Document(s) 11 of 20

This chapter examines the increasingly complex linkages between the various international negotiations in trade, environment, agriculture and intellectual property (IP) that govern the ownership and control of genetic resources discussed in Chapters 2–6. The diversity of negotiating constituencies and lack of policy coherence at all levels, in addition to the forum management strategies used by some countries, has resulted in an array of agreements that can have inconsistent or overlapping objectives. The various authors of the previous chapters identified what they saw as important linkages; those comments are drawn together, along with other linkages, in this chapter.

Introduction

Chapters 2–6 described how the scope of IP has expanded, through different multilateral agreements, to include genetic resources and associated knowledge for agriculture and food. Forum proliferation and the increasing complexity of the various international treaties create and contribute to controversies, conflicts, grey areas and other problems.

This chapter discusses the strategies being pursued to deepen global IP expansion and harmonization, such as forum management and bilateral and regional free-trade agreements, enforcement mechanisms, World Trade Organization (WTO) accessions and the implications for genetic resources. Next, it discusses the linkages around the harmonization of IP and the access and benefit sharing (ABS) of genetic resources and the way this is shaping how international instruments such as those discussed in Chapters 2–6 relate to each other. It then moves on to some of the broad problems identified with the approach of balancing the exchange of genetic resources with IP protection within an increasingly patent-dominated system. Finally, it briefly examines other linkages, such as some of the development and emerging human rights issues.

Strategies to Deepen IP Expansion and Harmonization

This section explores several strategies being pursued to expand and harmonize IP protection and their implications for genetic resources for food and agriculture.

Forum management and bilateral and regional trade agreements¹

Powerful countries and interests that are unable to get the level of IP protection they want in one forum shift to other fora to achieve their aims (Vivas-Eugui, 2003). This type of forum management is often referred to as 'forum shifting' or 'forum shopping'. As mentioned in Chapter 3, the shortcomings and paralysis of the World Intellectual Property Organization (WIPO), together with an active movement of industrial groups, led to the push to incorporate IP in the trade arena during the Uruguay Round in 1986, resulting in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) at the WTO, which came into force in 1995. When these countries and industrial groups were no longer able to get what they wanted at the WTO, they shifted back to certain treaties within WIPO (see Chapter 4) and started directly pressuring developing countries to raise their IP standards through bilateral and regional trade and investment agreements.

The number of bilateral and regional free trade agreements (FTAs) has increased dramatically, from 60 agreements in 1995 to almost 200 in early 2006 (WTO, 2006). In particular, the agreements being negotiated by the US and the EU with developing countries have raised serious concerns among civil society representatives, policymakers and developing country negotiators about a number of so-called 'TRIPS-plus' provisions in these agreements that go beyond countries' obligations under the TRIPS Agreement (Abbott, 2004). These provisions, they argue, will force ever more onerous IP systems on developing (and indeed developed) countries, thereby further limiting their space to implement systems that are supportive of their food security and livelihood objectives. A number of provisions are of particular relevance for agriculture (see also Table 7.1):

• Requirements to join Union Inernationale pour la Protection des Obtentions Végétales (UPOV): Many FTAs now include clauses that require the signatories to implement and/or accede to the UPOV Convention as the legal framework to protect plant breeders' rights. This requirement goes beyond the TRIPS Agreement, which allows Members to implement an 'effective sui generis system' of plant variety protection, deliberately leaving the nature of such protection undefined. UPOV 1991, in particular, has attracted strong criticism for the limitation it is thought to place on farmers' right to reuse and exchange seed and thereby ensure availability and diversity of seeds. The requirement to join UPOV 1991 has been introduced, for instance, in FTAs between the US and Lebanon, Morocco, Tunisia, Jordan, Central America (under CAFTA) and Peru, while US agreements with other countries, such as Ecuador and Mexico, require them 'to make every effort' to join UPOV 1991.
  
  
• Requirements to introduce patent protection for plants, animals and biotechnological inventions: Some FTAs, such as those of the US with Jordan, Mongolia, Nicaragua, Sri Lanka and Vietnam, have introduced an obligation to provide patent protection on plants and animals. The TRIPS Agreement, in contrast, explicitly allows for plant and animals to be excluded from patentability as long as patent protection is provided for micro-organisms and some form of IP protection is given to plant varieties. The EU–South Africa agreement requires patent protection for biological inventions, which presumably includes or could be interpreted as including plants and animals in addition to the protection for micro-organisms required by the TRIPS Agreement. Similarly, the scope of the Cotonou Agreement between the EU and the African, Caribbean and Pacific (ACP) countries includes patents for biotechnological inventions. The EU has also proposed TRIPS-plus standards of protection in the negotiation of economic partnership agreements (EPAs), notably the obligation to ratify or accede to UPOV 1991. The European Parliament, however, has called on the European Commission 'to ensure that intellectual property rights … are taken off the negotiating table if ACP countries do not wish to negotiate them.'²
  
  
• References to contracts: Most recently, the US has started to introduce language into FTAs, such as in the agreement reached with Peru and Colombia, recognizing that contracts can adequately address concerns about access to genetic resources or traditional knowledge and the benefit sharing arising from their use. While this provision is not a mandatory requirement, it introduces a concept advocated by the US in the WTO negotiations on the TRIPS–CBD relationship to counter proposals on disclosure requirements put forward by developing countries (see below). Since the US has signed but not ratified the CBD, it does not need to observe the Convention's provisions, the Bonn Guidelines on access to genetic resources and the fair and equitable sharing of the benefits arising from their utilization, or any future outcomes from the negotiations on a binding international regime on ABS (Chapter 5).
  
  
• Extension of patent protection period: Some FTAs have introduced longer patent protection beyond the minimum 20 years provided for in the TRIPS Agreement. For instance, in cases of unreasonable delays in granting a patent the US–Chile Agreement extends patent protection by five years from the date that the patent application was lodged or three years after a request for examination of the application has been made. Such extensions would further restrict access of researchers and farmers to patent-protected seeds (where patenting is allowed) and technologies.

In addition to the provisions in IP chapters of FTAs, these agreements include detailed provisions on investment which explicitly include IP rights (IPRs) as protected assets. The acquisition of IPRs over genetic materials obtained by a foreign company will give them, under investment agreements, the status of investor. Government acts affecting IPRs over such materials may raise complaints under applicable investment agreements (Correa, 2004b).

Enforcement

FTAs typically contain a dispute settlement chapter that governs disputes between the parties to the agreement. As the above discussion has made clear, the IP chapters of FTAs may in various ways limit choices that were available to states under TRIPS standards. These FTAs may also repeat obligations that the parties to the FTA have already agreed to in the context of TRIPS, meaning that these obligations can be enforced under the FTA between them. There are a large number of FTAs being signed and the dispute resolution chapters vary in their detail, but the following general observations can be made.

Those FTAs that allow for non-violation complaints (discussed below and in Box 3.2) to be brought in respect of the obligations agreed to in the IP chapters (for example the US–Australia FTA) set a dangerous precedent, especially for countries that are importers of patented technology and choose to regulate those patented technologies in some way. Non-violation complaints potentially open the door to arguments that a state's domestic regulation of patented products is inconsistent with its FTA obligations because it is robbing a group of patent owners of market benefits that they would have gained but for the regulation. Obviously this kind of logic, if accepted, could have a sweeping effect on regulation in areas such as pharmaceuticals, agricultural and food products. FTAs that permit non-violation complaints can in a sense be said to be TRIPS-plus since Article 64(2) of TRIPS introduced a five-year moratorium on non-violation complaints, a moratorium that was then extended.

Table 7.1 Selected North–South agreements with agriculture-related TRIPS-plus provisions

Sources: GRAIN, 2001; GRAIN 2005c; http://ec.europa.eu/comm./trade/issues/index_en.htm; www.ustr.gov

FTAs also constitute alternative fora for disputes over IP. Since so many FTAs are being signed, a global system of many trade courts is rapidly coming into being. The critical issue is whether this system will do much for trade, and in particular whether it will serve the trade interests of weaker players. Typically, developing countries gain little in an FTA on agriculture, but give away a lot on IP. By definition such players cannot resort to power politics to protect their rights under the trade regime. Whatever the criticisms of the WTO, its dispute settlement system is a comparatively transparent system that offers weaker players coalitional possibilities, but the same cannot be said of dispute settlement under an FTA. Given the intensity with which the US and EU have globally pursued their IP trade agenda, developing states may well come to rue the day when they helped to create bilateral enforcement rods for their own backs.

WTO accessions³

The TRIPS Agreement is one of the multilateral trade agreements to which all WTO Members are party. As an ordinary consequence of joining the WTO, a state or autonomous customs territory would be expected to become party to the TRIPS Agreement and take on the obligations applicable to other Members at their respective levels of development. However, the terms of the WTO Agreement do not expressly limit the 'entry fee' imposed on newly acceding Members to an equivalence of concessions with existing Members. As a consequence of this, accession negotiations have been used by certain Members as a mechanism for securing commitment to obligations in the field of IPRs that are more extensive than those established by the TRIPS Agreement (so-called 'TRIPS-plus' commitments) (Abbott and Correa, 2007).

In assessing the public policy implications of TRIPS-related provisions in accession agreements, the different legal mechanisms involved in the process are significant. In most cases, acceding countries do not make specific commitments on TRIPS-plus elements, although there are notable exceptions. However, the national legislation put in place during the accession process and reported or notified to the Members often contains TRIPS-plus elements beyond those identified in specific commitments. An acceding country is 'bound' only with respect to 'commitments' in the context of dispute settlement. However, an acceding country runs the risk of being the subject of a non-violation complaint brought on the basis of its Protocol of Accession, if such complaints are finally deemed applicable in the context of matters related to IP (Chapter 3, Box 3.2). Perhaps more important from a practical standpoint, the acceding country faces the prospect of diplomatic representations from economically important WTO Members about its failure to maintain the legislation adopted or announced during the accession process, even if technically the acceding country is free to change that legislation and to limit the level of protection to what is required by the TRIPS Agreement. The importance of economic diplomacy outside the specific context of WTO dispute settlement should not be discounted. That diplomacy may be combined with threats relating to suspension of trade preferences or economic aid packages.

TRIPS-plus provisions have even been required from least developed countries in the accession process. For example, Cambodia made a commitment to adhere to UPOV. This implies that plant varieties should be protected in Cambodia under breeders' rights in accordance with the 1991 Act of that Convention. Other countries have indicated that they have ratified or intend to ratify UPOV.

Harmonizing Genetic Resource Exchange with IP Protection

Controversies surrounding the role of IP and the misappropriation or 'biopiracy' of genetic resources and associated traditional knowledge (TK) have not only been at the heart of key issues negotiated in the various multilateral agreements discussed in Chapters 2–6, but also in setting the framework from which problems are being addressed. This section explores issues related to biopiracy and, in turn, how they have tended to shape responses to the problem and relationships between international instruments.

Biopiracy⁴

The vast majority of countries formally recognize that cross-border exchange of genetic resources and TK should be carried out in compliance with the principles of the Convention on Biological Diversity (CBD). IPRs, particularly patents but also plant variety protection, have become central to discussions on this matter for various reasons:

• the conviction – widely held among developing countries and NGOs – that biodiversity and associated traditional knowledge have tremendous economic potential;
  
  
• the fact that patent claims in various countries may incorporate biological and genetic material, including life forms, within their scope;
  
  
• the belief, also shared by developing countries and NGOs, that this feature of the patent system enables corporations to misappropriate genetic resources and associated TK or at least to unfairly free-ride on them;
  
  
• the ability of modern IP law to protect the innovations produced by industries based mainly in the developed world and its inability to protect adequately those in which the developing countries are relatively well-endowed; and
  
  
• the perception that, as a consequence of the above reasons, the unequal distribution and concentration of patent ownership and the unequal share of benefits obtained from industrial use of biogenetic resources are closely related.

Biopiracy has emerged as a term to describe the ways that corporations from the developed world free-ride on the genetic resources, TK and technologies of developing countries. While these and other corporations complain about 'intellectual piracy' perpetrated by people in developing countries, the latter group of nations counters that their biological, scientific and cultural assets are being 'pirated' by these same businesses. Intellectual piracy is a political term, which is inaccurate and deliberately so.

The assumption behind it is that the copying and selling of pharmaceuticals, music CDs and films anywhere in the world is wrong irrespective of whether the works in question had patent or copyright protection under domestic laws. After all, if drugs cannot be patented in a certain country, copying them by local companies for the domestic market and/or overseas markets where the drugs in question are also not patented is not piracy in the legal sense of the word.

Similarly, biopiracy is an imprecise term, and there are good reasons to keep it so, at least in the international arena. But such 'strategic vagueness' is not a helpful approach for those working on legal solutions in national laws, regulations or international conventions.

So what does biopiracy mean? It is a compound word consisting of 'bio', which is short for 'biological', and 'piracy'. According to the Concise Oxford Dictionary, 'piracy' means (1) the practice or an act of robbery of ships at sea; (2) a similar practice or act in other forms, especially hijacking; and (3) the infringement of copyright. Apart from the use of 'piracy' for rhetorical effect, the word does not seem to be applicable to the kinds of act referred to as biopiracy. But what about the verb 'to pirate'? The two definitions given are (1) appropriate or reproduce (the work or ideas etc of another) without permission for one's own benefit; and (2) plunder.

These definitions seem to be more appropriate since inherent to the biopiracy rhetoric are misappropriation and theft. In essence, 'biopirates' are those individuals and companies accused of one or both of the following acts: (1) the misappropriation of genetic resources and/or TK through the patent system and (2) the unauthorized collection for commercial ends of genetic resources and/or TK. Since biopiracy is not just a matter of law but also one of morality and of fairness, it is not always easy to draw the line between an act of biopiracy and a legitimate practice. This difficulty is compounded by the vagueness in the way the term is applied. To illustrate this point, a wide range of acts, listed below, have been considered as acts of biopiracy of TK:

Collection and use:

• the unauthorized use of common TK;
  
• the unauthorized use of TK only found among one indigenous group;
  
• the unauthorized use of TK acquired by deception or failure to fully disclosure the commercial motive behind the acquisition;
  
• the unauthorized use of TK acquired on the basis of a transaction deemed to be exploitative;
  
• the unauthorized use of TK acquired on the basis of a conviction that all such transactions are inherently exploitative ('all bioprospecting is biopiracy'); and
  
• the commercial use of TK on the basis of a literature search.

Patenting:

• the patent claims TK in the form in which it was acquired;
  
• the patent covers a refinement of the TK; and
  
• the patent covers an invention based on TK and other modern/traditional knowledge.

It is not clear how much biopiracy actually takes place. Apart from lack of information, the answer depends on how one differentiates between legitimate and unfair exploitation. The distinction is not always obvious. The answer also depends on whether resources are considered to be wild and unowned or domesticated and owned. A common view among critics of conventional business practice is that most companies do not recognize that they may have a moral obligation to compensate communities providing genetic material for their intellectual contribution even when such material is assumed to be 'wild'. Often genetic resources considered 'gifts of nature' in fact result from many generations of selective crop breeding and landscape management. Essentially the argument is that failing to recognize and compensate for the past and present intellectual contributions of traditional communities is a form of intellectual piracy.

The likely response from industry is that this is not piracy since the present generation may have done little to develop or conserve these resources. The argument might continue that this is, at worst, a policy failure, and that measures outside the IPR system could be put into place to ensure that traditional communities are rewarded.

As for the patent-related version of biopiracy, there is little doubt that companies are in an advantageous position in the sense that, while a useful characteristic of a plant or animal may be well known to a traditional community, without being able to describe the phenomenon in the language of chemistry or molecular biology, the community cannot obtain a patent even if it could afford to do so. While it is unlikely that a company could then obtain a patent simply by describing the mode of action or the active compound, it could claim a synthetic version of the compound or even a purified extract. In the absence of a contract or specific regulation, the company would have no requirement to compensate the communities concerned.

The aim of this discussion is not to deny the existence of biopiracy, but to show that the lack of clarity is becoming counterproductive. The problem with the biopiracy rhetoric and the strategic vagueness behind its usage is that without agreement on what it is, it cannot be measured. Neither is it possible to decide what should be done about it. One extreme view is that all bioprospecting is biopiracy. If so, the answer is to ban access outright. If biopiracy is merely an irritation, then such a ban need not be enforced too rigorously, since legal enforcement of higher-stakes areas of the law would have to take priority. If biopiracy causes demonstrable economic and/or cultural harm, the country should invest in enforcing the ban. On the other hand, if the problem is that provider countries or communities are unable to negotiate beneficial agreements, the answer may be to improve the provision of legal and technical assistance. If the problem is that the patent system legitimizes or encourages misappropriation, then we may need to improve the standards of examination, ban patents on life forms and natural, or even modified, compounds, or incorporate a disclosure of origin requirement. In short, how you define biopiracy goes a long way towards determining what you should do about it.

Bad patents affect negotiations

Developing countries' governments, negotiators and civil society groups argue that the IP system not only fails to provide sufficient safeguards to prevent biopiracy or misappropriation but also fails to prevent the issuing of 'bad patents', in other words where the invention does not fulfil basic patent requirements, for instance in cases where inventions are based on existing TK or make use of traditional plant varieties developed by farmers. The onus of identifying potentially erroneous patents and proving the existence of 'prior art' is placed on the challenger of a patent – a process that is costly, time-consuming and difficult, in particular in cases where the TK has been kept and transmitted orally rather than in writing. Moreover, overly broad patents threaten to restrict innovation by impeding access to and use of genetic material, including for use by farmers and public research for further breeding.

Controversies surrounding the role of IP and misappropriation have played a key role not only in shaping various multilateral agreements, but also in setting the framework from which problems are being addressed. In responding to biopiracy, the misappropriation of genetic resources and barriers that were placed on the free flow of genetic resources through the expansion of IP protection (such as plant breeders' rights and patents), much of the focus in the different international negotiations revolved around the sharing of benefits from IP on genetic resources and TK. This failed to address the issue of patents that were bad in the first place, or whether IP is appropriate for genetic resources and TK, or alternative systems that would encourage conservation and exchange at the same time. The focus on benefit sharing shaped the way the CBD was developed, in that 'so much of it deals with matters that are not directly related to conservation of biological diversity' (Dutfield, 2002) but concern access and benefit sharing instead. The main approach on how to deal with the 'ABS–IP relationship' by different multilateral agreements has been on how to harmonize them. It is this harmonization, or lack of it, that mainly shapes many of the linkages between the different agreements, usually as a relationship between IP and the regulation of access to and the sharing of benefits from the use of genetic resources.

For example, in 2002, the Conference of the Parties of the CBD adopted the first Strategic Plan for the Convention, with the target of significantly reducing the rate of biodiversity loss by 2010. To achieve this target, the CBD must coordinate and harmonize with other international instruments, such as the WTO TRIPS Agreement and the UN Food and Agriculture Organization's (FAO) International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA, or the Treaty) as well as the Law of the Sea Convention (CBD, Article 22). An exception is carved out in the CBD for when 'those rights and obligations would cause a serious damage or threat to biological diversity' (Article 22.1). This raises the grey area, in the case of international agreements such as TRIPS and the CBD with provisions and aims that may be in conflict, of which agreement would have priority.

Harmonization nexus: Shaping relationships between international instruments

TRIPS and the CBD

The relationship between the provisions of TRIPS and the CBD has given rise to different opinions, ranging from those who see them as perfectly compatible to those who see them as quite inconsistent. Developing countries contend that TRIPS does not require patent applicants whose inventions incorporate or use genetic material or associated knowledge to comply with the obligations under the CBD (as discussed above and in Chapter 5). Developing countries have repeatedly voiced concern about possible misappropriation of their genetic resources by developed country patent applicants.

Different views on the TRIPS–CBD relationship have been expressed at the WTO during the review of Article 27.3(b) of TRIPS. While a number of developed countries have found no inconsistencies between the two treaties, several developing countries have indicated the need to reconcile them, possibly by means of a revision of TRIPS. The built-in review of Article 27.3(b) (discussed in Chapter 3) has not yet generated consensus and is one of the outstanding negotiating issues of the Doha Development Round, including 'the relationship between the TRIPS Agreement and the Convention on Biological Diversity, the protection of traditional knowledge and folklore' (WTO Doha Ministerial Declaration, paragraph 19). Since the adoption of the WTO Doha Ministerial Declaration, the issue has been included in the agenda of the TRIPS Council.

To address these concerns, developing countries have proposed in the WTO to amend the TRIPS Agreement to require an applicant for a patent relating to biological materials or TK to provide, as a condition for obtaining the patent:

• disclosure of the source and country of origin of the biological resource and of the TK used in the invention;
  
• evidence of prior informed consent through approval by authorities under the relevant national regime; and
  
• evidence of fair and equitable benefit sharing under the relevant national regime.

The approach to enforce CBD obligations through the TRIPS patent system is opposed, however, by a number of developed countries that see no conflict between the TRIPS Agreement and the CBD. For example, in the view of the US the proposed disclosure requirement is not an appropriate solution, and Members should focus on remedies such as the use of organized databases, information material to patentability, and the use of post-grant opposition or re-examination systems as an alternative to litigation.⁵ Moreover, despite repeated requests by several WTO Members, the CBD does not have permanent observer status in the TRIPS Council.

UPOV and the CBD

The Council of UPOV has adopted a position on ABS 'in order to provide some guidance on UPOV's views on the "process, nature, scope, elements and modalities of an international regime on access to genetic resources and benefit sharing"' (UPOV, 2003, paragraph 5). This position is based on the principles of the 1991 UPOV Convention. As part of the position, UPOV expresses its opposition to mandatory disclosure of origin as a condition for obtaining plant variety protection as this would be contrary to the terms of the UPOV Convention (paragraph 8). Similarly, UPOV is opposed to any certification requirements that would be a mandatory precondition to obtaining plant variety protection (paragraph 10). Finally, UPOV is also opposed to any revenue­sharing mechanism that would 'impose an additional administrative burden on the authority entrusted with the grant of breeders' rights and an additional financial obligation on the breeder when varieties are used for further breeding' (paragraph 12). UPOV believes that such a mechanism would run counter to the breeders' exemption in the UPOV Convention (see Chapter 2).

CBD and the ITPGRFA

The ITPGRFA has very strong institutional and historical links with the CBD, as discussed in Chapters 5 and 6. The Treaty is largely based on the premise that bilateral, private sector and market forces approaches do not function well for agriculture, and since agriculture has always been based on continued access and exchange of materials, a more 'communal access' approach is needed. The CBD provides for 'national sovereignty', which is frequently interpreted to mean various forms of exclusive ownership and control (sometimes state, sometimes private, sometimes hybrid). The Treaty is also based on the concept of national sovereignty, but exercised in such a way as to maintain a relatively open system. While allowing for the possibility of private ownership (through IPRs) at the periphery of the commons it creates, the Treaty focuses on maximizing the public goods aspects of plant genetic resources for food and agriculture (PGRFA). Its multilateral system of access and benefit sharing (MLS) 'pools' these crucial plant genetic resources in a managed commons and makes them available under the Standard Material Transfer Agreement (SMTA) – a single legal instrument that cannot be altered for all movements of materials within the MLS. Because these genetic resources are pooled, there is no need for individual negotiations for ABS as found in the kinds of bilaterally oriented access laws that countries are putting in place as they implement the CBD. Under the Treaty, decisions are also expected to be made collectively and the benefits must be shared in a pooled, multilateral manner, under the direction of the Governing Body (which is composed of all countries that have ratified the Treaty).

Although the Treaty was negotiated to bring the earlier International Undertaking on PGRFA (IU) into harmony with the CBD, it is neither subsidiary nor subject to the CBD. However, mutual supportiveness, including joint work programmes between the CBD and the Treaty, is very high on the agenda in both processes, and the FAO has concluded a Memorandum of Cooperation with the CBD.

The CBD provisions of prior informed consent and mutually agreed terms are 'built into' the MLS: all members mutually agree 'up front' to the terms set out in the Treaty and the SMTA. Annex I crops – for the purposes set out in the Treaty – now fall under a commons regime of facilitated access, without the transaction costs associated with the CBD. However, the CBD remains in force for all non-Annex I crops (for example soya), acquired after the entry into force of the CBD.

One of the most controversial parts of the Treaty is Article 12.3(d), which states that 'recipients shall not claim any IP or other rights that limit the facilitated access to the plant genetic resources for food and agriculture, or their genetic parts and components, in the form received from the MLS'. Such an undertaking is also included in the SMTA adopted to regulate the facilitated access.

The issue here is that in some legal jurisdictions, it is possible to patent DNA sequences and chemical substances that have been isolated from plant material without any structural modification. Therefore a patent holder could restrict – subject to possible research exemptions – use of the protected sequence or compound by others, and even access if the patent covered the method of isolation. It is not clear, however, whether this isolated material is still considered to be 'in the form received' from the MLS and so whether the prohibition against IP rights as contained in Article 12.3(d) would apply (Moore and Tymowski, 2005). To some developed countries, allowing such patents is necessary to encourage innovation and disclosure of the 'invention'. But to many developing countries (and perhaps some developed countries too), they legitimize misappropriation of resources to which they have sovereign rights and are contrary to the spirit of an international agreement that emphasizes exchange rather than appropriation. For others it is a fundamental mistake to allow the patent system to be extended to living organisms or parts thereof.

Garforth and Frison (2007) point out that the existence of these two instruments and their differing rules creates the potential for a number of debatable grey areas where it is not clear which obligations apply. For example:

• Countries that have ratified both the CBD and the Treaty will apply the rules of the MLS to those seeking to access the PGRFA listed in Annex I to the Treaty and the rules of the CBD to all other genetic resources. Countries that have only ratified the CBD, however, have no obligation to make the Annex I PGRFA available under the MLS and so can continue to apply the CBD rules for those seeking access to these resources. Presumably, someone seeking access to a specific PGRFA under the MLS would try to go to a country that has ratified the Treaty in order to take advantage of the presumably more facilitative access mechanism of the MLS. It is possible, therefore, to have the same genetic resource subject to a different approach to ABS (multilateral versus bilateral) depending on the country in which it is located.
  
  
• The distinction between what constitutes the use of a PGRFA and what constitutes the use of a plant genetic resource for other purposes is not always clear. A good example would be the case of Golden Rice. Golden Rice is rice that has been genetically engineered to produce extra vitamin A in order combat vitamin A deficiencies in children, which can lead to blindness. Golden Rice was obviously intended to be grown and eaten so it can be considered as a use related to food and agriculture. It was also intended, however, to combat a health problem, which would not make it a PGRFA. Food, nutrition and health are aptly conceived as a continuum rather than as distinct categories, so it can be unclear where the application of CBD rules should end and where the Treaty rules should begin. Determining which system of ABS should apply may become more complicated as the fields of nutraceuticals and biofortification develop and more crops are engineered to deliver specific health benefits. A further complication arises if the plant genetic resources have been accessed through the MLS with the original intention of using them for food and agriculture. If the intention subsequently changes, must the researcher trace the country of origin of the genetic resources in order to negotiate ABS terms?
  
  
• A final grey area concerns PGRFA not listed in Annex I to the Treaty. The obligations under the Treaty apply to all PGRFA, but the MLS only applies to the PGRFA listed in Annex I. Which ABS rules are countries to apply to non-Annex I PGRFA? Should they apply the CBD model or unilaterally treat them like part of the MLS? The presumption would probably be that the CBD rules (or a national ABS system implementing the CBD) would apply, particularly given the desire of some countries to specifically keep some species out of the MLS (see Chapter 6). However, The Netherlands is setting an example by already opting to use the SMTA for non-Annex I crops. The Ouadadougou Declaration⁶ recommended that some form of the SMTA should be used for non-Annex I crops. Finally, it is quite possible that the Treaty's Governing Body will decide that the CGIAR Centres should use the SMTA for non-Annex I crops. This last precedent, if it comes to pass, would not be 'unilateral' but an expression by the global community that using the SMTA for non-Annex I crops – in other words extending the same terms and conditions for ABS as in the MLS – is the most appropriate way forward. It is realistic to hope that these are precedents that will be followed, as suggested in Chapter 6. If the Governing Body of the Treaty agrees to expand the list of Annex I crops and forages at some point in the future, however, this grey area could become all the more murky.

ITPGRFA and UPOV

Article 13(d) of the ITPGRFA requires that:

… a recipient who commercializes a product that is a plant genetic resource for food and agriculture and that incorporates material accessed from the Multilateral System, shall pay to [a financial mechanism to be established] an equitable share of the benefits arising from the commercialization of that product, except whenever such a product is available without restriction to others for further research and breeding, in which case the recipient who commercializes shall be encouraged to make such payment.

In effect, this means that a recipient that sells a PGRFA product incorporating material from the multilateral system must pay monetary benefits from commercialization under the following circumstances: either he/she owns a patent on the product and – as is normally the case – there is no exemption in the patent law of the relevant jurisdiction that would freely allow others to use it for further research and breeding, or if access to using the new PGRFA product for research or breeding is blocked through technological means and/or by restrictive contractual provisions.

However, PGRFA products protected under UPOV Convention-compliant laws (or more flexible sui generis models) which include research and breeding exemptions would not trigger the benefit sharing mechanism. This reflects the political nature of the balance that was struck during negotiations (see Chapter 6) – (i.e. what kind of protection would trigger mandatory benefit sharing and what would not; the dissatisfaction of companies that depend on patents) – and to a large degree the bargaining power (or savvy) of the players at that point in history. Definitions in international fora about where the public domain starts and stops will be a key point to watch in the future. For example, it is known that big industry wants to interject a five-year 'grace period' during which time the research exemption would not operate under UPOV. If they are successful, that would remove a great deal of the current flexibility available to researchers and breeders under UPOV. This issue of 'what's left in the public domain' or 'what room is left to construct a commons' is one of the key issues to watch in the future.

The ITPGRFA and TRIPS

The interaction between the Treaty and the TRIPS Agreement has not yet been discussed in detail in the Treaty's Governing Body, although it is fully recognized that a strong relationship exists, not least because of the likely impact of IPRs on the ability to easily access or freely exchange genetic resources for food and agriculture and related technologies. However, as noted, the issues arising here largely reflect the ongoing global debates on the relationship between genetic resources and IPRs.

Articles 12.3(f) and 13.2(b)(iii) of the Treaty acknowledge that access to genetic resources shall be consistent with the adequate and effective protection of IPRs and relevant international agreements. However, unlike the CBD, which sees the possibility of actively using IPRs to further its objectives, the Treaty is more wary of their effects on its own objectives – prohibiting their use in the case of materials from the MLS to the extent that they would prohibit access to the materials in the form received, tolerating them where they will not constitute obstacles to access, and layering on an obligation to share financial benefits when they do. If countries sign agreements that oblige them to do away with breeders and research exemptions, the financial benefit sharing clause of the Treaty will be triggered more frequently. That is the most immediate nexus between TRIPS and possible future UPOV amendments. Although the interactions may be somewhat different, it is expected that the IPRs–genetic resources nexus in the context of the Treaty will evolve along similar paths as in the CBD, with the highly polarized positions (loosely along North–South lines) manifesting themselves once more.

Harmonization Versus Differentiation: The Relationship between WIPO and Other Intergovernmental Organizations

This section briefly explores some general issues and concerns being raised about WIPO's activities in relation to other intergovernmental organizations and some of the current relationships between WIPO and TRIPS, the CBD, the FAO and UPOV.

WIPO's role and mandate

IP is not like health, education, food or agriculture. It is a form of business regulation not a fundamental aspect of human needs. As such it is a subordinate activity that should be modified, reviewed and restructured according to how it helps or hinders meeting human needs. … Deciding on the shape and structure of the [IP] regime, the detailed rules that shape it, the balance of interests to be met and the measures by which it is judged requires a far wider range of inputs than those from legal and technical groups that make up the IP community and which dominate the practice of WIPO. (Musungu, 2005, p23)

Given the cross-cutting impact of IP rules on international objectives, norms and policies, and the breadth of WIPO activities in relation to IP rules, WIPO is often considered, by default, a lead UN agency dealing with IP matters.

Moreover, the Convention establishing WIPO stated that the organization should, where appropriate, establish working relations and cooperate with other intergovernmental organizations – over 60 intergovernmental organizations have observer status in WIPO, including the FAO, the United Nations Educational, Scientific and Cultural Organization (UNESCO), the World Health Organization (WHO), UPOV and the WTO. For example, WIPO has signed a number of agreements or memoranda of understanding that establish specific topics or activities for cooperation. As the UN specialized agency on IP, WIPO also provides support on IP-related issues that surface in a range of discussions and processes.

Certainly, the establishment of agreements between WIPO and other agencies is an important means of cooperating and pooling resources. Nevertheless, WIPO's collaboration with other intergovernmental agencies has not always been viewed positively. Fundamental questions have been raised about whose interests WIPO has in mind when it approaches the IP-related issues of other agencies. These questions arise given that the nature and orientation of WIPO, as seen by many developing countries and civil society organizations, is to promote protection of IP and to extend its coverage, no matter what. WIPO has also been heavily criticized for ignoring crucial development-oriented elements of its mission statement (Chapter 4, Box 4.1).

A key concern being raised about WIPO's collaboration with other UN agencies is that, under the guise of making the UN system more effective and efficient, WIPO's influence could end up reducing individual UN agencies' capacity to take a robust approach to ensuring IPRs do not undermine the environmental, food, farming, health and educational concerns that the UN promotes. UN agencies dealing with agriculture, health and the environment need to understand where and how IP is useful and where it is not. For this, though, agencies such as the FAO and the CBD need to have their own legal and technical expertise so they can analyse IP from the point of view of their mandates and determine how IP affects those objectives and how it needs to be dealt with to achieve them. For example, the FAO should be able to make the case for changes in the IP regime as and when necessary in the interest of people's access to food, seeds or other genetic resources.

The relationship between WIPO and other international instruments

WIPO and the CBD

Despite developing country concerns – or perhaps because of them – WIPO contributions to the ABS discussions at the CBD have been technical documents that generally avoid supporting a particular outcome for IP-related issues. To date, two technical studies have been requested by the Conference of the Parties of the CBD and approved by the WIPO General Assembly. The first study (CBD, 2003) was presented in 2004 and addressed 'methods consistent with obligations in treaties administered by WIPO for requiring the disclosure within patent applications, as per the CBD request'. The study found there is a range of disclosure requirements that are consistent with the essential elements of patent law and key aspects of WIPO treaties. However, the request itself seemed to imply that an international regime under the CBD should adequately consider and support IP rules, rather than vice versa, as foreseen by the CBD.

The second study derived from an invitation by the Seventh Meeting of the CBD Conference of the Parties for WIPO 'to examine, and where appropriate address, taking into account the need to ensure that this work is supportive of and does not run counter to the objectives of the CBD, issues regarding the interrelation of access to genetic resources and disclosure requirements in intellectual property rights applications' (CBD, 2004). Owing to concerns about such WIPO input precluding adequate consideration of the role of disclosure requirements in the CBD negotiations for an international regime on ABS, developing countries and civil society organizations aimed to ensure the 2005 WIPO response to the CBD request was balanced and recognized the leading role of the CBD on biodiversity-related issues. For instance, developing countries and civil society organizations called for the inclusion of a disclaimer that explicitly framed the document as only a technical input to facilitate discussions. They also urged for the WIPO response to include a clearer recognition that, while WIPO as an institution has a significant role in terms of addressing these issues within its own IP rules, it is only able to provide peripheral input into the CBD process. A five-stage process, with the possibility for WIPO Member States and observers to provide comments, was established to prepare the response, which thus – and as requested by many developing countries – provides an overview of the different positions on these issues rather than taking a particular stance in terms of the way forward (CBD, 2006d).

There seems to be almost a schizophrenic relationship between WIPO and the CBD. On the one hand, it could be beneficial for these institutions, as well as others dealing with genetic and biological resources, to cooperate and for the different negotiators at each to be more aware and understanding of the pertinent issues at the other. There is obviously some willingness for collaboration, judging by the CBD invitations to WIPO. On the other hand, though, there is a fear that inviting WIPO into the CBD will result in inappropriate influence on CBD discussions, particularly given the strength of certain countries in WIPO, notably the US, which are not Parties to the CBD.

WIPO and the WTO

Although the focus seemed to switch to the WTO with the advent of the TRIPS Agreement, WIPO did not diminish in its importance with the introduction of IP into the multilateral trading system. As discussed in Chapter 3, the Preamble to the TRIPS Agreement recognizes a desire to establish a mutually supportive relationship with WIPO, and two WIPO-administered treaties were incorporated into the TRIPS Agreement. WIPO found an important niche in providing technical assistance to support the implementation of the new international standards of IP protection.

The 1995 agreement on cooperation between WIPO and the WTO aims to facilitate the implementation of the TRIPS Agreement and provides for cooperation in three areas:

1. the notification of, access to, and translation of national laws and regulations;
   
2. the implementation of procedures for the protection of national emblems; and
   
3. technical cooperation.

As part of this cooperation, two joint technical cooperation agreements have also been launched. For example, in 1998 WTO and WIPO joined forces to assist developing country WTO Members in meeting the January 2000 deadline for implementing the TRIPS Agreement. Other activities include a range of national and regional seminars and colloquia for teachers of IP from developing countries and countries with economies in transition. In all these activities, WIPO's technical assistance has been heavily criticized for not considering both the costs and benefits of IP protection (Chapter 4, Box 4.3). Developing countries have called for a more balanced approach to technical assistance, focusing not only on the need to comply with the protection of IPRs, but also on the importance of IP rules contributing to:

… the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations. (TRIPS Agreement, Article 7).

In addition, the role of WIPO vis-à-vis the WTO in IP discussions has also come up expressly in discussions on IP and biodiversity. As developing countries seek to introduce disclosure requirements into the TRIPS Agreement (see Chapter 3), one of the recurring arguments used by some developed countries is that priority on these issues should be given to the WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC) (see Chapter 4). Although the WIPO IGC has done useful work on IP and biodiversity issues, there is significant concern that, rather than aiming to addressing IP and biodiversity issues, the emphasis on the IGC is primarily aimed at sidelining the WTO, considered as fundamental by developing countries given the potential conflicts between the CBD and TRIPS discussed above.

WIPO and the FAO

In 2005, an agreement between the FAO and WIPO was discussed by the Committee on Constitutional and Legal Matters at the FAO. This first version of the text included a preamble framing the draft agreement under the general premise that access to food may be more important than the protection of IP per se (Tansey, 2007). In 2005, the FAO Conference, the supreme governing body of the FAO, approved the memorandum of understanding between the FAO and WIPO devoid of the preamble and forwarded it to WIPO. The FAO–WIPO agreement aims to 'establish a mutually supportive relationship' between the FAO and WIPO and to establish 'appropriate arrangements for cooperation between them' (FAO, 2005). Provisions of the agreement encourage exchange of information; joint activities such as studies, seminars and workshops; and technical assistance or cooperation. The text of the agreement also contains a list of issues in which the organizations' work may intersect, including farmers' rights and TK; agricultural biotechnology; genetic resources for food and agriculture; promotion of innovation and the effective capture of benefits from public investment in research; use of distinctive signs in the food and agriculture sector; and ethical issues in food and agriculture. All these issues are essential from a public policy and sustainable development perspective. Concerns thus quickly arose regarding the potentially negative impact of the often limited WIPO perspective informing the FAO mission and role on these issues.

In 2006, Brazil, supported by other countries, opposed the approval of the agreement by the WIPO General Assembly. Their reasons focused on the potential negative impact of WIPO, which would counsel the FAO on major IP issues and on the FAO mission and role. They also objected to the fact that, under the agreement, the WIPO Secretariat, through the director general, would be able to establish and carry out work programmes with no involvement of Member States. The approval of the agreement was thus suspended.

Nevertheless, WIPO has already been actively contributing to FAO activities and discussions, particularly in relation to the Treaty. Because some of the most important elements in the MLS of the Treaty are directly related to IP, WIPO has participated both formally and informally in their elaboration. For example, WIPO was invited to send a representative to provide technical advice to both the Expert Group and Contact Group on the terms of the SMTA, the terms for access to all genetic resources covered by Annex I to the Treaty. WIPO is also preparing a report assessing patent data relevant to availability and use of material from ex-situ collections under the auspices of the FAO and the Treaty, undertaken at the request of the Commission on Genetic Resources for Food and Agriculture (CGRFA)

WIPO and UPOV

UPOV is an organization wholly independent of WIPO. However, under a 1982 Agreement, UPOV headquarters are located within WIPO buildings and the UPOV Council is obliged to appoint the director general of WIPO as the secretary general of UPOV. In addition to such administrative collaboration and support, WIPO also works closely with UPOV on a variety of issues.

In its 2004 annual report, UPOV describes a range of cooperation activities with WIPO. For example, UPOV participated in a meeting organized by WIPO towards the implementation of the Cooperation Agreement between WIPO and the governments of the Caribbean countries and gave a lecture about plant breeders' rights and small and medium-sized enterprises at a special programme organized by WIPO and the World Association for Small and Medium-sized Enterprises.

For many developing countries and civil society organizations, these activities raise concerns about the pressure for developing countries to adopt the UPOV Convention despite broad recognition that its provisions are suited for industrialized agriculture, rather than the agricultural systems that prevail in the developing world. As a result, there are increasing calls for any participation of UPOV in WIPO technical assistance activities to be balanced with information about other sui generis options for implementing the WTO requirement to protect plant varieties. Nevertheless, even though the TRIPS Agreement makes no mention of UPOV, UPOV is often the sole expert advice provider in technical assistance activities on the implementation of plant variety protection, with a view to complying with the TRIPS Agreement.

Implications for Genetic Resources for Food and Agriculture

Part of the problem in all of the various negotiations is that different constituencies have been negotiating them – primarily trade officials at the WTO, patent lawyers at WIPO, environment ministries at the CBD and agricultural ministries at the FAO – often without much domestic coordination. As a result, the same issue is being dealt with differently depending on the negotiating context. It is IP and trade constituents, in particular, that are driving the agenda: defining the strategies, issues and solutions and thus creating all kinds of implications for the conservation and biodiversity of genetic resources crucial for food and agriculture.

Interdependence versus sovereign rights⁷

As discussed in Chapter 5, the CBD clarified the inapplicability of 'common heritage' for plant genetic resources, affirming 'state sovereignty' of natural resources. Article 15 of the CBD on access to genetic resources assigns to national governments the authority to determine such access, which is subject to the prior informed consent of the provider country and the fair and equitable sharing of benefits. Presumably, the expectation here is that the exercise of such authority will enable countries to capture more of the benefits from industrial use of their biogenetic resources, which in turn will encourage them to invest in conserving and sustainably utilizing biodiversity.

However, there are five reasons to question whether the bargaining position of individual developing countries in plant genetic resource transactions is all that strong:

1. They tend to lack the scientific and technological capacity to capture the benefits from agro-biodiversity themselves.
   
   
2. Apportioning the benefits fairly may be impossible or unfeasible. For example, new plant varieties are often the product of generations of breeding and cross-breeding, which in turn are the result of selection and breeding by farmers throughout the world and of the evolution of non-domesticated varieties. Depending on the crop, plant breeders commonly work with up to 60 or so different landraces originating from 20 to 30 different countries (Chapter 6).
   
   
3. Countries are interdependent and not even biodiversity-rich tropical developing countries are self-sufficient. Every country is ultimately dependent upon exotic (non-indigenous) genetic resources essential for food and agriculture in such forms as wild crop progenitors, semi-domesticated crop relatives, landraces and cultivated varieties (cultivars), and therefore benefits from free access to genetic resources collected previously in other countries. To give just one example, when Brazil started to breed soya beans, the country imported genetic resources from the US. Interestingly, the origin of the soy bean is not North America at all, but East Asia. Despite this interdependence, it is ironic that during the 1990s, the extent of plant genetic resource collecting activities was reduced due, in no small part apparently, to concerns by some countries about 'biopiracy'.
   
   
4. A great deal of crop genetic resources are stored in ex-situ collections, such as those at universities, botanic gardens and gene banks held at the various CGIAR Centres. It is to the professional plant breeder's advantage to acquire genetic material from these sources for three reasons: first, because the collections are extensive and freely accessible; second, because basic information on accessions (material acquired) is usually available; and third because, in many cases, CGIAR breeding programmes have already selected some of the material for its desirable characteristics (see also Box 6.1).
   
   
5. Temperate zone countries may lack the species richness of tropical countries, yet may still be well endowed in terms of crop genetic diversity. The concentration of the world's biodiversity richness in the tropical zone may not necessarily coincide with the geography of agro-biodiversity-richness, especially of the major food crops. Temperate developed countries that have cultivated certain crops for centuries may be well endowed in balanced genetic structures, genes and traits that are desirable for crop breeders, and developing countries often need to import crop genetic resources from these countries for this reason. Strong evidence suggests, then, that if a developing country establishes a strong regulatory regime for access to crop genetic resources, industrialized world crop breeders would be affected far less than breeders in the South that might wish to exchange genetic resources with countries sharing the same agro-climatic conditions.

Country of origin, source or legal provenance⁸

Fights between countries are likely to arise as they quarrel over which gene 'originated' where and which nation should rightfully capture any benefits arising from its use. (Safrin, 2004)

Disclosure of origin is used as a general term that refers to different proposals concerning the disclosure of information on genetic resources and/or TK in patent applications. Certificates of origin are proposed as one tool for implementing potential disclosure of origin requirements. In essence, the idea entails requiring a person (natural or legal) who is applying for a patent on a biological or genetic resource to include as part of the patent application a certificate from the relevant authority attesting that the resource and any associated TK have been obtained in full compliance with the law of the country of origin. The purpose of disclosure and certificates of origin is to try to prevent instances of biopiracy where biological and genetic resources are acquired and patented without the patentee complying with the ABS requirements of the country from which the resources were obtained. Others have suggested refinements to the certificates concept. These include creating certificates of source or certificates of legal provenance. These concepts would not necessarily require tracking back a genetic resource all the way to its country of origin (in other words where the resource is found in-situ) but just to the place where the patent applicant obtained it (for example gene bank or botanical garden) or illustrating that the resource was obtained from a provider entitled to grant access.

Given the wide geographical dissemination of PGRFA over the centuries, it is in many cases impossible to establish where certain traits of agricultural value have developed (Chapter 6). This is one of the reasons why the Treaty opted for the MLS, under which benefits are shared multilaterally and there is no tracking of the 'country of origin' for Annex I materials. This only applies when the plant genetic resources are used for food or feed; for other uses, such as the development of a medicinal product, countries supplying materials may enforce CBD rules.

The absence in the Treaty of the concept of 'country of origin' or similar concepts of 'source' or 'legal provenance' is crucial for the facilitated access to and exchange of PGRFA. It does not mean, however, that sovereign rights are ignored. It is in the exercise of such rights (as recognized in Article 10.2 of the Treaty) that the Contracting Parties agreed to establish a system delinked from the determination of the origin or source.

Within the Treaty, the MLS is considered to be the origin of any accessed material as it secures appropriate benefit sharing. Therefore, the debate over whether to create international requirements for disclosure or certificates of origin is not as relevant. However, it is an issue to be considered given the centrality of certificate/disclosure of origin discussions in the CBD, the WTO and WIPO.

The CBD convened a meeting of a Group of Technical Experts on certificates in January 2007. During the meeting, the experts recognized that PGRFA fall within the scope of the ITPGRFA and that duplications with the Treaty should be avoided (CBD, 2007). There has thus been recognition of the fact that the creation of a certificates system at the CBD must also involve consideration of the modalities of the Treaty. As discussed in Chapter 5, another outcome from the meeting was a potential shift in terminology. 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'. This avoids the debate over the different proposals for certificates of origin, source or legal provenance, at least as far as what to call it.

Farmers' rights

The Treaty does not define farmers' rights and leaves it up to national governments to give effect to these rights as they see fit (see Chapter 6). The last paragraph of Article 9, however, points out that 'Nothing in this Article shall be interpreted to limit any rights that farmers have to save, use, exchange and sell farm-saved seed/propagating material, subject to national law and as appropriate.' Since the 1991 UPOV Convention does not permit the sale of protected seed without the authorization of the right holder, parties to the FAO Treaty that are not also parties to the UPOV Convention are free to adopt PVP legislation that upholds farmers' rights to the full extent allowable under the Treaty, which includes sale of protected seed. Otherwise, they must limit farmers' rights.

New enclosures

Some resources benefit from being shared. … The more the resources are shared, the more they are preserved. Genetic resources are this type of good. In contrast to engendering a tragedy of the commons, where a common resource is used to depletion, the sharing of genetic material under an open system increases the global genetic pool, as it ensures the maintenance of genetic material in multiple locations. The open system that predated the expansion of IP rights and sovereign rights over genetic material accounts for the widespread distribution and preservation of crops and crop varieties away from their places of origin. The maintenance of genetic material in multiple countries and locations has benefited all. For example, under the open system, grape seedlings from France were brought to the US. Later a blight destroyed many French vineyards and the US sent grape seedlings back to France. (Safrin, 2004)

The shift from the concept of 'common heritage' to sovereign rights over genetic resources risks creating an anti-commons or new enclosure systems in raw genetic material (Safrin, 2004; see also Chapter 1). In response to biopiracy and other concerns discussed above, developing countries are asserting their sovereign ownership over genetic materials by passing laws that restrict access to genetic materials within their countries. Whether it is from restricting access to genetic resources via IPRs or laws that restrict access 'an anti-commons can occur when too many individuals or entities have rights of exclusion to a given resource' (Safrin, 2004). Given the interdependence of all countries on PGRFA (see Chapter 6), an anti-commons or new enclosure systems in genetic resources poses many problems for the conservation, breeding and improvement of genetic resources crucial for food security.

Some critics have decried the CBD as an 'absolute disaster' for scientists seeking access (IFCNR, 2003). They point out that the Convention does not distinguish among scientists 'bioprospecting' for new drugs and pharmaceuticals, scientists conducting academic research, and scientists collecting samples for agricultural research and plant breeding, although others point out that many national rules implementing the CBD do make this distinction. The core problem, it is argued, is that the Convention is very narrowly fixated on the retention of rights and royalties on indigenous genetic resources. Resource-rich but economically depressed developing countries are loath to 'give away' any biological material that might prove lucrative. That emphasis has all but dried up sample collecting for gene banks that could well be the last chance to prevent biological extinction, an unintended consequence that undermines the entire purpose of CBD. For example, Dr Ricardo Callejas, a professor at the University of Antioquia in Medellín, Colombia, specializes in the 2000 species in the black pepper family (Revkin, 2002). His discipline is taxonomy, and he expressed the concern that the CBD had made the effort of collection and surveying impossible. 'If you request a permit,' Dr Callejas said, 'you have to provide coordinates for all sites to be visited and have to have the approval from all the communities that live in those areas.' After 14 months he was still waiting for a permit for collecting in Choco, Columbia (Revkin, 2002).

In some cases, scientists have been detained and their collections destroyed. In the Brazilian Amazon in 1998, an American geographer studying the forest for hints of ancient cultivation methods was placed under house arrest by the federal police in Santarem, and his boat, equipment and samples were seized. The scientist, Joseph McCann, had all the appropriate permits and visas. His gear and the title to his old riverboat were eventually returned, but most of the collection of pressed plants rotted because the police had stored it outside. The plants were destined for a Brazilian herbarium, not a pharmaceutical laboratory.

Safrin (2004) also argues that pushing the boundaries of sovereignty to achieve remuneration for accessed genetic materials also risks 'infringing on the autonomy and interests of individuals and indigenous communities whose land or property contains the genetic material' when states use pressure or force.

Other Linkages

There are a whole range of other international goals and agreements that are related to the linkages between IP, biodiversity, TK and food; this section provides a brief guide to some of them.

Human rights, access to seeds and the right to food⁹

International rules on both trade, formerly through the General Agreement on Tariffs and Trade (GATT), and human rights were developed in the 1940s in response to the same set of circumstances following the Second World War (Harrison, 2007). Despite this, both evolved separately, leading to the risk of inconsistencies, difficulties and conflicts between human rights and trade law and policy (de Schutter, 2007). The introduction of minimum global IPRs standards into the trade arena, through the TRIPS Agreement (Chapter 3), drew the attention of human rights advocates to the possibility of clashes between trade and human rights policy.

International human rights law applies – in some degree at least – to all countries. However, the relationship between IPRs and human rights has been a controversial issue since the beginning. Some argue that IPRs are implicit in the right to the protection of the moral and material interests of authors and the right to property in the Universal Declaration of Human Rights (UDHR) and the International Covenant on Economic, Social and Cultural Rights (ICESCR). Others argue that IPRs 'cannot be equated with the fundamental and inalienable entitlements of the human person', that they 'lack the fundamental characteristics of human rights as [they] are … limited in time and can be bought, sold or revoked'(3D→THREE, 2006), and that the language used to describe IPRs should be changed to more accurately reflect what they are – 'intellectually-based monopoly privileges (IMPs) granted by society to a few to exclude the rest' (FEC, 2002).

Many human rights can be affected by the types of monopoly privileges that are granted by IPRs. The rights at stake include the right to health (and the related obligation to ensure access to affordable medicines), the right to education (and the related access to educational materials), the right to food, the right to an effective remedy and the rights of indigenous peoples. For reasons of brevity, only the right to food and the mechanisms available to assist in its implementation are discussed here.

The right to food

The right to food is enshrined in many international human rights instruments, including the UDHR, ICESCR and the Convention on the Rights of the Child (CRC). Moreover, it is also protected through regional instruments such as the San Salvador Protocol to the American Convention on Human Rights and the African Charter on the Rights and Welfare of the Child.

IPRs can adversely affect the right to food in many different ways. For example, patents and plant variety protection on seeds can prevent farmers from breeding, saving and reusing seeds to feed themselves and their communities. Furthermore, patents can increase the cost of seeds, thereby making them inaccessible for small farmers – as they need to be bought each year and often require additional inputs such as herbicides and pesticides. Moreover, patents on microbiological processes, plants and animals may be culturally unacceptable for communities and traditional societies that are based on principles of free exchange of knowledge and seeds.

IPRs can affect the right to food, not only in terms of limiting access to food itself, but because the right extends beyond nutrition to encompass the notion of 'adequacy and sustainability of food'.¹⁰ The UN Committee on Economic, Social and Cultural Rights (CESCR), which oversees implementation of the ICESCR in the 156 countries that have agreed to be bound by the Covenant, have provided the most authoritative and detailed analysis of the scope of the right to food. This specifies that in order for the right to food to be realized, every individual alone or in a community must have physical and economic access at all times to adequate food or a means for its procurement. This requires cultural and consumer acceptability, availability of food by feeding oneself directly from productive land, natural resources or a well-functioning distribution system, and economic and physical accessibility.

States have an obligation to take measures to respect, protect and fulfil the right to food and move expeditiously towards this goal. The obligation to respect requires the state not to impede access to adequate food. This could include refraining from adhering to IPRs or plant variety protection systems that reduce access to seeds. The obligation to protect requires the state to take measures to ensure that individuals or enterprises do not deprive people of their access to adequate food. This could involve prohibiting biotech companies from patenting micro-organisms, plants and animals that obstruct the right to food, such as terminator seeds (terminator technology, also called genetic use restriction technology; see Chapter 5, Box 5.5). Finally, the obligation to fulfil requires the state to strengthen people's access to resources, in order to ensure their means to a livelihood and food security. This could be fulfilled by passing sui generis plant variety protection in a manner that is consistent with sustainable development and human rights.

The Voluntary Guidelines to Support the Progressive Realization of the Right to Adequate Food in the Context of National Food Security were adopted at the FAO Council in 2004. The aim was to provide practical guidance to states on the implementation of the right to adequate food in the context of national food security and to achieve the goal of the World Food Summit. Without very strong political commitment to implementing the guidelines, however, it is debated whether the guidelines achieved 'a breakthrough in setting standards' of interpretation of the right to food developed in the human rights system of the UN (Windfuhr and Jonsén, 2005) or actually weakened it.

Human rights mechanisms

Human rights mechanisms can be used to hold states and private actors accountable for any adverse effects of IPRs on the right to food. Human rights treaty bodies have held states accountable for IPRs by recommending that governments systematically consider human rights norms when negotiating IPRs and implementing them into national law, in addition to undertaking impact assessments before negotiating such agreements.¹¹ Moreover, a number of mechanisms have stressed that corporate actors must respect the right to food. For example, the UN Commission on Human Rights in 2005 requested 'all states and private actors, as well as international organizations … to take fully into account the need to promote the effective realization of the right to food for all, including in the ongoing negotiations in different fields'.¹² Finally, the UN Special Rapporteur on the right to food has called on states to put greater emphasis on the responsibility of private actors and international organizations – such as the IMF, World Bank and WTO – in ensuring that their activities do not violate enjoyment of the right to food.¹³

TK

In a sense, international IP agreements like TRIPS are a form of 'globalized localism', in which European and North American norms concerning the regulation of knowledge have become universal. If TK were to be protected in the form of a widened applicability of the customary norms of the TK holders, it would be a manifestation of the same phenomenon. The problem is that while TRIPS was foisted on the world by big business and powerful governments, TK protection cannot depend on such support, meaning that a truly effective and culturally appropriate international regime is unlikely to be achieved. Moreover, TK tends to be discussed in fora like the WTO Council for TRIPS and WIPO. Important as the debates in these fora are, TK is inevitably treated narrowly in such places as an IP issue, and governments like to keep it that way. To treat TK in a more holistic fashion might require some serious reflection on national governance, including the possibility of providing legal pluralism and ceding power from central government to the regions. It is hardly surprising, then, that many governments are unwilling to broaden the discussion. Moreover, the motives of some developing country governments in pursuing a TK 'solution' appear to be based on questionable assumptions about the commercial potential of TK. TK is of value primarily to local people. The idea that local high-tech industries could use TK to discover lots of blockbuster drugs and help significantly to increase a country's gross national product and trade balance is probably illusory. Sooner or later governments will realize this. And when they do, there is a real concern that they will quietly drop the TK issue, especially if they are granted concessions on other IP or trade-related concerns in return for doing so.

Internationally, TK protection is a very fragmented issue. TK relating to biodiversity is covered by the CBD, WIPO and the WTO. TK and health is a WHO matter, except when the emphasis is on plant-related knowledge, in which case the former three institutions are relevant. The WHO is not involved in norm setting in this area, however. As for agricultural knowledge, the FAO also has an interest. UNESCO provides a forum for discussion of expressions of folklore and culture, along with WIPO. How much of the deliberations in these fora have affected international law? Perhaps not as much as they should. WIPO has drafted two sets of provisions for the protection of TK and of traditional cultural expressions (WIPO, 2006a and b). Potentially these could form the basis for international treaties, but only time will tell if they will. In 2003, UNESCO adopted its Convention for the Safeguarding of the Intangible Cultural Heritage. Important as this treaty may turn out to be, it is somewhat soft in the extent of its binding obligations on governments. The 2005 UNESCO Convention on the Protection and Promotion of the Diversity of Cultural Expressions reaffirms in Article 1 'the sovereign rights of states to maintain, adopt and implement policies and measures that they deem appropriate for the protection and promotion of the diversity of cultural expressions on their territory'. Unfortunately, one can envisage this top–down principle being used to legitimize paternalistic and ineffective policies that run counter to the wishes of those peoples possessing the cultural expressions to be protected and promoted.

One demand of developing countries that has cut across several of these fora (WIPO, the WTO and the CBD) is disclosure of origin (see above). As we have seen, the proposal is that countries amend their patent laws to require that inventions claiming or using genetic resources and associated TK disclose the source of such resources and knowledge in their patent applications, otherwise the patent may not be granted or may be revoked if already granted. While such a measure may provide some additional transparency in terms of international movements of genetic resources and TK, some are less certain that it will do much to prevent misappropriation of TK. Moreover, the US is completely opposed to the idea of amending its patent law to require disclosure of origin and is unlikely to shift its position.

Millennium Development Goals,
IPRs and food security

The Millennium Development Goals (MDGs) are non-binding international targets on reducing global poverty to be achieved by 2015. They are drawn from the actions and targets contained in the Millennium Declaration that was adopted by 189 nations and signed by 147 heads of state and governments during the UN Millennium Summit in September 2000. Of the eight goals, three goals are of particular interest to the intersection between IPRs and food security:

MDG 1: Eradicate extreme hunger and poverty

Indicators:

• Reduce by half the proportion of people living on less than a dollar a day.
  
  
• Reduce by half the proportion of people who suffer from hunger (incorporated from the 1996 World Food Summit at the FAO but changed from numbers to proportion of hungry people; see Chapter 1).

Countries' poverty reduction strategies may include supporting their small-scale farming sector to increase income levels, enhance food supply and reduce poverty. Farmers' free access to improved seeds and the right to reuse and exchange seeds can provide one of the tools towards this goal by ensuring sustained input into the farming sector. At the same time, investments in public research – unimpeded by onerous IP requirements – may be required to improve agricultural productivity and nutritional content for crops of particular interest to local farmers. In addition, incentives, including within the IP system, might need to be put in place to stimulate private sector innovation that addresses the needs of the poor.

MDG 7: Ensure environmental sustainability

Indicator:

• Integrate the principles of sustainable development into country policies and programmes; reverse loss of environmental resources.

Efforts to achieve this goal might require addressing concerns that the existing IP system and associated private monopoly privileges encourage a shift towards large-scale monoculture production that threatens to erode agricultural biodiversity while negatively impacting on environmental sustainability (through water pollution or habitat loss, for example). This goal is directly related to MDG 1, given that sustainable agricultural production – which is necessary to reduce hunger and poverty – relies on genetic seed diversity for future breeding and on the continued viability of the land.

MDG 8: Develop a global partnership for development

Indicators:

• Develop further an open trading and financial system that is rule-based, predictable and non-discriminatory and includes a commitment to good governance, development and poverty reduction – nationally and internationally.
  
  
• In cooperation with the private sector, make available the benefits of new technologies – especially information and communications technologies.

As an integral part of the MLS, the TRIPS Agreement might need to be rebalanced to provide sufficient flexibilities for countries to implement policies necessary to achieve their specific objectives under the MDGs and include provisions that actively support these objectives. In line with MDG 8, this would include access to relevant technologies necessary to meet development priorities, including in the agriculture sector.

Trade and development

UNCTAD

Food security is one important facet of the 'development dimension' of IPRs, which also includes issues such as poverty reduction, environmental protection, innovation, technology transfer and public health. As the main international body charged with examining trade issues from a development perspective, the UN Conference on Trade and Development (UNCTAD) undertakes policy analysis, technical assistance and consensus building activities designed to ensure that the development dimension of IPRs is fully addressed by both domestic policies and international action. UNCTAD has three main areas of work connected with IPRs and food security:

1. supporting the protection, preservation and promotion of the TK and genetic resources of developing countries;
   
   
2. promoting organic agriculture as a trade and sustainable development opportunity for developing countries; and
   
   
3. building the capacity of developing countries to analyse and negotiate trade-related IPRs.

UNCTAD's approach to TK and genetic resources focuses on providing in-depth analytical support to inform the debate on national and international measures related to TK and genetic resources. This research considers both IPR- and non-IPR-based policy options and deals with food security as one aspect of sustainable development. UNCTAD aims to develop policy options that respect the rights and interests of the holders of TK and that ensure that any exploitation of genetic resources is carried out according to principles of prior informed consent and fair and equitable benefit sharing. Recent research by UNCTAD has identified practical measures that developing countries can take at the national level to protect, preserve and promote TK, such as legal recognition of the customary practices and knowledge ownership of local communities and acting to preserve TK in living diverse communities through securing land rights and enhancing livelihoods. In response to a request by the CBD, UNCTAD has also provided a thorough analysis of policy options for implementing disclosure of origin requirements in IP applications (Sarnoff and Correa, 2006). Such measures could help to improve the IP system and aid food security goals by ensuring that developing countries have control over their knowledge and genetic resources and receive a fair share of any benefits derived from them.

One policy response to food security concerns is the promotion of organic agriculture. The results of UNCTAD's research and capacity-building activities in this area indicate that organic agriculture can deliver a number of trade and sustainable development opportunities for developing countries, including enhanced food security, improved public health, decreased pollution and increased incomes for smallholder farmers. These benefits provide a further rationale for protecting TK, as organic agriculture builds on a foundation of traditional agricultural practices, varieties and knowledge to adapt organic techniques to local conditions. Under the Capacity-Building Task Force on Trade and Environment, UNCTAD is working with the United Nations Environment Programme (UNEP) to identify and develop opportunities for organic agriculture in East Africa. UNCTAD is also working with the FAO and the International Federation of Organic Agriculture Movements in an International Task Force aimed at harmonizing the multiplicity of standards and regulations faced by organic exporters.

UNCTAD also collaborates with the International Centre for Trade and Sustainable Development (ICTSD) on the Capacity Building Project on IPRs and Sustainable Development. This aims to improve understanding of the development implications of the TRIPS Agreement and to strengthen the analytical and negotiating capacity of developing countries so that they are better able to participate in IPR-related negotiations. To this end, UNCTAD and ICTSD have published a Resource Book on TRIPS and Development and several research papers and organized a series of seminars and dialogues that brought together negotiators, experts in the field and representatives from intergovernmental organizations and NGOs to discuss IP-related policies and negotiations.

UNCTAD also pays particular attention to the needs of the least developed countries. It has recommended that they should not be subject to any arbitrary deadline for complying with TRIPS obligations and that neither should those undertaking WTO accession (discussed above) be subject to 'TRIPS-plus' requirements (UNCTAD, 2007). In general, it suggests IP regimes should be adapted to enable least developed countries improve their ability to produce and market competitive products, that TRIPS flexibilities should be enhanced and not eroded via bilateral agreements.

Finally, the UNCTAD BioTrade Initiative promotes trade and investment in biological resources in line with the objectives of the CBD. It works on legal and policy issues linked to IP, including the role of geographical indications in distinguishing BioTrade products. It also collaborates with Bioversity International (formerly the International Plant Genetic Resources Institute, or IPGRI) on these issues. UNCTAD BioTrade also heads a working group of biodiversity-related multilateral environmental agreements looking at issues such as trade, private sector engagement and incentive measures. The UNCTAD BioTrade Initiative is also developing guidelines for benefit sharing in BioTrade activities, including issues such as TK and IP.

UNCTAD's future work on this subject, as on others, will be decided by its member states. Therefore, if the relationship between IP and food security is recognized as an issue that is central to development efforts, further emphasis can be expected to be placed on the provision by UNCTAD of research, consensus building and technical assistance in this area.

Conclusion

As IPRs have expanded and the number of agreements has grown, so too has the level of complexity of problems – and the creation of new ones – as they intersect with an ever-widening range of issues. Chapter 8 will explore how more and more groups are becoming involved and responding to some of these issues in different ways.

Document(s) 11 of 20