Cartagena Protocol on Biosafety .1 Introduction

The Cartagena Protocol on Biosafety to the Convention on Biological Diversity was signed in 2000 and entered into force in 2003. It ‘creates an enabling environment for the environmentally sound application of biotechnology, making it possible to derive maximum benefit from the potential that biotechnology has to offer, while minimizing the possible risks to the environment and to human health’.⁸⁴ The objec-tive of the Protocol is to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustain-able use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements.⁸⁵ Under the Protocol, Parties

81 Decision X/2 (2010).

82 Ibid. III and IV.

83 Ibid. at IV, V and VI.

84 Cartagena Protocol on Biosafety to the Convention on Biological Diversity: text and annexes (Sec-retariat of the Convention on Biological Diversity, 2000), 1.

85 Art. 1.

49 Marko Berglund and Wanhua Yang shall ensure that the development, handling, transport, use, transfer and release of any living modified organisms are undertaken in a manner that prevents or reduces the risks to biological diversity.⁸⁶

The Protocol establishes a notification and decision-making procedure with regard to the transboundary movement of living modified organisms⁸⁷ and contains provi-sions with regard to risk assessment and management⁸⁸ as well as unintentional movements⁸⁹ and handling transport packaging and identification.⁹⁰ The Protocol also sets up a biosafety ‘clearing house’⁹¹ and has provisions, inter alia, on capacity-building⁹² and public awareness and participation.⁹³

3.4.2 Performance review information

Under the Protocol, each Party shall monitor the implementation of its obligations and shall report to the Conference of the Parties serving as the Meeting of the Parties on measures that it has taken to implement the Protocol.⁹⁴ In 2004 the COP/MOP decided on a four-year reporting cycle, with interim reports due two years after the entry into force of the Protocol.⁹⁵ In 2006, the COP/MOP adopted the reporting format, which includes a section on obligations for the provision of information to the Biosafety Clearing-House, as well as on all other major provisions of the Proto-col.⁹⁶ The reporting format for the second national reports was adopted in 2010.⁹⁷ 3.4.3 Non-compliance procedure

The Protocol called for the Conference of the Parties, at its first meeting, to con-sider and approve cooperative procedures and institutional mechanisms to promote compliance with the provisions of the Protocol and to address cases of non-compli-ance. The Protocol further stipulated that these procedures and mechanisms shall include provisions to offer advice or assistance, where appropriate.⁹⁸ The procedures and mechanisms on compliance were adopted in 2004 and a Compliance Commit-tee was established.⁹⁹ The procedures and mechanisms contain sections on the objec-tive, nature and underlying principles; institutional mechanisms; functions of the

86 Art. 2.2.

87 Arts 7 to 13.

88 Arts 15 and 16.

89 Art. 17.

90 Art. 18.

91 Art. 20.

92 Art. 22.

93 Art. 23.

94 Art 33.

95 ‘Monitoring and reporting under the Protocol (Article 33): format and timing for reporting’, Decision BS-I/9 (2004).

96 ‘Monitoring and reporting’, Decision BS-III/14 (2006), Annex: ‘Format for the First Regular National Report on the Implementation of the Cartagena Protocol on Biosafety’.

97 ‘Monitoring and reporting (Article 33)’, Decision BS-V/14 (2010).

98 Art. 34.

99 ‘Establishment of procedures and mechanisms on compliance under the Cartagena Protocol on Biosafety’, Decision BS-I/7 (2004).

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Committee; procedures; information and consultation; measures to promote compli-ance and address cases of non-complicompli-ance; and review of the procedures and mech-anisms.

The compliance procedures and mechanisms were envisaged to be simple, facilitative, non-adversarial and cooperative in nature, and their operation is guided by the prin-ciples of transparency, fairness, expedition and predictability. The mechanism pays particular attention to the special needs of developing country Parties, in particular the least developed and small island developing states among them, and Parties with economies in transition, acknowledging the difficulties they face in the implementa-tion of the Protocol.¹⁰⁰

The Compliance Committee meets twice a year and it consists of 15 members, three from each UN region, with recognized competence in the field of biosafety or other relevant fields, including legal or technical expertise, serving objectively and in a personal capacity.¹⁰¹ The Committee identifies the specific circumstances and possible causes of individual cases of non-compliance referred to it; considers information submitted to it regarding matters relating to compliance and cases of non-compli-ance; provides advice and/or assistance, as appropriate, to the concerned Party, on matters relating to compliance with a view to assisting it to comply with its obliga-tions under the Protocol; reviews general issues of compliance by Parties with their obligations under the Protocol, taking into account the information provided in the national reports communicated in accordance with Article 33 of the Protocol and also through the Biosafety Clearing-House; takes measures, as appropriate, or makes recommendations, to the COP/MOP of the Protocol; and carries out any other functions as may be assigned to it by the COP/MOP.¹⁰² The Committee is to receive, through the Secretariat, any submissions relating to compliance from any Party with respect to itself; and from any Party, where this Party is affected or likely to be af-fected, with respect to another Party. The Committee may reject considering such latter submissions where these are, ‘bearing in mind the objectives of the Protocol’, either de minimis or ill-founded.¹⁰³

3.4.4 Non-compliance response measures

The Committee may take one or more measures with a view to promoting compli-ance and addressing cases of non-complicompli-ance, taking into account the capacity to comply of the Party concerned, especially developing country Parties, in particular the least developed and small island developing states amongst them, and Parties with economies in transition.. In addition, such factors as the cause, degree, frequency and type of non-compliance have to be taken into account in the considerations.

100 Decision BS-I/7, Annex ‘Procedures and Mechanisms on Compliance under the Cartagena Protocol on Biosafety’, Section I.

101 Ibid. Section II.

102 Ibid. Section III.

103 Ibid. Section IV.

51 Marko Berglund and Wanhua Yang The Committee may provide advice or assistance to the Party concerned, as appropri-ate; make recommendations to the COP/MOP regarding the provision of financial and technical assistance, technology transfer, training and other capacity-building measures; request or assist, as appropriate, the Party concerned to develop a compli-ance action plan regarding the achievement of complicompli-ance with the Protocol within a timeframe to be agreed upon between the Committee and the Party concerned;

invite the Party concerned to submit progress reports to the Committee on the efforts it is making to comply with its obligations under the Protocol; and report to the COP/MOP on efforts made by Parties in non-compliance to return to compliance and maintain this as an agenda item of the Committee until adequately resolved.¹⁰⁴ The COP/MOP may take further measures relating to a Party’s non-compliance. On the facilitative range of the spectrum the COP/MOP may provide financial and technical assistance, technology transfer and training and other capacity-building measures. Information can be shared among Parties through publishing cases of non-compliance in the Biosafety Clearing-House.¹⁰⁵ On the more punitive side the COP/

MOP may issue a caution to the concerned Party. To build Parties’ confidence in the process, however, the COP/MOP decided that if a Party itself triggers a case of non-compliance only facilitative and supportive measures should be recommended by the Committee and adopted by the COP/MOP.

The Compliance Committee has met nine times since it was established. The first meetings focused mostly on procedural matters, such as agreeing on rules of proce-dure, including conflicts of interest, and identifying the role of the Committee vis-à-vis other processes under the Convention. The Committee also reviewed lessons learned from other MEAs regarding repeated cases of non-compliance.

Reporting is a time-consuming and challenging issue for many parties: the Commit-tee raised the importance of the matter in 2007 after only 50 parties had submitted their first national reports on time.¹⁰⁶ Much progress had been made by 2012, though, when the Committee noted that only 17 Parties had not submitted their second national reports.¹⁰⁷ The Committee has also addressed the need for Parties to comply with their substantive provisions under the Protocol. Through decisions adopted by the COP/MOP, the Committee has called on Parties to ensure that they have the legal and administrative frameworks in place to meet their obligations. The Com-mittee has also played a facilitative role in requesting Parties to submit information on any challenges they face with regard to operationalizing their biosafety frame-works. With this information the Committee and the COP/MOP would be in a stronger position to assist Parties to comply.

104 Ibid. Section VI.

105 Ibid.

106 Report of the Compliance Committee under the Cartagena Protocol on Biosafety, UN Doc. UNEP/

CBD/BS/COP-MOP/4/2 (2008), 2.

107 Report of the Compliance Committee under the Cartagena Protocol on Biosafety on the Work of its eighth and ninth meetings, UN Doc. UNEP/CBD/BS/COP-MOP/6/2 (2012), 4.

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3.5 ITPGRFA