HEALTH LAW :NOTES

The Article is written by Manna Simon Abraham student of CSI College For Legal Studies Kannakkary, Kottayam, Mahatma Gandhi University, Kottayam

Health law

Contents:


➢ Module 1

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


➢ Module 2

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


➢ Module 3

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


➢ Module 4

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


➢ Module 5

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

Module 1

What is Health law?

WHO defines health as “a state of complete physical, mental and social well-being and not merely the absence of disease or informality.”

Health law is a field of law that encompasses federal, state and local laws, rules, regulations and other jurisprudence among providers, payers and vendors to the health care industry and its patients, and delivery of care services, with an emphasis on operations, regulatory and transactional issues.

Interface between law and health

Medicine and law were related from early times. This relation resulted as a necessity of protecting communities from the irresponsible acts of impostors.

The law indirectly influences medical practice by structuring the delivery and financing of medical services, and it does so directly in three major ways:

- license requirements,

-restrictions on practice, and

- redress for wronged patients.

The law generally supports customary medical practice and provides the medical profession with a great deal of autonomy. A dramatic example is the determination of death and the issuance of a death certificate.


Role of state in ensuring health:

The State priority is reflected through its policies and programmes undertaken by governments. Government has identified six priority programme areas, namely urban low cost sanitation, urban waste water management, urban solid waste management including hospital waste management, rural environmental sanitation, industrial waste management and air pollution control, and strengthening of health surveillance and support services.

Health is a State subject in India. However, many states do not have a clear Health Policy. The strategies of the states are mostly guided by the National Health Policy and the National Programs.

● The Government is responsible to provide health services to the public. In India the health services are provided both by the Central and State Governments. But the available resources with governments are not enough to cover all citizens under health care services. Hence, services provided by private practioner, hospitals and nursing homes are predominant.


● Right to health and emergency medical care is an aspect of right to life under Article 21 of the Constitution, it has been acknowledged as a fundamental right of the people. This has been echoed in the International Conventions on Human Rights.

● Government initiatives in the public health sector have recorded some noteworthy successes over time. Smallpox and Guinea Worm Disease have been eradicated from the country; Polio is on the verge of being eradicated; Leprosy, Kala Azar, and Filariasis can be expected to be eliminated in the foreseeable future. The period after the announcement of NHP-83 has also seen an increase in mortality through ‘life-style’ diseases diabetes, cancer and cardiovascular diseases.

● Another area of grave concern in the public health domain is the persistent incidence of macro and micro nutrient deficiencies, especially among women and children. In the vulnerable subcategory of women and the girl child, this has the multiplier effect through the birth of low birth weight babies and serious ramifications of the consequential mental and physical retarded growth.


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

• Implementation of public health programmes through local self governments.

• Set up of organized urban primary health care infrastructure.

• Co-operation of private health practitioners in national disease control programmes.

• Integrated disease control network from the lowest rung of public health administration to the highest level under the Central Government by 2005.

• Identification of specific programmes targeted at women's health and

• Baseline estimates for the incidence of TB, Malaria and Blindness by 2005.


Six other proposals deal with the aspects of regulation in the health care system:

● Setting up of a Medical Grants Commission.

● Raising postgraduate seats in 'public health' and 'family medicine' to 25 per cent.

● Legislation for minimum infrastructure standard by 2003.

● Legislation for minimum quality standard by 2003.

● Strengthening of food and drug administration


Recognition of health as human right

The right to health is a fundamental part of our human rights and of our understanding of a life in dignity. Internationally, it was first articulated in the 1946 Constitution of the World Health Organization (WHO), whose preamble defines health as “a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity”. The preamble further states that “the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition.”

The 1948 Universal Declaration of Human Rights also mentioned health as part of the right to an adequate standard of living (art. 25). The right to health was again recognized as a human right in the 1966 International Covenant on Economic, Social and Cultural Rights.

Key aspects of right to health

The right to health is an inclusive right: We frequently associate the right to health with access to health care and the building of hospitals. This is correct, but the right to health extends further. It includes a wide range of factors that can help us lead a healthy life;

➢ Safe drinking water and adequate sanitation;

➢ Safe food;

➢ Adequate nutrition and housing;

➢ Healthy working and environmental conditions;

➢ Health-related education and information;

➢ Gender equality.

The right to health contains freedoms: These freedoms include the right to be free from non-consensual medical treatment, such as medical experiments and research or forced sterilization, and to be free from torture and other cruel, inhuman or degrading treatment or punishment.

The right to health contains entitlements:

➢ The right to a system of health protection providing equality of opportunity for everyone to enjoy the highest attainable level of health;

➢ The right to prevention, treatment and control of diseases;

➢ Access to essential medicines;

➢ Maternal, child and reproductive health;

➢ Equal and timely access to basic health services;

➢ The provision of health-related education and information;


Health services, goods and facilities must be provided to all without any discrimination.

All services, goods and facilities must be available, accessible, acceptable and of good quality.


The link between the right to health and other human rights


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


International perspectives


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


Conventions

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


1. The States, Parties to the present Covenant recognize the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.

2. The steps to be taken:

(a) The provision for the reduction of the stillbirth rate and of infant mortality and for the healthy development of the child;

(b) The improvement of all aspects of environmental and industrial hygiene;

(c) The prevention, treatment and control of epidemic, endemic, occupational and other diseases;

(d) The creation of conditions which would assure to all medical service and medical attention in the event of sickness.

International human rights treaties recognizing the right to health


• The 1965 International Convention on the Elimination of All Forms of Racial Discrimination: art. 5 (e) (iv)

• The 1966 International Covenant on Economic, Social and Cultural Rights

• The 1979 Convention on the Elimination of All Forms of Discrimination against Women

• The 1989 Convention on the Rights of the Child: art. 24

● 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 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 at any rate reduce absenteeism on grounds of sickness, etc. Health is thus a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity


● Very significantly, while adjudicating on the social right to health, the Supreme Court has specifically considered the issue of availability of resources. This was discussed in the popular case of Paschim Banga Khet Mazdoor Samity & Ors vs State of West Bengal & Ano where the Court addressed the issue of adequacy and availability of emergency medical treatment. In this case, Hakim Sheikh, a member of the Paschim Banga Khet Mazdoor Samity, fell off a train and suffered serious head injuries. He was brought to a number of State hospitals, including both primary health centers and specialist clinics, for treatment of his injuries. Seven state hospitals were unable to provide emergency treatment for his injuries because of a lack of bed space and trauma and neurological services. He was finally taken to a private hospital where he received his treatment. Feeling aggrieved by the callous and insensitive attitude of the government hospitals in Calcutta in providing emergency treatment the petitioner filed this petition in the Supreme Court and sought compensation. The issue presented to the Court was whether the lack of adequate medical facilities for emergency treatment constituted a denial of the fundamental right to life under Article 21.

It was held that Article 21 of the Constitution casts an obligation on the State to take every measure to preserve life. The Court found that it is the primary duty of a welfare State to ensure that medical facilities are adequate and available to provide treatment. Due to the violation of the right to life of the petitioner, compensation was awarded to him. In this case, the Supreme Court recognized that financial resources are needed for providing these facilities.


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

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


Mental disability and right to health

Section 81 of Mental Health Act, 1987 stipulates that:

1. “No mentally ill person shall be subjected during treatment to any indignity (whether physical or mental) or cruelty

2. No mentally ill person under treatment shall be used for purposes of research, unless-

(i) such research is of direct benefit to him for purposes of diagnosis or treatment, or

(ii) such person, being a voluntary patient, has given his consent in writing or where such person (whether or not a voluntary patient) is incompetent, by reason of minority or otherwise, to give valid consent, the guardian or other person competent to give consent on his behalf, has given his consent in writing, for such research.”


In S.P. Sathe v State of Maharashtra , the Bombay High Court regulated the prescription of indiscriminate electric shocks to mentally ill persons. The directions included that reports be made whenever electric shocks were given by a prison psychiatrist. A writ petition in the High Court of Bombay at Panaji challenged the practice of administrating ECT without anaesthesia at the Institute of Psychiatry and Human Behaviour (IPHB), Panaji, Goa. Patients at the IPHB were administered ECT without anaesthesia because no anaesthetist was available and the machine was no.

The practice was barbaric, inhuman and hence in violation of Article 21 of the Constitution; in Violation of Section 81 (Chapter VIII) of the Mental Health Act, 1987, providing that no mentally ill person be subjected during treatment to indignity or cruelty. Without anaesthesia it could lead to patient discomfort, fractures of the spine and long bones, and dislocations particularly of the jaw. The ECT was also being administered without the patients’ informed consent.

HIV and the right to health

This is a social right to health which has been very well articulated to persons suffering with HIV/AIDS, due to the large levels of discrimination faced by them. The courts have protected people with HIV/AIDS against discrimination in employment and services, but the issue of the right to health of persons with HIV is a new and emerging area of adjudication. A recent Full Bench decision of the Andhra Pradesh High Court views AIDS as a public health issue and one that needs to be articulated in terms of the constitutional guarantee to the right to life, making employers and health providers accountable for any negligence, omission or failure to conform to procedure.

One of the first litigations on the issue of HIV/AIDS in India is Lucy D’ Souza vs. State of Goa in which S. 53(1) (vii) of the Goa Public Health Act, 1987, empowered the government to isolate a person suffering with AIDS, was challenged.

Another case which brought the issue of privacy before the courts is Mr. X vs. Hospital Z This petition dealt with two issues; firstly, right to privacy of a patient, specially an HIV/AIDS patient and secondly, the right of an individual to be safeguarded from any threat to her health. The Petitioner was tested positive for HIV by the Respondent hospital, which acted upon the discovery and informed Petitioner’s fiancée about this condition because of which the marriage was called off and his community ostracized him. Thus, this petition was filed claiming that there was a breach of privacy and confidentiality by the hospital and the doctor. The Supreme Court observed that the relationship between doctor and patient was that of trust. No information acquired during course of treatment should be divulged without the prior permission of the patient .

The statutory provisions impose a duty upon the person not to marry as marriage would have the effect of spreading the infection, which obviously is dangerous to life of the woman whom he marries. Therefore the hospital’s act was to protect the life of another person therefore, they could not be held liable for consequences of their act.

Women’s right to health

Right to Protection of Life and Personal Liberty (Article 21) ensures that no person shall be deprived of his / her life or personal liberty, except according to the procedure established by law. While the provision of health services is essential to ensure good health pregnancy, childbirth and the postpartum period are one of the riskiest stages of a woman’s life. Every year over 1, 30,000 Indian women lose their lives in pregnancy and childbirth. The right to life can be extended to include the health rights of mothers to go safely through pregnancy and childbirth. However, this right has not been explicitly guaranteed, though the Indian Constitution does make reference to maternity related benefits for the women.

In Ramakant Rai and Health Watch Up and Bihar vs. Union of India petitioners contended that the respondents have totally failed and neglected to implement the Ministry of Health and Welfare’s Guidelines on Standards of Female Sterilization (the Sterilization Guidelines), which were enacted in October 1999. The petition relied upon domestic law, too, arguing that the respondents have “failed to realize” the constitutional right to health, which is a part of the right to life enshrined in Articles 14, 15, 21, and 47 of the Constitution of India. In addition, the petition cited domestic case law in which the Supreme Court established the right to health, held the government vicariously liable for medical negligence, and recognized a right to compensation stemming from governmental negligence. In response to the PIL, the central government has issued a National Family Planning Insurance Scheme to award monetary compensation to women and their families in cases of complications, pregnancy or death after sterilization procedures in either government or accredited private health facilities.

In Supreme Court Legal Aid Committee vs. State of Bihar the Supreme Court held that the responsibility to provide immediate medical treatment to an injured person in a medico-legal case extends even to the police. Thus, where the deceased who was lynched by the mob for attempting to rob passengers of train, died because of negligence of the police in taking him to a hospital on time and also for the inhuman manner in which he was bound up and dumped in the vehicle, the Court held that this amounted to a violation of right to life and the State was bound to pay Rs.20, 000 as compensation for the loss of life.

In a historic judgment in Consumer Education and Research Centre vs. Union of India14 held that the right to medical care is a fundamental right under Art.21, it is essential for making the life of the workman meaningful and purposeful with the dignity of person. The right to health in all its forms and at all levels contains the following interrelated and essential elements namely;

(i) Availability of public health and health-care facilities, goods and services,

(ii) Accessibility (both physical and economically affordability) to health facilities,

(iii) Acceptability of all health facilities, goods and services

(iv) Quality of services


The legislations focused on health care:

● The Indian Medical Council Act 1956 (Amended 1964, 1993 and 2001)

● The Drugs and Cosmetic Acts 1940

● The Indian Nursing Council Act 1947

● The Dentist Act 1948

● The Pharmacy Act 1948

● The Drugs (Control) Act 1948


Approach of judiciary in right to health


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

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


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

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


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


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


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


Right to Emergency medical care

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


● The Supreme Court has repeatedly emphasised to the government and other authorities for focusing and giving priority to the health of its citizens. To secure protection of one's life has been declared to be one of the foremost obligations of the State. It is not merely a right enshrined under Article 21 but an obligation cast on the State to provide this, both under Article 21 and under Article 47.


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

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


Pt. Parmandand Katara vs. Union of India and Ors. In this case, a public-spirited person has filed a Public Interest Litigation under Article 32 of the Constitution of India, 1950. The said petition was filed in response to a news report of a scooterist who was knocked down by a car and died due to lack of medical treatment. Following the accident, the scooterist was taken to the nearest hospital but was turned away and sent to another hospital 20 km away, which was authorised to handle medico-legal cases. The Hon'ble Apex court has held that it is the Right of the Citizen and also the obligation on the State to preserve life and doctors at government hospitals are therefore required to provide medical assistance to preserve life.

In Paschim Banga Khet Mazdoor Samiti vs State of West Bengal where the victim, an agricultural labour, who fell from a train and was denied emergency medical aid in 5 public hospitals and ultimately was admitted in a private hospital where he had to pay an exorbitant amount. Supreme Court has held that preservation of human life is utmost important because if timely medical care is not provided to the victim it may cause his death or leave him permanently paralysed. Hence it is the fundamental right of the citizens to be provided with emergency medical care without any condition.


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


Conditions which call for emergency medical care are generally:

1. Accidents

2. Road accidents /Rail accidents

3. Collapses

4. Natural calamities

5. Delivery

6. Bites

7. Cardiac or coronary attacks.


Conclusion:

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


Regulation of Public health care system


The need for an efficient and effective public health system in India is large.

Indian healthcare system has been historically dominated by provisioning of medical care and neglected public health.


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

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


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


Facilities


The healthcare system is organized into primary, secondary, and tertiary levels. At the primary level are Sub Centers and Primary Health Centers (PHCs). At the secondary level there are Community Health Centers (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.


(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 Centers: - Patients can be referred from local sub centers to PHCs for more complex cases. A major difference from Sub Centers 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.


Private health care systems

The private health care sector has grown significantly over time. The growth of this sector has been further triggered by a number of factors, including a liberalized economic policy, rapid influx of medical technology, growing deficits of public sector hospitals, and a rising middle income class. Its growth has profound implications for the existing character of the Indian health care system and its future course.


Facilities and providers

The growth in the number of hospitals and hospital bed capacity in the private sector is quite visible. During last 10 years, the number of hospitals has doubled and bed capacity has grown more than 50 percent.

However, it should be noted that the number of hospitals, dispensaries and doctors operating in the private sector is in fact much larger. There are large numbers of institutions in the private sector, including the nursing homes and private clinics, which have not been recorded in these health statistics.

The structure of the health care system in India is complex and it includes various types of providers. These providers practice in different systems of medicines and facilities.

The providers and facilities in India can be broadly classified by using three dimensions:

● ownership styles (public, not-for-profit, and for-profit);

● systems of medicine (allopathic, homeopathic, and traditional)

● types of organization (hospitals, dispensaries, and clinics)


Regulations

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

a. Drugs Related

b. Practice Related

c. Facilities Related

Health care delivery system In India

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

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


● The healthcare infrastructure in India consists of primary, secondary, and tertiary health care. The healthcare at these levels is provided by both public and private health care providers.


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


● While states are responsible for the functioning of the health care delivery system, Centre also has a responsibility towards the state's health care system in 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-centers provides the basic healthcare facilities to the people and services in relation to the mother and child care (MCH), safe delivery, universal immunization programme, family welfare services, primary medical care, control of communicable and non-communicable diseases programmes.

● Primary Health Centre (PHC)

Primary Health Centre (PHC) is the first interaction point between the medical officer and village community.


● Community Health Centers (CHC’S)

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


● Secondary Health care

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

● Tertiary Health Care

At the tertiary health care, specialized preventive care is given to the patients usually on referral from primary and secondary health care centers. 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 centers in case of insufficient treatment and referred back to the primary and secondary health care centers after getting treatment at tertiary health care centers.

Allopathy

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

The term "allopathy" was coined in 1810 by Samuel Hahnemann (1755-1843) to designate the usual practice of medicine (allopathy) as opposed to homeopathy, the system of therapy that he founded. Homeopathy is based on the concept that disease can be treated with minute doses of drugs thought capable of producing the same symptoms in healthy people as the disease itself. Although allopathic medicine" was rejected by mainstream physicians, it was adopted by alternative medicine advocates to refer pejoratively to conventional medicine


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


Most modern science-based medical treatments (antibiotics, vaccines, and chemotherapeutics, for example) do not fit Samuel Hahnemann's definition of allopathy, as they seek to prevent illness, or remove the cause of an illness by acting on the cause of disease.


Homeopathy


● Homeopathy or homoeopathy is a pseudoscientific system of alternative medicine. It was created in 1796 by the German physician Samuel Hahnemann.

● Its practitioners, called homeopaths, believe that a substance that causes symptoms of a disease in healthy people would cure similar symptoms in sick people; this doctrine is called similia similibus curentur, or "like cures like".

● Homeopathic preparations are termed remedies and are made using homeopathic dilution. In this process, a chosen substance is repeatedly and thoroughly diluted. The final product is chemically indistinguishable from the diluent, which is usually either distilled water, ethanol or sugar; often, not even a single molecule of the original substance can be expected to remain in the product. Practitioners claim that such preparations, upon oral intake, can treat or cure disease.

● Hahnemann believed that large doses of drugs that caused similar symptoms would only aggravate illness, he advocated extreme dilutions of the substances;

he devised a technique for making dilutions that he believed would preserve a substance's therapeutic properties while removing its harmful effects. Hahnemann believed that this process aroused and enhanced "the spirit-like medicinal powers of the crude substances".

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

Allergies

Migraines

Depression

Chronic fatigue syndrome

Rheumatoid arthritis

Irritable bowel syndrome

Premenstrual syndrome

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

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


Unani and applied systems


● Unani system of medicine is a great healing art as well as science. It treats a person as a whole not as a group of individual parts. It is aimed at treating body, mind and soul. This system is based on Hippocratic theory of four humors viz. blood, phlegm, yellow bile and black bile.

● The World Health Organization (WHO) has recognized the Unani System of Medicine (USM) as an alternative system to cater the health care needs of human population. Unani is one of the most well-known traditional medicine systems in China, Egypt, India, Iraq, Persia and Syria.

● India has accepted it as one of the alternative health care system and has given it official status.

● Similar to Ayurvedic medicine, Unani medicine also recommends daily use of therapeutic procedures like chewing sticks for brushing of teeth in the morning as well as after every meal for the prevention and maintenance of oral health.

● However, since most of the drugs which have been described in Unani material medical and are widely used by the physicians of Unani medicine in the treatment of dental diseases have still not been studied scientifically for their claimed effects. Therefore, there is an element of doubt regarding their efficacy and safety that can only be removed by scientific validation.

● There are 7 principles on the unani doctrine. these principles include (1) arkan, or elements, (2) mizaj, or temperament,

(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

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.


Beneficence

The term beneficence refers to actions that promote the well being of others. In the medical context, this means taking actions that serve the best interests of patients and their families. However, uncertainty surrounds the precise definition of which practices do in fact help patients.

Non-maleficence

The concept of non-maleficence is embodied by the phrase, "first, do no harm," or the Latin, primum non nocere. That it is more important not to harm your patient, than to do them good, which is part of the Hippocratic oath that doctors take.

Much harm has been done to patients as a result, as in the saying, "The treatment was a success, but the patient died." It is not only more important to do no harm than to do good; it is also important to know how likely it is that your treatment will harm a patient. So a physician should go further than not prescribing medications they know to be harmful—he or she should not prescribe medications (or otherwise treat the patient) unless s/he knows that the treatment is unlikely to be harmful; or at the very least, that patient understands the risks and benefits, and that the likely benefits outweigh the likely risks.

Double effect

Double effect refers to two types of consequences that may be produced by a single action, and in medical ethics it is usually regarded as the combined effect of beneficence and non-maleficence.

A commonly cited example of this phenomenon is the use of morphine or other analgesic in the dying patient. Such use of morphine can have the beneficial effect of easing the pain and suffering of the patient while simultaneously having the maleficent effect of shortening the life of the patient through the deactivation of the respiratory system.


Justice

Justice in health care is usually defined as a form of fairness, or as Aristotle once said, "giving to each that which is his due." This implies the fair distribution of goods in society and requires that we look at the role of entitlement. The question of distributive justice also seems to hinge on the fact that some goods and services are in short supply, there is not enough to go around, thus some fair means of allocating scarce resources must be determined.

It is generally held that persons who are equals should qualify for equal treatment. This is borne out in the application of Medicare, which is available to all persons over the age of 65 years. This category of persons is equal with respect to this one factor, their age, but the criteria chosen says nothing about need or other noteworthy factors about the persons in this category. In fact, our society uses a variety of factors as criteria for distributive justice, including the following:

1. To each person an equal share

2. To each person according to need

3. To each person according to effort

4. To each person according to contribution

5. To each person according to merit

6. To each person according to free-market exchanges


Patient’s rights

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


1. Right to information


● Physicians or their qualified assistants are required to provide adequate information about your illness, its diagnosis (provisional or confirmed, as it may be), proposed investigation and possible complications to the patient. If the patient is not in a state to understand this, the physician or their assistant is required to provide the information to the caretaker.

● This has to be done in a simple language that the patient or caretaker will understand.

● Apart from this, patients have the right to know the identity and professional status of every doctor and assistant as well as the primary doctor who is treating them.

● Information regarding costs of treatment needs to be given in writing.


2. Right to records and reports


● Patients or their respective caretakers have the right to access the originals or copies of case papers, indoor patient records and investigation reports. Investigation reports have to be made available to them within 24 hours of admission or 72 hours of discharge.

● The hospital is responsible for providing a discharge summary or a death summary, in the case of a death, to the caretakers or kin of the patient with original copies of investigations.

Electronic medical records (EMR) – they are the digital equivalent of paper records, or charts at a clinician’s office.it 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.

● Perhaps the most significant benefit is that EMR records are universal, meaning that instead of having different charts at different healthcare facilities, a patient will have one electronic chart that can be accessed from any healthcare facility using EMR software.

● EMR software systems will provide links to articles, videos, and images that can help patients better understand their specific healthcare situation. With this technology, patients can make more informed decisions about medical procedures and lifestyle adjustments.

● Using EMR systems, patients can quickly and easily receive electronic copies of their healthcare information upon request.


3. Right to emergency medical care


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


4. Right to informed consent

Informed consent in ethics usually refers to the idea that a person must be fully informed about and understand the potential benefits and risks of their choice of treatment.

An uninformed person is at risk of mistakenly making a choice not reflective of his or her values or wishes. It does not specifically mean the process of obtaining consent, or the specific legal requirements, which vary from place to place, for capacity to consent.

Patients can elect to make their own medical decisions or can delegate decision-making authority to another party. If the patient is incapacitated, laws around the world designate different processes for obtaining informed consent, typically by having a person appointed by the patient or their next of kin make decisions for them. The value of informed consent is closely related to the values of autonomy and truth telling. In emergency cases, the consent of patient is not a mandatory ethic.

In Dr. T.T. Thomas vs. Elisa, the patient was admitted to the hospital with a severe case of perforated appendix. The doctors refused to operate on the patient, as they did not get the patients consent and the patient died after 3 days. The court held that in emergency operations where a doctor cannot wait for the consent of his patient or where the patient is not in a fit state of mind to give or not to give a conscious answer regarding consent.

5. Right to confidentiality, human dignity and privacy


Confidentiality is commonly applied to conversations between doctors and patients. This concept is commonly known as patient-physician privilege. Legal protections prevent physicians from revealing their discussions with patients, even under oath in court.

● 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.”