Darryl R. J. Macer, Ph.D. Eubios Ethics Institute 1992
Much of the new wave in biotechnology research is being performed by private companies. These companies are being encouraged to perform research in their countries' national interests, including the hope of more export earnings from the sale of products and/or technology.
Biotechnology is almost by definition, applied research rather than basic research. Such research is targeted for specific goals, such as the production of particular disease resistant crops, or specific vaccines. However, the continued development of biotechnology does require much further basic research. The biological features, and even existence of many organisms, remain unknown. We need to know the ecology of organisms that we may introduce to new environments and the ecology of new varieties of organism, and the ecological effects of agricultural chemicals and alternative farming practices, as discussed in chapter 4. We also need to identify possible genes associated with useful features, that may be applied in biotechnology.
Research facilities include universities, government and private research institutes, and hospitals. The funding sources in different countries come from government, charity or industry. In Japan, funding is principally from industry, whereas in New Zealand, research funding is principally from the government, using tax revenues. In Japan approximately 19% of scientific research and development funding is from the government, whereas the proportions for some other countries are: Australia (50%), England (37%), France (48%), Germany (33%), Netherlands (42%), New Zealand (63%), USA (48%). In the USA about 7% of the total government spending is on research and development, but in Japan it is only about 3%, while Western European governments spend 4-5% of their budget on research and development (OECD 1991). In Japan, in the area of biotechnology there is more government investment. In 1990 the Japanese government agencies spent Y90 billion and industry spent Y200 billion (Karube 1990, Scheidegger 1991). Research has for many decades also been viewed in terms of the business opportunities, both internationally and within nations, especially so in Japan. Many people believe that the pursuit of knowledge itself is a good, though increasingly the pursuit of beneficial knowledge is viewed as more important. Another important argument people give to promote research is that of national economy and pride. This can be converted to political benefit, if countries are seen to provide much international development assistance.
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 may be about 1000 biotechnology companies in the USA, but many have difficulties because of the long period of research required before any profits are made (OTA 1991), and also many patent claims are contested in lengthy court battles with inconsistent rulings in different countries. The US biotechnology industry is valued at about US$4 billion and by the end of the decade may be valued at about US$50 billion. However, 1991 was the first year that the biotechnology industry as a whole showed a profit. Many biotechnology companies have been taken over by large multinationals. In Japan, government ministries and large multinationals have been the major investors in biotechnology from the early 1980's, because of more difficulty in establishing small companies than in the USA. Also, they have sufficient profits to invest in research. Internationally, there will be more competition between different multinational companies than countries.
In Japan people often claim that some field is behind the West, but the reverse argument is used in the West. In particular areas of biotechnology Japan is very strong, particularly the fermentation industry. Japan supplies about two thirds of the world's amino acid production and about 60% of the world's antibiotics. In agricultural and medical applications of genetic technology, Japan appears to be lagging the West, and the USA is considered to be leading the commercialisation of biotechnology (OTA 1991).
Economics versus Human and Environmental Benefit
This association of biotechnology with business, means that the primary goal is economic profit, rather than human or environmental benefit. This is not a new phenomenon, and internationally the public is becoming aware of this clash of priorities. In biotechnology we can expect benefits to humanity, but this is not the reason for industrial investment; the human and environmental benefits will come about as a secondary consequence. In the surveys of public opinion, and in this survey in Japan, many people said that the primary benefit of genetic manipulation will be to humanity, rather than economic benefits, as expressed in the answers to Q7c (see page 56, Table 4-6). 50-60% saw benefits to humanity and medicine, 5-8% saw benefits to the environment, whereas 5-7% listed national economy as a benefit, and 2-3% saw national living standards increasing. When asked about the risks of genetic manipulation, 1-3% said that they thought monetary gain may lead to safety standards being overlooked. But it is the responses to Q16c (see page 128, Table 8-1) that clearly show how company safety statements are not trusted by people, even by company scientists. Only 10% of the public said that they would usually believe a statement made by a company about the safety of a product it had released. Only 6% of government scientists would usually believe company safety statements, but 24% of company scientists said they would believe them, whereas 26% of government scientists, and 35% of company scientists, said they would believe safety statements by government scientists (see page 129, Table 8-2).
The Dentsu (1985) survey of the public in Tokyo and Osaka asked people what image they had of biotechnology companies, by their response to statements. 54% said they were enthusiastic about developing research, 33% said there were future prospects, 32% said it would lead to good technology, 28% said they could see the future well, 23% said they were active, 5% said the companies were rich so they could afford research, and 13% said they had no image. On the negative side, only 2% said they were approachable, 3% said they could trust them, 6% said that companies think about consumers. These results were interpreted to say that the public thinks that biotechnology companies have a good future. However, the answers to the negative image questions are more revealing about people's suspicion of companies. This may not mean special suspicion of biotechnology companies in particular, rather being true of companies in general, though in Japan most commercial biotechnology research is performed in major established companies.
Economics and the Environment
There are mixed effects of economic development on the environment, but generally they have been negative, through pollution and loss of biological diversity. Because consumption of products is the aim of business, and it always requires energy, and often resources, to produce products, economic activity will use energy and resources. The production of energy is associated with pollution, and also often with the consumption of resources. Therefore, as long as the energy for economic activity is associated with pollution, it will be in conflict with maintaining a stable environment. It is often short-sighted economics which destroys the environment, though many companies may also see profits in selling products to clean up the pollution they, or other companies, have made. In order to live, humans need to consume food, and some luxuries of life, but in the industrialised countries we all have excessive consumption.
Economic forces need to be directed to benefit the environment, which does not mean to increase consumption of products. In March 1989 people in five countries were asked their opinions about this issue. They were asked whether they thought that the development of the economy or the protection of the environment and nature should be the first priority, and the results are pictorially represented in Figure 5-1 (PMO 1989). People in Japan appear to value the environment more than in the four other industrialised countries surveyed. However, this does not mean that these opinions represent the situation in practice.
Biotechnology will have environmental benefits, and 5-8% of the public cited environmental benefits from genetic manipulation in Q7c (see page 56, Table 4-6). Many more agreed with Q16f (see page 78, Table 4-9). These include the use of renewable energy, such as the growing of fast-growing trees and plants (biomass). These plants can be burnt as a source of energy, or fermented to provide ethanol as a liquid fuel. These are worthy goals, but we should still endeavour to reduce energy use in addition to switching to renewable energy sources.
An example of an environmental problem is the use of intensive agriculture with multiple applications of chemical fertilisers and pesticides. Although they may need to be used in many countries to produce food, efforts should be made to switch to crop and animal systems less dependent upon intervention. However, companies in industrialised countries are continuing much research on applications of biotechnology that require such inputs because they are more profitable. Multiple application means farmers must continually buy products from a company, and the company receives constant income. A field of a herbicide-tolerant crop can be sprayed with the herbicide and only the weeds die. In the development of herbicide-tolerant plants by genetic engineering, both seed and herbicide are controlled by the same companies (BWG 1991). The use of these new herbicides and herbicide tolerant crops should have environmental advantages when substituted for systems using non-biodegradable herbicides, but there should also be attempts to use biological pest control. There should be genetic engineering in plant breeding to insert genes directly into openly pollinated and fertile crops, which can be used by farmers without dependence upon seed and chemical companies (which are often controlled by the same multinationals).
Another issue is the exchange of money for conservation. 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 2000. It is like a hunting license for useful compounds. If successful, a share of the profits will be paid to Costa Rica, while the company benefits 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 (Juma 1989). In 1982, the OECD estimated that the contribution of developing countries to just the major crops in the USA could be economically valued at several billion dollars annually.
Genetic resources have been connected with economic prosperity throughout history, so the fact that many developing countries do possess such resources is an advantage for them, but they should attempt to minimise the loss of control over them, and preserve them. There have been several gene banks constructed by the Ministry of Agriculture, Forestry and Fisheries (MAFF) and the STA in Japan since the mid-1980's. They realised the importance of genes as raw materials for biotechnology, and they were also concerned when the US gene banks changed their policy and had stricter controls on the free access to genetic material. Internationally, there is a network of gene banks, and some do provide free access to the materials stored.
Biotechnology will improve the efficiency of agriculture. 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. 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, and to the production of high value substances via agriculture. Products such as pharmaceuticals or therapeutic proteins can 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 meet 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. A concern must also be whether these crops can be grown in addition to local food crops in developing countries.
Within countries, applications should attempt to preserve rural structure. 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. What seems like a benefit, to reduce farm labour by using herbicide tolerant crops instead of weeding, will actually lead to loss of work for many people, especially women, and further poverty. Other traits will have benefit, such as pest-resistant plants which will not require pesticide application. Also year round crop production made possible by breeding climate resistant varieties, may increase labour, as the geographical areas into which such plants can be grown are extended. The effects depend on the country, for example the use of bovine growth hormone to increase milk production in dairy cows is being opposed by many groups in Western countries because it may favour larger farms, but in some developing countries, such as Mexico or Pakistan, its use would be welcomed because it may reduce imports of milk powder.
One recent example of biotechnology is the use of enzymes to convert corn starch into high fructose corn syrup for use as a sweetener, avoiding the need to import sugar. Japan and the USA are the world leaders in the production of high fructose syrup. This is estimated to cost the developing countries about US$10 billion annually in lost sales, in addition to great loss of labour need. This is called product substitution, and it will continue to reduce imports from the developing countries. Another, was the development of cell culture methods by Mitsui Petrochemical Industries to produce shikonin, which is used in cosmetics. It has meant that the producers, have lost their market. In 1984 Kanebo Pharmaceuticals released their "Bioseries" of lipsticks, which had high sales due to its positive association with biotechnology. People in industrialised countries may not be aware of the consequences of this. Biotechnology is sure to continue to change the international trade situation. The industrialised countries may reduce imports from developing countries, making the developing countries even poorer, so that the developing countries require more international aid. One could suspect, that the scheme behind this may be to increase the economic dependency of developing countries upon industrialised countries, increasing the political power of industrialised countries. However, it is a very dangerous path, because poverty often leads to war, and widespread war would be to the detriment of all.
Nevertheless, there are many definite benefits for all countries from biotechnology, and which should direct research attention to these ends. Most will be guaranteed a stable internal food supply. It is predicted that by the mid-1990's farms in the developing world will be commercially introducing new crops such as disease-resistant crops, made as a result of genetic engineering (Moffat 1992). 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, it would also lessen dependence on imported oil and gas as a source of energy.
This depends however, on whether the technology and varieties are exported to those countries. If research was performed in publicly-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. 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. The companies 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.
All people should share in the benefits of biotechnology. There is ethical and religious support for this, such as "love thy neighbour as thyself", and 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 U.N. 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, Sieghart 1985). 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). 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. This question is important for the sharing of technology, and also in the discussion about the ethical issues regarding life.
The question of patenting live organisms and genetic material is a contentious issue in many countries. In the USA and many other countries, normal criteria for accepting patents 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. In 1985 the US patent office awarded a patent for a maize variety, in 1987 they ruled that polyploid oysters were patentable subject matter, and in 1988 they awarded a patent for a mouse (Lesser 1989, OTA 1989). The mouse contains an activated oncogene and has been called "oncomouse". It is very sensitive to carcinogens, and is being used in testing the safety of substances. The patent extends to all transgenic animals containing an activated oncogene. This patent decision triggered much debate about the ethical issues over patenting.
While accepting the same patentability 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. In 1989 the European Patent Office rejected the patent application for "Oncomouse", but in October 1991 they reversed this decision, and approved it (Aldhous 1991). A 1988 EC draft directive supporting the principle of patents for genetically engineered animals (EC 1988), is still to be approved, but may soon be approved. This decision will continue to be debated, and it is not certain what the outcome will be (Rogers 1992). There is public rejection of the idea of patenting animals in some countries, and Denmark excludes animal patents in a law. Japan and New Zealand tend to follow American patent law, in that they do not have exemptions for living organisms. Japan has granted some patents on animals and plants, and has an additional "Seeds and Seedlings Law" by which intellectual property rights can be granted to plants. For example, in March 1992, Kirin Breweries Ltd. applied for a patent under the Seeds and Seedlings Law on a variety of Turkish Bell Flower containing a bacterial gene which makes the plants small (from 1m to 20-60cm high), doubles the flower number and time of blooming.
Many new discoveries are being patented, both research performed in national and private laboratories. 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, then it cannot be inventive in the patent sense. 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. There are patents on short oligonucleotide probes used in genetic screening because they have a use. If someone can demonstrate a use for a larger piece of DNA then they can theoretically obtain a patent on it.
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. 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.
A patented product that reaches the commercial market gives the inventor some compensation for the time they spent in research for the development. Once a product has been proven effective and safe it may be licensed, then 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 was about US$3 billion, and by the year 2000, it is expected to be more than US$30 billion. The sales from a single product can be very large, for example the sales of the protein erythropoietin (EPO) in Japan are currently Y42 billion annually, and are expected to be Y70 billion annually in a few years. Erythropoietin is used to stimulate red blood cell production in patients with chronic kidney failure. The 1991 US sales were about US$400 million, compared to sales of about US$230 million for human growth hormone.
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 is performed. There may be a greater amount of total knowledge because there is more total research performed. 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. There are also exemptions to patent law if the object is "offensive to (general) public morality", which could prevent the patenting of some animals.
In 1991 a controversy arose when a a single patent application for 337 human genes was made in the USA (Roberts 1991a). This has raised questions about patenting policy. In February 1992 an application for patents on another 2375 genes was made by the same people. Modern technology has the ability to sequence all of the 100,000 human genes within several years. Further applications for several thousand human genes will follow. However, there is no demonstrated utility so this type of broad application is expected to fail, regardless of ethical or policy issues. The patents were applied for on behalf of the US National Institutes of Health, though many inside the NIH are against it (Roberts 1992). This government body may sublicence particular US companies to pursue research on these genes in an attempt to "protect" the US biotechnology industry from international competition. However, researchers in Britain, France and Japan are also obtaining many gene sequences (including some of the same genes and sequences), so a patent war may begin, and international scientific cooperation in the human genome project will be seriously damaged. It could take years before courts decide on the validity of such patents, so more applications are expected just in case a patent office recognises such applications. Actually, the publication of such sequence markers will make it more difficult for companies to patent those genes and could discourage research. Governments are debating what policy should be made. The French government, and Japanese genome researchers (Swinbanks 1992), have announced that they will not apply for similar patents because of ethical reasons. England's Medical Research Council (MRC) has applied for a similar patent on more than 1000 genes, though England is joining France in calling for an international agreement to waive any of these patents if they should be granted (Aldous 1992). The human genome is common property of all human beings, and no one should be able to patent it (Macer 1991). Public opinion could force a policy change regarding the patenting of genetic material, even if it is judged to be legally valid. The policy should be made considering all the economic, environmental, ethical and social implications, and it should be internationally consistent.
There may be better alternatives to patenting plants and animals. 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 (Lesser 1991). 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.
However, there is still no reward given to the farmers who for millenia have established crop varieties, which plant breeders use as starting materials. It is ironic that small farmers continue to lose their farms in the development of commercial biotechnology. 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". Since then an international network of gene banks has begun to be established, who will provide genetic material worldwide. These also preserve genetic material from species that are becoming extinct because of environmental destruction.
An effort to examine this question of patenting life was made using a question (Q17 for the academics and teachers, Q18 for the public) that was modified from one used in .New Zealand (Couchman & Fink-Jensen 1990). The patenting of genetic material derived from humans was added to the other questions, as shown below:
New Inventions, such as consumer products
Books and other information
New plant varieties
New animal breeds
Genetic material extracted from plants and animals
Genetic material extracted from humans
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 5-1. 90-94% of all groups agreed with the patenting of inventions in general, such as consumer products. There was less consensus on the patenting of other items, though the same relative order of items was followed in all groups in Japan and New Zealand. The proportion of respondents who disagreed with the patenting of all items was greater in New Zealand, because many Japanese respondents chose the "don't know" response.
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, but even less, 38%, in Japan. There was even lower acceptance of patenting "genetic material extracted from humans", in Japan only 29% of the public agreed, while 34% disagreed. In all groups more people disagreed with the patenting of genetic material extracted from humans than those who agreed with it.
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 scientists in Japan. There was significantly more acceptance of patenting of all subject matter (except book) by company scientists compared to university and government scientists (Table 5-2). The comparative results in Japan and New Zealand are presented in Table 5-3, and in Figure 5-2 and 5-3.
Table 5-1 Attitudes towards
|% heard of patents||
Inventions, such as consumer products
Books and other information
New plant varieties
New animal breeds
Genetic material extracted from plants and animals
Genetic material extracted from humans
Table 5-2 Attitudes towards
patenting by company, government and university scientists Q17:
Yes= approve No= disapprove DN= don't know
|P & A genes||62||21||17||35||30||35||45||31||24||46||28||26|
Table 5-3 Public opinion over patenting
Comparison of the results obtained from surveys conducted
in New Zealand (Couchman & Fink-Jensen 1990) with those obtained
|Subject matter:||Results expressed as % of total supporting patents for|
|New Plant Varieties||71||60||66||78||49||61|
|New Animal Varieties||59||49||63||74||51||60|
|Plant & animal "genes"||51||37||53||46||34||38|
In light of the results of this survey, it is clear that people may not agree with the patenting of genetic material extracted from humans. International studies should be made, and consideration given to some exclusions. There is also much opposition against patenting animals, and genetic material extracted from plants and animals. Actually, there is industrial opposition to broad patents of some classes of subject matter. However, the informed public should decide.
If it is not thought to be appropriate to exclude all patents, the eligibility criteria could be redefined, so that only specific genes, or their proteins, which have immediate usefulness could be patented. This would receive the support of industry. It may still be appropriate to patent some processes, such as the process to produce a protein of proven therapeutic use to human beings, or animals, or the environment. This would encourage research, while recognising the public opposition against general patents of some materials. This survey result did not examine which aspects of the patenting of human genetic material was supported or rejected. It could be that public opinion rejects the patenting of human genetic material for any purpose. Nevertheless, this question must be examined further and public opinion should be reflected in the policy of the patent offices, internationally.
An alternative to the patenting of plant and animal varieties is to allow animal and plant breeding rights, with exemptions for farmers and for researchers. Under such breeding rights, the breeders would have the first option to distribute the new variety for a limited period, but they would lose this distribution claim if they did not make it openly available to all at an affordable and reasonable cost.
We must question the goals of human life, society, and the current economic system. The goals which drive the national and multinational biotechnology industry, may not be sustainable in terms of the environment, or of stable international trade relationships. These are the real questions of biotechnology. The consequences of biotechnology upon global economics and trade are of another magnitude greater than the regulation of genetic engineering in terms of consumer or environmental safety. It is very important for the public to focus attention on these commercial issues, which are already affecting the lives of millions of people who have lost their source of income by product substitution. We need to chose research goals which will benefit all of humanity, not only having a short-sighted view of national priorities.
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