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Counterfeit Medicines: an update on estimates - World Health ...

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Apart from the huge differences between regi<strong>on</strong>s, variati<strong>on</strong>s c<str<strong>on</strong>g>an</str<strong>on</strong>g> also be dramatic within countries -city<br />

versus rural areas, city versus city-, <str<strong>on</strong>g>an</str<strong>on</strong>g>d c<str<strong>on</strong>g>an</str<strong>on</strong>g> even be time sensitive – sometimes counterfeits are openly<br />

sold <str<strong>on</strong>g>an</str<strong>on</strong>g>d sometimes not.<br />

The sources of informati<strong>on</strong>, of course, also underlie the complexity of <str<strong>on</strong>g>an</str<strong>on</strong>g>y estimati<strong>on</strong>. Detailed data <strong>on</strong><br />

counterfeit medicines is often difficult to obtain or to publish. How to measure a market that, by nature, is<br />

informal <str<strong>on</strong>g>an</str<strong>on</strong>g>d illegal –<str<strong>on</strong>g>an</str<strong>on</strong>g>d where evidence is usually c<strong>on</strong>sumed?<br />

<str<strong>on</strong>g>Counterfeit</str<strong>on</strong>g>ers <str<strong>on</strong>g>an</str<strong>on</strong>g>d their allies know they are committing a crime <str<strong>on</strong>g>an</str<strong>on</strong>g>d aggressively seek to avoid detecti<strong>on</strong>.<br />

They engage in elaborate c<strong>on</strong>spiracies to disguise their activities as the masters remain in the shadows.<br />

They establish fictitious businesses <str<strong>on</strong>g>an</str<strong>on</strong>g>d fr<strong>on</strong>t comp<str<strong>on</strong>g>an</str<strong>on</strong>g>ies. They exploit weaknesses in border c<strong>on</strong>trol<br />

whenever governments try to promote world commerce by reducing border inspecti<strong>on</strong>s. They use false<br />

documents to obtain essential active pharmaceutical ingredients, as well as m<str<strong>on</strong>g>an</str<strong>on</strong>g>ufacturing equipment to<br />

replicate genuine products. In sum, their acti<strong>on</strong>s disguise the extent of crime <str<strong>on</strong>g>an</str<strong>on</strong>g>d makes detecti<strong>on</strong> <str<strong>on</strong>g>an</str<strong>on</strong>g>d<br />

reporting extremely difficult.<br />

Currently, the sources of informati<strong>on</strong> available include reports from nati<strong>on</strong>al authorities, such as drug<br />

regulatory <str<strong>on</strong>g>an</str<strong>on</strong>g>d enforcement agencies, ad hoc studies c<strong>on</strong>ducted <strong>on</strong> a specific geographical area or<br />

therapeutic category, reports from the pharmaceutical sector, reports from NGOs <str<strong>on</strong>g>an</str<strong>on</strong>g>d surveys.<br />

In summary, the estimated r<str<strong>on</strong>g>an</str<strong>on</strong>g>ge does not aim at providing <str<strong>on</strong>g>an</str<strong>on</strong>g> exact figure but rather <str<strong>on</strong>g>an</str<strong>on</strong>g> indicati<strong>on</strong> of the<br />

different possible levels of prevalence around the world. Even <strong>on</strong>e single case of counterfeit medicine is<br />

not acceptable because, in additi<strong>on</strong> to putting patients at risk <str<strong>on</strong>g>an</str<strong>on</strong>g>d undermining the public c<strong>on</strong>fidence in<br />

their medicines, it also betrays the vulnerability of the pharmaceutical supply system <str<strong>on</strong>g>an</str<strong>on</strong>g>d jeopardizes the<br />

credibility of nati<strong>on</strong>al authorities (health <str<strong>on</strong>g>an</str<strong>on</strong>g>d enforcement alike).<br />

Annex<br />

2006 Reports<br />

Russia: The Federal Service for <strong>Health</strong> Sphere Supervisi<strong>on</strong> (FSHSS) reported that 10% of all drugs <strong>on</strong> the<br />

Russi<str<strong>on</strong>g>an</str<strong>on</strong>g> market were counterfeit. However, other sources estimate that the real figure could be much<br />

higher.<br />

Nigeria: The Nati<strong>on</strong>al Agency for Food, Drug Administrati<strong>on</strong> <str<strong>on</strong>g>an</str<strong>on</strong>g>d C<strong>on</strong>trol (NAFDAC) <str<strong>on</strong>g>an</str<strong>on</strong>g>nounced that the<br />

prevalence of counterfeit drugs has dropped to 16% at the beginning of 2006.<br />

Reports Before 2006<br />

Dominic<str<strong>on</strong>g>an</str<strong>on</strong>g> Republic: The Public <strong>Health</strong> Department reported that 50% of the pharmacies operate illegally<br />

<str<strong>on</strong>g>an</str<strong>on</strong>g>d that, according to the statistics, 10% of the medicines that arrive in the country are fake. Some of the<br />

medicines found have expired over 10 years ago.<br />

El Salvador: INQUIFAR, the associati<strong>on</strong> of pharmaceutical comp<str<strong>on</strong>g>an</str<strong>on</strong>g>ies in El Salvador, has denounced the<br />

widespread availability of counterfeit drugs <strong>on</strong> the domestic market. According to the local drug-maker<br />

Gamma Laboratorios, the commercializati<strong>on</strong> of counterfeit medicines currently generates ec<strong>on</strong>omic losses<br />

of around $40 milli<strong>on</strong> per year to the country's pharmaceutical industry.<br />

Ind<strong>on</strong>esia: The Internati<strong>on</strong>al Pharmaceutical M<str<strong>on</strong>g>an</str<strong>on</strong>g>ufacturers Group (IPMG) in Ind<strong>on</strong>esia has estimated that<br />

pirated drugs c<strong>on</strong>stitute 25% of Ind<strong>on</strong>esia’s $2 billi<strong>on</strong> pharmaceutical market. According to IPMG’s vice<br />

chairm<str<strong>on</strong>g>an</str<strong>on</strong>g>, those fake drugs hit foreign pharmaceutical comp<str<strong>on</strong>g>an</str<strong>on</strong>g>ies’ bottom lines <str<strong>on</strong>g>an</str<strong>on</strong>g>d pose a potential<br />

serious public health threat.<br />

Kenya: A r<str<strong>on</strong>g>an</str<strong>on</strong>g>dom survey by the Nati<strong>on</strong>al Quality C<strong>on</strong>trol Laboratories (NQCL) <str<strong>on</strong>g>an</str<strong>on</strong>g>d the Pharmacy <str<strong>on</strong>g>an</str<strong>on</strong>g>d<br />

Pois<strong>on</strong>s Board found the almost 30% of drugs in Kenya are counterfeit. According to Dr. Hezekiah<br />

Chepkw<strong>on</strong>y of the NQCL, "Some of the drugs are no more th<str<strong>on</strong>g>an</str<strong>on</strong>g> just chalk or water being marketed as<br />

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