The recent enactment of the “Indian Medical Council (Professional Conduct, Etiquette, and Ethics) (Amendment) Regulations, 2009 Part I” (hereinafter referred to as the ‘said amendment’), completely banning doctors from taking gifts from the pharmaceutical and allied health sector industry was long overdue. The said amendment is in fact more severe than the ones that exist in developed countries. For example, pens and writing pads are permitted in most of the countries, but now the said amendment completely forbids doctors from accepting gifts in any form and that necessarily includes even pens and pads.
The said amendment can be clearly divided into two broad parts. The first part deals with four types of freebies offered by pharmaceutical companies to doctors — gifts, travel facilities, hospitality and cash or monetary grants. The second part seeks to regulate four other aspects of medical practice — medical research, professional autonomy, affiliation and endorsement.
The most contentious part is obviously about gifts. Legally speaking, gift means, “the transfer by one person to another of any existing movable or immovable property made voluntarily and without consideration in money or money’s worth”. Simply stated every object or service that is given without any expectation in return would be a gift. A bare reading of the said amendment makes it clear that doctors are now prohibited from receiving gifts in any form, especially from pharmaceutical companies through their representatives. There are absolutely no exemption. This would mean that even accepting a pen or a free drug sample would be illegal.
Another very important aspect is the direction given to the doctors to maintain professional autonomy. Law is laid down in general terms and hence the amplitude of its application will be very wide. Moreover, this will also result in uncertainty and may prove to be a major irritant for the medical fraternity. More clarification is obviously needed from the law makers on this count.
To understand the overall impact of the said amendment it would be necessary to first know the relevant provisions of the main regulations, that is, the Indian Medical Council (Professional Conduct, Etiquette, and Ethics) Regulations, 2002 (hereinafter referred to as the ‘said regulations’). The present amendment is made in Chapter 6 of the said regulations, which specifies the unethical acts that the doctors are forbidden from aiding, abetting or committing. Chapter 7 stipulates the various acts that constitute professional misconduct and render the doctor liable for disciplinary action. Regulation 7.1, the first section of this chapter, clearly states that violating any part of the said regulations shall constitute professional misconduct. Chapter 8 lays down the punishment and disciplinary action for those doctors who are found guilty of professional misconduct and the extreme action stipulated is a complete lifelong ban from practicing medicine.
On appreciation of the aforesaid provisions it becomes clear that after the said amendment, it is now mandatory for all doctors in India to follow the prescribed norms in toto. Any instance of not following may prove costly.
In this context, it would be relevant to refer to Regulation 8.1 of the said regulations, which goes to the extent of stating that, “Every care should be taken that the code is not violated in letter or spirit”. This means that any act performed merely to cover-up or camouflage an unethical act or misconduct will also attract disciplinary action. My opinion was recently sought by a group of doctors who had formed an association and wanted to know whether they could receive free foreign tours for themselves as members of the said association. A company was ready to sponsor this tour for all the members of their association. Factually, all the members of the association were doctors handpicked by the sponsoring company and the said association was merely a tool to bypass the said amendment. I have given a very clear opinion that any such activity clearly violates the spirit if not the letter of the said amendment, and would therefore be an act of professional misconduct, resulting in legal consequences.
Another interesting, but serious debate that is going around is whether the pharmaceutical companies can give gifts to doctors or not, as they are not disqualified under any law from giving gifts to doctors. There are a few voluntary ethical codes of the pharmaceutical industry, but they do not have any legal sanction. In fact they are more often broken than followed. One does not need to be an expert on law to answer this question. The one who aids and abets in breaking a law is equally at fault. Perhaps, the only way left for the pharmaceutical companies to reach the doctors after the said amendment has come into existence, would be to sponsor the activities of registered and approved medical associations.
The implementation of this new law will certainly be challenging. However, doctors must remember that the latest trend in western countries is to make laws to force pharmaceutical companies to disclose the names of the doctors who have received monetary benefits from them. The Times of India, New Delhi edition, has carried an article on 1.2.2010 reporting that, “Merck and Glaxo have already posted public disclosures about payments made to physicians in the last quarter of 2009”. These disclosures were made in response to a ‘Physicians Payment Sunshine Act,’ which is pending before the US Congress.
If a similar law is made in India, a few years down the line and the names of doctors who have received gifts are publicly disclosed, then the doctor who has received gifts will not only lose face in the society and patients, but will also face disciplinary action, as discussed earlier. Please remember, a few weeks back no one had contemplated that such a strict law, completely banning doctors from taking gifts, would ever be made in India.
Adv. Balaji Srinivasan
24, Lawyer’s Chambers, Supreme Court of India, New Delhi 110 001.