EU wholesalers express concern with pharma package

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Related tags: Member states, European union

The European Association of Pharmaceutical Full-line Wholesalers (GIRP) says it has concerns about the anti-counterfeiting proposals contained in the European Commission's recently-released 'pharmaceutical package.'

The GIRP welcomed the EC's proposal for new legislation aimed at preventing the entry of medicinal products which are "falsified in view of identity, history or source​" into the legal supply chain.

However, the wholesale group takes issue with what it describes as "the lack of initiative to properly tackle a number of important issues associated with the distribution chain.​"

Specifically, the GIRP is concerned about the number of licenses issued to distributors across the EU.

"Despite the widespread problem regarding the number of distribution licenses throughout the member states, ranging to over a 1,000 in some countries, no attempt is made to clean up or harmonise the conditions under which member states grant new licenses or control existing ones​," it claims.

It also takes issue with the fact that there are no provisions for mandatory inspections of “all license holders and all other actors in the supply chain.​"

One solution could be to include a ‘sunset clause’ applicable to all licenses, which would cause a license to expire "should it not be used over a defined time period.​"

The GIRP also believes the EC has missed an opportunity to establish a database of the existence or status of all wholesale players, other than Good Distribution Practices-compliant distributors and Good Manufacturing Practice-compliant manufacturers.

"The Commission acknowledges that, 'in order to ensure reliability in the distribution chain, pharmaceutical legislation should address actors in the distribution chain, but surprisingly neglects to address this point in their proposed amendments.​"

Instead, the EC's strategy of keeping counterfeit medicines out of the legitimate supply chains of member states rests on what the trade body dismisses as "a rather inconsequential national notification procedure.​"

The Commission acknowledges the distribution chain has become very complex, and is only as strong as its weakest link​,” said the GIRP.

“[But] it overlooks the day-to-day consequences of not making clear cut distinctions laying out defined responsibilities between the various players.​"

Regrettably, the Commission has invested a great deal of energy on issues which will yield little impact for addressing the ‘weakest link’. This means ‘other players’ will largely remain unaccountable,​” it concludes.

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