Culture collections and Access and Benefit Sharing (Nagoya Protocol)
The Convention on Biological Diversity (CBD) entered into force on 29 December 1993. Its aims are to conserve biological diversity, foster its sustainable use, and the fair and equitable sharing of benefits arising from the utilization of ‘genetic resources’ and/or traditional knowledge associated with such resources. According to the CBD, genetic resources are defined as ’genetic material of actual or potential value’ and genetic material is defined as ‘any material of plant, animal, microbial or other origin containing functional units of heredity’. So, the biological materials typically preserved in culture collections fall within scope of the CBD. However human cell lines, as all human genetic resources, are out of scope of the CBD. The CBD recognizes the sovereign rights of countries over their own ‘genetic resources’, and countries are expected to grant access to their genetic resources (and associated traditional knowledge) and can determine the conditions for access.
The Nagoya Protocol entered into force on 12 October 2014. Parties to the Protocol may regulate access to their genetic resources and require ‘Prior Informed Consent’ (PIC) from the competent national authority and the settling of ‘Mutually Agreed Terms’ (MAT) between provider and user of the genetic resources. Countries can also decide to provide “free” access to their genetic resources, so without any ABS requirements. Yet, all Parties are obliged to take measures to monitor the use of foreign resources within their territory, and assure that users comply with ABS legislation of the provider countries of those genetic resources.
The European Union adopted the Regulation (EU) No 511/2014 (EU ABS Regulation), which also entered into force on 12 October 2014. This regulation governs user compliance measures and benefit sharing within the EU, but it does not deal with access to the genetic resources as this is left to the individual Member States. The EU ABS Regulation is complemented by the Commission Implementing Regulation (EU) 2015/1866 (EU 2015) providing detailed rules as regards the register of collections, monitoring user compliance and best practices.
As supporters of the goals of the CBD and long-time contributors to ex-situ conservation of (microbial) biodiversity, culture collections have been actively involved in various fora and stakeholder meetings organized by the ABS policy makers at national, European and global level. Whenever possible, they have clarified practical implications and the potential negative impact of ABS regimes on collection management, microbiology and open science in general, and bioeconomic development. Initiatives were taken to develop Codes of Conduct, Best Practices, Model Agreement documents and other tools to support culture collection staff and the users of resources in public collections to comply. Below several useful links are provided.
Information resources on ABS
The Access and Benefit Sharing Clearing House (ABSCH) – ABSCH | Access and Benefit-Sharing Clearing-House (cbd.int)
The EU pages on Access and Benefit Sharing – Environment – European Commission – Biodiversity – International – Genetic resources and ABS (europa.eu)
The German Nagoya Protocol Hub – Especially interesting are the cases presented of successful applications for PIC and MAT in countries worldwide. https://www.nagoyaprotocol-hub.de/https://www.nagoyaprotocol-hub.de/