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27. Options for Governing the Microbial Commons
– Michael Halewood
72

Bioversity International, Italy

Bioversity International is one of 15 International Agricultural Research Centers supported by the Consultative Group on International Agriculture Research, often referred to as the CGIAR Centers. Most of my work involves assessing the impact of policies and policy-making processes on the use and conservation of genetic resources for food agriculture. In recent years, I have also dedicated a considerable amount of time to coordinating the representation of the CGIAR centers, as observers, in the negotiations of international access and benefit sharing agreements. The CGIAR centers’ main concern has been with plant genetic resources, though lately we have become increasingly interested in contributing to the development of access and benefit sharing norms that support the use and conservation of other genetic resources for food and agriculture, including microbial genetic resources used in agriculture production systems and plant pathology research. In particular, we are interested in promoting the development of an internationally coordinated system for the common pooling, management and use of agricultural microbial genetic resources. We see such a system (or systems) as an essential supportive component of the agricultural research and development continuum. It is for this reason that we are very pleased to participate in this meeting focusing on the development of the microbial commons.

In this presentation, I am going to focus on challenges associated with populating the microbial commons, on an ongoing, dynamic basis, with previously unavailable, microbial genetic diversity. I am going to focus in particular on challenges associated with access and benefit sharing, and the impact that the Convention on Biological Diversity (CBD) has (or has not) had to date with respect to those challenges. Ultimately, I will argue that intergovernmental participation in developing international norms and administrative mechanisms to support the microbial commons will be essential to overcoming these challenges. I will also identify opportunities for champions of the microbial commons to engage in ongoing international policy-making processes in pursuit of the necessary policy support.

Jerome Reichman already highlighted a number of the most essential components of the microbial commons. Among other things, he stressed the importance of establishing, up-front, access and benefit-sharing terms that are reflected in a single, standardized material transfer agreement that would accompany all transfers of materials in the commons. This is an essential aspect of the commons that would contribute to lowering transaction costs associated with using microbial genetic resources in agricultural research. Furthermore, the benefit sharing terms that are ultimately agreed-upon could encourage would-be depositors to overcome reservations they may have about depositing materials in publically-accessible culture collections. My presentation addresses access and benefit sharing related issues that will need to be resolved before it is reasonable to expect wide-spread adoption and use of such a standardized Materials Transfer Agreement (MTA) in the context of the microbial commons.

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72 Presentation slides available at http://sites.nationalacademies.org/xpedio/idcplg?IdcService=GET_FILE&dDocName=PGA_054720&RevisionSelectionMethod=Latest.



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27. Options for Governing the Microbial Commons – Michael Halewood72 Bioversity International, Italy Bioversity International is one of 15 International Agricultural Research Centers supported by the Consultative Group on International Agriculture Research, often referred to as the CGIAR Centers. Most of my work involves assessing the impact of policies and policy-making processes on the use and conservation of genetic resources for food agriculture. In recent years, I have also dedicated a considerable amount of time to coordinating the representation of the CGIAR centers, as observers, in the negotiations of international access and benefit sharing agreements. The CGIAR centers’ main concern has been with plant genetic resources, though lately we have become increasingly interested in contributing to the development of access and benefit sharing norms that support the use and conservation of other genetic resources for food and agriculture, including microbial genetic resources used in agriculture production systems and plant pathology research. In particular, we are interested in promoting the development of an internationally coordinated system for the common pooling, management and use of agricultural microbial genetic resources. We see such a system (or systems) as an essential supportive component of the agricultural research and development continuum. It is for this reason that we are very pleased to participate in this meeting focusing on the development of the microbial commons. In this presentation, I am going to focus on challenges associated with populating the microbial commons, on an ongoing, dynamic basis, with previously unavailable, microbial genetic diversity. I am going to focus in particular on challenges associated with access and benefit sharing, and the impact that the Convention on Biological Diversity (CBD) has (or has not) had to date with respect to those challenges. Ultimately, I will argue that intergovernmental participation in developing international norms and administrative mechanisms to support the microbial commons will be essential to overcoming these challenges. I will also identify opportunities for champions of the microbial commons to engage in ongoing international policy-making processes in pursuit of the necessary policy support. Jerome Reichman already highlighted a number of the most essential components of the microbial commons. Among other things, he stressed the importance of establishing, up-front, access and benefit-sharing terms that are reflected in a single, standardized material transfer agreement that would accompany all transfers of materials in the commons. This is an essential aspect of the commons that would contribute to lowering transaction costs associated with using microbial genetic resources in agricultural research. Furthermore, the benefit sharing terms that are ultimately agreed- upon could encourage would-be depositors to overcome reservations they may have about depositing materials in publically-accessible culture collections. My presentation addresses access and benefit sharing related issues that will need to be resolved before it is reasonable to expect wide-spread adoption and use of such a standardized Materials Transfer Agreement (MTA) in the context of the microbial commons. 72 Presentation slides available at http://sites.nationalacademies.org/xpedio/idcplg?IdcService=GET_FILE&dDocName=PGA_054720&Rev isionSelectionMethod=Latest. 191

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The microbial commons will need to encompass both genetic resources in culture collections, and materials “in the field” that have never been collected (much less identified). Today, I will focus primarily on materials in collections. Partly because shortness of time limits my ability to focus on all aspects of the microbial commons, and because the culture collections are already so wide-spread and functioning as essential elements of nationally and internationally supported research and development systems. They will clearly play a key role in the commons, authenticating, maintaining and distributing strains. There are approximately 550 culture collections listed under the World Data Center for Micro-organisms, most of them hosted by public and semi-public organizations and universities. They hold approximately 1.5 million strains. Each year, these listed collections distribute approximately 500,000 isolates. Tom Dedeurwaerdere estimates that a considerably higher number of isolates are exchanged each year informally, without legal agreements, as part of informal networks through peer-to-peer exchanges. Tom has also estimated, based on a survey of a number of genebanks, that approximately 50 percent of the materials in culture collections were acquired by those collections prior to 1993, the year the Convention on Biological Diversity came into force. The year 1993 and the coming into force of the CBD is a very significant date to bear in mind when thinking about promoting a microbial commons, especially when thinking about the status or role of material in microbial collections. Stated bluntly, a culture collection (or a country hosting a culture collection) is free to determine what it wants to do with microbial genetic resources it has acquired from other countries prior to the CBD being implemented in those countries. It can decide to adopt and use an MTA like that described this morning by Jerome Reichman when distributing microbial genetic resources, and in so doing, voluntarily subscribe to the “rules of the game” for the microbial commons. The fact that collections have the possibility treating up to 50 percent of the materials they hold in this way is good news for the microbial commons; it provides a substantial basis upon which to found the commons. The situation is very different for materials acquired after the CBD came into force (and after it has been implemented by countries). The practical consequence of the implementation of the CBD’s Article 15 is that since 1993—assuming countries have implemented the CBD—acquiring new genetic material requires first getting prior informed consent on mutually agreed-upon terms from competent authorities in the countries of origin of that material. If prior informed consent from the competent national authority is not obtained, the collector of the culture collection cannot take the material out of the country. Nor can a research scientist voluntarily deposit such material in a collection outside the country concerned without the requisite permission. Consider the implications of this with respect to materials acquired by culture collections between 1993 and the present. The culture collections concerned would have to have the prior informed consent from the competent authority of the country of origin to distribute such material using the microbial commons-inspired MTA. Unless it was mutually agreed when the material was deposited that that the culture collection had the right to later change the MTA it uses to distribute material, the collection would have to go back to the competent authority from the depositing country to obtain permission to use the new instrument. As far as future acquisitions by culture collections are concerned, it will be necessary to obtain prior informed consent from competent authorities in the countries of origin of microbial genetic resources to redistribute those resources using the commons- 192

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inspired MTA. This is a particularly important consideration given that 99 percent of microbial diversity currently exists in in-situ conditions behind national borders. Over time, to maintain its relevance, an increasing proportion of the material in the microbial commons will have to be materials accessed after 1993, from in-situ conditions. Before proceeding further, I would like to comment on a closely related issue. There seems to be confusion in some of the literature written about the microbial commons concerning CBD-related obligations. Some commentators appear to suggest that a culture collection could extinguish its prior informed consent-related obligations by voluntarily including benefit sharing conditions, in an MTA, that promise to share a percentage of royalties to the country of origin, in the event of commercial exploitation of the resources. While such a clause might well be appreciated by the country of origin, it does not satisfy CBD standards. The CBD is clear that the country of origin has to consent to access for any purpose, whether it is commercial or not. A newcomer to the field could be forgiven for thinking that these obligations rooted in the CBD should not create significant impediments for microbial genetic resources continuing to flow into the microbial commons, and that the pre-1993/post- 1993 divide could be bridged in ways that made it attractive for depositors to proactively place new microbial genetic diversity in the commons. However, the evidence that has been slowly accumulating since the mid-1990s reveals that providers have in fact become increasingly reluctant to make new genetic diversity available to the agricultural research community, and that this reluctance is fueled in part by access and benefit sharing issues. The combined effects of a) high levels of geo-politicized controversy about access and benefit sharing equity, and b) low levels of legal certainty about the conditions under which national authorities can provide access, has contributed to significantly increased transaction costs for research that requires access to agricultural genetic resources, with research having to be terminated or not started, in some cases. To illustrate this phenomenon, I will focus for a moment on the experiences of the CGIAR centers and their efforts to attract new deposits of plant genetic resources to international crop and forage collections which they host. Those collections were originally assembled over the 1970s and 1980s. The centers hold the collections “in trust” for the international community, which means that they agree to maintain and distribute materials for agricultural research and breeding purposes to anyone who requests samples, anywhere in the world. Cumulatively, there are approximately 650,000 accessions of plant genetic crop and forage genetic resources in those collections. Rates of global acquisition and distribution of materials to and from those collections were relatively stable until the mid 1990s, after which time countries have been increasingly unwilling to deposit new materials. Between about 1995 and 2004, the rates of new deposits dropped approximately 80 percent. Part of the reason was the legal and political insecurities about access and benefit sharing associated with the CBD. I want to share a few illustrative examples of how this plays out “in the field”. The CGIAR centers have encountered situations where it was not clear who within the countries-concerned has authority to give prior informed consent to provide access to genetic resources. In light of that uncertainty, no one was willing to take responsibility for agreeing to deposit new material into the Centers’ international collections. If a genetic resource turns out to lead to a commercial success, no one wants to have been responsible for having agreed to make it globally available through the Centers’ genebank—At least not without well defined legal authority to fall back on in their own defense. The problem is, most countries that ratified the CBD still have not 193

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managed to put access and benefit sharing laws in place. And even the countries that have implemented national laws still do not have all the supportive mechanisms in place to make the laws actually work. In numerous such cases, technical level partners in national agricultural research programs have clearly expressed an appreciation for the importance of conserving and making such materials from their country available for research through the international collections concerned. However, they were unable to “get to the end” of the consent- granting processes in their own countries, and the resources were ultimately not made available after extremely long delays. In one instance when Bioversity wanted to coordinate collecting of papaya with a national research organization, we were informed that according to national law, it was necessary to get prior informed consent from local communities. Unfortunately, the national government said it did not know who we should contact in those communities to get prior informed consent. Instead, we were advised that we should contact the communities ourselves and establish to establish who had the right to provide or withhold approval and then inform the competent national authority. In light of the likely complications we did not purse the related collection and research project. Repeated experiences of this nature lead some of the CGIAR Centers to adopt informal policies to stop approaching governments with proposals to organize new collecting missions. It was too complicated, the transaction costs were too high, and the negotiations attracted too much negative political attention. Instead, the centers put their hopes in the idea that the International Treaty on Plant Genetic Resources for Food and Agriculture—the treaty Shakeel Bhatti73 described this morning—would provide a response to their access and benefit sharing related challenges. In the meantime, the end result has been a gradual tapering-off of the levels of new plant genetic diversity that is being made available to the plant research and breeding community through the international public genenbanks. I have been focusing on how access and benefit sharing-related challenges have created disincentives for potential providers of plant genetic resources to make new diversity available. The situation appears to be similar with respect to microbial genetic resources for food and agriculture. This morning, Flora Katz74 highlighted the difficulties associated with making arrangements to get access to microbial resources in a post-CBD world, stating that it takes an average of two years to get access to materials for the project she has been working on. Others have shared similar accounts. 75 In this context, it is interesting to revisit the statistic mentioned earlier this today that up to approximately 60 percent of the isolates that are transferred are transferred informally. Why? Presumably one of the incentives for continuing to use informal mechanisms is that the formal procedures are considered to be too onerous with too high transaction costs. What would happen to those exchanges if the transferors opted to bring those exchanges to the attention of relevant competent national authorities of the countries of origin of the materials for case-by-case adjudication? Presumably, the speed and volume 73 See Chapter 19 within this publication. 74 See Chapter 18, Proposal for a Microbial Semi-Commons: Perspectives from the International Cooperative Biodiversity Groups, Flora Katz, Fogarty International Center, National Institutes of Health, within this document. 75 See Chapter 24. Microbial Commons: Overview of the Governance Considerations—A Framework for Discussion Tom Dedeurwaerdere, Université Catholique de Louvain, Belgium, within this publication. 194

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of those exchanges would be negatively affected, possibly brought to a halt. At the same time, it is clearly unacceptable that exchanges that should be subject to formal legal approval are continuing “under the radar”. Ultimately, the scene appears to be set for considerably more controversy, with negative impacts on the management and volume of material included in the hoped-for microbial commons. What options exist to address the increasing reluctance of would-be depositors to make more microbial genetic resources publicly available, and in particular to make them available using a standardized MTA that reflects the basic tenets of the microbial commons? How is it possible to bridge the “1993 CBD divide,” so that the commons is not limited to materials in culture collections acquired before 1993? It seems to me that one of the potentially most effective means to address these challenges in effective, long- lasting way is for national governments to meet in international, intergovernmental fora to create internationally harmonized standards, mechanisms and tools to support the collective pooling and management of microbial genetic resources. Intergovernmental action and support could come in number of different forms. Perhaps the highest-level form of intergovernmental intervention would be to agree to a system whereby governments would agree to a tax on commercial sales of microbial genetic resources products, the sum total of which would be directed to an international benefit sharing fund. In return, all countries who are part of the agreement would provide facilitated access to one another, upon request for microbial genetic resources. This was a model of horizontally constructed multilateral access and benefit sharing that many people once hoped-for in the early stages of the seven year negotiations of the International Treaty on Plant Genetic Resources for Food and Agriculture. It quickly became apparent that many countries would not go along with such an approach. However, with 20 years of experience now under the CBD as proof of the inherent difficulties of making bilaterally oriented ABS systems to work, perhaps the international community could possibly consider such an approach again, this time focusing on microbial genetic resources for food and agriculture. Quite frankly, to me, it still seems like an unlikely scenario, no matter how practical it may be, given many developed countries’ aversion to such schemes. Another, equally high-level form of intergovernmental intervention would be the creation a new legally binding international treaty on microbial genetic resources, establishing standard conditions for access and benefit sharing, a standard material transfer agreement, a common information-sharing platform, reporting schedules, tracking mechanisms, etc. All participating organizations and individuals in contracting parties would use the MTA adopted under the treaty. This is clearly an approach inspired by, and similar to, the International Treaty on Plant Genetic Resources for Food and Agriculture, but focused on microbial genetic resources. Obviously, a treaty of this nature would have the benefit of creating legal certainty and would, presumably, create the possibility of high- levels of political level buy-in and commitment. It could also—like the International Treaty on PGRFA—bridge the “1993 CBD divide” in a very interesting way. The International Treaty states that PGRFA that are “in the management and control” of state parties “and in the public domain” are automatically included in the Treaty’s multilateral system of access and benefit sharing, regardless of when they were collected. Even though the Treaty negotiators initial mandate was to consider access and benefit sharing conditions for ex-situ collections collected before the coming into force of 195

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the CBD, they developed this formula that bridges the “1993 CBD divide” very artfully. However, negotiating such a treaty, and putting in place the supporting mechanisms and processes for its implementation is an extremely process-heavy, time-consuming procedure. Other, less resource-demanding mechanisms are to be preferred, if they can be effective. One such possibility would be for an intergovernmental body to develop generic agreements that could be entered into, on a voluntary basis, between culture collections (or the governments of the countries in which the collections are located) and an intergovernmental body. Those agreements would reflect the main characteristics of the microbial commons, for example, establishing that that culture collections would hold and make materials available for purposes X, Y or Z, the conditions under which materials held by the culture collections would be distributed, how benefits derived from commercial use will be shared, the MTA to be used for distributing materials, where information about materials could be publicly posted and shared, and so on. Indeed this was the approach taken by the FAO Commission on Plant Genetic Resources for Food and Agriculture of the Food in its efforts, from the mid 1980s to the mid 1990s, to develop the “international network of ex-situ collections of plant genetic resources.” The commission developed model agreements that could be signed by organizations hosting PGRFA collections and or the country where those collections were located. In the end, this approach to developing an international PGRFA commons was overtaken by the negotiations of the International Treaty on Plant Genetic Resources for Food and Agriculture. However, the enterprise did show some promise. In 1992, before efforts to develop the system were halted, nearly 30 countries indicated that they would sign such agreements to make their national collections available. This incremental-federated approach has the advantage of being lighter weight (at least potentially) than a full blown treaty. Most important, the genetic agreements and related MTA would be very useful tools in the hand of national champions of an international microbial commons, allowing them to present hesitant national competent authorities with concrete, constructive options for how to administer their access and benefit sharing responsibilities. At least for an important subset of the countries genetic resources, the fact that the general policy approach (in support of international harmonized standards for pooling and facilitated access and benefit sharing) and MTA have been endorsed by an intergovernmental forum in which the competent authority’s own government has participated will give the option added credibility. Such an initiative could complement, and build upon, the kind of coordination that has been promoted to date by the World Federation of Culture Collections, albeit without formal intergovernmental support and without all of the commons-related focus that is the subject of this meeting, for example. The downside of this incremental federated approach is that it could potentially take a long time for a critical mass of collections and or competent national authorities to voluntarily decide to sign such agreements. So it could be a while before there is a significant amount of microbial genetic resources pooled and available under standardized terms and conditions. Another potential downside is that the approach is largely geared towards collections, and not so appropriate for in-situ materials. 196

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Another, still lighter-weight approach which nonetheless exploits some of the goodwill that can potentially be purchased by engaging intergovernmental bodies would be to develop non-legally binding guidelines or codes of conduct. Such codes or guidelines could recommend following commons-informed principles and approaches, and recognize the advantage of terms and conditions that encourage the common pooling of microbial genetic resources and adopting low-transaction approaches to access and benefit-sharing. They could go so far as including model MTAs and recommending their use under various circumstances, by certain classes of users. Again, such guidelines or codes would be useful tools in the hands of champions of a microbial commons. As instruments endorsed by an intergovernmental body, they could help to move competent national authorities in the direction of participating in the microbial commons. The very light-weight form of intervention by an intergovernmental body would be some form of endorsement of the projects that subscribe to microbial commons principles, and that are dedicated to expanding the coverage of voluntarily adhered to practices by natural and legal persons. Such project could be presented to the next meeting of the CBD or the Commission on Genetic Resources for Food and Agriculture, and those bodies could make explicit statement recognizing the value of such projects and their objectives. One advantage common to all of these ways of engaging intergovernmental fora is that they stimulate discussion at a very high policy level, with the potential to lift individual organizations and competent authorities above their national contexts, allowing them to investigate more broadly-conceived options for using and conserving their genetic resources. Intergovernmental processes would facilitate national competent authorities and other stakeholders to engage with their peers from other countries in a constructive, goal oriented context, setting the stage for the pursuit of common objectives through means that transcend purely national competencies. As it turns out, there are currently opportunities for engaging in such internationally sponsored discussions and for promoting ABS norms supportive of the microbial commons in at least two ongoing intergovernmental policy-making processes. One of these processes is the ongoing negotiation, under the aegis of the CBD, of an international regime on access and benefit sharing. These negotiations have been ongoing since 2004, and there has been little substantive progress. As one way of moving forward, a growing number of delegations are advocating sectoral approaches to the development of ABS norms under the international regime. Since there is no time to actually work out what the appropriate norms would be for each sector, the international regime would create flexibility, or even create a mandate, for considering such norms sometime in the future, after the framework of the regime is adopted. To date, however, there has been practically no discussion at these negotiating meetings of what sectors might deserve special rules or what those rules may look like. The CGIAR centers are organizing a side-event at the next negotiating meeting (in November in Montreal) to sharing information with delegates about the (food security and economic development) benefits to be gained through internationally coordinated strategies to pool and use microbial genetic resources in support of agriculture research and development. We will also highlight possible options related to access and benefit sharing that the delegates could advance to support the microbial commons, in the course of the negotiations of the regime. 197

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Another intergovernmental forum that is currently open to technical inputs concerning access and benefit sharing issues is the Commission on Genetic Plant Resources for Food and Agriculture. The commission adopted a multiyear plan of work in 2007 which includes examination of “policies and arrangements for access and benefit sharing for genetic resources for food and agriculture”. The Commission secretariat is supporting the development of a study of on the use and exchange of microbial genetic resources, and another on the impact of climate change on countries’ interdependence on microbial genetic resources. These studies are intended to inform the discussion at the Commission level of what might be appropriate ways of regulating access to microbial genetic resources used for food and agriculture. Similarly, the Commission has a scoping study on microbial organisms and invertebrates as an input into its upcoming session. Then two or four years later, the Commission will review key issues related to microorganisms and invertebrates used in food and agriculture. This is all fairly new—until very recently, the Commission has generally focused almost exclusively on plant genetic resources, and more recently on animal genetic resources. The fact that the Commission is widening its scope of enquiry, and possibly norm-setting, represents potentially rich opportunities for introducing consideration of access and benefit sharing norms to support the microbial commons. To summarize, I have argued that access and benefit sharing related challenges have the potential to undermine the development of a vibrant and active international microbial commons. Intergovernmental participation in the development of access and benefit sharing norms (and related instruments) will be essential to overcome these challenges. There are currently opportunities in ongoing international policy-making processes to introduce consideration of access and benefit sharing norms that would support the microbial commons. Question and Answer Session PARTICIPANT: I take it that you read the convention as definitively eliminating the problem of pre-1993 claims, because the contrary reading would be the International Declaration on Sovereignty over Natural Resources of 1967. Are you confident that it is actually decided, or is it just there for future argument? The second thing is more important. I take it that your third category would be analogous to the soft law approach that preceded the treaty that Shakeel Bhatti talked about—that it grew out of the soft law approach. I would hope that one would try to make it more successful than the preceding soft law approach, although you could say that it succeeded in the treaty. Is that where you are going—that it was a true soft law approach on which you could act? MR. HALEWOOD: Yes. I think that the soft law approach could potentially work better now than it did before—partly because the International Treaty on Plant Genetic Resources for Food and Agriculture now exists. And partly because, in the context of the ongoing negotiations of the CBD’s international regime, there are potential opportunities now for quick adoption of soft laws so that that the international community can demonstrate it is making some progress. Perhaps these options will look increasingly attractive the slower things go. 198

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PARTICIPANT: So, you are implying that they might find that attractive in order to avoid another seven-year negotiation and just profit from work already done? MR. HALEWOOD: I am not sure. It is possible that some of the steam is coming out of the geopoliticization of the access and benefit-sharing of genetic resources. When you see the way Brazil, China, and India are conducting themselves in the negations of the International Regime, it may be that there is room now for a less geopoliticized discussion and more open consideration of some of these soft-law possibilities. 199

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