Addendum — Fighting a Growing Global 2 Trillion USD Counterfeiting Market: The Role of Advanced Technologies in Product Safety & Secure Data Exchange

How Digital Identity, Verifiable Digital Product Passports, Traceability, and Anti-Counterfeiting Technologies are Securing Global Supply Chains and Protecting Consumers

In our article “Fighting a Growing Global 2 Trillion USD Counterfeiting Market: The Role of Advanced Technologies in Product Safety & Secure Data Exchange,” we explained the transformative power of Merging verifiable Digital product Passports (vDPPs) with Multi-factor Product Authenticity (MFPA) capabilities to improve security of our supply chains.

In this addendum we explain the application architecture in more detail.

Explanation of the Application Architecture Context Diagram

The following diagram provides an overview of the application architecture for integrating electronic Product Information (ePI) and anti-counterfeiting measures within the supply chain. The diagram illustrates the interactions and roles of various stakeholders, including regulators, manufacturers, and end-users, as well as the technical infrastructure supporting these processes.

Application Architecture Context: electronic Product Information (ePI) and Anti-counterfeiting Feature verification (Source: Spherity)

Key Components and Their Roles:

Regulator (Issuer):

• PI Approval: Regulatory bodies approve Product Information (PI) and maintain an authorized ePI product registry.
• Identity Wallet: Securely stores and manages the digital identities and credentials of regulatory bodies.

Manufacturer (Issuer, Identity Holder):

• Manufacturing & Batch Release: Involves production and initial release of product batches.
• Product Verification: Ensures that products meet the required standards and specifications.
• PI Creation & Version Control: Manages the creation and updates of Product Information.
• Anti-counterfeiting, Digital Recall, and Other Use Cases: Implements measures to prevent counterfeiting and manage digital recalls.
• Dynamic eLeaflet Version Control: Maintains updated versions of electronic leaflets.
• Identity Wallet: Securely stores and manages the digital identities and credentials of manufacturers.

End-user Agent (Verifier):

• App Business Logic: Contains the application logic for end-user interactions.
• App-to-ePI Communication: Facilitates communication between the end-user application and the ePI infrastructure.
• ePI Data Verification: Verifies the authenticity and integrity of the ePI data.
• Scanning of ePI Identifier: End-users scan product identifiers to retrieve and verify information.

Infrastructure and Processes:

• Enterprise/Regulatory Body Identity Layer: Acts as a secure layer for managing digital identities across regulators and manufacturers.
• ePI Batch# Resolver: (1) Resolves batch numbers for ePI verification.
• ePI Batch# Look-up Registry: (2) Provides a registry for batch look-ups to ensure accurate and secure information retrieval.
• ePI Batch# Data Delivery: (3) Delivers batch-specific ePI data to the end-user application.

Key Features:

a) Look-up Solution:

• Utilizes multiple instruments for performing look-ups at service endpoints.
• Ensures that look-up attacks are recognized by edge agents.

b) E2E Data Delivery & Verification Infrastructure:

• Considers network and data delivery as potentially hostile environments.
• Provides mechanisms for secure identity issuance and edge verification.
• Incorporates end-user identity obfuscation features to maintain privacy, such as client-side or server-side proxies, TOR network for onion routing, or data privacy controls on load balancers.

Workflow Summary:

1. Regulator: Approves PI and manages the authorized ePI product registry.
2. Manufacturer: Produces, verifies, and updates PI, ensuring anti-counterfeiting measures are in place.
3. ePI Infrastructure: Manages the resolution, look-up, and delivery of ePI batch data.
4. End-user: Uses the application to scan identifiers, verify data, and interact with ePI information. The end user applications authenticate the manufacturers, requests authenticity verification features and verification instructions from the manufacturer. As soon as end user applications receive this information they apply the verification instructions to verify the pharma pack.

Important note: Digital identity wallets and ATP credentialing are crucial for ensuring the security and integrity of the supply chain by enabling secure management of digital identities and credentials for authentication and authorization of real manufacturers. It is important that the end user application can authenticate and authorize the manufacturer to avoid that counterfeit manufacturers send fake authenticity verification information or send an information that the pack does not have any anti counterfeiting features.

In the US, the Open Credentialing Initiative (OCI) has laid the groundwork for identity and trust within the pharmaceutical supply chain, providing an essential prerequisite for the implementation of secure verification and anti-counterfeiting solutions.