Health Laws, Ethics and Regulations

K V Ramesh M.Phil, MBA, MCom, LLB, PGDT, PGDPM Asst. Professor

Coordinator MBA (PE) Institute of Public Enterprise

Planner

Establishment, registration and regulation of health care organization.

Hospitals and labour enactments.

Hospital services and law.

Medico legal issues.

Focus onWhy health

Relevance of health

Health advancements

Why poor functional status of health

New look to health

Introduction

Improvement in the health and nutritional status of the population has been one of the major thrust areas for the social development programs of the country.

This was to be achieved through improving the access to and utilization of Health, Family Welfare and Nutrition services with special focus on under served and under privileged segments of the population.

Over the last five decades, India has built up a vast health infrastructure and manpower at primary, secondary and tertiary care in government,

voluntary and private sectors.

Health refersto body or mind and absence of disease or abnormality.state of complete physical, mental, and social well-being and not merely an absence of disease or infirmity.state of well-being that takes into account an individual's physical, mental, and emotional vitality and desires. to strength and wealth of a person.primarily a measure of each person's ability to do and become what he wants to become. 

• Institutions are manned by professionals and paraprofessionals trained in the medical colleges in modern medicine and ISM&H and paraprofessional training institutions.

• The population has become aware of the benefits of health related technologies.

• for prevention, early diagnosis and effective treatment for a wide variety of illnesses and accessed available services.

Technological advances and improvement in access to health care technologies, which were relatively inexpensive and easy to implement, had resulted in substantial improvement in health indices of the population and a steep decline in mortality.

the country produces every year 28,158 doctors in modern system of medicine of the 270 medical colleges and similar number of ISM&H practitioners and para professionals

there are huge gaps in critical manpower in institutions providing primary healthcare, especially in the remote rural and tribal areas where health care needs are the greatest.

In rural areas there is less than one female allopathic doctor per 10000 population while in urban areas it is 6.5doctors. ( May 15th ,2012)

India has least doctors per population of 10,000

Factors responsible for the poor functional status of the system

• mismatch between personnel and infrastructure.

• lack of Continuing Medical Education (CME) programmes for orientation and skill up gradation of the personnel.

• lack of appropriate functional referral system.

• absence of well established linkages between different components of the system.

As the country undergoes demographic and epidemiological transition, it is likely that larger investments in health will be needed even to maintain the current health status because tackling resistant infections and non-communicable diseases will inevitably lead to escalating health care costs.

Last two decades have witnessed explosive expansion in expensive health care related technologies, broadening diagnostic and therapeutic avenues.

Increasing awareness and rising expectations to access these have widened the gap between what is possible and what is affordable for the individual or the country.

Policy makers and programme managers realize that in order to address the increasingly complex situation regarding access to good quality care at affordable costs

It is essential to build up an integrated health system.

Appropriate screening, regulating access at different levels and efficient referral linkages.

Importance of health as a critical input

• essential primary health care, emergency life saving services, services under the National Disease Control Programmes

• National Family Welfare Programmes totally free of cost to all individuals and

• essential health care service to people below poverty line based on their need and not on their ability to pay for the services.

Right to HealthRight to medical careRight to responsibility for healthRight to a healthy environmentRight to foodRight to procreate artificial inseminationRight not to procreate family planning, sterlisation, legal abortionRights of the deceased persons i.e., determination of death, autopsies, organ removalRight to die i.e., suicide, hunger strike, discontinuation of life support measures.

What is Law ?

The word Law is a general term and has different connotations for different people.

 Examples:

1. A citizen may think of Law as a set of rules which he must obey. 2. A legislature may look at Law as something created by him.3. A judge may think of law as guiding principles to be applied in making

decisions. Rules of conduct, if recognized by the state and enforced by it on people is

treated as law. Object of Law: The Object of Law is order, and the result of order that

men are enabled to look ahead with some sort of security as to the feature.

Ethics• Ethics is a branch of philosophy that deals with values as they relate to

human conduct it is study of what is Good and right for the people.

• It is the science of morals.

• How should I act, especially when my actions directly or indirectly affect the others.

• Ethical standards affect a hospitals competitive position and strength the most common motives given for implementing ethics initiatives is to provide guidelines for employees conduct and to be socially responsible, to improve public image and motivated by profit.

Guidelines of EthicsGuidelines call on organizations to create effective programs to prevent and detect violations of law. The programs must include:

• Established compliance standards• Specific individual (S) assigned to oversee compliance • Due care in delegating discretionary authority• Steps to communicate standards and procedures i.e., training

programs and publications• Steps to achieve compliance i.e., monitoring, Auditing, and

Reporting Systems• A record of consistent enforcement of standard• Procedures to review and modify the program after an offense

When faced with ethical dilemmas, I should ask myself

• Have I looked at the problem from the perspective of all the effected parties whose interests have priority.

• Who will be harmed and who will be helped. Is there an alternative course of action that will minimize harm.

• If I act Unethically, can I get away with it.

• Am I confident that my decision will seem as reasonable over a long period of time as it does now.

• Would I be willing to disclose my decision to my boss, the general public and my family.

If my dilemma is still unresolved you should

•   Consult your company’s written ethics policies

• Use your companies hotline or help Line

• Talk to your company’s ethics officer.

• Call your Mother.

Ethics Mandatory Recently APMC has made it mandatory for pass-outs to

procure Ethics Awareness Certificate, while registering to practice medicine in state.

A good doctor must be able to have a moral bend in life and that’s why such lessons are vital says Former Principal of GMC Dr. Pradeep Deshpande.

On 7th August, 2008 about 300 doctors of the 2002 batch from the college were given similar certificates on Ethics Awareness.

Ethics committee• The first official guidelines for the formation of ECs was issued by

the Indian Council for Medical Research (ICMR) in February 1980.

• Guidelines included recommendations for membership criteria and ethical standards for review, which laid down the foundation for the establishment of ECs in India.

• This was followed by release of the ICMR guidelines in bioethics, which was a guidance document for research in medical, epidemiology, and public health, in the year 2000, which was further revised in 2006.

Ethics committee

Ensure protection of the rights, safety and well-being of human.Ensure protection to subjects involved in a research project on drugs, devices, procedures from possible harm and preserve their rights Provide public assurance of that protection.To facilitate high quality research in the hospital.

Composition of Ethics Committee

• Chairperson, Co-Chairperson, a Member Secretary

• Minimum of 7-maximum of 15 active members who represent an appropriate balance of professional, ethical, legal, cultural, educational, and community interests.

Registration of ECs• Compulsory for all Ethics Committees (ECs) clinical trials to

be registered with the Drugs Controller General of India.• The decision of DTAB is supposed to promote best practices

in the arena of clinical research in the country. • The DCGI had made the registration of clinical trials

mandatory in the country almost two years ago.• This move is in line with our efforts of building a sound

regulatory framework that would assist in setting new benchmarks for clinical practices in India.

• Help increasing transparency in terms of subject recruitment, consent process, independence of the Ethics Committee

Reality

Establishment Company.

Private company.

Public company.

Company limited by Shares.

Company limited by Guarantee.

RegistrationRegistration is effective by ROC on submission of following documents. Memorandum of association.

Articles of Association.

Qualification shares.

Agreements if any, entered.

Declaration.NOTE: http://www.mca.gov.

Indian Medical Council Act 1956

The IMC is an appellate body. It consists of number of members of the profession elected from each State, each University and some other nominated by the central government. They hold office for a term of Five Years. A president and vice president are elected from among these members.

The council covers only allopathic medical practitioners with it.

Functions :1.Medical Register2.Medical Education3.Recognition of foreign medical qualifications.4.Appeal against disciplinary action5.Warning Notice

Hospital as Industry

It was viewed as EXCEPT for the birth of a child, hospital visits are more often than not unpleasant.

If we have been lucky (with the patient's recovery, accurate diagnosis and timely treatment and service), we look back with a sense of relief.

But if it has been a disastrous experience we would rather take pleasure in spreading the good word about.

Increase in the number of service providers, cost of service delivery, emphasis on cost-containment, changing preferences of customers, changing methods of service delivery and incidences of failure in implementation of TQM are a few factors that are bringing a paradigm shift in the hospital industry from TQM to CQI (Continuous Quality Improvement) and TPM (Total Productivity Management)

Patient satisfaction studies can help in assessing services provided on hospital using specific parameters and rating scales but that is not a precise method of bench marking quality standards in different operations of the hospital.

In a hospital, a customer/patient can access the quality of service provided on three dimensions namely Structure, Process and Outcome.

What is CQI?It is defined as — ‘‘Continuous quality management is a sustained effort to streamline operations with an objective of standardization, cost containment and customer satisfaction through input of available resources.”

Continuous quality improvement is not a tool to generate revenues but it helps in increasing the patient base by providing a brand identity in community which is being served by hospital and thereby increasing the patient turnover.

TPM Total productivity management views a hospital as a

group of strategic service unit (SSU), each SSU with individual resource input, methods of productivity assessment, measures to enhance productivity in terms of volumetric turnover and control mechanism for quality improvement and maintenance.”

Ambulatory care department, clinical pathology, radio-diagnosis, intensive care unit, operation theatre suits can be better utilised by applying strategic service unit concept.

TPM and CQI concept help in important decisions regarding resource allocation, design and physical layout, furniture and fixtures, manpower allocation and utilisation, statistical control and also enables a continuous movement towards delivering services according to expectations of patients.

As compared to TQM, CQI and TPM concept is more cost contained, result oriented, generates output that can be measurable and therefore provides motivation to employees in achieving the mission of quality services at a price that is affordable to the hospital as well as community through utilisation of available resources.

The Indian healthcare sector has been growing at a pace in the past few years. The windfall began ever since the developed world discovered that it could get quality service for less than half the price.

The sector is expected to post the highest year-on-year growth in earnings.

Factors propelling the growth

• rising income levels

•changing demographics and illness profiles

• a shift from chronic to lifestyle diseases

An Industry for Future

• The voluntary health insurance market is growing fast. • Indian pharmaceutical market is set to witness medium-

term growth. The sector is expected to grow at 15.3 per cent from 2011-12 to 2013-14.

• However, it is not only the cost advantage that keeps the sector ticking. It has a high success rate and a growing credibility

• Provides first world treatments at third world cost.

Healthcare highly neglected sector

Major challenges Investment of Rs.50,000 crores in next two decades. Add 1,00,000 beds.Double number of doctors from 0.7 million to 1.5 million.Triple nurses from 0.8 million to 2.5 millionQuadruple paramedics from 2.5 million to 10 million.

Facts• The Indian healthcare sector is expected to reach US$ 100 billion by

2015 from the current US$ 65 billion, growing at around 20 per cent a year.

• According to a report by Price Waterhouse Coopers, an estimated 189 million people in the country will be more than 60 years of age by 2025, needing higher healthcare spends.

• Electronic medical record (EMR) services have a high growth potential at an estimated compound annual growth rate (CAGR) of 13.5 per cent from 2009 to 2016. With many new private hospitals opening in the next few years, investment in EMR is expected to become a necessity for these hospitals.

Booming sector India will need as many as 1.75 million additional beds by the end of 2025. Further, an investment of US$ 86 billion is required to achieve 1 doctor, 2 beds and 2.3 nurses per 1000 population by 2025.

medical tourism is expected to generate revenue around US$ 3 billion by 2013, growing at a CAGR of around 26 per cent during 2011–2013. The number of medical tourists is anticipated to grow at a CAGR of over 19 per cent during the forecast period to reach 1.3 million by 2013.

health insurance premium is expected to grow at a CAGR of over 25 per cent for the period spanning from 2009-10 to 2013-14.

Sector facts• FDI inflow in hospital and diagnostic centres was US$

1.4 billion during April 2000 and June 2012, according to the latest Department of Industrial Policy & Promotion (DIPP) data

• FDI inflow in medical and surgical appliances stood at US$ 523.5 million during the same period, according to the latest DIPP data

• The drugs and pharmaceuticals sector has attracted FDI worth US$ 9.6 billion between April 2000 and June 2012

Sector future• The Government of India has decided to increase health

expenditure to 2.5 per cent of gross domestic product (GDP) by the end of the Twelfth Five Year Plan (2012-17), from the existing 1.4 per cent.

• 100 per cent FDI is permitted for health and medical services under the automatic route.

• The National Rural Health Mission (NHRM)’s allocation has been proposed to be increased to US$ 3.72 billion in 2012-13 from US$ 3.23 billion in 2011-12.

Ratings India's independent credit rating agency CRISIL has

assigned a grade A rating to super speciality hospitals like Escorts and multi-specialty hospitals like Apollo.

• NHS of the UK has indicated that India is a favoured destination for surgeries.

• The British Standards Institute has now accredited the Delhi-based Escorts Hospital.

• Apollo Group — India's largest private hospital chain and Escorts Hospital are now seeking certification from the US-based Joint Commission on Accreditation of Healthcare Organisations.

Global forays

Indian healthcare is all set to go global with a host of domestic hospital chains busy scripting overseas expansion plans.

Major thrust of a hospital is to design hospitals to make them more hospitable to create a pleasant and sustaining environment.

Hospitals must create a healing environment.

On the radar are destinations as far as the US, the UK and Mauritius, with countries in west and south-east Asia in between.

Objectives of 21st Century hospital

1.To provide multi – and super – speciality medicare under one roof by adopting a holistic approach.

2. To provide health care based on state-of-the-art technology and expertise, at optimum cost, insuring value for money.

3. To provide a delightful ambience and excellent medicare with a human touch, by integrated team work and effective quality systems, with monitoring and feed back.

4. To carry out continuous up gradation of technology and human resource development activities in a cordial and safe environment.

5. To be an environment friendly, socially, and ecologically, conscious organization.

Challenges of Hospitals in 21st Century

1.Resources: Toughest challenge in this century will be the management of resources

2.Quality: Provide quality services to the community has increased manifold as there is a lot of awakening in the society about the quality of the services.

3.Productivity: Focus on Strategies and derived operational programs give strength and weaknesses in the competitive world.

4.Privatization

5.Legal Challenges: The public is fast becoming conscious of its rights in every walk of life including medical care.

6.Technological Revolution: Latest developments are to be updated so as to give best-state-of-the-art services to the patients.

6.Technological Revolution: Latest developments are to be updated so as to give best-state-of-the-art services to the patients.

7.Telecommunication Revolution: Focusing on transfer of clinical and management information, sharing of patient records, diagnostic information and database across hospitals using tele-medicine can open new horizon.

8.Health Insurance

9.Innovative Hospital Models: Involving active participation of care providers, mangers and so on.

10.Primary Health Care: Implementing number of programs i.e., Ministry of Health and Planning.

Indices for Measuring the Efficiency of Hospital:

1. Bed Occupancy Ratio = No. of Patients Days during the Year

No. of Bed Days during the Year * 100

2. Average Cost of Medicines for a Patient = Total cost of medicines for inpatient for the Year Total Number of Inpatient Admissions

3.Anaesthesia Death Rate = Number of Deaths due to Anesthesia

Number of Patient’s Anaesthetized during the period * 100

• 4. Post Operative Death Rate = Post operative Deaths

Total Operations during a given period * 100

• 5. Maternal Death Rate = Total Deaths of Obstetric clients Total Discharges Including Deaths of Obstetrics ward * 100

6. Maternal Mortality Ratio (MMR) is 301. i.e. 301 mothers die during delivery or within 42 days after delivery for 1 lac live births. According to UNICEF 1 women dies every seven minutes in INDIA due to pregnancy related complication.•Millennium development goals (MDG’s) to reach 106 estimates the project that INDIA will be only able to achieve an MMR of 240 by 2015.

6.Early Neonatal Death Rate = Total Deaths within first 7 Days of life

Total Viable new born discharged during the period * 100

Search for Better Indicators Continues………….

The term Unrest is to be understood from the meaning of Disturbed or UnEasy state. It is a situational factor arising out of following

1.Management

2.Politics

3.Ego

4.Patient’s

5.Technology

6.Public

Unrest

Important terms – Arbitration Act

• The person who is appointed to determine the differences and disputes is called the Arbitrator.

• The proceedings before him are called Arbitration proceedings.

• His decision is called an Award.

The Objectives of the Arbitration Act 1996.

1.To comprehensively cover international commercial arbitration and conciliation as also domestic arbitration and conciliation.

2. To make provision for an Arbitral procedure which is fair, efficient and capable of meeting the needs of the specific arbitration.

3.To provide that the arbitral tribunal gives reasons for its arbitral award.

Arbitration

4. To ensure that the arbitral tribunal remains within the limits of the jurisdiction.

5.To minimize a supervisory role of courts in the arbitral process.

6. To permit an arbitral tribunal to use mediation, conciliation or other procedures during proceedings to encourage settlement of disputes.

7.To provide that every final Arbitral award is enforced in the same manner as if it were a Decree of the Court.

8. To provide that a settlement agreement reached by the parties as a result of conciliation proceeding.

MATTERS WHICH CAN BE REFERRED TO ARBITRATION

(a) Determination of damages in case of breach of contract.

(b) Question of validity of marriage or maintenance payable to wife

(c) Question of Law (or) Law and Fact in terms of separation between husband and wife.

(d) Matters of personal or Private rights of the property.

(e) Disputes regarding compliment and dignity.

(f) Time barred claims.

Matters which can’t be referred to Arbitration

(a) Matrimonial matters Ex: Divorce

(b) Testamentary matters Ex: Validity of a will.

(c) Insolvency matters

(d) Matters relating to public charities and charitable trusts.

(e) Matters relating to guardianship of a minor (or) a lunatic.

(f) Lunacy proceedings.

(g) Matters of criminal nature (or) based on illegal transactions.

(h) Execution proceedings.

One of the Objectives of the Arbitration and conciliation is to encourage settlement of disputes arising out of legal relationship, whether contractual or not by means of mediation (or) conciliation. The term Conciliation refers to settlement of disputes in a friendly manner and through use of goodwill.

Trade Unions

Meaning: An association of workmen to protect their interest from theexploitation of the management.Definition:Trade Unions are essentially associations of workers formed to safeguard and improve the working conditions of their members and more generallyto raise their status and promote their vocational interests.

According to Trade Union Act 1926, “A Trade Union is any combination whether temporary or permanent , formed primarily for the purpose of regulating the relations between workmen and employees or for imposingrestrictive conditions on the conduct of any trade or business and include any federation of two or more Unions”.

Characteristics of Trade Unions

• Trade Union is an association, mainly of workers.

• It is relatively permanent combination of workers and it is not a temporary or casual.

The character of Trade Union has been constantly changing.

• It’s origin and growth have been influenced by a number of ideologies.

• It is an association of workers engaged in securing economic benefits for its members.

Objectives of Trade Union

To defend and improve the working conditions of workers.

To bring revolutionary changes in the political order by overthrowing capitalism.

To bring social order by replacing managerial dictatorship through

workers democracy.

Role of Trade Unions :

As an agent of the state that is a part of national administration serving its policies, a weapon of social discipline.

1.As partners in social control.

2.As a sectional bargainer.

3.As a class bargaining.

4.As enemy of the system.

Trade Unions are now accepted as a progressive element in the society to be consulted in shaping of public policy.

Complaints made by Apollo Hospital Employees

Inquiry into complaints made by Apollo Hospital Employees Union affiliated to Indian Federation of Trade Unions (IFTU),According to the complainant the Hospital authorities have violated labour laws; and have indulged in mal practices like fleecing patients. After a strike by workmen including nurses in September 1998, the management terminated the services of 161 workmen "illegally" claiming them to be trainees whose training period expired on the same day as that on which them strike started. The management also placed more than one hundred employees under suspension". The cases of all these employees are with industrial tribunals.

Unfair Labour practices & VictimizationUnfair Labour Practices – Section 25T prohibits unfair labour practices by employer or workman or a trade union. If any person commits unfair labour practice, he is punishable with fine upto Rs 1,000 and imprisonment upto 6 months. [section 25U]. Fifth schedule to Act gives list of what are ‘Unfair Labour Practices’.

IN CASE OF EMPLOYER - *Interfering in Trade Union activities.

*Threatening workmen to refrain them from trade union activities.

* Establish employer sponsored Trade Union.

* Discourage trade union activities by various means.

*Discharge or dismiss by way of victimization or falsely implicating workman.* Abolish work of regular nature and to give that work to contractors.

*Mala fide transfer of workman under guise of management policy.

* Employ badli or casuals and continue them for years.

*Recruitment workmen during strike which is not illegal.

*Acts of force and violence .

*Not implementing settlement or agreement or award.

*Refuse collective bargaining.

•Continue illegal lock-out.

LOCK-OUT

• – ‘Lock-out’ means temporary closing or a place of employment or the suspension of work, or the refusal by an employer to continue to employ any number of persons employed by him. [section 2(l)]. - - Workers go on strike, while ‘lock-out’ is to be declared by employer.

IN CASE OF WORKMEN AND TRADE UNIONS –

•Support or instigate illegal strike.

Strike – ‘Strike’ means a cessation of work by a body of persons employed in any industry, acting in combination, or a concerted refusal, or a refusal under a common understanding, of any number of persons who are or have been so employed to continue to work or to accept employment. [section 2(q)].

• Coerce workmen to join or not to join a particular trade union.

• Threatening or intimidating workmen who do not join strike.

• Refuse collective bargaining in good faith.• Coercive actions including ‘go slow’, ‘gherao’, ‘squatting

on work premises after working hours’ etc.

• Wilful damage to employer’s property.• Acts of force or violence or intimidation.

PROHIBITION OF STRIKE AND LOCK OUT IN PUBLIC UTILITY SERVICE

* In case of public utility, employees have to give at least 14 days notice for strike. The notice is valid only if strike commences within 6 weeks. Otherwise, fresh notice is required.

* Similarly, an employer cannot declare lock out without giving 14 days notice. [section 22]. If such notice is received, Government authority should be informed within five days.

Discipline means orderliness.

Discipline is the force that prompts an individual or a group to observe the rules, regulations and procedures which are deemed to be necessary to the attainment of the objective.

It is force or fear of force which restrains an individual or a group from doing things which are deemed to be destructive of group objectives.

Objectives of Discipline

1. To obtain willing acceptance of the rules.

2. To develop a sense and spirit of tolerance and adjustment.

3. To give and seek direction and responsibility.

4. To create an atmosphere of respect for human.

Body of principles governing disciplinary matters

The various Acts has led down on Disciplinary actions namely

- Industrial Dispute Act 1947.

- Payment of Wages Act 1936.

- The Industrial Employment (Standing orders) Act 1946 stipulates the broad guidelines to be followed in dealing with employee misconduct.

This Act requires “all industrial undertakings employing 100 or more persons to prepare draft standing orders, covering areas such as classification of workers, shift-working, holidays, leave rules, wage rates, rights and liabilities of employer and workers in case of closure, disciplinary action, etc.

Substantive Rules

The usual types of misconduct which appear in Standing Orders are as follows: 1.Willful insubordination or disobedience of any lawful and reasonable order of a superior.2.Theft, fraud or dishonesty in connection with the employer’s business or property.3. Willful damage4. Taking or giving bribes or any illegal gratification.5.Habitual absence without leave or absence without leave for more than ten days.6. Habitual late attendance.7. Habitual breach of any law applicable to the establishment8. Habitual negligence or neglect of work.9.Frequent repetition of any act or omission for which a fine may be imposed10.Participating in a strike.

Disciplinary action may be imposed for all types of misconduct, one of the most prevalent types in Indian Industry is absenteeism. i.e., unauthorized absence of the workers from his job.

Penalties:

A wide range of penalties, from oral warning to dismissal as a disciplinary action. The levy of extent of disciplinary action to be taken against erring employee depends upon the gravity of offence and extent of employees involvement.

Remedies for Wrongful disciplinary actions: Internal appeals

External appeals

Guidelines of a Disciplinary Action1. Location of Responsibility.

2. Proper formulation and Communication of Rules.

3. Rules and Regulations should be reasonable.

4. Equal treatment

5. Disciplinary Action should be taken in private

6. Promptness in taking disciplinary action

7. Innocence is presumed

8. Get the facts

9. Action should be taken in a cool atmosphere

10. Natural justice

Requisitions of a valid Disciplinary Action

1. Preliminary investigation

2. Issue of charge sheet or show cause notice

3. Suspension pending enquiry, if needed

4. Notice of Enquiry

5. Domestic Enquiry

6. Conduct of Enquiry

7. Recording of findings by the Enquiry Officers

8. Awarding punishment – Minor & Major

9. Communication of punishment

Two doctors shifted

• Government Hospital at Sadasivapet, doctors were transferred on disciplinary grounds on Jan28th,2011.

• Collector conducted a surprise visit on Dec15th,2010 and found Dr. V. Balaji Pawar and Dr. G. Mallikarjuna Swamy absent.

• It was found that Dr. V. Balaji Pawar was running a private nursing home.

Discipline should be like your shadowIt should follow you wherever you go

Health as two components namely extending life and extending the period of good quality life.

The hospital services provides basic descriptive data on the organization and operation of the medical care system.

It also analyses the likely relationship between and among components as shown below.

HEALTH SERVICES

Disciplinary Research Health Services Research Public Health ResearchClinical ResearchBio-Medical Research

Theory Organisms Individuals System Community

The Indian Contract Act 1872

The law of contract is that branch of law which determines the circumstances in which promises made by the parties to a contract shall be “legally binding on them”.. It is the most important branch of business law and introduces definiteness in business transactions.

According to Sec. 2 (h) defines a contract as an agreement enforceable by lawContract = Agreement + Enforceability at law.

Classification of Contracts:Express Contract Implied Contract

Quasi-contract E-Commerce Contract

ESSENTIAL ELEMENTS OR REQUISITES OF A VALID CONTRACT

According to Sec 10 all agreements are contracts if they are made by the free consent of parties competent to contract, for a lawful consideration and with lawful object and are not expressly declared to be void1.Offer and Acceptance.2.Intention to create legal relationship.3.Lawful consideration.4.Capacity of the parties.5.Free and genuine consent.6.Lawful object7.Agreement not declared void.8.Certainity and possibility of performance.9.Legal formalities

THE INDIAN MEDICAL COUNCIL(PROFESSIONAL

CONDUCT, ETIQUETTE AND ETHICS)

REGULATIONS, 2002

1.Code of Medical Ethics > Declaration , Duties & Responsibilities.

2.Character of Physician > Shall uphold the dignity and honour of his profession.

3. Maintaining good Medical Practice >Physicians should merit the confidence of patients entrusted to

their care, rendering to each a full measure of service anddevotion.

• Should affiliate with associations and societies of allopathic medical professions and participate in professional meetings and programs for at least 30 hours every 5years shall be informed regularly to MCI or SMC’s as the case may be.

• 4.Maintenance medical records > Efforts shall be made to computerize the medical records for

quick retrieval. > Medical Records pertaining to patients for a period of 3 years

from the date of commencement of treatment.

• 5. Display of Registration Numbers

6.Use of Generic Names of Drugs• > Prescribe drugs as far as possible with generic names and

shall ensure that there is rational prescription and use of drugs.

7. Highest Quality assurance in patient care > Not Employing in Exercise of professional practice any attendant who is neither registered nor enlisted under the medical list and shall not permit such persons to attend, treat or perform operations upon patients.

8. Exposure of Unethical conduct

9.Payment of professional services > Priority to the interest of the patients. > Financial interests should not conflict with the medical interests of the patients.

NO CURE NO PAYMENT

10.Evasion of legal Restrictions > A physician should observe the provisions of the State Acts like * Drugs and Cosmetics Act 1940.

* Pharmacy Act 1948. * Narcotic Drugs & Psychotropic substances Act 1985.

* Medical termination of Pregnancy Act 1971. * Transplantation of Human Organ Act 1994. * Mental Health Act 1987. * Environmental protection Act 1986. * Pre-natal Sex Determination Test Act 1994.

* Drugs and Magic Remedies( Objectionable Advertisement) Act 1954. * Persons with Disabilities Act 1995. *Bio-Medical Waste(Management and Handling) Rule 1998

• Recent amendment on January 1st,2010 Doctors can’t accept gifts or travel facility from any pharmaceutical company or the health care industry.

• A doctor will not endorse any drug or product of the industry publicly.

• A medical practitioner may carry out, participate in or work in research projects funded by pharmaceutical and allied health care industries provided the project has due permission from the competent authorities and clearance from an institutional ethics body.

Duties of Physicians

1. Obligations to the sick > Physician should be Mindful of the high character of his

mission and the responsibility he discharges in the course of his professional duties.

2. Patience, delicacy & secrecy

3. Prognosis > The Physician should neither exaggerate nor minimize the

gravity of patients condition. > Provide knowledge about the patients condition.

4. Patient must not be neglected

UnEthical Acts

A physician shall not aid or abet or commit any of the following actsWhich shall be construed as UnEthical

1.Advertising* Printing of self photograph or any such material of publicity in

the letter head regarded as acts of self advertisement.2. Patent and Copy Rights

* The benefits of patent and copy right are not made available in the interest of large population.3. Running an open shop(i.e., dispensing of drugs and appliances by physician4. Rebates and commission

5. Secret Remedies

* The Prescribing by a physician of secret remedial agents of which he does not know the composition.

6. Human Rights* The physician shall not aid or abet torture or inflict the

same by some other person in clear violation of human rights.

7. Euthanasia* Practicing euthanasia shall constitute unethical conduct

Article 21 • Right to life and liberty Supreme court on 25th Jan,2011 admitted a case filed by friend

of Aruna to examine plea of woman hospitalised for 37 years King Edward memorial hospital, parel, Mumbai.Since 1973 Aruna Ramachandra shanbaug.Working as Staff nurse.Assaulted and strangulated her by a sweeper Brain cells got damaged, bones became brittle, wrists were twisted inwards, and fingers bent at the joints and fisted into the palms.Teeth have decayed.She is now 60 years and there is no possibility of any improvement in her condition.

Agony continues• In December 2009, Dr Amar Ramaji Pazare,

Professor and head stated to the bench that “ Aruna accepts food in normal course and responds by facial expressions, nursing staff identifies and attends to her.

• The bench appointed three doctors from Mumbai.• J.V. Divitia professor and head dept of Aneasthesia,Critical

care and pain , TMH.• Dr.Roop Gursahani, Consultant neurologist, P.D. Hinduja

Hospital.• Dr. Nilesh Shah, Professor and head, Dept of Psychiatry,

Lokmanya Tilak Municipal Corportion Medical College and General Hospital.

Verdict on 7/3/2011

• The Apex court held “since there is no law presently in the country on euthanasia, mercy killing of terminally ill patient “under passive euthanasia doctrine can be resorted to in exceptional cases.”

• Apex court rejects the case.

A medical practitioner is however permitted to make a formal announcement in press regarding the following .

1.On starting practice.

2.On change of type of practice.

3. On changing Address.

4. On temporary absence from duty.

5.On resumption of another practice.

6. On succeeding to another practice.

7. Public declaration of charges.

Physicians and Patient Relationship

Patient doctor relationship is central to the patient satisfaction and positive to health outcomes.

The relationship between the patient and the doctor should be based primarily on faith, confidence and holistic approach.

The most crucial healing element is not medicine or surgery, but patient doctor relationship which provides hope, confidence and a healthy environment.

An Implied contract: The patient-doctor relationship is defined all over the world by “Code of Medical Ethics”.

Partnership: The relationship between a doctor and a patient is based on the concept of “Partnership and collaborative effort”. Decisions should be made through frank discussion, in which the doctor’s clinical expertise and the patient’s individual needs and preferences are shared, to select the best treatment option.

A legal contract: Foundation lies in a consent and a contract emerging there from. The consent is a contract between a doctor and a patient may be expressed or implied.

Duties towards patients by medical and paramedical staff

“ Patients are Emotional, Unreasonable and Spiritual”.

Doctors are Self centered, no tolerance to deviation.

o Duty to exercise a reasonable degree of skill and knowledge.

o Duties with regard to attendance and examination.

o Duty to furnish proper and suitable medicines .

o Duty to give instructions.

o Duty to control and warn.

oDuty to inform patient of risks.

o Duty with regard to Poisons.

o Duty to notify certain diseases.

o Duties with regards to Operations.

o Duties under Geneva conventions.

o Duties with regard to consultation.

o Duties in connection with X-ray examination.

o Professional Secrecy.

THE TRANSPLANTATION OF HUMAN ORGANS ACT 1994

In 1994, the Transplantation of Human Organs Act (THOA) was passed as a response to the concerns raised about this growing trade in human organs (Government of India, 1994) and tissues for therapeutic purposes . This Act was seen as necessary in curbing the purchase of organs from live donors.

Commercial dealings, like indulging in monetary transaction for trading in human organs, brokering human organ trade deals, and advertising to solicit clients, are punishable with imprisonment ranging from two to seven years, and a fine of Rs 10,000.

The main aspects of the Act

1. It aims at putting a stop to live unrelated transplants.

2. In case of live related transplant, it defines that the donor and the recipient are genetically related, with an exception if the transplant is done with prior approval of the Authorization committee on an application jointly made by the donor and the recipient.

3. It accepts the brain stem death criterion.

Certification of death by a panel of experts is essential.

Both the donor and recipient are interviewed separately by the AC. The primary purpose of this meeting is to ensure that the donor is not coerced or influenced by monetary considerations.

Typically, the committee members ask donors the following questions:

1. ‘What motivates you to donate your kidney?’; 2. ‘How are you related to the recipient?’; 3. ‘Has the recipient assured you that she/he will take care of your

health after donation?’;4. ‘Has the doctor fully explained to you the possible after effects of

donating your kidney?’

Typical donors’ answers to these questions are

• ‘I will donate my kidney out of affection or attachment, not for any financial reasons’;

• ‘The recipient is related to me’; • ‘I am confident that the recipient will take

care of my needs in future’; • ‘I am fully aware of the possible

consequences of donating my kidney.

Important Definitions

•Transplantation means the grafting of any human organ from any living person or deceased person to some other living person for therapeutic purposes.

•Human Organ: Means any part of human body consisting of structured arrangement of tissues which, if wholly removed cannot be replicated by the body.

•Deceased Person: Means a person in whom permanent disappearance of all evidence of life occurs, by reason of brain-stem death or in a cardio-pulmonary sense, at any time after live birth has taken place.

• Therapeutic Purposes: to improve health according to any means systematic treatment of any disease or the measures particular method or modality.

• Brian-Stem Death: Means the stage at which all functions of brain-stem have permanently and irreversibly ceased and is so certified.

• Donor: Means any person, not less than 18 years of age (minor) , who voluntarily authorizes the removal of any of his organs for therapeutic purposes. Recipient: Means a person into whom any human organ is, or is proposed to be, transplanted.

2011

• Human Organ Retrieval Centre” means a hospital,

• which has adequate facilities for treating seriously ill patients who can be potential donors of organs in the event of death; and

• which is registered under sub-section (1) of section 14 for retrieval of human organs

• “near relative” means spouse, son, daughter, father, mother, brother, sister, grandfather, grandmother, grandson or granddaughter.

• “tissue” means a group of cells except blood performing a particular function in the human body.

• Tissue Bank” means a facility registered under section 14A for carrying out any activity relating to the recovery, screening, testing, processing, storage and distribution of tissues, but does not include a Blood Bank.

• “transplant co-ordinator” means a person appointed by the hospital for co-ordinating all matters relating to removal or transplantation of human organs or tissues or both and for assisting the authority for removal of human organs in accordance with the provisions of section 3.

No registered medical practitioner shall undertake the removal or transplantation of any human organ unless he has explained all possible effects, complications and hazards connected with the removal and the transplantation to the donor and the recipient.

In case of unclaimed bodies in hospital or prison, organs can be removed after 48 hours.

The problem with the Act is that it tried initially to balance the interests of different parties and was therefore bound to fail.

The Act provides punishments for any unauthorized Act, with imprisonment for a term which may extend to 10 years and with a fine which may extend to Rs.20 lakhs. The State Medical Council can take necessary action including the removal of his name from the register for a period of two years for the first offence and permanently for the subsequent offence.

The role of the AA 1.To license those hospitals involved in the removal, storage, and

transplantation of human organs.

2. Its specific functions include: registration of hospitals; suspension or cancellation of registrations; enforcement of standards; investigation into complaints of breaches of the Act; inspection of hospitals in relation to the quality of

transplantation and follow up medical care.

The Central Government and the State Governments, as the case may be, by notification, shall constitute an Advisory Committee for a period of two years to aid and advise the Appropriate Authority to discharge its functions.

The Advisory Committee shall consist of—A one administrative expert not below the rank of Secretary to the State Government, to be nominated as Chairperson of the Advisory Committee;

B two medical experts have such qualifications as may be prescribed;C one officer not below the rank of a Joint Director to represent the Ministry or Department of Health and Family Welfare, to be designated as Member-secretary

D two eminent social workers of high social standing and integrity, oneof whom shall be from amongst representatives of women’s organisation;

E one legal expert who has held the position of an Additional DistrictJudge or equivalent;

F one person to represent non-governmental organisations orassociations which are working in the field or organ or tissue donations orhuman rights;

G one specialist in the field of human organ transplantation, providedhe is not a member of the transplantation team.

The role of the AC

• In each state or union territory is to approve the transplants between unrelated donors and recipients.

• The primary duty of the AC is to establish that the unrelated donors are not under any coercion or unduly influenced by monetary considerations to donate their organs.

Failures of THOA 1994 A Cure worse than the disease 1. Private hospitals authorized to perform kidney transplantations are required to produce the donor’s before the Authorization Committee one to three months after the surgery for assessment of their well being.2. Donors from outside Tamilnadu must get a letter of approval from the AC in their states.3. Requires Human Leukocyte Antigens (HLA) matching to be conducted “in the laboratories not attached to the hospital”. 4. The Act “paints all doctors and hospitals with the same brush,” assuming that “everyone is out to dupe the AC”.

5. According to a recent study by IIT Chennai, the implementation of THOA and the present regulatory system is incapable of preventing it. The loophole in the Act is Section 9(3), which allows kidney donation on grounds of “affection and attachment”, and is therefore much exploited for the trade in kidneys.

6. Strong hospital-middlemen nexus.7. Dr. M.K. Mani of Apollo Hospitals, Chennai. If AC is

unable to prevent commercial deals in organs, then there is every reason to scrap Section 9(3), which allows for live unrelated donations on emotional grounds.

SUGGESTIONS1. Bring transparency to the functioning AA & AC.

2. Accountability & Responsibility for every decision taken by AA & AC.

3. It must break the Donor-Broker-Doctor-Hospital nexus.

4. Bill to amend Act (Nov 17th 2010) aiming

• at setting up a network for organ retrieval and transplantation

• proposal to widen the definition of relatives

• mandatory request for organ donation made in hospitals at the time of death.

• change in definition of near relatives to include grandchildren and grand parents along with current defined relatives of son, daughter, father, mother, husband and wife.

• Allow swap donation and include tissues in organ donation.

On 13th April, 2007 Licenses of two hospitals withdrawn and suspension notices issued to 13 others on the ground that they were found guilty of forging transplantation orders. It is for the first time since the enactment of the THOA 1994.

M.R hospital and Ashwani Soundarya Nursing home (Chennai) licenses have been cancelled.

CONSUMER PROTECTION ACT 1986 ( Amended in 2002):

The Act applies to whole of India except state of Jammu & Kashmir.

The main aim of the Act is to provide better protection of interest of the consumers. The Act covers all private, corporate and public sector enterprises. The following are the objectives of the Act namely

1.Better Protection of interests of Consumers.

2.Protection of rights of consumers

3.Consumer protection councils.

4.Quasi-Judicial machinery for speedy redressal of consumer disputes.

Important Definitions

Consumer [Sec. 2(1) (d)]. means any person who (i) buys any goods for a consideration (ii) hires or avails of any service for a consideration.

Consumer Dispute [Sec. 2(1) (e)]. means a dispute where the person against whom a complaint has been made, denies or disputes the allegations contained in the complaint.

Deficiency:[ Sec 2(1) (g)]. means any fault, imperfection, short coming or inadequacy in the quantity, nature and manner of performance which is required to be maintained by or under any law for the time being in force.

Service [Sec 2(1) (o)]. means service of any description which is made available to potential uses. However it does not include the rendering of any service free of charge or under a contract of personal service.

Consumer Disputes Redressal Agencies

District Forum: The District Forum shall have jurisdiction to entertain complaints where the value of goods or services and the compensation, if any, claimed does not exceed Rs. 20 lacs.

State Commission: The State Commission shall have the jurisdiction to entertain the complaints where the value of goods or services and the compensation, if any, claimed exceed Rs. 20 lacs but does not exceed Rs. 1 Crore and appeals against the orders of any District Forum with in the state.

National Commission: The National Commission shall have the jurisdiction to entertain the complaints where the value of goods or services and the compensation, if any, claimed exceed Rs. 1 Crore and appeals against the orders of any State Commission.

Procedure•Every compliant is heard as early as possible.• If the complaint relates to any services, the District Forum shall refer a copy of such complaint to the opposite party within 21 days of admission date, directing him to give his version of the case within a period of 30 days. •The dispute is settled on the basis of evidence brought to its notice by the complainant and where the opposite party denies or disputes the allegations contained in the complaint. •The District Forum has same powers as are vested in a Civil Court under the Code of Civil Procedure 1908.• Every proceeding before the District Forum shall be deemed to be a judicial proceeding of Indian Penal Code 1860.

Appeal• Any person aggrieved by an order made by the District

Forum may prefer an appeal against such order to the State Commission within a period of 30 days from the date of the order

• Any person aggrieved by an order made by the State Commission may prefer an appeal against such order to the National Commission within a period of 30 days from the date of the order. Appeal is entertained only when the appellant has deposited in the prescribed manner 50% of the amount or Rs. 35,000 whichever is less.

Any person aggrieved by an order made by the National Commission may prefer an appeal against such order to the Supreme Court within a period of 30 days from the date of the order. Appeal is entertained only when the appellant has deposited in the prescribed manner 50% of the amount or Rs. 50,000 whichever is less.

The doctors and hospitals who render service as medical practitioners are liable for any act of “Medical negligence” and they can be sued for compensation under the consumer protection act. However services rendered to all patients by way of consultation, diagnosis and treatment, both medical and surgical are given free service is outside the preview of Act.

• Negligence is defined as doing something that one is not supposed to do, or failing to do something that one is supposed to do.

• Professional negligence is defined as absence of reasonable care and skill., or willful negligence of a medical practitioner, in the treatment of patient which causes his bodily injury or death.

What is negligence ?

1. The consent is not obtained from the patient .2. The patient is not informed about material risk involved in the

treatment.3. Complaint of patient, examination finding and other reports

are suggestive of a certain diagnosis but doctor does totally different and wrong diagnosis.

4. The diagnosis is correct but treatment is wrong.5. Doctor uses a method to treat patient which is not recognised

by medical field at that time or outdated.6. Departure from the procedure for which patient has consented.

7.Doctor does not take preventive steps when there are chances of reaction by any medicine.

8.Doctor does not take immediate action when a drug causes reaction.

9.Delay in starting the treatment without proper reasons. 10.Patient is not instructed properly about precautions to be

taken.11. In embarking on giving treatment which he could not

skillfully offer.12. He should not have undertaken the treatment but should

have referred to someone possessing the necessary skill.

What is negligence ?

13. Deficiency in service at any stage of treatment.

14. Breach of any provisions of any Act.

15. RES IPSA LOQUITUR.

16.The law is not diluted for novice doctor or quacks.

In short omitting to do something which other doctor would do or doing something which other would not do.

No Negligence

1. Doctor has acted in accordance with a practice accepted as proper by the medical field.

2. Two views on a particular point and doctor has accepted one of them.

3. Often even proper medicine may not be effective, it is misfortune and not negligence.

4. Sometimes findings and other reports are so complicated that mistaken diagnosis is made. It is not negligence.

5. Mere deviation from accepted practice by an experienced doctor is not negligence.

6. Every mishaps or misadventures are not negligence.

No Negligence

7. Standard of care neither high nor low but must be an average.

8. One doctor may use one method and other doctor may use other, it is difference of genuine opinion and not negligence.

9. Mere Omission in reading an article is not negligence but it is negligence to neglect frequent warning and notice.

10. Considering time, place, Knowledge. Facilities and other circumstances.

DOCTOR CONVERTING HIS NURSING HOME INTO A BUTCHER’S SHOP.

“Mathi Surgical and Maternity Hospital”

U have to have a heart

On 29th Jan,2010 DrNK Pandey, Chairman of the Asian Institute of Medical Sciences, Faridabad says “Access to quality healthcare is every individual’s birthright but it still remains a distant reality in our country.”

There is a definite loss of confidence in the healthcare sector and an acute crisis of communication, honesty and empathy in those involved in this occupation.

March 11,2011Vandana Luthra Curls & Curves Vs Tiwari • Facts1. A resident of Kavi Nagar in Ghaziabad, had approached the

Rajdhani Enclave, Delhi centre of VLCC April 30, 1999. 2. the company had guaranteed to help him shed 30 kg weight

within a brief period. 3. The company recommended a programme and gave him

some medicines to help him slim down. 4. The company, after offering a discount of 40 percent fixed

the cost of the programme at Rs.21,600. 5. Tiwari paid the sum in two instalments through cheques on

April 30 and May 2, 1999.

6. According to Tiwari, the company prescribed him improper medicines and devised an ineffective programme that did not cause him any benefit

7. Whatever little benefit he derived was because of his own exercising and diet control, he maintained.

8. He had tried several times to contact the centre and its management but they gave him no satisfactory replies.

9. When all his efforts failed with the company, he filed a suit against VLCC in the Ghaziabad consumer forum demanding a compensation of Rs.2 lakh from it for the physical and mental loss caused to him.

Company’s view

• claimed that it had not given him any medicines or any time frame as he was alleging.

• The beauty firm maintained that it had not given any false assurances to him and that he failed to derive the benefit by not conforming to the schedule properly.

• The company also stated that Tiwari had a family history of obesity.

• and was irregular in coming to the centre for monitoring the weight loss programme and not taking it seriously.

Verdict• The forum observed that there was enough evidence to show

that the complainant made payments through several receipts, which even the company was not able to counter in its reply.

• consumer forum granted him Rs.50,000 in damages.• The district consumer court Friday directed VLCC India Ltd.

to pay the money to Saurabh Tiwari for giving him false assurances to reduce his weight.

• The forum also ordered the company to pay an interest of 9 percent on the sum of Rs.21,600 that Tiwari had paid April 30, 1999. The company has also been asked to pay the customer Rs.2,000 as charges incurred by him in the course of the case

A doctor is not liable for

• An error of judgment or diagnosis, if he has secured all necessary data on which to base a sound judgment.

• Failure to cure or for bad results that may follow, if he has exercised reasonable care and skill.

• Some risks are inherent in any form of treatment, and the doctor will not be negligent if they cause damage, provided that he has taken proper precautions.

• Doctor cannot be held liable for error of judgement – Mohd Ishfaq vs Nanavati hospital however while doctors who cause death or agony due to medical negligence should certainly be penalised.

• Mere deviation from normal professional practice is not necessarily evidence of negligence – the accused did something or failed to do something which in the given facts and circumstances no medical professional in his senses and prudence would have done or failed to do so. Kusum sharma Vs Batra hospital and medical research centre 10th Feb,2010.

Batra Hospital &Medical Research centre

Supreme Court on 10th Feb,2010 held deviation from normal practice no evidence of medical negligence.

Held in complicated cases doctors had to take a chance even if the rate of survival was low.

To prosecute a medical professional for negligence under criminal law it must be shown that the accused did something or failed to do something which in the given facts and circumstances no medical professional in his senses and prudence would have done or failed to do.

The hazard taken by the accused doctor should be of such a nature that the injury which resulted was most likely imminent.

A medical practitioner would be liable only where his conduct fell below the standards of reasonably competent practitioner in his field.

In the realm of diagnosis and treatment, there is a scope for genuine difference of opinion and one professional doctor is clearly not negligent merely because his conclusion differs from that of other professional doctor.

It is the bounden duty and obligation of civil society to ensure that medical professionals are not unnecessarily harassed or humiliated so that they can perform their professional duties without fear and apprehensions.

Held that at times medical practitioners also had to be saved from such a class of complainants who used the criminal process as a tool for pressurizing medical professionals / hospitals, particularly private hospitals or clinics, for extracting an uncalled – for compensation.

Plea for compensation of Rs.45 lakhs was dismissed by Apex court , wherein the order of National consumer disputes redressal commission challenged by Kusum Sharma and others.

Jan 23rd,2010 Udaipur• Facts of the case Doctors at Govt.hospital almost chopped off a new- born’s arm during

Cesarean section leading to the death of the baby. Pannadhai hospital defended itself saying though the baby’s arm was

“hurt”, it was not “serious”. Whole arm got cut by the blade during operation. He was lying helpless for two days without even proper dressing- baby’s

father said. Dean Dr. Kamlesh punjabi, earlier admitted that “the baby’s arm was hurt

during delivery” and said “ it was not serious, it does happen.” “Just some stitches are needed and it is not unusual”. Three member committee investigated the matter but found no negligence

on the doctors’ part. Held the baby was premature and developed septicaemia, he could not be

saved.

Justice after 17 years, trauma continues

• P. Venkata Lakshmi Vs Swapna nursing home.• PVL admitted to the nursing home to deliver her second child,

a baby girl now 18 years.• Delivered with multiple disabilities.• Alleged negligence of doctors led to child birth asphyxia,

neonatal convulsions, cerebral hemorrhages, pneumonitis, jaundice and host of other worries.“I only want my case to be an eye-opener and help spread awareness among people who have a similar predicament but do not know whom to approach or what to do.”

National consumer forum ordered for Rs.10 lakhs compensation.21st Feb,2011.

Care penalised for bad care On April 25th , 2005 a patient was admitted with symptoms of

fever, cough , giddiness and high blood pressure. On May 1st ,2005 patient was shifted from ICCU to a ward after

the condition improved. On May 5th ,2005 She developed hypertension and fever and

her condition worsened. However, the duty nurse started searching for the oxygen

cylinder which was found only after 10 Min. But there were no connecting tubes.

Care without care The nurse then went searching for the tubes losing another 10 Min.

She found them dust laden under a table and struggled to fit them on to the cylinder.

In the meantime, patient slipped into coma. She was in coma for 20 days and died on May 25th ,2005.

This case has been fought with only aim to be an eye opener for all and not for compensation.The consumer disputes redressal forum has ordered Care Hospitals to pay Rs 5 Lacs as compensation to a person for failing to provide proper medical attention to his wife.

Mix of Joy and disappointment

• A patient went to the hospital in September 1990 for a check-up as he was suffering from on and off fever for one year.

• On examination, it was noticed that he had a large mass in his left hemi thorax.

• A surgery was performed and the tumour was removed. But, post-surgery he became a paraplegic-paralysis of the lower limbs of the body.

CHARGES• The tumour being a neurogenic one, the surgery should have

been handled by a neurosurgeon.• The surgery completely disturbed the nervous system, making

him paraplegic.

Mix of Joy and disappointment

• The National consumer disputes redressal commission awarded a compensation of Rs 15.5 Lacs.

• The patient appealed to the Supreme Court for the compensation of Rs 7 Crores including interest.

• On 24th April 2008, the Apex body directed the hospital to go for an out-of –court settlement with the complainant or his father, the Director of the Institute, along with the state health secretary to explore the possibility of a settlement.

• The Bench directed that the matter be listed to July 22nd , when settlement or otherwise would be informed to the court.

• On May14th,2009 Supreme court directed the NIMS, Hyderabad to pay Rs.1 crore with 6%interest from 1999, for medical negligence when the national commission gave the award.

Kolkata hospital 22/11/2011

Anuradha, a qualified child psychologist, died in the hospital on May 28, 1998 during a social visit to India after she suffered Toxic Epidermal Necrolysis, a rare and deadly disease. TEN is an exfoliative dermatological disorder of unknown cause. A patient with TEN loses epidermis in sheet-like fashion leaving extensive areas or denuded dermis that must be treated like a large, superficial, partial-thickness burn wound.

According to the order, compensation includes Rs. 41,90,000 each against AMRI Hospital and Dr. Sukumar Mukherjee And Rs. 26,93,000 each against Dr. Baidyanath Halder and Dr. Balaram Prasad. The Supreme Court in 2009 had found these three doctors and Dr. Abani Roychowdhury responsible for Anuradha's death and remanded this case back to the NCDRC only for determination of the quantum of compensation.

• Dr. Roychowdhury died during the hearing of this case. The Commission deducted 25 per cent from this compensation amount. Further the Commission reduced 10 per cent of the amount for alleged interference by the complainant Dr. Kunal Saha in Anuradha's treatment.

The Commission rejected Dr. Saha's claim for a total compensation of about Rs. 97 crore and said “a complainant cannot be allowed to get undue enrichment by making a fortune out of a misfortune.” Though initially Dr. Saha claimed Rs. 77 crore, later he revised his claim.

It said “The theoretical opinion/assessment made by a Foreign

Expert as to the future income of a person and situation prevalent in that country cannot form a sound basis for determination of future income of such person and the Commission has to work out the income of the deceased having regard to her last income and future prospects in terms of the criteria laid down by the Supreme Court.”

• Reacting to this order, Dr. Saha expressed disappointment and said: “In order to fight this enormous legal battle for the past more than 12 years staying in America, apart from sacrificing my personal and professional lives, I have spent far more than the Rs. 1.77 crore that has been awarded by the NCDRC for the loss of a human life after this long-drawn legal battle.”

The National Consumer Disputes Redressal Commission (NCDRC) has awarded a compensation of Rs. 1. 77 crore towards medical negligence against AMRI hospital, Kolkata and three doctors for causing the death of Anuradha Saha, wife of Kunal Saha, a U.S.-based Indian doctor.

FOOD AND DRUG LAWS

Launching of various products and servicesLabeling and packaging of productsRegulatory approvalsForeign direct investment & Customs lawsIncorporation of companyTax adviceLiaisoning with government agenciesProduct Liability Consumer ProtectionIntellectual Property registrationBrand positioningConsumer incentive promotionsDue diligence-appointment of agent/distributorNegotiation of commercial dealsLegal documentation of contracts

Medico Legal Issues

1. Indian Penal Code 1860 (I.P.C): It deals with substantive criminal law of India. It defines offences and prescribes punishments.

2. Criminal procedure Code, 1973 (Cr.P.C): It provides mechanism for punishment of offences against the substantive criminal law. It deals with police duties in arresting offenders, dealing with absconders, in the production of documents, etc. and in investigating offences. It provides for different class of Courts and deals with actual procedure in trials, appeals, references, revisions and transfer of criminal cases.

3. Indian Evidence Act, 1872 (I.E.A): It deals with Law of Evidence, and applies to all judicial proceedings in or before any Court. It is common to both the criminal and civil procedures.

4. Civil Law: It deals with disputes between two individuals or parties. The party bringing the action in a civil case is called “Plaintiff”. The accused is called ‘defendant’ in both criminal and civil cases.

5.Criminal Law: It deals with offences which are considered to be against the public interest, such as offences against the person, property, public safety, security of the State etc. Here the State is a party represented by public prosecutor, and the accused is the other party.

Indian Evidence Act, 1872

Evidence means and includes all statements which the Court permits or requires to be made before it by witnesses, in relation to matters of fact under enquiry and all documents produced for inspection of the Court.

Types 1. Documentary –primary evidence or secondary evidence and includes Medical Certificates, Medico-legal Reports and Dying

declaration.2. Oral 3. Direct4. Indirect or Circumstantial5. Hearsay

Indian Penal Court 1860 relevant sections in protecting the medical doctors

Sec 81 Act Likely to cause harm, but done without criminal intent, and to prevent other harm,.—Nothing is an offence merely by reason of its being done with the knowledge that it is likely to cause harm , if it be done without any criminal intention to cause harm, and in good faith for the purpose of preventing or avoiding other harm to person or property.

Sec 88 Act not intended to cause death, done by consent in good faith for person’s benefit, —Nothing, which is not intended to cause death, is an offence by reason of any harm which it may cause, or to be intended by the doer to cause, or be known by the doer to be likely to cause, to any person for whose benefit it is done in good faith, and who has given a consent, whether express or implied, to suffer that harm, or to take risk of that harm.

Sec 89 Act done in good faith for benefit of child or insane person by or by consent of guardian , —Nothing which is done is good faith for the benefit of a person under 12 years of age, or of unsound mind, by or by consent, either or implied, of the guardian, or the other person having lawful charge of that person, is an offence by reason of any harm which it may cause, or be intended by the doer to cause or be known by the doer to be likely to cause to that person..

• Sec 90 Consent known to be given under fear or misconception. —A consent is not such a consent as is intended by any section of this Code, if the consent is given by a person under fear of injury, or under a misconception of fact, and if the person doing the act knows, or has reason to believe, that the consent was given in consequence of such fear or misconception or Consent of insane person or Consent of Child.

• Sec 92 Act done in good faith for a benefit of a person with out consent. —Nothing is an offence by reason of any harm which it may cause to a person for whose benefit it is done in good faith, even without that person’s consent, if the circumstances are such that it is impossible for that person to signify consent, or if that person is incapable of giving consent, and has no guardian or other person in lawful charge of him from whom it is possible to obtain consent in time for thing to be done with benefit.

Sec 93 Communication made in good faith. —No communication made in good faith is an offence by reason of any harm to the person to whom it is made, if it is made for the benefit of the person.

Sec 304A Causing death by negligence. —Whoever causes the death of any person by doing any rash or negligent act not amounting to culpable homicide, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine or with both.

Culpable homicide• is an offence under Sec299 of the IPC, defined as "Whoever

causes death by doing an act with the intention of causing death, or with the intention of causing such bodily injury as is likely to cause death, or with the knowledge that he is likely by such act to cause death, commits the offence of culpable homicide."

• "Culpable homicide not amounting to murder" is an offence under Sec 304 of the Indian Penal Code. It applies to an event where the death is intentional but does not come within the IPC definition of "murder". Accused charged with culpable homicide will not get bail. It is non-bailable.

Sec 304AA policeman was admitted on 10th April,2010 for laparoscopic surgery after he was diagnosed of stones in gall bladder. He was operated upon the same day and shifted to a room.However developed complications on 13th April.Prompting the doctors to shift him to CCU.While being treated died around 2 p.m.on 15th.Family members charged that the patient had no other disease and walked into the hospital on the day he was admitted and died of negligence of hospital doctors.

Criminal case : Yashoda Hospital Somajiguda Branch

Penal Provisions applicable to medical practice:

Sec 118 –Concealing design to commit offence punishable with death or imprisonment for life.

Sec 176 –Omission to give notice or information to public servant by person legally bound to give it.

Sec 177 –Furnishing false information.

Sec 178 –Refusing Oath or affirmation when duly required by public servant to make it.

Sec 179 –Refusing to answer public servant authorized to question.

Sec 182 –False information with intent to cause public servant to use his lawful power to the injury of another person.

Sec 191 –Giving false evidence.

Sec 192 –Fabricating false evidence.

Sec 193 –Punishment for false evidence.

Sec 194 –Giving or fabricating false evidence with intent to procure conviction of capital offence.

Sec 195 –Giving or fabricating false evidence with intent to procure conviction of offence punishable with imprisonment for life or imprisonment.

Sec 197 –Issuing or signing false certificate.

Sec 201 –Causing disappearance of evidence of offence, or giving false information to screen offenders.

Sec 203 –Giving false information respecting an offence committed.

Sec 204 –Destruction of document to prevent it’s production as evidence.

Code of Criminal Procedure 1973 Sec 39 –Every person, aware of the commission of, or of the intention of any other person to commit any offence punishable under I.P.C. shall forthwith give information to the nearest Magistrate or police officer of such commission or intention.

53. Examination of accused by medical practitioner at the request of police officer.(1) When a person is arrested on a charge of committing an offence of such a nature and alleged to have been committed under such circumstances that there are reasonable grounds for believing that an examination of his person will afford evidence its to the commission of an offence, it shall be lawful for a registered medical practitioner, acting, at the request of a police officer not below the rank of sub-inspector, and for any person acting in good faith in his aid and under his direction, to make such all examination of the person arrested as is reasonable necessary in order to ascertain the facts which may afford such evidence, and to use such force as is reasonably necessary for that purpose.

(2) Whenever the pet-son of a female is to be examined under this section, the examination shall be made only by, or under the supervision of, a female registered medical practitioner.

Explanation. In this section and in section 54, "registered medical practitioner means a medical practitioner who possesses any recognized medical qualification as defined in clause (l) of section 2 of the Indian Medical Council Act, 1956 (102 of 1956), and whose name has been entered in a State Medical Register.

54. Examination of arrested person by medical practitioner at the request of the arrested person.

When a person who is arrested, whether on a charge or otherwise, alleges, at the time when he is produced before a Magistrate or at any time during, the period of his detention in custody that the examination of his body will afford evidence which will disprove the commission by him of any offence or which Magistrate shall, if requested by the arrested person so to do direct the examination of' the body of such person by a registered medical practitioner unless the Magistrate considers that the request is made for the purpose of vexation or delay or for defeating the ends of Justice.

Vicarious Liability

As the surgeon is a master and other staff is working under him and does the treatment according to his instructions, the surgeon is vicariously liable for negligence of his staff .

If the paramedical staff is qualified, the surgeon cannot be held liable for their negligence unless he is their employer.

If a surgeon employs non qualified staff then he is responsible for every act of his staff.

Often surgeon gives telephonic instructions regarding patient’s treatment. Any misunderstanding about these instructions, if causes injury to the patient surgeon may be held liable.

Special CBI court- ChandigarhCase 1 • On 4Th March,2009

Cardiac surgeon of the PG Institute of Medical Education and Research, sentenced 5- year prison in a cheating and forgery case and imposed a fine of Rs.1.40 lakhs.

CBI registered a case in 2003 against Dr.R.S.Dhaliwal, Professor and head of the cardiovascular and thoracic surgery AND Surinder singh uppal, proprietor of fake firms AND Satpal singla, Proprietor of M/S Paul medical hall.

Found that Dr.Dhaliwal used to refer the patients or their wards to S.S.Uppal, who used to collect either cash or bank DD in favour of his non-existent firms.

Used to supply cheap valves and share the money with Dr.Dhaliwal and also issued fake bills to justify the amount received from the patients and their wards.The investigation specified 24 instances.In certain cases the surgeon obtained the cost of 2 valves but implanted only one.He also forged records.Established that DR.Dhaliwal used to send requisitions for costlier brand of valves but implanted cheaper brands supplied by Mr.Singla.Mr.Singla used to issue fake bills.

VerdictConvicted both Dr. Dhaliwal and Mr. Singla for the offences of criminal conspiracy, cheating, forgery, use of forged documents and offences under the Prevention of Corruption Act.Dr.R.S.Dhaliwal for FIVE year prison.Mr.Singla to undergo TWO years rigorous imprisonment and pay a fine of Rs. 50,000. Mr.Uppal granted pardon as he admitted his guilt and confessed to the crime committed by him.

Law of Tort

Certain duties are imposed on every person in the society irrespective of

monetary consideration. If a doctor commits an act which other reasonable doctor of his standard would not commit or the doctor omits to do something which

other doctor would certainly do is a negligent act.

Case 2 :Doctors to face trial in medical negligence -26/October/12

• The complainant, Munni, had taken her daughter, Neeru Chauhan, to IHBAS for treatment of the girl’s epilepsy condition on July 12, 2008.

• Munni alleged that the respondents had asked that an MRI be done and meanwhile, two injections were administered on her daughter’s left hand upon which it turned blue and swelling occurred.

• The case was referred by the IHBAS to GTB Hospital from where it was further referred to AIIMS and lastly to Safdarjung Hospital.

• It was detected that the veins of left hand of the complainant's daughter had been blocked allegedly due to wrong administration of injection.

• Four fingers from Neeru’s left hand had to be amputated, three of which had been affected by gangrene.

• The mother then approached the trial court for prosecution of the doctor concerned.

• The complainant had examined herself and her daughter besides two surgeons from the Safdarjung Hospital and GTB Hospital as witnesses for pre-summoning evidence.

• Both doctors while certifying the complainant’s version that she had visited the two hospitals - upon reference from IBHAS - said that the injections given in IHBAS “probably contributed” to Neeru’s condition.

• The Magistrate chose not to summon the doctor responsible after ruling that no “concrete” evidence was provided by the two witness doctors. The Magistrate also noted that the witnesses had not stated what was the line of treatment which should have been advised and which was not adopted.

• Additional Sessions Judge T. S. Kashyap said in his order that at the stage of summoning the testimony of the two doctors was sufficient to form an opinion because no doctor would be in a “position to say anything concrete”.

• The Sessions court said the magistrate has “misinterpreted the judicial authority on the facts of this case and therefore the impugned order deserves to be set aside”. The court sent the case file back to the trial court with the direction to summon the accused persons to face the trial for the offence under Section 338 (causing grievous hurt by act endangering life or personal safety of others) of the Indian Penal Code.

• Sessions court has summoned the head of department and a doctor of the Institute of Human Behaviour and Allied Sciences to face trial in a case of alleged medical negligence after setting aside a magistrate’s order dismissing the complaint.

Doctor in the Court

Case 3 : Smt.Hema menani Vs Dr.Mahesh Shah 2006

Chattisgarh state consumer disputes redressal commission, Raipur.Complaint:

1. Smt fainted on 21-4-2003 and was admitted in the nursing home of Dr.Shah at about 10.30a.m.

2. Dr. told relatives that it is a case of poisoning and it is necessary to inform the police.

3. Dr. asked to deposit Rs.10000. Relatives deposited Rs.8000.4. As there was no improvement, relatives called Dr.R.S.Sharma

who inquired from Dr. as to what tests were performed. Dr. replied that no tests were performed.

Negligence5. On 22-4-2003,Dr. demanded Rs.5000 but he did not tell as to what for

the amount was required.

6. Relatives contacted Dr.Malhotra before shifting to his nursing home. Relatives demanded treatment papers from Dr. However, Dr. tore the treatment papers into pieces, kept them in his mouth and chewed them.

7. Relatives took the patient to Dr.Malhotra’s nursing home on 22-4-2003, at 11.30a.m.

8. Dr.Malhotra told that it is a case of Brain Hemorrhage, advised CT Scan and called Neurologist Dr. Sanjay Sharma.

9. On 23-4-2003, Patient’s breathing became inconsistent. She was referred to MMI Hospital where she died on 25-4-2003.

Negligence10. Alleged that patient died because of negligence of Dr.Shah who did not perform

necessary tests and gave wrong treatment.11. Compensation of Rs.15 lacs demanded.DEFENCE1.He believed that it was a case of poisoning, Symptomatic treatment was started.

As there was no improvement, dose of medicines was increased and the patient was kept under his observation.

2. CT Scan was advised on 21-4-2003 itself and Rs.5000 were demanded for CT Scan.

3. It is denied that treatment papers were torn and chewed by Dr.Shah.4. Dr.Malhotra had also given almost same treatment.District forum decisionNo deficiency on part of doctor and complaint dismissed.

NegligenceAppeal by complainants to State commission.Findings:1.It is clear from the documents that Dr.Shah has started a treatment

without conducting any test.

2. Dr has not made it clear as to what he has done to evaluate the patient’s condition.

3. Dr.Sharma , Neurologist has deposed that when he examined patient at Dr.Malhotra’s Hospital, CT Scan report was ready which showed that patient was suffering from Brain Hemorrhage when patient was taken to Dr.Shah. He further deposed that treatment of Brain Hemorrhage is different from that of poisoning.

Negligence4. There is nothing on record to suggest as to what Dr.Shah has done to

ascertain the type of poison was consumed by patient, so that necessary antidote can be given. No Gastric lavage, Emesis, Induced Vomiting which is widely done in cases of suspected poisoning was not done.

5. CT Scan was urgently required, but it is not clear what prevented Dr.Shah from getting CT Scan done.

Decision Dr.Shah guilty of negligence. Treatment given on suspicion

without proper tests amounts to deficiency. But as sole cause of death cannot be attributed to alleged

negligence. Compensation of Rs.15 lacs cannot be awarded. A sum of Rs.2 lacs is reasonable with Rs.2000 towards costs ordered.

Case 4 : Doctor Rashmi Vohra and others Vs Smt. Arunaben D.Kothari and others.

COMPLAINT

1. MR.D.Kothari had a fall, injuring his right arm for which treatment was taken, but it resulted in deformity.

2. After six months he consulted Dr .Rashmi Vora, Orthopaedic surgeon, who advised surgery for deformity correction.

3. The second surgery was carried out by Dr. Rashmi Vohra, Dr. Minaxiben was anesthetist, Dr. pinaben was assisting Dr. Minaxiben, Dr. Shailesh Desai was cardiologist.

4. After certain tests Dr. Shailesh Desai declared the patient fit for operation.

5.Patient was moved to operation theatre on 24-3-90 at 9 A.M.

6. Next entry on record is “Sudden Cardiac arrest” at 9:40 A.M

7. Patient was declared dead at 10 A.M

DECISION OF STATE COMMISSION

1. Doctors held negligent.

2. Compensation of Rs. 4.15 lakhs + Rs. 5,000 as costs to be awarded in the ratio of 30%, 60% and 10% against Dr. Rashmi Vohra, Dr. Minaxiben & Dr. Desai respectively.

APPEAL BY DOCTORSNo case of negligence.Anaesthesia was given as per standard procedure. As soon as she noticed disturbances in waves, she switched off supply of Nitoxide Ether and increased supply of oxygen and informed the surgeon.Surgeon stopped surgery and efforts were made to resuscitate the patient. Services of cardiologist Dr. Desai was sought . But patient died of sudden massive cardiac arrest.

FINDINGS OF NATIONAL COMMISSION

1. Patient was administered Anaesthesia at 9 A.M and died at 9:40 A.M of cardiac arrest.

2. Dr. Gajjar, the assistant doctor, in his re examination states that after 15 minutes of giving Aneasthesia, anesthetist informed that cardiac arrest has occurred.

3. Dr. Vohra in her cross examination states that about 25-30 minutes might have elapsed between commencement of operation and cardiac arrest.

4. Dr.Pinaben anesthetist assisting anaesthetist Dr. Minaxiben, states “cardiac arrest occurred about half an hour after commencement of operation. After going through records I say that it occurred 40 minutes after operation.

5. In view of these three contradicting statements we are not satisfied that cardiac arrest has occurred 40 minutes after operation.

6. The hospital records are silent as to what has happened between 9 A.M i.e. administration of anesthesia and 9:40 A.M when factum of sudden cardiac arrest has been able to explain the cause of cardiac arrest.

7. None of the expert doctors have been able to explain the cause of cardiac arrest.

8. Dr. Vohra the surgeon has stated that “ I cannot explain as to why cardiac arrest took place “. She further adds, “ I cannot say that if supply of oxygen stops at the time of operation, it would result in cardiac arrest. This is very unprofessional statement of a medical practitioner.

9. There is no record of recording blood pressure during surgery, of recording of ECG, heart beat readings are also not recorded. Except for administration of anesthesia nothing is recorded. This inaction is correlated to the prescribed monitoring and also the such crucial 3 to 5 minutes stand between life and death of a patient for non supply of oxygen, this monitoring was of great significance of which no record is available.

10. There is nothing on record to indicate as to when Dr. Minaxiben noticed the disturbances in the waves on the monitor. She was expected to monitor the patient, keep the surgeon informed and also to keep the records. She has done nothing except to record that patient had sudden cardiac arrest at 9:40 A.M.

11. Dr. Minaxiben is completely negligent as rightly held by State Commission.

12. Cardiologist Dr. Shailesh Desai is also negligent as he has noted blood pressure as 150/100 and still declared patient fit for surgery.

DECISION• Decision of State Commission is correct.• Compensation awarded by State Commission is correct.• Appeal by patient’s wife to enhance the compensation is

dismissed.• Appeal by doctors against decision of State

Commission is also dismissed.• Held proper monitoring and record keeping is necessary

and crucial for life of patient. Not to do so can result in death of patient. It is certainly a case of negligence.

All About Our Subject in a Nut Shell

Medicine is about CAN WE?

Ethics is about SHOULD WE?

Law is about WE MUST.