On September 5, 2012, the National Assembly of Nicaragua approved a new Law for the Conservation and Sustainable Use of Biological Diversity. Dictamen de Proyecto de Ley de Conservación y Utilización Sostenible de la Diversidad Biológica. 1 The law implements provisions of the Convention on Biological (CBD) and the Nagoya Protocol to the CBD.
PRAISE FOR THE NEW LAW. As explained in an article published yesterday in Adital, the biodiversity law was first proposed in 1996, and was debated intermittently in the Assembly over the last 16 years. 2 The article quotes Julio Sanchez, an official of the Humboldt Center in Managua, as saying, “This law represents a breakthrough for the country, allowing regulation of conservation and sustainable use of biological diversity and the equitable and fair distribution of benefits among indigenous communities in Nicaragua–those [communities] that, for centuries, have been protecting and conserving our genetic resources.” According to Sanchez, the new legislation is one of the most innovative and modern of Nicaragua’s laws, and it offers “the opportunity to take a decisive step toward the protection of our genetic resources and our culture.”
SCOPE OF THE LAW. The biological diversity law addresses nine primary subjects:
- In situ and ex situ conservation of biological diversity;
- Protected areas;
- Centers of origin of genetic diversity;
- Protection, conservation, and control of genetic resources;
- Access to and use of genetic resources;
- Just and equitable participation in the benefits derived from the exploitation of biological diversity;
- Research regarding biological diversity;
- Repatriation of genetic resources that have been unlawfully removed from the country; and
- Traditional knowledge of indigenous peoples and ethnic communities for the conservation and sustainable use of biodiversity.
FEATURES OF THE LAW. The law contains many features of interest for environmental conservation, sustainable development, agricultural research and development, and environmental law. Some highlights include the following:
- Assertion of Sovereign Rights. In accordance with CBD Article 3, 3 the law declares that “[t]he State exercises [its] sovereign rights over the biological diversity located within its territory, which shall be inalienable, imprescriptible, and indefeasible.”
- Recognition of and Respect for IP Rights. The law declares the state’s respect for and recognition of intellectual property rights, and prescribes that contracts for access to biological and genetic resources shall address the ownership of intellectual property rights over products derived from those resources. The law also declares that, to the extent that intellectual property legislation relates to biological diversity and traditional knowledge, it must be brought into accord with Nicaragua’s system of indigenous rights and the biodiversity law.
- Precautionary Principle. Article 8.4 of the law expressly adopts the precautionary principle of risk evaluation and management:
When there is danger of serious or irreversible damage to biological diversity or its components, or associated knowledge, lack of full scientific certainty should not be used as a reason for postponing measures to prevent damage.
- Responsibility for Costs. The law provides, as a general principle, that users of biological resources must bear the responsibility for environmental and other costs associated with such usage.
- Appointment of Competent Authority. The law appoints the Ministry of the Environment and Natural Resources (MARENA) as the “Competent Authority” to carry out a variety of administrative tasks, including (but not limited to):
- Promulgating regulations governing conservation and sustainable use of biological diversity, and procedures for obtaining access to and sharing benefits from exploitation of genetic resources;
- To grant rights of use such as licenses, permits, authorizations, and rights of access to and exploitation of biological resources;
- To accredit, authorize, designate, and supervise national depositories for storage of biological materials; and
- To coordinate policies for technology transfer related to the conservation of biological diversity.
- Procedures for Accessing Genetic Resources. The law requires the Competent authority to establish a national system of licenses and permits for the access and exploitation of genetic resources, their components, and derivatives. All bioprospecting activities and accessing of genetic resources within Nicaraguan territory will require the filing of an application and approval of a license or permit, as well as a signed contract. The application and related documents will be published, and the Competent Authority will hold a public hearing on the application at least 30 days prior to its approval.
- Application for Access. At a minimum, an application for access must contain the following information:
- The objectives and aim of the research;
- The place of where the resources were extracted;
- The purpose for which access is sought (taxonomy, collection, research, commercialization, among others), and the type and quantity of genetic resources;
- The methodology to be used in research and development;
- The anticipated duration of the research;
- Information about prior use;
- A financial budget; and
- An analysis of the costs and benefits of granting access.
An application for access can be denied for several reasons, including noncompliance with applicable law or regulation, false statements in the application, when the risk assessment associated with the application lacks scientific or technical support or indicates a risk of adverse effects to human health or essential elements of cultural identity, and when the applicant has previously engaged in unlawful activities relating to access to biological or genetic resources.
- Access Contract. In order to obtain access to the desired genetic resources, the applicant must enter into a contract with the Competent Authority setting out the following:
- The object of the contract;
- The rights and obligations of the parties;
- Limitations, applicable time periods, and information about the biological component to be accessed;
- A clause setting forth a just and equitable mechanism for distribution of resulting benefits;
- Determination of intellectual property rights ownership;
- Attribution of credit in any resulting publication; and
- Financial provisions or guarantees to compensate for noncompliance with the contract.
- Sui Generis IP Rights for Traditional Knowledge. The law provides that —
The State expressly recognizes and protects, under the common name sui generis community intellectual rights, the knowledge, traditional practices, and innovations of indigenous peoples and ethnic and local communities related to the conservation and sustainable use of biological diversity and products derived from it, as well as the capacity of [such groups] to make decisions regarding those matters.
These rights are considered part of the cultural patrimony of the groups who possess them, and they may be used only with the prior consent of the rights holder in accordance with applicable law. Furthermore, the law provides that,
Rights of intellectual or industrial property granted to natural or juridical persons over knowledge, practices, and biological resources shall not impede their utilization by indigenous peoples and local and ethnic communities.
- Exclusions. The law excludes from its scope human genetic resources and their derivatives. It also does not apply to exchanges of biological resources among indigenous peoples and local ethnic communities in accordance with their traditional or customary practices, as long as those transactions are not for commercial purposes.
by Shawn N. Sullivan, Oct. 6, 2012.
- See Aprueban ley de conservación y utilización sostenible de la diversidad biológica, Asamblea Nacional (Sept. 5, 2012). ↩
- Giorgio Trucchi, Ley de Biodiversidad aprobada. Ahora se podrá exigir repatriación de recursos genéticos sustraídos ilegalmente, Adital (Oct. 5, 2012). ↩
- Article 3, Convention on Biological Diversity. ↩