Track & Trace systems aim to trace counterfeit medicines. In many parts of the world, this procedure is already common practice, for example in the EU or the USA. The TRVST system is an initiative of UNICEF and others and is intended to restrict the trade in counterfeit and substandard medicines in the long term, thereby increasing patient safety in low-income countries.
However, the situation is different in countries without track & trace systems. According to the World Health Organization, around 10% of medical products in low- to middle-income countries are either counterfeit or of inferior quality. These are often also the countries with no regulations for tracking and tracing medicines. TRVST (Traceability and Verification System) is intended to help here.
What is the TRVST system?
In the wake of the increased incidence of counterfeiting during the COVID-19 pandemic, the Verification & Traceability Initiative (VTI) set itself the task of combating this issue. Consisting of various organizations such as UNICEF, the Bill & Melinda Gates Foundation, and the World Bank, the VTI has introduced a database called the Global Trust Repository (GTR). Here, data is stored to validate the authenticity of vaccinations, medicines, and other medical products. The Traceability & Verification System for Health Products, or TRVST, enables the validation of data and consists of five elements:
- standard interface for connection to manufacturers
- Global Trust Repository (GTR)
- smartphone app for on-site verification
- TRVST Dashboard
- TRVST interface for verification and tracking with the national systems
Product data is sent to the programming interface (API) of the GTR or scanned using a supporting, free verification app (already in use). Specially implemented national systems can thus track movements along the supply chain. The GTR database supports the end-to-end traceability of all vaccines, HIV, tuberculosis, malaria medicines, and other healthcare products. For traceability, the TRVST system uses the common GS1 standards. It will also be possible to retrieve digital package leaflets. Thanks to the VTI, development will also be supported in countries already working on verification and traceability. Both the GTR and the verification app are options in the range of country approaches recommended by the WHO to protect patient safety.
So far, however, TRVST is only designed to verify the supply chain data of donated products. It is not yet clear whether more comprehensive tracking will be possible.
The effects of counterfeit medicines
Counterfeiting is already common practice in many parts of the world. With the Falsified Medicines Directive (EU-FMD), the European Union adopted a corresponding regulation in 2013. In the United States, it was the Drug Quality and Security Act (DSCSA, 2013). The reported counterfeits in these countries are comparatively very low. Thanks to the regulations, suspicious medicines do not even come onto the market, as they are quickly withdrawn from circulation anyway. According to estimates, counterfeit and substandard drugs cost low-income countries around 30 billion dollars a year. Globally, the figure is said to be over 200 billion dollars.
One example of the impact of these drugs relates to the treatment of pneumonia. It is estimated that up to 169,000 children under the age of five die each year from the disease while being treated with these drugs. In connection with the treatment of malaria, there are up to 116,000 deaths. In addition, costs of approximately 38.5 million dollars are incurred due to complications with counterfeit and substandard medicines.
The problem with counterfeit medicines also became apparent during the COVID-19 pandemic. There was a huge global demand, but the supply could not keep up with production, which was particularly noticeable in Africa. In southern Africa alone, counterfeit products worth 3.5 million dollars were confiscated between July and August 2021. Among the products were masks, COVID-19 tests and vaccinations. Such counterfeits pose a threat to public health.
What are the benefits of TRVST?
The benefits of the TRVST system are clear. Movements along the supply chain become visible, which helps to increase their efficiency. Government agencies are further supported and focused action is taken to mitigate risk by preventing the flow of counterfeit healthcare products into national supply chains. As a result, patient safety is improved, which is the absolute focus of the efforts. However, the introduction of this project has another major advantage. It creates the prerequisites for the implementation of national track & trace systems in the participating nations. In the future, this could simplify product recalls, prevent drug shortages, and improve pharmacovigilance.
Which countries are taking part?
Four phases characterize the progress of discussions with individual countries. Those in the most advanced Group 1 are in the process or have already implemented the TRVST system. This is followed by Group 2, in which an interest in participating has been confirmed and implementation is being initiated. Group 3 represents the countries in which discussions with the relevant authorities have already been held or have been planned. There is contact with Group 4, but no discussions have taken place.
| Group 4 | Group 3 | Group 2 | Group 1 |
| 1. Burkina Faso 2. Cameroon 3. Kenya 4. Namibia 5. Sierra Leone 6. South Sudan 7. Togo 8. Uganda 9. Zimbabwe 10. Burundi 11. Pakistan 12. Côte d’Ivoire 13. Benin | 1. Ghana 2. Ethiopia 3. Egypt 4. Philippines 5. India 6. Zambia 7. Senegal | 1. Nepal 2. Malawi 3. Liberia 4. Tanzania 5. Madagascar 6. Botswana | 1. Nigeria 2. Rwanda |
With the TRVST system, the Verification & Traceability Initiative is attempting to increase patient safety in low- to middle-income countries. It is therefore to be hoped that other countries will join this project. The effects and consequences of counterfeit and substandard medicines are particularly devastating for countries with a weak healthcare infrastructure.
[Disclaimer]
This information is only one possible interpretation of the regulations. They are also in a constant state of change, so the information in this article may be incomplete or out of date. The above article is expressly no legal advice. Please refer to the official documents for information before making any business decisions. (Status of information: May 2024)