New Delhi: Recently the union health ministry issued a notification announcing that coronary stents would be added to the 2015 National List of Essential Medicines (NLEM) as per the recommendations of a Subcommittee established late last year. The step has created a bit of controversy as it has come under criticism from many quarters including the multi-national medical technology companies.
In a statement issue to media on July 20th, the AdvaMed (Advanced Medical Technology Association) has opposed the government’s move by arguing that the stents and medical technology generally do not meet the criteria for inclusion in the NLEM. According to The World Health Organization, 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,” said the statement.
AdvaMed also feels that the government’s move to include stents in the National list of essential medicines in order to influence the price of medical devices is detrimental to the nascent medical device industry 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 benefitted patients so far as the overall procedure cost has largely remained the same,” mentioned the statement further.
The premier medical technology association has called for 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.