What is the Nagoya Protocol? How does it relate to microbiology?

Microbiology is an interconnected discipline, with researchers all over the world sharing samples and genetic data at an ever increasing pace. But how can we ensure that everyone can also benefit from any discoveries made? In this post, Katie Beckett from the UK Government’s Department for Business, Energy and Industrial Strategy (BEIS) tells us about the Nagoya Protocol, which aims to ensure that research benefits are shared in an equitable way.

Throughout human history, micro-organisms have played a critical role in the development of human society. From brewing beer to the Black Death, their impact has been significant, and microbiologists such as van Leeuwenhoek and Fleming have earned their place in history. Today, microbiology is a fundamental discipline in driving forward innovative research and new product development, such as producing new antibiotics to combat increasing drug resistance or studies into the effects of microbial communities on carbon and nitrogen cycles and resulting impacts on climate change. Microbiology is applied across a whole host of sectors and research areas with the micro-organisms themselves often being sourced from specialist collections around the world. In the first instance however, these genetic resources come from nature, existing in every part of the global biosphere – from the soil, atmosphere, and ocean, to hot springs and rock formations.

The protection and use of biological resources is of international concern. The Nagoya Protocol on access and benefit sharing (ABS), which entered into force in October 2014, is an international agreement that supplements the UN Convention on Biological Diversity (CBD). The agreement aims to ensure that benefits arising from research and development of genetic resources are shared in a fair and equitable way, thereby contributing to the conservation and sustainable use of biological diversity.

To date, 100 countries have ratified the Nagoya Protocol including the UK, which became a Party to the Protocol in May 2016. Under the Nagoya Protocol, Parties are obliged to take measures in relation to access to genetic resources and benefit sharing, with the aim of creating legal certainty for those seeking to access these resources for research and development programmes.

Through the adoption and implementation of effective access measures, countries can capture benefits that result from research and development of genetic resources over which they exercise sovereign rights. For this to be successful, legislation must facilitate access to the genetic materials, as without access there would be no opportunity for benefits. Benefits can be monetary or non-monetary with the conservation of biological diversity being of paramount concern. The concept of benefit sharing is not new, particularly for those working in academia and public institutions where results are routinely shared, papers are co-authored and knowledge is transferred between institutions and across geographical borders.

The Nagoya Protocol also requires Parties to establish compliance measures for users of genetic resources within their jurisdiction. In the UK, Nagoya Protocol obligations are implemented through Regulation (EU) No. 511/2014 on compliance measures for users. Regulatory Delivery, a directorate within the Department for Business, Energy and Industrial Strategy has been appointed by The Department for Environment, Food and Rural Affairs (Defra), the policy lead, as the competent authority responsible for UK implementation. Under the EU Regulation, users of genetic resources must ensure these resources have been accessed in accordance with the legislation of the provider country.

Over the past 18 months, Regulatory Delivery has focused on raising awareness and supporting compliance of UK users across a broad range of sectors including academia and pharmaceuticals, as well as cosmetics, food & beverage, bio-control, collections and others. There are also a number of tools available to support implementation and compliance, with the primary example being the Access and Benefit Sharing Clearing House (ABS-CH), an online platform acting as an information portal for details on country status, national contacts, legislation and administrative measures and examples of codes of conduct and best practices. In relation to measures for users in the EU, a cross-sector guidance document is available and sector-specific guidelines are currently under development to compliment this.

There will always be challenges when embedding new processes such as ABS into diverse areas of work as found within the microbiology community, but it is important not to lose sight of the overarching objectives, the conservation of biological diversity, and the opportunities that it presents both providers and users of micro-organisms.

Katie Beckett

Katie is the Enforcement Team Leader for Access and Benefit Sharing at Regulatory Delivery, The Department for Business, Energy and Industrial Strategy (BEIS). If you’ve any queries about how the Protocol might affect your work, please contact her via email.

Image credit: Harvepino/Thinkstock
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One Response to What is the Nagoya Protocol? How does it relate to microbiology?

  1. danleskien says:

    I fully agree with Katie Beckett’s observation that “there will always be challenges when embedding new processes such as ABS into diverse areas of work as found within the microbiology community”. All sectors face this challenge and need to consider appropriate strategies and tailor-made approaches to implement ABS.

    While developing and implementing policy frameworks or legislation for ABS per se is far from being an easy task, an additional challenge policy makers face in implementing the Nagoya Protocol is to comply with its “special considerations”:
    • The Protocol requires each Party to create “in the development and implementation of its access and benefit-sharing legislation or regulatory requirements […] conditions to promote and encourage research which contributes to the conservation and sustainable use of biological diversity, particularly in developing countries, including through simplified measures on access for non-commercial research purposes, taking into account the need to address a change of intent for such research.”
    • Parties shall “also pay due regard to cases of present or imminent emergencies that threaten or damage human, animal or plant health, as determined nationally or internationally. Parties may take into consideration the need for expeditious access to genetic resources and expeditious fair and equitable sharing of benefits arising out of the use of such genetic resources, including access to affordable treatments by those in need, especially in developing countries.”
    • Likewise, each Party shall “consider the importance of genetic resources for food and agriculture and their special role for food security.”

    The use and exchange of agricultural microorganisms present a wealth of opportunities for improvement of food and agricultural production systems, and for contributing to energy production and waste management in agriculture. Microorganisms also provide beneficial services in food production systems. E.g. for fermentation, as probiotics, for the production of chemicals of benefit to food production and the for understanding and surveillance of health hazardous microorganisms such as food toxins and food borne pathogens (see ftp://ftp.fao.org/docrep/fao/meeting/017/ak566e.pdf)

    In cognizance of the special nature of agricultural biodiversity, its distinctive features and problems needing distinctive solutions, FAO’s Commission on Genetic Resources for Food and Agriculture to develop Elements to Facilitate Domestic Implementation of Access and Benefit-Sharing for Different Subsector of Genetic Resources for Food and Agriculture (ABS Elements). In 2015, the FAO Conference welcomed the ABS Elements, which aim to assist governments considering developing, adapting or implementing ABS measures, to take into account the importance of genetic resources for food and agriculture (GRFA), their special role in food security and the distinctive features of the different subsectors of GRFA, while complying, as applicable, with international ABS instruments.
    The Commission’s work on ABS will intensify in 2018. The Commission agreed in February of this year to continue work on ABS for GRFA with the aim of raising the awareness of Commission Members, their diverse authorities involved in ABS and other stakeholders. The work should assist Members in reflecting in their ABS measures the importance and special role of GRFA for food security and the distinctive features of animal, plant, micro-organism and invertebrate genetic resources for food and agriculture.

    The Commission also agreed to produce “non-prescriptive explanatory notes describing, within the context of the ABS Elements, the distinctive features and specific practices of different subsectors of GRFA, to complement the ABS Elements.” The work on the Explanatory Notes started earlier this year with written submissions by Commission members, observers and stakeholders and will continue in early 2018 with an open-ended international workshop on ABS for GRFA, co-organized with the secretariats of the Convention on Biological Diversity (CBD) and the International Treaty on Plant Genetic Resources for Food and Agriculture. The workshop will provide outputs for subsequent elaboration into the Explanatory Notes addressing the different subsectors: animals, plant, invertebrate/microorganism GRFA.

    During the course of 2018, the Commission’s working groups, an expert group on micro-organism and invertebrate GRFA as well as the Commission’s ABS Expert Team will contribute to the finalization of a first draft of theExplanatory Notes, for consideration by the Commission at its next session.

    For more information: http://www.fao.org/nr/cgrfa/cgrfa-meetings/abs/en/
    Dan Leskien
    Senior Liaison Officer
    Commission on Genetic Resources
    for Food and Agriculture
    Food and Agriculture Organization
    of the United Nations

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