[e-drug] EU clamps down on reimportation

["Kirsten Myhr" <kirsten.myhr@relis.ulleval.no>]

E-drug: EU clamps down on reimportation
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[Copied as fair use]
http://bmj.com/cgi/content/full/325/7372/1058

BMJ 2002;325:1058 ( 9 November )
EU clamps down on reimportation of cheap drugs meant for Africa
Rory Watson, Brussels

The European Union is taking measures to prevent low cost drugs intended for
patients in some of the world's poorest countries from being diverted and
resold for huge profits in the West.

By clamping down on the illegal trade in reimported drugs that undercuts
standard European prices, the EU is hoping to encourage pharmaceutical
companies to expand the trend of making medicines available at special rates
to the developing world.

The initiative comes amid growing evidence that cut price drugs are being
diverted onto the European market. Recent investigations by Belgian customs
authorities uncovered large quantities of GlaxoSmithKline products notably
Combivir (zidovudine) Epivir (lamivudine), and Trizivir (abacavir)destined
for Africa being sold in the European Union (12 October, p 794).

Under the scheme, which covers both patented and generic products, companies
will register with the European Commission the drugs they intend to sell at
lower, tiered prices. These would then be stamped with a highly visible
special logo - light blue capital E surrounded by 15 gold stars to alert
customs that they should be banned from re-entering the union.

To qualify for the register, the commission has, for the first time,
proposed a definition of low cost, tiered pricing. The drugs must be sold at
either the cost of production plus 10% or at a price reflecting 80% off the
average "ex factory" price in member states in the Organisation for Economic
Cooperation and Development.

Initially, the scheme will only cover medicines for the prevention, the
diagnosis, and the treatment of HIV/AIDS, tuberculosis, and malaria and will
apply to 49 least developed and 23 other low income countries, mainly in
Africa and Asia.

Announcing the plan, Pascal Lamy, the EU trade commissioner, said: "The EU
wants to set an example with a practical means of helping poorer countries
struggling with public health crises. Vaccines and contraceptives have long
been available at affordable prices now developed countries need to make an
effort with other medicines."

He added that the initiative was a concrete example of the trade
liberalisation commitment made during last year's negotiations in Doha,
Qatar, and was just one element of a broader poverty reduction and health
programme for the developing world.

The commission is confident that the governments in EU states will approve
the plan before the end of the year, and it is hoping that other major
pharmaceutical producing countries, notably the United States, will follow
its example. However, it also acknowledges that to a large extent the
success of the scheme will depend on the vigilance of customs authorities.

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Kirsten Myhr, MScPharm, MPH
Head, RELIS Ost Drug Information Centre
Ulleval University Hospital
0407 OSLO, Norway
Tel: +47 23 01 64 11  Fax: +47 23 01 64 10
kirsten.myhr@relis.ulleval.no
www.relis.no
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