who medicines strategy - libdoc.who.int - World Health Organization

COMPONENTS OF THE STRATEGY | 95Work carried out by WHO in 2001 showed that counterfeit andsubstandard medicines continue to be a major concern globally. Specificproblems included the wrong level or absence of the active ingredient.In Cambodia, for example, 50% (115/230) of samples of 24 differentpharmaceutical products collected from the market were unregistered.Laboratory tests based on registration status showed that of 98 importedregistered products, 6 (6%) failed the laboratory test. Results of testson 112 imported but unregistered products showed that in 22% of thesamples the active ingredients were lower than the amount indicated bythe label. The overall failure rate for the total of 230 samples was 13%.Studies such as these serve as a starting point for formulating nationalstrategies for fighting counterfeit drugs.(Annual Report 2001 – Essential Drugs and Medicines Policy: Extending theEvidence Base, Geneva, WHO, 2002).The production and distribution of medicinesrequires public oversight and stewardship. Unlikeordinary goods and services, an unregulatedmedicines market place will fail: it will be notonly inequitable, but also inefficient and probablydangerous to public health. 49The three main components of stewardship in themedicines market are:> Product registration: assessing and authorizingproducts for market entry, based on quality,safety, and efficacy; and monitoring theirquality and safety after entry.> Regulation of manufacturing, importation, anddistribution.> Regulation of medicine information andpromotion.Most countries have a medicines regulatoryauthority and formal requirements for registeringmedicines. However, medicines regulatoryauthorities differ substantially in their humanand financial resources and capacity. One-thirdof WHO Member States have no medicinesregulatory authority, or at best very limitedcapacity for regulation of the pharmaceuticalmarket. Regulatory gaps are common, withthe informal sector for medicines supply oftenneglected.The quality of medicines varies greatly,particularly in low- and middle-income countriesWHO has been active in supporting countriesin their efforts to assure the quality of products,particularly in response to the increasingavailability of affordable HIV/AIDS medicines. InMarch 2001, WHO launched a project to developa system for the prequalification of manufacturersof ARVs, including both innovator and genericproducers. Working closely with the InternationalPharmaceutical Coordination group (IPC),comprising WHO, UNICEF, UNAIDS, UNFPA,and the World Bank, WHO established consensuson the product standards to be met by suppliers inorder to gain prequalification status, and on theneed to establish a list of prequalified HIV/AIDSmedicines and their suppliers. 50 The system hasnow been expanded to include a prequalificationprocess for TB and malaria medicines and theirsuppliers.Other elements in a comprehensive programme topromote access to quality medicines for HIV/AIDSand other priority health problems have included: