ANSWER SCRIPT

HEALTH LAW

NAME- SUFIYAN SIDIDIQUI

YEAR- 4TH YEAR (8TH SEMESTER)
REGULAR BATCH
ROLL NO- 56
EXAMINATION ROLL NO.- 16BLW049
ENROLL NO- 16-5167
B.A. LL.B. (H) SEMESTER- VIII EXAMINATION 2020

HEALTH LAW

Maximum Marks: 75

Note: 1. Answer all questions.

2. All questions carry equal marks.
3. Each answer shall be approximately of 1500 words.
4. The answers may be typed or hand-written and scanned.
5. Mention your Name, Roll No. and Regular/Self-Finance at the beginning of
your answer document.
6. All answers shall be in ONE document and the document shall be e-mailed
as an attachment to ssarkar@jmi.ac.in.
7. The subject-line of the e-mail shall be “HEALTH LAW EXAMINATION”
8. Last date of submission of the answer script is May 29, 2020.

……………………………………………………………………………………

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Q. 1. Evaluate the protection of right to health and healthcare in India with
reference to national and international legal instruments and court judgments.

ANSWER 1:

Health means a state of complete emotional and physical well being. In the year 1946, the
preamble to the Constitution of WHO (also known as ‘Magna Carta’ of health) defined health
as “a state of complete physical, mental and social wellbeing and not merely the absence of
disease”. From the definition itself, it is clearly indicated that condition of life of the
individual should incorporate physical, mental & social well being & must be devoid of
disease & infirmity. This is why it is more accurate to describe it as the right to the highest
attainable standard of physical and mental health, rather than an unconditional right to be
healthy. Health care is a broad notion embracing health services in relation to disease
prevention, health promotion, therapeutic services and rehabilitation.

❖ COMPONENTS OF RIGHT TO HEALTHCARE:

1. Availability: Adequate healthcare infrastructure (hospitals), goods (medicines) and

services (doctors etc) must be available in all geographical areas and to all.
2. Accessibility: Health care must be universal and protect everyone’s health on an equitable
basis. Facilities, goods and services must be affordable and comprehensive for all.
3. Acceptability: The facilities, goods and services should also respect medical ethics, and be
gender-sensitive and culturally appropriate. In other words, they should be medically and
culturally acceptable.
4. Good Quality: They must be scientifically and medically appropriate and of good quality.
This requires, trained health professionals, scientifically approved and unexpired drugs and
hospital equipment, adequate sanitation and safe drinking water.

In India, the right to health care and protection has been recognized, since early times,
Independent India approached the public as the right holder and the state as the duty-bound
primary provider of health for all. India being a founder member of the United Nations, has
ratified various international conventions promising to secure health care right of individuals
in society. Indian Constitution does not expressly recognize the fundamental right to health.
However, Article 21 of the Constitution of India guarantees a fundamental right to life &

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personal liberty which should be read harmoniously with Articles 38, 42, 43, & 47 to
understand the nature of the obligation of the state for its effective realization.

FUNDAMENTAL RIGHTS-

• Article 21 guarantees right to life and personal liberty. The right to live means
something more, than more animal existence & includes the right to life consistently
with human dignity & decency.
• Article 23(1) prohibits traffic in human beings. It is well known that traffic in women
leads to prostitution, which is turn is to major factor in spread of AIDS.
• Article 24 is relating to child labour it states that no child below the age of 14 years
shall be employed to work in any hazardous employment.

DPSP AND HEALTH-

Part IV of the Indian Constitution which is DPSP imposed duty on states.

• Articles 38 impose liability on state that state secure a social order for the promotion of
welfare of the people but without public health we can’t achieve it.
• Article 39(e) related with workers to protect their health.
• Article 41 imposed duty on state to public assistance basically for those who are sick &
disable.
• Article 42 it’s a primary responsibility of the state to protect the health of infant and
mother by maternity benefit.
• Article 47 spells out the duty of the state to raise the level of nutrition & the standard of
living of its people as primary responsibility. Some other provisions relating to health fall
in DPSP.

JUDICIARY’S TAKE ON THE RIGHT TO HEALTH

In Municipal Council, Ratlam vs. Vardhichand & Ors, the municipal corporation was
prosecuted by some citizens for not clearing up the garbage. The corporation took up the plea
that it did not have money. While rejecting the plea, the apex court held that public health is a
state priority, and further the Court through Justice Krishna Iyer observed: “The State will
realize that Article 47 makes it a paramount principle of governance that steps are taken for
the improvement of public health as amongst its primary duties.”

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In Paschim Banga Khet Mazdoor Samity v. State of West Bengal, it was held that that
Article 21 imposes an obligation on the State to safeguard the right to life of every person.
Preservation of human life is thus of paramount importance. The government hospitals run by
the State and the medical officers employed therein are duty-bound to extend medical
assistance for preserving human life.

In Consumer Education and Resource Centre v. Union of India, the Supreme Court has
held that the right to health and Medical care is a fundamental right under Article 21 of the
constitution as it is essential for making the life of the workman meaningful and purposeful
with dignity of person. “Right to life” in Article 21 includes protection of the health and
strength of the worker. The expression ‘life’ in Article 21 does not connote mere animal
existence. It has a much wider meaning which includes right to livelihood, better standard of
life, hygienic conditions on workplace and leisure.

In Parmananda Katara v. Union of India, it has been held that held that it is the professional
obligation of all doctors, whether government or private, to extend medical aid to the injured
immediately to preserve life without waiting legal formalities to be complied with by the
police under Cr.P.C. Article 21 of the Constitution casts the obligation on the State to
preserve life.

INDIAN LEGISLATIONS AND THE RIGHT TO HEALTH

• Indian Penal Code: Section 92 of the Code exempts a person from any harm caused
to a person for the act done in good faith for benefit of a person without consent.
Section 269 punishes any person who unlawfully or negligently does any act which
is, and which he knows or has a reason to believe to be, likely to spread the infection
of any disease dangerous to life.
• Environment (Protection) Act,1986: The Biomedical Waste (Management and
Handling) Rules, 1998 and The Biomedical Waste (Management and Handling)
Amendments Rules, 2000 were notified by the Central Government in exercise of the
powers conferred by Ss 6, 8 and 25 of the Environment (Protection) Act, 1986, which
makes it a duty of every occupier of an institution generating biomedical waste to
ensure that such waste is handled without any adverse effect to human health and the
environment.

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 • The Drugs and Cosmetics Act, 1940: Section 10 of the said act prohibits the
manufacture, sale, distribution of drugs and cosmetics which are not of a standard
quality or misbranded or adulterated or spurious and which are injurious to health.
• The Epidemic Diseases Act, 1897: The Act was passed to provide for the better
prevention of the spread of Dangerous Epidemic Diseases. Section 2 of the said act
concerns special measures for control of epidemic diseases.
• The Transplantation of Human Organs Act, 1994: Section 9(1) of the act restricts
live donation and transplantation into a recipient unless the donor is a near relative of
the recipient.
• The Maternity Benefit Act, 1961: Section 5 of the Act defines the right to payment
of maternity benefits for which a woman is entitled. The Act also provides for the
leave for miscarriage up to six weeks with pay immediately following the day of her
miscarriage or medical termination of pregnancy.
• The Prevention of Food Adulteration Act, 1954: Section 5 of the act prohibits
manufacture, sale, storage, distribution and import into India any adulterated,
misbranded, any article for the import of which a license is needed and any article of
food which is in contravention to any other provision of this Act.

INTERNATIONAL INSTRUMENTS VIS-À-VIS CONCEPT OF HEALTH:

• The Universal Declaration of Human Rights: Article 25 lays down that states must
ensure that all citizens enjoy an adequate standard of living. It recognizes food,
clothing, housing, health care and social services as essential components of a
standard of living adequate for health and well-being.
• The International Covenant on Civil and Political Rights: Article 6 of the
covenant lays down that every human being has the inherent right to life which shall
be protected by law. Article 7 says that states that no one shall be subjected to torture
or to cruel, inhumane or degrading treatment or punishment.
• International Covenant on Economic, Social and Cultural Rights: Article 7
recognizes the right of everyone to enjoy just and favorable conditions of work which
ensure safe and healthy working conditions. Article 12 provides for the “the
enjoyment of the highest attainable standard of physical and mental health” and
steps for the realization of the same.

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 • Convention on the Elimination of All Forms of Discrimination against Women:
Article 12 compels the States Parties to take all appropriate measures to eliminate
discrimination against women in the field of health care in order to ensure, equal
access to health care services, including those related to family planning to women.
• The Convention on the Rights of the Child, 1989: Article 24 of the act obligates
the state parties to recognize the right of the child to the enjoyment of the highest
attainable standard of health and to facilities for the treatment of illness and
rehabilitation of health.
• The Declaration of Alma-Ata, 1978: The conference reaffirmed that health, which is
a state of complete physical, mental and social well-being and not merely the absence
of disease or infirmity, is a fundamental human right. It stated that primary health
care constitutes first element of continuing healthcare process.

CONCLUSION-

Since independence, health has been given a pivotal place by the Indian parliament and it has
made laws to cover various aspects of health in a comprehensive manner. However there is a
pressing need to recognize health as a human right through specific legislation. Legislations
must be made with a view to promote and protect health from a human right perspective,
which Indian legislation fail to do so.
At the international level, health is promoted from a human rights perspective. Various
international conventions, documents and treaties are signed and ratified by the governments.
India being a signatory to various human rights instruments has implemented the same into
its legislations and policies positively. Health legislations can be an important vehicle
towards ensuring the promotion and protection of the right to health. Human rights must be
used as a tool to determine the effectiveness and appropriateness of health schemes and goals.

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Q. 2. Critically explain the legal regime that exists in India to deal with health
emergencies or epidemics. Suppose, you are a health law activist, then what
kind of changes in law would you like to suggest dealing with such situations?
Refer to appropriate legislation, court judgments, bills, in support of your
answer.

ANSWER 2:

Legal frameworks are quintessential during emergency situations as they can delineate the
scope of the government responses to public health emergencies and also, the duties and
rights of citizens.

Both the Union government of India and the state governments are constitutionally
empowered to legislate on matters of public health. The Union law may deal with interstate
migration and quarantine. State law may provide for matters relating to public health and
sanitation, hospitals, and dispensaries. There are several central laws managing the
prevention of contagious diseases.

❖ UNION LAWS

1. EPIDEMIC DISEASES ACT, 1897

The Epidemic Diseases Act was passed in 1897 with the aim of better preventing the spread
of “dangerous epidemic diseases”. It evolved to tackle the epidemic of bubonic plague that
broke out in the then Bombay state at the time. It contains only 4 sections. Section 2 of the
Act empowers the state governments and the central government to take measures as may be
warranted or necessary to control the further spread of disease. Thus, any state government,
when satisfied that any part of its territory is threatened with an outbreak of a dangerous
disease, may adopt or authorize all measures, including quarantine, to prevent the outbreak of
the disease.
Section 2A empowers the Central government to inspect any ship leaving or arriving at any
port and for detention thereof, or of any person intending to sail or arrive thereby. Section 4
deals with legal protection to the implementing officers acting under the Act. Recently, the
Epidemic Diseases (Amendment) Ordinance, 2020 was promulgated which amends the
Epidemic Diseases Act, 1897 to include protections for healthcare personnel combating

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epidemic diseases and expands the powers of the central government to prevent the spread of
such diseases. The major highlights of the amendments are as follows-
• The ordinance defines healthcare service personnel as a person who is at risk of
contracting the epidemic disease while carrying out duties related to the epidemic
(Section 1-A(b))
• It expands the powers of the central government to regulate the inspection of any bus,
train, goods vehicle, ship, vessel, or aircraft leaving or arriving at any land port, port
or aerodrome. Further, the central government may regulate the detention of any
person intending to travel by these means.(Section 2-A)
• Persons convicted of offences under the Ordinance will also be liable to pay a
compensation to the healthcare service personnel whom they have hurt (Section 3-E)

This century-old act is now set to be replaced. The central government drafted the Public
Health (Prevention, Control and Management of Epidemics, Bio-terrorism and
Disasters) Bill, 2017 and has put in public domain for seeking comments.
According to the Bill, after a public health emergency is declared, a state government, district
authority or local authority can take measures to prevent and control the emergency. They
can quarantine people who might have been exposed to the disease, conduct medical
examinations, provide treatment and ban any activity they deem “inimical to public health”.
A public health emergency, as per the Bill, is any sudden state of danger to public health
including spread of infection, disaster or bioterrorism that mandates immediate action for its
prevention, control and management. The Bill lists a schedule of 33 diseases that are
“epidemic prone”.
Provisions of the Public Health Bill for a health emergency

● Quarantine or restrict the movement of any people possibly exposed to the disease.
● Authorise any official or person to enter and inspect, without prior notice, any premises
where public health emergency has either occurred or is likely to occur
● Prohibit any activity “inimical to public health”
● Isolate people infected from the disease
● Provide treatment, vaccination, or prophylaxis to infected people
● Ban or regulate the purchase, distribution, sale of hazardous or toxic substance
● Order hospitals/clinics to admit, isolate and manage cases arising out of the public
health emergency

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 ● Direct any clinical establishment to admit, isolate and manage cases arising out of
public health emergencies and to report to the government.

2. INDIAN AIRCRAFT (PUBLIC HEALTH) RULES, 1954

This has become relevant in the light of recent spread of COVID-19 and people coming from
abroad via commercial and govt. chartered flights. For people entering India from abroad, a
health officer appointed by the central government is posted at the port of entry as per Rule
6(2). He may also inspect the aircraft, its passengers, and its crew, and subject them to
medical examinations after their arrival as per Rule 8(1). Rule 56 states that where any
person is required under the rules to be disembarked and isolated for any period, the officer
may cause him to be removed to a hospital or another approved place and detain him in
quarantine. Rule 61 states that the health officer may also remove or order the removal of any
person, other than someone going on an international voyage, who, in his opinion is likely to
spread any quarantinable or infectious disease.

The Disaster Management Act, 2005 has provided the legal and institutional framework for
disaster management in India at the national, state and district levels. In the federal polity of
India, the primary responsibility of Disaster management vests with the state
government. The central government lays down the plans, policies and guidelines and
provides technical, financial and logistical support while the district administration carries
out most of the operations in collaboration with central and state level agencies. (Section 35,
62 and 72) The act calls upon the central government to constitute the National Disaster
Response Fund for meeting any threatening disaster situation or disaster. It mandates the
Central Government to establish NDMA as nodal authority with prime minister as its ex-
officio chairperson. (Section 6(3)) NDMA also is mandated to recommend guidelines for
the minimum standards of relief to be provided to persons affected by disaster. The
minimum standards are as follows:

• Minimum requirements to be provided in the relief camps in relation to shelter, food,

drinking water, medical cover and sanitation;

• Special provisions to be made for widows and orphans;

• Ex gratia assistance on account of loss of life as also assistance on account of damage

to houses and for restoration of means of livelihood; (Section 13)

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 ❖ STATE LAWS

1. TAMIL NADU PUBLIC HEALTH ACT,1939

In the context of health sector reforms, the Tamil Nadu model is frequently cited. The Tamil
Nadu model of public health is renowned for its success in providing quality health services
at an affordable cost especially to the rural people. Tamil Nadu is the only state with a
distinctive public health cadre in the district level and also the first state to enact a Public
Health Act in 1939. The basic strengths of the Tamil Nadu model based on the Public Health
Act of 1939 are as follows:
• Separate Directorate of Public Health: The health department has three key
directorates which are on an equal footing under the health secretary: the Directorates
of Public Health, of Medical Services, and of Medical Education. Each of these
directorates has its own dedicated budget and workforce. (Chapter-II, Section 4-5)
• Dedicated funding: The directorate is able to sustain its proactive public health work
because it has a dedicated budget, whose size is large relative spending on medical
care and medical education.(Chapter XIV Section 126-127)
• Workforce training, Incentives, Public Health Managers: The public health given
careful training. They are oriented towards an administrative and management role
rather than a clinical role examining health issues from a population wide perspective.
(Chapter-II, Section 8-16).

Tamil Nadu is successful in averting health threats and responding quickly and effectively
when confronted with disaster is due to following reasons.
1. Eradicating diseases and preventing resurgence
2. Long term planning to avert outbreaks
3. Better Management of endemic diseases
4. Co-ordination and support to local bodies in their environmental sanitation work (Chapter
VIII)

CRITICAL APPRAISAL
Coming to the second part of the question, as a health law activist I would suggest the
following changes-

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▪ In Epidemic Diseases Act, 1897 some of the issues that require revisiting are the
definition of epidemic disease, territorial boundaries, ethics and human rights
principles, empowerment of officials and punishment. The increasing rates of
international travel, more extensive use of air travel compared to sea travel, greater
migration within states for the sake of earning a livelihood, the transition from
agrarian to industrial societies, increased urbanization also needs to be addressed. The
Act is not in line with the contemporary scientific understanding of outbreak
prevention and response, but only reflects the scientific and legal standards that
prevailed at the time when it was framed as it focuses mainly on quarantine and
isolation measures rather than scientific measures of outbreak prevention and control.
There is no clear definition of whether an epidemic is “dangerous” on the basis of
the magnitude of the problem, the severity of the problem, the age of the population
affected or its potential to spread internationally.
▪ Pertaining to Health Law Bill, 2017 there are certain problems as well. There is a
need to lay emphasis on modern methods of outbreak prevention and disease control
such as establishment of surveillance system, early warning systems, Geographical
Information System mapping of diseases. The bill lacks balance between
government’s role in maintaining public health and human rights. The bill allows the
govt. to give vaccine to school children without consent of their parents which is
problematic.
▪ Pertaining to Disaster Management Act, 2005 the NDRF personnel lack sufficient
training, equipment, facilities and residential accommodation to tackle the crisis
situation properly. Robust early warning systems coupled with effective response
plans at district, state and national levels should be put in place. Climate risk
management should be addressed through adaptation and mitigation

Suggestions and Conclusions-

This low cost, high access, well-structured Tamil Nadu Health model can be emulated by
other states also because the administrative structure and finances are essentially the same
like any other state with similar cadres of medical and non-medical staff. This model
remains a prototype health care delivery system appropriate for the resource-limited
settings of the developing countries. It is beyond doubt that there has to be a major
transformation in the health infrastructure and manpower before a state plans to revamp

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 its health system in the footprints of Tamil Nadu. To conclude, the Tamil Nadu model is
the acceptable, affordable, feasible, and fruitful solution which can be reproduced by
other states towards a better health care delivery system. Policy guidelines at the macro
level are needed that would inform and guide the preparation and implementation of
disaster management and development plans across sectors. Judiciary also needs to take
the front seat and decide on health issues from a rights perspective as it did In Municipal
Council, Ratlam vs. Vardhichand & Ors wherein the SC held that public held is a state
priority and identified the responsibilities of local bodies towards the protection of
environment and sanitation which have a major bearing on public health.

Q. 3. X, aged 17 years, met with a road accident and slipped into coma. After
being treated for almost 2 years at Holy Heart Hospital, his condition did not
improve. Owing to financial problems, his father, Y, left him at the mercy of the
hospital authorities and left without a trace. A group of young doctors and
nurses took care of X and treated him for almost 5 years. One day, Y suddenly
appeared and wanted his son, X, to be euthanized.

What is legal procedure to be followed to euthanize X?

Can the Holy Heart Hospital object to the father’s wishes? If you are a lawyer
advising Holy Heart Hospital, what would be your advice?

Refer to appropriate legal provisions and court judgments in support of your

answer.

ANSWER 3:
The term Euthanasia normally implies an intentional termination of life by another at the
explicit request of the person who wishes to die. Euthanasia is generally defined as the act
of killing an incurably ill person out of concern and compassion for that person’s sufferings.

There is no statutory provision in our country as to the legal procedure for withdrawing life
support to a person in Permanent vegetative state or who is otherwise incompetent to take a
decision on his own behalf. However, Treatment of Terminally Ill Patients Bill, 2016 was
enacted to provide for the protection of patients and medical practitioners from criminal
offences arising from withdrawing life-saving procedures or assisting for the right of a

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dignified death. Section 3 of the said bill provided that every minor above the age of 16
years shall have a right to right to take a decision and express his desire to the attending
medical practitioner attending to him— for withholding or withdrawing of medical treatment
to himself. The Bill codifies passive euthanasia in a more or less similar manner as the
Hon'ble Supreme Court in its 2011 judgement in the case of Aruna Ramachandra
Shanbaug vs. Union of India. Moreover, this Bill recognizes Living Wills and medical
power-of-attorney, measures that allow a patient to make decisions before the consequences
of severe health conditions kick in. However, the said bill is still under consideration and has
not been passed by the parliament.

The troublesome question is what happens when the patient is in no condition to be able to
say whether or not he consents to discontinuance of the treatment and has also given no prior
indication of his wishes with regard to it as in the case of X. In such a situation the patient
being incompetent to express his self-determination the approach adopted in some of the
American cases is of "substituted judgment" or the judgment of a surrogate. This involves a
detailed inquiry into the patient's views and preferences. The surrogate decision maker has to
gather from material facts as far as possible the decision which the incompetent patient would
have made if he was competent. In absence of any indication from a patient who is
incompetent the test which is adopted by Courts is what is in the best interest of the patient
whose life is artificially prolonged by such life support. The question is whether it is in the
best interest of the patient that his life should be prolonged by the continuance of the life
support treatment. This opinion must be formed by a responsible and competent body of
medical persons in charge of the patient.

The Supreme court in Aruna Ramchandra Shanbaug v. Union Of India & Ors in 2011,
following the technique used in Vishakha's case, laid down the law in this connection which
was to continue to be the law of the land until Parliament makes a law on the subject-
1. A decision has to be taken to discontinue life support either by the parents or the spouse or
other close relatives, or in the absence of any of them, such a decision can be taken even by a
person or a body of persons acting as a next friend. It can also be taken by the doctors
attending the patient. However, the decision should be taken bona fide in the best interest of
the patient.

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2. Even if a decision is taken by the near relatives or doctors or next friend to withdraw life
support, such a decision requires approval from the High Court concerned.
3. In the case of an incompetent person who is unable to take a decision whether to withdraw
life support or not, it is the Court alone, as parens patriae, which ultimately must take this
decision, though, the views of the near relatives, next friend and doctors must be given due
weight.
4. When such an application is filed the Chief Justice of the High Court should constitute a
division bench who should decide to grant approval or not. Before doing so the Bench should
seek the opinion of a committee of three reputed doctors to be nominated by the Bench.
5. The committee of three doctors nominated by the Bench should examine the patient and
also consult the record of the patient as well as taking the views of the hospital staff and
submit its report to the High Court Bench.
6. With appointing the committee of doctors, the High Court shall also issue notice to the
State and close relatives of the patient, and in their absence his/her next friend, and supply a
copy of the report of the doctor's committee to them as soon as it is available. After hearing
them, the High Court should give its verdict.
7. The High Court should give its decision assigning specific reasons in accordance with the
principle of `best interest of the patient'. The views of the near relatives and committee of
doctors should be given due weight before pronouncing a final verdict.

HOWEVER, the Supreme Court later in Common Cause v. Union Of India in (2018)
explained the detailed procedure to be followed to euthanize a person in absence of any
advanced medical directive as in the case of X. These guidelines are now the law of the
land and have substituted the guidelines in Aruna’s case-
1. In case where the patient is terminally ill or undergoing prolonged treatment in respect of
ailment which is incurable, the physician may inform the hospital which shall form a hospital
medical board.
2. The hospital medical board shall discuss with the family physician and the family members
and record the minutes of discussion in writing. The family members shall be apprised of the
pros and cons of withdrawal or refusal of further treatment to the patient and if they consent
in writing, the hospital medical board may certify the course of action to be taken.
3. If the hospital medical board certifies the withdrawal or refusal of further treatment, the
hospital shall immediately inform the jurisdictional collector who shall then constitute a
medical board comprising of chief district medical officer as chairman and 3 other members.
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4. The medical board constituted by collector shall visit the hospital for physical examination
of patient and after studying medical papers may concur with the opinion of hospital medical
board. In that event intimation shall be given by the chairman of the collector constituted
medical board to JMFC (Judicial Magistrate 1st Class) and the family members.
5. The JMFC shall visit the patient and verify the medical reports, examine his conditions,
discuss with the family members of the patient and if satisfied, may endorse the decision of
the collector.
6. If the collector nominated medical board does not concur with the hospital medical board
then the nominee of the patient/family member/treating doctors/ hospital staff can seek
permission from the High court to withdraw life support by way of writ petition under Article
226 in which case the chief justice of the high court shall constitute a division bench which
shall decide to grant approval or not. The high court can also constitute an independent
committee of doctors to seek views from it.
7. To the effect that life supports is withdrawn it shall be intimated by the magistrate to the
High Court which shall be kept in digital format by the registry.

YES, the Holy Heart hospital can object to the fathers’ wishes. As a lawyer I would solicit
the following legal advice to holy heart hospital.
Out the 4 pillars as enumerated by Justice Cardozo in Schloendorff v. Society of N.Y
Hospital 1914, two are Patient Autonomy and Beneficence.
Autonomy means the right to self-determination, where the informed patient has a right to
choose the manner of his treatment. The wishes of surrogates acting on his behalf
('substituted judgment') are to be respected. The surrogate is expected to represent what the
patient may have decided had he / she been competent, or to act in the patient's best interest.
Beneficence is acting in what is (or judged to be) in patient's best interest. Acting in the
patient's best interest means following a course of action that is best for the patient, and is not
influenced by personal convictions, motives or other considerations. In Airedale NHS Trust
v. Bland 1993 it was held that doctors have a duty to act in the best interests of their patients
but this does not necessarily require them to prolong life. On the basis that there was no
potential for improvement, the treatment Bland was receiving was deemed not to be in his
best interests. It is not lawful to cause or accelerate death.

However, this can be differentiated from the instant case wherein the hospital staff considers
in the best interest of X to continue giving him life support and the treatment X is receiving is

15
considered by the hospital staff to be in his best interest. Further, In the instant case we have
no indication of X’s views or wishes with respect to life-sustaining treatments for a
permanent vegetative state. Even if there were some indications it would still be of no avail
as when X slipped into coma he was a minor and as per the judgement of Common Cause v.
Union of India 2018 he can’t make an advanced medical directive. Thus, any decision
regarding X’s treatment has to be taken by a surrogate. The staff of holy heart hospital has
looked after X for almost 5 years after X was abandoned by her father Y without leaving a
trace due to financial constraints. Thus as per the judgment in Aruna Ramchandra
Shanbaug v. Union of India & Ors in 2011, the hospital staff would be the appropriate
surrogate. If the doctors and staff of hospital treating X , acting in the best interest of the
patient, feel that life sustaining treatments should continue, their decision should be
respected.

Q. 4.(A)Suppose your father is suffering from kidney ailment and requires

transplantation. Your sister’s brother-in-law agrees to donate one of his
kidneys. Explain the legal procedure of kidney transplantation in India. Will
such organ donation be legally permissible?

Refer to appropriate legal provisions and court judgments in support of your

answer.

(8 Marks, approx. 750 words)

ANSWER: 4 (A)
The legislation called the Transplantation of Human Organ Act (THO) was passed in India
in 1994. The rules there under have been framed under Transplantation of Human Organs
Rules, 1995 which have now been replaced by the 2014 rules. Section 9(1) of the THO Act
1994 states that no human organ or tissue removed from the body of the donor (alive) shall be
transplanted into a recipient, unless the donor is the near relative of the recipient.

Transplantation of Human Organs Rules, 2014 lay down the following detailed procedure
of organ transplant (kidney in the instant case) in India depending upon whether the person is
near relative or not. Section 2(i) of the act defines “near relative” as meaning spouse, son,
daughter, father, mother, brother, sister, grandfather, grandmother, grandson or
granddaughter.
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WHEN THE DONOR IS A NEAR RELATIVE- Rule 18 lays down that in case of
transplant/ donation concerning a near relative as defined under Section 2(i) of the Act, the
competent authority or Authorisation Committee shall-
(1) Evaluate documentary evidence of relationship and evidence of identity and residence of
the proposed donor.
(2) If the competent authority opines that the relationship is not conclusively established, it
may direct DNA Profiling test.
(3) Where the proposed transplant is between a married couple, the factum and duration of
marriage must be evaluated and the documents along with the material particulars are to be
kept for records.
(4) Documents of the proof of residence or domicile and particulars of parentage should be
identical to the photo identity of the proposed donor.
(5) The Medical practitioner who will be part of organ transplantation team, shall not be a
competent authority of the transplant hospital.

PROCEDURE IN CASE OF TRANSPLANT OTHER THAN NEAR RELATIVE

Rule 19 states that where the proposed transplant is between other than near relatives the
approval will be granted by the Authorisation Committee(AC) of the hospital or by the
District or State level Authorisation Committee (if AC is not constituted).

Rule 7 (3) states that when the proposed donor and the recipient are not near relatives, the
Authorisation Committee shall-
(i) Evaluate that there is no commercial transaction between the recipient and the donor and
that no payment has been made or promised there under.
(ii) Prepare an explanation of the link between them and the circumstances which led to the
offer being made and why the donor wishes to donate.
(iii) Examine the documentary evidence of the link along with their old photographs.
(iv) Ensure that there is no middleman involved and the donor is not a drug addict.
(v) Evaluate that financial status of the donor and the recipient and any gross disparity
between the statuses of the two.
(vi) Ensure that the near relative or any adult person related to donor is interviewed regarding
awareness about his or her intention to donate an organ or tissue.

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YES, such donation is legally permissible as per Section 9(3) of THO act. The said relation
(sister’s brother in law) does not come within the purview of ‘near relative’. Thus, such
donation will be covered under Section 9(3).
• Section 9(3) of the said act stipulates that if a donor agrees for a live donation and
authorizes the removal of any organ or tissue, not being a close relative by reason of
affection or attachment towards the recipient or for any special reasons, such organ or
tissue shall not be removed and transplanted without the prior approval of
Authorization Committee.
Thus, the donor can donate but he will have to take prior approval from the authorization
committee and follow the above mentioned procedures. The above said contention can also
be substantiated with the following case laws.

In Parveen Begum v. Appellate Authority, following Kuldeep Singh dictum the court held
that the Act and the Rules do not seek to prohibit, but to only regulate the transplant of organs
and tissues. Only commercial transaction in the giving and taking of organs and tissues is
prohibited. However, donations offered out of love and affection - even amongst those who
are not near relatives, is permitted. Love and affection need not necessarily be felt only for
one's own blood or spouse, but could also extend to those not so closely related, or for those
not related at all.
In Kuldeep Singh & Ors v. State of Tamil Nadu & Ors the court held where the donor is
not "near relative" as defined under the Act, the situation is covered by Section 9(3). In case
the donor is not a near relative, he must establish that removal of the organ for transplantation
into the body of the recipient is because of affection or attachment or for any special reasons.
The Authorisation Committee is, therefore, required to satisfy that the real purpose of the
donor authorizing removal of the organ is by reason of affection or attachment towards the
recipient or for any other special reason only.

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(B)Assume the Government of India seeks your legal opinion regarding the
change in the abortion law as to whether absolute right to abortion can be
given to the mother. Write a legal opinion for the GoI.

Refer to appropriate legal provisions and court judgments both from India and
other countries in support of your answer.

(7 Marks, approx. 750 words)

ANSWER (B)
NO, absolute right of abortion should not be given to mother in India as in the case of Canada
(where abortion can be done at any stage) as unlike Canada we do not recognize the concept
of BORN ALIVE RULE, which states foetus is not a person. However, the right to
reproductive choice and privacy must be balanced against the right of the unborn to live as
our law recognizes (like TPA) the rights of unborn person as well.

The Medical Termination of Pregnancy (MTP) Act, 1971 was enacted two years before the
landmark judgement of the US Supreme Court in Roe v Wade wherein the US Supreme
Court while deciding the validity of law in Texas which criminalized abortion except where
it was for saving the life of the mother held that privacy right is broad enough to encompass
woman’s decision whether or not to terminate pregnancy. It laid down a trimester based
framework for termination of pregnancy. So far as first trimester is concerned it held that a
woman enjoyed the greatest protection to her reproductive right.

The current stand of the government is somewhat premised on partial ruling in Roe v. Wade
as the govt. in Nikhil Datar v. Union of India stated in the court that “Pregnant woman’s
right to abort her pregnancy is not an absolute right, and the right to abortion must be
balanced against the compelling State interest of protecting the mother’s health and the life
of the fetus/unborn child.”
However, the law needs substantial alterations to balance the reproductive rights of mother and of
the life of foetus.
Section 3(2)(a) of the MTP Act states that where the length of pregnancy does not exceed 12
weeks i.e. the first trimester it may be terminated by a medical practitioner if he /she opines that
▪ The continuance of pregnancy would involve a risk to the life of the pregnant woman or
of grave injury to her physical or mental health or

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 ▪ There is a substantial risk that if the child is born, it would suffer from physical or mental
abnormalities as to be seriously handicapped.
Section 3(2)(b) permits termination of pregnancy beyond 12 weeks and not exceeding 20
weeks provided two registered medical practitioners opine that the above two reasons
exist. Section 5 enables termination of pregnancy beyond 20 weeks where the registered
medical practitioner is of the view that termination of such pregnancy is immediately
necessary to save the life of the pregnant woman.
However the above mentioned law needs a serious overhaul to be in line with the catena of
legal pronouncements.
Section 3(2)(a) is violative of right to privacy and right to reproductive choice of a woman
which inhere and are recognized by Article 21 of the Constitution held by SC in Suchitra
Srivatava v. Chandigarh Administration (2009) and In KS Puttaswamy Vs UOI (2017) . It
has been held by SC that family, marriage, procreation and sexual orientation are all integral
to the dignity of individual, further it held that the State may intervene to protect legitimate
State interests but it has to ensure fulfilment three fold requirement. They are-
• Existence of a law
• Need in terms of a legitimate State interest
• Law to be proportional to the objects and needs sought to be fulfilled.
It is submitted that Section 3(2) (a) fails both the second and third test. So far as first
trimester is concerned there is no need to make termination of pregnancy subject to
formation of opinion of medical practitioner and the women should be allowed to terminate
pregnancy at free will. Till the first trimester women’s reproductive choice must enjoy
complete protection and only laws aimed at safer abortion be made by parliament. Recently
Supreme Court of Kansas in Hodes & Nauser v. Derek Schmidt has held that women have
a fundamental right to safe abortions. Even globally termination of pregnancy on the request
of the woman is permitted in several countries with varied gestational limits ranging from 12
weeks to 24 weeks.

Further as per Section 3(2)(b) restricting the permissible length of pregnancy to 20 weeks is
excessively harsh as in many cases many serious foetal anomalies are diagnosed after 20
weeks as noted in the case of XVZ v. UOI 2019 and thus it may be extended to 24 weeks (as
stipulated in the 2020 Amendment Bill). Further the requirement of approval of 2 medical
practitioner must be reduced to one. The practitioner must protect the privacy of the woman
(as stipulated under section 5A of the 2020 amendment bill). In Explanation 2 to Section
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3(2) the protection afforded only to married woman is discriminatory and violative of Article
14 of the Constitution. This provision also adversely affects the sexual autonomy of single
women and must include them as well.

Further in case of rape victims and minors who are forced to get pregnant, they must be
allowed to abort at any time provided it does not risk the life of that women/minor that too
without taking permission from the medical board and the court as women are forced to
approach Supreme Court and High Court which causes immense financial and other social
hardships. The time taken in adjudication by courts also is detrimental to the health of the
woman. In many cases women deliver the baby before the opinion of medical board or court
of law comes. This leads to mental agony.

Section 5 fails to accommodate those contingencies where the registered medical practitioner
opines that the continuance of pregnancy involves grave injury to the physical health (not
life threatening) or to the mental health of the mother. It also fails to accommodate where
pregnancy is alleged to have been caused as a result of rape.
Thus in line with the current medical advancements and keeping other Indian laws in
harmony these changes must be made to the law.

The decision to terminate a pregnancy is never an easy or mechanical decision and it takes a
severe toll on the affected parties, especially the woman. There is a need to strike a balance
between the rights of women to control their bodies and the legitimate interests of the state to
prevent selective sex determination as well as protect the interests of the woman and the
unborn foetus.

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Q. 5.(A)Assume that an Artificial Intelligence-enabled MRI machine
malfunctioned and gave faculty diagnosis. However, relying on that diagnosis,
the doctor prescribed you with wrong medicine and consequently, you
suffered. Whom would you hold legally liable? What could your challenges?
You may take recourse to appropriate legislation including the Consumer
Protection Act and court judgments in support of your answer.

(9 Marks, approx. 900 words)

ANSWER 5 (A)
The liability in this case depends on case to case basis and on various factors. There can be
scenarios when the doctor can be made liable and there can be scenarios when the
manufacturer can be made liable.

LIABILITY OF MANUFACTURER (Assuming the equipment was properly

maintained and used by the doctor)

In Bolam v. Friern Hospital Management Committee (1957) and further, in Jacob

Mathew v. State of Punjab court held that so long as a doctor follows a practice acceptable
to the medical profession and standard of care, he cannot be held liable for negligence.

Due to its impressive accuracy rates in the scope of diagnosis and choice of course of
treatment, reliance on results an MRI machine is to be deemed an acceptable medical
practice. Further a doctor can’t be made liable when he does not know the inner workings of
the equipment. If the doctor does not rely on such equipments and prescribes drug on his
own, he will be held liable on grounds of failure to exercise reasonable care and thus
violating the guidelines of Martin F. D'Souza v Mohd. Ishfaq 2009, wherein it was held
that no prescription should ordinarily be given without actual examination.

Thus, it can be concluded that the doctor was not at fault and by virtue of the doctrine of ‘loss
lies where it falls’, the claimant will go uncompensated unless it can be shown that defendant
was at fault. Hence the doctor is not liable to compensate the claimant.

Although AI based equipment are used as ‘decision aides’ but there are exceptions where the
doctor may not be liable-

1. Doctor followed standard duty of care

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2. The fault lies with the developer of product.

In the instant case if the equipment gave faulty result, the fault has to lie on the developer of
the product for supplying defective equipment.
• Section 2(10) of the Consumer Protection Act, 2019 defines ‘defect’ as meaning any
fault, imperfection or shortcoming in the quality and standard, among other things
which is required to be maintained in relation to any goods or product. Here, there
was an implied contract between the manufacturer and the doctor that the machine
would work properly which it did not.
• Section 2(22)(iii) of the act states harm in relation to product liability includes
personal injury, which the patient has suffered in the instant case.
• Section 2(34) states that "product liability" means the responsibility of a product
manufacturer of any product or service, to compensate for any harm caused to a
consumer by such defective product manufactured or sold or by deficiency in
services.
• Section 84(1)(a) states that a product manufacturer shall be liable in a product
liability action if there is a manufacturing defect.

Culling out from all these definitions it can be concluded that the manufacturer of that AI
based MRI machine is to be made liable for product liability action on the basis of the fact
that there was a manufacturing defect that lead to the false diagnosis.

Further, the manufacturer can be made liable for strict liability without the burden of showing
his negligence or privity. The only things required to be proved are-
1. Harm was caused to the claimant
2. Causal link between the action and the resulting harm.
In the instant case it is clear that the harm was caused to the patient by faulty diagnosis. In
order to establish causal link between the action and resulting harm, recourse can be taken to
a landmark case of Donoghue v Stevenson 1932 wherein the ‘neighbourhood’ principle was
propounded by Lord Atkins. He stated that a person should take reasonable care to avoid acts
or omissions that he can reasonably foresee as likely to cause injury to the neighbour.
Neighbour includes all persons who are so closely and directly affected by the act that the
actor should reasonably think of them when engaging in the act or omission.

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The case is important as it established the liability of manufacturers to consumers who don’t
have a contractual relationship. Hence, the patient affected by faulty treatment can be treated
as the neighbour of the manufacturer. Further even if there was an intermediary (doctor), he
had no means of finding out the defect as it was a latent one.

LIABILITY OF DOCTOR(Considering doctor is the owner of hospital and the

radiologist)

Where there is misuse of the product, the hospital or doctor is liable. Also, where there is
actual knowledge of the defect, liability is imposed for the continued use. Thus if the doctor
used the MRI machine wrongly or had the knowledge that the machine was giving faulty
diagnosis, the continued usage of such AI based equipment may constitute malpractice on the
part of the doctor. Reliance can be placed on Shepherd v. McGinnis, U.S 1964 wherein the
doctor was held liable as he had knowledge that the manufacturer was supplying faulty
sutures and he continued the use of the same.
Doctors also have a duty to inspect the equipment they use and provide for the care of
patients. For the doctor, this duty generally extends only to patent or discoverable defects.
Thus if there was a patent defect in the MRI machine which could have been discovered by
the doctor, then the doctor would be held liable in that instance as well. In Nelson v Swedish
Hospital, U.S 1954 the doctor was held liable for failing to inspect the X-ray equipment
which had a loose bolt which lead to injuries to the claimant. The court held that it was a
failure to take reasonable care on the part of doctor.

Further, In Indian Medical Association v. V.P. Shantha and Ors. , the court held that a
medical practitioner renders a 'service' and can be proceeded against for 'deficiency in
service' before a forum under the Consumer Protection Act, 1986.

Thus if the above discussed circumstances exist, there is a deficiency in service by the doctor.
Section 2(11) of the act states that "deficiency" means any fault, imperfection, shortcoming
or inadequacy in the quality, nature and manner of performance and in relation to services it
includes any act of negligence or omission or commission by such person which causes loss
or injury to the consumer.

Here, the patient can be called a consumer of the services of the doctor and doctor has been
negligent, he will be liable for such shortcoming in the manner of performance of the scan.

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CHALLENGES
The possible challenge is to determine at what point an AI’s error crosses over from an
unfortunate medical mistake to an unacceptable, possibly negligent one and, can doctors or
health care institutions using the AI be truly held liable for what might go wrong when they
don’t even know the inner workings of the tool?. Another one to determine what will be the
standard duty of care while using AI equipment. Due to the opaqueness and autonomous
nature of algorithms of the AI based equipment, principles of control and forseeability can’t
be applied to it rigidly. AI presupposes a self-learning system that learns from its experience
and takes autonomous decisions, proving a defect in the technology with sufficient certainty
seems to be insurmountable. In view of all possible dangers and grounds for liability
surrounding the use of AI technology, it is highly recommended to have appropriate liability
insurance in place.

(B)Suppose an ENT specialist wants to start a clinic in his city. He seeks your
advice to establish it. Explain the legal procedure which he should follow.
Should we compulsorily register all clinics including such one-doctor clinics?
Give your opinion.

Refer to appropriate legal provisions in support of your answer.

(6 Marks, approx. 600 words)

ANSWER 5 (B)

The Clinical Establishment (Registration and Regulation) Act, 2010 read in conjunction
with the Clinical Establishments (Central Government) Rules, 2012 lays down the
procedure for registration of clinical establishments. Thus, the legal procedures that the ENT
specialist will have to follow are as follows:

Section 11 of the Act, makes the registration of clinical establishment mandatory.

Section 12 of the Act lays down conditions for registration to be fulfilled by Clinical
establishments. They are:

Minimum standards of facilities and services, minimum requirements of personnel,

provisions for maintenance of records and reporting, provision of staff and facilities for

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medical examination and treatment required to stabilise the emergency medical condition of
an individual who comes or is brought to such clinical establishment.

Section 14 of the act states that for the registration of the clinical establishment under section
10, an application in the prescribed format shall be made to the authority in person, by post or
online is such form and with such details as may be prescribed under the rules. (Provisional
Registration)

Section 23 states that if the standard for such clinic has been notified by the central govt.
such provisional registration may not be renewed after 2 years.

Section 24 talks about application for permanent registration. Section 28 states that
permanent registration shall be given registration only when a clinical establishment fulfils
the standards notified by the central govt.

All these standards and requirements must meet the standards prescribed by the govt. from
time to time and in accordance with the CE Rules, 2012.

Rule 9 of the CE Rules, 2012 lays down other conditions required to be followed in order to
obtain registration. They are as follows-
(i) Display the Registration certificate at a prominent place.

(ii) Display the rates charged for each type of service provided and facilities available, at a
conspicuous place in local language and in English.

(iii) Charge the rates for each type of procedures and services in range as prescribed by the
government.

(iv)Ensure compliance with Standard Treatment Guidelines as prescribed by the appropriate

government.

(v) Maintain Electronic Medical/Health Records of every patient.

(vi)Maintain and provide information and statistics in accordance with all other applicable
laws and rules in force.

YES, all clinics including one-doctor clinics must be mandatorily registered under this Act.
The reasons for it are-
• Better surveillance and relief from exorbitant money charged by private healthcare.

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 • Deterrence against quackery as only recognized system of medicine are given
registration.
• Effective regulation and improved quality of healthcare as the law states that a health
establishment should have sufficient sitting space, provision for proper waste
management and must adhere to certain set standards if they have facilities like
operation theatre and labour room
• Better management of emergency situations and maintenance of digital registry of
clinical establishment.
• Accountability is vital in health sector as private establishment are known to botch up
cases.
• Applicable to all types of health establishments and all streams of medicine, aiming to
streamline healthcare services across the country, while ensuring private hospitals do
not engage in unethical practices.
• Allows patients or their kin to lodge complaints upon which action will be taken
against the establishment. Also mandates maintaining data related to patients.

However, there are certain problems in the act which needs to be addressed-
• The stringent requirements, of having number of trained paramedical staff, will not
be possible to meet, due to the shortage of trained manpower. Even if this is fulfilled
especially by one- doctor clinics, the cost of treatment will raise manifold and the
poor will be the worst affected.
• Further as per Section 12 of the act, all clinical establishments are expected to
intervene to “stabilise” the patient with an emergency medical condition before
transferring them. This imposes too much responsibility on them. Small-time
practitioners can only offer preliminary care and first aid. If it is made applicable on
them, it will affect such practitioners, who cater to 80 per cent of the people seeking
healthcare.
Thus, the protest against the implementation of the said act by vested private establishments
is unwarranted and arguments against it are irrational. Private clinics and hospitals should not
be allowed to dictate the terms of CEA. However, as discussed above act requires certain
tweaking after the removal of which this act will go a long way in overhauling the health
sector and proving a major relief to the poor and disadvantaged who are exploited the most.

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