THE SUPREME COURT ON INFORMED CONSENT IN INDIA

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The concept and scope of informed consent has been one of the most critical and highly debated issues in medical treatment in India and elsewhere. According to the Supreme Court in Samira Kohli vs. Dr. Prabha Manchanda and Another (2008) 2 SCC 1, consent in the context of a doctor-patient relationship, has been defined as the grant of permission by a patient for an act to be carried out by a doctor, such as a diagnostic, surgical or therapeutic procedure.

The Medical Council of India (MCI) has laid down in the Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002 that a physician, before performing an operation, should obtain in writing the consent from the husband or wife, parent or guardian in the case of minor, or the patient himself as the case may be. Otherwise, it shall constitute professional misconduct on the part of the physician rendering him/her liable for disciplinary action by MCI.

The Supreme Court in Samira Kohli (supra) has discussed about the following essentials elements of informed consent:

A doctor must give a patient adequate information for him to understand the various aspects of the proposed treatment as given below so that he can make a balanced judgment as to whether to submit himself to the particular treatment or not:

the nature and procedure of the treatment;

its purpose and benefits;

its likely effects and any complications which may arise;

any alternatives if available;

an outline of the substantial risks; and

adverse consequences of refusing treatment.

Such adequate information need not include remote 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: i) the patient should have the capacity and competence to consent; ii) his consent should be voluntary; and iii) his consent should be on the basis of adequate information concerning the nature of the treatment procedure, so that he knows what is consenting to.

Also, even if a doctor deems necessary any additional procedure or treatment for a patient, then he/she cannot perform such procedure without the consent of the patient unless the unauthorized additional or further procedure is necessary in order to save the life or preserve the health of the patient and it would be unreasonable to delay the further procedure until the patient regains consciousness and takes a decision. The Supreme Court in another case of Martin F.D’ Souza v. Mohd. Ishfaq, (2009) 3 SCC 1 has also laid down that a doctor should not experiment unless necessary and even then he should ordinarily get a written consent from the patient.

Further, the consent given for a specific treatment procedure will not be considered valid for conducting some other treatment procedure. Moreover, the correctness or appropriateness of the treatment procedure, does not make the treatment legal, in the absence of consent for the treatment. This principle has been reiterated by the Supreme Court in Nizam’s Institute of Medical Sciences vs. Prasanth S. Dhananka & Ors (2009) 6 SCC 1.

The Supreme Court in Samira Kohli (supra) has held that performance of such a surgery was an unauthorized invasion and interference with the patient’s body which amounted to a tortious act of assault and battery and therefore, a deficiency in service under the Consumer Protection Act 1986. The Courts in India have in various other cases also held doctors liable for performing medical treatments and surgeries, etc without obtaining informed consent from the patient.

Harini Daliparthy

Senior Legal Associate