Overview of Health Law in India
Overview of Health Law in India
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.
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.
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.
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
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.
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.
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.
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.
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
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.
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 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.
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.
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.
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 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.
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.
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.
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
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.
Homeopathy
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
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.
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
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
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.
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
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.
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.
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).
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.
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.
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 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.
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.
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.
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).
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.
Elderly
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.
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
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.
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
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:
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.
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.
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.
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.
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:
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:
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.
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.
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.
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.
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.
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.
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:
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 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.
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.
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.
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.
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.
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.
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.
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
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 .