Misunderstandings and confusion about the actual meaning of the term ‘counterfeit’ is diverting focus from tackling the real problem of fake and potentially dangerous medicines.
That is the view of Greg Perry, director general of the European Generic medicines Association (EGA) who was speaking ahead of the WHO International Medical Products Anti-Counterfeiting Taskforce (IMPACT) meeting in Tunisia. He went to note that under the IMPACT definition, “a medical product is counterfeit when there is a false representation in relation to its identity, history or source”.
This applies to the product, its container or the other packaging and labelling information, Mr Perry added, and counterfeits may include correct, wrong or even no active ingredients or fake packaging. However he stressed that the IMPACT definition states that “quality defects or non-compliance with Good Manufacturing and Distribution Practices in legitimate, authorised medical products should not be confused with counterfeiting”.
Mr Perry argued that “this is a workable and practical definition” and it is important that “enforcement agencies are not burdened with proving intent each time they need to make a seizure”. Moreover, he added, it is important that the IMPACT definition “does not include alleged patent infringement products which have nothing to do with counterfeiting or public health risk.”
He went on to claim that “the problem in the definition does not lie with IMPACT, which is doing an excellent job in dealing with the real problem of fake products being pushed by criminals”. Rather the issue of most concern is “growing confusion in other areas” such as ACTA (the Anti-Counterfeiting Trade Agreement proposed by the USA and Europe among others) and the World Customs Organisation’s draft SECURE treaty, “where patents and patent infringement is being mixed up with counterfeiting and piracy”, Mr Perry said. A recent example of this confusion in the EU led to Switzerland being identified as major source of counterfeits, he noted.
No counterfeit generics in EU yet
Mr Perry added that unlike in developing countries, the counterfeiting of medicines remains relative small-scale in the EU “at less than 1%” and current barriers to counterfeit drugs in the union “are proof of the highly effective regulatory system”. Moreover, in the EU there have to date been no reported cases of counterfeit generic medicines and Mr Perry said “we must keep it that way and maintain our goal of zero tolerance”.
He concluded by noting that the competitive prices of generics in the EU – where top products sell at between 0.04-1.40 euros a pack – do not make them a very attractive target for counterfeiters, ensuring their low risk. However, fake versions of popular and expensive branded medicines “are leaking into the system and the new EU provision should deal firmly with this threat”.
This should be done by firstly tightening up the licensee system, regulating internet sales, and thirdly, “by implementing special track and trace systems”, Mr Perry ended.
