The counterfeit drugs trade is thought to be the world’s largest fraud market, with billions of dollars making its way into the hands of organized crime gangs each year. 1
Around the world, the fake drugs market kills thousands of people each year and leaves many more paralyzed or suffering from severe health problems as a result of taking counterfeit products that may be contaminated or out of date. 2
Uniting in the fight against counterfeit drugs, Teva has rolled out a revolutionary new 2D barcode that could mean the end for these dangerous fake medicines. Spending in excess of $100m, Teva has created a new serialization technique to ensure authenticity of products and give greater peace of mind to both retailers and consumers, and keep illegal profits out of the hands of criminals.
The World Health Organization (WHO) estimates that revenues from counterfeit drugs are around $200bn, accounting for an estimated 10-15 per cent of the worldwide pharmaceutical trade. 3 They can be sold on the black market, over the internet, and in some instances fake medicines have even been handed over to patients in prescription medication.
As the use of these fake medicines rises globally, Teva has made its medicine even harder to fake by placing this 2D barcode, with a corresponding global track identification number, onto 326 packaging lines. Teva has been planning how best to implement the new barcodes with program manager Galit Meyran leading the serialization project since 2015.
Meyran believes that the barcode can give patients confidence in the products they are taking. “We are dealing with a small barcode that has a huge impact on our patient’s health and fulfils our brand promise. The consumer can confirm that they have an authentic product and that nobody is trying to sell them falsified medicine.”
The pharmaceutical industry has long placed an emphasis on traceability in the fight against counterfeiting, but this has not stopped criminals from producing and successfully selling counterfeit medicines. Counterfeiters have replicated all types of medicines from AIDS medication to anti-malarial tablets, with an estimated 1 in 10 medical products in low and middle-income countries being substandard or falsified, say the WHO. 4
Meyran, who worked with hundreds of employees at 38 Teva facilities worldwide to bring the project to fruition, added: “At Teva we don't stop at manufacturing the product and bringing it to market. We take every measure to ensure that patients and pharmacists can verify that the drug they are holding is an authentic Teva drug.”
In recent years, Teva has worked with governments and customs authorities around the world to try to stem the supply of counterfeit medicines. In 2013 Teva helped to unearth a sophisticated counterfeiting operation after a patient in Germany spotted spelling mistakes on a packet of medicine and contacted the firm. In response, Teva purchased some of this suspicious product to test in its own labs and discovered that although the drug contained genuine pharmaceutical ingredients it was not produced by them, as the product claimed.
To combat the increasing threat of counterfeit drugs and address the regulatory changes, Teva will change the packaging for billions of tablets and capsules produced each year to incorporate the new barcoding. Within Teva, this is the first time that a project has operated across such a wide array of departments, working with both global and local teams around the world.
Meyran, a former IT risk officer, who has been working at Teva for six years, added that the project is the result of years of collaboration between dozens of departments. “This project involved a truly global team, including artwork, procurement, supply chain, packaging and many global managers,” she said.
“This is a major global program for the company that will affect every area of our business. It’s a great achievement seeing so many different departments come together to share their knowledge.
“Like a philharmonic orchestra, all the different musicians have to work in coordination and perfect precision in order for the piece to be clear and sound good,” she added. “It has been challenging but I am proud of the team that has put this together.”
Historically, the use of counterfeit drugs has not been widespread in industrialized countries such as the US or western Europe, although with many consumers now using the internet to buy cheap medicine, examples of fake medicine have seen an uptick worldwide. The WHO estimates that in Africa, and in some parts of Asia and Latin America, the proportion of fake medicines can reach 20-30 per cent of the market. 5 Often the sale of counterfeit drugs adversely affects those living in the Third World, and sales of these medicines have also been discovered in the highly regulated markets of the US and EU.
To combat the immense damage caused by the use of counterfeit drugs the US Food and Drug Administration (FDA) introduced plans in 2014 to introduce regulations that will ensure that every sealable unit will be serialized by November 2018.The European Union (EU) followed suit and will introduce serialization by February 2019 while the Russian Federation also plans to implement similar regulation by January 2020.