India has approximately 5.2 million medical negligence cases annually. A study for Mumbai showed that medico-legal cases, in courts, against doctors rose from 910 in the period from 1998 and 2006, to 150-200 cases every year. The responsibility to regulate the medical profession lies with the Medical Council of India: a statutory regulator. However, we get little information about whether or when the Medical Council of India (MCI) disciplines doctors. MCI seems to follow a moralistic approach to regulation rather than a legalistic approach.

 

Morals vs Laws

 

A legal system differs from a moral system in three important ways:

 

1. Specificity: Moral standards are usually generic, and rarely provide clear direction for action, in individual situations. In contrast, legal standards strive to be specific and are cognisant of exceptions to the rule. For example, a moral standard may be a generic statement like: Thou shalt not kill. Law, on the other hand, recognises that killing may be justified under many conditions, like defending oneself from a murderous attack, soldiers killing the enemy, an executioner killing the condemned. All of this is codified in various laws justifying killing of another human being in specific circumstances. These have been extensively thought through and developed through legislation and jurisprudence.

 

2. Consequences: Moral statements may prohibit some actions, but rarely have provisions to deal with the consequences of violating them. In contrast, laws focus on consequences of violating proscriptions. For example, a moral principle may be drafted as: Thou shalt not kill. The Indian Penal Code, on the other hand, has no statement prohibiting people from committing murder. It states simply: Whoever commits murder shall be punished with death, or imprisonment for life...

 

3. Enforcement Mechanism: Modern states do not enforce moral principles. For example, there is no enforcement mechanism for people who violate the commandment:"Thou shalt not kill". In contrast, laws are backed by the requisite vast machinery enforcing them. This includes police, judiciary and other supporting laws like law governing trials (Cr.P.C.), evidence, etc.

 

1. Medical Code of Ethics

 

MCI drafted the The Medical Code of Ethics, 2002 ("the Code") to govern medical practitioners. By using the term ‘ethics', it appeals to a moral principle. However, all aspects of the MCI constitute a legal system under the authority of the Parliamentary law (the Medical Council of India Act, 1956). An analysis of a few provisions of the Code shows that while the MCI seems to claim moral authority: it drafts standards in the moral style. Even if it had systems and procedures in place to enforce these standards; the language of the standards would prevent them from being enforced in a legal system. Let us apply these ideas to reviewing three parts of the Code, pertaining to medical records, generic drugs and commissions.

 

Medical Records:

 

Section 1.3.1: of the Code states:nEvery physician shall maintain the medical records (sic) pertaining to his/ her indoor patients for a period of 3 years...... in a standard proforma... attached as Appendix 3. Appendix 3 expects the doctor to mention: Name of the patient, age, sex, address, occupation, date of 1st visit, clinical note (summary) of the case provisional diagnosis, investigations advised, observations, signature in full, and name of treating physician, etc. The record-keeping obligation on physicians is limited to “indoor patients” only. Indoor patients refer to patients in medical establishments (hospitals, nursing homes etc.) for 24 hours or more. This provision suffers from three defects:

 

1. Incomplete coverage: This provision covers a very small proportion of patients that a doctor examines. It completely excludes the vast majority of interactions (such as, chronic case management and procedures) between doctors and patients, i.e. outpatient visits. There is no obligation to keep records or even record prescriptions in any standard manner for those interactions.

 

2. It duplicates work: Medical establishments (hospital, nursing homes, etc.) are already required to keep records for indoor patients. It makes no sense for individual doctors to duplicate the effort. Doctors admit patients in different hospitals and offer consultations, and make clinical rounds in hospitals seeing scores of patients. Maintaining records for each patient/prescription in person with the doctor (not the medical establishment) is irrational.

 

The code does not specify how MCI will identify and enforce against non-compliance. Neither through legal instruments associated with the MCI, nor through any other enactments, is there an enforcement apparatus which involves issues such as accepting complaints, carrying out inspections, requiring the submission of operational data, etc. Section 1.3.4 of the code reads: Efforts shall be made to computerize (sic) medical records for quick retrieval. This is an exhortation and cannot be enforced.

 

Generic names of drugs:

 

This provision is designed to prevent doctors from prescribing brands in return for kickbacks from pharma companies. This problem is so endemic that the government proposes to bring a new law to tackle it. The Code has a provision governing this, in Section 1.5: Every physician should prescribe drugs with generic names legibly and preferably in capital letters, and he/she shall ensure that there is a rational prescription and use of drugs.

 

This obligation states a penalty for violation. The code expects that there should be a rational prescription without any form to verify it. Since there are no standards for how prescriptions have to be written for patients, it is impossible to test compliance. A doctor is not required under the Code to write down the diagnosis. Consequently, it is impossible to verify whether the prescription was rational. There are medical texts and standards in training which specify how a prescription is written. However, the code makes no obligation on doctors to follow them.

 

Commissions

 

Kickbacks from pharma companies to doctors have become a major problem in India. In February 2016, the MCI amended the Code to insert a new provision governing payments received by doctors from pharma and medical technology firms: clause 6.8.1 of the MCI code. This provision is very different from the other provisions in the Code. It clearly leans towards a more legal system rather than a moral system:

 

1. Instead of a general prohibition, commissions have been divided into eight headings: Gifts, travel facilities, hospitality, cash or monetary grants, medical research, maintaining professional autonomy, affiliation, and endorsement.

 

2. Each heading has a definition of what constitutes violation. An example of this is the heading: cash or monetary benefits. While this prohibits receiving money from pharma companies, research grants have been exempted, which could be given to an arm of a hospital.

 

3. For each type of violation there is a specific penalty. For some, it has been graded depending on the magnitude of the violation. For example, if a doctor receives cash above Rs.1000 and up to Rs.5000 he is liable for censure. However, for receiving cash more than Rs.50,000 but up to Rs.100,000, the penalty is removal of the name from the medical register, i.e. barring from practice, for one year.

 

As with the other areas, these rules are ineffectual as the MCI has no system of tracking such gratification or the administrative machinery required to investigate and penalise violators. There are grave problems in India about corruption of doctors in prescribing drugs. We need to do much more in defining and enforcing against these practices. One novel mechanism is found in the US. The government requires doctors and pharma companies to disclose any payments from pharma companies to doctors. There is a website where you can look up your doctor and see what payments he/she has received from the pharmaceutical sector (including medical device manufacturers): Open Payments Data. This has spawned other websites which allow users to analyse the data. Dollars for Docs have used the data to rank doctors and pharma companies.

 

The way forward

 

The regulation of medical profession requires a clear understanding of general principles of regulation. There have been many attempts to reform the medical profession, the latest being the Niti Aayog draft bill. However, legislative provisions which drive a sound regulatory process under MCI are missing. Most drafting of law in India is done by amateurs and lawyers. Drafting laws is, however, not trivial. It requires sound thinking in public administration, law, and economics. There is an entire life cycle of a regulatory system which has to be designed in the law. The typical lawyer, who can support a private person on the legal ramifications of a transaction given a certain section of law, is unable to think about what the law ought to be. Every regulatory system must be animated by a clarity of objective. The parent law must provide the objectives that should drive the government apparatus that it constructs. Too often we draft Parliamentary law which lacks objective. For example the objective of the Payments and Settlement Systems Act is: An Act to provide for the regulation and supervision of payment systems in India...

 

The lack of objective induces a government apparatus that only pursues political objectives and bureaucratic self-interest. The authors of the law need to write down why the law gives powers to regulate: issues such as safety of transactions, safe payment system, competition, innovation and consumer protection. After regulations are made through a sound regulation-making process, powers and systems have to be put in place to check for compliance with those regulations. This requires powers to obtain information, inspect and in some cases investigate. This requires procedural laws to govern inspections and investigations. It also requires thinking about the State capacity in the regulator. Should a regulator make a law where it has no capacity to check compliance? In health, this problem is compounded by the concept of doctor patient confidentiality. As in banking, we need to develop systems by which regulators can check for compliance without breaching the privacy of customers. There is great value in using statistical analysis rather than case by case analysis. For example, if the incidence of caesarean operations in one hospital is substantially more than another hospital serving a similar population, the regulator should ask questions. Even for individual doctors, complaint rates rather than individual complaints may help the regulator identify the problem doctors. Such systems require careful recording and classifying complaints, even when they are not investigated. Every regulatory system needs a quasi-judicial system to penalise or acquit the accused. Penalties should be imposed only after following principles of natural justice and due process. Both patients and the regulator itself should be able to bring complaints and results of investigation before a judicial authority, which is not involved in the investigation. Such an entity should apply some standard of evidence and impose penalties. This requires additional regulations specifying penalties for different types of violations. Penalties have to be proportional to elicit the right response from the regulated. As was known many years ago: Whoever imposes severe punishment becomes repulsive to the people; while he who awards mild punishment becomes contemptible. But whoever imposes punishment as deserved becomes respectable.  -- Chanakya ("Arthashastra", I. "Concerning Discipline", Chapter 4).

 

All these functions require additional provisions governing accountability and transparency expected of the regulator. Regulatory governance in any field requires substantial amount of legal drafting and two levels: the governing parliamentary law and the subordinate regulations made by the regulator. An example of this is the draft Indian Financial Code. While the code covers the entire financial sector including central banking, 135 out of 414 (32%) of the provisions deal with good governance practices in regulators and tribunals, and are a useful first draft for economic regulation in other fields.

 

The authors are researchers at NIPFP.

 

The views expressed in the post are those of the author only. No responsibility for them should be attributed to NIPFP.