Beware of Counterfeits

Background Information on Counterfeit Drugs

Counterfeiting medication is a very profitable business. Criminals simply take advantage of the good reputation of products which was established under great efforts by the original manufacturer. They are only interested in producing a perfect copy from the outside, and do not care about the proper contents. To save costs, they often produce counterfeits in their “backyard” without being obliged to fulfill the legal requirements for drugs. Pharmaceutical companies follow the legal requirements to ensure patients get a safe medicine. Additionally, in many countries, the risk of being effectively punished due to fake medicines is very low. Therefore, it is understandable that counterfeiting medication seems more lucrative than selling illegal drugs. However, there are also comparable structures of organized crime in the field of counterfeiting.

Here you will find answers to the following questions:

Who Is Affected by Counterfeit Drugs?  

Everything that is profitable will be forged. This can affect either medications protected by patents or so-called generics. Expensive, prescription drugs such as those used in AIDS or cancer therapy are especially lucrative for dubious businesses. Antibiotic treatments are the most commonly counterfeited drugs worldwide. Moreover, there is a growing trend in so-called “lifestyle” medications. At the top of the list stand drugs against erectile dysfunction. Therefore, theoretically, every patient is at risk, even though there might be differences at a national level. For example, patients should inform themselves before buying drugs on the internet or be especially cautious when purchasing medications abroad.

What Are Counterfeits? 

The World Health Organization (WHO) and the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) describe counterfeits as drugs which have been falsely labeled regarding their identity and/or origin to deliberately scam customers

To put things in a simple way, counterfeits basically are drugs offered to patients which do not come from or are not offered in this form by the original manufacturer. Exempted from this are cases in which changes have been done subsequently, as long as they have been performed properly and lawfully. Counterfeits range from complete fakes which have been made by a counterfeiter up to original products that have manipulated expiry dates to prolong shelf-life. Examples for counterfeited drugs are medications that

  • contain the correct agent, however, either at a too high or too low dosage,
  • have manipulated expiry dates,
  • possess no active agents,
  • contain another active agent than specified, or
  • are wrapped in forged packaging, blisters and/or contain fake patient information.

Such “medicines” are most often not distinguishable, neither by patients nor by doctors or pharmacists, without having more detailed information.

Beside Counterfeited Drugs, Are there also Substandard Products Available?   

It has been observed that criminal organizations continuously offer products that are supposedly equivalent to certain original products or their active ingredients. To prevent misunderstandings: There are reputable manufacturers which produce so-called “generics”, i.e. medicines that possess a similar quality to the original product and which are produced after the original has lost its patent protection. However, even these manufacturers can be targeted by counterfeiters. You should be very cautious if a dubious company tries to sell to you prescription medicines without the proper prescription and claim these are similar to an original product. Please consult your physician or pharmacist about the quality of dubious offers.

What Are the Risks for Your Health? 

Medicines are used to treat diseases and to become healthy again. It should be rather obvious that counterfeiters are not interested in providing patients with a medicine that is equivalent to the original product. Even if a fake drug contains active ingredients in some way, these medicines can cause a vaccination or test result to fail, or can even lead to pathogens becoming resistant to the original active substance. Legislators have therefore established an elaborate procedure to clinically examine, approve, and follow-up medicines for a reason.

In the end, poor information regarding indication and usage can be dangerous and cause harm even if the content is original. In extreme cases, counterfeiters add dangerous substances to their products to achieve the same “effect” (to be more precise it is a side-effect and not a true medicinal property) as seen with the original medicine.

The Problem on a Global Scale  

The World Health Organization (WHO) estimates that in Europe and in the USA, as well as other developed countries, less than one percent of the medications sold are counterfeits. However, in developing countries the issue is on a completely different level: According to experts, up to ten percent of the medicines available there are counterfeited. The problem is highly dependent on how tight legal controls are. In some countries of Eastern Europe, the proportion of fake medicines can be more than 20 percent, and in some areas in Africa, Asia, and South America even 30 percent. These numbers, however, are not representative of the entire area. The issue of counterfeited drugs varies between regions of a country and can depend on temporary supplies. However, dubious online pharmacies which conceal their true origin, deliver up to 50 percent counterfeits into the entire world – and thus also reach countries such as Germany or the USA.

Currently, there is no reliable estimate whether and in which way these cases merely represent “the tip of the iceberg”. The trend shows that counterfeits in our globalized world are no longer just a problem of developing countries.

When travelling, patients often purchase their medicines abroad (and in some cases, even bring them home for family members and friends, even though it is prohibited to do so) without considering they might have accidentally bought a counterfeit. 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 globalized the way we sell and buy products.

Organizations, Associations, Authorities  

Counterfeits are a global problem that only can be solved beyond borders. At the same time, every country and every company needs to take responsibility protecting consumers and patients.

It is important to consequently uncover, and effectively prosecute counterfeiters. Throughout the next years, it will be important to establish national and international structures and networks, as well as create suitable legal guidelines, especially with regard to high penalties. Furthermore, it is necessary to raise awareness in the affected institutions and authorities, as well as among those purchasing such counterfeited medicines. Lastly, we have to consider whether new and liberal political guidelines regarding production and selling of medicines actually facilitate counterfeiting.

Last updated: March 27, 2017 Copyright © Bayer AG
https://www.bayer.com