3 MATERIALES Y MÉTODOS
3.8 Análisis estadístico
understanding of what the country has to offer in terms of genetic resources.
Main accomplishments: This strategy has achieved
more tangible results. The Humboldt Institute has
a Program with the main task of undertaking the country’s biological inventory, which has substantially advanced implementation the strategy’s goals. • Recover, protect, and publicize traditional knowl-
edge. This is a key policy strategy related to , even though the strategy’s scope goes beyond genetic resources. On the specific topic of access, the goal is to establish and implement norms and mechanisms for the protection of knowledge, wis- dom, innovations, and traditional practices.
Main accomplishments: The debate over the way to
protect and recover traditional knowledge is highly controversial, and substantial discussions are still re- quired to reach a consensus at the national level. This is particularly true for knowledge related to genetic resources. The Humboldt Institute carried out a study specifically related to the protection of traditional knowledge in the context of , and outlined a pro- posal on the topic: “Protección al conocimiento tradi- cional. Elementos conceptuales para una propuesta de reglamentación—El caso de Colombia” (Protection of traditional knowledge. Conceptual elements for a norm proposal—Colombia’s case). This proposal provides a relevant first step in continuing the national debate, before entering negotiations at the Andean level.7
• Promote ex situ conservation. This strategy is closely related to the topic of . Its goals in- clude completing the inventory of existing taxa in ex situ collections; selectively incorporating into ex situ collections strategic components of biodiversity depending on their vulnerability or their cultural, economic, ecological or evolution- ary importance; strengthening of ex situ conserva- tion banks; strengthening human resources for ex
situ conservation and related research; creating a national information system of ex situ collections and; obtaining verifiable economic, social and eco- logical benefits from ex situ conservation banks. The development of this strategy will significantly affect the way access to genetic resources occurs in Colombia.
Main accomplishments: There are substantial results
in the implementation of this strategy nationwide, mainly in terms of information management. There are still insufficient efforts to incorporate species of particular strategic importance in ex situ collections.
Legislation on Access to Genetic
Resources
Identification of Relevant Access Laws
Although the most comprehensive piece of legislation for Colombia regarding is Decision , there are several other key laws and statutes related to genetic re- sources. Table includes the names of the pertinent ones in chronological order. The more relevant aspects of laws and
statutes and their relationship to will be highlighted
in this section. Additional information on how these laws and decrees relate to genetic resources may be obtained from Instituto Humboldt (P a).
The is considered the central piece of legislation regarding biodiversity in Colombia. One of the objectives of the is to promote the fair and equitable sharing of
benefits arising out of the utilization of genetic resources. The also encourages the transfer of relevant technolo- gies, through appropriate funding, taking into account all rights over those resources and technologies (/ ). Additionally, the recognizes the sovereign rights of nations over their natural resources and their authority to determine access to genetic resources. It also establishes that each contracting party should endeavor to create conditions to facilitate such access by other con- tracting parties and should not impose restrictions that run counter to the intentions of the Convention. It further states that when access is granted it should be given under mutually agreed upon terms. Additionally, it indicates that each contracting party shall endeavor to carry out scientific research based on genetic resources provided by another party with the providing party’s full participation, and, if possible, to conduct that research in the country of origin. Finally, it establishes that each party should take legisla- tive, administrative, or policy measures, as appropriate, with the aim of sharing in a fair and equitable way the results of research and development. The agreement also requires that benefits arising from the commercial or other utilization of genetic resources shall be shared with the contracting party providing such resources and such sharing should be upon mutually agreed terms. The thus sets a comprehensive policy framework for and requires countries to take the appropriate measures to facilitate it.
Of the national legislation summarized in Table , it is worth highlighting the contents of the Colombian Political Constitution and of Law of . The Political Constitution establishes in Article , second paragraph, that the State will regulate the entry and exit of genetic re- sources and their use according to national interests. Since the Colombian State is sovereign over its genetic resources, it is entitled to legislate their conservation, use, import, export, and any other activity related to this resource.
Law of also creates the and organizes the National Environmental System. Two relevant provisions regarding that develop the mandate of the Constitution are given to the . Article , numeral , gives the the function of regulating the securing, use, management, research, import, export, distribution, and commerce of species and genetic lineages of fauna and flora; regulat- ing import/export and commerce of such genetic material; establishing the mechanisms and procedures of command and control; and arranging for the necessary claim of pay- ments or acknowledgements of the rights or privileges be- stowed on the Nation due to the use of genetic material. In numeral of the same article, law / indicates that the must ensure that the study, exploitation, and research, both national and foreign, relating to Colombia’s natural resources respects national sovereignty and the rights of the Colombian Nation over its genetic resources. This law gave the major responsibilities regarding before the adoption of Decision .
Table . Laws and norms related to genetic resources
Norm Title
Decree Law of Natural Resources Code Decree of Regulates the Natural Resources
Code (Decree /)
Decree of Regulates the Natural Resources Code (Decree /) regarding wild fauna.
Law of Agreement
Decree of Regulates the Natural Resources Code (Decree /) regarding issues of natural protected areas (Integrated management districts). Political Constitution
of
Law of Convention No. on Indigenous people and tribes in independent countries
Law of Develops the transitory article of the Constitution (black communities)
Law of Creates the and organizes the National Environmental System Decision of Common Regime for the
Protection of Plant Variety Breeders’ Rights.
Law of Convention on Biological Diversity Decree of Regulates the law of Afro-
Colombian communities
Decree of Creates the National Commission of Indigenous Territories and the permanent harmonization table with Indigenous Organizations. Decision of Common Regime on Access to
Genetic Resources
Law of For the protection of Colombian flora, and regulates botanical gardens.
Decree of Determines the National
Competent Authority in the matter of access to genetic resources. Resolution of By which some functions of
Decision are delegated and the internal procedures for access to genetic resources and their derivatives requests are set. Decree of Regulates scientific research about
biological diversity.
Decision of Common Regime on Industrial Property
Common Regime on Access to Genetic Resources— Decision 391
Decision is a regional regime that was negotiated and adopted in under the Cartagena Agreement of the Andean Community. Decisions adopted under the Cartagena Agreement are binding, and once approved, they are automatically integrated into national legislation for their execution, without requiring any approval by the legislative apparatus of the member states (// ). Therefore, their application does not necessarily require the establishment of a new law, and can be imple- mented with only a few additional dispositions (C et al. ). Additionally, it is commonly understood as a general norm that establishes minimal rules applicable to all member states, which countries can individually de- cide to develop further on their own or apply immediately (// ). Therefore, this agreement is bind- ing for all countries of the Andean Community: Bolivia, Colombia, Ecuador, Peru, and Venezuela.
By the end of , the Andean Community ap- proved Decision regarding a Common Regime for the Protection of Plant Variety Breeders’ Rights. This decision establishes that the member countries would adopt “a com- mon regime on biogenetic resources, biosafety measures for the Sub region, in concordance with the Convention on Biological Diversity”. After the approval of Decision , the first steps for the development of an access decision were initiated. Decision was adopted on July , and became officially binding on July , when it was published in the Official Gazette of the Cartagena Agreement. It is considered a major development of the on . The following three major characteristics of this Decision make it noteworthy:
• Decision regulates the access8 to genetic re-
sources9 as well as to their derivative products10.
Therefore it is not limited to genetic resources per
se, but also includes other molecules of biological origin produced by living beings, with a broader scope than the specific provisions of the . • The agreement explicitly recognizes the importance
of knowledge associated with the genetic resources by considering it a central part of access under the name “intangible component”.11 Here again it goes
beyond the original scope of the .
• The Decision makes a reiterative separation be- tween biological resources on one hand and the genetic resources and their derivative products on the other, by indicating that the former contains the latter.
The following are the objectives and goals of Decision :
• Provide conditions for a fair and equitable partici- pation in the benefits derived from access. • Establish the basis for the recognition and valuation
of genetic resources, their derivative products, and
their intangible associated components, especially when referring to indigenous, Afro-Colombian, and local communities.
• Promote the conservation of biological diversity and the sustainable use of biological resources that contain genetic resources.
• Promote the consolidation and development of scientific, technological, and technical capacities at the local, national, and subregional levels. • Strengthen the negotiating capacity of member
countries.
The Decision indicates the minimal requirements that must be taken into account when making an access application. It also stipulates the need to establish a con- tract agreement between those interested in the access activities and the National Competent Authority () in order to guarantee the objectives of the decision. This contract should take into account the rights and interests of the providers of the genetic resources and its derivative products, the providers of the biological resources that contain them, and the providers of intangible components, if applicable (P a). The principal contract should be supplemented with an appendix when access to genetic resources or derivative products with an intangible com- ponent are requested. This appendix should be signed by the provider of the intangible component and the applicant to access, even though it may also be signed by the (P a). Additionally, the Decision includes the need for an accessory contract to protect the rights of the owners of the biological resources and of the landowners where the resources are located. These aspects will be expanded upon later.
Legal Developments of Decision 391 and Norms that Contribute to its Implementation
In Colombia two main additional legal dispositions were adopted in order to facilitate the implementation of Decision (Table ):
• Decision establishes that every country must determine an for purposes. This author- ity is a public entity authorized to provide genetic resources or their derivative products, to subscribe to and oversee the contracts on , and to comply with the provisions of the decision. Decree of determined that the is the , thus empowering the Ministry as the unique authority in all access issues in Colombia.12
• Resolution of clarifies the internal pro- cedures to be undertaken by the to process ac- cess applications. These procedures will be detailed later.
Another legal development, adopted by Decree of that regulates scientific research relating to bio- diversity, contributes to the implementation of Decision and was partially developed with this intent.13 This
Decree basically simplifies the permits, authorizations and
safe conducts that were required to undertake scientific research regarding biological diversity in Colombia by establishing a unique “study permit with the purpose of scientific research”14. This permit is required for activi-
ties of collection, recollection, capture, hunting, fishing, manipulation of the biological resources, and their mobili- zation through the national territory. It is worth noting that the decree explicitly excludes issues pertaining to health and agriculture except when these involve specimens or samples of wild fauna or flora (Article ). It also indicates that foreigners willing to undertake scientific research in Colombia must present a Colombian co-researcher(s) to participate in the research activities. The decree has spe- cific provisions related to access to genetic resources, and the following should be highlighted:
• Any scientific research which requires obtaining and utilizing genetic resources, their derivative products, or their intangible components is subject to the decree and to all other norms pertaining to access to genetic resources (Article ).
• The granting of a study permit by an environmental authority does not require the to authorize ac- cess to genetic resources.
The Autonomous Regional Corporations (i.e., regional environmental agencies) thus may have an indirect role in the application of Decision when they grant a study permit that may involve with respect to the activities regulated by Decree of or any other activity that the access project may require that may lie within the Corporation’s functions. However, the Regional Corporations do not have any major authority, nor do they take part in the evaluation of or the granting of access contracts. Nevertheless, the may consult the Regional Corporations if it considers this useful and may even in- volve them in follow up and oversight activities of a given contract, through specific agreements.
No future legal reforms to implement the Decision have been proposed to date. Still required is the development of policies (as will be analyzed below) and of additional legislation for the protection of traditional knowledge. In fact, Decision establishes that a special regime or harmonization norm should be established for the protec- tion of knowledge, innovations, and traditional practices of indigenous, Afro-Colombian, and local communities.
Ex Situ Conservation Entities, Industries, and Activities Regulated by Decision 391
Ex situ conservation organizations
The Common Regime on clearly indicates that it is applicable to those countries that are countries of origin of genetic resources, their derivative products, and their intangible components. Additionally, access is defined as the obtainment and utilization of genetic resources in ex
situ or in situ conditions, their derivatives, and, if it is the case, their intangible components, with the purpose of research, bioprospecting, conservation, industrial applica-
tion or commercial use, among other activities. Finally, the Decision explicitly indicates that ex situ conservation cen- ters or other entities that undertake activities relating or their derivative products or, if applicable, their intangible components associated must sign access contracts.
Therefore, the Decision explicitly includes all genetic resources and derivative products under ex situ conditions, thus including botanical collections, seed banks, zoos, breeding centers, botanical gardens, aquariums, tissue banks, collections in natural history museums, herbaria,
in vitro collections, and any other instance, center, or col- lection that may possess genetic resources or derivative products that will be used for purposes. This implies that Decision is also applicable to The International Center for Tropical Agriculture, a research institution un- der the Consultative Group on International Agricultural Research located in Colombia.
Industries and activities regulated by Decision 391
The access definition of Decision is very broad. It refers to access as related to the intent of those who wish to use the genetic resources, derivative product, or intan- gible component, in specifying that the purpose must be for “research, bioprospecting, conservation, industrial ap- plication, or commercial profit, among others” (Article , Decision ). Therefore, a wide range of activities may lie within this definition, but exactly which activities should be regulated under the Decision is still unclear.
The Decision also makes a clear distinction between genetic resources and derivative products, and biological resources, thus limiting the scope of the Decision by ex- cluding biological resources that are not used or acquired with the intent of access to genetic resources or their de- rivative products. This exclusion is nonetheless difficult to understand as all biological material contains genetic material or derivative products.
However difficult the interpretation of the Decision may be regarding what activities are covered, it is neces- sary to keep in mind both the intention of the Regime and the practical aspects of its application. It would be a mistake to require access contracts for a wide range of activities that require the use of biological material, un- der the premise that biological materials contain genetic material.
An example to illustrate this point, even though con- troversial, is the exchange of botanical collections for taxonomic identification. Botanical samples not intended for purposes are frequently sent to experts for the purpose of taxonomic identification. Nevertheless, an may believe that since a biological resource contain- ing genetic resources is exchanged, an access contract is required. This is even more of an issue if the sample is exported to a foreign collection. The is correct that access can occur, but it is mistaken in requiring an access contract, because the intent is taxonomic identification and not access to genetic resources. Nevertheless, the access definition of Decision allows for this ample interpretation of the norm.
Even more difficulties arise when other types of activi-
ties are analyzed. For example should biological resources from which botanical extracts are obtained, purified, or processed for commercial purposes be included? Under a strict interpretation of Decision they can be included, but it is unclear whether this is the right policy choice.
The activities and industries that should definitely be covered by Decision are thus difficult to identify. Therefore it is the duty of each of the countries of the Andean Community to reflect upon this complex subject in order to determine the appropriate interpretation of the Decision. Ideally, this interpretation should be agreed upon by all countries, and the appropriate forum to discuss this topic would be the Andean Committee on Access to Genetic Resources, which was created by Decision . In fact, within the Andean Regional Biodiversity Strategy, such discussions have already begun at a very general level.
In Colombia, the Humboldt Institute has begun to analyze the subject. One of its publications regarding Colombian legislation states:
It is important to acknowledge that there are practical dif- ferences between using biological resources and access- ing genetic resources, because the access to a biological resource implies the physical action of collecting, taking, hunting or cultivating. Biological resources can be used and profited as a whole. On the contrary, to access a genetic resource, the biological resource must undergo a transformation process that allows separating and isolating the genetic resources or derivative products,