The European Alliance for Access to Safe Medicines
(EAASM) is a pan-European, not-for-profit patient safety organisation with the
vision that every European person will be aware of the dangers of counterfeit
medicines across the European community by 2015.
Its objectives are to:
- raise public awareness of all the dangers of
counterfeit and sub-standard medicines
- create a call to action for improved legislation,
enforcement and patient’s right for safe medicines
- input into existing anti-counterfeiting
initiatives where appropriate
- contribute to European health literacy.
In 2008, the EAASM undertook a covert operation
and ordered over 30 medicines from various websites. These were selected on the
basis of certain criteria, such as a functioning telephone helpline number and
a physical address suggesting real premises that could be traced. Of the pharmacy websites selected, not one asked for a prescription and 62% of the medicines the EAASM
received were fake or sub-standard. The
‘medicines’ arrived from locations as far afield as China, Fiji, Vanuatu and
India, in various wrappers including the sports pages of the Mumbai News!
To highlight the rapid increase of counterfeits
coming in to Europe, in 2007 the EAASM commissioned a report by Dr Jonathan
Harper (a prominent academic and commentator on supply chain security, who had
just recently completed a report for the Council of Europe). His 104 page, comprehensive document enabled
the EAASM to campaign for strengthened EU legislation, culminating in a new
Falsified Medicines Directive being passed. The EAASM was instrumental in ensuring
that this Directive was comprehensive, robust, practical and would enable the
tracking of medicines as they traveled through the often complicated,
international supply chain.
In essence, the Directive will mean that once the
law is enacted (which may not become obligatory until at least 2015), each
pharmaceutical pack will have to carry a unique identifying code that can be
authenticated at the point of dispensing. This, of course, has far-reaching implications
for all the pan-European supply chain systems as it will add complexity. But it
will also add a much greater degree of patient safety. In addition, the packs will have to contain a
tamper-evident safety feature. The issue of illegitimate online medicine-sellers
will also be addressed by the Directive, but education and raising awareness
remain the key to limiting risk in this context.
