Substandard and falsified medical products: WHO Activities
9 December 2019 | Questions and answers
WHO provides the secretariat to the Member State Mechanism to address SF medical products. This is a member states forum who have agreed an 8 point work plan to increase co-operation, collaboration and co-ordination, increase capacity and awareness and encourage surveillance and information sharing to fight SF medical products
WHO has launched a global surveillance and monitoring system to encourage countries to systematically report incidents involving SF medical products. The objective is to provide immediate technical support and coordination in emergencies, but also to establish a validated body of evidence of incidents to identify vulnerabilities and make policy recommendations. WHO have conducted regional and national workshops training regulatory, pharmacovigilance and laboratory specialists from Member States in the use of the system and building capacity in the prevention, detection and response to SF Medical Products. This system has already led to the provision of technical support to member states, access to laboratory testing facilities and issue of international medical product alerts. The system will be rolled out to more member states.
WHO will continue to work with member states to develop evidence based policy, strengthen regulatory capacity, improve reporting and vigilance and encourage multi-stakeholder collaboration to tackle SF medical products.
The Member State Mechanism is the global forum at which Member States can convene, coordinate, decide and organise activities to address SF medical products.
It was established in order to protect public health and promote access to affordable, safe, efficacious and quality medical products, through effective collaboration among Member States and the Secretariat, the prevention and control of substandard and falsified medical products and associated activities.
The Global Surveillance and Monitoring System for SF medical products was launched in 2013. It is open to all Member States and the largest procurement agencies have been sensitized in the use of the system. Roll out is continuing and its purpose is two-fold,
To provide technical support in emergencies, link incidents between countries and regions, and issue WHO medical product alerts.
It is designed to encourage trained focal points in National Regulatory Agencies and International Procurement Agencies to report incidents involving suspected SF medical products in a systematic and structured way to WHO. These reports permit a fast response to emergencies and the issue of alerts in the most serious cases. It also permits in depth analysis of the medical products most at risk, vulnerabilities and weaknesses in health systems, the harm caused to public health and the need for investment, capacity building and regulatory strengthening. All of which assists in developing evidence based policy.
The principal objective of a WHO medical product alert is to ensure a timely, proportionate, and consistent response to health events arising from SF medical products which represent a significant threat to International public health.
The Surveillance and Monitoring unit within the Safety and Vigilance Team of the Essential Medicines and Health Products Department will take the following criteria into account before issuing a Medical Product Alert:
- Has the report been validated?
- Does a genuine and significant risk to public health exist?
- Does the risk extend beyond the Country where the product was discovered?
- Have any warnings or alerts concerning the product subject of this incident already been issued, and if so where?
- Have adequate steps already been taken to remove the product from the supply chain?
- Is the report recent or is it likely the product remains in circulation?
Substandard: Also called “out of specification”, these are authorized medical products that fail to meet either their quality standards or specifications, or both.
Unregistered/unlicensed: Medical products that have not undergone evaluation and/or approval by the National or Regional Regulatory Authority (NRRA) for the market in which they are marketed/distributed or used, subject to permitted conditions under national or regional regulation and legislation.
Falsified: Medical products that deliberately/fraudulently misrepresent their identity, composition or source.
- Seventieth World Health Assembly update, 29 May 2017
- Working Definitions Document approved by the Seventieth World Health Assembly
pdf, 203kb - Definitions of SF Medical Products
WHO are not the competent organization to deal with the Criminal Investigation or prosecution of those involved in the manufacture, distribution and supply of SF medical products. It is a National responsibility to conduct criminal investigations. Countries are also able to call upon assistance from INTERPOL and EUROPOL in coordinating International Investigations against SF medical products who both have specialist personnel dealing with falsified medicines.
When WHO are notified of an SF medical product by a Member State we will always ask if the genuine manufacturer (innovator or generic) is known and has been contacted. If requested by a Member State WHO will contact the manufacturer to establish the facts. Samples of the suspect medicine may be sent to the genuine manufacturer for laboratory analysis. Where appropriate WHO will always contact the genuine manufacturer, in addition to a quality control laboratory, if the SF product is imitating a WHO pre-qualified product, or if WHO is considering issuing a global medical products alert.
Both of these law enforcement organizations carry out operational activity to tackle SF medical products.
Whilst WHO does not participate in these operations, it is important to better understand precisely which medical products are being seized and clarify which are unlicensed, substandard or falsified products. It is also necessary to ensure a focus on public health and determining if an immediate and serious risk exists in relation to any seized products. Some of these operations take place at ports of entry and some within the market place.
It is also important to validate the information gathered by these organizations and assess more accurately the scope, scale and harm caused by SF medical products, informing post market surveillance in countries and identifying the medical products most at risk.