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

CHINAThe current process for registration of drug donations for unregisteredARVs or other essential medicines (such as FDCs for treatment of HIV and/or TB) is rigid and inflexible. Technically such donations are not permitted,but they have taken place on a case-by-case basis and only with special“waivers.”The requirement that companies submit production information along withclinical trial data has caused originator companies to delay or hesitate toregister new ARVs. Originator companies say they fear that productioninformation would be shared with local generic companies.Originator companies are not motivated to register and distribute theirARVs in China due to the small commercial market at present—only about39,000 people were on ART as of October 2007, the vast majority ofthose on free first-line ARVs. In particular, many newer or more expensiveARVs never enter the China market (although some are registered toprevent generic production but not actually marketed in China).In August 2007, new regulations for drug registration were issued. Despite therelease of a draft version of the regulations and many suggestions made by NGOsworking on treatment access, fundamental problems remain with the regulationsthat will impact the availability of newer or cheaper ARVs. Those problems includethe following:There is a lack of clear “fast-track” approval procedures for medicines totreat HIV infection and other diseases.There is a lack of clear requirements for approval of generic medicines.In particular, there is lingering uncertainty as to whether clinical trialsare necessary, or whether bioequivalence data only will suffice for suchapproval.Data exclusivity provisions go beyond TRIPS requirements, thereby creatingbarriers to timely registration of generic drugs. Especially considering thefact that originator companies often patent and register but fail to marketnewer drugs, use of this data in assessing generic ARVs is particularlyimportant.Faced with only a handful of ARVs to choose from, many patients and eventreatment providers are forced to turn to personal contacts outside of China tosecure newer or second-line ARVs. Medicines such as tenofovir and lopinavir/ritonavir have been carried in by hand from Africa and countries including India,the United States (mainly private donations), Hong Kong, and Thailand. However,there is no sustainable supply chain system in place in China.71