Why the Protocol Exists
The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union (the Protocol) is an international agreement (of which the UK is a member state) which enforces the sharing of benefits derived from the utilisation of genetic resources obtained in any other member-state since 12 October 2014.
The Protocol was implemented to encourage ethical bioprospecting (trying to “hit gold” with a biological product) and prevent “biopiracy”: scenarios where third parties make use of a nation’s genetic resources without contributing to that nation. A principle of the Protocol is that a nation should benefit from its genetic wealth similar to how a country may benefit from its mineral wealth e.g. levies raised through mining rights to veins of gold.
The Protocol is designed to prevent situations where a nation’s genetic resources contain a blockbuster compound or process and this is identified by a company who exploit that information, make considerable capital and do not contribute to the country which provided the environment for the genetic resource to develop. This is particularly the case where traditional knowledge was involved in the identification of the compound, e.g. in the example of the Nagoya Pound where 2000 years ago it was identified that sweet wormwood tea could be used as an antimalarial (this was developed into artemisinin).
The following is a historic case which occurred prior to the implementation of the Nagoya Protocol, but demonstrates what the Protocol is set to prevent:
Indigenous Brazilian tribes had historically identified that coating their arrowheads in the venom of the Brazilian pit viper considerably increased their efficacy. Because the tribes used the venom, scientists explored how it functioned: the venom caused the snake’s prey to lose consciousness due to a sudden loss of blood pressure. It was therefore felt that this feature of the venom could be used to treat high blood pressure.
Through considerable research, the active ingredient in the venom (Teprotide, a 9-amino acid chain) and its active motif (a terminal proline) was identified. A mimic of the active motif was then developed into a working drug: Captopril, the first Angiotensin-Converting Enzyme (ACE) inhibitor. Captopril and its derivatives (e.g. Enalapril, Lisinopril and Ramipril) have been sold worldwide and made billions of dollars for the companies which developed them.
Despite the considerable research, development and innovation required to bring these drugs to market, each of these drugs fundamentally rely on the identification of the utility of the venom by the indigenous Brazilian tribes (otherwise Teprotide may never have been discovered), as well as the genetics of the Brazilian pit viper (which is a product of Brazil’s ecosystem).
It is now felt that it would be just for countries (e.g. Brazil) to co-profit from the utilization of their genetic resources, especially where traditional knowledge is involved.
Applicable Genetic Resources and Users’ Obligations
The UK regulations apply to any company, organisation or individual conducting research and development on genetic resources and / or traditional knowledge (the user) where:
- The genetic material and / or traditional knowledge was accessed on or after 12 October 2014,
- was from a country that is a party to the Nagoya Protocol, and
- the country has access and benefit sharing (ABS) legislation
- “Genetic resources” include any naturally occurring genetic matter (e.g. plants, animals, microbial life).
- Utilization includes research and development on the genetic or biochemical composition of genetic resources, as well as subsequent applications and commercialization.
- Traditional knowledge is not required for the Protocol to apply to a genetic resource.
The user is responsible for undertaking due diligence to ensure they are compliant with the relevant legislation (see below), and must submit a due diligence declaration as required.
In countries with ABS legislation, users must ensure that applicable genetic material was obtained with prior informed consent and on mutually agreed terms, providing domestic-level benefits to the other party. Benefits may be monetary or non-monetary such as royalties or the sharing of research results.
As this is relatively new legislation, scientific communities, including the private sector, individual institutions and organizations, have begun to design policy and best practices for compliance.
Microbiologists and culture collections alike need to be aware of the legislation of the source country of the materials they use and put in place best practices for compliance; such best practice has been drafted by the Microbial Resource Research Infrastructure, and other research communities such as the Consortium of European Taxonomic Facilities, the Global Genome Biodiversity Network and the International Organisation for Biological Control have published best practice and/or codes of conduct to ensure legitimate exchange and use of genetic resources.
The relevant regulations which enforce compliance measures in the UK are:
- The Nagoya Protocol (Compliance) Regulations 2015 (UK Statutory Instrument, No. 821)
- Regulation (EU) No. 511/2014 on compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation in the Union
- Implementing Regulation (EU) 2015/1866 laying down the detailed rules for the implementation of Regulation (EU) 511/2014 as regards the register of collections, monitoring user compliance and best practices
This legislation is implemented and enforced in the UK by the Office for Product Safety and Standards (Safety & Standards).
The UK currently does not have access controls in place at this time, therefore its genetic resources may be freely exploited. The UK will however cooperate in cases concerning the alleged violation of other member states ABS legislation.
Member States’ Access and Benefit Sharing Legislation and Protocols
Member states implementing Nagoya Protocol ABS legislation must provide clear and non-arbitrary legislation, towards:
- Access to the genetic resources
- What constitutes “prior informed consent” and “mutually agreed terms”
- Provide for the issuance of a permit or equivalent when access is granted
- Encourage contractual provisions on dispute resolution in mutually agreed terms
- Ensure an opportunity is available to seek recourse under their legal systems when disputes arise from mutually agreed terms
- Take measures regarding access to justice
- Take measures to monitor the utilization of genetic resources after they leave a country including by designating effective checkpoints at any stage of the value-chain: research, development, innovation, pre-commercialization or commercialization
All member states (including those who are not implementing ABS legislation) must cooperate in cases of alleged violation of another contracting party’s requirements.
Some countries have not implemented Nagoya Protocol ABS legislation at this time, or already have laws providing ABS measures under the Convention on Biological Diversity 1992.
Because of this variability in access and benefit sharing legislation, information on how this has been implemented in each country is available at the ABS Clearing House.