Wednesday, June 27, 2012

Required: A law to check medical malpractices


Waiting for a law
DR K.M. SHYAMPRASAD

Regulations covering public health should override personal rights and the country cannot wait any more for a good public health law.
S. SUBRAMANIUM 

Ketan Desai, former MCI president, being produced at the Patiala Court in New Delhi in April 2010 after being arrested by the CBI for allegedly demanding Rs.2 crore as bribe from a private medical college to give it official sanction.
The health care industry, including institutions of medical education, hospitals and pharmaceutical businesses, have grown into behemoths that can do considerable harm in the absence of independent and effective regulatory systems. While there are no success stories in the regulation of any kind of industry in India, I will focus on the health care industry as it has the potential for long-term harm to the country’s population. Health care as a commodity or service is not the choice of an individual, like a television set or the menu in a restaurant, but something thrust upon the individual by the health care provider. “Consumers are totally dependent on and at the mercy of external entities to protect their interests,” said the Parliamentary Standing Committee on Health in a recent report.
The Lok Sabha and the Rajya Sabha witnessed recently an unprecedented debate on the manner in which medical education in this country is regulated. The contentious amendment to the Indian Medical Council Act in 2012 to extend the term of the Board of Governors, an ad hoc body created in May 2010 to run the affairs of the Medical Council of India (MCI) until a regular regulatory body is established, was eventually passed. This was not before allegations of corruption and mismanagement were heaped upon the Ministry of Health and Family Welfare.
Allegations of corruption in the MCI were made over several years before the High Court of Delhi, in L.P.A No’.(s) 299 & 301 of 2001 in Union of India versus Dr. Harish Bhalla & Ors. and Dr. Ketan Desai versus Dr. Harish Bhalla & Ors, ordered the removal of Dr Ketan Desai from the presidentship of the MCI as a prima facie case was made out against him. The Central Bureau of Investigation (CBI) was directed to initiate prosecution against him.
No further progress was made in the next seven years. The various agencies that have the responsibility to control corruption and bring to book the wrongdoers failed and possibly connived to reinstate those accused of corruption. Ketan Desai was back as MCI president. Following some curious judicial interventions and government orders notifying his membership of the council, an election was held within the MCI and he was re-elected president. All this happened in a span of a few days. Complaints to the government from people crying foul fell on deaf ears.
In April 2010, the story took another turn with the arrest of Ketan Desai by the CBI on the charge of taking a bribe of Rs.2 crore. Reliable sources suggested that a section of the government was keen to stop this rot in medical education and was willing to go to the extent of bringing in another Act to create a body to regulate the entire Human Resource for Health (HRH). While the idea was laudable, it has not translated into reality.
The story of corruption in medical education, which grows unabated despite the highest powers in the country attempting to curb it, only suggests that big money can be more powerful than political power. This writer made a few calls to the authorities of some private medical colleges some time back enquiring about the process of admissions to undergraduate and postgraduate seats. The answers were straightforward: pay (Rs.35-40 lakh for UG and Rs.60 lakh to Rs.2 crore for PG courses, depending on the subject of specialisation) and take your seat. With 70 per cent of the over 30,000 undergraduate medical seats and over 15,000 PG seats being in the private sector, the kind of black money that is generated through admissions is a formidable power. A country obsessed with “merit” is silent about this practice, which makes medical education the preserve of the very rich. There is no means to evaluate the product of this education, for the providers of education ensure that the candidate is assured of a certificate. The substantive allegations in Parliament against the Health Ministry was that many medical colleges approved by it were substandard and that inspections were rigged. Products of medical institutions that have no scruples are the future health care providers.
The nexus between health care providers and the pharmaceutical business is spreading widely and into remote regions of the country. This means patients consume more drugs, which could be both expensive and unnecessary. For example, a patient with viral fever consults a doctor, who prescribes about five drugs, which will include one or two antibiotics. These antibiotics will be of no use to the patient except in rare circumstances. These drugs will cost the patient anywhere between Rs.500 and Rs.2,000, depending on the choice of the antibiotic.
Unnecessary surgical procedures are conducted. For instance, hysterectomy, which is the most commonly performed surgical procedure in nursing homes, is often done by persuading the patient that she would die otherwise. Such frauds get villagers into debts.
The recently exposed corruption at the drug controller level in the Ministry of Health in approving the entry of drugs into the country suggests that there are new ways of expanding business without benefits to the people.
What is public health?
Public health is what the government and society do collectively to ensure conditions for people to remain healthy. This requires that continuing and emerging threats to the health of the public are countered successfully. These threats include immediate crises such as the H1N1 pandemic and the spread of AIDS; enduring problems such as malaria, tuberculosis, injuries, maternal and childhood illnesses; and growing challenges such as the toxic byproducts of a modern economy, transmitted through air, water, soil and food. These and many other problems make it necessary that the nation’s health is protected through effective, organised, and sustained efforts led by the public sector.
The “essential services” of public health are the monitoring of the community’s health status, diagnosing and investigating health problems; educating people on health; mobilising community partnerships; developing and enforcing health and safety protection; linking people to needed personal health services; creating a competent health workforce; fostering health-enhancing public policies; evaluating the quality and effectiveness of the services; and researching for new insights and innovations.
Public Health versus Curative Medicine
Most scholars who have compared public health with medicine have noted that generally public health focusses on the health of populations, while medicine (curative) focusses on the health of individuals. Medicine and public health have contradictory interests. Consequently, while the art or science of medicine seeks to identify and ameliorate ill health in the individual patient, public health seeks to improve the health of the population.
AFP 

A child suffering from Japanese encephalitis at a hospital in Gorakhpur in Uttar Pradesh on June 11. The death toll due to the viral disease has reportedly risen to 88 in eastern Uttar Pradesh alone this year. It is important to put in place a comprehensive piece of legislation to deal with existing and emerging public health problems.
The focus on populations rather than individual patients is grounded not only in theory but in the methods of scientific inquiry and the services offered by public health. The examples are epidemiology and biostatistics. Epidemiology examines the frequencies and distributions of diseases in the population, while biostatistics provides the database for programme planning.
The contradictions between curative medicine and public health have played a big role in suppressing the public health movement in India. Our national health policy has often pointed out the absence of a public health approach in the country’s health care. The implementers of the health policies have consistently been persons from a curative medicine background. The Director General of Health Services at the Centre or the Directors of Medical Services in the States have not been able to see beyond therapeutic responses to illnesses.
Need for regulation
This unrestrained growth of the health care industry needs to be regulated with political will. We have three pieces of legislation pertaining to health on the anvil, each at a different stage of processing. These are the Clinical Establishments Act, the National Health Bill and the National Commission for Human Resources for Health (NCHRH) Bill. The National Health Bill, which was to cover public health issues, has been in the first draft stage for several years. Without any champion for a Public Health Act in this country, there seems to be little hope for it in the near future. The Clinical Establishment Act, which has been passed by Parliament and signed by the President, is being challenged in two High Courts: it faces strong opposition from the medical fraternity, in particular the Indian Medical Association (IMA), the apex professional body of medical practitioners. The NCHRH Bill has seen many draft revisions and the final version is with the Standing Committee of Parliament on Health and Family Welfare.
The government has shown its ineptitude in enacting the right kind of Bills to safeguard health care standards. The unholy nexus of businesses and health care providers makes matters worse as health care costs push people into indebtedness and even poverty. Patient safety, a prime concern for the World Health Organisation (WHO), is neglected totally. Legislation on health care in India should be drafted by knowledgeable and public-spirited individuals who have the time and inclination to study existing structures in other countries and come up with laws that would protect the common man from the greed of the health care industry.
The objective of legislation aimed at regulating health care should be defined clearly. The objectives of the NCHRH Bill may be defined as:
(1) to assess and evaluate the human resource requirement for the country’s health care and ensure its equitable distribution; (2) to evolve a policy for human resource for health in India with special reference to the rural, tribal and other underserved regions of the country; (3) to develop guidelines on the standards of education and training for health care providers at all levels, including accreditation of institutions; (4) to develop general guidelines on the content of curricula (including continuing education) for health care providers with special reference to integrating Indian systems of health care; (5) to lay down criteria for the registration of health care providers at all levels and oversee their registration, including re-registration after re-certification; and (6) to develop a system for ethical governance of health care and patient safety.
This will require a large-scale needs assessment survey. Since the Bhore Committee of 1948, we have not had any kind of comprehensive assessment of the health needs of the people, nor any evaluation of the country’s health system, including its human resources for health. These are different for the urban and rural areas and also for different regions of the country. Governments, after all these years of experience in governing, have not moved out their fundamental failing in establishing regulatory bodies, which tend to give a “one size fits all” solution through highly centralised authorities who are appointed for their pliability rather than expertise.
The Clinical Establishment Act, for example, has the following contentious clause.
Section 12 (2): The clinical establishment shall undertake to provide, within the staff and facilities available, such medical examination and treatment as may be required to stabilise the emergency medical condition of any individual who comes or is brought to such clinical establishment.
Without compensation for such service, this would be unfair on the medical profession as many peripheral hospitals have emergencies as their main source of income. Certainly a mechanism should have been worked out where the patient is not exploited while service is compensated. The other fear about this Act is that the several new authorities that are created could harass the medical establishments. A balance of powers is certainly required and it is hoped that the State governments, which have ‘health’ as their subject, will come with appropriate Bills (under the Central Act) that will pay attention to issues like the survival of rural medical and surgical units. An appellate authority is also necessary.
Indian health professional organisations such as the IMA and the MCI have failed society by not filling the vacuum in the regulation of health care with an effective self-regulation. The Ethics Committee of the MCI has not removed a single practitioner from its register during the past four years, while during the corresponding period more 200 practitioners were permanently barred from practising in the United Kingdom by the General Medical Council (GMC). “Is it because our doctors are so much better than their British counterparts?” actor Aamir Khan asked MCI chairman Dr. K.K. Talwar in his television show.
The public health situation in India is appalling. The infant mortality rate (IMR), the maternal mortality rate (MMR), and deaths due to tuberculosis and malaria reflect a total lack of appropriate response to the situation. An overarching ‘Public Health Act’ for the country to empower public authorities to enforce laws of public health importance is imperative.
Public Health Law
A public health law is of critical importance to create a climate to ensure health and the right to health for all. Health regulation, which reaches as far back as at least the 17th century, included conditions of travel at sea; isolation and quarantine; inoculation with smallpox pus; sanitary controls on dead fish, animals, and garbage; and quality controls on bread, meat, and drinking water. From the earliest times, public bodies acted in cases of necessity and were prepared to subordinate the freedoms of individuals for the sake of common welfare. During the early 19th century, the sanitary movements emerged in response to epidemics of cholera, smallpox, yellow fever and tuberculosis. Sanitation also changed the way society thought about public responsibility for citizens’ health. Protecting health became a social responsibility.
While the U.K. introduced its Public Health Act more than 200 years ago, such an imperative did not arise in India. While one could analyse the many reasons why such an important law was never introduced in India even after 64 years of Independence, it is now of paramount importance to look at ways and means to bring in a Public Health Act to cover existing public-health problems and emerging health problems without having to wait for Health Ministers to understand health issues and respond in a politically correct manner. Three of the Millennium Development Goals (MDG) – 4, 5 and 6 – relate to public health issues. It is hard to see how a reasonable impact can be made in the reduction of these diseases without a public health response.
There are many grounds on which individuals, businesses and industry would resist public health laws. The argument used most commonly is that they interfere with individual freedom and autonomy. A good example of this was the resistance shown to the introduction of wearing helmets while driving two-wheelers. Industries have resisted regulations on toxic waste disposal and the food industry is uncomfortable with any regulations on food and water standards. Regulations covering public health, based on evidence and science, should override personal rights and the country cannot wait any more for a good public health law.
Dr K.M. Shyamprasad is the Chancellor of Martin Luther Christian University, Shillong, and a Technical Working Group member of the WHO’s World Alliance on Patient Safety.

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