Important terms
A best practice is an approach that has consistently shown results superior to those achieved with other means, and that is used as a benchmark. Best practice is used to describe the process of developing and following a standard way of doing things that multiple organisations can use. This concept is integrated into EU Regulation 511/2014. Associations of users or other interested parties may submit an application to the Commission to have a combination of procedures, tools or mechanisms, developed and overseen by them, recognised as a best practice in accordance with the requirements of this Regulation. When carrying out checks to verify whether users comply with their obligations, the competent authorities in the EU shall take into account that implementation by a user of a recognised best practice in relation to ABS may reduce that user’s risk of non-compliance. Currently, only the CETAF’s best practice has been recognised by the EU Commission. A selection of best practices and codes of conduct can be found on the page Downloads and links.
A ‘derivative’ is defined in the Nagoya Protocol as ‘a naturally occurring biochemical compound resulting from the genetic expression or metabolism of biological or genetic resources, even if it does not contain functional units of heredity’. Examples of derivatives include proteins, lipids, enzymes, flavonoids, essential oils and resins.
The term Digital Sequence Information (DSI) was first introduced in 2016 during the CBD negotiations, and has no internationally agreed-upon definition to date. A 2018 study, commissioned by the CBD, analyzed the components of the term:
- "Digital" refers to data stored electronically, such as on a computer or in data storage and not on paper;
- "Sequence" may refer to the order of nucleotides in nucleic acids or amino acids in proteins, although it is unclear if three-dimensional molecular structures are included under this terminology;
- "Information" that is obtained by processing data, such as cleaned DNA data from raw sequence data.
During a 2020 meeting of the Ad Hoc Technical Expert Group (AHTEG) on DSI on Genetic Resources, four possible DSI categories were considered:
- Narrow: DNA and RNA
- Intermediate: DNA, RNA, and proteins
- Intermediate: DNA, RNA, proteins, and metabolites
- Broadest: DNA, RNA, proteins, metabolites, and associated traditional knowledge, ecological interactions, etc.
The AHTEG agreed that the first three categories qualify as DSI, while the associated information in the fourth category would not qualify as such.
Due diligence can be defined as an investigation prior to signing a contract, or certain standards of care applying to an act. In the context of the EU Regulation on the implementation of the Nagoya Protocol, due diligence means that you did your very best to establish which Access and Benefit-Sharing conditions apply to the genetic resources you wish to access and use, and that you have fulfilled those conditions. Users of genetic resources have to be able to show that they have applied due diligence in fulfilling their benefit-sharing obligations stemming from access to and use of these resources.
Users acquiring PGRFA in a country that is a Party to the Nagoya Protocol and that has determined that PGRFA under its management and control and in the public domain, not included in Annex I to the ITPGRFA’s MLS, will also be subject to the terms and conditions of the SMTA for the purposes set out in the ITPGRFA, and shall be considered to have exercised due diligence.
In the context of the multilateral benefit-sharing mechanism for the use of DSI, those who upload DSI in genetic databases have to conduct due diligence that there are no restrictions on the publication of the DSI in the mutually agreed terms (MAT) that apply to access of the genetic resource from which the DSI was generated.
All users of genetic resources should exercise due diligence when accessing and using genetic resources. Due diligence declarations are submitted by users of genetic resources within scope of the EU ABS Regulation to demonstrate that they exercise due diligence.
Due diligence declarations are submitted at one or two stages: (1) at the stage of research funding in case of external funding, and (2) at the stage of final development of a project. Due diligence declarations can be submitted through the EU tool DECLARE, for which a user guide is available as a video and a PDF file. Templates for these declarations are provided in Annex II and III of the Commission Implementation Regulation (EU) 2015/1866.
An internationally recognised certificate of compliance (IRCC) is a certificate published on the ABS Clearing-House website by the provider country. It is based on a national permit or equivalent and contains information that can assist in monitoring the utilisation of genetic resources by users. An IRCC provides evidence that the user has accessed a genetic resource legally and in accordance with prior informed consent (PIC) and that mutually agreed terms (MAT) have been established, as required by the domestic ABS legislation or regulatory requirements of the provider country. Article 17 of the Nagoya Protocol states that the internationally recognized certificate of compliance shall contain the following minimum information when it is not confidential:
- Issuing authority;
- Date of issuance;
- The provider;
- Unique identifier of the certificate;
- The person or entity to whom prior informed consent was granted;
- Subject-matter or genetic resources covered by the certificate;
- Confirmation that mutually agreed terms was established;
- Confirmation that prior informed consent was obtained;
- Commercial and/or non-commercial use.
An overview of all published IRCCs is available on the ABS Clearing-House website.
A material transfer agreement (MTA) is a contract between a provider and a recipient of genetic material, specifying the terms and conditions of the transfer of such material. It covers the rights and obligations of the provider and the recipient, and specifies how benefits are to be shared. An MTA may govern the transfer of any genetic resource, whether in the form of whole organisms, seeds, embryos, cells and cell lines, plasmids, and DNA, but MTA may also be used for other types of materials, such as chemical compounds and even some types of software.
Three types of MTAs involving genetic resources are most common: those concerning transfer between academic or research institutions, transfer from academia to companies, and transfer from companies to academia. In the case of transfer from farming communities, these communities and/or the government authorities may be involved in concluding an MTA. The latter are also to be involved in the case of collection of genetic resources from natural areas.
The SMTA of the ITPGRFA is a particular MTA, which has the same standard conditions for every user and provider.
Mutually agreed terms (MAT) are the contractual arrangements concluded between a provider of genetic resources and a user. MAT may take the form of a material transfer agreement (MTA). The MAT define the conditions governing the use of genetic resources and benefit-sharing and may also include further conditions and terms for such utilisation as well as subsequent applications and commercialisation. MAT are reached between the two parties to a contract under private law (even if one of them is a government institution).
The establishment of MAT is to be regarded as the outcome of a negotiation between the Party providing genetic resources and the Party requesting access, be it an individual, a company, an institution, a community or a State. The term “mutually agreed terms” indicates that the conditions upon which utilisation of genetic resources is based should be the result of consensus. MAT typically incorporate elements of the PIC and, crucially, an understanding regarding the sharing of the benefits arising from the utilisation of the genetic resources. The elements to be agreed on in the MAT depend on the complexity of the proposed research and planned product development. The MAT does not dispense with the need to get PIC when this is required for access to and use of the particular genetic resource in question.
The National Focal Point (NFP) of a country provides information on legislation, rules and procedures governing access to genetic resources from that country. The NFP of a country is often the first contact point for a user wishing to access genetic resources from that country.
In the current context, prior informed consent (PIC) means approval for access to and utilisation of genetic resources by the authorities of the country where access is sought. Users should always check whether a specific country requires PIC. When PIC is required, the provider must be made fully aware of the planned utilisation and must explicitly agree with this before any utilisation of material takes place. In practice, this means that the competent national authority (CNA) of the provider country must be informed of and approve the planned research and utilisation. The user seeking access needs to provide all relevant information and ensure that the government or other responsible authority obtains this information.
Depending on national legislation in the country concerned, it may also be necessary to involve other stakeholders (such as local and/or indigenous communities managing farmers’ varieties or sharing knowledge on plants with medicinal value) in the PIC process. In such cases, obtaining PIC from those stakeholders will form a prerequisite for obtaining PIC from the relevant government authorities.
In other words, when required by national legislation, you need PIC from the CNA of a country for access to genetic materials and accompanying information. You may also need the consent of local and/or indigenous communities if you wish to collect farmers’ varieties or to use traditional knowledge about genetic resources, or from local authorities if you wish to collect genetic material from the wild, for instance wild crop relatives.
In the sense of the EU ABS Regulation (EU Regulation 511/2014), ‘provider country’ means the country of origin of the genetic resource or any (other) Party to the Protocol that has acquired the genetic resource in accordance with the Convention on Biological Diversity (CBD).
A collection that is registered under EU Regulation 511/2014 applies standardised procedures for exchanging samples of genetic resources and related information with other collections, and for supplying samples of genetic resources and related information to third parties for their utilisation in line with the CBD and the Nagoya Protocol; it supplies genetic resources and related information to third parties for their utilisation only with documentation providing evidence that the genetic resources and the related information were accessed in accordance with applicable ABS legislation or regulatory requirements and, where relevant, under mutually agreed terms. Users obtaining a genetic resource from a collection included in the register of collections within the European Union shall be considered to have exercised their obligation of due diligence with regards to collecting information.
The Standard Material Transfer Agreement (SMTA) is an MTA in a mandatory form for parties wishing to provide and receive material from the Multilateral System (MLS) of the ITPGRFA. It may not be changed or abbreviated in any way for the purpose of distribution of material placed in the MLS.
The SMTA is an agreement under private contract law between the particular providers and recipients but the Governing Body (defined in article 19 of the ITPGRFA), represented by FAO as the Third-Party Beneficiary, is recognised as having an interest in the agreements. This means that FAO can take appropriate action if it considers that a provider or recipient has not complied with the conditions of the SMTA.
There is no formal legal definition of traditional knowledge. In the absence of such a definition, the term traditional knowledge should be understood in the light of Article 8(j) of the CBD. It may thus be interpreted in an ABS context to mean knowledge associated with genetic resources held or developed by indigenous and local communities in the framework of their traditional lifestyles. Traditional knowledge does not have to be old to qualify as traditional. The term “traditional” here refers to the context in which the knowledge was generated.
The value of traditional knowledge of specific genetic resources might equal or exceed that of the genetic resources themselves. It follows that the provisions relating to Access and Benefit-Sharing also apply to specific information associated with genetic materials, indigenous knowledge or traditional knowledge. It should be noted that the Nagoya Protocol contains separate and equivalent articles on genetic resources and on traditional knowledge associated with genetic resources (e.g. in Articles 6 and 7; Articles 15 and 16), and that the SMTA of the ITPGRFA refers explicitly to available related information (Articles 4 and 5b).
In the context of the ABS instruments discussed here, “utilisation of genetic resources” means to conduct research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology. Examples of utilisation include research and development in the biochemical sector, plant breeding, and the research on genetic resources for cosmetic purposes.