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

• Data exclusivity and registration/patent linkage rules, which in their mostabsolute form can prevent registration of follow-on generic products;• Lack of post-approval quality assurance mechanisms and lack of efficientsupervision of the marketing of medicine to prevent the use of substandardor counterfeit medicines 1 ; and• Lack of a global, up-to-date, accessible registry on registration status of HIV/AIDS medicines.In addressing these myriad problems, both international and national authoritiesbear responsibility to expedite and rationalize the assessment and registrationof lifesaving medicines. In this regard, this section of the report considers theperformance of key international institutions, including WHO, UNITAID, PEPFAR, theClinton Foundation, and others, to highlight areas of progress and further work tobe done. In addition, this chapter highlights key regulatory reforms needed at thelocal level to ensure that PLWHA receive good quality medicines.The perverse registration practices of innovator pharmaceutical companiesThe current regulatory regime for country-by-country registration of medicinesprovides few if any incentives or requirements for drug companies to register newmedicines in a particular market other than the purely profit-driven motive ofwhether registration will be worth the time, effort, and money (Morocco, China).As the report from Morocco states, drug companies do not register their new HIV/AIDS medicines in smaller markets or in countries with small numbers of PLWHA.Accordingly, the country reports indicate that atazanavir (ATV), tenofovir (TDF),emtricitabine (FTC), lopinavir (LPV), ritonavir (r), and efavirenz + emtricitabine+ tenofovir (Atripla), some of the most important, newer first- and second-linemedicines, are currently not registered separately or as appropriate combinations,in most countries. 21 The term “counterfeit medicine” does not apply to legitimate generic equivalents of innovatordrugs, but is limited to medicines that are deliberately and fraudulently mislabeled, that often donot contain any or the correct amounts of active ingredients and expedients claimed, and that aretherefore dangerous and/or ineffective for patients.2 Abbott claims that its Kaletra capsule has been registered in 118 countries, and that it has filedfor registration in 135 countries for Aluvia tablets and had obtained 89 approvals as of June 2007.Abbott claims it will seek to register Aluvia in over 150 countries. Just this November, Gileadposted country-by-country registration status of TDF (tenofovir - Viread®) and TDF/FTC (tenofovir/emtricitabine - Truvada®) in its International Access Operations. See http://www.gilead.com/pdf/GAP_Registration_Status.pdf. As of November 13, 2007, TDF had been approved in 43countries, been filed in another 35, but not filed in 51; TDF/FTC has been approved in 36 countries,filed in 34, and pending submission in 59. It should clearly become an industry standard thatcompanies list country-by-country registration status on a publicly accessible website.50