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The Biodiversity, Genetic Resources and Benefit Sharing Status Quo in Brazil

From Inception to 2019 – First-Ever Regulatory Compliance Analytical Tool Straight from the Gut

Author

Diana Jungmann
MSc, PhD

Format

PDF

Published

Jan.2020

Versions

English
Portuguese

R$ 16.600 per License

approximately US$ 3,310

About the
Technical Report

This is a unique independent study developed over two years of research. It is an essential tool for compliance and advocacy purpose. Its main objective is to help professionals in the private and public sector understand the Brazilian Biodiversity Access and Benefit Sharing System (ABS) status quo, its changes since the law’s inception in 2000, and what steps should be taken to substantially mitigate risks of non-compliance.

Do you make use of Brazilian biodiversity in your commercial product or scientific research? As of November 2018 users accessing genetic resources and associated traditional knowledge are required to be registered on SisGen.
With official data we present key findings and interpretations of the law’s impact and challenges so professionals can benefit from a condensed source of information in this comprehensive Report.

The Brazilian ABS legislation is seen by members of the Convention on Biological Diversity (CBD) as an efficient benchmark in regulating access to biodiversity and a possible blueprint for the framework of other countries. However, its perceived efficiency is far from reality.

While the new Brazilian law implemented an online registration platform (SisGen) to manage access to genetic resources and associated traditional knowledge, no goals were established by the Federal Government to make use of metrics provided by the system. This issue extends beyond Brazil: over the last two decades, CBD member countries have been unable to properly evaluate national policies due to their own lack of data, metrics and goals.

As evidenced in the study, the Brazilian ABS System, presents unsatisfactory results since its creation. The undeniable conclusion impacts directly Brazil’s decision to ratify the Nagoya Protocol.

The resources provided in this Technical Report bring a much clearer degree of transparency on the current ABS System implementation and provide the necessary tools for stakeholders to pursue a path where effective solutions can be achieved.

DETAILS

List of Figures
Abbreviation
Foreword
Executive Summary
1. Introduction
2. Bioeconomy, Genetic Resources, Technology and Development
3. Genetic Resource and Multilateral Frameworks

3.1. Convention on Biological Diversity (CBD)
3.2. Nagoya Protocol
3.3. International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA)
3.4. Paris Convention
3.5. Agreement on Trade Related Intellectual Property Rights (TRIPS)
3.6. International Union for the Protection of New Plant Varieties (UPOV)
3.7. Benefit Sharing in the CBD and ITPGRFA
3.7.1. Benefits Sharing in the ITPGRFA
3.7.2. Benefits Sharing in the CBD
4. Overview of the Two Brazilian ABS Systems
4.1. The Provisional Measure 2,186/2001
4.2. The construction of the New ABS Regulatory Framework and the Brazilian Political Scenario
4.3. The Law 13,123/2015
4.4. The comparison of the Key Concepts of PM 2,186/2001 and Law 13,123/20105
4.4.1. Concept of the Brazilian Genetic Heritage
4.4.2. Concept of Access to the Genetic Heritage
4.4.3. Concept of the Traditional Knowledge Associated with Genetic Heritage
4.4.4. Concept of the Access to Traditional Knowledge Associated with Genetic Heritage
5. The New ABS System in Brazil

5.1. Compliance Parameters
5.1.1. Origin of the Genetic Heritage
5.1.2. The Concession of Intellectual Property Rights
5.1.3. Types of GH and TK Access Activity in Brazil
5.1.4. The Adjustment Process to Law 13,123/2015
5.1.5. The Regularization Process to Law 13,123/2015
5.1.6. Commitment Term for Regularization
5.2. Compliance for Benefits Sharing
5.2.1. Modalities of Benefits Sharing
5.2.2. Monetary Benefit Sharing
5.2.3. Non-monetary Benefit Sharing
5.2.4. Sector Benefit-Sharing Agreement
5.2.5. National Benefit Sharing Fund
5.2.6. The complexity of the Benefit-Sharing Chain
6. Results of the Access to Biodiversity and Benefits Sharing in Brazil between 2000–2019
6.1. Access and Benefits Sharing during the PM 2,186/2001
6.1.1. Authorization of Access to the GH and TK
6.1.2. Contracts Signed for the Commercialization of Products with the GH and TK
6.1.3. Sharing of the Paid Monetary Benefit
6.1.4. IBAMA Inspection and Fines for Non-Compliance with the PM 2,186/2001
6.2. Access and Benefits Sharing in the Law 13.123/2015
6.2.1. Compliance on the Registration of Access to the GH and TK
6.2.2. Compliance on the Origin of the TK
6.2.3. Compliance on the Origin of the GH
6.2.4. Compliance on the Remittance of GH Abroad
6.2.5. Compliance on the Notification and Payment of Benefit Sharing
6.2.6. Compliance on the Commitment Terms
7. Discussion
7.1. Compliance Data on the Regulatory Frameworks of the ABS in Brazil
7.2. The Compliance of the Law 13,123/2015 until Date: Overall View
7.3. The Compliance of the Law 13,123/2015 and the Universe of Potential Users
7.4. The Payment of Benefit Sharing in the Law 13,123/2015
7.5. Genetic Heritage and Traditional Knowledge Users Category
7.6. Potential Genetic Heritage and Traditional Knowledge Users from the Business Sector in Brazil
7.7. Potential Genetic Heritage and Traditional Knowledge Users from the Academic Research Sector in Brazil
7.8. The Consequence of Non-Compliance by the Genetic Heritage and Traditional Knowledge Users
7.9. The Compliance Inspection of the regulatory framework by IBAMA
7.10. Brazil and the Nagoya Protocol
7.10.1. Brazil as a Genetic Resource User
7.10.2. Possible Impacts of the Nagoya Protocol on Brazil
7.11. Prosperity and Opportunities in the Sustainable Use of Biodiversity
8. Conclusion
Figure 1. Chronology of the multilateral regulatory framework derived from the Convention on Biological Diversity and its adoption by Brazil, which does not include the Nagoya Protocol.

Figure 2. Chronology of the implementation of the Brazilian Regulatory Framework related to the Convention on Biological Diversity (CBD).

Figure 3. Selection of the six Multilateral Treaties related to the use of genetic resources, highlighting the number of member countries and the status of Brazil. Data obtained from the websites of the organizations treated in 2019.

Figure 4. Selection of the Brazilian Legislation Linked to the Regulation of Access to Genetic Resources and Intellectual Property Rights from 1995 to 2019.

Figure 5. ITGHRFA Benefit Sharing Fund based on voluntary donor contributions. Contribution period November/2008 to March/2018.

Figure 6. Amount of the ITGHRFA disbursed by the Benefit Sharing Fund for project cycles. FAO Note: the data present (in Figure 5) includes contributions for the fourth project cycle of the BSF, which had not yet been disbursed in March 2018.

Figure 7. Schematic representation of the complexity of the Brazilian ABS System under the repealed PM 2186/2001 and in force Law 13,123/2015.

Figure 8. Schematic representation of the key concepts of CBD and Nagoya Protocol.

Figure 9. Comparison of the concepts of Genetic Heritage of the repealed PM 2.186/2001 and of the in-force Law 13.123/2015.

Figure 10. Comparison of the Concepts of Access to the Genetic Heritage of the repealed PM 2,186/2001 and the in-force Law 13.123/2015.

Figure 11. Comparison of the Concepts of Traditional Knowledge associated with the Genetic Heritage of the Repealed PM 2.186/2001 and the in-force Law 13.123/2015.

Figure 12. Comparison of the Concepts of the Access to Traditional Knowledge associated with the Genetic Heritage of the Repealed PM 2.186/2001 and the in-force Law 13.123/2015.

Figure 13. Schematic view of the compliance requirements of Law 13.123/2015 according to the types of activities planned and by the size of the users.

Figure 14. Schematic representation of the new concepts established by Law 13.123/2015 regarding the reproductive material, intermediate product and finished product .

Figure 15. Schematic representation of different actors in the production chains, from the reproductive material link (a native of Brazil) to the industrialization of intermediate and finished products, demonstrating the intricate real-world of the compliance required by the GH and TK users and the payment – or not, of the RB in accordance with the Law 13.123/2016.

Figure 16. Overview of the benefits sharing payment compliance for “agricultural” and “non-agricultural” activities derived from finished GH or TK products and by enterprise sizes.

Figure 17. The number of access to the GH and TK authorized in Brazil from 2000 to 2015 when the PM 2,186/2001 was in force.

Figure 18. The number of benefits sharing agreements signed between user – provider and user – Union Companies between 2000 – 2015, during the period the PM 2,186/2001 was in force.

Figure 19. The total amount of monetary benefits sharing received by the Brazilian government between the year 2000 and 2015, under the period in which the PM2.186/2001 was in force.

Figure 20. Geolocation of the Middle Juruá Extractive Reserve, in the state of Amazonas, which received R$ 4 million reais as monetary benefits sharing from the PM 2.186/2001.

Figure 21. Comparison between the total amount received as monetary RB and the value of the fines imposed by IBAMA under the PM 2.186/2001.

Figure 22. The number of registrations in the SisGen between 09/06/2017 and 09/13/2019 by institutions type approved by the CGen.

Figure 23. The number of SisGen registrations from 09/06/2017 to 09/13/2019 by the type of access to GH, GH + TK and only TK according to the Law 13123/2015.

Figure 24. The number of SisGen registrations between 09/06/2017 to 09/13/2019 by purposes.

Figure 25. The number of SisGen registrations between 09/06/2017 to 09/13/2019 by origin of TK.

Figure 26. The number of SisGen registrations between 09/06/2017 to 09/13/2019 by origin of GH.

Figure 27. The number of registrations in the SisGen from 09/06/2017 to 09/13/2019 by Biological Group.

Figure 28. The number of GH samples remittance abroad in the SisGen from 09/06/2017 to 09/13/2019. Highlight for the 10 largest destinations.

Figure 29. The notification number in the SisGen between 09/06/2017 to 13/09/2019 by product type – finished and reproductive material. Source CGen-MMA. 54 Figure 30. The number of notifications in the SisGen from 09/06/2017 to 09/13/2019 by benefits sharing type.

Figure 31. The number of ABS Term of Commitment received and signed by the Ministry of Environment during 11/06/2017 and 11/05/2018, related to the regularization process window for the access to the GH and TK according to the Law 13.123/2015 and Decree 8772/2016.

Figure 32. Comparison of the size of companies in the industrial sector with their participation in the Brazilian industrial GDP.

Figure 33. The 1%, 5% and 10% scenarios designed by the author to calculate the number of potential business users who from June 2000 to September 2019 had at least one access to the GH/TK under the Law 13.123/2015 that requireded compliance.

Figure 34. The compliance rate for the Law 13.123/2015 for the hypothetical scenarios of potential business users in the 1%, 5% and 10% proportions that made at least one access to the GH or TK in Brazil from June/2000 to September/2019 that required registration in the SisGen. Figure 35. The number of research lines and researchers in Brazil classified by the major areas of knowledge according to the 2016 census.

Figure 36. Calculation of the number of projects from the lines of research in five areas of knowledge, according to percentages Arbitrated in the simulation carried out by the author from June/2000 to September/2019, which required registration in the SisGen.

Figure 37. Simulation of three GH/TK access registration compliance scenarios in the academic environment, employing the total number of projects from research lines in five areas of knowledge selected by the author from June/2000 to September/2019 that requITRed registration in the SisGen.

Figure 38. Typification of infringements against the GH/TK and the equivalent fines according to Decree 8.722/2016.

Figure 39. Illustration of the regulatory complexity required of the GH/TK users in the Brazilian law (Law 13.123/2015) compared to the size of the Nagoya Protocol, to which Brazil is not yet a party.

Figure 40. Illustration of the regulatory complexity in the industrialization of bioproducts composed of different GH/TK from different jurisdictions, with different legislations under the Nagoya Protocol, highlighting the possible cumulative RB payments.

Figure 41. Compliance design suggestion for a new ABS policy focused on innovation and development in Brazil. Natural person, traditional farmers, micro and small users exempt from compliance. Academic researchers with GH and TK, compliance via CNPq System. Medium and large companies using the GH/TK, compliance via the SisGen.

This study makes an unprecedented and robust analysis of compliance with the Brazilian regulatory framework for access to biodiversity and benefits sharing (ABS). It brings a rich survey of data and sources to evaluate this public policy, implemented since June 2000 by a Provisional Measure that after 16 editions was consolidated as MP 2.186/2001, repealed in November 2015 by the entry into force of Law 13.123/2015.

The focus of the work is on the access to genetic resources (RG) and benefits sharing (RB), not delving deeper into issues related to the traditional knowledge associated (CTA) with the genetic resources.The Convention on Biological Diversity (CBD) aims to promote the conservation of biodiversity, its sustainable use and the fair and equitable distribution of the benefits arising from the economic use of genetic resources while respecting the sovereignty of each nation over its existing territory.

Since its inception about 26 years ago and after many millions of dollars of investment in multilateral discussions, definitions and implementations of policies and specific legislation, as well as capacity building, the results of the CBD and its member countries, such as Brazil, appear to be limited and/or not measurable. Data on monetary value from the sharing of benefits are difficult to find from the expected information sources. The author reiterates the statement made by other colleagues in the field since when she consulted directly with the CBD secretariat on such data under the Nagoya Protocol, the answer was that “this data does not exist”. The same should be true for biodiversity conservation data.

Sustainable development represents one of the greatest challenges facing humanity in the 21st century, hence the great importance of the operational success of the CBD. The new frontier of world economic growth is based on the life sciences. “Bioeconomics” is the name given to this groundbreaking revolution directly linked to environmental sustainability, inventions and utilization of biological processes in the areas of human health, agribusiness, industrial processes and biotechnology.

To enable the flourishing of bioeconomics, it is essential to recognize that it depends on an advanced understanding of genes, cellular processes, and the multi-sectoral integration of applied biotechnology. Another relevant concept in this context of transformation is the “circular economy”. It presents itself as the science that rethinks economic practices, going beyond the processes of – reducing, reusing and recycling – seeking to unite the sustainable model with the technological and commercial rhythm of the modern world, which cannot be ignored. Therefore, when discussing and evaluating national and multilateral policies on access to genetic resources, such advances in science and technology need to be considered, otherwise such policies become obstacles to the advancement of science, technology, innovation and of development. Policies based on penalty rules and limitations to access to RG which are increasingly decrypted, edited, and digitally shared, seem to have little future in a world connected to high-speed networks. The reality is that the information is transmitted and archived simultaneously in redundant databases in various countries (cloud computing), as is communication and collaboration between researchers, which happens continuously and without borders.

Having a regulatory framework that fosters innovation and, therefore, that generates benefits from a new business based on national biodiversity, involves the capacity of Brazil to understand and adapt to the unquestionable reality of the technological paradigm. It is vital to transition from an existing protectionist policy to an incentive policy that can transform the condition of the country from RG and CTA provider to provider and user of these resources. Therefore, it is essential that the regulatory framework generates a pro-science and pro-business and pro-innovation environment, fostering new markets, wealth and prosperity for the country.

An overview of the context on which the study is based is given in the Introduction Chapter, providing a broad and chronological spectrum of the CBD and its treaties, as well as matching the internalization in Brazil to this multilateral regulatory framework.

Chapter 2 provides an overview of the challenges facing humanity and the possibilities posed by the bioeconomy and circular economy, highlighting the importance of biological resources, technology, sustainable development and the solutions that need to be created and deployed to provide, for example: drinking water, food, energy, health, education, housing, mobility, among other needs, considering the scenario of population increase and ageing, as well as climate change.

Chapter 3 provides a connection of the multilateral regulatory frameworks related to the theme of genetic resources and intellectual property, including the CBD, the Nagoya Protocol, the International Treaty on Plant Genetic Resources for Food and Agriculture (TIRFAA/FAO), the Paris Convention, the Agreement on Aspects of Trade-Related Intellectual Property Rights (TRIPS), and the Union for the Protection of Plant Varieties (UPOV), highlighting the corresponding Brazilian laws, as well as issues relating to mechanisms and the results of benefits sharing models created by the CBD and TIRFAA.

Chapter 4 gives an overview of the two already established ABS Systems in Brazil under MP 2,186/2016 and the Law 13,123/2015 and highlights the comparison of the concepts between these legislations.

Chapter 5 focuses on the description of the current ABS System in force in Brazil, instituted by the Law 13,123/2015, highlighting the Electronic System of Genetic Heritage Management (SisGen), as well as the main compliance parameters required by the GR and TK users in the country.

Chapter 6 is entirely devoted to the data and information that shape the various outcomes on compliance with the repealed MP 2.186/2001 and the in-force Law 13.123/2015. It shows the number of RG and CTA authorizations and registrations, the number of academic and business users with approved registrants, RB contracts, amounts paid and the use of monetary resources, fines applied to the Brazilian RG violations in quantities and amounts, registrations of regularization and terms of commitments delivered and signed, registration by species of RG, by origin of PG and CTA, identification of the ten largest countries of consignment destinations of the Brazilian RG and various other critical data for the assessment of the regulatory framework. It provides an unprecedented overview of the national ARB policy from June 2000 to date, making exceptional correlations between the results achieved.

Chapter 7 discusses the critical points of the findings of the study. It sheds light on key issues, certainly expected and welcomed by those professionals who follow the CBD themes, with particular attention to the Brazilian ARB System. Based on the official data presented and the exercise-building scenario carried out by the author, it demonstrates the previously unknown results of many, regarding the negligible compliance rate achieved by the users, also evidencing the inability of the Brazilian state to operate, for the second time, the regulatory framework for access to biodiversity. It looks at several relevant factors about the impact of the Nagoya Protocol on its ratification by Brazil. It presents the picture of inefficiency, high complexity and a large number of users submitted to the legislation. It highlights the possible impacts and consequences that need to be mitigated for the business environment and academia, and finally suggests a new design for the access to biodiversity in the country.

Chapter 8 concludes the study by summarizing the findings and putting into perspective the situation found, as well as bringing to scene the direct relationship of the subject with the ratification or not of Brazil to the Nagoya Protocol, meaning if affirmative, an increase in the already existing complexity under this policy and the current inability of the State to manage it. Adjustments are undoubtedly necessary.

Given the content of the study, you are invited to reflect and draw your own conclusions, as well as create possible scenarios not included or thought of here, and, if possible for foreign practitioners, evaluate realistic scenarios that occur in their jurisdictions and share them with the author to enrich the discussion.

Finally, after almost two decades, it is essential to ensure that users subject to the regulation of access to the Brazilian biodiversity have a legally secure non-bureaucratic system that promotes innovation and is capable of fostering and attracting investment for research and development activities in the biological area. Within an enabling environment, Brazil can certainly generate wealth through new business with biodiversity assets, which in turn can promote new markets and new job opportunities, generating income, building and contributing to the economic and social development of this nation. By aligning the direction, meaning and purpose, it is possible to transform the energy of all the resources used, into a driving force capable of turning the virtuous cycle of abundance and prosperity for the actors involved in the process, whether PG and CTA providers, researchers, entrepreneurs, the government and ultimately the society. Thus, the Brazilian state will be able to deliver the long-awaited benefits by establishing a facilitating public policy, designed to promote the sustainability of our biomes and ecosystems, contributing directly to the conservation of the biodiversity of planet Earth.

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Author Bio

Diana Jungmann is founder of the 14Bisness. Holds a PhD degree in Molecular Biology, MSc in Biophysics and Executive Education in Intellectual Property (IP) and Business Strategy from Harvard, Wharton and IMD.

Industry-Government liaison for the access and benefit sharing new regulatory framework in Brazil.

Former head and spoke person of IP and Bioeconomy at the highest-level organization representing industry in Brazil (CNI). Diana co-authored the pioneer Bioeconomy Agenda for Brazil and was the Bioeconomy Forum coordinator. She created and co-authored the “IP Program for Industry Innovation” impacting more than half a million professionals and students in the country.

Former Ambassador to Brazil of the Intellectual Property Commission of the ICC in Paris and Member of the Task Force on ABS.

Entrepreneur, inventor, consultant and speaker. Her cross-cultural and cross-sector skills grants Diana a unique perspective towards bioeconomy, IP and innovation. She is involved in high-level public policy discussions with industry, academia and government leaders. She believes in innovation as a means of creating opportunity, abundance and prosperity for people and society.

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