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EU's New "Pharmaceutical Package" Drops Repackaging Ban


To the delight of parallel traders – and consternation of anti-counterfeit groups – the EU Industry Commissioner has watered down the reform package's repackaging rules and, possibly, any benefits to be gained from the new serialization and other tracking requirements.

Losing ground in the areas of innovation, counterfeiting, and availability of medical information, the European Union has launched a four-part pharmaceutical reform package that includes proposals to tackle the growing issues of counterfeiting and illegal distribution of medicine.

In a press statement, European Commission Vice President Gnter Verheugen cited the goals of patient safety and the EU's desire to restore Europe as the "pharmacy to the world" as the driving force behind the package. Set to be transmitted to the European Parliament and the Council, the legislative proposals aim to:
  • Tackle the growing issues of counterfeiting and illegal distribution of medicines
  • Enable citizens to have access to high-quality information on prescription-only medicines
  • Improve patient protection by strengthening the EU system for the safety monitoring ('pharmacovigilance') of medicines

To address the risks of counterfeit pharmaceuticals entering the legal supply chain, the Commission proposes a number of changes to current policies, including these requirements to ensure packaging security:

  • Inclusion of obligatory safety features (such as a serialization number or a seal) on the packaging of prescription drugs
  • Verification of product authenticity by wholesale distributors, pharmacists or persons authorized or entitled to supply medical products to the public by assessing overt, covert or forensic devices, identifying individual packs, verifying whether the outer packaging has been tampered with
  • Prohibition against manipulating (i.e., removing, tampering with, or over-labeling) the packaging's safety features by intermediaries along the supply chain those in between the original manufacturer (typically the pharmacist) and the end user (doctor or patient)

While Europe's pharmaceutical industry almost universally applauded this development, many experts were disappointed when Verheugen facing heavy pressure from parallel traders and fellow commissioners revoked the ban. According to an article by Huw Jones for Reuters, parallel traders, those who buy and sell prescription drugs to exploit price differences among EU states, felt such a ban would have wiped them out since they have to repackage drugs so patients can read the explanatory leaflets in their own language. The commissioners feared the ban would have hampered the free movement of goods in the 27-country EU.

The revised directive now reads to the effect that any actor in the supply chain who packages medical products has to have a manufacturing authorization and only the holder of authorization can remove, replace or cover the safety features under strict conditions.

Many industry groups, including the European Federation of Pharmaceutical Industries and Associations (EFPIA), decried the move and insist that the best way to protect patients would have been a ban on repackaging of medicines something EU drug makers have been demanding. Other pharma experts like Dr. Adam J. Fein protested against this "loophole" in their blogs, saying, "Repackaging eliminates the benefit of just about every practical anti-counterfeit tracking technology, including the emerging serialization requirements in some EU countries. Apparently, tablets can even be removed from blister packs under EU law. Its hard to see how this will benefit consumers."

Exactly. While the pharmaceutical package's new anti-counterfeit directives are certainly welcome news, the watering down of the repackaging ban may also water down Europe's anti-counterfeit strategies.

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