Regulating biotechnology

In designing regulations for the use of biotechnology governments are expected to balance the risks and benefits of GM crops to the public and determine whether biotechnology addresses the development needs of their country. However, they are increasingly faced with global pressures regarding the scope, depth and enforcement of their biosafety regulations. There is a danger that in the push to accommodate trade concerns and the demands of GM crop exporters, countries are losing an important opportunity to define for themselves how biotechnology may assist their development.

Countries are faced with inconsistent messages from international biotechnology organisations which place different emphases on the balance between trade, environmental protection and food security. These include the Cartagena Protocol on Biosafety and the World Trade Organisation agreements on standards, agriculture and intellectual property rights. Amid this confusion, however, there is pressure for countries to adopt standard approaches to risk assessment and regulations that cause the least disruption to trade. This pressure is reinforced by countries exporting GM crops, which use international aid and the threat of trade action to put pressure on weaker governments in non-compliant countries. There is also pressure from the biotechnology industry to agree to a narrow system of biosafety regulations that cause minimal disruption to the international trade in GM crops. These regulations prioritise market access, a 'one-stop' approval process, and strong forms of intellectual property protection for their products.

If, in designing an appropriate regime for biotechnology governance, we consider the twin goals of environmental protection and food security, a different set of global instruments and priorities may be envisaged. What is needed is an approach that accepts the need for risk assessments tailored to different agricultural and ecological situations, and which upholds the rights of countries to decide which risks they consider most important.

Key challenges for regulation include:

• l Speed of the approval process. Governments are under pressure to speed up their processes for approving biotechnology applications, or run the risk of losing investors. However, experience from the UK and India suggests that a rushed process provokes public concern about inadequate consideration of all possible social and environmental impacts and creates perceptions of a technology being imposed from outside.
• l Scope of the process. Trade agreements seek to restrict the nature of risk assessment procedures to narrow 'sound-science' criteria. While this makes sense for global commodity traders, it may not allow for adequate consideration of environmental uncertainties or the possible socio-economic implications of introducing the technology into a country.
• l Participation in the process. While governments are obliged to engage the public in designing biosafety regulations, consultation is often limited to a small group of experts from the scientific community and private sector. Meaningful participation requires more ambitious and targeted strategies that create genuine opportunities for people to question new technologies.
• l Policy implementation. International agreements and national regulations mean nothing if they are not enforced. Yet, across the world, there is evidence of illegal growing of GM crops and of a seed trade that governments cannot adequately monitor, resulting in costly legal suits and loss of trust in regulatory systems. Building an effective scientific and bureaucratic capacity is vital.

In designing regulatory systems, governments are faced with trade-offs between domestic priorities and international commitments, between a desire to promote biotechnology and a responsibility to reduce and manage risks. The only way a country can regulate biotechnology in its own interests is to develop a coherent national strategy where biotechnology is judged in relation to its potential to support broader development goals, such as food security and poverty alleviation.

Peter Newell
Institute of Development Studies
University of Sussex
Brighton, BN1 9RE
UK
p.newell@ids.ac.uk

See also

Newell, P. (2003) Biotechnology and the politics of regulation. IDS Working paper 146

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