Patient safety, not cost, is key

The Indian healthcare industry has been on a growth trajectory through the last decade. Ayushman Bharat set yet another benchmark in this growth, assuring accessibility and affordability to all. However, it seems like the government has missed “quality healthcare”, a crucial aspect of healthcare services. The National Patient Safety Implementation Framework (NPSIF) 2018-2025 points out, “Laws, regulations, policies and strategies on the quality of care do exist in the country, however they are largely fragmented.” The framework also said, “there is minimal funding on patient safety research.”

The framework throws light on the need to use superior quality medical devices to ensure patient safety without compromising on the economic profile of patients. Let’s understand it with an example: Coronary Artery Disease (CAD) has reached the levels of an epidemic, responsible for 20% of all cardiovascular-related mortalities in the country. The burgeoning disease burden demands superior quality medical devices, such as new-age cardiac stents. As a medical practitioner, I am sure physicians would like to point out that every patient reflects varying symptoms and requires different cardiac stents based on evidence and science and not solely on pricing and affordability.

While the government taking cognisance of the need for patient safety is laudable, the road ahead is quite turbulent. To provide a patient “quality healthcare”, the government simply capped prices of cardiac stents. The National Pharmaceutical Pricing Authority (NPPA) fixed prices of cardiac stents — bare metal stents and drug-eluting stents (DES) at Rs 7,660 and Rs 27,890, respectively. While the price caps on stents put affordability and accessibility into play, the move pushes us back to the starting line. The move puts forward the “one-size-fits-all” principle, which is not patient-centric. How can you deny my right to choice and accessibility? Moreover, in a country that imports 75% of medical devices, a price-capping move will stall innovation from sustaining in the domestic market.

When the world is riding on the innovation curve, India is losing out on capitalising on the industry’s best stents. A cardiac stent depends on the material, thickness, design and clinical relevance. Global players have spent an enormous amount of manpower in developing cardiac stents which can arrest the developing disease profiles. For instance, DES mark a breakthrough in interventional cardiology, reducing angiographic restenosis and targeting vessel revascularisation. DES are coated with specific drugs to treat diabetic patients who can show signs of re-clogging of arteries.

While the new-age cardiac stents are ensuring successful patient outcomes by addressing different patient profiles, we are rewarding innovation with imposed price-cuts! Let’s not forget that price-capping cannot guarantee a reduction in the disease burden. Using a substandard medical device will result in repeat restenosis and poor management of the patient, requiring repeat procedures and thus escalating costs anyway. Therefore, short-term gains don’t justify long-term detrimental consequences.

Additionally, in a recent study, it was found that there was no significant increase in patient numbers post price-capping. The study revealed, “Amongst government hospitals surveyed, approximately 80% hospitals cited no significant increase in the number of angioplasty procedures performed, and even in the remaining 20%, the increase was marginal (2-5% only).”

Although trusted medical device manufacturers might not pull out of India immediately, imposing one ceiling for different cardiac stents will weaken the case for introduction and sustenance of new-generation stents in the Indian coronary stents market. No doubt the intent of the government is noble, but what if patients end up paying with the quality of their lives.

As a fundamental element of healthcare, patient safety is defined as freedom for a patient from unnecessary harm or potential harm associated with a medical intervention. Patient safety represents quality care dimensions alongside accessibility, acceptability and efficacy. An entire healthcare ecosystem of doctors, drugs, medical infrastructure, brands and medical devices etc., is responsible to ensure safe treatment to a patient. Since patient safety and reduction of preventable medical error is one of the major challenges of the 21st century, NPPA should have taken a more pragmatic approach before considering the same ceiling for all stents. I am not against price-capping, but it needs to be done in a pragmatic manner, keeping in view science and innovation and also the freedom of choice to the consumers based on their medical symptoms. Are we rewarding innovation by building medical infrastructure at par with global standards of safety or rationing it in the name of wider accessibility at the cost of quality and safety?

Whether or not the growth in medical device sector has percolated down to benefit the most vulnerable remains a relevant debate on patient safety.

(The writer is Founder, Partnership for Safe Medicines and Patient Safety and Access Initiative of India Foundation)