EFPIA calls for ban on repackaging of medicinal products

The European pharma industry body EFPIA has called on the European Union to ban the repackaging of medicinal products as a measure to combat counterfeit trade.

Jean-Francois Dehecq, chairman of the board of Sanofi-Aventis and vice-chairman of EFPIA, said that the counterfeit trade is growing fast and has reached the "organised crime" stage. In 2007, 4,081 boxes of counterfeit drugs were seized at EU borders, a 51% increase on the previous year.

"What's new is the fact that counterfeit products have made their way into the traditional supply chain," said Dehecq. To deal with the problem, EFPIA has drawn up a global strategy but this will only work provided it is implemented in full, he stressed. In this context, it is necessary to "improve the efficiency of the investigations carried out by the international police forces" and to have adequate sanctions.

In most countries, sanctions for counterfeiting health products are generally no higher than for other types of "copying". Dehecq said he was pleased with the law that entered into force in autumn 2007 in France whereby risk to health now comes under the heading of aggravating circumstances in counterfeiting offences.

It is also necessary to reinforce control of the medicinal product distribution chain and this implies medicinal products should not be repackaged, as is frequently done by parallel importers.

But, Dehecq said, "When we talk of the need to stop people from playing around with tablets, boxes and blisterpacks, we are not opposing parallel imports, we are fighting counterfeiters." He added that banning repackaging was a prerequisite for stamping out counterfeit medicinal products.

However, the European Association of Euro Pharmaceutical Companies (EAEPC) stated that parallel imports provide the market with cheaper medicinal products that do not compromise patient safety.

"All parallel imported products are subject to a marketing authorisation that the importer/distributor must obtain either from the national regulator or, in the case of centrally approved medicines, the EMEA," it stressed. "Any repackaging or relabelling carried out by the importer is therefore performed at the behest of and under the supervision of the national regulator."

In view of the regulatory framework and the adherence of its members, the association objects to criticism it frequently receives. "Some in the industry allege that parallel trade leads to a lack of transparency in the supply chain, and to substandard or wrong packaging. Such allegations are completely unfounded.

"The debate surrounding public health and consumer protection should not be abused to advance industrial policy or commercial objectives."

The EAEPC is setting up a "warning platform" where members can exchange information on sources of doubtful products and that includes a supplier audit system. It has called for improved co-operation on the part of pharma companies and the authorities so that it can "become integrated in the ongoing initiatives" for making the pharmaceutical supply chain secure.

EFPIA has defined a new system for coding medicinal product boxes, called Data Matrix, that will ensure every box of medicines sold in Europe has its own identification number. The system will ensure "control throughout the supply chain" right down to the point of dispensing. The system will be tested in Europe, starting in 2009, most probably in Germany. If the trial proves successful, EFPIA will then extend it throughout Europe.

Dehecq said industry is ready to finance the new system, but, in return, it expects the European parliament to ban repackaging.