Niveau juridique : International
Lors de cette réunion, les experts se sont penchés plus précisément sur deux sujets :
L’accès et partage des bénéfices et ressources génétiques pour l’alimentation et l’agriculture (RGAA)
Avec l’étude de la typologie des mesures mises en place par les pays sur l’accès et le partage des bénéfices en lien avec les RGAA et du projet de questionnaire en ligne sur les implications des mesures d’accès et de partage des avantages pour l’utilisation et l’échange des ressources génétiques pour l’alimentation et l’agriculture et pour le partage des avantages
Les Séquences digitalisées d’information (DSI) et ressources génétiques pour l’alimentation et l’agriculture.
Ici, les experts ont plus précisément étudié le document « Digital sequence information and genetic resources for food and agriculture » (DSI et RGAA) et pris note du projet d’étude intitulé « The role of digital sequence information in the conservation and sustainable use of genetic resources for food and agriculture : opportunities and challenges » (Le rôle de l’information numérique sur les séquences dans la conservation et l’utilisation durable des ressources génétiques pour l’alimentation et l’agriculture : Opportunités et défis).
Les experts recommandent de continuer le travail sur ces questions, et notamment encourager les membres à coordonner leurs travaux
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Extraits du document « Séquence digitale d’information et RGAA » :
« 3. The present document provides information on the generation, storage, access to and use of DSI for research and development related to GRFA. Further information is provided in the study on The role of digital sequence information for the conservation and sustainable use of genetic resources for food and agriculture: Opportunites and challenges. The document also summarizes relevant developments in other fora and briefly discusses, in the light of these developments, options to address ABS for DSI. (…)
II. THE ROLE OF DIGITAL SEQUENCE INFORMATION FOR FOOD AND AGRICULTURE
4. There is no universally agreed definition for DSI. The scope of DSI can include anything from DNA and RNA sequences, protein sequences to metabolites and other macromolecules, and may include associated information and traditional knowledge. (…)
Generation and storage of DSI
13.DSI is primarily the product of sequencing technologies that have become faster, cheaper and more accurate in recent years. Data are held in many places, in public and private databases. A significant amount of DSI is stored in an estimated 1 700 publicly accessible databases and repositories of biological and associated information worldwide. The International Nucleotide Sequence Data Collaboration (INSDC) between GenBank (United States of America), the European Nucleotide Archive (United Kingdom of Great Britain and Northern Ireland) and the DNA Data Bank (Japan) provides the key infrastructure for publicly available DSI. The three databases exchange data regularly and maintain an up-to-date copy of all published information. Little is known about private databases.
Access to public databases
14.The INSDC has a uniform data-sharing policy of free and unrestricted access to all the data records without use restrictions, licensing requirements, or fees on the distribution or use. Patented sequences may be deposited in the INSDC. However, the INSDC will not attach statements to records that restrict access to the data, limit the use of the information in these records, or prohibit certain types of publications based on these records.
Making use of DSI
15.However, unrestricted access to public databases does not mean that DSI may be used by everyone in the same way. Substantial technical, institutional and human capacity is required to access and make full use of the innovation potential of DSI. Though at varying degrees and depending on the status of technological development, many developing countries lack access to the necessary technical infrastructure, financial and human resources to fully exploit the potential DSI offers. (…)
16. Closely linked to the challenge of technical, institutional and human capacity required to access and make use of DSI are the challenges of storage, distribution and analysis tools. Given the exponential growth of genomic data, the infrastructure for the storage and distribution of DSI may well change in the future. While the cost of this infrastructure is currently predominantly met by public funds, such funding may not always be available and sufficient and alternative funding models may need to be considered. Such models could restrict access to DSI. However, they could also provide sustainable funding for the life science infrastructure without restricting access to DSI, take into account equity considerations and even provide the framework for benefit-sharing arrangements, for example through subscription fees, data deposit and access or membership fees. (…)
IV.REGULATING ACCESS AND BENEFIT-SHARING FOR DIGITAL SEQUENCE INFORMATION ON GENETIC RESOURCES
49.Currently, very few countries seem to require prior informed consent (PIC) and mutually agreed terms (MAT) where access is sought to DSI only (rather than to the physical genetic resource).53 Some countries, while not restricting access to DSI, require that benefits derived from DSI obtained from their genetic resources are shared. There is a concern that in the absence of a global agreement on ABS for DSI, an increasing number of countries could adopt domestic ABS measures for DSI.
50.At the global level, consultations held over the past years, in particular under the CBD, have generated various options to regulate ABS for DSI. At least 11 options, including suboptions have been distinguished:
54(1)Option 0 Status quo
(2)Option 1 DSI is treated like genetic resources, where country PIC and MAT apply
(3)Option 2.1 DSI requires a country MAT but no PIC
(4)Option 2.2 DSI requires a global standardized MAT and no PIC
(5)Option 3.1 DSI access requires payment
(6)Option 3.2.a Payment/levy on services and products as inputs to research
(7)Option 3.2.b Bonds and labels linked to voluntary contributions
(8)Option 3.2.c Levy on products from the use of DSI
(9)Option 4 Enhanced technological and scientific collaboration and capacity-building
(10)Option 5 No benefits are shared from the use of DSI
(11)Option 6 One percent levy on retail sales of products using biodiversity (…)
53.Current discussions on DSI centre around two different models: a multilateral approach and the so-called hybrid approach. The two approaches have in common that they would not restrict access to DSI. However, the use of DSI would require benefit-sharing. Under the multilateral approach, benefits, generated, for example, through a levy on products from the use of DSI, would be deposited in a global fund that would also be open for voluntary contributions from all sources. Under the hybrid approach, benefit-sharing modalities would have to be negotiated with the country of origin of the genetic resource from which the DSI was obtained, provided the country of origin is known. Where DSI from genetic resources of several countries is used, benefits would have to be shared through a multilateral mechanism with the countries of origin of the genetic resources from which the DSI was obtained. Where no country of origin of the genetic resource from which the DSI has been obtained can be identified, benefits would have to be deposited, like under the multilateral approach, in a global fund. For both approaches, criteria for the disbursement of funds deposited in the global fund would have to be established. (…)
56.The ABS Expert Team may wish to:
(i)review the draft study on The role of Digital Sequence Information in the conservation and sustainable use of genetic resources for food and agriculture: opportunities and challengesin the light of comments and inputs received from the intergovernmental technical working groups;
(ii)recommend that the Commission request the Secretariat to: a.invite Members to submit information on domestic ABS measures applying to DSI and their actual or potential implications for the conservation and sustainable use of GRFA, including exchange, access to and the fair and equitable sharing of the benefits arising from their use, and to compile this information, for the information of the Commission;
b.continue monitoring developments regarding DSI in other fora, with a view to consider their potential implications, including potential opportunities and challenges for the Commission and its Members;
c.report regularly on these developments, including, as appropriate, prior to the next regular session of the Commission, for example through webinars; and
d.continue to hold virtual open-ended workshops on DSI, as appropriate, with a view to inform Commission Members and observers on recent technological and policy developments related to DSI. »
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Etude « Le rôle de l’information numérique sur les séquences dans la conservation et l’utilisation durable des ressources génétiques pour l’alimentation et l’agriculture : Opportunités et défis »
Résumé (passages en gras soulignés par nos soins) :
« This study discusses applications of digital sequence information (DSI) that are relevant to genetic resources for food and agriculture (GRFA), including DSI that is not derived from GRFA but nevertheless contributes to their identification, characterization, use, improvement and conservation. Applications of DSI are also fundamental to the characterization of other components of biodiversity for food and agriculture (BFA) and are important tools in efforts to make agriculture more sustainable.
Searches of CABI’s literature database, CAB Abstracts, which contains 10.9 million records, revealed many examples of publications that demonstrate the important contribution of DSI to improvement of crop production, control of emerging diseases and adaptation to climate change. The database searches revealed a rise in the number of publications on DSI from 20 000 in 2002 to 1 180 915 in 2022 (almost 12 percent of the records).
Scientific literature focusing on climate change adaptation and on improving the yields of the major global crops wheat, rice, maize, soybean, potato and chickpea was explored. Examples found included publications that addressed the following topics: discovery of candidate genes for improved abiotic stress tolerance in wheat; the contribution of DSI to progress on drought and heat tolerance in rice; use of DSI-based technologies to increase grain yield and starch content in maize; and DSI-assisted development of disease resistance and drought and salt tolerance in chickpea. These are clear examples of DSI playing an increasingly important role in research on climate change adaptation, crop production and plant health.
The increasing significance of DSI is further confirmed by the fact that the quantity of DSI available in public databases is growing exponentially: the content of the International Nucleotide Sequence Database Consortium (INSDC) database exceeded 9 petabytes in 2020. Analysis of the Science-based Approaches for Digital Sequence Information (WiLDSI) Data Portal demonstrates that data on biodiversity are generated globally and are being used extensively to help characterize it and to create innovative solutions to growing problems and threats.
However, making DSI available through public databases does not mean that it is accessible to everyone in the same way. Many countries face serious obstacles both in terms of access to DSI and in terms of its use. CABI received feedback from several of its member countries via its regional centres. The Bahamas, Brazil, China, Ghana, India, Kenya, Malaysia, Pakistan, Trinidad and Tobago, the United Kingdom and Zambia confirmed that they were using DSI, but most indicated that the capacities needed to generate it and make optimum use of it were not in place. However, the feedback from China confirmed that the country was in a good position with respect to the generation, storage, management and use of DSI.
There are currently several options on the table for how access to and use of DSI can be guaranteed while at the same time equitably sharing benefits associated with this use, especially with countries in need of capacity building and support in the field of GRFA conservation. There is some convergence towards a global, multilateral solution, while some countries are anticipating hybrid approaches that will incorporate both bilateral and multilateral systems for benefit-sharing. However, there is currently insufficient information available to carry out a cost–benefit analysis on these options, and discussions will continue on them during COP 15 in December 2022 (upcoming at the time of writing).
The key messages of this paper are:
1.There are many different existing and potential applications of DSI that are highly relevant to GRFA, including applications of DSI that is not itself derived from GRFA.
2.The current and potential applications of DSI show that its generation, storage, accessibility and use are fundamental to the characterization of BFA and are important to efforts to make agriculture more sustainable.
3.Access to and use of DSI face serious obstacles in many countries. There is an urgent need to address the root causes of these problems, which include lack of technical infrastructure, financial and human resources, educational and training opportunities, scientific collaboration, computing infrastructure, reliable electricity and high-speed internet, and may in the future possibly include prohibitive charges for database use.
4.There is a need for a regulatory environment that facilitates access to DSI and the fair and equitable sharing of benefits arising from its use. »
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