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Pharmaceutical industry fights back against counterfeit medicines

Pharmaceutical companies are rolling out a variety of innovations to combat a rising tide of counterfeit medicines.

Delegates at the 9th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology in Lisbon, Portugal, yesterday (31 March 2014) heard about the scale of the crisis — and the measures being implemented to fight the fakes. “Pharma crime is growing, and it seems to be a huge problem,” said Guy Villax, chief executive of Horvione, a pharmaceutical manufacturer with headquarters in Loures, Portugal.

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Counterfeit medicines may contain the wrong levels of the active pharmaceutical ingredient (API), no API at all, or even the wrong API. According to the World Health Organization, roughly 10 per cent of the world’s medicines are counterfeit, a figure that rises to at least 30 per cent in many developing countries. Some 36 per cent of antimalarial drugs in south-east Asia are fakes, for example, seriously hampering efforts to stem the spread of the disease.

The rise of counterfeiting has been driven by increasingly globalised supply chains that are more vulnerable to fraudsters, a growth in drug purchasing over the internet, and lax regulatory regimes in many parts of the world, said Frédéric Bourgeois, associate vice president of global quality supply chain for Sanofi.

The global counterfeit medicines industry is now worth about $60bn per year, according to the WHO, and the profits for counterfeiters can be huge. For every US$1 invested, a heroin manufacturer might expect to make $20 — yet counterfeit versions of legal medicines command returns of $200 to $450, Dr Bourgeois said.

Proactive approach

Outlining how Sanofi and other pharmaceutical companies are tackling counterfeiting, Dr Bourgeois emphasised that they are now taking a much more proactive approach. Rather than simply waiting for customs agents or police to ask them to analyse suspect medicines, Sanofi now seeks out fakes in high-risk regions or online, and then tests them in its bespoke anticounterfeit laboratories in France.

Last year it checked about 4,000 products and found several hundred to be fakes, work that ultimately helped to close down 13 counterfeiting operations. “But we have to be humble,” Dr Bourgeois added. “This is the tip of the iceberg.”

Dr Bourgeois also underlined the importance of pharmacists in the pharmaceutical supply chain. In Africa, about 30 per cent of medicines are sold in the street, dramatically raising the chances that patients are buying fakes. “We cannot allow children in these countries to take bad products, sometimes poisons,” he said.

Sanofi and other manufacturers are adding a range of safety features to their products to reduce the risk of counterfeiting. Fake drugs are often loaded into authentic packaging, so it increasingly uses packets with tamper-evident seals. Security marking similar to those found on banknotes can also help to identify fraudulent products.

One of the most powerful anticounterfeit measures is to replace the barcodes on drug packaging with a “data matrix” — a black-and-white patterned square that can be scanned to read information such as the product’s batch number and expiry date.

These codes are already used in France, but Sanofi hopes that the matrix could soon carry a unique serial number that identifies every single packet of medicine. The manufacturer would place that serial number in a central database that can be accessed and verified at each stage of the supply chain.

Pharmacists would scan the matrix to check if the product came from a legitimate source — or even whether it has already been sold, offering a way to crack down on medical reimbursement fraud.

“It’s said that people trust their pharmacist more than their priest,” said Mr Villax. But, to maintain that trust, such measures are an essential part of preventing ineffective or even harmful fake medicines reaching consumers.

Legislation requires many of these anticounterfeit measures to be in place in all but a few EU countries by 2017, and the US plans similar developments over the coming decade. In Africa, where high-tech solutions are more difficult to implement, medicines can be labelled with a unique code hidden beneath a scratch-off covering. Consumers can text the code to a database that checks it and replies to confirm its authenticity. This technology is already being used in some parts of Africa on packets of Sanofi’s antimalarial medicine artesunate-amodiaquine.

As well as tougher anticounterfeit measures, Mr Villax also called for harsher penalties for counterfeiters. “At the moment, pharma crime pays — the sanctions are too light,” he said.

Citation: The Pharmaceutical JournalURI: 11136787

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