When I first published my paper on parallel trade of medicines in 2003 (http://www.cne.org/publications2.htm) there were no reported links between this phenomenon and counterfeit drugs in Europe. Today, it seems that this connection is increasingly established, unfortunately.
As pointed out here (http://www.pharmatimes.com/WorldNews/article.aspx?id=12674) the other day, the European Commission is gearing up to legislate on this after the summer. Commissioner Verheugen said before Parliament that packaging and labelling, and indeed product recalls pose a "considerable risk" to patient safety.
How’s that ? Parallel traders, admittedly a legal and legitimate business in the EU, have the right and are often obliged to interfere with the original manufacturer’s packaging (except for the blister packs) by re-boxing and re-labelling the goods, before re-exporting them. Patient leaflets need to be replaced when sending products intended for the Greek market to the UK, for instance. Parallel importers are in principle legally obliged to submit the modified packaging to the original supplier ; in practice, this is hard to enforce and therefore rarely occurs. And here’s the rub : as the supply chain is broken and packages are modified, there is opportunity to introduce both counterfeit, substandard or useless products.
Ultimately, parallel distribution hinges on the paradox by which EU member states set prices but goods are simultaneously free to circulate within the Union : Verheugen announced that solutions will be presented, but until further notice, pricing is not part of the EU’s remit. And free pricing will not be part of the member states' political agenda in the short or medium term; and only this would in effect resolve the issue, but it entails wholesale health care reform to get the government out of the sector.
As pointed out here (http://www.pharmatimes.com/WorldNews/article.aspx?id=12674) the other day, the European Commission is gearing up to legislate on this after the summer. Commissioner Verheugen said before Parliament that packaging and labelling, and indeed product recalls pose a "considerable risk" to patient safety.
How’s that ? Parallel traders, admittedly a legal and legitimate business in the EU, have the right and are often obliged to interfere with the original manufacturer’s packaging (except for the blister packs) by re-boxing and re-labelling the goods, before re-exporting them. Patient leaflets need to be replaced when sending products intended for the Greek market to the UK, for instance. Parallel importers are in principle legally obliged to submit the modified packaging to the original supplier ; in practice, this is hard to enforce and therefore rarely occurs. And here’s the rub : as the supply chain is broken and packages are modified, there is opportunity to introduce both counterfeit, substandard or useless products.
Ultimately, parallel distribution hinges on the paradox by which EU member states set prices but goods are simultaneously free to circulate within the Union : Verheugen announced that solutions will be presented, but until further notice, pricing is not part of the EU’s remit. And free pricing will not be part of the member states' political agenda in the short or medium term; and only this would in effect resolve the issue, but it entails wholesale health care reform to get the government out of the sector.
