LEGAL , SOCIAL AND ETHICAL ASPECTS OF BIOTECHNOLOGY

Made by: PRITI PANDEY TYBSC

BIOCHEMISTRY 7218

WHAT IS BIOTECHNOLOGY?

It involves the modification of the basic genetic material in the living subject, which imparts new properties and capabilities in organisms which can be harnessed for a number of useful applications.

good effects of biotechnology in human life

Therapeutics used today have only been made possible with the use of biotechnology, Therapeutics which have been approved are commonly used today to treat a wide variety of diseases such as arthritis, hepatitis, genital warts, anemia, cystic fibrosis, leukemia and some other cancers.

A lot of our antibiotics are derived from naturally occurring microbes, and a great deal of the medicines which are available today are made from plants, such as Digitalis. As a result of this, many plants and animals are now being investigated as sources of anticoagulants.

Digitalis

The Poison Arrow /Dart Frog is being looked into as a way of providing us with painkillers, and a certain type of fungus is found to produce a novel antioxidant enzyme that sucks up free radicals that are know to encourage the growth of tumors.

Yellow Poison Dart Frog

BAD effects of biotechnology in human life

Strictly speaking, there are not bad effects of Biotechnology in human life. If the general population is currently using a product manufactured through biotechnology principles, government regulations ensure the proper testing and quality control of the product to ensure user safety.

However, there are conceptual disadvantages in terms of what is ethically or morally right. Issues surrounding cloning and growing organs in other mammals for use in humans have elicited a good amount of debate about what is ethically acceptable.

The ability to produce specific changes in somatic and germ tissues of living organisms through genetic engineering has raised social, legal and ethical questions that remain unresolved.

LEGAL ASPECTS

Legal aspects are those concerning the protections that laws or regulations should provide.

The globalization of biotechnology brings not only new economic prospects but also new risks.

According to cautionary principle, these risks could be avoided by implementing appropriate technology structuring.

Law appears to be the right way to structure and organize technological actions.

It would be desirable to research and compare the rights of genetic engineering in different countries as well as international regulations.

Steps Taken By Indian Government

The Indian government has entered into a number of biotechnology cooperation agreements with various countries in an effort to foster additional growth in this sector.

Karnataka, Tamil Nadu, Andhra Pradesh, Maharashtra have taken out their specific policies to boost the biotechnology sector in their respective areas.

key steps taken by the State Governments include:

• announcing separate Biotechnology Policy for their States,

• setting up of Task Forces with experts to guide them on policy issues, setting up of exclusive Biotechnology Parks with agriculture and health biotechnology as key areas.

Biotechnology Laws in India

"Recombinant DNA Safety Guidelines, 1990" were released by Department of Biotechnology and these guidelines were further revised in 1994. The revised guidelines are in respect of safety measures for the research activities, large scale use and also the environmental impact during field applications of genetically altered material.

Further, "Research in Transgenic Plants & Guidelines for Toxicity and Allergenicity Evaluation of Transgenic Seeds, Plants and Plant Parts, 1998" [Guidelines].

Institutional Biosafety Committee (IBSC):

IBSC is the nodal point of interaction within a commercial organization/applicant company involved in rDNA research for the implementation of rDNA guidelines. Therefore, in the first instance, applicant company should constitute IBSC comprising of the Head of the applicant company, scientists involved in DNA work, a medical expert and a nominee of the DBT.

Genetic Engineering Approval Committee (GEAC):

In case of large scale field trials, deregulation and commercialization, permission of GEAC constituted under the MoEF is also required.

Import and Shipment of Transgenic Material:

All imports of seeds and planting material etc. will be allowed freely subject to EXIM Policy guidelines and the requirements of the Plants, Fruits and Seeds (Regulation of Import into India) Order, 1989 shall require a permit granted by the Plant Protection Advisor to the Government of India.

Commercialization of GM/Transgenic Crops in India:

Transgenic crops/varieties are tested to determine their agronomic value for at least two seasons under the All India Coordinated Project Trials of ICAR, in coordination with the tests for environment and bio-safety clearance as per EPA before any variety is commercially released in the market.

SOCIAL aspects

Social aspects are concerned with how events may effect the society as whole and individuals in the society.

Includes the needs of various publics to secure meaningful information for involvement in decision-making on development and use of biotechnology.

Biotechnology provokes profound public mistrust. Governments, consumers, farmers and, to a lesser extent, scientists disagree fundamentally on its risks and benefits. The classical humanistic vision that science will naturally lead to social progress has been severely eroded, and scientists bear much of the responsibility.

Rather than expanding the theoretical possibilities of biotechnology, they need to discuss more, and more concretely, "where we want to go" and what roads we should take.

Three principles:

A new contract is needed between all stakeholders - between North and South, between public and private research, between scientists and citizens. Such a contract would be based on three principles:

1)Open dialogue on biotechnology's benefits and risks.

In order to arbitrate between risks and opportunities, we need a wide-ranging dialogue guided by objective information, with multilateral organizations such as FAO playing a key role as honest brokers.

2) Public and private research to respond to key challenges

Research priorities should also put emphasis on key challenges facing developing countries, such as abiotic stresses .The point is harnessing genetic resources through biotechnology, not just manipulating them.

• For example, biotechnology tools can contribute to the conservation, characterization and utilization of biodiversity, through in vitro culture and maintenance of ex situ germplasm collections, and to embryo rescue and artificial insemination for breeding and preserving rare animal breeds.

The key to reorienting research for the benefit of developing countries is funding. We need to better exploit the comparative advantages of public and private research, recognizing that research in this field is an international public good. This means reversing the decline in funding for public research, and creating incentives to harness private/public sector partnerships while protecting the public interest.

3) Access and benefit-sharing

The case of "Golden Rice" - which saw various industries claim some 40 different patented steps at the time of release - is a clear example of barriers to access. On the other hand, we have to recognize that IPRs are crucial to the growth of the biotechnology industry, and that lack of patent protection in a country can limit access to the results of biotechnology originating elsewhere.

IPRs are not a good in themselves, but a tool that society uses to achieve certain objectives,   FAO calls on private sector companies to share their technologies and information with developing countries free of charge or at minimal cost such as placing information in the public sector and promoting innovation.

ETHICAL ASPECTS

Ethical aspects are generally defined as those raising questions concerning what is moral/right.

Some ethical standards are required to evaluate the morality of all human activities that might help or harm living organisms.

Therefore, the Indian Government has set up organizations such as GEAC.

Regulations And Rules

In several countries there are rules, recommendations and regulations in the area of genetic engineering to protect the users and their environment.

In Australia, among many regulations there is the Code of Practice of Care and Use of Animals for Scientific Experiments (1990); the Rules of genetic manipulation on a small scale (1980); the Rules for manipulation of genetically engineered organisms (1990).

Recently, there has been another initiative from the Ministry of Public Health to initiate a National Institutes of Health China project. Scientists are encouraged to establish their own companies, and they can be shareholders while keeping their academic positions for a limited time. Another good thing is the public–private partnerships to boost biotechnology in china.

In Canada -handling recombinant DNA molecules of viruses and cells (1989) are cited.

In India -the Rules of Safety in researches of Genetic engineering and the Rules of Safety of recombinant DNA.

Good And Evil

There is a clear line between the good and the evil, drawn by the COMMON SENSE, and this is the line that will guide the ethics in biotechnology.

Glowing monkey genes raise ethics issues

WASHINGTON — Scientists have created the first genetically modified monkeys that can pass their new genetic attributes to their offspring.

The Japanese researchers added genes that caused the animals to glow green under a fluorescent light and beget offspring with the same ability to test a technique they hope to use to produce animals with Parkinson's, Huntington's and other diseases.

Its an advance designed to give researchers new tools for studying human disease but one that raises a variety of thorny ethical questions.

The other side"Instead of manipulating the genes of marmosets or other nonhuman primates, why aren't scientists harnessing the power of the human genome or any of the other technology that has exploded over the last 10 years?"

Insane Cases of Genetic Engineering

Scientists have successfully genetically altered a goat’s embryo with the DNA of a spider.  These genetically altered goats produced (mutated) in a laboratory are presently producing milk that is being used to make bullet-proof vests. 

Spider goat

Yet, animal rights activists still bewail about the ongoing scientific experiments.  One, they argue, a couple of alternatives exist which do not necessitate tampering with goats’ DNA. These include testing on E.Coli and silkworms.

Two, biosafety problems are rife with the inculcation of foreign genes into the goats. This is further accentuated by the fact that certain viruses and pathogens which are resistant to antibiotics may pass onto the goats- further complicated by the fact that the meat from these cloned animals are being considered for introduction to the human food chain.

Scientists in China have already spliced human genes into more than 200 cows in an attempt to make them produce human breast milk.

Their method involved cloning human genes and mixing them with the DNA in a cow embryo. The embryo was then implanted into a female cow. Their plan is to develop a genetically modified alternative to baby formula which can be given to infants.

Humanized Cow Milk

1. Identical? Science is still to fully discover the

multiple components of breast milk.

2. Animal ethics?What about the implications for

animal ethics in conducting such a procedure.

3. Best for babies?How can it be ethical to thrust a

scientifically unproved food into them, in the

name of simulating breast feeding.

GM cows make human breast milk: 3 reasons it’s wrong