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2008 April - Note 2

Liberalising Consent – Supreme Courts preference for ‘Real Consent’ over ‘Informed Consent’ (Samira Kohli v/s Dr. Prabha Manchanda & Anr.) - A. T. M. Rangaramanujam, Senior Advocate, Supreme Court of India

Consent is a major source of dispute between doctors and patients not only in India but all over the world. There are two major school of thoughts which govern the law of consent in medicine. The doctrine of ‘Informed consent’ which shifts the emphasis to the doctor to disclose the necessary information to the patient to secure consent. Under the doctrine of “Real Consent” the doctor must warn his patient of risks inherent in the recommended treatment and the terms of giving such warning must be in accordance with the practice accepted at that time as proper by a responsible body of medical opinion. This is Bolams law or “Real Consent”.

In the present case, Supreme Court has preferred “Real Consent” followed in UK over “Informed Consent” followed in America, in the following terms:
“We are of the view that to nurture the doctor-patient relationship on the basis of trust, the extent and nature of information required to be given by doctors should continue to be governed by the Bolam test rather than the ‘reasonably prudential patient’ test evolved in Canterbury. It is for the doctor to decide, with reference to the condition of the patient, nature of illness, and the prevailing established practices, how much information regarding risks and consequences should be given to the patients, and how they should be couched, having the best interests of the patient. A doctor cannot be held negligent either in regard to diagnosis or treatment or in disclosing the risks involved in a particular surgical procedure or treatment, if the doctor has acted with normal care, in accordance with a recognised practices accepted as proper by a responsible body of medical men skilled in that particular field, even though there may be a body of opinion that takes a contrary view.

The elements of real consent prescribed in the present judgment are:

“(i)  the patient gives it voluntarily without any coercion;
(ii) the patient has the capacity and competence to give consent; and
(iii) the patient has the minimum of adequate level of information about the nature of the procedure to which he is consenting to.”

But when a doctor is specifically questioned by the patient about the risks involved in a particular treatment proposed, the doctor’s duty is to answer truthfully and as fully as the patient requires. Remote risk of damage (referred to as risk at 1 or 2%) need not be disclosed but if the risk of damage is substantial (referred to as 10% risk), it may have to be disclosed.

However, the most important part of this judgment, the ‘heart’ is the reason given by the Court in preferring Real Consent over “Informed Consent.

“In India, majority of citizens requiring medical care and treatment fall below the poverty line. Most of them are illiterate or semi-literate. They cannot comprehend medical terms, concepts, and treatment procedures. They cannot understand the functions of various organs or the effect of removal of such organs. They do not have access to effective but costly diagnostic procedures. Poor patients lying in the corridors of hospitals after admission for want of beds or patients waiting for days on the roadside for an admission or a mere examination, is a common sight. For them, any treatment with reference to rough and ready diagnosis based on their outward symptoms and doctor’s experience or intuition is acceptable and welcome so long as it is free or cheap; and whatever the doctor decides as being in their interest, is usually unquestioningly accepted. They are a passive, ignorant and uninvolved in treatment procedures.”

“There is a need to keep the cost of treatment within affordable limits. Bringing in the American concepts and standards of treatment procedures and disclosure of risks, consequences and choices will inevitably bring in higher cost-structure of American medical care. Patients in India cannot afford them.”

Applying real consent in real life situation would mean that a doctors discretion in disclosing relevant information and risks will be greatly enhanced. Law of Consent will become more refined once the lower courts, especially consumer courts, apply this judgment to different facts and circumstances. As courts start prescribing subjectively the various do’s and don’t’s, the real effect of this judgment will become evident, relieving the doctors from stringent norms of taking patient’s consent. 

This judgment has liberalised as well as crystallized the law of Consent in medicine. It ought to be welcomed by the  medical fraternity as the norms for taking consent have been liberalised, summarised and specifically laid down by the apex court of this country. It must also be welcomed by patients, especially the common man because the Supreme Court has taken note of the high rising cost of health care and the present judgment is a small positive step aimed at meeting this situation.

In 1996, V.P. Shantha’s  case a plea was raised by doctors that if they come within the purview of Consumers Act, courts will be flooded with cases of medical negligence and it will become impossible for them to discharge their professional duties. But the Supreme Court outrightly rejected this argument.

In 2005, in Jacob Mathew’s case, the Supreme Court took note of the rising number of cases in medical negligence and its adverse effect on doctors. Thanks to the various privileges that have been given exclusively to doctors by this judgment, arresting a doctor for medical negligence has become nearly impossible in this country

In 2008, in Samira Kohli’s case (present case) Supreme Court has liberalised the procedure of taking patient’s consent. Hopefully this will make the medical fraternity happy. But the onus of the medical fraternity to self-regulate has simultaneously increased manifold. If they fail, the liberties offered to them may be withdrawn and law may become more stringent. This reverse process has already started in many western countries including England. The Supreme Court, in the present case has aptly warned the doctors “We have however, consciously preferred the ‘real consent’  concept  evolved  in  Bolam  and  Sidaway  in  preference to the ‘reasonably prudent patient test’ in Canterbury, having regard to the ground realities in medical and health-care in India. But if medical practitioners and private hospitals become more and more commercialized, and if there is a corresponding increase in the awareness of patient’s rights among the public, inevitably, a day may come when we may have to move towards Canterbury. But not for the present”.




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