Medicinal products are an appealing target for illicit trade, with an estimated annual cost of $200 billion and potentially millions of lives lost. The problem affects low- and middle-income countries (LMICs) disproportionately, and the World Health Organisation (WHO) estimates that 10% of medicines in LMICs are substandard or falsified.
These counterfeit medicines may use fake packaging and labelling, contain lower quantities of active ingredients, or unlabelled and potentially harmful compounds. Ultimately, these may result in adverse reactions and poorer outcomes, undermining public confidence in healthcare.
The COVID-19 pandemic illustrated vulnerability in the global supply chain. Falsified COVID vaccines were found in Africa and South-East Asia. Seizures of substandard and falsified COVID medicines were made in Mexico, South Africa, and the US.
The pandemic emphasised the emerging problem of supply chain shortages across the globe. Medicine shortages are a major incentive for falsification, as illustrated by the recent issues in Austria and the UK with falsified Ozempic pens used to treat diabetes and obesity.
The pandemic focused energy and attention on strategies and initiatives to deliver safer medicines for everyone. This is a lasting and positive legacy of the COVID era with wide implications across the entire healthcare landscape. Governments, manufacturers, and distributors are adopting advanced systems to detect falsified and substandard products and ensure the authenticity, legality, and safety of their drugs before they are supplied to the public.
TRVST and EMVS
The Traceability and Verification System for Health Products (TRVST) is the world’s first global medicines verification system, launched by Solidsoft Reply, specialists in medicine verification and traceability software in collaboration with national medicine regulatory authorities. Emerging from the accelerated roll-out of the global vaccine programme during the COVID-19 pandemic, TRVST combines verification with traceability to increase visibility across the pre-country pharmaceutical supply chain and promote authentication at the national level.
TRVST operates primarily in low- and middle-income countries. It is an extension of work to introduce medicine verification across Europe. The European Union’s Falsified Medicines Directive, introduced in 2011, harmonised legislation across Europe and mandated drug companies to ensure their medicines are verifiable at the point of dispensing across the bloc. This is enabled by the European Medicines Verification Systems (EMVS), a European-wide system to detect, identify, and eliminate falsified medicines.
Serialisation, tracking, and verification
The simplest safeguard is to serialise medicinal products and print a unique identifier barcode on the outer packaging of each item. Each identifier can be checked against a trusted repository of data provided by pharmaceutical manufacturers. Barcode scanning is a cost-effective technology used widely throughout the supply chain and at the point of dispense. Mobile devices extend verification to members of the public, providing greater assurance to patients.
The TRVST system creates a ‘digital twin’ for each commissioned medicine pack, allowing it to be tracked across the supply chain until it is supplied or decommissioned. This helps determine the origin of each pack and detect unusual movements or events that may signify falsification or diversion.
Every drug manufacturer, parallel distributor, wholesaler, hospital, and pharmacy can connect to the system, enabling medicine traceability throughout the supply chain, and extending verification, even to the patient’s home. When a clinician or patient scans the barcode, they confirm the authenticity of the medicine pack. If the unique identifier fails the test, alerts are sent to manufacturers, helping them identify potential falsification or diversion and providing visibility to regulatory authorities. The system also reports expired or recalled batches, ensuring that substandard products are never used.
Technology, standards and integration
It is perhaps surprising that the same technology framework can easily be adapted to very different landscapes. The European Union implements a highly regulated approach, harmonised under European law.
TRVST addresses the needs of countries that have more limited regulatory control over the pharmaceutical sector and where serialisation and verification are applied on a voluntary basis. The EMVS is a ‘backstop’ that detects falsified medicines at the point of dispense when all other measures have failed. In LMICs, where the problem of substandard and falsified medicines is most acute, TRVST emphasises the analysis of data to detect patterns that indicate falsification and diversion.
The system applies recognised global standards and deliver verification services across the world using Microsoft Azure as a scalable and cost-effective cloud-based platform. This minimises the cost-per-pack of verification and maintains performance. Price sensitivity is most acute in LMICs, and we actively pursue ways to reduce costs through modularised, multi-tenancy approaches that meet different needs while maintaining scalability, and reliability.
We also promote GS1 standards for barcode-based serialisation, traceability (EPCIS) and access to information and services via GS1 Digital Links. These provide the most widely adopted standards across the pharmaceutical supply chain. By employing these standards, we help to further reduce costs and complexity.
Our focus has shifted over time to the role of medicine verification systems in wider ecosystems. Europe focuses considerable energy on tackling shortages within the supply chain. Systems such as the EMVS can potentially act as early warning systems to highlight emerging issues.
In LMICs, there is an urgent need to integrate with Logistics Management Information Systems and other technologies that are revolutionising the pharmaceutical landscape. Verification systems tackle fraud and diversion as well as falsification. They also enhance patient safety by providing timely and accurate information directly to patients via mobile devices. They can gather real-world evidence to support pharmacovigilance, and they can play a critical role in enabling a decentralised, integrated network of protection that national and organisational boundaries.
The technical framework, originally developed for Europe, fits the LMIC context well. However, the LMIC context is very different. Greater emphasis is placed on analytics and integration with other systems to safeguard national supply chains.
There are demanding requirements for secure data access and visualisation by different stakeholders, and a need to deliver verification and medicine safety services directly to patients in appropriate forms and languages. This requires agile DevOps and good user interface design that carefully considers the needs of end users. It is perhaps unsurprising that verification systems for LMICs are beginning to support a wider range of features than systems used in high-income regions.
The future of authentication and safety
Our attention is focused on practical ways to provide better verification and traceability technologies to LMICs at a realistic cost. Modern technology has the potential to have a major impact on the global scourge of substandard and falsified medicines and bring greater protection and assurance to millions across the globe. However, this will only happen with imagination, clear thinking, and a bold approach.
By leveraging cutting-edge technologies and collaborating with regulatory authorities, EMVS and TRVST help ensure that patients receive genuine, safe, and effective medicines, ultimately contributing to better health outcomes and reduced economic losses due to substandard and falsified drugs.
