DoP Releases Draft Uniform Code For Medical Devices Marketing Practices

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New Delhi : The Department of Pharmaceuticals (DoP) has released the draft Uniform Code for Medical Device Marketing Practices (UCMDMP), a voluntary code laying standards for promotion, marketing and sales of the medical devices prohibiting distribution of gifts or benefits to healthcare professionals (HCPs), but allowing “modest, appropriate educational items” and “brand recall items” worth less than Rs. 1,000 occasionally.

The draft has been published after consultation with the industry and is open for wider stakeholder consultation. The feedback has to be sent to the department by not later than April 15, 2022.

The marketing practices of the Medical Device sector has been voluntarily regulated by the Uniform Code for Pharmaceuticals Marketing Practices (UCPMP), which prohibits the pharma companies or their agents from giving gifts, peculiarly advantages or benefits in kind offered or promised to persons qualified to prescribe or supply drugs or offer gifts for the personal benefit of HCPs and family members – both immediate and extended – such as tickets to entertainment events.

The Code for Medical Devices, however, elaborates the kind of gifts that will not be allowed and those which can be permitted. No gifts, peculiarly advantages or benefits in kind shall be supplied, offered or promised to persons qualified to use, prescribe or supply medical devices, by medical devices company or any of its agents and gifts for the personal benefit of HCPs and family members such as tickets to entertainment events shall not be offered or provided, under the UCMDMP.

However, 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,” said the draft Code. Companies should maintain adequate records to support any expenses on these educational materials.

Also, 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 recall items or brand reminders shall not exceed Rs. 1,000 and the companies shall maintain proper documentation on the expense incurred on such brand reminders, it said.

While at present it is a voluntary code, the government may consider making it a statutory code if it has not been implemented effectively by the industry associations and companies, it said.

Unlike the UCPMP published by the DoP in 2014, the Code for Medical Devices industry also has provisions for the company to collaborate with the HCPs and engage in activities including providing consulting services, conducting clinical studies and doing research, participate in company conducted training and education including continued medical education, product training’s, business meetings, webinars etc. However, such engagements shall not be conditional upon any obligation for the HCPs to use, recommend, promote or purchase products of the company.

Companies can directly or in collaboration with health care professionals or certain third parties conduct educational activities, product or procedure training programmes for in-service team of the hospitals on safe and effective use of the medical technologies, products and procedures, company’s promotional event such as seminar, conference of meeting for launch of a new product or technology or promoting an existing product or technology amongst HCPs. The broad categories of training and educational programmes also include continued medical education activities sponsored or funded by the company conducted by third parties including organisations controlled by a HCP, HCPs Association, event companies or any other entity for the purpose of group learning and skill upgradation for HCPs.

HCPs may participate in these programmes either as a faculty or training or proctor or as a delegate or trainee. In all these events, the HCPs as faculty/trainer/proctor can be provided with modest meals, travel reimbursement, hotel stay and honorariums for lectures, and HCPs as delegates or trainees can be provided with modest meals. For delegates and trainees, travel reimbursement and hotel stay are allowed if it is a company organised product and procedure training programmes or in-service programme, while it is not allowed for company conducted promotional programmes or third party conducted CME sponsored by companies for peer learning. Companies may also provide educational grants to training institutions and to other third-party entities in support of their legitimate scientific, educational and training programmes.

All the Medical Device Manufacturer Associations in India will have the Code uploaded on their website, and once a complaint is lodged and the Association receives the information from which it appears that a company may have contravened the code, the managing director or chief executive or equivalent of the company or authorised persons of the company concerned will be requested to investigate, take corrective actions and provide a response to the matters of complaint to the Association. The Association shall send the details of such complaints and status on a quarterly basis to the National Pharmaceutical Pricing Authority (NPPA). If the company is a member in multiple associations, the association that receives the complaint first shall communicate with the company and the company shall not be responsible to report to any other association.

In the UCPMP, the Associations were advised to form an ethics committee to look into the complaints and the penalty provisions include suspending or expelling the company from the Association, reprimanding the company and publishing details of that reprimand, and provisions for the committee to ask the company to recover the items from the concerned persons.

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