• Time sought to implement report’s complex recommendations
• SLACPT flags lack of transparency, absence of efficient software system
• Lack of coordination amongst stakeholders blamed
• Registration of essential medicines not prioritised

A report prepared by the Sri Lanka Association of Clinical Pharmacology and Therapeutics (SLACPT) on request by the Ministry of Health (MOH) on ‘Challenges and barriers for effective supply of medicines to the State sector’ has laid bare the stark realities and causes behind the enduring pharmaceutical shortage that the public health system has been facing over the last year.

The report, which The Sunday Morning has seen, was prepared last month and has been submitted to the Ministry of Health. 

Implementation of the recommendations are expected to take time given the complexity of the matter, Minister of Health Keheliya Rambukwella said, responding to a question. 

The Health Minister, who has been the target of many allegations and is set to face an Opposition-driven no-confidence motion, would not comment further on the report or its recommendations, but said that the Government was moving quickly to increase the number of registered suppliers in order to grow competitiveness and secure better bids for tenders.

The 75-page report by the SLACPT identifies 22 challenges and barriers for effective supply of medicines to the State sector and makes 30 recommendations. 

The report also acknowledges five observations made by the Treasury and 14 challenges identified by the Auditor General and cites non-implementation of recommendations given in the Auditor General’s recent reports towards improvement in the processes, especially those covering monetary aspects, as a key contributor.

According to the executive summary of the report, the absence of an efficient software system to obtain updated information in a transparent manner on medicines ordered, tenders awarded, medicines registered, those pending registration, those granted Waivers of Registration (WORs), quality failures, stocks available, dates of the expected consignments, and purchasing costs by all stakeholders, is a core issue.

Lack of transparency in the registration and procurement processes, lack of coordination amongst stakeholder groups during the estimation and current procurement process, and delays in Technical Evaluation Committee (TEC) and tender committees have also been flagged.

The report also identifies delays in the steps in the supply chain at all levels, especially by the NMRA, MSD, and the SPC contributing to the shortages of medicines and other medical supplies. Inadequate staff and expertise at the NMRA, MSD, NMQAL, and SPC and the sudden removal of staff have also been identified.

Another key issue flagged is the lack of an efficient system for forecasting of the annual requirements by the pharmacists at the MSD. Non-prioritisation and not allocating a minimum of 70% of the available funds to purchase the essential medicines have also been cited.

The absence of a regularly-updated database of registered medicines with the Maximum Retail Price (MRP) at the NMRA has been reported as a concern.  

The report also cites non-adherence to recommended procedures and guidelines during the procurement process by the SPC as a concern, while highlighting that political and other interferences to the existing systems cause serious implications for the supply system.

The lack of expertise and shortage of staff and accredited testing facilities for the NMRA and the National Medicines Quality Assurance Laboratory (NMQAL) have been listed as a major challenge for effective supply.

The report recommends the formulation a new unit under the MOH with a Technical Advisory Committee, with representation from colleges to review on a regular basis the shortages, analysis of annual pharmaceutical supplies, rational usage, annual budgetary allocation, purchases, and cost analysis of supplies in order to make recommendations on rational spending on pharmaceuticals, advice on decisions required during the processing of tenders, and the procurement process to prevent shortages and problems in supply.

It also recommends establishing an electronic system where all stakeholders (MSD, SPC, NMRA, colleges, and end users in hospitals) will be able to obtain relevant data such as medicines requested, medicines registered, those pending registration, those granted WOR, quality failures, orders, stocks available, dates of the expected consignments, prices, purchasing costs, etc.

The restart of electronic submissions in the Electronic Common Technical Document (eCTD) format as soon as possible to make the process transparent and enable traceability and monitoring is also among the recommendations.

The report also recommends avoiding interference to the proper functioning of organisations, such as the recent transfer of several experienced staff at NMRA, and to take steps to increase the staff at NMRA and NMQAL urgently if necessary, by obtaining special permission for recruitment.

The SLACPT also recommends increasing the quality testing capacity of NMQAL by increasing the analytical staff and other resources required and obtaining testing from other independent laboratories such as universities or private laboratories capable of performing quality testing in the interim.