Background Information on Counterfeit Drugs
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- Medical Counterfeits
You can find answers to the following questions.
Counterfeiting medication is very profitable for criminals. They take advantage of the good reputation of products and brands that the original manufacturer established through its consistently high-quality products. Fraudsters are only interested in producing what looks like an exact copy, and do not care about the quality and effectiveness of the contents. In many countries, the risk of getting caught and punished for selling fake medicines is relatively low. So counterfeiting medication can be more lucrative than selling illegal drugs. However, the structures are comparable to those in organized crime.
Do you have questions? Here you will find answers as well as information on counterfeit medicines:
Anything that makes money will be counterfeited. This affects patented medications as well as generics. Expensive, prescription drugs, such as those used in AIDS or cancer therapy, are especially lucrative for dubious businesses. Antibiotics are the most commonly counterfeited drugs, particularly in low-income nations where medicines are prohibitively expensive for many people. In high-income countries, there is a growing trend toward fake “lifestyle” medications for treating erectile dysfunction. Theoretically, every patient is at risk, even though there might be differences at the national level. Patients should be cautious about buying drugs on the internet, or when purchasing medications abroad.
The World Health Organization (WHO) and the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) describe counterfeits as drugs that have been falsely labeled regarding their identity and/or origin to deliberately fool consumers. Basically, counterfeits are drugs that do not come from, or are not offered in the same form as, medicines from the original manufacturer. Exempted from this are changes that have been properly and lawfully made, as in the case of parallel imports. Counterfeits range from complete fakes that have been made by a counterfeiter, to original products with manipulated expiration dates. Examples of counterfeited drugs are medications that
contain the correct active agent, however, either at a dosage that is too high or too low,
have manipulated expiration dates,
possess no active agents,
contain an active agent other than the one specified, or
are wrapped in forged packaging, blisters and/or contain falsified patient information.
Unfortunately, patients, doctors or pharmacists may not be able to distinguish such “medications” from the real ones without a very detailed inspection. If consumers are suspicious, they should contact their doctor, pharmacist or the original manufacturer.
Authentic generics are credible medications. However, criminal organizations increasingly offer products that are supposedly equivalent to certain original generic products, or to their active ingredients. To prevent misunderstandings: “generics” are reputable medicines produced after the original (brand-name) product has lost its patent protection. Generics are available under a different name, yet offer equivalent quality to brand name products. Generics manufacturers can also be victims of counterfeiters. Here, too, the most important rule is: prescription medicines may not be distributed without a prescription. Any person or company who offers prescription medicines, and claims these are similar to an original product is possibly offering fake drugs. Please consult your physician, pharmacist or original manufacturer when confronted with dubious offers.
Medicines are used to treat diseases and to promote health. That is not important to counterfeiters. They are not interested in providing patients with a medicine that is equivalent to the original product. Even if a fake drug contains certain active ingredients, these medicines have a lower quality or quantity of the substance. This can cause a vaccination or test result to fail, for example, or can even lead to pathogens becoming resistant to the original active substance. Legislators have established an elaborate procedure to clinically examine, approve, and follow-up medicines for a reason.
In extreme cases, counterfeiters add dangerous or even toxic substances to their products to achieve the same “effect” (more precisely, a side effect, not a true medicinal property) as seen with the original medicine to simulate authenticity.
Ultimately, patients need reliable, easy-to- understand information about the indication, use and dosage of their medicines. This is why prescriptions are required – to protect patients from considerable dangers and potential damages of a drug. The prescribing physician and / or pharmacist explains the application, the correct dosage and possible side effects of the medicine to the patient. Anyone who provides prescription medication without a prescription bypasses this secure consultation for the patient.
Certain medical products may be sold only in pharmacies. Although these are not prescription medicines, only pharmaceutically-trained personnel may dispense them to consumers. Patients should not blindly trust internet offers for such products.
Illegal trade takes place around the world. The World Health Organization (WHO) estimates that counterfeit medicines worth 73 billion euros are traded annually. Dubious online pharmacies that conceal their true location deliver globally – reaching countries such as Germany, UK, Italy, Spain etc. or the USA. Supplies from illegal internet pharmacies – those without appropriate certification – are up to 50 percent counterfeits.
The extent of the problem varies greatly between regions and individual countries, and also depends largely on temporary supplies. The problem is highly dependent on how tight legal controls are. The WHO estimates that in some areas in Africa, Asia, and South America, more than 30 percent of medicines in circulation are fakes. In some countries of Eastern Europe, the proportion of fake medicines can be more than 20 percent. In Europe and in the USA, as well as in other developed countries, less than one percent of the medications sold are counterfeits.
Despite this, the trend shows that counterfeits in our globalized world are no longer just a problem of developing countries. When traveling, patients often purchase their medicines abroad (and in some cases, bring them home for family members and friends, even though it is prohibited to do so). Typical market structures and trading routes have been liberalized, allowing vendors to sell medicines at lower prices. And last but not least, the internet has made sales and trade of various articles simpler and more global.
International cooperation is needed, as counterfeits are a global problem that only can be solved through cross-border actions. Every country and every company must also take responsibility to protect consumers and patients. It is essential to relentlessly uncover fraud, and effectively prosecute counterfeiters. In the coming years, it will be important to establish national and international structures and networks, as well as create suitable legal guidelines. Furthermore, it is necessary to raise awareness in the relevant institutions and authorities, as is already largely the case with customs authorities.