Thursday, 11 February 2016

Existing MCI amendment taking ‘associations’ out of ethics regulations is notified

Existing MCI amendment taking ‘associations’ out of ethics regulations is notified

The MCI has finally notified 'new' ethical guidelines. The guidelines elaborate the quantum of punishment for doctors on the basis of the value of favors or freebies received from pharma companies and also include an amendment that makes doctors' associations are beyond the MCI's jurisdiction.

The five-year old guidelines were officially notified in the official gazette on February 1, though they were in existence since 2010. These guidelines were framed by the MCI in March 2010.

The new guidelines amended the Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002 and deleted the words "and professional association of doctors" from section 6.8 of the Code of Medical Ethics Regulation 2002.

The amendments in 2010 were passed by MCI after prior approval of the government a clause required under section 33 of the IMA act. “ 33. Power to make regulations: The Council may, with the previous sanction of the Central Government, make regulations generally to carry out the purposes of this Act, and without prejudice to the generality of this power, such regulations may provide for:-…”

Many doctors are writing in social media that this is a new amendment, but this is not so. It has only been notified now.

As per minute of AGM in 2014 this was rectified, under item 18 “Violation of MCI’s code of ethics by the Indian Academy of Paediatrics (IAP)-Reg.”

The Council noted the following recommendations of the Executive Committee: - “The Executive Committee considered the matter along with opinion of the Law Officer and the Committee accepted the legal opinion. The Committee also considered the relevant aspect that the IMC Act, 1956 is for the constitution of the MCI and maintenance of medical register and for the matters connected therewith. The entire scheme of the Act makes it abundantly clear that it deals with the medical practitioners who get registered with the State Medical Council(s) and whose names are then entered in the Indian Medical Register. The prescription of standards of professional etiquettes and a code of ethics postulated u/s 20A of the Act is also with regard to the conduct of the medical practitioners. It is to be seen that this Act (IMC Act, 1956) has nothing to do with regard to conduct of any association and / or society. The MCI under the Act have no jurisdiction whatsoever regarding any association / society.

The clarity in the scheme of the Act in this regard i.e. to say that the MCI has no jurisdiction whatsoever regarding the conduct of any association / society, does not require anything further in support of this legal position, however, recently, in a case where besides allegation of medical negligence having been made against the treating doctors, grievance was also raised against Max Hospital, Pitampura, Delhi. The Ethics Committee of the Council in its observations / recommendations regarding the allegations of medical negligence had also made adverse observations against the said hospital.

The hospital had challenged the decision of the MCI where the Ethics Committee had made adverse observations against the hospital, by filing a writ petition being W.P.(C) 1334/2013 – Max Hospital, Pitampura Vs. Medical Council of India. On behalf of Max Hospital, it was, inter alia, contended before the Hon’ble Delhi High Court that the MCI regulations do not govern or have any concern with the facilities, infrastructure or running of the Hospitals and that the Ethics Committee of the MCI acting under the Regulations had no jurisdiction to pass any direction or judgment on the infrastructure of any hospital which power rests solely with the concerned State Govt.

The MCI had filed an affidavit in this writ petition filed by MaxHospital before the Hon’ble Delhi High Court. In the MCI affidavit, it had been, inter alia, submitted as under:-

“………..(iii) That the jurisdiction of MCI is limited only to take action against the registered medical professionals under the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 (hereinafter the 'Ethics Regulations') and has no jurisdiction to pass any order affecting rights/interests of any Hospital, therefore the MCI could not have passed and has not passed, any order against the petitioner which can be assailed before this Hon'ble Court in writ
jurisdiction……………”

After consideration of the legal position and the affidavit submitted on behalf of the MCI, the Hon’ble High Court in its judgment dt. 10.01.14, in the above-mentioned writ petition filed by MaxHospital – held as under:- “………7. It is clearly admitted by the Respondent that it has no jurisdiction to pass any order against the Petitioner hospital under the 2002 Regulations. In fact, it is stated that it has not passed any order against the Petitioner hospital. Thus, I need not go into the question whether the adequate infrastructure facilities for appropriate post-operative care were in fact in existence or not in the Petitioner hospital and whether the principles of natural justice had been followed or not while passing the impugned order. Suffice it to say that the observations dated 27.10.2012 made by the Ethics Committee  do reflect upon the infrastructure facilities available in the Petitioner hospital and since it had no jurisdiction to go into the same, the observations were uncalled for and cannot be sustained.

8. Since the MCI had no jurisdiction to go into the infrastructure facilities, I need not also go into the aspect that in the year 2011, the facilities available in the hospital were inspected and were found to be in order.

9. The petition therefore has to succeed. I hereby issue a writ of certiorari quashing the adverse observations passed by the MCI against the Petitioner hospital highlighted in Para 1 above………”
On the plain and simple reading of the provision of the Indian Medical Council Act, 1956, it is apparent that the ambit of statutory provisions relating to professional conduct of registered medical practitioners under the Indian Medical Council Act, 1956 is restricted only to persons registered as medical practitioners with the State Medical Council and whose names are entered into the Indian Medical Register maintained u/s 21 of the Act. Under the scheme of the Act, the complaint of alleged misconduct against a medical practitioner is to be entertained by the concerned State Medical Council. In the event a State Medical Council removes the name of any medical practitioner from the State Medical Register, the MCI becomes obliged to remove the name of the said medical practitioner also from the Indian Medical Register. There is no ambiguity of any kind in the scheme of the Indian Medical Council Act, 1956 that it neither deals with nor provides for any conduct of any association / society and deals only with the conduct of individual registered medical practitioners. There is no other interpretation, which is possible under the Act.

Hence, any reference to “professional association of doctors” in terms of clause 6.8 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 is untenable. Further, independently and additionally the affidavit filed on behalf of the MCI before the Hon’ble Delhi High Court in the writ petition filed by Max Hospital stating the correct legal position and the acceptance thereof by the Hon’ble High Court in its judgment dt. 10.01.14 – leaves no room for any doubt whatsoever regarding the complete absence of jurisdiction of the MCI in relation to conduct of any association / society.

Hence, any action that may have been taken by the MCI opposed to the above-mentioned only possible interpretation regarding the scheme of the Act, against any Association by the MCI – the same would be non-est / nullity for want of authority and jurisdiction. Accordingly, any proceedings that have been initiated by the MCI against any Association by virtue of clause 6.8, being without authority/jurisdiction shall be a nullity, non-existent. As such, any such proceedings stand annulled with immediate effect for want of authority and jurisdiction.

The Council also noted that the Executive Committee of the Council at its meeting held on 17/11/2009 (vide Item No.67) considered the report of the Sub Committee in regard to building a healthy relationship based on self-regulation between doctors and pharmaceutical and allied health sector industries so as to prevent unscrupulous practices by the doctors. Amongst other things the Executive Committee proposed about the “Code of Conduct for Doctors and Professional Association of doctors in their relationship with pharmaceutical and allied health sector industry”. It was proposed therein that in dealing with the pharmaceutical and allied health sector industry a doctor and professional associations of doctors, separate codes of conduct were worked out.

1. Code for doctors shall deal with the issues pertaining to the following:

a) Gifts
b) Travel facilities
c) Hospitality
d) Cash or monetary grants
e) Medical Research
f) Maintaining Profession autonomy
g) Affiliation
h) Endorsement

With reference to relation of professional medical associations/institutions and organizations, it was brought out that ”relation of professional medical associations, institutions & organizations of doctors that are constituted under law with pharmaceutical and health care industries are very important as the office bearers of these are professional doctors and they have the responsibility to uphold the prestige of the profession for which a separate code of conduct needs to be worked out as under:

2. Code for professional associations shall deal with the issues pertaining to the following:

a) Sponsorship
b) Endorsement and
c) Financial Grants

The said recommendation of the Executive Committee were considered by the General Body of the Council held on 18/11/2009 (vide Item No.298) wherein it was approved that the Indian Medical Council (professional conduct, etiquette and ethics) regulations 2002 be amended by incorporation of a clause 6.8 titled “Code of conduct for doctors and professional association of doctors in their relationship with pharmaceutical and allied health sector industry”. However, under the said clause the proposal of the Executive Committee in regard to code of conduct for relation of professional medical associations/institutions/organizations of doctors constituted under law with pharmaceutical and allied health care industries was not approved.

In accordance with the modified recommendations of the General Body of the Council the Govt. of India approved of the said amendment which was notified on 10th December, 2009 titled as “Indian Medical Council (Professional Conduct, Etiquette & Ethics). (Amendment) Regulations 2009.

The said notified amendment to the regulation did not include code of conduct for professional associations of doctors with health care industries.

However, the inadvertent error which seems to have occurred was that the caption of clause 6.8 in the regulation talks of code of conduct for doctors and professional association of doctors. As a matter of fact the word ‘professional association of doctors’ included in the caption of clause 6.8 should have been correspondingly deleted.

Further in terms of the meeting of the Sub Committee held on 18.2.2010 for consideration of review/revision of the Indian Medical Council (Professional Conduct, Etiquette and ethics) Regulation 2002, a Draft of the proposed new Ethics Regulations was made. The same was considered in the meeting of the Executive Committee of the Council held on 4/3/2010 vide Item No.72 wherein it was unanimously approved that the “The title of the Section 6.8 be amended by deleting the words “and Professional Associations” whereby Section 6.8 would read as under:-

“6.8 Code of conduct for doctors in their relationship with pharmaceutical and allied health sector industry”.

The said decision of the Executive Committee was approved by the General Body at its meeting held on 11/3/2010 vide Item No.98. The necessary draft of the amended regulation to the required effect titled “Indian Medical Council (Professional Conduct, Etiquette and Ethics) (Amendment) Regulations, 2010,” was communicated by the Secretary Medical council of India to the Ministry of Health & Family Welfare, Govt. of India, New Delhi for their approval u/s 33 of the IMC Act 1956 vide this office letter dated 11.3.2010 and the letter of approval and authentication was received from the Government of India vide their letter dated 24/5/2010,wherebty it was to be notified in the official gazette of the Govt. of India. However, the Board of Governors (BOG) did not notify the said amendment in terms of the communication from the Govt. of India.

The BOG recommended further amendment to the penalty clause. The amended draft notification was sent to Government of India for approval by the Council on 3/5/2011, in response to which the Govt. of India by their communication dated 19/5/2011 addressed to the Chairman, BOG urged that while sending proposals for amending regulations, apart from the draft of the gazette notification, a comparison in a tabular form indicating the existing regulation in one column and the proposed amendments in the next column, even if the proposal seeks to introduce a new clause or sub clause be furnished to facilitate the examination of the proposal in the Ministry and seeking approval from the Hon’ble Health Minister.

By another communication dated 20/5/2011, the Under Sectary to the Govt. of India informed the Chairman, BOG in response to the communication dated 3/5/2011 to the effect that the proposal be modified in the mode and manner as has been sought vide their communication dated 19/5/2011. A reminder dated 13/6/2011 was sent by the Under Secretary to the Govt. of India to the Chairman BOG to expedite the said matter. However, neither any action nor any communication has been sent by the BOG to the Govt. of India till they laid down their office on 05.11.2013.

It is self-evident that the Board of Governors have modified the amended regulation approved by the Government of India in respect to the penalty clauses only and the said amended proposal is pending consideration. The material reality is that the amendment to the title of 6.8 as approved by the Govt. of India by their letter dated 24/5/2010 deleting the words “and Professional Associations” wherein it has been specifically asked that it be notified in the official gazette on its receipt and has been authenticated as well has remained un-notified till date.

In view of the above, the Council unanimously decided that the amendment to title of section 6.8 of the Indian Medical Council (Professional Conduct Etiquette and Ethics) Regulations, 2002vide notification dated 10/12/2009 and further amended by deletion of the words “and professional association of doctors” duly approved, and authenticated by the Govt. of India vide their communication dated 24/5/2010 be notified forthwith in the official gazette of the Government of India.

1 comment:


  1. The Journal deals with ethical issues in treatment and management of diseases.History of Medicine and Ethics Journal provides a forum for healthcare professionals, theologians, philosophers and sociologists to exchange their ideas from several aspects in relation to Medical ethics and Bioethics

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