ABSTRACT
Private medical provision plays an important role in the health care services in India. The quality
of care provided by this sector is a critical issue. Professional organizations such as the Medical
Council of India and local medical associations have remained ineffective in influencing the
behaviour of private medical practitioners. The recent decision to bring private medical practice
under the Consumer Protection Act (COPRA) 1986 is considered an important step towards
regulating the private medical sector. The government believes the COPRA will be effective in
minimizing malpractice and negligent behaviour, but it does have adverse consequences such as
an increase in fees charged by doctors, an increase in the prescription of medicines and
diagnostics, an adverse impact on emergency care, etc. The medical associations have also
argued that the introduction of COPRA is a step towards expensive, daunting and needless
litigation. A number of other concerns have been raised by consumer forums which focus on the
lack of standards for private practice, the uncertainty and risks of medicines, the effectiveness of
the judiciary system, and the responsibility of proving negligence.
Supply factors, depicted by input market conditions and government regulations, and demand
factors, depicted by financing mechanisms and utilization patterns, are likely to determine the
shape and character of private medical practice. The interaction of this complex set of factors
will have considerable implications for the cost, access and quality of services offered by this
sector. Understanding these characteristics from a provider perspective is imperative to influence
the behaviour of providers in this sector.
The findings suggest that growing capital intensity due to cost of location, medical equipment
and technology, and financial sources of capital investments are some unfavourable
environmental factors experienced by private providers. The findings also indicate a high
prevalence of various undesirable practices and low awareness of the objectives of important
legislation among practicing doctors. Lack of awareness of important and relevant legislation
raises serious questions about the implementation of these laws. The paper identifies the strong
need for instituting and implementing an effective continuing medical education programme for
practicing doctors, and linking it with their registration and continuation of their license to
practice. The paper also suggests that cost of health care, access and quality problems will
worsen with the growth of the private sector. The public policy response to check some of the
undesirable consequences of this growth is critical and should focus on strengthening the
existing institutional mechanisms to protect patients, developing and implementing an
appropriate regulatory framework and strengthening the public health care delivery system
The paper also answer questions like how relevant are these concerns? Is the enactment of
COPRA really appropriate to the medical sector? The paper argues that while this development
is a welcomed step, we need to comprehensively look into the various quality concerns. The
effective implementation of COPRA presumes certain conditions, the most important being the
availability of standards. Besides this, greater involvement of professional organizations is
needed to ensure appropriate quality in private practice, since health and medical cases are very
different from other goods and services.
KEY WORDS: Doctors, health care, malpractice, patient, private practitioner
INTRODUCTION
Law helps every man who suffers from an injury due to the acts committed by others, to seek
remedy by means of compensation or punishment to the person committing that act. Since no
man is perfect in this world, it is evident that a person who is skilled and has knowledge over a
particular subject can also commit mistakes during his practice. Such mistakes in the medical
profession may lead to minor injuries or some serious kinds of injuries and sometimes these
kinds of mistakes may even cause death. In such situations there arises a need for a remedy to the
injured people so that justice is upheld and this gave rise to the concept of medical negligence.
Medical malpractice refers to professional negligence by a health care professional or provider in
which treatment provided was substandard, and caused harm, injury or death to a patient. 1
Negligence is the breach of a legal duty of care. Thus legal duty of a person means the duty the
law gives to every person to respect the legal rights of the other. Therefore the legal right of a
person can be defined as the provisions provided by law to protect the interests of its citizen.
The overall Indian healthcare market is worth around US$ 100 billion and is expected to grow to
US$ 280 billion by 2020, a Compound Annual Growth Rate (CAGR) of 22.9 per cent.
Healthcare delivery, which includes hospitals, nursing homes and diagnostics centres, and
pharmaceuticals, constitutes 65 per cent of the overall market. The Healthcare Information
Technology (IT) market which is valued at US$ 1 billion currently is expected to grow 1.5 times
by 2020. India requires 600,000 to 700,000 additional beds over the next five to six years,
indicative of an investment opportunity of US$ 25-30 billion. Given this demand for capital, the
number of transactions in the healthcare space is expected to witness an increase in near future. 2
Private provision of health care is an important constituent of the health care delivery system in
India And its role has increased considerably over time. The growth of the private sector raises a
number of Concerns, most of which stem from reasons of market failure. The State is supposed
to play an important role in regulating this sector but it has so far remained passive. The role of
medical associations and medical councils has been equally minimal. Undesirable practices have
grown considerably, thus affecting the quality of care. The growing dissatisfaction with the
services offered by this sector, and increases in medical negligence cases, have attracted the
attention of the consumer movement in the country. Private medical practice has now been
brought under the Consumer Protection Act (COPRA), 1986.
The application of COPRA to private medical practice is considered an important step in
ensuring that patients receive an appropriate quality of care. The medical associations have not
welcomed this development. However, the legislation does have a number of adverse
consequences, including: increases in fees charged by doctors, increases in the prescription of
medicines and diagnostics, adverse impacts on emergency care. A number of other concerns
have been raised in consumer forums during the hearing of complaints. These concerns relate to
the lack of standards for private practice, difficulty in differentiating between mistaken diagnosis
and negligent behavior, risks and uncertainty in the medical sector, the effectiveness of the
judiciary system, and responsibility to prove negligence.
REASONS THAT BROUGHT MEDICAL NEGLIGENCE UNDER COPRA, 1986
INEFFICIENT STATE REGULATIONS
It is well established that leaving health care to market forces does not lead to an effective and
efficient health care system. This is because a complex set of market distortions and market
imperfections interact with moral hazard problems of market and information asymmetry,
leading the market to be inadequate and to have high costs 3 . It is argued therefore, that the state
has an important role in ensuring the safe and appropriate delivery of health care services from
this sector. However, not many initiatives have been taken by the state to regulate the sector's
services, though the sector has grown significantly. there are only a few examples of regulations
promulgated by the state at local government levels, e.g. the Nursing Home Acts of Delhi and
Bombay. The implementation of these regulations has always been a problem, and most of the
provisions of these legislations are now outdated anyway. Since health is a state subject in India,
a large number of local governments have not implemented similar types of legislation.
LOSS OF INFLUENCE OF MEDICAL ASSOCIATIONS AND COUNCILS IN INDIA
The professional bodies governing the medical profession, such as the Medical Council of India,
are another source of influence on the behavior of private providers. These professional bodies
prescribe the code of conduct which each practicing member is supposed to observe and ensure
that he behaves according to the expectations of these bodies. Generally, it is expected that the
medical profession will work through self- and peer-regulation. However, over time the medical
associations and councils etc., which were expected to play this role, have lost their influence in
regulating the behavior of private providers. Also, a large number of physicians are not active
members of these associations and those who are are often not very concerned about association
guidelines.
As a result, with the growth of this sector the prevalence of certain practices, such as fee-
splitting, over-prescription of medicines and drugs, inadequate sterilization procedures, and
employing untrained personnel, has increased 4 . These undesirable practices are known to
adversely affect the quality of health care. Apart from unnecessary and ineffective care (as a
result of demand inducement), the negligent practices cause immediate harm to the patient,
because of not following minimum standards or lack of desirable skills. This has attracted the
attention of consumer movements in India. Hence, recent legislative reforms in India have
brought medical services provided by the private for-profit sector under the Consumer Protection
Act (COPRA), 1986.
ISSUES RAISED IN CONSUMER FORUMS
Many other concerns have been raised in consumer forums by providers and consumers. This
section examines the four cases of medical negligence filed with the National Commission from
1989-1993.2
The main issues are as follows:
• How important are uncertainties and imperfections in medicine?
• Whose responsibility is it to prove medical negligence?
• Is the judiciary system effective?
UNCERTINITIES AND IMPERFECTIONS IN MEDICINE
Are doctors expected to use the highest level of skill? Is it possible to make a distinction between
mistaken diagnosis, negligent behaviour and cause of death? How important are uncertainties
and imperfections in medical interventions and procedures? These are some of the concerns
raised in various cases filed with the consumer forums. In a leading case, according to the
complainant, an unnecessary operation was performed resulting in the removal of a vital organ.
The complaint filed was that the operation was conducted without proper examination and
diagnosis, and therefore the doctor should be held liable for negligence.
WHOSE RESPONSIBILITY IS IT TO PROVE MEDICAL NEGLIGENCE?
In cases of medical negligence, the onus of proving that the mistake was a result of negligence is
on the complainant. Thus, one problem for patients when trying to prove negligence is access to
experts with their specialist knowledge, and hence, access to specialist information. Doctors are
usually in a more advantageous position, having more information on the case. Under the present
scenario, in most cases private providers do not make the diagnosis information available to their
patients. In many situations where the providers are dispensing their own medicines, patients
have no knowledge of the medicines they consume. Under these circumstances, a patient is not
in a position to put together all the necessary information and documents as evidence, and may
have to incur higher transaction costs if he/she decides to file a negligence case in the consumer
court. The effect of all this is that the patient suffers economically as well as physically.
The responsibility for implementing the code of conduct lies with the medical associations and
councils, but there is no evidence of these institutions assuming any such responsibility for
implementing the code or other regulations. Doubts have been raised about the capacity of these
institutions to implement such guidelines; they do not have the necessary infrastructure and lack
effective mechanisms to handle these issues. No attempt has been made by these institutions to
develop an inventory of standard norms for general and approved practice. Without such
standards, the rulings and judgment in consumer forums will likely be affected by whoever
makes a more forceful argument and amasses more evidence. Judgment of non-technical persons
is influenced by expert opinion; thus the procedure is prone to considerable subjectivity.
Certainly, the COPRA does not ensure implementation of a code of conduct or code of ethics.
Whoever can mobilize expert opinion in his/her favor will have the advantage.
IS THE JUDIACIARY EFFECTIVE ?
There are cases where the complainants have experienced considerable difficulty in interpreting
the law and the position taken by various councils. The complainant in a case, alleged that there
was negligence in the cross-matching of blood and that hospital authorities were also negligent in
completing certain formalities considered necessary in the case. The State Commission disposed
of the complainant by arguing that oral evidence and cross-examination were necessary for the
purpose, and hence the competent forum in this case would be the civil court. The National
Commission reviewed this case and ruled that the State Commission was not justified in
referring the matter to the civil court. 7
The functioning of consumer forums is another area that is considered a major obstacle in
implementing COPRA. At present there are about 500 consumer courts in the country. These are
not adequately staffed and face considerable difficulty due to the lack of infrastructure. The
number of cases filed with consumer forums is growing rapidly and they are unable to settle the
cases within the stipulated time. As a result, the number of pending cases is also increasing; in
total about 200 000 cases are currently pending with these forums. In the medical sector about
50% of the medical cases filed with the CDRC, Gujarat, were pending as of 30 June 1995. Part
of the problem may be related to the complexity of medical cases and the inability to co-opt a
medical person on the panel. It has been argued that in future it will be difficult for consumer
forums to handle the pressure, and consumer redressal forums will soon become clogged and
ineffective.
POLICY IMPLICATIONS
The legislative judgements regarding the applicability of the Consumer Protection Act, 1986, to
the private medical sector are considered an important policy development. This change has been
instrumental in recognizing the patient’s rights in medical services. It establishes that the patient
has a right to question the treatment and procedures in consumer forums if the provider fails to
treat the patient as per the standard medical practice or if the provider has not taken adequate
care in following accepted standards and, therefore, has been negligent in treating the patient.
At the same time there are apprehensions that the future of private practice will see a dramatic
change as a result of the introduction of COPRA. The direct outcome of COPRA is anticipated to
be a growing tendency towards a more defensive medical system among doctors. They are likely
to become extremely cautious in treating their patients as COPRA influences their attitudes to
risk handling. The implications of this Act are considered to include an increase in the
prescription of unnecessary diagnostics and an increase in investigations before treating any
patient, resulting in a higher cost of health care.
Given the various undesirable consequences of COPRA, the successful and effective
implementation of this Act remains an important issue. There are also a number of constraints
under which the Act is being implemented and which may affect its effectiveness for the private
medical sector (Figure 6). Policymakers need to attend to these adverse consequences and
constraints in order for the Act to be implemented effectively.
MAKING COPRA MORE EFFECTIVE
Firstly, one major problem envisaged is the emergence of a defensive medical culture which will
lead to a considerable increase in the cost of care. To overcome this, agencies such as the Indian
Medical Council and Association should look at the charge structure for various procedures.
Already some concerns have been voiced in Parliament about doctors' fees. The thirteenth report
of the upper house of Parliament discusses the arbitrariness in the fee structure of doctors and the
lack of transparency in providing information to patients and in financial matters. The committee
has recommended that each doctor should provide the Medical Council of India with a schedule
of fee charges, and me Council, in turn, should make this information available to the public. It is
recommended that the Medical Council should have responsibility for checking that doctors do
not charge higher fees than those notified. The report also contains recommendations on
developing a ceiling on doctors' charges.
Secondly, the Act, at present, has no provision for punishing people who file false cases. There is
strong apprehension among providers that the number of false cases will increase and that the
legislation will be used for harassing and blackmailing providers. To minimize the misuse of the
legislation, the formation of a screening committee has been suggested to review cases before
they are formally taken before the consumer forums. The screening committee should also
categorize cases in order that only medical negligence cases posing damage or loss to the patient
should be pursued further. In cases where the screening committee finds serious problems with
the quality of care, the matter should be referred to the medical council. To this end, there should
also be a provision for tackling false complaints and the Act should be suitably amended.
Thirdly, most doctors feel that the absence of medical professionals on the panel of councils is a
major drawback of the COPRA. Health sector providers were not involved in enacting COPRA
nor during later developments in the legislation. It is argued that non-medical people sit in
judgement when they are not qualified to make accurate assessments of medical evidence. Thus
the suggestion has been made that medical professionals be given greater representation in order
that a fair view of medical negligence cases can be obtained.
Finally, there should be an orientation programme for newly graduated doctors who want to start
private practice. The adoption of service delivery practices is considerably influenced by the
environment in which the newly graduated doctors start practising. From the beginning they
adopt mere existing practices, most of which are not appropriate. The survey of doctors has
shown that the prevalence of practices such as fee-splitting, over-prescription of drugs and
diagnostics, inadequate standards, etc., is quite high. To combat this, regular continuing
education programmes should be introduced with attendance compulsory. It is well known that a
large number of commercial companies send their executives to management development
programmes to acquire new skills and to learn of developments in their respective fields. In a
large number of companies, promotion policies make it mandatory for executives to attend these
programmes. This need not just apply in the commercial sector.
–By Vedika Kejriwal
School of Law,
Christ University Bangalore.