Can price-control affect quality of device patients get?

As the Centre trains its guns on high-priced medical devices to bring down the overall cost of treatment, another fear is surfacing in hospital corridors on quality.

Are patients getting quality products suited to their condition? And will these products be available in the market, six months on? These questions from patients to their doctors reveal a palpable fear, as rumours abound that it may become unviable to continue selling in India scientifically superior products.

It’s been over a month since the government cracked its whip on the exorbitant margins and prices of cardiac stents (used to remove heart blockage) with a plan to expand this price monitoring to other devices including intra-ocular lenses and hip replacements. The concern in some quarters is whether this move to benefit patients could end up having the opposite effect if companies stop short of supplying their best to Indian patients.

Welcoming the government move to bring down prices, cardiac surgeon Devi Shetty says that a framework needs to be outlined where a paying patient can get the desired product even as poor patients are supported by government schemes and subsidies.

In a private hospital, the paying patient helps subsidise treatment for someone who cannot afford it, he says. Patients are asking questions on the quality of the product they are receiving, fearing that scientifically established products may not be in the market, says Shetty, founder of the Narayana Health chain of hospitals.

An industry source explains that the fear of supply shortages stems from the fact that companies will not be able to justify higher prices in other markets, if they sell the same product at reduced prices in India. This could lead them to exit from unviable markets and head to places with more realistic prices.

The National Pharmaceutical Pricing Authority (NPPA) maintains that no supply shortage has been reported in the country.

Putting the onus on the medical devices industry, Shetty says the Government did try for an amenable solution. It’s time to start afresh and price the products right, he tells industry, pointing to the damning data revealed by the NPPA that showed cardiac stents with landing cost at ₹20,000-odd being sold to patients at over ₹80,000.

“Everybody’s at fault,” says Shetty, urging industry to get realistic on prices, incorporating a legitimate margins as allowed by the Government. NPPA’s data revealed up to 1,000 per cent distribution margins along the supply chain on cardiac stents. On margins, the industry stretched it too far, agrees Shetty.

The Government now needs to instil confidence in patients that products available here are supported by rigorous testing and regulatory approvals. In the US, for example, quality and price are kept in check between the regulator and insurance companies. Patients will not pay if a product has a bad scientific track-record, he points out.

With the price-control sword hanging over other medical products, Kaushal Malhan, a knee and hip surgeon with Fortis Hospital, says that his decision-making is guided by pathology, not cost. The product needs to have a clinical track-record with enough data supporting it and it should be suited to the medical condition of the patient, he explains.

Arun Mitra of the Indian Doctors for Peace and Development (IDPD) calls for financial and medical audits to establish if a procedure was done for the right reason and had the desired outcome. IDPD is part of the Alliance of Doctors for Ethical Healthcare that has been calling for greater price control on devices and standardisation of treatment guidelines.

The alliance has urged the NPPA to monitor the price of other ancillary products and hospital procedures that could get inflated now that stent prices are capped.

With the scientific superiority of medical devices and the prices they command being moot to the price control discussion, the Government now needs to call for an independently funded study possibly by the ICMR (Indian Council of Medical Research) to compare different products and map their safety record.

In the absence of such studies, the discussion will continue to be influenced by emotion or lobbies rather than scientific reasoning. And this could hurt product quality, supply and most important, the patient.

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