There should be more clarity and a comprehensive, consultative multi-stakeholder approach according to the industry bodies
The Health Ministry’s recent notification announcing that coronary stents would be added to the 2015 National List of Essential Medicines (NLEM) has been severely criticised by major industry bodies like CII, FICCI and Advanced Medical Technology Association (AdvaMed).
In a statement, Himanshu Baid, Chairman, CII Medical Technology Division said, “The government’s move to include stents in NLEM is contradictory to its recent efforts to press forward with legislation that would create separate and appropriate legislations for medical devices.”
Baid reasoned that given the clear distinction between medical devices and drug formulations, the methodology for price control of drug formulations cannot be applied to medical devices. In response to government’s call, CII members have already submitted their proposal of voluntary price reduction to the Ministry of Health and Family Welfare and other departments enabling access of “value stent” at CGHS prices below Rs 25,000 to all patients. According to him, many companies have already reduced price of good quality stents as proposed in CII proposal.
Baid concluded, “A price control on nascent medical devices sector at this stage does not bode well in creating a conducive environment for FDI, realising Make in India or investment in R&D, both of which are required for growth of this sector.”
Probir Das, Chairman, FICCI Medical Device Forum, too criticised the decision saying, “Unilateral and unsuitable price controls on stents and medical devices will adversely affect the usage of innovative and high quality products in India and thus reduce the levels of patient outcomes. This will have an unfavourable impact on ‘Make in India’ intentions and FDI inflow in the sector.”
He added, “Innovation and incremental improvement is the foundation of the medical devices sector that has to regularly invest in research and development for upgrading medical technology for the benefit of the patients. Price controls create disincentive for manufacturers to bring new technology to market.”
AdvaMed pointed out that stents and medical technology generally do not meet the criteria for inclusion in the NLEM. According to the WHO, the methodology used for medicines cannot be replicated with medical devices when it comes to ‘essentiality.’ Moreover, coronary stents is a category and not products, just like antibiotics/ vaccines are also a category of medicines, which have different drug molecules within them, which can be essential.
AdvaMed’s statement opined that the move to include stents in NLEM in order to influence the price of medical devices is detrimental to the nascent medical device industry, which committed to improve access to quality healthcare and medical devices in India. The quality of products and clinical outcomes do not seem to have been given a priority. Singular focus on capping prices of stents by way of their inclusion in NLEM will not help improve access to medical devices for patients, as it will not impact the overall procedure cost and limit the introduction of innovative products. Also, according to the recent IMS Health Data on stents, price of stents in India is not the highest contributor to the overall angioplasty cost. The data showed that significant reduction in stent price over the last four years has not benefited patients so far as the overall procedure cost has largely remained the same.
More clarity and a comprehensive, consultative multi-stakeholder approach that involves contributions from all stakeholders in the healthcare ecosystem is the need of the hour, mentioned AdvaMed.
EH News Bureau
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