A study conducted by Future Market Insights reveals the global status quo in fighting pharmaceutical product piracy. According to this study, North America will also retain its leading role in fighting medical counterfeits over the coming decade.
Independently carried out investigations present alarming figures both on the health-related and financial damage caused by a growing number of counterfeit drugs. Copies range from cheap me-too preparations to expensive medications. Proving particularly popular are lifestyle products such as counterfeited potency enhancers, slimming agents and anabolic steroids from China, India or Thailand. The effects produced by illegally commercialised drugs are serious – first and foremost the danger they cause to patients, but also the economic damage caused to pharmaceuticals producers is substantial. According to current estimates of the European Union Intellectual Property Office, the Community budget suffers revenue losses amounting to over Euro 10 billion annually due to drug counterfeits.
Highest quality standards are indispensable in the pharmaceuticals industry. Latest technologies and skilled staff reduce errors to a minimum. Photo: Medipak Systems
Apart from the pharmaceutical industry above all the packaging sector is called upon to design packaging in such a way that counterfeits can be identified as fast as possible and effortlessly thereby preventing their circulation and/or simplifying drug recalls.
Companies already accepted this challenge years ago and introduced numerous packaging innovations aimed at increased patient safety. These include unique identifying features, authenticity seals – so-called Temper Evidence Labels - as well as safety devices protecting against manipulation as well as track & trace solutions for a gapless traceability of the individual products. They also include anti-counterfeiting features, be this holograms, synthetic DNA and laser codes or special printing inks invisible to the naked eye. For all of these different measures the study in North America predicts high annual growth rates of between 12.3% and 13.1% by 2026.
Track & Trace: CAGR of 13.1%
Concealed features: CAGR of 12.3%
Printing and graphics: CAGR of 12.8% (CAGR = Compound Annual Growth Rate)
Serialised packaging with tamper evidence. Photo: Bluhm Systeme GmbH
On the status quo in the EU
Stricter directives are expected to improve the situation for both the pharmaceutical industry and patients. This is why more and more governments around the globe are asking for safety features in drug packaging – making sometimes widely varying specifications. Multi-national pharmaceuticals companies therefore have to constantly cope with and react to new and suddenly altered requirements at short notice.
For companies the integration of the serialisation equipment into existing packaging lines as well as the assignment of data and specific technical training of the staff in charge constitutes a particular challenge. Alternatively, companies can opt for “offline serialisation” – that is at the folding box producer’s site. This saves them not only the integration of printing technology, camera and feed-out device into the packaging line but also the training of staff on how to handle this technology.
European Legislation The Delegated Regulation (EU) 2016/161 provides that all prescription drugs shall be provided with individual identification features and an anti-temper device. In concrete terms this means: from 9 February 2019 only packaging with individual identification features may be used for prescription drugs circulated in the European Union. Furthermore, the Regulation provides: