BIOETHICS BIOSAFETY AND INTELLECTUAL PROPERTY RIGHTS Question Papes (2008, Reg)

SET : 1

1. a) Explain the problems associated with ethics with suitable example. b) Explain the key principles of bioethics with suitable example.
2. Explain the key provision in the convention on biological diversity.
3. Explain the following: a) Frame work of bio safety regulations in India b) India's environment act of 1986.
4. Illustrate good practices and regulations; and correlate to the life of a drug, starting from basic research to the manufacturing of drug.
5. Write short notes on: a) Invention b) Term of Patent c) Resolution of patent d) TRIPS.
6. a) IsS UPOV appropriate for developing countries? IS there any alteration to UPOV? Explain. b) Explain PPVFR, 2001.
7. Write short notes on : a) UPOV b) GATT c) WIPO d) PCT
8. Discuss the role and responsibilities of WTO.

SET : 2

1. a) Give the reasons behind acceptance or rejection of genetic manipulations. b) Discuss cross cultural bioethics.
2. Explain the following: a) Cartagena protocol on biosafety b) AIA
3. a) Write the protocols for approval of new transgenic events. b) Discuss about Swaminathan committee recomendations.
4. a) Total quality management. b) QA unit and their responsibilities.
5. Explain the following: a) Patent infringement b) Conditions to which grant of patents are subjected c) Ground of opposition to the grant of patents.
6. a) Describe the exclusive rights of a copy rights owner. b) How can one obtain and enforce his/her copyrights right?
7. Discuss Budapest treaty on the international recognition of the deposit of microorganisms.
8. Explain the role of GAIT and WTO in agricultural subsidies.

SET :3

1. a) Explain future bioethical conflicts in biotechnology. b) Discuss the global issues of technology transfer.
2. Explain in detail the regulations involved in transboundary movement of the LMO's.
3. Write short notes on the following: a) DBT guidelines in approval of transgenesis. b) Transgenic research in agriculture.
4. Explain the following: a) Archiving of Data. b) GLP inspections and enforcement.
5. a) Explain the concept of IP. b) Explain step by step procedure for obtaining a non provisional patent with neat diagram.
6. a) What is the trade sacret and what is not-trade secret? b) HOw patents and trade marks are complimentary?
7. Explain the following : a) PTC b) Madrid system for international registration of trade marks.
8. Explain the following : a) Trade without discrimination b) Open trade.

SET :4

1. Define the term beneficence and write the significance.
2. Explain the following : a) Benefits and risks of GMO's b) NIH guidelines for Biosafety.
3. Explain the following : a) FAO b) Biotechnology industry and rDNA research.
4. Explain the following : a) Archiving of Data b) GLP inspections and enforcement.
5. Explain the following : a) IPR and traditional medicine b) Technology measures which are used to prevent and infringement.
6. a) Enforcement of farmers rights in India. b) Role of TRIPS and UPOV in protecting plant varieties.
7. a) Discuss about Hauge system for the international conventions for the protection of new plant varieties. b) Explain about Brene convention on trade mark rights.
8. a) Explain the role of GATT and WTO in agricultural subsidies. b) Role of WTO in liberalizing trade

SOCIAL AND ETHICAL ISSUES IN BIOTECHNOLOGY

Social and Ethical Issues in Biotechnology include:

• Genetically Modified Organisms
• Genetically Modified Food
• Cloning
• Human Cloning
• Human Genetic Engineering
• Stem Cell Research
• Eugenics
• Brain Computer Interface
• Nanomedicine
• Parthenogenesis
• sperm and Egg Donation

BIOETHICS

Definition : Bioethics is the study of ethical issues /controversies brought about by advances in biology and medicine. Bioethicists are concerned with the ethical questions that arise along with the developments in biology, medicine and related fields like biotechnology.

HISTORY:
Scientific advances have produced many social benifits. At the same time it has left behind some troubling questions. Public attention was drawn to these questions by abuses of human subjects in biomedical and behavioural research, especially during the Second world war.
The Nuremberg code was developed during the Nuremberg war crime trials as a set of standards for judging the physicians and scientists who had conducted biomedical experiments on concentration camp prisoners. Nuremberg code is often considered as a leap starting the interdisciplinary branch of bioethics.
Belmont Report published in 1979 is considered as a touchstone by many bioethicists. In 1974 National Research Act was signed into law in U.S facilitating the creation of National commision for the protection of Human subjects of Biomedical and Behavioural research. After 5 years of study the commision has released a report popu;arly Known as the Belmont report. Belmont Report focuses on Three principles:
1) Respect for autonomy of persons
2) Benificence
3) Justice

Later the principle of non maleficence is added.

To apply the general principles to the conduct of research involving human subjects, the Belmont Report suggested that the following requirements to be considered :
1) Informed consent
2) Risk/Benefit assesment
3) Just and fair selection of subjects of research

Since then Bioethics has grown with the increasing challenges in Public health and health policy, biotechnology. Today Bioetics is a fast growing academic and professional area of inquiry.

As a field of inquiry bioethics recieved boost when American president Clinton created an advisory commitee on Human Radiation Experiments conducted in the U.S between 1944 and 1974.

BIOETHICS; its purpose, ideology and methodology.

Bioethics is helpful in adressing the social and ethical concerns associated with Biomedical, Behavioural and Biotechnological Studies.

Bioethicists play a very important role in the creation of medical and biotechnological research efforts. They even are helpful in predicting or overseeing the possible hamful effects of a research affort well in advance.

Bioethicists are not hired because of their opinion or because they have special skills in reasoning, but because they know and can put to work the enormous body of research and history off discussions about bioethics in a fair, honest and intelligent way.

Bioethicists often focus on using philosophy to help analyze issues. But this aproach is sometimes challenged, and bioethics is becoming increasingly interdisciplinary. Many Bioethicists are coming from vrious fields like Physicians. Some even say that the philosophical point of view had a negative effect on the growth of the field. Some bioethicists, especially those who perform ethics consultation in clinical settings, emphasize the practical aspects of bipethics, and view the field as more closely related to clinical practice or public health than philosophy.

BIOETHICS, BIO SAFETY AND INTELLECTUAL PROPERTY RIGHTS syllabus, JNTU (2007-2008)

UNIT I: BIOETHICS

Introduction to Bioethics. Social and ethical issues in Biotechnology

UNIT II: BIOSAFETY I

Definition of Biosafety. Biosafety for human health and environment. Social and ethical issues.

UNIT III: BIOSAFETY II

Use of genetically modified organisms and their release in to the environment. Special procedures for r-DNA based products

UNIT IV: REGULATORY AFFAIRS

Regulatory requirements for drugs and Biologics. GLP. GMP

UNIT V: INTELLECTUAL PROPERTY RIGHTS I

Intellectual property rights, and Intellectual Property protection, patents and methods of application of patents,

UNIT VI: INTELLECTUAL PROPERTY RIGHTS II

Trade Secrets copyrights, Trade Marks, legal implications, farmers rights, plant breeder’s rights.

UNIT VII: INTELLECTUAL PROPERTY RIGHTS III

International and National conventions on biotechnology and related areas.

UNIT VIII

WTO guidelines

TEXT BOOKS:

1. Sasson A, Biotechnologies and Development, UNESCO Publications, 1988.

2. Sasson A. Biotechnologies in developing countries present and future,

UNESCO publishers, 1993.

REFERENCE:

1. Singh K. Intellectual Property Rights on Biotechnology, BCll, New Delhi.