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EU reviews counterfeit drug legislation

The EU Commission has said it will rule in 2008 over regulations to control the sale of counterfeit medicines, according to the Financial Times

The EU Commission has said it will rule in 2008 over regulations to control the sale of counterfeit medicines, according to a report in the Financial Times (FT) newspaper.

Gunther Verheugen, the EU industry commissioner, has commissioned studies to see if efforts to remove layers of bureaucracy and restrict the introduction of fresh regulations were superseded by the need to prevent counterfeit drugs and medical devices.

Jean-Francois Dehecq, the chairman of French pharmaceutical group, sanofi-aventis, has also supported a ban on the repackaging of medicines and tighter controls on parallel trade to exclude counterfeit drugs.

Big Pharma has accused parallel traders, which are generally small independent companies, of compromising supply chains safety between manufacturers and pharmacies, creating an opening for the sale of counterfeit drugs.

The European Association of Euro-Pharmaceutical Companies, which represents parallel traders, said that the European supply chain was "robust" and called the connection between the medicines it handles and counterfeit medicines "inaccurate".

The World Health Organisation has suggested that while counterfeit drugs are a problem for the developing world, they account for less than one per cent of medicines in developed countries. Most counterfeit drug movement in the EU are from internet sales rather than pharmacies.

The Association of the British Pharmaceutical Industry (ABPI) estimates that counterfeit drugs cost its members GBP 1bn (USD 2bn, EUR 1.5bn) in sales in FY05. The FT also mentions a 2004 London School of Economics study, which says that most of the savings were simply taken by the traders, without providing significant discounts to health services.

EU policymakers and institutions have remained largely supportive of parallel trade as a manifestation of the free movement of goods, but pharmaceutical firms attempt to stop parallel trade through legal channels and developing more complex packaging to distinguish their products from fakes. Another strategy is to restrict supplies in countries where drugs are sold more cheaply, which stifles surplus stock sold by parallel traders elsewhere.

23rd May 2007

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