Jurisprudential thoughts on Medical Law.pdf

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Jurisprudential thoughts on Medical Law

In the common parlance, law denotes to, simply, a consolidation of rules and regulations. However, in modern

times it is a subject for scientific study and it is the high time to have an inter-disciplinary approach, in the

field of law research and law practice, as guidance for better legislative choice and scientific interpretations of

legal concerns.

Initially, departing from the old- traditional notion, the law researchers indentified academic subjects like

economics and politics are some of the social science subjects intertwined with legal studies. Now, we are in

the modern technological era. Now-a-days, in the field of law making, utilities of inter-disciplinary

methodologies have greater significance to frame the legal regulations touching the fields of medicine and

infrastructure development.

There are series of controversies while indentifying the ambit and scope of law and medicine, since theprofessionals form legal as well as medical fields assume that these respective subjects are out of their

professional reaches. The professionals from medical field approach the subject of law, as one of their

concerns, only when the aspects of medical negligence come to hinder their professional practice. Recently

the law researchers invented a branch of law as Medical Law, which has a major role in the coming years

to answer many issues on human beings.

Medical law is the branch of law which concerns, primarily, the prerogatives and responsibilities of medical

professionals and the rights of the patient. It cannot be equate with medical jurisprudence, which is a branch

of medicine, rather than a branch of law. The former refers to the ethical regulations of medical professionals,liabilities and protections while negligent acts are alleged, liabilities under tort and issues when practice turns

to medical mal-practise. The rights of patients, particularly, the right to confidentiality and privacy and right

to health and medical treatment are also some key topics coming under the branch of medical law[1].

On the other hand, Medical jurisprudence[2] or legal medicine is the branch of science and medicine

involving the study and application of scientific and medical knowledge to legal problems. Forensic medicine,

including pathology is a familiar area of medical jurisprudence, known to the legal fraternity, since the

collection and analysis of medical evidence is a major element in the criminal trial. It has a close association

in collecting expert evidences concern to cases of murder (inquest), rape and paternity.

Every progressive society requires a codified medical law enumerating the various legal concerns in the field

of medical practice, manufacturing, supply and sale of medicines and medical devices, procedure and

treatment, rights of patients etc. Even in the era of Hammurabis code[3], there were concerns on medical

malpractices and during those days itself; mandatory regulations were made to regulate the medical practices.

It is usual that the professional ethics are the matters regulated by the apex regulatory bodies of the

professionals and there is little scope for external ethical regulations on the medical profession too. Apart

from statutory code of conducts, self regulation has a greater role in maintaining medical ethics. Self

regulation which is at the heart of medical profession is a privilege and not a right and a profession obtains the

privilege in return for an implicit contract with the society to provide good, competent and accountable

service to the public[4].

When qualifications and registration of medical practitioners are regulated by the statutory prescriptions, it is

always easy to fix and implement the modalities for medical practice and ethical code for medical

practitioners. Modern medicine and traditional/indigenous medicine are two recognized areas among medical

practitioners. There are Medical Council of India[5]and Indian Medicine Central Council[6] to regulate therespective fields of medical practice[7].

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Regulations and control over drugs and pharmaceutical products are another area to be dealt within the scope

of Medical Law. The Drugs and Cosmetic Act, 1940 covers the fields of manufacture, supply and sale of

drugs and pharmaceuticals. When the field of manufacturing of drugs has a close association to the

intellectual property rights, confidentiality and commercial secrecy are the major phenomena while imposing

regulatory framework for drugs and pharmaceuticals. A body under National Drugs Controller General has

been constituted as the apex body to regulate the drugs and pharmaceuticals business in India. In the broader

scope, law has a significant role while deciding the patentability issues of pharmaceuticals products; and even

for it, the courts are eager to test the therapeutic efficacy of such products[8].

Apart from these areas, the advancement of scientific research and of new expertise used in diagnostics,

therapy and treatment opens new fields in terms of accountability. There are legal institutions in the field of

health care to promote and regulate research in the areas of therapy and treatment procedures. Food and

Drugs Agency (USA), National Institute of Clinical Excellence (NICE- UK) are some of such agency. In

India, there is Indian Council of Medical Research (ICMR) and Clinical Trial Registry of India (CTRI) to

supervise clinical research projects of private and institutional medical professionals.

However, unlike FDA and NICE, these agencies have no role at all to account the scope of regulation on

treatment procedures and therapy. In Dr. R A. Mashelkar Committee Report, 2003, there are references

regarding constitution of an Indian Medical Devices Regulatory Authority as a certification agency for

medical devices. Apart from this, the report also refers to constitute a regulatory agency National Drugs

Agency (NDA) to have an overall control over the medical practice, therapy and drugs. Though a Good

Clinical Practice is the goal to be achieved by such a regulatory agency, legislative framework is in the

pre-mature stage, as of now. There are laws regulating transplantation of human organ and tissues, pre-natal

diagnostic procedures, abortion etc and many other allied laws regulating para-medical practices in the field

of Medical Law[9].

Medical Negligence is an area, which judicial adjudications are widespread and imperative. It is the trite law,

referring the field of medical profession, a professional may be held liable for negligence on one of two

findings, either he was not possessed of the requite skill which he professed to have possessed, or, he did not

exercise, his skill with reasonable competence[10]. Negligence is attributable with referring to standard of

expertise and ordinary skill[11]. A patient expects reasonable degree of skills and knowledge from a doctor

and he must exercise a reasonable degree of care, neither the very highest nor the very low degree of care and

competence[12]. The rule in Bolam[13] is the universally accepted standard to assesses medical negligence

that one man clearly is not negligent merely because his conclusion differs from that of other professional

men, nor because he has displayed less skill or knowledge than others would have shown. The true test for

establishing negligence in diagnosis or treatment on the part of a doctor is whether he has been proved to beguilty of such failure as no doctor of ordinary skill would be guilty of if acting with ordinary care. Thus

before proceeding with an investigation on criminal charges of medical negligence, it is always recommends

that investigation agency must obtain an independent and competent medical opinion from another

expert[14]. However for fastening civil liability under compensatory jurisdiction the Mathews Rule is not a

complete formula[15] and such liability can be imposed through expert evidences in the course of

proceedings before civil courts, in appropriate cases[16].

Another major concern of medical law is the protection of patients rights. Proper and timely medical

treatment, access to and supply of affordable medical utilities, right to privacy with respect to clinical medical

records etc are some of such rights, recognised but not yet codified. There are divergent versions on right of

the patient for privacy and confidentiality when it offends right of another for his health[17]. With regard to

transmitted diseases, the prime concern of the State is to maintain public health rather than to protect right to

privacy of an individual.

It is also an explicit rule that the doctor- patient relation is something arising out of obligations which are

matters governed by law of contract and laws on tort[18]. Hence, the patients right to get damages for the

fault committed by his doctor, is always a debatable one[19]. Even the right to consented treatment[20] and

right for an informed treatment[21] are the un-enumerated but judicially evolved classes of patients rights.

The patients and their relatives have reciprocal obligations towards the doctor, but at least in some of theoccasions, alleging medical negligence, the health servants or health institutions are facing physical assault,

which are now made offences under separate law[22], apparently, this also will come under the scope of

medical law.


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Right to health is a fundamental right embodied in the right to life guaranteed under Article 21 of the

Constitution of India. Article 21 guarantees right to life which means a life with normal amenities ensuring

good living which include medical attention, life free from diseases and longevity up to normal expectations.

A healthy body is the very foundation for all human activities. In a welfare State, therefore it is the obligationof the State to ensure the creation and sustaining of conditions congenial to good health. Endorsing to the

above said principles it was held that right to health is a fundamental right[23]. In Paramanand Katara [24], it

was repeatedly held that right to health is an important right guaranteed under Article 21 of the Constitution

and in katara the Court reminded the Medical Practitioners that professional ethics require every medical

practitioner to treat injured for the sake of humanity to save his life and law should not stand in the way of

medical practitioners attending injured persons.

Again in Paschim Banga Khet Mazdoor Samithy v State of West Bengal[25], it was held that a persons right

to get treated is inseparable from the right to life guaranteed under Article 21. However this legal position

does not enable to make a claim that even an unethical and unproved method can be permitted under the

pretext of right to life and it was held that faith healing in public places is unethical and unscientific and

thereby illegal[26].

Obviously, the Medical Law is an un-codified one and requires deliberation and attention, since now it

becomes a significant branch of contemporary jurisprudence. It is inappropriate to allow the precedents and

judicially made laws to govern the field, at least to maintain a little consistency in law and it requires serious

attention.

Dr. Pradeep KODIYATH PATINHARE (LL.M, Ph.D)

Advocate, High Court of Kerala

[1] Annas, G. J., Doctors, Patients, and Lawyers Two Centuries of Health Law,. New England Journal of

Medicine 367 (5): 445450, (2012)

[2] Theodric Romeyn Beck and William Dunloop,. Elements of Medical Jurisprudence, 2ed., Oxford

University Press. (1825)

[3] See the Law Code of Hammurabi. Hammurabi is a Mesopotamian King, ruled Babylonian Empire during

1792-1759 BC, mandates that if a physician make a large incision with the operating knife, and kill him, ... his

hands shall be cut off."

[4] State of Punjab v. Shiv Ram; AIR 2005 SC 3280.

[5] A statutory regulatory body constituted under Section 3 of the Indian Medical Council Act, 1956 with

respect to modern medicine.

[6] A statutory body constituted under Section 3 of the Indian Medicine Central Council Act, 1970 with

respect to Indian medicine, such as Ayurvedha, Siddha and Unani system of medicines.

[7] The Medical Council of India, a statutory professional body, constituted under the provisions of the


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Medical Council Act, 1956 framed the Indian Medical Council (Professional Conduct, Etiquette and Ethics)

Regulations, 2002 in terms of the powered conferred under Section 20A read with Section 33(m) of the Act,

1956

[8] Novartis AG v. Union of India, AIR 2013 SC 1311.

[9] See The Medical Termination of Pregnancy Act, 1971, The Transplantation of Human Organ and Tissues

Act, 1994, The Preconception and Prenatal Diagnostic Techniques (Prohibition of Sex Selection), 1994, The

Mental Health Act, 1987, The Pharmacy Act, 1948, The Nurses and Midwives Act, 1953, The Kerala

Paramedical Council Act, 2007 etc.

[10] Jacob Mathew v. State of Punjab; AIR 2005 SC 3180.

[11] Spring Meadow Hospital v. Harjol Ahluwalia; AIR 1998 SC 1801.

[12] Kusum Sharma v. Batra Hospital, AIR 2010 SC 1050.

[13] Bolam v. Friern Hospital Management Committee;(1957) 2 All ER 118; Also in Hunter v. Hanley (1)

(1955) S.L.T. 213 at p. 217.

[14] Jacob Mathew v. State of Punjab; AIR 2005 SC 3180.

[15] Kishan Rao v. Nikhil Super Speciality Hospital; (2010) 5 SCC 513. See also in Srimannarayanav.Dasari

Santhakumari, 2013 (1) SCALE 606.

[16] Indian Medical Association v. V. P, Shantha; (1995) 6 SCC 651. Also see J.J. Merchant v.ShrinathChathuvedi; (2002) 6 SCC 635.

[17] Mr. X v. Hospital Z; AIR 2003 SCC 664.

[18] State of Kerala v. P.G. Kumari Amma; ILR 2011 (1) Kerala 508.

[19] See Thake v. Maurice; 1986(1) All.ER 497; Gold v. Haringey Health Authority; 1988 QB

481;Allen v. Bloomsbury Health Authority; 1993 (1) All.ER 65, Parkinson v. St. James SUH NHS Trust;

2001(3) All.ER 97. Also see State of Haryana v. Santra; AIR 2000 SC 1888 and Senthil Scan Centrev. Shanthi

Sridharan; 2010 (15) SCC 193.

[20] Samira Kohli v. Dr. Prabha Manchanda; AIR 2008 SC 1385 and Bowater v. Rowley Regis Corporation;

(1944) 1 KB 476. See also Schoendorff vs. Society of New York Hospital; (1914) 211 NY 125 in which it was

held that every human being of adult years and sound mind has a right to determine what should be done with

his body; and a surgeon who performs the operation without his patients consent commits an assault forwhich he is liable in damages.


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[21] Sidaway v. Bethlem Royal Hospital Governors; [1985] 1All ER 643, it was held that doctor has the duty

to disclose information about the potential consequences and risks of proposed medical treatment.

[22] The Law Reforms Committee headed by Justice V.R. Krishna Iyer proposed a separate law for ensuring

the protection of medical practitioners and institutions from physical assault and damages and the Kerala

Legislative Assembly enacted the Kerala Healthcare Service Persons and Healthcare Service Institutions

(Prevention of Violence and Damages to Property) Act, 2012. The patient will also have the right to redressgrievances about the lapses in medical service and the Act provides for taking criminal proceedings against

the doctor in case of medical negligence.

[23] Dr. Vincent v. Union of India; AIR 1987 SC 990,

[24] Paramanand Katara v. Union of India; AIR 1989 SC 2039

[25] AIR 1996 SC 2426

[26] Allahabad High Court in Rajesh Kumar Srivasthava v. A.P. Verma, AIR 2 005 All. 175,

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Jurisprudential thoughts on Medical Law.pdf