Dr M C Gupta, a doctor turned lawyer, provides medico-legal comments on the MCI (Medical Council of India) guidelines as regards sponsorship of conferences and other events by the pharma industry.
Dr Gupta holds an MD (Medicine) from All India Institute of Medical Sciences (AIIMS), New Delhi; an LLB from Delhi University and an LLM from Kurukshetra University. He has served as a faculty member at AIIMS for 18 years and as professor and dean at the National Institute of Health and Family Welfare. Currently, Dr Gupta is a practising advocate with health and medical law as the area of special interest. He is a member of the Supreme Court Bar Association and Indian Law Institute.
What are the MCI guidelines as regards sponsorship of conferences and other events by the pharma industry?
— Dr V Mahesh, secretary, Family Physicians’ Association, Bangalore
Dr Gupta Responds:
The above notification adds a new regulation to the pre-existing The Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002. This new
1—Regulation No. 6.8.1 (notified vide MCI-211(1)/2009(Ethics)/55667 dated 10th December 2009, regarding the relations between doctors and the pharmaceutical companies) is partly reproduced below:
“6.8 Code of conduct for doctors and professional association of doctors in their relationship with pharmaceutical and allied health sector industry.
6.8.1 In dealing with pharmaceutical and allied health sector industry, a medical practitioner shall follow and adhere to the stipulations given below:
a) Gifts: A medical practitioner shall not receive any gift from any pharmaceutical or allied healthcare industry and their sales people or representatives.
b) Travel facilities: A medical practitioner shall not accept any travel facility inside the country or outside, including rail, air, ship, cruise tickets, paid vacations etc from any pharmaceutical or allied healthcare industry or their representatives for self and family members for vacation or for attending conferences, seminars, workshops, CME programme etc as a delegate.
c) Hospitality: A medical practitioner shall not accept individually any hospitality like hotel accommodation for self and family members under any pretext.
d) Cash or monetary grants: A medical practitioner shall not receive any cash or monetary grants from any pharmaceutical and allied healthcare industry for individual purpose in individual capacity under any pretext. Funding for medical research, study etc can only be received through approved institutions by modalities laid down by law/rules/guidelines adopted by such approved institutions, in a transparent manner. It shall always be fully disclosed.”
2—In simple words, what the above states is that a medical practitioner should not accept any gifts, travel facilities, hospitality, cash or monetary grant, etc for himself or his family. However, it apparently permits some of these being channelled through an association or institution. The importance of the regulation lies in the fact that now the following would become possible:
a—Anybody can complain to the medical council that a doctor is violating regulation 6.8.1 and, acting upon the complaint, the medical council can punish the doctor as per law.
b—A consumer can complain to the consumer court that the service provided by a doctor was deficient or negligent because he prescribed a medicine or appliance or test etc wrongly or unnecessarily in return for favours granted by the pharmaceutical company, even though acceptance of such favours was illegal.
3—The ban is apparently only on travel facilities for vacation or for attending conferences, seminars, workshops, CME programme etc as a delegate. Giving a lecture seems to be excluded.
4—The practice prevalent among physicians of accepting gifts from pharma companies for promotion of their products is against law. It is specifically banned by the MCI Regulations, 2002. Similar ban operates in USA and other countries.
5—The practice prevalent among pharma companies for giving gifts in order to promote their products was not covered under any law so far. Around mid-2012, the Department of Income Tax has issued instructions that expenditure incurred in this connection by the pharma companies would not entitle them for claiming any tax benefits.
6—The question of promotion of pharma products is intimately linked with the practice of promoting brand names of drugs. The Drug Controller General has taken a decision around August-September, 2012 that no permission for brand names would be given in future.
Dr M C Gupta (Former Professor and Dean)
MD (Medicine), LLM
Advocate (Delhi Bar Council No. 857/2001)