India: Hospital Waste Management and Principles of Liability:
Efficient Law Minus Enforcement

In the pursuit of preserving the health of the mankind, human brain invented medicine and curative processes including surgery. As medical science progressed, the diseases also increased manifold. Even when man claimed that he eradicated one disease, a new and incurable disease emerged as side or direct effect of the treatment. AIDS is one such disease the man is yet to conquer. Because health is wealth, the health of nature is wealth for the universe and for generations to come. It is everybody’s responsibility to preserve nature for future.

Scientists and religious heads believe it that first the nature was created and then the beings were introduced to live on the nature, which includes the five major components called "Pancha Bhuta"- water, air, earth, fire and sky. Every living being contains these five elements within its body. Like the need of the cleanly maintenance of these elements within body, there is a need to protect them in the nature too. And the process such maintenance should not become the reason for destruction or pollution.

Medicine and surgical operations help in curing diseases. But if we do not learn the methods of disposing the waste generated in the process, the ‘treatment’ will cause the disease. Then the very purpose of the medical inventions and scientific research will be defeated. The Hospital wastes include pathological and radio active wastes. Pathological waste means tissues, organs of body parts, human fetuses, animal carcasses and most blood and body fluids. The radioactive waste (solid, liquid, and gaseous wastes contaminated with radio-nuclides) is generated from invitro or invivo testing.

There is a duty to see that the medical waste will not develop into a monster taking away the fruits of centuries of research and pushing the creatures into disaster. Besides, there will be chemical wastes with discarded solid, liquid and gaseous chemicals from diagnostic chemicals, experimental procedures and disinfecting procedures. Infectious waste include cultures and stocks of infectious agents from laboratories, waste from surgeries, and Autopsy on patients died of infectious diseases, waste from infected patients in isolation wards, and dialysis waste from infected patients. Needles, Syringes, scalpels, blades, broken glass nails and items that could cause a cut or puncture which may become a source of entry of infecting agents are categorized as ‘sharps’. Unused drugs and chemicals, returned from wards constitute pharmaceutical wastes. The average rate of generation of Bio-Med wastes in India varies from 1 kg to 5 kg per bed per day. It is estimated that an average hospital stream contains less than 10 per cent materials that could be considered as potentially infectious agents. The studies reveal that about 2% of a typical hospital waste are pathological waste including body parts etc, which need to be incinerated. Dr. U. V. N. Rao, Resident Medical Officer, Apollo Hospital, Hyderabad says that by implementing good segregation programs, it is possible to reduce this waste stream to less than 8 %. The estimated amount of unregulated infectious waste perday per bed varies between 8000 grams and 11000 grams, which if regulated, would vary between 50 gms and 1500 gms. (Theme paper submitted by Dr. UVN Das, at seminar on Hospital Waste Management, on 16^th &, 17^th December, 2000) It requires disinfecting at regular intervals for storing the infectious wastes. Releasing such hazardous waste from hospitals without treatment will pose a serious threat to health of human beings and environment. It is pollution according to the definition in Section 1 (3) of the U.K. Environment Protection Act, 1990, which explained it as-"The introduction by man into the environment of substances or energy liable to cause hazards to human health, harm to living resources and ecological systems, damage to structure or amenity or interference with legitimate uses of the environment."

It is the duty of every person to protect the environment and prevent its pollution. Domestic laws and international treaties impose this duty on individuals and states. The United Nations has convened an International Conference on the Human Environment at Stockholm in 1972, where a dialogue on protection of environment began. Later United Nations Environment Programme UNEP was established. The concepts of sustainable development and Development without destruction evolved.

The present generation has an obligation to protect their future generations. A man has no right to exploit the ecology to the detriment of to be born. The International Community recognised this responsibility and drafted several instruments reminding the mankind to be kind to the natural world. After the loss of millions of human beings the UN Charter expressed a deep concern for the people yet to be born. (Preamble, Charter of the UNO, 1945).

The Stockholm conference in 1972 explained the imperative goal for mankind as to defend and improve the human environment for present and future generations. Besides war, peace and Development the International Law made a beginning in regulating the environmental issues. Man has both a right to healthy world around and a solemn responsibility to protect and improve the environs for the next generation.

The United Nations General Assembly adopted World Charter for Nature in 1982 (UNGA Resolution 37/7 GAOR, 37^th Session) which explicitly states that the Governments have a duty to pass on their natural heritage to future generations. The WHO regional office for Europe convened a working group of medical professionals, hospital engineers and administrators, which discussed infectious and hazardous waste as a potential risk to public health in 1983.

The World Commission on Environment and Development WCED headed by Giro Harlen Bruntland proposed a set of legal principles for sustainable development and suggested for a global convention for this purpose. (World Commission on Environment and Development, Our Common Future, 1987) For this purpose and for arresting further degradation of the environment and to repair damage already done, the Rio Earth Summit was convened by the UNGA. Maintenance of ecological balance, prevention and control of environmental pollution, preservation of our natural resources, disaster mitigation and sustainable development are the basic factors of the "Earth Charter", which is also called the "Rio Declaration". (Rio Declaration on Environment and Development, 31 ILM 874, 1992)

International treaties, Conventions, Conferences and Protocols resulted in regulatory legislation to protect the environment in several countries for framing policies to protect and improve environment, preventing pollution, punishing environmental crimes, and for compensating the persons affected by breach of protective provisions.

Government of Canada has to agree to pay 350,000 Dollars when US Government raised a dispute over the issue of Trans-frontier air pollution by sulphur-di-oxide fumes originated in Canada. The trial before the arbitration went on for thirteen years.

Even before emergence of environmental laws, polluters were liable under the general principles of tortious liability like nuisance. Blackstone defined common nuisance as a species of the offence against the public order and economic regiment of the State: being either doing of a thing to the annoyance of the Kings’ subjects, or neglecting to it of a thing which the common good requires. (Howk, P.C. 167)

India, which signed the United Nations Conference on the Human Environment held at Stockholm in June 1972 recognised the need of a legislation and passed Environment (Protection) Act, 1986 for protection and improvement of environment and the prevention of hazards to human beings, other living creatures, plants and property. Section 2 (e) defines hazardous substance. It "means any substance or preparation which, by reason of its chemical or physico-chemical properties or handling, is liable to cause harm to human beings, other living creatures, plants, micro-organism, property or the environment". Section 3 gives a general power to the Government of India to take any measure in protecting the environment, which includes imposing punishment and recovering compensation for the victims of pollution.

Section 268 of Indian Penal Code, which has provisions relating to offences affecting the public health, safety, convenience, decency and morals under Chapter XIV, defined public nuisance imposed penal liability. It says that "a person is guilty of public nuisance who does any act or is guilty of an illegal omission which causes any common injury, danger or annoyance to the people in general who dwell or occupy property in the vicinity or must necessarily cause injury, obstruction, danger or annoyance to persons who may have occasion to use any public right. A common nuisance is not excused on the ground that it causes some convenience or advantage".

The High Courts and the Supreme Court of India imposed a duty on individuals and the state to protect the environment holding that the right to life under Article 21 includes right to live in an unpolluted environment also. (T. Damoder Rao v. Special Officer, Municipal Corporation of Hyderabad, AIR 1987 AP 171, per P. A. Choudary, J)

Rule in Rylands v. Fletcher, imposed a strict liability on the persons for the damage caused by escape of a thing collected for extra-ordinary usage. However the rule permitted some defences and exceptions. The scope of this rule and right to life was further extended by the Supreme Court in Shriram Gas Leak case (M.C. Mehta v. Union of India, AIR 1987 SC 965) and Bhopal Gas tragedy hearings (Union Carbide v. Union of India, AIR 1992 SC 248) by creating a new principle of "Absolute Liability". According to this principle, the industry would be absolutely liable for the loss caused by the hazardous and inherently dangerous activity.

A law, which is not in consonance with the fast-developed technological hazards, cannot deal with dangerous consequences of accidents with abnormal and extraordinary prepositions. The law needs to undergo a process of reform and rethinking to race with fast changing technological applications in multinational industrial activities. The judges rightly imposed an absolute and non-delegable duty to ensure that no harm results to any one, on an enterprise engaged in Hazardous or Inherently Dangerous Activity (HOIDA) posing a potential threat to the health and safety of the persons working in the factory and residing in the surrounding areas.

The Supreme Court rightly used the opportunity to create landmark judgment imposing absolute liability for a noble cause of protecting humanity and environment. The principle in Mehta case was reiterated in simple terms in Indian Council for Enviro-Legal Action v. Union of India, AIR 1996 SC 1466. The apex court called it a rule of "Polluter pays", which gained global appreciation and acceptance. ‘Generator is responsible’ is the universal principle holding the health care establishments legally accountable for damage caused by waste management processes.

It should be no answer to the enterprise to say that it had taken all reasonable care and that the harm occurred without any negligence on its part. Because it is not possible to isolate the process of operation from the hazardous preparation of substance or any other related element that caused the harm, it is reasonable and justified to impose strict liability to pay the social cost of the tragedy.

However, it is also the duty of the state to provide for effective remedies against the environmental hazards. The Public Liabilities Insurance Act, 1991 is a step towards fulfilling such an obligation to some extent. This law enables the District Collector to determine immediate relief up to a maximum of Rs 37,500. For larger compensation, the affected person has to seek remedies under other laws or common law developed by the courts. There is another piece of legislation with ambitious plans. The National Environmental Tribunal Act, 1995 creates tribunals to enforce the absolute liability principle.

The Supreme Court directed all hospitals with 50 beds and above to install incinerators or any other effective alternate methods under their administrative control, in 1994 in a public interest writ petition filed Dr. B. L. Wadhera against dumping of Hospital waste from Safdarjang Hospital in the Capital city. The Apex Court also imposed a dead line i.e., 30^th November 1996 for incorporating scientific methods of disposing hazardous medical waste. It also directed that a prior approval from Central Pollution Control Board should be obtained after conforming to the settled standards and also that the CPCB should regularly inspect different hospitals and monitor the garbage disposal processes.

Surprisingly the Government took a long time to act on the directions of the Supreme Court in formulating the guidelines for enforcing the standards in hospital waste disposals and the Biomedical Waste (Management and Handling) Rules under sections 6, 8 and 25 of the Environment (Protection) Act, 1986 was passed in 1998.

According to Rule 3, Bio-Medical waste means any waste, which is generated during the diagnosis, treatment or immunisation of human beings or animals or in research activities pertaining thereto or in the production or testing of biological, and including categories mentioned in Schedule I.

Rule 4 says that It shall be the duty of every occupier of an institution generating bio medical waste which includes a hospital, nursing home, clinic, dispensary, veterinary institution, animal house, pathological laboratory, blood bank by whatever name called to take all steps to ensure that such waste is handled without any adverse effect to human health and the environment. Some standards are prescribed and listed in Schedule V, for treatment and disposal of bio-medical waste. It is mandatory to segregate, pack and label such waste.

Every institute shall have facility to treat bio medical waste. They should possess incinerator, autoclave, and microwave system or ensure a common waste treatment facility. Schedule I suggested measures and methods of treatment and disposal for different categories of biomedical waste. For instance human tissues, organs, body parts, animal tissues, bleeding parts, fluid, blood and experimental animals are to be treated with incineration or deep burial. Schedule III prescribed symbols for Biohazard and Cytotoxic wastes. Schedule V prescribed emission standards and operating standards of waste disposal.

Schedule VI provided a Schedule for arranging waste treatment facilities like incinerator, autoclave, microwave systems. All hospitals and nursing homes in towns with population of 30 lakh population and above, and hospitals and nursing homes with 500 beds and above in towns with population of below 30 lakhs should provide for these facilities by 31^st December 1999. Whereas the hospitals or nursing homes with 200 beds and above but less than 500 beds should provide for such facilities within 31^st December 2000. Hospitals with less than 50 beds and all other institutions were given time up to 31^st December 2002. They are under an obligation to secure authorization and report any accident, for which forms were also provided under Schedule VI.

Biomedical waste is a hazardous material. It is dangerous than a chemical, because a bio-medical waste can cause serious infections and incurable diseases.

Section 8 of Environment (Protection) Act, 1986 imposes a liability to comply with procedural safeguards in disposal of bio-medical waste. The Supreme Court held that it had power to award compensation. It has implicit power issue whatever direction, order or writ to enforce the fundamental right. "The power of the Court is not only injunctive in ambit, that is, preventing infringement of a fundamental right also provides remedial relief against breach of the fundamental right already committed. (Bandhu Mukthi Morchas case, AIR 1984 SC 802). However, Section 15 provides for imposing a penalty of Rs. One lakh and an imprisonment up to five years or both for any violation of the provisions. It also provides for higher penalty in case of continuous violation. But the Environment (Protection) Act, 1986, surprisingly did not provide any measure or liability to pay compensation to the victims of the violations of the provisions.

Public Liability Insurance Act, 1991 made it mandatory for occupiers of hazardous activity to do public liability insurance to provide minimum relief to the victims. It imposes a duty and liability for providing relief specified in schedule for such death, injury or damage. (Section 3). There must be strict implementation of provisions of this enactment.

National Environment Tribunal Act, 1995 provides for strict liability for damages arising out of any accident occurring while handling any hazardous substance and for the establishment of a National Environment Tribunal for effective and expeditious disposal of cases arising from such accident, with a view to giving relief and compensation for damages to persons, property and the environment and for matters connected therewith or incidental thereto.

It is the ethical and social responsibility of health care professionals to control the process of disposal of dangerous wastes of hospital. It is the duty of state, legislators, hospitals and the general public to make sure that environmentally acceptable waste disposal is introduced and implemented effectively. It should be the concern all human beings that there shall be no dumping of pathological waste in the street or front or back yards of hospitals and no floating of bloated infant bodies or amputated legs or wastes from autopsy in the streams amidst dwelling colonies. Though it is the moral duty of medical professionals to see that hazardous wastes are systematically processed and disposed, it is the duty of state to introduce effective legal machinery, redress mechanism and quick process of securing the relief.

The state realized the need to develop and codify the principle of strict civil liability in respect of all accidents in hazardous industries and to create a forum to dispose of cases arising from industrial accidents and disasters providing compensation. The National Environment Tribunal Act, 1995 fulfilled that aim. However, the Tribunal is yet to be constituted. This Act and Public Liability Insurance Act remained non-starters. At present we have good enactment but no political will to enforce, and thus no forum for common citizen to approach for compensation except to knock the doors of High Courts or Supreme Court. Efficient making of law and humane approach in interpretation will have no effect in the absence of effective forum easy procedure and quick disposal. A common man cannot go round the already overburdened civil courts decades together for relief. As the medical expenses and treatment costs are escalating day by day, it is beyond the affordability of millions to tackle the consequences of infections caused by medical waste. They should have a mechanism to secure damages or compensation, which also would work as deterrent for health care professionals to take care of disposal methods. The cost of damages to be paid to a patient suffered by neglected hospital waste should inculcate responsibility on these professionals.

The present system provides only one remedy, that is, to go to ordinary civil courts, which are overburdened with heavy pendency, for payment of damages to compensate the loss caused by the medical wastes under the head of public nuisance. There is no effective tribunal like consumer forum to provide a speedy remedy for the persons infected with disease by medical waste. The Environmental Tribunals have to be constituted. A percentage of hospital profits or part of investments should be set apart for implementing hospital waste management and to pay damages to the persons suffered due to infectious waste.