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About the Nagoya - Kuala Lumpur Supplementary Protocol on Liability and Redress

What is the Supplementary Protocol?

Adopted as a supplementary agreement to the Cartagena Protocol on Biosafety, the Supplementary Protocol aims to contribute to the conservation and sustainable use of biodiversity by providing international rules and procedures in the field of liability and redress relating to living modified organisms, as stated in its Article 1. The Protocol applies to damage resulting from living modified organism which find their origin in a transboundary movement (Article 3).

The Supplementary Protocol provides a definition of ‘damage’, referring to an adverse effect on the conservation and sustainable use of biological diversity that is measurable or otherwise observable and significant, taking also into account risks to human health. It provides for an indicative list of factors that should be used to determine the significance of an adverse effect. The Supplementary Protocol requires in Article 4 that a causal link between the damage and the living modified organism be established. States must require the appropriate operator or operators to take response measures in the event of damage resulting from living modified organisms which find their origin in a transboundary movement, as set out in Article 5. The ‘operator’ is defined as any person in direct or indirect control of the living modified organism. The operator must also take response measures where there is a sufficient likelihood that damage will result if timely response measures are not taken. Response measures may also be taken by the competent authority, for example when the operator has failed to do so. In such cases, the competent authority may recover the expenses and costs of such measures from the operator. In addition to the obligation to provide for response measures, Parties may develop civil liability rules and procedures to address damage. The Supplementary Protocol defines ‘response measures’ as reasonable actions to prevent, minimize, contain, mitigate or otherwise avoid damage, as appropriate, or reasonable actions to restore biological diversity. In addition to imposing a requirement for response measures, the Supplementary Protocol obliges Parties to continue to apply existing legislation on civil liability or to develop specific legislation concerning liability and redress for material or personal damage associated with damage to the conservation and sustainable use of biological diversity, as defined in the Supplementary Protocol. As response measures can be imposed by the competent administrative authority, rather than by a judicial body, the Supplementary Protocol is known as having introduced an ‘administrative approach’ to liability and redress.

  • Entry into force
  • Core obligations
  • Negotiation history

Entry into force

The Nagoya - Kuala Lumpur Supplementary Protocol on Liability and Redress was adopted on 15 October 2010 at the fifth meeting of the Conference of the Parties serving as the meeting of the Cartagena Protocol on Biosafety, held in Nagoya, Japan, and will enter into force on 5 March 2018.

The binding international agreement creates obligations for States that need to be implemented domestically.

More information on capacity building activities and materials available to support Parties in their efforts to implement the Supplementary Protocol are available here.

An overview of the status of the Supplementary Protocol is available here.

Core obligations

Core obligations from section IV of the introductory note: https://bch.cbd.int/protocol/NKL_ratification.shtml

The Supplementary Protocol on Liability and Redress supports Parties in their efforts to address damage to biological diversity resulting from living modified organisms by providing some essential elements for developing domestic legislative, administrative or judicial rules or procedures relevant to liability and redress. The Supplementary Protocol requires Parties to provide, in their domestic law, for rules and procedures that address damage. This requirement does not necessarily entail the enactment of a new law. It can be fulfilled by applying existing domestic law where this already addresses the elements required under the Supplementary Protocol.

The central obligation of Parties to the Supplementary Protocol is to provide for response measures in the event of damage resulting from living modified organisms, or where there is sufficient likelihood that damage will result if timely response measures are not taken. To that end, Parties to the Supplementary Protocol have to:

  1. Require that an operator, subject to any requirements of the competent authority, in the event of damage, must (i) immediately inform the competent authority; (ii) evaluate the damage; and (iii) take appropriate response measures.
  2. Require that an operator take appropriate response measures where there is sufficient likelihood that damage will result if timely response measures are not taken.
  3. Make sure that the competent authority (i) identifies the operator which has caused the damage; (ii) evaluates the damage; and (iii) determines which response measures should be taken by the operator.
  4. Require that decisions by the competent authority for the operator to take response measures are reasoned, that remedies are available, including administrative or judicial review of such decisions.
  5. Put in place a requirement whereby the competent authority itself may implement appropriate response measures, in particular in situations where the operator has failed to do so.
  6. Provide the competent authority the right to recover, from the operator, costs and expenses incurred in relation to the implementation of the response measures.

To assist in interpreting and implementing these obligations, the Supplementary Protocol includes definitions of some key terms, in particular:
  • “damage”, which is defined as an adverse effect on the conservation and sustainable use of biological diversity, taking also into account risks to human health, that is measurable or otherwise observable and significant. Criteria to determine whether the effect is significant are provided in the Supplementary Protocol.
  • “operator”, which is defined in the Supplementary Protocol as any person in direct or indirect control of the living modified organism. The determination of who the specific operator might be in any given circumstance is left to domestic law.
  • “response measures”, which are defined as reasonable actions to (i) prevent, minimize, contain, mitigate, or otherwise avoid damage, as appropriate; and (ii) restore biological diversity. The operator or the competent authority, as the case may be, is also expected to undertake actions following a specified order of preference as part of the response measures for the restoration of biological diversity.

Parties are furthermore required to continue to apply their existing general law on civil liability or to apply or develop and apply civil liability rules and procedures specifically for the purpose of providing adequate rules on civil liability for material or personal damage associated with the damage, as this is defined in the Supplementary Protocol.

Negotiation history of the Supplementary Protocol

Liability and redress for damage resulting from the transboundary movements of living modified organisms was one of the most controversial issues during the negotiations of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity. Some were in favour of rules on liability and redress being developed and included in the Protocol while others were opposed to the idea of having any such provision in the Protocol. Some argued that even if there was consensus to have substantive rules on liability and redress in the Protocol, there was not enough time to elaborate such rules, which were believed to be highly complex and sensitive to several Governments. As the negotiations on the Protocol entered the final phase, negotiators realized that there was a lack of both consensus and sufficient time to deal with any contents of possible rules on liability and redress. It was, therefore, finally accepted to continue the debate in a more deliberate manner after the adoption and entry into force of the Protocol.

Accordingly, the Biosafety Protocol was adopted in January 2000. It contains a provision committing the Conference of the Parties serving as the meeting of the Parties to the Protocol (COP-MOP, the governing body of the Protocol) to adopt, at its first meeting, a process for the elaboration of liability and redress rules. That commitment was reflected in Article 27 of the Protocol which states as follows: “The Conference of the Parties serving as the meeting of the Parties to this Protocol shall, at its first meeting, adopt a process with respect to the appropriate elaboration of international rules and procedures in the field of liability and redress for damage resulting from transboundary movements of living modified organisms, analysing and taking due account of ongoing processes in international law on these matters, and shall endeavour to complete this process within four years.”

The Intergovernmental Committee on the Cartagena Protocol on Biosafety, an interim arrangement established following the adoption of the Protocol to oversee preparations for the entry into force of the Protocol, carried out extensive work on a number of items, including liability and redress in the context of Article 27 of the Protocol. The Biosafety Protocol entered into force on 11 September 2003. Soon after, in February 2004, the first meeting of the COP-MOP was held. The meeting decided to establish, on the basis of the work and recommendations of the Intergovernmental Committee, an Open-ended Ad Hoc Working Group of Legal and Technical Experts on Liability and Redress to carry out the process pursuant to Article 27 of the Protocol.

The Working Group met five times between 2005 and 2008. The result of the five meetings of the Working Group supplemented by the work of a small group that met just before COP-MOP 4 was submitted to the fourth meeting of the Parties. Negotiations also continued in a contact group setting during COP-MOP 4. All these deliberations advanced the negotiations well. Nevertheless, they were not sufficient to resolve all the outstanding issues and to lead the process to finalization in 2008. Consequently, COP-MOP 4 adopted a decision 3 in which Parties agreed to establish a Group of the Friends of the Co-Chairs of the former Working Group to continue the negotiations.

The Group of Friends of the Co-Chairs met four times between 2008 and 2010. It finally agreed to the text of the Nagoya – Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety and submitted its report, including the text and a draft decision on 11 October 2010 for the consideration and adoption of the fifth meeting of the COP-MOP in Nagoya, Japan. The Supplementary Protocol was adopted on 15 October 2010. The decision that adopted the Supplementary Protocol, i.e. decision BS-V/11, calls upon Parties to the Biosafety Protocol to sign the Supplementary Protocol at their earliest opportunity from 7 March 2011 to 6 March 2012. Parties to the Biosafety Protocol are also called upon to deposit their instruments of ratification, acceptance or approval or instruments of accession, as appropriate, as soon as possible.

A more detailed description of the negotiating history of the Supplementary Protocol is available here.

Timeline of the Nagoya - Kuala Lumpur Supplementary Protocol

         
1994 COP 1 First Meeting of the Conference of the Parties- Establishment of the Intergovernmental Committee for the Cartagena Protocol on Biosafety (ICCP) Nassau, Bahamas, 28 November- 9 December 1994   Decision EM-I/3
2001 ICCP2 Second meeting of the Intergovernmental Committee for the Cartagena Protocol on Biosafety (ICCP) Nairobi, Kenya, 1 - 5 October 2001   Recommendation 2/1
2002 ICCP3 Third meeting of the Intergovernmental Committee for the Cartagena Protocol on Biosafety (ICCP) - Consideration of a compilation of views on the term of reference of an expert group for COP-MOP 1. The Hague, Netherlands, 22-26 April 2002   Recommendation 3/1
2004 COP-MOP1 First meeting of the COP-MOP- Establishment of an Open-Ended Ad Hoc Working Group of legal and technical experts on liability and redress in the context of the Protocol. Kuala Lumpur, Malaysia, 23 -27 February 2004   Decision BS-I/8
2004 Technical Group of Experts Technical Group of Experts on Liability and Redress- Preparation of the Ad Hoc Working Group 1. Montreal, Canada, 18 - 20 October 2004   Meeting page
2005 Ad Hoc Working Group 1 First Meeting of the Ad Hoc Working Group of legal and technical experts on liability and redress. Montreal, Canada , 25 - 27 May 2005   Meeting page
2005 COP-MOP 2 Second Meeting of the COP-MOP- considered report of the Ad Hoc Working Group 1 and agreed to second meeting of the group. Montreal, Canada, 30 may- 3 June 2005   Decision BS-II/11
2006 Ad Hoc Working Group 2 Second Meeting of the Ad Hoc Working Group of legal and technical experts on liability and redress - Development of an indicative list of criteria for the assessment of the effectiveness of any rules and procedures referred to in Article 27 of the Protocol. Development of different options for operational text on scope, damage and causation. Montreal, Canada, 20-24 February 2006   Meeting page
2006 COP-MOP 3 Third Meeting of the COP MOP- welcomed the progress made by the Working Group and agreed that three five-day meetings of the Working Group should be convened before the next COP-MOP. Curitiba, Brazil, 13-17 March 2006   Decision BS-III/12
2007 Ad Hoc Working Group 3 Third Meeting of the Ad Hoc Working Group of legal and technical experts on liability and redress - Consideration of a blueprint for a COP-MOP decision on international rules and procedures in the field of liability and redress. Montreal, Canada, 19-23 February 2007   Meeting page
2007 Ad Hoc Working Group 4 Fourth Meeting of the Ad Hoc Working Group of legal and technical experts on liability and redress - Revision of the blueprint. Montreal, Canada, 22-26 October 2007. Montreal, Canada, 22-26 October 2007   Meeting page
2008 Ad Hoc Working Group 5 Fifth Meeting of the Ad Hoc Working Group of legal and technical experts on liability and redress - Revision of the working draft on the elaboration of options for rules and procedures in the context of Article 27 of the Protocol. Cartagena, Colombia, 12-19 March 2008   Meeting page
2008 Meeting of the Friends of the Co-Chairs Meeting of the Friends of the Co-Chairs Prior to COP-MOP 4- Negotiation of the Final Report of the WG. Bonn, Germany, 7 - 10 May 2008   Proposed operational text
2008 COP-MOP 4 Fourth Meeting of the COP-MOP- Considered the final report of the WG- Adopted the text from the meeting of the Friends of the Co-Chairs as the basis for work - Established a contact group to continue the negotiations- Adoption of the negotiating text as revised by the contact group as the basis for further work- Agreed to establish a Group of the Friends of the Co-Chairs to continue the process.. Bonn, Germany, 12 - 16 May 2008   Decision BS-IV/12
2008 Meeting of the Friends of the Co-Chairs (1) First Meeting of the Friends of the Co-Chairs- Production of a draft text for a supplementary protocol on liability and redress to the Biosafety Protocol (towards a legally binding instrument). Mexico City, Mexico, 23- 27 February 2009   Meeting page
2010 Meeting of the Friends of the Co-Chairs (2) Second Meeting of the Friends of the Co-Chairs- Negotiation of the draft supplementary protocol. Kuala Lumpur, Malaysia, 8- 12 February 2010   Meeting page
2010 Meeting of the Friends of the Co-Chairs (3) Third Meeting of the Friends of the Co-Chairs - Negotiation of the draft supplementary protocol and draft guidelines on civil liability. Kuala Lumpur, Malaysia, 15-19 June 2010   Meeting page
2010 Meeting of the Friends of the Co-Chairs (4) Fourth Meeting of the Friends of the Co-Chairs - Submission to COP-MOP 5 of the Nagoya – Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety, together with a draft decision for consideration and adoption. Nagoya, Japan, 6-11 October 2010   Meeting page
2010 COP-MOP 5 Fifth Meeting of the COP-MOP- Adoption of the Nagoya – Kuala Lumpur Supplementary Protocol on Liability and Redress- Additional and supplementary compensation measures may be taken in instances where the costs of response measures provided for in the Supplementary Protocol are not covered and that those measures may include arrangements to be addressed by the COP-MOP. Nagoya, Japan, 11-15 October 2010   Decision BS-V/11

Other relevant biosafety documents are available in the sections Meetings of the COP-MOP and Publications