Corruption has become the order of the day. To deal with the menace in health industry, MCI comes up with a slew of rules. A critique by Major General Nilendra Kumar

A notification on professional conduct, etiquette and ethics was issued by the Medical Council of India (MCI), a statutory body, during December 2009. The underlying object of the notification is to curb the unhealthy practice of medical professionals accepting gifts, hospitality and travel facilities from the pharmaceutical companies. It is also meant to discourage unethical practices in medical research.

This move by MCI is purported to be under section 33 of the Indian Medical Council Act, 1956. The amendment dated December 10, 2009 in the form of a notification covers acceptance of gifts, hospitality and cash grants. It also seeks to regulate funding of medical research work. However, the change is too early to assess its impact. The amendment has generated considerable discussions amongst the medical profession, pharmaceutical industry and general public. It is undisputed that the medical profession should be governed by ethical considerations. The patient’s welfare should be the sole prerogative and scope for any malpractices be minimised and if possible, totally plugged.

However, a detailed scrutiny of the recent changes to the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 shows the move to be legally infirm and unsustainable on various counts.

To begin with, the amendments seem to have been brought about without any previous public debate and discussion with all stakeholders. Resultantly, a balanced view with suitable inputs from various sections could not be achieved.

The term ‘allied health care’ as used in clause 6.8.1(a) has not been defined leaving the amendments vague and showing lack of clarity. Further, a total ban has been introduced on acceptance of any gifts. What constitutes a gift has been left unsaid. Such a move does not appear to be logical, which is seen as a blanket ban on even gifts of trifling value. Let us assume that it is prohibited to accept a gift exceeding Rs. 1000/- in monetary value. Then would the taking of multiple cheques, say for Rs. 995/- fall outside the ban? If so, it would defeat the very purpose. Moreover, the new move could result in offer of under the table payments in cash.

Health care forms an integral part of the right to life as enshrined as a fundamental right in Article 20 of the Constitution. Protection of life entails living with requisite medical care and in desired health. Such an expectation would be severely impeded, if those qualified and experienced in rendering medical care i.e. medical practitioners are discouraged from interaction, travel, attendance and intercourse with those belonging to the pharmaceutical industry in research, development, testing and evaluation of drugs and equipments.

The change mentions about a ban on acceptance ‘individually’ of hospitality. Logically, therefore, it would not come in the way of a company extending an invitation collectively. A general invitation could be made on the basis of location, speciality, age or hospital basis. To illustrate, take the case of say all ophthalmic surgeons of Delhi with say over 15 years practice. Rather than an invitation to a medical practitioner individually, it could be offered to them collectively. It would then be able to avoid the ban. Thus, the amendment brings about an irrational and baseless classification, which may discourage and derail medical research and studies.

Clause (c) extending a ban on accepting hospitality on self and family members would not cover friends. Thus, it is open to misuse by medical practitioners managing to avail benefit in the name of and through mutual friends. This is yet another instance of improper and defective drafting of the amendments.

Clauses (e) and (f) ordain a medical practitioner not to carry out, participate or work in any research project, funded by a pharmaceutical and allied healthcare industry till it has ‘the due permission from the competent concerned authorities’ and also that it “fulfils all the legal requirements prescribed for medical research” besides having the “clearance of national or state or institutional ethics committees or bodies.” Such a policy places a very heavy burden on a medical practitioner, who has neither the backing of legal qualifications and nor the experience to fulfil such obligations. There could be legal or ethical stipulations set up by the state or union health ministries, environmental, women, child, export or import and countless other issues. How is a medical researcher to keep abreast with conditions, requirements or prohibitions imposed by a vast number of bodies?

Similarly, it is impractical to expect a medical practitioner to ensure that all legal requirements are fulfilled as is mandated by clause (e) (iii). Even if a bonafide satisfaction level has been reached, on whom would lie the onus to demonstrate the same?

Another valid issue is absence of similar restrictions on ayurvaids, hakims, homoeopaths, vets and physiotherapists and the like. Parallel guidelines are not there in nursing ethics. Such a situation would also greatly affect the validity of the instant notification. There is a need for uniform policy and level playing field.

Usually, the legal infractions and violations also stipulate accompanied penalties. However, the recent guidelines offer no clue as to the procedure for inquiry to be held and punishments that can be imposed. Law forbids giving and taking of bribes. Similarly, proposed ethical norms would need to cover both the medicos as well as the drug manufactures. The newly introduced policy concerns medical practitioners and pharmaceutical companies. However, MCI guidelines are silent and in any case lack jurisdiction over the pharmaceutical companies.

Would the way out be the introduction of suitable emphasis by way of industry sponsored continuing medical education? A detailed and extensive examination of the proposed steps followed by an open debate may help in formulation of a proper policy.