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[For the Dutch version, see the ABS Focal Point website.] Welcome to the fifth ABS Focal Point newsletter! In this newsletter we refer to the current discussion on ABS aspects of digital sequence information (DSI), look at past and upcoming inspections on compliance with the EU ABS Regulation in the Netherlands, highlight a few sections of the revised EU Guidance regarding service providers and provider countries, and announce a EU ABS networking event. This newsletter contains:
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Digital Sequence Information (DSI) on genetic resourcesIn view of the increasing use of ‘digital sequence information’ (DSI) on genetic resources, the question was raised whether the use of this information should also be subject to access and benefit-sharing obligations. A range of scenarios of how to deal with access to and benefit-sharing from the use of DSI have been developed, and the ABS Competent National Authority of the Netherlands is interested in hearing the experiences and opinions of Dutch stakeholders. In the decades since the Convention on Biological Diversity (CBD) was agreed upon in 1992, technological developments in life sciences have been rapid, and genomic information is being used more and more in innovation and product development, in addition to or even instead of genetic resources. In the context of the Nagoya Protocol on Access and Benefit-Sharing, some countries fear that this increasing use of genomic information will lead to decreased benefit-sharing from the use of genetic resources. As a result, the question was raised whether the use of genomic information, similar to the use of genetic resources, should also be subject to access and benefit-sharing obligations, and an intense international discussion has started. In this discussion, genomic information (and sometimes other information on genetic resources as well) is usually referred to as ‘digital sequence information’ (DSI), although the term DSI is not clearly defined. Presently, opinions diverge widely, and this divergence in opinions has become a major barrier to finding agreement on DSI and other aspects of the CBD and other international agreements. In general, consensus exists that access to and use of DSI is extremely important for the conservation of biodiversity and sustainable development. However, views diverge on whether access to DSI and the sharing of benefits from its use are currently fair and equitable. Countries also have different opinions on whether and how access to DSI and benefit-sharing from its utilisation should be regulated. Discussions are taking place, mainly under the framework of the CBD and the Nagoya Protocol, but also in other international agreements and organisations. In the meantime, some countries have included DSI in their domestic access legislation. A range of scenarios of how to deal with access to and benefit-sharing from the use of DSI have been developed. An overview can be found on the website of the CBD. The ABS Competent National Authority of the Netherlands (Ms Kim van Seeters; k.vanseeters@minlnv.nl) is interested in hearing the experiences of Dutch stakeholders with DSI and their opinions on the DSI scenarios that have been developed, if possible before 25 May. |
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Inspections on EU ABS Regulation compliance in the NetherlandsThe Netherlands Food and Consumer Product Safety Authority (NVWA) has been monitoring compliance with the EU ABS Regulation (Regulation (EU) 511/2014) in the Netherlands since the Nagoya Protocol Implementation Act came into force in 2016. Users of genetic resources are checked per sector, unless reports of individual cases of non-compliance are received from third parties, for example provider countries. After physical inspections of the Plant breeding sector, the Public research sector and the Food and feed sector were digitally inspected. During these inspections, the NVWA examined whether organisations or companies use material that is in scope of the EU ABS Regulation and how operations within these organisations or companies are structured to meet the obligations arising from the EU ABS Regulation. The results of these digital inspections were published on the NVWA website (in Dutch). No cases of non-compliance were found to date. However, it should be noted that the use of specific genetic resources was not yet examined in detail. No reports of non-compliance with the Regulation were received from third parties either. In 2021, the Cosmetics sector and Animal breeding sector will be contacted for digital inspections. In the following years, the Pharmaceutical sector and other biotechnology companies will follow. Using the insights obtained from all the sectors, an approach will be developed for the continuation of monitoring. For questions about the monitoring of the EU ABS Regulation in the Netherlands, please contact Linda Wassink-de Ligt (L.wassink@nvwa.nl). |
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The contribution of ABS to the Sustainable Development GoalsHow does access and benefit-sharing contribute to the UN Sustainable Development Goals? A new compendium examines case studies to answer this question. In a webinar on April 14th, the Union for Ethical Biotrade (UEBT) presented the compendium and hosted a panel discussion on three of the compendium’s cases. The compendium, titled ‘The contribution of Access and Benefit-Sharing (ABS) to the Sustainable Development Goals’, is the result of a research project on how access and benefit-sharing (ABS) can contribute to the conservation and sustainable use of biodiversity, as well as to the United Nations Sustainable Development Goals (SDGs). The compendium examines eleven cases, describing the context in which ABS partnerships were developed in Asia, Africa, Latin America, including actors involved, the resources accessed and the process which led to ABS arrangements. Section II of the compendium provides key findings and conclusions, based on information gathered from the cases. One of the case studies is on the cosmetics company Natura, which developed cosmetic products based on Amazonian biodiversity in Brazil. Natura established long-term partnerships with communities in the Amazon region for the development and sourcing of cosmetic ingredients: Andiroba oil and Murumuru butter. Mutually agreed terms (MAT) were reached between Natura, the Brazilian government and three local community organisations to determine what monetary and non-monetary benefits would be shared. It was concluded that the ABS agreement contributed to the wellbeing and livelihood of the local communities (SDG 1, 8), gender equity (SDG 5), conservation projects and the enhancement of the supply chains (SDG 15), empowerment of local people (SDG 10) and capacity-building through environmental education and management trainings (SDG 4). The webinar on April 14th introduced the research project and discussed the case studies, their key components, general lessons learned and good practices. The panel discussion stressed the importance of long-term partnerships, community engagement and communication between actors involved. The compendium has been published on the ABS Clearing-House. A recording and the presentation slides of the webinar are also available. |
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Does the work of service providers fall under the EU ABS Regulation?It is common practice that some research and development activities are carried out by service providers. Examples are DNA or protein sequence determination, DNA or protein synthesis and investigation of bioactive compounds and extraction methods. Performing these activities could make the service providers users in the meaning of the EU ABS Regulation (Regulation (EU) 511/2014), which would mean that they have to fulfil the due diligence obligations of the EU ABS Regulation. However, under certain conditions it could be agreed between service providers and service requestors that these due diligence obligations are the responsibility of the service requestor only. If the following conditions are met and are explicitly set out in the service agreement, it is the service requestor that is considered to be the user in the meaning of the EU ABS Regulation, and it is the service requestor who has to fulfil the due diligence obligations:
However, if one or more of these conditions are not met, it is possible (depending on the activities carried out) that the service provider is to be considered a user and that the service provider has to fulfil the due diligence obligations of the EU ABS Regulation. For more information, see section 3.5.2 of the Guidance. |
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Provider countries: unknown country or no access measures?Occasionally, the provider country of a certain genetic resource is unknown. Or the provider country of a genetic resource is a Party to the Nagoya Protocol, but has not established applicable access measures. What should you as a user of these genetic resources do in these cases? What if the provider country is unknown? If, despite best efforts being applied, the provider country cannot be identified, it is not possible to determine what, if any, national legislation or regulations apply. As the EU ABS Regulation (Regulation (EU) 511/2014) does not forbid the utilisation of genetic resources of unknown origin, utilisation may take place in such circumstances. However, if the provider country of the genetic resources is identified later, for example because new information has become available, the user obligations of the EU ABS Regulation do apply. So, if required by the now identified provider country, the user must obtain prior informed consent (PIC) and mutually agreed terms (MAT), or discontinue utilisation. In short: although the EU ABS Regulation allows utilisation of genetic resources from an unknown provider country, there is more legal certainty if only genetic resources of known origin are used and the requirements of the provider country are complied with. For more information, see section 3.3 of the Guidance. What if a provider country is Party to the Nagoya Protocol, but has not established any access measures? Some provider countries that are Party to the Nagoya Protocol may not (yet) have established applicable ABS access measures. The EU ABS Regulation (Regulation (EU) 511/2014) only applies to genetic resources from provider countries which are Parties to the Nagoya Protocol and have established applicable access measures. If no access measures have been established, the use of these genetic resources is outside the scope of the EU ABS Regulation. You may check the ABS Clearing-House (ABSCH) website to see if a provider country has established applicable access measures. However, do note that if the ABSCH does not contain information on access legislation, this does not necessarily mean that the country does not have access legislation. Users of genetic resources are recommended to contact the country’s National Focal Point for more information. Names and contact details of National Focal Points of most Parties to the Nagoya Protocol are available on the ABSCH. For more information, see sections 2.1.2 and 3.2 of the Guidance. |
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EU ABS Networking Event (June 14, 2021)On Monday, June 14, 2021 from 14.00-16:00 CEST, the German Nagoya Protocol HuB will be co-hosting an online EU ABS Networking Event together with the European Marine Biological Resource Centre, the Union for Ethical Biotrade, ABS-int, the Dutch ABS National Focal Point (hosted by Wageningen University and Research), and the Natural History Museum London. Since 2014, actors across the European Union have been hard at work figuring out how best to support users of genetic resources in their sectors or regions with access and benefit sharing (ABS) requirements. The organisers of the networking event would like to take a step back and ask “What has been done? Is it working? What still needs to be done?” This online event will bring different actors from across the EU together to reflect on “capacity building for users” — gaps and ways forward into the future. |