International Treaties on Plant Genetic Resources

1. Seminar Conservation and Protection of Local Plants 20 th October, 2015 Plant Health DirectorateInternational Treaties on Plant Genetic Resources Mr. Clifford Borg Principal Scientific Officer - Plant Health Directorate

2. 1 - Introduction • International Treaty for Plant Genetic Resources for Food and Agriculture - ITPGRFA • Nagoya protocol • Access to Benefit Sharing Regulation – CION Regulation. • Global Plan of Action for Plant Genetic Resources.

3. International Treaty for Plant Genetic Resources. • Recognizing the enormous contribution of farmers to the diversity of crops that feed the world. • Establishing a global system to provide farmers, plant breeders and scientists with access to plant genetic materials. • Ensuring that recipients share benefits they derive from the use of these genetic materials.

4. 2.1 - Main Provisions: 2.2 - Multilateral system The Treaty’s truly innovative solution to access and benefit sharing, the Multilateral System, puts 64 of our most important crops – crops that together account for 80 percent of the food we derive from plants – into an easily accessible global pool of genetic resources that is freely available to potential users in the Treaty’s ratifying nations for some uses.

5. 2.3 - Access and benefit sharing The Treaty facilitates access to the genetic materials of the 64 crops in the Multilateral System for research, breeding and training for food and agriculture. Those who access the materials must be from the Treaty’s ratifying nations and they must agree to use the materials totally for research, breeding and training for food and agriculture. The Treaty prevents the recipients of genetic resources from claiming intellectual property rights over those resources in the form in which they received them, and ensures that access to genetic resources already protected by international property rights is consistent with international and national laws. Those who access genetic materials through the Multilateral System agree to share any benefits from their use through four benefit-sharing mechanisms established by the Treaty.

6. 2.4 - Farmers’ rights The Treaty recognizes the enormous contribution farmers have made to the ongoing development of the world’s wealth of plant genetic resources. It calls for protecting the traditional knowledge of these farmers, increasing their participation in national decision-making processes and ensuring that they share in the benefits from the use of these resources.

7. 2.5 - Sustainable use Most of the world’s food comes from four main crops – rice, wheat, maize and potatoes. However, local crops, not among the main four, are a major food source for hundreds of millions of people and have potential to provide nutrition to countless others. The Treaty helps maximize the use and breeding of all crops and promotes development and maintenance of diverse farming systems.

8. 2.7 - Discussion Plant genetic resources are essential to a sustainable agriculture and food security. FAO estimates humans have used some 10 000 species for food throughout history. However, only about 120 cultivated species provide around 90% of food requirements and 4 species (Maize, Wheat, Rice and Potatoes) provide about 60% of human dietary energy for the world's population. Of the myriad of varieties of these crops developed by farmers over millennia, which form an important part of agricultural biodiversity, more than 75% have been lost in the past 100 years.

9. 3 - Background – NAGOYA PROTOCOL The Nagoya Protocol to the Convention on Biological Diversity on "Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization" implements the third objective of the Convention on Biological Diversity, namely the fair and equitable sharing of benefits arising from the utilisation of genetic resources.The Nagoya Protocol aims at establishing a clear and transparent legally binding framework in determining how researchers and companies who utilise genetic resources and traditional knowledge associated with genetic resources would obtain access and how future benefits arising from such utilisation would be shared. In particular, it details information that needs to be included in the prior informed consent (PIC) and provides a general obligation on the establishment of a benefit sharing agreement to be established through mutually agree terms. Under this Protocol, measures shall be taken to ensure that users respect the access and benefit sharing measures of the country providing the genetic resources and associated traditional knowledge, including the respect for indigenous and local communities’ rights over both. The related EU Regulation No 511/2014, which came into force on the 12 October 2014, provides a framework for the actions of users of genetic resources and traditional knowledge associated with genetic resources within the Union. Through this Regulation, all users would have to exercise 'due diligence' to ascertain that the genetic resources and the associated traditional knowledge have been accessed in accordance with the applicable legal requirements.

10. 4 - EU – ABS REGULATION The Regulation applies to genetic resources over which States exercise sovereign rights. This reflects a key principle of the CBD enshrined in 15(1) of the Convention and reaffirmed in Article 6(1) of the Protocol, which recognises that States have the authority to determine access to genetic resources. It implies that the Regulation does not apply to genetic resources obtained from areas beyond national jurisdiction. Utilisation of genetic resources is defined in the Regulation, exactly as in the Protocol, as “to conduct research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology, as defined in Article 2 of the Convention” (Article 3(5) of the Regulation). A user is defined in the Regulation as any natural or legal person who utilises genetic resources or associated traditional knowledge (Article 3(4) of the Regulation). This is independent of the users’ size or of the intent of the use. Thus the due diligence obligation applies to individuals, including researchers, small and medium sized enterprises and multinational companies. The core obligation on users under the Regulation is to exercise due diligence to ascertain that the genetic resources which they utilise have been accessed in accordance with applicable access and benefit-sharing legislation or regulatory requirements and that benefits are fairly and equitably shared upon mutually agreed terms, in accordance with any applicable legislation or regulatory requirements Article 4(1) of the Regulation). Guidance documents are being prepared, future implementing regulation , new procedural requirements for recognised best practices and register of collections.

11. 5- Questions and answers on access and benefit-sharing 5.1 - What is ABS? Biodiversity, the variety of life on Earth, is protected by an international convention, the Convention on Biological Diversity (the CBD). The EU and its Member States are Parties to this Convention. One of its basic principles recognizes that States have sovereign rights over the genetic resources found within their national jurisdiction, and that they can set conditions for access to such resources. In line with Article 15 of the CBD, the signatories should do their best to facilitate access to their genetic resources "for environmentally sound uses". The CBD introduced also a concept of benefit-sharing, hence "access and benefit sharing", or ABS. Any benefits that arise from conducting research and development on genetic resources falling under the scope, including R&D which leads to commercial use of the developed product, are to be shared fairly and equitably with the Party providing these resources.

12. 5.2 - What is the Nagoya Protocol and why was it needed? The "Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization to the Convention on Biological Diversity", is a legally binding treaty negotiated and adopted under the auspices of the CBD in Nagoya, Japan in 2010. This Protocol develops the general concepts contained in Article 15 of the Convention (i.e. the ABS provisions) into a fully-fledged operational regime. The entry into force of the CBD did not create sufficient legal certainty. Some provider countries started to act upon the text of Article 15 of CBD and established national access legislation, which in some cases was so strict that users no longer had access to access genetic resources from those states anymore. Many other Parties, such as the Member States of the European Union, while recognizing the general principles of Article 15 of the CBD, did not consider it sufficiently clear to be implemented into national law. This need for a more specific agreement led to the opening of negotiations of an international agreement on the subject. This agreement – the Nagoya Protocol – was finalized and adopted in October 2010 in Nagoya, Japan. The Nagoya Protocol provides specific framework conditions for procedures that govern how users of genetic resources and traditional knowledge associated with genetic resources may obtain access to such resources and traditional knowledge. In particular, it details information that needs to be included in the prior informed consent (PIC) given by the provider country. It also contains a general obligation on the establishment of a benefit sharing agreement to be established through mutually agreed terms between the provider and the user. The Protocol obliges states to ensure that users operating under their jurisdiction respect the legislative or regulatory requirements of states that provide genetic resources and traditional knowledge. In practice, a majority of the agreements concerning the access to genetic resources are expected to be signed between biodiversity-rich (and often developing) countries, and companies using the genetic resources, typically in more advanced countries.

13. 5.3 - Why do we need the ABS Regulation? The EU ABS regulation brings EU law into line with the international obligations agreed at Nagoya. As of when will the new rules apply? The date for the entry into force for the Union of the Nagoya Protocol is 12 October 2014, i.e. the 90th day after deposit of the 50th instrument of ratification, acceptance, approval or accession by the Parties. This is also the date for the entry into application of EU ABS Regulation 511/2014. The rules cover all genetic resources and traditional knowledge associated with genetic resources accessed as of the entry into force of the Protocol for the Union. Some of the key obligations applicable within the EU will only enter into application one year after that date.

14. 5.4 - In which cases do the ABS rules of apply ? The ABS rules apply to the utilization of genetic resources and traditional knowledge associated with genetic resources. Utilization means to conduct research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology. Further interpretation of this term can be expected at the international level with the entry into force of the Nagoya Protocol and the beginning enforcement practice. Genetic resources are being used in research and development for many different purposes. These are some examples: • Identifying active compounds for medicine development: In April 2012, the Danish company LEO obtained FDA-approval for a topical gel against a precursor to skin cancer. The main active ingredient of this gel is derived from the Euphorbia peplus plant found in Australia, after an extraction, purification and crystallization process of about five months. LEO will now seek market approval in other major markets. • • Genetic resources also play a major role in developing nature-based renewable energy to face the energy challenges of a growing world population while ensuring biodiversity and environmental protection and make the transition to a postpetroleum economy. • • Polyurethane-eating fungi discovered in Amazonian rainforest. Researchers have identified plant fungi in the Ecuadorian rainforest that can digest plastic. The discovery hints that there may be a wide range of effective waste-consuming microbes in existence, according to the study, which found that several different fungi, including one called Pestalotiopsismicrospora, can break down the widely used plastic, polyurethane.

15. 5.5 - What will the EU ABS regulation mean in practice for EU users? All users will have to exercise 'due diligence' to ascertain that the genetic resources and the associated traditional knowledge they use have been accessed in accordance with applicable legal requirements and to ensure that, where relevant, benefits are shared. Users will also be obliged to declare at specific check points that the correct procedure has been followed. The due diligence obligation should ensure that the information relevant to ABS is available throughout the whole genetic resources value chain. This will enable all users to know of and respect related rights and obligations. At the same time, the due diligence approach does not prescribe details of the measures to be taken by users, but leaves users some flexibility to take measures that work best for their respective context, and also to develop sectoral best practices.

16. 5.6 - How will the "due diligence" concept work? Users need to seek, keep and transfer to subsequent users' information on:  the date and place of access to genetic resources or traditional knowledge associated with genetic resources;  the description of the genetic resources or traditional knowledge associated with the genetic resources utilized; • the source from which the genetic resources or traditional knowledge associated with genetic resources were directly obtained, as well as subsequent users of genetic resources or traditional knowledge associated with genetic resources;  the presence or absence of rights and obligations relating to access and benefit sharing including rights and obligations regarding subsequent applications and commercialization;  access permits, where applicable; • mutually agreed terms, including benefit-sharing arrangements, where applicable. In addition, a user needs to analyze if the information in his possession is sufficient and be certain that he or she complies with applicable legal requirements in the provider country. Otherwise, users must either obtain the missing information or discontinue utilizing the genetic resources and/or the traditional knowledge associated with genetic resources. Users will be obliged to retain any information relevant for access and benefit-sharing for a 20-year period after the end of the period of use. The EU ABS Regulation foresees that specific choices taken by users on the tools and measures applied for exercising due diligence should be supported through the recognition of best practices as well as complementary measures in support of sectoral codes of conduct, model contractual clauses, and guidelines with a view to increasing legal certainty and reducing costs.

17. 5.7 - Does the EU ABS Regulation contain all ABS measures applicable in the EU? The EU ABS Regulation establishes the rules for the compliance measures, mandatory under the Nagoya Protocol within the EU. However, the Regulation will need to be read in conjunction with the secondary legislation concerning Articles 5, 7 and 8 of the regulation, which is under development, as well as with the further measures that the EU Member States have to take as mandated by the EU ABS Regulation, notably on penalties. Also, Member States' administrative law will contain all the possible measures that competent authorities can take in cases of non-compliance with the EU ABS regulation.

18. 5.8- Are there additional costs and burdens for users? Professional associations (and users) will be best placed to identify the most cost effective ways of implementing the due diligence obligation. The flexibility of the due diligence concept should allow users to tailor due diligence measures to existing best practices, thereby lowering costs. Monitoring costs for users are limited, and declarations will only be made at points where users are already obliged to summarize and evaluate relevant information. Costs should be minimal, as: • Declarations in the context of research funding are already standard practice; • Users already prepare a dossier describing the product for which a permit is sought for product approval or commercialization. Real costs may of course arise in cases where users have not been diligent, and have failed to seek relevant information on ABS when acquiring a genetic resource. The fact that the necessary information will be available throughout the research and development process should help them avoid that risk.

19. 5.9 - Does the Protocol (and thereby the EU ABS Regulation) apply to genetic resources collected before it enters into force? No, the Protocol only applies to genetic resources accessed after it enters into force. 5.10 - What is the advantage of acquiring samples of genetic resources via a registered collection? Users who acquire a genetic resource from a collection included in the Union register will be considered to have exercised 'due diligence' as regards the seeking of all necessary information. This system of registered collections should substantially lower the risk of non-compliance. This should be particularly advantageous to academic researchers and SMEs.

20. 5.11 - Could a collection located outside the Union become a registered collection? For legal reasons, the register will only contain collections established within the Union. This is linked inter alia with the need for Member States' competent authorities to assess whether these collections fulfil the criteria for being put into the register. However, the EU remains open to look into enlarging this concept in the future, e.g. via bilateral agreements with other Parties to the Protocol. For the time being, however, the concept will be implemented firstly in the EU in order to gain the necessary experience.

21. 5.12 - What are the benefits in having a best practice recognized? Associations of users and other interested parties may ask the Commission to recognize a specific combination of procedures, tools or mechanisms overseen by an association as best practice. Competent authorities of the Member States should consider that the implementation of a recognized best practice by a user reduces that user's risk of noncompliance and justifies a reduction in compliance checks. The same should apply to best practices adopted by the collective of the Parties to the Nagoya Protocol (art. 20 of the Protocol).

22. 5.13 - Why has ABS been problematic in the past? Access and benefit sharing for the utilization of genetic resources was a controversial issue in the context of CBD discussions. The utilization of such resources is linked to the exercise of the sovereign right of states over their resources, the extent of rights of indigenous and local communities, and economic and technological development in provider countries. The convention includes a provision establishing a general principle calling for users to obtain the prior informed consent (PIC) of, and to share benefits with provider countries when their genetic resources are used for research and development. In the absence of the Nagoya Protocol, there was no sufficient legal framework to ensure that the genetic resources were obtained in compliance with domestic law of the provider country. Companies and scientists often developed commercial products based on genetic resources and, in many cases, filed patents using that material. In some situations this led to conflicts and accusations of "bio-piracy".

23. 5.14 - How will the Protocol help achieve broader conservation goals? The Protocol encourages Parties to direct benefits arising from the access to and utilization of genetic resources towards the conservation of biological diversity and the sustainable use of its components. It is also hoped that these benefits may help vulnerable populations that depend on genetic resources to use them sustainably. It could also help to enhance the management and establishment of protected areas that are important to conserve biodiversity.

24. 5.15 - Is there an obligation for provider countries to adopt access rules? No. Parties are free to decide whether they want to establish access legislation or not. If they don't, access to their genetic resources is considered to be free. The Nagoya Protocol also foresees a role of indigenous and local communities in the context of granting access. So, if the country decides to provide for rules on access, they may need to also include specific requirements concerning prior approval to be obtained from indigenous and local communities.

25. 5.16 - What happens in cases of non-compliance with the Protocol? The Protocol foresees the set-up of an ABS Clearing House, an international mechanism enabling the sharing of relevant information, such as national access measures applicable in provider countries, contact points as well as access permits issued by the authorities. This mechanism fosters compliance, but it also allows for identification of possible problems. In such a case, the country concerned will have the possibility to address a case to a court. As regards the obligation of states adhering to the Nagoya Protocol, the Protocol foresees the adoption of specific compliance procedures and mechanisms, including dispute settlement procedures, that will help Parties to comply and that will address cases of non-compliance. These will be agreed at a later date.

26. 5.17 - Are any genetic resources excluded from the scope of the Protocol? Human genetic resources are excluded from the scope of the Protocol. Further, genetic resources obtained from areas beyond national jurisdictions (e.g. the high seas) are also excluded from its scope. 5.18 - To what extent does the Nagoya Protocol address indigenous and local communities’ concerns? The Nagoya Protocol recognizes the capacity of indigenous and local communities to grant prior informed consent with respect to their genetic resources and traditional knowledge associated with genetic resources. Provider states need to ensure that indigenous and local communities can exercise their rights granted under the Nagoya Protocol and the respective national law. National rules on the rights of indigenous and local communities can sometimes entail challenging questions. This practical, political and image related factors should be considered in addition to the legal requirements.

27. 5.19 - Does the Nagoya Protocol create business opportunities? Yes, by creating a transparent and clear legal framework for access and by obliging user countries to provide for user measures that ensure the provider countries that their genetic resources will only be used in accordance with the applicable legislation and regulatory requirements, the Protocol will open the way for more access deals. Improved access to quality samples of genetic resources with high legal certainty and at the lowest possible transaction costs will maximize research and development opportunities on genetic resources. 5.20 - Why are there no dedicated provisions for non-commercial research? The Protocol does not distinguish between non-commercial and commercial utilization. In line with the Protocol, the EU ABS Regulation does not do so either. However, the Nagoya Protocol foresees that countries, when developing their ABS laws, shall create conditions to promote and encourage research which contributes to the conservation and sustainable use of biological diversity, particularly in developing countries, including through simplified measures on access for non-commercial research purposes, taking into account the need to address a change of intent for such research. Simplified measures on access for non-commercial research will be found in the respective access measures of provider countries, not in the EU ABS regulation which covers only the measures for user compliance.

28. 6. Global plan of action for Plant Genetic Resources The Second Global Plan of Action for Plant Genetic Resources for Food and Agriculture (Second GPA) is a strategic framework for the conservation and sustainable use of the plant genetic diversity on which food and agriculture depends. It was prepared under the aegis of the Commission on Genetic Resources for Food and Agriculture and adopted by FAO Council at its 143rd Session in November 2011. The Second GPA reaffirms the commitment of governments to the promotion of plant genetic resources as an essential component for food security through sustainable agriculture in the face of climate change.It is based on the findings of The Second Report on the State of the World’s Plant Genetic Resources for Food and Agriculture and inputs from a series of regional consultations and experts worldwide. It updates the Global Plan of Action on Conservation and Sustainable Use of Plant Genetic Resources for Food and Agriculture that was adopted by member countries in 1996. Updating the rolling Global Plan of Action also strengthens its role in the implementation of the International Treaty on Plant Genetic Resources for Food and Agriculture. The Second Global Plan of Action is thus current, forward looking and relevant to global, regional and national perspectives and priorities.

29. Second GPA is an agreed set of Priority Activities that directly address the new developments, opportunities and challenges facing plant conservation and use in the 21st century. These include new policies and international agreements that affect conservation, use and exchange of genetic resources, shift in food production trends, changing roles of public and private sector in crop improvement and delivery systems, advances in biotechnology, genomics and information technologies, new products derived from agriculture, impact of new pests, climate change and rapid urbanization on plant genetic erosion and vulnerability. The priority activities of the Second GPA addresses these developments to ensure that plant genetic resources for food and agriculture (PGRFA) continue to be available for current and future use for food security and sustainable agriculture. • The Second GPA aims to: • Promote cost efficient and effective global efforts to conserve and sustainably use PGRFA • Link conservation with use for a greater use of plant germplasm • Strengthen crop improvement and seed systems to foster economic development • Create capacities, strengthen national programmes and widen partnerships for PGRFA management • Strengthen implementation of the International Treaty on Plant Genetic Resources for Food and Agriculture.