Articles from April 2010

Council of Europe’s Medicrime convention underway

In further attempts to protect the public health from counterfeit medicines, more than 140 senior officials from health, law enforcement and judicial authorities from around the world came together mid-April to discuss Medicrime – an international convention covering topics of the manufacture, supply and trafficking of counterfeits – with the aim to make counterfeiting of both medicines and their individual components a criminal act.

Henk de Jong, who sits of the Council of Europe committee, said on the topic «The current situation is that counterfeiting of medicines is handled differently across all the countries in Europe and the penalties levied are often not a sufficient deterrent…The CoE convention is trying to lay down sanctions that are proportionate to the potential harm caused to patients.»

The convention has enormous reach, out to not only the 47 member countries of the CoE, but also to non-CoE countries around the world, added Prof. De Jong.

The convention opens discussions around preventive measures including the introduction of quality and safety requirements for medical products, and measures ensuring their safe distribution, whilst also establishing a framework for international cooperation on criminal law.

The Committee of Ministers of the CoE will be invited to adopt the Convention on 12 May. It will then be opened for signature and ratification by member states at the Conference of Ministers of Justice in Istanbul, Turkey, on 25-26 November.

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EFPIA releases anti-counterfeit verification pilot project results

EFPIA’s product verification system pilot project of which involved the scanning and verification of almost 100,000 medicine packs, successfully demonstrated that a product verification system at the point of dispense, based on a two-dimensional data matrix, is both robust and effective.

The product verification system could provide a valuable asset in reducing the risk of counterfeit medicines reaching patients via the legitimate supply chain.

Key findings from the pilot include that the system provides for the effective identification of fake packs as well as expired or short dated packs and recalled products. There was a clear need for packs to have only a single barcode; users were sometimes confused by the presence of more than one code on the pack. The results strongly indicate that the proposed EFPIA model is viable, proportionate, secure and cost-effective.

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Importation of illegal drugs decreases in Denmark

Due in-part to a wide-ranging educational campaign, the Danish Medicines Agency believes the practice of purchasing medicines illegally over the Internet is declining.

Kim Helleberg Madsen, head of the department at the Danish Medicines Agency, is encouraged by the trend shown in Denmark but still has concerns about repeat offenders of importation. 234 people were caught a second time importing illegal medicines in 2009, despite the risks of fines that double for each subsequent offence. «I’m not sure these people can be deterred by fines and by being told that they’re breaking the law,» he said.
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Drug validation tool for customs pioneered

Janssen-Cilag, subsidiary of Johnson&Johnson, has developed a new browser-based portal, accessible via a secure Internet site, which has been set up in close collaboration with customs officials to will make it easier for customs to check whether a suspect pharmaceutical shipment is fake or genuine.

«Customs want to check products for authenticity reliably, but are often
hampered by lack of complete documentation from the rights holder and
having to use a manual approach to detecting counterfeits,» said Karl Boonen, executive director of healthcare solutions and business support at Janssen-Cilag.

The DVP portal overcomes that obstacle by making sure that all product
packaging and shipping labels are available in a three-dimensional, 360-
degree visualisation, accessible via a simple, visual interface, which is
kept up-to-date by the rights holder.

Prior to full amterialisation of the tool, the DVP system has been presented to the European
Federation of Pharmaceutical Industries & Associations (EFPIA) as well
as the Pharmaceutical Security Institute (PSI)

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