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
8) Industry Relationships should be open to scrutiny.
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
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