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 the
professionals 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 the
respective 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 be
guilty 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 the
occasions, 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 obligation
of 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.Shrinath
Chathuvedi; (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 for
which 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 redress
grievances 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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