Glossary
1. An omnipresent threat
Historically, given the risks of falsification of pharmaceutical products, people have been forced to realize that a drug is unlike other consumer products. Any defect in its quality may cause a patient’s death. On a large scale, the health risks are considerable.
Thus, in the United States and as early as 1820, US Pharmacopeia established the first quality standards governing medicines. This first list included 217 medicinal products which met the criteria "the more fully established and the better understood”. Since that time, all actors involved in the preservation of the safety of populations (Governments, health authorities, pharmaceutical laboratories, pharmacists...) have constantly strived to secure drugs and their supply chain from the manufacturer to the patient.
"One does not die from wearing false handbags or T-shirts. However, drug counterfeiting can kill." Howard Zucker, Assistant Director-General to the WHO.
Despite these efforts, fake medicines have managed to penetrate the system in the United States as everywhere else.
•In 1937, more than 100 Americans died by consuming a counterfeit drug containing diethylene glycol, a powerful solvent.
•In 2006, more than a hundred children in Panama were victims of the same product inserted in a fake cough syrup. The solvent was falsely identified and exported as glycerine, an ingredient which is in the composition of many drugs.
Between these two symbolic dates, 70 years apart, the combination of multiple factors (increasing demand for health care, the globalization of trade, and the access of organized crime to sophisticated mass production technologies …) has contributed to greatly amplifying the phenomenon: the counterfeiting of drugs is now a global pandemic.
2. A widely exceeded alert threshold
Gravity of the facts, magnitude and globalization of the phenomenon, speed of progression of the threat…: whatever the measurement criterion, in the global traffic in fake medicines, all indicators (however imperfect they are) show that the situation is more than critical. In addition, the traffic of fake medicines is by nature a hidden crime and the unofficial figures (i.e. the estimate of the number of crimes unknown to the enforcement authorities) can be considerable.
Health is the most precious asset for mankind because protecting health conditions access to all the other human assets. From this observation has emerged, little by little, the notion of "the right to health".
Also, and contrary to all other forms of counterfeiting, medication counterfeiting directly attacks the physical integrity of people and the very foundations of our societies.
As such, trafficking in counterfeit drugs is an intolerable criminal activity that should be dug out, prosecuted and convicted with the utmost firmness.
-1990, Haiti: a cough solution was diluted with a toxic solvent: 89 dead
-1995, Niger: fake vaccines used in a meningitis epidemic: 2500 dead
-2009, Nigeria: 84 children died after drinking adulterated acetaminophen syrup.
(Source LEEM web site: http://www.leem.org/dossier/falsifications-de-medicaments-10-du-marche-mondial)
-Intensity: The volume of fake drug trafficking has reached an unprecedented level, threatening the global health balance. As with all illegal activities, it is particularly difficult to estimate the extent of trafficking of fake medicines with accuracy.
However, the available figures are sufficiently eloquent:
-1 drug in 10 sold in the world is likely a fake. (FDA)
-counterfeit drugs against malaria and tuberculosis would alone cause 700 000 deaths per year (2009 figures - International Policy Network).
Today, false drug trafficking has reached a historically unprecedented scale. Hundreds of thousands of children, women and men are victims organized criminals’ greed.
-From 6 to 15% of the world medication market may be counterfeited.
-According to the WHO, the global turnover of fake drug trafficking would have reached $ 45 billion in 2006 and $ 75 billion in 2010.
-1 drug in 2 purchased on internet sites who conceal their physical address would be counterfeit or at least non-compliant (WHO)
-In 2009, 7 million doses of fake medicines were seized by European Customs (source European Commission).
-Of the one million deaths per year due to malaria, 200 000 deaths could be avoided if patients were treated with real drugs. (WHO)
-In Africa, rates of falsified medicines vary between 30% and 70% depending on the country (WHO).
-Ubiquity: All countries are affected by drug counterfeiting.
If emerging countries (Africa, South East Asia, South America…) remain the priority target of organized crime and the sale of fake medicines, counterfeit drug trafficking is widespread around the world: no population and no state can claim to be free from the traffic of fake medicines. This includes Europe which is particularly affected by internet sales.
-In 2006, up to 30% of the drugs available in some countries of Asia, Africa and Latin America may have been counterfeit. (IMPACT)
-Rate of counterfeit drugs/total products sold: Russia: 10-12%, Indonesia: 30%, Lebanon: 35%...
-64% of the anti-malarial drugs tested in Viet Nam contain no active principle (Lancet).
Fake drug trafficking is the subject of major studies and systematic surveys over the past decade or so. The number of direct and indirect victims, the frequency and volume of the batches seized in customs, the number of reported incidents, the broadening range of the type and quantity of original medicines (princeps) that are falsified: the progress of all of these indicators shows just how exponential the growth of the phenomenon is. It is also feared that the more we uncover the phenomenon, the more we will realise its magnitude and its development.
Now, all therapeutic drug classes (if not the drugs themselves) are the subject of counterfeiting.
-In 2009, the number of incidents reported by pharmaceutical companies on counterfeiting, diversion or theft of medicines was 2003. That is an increase of 9.2% in one year. (source PSI).
-The 2003 incidents reported in 2009 concerned 808 different pharmaceutical products. That is a broadening of the spectrum of products concerned by 36% in 1 year. (651 products identified in 2008).
3 Issues at stake: the global balance threatened
Counterfeit drugs kill hundreds of thousands of people around the world. Faced with this reality, the central concern is health.
a. Developing countries: A sanitary emergency
Fake drug trafficking hits the populations of emerging countries hardest.Failing health and justice systems, inefficiency of control agencies, shortage of drugs, poverty and lack of information to patients, sometimes corruption...: all of these causes contribute to weakening the least developed countries of Africa, Asia or South America. They are therefore among the countries the most exposed to health risks.
-"Vital" drugs - the traffickers’ preferred targets
The market of counterfeit health products in emerging countries affects in priority the types of drugs used to treat potentially fatal diseases (malaria, AIDS, tuberculosis…) and extends to antibiotics, analgesics, pest control, and blood products.
This characteristic therefore weighs as an additional threat on the inhabitants of emerging countries (it is less the issue in developed countries). Fooled by fake ineffective drugs, individuals falsely believe that they are treated against a serious disease. The absence of an active principle in most counterfeit products or the impurities they contain induce a real risk of treatment failure or of serious collateral accident.
Practiced on a large scale, the proliferation of fake medicines in emerging countries undermines the foundations of health systems, contributing to their discredit in the eyes of the population.
In this way, false drug trafficking hinders the development of the most needy countries.
Long protected against fake drug trafficking in the past, the health product market in Western countries is today exposed to the threat of counterfeiting. In 2006, the WHO estimated that counterfeit drugs accounted for 1% of the health products market in developed countries and the first death officially attributed to the ingestion of a falsified drug was registered in 2007.
Very exposed, patients in the United States suffer from the very large difference in the price of their medicines and those in neighbouring countries. Furthermore, traffickers exploit the loopholes of a system which manifests major social and income disparities. (SOURCE LEEM - Guide to the use of pharmacists, page 4)
Moreover, poor social coverage and reimbursement of care encourage Americans of the popular classes to take the risk of buying counterfeit, less expensive drugs. These risky purchases are facilitated by internet sales.
The phenomenon is becoming a forefront matter of concern for U.S. authorities.
-in 5 years, drug counterfeiting has multiplied by a factor of almost 10 (http://www.leem.org/article/contrefacon-dans-les-pays-industrialises).
-in 2008, the U.S. health agency, the Food and Drug Administration (FDA), opened 58 investigations relating to the counterfeiting of medication(versus only 6 in 2000).
In Europe, the fight against the trafficking of drugs relies primarily on national systems which secure the distribution and marketing of drugs.
The situation is highly variable from one country to another.
Britain, for example, is among the European countries most affected by counterfeit drugs while France seems relatively spared.
The European countries benefiting from an efficient system of reimbursement of healthcare costs and highly regulated channels of distribution organized and supervised by health agencies are less exposed than others.
Yet, even in the better-protected countries such as France, the system of parallel imports (authorized by the European Community for dispatchers and wholesalers), the free movement of drugs and opportunities to purchase on the internet contribute to a weakening of the system and expose national markets to the increasing risk of fake medicine entry.
In Europe, only Great Britain, the Netherlands, and in a more supervised manner, Germany, have authorized the regulated sale of drugs on the internet. In Europe as elsewhere, the quantity of counterfeit medicines is increasing significantly.
-7. 423.824 in 2009,
-8.891.056 in 2008,
-2 711 410 in 2006,
-560.598 in 2005
-Netherlands (Dec 2004): the discovery of counterfeit medicines entered through parallel imports (see parallel imports)
-Spain (June 2005): seizure of 30 million fake tablets intended to be exported to Italy, France and Portugal
-Germany (Sept. 2005): dismantling of an Internet network proposing mandatory prescription drugs
-Belgium (Oct 2008): Customs officers at Brussels Airport seized 2.134 million tablets of counterfeit drugs from India, destined for Africa.
-Germany (June 2009): German customs seized false tablets of an unauthorized generic version of Viagra ® produced in India and destined for sale on the Internet.
As in the US and in contrast to developing countries, the market of counterfeit drugs essentially affects high value added products, “society” medicines and more regulated products (psychotropic drugs, anabolic steroids …).
Another issue is also worrying: the traffic of fake medicines is a financial bonanza for organized crime and terrorist networks.
Very cost-effective due to the low risks for traffickers, fake drug trafficking has become, in just a few years, the most lucrative of organized crime activities.
It is thus about to supplant narcotic drug trafficking at the top of the list of mafia activities (narcotics, prostitution, robberies, hold-ups...).
The money coming from this fraudulent underground economy irrigates the entire span of criminal and terrorist activities, directly threatening the security of goods and people around the world.
"Counterfeiting is a fully-fledged criminal activity, not peripheral to other criminal activities, but at the heart of them." (Secretary General of Interpol)
"Counterfeiting is a vehicle for organized crime and in its complexity and its gravity, it can only be compared to the trafficking of narcotics or weapons." Statement by the Council of Ministers of the European Union (November 13, 2003)
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Stop a global pandemic
The counterfeiting of medicines is not in itself a recent phenomenon. Yet, over the last decade, the scale of the traffic has reached a particularly worrying threshold: the proliferation of fake medicines now threatens the health of hundreds of thousands of patients across all five continents. Today, the falsification of drugs should be treated as a global health priority.Download PDF
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