ADOPTION OF PROTOCOLS
The Convention provides a legal framework for a achieving its objectives and goals. It allows for these to be further developed into binding obligations by additional legal instruments called `protocols'. At the time of negotiation, the only area that was identified as the possible subject of a protocol was the question of biosafety. Since then however, the Conference of the Parties has affirmed its willingness to consider the possibility that a revised International Undertaking on Plant Genetic Resources take the form of a protocol to the Convention, should the FAO so decide. It has also stated that it would consider the option of developing a protocol for the full and effective implementation of the Convention's provisions concerning alien invasive species.
Suggestions for meeting other goals through the form of protocols have also been made by individual Parties and organizations, but have not yet been considered by the Conference of the Parties.
Biosafety
Paragraph 3 of Article 19 of the Convention states that the Parties shall consider the need for a protocol in the field of the safe transfer, handling and use of any living modified organism resulting from biotechnology that may have an adverse effect on the conservation and sustainable use of biological diversity.
The Conference of the Parties turned its attention to biosafety at its first meeting, and decided to seek advice from experts on the need for, and possible formulation of, a protocol. A panel of fifteen experts met in May 1995 and a larger group of experts convened in July of that year. Following advice from these, the second meeting of the Conference of the Parties established an Open-ended Ad Hoc Working Group on Biosafety (known as the Biosafety Working Group) to develop a protocol. The working group, which was directly answerable to the Conference of the Parties, met six times from July 1996 to February 1999. The main areas of disagreement in the negotiations were: the extent to which the protocol should cover products of living modified organisms, specifically those intended for food or animal feed, or for processing; issues of liability and redress; and the extent to which socio-economic implications of the use of living modified organisms should be addressed.
The final meeting of the working group was held in Cartagena, Colombia, in February 1999. An extraordinary meeting of the Conference of the Parties was held immediately after this, on 22 and 23 of February in Cartagena, with the aim of concluding the protocol. However, a number of issues remained outstanding and the Conference of the Parties therefore decided to suspend its extraordinary meeting. Informal consultations on the protocol were held in Vienna in September 1999 and in Montreal in January 2000. The extraordinary meeting was resumed in Montreal immediately after the latter and the protocol was adopted on 29 January.
The Cartagena Protocol on Biosafety specifically focuses on transboundary movements of living modified organisms that may have adverse effects on the conservation and sustainable use of biological diversity. Those that are to be intentionally introduced into the environment are to be subject to an advanced informed agreement procedure in which the exporter must provide detailed information to each importing country in advance of the first shipment, and the importer may then authorize or refuse the shipment. Shipments of such organisms are to be accompanied by documentation containing information specified in the protocol. Under Article 15 of the Protocol, Parties of import may require the exporter to carry out a risk assessment and may also require that the notifier bear the cost of the risk assessment.
Living modified organisms intended for direct use as food or feed, or for processing, are subject to a simplified procedure in which a Party informs others of its decision regarding domestic use of such organisms via a Biosafety Clearing-House. Documentation accompanying shipments of such organisms must identify that they “may contain” living modified organisms. Other requirements of documentation accompanying these shipments are to be determined in the future by the Conference of the Parties serving as the meeting of the Parties to the Protocol. Living modified organisms that are destined for contained use are exempt from the advanced informed agreement procedure but are also to be labelled with information specified in the protocol. Living modified organisms that are pharmaceuticals for humans are exempt from the protocol.
The issue of liability and redress remains unresolved. Under Article 27 of the protocol, the Conference of the Parties, acting as the Meeting of the Parties to the Protocol (MOP), is to elaborate appropriate rules and procedures, if possible within four years of the protocol entering into force. With regard to socio-economic considerations, the Parties have decided that an individual Party may take into account, consistent with their international obligations, socio-economic considerations arising from the impact of the use of living modified organisms on biological diversity, when deciding whether to permit an import or not.
The protocol is open only to Parties to the Convention, 103 of which had signed it by August 2001. It will enter into force on the ninetieth day after the deposit of the fiftieth instrument of ratification, acceptance, approval or accession.
Biosafety Clearing-House
The Protocol established a Biosafety Clearing-House (BCH) under the clearing-house mechanism of the Convention, in order to facilitate the exchange of scientific, technical, environmental and legal information on, and experience with, living modified organisms; and to assist Parties to implement the Protocol. At its first meeting (December 2000), the Intergovernmental Committee for the Cartagena Protocol (ICCP) recommended that the BCH should be established in a phased manner beginning with a pilot phase, guided by the principles of inclusiveness, transparency and equity, and that the pilot phase be open to all governments and address the mechanisms for both electronic and non-electronic information sharing.
The ICCP identified the objectives of the pilot phase as:
- Building experience and providing feedback for the development of a functional and accessible internet based BCH; and identifying alternatives to the electronic system; and
- Identifying and addressing the capacity needs of countries with respect to the BCH.
It also recognized that the clearing-house mechanism and the Biosafety Clearing-House have distinctly different roles, and recommended that at the technical and operational levels, the Biosafety Clearing-House shall be run as a distinct element. It requested the Executive Secretary to seek the appropriate administrative arrangements with relevant international organizations, such as the OECD and UNIDO, and Governments and that during the pilot phase use is made of existing information systems, such as the use of the ICGEB database and the OECD/UNIDO databases, including the product database, as models.
The relationship between the Protocol and the WTO
The commercial development of biotechnology has spawned multi-billion-dollar industries for foodstuffs and pharmaceuticals that continue to grow at a dramatic pace. Under World Trade Organization (WTO) regulations, the regulation of trade must be based on “sound scientific knowledge”. Under environmental regimes, the precautionary approach is seen as an indispensable component of sustainable development.
The WTO also does not accept socio-economic concerns, such as the risk that exports of genetically engineered crops may replace traditional ones and undermine local cultures and traditions in importing countries; however, this forms part of the risk assessment under the Biosafety Protocol. The subsidiary agreements of the WTO, including the Sanitary and Phytosanitary Agreement (SPS), Technical Barriers to Trade Agreement (TBT), and the Agreement on Trade-Related Intellectual Property (TRIPs), also contain specific provisions that apply to the biosafety issue.
Among other things, the Preamble to the Protocol:
- Recognizes that trade and environment agreements should be mutually supportive;
- Emphasizes that the Protocol doesn't change rights and obligations under existing agreements; and
- Understands that the Protocol is not subordinate to other international agreements.
