The World Health Organization (WHO) suggests a broader and internationally accepted definition of “counterfeit medicine”:
“A counterfeit medicine is one which is deliberately and fraudulently mislabeled with respect to identity and/or source. This applies to the product, its packaging or any other information on the packaging or labeling. 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.”
Counterfeit drugs must thus be differentiated from:
- Defective drugs: produced legally but with manufacturing defects.
- Sub-standard drugs: while genuine and produced by authorized manufacturers, they do not fulfill the associated specifications and quality standards required by the registration specifications.
Generic drugs are authorized copies of brand name drugs whose patent has reverted to the public domain. Generics have the same qualitative and quantitative composition in terms of the active principle, the same pharmaceutical form and the same bioavailability as their brand name counterparts. They are regulated, monitored, and require authorization before entering the market. They therefore represent no difficulties in terms of public health. However, they too can be counterfeited!
These semantic difficulties have caused and still cause complications in terms of information about and the identification of falsified medicines, as well as posing legal problems. This confusion is exploited by counterfeiters who benefit from legislative loopholes to develop their traffic, risking little more than derisory sentences and inadequate law enforcement processes.
In order to put an end to these problems, the WHO now uses the term “falsified drugs” in all its releases and reports as well as terms such as “spuriously / falsely-labeled / falsified / counterfeit(SFFC) medicines. The ambiguous term “counterfeit” must no longer be used.
What is inside a falsified medication?
Analyses of falsified medication seized by customs or bought online reveal that they regularly contain five types of compounds that are harmful to humans:
Heavy metals (mercury, lead, arsenic, aluminum …) : According to a Korean study published in 2010, 26% of medicines bought from illegal online pharmacies contain products that are carcinogenic and toxic to the central nervous system, the kidneys, or the liver.
“Real poisons” (rat poison, boric acid, antifreeze…) : Toxic for the kidneys, they provoke renal insufficiencies and developmental abnormalities, they were the cause of death of 84 children in Nigeria in 2009 (the cough syrup identified contained in fact antifreeze).
Common household products (brick dust, paint, wood wax …) : Used by counterfeiters to improve the appearance of their falsified products, they are the cause of a wide range of undesirable effects from vomiting to vertigo and even death.
Incorrect and undesirable active ingredients (silbutramine, haloperidol …) : All put the patient at risk and can lead to health problems that are more or less sever depending on their dosage and effect (difficulty breathing, muscle spasms, hypertension, strokes…).
Complete absence of active ingredients : Not only do products with no active ingredients prevent patients from getting better but they divert effective therapies and prolong the wait before proper treatment can be administered, sometimes in urgent cases. These products can be as dangerous as falsified medicines with poisonous or substandard active ingredients and in certain cases they can be lethal.
Falsified medicines are a very real threat to patients’ health and must be battled relentlessly.
What types are concerned?
Economically developed countries tend to believe that only “social” or “comfort” drugs ared counterfeited. Reality is quite different. Far from being limited to a single category, counterfeiting extends to all types of drugs. The fact that they are considered vital or subject to mandatory prescription is of little importance to criminals, who only see a highly profitable business opportunity.
In 2012, the Pharmaceutical Security Institute (PSI) estimated that a total of 523 types of drugs have been counterfeited.
However, the types of drugs most counterfeited vary by global region and targeted populations.
In developing countries, traffickers target “vital” drugs and those of “first necessity”. Anti-malarials, antibiotics, TB, ARVs used in particular against the HIV (Human Immunodeficiency Virus), but also analgesics, anti-inflammatory medicines, and blood products are among the most widely falsified medical products, resulting in major risks to public health. The proliferation of falsified drugs has also resulted in patients developing a growing distrust of health systems, which slows their development in those countries that need it most.
In the United States, the situation is different. With a sharp contrast in prices with neighboring countries and considering the gaps in social coverage and the reimbursement of medical care, counterfeiting focuses mainly on products with high added value such as cancer medication and growth factor blockers.
The traffic of falsified “comfort” drugs has developed widely in wealthy countries in Europe as well as the United States, especially with the advent of online sales of medical products. Internet knows no borders and facilitates the traffic of all types of drugs internationally.
Doping products, products against sexual dysfunctions (such as Viagra), and weight loss products are frequently purchased online because they are not reimbursed, representing an ideal target for traffickers.
Countries with efficient reimbursement systems for medical expenses and regulated distribution channels, which are organized and supervised by health agencies are less exposed than others. However, with the Internet the quantity of counterfeit drugs is on the rise in Europe and elsewhere. “Comfort” drugs are no longer the only ones involved; all medical products are concerned!