How much money is being spent on doctor in conferences? Pharma Companies, Associations may soon have make those Declarations
"UCPMP should make enabling provisions for random/ independent audits of CME/CPD [continuous professional development] and may also work out guidance on expenditure by pharma companies permissible per doctor
New Delhi: The pharma companies and medical associations might need to disclose in the future the money they spend per doctor in conferences, a recent media report by The Print has stated.
Recommendations in this regard were made by a high-level government panel set up to review the Uniform Code of Pharmaceutical Marketing Practices (UCPMP).
Apart from this, the panel has also suggested that the doctors cannot be given brand reminders, in case the value exceeds Rs 1,000 per item. Brand reminders refer to products that are offered for free to doctors by marketing representatives of pharma companies with the names of popular medicinal brands.
Last month, the panel headed by Dr. V.K.Paul, Niti Aayog's member (Health) submitted a detailed report to the Government and mentioned in it that the modified UCPMP guidelines, however, should remain voluntary in nature, although its implementation should be strengthened.
As per the latest media report by The Print, the five-member panel also recommended that amounts received for "permissible research" by doctors from pharma companies should be taxable, while the drugmakers themselves will get tax exemption on the amount spend on research activities.
UCPMP has been in operation since 01.01.2015 to prevent unethical practices by the pharmaceutical companies. his code governs the conduct of pharmaceutical companies in their marketing practices, duly covering the various aspects such as medical representatives, textual and audio-visual promotional materials, samples, gifts, etc. Further, the code establishes relationship with healthcare professionals, wherein the provisions related to travel facilities, hospitality and cash or monetary grants to physicians or their families have been elaborated.
The code also details the mode of operation of the code, responsibilities of the Pharmaceutical Associations in constituting the Ethics Committee for Pharmaceutical Marketing Practices (ECPMP) for handling the complaints and Apex Ethics Committee for Pharmaceutical Marketing Practices (AECPMP) for review, procedure of lodging a complaint, procedure of handling of complaints by the Pharmaceutical Associations and various penalty provisions.
It has been adopted by the all the major associations of pharmaceutical companies and the Department on various instances has reviewed implementation of the code by the Pharmaceuticals associations. The complaints of violation of the voluntary UCPMP by pharma companies, as received by the Department, are forwarded to the concerned pharmaceutical associations for taking necessary action.
Besides UCPMP, there exists sufficient and enforceable legal regime to counter, control and dis-incentivize the unethical marketing practices such as the "Indian Medical Council Professional Conduct, Etiquette and Ethics) Regulations, 2002" under the Indian Medical Council Act, 1956, provisions available under Income Tax Act, Drugs and Cosmetics Act, Prevention of Corruption Act, etc.
Medical Dialogues had earlier reported that last year, the Central Government set up the high-level panel under Dr. VK Paul to hammer out a legal mechanism to address the issue of pharmaceutical companies giving inducements for promoting their drugs and products.
One of the issues that the panel was supposed to review was whether the Uniform Code of Pharmaceutical Marketing Practices be made mandatory for Pharma Companies. Apart from Dr. Paul, the panel also included the secretary of the department of pharmaceuticals S Aparna, Union health secretary Rajesh Bhushan, and Central Board of Direct Taxes (CBDT) chairman Nitin Gupta as members and a joint secretary (policy) from the department of pharmaceuticals as member secretary.
Suggestions made by Government Panel:
The Daily adds that even though the panel has clarified that gifts of any nature to medical professionals by pharma and medical device companies should not be allowed, it has allowed the pharma companies to give brand reminders and free samples to medical professionals. However, it has clarified that the value of brand reminders should not be more than Rs 1000 per item and it should be transparently disclosed through labelling. Further, the panel has suggested that such brand reminders to medical practitioners should be treated as income for doctors.
It has recommended that tax deducted at source (TDS) would be deducted by the pharma company giving these brand reminders, when the value exceeds Rs 20,000 cumulatively in a year. In the existing UCPMP, there is no mention of brand reminders even though companies are permitted to offer free samples to doctors.
In respect of continuing medical education (CME) by associations and pharma companies, the panel has recommended that conduct of such programmes in foreign locations should be prohibited, and engagement of pharma industry with doctors may be allowed both directly and indirectly through a well-defined, transparent, and verifiable set of guidelines.
As per the suggestions made by the panel, trusts or associations and pharmaceutical companies, including those in association with professional bodies and educational or research institutes may organise such conferences, but the organiser will explicitly spell out the procedures followed in the selection of speakers and participants.
The panel mentioned, "UCPMP should make enabling provisions for random/independent audits of CME/CPD [continuous professional development] and may also work out guidance on expenditure by pharma companies permissible per doctor."
It further added that the pharma companies will be required to share the relevant details including the expenses incurred on their websites or on a common website set up by industry associations or government for this purpose.
Regarding research, the panel said that the expenditure on research by the pharma companies is allowable expenditure subject to the provisions of the Income Tax Act, 1961. However, amounts received in the course of permissible research activity from pharma companies will be considered as income in the hands of the doctor and the same will be taxable under relevant provisions of the income tax act.
Besides, the committee has also recommended that the DoP put in place a common portal for reporting and disclosure by industry associations in respect of the implementation of UCPMP to facilitate monitoring of effective implementation.
The panel also mentioned that the ECPMP should be encouraged to engage the services of professional auditors to facilitate better and independent examination of complaints "for arriving at a more informed decision".
Commenting on the recommendations made by the five-member panel, Dr. Paul told The Print that the committee had submitted the report to the government and now it was for the government to consider it. However, he refused to elaborate on the observations and suggestions in the report.
Meanwhile, the secretary of the Department of Pharmaceuticals (DoP) informed that the department was reviewing the report and the first step involved analysing what came under its purview and what required to be done through the National Medical Commission (NMC), the apex medical body in India. "We will then take the next step," he added.
While the pharma associations have welcomed the efforts to review the existing guidelines, the recommendations made by the Government panel has been criticised both by representatives of rights organisations and medical practitioners, although for different reasons.
Plea in Supreme Court:
The Central Government set up the panel following a notice from the Supreme Court, which was considering a case filed by the Federation of Medical & Sales Representatives Association of India (FMRAI) in 2021.
Filing the plea, the association demanded to make UCPMP mandatory and sought directions to the Central Government for giving a statutory basis to the Uniform Code of Pharmaceutical Marketing Practices (Code) and make it effective by making sure monitoring mechanism, transparency, accountability as well as consequences of violations.
Medical Dialogues had earlier reported that the association also urged the Court for laying down the guidelines in order to control and regulate unethical marketing practices by pharmaceutical companies. Alternatively, it also urged the bench or making the existing Code binding with reasonable modifications or additions that get followed by all the authorities and courts under Articles 32, 141, 142 and 144 of the Constitution.
The plea added that the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations of 2002 prescribe a Code of conduct for doctors in their relationship with the pharmaceutical and allied health sector industry, and prohibit acceptance of gifts and entertainment, travel facilities, hospitality, cash or monetary grants by medical practitioners from Pharmaceutical companies.
"This Code is enforceable against doctors, however, does not apply to drug companies, leading to anomalous situations where doctors' licenses are cancelled for misconduct which is actuated, encouraged, aided, and abetted by pharma companies. The pharma companies go scot-free," it added.
The plea said that though termed as 'sales promotion,' in fact, direct or indirect advantages are offered to doctors (as gifts and entertainment, sponsored foreign trips, hospitality, and other benefits) in exchange for an increase in drug sales.
It said that unethical drug promotion can adversely influence doctors' prescription attitudes and harm human health by over-use/ over-prescription of drugs, prescription of higher doses of drugs than necessary, prescription of drugs for a longer period than necessary, prescription of a higher number of drugs than necessary and prescription of an irrational combination of drugs.
It said that pharmaceutical companies use high-pressure promotion practices to lure physicians to prescribe irrational combination drugs to generate massive sales.
NMC RMP (Professional Conduct) Regulations, 2023:
The issue of doctor pharma relationship was also addressed in the National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023. Medical Dialogues had earlier reported that even though these regulations were initially released in August, 2023, they were ultimately put on hold following the protests by several members of the medical fraternity, including the Indian Medical Association (IMA).
These regulations addressed several issues relating to doctors' 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 stated, "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)"
Therefore, these regulations banned 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.
Commercial healthcare establishments, medical device companies, or corporate hospitals under any pretext along with pharmaceutical companies or their representatives were also brought under the purview of NMC regulations.
These rules clearly specified 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. Further, the rules stated that the doctors should not be involved in various events CPD, seminar, workshop, symposia, conferences, etc which are sponsored by pharma and allied health sector.
"Only recognized medical colleges and health institutions or medical Societies accredited or authorized by EMRB/State Medical Councils can offer trainings and credit hours for this purpose," these regulations stated.
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