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UK regulator launches new counterfeit medicine strategy

Gerald Heddell - MHRAThe UK Medicines and Healthcare products Regulatory Agency (MHRA) unveiled a new anti-counterfeiting strategy this week as it reflects on a successful five-year campaign against the trade in falsified drugs and medical devices.

The new document - available to download here - is the second published by the MHRA and comes on the back of what the agency's director of inspection, enforcement and standards Gerald Heddell (pictured) describes as "a marked reduction in known incidents of falsified medical products which have penetrated the regulated UK supply chain."

The decrease in activity is attributed to the UK becoming less profitable for counterfeiters compared to its European neighbours because of exchange rate factors, increased regulatory vigilance and aggressive public education programmes, as well as some high-profile prosecutions of counterfeiters.

In fact, since the notorious case in 2007 in which thousands of packs of counterfeit cancer and central nervous system drugs reached the hands of patients in the UK, there have been only a handful of incidents.

One batch of falsified asthma drugs was recalled in 2009, while in 2008 and 2011 there were isolated cases of authentic arthritis and HIV products in counterfeit packaging reaching the UK market, although these were intercepted at the wholesale level.

All told, there have been 10 known cases in which falsified medicines reach the pharmacy and patient level since 2004, and the MHRA says it has seized a total of £25m ($40m) worth of counterfeit and stolen medicines in the last five years.

Nimo Ahmed, MHRA acting Head of Enforcement said: "The UK market for medicines is immense and is estimated to be worth around £8bn."

Combating the real and present threat posed by counterfeit medicines and medical devices "continues to remain a priority for the MHRA," he added, noting that the agency is committed to working closely with international partners and providing leadership in dealing with this issue."

One aim of the revised strategy is to take into account the measures adopted in the EU Falsified Medicines Directive (FMD), which will become applicable in the UK on January 2, 2013.

While the first document emphasised communication of the problem, collaboration with stakeholders and regulatory approaches to reduce the threat, the new strategy zeroes in on three main topics: prevention, incident handling and investigation.

Prevention will rely on communication of the threat, market surveillance and testing, vigilance at UK ports, pharmacovigilance and information-sharing with other groups, according to the MHRA. Measures to date have included the creation of a Watch List of high-risk products, a nationwide testing scheme and representation of the MHRA in national and international anti-counterfeiting groups.

The new incident management strategy aims to ensure reports of suspect medicines are investigated swiftly and efficiently, with the main focus on minimising public exposure to the material, for example by recalling affected medicines. Policies are laid out for analysis and assessment of the incident, gauging the risk to the public, communicating that risk, and gathering evidence for prosecutions.

On the topic of investigations, the MHRA says its priority is to follow-up and prosecute all possible cases, with an emphasis on tracing the falsified product back through the supply chain to its source, and also following the money trail for payments.

Just last week the MHRA succeeded in securing a £14.4m confiscation against Martin Hickman, who was sentenced to two years imprisonment in June 2009 following his conviction on six counts of selling and supplying fake and unlicensed medicines and money laundering.




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