Evaluation of the implementation and the associated operating costs of a medicine regulatory harmonisation model in Africa: the case of ZaZiBoNa, a SADC work-sharing initiative.

Abstract

Background: To improve the access to and affordability of medicines, countries in the Southern African Development Community (SADC) established ZaZiBoNa, a medicine regulatory harmonisation initiative. Studies have evaluated the initiative's technical and operational efficiencies and effectiveness. This study evaluated ZaZiBoNa from project implementation and cost perspectives, at the 5-year mark, to establish a business case for further investment.

Methods: A quantitative and desk review were undertaken. Two surveys, one with 7 National Regulatory Authorities (NRAs) that participated in the initiative in the initial 5 years were conducted and the other with 40 pharmaceutical companies who submitted applications in the same period were recruited to share their perceived experiences and expectations with the collaborative initiative.

Results: All 7 NRAs agreed the initiative had generally achieved its objectives and participation was beneficiary. As of June 2022, the 7 NRAs had registered 152 of the 235 (64.7%) products assessed during the study period, with a median time from joint assessment recommendations to registration of 7 months, against a target of 3 months (range: 4 to 14 months). Of the industry respondents (n = 13), 61.5% indicated the initiative had had a positive impact on their business, though expectations were only met to some degree (31%-46%). Failure to create a less expensive process and to facilitate simultaneous multiple market access (31% and 23% respectively) were the most common unmet expectations. Nonetheless, 62% of the industry respondents expressed willingness to continue utilising the collaborative process. The cost per joint assessment recommendation during the study period was USD 2,768.

Conclusion: The study also highlighted that implementation of initiatives could take time and that some goals can only be achieved in the medium to long term. This is a lesson for other collaboration initiatives in Africa, such as the African Medicines Agency.