Who amongst us, on a business trip to Hong Kong or Mexico, has not at some time been offered some attractive, shiny product at a ridiculously low price? Nine times out of ten you ignore it, you know it’s fake, but you might be tempted to buy that “genuine” silk scarf for your loving wife, or an ingenious new toy for your child. You know that most of this merchandise is fake, but today’s forgers are becoming ever more adept at producing accurate copies of branded products and the online buying habit has multiplied the opportunities to exploit the human desire for a “bargain”.
The broad definition of counterfeit is a fake or unauthorised copy of a genuine product, typically medicines, designer clothes, sports goods, toys, electronics and other high-value goods – imitations of genuine items, pretending to be authentic. Counterfeit products often use inferior materials in food, drinks, medicines, and personal care products which may contain useless or harmful ingredients, some of which may be dangerous or even fatal. According to the Organisation for Economic Co-operation and Development (OECD), the quantity of counterfeit and pirated goods in global trade has grown substantially and by 2019, made up approximately 2.5 percent of global trade, valued at an estimated US$464 billion. In the European Union (EU) alone, imports of counterfeit and pirated products reached an all -time high of €3.43 billion, involving 152 items seized, up to 5.8 percent of total imports. This does not include the unknown number of items that were not caught by customs.
Pharmaceuticals – The health risk
Up to two billion people around the world have little or no access to basic necessary medicines, vaccines, medical devices and other health products, which creates an easy market for substandard and fake products. The risk to life from using these fake products is the main medical concern, but the loss of reputation of genuine manufacturers damages their ability to invest in new drugs and vaccines. The pharma industry continues to use new methods of protecting and labelling medicines which cannot be copied, but criminal gangs pour resources into perfecting their highly lucrative fakes. The European Union (EU) has a strong legal framework for the licensing, manufacturing and distribution of medicines, centred around the directive on falsified medicines for human use, so that only licensed pharmacies and approved retailers are allowed to offer medicines for sale, including legitimate sale via the internet. The European Medicines Agency is working closely with its partners on the implementation of these laws. A rough estimate – the global value of total counterfeiting and piracy was estimated to be US$2.8 trillion in 2022, a major slice of this pie was pharma, inflated by the demands of the Covid pandemic.
A review in Forensic Science International entitled ‘trends in counterfeit drugs and pharmaceuticals before and during the Covid-19 pandemic (2022)’ reported that antibiotics, painkillers, and “lifestyle expensive pharmaceuticals like hormones, steroids, anorectics, erectile dysfunction drugs and psychotropic drugs” were among the most targeted by counterfeiters. During the Covid-19 pandemic, commonly counterfeited products included antiviral medications, antimalarial chloroquine, and vitamins. Doctors from low- and middle-income countries report a worrying rise in deaths caused by antibiotic-resistant infections.
It is believed that the rise in the availability of fake medicines is a significant factor in mortality, despite seizures of millions of counterfeit drugs by international Customs. the World Health Organization (WHO) says some US$200bn worth of falsified or fake medicines are being sold every year – especially with the cost of legitimate medicines often beyond the reach of those on low incomes. As cheap fakes can be acquired via the internet, the spread of these medications is also gaining ground in high income countries.
The who uses labels such as substandard, falsely labelled, falsified, and counterfeit to characterise medicines that are forged to appear authentic. Both generic and innovator medicines can be falsified, ranging from expensive products for oncology to inexpensive items such as analgesics. These drugs may cause considerable harm to patients, but fail to treat the diseases for which they were intended. Some fake medicines have been found to contain mercury, arsenic, rat poison, or even cement.
There were 6,615 pharmaceutical crime incidents in 2022, an increase of 10 percent compared to 2021. All regions covered experienced an increase in incidents in 2022, which included 1,738 incidents in Asia-Pacific, 934 in Latin America, and 185 in Africa. Direct region-to-region comparisons can be complicated due to competing law enforcement priorities, lack of funding, or inadequate regulatory structures in certain regions of the world. As a result, counterfeit drugs can often go unnoticed.
The WHO estimates that the share of counterfeit and poor-quality drugs on the market ranges from over 10 percent of total sales in low-income and middle-income countries to 1 percent in developed countries. Demand for weight loss drugs such as Ozempic is leading to a wave of lifestyle medicine counterfeiting not seen since the Viagra phenomenon.
United Nations Office on Drugs and Crime (UNODC) in 2023, claimed that counterfeit medicines in sub-Saharan Africa could be responsible for nearly 500,000 deaths per year. The increase in counterfeit goods sales, driven by the rise of globalised supply chains and e-commerce, is enabled through the use of de minimis shipments or small packages not requiring Customs controls. in 2023, 92 percent of counterfeit seizures by the U.S Customs, involved small packages. This loophole may soon be closed by President Trump’s new trade rules.
Fighting back
The pharma manufacturers have introduced anti-counterfeiting technologies to product packaging to allow inspectors to verify authenticity. The European Union Intellectual Property Office (EUIPO) Observatory on Infringements of Intellectual Property Rights has developed an anti-counterfeiting technology guide to address the lack of information on technology solutions available on the market and help companies improve their protection against counterfeiting. In this guide, the main anti-counterfeiting technologies currently on the market are described and classified.
The European Medicines Agency has a strong legal framework for the licensing, manufacturing and distribution of medicines. This directive, introduced in 2011, aims to prevent falsified medicines entering the legal supply chain and reaching patients. It introduces harmonised safety and stronger control measures across Europe by applying new measures At the end of the distribution chain, only licensed pharmacies and approved retailers are allowed to offer medicines for sale, including the legitimate sale via the internet.
Air cargo’s role
Much of the responsibility for detecting and dealing with the flow of fake goods falls on Customs officers who provide the main defence against all fake goods that get into the supply chain. Forwarders and handlers working with known and reliable shippers are able to prevent most of the counterfeit goods getting past them, but devices such as anti-tampering seals, screening and overall awareness from skilled and well trained staff help. Collecting data and cooperating with customs and security officers can prevent criminals from getting access to airfreight, but the use of de minimis parcels has allowed a unknown quantity of drugs such as Fentanyl has provided a convenient entry into the airfreight supply chain. The drastic new restrictions imposed by the USA will most close the loophole. In the main, knowing and trusting clients and other stakeholders is the best defence. Forwarders and handlers employ specifically trained inspectors to check and to double-check exactly what it is they’re moving. Emerging technologies will certainly help in future detection, but the criminals have access to the same resources. You cannot beat good old human knowledge about who you are dealing with.
