The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization entered into force on October 12, 2014. While the United States has not yet ratified it, the protocol will likely have an impact on companies commercializing products, such as pharmaceuticals, derived from genetic resources, including plants, animals and bacteria, to the extent that the protocol addresses access to them, contractual obligations, the use of relevant traditional knowledge, biodiversity, and sustainable development. The protocol requires that informed consent be obtained for access to genetic resources and that benefits from their use be shared “in a fair and equitable way” with the party providing the resources.
A number of jurisdictions have developed measures to implement the protocol; for example, the European Union has adopted a regulation that imposes an obligation of due diligence on those using genetic resources. Some, such as India, will impose prison terms, fines, fees, and royalties on those who fail to gain approval from the appropriate regulatory authority to use or transfer genetic resources. Environmentalists and scientists contend that the protocol will limit “biopiracy,” defined as the misappropriation of traditional or indigenous knowledge through international patents that primarily benefit multinational corporations. The earnings that these companies will now have to share are expected to help lowincome countries finance their conservation initiatives. See U.N. Press Release, October 8, 2014; Inter Press Service, October 22, 2014.