3. Ethics in Human geneticResearch, Human bodies andembryos
Ethics in assisted reproduction
Ethics in StemCell research
TRIPs agreement and Bioethics
Human Right convention and Ethics
Convention on Human Right and Bio medicine
Ethic Groups and committee andin UK
Ethic groups and committee in US
ICMR Guidelines in India
International Bio Ethics Committee
Conclusion
4. INTRDUCTION TO ETHICS
Ethically speaking, livingbeings are creationsof God, whichcannot be owned
byhumanbeingsthroughpatents.
Living beings are vested with an inherent dignity and integrity which is
protectedandguaranteed
Human beings cannot also play with the wisdom of God by manipulating
livingbeingssincethismanipulationhitsonhumanintegrityanddignity.
Genetic manipulation of organisms and its protection by patent system has
alwaysraisedanissueandcryonmoralandethicalissues.
5. WHAT IS ETHICS AND MORALITY
The term is derived from the Greek word ethos which can mean custom, habit,
characterordisposition.
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.
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.
Morality is a belief that doing something is good anddoing something is bad.
6. ETHICS ANDPATENTING IN US
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
envisagesequaltreatment forallandguaranteeshumandignity.
The decision of the US Supreme court in Diamond v. Ananda M.
Chakrabarthy.
It 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
patentsonseveralmicro-organisms.
7. ETHICS ANDPATENTING IN INDIA
India is a countrywheretheoretically, ethics and morality arerespected and adhered to.
Indian tradition is well known for worshipping animals and plants like cows, plants like tulsi, neem etc. as it has
been considered gods. For anIndian, patenting thesewould be likeowning god.
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.
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 amendmentmadeto Patent Act of 2005
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.
8. ETHICS ANDPATENTING IN UK
Ethical and moral considerations have been given statutory and legal support in the EU. Existing Patent laws prohibit certain biotechnological
inventionsonethicalgrounds.
EuropeanPatentsConvention(EPC) specificallyspeaksaboutethicsinpatentinginventions.Itstatestheff:
a. Inventions which are against public order and morality shall not be patented.
b. Patenting of plant, animal and essentially biological processes to produce plants and animals is not
allowed.
c. 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.
d. 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
ethicswithadvancementsinbiotechnologylikehumangeneticresearch,embryocloning,andstemcellresearch.
ItDoesthefollowing:
1. Evaluates
2. Reaffirms
3. Excludes
4. Prohibits.
9. ETHICS IN PATENTING PLANTS
After the US court decision in Chakrabarthy case, doubts arose as to extending protection to
multicellularlivingorganismssuchasplantsand animals.
in ExparteHibberdcase patent was granted on a plant. Itwas thefirst time where multicellular living
organism was claimed and patented. The claims were toa plant genetically engineered to possess an
abnormally high level of amino acid tryptophan. The US patent Offices Board of Patents Appeals
andInterferencesdecidedageneticallymodifiedplantaspatentable.
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.
manyplantswerepatented,givinglittleorno emphasison theethicsinvolvedtherein.
Recently in Pioneer Hibred International v. JEM AG Supply, the US court of Appeals for the Federal
Circuit upheld patents on engineered plants taking patenting of plants away from ethical and moral
considerationsWorldIntellectualPropertyReport,Vol.14, No.3,15March2000.
Soon,PatentingofLifeplantsmaybenextin line!
10. ETHICS INPATENTING 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
concernsraisedhereweremore seriousthaninplantspatenting.
In Exparte Allen, 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
gatesforpatentinganimals19872 USPQ2d 1425.
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
animalstobe patentable.
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
andit isagainstthe wisdomof 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
theyareclaiming benefitovertheirlabourandintellectualeffort whichisnot againstethics.
Onco MouseCase-decidedit was beneficialfor cancer..
11. ETHICSAND PATENTINGIN CELLLINES
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.
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. He had leukamia and he was 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. He sued for this, sayig that the
cell was gotten from his body. The court held that cell lines were not readily
available to be isolated and so a result of laborious research deserved patent.
that patent was not claimed on the natural cells from the human body but from
isolated cell lines from outside the body.
This marked the beginning of patenting cell lines buyt there are certain restrictions
put to it.
12. Later, another case a patent on human cell lines was claimed before
the patent office. The cell line was developed from the blood of the
patient, a woman which was found useful in the research of AIDS
and cancer Patent application No. 9208784 A 1, 1993.
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.
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.
13. ETHICS IN HUMAN CLONING
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 judiciary became free to extend patent protection starting
from micro-organisms to human genetic material.
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.
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.
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.
14. ETHICS INHUMAN REASEARCH, HUMANBODIES ANDEMBRYOS
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 capabledeveloping into a complete human being. Manipulating the embryo or foetusatthe
initial stage is strongly objected.
This came toglobal recognition andthe Declaration on Human Genome andHuman rights convention came intobeing. The
convention says that Research shall
A. Respectethicalstandards
B. Promotedevelopmentofethicalstudies.
C. Researchshould notprevailoverhumandignity.
D. Recognisedfreedomofresearchaspartoffreedomofthought.
E. DirectsmemberstatestoestablishEthics committeesandcomeup withlegalmeasures
F. Identifiespracticeswhichcontradicthumandignity
The President later formed a committee which submitted a report saying that they did not oppose this manipulation of human body or
such pursuits should beclosely monitored; otherwise itmaycreate havoc in society ifeverybody goes after it.
15. ETHICS INASSISTED REPRODUCTION
Biotechnology is alsoused in procreating children.
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 andthis 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 anduse ofhuman embryos.
16. 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.
They can also be derived from the bone marrow and so they are created artificially through IVF
or through embryo cloning.
It is used to cure 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.
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.
Ethics Advisory Board of the Geron Corporation, The American Association for the
Advancement of Science (AAAS) and 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.
17. The Guidelines were:
a. Federal funding
b. InformedConsent
c. Derived fromdeadembryosbutthereisnospecific measuretodecide thedeathofanembryo.
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
toethical concerns.
One major issue is intentionally creating a deformed embryo for the purpose of research or even collecting
embryosbyforce.Forexample:
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
haveproducedcloned humanembryos.
As aresult ofso muchcontroversy,thefederalstateshaveenactedseparatelaws toregulatestem cells by saying
thatinvitrofertilizedembryocanonlybeusedbeforethe14th dayofconceptionandbeforeembryoisimplanted
intothemother’swomb.Theyalsosaidthatirrespectiveofthenatureoffertilization,onceitis14daysold,no
stemcellscanbederived.
18. TRIPs AGREEMENT AND ETHICS
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.
TRIPs excludes natural plants, animals, and essentially biological processes form patentability.
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 like in Amgen v. Chugai where the claim was for DNA, in re Bell also for DNA,
in re Duel, the invention related to an isolated and purified DNA, in re Farell, the invention was a method to
produce a foreign protein transformed species of bacteria.
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.
19. ETHIC GROUPS INUK
In the EU, there are established groups to advice on the ethics in the latest developments in biomedical research. They
strive to investigate onthe ethical implications of biomedical research.
Thegroups ensure the ff:
a. Human dignity is ensured.
b. No grant of patent on humanbody per se
c. Integrityin biomedical research
• SuchCommittees are :
a. THE NULLIFIED COUNCIL ON BIOETHICS which states that there shall be generic debate on human genetics and use of
humantissues in biomedical research.
b. THE HUMAN GENETIC ADVISORY COMMITTEE (HBAC) established with the sole aim of addressing the ethics involved
in research in human genetics HBAC, a non-statutory body was established in December 1996. It also reviews progress of
research.
c. THEADVISORY COMMITTEEON GENETIC TESTING (ACGT) advises on the ethics in the genetic testing of human beings,
foetus, and embryos.
d. 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. Italso regulates humanembryoresearch.
20. ETHICS COMMITTEE 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
inbiologyandmedicineespeciallyrelatedtohumangenomeandhumancloning.
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
whichlaterledtothepassingofHumanCloningProhibitionAct,2003.
21. ETHICS COMITTEES IN INDIA-ICMR GUIDELINES..
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
ethicalquestions.
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
generalprinciplesof WorldMedical Associationissuedin1994.TheHelsinkideclaration.
Theguidelinesareasfollows:
a. Researchshallbe donewithpriorconsentofsubjectobtainedvoluntarilyafterexplainingtherisksinvolved.
b. Participantsmustbe protectedfromphysicalandpsychologicalharm
c. Establishesethical committeestoscrutinizeresearchproposalsanditsadvancement.
d. It intends to establish Central Ethics Committee (CEC) and National Bioethics Committee (NBC) to take initiative in organising debate on ethics in
humangenetics.
e. 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.
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
researchtoenhancegeneticcharacteristicslikeintelligenceandmemoryisconsideredunethical.
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. 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.
22. INTERNATIONAL BIOETHICS COMMITTEE
There is a global forum to discuss and evaluate ethics in biotechnology
namely the Global Forum on Bioethics in Research which came into being in
1983. The forum works under the auspices of the UNESCO.
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.
Its Agenda includes:
a. Promote debate on ethical and legal issues raised.
b. Encourage awareness.
c. Cooperate with International governmental and non-governmental
organisations as well as national and regional bio ethics committees
concerning bioethics.
The EPO AND The Convention on Human Rights and Bio medicine supports
the same and even more.
23. 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.
There should be some limit to everything. A balancing
approach should be followed to respect ethical concerns and at
the same time encourage biotechnology.
Ethical line should not undermine the potential benefits of
biotechnology in the interest of the society.
BENITA EZEIGBO..
