The European Commission is expected to put forward a proposal later this month that will give the European Medicines Agency the power to require specific product identification in a bid to stop counterfeit drugs.

The news was announced at the 2008 TOPRA Annual Symposium and the proposal will be included in the Pharmaceutical Package Reform that is to be released by the Commission later this month.

The Commission believed the threat from counterfeit drugs was so dangerous that it was time to take action.

The Commission’s Stefan Fuhring said the challenge was two-fold by having to maintain the single market while responding to the global environment in which drugs are manufactured.

In May, at a High-Level Conference on Counterfeiting and Piracy, the Commission announced its intentions to upgrade legislation in the fight against counterfeiting.

Currently, within the EU, the Enforcement Directive (2004/48/EC) is the cornerstone piece of legislation but it only covers civil measures.

The Commission has adopted a proposal for a Directive and for a Framework Decision on intellectual property infringements. The proposal, which is currently pending in the Council, would require EU member states to treat all IP infringements on a commercial scale as a criminal offence.

The Commission is also proposing steps to improve the collection and quality of data, share best practices and increase public-private cooperation to improvement enforcement. In addition, inter-industry deals to crack down on the most evident forms of counterfeiting and piracy, including those on the Internet, could prove to be a very effective and efficient way to diminish the extent of the problems, it has been suggested.

Meanwhile, European Federation of Pharmaceutical Industries and Associations is demanding an EU ban on medicine repackaging, a harmonised identification system for medicines and heavy penalties that should be enforced for those caught trafficking in counterfeits. The association also wants better consumer education in regards to the risk of fake online pharmacies.

The Pharmaceutical Package Reform will contain other communications and legal proposals on the safety of the supply chain, information to patients and pharmacovigilance.

The reforms are aimed to address the new challenges, such as globalisation, that the industry and the European medicines Regulatory network face in the near future.