Protecting Inventions while preserving biodiversity

What does Nagoya Cover in the UK?

 

For researchers working on non-human genetic resources in the UK, it is important to comply with UK ABS regulations. Similar regulations apply to research carried out in the EU, but not in the US which is not a party to Nagoya.

 

The UK ABS Regulations apply to any user conducting R&D on physical non-human genetic resources and/or associated traditional knowledge (aTK) accessed on or after 12^th October, 2015, from a country that is both party to the Nagoya Protocol and has ABS legislation in place. To comply with the law the user of the genetic resource and / or aTK is responsible for undertaking due diligence and submitting a due diligence declaration as required. It is important to note that the UK does not assert its Nagoya rights, so if the non-human genetic resource was sourced from the UK or before 12^th October, 2015, then no due diligence declaration is required. However, if the genetic resource is taken from material that originates from outside the UK (even if it was procured from a UK supplier) within the last decade then there is a strong possibility that Nagoya applies.

 

By way of example, compliance with UK ABS Regulations would apply if a researcher:

 

• goes to a country having Nagoya ABS regulations in place and procures material containing non-human genetic for R&D in the UK;
• obtains non-human genetic resources from imported goods - such as meat, fruit or vegetables – grown in a country having Nagoya ABS regulations in place, even if the goods were purchased in the UK;
• accesses samples of non-human genetic resources from a UK or foreign biobank or microorganism depositary that includes material deposited after 12^th October, 2015 and originating from a country having Nagoya ABS regulations in place.

 

These are non-exhaustive possible cases where UK ABS regulations apply and where there is an obligation to provide a due diligence declaration.

 

The Office for Products and Safety Standards (OPSS) has provided a complete self-assessment tool to help researchers determine whether they need to comply with UK ABS regulations: https://www.gov.uk/guidance/abs

 

Failure to comply with UK ABS regulations is a criminal offence, so it is important to understand whether R&D into non-human genetic resources falls within the scope of Nagoya compliance obligations, especially before committing to lengthy and expensive product development.

 

What is the future for Nagoya?

 

The current scope of Nagoya compliant regulations in many countries applies only to procurement and use of physical material. Certainly, within the UK the law is interpreted to apply only to physical samples containing a genetic resource. However, in an age of bioinformatics and increasing use of ‘-omics’ based machine learning technologies there is a drive to extend the scope of Nagoya to include so called digital sequence information (DSI). This would mean that mere use of sequence data associated with a genetic resource could land R&D activities within scope of Nagoya and place ABS obligations on academics and companies working within the fields of biotech, therapeutics, pharmaceuticals, food and agritech.

 

In May 2024, the World Intellectual Property Organisation (WIPO) agreed in a diplomatic conference to conclude wording for a treaty on intellectual property, genetic resources and aTK. The wording of the treaty includes a requirement for a disclosure of the country (or countries) of origin where the claimed invention is based on genetic resources and/or aTK. This disclosure would place an obligation on patent applicants to make public within their application where they sourced genetic resources used in the claimed invention. The intention of this measure being to facilitate the original objectives of ABS legislation.

 

There is a strong movement internationally to set up multilateral benefit sharing mechanisms that place databases containing DSI behind paywalls. This would simplify the process of ABS and make it easier to levy funds to support biodiversity measures internationally. Whilst on one side researchers have pushed back arguing that this hinders free access to information needed for developing new products and medicines, the counter argument is that monetary benefits of big biotech and big pharma’s exploitation of natural resources have not been shared equitably with many of the poorest countries that bear the burden of protecting the world’s greatest regions of biodiversity.   

 

It seems likely in the future that there will be a need to comply with even more stringent ABS regulations at least within the UK and EU in the future. So, understanding clearly the current requirements for due diligence and building them into technology development, IP and R&D workflows is essential for anyone using non-human genetic resources now and in the future.

 

Keltie attorneys can help advise on UK ABS regulatory compliance and how this interfaces with IP strategy. Please contact dev.crease@keltie.com for further information.