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Online Journal - URL: http://bioline.bdt.org.br/py The common regime on access to genetic resources in the Andean Pact Kerry ten Kate Environmental Strategies, Brook House, Crockham Village, Hampshire GU13 0SS, UK. E-mail: 100427.1056@compuserve.com Present address: Biodiversity Convention Officer, Convention and Policy Section, Herbarium, Royal Botanic Gardens, Kew, Richmond, Surrey, TW9 3AE, UK
Date received: January 29th 1997
Code Number: PY97006
Size of Files:
Text: 62K
No associated graphics filesCONTENTS
1.INTRODUCTION 2. ACCESS PROCEDURE 3. ACCESS CONTRACTS 4. SCOPE 5. STAKEHOLDERS 6. THE TERMS OF ACCESS AND BENEFIT-SHARING
7. THE EXTENT OF REGIONAL COOPERATION 7.2 Will benefits be shared between member countries? 8. NEXT STEPS 9. CONCLUSIONS 10. Acknowledgements 11. Endnotes 1. INTRODUCTION On 17 July 1996, the Cartagena Accord - commonly known as the Andean Pact - published Decision 391 in its Official Gazette (endnote 1). The Common Regime on Access to Genetic Resources ('the Common Regime'), the first subregional agreement of its kind, became legally binding forthwith in Bolivia, Colombia, Ecuador, Peru and Venezuela. This paper will review the objectives, scope and rules of the Common Regime on Access to Genetic Resources, highlight the more controversial provisions of Decision 391 ('the Decision'), and examine the challenges for the Member Countries and those who wish to gain access to their genetic resources.
1.1 THE ANDEAN PACT The Andean Pact (endnote 2) was established by the 1969 Cartagena Agreement, with the aim of promoting development in the member states through economic and social integration. An Andean Free Trade Area was implemented on 1 January 1992. The Commission of the Cartagena Agreement agreed to a Common External Tariff in November 1994, and a Customs Union has been in force since 1995. The March 1996 summit in Trujillo, Peru marked a watershed for the member countries. It modified the Cartagena Agreement, changed the group's name to the Andean Community and sanctioned reforms designed to accelerate integration and extend the group's agenda to cover political issues such as narcotics, corruption and terrorism. The new protocol to the Cartagena Agreement maintains the Presidential Council as the primary policy setting body on sub-regional integration; gives the Council of Foreign Ministers decision-making powers over implementation of integration; replaces the Junta del Acuerdo with a Secretary-General to head the Andean Community Secretariat following election for five years by the Council of Foreign Ministers; extends the mandate of the Andean Community Court of Justice to cover the issues introduced through the Trujillo modifications; and alters the constituency of the Andean Parliament. Hitherto consisting of representatives of the congresses of member countries, within five years members of the Andean Parliament will be elected by direct, universal suffrage. The Andean Pact Commission is the normative body of the Agreement, represented by the Bolivian Under-secretary of Foreign Relations for Integration Affairs and the Viceministers of Trade of the other countries. Although the Constitutions of the five members vary, decisions by the Commission are automatically binding on member countries, except in cases where a decision itself provides otherwise (endnote 3). At the Andean Presidential Summit held in Sucre, Bolivia in mid-April 1997, the Peruvian government announced its wish to withdraw from the Pact. A commission was appointed to discuss with Peru the conditions for its withdrawal from the group (endnote 4). The effect of Peru's withdrawal on the implementation of access legislation in Peru and implementation of Decision 391 by the remaining members remains to be seen. The likelihood is that Peru will develop its own access legislation that may follow a simpler model. 1.2 THE CONVENTION ON BIOLOGICAL DIVERSITY The Convention on Biological Diversity (CBD) provides the backdrop against which Decision 391 is set. Now ratified by 166 Parties, the objectives of the Convention are 'the conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies' (Article 1). Article 15 of the CBD concerns access to genetic resources. It recognizes the sovereign rights of States over their natural resources, and that the authority to determine access to genetic resources rests with the national governments subject to national legislation. Each Party to the CBD is to 'endeavour to create conditions to facilitate access to genetic resources for environmentally sound uses by other Contracting Parties and not to impose restrictions that run counter to the objectives of this Convention'. Access, where granted, shall be on mutually agreed terms subject to the prior informed consent of the Contracting Party providing such resources, unless that Party provides otherwise. Each Party is to endeavour to develop and carry out scientific research based on genetic resources provided by other Parties with the full participation of, and where possible in, such Parties. Finally, each Party is also 'to take legislative, administrative or policy measures . . . with the aim of sharing in a fair and equitable way the results of research and development and the benefits arising from the commercial and other utilization of genetic resources with the Contracting Party providing such resources'. While many countries have permit systems for collectors of genetic resources, few of these address the Convention specifically or require the sharing of benefits. Article 15 introduces a number of new challenges. Whose prior informed consent is required? What is a 'fair and equitable sharing of benefits' in different circumstances? What are the transaction costs of regulating access and ensuring benefit-sharing? Will access regimes streamline and facilitate access, or deter private sector interest? The Philippines and the five countries of the Andean Pact alone have introduced comprehensive regimes (endnote 5). Countries with drafts in progress, such as India and Brazil, and many others who are beginning to confront the issues are curious to see how Decision 391 will work in practice. Article 2 of Decision 391 sets out the objectives of the Common Regime on Access. The purpose of regulating access to the genetic resources of the member countries of the Andean Pact is to: (a) Create the conditions for fair and equitable sharing of the benefits accruing from such access; (b) Establish a basis for the recognition and appreciation of genetic resources, their derivatives and related intangible components, particularly where indigenous, afro-american and local communities are involved; (c) Encourage the conservation of biological diversity and sustainable use of biological resources containing genetic resources; (d) Promote the consolidation and development of scientific, technological and technical capacities at local, national and subregional level; and (e) Strengthen the negotiating capacity of the Member Countries. The broad effect of the Decision is to require collectors wishing to gain access to genetic resources within any of the five countries to follow a specific procedure, to apply for access to the 'Competent National Authority' (CNA) in the country where they wish to collect, and to enter into certain agreements.
2. ACCESS PROCEDURE The first step in the access procedure is for an individual or organization to apply to a Competent National Authority within the five Andean Pact countries for access to genetic resources of the country concerned. The application should contain identification of the applicant and documents demonstrating that he is legally entitled to enter into a contract; identification of the supplier of genetic or biological resources and their derivatives or of the associated intangible component; identification of the national support institution or individual; identification and curriculum vitae of the project manager and working group; the nature of the access activity being requested; the locality or area in which access will take place, and geographical coordinates. The application should be accompanied by a project proposal, which can be based on the reference model approved by the Board in the form of a resolution (Article 26). The model access application is contained in Resolution 414, and the model access contract in Resolution 415, both dated 20 July 1996. If the application and project proposal are complete, the CNA will declare the application admissible, provide a date for its presentation, and register it in its official and public records. (Article 27) If the application is found to incomplete it will be returned without further delay, indicating the missing information, so that it can be completed. Within five working days from registration in the public record, an extract of the application will be published in 'a written medium of social communication with a wide national circulation' and in 'another medium of communication in the locality where access activities are to take place', so that anyone wishing to do so may submit information to the Competent National Authority (Article 28). The Competent National Authority will evaluate the application within 30 working days of its registration, conducting any visits it may consider necessary and issuing a technical and legal report on the suitability or unsuitability of the project. The body has the discretion to extend this period to a maximum of sixty working days (Article 29). At this point, the Competent National Authority will either accept or reject the application, based on the results of the report, any visits, information supplied by third parties and compliance with the conditions specified in the decision. The applicant will be notified of acceptance within five working days of the decision and will then proceed to the negotiation and drafting of the access contract. If the application and project proposal are rejected, the decision will be communicated in the form of a resolution and the access procedure terminated, although the national legislation of each Member Country may provide for an appeal process (Article 30). Where the national legislation of a Member Country or the Competent National Authority requires it, the applicant must independently comply with any relevant environmental regulations, and complete the necessary procedures within the 30 or 60 day period stipulated above. The CNA may, however, grant an extension based solely on the time necessary to complete any necessary studies and submit them for consideration. A successful application will result in various access contracts, as described in the section 3, below. Flow chart of procedures required when applying for an access contract:
CNA = Competent National Authority
Application submitted to appropriate CNA
|
|
Application and Project proposal
|
________________________
| |
Application Application
complete incomplete
| |
Application declared Application returned with
admissible explanation about missing
- date for presentation given information (Art.27)
- registration in official
and public records (Art.27)
|
Extract of publication published
in high circulation national
publication and locally to proposed
access activities (Art.28)
|
CNA evaluates application within 30 days.
Possible extension to 60 days (Art.29).
Can be extended if studies of environmental
impact needed (Art.31)
|
____________________________________
| |
CNA accepts application. CNA rejects application
Applicant informed within 5 days pursuant to national law
(Art.30) (Art.30)
|
Access contracts negotiated
(Arts. 32-37)
|
Access contracts signed and published
in official journal and national newspaper (Art.38)3. ACCESS CONTRACTS Although the primary agreement is that between the applicant for access and the Competent National Authority (CNA), the Decision foresees three main kinds of agreement. The main access contract, between the CNA and the applicant, concerns genetic resources. An annexe contract between the applicant and the provider of the 'intangible component' is called for in certain circumstances where knowledge is transferred. Accessory contracts may be needed between the applicant and a range of institutions, concerned in activities involving biological resources. - Access contracts The applicant for access and the State, represented by the CNA will be party to an 'access contract', which must comply with the Decision and national law in the countries of the Andean Pact (Article 32). Furthermore, the access contract must 'take into consideration the rights and interests of suppliers of genetic resources and their derivatives, and of biological resources and their intangible components', in accordance with the other contracts mentioned below (Article 34). Article 6 provides that '[a]ny genetic resources and derivatives thereof, for which the Member Countries are countries of origin, are the property or patrimony of the Nation or State of each Member Country, as established by their respective internal legislation'. Consequently, it is only the State that has authority to grant access to the genetic component of biological resources. - Annexe to the access contract In cases when access is sought to genetic resources or their derivatives with an intangible component, the access contract shall include an integral annexe, providing for the 'fair and equitable distribution of the benefits' arising from the use of this intangible component (Article 35). The intangible component is defined as 'any knowledge, innovation or individual or collective practice of actual or potential value associated with the genetic resource, its derivatives or the biological resource containing them, whether or not it is protected by intellectual property systems' (Article 1). The Annexe is to be signed by the supplier of the intangible component and the applicant for access, and may also be signed by the CNA. Where the CNA is not a signatory, the annexe must include a 'suspensive' term making it subject to the access agreement. Failure to comply with such an annexe agreement is grounds for termination of the access contract. - Accessory contracts Where certain parties wish to develop activities connected with access to genetic resources (or their derivatives), the applicant for access may enter into an 'accessory contract' with: (a) The owner, holder or administrator of the property on which the biological resource containing the genetic resource is found; (b) The ex-situ conservation centre; (c) The owner, holder or administrator of the biological resource containing the genetic resource; or (d) The national support institution, in connection with activities which it is to carry out and which are not included in the access contract (Article 41). Three different kinds of accessory contracts are outlined in the Decision. a. Framework contracts A 'framework' contract may be established by a CNA with universities, research centres or recognized researchers, to support various projects to implement Decision 391 or related national legislation in the member countries (Article 36). This kind of agreement could be used either to deposit biological or genetic resources and their derivatives for purely custodial purposes, with the CNA maintaining jurisdiction and control over them, or for administrative purposes rather than for access, such as managing genetic resources, their derivatives or synthesized products (Fifth clause, Complementary Measures). b. Contracts with organizations involved with access Another kind of agreement is envisaged for certain institutions with activities closely related to access. 'Ex-situ conservation centres or other bodies carrying out activities involving access to genetic resources, their derivatives or, as applicable, their related intangible component, should sign access contracts with the Competent National Authority, pursuant to this decision' (Article 37). This provides an opportunity for the CNA to clarify the rights and obligations of such institutions, even with respect to collections obtained prior to the Decision and prior to the entry into force of the Convention on Biological Diversity.
c. Third party contracts
The final accessory agreement foreseen by the Decision is an access contract which 'may' be signed by the CNA and 'third parties' concerning those genetic resources deposited in ex situ collections and for which the member country 'is also the country of origin' (Article 37). The third party in such a case could likely be an ex situ collection outside the Andean region. The contract must take into consideration the rights and interests of suppliers, just as for access contracts. 4. SCOPE The Common Regime covers genetic resources as well as their derivatives and intangible components provided by Member Countries where they originate, and the genetic resources of migratory species found for natural reasons in the territory of the Member Countries (Article 3). Article 1 defines genetic resources as 'any biological material containing genetic information of actual or potential value', and the country of origin is defined as the country which possesses the genetic resources in in-situ conditions. The Decision is as interesting for what it excludes from its scope, as for what it includes. Human genetic resources, traditional use of genetic resources by communities, and use for 'biological' rather than 'genetic' purposes are excluded. Derivatives and the 'intangible component' are included, and so may be ex situ collections that pre-date the Decision and the Convention on Biological Diversity. - Human genetic resources Human genetic resources and their derivatives are excluded from the scope of the Decision (Article 4). This mirrors Decision II/11 (2) of the second meeting of the Conference of the Parties of the Convention on Biological Diversity held in Jakarta in November 1995, which 'reaffirms that human genetic resources are not included within the framework of the Convention'. The Parties to the Convention decided in Jakarta that the negotiators of the Convention could never have intended its provisions on access and benefit-sharing to apply to human genetic resources. The corollary of this decision, however, is that there is no international legal regime that regulates access to human genetic resources, for example by requiring the prior informed consent of people whose genetic material is sampled. Collections from indigenous communities continue within the Andean Pact, associated with the Human Genome Diversity Project. Regulation of this form of access is a matter to which the Andean countries may wish to give attention. - Traditional use by communities
Decision 391 also excludes from its scope, exchanges of genetic resources, their derivatives and the biological resources containing them, and the intangible components related to them, which take place between indigenous, Afroamerican and local communities for their own consumption, based on their traditional practices. The exclusion exonerates these communities from the legal and administrative duties imposed for other exchange. Since the exclusion is limited to exchanges for their own purposes, it should not be possible for unscrupulous individuals to use it to move genetic resources and associated knowledge from these communities into commercial circles without following the requirements set out in Decision. - Derivatives
Article 15 of the CBD refers only to access to 'genetic resources', which the Convention defines as any material of plant, animal, microbial or other origin of actual or potential value containing functional units of heredity. Decision 391, by contrast, includes not just the 'raw' genetic resources themselves, but 'derivatives'. A derivative is defined as 'a molecule or combination or mixture of natural molecules, including raw extracts of living or dead organisms of biological origin, derived from the metabolism of living organisms'. Since 'derivatives' thus defined may not include entire functional units of heredity, the scope of Decision 391 appears to go beyond that of the CBD itself. One effect is that collectors cannot avoid the prior informed consent and benefit-sharing obligations introduced by the Decision by simply extracting the genetic resources within the provider country and exporting substances that do not contain functional units of heredity. This aspect of the 'scope' of access provisions in Article 15 of the Convention on Biological Diversity has attracted much debate in its Conference of the Parties, since there remains room for interpretation of its provisions. Some countries, generally those likely to provide genetic resources, have argued that 'genetic resources' should include derivatives, whereas others, predominantly from countries that will import and use genetic resources, have argued, to the contrary, that biochemicals should not be included. Irrespective of interpretations of the CBD, its Parties are quite entitled, by virtue of their sovereignty over natural and genetic resources, as underlined in Articles 3 and 15.1 of the CBD, to introduce access legislation with a broader scope. The Andean Pact members have done so by explicitly incorporating derivatives in Decision 391. - Intangible component
The inclusion within the access requirements of the 'intangible component' - 'all knowledge, innovation or practice, individual or collective, with real or potential value, associated with a genetic resource, its derivatives or the biological resource which it contains, whether protected by intellectual property rights or not' - is equally controversial. The effect of introducing this provision is to subject access to traditional knowledge, such as ethnobotanical knowledge on the use of genetic resources, to the same procedures and requirements of access and benefit-sharing as for genetic resources themselves. Article 15 of the CBD deals only with access to genetic resources, and not to associated knowledge. It is Article 8 (j) that concerns the knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles. Subject to national legislation, Parties to the CBD are required to respect, preserve and maintain these, are encouraged to share the benefits arising from their use equitably, and to promote their wider application 'with the approval and involvement of the holders of such knowledge'. Decision 391 explicitly introduces this aspect into the legislation of the Andean Pact countries. - Use as a genetic resource
The activities that constitute 'access to genetic resources' are not defined in the CBD, and the nature of the use made of genetic resources is unspecified. Theoretically, the taking, for any purpose, of material containing functional units of heredity triggers the Convention's obligations on prior informed consent and benefit-sharing. However, commentators have been quick to suggest that the use envisaged by the CBD is limited to that which involves the genetic component of the resource, for example, bioprospecting, or plant breeding (see A Guide to the Convention on Biological Diversity, Lyle Glowka, Francoise Burhenne-Guilmin, Hugh Synge and collaborators, 1994, IUCN - The World Conservation Union, Environmental Policy and Law Paper No. 30). Otherwise, cropping plants for food or felling trees for timber (Endnote 7) would amount to access, and require prior informed consent and mutual agreement upon terms for benefit-sharing. Such a result, it is argued, can surely not have been intended by the negotiators of the CBD, and would impose an unnecessary formality upon countless non-genetic transactions. Decision 391 appears to support this interpretation. It defines 'biological resources' as 'individuals, organisms or parts thereof, populations or any biotic component with actual or potential value or use contained by the genetic resource or its derivatives', whereas 'genetic resources' are found in biological resources (Article 4(b)). They are the subset of biological resources 'containing genetic information of actual or potential value'. The rights and responsibilities introduced by Decision 391 distinguish between these two categories, and the uses made of each. Accessory contracts between the applicant and those with rights in biological resources are envisaged for these resources, whereas contracts between the state and the applicant are needed for genetic resources. Parties exporting 'biological resources' are required to mark on the accompanying phyosanitary certificates 'Not authorized for use as a genetic resource' (Clause four, complementary dispositions). - Ex situ collections The Decision defines 'country of origin' similarly to the definition in Art. 2 of the CBD, as the country which possesses those genetic resources in in- situ conditions, but departs from the CBD by explicitly including in this category those genetic resources which, having been established in in- situ conditions, are encountered in ex-situ conditions. The effect of this definition is not entirely clear, but is open to the interpretation that the scope of the Decision, and thus the application of its requirements for prior informed consent and benefit-sharing, apply not only to collections acquired after July 1996, when the Decision entered into force, but retrospectively, to collections acquired before the Decision and, indeed, before the entry into force of the CBD itself in December 1993 (Endnote 8). This would mean that the prior informed consent not only of the genebank or botanic garden in question, but also of the CNA (and other relevant stakeholders, as required by the various contracts outlined in section 3, above) would be needed prior to access to these collections. Two of the International Agricultural Research Centres (Endnote 9), much of whose germplasm is 'held in trust for the international community' (Endnote 10) are within the Andean Pact. A second implication of the Decision is that these international centres would need to follow the full access procedures for all their field activities. One expert from the region considers that this may be too much of a burden, and that the use of the resources could be more efficiently controlled on their supply from ex situ facilities (Endnote 11). Ex situ collections acquired before the CBD are excluded from its scope by Article 15(3), and are the subject of very complex and highly political international negotiations within the FAO's Commission on Genetic Resources and within the Convention on Biological Diversity. The legal and political implications of subjecting such collections to control by the national authorities of the country where they are housed would be considerable, and remain to be clarified. 5. STAKEHOLDERS It is clear from the range of contracts envisaged by Decision 391 that the countries of the Andean Pact view prior informed consent, mutual agreement of the terms of access and the fair and equitable sharing of benefits as a legitimate concern not only of the State, acting through its Competent National Authority, but of other stakeholders. The Decision refers to the following stakeholders:
The Convention itself is an international agreement between sovereign states. As such, the rights and responsibilities it introduces involve governments. However, the real players in access and benefit-sharing are the communities and institutions involved in day-to-day management, use and supply of genetic resources, and the companies with the technologies to develop and market products. The language of the Convention encourages their participation, but places the authority to regulate access firmly in the hands of government. Decision 391 marks an important development. It provides a framework at the national level for the involvement of a wide range of stakeholders in access determinations. All of those listed above have a role in determining, in specific circumstances, whether or not access takes place and the conditions of access. Of particular significance are the clauses conferring rights on indigenous peoples. Article 7 states that the Member Countries, in accordance with Decision 391 and their complementary national legislation, recognize and value the rights and decision-making capacity of indigenous, afro-american and local communities with regard to their traditional practices, knowledge and innovations connected with genetic resources and their derivatives. Such communities are defined in Article 1 as 'a human group whose social, cultural and economic conditions distinguish it from other sectors of the national population and which is wholly or partially governed by its own customs or traditions or by special legislation and which, regardless of its legal status, retains, wholly or in part, its own social, economic, cultural and political institutions'. Their interests are acknowledged in four major ways. - Condition for access contracts: Article 17(f) provides that applications for and contracts of access and, as applicable, any accessory contracts, shall include conditions such as the strengthening and development of their capacities with regard to the intangible components associated with genetic resources. - Rights and interests may be considered in access contracts: Article 34 requires the access contract to take into consideration the rights and interests of suppliers (who may include such communities) of genetic resources and their derivatives, and of biological resources and their intangible components. - Signatory to annexe to access contracts: Article 35 provides that the annexe to access contacts must be signed by the supplier of any intangible component. - Possible signatory to accessory contracts: Whether communities count as owners, holders or administrators of property or genetic resources (Article 41(a) and (c)) will depend upon their standing in national law in each Member Country. Where they do, certain activities connected with genetic resources may be covered by contracts with those accessing the resources. Furthermore, the Decision establishes a process for developing these rights. Within a year of the Decision's entry into force, namely by 17 July 1997, the Member Countries are to submit national studies, and within a further three months, the Board of the Cartagena Accord is to draft a proposal to establish a special system, or 'harmonization standard', to provide greater protection of the knowledge, innovations and traditional practices of indigenous, afro- american and local communities, pursuant to article 8 of the present decision, article 2A of International Labour Organisation (ILO) Agreement 169 and article 8(j) of the Convention on Biological Diversity (Clause eight, Interim Measures). The Member Countries are also to design a training programme for indigenous, Afro-American and local communities, to enhance their negotiating capacities in relation to intangible components, within the framework of access to genetic resources. (Clause nine, Interim Measures). 6. THE TERMS OF ACCESS AND BENEFIT-SHARING
As well as setting out the procedure that an applicant for access must follow, the Decision refers to substantive conditions for access to the genetic resources of the subregion, their derivatives and associated 'intangible components'. Article 17 states that 'Applications for and contracts of access and, as applicable, any accessory contracts, shall include conditions such as the following: (a) Participation by nationals of the subregion in research activities into genetic resources, their derivatives and associated intangible components; (b) Support for research contributing to the conservation and sustainable use of biological diversity being carried out under the jurisdiction of the Member Country which is the country of origin of the genetic resource, or in any other country of the subregion; (c) Strengthening of mechanisms for the transfer of knowledge and technologies, including biotechnologies, which are culturally, socially and environmentally safe and healthy; (d) Provision of information on antecedents, scientific progress or of any other nature likely to contribute to greater knowledge of matters relating to the genetic resource for which the Member Country is also the country of origin, its derivative or synthesized product and associated intangible component; (e) Strengthening and development of national or subregional institutional capacities connected with genetic resources and their derivatives; (f) Strengthening and development of the capacities of indigenous, afro-american and local communities with regard to the intangible components associated with genetic resources and their derivatives; (g) Obligatory deposit, in institutions designated by the Competent National Authority, of duplicates of all material collected; (h) Obligation to inform the Competent National Authority of the results of research carried out; (i) Terms under which material obtained may be transferred to third parties.' Such a list reveals the common desire to enter into partnerships enabling them to add as much value to their resources within their own country as possible. The emphasis is on joint research and technology transfer, and less on fee per sample or even percentage points of any future royalties. There are two major challenges for legislators drafting such clauses. The first is to find the correct balance between clear requirements and flexibility. Access legislation must alert applicants to the conditions for access to which they will be subject and the nature of their future obligations. It must clarify the 'basket' of benefits which the providing country is seeking in return for access. At the same time, the requirements must allow sufficient room for negotiation and enable the terms to be tailored to the specific circumstances of the parties on a case-by-case basis. The second challenge is to introduce a streamlined system with clear and reasonable requirements that will encourage collectors and industrial partners and not put them off. Both examples of national access measures that face this challenge are recent. Until there is more feedback from collectors, the national authorities in question and other stakeholders involved on the basis of experience of access applications in the Philippines and the Andean Pact, the jury is out on the extent to which the respective measures succeed (endnote 6). The language in Article 17 of Decision 391 does give prospective parties to access agreements room to manoeuvre. The words 'conditions such as . . .' suggest that the list is indicative, providing guidance to applicants and a basis for negotiations, but leaving the final terms up to the CNA and other parties to the contracts described above on a case-by-case basis. 7. THE EXTENT OF REGIONAL COOPERATION Two main questions arise with respect to the extent to which member countries will act in concert to implement Decision 391. Does Decision 391 allow member countries to influence each others' access determinations to prevent them undercutting each other? And will benefits derived from the use of one member country's genetic resources or associated intangible component be shared with beneficiaries in all member countries, if the genetic resource or intangible component is found in more than one member country? 7.1 Influence of member countries over each others' access determinations. One of the objectives of the Common Regime is to strengthen the negotiating capacity of the member countries. An important component of this will be to prevent member countries from undercutting each other through the conditions they require of applicants for access. To accomplish this aim, both substantive and procedural requirements would be needed in Decision 391 whose effect would be twofold: to provide other member states with information on applications for access before access was granted, and to allow feedback from the other member states to influence the outcome. What does Decision 391 say on these issues? There are three kinds of provision in Decision 391 of relevance to member countries' influence over each others' access determinations: those concerning notification, that on consideration of other member countries' interests, and those on future cooperation. - Notification Article 48 requires member countries to notify each other immediately, through the Board of the Cartagena Accord, of 'all applications, resolutions and authorizations of access and of the suspension and termination of contracts signed'. This brief provision makes clear that the requirement to notify extends beyond information concerning decisions they have already been made, for example final determination of access contracts, and includes all applications for access. Article 48 and Articles 26-31 on the procedure for access are silent on the point during the access proceedings at which information on applications for access must be provided to other member countries. The information could, therefore, be available to other members before access is granted, so that the possibility arises for other member countries effectively to provide their 'prior informed consent' before any one member makes an access determination. However, Decision 391 does not state this explicitly. There is no time requirement, so members are strictly entitled to inform each other of the application after the access contract has been agreed. Furthermore, the Article does not stipulate the nature and extent of information to be provided, for example, whether information given 'confidential treatment' under Article 19 would be shared with other Competent National Authorities. The other countries may be provided with insufficient information on the proposed terms of the access agreement for their consent to be 'informed'. The second clause in Article 48 requires members to notify each other of any bilateral or multilateral agreements on access that they have signed in relation to the subject. The clause does not require such notification of the proposed measure to be prior to entering into agreement, although it does require all such agreements to comply with Decision 391, and must therefore be read in conjunction with the second clause of the Final Measures (below). Again, Article 49 requires member countries immediately to inform each other of 'measures, decisions, regulations, decrees, resolutions and other standards or acts with any bearing on the present decision' adopted internally. This broadens the range of activities which must be notified, but does not stipulate that notification must be prior to agreement to the activities. Two other provisions require members to establish mechanisms to exchange information and thus to implement the notification obligations. The Andean Committee is to recommend mechanisms for the establishment of an Andean information network on access requests and contracts in the subregion (Article 51 (c)), and the Competent National Authority and national offices handling intellectual property matters are to establish systems for exchanging information on authorized access contracts and concessions of intellectual property rights (clause 3, complementary measures). - Consideration of other member countries' interests Procedural requirements such as those for notification described above are of little weight without an obligation to take the information conveyed into consideration when making the access determination. The second clause of the Final Measures of Decision 391 requires the Competent National Authority 'to take into account the interests of other Member Countries' when negotiating the terms of contracts providing access to genetic resources or their derivatives for which more than one Member Country is a country of origin, and in carrying out related activities. The other member countries concerned 'may present their views and whatever information they deem most relevant'. This is the strongest indication in Decision 391 of the need to take into consideration other countries' views, but falls short of providing them with the right to influence the outcome in specific ways, for example through specifying terms or vetoing access. Furthermore, the interests of other stakeholders must also be taken into consideration. Although the presumption of Art.18 is that the majority of details concerning access applications will be on record and open to public scrutiny, Art 19 concerns confidentiality. Upon presentation of a petition by the applicant, the Competent National Authority 'may give confidential treatment to any information or data which it receives in connection with the access procedure or contract execution which has not been divulged and could be used for disloyal commercial purposes by a third party, except when public knowledge of the same is necessary in order to protect social interests or the environment'. The CNAs may choose to treat each other as trustworthy collaborators in whom confidences can be reposed. On the other hand, concern that information might be used for 'disloyal commercial purposes' outside national jurisdiction might prevent CNAs from sharing such confidential information with each other. - Future cooperation Rather like the Convention on Biological Diversity, the Common Regime is not just a static treaty that has been agreed, but an evolving process. Article 10 declares that the member countries will define mechanisms for cooperation on matters of mutual interest related to the conservation and sustainable use of genetic resources and their derivatives and intangible components, thus providing the overarching mandate for further work, which could further definition of mutual agreement on access and benefit-sharing. Article 51 creates an Andean Committee on Genetic Resources, comprising the directors of the Competent National Authorities on access to genetic resources, or their representatives, advisors, and representatives of other sectors concerned, as designated by each Member Country. Among its responsibilities are the promotion of 'actions to manage, monitor, control and supervise authorizations of access to genetic resources and their derivatives found in two or more Member Countries' (Art.51(f)) and cooperative action on 'matters relating to genetic resources or their derivatives' (Art.51(h)). Finally, the Board of the Cartagena Accord may, based on a resolution and prior opinion from the Andean Committee, perfect or adjust by resolution the access procedures described in section 2. Closer cooperation between member countries is envisaged, especially in the case of resources common to more than one member country. 7.2 Will benefits be shared between member countries? Although there is currently no provision on the 'multilateral' sharing of benefits arising from use of genetic resources acquired in one member country among all five members, there is room in the substantive and procedural requirements in Decision 391 to establish mutual benefit-sharing in the future. Indeed, this is a likely focus for the Andean Committee's actions on common resources. Furthermore, funding mechanisms, including funds 'based on the benefits arising from access' are envisaged. At the national level, these will be run by the Competent National Authority with the aim of promoting compliance with Decision 391 Authority. The members will also assess the feasibility and appropriateness of creating an Andean Fund for the conservation of genetic resources (first clause, Complementary Measures). Although this fund is intended to support conservation rather than to operate as a mechanism to disburse benefits, it could be used to direct funds arising from the use of genetic resources common to more than one member of the Pact. 8. NEXT STEPS Decision 391 became binding on the members of the Andean Pact when it was published in July 1996. However, the member countries are introducing national legislation to match or develop national law on the rights and responsibilities of the stakeholders referred to in the Decision, to create and identify their Competent National Authorities (which have a broad range of functions set out in Article 50), and to clarify other procedural and administrative aspects. Ecuador has already passed brief legislation related to access (endnote 12) and designated INEFAN as its competent national authority. A Peruvian law was to have been ready within the next few months, although the withdrawal of Peru from the Andean Community and consequent need to regulate access independently may delay finalisation of the legislation. Colombia and Venezuela are also working on national measures. The genetic resources unit of the Bolivian Ministry for Sustainable Development and Environment is working on draft Regulation on Access to Genetic Resources and a National System for the Conservation and Development of Bolivian Genetic Resources (Sistema Nacional de Conservacion y Desarrollo de Recursos Geneticos de Bolivia (endnote 13). At the regional level, the Andean Committee on Genetic Resources, comprising the directors of the Competent National Authorities and representatives of other sectors concerned, will meet to work on a number of issues, such as compliance with the Decision, information networks, common models for documentation, and how to manage access to resources found in more than one member country.
9. CONCLUSIONS The countries of the Andean Pact are in the vanguard of the many likely to introduce national measures on access and benefit sharing. Few have yet done so, and experience applying the recent legislation in the Andean Pact and the Philippines is only just beginning to emerge. It is too early say whether the Common Regime will facilitate access to the satisfaction of the key stakeholders in the countries themselves and of companies and institutions around the world seeking access to Andean biodiversity. The introduction of a Competent National Authority in each member country should simplify matters for applicants for access, who often need to approach a number of different government departments. The clear procedures introduced by the Regime should reduce confusion and the element of doubt that frequently troubles collectors around the world. Time will tell whether prospective users of genetic resources find the conditions for access too onerous. Article 17 has the merit of setting out expectations, and, provided it is applied flexibly in each country, should meet a range of needs and allow room for negotiation and mutual agreement. The provisions on scope, stakeholders and the different agreements foreseen go some way to clarifying the ambiguity of related articles in the Convention on Biological Diversity. While these are encouraging signs, the member countries of the Andean Pact still face many intellectual, legal and management challenges as they develop and implement Decision 391 at the national and sub-regional levels. The first of these is to implement the basic requirements at the national level. The fundamental challenge is to regulate access in such a way as to secure a fair and equitable share of benefits and to conserve biological diversity, but at the same time to facilitate access on reasonable terms through a stream-lined and manageable procedure. Overly bureaucratic procedures and demands for monetary and non-monetary benefits significantly above the 'market price' will inevitably mean that applicants for access turn to other countries, or even turn away altogether from the use of newly accessed biodiversity in research and development. This is something to be borne in mind by the Andean Pact members as they devise national rules, since Decision 391 is already intricate, requiring prior informed consent from several stakeholders, the negotiation of main, annexe and accessory contracts at the community and institutional level, and the sharing of several kinds of benefit. Once these considerable challenges have been met, perhaps the hardest task for the Andean countries would be to develop a regime for sharing benefits across the sub-region for common genetic resources. The recent announcement by Peru of its intention to withdraw from the Pact and the negotiating history of Decision 391 attest to the difficulty of reaching sub-regional agreement. Feedback from interested observers around the world - whether collectors interested in access to Andean genetic resources or other countries beginning to tackle the complex issue of access and benefit-sharing - will be invaluable, both for the Andean Community and the growing band of people involved in designing and implementing access measures. ACKNOWLEDGEMENTS I would like to thank Jorge Mariaca and Alvaro Luna, Beatriz Zapata and Daniela Osorio of DNCB for their hospitality in La Paz, their patience with my questions and Spanish and willingness to exchange ideas. Antonio Matamoros of INEFAN and Joe Vogel from Ecuador, and Manuel Ruiz of the SPDA and Jorge Castro of the Andean Commission in Peru went out of their way to provide information and discuss interpretation. Noel McGough and Jacqui Roberts of the Royal Botanic Gardens, Kew kindly read earlier drafts. Without these contributions, this article would never have happened. Errors that remain are entirely my responsibility. ENDNOTES Endnote 1: Comision del Acuerdo Cartagena: 1996. Decision 391: Regimen Comun sobre Acceso a los Recursos Geneticos. Gaceta Oficial, Ano XII - Numero 213, Lima, 17 de julio de 1996. Endnote 2:
For more information on the Cartagena Agreement and the Andean Community, contact:
Junta del Acuerdo de Cartagena Endnote 3: Personal communication, 25 April 1997, Lic. Jorge Castro, Legal Counsel, Andean Commission. Endnote 4: Personal communication, 25 April 1997, Lic. Jorge Castro, Legal Counsel, Andean Commission. Endnote 5: Presidential Executive Order No. 247, "Prescribing Guidelines and Establishing a Regulatory Framework for the Prospecting of Biological and Genetic Resources, their By-Products and Derivatives, for Scientific and Commercial Purposes, and for other Purposes", Department of Environment and Natural Resources, Manila, Philippines. When the other major measure on access was introduced in the Philippines (endnote 1) in May 1995, there was considerable interest in the section setting out the 'Minimum Terms of the Commercial Research Agreement and Academic Research Agreement' required by the Order. Endnote 6: Minimum Terms of the Commercial Research Agreement and Academic Research Agreement (Section 5). The analogous conditions set by the Philippine Government in its executive order on access are: (a) There must be a limit on samples that the Commercial/Academic Collector may obtain and export and that the approved list and amount of the samples taken from the area must be followed strictly. (b) A complete set of all specimens collected shall be deposited by the Commercial/Academic Collector with the National Museum or a duly designated governmental entity; Provided that holotypes designated by the author must be maintained at the National Museum. (c) Access to collected specimens and relevant data shall be allowed to all Filipino citizens and the Philippine governmental entities whenever these specimens are deposited in depositories abroad. (d) The Commercial/Academic Collector, or in appropriate cases, its Principal, must inform the Principal Government as well as the affected local and indigenous cultural communities all discoveries from the activity conducted in the Philippines if a commercial product is derived from such activity. (e) The agreement shall include a provision for the payment of royalties to the National Government, local or indigenous cultural community and individual person or designated beneficiary in cases commercial use is derived from the biological and genetic resources taken. Where appropriate and applicable, other forms of compensation may be negotiated. (f) There shall be a provision allowing the Philippine government to unilaterally terminate the agreement whenever the Commercial/ Academic Collector has violated any of its terms. The Agreement may also be revoked on the basis of public interest and welfare. (g) A status report of the research and the ecological state of the area and/or species concerned shall be submitted to the Inter-Agency Committee regularly as agreed upon. (h) If the Commercial Collector or its Principal is a foreign person or entity, it must be stipulated that scientists who are citizens of the Philippines must be actively involved in the research and collection purposes and, where applicable and appropriate as determined by the Inter-Agency Committee, in the technological development of a product derived from the biological and/or genetic resources taken from any area in the Philippines. This involvement shall be at the cost of the Commercial Collector. (i) The Commercial Collector and/or its Principal shall be encouraged to avail of the services of Philippine universities and academic institutions. Where applicable and appropriate, the Commercial Collector and/or its Principal shall be required to transfer equipment to a Philippine institution or entity. (j) A fixed fee must be paid to the DENR in accordance with a schedule of fees formulated by the Inter-Agency Committee. (k) The maximum term for a Commercial Research Agreement shall be for three years and renewable upon review by the Inter-Agency Committee. (l) In case of endemic species, there must be a statement that the technology must be made available to a designated Philippine institution and can be used commercially and locally without paying royalty to the Collector or Principal. Provided, however, that where appropriate and applicable, other agreements may be negotiated. Provided, further, that the following terms shall be considered in an Academic Research Agreement: (m) The Academic Research Agreement may be comprehensive in scope and cover as many areas as may be projected. It may stipulate that all scientists and researchers affiliated with a duly recognized university, academic institution, governmental and inter-governmental entity need not apply for a different Research Agreement but may conduct research and collection activities in accordance with an existing Academic Research Agreement. In such cases, the university, academic institution and governmental entity shall ensure that all the terms and conditions of the government are complied with by the affiliated scientist or researcher. In all cases, the university institution or governmental entity must ensure that affected communities have given their prior informed consent to the activities to be undertaken; (n) There must be a provision requiring the Academic Collector to apply for a commercial research agreement when it becomes clear that the research and collection being done has commercial prospects; (o) A minimal fee must be paid to the Philippine government in accordance with a schedule of fees by the Inter-Agency Committee; and (q) The maximum term for an Academic Research Agreement shall be for five years and renewable upon review by the Inter-Agency Committee. Endnote 7: I.e. harvested material rather than propagating material, in the UPOV sense. See Article 15, International Convention for the Protection of New Varieties of Plants, 1991. Endnote 8: The CBD entered into force on 29 December 1993 after ratification by 30 Parties. Subsequently, it enters into force in each country 90 days after deposit by the State of its instrument of ratification, acceptance or approval with the Secretary-General of the UN. The relevant dates in the Andean Pact are as follows:
Bolivia 3.10.94 Endnote 8: The International Potato Centre, CIP, is in Peru, and CIAT is in Colombia. Endnote 9: See the terms of the FAO/CGIAR Agreement, 26 October 1994. Endnote 10: The Centro Internacional de la Papa (International Potato Centre - CIP) is in Peru, and the Centro Internacional de Agricultura Tropical (International Tropical Agriculture Centre - CIAT) is in Cali, Colombia. Endnote 11: Personal communication with Lic. Manuel Ruiz, Sociedad Peruano de Derecho Ambiental, Lima, Peru. Endnote 12: See UNEP/CBD/COP/3/20, on Linkages WWW Site Mini Ley: 2 septiembre, 1996, Quito. Endnote 13: Ministerio de Desarollo Sostenible y Medio Ambiente, Direccion Nacional de Conservacion de la Biodiversidad (DNCB), 1997: Proyecto de Reglamentos de la Decision 391: Regimen Comun de Acceso a los Recursos Geneticos Ministerio de Desarollo Sostenible y Medio Ambiente, Direccion Nacional de Conservacion de la Biodiversidad (DNCB), 1997: Establecimiento del Sistema Nacional de Conservacion y Desarrollo de Recursos Geneticos de Bolivia Copyright remains with the author Published by Bioline Publications, UK
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