The Nagoya Protocol has been in force in the UK since October 2015 and obliges users of genetic resources and traditional knowledge associated with genetic resources to comply with due diligence requirements before its ‘utilisation’. There is also an obligation to make a due diligence declaration on receiving research funding and at product launch. The legislation carries penalties for breach and alarmingly, users may be ordered to discontinue their work if the relevant documentation is not in place. This legislation is relevant to the pharmaceutical, biotechnology, food and feed, animal breeding, plant breeding, and cosmetic sectors.
The UK Office for Product Safety & Standards (OPSS) has indicated that it will start to carry out audits on research institutions and industry this year. Currently, digital sequence information does not fall within the scope of the Nagoya Protocol, but it is likely that benefit sharing legislation will be put in place.
One main challenge is that the legislation is unclear.
What is the origin of the Nagoya Protocol?
In 1994 the United Kingdom ratified the Convention on Biological Diversity, an international piece of legislation with 3 main objectives:
- the conservation of biological diversity;
- the sustainable use of the components of biological diversity; and
- the fair and equitable sharing of benefits arising out of the utilisation of genetic resources.
The Nagoya Protocol applies to the third objective.
Provider and user country obligations
Over 120 countries are signed up to the Nagoya Protocol and each country has the power to regulate access to genetic resources in their territory. The provider country may make access subject to prior informed consent and may require benefits from their use to be shared on mutually agreed terms. The provider country must provide legal certainty, clarity and post its relevant legislation in ABS Clearing House1. The UK government has chosen not to exercise sovereign rights for accessing its genetic resources under the Nagoya Protocol. Therefore there is no requirement to carry out due diligence for any utilisation of UK genetic resources for the purposes of the Nagoya Protocol.
The user country (in this case the UK) must take effective measures to ensure that genetic resources utilised within the UK have been accessed in accordance with the rules of the provider country. Therefore the key is to check the requirements of the provider country.
Does the Nagoya Protocol apply to you?
The Nagoya Protocol applies, and you must to adhere to the laws of the provider country, if you are you ‘utilising’ a ‘genetic resource’.
‘Genetic Resource’ is defined as ‘any material of plant, animal, microbial or other origin containing functional units of heredity of actual or potential value’.
‘Utilising’ is defined as ‘to conduct research and development on the genetic and/or biochemical composition of genetic resources including through the application of biotechnology’.
NOTE: Human genetic resources fall outside the Nagoya Protocol and the Nagoya Protocol applies only to genetic resources accessed after October 2015.
What are your obligations?
Users are required to seek, keep and transfer to subsequent users, documentation in relation to the below, before utilisation of a genetic resource or associated traditional knowledge:
- the date and place of access of genetic resources
- the description of the genetic resources utilised
- the source from which the genetic resources were directly obtained
- the presence or absence of rights and obligations relating to the access and benefit sharing and obligations regarding subsequent application and commercialisation
- access permits, where applicable
- prior informed consent and to agree to mutually agreed terms before ‘utilisation’ takes place
- make due diligence declarations to Defra upon receipt of research funding and at the final stage of development of a product
Obtaining an internationally-recognised certificate of compliance as well as mutually agreed terms will remove the need for some of the documentation.
Users are required to keep the documents for 20 years after the end of the period of utilisation.
What happens in a Public health emergency?
A short extension is allowed in fulfilling due diligence requirements in relation to utilisation of genetic resources determined to be the causing pathogen of a ‘public health emergency of international concern’, such that a user may begin utilisation before the documentation is in place. However, after the short extension has passed, the user cannot claim patent rights nor continue with the utilisation until all the documentation is in place. This aspect of the legislation is of concern and highlights the importance of complying with the legislation.
What are the Penalties for breach?
The penalties for non-compliance are wide ranging and include powers of inspection and entry, discontinuation of the utilisation, monetary fines and criminal proceedings.
Researchers should make it policy to ensure documented compliance with the Nagoya Protocol. For instance, maintaining lists of research projects involving genetic resources, recording which projects fall within and outside the scope of the Nagoya Protocol, compiling evidence to prove compliance or reasons for projects falling out of scope. Defra is currently in the process of updating the UK guidance – this will provide welcome clarity on the interpretation of the legislation.