5 A Proposal on International Audits to Track and Monitor Flows of Genetic Resources and Verify Compliance with ABS Agreements

Manuel Ruiz Muller and Isabel Lapeña1

Executive summary

Tracking and monitoring of genetic resources have only recently become issues of interest in the context of discussions regarding access to these resources and benefit sharing (ABS). This chapter suggests that these systems can be analyzed from two closely related perspectives. ※Tracking§ is part of the process of verifying how genetic resources and their derived products flow and move along the research and development chain (including collecting and product commercialization stages). It basically addresses the ※physical§ movement and use of these resources. ※Monitoring§ on the other hand, could be understood as verifying whether institutions are using genetic resources as originally stipulated in the corresponding access agreements (including Material Transfer Agreements (MTAs)) with the country of origin or provider.

This chapter looks at a few examples of tracking and monitoring for different purposes and highlights the recurrent concern over costs. It also refers briefly to the concept of certificates of origin/legal provenance and some of the key questions which should be posed in relation to their operation.

The central proposal put forward is the possibility of establishing an international audit system for tracking and monitoring international flows of genetic resources under the Convention on Biological Diversity (CBD) and the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA). This system would focus on evaluating compliance with access to genetic resources agreements (or MTAs given the case).

Clearly, reporting requirements, quite standard in all projects, are insufficient to guarantee that interests of countries of origin and providers are being appropriately met. An international audit system, which selects only a limited amount of projects worldwide and evaluates their performance in relation to the use being given to genetic resources (in accordance with the corresponding contract) could serve to either dissipate or confirm a series of concerns. This chapter argues that continuous and exhaustive tracking of resources and monitoring of contracts is costly, ineffective and extremely complex from a political point of view. More targeted tracking and monitoring (agreed by all Parties to the ITPGRFA and the CBD) may be a more realistic approach. Furthermore, these audits or valuations could be applied to a wide range and broad scope of projects 每 whether commercially or academically oriented.

Of all the different issues addressed by the Convention on Biological Diversity (CBD), access to genetic resources and benefit sharing (ABS) has probably been 每 and continues to be 每 the most contested and disputed. Control and rights over genetic resources and their derived products, have been and remain at the core of ABS-related policy, legal and economic discussions (Caillaux 1996).

To address the issue of control of and rights in genetic resources, more than a dozen ABS laws have been enacted and are currently in force in different countries and regions of the world, and a similar number of drafts are at some stage of development in many others.2 These laws and policies derive in turn from a new paradigm: regulated albeit facilitated access, vis 角 vis free access based on the common heritage of mankind principle (from the pre-CBD era).

International guidelines (Bonn Guidelines on Access to Genetic Resources and Benefit Sharing, 2002) and even a global binding agreement (FAO International Treaty on Plant Genetic Resources for Food and Agriculture, 2001), have also been developed to address and cover some aspects of ABS and a wide range of related issues. Sectoral guidelines and institutional policies of, for example, ex-situ centers (microbial collections, botanic gardens, etc.) are also part of this complex structure of ABS provisions worldwide. All of these legal instruments are part of the international policy and legal framework on ABS. The focus of these laws, draft laws, regulations, guidelines, and the ITPGRFA, as well as CBD Article 15 itself, is to regulate conditions under which genetic resources can be accessed from in-situ and ex-situ sources and, subsequently used for conservation and research in many areas, including for commercially intended research and development.

Without exception, a common feature among these laws and instruments is a bilateral approach to negotiating conditions on ABS. Contracts are the tool of choice to legally bind applicants and users with the country of origin (represented by a national competent authority) and/or the physical provider of genetic resources. These contracts generally include a series of obligations imposed on users of genetic resources as a means to safeguard the rights and interests of countries of origin and providers of genetic resources. In a way, this approach is a natural progression from and reaction to the pre-CBD open access/common heritage paradigm, and to the post-1992 explicit recognition of the sovereign right of countries to decide how and under what conditions their natural resources 每 including genetic resources 每 can be utilized (Glowka et al. 1994).

Until recently, however, the primary focus of work in this area has been on the questions of ※regulation§ without giving particular attention to the means of ensuring that the regulations have an impact on actual genetic resource development activities. Furthermore, over the past few years there has been growing consensus among countries (especially among the Group of Like-Minded Megadiverse Countries3) that, unless there is coordinated and concerted action taken by countries of origin (or countries and institutions providing genetic resources) and countries and institutions using genetic resources, the effectiveness of ABS laws and instruments and contracts in particular will be limited.4

As is frequently noted, it is impossible in practice to police and control physical access to genetic resources as may be the case for other natural resources such as minerals, oil or timber. Reasons for this are varied and include: size and amount of biological materials required to undertake research and development activities; existence of ex-situ facilities which hold important collections of genetic resources and in most cases claim property over accessions; very complex legal agreements and arrangements between researchers, universities, companies in developing and developed countries alike (many times confidential); among others. It is also extremely complicated for countries and institutions to track and monitor genetic resources throughout the in-situ collecting, research and development stages and the chain of value-adding process.

Tracking and monitoring can be understood as two closely related processes. ※Tracking§ refers to following the movement of genetic resources (and their derived products) along the research and development chain, while ※monitoring§ refers to verifying that the uses being given to these resources and products are reflected in and are permitted by the original ABS contracts (or subsequent contracts) and national laws under which research and development are undertaken. Tracking may imply identifying what institutions are actually doing research on collected genetic resources. Monitoring may imply verifying if research by these institutions is permitted in the light of obligations assumed in ABS contracts or whether research has taken a totally different route than originally planned 每 and whether this is provided for in the ABS contract.

Even if technically possible (for example through the use of DNA technology, fingerprinting and molecular markers or more common project result reports), tracking and monitoring require time, resources, equipment and human resources and skills which may not be currently available in most developing countries. Most importantly, there needs to be commitment by countries and institutions providing and using resources alike. And in terms of cost-benefit-analysis, it seems that at least in the case of certain types of resources (genetic resources used in plant breeding), regularly tracking and monitoring the flow of these, would not be worth the effort (Visser et al. 2000).

As mentioned above, tracking and monitoring are very closely related to and make sense in the context of conditions and obligations agreed upon in contracts. Contracts imply usually four phases: negotiations, celebration (signing), execution and enforcement. Of these phases, enforcing contractual obligations becomes the most critical challenge as we move upwards in the value-adding chain and as original materials get broken up and transformed into isolated genes, proteins, DNA segments, molecules, even synthetic or semi-synthetic products. What was originally agreed upon in a contract may not apply or be relevant to future situations and products generated from genetic resources. Countries of origin or providers would have a harder time in demonstrating they actually provided these elements. The jurisdiction of courts, as resources and their transformed versions pass between different countries and institutions, poses yet another complex challenge.

To help overcome this situation, and the only seemingly viable option under discussion 每 at this time anyhow 每 an international certification of origin and legal provenance regime is being advocated to prevent misappropriation of resources (and related traditional knowledge) and to assist in tracking and monitoring the flow of genetic resources (Correa 2005; Barber et al. 2003). These tools may help countries of origin and especially source countries actually providing genetic resources to ensure that their legal rights (including sovereignty) and economic interests in genetic resources which are moving and flowing outside national jurisdictions and removed from any real possibility of control, are effectively protected. But for this idea to develop and operate, countries using genetic resources need to adopt measures which include and recognize certificates as a requirement and condition to commercialize certain products or, in some cases, as a condition for the granting of intellectual property rights.5 User countries would also need to establish legal provisions which sanction third party illegal use of genetic resources as a means to support source country demands. The source country's interests would be additionally safeguarded if their right to demand benefit sharing and enforce this demand were addressed by the user country's legislation.

In very simple terms, source countries (countries physically providing genetic resources) are asking the following two questions: (i) how can genetic resources be tracked, traced and monitored along the value-adding chain in the research and development process? and (ii) how can countries verify compliance with originally agreed conditions and requirements in an ABS contract?6

5.1 Tracking and monitoring in the context of the CBD and the ITPGRFA

The CBD makes no explicit reference to tracking or monitoring the flows of genetic resources. It does, however, provide the legal foundations for developing the certification of origin and legal provenance concept and thus, indirectly, justifies the calls for tracking and monitoring by countries of origin, as a means to verify compliance with ABS agreements. This is based on the accepted international principle that countries have common but differentiated responsibilities7 with regard to the realization of the CBD objectives, one of which is benefit sharing. One way in which these differences become clear is when countries are identified as providers and as users of genetic resources.8

Article 15 (7) of the CBD establishes that each Contracting Party:

shall take legislative, administrative or policy measures, as appropriate, and in accordance with Articles 16 and 19 and, where necessary, through the financial mechanism established by articles 20 and 21 with the aim of sharing in a fair and equitable way the results of research and development and the benefits arising from the commercial and other utilization of genetic resources with the Contracting Party providing such resources [...].

Article 15 (7) refers to each Contracting Party taking measures to ensure benefits arising from the use of genetic resources are fairly and equitably shared. This means an obligation on countries of origin providing genetic resources and countries receiving and using them alike. All countries must contribute 每 in different ways and using different policy, administrative and legal tools 每 in order to realize the benefit-sharing objective of the CBD. It is under this framework and logic that the idea of a certificate of origin and legal provenance has been developed over the last few years.

How would a certificate of origin, source, or legal provenance operate? A country of origin or source country providing genetic resources would issue the certificate and a country accessing and/or using these resources would request that the certificate be presented and provided at certain moments during the value-adding chain, for example, during a product approval procedure or during intellectual property application processes.9 This would enable the ABS system to guarantee that legal formalities regarding access have been met. In some cases, it may also indicate that benefit sharing has taken place and in others, that it should take place through some sort of notification system.

Most proposals to date have centered on the use of certificates in the context of linking with intellectual property instruments. For example, in the Andean Community, prior to processing a patent application (especially in the case of biologically derived inventions), the national IP authority has the right to request that evidence is provided regarding the legal origin of biological resources or traditional knowledge which may have been used in the invention under consideration.10 Though the mechanism is in place, there is no reliable information as to how national IPR offices are implementing these provisions. This type of approach has been incorporated into several national policy processes and is under intensive discussion in the international arena in forums such as WIPO and WTO.

Even though the CBD does not specifically refer to tracking or monitoring of genetic resources per se, compliance with and enforcement of ABS contracts requires some type of mechanism which enables countries and institutions to exercise and enforce their rights. This will almost certainly require that these countries and institutions have precise information available regarding how their resources are being used and whether these uses coincide with contractual provisions originally stipulated. Tracking and monitoring could provide this type of information. Under the ITPGRFA on the other hand, and for very practical reasons, it was agreed that access should be facilitated expeditiously without the need to track individual accessions. However, there needs to be some practical way to verify what is being done with resources which have been accessed and are being used.

In the case of the ITPGRFA, which is based on a Multilateral System of [facilitated] Access and Benefit Sharing, unlike the CBD there is a specific reference to tracking. Article 12.3.b provides that access to plant genetic resources for food and agriculture (PGRFA), which are incorporated in a closed list, will be accorded expeditiously ※without the need to track individual accessions and free of charge ...§.11 This is an attempt to ensure the Multilateral System operates efficiently, with minimum burdens and low transaction costs associated with the movement and transfer of plant genetic resources of critical importance for food and agriculture (PGRFA).12 The rationale behind this provision is to ensure that PGRFA continue to flow unimpaired for conservation purposes, and research and development-related activities.

Under the Multilateral System, Material Transfer Agreements (MTA) 每 standard contracts 每 are used to link providers with immediate and subsequent users of PGRFA. What article 12.3.b seems to imply is that holders of PGRFA are not required to track and monitor the flows of each and every material which has been accessed from the system. Tracking and monitoring would only be relevant 每 and may be needed 每 if there is a breach in and/or non-compliance with the terms and conditions imposed by the MTA (Moore et al. 2005). However, given that the ITPGRFA applies only to materials in the public domain and under the control of the State, there are many ways in which users may obtain materials from individual farmers, from non-member countries and even ex-situ collections. This poses a serious question in terms of incentives to comply with ITPGRFA rules and use the MTA as an instrument to define access and flow conditions.

In any case, the underlying idea is that, given the importance of interdependence between countries in regard to PGRFA, verifying movements and flows of every single seed or genetic resource used for conservation, research and breeding could seriously jeopardize these activities and, ultimately, affect food security worldwide. This implies a critical trade-off between the exercise of strong controls over access and use of genetic resources and the need to look for and ensure food security worldwide.

5.1.1 Ensuring compliance of ABS rules and principles

Tracking the flows of genetic resources could also be seen as a means of assisting in building some ※teeth§ into the CBD operations and the ABS international regime in particular.

In this regard, in the specific context of the ITPGRFA, countries recognized the importance of developing compliance mechanisms within the IT as a means of fulfilling the obligations and conditions set out in the standard MTA. For this purpose, the Governing Body at its first meeting will consider mechanisms and instruments to promote compliance including through monitoring and offering advice and assistance, especially to developing countries.

This will require consideration of mechanisms through which compliance of obligations of MTAs can be verified. At a minimum, this will also probably include specific reporting requirements, information exchange mechanisms regarding results of research on PGRFA obtained from the Multilateral System (through a clearing house) or through some valuation or audit mechanism (see also Chapter 2 for some initial thoughts on this idea).

In the context of the CBD, and as part of the process of negotiating an international regime on ABS, there are good reasons to speculate that compliance (in this case with ABS contracts) will become a key feature in these negotiations, just as compliance is a key component in the implementation process of the ITPGRFA.

As a background to this, paragraph (p) of point 15 of The Hague Ministerial Declaration of the Conference of the Parties of the CBD, urged governments to ※undertake adequate measures with respect to their international obligations, including through the development of mechanisms for assessment and review of implementation and the establishment of compliance regimes.§ This will probably require a combination of measures including recognition of rights, definition of jurisdiction and pinpointing the location of genetic resources along the research and development process and its different contractually obliged actors.

Tracking and monitoring are not an end in themselves. They are a mechanism which could serve the specific purpose of ensuring countries of origin and providers legal interests in regard to the materials they supply, including interests related to the CBD objectives of benefit sharing.

5.2 Examples of tracking and monitoring: Alpacas, sharks and botanical research institutes

There are a few documented examples available of how countries and institutions are addressing tracking and monitoring, not so much in the area of following genetic resources per se, as in following the movements of certain plant and animal species (and derived materials). Technology, including microchips, the Geographical Positioning System, DNA markers, databases and the internet in general, are playing a very important role in enhancing the capacities of tracking and monitoring the movement and flows of endangered species. Having a detailed situational ※picture§ and a well founded, scientifically grounded, base line of data and information regarding the conservation and trade status of these species is critical in ensuring that sound policies and regulations are put into place and the appropriate control measures are imposed.

Peru is home to more than 90% of the world's alpaca (Lama pacos) population and a leading producer and exporter of alpaca wool (4000 tons per annum) 每 greatly appreciated in European, Japanese and North American fashion markets. Alpacas are also increasingly used as domestic pets in Europe and North America. Raising alpacas (vicuñas and llamas) provides the main income for small, poor rural communities living between 4,000 and 5,000 m above sea level in the Andes. Exportation of alpaca specimens is subject to strict controls and regulations in Peru 每 under the competence of the National Council for South American Camelids (CONACS).

To control and monitor the illegal movement and trade of alpacas across the borders with Chile and Bolivia, some of the best (genetically ※clean§) specimens are implanted with a microchip which, with the aid of the Geographical Positioning System, enables national authorities to track and monitor their movement, especially across the Peruvian border with neighboring countries, which have also become exporters of alpaca, mostly of Peruvian origin. These microchips also enable border custom officers to undertake regular interventions to impede illegal trade in this species. According to statistics by the Ministry of Agriculture of Peru, the country has lost since 1995 almost US$ 400 million from illegal exports (contraband) of alpaca and alpaca-derived products 每 mostly via Chile and Bolivia.13 The problem of illegal or very questionable exports of Andean camelids (including alpaca, llama and vicuñas) over the past few years is very complex. Specimens have been exported to the U.S., New Zealand and Australia and are now bred extensively in these countries. A recent issue is the use of camelid antibodies for pharmaceutical research and their commercial potential in this market.14

In another effort to monitor what is happening with specific species, the Guy Harvey Research Institute in Florida has developed cutting edge DNA-based forensic techniques and markers to identify the species level of shark carcasses, dried shark fins and other products obtained from shark fisheries. Over 100 million sharks (of all species) are killed annually, mostly for the purpose of using their fins and other parts for culinary purposes. These techniques are revolutionizing research in the international shark trade and, especially, are expected to assist authorities in identifying sharks (and shark products) protected under U.S. and CITES regulations. They are also helping in the re-evaluation of public policies and regulations related to the conservation and protection of shark species and sustainability of shark fisheries.15 These techniques are only available in the U.S., Australia and Europe and are, albeit very precise, quite costly.

According to information on the Institute's web page, forensic analysis based on these techniques have used by the National Oceanographic and Atmospheric Administration and U.S. prosecutors as a basis for bringing suits for major CITES violations. If upheld by U.S. courts, they could offer a major breakthrough in the recognition of specimens and heretofore unrecognizable parts of specimens, for purposes of determination of the legality of their transport and trade.16

In contrast with these very practical examples of how technology allows for tracking resources, botanical research institutions around the world have developed their own mechanisms and regular practices under which they access biological materials and, in some cases, transfer samples to other research institutions.

In the specific case of herbarium specimens, for example, Royal Botanic Gardens Kew has developed an institutional policy which stipulates that when acquiring plant material from in-situ sources, Kew will work with an in-country partner (usually through a Memorandum of Understanding) and obtain prior informed consent (PIC) and relevant permits from national authorities.17

Herbarium materials are accessioned and sometimes also loaned to other research institutions for scientific and non-commercial research only. During the period 2002每2003 Kew accessioned (i.e. formally incorporated into collections) almost 23,000 specimens. Incoming herbarium specimens are provided with labels which incorporate basic information (location, date, scientist, partners, species, etc.) which is then electronically databased. Format and content details of labels vary around the world. In the case of Kew, and most botanical institutions around the world, existing human and economic resources are insufficient to database all individual specimens entering the collections, whether these are herbarium or living collections.

Kew may loan herbarium specimens on standard written terms, and generally prohibits commercial uses and sampling of specimens. Most loans are based on reliability and good faith in scientific partners who will receive materials for research, rather than in post-oversight mechanisms such as tracking and monitoring of each loaned specimen once they leave Kew. Kew has repeatedly expressed its concerns that any additional requirement that may be imposed in order to access biological materials will add to the already costly and timely process required to obtain permits, authorizations and PIC from national authorities 每 which relates directly to the costs of creating a new certification of origin/legal provenance requirement.18

These examples are an indication of important technological advances which may help in the process of monitoring and tracking species and their products and also in identifying how they are being utilized. Nevertheless, it remains undecided how these technologies may be applied and become operational in the context of an ABS system. On one hand, there are differences in tracking specific specimens, quite apart from the problems of identifying their progeny and products later in a research and development process. Secondly, these technologies are extremely specialized and available in very few developed countries, mainly in the U.S., Europe and Japan. Availability of these could be a problem especially if they are covered by IPR or other proprietary rights.

5.3 Certificates of origin or legal provenance: A step in the right direction in the context of the international regime on ABS?

Over the past few years, certificates of origin and legal provenance have become the subject of considerable attention by policy makers and scientists alike. Many see these certificates as a means to alleviate the current burdens and restrictions imposed by most existing ABS laws in their effort to address and solve all of the problems related to accessing and using genetic resources: regulating access as such, controlling immediate and future use of genetic resources, impeding illegal transboundary (and interinstitutional) flows of resources, safeguarding the sovereign rights of countries of origin, especially when resources are obtained from in-situ sources, protecting traditional knowledge related to biodiversity in some cases, among others.

Given that certificates of origin and legal provenance place a considerable part of responsibilities on the actual users of genetic resources, this may act as an incentive to reduce the rigidity and control-type approach most of the aforementioned ABS laws currently have.

Some, though, see certificates of origin as additional burdens on an already over-regulated scenario (Dutfield 2005). Since the mid-1990s, scientists from around the world have expressed their concerns that excessively zealous ABS legislation may have a negative impact on research activities, especially when these are clearly oriented towards non-commercial objectives (UNU 2005; Grajal 1999; Hoagland 1997). Though there is a blurred line sometimes between commercial and non-commercial research, it is not always possible to identify the borderline in a way that will facilitate the latter.

However, the condition for a certification regime to be successful is to ensure that user countries accept this instrument and incorporate it into the discussions of the (an) international ABS regime currently taking place (Young 2005; Ruiz Muller 2004). Certificates would need to be recognized at the international level (maybe as part of the ABS international regime) to become binding on all countries, especially those which have traditionally been perceived as users and transformers of genetic resources.

Though conceptually very appealing, even at this time there is still considerable uncertainty with regard to the practical operation and implications that certificates may have (see Chapter 1, above).

It is fairly easy to imagine a certificate traveling attached (and even pinned) to a specimen, with some basic data on this specimen. Herbarium specimens (and parts thereof) usually travel and flow this way (with labels attached).19 This is standard practice for institutional trading among botanical gardens, but may not continue where the specimens are acquired by commercial users. Even in the case of microbial culture collections, for transfers of materials, these are packed and shipped with a series of documents including shipping documents and invoice and safety information. It is much less clear how the certificate would apply to the movement of a single gene, a gene sequence, a molecule, a specific protein, etc. which is also part of a specific specimen. At the time of actual collecting (or physical access), limited, if any, information may be available regarding these specific component parts. Or the certificate of origin and legal provenance may refer to the specimen itself or a sample, individual seed or accession in some cases and not include any details regarding genetic resources per se.

Whatever the situation, some of the fundamental questions a certification regime would need to address include:

Each of these questions implies the need to assess a series of institutional, technological (scientific data, information and tools) and human resource capacities in order to ensure that a certification of origin and legal provenance mechanism becomes operational. This includes evaluating the incentives for different actors to accept a certification scheme (see Chapter 4 above).

5.4. An international audit system for tracking and monitoring the flow and legal use of genetic resources

A major concern for countries which are Contracting Parties to the CBD and the ITPGRFA is whether and how to develop and make operational a mechanism which assists in verifying whether the ABS conditions agreed upon (※mutually agreed terms§ in ABS contracts, including the standard (and special) terms in Material Transfer Agreements 每 MTA) are being met and complied with. Tracking and monitoring proposals become an almost natural response to assist in this effort. Voluntary and even obligatory reporting requirements in typical research projects do not seem to generate the appropriate incentive to inform on what exactly is being done with materials.

This needs to be assessed in a context where tracking every transfer and subsequent movement of every single material or resource covered by the CBD or the ITPGRFA throughout the world is a daunting task even if the technology, human and financial resources are available.20

Although MTAs (and ABS contracts under the CBD) impose legal obligations on parties which sign them, effective compliance with their terms (and, ultimately, possibilities for oversight and enforcement) is still limited not only by jurisdictional issues (what courts and plaintiffs would have competence in specific cases), but also due to the physical and informational nature of genetic resources and the dynamics of technologies which make use of them at different stages of the research and development process. This is particularly true in the case of genetic resources which are, in essence, coded information.21

To claim a breach in MTA or contract obligations in general, providing countries (or in some cases countries of origin or other institutions) require information regarding:

with conditions set in these contractual instruments. Indeed, in any contractual relationship, a considerable level of good faith (bona fides) is required. However, mechanisms must also be in place to ensure an appropriate level of oversight and verification as to how parties (especially recipients and users of materials in this case) are behaving contractually and abiding by their obligations.

The biopiracy22 phenomenon and recent documented cases of it (e.g. patents on ayahuasca, quinoa, maca, beans, etc.) have contributed to generating an understandable situation where countries of origin are requesting additional assurances that materials which are part of the Multilateral System of facilitated access under the ITPGRFA and all materials covered by the CBD, will be utilized strictly in accordance and conformity with binding MTAs and ABS conditions and obligations set in contracts.

Although MTAs and contracts offer a first legal filter to ensure the correct and legitimate use of materials, how these are subsequently used (maybe in a transformed version i.e., as a derived product) especially in cases where resources flow to third countries, remains an explicit worry of countries which have traditionally been sources and the origin of them.23 The issue of ※derived products§ or ※derivatives§ is a controversial one within CBD debates. Some see derivatives as too detached from the original genetic resources on which they may have been based. Others argue that, whatever the distance, these (derived) products ultimately exist because of the mere existence of the original genetic resources on which they where based 每 no matter the level of technology and innovation which may have been applied.

Genetic resources are in essence a ※packet of informational goods§ which are presented as biological material (biological tissue, a seed, a leaf, skin, an entire specimen, etc.) which, include molecules, gene sequences, DNA, RNA, proteins, enzymes, etc. Each of these elements may have a specific function and potential use and, in some cases, may be subject to specific legal rules, including intellectual property rights. Technologies nowadays enable the use of the packet as a whole or in isolation and even use of its component elements thereof (individually or in combination).24 If semi-synthetic or synthetic products are added to this list of elements, there is yet a third set of elements which may also be subject to intellectual property regimes.

From a legal perspective, this poses a problem as rules may apply to the actual ※packet§ as a whole or its individual components separately. In some countries, for example, the legal status of the ※packet§ (i.e., biological materials) may differ from the legal status assigned to its components (i.e., genetic resources, genes, DNA).25

One pressing question and challenge is how to develop a cost-effective mechanism to allow for tracking and monitoring, especially of genetic resources (and derived products), which is practical and does not affect normal flows of resources on one hand, but is effective in verifying that these are being appropriately used, according to MTA and contractual obligations and satisfies the interests of providing countries, institutions and, especially, countries of origin.

An a priori assumption behind these ideas is that reports which are regularly required or expected in research and development projects, are not sufficient to guarantee an appropriate level of assurances regarding how resources are being utilized.

Given these circumstances, one suggestion may be the establishment of a small task force composed of expert representatives of countries with the mandate to undertake an annual international valuation or audit process which follows genetic resources which are under the Multilateral System and ABS contracts or agreements under the CBD from their sources (where they were accessed) to any phase in the research and development process. For example, this may include tracking and monitoring the movement and use of a resource obtained from an ex-situ centre, all the way to its incorporation into a cosmetic or pharmaceutical products or even its use in a breeding program.

This may mean a random selection of a few projects based on a set of criteria and appropriate methodologies (maybe tailored to a case-by-case analysis). These may include projects or activities which imply access to Annex I materials and the celebration of MTAs and another set of projects which are based on collecting and using genetic materials of plant, animal and microbial origin for commercial and non-commercial purposes (in non-commercial areas of research). In the case of materials under the Multilateral System, maybe focus on transfers of materials made by International Agricultural Research Centers (IARC).

This task force would have the responsibility of carrying out an exhaustive and detailed assessment of a) how genetic resources move from in-situ or ex-situ sources (countries of origin or providing countries if it be the case) and b) whether contractual conditions and obligations agreed upon in MTAs or ABS contracts related to these resources, are being complied with as part of these specific projects. Possibly target six or seven sample projects (or more if there is an available and sufficient budget).

These assessments would require the consent of involved parties to the actual contracts, especially in the case of recipients.26 This type of assessment has the potential of determining how smoothly the system is operating but could face limitations in verifying overall compliance by the different actors involved. Indeed, these valuations or audits would be operating on a sample of agreements and MTAs.

Reports by the task force could maintain the confidentiality of certain information if so required by parties. Most important, it would conclude whether or not parties (and institutions) are complying with agreed MTA standards and ABS obligations set in contracts and whether resources are being used as originally agreed. The task force could provide a detailed flow chart of the movement of resources, their eventual transformation into a derived product, their incorporation into a commercially viable product, etc. and their movement along the value-adding chain.

At each stage of this process, the task force would evaluate to what extent MTAs and ABS contracts are useful or not in a priori covering a range of options for (and uses of) genetic resources. The task force would also come to a preliminary (non-judicial and non-binding) determination as to whether contractual terms are being met.

In terms of a step-by-step process, the task force could report to the Governing Body or COP on each evaluated project and identify problems, gaps, shortcomings and potential measures to overcome these. All of these would relate strictly to MTAs and ABS obligations in contracts. The Governing Body and COP could then negotiate and decide on the type of measures they would like to adopt at the policy level for countries to consider as a means to support compliance and enforcement measures in general.

From a political perspective, countries of origin and parties to the ITPGRFA and the CBD in general, would have a mechanism available to address 每 to some degree 每 a valid concern of countries, that is, whether flows of materials are responding to the ITPGRFA and CBD principles and obligations, and MTA and contract conditions.

If undertaken with transparency and openness (i.e., making public results of these valuations or audits) the process would also serve to ascertain whether or not MTAs and the Multilateral System and the CBD ABS provisions (and contracts used in most, if not all, ABS laws and regulations in place worldwide) are operating as envisioned and what are the main difficulties.

From a legal point of view, this would be advancing in the effective implementation of the ITPGRFA and CBD, without individual tracking of specific resources. From a technical and economic perspective, these audits would not entail huge budgets and complicated bureaucracies and have a positive impact in terms of providing the ITPGRFA and CBD with useful information regarding where gaps and problems may be arising in actual practice.

This mechanism is not designed to assist each and every country to track and monitor and verify compliance with ABS conditions. But it may help in identifying good practices, good partners and how these country providers may develop more specific measures to satisfy their interests with regard to how their resources are being utilized.

5.5 Final comments

In debates regarding ABS it is surprising how little attention is paid to a key element embedded somewhere in human nature: good faith (bona fide). Whether it is discussing a national law or in international negotiations (in the CBD, WIPO, WTO or FAO processes), parties and actors involved either directly or indirectly in ABS processes seem to work their positions on the assumption that everything is suspicious and everybody is acting in their own self interest. There may be some solid arguments accumulated over the years to support this attitude. However, there needs to be a reassessment of the role of all actors and an honest and transparent approach to ABS discussions comprising (a) good faith in the negotiation of an ABS international regime; (b) in the negotiation of ABS contracts; (c) in complying with CBD principles and national laws; (d) in evaluating the pros and cons of tracking and monitoring options, including the certificate of origin and legal provenance idea. This is very practical realism. No oversight, compliance or enforcement mechanism, as perfect as it may be conceived, can replace good faith and positive incentives.

As difficult as it may be, however, differences should be made regarding basic, non-commercial research and research which is oriented towards the development of commercial products. Clearly, at the outset of projects, it is sometimes very difficult to envision future circumstances and how scientific research may be more inclined towards applied uses of genetic resources. It is at this moment where good faith should enter into play and concerned actors recognize the need to change conditions originally agreed upon in ABS contracts and negotiate these new conditions with countries of origin or providers of resources. New technologies and new disciplines such as bioinformatics, proteomics and genomics are certainly powerful research tools but which make development of appropriate policies and laws ever more complex. Informational goods 每 directly derived from digital libraries and specific databases 每 are the ultimate extension in the research on biodiversity and their utilization does pose an important challenge in terms of defining policies (or not) which link them to their original, essential source: biological and genetic resources.

An international audit or valuation system or mechanism, which annually and randomly evaluates how a few specific ABS projects (concrete projects which are using genetic resources and subjecting them to research and development) may help a wide range of actors understand better what type of policy and legal tools may be more appropriate to, in the right circumstance, justify tracking and monitoring efforts. Audits should apply to all ABS projects whether they are considered basic research or are commercially oriented. These audits should also extend to activities of ex-situ conservation centers.

References

Barber, C., B. Tobin and S. Johnston. 2003. User Measures. Options for Developing Measures in User Countries to Implement Access and Benefit-sharing Provisions of the Convention on Biological Diversity. UNU/IAS Report. Tokyo. [link]

Caillaux, J. 1996. ※Los derechos de propiedad intelectual, sus relaciones con la diversidad biol車gica y la protecci車n de los derechos de los pa赤ses amaz車nicos, especialmente de comunidades ind赤genas y locales sobre sus conocimientos, innovaciones y pr芍cticas,§ a paper presented in the Regional Workshop on the Protection of Knowledge and Technology regarding Amazonian Biodiversity. Iquitos: Secretar赤a Pro Tempore del Tratado de Cooperaci車n Amaz車nica.

Carrizosa, S., S. Brush, B. Wright and P. McGuire (eds). 2004. Accessing Biodiversity and Sharing the Benefits: Lessons from Implementing the Convention on Biological Diversity. Bonn: IUCN Environmental Policy and Law Paper No. 54, in collaboration with BMZ, Germany and GRCP, University of California, Davis. [link]

Correa, C. 2005. Alcances Jur赤dicos de las Exigencias de Divulgaci車n de Origen en el Sistema de Patentes y Derechos de Obtentor. Investigative Report. Lima: Iniciativa para la Prevenci車n de la Biopirater赤a. Sociedad Peruana de Derecho Ambiental. Año I, No. 2, Agosto 2005.

Decision VI/24, Annex. Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of Benefits Arising out of their Utilization.

Dutfield, G. 2005. ※Thinking Aloud on Disclosure of Origin.§ QUNO Occasional Paper 18.[link]

FAO International Treaty on Plant Genetic Resources for Food and Agriculture. [link]

Glowka, L., F. Burhenne-Guilmin and H. Synge. 1994. A Guide to the Convention on Biological Diversity. Gland and Cambridge: IUCN. Environmental Policy and Law Paper No. 30 [link]

Grajal, A. 1999. ※R谷gimen de Acceso a los Recursos Gen谷ticos Impone Restricciones a la Investigaci車n en Biodiversidad en los Pa赤ses Andinos.§ INTERCIENCIA 24(1): 63每69. [link]

Hoagland, E. 1997. ※Access to Specimens and their Genetic Resources: A Systematics Association Position Paper.§ For further information see http.//www.systass.org

Moore, G. and W. Tymowski. 2005. Explanatory Guide to the International Treaty on Plant Genetic Resources for Food and Agriculture. Bonn: IUCN Environmental Policy and Law Paper No. 57.[link]

Oldham, P. 2004. ※Global Status and Trends in Intellectual Property Claims: Genomics, Proteomics and Biotechnology,§ submission to the Executive Secretariat of the Convention on Biological Diversity. Also available as UNEP/CBD/WG-ABS/3/INF/4 as a submission by the European Community to the third meeting of the Ad Hoc Open-Ended Working Group on Access and Benefit Sharing, United Nations Convention on Biological Diversity, Bangkok, Thailand, 14每18 February 2005.[link]

Ruiz, M. 2004. An Assessment of the Advantages and Disadvantages of an International Regime for Access to Genetic Resources and Benefit Sharing. Policy and Environmental Law Series. Lima: Sociedad Peruana de Derecho Ambiental, No. 16.

UNEP/CBD/WG-ABS/3/INF/5. 2005. ※The feasibility, practicality and cost of a certificate of origin system for genetic resources: preliminary results of a comparative analysis of tracking material in biological resources centres of proposals for a certification scheme,§ paper submitted by the United Nations University. [link]

Visser, B., D. Eaton, N. Louwars and J. Engels. 2000. ※Transaction costs of germplasm exchange under bilateral agreements,§ document GFAR/00/17-04-04 prepared for the Secretariat of the Global Forum on Agricultural Research and presented at the GFAR meeting in Dresden, Germany, in May 2000. Available as: Background Study Paper No. 14 from the Commission on Genetic Resources for Food and Agriculture, Rome. [link]

Young, T. 2005. Options and Process for the Development of an International Regime on Access and Benefit Sharing. Summary Handbook for CBD Delegations. The ABS Project. Bonn: IUCN Environmental Law Centre.


1 Isabel Lapeña is a Senior Researcher at the Peruvian Society for Environmental Law (SPDA).

2 Countries with ABS legislation in place include Bolivia, Brazil, Colombia, Costa Rica, Ecuador, India, Peru, Philippines, Nepal and Venezuela. The Organization of African Unity (formed by 53 African States) also has a model law on ABS in place. Drafts have been developed and are at different levels of political discussion in Argentina, Chile, Madagascar, Malaysia, Mexico and Nicaragua, among others. For further details see: Carrizosa et al. 2004.

3 The Group of Like Minded Megadiverse Countries was formed in February 2002 in Canc迆n, Mexico. The Group at present comprises: Brazil, Bolivia, China, Colombia, Costa Rica, Ecuador, India, Indonesia, Kenya, Malaysia, Mexico, Peru, Philippines, South Africa and Venezuela. Its members hold almost 75% of the world's biodiversity in situ. The Canc迆n Declaration recognized the need for the ※creation of an international regime to effectively promote and safeguard the fair and equitable sharing of benefits arising from the use of biodiversity and its components.§ The Canc迆n Declaration became the first formal call by countries in this regard.

4 For a detailed analysis of this position see Barber et al. 2003.

5 Some critics argue that certificates of origin or legal provenance will, ultimately, not serve the purpose of preventing misappropriation of genetic resources and traditional knowledge (see Dutfield 2005). However, it should be noted that certificates are not the solution but a solution to the problem of misappropriation. They are part of a package of measures oriented at supporting tracking, monitoring, compliance and enforcement efforts.

6 Though policy makers and most analysts refer to ※countries of origin,§ its use is problematic in the context of ABS if one takes into account a potentially common situation where there is an ABS Agreement in place and countries of origin who have the species but are not the source for the actual user start demanding rights and attacking a user who has a valid contract or agreement with a single source country. This paper will not address the even more complex issue of genetic information and its probable source, which may be a country which is not even a country of origin nor a source country of the physical material.

7 The Preamble of the CBD (see, for example, paragraphs 15, 16 and 17) provides a set of basic principles in which explicit differences are made between developed and developing countries (including particular reference to small island states). All countries share similar responsibilities in conserving biodiversity but not all have similar capacities to conserve biodiversity and sustainably use its components.

8 All countries are providers and users of genetic resources at the same time. However, some have historically been more providers or users than others. The North-South paradigm which influenced debates during the 70s and 80s responds to this feature of biodiversity-poor but technologically rich countries from those which are biodiversity-rich but with less technological capacities.

9 Most debates regarding certificates of origin and legal provenance have taken place around the issue of modifying disclosure requirements in intellectual property (especially patent) legislation. See IUCN. 2005. The Complex Road towards Hong Kong: Proposals and Ideas to Move Forward in the CBD-TRIPS Relation Debates. Gland: IUCN.

10 See Decision 486 of the Andean Community on a Common Regime on Industrial Property. Articles 3, 26(h), (i), 75(g)(h). Available at: http.//www.comunidadandina.org. For a conceptual analysis of this idea, see Correa 2005. Available at: http.//www.biopirateria.org

11 During informal talks with some delegates and experts at ITPGRFA related meetings, they have expressed the view that this provision does not imply that source country cannot request some type of tracking to take place.

12 For further details on the issue of transaction costs with regard to PGRFA, see Visser et al. 2000.

13 For further information on this tracking and monitoring project see http.//www.peru.tk/modules/news/article.php/storyid=1389

14 See Pastor, S. and B. Fuentealba. 2005. Cam谷lidos, Nuevos Avances Tecnol車gicos y Patentes: Posibilidades y Preocupaciones para la Regi車n Andina. Documento de Investigaci車n. Lima: Iniciativa para la Prevenci車n de la Biopirater赤a. Año II, No. 4, Enero 2005.

15 See www.sciencenews.org/articles/20022012

16 See www.nova.edu/ocean/ghri/sharkforensics.html

17 See http.//www.rbgkew.org.uk

18 See UNEP/CBD/WG-ABS/3/INF/5. 2005.

19 See for example the situation of INBIO and its specimen collections in Costa Rica in UNEP/CBD/WG-ABS/3/INF/5, 2005.

20 Royal Botanic Gardens Kew undertook an assessment of what it would take to implement/comply with a certification of origin mechanism (which they determined would mean databasing all collections). Kew concluded that if the average 53,000 transactions a year in herbarium specimens are subject to complete databasing of accession, loans and transfers, a minimum of 3.5 new staff posts (assuming that each person could deal with a maximum of 69 accessions in a business day (seven minutes per accession)) would be required, which would be a very unlikely possibility even for Kew, one of, if not the most scientifically solid and financially stable institutions in the world.

21 See, Report from the Regional Biopiracy Prevention Workshop held in Bogot芍, Colombia, September 1每2, 2005. Available at: http.//www.biopirateria.org

22 ※Biopiracy§ is not a recent phenomenon. However, it has only in the last couple of decades gained widespread recognition and been given attention from a policy and legal (even economic) perspective and been widely reported upon by institutions and the media. Biopiracy may be defined as the illegal, unlawful, unethical, unjust and even immoral use of genetic resources and traditional knowledge, particularly in cases where products which directly or indirectly make use of resources or knowledge, become patented or protected through intellectual property instruments. This definition of biopiracy is provided by Law 28216 of Peru, which creates a National Commission for the Prevention of Biopiracy (2004).

23 The Group of Like-Minded Megadiverse Countries has been particularly vocal in expressing this concern. The Cusco Declaration of the Group (2002) reflects this concern. The report of the Open-Ended Ad Hoc Working Group on ABS (UNEP/CBD/COP/7/6 每 2003) also makes explicit reference to the need to develop and assess compliance and enforcement mechanisms (in legal regimes and contracts).

24 Some of the most powerful scientific disciplines today, including bioinformatics, genomics and proteomics, are gradually making (genetic) information the most valuable good in research and development processes. Informational products 每 in a wide range of sectors, including medical research, agroindustry, bioremediation, to name a few 每 are placing new challenges on the process of developing ABS policies and laws. For further details, see Oldham 2004.

25 In the Andean region, for example, Article 6 of Decision 391 (on a Common Regime on Access to Genetic Resources 每 in force in Bolivia, Colombia, Ecuador, Peru and Bolivia since July 1996) establishes that genetic resources are the property of the State or patrimony of the Nation, independently of the rights vested in biological materials which may contain these resources.

26 If a recipient was not to accept this audit process, this may serve as an indication of whether or not parties to the MTA (and the ITPGRFA and the CBD) are acting in good faith and with transparency, though not necessarily disqualifying the user/recipient for any wrongdoing.

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