The crisis surrounding Sri Lanka’s health sector was, until recently, viewed as a mere scarcity of medicines, medical equipment, and medical professionals. However, certain recent developments concerning the health sector – especially the procurement of medicines from foreign parties – suggests that the health sector crisis is way more complex, and is worsened by questionable acts that amount to irregularities and flaws.
Some revelations or allegations regarding such have created an environment where people have started doubting the extent to which they can rely on the country’s health sector.
The concerns about the importation of substandard medicines – which began with several medicine-related allergic reactions and deaths – were renewed this week with the National Medicines Regulatory Authority (NMRA) levelling explosive allegations about certain imported medicines. The Daily Morning yesterday (12) reported (citing the NMRA) that the local agent that imported the controversial batch of human intravenous immunoglobulin (IVIG) – which was recently withheld from use – allegedly submitting forged documents, had imported a batch of the rituximab injection, which is administered to cancer patients, using a similar forged document. According to what was revealed, the importer had presented a forged waiver of registration, claiming that it had been issued by the NMRA. The document shows that a total of 2,250 vials of the medicine had been ordered by the company in question.
The use of the drug in question at hospitals has been withheld with effect from Tuesday (10). However, that does not alleviate the threats that are likely to be posed by other medicines that may have been imported and/or distributed in this manner. And most importantly, this measure is not nearly adequate to prevent the importation of medicines in that manner in the future either. In other words, the health sector has identified an issue that is yet to be addressed. Making this situation a starting point, health authorities must launch an investigation – led by an independent committee unaffiliated with the NMRA – to look into this situation.
In addition to looking into specific companies, individuals, or documents that are involved, this investigation must look into how the said drug entered the country as well as hospitals. It is a general understanding that if Customs officials had checked with the NMRA when the said medicine reached Sri Lanka’s ports, the NMRA could, and should, have ascertained whether it had, in fact, received the NMRA’s approval. If that simple procedure took place, how did that medicine – which was imported using fake documents – enter the country? And if such a check did not take place, what were the reasons behind it? These are questions that need to be answered. More importantly, how a medicine that was imported using forged documents managed to enter hospitals – with or without having to go through the Health Ministry’s Medical Supply Division – is not a concern that Sri Lanka can put to rest unless a proper investigation reveals what actually happened. These investigations must be conducted in unison with experts – including the Government Analyst’s Department’s units specialised in fake documents – in order to be prepared to prevent the use of such forged documents in the future.
What is more, the practice of emergency purchases should be revisited, at least in the context of the health sector. Even though this is not a practice that is confined to the health sector, in this context, it is a matter of not only public funds, but public lives as well. Therefore, in the medium to long term, health authorities should look into amending the pertinent laws, regulations, policies, and practices in a bid to strengthen transparency, scrutiny, and accountability-related aspects of emergency purchases in the health sector. At the same time, while investigating the fake waiver of registration the importer is said to have presented, if Sri Lanka is to restore the lost faith in the health sector, the existence of the system of undefined or vaguely defined emergencies and non-time-bound emergencies that allow for such waivers of registration, should be revisited.
In addition, responsibility on the part of institutions such as the Health Ministry and the NMRA should receive more attention.While the fact that health authorities took immediate and necessary measures as soon as the aforesaid irregularity came to light is appreciable, the fact that it was allowed to happen in the first place is not a flaw that can be downplayed, or addressed through a mere ban on the distribution and/or use of the said medicine. Sri Lanka needs to take measures to avert economic crisis-related vulnerabilities from creating a breeding ground for irregularities.
The free healthcare service needs to be safe and reliable too, and that is not a negotiable standard, regardless of the circumstances.