Biotechnology, International Competition, and its economic, ethical and social implications in developing countries

chapter 14 in Concepts in Biotechnology, (Universities Press Pvt. Ltd, Orient LongMan Inc., India, 1996).
Author: Darryl R. J. Macer


Biotechnology has been promoted by many as essential for human survival and as a technology that will improve the quality of people's life in every country. In previous chapters of this book we have seen the great potential of biotechnology, and how some of this has already been realised. This has already had an effect on developing countries, which have been said to lose US$10 billion annually from their exports due to biotechnology-based product substitutions (1). International competition implies that there may be some winners and losers in the competition, and it is not yet predictable whether these will be developing or industrialised countries, the producers or users of techniques (2), the poor or rich within countries, or even how it will change international relations. Although we hope that biotechnology can improve life for every person in the world, and allow more sustainable living, the crucial decisions may be dictated by commercial decisions, and by the socio-economic goals that society considers to be the most important. In this chapter these aspects, together with some of the social and ethical implications of biotechnology, will be highlighted.

Biotechnology and International Trade

Biotechnology can be defined as the use of biological systems (in vitro or in vivo) to provide, or improve, goods or services. In ancient and modern times, people have used biological organisms to provide food, drink, medicine, clothing, fuel, and to extract metals. The diversity of uses is expanding. Biological organisms have been selected to optimise these roles, with plant and animal breeding, and microbial selection. In addition to the organisms that have been directly selected by human action, other organisms ecologically favoured by the presence of those organisms have been indirectly selected.

Whether countries can use new biotechnological techniques to improve life depends on several major factors. There must be a social acceptance and willingness to use new technology. There must be sufficient resources to allow its use. It must be user friendly. There needs to be trained personnel to introduce the technology so that ordinary people can use it effectively, and training of farmers to use new cultivation systems. The barriers that slow the adoption of better techniques and/or varieties should be removed, and conservatively-minded policy makers, dictatorial scientists, and village elders should accommodate biotechnology to boost sustainable local production. These are national questions, but international aid is required to allow research, and to introduce new technology, in smaller countries. There are also international questions, such as whether technology is transfered from countries with a high level of research capability to countries that do not, and how, if at all, intellectual property rights should be protected.

Human plant and animal breeding is associated with commerce. International trade for many countries has long been based on biological products. International trade pressures have changed the internal structure of many countries, and they will continue to do so. The obsession to repay ever increasing loans has had enormous social consequences in many countries, both industrialised debtors and developing countries. International competition has become intense, to export products to gain foreign exchange. It is into this framework that the further use of biotechnology must be viewed, and there could be both positive and negative effects for different countries. Biotechnology will affect every area of countries' economies (3). Some examples of these effects on developing countries are in Table 13-1.

The goals of every country may be similar, to raise the quality of life of their citizens, and to maintain living standards at a reasonable level. The perceived method for obtaining the first goal is economic success in the international competition, though living standards in many industrialised debtor countries could be considered better than those in some countries successful in the international competition. The maintenance of living standards, however, does require some success in the world competition. The maintenance of reasonable lifestyles and quality of the environment, that is consistent with a sustainable way of life in the international community, should be a primary goal of many countries. When more industrialised countries accept this, there may be increased attention given to the questions of distributive justice in the world. International competition should be adjusted to encourage more sustainable economic policies (4), the environment of the planet when we do reach a steady-state will be better the quicker this is done. Until that time, international competition will continue, and some countries will be able to improve their international trade, and others will not.

Developing countries are currently economic losers in international competition, so many would say that the situation can only get better. However, if commercial forces are left to operate unconstrained by morality, and trade barriers to the import of foodstuffs continue to exist, in terms of international competition, the situation will clearly get worse for developing countries. This is principally because of product substitution, and by the increasing ability of industrialised countries to produce enough foodstuffs to become self-sufficient. Products such as sugar, shikonin, coffee, cocoa, vanilla, and cotton, are just some potential cases. Agricultural producers already have very difficult times, especially with protectionism. If trade barriers were removed, the future would be brighter for developing countries if they could produce cheaper foodstuffs, industrial raw materials and products in transgenic plants and animals, and especially so if the storage life of foods was increased so that it did not spoil during transport.

The situation in terms of food production and life quality in developing countries, may improve nevertheless, because developing countries will become more self-sufficient and have better quality foodstuffs, and increased energy production from biomass. For example, if a pest resistance gene saved 1% of total rice crop in India from disease, it would save US$300 million a year (5). However, self-sustainability for most developing countries is several decades away.

As countries become more self-sufficient international trade may be less important. If developing countries still import high-technology products, they would become even more indebted, and the whole international system of trade would be threatened. It would also create more political instability, because as the hopelessness of repayment was more evident, countries would exit from the system. It is obvious, that a potential collapse of the economic system may persuade industrialised countries to attempt to reduce their trade surpluses, or aid the debtor countries so that they continue in the system. It is impossible to predict the outcome. We can hope that trade barriers and protectionism are reduced, but inside most countries the protection of small rural farmers is considered socially important; and one must balance the questions of international trade versus national socio-economic structure. Biotechnology could aid the survival of farmers, if more disease-resistant and climate tolerant varieties are introduced. The production of biomass as renewable energy, and industrial and pharmaceutical products in crops and livestock, will provide additional need for agricultural production. However, multinational petrochemical and pharmaceutical companies may control the seed needed for such crops, and they could produce hybrid seed rather than open-pollinated varieties so as to maintain their control and steady profits. If fees need to be paid for seed, larger farms may succeed more than smaller farms. It is questionable whether biotechnology will support the survival of traditional village structures, and small land holders. A free market approach would not do this, unless there were strong incentives and disincentives established.

Privatisation of Biotechnology

Biotechnology is almost by definition, applied research rather than basic research. However, the continued development of biotechnology does require much further basic research. The biological features, and even existence of many organisms, remain unknown. The ecological characteristics of most organisms in the world, especially in the developing world, remain unknown. We need to know the ecology of organisms that we may introduce to new environments (6) and the ecology of new varieties of organism, however they are made. We also need to identify possible genes associated with useful features, that may be applied in biotechnology.

Because of limited research funds, much of the research in developing countries and small industrialised countries is applied research. Applied research is targeted for specific goals, such as the production of particular disease resistant crops, or specific vaccines. Research facilities include Universities, government and private Research Institutes, and hospitals. The funding in most industrialised countries is from industry and government, but in developing and smaller countries, a lack of industry means that government funding is even more essential. We should all contribute to shared knowledge that people can benefit from, therefore research funding should be shared between countries. Many people believe that the pursuit of knowledge itself is a good, though increasingly the pursuit of beneficial knowledge is viewed as more important. To perform research has a positive effect on the teaching standard at Universities, which may be a more significant benefit in small countries than the direct results of research. Another important, but perhaps less worthy, argument people give to promote research is that of national pride. This can be converted to political benefit, if countries are seen to provide much international development assistance.

Research has for many decades also been viewed in terms of the business opportunities, both internationally and within nations (7). As national budgets become more stretched with other needs, many are encouraging more research by industry, either by industry cooperation with government researchers, or independent facilities. If research was performed in publically-funded laboratories, and was published freely, there may be less problem with international technology transfer. National governments may transfer technology to other countries as part of development aid. Nonprofit private organisations are also very important in biomedical research in some countries, and they usually allow export of technology. For example, the world's largest gene-mapping laboratory in France, the Genethon (8), funded by charity, has used automatic DNA sequencing to map the human genome. However, much of the new wave in biotechnology research is being performed by private companies. These companies are being encouraged to perform research in those countries' national interests, including the hope of more export earnings from the sale of products and/or technology.

It is obvious that the goals of private companies are not those of whole countries. Many Western biotechnology companies are of very small size, but multinational corporations have been gaining increasing control of biotechnology research. There have even been some takeovers of large biotechnology companies, for example the takeover of Genentech by Hoffman Roche, and the selling of Cetus's PCR technology to Du Pont. Also, many large companies, such as Monsanto in the USA, realised the commercial potential early on and so invested considerable research money into biotechnology. In Japan, government ministries and large multinationals have been the major investors in biotechnology from the early 1980s, because of more difficulty in establishing small companies than in the USA. Governments may like to view the competition as between countries, but it may be more like that between multinational companies.

In some developing countries there has also been major investment in biotechnology, and there is research on numerous applications in China and India. However, there is still a lack of research facilities, qualified personnel, and funding sources to exploit biotechnology. Strategies used depend on the size of the country, small countries can still apply international cooperation agreements to local needs if they lack sufficient resources themselves. No single policy is best (9).

Large multinational companies may also make development agreements with developing countries. In 1991, the company Merck & Co., made an agreement with Costa Rica, to exclusive rights to new potential "products" it finds in an area of its tropical forests until the year 2,000 (10). It is like a hunting license for useful compounds. If successful, a share of the profits will be paid to Costa Rica (11). This also should encourage other countries to preserve large areas of their forests. It is important to encourage in situ conservation, and if no other group will put up the finance than it will be left to large companies who will benefit from the new substances found. This is not such a new phenomenon, industrialised countries have been gathering seeds and genetic resources from other countries for centuries, for the development of new crops and products. In June 1992, at the World Environment and Development Conference in Rio de Janeiro, Brazil, a Biodiversity Treaty was signed, which has important implications for the protection of biodiversity by all countries, and may preserve the intellectual property rights of products derived from the diverse species. However, the USA did not sign this treaty, and it also is too early to say what impact the Biodiversity Treaty will have on industrial investment in biotechnology and technology transfer - though it will have a good longterm effect in the preservation of biodiversity in many countries.

Patenting of Biotechnology Discoveries

Many new discoveries are being patented, both research performed in national and private laboratories. The normal criteria applied to determine whether a patent should be issued are that the invention has the attributes of novelty, non-obviousness, and utility, and the invention should be deposited in a recognised depository. There is some debate about whether living organisms should be patented, and this is discussed in the following section. First let us consider some general questions concerning the question of patenting.

To qualify for a patent an invention must be novel, non-obvious and useful. If the claimed invention is the next, most logical step which is clear to workers in that field, than it cannot be inventive in the patent sense (12). In the case of natural products many groups may have published progressive details of a molecule or sequence, so it may have lost its novelty and nonobviousness. Patents are granted on molecules which have medical uses, if the chemical structure, or the useful activity, was novel when the patent was applied for.

Patenting rewards innovation, but the mere sequence of genetic material may not be innovative, even if the technique used is. There are patents on short oligonucleotide probes used in genetic screening. If someone can demonstrate a use for a larger piece of DNA than they can theoretically obtain a patent on it. An example of a larger patentable section of genetic material would be a series of genetic markers spread at convenient locations along a chromosome. Another set of genetic markers on the same chromosome can be separately patented if they also meet those criteria. To sequence genetic material is not what we normally call an invention. The sequencers of DNA are not sequencing un-owned land but rather they are sequencing un-characterised land, the name of mappers is rather suitable for this analogy.

Methods for gene sequencing, or mapping, or expression, can be invented and patented. Biotechnology process patents can be viewed in a similar way to existing process patents. The information may be used in the study of a particular disease, for example, by the introduction of a gene into an animal to make a model of a particular human disease. The process for making "Oncomouse", a mouse that contains activated oncogene sequences that is therefore sensitive to carcinogens, was patented, and it was the first mammal to be patented, in 1988 in the USA. The genetic information can also be used to cure a disease, for example using the technique of gene therapy with a specific gene vector. The direct use of proteins as therapy is well established, and these products may be patented, though we should note, in general, medical procedures have not been patented for ethical and practical reasons.

With the completion of the genome sequence of many organisms, including humans, any new genetic material will no longer be novel as it will be available in a database. In late 1994 a database of human gene sequences was made available for researchers from The Institute for Genomic Research (TIGR), which contains over half of the estimated 70,000 human gene sequences in 150,000 cDNA sequences (13). Users must sign an option agreement, and companies will have 6 months to try to make joint shares in commercial developments. The release of the cDNA sequences from TIGR to the general community is under the condition that TIGR can take first look for 30 days before publication at papers, with an option for a 30 day extra delay.

The completion of the genome maps and sequences of many organisms will have many implications for the future of biotechnology patents. However, it may be cheaper to buy some genes off companies or to use specialist companies to perform specific gene splicing experiments, rather than the experimenter doing every step themself. Although developing countries have a shortage of research money, the potential for speedier applicable technology when the researchers can concentrate on the special aspects of a project rather than on the more mundane aspects of constructing genetic maps or gene vectors, may eventually convince some governments that this is a better use of research money for some projects. This could also stimulate the biotechnology industry in developing countries. If a new technology saves enough money, for example reduced crop losses, or environmental degradation, than introducing it several years earlier is worth the investment.

A patented product that reaches the commercial market gives the inventor some compensation for the time they spent in research for the development. In the USA the average time required for biotechnology medicines to be approved for commercial sale by the Food and Drug Administration is 21.4 months (14), after results of clinical tests, and it could be ten years after identifying the substance. The period of patent protection varies widely between countries, but in Europe, USA and Japan it has recently been standardised to provide protection for about 15 years after product approval (15). Once a product is licensed, the sales can bring about much income for the companies that produce them, and this includes returns for the "inventors". The 1991 world market for drugs and medical products made by genetic engineering is about US$3 billion, and by the year 2000, it is expected to be US$30 billion. The system is self-sustaining, if patents are awarded, companies will invest time into research, but if not, there is less incentive for companies to conduct research and less total research. Some processes can be kept industrial secrets, but it can be difficult. It may be easy for other companies to copy the techniques soon after introduction, and take a share of the commercial market, especially because they do not need to pay for the long period of research for product development. Some system of reward is required to encourage commercial research, which is responsible for a significant number of biotechnology applications. The international recognition of intellectual property rights (patents and variety rights) is thus a basic concern.

We can apply the ethical principle of beneficence. Does commercialisation of biotechnology lead to more benefits than a ban? The benefits should be in terms of general medical or agricultural development, rather than economic prosperity of one company or country over another. Patenting promises useful consequences (e.g. new products/research). If patenting is not permitted useful information will become trade secrets, or if plant variety rights are not recognised seeds may not be transferred. There may be a greater amount of total knowledge. However, property rights are not absolutely protected in any society because of the principle of justice, for the sake of "public interest", "social need", and "public utility", societies can confiscate property.

People arguing for patenting claim that patent law regulates inventiveness, not commercial uses of inventions, however, there was recent controversy regarding the commercial monopoly held by the company which was able to patent AZT, the first HIV/AIDS treatment, which enabled it to obtain large profits while it held a monopoly (16). It also meant that the drug was too expensive for developing countries, as most pharmaceuticals are. There are numerous examples where such commercial monopolies obtained cannot be said to be in the best public good. Another argument is that other countries support patents, so our country needs to if the biotechnology industry is to compete; however, the reverse argument is also used to argue for exclusions, that some countries do not permit similar patents.

Ethical Concerns about Patenting of Living Organisms and Genetic Material

The question of patenting of live organisms and genetic material is a contentious issue (17). In the USA and many other countries, normal patentability criteria apply to any subject matter, that is, the invention requires the attributes of novelty, non-obviousness, and utility, and the invention should be deposited in a recognised depository (18). While accepting these criteria, some countries have specifically excluded certain types of invention, for example the European Patent Convention excludes the patenting of varieties of plants or animals. However, in October 1991, the European Patent Office reversed its earlier decision and announced that it intended to grant a patent for "Oncomouse", and transgenic animals containing an activated oncogene (19). This decision will continue to be debated, and it is not certain what the outcome will be. There is public rejection of the idea of patenting animals in some countries, and Denmark excludes animal patents in a law.

In 1961 the Convention on the International Union for the protection of New Varieties of Plants (UPOV Convention) established international "plant variety rights", and by 1989 there were 19 member countries, which include more than 70% of the world seed market of all countries with a market economy. The requirements include stability, homogeneity, novelty, and distinctiveness. The varieties must be generally distributed and researchers have exemptions, as do farmers from the payment of royalties on seed that they save from their harvest. A few developing countries have national plant variety rights schemes, but have not joined UPOV. However, still no reward is given to the farmers who for millenia have established crop varieties, which plant breeders use as starting materials, so that Farmer's Breeding Rights have also been talked of (20). In 1982, the OECD estimated that the contribution of developing countries to the major crops in the USA was several billion dollars annually. In 1983, at a UN Food and Agriculture Organisation conference, representatives from 156 countries recognised that "plant resources were part of the common heritage of mankind and should be respected without any restriction" (21). Since then an international network of genebanks has been established, who will provide genetic material worldwide (22).

The public attitudes to the patenting of different types of subject matter has been measured in New Zealand in mid 1990 (23), and in Japan in 1991 (24). People were asked if they agreed whether patents should be obtainable for different subject matter. The results for different groups of the population are illustrated in Table 13-2. There was less acceptance of patenting new plant or animal varieties than of inventions in general. Only 51% of the public agreed with patenting of "genetic material extracted from plants and animals" in New Zealand, and only 38% in Japan. There was even lower acceptance of patenting "genetic material extracted from humans", in Japan only 29% agreed. There was more acceptance of the patenting of genetic material among those who thought there were benefits to their countries from genetic engineering, and by farmers, and by scientists in Japan. There was less acceptance of patenting among the age group 15-24 years old and among high school biology teachers in New Zealand.

An International Bioethics Survey with 150 questions including 35 open ones was developed to look at how people think about diseases, life, nature, and selected issues of science and technology, biotechnology, genetic engineering, and medical genetics. The mail response survey was conducted in 1993 among the public in Australia (N=201), India (N=568), Israel (N=50), Japan (N=352), New Zealand (N=329), Russia (N=466), and Thailand (N=680), and the same written survey was conducted among university students in Australia (N=110), Hong Kong (N=105), India (N=325), Japan (N=435), New Zealand (N=96), The Philippines (N=1164), Singapore (N=250) and Thailand (N=232) (25). The question on approval of patenting from the 1991 survey in Japan was included. In all samples there was least acceptance of patenting human genetic material.

Arguments against patenting life include metaphysical concerns about promoting a materialistic conception of life. We may begin to view animals the same as we do material goods. Living organisms, and their genetic material, are special and should be considered different to other "materials". Patenting produces excessive burdens on farmers and on medicines (increased costs to consumers, payment of royalties for succeeding generations), and increased burdens on the developing countries. Some of these issues may not be directly affected by permitting patents, rather they are issues such as the distribution of wealth, or international competitiveness (26).

Some critics of ownership could go as far as to call those who seek to profit and to control genetic sequencing, "genomic imperialists" (27). In 1991 and 1992, patent applications for nearly 3,000 human genes based on randomly-sequenced cDNAs were made by the National Institutes of Health in the USA. These raised major questions about patenting policy because researchers are reluctant to share genetic sequence data in databases while there is the possibility of others abusing it, and when the NIH and MRC have withheld their data from entry into gene databases while preparing patent applications (28). It would have grave implications for open data-exchange if such patents were upheld. A further application for a patent on one thousand human genes by the British Medical Research Council followed (29). However, there is no demonstrated utility, and using automated DNA sequencers is not very innovative technology, it is obvious to any researcher with the resources to allow them to use them, so in addition to ethical or policy issues, they may fail on these grounds. These government bodies may sublicence particular national companies to pursue research on these genes in an attempt to "protect" their national biotechnology industry. Actually, the publication of such sequence markers will make it more difficult for companies to patent those genes and could discourage research, because such genes will no longer be novel, however the whole policy related to this area is undecided. Public opinion (Table 13-2) could force a policy change regarding the patenting of genetic material, even if it is judged to be legally valid, but it should be made considering all the economic, ethical and social implications. In the UK, "patents shall not be granted for an invention, the publication or exploitation of which would be generally expected to encourage offensive, immoral, or anti-social behaviour". Similar exclusions are common to European and US patent laws. It is an area of much debate, and France and Japan have said that they will not seek such patents, and Britain has said it is opposed to them (30), despite the MRC application.

Table 13-2: Public Opinion over Patenting

Results from surveys conducted in New Zealand (NZ) in 1990 (22) and in Japan in 1991 (23).

Occupation of Respondents:
Public
Scientists
High School

Biology Teachers
Farmers
Country
NZ
Japan
NZ
Japan
NZ
Japan
NZ
Sample number
2034
470
258
479
277
227
200
Subject matter: Results expressed as % of total supporting patents for
New Inventions
93
91
95
94
88
92
94
Books, information
85
73
81
82
72
77
81
New Plant Varieties
71
60
66
78
49
61
66
New Animal Varieties
59
49
63
74
51
60
63
Genetic material from

plants/animals

51
37
53
46
34
38
53
Genetic material from

humans

-
29
-
35
-
29
-



Sharing the benefits from biotechnology - technology transfer

There are major applications and implications of biotechnology. Some of these are presented in Table 13-1. All people should share in the benefits of biotechnology. There are religious backings for this, such as "love thy neighbour as thyself", the utilitarian ideal that we should try to benefit as many people as possible, and from the ethical/legal principle of justice. In the United Nations Declaration of Human Rights, Article 27(1), is a basic commitment that many countries in the world have agreed to observe (in their regional versions of this declaration). These are (1) Everyone has the right freely to participate in the cultural life of the community, to enjoy the arts and to share in scientific advancement and its benefits.(italics added for emphasis) (31). The common claims to share in the benefits of technology should be considered in all aspects of biotechnology, also including the questions of who should make decisions concerning its applications (32).

Table 13-1: Probable Effects of Biotechnology and International Trade of Biotechnology Products and Services on Developing Countries

Positive EffectNegative Effect
* Increase crop production, more food

- Extension of growing area with drought and salt tolerant crops, may increase labour

- Disease and pest resistance

* Increase livestock health, and production

* Increase nutritional qualities

* Increase storage life of foodstuffs, especially useful for the poor who lack good transport and storage facilities

* Decrease dependence on imported fertilisers and chemicals (except herbicides)

* Increase public health, via cheaper multiple disease vaccines, and genetic diagnostic kits

* Faster growing trees, for biomass production, as an energy replacement

* Biodiversity may be preserved, as international companies buy exploitation rights in return for conservation

* Possibility of new products from increased research into genetic resources, and from the use of animals or plants as bioreactors

* Tissue culture allows continuous production, and more reliable product quality

* Loss of export markets as products are substituted by production of alternatives in industrialised countries. Loss of foreign income and employment

* More cash crops may be grown, to produce high value commodities, less food crops

* Strengthen large agricultural estates, and displace small-scale landholders and farmers

* Reduced labour needed for cultivation

* Herbicide-tolerant plants may reduce labour market in weeding, also may increase dependence on foreign imports of chemicals

* Privatisation may increase the portion of seeds that require fees for use, and local farmers may lose control of seed Co-ops

* Greater privatisation, increases both legal and financial barriers to use of varieties

* Biodiversity may be reduced as more efficient monocrop systems are introduced, and larger size farms are used

* Loss of natural ecosystems in marginal lands, as new crops are introduced to those areas



Over 100 countries allow some form of patent protection, but developing countries often include exclusions for pharmaceuticals and agricultural inputs. Because it is easy to copy production procedures, those countries may reproduce products without paying licensing fees. As a result, technology transfer to countries without patent protection is slow (32).

A special case is that of the human genome project's results. All people share this sequence, and thus could be called shared owners of it. Recently, efforts to collect DNA samples from all the world's human populations has commenced, to create a general cell bank (33). It has been argued that the human genome, being common to all people, has shared ownership, is a shared asset, and therefore the maps and sequence should be open to all (34). Growing numbers of disease causing and disease-susceptibility genes are being sequenced and the mutations characterised. It will be possible to develop DNA probes to diagnose most genetic disorders. It will expand the number of human proteins that can be made by genetically modified organisms (GMOs), which would allow conventional symptomatic therapy for many more diseases, which could be supplemented by somatic cell gene therapy when appropriate. DNA probes have also been used to speed up diagnosis of infectious diseases. It would also expand our basic knowledge of human biology, which allows medical treatments to be developed. It is obvious that within the next few decades medicine will undergo a major change in all countries, this is the beneficial side of the extra knowledge. People in developing countries will indirectly benefit from all the technology developed, which will also be used for the sequencing and manipulation of genes in all other living organisms.

Technology transfer can be associated with bad consequences if diversity and innovation are reduced. Over human history about 3,000 plant species have been used for food, but this number has decreased so that there are only about 20 principle food crops used now (35). This is partly because of external conquest and domination which tends to suppress use of local food crops. Plant breeding used for modern agriculture, including the "Green Revolution", has reduced the number of varieties to those which are the most productive, at the cost of genetic diversity. It is important to maintain genetic diversity, and crops that may be used in one country do not mean they are the best crop for use in another, also the yields obtained in experimental plots may be much better than in the farmer's field, due to the different local environment. In a 1991 report the use of microlivestock for animal food production was recommended for developing countries (36). Smaller and more efficient animals could be used for meat production in developing countries. It would certainly be an advantage to have small animals for food in some countries, you would also avoids the need for some food storage. It would maintain genetic diversity. However, in times of food shortage, plants would seem to be more efficient at producing protein.

Another important point is the use of intensive agriculture, with chemical fertilisers and pesticides, and multi-application procedures. Although they should be used when, considering environmental effects, they are more efficient, efforts should be made to switch to crop and animal systems less dependent upon intervention. Companies in industrialised countries are continuing much research on applications of biotechnology that require such inputs. An example is the development of herbicide-tolerant plants, where both seed and herbicide are controlled by the same companies, though they should have environmental advantages when substituted for systems using non-biodegradable herbicides. There should also be attempts to use biological pest control, and genetic engineering to insert genes directly into openly pollinated crops, which can be used by farmers in developing countries without dependence upon seed and chemical companies (which are often controlled by the same multinationals) (37). The question is who decides what varieties should be grown in developing countries, and whether it is for local or "international" needs.

Within developing countries, applications should attempt to preserve rural structure, so that villages could create small-scale biotechnology "factory" supplies to earn income. In developing countries, the agricultural sector employs over 80% of the active population, but in industrialised countries only 5-10%. Some crops are labour intensive, and others are not, for example, oil palm plantations require about one third of the labour required in banana plantations. Production of new products, such as single cell protein may reduce labour. Weeding is one of the most labour intensive operations, but it will be reduced as herbicide tolerant crops are introduced, this will lead to loss of work for many people, especially women (38). However, year round crop production may increase labour. The effects depend on the country, for example the use of bovine somatotropin (BST) to increase milk production in dairy cows is being opposed by many groups in Western countries because it may favour larger farms (39), but in some developing countries, such as Mexico or Pakistan, its use would be welcomed because it may reduce imports of milk powder.

Some companies have said that they will export technology to developing countries if they do not expect to profit from the sale of such procedures in such countries, free of charge. This is to be encouraged. Even if such technology is not transferred, the use of genetic engineering techniques including the DNA polymerase chain reaction allow very simple copying of genes from one organism to another. For example, although it could be called piracy, it would be easy to copy a Bacillus thurengiensis pest resistance gene and its regulatory elements from a transgenic plant, and to construct a vector to insert it into another plant. Some companies have said that they will insert specific marker nucleotide sequence changes to monitor any piracy, but it would be very unlikely that they would sue for damage from a developing country. Therefore, it may be better for such companies to give away new varieties to developing countries, and they will receive public support for such action in the industrialised countries, without losing any profits because the developing countries may not have been able to buy the new varieties anyway. However, we should remember that only varieties of commercial value in industrialised countries will be developed by private companies, so that researchers in developing countries still need to develop local varieties.

Changes to International Trade and Future Economic Systems

Biotechnology will improve the efficiency of agriculture. This will aid the feeding of the populations of every country, but as discussed, it may not necessarily mean improved trade. The increased efficiency of agriculture will make many countries self sufficient in food production. This will mean that agricultural exporters may find difficulty in selling produce, and also the food prices may be lowered, thus they will lose foreign earnings. The nutritional quality of food is also being improved by genetically engineering, for example to match the amino acid balance in foodstuffs with human or animal dietary requirements. Only if countries diversify to new markets and products will they be able to continue to rely on agricultural production. This will make it very difficult for such countries to compete in the international economic markets, and one result could be that such countries will increasingly find themselves in debt to countries that export industrial products. In the medium term, developing countries could switch to quality products such as specific fibre products, or high quality foodstuffs, but in the longterm the solution may be to switch to the production of high value substances via agriculture. Products such as pharmaceuticals or therapeutic proteins could be produced in plants and animals, and exported. However, the research for genetic manipulation of plants and animals to produce such products is concentrated in industrialised countries, and in many cases small farms could provide national needs for such compounds. Products for the food industry, such as new sweeteners and oils could be made in plants, which would require larger areas of crops. The concern must be, whether these crops can be grown in addition to local food crops.

Biotechnology is sure to continue to change the international trade situation. A benefit for some developing countries may be the development of fast growing biomass, that could be used as a fuel source to reduce the need for oil imports. In addition to the obvious environmental benefits (40), it would also lessen dependence on imported oil and gas as a source of energy.

We must question the future goals of societies. What is the meaning of life, and is increasing use of technology associated with an increased quality of human life, both as individuals and as a society? If we question this, we may also question the future of international competition in trade. The term competition itself implies that there are winners and losers, and the losers are usually developing countries. If we eliminate competition, than we may allow more global responsibility.

Modern capitalist economics appears to be very successful at increasing the wealth of nations and the general living standards of people in them. However, despite the advantages of market economies, we must really ask whether such commercial competition is in the interests of developing countries. We must also look at the implications for developing countries. We have seen the acceptance by some countries that the current economic system is not sustainable because it does not value the environment, and there is debate over how to change the economic system. For all countries, long term sustainable economic policies are required, different to today's. Genetic resources have been connected with economic prosperity throughout history, so the fact that many developing countries do possess such resources is an advantage, they must attempt to minimise the loss of control over them, and preserve them. The presence of biological diversity is a great long term economic asset, more important than the short-sighted policies which destroy them.

The Ethical and Social Impact of Biotechnology

We can say that all people should benefit, but we must ask whether they will? The new technology presents both benefits and risks. Scientific risks can be controlled more easily than the risks of unethical applications and bad effects on societies. We have considered moral responsibility in general questions of biotechnology transfer and use, it is also important to summarise some of the principles that should be used to ensure more ethical uses of biotechnology directly affecting people as individuals and in society.

The 1990's are the time of a paradigm shift, for scientists to give support, in terms of time and money, to consideration of the social impact of their research. This is already underway in Europe, also in North America, and it is beginning in Japan. One of the stimuli for this consideration of bioethics, were the Human Genome Project's in these countries. Scientists now refer to ethical, social and legal impact (ELSI) issues of research (41). A trend for scientists to give some financial support to ELSI research was initiated in Europe and the USA. In 1992 5.2% of the Human Genome Project grants from the NIH in the USA were for ELSI research. In the USA in 1992, a total of US$9 million is being spent on research on the social impact of biotechnology. The European Community has also supported many ELSI projects, and the Canadian genome project is allocating at least 7.5% of its funding to ELSI issues. We can hope that the funding of ELSI research in other countries, such as Japan, and developing countries will increase, as these ELSI grants are one measure of the seriousness that molecular biologists and geneticists place on looking at the social impact of their research. Another measure is their growing willingness to participate in multidisciplinary seminars, and the extent to which they start to interact with the general public. To become involved in genuine consideration of ELSI issues requires commitment of time and resources. We need to broaden the understanding across disciplines that have traditionally been closed, and growing consideration must be given to ELSI issues, issues which are not always new, but will become ever more important in the new age of the genetic information explosion. All countries will be affected, and there needs to be research on ELSI issues by people in all societies, as although the science may be similar, the societies and social and ethical attitudes can vary.

A recent survey of attitudes to biotechnology and genetic engineering in Japan was compared to surveys in New Zealand, USA, Europe and other countries, in an attempt to obtain some data on how people think (42). The most common response in both countries for a benefit from genetic manipulation of human cells were medical reasons, as from microbes where the benefit of making useful substances was also often cited. Economic benefits were not cited much, with more respondents in New Zealand listing these benefits, perhaps because the economy is so dependent upon biotechnology, in terms of agriculture, and the economic recession has been much harder there. In the reasons cited for genetic manipulation of animals, many more New Zealanders cited disease control of animals, as a reason. In both countries similar proportions cited "new varieties" or "increased production and food" as the main benefits of genetic manipulation of plants and animals, with a trend for more New Zealanders to cite the later.

The major reasons cited for the unacceptability of genetic manipulation can be grouped into categories:

1. Unnatural, playing God, unethical, feeling

2. Disaster, fear of unknown, ecological and environmental effects

3. Human misuse, insufficient controls, eugenics, cloning, humanity changed

4. Health effects, mutations

5. Reason not stated.

Group 1 concerns may persist with development of the technology, but group 2 and 4 concerns may be lessened by development of technology. Group 3 concerns can be lessened by regulations. People who did not cite a reason may feel less strongly about the issue, but there is no real indication of what concerns they had. We should also note that many people expressed reasoning across several of these types of concern.

There was also a wide diversity of responses to the reasons why people perceived risks from genetic manipulation. The risks were in general more involving human misuse, and activity, rather than abstract concerns such as "interfering with nature". They were also more specific, so that more respondents listed deformities and mutations as a problem. In addition to ecological and environmental concerns, there was also substantial numbers who cited a risk connected with the spread of genes, viruses, and GMOs, what we could call "biohazard". A few said that science was always associated with danger. It found that there was significant similarity in the reasoning of people in Japan and New Zealand, but there is an absence of data from other countries. In the International Bioethics Survey open questions on the benefits and risks of genetic engineering and biotechnology were included, and many interesting comments were written. The reasons expressed were consistent with the 1991 results, and suggest that similar balancing of benefits and risks occurs in other Asian and Pacific countries (43). Research in all countries, including developing countries, needs to begin to allow society to better prepare for the impact of biotechnology.

The possibility of control over the human DNA, which is already possible to a limited degree in applications of genetic screening and gene therapy, raises the issue of genetic selection and eugenics. New technologies, such as somatic cell gene therapy have entered clinical trials in many countries, for a wide-range of diseases and purposes (44). People in all countries of the International Bioethics Survey strongly supported human gene therapy, even more strongly than in the USA, though they may still have some concerns about it (45). We need to elevate the importance of individual autonomy, especially in reproduction, while at the same time limiting misuse of new technologies by individuals, for example for enhancement genetic engineering. We need to maintain a distinction between diagnosis and treatment of disease, and selection for desirability. Some countries allow the use of sex selection itself, and in most countries it is condemned but not illegal. With the application of genetic screening we can ask whether the next generation will benefit from being genetically selected? We need data to measure the effects on personal, family and social attitudes. There must be limits on reproductive choice for enhancement, though guaranteeing reproductive freedom is a much more urgent ethical problem in some developing countries.

Universal laws, for example Article 23 of the International Covenant on Civil and Political Rights (46), states that "the right of men and women of marriageable age to marry and found a family shall be recognised", that has been signed by over 75 countries, and should guarantee that compulsory eugenics is not introduced. It is a very strong statement based on the ethical principle of respect for human autonomy. While we should not be afraid for society to change, we should be very cautious about possible adverse social attitude changes, because social pressures are very difficult to control. Such a law needs to be supported by equal access to social and health services in order to make it effective. In the same covenant there is also supposed recognition of equal access to health care, but what is required is "equal access to equal health care".

Genetic screening for many disease traits and susceptibility to disease will be able to be performed, confidentiality is important so that individuals that are found to be carriers of alleles for genetic disease are not discriminated against. The question of fairness in the use of genetic information with respect to insurance, employment, criminal law, adoptions, the educational system and other areas must be addressed (47). Education and laws to ensure that equality is respected are required. We must also attempt to avoid stigmatisation or ostracism, and labelling in general. We must look at the possible individual psychological responses. There will be a change in attitudes to ourselves and social customs, and genetic determinism might become popular. This oversimplifies the complex interaction of genetics and environment. In the extreme, determinism eliminates the idea of genuine choice, leaving no room for the belief that we can create, or modify ourselves, or that we can make moral choices.

Most religious approaches support the rationale for obtaining better genetic information, which can be used for human benefit or to alleviate human suffering. It is essential for widespread education to be available in a way that the public can understand it, and they can be involved in decisions that will change the shape of the world. An adequately prepared lay community is the best way to ensure that misuse of genetics does not reoccur. Also, the amount of information obtained will overwhelm existing genetics services in industrialised countries, and geneticists. The delay in the introduction of widespread genetic testing in developing countries because of personnel and resource shortages may allow selection of the most appropriate technology, ethically, socially and scientifically, from the possible misfortunes of the industrialised countries!

A common feature of many issues raised by biotechnology is that we need to consider the effects of knowledge and technology on future generations, from the principle of justice. Our traditional view of morality only involves short term consequences. The ability to genetically engineer all organisms including ourselves changes our moral horizon, as do changes already underway to the global environment (48). We need to ensure future generations retain the same power over their destiny as we do, while benefiting from the culture and technology we have developed.

Ethical Criteria for Biotechnology

There is a moral imperative to obtain predictive knowledge and data about the wide-ranging possibilities of any action. Secondary consequences may be sufficient to prevent the primary action, even when the primary action may be good. This imposes a restraint on the use of technology. Researchers may be held accountable for secondary consequences of their research.

We also can ask what criteria are important for scientists to follow to ensure that we have ethical biotechnology. Although it is possible to develop useful numerical scoring systems, as has been attempted for animal experiments (49), they are still only guides and may be more useful in directing attention to the better and more ethical design of experiments. Therefore only some criteria important to assess the ethicity of an experiment or application are given below:

1. What is the benefit? To whom? Is it life-saving? Human benefit is greater than monetary benefit.

2. Do no harm to humans. What is an acceptable level of risk? Follow ethical codes on free and informed consent for human experimentation.

3. Do not cause pain. Protect animal rights as much as possible, use less sentient animals for research, and develop non-animal alternatives.

4. Do no harm to the environment. Use the technology that is most environmentally sustainable over the long-term. Minimise consumption, may need to introduce environmental quotas to do this according to just distribution of global assets and introduce maximum levels for individual production of pollution.

5. Protect biodiversity. Protect endangered species. Allow farmers affordable or free access to breeding stock, and encourage planting of diverse crops.

6. Justice to all people, and future generations. Share benefits and risks.

7. Independent open decision-making on safety questions, consider ethical and social impact.

8. Inform and educate the public and scientists about all dimensions of the projects, scientific, social, economic and ethical, using third party media.

International cooperation

It would be unethical to withhold information that could save human lives or environmental harm, therefore international cooperation is required, competition should not sacrifice lives. One thing that should have been learnt by people in industrialised countries is that the number of middle class people can increase in society, and this lesson should be applied to the global situation. The improvement in living standard of people in one country is not a threat to the lives of people in other countries, rather it is respecting equal human rights and justice, which many people claim to recognise. New varieties of crops and animals should be available to all at an affordable price, and without discrimination.

The legal representatives of the people of the world, and the representatives of the various viewpoints of people's of the world (these may be different) need to join together to make decisions. Currently, it has been assumed that who pays for the research can control the direction of biotechnology, but genetic resources are the shared property of all. Technologies of important international interest and utility should be openly and equally accessible to all people in need.

We must also look at the role that individual scientists can and should play in the world. Despite the large commercial pressures, there is still much scope for scientists to allow the introduction of biotechnology to developing countries. In the modern world scientists cannot bury their heads in the sand, or in their individual research, or in the interests of their individual companies and countries. Different countries face different situations, but all can apply biotechnology. In sub-Saharan Africa, especially, the limiting factor is the shortage of trained scientists in biotechnology, in addition to shortage of funds. However, comparatively small investment is required in biotechnology for potentially large returns. International aid organisations would be well advised to also consider this. There are some recent cases of the free introduction of technology from companies who had obtained biological materials from developing countries, which is to be commended. However, much more is required. Public opinion in industrialised countries can influence the "generosity" of multinational companies, and more pressure could be exerted by all people's of the world to achieve greater cooperation.

The international nature of biotechnological research and its universally applicable results mean that it is essential to have international organisations such as UN bodies taking an active part in the scientific work and considerations of the ethical, legal and social issues of both human genetics (50), and of agricultural uses of biotechnology (51). Not only those varieties and organisms desired by companies in industrialised countries should be used. Many countries are unable to significantly contribute material resources to the scientific advancement of biotechnology, but they share in the human relationship to the biosphere, the organisms whose genes are being used are often present in many countries, and many have been taken from developing countries. Society's interests should transcend proprietary rights, especially given the special nature of living organisms. Humanity does have a chance to build on the supposedly improved international climate in very practical ways.


<B>References</B>

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