New Code bars medical device companies from giving GIFTS to doctors

These gifts of entertainment and recreational activities include, among others, theater, live comedy or musicals, sporting events, golf, skiing, cruises, spas, or vacation trips.

These directions have been issued by the Department of Pharmaceuticals- under Ministry of Chemicals & Fertilizers in the recently released Uniform Code for Medical Device Marketing Practices (UCMDMP), which has been formed on the request of the MedTech Industry for having a separate uniform code for the Medical Device Sector.

Until now, the marketing practices of the Medical Device Sector were being voluntarily regulated by Uniform Code for Pharmaceuticals Marketing Practices (UCPMP).

Also Read: Pharma Freebies to Doctors: Supreme Court announces its verdict

Establishing the relationship between the Health care professionals (HCP) and the Medical Devices companies, the draft mentioned, "A HCP's first and highest duty is to act in the best interests of their patients. Medical Device Companies should help HCPs meet this duty through necessary, collaborative interactions without interfering with their professional autonomy and the autonomy of the medical institutions that the HCPs may be associated with. Specifically, Companies may collaborate with HCPsand engage in activities including but not limited to providing consulting services, conducting clinical studies and doing research, participate in Company conducted training & education (physical and digital platform) including continued medical education, product trainings, business meetings, webinars etc. In no event, the engagements/collaboration with the HCPs shall be conditional upon any obligation for the HCPs to use, recommend, promote or purchase products of the Medical Device Companies or any of its affiliate's or intended to influence HCPs to do so."

However, the draft has clarified that while engaging with the HCPs for such programs, Companies shall strictly ensure that,

"7.2 Cash or monetary grants: Companies or their associations/representatives shall not pay any cash or monetary grants to any HCP for individual purpose in individual capacity under any pretext. However, Companies may provide educational grants to training institutions (such as medical schools, teaching hospitals, hospitals & institutions having approved teaching seats) and to other third-party entities in support of their legitimate scientific, educational and training programs and other activities ("Third Party Program"). This includes, but is not limited to, educational grants to support the education and training of health care and medical personnel (for example, physicians, medical students, residents, fellows, or other HCPs-in-training or in practice), patients, government officials and regulators (per approval from respective institutions and as per applicable laws and applicable service rules), and the selected patient group/public about important health care topics. Such grants shall be made as per the modalities laid down by law/rules/guidelines adopted by such institutions, in a transparent manner. It shall always be fully disclosed, and Companies shall maintain adequate records of such grants in their books.

7.3 Consultancy/ Honorariums: Companies engage HCPs to provide a wide range of valuable, bona fide consulting services for education purposes under a consultancy contract/ agreement involving consultancy fee/ Honorariums based payment to HCPs based on fair market value for the specific scope of services. Some examples include arrangements for a HCP to provide education and training (including online), speaking services, proctorships (evaluate), preceptorships (instruct), reference center or center of excellence services, participation on advisory boards or focus groups, Medical Device development and research services arrangements (such as research and development, clinical studies, clinical trials, clinical investigator services, collaborative research, and post-market research), and arrangements for the development or transfer of intellectual property. Such consultancy contract shall record the agreed terms fully in transparent manner and shall be disclosed, if required to do by appropriate authority. Companies shall maintain adequate records for any expenses / fee paid as per such consultancy contracts.

7.4 Prohibition of Entertainment & Recreation: Companies shall not provide or pay for any entertainment or recreational event for HCPs, their staff or their family. Some examples of entertainment and recreational activities include, among others, theater, live comedy or musicals, sporting events, golf, skiing, cruises, spas, or vacation trips. This prohibition applies regardless of (1) the value of the activity; (2) whether the Company engages the HCP as a consultant; or (3) whether the entertainment or recreation is secondary to an educational purpose.

7.5 Third Parties educational activities /CMEs: Companies shall document a clear understanding that amount of sponsorship or education grant contributed by Company toward the third party conducted event, shall be spent only for legitimate purposes and in compliance with this UCMDMP code and/or applicable laws. Further, for any such third-party events, no Direct sponsorship of a health care professional to a third-party program is permitted. Companies are not permitted to pay, offer to pay or offer to reimburse any expense (e.g., travel, stay, local travel, honorarium etc.) in support of attendance of health care professionals to third-party programs as faculty. Companies must not select or influence selection of health care professional attendance to third-party program. Companies may engage HCPs under a professional services agreement for a company-conducted satellite symposium held alongside third-party programs and may compensate in accordance with fair market value. Travel and lodging should be considered only if the health care professional is travelling solely for the satellite symposia which is organized by the Company.

7.6 The documents/records required to be maintained under this Clause shall be maintained by Company for a period, as per applicable laws specific to category of document/record and in absence of such applicable laws as per Company's record management policy."

Regarding giving gifts to Health care professionals, the draft code mentions a clear policy of NO gifts,

"6.1 No gifts, pecuniary advantages or benefits in kind shall be supplied, offered or promised to persons qualified to use, prescribe or supply Medical Devices, by a Medical Device Company or any of its agents i.e., distributors, wholesalers, retailers etc.
6.2 Gifts for the personal benefit of HCPs and family members (both immediate and extended) (such as tickets to entertainment events) shall not be offered or provided.

6.3 Companies may occasionally provide modest, appropriate educational items to HCPs that benefit patients or serve a genuine educational function for HCPs. Educational items can include but are not limited to product manuals and anatomical models. Hence, Companies can supply Medical education materials like books including e-books,and subscription to online portals (that can help download the materials for medical education and knowledge dissemination), anatomical models, bone/animal models, manuals and small products/educational material related to the training/Continued Medical Education (CME)/in hospitals or in clinic training, to HCPs or institutions. Companies should maintain adequate records to support any expenses on above educational material.
6.4 Companies may occasionally provide modest, appropriate brand recall items/ brand reminders, which are customary business courtesies and are reasonable in value and frequency. However, the value of such brand recalls items/ brand reminders shall not exceed INR 1,000 (Rupees One Thousand). Companies shall maintain proper documentation with respect to expense incurred on such brand reminders.
6.5 The documents/records required to be maintained under this Clause shall be maintained by Company for a period, as per applicable laws specific to category of document/record and in absence of such applicable laws as per Company's record management policy."

Such a step by the Department of Pharmaceuticals should be read in continuation with the recent amendments which have been brought in place by the Government to put a stop to pharma freebies.

Medical Dialogues had earlier reported that the new Finance Budget had clarified that- any claims of expenses incurred while providing benefits to others that violate the provisions of Indian Medical Council Regulations, 2002 shall be inadmissible for a tax deduction.

It was stated in the explanatory memorandum to the Finance Bill 2022 that, "The legal position is clear that the claim of any expense incurred in providing various benefits in violation of the provisions of Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 shall be inadmissible under section 37 of Act being an expense prohibited by the law."

Previously the step had been taken to curb unethical bribing of doctors by the pharma companies and now similar law is being laid down for the Medical Devices industry as well.

Releasing the Uniform Code, the Department of Pharmaceuticals has invited feedbacks and inputs on it within April 15.

The notice stated, "To have a wider stakeholder consultation, the draft UCMDMP is hereby published (Annexure) to seek specific comments from the Public/ Medical Device Industry representatives and associations/ other stakeholders."

"While giving the inputs, it may be kept in mind that UCMDMP is proposed to be a voluntary code. The feedback/inputs may be sent at ucmdmp-2022@gov.in (in both PDF and Word document) by not later than 15.04.2022.

Click here, to view the draft.