Access and Benefit Sharing laws and regulations govern access to the genetic resources, including how any benefits arising from their utilisation will be shared.
The Convention on Biological Diversity provides a global framework for action on biodiversity and helped to create 'Access and Benefit Sharing' (ABS) principles to reduce the inequalities between providers of the material and its users. Many countries now have national legislation that governs who can access their genetic resources and the traditional knowledge associated with these, and will negotiate with users how any benefits arising from their use will be shared.
Research integrity can in part be defined as abiding by the relevant guidance and policies, adopting the best practice and doing it continuously, throughout the research life cycle. Research integrity on one hand requires researchers to adhere to ABS laws and regulations but it also helps to inform ABS negotiations and discussions between partners. The Statement on Research Integrity sets out UCL's principles of integrity: honesty, rigour, transparency and open communication, care and respect, and personal responsibility. Applying these principles can help you fulfil the legal and moral obligation of ABS. Click on the tabs below to find out more:
- Abiding by the relevant guidance and policies
In order to fulfil this requirement, you need to know the relevant policies and laws. These will often differ between countries and/or institutions. In terms of ABS, each country can define who can access and export its genetic resources, and how. Some countries have signed up to the Nagoya Protocol, while others have developed their own national ABS legislation. Before exporting anything, be rigorous and make sure that you know what these laws and requirements are and adhere to them.
- Adopting the best practice
Even if there are no legal requirements, we need to apply the principles of integrity. We should show care and respect for the ‘providers’ of the resources, whether directly to the communities/researchers who provide the resources, or more generally to the countries where these materials originate from. We recommend that you always negotiate and agree appropriate benefit sharing via an honest, open and transparent communication with the ‘providers’.
- Continuous effort
Legislations and polices change and evolve over time. For ABS, more countries become parties to Nagoya Protocol and/or change and update their ABS requirements and processes. Each time you negotiate access you need to check if anything has changed. Additionally, the benefits may change over time as your project progresses, and therefore the ABS agreements may need to be re-negotiated over time.
Remember, it is researcher's personal responsibility to ensure that the ABS principles and laws are applied appropriately and complied with.
Examples of benefit-sharing
There is a wide variety of benefits, including obvious monetary benefits, like paying for access, but also many non-monetary benefits that could apply, like capacity and technology building; these could all have short-term and long-term consequences/benefits. Click on the tabs below to find out more:
- Fees for access to the samples
- Payment of royalties or licensing revenue generated from the commercialization of a product based on genetic resources
- Employing local researchers/communities as e.g. research assistants
- Setting up collaborations with researchers in the provider country
- Joint ownership of intellectual property rights, e.g. when seeking patents
- Co-authorship on publications
- Providing equipment/technology to the provider country
- Education and training of local researchers and others
- Technology transfer
Why is this important?
The disparity in research relationships unfortunately can stem from differences between high- and low-income countries. Researchers need to make sure that they show the same care and respect to everyone involved in research, regardless of where the research takes place. The ‘Global code of conduct’ helps to establish equitable international partnerships; it recognises the importance of ABS and this is included within the code.
Non-compliance with legal ABS requirements has clear consequences described in the legislation (e.g. financial penalties), but from a research integrity point of view, it is not only about adhering to the law, it is equally about doing the right thing. We generally undertake research to benefit society, whether with new knowledge or more practical outcomes. By applying the principle of care and respect we can make sure that these benefits are not only for those immediately connected to the research or the researchers, but for everyone. ABS requirements help to remind researchers of this and to ensure that benefits are shared equitably.
There are different types of ABS legislation, and it is important to check what legislation, if any, exists in the country in question and what the requirements are for complying with that legislation.
One main piece of ABS legislation is the Nagoya Protocol. While many countries are parties to the Nagoya Protocol, there are other countries that have developed their own legal ABS policies and regulations, and other countries that have no legal provisions for the sharing of genetic resources.
In addition to ABS legislation, it is importnant to note there are also other relevant international agreements that might apply, for example:
- The International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA)
- WHO's Pandemic Influenza Preparedness (PIP) Framework
The Nagoya Protocol
The Nagoya Protocol came into being in 2010, putting more detail to the ABS principles in a legally binding way. These regulations apply only to countries that have signed up to the Nagoya Protocol (Party to the Nagoya Protocol). The Nagoya Protocol was implemented into UK law through European Regulation (EU) No 511/2014 and the Statutory Instrument 'The Nagoya Protocol (Compliance) Regulations 2015'. Click on the tabs below to find out more:
Please see the definitions as used withing the Nagoya legislation:
Access means 'the acquisition of genetic resources or of traditional knowledge associated with genetic resources from a Party to the Nagoya Protocol'.
Genetic material means 'any material of plant, animal, microbial or other origin containing functional units of heredity'.
Genetic resources means 'genetic material of actual or potential value'.
Provider means local owners of the genetic resource or Party that has acquired the genetic resource in accordance with the Convention; often referred to as the provider country, which is the country of origin of the material.
User means 'a natural or legal person that utilises genetic resources or traditional knowledge associated with genetic resources'.
Utilisation of genetic resources means 'to conduct research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology as defined in Article 2 of the Convention'.
Traditional knowledge associated with genetic resources means 'traditional knowledge held by an indigenous or local community that is relevant for the utilisation of genetic resources and that is as such described in the mutually agreed terms applying to the utilisation of genetic resources'
Mutually Agreed Terms (MAT) is an agreement between the provider and user of genetic resources that governs the use of genetic resources and benefit-sharing conditions.
Prior Informed Consent (PIC) is approval by the authorities of the providing country of access to and utilization of genetic resources.
- What is protected under the Nagoya Protocol?
Genetic resources and the traditional knowledge associated with them are protected under the Nagoya Protocol.
It should be noted that while human genetic material is excluded from this definition, genetic resources derived from human microbiota could fall within the scope of ABS legislation. There is also an ongoing international discussion as to whether the DNA/RNA sequences - often called digital sequences information (DSI) - should also be part of ABS or not. Currently, while most countries do not have any provisions controlling these, there are some that do, so this needs to be checked on a case-by-case basis.
Please remember that ABS rules apply not only to the genetic material itself, but to the traditional knowledge associated with it as well. This is in recognition of the knowledge accumulated, often over long periods of time, by the providers, e.g. indigenous and local communities, traditional healers, ex-situ collection holders, land owners, etc., and the need to respect them and include them in the ABS conversations.
Find more information about the rules and requirements of this legislation, and how to get support, on the UCL Nagoya Protocol webpage.
How to comply?
When you are planning to import/export genetic resources:
- Check if any ABS legislation applies and adhere to it
- Even if there is not legislation in place, think how could you ensure equitable sharing of benefits
For more information and support relating to the Nagoya Protocol please contact the Compliance and Assurance Team in Research and Innovation Services: firstname.lastname@example.org
For further advice on equitable Access and Benefit Sharing contact the Research Integrity team: email@example.com