Chile: Early Attempts to Develop Access and Benefi t-Sharing Regulations

10 Chile: Early Attempts to Develop Access and Benefit-Sharing Regulations Luis Flores-Mimiça and Dominique Hervé-Espejo Since the entry into force of the Convention on Biological Diversity (), many countries have begun to develop national biodiversity strategies and access regulations pursuant to the requirements in its Articles  and , specifically to regulate the access to genetic resources within their national jurisdiction. Their experience is very valuable for those countries that are just about to initiate the process. As a part of a comparative study of the policies and laws in charge of regulating the access and the exchange of genetic resources among Pacific Rim Countries, the main objective of this document is to review and analyze the situation of Chile on this matter. As will be explained in this document, Chile does not have any kind of specific framework for regulating access and benefit-sharing issues, nor is it engaged in a serious process for developing such laws or policies. In , shortly after Chile’s ratification of the , there was a brief initiative to regulate this matter, prompted by the political impact that some bioprospecting projects had on the environmental authorities of the time. In the long run, there were no significant results from this initiative. This failure was due, in considerable part, to the complexity of the subject and the many difficulties that the development and implementation of such an initiative has, but overall it was the result of a lack of political will among legislative and higher-ranked administrative authorities to consider this a matter of importance for the country. Given the total lack of policies and legislation on the matter, in order to make an adequate analysis of the current situation in Chile in relation to the actual exchange, handling, and utilization of genetic resources and its eventual regulation by State authorities, throughout this paper the main related principles, rules, and concepts of the  will be used as a reference and as a means of confronting Chilean reality. With that perspective, the paper will present an overview of the actual institutional management of genetic resources in Chile, analyzing the questions of property, access, intellectual property rights, and bioprospecting agreements, concluding with some remarks about the process of developing a regulatory framework on access and benefit sharing. Analysis of the Legal, Institutional, and Political Situation of Genetic Resources in Chile The international legal framework of access and benefit sharing established by the  can give countries the opportunity to make substantial profits from the sustainable utilization of their own genetic resources, through a fair and equitable sharing of the benefits arising out of the use of such resources. Nevertheless, national governments must know how to take advantage of this opportunity, es- tablishing some type of legislation to regulate the access and benefit sharing of their own genetic resources and, equally important, developing political awareness, institutional strategies, procedures, and capacities to implement these provisions. The regulatory system created by the  should also be seen as a very useful mechanism of negotiation for  A B  S  B those countries that are providers of genetic resources, although it has to be adapted to local circumstances and to national interests and priorities in order to achieve its goals. The manner in which countries approach this matter and finally enact a legal regime of access to their genetic resources will necessarily reflect the status of their economic, environmental, and technological development, as well as their legal, institutional, economic, and cultural situation. There is no ideal model to be followed, because each country has its own reality and is placed in a very singular position. Thus, there are many alternatives by which the mechanism of access and benefit sharing formulated by the  can be set into practice in the particular scope of national legislation. However, according to the regulatory experience that already exists, from a formal point of view it would be possible to identify three basic ways to deal with the subject ( ): • The Legal Approach, through measures that involve the development, implementation, and enforcement of legal, administrative, and policy provisions and frameworks. National governments are able to exert their authority through a variety of alternatives: taking advantage of general laws on environment; using framework laws; developing specific laws to regulate access and distribution of benefits or regulating genetic resources as a singular component of legislation of broader range; and adapting or modifying existing laws and regulations, etc. • The Contractual Approach, by means of private arrangements or agreements directly made between the suppliers of genetic resources and those interested in using them. These private arrangements or contracts are essentially legally enforceable agreements between two or more parties, consisting of exchanges of negotiated promises or actions, set under the rules of national or international private law, generally made between stakeholders considering mutual benefits on access and distribution. There are multiple contractual alternatives for the exchange of genetic resources, from simple contracts to letters of understanding, licensing agreements, and many others. In the case of the exchange of biological samples, such agreements are usually known as Material Transfer Agreements (s). These s were the first formula through which the question of access to genetic resources and benefit sharing was ever approached. • The Voluntary Approach, by means of codes of conduct or voluntary guidelines, generally elaborated as the result of a consensus among stakeholders or developed by someone with such authority. These regulatory instruments are not legally enforceable and their fulfillment and utility depend on the good will of those who are parties to the matter. These different approaches can have advantages and  disadvantages that will, of course, be determined by the particular circumstances of each country. They differ from each other in a series of formal aspects that are applicable to many different situations. However, all these formal approaches can coexist without problems within the same internal legal framework. For example, a law that regulates access to genetic resources (the legal approach) can clearly establish that certain matters should be directly negotiated between the stakeholders, according to the rules of the private law (the contractual approach) but considering the guidelines designed by the competent authority (the voluntary approach). So far, in all those countries in which the system of access and benefit sharing established by  has not yet been implemented, private agreements have been the main mechanism to regulate access to genetic resources and the way benefits are shared (the contractual approach). Such is the current situation in Chile, where political authorities have not yet been able to begin a serious legislative process for the implementation and enforcement of the rules and principles of the , and the administrative authorities do not have a legal framework nor any specific provision to enable them to regulate the exchange and utilization of genetic resources. The Political and Legislative Management of Genetic Resources First of all, it is very important to point out that in Chile there are many endemic species (as many in flora and fauna as in microorganisms) that are broadly distributed in the national territory. A considerable number of these species have not yet been properly studied and remains almost unknown (U  C ). In addition, in Chile there exists a considerable scientific and technological capacity to carry out projects of research and development in the area of biotechnology, which adds important value to Chilean genetic resources. This scientific and technological capacity is mainly placed within the scope of universities and the public sector (G and I ).1 All of these factors have made Chile a very attractive place for bioprospecting projects. In spite of the above-mentioned, in Chile there has not been a parallel institutional and legislative development, with specific policies and laws established to regulate access to national genetic resources. Unfortunately, the complexity of the subject and the lack of political will have determined the complete absence of any kind of regulation. Chile does not have an official policy or a national strategy to confront any of the multiple subject areas of the utilization of genetic resources. Even though the  is a national law, the government and the political authorities have not yet given much significance either to this matter or to other important aspects of biological diversity. The situation is such that after more than nine years Chile has just completed its National Biodiversity Strategy and has initiated (mid-) its National Biodiverity Action C : C Plan.for the conservation and sustainable use of its biological diversity, nor has it fulfilled many of the obligations acquired when it ratified the . Since the date in which the  finally entered into force in Chile2, the National Commission of the Environment () and the Ministry of Agriculture (through its different departments and offices) have been the two governmental institutions mainly responsible for the implementation of the different provisions of the . Even though  has the general institutional task of coordinating the action of all the public entities with environmental responsibilities, in Chile the administrative authority that specifically manages the several components of national biological diversity is dispersed among a variety of institutions; in addition, these components are more often handled under the ideological conception of “natural resources” rather than of biodiversity. Furthermore, among the regulations related to the subject there are many cases of overlapping principles and provisions, which cause considerable confusion and, in the particular circumstance of genetic resources, an almost total lack of institutional definitions. In fact, though it could be said that the corresponding articles of the  constitute the only legislation for access and benefit sharing that there is in Chile, it is a useless regulation, because it has not yet been properly implemented in the internal legal framework. This means that even though the basic rules exist, they are neither applicable nor enforceable. This situation has occurred because there are no authorities with specific responsibilities on this particular matter nor there is a mechanism to allow the rules and principles of the  to operate at the national level. So far, the only effective rules that regulate the exchange and the utilization of genetic resources in Chile are private arrangements, made under civil law, between stakeholders, upon whom the principles and provisions of the  can not be legally imposed, because of the lack of competent authorities and of an adequate national regulation. Indeed, the implementation of an international legal instrument within a national legal regime cannot be made by the direct incorporation of its rules to the national legislation through a simple administrative or legislative act. Implementation should be a much more complex process. In fact, the success of such a process is essentially determined by the feasibility of the international rules to actually operate in an efficient and effective way at the internal level. On the other hand, the way in which the national implementation of international treaties takes place is widely determined by the degree of evolution of the internal legal and institutional framework. To carry out an effective and efficient process of implementation the internal legislative regime would, at a minimum, have to: • Define and determine certain principles, objectives, priorities, and goals in relation to the matter. • Impose certain obligations upon the authorities and the citizens of the country in relation to the provisions of the international treaty at issue. • Prevent possible conflicts between the regulations in force and the provisions of the international treaty and, if necessary, create a mechanism to solve such legal conflicts. • Establish an institutional structure to fulfill the previously determined objectives and goals, unless an existing structure is already sufficient. Finally, for a national legislative regime to be really suitable for implementation, besides the fulfillment of the minimum conditions previously indicated, a serious and detailed assessment of the national legislation already in force should be made, and a national plan, capable of covering general and specific aspects of the matter, should be elaborated (with the purpose of fulfilling the particular principles and objectives of the international treaty at issue).3 So far, in relation to the , and specifically in the area of genetic resources, none of the above has been done in a systematic and considered way by competent Chilean authorities. What then has been the local evolution on the subject of genetic resources? As mentioned before, shortly after Chile’s ratification of the , there was a significant effort to start a process for developing a national legislation on access and benefit sharing. This initiative was mainly conducted by the Department of Natural Resources of , which tried to coordinate the different national authorities that could eventually have some relation to the subject. After some internal debate, a working group was created with the participation of officials of , the different departments and offices of the Ministry of Agriculture (Agricultural Studies and Policies Office (), the Agriculture and Livestock Service (), the National Institute for Agriculture Research (), and the National Forestry Corporation ()), and the Ministries of National Goods and Foreign Affairs. Besides taking the first steps to initiate the national debate on access and benefit sharing, one of the main efforts of the governmental working group on genetic resources was to try to identify the bioprospecting projects that were currently going on in Chile and interviewing those in charge of such projects. In fact, the presence of international institutions that, directly or through national universities, were carrying out such initiatives in Chile was one of the factors that provoked the interest of environmental authorities, making them aware of the need to implement the provisions of the  on access and benefit sharing of genetic resources in Chile. In , a couple of public seminars were conducted by the environmental authorities in order to generate national awareness on the subject. In the same year, an administrative agreement between the Ministry of Agriculture and  was signed, with the purpose of creating a National Program for Plant Genetic Resources. In , after an internal institutional workshop organized by  and the Ministry of Agriculture, a National Commission on  A B  S  B Genetic Resources was informally created. The formation of this commission never had a supporting legal provision and its constitution was based only on an agreement among public officials. The work of this commission never gave any significant results. In less than a year, after two or three meetings, it vanished. Throughout  and , a couple of consultants were hired by  in order to analyze the national legislative situation and propose ways of developing a national regulation for genetic resources. After some internal debate, it was concluded that the only way to initiate legislation capable of enabling the governmental authorities to manage the exchange and utilization of genetic resources in Chile was by confronting the question of ownership of genetic resources, through some legislative changes in the property regime. This conclusion turned out to be the main obstacle for continuing with the regulating efforts of the time. This occurred because in the Chilean Constitution the property regime gives very strong protection to private property, and in order to make any kind of change to such a regime, it would be necessary to have a special quorum in the National Congress ( ). Some efforts were made by the relevant administrative authorities to explain to congressmen the importance of this subject and of its regulation, in order to take the first steps in the process of developing a national access and benefit-sharing framework. Unfortunately, the issue was not really understood and the political authorities of the country never considered it important. By the end of , most of the officials who were originally actively involved in this process had left their positions in the public sector, and the current political and administrative authorities were not worried about bioprospecting projects going on in Chile anymore. So, the process started to lose the momentum it had previously had. Since ,  had not been directly involved in any significant activity related to this subject until the end of , when the issue was considered again by the Department of Natural Resources.4 At the Ministry of Agriculture, efforts on the subject continue, on a much smaller scale; they are mainly carried out by , but the political importance originally assigned to this matter by the Ministry has been lost. Nevertheless, the Ministry is the only authority that has been permanently working on this issue by studying a way to solve the legislative obstacles related to ownership of genetic resources and by developing a ministerial policy regarding the protection and economical valuation of national genetic resources (A ). In late , the Ministry completed a first draft of a legislative proposal regarding access to and sharing of benefits derived from agricultural genetic resources, but it was discarded after being criticized by some sectors. However, since efforts to develop a better proposal continues, it is important to discuss some of its main elements:there is no public information about when  it would be submitted to the National Congress. The main characteristics of this proposal are: • Its scope of application was limited to agricultural genetic resources. • It was a stand-alone and brief piece of legislation which only established the basic framework of the access system and the obligation to inform the Ministry of any bioprospecting project. A future proposal will therefore need further elaboration and the enactment of administrative regulations to determine, for example: a) the authority that would sign the agreements in the name of the Ministry; b) the kind and contents of the access agreements; c) the information required; d) the way in which benefits will be shared, and; e) the way in which traditional knowledge will be protected. It can be argued that the original initiative to start a process of developing a national regulation for access and benefit sharing in Chile was aborted at a very early stage. It was never based on a real national policy for biodiversity, and its beginning was essentially determined by circumstantial facts, such as governmental concern about bioprospecting projects going on in Chile at the time and the need to fulfill the obligations acquired by Chile when ratifying the . The current initiative promoted by the Ministry of Agriculture lacks the support of a national policy for biodiversity which would allow the discussion and adoption of a regulation on this matter based on a serious commitment of the government and a broad acceptance by the different stakeholders. Finally, concerning the  International Treaty on Plant Genetic Resources, in March  the Ministry of Agriculture started a process of consultation and analysis within the public sector, in order to determine the consequences and benefits that signature and ratification may have for Chile. After a few months of discussions Chile signed the  Treaty on  November . The Ownership of Genetic Resources The  makes no reference to ownership of land or genetic resources, dealing only with access to genetic resources and sovereign rights over natural resources. Questions of ownership and tenure inevitably have an important bearing on the practicalities of bioprospecting and are an important element of national legislation and policy that governments can use to “determine access” to resources, yet they are often overlooked by policy-makers. Users of genetic resources must be sure that the supplier has the authority to collect and provide such resources, or the  requirements would not be fulfilled. Such authority may rest not only with the government but also with those who have private rights or tenure over the land or resources. Because of this, at a certain point, governmental authorities may have to clarify the relationship between the ownership, tenure, and access regimes. C : C  The international recognition of sovereign rights over genetic resources within national territory constitutes the foundation and the theoretical framework over which each State has the responsibility to specify its own legal regime, in order to establish concrete and specific rights, over concrete and specific resources. This international recognition only means that the State, by virtue of its sovereignty, has the legitimate right to “define and determine” the type and the modalities of property that are recognized, according to the principles and rules of its internal legal framework and in harmony with the international commitments that it has acquired. As with the legal framework for access, the different possibilities through which the sovereign power of a State can determine the property regime for genetic resources are multiple and diverse. In order to enact and implement a particular legislation, one of the first tasks is to define the object that will be regulated and the ownership of the rights attributable to this object, particularly property rights. The determination of a specific property regime requires a clear identification of the goods to which it refers and of the rules and principles according to which it will be structured. In the case of genetic resources, this subject is new, extremely complex, and, in most countries, has still not been seriously confronted. Today, private property prevails in the majority of the legal systems of the world. However, there are certain resources that are considered of such value for national interests that its ownership is left in the hands of the State. Other resources, however, are placed under the regime of private property and will belong to individuals or to the State, according to the rules and principles of the applicable legislation. Thus, nations usually retain certain goods under their control as public property (for example, in some countries mining resources are State-owned) and, in addition, they may maintain ownership of some goods as private property. Public property can be declared with respect to individualized and quantified goods, or with respect to an undetermined amount of resources belonging to a certain category. Such is the case, for example, in the public property established over waters or oil reserves. Considering all that has been already said, it must be held in mind that both the definition and the implementation of a property regime (public or private) or other types of rights, in relation to genetic resources, are limited by the intrinsic nature of such resources. For any property regime on such resources to be effective, the subject to which it refers and the type of rights that are going to be granted must be defined in a suitable way. In the first place, it is necessary to establish a distinction between rights on the physical entities (the physical property or plant-animal) and the eventual rights on the genetic information contained in such entities (intangible property). The real value of genetic resources lies in the second element, and the legal questions that arise in relation to it are particularly complex. In order to know how Chile interprets the legal defini- tion of genetic resources, it is necessary to identify the legal provisions that, directly or indirectly, regulate the subject. The only definition of genetic resources that exists in the Chilean legal regime is in Article  of the , which, in the absence of any other legal provision, determines the conceptual framework of the regulated object. With regard to attributing ownership or tenure to genetic resources, it is necessary, in the first place, to identify and analyze the general provisions of the property regime in the national legal framework and then to check if they are applicable to the objects that are legally conceptualized as genetic resources. If there is not such an express provision by extension the applicable provisions will be those that regulate the property of the biological resources which contain the genetic resources ( ).5 The Political Constitution of the Republic lacks all explicit reference to biological diversity or some of its elements; neither does it refer to it through other concepts, such as flora and fauna or plants and animals. It only alludes indirectly to these realities, when imposing on the State the constitutional duty of “maintaining for the preservation of nature”, when determining that by law it will be possible to establish specific restrictions on the exercise of certain rights or liberties in order to “protect the environment” (Article , Number ); and when indicating that a fundamental concept of the social function of property is “the conservation of the environmental patrimony” (Article , Number ). In addition, the Constitution establishes “the freedom to acquire the ownership of all types of goods”, with the single exception of “those that nature has made common to all men or should belong to the Nation and that the legislation has thus declared” (Article , Number ). This provision, besides being a constitutional guarantee, establishes the freedom to acquire all types of goods as the general rule of the Chilean legal property regime. Under this provision, the possibility of acquiring property of any type of biological resource is totally granted (in conformity with the provisions of the Civil Law on goods and acquisition of ownership), unless a Law of Higher Quorum, when it is demanded by the national interest, establishes special requirements or limitations to the acquisition of the ownership of such goods. The Constitution sets forth general rules for structuring the national property regime, but it is the law’s responsibility to specify the particular regime of property applicable to specific goods and to establish the ways to acquire ownership. Therefore, it is necessary to review the pertinent provisions of the Civil Law. The few references in the Civil Code to biological resources are made according to obsolete conceptual categories that have nothing to do with biological diversity. In relation to those biological resources that can be included in the concept of fauna, the Civil Code establishes that domestic animals are linked to the land they serve and that wild fauna such as fish, birds, and others are considered freely acquirable goods, in the condition of res nullius.6 In  A B  S  B relation to those biological resources that can be included in the concept of flora, the Civil Code considers that they follow the ownership of the land in which they are located. Given the fact that under the Chilean property regime there are no lands without an owner, the different biological resources associated with flora will be the property of the individual owners of the respective land or, in their absence, of the State of Chile. In relation to microorganisms (fundamental raw material of the biotechnological industry), national legislation has not established any type of provision for regulating their ownership regime. This is the general legal framework that regulates the property of biological resources in Chile. There are other laws and regulations that deal with questions relative to the “handling” of biological resources, but they do not alter or modify the general regime of property established by the provisions described before.7 Evidently, in Chile’s legal framework on property there is no particular and differentiated regime to regulate the question of ownership of genetic resources. Genetic resources constitute a new legal object, still not recognized by the legislature, and their ownership is not specifically regulated by any particular regime. Therefore, we can assume that, considering the nature of genetic material and the legal principle indicating that the accessory follows the principal or main thing, in Chile genetic resources are placed under the property regime applicable to biological resources, such as animals and plants. In addition, an analysis of the provisions charged with attributing competencies and establishing rules for access will allow the identification of interests and objectives of an eventual national policy regarding the matter in question. As noted before, under current legislation Chile does not have a regulation directly establishing the competent authority regarding access to genetic resources. Indeed, genetic resources are not treated as such by any law, apart from the mandates established by the . Nevertheless, taking into account the legal framework applicable to biological resources, there are several public institutions that could potentially serve as the competent authority regarding certain aspects related to access. These are: the Ministry of Agriculture (through , , , and ); the Ministry of Economy (through the Fishing Undersecretariat, the National Fishing Board (); and the Forestry Institute); the Ministry of National Goods; the National Commission on Scientific and Technological Research; ; and the National Corporation on Indigenous Development (). Chile does not have any authorities with a specific and exclusive competency in genetic resources; nor does it have any particular regulation concerning access to such resources. In practice, as is the case of property, the only mechanism that might come near to fulfilling such a role are the legal provisions charged with regulating access to biological resources. The Regime of Access to Genetic and Biological Resources Access to biological resources found in fauna Chile’s legal structures generally define the components of fauna as res nullius, that is, as a good that does not belong to anyone. This legal situation allows the state to establish, via the corresponding mechanisms, certain restrictions to the access to these biological resources. In order to review the mechanisms we will distinguish between nonwild fauna, wild fauna, and hydrobiological species. Access to faunal biological resources not included in the wild fauna category only requires the authorization of the owner of the land and specimen. In contrast access to biological resources found in wild fauna species, where such access necessarily requires the species’ capture or hunt, will always need, in accordance with the Hunting Law, a hunting permit or license.8. This permit or license is also required for owners of estates where hunted animals are found. Since the law states that ownership of biological resources is not granted through the use of wild fauna species nor of its products, by-products, or parts if this is carried out by transgressing the regulations of the law or its jurisdiction, the permit or license may be particularly relevant. Hunting permission is granted by .9 A hunting permit allows the bearer to hunt big or small game as indicated. Granting permission is subject to passing an exam and payment of a fee. However, there are certain cases in which hunting or capture is prohibited or restricted. This potentially controversial situation also implies the prohibition or restriction The ratification of the  brings with it obligations that can be difficult to implement and that require profound changes in the internal legal framework. Article  of the  defines the obligations and rights of the Member Parties with respect to access to genetic resources and their subsequent use. These obligations and rights are based on the following principles and fundamental rules: • National sovereignty over genetic resources and, as a consequence, the full authority of national jurisdiction to regulate access to such resources; • Access to resources subject to the prior informed consent of the supplying nations; and • Access to resources subject to mutually agreed terms and conditions that will define, in a concrete and specific way, the manner in which the sharing of the benefits will be carried out. Two issues are basic for the development and implementation of a system of access in Chile: • Determining the competent authority or authorities in charge of access to domestic genetic resources (competent national authority), and, secondly, • Identifying the provisions regulating the way in which the access procedure should be carried out.  C : C of access to the corresponding genetic resources. The following is a brief description of such cases: • Hunting or capturing is prohibited in areas which constitute protected zones or other special zones.10 Regardless of the latter,  may give authorization for scientific aims, such as controlling the activities of animals that cause serious damage to the ecosystem, establishing reproduction or breeding centers, or allowing the sustainable use of a resource. • Hunting or capturing species in danger of extinction or vulnerable, rare and scarcely known species is prohibited, as is hunting or capturing species regarded as beneficial to forestry, fishing, and agricultural sciences, or to the maintenance of the equilibrium of natural ecosystems, or species with reduced population densities. Regardless of the latter,  may authorize such hunting or capture when the authorized party proves that hunting or capturing of specimens is necessary for research, for the creation of reproduction or breeding centers, for the sustainable use of a resource, or for controlling the activities of animals that cause serious damage to the ecosystem. In any case, the corresponding authorization should indicate the prevalence of the species, the maximum number and type of specimens whose hunting or capture is being authorized, and any other conditions under which the extraction will take place. • For species not included in the above cases, the law establishes hunting and capturing seasons and areas, as well as the number of specimens that may be hunted or captured per day, season, or age group. The only exceptions to these restrictions are certain species of wild fauna which are considered harmful and which may thus be hunted or captured at any time of year, throughout Chilean territory and regardless of quantity or specimens. However, a hunting permission or license is still required for these species. • On the other hand, the international trade and transportation of wild fauna species must be carried out according to the provisions established by the Convention on International Trade of Endangered Species (). This international treaty aims to regulate the trade and transportation of wild animals and plants considered to be in danger or threat of extinction. This regulation not only encompasses live flora and fauna species but also includes all their derivatives and by-products (stuffed animals, furs, bones, tissue samples, pharmaceutical products, etc.). Although this Convention refers only to the protection of species and not to genetic diversities, its provisions constitute, in practice, an eventual requirement to be met in the case of international trading of a genetic resource contained in any one of the species included in the treaty. Regarding the regulation of access to biological resources found in hydrobiological species, we should essentially consider the rules established by the General Fishing and Aquaculture Law which regulate the procedure of access to these resources in reference to fishing for extraction and research. Extractive fishing activity may be industrial or traditional. Regarding the former, the law establishes a general mechanism and a special mechanism of access to resources that apply to Chilean Territorial Sea and Exclusive Economic Zone, with the exception of areas reserved exclusively for traditional fishing. The general mechanism of access to industrial extractive fishing means that persons interested in carrying out industrial fishing must request a fishing permit for each vessel. This permit is granted for an unlimited period of time according to the species and zones outlined. On the other hand, there are special access mechanisms applicable in the case of resources which are currently being fully exploited and in which fishing systems are in recovery or just starting. For every fishing unit declared to be in any one of those states, a management plan must be developed which must outline, among other elements, the means of conservation and access mechanisms which apply in the particular case. For traditional fishing the access mechanism is that of freedom to fish. However, in order to carry out their activity, traditional fishermen and their vessels must previously register with the registry coordinated by . In any case, with the aim of protecting hydrobiological resources, granting permits may be temporarily suspended (by traditional fishermen category or by fishing company) when one or more species becomes fully exploited. Regarding research fishing, the law determines whether the species and areas are subject to a general or special access mechanism. In either case, the Fishing Undersecretariat is responsible for authorizing the capture of corresponding hydrobiological species according to the approved research project. In the case of special mechanisms, global quotas, if they exist, must be obeyed. Certain mandates also exist that allow restrictions on access to hydrobiological species with the aim of protecting and preserving the species. These mandates refer to the establishment of prohibition periods (biological, extractive, or extraordinary); to the temporary or permanent prohibition of capture of hydrobiological resources protected by international treaties in force in Chile; to the establishment of marine parks and reserves; and to the fixing of annual quotas of capture by species in a defined area. Lastly, regarding the regulation of access to biological resources found in fauna in general, the restrictions on the capture of determined species set out by international treaties signed by Chile must also be considered. Among these we highlight the following: the International Agreement for the Regulation of Whaling (), the Convention for the Conservation of Antarctic Seals (), the Convention on Wetlands which is of international importance specially regarding the habitat of waterfowl, the Convention on the  A B  S  B Conservation of Migratory Species of Wild Animals (), and the Convention for the Conservation and Management of the Vicuña (), all in force in Chile. By virtue of the above mentioned regulations we may conclude that access to biological resources found in fauna is quite exhaustively regulated in Chile. The only exceptions are land invertebrates which have not been included in the mentioned provisions. Access to biological resources found in flora Flora, in general, is considered by Chile’s legal structure as a property that is defined by the fact that it is rooted to the ground; it thus belongs to the owner of the land in which it is found.11 This legal situation prevents the state from establishing, in general terms, restrictions upon these biological resources. Regardless of this, Chile’s legislation has a variety of laws and policies that regulate, particularly for certain cases, access to the biological resources found in Chilean flora. In the first place, it is relevant to refer to the mandates directly related to the collection of plant material. The Forestry Law constitutes the first legal framework that regulates this aspect. The following are prohibited by Article : • Cutting down of native trees and shrubs located less than  meters from fresh waters that spring from the hills and less than  meters from water banks from the point at which the fresh water arises until it reaches level ground; • Cutting down or destruction of woods located within a  meter radius of water supplies that originate in plain terrains that are not watered; and • Cutting down or exploitation of native trees and shrubs located on land that slopes over %. Regardless of the latter, cutting down in such sectors may be possible when duly justified and with previous approval of an operating plan in conformity with Decree Law No. , . This mandate allows restriction of access to the biological resources contained in Chilean tree and shrub species, especially in specific in cases which Chile’s legislature considers the species in need of protection. Nevertheless, this is not an absolute prohibition since 12 can expressly authorize this collection on “justified grounds”. On the other hand, the Decree Law No.  on Forestry Promotion also indirectly regulates the cutting of forests and plant material, by establishing incentives for the substitution of forest plantations. Another law, Decree Law No. , (The Agricultural Protection Law), establishes certain mandates in relation to exportation of plant products, requiring a sanitary certificate issued by 13, thus restricting the international transference of plant material. Finally, regarding the commerce and international transportation of wild flora species, the mandates that can be applied are those agreed upon by , which has been discussed above with regard to wild fauna.  With such few mandates in mind, it can be concluded that Chile’s legal framework does not expressly regulate access to plant material. Indeed, there is a huge imbalance in the regulation of access between floral and faunal biological resources (I ). Regarding this, the current legislation on the matter of protected areas is of great relevance, as are the requirements that define the access to these areas, because both are indirectly applicable to the plant material found in them. This legislation is composed of the following legal texts: the Supreme Decree No. , , approved by the Convention for the Protection of the Flora, the Fauna and the Natural Scenic Beauties of the Countries of America (Washington  Convention); Law No. ., the National Monuments Law; Decree Law No. , on Purchase, Administration, and Disposition of State Goods; Supreme Decree No.  the Forestry Law; Law No. ., that establishes Protected Areas for Tourism; Law No. ., that creates a National System of Wild Areas Protected by the State14; and the Environmental Framework Law No. .. According to these laws, the following main categories of protected wild areas exist: National Park: A generally extensive zone, where diverse environments that are unique or that are representative of the country’s natural ecological diversity are found. These are not significantly altered by human action, are capable of self-perpetuation, and their flora, fauna, and geological formations are of special interest for scientific, educational, or recreational reasons. The objectives of this category are the preservation of our natural environments with the cultural and scenic characteristics that are associated with them; the continuity of evolutionary processes, and, whenever compatible to the aforementioned, research, educational, and recreational activities. The national parks constitute fiscal property, although some parks are partially owned by private organizations. This category of protected areas is constituted by Supreme Mandate of the Ministries of Agriculture and National Goods.  authorizes the operating plans of the activities that are carried out inside each protected zone. Forest (or National) Reserve: An area whose natural resources need particularly careful conservation and use because of its susceptibility to degradation or its relevance to the community’s well being. The aim of this category is the conservation of soil and water of threatened species of wild fauna and flora, the maintenance or improvement of water production, and the development and application of efficient technologies of advantage to flora and fauna. A regulated intervention is allowed in these areas and it is therefore possible to give concessions and approve operating plans in them. Nevertheless, in practice handling plans for forest exploitation are only granted to fiscal entities. They are constituted by Supreme Mandate of the Ministry of Agriculture and their administration is also a responsibility of . National Monument: A generally reduced area, characterized by the presence of native species of flora and fauna C : C or by the existence of geological sites that are relevant from a scenic, cultural, educational, or research point of view. The aim of this category is the preservation of natural environmental samples and associated scenic and cultural characteristics and, whenever compatible, research, educational, or recreational activities. National Monuments have the same characteristics as national parks but are smaller areas or defined objects (e.g., the Araucaria and Alerce trees). They are also constituted by Supreme Mandate of the Ministry of Agriculture and  is responsible for their administration. Natural Sanctuary: Land or sea areas whose natural resources are so relevant that they offer special possibilities for scientific research. These areas are created by Supreme Mandate of the Ministry of Education (Council of National Monuments) and in practice they are nearly all privately owned lands. These areas allow forest exploitation under approval of an operating plan. In conformity with the National Monuments Law, all activities carried out in a Sanctuary need approval from the Council of National Monuments. Protected Areas for Tourism: Areas comprised of private land of great scenic and tourist value in which  regulates the cutting of trees and undertakes measures to protect natural resources. These areas are created by Supreme Mandate of the Ministry of Agriculture. Furthermore, according to Law No. ., all works, programs, or activities to be carried out must be submitted to the Environmental Impact Assessment System, coordinated by . This applies to national parks, national reserves, natural monuments, virgin area reserves, natural sanctuaries, marine parks, marine reserves, or any other areas under official protection, when the respective legislation so permits. Thus to be able to carry out any activity in a protected area, including access to the biological resources found in it, an authorization from the appropriate authority and the corresponding environmental qualification is required. Finally, it is also important to mention the mandates established by Indigenous Law No. ., in which article No.  refers to indigenous participation. It declares that state administrative services and organizations that deal with territorial matters must take into account the opinion of the indigenous organizations acknowledged by this law when considering topics related to indigenous issues. Likewise, Article  states that the administration of protected wild areas that are in the indigenous development zones must include the participation of its communities.  or  and  will decide the manner and depth of participation on the rights of use of the area that correspond to the indigenous communities. In conclusion, the current procedures in Chile regarding access to biological resources do not meet the main objective of the  with respect to the regulation of access to genetic resources: that is, the fair and equitable sharing of the benefits resulting from its use. Indeed, the procedures that we have taken into consideration regard- ing biological resources have specific objectives that are different from those established by the ’s system of access to genetic resources. The National Program for the Protection of Plant Genetic Resources In Chilean institutional practice,  is the only public sector institution that has actively dealt with the issue of conservation and utilization of genetic resources (specifically plant genetic resources). This has been done through a Program on Plant Genetic Resources, with the general objective of looking after the preservation and distribution of both Chilean and foreign germplasm, and of trying to increase its availability for future generations (C and L ). With the aim of obtaining official support for this Program of Development and Protection of the Country’s Plant Genetic Resources,  and the Ministry of Agriculture signed an agreement on  August . According to the agreement, the general objective of this program is to safeguard the preservation and interchange of germplasm of wild plant species and those improved and obtained by the State. Its specific objectives are the following: • Avoid loss and promote better use of Chile’s plant genetic material. • Support and coordinate work on genetic resources carried out in Chile and other countries promoting national and international collaboration. • Generate, with the use of Chile’s plant genetic resources, new crops or variants, to be incorporated into the national production. • Establish and operate germplasm banks. • Propose to the Ministry policies for the handling and interchange of germplasm. The actions carried out by the program are the following: • Exploration and collection15: The agreement establishes that  must verify that all explorations or collections of plant genetic resources that are state property must be carried out according to the following requirements: − A request for exploration or collection must be made with tentative plans for the field mission, including the types of materials to be collected, their species and quantities, and the subsequent evaluation, storage, and use. Also, required is a description of the distribution of the germplasm that will be carried out and the information that those in charge of collection must present once the mission has finished. − The exploration or collection must be carried out with the participation of national equivalents designated by  and paid for by the collectors.  A B  S  B • • • •  − The Ministry of Agriculture can forbid the collection of certain species and establish areas where collection cannot be carried out. Likewise, it can establish the types, origin, and quantities that must be deposited in Chile. − Priority is given to requests of exploration or collection by the classification of species, as follows: native-grown species; native species of a potential interest; naturalized foreign species; species long introduced but that have not been collected or that have a low representation in the country’s collections; ancestral species of cultivated species; and wild species related to cultivated species. Documentation, characterization, and evaluation of the resource16: Adequate information on the collected resources must be obtained (botanical descriptors and physiological, genetic, agronomic, industrial, and biochemical characteristics) in coordination with specialized personnel evaluating and characterizing the germplasm. Conservation17:  must use germplasm banks as its genetic resource conservation system with a basic collection and, when appropriate, an active collection, of each stored species. Information and distribution of genetic resources18:  will publish periodically updated catalogues of the genetic material stored in their banks. This material will be grouped in three distribution categories: free, restricted, and prohibited distribution. This classification is based on the desire to maintain a policy of reciprocity between research organizations and as well as the need to keep material that clearly represents a competitive advantage in the context of international commerce. Until now,  has not classified any genetic resource in the prohibited distribution category. National guardian of plant genetic resources19:  acts as National Guardian20 of Chile’s plant genetic resources, with the responsibility to define and determine priorities regarding the existing species in Chile that are considered as genetic resources; verify compliance with the general regulations established by the Ministry of Agriculture regarding the conditions under which the explorations and collections of Chile’s genetic resources will be carried out; conserve in the germplasm Bank System samples of genetic resources entrusted by the state or left in custody by private entities; define the conditions that must be complied with when depositing in the germplasm Bank System; carry out follow-up and monitoring of the deposited samples; multiply and regenerate the deposited samples; document and report the existence of genetic resources conserved in the system; distribute and use the genetic resources that are entrusted by the state under the established regulations; and certify compliance with the regulations established by the Program for export of genetic material. • Introduction of germplasm into Chile21: All internment of germplasm for  must be backed by a sanitary plant certificate issued by the organization officially in charge of plant sanitation in the country of origin, and the germplasm must be submitted to quarantine post-entry measures required by . In compliance with this Program, in past years  has subscribed to different bioprospecting agreements under a contractual approach, trying to follow the rules of the . Nevertheless, being only a research entity,  does not have any institutional authority over national plant genetic resources nor has it any regulatory authority at all. So it cannot be said that these agreements are part of public policy or regulation on the matter. Intellectual Property Rights and Genetic Resources The intellectual property protection system currently in force in Chile has two different formulas that apply to inventions related to biological resources. These are patents, regulated by Law No. ., , and breeders’ rights, regulated by Law No. ., . Both formulas have different scopes and structures. The breeders’ rights system only applies to plant varieties, which are expressly excluded from the patent system. Regarding the awarding of a patent and the consequent protection given to biotechnological innovations (products or procedures), the current legislation expressly excludes only the patenting of plant varieties and animal species.22 Therefore, according to the tenor of Article  of the Regulation of Law No. . “inventions related to biotechnological procedures and products that either consist of life material or contain it” can be patented. This allows the patenting of inventions carried out on genetic material, but the patent must refer to an invention, not a discovery, and the requirements stipulated by Law No. . and its regulation must be complied with. Given that inventions based on plant varieties and associated biological material (mainly seeds) are not covered by patent protection, they may be subject to protection via the breeders’ rights mechanisms, as stipulated in the International Union for the Protection of New Varieties of Plants () treaty and Law No. .. Thus, plant varieties can be subject only to breeders’ rights, but inventions based on biological material of plant origin (that are not included in the concept of variety) may be protected either by the breeders’ rights system (indirectly, since the protection includes the variety of which it forms a part) or by the patent system (directly, on any innovation). Regarding animals, there is no special legislation in Chile that contemplates a specific protection system, as with plant varieties. Nevertheless, material of animal origin C : C can be protected by means of the patent system, as long as the stipulations and requisites of Law No. . and its regulation are complied with. In the case of microorganisms, cellular composites, and other biological classifications, apart from those indicated by Article  of the regulation of Law No. ., there is no provision that, directly or indirectly, refers to their inclusion or exclusion from the patent system. Given the fact that patentability is the general rule of the system and considering the reference to Article , it can be concluded that the aforementioned materials may be the object of patent protection, if and when the respective inventions comply with the requisites stipulated by Law No. . and its regulation. Since the legislation that regulates patents has a general rule of broad patentability, alongside the mandates of Article , the possibility to patent all kinds of inventions based on diverse biological resources exists. Nevertheless, it is important to note that this is only a possibility and does not imply a systematic patenting of forms of life. Although the possibility exists, the system enacted in the respective legislation was not elaborated with such cases in mind, and, for now, does not have the necessary structure and institutionalization to handle the complexity surrounding the attribution of intellectual property rights over different life forms. It is the responsibility of the qualified institution (Department of Industrial Property of the Ministry of Economy) to determine the extent of the protection granted to the patent system of Law No. .. Beyond the possibility of patenting inventions carried out on live material, it is fundamental to define a national policy on the subject of intellectual property and its scope. A harmonious regulation can be established, with clear and efficient rules, founded on objectives relevant to national interests. Given the tremendous complexity of its implications, the possibility of attributing or not attributing intellectual property rights to biotechnological inventions must comply with such a national policy and not only manifest the interests of some sectors. In its current state, the legislation is unsystematic and vague in many of its mandates and concepts. This leaves the door open for a variety of interpretations and applications. With this reality in mind, we will refer briefly to the current process of modification of the Chilean intellectual property legislation. It began in  with the presentation of a Bill by the Executive Power in the National Congress23. that seeks to adapt the Chilean legislation to the international obligations it undertook by subscription to the Marrakech Agreement. (Indeed, by virtue of the ratification of the Marrakech Agreement, Chile acquired the obligation to adapt its internal legislation in matters of intellectual property. The deadline originally established was  March . Today, Chile, like many other developing countries, has not complied with this stipulation). Nevertheless, as we have already mentioned, during  a Bill introducing modifications to Law No. ., Related to the Regulations Applicable to Industrial Privileges and Protection of the Rights of Industrial Property, was submitted for consideration in the Chilean Chamber of Deputies. The aim of the Bill is “the execution of obligations that, in matters of industrial property, were adopted by the Chilean State within the framework of the Marrakech Agreement, modifying Law No. . in conformity with the stipulations established in that international legislative body”. Likewise, this Bill introduces some modifications to current laws that are destined to complete and comply with the Paris Agreement (in force in Chile since ). Regarding the modifications proposed for the patents system, the main changes are related to the period of protection of the rights conferred by the patent (it increases from  to  years) and the procedural aspects for the granting of this right. Specifically, in relation to the patentability of different forms of life, the Bill reproduces, nearly identically, Article ..b of the Agreement on Trade-Related Aspects of Intellectual Property Rights. Thus Article  of Law No. . would indicate the following: The following will not be considered as an invention and will remain excluded from the patent protection of this legislation: b) Plants and animals, excluding microorganisms, and essential biological procedures for the production of plants or animals, that are not biological or microbiological procedures. The plant varieties will benefit from protection whenever they can stay within the boundaries of the mandates of Law No. . on breeders’ rights of new plant varieties. To illustrate some aspects of this incipient discussion in Chile on this matter, we will refer to the most relevant suggestions that have been formulated during the discussion of this proposal in Congress (C  D ). For example, a request has been made to add a new letter f) to Article  that establishes that the following would also be excluded from patent protection: All or part of living beings as they are found in nature, the natural biological processes, the biological material found in nature or that which may be isolated, including the genome or germplasm of any natural living being. This suggestion was proposed with the aim of preventing the possibility of patenting any kind of genome (plants as well) and not only human genomes. Regarding biotechnology, the relevant suggestions are those formulated in relation to the current Article  of Law No. . that states: An invention can be patented when it is new, has an inventive level, and is susceptible to industrial application. The Bill in process does not incorporate modifications to this article; nevertheless, there have been proposals in the parliamentary discussion offering suggestions that would modify it. For example, one proposal would substitute the following for the text of this article: Patents can be obtained for all inventions, be they prod-  A B  S  B ucts or procedures, in all fields of technology, with the condition that they be new, have an inventive level, and are susceptible to industrial application. Regardless of Article  of this Law, patents can be obtained and the rights of the patents can be used without discriminatory aspects such as the place of invention, the field of technology, or the fact that the products are imported or produced in the country. There has also been a proposal to add a second paragraph to Article , as follows: The principle of non-discrimination in technical fields will be recognized by safeguarding and respecting our national biological and genetic patrimony, as well as the traditional knowledge of indigenous or local communities. As a consequence, the concession of patents for inventions developed on the basis of material obtained from that patrimony or knowledge would be subject to the acquisition of the material in conformance with the relevant international and national Regulations. It is also important to mention the paragraph formulated by Article  of Law No. . which currently states that: Patents are not awarded to inventions that infringe upon the law; public order; state security; ethics and good customs; nor to any inventions presented by whomsoever is not the legitimate owner. As with Article , the original bill did not modify this article. However, the Chamber of Deputies formulated the following paragraph, which aims to replace the text of Article  with the following: Patents cannot be awarded to inventions whose commercial exploitation needs to be prevented in order to protect public order, state security; ethics and good customs; the health or life of persons or animals, or to preserve plant material or the environment, whenever such an exclusion is not carried out due to the existence of a legal or administrative clause that prohibits or regulates said exploitation. The Chamber of Deputies’ Permanent Economic Commission, which is in charge of studying the Bill in question, has approved all the above-mentioned paragraphs. We must say, that in Chile, almost all biotechnological development is carried out by universities and a few government agencies (mainly  and ), with the fundamental aim of preserving resources and developing scientific research. Chile does not have a significant biotechnological industry, nor does it have a particularly developed economic activity in this area. Therefore, most of the pressure for a better adaptation of national intellectual property legislation to the patenting of biotechnological developments originates from abroad. To date, this pressure has not been significant. Bioprospecting Projects in Chile There is currently neither a regulatory framework nor a clear policy regarding this issue. Thus, regarding the activity of access to genetic resources (bioprospecting projects) the approach taken is predominantly contractual and is defined by the particular interests of the contracting parties and controlled by the regulations of private law (national or international). It does not include the concrete participation of the country’s environmental authorities. Practically all cases of bioprospecting have been carried out via Chilean universities and with the supposed aim of developing research ( ). Since Chile does not possess a developed biotechnological industry and no Chilean stakeholder have shown an interest in developing the sector, most of the bioprospecting projects have their origins abroad, be it in the private or public sectors. Given the fact that no entry control system exists, nor is there an obligation to register, no precise information is available regarding the exact number of bioprospecting expeditions that have been carried out or are currently being carried out in Chile. Nevertheless, these expeditions can be categorized into two clear groups: specific expeditions, carried out on a small scale and in relation to certain very special species (these probably constitute the majority but are less often registered), and large scale bioprospecting programs, which consist of the systematic analysis of samples in considerably large terrains carried out over significant periods of time. Among the latter the  most important have been: the project carried out by the International Cooperative Biodiversity Groups (ICBGs), under the guidance of the University of Arizona with the collaboration of the Chilean Catholic University24; the program developed by the British Technology Group and the University of Chile, with the participation of the University of Southampton Agrochemical Unit, the Institute of Arable Crops Research, and the Royal Botanical Garden, and the program carried out by  in conjunction with the Japan International Cooperation Agency ()25. To a great degree, these three projects, at the time of their development, motivated the authorities responsible for environmental matters to politically approach the issue of genetic resources and their regulation. This led them to promote the development of a kind of regulatory instrument and policy to deal with the situations generated by these types of projects. As mentioned above, these projects have had a predominantly contractual basis, with a minimum or total lack of involvement of the environmental authorities, local communities, nongovernmental organizations (s), and indigenous groups. The majority of these projects have adopted the ’s general principles and rules in order to define their frameworks. Nevertheless, in practice, their development has generated a great deal of distrust, while the willingness of the parties involved to comply with these principles and rules has been questioned by various C : C sectors. The main criticism, apart from the lack of real participation, is related to the absence of clarity and certainty regarding the benefits owed to Chile or to its citizens in exchange for access to genetic resources. This lack of participation and transparency is not necessarily nor exclusively due to the unwillingness of those involved in the projects. Rather, it is due to the fact that the Chilean authorities responsible for environmental matters have been incapable of offering clear guidelines regarding the procedures to follow, the organizations to be consulted, the principles and rules to be respected, etc. This is mainly due to the absence of a framework that regulates genetic resources in Chile. Because of the absence of public sector regulations, private law has been applied, in all legitimacy, and the private interests of contracting parties have prevailed. Regarding organizations linked to the public sector, it is important to highlight the work of  in the contracting and development of bioprospecting projects. In compliance with its programs,  has subscribed to various contracts of access to genetic resources in Chile. Below we describe the fundamental aspects of two such contracts. It is important to emphasize that in both cases the parties recognize the sovereign rights of states over their own biological resources while making a commitment to comply with the contents and the spirit of , , and the national laws and regulations related to biodiversity, including access to plant genetic resources and their transfer. • Contract of Access to and Participation in the Benefits, signed by  and the Trustee of the Royal Botanical Garden, Kew, United Kingdom ( July ). Via this contract,  expressly awards its previously informed consent to the “Ex Situ Conservation of Endemic, Vulnerable, and Endangered Species from the Desert and Mediterranean Zones in Chile” project which is to be carried out by both institutions, according to the project summary attached in Appendix  of this contract. The main clauses of the contract refer to the following aspects: terms of transfer of col- lected material to the Royal Botanical Garden, Kew (Transfer Notification in Appendix  of the contract); a pledge of noncommercialization of transferred genetic resources, unless expressly agreed upon by the involved parties; a just and equitable distribution of the benefits; regulation of transfer of collected material to third parties (stipulated in an Appendix ); a pledge to treat confidential information in a confidential manner; and duration of the contract and conflict resolution. • Contract of Access to germplasm, signed by  and the C.M. Rick Tomato Genetics Resource Center (), of the University of California, Davis ( October ). Via this contract,  expressly grants its previously informed consent to the  to collect germplasm (seeds) samples from species and from places expressly indicated in the contract. The fundamental contents of the contract are as follows: the restriction of collection of material so as not to put the respective population in danger of extinction;  pledge not to claim property rights over the germplasm collected; equitable distribution of collected material between the involved parties; regulation of transfer of collected material to third parties; pledge to share information generated among parties involved;  pledges to assist  in increasing its technical capacities and genetic resource research; and conflict resolution. The differences between these contracts lie in the clauses that do not refer to the essence of the agreement (for example, duration of the contract, conflict resolution mechanisms, and future technical cooperation pledge). The essential elements are practically the same, consisting of: previously informed consent, declaration of equitable distribution of benefits, and regulation of the transfer of material collected to third parties. As these contracts are just starting to be implemented there is yet no information about their results. Conclusions As has been explained throughout this paper, to date Chile has not yet developed a structural framework for the general implementation of the , which would be a necessary base for specific formulation of an access and benefit distribution regime on the basis of objectives, goals, and priorities previously determined. However, the current National Biodiversity Strategy and the future National Biodiversity Action Plan are steps in the right direction. We have yet to see the results of the process leading to a National Biodiversity Action Plan, but it is certainly an approach that considers the integral and systematic implementaion of the . This process is being coordinated by  in its role as the authority in charge of proposing environmental policies to the government and as a national focal point for the . Regarding a strategy for the formulation of the access and benefit-sharing regime,  and the other institutions with some competence on the subject will have to consider the different formal systems by which the matter can be treated through a legal, contractual or voluntary approach. In addition, it will be necessary to decide whether to structure regulation through an integral formula (framework) or a flexible one (amendments to the existing legislation), of immediate or gradual development. The characteristics and the effectiveness of the legislative and institutional framework that regulates access to the genetic resources of each country will have a close relation to the process through which this framework is developed  A B  S  B and implemented. Once established, in order to operate efficiently the legislative framework must, at least, fit within the national strategy for the conservation and the sustainable use of biological diversity and be endorsed by institutional procedures with sufficient capacities for implementation. The effective formulation of a legal regime of access to genetic resources requires the participation of a high number of interest groups and experts. Governmental entities of different sectors must participate in the process as well as representatives of the scientific community and the private sector (for example, pharmaceutical and agricultural companies), local and indigenous groups, and s. The collective experience and the technical knowledge of all the sectors will not only benefit the legislative process, but also will help to identify any type of potential opposition to the legislation. When formulating the regulatory framework it is also important to have an integrated approach, so that the subject is not treated in an isolated manner. The regulatory framework at issue would have to be integrated within a broader set of policies and governmental activities. The discussion on how to regulate genetic resources would have to be carried out through a process of national planning, as required by Article  of the . A similar process offers the opportunity to gain important knowledge on the state and distribution of the biological diversity of the country, which is important to determine the more attractive geographic zones for the exploration of genetic resources and, in addition, to establish if the resources at issue are shared with other countries. Such a process also allows the establishment of wider objectives and national policies, while facilitating the evaluation of the existing institutions, laws, and policies. Since the regulation of access to the genetic resources is a new area of legislation, few countries have the necessary institutions and resources for its implementation. To develop this capacity requires a long-term process and, for that reason, it is vital to begin it as soon as possible. However, considering the elements mentioned before, it is clear that there are tensions between the urgent need to take measures and the complexity of the process. Evidently the  is a superstructure difficult to implement for developing countries, and Chile is a clear example of this difficulty. Throughout recent years there has been only erratic consideration of the subject, and it has never been considered a question of importance for the national interests, which is demonstrated by a clear lack of serious actions on the part of the political authorities. The subject is so difficult and complex that it is necessary to surpass the way in which these subjects are traditionally approached. The issue can be seen and treated from an ideal perspective or a practical perspective. The latter is able to diagnose and to recognize all the present difficulties and obstacles at stake to obtain the desired objectives and goals. We consider it advisable to follow a pragmatic approach to the subject in Chile, and to develop a process in a reasonable time frame with predetermined objectives, priorities, and goals. References A T. . Recursos genéticos terrestres nativos de Chile: Una propuesta para su conservación y uso sustentable. Temporada Agrícola :–. C  D. . Informe de la Comisión Permanente de Economía de la Cámara de Diputados, sobre el Proyecto de Ley de Propiedad Intelectual. Chile.  . Estudio de diagnóstico sobre la propiedad y el acceso a los recursos genéticos. Comisión Nacional del Medio Ambiente (), Chile, unpublished manuscript.  . Informe sobre recursos genéticos y el ordenamiento constitucional Chileno. Comisión Nacional del Medio Ambiente (), Chile.  . Propuesta de registro nacional de contratos de acceso a los recursos genéticos. Comisión Nacional del Medio Ambiente (), Chile. C A. and P. L. . Informe de la República de Chile para la . Chile.  G. L. and C. I. . Estado actual de la biotecnología en Chile. p. – in Proceedings of workshop Biotecnología en Chile: Oportunidades de Innovación Tecnológica. -Chile. I A. . Regulaciones al acceso a los recursos biológicos en Chile: Un desequilibrio entre flora y fauna silvestre. p. – in B. T T and G. M (eds.) Noticiero de Biología. Organo Oficial de la Sociedad de Biología de Chile. Taller Internacional: Aspectos ambientales, eticos, ideológicos y políticos en el debate sobre bioprospección y uso de recursos genéticos en Chile. . . Investigación, uso y protección de los recursos genéticos endémicos y nativos de Chile. Oficina de Estudios y Políticas Agrarias (), Ministerio de Agricultura, Chile. U  C. . Informe país: Estado del medio ambiente en Chile—. Centro de Análisis de Políticas Públicas. Chile. C : C Endnotes 1 In the case of the private sector there is no important development in this field. 2After the publication of Supreme Decree No. , , from the Ministry of Foreign Affairs, in the Official Journal,  May . 3 When set into practice, this national plan should be a significant element of the environmental policy of the country. 4 Consultants were hired to make a comparative study of national access legislation. This study was merely for updating the information available in  and was finished in March . It formulated some ideas for starting a new regulatory process in Chile, but its consequences and possible continuation are uncertain ( ). 5 This statement is given on the basis of a legal rule established by the Chilean Civil Code: “the accessory follows the principal or main thing”. This rule states that the owner of a good is entitled to ownership of any of its products or other things which constitute a unity with the original or main good (articles  to , Civil Code). 6 Those things that, being susceptible of appropriation, do not belong to anybody and which, therefore, any person can acquire the ownership of. Indeed, according to Chile’s Civil Code, the ownership of things that do not belong to anybody is acquired via use. Hunting and fishing are a type of use through which ownership of wild animals is acquired (Articles  and ). 7 For example, Law No. . on General Bases of Environment; Law No. . that creates the National System of Protected Wild Areas of the State; Law No. . for hunting; Law No. ., the General Law of Fishing and Aquaculture; Law No. . on National Monuments; Decree No. . on Agricultural Protection; and the Decree No. . on Acquisition, Administration and Disposition of Government properties. All these regulations will be mentioned in the following part of this paper. 8Alongside this permission, access will depend on the express authorization of the landowner. 9 This Service is in charge of wild fauna, according to its organic law. 10 The following are protected areas and other special zones: virgin area reserves, national parks, national reserves, natural monuments, nature sanctuaries, areas where hunting is prohibited, urban zones, railway tracks, airports, (in and from) public roads, places of scientific interest, and settlements of fertilizing wildfowl (Article  first paragraph of the Hunting Law). 11Article  of the Civil Code: “Plants are property if they adhere to the ground by their roots, unless they are in pots or boxes that can be moved from one place to another.” 12  is a private legal entity regulated by its own statutes, which must, among other functions, participate in the state management and development of forests made up of National Parks, Forest Reserves, and State Woods. That is,  must safeguard the natural patrimony in situ, within the protected wild areas and all forests. 13 Generally speaking, in compliance with its internal law, this Service must safeguard the conservation of agricultural flora. This means that it is not accountable for forest resources (under ) and wild flora (which is not currently under the express charge of any institution, apart from the regulations that correspond to protected wild areas). 14 This law is not yet in force since it is subordinate to the constitu- tion of  as a public institution, according to Law No. .. 15 Third clause of the agreement. 16 Fourth Clause of the Agreement. 17 Fifth Clause of the Agreement. 18 Sixth Clause of the Agreement. 19 Seventh Clause of the Agreement. 20 In compliance with  Resolution Nº,  August , the following functions are granted to the General Guardian of Plant Genetic Resources: the authority to plan, organize, co-ordinate, conduct studies of removal, collect plant genetic diversity, interchange germplasm, and assign a single serial and sequence number for each access agreement that enters the system; to participate in decision making related to quarantine, evaluation, characterization, classification, documentation, information diffusion activities, and adoption of the appropriate measures for conservation and sustainable use of plant genetic resources; and to act as consultant and member of the National Commission of Plant Genetic Resources. 21 Eighth clause of the agreement. 22Article , Law No. .: The following are not considered inventions and are excluded from this law’s patent protection:...b) plant material varieties and animal species. 23 Bill currently in process (Bulletin No. - Chamber of Deputies). 24 This project lasting five years, started in , under an agreement between the University of Arizona () and the Catholic University () with the purpose of preparing and supplying samples of biological material by the  to . Regarding benefit-sharing the agreement establishes that any royalties on the sale of compounds isolated from extracts of plants collected in Chile will be distributed in the following way: % of all royalties to a fund for conservation and for the benefit of local people in the country of collection; % of all royalties to the collector of the plant that is the source of the commercialized compound; and % of all royalties to the institutions employing those named as inventors on patents covering the commercialized compound. This project was renewed in  for another five years, and, according to the little information we were able to obtain, the main objective of this second phase was conservation rather than bioprospecting. The project ended in . 25 The Governments of Japan and Chile signed an agreement in  to develop, during the following five years, a program for the “Conservation of Genetic Resources” that would be implemented by  and . 