Setting up Systems for Supply Chain Management
No product, no program: making sure that supplies reach PrEP sites
A supply chain is a system that moves a product or service from supplier to customer. To establish a supply chain for PrEP, you should determine the quantity of product you will need. Consider if the PrEP products can be sourced from multiple manufacturers. Multiple sources can bring down costs and ensure reliable supply. The supply chain landscape is dynamic—it’s important to track trends and developments at the global and national levels.
Product Registration
Each manufacturer must register its PrEP product(s) for use in-country, or governments must provide a waiver for their use. Many of the drugs for PrEP are registered for treatment, but some countries require a separate registration or modification specifying an indication for prevention.
- The EECO Product Registration Toolkit from Catalyst Global is a digital collection of adaptable resources to guide the process of registering health products in low- and middle-income countries
- The Registration Module from CHAI’s HIV New Product Introduction Toolkit provides Ministries of Health and implementing partners with tools and resources to register new products for use in-country
Procurement
Countries will need to procure the PrEP products at the lowest possible cost, and select suppliers that ensure timely delivery of quality products. A good demand forecast, a fair bidding process and sufficient funding can contribute to successful procurement.
- WHO Prequalification ensures that key health products meet global standards of quality, safety and efficacy, and is used by UN and other procurement agencies to inform purchasing decisions regarding health products
- The USAID Global Health Supply Chain Program is a collection of eight complementary projects working to achieve stronger, more resilient health supply chains, including the Procurement and Supply Management project, which provides an array of services for commodity procurement, supply, and systems strengthening technical assistance for HIV services
Distribution
A distribution plan outlines how to get PrEP from central storage facilities to prescribers who will in turn get them to users. PrEP can be distributed together with ARVs where delivery channels already exist, but new delivery systems may need to be established to reach facilities that will only dispense PrEP but not ARVs.
- WHO’s Good Storage and Distribution Practices for Medical Products (2020) sets out steps to assist in fulfilling the responsibilities involved in the different stages within the supply chain and to avoid the introduction of substandard and falsified products into the market