[Ip-health] PharmaTimes- EU anti-counterfeiting proposals "cannot ignore" internet

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EU anti-counterfeiting proposals "cannot ignore" internet
05 October 2009
The European Commission's proposed directive to clamp down on
counterfeit medicines "cannot ignore" the reality that a "huge
percentage" of counterfeits are channelled through the internet, says
the new rapporteur for the proposal in Parliament's Committee on the
Environment, Public Health and Food Safety (ENVI).

Maria Matias was speaking at a meeting in Parliament on Making Patient
Safety a Priority, organised by Aegate, the UK-based company that
supplies a pharmacy-level authentication system to sift out counterfeit
drugs from the legitimate supply chain.

While the proposed directive released in December 2008 addressed key
points of vulnerability in the legal supply chain, the Commission left
internet trade to the discretion of the member states, placing it in the
wider context of whether national governments allowed sales of
prescription medicines online. The issue had already been raised by
Adamos Adamou, the previous ENVI rapporteur before the European
parliamentary elections last June.

Introducing the meeting, MEP Jorgo Chatzimarkakis pointed to a study by
the German Federal Criminal Police Office (Bundeskriminalamt), which
found that 80% of counterfeit medicines penetrated the EU supply chain
through the internet.

The Commission's proposal should urge the member states to enforce
domestic law on internet sales, Chatzimarkakis told the meeting. And
countries that permitted internet pharmacies should establish a list of
secure websites for the trade.

Legal basis
Other major "gaps" in the proposal highlighted by Matias included
broadening its legal basis from the internal market provisions in
Article 95 of the EC Treaty to Article 152 on human health protection.

The internal market rules were widely reckoned to have underpinned the
Commission's decision not to pursue a ban on repackaging of medicines as
an entry point for counterfeits. A ban is still sought by the European
Federation of Pharmaceutical Industries and Associations (EFPIA) and is
strongly resisted by the parallel import industry.

The new rapporteur mentioned parallel trade and repackaging as complex
issues that needed to be addressed in the proposed directive. The
question was whether or not the provisions for mandatory safety features
should entail a ban on repackaging - although this was "work in
progress".

Defining the types of safety features required, and whether they should
be risk-based, was another high priority, Matias emphasised. John
Ricketts, associate director of government affairs for Lilly Europe,
argued for a "compulsory minimum standard" of safety feature, comprising
mass serialisation and tamper-evident pack seals. Further security
measures would be necessary for those medicines deemed particularly at
risk.

John Chave, secretary general of the Pharmaceutical Group of the
European Union (PGEU), warned against undermining the precautionary
approach demanded by the growing threat of counterfeits. "There's a
danger that if you single out certain medicines as risky, you merely
push on the counterfeiters to other kinds of medicines," he said.

A risk-based system might also confuse patients: "Do we create a sort of
implied guarantee or warrantee that medicines that don't have safety
features are thereby safe and free from counterfeiting?"

But Hugo Carradhina, senior manager, health economics affairs for the
European Generic Medicines Association, insisted the fight against
counterfeiting should focus mainly on behavioural measures such as
harmonising criminal law and toughening up requirements for wholesale
licences.

Technical solutions should be considered only as a secondary line of
defence, and then according to risk assessment based on past incidence
and price. Given the low level of counterfeits in the legal supply chain
and the ease with which safety features could be replicated, any
mandatory features must be proportionate, Carradhina stressed -
otherwise, "what we're trying to do here is basically kill a mouse with
a tank".

While EFPIA is set to launch the pilot phase of its coding and
identification solution - mass serialisation using a 2D data matrix
barcode and pharmacy-level authentication - in Stockholm on 20 October,
Aegate already has its end-to-end system up and running in four European
markets.

Although there are clear parallels with the EFPIA system, one point of
contention is what happens to the transactional data picked up in the
authentication process. Aegate takes the view - as does PGEU - that
these data belong to pharmacists. There are worries that, with an
industry-led system, the data will be exploited commercially to secure
marketing advantage.

A presentation by Professor Steven Simoens of Belgium's Katholieke
Universiteit Leuven testified to both the robustness of the
AegateProtect service and its favourable cost-benefit profile. For
example, a mystery shopper audit in a sample of Belgian community
pharmacies using the system found it was 100% reliable, Professor
Simoens reported.

Moreover, a cost-benefit analysis in a hypothetical market where five
pharmacy software providers covered 10,000 pharmacies dispensing 400
million drug packs a year concluded that the authentication system would
be cost-neutral in a scenario where just 0.47% of products were
identified as recalled, expired or suspicious.

By Peter Mansell



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