore, the objective of ABS is broader than promoting the sharing of the benefits gained from the use of genetic material. ABS is also about facilitating access to genetic resources (art. 15.2).
In the context of ABS for GRs, the two main players involved are the provider and the user. The provider is to be understood as a country that is a party to the Nagoya Protocol, and which is “the country of origin of such resources or a Party that has acquired the genetic resources in accordance with the CBD” . The user of GRs is “a natural or legal person that utilizes genetic resources or traditional knowledge associated with genetic resources.”
Figure: Process and content of Mutually Agreed Terms. Source: CBD Secretariat, Frequently Asked Questions on Access and Benefit-Sharing, at: www.cbd.int/doc/programmes/abs/factsheets/abs-factsheet-faqs-en.pdf
The relationship between a provider and user is based on negotiations in good faith. This clearly means that although a providing country is perfectly entitled to regulate access to its GRs and require benefit-sharing arrangements, it cannot impose such arrangements to the user in an arbitrary manner and the user remains free to refuse an arrangement and source GRs elsewhere. A provider country might require in its ABS national legislation that access to its GRs is conditional to obtaining prior informed consent (PIC) and to negotiating MAT that regulates the conditions of utilization o the GRs. In these cases those are two steps that need to be taken by scientists when they wish to become “users” of GRs in the meaning of the ABS regime. Please note that it is a country’s sovereign right to not regulate access to its GRs, in which case obtaining PIC and MAT are not necessary, and the use of GRs from that country are free and unrestricted (unless otherwise specified for example in any other wildlife legislation and/or regulations about national parks or marine protected areas). PIC should be issued in a written decision by the competent national authority (CNA) of the providing country, which can take the form of a permit or its equivalent. If this permit is registered in a CBD database called the ABS Clearing-House, it will constitute an internationally recognized certificate of compliance (IRCC).
In 2010 the Conference of the Parties to the CBD adopted the Nagoya Protocol, which further elaborates the CBD’s ABS mechanism and promotes the development of worldwide ABS frameworks which will enable stakeholders to better understand and comply with national ABS procedures. In addition, the Protocol clarifies some aspects of the CBD, expressly including biochemical compounds within the scope of the framework and providing examples of both monetary and non-monetary benefits in its Annex.
The main obligations provided by the Nagoya Protocol can be divided in three main pillars:
- Access obligations, if enacted, must be clear, transparent and fair and provide rules and procedures for prior informed consent (PIC) and mutually agreed terms (MAT);
- Benefit-sharing obligations must be subject to MAT between provider and user, include research and development, subsequent applications and commercialization, and may be monetary and/or non-monetary;
- Compliance obligations must be ensured through the adoption by user countries of legislative and regulatory measures, the respect of contractual obligations contained in MAT, and the monitoring of the utilization of GRs by user countries, including by the means of checkpoints.