Healthy Skepticism Library item: 12832

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Publication type: news

Does parallel trade make Europe safer?
PM Live 2008 Feb 14
http://www.pmlive.com/index.cfm?showArticle=1&ArticleID=6479

Full text:

This was the question posed (and answered in the positive) by Heinz Kobelt, secretary general of Europe’s parallel trade association (EAEPC), yesterday as he moved to convince delegates at SMi’s 2nd Annual Parallel Trade Conference that the authorities should give traders more room to manoeuvre.

“We have a different commercial model, but we share the same safety concerns as the [innovative pharma] industry,” he said during a presentation which sought to clarify how the practice of parallel trade (PT) can serve to enhance the protection of Europe’s patients from counterfeit products, as well as manufacturer errors.

“We are serious when we talk about safety in our supply system,” he said, highlighting several instances where EAEPC members had discovered and alerted others to the presence of counterfeit medicines in the regulated supply chain, as occurred last year when fake Zyprexa was spotted in the UK. He also cited cases where parallel traders had found and eliminated potentially dangerous products whose defects were due to “manufacturer errors” – such as a batch of 40mg Nexium pills enclosed in damaged 20mg blister packs, and missing log numbers and expiry dates from Lipitor packs – from the supply chain.

Some in the room, including Jim Thomson of the European Alliance for Access to Safe Medicines (EAASM), expressed empathy and even support for PT’s challenge in dealing with a regulatory system which dictates how medicines should be repackaged and relabelled, yet forbids traders to attach any ‘safety seals’ of the kind removed during box opening.

The Association was also praised for its fresh endeavours to develop a supply system based on a set of standards put together by the QPs (Qualified Persons) of leading importers, as the “next step” to improve the security of Europe’s supply chain.

Debatable motives

However, a bullish Thomson was also keen to put the record straight over recent ‘mud-slinging’ by the EAEPC with reference to a report written by academic and analyst Dr Jonathan Harper (and published by the EAASM in November 2007), in which the ‘value’ of PT was challenged – and the hazards spotlighted – in no small measure.

The report focused heavily on the iniquities and vulnerabilities PT purportedly brings to the European pharmaceutical distribution system, a position supported openly in recent weeks by Günter Verheugen, vice-president of the European Commission, responsible for enterprise and industry (click here for full story).

In response to the Harper report, the EAEPC is understood to have threatened the EAASM with legal action, branding the report’s contents as “black propaganda”. At the SMI meeting yesterday, Thomson sought to restore a clearer perspective between the author’s findings and the aims of the EAASM, which he said is not an anti-PT organisation per se but simply a pro-patient safety group.

He criticised the EAEPC for “going into media overdrive” in its reaction, reiterating that the author was writing as an independent academic rather than a direct representative of the EAASM. However, he also concurred openly with several of Harper’s conclusions about the links between PT and counterfeit medicines entering regulated markets in Europe, as well as the perceived risks to patient safety imparted through re-boxing and re-labelling.

As for the argument that PT makes medicines safer in Europe, Thomson concluded, it is “illogical and a high-risk bluff”. He noted that there was no mention of ‘patient safety’ anywhere in the EAEPC’s mission statement, whereas it is the EAASM’s – and Dr Harper’s – primary concern.

Kobelt admitted that the EAEPC member which inadvertently introduced counterfeit pharmaceuticals to the UK market last year was “not careful enough in its sourcing” and had “fallen into a trap”. He reassured delegates that the association is taking measures to enhance its role in supply chain security, and that the president of the EAEPC (and head of the British Association of European Pharmaceutical Distributors), Richard Freudenberg, is keen to discuss the options with all other stakeholders, including industry and generics associations as well as the EAASM.