If the Uniform Code for Medical Device Marketing Practices remains voluntary, will we repeat missteps made with the pharma marketing code?
On March 16, the Department of Pharmaceuticals (DoP) released the draft Uniform Code for Medical Device Marketing Practices (UCMDMP), as a voluntary code to regulate marketing practices by the medical device industry.
The draft was in response to industry’s request for a code distinct from the pharmaceutical sector’s Uniform Code for Pharmaceuticals Marketing Practices (UCPMP), as the two sectors have substantial differences. Industry associations have therefore predictably hailed the draft code. Pavan Choudary, Chairman & Director General, Medical Technology Association of India (MTaI) linked the release of the draft UCMDMP to the Modi government’s move to “constantly widening the circle of probity.” His statement commends the government for “following through the implementation of the UCMDMP voluntarily (which is the right way to go about it)” as it “is heartening for every company which follows a high level of ethical standards. It will surely translate into more credible healthcare delivery as well as restrain the fly by night operators- who pose a great risk for patients and the reputation of the medical device industry.”
Choudary hopes that in time, the UCMDMP will “separate the chaff from the grain and give the ethical players the public esteem they deserve. Its impact will hopefully also spill over and check those operators who have found a way to circumvent the price control affected on scheduled medical devices in this government’s regime.”
Are we repeating the same missteps made with the pharma marketing code? The UCPMP remains voluntary more than a decade after it was introduced in 2011. While pharma industry associations claim adherence by their member companies, medical representatives and patient activist groups beg to differ.
In fact, just a couple of days before the release of the draft UCMDMP, the Supreme Court issued notice in response to a plea filed by the Federation of Medical & Sales Representatives Association of India (FMRAI) asking that the UCPMP be made more effective by providing a monitoring mechanism, transparency, accountability as well as consequences of violations. Clearly, while the intent is good, the UCPMP has not served its purpose and remains a paper tiger.
That said, the 15-page draft UCMDMP does seem to reflect some lessons learnt from the experiences of the UCPMP. Legal experts have pointed out that the draft medical devices code expands the definition of a healthcare professional (HCP), whereas the UCPMP did not have such a definition.
Hence the medical devices code will expand to cover health care professionals authorised or licensed in India to provide health care services or items to patients as well who are involved in the decision to purchase, prescribe, order, use or recommend a medical device in India.
The medical device draft code specifies that the term HCP includes individual clinicians (for example, physicians, nurses, technicians and pharmacists, OT staff, optometrists, pathologists, transfusion professionals, lab technicians, among others), provider entities (for example, hospitals, ambulatory surgical centers, pathology labs, blood banks amongst others), and administrative personnel at provider entities in India (for example, hospital purchasing agents). This term does not include health care professionals who are bona fide employees of a company, while acting in that capacity.
Another difference is that while the UCPMP was concise, the medical device code elaborates and explains what’s allowed and what’s not, when it comes to interactions between med device industry and HCPs, mentioning specific examples when it comes to gifts allowed, promotional materials, training and educational programmes, cash or monetary grants, consultancy/honorariums, and third-party events.
Will the outcome be any different with the medical devices sector, given that the regulator has limited options when it comes to monitoring and enforcing a voluntary code? Even though the draft says that “if it is found that it has not been implemented effectively by the Medical Device Associations/Companies, the Government may consider making it a statutory code’, the fact that the UCPMP remains voluntary a decade after its release makes this threat ring hollow. There are all signs that this will become yet another paper tiger, making little to no impact on the cost of medical devices footed by millions of hapless patients in India.
Naming and shaming hospitals and doctors for accepting ‘gifts’ from pharma companies has not worked as a deterrent as public memory is short. Can we hope that all stakeholders adhere to the medical devices marketing practices code in letter and spirit? After all, disease and death does not differentiate between those who wield a scalpel and those who are under one.
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