DR.

RAM MANOHAR LOHIYA NATIONAL LAW

UNIVERSITY

2023-2024

FINAL DRAFT

HEALTH AND MEDICINE LAW

Patients' Consent in India: Analysis, Gaps and Conundrum

Submitted To- Submitted By-

Dr. Prem Kumar Gautam Vanshita Gupta

Assistant Professor (Law) 8th Sem, B.A. LL.B (Hons.)

Enrollment No.- 200101153

 TABLE OF CONTENTS

Patients' Consent in India: Analysis, Gaps and Conundrum ................................. 1

ACKNOWLEDGEMENT .................................................................................... 3

INTRODUCTION ................................................................................................. 4

THE LEGAL BASIS OF CONSENT ................................................................... 5

CONSENT UNDER MEDICAL ETHICS............................................................ 7

JUDICIAL PRECEDENT ..................................................................................... 8

SPECIFIC REGULATIONS GOVERNING CONSENT ..................................... 9

CONSENT IN EMERGENCIES ........................................................................ 10

CONCLUSION ................................................................................................... 13

REFERENCES .................................................................................................... 14
 ACKNOWLEDGEMENT

I would like to use this opportunity to extend my heartiest gratitude to all the people who
have helped me develop this project. First and foremost, I would like to thank Dr. Rajneesh
Kumar Yadav, who has been constantly supporting me, guiding me, and helping me with all
my queries and difficulties regarding this project since its fledgling stage. Without his
enthusiasm, inspiration, and efforts to explain even the toughest of jargon in the most lucid
manner, the successful inception of this project would have been a herculean task. Next, I
would like to thank the librarians of Dr. Madhu Limaye Library for helping me to find the
correct resources for my research and for helping me enrich my knowledge. Finally, I would
like to extend my gratitude to my batch mates and seniors for providing me with some unique
ideas and insights which helped me make this project even better. I know that despite my
sincerest efforts some discrepancies might have crept in, I hope and believe that I would be
pardoned for the same.

Thanking You,

Vanshita Gupta
 INTRODUCTION

Informed consent is the bedrock of ethical medical practice. It is when a medical practitioner
explains a medical treatment, irrespective of whether it is simple, sophisticated, fundamental,
or specific, to a patient, before the patient agrees to it. It is crucial from a liability perspective
as well. The Delhi High Court, in a recent order[1], noted with concern the absence of
informed consent taken from a patient who underwent a hair transplant, which resulted in
complications, leading to death of the said patient. The Court pointed out that hair
transplantation, being an aesthetic surgery, needs to be performed by qualified dermatologists
or trained surgeons with informed consent of the patient. While this matter relates to the
limited aspect of informed consent in a cosmetic surgery setting, the issues raised in the case
may have broader implications.

Informed consent for medical procedures has, for long, been a particularly ambiguous area of
law. Even though there exists a consensus that informed consent is required before
proceeding with any medical treatment, the contours of the same, including the mode of such
consent is not clear.

This project provides a brief regulatory background related to informed consent in India,
judicial pronouncements on the matter, and specific ways of obtaining consent, as laid down
under such regulations. It will also analyze impact of such regulations and judgments in
practical terms, especially with respect to telemedicine and digital health, and situations
where the patient is not in a position to give consent.
 THE LEGAL BASIS OF CONSENT

Consent is perhaps the only principle that runs through all aspects of health care provisions
today. It also represents the legal and ethical expression of the basic right to have one's
autonomy and self-determination. If a medical practitioner attempts to treat a person without
valid consent, then he will be liable under both tort and criminal law. Tort is a civil wrong for
which the aggrieved party may seek compensation from the wrong doer. The consequences
would be payment of compensation (in civil) and imprisonment (in criminal). To commence,
the patient may sue the medical practitioner in tort for trespass to person. Alternatively, the
health professional may be sued for negligence. In certain extreme cases, there is a theoretical
possibility of criminal prosecution for assault or battery. The traditional definition of battery
is an act that directly and either intentionally or negligently causes some physical contact
with another person without that person's consent. If a person has consented to contact
expressedly or by implication, then there is no battery. It is a rare case in which a doctor
would be held liable for criminal breach, unless there is gross disrespect to the patient's
bodily autonomy, for instance, if a patient's organs are taken without his consent.

In tort law, usage of force against any human body, without proper justification, is actionable
irrespective of the quantum of force. If the medical practitioner attempts to treat a patient
without obtaining proper consent, he will be held guilty under tort law. Consent for treatment
may be expressed or implied. The patient entering the consultation chambers by his own
volition may be considered to have given consent for a clinical diagnosis to be carried out.
Consent may be inferred from the general submission by a patient to orders given by a doctor
during clinical diagnosis. This is an excellent example of implied consent. During the clinical
examination, there might arise the need for an intimate examination of the patient, such as a
vaginal examination. For such an examination, the medical practitioner must ideally obtain
another consent by asking the patient's permission orally. Furthermore, if there is a need to
undergo an invasive examination, such as an incision or drawing of samples of body fluids, a
written consent of the patient is ideally required.
Often medical practitioners ask for precise prescriptions for the situations when written
consent is needed. It is interesting to note that what law demands is mere consent and not
written consent and does not prescribe such requirement on a mandatory basis. In fact, the
medical practice itself determines the need for written consent. Ideally, where the patient is
subjected to anesthesia (either local or general) or where the patient is subjected to severe
pain during administration of the treatment, a written consent would be helpful. There is no
mandate that a doctor should always obtain written consent and failure of which would hold
him liable. However, if there is written consent, the medical practitioner would have greater
ease in proving consent in case of litigation. To standardize the practice, the Medical Council
of India (MCI) has laid down guidelines that are issued as regulations in which consent is
required to be taken in writing before performing an operation. The MCI guidelines are
applicable to operations and do not cover other treatments. For other treatments, the
following may be noted as general guidelines:

1. For routine types of treatment, implied consent would suffice

2. For detailed types of treatment, ideally express oral consent may be needed
3. For complex types of treatment, written express consent is required
 CONSENT UNDER MEDICAL ETHICS

The Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002
(Ethics Regulations), govern the duties and responsibilities of registered medical
practitioners (RMP) and lay down the requirement to obtain informed consent from patients.
For instance, before performing an operation, the RMP is required to obtain, in writing,
consent from the patient, or their husband/ wife, or the parent/ guardian (in the case of a
minor). In an operation which may result in sterility, consent of both husband and wife is
needed. Further, no act of invitro fertilization or artificial insemination can be undertaken
without the informed consent of the female patient, her spouse as well as the donor. A patient
is required to provide consent for such procedures in writing, after he/ she is provided with
sufficient information about the purpose, methods, risks, inconveniences, disappointments
and possible risks and hazards, associated with the procedure.

The Telemedicine Practice Guidelines, 2020 (Telemedicine Guidelines), which also form
part of the Ethics Regulations, have a dedicated and detailed section for patient consent. It
lays down that patient consent is necessary for any telemedicine consultation, and that such
consent can be implied or explicit, depending on situation. For instance, the consent is
implied if the patient initiates the telemedicine consultation. However, explicit consent would
be required if the RMP initiates the consultation, and the same may be recorded in any form,
for instance via an email, text or audio/ video message (examples included in the
Telemedicine Guidelines include the phrase “Yes, I consent to avail consultation via
telemedicine” or any such communication in simple words).
 JUDICIAL PRECEDENT

The most extensive guidance on informed consent can be found in judicial precedents on the
matter. Jurisprudence pertaining to medical negligence and the nature of consent required
from patients, before carrying out any medical procedure, has been laid down by the Indian
Supreme Court in a seminal judgment on the subject. Broadly these principles are as follows:

A doctor must give a patient adequate information for him/her to understand the various
aspects of the proposed treatment, as given below, so that he/she can take a call on the
treatment. This would consist of the following:

i. the nature and procedure of the treatment;

ii. its purpose and benefits;

iii. its likely effects and complications;

iv. any alternatives, if available;

v. an outline of the substantial risks; and

vi. adverse consequences of refusing the treatment.

Such ‘adequate information’ need not include remote or theoretical risks, rare complications,
and possible results of a hypothetical negligent surgery. Further, the consent obtained by the
doctor from the patient before commencing a treatment (including surgery) should be real
and valid, which means that: (a) the patient should have the capacity and competence to
consent; (b) consent should be voluntary; and (c) consent should be on the basis of adequate
information, concerning the nature of the treatment procedure, so that he/ she knows what the
consent is for.
 SPECIFIC REGULATIONS GOVERNING CONSENT

Certain regulations also contain specific provisions dealing with informed consent, which are
as follows:

(i) Pre-natal diagnostic procedures cannot be carried out unless all known side and after
effects of such procedures have been explained to the pregnant woman, written consent to
undergo such procedures in the language she understands has been obtained in the prescribed
form, and a copy of the written consent so obtained has been provided to the pregnant
woman;

(ii) No pregnancy of a minor woman, or a woman who, having attained the age of 18
(eighteen) years, is a mentally ill person, can be terminated, without the written consent of
her guardian. Further, no pregnancy can be terminated without the consent of the pregnant
woman;

(iii) In all clinical trials, a freely given, informed, written consent is required to be obtained
from each study subject. The subject’s written consent is required to be obtained, using an
‘Informed Consent Form’ and if the subject is not able to give informed consent, the same
may be obtained from a legally acceptable representative.

Further, an audio-video recording of the informed consent process, in case of vulnerable

subjects in clinical trials of ‘New Chemical Entity’ or ‘New Molecular Entity’, including
procedure of providing information to the subject and his understanding regarding such
consent, is also required be maintained by the investigator. However, in case of clinical trial
of anti-HIV and anti-leprosy drugs, only audio recording of the informed consent process is
required to be maintained.
 CONSENT IN EMERGENCIES

Multiple legislations, regulations, and judicial precedents elaborate upon the concept and
requirement of consent. Despite this, in many cases, the requirement of informed consent for
medical treatments and procedures is still based upon the professional judgment of healthcare
practitioners. Emergency situations, such as those involving accident victims, are an excellent
example of this.

This isn’t to say that there aren’t any legal principles that can help us. In fact, there have been
judicial pronouncements that establish the fundamental norms that must underpin any
practice adopted in this area. Briefly, these are as follows:

(a) Every doctor is professionally obliged to extend his or her services to protect the life of an
injured person, brought to them for treatment, and that ‘no law or state action’ can intervene
to avoid or delay the discharge of this duty. The court further went on to clarify that the
obligation to treat an injured person, being total and absolute, would override any laws of
procedure, which may interfere with the discharge of this obligation;

(b) In case a seriously injured patient is brought in and emergency treatment needs to be
administered, there can be no question of waiting for consent of the patient or from the
person who brought the patient to the hospital. Thus, it was not necessary to wait for consent
before beginning treatment. It was further held that consent is implicit in such emergency
cases when a patient is brought to the hospital for treatment. In fact, a surgeon who fails to
perform an emergency operation must prove that the patient refused to undergo the operation
not only at the initial stage, but also after he or she was informed of the dangerous
consequences of not undergoing the operation;

(c) During emergencies, where a doctor cannot wait for the consent of his patient or where
the patient is not in a fit state of mind to give consent, surgeons cannot say they didn’t
operate on the patient because of lack of consent. When a doctor advances a plea that the
patient did not give consent to a surgery or for a course of treatment advised to him, the
burden is on the doctor to prove that the non-performance of the surgery or the non-
administration of the treatment was on account of the refusal of the patient to give consent
thereto. Even if a patient is fit to give a voluntary response, a surgeon is duty-bound to inform
him of the dangers or the risks involved in going without an operation. The court also
observed that certain sections of the society maybe averse to the idea of a surgery initially,
but may give consent when explained of the consequences of their preferred course of action.
The court also quoted the following passage from ‘Law and Medical Ethics’ by Mason and
McCall Smith:

“As a general rule, medical treatment, even of a minor nature, should not proceed unless the
doctor has first obtained the patient’s consent. This consent may be expressed or it may be
implied, as it is when the patient present himself to the doctor for examination and acquiesces
in the suggested routine. The principle of requiring consent applies in the overwhelming
majority of cases, but there are certain circumstances in which a doctor may be entitled to
proceed without this consent — firstly, when the patient’s balance of mind is disturbed,
secondly, when the patient is incapable of giving consent by reason of unconsciousness; and,
finally, when the patient is a minor”; and

(d) A patient needs to be apprised of the risks involved prior to getting into surgery, or in a
particular course of treatment, before giving consent. When the patient is under general
anaesthesia, the said patient can neither understand the risks involved, nor give consent.

Based on the above, it may be surmised that the law does provide some amount of guidance,
combined with a level of flexibility, to healthcare service providers when it comes to consent
requirement in emergency or accident cases. However, all of this is case specific, and the
personnel who are tasked with dealing with such situations have to unravel the legal
complexities and take decisions in real time.
For instance, what must be done when an accident victim is brought to a hospital, but refuses
treatment (or some parts of the same). Should the doctors accept such refusal, or proceed with
the treatment on the assumption that the victim is not in a fit state of mind. In both cases,
doctors may be called upon to explain the basis of their decisions, including their assessment
of the patient’s state of mind. This is despite the fact that in the Parmanand Katara judgment,
the Supreme Court had called upon lawyers to honour persons in the medical profession and
see to it that they are not called to give evidence so long as it is not necessary.

There are no easy answers when wading into such tricky waters. Each emergency has
different medical implications. The victim may reach the doctor/ hospital alone, with passers-
by, or with acquaintances and family. He may still be in a position to converse and give
consent. Also, he may be conscious, but trauma may cloud his judgment. Amid all this, a
doctor is expected to take decisions, taking into account the interplay of all of the above
factors, with time being of essence, and a possibility of being dragged into courts regardless
of what he decides to do next. And this is only a preliminary procedural issue, with the actual
treatment and application of his expertise yet to commence.

As a mitigating mechanism, at the very least, doctors and hospitals must obtain from patients
their refusal for treatment in writing (and as recommended in the Law Commission of India’s
“201st Report On Emergency Medical Care To Victims Of Accidents And During Emergency
Medical Condition And Women Under Labour”). Further, from a policy perspective, instead
of subjecting medical practitioners to undue scrutiny, they must be granted a privileged legal
standing, especially in relation to aspects of their profession, such as informed consent, which
is still not clearly codified.
 CONCLUSION

As may be gleaned from the above, Indian jurisprudence on the subject of patients’ informed
consent is quite robust. There are general, overarching principles that have been laid down in
the Ethics Regulations as well as judicial pronouncements. Additionally, there are specific
guidelines for certain procedures and activities, such as for medical termination of pregnancy
and conducting clinical trials. However, as witnessed in the Delhi High Court case, issues
related to informed patient consent still keep cropping up. This is because, notwithstanding
the above guidelines, certain minutiae continue to remain unanswered.

Medical treatment cannot be provided by doctors and hospitals without informed consent.
However, subjective discretion of the attending doctor comes up quite often given the
regulatory framework surrounding consent. This must be remedied at the earliest. Clear
procedures must be adopted in each specific fact scenarios. And where the doctors are still
called upon to exercise their judgment, the benefit of doubt must accrue to them alone.

In order to meet the requirements for effective, informed decision making, a physician
must disclose material facts, which are relevant to decision making, including the
patient’s diagnosis, proposed treatment, risks and benefits of the treatment, alternative
treatments along with their risks and benefits, and the risks of refusal. A physician must
answer truthfully about the number of similar procedures or cases performed, and
disclose success rates, and any financial conflict(s) of interest. The physician must advise
patients of all personnel involved in their care and their respective roles, including
residents, students, and equipment representatives. The following mnemonic is useful for
guiding and documenting discussion with the patient: Alternative therapies available,
Benefits of the therapy proposed, Common but not devastating risks, Devastating but
not common risks and Extra considerations specific to the patient in question.
 REFERENCES

• Medical Council of India (Professional Conduct, Etiquette and Ethics) Regulations.

2002.

• New Drugs and Clinical Trials Rules, 2019.

• Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection)
Act, 1994.

• Medical Termination of Pregnancy Act, 1971.

• Indian Penal Code, 1860.
• Criminal Procedure Code, 1973.
• Consent and medical treatment: The legal paradigm in India - PMC (nih.gov)
• Informed Consent in Medical Decision Making In India (researchgate.net)
• Law On Consent And Confidentiality In India (legalserviceindia.com)
• Consent and the Indian medical practitioner : Indian Journal of Anaesthesia
(lww.com)