The use of medical products such as pharmaceuticals, biologicals including vaccines, blood products, and medical devices, including in vitro diagnostics, is essential in the healthcare provision system [1, 2]. Every country should ensure an adequate supply of safe, efficacious, good quality, and affordable medical products to promote public health [3].Effective regulatory systems ensure that the medical products meet the recommended standards to protect and promote public health [4, 5]. All countries globally are encouraged to have functional, effective, and efficient National Regulatory Authorities (NRAs) [6]. However, at least 30% of the existing NRAs have constrained capacity to perform core regulatory functions [7, 8].
Medical products are allowed for use after the respective NRAs approve them. The requirements to obtain such approval differ among NRAs based on their regulatory capacity [9, 10]. The regulatory review process requires a considerable amount of time and adequate skilled personnel, impacting the availability of registered medicines [9, 11].
According to World Health Organization (WHO), Africa has 54 NRAs with varying capacities, but most cannot perform the critical regulatory functions [12]. A WHO report estimates that only 30% of NRAs among its Member States can effectively and efficiently regulate medical products in their countries [12]. WHO and its Member States require that medical products be registered; this involves the regulatory review of the quality, safety and efficacy data, good manufacturing practice inspection and licensing of the concerned manufacturing site before approval for marketing [10, 11, 13]. Such medical products may or may not have obtained the relevant authorization from the NRA in the source market [14, 15]. The 2017 WHO definition of poor-quality medicines includes “Unregistered/unlicensed medical products that have not undergone evaluation and/or approval by the National or Regional Regulatory Authority for the market in which they are marketed/distributed or used, subject to permitted conditions under national or regional regulation and legislation”[16]. There is evidence to demonstrate that unregistered medicines are associated with an increased incidence of adverse drug reactions and that despite advances in medicine regulation and guidance from professional organizations, the use of unregistered medicines [17, 18] in at-risk populations has not reduced [19, 20]. Moreover, the prevalence and impact of unregistered medicines is greater in low and middle-income countries due to the less mature regulatory systems as well as financial and human capacity constraints [21].
Ineffective delivery of quality healthcare services has led to shortages of medicines worldwide, including the Southern African Development Community (SADC) region [22,23,24,25]. Medicines shortages can be worsened in the absence of functional NRAs, exposing the public to potentially unsafe and spurious medical products. Medicines shortages can also be caused by changes in pharmaceutical manufacturers' marketing strategy, supply chain challenges, unexpected surges in demand, production-related issues, global pandemics such as Ebola and Covid-19, and natural disasters such as cyclones, among others [22, 23, 26].These factors create a vacuum for the availability of the medicines approved by the NRAs, leading to the demand and the use of medicines that have not undergone regulatory review approval process. Therefore, the importation and distribution of unregistered medicines is a global phenomenon that is often necessary to bridge the supply chain gaps, and this is expected to continue into the foreseeable future.
To objectively assess each NRA and create an opportunity for strengthening regulatory systems, WHO developed a Global Benchmarking Tool (GBT) [9]. The GBT assesses the strengths and weaknesses in the various regulatory functions and scores the system in terms of maturity levels (ML), ranging from 1 to 4 [2, 17]. In addition, the GBT assesses the availability of legal provisions, policies, manuals, guidelines, Standard Operating Procedures (SOPs), infrastructure, and availability of adequate and skilled personnel, which are all critical factors for effective regulation of medicines[2, 13, 17]. The use of unregistered medicines is expected to continue for the foreseeable future, raising concern globally, as documented in previous studies [27]. Of concern is that unregistered medicines' quality, efficacy, and safety remains unknown to the importing countries [28]. Therefore, to safeguard public health, the approval processes for importing and distributing unregistered medicines should be robust to mitigate the potential risk posed by such exemptions from the normal registration processes required to protect public health. The potential increase in the risk of adverse medical events or lack of therapeutic effect is also a cause for concern emanating from the importation of unregistered medicines [16, 27].
To our knowledge, the legal provisions and requirements set by each NRAs in the SADC region when approving the importation and distribution of unregistered medicines, similarities, differences, robustness, and challenges remain unknown as the processes are not usually published; hence no opportunity for knowledge sharing and or transfer. The objectives of this study were to review and determine the level of implementing the legal provisions and requirements for the importation of medicines across the SADC NRAs. The study provides baseline data for creating a regional guideline for good practices when importing unregistered medicines to protect public health. The identified gaps can be included in the institutional development plans for each NRA to enhance the regulatory systems strengthening within the region.