Healthy Skepticism Library item: 7089

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Publication type: report

WHO
Counterfeit Medicines: an update on estimates
2006 Nov 15
http://www.who.int/medicines/services/counterfeit/impact/TheNewEstimatesCounterfeit.pdf

Abstract:

For the past few years the public opinion and expert circles have passively accepted the argument that 10% of medicines around the world could be counterfeit. This number however, is not supportable, because this figure fails to reflect the wide range in the proportion of counterfeits across countries and because of the difficulties in measurement that allow only inferences to be made about the potential range of proportion in different regions.

Today, our capacity to collect and analyse available information has improved, providing a better understanding of the situation through initiatives such as the IMPACT, with input from WHO, OECD, IFPMA, the Pharmaceutical Security Institute and others. We feel that an effort to assess the presence of counterfeiting is fundamental, but also that the old 10% estimate needs to be clarified.

According to the WHO, a counterfeit medicine is “a medicine, which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging.”

Certain countries have translated this definition into their legislation.
The WHO’s definition encompasses all the different legal definitions we have identified so far. We consider consistent with the WHO’s definition all national legislation that translates “deliberately and fraudulently mislabelled” into “if a product contain less than xx% of the declared active ingredient is considered counterfeit”.

We advise against using a single average figure for global proportion of counterfeit medicines because, besides being necessarily imprecise (i.e. not reproducible in subsequent studies) and inaccurate (i.e. not reflecting the actual value), a single global ratio blurs the real picture and can mislead the public.

Instead, it is necessary to use a range when describing the relevance of counterfeiting, along with the development status of countries affected.
Thus, it is reasonable to estimate that the prevalence of counterfeit medicines ranges from less than 1 percent of sales in developed countries, to over 10 percent in developing countries, depending on the geographical area. This range takes into consideration both regional disparities in the presence of counterfeits, and specific global market value shares. (1)

Analysis shows that counterfeiting is greater in those regions where regulatory and legal oversight is weaker, and therefore: – most developed countries with effective regulatory systems and market control (e.g. USA, EU, Australia, Canada, Japan, New Zealand) currently have a very low proportion, i.e. less than 1% of market value. However, we must keep in mind that indications point to an increase in the prevalence of counterfeit medicines even in developed countries; – many developing countries of Africa, parts of Asia, and parts of Latin America have areas where more that 30% of the medicines on sale can be counterfeit. Other developing markets, however, have less than 10%; overall, a reasonable estimate is between 10% and 30%; – many of the former Soviet republics have a proportion of counterfeit medicines which is above 20% of market value -this falls into the developing country range; – medicines purchased over the Internet from sites that conceal their actual physical address are counterfeit in over 50% of cases.

Apart from the huge differences between regions, variations can also be dramatic within countries city versus rural areas, city versus city, and can even be time sensitive – sometimes counterfeits are openly sold and sometimes not.

The sources of information, of course, also underlie the complexity of any estimation. Detailed data on counterfeit medicines is often difficult to obtain or to publish. How to measure a market that, by nature, is informal and illegal -and where evidence is usually consumed?

Counterfeiters and their allies know they are committing a crime and aggressively seek to avoid detection. They engage in elaborate conspiracies to disguise their activities as the masters remain in the shadows. They establish fictitious businesses and front companies. They exploit weaknesses in border control whenever governments try to promote world commerce by reducing border inspections.
They use false documents to obtain essential active pharmaceutical ingredients, as well as manufacturing equipment to replicate genuine products. In sum, their actions disguise the extent of crime and makes detection and reporting extremely difficult.
Currently, the sources of information available include reports from national authorities, such as drug regulatory and enforcement agencies, ad hoc studies conducted on a specific geographical area or therapeutic category, reports from the pharmaceutical sector, reports from NGOs and surveys.

In summary, the estimated range does not aim at providing an exact figure but rather an indication of the different possible levels of prevalence around the world. Even one single case of counterfeit medicine is not acceptable because, in addition to putting patients at risk and undermining the public confidence in their medicines, it also betrays the vulnerability of the pharmaceutical supply system and jeopardizes the credibility of national authorities (health and enforcement alike).

1 Global pharmaceutical market shares are 83% for developed markets, and 17% for developing world. Based on audited IMS sales data, 2005 publicly available at
http://www.imshealth.com/ims/portal/front/articleC/0,2777,6599_77478579_7747
9643,00.html

Keywords:
safety efficacy generics information government agencies developing countries