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COUNTERFEITS/
PHARMACEUTICALS
source: www.eubusiness.com/topics/
Trade/piracy.2005-02-09
www.efpia.org/2_indust/
counterfeitdrugs.pdf.
www.wcoipr.org/wcoipr/default.htm?/
wcoipr/Menu_Alliance.htm
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Pharmaceuticals are particularly susceptible to counterfeiting because they are a high profit and low bulk product. Both branded medicines and generic medicines are subject to counterfeiting…- parallel trade in pharmaceuticals involves the importation and sale of medicines from sellers and, often production sites not approved by national regulatory authorities. Unfortunately, substandard and ineffective counterfeit drugs are often available in many developing countries, as they lack well-functioning drug regulatory systems backed up by quality control laboratories. In addition, a major concern is the international trade in counterfeit drugs;
- the magnitude of the problem varies. According to the World Health Organization, between 6% and 10% of medicine on the world market is reported to be counterfeit with estimated sales of over US$35 billion a year. In the South East Asia, in particular, 10% of the total on the market are estimated fakes. About 5-8% of drug products shipped to the United States are counterfeit, unapproved, or substandard. In addition, some analysts have estimated that 50-70% of drugs in developing countries are counterfeit;
- according to the World Customs Organization, organised criminals involved in this global contraband activity are relying on ever more sophisticated techniques to conceal their activities: in some cases, genuine packages are re-used for counterfeit medicines. To confuse retailers and consumers, counterfeit copies are often mixed with grey market products. Some crime groups obtain end-of-life pharmaceuticals and place them in new packages with a new expiry date;
- a recent study by the Spanish Consumers' Association had shown that 1/4 of ‘e-pharmacies’ sold medicines on the Internet illegally. Many counterfeit medicines were repackaged products that had outlasted their original shelf life;
- in the European Union, manufacturers of counterfeit pharmaceuticals have been identified in Italy, German, Greece, Spain and the Netherlands. Outside the EU, China is a major source country for counterfeit medicines;
- in Italy, in July 2000, authorities arrested participants in an international organised criminal enterprise partly based in the country. Nearly 250,000 units of counterfeit medicines were seized together with 2 tons of raw materials. Originated from India and China, the materials were repackaged in Europe for resale in the Americas. This confirms that counterfeit medicines are a global problem;
- in Russia, according to the Ministry of Health, in 2000, the number of reported cases of counterfeit medicines has risen dramatically and constituted 3.6% of the market, especially in ntibiotics. A 2001 study by the Coalition for Intellectual Property Rights (CIPR) and the Association of International Pharmaceutical Manufacturers (AIPM) concluded that some 10% of drugs in Russia were counterfeit;
- Brazil is known for its counterfeit pharmaceuticals and chemicals. Official sources indicate that 1/5 of all branded medications currently sold in Brazil are counterfeit. The National Secretariat of Health estimates that 5 to 7% of all medicines in Brazil are counterfeit. Such examples include: fake penicillin and tetracycline products containing only a small portion of the labelled amount of the antibiotic, or none at all; birth control pills made with wheat, resulting in over 200 reported unwanted pregnancies; (1)
- in many South-East Asian countries approximately 10% of the medicines on the market counterfeit. In Pakistan, estimates about the private sector suggest about 50% of the market being constituted by counterfeit. In Indonesia the average has been estimated to 8%;
- in China, authorities have found that for some products, the estimated average of counterfeit copies can be as high as 50%, reaching 85% for some brands.
- in Nigeria, a survey conducted by the Nigerian Institute of Pharmaceutical Research revealed that 80% of drugs in the major pharmacy stores in Lagos, Nigeria were fake or counterfeit; (2)
- according to the World Customs Organization, counterfeiting and associated activities are estimated to cost the pharmaceutical industry €12.6 billion (US$15.78 billion) a year in worldwide losses.
Taking for granted that the medicines can be trusted, patients, doctors and other medical staff often do not even suspect that there is anything wrong with the pills and tablets…- in a context of high prevalence of infectious diseases, any unusual side-effects (or deaths) are often attributed to other causes;
- counterfeit drugs are also a problem that directly contributes to anti-microbial resistance. A US$21 billion industry, which comprises an estimated 5% of all antibiotics sold worldwide. Resistance flourishes wherever antibiotics are abused, misused and dispensed at levels lower than treatment guidelines dictate. This means that instead of wiping out the infection altogether, medications kill only non-resistant organisms – leaving their tougher counterparts to replicate and spread resistance genes;
- between 1992 and 1994, as many as 51% of counterfeiting cases uncovered by WHO (70% of which were discovered in developing countries) revealed that forged drugs carried no active ingredient whatsoever. Among the counterfeits, yet another 17% contained the wrong ingredient, while an additional 11% contained weaker than recommended concentrations of active medication. Indeed, some of these, so-called ‘medications’ contained poisons capable of causing severe disability or death. Overall, only 4% of counterfeits contained the same quantity and quality of medication as their authentic counterparts;
- up to April 1999, the World Health Organisation (WHO) found more than 771 cases of counterfeit medicines. Some of these had no active ingredients. Others had very small quantities. In the worst cases, the active ingredients had been replaced with fatal poisons;
- the consumption of a counterfeit paracetamol cough syrup resulted in the death of 89 people in Haiti in 1995. Around 2500 people are believed to have died in Nigeria in 1995 after they had been given a false meningitis medicine. An investigation published in The Lancet, showed that in Vietnam and other South-East Asian countries, 38% of an anti-malaria pill did not contain any active drug, leading to the deaths of patients with malaria;
- counterfeit version of the AIDS drug circulated in the United States in late 2000; the drug was not effective and caused skin irritations; (3)
- according to the Shenzhen Evening News (a government owned newspaper), approximately 192,000 people died in China in 2001 because of fake drugs. The same article goes onto to state that, since 2001, Johnson & Johnson has established 38 criminal cases against different factories that copied its products in China. (4)
(1) www.brazilcouncil.org/usermedia/
MediaLibrary/Counterfeiting_and_Piracy_in_Brazil.pdf.
(2) “Nigeria Reaffirms Efforts to Eliminate Fake Drugs”, Xinhua General News Service, February 13, 2003.
(3) The Engineer, “Fighting the Fakers”, April 26, 2002; Jim Shamp, “Glaxo Sends Out Warning About AIDS Drug”, The Herald-Sun, May 14, 2002 (discussing a case of counterfeit labels applied to the wrong type of AIDS drug).
(4) “China’s Killer Headache: Fake Pharmaceuticals”, Washington Post, August 30, 2002.
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