March 20, 2010

MCI to amend Medical Ethics Regulations

The lively debate sparked off by the promulgation of Medical Ethics and Etiquettes regulations seems to be bearing fruit.

MCI is all set to amend the Professional Conduct, Etiquette and Ethics regulations it issued in December last year. The apex medical body has recommended some modifications in the regulations in a letter sent to the Ministry of Health & Family Welfare.

In the letter MCI has recommended various degrees of punishment for doctors who accept gifts worth 1000 rupees or more from any pharmaceutical or allied healthcare company.

The punishments range from censure (for accepting gifts valued at between 1,000 and 5,000 rupees) to removal from the Indian or State Medical Register for a period of more than one year (for accepting gifts worth more than 1,00,000 rupees). It merits mention that in making this particular recommendation, MCI has done away with the blanket ban on gifts imposed last month when the regulations were first issued.

The recommendations also address other grey areas including sponsorship of travel and lodging of medical practitioners participating in a conference, the issue of monetary grants and the question of clinical research funding. The monetary limits and the punitive clauses for infringing any of these regulations are similar to those defined for gifts.

Said Dr. Ketan Desai, President MCI, “With these recommendations what we are looking at is strict implementation of the regulations. It seems that there was some ambiguity on a few of the clauses in the regulations. By clearly defining these clauses we have resolved any confusion about the exact nature of these regulations. Once the modified regulations are in place it will be the duty of all the stakeholders to make sure that the regulations are implemented in letter and spirit”.

The modifications come in the wake of popular demand for a review of some of the clauses in the regulations. Ever since the regulations have been issued it has been felt by doctors and Industry alike that some of the clauses in the regulations leave a lot of room for ambiguity. The argument is that if the involved parties are not clear on the regulations, they won’t even realize if and when they have infringed them.

To set the record straight and to facillitate a strict implementation of the guidelines MCI has been mulling an amendment in the regulations for quite sometime now. It is expected that MCI will come out with the amended version of the regulations in a few days.

In this context it is pertinent to mention that a lot of debate has been generated in industry circles on the meaning of the regulations as also on their exact interpretations and possible implications.

Experts have been voicing their opinions on the issue from various platforms and have been emphasizing on the need to dispel doubts and ambiguity surrounding the existent clauses. In a seminar organized last month various shades of opinion were expressed on the need to resolve confusions surrounding the regulations.

Organized by HEAL, a health advocacy and awareness platform, Medical Ethics Conundrum – The Road Ahead saw extensive debates and deliberations on the issue. An expert committee, set up immediately after the conference, was assigned the task of coming up with specific recommendations aimed at facilitating modifications in the regulations, something that would ensure strict implementation.

The expert committee comprising doctors, representatives from OPPI (Organization of Pharmaceutical Producers of India), legal experts, regulators and representatives from the medical devices industry met in Mumbai on the 8th of March and after wide ranging discussions reached a consensus on the final set of recommendations to be sent to MCI.

These recommendations, experts believe, have had a significant impact on the recommendations MCI finally sent to the government. Said Mr. Swadeep Srivastava, Principal Consultant HEAL,” I am grateful to the Medical Council of India and to Dr. Ketan Desai for coming up with recommendations for the modification of the MCI regulations. It brings in a sense of fulfillment for us at HEAL for this brings to fruition the efforts we have been making so far in this direction.

We believe that the modified regulations will be implemented in letter and spirit because these represent a consensus that has been arrived at after extensive deliberations. We are happy that the recommendations made by the expert committee we had formed have played an important role in bringing this about”. As it is, this set of recommendations addresses all the major issues surrounding the regulations. This also represents a consensus that has been arrived at after discussions between all the major stakeholders and therefore ensures their active participation vis – a – vis strict implementation of the regulations.

Link: Original Article

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