News
Health sector corruption now on T-20 scale
View(s):- Pharmaceutical industry officials say bypassing NMRA, waivers of registration, emergency purchases increasingly being normalised
By Namini Wijedasa
Corruption in medical procurements is a longstanding problem but the growing practice of buying drugs bypassing national regulatory oversight has thrown open the floodgates, senior pharmaceutical industry officials warned this week.
One private sector official used a cricket analogy to illustrate just how serious the status quo is. Back then, he said, it was like a Test match. Then it became a 50-over game. Now, it’s a twenty20.
As the health sector ails due to corruption, and drug prices soar, most people have no option but to visit State hospitals to receive treatment
“If a five-day Test match is equivalent to five years, you take your time and play,” he explained. “And whenever there’s a loose ball, you hammer. Even with a 50-over game, you could stretch it out. But with a twenty-20, there are a limited number of balls. And each and every ball, you try
to score.”
Unending Emergencies
Waivers of registration (WoRs)–whereby the National Medicines Regulatory Authority (NMRA) complies with direct Health Ministry orders to green light drugs and appliances without legally mandated checks, procedures and local registration — are more common than ever before.
The law is specific about WoRs. The NMRA Act states that the Authority “may” grant permission in “special circumstances” to import and supply a particular pharmaceutical product in specified quantities without registration. These include a medicine used to save a life, to control an outbreak of an infection or an epidemic or any other national emergency or for national security.
The law does not authorise the use of WoRs in “emergencies” arising from inefficiency, corruption and the willful erosion of recommended procurement procedures. WoRs mean that neither the suppliers nor their products are independently vetted. There is no oversight apart from a basic document check.
The onus for accountability and management of a product imported under a WoR falls on the importer. But the very proliferation of WoRs and attendant quality issues does not bode well for the pharmaceutical sector, as a whole. The industry says only “complete transparency” in tender procurement will set things right.
None of those interviewed wished to be quoted as they were required to remain in business in Sri Lanka (for which they must continue to deal with Government entities). One of their key recommendations is that medical procurement must be done through one unit–and that all tenders should be advertised on a single platform.
“At present, the State Pharmaceutical Corporation (SPC), the Health Ministry’s Medical Supplies Division (MSD) and the State Ministry of Pharmaceutical Production, Supply and Regulation do purchasing,” said a longtime industry player. “There are also procurements under the Asian Developing Bank-funded Health Sector Enhancement Project, among others.”
Digital, Digital, Digital
“We need a single platform accompanied by clear tender procedures,” he stressed. “It must be simplified and people must be encouraged to bid.” And the process must start with proper planning by the MSD.
“They should draw up annual estimates but their planning is always wrong, or wonky,” another official said. “That is one reason you get these emergency purchases. Everybody knows there are a lot of malpractices.”
“Why does this emergency keep arising?” he asked. “Why is there a deliberate attempt to preserve it? Because that’s where the money is–it’s not a secret anymore. Everyone knows.”
Over the past year, “people with good intentions” have been meeting in different forums and making recommendations. There is consensus that the best way is by “going digital”. But there is strong resistance, mostly internally among those who benefit from the status quo.
For instance, a digital system for registering drugs was introduced at NMRA but it went defunct after the entire database was mysteriously wiped out. There was no backup. Even the investigation is at a standstill.
A medical supply management system (MSMIS) was established in 2015 to cover 82 institutions including MSD, the SPC, the NMRA and Health Ministry hospitals. It was extended to base hospitals for ordering, distribution and stock management. And it also facilitates stock receipts and annual inventory surveys. But the National Audit Office found that the system has neither been updated nor used adequately.
“We all have to push for digital, digital, digital,” said a third pharma industry source. “We need transparency. That’s the only way to minimise corruption.” At present, there is no system even to swap medicines between hospitals when one needs more than another of a particular product. And sometimes, purchases are made of stocks that are already available in sufficient quantities. Expiries are common.
Big companies not bidding
The pharma industry also believes all colleges of specialties should be included in procurement decisions. The Sri Lanka Medical Association is already compiling a wish list of essential medicines. This, too, must be
digitalised.
The sources the Sunday Times interviewed pointed out that “big companies” had a tendency not to participate in tenders for multiple reasons. One was that the tender guidelines favoured the buyer, not the seller. The other was that payments are not made on time–sometimes taking up to 360 days to be disbursed.
“We have been recommending that the Ministry does an age analysis on which basis they can systematically make the payments,” one of the sources said. “Start with those companies that have been waiting the longest. These are simple things.”
But everything, they say, falls on deaf ears. And people lose interest. When registered, credible players back off, in a situation where the country needs medical supplies, the unregistered suppliers step in and WoRs become routine.
The solution is to plug the holes so that reputed companies feel encouraged–and facilitated–to supply drugs. The opposite is happening. Even the number of brands that are allowed to register for each molecule (as they are called) has been restricted on the excuse that the NMRA does not have enough staff to process all the applications.
“When you reduce the number, you create a monopoly,” one senior official said. “They keep saying they will recruit more staff. But there is no pharmacologist right now in the NMRA. Or you have a pharmacologist who doesn’t know anything about market dynamics.”
Yet another problem
There is now a new problem. President Ranil Wickremesinghe recently held a meeting with officials on the subject of medical procurements. According to his office, he instructed the Health Ministry to expedite the approval process for drugs endorsed by the FDA [US Federal Drug Administration] and other countries. Additionally, he called for amendments to the NMRA Act to enable swift action and overcome obstacles in drug procurement.
“Why can’t you ask the FDA and approved drugs, UK approved drugs, has it got to go through the NMRA or can you just order it?” he is reported as saying. “So that is a question. In fact, that is a matter in courts at the moment. So I have asked the NMRA to go ahead now and immediately approve FDA drugs and the other countries which have agreed with the Health Ministry, and the Health Ministry will then bring amendments to the NMRA Act which will enable them to act quickly and overcome all the difficulties.”
According to the pharmaceutical industry, it is not that simple. Approvals are based on temperature and humidity. The USA, Britain, etc, are “Zone 2” countries while Sri Lanka is “Zone 4B”.
“Drug stability there and drug stability here are two different things,” one of the sources said. “That is why these companies often spend a lot of money to make the stability of the product suitable to our humidity and temperature. What is registered there can’t be brought here. That is one simple parameter.”
And in an environment where corruption and bid-rigging are rife (and not a secret), this type of blanket approval process could create more problems than it solves.
“Sure, if a company has FDA registration, you need not be too stringent because the US regulator is very tough,” another source said. “Any company who has US FDA won’t cheat on their ethics and compliance. Perhaps you can be lenient and give them fast-track registration.”
“But you need to double-check,” he insisted. “Say an Indian company claims its product is registered in the US. They may bring a forged document to the NMRA to prove it. How will our people check the authenticity of the document? Registration will be given as recommended by the President. This will again open the floodgates.”
“Also, a manufacturer might have three factories,” he said. “One may be registered in the US and the other two might not be. Again, within one vicinity, there could be sites A, B and C. One may be FDA approved and the others not.”
The President’s instructions should also be accompanied by proper guidelines for the issuance of such approvals, the sources unanimously said.
The best way to say that you found the home of your dreams is by finding it on Hitad.lk. We have listings for apartments for sale or rent in Sri Lanka, no matter what locale you're looking for! Whether you live in Colombo, Galle, Kandy, Matara, Jaffna and more - we've got them all!