REGULATION of healthcare has become a burning issue in Pakistan, especially with advances in medical technology and medical procedures. Weak regulations have resulted in many a scandal in this sector. The possibilities of unethical moneymaking are especially plentiful where common life-threatening conditions such as heart disease are concerned. The recent stents scam is a case in point.
A stent is a tubular, expandable device inserted into coronary arteries to remove blockages, extend life span and improve the quality of life for heart patients. The stents industry has grown enormously ever since the US Food and Drug Administration endorsed the use of the device in 1994. In Pakistan too, the stents market has expanded with the growing burden of heart disease in the country.
This has opened up avenues for commercial gains both for medical professionals as well as the pharmaceutical industry at the expense of patients. Though public memory is short, who can forget the Punjab Institute of Cardiology scandal where the administration of substandard medicine led to the death of more than 200 people?
Like much else in Pakistan, the crime was buried deep in official files with no action instituted against the culprits. It is no surprise therefore that now, in the continuing absence of regulation, a stents scam has surfaced. It was exposed in the media when substandard stents were found in huge quantities in a major hospital in Lahore.
Further media inquiries uncovered several disturbing practices in the stent implant market as well as several regulatory and ethical issues related to it. One, the market is awash with unregistered and substandard stents. Two, the cheap stents are often implanted not for medical reasons but for purely commercial ones and the patients end up paying for unnecessarily implanted stents. Three, very often patients are made to believe the required stent placement was carried out and they are charged the cost of implantation while in fact the stent was not implanted. Four, stents are sold at astronomically higher prices than in the price-controlled and regulated market in the West. For example, as per media reports, Indian stents which range in price between Rs13,000 to Rs26,000, are sold between Rs200,000 and Rs300,000 in Pakistan carrying fake labels. Five, not only is there a discernable lack of regulation, but there is no enforcement of even the existing threadbare regulatory regime.
In response to the media exposure of the unethical practices surrounding stent implantation, the Supreme Court has taken suo moto notice of the issue. The Senate has also issued directions to the Drug Regulatory Authority of Pakistan (Drap) to frame a pricing policy within a month. The pharma and medical technology industry, with a huge commercial stake in the issue, has used the negative publicity to push for speedy registration. While the SC and Senate have acted swiftly, Drap, which has said it only approves the stents already proved by robust regulatory bodies in the West, has admitted to a lack of expertise to speed up the registration process. Nevertheless, in the face of pressure from the industry, it has duly expedited the process. This raises serious safety concerns for patients, given Drap’s admitted lack of expertise to vet the new stents. The overwhelming media focus on registration has also taken the focus away from unethical practices around unnecessary and overpriced implantation of stents in heart patients.
The stent scam has highlighted several flaws in the stent implantation market. The foremost of course is the lack of robust regulation. Active vigilance and robust regulation of the market is urgently needed, given the vast scope in the present situation for unethical practices to flourish which pose grave risks to patient safety.
Drap has so far not lived up to its promise as evidenced in a blizzard of negative stories about its role and competence since it was set up in 2012. With the regulation of drugs and medical devices developing into a highly technical field, Drap should rethink its role in the new landscape. It is vital therefore that the authority equip itself with the right kind of workforce and put in place transparent decision-making processes. While drawing on the expertise of those who have the relevant capacity and experience, Drap would also do well to involve wider civil society groups in its decision-making processes and make its decisions public on its website. Furthermore, robust enforcement of regulations is as important as the need to rethink the Drugs Act, 1976 which must be updated and implemented in letter and spirit. Above all, the cost of treatment for heart patients has to be lowered with the patients fully informed of the cost and side effects of stents.
The writer is a consultant and policy analyst.
Published in Dawn, March 28th, 2017