•Save us from imminent life-long paralysis
•How bureaucratic bottlenecks worsen cases
From Fred Ezeh, Abuja
Thousands of leprosy patients in Nigeria are faced with serious existential threat because of the prolonged absence of Multi-Drug Therapy (MDT), a critical drug for the treatment for leprosy.
The last batch of MDT was delivered to the lepers’ community in the first quarter of 2024. Since then, efforts made for the procurement and arrival of another batch of consignment has not yielded fruits.
Investigations revealed that Coordinating Minister of Health and Social Welfare, Prof. Muhammad Ali Pate, as well as officials of the ministry particularly the National Tuberculosis, Leprosy and Buruli Ulcer Programme, are aware of the challenges. While some fingers at the ministry pointed at the country office of World Health Organisation (WHO), others pushed the blame to the National Agency for Food and Drug Administration and Control (NAFDAC), for their poor interest in the procurement and distribution of MDT.
Lepers insisted that the development has heightened the risk of over 3000 persons (new cases found) including 800 children (five to 15 years) and thousands of other existing cases coming down with lifelong disabilities, even when there are reports of large number of yet-to-be found cases, particularly among children across several states.
Information at the ministry indicated that the development was not deliberate, but due to prolonged disagreements between NAFDAC, WHO and the Indian company manufacturing the drugs responsible for the prolonged delay.
Unfortunately, the situation seems to be getting worst because of the fact that the window provided by NAFDAC for the necessary documentation and clearance for the drugs has expired, thus resulting in fresh application process for the drugs, which might take time.
How it started
Few weeks ago, the leper community raised the alarm that the delay in supply and distribution of the MDT drugs was taking longer than necessary. It confirmed that the last supply was in first quarter of 2024, and the prolonged delay in procurement and distribution had triggered increased anxiety and concern levels of the patients.
One of the patients and key member of the leper community in Abuja who pleaded anonymity told Daily Sun that for 12 months, the supply of MDT has not been forthcoming. That left over 3,000 individuals recently diagnosed of the disease without medication they urgently need to survive, remain relevant in the society, and contribute to the socio-economic growth of Nigeria.
He attributed the delay to some bureaucratic bottlenecks and regulatory requirements poses dire consequences for those of them living with leprosy, and for public health in Nigeria.
He stated that the supply process for MDT under WHO Purchase Order Number: 203416835, has been obstructed due to additional requirements from NAFDAC, particularly the request for Certificate of Pharmaceutical Product (CoPP) for Rifampicin, despite its global acceptance as a donated drug.
“A critical NAFDAC permit expired on December 31, 2024, and the Clean Report of Inspection and Analysis (CRIA) results will also elapse by February 2025, potentially resulting in starting the lengthy supply process afresh.
“But without immediate intervention, procuring the MDT solution might extend till late 2025, thus leaving patients untreated for long, thus increasing the risk of life-long disabilities, and reversing progress in leprosy elimination goal set for 2030. These are our major concerns.”
Investigations revealed that the request for the procurement of the MDT was submitted to the Indian company for the drugs, perhaps, through the WHO.
MDT is a blister that contains three tablets, and based on international standards and procedures, the pharmaceutical company that manufacture the drug must provide a Certificate of Pharmaceutical Product (CoPP) that attests to the fact that the drugs are good and safe for human consumption. That has not been done.
However, CoPP has been received for two tablets in the MDT blister. Unfortunately, the remaining one tablet that has not been certified has the major pharmaceutical component for the leprosy treatment.
An official of the ministry confirmed that the Indian company has been frustrating the efforts to procure the drugs. “They have been foot-dragging in providing the CoPP that’s required for the completion of procurement and distribution processes. That’s the standard procedure and requirements, and they are fully aware of it.
“It may be that they don’t trust the pharmaceutical content of the drugs, hence they don’t want to provide the Certificate of Pharmaceutical Product (CoPP) to certify the drugs. And on our side, we won’t, for any reason, procure and distribute drugs to Nigerians without CoPP. That could be dangerous to the health of Nigerians because no one would be held responsible for any negative results.”
Leprosy, NTDs, 2030 target
Leprosy is one of the about 20 Neglected Tropical Diseases (NTDs) yet to be eliminated in Nigeria, even though 2030 has been set as the global target for the eradication of the diseases.
But stakeholders involved in the fight against NTDs, particularly leprosy are concerned that the development in Nigeria as regards the unavailability of MDT drug might affect the chances of Nigeria eliminating the disease and other NTDs in 2030.
Isiaka Yushu’a, a member of the leper community in Abuja, suggested a serious effort and commitment to the fight against leprosy, and other NTDs.
He suggested a national commitment from government at all levels that will lead to nationwide testing, case finding, contact tracing, and treatment. “This will help disrupt the transmission of the diseases. Remember that leprosy is a communicable disease, hence anyone can contract it.
“Many states in Nigeria claimed they had no case of leprosy, but that is because there’s no case finding nor contact tracing efforts going there. If such nationwide projects should be conducted, you will be amazed on what would be found.”
Lepers’ frustration
Mr. Peter Iorkighir Terver, President of Integration Dignity and Economic Advancement (IDEA-Nigeria), an umbrella body of leprosy patients in Nigeria, told Daily Sun that Nigeria won’t meet the 2030 target as regards the elimination of leprosy and other NTDs.
He said: “The signs are there for all to see. Our case finding system is very deficient. This 3000 figure being used was from just four states where not thorough case finding was done. Imagine if diligent and proper case finding is done across the country, the result will be massive. Sadly, the already found cases are not on drugs.
“Nigeria is fighting for the elimination of leprosy and other NTDs in 2030, but there’s no budget to achieve that. For you to achieve such a goal, you must start with contact tracing, find the cases, treat them, to ensure that the transmission is not there again.
“We are having new patients that practically rely on other sources for help, and those sources have even stopped offering the helps because they could no longer afford it. Remember that the figure mentioned earlier are some of the new cases that are not on drugs.
“Currently, the diagnosis has been suspended, and that was because there’s no drug to attend to the new cases. Diagnosis might resume when drugs arrives. Early access to the drugs is critical in the fight against the disease because it protects and prevents the new cases from degenerating into lifelong disabilities. I was lucky to have taken my own drugs early, and that was the reason my case was under control.”
He said the plight of leprosy patients can not be ignored, stressing that the delays in MDT procurement and distribution is avoidable, and their consequences are preventable, and urged all stakeholders, notably, government officials, regulatory agencies, and the international community, to act swiftly and decisively.”
He promised that IDEA-Nigeria, on behalf of persons affected by leprosy, is ready to work collaboratively with all concerned parties to ensure the crisis is resolved. “We owe it to the marginalized among us to uphold their dignity, health, and humanity.”
WHO response
MDT, a combination of three medicines (dapsone, clofazimine, and rifampicin), has been the cornerstone of leprosy treatment since the 1980s. The World Health Organization has facilitated the provision of MDT medicines worldwide, free of charge, through generous donations initially financed by The Nippon Foundation (1995–1999) and subsequently by Novartis since 2000. To date, more than 16 million leprosy patients have been successfully treated with MDT.
In Nigeria, WHO is actively working with the government to ensure the timely shipment and distribution of MDT. WHO facilitated the shipment of the donated leprosy medicines over three decades which were produced from the same manufacturer. However, a new regulation introduced in Nigeria in 2021 requires additional steps in the administrative process.
WHO is currently working closely with NAFDAC to ensure compliance with the regulations while maintaining the quality and safety of the medicines. The shipment of MDT medicines is ready to go, and WHO remains committed to supporting the government in ensuring the uninterrupted availability of these essential drugs.