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Monthly Archives: January 2010

Firstly, apologies for not blogging regularly. No excuses, but have a new resolution to be more frequently at the keyboard.

The one issue which has forced me out of my cocoon will be debated in the coming months: often in hushed tones in the medical and pharmaceutical circles. That is the newly renewed guidelines to the medical doctors about their relationship with the pharmaceutical industry. The text of the “Indian Medical Council (Professional Conduct, Etiquette and Ethics) (Amendment) Regulations, 2009 – Part-I” (Ref: No.MCI-211(1)/2009(Ethics)/55667) is available in the Indian Gazette, but I first read it here and gratefully acknowledge the author of the blog.

The summary guidelines say:

“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 health care 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 program 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.

e. Medical Research: A medical practitioner may carry out, participate in, work in research projects funded by pharmaceutical and allied healthcare industries. A medical practitioner is obliged to know that the fulfillment of the following items (i) to (vii) will be an imperative for undertaking any research assignment / project funded by industry – for being proper and ethical. Thus, in accepting such a position a medical practitioner shall:-
(i) Ensure that the particular research proposal(s) has the due permission from the competent concerned authorities.
(ii) Ensure that such a research project(s) has the clearance of national/ state / institutional ethics committees / bodies.
(iii) Ensure that it fulfils all the legal requirements prescribed for medical research.
(iv) Ensure that the source and amount of funding is publicly disclosed at the beginning itself.
(v) Ensure that proper care and facilities are provided to human volunteers, if they are necessary for the research project(s).
(vi) Ensure that undue animal experimentations are not done and when these are necessary they are done in a scientific and a humane way.
(vii) Ensure that while accepting such an assignment a medical practitioner shall have the freedom to publish the results of the research in the greater interest of the society by inserting such a clause in the MoU or any other document / agreement for any such assignment.

f. Maintaining Professional Autonomy: In dealing with pharmaceutical and allied healthcare industry a medical practitioner shall always ensure that there shall never be any compromise either with his / her own professional autonomy and / or with the autonomy and freedom of the medical institution.

g. Affiliation: A medical practitioner may work for pharmaceutical and allied healthcare industries in advisory capacities, as consultants, as researchers, as treating doctors or in any other professional capacity. In doing so, a medical practitioner shall always:
(i) Ensure that his professional integrity and freedom are maintained.
(ii) Ensure that patient’s interests are not compromised in any way.
(iii) Ensure that such affiliations are within the law.
(iv) Ensure that such affiliations / employments are fully transparent and disclosed.

h. Endorsement: A medical practitioner shall not endorse any drug or product of the industry publicly. Any study conducted on the efficacy or otherwise of such products shall be presented to and / or through appropriate scientific bodies or published in appropriate scientific journals in a proper way.

It was time that these guidelines were issued and adhered to. Medical profession has too much into disrepute because of the various enticements the drug companies offered and are accepted. The freebies include gifts ranging from pens to motorcars, local and foreign trips to local and international destinations often thinly disguised as academic tours (“conference”), cash and sundry other goodies. A very innovative medical company once offered to start an SIP in my name in return to what they called an ‘exclusive support’ to one of their products.

I have no doubts that any sane person, which includes most doctors, would welcome these restrictions, but I have a couple of points to make:

  1. Along with all the greedy, unscrupulous medical practitioners, genuine academicians have been needlessly restricted by these guidelines. For instance, in my own field of interventional cardiology, the premier academic conferences which propagate new techniques and technologies are held in Europe and the United States. In the absence of any structured training or opportunity to dabble with emerging technologies, this restriction will now condemn us to archaical practices. Of course, since I’m in private practice and because of the pressures of learning new technologies I personally will fund my own training abroad. But with typical conference expenditure between Rs 150,000 to Rs 200,000, how does a typical cardiology faculty member from AIIMS or PGI manage to go to these conferences? True, the government sponsors few faculty members with lots of limit on the expenditure, no of days of attendance, no of times one could go attending conferences, but that kind of scanty attendance would hardly suffice for learning on a large scale. Moreover, governmental funding, already abysmal on research will further fall because huge increases in conference funding.
  2. While the guidelines exhort the doctors to stick to ethical conduct, there doesn’t seem to be any directive towards the pharmaceutical industry. The New Year has started and I am already tired of refusing gifts and overseas conference offers. Representatives of various companies go around asking doctors as to which conference they would like to attend ‘this year’ so that their companies can plan their ‘annual budgets’. Strangely, they don’t seem to acknowledge the existence of these fresh laws to the doctors. So many doctors who are unaware of the laws may accept gifts or conference invitations and may be later on punished.
  3. Despite the MCI formally coming up with the guidelines, the average neighborhood doctor is unlikely to be aware of the existence of the rules and the type of reprimand or punishment they are likely to face in the event of a violation. These laws were reported in some sections of the media. I personally am not aware if the MCI is making any attempt to make doctors aware of these laws. It should. If it has already done it, then there should be more visibility of the awareness program.

Comments are welcome.