Counterfeit medicine legislation ignores repackaging

Repackaging of medicines is still possible under the directive, despite the European Federation of Pharmaceutical Industries and Associations’s (EFPIA) claims that the best way to protect patients would be a ban on repackaging of medicines.

Repackaging of medicines is common practice in parallel trading, which refers to the buying and repackaging of medicines in cheaper markets for sale in higher priced markets.

Chief executive of Bayer HealthCare and president of EFPIA Arthur Higgins said that despite the lack of ban on repackaging it will continue to work with European institutions to “ensure that if there is repackaging of medicines, then patient safety will not be compromised”.

Instead the directive has proposed that it is made mandatory for certain categories of medicines sold in the EU to bear a “safety feature”, such as product codes and seals.

Details of which would be set in the member state’s implementing legislation.

According to the directive, it is essential that only a certified manufacturing authorisation holder can affix them.

The legislation is in line with a Financial Times report earlier in the month that claimed that the EU was likely to drop a proposed ban on repackaging medicines that would restrict parallel trading.

According to the report, EU trade and industry commissioner Günter Verheugen had “eliminated parts of the draft law designed to tackle counterfeit medicines, after protests from ‘parallel traders’ who arbitrage different prices between EU countries”.

EFPIA director general Brian Ager concluded: “Now the challenge is to make sure that the provisions proceed with no further delays and no dilutions to the measures proposed.”

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