Pharma-Doctor Interactions: What has changed in the new Code of Medical Ethics? 10 important takeaways

Written by Dr. Prem Aggarwal Published On 2023-08-16T13:52:42+05:30 | Updated On 16 Aug 2023 5:13 PM IST

Pharma-Doctor Interactions: What has changed in the new Code of Medical Ethics? 10 important takeaways

New Delhi: The new code of conduct is out, and have ordered a major crackdown on the unethical practices of some members of the medical fraternity on taking freebies and benefits from pharmaceuticals, medical devices and allied healthcare companies in lieu of indirect promotion of their products, including prescriptions. While the major feature of the guidelines has been a blanket direction to doctors to prescribe generic names, there has been a separate clause dedicated to engagement with pharma, commercial healthcare establishments, medical device companies, or corporate hospitals.

Section 35 of the National Medical Commission Registered Medical Practitioner RMP (Professional Conduct) Regulations 2023 state

RMPs and their families must not receive any gifts, travel facilities, hospitality, cash or monetary grants, consultancy fee or honorariums, or access to entertainment or recreation from pharmaceutical companies or their representatives, commercial healthcare establishments, medical device companies, or corporate hospitals under any pretext. However, this does not include salaries and benefits that RMPs may receive as employees of these organizations. Also, RMPs should not be involved in any third-party educational activity like CPD, seminar, workshop, symposia, conference, etc., which involves direct or indirect sponsorships from pharmaceutical companies or the allied health sector. RMP should be aware of the conflict-of-interest situations that may arise. The nature of these relationships should be in the public domain such as clinical drug trials and should not be in contravention of any law, rule, or regulation in force. RMP himself or as part of any society, organization, association, trust, etc. make regarding the relationship with the pharmaceutical and allied health sector industry clear and transparent open to scrutiny. (L3)

The clause marks many changes from the earlier Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 (MCI Ethics regulations). Here are 10 important changes in the current regulations

1) No Consultancy/ Honorarium Allowed:

One of the salient differences from the earlier MCI Ethics Regulations 2002 is that the earlier code explicitly allowed doctors to act as consultants or advisors to pharmaceutical companies under certain conditions. Particularly, the erstwhile guidelines stated

MCI 2002: 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 patients interest 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

These explicit conditions have now been removed in the new regulations. On the contrary, the NMC regulations ban doctors from receiving consultancy fee or honorariums from pharma and allied sector. The current allowance of engaging with such organisations has been limited to only employees of such companies who take salary and benefits out of their employment with such companies.

2) Even Medical Device companies, Corporate hospitals and Healthcare establishments, now under NMC's net

The Erstwhile MCI Code of Medical Ethics 2002 through its section 6.8 dealt with the Code of Conduct for doctors and the professional association of doctors in their relationship with "pharmaceutical and allied health sector industry. While the allied health sector industry can have a broad definition, and not specifically mentioned in the earlier MCI regulations; when it comes to freebies, the new NMC regulations explicitly bring under its ambit commercial healthcare establishments, medical device companies, or corporate hospitals under any pretext along with pharmaceutical companies or their representatives.

3) Penalty Now Defined

The earlier Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 categorised under section 6 the various unethical acts to include freebies from pharma companies; however, did not define what would be the level of punishment in case of the violations. The new NMC rules have clearly categorised the freebie clause ( a.k.a. clause 35 of the said regulations) to drawing an L3 penalty, implying that if found guilty, it may lead to suspension of the license to practice for a maximum period of three months.

4) Speakers and Delegates not spared?

There seems to be a growing trend in the industry of doctors participating in pharma-sponsored seminars, conferences and online webinars as Speakers, Chairs etc and receive honorariums. The new NMC rules clearly state that RMPs should not be involved in any third-party educational activity like CPD, seminar, workshop, symposia, conferences, etc., which involves direct or indirect sponsorships from pharmaceutical companies or the allied health sector. This implies that with the new rules, ANY kind of involvement, whether as a speaker or a participant, shall not be allowed. The guidelines call for a stop on blanket involvement under any garb and mark much harsher implications than the earlier 2002 ones that focused on a medical practitioner joining such events as a delegate.

5) Neither Direct Nor Indirect

The regulations state that doctors should not involve in various events CPD, seminar, workshop, symposia, conferences, etc which are sponsored by pharma and allied health sector. The way the clause is framed , seems to add the onus on the practitioner to ensure that there is neither direct nor indirect sponsorship which are commonly executed via third parties.

6) Medical Associations, Conferences to take a Double Hit?

Many Medical Associations depend on sponsorships from pharma, medical device companies as well as corporate hospitals to organise their events. With harsher conditions defined in the new regulations, it will be difficult for such associations to organise their programs. Not only will they have to keep the engagements with the sponsors transparent and open to scrunity, but they would be finding trouble in getting both speakers and participants who will now be prevented from getting involved in any third-party educational activity like CPD, seminar, workshop, symposia, conferences where such sponsorships are involved.

7) Association for Clinical Trials Allowed

Taking cue from the previous regulations, the new NMC code also permits clinical drug trial associations with a clear condition that in such cases the nature of these relationships should be in the public domain, and should not be in contravention of any law, rule, or regulation in force.

8) Industry Relationships should be open to scrutiny.

When it comes to the relationship with pharma and allied health sector, the regulations clearly warn doctors that "RMP should be aware of the conflict-of-interest situations that may arise". It also states that when questioned, such relationships should be transparent and open to scrutiny

"RMP himself or as part of any society, organization, association, trust, etc. make regarding the relationship with the pharmaceutical and allied health sector industry clear and transparent open to scrutiny," the regulations note

9) Procedure for Filing a complaint against Misconduct to be Simplified

The NMC in its regulations, has indicated that the whole process of filing a complaint will be soon made online and both the EMRB/NMC, and the respective state medical council will have a section for the same on their official websites. Complaints can be filed ordinarily within 2 years from the cause of action along with supporting documents and the names and addresses of the witnesses. It also stated the NMC/EMRB/State Medical Council can initiate a suo-moto case against any RMP taking cognizance of gross misconduct.

10) Coming Soon? Guidelines on Interaction with Pharmaceuticals

The National Medical Commission in section 36 of the regulations, grants itself the power to make guidelines, some of which, including Telemedicine Guidelines, CPD guidelines, Code of Ethics, Guidelines on Social Media Conduct of RMPs etc have already been issued by the NMC as a part of the current regulations. The regulations further hint at issuing Guidelines on Interaction with Pharmaceuticals, as and when required and which may be amended from time to time

pharma freebiesNMCnational medical commmissionCode of Medical Ethics

Dr. Prem Aggarwal

Dr Prem Aggarwal, (MD Medicine, DNB Cardiology) is a Cardiologist by profession and also the Co-founder and Chairman of Medical. He focuses on news and perspectives about cardiology, and medicine related developments at Medical Dialogues. He can be reached out at drprem@medicaldialogues.in