Professional Documents
Culture Documents
The main issue concerning public health in the world of medicine is the
medical negligence. The concept of negligence is a tort in civil law. It is an
act or omission that causes harm to an individuals property, reputation or
interests. Tort imposes a duty of care where one party could reasonably
foresee that his or her conduct may cause harm to another. Therefore, in
cases of medical negligence, the claimant has to prove that he or she has
suffered injury or harm because of the negligence of the medical practitioner.
The evolution of the legal concept of medical negligence is a rather recent
development. The tort of negligence itself was founded in the UK with the
case of Donoghue v. Stevenson1, when commercial liability for defective
produce was established. The key ingredient in the establishment of medical
negligence was provided by the Bolam proceedings of 1950. This case
introduced what is called the Bolam test, which has underpinned the UKs
arrangements for more than half a century. The test forms the basis of
defense for medical professionals when they have acted in accordance with
1 [1932] AC 562
In the UK, to deal with clinical negligence in the National Health Scheme
(NHS), the Government created a centrally funded pool of resources to meet
the costs of any claims brought against the NHS. The NHS Litigation
Authority (NHSLA) was set up in 1995 to contest law suits on behalf of the
Secretary of State. Contributions were extracted from NHS Trusts on the
basis of assessments of their risk management procedures. Suits against
general practitioners (GPs) and other primary care professionals are not dealt
with by the NHSLA, but are defended by a number of other medical defense
organizations. The Department of Health, in UK acknowledged the high level
of adverse incidents in NHS hospitals, revealing that 10 per cent of in-patient
admissions resulted in some form of adverse outcome, and five per cent of
the general population report suffering some injury or other adverse effects
of medical care. The factors cited in explanation include underfunding, staff
shortages and overwork and conflicting priorities. However, it is also
accepted that risk management and the avoidance of clinical error has not
received the focus that it deserves in the past.
In India too, lack of alternatives to legal redress had made it very difficult for
the victims of medical accidents or negligence to secure compensations /
apologies from the erring medical practitioner. .This is because the laws of
the land that provided relief in cases of medical negligence under the Law of
Tort and Indian Penal Code had some well documented problems. These
included the following: (i) Inordinate delay in the legal system, which in
medical negligence cases, tends to be greater; (ii) the cost of bringing an
action, is notoriously high in relation to the sums recovered in damages; (iii)
limited access to the courts; (iv) success depends on proof of both
negligence and causation (which can be particularly difficult in cases of
medical negligence). Hence the necessity to provide for an alternate system
which would be easily accessible, speed and cheap, gave birth to the
Consumer Protection Act. This Act was made applicable to the doctors
because there are no provisions in the Indian Medical Council Act, 1956;
15th March is celebrated as World Consumer Rights Day. On this day in 1962,
President J.F. Kennedy declared four basic consumer rights in the special
message to the American Congress, i.e. (a) and other rights were added to it
by IOCU.
In India also, these rights are enshrined in our Consumer Protection Act,
1986. In addition, Indian Penal Code, 1860 sections 52, 80, 81, 83, 88, 90,
91, 92 304-A, 337 and 338 contain the law of medical malpractices in India.
A number of Acts specific to certain aspects of public health is also passed by
the parliament. These are The medical termination of pregnancy Act, The
Pre-Natal Diagnostic Techniques (PNDT) Act, Acts in Disability, Insecticide
Act, Maternity Benefit Act, Narcotic Drugs and Psychotropic Substances Act,
Prevention of Food Adulteration Act, Drugs and Cosmetic Act, Bio-medical
Waste Act 1988, The Pharmacy Act, 1948, The transplantation of Human
Organs Act, Environment Act, Food Safety and Standard regulation Act, Food
Safety and Standards (Prohibition and Restriction on Sales) Regulation Act,
2011 are some of the ad hoc measures taken by the government to protect
the public health.
(REGISTRATION
AND
Main Features
The Bill defines a clinical establishment as:
(a) a hospital,
maternity home,
nursing home,
dispensary, clinic,
sanatorium or an institution by whatever name called that offers services,
facilities with beds requiring diagnosis, treatment or care for illness, injury,
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Applicability
The Bill shall be applicable to all union territories and four states
(Arunachal Pradesh, Himachal Pradesh, Mizoram, and Sikkim). Other
Penalties
2) Transfer of Ownership:
The Bill requires a clinical establishment to apply for fresh registration in
case of transfer of ownership or management. This requirement differs from
the case of transfer of ownership in several other cases, in which the
registering authority is informed and the transfer is recorded in the register.
(For example, if A sells a car to B, the registration number remains the same,
but the ownership is changed by informing the registration office).
Furthermore, in case of a clinical establishment which is registered as a
company and trades on the stock exchanges, the ownership structure
changes every time the stock trades. This provision would imply that a new
registration is required on each such instance.
CLINICAL
ESTABLISHMENTS
REGULATION) ACT, 2010
(REGISTRATION
AND
the District Registration Authorities and the Rules under section 54 of the
act. The National Informatics Centre has developed a web-based software for
the implementation of the CEA 20103. The copies of the Act, Rules are
available on this site.
Firstly it is necessary to note that the framing of the Clinical Establishments
(Registration and Regulation Act, 2010 (CEA 2010) was necessitated since
there has been practically no regulation for private clinical establishments in
the country. This has been due to the opposition by certain sections of the
medical profession and owners of clinical establishments for any kind of
accountability or transparency.
Many state governments were not able to push for enacting legislation
regulating private clinical establishments. In Maharashtra, the Bombay
Medico- Friends- Circle group which took the lead 15 years back by filing a
PIL in the Bombay High court, not much progress has been achieved in the
State. In the above context it was felt that having a central act, would put
pressure on those state governments that do not have any legislation to
adopt a central act and those States to modify their outdated & deficient
existing acts regulating private providers. This seems to have been achieved
to an extent.
SALIENT FEATURES
The salient features of the CEA 2010 are that there would be digital registry
of all types of Clinical Establishments at National, State & District level. All
information provided by the clinical establishment would be available in the
public domain. It would assist government in obtaining data from clinical
establishments required for public health interventions including outbreak
and disaster management among others. The provisional registration would
be through self declaration, without any inspection. Permanent registration
3 http://clinicalestablishments.nic.in/
The Clinical Establishments (Registration and Regulation) Bill, 2010 was introduced in
the Lok Sabha on April 15, 2010 by the Minister of Health and Family Welfare, Shri
Ghulam Nabi Azad. The Bill was passed by the Lok Sabha on May 3, 2010 and is
pending in Rajya Sabha.
The Bill shall be applicable to all union territories and four states (Arunachal Pradesh,
Himachal Pradesh, Mizoram, and Sikkim). Other states may adopt the law by passing a
resolution in the state legislatures.
The Bill seeks to register and regulate clinical establishments. Clinical establishment
is defined as hospitals and clinics and similar facilities that offer treatment for illness in
any recognised system of medicine (allopathy, yoga, naturopathy, ayurveda,
homoeopathy, siddha and unani). It also includes any laboratory which offers
pathological, chemical and other diagnostic services. An establishment can be owned by
the government, a trust, and a single doctor establishment. The Bill does not apply to
any clinical establishment owned or managed by the Armed Forces.
(DGHS) and 22 other members (includes consumer groups and Associations of Indian
Systems of Medicine).
National Register shall be compiled within two years from the date of commencement of
the law and determine the first set of standards for clinical establishments within two
years of setting up the Council.
Every state government shall establish a State/Union Territory Council for clinical
establishments. Members shall include Secretary, Health; Director of Health Services;
elected representatives from state Medical Council, Nursing Council and Pharmacy
Council, and state-level consumer groups or reputed NGOs etc.
The state government shall set up a district registering authority for registering clinical
establishments at district level. Members shall be the District Collector, the District
Health Officer and 3 members with such qualifications to be prescribed by central
government. However, the District Health Officer and Chief Medical Officer shall act as
registering authority for provisional registration.
The functions of the Council include compiling state registers and hearing appeals
against orders of the authority for registration.
The central government shall notify standards for each type of clinical establishment.
The Bill provides for a system of provisional and permanent registration. Provision
registration may be granted for a year. For clinical establishment whose minimum
standards have been notified, provisional registration will only be granted for a specified
time-limit. Permanent registration shall be valid for five years and application for
renewal should be made six months before expiry of registration.
1. Registration/Requirement of Licenses
Rules for the size, contents and correct place for sign boards (IMC
Regulations 2002).
4 Judgment of the Supreme Court of India (SCI) in Sakshi Vs the Union of India and
Others 2004 Supp(2) SCR 723
5 Delhi High Court Judgment in Ms XYZ Vs Shanti Mukund Hospital, Delhi and Punjab
& Haryana High Court Judgment in Jasbir Kaur Vs the state of Punjab CWP No.25449
of 2012
6 Delhi Shops and Establishments Act, 1954
1954).
Authorisation for generation of Bio-Medical Waste and record of
category wise waste generated (BMW Management Rules, 1998);
6. Issue of any medical certificate, notification, document or report, which is
untrue, misleading or improper is a misconduct and punishable offence (IMC
Regulations 2002, Section 197 of Indian Penal Code);
7. Regulations Related to Treatment of Patients
PNDT Act 1994, Conduct of Euthanasia 12 , MTP Act 1971 and IPC
sections 312-315, 318;
Rights of patients;
11 SCI Judgment in Parmanand Katara Vs Union of India, AIR 1989 SC 2039 and The
Delhi State CDRC (Consumer Disputes Redressal Commission) Judgment in the case
of death of NB Sub K L Guliani
12 SCI Judgment in Aruna R Shanbaug Vs Union of India & Others, (2011) 4 SCC 454
Laws applicable to medical negligence Vicarious Liability,
Respondeat Superior, Indian Contract Law, Tort law, Consumer Protection Act,
1986, Indian Penal Code sections14.
8. Drug and Cosmetics Act 1940, Drugs (Control) Act 1950, Narcotic Drugs
and Psychotropic Substances Act 1985, Drugs and Magic remedies
(Objectionable Advertisements) Act, 1954, Pharmacy Act, 1948.
9. Submission of Reports/Returns to Health Authorities
CRITIQUE
There has been opposition and resistance from private providers, owners and
the IMA for any efforts to adopt the CEA 2010 or enact similar legislations.
The Act will lead to license and inspector raj; it is anti-people and curtails
freedom of medical practice, and the penalties are harsh. Another
reservation expressed is that the Act makes it obligatory for clinical
establishments to provide treatment and stabilize patients who are brought
in an emergency medical condition. The standards prescribed are harsh and
would lead to closure of single doctor clinics and small medical
establishments and this will raise the costs of treatment for the general
public.
The apprehensions and reservations voiced by them are unfounded and not
based on clear reading of the provisions of the Act.
Firstly it needs to be stated that the registration of establishments is a
process of applying to the District Registration Authority by providing details
either by post, online or in-person. There is no inspection and the grant of
registration to the establishment is time bound, so that no application
remains unattended. There are provisions for appeal before the State /UT
Council of Clinical Establishments. Regarding penalties the act has
consciously not kept any provision for imprisonment, only monetary
penalties, as the intention is to seek compliance with the provisions rather
than taking punitive action. With regard to Standards being harsh it needs to
be noted that presently there are no standards prescribed. As mentioned
earlier the National Council is presently in the process of categorization of
different types of clinical establishments and determining uniform minimum
IMA along with the Quality Council of India has been engaged by the Union
Ministry of Health and Family Welfare to survey existing standards in clinical
establishments in states where it is applicable. IMA would need to support its
argument that minimum standards would lead to closure of clinical
establishment and increase costs with evidence. The premise of the Act is
that there are few clinical establishments that operate using standards of
care, guidelines and protocols and monitoring of these in the country is
deficient.
IMAs refusal to accept this is contrary to the interests of patient care and
public health. The IMAs reservation that the medical profession is already
governed by number of Acts through multiple regulating bodies is baseless.
The CEA 2010 was passed by the parliament on the request of many state
governments that did not have legislation for clinical establishments. The
provision of the Act, which mandates that every clinic must provide basic
emergency care, is being opposed by the IMA. It is well known that private
hospitals and clinics do not admit accident victims who require critical
emergency care because it can lead to a medico-legal case, or the patient or
their families will be unable to pay for the treatment costs or are uninsured.
This malaise is widely prevalent.
Taking note of this, the Supreme Court of India as long back as 1989 passed
a ruling18 that made it obligatory for all practitioners to provide emergency
medical care. The Act reemphasizes the judgment. It states: clinical
establishment shall undertake to provide within the staff and facilities
available such medical examination and treatment as may be required to
stabilise the emergency medical condition of any individual who comes or is
brought to such clinical establishment.
Further there are concerns being voiced that concerned stakeholders
(including consumer groups) have not been represented in the various
bodies of the CEA 2010. It needs to be noted that the CEA 2010 has 3
institutional mechanisms ie: The National Council, State / UT council and the
District Registration Authority and in each of the bodies there is
18 Parmanand Katara v. Union of India AIR 1989 SC 2039
CONCLUSION
Health and human rights activists have for at least two decades now
demanded a closer scrutiny of medical establishments and health care
systems. This demand has focused on a range of specific concerns mental
health care, primary health care and sex-selective abortions, to randomly
name a few alongside a more general demand for more effective public
health services. There has also been a growing acknowledgement among
practitioners of allopathy of possible conversations between it and other
systems of Indian medicine. At the same time there has been a resistance to
controls by medical professionals across the board, the most telling example
being the case of regulation under the Pre-conception and Pre-Natal
Diagnostic Techniques (Prohibition of Sex Selection) Act (PCPNDT Act) 1994.
This Bill comes as a response to the demand for greater scrutiny in the wake
of spiralling malpractices and gross negligence. In terms of its objects and
reasons, therefore, it is a welcome move. In terms of its operational
elements, however, there are too many gaps, which might well mean that we
have one more legislative response to a public demand that is a mere
action taken report that cannot be implemented. Finally, the question of
self-regulation, transparency and its prospects where clinical establishments
are concerned is one that must be revisited time and again by professional
bodies and individual practitioners. The resistance to the commodification of
health services, and unethical, illegal practices need to come as much from
within as without.
The CEA 2010 is not a perfect act, it has many problems and issues that
have not been covered. However one needs to remember that when
enacting an act there are various pressures from various stakeholders.
Secondly is there a perfect legislation that meets the needs of all interested
stakeholders involved and finally do we keep debating and discussing and
wait for a perfect legislation. It is crucial that the clinical establishments in
the country are accountable and transparent which would greatly improve
the quality of health care in our country.
While the above effort is by all means laudable, yet it is not adequate to deal
with the challenges confronting the field of medicine. A much larger and