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This analysis looks at lessons learnt from the 132 countries that participated in a UN and Global Environment Facility project supporting developing countries to design and implement national biosafety frameworks.

The report examines how participating countries tailored their regulations to meet national development priorities, policy contexts and legal and institutional frameworks. It describes different approaches to promoting public awareness, education and participation. A key message is the need to include all relevant stakeholders in the regulatory design and implementation.

This report may help other policymakers design biosafety regulations of their own and demonstrates how national priorities can be balanced against international obligations.

This collection of seven policy briefs summarises recent research on the potential for transgenic improvement of banana and maize crops in East Africa. It is part of a series of briefings produced by the International Food Policy Research Institute and two other centres.

The collection provides a helpful overview of practical and inter-disciplinary research relevant to the two crops, and highlights key issues for evaluating the potential application of genetically modified technology.

The first article introduces the collection and highlights key issues. Subsequent articles assess the systems for disseminating new planting material and gauge the potential demand for transgenic banana and maize varieties in the region.

The last three articles look at biosafety risks and crop biodiversity.

This document summarises the ninth email conference of the Food and Agriculture Organization's e-forum on biotechnology, which took place from 28 April to 1 June 2003. The conference focused on the regulation of genetically modified organisms in the developing world. Forty-four participants from 20 countries contributed to the discussion. About half of these were from developing countries.

The topics raised during the conference included resource and capacity issues, approaches to risk assessment and management, the desirability and practicality of harmonising international regulations, public participation, liability and enforcement. The summary contains links to a full archive, where readers can access the original messages.

The breadth of topics covered makes this e-conference a useful starting-point for anyone wanting a quick summary of the key issues arising from the regulation of genetically modified organisms in developing countries, and gives a good idea of the areas of consensus and disagreement.

This special issue of the International Journal of Technology and Globalisation  includes nine articles by prominent researchers and policy analysts. The papers emerged from a research project entitled Making Biotechnology Work for Human Development.

As the editor, Sakiko Fukuda-Parr, explains, the articles focus on how diffusion of GM crops in developing countries is being shaped by both global and local institutions (including markets and regulations), actors and processes.

The volume covers a range of important issues, including intellectual property rights, international trade, benefits and risks, impacts on small farmers, the role of the private sector and the costs of regulatory compliance. It sheds new light on both current trends and future prospects for genetically modified crop development and commercialisation in the South.

The Food and Agriculture Organisation prepared this background paper for its 24th regional conference for Africa held in Bamako, Mali. It introduces African policy-makers to some of the key issues that need addressing in biotechnology.

The report first reviews the main international, regional and national policy and legal instruments for genetically modified products in Africa. It then discusses policy issues and options arising from the production, safety assessment, handling and labelling of genetically modified organisms in Africa, including mechanisms to encourage and facilitate regional harmonisation of regulatory approaches.

In particular, the document examines issues of liability and redress, the incorporation of socio-economic considerations in decision making, intellectual property concerns and research priorities. The paper concludes with some general recommendations and guidelines for further policy analysis and decision-making.

In this discussion paper, Gregory Jaffe of the International Food Policy Research Institute (IFPRI) evaluates the biosafety frameworks of Kenya, Tanzania and Uganda against a set of nine basic principles that should characterise a "functional and protective" biosafety system. His analysis also takes into account the obligations laid down by international agreements such as the Biosafety Protocol, World Trade Organisation rules and the Codex Alimentarius.

The report recommends a number of specific improvements for each of the three countries' biosafety systems. The author also evaluates the scope for standardisation among the three countries, with a view to streamlining decisions and making best use of limited scientific and regulatory capacity.

The report will be particularly useful to policy-analysts, scientists, business-people and journalists in East Africa who want to know about the biosafety systems in the three countries, and to anyone who wishes to understand more about the basic principles of biosafety regulation in general.

Global trade in genetically modified (GM) food and feed products is affected by a confusion of international rules, the regulations of major importing countries and the demands of consumers. This discussion paper from the International Food Policy Research Institute aims to clarify the policy options available to developing countries and show how they can take advantage of the opportunities created by GM crops.

The document begins with a helpful summary of the major international rules and institutions governing international trade in GM crops and describes the uncertainty that surrounds the potential areas of conflict between the different sets of rules. The author then reviews the regulatory systems of two major importing powers – Japan and the European Union – and briefly assesses their influence over exporting countries and the pattern of global agricultural commodity trade.

In the light of his analysis, the author identifies four policy recommendations that should enable developing countries to remain in conformity with international rules while balancing the promotion of export opportunities against the productivity and economic advantages of GM crops for farmers and consumers. Policy analysts, students and teachers may find this document particularly useful.

In this paper, Deborah Delmer of the Rockefeller Foundation addresses the “disconnect” between fundamental research generally, and its application in the field. She notes that the health sector is now getting to grips with the problem, and advocates a similar approach in agriculture. However, this approach, which is usually described as “translational biology”, faces obstacles such as culture differences between academia and the private sector, IP and dissemination, and monitoring of crops in developing countries.

The author discusses “harnessing the of new sciences for crop improvement such as molecular breeding and genetic modification (GM), and argues for the need to develop crops with traits relevant to the needs of developing countries. These would include crops that are nutritionally enhanced, able to extract more nutrients from the soil, or tolerant to attack by pests.

The report concludes with a call for better collaboration in order to improve the strategic selection of projects likely to have the highest impact for farmers, and to help scientists identify the best approaches to their research, as well as encourage them to use techniques that are likely to gain regulatory approval. Finally, Delmer says, substantial new sources of funding will be needed to translate fundamental research findings to the field.

This report analyses key issues surrounding decision-making on GM crops in developing countries. The document was written by Ehsan Masood and others as part of Panos’ Communicating Research through the Media Programme, Relay.

Using case studies from Brazil, India, Kenya, Thailand and Zambia, the report explores how policies and regulations are developed, and who is involved in decision-making processes around GM technology. The authors look at the role played by scientists, international bodies, industry and farmers’ groups and the degree of public participation in decision-making, noting that scientific expertise is most influential throughout the process.

The document also examines the degree to which the media succeeds in performing its key role as facilitator of informed debate. In presenting evidence from their survey of media coverage of GM issues in the countries studied, the authors find a general lack of analytical reporting, with many journalists simply relaying government announcements. Farmers’ viewpoints are generally under represented.

This useful and informative report provides real-world examples of decision-making processes on GM in a variety of developing countries. It will be valuable to anyone interested in such processes or in how well the media supports them.

This document summarises the 12th email conference of the FAO’s e-forum on biotechnology, which took place during January and February 2005. The topic was public participation, and particularly the involvement of people in rural areas. Some 70 international participants contributed to the discussion, and the points they raised are summarised here.

These include the appropriate degree and nature of involvement by rural people in policy-making on issues to do with genetically modified organisms (GMOs); the type of information such groups would need in order to participate effectively; the quality of such information and the problems caused by ‘misinformation’ about GMOs; and the appropriate channels and mechanisms for engaging with rural groups, along with the costs involved.

As with all the FAO e-forum conferences, this discussion provides a valuable insight into the range of opinions, experience and expertise involved in the process of public participation, seen from both an international an local perspective. The document therefore provides a valuable introduction to the areas of consensus and disagreement, which policy-makers, journalists, educators and others will all find useful.

This series of briefing documents is based on a three year research programme into policy and governance issues surrounding agricultural biotechnology, especially GM crops, in developing countries. The research involved collaborators from the UK, China, India, Kenya and Zimbabwe. Co-funded by DFID and the Rockefeller Foundation, the series was coordinated by the Environment Group at the UK’s Institute of Development Studies.

The series consists of thirteen concise summaries focusing on particular topics, such as corporate dominance, biosafety regulation, intellectual property rights and public participation in decision-making. Specific briefings also discuss biotechnology in African farming and experiences with insect-resistant cotton in China, India and South Africa. The series draws together various dimensions of the debates about agricultural biotechnology in the context of development. The authors address the complex socio-economic issues surrounding the adoption of GM technology in the South, and frequently sound notes of caution about the likely benefits for the poor.

Of interest to policy-makers, academics and anyone interested in understanding the global socio-economic and development implications of agricultural biotechnology in developing countries.

More than fifty crops have now been genetically transformed – in the laboratory – in sixteen developing countries. However, regulatory approval and cultivation lags well behind the developed world, having only taken place in a handful of countries, and being restricted to just two crops – cotton and maize. This International Food Policy Research Institute policy briefing discusses some of the reasons for this.

In food safety assessment, developing countries face two problems: weak institutional, infrastructural and technological capabilities; and the lack of common international standards. This creates difficulties for developing countries in relation to their participation in international trade, particularly in terms of: operationalising the concept of 'substantial equivalence' (in which the novel characteristics of a GM product are evaluated against its non-GM counterpart); accessing safety data generated in other countries; building capacity to meet demanding international standards or importers’ requirements; and establishing food safety thresholds.

The authors note that safety assessment is not just about science, but about public perceptions and assuring importers about food safety. Nevertheless, they argue that credible science and reasonable international standards will "allow scientifically defensible decisions in the face of food safety questions coloured by each country’s perceptions and circumstances".

This article documents research carried out in the Philippines and Mexico between 1997 and 2001, on stakeholder attitudes towards agricultural biotechnology. The paper argues that a lack of such research contributed to the emergence in the North of inaccurate stereotypes concerning the way that agricultural biotechnology is perceived in the South.

The article describes the methodology used in the surveys and discusses some of the initial findings. Although many concerns were shared across the two countries, there were also striking contrasts. For example, opinions appeared to be more polarised in the Philippines than in Mexico. In both countries, however, academic institutions appeared to be key players and mediators in debates about biotechnology.

The article concludes that prevailing knowledge, perceptions and interests in the two countries often differed from those in developed countries. In addition, differences in attitudes and perceptions between the Philippines and Mexico were linked to political, cultural and institutional factors as well as historical experiences. The author concludes that any global system of governance for biotechnology needs to take into account the specific circumstances and characteristics of individual countries.

This report summarises a conference hosted by the Centre for Social and Economic Research on Innovation in Genomics (INNOGEN), based in Edinburgh, United Kingdom. The conference brought together people who had been involved in the UK’s public debate on biotechnology in agriculture ("GM Nation") and various interested stakeholders, to discuss the lessons arising from the UK dialogue on GM crops.

The conference pointed to a number of implications for policy makers. For example, the report suggests that focusing discussions on GM crops as a distinct area may be unhelpful, because the issues involved are intimately connected to much wider concerns about agricultural production and consumption worldwide. Reconciling public concerns with national and international regulatory frameworks and restoring public trust in decisions are key challenges.

This report provides a concise and accessible overview of the issues emerging from the UK's experience. It highlights points of consensus and disagreement between different stakeholders and identifies lessons that could be learned about the design and organisation of similar dialogue processes, and the part they might play in supporting future decision making around complex and controversial science and technology issues.

This paper was prepared by Julian Kinderlerer as a background document for the United Nations Environment Programme (UNEP) – Global Environment Facility (GEF) Project on the development of national biosafety frameworks. It discusses the key issues involved in the regulation of biotechnology at the international level, and in particular the requirements of the Cartagena Protocol on Biosafety, which lays down rules governing national-level regulations for the international movement of genetically modified organisms.

The paper discusses the background to biotechnology regulation in Agenda 21, the Convention on Biological Diversity and the Biosafety Protocol; developments in biotechnology in different parts of the world, including differences in regulatory approaches between different countries; the need for science-based decision making; and key concepts such as risk assessment and risk management.

The paper concludes with a list of the administrative systems and steps that the Biosafety Protocol requires countries to put in place for their national biosafety regulatory frameworks. The UNEP–GEF project has now moved ahead to the implementation phase, but this document remains a useful reference for key concepts and basic requirements in biosafety risk assessment and regulation.

This FAO 'working paper' - which was prepared as background material for the 2003 issue of The State of Food and Agriculture - discusses concerns that private sector dominance of biotechnology research and the extensive patenting of new discoveries prevent poor farmers from benefiting from biotechnology.

The authors, Carl E. Pray and Anwar Naseem of Rutgers University, United States, provide a focused overview of the status of crop biotechnology research worldwide and analyse the influence of intellectual property rights (IPRs) on diffusion of the technology. They explore the idea of an optimal degree of 'appropriability' that maximises the total social value of biotechnology research and which yields a socially desirable distribution of the benefits.

The paper then describes various policy measures that could focus more biotechnology research on the problems of the poor, in both the public and private sectors and through public private partnerships. Specific recommendations include that groups are developed to lobby for the interests of the poor, and that "more efficient" biosafety regulations and stronger IPRs are established to encourage privately funded research. 

A related paper - The Economics of Agricultural Biotechnology Research - provides more detail on the economic determinants and impacts of agricultural research, and surveys public and private research in both developed and developing countries since the green revolution.

These two highly informative papers - which offer overviews of current status and regulations and of ecological risk assessment - are an excellent overview of the current status of GM crops in commercial production, as well as those that have been approved for release. The regulatory mechanisms surrounding the release of GM crops in different countries are compared, followed by a balanced discussion of the issues surrounding risk assessment and its role in decisions involving GM technology.

The first paper contains a comprehensive list of over 40 transgenic crops approved for commercial release, and discusses legislation in the United States, Argentina, Canada, China, the European Union, Australia, Japan and other countries. The authors caution against "the regulation of risk turning into the risk of regulation", which would lead to a situation in which only a few multinational companies could afford to tackle excessive regulatory processes.

The science of risk assessment is addressed in the second paper, concluding with the socio-economic context of judgements surrounding GM technology. The various concerns regarding the environmental release of transgenic crops are thoroughly discussed, including the likelihood and possible consequences of the invasion of existing ecosystems, outcrossing, horizontal gene transfer, 'superpests' and secondary ecological impacts on biodiversity and other agricultural practices.

The authors emphasise that the plants developed by traditional breeding offer the most appropriate reference point against which the potential impact of a GM crop should be judged, and that these judgements must be made on a case-by-case basis.

Part of IFPRI’s annual report (2000-2001), this detailed essay attempts to counter claims that the application of intellectual property rights to agricultural research may leave farmers in the developing countries 'out in the cold'. They say that agricultural researchers in many developing countries are freer than one might think to make use of innovations protected in developed countries.

The authors conclude that concerns that patents and other forms of intellectual property are constraining the 'freedom to operate' in developing countries are largely misplaced, and are actually diverting attention from more crucial issues for agricultural researchers working on staple food crops.

This general overview illustrates the importance of effectively managing intellectual property (IP) and tangible property (TP) in the development of biotechnology-based products. It also emphasises the value of partnerships between the public and private sector in projects aimed at helping developing countries, as these nations often lack the capacity and resources to manage such issues.

As well as providing helpful definitions of legal and technical terminologies, the authors use a real and a fictional case study to demonstrate the various issues that inventors should consider. Examples include knowing the origins of every component of the product or system, any associated licences and patents, identifying ownership of resources, and having a suitable recording policy in laboratory notebooks, as well as awareness and training among staff.

As yet there is no international patent system, meaning that extra considerations must be taken when attempting to transfer technology across the globe. This has an impact on products destined for developing countries that must be taken into account early in the development process. However, the authors advise against undue anxiety relating to IP and TP. They stress that these issues should be viewed as simply another aspect of life in modern research laboratories, both in developing and industrialised countries.

Farmers and consumers have benefited from advances in agricultural technology for centuries, but the most recent innovation — transgenic modification of crops — has generated enormous controversy.

It is well known that whereas genetically modified (GM) crops have been grown extensively in Argentina, Canada, and the United States since 1996, environmental and consumer groups have largely blocked the GM crop revolution in Europe and Japan. It is less clear, however, what choices developing countries will make concerning the new technology.

In this discussion paper, Robert L. Paarlberg devises a system for classifying policy choices towards GM crops in the areas of intellectual property rights, food safety, biosafety, trade, and public research investment.

He then presents a snapshot and analysis of policies toward GM crops for four countries: Brazil, China, India, and Kenya. At the time of writing, of these four countries, only China had officially approved the commercial planting of GM crops.

Paarlberg seeks to explain the differences among the four countries in these policy areas, and he determines that international pressures — from, for example, international environmental and non-governmental organisations, international agreements, and donors — have discouraged GM crop adoption in Brazil, India, and Kenya. China has taken a different path in part because it is relatively insulated from such pressures.

This study should be of great interest to any one who follows the international debate over GM foods and crops, including policy-makers, researchers and students, and those in the international private sector.