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

WHO undertook to collect and update such information through its AIDS Medicinesand Diagnostic Services (AMDS) mechanism to operate “as a clearing house,collecting and disseminating strategic information. Prices, availability and regulatorystatus of anti-retroviral medicines, technical information of HIV diagnostics andcondoms, are made available to those who need them through the AMDS websiteand by other means of communication.” In particular AMDS promised, concerningregistration and quality assurance to provide “[g]lobal guidance and information onregulatory matters and registration status of ARVs; strengthening drug regulatoryagencies in dealing with ARVs (registration, inspection, importation, local productionand combination products).”There is little evidence that the AMDS has accomplished this task. It last updatedregistration status on its website over two years ago on October, 25, 2005.Accordingly, the data in that document is woefully incomplete. Although it is surelya question of resources and technical capacity, WHO should reinvigorate AMDS sothat it can perform its information and technical assistance promises.ConclusionThe most troubling issue in the country reports is the absence of registration ofkey ARVs, especially newer and second-line therapies that are absolutely essentialto lifesaving treatment. The picture that emergences from the tip-of-the-icebergcountry reports on registration status reveals a product approval system in totaldisarray, with bits of operational coherence overwhelmed by the chaos of failedincentives, failed harmonization, and failed regulatory oversight, both nationallyand internationally. It seems clear that WHO must do much more to fulfill itsfiduciary obligation as the arbiter in international norms on rational use andwidespread availability of lifesaving medicines. It seems clear as well that drugcompanies, innovator and generic, must take their responsibility to register theirproducts much more seriously. Finally, national governments must do much betterin amassing local and regional capacity to assure the quality, safety, and efficacyof medicines and to utilize the efficiencies that are available to them such asreliance on WHO prequalification and/or prior registration by stringent regulatoryauthorities. It turns out that the crisis of access to lifesaving medicines is a crisisof patent-related pricing, registration, and procurement/distribution. Attention toregistration issues has lagged far behind and it is far past the time for economicinterests and policymakers to rectify the mess that they have created.58