New Delhi: With the Government of India announcing the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024, it serves as a first framework guiding ethical marketing practices within the pharmaceutical industry in India. With its coverage of various aspects of marketing and promotional activities, UCPMP 2024 sets out various DOs and DON'Ts for the pharma companies . Here are...
New Delhi: With the Government of India announcing the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024, it serves as a first framework guiding ethical marketing practices within the pharmaceutical industry in India. With its coverage of various aspects of marketing and promotional activities, UCPMP 2024 sets out various DOs and DON'Ts for the pharma companies . Here are five significant takeaways from the UCPMP 2024 that pharmaceutical professionals should closely understand and implement in their operations.
1. Value Cap on Brand reminders in the form Informational and Educational Items
Informational and educational items are permitted under the UCPMP 2024, but with a specific cap in place to moderate their use. Items such as books, calendars, diaries, journals, and dummy device models, meant for professional healthcare settings, should not have an commercial value exceeding Rs. 1000 per item.
"Such items should not have an independent commercial value for the healthcare professionals," the guidelines further add. The giver and recipient of brand reminders should comply with the relevant provisions of the Income Tax Act, 1961 with respect to deductions and reporting of income, the guidelines also note
2. Volume Cap on Free Samples
The distribution of free samples to healthcare professionals by pharmaceutical companies is a common marketing practice. However, UCPMP 2024 places a stringent limit on these activities. The guidelines clearly state that Free samples of drugs shall not be supplied to any person who is not qualified to prescribe and such where samples of products are distributed by a medical representative, the sample must be handed directly to the person qualified to prescribe such product, or to a person authorized to receive the sample on their behalf, and the name and address of the healthcare practitioner noted for records.
Putting a cap on the volume of how many samples have to be given, the guidelines state that "Sample packs should be limited to prescribed dosage for not more than three patients for the required course of treatment and no company should offer more than twelve such sample packs per drug to any healthcare practitioner per year."
Putting a limit on the size of the sample, the guidelines add that each sample pack should not be larger than the smallest pack present in the market and that each sample should be marked "free medical sample not for sale" or bear another legend of analogous meaning. There is a complete BAN on the supply of a sample of a drug that is a hypnotic,sedative, or tranquilizer.
The guidelines further stress on accounting and record keeping, stating that Each company should maintain details such as product name, doctor name, quantity of samples given, date of supply of free samples to healthcare practitioners etc, and the monetary value of samples so distributed should not exceed two percent of the domestic sales of the company per year.
3. Continuing Medical Education (CME)
Engagement with healthcare professionals for Continuing Medical Education (CME) and Continuing Professional Development (CPD) must adhere to a transparent and verifiable set of guidelines. UCPMP prohibits Conduct of such events in foreign locations and even for India state that CME/CPD must be done withMedical Colleges/Teaching Institutions/Universities/Hospitals, Professional Associations of Doctors/Specialists, NIPERs, Laboratories of ICMR, DBT, CSIR etc, Pharma Colleges/other academic and research institutions. Pharmaceutical companies, including their trusts/associations, either alone or in collaboration with professional bodies, institutions mentioned before
What is important to note here is the call to transparency where UCPMP states that All pharmaceutical companies should share the details of such events conducted by them, including the expenditures incurred thereupon, on their website, and may be subject to independent, random, or risk-based audit for this purpose. All organizers of such events should explicitly spell out the procedure followed in the selection of participants and speakers, display a statement of their funding sources and expenditures on their website, and may be subject to special audit for this purpose.
Entities incurring expenditure on such events, as well as participants and speakers, must comply with the relevant provisions of the Income Tax Act 1961 as amended from time to time, the guidelines further add
4. Relationship with Healthcare Professionals
Taking cue from the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulation, 2002, the UCPMP reiterates the no- freebies clause for doctors
In particular the UCPMP bars the pharma companies from endulging in:-
Gifts: No gift should be offered or provided for personal benefit of any healthcare professional or family member (both immediate and extended) by any pharmaceutical company or its agent i.e. distributors, wholesalers, retailers, etc. Similarly, no pecuniary advantage or benefit in kind may be offered, supplied, or promised to any person qualified to prescribe or supply drugs, by any pharmaceutical company or its agent i.e. distributors, wholesalers, retailers, etc.
8.2 Travel: Companies or their representatives, or any person acting on their behalf, should not extend travel facilities inside or outside the country, including rail, air, ship, cruise tickets, paid vacations, etc., to healthcare professionals or their family members (both immediate and extended) for attending conferences, seminars, workshops etc., unless the person is a speaker for a CME or a CPD Program.
8.3 Hospitality: Companies or their representatives, or any person acting on their behalf, should not extend hospitality like hotel stay, expensive cuisine, resort accommodation etc., to healthcare professionals or their family members (both immediate and extended) unless the person is a speaker for a CME or a CPD program.
8.4 Monetary Grants: Companies or their representatives should not pay cash or monetary grant to any healthcare professional or their family members (both immediate and extended) under any pretext.
"Where any item missing, the Code as per the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulation, 2002, as amended from time to time, will prevail" the guidelines state
5. Regulation and Accountability
While there are no statutory penalities under the UCPMP as this will be a voluntary code implemented through pharma associations, a significant aspect of the UCPMP 2024 calls for the establishment of ethics committees by pharmaceutical associations to oversee compliance and address complaints which would be called Ethics Committee for Pharma Marketing Practices (ECPMP). The document details the process for lodging complaints, outlines the various penalties for pharma companies for breaches of the Code. These include possible expulsion from the association, mandated corrective actions, and potentially even recovery of improperly given benefits.
Whats important to note here, if a complainant is not happy with the dissatisfied with the decision of the ECPMP, they can an appeal before an Apex Committee for Pharma Marketing Practices (ACPMP) headed by the Secretary, Department of Pharmaceuticals, having a Joint Secretary and a Finance Officer dealing with the subject as its members
The UCPMP 2024 also requires a self-declaration of compliance from the chief executives of pharmaceutical companies, the Chief Executive Officer of the company itself is responsible for adherence to this Code, and a self-declaration in the format given in the annexure shall be submitted by the executive head of the company within two months of the end of every financial year to the Association for uploading on their website, or directly on the UCPMP portal of the Department of Pharmaceuticals in case he is not a member of such a body, or a member of more than one such bodies.
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