Why do rules exist for the international exchange of genetic resources? What is Access and Benefit-Sharing? Which rules exist?
Why do rules exist for the international exchange of genetic resources?
What is access and benefit-sharing?
The term access and benefit-sharing (ABS) refers to access to and use of genetic resources and traditional knowledge associated with them, and the sharing of benefits stemming from this use between providers and users. As a result, free access to plants, animals and micro-organisms cannot be taken for granted or free nowadays, and benefits from the use of such resources need to be shared.
Benefit-sharing means that providers of genetic resources get a fair share of the benefits resulting from the use of their resources. Benefit-sharing can be monetary or non-monetary, and tailor-made or fixed. Non-monetary benefit-sharing may involve information exchange, technology transfer and capacity building. For further information see the Annex to the Nagoya Protocol and Article 13 of the ITPGRFA. Article 13 of the ITPGRFA states that facilitated access to plant genetic resources for food and agriculture included in the MLS constitutes a major benefit in itself. Various stakeholders attach different value to the fact that access to improved crop varieties for further research and breeding similarly constitutes a major non-monetary benefit.
The Nagoya Protocol explicitly refers to the utilisation of genetic resources held by indigenous and local communities, and Article 5 of the Protocol states that benefits from the utilisation of these resources should be shared in a fair and equitable way with the communities concerned, based on mutually agreed terms.
Which rules apply to ABS?
Access and benefit-sharing are regulated by the Convention on Biological Diversity (CBD), the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits arising from their Utilization, the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) and the Pandemic Influenza Preparedness (PIP) Framework. The Nagoya Protocol is implemented in the European Union through EU Regulations 511/2014 (the EU ABS Regulation) and 2015/1866 and through national legislation of the EU Member States, including the Netherlands.
The CBD and the Nagoya Protocol apply to all genetic resources, except human genetic resources. This includes plant, animal, microbial and viral resources, derivatives, and both terrestrial and aquatic species. The agreements apply equally to wild and domesticated species. All users should comply with the provisions of the CBD and the Nagoya Protocol as translated into national legislation, regardless of the type of use or the identity of the user.
The ITPGRFA only applies to plant genetic resources for food and agriculture; it is thus much more specific and has a more limited scope. This special ABS instrument establishes a Multilateral System (MLS) for Access and Benefit-Sharing involving a limited number of staple crops and forages. The PIP Framework only applies to influenza viruses with human pandemic potential. It is an international ABS instrument that aims to improve pandemic influenza preparedness and response by establishing a system for 1) the sharing of H5N1 and other influenza viruses with human pandemic potential and 2) access to vaccines and sharing of other benefits. For all other genetic resources (of plant, animal, microbial or viral origin), the provisions of the CBD and the Nagoya Protocol concerning ABS will generally apply, unless a Party has decided to apply the ITPGRFA for regulation of access to their plant genetic resources for food and agriculture.
The Convention on Biological Diversity
The Convention on Biological Diversity (CBD) entered into force in 1993. Its objectives are the conservation of biological diversity, the sustainable use of its components, and the fair and equitable sharing of the benefits arising from the utilisation of genetic resources. The CBD covers all ecosystems, species, and genetic resources, except human genetic resources. It lays down general rules to regulate access to genetic resources and their use, and rules for the sharing of benefits between providers and users, stemming from this use.
Article 15 of the CBD states that “… the authority to determine access to genetic resources rests with the national governments and is subject to national legislation ….” and that “Access, where granted, shall be on mutually agreed terms” and “subject to prior informed consent of the Contracting Party providing such resources, unless otherwise determined by that Party.” The Contracting Party is the government of the country where the genetic resources are to be found.
The Nagoya Protocol
The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits arising from their Utilization was adopted under the CBD in 2010 and entered into force in October 2014. The objective of the Nagoya Protocol is the fair and equitable sharing of benefits arising from the utilisation of genetic resources and associated traditional knowledge. It is aimed at providing a transparent legal framework for access and benefit-sharing, supporting compliance by both providers and users of genetic resources.
The Nagoya Protocol rests on three main pillars: measures concerning access, benefit-sharing, and user compliance. The access pillar leaves it to countries that have adopted the Nagoya Protocol to either regulate access or not. If countries decide to regulate access, certain criteria apply. The agreed elements of benefit-sharing should be incorporated in mutually agreed terms (MAT). The user compliance pillar obliges all Contracting Parties to the Protocol to ensure that only legally acquired genetic resources and associated traditional knowledge are utilised under their jurisdiction.
The CBD and Nagoya Protocol define the situations under which the ABS provisions apply. In this context, utilisation of genetic resources means research and development work on the genetic and/or biochemical composition of genetic resources, through the application of biotechnology among other means (Article 2 of the Nagoya Protocol). Biotechnology as defined in Article 2 of the CBD means any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use. A derivative has been defined in article 2 of 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. In other words, the current definition of utilisation covers research and development on both the genes and biochemical compounds contained in the acquired genetic resources.
The International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA), which entered into force in 2004, deals specifically with plant genetic resources for food and agriculture (PGRFA). It is a specialised ABS instrument.
The core of the ITPGRFA is the multilateral system (MLS), a defined shared pool of genetic resources of 64 important crops and forages. Genetic resources included in the MLS are available for research, breeding and training for food and agriculture purposes, but not for other purposes. The benefits arising from their use are to be shared through the exchange of information, access to and transfer of technology, capacity-building, and the sharing of the benefits arising from commercialisation. Access is provided on the basis of a standard material transfer agreement (SMTA) with fixed conditions.
If the ITPGRFA applies to a certain genetic resource, the provisions of the Nagoya Protocol are not applicable. The placement of collections in the MLS means that the ABS provisions of the ITPGRFA apply to all exchanges and food/feed uses of such collections, as embodied in the SMTA.
The MLS covers the 64 important crops and forages listed in Annex I of the ITPGRFA, if the genetic resources are under the management and control of the Contracting Parties and in the public domain, or have otherwise been placed in the MLS by other holders of plant genetic resources on a voluntary basis. Crops not listed in Annex I cannot be included in the MLS. However, the terms and conditions of the SMTA governing access to the genetic resources in the MLS can also be used to provide access to these genetic resources on a voluntary basis. In fact, this has become a well-established practice amongst many European gene banks, including the Centre for Genetic Resources, the Netherlands (CGN).
The PIP Framework
The Pandemic Influenza Preparedness (PIP) Framework is an international instrument that aims to improve pandemic influenza preparedness and response by establishing a system for 1) the global sharing of H5N1 and other influenza viruses with human pandemic potential and 2) access to vaccines and sharing of other benefits. It was negotiated by Member States of the World Health Organization (WHO) and entered into force on 24 May 2011.
Currently, the PIP Framework does not have the same status under the Nagoya Protocol as under the EU ABS Regulation. The PIP Framework is not yet recognised as a specialised international access and benefit-sharing instrument under the Nagoya Protocol, as the criteria for recognition of these instruments are still under discussion. In the future, the PIP Framework may be accepted as a specialised instrument. In that case, genetic material acquired under both SMTA1 and SMTA2 will fall outside the scope of the Nagoya Protocol.
In the EU ABS Regulation, the PIP Framework is recognised as a special international ABS instrument (preamble 10). This means that material covered by the PIP Framework does not fall within the scope of the EU ABS Regulation.
EU Regulation 511/2014 for the purpose of implementation of the Nagoya Protocol and EU Implementing Regulation 2015/1866
The European Union adopted Regulation 511/2014 for the purpose of implementation of the Nagoya Protocol in the EU in 2014. This Regulation applies to all use of genetic resources in the EU and includes obligations on users of genetic resources in the EU. It entered into force in October 2014.
A wide range of actors in the European Union, including academic researchers and companies from different business sectors (including plant and animal breeding, bio-control, pharmaceutical, cosmetics, and the food and beverage industries) use genetic resources for research and development purposes. Some also use traditional knowledge associated with genetic resources.
The EU Regulation on ABS includes the obligation on all users of genetic resources to exercise due diligence (that is, to show that they did their utmost best to comply with legal requirements) in ensuring that genetic resources and associated traditional knowledge are accessed in compliance with applicable legal requirements, and that benefits are fairly and equitably shared on mutually agreed terms. To that end, all users of a genetic resource will need to seek, keep, and transfer to subsequent users the information relevant to ABS.
The EU Regulation obliges users to declare that they complied with the due diligence obligation. Member States should check whether users comply with their obligations under this Regulation and ensure that infringements of this Regulation by users meet with the necessary sanctions.
Associations of users may apply for recognition of a combination of specific procedures, tools or mechanisms as a “best practice”, to facilitate compliance with the Nagoya Protocol at an affordable cost and with a high level of legal certainty.
The EU Regulation applies directly to and in all Member States of the EU, and as such to all institutes, companies and citizens using genetic resources. The Regulation does not apply to genetic resources falling under specialised international ABS instruments (the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) and the Pandemic Influenza Preparedness (PIP) Framework).
EU Implementing Regulation 2015/1866 lays down detailed rules concerning the implementation of Articles 5, 7 and 8 of Regulation (EU) No 511/2014, which refer to the register of collections, the monitoring of user compliance, and to best practices.
Many countries have established national legislation and/or regulatory measures to implement the international ABS agreements at the national level. This is also the case in the Netherlands, where EU Regulation 511/2014 for the purpose of implementation of the Nagoya Protocol applies. The Netherlands has implemented this EU Regulation through the Nagoya Protocol (Implementation) Act.
This bill establishes which agency monitors the compliance of users of genetic resources in the Netherlands with the relevant regulations, and the sanctions that will apply in the case of non-compliance. It will not lay down specific rules governing access to genetic resources occurring in situ in the Netherlands. However, other legislation may apply to access to genetic resources, such as species or habitat protection.
In general, the provisions of the above-mentioned international agreements are not binding in countries that have not ratified them, and these countries are not entitled to the rights established under these agreements. Similar considerations apply to rules concerning access and benefit-sharing applied by those countries that may not necessarily be in line with the provisions of the international agreements.