Document(s) 9 of 20

Biodiversity encompasses the whole of life on this planet. Today's biodiversity has developed from over four billion years of evolution. Yet the actions and development of one species, ours, is now the biggest threat to the immense biodiversity on the planet – something of irreplaceable value in itself as well as vital for our wellbeing, whether for our food, health or climate. Moves to safeguard all aspects of biodiversity do not take place in a vacuum nor are they uninfluenced by social and economic developments. Indeed, as this and the next chapter show, and earlier chapters have indicated, the expansion of intellectual property (IP) into the biological sphere and the reactions to that have overshadowed at times and helped shape the types of international agreements affecting IP and biodiversity. This chapter gives a background to the negotiation of the Convention on Biological Diversity and its Cartagena Protocol on Biosafety, their key aims, and issues arising in their implementation.

Introduction and background

A growing appreciation of the monetary and non-monetary value of genetic resources – catalysed by enormous strides in molecular biology and genetic engineering – provided the backdrop to the negotiations of the Convention on Biological Diversity (CBD, signed May 1992, entered into force 1993). An understanding of the dynamics behind increasing conflict over rights and responsibilities for these resources is necessary before discussing the CBD itself. It is also relevant to the discussion of the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA or the Treaty) in Chapter 6.

The current international debate on legal regimes for genetic resources has its origins in the late 1970s and early 1980s, when developing countries became concerned by moves in industrialized countries to extend IP protection to living organisms. New legislation, court rulings and international agreements such as UPOV (see Chapter 2) had made it possible to obtain plant breeders' rights and patent protection over living organisms in the US and many European countries. Prior to this time, economic and political interest had rested at the species level, as the species was the relevant unit at which economic value could be recognized. The ability to gain IP protection over genetic resources gave them economic value and resulted in increased political interest at both the national and international levels. Initially, however, this expanding scope of IP protection only addressed one side of the value chain – biotechnology and plant breeding – without addressing the other side – conservation and traditional development (Bragdon et al, 2005; Bragdon, 2004).

While IP protection expanded in scope most quickly in developed countries, the majority of biodiversity is located in developing countries, although it is not evenly distributed. Traditionally, genetic resources have been considered common resources or common heritage and were freely moved around the world (Brockway, 1979; Crosby, 1986). Politically, this was not a problem while the sources of germplasm were under colonial rule or while genetic resources appeared to belong to no one. But with the dismantling of the colonial system after World War II and the expansion of intellectual property law in Northern countries, genetic resources – and plant genetic resources in particular – became 'politically salient' (Stenson and Gray, 1999, p15).

The concern of developing countries focused on the free flow of genetic resources along a predominantly developing country to industrialized country pathway, with no flow of benefits back to developing countries when research on those resources led to commercial products protected by patents or plant breeders' rights. The focus was on genetic resources collected for pharmaceutical research, since when this research resulted in a commercialized product it tended to generate much more value for the developer than would genetic resources used in agricultural research. Furthermore, collections of plant genetic resources for food and agriculture had also been of great benefit to developing countries (Bragdon, 2004, pp58–59; see also Chapter 6). Nonetheless, developing countries felt that their contributions to the conservation and development of these genetic resources were not being recognized.

When developing countries debated the ownership and control of plant genetic resources at the UN Food and Agriculture Organization (FAO) (Chapter 6), the debate was highly politicized, with concerns about intellectual property rights (IPRs) and national germplasm embargoes (Mooney, 1983). At the FAO Conference in 1983, developing countries succeeded in forcing through a resolution creating the International Undertaking on Plant Genetic Resources (IU – see Chapter 6). The IU declared plant genetic resources to be the common heritage of mankind, meaning they should be free and open to everybody. It made it clear that this open availability was to apply to all plant genetic resources, including 'special genetic stocks', which was interpreted to include the proprietary lines of breeders (Article 2). Furthermore, in the resolution by which the IU was adopted, Member States recognized that 'plant genetic resources are a heritage of mankind to be preserved, and to be freely available for use, for the benefit of present and future generations'. The aim, then, was to ensure that it was not just genetic resources from the South that could be freely accessed but that all plant genetic resources were subject to free access. The acrimonious debate on access to and the ownership and control of plant genetic resources during the adoption of the IU and its further refinement was dubbed the 'seed wars' by the Wall Street Journal (Kloppenburg and Kleinman, 1988).

While the IU was not a legally binding instrument, it represented an effort by developing countries to prevent access to plant genetic resources from being restricted by different forms of IP protection. Because of its rejection of IPRs, eight developed countries¹ refused to adhere to the IU, perceiving it to be contrary to their economic interests. The rejection of the IU by these countries meant that the free flow of genetic resources from South to North continued largely unabated, and developing countries continued to feel that access to products for research based on genetic resources would remain encumbered. Another approach was needed.

In an effort to resolve the conflict between the IU and IPRs on genetic resources, three interpretations of the IU were made during the late 1980s and early 1990s. The revisions included calling for farmers' rights, an acknowledgment of plant breeders' rights and a statement that nations have sovereign rights over their plant genetic resources.

CBD origins

The CBD's origins fall roughly into categories corresponding to what became its three objectives. One major source was conservationist concerns that existing international law for the protection of wildlife was a patchwork that covered only selected issues, areas and species (Bragdon, 2004, p15). While the idea of negotiating an umbrella convention that would harmonize existing international conservation treaties was quickly dropped due to the 'numerous practical, political and legal obstacles' it posed (McGraw, 2002, p12), proponents of a conservation rationale did succeed in creating an agreement that embraces an ecosystem approach to conservation (see also Chapters 6 and 8). The ecosystem approach embodies a broader concept of nature and its value, including the full diversity of life at the level of genes, species and ecosystems. For this reason, it should result in the protection of many elements of biodiversity not covered by preexisting international or national laws. The US, an initial supporter and instigator of the call for an international treaty, was motivated primarily by such conservation concerns (McGraw, 2002, p11; McConnell, 1996, p5; Bragdon, 1992).

Conservation of biological diversity may have provided the impetus for the initiation of negotiations, but the purpose and scope of the Convention changed as discussions got underway. Notably, developing countries were able to secure concessions that they had been unable to secure in other fora (McGraw, 2002, p7). This included consideration of the economic aspects of conservation, which take two broad forms in the Convention: sustainable use and access issues.

The second origin of the CBD, therefore, was a move to incorporate the goal of sustainable use of biological resources into conservation policy, recognizing the need of local people living amid biodiversity for sustainable development, and hence the need to mobilize support for conservation by providing local benefits. Distinguishing sustainable use from conservation emphasizes the desire of developing countries to use their biodiversity in their economic development (Glowka et al, 1994, pp1 and 4; Bragdon, 2004, p15; Bragdon, 1996).

Finally, many developing countries insisted that the negotiations on the Convention include:

… obligations and measures on three types of access: access to genetic resources, which they wished to have recognized as subject to national authority; access to relevant technology, stressing that it includes biotechnology; and access for the providing States to benefits ultimately gained from the use of genetic material in the development of biotechnology. (Glowka et al, 1994, p5).

These access issues resulted in some of the most contentious aspects of the negotiations. They also resulted in significant shifts in international law (Bragdon, 1992). As will be discussed in more detail below, Article 3 of the

Convention provides that states have sovereignty over their resources. When read in conjunction with Article 15(1), this includes state sovereignty over genetic resources. Furthermore, Article 15(3) requires Parties to 'facilitate access to genetic resources for environmentally sound uses', another change in international law. After failing with the common heritage approach in the IU, developing countries changed tactics, seeking and obtaining the right to control access to genetic resources.

In contrast to the IU negotiations that took place under the FAO, and that were normally led by ministries of agriculture, negotiations for an international convention on biological diversity were conducted under the aegis of the United Nations Environment Programme (UNEP), beginning in May 1989 and were generally led by ministries of the environment. An ad hoc Group of Legal and Technical Experts and an Intergovernmental Negotiating Committee together met seven times to conduct the negotiations that resulted in the CBD. Controversial issues during the negotiations included biotechnology, IPRs and financing (McConnell, 1996). The negotiations ran through the United Nations Conference on Environment and Development (commonly known as the Earth Summit) in Rio de Janeiro in June 1992, but in the end the Convention was concluded on time and an astonishing 156 countries signed the CBD during the Earth Summit (McConnell, 1996, p111). The Convention entered into force 18 months later, having received the necessary 30 ratifications, and, as of mid-2007, the CBD has achieved near-universal ratification, with 190 Parties.

A notable non-Party to the Convention is the US. Despite having been an initial proponent of the negotiations, the US was indicating its displeasure with the direction of the negotiations prior to the final text being concluded. Early opposition focused on the inclusion of biotechnology within the scope of the Convention, a move which the US opposed with increasing vehemence (McConnell, 1996). Subsequent opposition included concerns about the provisions on IPRs. Initially, the US declined to sign the CBD, citing concerns with Article 16 and its provisions on IPRs in particular, but in 1993 President Clinton did sign the Convention and sent it to the Senate for ratification, where it is still pending in the Senate Committee on Foreign Relations. The US does attend CBD meetings as a non-Party and is able to exert its influence on CBD processes through other CBD Parties and discussions taking place in other fora such as the WTO.

The Convention

The scope of the CBD includes all aspects of biological diversity, which it defines as meaning the 'variability among living organisms from all sources including, inter alia, terrestrial, marine and other aquatic ecosystems and the ecological complexes of which they are part; this includes diversity within species, between species and of ecosystems' (Article 2). The Convention contains 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. (Article 1)

The CBD is generally considered to be a framework convention that 'creates a global structure to promote continued international cooperation and to support national implementation'; that allows for its further development through the negotiation of annexes and protocols; and that builds upon existing agreements rather than absorbing them (McGraw, 2002, pp20–22). It emphasizes the development of national biodiversity strategies and action plans as the basis for each country's obligations (Article 6(a)): 'A national strategy will reflect how the country intends to fulfil the objectives of the Convention in light of specific national circumstances, and the related action plans will constitute the sequence of steps to be taken to meet these goals.'² This approach was advocated initially by the British delegation during the Convention's negotiations, in contrast to the strong desire of France for a more supra-national, top–down approach of global lists of priority areas and species in need of protection (McConnell, 1996).

The text of the Convention consists of a preamble, 42 articles and two annexes (Box 5.1). Since 2000, there has also been a subsidiary instrument – the Cartagena Protocol on Biosafety. The work of implementing the CBD is carried out by the Conference of the Parties (COP) and its subsidiary bodies (Box 5.2), as well as by the domestic implementation of the Convention by states. The CBD is legally binding for the countries that have ratified it. However, for the Convention to be implemented domestically, ratifying countries must adopt appropriate legislation and regulations or bring existing ones into harmony with it.

Key provisions of the CBD

The broad scope of the Convention means that it is impossible to explore all its provisions in detail. Instead, we shall focus on five areas: access to genetic resources and benefit sharing (ABS); traditional knowledge (TK), innovations and practices; technology transfer; agricultural biodiversity; and implementation, compliance and enforcement. This section concludes with a brief consideration of some other provisions in the Convention and their links to IPRs.

Access to genetic resources and benefit sharing

Article 15 of the Convention addresses 'Access to genetic resources'. Paragraph 1 of the article reaffirms the principle from Article 3 of the Convention of state sovereignty over resources. Importantly, however, these sovereign rights now extend to genetic resources (although one could argue that such rights were already implicit in international law prior to the creation of the Convention). The paragraph explicitly vests the authority to determine access to genetic resources with national governments, subject to national legislation. This paragraph helps to explain the rationale behind granting states sovereignty over their genetic resources:

Countries could now set the terms for access to these resources, thus allowing them to profit from their biodiversity, further encouraging conservation. The CBD was thus based on both a premise – that developing countries had an equitable right to their own resources – and a promise – that these resources could be used to generate financing for development and conservation. (Garforth and Cabrera, 2004, p7)

Article 15 is important, therefore, not just for its economic aspects related to benefit sharing but also for how these are intended to also support the conservation and sustainable use of biodiversity.

Paragraph 2 of the article states that each Party is to endeavour 'to create conditions to facilitate access to genetic resources'. As mentioned above, this can also be seen as a major shift in international law as no such obligation to facilitate access existed previously. While perhaps somewhat unclear in its wording, paragraph 3 of the article means that the provisions of Articles 15, 16 and 19 do not apply to genetic resources accessed prior to the entry into force of the Convention. Essentially, it incorporates the principle of non-retroactivity, in other words that new legal rules and international agreements do not apply to past actions (Glowka et al, 1994, p79). As will be discussed below, Article 15(3) left open the question of what ABS rules should apply to ex-situ collections of genetic resources accessed prior to the creation of the Convention.

Safeguarding Biodiversity

Article 15 also states the general principles on which access must be granted, namely mutually agreed terms and prior informed consent (paragraphs 4 and 5). Paragraph 7 requires the Parties to the Convention to take measures for sharing the benefits from the use of genetic resources with the Party providing access to such resources. The Convention implies that the specific bargain between access to the resources and the sharing of benefits will be open for negotiation between the individual user and provider. For this reason, the Convention is said to favour the negotiation of bilateral ABS contracts between resource

provider and resource user. Finally, under paragraph 6, research based on genetic resources provided by Parties to the Convention should involve the full participation of such Parties and, where possible, be conducted in these Parties.

Access to genetic resources and benefit sharing is intimately connected to agriculture and food issues, although most of the CBD negotiators came from ministries of environment rather than ministries of agriculture. They had little knowledge of the characteristics of genetic resources for food and agriculture and all countries' interdependence on one another for these resources (Bragdon, 2004, p15; see also Chapter 6). For these negotiators, the classic ABS scenario involved scientists searching the rainforest for an organism that may contain the next cure for cancer or AIDS. Yet genetic resources and genetic diversity are also of critical importance in agriculture. That said, however, the ABS principles in the CBD are not the only ones that address access to genetic resources for food and agriculture and consequent benefit sharing.

When the negotiators of the CBD agreed in Nairobi in May 1992 on the text of the Convention to be advanced to the Earth Summit, they also adopted a resolution on 'The Interrelationship between the Convention on Biological Diversity and the Promotion of Sustainable Agriculture'. This resolution recognized:

… the need to seek solutions to outstanding matters concerning plant genetic resources within the Global System for the Conservation and Sustainable Use of Plant Genetic Resources for Food and Sustainable Agriculture, in particular: (a) access to ex-situ collections not acquired in accordance with this Convention; and (b) the question of farmers' rights (paragraph 4).

To this end, the FAO began negotiations in the mid-1990s to turn the IU into a binding treaty that is in harmony with the CBD. The result was the International Treaty on Plant Genetic Resources for Food and Agriculture. The Treaty is discussed in more detail in Chapter 6, but it is important here to note its relationship to the ABS provisions of the CBD. The Treaty creates a Multilateral System of Access and benefit sharing that covers the 35 food crop species and 29 forage species listed in Annex I to the Treaty. While ABS under the Treaty is still founded on the principle of state sovereignty over genetic resources (Article 10), access to the genetic resources in the Treaty's Multilateral System is done in accordance with a standard Material Transfer Agreement that also sets the terms for benefit sharing. Individual contract negotiations for each instance of access and benefit sharing are thus no longer required for the species listed in Annex I. This responds to the concern that the transaction costs for bilateral negotiations between providers and users of genetic resources would be so high under the CBD that they would inhibit plant breeding, inadvertently jeopardizing food security. Instead, the Treaty, rather than the CBD, now sets the rules for access to and benefit sharing from these specific crops and forages (see also Chapter 6; Moore and Tymowski, 2005; Garforth and Frison, 2007; Bragdon, 2004).

That said, there are any number of genetic resources that are relevant to food and agriculture that are not covered by the Treaty's Multilateral System. This includes plant genetic resources not listed in Annex I to the Treaty as well as animal genetic resources and aquatic genetic resources, among others (Box 5.3).

TK, innovations and practices

Another key provision in the CBD is Article 8(j), which obliges the Parties to the Convention, subject to their national legislation, to:

… respect, preserve and maintain knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity, promote their wider application with the approval and involvement of the holders of such knowledge, innovations and practices, and encourage the equitable sharing of the benefits arising from the utilization of such knowledge, innovations and practices.

This provision is included in the article on 'in-situ conservation' and is frequently summarized as addressing TK, innovations and practices of indigenous and local communities.

The implementation of Article 8(j) has covered a number of different areas including links to Article 15 on ABS. The TK of indigenous peoples and local communities can be very valuable in helping to identify genetic resources of potential interest for research programmes and product development. Furthermore, because of their long-term association with, as well as sustainable use and management of, their local environment, indigenous peoples and local communities may themselves have contributed to the development of the genetic resources. The CBD recognizes state sovereignty over genetic resources; however, this state authority does not extend to TK. Parties are required to respect, preserve and maintain TK with the approval and involvement of the knowledge holders, which are the indigenous peoples and/or local communities themselves. In implementing this provision, Parties such as Peru and the Philippines have required those seeking access to TK to do so on similar terms to those for accessing genetic resources, in other words requiring the prior informed consent of and the negotiation of mutually agreed terms with the knowledge holder.

At their fifth meeting in 2000, the Parties to the Convention adopted a programme of work for Article 8(j) (decision V/16). The programme of work contains a number of elements and tasks concerning participatory mechanisms for indigenous and local communities; the equitable sharing of benefits; monitoring; legal elements; traditional cultural practices for conservation and sustainable use; and exchange and dissemination of information.

At their seventh Conference in 2004, the Parties adopted 'Elements of a Plan of Action for the Retention of Traditional Knowledge, Innovations and Practices Embodying Traditional Lifestyles Relevant for the Conservation and Sustainable Use of Biological Diversity' (part E of decision VII/16). Work is focused on developing technical guidelines for documenting TK; developing indicators for the retention and use of TK; methods and measures to address the underlying causes of the loss of TK; and the development of a Code of Ethical Conduct to ensure respect for the cultural and intellectual heritage of indigenous and local communities. The Plan of Action includes the further development of sui generis systems to protect TK based on customary laws of indigenous peoples (SCBD, 2007, p2).

The Working Group on Article 8(j) is mandated to collaborate with the ABS Working Group in the negotiation of an international regime on access and benefit sharing (see below). The form of and process for this collaboration is yet to be determined (Box 5.4 and Chapter 8, Box 8.4). Finally, the Working Group on Article 8(j) has also contributed to the consideration of genetic use restriction technologies (GURTs), which is also covered in more depth below.

Access to and transfer of technology

Article 16 addresses access to and transfer of technologies that are relevant to the conservation and sustainable use of biodiversity or that make use of genetic resources and do not cause significant damage to the environment (Article 16(1)). This article contains the only explicit reference in the Convention to IP rights. The article aims to strike a balance between the need to secure access to and transfer of technology on the one hand, and to respect IPRs on the other.

Article 16(2) begins by stating that access to and transfer of technology 'to developing countries shall be provided and/or facilitated under fair and most favourable terms, including on concessional and preferential terms where mutually agreed, and, where necessary, in accordance with the financial mechanism established by Articles 20 and 21'. This or similar language has become something of a norm in international law. Similar commitments to technology transfer can be found in the UN Convention on Climate Change (Article 4(5)), the Montreal Protocol on Substances that Deplete the Ozone Layer (Article 10A), the UN Convention to Combat Desertification (Article 18(1)), and the Johannesburg Plan of Implementation from the World Summit on Sustainable Development (paragraph 105).

Paragraph 2 of Article 16 goes on to provide that for technology subject to patents or other IPRs, such access and transfer must be provided 'on terms which recognize and are consistent with the adequate and effective protection of IPRs'. The inclusion of the phrase 'adequate and effective' makes a direct link to the TRIPS Agreement, which was being concluded at the same time the CBD was finalized:³

According to the preamble of the TRIPS Agreement … the agreement was inspired by the need for new rules and disciplines in a number of areas relevant to IP, including adequate standards concerning the availability, scope and use of IPRs, as well as effective means to enforce them. (Glowka et al, 1994, p89; see also the first recital of the preamble to TRIPS as well as paragraphs (b), (c) and (d) of the second recital).

The terms 'adequate' and 'effective' are not defined in either the TRIPS Agreement or the CBD. One interpretation of 'adequate' is that it reflects the intention of the drafters 'not to create the system of IPR protection that would be considered "optimum" by particular right holders groups, but one that is adequate to protect the basic integrity of the trading system' (UNCTAD-ICTSD, 2005, p10). The lack of clarity over these terms has created tension between developed and developing countries, with the former group wishing to maintain its competitive technological edge and the latter group desiring to gain access to technology and also asserting that the level of IP protection 'should be tailored to a country's economic and technological development', the rationale being that standards of protection that are too high will hinder a country's development (Glowka et al, 1994, pp89 and 91). The situation has evolved since the negotiation of the Convention, however, and developed and developing countries should not be regarded as discrete blocs with homogeneous positions. Alliances between North and South can and do occur.

Paragraph 4 of Article 16 of the CBD requires each Party to take measures with the objective that the private sector will facilitate 'access to, joint development and transfer of technology … for the benefit of both governmental institutions and the private sector of developing countries and in this regard shall abide by the obligations included in paragraphs 1, 2 and 3 above'.

The final paragraph of Article 16 attempts to provide a counterbalance to paragraph 2. It states that the Parties shall cooperate over IPRs, subject to national legislation and international law, 'in order to ensure that such rights are supportive of and do not run counter to [the Convention's] objectives'. The article as a whole attempts to reconcile two very different perspectives on IPRs and in the process creates rather ambiguous language. Perhaps as a testimony to its ambiguity, the biotechnology industry has worried that the protection is too weak (Rhein, 1992)⁴, while some civil society organizations claim the language is too strong. Many developing countries argue that the application of existing IP systems hinders the transfer of technology to the developing world and unfairly disregards the contributions of generations of farmers and indigenous peoples to the world's plant genetic resources, which underpin global food security. These countries have objected to the expansion of IPRs over new crop varieties and other products based on genetic resources, and they proposed that the Convention provide for, or authorize, restrictions on IPRs. Some developed countries, on the other hand, argue that strong universal protection of IPRs would stimulate technology and investment in research and development in developing countries, indirectly increasing the incentives to conserve biological diversity (Fowler et al, 2001, p479). The language on which negotiators eventually agreed does not entirely resolve these differing perspectives on the role of IPRs in achieving the Convention's objectives (UNESCO, 2002).

At their seventh meeting in 2004, the Conference of the Parties adopted a programme of work on technology transfer and technological and scientific cooperation (annex to decision VII/29) with four elements: technology assessments, information systems, creating enabling environments, and capacity building and enhancement. Each element has a number of objectives, operational targets and activities. Activities include such things as preparing transparent impact assessments and risk analysis of the potential benefits, risks and associated costs of the introduction of technologies (paragraph 1.2.1); implementing proposals to enhance the Clearing-House Mechanism as a central mechanism in technology transfer (paragraph 2.1.4); preparing technical studies on the role of IPRs in technology transfer (paragraph 3.1.1); and providing financial and technical support as well as training to enable the conduct of national technology assessments (paragraph 4.1.1). Implementation of this programme of work is still in its early stages, although the Secretariat has prepared a draft technical study responding to paragraph 3.1.1 (CBD, 2006c).

Agricultural biodiversity

The CBD's scope is all types of biodiversity and there is no one article in the Convention that relates specifically to agricultural biodiversity. Countries recognized the interrelationship between the Convention and the promotion of sustainable agriculture in Resolution 3 of the Nairobi Final Act by which the final text of the CBD was adopted (see above). Consideration of agricultural biodiversity by the Conference of the Parties has covered a broad range of topics, including pollinators, soil biodiversity, animal genetic resources, trade liberalization and GURTs. Much of the work on agricultural biodiversity under the Convention has been carried out in collaboration with the FAO. Furthermore, with the conclusion at the FAO of the International Treaty on Plant Genetic Resources for Food and Agriculture, the Parties to the CBD recognized the important role the IT will play, in harmony with the CBD:

… for the conservation and sustainable utilization of this important component of agricultural biological diversity, for facilitated access to plant genetic resources for food and agriculture, and for the fair and equitable sharing of the benefits arising out of their utilization. (decision VI/6, paragraph 2)

In decision V/5, the Parties adopted a multi-year programme of work on agricultural biodiversity. The decision describes the scope of agricultural biodiversity as including:

… all components of biological diversity of relevance to food and agriculture, and all components of biological diversity that constitute the agro-ecosystem: the variety and variability of animals, plants and micro-organisms, at the genetic, species and ecosystem levels, which are necessary to sustain key functions of the agro-ecosystem, its structure and processes. (paragraph 1 of the Appendix to Annex 5 to decision V/5)

The objectives of the programme of work are:

• to promote the positive effects and mitigate the negative impacts of agricultural systems and practices on biological diversity in agro-ecosystems and their interface with other ecosystems;
  
  
• to promote the conservation and sustainable use of genetic resources of actual and potential value for food and agriculture; and
  
  
• to promote the fair and equitable sharing of benefits arising out of the use of genetic resources (paragraph 2 of Annex 5).

The programme of work includes four elements: assessments, adaptive management, capacity building and mainstreaming, although it is scheduled for an in-depth review at the ninth Conference of the Parties in 2008. While it is impossible to consider all aspects of agricultural biodiversity addressed by the Convention, a few are particularly relevant in the context of this book, notably GURTs.

Genetic use restriction technologies

GURTs (Box 5.5) first came to public attention in the late 1990s with a US patent on genetically modified plants that produced sterile seeds.

GURTs are not commercially available, perhaps in part because of decisions taken by the Parties to the CBD. In the decision of the Fifth COP (COP-5), the Parties adopted what is frequently considered to be a de facto moratorium on the use of GURTs. The Parties recommended that:

… in the current absence of reliable data on GURTs, without which there is an inadequate basis on which to assess their potential risks, and in accordance with the precautionary approach, products incorporating such technologies should not be approved by Parties for field testing until appropriate scientific data can justify such testing, and for commercial use until appropriate, authorized and strictly controlled scientific assessments with regard to, inter alia, their ecological and socioeconomic impacts and any adverse effects for biological diversity, food security and human health have been carried out in a transparent manner and the conditions for their safe and beneficial use validated. (decision V/5, paragraph 23)

Since this decision, there has been an ongoing tug of war between civil society groups who seek to maintain the moratorium and who call for a complete and outright ban on GURTs and certain governments, such as those of Australia, Canada, New Zealand and the US, which have advocated allowing case-by-case assessments of whether plants incorporating GURTs could be used. At COP-8 in 2006, the Parties reaffirmed the COP-5 decision on GURTs (decision VIII/23, part C, paragraph 1). It seems unlikely, however, that this is the end of the debate, particularly as the COP-8 decision calls for further research on the potential impacts of GURTs.

Implementation, compliance and enforcement

As a framework for international cooperation on biodiversity, the CBD relies on its Parties (national governments) to adopt or change legislation to give effect to the Convention. The terms of the CBD are legally binding on its country Parties, but the Convention's provisions do not generally set specific requirements to be undertaken by them. This is unlike other international agreements, such as the Convention on International Trade in Endangered Species of Fauna and Flora (CITES), which has specific trade restrictions and requirements for specific lists of species. The CBD sets general requirements to meet its three objectives and then largely leaves it to individual states to determine how best to implement these provisions in their respective jurisdictions (McGraw, 2002, pp20–21). A number of these requirements are qualified by phrases such as 'as far as possible and appropriate' and 'subject to its national legislation', and some ascribe the near-universal ratification of the Convention to its lack of effective means of monitoring or enforcing compliance with its provisions (McGraw, 2002, p24).

The CBD does not include a specific compliance mechanism akin to the Compliance Committee under the Biosafety Protocol (discussed in more detail below). That said, there are mechanisms for dispute settlement as well as a provision on liability and redress. Article 27 addresses the settlement of disputes. It creates a graduated response to resolving disputes, first requiring the parties concerned to seek a solution by negotiation, then allowing a third party to mediate or provide good offices if negotiation has not been successful. Paragraph 3 allows the Parties to agree to submit disputes to arbitration in accordance with Part 1 of Annex II to the Convention and/or to the jurisdiction of the International Court of Justice. If the parties to a dispute have not submitted to either of these procedures, the dispute is to be submitted to conciliation in accordance with Part 2 of Annex II unless the parties agree otherwise. None of these dispute settlement mechanisms has been used to date, perhaps because the Convention leaves much of the specifics of its implementation to be determined by each country in light of its own domestic circumstances.

If a dispute under the CBD were ever to be decided by the International Court of Justice, the losing party to the dispute would not necessarily face economic sanctions for not complying with the Court's ruling. This lack of economic consequences for non-compliance with the CBD (and many other multilateral environmental agreements, with notable exceptions such as CITES) is frequently said to give the Convention less 'bite' than the dispute settlement mechanism under the WTO, which allows for compensation and the suspension of concessions in cases of non-compliance with a ruling of one of its dispute settlement bodies (Article 22 of the Dispute Settlement Understanding). There are a number of disad-

vantages to the dispute settlement mechanism of the WTO, however, and it should not necessarily be regarded as a model to be followed elsewhere (Charnovitz, 2001). Rather than rely on coercive measures as does the WTO, the CBD and other environmental agreements tend to use positive incentives and transparency or 'sunshine' methods to encourage compliance (Weiss, 2000, p463).

Article 14(2) of the CBD requires the COP to examine, 'on the basis of studies to be carried out, the issue of liability and redress, including restoration and compensation, for damage to biological diversity, except where such liability is a purely internal matter'. To date, the Parties have largely engaged in an information gathering exercise on legislation, measures, agreements and case studies relating to liability and redress for damage to biological diversity and have held two meetings of experts to discuss the issue and review information. It seems unlikely that any sort of more formal liability and redress mechanism will be negotiated for the Convention itself, although important liability and redress negotiations are ongoing under the Biosafety Protocol (see below).

Leaving states to implement measures to achieve the Convention's three objectives also places the onus on these states to ensure compliance with their domestic measures. This has created a great deal of frustration for developing countries which face difficulties in monitoring and enforcing the terms of ABS agreements negotiated under their national laws. As agreements in private international law, ABS contracts are not generally subject to the dispute settlement provisions of the CBD.⁵

Technology, research and benefit sharing

A number of other provisions in the Convention involve technology, research and the sharing of benefits and could also relate to IPRs. These include Article 12(c), which deals with research and training and promotion and cooperation 'in the use of scientific advances in biological diversity research in developing methods for conservation and sustainable use of biological resources'; Article 17, which deals with exchange of information; and Article 18, which covers technical and scientific cooperation.

In their decision on 'Scientific and Technical Cooperation and the Clearing-house Mechanism', the Parties at their eighth Conference in 2006 invited 'Parties and other Governments, as appropriate, to provide free and open access to all past, present and future public-good research results, assessments, maps and databases on biodiversity, in accordance with national and international legislation' (decision VIII/11, paragraph 3). This decision points to the growing links being made between copyright, open access to research and publications, and biodiversity (Box 5.6 and Chapter 8).

Article 19 on the 'handling of biotechnology and distribution of its benefits' also contains provisions with links to IPRs. Article 19(1) provides that Parties shall take appropriate measures to provide for the effective participation in biotechnological research by Parties, especially developing countries, that provide the genetic resources for such research, in such Parties where feasible. Article 19(2) requires Parties to 'take all practicable measures to promote and advance priority access on a fair and equitable basis' for Parties providing genetic resources, especially developing countries, to 'the results and benefits arising from biotechnologies based upon [those] genetic resources … on mutually agreed terms'.

IPRs are also relevant to the implementation of Article 10, which requires Parties, as far as possible and as appropriate, to integrate consideration of the conservation and sustainable use of biological resources into national decision making and to adopt measures relating to the use of biological resources to avoid or minimize effects on biological diversity (Article 10(a) and (b)). The article also requires Parties to 'as far as possible and as appropriate … [p]rotect and encourage customary use of biological resources in accordance with traditional cultural practices that are compatible with conservation or sustainable use requirements' (Article 10(c)).

Ongoing processes

It may appear as though an international agreement such as the CBD is set in stone once countries have agreed to it but, in fact, it continues to evolve as countries undertake domestic implementation, the Parties adopt new decisions, developments transpire in other related fora and more information about biodiversity is acquired. One such major evolutionary development in the history of the

CBD is the negotiation and adoption of the Biosafety Protocol, discussed below. A current ongoing process is the negotiation of an international regime on ABS.

An international regime on ABS?

As described above, the ABS provisions in the CBD are very general, largely leaving it to Parties to develop and implement more specific rules on ABS domestically and also leaving the terms of ABS contracts to negotiation between the providers and users. In the mid-1990s, as some developing countries, such as the Philippines and Costa Rica, began to try to create national ABS systems, they found it to be an exceedingly complex exercise, requiring the collaboration of experts in science, law and business. Many developing countries lacked the capacity to bring these experts together and so were unable to implement the ABS provisions of the CBD. Furthermore, countries that were able to create domestic regimes faced challenges in their implementation. One such challenge is where access to a genetic resource was granted but the resource was removed from the country's jurisdiction. Most developing countries had little ability to track how such resources were subsequently used or to monitor whether the terms of any negotiated ABS contract were being complied with by the user of the genetic resources. Developing countries also faced a lack of capacity and experience in negotiating access contracts and were vulnerable to agreeing to terms that were not 'fair and equitable'. With much genetic diversity being shared among countries, bioprospectors seeking access might also be able to pit developing countries against each other in a race to the bottom to offer the best terms and gain at least some benefits (see Chapter 7 for a discussion of biopiracy, a related but controversial term). Developed countries, where most of the commercial users of genetic resources are located, had little interest in creating rules that would place obligations on these users to address the concerns of developing countries. They preferred ABS to be purely based on contractual terms negotiated between the providers and the users.

At the CBD, early work on the implementation of ABS provisions focused on information gathering. The Parties began to move beyond this stage at their fifth conference in 2000 when they created the Ad Hoc Open-Ended Working Group on ABS 'to develop guidelines and other approaches' on ABS to help the Parties and stakeholders. At its first meeting in 2001, the Working Group drafted the 'Bonn Guidelines on Access to Genetic Resources and the Fair and Equitable Sharing of the Benefits arising from their Utilization', which were finalized and adopted at COP-6 in 2002. The voluntary guidelines expand upon the concepts of prior informed consent and mutually agreed terms as contained in the CBD. They also provide a list of suggested elements for inclusion in material transfer agreements and list monetary and non-monetary options for benefit sharing. The Bonn Guidelines aimed, among other things, to contribute to the conservation and sustainable use of biodiversity, promote technology transfer, contribute to 'the development by Parties of mechanisms and ABS regimes that recognize the protection of TK, innovations and practices of indigenous and local communities, in accordance with domestic laws and relevant international instruments', and contribute to poverty alleviation and supporting the realization of human food security, health and cultural integrity (paragraphs 11(a), (g), (j) and (k)).

The Bonn Guidelines have proven useful for countries developing national systems to govern ABS and have been explicitly used by Australia and Kenya in the creation of their legislative frameworks. The Bonn Guidelines make little to no mention, however, of obligations on users of genetic resources or issues of enforcement. Growing frustration with the lack

of obligations on users of genetic resources led to the formation in February 2002 of the Like-Minded Megadiverse Countries (LMMC), a coalition of developing countries that represents more than 70 per cent of global biodiversity and 45 per cent of the world's population, spanning a number of geographical regions.⁶ The initial member countries were Brazil, China, Colombia, Costa Rica, Ecuador, India, Indonesia, Kenya, Mexico, Peru, South Africa and Venezuela. Since then, Bolivia, the Democratic Republic of the Congo, Madagascar, Malaysia and the Philippines have also joined. One of the objectives of the LMMC is the creation of binding international rules on ABS.⁷ The group was instrumental in obtaining two commitments on ABS in the Johannesburg Plan of Implementation from the World Summit on Sustainable Development held in September 2002. Chapter IV of the Plan addresses the protection and management of the natural resource base of economic and social development. Paragraph 44 of that chapter focuses on biodiversity, and subsection (n) encourages the implementation and further development of the Bonn Guidelines. Subsection (o) calls for action to '[n]egotiate 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'.

At COP-7 to the CBD, in February 2004, the Parties agreed to launch the negotiations and also set the terms of reference on which the negotiations are to be based (decision VII/19, part D). There is a list of over 20 elements to be considered in the terms of reference for the negotiations including '(xiv) Disclosure of origin/source/legal provenance of genetic resources and associated TK in applications for intellectual property rights'.

The negotiations on the international regime began at the third and fourth meetings of the ABS Working Group which were held in Bangkok in 2005 and Grenada in 2006 respectively. Negotiations in Grenada were particularly acrimonious, with the African Group tabling a draft protocol on ABS that it sought to be used as the basis of negotiations and the Spanish chair of the meeting tabling a Chair's text. A number of developed countries – such as Australia, New Zealand, Japan, Canada, the EU and Switzerland – felt that the Chair's text and revised versions thereof did not adequately address their views and moved too quickly towards a legally binding regime (IISD, 2006b). A text full of square brackets marking the areas of disagreement was forwarded to COP-8 in Curitiba, Brazil, in March 2006.

In addition to government positions in the ABS negotiations, industry has also begun to take an increasingly vocal role. The International Chamber of Commerce (ICC) has been following ABS negotiations for a number of years and now has a task force on ABS that includes three major industries that use genetic resources: the agricultural sector, the industrial use of microbial resources and the pharmaceutical industry. At the Grenada meeting of the ABS Working Group, the ICC expressed the view that a 'one size fits all' approach to genetic resources would not work given the different interests and needs of different sectors (CBD, 2006b, paragraph 28). While there may be some merit to this view, taking a sector-by-sector approach to regulating genetic resources could also create a number of problems. It could result in a confusing web of rules that would be impractical to apply given that it is difficult if not impossible to predict at the time of access the different fields in which a genetic resource might be used. The sector-by-sector approach may also be a negotiating tactic to divide the discussions into many small parts, diluting the energy and capacity of developing countries to participate. (See Chapter 6 for a discussion of the IT and its ABS rules specific to plant genetic resources for food and agriculture.)

At COP-8, the Parties instructed the ABS Working Group 'to complete its work at the earliest possible time before the tenth meeting of the Parties' in Nagoya, Japan, in 2010 (decision VIII/4, paragraph 6). What exactly is meant by the ABS Working Group 'completing its work' is left open to interpretation. The Parties named two permanent co-chairs – Tim Hodges of Canada and Fernando Casas of Colombia – to lead the ABS Working Group through the negotiations. They also agreed to forward the text from Grenada to the next meeting of the ABS Working Group, but the controversy that surrounds the text and the lack of 'ownership' vested in it by the two co-chairs suggests that it is unlikely to remain an option.

More broadly, these negotiations can be understood as the latest salvo by some developing countries in their attempts to bring balance to the world economic system. Precursors to the ABS negotiations can be found in the debates over revisions to the Paris Convention for the Protection of Industrial Property at WIPO (see Chapters 3 and 4), the negotiation of an International Code of Conduct on the Transfer of Technology at UNCTAD, and the General Assembly Resolution on the Declaration for the Establishment of a New International Economic Order (Sell, 1998). It remains to be seen whether developing countries will be more successful in extracting concessions from developed countries in the ABS negotiations than they were in these previous, largely unsuccessful undertakings.

Monitoring, enforcement and compliance: Certificates and disclosure

The tools and mechanisms to enforce the Convention – an instrument of public international law – discussed above do not necessarily apply to the enforcement of contracts, which are instruments of private international law. Developing countries with national ABS systems cannot easily monitor the use of genetic resources once they leave their jurisdiction and ensure compliance with the terms agreed to in a contract. The lack of user measures in the Bonn Guidelines, the lack of binding obligations on users of genetic resources and the unwillingness of countries that are home to commercial users of genetic resources to place obligations on these users has created a great deal of frustration among developing countries. At the CBD, this frustration has manifested itself in the push to negotiate an international regime on ABS, while in WIPO and the WTO it has led to calls for mandatory requirements for disclosure in patent applications (see Chapters 3, 4 and 7).

While these debates continue, the Parties to the CBD are considering a measure that could support disclosure requirements: an international certificates scheme. The general idea is that an access provider would also provide the user with a certificate attesting to the fact that the user gained access in accordance with the provider's rules on prior informed consent and on mutually agreed terms. Users could then use these certificates to meet any disclosure requirements in the patent system or product approval process, or in the requirements of funding agencies or publishers, and so forth. While disclosure and certificates are not the same thing – each could exist without the other – many of the debates about disclosure are echoed in the discussion of certificates (Box 5.7). Should a certificate attest to the origin, the source or the legal provenance of the genetic resource in question? Should it also cover TK? Should it be required in patent applications?

In January 2007, the CBD convened a meeting of a Group of Technical Experts on an Internationally Recognized Certificate of Origin/Source/Legal Provenance. The Group explored and elaborated possible options for the form, intent and functioning of such a certificate and analysed its practicality, feasibility, costs and benefits (CBD, 2007b, paragraph 13). The Group 'recognized that the basic role of the certificate is to provide evidence of compliance with national ABS regimes. Thus it found it practical to refer to the certificate as a certificate of compliance with national law, in accordance with the Convention' (CBD, 2007b, paragraph 7 of annex). This change in terminology circumvents the question of origin/source/legal provenance without actually resolving which of these would be certified under a certification system. While the Group explored and elaborated options, the decisions on which options should be pursued are left for the ABS Working Group, which, at the time of writing, has not yet considered the outcomes from the meeting of the Group of Technical Experts.

Industry has also weighed in on both the issues of disclosure and certificates. Most industry organizations are generally opposed to mandatory requirements for the disclosure of origin in patent applications. In September 2005, the US biotechnology industry formed a new lobby group – the American Bioindustry Alliance (ABIA) – under the leadership of Jacques Gorlin, one of a handful of key architects of the TRIPS Agreement. The ABIA has described its activities as 'developing industry positions and programmes to counter the unprecedented global threat to biotechnology patents at the WTO Hong Kong Ministerial Meeting … and beyond' (Garforth, 2006; see also New, 2006).⁸ The group is opposed to mandatory requirements for the disclosure of origin in patent applications and is active at the WTO, the CBD and WIPO in advocating this perspective. Industry views on certificates appear to be less hard-line, as illustrated by the submissions to the CBD's Group of Technical Experts (CBD, 2006a). Industry organizations have a great many questions about how a certificates system may function but may be willing to support some sort of certificates mechanism if it results in legal certainty and does not create undue administrative burdens.

The Cartagena Protocol on Biosafety⁹

One development in the evolution of the CBD was the creation of the Cartagena Protocol on Biosafety. The Protocol is a subsidiary instrument of the CBD and is also an evolving instrument with important links to food security and IP rights as well as biodiversity. Most fundamentally, the commercial development of genetically modified organisms (GMOs) owes much to the extension of patentability and companies' aggressive enforcement of these patent rights (see Chapter 1). What follows is an overview of the negotiations that led to the creation of the Protocol and a discussion of key provisions and ongoing processes therein.

The negotiations

The negotiation of the CBD began at a time when the potential of biotechnology was just beginning to be recognized. From the start, developing countries insisted that biotechnology be one of the key issues addressed in the Convention (McGraw, 2002, p34). This insistence was successful and led to the inclusion in the Convention of Article 19 on the 'handling of biotechnology and distribution of its benefits'. In general, the article provides that Parties to the CBD are to take measures to include countries that provide genetic resources in biotechnology research activities, to share access to the results and benefits of biotechnology, and to provide information about living modified organisms to Parties where they are to be introduced. Paragraph 3 of Article 19 obliges the Parties to the Convention to:

… consider the need for and modalities of a protocol setting out appropriate procedures, including, in particular, advance informed agreement, in the field of the safe transfer, handling and use of any living modified organism resulting from biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity.

This paragraph was somewhat controversial during the negotiations as some countries wanted to make the development of a protocol mandatory (Mackenzie et al, 2003, paragraph 11).

At COP-1 to the CBD, the Parties authorized two meetings to discuss the need for a protocol. The second of these meetings, by the Ad Hoc Open-Ended Group of Experts, included support by a large majority of the delegations present for the negotiation of a biosafety protocol. At COP-2 in 1995, the Parties agreed to establish the Ad Hoc Working Group on Biosafety to elaborate a protocol on biosafety and for it to endeavour to complete its work sometime in 1998.

In the end, it took until 2000 for the negotiating countries to reach agreement on the text of a protocol. The negotiations were rocky and reached the brink of failure when there was no agreement at a February 1999 meeting in Cartagena, Colombia. In particular, the negotiating bloc of the Miami Group of countries – Canada, the US, Australia, Uruguay, Chile and Argentina, the leading agricultural exporters with the most to lose from strict regulation of GMOs – pressed for the weakest and narrowest protocol possible, nearly scuttling the negotiations at the February 1999 meeting. An extraordinary Conference of the Parties was called for January 2000 in Montreal and consensus was finally achieved. Three and a half years later, in September 2003, the Cartagena Protocol on Biosafety ('Biosafety Protocol' or 'the Protocol') entered into force.

Some of the most contentious issues during the negotiations included the scope of the advance informed agreement procedure under the Protocol and the types of organisms it would cover; inclusion of the precautionary principle in the operational text of the Protocol (Box 5.8); the allowance for socioeconomic considerations in decision making under the Protocol; and the relationship between the Protocol and other international agreements, particularly those of the WTO. In this regard, the CBD has requested but has not yet been granted observer status in both the Sanitary and Phytosanitary and Technical Barriers to Trade Committees of the WTO.

The Protocol

The term biosafety is not defined in either the Protocol or the CBD. According to the CBD Secretariat, 'Biosafety is a term used to describe efforts to reduce and eliminate the potential risks resulting from biotechnology and its products.'¹⁰ Potential risks include the possibility that a genetically modified organism may out-compete other organisms once introduced into the environment, becoming a pest, and that genes introduced into one organism may spread to other organisms, causing environmental, economic and/or social damage.

The Protocol focuses its efforts on reducing the potential risks of LMOs resulting from modern biotechnology. The term LMO stands in contrast to the more frequently used 'genetically modified organism' and it is carefully defined in the Protocol as 'any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology'. The Protocol is a subsidiary instrument of the CBD and so only Parties to the Convention may become Parties to the Protocol (Box 5.9). There are 143 Parties to the Protocol as of late 2007.

The Protocol is a complex and intricate instrument and our focus is on two of its decision-making procedures for LMOs. The scope and terms of these procedures are intimately linked with the economics that were at stake during the negotiations.

The Protocol divides LMOs into several categories. The two main groups of concern are LMOs that are intended for intentional introduction into the environment of an importing Party and LMOs for use as food, feed or for processing (LMOs-FFP):

[LMOs-FFP include] such widely traded commodities as genetically modified corn, soy, wheat, canola and tomatoes. Those opposed to including commodities in the Protocol had argued that commodities, since they are not intended for introduction into the environment, pose no threat to biodiversity and should not be the subject of a protocol to the CBD. LMOs intended for introduction into the environment, on the other hand – such as seeds and micro-organisms – can mutate, migrate and multiply, and therefore may pose unexpected threats to native species. Others argued that it was impossible to ensure that LMO-FFPs would not be introduced to the environment, whatever the intent. (Cosbey and Burgiel, 2000, p4).

By the time the negotiators met in Cartagena in 1999, they had agreed that LMOs-FFP would be included in the scope of the Protocol. The remaining question was whether they would be subject to the Protocol's advance informed agreement (AIA) procedure.

The Miami Group's aim in Cartagena was to keep LMOs-FFP outside the AIA procedure, whereas the Like-Minded Group (see Box 5.8) was similarly insistent that LMOs-FFP should be subject to it or a similarly robust procedure (SCBD, no date, p42). The final text represents a compromise but was essentially a 'win' for the Miami Group as the Protocol creates a separate procedure for LMOs-FFP, a procedure that is less onerous for exporters than the AIA procedure.

The distinction between LMOs that are for intentional introduction into the environment and those that are not is somewhat of a legal fiction as LMOs in the latter category can easily wind up being released into the environment, regardless of intention (Box 5.10) The introduction of genetically modified commodities into an environment where they are not intended to be introduced raises a number of IP concerns. If a company has a patent on the gene that is spreading through the countryside, will the company be able to sue farmers for patent infringement and stop them from growing any crop that contains the gene? This scenario is not at all far-fetched given the case of Monsanto v. Schmeiser (discussed below) and Monsanto's actions over Argentinean exports of Roundup Ready soya (GRAIN, 2006a; see also Chapter 8, Box 8.8). The impacts that this sort of action could have on the livelihoods of subsistence farmers and the biodiversity they cultivate are potentially catastrophic. It can also mean that the introduction and spread of LMOs in the environment becomes a fait accomplish without the organism going through the necessary regulatory process.

LMOs that are intended for intentional introduction into the environment of an importing Party are subject to the AIA procedure (Articles 7–10). The aim of this procedure is to ensure that importing countries have the opportunity to assess 'the possible adverse effects of LMOs on the conservation and sustainable use of biological diversity, taking also into account risks to human health' (Article 15(1)). The procedure requires the Party that intends to export LMOs to notify, or to require the exporter to notify, the Party that is destined to be the importer (Article 8(1)). The notification must include, as a minimum, the information in Annex I to the Protocol, which includes descriptions of the organism in question, intended use of the organism and the regulatory status of the LMO in the country of export. The importing Party is then required to acknowledge receipt of the notification, including '[w]hether to proceed according to the domestic regulatory framework of the Party of import or according to the procedure specified in Article 10' (Article 9(2)(c)). Article 10, in turn, sets out a decision-making procedure that Parties can (but are not obliged to) use to determine whether to approve or prohibit the import, or request additional information. The procedure includes a risk assessment and allows the Party of import to use precaution to avoid or minimize the potential adverse effects of the LMO where there is scientific uncertainty. According to the information available on the BCH, the AIA procedure has been little used.¹¹

The procedure for LMOs-FFP is contained in Article 11 of the Protocol. The article requires a Party that makes a decision concerning domestic use of an LMO-FFP that may be subject to transboundary movement to notify the other Parties of the decision via the Biosafety Clearing-House. The procedure still allows countries to make their own decisions about the import of LMOs-FFP and these decisions can be based on precaution.

Key issues in the Protocol

As with the Convention, the final agreed text of the Protocol is not a static instrument. On two issues in particular (labelling plus liability and redress), negotiators were unable to reach agreement on substantive provisions and so included enabling clauses in the Protocol that called for further negotiation on these once the Protocol entered into force. These issues can be seen as part of the balancing requirements and risk sharing for those who benefit from IP-protected products and processes deriving from modern biotechnologies which they promote.

Labelling of shipments

Article 18 of the Protocol concerns 'handling, transport, packaging and identification'. Paragraph 2 of the article sets out the documentation requirements that must accompany shipments of different categories of LMOs. Most controversial is sub-paragraph (a), which, with its chapeau, reads:

Each Party shall take measures to require that documentation accompanying … LMOs that are intended for direct use as food or feed, or for processing, clearly identifies that they 'may contain' LMOs and are not intended for intentional introduction into the environment, as well as a contact point for further information. The Conference of the Parties serving as the meeting of the Parties to this Protocol shall take a decision on the detailed requirements for this purpose, including specification of their identity and any unique identification, no later than two years after the date of entry into force of this Protocol.

This sub-paragraph was the last issue to be agreed by the Extraordinary Conference of the Parties in Montreal in 2000 (SCBD, no date, p60). The controversy surrounds the meaning of the words 'may contain' and the extent to which they will enable countries to label LMOs or GMOs that are sold to consumers.

In the event the Parties were unable to reach agreement about Article 18.2(a) during the second meeting of the Parties to the Protocol held in Montreal in May–June 2005, due in large part to New Zealand and Brazil. This increased the pressure on the Parties at MOP-3 in Curitiba, Brazil, in 2006 to reach agreement, as another failure might seriously compromise the Protocol.

Long negotiating sessions among a few key players, including Ethiopia, Malaysia, Brazil, New Zealand, Mexico and the EU, resulted in decision BS-III/10. Paragraph 4 of the decision sets the 'detailed requirements' requested by Article 18.2(a). It requires Parties to the Protocol to ensure that documentation accompanying LMOs-FFP states, in cases where the identity of the LMOs is known, that the shipment contains such LMOs, and, in cases where the identity of the LMOs is not known, that the shipment may contain such LMOs. In paragraph 6 of the decision, the Parties acknowledge that the expression 'may contain' does not require a listing of LMOs other than those that constitute the shipment. Overall, the decision tries to balance the concerns and obligations of countries that are likely to be importing bulk shipments of commodities that could contain LMOs with the concerns and obligations of those likely to be exporting such shipments, some of whom are not Parties to the Protocol and so are not bound to comply by its provisions. It seems ironic, then, that New Zealand, which has one of the strictest domestic systems for the regulation of GMOs, was arguing for extremely weak rules at the international level. This illustrates the complexity of international processes and how a country's position may be influenced by a number of different interests, in this case New Zealand's high economic dependence on agricultural exports and its relationship with its trading partners, particularly the US.

Despite the text in decision BS-III/10, all is not what it seems, and the decision largely delays the issue yet again. It requires the Parties at their fifth meeting (in 2010) to review and assess experience gained with the implementation of paragraph 4, with a view to considering a decision at their sixth meeting to ensure that documentation accompanying LMOs-FFP covered by paragraph 4 clearly states that the shipment contains such LMOs (paragraph 7). So, while a decision has been adopted that ostensibly satisfies the demands of Article 18.2(a), the issue is by no means resolved and will continue to be debated by the Parties.

Liability and redress

According to the CBD Secretariat:

The term 'liability' is normally associated with the obligation under the applicable law to provide for compensation for damage resulting from an action for which that person is deemed responsible. Liability and redress in the context of the Protocol concerns the question of what would happen if the transboundary movement of living modified organisms … has caused damage.¹²

The Like-Minded Group insisted on the inclusion in the Protocol of provisions on liability and redress:

The motto 'no liability, no Protocol', displayed on blue-green badges, was adopted during the negotiations by delegates arguing for the inclusion in the protocol of some provision for liability and redress. It was intended to reinforce the message that if this subject were to be left out, the prospects for successfully finalizing a protocol would be minimal. Some of those less well disposed towards the ultimate success of the protocol negotiations also muttered the phrase to themselves, in hope rather than defiance, and at times the words looked like a forlorn prophecy rather than a clarion call to address this knotty issue. (Cook, 2002, p372)

As it became clear that negotiating substantive provisions on liability and redress would be time-consuming and delay the adoption of the Protocol as a whole, an enabling provision was included in the Protocol mandating MOP-1 to 'adopt a process with respect to the appropriate elaboration of international rules and procedures in the field of liability and redress for damage resulting from transboundary movements of living modified organisms'

(Article 27). At MOP-1, the Parties agreed to establish an Ad Hoc Open-Ended Working Group of Legal and Technical Experts on Liability and Redress. This enabling provision is somewhat analogous to Article 27.3(b) of TRIPS and its requirement for its own review four years after the entry into force of the WTO Agreement (see Chapter 3). Both provisions delay consideration of complicated issues and allow all sides in the negotiations to claim to have achieved something. These perceived achievements might well be contradictory, however, meaning that the US may claim that the Article 27.3(b) review provides for the elimination of any restrictions on patentability while developing countries might claim that it provides for the elimination of any requirements for the patentability of living organisms. Under the Protocol, developing countries can claim that Article 27 requires the negotiation of legally binding rules on liability and redress, while the main exporters of LMOs can claim that no such rules are mandated, feasible or desirable.

The Protocol's Working Group on Liability and Redress has a mandate to meet five times over four years. However, it is not specifically mandated to negotiate rules on liability and redress; rather it is, among other things, to elaborate options for elements of the rules and procedures referred to in Article 27 of the Protocol (decision BS-I/8, Annex).

To date, the Working Group has engaged in an exercise of compiling approaches, options and issues on rules and procedures for liability and redress. However, the difficult compromises have yet to be made and negotiations will truly take place during the final meetings of the Working Group and, in all likelihood, at MOP-4. It is even conceivable that the Parties will need to renew the mandate of the Working Group if it is unable to finalize its deliberations.

Perhaps the most fundamental point to be decided is the nature of the rules and procedures being discussed. The third meeting of the Working Group ended with an impassioned intervention from Malaysia, calling for a legally binding instrument. Anything less, it was stated, would be a betrayal of the trust of the developing countries who agreed to the compromise of the enabling provision in Article 27. Norway also spoke in favour of a legally binding regime in order to ensure consistent and predictable rules across jurisdictions. This could signal the emergence of an important North–South coalition. At the same time, however, while Principle 13 of the Rio Declaration urges the development of international liability rules, past experience with negotiating binding rules on liability has been less than positive. A number of instruments have taken many years to negotiate and to enter into force or have failed to enter into force altogether.¹³

Other key issues in the liability and redress negotiations include:

• The definition of damage. Will it be restricted to damage to biodiversity or the conservation and sustainable use of biodiversity (and if so, what does this mean)? Or will it encompass more traditional grounds, such as damage to the person or property, economic damage, or damage to the environment?
  
  
• The functional scope of the rules and procedures. Will the rules and procedures apply to damage resulting from the intentional transboundary movement of LMOs, unintentional transboundary movements, and/or illegal transboundary movements? Will they apply to damage within a Party, within a non-Party and/or beyond national jurisdiction?
  
  
• The standard of liability. Will liability be strict or will it require some proof of fault? It might be noted that patent law is a strict liability regime – simple infringement of a patent is sufficient to give rise to liability, with no fault being required (see Chapter 1, Box 1.6, and the discussion of Monsanto v. Schmeiser, below).
  
  
• Channelling of liability. Who can potentially be held liable? The developer,

the producer, the notifier, the exporter, the importer, the carrier, the supplier?

Balancing IPRs with responsibility for damage from LMOs

While the issue has not been considered in any detail during the deliberations of the Working Group, there is a connection to be made between liability for damage caused by LMOs and IPRs over these same organisms. More specifically, it is not the IPRs per se but the control they give to their owner that ties them to the question of liability (de Beer, 2007). The juxtaposition of two Canadian cases illustrates the point quite clearly.

In the first case, the Supreme Court of Canada's decision in Monsanto v. Schmeiser granted Monsanto expansive patent protection over the genetically modified gene and cell in its Roundup Ready canola. The Court's interpretation of the patent was expansive because while the patent only claimed the genetically modified gene and the cells containing the gene, the effect of the Court's decision was to give Monsanto patent protection over the entire plant. This was in spite of the fact that higher life forms such as plants are not patentable in Canada.¹⁴ A further outcome of Schmeiser was that it placed all of the burdens on the farmer to avoid infringement of the patent. Canadian patent law, like patent laws in many other countries, does not require a person to intend to infringe or even knowingly infringe a patent in order to be found liable. With Monsanto's patented genes spreading by natural means throughout the Canadian prairies, this rule places the onus on the farmer to monitor his fields for volunteer GM canola plants or the spread of the introduced genes. If and when the patented genes appear, the farmer must call the company to come and remove the plants. In Monsanto's case, at least, in order for the company to remove the plants, the farmer is required to sign a waiver that releases the company from any lawsuits 'associated with the products and forbids the grower from disclosing the terms of the settlement' (Pratt, 2005).¹⁵ Wilful blindness is not an option – if the farmer does not monitor his fields or call the company after having detected the genes, he faces the threat of patent infringement litigation. And if sued, it is the farmer who must rebut the presumption of use through an innocent bystander defence that the Supreme Court has said exists but has not defined (Garforth and Ainslie, 2006, pp470–471).

In the second case, Hoffman v. Monsanto, a group of organic farmers from Saskatchewan are attempting to launch a class action suit against Monsanto and Bayer for damages caused by the spread of the companies' genetically modified varieties of canola. Among other things, the farmers have grounded some of their allegations in the fact that Monsanto, in particular, continues to exercise control over the offending genes and cells through its IPRs and active assertion thereof. In essence, through their lawsuit the farmers are attempting to place some of the burdens for the consequences of GM plants back on the companies that developed them and profit from them.

To date, however, the farmers have been unsuccessful. The courts have refused to certify their class action, finding, among other things, that their causes of action would fail at trial. The combined effect of the Schmeiser and Hoffman decisions is somewhat paradoxical: 'Monsanto can exert unprecedented levels of control over things it could not patent, whilst simultaneously being able to deny that it has any control over the same product in the context of the common law or statute. This is an unacceptable incongruity' (Phillipson, 2005, p372). Rather than balancing the IPRs of the companies with a corresponding responsibility, the courts have added to the already heavy burden placed on Canadian farmers in the wake of Schmeiser. In addition to the burden of avoiding patent infringement, the farmer must now also bear the burden of damage (see also Box 1.6).

How has it come to pass that biotechnology companies can enjoy all the benefits of expansive patent protection without any obligations? Through the language of property: 'Patentees are quick to invoke the power of property rhetoric to expand and protect their rights, but when it comes to the liabilities ordinarily associated with ownership, the tune suddenly changes' (de Beer, 2007). Not all countries have the same history of case law as does Canada, however, so this disequilibrium between rights and responsibilities should not be regarded as the norm. It remains to be seen if and how these considerations might be incorporated into the activities of the Biosafety Protocol's Working Group on Liability and Redress.

Compliance

The Protocol addresses compliance (Article 34) and the Parties have set up a Compliance Committee (see Box 5.9). The Committee has 15 members, who are selected on the basis of regional representation and who serve in a personal capacity. The Committee is mandated to meet twice a year and can choose whether its meetings are open to observers. Its functions include identifying the specific circumstances and possible causes of individual cases of non-compliance referred to it; considering information submitted to it regarding compliance and non-compliance; providing advice and/or assistance to a Party 'on matters relating to compliance with a view to assisting it to comply with its obligations under the Protocol'; reviewing general issues of compliance; and taking measures or making recommendations to the MOP. While the Protocol has a more specific compliance mechanism than does the Convention, it still largely relies on the same strategies of transparency and positive incentives to try to effect compliance, as shown by the measures it and the MOP can take. The measures include providing advice, assistance and/or various capacity-building measures to the Party concerned and publishing cases of non-compliance in the Biosafety Clearing-House.¹⁶

To date, the Compliance Committee has not received any submissions about the compliance or non-compliance of a specific Party. It is even possible that the Committee will never receive a submission as the dictates of diplomacy would suggest that countries may prefer to seek more private solutions to any problems that arise between or among them. In this regard, there is no obligation on Parties requiring them to make submissions on instances of non-compliance if and when they are aware of them. Furthermore, with certain key exporters of LMOs (such as the US, Canada and Argentina) not being Parties to the Protocol, their actions are beyond the mandate of the Committee. In its meetings to date, the Committee has developed its rules of procedure and adopted a work plan, developed recommendations for consideration by the MOP, reviewed general issues of compliance, and reviewed information on measures concerning cases of repeated non-compliance.¹⁷

Conclusion

The Biosafety Protocol has already reached some key milestones. It has entered into force and the Parties have agreed to a decision on the detailed identification requirements for implementing Article 18.2(a) on documentation to accompany LMOs. It is still relatively early days for the Protocol, however, and key issues such as the rules and procedures on liability and redress remain to be resolved. The connection between IPRs and biosafety may be less obvious but is certainly present. Biosafety regulation is intended to address concerns about gene flow, but as introduced genes continue to spread through the environments where they have been released and also to spread from country to country, the IPRs over these genes give the proprietor companies increasing control over who can grow what, where and how. This has potentially serious consequences for farmers, food security and biodiversity, but these consequences have, to date, largely remained outside the deliberations under the Protocol.

Neither the Convention nor the Protocol are static instruments. Both are evolving. Furthermore, the way they evolve is not necessarily logical or rational but is highly dependent on politics. It is difficult to capture in writing the importance of the personalities involved in the negotiations. Meetings led by competent chairs will generally produce better results; when negotiators get along with one another – whether or not their positions on an issue are similar – they will more easily reach a compromise. Personality conflicts and power struggles over process can spell disaster. These are just some of the intangibles that feed into the eventual outcomes of negotiations.

The Convention on Biological Diversity and the Cartagena Protocol on Biosafety are pieces in a larger puzzle of international rules and negotiations on these issues. They should not and cannot be fully understood in isolation and so must be interpreted in light of the other chapters in this book. To this end, the next chapter turns to one of the newest agreements and its role in the IPRs, biodiversity and food security nexus.

Resources

The website of the Secretariat to the Convention can be found at www.cbd.int.

IUCN (The World Conservation Union) has produced two valuable guides, one to the Convention (Glowka et al, 1994) and the other to the Biosafety Protocol (Mackenzie et al, 2003).

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