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 Hammurabi’s 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].

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 Mathew’s 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 patient’s 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 patient’s 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 patient’s 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.          

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 person’s 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