If the Unified Code of Practice for Marketing of Medical Devices remains voluntary, will we repeat the mistakes made with the Pharmaceutical Marketing Code?

On March 16, the Department of Pharmaceuticals (DoP) published the draft Unified Code of Marketing Practice for Medical Devices (UCMDMP) as a voluntary code to regulate the marketing practice of the medical device industry.

The project was a response to industry demand for a code different from the Unified Code of Pharmaceutical Marketing Practice (UCPMP) because the two sectors have significant differences. Therefore, industry associations predictably assessed the draft code. Pavan Chudary, Chairman and CEO, Medical Technology Association of India (MTaI) linked the release of the UCMDMP project with the Modi government’s move towards “continuously expanding the circle of honesty”. His statement praised the government for “voluntary compliance with the UCMDMP (which is the right way)” as it is to the satisfaction of every company that adheres to a high level of ethical standards. This will undoubtedly lead to more reliable medical services, as well as restraining the flight of night operators, which pose a great danger to patients and the reputation of the medical device industry. “

Choudary hopes that over time, UCMDMP will “separate the husk from the grain and give ethical players the public respect they deserve. We hope that its impact will also spread and test those operators who have found a way to circumvent the control of prices for medical devices, which are planned in the regime of this government.

Are we repeating the same mistakes made with the code of pharmaceutical marketing? The UCPMP remains voluntary more than ten years after it was introduced in 2011. While the pharmaceutical industry associations claim that their member companies follow, medical representatives and patient activist groups may differ.

In fact, just a couple of days before the release of the UCMDMP project, Art Supreme Court issued a notice in response to a statement by the Federation of Medical and Trade Representatives Association of India (FMRAI) requesting to make the UCPMP more effective by providing a mechanism for monitoring, transparency, accountability, and the consequences of violations. Obviously, while the intention is good, the UCPMP has not fulfilled its goal and remains a paper tiger.

However, the 15-page UCMDMP project seems to reflect some lessons learned from the UCPMP experience. Legal experts note that the draft Medical Devices Code extends the definition of healthcare worker (MHP), while the UCPMP did not have such a definition.

Therefore, the code of medical devices will expand to cover healthcare professionals authorized or licensed in India to provide medical services or items to patients as well as involved in the decision to purchase, prescribe, order, use or recommend a medical device in India.

The draft Medical Device Code states that the term HCP includes individual clinicians (e.g., physicians, nurses, technicians, and pharmacists, OT staff, ophthalmologists, pathologists, transfusion specialists, laboratory technicians, among others), supplier entities (e.g. , hospitals, outpatient surgical centers, pathology laboratories, blood banks, among others) and administrative staff of supplier organizations in India (e.g., hospital procurement agents). This term does not include health professionals who are conscientious employees of the company, while performing their duties.

Another difference is that if the UCPMP was short, the medical device code develops and explains what is allowed and what is not when it comes to interactions between the medical device industry and health professionals, mentioning specific examples when it comes to allowed gifts. pemotional materials, train and educational programs, cashes or cash grants, consultations / fees and third party activities.

Will there be an outcome in the medical device sector, given that the regulator has limited capabilities when it comes to monitoring and enforcing the Voluntary Code? Although the draft states that “if it is found that it has not been effectively implemented by associations / companies of medical devices, the government may consider adopting it into the statutory code”, the fact that The UCPMP remains voluntary ten years after its release making the threat empty. There are all indications that this will become another paper tiger that will have little effect on the cost of medical devices used by millions of unfortunate patients in India.

The names and shame of hospitals and doctors for accepting “gifts” from pharmaceutical companies did not work as a deterrent because public memory is short. Can we hope that all stakeholders adhere to the code of practice for marketing medical devices in letter and spirit? After all, disease and death do not distinguish between those who own a scalpel and those who are under it.

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