9 March 2021 · Global Partnership for Zero Leprosy

GPZL Convenes Stakeholders to Address MDT Supply Chain Challenges

The Global Partnership for Zero Leprosy (GPZL) convened a group of leprosy stakeholders virtually on 25 February 2021 to discuss the multi-drug therapy (MDT) supply chain. Meeting attendees sought to better understand the intricacies of MDT supply and discuss solutions to past and ongoing challenges.
This meeting continued the work of the Leprosy Emergency Operations Committee (LEOC), which convened MDT stakeholders in 2020 at the onset of the COVID-19 pandemic, by bringing together a larger group. This meeting was a step in the continued effort to resolve ongoing MDT supply chain issues. Meeting attendees included representatives from the ILEP Panel of Women and Men Affected by Leprosy, Novartis, the World Health Organization (WHO), ILEP Technical Commission, National Leprosy Programme of Ghana, International Federation of Anti-Leprosy Associations (ILEP), and Sasakawa Health Foundation.

Representatives from Novartis Global Health and WHO Strategic Operations provided an overview of the history of MDT donation, the supply process, operational challenges, roles and responsibilities within the supply chain, and communication flow of MDT supply-related information.

The WHO Leprosy Donation Programme, a partnership between Novartis and WHO, has supplied free MDT to all leprosy patients around the world since 2000. The supply chain is a lengthy, continuous process for both the flow of medicine and information. A country prepares leprosy data and submits a request to WHO for drug supply. Sandoz India, a Novartis Company, supplies MDT orders and stock replenishment to WHO Regional Offices as well as WHO Headquarters in Geneva and WHO offices in Manila. It takes time to complete this process, with larger orders requiring 3 – 4 months. Importation processes within countries can also lengthen the time it takes to deliver the drug from the manufacturer to the people that need it. 

Since 2019, WHO has issued three letters warning of potential shortages of MDT supply. In December 2019, countries were notified of a dapsone shortage due to production issues. Because all countries are supplied with 6 – 8 months of buffer stock, WHO received no reports of stockouts due to dapsone shortage. New issues arose related to MDT production and shipment in early 2020 as a result of COVID-19 lockdowns. Following a short interruption, all manufacturing resumed. In late 2020, WHO issued a third letter about impurities in rifampicin. MDT was put on hold while a risk assessment was shared with WHO. New batches that met the FDA Guidance (dated 26 August 2020) were released, and previously released MDT were assessed for risk and determined safe. WHO currently prioritizes MDT shipments to countries that are nearing or experiencing stockouts.

Still, patients in some countries report that they cannot access MDT.  Meeting participants identified a need to improve communication at the local level, from country offices to local health clinics, to patients. GPZL is currently working with partners to identify potential avenues to ensure that persons affected by leprosy have better access to information about leprosy medication, not only MDT but also for reaction treatment and preventive chemotherapy. Following this meeting, GPZL will continue to convene partners to support the leprosy community in ensuring that leprosy medication and timely information reach every patient.