UNICEF and a range of multi-national partners have created a Verification and Traceability Initiative (VTI) aimed at reducing the risk of people in low- and middle-income countries taking fake medicines.
The partners have launched the Traceability and Verification System (TRVST), which is having a life-changing impact in low- and middle-income countries. Other members of VTI include Gavi, The Bill & Melinda Gates Foundation, the Global Fund, USAID, national regulatory authorities in Nigeria and Rwanda, Vital Wave, and the World Bank.
While these organizations work in partnership to deliver TRVST, UNICEF is the contracting partner with technology partner SolidSoft Reply, explains Grant Courtney, TraceabilityLead at UNICEF:
What we want to do is take the technology and the solutions that are available in high-income countries, such as in Europe and North America, and bring them to low-and middle-income countries.
Laying the foundations
TRVST is a global repository that holds product-specific information submitted by medicine manufacturers. Each pack has a barcode, which holds four pieces of information: a product identifier, a serial number, a batch number, and an expiry date.
The barcode and this product-specific information is part of a global standard called GS1, which allows medicine to be traced and verified through the TRVST platform. Courtney explains:
It reduces the risk of fake products getting to patients and increases supply chain visibility. In low- and middle-income countries, estimates suggest about 10% and – often up to 30% – of medicines can be fake, which puts lives at risk.
The project is helping to power verification and traceability through what Courtney calls a “clever database” at the back end, which is built by SolidSoft Reply. Manufacturers make their products, print the barcodes, and upload the data associated to those barcodes to TRVST:
Then, further down the supply chain, you can scan the medicine, and you can do a comparison between what's on that pack against and what you've got in the system.
The VTI partnership selected SolidSoft Reply because they were looking for technological solutions that used the GS1 standard, according to Courtney:
We wanted to get the whole thing up and running quickly. We needed a partner that had experience in verification and product traceability. We also needed a partner that had run projects in low- and middle-income countries before and that were using a standardised system, so any manufacturer in the world could use it.
The procurement process began in 2021 and took 12 months. The initiative went live with a minimum viable product (MVP), which focused on the ability to have an app, which is issued by TRVST, that could be downloaded to mobile devices and used to scan barcodes and verify the authenticity of medicines on the SolidSoft Reply database. Courtney says:
Those systems have to be validated and tested. The level of testing and validation in pharma is super-high. So, we needed a company that knew how to develop and run validated healthcare systems.
That capability came pretty much out-of-the-box with SolidSoft Reply because the company is already running the world's largest verification traceability system, the European Medicines Verification Organization, which began in early 2019.
Saving lives on the ground
The MVP was trialled in Rwanda and Nigeria last July. Today, the partnership is about to go live with trials in several other countries, including Liberia and Nepal. Courtney says the project faces a range of obstacles, but boosting interest in low- and middle-income countries isn’t the toughest part of the challenge:
The interest and demand is very high. What we've got to do now is get the interfaces into the manufacturers to get the data into the system. Because without that access, when we roll the technology out to scan medicine, there's no data in the system.
Donated goods arrive in a country at a central medical store, before pushed out to regional centres and teams on the ground who are providing medical intervention. Rather than dictate how the technology is used, UNICEF and its partners help countries enable the technology. Courtney explains:
TRVST gives them an ability to kickstart the process and to verify medicine using our tools. Over time, we can imagine they’ll start to trace the products through the supply chain using national systems.
In each country, individuals at the central medical stores download the approved TRVST app. The partners in VTI expect the scanning process to eventually flow through to different parts of the supply chain, including people who are administering medicines on the ground. Scanned information is sent back to TRVST’s centralised system and medicine is verified. Any potential issues are flagged to manufacturers, donors and governments, says Courtney:
It's not our products and it's not our supply chain. UNICEF effectively supplies a service to notify parties of potential problems. Manufacturers and the governments can be notified. They can then carry out investigations to find out the cause.
The project has focused on UNICEF-provided vaccines so far. UNICEF procures about $4 billion of vaccines every year. With the foundations in place, the aim now is to provide verified medicines to more people in a range of countries:
You're trying to put tools in the hands of people that are in countries with complex supply chains and challenging environments. There are so many moving parts – you've got all of the manufacturers, the governments, the donors, the supplier organisations, and you've got the IT providers.
Getting all these moving parts to move as one means trusted partners are essential. Courtney advises other digital leaders working on similar large-scale projects to ensure they have a strong relationship with the IT provider:
Build the relationship and invest in your IT provider. Make sure that they really understand what you're trying to do and what your needs are – upskill them with that information while you get upskilled on what the technology can do.