WHO Role
Secretariat – Member State Mechanism
In accordance with the Constitution of the World Health Organization and a number of World Health Assembly resolutions relating to the quality, safety and efficacy of medicines, specific resolutions began to emerge relating to what was then known as counterfeit medicines.
WHA 41.16 (1988) requested WHO to ‘initiate programmes for the prevention and detection of export, import and smuggling of falsely labelled, spurious and counterfeited or substandard pharmaceutical preparations, and to co-operate with the Secretary General of the UN in case provisions of the International Drug Treaties are violated’.
WHA 47.13 (1994) requested WHO ‘To support Member States in their efforts in combating the use of counterfeit drugs’
WHA 65.19 (2012) requested WHO to establish a Member State Mechanism to address the issue of Substandard, spurious, falsely labelled, falsified and counterfeit medical products.
WHO provides the Secretariat for the Member State Mechanism which has agreed a work plan, priorities and has commenced work in a number of areas
Global Surveillance and Monitoring System for SF Medical Products
WHO launched a global surveillance and monitoring system for SF medical products at a workshop held in West Africa in July 2013.
The system allows WHO to offer immediate technical assistance in emergencies, link cases and connect focal points from around the world.
The system also accumulates a validated body of evidence which allows more detailed analysis, identifying the medical products most at risk, weaknesses in systems and vulnerabilities in the supply chain. This analysis provides a more detailed assessment of the scope, scale and harm caused by SF medical products. It also supports evidence based policy and investment in targeted capacity building, and informs more directed post market surveillance and informs the work of the Member State Mechanism.
WHO Medical Product Rapid Alerts
WHO publishes medical product rapid alerts in cases where there is a serious risk to public health affecting a wide geographic area.
Criteria influencing the issue of an alert include validation that the medical product is SF, evidence of recent or continued circulation, or evidence that adequate steps have not been taken to inform healthcare professionals and consumers or remove the SF medical product from the supply chain.
The alerts can be found on the WHO website or you can sign up for the alerts to be sent automatically to your e mail address
Capacity Building and Regulatory Strengthening
WHO has a key function in strengthening National and Regional Medicines Regulatory Authorities in preventing, detecting and responding to SF medical products.
This takes the form of issuing guidance and delivering training across a broad range of regulatory requirements including: