Missing the Target #5: Improving AIDS Drug Access ... - CD8 T cells

DRUG REGISTRATION BARRIERS & LOGJAMS49By Brook K. Baker, Health GAPIn order for people living with HIV/AIDS to access lifesaving medicines and to berelatively assured that the medicines they are receiving are safe, effective, andof good quality, antiretroviral and OI medicines must be evaluated by competentauthorities. The global and national architecture for this regulatory process isextraordinarily complex and, as the country reports indicate, the process is fraughtwith disharmonies, inefficiencies, duplications, delays, and in some instances,corruption.This section of the report highlights the multiple areas of concern that can beclassified within the following broad categories:• Lack of incentive mechanisms or regulatory systems that encourage orcompel innovator companies to promptly register their medicines for use insmaller and poorer countries with resulting long delays in access to newermedicines;• Lack of sufficient incentive mechanisms, technical assistance, or othermeasures that encourage or compel generic companies to promptly registertheir therapeutic equivalents for use in smaller and poorer countries;• Absence of fast-track registration procedures in most countries to permitexpedited registration of medicines that have been accepted by the WHOPrequalification Programme or registered by a stringent regulatory authorityin another country;• Absence of efficient special authorization procedures that allow automaticmarketing of important medicines that have been accepted by the WHOPrequalification Programme or registered by a stringent regulatory authorityin another country while the formal registration process is being completed;• Insufficient capacity, inefficiency, high fees, and occasional corruption innational drug regulatory authorities that create delays and disincentives toboth innovators and producers of generic equivalents;• Insufficient capacity and delays in the WHO prequalification system thatresult in delayed registration of newer medicines;• Duplication of effort by the United States Food and Drug Administration(FDA) and the “fast-track” tentative approval system required by thePresident’s Emergency Plan for AIDS Relief (PEPFAR), which does not allowpurchase of medicines accepted by the WHO Prequalification Programme;