- All > Quality and Safety: Medicines > Counterfeit Medicines
- All > Quality and Safety: Medicines > Quality Assurance
- All > Quality and Safety: Medicines > Safety and Efficacy
- All > WHO Prequalification of Medical Products > WHO-UNICEF-UN Project
- Keywords > counterfeit drugs
- Keywords > counterfeiting - measures to combat
- Keywords > quality of medicines
- Keywords > reporting system
- Keywords > SSFFC medical products - surveillance and monitoring
- Keywords > substandard/spurious/falsely-labelled/falsified/counterfeit medicines (SSFFC)
- Keywords > system of surveillance and control of medicines
(2013; 4 pages)
The existence of substandard/spurious/ falsely labelled/falsified and counterfeit (SSFFC) medical products is not a new phenomenon, but is increasingly recognized by WHO Member States, regional groups and various international organizations as representing a significant threat to human health.
The right to safe, efficacious, quality medicines which are affordable is a fundamental human right. In some low income countries access to healthcare facilities is limited; for those fortunate enough to reach a facility they should be able to have trust and confidence in the medicines they receive. Often, this is not the case and with tragic consequences. However, this situation — which was once regarded as an issue solely affecting low and middle income countries — now impacts all. The vast profits to be made through the high demand and large turnover of medical products is a powerful driver for those engaged in the manufacture, distribution and supply of SSFFC medical products.
The rapid increase in connectivity to the Internet has also effectively opened up global markets to the distribution of SSFFC medical products. Whilst enabling access to medicines, it has also encouraged a culture of self-diagnosis and self-prescribing. Unregulated web sites have been seen in some parts of the world as a key source of SSFFC products: an issue which is impossible to regulate effectively and cannot be dealt with by one country in isolation.
Worryingly, incidents involving SSFFC products are frequently reported from hospitals, clinics, pharmacies and licensed entities within the regulated supply chain — precisely the places where patients should have the highest level of confidence that the medicines they receive are safe and effective. Every incident damages confidence in health systems, medicines and healthcare professionals.
Despite this situation, there is no accurate global assessment of the scope, scale and harm caused by the issue...