MSF Statement on EB 152/7 - Substandard and falsified medical products
MSF witnesses the issue of substandard medical products in countries where we work. While improved data on the prevalence of the problem are needed, its root cause is well-known: regulatory systems in producing and importing countries.
Key manufacturing countries, particularly low- and middle-income countries (LMICs), should actively participate in the WHO regulatory systems strengthening programme to establish their maturity level (ML) for both medicines and vaccines, working towards becoming WHO-listed authorities (WLAs).
Importing countries can rely on WHO Prequalification (PQ). For medical products outside the PQ scope, ML1/2 countries should consider relying on authorities transitioning towards becoming WLAs.
The link between Member State Mechanism (MSM), WHO Global Surveillance and Monitoring System (GSMS), Regulatory Systems Strengthening (RSS) / Global Benchmarking Tool (GBT) and PQ is unclear; they should be integrated to best ensure a significant decrease in the circulation of substandard medical products.