Supporting countries to reduce the urgent risk of falsified and diverted health products in national supply chains with a vision toward national traceability of all vaccines, medicines, and health products.
The goal of the Verification and Traceability Initiative is to enable lower and middle-income countries (LMICs) to manage the risk of falsified health products and diversion in their national supply chains, while setting the foundation for the establishment of national traceability and supply chain visibility systems in the long term.
Enables the identification of counterfeit and diverted health products by validating that a scanned GS1 compliant product pack barcode, is authentic. This helps to remove falsified products from the supply chain.
The ability to identify the origin and the various stages of product consumption and distribution, and ability to track where a product is at any given time within the distribution system.
Scanning GS1 barcoded health products enables insights into the location, consumption and stock levels of these products. This allows for easier, faster and improved reporting and reconciliation against manufacturer distribution, further aiding supply chain planning.
As COVID-19 vaccine distribution ramped up worldwide, the production and distribution of falsified and sub-standard vaccines and related COVID-19 supplies also increased. Falsification and diversion of one of the most valuable and highest-demand vaccines in history was cited as a risk by the COVAX Facility, the GAVI Audit and Finance Committee, and UNICEF, and evidence from Interpol and the Oxford Data Observatory has corroborated this.
The need for product quality verification and traceability extends beyond COVID-19 vaccines to all health products. The highest risk is in low- and middle-income country (LMIC) national supply chains, where governance structures, tools, and technical capacity for active monitoring for falsification are limited and traceability systems are either non-existent or in the early stages of development. Falsified vaccines and medicines cost LMICs $30 billion/year and over $200 billion/year globally. Current alerts of falsified and substandard medical products as published by the WHO can be viewed here.
For COVID 19 vaccines we need to be able to tell where the vaccines are coming from and which paths through the supply chain they have taken, including the time between each node of the chain.
COVID 19 vaccines, governments, funders and partners need to have information about COVID 19 vaccine stock levels and supply chains in order to ensure that the right products are available and can be transported to destinations where they are needed. The aim is to provide data to strengthen the manufacture and distribution of COVID 19 commodities and to ensure that the risk of shortages or expiration of products is minimized.
The initiative will establish a global repository of trusted health product information that can verify the authenticity of health product information sent to its application programming interface (API) or scanned using a complementary, mobile verification application. This global repository will initially be loaded with COVID-19 vaccine data from manufacturers to address the urgent risk of falsified or diverted COVID-19 vaccines. However, the repository will be designed to support end-to-end (E2E) traceability of all vaccines, HIV, TB, and malaria medicines, and other health products.
The global repository and mobile verification application are built on the GS1 supply chain standard, ensuring their interoperability with other GS1-enabled supply chain information systems. This will further allow its functionality and scope to be expanded over time to cover other health products and use cases, including traceability, product recall, and supply chain automation and analysis.
Benefits of Supply Chain Visibility:
Depending on the existing digital health ecosystem within any country, the global repository can be used through two different modalities:
Standalone Mobile Application
For countries where no existing national traceability system exists. Supply chain and health system workers can scan vaccines with a smart phone application to validate their authenticity at any time. This application will be easy to use and require minimal additional training.
Integrated with Traceability System
For countries with an existing national traceability or health product management system. Supply chain and health system workers can use their existing product scanning system, which can interface with the global repository’s API or mobile software development kit (SDK) to verify products registered in the repository.
The Initiative is led by a global steering committee comprised of several global development partners and regulatory authority leaders in the African Region, including:
The Verification and Traceability Initiative invites active discussion with all country partners involved in ensuring the quality and veracity of health products.
By mid 2022 the global repository of trusted health product information will be tested and ready to be adopted and scaled by countries. The initiative will provide direct technical and financial support to early adopter country partners in two-to-five countries, to implement and use the global repository and share lessons learned to improve the solution for other geographies. Thereafter, the global repository and related tools and guidelines will be made available in a self-service fashion.
Additional bridge funding for immediate deployments may also be available through the following COVID-19 response funding mechanisms. Interested country partners should contact their local partner offices for more information on how to use existing funding to support the global repository of trusted health product information deployment.
- GAVI: COVID-19 Vaccine Delivery Support (CDS)
- USAID: American Rescue Plan Act (APRA)
- Global Fund: Procurement and Supply Chain Strategic Initiatives
For long-term operations and scaling of the solution to cover additional health products and use cases, countries can work with initiative partners to leverage existing long-term funding vehicles, for example through Health Systems Strengthening funding provided by USAID, the Global Fund, and the World Bank to provide ongoing support to the appropriate government ministry and/or regulatory agencies.
ADDITIONAL INFORMATION AND RESOURCES
Documents in progress
These documents are currently being developed by the initiative task teams and will be published soon.
- Supply Chain Champion Role
- Data Governance Framework
- Business Processes
- Manufacturer MOU
- Dashboard User TOU
 WHO, A Study on the Public Health and Socioeconomic Impact of Substandard and Falsified Medical Products, 2017.