The U.S. Agency for International Development (USAID) Office of HIV/AIDS (OHA) has developed a comprehensive package of prevention, care, and treatment programs in response to the global HIV/AIDS crisis in developing countries. Many of the OHA-supported programs involve the use of pharmaceutical products including drugs, HIV test kits, and other supplies to diagnose, prevent, and treat HIV/AIDS and related conditions.

As the HIV/AIDS crisis has expanded, so have requests from cooperating agencies (CAs) and USAID Missions to purchase pharmaceutical products, but these purchases require adherence to USAID regulations and guidelines. Many USAID Missions and CAs have found it difficult and time-consuming to prepare the supporting documentation needed to meet these source/origin and safety, efficacy, and quality requirements.

In 2000, USAID asked RPM Plus for assistance in reviewing the guidelines and procedures for USAID-funded procurement of HIV/AIDS-related pharmaceutical products. A major finding was the need for guidance material to help Missions and CAs prepare requests for USAID approval to procure HIV test kits and HIV/AIDS-related pharmaceutical products. The lack of readily accessible information on the process meant the use of USAID funding was often impeded.

RPM Plus has developed two documents to assist USAID Missions and CAs in identifying procurement sources and to provide guidance on procedures for USAID-funded procurement of HIV/AIDS-related pharmaceutical products:

• Requesting USAID Approval to Procure HIV Test Kits and Other HIV/AIDS-Related Pharmaceutical Products: Guidance and Sources of Information.
   
  This resource and reference document is designed to provide guidance in the completion of submitted requests and reduce the time needed to prepare and process them. The guide defines and details the elements of the approval process and outlines the specific responsibilities and roles of the various organizations and officials involved in procurement.
   
  
• HIV Test Kits Listed in the USAID Source and Origin Waiver: Procurement Information Document.
   
  This resource and information guide serves to facilitate the process of procuring the HIV test kits listed in Tab 1 (Approved List of Testing Kit Products and Manufacturers) of the USAID Source and Origin Waiver.