Intellectual Property, State Sovereignty, and

Intellectual Property, State Sovereignty, and Biotechnology Baruch A. Brody Kennedy Institute of Ethics Journal, Volume 20, Number 1, March 2010, pp. 51-73 (Article) Published by The Johns Hopkins University Press DOI: 10.1353/ken.0.0306

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Brody • Intellectual Property, State Sovereignty, and Biotechnology

Baruch A. Brody

Intellectual Property, State Sovereignty, and Biotechnology

ABSTRACT. The issue of biopiracy has attracted considerable attention in recent years. The Convention on Biological Diversity adopted a principle of state sovereignty over biological resources and the genetic information contained within those resources to address this issue. It is argued that this principle has not been adequately justified and that there are other solutions to the issue of biopiracy, based on different theories of justice, that deserve greater consideration. These alternatives include the common heritage of mankind principle and the global commons principle.

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n earlier essays (Brody 2006a & b; 2007), I analyze discussions about patenting biotechnology that took place in the United States and the European Union during the last 30 years. Although issues of justice arise during those discussions, they are not central. During that same period, international discussions took place in which concerns of justice were central. In this article, I analyze those discussions in connection with the biopiracy issues raised by the Convention on Biological Diversity (CBD). In a forthcoming companion article, I analyze other international discussions of justice related to intellectual property and biotechnology.1 The current essay develops both narrative and normative claims. The narrative claim is that various context-specific principles about justice relating to state sovereignty over biological and genetic resources were adopted during these discussions. These principles are independent of global principles of distributive justice and are intended to address the issue of biopiracy by extending traditional ideas about state sovereignty and seriously modifying traditional intellectualproperty right claims. The normative claim is that these extensions and modifications are inadequately justified. It might be suggested that all of the discussion about state sovereignty over these resources is really irrelevant. Descriptively, one might claim Kennedy Institute of Ethics Journal Vol. 20, No. 1, 51–73 © 2010 by The Johns Hopkins University Press

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that the adoption of the CBD was rooted simply in the desire of Southern countries to obtain a larger share of the profits derived from intellectual property rights over biotechnological discoveries, and that the opposition to the CBD reflected the desire of Northern countries—especially, the U.S.—to keep the overwhelming share of the profits. This type of economic realism is incomplete for at least two reasons: (1) it does not do justice to the tremendous amount of time and intellectual energy devoted to the discussion of the context-specific principle of justice and state sovereignty; (2) it cannot explain the willingness of Northern countries other than the U.S. to become parties to the Convention, accepting its principles about state sovereignty and genetic resources, even if doing so might go against their economic interests. One can provide a complete explanation of these developments only by the adding acceptance of context-specific principles of justice to economic realism. Normatively, it might be claimed that the only relevant issue is the global issue of the justice of the current distribution of wealth between Northern and Southern countries. This is a legitimate issue, but even if the current distribution of wealth among countries is unjust, it is an open question as to whether the adoption of an extended notion of state sovereignty over biological and genetic resources is an appropriate mechanism for correcting those injustices. Moreover, the context-specific justice claims raise legitimate additional issues of justice. So why should they be neglected? A SCHEMA AND SOME EXAMPLES

What is biopiracy and how does it raise issues of justice? To explain this, I offer a schema for biopiracy cases, explain the relevant issues of justice, and give some examples. The schema is: A corporation from a developed country sends researchers to a less developed country. They interview indigenous farmers and/or healers about plants with desirable features and purchase a few specimens of those plants from local property holders. The knowledge—especially, the genetic knowledge— gained from analyzing the acquired specimens becomes the basis for a successful program of seed (pharmaceutical product) development. The company patents the resulting product and derives considerable profits, which are not shared with the owners of the specimens, the indigenous individuals or communities, or the less developed countries. (This schema is taken from Chen (2006), with modifications.)

The issue of justice is whether the countries whose biological/genetic resources are being used are entitled to a share of the profits stemming [ 52 ]

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from their use. (I leave for the companion essay the question of the rights of the indigenous farmers/healers.) One early example, dating back to the 1950s, involves the Rosy Periwinkle, a plant that is native to Madagascar. Indigenous healers reported its usefulness in treating diabetics. Eli Lilly studied the plant and identified vinblastine (for treating leukemia) and vincristine (for treating Hodgkin’s Disease). The drugs were great therapeutic advances and commercial successes. Even if the claims of the indigenous healers to a share of the profits were weakened because Lilly discovered compounds used in fighting cancer, and not diabetes, the discoveries still stemmed from the information in one of Madagascar’s plants. Does justice require that Madagascar receive a share of the profit? A more recent example is that of Brazzein berries (United Kingdom Parliament 1999). These berries are a West African fruit with a mysterious intense sweetness. In the mid-1980s, an ethnobotanist (Claude-Marcel Hladik), working in Gabon using information provided by a Gaboneese assistant, supplied University of Wisconsin researcher Goran Hellekant with the berries and urged him to study their sweetness. Hellekant discovered a stable protein in the berries that was the source of the sweetness, isolated the protein, identified its amino acid sequence, discovered the gene encoding the protein, and identified a recombinant host cell capable of producing large quantities of the protein. He was awarded four U.S. patents that were assigned to Wisconsin’s WARF Foundation. The sweetener is not yet approved as a food additive, so it is unclear whether anyone will derive considerable profits from the work, but the case still highlights the concerns about state sovereignty: (1) Was Hladek entitled to pass on the berries without the consent of Gabon, whose sovereignty extended to the plants? (2) Is Gabon entitled to a share of any future profits, if realized? (3) How do such claims compare to those of the Wisconsin researchers who isolated the protein and identified it as the source of the sweetness, discovered the gene encoding the protein, and identified a recombinant host cell capable of large scale production of the protein? CONVENTION ON BIOLOGICAL DIVERSITY AND ITS PRINCIPLE OF JUSTICE AS RESPECTING STATE SOVEREIGNTY

The United Nations Environment Program was created in 1972 at a conference in Stockholm. Its mission is to provide leadership within the United Nations framework for environmental protection. It has placed particular emphasis on sustainable development as a crucial concept in [ 53 ]

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environmental thinking. In 1987, it adopted a U.S. sponsored resolution that a group of experts should consider whether a treaty to conserve biological diversity was needed. Such a treaty, the Convention on Biological Diversity, was presented in 1992 at a meeting in Rio de Janeiro (popularly called “the earth Summit”). The Convention came into effect in 1993, and it now has 188 parties. The United States is the only significant country that is not a party to the treaty. At Rio, the U.S. announced that it would not sign the Convention because of concerns about the protection of intellectual property rights. President Clinton reversed this decision in 1993 and sent the signed treaty to the Senate, but it was never taken up for a vote (Fletcher 1995). The Convention’s Article 1 (Biodiversity Secretariat 1993) announces three objectives: . . . 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, taking into account all rights over those resources and to technologies, and by appropriate funding.

I will focus on the third of these objectives, because it announces the intention to address the problem of biopiracy The fourth clause of the Convention’s Preamble affirms that “. . . states have sovereign rights over their own biological resources . . . .” This principle is the basis of the CBD’s response to biopiracy, which comes in Articles 15 and 16. Its response, affirming state sovereignty over biological and genetic resources and insisting upon prior agreement about the sharing of any profits resulting from the exploitation of those resources, is explicitly articulated in the text: Recognizing the sovereign rights of States over their natural resources, the authority to determine access to genetic resources rests with the national governments and is subject to national legislation. . . . Access, where granted, shall be on mutually agreed terms and subject to the provisions of this Article . . . 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 Part providing such resources. (Biodiversity Secretariat 1993, Articles 15.1, 15.4, 15.7)

There is a clear recognition that such an approach runs counter to traditional intellectual property law, and the Convention makes it clear that its principles take precedence: [ 54 ]

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The Contracting Parties, recognizing that patents and other intellectual property rights may have an influence on the implementation of this Convention, shall cooperate in this regard subject to national legislation and international law in order to ensure that such rights are supportive to and do not run counter to its objectives. (Biodiversity Secretariat 1993, Article 16.5)

In the rest of this paper, I look more closely at this principle of justice as related to state sovereignty. I begin by analyzing the meaning of the Convention’s principle by contrasting it with alternative principles. I then attempt to develop a fuller understanding of its meaning by looking at ways in which the Convention’s principles are being applied. I then explore the debate over this approach in other international settings. Finally, I offer a normative analysis of the principle’s development and justification. ALTERNATIVES TO STATE SOVEREIGNTY

There are many conceptions of state sovereignty, but the most standard is Westphalian sovereignty, a concept incorporated into the 1648 Treaty of Westphalia. Its main principle, territoriality, states that there is a defined area over which the state has the power of final authoritative decision making. Given that principle, it seems obvious that states, possessing Westphalian sovereignty over their territory, have decisional power over the use of biological resources found in their territory. The CBD affirms that, given that power, states are entitled to require those who would use their biological resources to derive genetic information—which in turn can be used to develop patented products—to agree in advance to share any resulting profits. But the CBD also affirms the validity of the concept of state sovereignty over genetic information even if the process of deriving the information and/or developing the patented products occurs outside the state’s territory. In this way, the CBD treats genetic resources as special. There might, however, be other ways of thinking of genetic resources, alternatives to the state sovereignty approach (Joyner 1986; Safrin 2004). One alternative view is the common heritage of mankind view. The concept was developed in 1967 by Ambassador Pardo to cover geographically distinct areas—e.g., outer space, Antarctica, the ocean bed—and the resources in them, but it could be extended to genetic resources wherever they are found. Christopher Joyner (1986) identifies five characteristics of such an extension: (1) There can be no state sovereignty or private ownership over genetic resources since they are part of the common heri[ 55 ]

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tage of mankind. Even if biological material is owned by individuals and falls under the sovereignty of states, genetic resources are not owned and do not fall under state sovereignty. (2) Genetic resources should be managed by some international regime. (3) Any benefits derived from these resources in terms of useful products should be shared internationally. (4) The resources should be used only for peaceful purposes. (5) The fruit of research involving these common resources should be exchanged freely and publically. In 1983, the Food and Agriculture Organization (FAO) adopted an International Undertaking on Plant Genetic Resources for Food and Agriculture that articulated a common heritage approach (at least for genetic resources relevant to food and agriculture): This Undertaking is based on the universally accepted principle that plant genetic resources are a heritage of mankind and consequently should be available without restriction. (United Nations 1983, Article 1.1)

This alternative approach, described as a “universally accepted principle,” rejects the very notion that states, as part of their rights of sovereignty, may restrict access to genetic resources. The emphasis instead is on strengthening the network of ex situ centers collecting plant genetic resources (seed banks) and holding them “. . . for the benefit of the international community and on the principle of unrestricted exchange . . .” (United Nations 1983, Article 7.1a).2 This principle of unrestricted exchange rules out any patents on these genetic resources and therefore was criticized by the American Seed Trade Association, which said that it “strikes at the heart of free enterprise and intellectual property rights” (Seabrook 2007, p. 68). The Undertaking also was criticized by developing countries that felt that it would allow the continued exploitation of their genetic resources by technologically advanced countries. Their view prevailed in 1991, with the adoption of Annex III of the International Undertaking: . . . the concept of mankind’s heritage, as applied in the International Understanding on Plant Genetic Resources, is subject to the sovereignty of the states over their plant genetic resources. (United Nations 1983, Annex III, Recognition (a))

The final transition to the state sovereignty view came after the adoption of the CBD. It was determined that the FAO would need to address definitively the crucial question of the conditions for access to the genetic [ 56 ]

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resources found in the ex situ collections, keeping in mind that they contain much—perhaps as much as one half—of the plant genetic resources in the world and that they often are located in countries other than the country of origin. This discussion continued until the adoption of International Treaty on Plant Genetic Resources for Food and Agriculture in 2001. The basic spirit of this treaty is best found in Article 10 (United Nations 2001): 10.1 In their relationships with other States, the Contracting Parties recognize the sovereign rights of States over their own plant genetic resources . . . including that the authority to determine access to those resources rests with national governments and is subject to national legislation. 10.2 In the exercise of their sovereign rights, the Contracting Parties agree to establish a multilateral system, which is efficient, effective, and transparent, both to facilitate access . . . and to share, in a fair and equitable way, the benefits arising from the utilization of these resources on a complimentary and mutually reinforcing basis.

The treaty is designed to reaffirm state sovereignty while promoting facilitated access through the creation of a multilateral system that promotes equitable sharing of the benefits arising from the use of genetic resources.3 On that point, it continues to embody some components of the common heritage of mankind approach. The other alternative approach is the global commons view, which considers genetic resources to be no different from any other resource. It disagrees with the common heritage of mankind view in that it allows researchers who use the genetic information to develop useful products to patent those products. But it also disagrees with the state sovereignty view in that it allows researchers to use biological material found outside the state’s territory—e.g., in seed banks—to do studies to derive genetic information and develop patentable products without being under any obligation to share the resulting profits with the state of origin of the biological material. Naturally, states, as part of their Westphalian sovereignty, can regulate the gathering of biological resources within their territory and can demand that the state receives a share of the profits from any resulting patented products. But Westphalian sovereignty does not extend beyond that, even in the case of genetic resources. This alternative approach has been advocated by many developed countries in discussions about this issue at the World Trade Organization (WTO), and I return to this view later in my discussion. [ 57 ]

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IMPLEMENTATION OF THE STATE SOVEREIGNTY VIEW

In the last 15 years, much has been done to implement the state sovereignty view, both within the institutional framework created by the CBD and outside of it. Here I present some representative examples to further explicate the state sovereignty view. The most important internal development within the CBD was the adoption in 2002 of the Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits. These guidelines, addressed to the member parties, are meant to address issues of access and of equity, and one crucial clause covers each of those issues. In short, justice in the Bonn Guidelines is procedural justice based on prior informed consent and mutually agreed terms. Guideline 24 makes clear that the crucial requirement for access to genetic resources is prior informed consent “. . . of the contracting Party providing such resources, unless otherwise determined by that Party” (Biodiversity Secretariat 2002). The consent to be obtained is first and foremost the consent of the sovereign states. But the prior consent of other parties might also be required: Respecting established legal rights of indigenous and local communities associated with the genetic resources being accessed or where traditional knowledge associated with these genetic resources is being accessed, the prior informed consent of indigenous and local communities and the approval and involvement of the holders of traditional knowledge, innovations and practices should be obtained, in accordance with their traditional practices, national access policies and subject to domestic laws. (Biodiversity Secretariat 2002, Guideline 31)

This emphasis on prior consent, of the sovereign states and of others, is carried over to the question of the equitable sharing of benefits in Guideline 48: Pursuant to mutually agreed terms established following prior informed consent, benefits should be shared fairly and equitably with all those who have been identified as having contributed to the resource management, scientific and/or commercial process. The latter may include governmental, non-governmental or academic institutions and indigenous and local communities. (Biodiversity Secretariat 2002)

A recent development is the 2006 adoption of a decision (VIII/4) to support the development of an international regime to focus on the facilitation and enforcement of the mutually agreed upon terms (Biodiversity [ 58 ]

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Secretariat 2006). The decision calls for the presentation of a definite plan at the 2010 Conference of Parties. The 2008 Conference of Parties adopted a whole series of proposals designed . . . to finalize the international regime and to submit for consideration and adoption by the Conference of Parties at its tenth meeting an instrument/instruments to effectively implement the provisions in Article 15 and Article 8 (j) of the Convention and its three objectives . . . . (Biodiversity Secretariat 2008, #3)

It has been suggested (GRAIN 1998) that the CBD is hostile to intellectual property rights held by the developers of new products based upon genetic resources, but this is a bad mistake. The CBD and the Bonn Guidelines support just intellectual property rights, where justice is defined procedurally in terms of prior mutually agreed upon terms. In fact, the Conference of Parties, in its 2002 adoption of the Bonn Guidelines, called upon the World Intellectual Property Organization (WIPO) to develop model intellectual property clauses “which may be considered for inclusion in contractual agreements when mutually agreed terms are under negotiation” (Biodiversity Secretariat 2002, Appendix II, C (9)). The opposition is only to intellectual property rights that do not involve a just sharing of benefits with the sovereign states whose genetic resources have been used. This is exactly what one would expect in a state sovereignty approach. I turn now to three representative developments of the state sovereignty approach occurring outside of the institutional framework created by the CBD: the Merck- INBio Agreement, the Andean Community’s common regime on access to genetic resources, and the African model legislation on the regulation of access to biological materials. The first development is an agreement signed in 1991 between Merck Pharmaceuticals and INBio, a Costa Rican nongovernmental organization (with close official relations). It has served as a model for the prior consent approach to equitable benefit sharing adopted in the CBD and in the Bonn Guidelines (Bowen 2005; Columbia University 1999). INBio collected and inventoried biological samples and prepared them for chemical analysis by Merck. Merck had the exclusive right to receive a specified number of these samples. INBio received $1,000,000 up front from Merck, as well as $135,000 in equipment to use in the preparation process. Merck retained the intellectual property rights to any commercial products developed in this process, but there were royalty sharing provisions. Although Merck has secured patents from this process, no royalties have been earned. Two points about this agreement attracted attention: [ 59 ]

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(1) benefit sharing primarily may be a matter of helping to build research infrastructure, even when there are provisions for royalty sharing; and (2) Merck wound up having intellectual property rights, so, as noted above, state sovereignty and prior consent allow for these rights as long as there are provisions for benefit sharing. The second development is the1996 adoption by the members of the Andean Community of Decision 391 on a “Common Regime on Access to Genetic Resources” (SICE 1996). This is the first regional attempt to carry out the prior consent and benefit sharing model. It contains a number of provisions that help define this approach. It recognizes that there are other parties besides the sovereign state that have legitimate claims over genetic resources. The legitimate claimants are: (1) the state; (2) the possessor of knowledge about the properties of the resource; (3) the owners of the property on which the biological resource is found; and (4) the developers of the products that produce the profit. The division of those profits is determined by prior agreement among these parties. Article 41 therefore calls for ancillary contracts—beyond that between the state and the developer—with these other entities. The decision also attempts to develop mechanisms for enforcing the rights of the sovereign state, even over patented products developed outside the state, from biological resources ex situ. Internal violators can, of course, be punished for violations by criminal or civil sanctions. But what can be done about companies from other countries that export the biological resource without any access contract and use it to develop commercial products in whose profits the state does not share? The document contains a number of Complementary Provisions of which the second is particularly relevant: The Member Countries shall not acknowledge rights, including intellectual property rights, over genetic resources, by-products or synthesized products and associated intangible components, that were obtained or developed through an access activity that does not comply with the provisions of this Decision. Furthermore, the Member Country affected may request nullification and bring such actions as are appropriate in countries that have conferred rights or granted protective title documents. (SICE 1996, Complementary Provisions, Second)

The last clause is the more important, but it is not clear whether such actions will be successful or even whether they are justified. I return to these issues later in the discussion. [ 60 ]

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The third example is the 1998 adoption by the Organization of African Unity (now the African Union) of Model Legislation for the Protection of the Rights of Local Communities, Farmers and Breeders, and for the Regulation of Access to Biological Resources (OAU 1998). Its provisions on state sovereignty over biological resources, collective rights of local communities, and access to biological resources through prior informed consent and equitable sharing of benefits are standard. But it contains a number of provisions that deserve special notice It explicitly rejects patents on life forms, with a quite original argument: Whereas, all forms of life are the basis for human survival, and, therefore, the patenting of life, or the exclusive appropriation of any life form or part or derivative thereof violates the fundamental human right to life. (OUA 1998, last of the preambles)

Still, the document recognizes that earnings from the biological resources may be realized and it provides: The State shall ensure that at least fifty percent of benefits provided for in Article 12.2 shall be channeled to the concerned local community or communities in a manner which treats men and women equitably. (OAU 1998, Part IV, 22)

What are the lessons learned from this survey of the implementation of the state sovereignty view? The following points stand out: • T  he acceptance of the state sovereignty view is perfectly compatible with the recognition that others have rights related to inventions arising from the genetic information found in the biological resources. The Andean Community’s presentation is particularly strong on this point, recognizing that there are four claimants to the benefits from a useful invention developed from genetic information found in local biological resources—the state, local communities, owners of the biological resource, and the developer of the invention. This is true even though the state has sovereignty over the biological resource and the genetic information. • The Bonn Guidelines develop the idea that the way to accommodate the legitimate claims of these various parties is by consent of all parties to a benefit sharing agreement prior to the potential inventor accessing the biological resource and the genetic information within it. The OAU emphasizes that this consent, especially in the local communities, must involve the women in those communities as well as the men. The crucial point is that justice in the sharing of benefits from access stems from prior agreements.

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• T  he benefits that are to be shared come in many forms. Up-front payments and infrastructure building activities are two forms of benefit found in the Merck Agreement. Equally important, as stressed in the Bonn Guidelines and the work of the World Intellectual Property Organization, is the sharing of the benefits from any resulting intellectual property rights. Even if the invention cannot be patented because of restrictions on patenting, such as a restriction on patenting life forms, there are still analogous benefits to be shared. So this approach is not antithetical to a system of just intellectual property rights that recognizes the legitimate claims of the various involved parties. THE DEBATE IN OTHER SETTINGS

The other major forum in which these issues have been discussed is the World Trade Organization (WTO), which adopted the Agreement on the Trade-Related Aspects of Intellectual Property Rights (TRIPS) in 1994. TRIPS sets down the minimum standards that all countries must meet in their laws governing intellectual property (WTO 1994). Article 27 of the TRIPS agreement requires that member countries make available patents on all inventions, unless the patent challenges “ordre public” or morality, covers a method for the treatment of humans or animals, or covers “plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes” (WTO 1994, Article 27.3(b)). Many countries objected to this provision because it seems to allow for receiving countries to obtain patents on products developed using genetic information derived from biological resources gathered from source countries, in violation of the CBD. This issue was so controversial that the TRIPS agreement called for it to be reexamined within four years, but it was not addressed until 2001, when a ministerial declaration called on the TRIPS Council to examine the relation between TRIPS and the CBD (WTO 2001, Clause 19). What is the potential conflict? GRAIN, a nongovernmental organization (NGO), put forward a much quoted analysis about the conflict between TRIPS and the CBD, relating it to the meaning of state sovereignty. The fundamental conflict between CBD and TRIPS is simple and irreducible: CBD recognizes that states have national sovereignty over their biological resources. TRIPS tries to introduce private individual rights over the same. Within one country the states’ sovereignty takes precedence, and the CBD

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framework may prevail. But between a foreign IPR holder and a sovereign state, the state’s jurisdiction is limited and cannot countervail the IPR holder. (GRAIN 1998, Section 4.3)

The practical implications of this point are developed more fully in a statement from the Third World Network, another NGO: In TRIPS, there is no provision that applicants for patents or other IPRs over biological resources have to obtain prior informed consent. There is thus no recognition in TRIPS of the rights of the country in which the biological resource or knowledge of its use is located. Thus, patent applicants can submit claims on biological resources or knowledge to patent offices in any country (that recognizes such patentability) and the patent offices can approve the claims without going through a process even of checking with the authorities of the country or countries of origin. (TWN 2001)

This way of thinking has led to an approach that would require patent applicants filing an application in any country in the world to disclose the country of origin of any biological resources or traditional knowledge used in making the invention and to document prior consent from, and an agreement on benefit sharing with, a competent national authority from that country (Curci 2005). In this way, national sovereignty would be extended to cover actions taking place in other countries. One cannot validly patent an invention in a receiving country without the prior consent of the country of origin, which has sovereignty rights over the biological resource and the genetic information contained within it. Typical of this approach is the following proposal championed by India and Brazil in the debates at the WTO: 2. Where the subject matter of a patent application concerns, is derived from or developed with biological resources and/or associated traditional knowledge, Members shall require applicants to disclose the country providing the resources and/or associated traditional knowledge, from whom in the providing country they were obtained, and, as known after reasonable inquiry, the country of origin. Members shall also require that applicants provide information including evidence of compliance with the applicable legal requirements in the providing country for prior informed consent for access and fair and equitable benefit-sharing arising from the commercial or other utilization of such resources and/or associated traditional knowledge . . . . 4. . . . Members shall ensure that administrative and/or judicial authorities have the authority to prevent the further processing of an application or the grant of a patent and to revoke, subject to the provisions of Article 32 of this Agreement, or render unenforceable a patent when the applicant

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has, knowingly or with reasonable grounds to know, failed to comply with the obligations in paragraphs 2 and 3 of this Article or provided false or fraudulent information. (WTO 2006a)

There is, of course, another side to this issue. One of the NGOs that have articulated it is the International Chamber of Commerce. Secondly, the national sovereignty recognized by the CBD is not a new principle. It is a re-affirmation of a recognized principle: that a sovereign nation has control over whatever goes on within its borders. It can control exports and imports, and set conditions for them, and it is by virtue of this power of control that it is enabled to set conditions for access to biological resources within its borders. By joining the CBD, nations undertake to adhere to the principles the CBD embodies in controlling such access. What the CBD does not do is create a new right of property in genetic materials, let alone one that nullifies other possible rights . . . . (ICC 1999)

This more traditional approach also has been adopted by many countries, most notably the United States. Consider, for example, the following passage from a 2004 submission by the United States to the World Trade Organization: Effective enforcement regimes for access and benefit-sharing should be part of civil and criminal codes specifically designed to enforce access and benefitsharing laws . . . . As is done in the case of these other distinct regulatory systems, criminal provisions and/or civil liability for failure to comply can be included in the country’s laws for those few who might take genetic resources without entering into an access agreement with the required party. (WTO 2004, Sections 35–66)

Of course, such criminal and civil provisions govern behavior taking place in the country of origin—“those few who might take genetic resources without entering into an access agreement . . .”—and are enforced primarily by and in the country of origin. The United States is suggesting that traditional concepts of state sovereignty should be sufficient to deal with these issues, and that no concept of state sovereignty that extends it to cover patenting activities in other countries is needed or justified.4 The United States is arguing for a modified global commons position. It concedes, in support of the CBD and against the common heritage of humanity position, that states have sovereign rights over biological material found in their territory and can control access to that biological material by those who would seek to use the genetic information found in it. Such

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control can include imposing requirements of prior informed consent and benefit sharing agreements. But none of this justifies a state’s control over the use in another country of genetic information to develop new products that can be patented. This is its disagreement with the CBD. It is, of course, the possibility of patenting new products that distinguishes this position from a common heritage of humanity position.5 With the 2008 collapse of the “Doha round” of negotiations at the World Trade Organization, this debate was not resolved. As things stand, the WTO has not settled on any official view about state sovereignty over genetic information.6 NORMATIVE ANALYSIS OF THESE DEVELOPMENTS

What is the lesson derived from this description of the international debate about state sovereignty over biological resources and the genetic information contained within them? In the early 1980s, there was considerable support for the view that genetic resources are part of the common heritage of mankind. This was explicitly stated in the 1983 International Undertaking (United Nations 1983). But countries that were rich in genetic resources opposed this view, which led to the adoption in the early 1990s of the concept of state sovereignty over genetic resources reflected in the CBD and later in the International Treaty (United Nations 2001). On this account, biological and genetic resources may be accessed only after the state of origin has given its consent based upon an agreement to share any resulting benefits. Those opposed to this view argued for a global commons view of genetic resources in deliberations at the World Trade Organization, which failed to reach a conclusion on these issues by the end of those deliberations in 2008. This generates two crucial normative questions: (1) What is the justification for the principle of state sovereignty over genetic resources? (2) If it is justified, are mutually agreed terms a satisfactory way of justly dividing the gains from the development of biotechnological products from genetic resources? The traditional doctrine of state sovereignty is a doctrine of state authoritative decision making about a territory, about the material objects found in that territory, and about the actions of persons located in that territory. It certainly entails that the state can make authoritative decisions about internal access to, or internal use of, the biological material found within its territory. But how far should this authority extend? (1) Should it apply to the internal abstraction and use of the genetic informa[ 65 ]

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tion found in the biological material as well as to the biological material itself? (2) Should it apply to the external use of the biological material previously taken from the country? Should it, for example, extend to the case in which the biological sample had been taken from the country of origin, in a manner that was perfectly legal7 at the time of the taking, for deposit in some international repository of plants or animals, and was then used to develop a commercial product? This is, of course, the very issue raised by Article 15 of the International Treaty discussed previously (United Nations 2001). (3) Should the state’s authority apply even further to the external use of genetic information abstracted from the biological material? Should it cover the case in which foreign researchers in their home countries use published information about the genome of a species for the development of a biotechnological product? Does the country of origin have sovereign rights over that extraterritorial use of the information? In all three cases, the CBD affirms state sovereignty over the genetic resources. Is that justified? Application (1) seems justified. It concerns actions performed within the country in question, and state sovereignty has always covered such internal actions. The burden of proof is on those who would exempt such actions because they involve genetic information, which is considered special—because it is a global commons or because it is part of the common heritage of humanity. But applications (2) and (3) are very different. In (2), the actions are performed outside of the country on biological material currently residing outside the country of origin. The burden of proof now shifts to those who would support the extension of state sovereignty to such cases. The opposition could argue simply that no basis has been provided for the exercise of sovereignty by the country of origin. This is even truer in application (3). Moreover, the situations in (2) and (3) actually violate the sovereignty of the country in which the uses take place. The country of origin of the biological material would be given authoritative decision making over the uses of that material and the genetic information contained within it in the country in which the use takes place. Many who supported these applications did not realize that they are extensions of the state sovereignty model that require justification. They saw the developments simply as straightforward implications of the traditional principles of state sovereignty: It is thus apparent that the notion of common heritage is the opposite of principles of international law governing access to or control over assets or properties, particularly natural resources, that fall within the jurisdiction

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of a recognized state . . . . This is a well known principle of international law, and it need not detain us here. (Mgbeoji 2006, p. 98)

Those who advocate the global commons conception of genetic resources should not be moved by this way of thinking. International law certainly implies that biological material, as material assets, are covered by the concept of state sovereignty when located within the state. But it does not necessarily apply to the same material once it has been exported. Nor does the law necessarily speak to the abstract genetic information contained within the samples. So the CBD’s use of state sovereignty requires further justification. So far, my analysis has criticized the adoption of the state sovereignty view of genetic resources by arguing that such an extension of state sovereignty beyond its traditional meaning has not been justified. This is the type of criticism that would be offered by defenders of the global commons view, who would confine the doctrine of state sovereignty to state authority over actions pertaining to genetic material that occur within its own territory. But defenders of the common heritage of mankind view might go further and argue that any view of state sovereignty over genetic resources, restricted or extended, is a mistake. After all, any doctrine of state sovereignty over genetic resources seems to be in conflict with an emerging recognition that state sovereignty over natural resources may pose serious problems in light of the world’s global ecological interdependence.8 States may manage their resources in ways that directly benefit them—at least in the short term—without adequate concern for the global implications of their decisions. Applying this way of thinking to genetic resources suggests that a common heritage of mankind approach might better serve global interests. I turn now to the definition of justice by reference to mutually agreed upon terms. The Bonn Guidelines and many of the other documents I have discussed show a robust commitment to mutually agreed upon terms. It is not hard to see why. If both parties have agreed to the terms, does that not mean that the terms are just? Perhaps not. Perhaps the researcher has far greater bargaining power and is capable of demanding and getting agreement to terms that are exploitative? If the developing country is really desperate for the benefits from entering into an agreement, that desperation can be exploited to get the country to agree to receive an unjust share of the benefits. Alternatively, the developer of new biotechnological products may have strong reasons for wishing to have access to particular biological samples. But under the system of mutually agreed upon terms, [ 67 ]

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the country having sovereign rights over those biological samples is entitled to demand extensive benefits for allowing access to its biological samples. If it has a monopoly over those biological resources, it can extract monopolistic rents from the developer. Would this be equitable? Both of these possibilities suggest that faith in mutually agreed upon terms may not be justified. Underlying these objections is the idea that there can be voluntarily agreed upon terms that are mutually beneficial but inequitable because the party with the greater bargaining power is able to demand too great a share of the benefits. This idea of noncoercive mutually beneficial exploitation has been developed extensively in the philosophical literature, most notably by Alan Wertheimer (1996). Such an approach does presuppose a concept of equitable terms defined independently of mutually agreed upon terms, and that is not an easy concept to develop. But it is strange that the Bonn Guidelines and other documents do not even consider such objections. Perhaps their authors put too much trust in mutually agreed upon terms as a response to concerns about exploitation, and this should be a concern as the CBD creates its international regime. CONCLUSION

The Convention on Biological Diversity accepted a revised version of the idea of state sovereignty, one that extended the state’s authority over the use of its genetic resources even when that use occurred outside of the state’s territory. This means that it treats genetic resources as special. In doing so, it rejected an alternative view—the common heritage of mankind—supported for a time in the FAO, which also treated genetic resources as special, but did so by claiming that states had no sovereignty over genetic resources. The CBD also rejected a the global commons view, which claims that genetic resources should be treated no differently than any other resource. The global commons view has been advocated at the World Trade Organization by many countries, including some that are members of the CBD. I have not attempted to resolve this debate. What I have argued is that the state sovereignty view should not be taken for granted as an obvious extension of traditional views about state sovereignty. It requires further justification against both alternatives. There is another way of stating this conclusion. The CBD understands the problem of biopiracy as outsiders benefitting from the use of genetic resources without sharing the benefits with the country of origin, and it solves that problem by a requirement that benefit sharing agreements be [ 68 ]

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reached prior to access. That solution is open to challenge because it still allows exploitation based upon unequal bargaining power. Alternatively, the common heritage view understands the problem of biopiracy as involving states’ claim of sovereignty and individuals’ claim of ownership over genetic resources, and it would solve the problem by denying both of these claims. Finally, the global commons view understands the problem of biopiracy as people taking biological material from a country without securing the approval of that country. It solves the problem by requiring benefit sharing agreements before taking the biological material, with perhaps an additional requirement that material taken illegally may not be used elsewhere. All three of these perspectives have some initial appeal, and further analysis is required to determine which view offers the best way of conceptualizing and addressing the problem of biopiracy. NOTES

1. I have chosen to begin with the issues related to the Convention on Biological Diversity because they seem to have attracted much less attention in the writings of American bioethicists. Thus, in Johnston and Wasunna’s (2007) comprehensive discussion of patents, there is much about the TRIPS-related issues but almost nothing about the CBD issues. 2. There is a subtle, but important, difference between my account here and that offered by Mgbeoji (2006), who is keen to insist that the concept of the common heritage of mankind was never adopted in any international agreement, stressing the 2001 International Treaty on Plant Genetic Resources for Food and Agriculture (United Nations 2001) and disregarding the text of the 1983 International Understanding. See also the portrait of the seed banker, Cary Fowler, in (Seabrook 2007), for further discussion of these issues in the context of Fowler’s work. 3. Histories of these developments are found in Coupe and Lewins (2007) and Rose (2004). It is crucial to note that Article 15, on ex situ collections, started the process whereby the use of any biological material in those collections generates an obligation to share the resulting profits with the multilateral system, even if the material was deposited at a time in which no prior agreements about benefit sharing existed. It also provides that future deposits of biological material should be based upon a benefit sharing agreement with the providing country. 4. A defense of this U.S. opposition, stressing the point that the claims of state sovereignty and rights of indigenous parties fail to do justice to the contribution of those who develop the new technology—contributions that should be

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5.

6.

7.

8.

rewarded both on Lockean and utilitarian grounds—can be found in Burk, Barovsky, and Monroy (1993). It is important to note that although the United States is not a member of the CBD, other countries that supported the global commons view at the WTO are members of the CBD, which had rejected the global commons view (WTO 2006b). Consistency is apparently not a requirement in international diplomacy. A particular round of WTO negotiations ends with an agreement covering all of the issues on the table. If agreement cannot be reached on all of the major issues, then the entire round collapses. This way of doing business is essential for unanimous agreement. So long as any country can get what it wants on some issues, it has reasons to agree with what other countries want on other issues. Does the legality of the exporting of the sample make a difference? The exporter’s illegal activities may be covered by the country of origin’s state sovereignty, but does the state’s authority extend to the subsequent extraterritorial use of that biological sample by others? A recent amendment to the Lacey Act (53 USC 16 §3372) prohibits the possession within the United States of any plant “taken, possessed, transported, or sold without the payment of appropriate royalties, taxes, or stumpage fees required for the plant by any law or regulation of any State or any foreign law” (emphasis added). This seems to prohibit biotech companies in the United States from developing products using genetic information from biological samples imported into the U.S. without following the laws of the country of origin. I thank my colleague Mary Majumder who called my attention to a discussion of these matters in Khatchadourian (2008). Litfin (1997) provides an excellent an analysis of these issues. One should also note that this emphasis on state sovereignty seems to conflict with the growing impact of cosmopolitan thinking in this area (Pogge 1992). REFERENCES

Biodiversity Secretariat. 1993. Convention on Biodiversity. Available at http:// www.biodiv.org/convention/convention.shtml, accessed 19 February 2010. ———. 2002. COP 6 Decision COP VI/24: Access and Benefit-Sharing as Related to Genetic Resources (Bonn Guidelines). Available at http://www.cbd.int/ decision/cop/?id=7198, accessed 19 February 2010. ———. 2006. COP 8 Decision VIII/4: Access and Benefit-Sharing. Available at http://www.cbd.int/decision/cop/?id=11016, accessed 19 February 2010.

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