Drug Safety

Danger to life and limb

Counterfeit medication is deliberately, and in a deceitful manner, wrongly labelled and in no way satisfies claims to quality, control, effectiveness, and safety. On the contrary: They endanger the health of those consumers who hope for effective drugs or even those who are really dependent on these. Despite our very good health care system, patients in Germany can also become victims of counterfeit medicine. Counterfeit drugs are primarily found in illegal online pharmacies, however, they also regularly make their way into the legal supply chains of pharmaceutical companies and wholesalers. The products of renowned drug manufacturers as well as those of generic manufacturers are in the forgers’ sights.

There are no limits – anything that can be sold will be faked: Counterfeits are not only so-called “over the counter” drugs that are available without prescription, but also prescription drugs against high blood pressure, diabetes, depression, or other illnesses. The fakes are not all the same: They range from preparations in counterfeit packaging to those which contain no active agents, the wrong combination of active agents, or the multiple amount of an active agent. The latter constitutes the lion’s share of counterfeits with 60 per cent. In the worst case this endangers not only the health of the patients, but also can lead to a consumer’s death. For criminals faking drugs is, however, a particularly lucrative business and has become a great deal more profitable than the trade with drugs or counterfeit cigarettes.

What does the Industry do?

Product piracy and smuggling can only be fought effectively across borders. Based on the highly dangerous situation for patients and the large market for counterfeit pharmaceutical products, the European Commission passed the “Falsified Medicines Directive” (2011/62/EU, known as FMD) in the year 2008. The aim of the anti-forgery protection directive and its delegated acts is the protection of patients from counterfeit drugs in the legal supply chain. Among other things,the directive includes compulsory safety features on medicine packaging, as well as a system for checking drug authenticity. In this way, it can be prevented that counterfeit drugs are channeled into the value and supply chain.

In the fight against the counterfeiting of their products, the demands placed on companies in the pharmaceutical industry are particularly high, due to their great responsibility towards the consumer. Besides technical measures, such as the serialization of products, detailed educational work, and abroad cooperation with the authorities are also part of patient protection. These and further possibilities are discussed within the IISW in order to increase the safety of consumers and products.