Substandard and falsified medical products

                                  Overview

                                  Up to two billion people around the world lack access to necessary medicines, vaccines, medical devices including in vitro diagnostics,  and other health products, which creates a vacuum that is too often filled by substandard and falsified products. This problem is growing as global supply chains become more complex, meaning products manufactured in one country may be packaged in a second country and distributed across borders to be marketed or sold to consumers in a third. The growth of e-commerce also contributes to this trend by making it easier to purchase medicines online, often from unauthorized sources.

                                  WHO has identified this issue one of the urgent health challenges for the next decade given that more than one in ten medicines in low- and middle-income countries are estimated to be substandard or falsified. No country remains untouched from this issue, and WHO has received reports of substandard or falsified medical medicines, vaccines and in vitro diagnostics from all regions of the world. Both generic and innovator medicines can be falsified, ranging from very expensive products for cancer to very inexpensive products for treatment of pain.

                                  WHO Member States have agreed on a comprehensive global strategy focused on prevention, detection and response to move towards achieving increased access to quality, safe, effective and quality medical products.

                                  Impact

                                  Substandard and falsified medical products create many problems for both the individual taking the medicine and for families, the larger society, health care system and supply chain. When medicines do not work the way they should, they can fail to treat or prevent disease, contribute to antimicrobial resistance, waste precious resources and lead to a loss of confidence in medicines and distrust of healthcare providers. This can have a negative socioeconomic impact, contributing to related loss in productivity and adding expenses to the individual and national health system.

                                  They are most likely to reach patients in situations where there is constrained access to quality and safe medical products, poor governance and weak technical capacity. Although this issue impacts all countries, countries where there are weak or non-existent regulatory systems bear the greatest burden of substandard and falsified medical products.

                                  In an increasingly globalized world, no one country has sufficient resources and capacity to deal with this issue in isolation. Through global systems and processes such as the WHO Global Surveillance and Monitoring System and WHO Member State Mechanism, Member States are working together to prevent, detect and respond to substandard and falsified medical products. 

                                  Publications

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                                  Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics

                                  Post-market surveillance is a set of activities conducted by manufacturers, to collect and evaluate experience gained from medical devices that have...

                                  Policy paper on traceability of medical products

                                  This policy paper outlines the features of existing traceability systems and provides guidance on developing workable traceability regulation. In the...

                                  Implementation of post-market surveillance in cervical cancer programmes

                                  World Health Organization (WHO) recommends that the health care programmes actively contribute to post-market surveillance of the medical devices they...

                                  Access to quality medical products is a crucial element of universal health coverage. Yet, every day, substandard and falsified medical products enter...

                                  A study on the public health and socioeconomic impact of substandard and falsified medical products

                                  The presence of substandard and falsified medical products in countries and their use by patients threatens to undermine progress towards meeting the Sustainable...

                                  WHO global surveillance and monitoring system

                                  The contaminated cough medicine provides a clear illustration of the worrying problem of substandard and falsified medical products, a problem that appears to...