Registration and local production of essential medicines in Uganda

Abstract

Background: Universal access to high quality essential medicines is critical to sustainable development (SDG 3.8). However low-and middle-income countries struggle to ensure access to all medicines on their national essential medicines lists (EML). Market registration is the first step in determining both access and availability yet the extent to which essential medicines are registered for use at country level is not known. Companies apply for a marketing authorisation, however low price or lack of a market is a disincentive. Local production has been promoted to ensure availability of essential medicines but research in this area is also limited. Methods: The study took place between 2011 and 2015. We systematically examined the registration status of medicines and vaccines listed in the Ugandan 2012 EML and conducted 20 interviews with regulators, ministry of health representatives, donors, and pharmaceutical producers and analysed quality assurance issues affecting registration, procurement, and local production of medicines in Uganda. In 2017 we conducted a further three interviews to clarify issues around non-registration of essential medicines highlighted by our analysis. Results: Of the 566 essential medicines and vaccines nearly half (49%; 275/566) had no registered product in 2012. Of the 3130 registered products, just over a quarter (28%; 880/3130) were listed on the EML. Six local producers had registered 138 products of which 40 corresponded to 32 unique essential medicines. Interviews highlighted alternative routes to availability other than registration. Local producers faced considerable barriers to achieving international quality standards required for international procurement of medicines for the domestic market. Conclusions: Monitoring and audit of the registration of essential and non-essential medicines should be a priority nationally and, regionally through harmonisation of registration requirements in the East African Community. National and regional manufacturing plans should consider local production of unregistered essential medicines.

Evaluation of Drug Trials in High-, Middle-, and Low-Income Countries and Local Commercial Availability of Newly Approved Drugs

“…Finally, regular and transparent tracking, auditing, and reporting on product registrations in countries hosting trials could better help advance access to medicines and vaccines globally. 42 To aid in this process, it would be helpful to increase transparency around trial site locations.…”

National adaptation and implementation of WHO Model List of Essential Medicines: A qualitative evidence synthesis

“…However, reimbursement processes are increasingly critical in LMICs with respect to achieving UHC, which means financial risk protections and prevent the patient from incurring high out-of-pocket expenses for essential medicines. Several papers in our review described the high out-of-pocket costs for patients, regardless of whether medicines are listed on NMLs [ 20 , 22 , 39 , 45 , 47 ].…”

“…Brhlikova and colleagues found that in Uganda, following increases to government funding for essential medicines, demand for locally produced medicines also increased [ 47 ]. While adding drugs to a NML is a sign of increased priority by the government, pharmaceutical manufacturers may not necessarily respond unless other factors, such as the potential for profits, are addressed.…”

“…Moreover, donors in Uganda were operating outside of the national policy environment and distributing medicines at the community level through vertical health programs [ 39 ]. In their study from Uganda, Brhlikova and colleagues reported that donor procurement policies were hindering local production of medicines [ 47 ].…”

Implementing essential diagnostics-learning from essential medicines: A scoping review

“…This was related to high workload, poor remuneration, and non-payment of stipends 36, 41, 75, 158 . Other barriers reported include non-payment of suppliers 70 and low tax incentives and subsidies to pharmaceutical companies 170 to support EML implementation.…”