FIND position statement: the Nagoya Protocol

The Nagoya Protocol was designed to provide a legal framework to ensure that the benefits arising from the utilization of genetic resources are shared in a fair and equitable way with donor countries or organizations; this includes biological samples that are essential to the development of diagnostics. This statement summarizes FIND’s position on this.

Although the protocol was agreed in 2010 and entered into force in 2014, many countries still do not have an operational infrastructure to support benefit sharing, and those that have, in many instances, have addressed their obligations in different ways. A total of 60 countries are not party to the protocol, including the United States, Russia, Australia, Canada, and New Zealand. This has led to general uncertainty and a brake on research, while unreasonable expectations on the part of certain providers has led to the phenomenon of ‘Nagoya avoidance’, whereby researchers avoid working with such provider countries or institutions.

Access to digital sequence information (DSI) has become vital to research and development in recent years. But despite many years of discussion, the protocol does not specify whether DSI is covered by the definition of genetic material.

To ensure that countries receive the benefits from sharing of their genetic resources, including DSI, we are calling for:

  • Completion of the integration of the Nagoya Protocol obligations into national laws
  • Consensus on interpretation of the Nagoya Protocol within provider countries, including agreement on definitions of key terms
  • DSI providers to opt explicitly either to allow free public access to their data, or to retain their rights concerning that data, in alignment with World Health Organization principles for pathogen genome sharing. If rights are retained, to negotiate benefit sharing terms with users
  • Overarching efforts to increase transparency and build confidence and trust in the Nagoya Protocol through international collaboration and co-operation

Policy brief on diagnostics & the Nagoya Protocol

The Nagoya Protocol is an international agreement, supplementary to the United Nations Convention on Biological Diversity. It provides a legal framework designed to ensure that the benefits arising from the utilization of genetic resources and associated traditional knowledge are shared in a fair and equitable way with the contributor.