Concepts: Transgenic animals and ethical issues

3.1 What a transgenic animal is

A transgenic animal has an extra gene inserted by manipulation and expresses it. Such animals have been made from rats, rabbits, pigs, sheep, cows and fish, though mice make up more than 95 per cent. The questions worth asking are why they are made and what humans gain from them.

3.2 Five reasons for making transgenic animals

Normal physiology and development: a designer animal can reveal how a gene is regulated and what it does in ordinary body function and growth. A complex factor such as insulin-like growth factor can be studied by adding genes from another species that change how the factor forms, and then watching the biological effects.

Study of disease: many transgenic animals are made to show how genes contribute to disease. They act as models for human diseases, which makes it possible to test new treatments. Models now exist for cancer, cystic fibrosis, rheumatoid arthritis and Alzheimer's disease.

Biological products: some medicines contain biological products that are expensive to make. A transgenic animal can be given the DNA that codes for such a product and then used as a living factory. The human protein alpha-1-antitrypsin, used to treat emphysema, is one example, and similar work is in progress for phenylketonuria and cystic fibrosis. Rosie, the first transgenic cow, gave milk in 1997 that carried a human protein, at 2.4 grams per litre. The milk contained human alpha-lactalbumin, which made it nutritionally more balanced for human babies than ordinary cow milk.

Vaccine safety: transgenic mice are being developed to test how safe a vaccine is before it is used on people. Transgenic mice already serve in polio vaccine safety testing; if their results hold up, they can replace the monkeys used for batch checks.

Chemical safety testing: the term also covers toxicity and safety testing, and the routine is the one already used for drug toxicity. The animals receive genes that leave them more sensitive to poisons than ordinary animals. A test substance is then applied and its effects recorded in less time.

3.3 Ethics, regulation and patents

Manipulating living organisms cannot continue without rules. Ethical standards are needed to judge whether human activities that help or harm living organisms are morally acceptable. Beyond morality, there is a biological question: a genetically modified organism released into an ecosystem can behave in unpredictable ways. For these reasons the Indian government set up bodies such as the Genetic Engineering Approval Committee, or GEAC, which decides whether GM research is valid and whether a GM organism is safe to release for public services.

Using living organisms for public services such as food and medicine has also created problems over patents. Public anger has grown because some companies have been granted patents on products and technologies that use genetic material, plants and other biological resources that farmers and indigenous people of a region developed and used long before. Rice is one example. India has an estimated 200,000 rice varieties, among the richest collections in the world, and Basmati is distinct for its aroma and flavour, with 27 documented varieties grown in India. In 1997 the US Patent and Trademark Office granted an American company rights over Basmati. The company could then sell a new variety at home and abroad, even though the variety came from Indian farmers' rice crossed with semi-dwarf types and was presented as an invention. The patent extended to functional equivalents, so other sellers of Basmati could be restricted. Similar applications have tried to claim patents on turmeric, neem and other Indian herbal knowledge and processes. If such applications are not challenged, other countries or individuals can profit from this legacy.

3.4 Biopiracy

Biopiracy means that companies and other organisations take bio-resources without asking the country and the people who own them, and without paying compensation. Most industrialised nations are financially rich but poor in biodiversity and traditional knowledge, while developing and underdeveloped countries hold both. Traditional knowledge about bio-resources can be used to develop modern applications and can save time, effort and money during commercialisation. There is a growing sense of injustice about inadequate compensation and unfair benefit sharing between developed and developing countries, so some countries are drafting laws against unauthorised use of their bio-resources and traditional knowledge. India has passed the second amendment to its Patents Bill, which tackles these concerns along with patent terms, emergency provisions and research initiatives.

3.5 Exam pointers

For the five reasons, use the textbook headings and one example each. For biopiracy, the definition plus the Basmati or turmeric example is enough for two marks. A common mistake is to treat the GEAC as a patent office; it approves research and the release of GM organisms, it does not grant patents. Another is to forget that Rosie's importance lies in the human protein in her milk, not in the volume of milk.