Policy Lunchbox: Access and Benefit sharing through the Nagoya Protocol

Since 22 May 2016, the UK has been Party to the heftily-titled

‘Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity’

… or Nagoya Protocol, for short.

Despite the cumbersome name, the premise is simple and reasonable: if someone from one country uses a genetic resource from another (e.g. from plants, animals or microbes), then consent should be given and there should be an opportunity to share the benefits.

The responsibilities fall on many of us, whether we work in academic research labs or institutes, ex situ biological collections or in industry. In the UK, Regulatory Delivery (RD), a directorate within the Department for Business, Energy & Industrial Strategy, is the authority responsible for ensuring that UK legislation on Access and Benefit Sharing (ABS) is adhered to. Katie Beckett, the ABS Enforcement Team Leader at RD, joined us to give some background on the Nagoya Protocol and outlined the responsibilities of those involved in research & development.

Friends with benefits

The Nagoya Protocol came about from a desire to have an internationally-recognised legal framework for collaboration between the providers and users of genetic resources and associated traditional knowledge. Ultimately, resources should be shared in a transparent way that ensures sustainable use and conservation of biodiversity.

Integral to this noble pursuit is the requirement for Prior Informed Consent (PIC), which is given by the country providing the resource, and Mutually Agreed Terms (MAT), an agreement between user and provider on the benefits to be shared. ‘Shared benefits’ can cover many things, from technology transfer and training to royalty payments. Once agreed, the provider country may then generate an Internationally Recognised Certificate of Compliance (IRCC) to be enshrined within the ABS Clearing House, an international database that contains information from all the countries who are Party to the Nagoya Protocol (96 and rising).

Importantly, under current UK law, those using a genetic resource should inform Regulatory Delivery that a PIC and MAT are in place upon receipt of research funding and when a product is placed on the market.

Navigating the Nagoya Protocol

Whilst this might seem impenetrable at a first glance, thankfully there are many who are working to straighten out the landscape. The European Commission has already published general guidelines on following European ABS regulation and further sector specific guidance is in the pipeline, which will focus on areas including plant & animal breeding, biotechnology, pharmaceuticals and cosmetics.

In addition, organisations are coming out with their own best practice guidelines, such as those developed by the Microbial Resource Research Infrastructure (MIRRI). A number of these are accessible through the ABS Clearing House database.

As a starter for 10, Katie outlined some instances in which EU regulations will apply to researchers (found within the general guidelines):

• Research on a genetic resource leading to the isolation of a biochemical compoundMaintenance and management of a collection for conservation purposes
• Breeding programme to create a new plant variety based on naturally occurring plantsDescribing the phenotype of a genetic resource
• Genetic modification – creation of a genetically modified animal containing a gene from another speciesSupply and processing of relevant raw materials for incorporation into a product (no new research)

Where to next?

The discussion after Katie’s talk highlighted that many aspects of ABS regulation and implementation are at an early stage. Indeed certain aspects, such as the applicability to digital genetic sequence data, are still being discussed at the international level. So, how can you keep updated and get involved?

1. The UK Department for Environment, Food & Rural Affairs (Defra) convene an ABS Stakeholder Group, which a number of Learned Societies and other organisations are subscribed to. This is a key way to receive up-to-date information and communicate your views to the UK Government and European Commission.
2. The Royal Society of Biology is currently consulting the Biosciences sector on specific issues relating to the Nagoya Protocol. If you are a member of the RSB, or a related member organisation, keep an eye out for further details soon.
3. A UK University Forum is currently being established to support the Higher Education sector. Get in touch with Katie ([email protected]) for further details.

Further reading

The Linnean Society have prepared an excellent summary briefing of the Nagoya Protocol, which covers a lot of background and links to helpful tools and best practice guidance.

Smith et al. have published a freely-accessible article on the implications of the Nagoya Protocol for microbiology.

Policy Lunchbox is a joint initiative between the Biochemical Society, the British Ecological Society, the Microbiology Society, the Royal Society of Biology, Applied Microbiology International, and the Society of Experimental Biology. See the Policy Lunchbox organiser eventbrite page to keep up-to-date on new meetings.