Guest Blog | The Nagoya Protocol: Sharing the benefits of R&D for the future of global biodiversity

Jane Collins is the Enforcement Team Leader for Access and Benefit Sharing at the Office for Product Safety and Standards, part of the UK Government’s Department for Business, Energy and Industrial Strategy

Humans have long explored global biodiversity in search of new natural compounds that can be used to benefit human health. Today, researchers in the bioindustry sector continue to explore biodiversity for treatments to various human health conditions and diseases. In some cases, this research may involve the use of components of biodiversity accessed from overseas or engagement with indigenous communities to learn from their associated traditional knowledge. Researchers who undertake this work often need to gain the appropriate permission to access these valuable resources under national laws in the provider country, and also negotiate terms of use. The terms of use may also influence how these resources can be used further along the value chain, for example by those involved in product development. The terms of use may include benefit sharing agreements, which may be negotiated to support capacity building, the protection of biodiversity or sustainable development in the provider country. Users of this biodiversity or traditional knowledge in the UK are also required to demonstrate that they have exercised due diligence and complied with provider country laws, where applicable, to the relevant UK authorities.

The Convention on Biological Diversity and the Nagoya Protocol

The Convention on Biological Diversity (CBD) came into effect in 1993 and was developed in recognition of the value of biodiversity to human society and the threats it faces from climate change and habitat degradation. The CBD has three main objectives; 1) to conserve biodiversity, 2) to ensure the sustainable use of biodiversity and 3) to ensure the fair and equitable sharing of benefits arising from the utilisation (research and development into genetic and / or biochemical composition) of genetic resources (plants, animals, microbes and other material of non-human origin of actual or potential value). To supplement this third objective, the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation, or Nagoya Protocol for short, came into force on 12^th October 2014.

The Nagoya Protocol aims to provide more predictable conditions for access to genetic resources and associated traditional knowledge, and to monitor their utilisation. This is to ensure that these resources are accessed legally and, where agreed, the benefits arising from their utilisation are shared fairly. The Nagoya Protocol also increases transparency and trust between providers of genetic resources and users (those conducting utilisation). To further support the first and second aims of the CBD, negotiations between providers and users should consider their sustainable use, and ways in which benefits can contribute to the protection of biodiversity or sustainable development. One hundred and thirty countries are party to the Nagoya Protocol at the time of writing, with more countries ratifying every year.

What is access and benefit sharing and why does this matter for the bioindustry sector?

‘Users’ of genetic resources are defined as ‘any natural or legal person that utilises genetic resources or traditional knowledge associated with genetic resources’.  Users may include the individual (e.g. researcher) utilising the genetic resource or the organisation (e.g. university, research institute, company etc) to which the individual is affiliated with and / or employed by. Alternatively, both may be jointly considered as the user and therefore hold joint responsibility for compliance with applicable ABS measures. The entity considered as the ‘user’ will depend on a case-by-case basis. 

Every researcher is obliged to abide by provider country laws regarding utilisation of their genetic resources. Historically, many provider countries struggled to monitor the utilisation of their genetic resources once they had left the country. The Nagoya Protocol addresses this by requiring party countries to implement compliance laws. In the UK, compliance measures for the Nagoya Protocol are contained in the UK Access and Benefit Sharing (ABS) Regulation[1]. The Regulation require users to exercise due diligence to ascertain that genetic resources and any associated traditional knowledge have been accessed in line with provider country ABS legislation or regulatory requirements. The UK ABS Regulation is triggered when a researcher accesses (after the 12^th October 2015) genetic resources from a provider country that is party to the Nagoya Protocol and has access legislation covering the genetic resources being utilised, that are not already governed by specialised international ABS instruments (e.g. the Pandemic Influenza Preparedness Framework and the International Treaty on Plant Genetic Resources for Food and Agriculture).

In order to comply with the UK ABS Regulation, a researcher planning to access genetic resources from overseas for utilisation within the UK must first check whether the provider country has applicable ABS measures in place. This information, together with contact details for the relevant, provider country authorities, can usually be found on the ABS Clearing House. If necessary, users should contact the relevant authorities in the provider country to confirm whether national ABS measures have been implemented, whether their project is in scope and if so, how to comply. If relevant access measures are in place, and the users project is within scope, the user must acquire Prior Informed Consent (PIC) and negotiate Mutually Agreed Terms (MAT), or equivalent. In most instances, this must take place prior to access, but there are provisions in the regulation to have obligations delayed for work aiming to combat public health emergencies. If genetic resources are obtained from intermediaries, it is the responsibility of the user to ensure that appropriate PIC / MAT / equivalent documentation are in place for their intended use, and / or to renegotiate the PIC / MAT / equivalent with the provider country authorities if necessary. Once these documents have been acquired, utilisation can be carried out under the terms agreed with the provider country. At the stages of receiving research grant funding and product development, the user must declare their due diligence to the relevant authorities in the country where utilisation is taking place. To submit a due diligence declaration in the UK, users must complete a due diligence declaration form which can be downloaded from the Office for Product Safety and Standards (OPSS) webpage and send it to DEFRA ([email protected]). The provider country will be notified about the declaration and will be able to review it against the original PIC and MAT that they provided to check that the resources are being used under the agreed terms. It is also important to remember that even if a genetic resource is out of scope of the UK ABS Regulation, the provider country may still have ABS legislation in place that the user must comply with.

UK Authorities

The Departments for Environment, Food and Rural Affairs (DEFRA) and Business Energy and Industrial Strategy (BEIS) are responsible for implementing the Nagoya Protocol in the UK. The Office for Product Safety and Standards (OPSS), part of BEIS, acts as the Competent National Authority (CNA) and works directly with businesses, research organisations and other institutions to support understanding and compliance. For further information, please go to www.gov.uk/abs. If you have any questions or would like to discuss your specific case with us, please don’t hesitate to get in touch using the following address: [email protected]    

The OPSS is hosting a webinar introducing the Nagoya Protocol for the UK pharma and biotech sectors on 14 July, 10am. You can register here. 

Legislation and further reading material:

Convention on Biological Diversity. Text of the Nagoya Protocol. Available from: https://www.cbd.int/abs/text/ [Accessed 16^th April 2021] 

Eur-Lex. Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014 on compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union (Text with EEA relevance). Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32014R0511 [Accessed 16^th April 2021]

ABSCH. The Access and Benefit Sharing Clearing House. Available from: https://absch.cbd.int/ [Accessed 16^th April 2021]. 

Dias, D.A., Urban, S. and Roessner, U., 2012. A historical overview of natural products in drug discovery. Metabolites, 2(2), pp.303-336.

Pushpangadan, P., George, V., Ijinu, T.P. and Chithra, M.A., 2018. Biodiversity, Bioprospecting, Traditional Knowledge. Sustainable Development and Value Added Products: A Review. Journal of Traditional Medicine & Clinical Naturopathy, 7(1), pp.1-7.

Pushpangadan, P., Ijinu, T.P., Dan, V.M. and George, V., 2015. Trends in bioprospecting of biodiversity in new drug design. Pleione, 9(2), pp.267-282.

[1] ‘UK ABS Regulation’ means legislation implementing the requirements of the Nagoya Protocol (on Access and Benefit Sharing (ABS)) in the UK, comprising The Nagoya Protocol (Compliance) (Amendment) Regulations 2015 (1691) and retained EU direct legislation (Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014 and Commission Implementing Regulation (EU) 2015/1866 of 13 October 2015), as amended by the Nagoya Protocol (Compliance) (Amendment) (EU Exit) Regulations 2018 (SI 2018/1393) and the Environment and Wildlife (Legislative Function) (EU Exit) Regulations 2019 (SI 2019/473)).