EU sets out plans to make it easier to spot counterfeit medicines
Consultation has started on plans (PDF, 61K)to make it harder
for counterfeit medicines to circulate in the EU and to make it easier
to
spot them when
they
do.
Central to the proposals, which were published on 11 March by the European
Commission’s Directorate General for Enterprise and Industry, is
a plan to make European pharmaceutical law apply to everyone who trades
in medicines in the EU, whether or not they actually handle products
or even intend to place them on the European market. This would mean
that brokers, agents and traders who only use Europe as a staging post
in the distribution of medicines from one country to anotherwould be
subject to the same requirements as manufacturers and wholesalers.
In addition, manufacturers might be required to seal all packs of medicines
and to mark individual packs so that they can be identified and traced
at all stages in the supply chain, with records of all transactions other
than final supply to a patient being kept in a central record accessible
to everyone involved in the process. It would be illegal for anyone other
than the market authorisation holder and an end user (hospital, healthcare
professional or patient) to repackage or open any product.
It is unclear what impact the prohibition on opening packs would have
on parallel imports. The EC’s consultation paper notes that the
ban would make it impossible for package leaflets to be changed and says
that the consequences of this, and ways round it, will be addressed in
an impact assessment.
But the European Association of Euro-Pharmaceutical Companies sees no
problem. EAEPC secretary general Heinz Kobelt said: “DG Enterprise
confirms the principle, supported by the EAEPC, that repackaging should
only be carried out by market authorisation holders, which includes manufacturers
and licensed parallel importers.”
The EC consultation comes after a sharp increase in seizures of counterfeit
medicines at EU borders. In 2006, 2.75 million packs of counterfeit products
were seized, representing a 384 per cent increase over the previous year.
There have also been trends towards counterfeiting life-saving medicines,
as opposed to lifestyle medicines, and trying to get them into the licensed
distribution chain, rather than selling them over the internet.
|
The
Pharmaceutical Journal
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