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Overview of Health Law in India

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33 views52 pages

Overview of Health Law in India

Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd

Health law

Contents:

 Module 1
-Introduction to health law - what is health law - Interface between law
and health - Role of the state in ensuring health - Recognition of health as
a human right - International perspective - WHO conventions

 Module 2
Health law on Indian context - Indian constitution and health - Right to
health - Approach of judiciary in realization of right to health - Right to
emergency care - Regulation of public and private health care systems-
Health delivery systems in India - Allopathy, Ayurveda, homeopathy,
unnani and applied systems

 Module 3
Medical ethics - Professional values - Autonomy, justice, beneficence, non-
malfeasance - Patient’s rights - Informed consent - Medical confidentiality
- Access to medical records - Electronic medical records – regulation of
medical profession - Medical negligence

 Module 4
Right to health of vulnerable population -children -elderly -women -tribal -
disabled -mentally challenged

 Module 5
Euthanasia - Drug trials - Clinical research - Assisted conception HIV/AIDS
and Indian legal scenario - Organ transplant - Surrogacy PVS patients -
Telemedicine - ECT

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
Module 1
What is Health law?
WHO defines health as “a state of complete physical, mental and social well-being
and not merely the absence of disease or informality.”
Health law is a field of law that encompasses federal, state and local laws, rules,
regulations and other jurisprudence among providers, payers and vendors to the
health care industry and its patients, and delivery of care services, with an emphasis
on operations, regulatory and transactional issues.

Interface between law and health


Medicine and law were related from early times. This relation resulted as a
necessity of protecting communities from the irresponsible acts of impostors.
The law indirectly influences medical practice by structuring the delivery and
financing of medical services, and it does so directly in three major ways:
- license requirements,
-restrictions on practice, and
- redress for wronged patients.
The law generally supports customary medical practice and provides the medical
profession with a great deal of autonomy. A dramatic example is the
determination of death and the issuance of a death certificate.

 Role of state in ensuring health:


The State priority is reflected through its policies and programmes undertaken by
governments. Government has identified six priority programme areas, namely urban
low cost sanitation, urban waste water management, urban solid waste management
including hospital waste management, rural environmental sanitation, industrial
waste management and air pollution control, and strengthening of health surveillance
and support services.
Health is a State subject in India. However, many states do not have a clear Health
Policy. The strategies of the states are mostly guided by the National Health Policy
and the National Programs.
 The Government is responsible to provide health services to the public. In India
the health services are provided both by the Central and State Governments. But
the available resources with governments are not enough to cover all citizens
under health care services. Hence, services provided by private practioner,
hospitals and nursing homes are predominant.

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
 Right to health and emergency medical care is an aspect of right to life under
Article 21 of the Constitution, it has been acknowledged as a fundamental right of
the people. This has been echoed in the International Conventions on Human
Rights.
 Government initiatives in the public health sector have recorded some
noteworthy successes over time. Smallpox and Guinea Worm Disease have
been eradicated from the country; Polio is on the verge of being eradicated;
Leprosy, Kala Azar, and Filariasis can be expected to be eliminated in the
foreseeable future. The period after the announcement of NHP-83 has also seen
an increase in mortality through ‘life-style’ diseases diabetes, cancer and
cardiovascular diseases.
 Another area of grave concern in the public health domain is the persistent
incidence of macro and micro nutrient deficiencies, especially among women and
children. In the vulnerable subcategory of women and the girl child, this has the
multiplier effect through the birth of low birth weight babies and serious
ramifications of the consequential mental and physical retarded growth.

The six strategies that aim at streamlining organizational set-up are:


• Implementation of public health programmes through local self governments.
• Set up of organized urban primary health care infrastructure.
• Co-operation of private health practitioners in national disease control programmes.
• Integrated disease control network from the lowest rung of public health
administration to the highest level under the Central Government by 2005.
• Identification of specific programmes targeted at women's health and
• Baseline estimates for the incidence of TB, Malaria and Blindness by 2005.

Six other proposals deal with the aspects of regulation in the health care
system:
 Setting up of a Medical Grants Commission.
 Raising postgraduate seats in 'public health' and 'family medicine' to 25 per cent.
 Legislation for minimum infrastructure standard by 2003.
 Legislation for minimum quality standard by 2003.
 Strengthening of food and drug administration

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
 Recognition of health as human right
The right to health is a fundamental part of our human rights and of our
understanding of a life in dignity. Internationally, it was first articulated in the 1946
Constitution of the World Health Organization (WHO), whose preamble defines
health as “a state of complete physical, mental and social well-being and not merely
the absence of disease or infirmity”. The preamble further states that “the enjoyment
of the highest attainable standard of health is one of the fundamental rights of every
human being without distinction of race, religion, political belief, economic or social
condition.”
The 1948 Universal Declaration of Human Rights also mentioned health as part of
the right to an adequate standard of living (art. 25). The right to health was again
recognized as a human right in the 1966 International Covenant on Economic, Social
and Cultural Rights.

Key aspects of right to health


 The right to health is an inclusive right: We frequently associate the right
to health with access to health care and the building of hospitals. This is
correct, but the right to health extends further. It includes a wide range of
factors that can help us lead a healthy life;
 Safe drinking water and adequate sanitation;
 Safe food;
 Adequate nutrition and housing;
 Healthy working and environmental conditions;
 Health-related education and information;
 Gender equality.
 The right to health contains freedoms: These freedoms include the right to
be free from non-consensual medical treatment, such as medical experiments
and research or forced sterilization, and to be free from torture and other
cruel, inhuman or degrading treatment or punishment.
 The right to health contains entitlements:
 The right to a system of health protection providing equality of
opportunity for everyone to enjoy the highest attainable level of health;
 The right to prevention, treatment and control of diseases;
 Access to essential medicines;
 Maternal, child and reproductive health;
 Equal and timely access to basic health services;
 The provision of health-related education and information;

 Health services, goods and facilities must be provided to all without any
discrimination.
 All services, goods and facilities must be available, accessible,
acceptable and of good quality.

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
 The link between the right to health and other human rights

Human rights are interdependent, indivisible and interrelated. This means that
violating the right to health may often impair the enjoyment of other human rights,
such as the rights to education or work, and vice versa. These include the rights to
food, to water, to an adequate standard of living, to adequate housing, to freedom
from discrimination, to privacy, to access to information, to participation, and the right
to benefit from scientific progress and its applications.

 International perspectives

The right to the highest attainable standard of health is a human right recognized in
international human rights law. The International Covenant on Economic, Social and
Cultural Rights, recognizes “the right of everyone to the enjoyment of the highest
attainable standard of physical and mental health.” It is important to note that the
Covenant gives both mental health, which has often been neglected, and physical
health equal consideration.

 Conventions
 International Covenant on Economic, Social and Cultural Rights, art. 12

1. The States, Parties to the present Covenant recognize the right of everyone to
the enjoyment of the highest attainable standard of physical and mental health.
2. The steps to be taken:
(a) The provision for the reduction of the stillbirth rate and of infant mortality and for
the healthy development of the child;
(b) The improvement of all aspects of environmental and industrial hygiene;
(c) The prevention, treatment and control of epidemic, endemic, occupational and
other diseases;
(d) The creation of conditions which would assure to all medical service and
medical attention in the event of sickness.
 International human rights treaties recognizing the right to health

• The 1965 International Convention on the Elimination of All Forms of Racial


Discrimination: art. 5 (e) (iv)
• The 1966 International Covenant on Economic, Social and Cultural Rights
• The 1979 Convention on the Elimination of All Forms of Discrimination against
Women
• The 1989 Convention on the Rights of the Child: art. 24

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
 Declaration of Alma-Ata, 1978
 The Declaration affirms the crucial role of primary health care, which addresses
the main health problems in the community, providing promotive, preventive,
curative and rehabilitative services accordingly (art. VII). It stresses that access to
primary health care is the key to attaining a level of health that will permit all
individuals to lead a socially and economically productive life (art. V) and to
contributing to the realization of the highest attainable standard of health.

Module 2
 Indian constitution and health
The Constitution incorporates provisions guaranteeing everyone’s right to the
highest attainable standard of physical and mental health.
Article 21 of the Constitution guarantees protection of life and personal liberty to
every citizen.
Bhandhua Mukthi Morcha v. union of india The Supreme Court has held that the
right to live with human dignity, enshrined in Article 21, derives from the directive
principles of state policy and therefore includes protection of health.
State of Punjab v. Mohinder singh chawla it has also been held that the right to
health is integral to the right to life and the government has a constitutional obligation
to provide health facilities.
Paschim Banga Khet Mazdoor Samity v. State of West Bengal Failure of a
government hospital to provide a patient timely medical treatment results in violation
of the patient’s right to life.
Sheela Barse v. Union of India Public interest petitions have been filed under
Article 21 in response to violations of the right to health. They have been filed to
provide special treatment to children in jail.
Right to health is an issue of fundamental importance in the Indian society. The
responsibility to protect, respect and fulfill the right to health lies not only with the
medical profession but also with public functionaries such as administrators and
judges.
 The Preamble to the Constitution highlights some of the core values and
principles that guide the Constitution of India. Although the preamble is not
regarded as a part of the Constitution and is not enforceable in a court of law, the
Constitution is interpreted in the light of the preamble. The Preamble directs the
state to initiate measures to establish justice, equality, ensure dignity, etc. which
have a direct bearing on people’s health.

 When right to healthcare is seen within the constitutional framework it is clear that
the constitution of India does not provide for right to health in any way. Right to
Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
health has been evident in India through the various case laws decided by the
Indian judiciary from time to time.

 At the time of formation of the Indian constitution right to health was placed under
the directive principles of state policy because direct enforcement of the right to
health was found difficult by the makers of the constitution.

 Initially the Supreme Court of India enforced right to health among the people
through various PIL which came before the Indian judiciary. With the passage of
time the judiciary found that right to life under article 21 is incomplete without right
to live with human dignity which includes various other rights like education,
livelihood, health and housing etc. thus right to health became a part of
fundamental rights and was incorporated under article 21 of the Indian
constitution.

 DPSP:- According to Article 47 of the Indian constitution the state shall regard the
raising of the level of nutrition and the standard of living of its people and the
improvement of public health as among its primary duties and, the state shall
prohibit the consumption of intoxicating drinks and drugs which are injurious to
health except for medical purposes.
 Article 21 read with Articles 14, 46, and 47 in various situations reiterated the
importance of right health and medical care is an aspect of right to life and
personal liberty of the citizens.
 Articles 41, 42 and 47 of the Directive Principles enshrined in Part IV of the
Constitution provide the basis to evolve right to health and healthcare.

 In 1987 a very important decision of the Supreme Court came out in public
interest in the case of Vincent Panikurlangara vs. Union of India & Ors, in this
case it was held that in a welfare State, it is the obligation of the State to ensure
the creation and maintaining of conditions congenial to good health. The right to
enjoy life as a serene experience, in quality far more than animal existence is
thus recognized. The right to live in peace, to sleep in peace and the right to
repose and health are part of the right to live. We recognize every man's home to
be his castle, which cannot be invaded by toxic fumes, or tormenting sounds.

 In the case of CESC Ltd. vs. Subash Chandra Bose, The SC relied on
international instruments and concluded that right to health is a fundamental right.
It went further and observed that health is not merely absence of sickness, “The
term health implies more than an absence of sickness. Medical care and health
facilities not only protect against sickness but also ensure stable manpower for
economic development. Facilities of health and medical care generate devotion
and dedication to give the workers’ best, physically as well as mentally, in
productivity. It enables the worker to enjoy the fruit of his labour, to keep him
physically fit and mentally alert for leading a successful economic, social and
cultural life. The medical facilities are, therefore, part of social security and like
gilt edged security, it would yield immediate return in the increased production or

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
at any rate reduce absenteeism on grounds of sickness, etc. Health is thus a
state of complete physical, mental and social well-being and not merely the
absence of disease or infirmity

 Very significantly, while adjudicating on the social right to health, the Supreme
Court has specifically considered the issue of availability of resources. This was
discussed in the popular case of Paschim Banga Khet Mazdoor Samity & Ors
vs State of West Bengal & Ano where the Court addressed the issue of
adequacy and availability of emergency medical treatment. In this case, Hakim
Sheikh, a member of the Paschim Banga Khet Mazdoor Samity, fell off a train
and suffered serious head injuries. He was brought to a number of State
hospitals, including both primary health centers and specialist clinics, for
treatment of his injuries. Seven state hospitals were unable to provide emergency
treatment for his injuries because of a lack of bed space and trauma and
neurological services. He was finally taken to a private hospital where he
received his treatment. Feeling aggrieved by the callous and insensitive attitude
of the government hospitals in Calcutta in providing emergency treatment the
petitioner filed this petition in the Supreme Court and sought compensation. The
issue presented to the Court was whether the lack of adequate medical facilities
for emergency treatment constituted a denial of the fundamental right to life under
Article 21.
It was held that Article 21 of the Constitution casts an obligation on the State
to take every measure to preserve life. The Court found that it is the primary duty
of a welfare State to ensure that medical facilities are adequate and available to
provide treatment. Due to the violation of the right to life of the petitioner,
compensation was awarded to him. In this case, the Supreme Court recognized
that financial resources are needed for providing these facilities.

 In the case of Naz Foundation vs Government of NCT of Delhi and Others


The writ petition was filed by Naz Foundation, an (NGO) as a Public Interest
Litigation to challenge the constitutional validity of Section 377 of the IPC, which
criminally penalizes what is described as "unnatural offences", to the extent that it
violates article 21 of the Indian constitution. It was submitted that Section 377
acts as a serious impediment to successful public health interventions. According
to NACO, those in the High Risk Group are mostly reluctant to reveal same-sex
behaviour due to fear of law enforcement agencies, keeping a large section
invisible and unreachable and thereby pushing the cases of infection
underground making it very difficult for the public health workers to even access
them. The situation is aggravated by the strong tendencies created within the
community who deny MSM (men who have sex with men) behaviour itself. Since
many MSM are married or have sex with women, their female sexual partners are
consequently also at risk for HIV/infection. The NACO viewed it imperative that
the MSM and gay community have the ability to be safely visible through which
HIV/AIDS prevention may be successfully conducted. Clearly, the main
impediment is that the sexual practices of the MSM and gay community are
hidden because they are subject to criminal sanction. The court declared in its

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
decision that Section 377 IPC criminalizes consensual sexual acts of adults in
private, so far as it is violative of Articles 21, of the Constitution of India.

In all the above judgments, we see the Supreme Court carving out a Right to Health
from the various judicial pronouncements which came before the court and thus
incorporated this right within Article 21 of the Indian Constitution.

 Mental disability and right to health


Section 81 of Mental Health Act, 1987 stipulates that:
1. “No mentally ill person shall be subjected during treatment to any indignity
(whether physical or mental) or cruelty
2. No mentally ill person under treatment shall be used for purposes of research,
unless-
(i) such research is of direct benefit to him for purposes of diagnosis or
treatment, or
(ii) such person, being a voluntary patient, has given his consent in
writing or where such person (whether or not a voluntary patient) is
incompetent, by reason of minority or otherwise, to give valid consent,
the guardian or other person competent to give consent on his behalf,
has given his consent in writing, for such research.”

In S.P. Sathe v State of Maharashtra , the Bombay High Court regulated the
prescription of indiscriminate electric shocks to mentally ill persons. The directions
included that reports be made whenever electric shocks were given by a prison
psychiatrist. A writ petition in the High Court of Bombay at Panaji challenged the
practice of administrating ECT without anaesthesia at the Institute of Psychiatry and
Human Behaviour (IPHB), Panaji, Goa. Patients at the IPHB were administered ECT
without anaesthesia because no anaesthetist was available and the machine was
no.
The practice was barbaric, inhuman and hence in violation of Article 21 of
the Constitution; in Violation of Section 81 (Chapter VIII) of the Mental Health Act,
1987, providing that no mentally ill person be subjected during treatment to indignity
or cruelty. Without anaesthesia it could lead to patient discomfort, fractures of the
spine and long bones, and dislocations particularly of the jaw. The ECT was also
being administered without the patients’ informed consent.

 HIV and the right to health


This is a social right to health which has been very well articulated to
persons suffering with HIV/AIDS, due to the large levels of discrimination faced by
them. The courts have protected people with HIV/AIDS against discrimination in
employment and services, but the issue of the right to health of persons with HIV is a
new and emerging area of adjudication. A recent Full Bench decision of the Andhra

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
Pradesh High Court views AIDS as a public health issue and one that needs to be
articulated in terms of the constitutional guarantee to the right to life, making
employers and health providers accountable for any negligence, omission or failure
to conform to procedure.
One of the first litigations on the issue of HIV/AIDS in India is Lucy D’ Souza vs.
State of Goa in which S. 53(1) (vii) of the Goa Public Health Act, 1987, empowered
the government to isolate a person suffering with AIDS, was challenged.
Another case which brought the issue of privacy before the courts is Mr. X
vs. Hospital Z This petition dealt with two issues; firstly, right to privacy of a patient,
specially an HIV/AIDS patient and secondly, the right of an individual to be
safeguarded from any threat to her health. The Petitioner was tested positive for HIV
by the Respondent hospital, which acted upon the discovery and informed
Petitioner’s fiancée about this condition because of which the marriage was called off
and his community ostracized him. Thus, this petition was filed claiming that there
was a breach of privacy and confidentiality by the hospital and the doctor. The
Supreme Court observed that the relationship between doctor and patient was that
of trust. No information acquired during course of treatment should be divulged
without the prior permission of the patient .
The statutory provisions impose a duty upon the person not to marry as
marriage would have the effect of spreading the infection, which obviously is
dangerous to life of the woman whom he marries. Therefore the hospital’s act was to
protect the life of another person therefore, they could not be held liable for
consequences of their act.

 Women’s right to health


Right to Protection of Life and Personal Liberty (Article 21) ensures that no
person shall be deprived of his / her life or personal liberty, except according to the
procedure established by law. While the provision of health services is essential to
ensure good health pregnancy, childbirth and the postpartum period are one of the
riskiest stages of a woman’s life. Every year over 1, 30,000 Indian women lose their
lives in pregnancy and childbirth. The right to life can be extended to include the
health rights of mothers to go safely through pregnancy and childbirth. However, this
right has not been explicitly guaranteed, though the Indian Constitution does make
reference to maternity related benefits for the women.
In Ramakant Rai and Health Watch Up and Bihar vs. Union of India
petitioners contended that the respondents have totally failed and neglected to
implement the Ministry of Health and Welfare’s Guidelines on Standards of Female
Sterilization (the Sterilization Guidelines), which were enacted in October 1999. The
petition relied upon domestic law, too, arguing that the respondents have “failed to
realize” the constitutional right to health, which is a part of the right to life enshrined
in Articles 14, 15, 21, and 47 of the Constitution of India. In addition, the petition cited
domestic case law in which the Supreme Court established the right to health, held
the government vicariously liable for medical negligence, and recognized a right to
Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
compensation stemming from governmental negligence. In response to the PIL, the
central government has issued a National Family Planning Insurance Scheme to
award monetary compensation to women and their families in cases of
complications, pregnancy or death after sterilization procedures in either government
or accredited private health facilities.
In Supreme Court Legal Aid Committee vs. State of Bihar the Supreme Court
held that the responsibility to provide immediate medical treatment to an injured
person in a medico-legal case extends even to the police. Thus, where the deceased
who was lynched by the mob for attempting to rob passengers of train, died because
of negligence of the police in taking him to a hospital on time and also for the
inhuman manner in which he was bound up and dumped in the vehicle, the Court
held that this amounted to a violation of right to life and the State was bound to pay
Rs.20, 000 as compensation for the loss of life.
In a historic judgment in Consumer Education and Research Centre vs. Union
of India14 held that the right to medical care is a fundamental right under Art.21, it is
essential for making the life of the workman meaningful and purposeful with the
dignity of person. The right to health in all its forms and at all levels contains the
following interrelated and essential elements namely;
(i) Availability of public health and health-care facilities, goods and services,
(ii) Accessibility (both physical and economically affordability) to health facilities,
(iii) Acceptability of all health facilities, goods and services
(iv) Quality of services

The legislations focused on health care:

 The Indian Medical Council Act 1956 (Amended 1964, 1993 and 2001)
 The Drugs and Cosmetic Acts 1940
 The Indian Nursing Council Act 1947
 The Dentist Act 1948
 The Pharmacy Act 1948
 The Drugs (Control) Act 1948

 Approach of judiciary in right to health

The Indian Judiciary has made an extensive use of the constitutional provisions
and developed a new jurisprudence in the protection of public health and sanitation.

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
Supreme Court through Justice Krishna Iyer observed: “The State will realize that

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
Article 47 makes it a paramount principle of governance that steps are taken for the
improvement of public health as amongst its primary duties.”

In CESC Ltd. vs. Subash Chandra Bose, Supreme Court held that, “The term
health implies more than an absence of sickness. Medical care and health facilities
not only protect against sickness but also ensure stable manpower for economic
development. Facilities of health and medical care generate devotion and dedication
to give the workers’ best, physically as well as mentally, in productivity. It enables the
worker to enjoy the fruit of his labour, to keep him physically fit and mentally alert for
leading a successful economic, social and cultural life. Health is thus a state of
complete physical, mental and social well-being and not merely the absence of
disease or infirmity.

In T. Ramakrishna Rao vs. Hyderabad Development Authority, the Andhra


Pradesh High Court observed, Protection of the environment is not only the duty of
the citizens but also the obligation of the State and it’s all other organs including the
Courts. Environment Pollution is linked to Health and is violation of right to life with
dignity.

In State of Punjab vs. Ram Lubhaya Bagga, though the Supreme Court observed
that the State had an obligation to provide health care facilities to government
employees and to citizens, the obligation was only to the extent of its financial
resources for fulfilling the obligation.

In Common Cause vs. Union of India the Supreme Court laid down guidelines
regarding operation of blood banks. The issue rose before the court was that the
deficiencies and shortcomings in collection, storage and supply of blood through
blood centres operating in the country could prove fatal.

In Dr. Tokugha Yepthomi vs. Appollo Hospital and Anr, the Apex court held that,
the timely disclosure of the HIV positive status of the patient to his fiancée saved her
from being contracted with HIV and hence the disclosure did not invade the right to
privacy.

 Right to Emergency medical care


The massive population growth has created scarcity in essentials required by a
citizen to live with dignity and respect as mandated under Article 21 of the
Constitution of India. However, Emergency Medical Aid facility also being a
requirement under the right to life cannot be denied, and a citizen deprived of other
necessities should be at least guaranteed that.

 The Supreme Court has repeatedly emphasised to the government and other
authorities for focusing and giving priority to the health of its citizens. To secure
protection of one's life has been declared to be one of the foremost obligations of

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
the State. It is not merely a right enshrined under Article 21 but an obligation cast
on the State to provide this, both under Article 21 and under Article 47.

 A plethora of medical literature on the subject affirms that the ‘GOLDEN HOUR' is
the first hour in which ‘emergency medical care' is necessary and most victims
die if no such care is made available or is not provided soon.

 The purpose of emergency medical care is to ‘stabilise' the patient, and this,
unfortunately, is never followed.

Pt. Parmandand Katara vs. Union of India and Ors. In this case, a public-
spirited person has filed a Public Interest Litigation under Article 32 of the
Constitution of India, 1950.
The said petition was filed in response to a news report of a scooterist who was
knocked down by a car and died due to lack of medical treatment. Following the
accident, the scooterist was taken to the nearest hospital but was turned away
and sent to another hospital 20 km away, which was authorised to handle
medico-legal cases. The Hon'ble Apex court has held that it is the Right of the
Citizen and also the obligation on the State to preserve life and doctors at
government hospitals are therefore required to provide medical assistance to
preserve life.
In Paschim Banga Khet Mazdoor Samiti vs State of West Bengal where the
victim, an agricultural labour, who fell from a train and was denied emergency
medical aid in 5 public hospitals and ultimately was admitted in a private hospital
where he had to pay an exorbitant amount. Supreme Court has held that
preservation of human life is utmost important because if timely medical care is
not provided to the victim it may cause his death or leave him permanently
paralysed. Hence it is the fundamental right of the citizens to be provided with
emergency medical care without any condition.

Indian Medical Association vs V. P. Shanta, the Supreme Court of India finally


decided this issue and held that the patients who avail medical care are included
under the definition of the “Consumer” and healthcare is defined as “Service” as
per the Consumer Protection Act. Though incorporating healthcare services
under the scope of the Consumer Protection Act does not serve the purpose
because there are times when the patient has no guardian to look after and
requires emergency medical care. This results in a denial of emergency medical
care.

Conditions which call for emergency medical care are generally:


1. Accidents
2. Road accidents /Rail accidents
3. Collapses
4. Natural calamities
5. Delivery
6. Bites

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
7. Cardiac or coronary attacks.

Conclusion:
Though the life and liberty of a person are very much protected under Part III of the
Constitution (under Art. 21), and though there are appropriate directions passed by
the Hon'ble Supreme Court that in all accident and emergency cases irrespective of
any reasons, it is the fundamental duty of the hospitals to attend the patients and
ensure their safety and well- being, unfortunately, the said directions are not
complied and are being brazenly brushed off.

 Regulation of Public health care system

The need for an efficient and effective public health system in India is large.
Indian healthcare system has been historically dominated by provisioning of medical
care and neglected public health.

There are multiple systems set up in rural and urban areas of India including
Primary Health Centres, Community Health Centres, Sub Centres, and Government
Hospitals. These programmes must follow the standards set by Indian Public Health
Standards documents that are revised when needed.

In modern-day India, the spread of communicable diseases is under better control


and now non-communicable diseases, mostly like cardiovascular diseases, are
major killers. Health care reform was prioritized in the 1946 Bhore Committee Report
which suggested the implementation of a health care system that was financed at
least in part by the Indian government.

In 1983 the first National Health Policy (NHP) of India was created with the goals
of establishing a system with primary-care facilities and a referral system. In 2002,
the updated NHP focused on improving the practicality and reach of the system as
well as incorporating private and public clinics into the health sphere. In the context
of universal health coverage, the recent policy focus in India, there is an attempt to
ensure that every citizen should have adequate access to curative care without any
financial hardships.

Facilities

The healthcare system is organised into primary, secondary, and tertiary levels. At
the primary level are Sub Centres and Primary Health Centres (PHCs). At the
secondary level there are Community Health Centres (CHCs) and smaller Sub-
District hospitals. Finally, the top level of public care provided by the government is
the tertiary level, which consists of Medical Colleges and District/General Hospitals.

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
(i) Sub Centres: - A Sub Centre is designed to serve extremely rural areas with
the expenses fully covered by the national government.
(ii) Primary Health Centres: - Patients can be referred from local sub centres to
PHCs for more complex cases. A major difference from Sub Centres is that
state governments fund PHCs, not the national government. PHCs also
function to improve health education with a larger emphasis on preventative
measures.
(iii) Community Health Centres: - A Community Health Centre is also funded by
state governments and accepts patients referred from Primary Health
Centres. Patients from these agencies can be transferred to general hospitals
for further treatments. Thus, CHC's are also first referral units, or FRUs,
which are required to have obstetric care, new born/childcare, and blood
storage capacities at all hours everyday of the week.

(iv) District Hospitals: - District Hospitals are the final referral centres for the
primary and secondary levels of the public health system. These district
hospitals often lack modern equipment and relations with local blood banks.

Drawbacks

Drawbacks to India's healthcare system today include low quality care, corruption,
unhappiness with the system, a lack of accountability, unethical care, overcrowding
of clinics, poor cooperation between public and private spheres, barriers of access to
services and medicines, lack of public health knowledge, and low cost factor. These
drawbacks push wealthier Indians to use the private healthcare system, which is less
accessible to low-income families, creating unequal medical treatment between
classes.

(i) Low quality care: Low quality care is prevalent due to misdiagnosis, under
trained health professionals, and the prescription of incorrect medicines.
Public doctors feel less responsibility to treat their patients effectively than
do doctors in private clinics. Impolite interactions from the clinic staff may
lead to less effective procedures.

(ii) Corruption: India's public healthcare system pays salaries during absences,
leading to excessive personal days being paid for by the government.

(iii) Overcrowding of clinics: Sometimes patients are referred from rural areas to
larger hospitals, increasing the overcrowding in urban cities. Overcrowding
also increases the likelihood of diseases spreading, particularly in urban,
crowded areas of cities. Improper sanitation and waste disposal, even within
clinics, can lead to an increased incidence of infectious diseases.

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
 Private health care systems
The private health care sector has grown significantly over time. The growth of
this sector has been further triggered by a number of factors, including a liberalized
economic policy, rapid influx of medical technology, growing deficits of public sector
hospitals, and a rising middle income class. Its growth has profound implications for
the existing character of the Indian health care system and its future course.

Facilities and providers


The growth in the number of hospitals and hospital bed capacity in the private sector
is quite visible. During last 10 years, the number of hospitals has doubled and bed
capacity has grown more than 50 percent.
However, it should be noted that the number of hospitals, dispensaries and doctors
operating in the private sector is in fact much larger. There are large numbers of
institutions in the private sector, including the nursing homes and private clinics,
which have not been recorded in these health statistics.
The structure of the health care system in India is complex and it includes various
types of providers. These providers practice in different systems of medicines and
facilities.
The providers and facilities in India can be broadly classified by using three
dimensions:
 ownership styles (public, not-for-profit, and for-profit);
 systems of medicine (allopathic, homeopathic, and traditional)
 types of organization (hospitals, dispensaries, and clinics)

Regulations
The central and state governments in India have promulgated several pieces of
legislation to safeguard the health of population. The existing set of regulations
related to health care can be broadly divided into following three categories:
a. Drugs Related
b. Practice Related
c. Facilities Related

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
 Health care delivery system In India

The Indian health care system comprises private owned hospitals, health
personnel, medical colleges, program manager, etc. The health care system consists
of all the actions and individual whose main function is to provide quality health care
services and to improve health status.

One of the main reasons why people rely more on private health care providers
rather than public health care providers is that the public healthcare sector offers
poor quality of care. The reason for the poor-quality care of the public health care
system is the distance of primary health centers (PHCs), community health centers
(CHCs), and 26 sub-centers (SCs). Indian health care system disappointed Indians
especially rural people at various levels. Although the Indian health care system
consists or has the best technologies and doctors, it still faces the lack of
infrastructure in terms of PHCs, CHCs, and SCs.

 The healthcare infrastructure in India consists of primary, secondary, and tertiary


health care. The healthcare at these levels is provided by both public and private
health care providers.

 At the primary level of health care, we include community health centres (CHCs),
Primary health centres (PHCs), and subcenters (SCs). While the sub-district
hospitals come under the category of secondary health care and the tertiary level
of health care includes the district hospitals and medical colleges.

 While states are responsible for the functioning of the health care delivery
system, Centre also has a responsibility towards the state's health care system in

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
the form of policy making, planning, assisting and providing adequate funds to
various provincial health authorities to implement national programs

 While national level health care system is guided by the Union Ministry of Health
and Family Welfare (MoHFW), there is a state department of Health and Family
Welfare in each state, headed by a state minister.

 Sub-centres (SC)
The SCs is the first interaction point between the primary health care and local
community. Sub-centres provides the basic healthcare facilities to the people and
services in relation to the mother and child care (MCH), safe delivery, universal
immunization programme, family welfare services, primary medical care, control of
communicable and non-communicable diseases programmes.
 Primary Health Centre (PHC)
Primary Health Centre (PHC) is the first interaction point between the medical
officer and village community.

 Community Health Centers (CHC’S)


A CHC is to be manned by four medical officers specialized in surgeon,
physician, gynaecologist, and paediatrician with 21 paramedical officers and
other staff. As per the IPHS norms, a CHC should have at least 30 beds, x-ray
machine, Operation Theatre, delivery room and labs.

 Secondary Health care


In India, secondary healthcare includes district hospitals and community health
centres at the block level. Secondary Health Care system consists of Sub Divisional
Hospitals, District Hospitals, and Mobile Medical Units.
 Tertiary Health Care

At the tertiary health care, specialized preventive care is given to the patients
usually on referral from primary and secondary health care centres. Tertiary health
care includes medical colleges and advanced medical research institutes. Tertiary
health care center is a healthcare center within which medical education and
research take place. Patients would be referred to the tertiary health care centres in
case of insufficient treatment and referred back to the primary and secondary health
care centers after getting treatment at tertiary health care centers.

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
 Allopathy

Allopathic medicine, or allopathy, refers to science-based, modern medicine.


Among homeopaths and other alternative medicine advocates, "allopathic medicine"
now refers to "the broad category of medical practice that is sometimes called
Western medicine, biomedicine, evidence-based medicine, or modern medicine."

The term "allopathy" was coined in 1810 by Samuel Hahnemann (1755-1843) to


designate the usual practice of medicine (allopathy) as opposed to homeopathy, the
system of therapy that he founded. Homeopathy is based on the concept that
disease can be treated with minute doses of drugs thought capable of producing the
same symptoms in healthy people as the disease itself. Although allopathic
medicine" was rejected by mainstream physicians, it was adopted by alternative
medicine advocates to refer pejoratively to conventional medicine

As used by homeopaths, the term allopathy has always referred to the principle of
treating disease by administering substances that produce other symptoms (when
given to a healthy human) than the symptoms produced by a disease. For example,
part of an allopathic treatment for fever may include the use of a drug which reduces
the fever, while also including a drug (such as an antibiotic) that attacks the cause of
the fever (such as a bacterial infection). A homeopathic treatment for fever, by
contrast, is one that uses a diluted dosage of a substance that in an undiluted form
would induce fever in a healthy person. These preparations are typically diluted so
heavily that they no longer contain any actual particles of the original substance.

Most modern science-based medical treatments (antibiotics, vaccines, and


chemotherapeutics, for example) do not fit Samuel Hahnemann's definition of
allopathy, as they seek to prevent illness, or remove the cause of an illness by acting
on the cause of disease.

Homeopathy

 Homeopathy or homoeopathy is a pseudoscientific system of alternative


medicine. It was created in 1796 by the German physician Samuel Hahnemann.
 Its practitioners, called homeopaths, believe that a substance that causes
symptoms of a disease in healthy people would cure similar symptoms in sick
people; this doctrine is called similia similibus curentur, or "like cures like".
 Homeopathic preparations are termed remedies and are made
using homeopathic dilution. In this process, a chosen substance is repeatedly
and thoroughly diluted. The final product is chemically indistinguishable from the
diluent, which is usually either distilled water, ethanol or sugar; often, not even a
single molecule of the original substance can be expected to remain in the
product. Practitioners claim that such preparations, upon oral intake, can treat or
cure disease.
 Hahnemann believed that large doses of drugs that caused similar symptoms
would only aggravate illness, he advocated extreme dilutions of the substances;

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
he devised a technique for making dilutions that he believed would preserve a
substance's therapeutic properties while removing its harmful
effects. Hahnemann believed that this process aroused and enhanced "the spirit-
like medicinal powers of the crude substances".

 It’s used for a wide variety of health issues, including some chronic illnesses:

 Allergies
 Migraines
 Depression
 Chronic fatigue syndrome
 Rheumatoid arthritis
 Irritable bowel syndrome
 Premenstrual syndrome

It can also be used for minor issues like bruises,


scrapes, toothaches, headaches, nausea, coughs, and colds. It should not be used for
life-threatening illness, like asthma, cancer, heart disease. Should not be used as a
vaccine. Vaccines called “nosodes” are not proven to be effective.

 The FDA oversees homeopathic remedies. But it doesn’t check to see if they’re
safe or effective. In general, most are so watered down that they don’t cause any
side effects. But there are exceptions. Homeopathic medicines can contain a
large amount of an active ingredient, like a heavy metal, that can be dangerous.

Unani and applied systems


 Unani system of medicine is a great healing art as well as science. It treats a
person as a whole not as a group of individual parts. It is aimed at treating body,
mind and soul. This system is based on Hippocratic theory of four humors viz.
blood, phlegm, yellow bile and black bile.
 The World Health Organization (WHO) has recognized the Unani System of
Medicine (USM) as an alternative system to cater the health care needs of
human population. Unani is one of the most well-known traditional medicine
systems in China, Egypt, India, Iraq, Persia and Syria.
 India has accepted it as one of the alternative health care system and has given it
official status.
 Similar to Ayurvedic medicine, Unani medicine also recommends daily use of
therapeutic procedures like chewing sticks for brushing of teeth in the morning as
well as after every meal for the prevention and maintenance of oral health.
 However, since most of the drugs which have been described in Unani material
medica and are widely used by the physicians of Unani medicine in the treatment
of dental diseases have still not been studied scientifically for their claimed
effects. Therefore, there is an element of doubt regarding their efficacy and safety
that can only be removed by scientific validation.
 There are 7 principles on the unani doctrine. these principles include (1) arkan, or
elements, (2) mizaj, or temperament,

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
(3) akhlat, or bodily humours, (4) aaza, or organs and systems, (5) arwah, or vital
spirit, (6) quwa, or faculties or powers, and (7) afaal, or functions. Interacting with
each other, these seven natural components maintain the balance in the natural
constitution of the human body.
 There are several therapeutic approaches, Ilaj-bi-dawa, or pharmacotherapy, is
the use of medicines by Unani hakims. This treatment method is considered by
hakims to be natural, eco-friendly, and less intrusive and more effective than
many other methods. The Unani system’s pharmacopoeia is vast, enriched with
more than 2,000 medicines derived from various herbal, mineral, and animal
sources.
 Obstacles of unani medicine: the use in Unani medicine of precious stones and
minerals, the chief ingredients of many poly formulations (medicines containing
multiple ingredients), is expensive. Those items often are unavailable as well,
thereby hindering effective treatment.

Ayurveda
 Ayurveda, a natural system of medicine, originated in India more than 3,000
years ago. The term Ayurveda is derived from the Sanskrit words ayur (life) and
veda (science or knowledge). Thus, Ayurveda translates to knowledge of life.
 Ayurveda places great emphasis on prevention and encourages the maintenance
of health through close attention to balance in one’s life, right thinking, diet,
lifestyle and the use of herbs.
 According to Ayurvedic philosophy the entire cosmos is an interplay of the
energies of the five great elements—Space, Air, Fire, Water and Earth.
 Vata, pitta and kapha are combinations and permutations of these five elements
that manifest as patterns present in all creation. In the physical body, vata is the
subtle energy of movement, pitta the energy of digestion and metabolism, and
kapha the energy that forms the body’s structure.
 The goal of treatment is to cleanse your body of undigested food, which can stay
in your body and lead to illness. The cleansing process—called “panchakarma”—
is designed to reduce your symptoms and restore harmony and balance. To
achieve this, an Ayurvedic practitioner might rely on blood purification, massage,
medical oils, herbs, and enemas or laxatives.
 Ayurvedic treatments improve digestion and increase appetite and immunity.
 The basic principles of Ayurveda constitute the following disciplines – don’t skip
breakfast, eat a light dinner, avoid sleeping and waking up late, drink water, eat
organic produce, avoid smoking and drinking, and maintain an active lifestyle.

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
Module 3
Medical profession and law

 Medical ethics
Medical ethics is based on a set of values that professionals can refer to in the
case of any confusion or conflict. These values include the respect for autonomy,
non-maleficence, beneficence, and justice. Such tenets may allow doctors, care
providers, and families to create a treatment plan and work towards the same
common goal.
There are several codes of conduct. The Hippocratic Oath discusses basic
principles for medical professionals. The Declaration of Helsinki (1964) and The
Nuremberg Code (1947) are two well-known and well-respected documents
contributing to medical ethics.
The field of medical ethics encompasses both practical application in clinical
settings and scholarly work in philosophy, history, and sociology.

 Professional Values
A common framework used in the analysis of medical ethics is the "four principles"
approach postulated by Tom Beauchamp and James Childress in their
textbook Principles of biomedical ethics. It recognizes four basic moral principles:
 Principle for autonomy – the patient has the right to refuse or choose their
treatment.
 Principle of Beneficence – a practitioner should act in the best interest of the
patient.
 Principle of Non-maleficence – to not be the cause of harm. Also, "Utility" –
to promote more good than harm
 Principle of Justice – concerns the distribution of scarce health resources,
and the decision of who gets what treatment.
 Autonomy
The principle of autonomy, "autos" (self) and "nomos (rule), views the rights of an
individual to self-determination. This is rooted in society's respect for individuals'
ability to make informed decisions about personal matters with freedom.
The definition of autonomy is the ability of an individual to make a rational,
uninfluenced decision. Therefore, it can be said that autonomy is a general indicator
of a healthy mind and body.
Persons lacking mental capacity are treated according to their best interests. This
will involve an assessment involving people who know the person best to what
decisions the person would have made had they not lost capacity.

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
 Beneficence
The term beneficence refers to actions that promote the well being of others. In the
medical context, this means taking actions that serve the best interests of patients
and their families. However, uncertainty surrounds the precise definition of which
practices do in fact help patients.
 Non-maleficence
The concept of non-maleficence is embodied by the phrase, "first, do no harm," or
the Latin, primum non nocere. That it is more important not to harm your patient,
than to do them good, which is part of the Hippocratic oath that doctors take.
Much harm has been done to patients as a result, as in the saying, "The treatment
was a success, but the patient died." It is not only more important to do no harm than
to do good; it is also important to know how likely it is that your treatment will harm a
patient. So a physician should go further than not prescribing medications they know
to be harmful—he or she should not prescribe medications (or otherwise treat the
patient) unless s/he knows that the treatment is unlikely to be harmful; or at the very
least, that patient understands the risks and benefits, and that the likely benefits
outweigh the likely risks.
 Double effect
Double effect refers to two types of consequences that may be produced by
a single action, and in medical ethics it is usually regarded as the combined
effect of beneficence and non-maleficence.
A commonly cited example of this phenomenon is the use of morphine or
other analgesic in the dying patient. Such use of morphine can have the
beneficial effect of easing the pain and suffering of the patient while
simultaneously having the maleficent effect of shortening the life of the patient
through the deactivation of the respiratory system.

 Justice

Justice in health care is usually defined as a form of fairness, or as Aristotle once


said, "giving to each that which is his due." This implies the fair distribution of goods
in society and requires that we look at the role of entitlement. The question of
distributive justice also seems to hinge on the fact that some goods and services are
in short supply, there is not enough to go around, thus some fair means of allocating
scarce resources must be determined.
It is generally held that persons who are equals should qualify for equal
treatment. This is borne out in the application of Medicare, which is available to all
persons over the age of 65 years. This category of persons is equal with respect to
this one factor, their age, but the criteria chosen says nothing about need or other
noteworthy factors about the persons in this category. In fact, our society uses a
variety of factors as criteria for distributive justice, including the following:

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
1. To each person an equal share
2. To each person according to need
3. To each person according to effort
4. To each person according to contribution
5. To each person according to merit
6. To each person according to free-market exchanges

 Patient’s rights
The Ministry of Health and Family Welfare (MoHFW) has recently released a
‘Charter of Patients Rights’ that compiles the lawful rights as stated in the
Constitution of India.

1. Right to information

 Physicians or their qualified assistants are required to provide adequate


information about your illness, its diagnosis (provisional or confirmed, as it may
be), proposed investigation and possible complications to the patient. If the
patient is not in a state to understand this, the physician or their assistant is
required to provide the information to the caretaker.
 This has to be done in a simple language that the patient or caretaker will
understand.
 Apart from this, patients have the right to know the identity and professional
status of every doctor and assistant as well as the primary doctor who is treating
them.
 Information regarding costs of treatment needs to be given in writing.

2. Right to records and reports

 Patients or their respective caretakers have the right to access the originals or
copies of case papers, indoor patient records and investigation reports.
Investigation reports have to be made available to them within 24 hours of
admission or 72 hours of discharge.
 The hospital is responsible for providing a discharge summary or a death
summary, in the case of a death, to the caretakers or kin of the patient with
original copies of investigations.
 Electronic medical records (EMR) – they are the digital equivalent of paper
records, or charts at a clinician’s [Link] typically contain general information
such as treatment and medical history about a patient as it is collected by the
individual medical practice.
 Electronic medical records improve quality of care, patient outcomes, and safety
through improved management, reduction in medication errors, reduction in
unnecessary investigations, and improved communication and interactions
among primary care providers, patients, and other providers involved in care.

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
 Perhaps the most significant benefit is that EMR records are universal, meaning
that instead of having different charts at different healthcare facilities, a patient
will have one electronic chart that can be accessed from any healthcare facility
using EMR software.
 EMR software systems will provide links to articles, videos, and images that can
help patients better understand their specific healthcare situation. With this
technology, patients can make more informed decisions about medical
procedures and lifestyle adjustments.
 Using EMR systems, patients can quickly and easily receive electronic copies of
their healthcare information upon request.

3. Right to emergency medical care

In an emergency situation, you can avail medical care in any government or


private hospital. Under Article 21 of the Constitution, which ensures that every
person has the right to life and personal liberty, you have the right to prompt
emergency care by doctors without compromise on quality or safety and without
having to pay full or an advanced fee to the hospital.

4. Right to informed consent


Informed consent in ethics usually refers to the idea that a person must be fully
informed about and understand the potential benefits and risks of their choice of
treatment.
An uninformed person is at risk of mistakenly making a choice not reflective of
his or her values or wishes. It does not specifically mean the process of obtaining
consent, or the specific legal requirements, which vary from place to place, for
capacity to consent.
Patients can elect to make their own medical decisions or can delegate
decision-making authority to another party. If the patient is incapacitated, laws
around the world designate different processes for obtaining informed consent,
typically by having a person appointed by the patient or their next of kin make
decisions for them. The value of informed consent is closely related to the values
of autonomy and truth telling. In emergency cases, the consent of patient is not a
mandatory ethic.
In Dr. T.T. Thomas vs. Elisa, the patient was admitted to the hospital with a
severe case of perforated appendix. The doctors refused to operate on the
patient, as they did not get the patients consent and the patient died after 3 days.
The court held that in emergency operations where a doctor cannot wait for the
consent of his patient or where the patient is not in a fit state of mind to give or
not to give a conscious answer regarding consent.

5. Right to confidentiality, human dignity and privacy

 Confidentiality is commonly applied to conversations between doctors and


patients. This concept is commonly known as patient-physician privilege.
Legal protections prevent physicians from revealing their discussions with
patients, even under oath in court.

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
 the code of ethics dictates doctors to hold information about the illness and
treatment plan for the patient in strict confidentiality from everyone except the
patient and their caretakers.
 Unless it is an exceptional case where sharing this information is “in the interest of
protecting other or due to public health considerations.”

6. Right to non-discrimination

 Rights of a patient being upheld without discrimination based on their illness,


condition, HIV status or on their gender, age, religion, caste, ethnicity, sexual
orientation, linguistic or geographical or social origins.
 Based on the above characteristics, no person can be subjected to discriminatory
treatment, and the staff of the hospital is responsible for ensuring this.

7. Right to safety and quality care according to standards

 Safety and security.


 Cleanliness, infection control measures and sanitation facilities and safe drinking water.
 Healthcare that abides by the latest standards, norms and guidelines under the National
Accreditation Board for Hospitals (NABH).
 To be attended to, treated and cared for in a professional manner and with the principles of
medical ethics.
 Right to seek redressal by patient or caretakers.

8. Right to choose alternative treatment options if available

 After a thorough study of treatment choices, the patient/caretakers can choose to opt for a
treatment that may or may not be the doctor’s primary recommendation.
 This also means that once the patient/caretakers choose this alternative treatment, they
will shoulder the responsibility of its consequences.

9. Right to a second opinion

Doctors and the hospital must respect your decision if you choose to seek a second
opinion from a doctor/hospital of your choice.

10. Right to transparency in rate and care according to prescribed rates wherever
relevant

the patient has the right to have a written account of the costs they will have to bear for
the treatment they are receiving.

11. Right to choose the source for obtaining medicines or tests

As a patient or a caretaker, you have the right to choose which registered


pharmacy you wish to buy your medical supplies from. This also includes getting
an investigation procedure (like a blood test, for example) from any diagnostic

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
centre or laboratory registered under the National Accreditation Board for
Laboratories (NABL).

12. Right to protection for patients involved in clinical trials

According to the MoHFW, “All clinical trials must be conducted in compliance with
the protocols and Good Clinical Practice Guidelines issued by Services, Govt. of
India as well as all applicable statutory provisions of Amended Drugs and Cosmetics
Act, 1940 and Rules, 1945 Central Drugs Standard Control Organisation, Directorate
General of Health.” These points include consent by the patient, written prescription
of drugs or intervention, privacy etc.

13. Rights to protection of participants involved in biomedical and health


research

 In case a patient is involved in a biomedical or health research procedure, their


consent needs to be taken in a written format. Their right to dignity, privacy and
confidentiality needs to be upheld even during the research. If the participant
suffers direct physical, psychological, social, legal or economic harm, they are
eligible for financial or other assistance by the hospital.
 Whatever benefits the hospital gets from the research must be made available to
relevant individuals, communities and the general population.

14. Right to be heard and seek redressal

 Last but not the least, every patient has the right to address his grievances and
give feedback about the healthcare and treatment they received at the hospital or
from a particular doctor/assistant.

 Regulation of medical profession


The Medical Council of India (MCI) was a statutory body for establishing uniform
and high standards of medical education in India till 25 September 2020. On 25
September 2020 it was replaced by National Medical Commission. The Council
grants recognition of medical qualifications, gives accreditation to medical schools,
grants registration to medical practitioners, and monitors medical practice in India.
Functions of the council
 Establishment and maintenance of uniform standards for undergraduate
medical education.
 Regulation of postgraduate medical education in medical colleges accredited
by it. (The National Board of Examinations is another statutory body for
postgraduate medical education in India).
 Recognition of medical qualifications granted by University or UGC in medical
institutions in India.
 Recognition of foreign medical qualifications in India.

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
 Accreditation of medical colleges.
 Registration of doctors with recognized medical qualifications. The state
medical councils maintains the register of doctors registered in each state
which is then forward to the Medical council each quarter for updation in the
national register. However, Foreign medical graduates have the option to
directly register at the MCI.
 Keeping a directory of all registered doctors (called the Indian Medical
Register).
 Making necessary amendments in the regulation related to medical education
and practices.

 Medical negligence
Medical Negligence basically is the misconduct by a medical practitioner or doctor
by not providing enough care resulting in breach of their duties and harming the
patients which are their consumers. Negligence is an offense under tort, IPC, Indian
Contracts Act, Consumer Protection Act and many more.
Negligence is the omission to do an act , and as a result causes harm.

In King v. Phillips it was observed that the question of negligence arises only
when there is a direct harm to the plaintiff by the misconduct and the harm should
be foreseeable. Damage is an important ingredient to bring negligence under tort.

 Negligence as a Tort
A tort is a residuary civil wrong. Duties in tort are fixed by the law and such
duties are owed in rem or to the people at large generally. Such wrongs can be
remedied by filing for unliquidated damages. For instance, if there is a contract
existing between a patient and a doctor, then the doctor, for his negligence, will
be liable under contract.

 Negligence under Contract


A contract may have express or implied terms. There are situations where there
is a contract between medical practitioners and patients. Even in the absence of
an express stipulation to the effect that the practitioner will exercise reasonable
skill and care in treatment of a patient, it is taken as an implied duty arising out of
the contract. Breach of this duty thus results in violation of the contract.

 Negligence as a crime
Negligence under tort is determined on the extent of the loss caused whereas
negligence under criminal law is dependent on the degree or amount of
negligence. the element of criminality is introduced not only by a guilty mind, but
by the practitioner having run the risk of doing something with recklessness and
indifference to the consequences. It should be added that this negligence or
rashness or must be ‘gross’ in nature.

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
 Negligence under consumer protection legislations
Under consumer protection laws, medical negligence is another form of
deficiency in service. Admittedly, doctors have an extremely difficult duty to
perform. They are the ones in whose hands a patient places what is most
valuable to each human – their lives. It is for this reason that doctors are
expected to exercise a very high degree of skill and care, but this is also the
precise reason why they should not be inhibited in the exercise of their duty.
Therefore, the laws imposing liability on medical practitioners have been tailored
to accord to practitioner’s maximum possible protection.

The conduct of medical malpractice was brought under the Consumer Protection
Act, 1986, due to the landmark case of the Indian Medical Association vs. V.
P. Shantha & others, The judgment in this case defined medical care as a
“service” that was covered under the Act, and also clarified that a person seeking
medical attention may be considered a consumer if certain criteria were met.

 Negligence by professionals
The SC in Jacob Mathew v. State of Punjab, explained: a professional
entering into certain profession is deemed to have knowledge regarding that
profession and it is assured impliedly by him that a reasonable amount of care
shall be taken to profess his profession. The person can be held liable under
negligence if he did not possess the required skills to profess or he failed to take
essential amount of care to profess the said profession.

 Doctor’s duty to attend the patient


A doctor or a medical practitioner when attends to his patients, owes him the
following duties of care:
1. A duty of care in deciding whether to undertake the case
2. A duty of care in deciding what treatment to give
3. A duty of care in the administration of the treatment

In Sishir Rajan Saha v. The state of Tripura that if a doctor did not pay enough
attention to the patients in government hospitals as a result of which the patient
suffers, the doctor can be held liable to pay compensation to the patient.
 Liability
The liability of the person committing the wrong can be of three types
depending on the harm or the injury suffered by the injured person they are:
1. Civil Liability– Civil liability usually includes the claim for damages suffered in
the form of compensation. If there is any breach of duty of care while operating or
while the patient is under the supervision of the hospital or the medical
professional, they are held to be vicariously liable for such wrong committed. And
are liable to pay damages in the form of compensation.

In Mr. M Ramesh Reddy v. State of Andhra Pradesh, the hospital authorities


were held to be negligent, inter alia, for not keeping the bathroom clean, which

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
resulted in the fall of an obstetrics patient in the bathroom leading to her death. A
compensation of Rs. 1 Lac was awarded against the hospital.

2. Criminal Liability- There may be an occasion when the patient has died after the
treatment and criminal case is filed under Section 304A of the Indian Penal Code
for allegedly causing death by rash or negligent act. According to S. 304A of the
IPC, whoever causes the death of any person by a rash or negligent act not
amounting to culpable homicide shall be punished by imprisonment for up to two
years, or by fine, or both.

3. In Dr. Suresh Gupta’s Case – Supreme Court of India, 2004 – the court held
that the legal position was quite clear and well settled that whenever a patient
died due to medical negligence, the doctor was liable in civil law for paying the
compensation. Only when the negligence was so gross and his act was as
reckless as to endanger the life of the patient, criminal law for offence under
section 304A of Indian Penal Code, 1860 will apply. IPC sections 52, 80, 81, 83,
88, 90, 91, 92 304-A, 337 and 338 contain the law of medical malpractice in
India.

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
Module 4
Right to health of Vulnerable groups
Certain groups in the society often encounter discriminatory treatment and need
special attention to avoid potential exploitation. This population constitutes what is
referred to as Vulnerable Groups.

Vulnerable groups are disadvantaged as compared to others mainly on account of


their reduced access to medical services and the underlying determinants of health
such as safe and potable drinking water, nutrition, housing, sanitation etc.

 Women

Women face double discrimination being members of specific caste, class or ethnic
group apart from experiencing gendered vulnerabilities. Women have low status as
compared to men in Indian society. They have little control on the resources and on
important decisions related to their lives. In India, early marriage and childbearing
affects women’s health adversely.

 Maternal mortality is very high in India. The average maternal mortality ratio at
the national level is 540 deaths per 100,000 live births (National Family Health
Survey-2, 2000).

 A large proportion of women is reported to have received no antenatal care. In


India, institutional delivery is lowest among women from the lower economic
class as against those from the higher class.

 Women face violence and it has an impact on their health. During infancy and
growing years a girl child faces different forms of violence like infanticide, neglect
of nutrition needs, education and healthcare. As adults they face violence due to
unwanted pregnancies, domestic violence, sexual abuse at the workplace and
sexual violence including marital rape and honor killings. The experience of
violence and its impact on health varies according to the women’s caste, class
and ethnic identity.

 Tribal

The Scheduled Tribes like the Scheduled Castes face structural discrimination within
the Indian society. Unlike the Scheduled Castes, the Scheduled Tribes are a product
of marginalization based on ethnicity.
 In India, the Scheduled Tribes population is around 84.3 million and is considered
to be socially and economically disadvantaged. Their percentages in the
population and numbers however vary from State to State.

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
 They are mainly landless with little control over resources such as land, forest
and water. They constitute a large proportion of agricultural labourers, casual
labourers, plantation labourers, industrial labourers etc. This has resulted in
poverty among them, low levels of education, poor health and reduced access to
healthcare services.

 They belong to the poorest strata of the society and have severe health
problems. They are less likely to afford and get access to healthcare services
when required.

 The health outcomes among the Scheduled Tribes are very poor even as
compared to the Scheduled Castes.

 The Infant Mortality Rate among Scheduled Castes is 83 per 1000 live births
while it is 84.2 per 1000 per live births among the Scheduled Tribes.

 Among the Scheduled Castes and the Scheduled Tribes the most vulnerable are
women, children, aged, those living with HIV/AIDS, mental illness and disability.
These groups face severe forms of discrimination that denies them access to
treatment and prevents them from achieving a better health status.

 Gender based violence and domestic violence is high among women in general
in India. Girl child and women from the marginalized groups are more vulnerable
to violence. The dropout and illiteracy rates among them are high. Early
marriage, trafficking, forced prostitution and other forms of exploitation are also
reportedly high among them. In situations of caste conflict, women from
marginalized groups face sexual violence from men of upper caste i.e, rape and
other forms of mental torture and humiliation.

 Children

Children and the elderly population face different kind of vulnerability. Mortality
and morbidity among children are caused and compounded by poverty, their sex and
caste position in society. All these have consequences on their nutrition intake,
access to healthcare, environment and education. These factors directly impacts
food security, education of parents and their access to correct health information and
access to health care facilities. Malnutrition and chronic hunger are the important
causes of death among children from poor families. Diarrhoea, acute respiratory
diseases, malaria and measles are some of the main causes of death among
children, most of which are either preventable or treatable with low-cost
interventions.
 The vaccination coverage is very poor among children who live in rural India.

 There is a large proportion of children in India who are living with HIV/AIDS. The
most common sources of infection among children is the Mother-to-Child

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
Transmission (MCTC), sexual abuse, blood transfusion, unsterilised syringes,
including injectable drug use.

 A large number of children are reportedly trafficked to the neighbouring countries.


Trafficking of children also continues to be a serious problem in India. The nature
and scope of trafficking range from industrial and domestic labour, to forced early
marriages and commercial sexual exploitation.

 Elderly

 In India, the population of the elderly is growing rapidly and is emerging as a


serious area of concern for the government and the policy planners.

 The vulnerability among the elderly is not only due to an increased incidence of
illness and disability, but also due to their economic dependency upon their
spouses, children and other younger family members.

 Vulnerability among the elderly also depends on their living arrangement since
the elderly are less capable of taking care of themselves compared to younger
persons and need the care and support of others in several aspects.

 Lack of economic dependence has an impact on their access to food, clothing


and healthcare. Among the basic needs of the elderly, medicine features as the
highest unmet need.

 Among the elderly, the widows, poor and disabled constitute those who are more
disadvantaged.

 At all India level, aged women like those in other age groups suffer from lack of
ownership of property and financial assets and participation in their management
compared to aged men in both urban and rural India.

 Disability

 Disability poses greater challenges in obtaining the needed range of services.


Persons with disabilities face several forms of discrimination and has reduced
access to education, employment and other socioeconomic opportunities. In
India, there is an increase of proportion of disabled population.

 There are two broad categories of disability, one is acquired which means
disability acquired because of accidents and medical reasons the other is
disability since the onset of birth.

 The disabled face various types of barriers while seeking access to health and
health services. There are different types of disability and the needs of the

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
disabled differ accordingly. Among those who are disabled women, children and
aged are more vulnerable and need attention.

 Mentally challenged

 Mental illness is a prominent form of disability. Five out of ten leading causes of
disability and premature death worldwide are due to psychiatric conditions.
Depression and anxiety are the most common mental disorders.

 The other area of concern is the mental health of women and the elderly.
Neurotic and stress related cases are reportedly higher among women than men
though among men there is reporting of higher number of cases of serious
illness.
 But in spite of such proportion of mental illness, the health care provisions for
persons with mental illness are very poor in India. People with mental illness face
severe forms of human rights violations.
 In Special Homes, Hospitals and Asylums, they are kept in chains, denied basic
needs like food, clothing and face different forms of abuse.

 There is social stigma attached to mental illness. Women with mental illness are
subjected to physical and sexual abuse both within families and the institutions.

 Psychiatric medicines are supplied only in a few primary health centres,


community centres and district hospitals.

 Services like child guidance and rehabilitative services are also available only in
mental hospitals and in big cities. Several states do not have mental hospitals.

 The Persons with Disabilities (Equal Opportunities, Protection of Rights and Full
Participation) Act 1995, commonly referred as the PWD Act came into force on
Feb. 7, 1996. Mental illness has been considered in the Act, but there is no
reference to any provision within the Act to be given or set aside for people with
mental illness. The Act also does not assure the right to treatment

 WHAT CONSTITUTES VIOLATION OF RIGHT TO HEALTH FOR VULNERABLE


GROUPS?

Violation of the right to health of vulnerable groups may result from direct
government action, from failure of the government to fulfil its minimum core
obligations and from the patterns of systematic discrimination. The specific examples
of violations of right to health of vulnerable groups would be:

 Deliberate withholding or misrepresentation of information on the health status of


disadvantaged groups that may have been essential for the prevention and
treatment of illness or disability.

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
 Imposing discriminatory practices affecting the group’s health status and
needs.
 Adopting laws and policies that interfere with the rights of the groups, for
example, women’s reproductive rights.
 Failure to protect women against violence; violence against women is often
systematic and serious enough to require women to seek hospital treatment
for injuries and involve other health complication related to violence. When
governments fail to take pre-emptive steps to prevent and treat victims of
violence it is tantamount to violation of right.
 Failure of government to provide adequate public health measures against
infectious diseases that affect the disadvantaged groups.
 Failure to cover the eligible population with child immunization packages.
 Failure to provide adequate obstetric and family planning services.
 Failure to provide adequate primary healthcare, basic healthcare service to
disadvantaged group.
 Government policies and practices creating imbalances in providing health
services, i.e., poor infrastructure in rural areas or predominantly tribal areas.
 Systematic discrimination in access to medicines and essential drugs for
particular groups, i.e., HIV/AIDS drugs, reproductive health services for
particular groups like women living in poverty, in rural areas, belonging to
marginalized communities.

 ADVOCACY ON HEALTH AND HUMAN RIGHTS OF VULNERABLE GROUPS IN


INDIA

 Identify disadvantaged/marginalized groups; their health status and needs in


different situations
 Review the health information and services that are available to protect the
health of the poor, vulnerable, or otherwise disadvantaged groups, including
their quality, accessibility, affordability and acceptability.
 Collect disaggregated information on the health disparities among the
marginalized groups. Identify the unmet need, particularly those resulting from
adverse discrimination.
 Assess the relevance of public health messages and determine whether they
are accessible and meaningful.
 Increase public awareness on the right to health of the vulnerable groups and
engage in community education and mobilization.
 Work on national enforcement procedures to ensure state accountability.

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
Module 5

Euthanasia
The British House of Lords select committee on medical ethics defines euthanasia
as "a deliberate intervention undertaken with the express intention of ending a life, to
relieve intractable suffering".
Euthanasia can be done in two ways:
 Passive euthanasia- death caused by withdrawing or withholding treatment
eg, switching off a machine that is keeping a person alive.
 Active euthanasia- it includes administration of lethal compounds for the
purpose of ending life.

Euthanasia is categorized in three kinds:


 Voluntary euthanasia is legal in some countries.
 Non-voluntary euthanasia (patient's consent unavailable) is illegal in all
countries.
 Involuntary euthanasia (without asking consent or against the patient's will)
is also illegal in all countries and is usually considered murder.

Since March 2018, passive euthanasia is legal in India under strict guidelines.
Patients must consent through a living will, and must be either terminally ill or in a
vegetative state.
On 9 March 2018 the Supreme Court of India legalised passive euthanasia by
means of the withdrawal of life support to patients in a permanent vegetative state.
The decision was made as part of the verdict in a case involving Aruna Shanbaug,
who had been in a Persistent Vegetative State (PVS) until her death in 2015.
The Supreme Court specified two irreversible conditions to permit Passive
Euthanasia Law in its 2011 Law:
(I) The brain-dead for whom the ventilator can be switched off
(II) Those in a Persistent Vegetative State (PVS) for whom the feed can be
tapered out and pain-managing palliatives be added, according to laid-
down international specifications.

 Aruna Shanbaug case

Aruna Shanbaug was a nurse working at the King Edward Memorial


Hospital, Parel, Mumbai. On 27 November 1973 she was strangled and sodomized
by Sohanlal Walmiki, a sweeper. During the attack she was strangled with a chain,
and the deprivation of oxygen has left her in a vegetative state ever since. She has
been treated at KEM since the incident and is kept alive by feeding tube. On behalf
of Aruna, her friend Pinki Virani, a social activist, filed a petition in the Supreme
Court arguing that the "continued existence of Aruna is in violation of her right to live

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
in dignity". The Supreme Court made its decision on 7 March 2011. The court
rejected the plea to discontinue Aruna's life support but issued a set of broad
guidelines legalising passive euthanasia in India. The Supreme Court's decision to
reject the discontinuation of Aruna's life support was based on the fact that the
hospital staff who treat and take care of her did not support euthanizing her. She
died from pneumonia on 18 May 2015, after being in a coma for a period of 42 years.

 Supreme court judgement

While rejecting Pinki Virani's plea for Aruna Shanbaug's euthanasia, the court
laid out guidelines for passive euthanasia. According to these guidelines, passive
euthanasia involves the withdrawing of treatment or food that would allow the
patient to live. Forms of active euthanasia, including the administration of lethal
compounds, legal in a number of nations and jurisdictions including
Luxemburg, Belgium and the Netherlands, as well as the US states
of Washington and Oregon, are still illegal in India.

India had no law about euthanasia, the Supreme Court's guidelines are law
until and unless Parliament passes legislation.[5] India's Minister of Law and
Justice, Veerappa Moily, called for serious political debate over the issue.[8] The
following guidelines were laid down:

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.

2. Even if a decision is taken by the near relatives or doctors or next friend to


withdraw life support, such a decision requires presence of two witness and
countersigned by first class judicial magistrate, and should also be approved by a
medical board set up by the hospital.

 Drug trials
 What is a clinical trial?

A clinical trial is defined as the systematic study of nee drugs in human subjects
to generate data for discovering and/or verifying:

 The clinical pharmacological (including pharmacodynamic and


pharmacokinetic) effects
 And/or adverse effects
 With the objective of determining safety and/or efficacy of the new drug

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
The Central Drugs Standard Control Organization (CDSCO) is the National
Regulatory Authority in India. CDSCO is an arm of the Ministry of Health and Family
Welfare, Government of India. Its mission is to safeguard and enhance public health
by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices.
The Drugs Controller General of India (DCGI) is an official of the CDSCO who is
the final regulatory authority for the approval of clinical trials in the country. His
ambit, in addition, also extends to inspections of trial sites, inspections of sponsors of
clinical research and manufacturing facilities in the country, oversight of the Central
Drugs Testing Laboratory (Mumbai) and the Regional Drugs Testing Laboratory as
also heading the Indian Pharmacopeia Commission among various other roles,
responsibilities and functions.

 Key documents in clinical research

1. Drugs and cosmetics Act (1940) and Drugs and Cosmetics Rules (1945)
This act first came into being in 1940 and regulates the import, manufacture
and distribution of drugs in the country to ensure that drugs and cosmetics sold in
the country are safe, effective and conform to essential quality standards.

2. Ethical Guidelines of the Indian Council of Medical Research (2006)


This guideline covers two broad aspects of clinical research – the general
principles that need to be followed and guidance regarding special areas of
research (e.g., research in children or herbal research). Researchers are
expected to be familiar with both these documents and abide by the requirements
in the former and the guidance in the latter.

 Assisted conceptions
Assisted conception refers to medical interventions used by fertility specialists
and clinics to help couples with fertility problems to conceive a baby.
There are many complex and varied treatments available to assist with conception
and scientific advances are being made all the time. Depending on the results
of fertility tests and if a cause is found treatments offered will depend on the
diagnosis of what is thought to cause the infertility. If a cause is not known, most
fertility specialists start with the simplest interventions and then progressively offer
more complex treatments if the initial approaches do not work. Often a combination
of different treatments is used.
1. Surgery
One or both partners may require an operation for a physical problem affecting their
fertility. This may be to repair or reconstruct a blocked duct that carries semen for the
man or to clear the woman's fallopian tubes called a tuboplasty.

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
Around 10% of men with fertility problems require surgical sperm retrieval or SSR.
This is because they have little or no sperm present in their ejaculate due to
blocked vas deferens ducts, but still produce healthy sperm in their testes.

2. Artificial insemination
Artificial insemination of the woman or AI may be recommended if the couple are
unable to have normal sexual intercourse or the man is having difficulty ejaculating
efficiently or the sperm is donated by another man.

Intrauterine insemination involves the caregiver placing the man's semen directly
inside the woman's uterus. It takes about 5 minutes and does not require
anaesthetic. Some women feel mild discomfort or intermittent cramping during the
procedure. The semen is inserted high in the woman's uterus near her fallopian
tubes where fertilisation normally occurs, bypassing her cervical mucus and the
acidic environment of her vagina, to help increase sperm survival and the chances of
conception.

3. Medications
The woman may be given medications to regulate her hormones and
menstrual cycle and/or help stimulate her egg production (induce ovulation). The
types of medications prescribed are many and varied and depend on the
particular fertility problem that is trying to be corrected. Medications are often
given in combinations with other fertility treatments the woman is undergoing.
The most common medications prescribed are Clomiphene citrate tablets, known
as Clomid or Seraphine or daily FSH injections called Puregon or Gonal F.

4. Assisted reproductive technology -ART


Assisted Reproductive Technology refers to the application of laboratory or
clinical technology to sperm, eggs and / or embryos (fertilised eggs) to assist the
conception of a baby. About 10 to 20% of couples with diagnosed infertility are
offered ART. These advanced and complex treatments have had improving
success rates in recent years but the chances of a successful pregnancy and
giving birth to a baby are still relatively low.
The success of ART depends on many factors such as the diagnosed fertility
problem, the type of technology used, the fertility clinic or specialist themselves, if
the embryos (fertilised eggs) are fresh or frozen (have been stored) and the age
of the woman.
 Egg and sperm collection
Accepting ART treatments means the woman's eggs and the man's sperm
need to be artificially collected. For the man this may just mean providing semen
in a jar provided by the clinic up to an hour or two prior to it being required for
use, or it could mean sperm retrieval through surgery. For the woman it means
taking medications to stimulate follicle or egg development and ovulation and
then having her eggs surgically removed from her ovaries, called egg collection

5. GIFT and ZIFT

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
GIFT stands for Gamete Intra-Fallopian Transfer and involves the woman
taking medications to stimulate ovulation and then having her mature eggs
collected. The eggs are then placed inside the woman's fallopian tubes, along
with a quantity of the man's sperm for fertilisation.
ZIFT or Zygote Intra-Fallopian Transfer is where the egg is fertilised by the
man's sperm in the laboratory, resulting in a zygote (or fertilised egg) and then
placed into the woman's fallopian tube.

6. IVF
In Vitro Fertilisation or IVF is similar to ZIFT except the retrieved eggs and
sperm are placed together for fertilisation in the laboratory and allowed to
develop for up to 5 days, until they become embryos. One or two embryos are
then selected and placed inside the woman's uterus, called an embryo transfer or
ET. The remaining developing embryos are frozen for use at a later date if the
fresh embryo transfer is unsuccessful, or for additional IVF pregnancy attempts.
A single or double embryo transfer is a simple procedure (similar to a pap test)
where the developing embryo(s) is placed directly inside the woman's uterus,
taking about 5 minutes and not requiring anaesthetic.

 Assisted reproduction and law


1. Artificial insemination- AI

AI is the introduction of semen into the vagina or cervix of a female by any


method other than sexual intercourse.
There are different types of artificial insemination.

1. A.I.H. Artificial insemination with semen obtained from the husband.


2. A.I.D. - Artificial insemination with semen obtained from a donor.

An AIH child raises no question of surrogate parenthood being a product of its


own parent's seeds. It can be regarded as legitimate, and process of
impregnation both justifiable and unobjectionable.
In the case of AID, fertilization takes place inside the woman's body with two
possible variations. An AID child is, thus, genetically linked to a parent outside its
own family.

 AI and challenges to legal system

In India there is no legislation regarding artificial insemination. But the doctor


has to follow general principal of law. A child born as a result of artificial
insemination is considered as legitimate, provided the child was born during
lawful wedlock.

Conception of the wife by AI does not amount to consummation of marriage; if

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
there was no successful sexual act due to the impotence of the husband. The
marriage can be declared null and void and in that case the child will illegitimate.
AID" does not amount to adultery, even if it was done without the consent of the
husband. For adultery to be committed both the parties should be physically
present and engage in sexual act and sexual union should take place. AI is not
equivalent to sexual intercourse (AIR 373-1984) AI does not contravene ethical
principles of medical practice. The doctor while doing an insemination has to
observe the following.

1. Doctor should obtain signed request from the wife and husband and wife
2. Should obtain a written informed consent from both the husband and wife.
3. Should keep detailed clinical records
4. The details of the donor should be kept as a secret in the case of A.I.D.
5. A female attainder nurse should be present at the time of insemination;
6. It is better to obtain the consent of the donor and his wife.
7. Should observe reasonable skill and care and prevent complications.

An AID child is practically divorced from the spiritual, mental emotional, and
physical lives of the adoptive parents thus, besides the question of morality and
human values involved in it.

Lamaritata v. Lucas (823 So.2d 316 (2002)) The donor and the recipient entered
into a contract whereby the donor provided sperm to the recipient with the
expectation that she would become pregnant through artificial insemination. The
agreement provided that if childbirth resulted, the donor would have no parental
rights and obligations associated with the child. The donor, in an attempt gain
parental rights of the twin boys who were born to Ms. Lamaritata argued that he was
not a sperm donor but instead the biological father, and thus should be afforded
parental rights. Issue is does a sperm donor have any legal parental rights. Court
held that In an attempt to avoid the enforcement of the contract, Mr. Lucas argued
that he was not a sperm donor. Instead, he argued that he was part of a
commissioning couple with the mother. A commissioning couple is defined as the
intended mother and father of a child who will be conceived by means of assisted
reproductive technology using the eggs or sperm of at least one of the intended
parents. There were no facts to establish this, and the intent of the parties was
established by contract. A person who provides sperm for a woman to conceive a
child by artificial insemination is not a parent. Thus, the sperm donor here has no
legal parental rights.

2. In vitro fertilization (IVF) and embryo transfer (ET)

Commonly known as 'Test Tube Baby' IVF involves fertilization of an ovum


outside the body and consequently transfer of embryo into the uterus of the
woman. Many factors affect success rates, including patient age, sperm and egg
quality, reproductive health, duration of the infertility, and medical expertise. Because

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
multiple embryos are often transferred, the risk of multiple births is the major
complication in IVF.

Case laws:

In Doombos v. Doombos (139, N.E.,2d 844 (1956) on a wife's petition for divorce
and custody of the child born to her consequent to AID, consented to by the
husband, one of the questions before the court was: whether such a child is
legitimate and belongs to the mother only? The Court held that a child so conceived
was not a child born in wedlock and therefore illegitimate. As such it was the child of
the mother alone and the husband had no rights or interest in the child, not even that
of visitation.

Conclusion And Suggestion

With the increased use of advanced technology in assisted pregnancies, more and
more families will be able to realize their dream of parenthood. Families must
consider the legal consequences of the medical choices they are making. They
should plan for the legal process by which the infant born to them will be legally
acknowledged as their child. The birth of this long-awaited child should not be
clouded by anxiety or legal uncertainty.
In conclusion, it can be stated that in formulating an Indian law on Artificial
Insemination and In Vitro Fertilization the following fundamental issues will need to
be necessarily tackled by policy makers:

§ The ethical and moral consequences of AI and IVF.


§ The primacy to be accorded to the biological need to bear a child.
§ The repercussions of AI and IVF on the stability of family life.
§ The socio-economic advantages, of adoption vis a vis AI
§ The effect of AI and IVF on population control policy of the country.

Pending legislation doctors who perform AID on childless couples should observe
the following precautions:

o Before performing the operation, the doctor should insist upon the knowledge and
full consent of both the adoptive parents.

o To avoid the chances of any inconsistent claim the identity of the donor of the seed
to the recipient-couple and vice versa should not be disclosed nor the donor should
know the result of AID.

o To avoid the possibility of transmission of any genetic defect on to a child, the


donor and the surrogate parent should be, free from all physical and mental defects.

o To avoid any kind of legal dispute, the consent in writing of the spouse of the donor
or surrogate parent, for donation of seed or surrogacy as the case may be, should

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
also be obtained by the doctor.

o To avoid the chances of prosecution of the doctor for any sexual or other offences,
the presence of a nurse or a medical assistant should be compulsory when AI is
performed embryo is transferred or seed is procured by the donor.

However, as already stated to have a proper sanction for all such propositions and to
deal effectively with many other aspects of the medical practice of artificial
insemination and in vitro fertilization, an independent and comprehensive legislation
on the subject is required.

 Surrogacy in India
Surrogacy is a method of assisted reproduction whereby a woman agrees to
become pregnant for the purpose of gestating and giving birth to a child for others to
raise.
Commercial surrogacy, or “womb for rent “, is a growing business in India. In our
rapidly globalizing world, the growth of reproduction tourism is a fairly recent
phenomenon. Surrogacy business is exploding poor women in country like India
already having alarmingly high maternal death rates.
Two types of surrogacy:
1. Altruistic surrogacy: the surrogacy in which no charges, expenses, fees,
remuneration or monetary incentive of whatever nature, except the medical
expenses incurred on surrogate mother and the insurance coverage for the
surrogate mother, are given to the surrogate mother or her dependents or her
representative.
2. Commercial surrogacy: commercialization of surrogacy services or procedures
or its component services or component procedures including selling or buying of
human embryo or trading in the sale or purchase of human embryo or gametes or
selling or buying or trading the services of surrogate motherhood by way of giving
payment, reward, benefit, fees, remuneration or monetary incentive in cash or
kind, to the surrogate mother or her dependents or her representative, except the
medical expenses incurred on the surrogate mother and the insurance coverage
for the surrogate mother.

 Surrogacy: international scenario

Laws differ widely from one country to another. In England, commercial


surrogacy arrangements are not legal and are prohibited by the surrogacy
arrangement act 1985. A surrogate mother still maintains the legal rights of the
child, even if they are genetically unrelated.

In USA, the surrogacy and its attendant’s legal issues fall under state jurisdiction
and it differs from state to state. Some states facilitate surrogacy and surrogacy

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
contracts, while others simply refuse to enforce them and some penalize
commercial surrogacy.

In Canada, the assisted human reproduction act permits only altruistic surrogacy;
surrogate mothers may be reimbursed for approved expenses, but payment of any
other considerations or fee is illegal.

In Australia, all states (except Tasmania where all kinds of surrogacy are banned.)
altruistic surrogacy has been recognized as legal. However, in all states arranging
commercial surrogacy is a criminal offence.

In japan, the science council of japan proposed a ban on surrogacy and doctors,
agents and clients will be punished for commercial surrogacy arrangements.

In Saudi Arabia, religious authorities do not allow the use of surrogate mothers.

 Heath risks associated with surrogacy

1. In the US, surrogates are given not more than 2 embryos for their safety, where as in
india, surrogates are implanted with up to 5 embryos in order to increase the
chances of pregnancy. Using such a large no. of embryos increases heath risks for
babies and the mother. This can lead to sever health issues such as hemorrhoids,
gestational diabetes, etc. multiple pregnancy increases the likelihood of requiring an
operational delivery.

2. When hormones or drugs the surrogate is instructed to take, all drugs have side-
effects.

3. Issues such as premature delivery, genetic malformation and infections which lead to
increased hospitalization of newborn are important issues to be considered in
surrogacy contract.

4. Many surrogate mothers breastfeed the newborns during the first few hours following
birth. However, parents find it difficultly in initiating the breast feeding and in
establishing the bonding the mother and child in case of surrogacy.

 Social and psychological context of surrogacy

1. Commercialization of surrogacy creates several social conflicts.


2. Given the extreme vulnerability, one-third of Indian women due to poverty,
exclusion from marginalization in labor and job markets, low educational levels,
the financial gain through surrogacy became a key push factor.
3. Since most surrogate mothers are not from well- off sections and the motive
primarily is monetary so they are easily exploited by the agents working for
commissioning parents.

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
4. Secrecy and anonymity create a negative environment that effects human
relations within and outside families.
5. Surrogacy carry social stigma in the society as it is equated with prostitution and
by virtue of that it is argued that it should be disallowed on moral grounds.
6. Surrogate mothers are kept in isolation from families, which are against human
rights.

Hence there are no. of ethical, social, legal and psychological issues
associated with surrogacy, which require urgent need for framing and
implementation of law.

 Surrogacy and women’s right to health

1. In india, currently, no law exists to protect the surrogate mother in case of birth
complications, forced abortions etc.
2. Since 2002, commercial surrogacy has almost become legal in india, and india
has become a sort of leader in it. This is the reason that allege that surrogacy
business is exploiting poor women in country like india having already high
maternal mortality ratio.
3. Surrogacy bill 2019- this bill ensure regulation of surrogacy in india, prohibiting
commercial surrogacy. This bill allows altruistic surrogacy to Indian married
couple who can’t bear children. Foreigners, NRI and persons of Indian crisis are
banned from seeking surrogate mothers in the country.
According to Kimbrell (1988) most women who get involved as surrogates do so
because they are in need of money. The surrogate mothers are often unaware of
their legal rights and due to their financial situation, they cannot afford the services of
lawyers.
Foster states that many surrogate mothers face emotional problems after having to
relinquish the child. Some women experience emotional problems in handing over
the baby.
Case laws
Baby Manji Yamada vs Union of India (AIR 2009 SC Page 84)
Baby Manji Yamada was a child born to an Indian surrogate mother for a Japanese
couple who before a month of the child’s birth separated and the future of the child
was left in dark. The biological father, Ikufumi Yamada wanted to take the child to
Japan but the legal framework had no such provision for such a case nor did the
Japanese government permit him to bring the child back home. In the end, the
Supreme Court of India had to intervene and the child was allowed to leave the
country with her grandmother. The biggest impact of the Baby Manji Yamada
decision has been that it spurred the government of India to enact a law regulating
surrogacy.
The Supreme Court of India in 2008 held surrogacy permissible in India after Manji’s
case which increased the international confidence in going in for surrogacy in India.

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
Jan Balaz Vs Anand Municipality
Gujarat High Court ruled that the birth certificate of the child born through surrogacy
will carry the name of the surrogated mother as against the biological mother and the
child would be granted a passport of India which certifies him as the Indian Citizen
and the surrogate mother in turn had to give the child to German couple in adoption,
who had sought the services of Indian surrogate mother.

The Supreme Court is still seized of an appeal against this decision and during its
hearing Supreme Court felt a grave need on the subject which made way for the
proposal of the bill of Parliament.
Conclusion
In india, surrogacy is purely a contractual understanding between the parties so
care has to be taken while drafting agreement so that it does not violate any of the
laws like child’s custody, compensation clause etc.
The government must seriously consider enacting a law to regulate surrogacy in
india in order to protect and guide couples seeking such options. Without a foolproof
legal framework implementation couples will invariably be misled and the surrogates
exploited.

 Electro Conclusive therapy (ECT)


Electroconvulsive therapy (ECT) is a procedure used to treat certain psychiatric
conditions. It involves passing a carefully controlled electric current through the
brain, which affects the brain’s activity and aims to relieve severe depressive and
psychotic symptoms.
Modern day ECT is safe and effective. It can relieve symptoms of the most severe
forms of depression more effectively than medication or therapy, but ECT should be
used only when absolutely necessary.
Before the ECT procedure, the person is given a general anesthetic and a muscle
relaxant. Electrodes are placed on one (unilateral) or both (bilateral) sides of the
scalp and a small electric current is passed between these until a brief generalized
seizure occurs. The person does not feel anything due to the anesthetic, and does
not convulse due to the muscle relaxant.
Side-effects
 loss of memory about the events immediately before and after ECT,
 heart rhythm disturbances
 low blood pressure
 headaches
 nausea
 sore muscles, aching jaw, confusion

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
 Medical decision making relating to PVS patient

Withdrawal of nutrition and hydration, is a difficult and sensitive issue for all those
working with people in the vegetative state. There are arguments against the
decision to withdraw any treatment that might result in the patient deteriorating or
dying. These arguments include the view that all life is worth having, that we can
never be certain that the patient is not aware, and concerns that there may be new
scientific developments in the future from which the patient would benefit. Others
argue that the patient has no interests in life; that it is undignified, if not an assault, to
insert tubes into a permanently unconscious person; that very few people would
want to survive in this condition; and that it prevents loves ones from grieving. These
strongly held opposing views can make clinical decision making very difficult for the
clinician. Once the decision has been made to withdraw treatment then the clinician
has to be certain that the patient is in the vegetative state, that there are no factors
preventing the patient demonstrating awareness, that he has received expert
assessment and treatment, and that the prognosis for lack of recovery is as clear as
it can be. It is important to support family and staff throughout this process. The
concept of withdrawal of nutrition and hydration is a sensitive issue and clinicians
can expect to be considered as not acting in the patient's best interest whatever
decision is taken.

 Organ transplant
Laws and rules governing organ transplantation in India
The primary legislation related to organ donation and transplantation in India is
the Transplantation of Human Organs Act, 1994, and it is aimed at regulation of
removal, storage and transplantation of human organs for therapeutic purposes and
for prevention of commercial dealings in human organs.
The main provisions of the act (including the amendments and rules of 2014) are as
follows:
A. Brain death identified as a form of death.
The brain death certification is done by a panel of four doctors:
(I) hospital administrator;
(II) resident doctor of the hospital;
(III) neurologist/neurosurgeon/physician, intensivist, and anaesthetist;
(IV) treating doctor.
In the recent 2014 rules apart from neurologist or neurosurgeons,
anaesthetists, critical care specialists, intensivists, physicians, or surgeons have
been included to facilitate brain death declaration.

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
B. Allows transplantation of human organs and tissues from living donors and
cadavers (after cardiac or brain death).
C. Regulatory and advisory bodies for monitoring transplantation activity and
their constitution defined.

i) Appropriate authority (AA): inspects and grants registration to hospitals for


transplantation enforces required standards for hospital, conducts regular
inspections to examine the quality of transplantations.
ii) Advisory committee: consisting of experts in the domain who shall advise
the appropriate authority.
iii) Authorization committee (AC): regulates living donor transplantation by
reviewing each case to ensure that the living donor is not exploited for
monetary considerations and to prevent commercial dealings in
transplantation.
iv) Medical board (brain death committee): panel of doctors responsible for
brain death certification.

D. Living donors are classified as either a near relative or a non-related


donor

i). a near relative (spouse, children, grandchildren, siblings, parents and


grandparents) needs permission of the doctor in charge of the transplant center
to donate his organs.
ii) a non-related donor needs permission of an Authorization Committee
established by the state to donate his organs.
E. Swap transplantation: when a near relative living donor is medically
incompatible with the recipient, the pair is permitted to do a swap transplant with
another related unmatched donor/recipient pair.
F. Authorization of organ donation after brain death
i) May be given before death by the person himself/herself or
ii) By the person in legal possession of the body. A doctor shall ask the patient
or relative of every person admitted to the ICU whether any prior authorization
has been made. If not, the patient or his near relative should be made aware
of the option to authorize such donation.
iii) Authorization process for organ or tissue donation from unclaimed bodies
outlined.

G. Any hospital having intensive care unit (ICU) facilities along with manpower,
infrastructure and equipment as required as required to diagnose and maintain the
brain stem dead person and to retrive and transport organs and tissues including the
facility for their temporary storage, can register as a retrieval center.

H. Cost of donor management, retrieval, transplantation and preservation to be borne


by the recipient, institution, government, NGO or society and not by the donor family.

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
I. Qualifications of transplant surgeons, cornea and tissue retrieval technicians defined.

J. The central government shall maintain a registry of the donors and recipients of
human organs and tissues.

K. Penalties for removal of organ without authority, making or receiving payment for
supplying human organs or contravening any other provisions of the act have been
made very stringent in order to serve as a deterrent for such activities.

Foreign donors
In case of foreign donors donating to their relatives in India, the transplantation is
permitted only in near-related donors. Indian living donors wanting to donate to a
foreigner other than near relative shall not be considered. In case of foreigners
coming for transplantation in India, for example, donor and recipient being
foreigners, the transplant is permitted in India with permission from a senior embassy
official of the country of origin who certifies the relationship between the donor and
the recipient, and in case, a country does not have an embassy in India, and the
certificate of relationship is issued by the government of that country.
Among all recipients listed for transplants from deceased donors, priority will be
given in following order:
(i) those who do not have any suitable living donor among near relatives;
(ii) those who have a suitable living donor available among near relatives, but
the donor has refused in writing to donate; and
(iii) those who have a suitable living donor available and who has also not refused
to donate in writing. The sequence of allocation of organs shall be in the
following order:
(i) State list,
(ii) Regional list,
(iii) National list,
(iv) Person of Indian origin,
(v) Foreigner.

Conclusion

The transplantation act has evolved over last few decades to its present form.
The latest rules are available on the website of Indian Society of Organ
Transplantation as well. As transplant physicians and surgeons, we should make
ourselves aware of the existent rules. Even the students in transplant program
should be made aware of these guidelines. This will go a long way in avoiding legal
hassles in day-to-day transplant practice.

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
 Telemedicine
Telemedicine can be defined as the use of technology (computers, video,
phone, messaging) by a medical professional to diagnose and treat patients in a
remote location. Telemedicine allows health care professionals to evaluate, diagnose
and treat patients at a distance using telecommunications technology.
In the early days, telemedicine was used mostly to connect doctors working with
a patient in one location to specialists somewhere else. This was of great benefit to
rural or hard to reach populations where specialists aren’t readily available.
Throughout the next several decades, the equipment necessary to conduct remote
visits remained expensive and complex, so the use of the approach, while growing,
was limited.
The rise of the internet age brought with it profound changes for the practice of
telemedicine. The proliferation of smart devices, capable of high-quality video
transmission, opened up the possibility of delivering remote healthcare to patients in
their homes, workplaces or assisted living facilities as an alternative to in-person
visits for both primary and specialty care.
 Telehealth and telemedicine
Telehealth is different from telemedicine because it refers to a broader scope of
remote healthcare services than telemedicine. While telemedicine refers specifically
to remote clinical services, telehealth can refer to remote non-clinical services, such
as provider training, administrative meetings, and continuing medical education, in
addition to clinical services.
 Telemedicine benefits

Patients enjoy:
 Less time away from work
 No travel expenses or time
 Less interference with child or elder care responsibilities
 Privacy
 No exposure to other potentially contagious patients

Providers enjoy:
 Increased revenue
 Improved office efficiency
 An answer to the competitive threat of retail health clinics and on-line only
providers
 Better patient follow through and improved health outcomes
 Fewer missed appointments and cancellations
 Private payer reimbursement

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
HIV/AIDS and the Indian legal scenario
This is a social right to health which has been very well articulated to
persons suffering with HIV/AIDS, due to the large levels of discrimination faced by
them. The denial of services vis-à-vis care and support represents one of the most
immediate and pressing concerns of people living with HIV/AIDS. The courts have
protected people with HIV/AIDS against discrimination in employment and services,
but the issue of the right to health of persons with HIV is a new and emerging area of
adjudication. A recent Full Bench decision of the Andhra Pradesh High Court views
AIDS as a public health issue and one that needs to be articulated in terms of the
constitutional guarantee to the right to life, making employers and health providers
accountable for any negligence, omission or failure to conform to procedure
One of the first litigations on the issue of HIV/AIDS in India is Lucy D’ Souza vs.
State of Goa in which S. 53(1) (vii) of the Goa Public Health Act, 1987, empowered
the government to isolate a person suffering with AIDS, was challenged.
Another case which brought the issue of privacy before the courts is Mr. X
vs. Hospital Z This petition dealt with two issues; firstly, right to privacy of a patient,
specially an HIV/AIDS patient and secondly, the right of an individual to be
safeguarded from any threat to her health. The Petitioner was tested positive for HIV
by the Respondent hospital, which acted upon the discovery and informed
Petitioner’s fiancée about this condition because of which the marriage was called off
and his community ostracized him. Thus, this petition was filed claiming that there
was a breach of privacy and confidentiality by the hospital and the doctor. The
Supreme Court observed that the relationship between doctor and patient was that
of trust. No information acquired during course of treatment should be divulged
without the prior permission of the patient .
The statutory provisions impose a duty upon the person not to marry as
marriage would have the effect of spreading the infection, which obviously is
dangerous to life of the woman whom he marries. Therefore the hospital’s act was to
protect the life of another person therefore, they could not be held liable for
consequences of their act.
Law and policy are the bulwarks of human rights. The provisions in the
Constitution of India protect the rights of HIV/AIDS affected people. Article 14
guarantees the right of equality of treatment to HIV/AIDS patients. Articles 15 and 16
prohibit discrimination in public facilities and public employment respectively. Article
21 protects the right to life, personal liberty and ensures the right to privacy. Chapter
IV enshrining The Directive Principles of State Policy directs States to ensure that all
citizens including HIV/AIDS patients have an adequate mean of livelihood, to make
provisions for securing just and humane conditions of work, to improve public health
vide Article 39, 42 and 47 respectively.9 However, these general provisions of the
constitution were insufficient in dealing with the specific problems of the HIV/AIDS

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary
community. In an attempt to address the looming and unresolved social, economic
and legal struggles faced by HIV affected people in India, the first HIV/AIDS Bill was
drafted in 1989. However, it was subsequently withdrawn as it had several
discriminatory provisions such as mandatory testing and confinement of infected
persons.10 The need for a new HIV/AIDS Bill was recognised at the International
Policy Makers Conference on HIV/AIDS, held in New Delhi in May2002.

Notes on Health Law prepared by Manna Simon Abraham, 3rd semester [Link] LL. B
CSI College for Legal Studies, Kannakary

Common questions

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Commercial surrogacy in India has been criticized for exploiting poor women and compromising their health rights. The lack of legal protection for surrogate mothers has been a significant issue, leading to exploitation due to their socio-economic vulnerabilities. Using multiple embryos in procedures, high maternal mortality rates, and insufficient post-birth care contribute to the health risks. Moreover, the Surrogacy Bill 2019 seeks to regulate this by banning commercial surrogacy and allowing only altruistic surrogacy for Indian couples. However, women often lack awareness about their legal rights, making them susceptible to further exploitation .

Indian case law includes several precedents that demonstrate accountability for health providers. In cases like Paschim Banga Khet Mazdoor Samity v. State of West Bengal, failure to provide timely medical treatment was deemed a violation of the right to life . Moreover, the Supreme Court in the case of Lucy D’ Souza vs. State of Goa highlighted issues related to health provider accountability by challenging Section 53(1) (vii) of the Goa Public Health Act, 1987, where the isolation of an AIDS patient without justification was questioned .

In India, the right to life under Article 21 has been interpreted to encompass maternal health, referring to the Constitution's aim to improve public health and ensure safe pregnancy and childbirth. While not explicitly stated, the repeated acknowledgment in case law, such as in Ramakant Rai vs. Union of India, and discussions around maternity benefits reinforce this inclusion. Furthermore, the substantial maternal mortality rates emphasize the importance of addressing maternal health as part of the fundamental right to life .

Judicial activism in India has significantly influenced the recognition of health rights as fundamental rights by interpreting Article 21 to include conditions necessary for a dignified life. Landmark cases like Paschim Banga Khet Mazdoor Samity v. State of West Bengal and Consumer Education and Research Centre vs. Union of India have used PILs to address the state's failures in providing health services, subsequently evolving a broader constitutional interpretation. The judiciary's proactive role has turned public health mandates from non-justiciable directives into enforceable rights, compelling legislative and policy changes .

The Lucy D’ Souza vs. State of Goa case challenged the provisions under the Goa Public Health Act, 1987, that allowed for the isolation of individuals with AIDS without providing a broader public health justification. This case underscored the tension between individual rights and public health measures. It prompted a re-evaluation of policies regarding the treatment of contagious diseases, emphasizing the need for policies that respect individual liberties while still protecting public health. The case highlighted the necessity for legal frameworks that balance individual rights with effective disease control measures .

The decision in Consumer Education and Research Centre vs. Union of India was pivotal for worker health rights. The Supreme Court held that the right to medical care is a fundamental right under Article 21, necessary for ensuring a meaningful and dignified life. This case affirmed that employers are responsible for ensuring the health and safety of workers, highlighting that their right to health is integral to their right to life. Consequently, it reinforced the notion that inadequate workplace health measures violate constitutional rights and can be challenged legally .

Indian legislative frameworks face challenges in surrogacy due to the exploitation of financially vulnerable women, health risks, and lack of clear legal rights for surrogate mothers. Before the 2019 Surrogacy Bill, commercial surrogacy was almost legal, leading to ethical and legal dilemmas. The 2019 Bill addressed these issues by prohibiting commercial surrogacy, permitting only altruistic surrogacy for Indian couples, and banning foreigners from seeking surrogacy in India. Although it aims to protect surrogate mothers, the Bill also limits availability for commissioning parents, raising questions about its implementation and effectiveness .

The Supreme Court's decision in Mr. X vs. Hospital Z highlighted the complex balance between patient privacy and public health safety. The Court emphasized the trust inherent in the doctor-patient relationship, ruling that information acquired during treatment should not be disclosed without the patient's consent. However, the Court also recognized the necessity of protecting others from health risks, such as the potential transmission of HIV, justifying the disclosure made by the hospital to protect the health of the fiancée . This case set a precedent by balancing privacy with the broader right to safety, thus impacting future considerations of privacy in healthcare contexts.

Article 47 of the Indian Constitution mandates the state to prioritize the raising of the nutrition level and standard of living of its people while improving public health. It explicitly states that the state should also work towards prohibiting the consumption of intoxicating drinks and drugs, except for medical purposes, as they are injurious to health. Hence, Article 47 underscores the state's duty to enhance public health and wellbeing as a primary obligation .

The Indian judiciary expanded the interpretation of Article 21 to include the right to health by considering the right to life as not just a mere existence but a life with dignity. Initially, right to health was part of the Directive Principles of State Policy and was not directly enforceable. Over time, through various Public Interest Litigations (PILs), the judiciary began interpreting Article 21 to include rights essential to life such as education, livelihood, and health. This inclusion was reinforced by reading Article 21 with Articles 14, 46, and 47, which emphasize justice, equality, and the improvement of public health .

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