Background information on counterfeit medicines

What is a “counterfeit medicine”?

In its 2003 Statement of Policy on Counterfeit Medicines, FIP adopted the 1992 WHO definition of a counterfeit medicine, that is to say: “the deliberate and fraudulent mislabelling with respect to the identity, composition and/or source of a finished medicinal product, or ingredient for the preparation of a medicinal product. Counterfeiting can apply to both branded and generic products and to traditional remedies. Counterfeit products may include products with the correct ingredients, wrong ingredients, without active ingredients, with insufficient quantity of active ingredient or with false or misleading packing; they may also contain different, or different quantities of, impurities both harmless and toxic”.

This definition was officially endorsed at a meeting in Geneva (1-3 April 1992), which gathered experts from governmental institutions of WHO member states, INTERPOL, the World Customs Organization (formerly the Customs Cooperation Council), the International Narcotics Control Board, the International Federation of Pharmaceutical Manufacturers & Associations, the International Organization of Consumer Unions, and the International Pharmaceutical Federation (FIP).

 

Global view of the problem including reference to WHO data

Counterfeit medicine is a global issue. According to recent WHO estimates:1

  • Most developed countries with effective regulatory systems and market control (e.g. USA, EU, Australia, Canada, Japan, New Zealand) currently have a low proportion of counterfeit medicines (i.e. < 1% of market value). However, 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 over 30% of the medicines on sale can be counterfeit. Other developing markets 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 above 20% of market value, falling into the developing country range;
  • 50% of medicines bought over the internet from sites that conceal their actual physical address are counterfeit.

In fact, all markets are affected by counterfeit medicines, with developing countries (in Africa, Asia and Latin America) being the first victims.

In 2013, as part of Interpol’s Operation Giboia, some 550 coordinated raids and inspections of marketplaces, pharmacies and clinics as well as illicit care centres and outlets took place in around 30 cities and border points in Angola, Malawi, Swaziland, Tanzania and Zambia. Almost 100 tonnes of illicit and counterfeit medicines were seized, most being antibiotics, birth control pills, antimalarials and analgesics, both branded and generic. 

With regards to internet sales, over 9.6 million counterfeit and illicit medicines were seized by Interpol’s Operation Pangea in 2014. These products were for a number of areas, from cancer, malaria and high cholesterol to erectile dysfunction, coughs and colds, and slimming.

What are the consequences?

Reported consequences of counterfeit medicines include:

  •  2,500 child deaths during a meningitis outbreak due to the lack of protection given by fake vaccines in Niger (1995).1
  • Over 100 deaths (mostly children) after a counterfeit syrup containing diethylene glycol was used in Panama (2006).

Further examples of “spurious/falsely-labelled/falsified/counterfeit” (SSFC) medicines include:2

 

SFFC medicine

Country & year

Report

Avastin (for cancer treatment)

 USA, 2012

Affected 19 medical practices. The drug lacked active ingredient

Viagra and Cialis (for erectile dysfunction)

 UK, 2012

Smuggled into the country and contained undeclared active ingredients with possible serious health risks to the consumer.

Truvada and Viread (for HIV/AIDS)

 UK, 2011

Seized before reaching patients. Diverted authentic product in falsified packaging.

Zidolam-N (for HIV/AIDS)

 Kenya, 2011

Nearly 3,000 patients affected by falsified batch of antiretroviral therapy.

Alli (weight-loss medicine)

 USA, 2010

Smuggled into the country and contained undeclared active ingredients with possible serious health risks to the consumer.

Antidiabetic traditional medicine

 China, 2009

Contained six times the normal dose of glibenclamide. Two people died, nine were admitted to hospital.

Metakelfin (antimalarial)

 Tanzania, 2009

Discovered in 40 pharmacies. The drug lacked sufficient active ingredient.


References 

This is why FIP has been involved for over 20 years in the fight against counterfeit medicines to protect patients for the related dangers. Such a global issue needs a joint and strong answer from all relevant stakeholders. For information on related FIP activities and publications click here.

1. World Health Organization - IMPACT. Counterfeit Medicines: an update on estimates, 15 November 2006. Available at: www.who.int/medicines/services/counterfeit/impact/TheNewEstimatesCounterfeit.pdf. (Accessed 6 November 2008).

2. World Health Organization. Medicines: spurious/falsely-labelled/ falsified/counterfeit (SFFC) medicines, Fact sheet N°275. May 2012. Available at: www.who.int/mediacentre/factsheets/fs275/en/ (Accessed 11 November 2014).

 

Updated 18 November 2014