Background
The Convention on Biological Diversity and the Nagoya Protocol
The Convention on Biological Diversity (CBD) is an international treaty that recognizes the sovereign rights of states over their natural resources and consequently gives to the State the right to determine access to genetic resources within its national jurisdiction (including marine genetic resources). It was adopted in 1992 and entered into force in 1993. This international legal framework has implications for users of genetic resources (GR). When implemented at the national level, through the adoption of an ABS national legislation requiring prior informed consent (PIC) to access GR and the negotiation of mutually agreed terms (MAT) usually regulating utilization of GR, the share of the benefits arising from their utilization and the transfer to third parties, users have to comply with the requirements of the national ABS legislation and have to obtain these permits before assessing the resources in situ. Scientists that want to sample and utilize GR therefore have to follow certain steps in order to ensure ABS compliance: these steps are illustrated in the section on Guidelines.
The Nagoya Protocol of the CBD provides a legal framework for further implementing the third objective of the CBD, i.e. access to genetic resources and the sharing of benefits arising from the use of genetic resources. The Protocol was adopted in 2010 and entered into force in October 2014. All Parties to the Protocol are obliged to monitor the use of genetic resources within their jurisdiction. More precisely, the Nagoya Protocol puts obligations both on the user and the provider: while the user of GRs must abide by the law of the providing country, the latter must ensure certainty and clarity of the requirements and measures for granting access to GRs.
Figure 1. ABS Framework
Source: Factsheet on Access and Benefit-Sharing, Secretariat of the Convention on Biological Diversity, 2011
European Union Regulation on Compliance and the Implementing Regulation
The compliance provision of the Nagoya Protocol requires that State parties take “appropriate, effective and proportionate measures” in order to ensure the compliance of their users with the ABS rules in the providing country they are working with. In implementing this provision, the European Union (EU) therefore put an obligation of due diligence on the users. The European Parliament and the Council adopted the new Regulation ((EU) No 511/2014) on 16 April 2014. Implementing the mandatory elements of the Nagoya Protocol in the European Union, it entered into force on 9 June 2014 and applies from the date the Nagoya Protocol itself entered into force for the Union, i.e. 12 October 2014. Its provisions range from the direct obligations of the user to apply and declare due diligence to the obligations of EU Member States with regards to monitoring and checking user compliance, and include a Register of collections for ex situ access to GRs.
The EU Implementing Regulation contains measures on some specific aspects, as provided for in the EU ABS Regulation, in particular registered collections, best practices and monitoring of user compliance. It was adopted by the Commission on 13 October 2015, with entry into force on 9 November 2015.
The United Nations Convention on the Law of the Sea
Because the sovereignty of a State can extend to the sea, the CBD and the Nagoya Protocol also apply in the maritime jurisdiction of a coastal State that has adopted ABS measures. However, at sea, this ABS framework overlaps with the one of the United Nations Convention on the Law of the Sea, adopted in 1982 and entered into force in 1994. The United Nations Convention on the Law of the Sea (UNCLOS) sets out the global legal framework within which all activities in the oceans and seas must be carried out, including marine scientific research (MSR). In particular, UNCLOS defines the limits of the various maritime zones as well as the respective rights and obligations of coastal States and flag States within those zones. In its simplest terms, the UNCLOS is a global and general framework setting the boundaries of States’ jurisdiction and regulating the activities taking place there, including MSR. Although it does not refer explicitly to genetic resources, it does address ‘living’, ‘natural’ or ‘biological’ resources in terms of conservation, exploitation and research. Therefore a State that regulates MSR in its waters may impose certain access restrictions to the MGR within its jurisdiction.