Billions of people still lack access to essential medicines. This problem disproportionately affects people in low-income countries. The World Health Organization¿s Prequalification of Medicines Programme plays a critical role¿ particularly in low- and middle-income countries¿in ensuring that drugs used in the treatment of priority health conditions, such as HIV and tuberculosis, meet minimum quality standards. However, the Prequalification Programme faces two glaring shortfalls. First, manufacturers whose drugs are denied prequalification are unable to challenge such a decision, raising international due process concerns. Second, nearly all of the prequalified drugs have been produced in middle- and high-income countries, rather than the low-income countries most in need. This Comment proposes that the WHO address these concerns by creating an independent review panel before which manufacturers may challenge adverse decisions, as well as an additional approval pathway available to manufacturers in low-income countries, aimed at facilitating production in these countries.
Process Is Due: The World Health Organization Prequalification of Medicines,
Emory L. J.
Available at: https://scholarlycommons.law.emory.edu/elj/vol68/iss3/5