National Taipei University. From the SelectedWorks of Kuei-Jung Ni. Kuei-Jung Ni, National Chiao Tung University. March 27, 2008

National Taipei University From the SelectedWorks of Kuei-Jung Ni March 27, 2008 Legal Aspects of Prior Informed Consent on Access to Genetic Resources: An Analysis of Global and Local Implications towards an Optimal Normative Construction Kuei-Jung Ni, National Chiao Tung University Available at: https://works.bepress.com/kuei_jung_ni/1/

Legal Aspects of Prior Informed Consent on Access to Genetic Resources: An Analysis of Global and Local Implications towards an Optimal Normative Construction Kuei-Jung Ni Contents I. Introduction: The Consolidation of International Movements to Control Genetic Resources II. III. The CBD and Subsequent Law-making of PIC on Genetic Resources Access A. The Origin of PIC and its Incorporation in International Environmental Rules B. The CBD and Bonn Guidelines C. The Proposed International Regime 1. An Overview of the Regime to Enforce PIC 2. A Critique of the Regime s Preliminary Design of PIC National Practices of Genetic-resource Rich Countries on PIC Requirement A. India B. Brazil C. The Philippines D. Costa Rica E. Peru Associate Professor of Law, Institute of Technology Law, National Chiao Tung University, Taiwan. Email: kjni@mail.nctu.edu.tw. PhD in law, University of Edinburgh, 2000; LL.M, University of California at Berkeley, 1995; LL.M, Institute of the Law of the Sea, National Taiwan Ocean University, 1992; LL.B, Department of Law, National Taiwan University, 1986. An earlier draft of this article was presented at the Symposium on Survey and Research on Genomic Orientation in Taiwan, organized by the Center for Survey and Research, Academia Sinica in Taipei, Taiwan on May 10, 2006. This article was supported by a grant from the National Science Council of the Republic of China (Taiwan). (NSC 94-2414-H-009-001-; NSC 95-2414-H-009-001-). Part of the research was delivered at a seminar held at the School of Law, University of Edinburgh, on Aug. 23, 2007. The author is grateful to the Royal Society of Edinburgh for sponsoring the seminar. The author thanks Yen-Chun Lee for his helpful research assistance. The author also benefits from Kaylar Kingdon-Bebb s brilliant editing work. 1

F. Taiwan IV. Critical Issues Occurring in PIC Practice: Overall Assessment and Suggestions A. The Role and Status of Indigenous Peoples in Access to Genetic Resources B. Multi-consent System of PIC: Troubled Waters? and the Problem of Anti-commons C. Reshaping the Function and Role of Competent National Authority V. Conclusion Abstract Since the Convention on Biological Diversity (CBD) was in force, national implementation of the access to and benefit-sharing (ABS) requirement on genetic resources has been flourishing. Prior informed consent (PIC) of the ABS constitutes a major means to deter illegal bio-piracy and to ensure fair access to genetic resources. Given the differential social structure in individual nations, there seems to be no consistent pattern of PIC domestically. Some legislatures recognize the decisive role of indigenous or local communities in the context of enforcing PIC, making access to genetic resources impossible without their consent. On the other hand, several central governments dominate the PIC process so as to make the will of local people relatively marginal. This article aims to analyze the global implications of the concept of PIC and to conduct a comparative study on how genetically-rich nations implement the PIC requirement locally with a view to examining whether the genuine objective of the CBD has been fulfilled. The task involves an analysis of legal arrangements and implications in several leading models of legislature. This article argues that the will of indigenous peoples should be properly respected regardless of whether they may exercise the consent right on GR access. Further, national operation of PIC should be under effective international supervision to prevent the misuse or abuse of PIC and to ensure its implementation is in conformity with the objectives of the CBD. 2

I. Introduction: The Consolidation of International Movements to Control Genetic Resources The Convention on Biological Diversity (CBD) 1 provides that genetic resources (GR) originate in plants, insects, animal or microbial. 2 As a result, human genes are practically excluded from the context of GR. Nowadays, the value and significance of genetic resources (GR) has appeared increasingly prominent, playing a significant role in the spheres of agriculture, bio-industries, medicine and the global economy. 3 Notably, the modern biotechnology industry substantially relies on bioresources to produce commercial products. 4 Prior to the adoption of the CBD, there had been an appeal of placing GR under international control. In effect, the benefits of GR might be available or accessible to all humankind instead of being dominated by each sovereign nation alone. The movement to classify GR as international common property was initialized by an international institution; the primary effort of the United Nations Food and Agriculture Organization (FAO) in preserving agricultural genetic resources 1 The Convention on Biological Diversity, adopted June 5, 1992, in force Dec. 29, 1993 [hereinafter CBD]. 2 The CBD defines GR as genetic material of actual or potential value, and considers genetic material to be any material of plant, animal, microbial or other origin containing functional units of heredity. Id. art. 2. 3 See generally GRAHAM DUTFIELD, INTELLECTUAL PROPERTY RIGHTS, TRADE AND BIODIVERSITY 1 (2000)[hereinafter INTELLECTUAL PROPERTY RIGHTS]. GRAHAM DUTFIELD, INTELLECTUAL PROPERTY, BIOGENETIC RESOURCES AND TRADITIONAL KNOWLEDGE 18-20 (2004)[hereinafter BIOGENETIC RESOURCES]. MITSUO MATSUSHITA ET Al., THE WORLD TRADE ORGANIZATION: LAW, PRACTICE AND POLICY 413 (2003). 4 Michael I Jeffery, Bioprospecting: Access to Genetic Resources and Benefit-Sharing under the Convention on Biodiversity and the Bonn Guidelines, 6 SING. J. INT L & COMP. L. 747, 754-55 (2002). 3

represents a leading model. The International Undertaking on Plant Genetic Resources 5 adopted in 1983 specifies that the Undertaking is based on the universally accepted principle that plant genetic resources are a heritage of mankind and consequently should be available without restriction. 6 In its earlier stage, the text aimed to ensure the interests of GR not to be monopolized by private sectors, but should benefit all humans. 7 The original design of GR as a part of common heritage of mankind (CHM) would help reduce national control on GR, and thus make the resources more easily accessible. 8 Irrespective of the idealism of equating GR with CMH, it is hard to vindicate the universal prevalence of the move, particularly in light of current developments. First of all, the Undertaking, a soft law nature, is not a legally binding instrument. Secondly, such a notion of considering GR as CHM has hardly been practiced by either developed or developing nations. The developed countries had initially made reservation to the idea promoted by the Undertaking. 9 It is also clear that the doctrine 5 The International Undertaking on Plant Genetic Resources, Annex to Res. 8/83, Report of the Conference of the FAO, U.N. Food and Agriculture Organization, 22 nd Sess., Rome, Nov. 23, 1983, U.N. Doc. C/83/Rep., available at http://www.fao.org/ag/cgrfa/iu.htm (last visted May 15, 2007). [hereinafter Undertaking]. 6 Id. art.1. 7 Jeffery, supra note 4, at 758 n.58 (further observing the failure of the Undertaking to achieve its primary purpose). 8 Atul Kaushik, The Indian Experience in the Field of IPRs, Access to Biological Resources and Benefit Sharing, in TRADING IN KNOWLEDGE: DEVELOPMENT PERSPECTIVES ON TRIPS, TRADE AND SUSTAINABILITY 256 (Christophe Bellmann et al. eds., 2003); see also Sabrina Safrin, Hyperownership in a Time of Biotechnology Promises: The International Conflict to Control the Building Blocks of Life, 98 AM. J. INT L L. 641, 644-45 (2004). 9 Safrin, supra note 8, at 644 n.15. 4

of global genetic commons is no longer honored even by the developing world. Rather, the latter has already been inclined to argue that GR should be under sovereign domain and to favor a strong and effective national regulation of GR access within individual territories. 10 Third, the global commons of GR would meet with difficulties in its management. Given that most GR, apart from those located under the High Sea, 11 are within certain countries boundaries, the internationalization of GR would definitely encounter resistance from GR-providing nations. As the idea of global genetic commons seems obsolete and no longer effective, there has been a growing tendency to shift the global commons approach to the sovereign dominance approach during the past decades. In particular, developing countries continue to voice intolerance and resentment towards bio-piracy or misappropriation of their GR. 12 They consider a tighter GR access regulation and fair benefit-sharing to be essential in preventing the injustice of bio-piracy and to assure equity in bioprospecting. Apparently, the conclusion of the CBD in 1992 had echoed the call for a proper control on GR mainly by requiring a fair and equitable sharing of GR interests as one of its three objectives. 13 Concerning the authority and competence to regulate GR 10 Jeffery, supra note 4, at 759. 11 According to Article 136 of the U.N. Convention on the Law of the Sea, the status of the deep sea bed under the High Sea amounts to CHM. 12 Biopiracy means the unauthorized, uncompensated removal of genetic resources from a source country. See Jeffery, supra note 4, at 757 & n. 53. Developing countries have endeavored to revoke bad patents that were granted as a result of biopiracy. See generally DUTFIELD, INTELLECTUAL PROPERTY RIGHTS, supra note 3, at 65-67; see also Kuei-Jung Ni, The Incorporation of the CBD Mandate on Access and Benefit-sharing into TRIPS Regime: An Appraisal on the Appeal of Developing Countries with Rich Genetic Resources, 1 ASIAN J. WTO & INT L HEALTH L. AND POL Y 433, 437-38 (2006). 13 CBD, supra note 1, art. 1. The other two objectives of the CBD include the conservation of biological diversity and the sustainable use of its components, see id. 5

access, the CBD confers power to contracting parties while reaffirming the sovereign rights of States over GR. 14 Though the skepticism toward the CBD mandate remains, 15 the sovereign control of GR is arguably a reflection of customary international environmental law. 16 Further, given the worldwide accession to the CBD 17 and the irreplaceable function of national governments in this regard, national authority has already played a governing role in regulating GR. More importantly, the CBD stipulates the regime of access to and benefit-sharing (ABS) of GR 18. The requirement of prior informed consent (PIC), originating from a medical discipline between doctors and patients, 19 is incorporated into ABS. The 14 CBD, supra note 1, art.15 (1). 15 See generally Safrin, supra note 8, at 647-48. 16 It has become a customary rule of international environmental law that States are entitled to claim sovereign rights on natural resources within their jurisdiction. See PATRICIA BIRNIE & ALAN BOYLE, INTERNATIONAL LAW AND THE ENVIRONMENT 112-14 (2d ed. 2002). Numerous international documents on the environment have confirmed the rule. For instance, 1972 Declaration of the UN Conference on the Human Environment, Principle 21; 1992 Rio Declaration on Environment and Development, Principle 2; 1982 United Nations Convention on the Law of the Sea (UNCLOS), article 56, 77, which explicitly recognize the sovereign rights of States on their Exclusive Economic Zone and Continental Shelf. 17 As of May 2007, the CBD had 190 contracting parties. See CBD website: http://www.biodiv.org/world/parties.asp (last visited May 15, 2007). However, the USA and Taiwan are the only two major nations that are non-contracting parties to the CBD. 18 Since the adoption of the CBD, the CBD has set up an Ad Hoc Open-ended Working Group to address the detailed content of ABS with a view to strengthening ABS function. See CBD website at: http://www.biodiv.org/programmes/socio-eco/benefit/default.aspx (last visited May 15, 2007). Nowadays, the ABS regime in general has been implemented by many countries as a useful mechanism to maintain fair and equitable access to GR and to deter bio-piracy. 19 See discussion infra Part II, A. 6

functioning PIC that obliges GR users to seek consent from GR providers before accessing the GR in question may help terminate the bio-piracy and unchecked bioprospecting that pays no respect to the free will of GR providers. The mechanism can also be a major means to ensure fair access to GR. Presently, PIC embodied in most national legislatures constitutes a core element and condition in approving applications for GR access. 20 It should be noted that a variety of national and international stakeholders may have a strong linkage with GR access. Therefore, it is essential to take into account their interests in implementing the PIC mandate. As local GR providers, indigenous peoples and local communities should be allowed to voice their concerns on any access project as GR in their territories usually are integral components in their traditional life and culture. 21 Bio-prospecting researchers and companies as GR users may have the justification to explore GR simply because the value of GR can hardly be dismantled or commercialized without the assistance of advanced bio-technology. 22 In effect, they may assert that the freedom of bio-prospecting and research should be recognized, and they disdain unnecessary restrictions on GR exploration. 23 Of course, 20 See discussion infra Part III. 21 See Jeffery, supra note 4, at 791. 22 See id. at 790 (mentioning that industry constitutes the driving force of creating profits arising from using genetic resources). Apart from bioprospecting activities, the disclosure of individual GR significance involves many scientific stages including sampling, screening, extracting, testing, undertaking clinical trials and other steps involving bio-technology. See id. at 755-57 & n.51. 23 There is growing criticism from scientists and academic researchers regarding the increasingly tight control of GR by national governments. See Andrew C. Revkin, Biologists Sought a Treaty; Now They Fault It, N. Y. TIMES, May 7, 2002, at Sec. F, p.1, col. 3. Jeffery points out that States may unduly restrict genetic resources access for scientific research because of worry about the exploitation of state resources for commercial purposes. See Jeffery, supra note 4, at 793. 7

as major and dominant GR providers, State governments may consider themselves indispensable actors in regulating activities under their jurisdiction, including exploration of GR. 24 In practice, as political and social structures in individual nations differ, there seems to be no entirely consistent or similar PIC pattern. Some legislatures recognize the decisive role of indigenous or local communities in the operation of PIC, making access to GR impossible without their genuine consent. On the other hand, to ensure access process more effectively, several central governments largely dominate a PIC process so as to make the will of local peoples relatively marginal or simply so as to treat their determination only as a reference for the granting of final consent. The differential practices have drawn criticism and complaint from scholars, researchers, and GR users. Some appear skeptical of an overly burdensome PIC procedure that could make a well-proposed bioprospecting project collapse unreasonably. 25 The neglect of local voices by national authorities in obtaining PIC has also been targeted. 26 Further, there is a grave concern that access-restrictive regimes inspired by the CBD have driven companies away from bioprospecting. 27 Thus, not surprisingly, it is argued that the increasingly excessive enclosure of GR by national authorities should be fixed, favoring a more open system for GR regulation. 28 Following the CBD that confirms the authority of States in regulating GR access, 24 Jeffery, supra note 4, at 791. 25 Safrin, supra note 8, at 655-57 (assessing a failing bioprospecting project between a U.S. government initiative and the Mexican Indigenous Peoples). 26 Id. at 658-60 (arguing that a robust State GR control ignoring the consent right of local GR providers threatens the autonomy and interests of individuals and indigenous communities). 27 Id. at 668. 28 Id. at 668, & 680-85. Safrin argues that a more open system for genetic material would encourage innovation, promote conservation of such material, and facilitate collaboration between developed and developing countries. See id. at 668. 8

international efforts to ensure a better implementation of ABS continue to make progress. In addition to the CBD Bonn Guidelines 29 that provide capacity building for contracting parties, an elaboration and negotiation on the designated International Regime on ABS with possible enforcement power has been an international focal point. 30 Of course, the current draft on PIC matter is worth assessment given the possible binding nature of the document. 31 The increasing global concern over the GR access system is unable to create a satisfactory outcome without proper enforcement on a local basis. This article will therefore engage in a comparative study concerning how genetically-rich nations implement the PIC requirement with a view to examining whether the genuine objective of the CBD has been fulfilled. Following the analysis of the legal implications of PIC embodied both in international and national contexts, this article attempts to make some arguments and suggestions for an optimal normative construction of PIC, either locally or globally. After reviewing the origin of the concept and its application by international environmental rules, Part II of this article aims to disclose the legal implications of PIC under the CBD and its subsequent developments. Part III engages in a comparative study of national implementations of PIC mainly by analyzing their pertinent laws and regulations. This part will study practices of developing nations, given that most of the world s GR are located within their territories. 32 Further, in 29 Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising out of their Utilization, Report of the Sixth Meeting of the Conference of the Parties to the Convention on Biological Diversity, The Hague, April 7-19, 2002, U.N. Doc. UNEP/CBD/COP/6/20, Decision VI/24 (A), at 262 (May 27, 2002), available at http://www.cbd.int/doc/decisions/cop-06- dec-en.pdf (last visited Apr. 20, 2007) [hereinafter Bonn Guidelines]. 30 See discussion infra Part II, C. 31 See id. 32 It is however submitted that some access systems in developed countries may provide a useful reference and experience. For instance, the U.S. Yellowstone National Park has signed agreements with 9

light of an overall assessment of the global and local practices, Part IV will reveal some critical issues facing the PIC system with a view to proposing a more constructive operation of the regime in order to serve the best interests of all humankind. Finally, Part V offers a conclusion. II. The CBD and Subsequent Law-making of PIC on Genetic Resources Access A. The Origin of PIC and its Incorporation in International Environmental Rules Informed consent constitutes a cornerstone in the patient-physician relationship. In effect, physicians are obliged to disclose information to the quality of a patient s or subject s understanding and consent. 33 The patients shall be entitled to be informed of any risk and consequence of medical treatment. In addition, any medical treatment normally cannot proceed without his or her consent. The primary rational for informed consent aims at minimizing risk and avoiding unfairness and exploitation. 34 However, it is observed that the current justification for mandating informed consent has evolved to protect patients and subjects right of bioprospecters to entail the latter to engage in research related to bioresources within the Park since 19 th Century. Further, the U.S. has prescribed laws and regulations over GR access in its National Parks. See Communication from the United States, Access to Genetic Resources Regime of the United States National Parks, WTO Doc. IP/C/W/393 (Jan. 28, 2003). Australia has also developed legal systems regarding access to its rich GR, such as in the area of the Great Barrier Reef. See Sally Petherbridge, Australia: Draft Regulations on Access and Benefit Sharing, in ACCESSING BIODIVERSITY AND SHARING THE BENEFITS: LESSONS FROM IMPLEMENTING THE CONVENTION ON BIOLOGICAL DIVERSITY 201-23 (Santiago Carrizosa et al. eds., 2004), available at http://www.iucn.org/themes/law/pdfdocuments/eplp54en.pdf. 33 TOM L. BEAUCHAMP & JAMES F. CHILDRESS, PRINCIPLES OF BIOMEDICAL ETHICS 77 (5 th ed., 2001). 34 Id. 10

autonomy. 35 In the practice of medicine, informed consent proceeds via the following five-step sequence: (1) competence, (2) disclosure, (3) understanding, (4) voluntariness, and (5) consent. 36 Originating in domestic medical regulation, the idea of PIC has effectively been incorporated in international environmental rules. The PIC has already become a useful mechanism in regulating the transboundary movement of substances that may pose risks or potential harm to national or local environments. For instance, the Basel Convention requires that hazardous wastes shall not be exported without a written consent from importing State. 37 Upon the receipt of the notification of the intent to export the wastes, the State of import may respond to the request by consenting, denying the transboundary movement, or by requesting the provision of additional information. 38 Additionally, the recent effectiveness of the Cartagena Protocol on Biosafety 39 is of significance in regulating the international movement of Living Modified Organisms (LMOs). To safeguard the domestic health and environment, the Protocol employs a similar mechanism to that of the Basel convention in requiring an advance informed agreement (AIA) prior to any transboundary movement of LMOs. 40 The procedure to secure an AIA also mirrors the rules of the Basel convention. 41 Overall, in terms of the general obligation of States, the observance of PIC can 35 Id. See also ROBERT M. VEATCH, THE BASICS OF BIOETHICS 72 (2d ed., 2003). 36 BEAUCHAMP & CHILDRESS, supra note 33, at 79. 37 Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal, adopted March 22 1989, in force May 5, 1992. Art. 4 (1) (c). 38 Id. art. 6 (2). 39 Cartagena Protocol on Biosafety, adopted Jan 29, 2000, in force Sep. 11, 2003. 40 Id. art. 7. 41 Id. arts. 8-10, 12. 11

be considered as a reflection of good neighbor policy. 42 The idea of PIC modified to fit individual MEAs needs, rather than used as a unified term, has been regularly applied in MEAs as a mechanism to ensure that the autonomy of nations likely to be affected by the transboundary activities is fully respected. Of course, the implementation of PIC could also safeguard national public interest from undesirable damage as a result of unregulated transnational activities. B. The CBD and Bonn Guidelines During the era of free access to GR, generally speaking, neither national governments nor indigenous peoples or local communities were formally informed of any bio-prospecting activities occurring within their territories. As a result, the bio-searching activities had used to be operated without the approval or consent of stakeholders in questions. Of course, any bio-prospecting can make potential contributions to the revelation of GR value and lead to the generation of enormous profits. 43 Nevertheless, while lacking proper control the exploration is likely to cause damage or adverse impact on national conservation as a whole as well as upon indigenous traditions. Thus, the CBD incorporates the spirit of PIC into the GR access regime in providing that Access to genetic resources shall be subject to prior informed consent of the Contracting Party providing such resources, unless otherwise determined by that Party. 44 The CBD, as a general framework, as opposed to defining the term of PIC, seems simply to declare its intention to mandate PIC in the access process. In effect, a GR user is required to obtain PIC before accessing GR in providing nations. Relatively, GR providers are entitled to grant consent upon such applications. But the CBD itself does not articulate substantial content about the requirement. 43 Jeffery, supra note 4, at 790. 44 CBD, supra note 1, art. 15(5). 12

The absence of both a clear definition of the term and detailed configuration of the PIC system to sustain it leaves much room to be filled in. The single provision of the CBD alone cannot provide resolution for a variety of issues that may be of critical importance including, inter alia, the following 45 : 1. Who is entitled to grant the consent on GR access: national authority, private owner, and/or local community? 46 Should the PIC should be a system of single subject-given consent or it should hinge on multi-subject consent granting? 2. What are the specific rights and obligations allocated among GR providers and users? For instance, what sort of information should be submitted by GR users to obtain the consent? 3. What is the due procedure governing a PIC system? What role should PIC play in the context of access to GR? By the decision of the Conference of the Parties (COP) to the CBD at its Fifth meeting in Nairobi, Kenya in May 2000, an Ad Hoc Open-ended Working Group on Access and Benefit-sharing was created; it aims to help nations in implementing the ABS regime by developing guidelines and other approaches. 47 Engaging in 45 See also Laurel A. Firestone, You Say Yes, I Say No: Defining Community Prior Informed Consent under the Convention on Biological Diversity, 16 GEO. INT L ENVTL. L. REV. 171, 185 (2003); Jeffery, supra note 4, at 786; Columbia University, School of International and Public Affairs, Access to Genetic Resources: An Evaluation of the Development and Implementation of Recent Regulation and Access Agreements 72-74 (Environmental Policy Studies Working Paper No. 4, 1999)[hereinafter Columbia Access Paper]. 46 It has been observed that the uncertainty of who owns the consent right will create particular difficulties for bioprospectors because the GR users would not able to determine[ing] with whom they should be providing information and from whom they should be containing consent. See Jeffery, supra note 4, at 786. 47 Decision V/26 A, The Fifth Meeting of the Conference of Parties to the Convention on Biological Diversity, Nairobi, May 15-26, 2000, U.N. Doc. UNEP/CBD/COP/5/23, 196 (2000), available at http://www.cbd.int/doc/decisions/cop-05-dec-en.pdf. 13

negotiations and deliberations held in Bonn, Germany during October 2001, the Working Group finished a draft of the Bonn Guidelines. 48 At its Sixth meeting held in The Hague in April 2002, the COP adopted the Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising out of their Utilization. The Bonn Guidelines are designed to assist parties in effectively and optimally implementing the ABS mandate. 49 Despite its voluntary nature, 50 to some extent the document as a whole may help clarify vague implications embodied in the access and benefit-sharing provisions of the CBD and fill some vacancy left therein. 51 The Guidelines manage to provide a roadmap to assist relevant GR players such as GR providers, users and indigenous and local communities to locate their duties and rights within the ABS regime. 52 As a result, the major contribution of the Guidelines is to help nations in identifying the steps involved in the process of ABS and to provide them with useful guiding principles in the design and establishment of an appropriate national regime. With respect to PIC, though, in line with the CBD s context, no definition of PIC has been given by the Guidelines; however, the instrument does formulate a set of useful references upon which parties may rely to achieve better management of a PIC system. Primarily, it specifies certain basic principles of a PIC system, which include: a. Legal certainty and clarity; 48 http://www.cbd.int/programmes/socio-eco/benefit/ab-wg-01.asp (last visited June 2007). 49 Bonn Guidelines, supra note 29, para. 12. 50 Id. para.7. 51 But, irrespective of its usefulness, the Guidelines do not aim to change the rights and obligations of Contracting Parties under the Convention on Biological Diversity. See id. para. 2. 52 Id. paras. 13-16. 14

b. Access to genetic resources should be facilitated at minimum cost; c. Restrictions on access to genetic resources should be transparent, based on legal grounds, and not run counter to the objectives of the Convention; d. Consent of the relevant competent national authority(ies) in the provider country. The consent of relevant stakeholders, such as indigenous and local communities, as appropriate to the circumstances and subject to domestic law, should also be obtained. 53 The application of the principles of legal certainty, economy, and transparency in PIC will ensure any national GR access system to facilitate bio-prospecting and to avoid unnecessary barriers and restrictions to GR prospective users. 54 The principles seem to send a clear message to national governments that they should refrain from abusing or misusing the system, and are expected to run it on a fair and open basis. Moreover, with respect to which entity having the legal power to grant consent, principle (d) clearly specifies that competent national authorities (CNA) are the main entities that grant consent to applicants for a GR access. 55 However, it also considers domestic indigenous and local communities to possess an important role in the consent process; they may share the right to grant consent in accordance with domestic law. The move to support the participation of relevant stakeholders in a PIC process is of significance and suggestive of clear progress. Yet, the local consent may not be as decisive and essential as that of a CNA, given the power is to be constrained by the phase as appropriate to the circumstances and subject to domestic law. 56 In addition, some elements of a PIC system are suggested as follows: 53 Id. para. 26. 54 See also Jeffery, supra note 4, at 797. 55 See also Bonn Guidelines, supra note 29, paras.15, 28, 32. 56 Id. para. 31. 15

a. Competent authority(ies) granting or providing for evidence of prior informed consent; b. Timing and deadlines; c. Specification of use; d. Procedures for obtaining prior informed consent; e. Mechanism for consultation of relevant stakeholders; f. Process. 57 The Guidelines outline the establishment of a CNA as the critical element for running a PIC system. Despite the possible difficulty 58 of establishing such an agent in certain countries, it is observed that a well-functioning authority responsible for the matter of PIC may help in reducing transaction costs for the private sector. 59 More importantly, notorious biopiracy activities would be curtailed by the establishment of such institution. It is thus argued that the establishment of competent national authorities and the appropriate focal point to coordinate and disseminate access information may also serve to discourage biopiracy, some of which may owe its existence to frustration in obtaining relevant information as opposed to deliberate intention to avoid obtaining PIC. 60 Moreover, element (a) aims to further elaborate basic principle (d) as indicated above by reiterating that a PIC application, in principle, shall be obtained from the 57 Id. para. 27. 58 See Jeffery, supra note 4, at 798. (pointing out that the factors causing such difficulty include: the system of government in a particular country; the overlapping jurisdiction of various agencies and the interface with established legal rights of indigenous and local communities associated with the genetic resources being accessed.) 59 Id. at 799. 60 Id. 16

CNA of a Contracting Party providing resources. 61 Meanwhile, the authorities governing the system are required to respect established legal rights of indigenous and local communities associated with the GR being accessed. 62 Element (b) simply calls for PIC to be sought adequately in advance so as to be meaningful for both those seeking and those granting access. To avoid unreasonable delay, national authorities are expected to make the decision on applications for access within a reasonable period of time. 63 Element (c) suggests PIC be based on the specific uses for which consent has been granted. A new application for PIC may be required upon any change of use, including transfer to third parties. 64 In particular, the element (d) of procedure for obtaining prior informed consent, provides a number of constructive clues regarding what information should be submitted by GR access applicants. The suggested list contains the following items: a. Legal entity and affiliation of the applicant and/or collector and contact person when the applicant is an institution; b. Type and quantity of genetic resources to which access is sought; c. Starting date and duration of the activity; d. Geographical prospecting area; e. Evaluation of how the access activity may impact on conservation and sustainable use of biodiversity, to determine the relative costs and benefits of granting access; 61 Bonn Guidelines, supra note 29, para. 28. 62 Id. para. 31. 63 Id. para. 33. 64 Id. para. 34. 17

f. Accurate information regarding intended use (e.g.: taxonomy, collection, research, commercialization); g. Identification of where the research and development will take place; h. Information on how the research and development is to be carried out; i. Identification of local bodies for collaboration in research and development; j. Possible third party involvement; k. Purpose of the collection, research and expected results; l. Kinds/types of benefits that could come from obtaining access to the resource, including benefits from derivatives and products arising from the commercial and other utilization of the genetic resource; m. Indication of benefit-sharing arrangements; n. Budget; o. Treatment of confidential information. 65 The proposed list of required information should be complete and sufficient so as to facilitate reasonable, informed decision-making by national authorities. However, for researchers or companies, the disclosure of sensitive and/or confidential information poses a significant challenge, especially in the case of information relating to research and development (R & D), as suggested of sub-para. (h), etc. There is alarming concern that demand for the disclosure of information may be in contradiction with the parties right to confidentiality. 66 Thus, not surprisingly, a commentator is skeptical on the willingness of applicants to submit information critical to their business or research for seeking an access. 67 In addition, difficulties may arise as to how to precisely ascertain or evaluate the 65 Id. para. 36. 66 Columbia Access Paper, supra note 45, at iii. 67 ELLI LOUKA, INTERNATIONAL ENVIRONMENTAL LAW: FAIRNESS, EFFECTIVENESS, AND WORLD ORDER 313 (2006). 18

promising benefits of GR access while the GR exploration in question has yet to proceed. [T]he high-risk and concomitant lack of certainty involved in commercialization of genetic resources 68 may also frustrate efforts to identify real benefits relating to the resources. Sub-para. (l) simply specifies kinds/types of such benefits instead of detailed benefits; however, this allowance may reduce the burden of disclosure for GR applicants. Predictably, the justification of the proposed list will continue to be questioned. It should be noted that as indicated by the Guidelines, the disclosure of the list of information is of an optional nature- the use of which may be adapted to national special needs. 69 The Guidelines do not specify details on element (e). But, it is clear that a PIC system could not be operated in an optimal manner without the formulation of a mechanism for consultation of relevant stakeholders. 70 With respect to element (f): process, in terms of the form of applications for obtaining PIC and the decisions on the grant, the Guidelines require the process to be documented in written form. 71 GR access, as suggested, could be granted by issuing a permit or license. 72 The Bonn Guidelines aiming to aid parties in building their capacity concerning an ABS regime is not legally binding. Many obligatory implications have been 68 Jeffery, supra note 4, at 801. 69 Bonn Guidelines, supra note 29, para. 36. 70 The element of PIC echoes the Guidelines device on Participation of Stakeholders at the Part III in which it proposes that relevant stakeholders should be consulted and their views taken into consideration over ABS issues. In addition, contracting parties are advised to set up national consultative committees to include relevant stakeholder representatives. Id. paras. 18, 19. 71 Id. para. 38. 72 Id. para. 39. 19

alleviated by using the term should instead of shall. However, the Guidelines do provide countries with a useful reference upon which national capacity building may rely. 73 Thus, the influence of the document should not be underestimated. Admittedly, the Guidelines perspective on PIC may contribute to the clarification of some of the questions raised above and help parties to manage a PIC system. Overall, the Guidelines are delicately-constructed and are devoted to the creation of a balance of rights and obligations between PIC seekers, namely GR access applicants, and consent-givers, CNA and/or domestic stakeholders with a view to encouraging the disclosure of necessary information and avoiding the abuse of consent rights. On the other hand, in terms of distributing consent power over access permission among domestic entities, it is true that the Bonn Guidelines have confirmed the primary legal capacity and indispensable role 74 of national authorities in governing a PIC system. Yet, it is also an obvious attempt of the instrument to repeatedly emphasize the significant status of indigenous and local communities in a PIC mechanism, though nations still maintain the discretion to determine what sort of role they may really play. Lastly, in balancing the major power of CNA in granting PIC, the Bonn Guidelines also call for authorities to be responsible for the design and monitoring of a national ABS regime, including matters of GR access. 75 73 See Jeffery, supra note 4, at 795. 74 Id. at 798-99. 75 Para. 14 of the Bonn Guidelines provides: Competent national authorities, where they are established, may, in accordance with applicable national legislative, administrative or policy measures, be responsible for granting access and be responsible for advising on: a. The negotiating process; b. Requirements for obtaining prior informed consent and entering into mutually agreed terms; c. Monitoring and evaluation of access and benefit-sharing agreements; 20

C. The Proposed International Regime 1. An Overview of the Regime to Enforce PIC The non-binding character of the Bonn Guidelines may not satisfy the expectation that the CBD should play a more dominant role in the supervision and facilitation of the implementation of ABS on genetic resources. Accordingly, a special international institution embodied with legally-binding instruments and concerted enforcement devices was initiated shortly after the adoption of the Bonn Guidelines. The idea of creating an international regime to govern ABS matter originated in the World Summit on Sustainable Development held in Johannesburg in September 2002. Paragraph 44 (o) of the Plan of Implementation adopted by the Summit explicitly called for action to negotiate within the framework of the Convention on Biological Diversity, bearing in mind the Bonn Guidelines, an international regime to promote and safeguard the fair and equitable sharing of benefits arising out of the utilization of genetic resources. 76 In formulating the context of the international regime, the task was allocated to the Ad Hoc Open-ended Working Group on Access and Benefit-sharing with the aim d. Implementation/enforcement of access and benefit-sharing agreements; e. Processing of applications and approval of agreements; f. The conservation and sustainable use of the genetic resources accessed; g. Mechanisms for the effective participation of different stakeholders, as appropriate for the different steps in the process of access and benefit-sharing, in particular, indigenous and local communities; h. Mechanisms for the effective participation of indigenous and local communities while promoting the objective of having decisions and processes available in a language understandable to relevant indigenous and local communities. 76 Plan of Implementation of the World Summit on Sustainable Development, World Summit on Sustainable Development, Johannesburg, September 2002, available at http://www.rrcap.unep.org/wssd/documents/2002_plan_final1009.doc (last visited June, 2007). 21

of considering the process, nature, scope, elements and modalities of the regime. 77 A preliminary work prepared by the Working Group regarding the negotiation of an international regime was then submitted to the seventh COP of the CBD held in Kuala Lumpur, Malaysia on February 2004. 78 Section D of the Decision VII/19 adopted by the COP addresses the International regime on access to genetic resources and benefit-sharing. 79 The decision also requested the Working Group, with the collaboration of the Ad Hoc Open-ended Inter-Session Working Group on Article 8(j), to ensure the wide and effective participation of relevant ABS stakeholders including indigenous and local communities, NGOs, etc. 80 Further, the terms of reference underling the process, nature, scope and elements for consideration in the elaboration of the regime are included in the annex to Decision VII/19 D. 81 Concerning the nature of the regime, in contrast to the literally non-binding nature of the Bonn Guidelines, in order to effectively safeguard the ABS mandate of the CBD, the terms of reference suggest that the instruments of the regime could be of, inter alia, legally-biding character. 82 In addition to genetic resources, it also expands the scope of the regime to the protection of traditional knowledge (TK), 77 See http://www.cbd.int/programmes/socio-eco/benefit/regime.aspx (last visited Feb. 12, 2007). 78 Id. 79 Decision VII/19 D, The Seventh Meeting of the Conference of Parties to the Convention on Biological Diversity, Kuala Lumpur, Malaysia, Feb. 9-20, 2004, U.N. Doc. UNEP/CBD/COP/7/21, 298 (June 15, 2004), available at http://www.cbd.int/doc/decisions/cop-07-dec-en.pdf (last visited Feb 12, 2007)[hereinafter COP Decision VII/19 D]. 80 Id. at 300 (paras. 1, 6). 81 Id. at 301. 82 Id. 22

innovations and practices originally covered by Article 8(j) of the CBD. 83 In terms of the element of access to GR, the draft contemplates that the regime should give indigenous and local communities more vocal status. In effect, it suggests that measures to ensure compliance with the PIC of these local groups holding TK associated with GR should be considered by the Working Group as a component of the regime. 84 The content of the international regime was further refined during meetings of the Working Group based upon the decision of VII/19 D. 85 At its eighth meeting held in Curitiba, Brazil, on March 2006, the COP adopted decision VIII/4 A 86 in which a more delicate arrangement of the designated international regime had been revealed in its Annex. 87 Yet, evidently, many terms, wordings and paragraphs with or without compulsory effect remain undecided. Thus, differential or even conflicting views were 83 Id. 84 Id. at 302. 85 Two meetings were held by the Working Group in Bangkok, Thailand, from February 14-18, 2005 and in Granada, Spain, from January 30 to February 3, 2006 respectively. See http://www.cbd.int/programmes/socio-eco/benefit/regime.aspx (last visited Feb. 12, 2007). 86 Decision VIII/4A, International Regime on Access and Benefit-sharing, The Eighth Meeting of the Conference of Parties to the Convention on Biological Diversity, Curitiba, Brazil, March 20-31, 2006. U.N. Doc. UNEP/CBD/COP/8/31, 52 (June 15, 2006), available at http://www.cbd.int/doc/decisions/cop-08-dec-en.pdf (last visited Feb 12, 2007) [hereinafter COP Decision VIII/4 A]. 87 Annex to COP Decision VIII/4 A, International Regime on Access and Benefit-sharing, The Eighth Meeting of the Conference of Parties to the Convention on Biological Diversity, Curitiba, Brazil, March 20-31, 2006. U.N. Doc. UNEP/CBD/COP/8/31, 53 (June 15, 2006), available at http://www.cbd.int/doc/decisions/cop-08-dec-en.pdf (last visited Feb 12, 2007) [hereinafter Annex to COP Decision VIII/4 A]. 23

marked with brackets. The current context simply reflects divergent visions of all parties, 88 which would be subject to future continuing negotiations. 89 On the element of PIC covered by the mandate of the regime, the text reiterates the authority of GR providing parties to grant PIC. 90 More importantly, it is interesting to note that the text would tend to expand the scope of PIC to include the interaction between contracting parties that are not countries of origin of GR but which hold certain GR and contracting parties of origin. This design requires the former to restrict access to any GR in question without the PIC of the latter, which may reinforce the consent right of GR origin countries. 91 Certainly, the most novel and ambitious initiative pursued by the international regime is to establish a compliance and enforcement mechanism. Not surprisingly, with regards to PIC, the international regime would play a key role in ensuring compliance of the countries providing GR. In effect, it would be a task of the regime to prevent misappropriation 92 and unauthorized access and use of GR, which of 88 There were disagreements on many issues among developed and developing countries, including the following: the need for a new instrument and whether it should be legally binding; the inclusion of derivatives and products of genetic resources and associated traditional knowledge; disclosure requirements in applications for intellectual property rights; and, enhanced participation of indigenous and local communities in the ABS negotiations. See generally Chee Yoke Ling, CBD meeting ends with draft elements of Access and Benefit Sharing Regime (Third World Network, Feb. 3, 2006), at http://www.twnside.org.sg/title2/twninfo342.htm (last visited June, 2007). 89 The Working Group was requested to continue the formulation of the regime and to complete its work before the tenth meeting of the COPs. COP Decision VIII/4 A, supra note 86, at 52. 90 Annex to COP Decision VIII/4 A, supra note 87, at 55. 91 Id. 92 The text provides the list of activities constituting misappropriation, which includes use of GR without compliance with the provisions of the regime. Id. at 59. 24

course includes such GR access activities without PIC. However, the proposed text has yet to determine whether such an agenda is an obligation or should be imposed at the discretion of the regime. 93 In addition, with a view to establishing a notion of global responsibility to enforce ABS mandate irrespective of the country of GR origin, the current text tends to oblige all parties to ensure that the utilization of GR within their jurisdiction complies with the CBD and the conditions under which access was granted. 94 Thus, any violation of the mandate by GR users under respective jurisdiction should be sanctioned on a national basis. 95 Finally, in response to a number of patents that were granted as a result of not observing a proper access regulatory system, 96 the draft would restrict recipients of GR in applying for patents related to such resources without PIC. 97 Such a move simply reflects the general views of developing countries with rich genetic resources that strongly appeal for the inclusion of compliance with ABS elements as a condition upon which patents related to certain GR can be legally granted. 98 93 Id. at 58, 59. 94 Id. at 59. 95 Id. 96 The undesirable granted patents have been labeled as a result of Biopiracy. See generally DUTFIELD, BIOGENETIC RESOURCES, supra note 3, at 52-59; Ni, supra note 12, at 437-39. 97 Annex to COP Decision VIII/4 A, supra note 87, at 58. 98 Since the launch of the WTO Doha round negotiations, the issue of preventing bio-piracy that leads to the grant of undesirable patents based upon illicit access to GR has been formally introduced into the forum. Developing countries have been calling for the revision of the TRIPS agreement to oblige member states to mandate a disclosure of ABS elements as a prerequisite to grant patents. Their appeal, however, has met strong resistance by certain countries, especially the United States. See Communication from the United States, Article 27.3(b), Relationship Between the TRIPS Agreement 25

2. A Critique on the Regime s Preliminary Design of PIC Clearly, both the CBD and Bonn Guidelines delegate the major authority in enforcing ABS to GR providing nations. The proposal to create an international regime finds basis in the perspective that the implementation of ABS solely at a national level would be insufficient to achieve the objective of the CBD. Given the transnational nature of bio-prospecting activities, the ongoing law-making on the ABS demonstrates a resolve to enhance the international regulation of GR by establishing such a regime to coordinate and consolidate collective strength. Thus, it is no surprise to observe that the current draft of the compliance and enforcement mechanism of the regime focuses on the prevention of misappropriation and unauthorized access to and use of GR. 99 Of course, as mentioned above, the effort to build an international regime will continue until 2010, and the present proposed text may be modified accordingly. Nonetheless, its current configuration may be short of well-balanced and of a fair nature by largely serving the best interests of GR providing countries, especially countries of GR origin that support a more consolidated international mechanism on ABS. 100 The draft provisions actually put disproportionate weight and emphasis on and the CBD, and the Protection of Traditional Knowledge and Folklore, WTO Doc. IP/C/W/434 (Nov. 26, 2004); Communication from the United States, Article 27.3(b), Relationship Between the TRIPS Agreement and the CBD, and the Protection of Traditional Knowledge and Folklore, WTO Doc. IP/C/W/449 (June 10, 2005); Communication from the United States, Article 27.3(b), Relationship Between the TRIPS Agreement and the CBD, and the Protection of Traditional Knowledge and Folklore, WTO Doc. IP/C/W/469 (March 13, 2006). An appraisal of the developing countries agenda, see generally Ni, supra note 12, at 446-58. 99 Annex to COP Decision VIII/4 A, supra note 87, at 58-59. The draft tends to touch upon the issues of preventing grants of intellectual property rights (mainly patents) over an invention that derives from illegal bioprospecting or biopiracy. 100 It would not be difficult to imagine why GR rich countries, mainly developing countries, favor such an approach. Their views were disclosed in a meeting held in India in January 2005 in which Bolivia, Brazil, China, Colombia, Ecuador, India, Indonesia, Kenya, Madagascar, Malaysia, Mexico, Peru, 26