Healthy Skepticism Library item: 14535

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Publication type: news

Taylor L.
Did industry critics or parallel trade row halt EU pharma package?
PharmaTimes 2008 Oct 29
http://www.pharmatimes.com/WorldNews/article.aspx?id=14631&src=EWorldNews

Full text:

Industry critics claim that a lobbying campaign against European Commission proposals to ease the current curbs on industry communication with consumers led to the postponement last week of the proposed European Union (EU) package of pharmaceutical legislation, but other sources says it was due to a rethink by legislators of stringent proposals concerning parallel trade, including a ban on repackaging.

Patient advocacy group the Picker Institute and consumer organisation Which? have claimed that groups who believe that the draft directive on patient information “could have undermined the EU-wide ban on the advertising of prescription medicines” had raised sufficient questions for it to be impossible to achieve the consensus required before the law could go on to the European Parliament and the Council of Ministers.

Angela Coulter, chief executive of the Picker Institute, pointed out that no groundwork has yet been done in Brussels on the separation of objective, non-promotional information from advertising. There is no consensus on this at the policy or legal levels, and in practice the distinction could be unworkable, she added.

Meantime, a ban on repackaging was first mooted in a Commission public consultation earlier this year, after Guenter Verheugen, the Commissioner for Enterprise and Industry, told Parliament that the initial findings of a study into drug distribution had shown that parallel imports pose a “considerable” risk for patient safety for “numerous” reasons. The consultation pointed to the potential dangers for patients when packs are opened for repackaging and changed for relabeling purposes and proposed that repackaging should be banned.

Moreover, earlier this month a report conducted for the Commission by independent consultancy Europe Economics called for new legislation to outlaw repackaging and relabeling and concluded that parallel trade presents no benefits to patient safety, only disadvantages.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) welcomed the report, and pointed out that making repackaging illegal was not about a ban on parallel trade. However, the European Association of Euro-Pharmaceutical Companies (EAEPC), which represents the parallel importers, said in a statement to Pharma Times that the report was “short on robust and empirical evidence to support its conclusions” and was “categorically not a reliable base for good policy-making.”

Then, just ahead of the publication of the legislative package, which was scheduled for October 21, the Commission let it be known that it did not intend to ban repackaging or indeed make any changes to the regulations covering parallel imports. The proposals put forward by Commissioner Verheugen were considered by Brussels to be too punitive on the parallel traders who are, as spokesmen pointed out, conducting a legal activity, and the Commission does not intend to change this, they said.

While no new date has been given for publication of a revamped legislative package, the anticounterfeiting proposals will not include proposals to ban either repackaging or relabeling, said the spokesmen.

However, cracking down on the trade in counterfeits is still a priority for Commissioner Verheugen, and on October 22 he told Parliament that the Commission will draw up new regulations to ensure a medicine is traceable throughout its entire lifespan, right from the source of its active ingredients. “The technical solutions required to ensure traceability of medicines already exist,” he said.