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.
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.
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.
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.
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).