Limited quantity of samples, no gifts, offers for recreational activities such as theatre, live comedy or musicals, sporting events, golf, skiing, cruises, spas, or vacation trips — the Narendra Modi government has prepared a code for marketing practices to arrest the unethical bribing of doctors by the medical devices industry.
Medical devices have so far been treated at par with drugs. While the pharmaceutical sector has its own set of codes, different ones have been drafted for the medical devices sector as the government moves to regulate the latter as a separate industry going forward.
While the code will be “voluntary” for the industry, emphasising self-regulation, the government warns that it may make it “statutory” if not implemented well.
The Department of Pharmaceuticals — under the Ministry of Chemicals and Fertilizers — has released a draft uniform code for medical device marketing practices. Dated March 16, the draft requests for feedback from the industry representatives by April 15.
According to the draft, the medical devices sector forms an “important pillar” in the healthcare delivery system and it will help achieve the key values enshrined in the National Health Policy 2017 in terms of provision of good quality, affordable, and comprehensive healthcare to all citizens.
Based on the request of the MedTech industry to have a separate uniform code and having realised such needs, the draft said that the “department has prepared a separate Uniform Code for Medical Devices Marketing Practices (UCMDMP) in consultation with the industry”.
The draft UCMDMP is a voluntary code and its implementation will be reviewed after a period of six months from the date of its issue. “If it is found that it has not been implemented effectively by the medical device association and companies, the government may consider making it a statutory code,” the 16-page draft document said.
Highlights of the Draft
The document is similar to the codes regulating the pharmaceuticals industry. According to the document, “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.”
The code bars gifting for the personal benefit of doctors and their family members (both immediate and extended) perks such as tickets to entertainment events. Companies will be asked to “not pay any cash or monetary grants to any healthcare provider 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 and institutions having approved teaching seats and to other third-party entities in support of their legitimate scientific, educational and training programs and other activities.
Also, companies will be allowed to occasionally provide modest, appropriate educational items to doctors that “benefit patients or serve a genuine educational function for HCPs”.
Also, companies may occasionally provide modest, appropriate brand recall items that are reasonable in value and frequency. “However, the value of such brand recalls items/ brand reminders shall not exceed Rs 1,000.”
Companies will be asked to maintain proper documentation with respect to expenses incurred on such brand reminders. Companies will be barred from providing or paying for any entertainment or recreational event for doctors, their staff or their family.
Some examples of entertainment and recreational activities, as per the draft, include theatre, live comedy or musicals, sporting events, golf, skiing, cruises, spas, or vacation trips.
In case of any wrongdoing, the managing director or chief executive officer or an authorised signatory of the company will be held as “ultimately responsible for ensuring the adherence to the code and a self-declaration…”
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