UK regulator launches new counterfeit medicine strategy
Phil Taylor, 04-May-2012
The 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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