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

Recommendations to increase access to second-line ARVs:The government needs to speed up the approval process for tenofovir,possibly getting a temporary approval for the first six-month supply, and itshould start rolling out second-line ART as soon as possible.Second-line ART entry requirements should not include resistance testing(genotyping) because such tests are not widely available in China andtheir absence will prevent most PLWHA from ever accessing second-lineARVs. Clinical and/or virological confirmation of resistance should besufficient to start second-line treatment.Second-line ART should be made available nationally as long as patientsmeet entry requirements and a qualified doctor is monitoring the patient.Treatment education and (preferably) peer-led support and treatmentcounseling should be introduced in all treatment sites.The Chinese government should participate in UNITAID in order to accesscheaper ARVs and to improve its negotiating position with multinationalpharmaceuticals.Drug registrationCHINAOn paper, China has a clear system for new drug registration in place, withapplications being managed by the State Food and Drug Administration (SFDA). Inreality, this system is not working smoothly or quickly enough to ensure that newerand cheaper medicines enter the market. The slow pace of drug registration is amajor barrier to the availability of effective and affordable ART in China. A numberof systemic factors and related causes can be identified, including the following:The complex and slow processing of new drug applications by the SFDAhas created long delays and at times convinced drug manufacturers thatentry into the Chinese market is too cumbersome to be worth the timeand money required.Regulatory agencies have refused to approve domestic applications for theproduction of fixed-dose combinations (FDCs) of first-line ARVs.For years, corruption has been a problem within drug registrationagencies. In early 2007, a high-ranking official within the SFDA wasarrested on corruption charges and subsequently executed. Other officialsreceived jail sentences. The related investigations, and fears among SFDAstaff of future criminal cases, have greatly slowed the processing of newdrug registrations.70