In this article, we have attempted to provide some respite to the age-old debate between the legal and marketing heads of the MedTech companies in respect of how to classify the activities /interactions with healthcare professionals (HCPs), whether these are awareness or advertisement activities. For MedTech companies, their consumers are either hospitals or the retail end-users, and this element makes it quintessential for them to approach, partner, and collaborate with the HCPs for any activity in relation to their products, services, and usage.
II. Advertisement and Promotional Activities
Advertisement is a powerful tool that helps any business attract customers, introduce, and inform them about products and services, and build trust. However, with the galloping MedTech industry, advertising of medical devices and services in India has attracted due attention of the government authorities to protect the interests of the consumers from misleading and unethical marketing practices.
Under the Indian laws, companies must only make claims in respect of a medical device which is based on an up-to-date evaluation. While comparative advertisements are allowed, it must be factual, fair, and capable of substantiation, but the same must not mislead the end-users in any way and while doing so, the brand names of products of other companies must be used only with prior consent for the same.
The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 ("DMRA"), was enacted to control the advertisement of drugs in certain purposes of remedies alleged to possess magic qualities, and it covers all advertisements which are objectionable and unethical and are used to promote self-medication or self-treatment.1 The DMRA defines advertisement which includes 'any announcement made orally or by any means of producing or transmitting light, sound or smoke'.
Further, the Central Consumer Protection Authority has the power under the Consumer Protection Act, 2019 ("CP Act"), to investigate, order, issue directions, if any advertisement is false or misleading and is prejudicial to the interest of any consumer or is in contravention of consumer rights. The CP Act defines terms like 'advertisement', 'endorsement' and 'misleading advertisement', and further treats false and misleading representation with respect to any product or services as an 'unfair trade practice'. In addition, the Guidelines for Prevention of Misleading Advertisements and Endorsements for Misleading Advertisements, 2022 ("Prevention of Misleading Advertisements Guidelines") is notified by the Central Consumer Protection Authority with the objective to curb misleading advertisements and protect the consumers who may be exploited or affected by such advertisements. The Central Consumer Protection Authority has the power under the Prevention of Misleading Advertisements Guidelines as well as the CP Act, to impose monetary penalties for contravention of the guidelines prescribed therein.
The Department of Pharmaceuticals of the Ministry of Chemicals and Fertilizers, Government of India, in consultation with the MedTech industry, published the draft Uniform Code for Medical Device Marketing Practices ("UCMDMP") on March 16, 2022, which is still at a draft stage. The proposed UCMDMP addresses the marketing practices of the medical devices sector which are currently regulated under the Uniform Code of Pharmaceutical Marketing Practices ("UCPMP"). While adoption of the proposed UCMDMP and UCPMP is voluntary, compliance should be ensured if the concerned MedTech company has adopted it. The UCMDMP defines 'promotional materials' as any material used for commercial promotion (for sales and marketing purpose). However, under the proposed UCMDMP, the definition of 'promotional material' specifically excludes educational materials such as surgical technique portrayal, disease awareness material, research/ clinical material, evaluation reports or information/ documents as mandated by regulatory provisions from time to time.
In addition, the Advertising Standard Council of India (ASCI), a self-regulating body which has received recognition from the Supreme Court of India, various government ministries and organizations as well as statutory recognition under the Cable Television Network Rules, 1994, regulates promotional/advertising content across sectors to ensure protection of interest of consumers through the Code for Self-Regulation of Advertising Content in India ("ASCI Code"). The Consumer Complaints Council (CCC) of ASCI functions as its examining body which considers complaints raised as well as the response of the advertiser, whether such advertiser is a member or a non-member of ASCI, before giving its recommendations as to whether the advertisement in question violates the provisions of the ASCI Code. Although ASCI Code does not set any specific standards for advertisements of medical devices, at various instances, ASCI has held advertisement as inadequately substantiated or misleading.
Mr. Anuranjan Prasad, Associate General Counsel at a large MedTech multi-national company (MNC) says, "It is essential for MedTech companies to ensure continuous adherence with the regulations surrounding marketing and advertisements in India. In such a highly regulated sector, periodical educational drives and training exercises for the sales and marketing teams of the MedTech companies, ensure continuous adherence with the applicable regulations."
III. Awareness Activities
Just like advertising to customers, awareness activities directed at or with HCPs, inter alia, help them to stay abreast of the details of the latest products and services, and their workings to enable them to be better equipped to serve the patients or end-users who may be in need of such products and services. MedTech companies in collaboration with HCPs conduct various product and therapy awareness activities which help in penetration of healthcare and creates awareness about ailments and its treatments. However, this area is highly regulated to protect the nobility of the profession of HCPs as well as safeguard the interests of the consumers. To ensure the same, the Indian lawmakers are striving towards enacting more stringent laws for protection of the interests of the masses, some of which can be seen, inter alia, in the proposed UCMDMP, UCPMP, CP Act and the rules, regulations and guidelines thereunder.
Ms. Meeru Gupta, Director - Legal and Compliance at Philips India Limited ("Philips"), says, "HCPs are trained personnels and MedTech Companies need to interact with them on a daily basis for feedback and further research for introduction of new and improvised technologies which results in reduced work pressure; and show casing new equipment to HCPs." Ms. Gupta further shares, "We, at Philips, have curated an internal playbook on 'Do's and Don'ts' for interaction with HCPs, for sales personnels. Further, Philips has a gift registration tool as well as a hospitality tool to make appropriate disclosures in this regard. Training our personnels is the key to keep Philips compliant with the applicable laws, which is why Philips regularly conducts in-person training activities for sales personnels to increase learnings."
In compliance with the proposed UCMDMP and UCPMP, while specific restrictions are imposed on medical representatives in respect of any inducement or subterfuge, to gain an interview, or pay, under any guise, for access to HCPs, companies employing such representatives are responsible for such activities or interactions with HCPs. However, medical representatives may play a role in a clinical setting by providing technical support on the safe and effective use of a medical device, in compliance with applicable hospital or facility policies and requirements, including patient privacy and credentialing requirements.
In addition, companies or any of their agents are prohibited to offer, supply, or promise any gifts, pecuniary advantages, or benefits in kind (including payment towards entertainment and recreational activities), to HCPs and their family members, to use, prescribe or supply their products. Nevertheless, they may occasionally provide modest, appropriate brand recall items/ brand reminders, which are customary business courtesies and are reasonable in value and frequency, not exceeding INR 1,000 (Indian Rupees One Thousand only), subject to maintenance of proper documentation with respect to such expenses incurred on such items. Moreover, MedTech companies are prohibited from paying any cash or monetary grants or direct sponsorship to any HCP for individual purpose in individual capacity under any pretext, but, providing educational grants to training institutions (such as medical schools, 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, is permitted.
Further, as per the proposed UCMDMP, MedTech companies directly or in collaboration with HCPs and other third parties are allowed to conduct educational activities with an objective of: (a) advancement of medical care and clinical science; (b) instruction, education, and training HCPs on safe and effective of use of medical technology; (c) providing product service and technical support; and (d) supporting scientific and medical research of HCPs. Some broad categories of training and educational programmes permitted under the proposed UCMDMP are: (a) company conducted product and procedure training programs/ in-service program; (b) company conducted seminar, conference, or meeting for or launch of a new product and/or technology or promoting an existing product or technology amongst HCPs; (c) third party conducted continued medical education (CMEs) activities, wholly or partially sponsored/ funded by Company. Training and educational programmes, and HCP engagement may have direct or indirect influence on the patients/ end-users of the medical devices/therapies, in which HCPs may participate as faculty/ trainer/ proctor, or delegate/ trainee.
The proposed UCMDMP and UCPMP prohibit the use of the name and photographs/recordings of HCPs in promotional materials of a product. Further, the Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002 ("Professional Conduct Regulations") regulate and consider any direct or indirect solicitation of patients by physicians, institutions, or organisations as unethical, including any direct or indirect influence by the HCPs through use of their names and photographs in promotional materials. Therefore, any marketing/ promotional activities in relation with the sales by a MedTech company, and any direct or indirect influence by the HCPs through using their names and photographs in promotional materials is restricted / prohibited.
It may be pertinent to note that the aforesaid restrictions are with respect to promotional materials, i.e., commercial promotion for sales and marketing purposes, as defined under the proposed UCMDMP, subject to specific exclusions provided therein. Moreover, under the Consumer Protection Act, 2019, the term 'endorsement' has been defined and includes endorsements by (i) individuals; and (ii) institutions/ organizations. The critical element of an endorsement is the fact that it leads the consumer to believe that it is the opinion or the finding or the experience of the person/ institution/ organisation making the endorsement.
As discussed above, HCPs are allowed to conduct therapy awareness, and other training and educational programmes. However, any user experience provided by the HCPs in their testimonials should be verified and moderated to ensure that such user experiences provided by the HCPs do not amount to 'endorsement', as defined under the applicable Indian laws. Moreover, HCPs providing their user experience for products/services of the MedTech companies, should do so in their independent professional capacity and the same should not, in any manner, be induced or influenced.
IV. US law perspective on Interaction with HCPs
Mr. Joe Coli, Partner at CTM Legal Group, a law firm based out of Chicago, Illinois, shares his perspective on interaction with HCPs in the US. Mr. Coli says, "MedTech companies in the US are subject to strict regulations governing their ability to advertise, promote, and interact with HCPs, which is primarily regulated by the US Food and Drug Administration. In the US, MedTech companies are allowed to interact with HCPs to provide information about their products, but this interaction must follow strict guidelines. For instance, MedTech companies must ensure that any information they provide to HCPs is accurate and not misleading. Additionally, they must disclose any potential conflicts of interest, such as financial ties to HCPs or institutions. MedTech companies are also required to comply with additional regulations, such as the Physician Payment Sunshine Act of 2009, which requires companies to report any payments or gifts they provide to HCPs.2 These laws are designed to prevent conflicts of interest and ensure that HCPs make decisions based on unbiased information."
In conclusion, Mr. Coli shares, "MedTech companies in the US are permitted to advertise, promote, and interact with HCPs, subject to compliance with strict regulations designed to ensure that information provided to HCPs are accurate and unbiased."
For reference, important Indian laws applicable to awareness and marketing activities for MedTech companies are:
- Drugs and Cosmetics Act, 1940;
- Medical Devices Rules, 2017;
- Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954;
- Consumer Protection Act, 2019;
- Guidelines for Prevention of Misleading Advertisements and Endorsements for Misleading Advertisements, 2022;
- Uniform Code for Pharmaceuticals Marketing Practices;
- Draft Uniform Code for Medical Devices Marketing Practices;
- Advertising Standards Council of India's (ASCI) Code for Self-Regulation of Advertising Content in India; and
- The Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002.
*Link Legal presents 'MedTech Law Event', engulfing series of focused articles and webinars on the MedTech Industry and its impact on the healthcare delivery. Join Link Legal on Tuesday, 4 April 2023 for an informative and engaging webinar on "Laws relating to interaction with Healthcare Professionals (HCPs)".
To know more and register for the webinar, click here.
1. Hamdard Dawakhana (Wakf) Lal Kuan, Delhi v. Union of India, AIR 1960 SC 554.
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