BIO-ETHICS AND PATENTING
Ethically
speaking, living beings are creations of God, which cannot be owned by human
beings through patents. God is the only owner of all living things on this
planet. Living beings are vested with an inherent dignity and integrity which
is protected and guaranteed. Human beings cannot also play with the wisdom of
God by manipulating living beings since this manipulation hits on human
integrity and dignity. Genetic manipulation of organisms and its protection by
patent system has always raised an issue and cry on moral and ethical issues.
WHAT
IS ETHICS AND MORALITY?
The
term is derived from the Greek word ethos which can mean custom, habit,
character or disposition. Our concepts of ethics have been derived from
religions, philosophies and cultures. They infuse debates on topics like
abortion, human rights and professional conduct.
Ethics
is a system of moral principles. They affect how people make decisions and lead
their lives. Ethics is concerned with what is good for individuals and society
and is also described as moral philosophy.[1]
Ethics
is a study of what is normally right and what is wrong or a set of belief about
what is morally right and wrong[2].
Morality
is a belief that doing something is good and doing something is bad.[3]
Bio
technology is one of the fastest growing areas of scientific, technical and
industrial innovation of recent times and it is also one of the most prominent
in public discussion especially the ethical issues in relation to it. Ethical
considerations do object to patenting living beings. It is based on the
fundamental principles of natural law which are moral and universal in character.
Natural law stands for integrity, dignity, sustenance, survival and
self-preservation of the values of life.
Hence,
it fosters that every living being is entitled to complete preservation of its
features and should not be disturbed or tampered with. Biotechnology is capable
of removing certain of these features.
ETHICS IN PATENTING BIOTECHNOLOGY:
A US PERSPECTIVE
Even
though moral standards differ from person to person, place to place, patenting
of life is still generally considered as immoral and unethical. Even the US
bill of rights stipulates inherent dignity and intrinsic values of life. It
envisages equal treatment for all and guarantees human dignity.
The
American society is very flexible and changes with the times and situations.
According to the US patent law, anything under the sun made by man in
patentable[4].
No provision speaks of ethics and morality.
The
decision of the US Supreme court in Diamond
v. Ananda M. Chakrabarthy[5],
for the first time raised ethical and moral doubts. The claims were for
micro-organisms capable of eating oil spills. It was initially rejected on the
ground that it was not patentable but since the inventor did not give up, the
SC viewed the invention as non-natural human made invention which did not exist
before. Hence, it was held that patent could be granted on living organisms by
liberally interpreting the language of the US patent law.[6]
The
debates raised as a result of the patent granted became a global one on the
ground that ethical concerns were overlooked. However, by this decision, the US
Patent Office has granted huge number of patents on several micro-organisms.
ETHICS IN PATENTING BIOTECHNOLOGY
INVENTIONS IN THE EUROPEAN UNION AND THE EUROPEAN UNION DIRECTIVE
Ethical
and moral considerations have been given statutory and legal support in the EU.
Existing Patent laws prohibit certain biotechnological inventions on ethical
grounds. The European Patents Convention (EPC) specifically speaks about ethics
in patenting inventions. It states the following:
1. Inventions
which are against public order and morality shall not be patented.
2. Patenting
of plant, animal and essentially biological processes to produce plants and
animals is not allowed.
3. Methods
of treatment of the human or animal body by surgery, therapy and diagnostic
methods are not considered inventions in light of ethical and moral standards
of the society. They are kept away from patent monopolies.
4. Living
things found in nature in the original form are also considered unethical.
The
drive for a comprehensive mechanism on the regulation of bio technology got
accomplished with the adoption of the Directive on biotechnology invention. The
directive came into effect in 2000 and it seeks to address issues of
development in biotechnology as it tries to balance ethics with advancements in
biotechnology like human genetic research, embryo cloning, and stem cell
research.[7]
The
Directive does the following:
1. Evaluates
ethical aspects in biotechnology from time to time.
2. Prohibits
patenting of certain biotechnology inventions on ethical grounds.
3. Reaffirms
the exclusion of plants, animals and essentially biological processes from
patenting.
4. It
excludes the following from patenting on ethical grounds:
a. The
human body at various stages of its formation and development and a simple
discovery of one of its elements including sequence or partial sequence of
gene.
b. Inventions
contrary to public order such as processes for cloning human embryos, processes
for modifying the germ line genetic identity of human beings, human embryos
used for commercial purposes and processes for modifying the genetic identity
of animals that are likely to cause them suffering without any substantial
medical benefit to man or animal and also animals resulting from such
processes.
Comparing
the US ethical standards to EU, it is better formed in EU. Ethics and morality
are being addressed specifically in the Patent laws in the Union and
Directives. Though human cloning is not directly prohibited, certain inventions
in the field of human genetics are excluded on ethical grounds.
ETHICS IN PATENTING BIOTECHNOLOGY
INVENTIONS IN INDIA
India
is a country where theoretically, ethics and morality are respected and adhered
to. They play a vital role in an average Indian. Indian tradition is well known
for worshipping animals and plants like cows, plants like tulsi, neem etc. as
it has been considered gods. For an Indian, patenting these would be like
owning god.
Thus,
it is a sacrilege in India and is not encouraged in the interest of public
order and morality. Private ownership over living and natural things is
prohibited. The Patent Act [8]addresses
ethics in patenting these inventions which oppose ethics. Following the TRIPs
agreement, India brought amendment to its Patent law. It states that any invention, the
exploitation of which is against public order and morality that may cause
serious prejudice to health of Human beings, animals or environment cannot be
patented.[9]
However,
the coming of TRIPs agreement, micro-organisms and such other living inventions
produced by through micro biological or non-biological or biotechnology
processes are now patentable. Thus, it is mandatory for India to grant patent
on inventions through the amendment made to Patent Act of 2005.[10] Till
now, no patent has been granted on living beings like in US AND Europe, so no
serious discussion on ethics and biotechnology issues. These issues might arise
in view of its seriousness over ethics and morality.
A
Patent was granted on a living process on the direction of the Calcutta High
Court. The court held that there was no bar for patenting living beings or
living processes under Patent Act. No ethical or moral issues were involved
therein were considered in this case. The Chief Justice of the Supreme Court of
India says “which promises to mankind the great blessings of science, should
not be stifled by too restrictive approaches.[11]
ETHICS IN PATENTING PLANTS
After
the US court decision in Chakrabarthy case, doubts arose as to extending
protection to multicellular living organisms such as plants and animals. As if
that was not enough, in Exparte Hibberd patent
was granted on a plant. It was the first time where multicellular living
organism was claimed and patented. The claims were to a plant genetically
engineered to possess an abnormally high level of amino acid tryptophan. The US
patent Offices Board of Patents Appeals and Interferences decided a genetically
modified plant as patentable.
The
Board relied on Chakraburthy, placing little emphasis on ethical and social
policies underlying the patenting of plants. The decision attracted severe
criticism and initiated strong debates on the ethics in patenting plants. The
main issue were that plants were a creation of God and human beings could not
own God’s wisdom. Manipulation of pants itself was unethical since it involved
privatizing God’s creation. It disturbed the integrity and right t
self-preservation.
Following
the decision of the Board, many plants were patented, giving little or no
emphasis on the ethics involved therein.[12]
Recently in Pioneer Hibred International
v. JEM AG Supply[13],
the US court of Appeals for the Federal Circuit upheld patents on
engineered plants taking patenting of plants away from ethical and moral
considerations. Hence, it is obvious that in a time not far from now, plants
will be patented without and ethical or moral restrictions.
ETHICS IN PATENTING ANIMALS
Since
animals can express feelings and suffer unlike plants or other living beings,
they are considered as higher life forms. Micro-organisms are known as lower
life forms. The ethical concerns raised here were more serious than in plants
patenting.
In
Exparte Allen[14],
an engineered animal was claimed for possessing an extra set of
chromosomes. The patent was rejected on the ground of obviousness but still, it
opened the gates for patenting animals. The US patent office was of the opinion
that ethics could not prevent the patenting of animals. Shortly after, the
patent office issued a noticed indicating that the US office now considers
non-naturally occurring, non-human multicellular living organisms, including
animals to be patentable.
Since
it has set out its intention[15],
it implies that the US Patent office has decided that ethical and moral
considerations can be undermined. There were of course, stiff oppositions to
this. The Animal League Defence Fund and several Animal and Farmers rights
groups brought suits challenging the US Patent office. They argued that playing
with life of animals was unethical and that it also made animals susceptible to
diseases and causing them to suffer. It was also argued that animals have the
right to preserve integrity and natural characteristics and it is against the
wisdom of God.
On
the other hand, the scientific body argues that the potential benefits through
these manipulations should be considered over and above ethics. They also said
that they are not trying to own God’s creation or wisdom but we are claiming
for non-natural and human made inventions having the potential to benefit the
society at large. More on that, they said they are claiming benefit over their
labour and intellectual effort which is not against ethics.
One
year after this issuance of the notice by the US Patent Office, its first
patent ws granted over a genetically engineered mouse susceptible to cancer in Harvard Oncomouse. The mouse contained a
cancer causing gene inserted by genetic engineering. This was also opposed on
the ground of violation of ethics and animal rights and against public policy
which should not be allowed.
The
view of the patent office on this remained that it benefits humanity and so
should override ethics seeing that cancer was a major disease in the world
suffered by millions of people, and so the testing on the mouse carries hope. Thus,
its potential benefit carries more weightage and so patent was granted.
ETHICS IN PATENTING HUMAN CELL
LINES
It
is obvious that biotechnology is capable of manipulating any living being
including humans. It is capable of isolating, removing, supressing or
incorporating genes from and to the human body. This has also been held to go
against human integrity. According to Ethicists, they say that patenting of human
genetic materials such as DNA, and genes amounts to trespass of a private
property which in turn amounts to slavery and violates human inherent dignity.
Eventually,
patents started being claimed on human genetic materials, giving rise to nerve-
racking and debates on manipulation of human genetic material. In John Moore’s case[16],
a patent was claimed on a cell line of a human being. John Moore was a
leukaemia patient from California, and while treating him, the physicians found
his cell lines useful in preparing a specific medicine and obtained patent on
the same in 1984. This was challenged by John Moore and he argued that the
patented cells were from his body and it was his property and so he had rights
over it and so could own patents over it. Questions were also raised regarding
the morality of patenting a cell line which is a part of the human body since
it struck at the moral roots of humanity.
The
courts rejected Moore’s argument by stating that there could not be any
property rights over one’s body which was against the dignity of human being
and that cell lines were not readily available to be isolated and so a result
of laborious research deserved patent. Further, it claimed that patent was not
claimed on the natural cells from the human body but from isolated cell lines
from outside the body. From this case, the court gave green light for the patenting
of human cells, genes and DNA in an isolated form outside the body, thereby
looking away from the ethical issues.
Again
in 1993, a patent on human cell lines was claimed before the patent office[17].
The cell line was developed from the blood of the patient, a woman which was
found useful in the research of AIDS and cancer. This time, it was not a
private individual that claimed patent but the US Government over the cell
lines of the women from the Guarani Indian tribe of Panama, South America.[18]
This clearly shows that the government of US is in favour of patenting human
cells. There were protests from Non-governmental organisations like Rural
Advancement Foundation International (RAFI) and tribal communities.
The
US government held that patent could be granted since it involved the world’s
most threatening disease AIDS and cancer. In relation to the international oppositions
and criticisms, the Government of America withdrew the patent application.
ETHICS IN HUMAN CLONING
Cloning
of a few other mammals like rabbit, monkey, and cow followed cloning of sheep
raising apprehensions about cloning.[19] The
judiciary became free to extend patent protection starting from micro-organisms
to human genetic material. A patent application was filed in US claiming non
human chimera. Stuart Newman claimed a patent on the invention where he
incorporated a human gene into an animal which resulted in an invention which
was neither animal nor human. The patent officer for the first time, considered
ethical standards and held that the invention could not be patented as it would
outrage public order and morality.
The
Patent office believed that transgenic human beings are not patentable by
virtue of the 13th amendment to the US constitution. Therefore, the
patent was rejected. The Patent office believed that cloning is a general term
that explains the procedure that produces a precise genetic replica of a
biological object including DNA sequence, a cell or an organism. The 13th
prohibits human cloning and patenting of human being. Thus, both the Judiciary
and the Patent office stand on equal footing in viewing that cloning violates
inherent human dignity of human life and patenting of human being amounts to
slavery.
This
implies that inventions relating to transgenic humans are prohibited and so
they both accept the ethical and moral standards of the society which were not
expressly provide in the Patent Law. However, it was further held that
processes or methods of human cloning were patentable. The logic behind
allowing cloning methods to be patentable is still questionable since the
methods still intends to clone a human being.
ETHICS IN HUMAN GENETIC RESEARCH,
HUMAN BODIES AND EMBRYOS IN PURSUIT OF HAPPINESS
Research
in genetics made it possible to produce human organs for the purpose of
transplanting into the body of the needy suffering from organ failures.
Irrespective of ethical objections to cloning, biotechnology is poised to serve
the purpose of the needy. Human genetic research gave rise to research in human
genome, human embryonic research and stem cell research where ethical concerns
were involved.
Human
genomic research involves manipulating with the genetic setup of the individual
which is controversial to ethics. Embryo research involves manipulating of
embryos capable developing into a complete human being. Manipulating the embryo
or foetus at the initial stage is strongly objected. Genetic research further
made it possible to have children through assisted reproduction of infertile
couple. It is even possible to have children with desired characteristics
through assistance of bio technology.
This
came to global recognition and the Declaration on Human Genome and Human rights
convention[20]
came into being. The convention says that
1. Research
in human genome shall respect ethical standards of the society.
2. It
promotes the development of ethical studies in light of scientific and
technological progress in the field of biology and ethics.
3. No
research in these fields should prevail over human rights and dignity.
4. It
recognises freedom of research as a part of freedom of thought.
5. It
encourages research in the field of biology, genetics and medicine to guarantee
right to health and relief from sufferings.
6. It
directs member states to establish ethics committee to assess the legal, and
social issues raised by research on human genome and its application and to
promote education in bio ethics.
7. The
declaration intends to identify practiceses that contradicts human dignity and
ethics in particular such as germ line intervention
8. It
directs member states to come up with legal measure to respect ethics and human
rights.
The
potential in bio technology is having better children, ageless bodies and happy
souls cannot be undermined. During pregnancy, desired features can be
incorporated and unwanted traits removed. Old bodies could be injected with
activeness in order to make them feel younger, eve the mood can be cheered up
with a mood brighter and memory could be improved with memory helper. The
President’s committee on Bioethics submitted its second report in October 2003.
The report did not oppose this manipulation of human body or such pursuits
should be closely monitored; otherwise it may create havoc in society if
everybody goes after it.[21]
ETHICS IN BIO TECHNOLOGY-ASSISTED
REPRODUCTION
Bio
technology is also used in procreating children.[22]
It blesses infertile couple with children through artificial fertilization. In
vitro fertilization and development of human life in vitro (outside mother’s womb)
have generated hope in infertile couple to have children. However, these
technologies used may affect the health of the chid and mother. Also, large
numbers of embryos capable of becoming human beings die and this raises ethical
concerns.
The
President’s committee on Bio ethics says that increased control over the
characteristics of a child may curb natural characteristics. It says that
embryo research affects the dignity of human being and it recommends a study on
the impact of assisted production as there is no law on regulation of assisted
reproduction and use of human embryos.[23]
ETHICS IN STEM CELL RESEARCH
Stem
cells are potent cells capable of developing into any organ in the body. Stem
cells are derived from human embryos living or dead at the stage of four to
eight cells from the time of fertilization and forming of zygote[24]
They
can also be derived from the bone marrow and so they are created artificially
through IVF or through embryo cloning.[25]
It helps in producing tissues that are useful for organ transplant, cure to
diseases and as models to understand how certain diseases are developed. It is
also useful in drug development and treating patients suffering from diabetes,
Parkinson’s Alzheimer’s disease, spinal cord injury and heart ailments.[26]
In order to do all of these, tissues produced through stem cell research are
ought to be used. This gives rise to serious ethical concerns as stem cells are
capable of developing into a human being and embryo is the initial stage of a
human being. Ethics opine that destruction of embryos is nothing but causing
death of a prospective human being.
The
ethical objects are that;
1. We
cannot end some lives for the sake of bio medical research.
2. Stem
cell research is nothing but commodification of human embryos where the moral
status is not determined prior to the research.
3. Ethics
Advisory Board of the Geron Corporation says that moral status of embryos needs
to be determined before research should be carried out.
4. The
American Association for the Advancement of Science (AAAS) states that
disagreement on the status of embryo is a burning point in solving ethical
issues.
5. The
National Bioethics Advisory Committee (NABC) describes the ethical issues
raised as principally related to current sources and or methods of deriving
stem cells and that it deprives a human embryo to develop into a complete human
being.
However,
the National Institute of Health (NIH), a federally funded agency through its
Human Embryonic Research Panel (HERP) states that isolation of human embryonic
stem cells is an area of research that might yield significant scientific
benefit but that with controversies over stem cells research and status of the
embryo, the Bush administration issued some NIH guidelines over stem cell
research.
The
guidelines say the following:
1. That
federal funding should be given to research in stem cells derived from embryo
which no longer has the possibility of development into human being.
2. Informed
consent for donation without any financial inducement must be obtained for
donation of any embryo.
3. Stem
cells could be derived from dead embryos but there is no specific measure to
decide the death of an embryo.
The
solution however does not rest in whether the government funds it or not,
because with or without the funding, research will go, but, certain measures
should be developed to regulate stem cell research with respect to ethical
concerns.
The
deliberate creation a defective, sick or disabled embryo by tampering with
human genome and putting something destructive is ethically not acceptable and
so highly criticised. This is because women can be forcibly made to donate eggs
which break ethical boundaries. One of the professors from the University of
Pittsburg has forcefully collected eggs to use in research involuntarily
against the principles of morality set under the NIH guidelines even though the
professor claims to have produced cloned human embryos.
As
a result of so much controversy, the federal states have enacted separate laws
to regulate stem cells by saying that in
vitro fertilized embryo can only be used before the 14th day of
conception and before embryo is implanted into the mother’s womb. They also
said that irrespective of the nature of fertilization, once it is 14 days old,
no stem cells can be derived. A few states have also ban in vitro
fertilization for creating embryos to derive stem cells. In the absence of
uniformity in stand, there is an urgent need to enact federal laws to balance
biotechnology for the interest of ethical values.
TRIPs AGREEMENT AND ETHICS
With
the coming of TRIPs, ethics, morality and public order form a restriction to
the patentability of inventions. It says that inventions which are against
public order or morality can be excluded from the purview of patentability. It
further states that inventions which can be detrimental to the health of human,
animals, plants or environment may also be excluded.[27]
Thus,
TRIPs excludes natural plants, animals, and essentially biological processes
form patentability. People who argue against life patenting says that TRIPs
refuse these on ethical grounds while others who have no problems with it are
of the opinion that though TRIPs agreement prohibits the organisms of natural
origin but does not prohibit non-natural human made or genetically engineered
plant, animal and isolated and purified human genetic material in non-natural
forms.
In
US, when a major upsurge in the 1990’s led to a rise in the number of patents
granted on human genetic material such as DNA and genes, ethical boundaries
were undoubtedly crossed and there was a plethora of patent applications
claiming human genetic material. Examples are In Amgen v. Chugai[28]
where the claim was for DNA, in re
Bell[29]
also for DNA, in re Duel[30],
the invention related to an isolated and purified DNA, in re Farell[31],
the invention was a method to produce a foreign protein transformed species
of bacteria.
Research
methodology and genetics took an interesting dimension as the entire world was
shocked with the news of the birth of Dolly, the cloned sheep in 1997. Dolly
was a clone of a six year old sheep which resembles its predecessor. Dolly
raised debates over the ethics that were hampered with biotechnology. Doubts
and fears abound humans might as well be cloned in the coming times.
HUMAN RIGHT CONVENTIONS AND ETHICS
Clearly,
it seems that the EPO considered the potential benefits of biotechnology
inventions above ethics as a case study. Despite huge protest, patenting of micro-organisms
to patenting of human genetic materials is on the increase. Fears have arisen
that this may lead to patenting of human beings, hence, the mandates of the
European Convention for the protection of Human Rights and Fundamental freedoms
are significant.
The
convention stands in line with the Universal Declaration of Human Rights and
such other human rights conventions for the protection of the inherent dignity
of human beings. Patents in violation of human dignity and freedom are
considered unethical under the convention. The convention intends to:
a. Guarantee
human rights
b. Human
rights dignity vis-à-vis developments
in the field of biotechnology.
United
Nations Declaration on Human Genome and Human Rights says that:
a. Research
in human genome shall respect ethical standards of the society.
b. Shall
promote the development of ethical studies in view of scientific and
technological progress in the field of biology and genetics[32].
c. That
no research in the fields of biology and medicine should prevail over the
respect for human rights and human dignity.[33]
d. Recognises
freedom of thought and research in the field of biology, genetics and medicine
as a necessary means to guarantee right to health and relief from sufferings to
the mankind.[34]
e. The
Declaration directs member states establish ethics committee to be able to
access the ethical, legal and social issues raised by research in human genome
and its applications.[35]
f. The
Ethics committees established are to take initiative to promote education in
bioethics.
g. The
Declaration intends to identify the practices that could be contrary to human
dignity and ethics and human rights in the light of advancement in the field of
human genetic research such as germ line intervention.[36]
h. It
also mandates member states to come with proper legal measures to respect
ethics and human rights in the light of these advancements.
CONVENTION ON HUMAN RIGHTS AND BIO
MEDICINE
The
EU adopted a Convention on Human Rights and Bio medicine[37].
The convention intends to protect human dignity in respect of human beings and
the subject matter of research is biomedical sciences.
The
research says the following:
a. That
research in human beings, tissue, organs or human genome shall be undertaken
only after informed consent of the person concerned after disclosing possible
risks associated.[38]
b. That
the interest and welfare of the human being shall prevail over the sole
interest of the society or science.[39]
c. Using
of human body and its parts for financial gain is prohibited.[40]
d. To
provide adequate protection for human embryos from misuse.[41]
e. It
encourages the debates over the ethics in the development of biomedical field.[42]
ETHICS GROUPS AND COMMITTEES IN UK
In
the EU, there are established groups to advice on the ethics in the latest
developments in biomedical research. They strive to investigate on the ethical
implications of biomedical research.
The
European group on Ethics and in Science and Technologies states that human
dignity and integrity shall be ensured while using human tissues in biomedical
and genetic research.[43]
The group of advisors on the ethical implications of biotechnology opines that
no patent should be granted on the human body at different stages of its
constitution and developments or on its element.
The
both groups also recommend guaranteeing of human dignity in the light of
developments in the biomedical research. The research in human genetics,
especially on the human body shall be conducted only for therapeutic purpose
and after obtaining informed consent of the person concerned.
Different
committees in the UK have been established to address and advice on biomedical
and human genetic research. They are s follows:
1. THE
NULLIFIED COUNCIL ON BIOETHICS which states that there shall be generic debate
on human genetics and use of human tissues in biomedical research.[44]
2. THE
HUMAN GENETIC ADVISORY COMMITTEE (HBAC)[45]
established with the sole aim of addressing the ethics involved in research in
human genetics. It also reviews the progress in the research and reports on the
wider social, ethical and economic consequences of such developments.
3. THE
ADVISORY COMMITTEE ON GENETIC TESTING (ACGT) advises on the ethics in the
genetic testing of human beings, foetus, and embryos.
4. THE
GENE THERAPY ADVISORY COMMITTEE (GTAC) advises on the ethics associated with
removal, suppression, and incorporation of genes from and to the human body
through gene therapy in order to curb genetic diseases.
NB:
Both the ACGT and the GTAC represent and take the assistance of HBAC in
advising the Government of UK on such ethical issues.
5. THE
HUMAN FERTILIZATION AND EMBRYOLOGY AUTHORITY was established under the Human
Fertilization and Embryology Act to monitor the working of fertility clinics in
helping parents have children and to
regulate assisted reproduction. It also regulates human embryo research.
ETHICS COMMITTEES IN THE US
The
Government of US did set up a committee National Bioethics Advisory Commission
in 1997. Its Primary job was to report on the ethics involved in research in
biology and medicine especially related to human genome and human cloning.
Its
first report was related to cloning and it called for further consideration of
the ethical and social questions raised. Another report was submitted by the
National Academy of Sciences (NAS) on the same subject. The both reports
concluded that attempts to clone human being would be unethical.
Another
committee was setup by the government of America to advise on bioethical issues
related to advances in biomedical science and technology. In the committee’s
first report submitted in Jul 2002, prohibition of human cloning was
recommended which later led to the passing of Human Cloning Prohibition Act,
2003.
The
Act defines cloning to mean asexual reproduction, that is a reproduction not
initiated by the union of egg and sperm and accomplished by introducing nuclear
material from one or more human somatic cells into a fertilised or unfertilised
oocyte whose nuclear material has been removed or inactivated so as to produce
a living organism at any stage of development that is generally virtually
identical to an existing or previously existing human organism.[46]
The
Act distinguishes reproductive cloning from therapeutic cloning and so it
prohibits reproductive cloning on ethical grounds, it only allows for
therapeutic cloning. Human cloning or an attempt to do so is punishable with 10
years’ imprisonment or a fine upto $1, 000, 000.
ICMR GUIDELINES ON ETHICS IN HUMAN
GENETICS
Though
not many patents are granted on living beings in India, the Indian Council of
Medical Research issued guidelines to evaluate the ethics involved in human
genetics such as human genome mapping, genetic recombinant engineering,
assisted reproduction technology, stem cell research involving serious ethical
questions the guidelines are very
significant.
The
present guidelines acknowledge international conventions on human rights and
fundamental freedoms. Respect is also shown towards international ethical
guidelines for biomedical research involving human subjects by the Council for
International Organizations of Medical Science (CIOM) in 1993 and general
principles of World Medical Association issued in 1994. The Helsinki
declaration[47]
The
guideline states the following:
a. That
research on human subject shall be done only after the consent (voluntary
participation) after explaining to the subject the risks.
b. It
protects participants from physical or psychological harm or risk.
c. It
states that the institutional ethical committees established with necessary
expertise for the purpose should scrutinize research proposals on human
genetics.
d. It
intends to establish Central Ethics Committee (CEC) and National Bioethics
Committee (NBC) to take initiative in organising debate on ethics in human
genetics.
e. It
prohibits misuse of results of human genetic research against ethical standards
such as for identification of sex of the child or to enhance capacity of the
child, etc.
However,
the practise of gene therapy to cure genetic diseases is allowed under the
guidelines subject to the approval of National Bioethics Committee, but then,
the use of this genetic research to enhance genetic characteristics like
intelligence and memory is considered unethical.
It
does not consider assisted reproduction as unethical nor does it consider in vitro fertilisation. But creating and
using embryo and foetus as for commercial purposes is considered unethical and
so prohibited. Using of embryos above 14days is also considered unethical and
encouraging abortions for research purpose is also prohibited. Using of foetal
tissue for the purpose of organ transplantation is not considered unethical
provided the issue is obtained from a dead embryo and ethics committee approves
the same. The guidelines say that removal of tissue from embryo is unethical if
it hurts the development of a child. Thus, while obtaining tissue from a
foetus, the overall development of the foetus and mother should be taken care
of.
The
Patent Act in India is in line with TRIPs agreement and both do not speak
explicitly on the serious ethical grounds. The TRIPs agreement allows its
members to give its own exclusions on the patentable inventions on the grounds
of ethics and morality.
INTERNATIONAL BIOETHICS COMMITTEE
There
is a global forum to discuss and evaluate ethics in biotechnology namely the
Global Forum on Bioethics in Research[48]
which came into being in 1983. The forum works under the auspices of the
UNESCO.
It
is an informal partnership established by a number of organizations with a
shared interest in ethics in conducting research involving human beings in
developing countries.
The
forum provides for a universal platform to debate on ethics involved research
in biotechnology and life sciences. The forum first met in 1999 and seven times
thereafter to evolve an international consensus on bioethics in view of
developments in life sciences and biotechnology. The last meeting was held
between 17 and 19 February 2006.It intends to:
a. Promote
reflection on the ethical and legal issues raised by research in life sciences.
b. Encourage
awareness and make recommendations on bioethics.
c. Cooperate
with International governmental and non-governmental organisations as well as
national and regional bio ethics committees concerning bioethics.
CONCLUSION
The
benefits of biotechnology cannot be ruled out by anyone but there lacks
uniformity of understanding over ethical issues. Such tampering of life may
prove beneficial to the society but it is at the cost of ethics and morality.
Everything that comes from biotechnology are not acceptable but many are
inevitable.
We
have already sacrificed ethics to a certain extent in allowing the manipulation
of micro-organism, plants and animals. There should be some limit to
everything. A balancing approach should be followed to respect ethical concerns
and at the same time encourage biotechnology.
There
should also be uniformity of understanding and platform should be set to
assess, evaluate and respect these moral standards. Ethical line should not
undermine the potential benefits of biotechnology in the interest of the
society.
BIBLIOGRAPHY
TEXTBOOKS
a. Albert
Bruce, Bray Dennis, Lewis, Julian, Raff, Martin, Roberts, Keiths, and Watson,
James D, Molecular Biology of the Cell, Third
Edition, New York, Graland
Publishing, York, 1994.
b. Bachhwat.
B.K. Biotechnology: A Perspective –
Growth of Bio Technology in India: A Tribute to Dr. S. Ramachandra , New
Delhi : Narosa Publishing House, 1992.
c. Bently,
Lionel and Spyros M. Maniatis, Intellectual
Property and Ethics, London: Sweet and Maxwell, 1998.
d. Brier,
Crespi and Straus, Biotechnology and
Patent Protection, Paris, OECD, 1985.
e. Bull,
Holt, and Lilly, Biotechnology,
International Trends and Perspectives, Paris: OECD, 1982.
f. Cornish
W.R, Cases and Materials on Intellectual
Property, London: Cavendish Publishing Ltd., 1999.
g. Finnies,
John, Natural Law and Natural Rights, Oxford:
Clarendon Press, 1986.
LIST OF INTERNATIONAL CONVENTIONS
a. The
International Convention for Cultural and Economic Rights (ICCER), 1966.
b. The
European Convention for the Protecction of Human Rights and Dignity of the
Human Being with Regard to the application of Biology and Medicine (Convention
on Human Right and Bio-medicine)
c. The
Universal Declaration of Human Rights (UDHR), 1948.
d. The
Trade Related Aspects of Intellectual Property Rights, 1994.
e. Universal
Declaration on the Human Genome and Human Rights, 1997.
LIST OF REPORTS
a. WIPO
Study on the protection of Inventions in the field of Biotechnology,
WIPO/Cornell University, 1987.
b. Report
of the Nullified Council on Bioethics, London, 1993, 1995 and 1996.
c. Human
Cloning and Human Dignity: An Ethical Enquiry, Report of the Presidents Council
on Bioethics, Washington D.C, July, 2002.
d. Beyond
therapy, Biotechnology and Pursuit of happiness, A report of the Presidents
Council on Bioethics, Washington DC October, 2003.
LIST OF LEGISLATIONS
a. The
United States Patent Act.
b. The
Embryology and Fertility Act of UK.
c. The
Human Cloning Prohibition Act, 2003.
d. The
Patents Act of UK, 1977.
e. The
Human Fertilization and Embryology Act of UK, 1990.
f. The
DNA safety guidelines, 1994.
g. The
Patents Act of India 2002 and 2005.
[1]BBC online Dictionary, BBC Press,
Ethics-a general Introduction, available
at http://www.bbc.co.uk/ethics/introduction/intro_1.shtml, Last seen on 19/04/2017.
[2]
Canbridge
Dictionary of American Engliah, Cambridge
University Press, Cambridge, United Kingdom, 2000.
[3]
H.L.A. Hart, Law, Liberty and Morality, oxford University Press, New
Haven, 1921, p. 104.
[4]
The opinion of the judges
in Diamond v. Ananda M. Chakraburthy (447
US 303 (1980) while interpreting the patent law of America in order to grant
patent on living organism for the first time in history.
[6]
Manu Luv Shahalia, Intellectual Property Rights:Many Sides to a
coin, Universal Law Publishing Company, New Delhi, 2003.
[7]
See Supra note 16.
[9]
Section 3b.
[10]
India was given 10 years
transmission period to modify its Intellectual property laws to bring in
conformity with the provisions of the TRIPs agreement. The period ended by 1
January 2005 and from the same date, India has been accepting applications
claiming different living beings produced through biotechnology.
[11]
Foreward to the Indian
Council of Medical Research (ICMR) guidelines, 2000.
[12]Jayashree Watal, Intellectual Property Rightsin the WTO and
Developing Countries, Oxford University Press, New Delhi, First published
in India, Third impression 2002, p.152.
[13] World Intellectual Property
Report, Vol. 14, No. 3, 15 March 2000.
[14]
1987 2 USPQ 2d 1425.
[15]
Patricia A. Rac, Patentability of Living Subject matter,10,
CIPR 41 (1993).
[16]
Supreme Court of
California, 9 July 1990.
[17]
Patent application No.
9208784 A 1, 1993.
[18]
Rajiv Jain and Rakesh
Biswas Law of Patents: Procedure and
Practice, Vidhi Publishing Co. (P) Ltd. New Delhi Second Edition, 1999,
p.136.
[19]
Cloning is the process of
producing identical organisms through the division of a single embryo or
through nuclear transfer or replacement of a nucleus in an egg by a foreign
nucleus. It is a method of reproduction involving the copying of a cell or an individual
from its DNA. See Damayanthi and Anila v. Menon, Ethical and Legal Implications
of Human cloning, The ICFAI journal of
Health and Law, Volume II, No. 2, May 2004, p. 65.
[20]
United Nations Universal
Convention on Human Genome and Human Rights, 1997.
[21]Dr. Sreenivasulu, N.S. and Dr.
Raju, C.B, Biotechnology, 14
December, 2007.
[22]Reproduction and Responsibility:
The regulllation of new biotechnologies, A report of the President’s Committee on Bioethics submitted in March
2004, pp. 23-88, 174-177.
[23]
The committee intend to
strengthen the fertility Clinic Success Rate and Certification Act, 1992, to
regulate assisted reproduction.
[25]
Monitoring Stem Cell
Research, report by the President’s Committee on Bio ethics submitted in
January 2004, pp. 30-48, 74-97.
[26]
Stem cell technology can
help cure heart ailments, The Hindu, 13
March 2006, p.3.
[27]
The TRIPs Agreement,
Article 27(2) and (3). However, patenting of surgical, therapeutic and
diagnostic method for the treatment of plants are considered not to go against
the standards of the society.
[28]
927 F.2d 1200, 18 USPQ 2d
1016 (Fed. Cir, 1991).
[29]
991, F2d 781 (Fed. Cir.
1993)
[30]
51 F. 3d1552 (Fed. Cir.
1995)
[31] 853 F. 2d 894 (Fed. Cir. 1988).
[32] Preamble of the Declaration.
[33] Article 10 of the Declaration.
[34] Article 20 of the Declaration.
[35] Article 16 of the Declaration.
[36] Article 26 of the Declaration.
[37]
The Convention for the
protection of Human Rights and Dignity of the Human being with regard to the
application of Biology and medicine.
[38] Article 13 on the Human genomes.
[40] Article 2, Privacy of the human
being.
[41]
Article 18 : Research on
embryo in vitro
[42] Chapter X, Article 28 : Public
debate. See Colin Camphell, A commission
for the 21st century, Modern Law Review, p. 598.
[43] See the opinion of the European
group on Ethics in Science and Technology rendered to the European Commission
21 July, 1998.
[44] Modern Law Review, 1998, p. 594.
[45] HBAC, a non-statutory body was
established in December 1996.
[48] www.gfbroonline.com
Comments
Post a Comment