Protecting EU Patients Against Counterfeit Medicines EFPIA Welcomes The Commission's Commitment To Take Action

Main Category: Pharmacy / Pharmacist
Also Included In: Pharma Industry / Biotech Industry
Article Date: 24 Mar 2008 - 15:00 PDT

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EFPIA, the European Pharmaceutical Industry Association, welcomes the European Commission's initiative to launch a public consultation in preparation of a legal proposal to combat counterfeit medicines for human use.

Counterfeiting of medicinal products has become an increasing threat for patients in Europe. EFPIA has called for a range of measures to ensure that the highest quality products reach the patient; a ban on repackaging of pharmaceutical products; clearly defined liabilities for all involved in the distribution chain (including brokers, traders and agents); stricter auditing rules and controls of the supply chain and applying penalties for trafficking in counterfeits.

In addition, investments in anti-counterfeiting technologies are being made by the pharmaceutical industry to enhance product security. EFPIA is also making plans to launch a pilot project in the area of mass serialization (2D barcoding system) towards the end of 2008.

The data and analysis outlined by the Commission corroborates the evidence collected by EFPIA on prevalence of counterfeits, including the increasing penetration in the EU legitimate supply chain. As long as repackaging and breaking of seals in the distribution chain is allowed, patient safety will be highly at risk.

While Europe is part of a global network of routes for counterfeit medicines in transit, the complexity and fractured nature of the distribution system in the EU and regulatory loopholes and shortcomings in the enforcement of Community legislation offer an opportunistic means for illegal operators to access Europe's legitimate supply chain.

EFPIA insists that there should be 'zero tolerance' for counterfeit medicines and calls for the application of the precautionary principle to protect patient safety1. Counterfeits pose a number of serious public health risks2: the counterfeit may not contain the correct active ingredient or the right amount of active ingredient; quality standards may not have been respected; the medicine may have an incorrect dose; foreign or toxic bodies may be present in the medicines, etc.

In addition to the direct risk of harm to patients, consideration should be given to the harm and costs that counterfeit drugs involve caregivers, health system resources and the health delivery system at large.

EFPIA believes that decisive and urgent action is required to enhance product security in order to protect European patients and will submit a detailed response to the Commission's public consultation by the 9 May deadline.

References

1 EFPIA documented seven cases of counterfeit medicines entering the EU legitimate supply chain, all having been detected in the UK. Each case involves thousands of boxes, i.e. thousands of potentially injured patients.

2 For a full overview of counterfeit risks EFPIA suggests a reference to the WHO's guidance.

European Pharmaceutical Industry Association