The government's reported intent must be seen in the context of the criticism that it has received in the case of the Johnson & Johnson (J&J) ASR hip implant system recall and its aftermath
Recent news reports suggest that the Centre is taking steps to legally mandate that manufacturers and importers of faulty medical devices pay compensation to affected patients. While the intent to make compensation binding is understandable, a question mark still hangs over the ‘how and when’ of its implementation.
The government's reported intent must be seen in the context of the criticism that it has received in the case of the Johnson & Johnson (J&J) ASR hip implant system recall and its aftermath. The recalled hip implant accounted for a high number of revision surgeries causing patients unnecessary trauma at great cost, and as some have claimed, debilitating them for life. Several patients were reportedly either ignorant of a J&J programme to reimburse the costs of revision surgery or could not be traced. The drug regulator's office (that regulates devices too) and the Union Ministry of Health and Family Welfare are in the dock for their inability to prevent harm and their failure to ensure adequate compensation.
The government would want to be seen as having learnt from its mistakes and taking strong corrective measures. The issue of compensation suits the purpose rather well as that is also the focus of most media reportage and commentary. Business Standard reports that the issue of amending the Drugs & Cosmetics (D&C) Act to include a notification on compensation will be taken up by the Drugs Technical Advisory Board (DTAB), a body of experts that advises the Centre on technical matters. In the past, DTAB has taken up key issues impacting patient safety such as the review of drugs banned overseas but available in India, the rationality of fixed dose combinations, and the switching of drugs from prescription-only status to over-the-counter. Often, it set ups sub-committees for the purpose.
Over the years, the involvement of the DTAB has signaled that the Centre accords due importance to the matter under discussion. However, it does not necessarily suggest either urgency or a plan of action.
A notification requiring compensation will not achieve much unless there is clarity on every step of the process. Let me enumerate.
One, the trickiest issue — and one which is likely to be the first stumbling block — is determining what constitutes a faulty device or product and how. Remember that it was a voluntary, global recall that even brought the J&J case into the limelight and not complaints from either Indian doctors or consumers. There is also plenty of publicly available information on the ASR hip system, much of it from outside the country, because it was sold in markets which had more robust post-market safety and efficacy data collection. That need not always be the case. What happens when a product is suspected to be faulty but the manufacturer or distributor begs to differ and there is no data to prove it? It may be available only in India where post-market surveillance is weak. It may even be recalled without any admission of fault. (Even today, J&J's stance is that a recall does not necessarily imply that the product was faulty and that it continues to work well for several patients).
The success of certain devices such as implants is also determined by the expertise of the surgeon. A poorly-conducted procedure can lead to poor outcomes too. Initially, the need for revision surgeries in patients implanted with the ASR was attributed to incorrect surgical technique though we now know better. To arrive at a decision, expertise and infrastructure, such as government testing laboratories for instance, is a necessity. India's testing infrastructure in medical devices is a work in progress.
Two, which devices will it cover? The D&C Act only covers a sub-set of 'notified' medical devices. There are plenty more that are not regulated under any Act. What of them?
And finally, there is the issue of deciding the quantum of compensation which will, doubtless, see its share of debate. While the government has set up a panel to arrive at a formula in the J&J case, no awards have been granted yet. An actual award and J&J's reaction to it will be an indicator of the complexity involved.
All this will require a study inviting views from various stakeholders which, we all know, can be a long, drawn-out process.
Thus far, the government's reaction to the entire J&J controversy has been a string of defensive moves. First, it belatedly set up a committee to inquire into the issue, then virtually forgot about its report until it was flagged off in the media. It then hastily embraced the committee's recommendations of compensation without much thought to how, in the absence of any legislation, it could mandate compensation. Then, it set up another panel to work out a formula and recommended that each state set up its own to decide the quantum of compensation which put paid to any possibility of speedy compensation that patients might have hoped for.
Indeed, roping in the DTAB seems to be the most sensible decision it has taken so far; it suggests a longer view, and the desire to be better prepared the next time. But whether it will amount to anything — and by when — is another matter altogether.Gauri Kamath, a former business journalist, is a pharmaceutical and healthcare content writer. She tweets at @Apothecurry. Views are personal