A large number of health groups and doctors advocating for ethical healthcare have sought urgent intervention of Union government to end the nexus between hospitals, doctors and the industry that is resulting in exorbitant prices of life-saving coronary stents. They have also demanded to the government to immediately implement a legally binding code for marketing of all health products including medical devices like coronary stents in the country.

These groups also demanded to the government that price fixation of coronary stents should be limited to two categories – Bare Metal Stents and Drug Eluting Stents – as instructed by the Department of Pharmaceuticals (DoP) in its notification dated 21 December 2016. The ceiling prices fixed by the NPPA must meet the objective of ensuring true affordability and should be fixed on the basis of the CGHS reimbursement rates.  The government should act in the public interest and uphold fundamental right of right to health and not succumb to pressure from the industry or the medical establishment, the health groups said.

The health groups further demanded that the government should develop standard treatment guidelines for cardiovascular interventions with the help expert doctors free from conflict of interest and implement medical audits of procedures.  The Medical Council of India (MCI) should investigate the professional misconduct of doctors, particularly the office-bearers of the Cardiological Society of India that have indulged in unethical lobbying, they said.

All India Drug Action Network (AIDAN), Alliance of Doctors for Ethical Healthcare, Third World Network, Jan Swasthya Abhiyan and the National Working Group on Patent Laws are some of the groups which have made these demands to the government.

“We have consistently highlighted the unconscionable prices that patients across the country are paying for stents that are pushing patients and their families into increasing indebtedness or leaving them without life-saving treatment,” said Dr. Mira Shiva of AIDAN. “The pricing data which was submitted by the industry to the NPPA has made it clear beyond doubt,” she said.

The analyses of industry data published by the NPPA on its website, which show the massive margins charged at each step in the distribution and supply of stents. The data indicates that by the time the patient gets the stent, the increase from the original cost of the stent is often in the range of 1,000-2,000 per cent.

“With the evidence of over-pricing now crystal clear, the government must act immediately to control the prices of these life saving devices” said Advocate Birender Sangwan.

The inclusion of coronary stents in the NLEM, which prompted the current efforts by the NPPA towards price fixation, arose from a petition filed before the Delhi High Court by Advocate Sangwan. In a second petition, also filed by Sangwan, which is pending before the same court, the Government has been directed to make a report to the Court after the ceiling prices have been notified. Even as the NPPA is examining different formulas to fix an affordable price for stents, industry lobbying to thwart these efforts appears to have increased in recent weeks.

“Reports indicate that companies and industry associations are lobbying intensely for a ceiling price based on a simple average of hospital prices which will ensure that the profiteering continues unabated and hospitals can take huge cuts on the stents. There is an urgent need to fix the price at an affordable price that does not expose people to the exploitation of hospitals and stent manufacturers,” said Malini Aisola of AIDAN.

There are also attempts, primarily by foreign companies and cardiologists acting on their behalf, to exclude from price control the highest priced stents, which also happen to dominate the market.  “The industry is making unsubstantiated claims of superiority of the newer model stents such as bioreabsorbable stents,” said Dr. Dinesh Abrol from the National Working Group on Patent Laws.

“This is a ploy, in conspiracy with the hospitals, to charge ungodly sums of money for minor changes to existing products in order to exploit patients. We have seen the same tactic employed by multinational companies where they claim extended patent monopolies on minor, often frivolous changes to old medicines to charge high prices. This is the medical devices equivalent of evergreening of patents and these arguments must be squarely rejected by the NPPA and the government in fixing the prices of stents.”

The NPPA data also shows that the largest cut goes to the hospital, which can be as high as 650 per cent more than the price at which the hospital purchases the stents from the distributor.  “We are extremely alarmed at the role that doctors and hospitals are playing in the exorbitant pricing of stents,” said Dr. Arun Mitra of the Alliance Of Doctors For Ethical Healthcare (ADEH).