News
Govt.-to-Govt. medicine purchases planned; pharma industry protests
View(s):By Namini Wijedasa
The Health Ministry will appoint a committee to facilitate direct procurement of medicines from foreign governments.
The move, which is opposed by the pharmaceutical industry, was approved by the Cabinet. The ministry plans to obtain direct assistance from such governments “until present issues within the medicine supply chain are resolved and disruptions are minimised,” a Health Ministry statement said on Friday.
The Cabinet has approved the setting up of a committee “to oversee and implement future steps under this mechanism”. Thereafter, the ministry will—with the agreement of the National Procurement Commission—submit a fresh proposal to the Cabinet for “necessary final approvals”.
Letters were recently sent to foreign governments through Sri Lanka’s missions abroad to explore the possibility of buying medicines on a government-to-government (G2G) basis, the Sunday Times learns. They are India, Pakistan, China, Indonesia, Turkey and Bangladesh. A list of 111 drugs is attached to the note verbales.
This newspaper saw a copy of the communication sent to the Bangladesh Foreign Ministry, expressing the Sri Lankan government’s intention to purchase the medicines urgently. It has requested Bangladesh to provide a list of documents which are considered mandatory to proceed, including certificates of analysis for the products and GMP (Good Manufacturing Practice) certificates.
Health Ministry Secretary Anil Jasinghe said in the case of drugs so procured that do not have prior registration from the National Medicines Regulatory Authority (NMRA), waivers of registration (WoRs) will be issued. He also said G2G will not be a “routine” method of sourcing medicines but that “we have to have that option”.
All major pharmaceutical unions have opposed the move. In a letter to the Health Minister sent earlier in May, the Sri Lanka Chamber of Pharmaceutical Industry (SLCPI), the National Chamber of Pharmaceutical Manufacturers of Sri Lanka and the Sri Lanka Pharmaceutical Manufacturers’ Association warned that it could have “serious and far-reaching consequences, including risks to patient safety due to the influx of substandard or unregulated medicines”.
Other concerns flagged was the risk of the decades-old local pharmaceutical manufacturing industry collapsing; loss of livelihoods with thousands of jobs at risk; and a negative impact on the local economy, including increased dependence on imports and foreign exchange outflows.
The unions also alleged there was a “false premise” of a widespread drugs shortage “potentially driven by misinformation provided by officials with vested interests”. They claimed the prevailing medicines shortages had been artificially created “by deliberately delaying product procurement processes, delayed registrations of existing importers and local manufacturers, ignored [sic] available stocks of existing importers and local manufacturers and “manipulated procurement processes to justify this opaque G2G mechanism.”
Government officials counter, however, that the pharma industry has formed cartels that rig prices and also manipulate the tender process. This has led to the creation of monopolies and oligopolies in the supply of certain medicines. “The end result is the shortage of drugs,” one senior Health Ministry administrator said.
The Sunday Times obtained the official table of 111 drugs listed for import through the G2G route. An analysis of the “pending order status” column showed that administrative and procedural delays were the leading reasons for delay in securing the medicines.
For instance, there were six instances of files stuck at the procurement unit, three instances of files held at the procurement committee, three other instances of files being at the ministry procurement committee, two instances of the files being at the technical evaluation committee, and four instances of “file at evaluation”.
Additionally, “indent to be issued” appears five times; “PO [purchase order] to be issued” appears four times; and “awaiting WoR” appears five times. There are 15 examples of supplier availability and responsiveness issues. “No solution for the next 03 months” is listed seven times; “no registered supplier/sources” appears twice; “non-responsive supplier/bidders” appears thrice; and “re-tender”, twice.
Financial and pricing challenges account for 20 instances. “LC [letters of credit] to be established” is listed at least 10 times, indicating that tenders are finalised but blocked at this stage. This is one of the most frequent delays identified.
“Under evaluation” is blamed eight times, while “MRP [maximum retail price] exceeded” appears twice.
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