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Biosafety refers to the need to protect human health and the environment from the possible adverse effects of the products of modern biotechnology.
The Convention clearly recognizes these twin aspects of modern biotechnology.
1. Access to and transfer of technologies
2. Appropriate procedures to enhance the safety of biotechnology technologies.
Objective
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 sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements.
♤ The Cartagena Protocol on Biosafety is an additional agreement to the Convention on Biological Diversity.
♤ The Protocol establishes procedures for regulating the import and export of LMOs from one country to another.
♤ The Protocol also requires Parties to ensure that LMOs being shipped from one country to another are handled, packaged and transported in a safe manner.
♤ The shipments must be accompanied by documentation that clearly identifies the LMOs, specifies any requirements for the safe handling, storage, transport and use and provides contact details for further information.
There are two main sets of procedures, one for LMOs intended for direct introduction into the environment, known as the advance informed agreement (AIA) procedure, and another for LMOs intended for direct use as food or feed, or for processing (LMOs-FFP).
Advance Informed Agreement
♤ Under the AIA procedure, a country intending to export an LMO for intentional release into the environment must notify in writing the Party of import before the first proposed export takes place.
♤ The Party of import must acknowledge receipt of the notification within 90 days and must communicate its decision on whether or not to import the LMO within 270 days.
♤ Parties are required to ensure that their decisions are based on a risk assessment of the LMO, which must be carried out in a scientifically sound and transparent manner.
♤ Once a Party takes a decision on the LMO, it is required to communicate the decision as well as a summary of the risk assessment to a central information system, the Biosafety Clearing-House (BCH).
LMOs- food or feed, or for processing
♤ Under the procedure for LMOs-FFP, Parties that decide to approve and place such LMOs on the market are required to make their decision and relevant information, including the risk assessment reports, publicly available through the BCH.
Nagoya—Kuala Lumpur Supplementary Protocol
♤ The Cartagena Protocol is reinforced by the Nagoya— Kuala Lumpur Supplementary Protocol on Liability and Redress.
♤ The Supplementary Protocol specifies response measures to be taken in the event of damage to biodiversity resulting from LMOs.
♤ The competent authority in a Party to the Supplementary Protocol must require the person in control of the LMO (operator) to take the response measures or it may implement such measures itself and recover any costs incurred from the operator.
Nagoya Protocol
The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (ABS) to the Convention on Biological Diversity is a supplementary agreement to the Convention on Biological Diversity.
It provides a transparent legal framework for the effective implementation of one of the three objectives of the
CBD.
Objective
Is the fair and equitable sharing of benefits arising from the utilization of genetic resources, thereby contributing to the conservation and sustainable use of biodiversity.
Obligations
The Nagoya Protocol sets out core obligations for its contracting Parties to take measures in relation to access to genetic resources, benefit-sharing and compliance.
Access obligations
♤ Domestic-level access measures are to:
♤ Create legal certainty, clarity and transparency
♤ Provide fair and non-arbitrary rules and procedures
♤ Establish clear rules and procedures for prior informed consent and mutually agreed terms
♤ Provide for issuance of a permit or equivalent when access is granted
♤ Create conditions to promote and encourage research contributing to biodiversity conservation and sustainable use
♤ Pay due regard to cases of present or imminent emergencies that threaten human, animal or plant health
♤ Consider the importance of genetic resources for food and agriculture for food security
Benefit-sharing obligations
♤ Domestic-level benefit-sharing measures are to provide for the fair and equitable sharing of benefits arising from the utilization of genetic resources with the contracting party providing genetic resources.
♤ Utilization includes research and development on the genetic or biochemical composition of genetic resources, as well as subsequent applications and commercialization.
♤ Sharing is subject to mutually agreed terms.
♤ Benefits may be monetary or non-monetary such as royalties and the sharing of research results.
Compliance obligations
Specific obligations to support compliance with the domestic legislation or regulatory requirements of the contracting party providing genetic resources, and contractual obligations reflected in mutually agreed terms, are a significant innovation of the Nagoya Protocol. Contracting Parties are to:
♤ Take measures providing that genetic resources utilized within their jurisdiction have been accessed in accordance with prior informed consent, and that mutually agreed terms have been established, as required by another contracting party
♤ Cooperate in cases of alleged violation of another contracting party’s requirements
♤ Encourage contractual provisions on dispute resolution in mutually agreed terms
♤ Ensure an opportunity is available to seek recourse under their legal systems when disputes arise from mutually agreed terms
♤ Take measures regarding access to justice
♤ Take measures to monitor the utilization of genetic resources after they leave a country including by designating effective checkpoints at any stage of the value-chain: research, development, innovation, pre- commercializa-tion or commercialization
Traditional knowledge
♤ The Nagoya Protocol addresses traditional knowledge associated with genetic resources with provisions on access, benefit-sharing and compliance.
♤ It also addresses genetic resources where indigenous and local communities have the established right to grant access to them.
♤ Contracting Parties are to take measures to ensure these communities’ prior informed consent, and fair and equitable benefit-sharing, keeping in mind community laws and procedures as well as customary use and exchange.
Importance
The Nagoya Protocol will create greater legal certainty and transparency for both providers and users of genetic resources by:
♤ Establishing more predictable conditions for access to genetic resources.
♤ Helping to ensure benefit-sharing when genetic resources leave the contracting party providing the genetic resources
By helping to ensure benefit-sharing, the Nagoya Protocol creates incentives to conserve and sustainably use genetic resources, and therefore enhances the contribution of biodiversity to development and human well-being.
The Biodiversity Target
♤ It was adopted in May 2002 during the sixth Conference of the Parties to the Convention on Biological Diversity.
♤ The Target aimed to achieve, by 2010 ‘a significant reduction of the current rate of biodiversity loss at the global, regional and national level as a contribution to poverty alleviation and to the benefit of all life on earth’.
♤ Unfortunately, we were unable to meet the target. As we are facing an ever-increasing biodiversity crisis, we need a new, clear and realistic target to respond to it.
Strategic Plan For Biodiversity 2011-2020
♤ In the tenth meeting of the Conference of the Parties, held in 2010, in Nagoya, Aichi Prefecture, Japan, adopted a revised and updated Strategic Plan for Biodiversity, including the Aichi Biodiversity Targets, for the 20112020 period.
♤ The tenth meeting of the Conference of the Parties agreed to translate this overarching international framework into national biodiversity strategies and action plans within two years.
♤ Additionally, the meeting decided that the fifth national reports, due by 31 March 2014, should focus on the implementation of the 2011-2020 Strategic Plan and progress achieved towards the Aichi Biodiversity Targets.