COLOMBIA, 1995

Santafe de Bogota, July 20, 1995

CHAPTER 1

ON THE GENERAL PRINCIPLES

Article 1. This Law is based on the following general principles:

1. The Nation exercises sovereign and inalienable rights over the biotic diversity and genetic resources existing in the national territory, in harmony with constitutional principles this sovereignty is shared with the civil society. Therefore, it is the duty and right of all citizens and of the State to jointly protect ethnic and cultural diversity, the natural heritage of the Nation and the integrity of the environment.

2. The biotic, genetic and cultural heritage of the Nation has a strategic character and is a guarantor of integral national security. Therefore, its protection, conservation, management, utilization and restoration must be associated with the promotion of a development which is environmentally sustainable and equitable.

3. It is the duty of the State to promote, plan and orient the national activities, as well as the foreign relations of the State and its cooperation with neighbouring nations, in relation to the conservation, utilization and negotiation regarding the biodiversity which is found in national territory and cross­frontier ecosystems, as well as to regulate the entrance into and departure from the country of biotic and genetic resources (including transgenic ones).

4. All activities related to the protection, utilization and negotiation of biodiversity are based on the principles of bio­ethics, national sovereignty, respect for the self­determination of nations, equity and reciprocity between countries and upon the criteria of national advantage and integral national security, in accordance with the general interest and the multi­ethnic and pluri­cultural character of the Nation.

5. It is the duty of the State to supply the mechanisms which guarantee a just, equitable and effective participation of its citizens in the protection of its collective and individual interests and rights in those decisions which affect the biotic, genetic and cultural heritage, as well as the knowledge, activities and benefits derived from their utilization.

6. It is the duty of the State to establish and provide the mechanisms for evaluating and protecting the traditional and collective cultural knowledge, innovations and practices of local communities which apply to the use, conservation, evaluation, propagation and management of biodiversity and related subjects, respecting the cultural rights of the groups involved.

7. Biological diversity is closely related to cultural diversity. Therefore, it is considered to be of general interest. As a consequence, the mechanisms which are herein considered for the conservation of biodiversity and genetic resources must contribute to the strengthening of this relationship, particularly as regards the National Parks System and other protected areas.

8. The strengthening of the national capacity for the development of distinct forms of generating knowledge and for achieving sustainable development is a matter of priority.

9. The evaluation and use of biodiversity and biotic resources, including genetic ones, is considered to have tangible and intangible components. The former is made up of ecosystems, species, populations and their parts or derivatives; the latter is composed of the knowledge, innovations and cultural practices associated with them, which allow them to be recognised as resources.

10. The country recognises the existence and validity of different forms of knowledge and innovation: those which are based on the collective practices of conservation, selection and improvement by local communities, and that which results from a process of scientific and technological research. The protection of each one of these forms of knowledge must be specific to its character.

11. The country shall adopt the precautionary principle for the adoption of measures destined to prevent or impede genetic erosion, guarantee bio­safety and protect the cultural integrity and knowledge of the local communities.

12. No right of individual intellectual property (patents or others) shall be recognised over micro­organisms, human cells, or parts, tissues or cultures of the same.

13. The dispositions, procedures and acts of the governmental authorities which are in charge of measures related to the object of the present law shall be clear, well­grounded, based on consultation and must be widely divulged.

CHAPTER II

THE OBJECT OF THE LAW

Article 2. The object of the present Law is the following:

1. To protect, conserve and restore the national heritage which is represented by the biological diversity found in national territory, as well as to maintain and improve the conditions which make possible all of the forms of life found in national territory, those which determine the quality of life of human beings and those which contribute to the protection and strengthening of the cultural diversity of the Nation.

2. To promote and support the different ways of generating forms of knowledge and technology within the country, giving priority to the strengthening of national capacity, and to guarantee citizens both access to information and an equitable participation in the benefits which may derive from these.

3. To protect and provide incentives to cultural diversity, placing a value upon the knowledge, innovations and practices of local communities regarding the conservation, utilization and management of biotic and genetic diversity.

4. To regulate the current legal framework on access to biotic and genetic diversity, including parts of biotic material and transgenic resources, as well as their departure from the country and the entrance of biotic resources.

5. To regulate the conditions under which the extraction, production, utilization, storage, industrial utilization, commercialization, release and introduction of biotic, genetic and transgenic resources will be carried out, as well as those applying to physical and chemical elements and products, in such a way that:

(a) the bio­safety and environmental and food security of the country are guaranteed; and

(b) the protection of the national cultural heritage associated with biodiversity, as well as the participation and agreement of the local communities in the taking of decisions to do with these matters and with the distribution of benefits which may derive from them, are guaranteed.

6. To regulate matters related to the individual and collective rights over the knowledge associated with biodiversity in such a way that their protection, recognition and appreciation are guaranteed, in accordance with the cultural ambit in which they are generated.

7. To create the mechanisms which guarantee that the object of this law is applied, as well as sanctions for violations of its postulates.

CHAPTER III

ON DEFINITIONS

Article 3. For the effects of the present Law, the following definitions shall be considered:

"Access": The obtainment with whatever aim of samples of biotic, genetic and transgenic resources, their products, subproducts, derivatives and resulting synthetic products, as well as the knowledge, innovations and practices associated with these.

The activities leading to knowledge, exploration, research, collection, gathering, transformation, utilization, mobilization, commercialization and industrial application of or into those resources, as well as the utilization of populations, individuals, organisms or parts of these as a source of biological, genetic and transgenic resources are considered activities of access.

"Agro­ecosystem": an ecosystem whose functioning depends on continuous human intervention, the physiological limits of cultivation, the interaction between the biotic, abiotic, cultural and technological components and between these and the natural base of sustenance.

"Competent national authority": the public state entity or organism authorized to subscribe or supervise and watch over the compliance with the norms related to one or several of the matters which are the object of the present Law.

"Germplasm bank": forms part of the centres of ex­situ conservation. The collection of genetic material duly stored, systematized and conserved, with the intention of guaranteeing the genetic stability of the lineages contained therein.

"Genetic bank": genetic material conserved in a place and under conditions which permits the maintenance of their its and genetic variability. It permits the continuity of evolutionary processes of the lineages therein represented.

"Benefits": the results of the application of an improvement of a component of biodiversity, which may be of social or environmental utility. It includes economic values, information, access to technologies, cultural supports and others.

"Bio­ethics": a principle based on the respect for the right of natural living beings to co­exist with mankind and perpetuate themselves.

"Bio­prospection": the exploration, research, gathering, making of inventories, taking of samples and taxonomic identification of biotic and genetic resources, ethno­biological knowledge and other associated activities, destined, directly or indirectly, for the identification of promising or effective sources for products or processes.

"Environmental bio­safety": this is defined as the inalienable right of every person or human population to count upon a natural heritage whose diversity can be utilized and which is free from environmental damage which threatens their existence or adversely affects their quality of life, as well as to be free from the danger of being a victim of those damages. It includes the right to exercise their own cultural perspective and utilize their knowledge for the conservation, use, exchange and improvement of the resources included in it, which permits them to guarantee the renewal and efficiency of sustainable ecosystems for their present and future alimentary self­sufficiency, their full development, the conservation of their physical and mental faculties and an optimum quality of life.

"Technological bio­safety": a series of norms and mechanisms which are intended to guarantee security in the research, development, production, application and introduction of organisms which have or have not been genetically modified, or genetic material which has been manipulated, in such a way that present or future harm or damage to human, animal and vegetable health, to ecosystems, to their biotic or abiotic components or to the cultural values of the country which derive from eventual associations produced during the life cycle both of the modified organisms and the organisms which may be generated are prevented and avoided. It includes the group of measures intended to guarantee the individual and collective physical security of the researchers and operatives in the field of bio­technology or associated industries.

"Bio­technology": Every technological application which utilizes biological systems, live organisms, parts of live organisms or their derivatives for the creation or modification of products or processes.

"Ex-situ conservation centre": The person or legally­constituted body which conserves and collects genetic resources away from their in situ conditions. It includes, among others, botanical gardens, herbariums, centres of cultivation, germplasm banks.

"Certificate of Access": A document issued by the Competent National Authority which states that access to the material which is subject to certification has been authorized.

"Intangible component": All individual or collective knowledge, innovation or practice, with a real or potential value, which is associated with the genetic resource or biotic resource which contains it, whether or not it is protected by regimes of intellectual property.

"Local communities": Human groups whose social, cultural and economic conditions distinguish them from other sectors of the national collectivity, and which are completely or partially governed by their own customs or traditions or by a special legislation and which, whatever their legal situation, conserve all or parts of their own social, economic, cultural and political institutions.

"Concession of access": a legal act by means of which the competent national authority, as a representative of the State, confers upon a person or legally­constituted body the right to access to genetic resources, within the terms of the present law.

"Ex-situ conditions": the conditions in which biotic and genetic resources are found outside their natural habitats. Under the present law, lineages which have been submitted to cultivation within their area of origin are excluded from ex­situ conditions.

"In-situ conditions": the conditions in which biotic and genetic resources are found in their ecosystems and natural habitats and, in the case of domesticated or cultivated species, in the cultural contexts in which their specific properties have been developed.

"Prior informed consent": the description employed in the Convention on Biological Diversity is used.

"Conservation of biodiversity": all activities related to the management of biological diversity which, maintaining their usage, guarantee their renewal and natural productivity.

"Ex-situ conservation": understood as the conservation of the components of biological diversity away from their natural habitats.

"In-situ conservation": understood as the conservation of ecosystems and natural habitats and the maintenance and recuperation of viable populations of species in their natural context, and, in the case of domesticated and cultivated species, in the context in which their specific properties have been developed.

"Contract of access": A written and duly authorized agreement between the State and a national or foreign person or legally­constituted body which solicits access to biotic or genetic resources which a supplier holds or which are in areas which are the property of the Nation or which are collective property. It includes, but is not limited to, in-situ sources and to contracts with ex-situ centres of conservation for the transfer of material.

"Cultural rights": refers to the rights of local communities to guarantees that: 1) their cultural beliefs and practices be respected; 2) they are able to continue to develop their own productive and cultural initiatives for the use and conservation of biological diversity and related matters; 3) they may collectively benefit from their traditions and ingenuity; 4) they are compensated for their constant task of conserving biodiversity, creating and developing innovatory technologies and their work of improving and selecting cultivated or domestic lineages or races.

"The rights of local communities": the rights which these communities have for their past, present and future contributions to the propagation, conservation, improvement and availability of biotic and genetic resources.

"Rights of the country of origin": Rights which correspond to the country of origin, in which the sovereign right is recognised to authorize or deny access to the biotic or genetic resources which exist in its territory and to participate in any information or benefit which may derive from research into or the utilization or application of elements, groups or derivatives of its biodiversity. This concept also includes the right of the country over the ex-situ resources which the country has supplied.

"Biological or biotic diversity": The wealth of forms of life including their spatial­temporal organization, their genetic material and their implicit variability, understood as a strategic heritage of the Nation which has intrinsic values which refer to its tangible and intangible components; these latter vary in accordance with the cultural context in which they are framed and with the degrees and forms of knowledge which lead to their recognition as such.

"Genetic diversity": The variation of genes and gene types among and within species or the sum total of the genetic information contained in biotic organisms.

"Ecosystem": a dynamic complex of vegetable, animal and micro­organism communities and their non­living environment which interact as a functional unit, including human beings.

"Genetic Erosion": the loss or decrease of genetic diversity.

"Domesticated species": the taxonomic species or subspecies, race or variety of animal, plant or micro­organism in which evolutionary processes have been influenced by human beings in order to fulfill their needs or interests.

"Native species": the taxonomic species or subspecies, race or variety of animal, plant or micro­organism whose natural area of geographical dispersal extends to national territory and the waters under its jurisdiction.

"Exotic or introduced species": the taxonomic species or subspecies, race or variety of animal, plant or micro­organism whose natural area of geographical dispersal does not extend to national territory nor to the waters under its jurisdiction and which is found in the country as the result of human activity.

"Promissory species": A species whose potential for use has yet to be employed or fully known.

"Wild species": A species whose evolutionary process has not been modified by human intervention.

"Genetic stock": A genetically differentiated lineage which is capable of perpetuating itself.

"Promotion of biodiversity": the group of activities oriented towards the increase and renewal of the natural productivity, in a given area, of wild ecosystems or agro­ecosystems, within a framework of conservation and multiple use.

"Habitat": the place or type of environment in which an organism or a population exists in natural conditions.

"Genetic engineering": Technologies used for the isolation of the genes of an organism, their manipulation in a laboratory and their insertion or substitution at the point occupied by a given gene in a chromosome.

"Innovation": Any knowledge of or technology for the use, properties, values and processes, whether they are individual or collective and accumulative, of any biotic and/or genetic resource which adds an improved use or value to it as the result of such knowledge or technology, whether this be documented, annotated, oral, written, etc. It includes any alteration, modification or improvement of the resource, as well as derivatives which utilize the knowledge of individuals, groups or local communities for the commercialization of the product.

"Micro­organism": The simplest form of known life. A collective denomination which is applied to organisms which are typically unicellular (bacteria, fungi, microscopic algae, protozoans, rickettsias and viruses ).

"Genetically modified organisms": modified plants, animals, algae, fungi and micro­organisms which result from the deliberate insertion, removal, re­arrangement or other manipulation of DNA or RNA by means of technologies of genetic engineering.

"Biotic organization": covers bio­molecules, genes, cells or parts of them, tissues, organs, systems, organisms, colonies, populations and communities of plants, animals or micro­organisms which are found in areas of national territory.

"Country of origin": The country in which the species, organism or genetic stock occurs in natural conditions and where it presumably had its evolutionary origin. It includes those which, having formerly been in those conditions, are found in ex-situ conditions.

"Precautionary principle": The principle according to which the lack of absolute scientific certainty shall not be used as a reason to delay the adoption of effective measures to guarantee bio­safety, impede the degradation of the environment and prevent genetic and cultural erosion when there exists a danger of grave and irreversible damage to biodiversity or of the usurpation of the cultural integrity of local communities.

"Protection or preservation of biodiversity": This refers, respectively, to the tangible and intangible components of the same. With regard to the tangible components, it refers to the forms of conservation in which there are no extraction activities and other uses are restricted. With regard to the intangible components, it is associated with the protection of knowledge.

"Protection of knowledge": the group of actions directed to the maintenance of the cultural integrity of the knowledge, innovations and practices related to biodiversity and the avoidance of the individual and monopolistic appropriation of the knowledge associated with the same.

"Supplier of the resource": The State, person or public or private legally­constituted body which administers or is the legitimate possessor or owner of the area, property, individual or organism in which is found the biotic or genetic resource to which access may be given by means of the corresponding approval of the State. The condition of supplier does not necessarily give a country the character of country of origin.

"Biotic resources": individuals, organisms or parts of them, natural processes, derivatives, micro­organisms, populations or any live component of biodiversity which have an actual or potential value for humanity, whether they are wild, domesticated, cultivated or escaped from domestication.

"Genetic Resources": all material of a biotic nature which contains genetic information of a actual or potential value.

This includes the functional units of inheritance contained in individuals, micro­organisms, viruses, sexual or asexual reproductive material, tissues, cells and parts of them which come from resident or migratory native species, domesticated and wild species or those escaped from domestication, as well as material which has been submitted to genetic manipulation.

"Transgenic resources": all genetic material which has been subject to manipulation which alters its original genetic constitution.

"Restoration of biodiversity": all activity directed towards recovering the structural and functional characteristics of the original diversity of a given area, with the aim of protection or conservation.

"Sustainable use": utilization of the components of biological diversity, in such a way and at such a rhythm that the structure, functioning and productivity, both of the ecosystems and the natural and cultural resources are guaranteed in the long term and which does not occasion the decrease of biological diversity through which is maintained the possibility satisfying the necessities and aspirations of present and future generations.

CHAPTER IV

AREA OF APPLICATION OF THE LAW

Article 4. The present law is applicable to the ecosystems, species, micro­organisms, algae, fungi, cells and continental, coastal, pelagic and island biotic and genetic resources present in national territories, as well as to the migratory species which, for natural causes, are found in national territory.

Article 5. Without prejudice to that set forth in the above article, the present law establishes the lineaments applicable to the intangible component associated with biodiversity.

Article 6. The area of application of this law excludes:

1. Human beings, cells and human genetic resources;

2. The exchange of biotic resources which contain genetic resources or intangible components associated with them which are carried out between local communities for their own ends, based upon their customary practices.

CHAPTER V

ON THE PROTECTION, CONSERVATION, SUSTAINABLE USE AND RESTORATION OF BIOLOGICAL DIVERSITY

Protection and Conservation

Article 7. Any level of continental, pelagic, coastal or insular biotic organization that is found in national territory and in the waters under its jurisdiction shall be subject to protection and conservation. The conservation of the continental, pelagic, coastal or insular biotic and genetic resources refers to fungi, algae, micro­organisms, animal and vegetable species and lineages, whether native, undomesticated, cultivated, bred or escaped from domestication.

The National Government shall determine the ecosystems and habitats which are subject to in-situ conservation, without prejudice to the dispositions contained in the Decree Law 2811 of 1974, its regulatory decrees and in Law 99 of 1993, subject to the identification of the areas of priority in terms of conserving biodiversity, with the object of establishing a sufficiently representative network of biological diversity and paying equal attention to those areas or places which have a particular cultural, religious or historical significance because they are sacred or holy places according to the cosmogony and traditions of the different ethnic groups in the country.

Article 8. The National System of Units of Conservation is to be created, which defines, amongst others, the following areas and categories for the management of strategic conservation, distinct from those which belong to the System of National Parks, associated with systems of private, collective or institutional property:

m Areas of Integrated Management.

m Buffer zones for the natural national parks.

m Reserves defined by territorial entities.

m Municipal forests.

m Civil society reserves, duly registered.

m Reserves belonging to universities and scientific societies or entities.

m Areas of protective, protective/productive and productive forest reserves.

m Botanical gardens.

m Germplasm banks.

m National monuments.

m National or binational fishing reserves.

m Zoos.

m Biological conservation corridors integrated with private, municipal, etc. reserves.

m Areas of soil conservation.

m Areas of conservation.

m Hydrographic basins in ordination.

m Indigenous territories.

m Reserves in territories of black communities on the territories which have been collectively adjudicated to them according to Law 70 of 1993, which shall be defined in cooperation with the communities.

m Peasant­farmer reserves of law 101 of 1994 (agrarian reform).

Article 9. The National System of Units of Conservation shall work in close coordination with the System of National Parks and shall jointly define with the latter the principles and directives of its actions.

Paragraph: The in-situ units of conservation corresponding to pelagic, insular and coastal biodiversity shall form part of a specific subsystem of protected and coastal and marine areas, which shall, in turn, form part of the Regional Networks of Coastal and Marine areas existing both in the Caribbean and the Pacific.

The Ministry of Defense, through the National Navy, the Colombian Commission of Oceanography and the Ministry of Environment shall support the strengthening of this subsystem and shall establish the mechanisms for integrating the same into the National System of Areas of Protection and Conservation.

Article 10. With the aim of protecting, conserving and utilizing coastal and marine biodiversity in a sustainable way, the Colombian State, through the National Planning Department, the Ministry of Environment, the Ministry of Agriculture through the National Institute of Fishing and Aquaculture, the Colombian Commission of Oceanography of the "Francisco Jose de Caldas" Colombian Institute of Science and Technology (Colciencias) and representatives of the local communities shall integrate the conservation and sustainable utilization of coastal and marine biodiversity into its sectoral and inter-sectoral policies, plans, programs and projects. The said integration shall be reflected in a National Plan for the Integrated Management of the Marine and Coastal Zones of Colombia.

Article 11. For the formulation and execution of measures of conservation and utilization of continental, pelagic, coastal and insular ecosystems and of the live resources contained in them which are located in the frontiers of the country with one or more countries, the Ministry of Foreign Relations, in coordination with the Ministry of Environment and the National Planning Department, shall establish mechanisms for consultation about the formulation, adoption and execution of plans, projects and other bilateral or multilateral types of measures. Said measures shall, in no case, be less stringent than those indicated for the protection of biodiversity in areas subject to national jurisdiction.

Article 12. As a matter of priority the following shall be subject to in-situ protection:

m Species, populations, lineages, communities or ecosystems which are particularly vulnerable or in danger of disappearing or becoming extinct.

m Species or lineages which have a special scientific or economic strategic value, whether immediate or potential.

m Geographical areas that correspond to centres of endemism or high levels of biodiversity.

m Animal or vegetable species or lineages with a particular religious, totemic, cultural or cosmogonic value.

m Sites or areas which have an historic, religious or cosmogonic value whose conservation, apart from the values mentioned, may serve a multiple purpose, fulfilling equally the role of both protecting and conserving biodiversity.

m Agro­ecosystems, species or lineages with high values for use or for options linked to local or national socio­economic and cultural requirements.

m Wild or non­wild species or lineages related to cultivated or domesticated species or lineages and which may be utilized for genetic improvement.

m Natural communities or ecosystems with the capacity to support the environmental supply of goods and services linked to the requirements of the Nation's social and economic production and reproduction.

m Ecosystems or natural communities which, by virtue of their limited surface extension and singularity, are highly vulnerable.

Article 13. As a matter of priority, the following shall be subject to ex- situ conservation:

m Animal and vegetable species and lineages which are particularly vulnerable or in danger of extinction.

m Species, lineages or genetic material which have a special scientific or economic strategic value, whether immediate or potential.

m Species or lineages apt for cultivation, domestication or genetic improvement or which have been the object of improvement, selection, cultivation or domestication together with their genetic material.

m Species or lineages with high values of use or options linked to local or national socio­economic and cultural requirements or to those of international markets.

m Animal or vegetable species or lineages with a particular religious, totemic, cultural or cosmogonic significance.

m Species or lineages which fulfill a critical function in the linking of trophic chains and in the natural control of populations (biological control).

m Species or lineages which have escaped from domestication.

Article 14. The National Government shall take steps towards providing resources and mechanisms necessary for the creation, strengthening, maintenance and functioning of banks of animal and vegetable germplasm, algae, fungi, micro­organisms, genes or cells, as well as experimental stations, zoos, botanical gardens and other types of ex-situ conservation as suitable instruments for the conservation, research, scientific­technical development and utilization of or into biotic and genetic resources.

Article 15. The Ministries of Environment and of Agriculture and Rural Development shall have access to collections of germplasm and reproductive material of a private, institutional or multilateral character, with the object of ensuring the availability of biotic and genetic resources considered to be of a strategic character and vital to national security, as well as information about the same and shall recognise the respective credits where necessary.

Article 16. The National Government will promote and support the conservation and protection of biological and genetic resources which have been the subject of selection or improvement by indigenous and local communities, especially of those at risk of extinction, and which therefore need to be recovered and/or preserved. For that purpose, the Government will establish, in coordination with the communities, the required complementary programmes, activities and agreements for its conservation, through ex-situ or in-situ systems, and will provide the necessary technical and financial resources.

Article 17. The Ministry of Environment shall strengthen and stimulate measures and practices directed towards the protection and conservation of biotic diversity and of genetic resources with the participation and cooperation of the administrative organs of the territorial entities and the organizations of the civil society. For such effects it shall establish and regulate, within a period of six months from the entering into force of the present Law, a viable system of tax, credit and economic stimuli and incentives directed towards the territorial entities, autonomous regional corporations and persons and legally­constituted bodies; at the same time it shall establish, within the same time limit, mechanisms for the supervision and control of the modalities and categories of conservation which derive from such cooperation.

Article 18. When it considers this in the interests of the country, the National Government shall have full powers to declare a partial or total ban on the gathering of general or specific germplasm and on agreements for cooperation or exchange with foreign persons or entities which are related to this matter.

Sustainable Use of Biodiversity

Article 19. The Ministry of Environment, through its institutes of research and in coordination with the National System of Science and Technology, universities and other competent entities, shall coordinate, carry out and supply the resources necessary to identify, compile, evaluate and synthesize the knowledge bases relevant to the biological diversity of the country, represented both by traditional knowledge and the national scientific and technological estate.

Article 20. Based on the identification of the principal processes in the deterioration of ecosystems and biodiversity resources and the factors which occasion them, the Ministry of Environment shall coordinate the design and execution of a strategy and a plan of inter-sectoral and inter-institutional coordination, with the broad participation of the regions and of the civil society, to include as a priority such activities for the prevention and reorientation of non­sustainable processes as have been identified for the control of the deterioration of biodiversity and its restoration.

Article 21. The Ministry of Environment, in coordination with the Ministries of Education and Communication, the Universities, Colciencias and other relevant entities, shall design policies and strategies for formal, informal and popular education which guarantee a broad knowledge among citizens of the value and importance of biodiversity, the cultural heritage associated with the same, the causes which limit it or produce its deterioration, and the possibilities that it represents for the improvement of the conditions of life of the population.

Article 22. The Ministry of Environment, in a period of no more than a year following the entering into force of the present Law, shall revise the existing legislation which, directly or indirectly, contributes to the deterioration of biodiversity and shall complement and regulate the present law in those aspects relative to the protection, sustainable development and immediate recuperation of the existing natural heritage and for the control of those processes which cause harm to it.

Article 23. The Ministry of the Environment, in coordination with the Ministry of Government, indigenous organizations, organizations of black community and associations of peasant­farmers shall formulate a plan for the recuperation of ethnic knowledge related to biodiversity, in order to promote its strengthening and to study the cultural, economic and technical viability of its eventual linking to the productive systems of the country.

Article 24. The Ministry of Environment shall establish mechanisms for the carrying out of the following functions, with relation to research into and the promotion of promissory species:

m Identify, make an inventory of and characterize promissory species of flora and fauna in different regions of the country in coordination with the other research institutes of the Ministry and with universities research centres and indigenous, black and peasant­farmer organizations.

m Identify, on the basis of an analysis of traditional knowledge and of technological experimentation, possible derived uses, artesanal or industrial processes of transformation. In the case that this involves collective knowledge, the identification shall be done in coordination with the respective local communities.

m Coordinate the design of and strategies for the implementation of the corresponding technological packages.

m Carry out studies of regional, national or international marketing.

m Secure the required financial resources and promote large­scale experimentation and the massive implementation of these systems.

Paragraph: The Government shall create in national territory and secure the financial resources needed for the establishment of an ex-situ conservation bank for the wild promissory resources of the nation (micro­organisms, plants and animals).

Article 25. The Steering Committee which is referred to in article 100 of the present law shall carry out the agreements and actions required for the design and putting into action of a program of incentives for the sustainable use of biodiversity.

This Program shall incorporate, as a minimum requirement, incentives to those territorial entities, businesses, community organizations, producers and participants in processes of spontaneous or directed settlement which orient their processes by means of the carrying out of one or more of the following actions:

m Set up centres of primary processing and commercialization based on the utilization of biodiversity resources proper to their region of influence.

m Include scientific and technological development as part of productive, extractive and settlement processes.

m Strengthen the traditional productive systems, particularly those associated with small scale production and develop technological packages based on the sustainable utilization of the resources, species and ecosystems which make up the biodiversity of the region, incorporating sustainable productive systems.

m Protect, conserve and restore strategic ecosystems in their area of jurisdiction or intervention, in accordance with the parameters which the Ministry of Environment shall formulate for such effects.

m Orient extractive and settlement processes with criteria for sustainability and the reduction of environmental impacts.

m Strengthen the permanence and improvement of the quality of life of the producers (peasant farmers and fisherfolk in particular) in their traditional areas of settlement, promoting the improvement of productive systems in order to guarantee their sustainability and the strengthening of marketing systems for their products.

m Financially support or develop lines of soft credit for activities of experimentation, research, production and commercialization, at farm, municipal or departmental level, which are intended to improve and guarantee the sustainability and profitability of productive systems associated with small and medium scale production.

Restoration

Article 26. Quantitative and qualitative inventories of degraded areas and ecosystems, compacted soils, processes of erosion and desertification as well as of species of flora and fauna in grave danger of extinction shall be intensified, widened and reinforced, with the aim of defining, planning and initiating processes of restoration and recuperation of the ecosystems and species and of designing and guaranteeing the mechanisms, financial resources and incentives which ensure this.

Article 27. The Ministry of Environment shall, through the National Environmental System, coordinate: the identification of and priorities for areas of conservation and regeneration throughout the country; the definition and zoning of alternatives for restricted use, including the natural areas and traditional strategic agro­ecosystems; and the formulation and execution of plans and programs of action and management.

Article 27A. The National Government shall give financial and technical support to local communities which undertake projects of alternative development directed towards the prevention and control of the degradation of ecosystems, as well as towards the recuperation of degraded ecosystems.

CHAPTER VI

ON KNOWLEDGE FOR SUSTAINABLE DEVELOPMENT

Research and Scientific-Technical Development

Article 28. The Ministries of Agriculture and Rural Development and of Environment, in coordination with the Colombian Commission of Oceanography as appropriate, shall jointly establish the National Program of Research into Biodiversity, which includes basic and applied research into genetic resources of a continental, coastal, pelagic and insular origin and the execution of plans related to in­situ and ex­situ conservation.

Article 29. The Committee referred to in Article 100 of the present law shall establish joint policies and shall promote basic and applied research into biological diversity and continental, coastal, pelagic and insular genetic resources, for which it will be able to establish cooperation programs with other nations and multilateral and regional organizations, with the full participation of local institutions, scientists, technicians and communities.

Article 30. Colciencias and the Ministries of Environment and of Agriculture and Rural Development shall design and put into operation a National Collections Strategy, intended to: 1) promote inventories, studies and regional and national collections of species of flora, fauna, algae, fungi and micro­organisms through botanical gardens, zoos of native fauna, the preservation of representative nuclei of domesticated creole races, genetic banks and germplasm banks; 2) organize the information produced by the same and design and implement strategies for their management and control.

Article 31. The Ministries of Environment and of Agriculture and Rural Development, in coordination with the National System of Science and Technology, the relevant entities and the local communities, shall promote the identification of technologies suitable for the conservation and sustainable use of continental, coastal, pelagic and insular biodiversity, both within and without the National System of Protected Areas. These technologies shall have to include the management of species or genetic resources of such areas.

Article 32. The Colombian Institute for the Promotion of Higher Education (ICFES), in coordination with the Ministries of Education and of Environment and Colciencias, shall determine policies, mechanisms and incentives for the training and employment of national human resources in the field of scientific and technical development and other forms of knowledge about the present or potential use of continental, coastal, pelagic and insular biotic resources.

Article 33. The Ministry of the Environment, in coordination with the relevant entities and local communities, shall develop strategies for research and technological development for the promotion, strengthening and assessment of traditional agriculture and the creation and transference of technologies which are environmentally and culturally suitable.

Traditional Knowledge

Article 34. The Ministry of Environment, in coordination with the Ministries of Government and of Finance and with the National Planning Department and representatives of indigenous organizations and black and peasant­farmer communities, shall, in a period of no longer than a year from the time the present Law enters into force, design and put into operation a national program of stimuli, incentives, legal support and supervision intended to promote the development of their knowledge, innovation and traditional practices through projects formulated and carried out by the communities. It shall equally protect the right of such communities to decide if they are willing to transfer or share them and to establish the conditions for this.

Article 35. On the basis of the constitutional recognition of cultural diversity, Colciencias, in cooperation with the competent entities and with the indigenous, black and ethnic authorities and community organizations, shall carry out the relevant studies and on the basis of these, the National System of Science and Technology shall be extended to include forms of traditional knowledge as well as scientific knowledge. To this end it shall establish criteria, design and put into action the mechanisms, procedures and systems of control which allow for the presentation, evaluation, validation and follow­up of research programs and projects which are carried out within the parameters of traditional knowledge.

Article 36. The Ministry of Environment may establish, with local communities, agreements for co­administration, for the conservation, development and utilization of ecosystems and biotic resources, including genetic ones, found in indigenous territories, in the territories of black communities and in the territories of other local communities.

Article 37. The National Government, through Colciencias and the Ministry of Environment, shall provide the resources necessary for supporting and strengthening the development of the knowledge and innovative capacity of the local communities.

Article 38. The National Government shall give financial and technical support to projects of alternative development in local communities, in which the recuperation, conservation, improvement and sustainable utilization of the biological and genetic resources shall be given priority.

CHAPTER VII

ON INFORMATION ABOUT AND THE MONITORING OF BIOTIC DIVERSITY AND GENETIC RESOURCES

Article 39. The National System of Environmental Information shall, within a period no longer than six months from the entering into force of the present Law, establish and regulate some principles and a National Program of Information about Biological Diversity and Genetic Resources which shall include, as a minimum requirement, the following aspects:

1. A legally binding ethical mechanism to prevent bio­piracy with regard to information about biodiversity and genetic resources.

2. The regulation of access to information about biological diversity and genetic resources, through classification, in the interest of defending the rights of the country of origin and eventual private or collective rights.

3. The establishment and design of mechanisms to maintain an up­to­date system of information about the state of conservation, use, management and investigation of the biological and genetic resources of the country.

4. The establishment and design of mechanisms to maintain an up­to­date system of information about local and/or introduced agro­ecological technologies which are suitable for the natural and cultural conditions of the country.

5. The exchange of information, from all publicly available sources, about the conservation and sustainable utilization of biological diversity, taking into account the relevant measures for safeguarding national interests in this matter.

6. Measures to guarantee that the exchange of information includes the results of research as well as information about programs of training and study.

7. Measures tending towards the repatriation of information which involves the country's technical, scientific and socio­economic research and specialized, native and traditional knowledge in the cases where this may be necessary.

CHAPTER VIII

ON ACCESS TO BIOTIC AND GENETIC DIVERSITY

Article 40. National or foreign persons or legally­established bodies which desire to gain access to biotic resources, including genetic ones, located within national jurisdiction, shall be subject to this law, to its regulatory decrees and to the Common Andean Regime on Access to Genetic Resources.

Article 41. The Colombian State shall adopt, within a period of a year from the entering into force of the present Law, measures to regulate any activity which implies the exploration and exploitation of the sea bed or of its subsoil or the modification of the configuration of the bottom of the sea in protected coastal and marine areas.

Article 42. The Colombian State, through the Ministry of Environment, the National Institute of Fisheries and Aquaculture, the Colombian Commission of Oceanography, the Ministry of Foreign Commerce and the Ministry of Development shall formulate, within a period of no longer than a year from the coming into force of the present Law, a legal framework for access to and the sustainable use of genetic resources in protected coastal and marine areas.

Article 43. For the formulation and execution of measures for the utilization and conservation of coastal and marine ecosystems and the resources contained in them which are located in the frontier areas between two or more countries, the Colombian State shall establish, through the Ministries of Environment and of Foreign Relations, a mechanism of consultation for the formulation, adoption and execution of plans, projects and other measures of a bilateral or multilateral kind. Such measures shall in no case be less stringent than those set forth to protect coastal and marine biodiversity in areas subject to national jurisdiction.

Article 44. In order to have access to biotic and genetic resources, the applicant must present an application for access before the Competent National Authority, including:

(a) complete and trustworthy information relating to the resource whose access is solicited, including its present and potential uses, its sustainability and the risks which may derive from access;

(b) the identification of the applicant and if necessary, the documents which testify to his legal capacity to contract;

(c) the identification of and other data about the supplier of the genetic resources;

(d) the identification of the person or entity responsible for the project and his work group;

(e) the identification or request for the assignment of the national scientific counterpart which will participate in the research and will be in charge of monitoring the process;

(f) where necessary, the identification of the national, subregional or international person or institution co­responsible for or associated with the project;

(g) the institutional or personal curriculum of the applicant, as well as of those responsible for the project together with proofs of the requisite skills of the members of the work group, including, where applicable, the national, subregional or international partner which is co­responsible;

(h) a justification for the application, indicating all of the possible applications and uses for which the resource is intended and for which it is required;

(i) a description of the object of the application (a reference list of the resources, including, where applicable, the derivatives, synthetic forms, knowledge, innovations and practices);

(j) where this is available, a report about the bio­ecological condition of the populations which are proposed for use (threats, the dynamics of populations, distribution, etc.);

(k) timetable and details indicative of the activities which are intended o be carried out (prospection, collection, extraction, management, research, amongst others), to which shall be added plans for the field mission, indicating the properties, methodologies, strategies and techniques to be used, the quantity of samples to be taken, their biological and physical state, systems of capture, plans for evaluation, storage and preservation of the material, mechanisms of information, systems and equipment to be used, among other data;

(l) the precise location of the areas of access to the resource, as well as the places where the proposed activities will be carried out. In the case of ex-situ genetic resources, all information about the ex-situ centre of conservation will be included.

(m) the initial budget and proof of sufficient solvency through his own resources or other sources of financing;

(n) an indication of the primary destination of the material and its probable subsequent destination.

(o) an indication of the benefits to conservation, whether economic, technical, technological, bio­technological, scientific, cultural, social or of some other kind, which in principle are being offered to the country;

(p) an indication of the guarantees that might be presented to ensure proper compliance with the conditions of the contract in the case that access is granted.

Article 45. If the application is complete, the competent national authority shall begin to process it, shall award it a registration or presentation date, inscribing it in a declaratory character in the public registry which the competent national authority shall keep for this effect and it will open a corresponding file, which may be consulted by any person, except for any parts which may be granted confidentiality, which will figure in a reserved file. If the application is incomplete, it will be returned without delay with an indication as to the missing features, so that it may be completed.

Article 46. The Competent National Authority may celebrate annual contracts with universities and national centres of research which support the execution of diverse projects, in accordance with the procedure foreseen in this law, providing that they do not imply the immediate use, with commercial ends, of the biotic or genetic resources to which access is intended to be given. Without prejudice to that which is foreseen in this law, the competent national authority shall be informed about the initiation and termination of each project and must receive the corresponding reports on the execution of each one of these.

Paragraph: In those cases where a university or centre of research seeks access to a biotic or genetic resource for commercial ends, it must make an application for access, in accordance with the stipulations of articles 44,51 and 52 of the present law.

Article 47. As soon as the Competent National Authority grants permission, a contract must be signed between the parties which shall be formulated in agreement with the criteria and mechanisms established in the general or special regime which applies to it.

Article 48. The Competent National Authority shall confer confidential treatment, at the request of the applicant, only to that information whose divulgation could be subject to unwarranted exploitation by a third party.

For this effect, the applicant shall present a justification for his request, accompanied by a non­confidential resume_ that will form part of the public file. If this is not done, confidentiality will be denied. The confidential aspects shall figure in a reserved file in the custody of the national authority and may not be divulged to third parties, except when a judicial order states the contrary. Confidentiality may not include the following:

m the text of the application;

m the text of the contract;

m the identity of the applicant;

m the supplier of the biotic resources and the knowledge;

m the scientific counterpart;

m the locality, area and resource to which access is required; and

m the methodology to be employed.

Paragraph: In the case of a public entity or of an organization which must be covered by Law 80, as is the case of the National Indigenous Organization, instead of a contract being signed, an inter-institutional agreement shall be made in which the same commitments found in the contracts shall be included. In cases where a third party is involved, the two parties which are signatories to the Agreement shall sign a contract with the third party, following the same procedure established by Article 52.

Article 49. In compliance with the principle enshrined in article 1, number 6 of the present law, two methods are established for the procedures of application for access to biotic resources, including genetic ones: 1) A Special Regime of Access, in which the processing of applications and definition of the conditions of access are in connection with resources that are associated with traditional knowledge. This regime is associated with a sui generis system of intellectual property which is characterized by the avoidance of an individual appropriation of rights over collective knowledge. 2) A General Regime of Access, in which the processing of applications and definitions of the conditions of access are in connection with resources which do not involve traditional knowledge. This regime is associated with individual systems of intellectual property (patents and rights of the vegetal obtainer).

Article 50. The national authority for access to genetic resources shall, under the special regime, process the following applications:

m Applications which are presented by local communities for research into or for the making of inventories about resources in their territories.

m Applications whose specific object is to carry out research into those resources which are known to be associated with collective knowledge.

m Applications for access to resources located in indigenous territories or in the collective territories of black communities which have resulted from the regulation of Law 70 of 1993.

m Applications which have been initially processed under the general regime but are subject to complaints that they would appropriate collective knowledge.

All of the applications which do not fit into the special regime will be processed by the competent national authority responsible for access under the general regime.

Paragraph: The special regime of access shall be regulated within a period of no longer than a year from the entry into force of the present Law together with the development of the collective intellectual property rights which are dealt with in article 67 of this Law by means of a process of consultation and agreement with the full participation of the local communities. The National Government shall guarantee the financial resources and logistic support required for this purpose.

Article 50A. When the application fits into the special regime, in addition to the requisites established in paragraph 44 for access to biotic and genetic resources and their intangible components, it should include the following information, which will be transferred by the competent national authority to the respective organizations of indigenous authorities or black communities so that these, in accordance with the procedures and mechanisms in force in each organization, may transmit and explain it to the communities which are directly involved. On the basis of this information, the community or communities will autonomously decide if it or they accept or not the carrying out of the contract of access:

m the purpose of the mission;

m the work plan and general lines of research;

m potential risks involved in the research (social, economic, cultural and environmental);

m methods of collection and research;

m information about potential commercial and non­commercial values;

m a commitment to recognise citation, authorship and innovation, where applicable; and

m a commitment to leave a copy of all the documents and examples which the community requests.

Article 51. When the general regime is applicable, the contract should contain, as a minimum requisite, the following:

(a) identification of the contracting parties and the scientific counterpart: 1.) the State, through the Competent National Authority, which, as soon as the contract of access is signed, shall exercise the authority of grantor; 2) the applicant for access and when applicable, his partner or national, subregional or international partner, who shall be considered to be the concessionaire as soon as the contract is signed.

(b) identification of the person or community which supplies the resource, annexing to this their consent to allow for the availability of the property which it contains as well as the identification of the mechanisms which guarantee the protection of the cultural integrity and knowledge of the affected community.

(c) the object of the contract, including:

i. the taxonomic identification of the material or its parts, the location of the zone of collection, the name of the collector, the date of collection, the altitude, temperature, the state of the collection, the source of the collection, the situation with regard to its conservation and appropriate ethno­biological observations;

ii. detailed information about the derivative or synthesized resource;

iii. description of the knowledge, innovation or practice associated with the resource, subject to the guarantee of mechanisms for the protection for these;

iv. the volume of samples required;

v. proposed uses (scientific, commercial, for export, etc.);

vi. the place where the activity will be carried out; and

vii. a precise stipulation of the period during which the contact is in force.

(d) An indication of the rights and obligations deriving from the contract, amongst which the following must be evident, amongst others:

i. indication of the benefits of whatever kind that may accrue (economic, technical, technological, biotechnological, scientific, cultural and social) indicating the manner and opportunities for their initial, subsequent and eventual distribution, which may include clauses about their future realization;

ii. a specific indication of the manner and opportunities for participation in the benefits by the suppliers of both tangible and intangible resources, pointing out their characteristics, particularly in the case of indigenous, afro­colombian and peasant­farmer communities;

iii. a determination of the eventual rights over knowledge and of the commercialization of results and conditions for the concession of licenses and sublicenses and certain derivatives of the same;

iv. a commitment by the concessionaire not to grant or transfer the contract without the authorization of the competent authority;

v. a commitment by the concessionaire to consult with and communicate to the grantor information about future research, activities and uses of the genetic resources which are the objects of the contract;

vi. a commitment by the concessionaire to send to the grantor all reports and other publications produced on the basis of the genetic resources conceded together with an indication of the conditions under which the same will be made available;

vii. an indication of the specific manner in which local personnel, in particular from indigenous, afro­colombian and indigenous communities, will be linked to all of the activities derived from access. This may include programs for the transfer of technology, research, education and training, among others;

viii. a commitment that the activities derived from access shall preferably take place in the country and that adequate conditions for an effective transfer of environmentally and culturally friendly technologies shall be created;

ix. a commitment to employ the genetic resources to which access has been granted for adequate environmental and cultural uses. The contract must expressly indicate a refusal to employ or allow the employment of the resources in biological weapons or for practices that are harmful to the environment or to human health; and

x. a commitment to report findings of products which are new or different from those which are the objects of the contract.

(e) an indication of the safeguards and guarantees, for example:

i. commitments to confidentiality, consistent with not divulging to third parties the aspects of the procedure over which the said agreement has been granted;

ii. an obligatory deposit of the genetic resources to which access has been granted in the institution on which the parties agree, including all of the collected samples and associated material, with the express prohibition of representatives of unique samples being removed from the country.

In the case of a sample of vegetable material, the deposit shall be made in the following way:

m If it is a unique example of dead material, it will be deposited in the National Herbarium; if it is live.

m It will be deposited in the Von Humboldt Institute or in the germplasm bank indicated by the authority of this Institute.

m If two examples exist, a second sample will be deposited in the official herbarium and/or the germplasm bank located in the collection zone which has been authorized by the Ministry of Environment for this effect.

iii. The obligation to keep a register of all of the oral, written, photographic or tape­recorded information related to the studies and experiments carried out with such resources.

iv. The establishment of insurance policies corresponding to the stipulations of the contract.

v. The presentation of an environmental impact study, in the case that this is required for the application for access.

vi. With regard to phytogenetic resources, observance of the provisions contained in article 9, 10 and 11 about prospection, collection, maintenance and conservation of samples in the International Code of Conduct for the Collection and Transfer of Vegetable Germplasm adopted by the Conference of the FAO in November, 1993.

(f) An indication of the obligations for monitoring, control and follow­up, such as the following:

i. a description of the technical instruments required for all of the phases previous and subsequent to the research and other activities of access;

ii. mechanisms for supervision, follow­up, participation and evaluation by the Competent National Authority;

iii. mechanisms for monitoring and participation of the scientific counterpart and the supply of regular reports; and

iv. obligation of the contractor to present regular reports of progress and results.

(g) Stipulation for clauses of indemnification for contractual and extra­contractual responsibility, in accordance with article 14.2 of the Agreement on Biological Diversity.

(h) Complementary stipulations, such as:

i. testing periods, timetables and budget;

ii. association with national, subregional or international partners, the Competent National Authority reserving the right to assess the contractor partner.

(i) Indication of the procedure for the solution of conflicts, with the following being expressly stated:

i. "Applicable law": the contracts shall be interpreted, governed by and executed in accordance with that which is set forth in the present Law and, in a supplementary way, by that set forth in the Common Regime on Access, Protection, Use and Conservation of Genetic Resources of the Andean Pact.

ii. "Competent judge": the conflicts will be resolved by a Judge of the Nation or by national arbitration under the conditions agreed on by the parties.

(j) Stipulation for clauses of suspension, cancellation and resolution of the contract

(k) Stipulation for the termination of the contract.

Paragraph: The contracts which are celebrated during the transitory period established in the final provisions of this law and which involve local communities, shall contain an indication of the specific ways in which they will be linked to all of the activities deriving from access. It should cover, amongst other points, programs for transfers of technology, research, education and training, indicating the characteristics which tend to strengthen the capacity and autonomy of the communities, in particular the research techniques which are suitable to their expectations.

Article 52. When the special regime is applicable, the contracts shall be tripartite ones between the State, the communities which supply the biotic resource and the knowledge and the receiver. In these cases, as well as the requisites established by the general regime in article 51, the contract should contain, as minimum requisites, the following:

1. An identification of the three contracting parties: (a) the state as the supplier of the genetic resources; (b) the communities as the suppliers of the biotic resources and knowledge and (c) the receiver.

2. The general obligations of the receiver and the suppliers (country and community (ies).

3. Obligations to report future uses to the suppliers (country and community(ies)).

4. Acceptance that the contract in question is governed by the System of Collective Rights of Intellectual Property.

5. Obligation of the receiver to not transfer the biotic resources, including genetic ones, to third parties.

6. Distribution of benefits, between the receiver and supplier of the biotic resources and knowledge, deriving from access to the resource as well as of the benefits which may subsequently result.

7. The manner and characteristics of the link between the respective communities which are suppliers to the work that is to be carried out, which in every case shall be co­researchers and co­authors, and a guarantee that they will participate until its conclusion, including, if it takes place, in commercialization.

8. The approval of the organizations of indigenous authorities or black communities to which the contracting community belongs, according to the conditions which apply.

9. Mechanisms for overseeing and controlling the development of the contract.

10. A chapter including any definitions which may not have been covered by this Law.

11. A commitment to send periodical reports on the progress of their research, written in a spanish that is clear and understandable for the communities.

12. Procedure for resolving conflicts.

13. Legal norms that must apply.

14. Insurance policies for guarantees.

15. The right of the communities to restrict access should there arise motives to support a cultural objection.

Article 53. Immediately after the signing of the contract, the contract will be entered into the public registry which the Competent National Authority keeps for this effect. From that moment on it is understood that the concession has been granted. The text of the contract and its appendices are to be included in the file.

Article 54. When the access is granted this will be done under conditions mutually agreed on between the Nation, in its condition of grantor, the local communities or other persons or legally­constituted bodies recognised to be the suppliers and the concessionaire, through the provisions found in the regulations of the present Law, in such a way that as to ensure a just and equitable distribution among the parties of the results and information about the research and development, as well as the potential or real benefits deriving from the commercial or other use of the genetic resources.

Article 55. With the registration of the contract, the Competent National Authority shall issue a certificate of access to the resource, which will be delivered to the concessionaire.

Paragraph: The certificate of access does not imply permission for the departure from the country of the biotic or genetic resources which have been authorized. Such permission must be applied for before the respective National Authority. The holder of a certificate of access may only make use, outside the country, of the biotic or genetic material obtained through the said certificate or in the respective contract or agreement after permission for departure from the country has been obtained and legalized. Any utilization of biotic or genetic resources which have not met these two requisites shall be considered as illegal for the effects of the present law.

Article 56. With the certificate of access, the concessionaire shall have access to the biotic resource and must comply with the following conditions:

(a) he may only collect, fish or hunt the authorized species or groups of species.

(b) the activities of exploration, collection, fishing and hunting must not cause an alteration to the environment or to the local communities.

(c) the activities of exploration, collection, fishing and hunting must be carried out with the direct participation of a specialist from the contracting national entity and with native co­researchers from the community involved in the contract mentioned in article 52.

(d) a detailed report about the activity and the destination of the collected samples must be presented, as well as proof that the best duplicate of the collected material has been delivered so that it can be maintained in ex-situ conditions.

Article 57. Every foreign person or legally­recognised body which obtains permission to have access to a genetic resource which belong to the Nation with the aim of scientific research, shall be obliged to give equitable participation in the work team to national researchers selected by the national entity which acts as the counterpart in the contract.

Article 58. The national or foreign persons or legally­recognised bodies and international organisms which have signed a contract of access, shall be under the obligation to:

(a) submit the development of the research to national norms on sanitary, customs and bio­safety control and other norms in force in the areas of biological diversity, genetic resources and conservation of the environment;

(b) guarantee that the National Government has unrestricted access to the knowledge which has been generated and to the information which results from the research;

(c) grant preferential treatment to the country, as the country of origin or the country which supplies biotic resources, including genetic ones, in the utilization of materials obtained from the said resources; and

(d) guarantee the direct participation of the country, as the country of origin or the country which supplies the biotic resources, including genetic ones, in the economic, social and environmental benefits of the products and processes obtained from the use of national genetic resources.

Article 59. The National Government shall regulate the bio­prospection and collection of biotic resources, including genetic ones, in ethnic territories as well as in national areas of conservation, special management and others, in accordance with constitutional precepts, the regulations of the present Law, the sui generis System which regulates the collective rights of intellectual property (article 68 of this Law) and related norms which are in force in the country.

Article 60. The National Government may establish partial or total restrictions or prohibitions on those activities which are directly or indirectly related to access to biotic resources, including genetic ones, in the following cases:

(a) danger of extinction of the species, subspecies, lineages and varieties;

(b) for reasons of endemism or rarity;

(c) in conditions when the structure or functioning of the ecosystems are vulnerable or fragile;

(d) when there are adverse effects upon human health or upon essential elements of the autonomy and cultural identity of the peoples;

(e) undesirable environmental impacts or impacts on urban and rural ecosystems which are difficult to control;

(f) when there is a danger of genetic and/or cultural erosion or the loss of ecosystems, resources and/or the intangible components of them through an unwarranted or uncontrolled collection of germplasm, even when there is a lack of scientific certainty;

(g) non­compliance with the norms on bio­safety and food security; and

(h) the utilization of resources for aims contrary to those established in the International Treaties signed by the country.

Article 60A. The Competent National Authority on Access to Genetic Resources shall revise the contracts, projects for research, bio­prospection and other activities that may imply access, with the aim of ordering the relevant measures for their legalization in accordance with this law and carry out the corresponding measures of vindication.

Article 61. The National Government shall declare illegal the use of genetic resources for the purposes of research, conservation or industrial or commercial application which is not authorized by the respective certificate of access.

Article 62. The National Government shall not recognise rights over genetic resources obtained or utilized in violation of the provisions of this Law. Titles of intellectual or similar property over the said resources or over the products or procedures resulting from access in such conditions shall be invalid.

Article 63. The ex-situ Centres of Conservation shall be subject to that which is stipulated in the present Law, and in the corresponding contracts of access.

These contracts may authorize the signing of material transfer agreements between the centre and a similar one in connection with such resources, providing that they are in harmony with the legal nature of the resource and the conditions laid down in the contract of access and in this Law.

In no case may the similar body exercise intellectual property rights over the resource received.

Article 64. The National Government may deliver genetic resources or biological materials to the International Agriculture Centres, with the exclusive aims of custody or of maintenance. Such resources or materials shall remain under the jurisdiction and control of the country, the centre being considered as a depository.

CHAPTER IX

ON THE PROTECTION OF KNOWLEDGE

Article 65. The National Government recognises and commits itself to the promotion and protection of the rights of local communities to collectively benefit from their traditions and ingenuity and to be compensated for their constant task of conserving and creating useful biotic materials. In this context, it recognises and commits itself to defend the rights of these communities to protect their traditional and collective knowledge, whether by means of sui generis rights of intellectual property or by other mechanisms.

Article 66. The Ministries of Environment and of Government, in coordination with Colciencias and the Colombian Institute of Anthropology shall promote, support and secure financial resources for the carrying out of a Special Program for the Protection of Traditional Knowledge, which will be carried out by the different organizations of indigenous, black and peasant­farmer communities with the aim of proposing and evaluating various alternatives to guarantee the effective protection of traditional knowledge.

Collective Rights of Intellectual Property of the Local Communities

Article 67. Within the framework of the intellectual property rights in force in the country and in accordance with the TRIPS provision of the GATT, a sui generis System of Collective Intellectual Property Rights is established by means of which recognition and protection is given to the rights of the local communities for the knowledge, innovations and practices which have arisen through cumulative processes of conservation and improvement of biodiversity and in which it is not possible to identify an individual directly responsible for their creation; for that reason they transcend the ambit of rights of individual intellectual property such as patents or rights of the vegetal obtainer.

Paragraph 1: To the extent that collective intellectual property rights constitute the acknowledgement of a right acquired ancestrally and not the acquisition of a new right, they cover more than one category (industrial property rights, author's rights, know­how, secrets or others).

Paragraph 2: This System shall be regulated within a period of not more than a year from the entry into force of the present Law and shall be integrated with the special regime of access which is dealt with in Article 50 of the same, through a process of consultation and agreement with the wide participation of local communities. Such regulations shall include:

m The identification of the types of intellectual property rights that are recognised in each case.

m The identification of the requirements and procedures necessary for the recognition of the collective intellectual right and the title to the same.

m The definition of a system of collective registries in accordance with the cultural context in which the knowledge or the innovation has been generated, including the requisites for their being included in the same.

m Criteria and mechanisms for the standardization of procedures.

m The obligations and rights which arise from the entitlement.

m Licenses for the exploitation and commercialization of the protected species, varieties or lineages.

m Identification of the reasons for the denial or cancellation of the right, as well as the causes for the denial or cancellation of the acquired rights to an individual title over the collective knowledge.

The National Government shall guarantee the financial resources and logistical support required for this proposal.

Article 68. The National Government recognises the right belonging to the local communities to exercise their non­consent to the collection of biotic and genetic materials, access to traditional knowledge and accords, plans or projects in their territories, as well as their right to demand a declaration of partial restrictions or bans and the denial of any activity carried on outside their territories, when it is shown that this harms or may harm their natural or cultural heritage.

Individual Intellectual Property Rights

Article 69. The National Government shall establish a System of Registry of genetically­improved lineages obtained in Colombia, as well as of those introduced to the country which have been subject to selection, cross­breeding or improvement. Such a system shall include a process of validation and registry which guarantees equality and equity of rights to the traditional or native communities which have improved the lineages.

Article 70. The National Government shall not recognise any application of individual intellectual property rights (patents or others), filed within or outside the country, with respect to collected samples or any part of them, their properties, activity, derivatives or processes in the following cases:

m which employ the collective knowledge of local groups or communities; and

m which have been acquired without a certificate of access and a license for removal from the country issued by the competent national authority.

Article 70A. The Competent National Authority for Access to Genetic Resources must revise patents and other intellectual property rights registered outside the country on national genetic resources with the aim either of claiming the royalties corresponding to their utilization or of demanding their nullity.

CHAPTER X

ON INTEGRAL BIO­SAFETY

Article 71. Integral bio­safety embraces three interdependent and indissoluble aspects: 1) environmental security; 2) food security and 3) bio­safety (understood in the terms developed on the basis of the First Conference of the Parties to the Convention on Biological Diversity). It is understood that environmental security covers both food security and bio­safety. For the effects of this law they are to be developed independently because of the existence of specific international agreements for each one of these matters.

When dealing with any of these three aspects, the National Government shall examine their implications for the other two connected aspects and take the combination of the three as a fundamental reference for the taking of decisions related to the conservation, use and exploitation of biodiversity.

Article 72. The National Government shall create a Scientific Committee of Integral Bio-safety under the coordination and supervision of the Directive Committee which is referred to in article 97 of the present law, so that a legal framework can be established for the application of the norms on bio­safety related to its three components which allows for the supervising and guaranteeing of integral bio­safety as a commitment by the State to raise and improve the quality of life of all Colombians, establishes strategies for action and advises the Ministries of Environment and of Agriculture and Rural Development and other competent entities in the coordination of its execution.

Paragraph: The Scientific Committee on Integral Bio-safety shall be made up of national researchers from the principal universities and research institutions in the various disciplines involved in the three components of integral bio­safety and by representatives of the Ministries of Environment, Agriculture and Rural Development, of Foreign Commerce, the Office for Attention to and Prevention of Disasters of the Presidency of the Republic and other competent authorities.

Article 73. The National Fund for the Environment shall supply and, where necessary, procure resources for the permanent functioning of the Committee as well as for the support of the execution of the programs which are identified in the strategies. These resources should provide all of the technical instruments as well as the modern systems of communication and information which are required.

Article 74. The National Government shall give autonomy to the Scientific Committee on Bio­safety so that it can fix priorities for the needs for research in integral bio­safety.

Environmental and Food Security

Article 75. The National Government shall promote programs oriented towards the improvement of the methods of production, conservation and distribution of foods with the full utilization of national and international technical and scientific knowledge which is environmentally and culturally clean and secure.

Article 76. The National Government shall work towards perfecting the present agrarian regime so that an exploitation and utilization best adjusted to the potential and limits of natural capacity is achieved.

Article 77. The National Government shall promote the incorporation of wild biotic resources into local and regional economies and into the national economy, as well as on the level of the international market, watching over the perpetuation of such resources.

Article 78. The Government shall promote and support strategies for production in which farmers and research centres directly participate and which involve: 1) the recovery of local domesticated or cultivated genetic lineages 2) the propagation of these lineages in ex-situ genetic banks 3) the classification and evaluation of the said lineages 4) eventual genetic improvement and the production of improved seeds on the basis of these lineages and 5) the divulgation of the results with the aim of generating new production strategies.

Article 79. The Government, through the National System of Science and Technology, shall gives incentives to and financially support the creation of in situ areas of conservation (in particular, agro­ecosystems), seed banks and micro­organisms and wild animal reserves through community programs which help to prevent the loss of genetic variability during the period of transition which runs from the rescue stage to the stage of full use of local varieties, particularly in those areas where local cultivated and zoological varieties are affected by the introduction of other varieties or the substitution of local lineages.

Article 80. The Government shall promote and support programs in marginal zones for a rational form of management of wild fauna and flora which avoids alterations to the ecological balance of these areas and for the production of goods and services for the local populations.

Article 81. The Colombian Government shall NOT grant patents or other individual intellectual property rights on cultivated species or ones improved on breeding farms which are used as an alimentary or medicinal base or have a cultural use because it considers that this constitutes a serious threat to the environmental security of crops or animal races and that it represents a clear threat to national integral bio­safety.

Paragraph: In case of reasonable doubts about the taxonomical hierarchy of a species, the principle of prevention shall be applied.

Article 82. The Government shall regulate imports and exports of foods in such a way that they do not negatively effect national systems of production, employing a price policy that stimulates the national producer without doing harm to the interests of the consumer.

Article 83. The sale of bio­technological food products, whether of national or foreign origin, is prohibited when these represent a danger for the integrity of traditional or local agricultural systems.

Biosafety and Bio­ethics

Article 84. The Ministries of Environment, Agriculture and Rural Development shall define, in a period of no longer than six months from the entry into force of the present law, the national regulation of integral bio­safety matters, without prejudice to the provisions which, for this effect, stem from the Convention on Biological Diversity and the Cartagena Accord, and taking into account the ethical implications which may derive from the application and use of the processes and products of bio­technology.

Paragraph: The Government shall promote and strengthen the financial, technical and operative capacity of the national public entities whose mission and objectives are related to the control, supervision, evaluation and ethical implications concerning the security of bio­technological products and processes.

Article 85. The Ministries of Agriculture and Rural Development and of Environment shall regulate and supervise the imports and exports of bio­products in such a way that they do not negatively affect the different systems of national production.

Article 86. The Government shall regulate, within a period of six months from the entry into force of the present law, the transit through or temporary presence within the country of genetic and transgenic materials which come from other nations and have a foreign destination, paying particular attention to national integral bio­safety.

Article 87. In accordance with Article 9, paragraph 3 of the Convention on Biological Diversity, Prior Informed Consent is established as an obligatory requisite for activities of manipulation, management, domestic utilization, release and/or international transference of live organisms, whether modified or not.

Article 88. The entrance of a live organism which has been genetically modified shall be rigorously restricted with the aim of protecting the health of the population and of the environment and therefore, must be carried out on the basis of the following requisites:

1. Prior-founded Consent.

2. Application for permission.

3. Agreement­permission, when applicable, in accordance with the present law.

4. Decision of the Competent National Authority on Bio­safety.

For an application for permission for the entrance of a live organism modified as the result of bio­technology, the interested country or exporting company must supply the Competent National Authority on Bio­safety with all of the relevant information about the product.

The information should include, among other things, the following:

1. Evaluation of the environmental, social, cultural and economic risks and risks to public health.

2. A complete description of the characteristics of the organism in question, of the biological cycle of the guest and the host.

3. All of the required scientific background, whether through publications or through research reports.

4. Information about previous releases of the organism.

5. Regulations about its safe management that apply the exporting country and in ecosystems similar to that in which it is hoped to introduce the organism.

6. Information about the conditions of release, as well as about the complete procedure for managing risks.

7. The Competent National Authority shall ensure that each person or legally­established body, whether national or resident in the country, which is going to export a modified live organism resulting from the application of bio­technology, notifies the competent authority of the receiving country about it.

Paragraph: The principle of familiarity is not acceptable in the evaluation of environmental risks and impacts.

Article 89. When there occur acts or indications which pose a grave or imminent threat to integral bio­safety, the Competent National Authority on Bio­safety, in coordination with the Office for the Prevention of Disasters of the Presidency, applying the precautionary principle, shall establish mechanisms to eliminate or eradicate the causes of the risk or harm to the heritage.

Article 89A. When damages produced to one of the components of integral bio­safety occur as a result of bio­technology, the Competent National Authority shall claim the respective indemnifications and reparations both from the entity which has carried out the research and manipulations which are the direct causes of the damages as well as from the company which has promoted the same, applying article 14.2 of the Convention on Biological Diversity.

Article 90. The Government shall support and facilitate the development, establishment and application of an international legally binding protocol on bio­safety and bio­ethics which regulates the use, in environmentally healthy and secure conditions, of the products and processes which imply the utilization of technologies of nucleic acids as well as of the management, manipulation, use and release into the environment of live organisms which have been modified as a result of bio­technological processes.

CHAPTER XI

ON THE DEVELOPMENT AND TRANSFER OF BIO­TECHNOLOGY

Article 91. The National Government shall promote and support the development of national bio­technologies based upon the use and improvement of native species, lineages and varieties and shall give priority to traditional uses and practices in accordance with the particular aspirations for life within the territories of the local communities.

Article 92. The Government shall promote the rescue and evaluation of traditional and local bio­technologies.

Article 93. The State shall permit the evaluation within the country, of foreign bio­technologies always provided that these are governed by the norms of integral bio­safety and by the principles of bio­ethics stipulated in the present law and its subsequent regulations, and that the foreign or multinational company responsible integrally assumes responsibility for any damage that they may cause to health, the environment or to local cultures in the present or in the future.

Article 94. The Colombian State shall create mechanisms to ensure and facilitate access for national researchers to technologies relevant to the conservation and sustainable utilization of biological diversity or which utilize genetic resources which do not cause harm to the natural and cultural environment of the country.

Article 95. The National Government shall create mechanisms to facilitate the transference of environmentally and culturally safe bio­technologies.

Article 96. The National Government shall establish the relevant legislative, administrative or political measures to ensure that access to and the transference of foreign bio­technologies, including any technology protected by patents and other intellectual property rights, take place in mutually agreed conditions, and when necessary, with adjustments to comply with international law.

Article 97. The National Government shall guarantee that access to and transference of technologies are done in fair conditions and in the most favourable terms for the country, including preferential and concessionary conditions (Article 16 of the Convention on Biological Diversity).

Article 98. In the case of technologies subject to patents and other intellectual property rights, the National Government shall guarantee that access and transference are done in conditions which take into account the adequate and effective protection of intellectual property rights and are compatible with them.

Article 99. The Government shall establish the Competent National Authority on National Food Security, responsible for coordinating, guiding and guaranteeing the exercise of the right of citizens to food, as laid down in Article 11.2 of the Charter of Human Rights of the United Nations, which has been ratified by Colombia. This authority shall be under the coordination of Inter-sectoral Technical Committee on Biological Diversity.

CHAPTER XII

ON THE INSTITUTIONAL FRAMEWORK

Article 100. The Directive Committee of the National Strategy on Biodiversity, or, in its absence, a national inter-sectoral coordination body at the highest level, made up of representatives of the public sector, professional organizations, NGOs and organizations of indigenous communities which have been authorized to coordinate national policy on matters of biodiversity and bio­safety shall be the maximum authority for the application of this law.

The advisory body of this Committee shall equally be inter-sectoral and shall be made up of State officials, representatives of research institutes and centres, the academic sector, authorities of community organizations, NGOs, etc. of the National Environmental Systems. This advisory body shall support the Committee in matters related to the traditional and techno­scientific forms of knowledge and innovation, as well as in matters related to the protection, conservation and management of biodiversity and bio­technology.

Article 101. The advisory body of the Committee referred to in the previous article shall have the following functions:

(a) To recommend policies and mechanisms for coordination between the entities and organizations which are competent in matters of biological diversity, genetic resources and bio­safety.

(b) To provide the assistance required by the Committee in matters related to the promotion of biodiversity, integral bio­security and related cultural matters.

(c) To promote different forms of knowledge about such matters as the conservation, development and sustainable use of biological diversity and genetic resources.

(d) To watch over the observance of the principles that govern the present law.

(e) To coordinate the periodic monitoring of the ecosystems, species or natural communities that require special protection.

(f) All other functions that may be assigned to it under the present law.

Article 102. By virtue of being an activity that requires an inter-sectoral and interdisciplinary approach, the competent national authorities in any of the specific areas related to the promotion of biodiversity and bio­safety must carry out their functions in close coordination with the other authorities that deal with this matter. By the same token it should fully inform and make consultations about its decisions and policies with civil society and the organizations of local communities, as established by Article 76 of law 99 of 1993.

CHAPTER XIII

ON THE REQUIREMENTS, FORMS OF OPERATION AND CHARACTERISTICS OF THE PROCESSES OF NATIONAL NEGOTIATION ON GENETIC RESOURCES.

Article 103. The Government shall utilize fundamental criteria for the forms of joint venture or similar mechanisms of negotiation or association for the development, promotion and commercial use of certain genetic resources which are a national strategic priority.

Article 104. The State will endeavour to strengthen institutions and access to information, education and training in processes of negotiation for firms of association (national, joint, international) in matters relating to the use, commercialization and processing of genetic resources.

Article 105. The Ministries of Foreign Relations, Foreign Commerce, Government and Environment, on the basis of a prospective study of the international commercial and political context, shall design and put into action a strategy for the strengthening of their capacity for negotiation in matters of biodiversity, both among the national institutions and actors and with regard to foreign countries.

CHAPTER XIV

ON THE REGIME OF SANCTIONS

Article 106. The competent Authority shall impose the following preventive measures and sanctions, through resolutions and according to the gravity of the violation, upon the infractor of the norms in force on the protection, use, promotion and negotiation of biological diversity, genetic resources, bio­safety and food security:

(a) Preventive measures

m Written warning;

m Preventive confiscation of the resource which has been subject to infraction, as well as the materials, mechanisms and equipment associated with the illegal act.

(b) Punitive Measures

m Daily fines up to an amount equivalent to 300 minimum monthly salaries.

m Suspension of the permission or license for access to or use of the resource.

m Revocation or expiration of the permission for access.

m Definitive confiscation of the resource, the equipment, materials and other infrastructure employed to carry out the illegal act.

Paragraph: The sanctions established by the present article will be applied without prejudice to the exercise of the civil and penal actions which may arise.

Article 107. As well as being subject to the corresponding penal and financial sanctions, public officials who, through their actions, omissions or their unauthorized activities, bring about the deterioration of the national biotic, genetic and cultural heritage, shall be considered guilty of bad conduct.

Article 108. The following actions cause harm to the biotic, genetic and cultural heritage of the nation or to its integral security and shall therefore be considered as an ecological crime and so specified in the National Penal Regime:

Any action:

m AGAINST NATIONAL SOVEREIGNTY;

m AGAINST ENVIRONMENTAL SECURITY;

m AGAINST FOOD SECURITY;

m AGAINST BIO­SAFETY;

m AGAINST THE INTEGRAL RIGHTS OF THE LOCAL COMMUNITIES; and

m AGAINST INTELLECTUAL PROPERTY RIGHTS.