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.