<p>In a notification earlier this month, the government decided to include stents as part of the National List of Essential Medicines (NLEM). I perform significant number of angioplasties every day and will be happy if any mechanism can make medical devices such as stents accessible to all patients. <br /><br /></p>.<p>At the same time, however, it is important to properly evaluate if this decision will actually benefit the intended beneficiaries like the patients, and meets three fundamental requirements — the price advantage is transferred to the patient, quality of care for the patient is maintained, it does not lead to entry of inferior products into the market and we still have access to a wide range of innovative medical devices for delivering best patient outcomes. <br /><br />NELM might compromise quality<br /><br />Coronary stents have halved the number of patients dying from heart attacks and implantable cardiac defibrillators have raised the chances of surviving a sudden cardiac arrest from 5% to 98%. Today, angioplasty is a safe and effective treatment for heart disease. Capping prices of stents by way of inclusion in NLEM might lead to issues of quality, halt technological innovation and promote shortages, ultimately compounding the problem of access. Sub-standard devices prolong recovery time, lead to repeat procedures and dramatically alter the prognosis for heart disease. <br /><br />Cardiac devices, like others, need frequent upgradation. New generation devices are the need of the hour, and any move that restricts price automatically limits innovation. Imposing a price cap also inhibits competition, thereby limiting the availability of newer, more effective devices from global markets. <br /><br />Evolving industry<br /><br />While we must take whatever steps are required to boost ‘Make in India’, it’s important to understand that the domestic medical devices industry is still evolving. There’s a long way to go for indigenous medical devices to attain the quality that every patient deserves. So until there is rigorous testing and evaluation of indigenous devices, the focus should be on improving access to the high quality devices already in the market. Policies must foster the development of a robust R&D ecosystem that enables global medical device makers to manufacture locally, thereby reducing import costs. <br /><br />Providing access to healthcare is central to ensuring that every Indian experiences the benefit of current economic growth. This is particularly relevant, since India bears a staggering 21% of the world’s disease burden. Apart from infectious diseases, non-communicable diseases (NCDs) like cancer, heart disease and diabetes are a growing public health menace. More than 53% of total deaths every year in the country are due to NCDs, and experts predict that over 60 million Indians will succumb to these by 2020. Despite the threat, the government’s priorities remain skewed towards reproductive, maternal and child health programmes — in 2015-16, a dismal 3% of the total healthcare budget was allotted for NCDs.<br /><br />Lack of extensive and adequately funded public health services compel millions of Indians to incur heavy out-of-pocket (OOP) expenses on private medical services. The link between out-of-pocket expenditure and poverty is confirmed in India’s draft National Health Policy 2015, which says that “55 million Indians fell into a serious poverty-trap because of their healthcare spending during the 2011-12 period.” The draft NHP also pronounces the country’s out-of-pocket expenditure for health to be one of the highest in the world, at 60%. <br /><br />Despite their widespread availability, however, stents and other critical devices don’t reach many who need them. Heart disease and diabetes are just two of the major NCDs that remain undiagnosed and untreated, largely because medical devices aren’t accessible. <br /><br />The government has suggested a price cap on these devices, in order to promote their widespread use. But this move will not improve matters, since the benefits of price reduction aren’t transferred to patients. In fact, the price of stents fell by 30% from 2011 to 2014. <br /><br />If the government really wants to stall the public health disaster that NCDs bring in their wake, it must adopt a broader multisectoral approach that strengthens the overall health infrastructure. <br /><br />The provision of universal health coverage for all Indians calls for a robust and functional health system backed by well-trained healthcare workers and doctors, innovative mechanisms of funding health services and access to essential medicines and technologies. <br /><br />Consistent policies and effective Public–Private Partnerships (PPPs) are the way forward — collaborations between the government, Indian researchers, clinicians and local and global device manufacturers will foster the spirit of innovation and ensure we meet global standards of quality and excellence in healthcare. <br /><br />Patient safety and well-being should drive all policy discussions and decisions. Keeping patient well-being at the centre of these discussions with quality of care and outcomes taking priority will help improve the healthcare scenario in the country.<br /><em><br />(The author is Chairman of Interventional Cardiology at Medanta - The Medicity)</em></p>
<p>In a notification earlier this month, the government decided to include stents as part of the National List of Essential Medicines (NLEM). I perform significant number of angioplasties every day and will be happy if any mechanism can make medical devices such as stents accessible to all patients. <br /><br /></p>.<p>At the same time, however, it is important to properly evaluate if this decision will actually benefit the intended beneficiaries like the patients, and meets three fundamental requirements — the price advantage is transferred to the patient, quality of care for the patient is maintained, it does not lead to entry of inferior products into the market and we still have access to a wide range of innovative medical devices for delivering best patient outcomes. <br /><br />NELM might compromise quality<br /><br />Coronary stents have halved the number of patients dying from heart attacks and implantable cardiac defibrillators have raised the chances of surviving a sudden cardiac arrest from 5% to 98%. Today, angioplasty is a safe and effective treatment for heart disease. Capping prices of stents by way of inclusion in NLEM might lead to issues of quality, halt technological innovation and promote shortages, ultimately compounding the problem of access. Sub-standard devices prolong recovery time, lead to repeat procedures and dramatically alter the prognosis for heart disease. <br /><br />Cardiac devices, like others, need frequent upgradation. New generation devices are the need of the hour, and any move that restricts price automatically limits innovation. Imposing a price cap also inhibits competition, thereby limiting the availability of newer, more effective devices from global markets. <br /><br />Evolving industry<br /><br />While we must take whatever steps are required to boost ‘Make in India’, it’s important to understand that the domestic medical devices industry is still evolving. There’s a long way to go for indigenous medical devices to attain the quality that every patient deserves. So until there is rigorous testing and evaluation of indigenous devices, the focus should be on improving access to the high quality devices already in the market. Policies must foster the development of a robust R&D ecosystem that enables global medical device makers to manufacture locally, thereby reducing import costs. <br /><br />Providing access to healthcare is central to ensuring that every Indian experiences the benefit of current economic growth. This is particularly relevant, since India bears a staggering 21% of the world’s disease burden. Apart from infectious diseases, non-communicable diseases (NCDs) like cancer, heart disease and diabetes are a growing public health menace. More than 53% of total deaths every year in the country are due to NCDs, and experts predict that over 60 million Indians will succumb to these by 2020. Despite the threat, the government’s priorities remain skewed towards reproductive, maternal and child health programmes — in 2015-16, a dismal 3% of the total healthcare budget was allotted for NCDs.<br /><br />Lack of extensive and adequately funded public health services compel millions of Indians to incur heavy out-of-pocket (OOP) expenses on private medical services. The link between out-of-pocket expenditure and poverty is confirmed in India’s draft National Health Policy 2015, which says that “55 million Indians fell into a serious poverty-trap because of their healthcare spending during the 2011-12 period.” The draft NHP also pronounces the country’s out-of-pocket expenditure for health to be one of the highest in the world, at 60%. <br /><br />Despite their widespread availability, however, stents and other critical devices don’t reach many who need them. Heart disease and diabetes are just two of the major NCDs that remain undiagnosed and untreated, largely because medical devices aren’t accessible. <br /><br />The government has suggested a price cap on these devices, in order to promote their widespread use. But this move will not improve matters, since the benefits of price reduction aren’t transferred to patients. In fact, the price of stents fell by 30% from 2011 to 2014. <br /><br />If the government really wants to stall the public health disaster that NCDs bring in their wake, it must adopt a broader multisectoral approach that strengthens the overall health infrastructure. <br /><br />The provision of universal health coverage for all Indians calls for a robust and functional health system backed by well-trained healthcare workers and doctors, innovative mechanisms of funding health services and access to essential medicines and technologies. <br /><br />Consistent policies and effective Public–Private Partnerships (PPPs) are the way forward — collaborations between the government, Indian researchers, clinicians and local and global device manufacturers will foster the spirit of innovation and ensure we meet global standards of quality and excellence in healthcare. <br /><br />Patient safety and well-being should drive all policy discussions and decisions. Keeping patient well-being at the centre of these discussions with quality of care and outcomes taking priority will help improve the healthcare scenario in the country.<br /><em><br />(The author is Chairman of Interventional Cardiology at Medanta - The Medicity)</em></p>
