The Nagoya Protocol

 

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IMPLEMENTATION OF THE NAGOYA PROTOCOL ON ACCESS AND BENEFIT SHARING Dialogue between Brazil and the European Union

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FEDERATIVE REPUBLIC OF BRAZIL President Michel Temer MINISTRY OF SCIENCE, TECHNOLOGY, INNOVATION AND COMMUNICATION Minister Gilberto Kassab Executive Secretary Elton Santa Fé Zacarias Operacional Responsibility Andrea Ferreira Portela AUTHORS Kate Davis Paulo Holanda Chris Lyal Manuela da Silva Eliana M. G. Fontes TECHNICAL REVIEW Eliana Fontes MINISTRY OF PLANNING, DEVELOPMENT AND MANAGEMENT Minister Dyogo Oliveira  Secretary of Management Gleisson Cardoso Rubin Project’s National Director Marcelo Mendes Barbosa 2

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Implementation of the Nagoya Protocol on Access and Benefit Sharing DELEGATION OF THE EUROPEAN COMMISSION TO BRAZIL Chief Ambassador of the Delegation of the European Commission to Brazil João Gomes Cravinho Minister Counselor - Head of Cooperation  Thierry Dudermel  Attaché of Cooperation Coordinator of the Project “Support to EU-Brazil Sectorial Dialogues” Asier Santillan Luzuriaga  Executing Consortium CESO Development Consultants/FIIAPP/INA/CEPS CONTACTS Direção Nacional do Projeto  + 55 61 2020.4945 / 4168 / 4785 dialogos.setoriais@planejamento.gov.br www.sectordialogues.org © European Union, 2016 The content of this study does not reflect the official opinion of the European Union or of Brazil. Responsibility for the information and views expressed in the text therein lies entirely with the author(s). Reproduction is authorised provided the source is acknowledged. 3

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© União Europeia, 2016 O conteúdo deste estudo não reflete a opinião oficial da União Europeia ou do Brasil. A responsabilidade pelas informações e opiniões expressas no texto reside inteiramente com o autor(s). Reprodução autorizada desde que a fonte seja citada. 4

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Implementation of the Nagoya Protocol on Access and Benefit Sharing IMPLEMENTATION OF THE NAGOYA PROTOCOL ON ACCESS AND BENEFIT SHARING Dialogue between Brazil and the European Union 5

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SUMMARY Context................................................................................................................... 13 The Project............................................................................................................. 14 Brasília workshop........................................................................................... 16 London workshop ......................................................................................... 16 Brussels Meeting .......................................................................................... 17 Outcomes...................................................................................................... 20 Legal framework .................................................................................................... 20 The Nagoya Protocol .................................................................................... 20 The EU Regulation......................................................................................... 21 Brazilian Legislation ...................................................................................... 26 Definitions and Scope........................................................................... 27 Competent Authority.............................................................................. 29 Access................................................................................................... 30 Sending and Shipment.......................................................................... 31 Economic Exploitation........................................................................... 34 Verification process............................................................................... 34 Associated Traditional Knowledge........................................................ 36 Benefit Sharing ..................................................................................... 36 Gaps and bridges between Brazilian and EU measures.......................................... 38 Terminology.................................................................................................... 38 Table 1. Terms employed in ABS transactions in Brazil and the EU..... 39 10

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Implementation of the Nagoya Protocol on Access and Benefit Sharing Coordination of monitoring stages................................................................. 42 Table 2. Comparison of the monitoring points at which registration/ notification of use is required by Brazil and Declarations of Due Diligence are required under the EU Regulation................................................... 43 Benefit-sharing responsibilities...................................................................... 44 Monitoring, tracking and tracing.............................................................................. 45 Purpose of monitoring genetic heritage........................................................ 46 Sectoral tracking/tracing systems ................................................................ 47 Use of unique identifiers to enable traceability............................................. 49 By users to multiple resources.............................................................. 50 By users to individual strains or specimens.......................................... 50 By users to manage developments in the value chain and manage ABS and contract compliance...................................................................... 50 To facilitate wider communication between users and providers......... 51 To identify permits and other documents providing legal certainty or contractual requirements...................................................................... 51 Characteristics of a workable traceability system......................................... 52 Model contractual clauses: The Brazilian MTA....................................................... 53 Best practices to manage responsibilities and support traceability........................ 54 Raising awareness, sharing information and building skills.................................... 55 11

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Context Implementation of the Nagoya Protocol on Access and Benefit Sharing How can countries ensure that they benefit from the use of their genetic resources by others? No benefits from use can arise if no use is made, but history tends to show that benefits do not necessarily flow from users to providers without prompts, incentives, checks and penalties. Brazil and European countries have exchanged genetic resources for centuries. There is strong mutual recognition of the potential benefits that can be created and shared through greater academic and commercial exchange. The Nagoya Protocol provides a new framework for these relationships, adding clarity and force to the original access and benefit-sharing (ABS) provisions of the Convention on Biological Diversity. Countries that have exercised their sovereign right to decide how others may access their genetic resources must set out clear measures; countries where genetic resources are utilised must ensure that users are complying with those providers’ measures. To support compliance, the Nagoya Protocol establishes the structures for an international system to monitor the utilisation of genetic resources. 13

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The EU and many European countries have ratified the Protocol and Brazil is expected to ratify in due course. Brazil and the European Union have developed new legal measures in response to the Protocol. Exactly how these measures will function together between countries and across sectors is not yet known. A first step is for all actors to understand what these regulations require, and how the requirements can be handled in practice. Sectors differ in their use and management of genetic resources, and sectoral measures such as contractual agreements and best practices can supplement and support these legal measures, so understanding how the measures will work can only be achieved through input from a wide range of users. Tracking and tracing methods are essential for monitoring utilisation under the new legal frameworks, so that Brazilian resources remain linked to their source information as they travel, users in the EU can determine the history and legal background of the resources they wish to use, and benefits that arise can be shared with Brazil. Sectoral tracking practices and capacities need to be considered so that global and national monitoring systems are efficient and cost-effective for providers and users. Although explicitly framed as a BrazilEU dialogue, the issues addressed here are generic and could be considered as applicable to all Parties to the Protocol. The Project The Brazil-EU project ‘Implementation of the Nagoya Protocol on Access to Genetic Resources and Benefit Sharing – Fourth Phase,’ conducted April-July 2016, continued the dialogue between Brazilian and European governments and sectoral experts. This fourth phase specifically aimed to strengthen the regulatory capacities of Brazil and the EU by promoting the traceability of genetic resource samples through the research and product development chain. To achieve this overarching objective, the project focussed on how information about the origin and conditions of access to genetic resources is made available along the supply and value chain, and how information on utilisation and benefit generation are made available to Brazil (tracking, tracing and monitoring). While the Nagoya Protocol provides generic solutions, the detail is found in national or regional regulations and laws, and in stakeholder activities. It is in comparison of these that mismatches of expectation and requirements can be found and addressed, to the benefit of all. The project therefore sought to (i) characterise the main features and properties of tracking and monitoring systems for the providers and users of genetic resources (ii) identify the necessary workflows to manage 14

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Implementation of the Nagoya Protocol on Access and Benefit Sharing such a system, and (iii) discuss and characterise their main features to ensure practical implementation, including through interoperability with other systems, such as the ABS Clearing House of the Convention on Biological Diversity. It also considered robust and simplified mechanisms and tools to comply with the Nagoya Protocol, with the expectation that such tools would (i) provide legal certainty and consequently (ii) increase the interest and investment in knowledge and bioprospecting of Brazilian biological diversity, stimulating scientific and technological exchanges between Brazil and the EU, while (iii) protecting the interests of all stakeholders. This in turn would contribute to conservation and sustainable use of Brazil’s outstanding biodiversity. The project examined the new monitoring systems established by: the Nagoya Protocol; Brazilian Law 13.123/2015, which sets out a new access regime based on a registration process; and European Union Regulation (EU) 511/2014, which sets out a compliance system for users in EU Member States based on due diligence measures. The Law and the Regulation are both now in force, although comprehensive systems for implementation between different Brazilian agencies and in some EU Member States are not yet finalised. Brazilian Decree 8.772/2016, setting out implementation measures for Brazilian Law 13.123, was promulgated during the early stages of the project. The dialogues focused on how these legislative measures for monitoring genetic resource utilisation will function together, rather than in isolation, and what level and kind of tracking and/or tracing are necessary to comply with them and achieve the Protocol’s benefitsharing objective. The project activities comprised: SS A background paper on the legal frameworks for monitoring and sectoral tracking/tracing practices, to support workshop discussions1; SS A Brasília workshop, with wide cross-departmental and crosssectoral participation, including EU and SCBD representatives2; SS A London workshop, with crosssectoral EU participation and Brazilian representatives, in which three carefully-designed hypothetical case studies were used to explore how legislation and sectoral systems would apply3; SS A meeting in the EU Commission in Brussels to present and 1.  https://www.embrapa.br/recursos-geneticosebiotecnologia/dialogo-protocolo-de-nagoya 2.  https://www.embrapa.br/recursos-geneticosebiotecnologia/dialogo-protocolo-de-nagoya 3. http://nagoyaprotocol.myspecies.info/node/23 15

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discuss with EU Member State representatives the Brazilian law and EU Member States’ ABS measures. Brasília workshop The Brasília workshop, conducted at Embrapa Genetic Resources and Biotechnology, began with formal presentations from Brazilian government and invited EU government, CBD Secretariat and sectoral representatives. Two days of working group discussions followed, in plenary with PortugueseEnglish translation. The workshop concluded with a final day featuring the transmission of the results of the working group in a public communication seminar. Due to the very recent release of the Decree, the working group was provided with the opportunity to query representatives of the Ministry of the Environment as to how the new Brazilian access system is envisioned to function, to provide firmer ground for subsequent discussion of other questions. The principal questions addressed by the working group were: (1) What is the purpose of monitoring and tracking genetic resources, from the Brazilian perspective? (2) What are the characteristics of a workable tracking/ traceability system – and what level and kind of tracking/tracing is needed for compliance with Brazilian and EU monitoring requirements? (3) What could the simplest system that would meet Nagoya Protocol/EU/Brazil requirements look like? (4) What identifiers are needed for the ABS system to work – to what should they be applied and do they need to be globally unique? (5) What is the role of best practices in the tracking/ monitoring context? The working group’s results included clarifications regarding the Brazilian law and a set of recommendations for further action, including the establishment of an inter-agency, cross-sectoral Task Force to find ways to share, simplify and coordinate access-related processes in Brazil, such as collection, transfer and export. London workshop The London workshop, conducted at the Natural History Museum, involved Brazilian Government representatives and EU sectoral representatives, several of whom had also participated in the Brasília workshop. The London workshop aimed to: (1) inform EU representatives of new legislation in Brazil; (2) inform Brazilian representatives of EU legislation and its implications for ABS compliance in R&D in the EU; (3) identify issues of tracking and tracing GR and ATK originating in Brazil and being used in the EU; (4) explore expectations and understanding associated with legal and contractual obligations, noting any differences in expectations 16

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Implementation of the Nagoya Protocol on Access and Benefit Sharing between different stakeholder groups; and (5) identify areas of concern for further action, proposing solutions where possible. After formal presentations from Brazilian and EU representatives on the Brazilian and EU legislation and short presentations on sectoral tracking and tracing systems, participants discussed the requirements and systems from provider country and user perspectives. On the second day, three working groups discussed hypothetical case studies involving the acquisition and use of genetic resources (Box 1). Brussels Meeting The Brussels meeting enabled Brazilian and EU representatives from the European Commission and Member State checkpoints to exchange information about their respective measures, including how the EU compliance measures are being implemented in each country. Box 1: Case studies explored in the project The London workshop presented three case studies, all hypothetical but containing likely real-world scenarios. For each, participants were asked to consider the supply and value chain activities from access to the end of utilisation and commercialisation, if it occurs, and questions were posed regarding the responsibilities and expectations of each of the stakeholders - Providers, Regulators, and Users. Participants were encouraged to consider the perspectives of the stakeholders (how significant the situation is for each actor, how they will know what to do in their workflow); whether there are soft solutions that need to be embedded in organisational policies or sectoral best practice; how tracking/tracing/monitoring systems, if they are in place, should operate between different actors, or if there are reasons (e.g. confidentiality) that might militate against their use. 17

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Case study 1: Academic study and potential commercialisation A researcher is studying venom in the UK, particularly its biochemical properties, to inform his grant-funded taxonomic research. He accesses Brazilian snakes in situ and from a British pet shop for non-commercial research; the snakes from the pet shop include both wild-caught specimens and their progeny. He partners with other research organisations (one in Germany, one in Australia) to obtain access to their analytical facilities, since he is unable to analyse the chemical constitution of the venom. All his results are published, including the chemical composition of the venoms (on the publicly-available European Molecular Biology Laboratory site, EMBL). Both German and Australian organisations may have non-commercial and commercial interests, and pursue commercial lines of research with the analytical outputs. A third commercial company in the UK downloads the chemical composition data from the EMBL site, and develops a product for market. 18

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Case study 2: Supply chain and value chain Plant samples are collected in several countries including Brazil by a number of collectors working for an SME. These plants are sold on through an intermediary to a product development company for scientific research of potential aromatics. After analysis and screening, a set of chemicals is taken forward from these plants for modelling and synthesis. Following final selection the chemical formulae and a synthesis system are sold to a cosmetics firm for further work and eventual marketing as part of a range of beauty products. In a separate transaction, a Brazilian company extracts the sap of the plants and exports it to the EU as a health drink. An EU company purchases the drink and extracts chemicals as described above, selling the formulae on to a cosmetics company. Case study 3: Cross-over from non-commercial to commercial An EU researcher collects fungi in Brazil as a part of his research into factors affecting plant growth. He selected the fungi with advice from an indigenous culture (who live in Brazil and also Peru and Colombia). In the EU he extracts the active chemicals in grant-funded work. He publishes the results of his research, including the chemical composition, on a public database. Fungal cultures are transferred to a culture collection, the researcher having no further interest in them. A pharmaceutical company recognises the potential value of one of the chemicals, and is aware from published studies elsewhere that the fungus concerned is known to have traditional medical properties developed by the indigenous culture, at least in Peru. The pharmaceutical company acquires some of the strain from the culture collection, synthesises the chemical, and eventually it appears as a part of a product. 19

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