Science has a critical role to play in international development and underpins progress in addressing global challenges in areas such as environment, agriculture, food security, health, and climate change.  In the natural sciences, the protection and sustainable use of biological diversity is a topic of international concern.  As such, international research and development partnerships work together to find solutions to these challenges through biotechnology and other means.

What is the Nagoya Protocol?

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 (plant, animal and microbial material) are shared in a fair and equitable way, thereby contributing to the conservation and sustainable use of biological diversity.

To date, 102 countries have ratified the Nagoya Protocol including the UK, which became a Party to the Protocol in May 2016. Countries party to the Nagoya Protocol are obliged to take measures in relation to access to genetic resources and benefit sharing, the aim being to provide  greater legal certainty for those utilising them in research and development.  Details of access and benefit sharing legislation that countries have put in place can be found on the ABS Clearing House, an online platform for sharing information relevant to the implementation of the Protocol.

Through the adoption and implementation of effective access regulations, provider 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, as without access there would be no opportunity for benefits.  However, the key to sustainable and inclusive international development is not only to deliver solutions but also to develop scientific capacity.  Therefore, benefits do not have to be monetary or commercial, but could refer to the transfer of knowledge, technology, training, and other initiatives addressing topics such as;

• Crop resistance
• Invasive species
• New medicines
• Conserving marine environments

What does this mean for UK researchers?

The Nagoya Protocol 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, which is part of the Department for Business, Energy and Industrial Strategy (BEIS), has been appointed as the competent authority responsible for UK implementation.

Where a researcher in the UK is planning to use a genetic resource in a research programme, they will need to put in place a process to comply with the due diligence obligations set out under the EU Regulation. This means that those accessing the material from a country will need to gather evidence to help demonstrate compliance. Individuals accessing genetic material should comply with applicable ABS legislation in place in the provider country, for example obtaining an access permit and agreeing mutually agreed terms (MAT) ensuring benefit sharing for any subsequent use.  Where the material is in scope of the Nagoya Protocol, a researcher in the UK who subsequently receives the material will need evidence of: (1) compliance with applicable ABS legislation and (2) that mutually agreed terms, which should set out how benefits will be shared in a fair and equitable way, have been put in place. Where the user of a genetic resource and / or associated traditional knowledge is in scope of the EU Regulation they would also be required to submit a declaration of due diligence to Regulatory Delivery at one or two checkpoints; upon the receipt of research funding or at the end of the research phase.  Users may also wish to gather (or retain) evidence to show where genetic material accessed is clearly out of scope.

We are here to support users of genetic resources in understanding whether their activities are relevant to the Protocol and legislation in the UK.  Do you have any questions on how the Nagoya protocol will affect your work?  If so, contact us.

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Katie Beckett is the Enforcement Team Leader for Access and Benefit Sharing at the Department of Business, Enterprise and Industrial Strategy.