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

Lack of post-approval quality assurance and regulation of medicinesSome countries report that the drug regulatory system in their country is simply toolax, resulting in a lack of government accountability. In other contexts, the problemis not all-pervasive, but is instead limited to weaknesses in post-approval qualityassurance (Belize). Although there are some examples of regional cooperation inquality assurance (Belize) or of procurement agents providing such services on acontract basis (Nigeria/Axios) and as part of a bilateral initiative (US SCMS), ingeneral quality assurance programs seem weak. Given the critical importanceof ensuring that people receive good quality medicines, major efforts should beundertaken at the multilateral, regional, and national level to prevent formaland informal marketing of counterfeits and substandard, expired, or degradedmedicines. Developing countries should commit substantially more of their existingregulatory capacity to quality assurance, and people living with HIV/AIDS shouldreceive more treatment literacy on the danger of obtaining medicines fromunofficial sources.It is important to note that the US and its key trading partners– including Canada,the European Union (with its 27 Member States), Japan, Korea, Mexico, NewZealand, and Switzerland– have started negotiations on an Anti-CounterfeitingTrade Agreement 6 . Although counterfeiting and substandard medicines are certainlyan important issue for developing countries, there are reasons to suspect that themotivation for this new focus on counterfeits is at least partially to attack the qualityof generic production and to seek even stronger IPR-enforcement, border-control,product-tracing, and anti-diversion measures in future trade agreements.Lack of a global, up-to-date, accessible registry on registration status ofHIV/AIDS medicinesAs is true with patents, there is an appalling lack of transparency on a globalscale concerning the registration status of ARVs and OI medicines. With rareexceptions, innovator drug companies don’t list up-to-date registration status onpublicly accessible websites–-nor for that matter do generic producers. Likewise,governments are often non-transparent, although Uganda is an exception, sinceit publishes a national drug-registration list on a monthly basis. It is unsurprisingthat ITPC researchers had such a hard time accessing ARV registration data in theirhome countries and that, even at this date, civil society does not have access toverified information.6 Office of the US Trade Representative. “Ambassador Schwab Announces U.S. Will Seek NewTrade Agreement to Fight Fakes.” October 23, 2007. http://www.ustr.gov/Document_Library/Press_Releases/2007/October/Ambassador_Schwab_Announces_US_Will_Seek_New_Trade_Agreement_to_Fight_Fakes.html?ht=57