Serialization Position Paper from EFPIA IFPMA and PhRMA

Extracts from the position paper.Download the full Position Paper here.

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The global R&D based pharmaceutical industry is committed to ensure patient safety and is actively engaged in helping to secure the legal supply chain, namely through serialization, worldwide. With many different systems currently in the pipeline, our goal is to promote serialization based on international standards in order to favor harmonization and reduce any disruption to medicine supply and availability.

A considerable amount of counterfeit medicines reach the patient through illicit online pharmacies; however, the threat of falsified medicines penetrating the legal supply chain (even in industrialized countries with effective regulatory systems) is also very real.

The EFPIA IFPMA and PhRMA Position

  • No single solution will prevent counterfeiting. Rather, a holistic approach comprising use of covert and overt anti-counterfeiting features, a well-regulated, secure supply chain and appropriate laws and penalties to deter and punish counterfeiters, is necessary to provide maximum patient protection.
  • Within this framework, the R&D based biopharmaceutical industry supports product serialization and verification as one tool to help stop counterfeits penetrating the legitimate supply chain and to help to ensure that patients receive the right medicine.
  • Given the significant resources and investments in capital equipment and software systems necessary to facilitate product serialization and verification, it is critical that systems be implemented in a step-wise, scalable manner, to realistic timelines and with suitable consultation with relevant stakeholders. They should also be established using globally recognized common standards in order to minimize fragmentation and instead increase harmonization worldwide. We believe that initiatives based on international and harmonized standards, such as GS1, represent the most efficient way forward.
  • Systems should, at the same time, be sufficiently flexible to accommodate differences in product packaging, market size, technical infrastructure, and supply chain complexity. They should be sufficiently tested in advance of implementation dates to ensure product supply to patients is not adversely impacted as a result of system failures.
  • We stand ready to work in partnership with public authorities across the world and the World Health Organization (WHO) in establishing the most effective system in the interests of patient safety.

The Importance of Using Harmonized International Standards

EFPIA, IFPMA and PhRMA support the use of harmonized and internationally recognized standards for the identification of products. This will ensure smooth transition from current state-of-play and flexible implementation with an appreciation of the global nature of the threat. Critically, in order to maximize the efficient flow of electronic product-specific information and to minimize any negative impacts on product supply, serialization and product verification should be based on non-proprietary, harmonized international standards.

EFPIA, IFPMA and PhRMA believe that serialization initiatives should conform to the internationally recognized standards, for example a GS1 2D barcode. Using GS1 standards allows manufacturers to deploy a single set of standards across their operations and with supply chain partners, to identify and serialize products. If multiple standards are used, the complexity of operations is amplified many times, driving up costs and introducing a higher risk of error in terms of the ability for companies and governments to uniquely identify products and to facilitate product verification, including through coding and serialization of regulated medicines and tamper resistant packaging. Using GS1 standards also ensures that a single barcode can be used by several countries.