In the implementation of government schemes providing cochlear implants for children with profound hearing disabilities, profits trump the interests of patients.
The rapid rise of medical science in the modern era has been based on the premise of sharing its benefits for human collectivity. However, both science and public health take a beating when access to health technologies is curbed for profits. Unfortunately, in the implementation of the central and state government programs providing cochlear implants for children born with profound hearing disabilities, we see ripe examples of how profits trump patients’ interests.
According to the National Sample Survey (NSS) 58th round (2002), hearing disability was the biggest cause of sensory deficit and the second most common cause of disability. In India, 63 million people suffer from significant hearing loss. Four in every 1000 children suffer from severe to profound hearing loss and over 1,00,000 children are born with hearing deficiency each year. Cochlear implants offers an effective remedy to those suffering from profound sensorineural deafness. Even though nearly 1,00,000 Indian children need cochlear implants each year, only around 4000 children undergo the procedure.
There are two main reasons for this huge unmet demand. First, the exorbitant cost of cochlear implants and the procedure makes it unaffordable for most people. Second, the cartelised arrangement between cochlear implants manufacturers and a group of ENT surgeons prevents the scaling up of the procedure.
Currently, only three foreign companies are marketing cochlear implants in India, Cochlear (Australia), Med-el (Austria), Advanced Bionic (USA) and new entrant Oticon (France). In the absence of domestic manufactures, both the government and the people are at the mercy of these foreign companies. Though the Defence Research and Development Organisation (DRDO) is developing an indigenous cochlear implant, in keeping with the vision of former President A.P.J. Abdul Kalam, it would take some time to enter the market if everything goes well.
The printed maximum retail price (MRP) of cochlear implants’ base model is about Rs 5,00,000, which is higher than the price at which it is imported, by a margin of Rs 73,000 to Rs 1,78,000 (see table for details). Since the retail prices of cochlear implants are not available in the public domain, doctors and hospitals tack on additional handling charges that can vary from 5-50% of the MRP. As a result, the cost of a cochlear implants procedure is in the range of Rs 8,00,000 to Rs 12,00,000, which includes the price of the implant, hospitalisation, surgical fee, post-operative care and audio-verbal therapy (AVT).
|S.No||Cochlear Implant||Company||Country of origin||Market share||Landed cost||Maximum Retail Price||Markup from landed cost|
|1||Nucleus Freedom||Cochlear Medical Devices India ltd.,||Australia||50%||4,58,940||5,32,000||73,060|
|2||Sonata TI 100||Med-el India Ltd.,||Austria||30%||3,53,500||5,32,000||1,78,500|
|3||HIRES-1J HR90K ADVANTAGE
|Advanced Bionic India Pvt., Ltd.,||Advanced Bionic||18%||3,85,095
The artificially inflated price of cochlear implants includes hefty commissions for doctors/hospitals. Further, doctors are offered one free cochlear implants for every five to ten cochlear implants purchased. Companies also sponsor the doctors’ participation in various conferences.
The cartelisation is legitimised through an association called Cochlear Implant Group of India (CIGI), which was created with the objective of progress in cochlear science. However, the organisation imposed restrictive clauses through the unscientific ‘recommended clinical guidelines for cochlear implant’ to prevent the growth of the science. These guidelines insist that ENT surgeons can carry out cochlear implants only after going through a “mentorship”. Since there are no training programs in medical schools for cochlear implants procedure, ENT surgeons are at the mercy of the CIGI for mentorship and often pay hefty fees. Only about 20 of 460 medical colleges carry out cochlear implant procedures in India. Manufactures often refuse to provide implants to ENT surgeons capable of carrying out cochlear implants who have not undergone the mentorship program of CIGI.
To address the unmet demand due to unaffordability, the central government and seven state governments introduced free cochlear implants programs. The prices of cochlear implants came down from Rs 6.5 lakh to Rs 3.8 lakh through procurement under the Assistance to Disabled Persons for Purchase/Fitting of Aids and Appliances (ADIP) scheme under the Ministry of Social Justice and Empowerment. However, experts in the government committees, who are often affiliated to CIGI, succeeded in imposing several unscientific and restrictive clauses to exclude the other surgeons from participating in the scheme. For example, ADIP and the Karnataka government cochlear implants scheme stipulates that the surgeon must have performed a minimum of 25 independent surgeries. Kerala’s Shruthi Tharangam scheme demands a minimum of ten independent surgeries with implants approved by the US Food and Drug Administration (USFDA). An even higher standard is imposed by the Tamil Nadu cochlear implants scheme, which stipulates a minimum of as many as 100 surgeries with USFDA approved implants. The Andhra Pradesh cochlear implants scheme demands an expensive surgical set-up with equipment that is unnecessary for such surgery. Most of the cochlear implants schemes favour private hospitals and surgeons, and provide an additional surgical fee of Rs 60,000 to them. Most of the medical colleges are deprived of the scheme where these surgeries could have been performed free of cost or at a discounted price. All government schemes support post-operative rehabilitation know as AVT and pay an amount of Rs 40,000 to Rs 1.3 lakh to empaneled private hospitals and doctors. However, barring the ADIP scheme, most of the state programmes are reportedly performing sub-optimal therapy with sessions limited to only one year when much more is needed for rehabilitation of children. In addition, most of the children drop out of the AVT as it is beyond the means of their families to stay for extensive periods in metro cities for the rehabilitative therapy and also to buy necessary accessories for the cochlear implants. Private establishments are raking in huge profits through the AVT with minimal investment in infrastructure and the AVT personnel.
There is an urgent need for both the central and the state governments to take measures to ensure access to free or affordable cochlear implants. First, is to break the cartel and initiate actions against manufacturers and CIGI under the Competition Act. Second, is to revamp the guidelines to scale up cochlear implants procedure in a holistic way where more stress is placed for universal newborn hearing screening, early identification and hearing aid fitting, and establish easily accessible community-based rehabilitation centres. Third, is to expedite the commercialisation of indigenously developed cochlear implants. Fourth, is to start a national cochlear implants registry to monitor such cases and to study clinical outcomes. Fifth, is to cap the retail price of cochlear implants. The constitutional provisions and international treaties, including UN’s Convention on the Rights of Persons with Disabilities, creates a legal obligation on the government to act expeditiously. The current scenario regarding cochlear implants is extraordinary bleak, combining as it does anti-competitive behaviour and the egregious violation of medical ethics. It destroys the future of lakhs of children, consigning them to a life of disability and severely limiting their future possibilities.
Prahlada N.B is professor and head of the Department of Otorhinolaryngology, Basaveshwara Medical College and Hospital, Chitradurga, and is associated with the All India Drug Action Network.