Basic Life Sciences Free Preview. Buy eBook. Buy Softcover. FAQ Policy. About this book Allen I. Show all. Independent clinical review of drug safety is already standard in most countries, and to be ethical, we must ensure that all people of the world share its protection.
Such protection should be standardized, but it is a more difficult question when a country wants to impose stricter standards. A government has a duty to allow beneficial products and technologies to be used by its citizens, including unconventional treatments such as somatic cell gene therapy. This system has also been extended to some new food products. Another group of products that are made from genetically modified organisms GMOs are food additives, such as amino acid supplements.
The question is how to examine their safety. In impure batches of an amino acid L-tryptophan were associated with many cases of a disease, eosiniophilia-myalgia syndrome, which led to 27 deaths in the USA in The L-tryptophan preparation was produced by Showa Denko, and the cause was insufficient filtering of the preparation, so that one substance was left in the preparation that later was converted to a toxic substance. The substance could have been easily removed by a charcoal filter, but they attempted to save costs.
The preparation was made from a genetically modified bacteria, but that was not the cause. Subsequently in the USA, the Food and Drug Administration FDA decided to submit L-tryptophan to the testing procedures required for a drug rather than the looser regulations required for a food additive. Not all food additives may need to pass the extra safety tests, but this case must be considered when regulating food additive safety.
Public opinion finds there is more concern about the consumption of products made using genetically modified organisms in Japan than in New Zealand. In all countries surveyed there is less concern about consumption of vegetables than about the consumption of dairy products and meat made from genetically modified organisms [8, 9]. The major issue that is facing regulators and consumers, is how foodstuffs made from varieties of organisms that have been made by genetic engineering should be regulated. New varieties of plants and animals that are used to produce food have been constantly introduced to expand the range of foodstuffs.
We can think of kiwifruit, as a stunning example of the rapidity of adoption of a new variety of foodstuff. In general, these foodstuffs are introduced with no safety concern, and in most cases the varieties made using genetic engineering should be harmless, or perhaps even safer than existing foodstuffs. The conclusion of international working groups [23, 24] is that in general there should be no harm to human health and therefore they do not require any special regulations . We are already consuming harmful foodstuffs that have been handed down to us for generations, especially some types of seasoning and spices, and beverages.
Compared to the risks from these foodstuffs, the new crop varieties should generally present no significant risk. The US Food and Drug Administration opposed systematic labeling of foods made from plant biotechnology in A description of FDA procedures for approval of foods from genetic engineered organisms is Henkel . The FDA exempts food from case by case review unless there are signs that there will be a problem, for example an allergic reaction.
This has been criticized by some, especially the decision to leave it up to industry to decide, and also that labels may not be necessary for some products. Some local governments want to regulate, and Chicago passed a local law requiring all foodstuffs made from genetically engineered organisms to be labeled as such Nature Some companies like Zeneca and Calgene which market tomatoes with delayed softening support the idea of labeling because this removes suspicion from the public mind and gives choice .
Voluntary guidelines have been followed since Each year a public report is issued including the details of each submission, the arguments discussed, data that was presented, and recommendations made. This is quite consistent with the ethical concerns, because there is no reason to single out one method of food preparation. Product-based assessment is a theme seen in both the UK and the USA, and in most international reports on the subject.
In both countries labeling and review is not statutory, but the choice to do so is often voluntarily made. The UK committee does not recommend labeling if there is no viable genetic material in the final food to be consumed, for example in oils. There is little work on this in Asia, except for Japan. The Japanese Ministry of Health and Welfare guidelines for foods and food additives produced by recombinant DNA techniques excluded organisms that have gene deletions from these guidelines, only including organisms which contain "recombinant DNA" sequences or parts of vectors.
The "expert committee" of the Ministry will review all cases "to ensure and sustain reasonable criteria", and they can decide whether to insist on additional data from safety tests or not. The data presented must be published in peer reviewed journals. The Group of Advisors on Ethical Aspects of Biotechnology to the European Commission , recommended that food be labeled to indicate when its composition and characteristics have been substantially modified by genetic engineering techniques, but said that labeling was inappropriate when changes are insubstantial.
They recommended article 2.
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Basically these labels apply when the product is significantly changed in composition, nutritional value or intended use. Generally they focus on the product rather than the process. European Union Novel Food and Novel Food Ingredient Legislation was passed in and provided a statutory basis for all EU countries, and food will only be sold in one EU country if no other country objects. There are disputes over labeling requirements, seen in with the proposals to import soybeans.
Because these beans are mixed after farming, it is difficult to know which beans are from GMOs and which are not. The OECD  has had several workshops on the subject of safety of novel foods, and in held a workshop in Oxford, UK, which used the principle of substantial equivalence, and concluded that the same approach could be applied to microbes, plants and animals. Substantial equivalence suggests that existing organisms used as food, or as a source of food, can be used as a basis for comparison when assessing food safety .
They considered three situations:. If substantial equivalence is established they considered that the novel food be treated the same as the familiar one.
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If there was a new trait, then the evaluation should be case-by-case for the product of the gene. Some of the factors considered important in evaluation are the source, identity, construction, effect, degree of digestibility, allergenicity, stability of the trait, protein and any products of its action secondary metabolites , site of expression tissue specificity and colonization potential for microorganisms . In the case that a novel food does not have substantial equivalence to a current food, then safety testing was called for.
In conclusion a balance must be found between the right of consumers to information and the imposition of unnecessary information which may confuse people over what are the major facts relevant to their diet, e.
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Whether the information should be in the form of a label or an information sheet, and what should be in that information e. Equity demands, that we should ensure that all people of the world enjoy the protection of similarly high safety standards, and that they are kept informed of the content of their food. We may not need to apply any additional regulations to food, unless novel components are introduced to the food.
The policy has recently been formulated in several countries. In a rapidly moving and new area, an independent committee approach to regulation is the only way to efficiently and safely examine food safety. The key question is whether they decide the foods are novel or not, because if they are novel, extensive safety tests must be performed.
International food safety and environmental standards should be speedily developed to ensure that all people of the world share their protection, and no country becomes a testing ground for new applications. Human rights need to be increasingly respected so that we get social progress in addition to scientific progress.
All people should equally share both the benefits of new technology and the risks of its development. All people should share in the benefits of biotechnology. 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. 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 intellectual property discussed below. Much of the new wave in biotechnology research is being performed by private companies. Research has for many decades also been viewed in terms of the business opportunities, both internationally and within nations. 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. Research facilities include universities, government and private research institutes, and hospitals.
The funding sources in different countries come from government, charity or industry. 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, because of the long period of research required before any profits are made , and also many patent claims are contested in lengthy court battles with inconsistent rulings in different countries.
In Japan, government ministries and large multinationals have been the major investors in biotechnology from the early 's, because of more difficulty in establishing small companies than in the USA. Internationally, there will be more competition between different multinat ional companies than countries. Industrialized countries have been gathering seeds and genetic resources from other countries for centuries, for the development of new crops and products . In , 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.
In the Biological Diversity Convention was ratified. Developing countries do possess such resources, but want to minimize the loss of control over them, and preserve them. Genes are raw materials for biotechnology, and there is not always free access to genetic material. Internationally, there is a network of gene banks, and some do provide free access to the materials stored. 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.
One of the social issues is whether applications should attempt to preserve rural structure. 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 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 was warmly welcomed because it reduces imports of milk powder.
Nevertheless, there are many definite benefits for all countries from biotechnology, which should direct research attention to these ends. Most will be guaranteed a stable internal food supply. There are other uses, for example, 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.
The question of patenting live organisms and genetic material is a contentious issue. 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 recognized depository. In the US Patent Office awarded a patent for a maize variety, in they ruled that polyploid oysters were patentable subject matter, and in they awarded a patent for a mouse [34, 35].
The mouse contains an activated oncogene and was 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 the European Patent Office rejected the patent application for "Oncomouse", but in October they reversed this decision, and approved it . A EC draft directive supporting the principle of patents for genetically engineered animals, was debated for years before being rejected. There is public rejection of the idea of patenting animals in some countries, and Denmark excludes animal patents in a law. 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.
It is unclear how the GATT rules will be implemented. Methods for gene sequencing, or mapping, or expression, can be invented and patented. 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. The system is self-sustaining, as there is less incentive for companies to conduct research if they cannot obtain patent protection to allow them exclusive marketting of the product for some period before generic products copies can be marketted.
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.
Some of the reasons against extending patents to plants and animals include: lack of evidence that patents do stimulate invention, distinction between discovery and invention, need to allow access to the organisms, extended protection, the ideas of biotechnology were developed in the public, no special reason to privatize public goods, need for uniform utility patents, and inequality among the different countries in access [38, 39]. New medicines may still be developed without patenting animals.
The human genome is common property of all human beings, and no one should be able to patent it beyond specific uses of genes . There is public rejection of the patenting of genetic material from humans, and there are also many who reject patenting of genetic material from plants and animals. This is seen in the results of the International Bioethics Survey shown in Table 1 . In the Japanese study , 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 books by company scientists compared to university and government scientists Table 2. There may be better alternatives to patenting plants and animals such as the UPOV Convention which established international "plant variety rights". 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 millennia 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 , at a UN Food and Agriculture Organization conference, representatives from countries recognized 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, which provide genetic material worldwide.
These also preserve genetic material from species that are becoming extinct because of environmental destruction. In , world parliamentarians called for a ban on the patenting of human genes and a clarification of rules governing biomedical research. Politicians from national parliaments, meeting in Madrid, approved a resolution on bioethics on 1st April, the final day of the biannual Inter-Parliamentary Union IPU conference.
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The resolution stressed ''the urgent need to ban the patenting of human genes Some equity issues have been highlighted in the media. An indigenous Indian tribe was awarded intellectual property rights to the drug jeevani, from the plant Trichopus zeynicus , called Indian ginseng, Nature , India is challenging the US patent on the use of turmeric to heal wounds, Nature , Scientific research in India was done in , although US researchers claimed a patent recently!
It was known much longer as a traditional medicine, raising general issues. The patenting of a neem tree extract azadirachtin by W. Grace ltd. Population genetics researchers have sometimes collected samples which have led to attempts to patent cells or DNA. In this paper some of the bioethical issues especially risk and equity have been discussed.
Another issue of ethics is who should make decisions, and who do people trust. Surveys reveal differences between countries in who is most trusted as a source of information about biotechnology [9, 42]. Despite the lower trust shown in the government in Russia, they had a level of trust in medical doctors. Companies were least trusted everywhere. Farmers were also not trusted except in the USA.
Decision-making in most Asian countries tends to exclude the public, and biotechnology is no exception. However, biotechnology has led to more public debate then many other issues in the past. In some democracies the public has a clear role in the process of regulation, and clear opportunities to voice concerns. This opportunity to voice concerns is important to gain public trust, especially considering the lack of trust. The survey responses show that the public can make well reasoned arguments concerning biotechnology risk and benefit.
The public should be involved more in committees making science policy and regulating applications of science. This requires more public willingness to be involved, and the scientists and bureaucrats should allow third party and public entry to committees. As a minimum standard for ensuring ethical biotechnology, decisions should be made in forums open to public knowledge. On the other hand, bureaucracy is a challenge for the progress of science demanded by the principle of beneficence.
In researchers in South Korea announced that they had conducted a gene therapy clinical trial for the first time, although the country did not have guidelines at the time . However, if the media reported it in a negative way it could be seen as scientists being too eager to wait for regulations to be drafted, and could weaken trust in public authorities.
Expectations of the public for debate vary between country, but given the global media we could see people expecting to be involved in every country.
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There is a significant public policy decision to be made regarding public education programs. There has been an information campaign underway for a decade in Japan supported by members of the Japan Bioindustry Association, involving government and industry, to promote biotechnology.
It appears to have resulted in high awareness of biotechnology, with mixed perceptions. There are also calls in Europe by industry groups to promote biotechnology, with the goal of reducing what is seen as a high level of concern about the technology. Such campaigns can include publication of books, which can also be useful to promote discussion of ethical issues. Some US companies also have large public relations campaigns, such as Monsanto. However, rather than attempting to dismiss feelings of concern, society should value and debate these concerns to improve the bioethical maturity of society.
However, media responsibility is crucial. Attempts to develop international bioethical approaches must involve consideration of the values of all peoples. We could call this cross-cultural bioethics. This means something different from universalism - attempts to define an international ethical code of what is ethical and what is not, or a table of acceptable and unacceptable risks based on consideration of ethical principles.
We see difficulty in universal recognition of basic laws such as those respecting human rights. However, the existence of international environmental laws, e.
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