Ncube Bakani Mark, Dube Admire, Ward Kim
School of Pharmacy, University of the Western Cape, Bellville, South Africa.
Front Med (Lausanne). 2023 Jan 30;10:1117439. doi: 10.3389/fmed.2023.1117439. eCollection 2023.
In 2016, the African Union (AU) Model Law on Medical Products Regulation was endorsed by AU Heads of State and Government. The aims of the legislation include harmonisation of regulatory systems, increasing collaboration across countries, and providing a conducive regulatory environment for medical product/health technology development and scale-up. A target was set to have at least 25 African countries domesticating the model law by 2020. However, this target has not yet been met. This research aimed to apply the Consolidated Framework for Implementation Research (CFIR) in analysing the rationale, perceived benefits, enabling factors, and challenges of AU Model Law domestication and implementation by AU Member States.
This study was a qualitative, cross-sectional, census survey of the national medicines regulatory authorities (NRAs) of Anglophone and Francophone AU Member States. The heads of NRAs and a senior competent person were contacted to complete self-administered questionnaires.
The perceived benefits of model law implementation include enabling the establishment of an NRA, improving NRA governance and decision-making autonomy, strengthening the institutional framework, having streamlined activities which attract support from donors, as well as enabling harmonisation, reliance, and mutual recognition mechanisms. The factors enabling domestication and implementation are the presence of political will, leadership, and advocates, facilitators, or champions for the cause. Additionally, participation in regulatory harmonisation initiatives and the desire to have legal provisions at the national level that allow for regional harmonisation and international collaboration are enabling factors. The challenges encountered in the process of domesticating and implementing the model law are the lack of human and financial resources, competing priorities at the national level, overlapping roles of government institutions, and the process of amending/repealing laws being slow and lengthy.
This study has enabled an improved understanding of the AU Model Law process, the perceived benefits of its domestication, and the enabling factors for its adoption from the perspective of African NRAs. NRAs have also highlighted the challenges encountered in the process. Addressing these challenges will result in a harmonised legal environment for medicines regulation in Africa and be an important enabler for the effective operation of the African Medicines Agency.
2016年，非洲联盟（非盟）《医疗产品监管示范法》获非盟国家元首和政府首脑批准。该立法的目标包括协调监管体系、加强各国间合作，以及为医疗产品/卫生技术的开发与推广提供有利的监管环境。设定的目标是到2020年至少有25个非洲国家将该示范法纳入国内法。然而，这一目标尚未实现。本研究旨在应用实施研究综合框架（CFIR）分析非盟成员国将非盟示范法纳入国内法并实施的理由、感知到的益处、促成因素和挑战。
本研究是对非洲英语和法语国家非盟成员国的国家药品监管机构（NRA）进行的定性、横断面普查。联系了NRA负责人和一名高级主管人员以完成自填式问卷。
实施示范法的感知益处包括能够设立NRA、改善NRA治理和决策自主权、加强机构框架、简化活动以吸引捐助方支持，以及实现协调、互信和相互认可机制。促成纳入国内法和实施的因素包括政治意愿、领导力以及该事业的倡导者、推动者或拥护者的存在。此外，参与监管协调倡议以及希望在国家层面制定允许区域协调和国际合作的法律条款也是促成因素。在将示范法纳入国内法并实施的过程中遇到的挑战包括缺乏人力和财政资源、国家层面相互竞争的优先事项、政府机构角色重叠，以及法律修订/废除过程缓慢且冗长。
本研究有助于从非洲NRA的角度更好地理解非盟示范法进程、其纳入国内法的感知益处以及采用该法的促成因素。NRA还强调了该过程中遇到的挑战。应对这些挑战将为非洲药品监管营造一个协调一致的法律环境，并成为非洲药品管理局有效运作的重要推动因素。
