Manufacturers dodge EU wrath over counterfeits
that the EU needs to take to combat counterfeit drugs, yet track
and trace technologies were noticeably absent from their calls for
action.
In a non-binding resolution, members of the European Parliament (MEPs) have called on the EU to play a key role in promoting an international convention to create a specific criminal offence of counterfeiting or receiving and distributing counterfeit medicines in the legislation of every country.
MEPs are particularly concerned about the situation in developing countries where according to the World Health Organisation (WHO) 25 per cent of medicines are apparently counterfeit. In Pakistan and Nigeria, 50 per cent of drugs are fake.
With this in mind the legislators lamented the EU's involvement in the international fight against counterfeiting at a late stage when more open borders and the internet were likely to exacerbate the problem of piracy, without however pinning down responsibility to drug manufacturers as the logical starting point for product authentication and supply chain control efforts.
Not surprisingly therefore, the European Federation of Pharmaceutical Industries and Associations (EFPIA) "wholeheartedly" supported the resolution, welcoming the emphasis of MEPs on law enforcement and the responsibility of governments.
"There is no doubt that counterfeiting of medicinal products must be fought vigorously, primarily as it constitutes a threat to patient safety and public health," said Thomas Zimmer, chair of EFPIA's anti-counterfeiting working group.
"While counterfeit medicines have been so far rare in Europe, EFPIA stresses the importance of accessing medicines through certified distribution channels."
EFPIA believes the offence of counterfeiting should be subject to criminal sanctions throughout all stages of the counterfeiting process, from manufacture to sale.
This view is echoed in the resolution which calls for greater cooperation at both national and international level between the various authorities involved in anti-counterfeiting measures.
MEPs also asked the EU to take steps to strengthen the regulatory and quality control capacity for medicinal products and medical equipment put on the market in countries with inadequate resources and to improve access to affordable medicines.
Preventive measures in action programmes are needed according to the resolution, more specifically, the establishment of structures, cooperation, awareness campaigns, preferably carried out by the public authorities, and finally the political will to carry through such measures successfully.
No anti-counterfeit measures currently exist at an EU level specifically for medicines, but the European Medicines Agency (EMEA) works with the European Commission and national medicines agencies to tackle the issue.
Still the EMEA has not gone as far as its American counterpart, the US Food and Drug Administration (FDA), which has urged the drug industry to move towards electronic pedigree, such as radiofrequency identification (RFID) technology.
