The availability of medicines at facility level is the result of a structured process that spans multiple stages, from regulatory approval through to final dispensing. Each step in this pathway is governed by defined systems and responsibilities, and the interaction between these stages determines how efficiently medicines reach patients.
The journey begins with regulatory approval. In South Africa, all medicines must be evaluated and authorised by the South African Health Products Regulatory Authority (SAHPRA) before they can be marketed. This process involves the assessment of quality, safety, and efficacy data submitted by the manufacturer. For generic medicines, bioequivalence studies are required to demonstrate therapeutic equivalence to the originator product. For more complex products, including biologics, additional comparative data is reviewed [1]. Once approved, a medicine is registered and becomes eligible for inclusion in procurement processes.
Following registration, medicines intended for public sector use must be incorporated into national treatment guidelines and procurement frameworks. The National Department of Health (NDoH) plays a central role in this process, aligning medicine selection with the Essential Medicines List (EML) and Standard Treatment Guidelines (STGs). These tools guide clinical use and inform which medicines are prioritised for procurement at a national level [2].
Procurement in the public sector is primarily conducted through centralised tender processes. These tenders are typically awarded on a multi-year basis and define which suppliers will provide specific medicines, at what price, and in what volumes. This approach is designed to ensure price consistency and supply stability. However, the timing of tender awards and the transition between contracts can influence how smoothly supply is maintained. Delays in award finalisation or supplier onboarding may affect initial supply timelines if not aligned with manufacturing and distribution planning.
Once contracts are in place, suppliers begin the process of manufacturing and delivering medicines into the supply chain. This stage includes sourcing of raw materials, production, quality testing, and packaging. Many medicines rely on imported active pharmaceutical ingredients (APIs), which introduces dependencies on global supply chains. Lead times for production and delivery can vary depending on the product type and sourcing arrangements.
Medicines are then distributed to central and provincial depots, where they are stored before being allocated to healthcare facilities. Depot-level inventory management systems, such as RxSolution, are used to manage stock levels, track batch information, and process orders from facilities. Efficient depot operations are essential for ensuring that medicines move through the system without unnecessary delay.
From depots, medicines are distributed to clinics, hospitals, and pharmacies based on demand. Facility-level ordering is informed by consumption patterns, which are captured through reporting systems. The Stock Visibility System (SVS), for example, provides near real-time data on stock levels at facility level, allowing for improved monitoring and redistribution where needed [3].
The final stage in the journey is dispensing to the patient. At this point, healthcare professionals, including doctors, nurses, and pharmacists, play a critical role in ensuring that the correct medicine is provided, along with appropriate instructions for use. Patient understanding and adherence are important factors in determining treatment outcomes, but they are dependent on consistent availability of medicines at this stage.
Across this pathway, several points can influence efficiency. At the regulatory level, review timelines and dossier quality can affect how quickly medicines enter the market. At the procurement stage, forecasting accuracy and tender alignment play a role in ensuring sufficient supply. Within distribution, inventory management and transport logistics determine how effectively medicines are moved through depots to facilities.
It is also important to recognise that these stages are interconnected. Delays or inefficiencies at one point in the system can have downstream effects. For example, late regulatory approval may delay procurement eligibility, while disruptions in manufacturing or delivery can affect depot stock levels and facility availability.
Efforts to improve medicine access in South Africa increasingly focus on strengthening coordination across these stages. Digital systems, improved data visibility, and alignment between regulatory and procurement processes are part of ongoing initiatives aimed at enhancing system performance.
Understanding the journey from prescription to patient provides context for how medicines move through the healthcare system and where targeted improvements can support more consistent availability. While each stage has its own requirements and challenges, the overall objective remains the same: ensuring that safe, effective medicines reach patients in a timely and reliable manner.
References
[1] SAHPRA. Guidelines for Registration of Medicines and Bioequivalence Requirements.
[2] National Department of Health. Essential Medicines List and Standard Treatment Guidelines, South Africa.
[3] Stop Stockouts Project. Stock Visibility System (SVS) Reports and Implementation Findings.