The European Federation of Pharmaceutical Industries and Associations (EFPIA) has called for a ban on the repackaging of medicines as part of a "zero tolerance" approach to the growing problem of counterfeit medicines in the region.
The World Health Organization (WHO) estimates that the value of fake pharmaceuticals will be $75bn by the end of the decade, equivalent to 10 per cent of the total worldwide market. In Europe, 2.7 million medicinal products were seized in 2006, up 384 per cent on the previous year, according to data published in March by the European Commission.
Under current European Union regulations drug products can be re-boxed, over-stickered and have their security seals removed. While such practices are a legitimate part of parallel importation, EFPIA maintains there is an impact on the traceability of pharmaceuticals.
Although it acknowledged that the vast majority of fake drugs are derived from internet sales, EFPIA believes that banning repackaging will help bolster the integrity of European supply chain.
Brian Ager, the group's director general said that "recent seizures of counterfeit medicines in the EU have shed light on the vulnerability of the pharmaceutical supply system and on practices that undermine efforts made by the industry to protect patients."
EAEPC "ban will have no impact"
In response, Dr Heinz Kobelt Secretary General of European parallel trade association the European Association of Euro-Pharmaceutical Companies (EAEPC) told in-PharmaTechnologist that he is "not astonished by the EFPIA's request for a ban on repackaging."
Kobelt went on to say that "a ban of repackaging will have no impact in combating drug counterfeiting," adding that "there is no evidence to suggest that repackaging by parallel importers has brought counterfeit products into the supply chain."
He concluded by saying that "the entry point for counterfeit products is elsewhere in the pharmaceutical supply chain because all parallel importers are required to obtain their supplies from licensed wholesalers. The real risks of counterfeits are outside the legitimate supply chain, in unregulated internet platforms."
Industry best placed to battle fakes
The debate follows a European Commission conference on counterfeiting and piracy held in Brussels earlier this week. The event was intended to provide a forum for the development of practical measures to address the wider problem of fake products sold in the region.
Speaking at the meeting, Charlie McCreevy the European Commission for internal market and services, said that the commission would work to establish bilateral agreements between member states, but added that "industry sectors themselves are best placed to lead the battle of the fakes."