Inside EDQM: Mass Serialization to Combat Counterfeit Drugs - Pharmaceutical Technology

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PharmTech Europe

Inside EDQM: Mass Serialization to Combat Counterfeit Drugs
Europe establishes new collaborative system to track products.


Pharmaceutical Technology
Volume 35, Issue 10, pp. 133-134

System benefits


Figure 1: The new European eTACT service model. EDQM is the European Directorate for the Quality of Medicines. (FIGURE COURTESY OF EDQM)
Allowing patients to verify the authenticity of their medication is a unique feature of EDQM's project that will significantly contribute to strengthening the public's confidence in the legal supply chain. Access for patients will be limited to verification and, given that their credentials will not be checked for privacy reasons, the level of information disclosed to them will be limited compared with that given to registered authorities and business stakeholders. (Figure 1 provides an overview of the eTACT service.)

For products and countries where the system will be used, UMI scanning will be mandatory for manufacturers supplying, and for pharmacies verifying, pharmaceutical products. As a result, a minimum amount of information is always available for verification (i.e., that the item exists, is genuine, and has been dispensed only once by a registered pharmacy).

Other business stakeholders in the supply chain between manufacturers and pharmacies may not be suitably equipped, or may not be willing to use the system systematically for cost reasons or because of high logistical constraints, such as speed of distribution (the efficient pharmaceutical distribution system is an asset to be preserved). For them, querying the UMI or capturing other transaction data (e.g., packing and shipping) will be optional.

This strategy makes the system proposed by the EDQM different from a pedigree or track-and-trace system, as is proposed in California, where any transfer of a pack from one party to another within the supply chain must be recorded, a step that represents a large business constraint.

The eTACT system will rely on a central EDQM repository, supported by decentralized repositories among the manufacturers or with national bodies in an information-sharing model. Existing national systems will remain in place.

The flexibility of this approach is a prerequisite for dealing with the key challenge of interoperability and for preparing for the complex implementation of future European requirements for the traceability of medicinal products, as defined by the recently adopted European Union Falsified Medicines Directive 2011/62 and its future delegated acts (2).

Conclusion

By providing business stakeholders and regulators with a flexible pan-European system, the EDQM eTACT project allows for a harmonized, standardized, and centralized securitization of the legitimate pharmaceutical supply chain, whatever the distribution route. The system extends to the legitimate Internet sales of medicines promoted in some European countries.

Public governance of such a system is vital to ensure effective and proper project development in coordination with regulatory authorities and to prevent the misuse of data (e.g., commercial data or information to patients on products).

Susanne Keitel is director of the European Directorate for the Quality of Medicines and Healthcare (EDQM) of the Council of Europe in Strasbourg, France. EDQM is responsible for the European Pharmacopoeia (Ph.Eur.),
.

References

1. Council of Europe, Medicrime Convention, 2010.

2. EU, Directive 2011/62/EU (European Parliament and Council, Strasbourg, June 2011).


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