The Nagoya Protocol applies to both those who gain access to genetic resources either directly from the country of origin and those who gain access indirectly through a third party.
There are four elements to consider when establishing if the genetic resource you are using falls under the Nagoya Protocol: Materials, Timeframe, Location, Activity.
All four elements need to be within scope for the regulations to apply. If only 3 of the 4 elements apply to your research then it will not come under the Protocol.
The Protocol applies to ALL genetic resources intended for research and development. There are a few exceptions which are listed below:
The Protocol applies to resources (or traditional knowledge) which was accessed:
- After 12 October 2014
- From secondary/intermediary sources after 12 October 2014 requiring that they meet all other criteria
Resources accessed before this date are not in scope even if they were not utilised until after that date.
The Protocol applies only to countries that have ratified the protocol. You can find more information at the Access and Benefit=Sharing Clearing House which includes geographical areas that are governed by specific ratifying countries.
If you are unsure, contact the relevant country’s ABS National Focus Point for confirmation.
If the origin country has not ratified the Protocol, then they are not in scope, however they may still have their own legislation you have to comply with
Genetic resources coming from areas beyond national jurisdiction (such as areas under the Antarctic Treaty System or the high seas) are not in scope.
If you are accessing genetic resources from multiple different countries, then you must consider each providing country as a separate entity.
If the resources are coming from a local indigenous community, it is best practice to establish mutually agreed terms for access with the community to avoid any issues.
The UK does not regulate its own genetic resources so if you are exclusively working with resources originating from within the UK then no further action is needed.
The definition of utilisation is ‘to conduct research and development on the genetic or biomechanical composition of genetic resources or their derivatives included through their application of biotechnology.’ This includes commercial and non-commercial research and may be basic or applied research.
The Protocol applies to all genetic resources intended for research and development. There are a few exceptions:
- The access material is used as testing/reference material for other test materials subjected to research and development
- Genetic resource that already has a known activity/purpose and the research being conducted is in relation to that activity (e.g. supply of aloe vera for the use in cosmetics)
- Material stored for describing phemotypic reference (botanical gardens) with no intention to be involved in research and development
- Genetic resource that already has a known activity and no new research will be carried out with it (e.g. supply of yeast for the brewing).
If your research is within scope then you will need to arrange certain agreements before starting your research using the genetic material. During your research you will be required to keep detailed records (specified in section below), and to submit Due Diligence declarations to DEFRA at specific points (see below).