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Zero tolerance for counterfeit medicines
Counterfeit medicines, already widespread in the developing world, are now being found increasingly in the EU. While Internet-based sales are the main source of counterfeit medicines, these products are also appearing in the traditional supply chain. Urgent measures are required to protect European patients, including a ban on medicine repackaging.
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Position Papers:
- EFPIA Position Paper on Commission's Proposal on Counterfeit Medicinal Products (October 2009)
The European Commission is proposing a number of legislative actions to address the problem of the increase of medicinal products detected in the EU which are falsified in relation to their identity, history or source. While broadly speaking EFPIA welcomes the Commission's initiative to propose concrete measures to address these problems, EFPIA does not believe that patient safety would be fully secured through the Commission’s current proposals.
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Counterfeits have been found to contain toxic substances. Others contain no active ingredient, or the wrong amount of it - damaging to any medical treatment, but dangerous when patients are being treated for serious illness. In most cases, it is impossible for the non-expert eye to distinguish the fakes from the originals.
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Contributions:
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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, which ensure product traceability. Such practices make it even harder to distinguish real medicines from fakes.
In addition to the development of security features on medicine packaging, individual companies are assisting authorities in different ways, for example by training officials to recognize fakes and by assisting with international police investigations. However, these initiatives alone are not enough.
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Contributions:
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EFPIA is convinced that an effective and payable technical concept for anticounterfeiting needs three integrated elements: a tamper evident container closure system, overt and/or covert authentication features such as machine-readable inks and optically variable devices; a randomized barcoding with 2 dimensional barcodes on itemized packaging level and a transparent supply chain.
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The EFPIA White Paper is intended to express the views of the European drug manufacturers, associated within the EFPIA to combat counterfeiting effectively as it is described in the EFPIA Position Paper of June 2005 in order to: address the needs to further develop the European legislation; focus on key European stakeholders in the international collaboration; define the role of suppliers, drug manufacturers, wholesalers, distributors and pharmacies in the combat against counterfeit medicines; focus on effective and affordable solutions of supply chain control to achieve transparency and recommend rules and messages for communication to the various stakeholders
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The focus of the forthcoming EU legislative reform (Pharmaceutical Package) 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.
In addition, 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. Efforts to set up a harmonized EU-wide identification system for medicines should be encouraged.
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