- Tous > Quality and Safety: Medicines > Counterfeit Medicines
- Tous > Quality and Safety: Medicines > Quality Assurance
- Mots-clés > counterfeit drugs
- Mots-clés > counterfeiting - measures to combat
- Mots-clés > medicine surveillance systems
- Mots-clés > pharmaceutical regulation
- Mots-clés > piracy of pharmaceuticals
- Mots-clés > quality of medicines
- Mots-clés > registration of pharmaceuticals
- Mots-clés > SSFFC medical products - surveillance and monitoring
- Mots-clés > substandard/spurious/falsely-labelled/falsified/counterfeit medicines (SSFFC)
- Mots-clés > system of surveillance and control of medicines
(2017; 77 pages)
The presence of substandard and falsified medical products in countries and their use by patients threatens to undermine progress towards meeting the Sustainable Development Goals. Such products may be of poor quality, unsafe or ineffective, threatening the health of those that take them. The problem of substandard and falsified medical products continues to increase, as globalized manufacturing and distribution systems grow ever more complex. That complexity heightens the risk that production errors will occur, or that medicines will degrade between factory and consumer. Increasing demand for medicines, vaccines and other medical products in almost every country, in addition to poor supply-chain management and the growth of e-commerce also creates opportunities for falsified medicines to be introduced into the supply chain.
Unfortunately, reliable information on the true public health and socioeconomic impacts of substandard and falsified medical products is sparse. A stronger evidence base is needed to help prevent, detect and respond to substandard and falsified medical products, and the public health threat they represent.
To estimate the true impact of substandard and falsified medical products, accurate, reliable and quality data must be systematically gathered and analysed. Therefore, the Member State mechanism commissioned a study on the public health and socioeconomic impact of substandard and falsified medical products to be carried out by the WHO. The study, together with the report on the WHO Global Surveillance and Monitoring System for substandard and falsified medical products, represent a comprehensive compilation of data related to substandard and falsified medical products and are a part of a wider approach being developed by WHO and the Member State mechanism to prevent, detect and respond to substandard and falsified medical products. These reports, together with other technical documents published by the Member State mechanism (see Box 2), contribute to the world’s evidence base and make the case for the attention of governments and investment in national medicines regulatory agencies to address this challenge.