Prashant K Singh, Director, Coordination and Strategy Development, at the Public Health Foundation of India. expounds on how faulty devices are both a market and moral failure. Only stringent regulations can constrain the callous behaviour of actors in the chain
‘A man without ethics is a wild beast’, said Albert Camus, the famous French philosopher. But a web of organisations without ethics is monstrosity infinite. The recent revelation about faulty medical devices, adversely affecting hundreds and thousands of lives, rich and poor alike, from developed to developing countries, exemplifies an entire value chain operating with impunity and without moral scruples.
The medical device industry, manufactures a range of products: hi-tech surgical instruments to insulin pens, knee and hip implants to cardiac stents, hearing aids to pacemakers, syringes to surgical gloves, globally worth $400 billion. In India, the medical device market valued between $ 5-6 billion may be a fraction of the global market, but it is growing fast. With 75 per cent imports, it is dominated by the MNCs. Sitting at the apex, the industry with market power, leads and controls the numerous actors and activities in the entire global value chain: R&D, manufacturing, assembly, distribution, marketing and sales, training of doctors, after-sales service.
It is a big business and run like one. Excluding many diagnostic and therapeutic devices, the patient chooses from around 150 types of knee implants, four types of total hip replacement devices, five types of drug-eluting stents and three different types of pacemakers, multiple models of hearing aids, each with a different life, price and features. Talk about informed choice. Recall the dilemma while standing in a grocery aisle in the supermarket, coffee shop or an ice cream parlour. With high information asymmetry, the patient as a customer can exercise such a choice only with the assistance of a clinician, placing inherent trust in the clinician, hoping the advice is without any ulterior motive. Informed decision making in the best of times is a challenge, and more so when consequences can be fatal.
Running a profitable business is fine, but not when it sacrifices ethics and morals, not when it disregards dignity of individuals, not when it reverses “first, do no harm” and not when it forgets “patient first”. And with around 55 lakh adverse events worldwide in the last 10 years, the entire value chain seems to be running amok in lure of the lucre. Consider that a hip implant, was recalled globally but patients in India were not informed promptly. A birth control implant malfunctioned, causing serious health problems in women in the US and Australia. No wonder, innumerable patients queue up for revision surgeries across the world, suffering additional cost, risk and misery.
During last year alone, US FDA recalled 32 devices, not to mention another 32 it recalled in 2017 and 39 in 2016. These recalls indicate either a cavalier attitude to quality during manufacture or laxity in clinical trials that approved the devices or both. In comparison, carmakers have had fewer recalls across the globe. A medical device is not just any other value-added commodity; if faulty, it affects the quality of life, even snuffing out an unlucky one.
A recent Netflix documentary ‘The Bleeding Edge’ highlighted the inexact process by which FDA grants approvals to medical devices. Elsewhere and in the US adverse events happened owing to lenient regulation. Unlike pharmaceuticals, the regulatory barrier for accessing the market is much lower for medical devices. Regulating these devices is fraught with complexity: There are no uniform standards worldwide as the global regulatory harmonisation is a work in progress; FDA in the US may approve a device after a randomised controlled trial, whereas the EU may accord market approval to the same device only by an observational study. While introducing a new or modified version, a manufacturer may claim substantial equivalence to an already existing device without collecting fresh clinical data. Lifecycles are short; innovations are frequent. Post-market introduction, the performance also depends upon the skill level and the learning curve of the doctor in using the device.
Only a year ago, India passed the Medical Device Rules, 2017, effective from 1st January 2018, classifying devices into A,B,C and D, from low risk to high risk; however, they are still considered as drugs under the Drugs and Cosmetics Act, 1940 and a separate Act is yet to be passed. But in countries like India, the patients face a double whammy, both on account of cost and quality. The trade margins have been exorbitant, even up to 300 per cent. When the government, which is duty bound to make health care affordable to all, put price ceiling to cut down rampant profiteering, the cost of devices came down but not the total cost of the procedures. The markets are not free and far from perfect. However, as much as a market failure, it is a collective moral failure.
As technological innovation progresses, medical devices would be used in each stage of health care —primary, secondary and tertiary—alongside changing the pattern of care. Therefore, nations have to frame and tighten regulations, especially for high and medium risk devices, ensuring acceptance after rigorous evidence. Many in the industry argue that this would increase costs, stifle innovation, dissuade investment in R&D and introduction of newer technology. But, no industry in the world, be it airline, automobile or food industry, barters safety and effectiveness for other considerations.
As greed trumps ethics, each member of the value chain is maximising its profit with callousness; this beastly instinct can only be tamed with regulation. But, if regulations are lax, the wild beast shall prevail.