PSM2012: The UK (MHRA) approach to combating Falsified Medicines

Heddell imageGerald W. Heddell,
Director of Inspection, Enforcement & Standards Division at the Medicines & Healthcare products Regulatory Agency in the UK, was introduced by Brian Finlay, Senior Associate and Director of Managing Accross Boundaries at The Stimson Center.

Heddell began his talk with a map of recent counterfeit incidents worldwide.  And then said, "Since I made this map last week, add Canada, India, South and Egypt and an additional 40 reports.
 This is the tip of the iceberg. Every country, in every continent, is
subject to the same threat of counterfeit medicines." 

Said Heddell, the vast majority of counterfeits discovered in the
UK are supplied over the internet. There have been 10 instances of
counterfeit medicines in the legitimate supply chain that reached
pharmacies and led to recall since 2004.  With over 850 million
prescriptions written annually, counterfeit medicines in the legitimate supply
chain are rare.  However obtaining medicines from unregulated sources
significantly exposes patients to the risk of receiving counterfeit

Consumers and patients deserve to have a high degree of confidence
when obtaining their medical products especially with a prescription from a
pharmacy.  Counterfeit medical products undermine that level of trust, and
lead to recalls, further damaging consumer confidence.  

The Council of Europe put together a Medicrime Convention to put
together a system to prosecute counterfeit medicine crimes, requires cooperation
and trains European police.

MHRA has developed a Falsified Medical Products Strategy that
seeks to reduce the risks to patients and consumers and to increase
the risk to those behind the illegal activity.  MHRA seeks to prevent
counterfeit drug crimes, by educating patients to the risks, and dissuade them
from purchasing from fake online pharmacies, to handle incidents efficiently,
and to investigate counterfeit sellers.

Heddell concluded that the given the porosity of the supply chain
a collaborative effort from all key stakeholders is the only way to
successfully tackle this issue.  Additionally, legal frameworks and/or a
national strategy can be very helpful to combat this issue and act as a
deterrent because protecting public health is the MHRA's overarching aim.

Heddell's slides are available here.