Call for zero tolerance on counterfeit medicines

Counterfeit medicines, already widespread in the developing world, are now being found increasingly in the EU, leading the European Federation of Pharmaceutical Industries and Associations (EFPIA) to call for zero tolerance.

"Even one single case of counterfeit medicine is unacceptable," said Brian Ager, director general of EFPIA. "Recent seizures of counterfeit medicines in the EU have shed light on the vulnerability of the pharmaceutical supply system and on practices that undermine efforts made by the industry to protect patients."

Recently, there has been alarming evidence that, besides the Internet, the licensed distribution chain, including authorised wholesalers, traders and pharmacies are being increasingly targeted by counterfeiters, as they allow distribution of high volumes of medicines.

The UK MHRA has reported that incidents affecting the regular distribution chain have increased steadily since 2004, with counterfeit medicine reaching patients on nine occasions, necessitating batch recalls, and discovered at wholesale level on a further five occasions.

Urgent measures are required to protect European patients, including a ban on medicine repackaging, EFPIA claims.

Under current EU rules, products can be re-boxed, re-labelled or over-stickered. Tablets can be removed from their blisters and reconditioned. These repackaging activities can involve removing the security seal and damaging unique identification codes that ensure product traceability. Such practices make it even harder to distinguish real medicines from fakes.

In its response to the public consultation launched in March by the European Commission, EFPIA stressed that the number one focus of the forthcoming EU legislative reform should be to ensure that the integrity of the original package is absolutely guaranteed throughout the entire supply chain, from the time it leaves the original manufacturer to the point that it reaches the end user. This is a prerequisite for an effective anti-counterfeiting strategy.

Liabilities should be more clearly defined for all involved in the distribution chain, including brokers, traders and agents. Heavy penalties should be enforced for trafficking in counterfeits. Penal sanctions should be all the more severe when counterfeiting threatens public health.

Efforts to set up a harmonised EU-wide identification system for medicines should be encouraged. EFPIA is making plans to launch a pilot scheme of a unique bar code system, which will enable the pharmacist to verify each medicine pack before dispensing it to the patient.