EGA Press Release

Tuesday, 02 December 2008

COUNTERFEIT MEDICINES
A PUBLIC HEALTH ISSUE NEEDING FOCUSED SOLUTIONS

“Misunderstandings and confusion surrounding the meaning of the term ‘counterfeit’ is diverting focus from tackling the real problem of fake and potentially dangerous medicines reaching patients”, says Greg Perry, Director General of EGA. Speaking on the eve of the 3rd general meeting of the WHO IMPACT (International Medical Products Anti-Counterfeiting Taskforce) in Tunisia, Mr Perry also urged the EU Commission to ensure that its own proposal for EU legislation focuses on the real problem of high risk counterfeiting of expensive branded originator medicines and internet sales.

IMPACT
Under the IMPACT definition, “a medical product is counterfeit when there is a false representation in relation to its identity[1], history or source[2]. This applies to the product, its container or the other packaging and labelling information. Counterfeiting can apply to both branded and generic products. Counterfeits may include products with correct ingredients/components[3], with wrong ingredients/components, without active ingredients, with incorrect amounts of active ingredients, or with fake packaging. Quality defects or non-compliance with Good Manufacturing Practices/Good Distribution Practices (GMP/GDP) in legitimate, authorised medical products should not be confused with counterfeiting.”

“This is a workable and practical definition”, Perry says. “It is important that enforcement agencies are not burdened with proving intent each time they need to make a seizure. However, 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.”

“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, but with growing confusion in other areas such as ACTA and SECURE where patents and patent infringement is being mixed up with counterfeiting and piracy. A recent example of such confusion in the EU led to Switzerland being identified as major source of counterfeits.”

European Union
Unlike in developing countries, the counterfeiting of medicines remains relative small-scale in the EU “at less than 1%”[4]. Current barriers to counterfeit medicines in the EU are proof of the highly effective regulatory system. Measures employed include reporting systems between medicines agencies, good customs controls and, very significantly, the reimbursement of prescription medicines which serves as an added financial deterrent to counterfeiters. These barriers are often missing in developing countries.

Moreover, in the EU there have to date been no reported cases of counterfeit generic medicines. “We must keep it that way”, Perry says, “and maintain our goal of zero tolerance.” The competitive prices of generic medicines in the EU — where top products sell at between €0.04 to €1.40 a pack — do not make generic medicines a very attractive target for counterfeiters, ensuring their low risk. However, counterfeit versions of popular and expensive branded originator medicines are leaking into the system and the new EU provision should deal firmly with this threat, firstly by tightening up the licensee system, secondly by regulating internet sales, and thirdly, by implementing special track and trace systems for high risk originator products where appropriate.

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1. For example, any misleading statement with respect to name, composition, strength, or other elements.
2. For example, any misleading statement with respect to manufacturer, country of manufacturing, country of origin, marketing authorisation holder.
3. This refers to ingredients or any other component of a medical product.
4. Source: WHO Fact Sheet 275

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