Medicines

Counterfeit medicines

Fact sheet revised
14 November 2006

Counterfeit medicines are part of the broader phenomenon of substandard pharmaceuticals – medicines manufactured below established standards of quality and therefore dangerous to patients’ health and ineffective for the treatment of diseases. The difference is that counterfeits are deliberately and fraudulently mislabeled with respect to identity or source. Counterfeiting occurs both with branded and generic products and counterfeit medicines may include products with the correct ingredients but fake packaging, with the wrong ingredients, without active ingredients or with insufficient active ingredients.

A global public health crisis

Counterfeit medicines represent an enormous public health challenge. Anyone, anywhere in the world, can come across medicines seemingly packaged in the right way, in the form of tablets or capsules that look right, but which do not contain the correct ingredients and, in the worst case scenario, may be filled with highly toxic substances. In some countries, this is a rare occurrence, in others, it is an everyday reality.

Counterfeit medicines range from random mixtures of harmful toxic substances to inactive, useless preparations. Occasionally, there can be “high quality” fakes that do contain the declared active ingredient. In all cases, contents of counterfeits are unreliable because their source is unknown or vague and always illegal. Fake drugs can cause harm to patients and sometimes lead to death.

Any kind of product can be and has been counterfeited: expensive lifestyle and anti-cancer medicines, antibiotics, medicines for hypertension and cholesterol lowering drugs, hormones, steroids and inexpensive generic versions of simple pain killers and antihistamines. In developing countries the most disturbing issue is the common availability of counterfeited medicines for the treatment of life-threatening conditions such as malaria, tuberculosis and HIV/AIDS.

Counterfeit medicines can harm and kill

The regular use of substandard or counterfeit medicines can lead to therapeutic failure or drug resistance. In some cases, it can lead to death.

  • During a meningitis epidemic in Niger in 1995, more than 50,000 people were inoculated with fake vaccines resulting in 2500 deaths. The vaccines were received as a gift from a country which thought they were safe.
  • 89 children died in Haiti in 1995 and 30 infants died in India in 1998 due to the consumption of paracetamol cough syrup prepared with diethylene glycol (a toxic chemical used in antifreeze).
  • In 2001, in South-East Asia, a Wellcome Trust study revealed that 38% of 104 anti-malarial drugs on sale in pharmacies did not contain any active ingredients.
  • In Cambodia, in 1999, at least 30 people died after taking counterfeit anti-malarials prepared with sulphadoxine-pyrimethamine (an older, less effective anti-malarial) which were sold as artesunate.

A case in Argentina: In 2004, fake medicine led to a trail of death in Argentina. Veronica Diaz was a healthy 22 year old woman, living in Viedma, Argentina, who had mild anaemia caused by insufficient iron in her blood and required her to receive iron injections. In December of 2004, she became very sick and died of liver failure after receiving the 7th of a 10 injection treatment. The medicines authority of Argentina, ANMAT, determined that she had been given a highly toxic counterfeit. Authorities were unable to determine the source of the counterfeit product due to falsified paper work. While most of the counterfeit production throughout Argentina was recovered and four persons were prosecuted, the highly fragmented distribution system prevented the recall from being 100% successful. In May of 2005 another woman died and a 22 year old pregnant woman was injected with the same counterfeit. She survived but gave birth to a 26 week premature baby. To date, Argentinean law does not consider counterfeiting medicines a crime.

Estimates

The US based Centre for Medicines in the Public Interest predicts that counterfeit drug sales will reach US$ 75 billion globally in 2010, an increase of more than 90% from 2005.

Although precise and detailed data on counterfeit medicines is difficult to obtain, estimates range from around 1% of sales in developed countries to over 10% in developing countries, depending on the geographical area. That range takes into consideration both regional disparities in the presence of counterfeits, and specific global market value shares. Apart from the huge differences between regions, variations can also be dramatic within countries, i.e. city versus rural areas, city versus city.

Currently, the sources of information available include reports from non-governmental organizations, pharmaceutical companies, national drug regulatory and enforcement authorities, ad hoc studies conducted on specific geographical areas, and occasional surveys.

Counterfeiting is greatest in those regions where the regulatory and legal oversight is weakest.

  • Most industrialized countries with effective regulatory systems and market control (e.g. USA, most of EU, Australia, Canada, Japan, New Zealand) have a low proportion, i.e. less than 1% of market value
  • Many countries in Africa and parts of Asia and Latin America have areas where more that 30% of the medicines on sale can be counterfeit, while other developing markets have less than 10%; overall, a reasonable range 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 physical address are counterfeit in over 50% of cases.

Internet sales

In industrialized countries and to some extent in poorer countries, Internet-based sales of pharmaceuticals are a major source of counterfeit medicines, threatening those who seek cheaper, stigmatized or unauthorized treatments. Some Internet pharmacies are completely legal operations, set up to offer clients convenience and savings. They require patient prescriptions and deliver medications from government licensed facilities. Illegal Internet pharmacies sell medications without prescriptions and use unapproved or counterfeit products. In some cases, Internet pharmacies are operated internationally and sell products that have an unknown or vague origin.

Counterfeiting grows more sophisticated

Trade in fake medicines is more prevalent in countries with weak drug regulation and enforcement, scarcity or erratic supply of basic medicines, unregulated markets and unaffordable prices. But as counterfeiting becomes more sophisticated, these products are increasingly present even in better controlled markets.

  • In January 2006, the United States Food and Drug Administration (FDA) issued an alert about fraudulent flu remedies, including counterfeit prescription oseltamivir (Tamiflu) medication.
  • The Dutch Healthcare Inspectorate warned consumers in early 2006 not to buy Tamiflu through the Internet, after counterfeit capsules were found in the Netherlands containing lactose and vitamin C, and no active substance. In the United Kingdom, officials seized 5000 packets of counterfeit Tamiflu in early 2006, estimated to be worth £500 000.
  • A recent study in The Lancet concluded that up to 40% of products labeled as containing artesunate(anti-malarial) contain no active ingredients and therefore have no therapeutic benefits. That study showed that counterfeiters' ability to reproduce holograms and other sophisticated printing techniques had dramatically improved between 2001 and 2005, making detection even more difficult.
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