Deleted data

In recent months, the National Medicine Regulatory Authority (NMRA) has been in the news, particularly because of missing data. As the Sunday Times?reported?in August, terabytes of data disappeared from the Lanka Government Cloud, where?government data?is stored.?

The NMRA?is?a recently established authority, set up in 2015 to ensure that medicinal products in the country meet standards of quality, safety and efficacy - this includes medicine and medical devices, clinical trials, cosmetics and ‘borderline products’. In this instance, what went missing?was?data from applications for registration or licensing of medication through a new digital system recently introduced by the NMRA. Subsequent investigation?revealed?that only four engineers from IT firm Epic Lanka had access to the database, and that the files had been deleted. While a historical snapshot of the data?has?been recovered, the original files have not.?The digital system was introduced to make it easier for tracking NMRA’s approval process - and to prevent money changing hands to ‘expedite’ registration for certain drugs, the Sunday Times?reported.?

Ordinarily, this story would not have received the attention that it did, but during a pandemic, when the ready supply of potentially life-saving medicine is crucial, it’s not surprising that it led to discussion. The question of what data was missing was raised in Parliament, with State Minister Channa Jayasumana saying that?5925?files had been erased, adding that none of them pertained to COVID-19 vaccines, medicine or devices. The State Minister didn’t miss an opportunity to hit out at the opposition, charging that much of the deleted data was on medicines which had been imported at exceptionally high prices - as many as 40 varieties, according to a list tabled in Parliament.?

However in a returning salvo, SJB MP Harin Fernando?revealed?that the data deleted included medical licenses, sample import licenses and approvals for medicine from foreign manufacturing sites. The police have?also?said the lost records include drug formulas, and alleged that the system records showing who accessed the data had also been deleted.?

The CID is now conducting investigations, while the CEO of Epic Lanka?was?arrested and produced in court. There are differing accounts on whether the data was deliberately deleted or whether it was simple negligence (one point of negligence is certainly that there appeared to be?no?backups of the data, which would indicate protocol failure on the part of the IT company - designing a system for backup was also?reportedly?part of the contract).

But perhaps this story is about more than securing confidential data.?

Bypassing due process

Shortly after the story of missing data made headlines, the NMRA made news again for?failing?to grant registration to lower cost Rapid Antigen Test kits. 36 companies submitted quotations in the tender process, out of which 2 products were selected. However, rival bidders and the President of the College of Medical Laboratory Sciences of Sri Lanka were quick to raise questions on the process, noting that several bidders had not been granted import licenses to bring down samples, with the tender document specifically noting that samples weren’t necessary for the tender process - with some of the bidders samples being rejected over others. What’s more, the SPC had given just?six?days for quotations to be submitted.?11?of the bids quoted lower prices than the winning bidder, George Steuarts Health (pvt) Limited.?

This story of tender processes favouring certain suppliers or otherwise bypassing due process is familiar, and has been seen for a?number?of?sectors?and across?successive?governments.?

However, Sri Lanka is in need for test kits for COVID-19 (although it appears to not be pursuing aggressive testing as a containment strategy - as of 19 September,?9837 PCR tests and 3525 RAT tests?were carried out according to the Health Promotion Bureau despite the continued spread of the Delta variant.) While?falling case numbers and hospitalisation?have been reported, experts have also?criticised?the low testing rates in the past.?

Scarcity

The result of this scarcity of tests meant higher prices - a month ago, a PCR test could?cost?anywhere from Rs. 5000 to Rs 9550 and an RAT from Rs. 2000 to Rs. 5900 across 45 hospitals. As a result, the government was forced to?implement?maximum price controls on testing after public complaints, which also focused on the favourable treatment given to George Steuarts. NMRA has also been in the news for lack of quality control for products like?pulse oximeters?(only?five brands?have NMRA approval, yet low-quality and even toy oximeters were being sold in the market at?high prices) and for struggling to meet demand for?face-masks?early in the pandemic. In each instance, this has led to price controls being imposed to prevent higher prices.?

Apart from these shortages of vital medical supplies, the drug?Ivermectin?was given a special waiver by the NMRA. This is deeply controversial as ivermectin is currently?not approved?as a drug that can be used to treat or prevent COVID-19 (it is?usually?used to treat parasites in livestock and humans). Yet, the belief that ivermectin can treat COVID-19 has been?fuelled?by right wing commentators in the US, a small group of doctors who are?diverging?from medical consensus, and by internet groups.

While ivermectin is currently in clinical trials to see if it could be effective to treat COVID-19, early research has?shown?that the amount of ivermectin that a person would need to take amounts to nearly 100 times the approved dosage for humans, and could lead to adverse impacts. Those who have been self-prescribing the drug in the US have increasingly ended up in?emergency departments?due to overdoses. This misinformation has now spread across continents,?including?to Sri Lanka, and it appears that the NMRA wanted to take advantage of anxiety about the Delta variant (and once again, George Steuarts?received?the waiver). Incidentally, during a Twitter space with regional epidemiologist Dinu Guruge, one of the listeners also asked about ivermectin as a treatment for an asymptomatic patient (ie. someone who has tested positive but is not displaying any symptoms of COVID-19) showing that the belief that ivermectin could be a treatment for COVID-19 is still spreading in Sri Lanka.?

The new digital system was supposed to solve corruption. While this is hardly a?new?problem in the health sector, the recent headlines raise questions about whether the NMRA is fulfilling its duty in allowing for the quality control of safe, approved medical supplies and medicine, at a crucial time for the country. While Parliament?debated?about whether the new eNMRA system was effective or not, what the story highlights is that technology alone won’t solve deep-seated issues like corruption.

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