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In a laboratory on the outskirts of Tours, in the Loire region of France, a technician is examining a small cardboard medicine box under a microscope.
The equipment is more commonly used by fraud detectives to identify fake passports or counterfeit banknotes but on this occasion it is being deployed by French pharmaceutical company Sanofi to detect falsified medicine.
At the company’s Central Anti-Counterfeiting Laboratory, the suspect box is being compared with the real packaging of a common antibiotic, using high-tech imagery to look for anomalies in factors such as fonts, colours and engraving.
Falsifying medicines — making and selling products that have not been approved by regulators, fail to meet quality standards or deliberately misrepresent an ingredient — has become big business.
The World Health Organization estimates that revenues from counterfeiting of medicines are around $200bn, 10-15 per cent of the pharmaceutical market worldwide.
They are still rare in industrialised countries such as the US, Australia, Japan and much of Europe, representing fewer than 1 per cent of total market value. But in much of Africa and parts of Asia and Latin America, where retail channels are less tightly controlled and corruption can be rife, the proportion of fake medicines can reach 20-30 per cent of the market, says the WHO.
The organisation revealed this week that an estimated one in 10 medicines in poor countries were counterfeit and likely responsible for the deaths of tens of thousands of children from diseases such as malaria and pneumonia every year. It estimates that 100,000 to 1m people die each year as a result of fake medication.
Meanwhile the EU’s Intellectual Property Office says that €1.7bn in tax and social contributions are lost to the public authorities each year in Europe because of counterfeit medicines.
Improvements in technology and the way the internet has eased the development of fake pharmacies online have exacerbated the problem. While counterfeiting used to focus largely on solid forms, it is now affecting more injectable products that are used to treat cancers or diabetes.
“Drug counterfeiting is a public health emergency for the twenty-first century,” says Geoffroy Bessaud, director for anti-counterfeiting co-ordination at Sanofi.
In the past decade, various stakeholders have tried to step up the battle against falsified medicines and break down the criminal networks that distribute them. Large pharmaceutical companies such as Sanofi, Pfizer and Roche have created dedicated specialist laboratories to fight counterfeiting, by identifying and documenting instances of it, and improving the physical protection of medicines’ packaging to prevent tampering. Sanofi has more than tripled the number of specialists in its anti-counterfeiting laboratory, from five to 19, since it opened in 2008.
As well as meticulous visual examination of drugs and packaging, employees at the French company’s laboratory use handheld devices to conduct general chemical analysis to determine a medicine’s composition. They also scrutinise the product’s lot number and date of manufacture to see whether it can be traced back to a Sanofi site.
“In over 80 per cent of instances we can confirm if it’s counterfeit at this point,” says Nathalie Tallet, head of the laboratory, which has analysed more than 35,000 Sanofi products since it opened. “Then the final stage is further chemical analysis to establish whether the product contains the active ingredient or toxic compounds.”
Pharmaceutical companies are working with national and international authorities including the UN, the WHO, Interpol and customs officers to seize suspect medicines. There are special warehouses in their laboratories where they are allowed to hold counterfeit items under embargo for analysis.
This year 123 countries co-operated with an operation called Pangea X, which was aimed at combating illicit online pharmacies and led to the closure of 3,584 websites. More than 25m potentially dangerous fake and illegal medicines with an approximate value of $51m were seized.
Lawmakers are also starting to be more active. The Medicrime Convention, which was the first international legal instrument to criminalise all activities related to counterfeiting, production and distribution, came into force in January last year. European regulators are working on a serialisation project that gives every box a unique series number that can be matched by the pharmacist in a central database — an initiative that is set to be implemented in Europe by the end of 2018 or early 2019.
Then there is a push to increase awareness among the public and improve the training of healthcare professionals to make them more vigilant. “In developing countries the message is that drugs bought on the street will kill you,” says Professor Marc Gentilini, a longtime advocate for awareness against trafficking in falsified medicines. “In developed countries, the message is ‘don’t buy drugs on the internet’.”