Counterfeiting seizures “exceeded our worst fears”

The EU industry commissioner has said the scale of pharmaceutical counterfeiting “exceeded our worst fears” and the EPHA has weighed into the debate on the development of the draft directive.

Speaking to German newspaper Die Welt Gunter Verheugen, European commissioner for enterprise and industry, revealed that in two months 34m counterfeit tablets were seized in the European Union (EU).

Verheugen added that the European Commission (EC) is “extremely worried” by the “constantly growing” number of counterfeits. The commissioner’s comments come at a time when the final contents of the draft directive tackling counterfeits are under debate ahead of a vote next year.

European Public Health Alliance (EPHA) is the latest organisation to have its say on the matter. The organisation, which receives financial support from the EC, supports the majority of measures in the draft directive but has expressed concerns about some areas.

In particular EPHA believes a clear definition of falsified medicines needs to be included in the directive. This view is shared by the Committee on Industry, Research and Energy (ITRE), one of three parliamentary groups proposing amendments to the draft directive.

EPHA and ITRE could still see a clear definition of falsified medicines inserted into the directive before it is put to a vote, which Chris Oldenhof, president of the Active Pharmaceutical Ingredients Committee (APIC), believes will take place in April or May 2010.

Before this date ITRE and the Committee on Internal Market and Consumer Protection (IMCO) will offer opinions on the directive to the Committee on Environment, Public Health and Food Safety (ENVI).

ENVI is the leading Committee for the directive and has the option to accept or reject the proposed amendments. If ENVI rejects the amendments the other committees can appeal.

Once this process is complete the directive will go to the European Parliament for approval and then the Council of Ministers must agree on the text.