Multi-lateral agreements are binding agreements between countries, and sometimes regional groups of countries such as the European Union. The countries and regions that are member of international agreements are called ‘Parties’. The two main multi-lateral agreements that are relevant to biotechnology and biosafety are:
The Convention on Biological Diversity (CBD) was agreed in 1992 and came into force in 1994. The Convention and has currently over 190 Parties.
The objectives of the CBD are: the conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources.
Two articles of the CBD are directly relevant for to biotechnology and biosafety: article 8 and article 19.
Article 8 is titled “In situ conservation of biodiversity”
Article 8.g. contains an obligation to develop and maintain National Biosafety Systems, i.e.: ”Establish or maintain means to regulate, manage or control the risks associated with the use and release of living modified organisms resulting from biotechnology which are likely to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity, taking also into account the risks to human health”;
Article 19 is titled “Handling biotechnology and distribution of its benefits”
The first paragraph of Article 19 requires that each Contracting Party takes appropriate measures to provide for the effective participation in biotechnological research activities by those Contracting Parties, especially developing countries, which provide the genetic resources for such research, and where feasible in such Contracting Parties.
The second paragraph requires that each contracting party to take all practicable measures to promote and advance priority access on a fair and equitable basis by Contracting Parties, especially developing countries, to the results and benefits arising from biotechnologies based upon genetic resources provided by those Contracting Parties.
The third paragraph of Article 19 instructs the Parties to “consider the need for and modalities of a protocol setting out appropriate procedures, including, in particular, advance informed agreement, in the field of the safe transfer, handling and use of any living modified organism resulting from biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity.”
At its second meeting, the Conference of the Parties (COP) to theCBD, in 1995 in Jakarta, Indonesia, the COP decided that such a Protocol was needed and the process of negotiations started in 1996. After 5 years of negotiations, the Cartagena Protocol on Biosafety was adopted in January 2000 and came – after the 50th ratification – into force in September 2003.
The Cartagena Protocol on Biosafety (CPB) is the main international treaty that addresses biosafety. It was adopted in 2000 and came into force in 2003. It has currently over 150 Parties.
The objectives of the Protocol, identified in Article 1 are:
” … 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 Protocol states that it specifically focuses on transboundary movements, and therefore arguably includes the handling and use within a country’s borders. It envisages two different procedures. The first, the Advance Informed Agreement (AIA) procedure, applies to living modified organisms that are intended to be cultivated in the country to which they are transported. The second, for products that are intended for use as food, feed or for processing is a simpler procedure where countries have to inform a central clearing house, the Biosafety Clearing House (BCH), of the internal decision to permit the marketing of these organisms and to provide specific information, including a relevant risk assessment, to the BCH. The AIA procedure essentially requires living modified organisms that are transferred between two countries for the first time to obtain a ‘visa’ before the transfer. Risk analysis may then be needed in the importing country.
Decisions are usually made by Government based on advice received from a number of sources. The risk assessment procedure should be science based. This is made very clear in the Cartagena Protocol. Article 15 states that "Risk assessments undertaken pursuant to this Protocol shall be carried out in a scientifically sound manner". A Royal Society Report in 2002 (The Royal Society, February 2002, Genetically Modified Plants for Food Use and human health – an update, Policy Document 4/02 ISBN 0854035761) asserts that "scientific assessments must inform policy decisions but cannot pre-empt them, and that public opinion must be taken into account throughout. We believe that the public debate about GM food must take account of wider issues than the science alone. We also wish to stress the importance of informing debate with sound science".
Annex III of the Cartagena Protocol identifies the principles for scientific risk assessment that need to be addressed by member countries when considering living modified organisms that might have adverse effects on biological diversity also taking into account the impact on human health. "Risk assessment should be carried out in a scientifically sound and transparent manner and can take into account expert advice of, and guidelines developed by, relevant international organizations”. It provides, inter alia, that "[l]ack of scientific knowledge or scientific consensus should not necessarily be interpreted as indicating a particular level of risk, an absence of risk, or an acceptable risk".
Article 23 of the Cartagena Protocol requires public involvement in the decision-making process and article 26 allows for specific socio-economic issues to be taken into account in the process:
"The Parties, in reaching a decision on import under this Protocol or under its domestic measures implementing the Protocol, may take into account, consistent with their international obligations, socio-economic considerations arising from the impact of living modified organisms on the conservation and sustainable use of biological diversity, especially with regard to the value of biological diversity to indigenous and local communities."
Taken together, the CPB has a number of important functions:
It gives countries that do not yet have domestic biosafety regulations in place a legal basis and a methodology to make informed decisions on import of Living Modified Organisms (LMOs).
It contributes to international harmonisation of national biosafety regulations by international agreement on some of the key elements of domestic biosafety regulations such as definitions, information requirements, principles and methodology on risk assessment, treatment of confidential information etc.
It contains a crucially important mechanism for international information exchange on biosafety through its Biosafety Clearing House (BCH).
The International Plant Protection Convention (IPPC) is an international plant health agreement which was adopted by the Conference of the FAO in 1951. The 173 signatories adhere to the Convention. IPPC developed a standard for living modified organisms (ISPM 11). See also Commission on Phytosanitary Measures under ‘International Standard Setting Bodies’.