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Counterfeit medicines have become an increasing problem in the UK as
counterfeiters and the networks that aid them seek to exploit what is
potentially a very lucrative market. Counterfeiters are also using ever
more sophisticated methods of producing fakes that are almost indistinguishable
not just to the public but to pharmacists as well.
The Medicines and Healthcare Products regulatory Agency has responded
to the threat of counterfeit medicines and medical devices with the publication
of “Anti-counterfeiting strategy 2007–2010”.
Speaking last week at the launch of the strategy at an MHRA conference
in London, health minister Dawn Primarolo said: “In line with global
trends, incidents of counterfeit medicines here in the UK, although rare
when compared to the size of the market, are on the increase.”
She went on: “Counterfeiters are engaging in this activity for
profits. They have learnt to target their efforts upon high-value, high-turnover,
high-demand products and focus on the most lucrative markets. Determined
counterfeiters will try to penetrate the regulated supply chain, which
can, on rare occasions, result in pharmacies unwittingly supplying patients
with counterfeit medicines.”
The MHRA response involves strategic and operational measures to minimise
the risk of counterfeit medicines and medical devices reaching patients
through both regulated and unregulated routes. The MHRA plans to:
• Provide reassurance to the public through providing balanced, accurate
and timely information, enabling informed choices to be made on how to
obtain safe medicines and medical devices
• Establish and maintain, in collaboration with industry and law enforcement,
a list of the medicines and devices most likely to be counterfeited and
to infiltrate the UK, and focus resources throughout the supply chain
against the products most at risk
• Encourage reporting and continue to investigate thoroughly all referrals
of suspected counterfeit medicines or devices
• Enhance and broaden the targeted market surveillance scheme
• Deliver and update constantly a strategic threat assessment of the
availability of counterfeit medicines and devices in the UK
• Fully participate with the World Health Organization, the European
Commission and other international bodies to combat counterfeit medicines
and devices
• Disrupt the market for counterfeit medicines and devices in the UK
• Increase the risk of prosecution to those involved in counterfeiting
medicines
• Identify the drivers behind these offences and influence changes in
domestic and international legislation to increase the risk for counterfeiters
and reduce their market
Michael Deats, group manager, MHRA enforcement and intelligence, said
that counterfeit medicines are most commonly available via the internet,
usually from sites hosted outside the UK. Accordingly, the MHRA strategy
takes a hard line on the internet threat — the MHRA is resourced
to investigate UK-based online pharmacies suspected of the criminal supply
of counterfeit products.
“Counterfeit medicines are less frequently, but perhaps more worryingly,
discovered in the regulated supply chain, that is through licensed wholesalers,
parallel traders and pharmacies. Incidents have steadily increased since
2004, with counterfeit medicine reaching patients on nine occasions,
necessitating batch recalls, and discovered at wholesale level on a further
five occasions,” he added.
Ms Primarolo summed up the problem: “Counterfeit medicines are
unarguably dangerous. They represent a threat to patients primarily through
a lack of efficacy, often containing the wrong or reduced amounts of
the active ingredients. They are invariably manufactured in filthy conditions,
transported and distributed inappropriately and can contain a number
of impurities.”
Ms Primarolo also said that the discovery of counterfeit medicines on
the market acts to undermine people’s confidence in the way they
obtain their medicines and dissuade them from taking medicines that may
be essential to treat illness.
The provision of easily accessible, timely and specific information is
key, the document suggests, setting out a strategy for providing such
information to the public and health professionals, as well as for media
coverage.
“It is vital to any anti-counterfeiting strategy that a balanced
message is communicated to the public. It is easy to alarm patients to
the extent
that they stop taking medicines that in the vast majority of cases are
perfectly safe, with the resulting detrimental effect upon their health,” it
states.
“A delicate balance has to be carefully reached in conveying
a clear message, in a manner that protects patients without causing undue
distress.”
A large part of the MHRA strategy involves “close and effective
collaboration” with public and private stakeholders both domestically
and abroad. The MHRA will forge closer links with the private sector
engaged in the manufacture, distribution and sale of medicines — the
document looks at manufacturers, wholesalers, parallel importers and
the generic medicines sectors, as well as postal services, providers
of security technologies and the medical devices industry.
The strategy also commits the MHRA to closer working with police, HM
Revenue and Customs and the Serious Organised Crime Agency to ensure
that the most recent information and intelligence is available.
A section of the strategy covers the work of the intelligence unit at
the MHRA. Each incident of counterfeits in the UK is analysed carefully
to understand how the perpetrators operate, and to identify the methods
of manufacture, mechanisms and preferred routes of distribution and any
weaknesses in current regulatory systems and legislation, the document
says.
“The success of this strategy will be largely determined through
the willingness of partners and stakeholders to recognise the threat and
to work together
now in reducing the risk to patients and, importantly, increasing the
risk to counterfeiters,” Ms Primarolo declared. |
The
Pharmaceutical Journal