Patents and Ethical Issues Madam Noorulnajwa Diyana Yaacob Universiti Malaysia Perlis LECTURE 13 & 14

Introduction 1. With the advancement of knowledge in molecular biology, the capability of modifying genomic structure has increase very drastically. 2. At the early stage of genetic engineering applications (in 1970s), public were very concern about the potential risk & issues related to ethics as the result of application of biotechnology

3. One of the well known example was when a cancer gene wanted to be cloned using E. coli. 4. It was thought that gene from genetically modified E.coli can be transferred to the E. coli in human and can be harmful to human. 5. However, biotechnology had advanced very fast and by 1980s, the multinational companies have produced range of GMO for commercial applications.

6. It is now widely accepted that transgenic technology has a significant contribution to agricultural production as a result of GM crops application. 7. Currently, potential of biotechnology in medical field is also being recognized.

Ethical issues in biotechnology 1. Although biotechnology gives a lot of benefits to the society, but at the same time it also creates certain concerns among the general public. 2. Some people rejected totally biotechnology applications and suggested that the recombinant DNA technology should not be develop at all.

3. The questions that is always asked in relation to the application of biotechnology are related to; Creation of new life forms across species Long-term effects on human health and environment Mixing/transfer of DNA between animal and human 4. Participation of experts, potential beneficiaries and general public is necessary in developing common ethical values so that biotechnology is used in responsible ways.

What are Ethics? 1. Ethics are the rules or standards that govern the way people behave and their decisions on the 'right' thing to do. 2. Ethics are practiced by everyone, every day. 3. The general principles of ethics are; respect for life, and need for a balance between benefit and harm/risk

Ethics refers to standards of right and wrong that prescribe what humans ought to do, usually in terms of rights, obligations, benefits to society, fairness, or specific virtues. Ethics standards include obligations to refrain from stealing, murder, assault, slander, fraud, honesty, sympathy, loyalty. Other ethical standards relating to rights; the right to life, the right to freedom, and the right to privacy. Such standards are are supported by consistent and well-founded reasons.

Current features There are 2 main current features that become the basis of concern; First, the ability to perform manipulate plant and animal genomes is considered intervention to nature. This raises the question of whether or not this is an ethically activity. Secondly, there is concern that with very the rapid advancement will create more new findings. And once technology is available, it is difficult to stop people from using it. The worry is this situation may happen ahead of proper ethical consideration.

Selective breeding has been used since agriculture, however, it is now possible to carry out gene transfers that could not occur in nature. Gene transfers can be done from the animal kingdom to the plant kingdom. Some people have characterized this as 'playing God', with the implication that it is ethically unacceptable to interfere with nature.

Why ethics is important The biotechnology industry faces challenges unlike those faced in other sectors. Research finding in biotechnology often become front-page news, subject to intense analysis by press, academics, government, and consumers. Managers in biotechnology must necessarily think carefully about ethical issues if their companies are to survive.

It is accepted that a corporation obligations not only to its shareholders but also to the general public and customers. A successful corporations always recognize of having responsibilities to a wide range of interested groups and society. Good understanding of ethics is very important to the success of a company who decided to venture into business related to technology.

Ethics is the attempt to help us how we behave when our actions affect other people. Ethics is important because doing the right thing is important. It affects how others feel about us and how we feel about ourselves. In addition, there’s good reason to think that there are competitive advantages in being able to position as a responsible company with integrity.

Ethics issues of stem cell research Stem cell research offers great promise for understanding basic mechanisms of human development and differentiation. It is also hope for new treatments for diseases such as diabetes, spinal cord injury and Parkinson’s disease. Pluripotent stem cells can differentiate into all types of specialized cells. Scientists plan to differentiate pluripotent cells into specialized cells that could be used for transplantation.

Key to this is what actually represents the beginning of life for a human. Opinions on this vary from the moment of conception to a 14 day embryo and a living baby at birth. This issue is highly sensitive, and it will always be necessary to consider all opinions and to balance the harm that might be done against the potential good this research may provide for those suffering from debilitating diseases.

The main objection to stem cell research is that it involves the destruction of an embryo or foetus. People have a different view of the moral status of the embryo, for example that the embryo becomes a person in a moral sense at a later stage of development than fertilization.

Few people, however, believe that the embryo or blastocyst is just a clump of cells that can be used for research without restriction. Many hold a middle ground that the early embryo deserves special respect as a potential human being but that it is acceptable to use it for certain types of research provided there is good scientific justification, careful oversight, and informed consent from the woman or couple for donating the embryo for research

Safety Issues in Biotechnology Biotechnology is a key technology of this century. It now covers range of applications; in agriculture, medicine, food processing, environmental protection, mining, nanoelectronics.

However, altering the genetic structure of living organisms (humans, plants, animals) has created concerns about safety of these new technologies. Until now, most of the safety & ethical issues discussed are related agricultural and medical biotechnology.

Genetically modified food and human health What are the main issues of concern for human health? There are three main issues; Allergic reaction (allergenicity), Gene transfer, and Outcrossing

Allergic reaction The transfer of genes from commonly allergenic foods is discouraged. The traditionally developed foods are not generally tested for allergic reaction. Protocols for tests for GM foods have been evaluated by the Food and Agriculture Organization of the United Nations (FAO) and WHO. No allergic effects have been found relative to GM foods currently on the market.

Gene transfer Gene transfer from GM foods to cells of the body or to bacteria in the gastrointestinal tract would cause concern if the transferred genetic material adversely affects human health. This would be particularly relevant if antibiotic resistance genes, used in creating GMOs, were to be transferred. Although the probability of transfer is low, the use of technology without antibiotic resistance genes has been encouraged by a recent FAO/WHO expert panel.

Outcrossing The movement of genes from GM plants into conventional crops or related species in the wild (referred to as “outcrossing”), may have an indirect effect on food safety and food security. This risk is real, as was shown when traces of a maize type which was only approved for feed use appeared in maize products for human consumption in the United States of America. Several countries have adopted strategies to reduce mixing, including a clear separation of the fields within which GM crops and conventional crops are grown.

Environmental impacts of (GM) modified crops One of the major concerns about planting GM crops is the unsure effect on the environment. The potential problems is that the gene might be accidentally transferred by pollination to other plants, weeds species.

Scientific research has shown that this is technically possible, but the potential long-term impacts this might have are still unclear. There are fears that such transfers could lead to the development of resistant “superweeds”,loss of genetic diversity within crop species, and possibly even the destabilization of some ecosystems.

What are the issues of concern for the environment What are the issues of concern for the environment? Issues of concern include: 1. The capability of the GMO to escape and potentially introduce the engineered genes into wild populations. 2. The persistence of the gene after the GMO has been harvested. 3.The susceptibility of non-target organisms (e.g. non pest insects ) to the gene product.