Nagoya Protocol on Access and Benefit-sharing

Nagoya Protocol on Access and Benefit-sharing
Name	Nagoya Protocol on Access and Benefit-sharing
Date signed	29 October 2010
Location signed	Nagoya
Condition effective	Entry into force
Date effective	12 October 2014
Parties	140+
Depositor	United Nations

Nagoya Protocol on Access and Benefit-sharing is an international agreement supplementing the Convention on Biological Diversity that establishes rules for access to genetic resources and the equitable sharing of benefits arising from their utilization. Negotiated through meetings of the Conference of the Parties to the Convention on Biological Diversity and adopted at the Tenth meeting of the Conference of the Parties to the Convention on Biological Diversity, it was opened for signature in Nagoya and entered into force following ratifications including by Japan and the European Union. The Protocol interfaces with instruments such as the Cartagena Protocol on Biosafety, the International Treaty on Plant Genetic Resources for Food and Agriculture, and national legislation like Brazilian Biodiversity Law and India's Biological Diversity Act.

Background and objectives

The Protocol originated from discussions at the Rio Summit and subsequent sessions of the Conference of the Parties to the Convention on Biological Diversity, responding to concerns raised by Indigenous and Tribal Peoples of the Amazon, Brazil, South Africa, and India about biopiracy and misappropriation of biological resources. Its primary objectives mirror Article 1 of the Protocol text negotiated in Montreal and Hyderabad, aiming to implement Article 15 of the Convention on Biological Diversity by promoting fair and equitable benefit-sharing between provider states and user entities such as pharmaceutical companies, research institutions, and biotechnology firms including Novartis, Merck & Co., and Bayer. The Protocol also seeks to support traditional knowledge associated with genetic resources held by Indigenous peoples, local communities, and custodians in regions like the Congo Basin, the Andes, and the Coral Triangle.

Key provisions

The Protocol sets out requirements for Prior Informed Consent (PIC) and Mutually Agreed Terms (MAT) between providers and users, mechanisms that affect stakeholders from World Intellectual Property Organization observers to national patent offices such as the European Patent Office and the United States Patent and Trademark Office. It establishes an Access and Benefit-Sharing Clearing-House (ABSCH) administered by the Secretariat of the Convention on Biological Diversity and interfaces with International Union for Conservation of Nature processes and UNESCO heritage frameworks. The Protocol includes provisions for compliance measures, checkpoints engaging customs authorities like World Customs Organization, and measures affecting actors such as Rosatom-linked research consortia, Smithsonian Institution collections, and university networks including University of Cambridge and Harvard University.

Implementation and compliance

Implementation involves national frameworks exemplified by European Union Regulation (EU) 511/2014, China's Biodiversity Law reforms, and Brazil's Provisional Measure 2.186-16. Compliance relies on national focal points, competent national authorities, and checkpoints such as border agencies including INTERPOL collaborations and customs cooperation with the World Trade Organization norms. Capacity-building initiatives have been supported by partners like the Global Environment Facility, World Bank, UNDP, and the International Union for Conservation of Nature to assist countries including Kenya, Peru, Indonesia, and Madagascar in drafting access legislation and building administrative systems.

Parties and governance

Parties to the Protocol include states and regional economic integration organizations such as the European Union and states ranging from Germany and Mexico to Fiji and Rwanda. Governance occurs through the Conference of the Parties serving as the meeting of the Parties to the Nagoya Protocol (COP-MOP), supported by subsidiary bodies and the Secretariat hosted by the Secretariat of the Convention on Biological Diversity in Montreal. Observers include non-governmental organizations such as WWF, Greenpeace, Bioversity International, and industry coalitions like the Biodiversity and Business Network, while advisory inputs have come from bodies such as the Intergovernmental Science-Policy Platform on Biodiversity and Ecosystem Services.

Impact and controversies

The Protocol has influenced research collaborations involving institutions like Novartis Institutes for BioMedical Research, Sanofi, and university consortia including University of Tokyo partnerships, and affected access to collections at museums such as the Natural History Museum, London and the Smithsonian Institution. Controversies include debates over scope—whether it applies to digital sequence information debated at COP15—and its interaction with intellectual property systems such as patent offices including the European Patent Office and litigation environments in jurisdictions like the United States and Brazil. Critics including representatives from the World Federation of Biotechnology and some research universities argue compliance can increase transaction costs and impede pandemic response research exemplified by issues raised during the Ebola virus epidemic and the COVID-19 pandemic, while proponents cite benefit-sharing agreements with companies such as Shaman Pharmaceuticals and community agreements in Vanuatu as positive outcomes.

Case studies and applications

Notable applications include benefit-sharing arrangements from bioprospecting in the Seychelles and Costa Rica leading to revenue-sharing with local communities and national funds managed by institutions like National Biodiversity Institute (Costa Rica). The Andes-Amazon Initiative and agreements involving Traditional knowledge custodians in Peru illustrate community-level protocols, while cases in India under the Biological Diversity Act demonstrate national permitting systems interfacing with academic research at institutions such as the Indian Council of Medical Research and Council of Scientific and Industrial Research. Pharmaceutical collaborations with nations like Brazil and South Africa have produced licensing and benefit-sharing contracts processed through national competent authorities and showcased at forums including sessions of the Conference of the Parties to the Convention on Biological Diversity.

Category:International environmental law Category:Convention on Biological Diversity protocols