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Info Service on Biodiversity and Traditional Knowledge (Jul23/01) 9 July 2023 (Third World Network*) – The Ad Hoc Open Ended Working Group to Enhance the functioning of the Multilateral System of Access and Benefit Sharing under the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) resumes its work after several years. The first formal meeting after the deadlock at the Treaty’s 8th session of the Governing Body (GB8) in 2019 is going to take place at the headquarters of the Food and Agriculture Organization (FAO) in Rome on 12 to 14 July 2023. This will be the 10th meeting of the Working Group. Resolution 03/2022 of GB9 held last year in New Delhi, India, had renewed the mandate of the Working Group to finalize the enhancement of the functioning of the Multilateral System (MLS) by GB11 in 2025. The ITPGRFA was adopted in 2001 with the objectives: (i) conservation and sustainable use of plant genetic resources for food and agriculture (PGRFA) and (ii) fair and equitable sharing of benefits from the use of, such resources, in harmony with the Convention on Biological Diversity, for sustainable agriculture and food security. The crops covered by the Treaty is listed in Annex 1. It entered into force in 2004 and also known as the “Seed Treaty”. The MLS was established under Article 10 of the ITPGRFA to facilitate access to PGRFA for plant breeders, scientists, and various other users and stakeholders including intermediaries as well as for fair and equitable sharing of monetary and non-monetary benefits arising from the utilisation of PGRFA. Access and benefit sharing under the treaty are intrinsically linked. The system deals with PGRFA of the crops listed in the Annex 1 including those under the management and control of the Contracting Parties (States) and those held in the ex situ collections of the International Agricultural Research Centres of the Consultative Group on International Agricultural Research (CGIAR) or other international institutions as provided in Article 15. The MLS does not legally include PGRFA that are held by natural and legal persons within the jurisdiction of Contracting Parties. The Parties have however committed to encourage such persons to include such PGRFA to the MLS and take appropriate actions in this regard. Facilitated access to PGRFA is to be provided to other Contracting Parties and their natural and legal persons through the use of a Standard Material Transfer Agreement (SMTA) which provides legal certainty to fair and equitable benefit sharing. The recipient of the PGRFA shall further require the conditions of the SMTA to apply to any subsequent transfers of the resource. As of 2022, the total number of samples available in the MLS increased to 2,343,549 while Data Store reports around 90,690 SMTAs from providers located in 56 countries, distributing material to recipients based in 181 countries. There are very limited records of monetary and non-monetary benefits actually shared under the MLS, except for the Treaty’s self-professed benefit of the facilitated access to PGRFA materials under Article 13. The Benefit Sharing Fund created under the treaty continues to depend on voluntary funds. This means the developing countries are still waiting for fair, equitable and predictable benefit sharing, while the access to seeds for the corporate seed sector expands. It is in this regard that enhancement of the MLS was undertaken. Resolution 3/2022 of GB9 states that the Contracting Parties to ITPGRFA commit to the following shared aims:
The Resolution mandated the Working Group to meet at least once before GB10 in 2023 and to provide a checkpoint report on progress of the work on the MLS enhancement and regarding the continuation of the process. This paved the way for the meeting of the Working Group to be held on 12-14 July. The Working Group Co-Chairs have circulated a document called Co-Chairs’ Proposal on Enhancing the Functioning of The Multilateral System (IT/OWG-EFMLS-10/23/4). The document states, “The Co-Chairs will present their checkpoint report to the Tenth Session of the Governing Body, which would include the Co-Chairs’ proposal and consider discussions of the Working Group at this meeting, observations on progress during this biennium and recommendations for the Governing Body’s consideration.” The Co-Chairs’ proposal contains four parts: overall objective and starting point (section 1), general reflection of progress and organisation of upcoming work (section 2), the “June 2019 draft package” as a possible starting point (section 3) and, the proposals for way forward (section 4). The proposal takes note of general willingness and strong commitment by all regions and stakeholder groups to resume the negotiation process in a constructive manner. Taking cue from the 2019 discussions, the proposal identifies three major areas that require early attention: (a) digital sequence information (DSI) / genetic sequence data, (b) an expansion of the Treaty coverage (Annex I), and (c) the sharing of benefits (including non-monetary). It also records a general recognition that the key measures needed to achieve the enhancement of the MLS are interlinked and interdependent. Although the Co-Chairs’ proposal tries to best reflect currently acceptable language on all the three key issues, it is unfortunate that discussions on the way forward on certain issues that are of priority to the developing countries, i.e., DSI and sharing of benefits, are largely process-oriented. While the Co-Chairs’ proposal addresses how to arrive at a solution for the issues relating to DSI and sharing of benefits, with regard to expansion of the Annex 1 crop list, the proposal actually advances a solution and discusses the process to implement the said solution. Digital Sequence Information (DSI) A major concern in 2019 relating to the benefits arising from the use of DSI seems to have been resolved with the decision of the 15th Conference of Parties (COP15) of the Convention on Biological Diversity (CBD) in December 2022. In this decision CBD Parties agreed to share benefits arising from the utilisation of DSI in a fair and equitable manner. The Co-Chairs’ proposal duly took note of this. However, it is interesting to see that there is not much on the substance of a possible DSI solution. It simply suggests moving forward in developing a solution on DSI for the MLS. Although the proposal does not indicate that a decision will be tied to the progress of CBD negotiations, it recommends looking into the COP15 decision for adopting features or elements while designing the solution in the MLS. Some of elements or features identified in the COP15 decision that are in the Co-Chairs’ proposal are to (i) be practical, (ii) generate more benefits than costs, and (iii) not hinder research and innovation among, other criteria found in the decision. It must be noted these criteria in the COP15 decision have also been criticised. The issue before the ITPGRFA Working Group is quite different from the issue in the CBD. The CBD has to set the generic rules relating to genetic resources and the benefits arising from the utilization of such resources. The Nagoya Protocol on access and benefit sharing of the CBD does not generate a comparable system for “sharing” genetic resources and benefits. It sets up generic rules or a framework for Parties to provide appropriate access to genetic resources, while protecting the sovereignty of Parties over their genetic resources, and also to ensure fair and equitable benefit sharing through appropriate technology transfer, capacity building and sharing of (non-)monetary gains. The CBD solution on DSI therefore has to address several issues such as challenges created by the use of DSI and synthetic biology vis-à-vis the exercise of sovereignty over the genetic resources concerned. This has led to extensive discussions relating to prior informed consent (PIC) and mutually agreed terms (MAT) in CBD negotiations. Even though a click-wrap agreement on data use could easily ensure PIC and MAT on reasonable terms, it is convenient for developed countries to represent such elements as requiring individual negotiations and conclusions of agreements, because the Nagoya Protocol provides for generic rules for ABS rather than creating a MLS. This exaggerated complexity (propagated by developed countries) is then projected as a hindrance to research and innovation in the CBD and Nagoya Protocol and could lead to impasse in the negotiations at the CBD. The case with ITPGRFA is different. The Treaty has already created a “multilateral system” that would facilitate access to PGRFA, reducing the challenges associated with PIC and MAT. Inclusion of DSI into the SMTA of the MLS or incorporation of an additional data use agreement consistent with objectives and purposes of the SMTA by databases providing access to PGRFA DSI could address the benefit sharing challenges in this sphere. This would leverage the Treaty’s MLS in a way that would keep genetic resources publicly accessible and prevent the need for individualised PIC and MAT, while preserving benefit sharing obligations. Both developed and developing countries have an interest in the enhancement of the MLS of the Treaty. Developed country Parties are looking for more PGRFA to be accessed through expansion of crops covered by the MLS while developing countries are looking towards an increase in both monetary and non-monetary benefits, and a functioning MLS system before the expansion of the Annex 1 crop list. A solution to challenges created by DSI, therefore, could be linked for both groups of countries. The Co-Chair’s proposal duly recognizes this and agrees that a solution to DSI and other issues are interlinked. The question, nevertheless, that remains is how to maximise legal certainty for the sharing of benefits arising from the use of DSI under the MLS. This is an important criterion identified both in the COP15 decision as well as Resolution 3/2022 of GB9. Sharing of Benefits Two of the most important goals of the enhancement of MLS processes are to (i) increase the benefits that arise from the Multilateral System for all Contracting Parties and users, both monetary and non-monetary, and (i) increase user-based income to the Benefit-sharing Fund in a sustainable and predictable long-term manner. Interestingly under the way forward section, the Co-Chairs address only the second goal. There again it falls short of substantive content. Despite several positive remarks on the subscription system and considering the 2019 package as a starting point in other parts of the proposal, the way forward section does not refer to the systems that were proposed in the 2019 draft package i.e. the subscription system or the single access system. Instead, it focuses on payment structure and rates, but only to say “that discussion on payment structure and rate will also benefit from information on progress in the work of the Standing Committee on the Funding Strategy and Resource Mobilization regarding a funding target for the Benefit-sharing Fund”. Additionally, the Co-Chairs’ propose to re-consider the question whether the Working Group wants to discuss the possible role of Contracting Party contributions to complement payments by users of the MLS. Although this would be of interest to industry or commercial users, undertakings from governments to pay for MLS accessions would not be of much use for developing countries, especially if they are also required to make payments. Making Parties contribute to fund in lieu of user-based payments has the problem of socializing the burden and privatizing the profits. Parties already contribute to the fund today on a voluntary basis and in all probability, they will continue to do so, but mandating these kinds of payments is not a solution to the existing problem. This shows that there is little substantive content that has been incorporated into the solution, especially with regard to the interests of developing countries. This is not the case with the major developed country interest, i.e. expansion of the list of crops in Annex 1. Expansion of the List of Crops in Annex 1 One of the major interests of the developed countries in the enhancement of the MLS is the expansion of crop diversity under Annex 1 of the Treaty. This was part of the 2019 draft package. However, every Party was given a chance to exclude certain and a limited number of species native to its territory and/or landraces/farmers’ varieties generated and used in their territories that it will not make available under the terms and conditions of the MLS. The Co-Chairs’ proposal provides more concrete substantive content in this regard. It reads: “Rather than through the safeguards included in the 2019 draft package, this could be realized, for instance, by amending the International Treaty to include, in-principle, all PGRFA in the Multilateral System. The practical implementation could then be by giving the Governing Body flexibility to agree on priority crops to be progressively included in a list. Contracting Parties could also, alternatively, have flexibility to gradually implement the expansion at national level.” The Co-Chairs then propose that the needs and interests of the various stakeholders will inform the setting up of the priority crop list. They identify examples of criteria for identifying crops in the priority list such as interdependence (crops with the highest level of interdependence of countries in the world), and use (crops with the highest degree of use for nutrition or climate resilient production). Once such a list is drawn up progressively, flexibility can also be given to Parties to implement facilitated access gradually. The proposal further says the enhancement solution could be accompanied by language in a Resolution setting a common goal or vision by the Governing Body to have, for example by 2050, a Multilateral System containing well curated, fully characterised and described genetic resources of as broad a list of food and forage crops as possible. However, the question is whether there should be an upfront commitment to expand Annex 1 to the fullest extent possible, or whether the expansion should be contingent on the enhanced performance of the MLS. What is missing in the Co-Chairs’ proposal is the need to review the enhanced functioning of the MLS before full expansion of Annex 1, or the link between the periodic review of the functioning of the MLS’s benefit sharing aspects and the gradual expansion of Annex 1 crops. Intellectual Property and Accountability of Databases: Elephants in the Room? Two important issues that still seem to be a bit far from the canvas of the Working Group’s work as described in the Co-Chairs’ proposal relate to intellectual property rights and accountability of databases. The MLS currently could be misused to screen the accessed plants and to claim patents on native traits, which are linked, in the patent claims, to specific naturally occurring gene sequences, single nucleotide polymorphism (SNPs) or quantitative trait loci (QTLs). In recent years, the non-governmental network No-Patents-on-Seeds has reported a flood of such patent applications and grants. Classic is the case of a patent on insect-resistant peppers, which was recently confirmed. This is against Article 12.3(d) of the ITPGRFA that reads: “Recipients shall not claim any intellectual 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”. The very same provision is also used in the SMTA signed by users of the MLS. On the specific case of insect-resistant peppers, the Dutch Gene Bank (CGN) issued a note concerning patents on native traits which says : “The interpretation of the claims mentioned above [patents on native traits and on traits linked to a specific gene sequence] may be that the patents cover all use of the genes encoding for the traits described. These genes have been identified in and occur in CGN accessions. As a result, in such interpretation, enforcement of a patent such as mentioned above may be in conflict with the obligations of a recipient if that recipient has accepted the terms and conditions of the SMTA in order to obtain the accession.” These issues can be rectified, for example, if the meaning or scope of Article 12.3(d) of the Treaty, which is also used as an SMTA provision, is clarified, including its application for the use of DSI. Furthermore, the users of the system should be obliged (through the SMTA) to disclose the exact genetic resources used in patent applications. This is the only way to check whether this obligation under the SMTA is fulfilled. It must be noted that intellectual property such as patents and trade secrets are major barriers in facilitating access to genetic resources for plant breeding, which is one of the most important goals of the ITPGRFA. However, the Co-Chairs’ proposal currently does not take into account this crucial issue. This is the same omission in the case of the accountability of databases. The current practices of databases that share DSI of PGRFA materials do not undertake any responsibility to ensure that the uploaders of the DSI into the database have the legitimate authority to do so. They also do not require the users or downloaders of such data to enter into any sort of benefit sharing agreement with the MLS or providers of the DSI. Some of them even allow anonymous usage of the DSI which helps industry and other commercial users to bypass the benefit sharing obligations. Such anonymous users do not only raise concerns about benefit sharing but also cyber-biosecurity. They are not under any obligation to report any usage data of PGRFA DSI to the MLS. One of the logical solutions to the challenges of use of DSI is to ensure proper data governance over activities involving DSI, such as generation of DSI, its storage, providing for access to DSI, rules for cross-border transfer of DSI, processing of DSI, termination or deletion of DSI as well as reporting of the usage to the MLS. This could be achieved through a legal obligation to channel sharing of the DSI of PGRFA through recognized databases which are accountable to the Treaty and its Contracting Parties. Unfortunately, this issue also finds no space in the Co-Chairs’ proposal.+ * With input from Francois Meienberg (ProSpecieRara, Switzerland).
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