A Portal on Biotechnology

International Agreeements and Policies on Biotech

31.01.1999 · Research Group on the Global Future

Bioethic Convention of the Council of Europe
The convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine was ratified on April the 4th, 1997. All Parties to this convention try to protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to the application of biology and medicine. Each Party takes in its internal law the necessary measures to give effect to the provisions of this convention.
(See also: http://www.coe.fr/index.asp)

Biosafety Protocol
After five years of controversial negotiations, over 130 governments finalized on 29th January 2000 in Montreal a legally binding agreement, the Biosafety Protocol, on reducing potential risks from the transboundary movement of life forms that have been genetically modified. The use of modern biotechnology in agriculture has increased with enormous speed over the last years, but its rate of adaptation still differs widely in countries around the globe. The market of genetically modified agricultural products grew from $75 million in 1995 to more than $2 billion last year. The commercial cultivation of genetically altered plants reached 40 million hectares last year compared to 1.7 million in 1996. In 1999, 98% of the genetically altered seeds for commercial use was planted in the United States, Argentina and Canada. While these three countries and a few others are very open to the promises of this new technology like lower production costs, higher yields and less use of herbicides, most countries in Europe and some in Asia take a more cautious view of the possible risks for human health and the environment. The developing countries, owning around 80% of the world-wide biodiversity, fear unacceptable damages to their environment.

Moreover, they are concerned about access issues and afraid of damages to their domestic agricultural sectors. The new biosafety protocol in addition to the UN convention on biodiversity emphasizes the right of countries to make use of the precautionary principle. The protocol establishes a biosafety clearing house for countries to share information about genetically modified organisms and their domestic regulations. For initial shipments of genetically modified organisms intended for release to the environment like seeds and fishes, exporters are required to obtain explicit approval from the importing country in advance. The details for this procedure are fixed in the so-called Advance Informed Agreement (AIA), which is part of the biosafety protocol. For genetically modified organisms intended for food, feed and processing, the AIA-procedure is not required. However, the biosafety protocol provides minimum standards for labeling in international trade. A general labeling standard shall be negotiated two years after the protocol gets into force. In many aspects the new biosafety protocol documents the status quo of the opposing positions. So the controversial question about the relationship between the protocol and the more trade-oriented rules of the WTO is left very vague.
(See also: http://www.biodiv.org)

Capacity-Building
There is no clear definition of the term "capacity building," but it has been recognized to be very important for sustainable development. The aim of capacity building is to set standards especially for developing countries in order to regulate modern biotechnology, for example concerning market access and risk assessment of GMOs. Therefore an international cooperation between all kinds of levels (governmental and non-governmental) is necessary. Many programs and projects related to this issue have been established. However, there are also critical voices that denounce "capacity building" as just another theoretical concept used by the industrial countries to determine how development should be given shape. There are a lot of different modes of knowledge, between the industrial and developing countries. Therefore an interaction between research and knowledge development is seen as a key feature in successful knowledge policy.

Codex-Alimenarius/ Codex Alimentarius Commission
The joint commission of the United Nations Food and Agriculture Organization (FAO) and the World Health Organization (WHO) was established in 1963 to develop an international code of food quality standards. In its first 20 years of activity, the commission compiled hundreds of definitions of foodstuffs and additive restrictions on food. A principal concern of national governments is that food imported from other countries should be safe and not jeopardize the health of consumers or pose a threat to the health and safety of their animal and plant populations. Consequently, governments of importing countries have introduced mandatory laws and regulations to eliminate or minimize such threats. In the area of food, animal and plant control, these measures could be conducive to the creation of barriers to inter-country food trade. But still there are no effective rules or mechanism of sanctions, which could determine worldwide food safety standards. Since the Uruguay Round the WTO also deals with aspects of Food safety.

Convention on Biological Diversity
The conference held by the United Nations Conference on Environment and Development at Rio de Janeiro, Brazil (June 3-14, 1992), wanted to reconcile worldwide economic development with protection of the environment. Its objectives were 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. The Earth Summit was the largest gathering of world leaders in history, with 117 heads of state and representatives of 178 nations attending. It was the first comprehensive goal agreement to address all aspects of biological diversity. Currently, there are 168 signatories to the convention and 175 members of the Conference of Parties.
(See also: http://www.biodiv.org)

Patent
A governmentÔs grant of the exclusive right to make, use or sell an invention, usually for a limited period, usually for 17 to 20 years. Patents are granted to new and useful machines, manufactured products, industrial processes and to significant improvements of existing ones. Patents are also granted to new chemical compounds, foods, and medicinal products, as well as to the processes used in their production. Patents can even be granted to new plant or animal forms developed through genetic engineering. They can also be a part of international agreements.

Precautionary Approach
Policy or other action taken before the underlying science has reached absolute clarity. The precautionary approach emphasizes clean production methods and the prevention of environmental contamination under the assumption that it is cheaper, easier and more practical to prevent pollution in the first place rather than to try to clean contaminated systems later on. This approach is deeply related to and also embodied in the biosafety protocol. When first suggested, precautionary action was intended mainly to reduce marine contamination due to synthetic chemicals and heavy metals, and to halt dangerous activities such as ocean incineration. In only a few years, the preventive thinking behind this principle has spread to broader matters, and may strongly influence paths of development.

Risk assessment
According to the 1992 Rio Declaration on Environment and Development certain principles and rules should guide environmental decision-making, because of the threat of serious irreversible damage to the environment. There has been a great dispute whether measures should be taken even before they are fully proven by scientific evidence or not. Risk assessment is confronted with a dilemma inherent to empirical scientific knowledge production, in terms of how potential hazards are identified. A onehundred percent proof of absence of eventually harmful impacts can never be achieved, due to the inherent limitations of scientific risk assessment. A moratorium could create the space also to include parameters such as what risks are acceptable to gain what benefits. It could furthermore include ethical values and alternative routes in technology development that may lead to the same goal. This would transform the exercise of scientific risk assessment into a negotiation process on technology development, in which different social actors would have to participate. In this sense, both industrialized and developing countries could profit from the public having their say in setting an agenda of risk assessment that goes beyond the limitations of scientific data.

SPS (Sanitary and Phytosanitary Measures) Agreement
During the Uruguay Round, agricultural negotiations strove to lower barriers that countries used to protect their domestic markets. This concern provided a major driving force, which led negotiators to create a separate Agreement on the Application of Sanitary and Phytosanitary Measures. The Agreement which is part of the legal framework of the WTO defines its scope as a function of the objective of the measure, i.e. food safety and animal and plant health protection, as opposed to the type of measure. Consequently, products, processes and production methods are equally covered by its provision. For example, slaughterhouses must comply with strict sanitary standards if the end-users are to receive safe meat products. Sanitary and phytosanitary measures apply to domestically produced food or to local animal and plant diseases as well as to products coming from other countries. Sanitary measures are those related to human or animal health, and phytosanitary measures deal with plant health. The protection of fish and wild fauna, forests and wild flora are included in this definition while the protection, for example of the environment per se and animal welfare is excluded. The SPS Agreement further narrows this broad definition to a limited range of situations. It does not impose any quantitative and legally binding schedules of concessions. It is a set of rules, principles and benchmarks for the WTO Members to ensure, among other things, that sanitary and phytosanitary trade measures are justified and do not constitute disguised restrictions on international trade.
(See also http://www.wto.org/wto/eol/e/wto03/wto3_33.htm)

Sustainability
There are over 100 definitions of sustainability and sustainable development, but the best known comes from the World Commission on Environment and Developments. It suggests that development is sustainable where it "meets the needs of the present without compromising the ability of future generations to meet their own needs". In November 1996 governments and non-governmental organizations from around the world gathered in Rome for the United Nations Food and Agriculture Organization's (FAO) World Food Summit. The conference identified policies needed at the national, regional and international levels to alleviate global hunger and malnutrition.
See also the Sustainability Portal from the Research Group on Global Future.

Agreement on trade related property rights (TRIPS)
Doing research in biotechnology is very expensive. Once a big achievement or invention is gained in this area, it is easy and not very expensive to copy and use the new technology. This brings legal patent standards to the center of the debate. The agreement (TRIPS) recognizes that widely varying standards in the protection and enforcement of intellectual property rights together with the lack of a multilateral framework of principles, rules and disciplines dealing with international trade in counterfeit goods have been a growing source of tension in international economic relations. Part I of the agreement sets out general provisions and basic principles, notably a national-treatment commitment under which the nationals of other parties must be given treatment no less favorable than that accorded to a party's own nationals with regard to the protection of intellectual property. It also contains a most-favored-nation clause, a novelty in an international intellectual property agreement, under which any advantage a party gives to the nationals of another country must be extended immediately and unconditionally to the nationals of all other parties, even if such treatment is more favorable than that which it gives to its own nationals.
(See also http://www.wto.org/wto/legal/ursum_wp.htm#nAgreement)

UNESCO (United Nations Educational, Scientific and Cultural Organization)
The UNESCO has the aim to contribute to peace and security in the world by promoting collaboration among nations in the fields of education, science, culture and communication.
(See also: http://www.unesco.org)

UNEP (United Nations Environment Program)
The organization was established in 1972 to guide and coordinate environmental activities within the United Nations system. UNEP recommends policies to its parent that promote environmental cooperation on an international level.
(See also: http://www.unep.org)