National medicines regulatory authorities financial sustainability in the East African Community

Abstract

Introduction Adequate and sustainable funding of national medicine regulatory agencies (NMRAs) is key for assurance of quality, safety and efficacy of medical products circulating in a market. The study aimed to determine factors affecting NMRAs funding in five East African Community (EAC) countries namely: Burundi, Kenya, Rwanda, Tanzania (Mainland and Zanzibar) and Uganda. Methodology An exploratory, mixed method design using both qualitative and quantitative data, was employed. Data from six NMRAs was collected through a combination of semi-structured interviews, questionnaires, and checklists for the period 2011/12-2014/15 while 2010/11 data served as baseline. Interviews were conducted with heads of NMRAs and monitoring and evaluation experts of the respective agencies. NMRA's financing was assessed using six indicators namely, funding policy, financial autonomy, the total annual budget, actual funding per annum, funds received from various sources, and the NMRA expenditure. Results The average total annual budget for all the EAC countries during the study period 2011-2015 ranged from USD 824,328.67 to USD 10,724,536.50. The low budget in Zanzibar may be attributed to population and pharmaceutical market size. Uganda's attainment of 98.75% (USD 10,656,704) revenue from industry fees is a result of deliberate government policy change from 100% reliance on donor funding over a period of 10 years (1995-2015). On average, the proportion of revenue against budget per annum is 54.8% (USD 458,970.11),

Harmonization of medical products regulation: A key factor for improving regulatory capacity in the East African Community

“…This publication is a continuation from a previous paper which looked at factors affecting nancial sustainability of NMRAs in the EAC region [42]. For the purpose of this paper, ndings are categorised into ve main categories namely policy and legal framework, NMRA governance, medicines registration and good manufacturing practice (GMP) systems, quality management systems and information management systems..…”

Harmonization of medical products regulation: a key factor for improving regulatory capacity in the East African Community

“…During this period, both annual and three yearly data were gathered. A pilot situational analysis study informed the designing of the data collection tools [ 24 , 26 , 27 ]. In addition, we adopted other questions from the WHO Global Benchmarking Tool (WHO-GBT) for the Assessment of National Regulatory Frameworks [ 28 ].…”

“…The second round involved the conduction of semi-structured face-to-face interviews to one staff from medicines registration, GMP inspections, legal affairs, human resource and finance departments in addition to the previous set of respondents. One to two respondents were involved in each 1 to 2 h long interview session [ 24 ].…”

“…Follow-up visits were carried out to capture the incomplete data and verify the previously obtained data. Confidentiality of all respondents was highly observed thought the study [ 24 ].…”

Harmonization of medical products regulation: A key factor for improving regulatory capacity in the East African Community

“…The second round involved the conduction of semi-structured face-to-face interviews to one staff from medicines registration, GMP inspections, legal affairs, human resource and nance departments in addition to the previous set of respondents. One to two respondents were involved in each 1 to 2 hours long interview session [24] An acceptance letter and an interview subject guide were sent to the interviewees in advance. Moreover, we obtained a permission to record the responses in form of selected written notes from each respondent.…”