7 September 2023 12:00 am Views - 378
The Committee of Experts of the Ministry of Health to “Examine the identification of impediments in the procurement of quality drugs and equipment at competitive prices: Adoption of Simple and Transparent Procurement Methodologies: and Restructuring of the National Medicine Regulatory Authority [NMRA]” by the Cabinet, has called for written submissions before September 13.
Restructuring of NMRA?
However, the perplexing aspect is the Terms of Reference, which include the Restructuring of NMRA, with a significant focus on the procurement of medicines. This is puzzling because NMRA’s primary responsibility is related to the registration of medicines, not the procurement or purchasing of them. There appears to be a lack of awareness about this within the Ministry.
Appointing Commissions and Committees for various issues, along with these committees seeking public participation through written and oral submissions, is a familiar approach by politicians. These methods are often viewed as tactical manoeuvres to navigate challenging situations or as temporary appeasements in response to public discontent. Unfortunately, once the initial public outcry subsides, the reports, recommendations, and public input often seem to be shelved and forgotten while the politician’s agenda at the expense of the taxpayers resumes as usual.
Before we discuss the Committee, it is important to discuss the main issue - “Regulation of Medicines”. Where the public has good product knowledge e.g., food, clothes, and household items, minimal regulation suffices. However, when buyers do not have the necessary product knowledge [medicines is a classic example], robust government regulation becomes vital to protect the public. In addition, for medicines safety, quality, and efficacy are paramount. Therefore almost all nations regulate medicines while cooperating internationally. Government regulation of medicines, like defence, and police is a part of the duty of the state. In medicine, public well-being is prioritized over trade interests. Health first, trade follows. Our primary objective is to educate the public and make them a part of the movement that will result in better medicine regulation.
The Drug Evaluation Sub Committee (DESC) of the Ministry of Health was key in the medicines that were allowed into the country from the 1980s till the NMRA was established in 2015. Being a small (but technically expert) committee, it took notice of the decisions of the well-resourced authorities in the US, UK, Australia etc. The DESC was also careful with medicines from neighbouring countries such as India, Pakistan and Bangladesh, allowing only manufacturers that had assured quality and supplying internationally to supply to Sri Lanka. Nevertheless, there were some quality failures that potentially made the drug ineffective BUT did not pose a danger to the patient. Thus, there were no verified deaths due to toxic and unsuitable medicines in Sri Lanka.
In addition, when the DESC judged some medicines that were approved by other authorities but not suitable for Sri Lanka, the application was kept aside. In some medicines (nimesulide, mibefradil) this caution was justified as the medicines were later withdrawn due to serious side effects.
The NMRA functioned from 2015 and there were “teething” problems; however it showed good potential and the World Health Organisation, Geneva had several workshops to improve its standards and to make the NMRA an example to the other Medicines Regulators in the region. A highly efficient authority was desirable but the NMRA was able to ensure a steady supply of safe, effective, medicines of assured quality. Importantly, there was no interference from the Minister or the officials in the Ministry of Health.
However, in recent times there has been severe interference in the NMRA by the Minister and Ministry officials which has damaged the NMRA and resulted in serious problems including deaths of patients.
One specific example cited is the tender for insulin by the Ministry, which was framed as an emergency procurement at an exorbitant cost but was for maintaining buffer stocks and, therefore a routine procurement. The NMRA was requested to allow this import without a full evaluation through a Waiver of Registration. This tender raises questions about irregular financial activities, the improper use of emergency procurement, and the safety and quality of insulin for diabetics in Sri Lanka. There was no transparency, accountability, and adherence to proper procedures in government procurement and regulatory processes.
Terms of Reference are confusing
The other issues are the Terms of Reference for the Committee are very confusing. The first sentence appears to mention two functions: “Adoption of Simple and Transparent Procurement Methodologies” and second, “Restructuring of the National Medicine Regulatory Authority.” These are two distinct activities, one focusing on improving procurement processes and the other on restructuring the regulatory authority itself.
The NMRA is similar to the Registrar of Motor Vehicles [RMV]. The NMRA primarily regulates and permits the import and distribution of medicines, ensuring their safety, affordability and quality. The function of procurement is typically handled by separate institutions. The Medical Supplies Division, State Pharmaceuticals Corporation and Private Sector are responsible for sourcing and importing/purchasing medicines. Therefore, it’s important to differentiate between the regulatory role of the NMRA and the procurement functions of other institutions, as they serve distinct purposes within the healthcare system.
The WHO has emphasized in its official publications that there should be a clear separation between the processes of registration and procurement to avoid conflicts of interest. It appears there may be a lack of understanding of fundamental regulatory principles among health bureaucrats. Additionally, there are other issues within the potential work of the Committee that could undermine; the meticulous efforts of esteemed Pharmacology Professors like Bibile, Lionel, and Kottegoda. The good system that existed from the 1970s ensured safe, effective, and quality medicines were procured. The present incompetent actions could potentially lead to the destruction of the work built over generations by these dedicated professionals. Indeed, these concerns underscore the critical importance of thorough deliberation and inclusive consultation processes to ensure that regulatory decisions are in line with best practices and maintain the integrity of healthcare systems.
Finally, to give an example known by all. There is no Polio in Sri Lanka – the high-quality vaccines from UNICEF registered by DESC and NMRA has meant no Polio from the 1990s. The DESC, in operation since 1980 until the NMRA, used a technical, scientific approach for reliable Polio vaccines.
Trained pharmacists and pharmacologists, possessing the necessary knowledge, are the sole decision-makers in the registration of medicines, with no involvement from administrators or politicians. The current managers responsible for medicines registration, however, are only medical administrators. The registration process involved careful evaluation, often waiting for new medicines to be used and tested elsewhere before considering their registration in Sri Lanka. This approach ensured that only proven and established medicines were introduced, avoiding potential risks associated with unproven or experimental medications.
However, there has been a recent shift where politicians and administrators are involved in technical decisions, potentially blurring the lines of expertise. Interference by administrators and politicians lacking technical competence in the registration process has resulted in waivers being granted without proper evaluation. This has allowed low-quality medicines to enter the market, leading to severe consequences, including patient deaths. Such individual decisions are susceptible to corruption. Furthermore, the lack of proper quality checks for waivers has compounded these problems. Tragically, it is the public who ultimately suffer, enduring avoidable suffering, disability and loss of life as a result.
When those responsible for safeguarding the public have abrogated their responsibilities, it is the public who must stand up to safeguard themselves.
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