A brand new and patented technology has recently been launched that protects patients from buying and using counterfeit medicines. Pharmaceutical companies can now effectively and very economically protect their products and supply chain with this technology, thus avoiding damages and incalculable liabilities resulting from falsified products.
The IT’S TRUE™ technology (www.its-true.com) has been passed by the German health authorities and is already in use by GALENpharma in Germany, protecting testosterone depot vials. This technique allows patients to effectively control whether or not the product they have obtained via a pharmacy or via the internet is genuine. By using a concealed code (simply scanned in via smartphone or typed in via internet or text message) and connecting to the IT’S TRUE database, they will know immediately whether or not the product is authentic. This technology can easily be applied to all existing pharmaceutical products on the market, as well as to common manufacturing and packaging lines, without additional regulatory efforts.
According to DIRECTIVE 2011/62/EU: “There is an alarming increase of medicinal products detected in the Union which are falsified in relation to their identity, history or source… Past experience shows that such falsified medicinal products do not reach patients only through illegal means, but via the legal supply chain as well. This poses a particular threat to human health and may lead to a lack of trust of the patient also in the legal supply chain.”
The WHO writes in its IMPACT anti-counterfeiting taskforce handbook: “We know that counterfeit medicines are a global public health menace causing death, disability and injury. They destroy the credibility of health systems and waste precious human and financial resources. They are found in all countries, both developed and developing.”
FDA Commissioner Margaret Hamburg, M.D., stated in her speech from October 8, 2010: “It is shocking to realize that, in some parts of the world, somewhere between 30 and 50 percent of drugs to treat serious diseases are actually counterfeit. And even still, it’s hard to really know the full extent of the problem.”
The direct economic damage for pharmaceutical companies caused by counterfeit drugs is enormous. The damage in lost image caused by counterfeit drugs with no active agents or with wrong dosages is incalculable. And pharmaceutical companies additionally face another enormous risk. They may even be made liable for the damage to health caused by such counterfeit products!
Wolfgang Kozianka, a Hamburg lawyer and member of the legal committee of the BAH (German Federal Association of Drugs Manufacturers), can only confirm this: “If it can be proven that a firm has not explored all available state-of-the-art avenues to prevent a counterfeit, and if damage arising from counterfeits brought into circulation by counterfeiters can then be proven, then the firm in question can be held liable in accordance with § 823 BGB (German Civil Code) and ProdHaftG (German product liability law). A duty of surveillance ultimately exists. The financial consequences of serial damage to the lives or health of consumers are incalculable and grave.” Thus pharmaceutical companies even have to fear class-action lawsuits being filed against them for damage caused by counterfeit medicines.
The IT’S TRUE™ technology was developed by IT’S TRUE™ - THE AUTHENTICATING COMPANY GMBH (Germany) over the past three years and has already received international patent protection (e.g. US 8,028,892). Founder Marcus Regensburger is delighted at the completion of this development: “I am glad that we have found renowned and potent investors and can now start to make this technique and service available to our partners in the pharmaceutical industry.”
The IT’S TRUE™ technology has been passed by the German health authorities and is already in use by GALENpharma GmbH, whose marketing manager, Jörg Mehnert, Ph.D., reports persistently positive experiences with this technology: “The authenticity of a pharmaceutical product can only be guaranteed when the complete chain, from the manufacturing site to the patient, is effectively controlled and can be ultimately checked by the patient. The IT’S TRUE™ Technology is, to my knowledge, the only technology worldwide which fulfils this comprehensive requirement. Furthermore, it is the most economical technology on the market.”