DAMODARAM SANJIVAYYA NATIONAL LAW UNIVERSITY SABBAVARAM,

VISAKHAPATNAM, A.P., INDIA

PROJECT TITLE
The Evolution of Human Rights in the Age of Biotechnology

SUBJECT
Biotechnology Law

NAME OF THE FACULTY

Dr. Neelima Boghadi

Name of the Candidate

Roll No.
Semester

ALLU. SAI SARAYU

“2018007”
SEMESTER- 8

DATE OF SUBMMISSION:5-04-2022

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ACKNOWLEDMENT

I would like to extend my heartfelt thanks to my faculty Dr. Neelima Boghadi MADAM, for his
constant support and guidance without which this project would not have been successful despite
my efforts. Also my sincere thanks to Damodaram Sanjivayya National Law University,
Sabbavaram for providing me with all the necessary sources and perfectly guiding me in the
preparation of my project.
ALLU. SAI SARAYU
2018007
SECTION A

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INTRODUCTION

HUMAN RIGHTS

Human rights are meant to protect and treat all people equally and with the utmost dignity. These
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rights are inalienable, irrevocable, universal, dynamic, fundamental, and necessary for a human
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being to live with dignity and respect in accordance with his or her choices.
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These rights, however, are never absolute.

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Human rights have been embraced, developed, and advanced in the perspective that anyone and
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everything has a right to them and that every human being should be treated with dignity and
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equality; and that no human being should be treated inhumanely. should be discriminated against
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on the basis of "birth, sex, cultural differences, caste, colour, creed, and other factors" language,
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and so on."
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To understand human rights in a comprehensive form, the below captioned definitions are to be
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seen and understood.

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a “Dr. Justice Durga Das Basu defines “Human rights are those minimal rights, which every
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a individual must have against the State, or other public authority, by virtue of his being a ‘member
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a of human family’ irrespective of any consideration. Durga Das Basu’s definition brings out the
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“The Universal Declaration of Human Rights (UDHR), 1948, defines human rights as “rights
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derived from the inherent dignity of the human person.” Human rights when they are guaranteed
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by a written constitution are known as “Fundamental Rights” because a written constitution is the
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fundamental law of the state “.

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“The Protection of Human Rights Act, 1993; s-2 “(d) “Human Rights” means the rights relating
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to life, liberty, equality and dignity of the individual guaranteed by the Constitution or embodied
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in the International Covenants and enforceable by courts in India;”1.

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Human Rights & Biotechnology. a a a a

Where the world, industries, corporations and companies are focusing on increasing the longevity
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of their consumers aka Human beings and their life expectancy; biotechnology and bioscience
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are playing a vital role in improving and nourishing human lives. However, due to the disparity
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in economics, social and political structure; human rights are being selectively or non-effectively
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implemented or protected. However, on the positive side, biotechnology is improving and

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https://www.indiacode.nic.in/bitstream/123456789/11184/1/the_protection_of_humen_rights_act_1993.pdf

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a uplifting human lives and even protecting and enhancing them. In this modern era biotechnology
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a has given life saving drugs, antibiotics, antidote, serums, genetically modified products,
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a recombinant DNA, etc.; which has a great positive effect on human lives as well as economics of
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a the country. But with such positive developments there have been some ethical as well as moral
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a violations which at last can be seen as human rights violations. This short article looks into what
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a is the current scenario of human rights in the field of biotechnology and how human rights are
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a being guaranteed in the context of biotechnology.

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EVALUATION OF HUMAN RIGHTS IN BIOTECHNOLOGY ERA

In February 1997, Dr. Ian Wilmut introduced the world to the first successfully cloned mammal,
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a sheep named Dolly, drawing widespread attention to the rapid advances being made in the field
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of biotechnology. The result of this expansion of scientific horizons will be unprecedented

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knowledge of the building blocks of human life and how to manipulate them. The implications of
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these developments have been a growing concern of scientists, industry, governments and
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international organizations for years. More recently, they have also become the subject of much
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public attention.
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In evaluating the issues raised by biotechnology, a balanced approach is essential. Biotechnology

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has potential benefits to offer, and should not be viewed simply in terms of the difficult issues
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that it raises. Its future will be determined by how well national governments and international
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organizations are able to regulate the application of the technology so as to maximize its benefits
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and minimize its problems.

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The biotechnology debate covers a vast range of issues. Biotechnology invites us to re-examine
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concerns ranging from reproductive technology to the rights of those indigenous peoples whose
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genetic samples are used in biotechnological research. It also creates new areas of human rights
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discussions with far-reaching implications for future generations, dealing with such processes as
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germ-line manipulation (altering the genes in egg, sperm, or embryo cells to change
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characteristics of the developing fetus), and genetic screening (using genes to test for genetic
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disease and genetically influenced traits).

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Global Biotechnology

In 1995, the term biotechnology was defined as a set of tools that can be used to make or modify
organisms. The primary industries that are involved in the development of biotechnology are the
European Union, Japan, and the United States. These regions represent the largest producers and
consumers of biotechnology.

The relationship between academia and industry is very important because research related to
biotechnology can be done at universities. The US leads in basic research due to its universities'
less government regulations. Japan, on the other hand, excels at applied research due to its long-
term approach to technology development.

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The European Union has implemented various regulations aimed at regulating the release of
genetically modified organisms or organisms. These include restricting the patenting of life
forms. The EU's regulations have also helped resolve the various issues that arise when it comes
to regulating biotechnology.

Potential Benefits of Biotechnology

Through the Human Genome Project, scientists can now study the various components of human
life. They will be able to identify the genes of every individual.Biotech has the potential to shape
the future of life on Earth by altering the genes of organisms. It has already been used to make
food additives, improve the environment, and develop new cleaning agents.

Most people will eventually be affected by the advances in biotechnology. In the future, direct
manipulation of human genes could be performed on the basis of germ-line manipulation. This
process could eliminate many genetic defects. At present these defects cannot be altered, but with
new GLM techniques, doctors will someday be able to offer parents the possibility of replacing
defective genes with healthy working copies.6

Future medical advances are not limited to the manipulation of microorganisms and the human
genome. Biotechnology may soon produce animals genetically altered to develop organs for
human transplants and to produce compounds in blood or milk that can be harvested and used in
human medications. The Roslin Laboratory in Scotland, where Dolly was cloned, successfully
added a human gene to another cloned lamb, Polly, born in July 1997, and hopes to develop
mechanisms to turn animals into living pharmaceutical factories.7

Potential Misuses of Biotechnology

Human rights and biotechnology have garnered increased attention due to the potential harmful
uses of these technologies. The Declaration was heavily influenced by the scale of the atrocities
committed during the war. Concerns about biotechnology also emerged due to the Nuremberg
trials. Following the announcement of the Dolly Project in 1997, concerns about human cloning
and eugenics emerged. The term eugenics was first used by Francis Galton in 1883. It suggests
that selective breeding could result in a superior human species.

Using genetic screening and germ-line manipulation, it is possible to create human beings with
traits that are considered undesirable by society. For instance, traits such as height and skin color
could be altered to eliminate them. Eugenics is also seen as a way to create a new aspect of the
wealth gap. It is important to note that changes in the genetic composition of a child can affect
his or her descendants.

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Although people may have different ideal children, the similarities among them would
eventually dull the genetic diversity. This could have detrimental effects on the development of
human species. Eugenics could also limit the ability of the species to evolve.

While human cloning and eugenics are still in the works, the potential for genetic discrimination
and privacy invasions is growing. The mapping of the human genome could allow scientists to
study a person's entire genetic information before they are born.

Human beings with certain traits could also be subjected to discrimination due to their
intelligence and health. With genetic screening, it is possible to determine a person's
susceptibility to various diseases. Intelligence and health are two areas where potential
discrimination could occur. With genetic screening, it could be possible to predict a person's life
expectancy and susceptibility to various diseases. Employers and schools could use this
information to make informed decisions regarding a person's employment or education. Privacy
concerns could also arise.

Rights of Indigenous Peoples

Human rights concerns arise from both research methods and the potential misuse of its
application. Biotechnology research and development rely upon the accumulation of genetic
samples. Because these samples may be obtained in the process of routine medical examinations,
questions arise about the informed consent of the sample donors, particularly with respect to
indigenous peoples. Indigenous peoples are defined as traditional groups whose ancestors
inhabited a territory before people of a different ethnic origin came to dominate it.10 Most of the
world’s indigenous peoples live in developing nations.

Over time, exposure to diseases can give rise to acquired genetic immunity. Inhabitants of
developing countries often have natural defenses against diseases that inhabitants of developed
nations do not, and vice versa. Researchers want access to genetic samples from indigenous
peoples, whose genes have remained isolated, in order to learn more about what genes cause
these differences.

Many people worry that companies will exploit indigenous peoples by obtaining samples for
research without informed consent and then failing to share the benefits of resulting
breakthroughs. It is now recognized that indigenous peoples must be allowed to decide whether
or not they will be participants in genetic research. Yet can informed consent be given when
people may not understand the nature, purpose, or potential consequences of genetic research
and technology?

In some cases, indigenous groups may consent to research but have strong moral objections to
the industrial aspects of biotechnology. In particular, many groups object to the patenting of
genes, something acceptable in one form or another in many developed nations, including the
United States, Japan, and the European Union.11

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UN Research Guidelines

Three recent UN agreements address human rights concerns stemming from research in
biotechnology.

The UN's Convention on Biological Diversity was established in 1993 to conserve biodiversity.

The convention encourages the development of biotechnological research and the sharing of
technology with developing nations. It also sets a framework for compensating donors.

The guidelines for biotechnology research were developed by the International Bioethics
Committee, which was established by UNESCO in 1992. The committee's goal was to create an
international agreement on the protection and promotion of the human genome.

The convention also calls for the establishment of ethics committees and the promotion of the
principles it has established. It also asks the International Biotechnical Commission to identify
and prevent violations of human dignity.

The convention recognizes the importance of human genetic diversity and the various factors
that affect it. It also talks about the effects of genetic reductionism.

The convention states that reductionism is harmful and undermines the concept of human
dignity. It also states that genetic testing and manipulation should be strictly regulated. It also
extends the concept of human rights to genetics.

The declaration doesn't talk about the rights of future generations. For instance, it doesn't address
the conflict between the right to an unaltered genome and the right to benefit from science.

The convention states that everyone has the right to life, liberty, and security of person. It also
states that anyone is entitled to the free development of his or her personality. A case can be
made that the use of genetic manipulation in the future, beyond correcting medical conditions, is
a violation of the rights of the child. This issue is similar to the abortion debate. However,
because of the heritability of the germ-line, the rights of the child are not just those of the child.

A draft declaration on the rights of indigenous peoples aims to provide more comprehensive
protection for their genetic resources. It also recognizes their right to sue for compensation for
their property taken without consent. Human rights are protected globally through various
international treaties and resolutions. These include the Universal Declaration of Human Rights
and the International Covenants on Human Rights.

In this article various international laws and regulations that are applicable to the activities
related to biotechnology are discussed . Also, I will talk about the human rights that are protected
in this field. These laws and regulations are not limited to India.

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● “Universal declaration of Human Rights - UDHR” : This declaration protects any human’s
right to “dignity, integrity, equality and self-assurances” in relation to the biotech research which
focuses on human life, body or any of its elements. This assures

that no human right as mentioned above in this point can be violated or infringed by any biotech
lab, research facilities or companies for developing or by experimentation.

● “International Covenant on Civil and Political Rights - ICCPR” : This covenant ensures and
protects that no human being shall be subjected to any medical, scientific, experimental research
or testing without the consent of the person participating or being subjected to. However, now
the question of informed consent comes into picture and sadly it is still developing in this arena.

● “The International Covenant on Economic, Social and Cultural Rights – ICESR” :

This covenant protects the right of indigenous people as well as the right of traditional
knowledge, where no one or no company can exploit and commercialise and monetise the
product or traditional knowledge of the indigenous people. This ensure that if any traditional
knowledge or resource or compound is used for commercial processes the tribal or indigenous
people or people having that traditional knowledge from which these were taken have to be
economically compensated or restituted.

● “The Paris Protocol to the Convention on Human Rights and Biomedicine, 1998” :This
protocol prohibits any research or experimentation which intends to create,experiment and
evolve any research which tries to replicate or create a genetically

identical human being; which means it prohibits human cloning.

● “The Strasbourg Protocol to the Convention on Human Rights and Biomedicine,2002” : This
protocol protects the right of human dignity in the context of organ transplantation and
development of human tissues and organs through genetic

engineering.

● “Universal Declaration on the Human genome and Human Rights” : this agreement focuses on
biology/ biomedicine, genetic and property rights. It protects human rights and human rights,
where the research or invention is detrimental to the human beings as a whole, or for the dignity
of human, animals or plants or even the environment; then those inventions of property may be
excluded from the protection given under the intellectual property rights.

● “Universal declaration on Bioethics and Human Rights - UDBHR”: the aim of this declaration
is to protect and promote respect for human beings, their fundamental freedoms and their rights
which are governed and given by international law. This declaration also prohitbits
discrimination on the bases of genetic charfectristics and data. This declaration aims at providing
an ethical framework to guide biotechnology research and development practitioners. “Article 1 -

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“the human genome underlies the fundamental unity of all members of the human family, as well
as the recognition of their inherent dignity and diversity. In a symbolic sense, it is the heritage of
humanity.”

● “Biological Diversity Act, 2002” : This act focuses on preserving and protecting traditional
knowledge, as well as providing a system for access to genetic resources available within india.
This act has created national, state and local biodiversity boards or and committees which
overlook this process of accessing traditional knowledge and resources and ensure that the
indegenous people and their resources are protected. It also provides for benefit sharing between
the researcher and the traditional knowledge or resource holder. This act focuses on seeing that
the local and idegenous people and our nation's resources are not exploited.

● “The environment Protection Act, 1986” : As per this act, genetically modified foods have
been kept in the category of hazardous substance and because of which the ministryof
Environment and Forest has=d established rules governing genetically modified foods. the rules
have than create the following committees for regulating, assessing and supervising genetically
modified food.these committees are- “Recombinant DNA Advisory Committee - RDAC; Review
Committee on Genetic Manipulation - RCGM;

Institutional Biosafety Committee - IBC; Genetic Engineering Approval Committee - GEAC”

● “Biopiracy and Traditional Knowledge Digital Library” : This library has a database over 34
lac pages on traditional knowledge and its existence. This library's aim is to see that no foreign or
domestic entities misuse or exploit or gain from misusing this traditional knowledge. This library
monitors globally and sees that no traditional knowledge is being misappropriated. it ensures
effective detection as well as takes corrective actions.

● “Biotechnology Regulatory Authority of India, Bill 2013” : The Lok Sabha had referred this
bill to a committee in 2013 and a report has also been published, however ratification of the bill
is pending. This piece of legislation is an umbrella code or act which will govern biotechnology
dynamically throughout india. Its aims are to create a nodal agency to monitor and regulate, and
also to create tribunals for effective adjudication. This bill also encompasses provision for
protection, utilisation of TK,

benefit sharing etc. however the main aim is to regulate, administer and adjudicate.

● “Supreme court of India, Protecting Human Right, GM Food, Aruna Rodrigues and Others Vs.
UOI” : this case was relating / for seeking permission field trials of genetically Modified Food.
The SC constituted a technical expert committee, the committee reported that the field study of
GM Food should be given a moratorium till further research is available. The court as well as the

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committee was of the opinion that naturally nowhere in the world is GM food being widely
consumed and these foods should be tested for toxicity before it can be commercialised.

● “Right to Health, Article 21 Constitution of India; Article 12 ICESR and UDHR” :

These provisions ensure that any biotechnology or biomedical which has novel impacts or are
essential for cure of genetic disease, therapy and other novel purposes should be “accessible,
equitable, should have no side effect, efficacious and acceptable”.

India's Message :

Human Rights and Biotechnology In this era India has the power to shape the global regime in
the context of Biotechnology, as India has become a hub for development, experimentation and
research for everything related to biotechnology. and with this stature which India has achieved ,
now it is also demanding that all Human Rights have to be protected and that all ethical
standards established within India and globally which have been ratified are to be followed and
any violation of such ethical or legal norms will not be tolerated. However, time will tell us
whether human rights are given a paramount footing or development of biotechnology.

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