Transparency in medicines registration decision making: A closer look at National Medicines Regulatory Authorities (NMRAs) within the Southern African Development Community (SADC) region.

Abstract

Medicines registration decision-making and regulatory best practice involve transparent and consistent rule making and processes with publicly available published assessment decisions and reports (Kaine, 2020). Publication of information relating to evaluation of medicines in the form of Public Assessment Reports (PARs) is one way of ensuring transparency in medicines registration decision making. It is however not clear whether National Medicines Regulatory Authorities (NMRAs) in the Southern African Development Community (SADC) region are in a position to generate or even publish such PARs / summary basis for registration of medicines. Objectives: The study investigated transparency in medicines registration decision-making processes for NMRAs within the SADC region. Specifically, the availability or non-availability of PARs / Summary basis for registration of medicinal products. To establish if all SADC NMRAs have legislative frameworks for regulating medicines and to investigate the sources of funding for SADC NMRAs. Methods: A cross-sectional exploratory descriptive study design with qualitative techniques by questionnaire as a data collection tool was used. Questionnaires were sent via email to senior members / key informants of 11 regulatory authorities belonging to SADC. Trend analysis was conducted based on the emerging themes from questionnaire response. Results The study revealed that currently five (5) NMRAs are operating as semi-autonomous agencies namely: BOMRA, MCAZ, PMRA, SAHPRA and TMDA .While NMRC, DNME of Angola, ACOREP of DRC and DNF of Mozambique are functioning within their respective Ministries of Health Departments. Furthermore, all NMRAs have a legislation framework governing the regulation of medicines in their respective jurisdictions. However, DNME of Angola’s legal framework is not yet officially formalised and as such, they follow a Presidential decree enacted in 2010. Four (4) of nine (9) NMRAs (44 %) reported to have more than 20 internal assessors / evaluators. This indicates a significant milestone for SADC NMRAs in terms of capacity building within the region. The study findings indicated that the SADC NMRAs are receiving funding from multiple sources ranging from a minimum of one to maximum of four funding sources. There were only two NMRAs, MCAZ and PMRA, that were not receiving funding from their governments. The study results further indicates that only TMDA is able to generate and publish PARs amongst SADC NMRAs. Conclusions: The findings in this study suggest that the majority of NMRAs within SADC are not yet matured as compared to countries in the developed world such as the US, Europe, Canada and Australia. It can also be concluded that for SADC NMRAs to be efficient and responsive, they will require massive financial resources. For example, the budget for a matured NMRA such as the US Food and Drug Administration (US FDA) for the 2019 financial year was estimated at US$ 5.7 billion. Literature further indicates that publication of the summary basis of approval or PARs is a norm for mature NMRAs and acts as a tool for regulatory authorities to build and establish confidence in their review processes and provides assurance regarding safety of medicines. The study results indicate that TMDA is publishing PARs or summary of grounds on which approvals are granted. This demonstrates a significant level of transparency in the TMDA medicines registration processes and therefore other SADC NMRAs can benchmark with TMDA to implement this key parameter.