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Costa Rica Access to Genetic Resources Law (English) Costa Rica

The Biodiversity Law

Law No. 7788

Entered into force, April 30, 1998

Unofficial Private Translation (relevant provisions only)

CHAPTER I -- GENERAL PROVISIONS

Article 1 -- Objective

The objective of the present law is the conservation of biodiversity and the sustainable use of resources, as well as the just distribution of benefits and derivatives.

Article 2 -- Sovereignty

The State has complete and exclusive sovereignty over the components of biodiversity.

Article 3 -- Scope of Application

This law will be applied to components of biodiversity that are under the sovereignty of the State, as well as to the processes and the activities made under its jurisdiction or control, independently of those whose effects are pronounced inside or outside the subject zones of national jurisdiction. This law will specifically regulate the use, the handling, the knowledge and the right distribution of the benefits and costs derived from the use of the components of biodiversity.

Article 4 -- Exclusions

This law will not be applied to the access to biochemical and human genetic material, which will continue to be regulated by the General Law of Health, no. 5395, of 30 of October of 1973, and by related laws. These provisions do not apply to the exchange of biochemical and genetic resources or to the associated knowledge of practices, uses and customs, for noncommercial purposes, between the indigenous and local communities.

This law does not affect university autonomy in the matter of teaching and investigation in the field of the biodiversity, except commercial research.

TRANSITORY. - Public universities, in coordination with the National Council of Directors, within one year of entry into force of this law, will establish in their internal regulations, the controls and the regulations applicable exclusively to academic activity and of research relating to access to biodiversity for noncommercial purposes. Universities that do not define suitable controls in the required period, will be subject to the ordinary regulation of this law.

Article 5. - Framework of Interpretation

This legal ordering will serve as a framework for the interpretation of the rest of the norms that regulate the matters subject of this law.

Article 6. - Public dominion

The biochemical and genetic properties of wild or domesticated components of biodiversity are of public dominion. The State will authorize the exploration, the investigation, the bioprospecting, and the use of components of biodiversity that constitute public properties, as well as the use of all the genetic and biochemical resources, by the norms of access established in chapter V of this law.

Article 7. - Definitions

This law must be interpreted in agreement with the following definitions:

1. Access to the biochemical and genetic elements: Action to obtain samples of existing components of wild or domesticated biodiversity, in conditions ex- situ or in situ, and associated knowledge, with aims of basic investigation, bioprospecting or economic use.

2. Biodiversity: Variability of living organisms of any source, and among terrestrial, air, marine, and aquatic ecosystems, or other ecological complexes. It includes the diversity within each species, as well as between species and the ecosystems of which it composes. For the effects of this law, they will be understood as included in the term biodiversity, the intangible elements, as they are: the traditional knowledge, innovation and practice, individual or collective, with real or potential value associated with biochemical and genetic resources, protected or not by systems of intellectual property or systems sui generis of registry.

3. Bioprospecting: The systematic search, classification and investigation for commercial purposes of new sources of chemical compounds, genes, proteins, microorganisms and other products with present or potential economic value, that are in biodiversity.

4. Biotechnology: Any technological application that uses biological systems, living organisms or derivatives thereof to make or to modify products or processes for a specific use.

5. Natural Collections: Any systematic collection of specimens, living or dead, representative of plants, animals or microorganisms.

6. Knowledge: Dynamic product generated by a society through time and different mechanisms, produced in a traditional way, as they are generated by scientific practice.

7. Conservation ex- situ: Maintenance of the elements of the biodiversity outside its natural habitat, including collections of biological material.

8. Conservation in situ: Maintenance of the elements of the biodiversity within natural ecosystems and habitat. It also includes the maintenance and the recovery of viable populations of species in their natural surroundings; in the case of domesticated or cultivated species, in the surroundings in which they have developed their specific properties.

9. Prior Informed Consent. Procedure by means of which the State, landowners or local and indigenous communities, as applicable, receive all demanded information prior to consenting to access to their biological resources or associated intangible components thereof, upon mutually agreed terms.

10. Diversity of species: Variety of wild or domesticated species within a specific space.

11. Genetic Diversity: Frequency and diversity of genes or genomes, that comprises the diversity within a species.

12. Ecosystem: Dynamic complex of communities of plants, animals, fungi and microorganisms and their physical environment, interacting as a functional unit.

13. Biochemical Element: Any material derived from plants, special animals, fungi or microorganisms, that contain specific characteristics, molecules or tracks for disenarlas.

14. Genetic Elements: Any material of plants, animals, fungi or microorganisms that contains functional units of heredity.

15. Species: Assembly of organisms able to reproduce with each other.

16. Domesticated or cultivated species: Species selected by human beings to reproduce voluntarily.

17. Exotic species: Species of flora, fauna or microorganism, whose natural geographic range does not correspond to the national territory and is encountered in that country, as a product of voluntary human activities or not, as well as by the activity of the species itself.

18. Evaluation of environmental impact: Scientific-technical procedure that allows the identification and prediction of which effects will be exerted on the environment an action or specific project, quantifying them and weighing them to lead to the decision making. It includes specific effects, their global evaluation, alternatives of greater environmental benefit, a program to control and mitigate the negative effects, a program of monitoring, a program of recovery, as well as the guarantee of environmental enforcement.

19. Habitat: Place or environment where an organism or a population exists naturally.

20. Fungi: Unicellular and multicellular, devoid organisms of chlorophyll and pertaining to the phylum Fungi.

21. Innovation: Any knowledge that added improved use or value to the technology, properties, values and processes of any biological resource.

22. Genetic manipulation: Use of genetic engineering to produce genetically modified organisms.

23. Microorganism: Unicellular and multicellular organisms able to make their own vital processes, independently of other organisms. It also includes viruses.

24. Genetically modified organisms: Any organism altered by means of the deliberate insertion, deletion, rearrangement or other manipulation of deoxyribonucleic acid, by means of techniques of genetic engineering.

25. Country of origin of genetic resources: The country that possesses resources in conditions in situ.

26. Country that contributes to resources genetic resources. Country that provides access to in situ genetic resources, including populations of the wild and domesticated species, or sources ex situ, that originated or not in that country.

27. Permission of access: Authorization granted by the Costa Rican State for bioprospecting, acquisition, or commercialization of genetic materials or biochemical abstracts of components of biodiversity, as well as its associated knowledge of people or institutions, nationals or foreigners, requested by means of a procedure created in this legislation, according to permits, contracts, agreements or concessions.

28. Natural resource: All biotic and abiotic elements of nature that are exploited, for commercial or noncommercial purposes.

29. Transgenic resource: Biotic natural resource that has been manipulated by genetic engineering that alters the original genetic constitution of the resource.

30. Restoration of the biological diversity: All activity directed to the recovery of the structural and functional characteristics of the original diversity of a determined area, with conservation aims.

Article 8. - Environmental function of the immovable property

As part of the economic and social function, the immovable properties must comply with an environmental function.

CHAPTER V

ACCESS TO GENETIC AND BIOCHEMICAL ELEMENTS AND PROTECTION OF ASSOCIATED KNOWLEDGE

SECTION I -- GENERAL NORMS

Article 62 -- Competence/jurisdiction

It corresponds to the Commission to propose access policies for genetic and biochemical components of biodiversity ex situ and in situ. The Commission must be consulted in requested procedures for intellectual rights protections relating to biodiversity.

These provisions will constitute the general norms for the access to the genetic and biochemical components and for the protection of intellectual rights relating to biodiversity, to which the administration and interested individuals must submit. To be effective before third parties it must be published previously in the Gazette.

ARTICLE 63. - Basic requirements for access

The basic requirements for access will be:

1. - The prior informed consent of the representatives of the place where the access is occurs, the regional council of Areas of Conservation, the indigenous owners of property or authorities, when access is in their territories.

2. - The endorsement of this prior informed consent by the Technical Office of the Commission.

3. - The terms of technology transfer and equitable distribution of benefits, when they exist, agreed to in the permissions, agreements and concessions, as well as the type of protection of the associated knowledge that demands the representatives of the place where access occurs.

4. - The definition of the ways in which these activities will contribute to the conservation of the species and the ecosystems.

5. - The designation of a resident legal representative in the country, when one is domiciled physically or legally abroad.

ARTICLE 64. - Procedure

By means of registered formal procedure in official file, the Technical Office of the Commission will transact all negotiations required by this title.

When the final act of the procedure can grant individuals rights to components of biodiversity under public dominion or can cause serious damage to individuals, obligations are imposed on them to suppress or deny to them subjective rights or by any other way that gravely or directly injures legitimate rights, the subject must be transacted by means of the ordinary procedure established by the General of the Public Administration Law, except with respect to resources to which paragraph f) of article 14 of this law applies.

The same applies during the instruction, when a contradiction or a competition between interested parties arises before to the Administration.

For all the other cases, the Technical Office will follow summary procedures.

ARTICLE 65. - Prior informed consent

The Technical Office must require from interested parties, with the request for access to distinct types of components of biodiversity, that they enclose the prior informed consent, granted by the landowner where they develop the activity, or with the authority of the indigenous community when the activity is in the indigenous territories and the Director of the Conservation Area.

ARTICLE 66. - Right to the cultural objection

The right of local and indigenous communities to oppose access to their resources and associated knowledge for cultural, spiritual, social, economic or for other reasons is recognized.

ARTICLE 67. - Registry of rights of access on genetic and biochemical components

The Technical Office of the Commission will organize, maintain, and update a permanent Registry of access rights to genetic and biochemical components. The Director of the Technical Office of the Commission will also be the Director of the Registry and the civil employee responsible for the safekeeping and authenticity of the registered information.

The information in the registry will be publicly accessible, except when industrial secrets that must be protected by the Registry, except if biosafety reasons require public accessibility.

ARTICLE 68. - General rule of interpretation

Without prejudice to the implementation of the provisions relative to trade in endangered species of flora and fauna, of the application of sanitary and phytosanitary measures, technical norms and of biosafety, the provisions of this title will not constitute a restriction or obstacle to trade. Any contrary interpretation will be declared null by the administrative authority or judicial, as applicable.

SECTION II -- PERMISSIONS OF ACCESS TO COMPONENTS OF BIODIVERSITY

ARTICLE 69. - Permission of access for the investigation or bioprospecting

All program of research or bioprospecting for genetic or biochemical material of biodiversity that intends to be conducted in Costa Rican territory, requires an access permission.

For the collections ex situ properly registered, the regulation of this law will fix the procedure of authorization for their respective permissions.

ARTICLE 70. - Subjective term, limits, components and territory

The permission of access indicated in the previous article will be established by a maximum term of three years, and can be extended upon the opinion of the Technical Office of the Commission.

These permissions grant an investigator or research center, are personal and nontransferable; they are limited materially to those genetic components or biochemicals authorized and they can only be used in the area or territory specifically indicated in the permission.

ARTICLE 71. - Characteristics and conditions

The permissions of access for research or bioprospecting do not grant rights of actions or delegation; they only allow such activities on components of biodiversity previously established. In the permissions it will be stipulated clearly: the certificate of origin, the possibility or the prohibition to extract or to export samples or, in its defect, their duplication and deposit; periodic reports, verification/monitoring and control, the public nature and ownership of the results, as well as any other condition that, given the rules of applicable science and the technique, are necessary in opinion of the Technical Office of the Commission.

These requirements will be determined in different form for noncommercial research; but in the first case, it will have to be proven completely that a profit interest does not exist.

ARTICLE 72. - Requirements of the request

All requests must be submitted to the Technical Office of the Commission and must contain the following requirements:

1. - Complete name and identification of the interested person. If it is not a private person, it must identify title holder and the power under which it manages.

2. - Complete name and identification of the professional or the responsible researcher.

3. - Exact location of the place and the components that will be the object of research, with an indication of the landowner, the administrator or possessor of the real property.

4. - A description of the scope of the research and the possible environmental impacts.

5. - Objectives and purpose of the research.

6. - Manifestation of which the previous declaration has been done under oath.

7. - Place for notifications in the perimeter of the address of the Technical Office of the Commission.

The request must be accompanied by prior informed consent, granted by the appropriate person, according to article 65.

ARTICLE 73. - Voluntary registry of physical or legal people in bioprospecting activities

The physical or legal people who will undertake the bioprospecting activities, must register previously in the Registry of the Commission. This act does not grant rights to carry out specific activities of bioprospecting.

ARTICLE 74. - Authorization of agreements and contracts

The Technical Office of the Commission, must authorize the signed agreements and contracts between individuals, nationals or foreigners, or among them and the institutions registered for the effect, if they contemplate access to the use of genetic and biochemical components of Costa Rican biodiversity. In order to transact them and to approve them, they will have to fulfill the requirements of articles 69, 70 and 71.

Public universities and other centers properly registered may sign in periodic form framework agreements frame with the Commission, to transact the permissions of access and operational reports. In these cases, the legal representatives of the universities or institutions that take refuge in this benefit, will be penal and civilly responsible by the use that occurs him.

ARTICLE 75. - Concession

When the Technical Office authorizes the constant noncommercial use of the genetic material or biochemical abstracts, the interested party must obtain a concession for those explorations; for it, the General Norms will be applied that dictate the Commission.

ARTICLE 76. - General rules for the access

In addition to the requirements specifically indicated in preceding articles, in the resolution of the Technical Office, in accordance with the General Norms of the Commission, the obligation is established that the interested party must deposit up to ten percent (10%) of the research costs and up to fifty percent (50%) of the royalties collected in favor of the National System of Areas of Conservation, the indigenous territory or the private proprietor that provides access to components; in addition, it will be determined the amount that in each case the interested parties must pay in expenses of proceedings, as well as any other benefit or technology transfer that comprises of the prior informed consent.

SECTION III -- PROTECTION OF THE RIGHTS OF INTELLECTUAL

AND INDUSTRIAL PROPERTY

ARTICLE 77. - Recognition of the innovation forms

The State recognizes the existence and validity of the forms of knowledge and innovation and the necessity to protect them, by means of the use of the appropriate legal mechanisms for each specific case.

ARTICLE 78. - Form and limit of the protection

The State will grant the protection indicated in the previous article, among other forms, by means of patent, commercial secret, right of the fitomejorador, sui generis communitarian intellectual right, copyright, farmer's rights. except:

1. - the sequence of deoxyribonucleic acid per se.

 

2. - plants and the animals.

3. - microorganisms not genetically modified.

4. - essentially biological procedures for the production of plants and animals.

5. - natural processes or cycles themselves.

6. - inventions essentially derived from knowledge associated with traditional or cultural biological practices in the public dominion.

7. - The inventions that, if exploited commercially in monopolistic form, could affect the processes or farming products considered basic for feeding and health of the inhabitants of the country.

ARTICLE 79. - Congruence of the system of intellectual property

The intellectual property rights in the forms indicated by the first paragraph of the previous article, will be regulated by the specific laws of each institute. Nevertheless, the resolutions that are taken in the matter of protection of intellectual property related to biodiversity, must be congruous with the objectives of this law, in application of the integration principle.

ARTICLE 80. - Obligation to consult

The National Office of Seeds, as the Registry of Intellectual Property and Industrial Property, obligatorily must consult with the Technical Office of the Commission, before granting intellectual or industrial property protection to innovations that involve components of biodiversity. You must always bring the certificate of origin issued by the Technical Office of the Commission and the previous consent.

The founded opposition of the Technical Office will prevent the registration of the patent or protection of the innovation.

ARTICLE 81. - Licenses

The particular beneficiaries of protection of intellectual or industrial property relating to biodiversity will yield, in favor of the State, an obligatory legal license that he will allow him in cases of a declared national emergency, to use such rights in benefit of the collectivity, with the only aim to solve the emergency, with no need of the payment of exemptions or indemnification.

ARTICLE 82. - Sui generis communitarian intellectual rights

The State specifically recognizes and protects, under the common name of sui generis communitarian intellectual rights, the knowledge, the practices and innovations of indigenous and local communities, related to the use of the components of biodiversity and associated knowledge. This right exists and is recognized legally with the sole existence of a cultural practice or knowledge related to the genetic and biochemical resources is legally recognized; a previous declaration, express recognition or official registry is not required; therefore, it can include practices that in the future acquire such status.

This recognition means that none of the forms of protection of the intellectual or industrial property rights regulated in this chapter, special laws, and International Law will affect such historical practices.

ARTICLE 83. - Participatory process to determine the nature and reach of the sui generis communitarian intellectual right

Within the eighteen months following the entry into force of this law, the Commission, by means of his Technical Office and in association with the indigenous and campesina mesas [ed. note: mesas are non-governmental associations for indigenes and campesinas] must define a participatory process with the indigenous and local communities, to determine the nature, the scope and requisites of these right for their definitive normalization. The Commission and the organizations involved will arrange the form, the methodology and the basic elements of the participatory process.

ARTICLE 84. - Determination and registry of the sui generis communitarian intellectual rights

By means of the procedure indicated in the previous article, it will be created an inventory of specific sui generis communitarian intellectual rights to which the communities request protection, and the possibility will be kept open, in the future, to register or recognize other for protection that have the same characteristics.

The recognition of those rights in the Registry of the Technical Office of the Commission is voluntary and gratuitous; it must be made officiously or upon request of the interested ones, without subjection to any formality.

The existence of such recognition in the Registry will force the Technical Office to answer negatively any relevant consultation to recognize intellectual or industrial rights of this element or knowledge. Such refusal, whenever properly founded, will become the grounds even though the right sui generis is not enrolled officially.

ARTICLE 85. - Use of the sui generis communitarian intellectual right

The form in which the sui generis communitarian intellectual right will be used and who can exercise its title will be determined by a participatory process. Also, it will be identified the addressees of their benefits ***

LEGISLATIVE ASSEMBLY. - San Jose, the twenty-third day of the month of April 1998.

Entered into force, April 30, 1998.