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Counterfeit products harm patients and businesses

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Farzad Henareh, Stericycle ExpertSolutions, discusses ‘fake Europe’  and the impact of counterfeit pharmaceutical products

Counterfeit or knock-off drugs - whatever term we want to use, intellectual property violations in the pharmaceutical sector are growing and with every counterfeit product that reaches the market, the risk of harm, both to people and to businesses grows.  

In 2013 the World Health Organisation (WHO) launched a global surveillance and monitoring system to encourage Member States to report incidents relating to substandard, spurious, falsely labelled, falsified and counterfeit (SSFFC) medical products. The aim was to help develop a more accurate and validated assessment of the scope, scale and harm caused by this issue. As of January this year, over 920 medical products had been reported, representing all main therapeutic categories and representing both innovator and generic medicines.

Despite more effort being made to combat counterfeiting of products across the board, the acknowledged links to organised crime, and the harm it causes to brands and consumers, it is proving difficult to police and control, and the criminals behind it continue to make vast returns. In 2009, 20 million pills, bottles and sachets of counterfeit and illegal medicines were seized in a five-month operation coordinated by the International Criminal Police Organization (Interpol) across China and seven of its South-East Asian neighbours; this resulted in over 30 arrests and the closure of 100 retail outlets. In Europe in 2009 customs officials seized 34 million counterfeit pills in just two months.

Impact significant

While these figures are shocking, it is the impact on businesses and consumers in their everyday lives that has to be prioritised. This is not always easy because the criminals behind the counterfeit products have gone to great lengths to evade detection and to successfully introduce their products into the market.  The WHO warns that some fake medicines are almost visually identical to the genuine product. They recommend the following steps.

Affects genuine goods

While there are health and safety risks to consumers there are other issues for pharmaceutical manufacturers and retailers to deal with. Counterfeit products can reduce demand for genuine goods which lowers revenues, but in order to protect their brand reputation, companies often have to get involved in product recalls, investigations and legal action which is costly in terms of both time and money.   

Some well-known drug recall cases have hit the headlines in recent years. In 2007, for example, an emergency recall was issued by the Medicines and Healthcare products Regulatory Agency (MHRA). This related to drugs that included Casodex, the prostate cancer medicine; a drug for heart complaints called Plavix, and another, Zyprexa, used to control the symptoms of schizophrenia. In every case the drugs were counterfeit. The MHRA successfully seized 40,000 packs before they were distributed to pharmacies but 25,000 reached chemists across the UK and were dispensed to patients - a further 7,000 were recovered following a recall.

More recently in 2013, a recall was issued for pain relief and type 2 diabetes medicines. Whilst there was no risk to patients, the recall was a precautionary measure following concerns about the manufacturing process during an inspection of the manufacturing site in India. They included, poor record keeping relating to the manufacture and testing of the medicines made at the site and inadequate validation and production controls for medicines.

Fake condoms

Away from medicines, a case arose in Australia where fake Durex branded condoms, which may have had serious flaws in the latex, were recalled by the Australian Competition and Consumer Commission after they were sold at a discount on Groupon Australia. They had to inform consumers that they may be at risk of unwanted pregnancy or sexually transmitted disease from using the condoms.

Along with the electrical goods sector, pharmaceuticals suffers one of the biggest international counterfeiting problems and a number of different methods are being used to tackle the issue. One of these is serialisation. Regulations typically require the product number, batch number, serial number and expiry date to be included in the complete serialised number. This registered number is applied on the units to be scanned by retailers at the point of sale to verify authenticity. It cannot be scanned twice. Serialisation makes tracing and tracking recalled products much simpler. Numbers that correlate to an item’s serial number are also placed on the cartons, pallets and containers, which enables manufacturers to quickly locate products in the event of a recall.  A 3D barcode system is also being developed currently which would take advantage of the injection moulding by which many tablets are produced.

From the manufacturer’s viewpoint, if they are faced with a situation in which their products have been counterfeited, it might be advisable to consider a recall in order to take control of the situation. This will allow them to protect their brand and the safety of their valued customers, and to err on the side of caution when it comes to ensuring they comply with industry regulations. It’s worth bearing in mind too, that a good recall experience will enhance customer loyalty, particularly if they understand that the company is working with their best interests at heart.

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