The Question of Derivatives: Promoting use and ensuring availability of non-proprietary plant genetic resources Issues in Genetic Resources No. 12 September 2004 Ab stract Cary Fowler, Jan Engels and Emile Frison (compilers) The interface between plant genetic resources that are in the public domain and intellectual property rights regimes is a dynamic one, characterized by tension and even controversy. It has been this way for many years. Society’s interests lie in encouraging innovation with and use of plant genetic resources. In this respect the balance between the need to keep access to genetic resources unfettered so that anyone can use them and the need to allow innovators to claim certain property rights over their creations as a means of encouraging and rewarding such work is critically important. The centrepiece of this publication is an article - reprinted with permission from the Journal of World Intellectual Property - that focuses on the question “how much or how little must be done to germplasm accessed from the public domain before a grant of intellectual property rights can be sought”. The article examines the practices of centres of the Consultative Group on International Agricultural Research (CGIAR) and seeks to help the reader work through and evaluate a range of different options for how rules regarding derivatives might be handled in the future. In addition, this publication brings together a number of key related documents: the agreements between the CGIAR centres and the Food and Agriculture Organization of the United Nations (FAO) placing plant germplasm held by the centres under the auspices of the FAO; the joint statements issued by FAO and the CGIAR concerning these agreements; the two Material Transfer Agreements (MTAs) that the CGIAR centres have used; and the rel- evant sections of the International Treaty on Plant Genetic Resources for Food and Agriculture that will provide the legal context and framework for future rule systems dealing with the interface between germplasm and intellectual property rights regimes. While this publication focuses on the management of the CGIAR-held collections, we are aware that the issues discussed herein are and will remain of critical importance to the im- plementation of the International Treaty and the achievement of its goals. Comments and queries on the contents of this paper are welcome and should be ad dressed to: Volume Editor: J. Engels () Genetic Resources Science and Technology (GRST) IPGRI, Via dei Tre Denari, 472/a, 00057 Maccarese, Rome, Italy THE QUESTION OF DERIVATIVES: PROMOTING USE AND ENSURING AVAILABILITY OF PGR INTERNATIONAL PLANT GENETIC RESOURCES INSTITUTE 2 Issues in Genetic Resources is an occasional series of papers published by IPGRI on important topics of interest to the genetic resources community. You may download any Issues paper as a portable document format (PDF) fi le from http://www. ipgri.cgiar.org/publications. Hard copies can be obtained from IPGRI’s publications distribution offi ce (ipgri-publications@cgiar.org). The International Plant Genetic Resources Institute (IPGRI) is an independent international scientifi c organization that seeks to advance the conservation and use of plant genetic diversity for the well-being of present and future generations. It is one of 15 Future Harvest Centres supported by the Consultative Group on International Agricultural Research (CGIAR), an association of public and private members who support efforts to mobilize cutting-edge science to reduce hunger and poverty, improve human nutrition and health, and protect the environment. IPGRI has its headquarters in Maccarese, near Rome, Italy, with offi ces in more than 20 other countries worldwide. The Institute operates through three programmes: (1) the Plant Genetic Resources Programme, (2) the CGIAR Genetic Resources Support Programme and (3) the International Network for the Improvement of Banana and Plantain (INIBAP). The international status of IPGRI is conferred under an Establishment Agreement which, by January 2003, had been signed by the Governments of Algeria, Australia, Belgium, Benin, Bolivia, Brazil, Burkina Faso, Cameroon, Chile, China, Congo, Costa Rica, Côte d’Ivoire, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Greece, Guinea, Hungary, India, Indonesia, Iran, Israel, Italy, Jordan, Kenya, Malaysia, Mauritania, Morocco, Norway, Pakistan, Panama, Peru, Poland, Portugal, Romania, Russia, Senegal, Slovakia, Sudan, Switzerland, Syria, Tunisia, Turkey, Uganda and Ukraine. Financial support for IPGRI’s research is provided by more than 150 donors, including governments , pr ivate foundat ions and international organizations. For details of donors and research activities please see IPGRI’s Annual Reports, which are available in printed form on request from ipgri-publications@cgiar.org or from IPGRI’s Web site (www.ipgri.cgiar.org). The geographical designations employed and the presentation of material in this publication do not imply the expression of any opinion whatsoever on the part of IPGRI or the CGIAR concerning the legal status of any country, territory, city or area or its authorities, or concerning the delimitation of its frontiers or boundaries. Similarly, the views expressed are those of the authors and do not necessarily refl ect the views of these organizations. Mention of a proprietary name does not constitute endorsement of the product and is given only for information. Citation: Fowler, C., Engels, J. and Frison, E. 2004. The Question of Derivatives: Promoting use and ensuring availability of non-proprietary plant genetic resources. Issues in Genetic Resources No. XII, September 2004. International Plant Genetic Resources Institute, Rome, Italy. ISBN 92-9043-643-3 IPGRI Via dei Tre Denari, 472/a 00057 Maccarese Rome, Italy © International Plant Genetic Resources Institute, 2004 ISSUES IN GENETIC RESOURCES NO. 12 C. FOWLER, J. ENGELS AND E. FRISON (COMPILERS) 3 Foreword Emile Frison 5 The Question of Derivatives: Promoting Use and Ensuring Availability of Non-Proprietary Plant Genetic Resources Cary Fowler, Geoffrey Hawtin, Rodomiro Ortiz, Masa Iwanaga, and Jan Engels 7 Annexe 1: The Agreement Between [name of Centre] and the Food and Agriculture Organization of the United Nations (FAO) Placing Collections of Plant Germplasm under the Auspices of FAO 27 Annexe 2: Relevant parts of the International Treaty on Plant Genetic Resources for Food And Agriculture 29 Annexe 3: Material Transfer Agreement (MTA) (1998) 41 Annexe 4: Material Transfer Agreement for Plant Genetic Resources Held in Trust by the [Centre] (2003) 43 Annexe 5: [First] Joint Statement of FAO and the CGIAR Centres on the Agreement Placing CGIAR Germplasm Collections under the Auspices of FAO (1994) 45 Annexe 6: Second Joint Statement of FAO and the CGIAR Centres on the Agreement Placing CGIAR Germplasm Collections under the Auspices of FAO (1998) 47 Author affi liation and contacts 51 Contents THE QUESTION OF DERIVATIVES: PROMOTING USE AND ENSURING AVAILABILITY OF PGR INTERNATIONAL PLANT GENETIC RESOURCES INSTITUTE 4 ISSUES IN GENETIC RESOURCES NO. 12 C. FOWLER, J. ENGELS AND E. FRISON (COMPILERS) 5 This publication brings together under one roof, a number of documents pertaining to the interface between plant genetic resources that are in the public domain, and intellectual prop- erty rights regimes. The relationship between the two is a dynamic one, characterized by some degree of tension and even controversy. It has been this way for many years. Society’s interests certainly lie in encourag- ing innovation with and use of plant genetic resources. The trick lies in balancing the need to keep access to genetic resources unfettered so that anyone can use them with the need to allow innovators to claim certain property rights over their creations as a means of en- couraging and rewarding such work. Centres of the Consultative Group on International Agricultural Research (CGIAR) hold vast col- lections of plant genetic resources ‘in trust’ for the international community. Under agree- ments with the Food and Agriculture Organi- zation of the United Nations (FAO), samples are distributed under the terms of a Material Transfer Agreement (MTA) that enjoins re- cipients from claiming intellectual property rights over the material received. However, technologies for manipulating and employing genetic resources have been developing rap- idly. The question of how much or how little must be done to germplasm accessed from the public domain before intellectual property rights can be granted is ultimately a question about how to balance interests. At the same time it is also technically a complex matter. The centrepiece of this publication is an article that focuses on this question – the question of derivatives – that was published in the Journal of World Intellectual Property. We are grateful to the publishers of this journal for granting permission for us to use the text in its entirety in this publication. The article examines the practices of centres of the CGIAR, and seeks to help the reader work through and evaluate a range of different options for how rules regarding derivatives might be handled in the future. In addition to the article, this publication brings together a number of key related documents: the FAO- CGIAR agreements placing plant germplasm held by the centres under the auspices of the FAO; the joint statements issued by FAO and the CGIAR concerning these agreements; the two MTAs that the CGIAR Centres have used in recent years; and the relevant sections of the International Treaty on Plant Genetic Resources for Food and Agriculture, which will provide the legal context and framework for future rule systems dealing with the in- terface between germplasm included within the Treaty’s Multilateral System (including that held by the CGIAR centres) and intel- lectual property rights regimes. While this publication is aimed primarily at those interested in the management of the CGIAR-held collections, we are aware that the issues discussed herein are of critical impor- tance to the implementation of the Interna- tional Treaty, particularly at this moment when the Treaty’s Governing Body is preparing to negotiate the terms of their standard Material Transfer Agreement. Inevitably, any institution or body that seeks to accommodate both pub- lic (or multilateral) and private systems of ownership of plant genetic resources must set the borders and defi ne the relationships be- tween the two in ways that are clear enough so that those accessing germplasm can be certain of what is allowed and what is not while using the resource in research and breed- ing. Such defi nitions must also be clear enough to facilitate enforcement of the rules. With this publication, those interested and involved in ongoing discussions of this topic will fi nd a convenient resource that draws together both critical analyses and basic background documents. The aim of this pub- lication is not to provide defi nitive answers, but to encourage and facilitate research and discussion. Emile Frison Director General International Plant Genetic Resources Institute September 2004 Foreword THE QUESTION OF DERIVATIVES: PROMOTING USE AND ENSURING AVAILABILITY OF PGR INTERNATIONAL PLANT GENETIC RESOURCES INSTITUTE 6 ISSUES IN GENETIC RESOURCES NO. 12 C. FOWLER, J. ENGELS AND E. FRISON (COMPILERS) 7 Introduction How much, or in what ways, must one culti- var or crop breeding line vary from another in order to be considered different and distinct? Conversely, under which conditions might one be so similar—even if not exactly the same—as to be judged essentially as being the same as the other? Such questions are not just for philosophers. In a world in which owner- ship and control of crop varieties can defi ne the limits of the availability of germplasm for use in breeding programmes, as well as the potential for profi ts for commercial varieties, the question of derivatives becomes critical to the agricultural community in general and to plant breeders, legal experts and policy-mak- ers in particular. The “question” of derivatives has no single answer. This is probably as it should be, for the question arises in different circumstances and it is quite possible that a defi nition ap- propriate for intellectual property right (IPR) laws concerning new varieties would not be ideal for describing how much needs to be done to “public” germplasm before a claim can be made for a new invention. This article takes as its point of departure the management of plant genetic resources that are publicly available today from the Centres supported by the Consultative Group on International Agricultural Research (CGIAR) under Agreements with the Food and Agriculture Organization of the United Nations (FAO). These Agreements [see Annexe 1, now in their tenth year, are ex- pected to be of limited future duration, for the International Treaty on Plant Genetic Resources for Food and Agriculture [see Annexe 2 for selected parts of the Treaty] provides the legal framework now that it has entered into force.1 In the meantime, a con- sideration of the current FAO-CGIAR Agree- ments is warranted because they still constitute the framework within which thou- sands of materials are distributed annually; they provide a useful structure within which to consider the question of derivatives, not from the vantage point of an IPR regime, but from the perspective of the distribution and use of “public materials” and the attendant concerns of maintaining availability for use; and they are part of the history associated with the new Treaty—how countries have related to them says something about their intentions and about how certain provisions in the Treaty should be understood. A more detailed look at the question of derivatives, primarily placed within the context of the FAO-CGIAR Agreements, is thus of continu- ing interest and value. The question of derivatives in the context of the Agreements, or of the Treaty, is one that ultimately comes to focus on how to promote and encourage research and the use of plant genetic resources for food and agriculture that are publicly held. Many believe that IPR systems provide useful incentives in this re- gard. On the other hand, if genetic materials become “locked up”, research and use might be inhibited. How then, can public institu- tions distribute germplasm, encourage its use and ensure that those same resources remain available for access and use by the next per- son? This is the question ultimately addressed in this article. The discussion of the FAO- CGIAR Agreements is useful in its own right The Question of Derivatives: Promoting Use and Ensuring Availability of Non-Proprietary Plant Genetic Resources Cary Fowler,* Geoffrey Hawtin,† Rodomiro Ortiz,‡ Masa Iwanaga,§ and Jan Engels¶ *Center for International Environment and Development Studies (Noragric), Agricultural University of Norway, Aas, Norway, †Global Crop Diversity Trust, Rome, Italy, ‡International Institute of Tropical Agriculture (IITA), Ibadan, Nigeria, §International Maize and Wheat Improvement Center (CIMMYT), El Batan, Mexico and ¶IPGRI, Rome, Italy. This paper was fi rst published in The Journal of World Intellectual Property, 7 J.W.I.P. 5, September 2004, 641-663. IPGRI is grateful to Jacques Werner, Editor the journal and to Werner Publishing Company Ltd. for permission to reproduce the text here. 1 For background on the Treaty, full text and a list of signatories and ratifi cations, see the FAO Website at: ‹www.fao.org/ag/cgrfa/itpgr.htm›. The Treaty entered into force on 29 June 2004. THE QUESTION OF DERIVATIVES: PROMOTING USE AND ENSURING AVAILABILITY OF PGR INTERNATIONAL PLANT GENETIC RESOURCES INSTITUTE 8 but also serves as a surrogate for considering the complexities that the public sector faces in the management of plant genetic resourc- es for food and agriculture. The article does not address what may be a different set of concerns and goals associ- ated with the question of derivatives in the context of IPR law, in particular those related to the Union for the Protection of New Variet- ies of Plants (UPOV). It is not intended as a comment upon or critique of how such mat- ters are dealt with under this or other IPR legal regimes. In 1994, the Centres of the CGIAR placed collections of plant genetic resources “in trust” under the auspices of the FAO. In identical written Agreements [Annexe 1] signed separately with the FAO, the Cen- tres pledged to manage and administer the “accessions”2 in accordance with internation- ally accepted standards (including long-term storage), not to claim ownership or IPRs over the materials and to make the materials freely available to other users, provided that those recipients agreed to certain terms (i.e. not to claim ownership or seek IPRs). In discharging their responsibilities under the FAO Agreement, the CGIAR Centres dis- tribute covered materials under the terms of a Material Transfer Agreement (MTA) [Annexe 3], the wording of which they developed in conjunction with the FAO and the FAO Com- mission on Genetic Resources for Food and Agriculture. Through the original version of the MTA, a recipient “agree[d] not to claim ownership over the germplasm to be received, nor to seek IPRs over that germplasm or re- lated information.” The language of the MTA has recently been changed [Annexe 4]at the request of the FAO Commission on Genetic Resources for Food and Agriculture. The new language enjoins recipients from seeking IPRs “over that material, or its genetic parts or components, in the form received”. The re- cipient is also not allowed “to seek IPRs over related information received”. The language in both versions, original and current, gives rise to questions about the meaning of “germplasm” and about what recipients can and cannot do with the materi- als they receive vis-à-vis their incorporation into varieties for which IPRs might be sought. The issues and concerns raised in this article are not specifi c to either version of the MTA used by Centres of the CGIAR. Indeed, the Governing Body of the new Treaty, when it meets to negotiate and agree upon the word- ing of the standard MTA to be used by the Treaty’s Contracting Parties (countries) as well as by CGIAR Centres, will almost in- evitably face the issue of how to deal with derivatives. It is also quite possible that the Governing Body will choose to make use of the CGIAR’s MTA as a starting point—a ne- gotiating draft—for the formulation of the Treaty’s standard MTA. Nevertheless, so as not to pre-judge the actions of the Treaty’s Governing Body, this article, in most in- stances, refers to the MTA used by the CGIAR (the current as well as the previous version) and to the Agreements between the FAO and the CGIAR Centres that the MTA is meant to help implement. Despite certain changes in terminology and formulation, there is no reason to believe that the Treaty will represent a radical break with the past—with the FAO- CGIAR Agreements—in terms of what or how much must be done to received germ- plasm before a valid claim of ownership of a new product can be asserted consistent with the terms of the MTA. Thus, a discussion of one should be relevant to the other. 2 According to Elsevier’s Dictionary of Plant Genetic Resources, an accession is: “An entry in a genebank. A sample, cultivated variety, strain, or bulk population maintained at a genetic resources centre or in a plant breeding programme, for conservation or use, e.g. a sample of seeds representing a cultivar, breeding line, or a collected fi led sample, which is held in storage.” See International Board for Plant Genetic Resources, Elsevier’s Dictionary of Plant Genetic Resources, Elsevier, Amsterdam, 1991. ISSUES IN GENETIC RESOURCES NO. 12 C. FOWLER, J. ENGELS AND E. FRISON (COMPILERS) 9 Should we interpret “germplasm” to mean every allele in every sample that falls under the FAO-CGIAR Agreements? Or does the term “designated germplasm” refer to an accession, which is the actual unit of designa- tion with the FAO? What recipients can and cannot do with the “designated germplasm” depends in part on how the term is defi ned. Is it the accession itself? If so, a recipient could not take out IPRs on that material “as re- ceived”. Is it every gene and allele in the ac- cession? In this case, it could be argued that the material could not be used in any way in any breeding programme resulting in an IPR- protected cultivar. In other words, none of the genes or alleles found in the CGIAR col- lections held under the FAO could end up in a protected cultivar or any construction cov- ered by IPRs. What recipients can do with the germ- plasm is directly determined by the wording of the MTA, the instrument used to enforce the FAO-CGIAR Agreements. At present, the standard MTA used system-wide in the CGIAR is vague and subject to confl icting interpretations. It is clear that the MTA pro- hibits intellectual property protection for the accession itself, but such protection would not properly be granted under any existing IPR legislation. The MTA, however, does not explicitly deal with the question of deriva- tives. In the new MTA, the question of what rights might be sought in connection with components of designated accessions is more directly addressed than in the previous ver- sion but is still left somewhat ambiguous by a formulation which prohibits IPRs on parts and components “in the form received”. The FAO-CGIAR Agreements aim to en- courage use of the material. This aim is ad- vanced by promoting research on the materials but hampered if this research on components leads to IPR protection that would restrict the further use of the accession, including the deployment of genes contained within it. The challenge is in defi ning more precisely what can be done by recipients in a way that will encourage research and yet not hamper further access to and use of the mate- rial. In this “age of biotechnology”, few ques- tions will be as important in determining the future status and usefulness of this invaluable resource. Section I of this article examines the lan- guage in the original FAO-CGIAR Agree- ments, in the associated MTA and in “Joint Statements” issued by the FAO and the CGIAR [Annexes 5 and 6], in an effort to understand legally what the term “germ- plasm and related information” means as employed by the FAO and the CGIAR Centres as well as to gain insight into the intentions of the Parties to the Agreement. It also looks at various alternative interpretations of the word “germplasm” and of the implications of using these different alternatives. Section II looks at a related subject: what does it really mean to say that a recipient of germplasm cannot take out IPRs on certain material? What would the recipient have to do to the material—how large would the changes have to be—before the recipient could properly claim IPRs? This Section iden- tifi es and, as part of an intellectual exercise, systematically works through a rather large number of possible approaches and their implications and concludes by describing one or two promising alternatives for dealing with the problem of derivation in the context of a “facilitated access” regime such as those of both the current FAO-CGIAR Agreements and the International Treaty on Plant Ge- netic Resources for Food and Agriculture. I. Searching for defi nitions and intent A. The problem of defi nition The text of the FAO-CGIAR Agreements contains no section on defi nitions of terms. It does, of course, address the question of what is covered under the Agreements. The Preamble to the Agreements observes that: “… the germplasm accessions have been donated or collected on the THE QUESTION OF DERIVATIVES: PROMOTING USE AND ENSURING AVAILABILITY OF PGR INTERNATIONAL PLANT GENETIC RESOURCES INSTITUTE 10 understanding that these accessions will remain freely available and that they will be conserved and used in research on behalf of the international community, in particular developing countries.” This statement seems to reveal an assump- tion that it is the accessions that are desig- nated, because it was the accessions that were donated with the understanding that “these accessions will remain freely available …” (emphasis added). Article 2 states that the Centres place un- der the auspices of the FAO: “… the collections of plant genetic re- sources listed in the Appendix hereto (hereinafter referred to as the ‘desig- nated germplasm’), as catalogued and published by the Centre in print or machine-readable form … The list of designated germplasm will be updated every two years as new accessions are added to the collection.” This is as clear a defi nition of “germ- plasm” as one will fi nd in the Agreements. In this Article, “designated germplasm” means the “collections” being placed under FAO auspices. Moreover, the list of desig- nated germplasm—that is, the list of what is comprised by the collection—will be up- dated as “accessions” are added to the col- lection. The “designated germplasm” is, therefore, a collection of accessions that have been included in the list by the individual Centres and sent to the FAO as part of the Agreements. Designated accessions thus constitute the collection placed under the FAO. This interpretation is consistent with the “list” originally provided to and ac- cepted by the FAO—a list of “accessions”. The Article specifi es that it is the collections (which it is calling “designated germplasm”) “as catalogued and published by the Centre” that are the subject of treatment under the Agreements. As Centres keep catalogues of accessions, but not of individual genes or alleles, it would appear clear that the Parties intended “designated germplasm”, in prac- tice, to mean designated “accessions” and not designated “alleles”. The foregoing interpretation is buttressed by wording contained in statements issued jointly by the FAO and the CGIAR, as well as by existing practice. In the fi rst Joint State- ment,3 [Annexe 5] the FAO and the CGIAR addressed the question of what was meant by “related information” in the term “germ- plasm and related information” found in Article 3 of the Agreements and in the origi- nal MTA used by the CGIAR Centres. The Statement says that this is “information which has been compiled with respect to individual accessions …” (emphasis added). Were “germplasm” in the phrase “germplasm and related information” to refer to genes, presumably “related information” would refer not to accession-level information but to sub-accession level information, such as genomic and molecular information. In the second Joint Statement,4 [Annexe 6] the FAO and the CGIAR address a number of subjects including the management of designated germplasm. Mention is made of factors that might constrain Centres in sup- plying designated germplasm—factors such as “seed viability”. The Statement acknowl- edges that Centres must use “some discretion in determining the size and number of sam- ples to be provided at any given time to a particular recipient” and notes that: “Centres are not obligated to distribute seed or other designated materials when such distributions would re- duce stocks below accepted levels for conservation purposes or when the request is for such a number of samples 3 Issued at the time of the signing of the Agreements in 1994; available at: ‹www.singer.cgiar.org/ booklet.pdf›. ISSUES IN GENETIC RESOURCES NO. 12 C. FOWLER, J. ENGELS AND E. FRISON (COMPILERS) 11 or quantity of a particular accession as to pose an undue burden on the fi nancial or technical resources of the centre or on its ability to meet requests from others.” In each of the Joint Statements, a strong argument can be made that “designated germplasm” was assumed to equal desig- nated accessions. Were the text of the FAO-CGIAR Agree- ments clear and unambiguous, the question of alternative interpretations of the word “germplasm” would be of little note. The fact is that “germplasm” in common scientifi c usage means something different—something more—than the term “accession” covers. Article 1 of the FAO-CGIAR Agreements asserts that the Agreement “shall be construed and applied in a manner consistent with the provisions of the Convention on Biological Diversity and the International Undertaking on Plant Genetic Resources.” Unfortunately, neither of these defi ne “germplasm”. The U.S. National Academy of Sciences, however, has defi ned “germplasm” as: “… seeds, plants, or plant parts that are useful in crop breeding, research, or conservation because of their genetic attributes. Plants, seed, or cultures that are maintained for the purposes of studying, managing, or using the genetic information they possess.”5 The Academy defi nes “genetic resources” as being synonymous with “germplasm”. The Convention on Biological Diversity does not defi ne “germplasm”, but it does defi ne “ge- netic resources” as “genetic material of ac- tual or potential value”. It defines also “genetic material” as “any material of plant, animal, microbial or other origin containing functional units of heredity”. The above defi nitions from the Conven- tion on Biological Diversity and the U.S. National Academy of Sciences cannot close the door on the debate.6 They seem to point to an interpretation of “germplasm” which would focus at the accession level. However, they would also allow for a broader interpre- tation—one that might begin with the acces- sion and proceed to include all of the functional units of heredity found within the accession. B. Assessing the use and impact of different defi nitions CGIAR Centres holding collections under the auspices of the FAO manage those collections as a collection of accessions, not, in practical terms, as a collection of genes and alleles physically separate from accessions. Acces- sions, not genes and alleles, are distributed, recorded and tracked.7 Were “germplasm” in the FAO-CGIAR Agreements to refer to accessions, then the Agreements would be understood as pro- hibiting claims of ownership or the applying for IPRs on the “accessions, as received”. Enforcement of the FAO-CGIAR Agree- ments, while not simple, would be rela- tively straightforward: recipients would be prohibited from taking out IPRs on the ac- cessions. Controversies might be resolved by comparing the material for which protec- tion is sought to the accessions still held in the Centre genebank. Given the limited number of patent and plant breeder rights certifi cates sought annually, the job of ensur- ing that “designated germplasm” remains 4 Issued in 1998; available at: ‹www.singer.cgiar.org/booklet.pdf›. 5 National Research Council, Managing Global Genetic Resources: Agricultural Crop Issues and Policies, National Academy Press, Washington, D.C., 1993. 6 The question of extracted DNA, for example, remains unresolved, but will have to be addressed in some way in negotiations for a standard MTA for use in association with the Treaty. Specifi c treatment of this issue is beyond the scope of this article. THE QUESTION OF DERIVATIVES: PROMOTING USE AND ENSURING AVAILABILITY OF PGR INTERNATIONAL PLANT GENETIC RESOURCES INSTITUTE 12 free of IPRs and in the public domain would be manageable, even if an accession or two periodically “slipped through the cracks”. Of approximately 500,000 accessions “des- ignated” by the CGIAR, fewer than 200 cases of improper IPR applications/protec- tion have been alleged. All but a handful of these allegations have proven baseless. Al- legations associated with fewer than one- thousandth of one percent of total distributions have been substantive enough to provoke action, and in all relevant cases the result was the withdrawal of the applica- tion or of the grant of protection. The low rate of “abuse” does not, of course, excuse those situations in which it has taken place but it does add context and perspective to the magnitude of the “problem”. As shown in Table 1, the CGIAR collec- tions are comprised, apparently more than most government or private collections, of landraces/farmers’ varieties. One would not expect to see tremendous interest in access- ing such materials for the purpose of acquir- ing IPRs on them without alteration or improvement. While the evidence suggests that few have a strong interest in seeking IPRs on desig- nated germplasm, as received, many public- and private-sector institutions are very interested in having access to these materials for research and incorporation into their breeding programmes. Between 1992 and 1994 (the period for which the most comprehensive data is avail- able), genebanks of the eleven Centres hold- ing designated germplasm distributed 406,211 individual samples.8 Nearly one-third of this material (130,508 samples) was distrib- uted to National Agricultural Research Sys- tems (NARS) in developing countries, while 54 percent went to CGIAR Centres them- selves for their own breeding programmes. While distribution varies by Centre and crop, “most centres distribute at least 10% of their total accessions annually—a rate that is higher than that for most national gene- banks”, according to the FAO.9 Virtually all “improved” material distrib- uted by CGIAR Centres contains alleles found within the designated accessions. Likewise, virtually every accession held in a national 7 However, with the fast evolving technologies in the area of molecular genetics and the impact this has on the way germplasm is being managed and distributed, it will be important to re-visit the defi nitions of germplasm collection and accession. The following hierarchical sequence of terms should be kept in mind when doing so: Collection = set of accessions Accession = set of one or more genotypes, treated as a unit within a collection Genotype = the particular combination of genes of an individual plant Haplotype = the symbolic representation of a specifi c combination of linked alleles of related genes Gene = one or more alleles at the same locus of a chromosome. Table 1: Summary comparison of the composition of cgiar, government and private collections of plant genetic resources (percentages of total collection content) Type of material CGIAR Governmental Private Landraces and old cultivars 59 12 9 Wild species and weedy relatives 14 4 6 Advanced cultivars and breeders’ lines 27 18 47 Other/mixed material – 66 38 Source: FAO, The State of the World’s Plant Genetic Resources for Food and Agriculture, FAO, Rome, 1998. ISSUES IN GENETIC RESOURCES NO. 12 C. FOWLER, J. ENGELS AND E. FRISON (COMPILERS) 13 genebank would contain genetic material found within the collections of designated accessions held by CGIAR Centres.10 Use of this “designated germplasm” (broadly de- fi ned) is pervasive in agricultural systems throughout the world. For example: “More than 80% of the wheat and maize varieties being released by na- tional agricultural partners are based on CIMMYT’s germplasm research. Over 75% of the developing world’s total wheat area and about a third of its maize area are now devoted to grow- ing CIMMYT-related varieties.”11 Any changes made or restrictions im- posed on the use of CGIAR-held materials could have tremendous ripple effects through- out world agriculture. In practice, both the CGIAR Centres and the FAO have assumed that the MTA’s prohi- bition against a recipient claiming ownership or applying for IPRs over the designated germplasm refers to the accession, as received, not to every component of it when incorpo- rated into a new cultivar. This approach al- lows for recipients, in conformity with the MTA,12 to use the material in breeding pro- grammes and produce a new cultivar that is legitimately eligible for protection under plant breeder’s rights laws.13 While standards and criteria for protection under UPOV-style cul- tivar protection schemes are relatively straightforward, it must be acknowledged that the MTA used by the CGIAR Centres and approved by the FAO is less so. Signifi cantly, it does not specify how much or how little must be done with the material received be- fore the recipient can apply for IPR protection and still be in compliance with the MTA (see Section II of this article). One could make a radically different in- terpretation of the FAO-CGIAR Agreements and the related MTAs than that offered above. One could assume that each allele in each accession designated under the Agreements with the FAO is covered by those Agree- ments. This would force an alternative inter- pretation of the MTA’s prohibition against applying for IPRs over the designated germ- plasm. This approach is fatally fl awed, as the new Treaty on Plant Genetic Resources itself demonstrates. Countries would not have based their benefi t-sharing mechanism under the Treaty on royalties coming from the use of multilateral-system material in IPR-pro- tected cultivars had they wished to prohibit each and every gene from this material from appearing in a protected cultivar. Neverthe- 8 System-wide Programme on Genetic Resources (SGRP), Report of the Internally Commissioned External Review of CGIAR Genebank Operations, IPGRI, Rome, 1996. 9 FAO, The State of the World’s Plant Genetic Resources for Food and Agriculture, FAO, Rome, 1998. For a more recent and more detailed analysis of transfers of germplasm to and from Centres of the CGIAR, see C. Fowler, M. Smale and S. Gaiji, Unequal Exchange? Recent Transfers of Agricultural Resources and their Implications for Developing Countries, Development Policy Review, Vol. 19, No. 2, 2001. 10 In fact, all humans also contain genes and alleles found within the designated accessions. 11 CGIAR, Recent Accomplishments of the CGIAR International Agricultural Research Centers, CGIAR, Washington, D.C., 1998. 12 Unless otherwise specifi ed, references to the MTA refer equally to the MTA employed by the CGIAR in 2004 and to the previous MTA used by the Centres. As noted, these MTAs are similar and both were developed in consultation with and with the approval of the FAO and the FAO Commission. 13 The innovation here is the result of gene “reassortment” after meiosis, as a result of human effort. Even though all the genes may have been in the genepool previously, the distinct genotype was not previously available. THE QUESTION OF DERIVATIVES: PROMOTING USE AND ENSURING AVAILABILITY OF PGR INTERNATIONAL PLANT GENETIC RESOURCES INSTITUTE 14 less, some individuals have argued that re- cipients should be prevented from applying for IPRs on any cultivar that contains as much as a single allele found in designated mate- rial acquired under the terms of the MTA. Such an interpretation would give rise to massive enforcement problems which neither the CGIAR nor the FAO have the capacity to address at present. No inventory exists of the alleles in CGIAR-designated germplasm col- lections. Moreover, the majority of alleles are widespread geographically within species and many are common among species as well. They are to be widely found in many breeding institutions. It would be diffi cult, if not impossible, in many cases to prove that the source of the gene or allele was the acces- sion provided by the CGIAR Centre under the terms of the MTA. Furthermore, no mechanism exists today for routine monitor- ing of the use or presence of alleles in new cultivars. While this might be possible techni- cally, the costs of checking each new applica- tion for breeder’s rights against all alleles received by the applicant from the CGIAR would be prohibitive. Needless to say, had the FAO and the CGIAR chosen to move to- wards such a defi nition, legal expenses would have dramatically increased. Despite the overwhelming problems in- volved in enforcing such an interpretation, assertion of this position would likely result in a precipitous decline in requests for mate- rial, thus mitigating enforcement diffi culties. For legal and political reasons, many crop breeding organizations would not be inter- ested in gaining access to material that could not be used to produce a protectable culti- var.14 This certainly applies to the private sector, but more and more we fi nd that pub- lic-sector institutions are protecting the prod- ucts of their research programmes. Thus, one would have to weigh the costs in terms of reduced access and reduced use of the mate- rials. The “benefi t” would be that none of the material would end up in a protected cultivar. The purpose of this strategy is unclear, how- ever, when one considers that under UPOV- style breeder ’s rights, protection of the cultivar does not prevent future use of the material by others—even for the purpose of producing another protected cultivar. In other words, under the UPOV system, the designated germplasm does not actually leave the public domain—it continues to be available for use. The new combination of genes represented by the new cultivar (a genotype) is protected, and use of this spe- cifi c combination is restricted of course, but this new combination is different. It is not the same as the designated material as received from the CGIAR. Its components remain available for use, under the same terms as before the grant of plant breeder’s rights. The question of patents—and in particu- lar, patents on genes—is much more prob- lematic and worrisome. In the United States, for example, patents can be obtained for both cultivars and their components. Since passage of the U.S. Plant Patent Act of 1930,15 which provided patent protection for asexually re- produced cultivars of domesticated plants (such as apple, pear, rose, etc.16), patent or patent-like protection has been expanded through legislation and court decisions to include sexually reproduced plant cultivars,17 micro-organisms,18 genes and gene com- plexes,19 characteristics20 and products.21 Trade secrets, contracts, and use of the tort theory of conversion have also been used for the protection of plant germplasm.22 In the context of this discussion, cultivar patenting causes little distress, as patenting of designated material would be prohibited under the existing terms of the MTA as cur- rently interpreted. The question of what the 14 Typically, lawyers will advise clients against using proprietary products or processes without proper authorization in order to avoid any insecurity about title to the fi nal product and the ability to use or sell it. ISSUES IN GENETIC RESOURCES NO. 12 C. FOWLER, J. ENGELS AND E. FRISON (COMPILERS) 15 minimum requirement might be for taking out IPRs would still remain, however. The identifi cation and patenting of a gene found in designated material is possible un- der the laws of a few countries. Such an IPR might limit some things that could be done with the genetic material in the future. It is not clear, however, exactly what limitations would arise, in part because this area of pat- ent law is fl uid and it is diffi cult to predict how the laws will be interpreted and enforced in the future. At a minimum, such laws would prohibit the subsequent, deliberate extraction of the genetic material from an accession and its targeted use by another party. However, will one be allowed to cross an accession containing a patented gene with another one, moving the gene in more conventional ways? The answer appears to be “yes”. Neverthe- less, further research is needed to assess how “gene patenting” might affect use of desig- nated germplasm and how different defi ni- tions of “germplasm and related information” in the MTA will affect the research (and IPR options) of potential recipients of materials from the CGIAR Centres and, later, under the International Treaty on Plant Genetic Re- sources. However, one must bear in mind that changes in legislation as well as develop- ments through case-law will alter the poten- tial impact of this form of IPR on materials held “in trust” or available from the Treaty’s multilateral system. Further research, while warranted, will not provide a defi nitive or lasting answer to the questions posed above. Political decisions will be needed. If “germplasm” in the FAO-CGIAR Agree- ments refers to “accessions”, neither CGIAR Centres nor recipients of designated germ- plasm can claim ownership or seek IPRs over that germplasm, that is, over the designated accession. This raises the questions: can re- cipients of designated accessions seek IPR protection for components (such as geno- types, genes, alleles and DNA sequences) of those accessions? Can they sequence and patent a gene, for example? In a legalistic sense, the Agreements and the Joint State- ments interpreting the Agreements provide no unequivocal answer. But the intent of the 15 Townsend-Parnell Plant Patent Act of 23 May 1930, Public Law No. 245, 71st Congress. 16 These are species which are multiplied asexually for the commercial market by grafting or other “cloning” techniques. The Act, however, excludes potato and such tuber crops. 17 Plant Variety Protection Act of 24 December 1970, 84 Stat. 1542, 7 U.S.C. 2321 et seq., as well as through Ex Parte Hibberd, 227 U.S.P.Q. 443 (Bd. Pat. App. & Int., 1985). 18 Diamond, Commr. Pats. v. Chakrabarty, 447 U.S. 303, 308–309 (1980). 19 Ex Parte Hibberd, supra, footnote 17. 20 The Federal Circuit Court, in Imazio Nursery v. Dania Greenhouses, 69 F. 3rd 1560 (Fed. Cir., 1995), limited the rights of holders of plant patents under the 1930 law to exclude only those who have derived their material directly from the patent holder’s stock. Independent creation is thus an ample defence in an infringement action. Breeders fashioning a new cultivar with a unique trait— in this case a heather cultivar that bloomed in different months than other cultivars—must now seek protection under utility patent statutes for such a characteristic; see Richard Kjeldgaard and David Marsh, Recent United States Developments in Plant Patents, Molecular Breeding, Vol. 2, 1996. 21 Ex Parte Hibberd, supra, footnote 17. 22 See Jeffrey Ihnen and Robert Jondle, Protecting Plant Germplasm: Alternatives to Patent and Plant Variety Protection, in Intellectual Property Rights Associated with Plants, American Society of Agronomy, Madison, Wisconsin, 1989. THE QUESTION OF DERIVATIVES: PROMOTING USE AND ENSURING AVAILABILITY OF PGR INTERNATIONAL PLANT GENETIC RESOURCES INSTITUTE 16 Agreements is nevertheless evident. Such IPR protection runs counter to the goals of the Agreements if it results in preventing or re- stricting the use of the accession. It must be possible to continue to use all accessions held in trust. No institution charged with the responsibility of safeguard- ing genetic diversity for the international community would knowingly provide sam- ples of that diversity for the purpose of fa- cilitating a recipient’s actions that would prevent all others from using the material in the future. This could result in those acces- sions in the public domain simply becoming empty shells, devoid of any practical useful- ness to plant breeders. Such discouragement of use would undermine the rationale for conservation and jeopardize the very future of agriculture. This analysis is offered with the understanding that the current MTA and the new International Treaty on Plant Ge- netic Resources both contain language con- cerning “parts and components” and prohibit application of IPRs to these “in the form received”. The question then is not resolved, but it is made a bit clearer. Obviously, countries, through the Treaty, are expressing the view that they want to prohibit some applications of IPRs to parts and components. But which ones? The answer is contained in the simple, but mysterious phrase, “in the form re- ceived”. Defi ne that phrase and you have defi ned what can and cannot be done, in terms of IPRs, with parts and components. Neither the CGIAR nor the international community has an interest in discouraging research, including that aimed at sequencing genes and discovering their uses. Consistent with the intent of the FAO-CGIAR Agree- ments, one could argue that IPR protection might be permitted on components of acces- sions, if the accession itself remained avail- able for unrestricted use by others, in traditional ways such as for crossing.23 Pursu- ing this train of thought, however, certain restrictions aimed at retaining the rights of others to use the material might also be placed on the seeking of IPRs for components of accessions.24 The balance to be struck between keeping the material in the public domain and encour- aging research and innovation can best be accomplished if one differentiates between the different ways in which a patented gene might be used. If a subsequent recipient of designated germplasm were free to use mod- ern technologies to extract and move the patented gene (that is, without having to honour the patent), this would clearly be a devastating disincentive for such research involving any designated germplasm. The patent would simply provide no protection at all and would be irrelevant. However, if the patent meant that breeders could no lon- ger use the accession in crosses, and farmers could no longer have and use accessions containing the gene, this just as obviously would undermine the intent of the Agree- ments and erode the value of what is now in the public domain.25 The goals of the Agree- ments might best be served if the terms of the MTA allowed IPRs on components only in cases where innovation was demonstrated and only with the guarantee that traditional uses of the accession, including cultivation and crossing in breeding programmes, could continue unhampered. Assuming that “germplasm” as used in the FAO-CGIAR Agreements refers to acces- sions, the MTA would probably need to be amended if the decision were taken that components, if protectable at all, would only be eligible for IPRs in ways that would not 23 In the future, however, such disputes will be resolved not by the CGIAR Centres but by the Governing Body of the International Treaty on Plant Genetic Resources. 24 This subject is taken up in Section II of this article. ISSUES IN GENETIC RESOURCES NO. 12 C. FOWLER, J. ENGELS AND E. FRISON (COMPILERS) 17 unduly prohibit their continued use as de- scribed above. C. “Related information” As previously noted, the Agreement between the FAO and each CGIAR Centre states that the Centre “shall not claim legal ownership over the designated germplasm, nor shall it seek any intellectual property rights over that germplasm or related information.” The “information” referred to is information related to the designated germplasm. While the defi nition of “germplasm” might be open to debate, the meaning of the word “informa- tion” is more certain. The fi rst Joint State- ment of the FAO and the CGIAR Centres on the Agreement Placing CGIAR Germplasm Collections Under the Auspices of the FAO [Annexe 5] says that: “The words ‘related information’ at the end of Article 3(b) refer to information which has been compiled with respect to individual accessions. Such informa- tion includes passport and characteri- zation data and, when available in the databases of the respective genebanks, evaluation data and information on indigenous knowledge.”26 This wording reinforces the view that designated germplasm refers to “accessions”, as it specifi es that related information refers to “accessions”. The FAO-CGIAR Agreements, imple- mented in part through MTAs, require that the CGIAR Centres pass on the obligations concerning the prohibition on claims of ownership and intellectual property rights over designated germplasm and related information to subsequent recipients. There- fore, a recipient of “related information” from a CGIAR Centre cannot, under the terms of the MTA, claim ownership of or seek intellectual property rights over that related information. While the spirit of the Agreements is most assuredly to keep “related information” (as defi ned above) in the public domain, it is not clear whether the MTA would oblige a re- cipient of germplasm to disclose information (characterization, evaluation, etc.) that they discovered or produced or otherwise place such information in the public domain. Prob- ably not. In the MTA, recipients of desig- nated germplasm are “requested” to furnish the Centre providing the material with “per- formance data collected during evaluations”. The CGIAR will, by policy and by inclination, place existing and subsequent related infor- mation (whether assembled by the Centre or provided by subsequent recipients) in the public domain under the terms of the FAO- CGIAR Agreements. There is a question of “timing”: when does “related information” first fall under the terms of the FAO-CGIAR Agreements and thus under the MTA? Information, such as passport and characterization data, gathered routinely and properly at the time of collect- ing and entered into genebank records must be considered as falling under the terms of the Agreements. This is consistent with the requirements of the International Treaty on Plant Genetic Resources, which mandates access to all available passport information and other “associated available non-confi - dential descriptive information”. According to the fi rst Joint Statement is- sued by the FAO and the CGIAR Centres [Annexe 5], when evaluation data and infor- mation on indigenous knowledge are avail- able in the databases of the genebank, it becomes part of the “related information” 25 The authors know of no patent law that would have such far-reaching effects, however. Patent laws applied to such materials are typically restricted to the isolated and purifi ed form of DNA. Naturally occurring genes, in their natural form, cannot be patented. 26 First Joint Statement, supra, footnote 3. THE QUESTION OF DERIVATIVES: PROMOTING USE AND ENSURING AVAILABILITY OF PGR INTERNATIONAL PLANT GENETIC RESOURCES INSTITUTE 18 covered by the genebank. This interpretation, agreed by the FAO and the CGIAR Centres, omits—at least potentially and for a time— evaluation data and information on indige- nous knowledge not in the databases of the genebanks. The logic behind this is that such information may be under development and in need of further refi nement or further veri- fi cation. In the scientifi c community, it would be argued that scientists have a right to ex- plore new ideas and generate data before the public interest overrides and dictates that they disclose it. Indeed, allowing scientists such “freedom” is not just common courtesy; it is an incentive for research and thus in the public interest. Furthermore, it could be ar- gued that premature disclosure of research results and information by public-sector sci- entists might facilitate inappropriate privati- zation by others. As the Joint Statements of the FAO and the CGIAR stress, Centres and Centre scientists must be allowed to manage designated germplasm in keeping with sound scientific standards and practices, which would include a reasonable period for scientists to carry out research and begin developing new technologies and products prior to publication. This approach represents “standard operating procedure” in the CGIAR and the public sector in general. This approach is also mirrored in the new Treaty with regard to the genetic material itself. The Treaty provides that access to genetic re- sources “under development … shall be at the discretion of its developer, during the period of its development”. Other recipients of germplasm, at present, are requested to provide information on germplasm back to the Centres, but there is no strict legal require- ment to do so and no expectation that they would do this so quickly as to produce a disincentive for their own research. Passport and characterization data are typically available in CGIAR genebanks for designated accessions. Today, there is little need or incentive—or even possibility—to claim ownership over such information. Evaluation data and indigenous knowledge are different matters, involving as they do, more research effort and a stronger connec- tion with commercial activities. Under the FAO-CGIAR Agreements [An- nexe 1], Centres (and subsequent recipients) cannot claim ownership over the germplasm and, in addition, they cannot seek IPRs over the germplasm and related information. This wording in Article 3 of the Agreements leaves Centres and recipients of germplasm free to exercise ownership, but not to claim IPRs, over certain information associated with the germplasm. The FAO-CGIAR Agreements allow researchers (including CGIAR research- ers) to carry out scientifi c research in normal and accepted ways. The Agreements do not require instant disclosure of all information generated through research and testing (such as through evaluations). Such a requirement would be burdensome, bureaucratic and unenforceable and would reduce incentives for further research and the publishing of useful scientifi c papers. Such research carried out by CGIAR Centres will typically enter into the public domain, but until that moment it may be considered as under development and as the property of the Centre. Instant disclosure would, in practice, undermine the purposes of the FAO-CGIAR Agreements by giving critical but unrefi ned and possibly even untested, and certainly unexplored, data to those who may wish to mine it for propri- etary purposes.27 It follows from the arguments laid out above that information—for example, that a high level of resistance to a pest exists within a particular accession—should always be- come part of the public record associated with that accession, at least after a period of time has elapsed allowing the researcher who discovered the trait to use this fi nding before declaring it publicly. However, if someone later sequences the resistance gene, there would be no strict obligation for them to make that information public, though they would certainly be encouraged to do so. ISSUES IN GENETIC RESOURCES NO. 12 C. FOWLER, J. ENGELS AND E. FRISON (COMPILERS) 19 D. Summary observations about “germplasm and related information” Currently, CGIAR Centres hold more than 500,000 accessions of plant genetic resources for food and agriculture “in trust” for the international community under the auspices of the FAO. This “designated germplasm” is distributed in large quantities to plant breeders and other researchers under the terms of an MTA. Centres typically man- age and distribute the material in the form of accessions. It is assumed that the MTA’s prohibition against recipients’ acquiring IPRs on the “germplasm and related information” refers to the accession “as received” from the Centre. This practice allows recipients to ac- cess and use the material with few onerous restrictions. It therefore encourages use and development of the material while keeping it available for use in the future by others. One could interpret “germplasm” to mean all alleles in the designated collections of the CGIAR and then prohibit the use of each and every allele in a subsequently produced culti- var. This interpretation would reduce use of the materials signifi cantly with dubious posi- tive consequences. Certain interests might see political benefi ts in the exclusion of all genes and alleles in the CGIAR collections from fi nal protected cultivars. This course of action would effectively prevent the collections from being used in breeding programmes aimed at cultivar protection under the UPOV, a form of IPR that does not affect future availability or use of the designated accession and a form that is becoming increasingly used in both developed and developing countries. Any interpretation should be judged in the context, inter alia, of how it facilitates access and use, one of the goals of the Agreements and, in- deed, of the Convention on Biological Diver- sity and the International Treaty on Plant Genetic Resources for Food and Agriculture. “Gene patenting”, however, poses a unique problem for the handling of “in-trust” genetic materials. The possibility exists that such IPRs might seriously restrict others from accessing and using designated accessions. The intent of the FAO-CGIAR Agreements is thwarted if such IPRs restrict the future use of the accession in traditional breeding pro- grammes and farmers’ fi elds. More research and a careful “watching brief” are needed on this subject. Consideration might be given both to formulating an operational defi nition of “germplasm and related information” and to amending the current MTA, or formulating the future MTA under the International Treaty on Plant Genetic Resources, so as to discourage or prevent the application of any form of IPR to individual components of designated accessions in a way that would restrict traditional uses of the accession. It should be noted that in this era of genomics, gene sequencing has become routine and, in and of itself, is largely devoid of what most people would consider to be “innovation”. Thus, restricting application of IPRs in such instances may not adversely affect the real innovations that are taking place, not through simple sequencing but through assembling the “right genes” into usable genotypes. The term “related information”, as used in the FAO-CGIAR Agreements, refers to information associated with the designated “accession”.28 This includes passport and characterization data. It also includes certain evaluation data and indigenous knowledge, when that information is entered into gene- bank records. Such an interpretation as- sumes, of course, that indigenous knowledge was acquired properly and that such use is allowed. It also assumes that scientists, as customary, have had reasonable time to verify evaluation data and work with the results. Instantaneous disclosure of informa- 27 See C. Fowler, The Status of Public and Proprietary Germplasm and Information: An Assessment of Recent Developments at FAO, IP Strategy Today, No. 7, 2003. THE QUESTION OF DERIVATIVES: PROMOTING USE AND ENSURING AVAILABILITY OF PGR INTERNATIONAL PLANT GENETIC RESOURCES INSTITUTE 20 tion is neither practical nor worthwhile in scientifi c circles and would serve no purpose in the context of the FAO-CGIAR Agree- ments or the Treaty. Information about the sub-accession components of accessions is not automatically considered to be part of the public domain. Instead, as an incentive to research, researchers are given discretion in this matter. As a matter of practice, CGIAR scientists will continue to place such infor- mation in the public domain if and when it furthers the goals of the CGIAR and aids in the development of international public goods. Neither the original FAO-CGIAR Agree- ments nor the subsequent Joint Statements should be interpreted in an overly rigid or mechanistic way when it comes to decipher- ing the meaning of individual phrases such as “germplasm and related information”. All such phrases in the Agreements come within a context—that of advancing the goals of the Agreements. The overriding goal is to ensure that germplasm, and basic information about it, continues to be conserved, managed prop- erly and made available for scientifi c research and plant breeding. Maintaining the sanctity of the public domain will be counterproduc- tive, however, if rules are so rigid as to dis- courage use. A genebank locked tightly to prevent all abuse may as easily prevent all use and, in the process, provide no tangible benefi t to the public. As in so many realms of life, trust and “good faith” are more critical to the success of an agreement or treaty than the words themselves. “Trust” alone cannot substitute for an- swers to legitimate technical questions about what can and cannot be done with desig- nated germplasm, however. Recipients of designated germplasm cannot be faulted for asking how much (or how little) they must do to designated germplasm before they can apply for IPR protection within the bounds of the MTA. The next Section of this article examines this question and looks at alterna- tives for its resolution. II. Defi ning a “derivative”: minimum requirements for taking out intellectual property protection on derivatives of designated germplasm The Agreements signed between the CGIAR Centres and the FAO proscribe the taking out of IPRs on designated germplasm. This material is widely distributed by the Centres, and its use, especially in plant breeding, is encouraged. However, when designated germplasm accessions are used in develop- ing a new cultivar, the question arises as to whether or not the new cultivar derived from a designated accession is suffi ciently different from the designated accession to be eligible for intellectual property protection. This subject has two elements: – what requirements do IPR laws, such as UPOV-style plant breeder’s rights laws, place on an applicant; and – what conditions might a provider of germ- plasm use in producing a derivative set as to how the genetic material can be used and/or protected. Requirements associated with each ele- ment might be different, refl ecting the differ- ent needs and goals of the institutions and governments involved. This article deals with the second of the two elements: the situation faced by the CGIAR as a provider of germ- plasm, including designated germplasm. In addressing this element, the authors neither make any recommendations nor imply the need for changes in the existing UPOV ap- proach to the subject of derivatives. How the UPOV (or any other IPR regime, including 28 Under the Agreements with the FAO, CGIAR Centres are required to make certain information available. This does not prevent them, voluntarily, from making even more information available. In other words, the Agreements establish a minimum, not a maximum. ISSUES IN GENETIC RESOURCES NO. 12 C. FOWLER, J. ENGELS AND E. FRISON (COMPILERS) 21 those involving patenting) deals with this issue and how the CGIAR might deal with conditions of access to genetic resources, while somewhat related, are nevertheless two distinct and different issues. It should be noted that several of the op- tions presented in this article would have the effect of requiring recipients/users of germplasm to forego or renounce certain rights which might otherwise be available to them under applicable IPR laws as a con- dition for access to and use of the material.29 Such a “restriction” imposed for access would not, of course, contravene IPR stat- utes. The restrictions, while legally binding, would be “voluntary” in the sense that those accessing materials from the CGIAR would voluntarily agree to be bound to certain conditions (restrictions) set forth in an MTA as a prerequisite for obtaining and using the materials. The question of derivatives can be ap- proached from many directions. The intel- lectual exercise of constructing “reasonable” defi nitions based on different approaches is a very useful one. At the least, it helps reveal the complexity of the issues and lays bare those options that are inappropriate, unwork- able or otherwise problematic. Without going through such an exercise in the concrete, it is easy to assume that one or another approach is workable or even ideal, when in reality it might be quite impractical. The following Sections A through F present a series of possible defi nitions of “derivative”, each based on a different approach. These represent attempts to draft the most reasonable defi nition possible for each approach, keeping in mind the intentions of the FAO-CGIAR Agreements and using language that might be appropriate in the associated MTA. For illustrative purposes, several defi ni- tions are given for some approaches, present- ing a range in the ease or diffi culty with which the derived material can be made eligible for protection. While it might be possible to con- struct defi nitions based on other criteria (such as differences in population means and/or variances for “n”, continuously variable characters when grown in the same environ- ment, etc.), defi nitions employing such crite- ria are likely to become overly complex. In many cases, an approach that seems simple, straightforward and workable in the abstract becomes complicated and problematic when one attempts to capture it in legal text as is attempted here. The defi nitions below30 relate solely to the protection of plant varieties, whether by patents, plant breeder’s rights or other sui generis systems.31 They are offered without extensive critical commentary—and without endorsement—with the intention of engaging the reader and encouraging objective consid- eration and discussion. It may well be that most readers will fi nd most of the individual options lacking in some respect or another. While the approaches represented in Options A through D may seem reasonable or attrac- tive “in theory”, it is to be expected that upon examining a text embodying the approach, the reader will judge each to be unsuitable for various scientifi c and practical reasons. Option “E” describes several “composite” defi nitions constructed by using combina- tions of different approaches in an attempt to 29 It should be noted that the MTA currently in use in the CGIAR also imposes certain restrictions and conditions, albeit ones that are not easy to interpret with precision. 30 The discussion below excludes issues related to cytoplasmic diversity. 31 The situation (as it applies to CGIAR scientists) with respect to the protection of genes, gene constructs, organelles, etc. identifi ed within, or based on studies of, designated germplasm is already covered in the CGIAR IPR Guidelines, and a further option of how to deal with components of designated germplasm is provided in this article. THE QUESTION OF DERIVATIVES: PROMOTING USE AND ENSURING AVAILABILITY OF PGR INTERNATIONAL PLANT GENETIC RESOURCES INSTITUTE 22 overcome some of the limitations of indi- vidual approaches. Option “F” describes an option that arises from the view that the goal of any defi nition is not to set a mechanical or arbitrary require- ment for derivatives (as certain IPR regimes might do, in effect) but to facilitate access while ensuring “availability for use” by fu- ture recipients and users of germplasm. It is drafted to cover varieties, gene constructs, cell lines, etc. The reader’s attention is drawn to this option, in particular, as worthy of critical attention. A. Defi nitions based on allelic differences 1) “To be eligible for intellectual property protection, the derived material must differ by one (or any other arbitrary num- ber) or more alleles from any individual designated accession in its parentage.” 2) “To be eligible for intellectual property protection, the derived material must dif- fer by a signifi cant number of alleles from any individual designated accession in its parentage.” Note: – Defi nition A.1 would allow designated material having just the addition of a single gene (e.g. through genetic engi- neering) or substitute allele (e.g. through back-crossing) to be eligible for IPR protection. – Definition A.2, while difficult or im- possible to quantify—and hence apply legally—nevertheless gives perhaps a better feel for the intent of the prohibi- tion against IPR protection of designated germplasm. It might be desirable to combine both elements in a defi nition such as: “To be eligible for intellectual prop- erty protection, the derived mate- rial must differ signifi cantly, and by a minimum of 4 alleles, from any individual designated accession in its parentage.”32 B. Defi nitions based on allelic frequencies “To be eligible for intellectual property pro- tection, the allelic frequency of at least one allele (or any other arbitrary number) in the derived material must differ from that in any individual designated accession in its parent- age by more than X percent.”33 Note: – A defi nition such as this might be more appropriate for cross-pollinated species and heterogeneous populations. – Allelic frequencies are diffi cult to measure and monitor. – This defi nition would enable the results of single plant or mass-selection within a single designated germplasm accession to become eligible for protection (assum- ing it met the criteria of the relevant IPR law). 32 DNA marker-aided analysis of genetic variation among hybrids, lines or clones provides a means for determining how distinct two accessions or cultivars are from one another. A core number of DNA markers per each linkage group of the crop species is needed. Christiansen et al. provide a fi gure of the DNA “picture” for such an assessment; see M.J. Christiansen, S.B. Andersen and R. Ortiz, Diversity Changes in an Intensively Bred Wheat Germplasm during the 20th Century, Molecular Breeding 9, 2002, at 1–11. Likewise, Lund et al. show the methods needed to determine the original source of an accession using germplasm repatriation as an example: see B. Lund, R. Ortiz, I. Skovgaard, R. Waugh and S.B. Andersen, Analysis of Potential Duplicates in Barley Gene Bank Collections Using Re-sampling of Microsatellite Data, Theoretical and Applied Genetics 106, 2003, at 1129–1138. 33 The greater the percentage, the greater the changes that have to be made before a derivative is eligible for IPRs. Allelic frequency should be expressed in a different way for polysomic polyploid species. ISSUES IN GENETIC RESOURCES NO. 12 C. FOWLER, J. ENGELS AND E. FRISON (COMPILERS) 23 C. Defi nitions based on phenotype “To be eligible for intellectual property protection, the derived material must differ from any individual designated accession in its parentage by one (or any other arbitrary number) or more traits.”34 Note: – To avoid “cosmetic” breeding situations, the definition could indicate “useful traits” or “traits of agronomic, nutritional or economic signifi cance”. Thus, for ex- ample, in a fuller form, defi nition C could read: “To be eligible for intellectual property protection, the derived material must differ from any in- dividual designated accession in its parentage by one or more traits of agronomic, nutritional or economic signifi cance, each having a (nar- row-sense-) heritability exceeding 0.75 (or a different fi gure).” D. Defi nitions based on breeding action 1) “To be eligible for intellectual property protection, the derived material must, at a minimum, be the result of single plant or mass-selection within a designated accession.” 2) “To be eligible for intellectual property protection, the derived material must be the result of at least one (or any other arbitrary number) hybridization among designated accessions or between desig- nated and non-designated material.” Note: – Either of the following could be added to each of the defi nitions: (i) “The addition of one or more specifi c genes, e.g. through gene transforma- tion, also confers eligibility for protec- tion.” (ii) “The addition of one or more specifi c genes, e.g. through gene transforma- tion, does not confer eligibility for protection.” – In addition, the following could, as ap- propriate, be added to a version of D.2: “However, the addition of a single gene or allele to a designated acces- sion, e.g. through back-crossing or other techniques, is not suffi cient to confer eligibility.” – These defi nitions, while relatively straightfor- ward and easy to put into practice, would be diffi cult to monitor for compliance. E. Composite defi nitions It is obviously possible to construct a very large number of composite defi nitions35 based on the above. For example: 1) Breeding Action + Phenotype: “To be eligible for intellectual property protection, the plant entity or derived material must be a genetic innovation ensuing from human selection after gene re-assortments result- ing from meiosis. Such an entity should be a distinct genotype in an arbitrary number of loci (accounting for in excess of 75 per- cent of trait variation) from both parental 34 A phenotypic index ensuing from quantitative trait data provides some measurement of relatedness between the original source and derivatives, as shown by Ortiz et al. for Nordic spring wheat and barley. Both crop species are self-pollinated species with disomic inheritance. An arbitrary number of DNA markers per chromosome arm that account for in excess of 75 percent of (quantitative) trait variation may assist in this endeavour. The number of DNA markers will depend on species’ breeding system. See R. Ortiz, S. Madsen and S.B. Andersen, Diversity in Nordic Spring Wheat Cultivars (1901-1993), Acta Agriculturæ Scandinavica (Section B Soil and Plant Sciences) 48, 1998, at 229–238; and R. Ortiz, M. Nurminiemi, S. Madsen, O.A. Rognli and Å. Bjørnstad, Cultivar Diversity in Nordic Spring Barley Breeding (1930-1991), Euphytica 123, 2002, at 111–119. THE QUESTION OF DERIVATIVES: PROMOTING USE AND ENSURING AVAILABILITY OF PGR INTERNATIONAL PLANT GENETIC RESOURCES INSTITUTE 24 sources and any other known accession in the gene pool.” 2) Breeding Action + Allelic Difference: “To be eligible for intellectual property pro- tection, the derived material must be the result of at least four hybridizations among designated accessions or between designated and non-designated material. However, the addition of a single gene or allele to a designated accession, through backcrossing or other techniques, is not suffi cient to confer eligibility. In addition, the derived material must differ by six or more alleles from any individual desig- nated accession in its parentage.” 3) Breeding Action + Allelic Frequency: “To be eligible for intellectual property pro- tection, the derived material must be the result of at least two hybridizations among designated accessions, or between designated and non-designated material, and/or the allelic frequency of at least two alleles in the derived material must differ from that in any of the individual designated accessions in its parentage by more than 25 percent.” 4) Allelic Frequency + Phenotype: “To be eli- gible for intellectual property protection, the allelic frequency of at least one allele in the derived material must differ from that in any individual designated accession in its parentage by more than 25 percent and must differ from the individual des- ignated accession in its parentage by one or more traits of high heritability.” 5) Mechanical + Phenotype: “To be eligible for intellectual property protection, the derived material must be the result of at least one hybridization among designated accessions or between designated and non-designated material. In addition, the derived material must differ from any individual designated accession in its parentage by one or more traits of deemed commercial value. The addition of a single gene or allele to a designated accession, through back-crossing or other techniques such as genetic engineering, the selection of a natural or induced mu- tant, or of a somaclonal variant, or the selection of a variant individual from a designated accession, is not suffi cient to confer eligibility.” F. Defi nitions based on availability for use of designated germplasm An alternative approach would be to employ a defi nition which, while allowing for IPRs, aims to ensure that the designated accession or the designated accession and its com- ponents remain available for use by other recipients in defi ned ways. The goal of this approach would be to keep the material in the public domain while encouraging research on designated accessions. Possible provisions incorporating this approach might include: 1) “The recipient of designated germplasm is not prevented from taking out intel- lectual property protection on any new cultivar, gene construct, cell line or other component of the material identifi ed or developed as a result of their research on or with the germplasm, providing the designated material and its components remain within the public domain and continue to be available for further use without restriction.” 2) “The recipient of designated germplasm is not prevented from taking out intellectual property protection on any new cultivar, gene construct, cell line or other compo- nent of the material invented through 35 Particular requirement levels (e.g. differing in parentage by more than 25 percent, the result of at least four hybridizations, etc.) are offered as reasonable requirements within the context of the approach but are still simply illustrative. Different requirement levels could be substituted for those contained herein. ISSUES IN GENETIC RESOURCES NO. 12 C. FOWLER, J. ENGELS AND E. FRISON (COMPILERS) 25 their research on or with the germplasm, providing the designated accession re- mains available for use without restric- tion, and its components remain available for use through traditional means such as hybridizing, selection, etc.” 3) “The recipient of designated germplasm is not prevented from taking out intel- lectual property protection on any new cultivar, gene construct, cell line or other component of the designated material identifi ed or developed as a result of in- vention from their research on or with the in-trust germplasm, providing the germplasm and its components remain in trust with the CGIAR Centre for the benefi t of all humanity, within the public domain and available for any future use without restriction.” To any of the options under “F” might be added the following provision: “The applicant will undertake to dis- close relevant accessions as received to the Offi ce granting the rights and admit them to be ‘prior art’, in the face of which the protectable advance should be judged.” This addition would acknowledge the contribution of designated material and place on record the applicant’s recognition that his/her “invention” must be judged as new specifi cally in relation to materials in the public domain. In cases where IPRs might be challenged, such a requirement would bolster the position of the CGIAR Centres in their efforts to ensure that the spirit of the FAO- CGIAR Agreements is upheld. Note: – Defi nition F.1 would allow for patenting of components, though under somewhat restrictive conditions. For example, when a gene is identifi ed and used together with a promoter, the total construct might be patentable. The original gene, however, would still be fully available as before—in the original material, for example—for use in conventional breeding or even for use in a different construct. Another example might be when a gene is identifi ed but could be patented only for use in species other than the parental one. – Defi nition F.2 employs slightly different wording and a slightly more relaxed ap- proach to IPR protection. Both provisions might require the applicant for IPRs to re- nounce certain rights typically granted by government authorities through patents. The recipient of designated germplasm would presumably be made aware of this situation upon transfer of the designated germplasm and would be able to make a voluntary decision as to whether he/she wished to obtain the designated material under the stated conditions. Concluding remarks The FAO and the CGIAR Centres have fashioned a unique relationship in which the Centres are entrusted with the conserva- tion, management, use and distribution of a signifi cant portion of the world’s biological diversity of economically important crops. This material is held “in trust” by the Centres for the international community. That com- munity has an interest in seeing it remain available for all to use. It also has an interest in encouraging the development and use of these genetic resources. Rules governing access and use must be transparent. Potential users must know what exactly is “publicly” available. They need also to understand what exactly they can do with the material and what they cannot do, including whether and under what circum- stances IPRs might be sought for materials derived from designated germplasm. This article has sought to bring clarity to these issues by proposing how the “germplasm and related information” covered by the FAO-CGIAR Agreements should be inter- preted and by describing a number of op- THE QUESTION OF DERIVATIVES: PROMOTING USE AND ENSURING AVAILABILITY OF PGR INTERNATIONAL PLANT GENETIC RESOURCES INSTITUTE 26 tions for minimum requirements for taking out intellectual property protection on de- rivatives and components of designated germplasm. The FAO, the CGIAR and the international community may choose not to accept any of these options. Indeed, they may choose to retain the status quo in which the question of what can and cannot be done with designated germplasm is left unan- swered. Choosing not to deal with the sub- ject is itself a choice, though perhaps not the best one. Rather than proposing a particular “solution,” this article is offered with the aim of encouraging discussion, intentionality and transparency. ISSUES IN GENETIC RESOURCES NO. 12 C. FOWLER, J. ENGELS AND E. FRISON (COMPILERS) 27 Annexe 1: The Agreement Between [name of Centre] and the Food and Agri- culture Organization of the United Nations (FAO) Placing Collections of Plant Germplasm under the Auspices of FAO Preamble The [Name of Centre] (hereinafter referred to as the “Centre”), supported by the Consulta- tive Group on International Agricultural Re- search (hereinafter referred to as “CGIAR”), and the Food and Agriculture Organization of the United Nations (hereinafter referred to as “FAO”); Considering the importance to humanity of protecting and conserving plant germplasm for future generations; Considering the International Undertaking on Plant Genetic Resources adopted by the FAO Conference at its Twenty-second Session in 1983 (Resolution 8/83) and in particular Article 7 thereof: and the Annexes of the Undertaking adopted by the FAO Conference in 1989 and 1991; Considering that the FAO Commission on Plant Genetic Resources (hereinafter referred to as the “Commission”), as the relevant intergovernmental body in this fi eld, has the responsibility for monitoring of the implementation of Article 7 of the International Undertaking on Plant Genetic Resources; Considering the Memorandum of Under- standing Between the Food and Agriculture Organization of the United Nations and the International Board for Plant Genetic Re- sources (IBPGR) dated September 21, 1990, on the respective roles of the two organizations in establishing, maintaining and managing germplasm collections and setting standards for these collections; Considering the strong support FAO, as one of the co-sponsors, has provided and continues to provide to the CGIAR; Considering the importance of the plant germ- plasm collections held by the Inter national Agriculture Research Centres (IARCs), supported by the CGIAR, as part of the global strategy for germplasm conservation; Considering that the CGIAR adheres to a pol- icy on plant genetic resources which is based on the unrestricted availability of germplasm held in their genebanks; Considering that the germplasm accession have been donated or collected on the understanding that these accessions will remain freely available and that they will be conserved and used in research on behalf of the international community, in particular the developing countries; Considering that the Centre has expressed the wish that its designated germplasm be rec- ognized as part of the international network of ex situ collection (as per the International Undertaking on Plant Genetic Resources) under the auspices of FAO; Have agreed as follows: Article 1: Application of this agreement This Agreement shall be construed and applied in a manner consistent with the provisions of the Convention on Biological Diversity and the International Undertaking on Plant Genetic Resources. Article 2: Basic undertaking The Centre hereby places under the auspices of FAO, as part of the international network of ex situ collections provided for in Article 7 of the International Undertaking on Plant Genetic Resources, the collections of plant ge- netic resources listed in the Appendix hereto (hereinafter referred to as the “designated germplasm”), as catalogued and published by the Centre in print or machine-readable form, in accordance with the terms and con- ditions set forth in this Agreement. The list of designated germplasm will be updated every two years as new accessions are added to the collection. THE QUESTION OF DERIVATIVES: PROMOTING USE AND ENSURING AVAILABILITY OF PGR INTERNATIONAL PLANT GENETIC RESOURCES INSTITUTE 28 Article 3: Status of designated germplasm (a) The Centre shall hold the designated germplasm in trust for the benefi t of the international community, in particular the developing countries in accordance with the International Undertaking on Plant Genetic Resources and the terms and conditions set out in this Agreement. (b) The Centre shall not claim legal owner- ship over the designated germplasm, nor shall it seek any intellectual property rights over that germplasm or related information. Article 6: Policies The Centre recognizes the intergovernmental authority of FAO and its Commission in set- ting policies for the International Network referred to in Article 7 of the International Undertaking and undertakes to consult with FAO and its Commission on proposed policy changes related to the conservation of, or accessibility to, the designated germplasm, subject, always, to the provisions of Article 9 hereinafter. The Centre shall give full con- sideration to any policy changes proposed by the Commission. Article 9: Availability of designated germplasm and related information The Centre undertakes to make samples of the designated germplasm and related infor- mation available directly to users or through FAO, for the purpose of scientifi c research, plant breeding or genetic resources conserva- tion, without restriction. Article 10: Transfer of designated germplasm and related information Where samples of the designated germplasm and/or related information are transferred to any other person or institution, the Cen- tre shall ensure that such other person or institution, and any further entity receiving samples of the designated germplasm from such person or institution, are bound by the conditions set out in Article 3 (b) and, in the case of samples duplicated for safety pur- poses, to the provisions of Article 5 (a). This provision shall not apply to the repa- triation of germplasm to the country that provided such germplasm. ISSUES IN GENETIC RESOURCES NO. 12 C. FOWLER, J. ENGELS AND E. FRISON (COMPILERS) 29 Annexe 2: Relevant parts of the International Treaty on Plant Genetic Resources For Food And Agriculture Preamble The Contracting Parties, Convinced of the special nature of plant ge- netic resources for food and agriculture, their distinctive features and problems needing distinctive solutions; Alarmed by the continuing erosion of these resources; Cognizant that plant genetic resources for food and agriculture are a common concern of all countries, in that all countries depend very largely on plant genetic resources for food and agriculture that originated elsewhere; Acknowledging that the conservation, explora- tion, collection, characterization, evaluation and documentation of plant genetic resources for food and agriculture are essential in meeting the goals of the Rome Declaration on World Food Security and the World Food Summit Plan of Action and for sustainable agricultural development for this and future generations, and that the capacity of develop- ing countries and countries with economies in transition to undertake such tasks needs urgently to be reinforced; Noting that the Global Plan of Action for the Conservation and Sustainable Use of Plant Genetic Resources for Food and Agriculture is an internationally agreed framework for such activities; Acknowledging further that plant genetic resources for food and agriculture are the raw material indispensable for crop genetic improvement, whether by means of farmers’ selection, classical plant breeding or modern biotechnologies, and are essential in adapting to unpredictable environmental changes and future human needs; Affi rming that the past, present and future contributions of farmers in all regions of the world, particularly those in centres of origin and diversity, in conserving, improving and making available these resources, is the basis of Farmers’ Rights; Affi rming also that the rights recognized in this Treaty to save, use, exchange and sell farm- saved seed and other propagating material, and to participate in decision-making regard- ing, and in the fair and equitable sharing of the benefi ts arising from, the use of plant genetic resources for food and agriculture, are fundamental to the realization of Farmers’ Rights, as well as the promotion of Farmers’ Rights at national and international levels; Recognizing that this Treaty and other inter- national agreements relevant to this Treaty should be mutually supportive with a view to sustainable agriculture and food security; Affi rming that nothing in this Treaty shall be interpreted as implying in any way a change in the rights and obligations of the Contracting Parties under other international agreements; Understanding that the above recital is not intended to create a hierarchy between this Treaty and other international agreements; Aware that questions regarding the manage- ment of plant genetic resources for food and agriculture are at the meeting point between agriculture, the environment and commerce, and convinced that there should be synergy among these sectors; Aware of their responsibility to past and future generations to conserve the World’s diversity of plant genetic resources for food and agriculture; Recognizing that, in the exercise of their sover- eign rights over their plant genetic resources for food and agriculture, states may mutu- ally benefi t from the creation of an effective multilateral system for facilitated access to a negotiated selection of these resources and for THE QUESTION OF DERIVATIVES: PROMOTING USE AND ENSURING AVAILABILITY OF PGR INTERNATIONAL PLANT GENETIC RESOURCES INSTITUTE 30 the fair and equitable sharing of the benefi ts arising from their use; and Desiring to conclude an international agree- ment within the framework of the Food and Agriculture Organization of the United Na- tions, hereinafter referred to as FAO, under Article XIV of the FAO Constitution; Have agreed as follows: PART I – INTRODUCTION Article 1 – Objectives 1.1 The objectives of this Treaty are the con- servation and sustainable use of plant genetic resources for food and agricul- ture and the fair and equitable sharing of the benefi ts arising out of their use, in harmony with the Convention on Biological Diversity, for sustainable agriculture and food security. 1.2 These objectives will be attained by closely linking this Treaty to the Food and Agriculture Organization of the United Nations and to the Convention on Biological Diversity. Article 2 – Use of terms For the purpose of this Treaty, the following terms shall have the meanings hereunder assigned to them. These defi nitions are not intended to cover trade in commodities: “In situ conservation” means the conservation of ecosystems and natural habitats and the maintenance and recovery of viable popula- tions of species in their natural surroundings and, in the case of domesticated or cultivated plant species, in the surroundings where they have developed their distinctive properties. “Ex situ conservation” means the conserva- tion of plant genetic resources for food and agriculture outside their natural habitat. “Plant genetic resources for food and agri- culture” means any genetic material of plant origin of actual or potential value for food and agriculture. “Genetic material” means any material of plant origin, including reproductive and vegetative propagating material, containing functional units of heredity. “Variety” means a plant grouping, within a single botanical taxon of the lowest known rank, defi ned by the reproducible expres- sion of its distinguishing and other genetic characteristics. “Ex situ collection” means a collection of plant genetic resources for food and agriculture maintained outside their natural habitat. “Centre of origin” means a geographical area where a plant species, either domesti- cated or wild, fi rst developed its distinctive properties. “Centre of crop diversity” means a geograph- ic area containing a high level of genetic di- versity for crop species in in situ conditions. Article 3 – Scope This Treaty relates to plant genetic resources for food and agriculture. PART II - GENERAL PROVISIONS Article 4 - General Obligations Each Contracting Party shall ensure the conformity of its laws, regulations and pro- cedures with its obligations as provided in this Treaty. PART III - FARMERS’ RIGHTS Article 9 – Farmers’ Rights 9.1 The Contracting Parties recognize the enormous contribution that the local and indigenous communities and farmers of all regions of the world, particularly those in the centres of origin and crop diversity, have made and will continue to make for the conservation and development of ISSUES IN GENETIC RESOURCES NO. 12 C. FOWLER, J. ENGELS AND E. FRISON (COMPILERS) 31 plant genetic resources which constitute the basis of food and agriculture produc- tion throughout the world. 9.2 The Contracting Parties agree that the responsibility for realizing Farmers’ Rights, as they relate to plant genetic resources for food and agriculture, rests with national governments. In accordance with their needs and priori- ties, each Contracting Party should, as appropriate, and subject to its national legislation, take measures to protect and promote Farmers’ Rights, including: (a) protection of traditional knowledge relevant to plant genetic resources for food and agriculture; (b) the right to equitably participate in sharing benefits arising from the utilization of plant genetic resources for food and agriculture; and (c) the right to participate in making decisions, at the national level, on matters related to the conservation and sustainable use of plant genetic resources for food and agriculture. 9.3 Nothing in this Article shall be inter- preted to limit any rights that farm- ers have to save, use, exchange and sell farm-saved seed/propagating material, subject to national law and as appropriate. PART IV - THE MULTILATERAL SYSTEM OF ACCESS AND BENEFIT-SHARING Article 10 – Multilateral System of Access and Benefi t-sharing 10.1 In their relationships with other States, the Contracting Parties recognize the sovereign rights of States over their own plant genetic resources for food and agriculture, including that the authority to determine access to those resources rests with national governments and is subject to national legislation. 10.2 In the exercise of their sovereign rights, the Contracting Parties agree to es- tablish a multilateral system, which is effi cient, effective, and transparent, both to facilitate access to plant genetic resources for food and agriculture, and to share, in a fair and equitable way, the benefi ts arising from the utilization of these resources, on a complementary and mutually reinforcing basis. Article 11 – Coverage of the Multilateral System 11.1 In furtherance of the objectives of con- servation and sustainable use of plant genetic resources for food and agricul- ture and the fair and equitable sharing of benefi ts arising out of their use, as stated in Article 1, the Multilateral System shall cover the plant genetic resources for food and agriculture listed in Annex I, established according to criteria of food security and interdependence. 11.2 The Multilateral System, as identifi ed in Article 11.1, shall include all plant genetic resources for food and agriculture listed in Annex I that are under the management and control of the Contracting Parties and in the public domain. With a view to achieving the fullest possible coverage of the Multilateral System, the Contracting Parties invite all other holders of the plant genetic resources for food and agriculture listed in Annex I to include these plant genetic resources for food and agriculture in the Multilateral System. 11.3 Contracting Parties also agree to take appropriate measures to encourage natural and legal persons within their jurisdiction who hold plant genetic re- sources for food and agriculture listed in Annex I to include such plant genetic resources for food and agriculture in the Multilateral System. 11.4 Within two years of the entry into force of the Treaty, the Governing Body shall assess the progress in including the plant genetic resources for food and agriculture referred to in paragraph 11.3 in the Multilateral System. Following this THE QUESTION OF DERIVATIVES: PROMOTING USE AND ENSURING AVAILABILITY OF PGR INTERNATIONAL PLANT GENETIC RESOURCES INSTITUTE 32 assessment, the Governing Body shall decide whether access shall continue to be facilitated to those natural and legal persons referred to in paragraph 11.3 that have not included these plant genetic resources for food and agriculture in the Multilateral System, or take such other measures as it deems appropriate. 11.5 The Multilateral System shall also in- clude the plant genetic resources for food and agriculture listed in Annex I and held in the ex situ collections of the International Agricultural Research Centres of the Consultative Group on International Agricultural Research (CGIAR), as provided in Article 15.1a, and in other international institutions, in accordance with Article 15.5. Article 12 – Facilitated access to plant genetic resources for food and agriculture within the Multilateral System 12.1 The Contracting Parties agree that facilitated access to plant genetic re- sources for food and agriculture under the Multilateral System, as defi ned in Article 11, shall be in accordance with the provisions of this Treaty. 12.2 The Contracting Parties agree to take the necessary legal or other appropri- ate measures to provide such access to other Contracting Parties through the Multilateral System. To this effect, such access shall also be provided to legal and natural persons under the jurisdiction of any Contracting Party, subject to the provisions of Article 11.4. 12.3 Such access shall be provided in accord- ance with the conditions below: (a) Access shall be provided solely for the purpose of utilization and con- servation for research, breeding and training for food and agriculture, provided that such purpose does not include chemical, pharmaceutical and/or other non-food/feed indus- trial uses. In the case of multiple-use crops (food and non-food), their importance for food security should be the determinant for their inclusion in the Multilateral System and avail- ability for facilitated access. (b) Access shall be accorded expedi- tiously, without the need to track indi- vidual accessions and free of charge, or, when a fee is charged, it shall not exceed the minimal cost involved; (c) All available passport data and, subject to applicable law, any other associated available non-confi den- tial descriptive information, shall be made available with the plant genetic resources for food and agri- culture provided; (d) Recipients shall not claim any intel- lectual property or other rights that limit the facilitated access to the plant genetic resources for food and agriculture, or their genetic parts or components, in the form received from the Multilateral System; (e) Access to plant genetic resources for food and agriculture under devel- opment, including material being developed by farmers, shall be at the discretion of its developer, during the period of its development; (f) Access to plant genetic resources for food and agriculture protected by intellectual and other property rights shall be consistent with relevant international agreements, and with relevant national laws; (g) Plant genetic resources for food and agriculture accessed under the Mul- tilateral System and conserved shall continue to be made available to the Multilateral System by the recipients of those plant genetic resources for food and agriculture, under the terms of this Treaty; and (h) Without prejudice to the other pro- visions under this Article, the Con- tracting Parties agree that access to ISSUES IN GENETIC RESOURCES NO. 12 C. FOWLER, J. ENGELS AND E. FRISON (COMPILERS) 33 plant genetic resources for food and agriculture found in in situ condi- tions will be provided according to national legislation or, in the absence of such legislation, in accordance with such standards as may be set by the Governing Body. 12.4 To this effect, facilitated access, in accord- ance with Articles 12.2 and 12.3 above, shall be provided pursuant to a stand- ard material transfer agreement (MTA), which shall be adopted by the Governing Body and contain the provisions of Ar- ticles 12.3a, d and g, as well as the ben- efi tsharing provisions set forth in Article 13.2d(ii) and other relevant provisions of this Treaty, and the provision that the recipient of the plant genetic resources for food and agriculture shall require that the conditions of the MTA shall apply to the transfer of plant genetic resources for food and agriculture to another person or entity, as well as to any subsequent transfers of those plant genetic resources for food and agriculture. 12.5 Contracting Parties shall ensure that an opportunity to seek recourse is avail- able, consistent with applicable juris- dictional requirements, under their legal systems, in case of contractual disputes arising under such MTAs, recognizing that obligations arising under such MTAs rest exclusively with the parties to those MTAs. 12.6 In emergency disaster situations, the Contracting Parties agree to provide facilitated access to appropriate plant ge- netic resources for food and agriculture in the Multilateral System for the purpose of contributing to the re-establishment of agricultural systems, in cooperation with disaster relief co-ordinators. Article 13 - Benefi t-sharing in the Multilateral System 13.1 The Contracting Parties recognize that facilitated access to plant genetic re- sources for food and agriculture which are included in the Multilateral System constitutes itself a major benefi t of the Multilateral System and agree that ben- efi ts accruing therefrom shall be shared fairly and equitably in accordance with the provisions of this Article. 13.2 The Contracting Parties agree that ben- efi ts arising from the use, including commercial, of plant genetic resources for food and agriculture under the Multilateral System shall be shared fairly and equitably through the fol- lowing mechanisms: the exchange of information, access to and transfer of technology, capacity-building, and the sharing of the benefi ts arising from commercialization, taking into ac- count the priority activity areas in the rolling Global Plan of Action, under the guidance of the Governing Body: (a) Exchange of information: The Contracting Parties agree to make available information which shall, inter alia, encompass cata- logues and inventories, information on technologies, results of techni- cal, scientific and socio-economic research, including characterization, evaluation and utilization, regard- ing those plant genetic resources for food and agriculture under the Multi- lateral System. Such information shall be made available, where non- confi dential, subject to applicable law and in accordance with national capabilities. Such information shall be made available to all Contracting Parties to this Treaty through the information system, provided for in Article 17. (b) Access to and transfer of technology (i) The Contracting Parties under- take to provide and/or facilitate access to technologies for the conservation, characterization, evaluation and use of plant THE QUESTION OF DERIVATIVES: PROMOTING USE AND ENSURING AVAILABILITY OF PGR INTERNATIONAL PLANT GENETIC RESOURCES INSTITUTE 34 genetic resources for food and agriculture which are under the Multilateral System. Recognizing that some technologies can only be transferred through genetic material, the Contracting Parties shall provide and/or facilitate access to such technologies and genetic material which is under the Multilateral System and to improved varieties and genetic material developed through the use of plant genetic resources for food and agriculture under the Multilateral System, in conform- ity with the provisions of Article 12. Access to these technologies, improved varieties and genetic material shall be provided and/ or facilitated, while respecting applicable property rights and access laws, and in accordance with national capabilities. (ii) Access to and transfer of technol- ogy to countries, especially to developing countries and coun- tries with economies in transition, shall be carried out through a set of measures, such as the estab- lishment and maintenance of, and participation in, crop-based thematic groups on utilization of plant genetic resources for food and agriculture, all types of partnership in research and development and in commercial joint ventures relating to the ma- terial received, human resource development, and effective ac- cess to research facilities. (iii) Access to and transfer of technol- ogy as referred to in (i) and (ii) above, including that protected by intellectual property rights, to developing countries that are Contracting Parties, in particular least developed countries, and countries with economies in tran- sition, shall be provided and/or facilitated under fair and most favourable terms, in particular in the case of technologies for use in conservation as well as technolo- gies for the benefi t of farmers in developing countries, especially in least developed countries, and countries with economies in transition, including on con- cessional and preferential terms where mutually agreed, inter alia, through partnerships in research and development under the Multilateral System. Such access and transfer shall be provided on terms which recognize and are consistent with the adequate and effective protection of intellectual property rights. (c) Capacity-building Taking into account the needs of de- veloping countries and countries with economies in transition, as expressed through the priority they accord to building capacity in plant genetic resources for food and agriculture in their plans and programmes, when in place, in respect of those plant genetic resources for food and agri- culture covered by the Multilateral System, the Contracting Parties agree to give priority to (i) establishing and/or strengthening programmes for scientific and technical educa- tion and training in conservation and sustainable use of plant genetic resources for food and agriculture, (ii) developing and strengthening facili- ties for conservation and sustainable use of plant genetic resources for food and agriculture, in particular in developing countries, and countries with economies in transition, and (iii) carrying out scientifi c research preferably, and where possible, in developing countries and countries with economies in transition, in co- operation with institutions of such countries, and developing capacity for such research in fi elds where they are needed. ISSUES IN GENETIC RESOURCES NO. 12 C. FOWLER, J. ENGELS AND E. FRISON (COMPILERS) 35 (d) Sharing of monetary and other benefi ts of commercialization (i) The Contracting Parties agree, under the Multilateral System, to take measures in order to achieve commercial benefit- sharing, through the involve- ment of the private and public sectors in activities identifi ed under this Article, through partnerships and collabora- tion, including with the private sector in developing countries and countries with economies in transition, in research and technology development; (ii) The Contracting Parties agree that the standard Material Transfer Agreement referred to in Article 12.4 shall include a requirement that a recipient who commer- cializes a product that is a plant genetic resource for food and agriculture and that incorporates material accessed from the Mul- tilateral System, shall pay to the mechanism referred to in Article 19.3f, an equitable share of the benefi ts arising from the commer- cialization of that product, except whenever such a product is avail- able without restriction to others for further research and breeding, in which case the recipient who commercializes shall be encour- aged to make such payment. The Governing Body shall, at its fi rst meeting, determine the level, form and manner of the payment, in line with commercial practice. The Governing Body may decide to establish different levels of payment for various categories of recipients who com- mercialize such products; it may also decide on the need to exempt from such payments small farm- ers in developing countries and in countries with economies in transition. The Governing Body may, from time to time, review the levels of payment with a view to achieving fair and equitable sharing of benefi ts, and it may also assess, within a period of five years from the entry into force of this Treaty, whether the mandatory payment requirement in the MTA shall apply also in cases where such commercialized products are available without restriction to others for further research and breeding. 13.3 The Contracting Parties agree that ben- efi ts arising from the use of plant genetic resources for food and agriculture that are shared under the Multilateral Sys- tem should fl ow primarily, directly and indirectly, to farmers in all countries, especially in developing countries, and countries with economies in transition, who conserve and sustainably utilize plant genetic resources for food and agriculture. 13.4 The Governing Body shall, at its fi rst meeting, consider relevant policy and criteria for specific assistance under the agreed funding strategy established under Article 18 for the conservation of plant genetic resources for food and agriculture in developing countries, and countries with economies in transition whose contribution to the diversity of plant genetic resources for food and agriculture in the Multilateral System is signifi cant and/or which have special needs. 13.5 The Contracting Parties recognize that the ability to fully implement the Global Plan of Action, in particular of develop- ing countries and countries with econo- mies in transition, will depend largely upon the effective implementation of this Article and of the funding strategy as provided in Article 18. 13.6 The Contracting Parties shall consider modalities of a strategy of voluntary benefi tsharing contributions whereby Food Processing Industries that benefi t from plant genetic resources for food THE QUESTION OF DERIVATIVES: PROMOTING USE AND ENSURING AVAILABILITY OF PGR INTERNATIONAL PLANT GENETIC RESOURCES INSTITUTE 36 and agriculture shall contribute to the Multilateral System. Article 15 - Ex Situ Collections of Plant Genetic Resources for Food and Agriculture held by the International Agricultural Research Centres of the Consultative Group on International Agricultural Research and other International Institutions 15.1 The Contracting Parties recognize the importance to this Treaty of the ex situ collections of plant genetic resources for food and agriculture held in trust by the International Agricultural Research Centres (IARCs) of the Consultative Group on International Agricultural Research (CGIAR). The Contracting Parties call upon the IARCs to sign agreements with the Governing Body with regard to such ex situ collections, in accordance with the following terms and conditions: (a) Plant genetic resources for food and agriculture listed in Annex I of this Treaty and held by the IARCs shall be made available in accordance with the provisions set out in Part IV of this Treaty. (b) Plant genetic resources for food and agriculture other than those listed in Annex I of this Treaty and collected before its entry into force that are held by IARCs shall be made avail- able in accordance with the provi- sions of the MTA currently in use pursuant to agreements between the IARCs and the FAO. This MTA shall be amended by the Governing Body no later than its second regular ses- sion, in consultation with the IARCs, in accordance with the relevant provisions of this Treaty, especially Articles 12 and 13, and under the following conditions: (i) The IARCs shall periodically in- form the Governing Body about the MTAs entered into, according to a schedule to be established by the Governing Body; (ii) The Contracting Parties in whose territory the plant genetic re- sources for food and agriculture were collected from in situ con- ditions shall be provided with samples of such plant genetic re- sources for food and agriculture on demand, without any MTA; (iii) Benefi ts arising under the above MTA that accrue to the mecha- nism mentioned in Article 19.3f shall be applied, in particular, to the conservation and sustainable use of the plant genetic resources for food and agriculture in ques- tion, particularly in national and regional programmes in devel- oping countries and countries with economies in transition, especially in centres of diversity and the least developedcoun- tries; and (iv) The IARCs shall take appro- priate measures, in accordance with their capacity, to main- tain effective compliance with the conditions of the MTAs, and shall promptly inform the Governing Body of cases of non- compliance. (c) IARCs recognize the authority of the Governing Body to provide policy guidance relating to ex situ collec- tions held by them and subject to the provisions of this Treaty. (d) The scientifi c and technical facili- ties in which such ex situ collections are conserved shall remain under the authority of the IARCs, which under take to manage and administer these ex situ collections in accordance with internationally accepted stand- ards, in particular the Genebank Standards as endorsed by the FAO ISSUES IN GENETIC RESOURCES NO. 12 C. FOWLER, J. ENGELS AND E. FRISON (COMPILERS) 37 Commission on Genetic Resources for Food and Agriculture. (e) Upon request by an IARC, the Secretary shall endeavour to provide appropriate technical support. (f) The Secretary shall have, at any time, right of access to the facilities, as well as right to inspect all activities performed therein directly related to the conservation and exchange of the material covered by this Article. (g) If the orderly maintenance of these ex situ collections held by IARCs is impeded or threatened by whatever event, including force majeure, the Sec- retary, with the approval of the host country, shall assist in its evacuation or transfer, to the extent possible. 15.2 The Contracting Parties agree to pro- vide facilitated access to plant genetic resources for food and agriculture in Annex I under the Multilateral Sys- tem to IARCs of the CGIAR that have signed agreements with the Governing Body in accordance with this Treaty. Such Centres shall be included in a list held by the Secretary to be made available to the Contracting Parties on request. 15.3 The material other than that listed in Annex I, which is received and con- served by IARCs after the coming into force of this Treaty, shall be available for access on terms consistent with those mutually agreed between the IARCs that receive the material and the country of origin of such resources or the coun- try that has acquired those resources in accordance with the Convention on Biological Diversity or other applicable law. 15.4 The Contracting Parties are encouraged to provide IARCs that have signed agreements with the Governing Body with access, on mutually agreed terms, to plant genetic resources for food and agriculture not listed in Annex I that are important to the programmes and activities of the IARCs. 15.5 The Governing Body will also seek to establish agreements for the purposes stated in this Article with other relevant international institutions. Article 21 – Compliance The Governing Body shall, at its fi rst meet- ing, consider and approve cooperative and effective procedures and operational mechanisms to promote compliance with the provisions of this Treaty and to address issues of non- compliance. These procedures and mechanisms shall include monitoring, and offering advice or assistance, including legal advice or legal assistance, when needed, in particular to developing countries and countries with economies in transition. THE QUESTION OF DERIVATIVES: PROMOTING USE AND ENSURING AVAILABILITY OF PGR INTERNATIONAL PLANT GENETIC RESOURCES INSTITUTE 38 International Treaty on Plant Genetic Resources For Food And Agriculture ANNEX I: LIST OF CROPS COVERED UNDER THE MULTILATERAL SYSTEM FOOD CROPS Crop Genus Observations Breadfruit Artocarpus Breadfruit only. Asparagus Asparagus Oat Avena Beet Beta Brassica complex Brassica et al. Genera included are: Brassica, Armoracia, Barbarea, Camelina, Crambe, Diplotaxis, Eruca, Isatis, Lepidium, Raphanobrassica, Raphanus, Rorippa, and Sinapis. This comprises oilseed and vegetable crops such as cabbage, rapeseed, mustard, cress, rocket, radish, and turnip. The species Lepidium meyenii (maca) is excluded. Pigeon Pea Cajanus Chickpea Cicer Citrus Citrus Genera Poncirus and Fortunella are included as root stock. Coconut Cocos Major aroids Colocasia, Xanthosoma Major aroids include taro, cocoyam, dasheen and tannia. Carrot Daucus Yams Dioscorea Finger Millet Eleusine Strawberry Fragaria Sunfl ower Helianthus Barley Hordeum Sweet Potato Ipomoea Grass pea Lathyrus Lentil Lens Apple Malus Cassava Manihot Manihot esculenta only. Banana / Plantain Musa Except Musa textilis. Rice Oryza Pearl Millet Pennisetum Beans Phaseolus Except Phaseolus polyanthus. Pea Pisum ISSUES IN GENETIC RESOURCES NO. 12 C. FOWLER, J. ENGELS AND E. FRISON (COMPILERS) 39 Crop Genus Observations Rye Secale Potato Solanum Section tuberosa included, except Solanum phureja. Eggplant Solanum Section melongena included. Sorghum Sorghum Triticale Triticosecale Wheat Triticum et al. Including Agropyron, Elymus, and Secale. Faba Bean / Vetch Vicia Cowpea et al. Vigna Maize Zea Excluding Zea perennis, Zea diploperennis, and Zea luxurians. FORAGES Genera Species LEGUME FORAGES Astragalus chinensis, cicer, arenarius Canavalia ensiformis Coronilla varia Hedysarum coronarium Lathyrus cicera, ciliolatus, hirsutus, ochrus, odoratus, sativus Lespedeza cuneata, striata, stipulacea Lotus corniculatus, subbifl orus, uliginosus Lupinus albus, angustifolius, luteus Medicago arborea, falcata, sativa, scutellata, rigidula, truncatula Melilotus albus, offi cinalis Onobrychis viciifolia Ornithopus sativus Prosopis affi nis, alba, chilensis, nigra, pallida Pueraria phaseoloides Trifolium alexandrinum, alpestre, ambiguum, angustifolium, arvense, agrocicerum, hybridum, incarnatum, pratense, repens, resupinatum, rueppellianum, semipilosum, subterraneum, vesiculosum GRASS FORAGES Andropogon gayanus Agropyron cristatum, desertorum Agrostis stolonifera, tenuis THE QUESTION OF DERIVATIVES: PROMOTING USE AND ENSURING AVAILABILITY OF PGR INTERNATIONAL PLANT GENETIC RESOURCES INSTITUTE 40 Genera Species Alopecurus pratensis Arrhenatherum elatius Dactylis glomerata Festuca arundinacea, gigantea, heterophylla, ovina, pratensis, rubra Lolium hybridum, multifl orum, perenne, rigidum, temulentum Phalaris aquatica, arundinacea Phleum pratense Poa alpina, annua, pratensis Tripsacum laxum OTHER FORAGES Atriplex halimus, nummularia Salsola vermiculata ISSUES IN GENETIC RESOURCES NO. 12 C. FOWLER, J. ENGELS AND E. FRISON (COMPILERS) 41 Annexe 3: Material Transfer Agreement (MTA) (1998) The material contained herein is being furnished by [Centre] under the following conditions: Designated Germplasm [Centre] is making the material described in the attached list available as part of its policy of maximizing the utilization of genetic ma- terial for research. The material was either developed by [Centre]; or was acquired prior to the entry into force of the Convention on Biological Diversity; or if it was acquired after the entering into force of the Convention on Biological Diversity, it was obtained with the understanding that it could be made freely available for any agricultural research or breeding purposes. The material is held in trust under the terms of an agreement between [Centre] and FAO, and the recipient has no rights to obtain Intellectual Property Rights (IPR) on the germplasm or related information. The recipient may reproduce the seed and use the material for agricultural research and breeding purposes and may distribute it to other parties provided the recipient is also willing to accept the conditions of this agreement.1 The recipient, therefore, hereby agrees not to claim ownership over the germplasm to be received, nor to seek IPR over that germplasm or related information. He/She further agrees to ensure that any subsequent person or in- stitution to whom he/she may make samples of the germplasm available, is bound by the same provision and undertakes to pass on the same obligations to future recipients of the germplasm. [Centre] makes no warranties as to the safety or title of the material, nor as to the accuracy or correctness of any passport or other data provided with the material. Neither does it make any warranties as to the quality, viabil- ity, or purity (genetic or mechanical) of the material being furnished. The phytosanitary condition of the material is warranted only as described in the attached phytosanitary certificate. The recipient assumes full re- sponsibility for complying with the recipient nation’s quarantine/biosafety regulations and rules as to import or release of genetic material. Upon request, [Centre] will furnish informa- tion that may be available in addition to what- ever is furnished with the seed. Recipients are requested to furnish [Centre] performance data collected during evaluations. The material is supplied expressly condi- tional on acceptance of the terms of this agreement. The recipient’s acceptance of the material constitutes acceptance of the terms of this Agreement. 1 This does not prevent the recipient from releasing or reproducing the seed for purposes of making it directly available to farmers or consumers for cultivation, provided that the other conditions set out in the MTA are complied with. THE QUESTION OF DERIVATIVES: PROMOTING USE AND ENSURING AVAILABILITY OF PGR INTERNATIONAL PLANT GENETIC RESOURCES INSTITUTE 42 ISSUES IN GENETIC RESOURCES NO. 12 C. FOWLER, J. ENGELS AND E. FRISON (COMPILERS) 43 Annexe 4: Material Transfer Agreement for Plant Genetic Resources Held in Trust by the [Centre]1,2 (2003) The plant genetic resources (hereinafter re- ferred to as the “material”) contained herein are being furnished by the [Centre] under the following conditions: The [Centre] is making the material described in the attached list available as part of its pol- icy of maximizing the utilization of material for research, breeding and training. The mate- rial was either developed by the [Centre]; or was acquired prior to the entry into force of the Convention on Biological Diversity; or if it was acquired after the entering into force of the Convention on Biological Diversity, it was obtained with the understanding that it could be made available for any agricultural research, breeding and training purposes under the terms and conditions set out in the agreement between the [Centre] and FAO dated 26 October 1994. The material is held in trust under the terms of this agreement, and the recipient has no rights to obtain Intellectual Property Rights (IPRs) on the material or related information. The recipient may utilize and conserve the material for research, breeding and training and may distribute it to other parties pro- vided such other parties accept the terms and conditions of this agreement.3 The recipient, therefore, hereby agrees not to claim ownership over the material, nor to seek IPRs over that material, or its genetic parts or components, in the form received. The recipient also agrees not to seek IPRs over related information received. The recipient further agrees to ensure that any subsequent person or institution to whom he/she may make samples of the material available, is bound by the same provisions and undertakes to pass on the same obliga- tions to future recipients of the material. The [Centre] makes no warranties as to the safety or title of the material, nor as to the ac- curacy or correctness of any passport or other data provided with the material. Neither does it make any warranties as to the quality, vi- ability, or purity (genetic or mechanical) of the material being furnished. The phytosanitary condition of the material is warranted only as described in the attached phytosanitary certificate. The recipient assumes full re- sponsibility for complying with the recipient nation’s quarantine and biosafety regulations and rules as to import or release of genetic material. Upon request, the [Centre] will furnish information that may be available in ad- dition to whatever is furnished with the material. Recipients are requested to fur- nish the [Centre] with related data and information collected during evaluation and utilization. 1 This MTA covers materials which are being transferred before the entry into force of the International Treaty on Plant Genetic Resources for Food and Agriculture. The Treaty envisages that the [Centre] will enter into an agreement with the Governing Body of the Treaty, once the Treaty enters into force. The [Centre] has indicated its intention to conclude such an agreement with the Governing Body. This agreement, in line with the Treaty, will provide for new MTAs and benefi t-sharing arrangements for materials transferred after the entry into force of the agreement. 2 The attention of the recipient is drawn to the fact that the details of the MTA, including the identity of the recipient, will be made publicly available. 3 This does not prevent the recipients from releasing the material for purposes of making it directly available to farmers or consumers for cultivation, provided that the other conditions set out in this MTA are complied with. THE QUESTION OF DERIVATIVES: PROMOTING USE AND ENSURING AVAILABILITY OF PGR INTERNATIONAL PLANT GENETIC RESOURCES INSTITUTE 44 The recipient of material provided under this MTA is encouraged to share the benefi ts accruing from its use, including commercial use, through the mechanisms of exchange of information, access to and transfer of technology, capacity building and sharing of benefi ts arising from commercialization. The [Centre] is prepared to facilitate the sharing of such benefi ts by directing them to the conservation and sustainable use of the plant genetic resources in question, particu- larly in national and regional programmes in developing countries and countries with economies in transition, especially in cen- tres of diversity and the least developed countries. The material is supplied expressly condi- tional on acceptance of the terms of this Agreement. The recipient’s acceptance of the material constitutes acceptance of the terms of this Agreement. ISSUES IN GENETIC RESOURCES NO. 12 C. FOWLER, J. ENGELS AND E. FRISON (COMPILERS) 45 Annexe 5: [First] Joint Statement of FAO and the CGIAR Centres on the Agreement Placing CGIAR Germplasm Collections under the Auspices of FAO (1994) The International Agricultural Research Centres of the Consultative Group on Inter- national Agricultural Research (the Centres), which hold plant genetic resources in trust in their genebanks, listed at the end of this joint statement, have placed these collections under the auspices of FAO as part of the In- ternational Network of Ex Situ Collections, under agreements signed with FAO (the Agreement). The text of the Agreement is essentially that approved by the Commission on Plant Genetic Resources (CPGR) in April 1993 and the FAO Conference in November 1993 with the modifi cations introduced into the text to refl ect the concerns expressed by the CPGR on certain points. The modifi cations deal with (i) clarifi cation of the concept of trusteeship and benefi ciary, in particular as it relates to the concept of ownership; (ii) obligations with respect to the conservation of germplasm and its availability that would flow from the concept; (iii) the policy role of the CPGR; and (iv) the duration of the agreement and opportunities for its review by the CPGR. The modifi ed draft agreement was further commented on by the Working Group of the CPGR at its ninth session (Rome, 11-12 May 1994), which expressed its concern that the draft agreement, substantially in its present form should be concluded as soon as possible. In so doing the Working Group drew attention to the need to clarify the implication of the words “without restriction” at the end of Article 9, in the light of the Convention on Biological Diversity and the ongoing process of renegotiation of the International Undertaking on Plant Genetic Resources. It was suggested that the words either be deleted or be clarifi ed in a joint statement, by the parties to the agreement, to be presented to the CPGR. The text of the Agreement to be signed on 26 October 1994 is identical to that presented to the Working Group in May 1994, with the addition, at the beginning of Article 9, of the expression “Subject to the provisions of Article 10 below”. In considering the final text of the Agreement, the common understanding of the parties concerning certain of its provisions is hereby communicated to the Commission on Plant Genetic Resources as follows: 1. Article 3(b): This article does not prevent the Centres from using instruments such as material transfer agreements when they are designed to ensure the materials distributed remain in the public domain as is required under Article 10. 2. Article 3(b): The words “related informa- tion” at the end of Article 3(b) refer to information which has been compiled with respect to individual accessions. Such information includes passport and characterization data and, when avail- able in the databases of the respective genebanks, evaluation data and informa- tion on indigenous knowledge. 3. Article 9: The words “without restriction” at the end of Article 9 should be inter- preted consistently with the Convention on Biological Diversity and as not in any way affecting the rights of countries of origin under this Convention. 4. Article 9: The words “Subject to the provi- sions of Article 10 below” were added at the beginning of the Article to clarify that the words “without restriction” in Article 9 are not interpreted as a limitation on the ability of the Centres to obtain commit- ments from persons and entities receiv- ing samples of designated germplasm as stated in Article 10 5. Article 10: With respect to the transfer of samples of designated germplasm, the requirements of Article 10 will be satisfi ed by arrangements, such as material transfer agreements, that require the recipient not to seek intellectual property protection on the material and to pass on the same obli- gation to subsequent recipients. Similarly, with respect to the transfer of duplicates of collections, or parts thereof, for safety purposes, the requirements of Article 10 will be satisfi ed by an agreement under THE QUESTION OF DERIVATIVES: PROMOTING USE AND ENSURING AVAILABILITY OF PGR INTERNATIONAL PLANT GENETIC RESOURCES INSTITUTE 46 which the recipient institution undertakes to observe the maintenance obligations set out in Article 5(a). However, in neither case will the source Centre be under an obligation to monitor the compliance of the recipient with these undertakings; the obligation of the source Centre will be limited to obtaining such undertakings on the part of the recipient. 6. The parties to the Agreement recognize that the conclusion of the Agreement represents but one stage of a continuing, dynamic process and agree to continue the dialogue in the context of the imple- mentation of the Convention on Biological Diversity and the FAO Global System on Plant Genetic Resources. They will consult from time to time to review these matters and to consider such modifi cations as may be appropriate in the circumstances. Centro Internacional de Agricultura Tropi- cal (CIAT) Centro Internacional de Mejoramiento de Maiz y Trigo (CIMMYT) Centro Internacional de la Papa (CIP) International Center for Agricultural Research in the Dry Areas (ICARDA) International Center for Research in Agro- forestry (ICRAF) International Crops Research Institute for the Semi-Arid Tropics (ICRISAT) International Institute for Tropical Agriculture (IITA) International Livestock Centre for Africa (ILCA) International Plant Genetic Resources Institute (IPGRI)/International Network for the Improvement of Banana and Plantain (INIBAP) International Rice Research Institute (IRRI) West Africa Rice Development Associa- tion (WARDA) Centre for International Forestry Research (CIFOR) ISSUES IN GENETIC RESOURCES NO. 12 C. FOWLER, J. ENGELS AND E. FRISON (COMPILERS) 47 Annexe 6: Second Joint Statement of FAO and the CGIAR Centres on the Agreement Placing CGIAR Germplasm Collections under the Auspices of FAO (1998) A Joint Statement issued by FAO and the CGIAR in conjunction with the signing of the FAO-CGIAR Agreements placing CGIAR Germplasm Collections under the auspices of FAO observed that: "The parties to the Agreement recog- nize that the conclusion of the Agree- ments represents but one stage of a continuing, dynamic process and agree to continue the dialogue in the context of the implementation of the Conven- tion on Biological Diversity and the FAO Global System on Plant Genetic Resources. They will consult from time to time to review these matters and to consider such modifi cation as may be appropriate in the circumstances." FAO and the CGIAR have consulted fre- quently since the Agreements were con- cluded in 1994 in order to review the implementation of the Agreements. The Parties understand and agree that: While Centres distribute germplasm designated under the FAO/CGIAR Agreements through Material Transfer Agreements which prohibit the recipient, or any subsequent recipient, from taking out intellectual property rights, the CGIAR cannot guarantee that recipients will abide by the terms of the MTA. Violations may take place. However, in such cases the Parties commit themselves to taking appropriate remedial action, in accordance with the following agreed procedures: When Centres become aware of a possible violation of their MTAs by a recipient of germplasm, the Centres will henceforth voluntarily undertake the following actions in response to the perceived violation. 1. The Centres will request an explanation. Upon failure to receive a satisfactory and timely explanation for the situation from the germplasm recipient, the Centres will notify the recipient that a violation is thought to have occurred and request that the recipient cease and desist in its ef- forts to obtain intellectual property rights over the material, or renounce such rights or ownership if they have already been granted or claimed. 2. The Centres will notify the proper regula- tory body in the relevant country of the possibility that the MTA has been violated, and bring to their attention the fact that the grant of intellectual property rights may, therefore, have been inappropriate in the case of the material obtained from the CGIAR. 3. The Centres will notify IPGRI and the FAO Commission on Genetic Resources for Food and Agriculture, through its Secretariat, of the possible violation of the MTA under the Agreements with FAO. The Centres reserve the right to take other action, including legal action, as they might deem feasible and appropriate to en- force the MTAs and preserve the integrity of the Agreements with FAO. In this regard, it would be the intent of the Centres to work in cooperation with FAO, under whose auspices the materials are held in trust by the CGIAR for the benefit of the international community. The Centres recognize that many accessions designated under the Agreements with FAO, were distributed to plant breeders and researchers prior to designation in keeping with the CGIAR policy for providing “unrestricted availability” to germplasm - as noted in the Preamble of Agreements. In dealing with this situation, Centres will request and urge that no intellectual property rights be sought for designated germplasm that was distributed prior to its designation under the FAO-CGIAR Agreement. Periodic reports will be presented to the Commission on Genetic Resources for Food and Agriculture on the actions taken in support of the objectives of the Agreements between the CGIAR Centres and FAO. In considering the text of the Agreement, the common understanding of the parties THE QUESTION OF DERIVATIVES: PROMOTING USE AND ENSURING AVAILABILITY OF PGR INTERNATIONAL PLANT GENETIC RESOURCES INSTITUTE 48 concerning certain of its provisions is, as follows: Under the terms of the Agreements (Article 9), the Centres undertake “to make samples of the designated germplasm available directly to users or through FAO for the purpose of scientific research, plant breeding or genetic resource conservation, without restriction.” It is implicit in this undertaking that users will make only reasonable requests for these specific purposes, and that the liability of the Centres would not extend to the fulfillment of unreasonable requests. Sound management practices as well as practical or even biological constraints (such as seed availability or the health status of a sample) may at times make it diffi cult or inappropriate for centres to provide germplasm designated under the Agreements for the purposes spelled out in Article 9. It is understood that centres must use some discretion in determining the size and number of samples to be provided at any given time to a particular recipient. Centres are not obligated to distribute seed or other designated materials when such distributions would reduce stocks below accepted levels for conservation purposes, or when the request is for such a number of samples or quantity of a particular accession as to pose an undue burden on the fi nancial or technical resources of the centre or on its ability to meet requests from others. In such cases, the centre may ask that the recipient cover the actual costs of multiplying the relevant accessions. In cases of limited supplies, immediate availability of materials cannot be guaranteed. Such availability will follow a process of multiplication. Centres are not obligated to supply quantities of a sample which exceed basic requirements for the purposes stated in Article 9. Recipients are advised that they may need to undertake their own seed multiplication when existing sample sizes are small (such as in the case with many accessions of wild relatives) or when demand for a particular sample exceeds supply. In fi ling requests for material for conservation purposes alone, users are invited to note the Global Plan of Action’s objectives of “safeguarding as much existing unique and valuable diversity as possible in ex situ collections,” while reducing “unnecessary and unplanned redundancy in current programmes.” In cases when a centre cannot fully or immediately meet a request, the centre will enter into a discussion with the requesting entity to develop and agree upon a plan and schedule for the supply of materials. This process might establish an agreed list of accessions to which priority would be given. Some designated accessions cannot be multiplied without considerable cost. For example, certain accessions of woody species may take upwards of 10 hectares of land and 30 years to multiply. Similarly, supplying materials of vegetatively propagated species can involve very time-consuming and expen- sive procedures. While centres endeavour to supply materials free of cost, in such circum- stances it would be unreasonable to expect that centres could guarantee unlimited quan- tities or immediate availability of all desig- nated germplasm. Users are encouraged to exercise good judgement and appropriate constraint in requests for such materials. At their discretion, centres may request that us- ers cover all or part of the costs involved in multiplication. Centres are neither obligated nor advised to distribute samples that do not meet health or quarantine standards, or whose transfer could pose the danger of a spread of pests or disease. Centres will inform those requesting materials of the danger which might be posed by invasiveness in those cases where they perceive such dangers to be signifi cant, and of the need for the prior informed consent of the recipient Government for the import of such materials. Materials will then be sup- plied upon receipt of such prior informed consent. ISSUES IN GENETIC RESOURCES NO. 12 C. FOWLER, J. ENGELS AND E. FRISON (COMPILERS) 49 Article 2 provides that “The list of desig- nated germplasm will be updated every two years as new accessions are added to the collection.” This does not preclude Centres from adding new germplasm to the list of designated germplasm without having to wait for the biennial updating of the lists. In such cases, the status of particular germ- plasm as “designated germplasm” becomes effective immediately upon a centre’s deter- mining that it is designating the germplasm under the Agreement and managing the germplasm under the terms of the Agree- ment. The additional designations will be consolidated into updated lists, which will be notifi ed to FAO every two years or more frequently as may be appropriate. As management and information systems improve and as genomic information about accessions becomes available, centres will update the list of materials covered under the Agreements. In addition to adding new materials, centres may fi nd, for example, that particular accessions have been designated more than once; that an accession’s registration number conveyed to FAO on the list of designated germplasm referred to in Article 2, may be incorrect or no longer correspond to an actual accession in the centre’s genebank; or that an accession may, through natural or accidental causes, have lost viability. Logically, such “accessions” will no longer be considered as designated under the terms of the Agreement. The Centre or Centres concerned will notify FAO of any proposals for the deletion of accessions from the list of designated germplasm for such reasons and will provide FAO with a statement of the reasons therefore. THE QUESTION OF DERIVATIVES: PROMOTING USE AND ENSURING AVAILABILITY OF PGR INTERNATIONAL PLANT GENETIC RESOURCES INSTITUTE 50 ISSUES IN GENETIC RESOURCES NO. 12 C. FOWLER, J. ENGELS AND E. FRISON (COMPILERS) 51 Cary Fowler Professor/Director of Research Center for International Environment and Development Studies (Noragric), Agricultural University of Norway Aas, Norway and Senior Advisor to the Director General International Plant Genetic Resources Institute (IPGRI) Rome, Italy Email: c.fowler@cgiar.org Geoffrey Hawtin Interim Secretary, Global Crop Diversity Trust Director General, IPGRI (until August 2003) Rome, Italy Email: geoff.hawtin@fao.org Rodomiro Ortiz (Acting) Deputy-Director General/Director Research-for-Development, International Institute of Tropical Agriculture (IITA) Ibadan, Nigeria Email: r.ortiz@cgiar.org Masa Iwanaga Director General International Maize and Wheat Improvement Center (CIMMYT) El Batan, Mexico Email: m.iwanaga@cgiar.org Jan Engels Director, Genetic Resources Science and Technology Group IPGRI Rome, Italy Email: j.engels@cgiar.org Author affi liation and contacts ISBN 92-9043-643-3