Donation or drug dumping: New scandal rocks health sector
Unsolicited and not-used-in-Sri Lanka medicines enter the system; NMRA issues waivers and tax-relief requests; WHO guidelines ignored Questions over whether big pharmaceutical companies are sending short-expiry drugs for incineration here
Fresh off the health sector medicines procurement scandal--which culminated in the administration of counterfeit human immunoglobulin to patients--questions are being raised about the vast quantities of recent drug donations that flowed into the country.
How many of these drugs were listed as “necessary” or “in use” in the Sri Lankan health sector? How many were short-expiry? How many were forced to be destroyed because the Medical Supplies Division (MSD) delayed in clearing them and they expired; or they were not needed here; or they were so close to expiring that they went out of use fast?
And were pharma companies abroad dumping their short-expiry drugs on Sri Lanka to earn tax breaks and escape the cost of disposing of them at home?
Influx of unnecessary drugs
Sri Lanka’s health service was supported generously by many local and international organisations during COVID, senior doctors pointed out. Drugs, equipment and reagents for tests were received in this manner. While many were not registered in Sri Lanka, they were monitored by the National Medicines Regulatory Authority (NMRA), ensuring that many unnecessary drugs and devices were prevented from entering the country.
The NMRA proactively published criteria for accepting donations, followed by a quick evaluation by an expert committee. Only drugs required by the local health sector were allowed to be imported on waivers of registration (WoRs).
The same method was adopted to deal with a drug shortage early last year: A list of required drugs was provided by the MSD and the NMRA only allowed those to be imported.
In June 2022, former Health Minister Keheliya Rambukwella sacked the NMRA Board and reappointed just a part of it. Its members changed the method of accepting donations. Drugs and devices were allowed to be imported on WoRs issued by the new Chief Executive Officer, whenever requested by the Health Ministry. There was no evaluation, said health sector sources.
This, they insist, has led to an exodus of expired drugs and unwanted drugs. For instance, the MSD’s official website shows 129,600 tablets of the combination product of olmesartan medoxomil 20mg, amlodipine 5mg, hydrochlorothiazide 12.5mg are available.
“This drug is not used in our country and therefore will have to be disposed of,” a senior medic said. There are also 33,000 tablets of a combination product of paracetamol 500mg+ phenylephrine hydrochloride 10mg+ chlorphenamine maleate 2mg. This drug, too, is not used in Sri Lanka.”
The modus operandi
Documents show that, on May 5, NMRA CEO Vjith Gunasekara issued a WoR for a consignment of drugs from the United States. On May 17, Health Secretary Janaka Sri Chandragupta wrote to the Director General of Sri Lanka Customs requesting a waiver of the Special Commodity levy, PAL and VAT for the same consignment. The reason he gave was that the shipment contained essential medicines.
Invoices for this shipment reveal that some of the drugs--for example atorvastatin, acyclovir, levetiracetam and lidocaine topical application--had already expired by the time the NMRA CEO and Health Secretary issued these letters.
Several other drugs in the consignment, such as leflunomide, bupropion and galantamine, were to expire by June 30, 2023. Galantamine, canagliflozin and some other medications in the cargo were not used in Sri Lanka.
Who pays for disposal?
“This means that all of these drugs will have to be disposed of using public funds,” the medic pointed out. “And it was for such drugs that the NMRA CEO and Health Secretary requested waivers, claiming they were essential medicines.”
The destruction of expired or unwanted medicinal drugs is not cheap, especially in developed nations. In Sri Lanka, many such products are sent to a private company for incineration, at a cost. Questions are being asked whether Sri Lankan authorities allowed the country to become a dumping ground.
“The shipment in question appears to have been sent without consultation and the Health Ministry has accepted the donations without any questions,” a senior clinical pharmacologist said. He did not wish to be named. “In the end, it may result in the MSD having to pay more than the medicines to dispose of unsuitable drugs.”
This pharmacologist, too, analysed the drugs in the US shipment. He said they were a mixture of medicines used in Sri Lanka (like omeprazole, lidocaine, atorvastatin, timolol eye drops, acyclovir and antenatal vitamins).
Others were not commonly used like canagliflozin (third-line anti-diabetic), leflunomide (for rheumatoid arthritis) and bupropion (antidepressant). Doctors were not familiar with them. A drug like galantamine “is of very poor efficacy for confusion in dementia”, he said.
Tax breaks for manufacturer?
The question was whether this shipment-which was valued at a massive US$ 37mn in the Health Secretary’s letter (a copy of which was seen by the Sunday Times)--was issued to Sri Lankan hospitals in time, as most medications had short expiry dates.
“The prices of these medicines in the donation are the USA prices, the highest in the world,” he pointed out. “These should not be taken at face value. I would think that Sri Lanka could import these medicines at around 10% of the invoice from India.”
Some of the drugs are very close to expiry, he continued. “Clearly there has been dumping of medicines close to expiry,” he said. “This could be by the manufacturers. What is the advantage for them? Donations are a tax write-off, so they can decrease their taxes. This is a very common trick by pharma companies.”
These drugs arrived in Sri Lanka despite WHO guidelines specifying that there should at least be one year of shelf life. The majority has only a few months and will need to be destroyed a few weeks after arrival. “It could be that the pharma manufacturer not only got a tax break, it did not need to bear the cost of disposing of the drugs,” the pharmacologist pointed out.
“Note that the WHO Donation Guidelines say the recipient should agree to the drugs that will be donated,” he said. “Was there any discussion or the drugs were simply sent? Did the relevant foreign donor have any correspondence with the Health Ministry or they simply send the drugs and the Health Ministry accepted them?”
Sri Lanka’s health service was supported generously by many local and international organisations during COVID, senior doctors pointed out. Drugs, equipment and reagents for tests were received in this manner. While many were not registered in Sri Lanka, they were monitored by the National Medicines Regulatory Authority (NMRA), ensuring that many unnecessary drugs and devices were prevented from entering the country.
Highly irregular
The waiver of registration granted for the shipment is also, uncharacteristically, for multiple products-- not individual medications, as mandated. This was deemed “highly irregular” by medical sources.
“In some of the Invoices there is no manufacturer of the drugs mentioned, so we do not know where the medicine is coming from,” one said. “And drug donations at any time, especially during a crisis or emergency, should be discussed beforehand to be suited to the purpose of the healthcare system.”
“There is a long history of abuse of the drug donation process by those who benefitted from donating and those who received the donations where the problems outweighed the benefits,” he concluded.