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June 1999 Policy Brief OECD Modern and the OECD

Introduction

How big is biotech? Scientific understanding of how living things are put together and how they grow and develop based on instructions coded in their DNA is advancing rap- Why are so idly. The knowledge already acquired and being accumulated offers mankind prospects for longer, healthier ; plentiful and safe and water; and important? and industry that produce in harmony with the environment.

Are industrial Karl Ereky, a Hungarian engineer, coined the term “biotechnology” in 1919 to applications coming refer to the and the methods that permit products to be produced from raw materials with the aid of living . Although biotechnology is online? often equated with DNA and genetic , it is probably best seen as part of a continuum that began centuries ago, when and began Are modified organisms to be selectively bred and were used to make and wine, safe? cheese and . The cleansing of waste water through microbial degrada- tion, dating from the 19th century, is among the oldest large-scale applications What do we know about of biotechnology by industrial societies. safety assessment? By the end of the 19th century biotechnology was flourishing. Not only had microorganisms been isolated and identified, but Mendel’s work on What are the implications was accomplished and institutes for investigating and other for trade? microbial processes were founded by Pasteur and others. In 1943 the first direct evidence that DNA carried genetic information appeared. The of DNA and the way genetic information is passed from generation to gener- What is OECD’s current ation remained a mystery until and Crick produced their double helix role in biotechnology? model in 1953. “Modern” biotechnology began with their discovery.

Although the advent of modern biotechnology can be dated, there is unlikely How can international to be an end to mankind’s continuous search for deeper understanding and dialogue be improved? more intelligent use of . Today, modern biotechnology plays a role in , fuel production, farming and food preparation, forensics and the For further reading environment.

Since 1980, as biotechnology evolved from a scientific curiosity towards com- Where to contact us? mercial applications, OECD has assisted its Member governments to address the scientific and regulatory issues that came to the fore. This Policy Brief dis- cusses the current state of biotechnology and the role OECD plays on biotech- nology issues. ■

© OECD 1999 Organisation for Economic Co-operation and Development 2 Policy Brief Modern Biotechnology and the OECD

How big plants and to the conservation and into R&D. That means nearly half storage of food. But although food the value of the industry is embed- is biotech? biotechnology is indeed contribut- ded in its intellectual capital. The ing to reducing the cost of food pro- trouble is that intellectual capital is a It is difficult to speak of biotechnol- duction, agro-food applications have plunderable good: it can be stolen ogy as a specific sector or industry. not been as readily accepted as quite easily, copied and then sold Still, the international accounting others have across the OECD area. without authorisation. This some- firm, Ernst & Young, make a pretty times happens in the pharmaceuti- Although consumer trust is a major good attempt at measuring it. In their cals industry, where drugs are annual biotechnology reports they factor, a root cause of resistance to these applications, particularly in imitated and marketed at cut prices, sometimes call it the entrepreneurial particularly in poorer countries. sector and include in Europe, may very well lie in the absence of genuine, here and now, their analysis companies that use Biotechnology companies have to demand pull for biotechnology- modern biotechnological techniques feel that their heavy investment in derived foodstuffs. In the US, genet- to develop products or services. knowledge is worth it, that they will ically modified crops are gaining Companies that use conventional hold the rights to their find- ground. The National Corn Growers biological processes, such as brewers, ings and to profit from them. That is Association estimates that geneti- are not included, nor are non-profit why patenting is important to cally modified corn will account for research institutions. According to researchers; it protects their new 35 per cent of the US crop in 1999. Ernst & Young, 1,036 companies ideas and products and acts as an Genetically modified will were working in the “life sciences incentive for them to continue be seeded on as many as 16 million sector” in Europe in 1997, employing researching. Patenting also encour- hectares in 1999, accounting for more than 39,000 people directly, ages them to be forthcoming with 55 per cent of the crop. And geneti- with revenues of $3.1 billion and the results of their research. Of cally modified cotton will represent $2.2 billion invested in R&D. course there are always trade-offs. about half of the cotton grown. While protection of intellectual In 1998, again according to Ernst & By early 1999, the US had approved property is necessary to promote Young, US companies invested 35 genetically modified crops and , excessive $9.9 billion in R&D, employed many more genetically modified 153,000 people and posted total reve- protection can restrict consumption, and other substances used in nues of $18.6 billion. As for Canada, limit availability and main- food processing. The European Union proportional to its size, it had more tain unnecessarily high prices. had approved nine such crops. companies in biotechnology by 1996 Although trust and economics cur- Innovation in biotechnology origi- (as defined by Ernst & Young) than rently define the scope for genetically nated in universities and start-up either the US or Europe and, in abso- modified crops in Europe, new companies. This was a fragile base, lute terms, more companies involved demands triggered by environmental since these concerns did not have the in agro-. degradation and climate change, in financial muscle needed to market Many and environmental conjunction with population growth, their own goods and ideas. To be able applications either are now or will may well provide an added impetus to license their innovations to large become success stories, scientifi- for the application of biotechnology to companies they turned to intellectual cally, technologically and financially. food and food crops in the future. ■ property protection where it was In the US, for example, according to available. But there lies the rub. For a recent industry estimate, over while there have recently been many 80 biotechnology drugs either are or Why are patents breakthroughs in biotechnology, are about to come on the market. In so important? most of them were unimaginable at agriculture the combination of rising the time when the world’s intellectual population and decreasing produc- The biotechnology industry is par- property protection systems were tivity growth rates clearly suggests ticularly knowledge-intensive. On elaborated, mainly in the 1950s and the long-term need to apply modern average, companies plough some 1960s. Now the interpretation and biotechnology to crop and forage 45 per cent of their annual income application of those rules to biotech- 3 Policy Brief Modern Biotechnology and the OECD

nological innovation has become a innovations with the potential to fuel produced from agricultural major public challenge. improve agriculture risks putting waste, may one day meet a large industry at a competitive disadvan- share of global demand. Unlike con- The challenge facing legislators has tage and slowing research. ■ ventional fuels, bioethanol is not a not been made any easier by the pub- net contributor to greenhouse gases. lic’s unease about health and safety. It is not yet cost-competitive, but One reason for the unease lies in the Are industrial that is expected to change. confusion between property rights in the material sense and intellectual applications Given these benefits it may seem “property” rights, which are in fact coming online? surprising that industrial biotech- temporary rights of exclusive exploi- nology is not more widely used. tation of an idea and not ownership The power of biotechnology as a tool Industrialists have long been con- rights to the product that emerges for industry is increasing rapidly. cerned that biotechnological pro- from it. Patenting might give owner- Novel enzymes, or biocatalysts, re- cesses might be less effective, the ship rights to, for example, the genet- combinant organisms and extremo- costs and risks too high, the scale of ically controlled process leading to a philes – organisms that live under operations too restricted. Although new life form, but in no way does the extreme conditions of pressure or these concerns have receded, bottle- confer ownership rights on the temperature, in deep-sea vents or necks and challenges remain. Scien- life form itself. – have the potential to make tific and technological hurdles must industry cleaner and more efficient. be overcome. Novel processes require In 1999 the OECD published a capital expenditure and development review of intellectual property prac- In addition to its contributions to costs can be high. And there is a tices of its Member countries in the industrial processes, biotechnology shortage of engineers and industrial field of biotechnology. As the study has also led to the creation of a wide designers trained in the relevant bio- shows, OECD countries have range of materials, such as biode- logical processes. ■ diverging approaches to the impor- gradable , biopolymers and tant patenting issues, but these biopesticides, novel fibres and even divergences do not necessarily timbers. Some are used as fabric sof- Are modified imply conflicting policies in prac- teners, corrosion inhibitors, ink car- organisms safe? tice. The OECD survey demon- riers, solvents, hair conditioners and perfumes. The waste from these strates that are used to justify Slowly but inevitably, the surge in manufactured products can decom- patent exclusion in every country in understanding that has illuminated pose more naturally. OECD Europe, as well as in Japan, the life sciences in recent years is Korea and New Zealand. Only Biotechnological processes have transforming the two pivotal indus- Australia, Canada and the United improved and can now compete tries whose very essence is life: food States do not recognise such general with other . They are and health. Downstream from the grounds for exclusion. However, being widely used in the chemicals , agriculture and the the end result is the same, since eth- industry, pulp and paper production, health-care industries have seen ics are invoked to prevent human textiles and leather, food processing their performances heightened and and suffering due to (including animal feed), metals and their competitiveness improved, experimentation. Both of these minerals, and energy. In developed often claiming better value and qual- objectives are pursued in countries countries, these sectors account for ity for the consumer. The health and that reject ethical exclusion through between 30 and 50 per cent of all food sectors are both struggling to laws prohibiting these unacceptable . Biotechnological pro- absorb the flood of new knowledge practices. cesses have helped them to improve and data, in particular that derived their sometimes poor environmental from genome projects (See box on On the other hand, divergences image and, in many cases, increased page 4). over whether plants and animals their efficiency. should be patented carry practical However, these advances have also implications. Withholding intel- One promising prospect is that underlined some key differences lectual property protection for bioethanol, a liquid transportation between the two sectors. Health 4 Policy Brief Modern Biotechnology and the OECD

care is a highly regulated whose products address often life- Genetic modification: the underlying science threatening situations in a context are the instructions that give organ- these conjectured problems have actually where risks and benefits must be isms their characteristics. The instructions arisen. Later that decade, researchers balanced; a context which imposes are stored in each of every living organ- learned how to insert genes into fungi and ethical imperatives on the medical ism in a long string-like molecule called . In the 1980s, they found ways of practitioner, the drug industry and DNA. The full set of instructions is called a putting foreign genes into the cells of genome. All organisms have genomes of vary- plants and some animals. In the 1990s, the the regulatory authority to equip ing sizes; for instance the human genome has first experiments to insert new genes into themselves with the latest know- an estimated 60-100,000 genes; most plants human cells and tissues were developed. ledge. have about 20,000; the nematode worm (a In principle, genetic modification allows microscopic creature) has about 18,000; and researchers to move genes between all living The food sector also deals with bio- the single-celled bacterium has creatures. In practice, so far it has only been logical phenomena – the growth of just over 4,000. made to work in a few animal, , and plants and animals; their protection Our knowledge of genetics allows the iden- microbial species – usually organisms that against infection and ; the tification of individual genes, and often humans have used for many years in agricul- transformation and distribution of understanding of their specific properties. ture, food manufacture and industry. The technique of genetic modification resulting products; safeguarding What is perhaps most surprising about (also known as , and these against microbial or other genetic modification methods is that they genetic manipulation) allows those indi- work at all. How is it possible that genes contamination; fine tuning their vidual genes to be cut out of the genome of from one can be processed by an taste, quality, and acceptability to one organism and pasted into the genome unrelated organism? Because all DNA is the consumer; and studying nutri- of another. composed of the same basic ingredients, a tional and other effects. The new Deoxyribonucleic acid (DNA) is the genetic pasted from, for example, a simple knowledge and techniques are no material of all plants, animals and organism like a can in principle func- and of many . It is made up of just tion in the same way in a more complex less available to the , four building blocks called nucleotides (or organism like a plant. and genome projects on the main bases) – Adenine (A), Cytosine (C), Gua- Modern computer databases containing agro-food plants and animals are nine (G), and Thymine (T). It is the linear huge amounts of sequence data from large- ongoing. sequence of these bases that contains the scale genome projects are making the task genetic information. Rather like Morse of identifying genes with particular desired But thereafter several differences code, only instead of two elements (dots characteristics (e.g. the gene that codes for emerge. Food is familiar, and com- and dashes) the DNA code has four – production of vitamin C in citrus fruit) far forting in its familiarity: we need to A,C,G,T. DNA usually exists as two sepa- easier than in the past. Once identified and rate strands, twisted together in the well- eat every day, and because we are isolated, gene sequences can be cut and known double helix pattern. The genetic pasted into bacteria, which then manufac- creatures of habit the latest innova- difference between species, and organisms ture multiple copies of the genes. This en- tions are not necessarily what we within a species, lies in the different order- ables, for example, the production of essen- want. Innovation may raise suspi- ing or sequence of these bases and the tial like to be produced cions, which regulation may inten- genes that they form. from genetically modified bacteria rather sify rather than dissipate. Thus in In the first genetic modification experi- than from animals. Such insulin is produced the public mind, novelty in food is a ments, which took place in the mid 1970s, in a cleaner, more controllable environ- synthetic human genes were combined ment than was previously the case. Other more sensitive issue than advances in with genes from a bacterium. Many appre- sequences are often introduced at this . hensions of possible dangers were raised at stage, for instance, selective marker genes this time. They were carefully addressed by conferring resistance to one or more antibi- Worries about genetically modified the scientific (in particular at a otics are often linked to the trait genes to foods fall under three general head- noted conference in Asilomar), and none of allow researchers to pick out only those ings. First, that these foods may ☞ unwittingly risk damage to human health. For example, environmental concerns, such as of this concern. Finally, some object resistant genes are sometimes the concern that genes put into to genetically modified food on eth- inserted in genetically modified plants to make them resistant to ical grounds. Here the concern does plants to keep track of them, raising disease and pests may “leak out” not lie with the characteristics of the fear that these genes could into other species. The fear of the product but rather with the way spread to humans. There are also “superweeds” is one manifestation it is produced. ■ 5 Policy Brief Modern Biotechnology and the OECD

What do we know itself. The various plant, animal and animal welfare, the use of geneti- other products by which our ances- cally modified organisms, hor- about safety tors and we have met our needs for mones, the environment and ethical assessment? , fats, and vita- and cultural differences all feature mins had generally not been subject prominently in the public debate. to regulation. Governments have understandably come under intense pressure to For two decades the OECD has been Only as modern or novel technolo- ensure safe food at a minimum cost addressing the problems and contra- gies, such as food irradiation or the to consumers and industry. The dictions of regulating for safety, clar- use of explicitly identified trouble is that the complexity of the ifying the issues and encouraging additives, became available, did pub- issues can make it difficult to iden- the international sharing of experi- lic interest and regulatory attention tify the right policy response, espe- ence and diffusion of best practices. begin focusing on the main food ele- cially in the awkward cases where Considerable experience has accu- ments themselves and the technolog- public opinion is strong and con- mulated in sectors such as the pro- ical processes to which they have vincing scientific evidence is in duction and testing of drugs and been subjected. This poses a funda- short supply. ■ , worker safety, , mental and central question: given , and agri- that we have not regulated the bulk of cultural quarantine. Safety assess- the foodstuffs we eat – raw or pro- ment should build on existing cessed – many of which have entered continued from page 4 knowledge of the organism to which human diet only in recent years, by changes have been made, providing what rationale should we start regu- bacteria that have successfully received clear information about the changes lating the latest innovations in pro- the new gene sequences. Extra regulatory introduced and the intended use. ducts or processing methods? sequences may also be added at this stage, to control the gene’s expression One significant criterion is familiar- To help solve this problem, the prin- i.e. whether it should only in ity with the organism – whether in ciple of substantial equivalence for certain parts of the new host, or “switch the tank, the assessing the safety of novel foods, on” at a certain stage of its development. farmer’s field or in food consump- including those derived through Once the gene is complete within the tion habits, a long history of safe use modern biotechnology, has become “carrier”, it needs to be inserted into the new host. For genetically modified plants is a reassuring and practical starting current practice in many countries. and animals, this stage is complicated by point. At the outset, regulation of the Public concerns about genetically the need to introduce the genes into all new of recombinant modified food and demands for the cells in the organism. This can be DNA and the genetic modification of information led the European Com- achieved by inserting the prepared genes organisms focused on the technol- mission in 1997 to adopt a directive into a single cell of the new host. This single cell can then be cultured into a ogy itself. By the end of the 1980s requiring specific labelling of pro- whole organism in which all the cells the focus had shifted to the end ducts containing or produced from contain a copy of the introduced gene products. The responsibility for genetically modified organisms (the process works similarly if a gene is safety assessment lay with the vari- which are authorised for placement removed instead of added). A number of ous agencies concerned, dealing on the market. Foods or food ingre- methods are used to insert genes into cells. Bacteria and are often encour- with such matters as live vaccines, dients containing or produced from aged with chemical and electrical treat- and environmental modified organisms would not ments, and disarmed viruses can be used impacts of agricultural crop plants require specific labelling if found to to carry genes into animal, plant and and food safety. be equivalent to conventional foods. human cells. There are also direct ways of This has led to considerable dispute taking genes into cells: by injecting them with very fine needles or by forcing them Traditionally, regulatory oversight in within Europe about the precise the food sector had focused on such in aboard tiny metallic bullets. Amazingly, meaning of equivalence. these techniques do not damage cells. ■ matters as residues, contaminants, processing aids, packaging materi- In fact, consumer concerns go well Source: Sir Robert May, als, labelling – everything, in short, beyond basic food safety. The qual- U.K.,Chief Science Adviser, February 1999 except the main elements of the food ity of food and how it is produced, 6 Policy Brief Modern Biotechnology and the OECD

What are What is OECD’s current , or the application of biotechnology to environmental pro- the implications role in biotechnology? tection, has been confirmed as techni- for trade? cally successful and is slowly being OECD’s involvement in biotechnology integrated into routine industrial primarily concerns the three principal applications. Costs are a factor, but so Consumer attitudes to risk and go- domains where it has been applied: is the fact that the speed and perform- vernment approaches to food safety human health, agriculture and food, ance of some environmental biotech- and quality vary significantly from and bioremediation and other envi- nologies are irregular and do not country to country. National safety ronmental applications, including demonstrate the reliability, and quality control systems may not industrial applications. The work is and predictability of physical and be recognised by trading partners. undertaken in various parts of the chemical methods. OECD’s work on National regulations on the use of Organisation. Two units have activities safe drinking water and on industrial pesticides also differ widely. The that are specifically related to biotech- sustainability through biotechnol- stance of OECD countries on bio- nology. The Directorate for Science, ogy continues and extends its long- technology and food range from lim- Technology and Industry addresses standing work on bioremediation. In ited regulation to complete bans. socio-economic issues and issues a further extension of this work, a National standards and procedures related to science and technology pol- major project on biotechnology for can help exporters, because transpar- icy; the Environment Directorate deals sustainable industrial development ent rules facilitate trade. But they can with issues related to regulatory har- is underway, which will provide also reduce international competi- monisation. Other Directorates (espe- guidance to industry and govern- tion, distort markets and prevent cially Agriculture and Trade) have ment on implementing new biotech- firms, notably foreign firms, from programmes that include a biotech- nology applications for industry. entering markets. nology component. To facilitate co- Through its International Collabora- operation among the units engaged in Differences in attitude and regula- tion Programme on Energy Technol- this range of biotechnology-related ogy and R&D, the International tory stances may contribute to trade work, an Internal Co-ordination disputes. The long-standing dis- Energy Agency, an OECD affiliate, is Group for Biotechnology (ICGB) facilitating co-operation among agreement between the European meets three to five times a year. Union and the US and Canada over 17 OECD Member countries and the European Commission on bio-energy. the use of growth in cattle For science and technology policy, Each participating country makes a is one example. The emergence of OECD’s main objective is to provide financial contribution towards admin- such trade disputes has prompted support to the policies of Member istrative requirements, shares the costs countries to look to international countries, particularly in the areas of of managing the tasks and provides in- organisations, such as the World public health, sustainable industrial kind contributions to fund participa- Trade Organization (WTO), for development and biological tion of national personnel in the tasks. solutions. The 1994 Uruguay Round centres, such as culture collections, The work undertaken has contrib- Agreement, for example, guards databanks and . Bio- uted directly to the expanded use of against regulatory protectionism. logical resource centres gather and in European district heating The WTO dispute settlement proce- maintain both the physical collec- schemes, and the application of dure has resolved some international tions of microbial cultures and cell short rotation forestry in Sweden. conflicts and provided guidelines for lines and the closely related electronic regulators, but international dis- databases containing the details of On the environment, safety assess- putes will continue to be arbitrated genomic sequences and other infor- ment is the main focus of OECD work, on a case-by-case basis. The eco- mation. The key policy issue for the with emphasis on the range of culti- nomic stakes are high and food safety OECD and many Member countries is vated crop plants and microorganisms and quality issues, especially given how international co-operation can most commonly the object of transfor- the growing use of biotechnology in contribute to the viability of such cen- mation by modern biotechnology. As some countries, are likely to remain a tres, promote their effective utilisation its name reveals, the Working Group priority on the trade agenda. ■ and conserve resources. on Harmonisation of Regulatory Over- 7 Policy Brief Modern Biotechnology and the OECD

sight, overseen by the Environment plants are evaluated on a case by case late international trade in seed. A Co- Policy Committee, promotes the har- basis, helped by field trials. A key part operative Research Programme aims monisation of regulations and facili- of the evaluation is to consider the to intensify fundamental research in tates trade. The working group environment into which the plant is biotechnology. publishes science-based consensus introduced. Biotechnology features in OECD’s documents that can be used in the relations with non-member countries. environmental risk assessment of OECD’s collective approach to com- Workshops have been held on bio- genetically modified organisms. piling safety information avoids duplication in assessment, which technology research, agricultural Over twenty such “consensus docu- means significant savings for regula- issues and developing country obliga- ments” have been developed using a tory authorities. Literally thousands tions under the Convention on Biolog- standard model and a uniform pro- of genetically modified crop varieties ical Diversity. The Organisation’s cedure, of which eight have been have been or are currently being Internet site (www.oecd.org/ehs/icgb) approved. A country with particular tested in small-scale field trials. Nor- links to Member country biotechnol- interest or experience volunteers to mally, each of these trials requires a ogy sites. Information on biotechnol- act as the lead country on a particu- separate safety notification in each ogy products tested and approved in lar topic and the draft gradually country, and these field tests have Member countries is brought together develops through circulation and already represented over 100 differ- in the BioTrack Online database, which amendment. UN agencies – UNIDO ent combinations of plants and is available to the public on the site and UNEP – participate, and when a traits. Based on the OECD approach, (www.oecd.org/ehs/service.htm). ■ document addresses a plant species a number of plant varieties have whose wild relatives are indigenous been approved for commercial grow- How can international to a particular region, experts in the ing by regulatory agencies in the countries concerned are consulted. , (a non- dialogue be improved? Thus consensus documents are built OECD country), Canada, Australia through a science-based interna- and Japan. However, very few have Apart from work at the OECD, discus- tional dialogue, focusing on the biol- been approved and grown in Europe. sion of genetically modified organisms ogy of the organism and the nature takes place within the Codex Alimen- of the transformation. Trade issues, especially those related to tarius Commission, the joint food intellectual property rights, patenting standards programme of the Food and Typically, three aspects of a geneti- and biological resources management, Agriculture Organization and the cally modified product are exam- as well as new issues arising because of World Health Organization; UNIDO; ined: the biological characteristics of biotechnology derived products enter- the International Organization for Epi- the crop species; the specific trait ing the global market place (such as zootics; the Asia-Pacific Economic Co- introduced through the modification seeds of crop varieties and forest repro- operation (APEC) forum’s Experts – for disease resistance, for instance ductive material resulting from genetic Group on Agricultural Technical Co- – and the potential impact on human modification) are also considered. As operation; the UN Environment Pro- health and the environment. Of part of the work of the Trade Commit- gramme; and in the negotiations of the these three aspects, the first two are tee, a synthesis of national intellectual UN Biosafety Protocol. The hope is generally the same from country to property practices in the field of bio- that regulatory reform and harmoni- country. And it is here that much of technology, referred to above, has been sation will address the problem of the OECD’s work on harmonisation published. The report presents infor- market access, increase consumer is focused. mation from 22 Member countries, confidence in the safety and efficacy the European Commission and the of modified organisms and reduce the The OECD collates scientific evi- European Patent Office. risk of serious trade disputes. dence that is useful for environmen- tal safety assessment, but it makes The Agriculture Directorate supports As part of the 1994 Uruguay Round no overall judgement as to the envi- Member countries with analytical Agreement, the Sanitary and ronmental safety of these plants or work on biotechnology regulation and Phytosanitary (SPS) and Technical genetic engineering processes. The labelling. In addition, the OECD Barriers to Trade (TBT) agreements reason for this is that all modified Schemes for Seed Certification regu- were forged to guard against regula- The OECD Policy Briefs are prepared by the Public Affairs Division, Public Affairs and Directorate. They are published under the responsibility of the Secretary-General 8 Policy Brief Modern Biotechnology and the OECD

tory protectionism, while encourag- satisfy three basic criteria: they are social), among all stakeholders and ing the use of international standards. new, are inventive and have an between OECD and non-member The major exporting and importing industrial or other practical use. countries. countries are observing their obliga- tions, with over 700 SPS measures A recent conference on Biological The international dimension to poli- notified by some 52 WTO Member Resource Management: Connecting cies for clean technology draws its countries, while many low and mid- Science and Policy attracted high- strength from international agree- dle income countries have yet to level attendance from industry, ments and conventions. notify a single measure. government, academia and con- sumer groups to discuss sustainable The 1992 Rio conference on the The WTO incorporates an agreement agricultural systems. Despite wide environment and its Agenda 21 were on trade-related intellectual property differences of view, there was agree- milestones, because governments arrangements, called TRIPs. It pro- ment on the need for increased co- acknowledged that a balance must vides intellectual property protection ordination and dialogue between be struck between globalisation and to product and process inventions that disciplines (science, economic, sustainable development. ■ For further reading

■ Xenotransplantation: International policy Issues,1999, ■ Biotechnology for a Clean Environment: ISBN 92-64-17030-8, US$27, pp.116. Prevention, Detection, Remediation, 1994, ■ Novel Systems for the Study of Human Disease: ISBN 92-64-14257-6, US$68, pp.202. From to Applications, 1998, ■ Aquatic Biotechnology and Food Safety, 1994, ISBN 92-64-16011-6, US$26, pp.400. ISBN 92-64-14063-8, Us$18, pp.100. ■ Biotechnology for Water Use and Conservation: ■ Traditional Crop Breeding Practices, 1994, The Mexico ’96 Workshop, 1997, ISBN 92-64-14047-6, US$ 60, pp.236. ISBN 92-64-15594-5, US$78, pp.728. ■ ■ Safety Evaluation of Foods Derived by Modern Biotechnology, Food Safety Evaluation, 1996, 1993, ISBN 92-64-13859-5, US$19, pp.80. ISBN 92-64-14867-1, US$36, pp.180. ■ Safety Considerations for Biotechnology: ■ Intellectual Property, Technology Transfer and Genetic Resources: Scale-up of Crop Plants, 1994, An OECD Survey of Current Practices and Policies, 1996, ISBN 92-64-14044-1, US$12, pp.40. ISBN 92-64-15328-4, US$16, pp.86. ■ Field Releases of Transgenic Plants, 1986-1992, An Analysis,1993 ■ Wider Application and Diffusion of Bioremediation Technologies: ISBN 92-64-14046-8, US$12, pp.40. The Amsterdam ’95 Workshop, 1996, ISBN 92-64-14869-8, US$72, pp.456. ■ Safety Considerations for Biotechnology, 1992, ■ Gene Delivery Systems: A State-of-the-Art Review, 1996, ISBN 92-64-13641-X, US$18.50, pp50. ISBN 92-64-14887-6, US$59, pp.446. ■ Biotechnology, Agriculture and Food, 1992, ■ Environmental Impacts of Aquatic Biotechnology, 1995, ISBN 92-64-13725-4, US$43, pp.220. ISBN 92-64-14666-0, US$35, pp.172. ■ The OECD’s consensus document series – which is intended for use in ■ Safety Considerations for Biotechnology: regulatory assessments of products of modern biotechnology is Scale-up of Microorganisms as Biofertilizers, 1995, available for downloading free-of-charge from OECD's ISBN 92-64-14344-0, US$19, pp.68. Biotechnology website at www.oecd.org/ehs/icgb/. A number of other important documents such as those related to intellectual ■ Bioremediation: The Tokyo ’94 Workshop, 1995, property rights are also available for downloading from this site. ISBN 92-64-14634-2, US$116, pp.654.

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