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

Capacity issues and delays in the WHO Prequalification ProgrammeAs stated previously, the WHO Prequalification Programme is one of the brightlights in the global registration architecture, but it is far from perfect (Malawi).According to the WHO website, the WHO List of Prequalified Medicinal Productslists “medicinal products used for HIV/AIDS, tuberculosis, malaria and otherdiseases, and for reproductive health, which have been assessed as part of theWHO Prequalification Programme and found to be acceptable, in principle, forprocurement by UN agencies.” The Programme focuses on products that arevital to treatment of the specified diseases. Prequalification of medicines requiresevaluation of data relating to quality, safety, and efficacy and inspection of therelevant manufacturing and clinical sites. Alternatively, some products approved bya stringent regulatory authority, like the US FDA, are referenced on the WHO list.The list is updated regularly and the dossier and facility inspection are conducted byhighly qualified technical experts seconded from other drug regulatory authorities. 4The Programme activities are unusually transparent, and it discloses both productsapproved, a list of dossiers awaiting approval, and detailed non-proprietaryinformation in its Public Inspection Reports.The major problem at the Programme is insufficient capacity resulting in delays inprequalification. Although 142 ARVs have been approved, earlier approvals tookmany months (e.g. Cipla’s Lamivir [generic lamivudine (3TC)]: 19 months; Aspen’sstavudine [d4T]: 22 months; Strides’ lamivudine [3TC]/ stavudine [d4T]: 15 months);fortunately the process has speeded up since. Many of the more recent, quickerapprovals have been for medicines that had already been assessed by stringentregulatory authorities. Despite this more streamlined process and the growingfamiliarity of manufacturers with WHO prequalification, there are still 174 productsawaiting approval as of October 29, 2007, including several important genericequivalents of Atripla (EFV + TDF + FTC), heat-stable Kaletra (LPV/r), tenofovir(TDF), and Truvada (TDF + FTC).Fortunately, UNITAID committed $1 million to WHO Prequalification in 2006 and isexpected to contribute an additional $6 million for 2007. Unfortunately, even thisamount is insufficient to rapidly reduce the backlog of pending files.Duplication in the US FDA “fast-track” approval systemThe US fast-track approval system was set up within the US FDA to grant tentativeapproval for purposes of purchases with funds made available by the President’sEmergency Plan for AIDS Relief (PEPFAR). AIDS activists had major criticisms of thefast-track procedures when they were set up because they seemed unduly4 Including: Argentina, Bangladesh, Brazil, Canada, China, Cuba, Denmark, Estonia, Ethiopia,Finland, France, Germany, Hungary, India, Italy, Latvia, Malaysia, Mexico, Netherlands, Pakistan,Philippines, South Africa, Spain, Sweden, Switzerland, Tanzania, Uganda, United States of America,and Zimbabwe.55