Procurement, Regulation and Enforcement

Most medicine procurement and regulation occur at the local or national level, and are tailored to the supply chain and regulation system of each country. These processes are influenced by international procurement and regulation policies created by international agencies and donors. Many organizations have adopted the standards set forth by the WHO Global Malaria Programme guidelines on good procurement practices for ACTs and monotherapies. The WHO system uses two methods to ensure medicine quality: the WHO Prequalification Program (WHO PQP) and the Stringent Regulatory Authority (SRA). In the WHO PQP system, manufactures are invited to submit an expression of interest (EOI) for producing medicines, which are then evaluated by WHO PQP personnel using a standard product assessment. Findings are then publicized on its website. Using SRA protocol, regulatory professionals register a product for a limited time and then reassess it at a later date. Many large donors only procure medicines that have gone through the WHO PQP, SRA or national food and drug administration processes.

Furthermore, the Convention against Counterfeiting of Medicines and Devices, also known as the Medicrime Convention, was set in place in January 2016. The convention, signed by 23 representatives, makes medicine falsification a crime and allows agencies to prosecute people convicted of falsification. For more information, review the treaty or this infographic, displayed here.  

International agencies, like WHO, are not able to investigate criminals or enforce drug policies. To fill the gap, the United Nations Office on Drugs and Crime (UNODC), World Customs Organization (WCO) and Interpol have drafted recommendations, including sample legislation, for country stakeholders to adopt so they can prevent the manufacturing and selling of SSFFC medicines, and punish people who participate in these activities.

Interpol is an international organization that supports police coordination and cooperation around the world. Their Pharmaceutical Crime Program investigates networks of pharmaceutical crime and has been involved in a number of medicine seizures, arrests and convictions.